E_FPAR 2.0 60D Comments and Responses

Comment Text	Response Text
The overall purpose and intention behind collecting additional and encounter-level data elements is unclear. Significantly more meaningful research into the overall magnitude and consequences of proposed FPAR 2.0 changes (particularly on providers, clinics, and patients), and whether the changes will ultimately improve the Title X program, is needed.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Many of the proposed FPAR 2.0 data elements do not adhere to modern sexual and reproductive health clinical guidelines and are concerning from the perspective of establishing and maintaining trust with diverse Title X patient populations over time.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Many of the proposed FPAR 2.0 data elements risk breaching patient trust, confidentiality, and privacy, particularly for minors and individuals who are undocumented. Data “masking” will likely not lessen these concerns because of continued sensitivity and trust concerns when sharing data with the federal government.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Many of the proposed FPAR 2.0 data elements, particularly those inquiring as to a patient’s sexual activity, administrative sex, and/or intention to become pregnant, are repetitive, intrusive, and unnecessary. There is significant potential the proposed elements will hinder and/or harm trusted provider-patient relationships, especially given the sensitive nature of sexual and reproductive health. Many of the proposed elements should not be collected at the federal or state level, and some could be considered as protected health information.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Many of the proposed FPAR 2.0 data elements, which are medically unnecessary, will also hinder the ability to provide effective and quality family planning services, including comprehensive contraceptive and/or preconception counseling, during a telehealth visit, which typically lasts only 20 minutes.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
It is unclear which proposed FPAR 2.0 data elements will be required or optional. This makes preparing for a FPAR 2.0 launch (both at the grantee and service site level) difficult.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Collecting itemized data for sexually-transmitted infection testing and other procedures will require significant changes to clinical workflows, which will add considerable additional burden to clinics already operating with high turnover, limited numbers of providers, and limited budgets.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Appropriate clinical care would require the recording of such data. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
Many providers will need to make cumbersome and complex changes to their electronic health record (EHR) systems, which can be expensive and place a high cost burden on clinics already providing critical family planning services under a limited budget to communities in need.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
The proposed FPAR 2.0 data elements will overburden providers with reporting requirements, as Title X is not the only federal program that requires significant data submission and reporting. Many Title X providers receive funding from other such federal programs/providers. Many providers may consider leaving the Title X program due to the considerable level of time, effort, and funding needed to comply with proposed FPAR 2.0 changes.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Additionally, we request this rule be postponed until additional research into the overall magnitude and consequences of FPAR 2.0 can be conducted and/or additional support for Title X grantees and service sites can be provided.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While Converge appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused. At the same time, OPA must plan and initiate a new process for transitioning to a new data collection and reporting system with continued stakeholder involvement.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Under the best of circumstances, OPA’s proposal for FPAR 2.0 is flawed. Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077);	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
At this time – against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule – implementation of FPAR 2.0 simply is not feasible. We are working hard to hold on, rebuild, and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Converge requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all Title X grantees and service sites currently are facing. Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Converge requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study , was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the data collected no longer being relevant.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
OPA has not collated recent feedback from the Title X network regarding costs associated with encounter-level data collection and the proposed new FPAR 2.0 data elements. Estimates in the FPAR Burden Study, where gross non-labor costs were estimated to be $163,300 (or $2,207 per respondent) and annualized labor costs were estimated at $106,880 (or $1,444 per respondent) , are based on the cost and time burdens of implementing a new FPAR system that reports data aggregately (as opposed to encounter-level data reporting and collection). It is inappropriate for OPA to use data collected from the 2009 FPAR Burden Study to quantify costs for implementing the encounter-level data reporting system currently proposed, as these estimates relate to a completely different iteration of the proposed overhaul of FPAR that would be substantially less burdensome on grantees and subrecipients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff. .
Converge believes the 23 additional elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. We ask for additional opportunities to provide feedback on what additional data elements are feasible to add to the current FPAR clinic visit record and would be most helpful to us for program management and quality improvement.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Management of the Title X program entails monitoring progress towards performance goals required by the 1993 Government Performance and Results Act (Pub. L. 103-62), which include: giving priority in the provision of family planning services to low-income individuals, reducing invasive cervical cancer through Pap testing, reducing infertility through chlamydia screening, and increasing program efficiency by monitoring the cost of care. However, with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
It corresponds to the deliberate transition of FPAR from a program monitoring tool to a research dataset, requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,” they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Future Pregnancy Intention Reported The inclusion of reported pregnancy intention as a reportable data measure fails to address the well documented reality of pregnancy ambivalence. Very few people conceive of pregnancy decision making in the very formal time limited way that One Key Question and other intention assessments frame this. In addition to the unacceptable focus on intention, collecting data on how people state their desire for a pregnancy does not speak to their contraceptive decision making as often these elements are not directly related. As the Title X program continues to address the need for noncoercive and equitable care, it is critical to properly address contraceptive decision making as person-centered and driven by preferences stated by the client. Patients themselves have stated a preference for shared decision making that is guided by their preferences and the medical input of their provider A continued focus on “pregnancy intention” leads can lead to a focus on method effectiveness to prevent pregnancy that may not be at all guided by patient preference for contraceptive methods. Thus, collecting intention around pregnancy both generates data that does not actually mean very much with relation to patient decision making and it may have the unintended consequence of encouraging non-equitable and even coercive counseling practices.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Lack of Data: No Patient Reported Measures FPAR 2.0, like previous FPAR data and many other large efforts to generate data on healthcare utilization fails to collect any data from patients themselves. This lack of patient input speaks to a very narrow focus on clinical outcomes and practices while failing to properly address the critical element of how patients experience this federally funded health care program. In particular on the topic of family planning and reproductive healthcare, there is a lengthy history as well a contemporary reality of coercion and abuse. Failing to value the reported experiences of patients equally with medical health record data does nothing to protect against the possibility of care that is harmful. Converge would propose the uniform usage of a patient reported measure that speaks to the patient-centeredness of care provided. The Patient-Centered Contraceptive Counseling measure is one such tool that could be used throughout the Title X program to ensure patient input is being collected and valued. The measure is validated by the National Quality Forum.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Additionally, the Patient-Centered Contraceptive Counseling (PCCC) Measure is not intended to be implemented within an EHR specification so it cannot be implemented within the FPAR 2.0 EHR specifications. OPA has plans to develop technical assistance to work with grantees to implement the PCCC when certain thresholds of utilization.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health. However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]. These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals. It is important to emphasize that patients accessing services in non-Title X settings would not be asked to provide responses to these personal, guideline-unconcordant questions at every visit, nor would their responses be reported at the encounter level to the federal government. When the federal government begins collecting research data for its benefit and requires those accessing services through the safety net to provide such information as a precursor to receive care, it exacerbates medical mistrust, potentially dissuading patients from coming to us for needed services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive. It is critical to underscore that ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors are dependent on patient age and other risk factors that support screening. As a result, none of these cervical cancer screening-related data elements can be used to monitor adoption and adherence to screening guidelines or track progress towards Healthy People 2030 goals (i.e., increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines), as described in the Supporting Statement for the Title X FPAR 2.0. When extracting data to calculate measures, there is no way to qualify whether an appropriate screening interval was applied.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
New Data Elements: Cardiovascular Risk Factors FPAR 2.0 suggests that Title X service sites collect and report on five different data elements related to cardiovascular health: Systolic blood pressure, Diastolic blood pressure, Height, Weight, and Smoking status (detailed as ever smoker, ex‐smoker, smokes daily, occasional smoker, smoker, status unknown, heavy smoker, light smoker). Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines. Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force. Converge believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0. Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences. Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination. Patients accessing health services in non-Title X settings are not weighed at every visit unless clinically indicated. Title X patients should receive the same standard of care and should not be subject to weight stigmatization at every visit. Weight stigma invokes psychological stress and emerging research suggests that this stress leads can exacerbate poor physical health outcomes for obese individuals , with the potential to perpetuate racial/ethnic and socioeconomic health disparities in overweight and obesity. It is time to move away from this measure and focus on measures of health that are scientifically valid and designed for diverse patient populations. Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for additional patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Converge requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services. Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0. While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take. Despite a range of opinions about what qualifies as sensitive health information, it generally is information that carries with it unusually high risks in the event of disclosure. Several data elements within FPAR are sensitive in nature, as they relate to sexual behaviors and other deeply personal topics.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While Denver Health appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused. At the same time, OPA must plan and initiate a new process for transitioning to a new data collection and reporting system with continued stakeholder involvement.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Under the best of circumstances, OPA’s proposal for FPAR 2.0 is flawed. Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077)	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
it puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
At this time, implementation of FPAR 2.0 simply is not feasible. Like all safety net providers, Denver Health has experienced challenges related to the COVID-19 public health emergency, including prioritizing testing and treatment; implementing telehealth services; cost of personal protective equipment (PPE); and vaccine distribution for communities. Any attempt to implement FPAR 2.0 in accordance with current timelines will disrupt our ability to respond to these top priorities.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Denver Health requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all Title X grantees and service sites currently are facing. Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
To implement FPAR 2.0, Denver Health would need to make upgrades to its information technology (IT) infrastructure, However, as of 3/27/2021 OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
After making system upgrades, Denver Health will require several months to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Initiating upgrades before final specifications are available would be wasteful, as inconsistencies would require revisions that would carry additional costs and burden hours spent.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Denver Health requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study, was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the data collected no longer being relevant.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
OPA has not collated recent feedback from the Title X network regarding costs associated with encounter-level data collection and the proposed new FPAR 2.0 data elements. Estimates in the FPAR Burden Study, where gross non-labor costs were estimated to be $163,300 (or $2,207 per respondent) and annualized labor costs were estimated at $106,880 (or $1,444 per respondent)2, are based on the cost and time burdens of implementing a new FPAR system that reports data aggregately (as opposed to encounter-level data reporting and collection). It is inappropriate for OPA to use data collected from the 2009 FPAR Burden Study to quantify costs for implementing the encounter-level data reporting system currently proposed, as these estimates relate to a completely different iteration of the proposed overhaul of FPAR that would be substantially less burdensome on grantees and subrecipients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Denver Health believes the 23 additional elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. We ask for additional opportunities to provide feedback on what additional data elements are feasible to add to the current FPAR clinic visit record and would be most helpful to us for program management and quality improvement.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Management of the Title X program entails monitoring progress towards performance goals required by the 1993 Government Performance and Results Act (Pub. L. 103-62), which include: giving priority in the provision of family planning services to low-income individuals, reducing invasive cervical cancer through Pap testing, reducing infertility through chlamydia screening, and increasing program efficiency by monitoring the cost of care. However, with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
It corresponds to the deliberate transition of FPAR from a program monitoring tool to a research dataset, requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,”4 they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health.5 However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)].6 These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals. It is important to emphasize that patients accessing services in non-Title X settings would not be asked to provide responses to these personal, guideline-unconcordant questions at every visit, nor would their responses be reported at the encounter level to the federal government. When the federal government begins collecting research data for its benefit and requires those accessing services through the safety net to provide such information as a precursor to receive care, it exacerbates medical mistrust, potentially dissuading patients from coming to us for needed services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.7 Furthermore, there is no way for Denver Health to differentiate whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance. It is critical to underscore that ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors are dependent on patient age and other risk factors that support screening.8 As a result, none of these cervical cancer screening-related data elements can be used to monitor adoption and adherence to screening guidelines or track progress towards Healthy People 2030 goals (i.e., increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines), as described in the Supporting Statement for the Title X FPAR 2.0.9 10 When extracting data to calculate measures, there is no way to qualify whether an appropriate screening interval was applied.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors FPAR 2.0 suggests that Title X service sites collect and report on five different data elements related to cardiovascular health: Systolic blood pressure, Diastolic blood pressure, Height, Weight, and Smoking status (detailed as ever smoker, ex‐smoker, smokes daily, occasional smoker, smoker, status unknown, heavy smoker, light smoker). Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines. Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.11 Denver Health believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.12 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.13 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.14 Patients accessing health services in non-Title X settings are not weighed at every visit unless clinically indicated. Title X patients should receive the same standard of care and should not be subject to weight stigmatization at every visit. Weight stigma invokes psychological stress and emerging research suggests that this stress leads can exacerbate poor physical health outcomes for obese individuals15, with the potential to perpetuate racial/ethnic and socioeconomic health disparities in overweight and obesity. It is time to move away from this measure and focus on measures of health that are scientifically valid and designed for diverse patient populations. Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for additional patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Element: National Provider Identifier (NPI) While most advanced practice clinicians have an NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act- (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI. Title X family planning encounters at Denver Health are routinely performed by other providers, including registered nurses and health educators. As such, many of our providers delivering Title X services do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
Confidentiality of Sensitive Personal Health Information Denver Health requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.16 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.17 While encounter-level data will be deidentified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take. Despite a range of opinions about what qualifies as sensitive health information, it generally is considered to be information that carries with it unusually high risks in the event of disclosure. Several data elements within FPAR are sensitive in nature, as they relate to sexual behaviors and other deeply personal topics.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
While we agree that the Title X program needs a more contemporary data system for monitoring and improving program performance, such an endeavor cannot come at the expense of serving those in need of services, specifically patients who are low-income, uninsured, and underinsured. Such an effort also cannot come at the expense of providing Title X patients with the same standard of care as their counterparts who receive care in non-Title X settings, which is just what FPAR 2.0 - with burdensome and unnecessary data elements that are required for every visit – would do. Accordingly, Denver Health urges OPA to pause and re-evaluate FPAR 2.0.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While the WHC appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused. At the same time, OPA must plan and initiate a new process for transitioning to a new data collection and reporting system with continued stakeholder involvement.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
FPAR 2.0 puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
At this time – against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule – implementation of FPAR 2.0 simply is not feasible at this time. We are working hard to hold on, rebuild, and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Like all safety net providers, WHC has experienced several challenges since 2019. The Wyoming Title X network saw one service site withdrawal which resulted in a loss of over 800 being served in one community over the restrictions related to abortion services. Our eight (8) subrecipients experienced a 24% decrease in unduplicated clients and a 23% decrease in total encounters as a result of COVID-19.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
WHC requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all Title X grantees and service sites currently are facing. Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently, we estimate it will take 12-18 months to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0. This includes required steps to upgrade systems, which may include processes related to vendor procurement, adopting and implementing a new electronic health record (EHR) or electronic data collection system to report encounter-level data, customizing existing systems so the FPAR 2.0 data elements map to existing standardized value sets, data validation efforts, etc.	Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To address implementation burden, OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed to help transition.
After making system upgrades, WHC and its subrecipients (which operate eleven (11) service sites) will require a minimum of six to eight (6-8) months to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed. Initiating upgrades before final specifications are available would be wasteful, as inconsistencies would require revisions that would carry additional costs and burden hours spent.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Current OPA timelines also assume a level of baseline technology at both the Title X grantee and subrecipient levels. However, 2 of our subrecipients have not yet adopted EHR systems and one of these subrecipients has only 1 administrative/financial and 1 clinical staff. Instead, these organizations use paper forms to collect FPAR data for aggregate submission. Those service sites without EHRs will not be able to begin reporting FPAR 2.0 data electronically on January 1, 2022, as EHR implementation typically takes 9 to 11 months, with three months for planning and six to eight months for implementation. Instead, if FPAR 2.0 goes into effect on that date, they will need to collect and perform manual data entry of FPAR 2.0’s 45 proposed data elements for every visit, and then determine how to de-identify line-item records so that they can be transmitted securely. This cumbersome process not only raises concerns about the effective use of Title X resources, but also about the security and confidentiality of clients’ sensitive health information.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff. Flat-file specifications will also be provided to help those without EHR systems.
WHC requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
WHC estimates that implementing FPAR 2.0 as proposed at the grantee-level will amount to over $75,000.00 in one-time non-labor costs. This estimate is based on initial estimates for program data assessment, data program installation, and training. Furthermore, WHC estimates that each of its eight (8) subrecipients will outlay an average of $7,036.00 in non-labor costs to implement FPAR 2.0, for an estimated total of $56,288.00 in non-labor costs across this single Title X grantee network. This comes during the same fiscal year(s) as the COVID-19 public health emergency when resources have been redirected to emergency response and revenue has dwindled due to decreases in patient census. These cost estimates do not include ongoing expenses such as computer and software upgrades and purchased service costs.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
All of our programs rely on some state funding to support various program activities. This year, all state programs were required to cut 20% of their budgets. The result may be that local, county and state governments will have less dollars at their disposal to support Title X program.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
WHC has been unable to realistically assess one-time labor costs to implement FPAR 2.0. The reality is that the Grantee has 2 full time staff (Executive Director and Clinical Director) and two part-time staff whose responsibilities do not include FPAR data. This estimate is based on the cost of the Executive and Clinical Directors working a combined 200 hours on tasks related to implementation, which may include: selecting and/or creating a contract with a vendor, working (with vendors) to perform necessary system upgrades and map out FPAR 2.0’s data elements to existing standardized value sets, training health care providers and staff on how to collect new data elements, conducting preliminary data collection, running reports to ensure data mapping is correct, and performing quality assurance of preliminary data collected]. For grantees: We also estimate that each of our eight (8) subrecipients will spend an average of eighty (80) hours implementing FPAR 2.0, for an estimated total of 840 hours in one-time labor costs across this single Title X grantee network.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
OPA is proposing this time commitment take place when we are continuing to respond to – and facing burnout from – the COVID-19 public health emergency. Costs for ongoing operations and maintenance are not included in these estimates. They also do not include the additional time it will take health care providers and staff at Title X service sites to document more than 20 additional data elements as part of every single Title X visit.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
WHC believes the 23 additional elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. We ask for additional opportunities to provide feedback on what additional data elements are feasible to add to the current FPAR clinic visit record and would be most helpful to us for program management and quality improvement.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. ow to conduct a family planning encounter.
OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]. These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
When the federal government begins collecting research data for its benefit and requires those accessing services through the safety net to provide such information as a precursor to receive care, it exacerbates medical mistrust, potentially dissuading patients from coming to us for needed services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. Furthermore, there is no way for WHC to differentiate whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
It is critical to underscore that ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors are dependent on patient age and other risk factors that support screening. As a result, none of these cervical cancer screening-related data elements can be used to monitor adoption and adherence to screening guidelines or track progress towards Healthy People 2030 goals (i.e., increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines), as described in the Supporting Statement for the Title X FPAR 2.0. When extracting data to calculate measures, there is no way to qualify whether an appropriate screening interval was applied.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
FPAR 2.0 suggests that Title X service sites collect and report on five different data elements related to cardiovascular health: Systolic blood pressure, Diastolic blood pressure, Height, Weight, and Smoking status (detailed as ever smoker, ex‐smoker, smokes daily, occasional smoker, smoker, status unknown, heavy smoker, light smoker). Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
WHC believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0. BMI is not a useful indicator of health, especially for women of color, because it fails to account for differences in body composition, fitness levels, and nutritional differences. Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
WHC requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
The current FPAR 2.0 project stands to severely disrupt WHC’s operations during already uncertain times. WHC, like many Title X grantees, will have a harder time recruiting additional safety net providers to join its network, an ongoing effort since the 2019 Title X Rule took effect and WHC lost one subrecipient, a departure that resulted in approximately 800 fewer Title X patients served in 2020. WHC also is concerned of losing existing subrecipients and service sites that cannot absorb this data collection burden.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
We are striving to see more patients. While we agree that the Title X program needs a more contemporary data system for monitoring and improving program performance, such an endeavor cannot come at the expense of serving those in need of services, specifically patients who are low-income, uninsured, and under-insured. Such an effort also cannot come at the expense of providing Title X patients with the same standard of care as their counterparts who receive care in non-Title X settings, which is just what FPAR 2.0 - with burdensome and unnecessary data elements that are required for every visit – would do. Accordingly, WHC urges OPA to pause and re-evaluate FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection system, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While NFPRHA appreciates the need for a modern data system for monitoring and improving program performance, the current FPAR 2.0 project must be paused. The 23 additional elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. Accordingly, NFPRHA requests that OPA plan and initiate a different process for transitioning to a new data collection and reporting system with continued stakeholder involvement.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Under the best of circumstances, OPA’s proposal for FPAR 2.0 is flawed. Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077)	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
At this time – against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule2 – implementation of FPAR 2.0 simply is not feasible for Title X grantees and subrecipients. These organizations are working hard to rebuild and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
NFPRHA requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all Title X grantees and service sites are facing. Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, Title X grantees and subrecipients must upgrade existing information technology (IT) infrastructure.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
NFPRHA estimates that it will take 12-18 months to initiate encounter-level data collection and reporting through FPAR 2.0	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Implementing necessary system upgrades: To implement FPAR 2.0, grantees must implement IT system upgrades that involve building or modifying an existing data warehouse and setting up secure file transfer with subrecipients using secure file transfer protocol (SFTP). On the subrecipient level, organizations must engage in system upgrades that may involve adopting and implementing new electronic health record (EHR) or electronic data collection systems to report encounter-level data or customizing existing systems so the FPAR 2.0 data elements map to existing standardized value sets. Most grantees and subrecipients must manage vendor acquisition and procurement processes as part of this phase, a process that can be particularly slow in the public sector. Of note, 40 Title X service grants are administered by state and local health departments.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Data validation: Grantees must work with each of their subrecipients to electronically validate data. Data validation is an involved process that entails ensuring that all data are present and, from there, conducting quality assurance to ensure there are no incongruent or incomplete counts, duplicate data, incorrect formats, and null field values.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Training: After making all necessary system upgrades, grantees must train staff at their organizations and at the subrecipient level on how to collect new data elements. From there, to ensure full and accurate data collection when systems “go live,” grantees will conduct preliminary data collection, perform quality assurance of preliminary data collected, and offer technical assistance and retrain as needed.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
The limited availability of IT staff or vendors/external consultants to complete upgrades due to competing projects and existing engagements (e.g., developing vaccine appointment scheduling systems and registries, integrating telehealth platforms with EHRs, providing day-to-day IT support to remote staff) also will extend the standard timeline for such changes.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Current OPA timelines also assume a level of baseline technology at both the Title X grantee and subrecipient levels. However, many Title X grantees and subrecipients have not yet adopted EHR systems; as of 2016, 31% of Title X service sites had not adopted EHR systems. Instead, these organizations use paper forms and/or homegrown legacy systems (e.g., billing systems, Department of Social Services Medicaid portals) to collect FPAR data for aggregate submission. Those service sites without EHRs will not be able to begin reporting FPAR 2.0 data electronically on January 1, 2022, as EHR implementation typically takes 9 to 11 months, with three months for planning and six to eight months for implementation.4 Instead, if FPAR 2.0 goes into effect on that date, they will need to collect and perform manual data entry of FPAR 2.0’s 45 proposed data elements for every visit, and then determine how to deidentify line-item records so that they can be transmitted securely. This cumbersome process not only raises concerns about the effective use of Title X resources, but also about the security and confidentiality of clients’ sensitive health information.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
NFPRHA requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing encounter-level data collection and reporting through FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study5, was published in 2009 using data collected from Title X grantees about the cost and time burdens of implementing a new FPAR system that reports data aggregately (as opposed to encounter-level data reporting and collection). OPA has not collected more recent feedback from the Title X network regarding burden and costs associated with encounter-level data collection and the proposed new FPAR 2.0 data elements. The FPAR Burden Study estimated gross non-labor costs to be $163,300 (or $2,207 per respondent) and annualized labor costs to be $106,880 (or $1,444 per respondent).6 It is inappropriate for OPA to use data collected from the 2009 FPAR Burden Study to quantify costs for implementing the encounter-level data reporting system currently proposed, as these estimates relate to a completely different iteration of the proposed overhaul of FPAR that would be substantially less burdensome on grantees and subrecipients. Indeed, it was not until 2012 that OPA engaged an FPAR Expert Work Group consisting of Regional Program Consultants, grantee representatives, and other federal and federally funded stakeholders to assess the feasibility of revising the data elements and transitioning FPAR reporting to an enhanced encounter-level system. In 2014, OPA requested Office of Management and Budget (OMB) approval to begin assessing the feasibility of encounter-level data collection and the proposed new FPAR 2.0 data elements,8 but that assessment was not completed.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Another factor that has changed in the last decade is the cost of technology for use in health care. The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted in 2009, led to changes in the health IT industry that increased costs for these proposed changes. As part of the American Recovery and Reinvestment Act (ARRA), the HITECH Act allocated $19.2 billion to promote the adoption of use of health IT by providers who serve patients with Medicare and Medicaid. While HITECH Act funds supported some, but not all, Title X service sites to adopt and implement electronic health records (EHRs), the infusion of funds into the health IT industry gave rise to a multitude of EHR vendors and platforms and, in turn, challenges with interoperability (i.e., electronic sharing of data between systems). Health data exchange and interoperability solutions are available to streamline data exchange and electronic reporting, but this additional technology carries time (burden hours) and costs for customizations. In addition, HITECH funds were one-time investments, so funding to support upgrades and changing technology is not available. Consequently, there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems. Of note, though local and state health departments were eligible to receive HITECH Act funds and understood that IT investments were imperative, most lacked the necessary staff expertise, time, and resources to meet the timelines mandated by HITECH.9 Based on NFPRHA’s estimates, almost half (47%) of Title X service sites currently are operated by local and state health departments. Because many of these service sites did not benefit from HITECH funds and may continue to use paper forms or homegrown legacy systems, they lack the IT infrastructures needed to implement FPAR 2.0 in accordance with OPA’s project schedule. And, for the same reasons that many local and statement health departments could not meet the timelines mandated by HITECH, they also cannot implement FPAR 2.0 in accordance with OPA’s project schedule.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
In 2020, NFPRHA began conversations with various grantees and health information system subject matter experts about the burden and cost of implementing FPAR 2.0. Based on information collected, NFPRHA estimates that implementing FPAR 2.0 as proposed will amount to $65,000 in average one-time non-labor costs per grantee, or an average of $4,680,000 across all 72 service grantees.10 Spending will be on engaging EHR vendors or other external contractors to build or modify existing data warehouses and perform system upgrades, as well as purchasing or subscribing to a SFTP server. These cost estimates do not include ongoing expenses such as computer and software upgrades and purchased service costs.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Labor costs also will be high. In March 2021, 40 grantee organizations provided NFPRHA with estimates for the number of hours they will need to spend implementing FPAR 2.0 as currently planned. Based on this data, NFPRHA estimates grantee organizations each will spend 183 hours implementing FPAR 2.0. These estimates are based on the cost of working on tasks related to implementation, including selecting and/or creating a contract with a vendor, working with vendors to perform necessary system upgrades and map out FPAR 2.0’s data elements to existing standardized value sets, training health care providers and staff on how to collect new data elements, conducting preliminary data collection, running reports to ensure data mapping is correct, and performing quality assurance of preliminary data collected. Based on average (weighted) hourly wage estimates published in the Supporting Statement for the Title X FPAR 2.0 ($40.12), these burden hours will amount to $7,342 in one-time labor costs per grantee, or $528,621 across all 72 current grantees.11	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Another striking limitation of the 2009 Burden Study is its failure to include estimates for the burden that must be undertaken by the Title X network’s 1,060 subrecipients and 3,825 service sites.12 Based on information submitted by 36 grantees in March 2021, NFPRHA estimates that each subrecipient will spend an average of 85 hours implementing FPAR 2.0 as currently planned in 2021. Based on average (weighted) hourly wage estimates published in the Supporting Statement for the Title X FPAR 2.0 ($40.12), these burden hours will amount to $3,410 in one-time labor costs per subrecipient, or $3,614,812 across all 1,060 current subrecipients.13 Furthermore, NFPRHA estimates that current subrecipients will spend an average of $18,000 in one-time non-labor costs, primarily paid to EHR vendors and/or external contractors, to make changes to their EHRs or practice management systems (e.g., build new or update existing templates, code new data elements’ value sets). Across all 1,060 current subrecipients these one-time non-labor costs amount to $19,080,000. To reiterate, subrecipients will incur these capital costs during the same fiscal year(s) as the COVID-19 public health emergency – a time when resources have been redirected to emergency response and revenue has dwindled due to decreases in patient census. Based on the above estimates, the cost of implementing FPAR 2.0 as currently planned across the Title network is $27,903,433.15 NFPRHA can provide additional information to substantiate this estimate upon request.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
OPA is proposing this time commitment take place when grantees and subrecipients are continuing to respond to – and facing burnout from – the COVID-19 public health emergency. Costs for ongoing operations and maintenance are not included in these estimates. They also do not include the additional time it will take health care providers and staff at Title X service sites to document more than 20 additional data elements as part of every single Title X visit.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
NFPRHA believes the 23 additional elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. NFPRHA asks for additional opportunities for grantees and other stakeholders to provide feedback on what additional data elements are feasible to add to the current FPAR clinic visit record and would be most helpful for program management and quality improvement.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Management of the Title X program entails monitoring progress towards performance goals required by the 1993 Government Performance and Results Act (Pub. L. 103-62), which include: giving priority in the provision of family planning services to low-income individuals, reducing invasive cervical cancer through Pap testing, reducing infertility through chlamydia screening, and increasing program efficiency by monitoring the cost of care. However, with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
These data elements seem to map more to the elements in a research database than in a program monitoring tool, requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,” they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health.18 However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)].19 These sexual activity-related data fields also are not needed to monitor Title X grantees’ accountability to program goals. It is important to emphasize that patients accessing services in non-Title X settings would not be asked to provide responses to these personal, guideline-unconcordant questions at every visit, nor would their responses be reported at the encounter level to the federal government. When the federal government begins collecting research data for its benefit and requires those accessing services through the safety net to provide such information as a precursor to receive care, it exacerbates medical mistrust, potentially dissuading patients from accessing needed services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
New Data Element: Future Pregnancy Intention Reported Another example of a proposed data element that is inconsistent with current research on the provision of patient-centered contraceptive care is the FPAR 2.0 data element tracking patients’ intention to either become pregnant or prevent a pregnancy in the next year. Research suggests that many patients cannot articulate their pregnancy intentions over the next year; doing so is inconsistent with how they think about and approach their reproductive lives.20 21 Indeed, not all individuals overtly plan to have children or not have children, suggesting that asking about reproductive "intentions" or "plans" may be problematic.22 Asking patients this kind of a question at every visit, regardless of the reason for the visit, could compromise the patient-provider relationship by breaking rapport and shifting the visit away from what the patient wants. Reflecting current research that patients prefer to be asked about their service needs than about pregnancy intentions or desires23, NFPRHA recommends that FPAR 2.0 use a more patient-centered approach to measurement. An example of an alternative measure that assesses patients’ desire for contraceptive services is the Self-Identified Need for Contraception (SINC)24 question developed by the University of California, San Francisco (UCSF) Person-Centered Reproductive Health Program in consultation with Reproductive Justice advocates. Of note, UCSF has an award from OPA to develop a new electronic Clinical Quality Measures (eCQMs) of contraceptive provision using the SINC question to define the denominator. As such, use of the SINC question in FPAR 2.0 would be consistent with other initiatives underway at OPA. Use of this type of measure also would facilitate the removal of problematic data elements related to sexual activity, which have been included to identify whether a patient is perceived as “at risk” for pregnancy.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Additionally, the Patient-Centered Contraceptive Counseling (PCCC) Measure is not intended to be implemented within an EHR specification so it cannot be implemented within the FPAR 2.0 EHR specifications. OPA has plans to develop technical assistance to work with grantees to implement the PCCC when certain thresholds of utilization are met. SINC has been included in FPAR 2.0 as an optional data element because it has not yet been NQF endorsed. Because it has not yet been endorsed or not yet widely adopted by the field, OPA will implement it over time with grantee feedback and TA.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.25 Furthermore, there is no way for grantees and subrecipients to differentiate whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance. It is critical to underscore that ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors are dependent on patient age and other risk factors that support screening.26 As a result, none of these cervical cancer screening-related data elements can be used to monitor adoption and adherence to screening guidelines or track progress towards Healthy People 2030 goals (i.e., increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines), as described in the Supporting Statement for the Title X FPAR 2.0.27 28 Therefore, the time and resource investments that grantees and subrecipients must make to collect and report these additional data elements will produce data with little – if not no – value for monitoring and improving program performance.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
New Data Elements: Cardiovascular Risk Factors FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.25 Furthermore, there is no way for grantees and subrecipients to differentiate whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance. Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines. Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.29 NFPRHA believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information, and how it will be used, in the Supporting Statement for the Title X FPAR 2.0.30 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it fails to account for differences in body composition, fitness levels, and nutritional differences.31 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.32 Patients accessing health services in non-Title X settings typically are weighed (or asked to self-report their weight) only when clinically indicated. Title X patients should receive the same standard of care and should not be subject to weight stigmatization at every visit. Weight stigma invokes psychological stress and emerging research suggests that this stress can exacerbate poor physical health outcomes for obese individuals33, with the potential to perpetuate racial/ethnic and socioeconomic health disparities in overweight and obesity. It would be more appropriate to focus on measures of health that are scientifically valid and designed for diverse patient populations. Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for all patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, service sites should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Element: National Provider Identifier (NPI) NPI is yet another proposed data element in FPAR 2.0 that has little or no value to grantees and subrecipients. While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act- (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in 2019, 32% percent of all Title X family planning encounters were performed by other types of providers, including registered nurses, registered nurses with an expanded scope of practice, licensed practical nurses, health educators, and social workers.34 As such, many providers delivering Title X services do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
NFPRHA requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.35 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.36 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps grantees will be required to take. Despite a range of opinions about what qualifies as sensitive health information, it generally is considered to be information that carries with it unusually high risks in the event of disclosure. Several data elements within FPAR are sensitive in nature, as they relate to sexual behaviors and other deeply personal topics.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
OPA has historically interpreted 42 CFR Part 59 as precluding the collection of identifying information in connection with sensitive services. For example, in Supporting Statements for the Title X FPAR that were submitted to OMB (dated June 29, 2010 and October 15, 2010), OPA states in its “Justification for Sensitive Questions”: “Although the FPAR contains several data items of a sensitive nature (e.g., user income and insurance status, user race, type of contraceptive method used or adopted, STD tests performed, and Pap and HIV test results), individuals cannot be identified because federal regulation (42 CFR Part 59) requires that grantees report only aggregate user totals. The FPAR collects no individual identifiers. These sensitive data are required to monitor compliance with statutory requirements.”37 38 However, in the February 5, 2021 Supporting Statement for the Title X FPAR 2.0, OPA describes the need to collect encounter-level data of a sensitive nature, stating that the collection of such data “are required to monitor compliance with statutory requirements, program regulations and guidelines, performance reporting, and ongoing program management.”39 Given this shift in OPA’s justifications to OMB, OPA needs to provide clarification on the permissibility of submitting encounter-level data through FPAR 2.0.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
NFPRHA supports investments in Title X program infrastructure, including investment in a more contemporary data system for monitoring and improving program performance; however, such a venture cannot come at the expense of serving those in need of services, specifically patients who are low-income, uninsured, and under-insured. Such an effort also cannot come at the expense of providing Title X patients with the same standard of care as their counterparts who receive care in non-Title X settings, which is just what FPAR 2.0 - with burdensome and unnecessary data elements that are required for every visit – would do. Accordingly, NFPRHA urges OPA to pause and re-evaluate FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, Family Planning Annual Report, “(FPAR) 2.0,” proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
We write today with significant concerns about the proposed changes in this rule and the impact they will have on patients, providers and clinics in our state. These changes would jeopardize patient and provider relationships, interfere with evidence-based practice, and threaten patient confidentiality. A patient’s sexual and reproductive health are sensitive. The proposed FPAR 2.0 data elements risk the trust, confidentiality and privacy that’s essential in providing quality patient care, especially among the young people we see in our clinic. Patient-provider relationships will be harmed by inquiring about the invasive and unnecessary specifics in many of the proposed FPAR 2.0 data elements, which include details on a patient’s sexual activity, intention to become pregnant, sexually transmitted infection testing and more.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
The proposed data elements do not adhere to modern sexual and reproductive health clinical guidelines and have the potential to harm a provider’s ability to build and maintain trust with diverse Title X patient populations. These data elements are irrelevant to monitoring the Title X program for compliance and accountability to performance goals and will not ultimately improve the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Collection of this data would weaken clinics’ and providers’ ability to serve patients effectively with quality family planning services. Many of these encounters are short, especially telehealth visits, and collecting itemized data and additional personal information from patients would interfere with providing comprehensive contraceptive and/or preconception counseling during these appointments.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
The proposed FPAR 2.0 data elements would also burden providers as they would require significant changes to clinical workflow and complex changes to electronic health record systems. Many Title X providers already spend a considerable amount of time on data submission and reporting to other federal programs and providers. These proposed data elements will overburden providers with reporting requirements.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
It is unclear what the patient identifier will be under FPAR 2.0, but even if data is de-identified, there will still be sensitivity and patient trust concerns as this patient-level data will be shared with the federal government. Many of the proposed elements should not be collected at the federal or state level, and some could be considered as protected health information.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Under the best of circumstances, OPA’s proposal for FPAR 2.0 is flawed. Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077)	OPA appreciates comments expressing concern about the estimated burden of reporting FPAR 2.0 data. The department also acknowledges the need for grantees and subrecipients to examine changes in workflow, address challenges of interoperability across disparate EHR systems, and complete other activities related to mapping data, training staff, and preparing workflows and systems for encounter-level reporting. However, for the purpose of assessing burden, we are focused on the estimated time to collect and report the required data elements, not any capital investments needed for system development and enhancements. Additionally, OPA recognizes the burdens of preparatory activities and is providing supplemental funding and technical assistance (TA) to help address these burdens. OPA further believes that once implemented, a standards-based data collection adopted by EHR vendors and grantees should reduce reporting burden. Additionally, OPA is currently collecting input from a small sample of grantees to supplement the previous burden estimates and is reviewing industry-standard estimates of level of effort for similar collection and reporting activities.
it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While Essential Access appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused. At the same time, OPA must plan and initiate a new process for transitioning to a new data collection and reporting system with continued stakeholder involvement.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
At this time – against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule1 – implementation of FPAR 2.0 simply is not feasible. We are working hard to hold on, rebuild, and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Before the 2019 Title X Rule took effect, California’s statewide Title X provider network included 63 health centers collectively operating 366 service sites in 38 California counties. After the regulations were fully implemented, providers across the state were forced to make the difficult decision to exit the program and leave behind critical resources. As a result, the state’s Title X provider network was drastically reduced to 237 clinic sites in 20 counties and the number of patients served by the program in the state has been reduced by more than 80%.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
In addition, the COVID-19 pandemic has brought on its own challenges to all subrecipients across the network. These organizations have faced decreased patient numbers, Title X and IT staff being diverted to the COVID-19 response, budget shortfalls amidst the need to purchase PPE and provide vital COVID-19-related services, staff resigning or going on extended leave for personal or health-related reasons, implementation of telehealth services, and temporary health center closures. All of these additional burdens have challenged the network to provide low-income individuals with family planning and related preventive health services.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Any attempt to implement FPAR 2.0 in accordance with current timelines will severely disrupt and undermine their ability to continue to respond to the pandemic and our ability to re-build our network once the 2019 Title X Rule is reversed.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Essential Access requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study, was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that make the data collected no longer relevant.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
OPA has not collated recent feedback from the Title X network regarding costs associated with encounter-level data collection and the proposed new FPAR 2.0 data elements. Estimates in the FPAR Burden Study, where gross non-labor costs were estimated to be $163,300 (or $2,207 per respondent) and annualized labor costs were estimated at $106,880 (or $1,444 per respondent)3, are based on the cost and time burdens of implementing a new FPAR system that reports data aggregately (as opposed to encounter-level data reporting and collection). It is inappropriate for OPA to use data collected from the 2009 FPAR Burden Study to quantify costs for implementing the encounter-level data reporting system currently proposed, as these estimates relate to a completely different iteration of the proposed overhaul of FPAR that would have been substantially less burdensome on grantees and subrecipients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating that each grantee-subrecipient dyad invest in upgrades to electronic systems and establishing interoperability between their respective systems. In addition, each sub-recipient utilizes its electronic health record system differently, including in how and where in the system data elements are collected, resulting in each organization needing to develop their own custom reporting solution.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
For Essential Access as a grantee, we estimate that implementing FPAR 2.0 will amount to approximately $225,000 in one-time labor costs. This estimate is based on the cost of four staff persons working a combined 2400 hours on tasks related to implementation, including implementing an upgraded data management system that can accommodate the additional data, updating and testing subrecipient configurations in the new data system, updating a secondary aggregate data system to accommodate the additional data elements, training subrecipient staff on how to collect new data elements and how to use the new system, working with subrecipient staff and their third party vendors to make updates to EHR systems including new fields and report modifications, and performing quality assurance of preliminary data collected.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
We also estimate that each of our subrecipients, whose number we expect to increase to approximately 60 organizations, will spend an average of 80 hours implementing FPAR 2.0, plus 4 hours of training per service site at an estimated 300 services sites, for an estimated total of 6000 hours in one-time labor costs of approximately $385,000 across this single Title X grantee network. Again, OPA is proposing this time commitment take place when we are continuing to respond to – and facing burnout from – the COVID-19 public health emergency. Costs for ongoing operations and maintenance are not included in these estimates. They also do not include the additional time it will take health care providers and staff at Title X service sites to document more than 20 additional data elements as part of every single Title X visit. Essential Access estimates that implementing FPAR 2.0 as proposed at the grantee level will amount to $480,000 in one-time non-labor costs to purchase the upgraded data management system. Furthermore, we estimate that each of our estimated 60 subrecipients will outlay an average of $2000 in non-labor costs to implement FPAR 2.0, for an estimated total of $120,000 in non-labor costs across this single Title X grantee network. This comes during the same fiscal year(s) as the COVID-19 public health emergency when resources have been redirected to emergency response and revenue has dwindled due to decreases in patient census. These cost estimates do not include ongoing expenses such as computer and software upgrades.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The 23 additional data elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. We ask for additional opportunities to provide feedback on what additional data elements are feasible to add to the current FPAR clinic visit record and would be most helpful to us for program management and quality improvement.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Management of the Title X program entails monitoring progress towards performance goals required by the 1993 Government Performance and Results Act (Pub. L. 103-62), which include: giving priority in the provision of family planning services to low-income individuals, reducing invasive cervical cancer through Pap testing, reducing infertility through chlamydia screening, and increasing program efficiency by monitoring the cost of care. However, with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
FPAR 2.0 represents an effort that has no intention of being minimally burdensome. It corresponds to the deliberate transition of FPAR from a program monitoring tool to a research dataset, requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Furthermore, some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors.4 While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy,”5 they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health.6 However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)].7 These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals. It is important to emphasize that patients accessing services in non-Title X settings would not be asked to provide responses to these personal, guideline-unconcordant questions at every visit, nor would their responses be reported at the encounter level to the federal government. When the federal government begins collecting research data for its benefit and requires those accessing services through the safety net to provide such information as a precursor to receive care, it exacerbates medical mistrust, potentially dissuading patients from coming to us for needed services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
Data Elements: Cervical Cancer Screening FPAR 2.0 requires that Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, All Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.8 Furthermore, there is no way to differentiate in the FPAR data whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance. It is critical to underscore that ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors are dependent on patient age and other risk factors that support screening.9 As a result, none of these cervical cancer screening-related data elements can be used to monitor adoption and adherence to screening guidelines or track progress towards Healthy People 2030 goals (i.e., increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines), as described in the Supporting Statement for the Title X FPAR 2.0.10 11 When extracting data to calculate measures, there is no way to qualify whether an appropriate screening interval was applied.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
New Data Elements: Cardiovascular Risk Factors FPAR 2.0 suggests that Title X service sites collect and report on five different data elements related to cardiovascular health: Systolic blood pressure, Diastolic blood pressure, Height, Weight, and Smoking status. Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines. Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force. The collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0. Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it fails to account for differences in body composition, fitness levels, and nutritional differences.14 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.15 Patients accessing health services in non-Title X settings are not weighed at every visit unless clinically indicated. Title X patients should receive the same standard of care and should not be subject to weight stigmatization at every visit. Weight stigma invokes psychological stress and emerging research suggests that this stress can exacerbate poor physical health outcomes for obese individuals16, with the potential to perpetuate racial/ethnic and socioeconomic health disparities in overweight and obesity. It is time to move away from this measure and focus on measures of health that are scientifically valid and designed for diverse patient populations. Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for additional patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Element: National Provider Identifier (NPI) While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act- (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in 2019, 7.4% of all Title X family planning encounters in the Essential Access network were performed by other services providers, including registered nurses, licensed practical nurses, health educators, and social workers. As such, many of our providers delivering Title X services do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
CONFIDENTIALITY OF SENSITIVE PERSONAL HEALTH INFORMATION Essential Access requests clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.17 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.18 Despite a range of opinions about what qualifies as sensitive health information, it generally is considered to be information that carries with it unusually high risks in the event of disclosure. Several data elements within FPAR are sensitive in nature, as they relate to sexual behaviors and other deeply personal topics. While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it is imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Essential Access requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all Title X grantees and service sites currently are facing. Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, Essential Access would need to upgrade to its information technology (IT) infrastructure, as would its projected 60 subrecipients. However, as of April 12, 2021, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response options to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently, we estimate it will take approximately 12 months to provide technical assistance to 60 subrecipients to add new fields to their systems, and another 12 months of technical assistance to help subrecipients update their data reports. In addition, concurrently it will take us an estimated 18 months to make all necessary upgrades to our data system and agency configurations inside that system. Extending this timeline is the limited availability of subrecipient IT staff to complete upgrades due to competing projects such as telehealth implementation, and because of understaffing due to the pandemic. After making system upgrades, Essential Access and its subrecipients (which will operate approximately 300 service sites) will require 4 hours per service site to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed, for a total of 1200 hours. Initiating upgrades before final specifications are available would be wasteful, as inconsistencies would require revisions that would carry additional costs and burden hours spent.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The current FPAR 2.0 project stands to severely disrupt operations during already uncertain times. Essential Access, like many Title X grantees, will have a harder time recruiting additional safety net providers to join its network, an ongoing effort since the 2019 Title X Rule took effect and Essential Access lost 16 subrecipients, departures that resulted in 80% fewer Title X patients served in 2020. We are also concerned about losing existing subrecipients and service sites that cannot absorb this data collection burden.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
We are striving to see more patients after unprecedented declines in patient census. While we agree that the Title X program needs a more contemporary data system for monitoring and improving program performance, such an endeavor cannot come at the expense of serving those in need of services, specifically patients who are low-income, uninsured, and under-insured. Such an effort also cannot come at the expense of Title X patients receiving the same standard of care as their counterparts who receive care in non-Title X settings, which is just what FPAR 2.0 - with burdensome and unnecessary data elements that are required for every visit – would do. Accordingly, Essential Access urges OPA to pause and re-evaluate FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, Family Planning Annual Report, “(FPAR) 2.0,” proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
We write today with significant concerns about the proposed changes in this rule and the impact they will have on patients, providers and clinics in our state. These changes would jeopardize patient and provider relationships, interfere with evidence-based practice, and threaten patient confidentiality. A patient’s sexual and reproductive health are sensitive. The proposed FPAR 2.0 data elements risk the trust, confidentiality and privacy that’s essential in providing quality patient care, especially among young people and individuals who are undocumented.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Patient-provider relationships will be harmed by inquiring about the invasive and unnecessary specifics in many of the proposed FPAR 2.0 data elements, which include details on a patient’s sexual activity, intention to become pregnant, sexually transmitted infection testing and more. The proposed data elements do not adhere to modern sexual and reproductive health clinical guidelines and have the potential to harm a provider’s ability to build and maintain trust with diverse Title X patient populations. These data elements are irrelevant to monitoring the Title X program for compliance and accountability to performance goals and will not ultimately improve the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Collection of this data would weaken clinics’ and providers’ ability to serve patients effectively with quality family planning services. Many of these encounters are short, especially telehealth visits, and collecting itemized data and additional personal information from patients would interfere with providing comprehensive contraceptive and/or preconception counseling during these appointments.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
It is unclear what the patient identifier will be under FPAR 2.0, but even if data is de-identified, there will still be sensitivity and patient trust concerns as this patient-level data will be shared with the federal government. Many of the proposed elements should not be collected at the federal or state level, and some could be considered as protected health information.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
The requirements are onerous and will discourage small clinics from continuing to participate in Title X.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The requirements will substantially alter the patient-provider interaction and foster distrust among patients due to the many, invasive questions required.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Marginalized populations most in need of the reproductive healthcare only available to them through Title X will be the most affected.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To addsress implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an addsitional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
As a direct result in the change of the Title X rules in 2019 over 55% of the Family Planning Council of Iowa’s (FPCI’s) network of clinics was forced to withdraw from the program. FPCI has spent roughly the last 18 months desperately trying to recruit and onboard new clinics and providers to serve more low-income patients while managing through a global pandemic, COVID-19.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
FPCI had begun preparations to implement a centralized data system but the project was paused for over 12 months due to COVID-19 because many of the agencies we partner with to provide Title X services are Federally Qualified Health Centers and small, localized public health departments where IT staff were diverted to adjust systems at these facilities to manage disaster response. The pandemic is not over and any attempt to implement FPAR 2.0 in accordance with current timelines will severely disrupt and undermine our ability to respond to these top priorities of stabilizing and growing our network.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, FPCI would need to upgrade to its information technology (IT) infrastructure, as would its 13 subrecipients. However, as of 4/12/21, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Current OPA timelines also assume a level of baseline technology at both the Title X grantee and subrecipient levels which FPCI does not have. as previously mentioned, we use paper systems to collect FPAR data for aggregate submission. As data system and EHR enhancements typically takes 9 to 11 months, with three months for planning and six to eight months for implementation. Instead, if FPAR 2.0 goes into effect on that date, we will need to collect and perform manual data entry of FPAR 2.0’s 45 proposed data elements for every visit, and then determine how to deidentify line-item records so that they can be transmitted securely. This cumbersome process not only raises concerns about the effective use of Title X resources, but also about the security and confidentiality of clients’ sensitive health information.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome. It corresponds to the deliberate transition of FPAR from a program monitoring tool to a research dataset, requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It is important to emphasize that patients accessing services in non-Title X settings would not be asked to provide responses to these personal, guideline-unconcordant questions at every visit, nor would their responses be reported at the encounter level to the federal government. When the federal government begins collecting research data for its benefit and requires those accessing services through the safety net to provide such information as a precursor to receive care, it exacerbates medical mistrust, potentially dissuading patients from coming to us for needed services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and addss addssitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
FPCI believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0. Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences. Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.13 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
The new FPAR data collection system is likely to reduce providers’ willingness to participate in Title X, which would have dire consequences for family planning provision in the US	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To addsress implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an addsitional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Marginalized populations would likely hesitate to seek services from Title X providers because there would be risks to patient privacy in the new system	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
The data provided by the new system are likely to be biased because of difficulties for smaller Title X providers with providing the requested data.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014).
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To addsress implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an addsitional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
PHS has experienced several challenges since 2019, including the loss of Title X, which comprised one-third of PHS’ SRH Centers’ budget. This funding loss resulted in the departure of key clinical staff and required the Centers to drastically reduce their operating hours, which limited our ability to see patients for several months. This loss, combined with the onset of COVID-19, has been devastating for PHS’ SRH Centers. From 2019 to 2020, the Centers’ patient census decreased by 43%. Already reeling from staffing and operational challenges related to relinquishing Title X, clinical and operations staff were diverted to responding to COVID-19 and the rapid implementation of telemedicine services.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, PHS would need to upgrade to its information technology (IT) infrastructure, as would our five former subrecipients. However, as of April 12, 2021, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently, we estimate it will take 3 months to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0. PHS would need to create new clinical workflows to align with the new FPAR 2.0 framework and modify existing EMR systems to capture new data elements. Staff would need to be trained on new workflows and where to code the new fields. IT technical staff and EMR vendors would also need to work collaboratively to build out a new reporting framework that would allow for the submission and validation of these new data elements.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
After making system upgrades, PHS will require 3 months to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study2, was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the data collected no longer being relevant.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Furthermore, some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors. While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,” they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually (unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)).7 These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
PHS believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0. Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences. Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for additional patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act- (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in 2019, 15 percent of all Title X family planning encounters at PHS’ SRH Centers were performed by other services providers, including registered nurses, licensed practical nurses, health educators, and social workers. As such, many of our providers delivering Title X services do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0. While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels;	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
The current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is not feasible. As of April 1, 2021, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently, we estimate it will take six months at the IDPH level, along with six to 12 months at the SR level to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0. This includes steps to upgrade the current Title X data system at IDPH, including processes related to SRs modifying their current electronic health record (EHR) or electronic data collection system to report specific data elements and customizing the existing IDPH data system so FPAR 2.0 data elements map to existing standardized value sets, and data validation efforts.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
After making system upgrades, IDPH and its SRs (which operate 19 service sites) will require three months to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
With the addition of 23 new data elements, many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards can be burdensome	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors. While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,” they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.04 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Despite a range of opinions about what qualifies as sensitive health information, it generally is considered to be information that carries with it unusually high risks in the event of disclosure. Several data elements within FPAR are sensitive in nature, as they relate to sexual behaviors and other deeply personal topics.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
many electronic health record (EHR) systems continue to lack data elements that are part of both FPAR 1.0 and FPAR 2.0 and it takes a substantial amount of staff time and technical assistance to build out those missing data elements. In particular, the lack of standard fields for pregnancy intention screening, contraceptive counseling, and the contraceptive method a patient is using as of the end of their visit have presented serious barriers to Upstream’s ability to do our work, and also likely presents barriers to the implementation of FPAR 2.0. Needs assessments should be conducted to ensure that the data elements are placed in EHR templates that fit the contraceptive care workflow at the particular agency. The Title X network will need technical support and resources to recommend workflow options within different EHR systems. We would welcome OPA’s advocacy with government offices like ONC and with EHR vendors around including family planning data elements to ensure that contraceptive care and other aspects of reproductive healthcare are appropriately standardized within these new systems.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
We also recommend limiting the number of data elements that must be newly incorporated into grantee EHR systems for reporting purposes. While there is utility in having three measures of sexual activity for research purposes, it is likely too burdensome to build out and to require clinicians to provide that level of documentation. Likewise, it seems that the two “reason for no contraceptive method” data elements are redundant because some of the response options will not change from the beginning to end of an encounter (i.e., sterility status).	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
In our work with health centers, we have found that requiring some data be collected every 12 months (instead of every visit) is more reasonable and is aligned with best practice. Will the FPAR 2.0 data system be able to do patient matching (at the health facility level) to see whether a patient was screened for pregnancy intention, cervical cancer, CT/GC, and syphilis according to clinical guidelines?	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To addsress implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an addsitional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
At this time—against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule—implementation of FPAR 2.0 simply is not feasible. We are working hard to hold on, rebuild, and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Every Body Texas has experienced several challenges since 2019. Every Body Texas moved quickly at the start of the 2020-2021 budget period to support its subrecipients in responding to the COVID-19 pandemic. The impacts of COVID-19 on Every Body Texas’s Title X Project are not unique. Like other safety net healthcare providers, sub-recipients have experienced temporary closures and reduced availability of in-person services—and have reported serving fewer clients, even as they worked tirelessly to maintain access to Title X services by incorporating no-contact methods, including teleservices. Most pressing for sub-recipients is the reality that reduced client volume has translated into reduced revenue. Over the last decade, sub-recipients have repeatedly navigated state-level funding and policy changes that threatened the sustainability of the family planning safety net. COVID-19 now presents another threat to critical funding. Sub-recipients are concerned that women’s health funding appropriated by the Texas Legislature and administered by the Texas Health and Human Services Commission (HHSC) will not adequately address the increased rates of uninsured and unemployed Texans seeking safety net healthcare services. Because Every Body Texas’s sub-recipients rely on HHSC’s women’s health funding to support their overall family planning projects, depending upon the severity of the funding impacts, there could be adverse impacts on Every Body Texas’s Title X Project—including but not limited to reduced client volume, reduced program income, and service site closures.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, the data warehouse for Every Body Texas, Ahlers & Associates, has estimated that it will need 520 hours to upgrade its information technology (IT) infrastructure.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Twenty of Every Body Texas’s 37 subrecipients that do not use Ahlers & Associates software or web-based applications to enter and transmit Title X data would have to add fields to their EMRs for the new data elements and update extraction methods and tools—in addition to conducting all testing and validation for these changes. All 37 subrecipients would require training and operational changes to ensure the new data elements are populated consistently. However, at present, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows. These technical unknowns on the OPA side, coupled with the diversity of our sub-recipients in terms of size and IT capacity, complicate time burden estimates for FPAR 2.0 implementation. With that in mind, and assuming that funding and staff for these new activities is available, we estimate it will take at least 18 months to coordinate our efforts with our data warehouse and subrecipients to implement and test technologies, train staff and conduct basic monitoring.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Every Body Texas requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. OPA has not collated recent feedback from the Title X network regarding costs associated with encounter-level data collection and the proposed new FPAR 2.0 data elements. Every Body Texas estimates that implementing FPAR 2.0 as proposed at the grantee-level will amount to $82,000 in one-time non-labor costs. This estimate is based on quotes received from existing vendors, including Ahlers & Associates.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Every Body Texas believes the 23 additional elements go beyond what is necessary for quality improvement and what is required by statutory requirements, regulations, and operational guidance. We ask for additional opportunities to provide feedback on what additional data elements are feasible to add to the current FPAR clinic visit record and would be most helpful to us for program management and quality improvement. with the addition of 23 new data elements—many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals—FPAR 2.0 represents an effort that has no intention of being minimally burdensome.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Furthermore, some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors. While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,” they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]. These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
Linking test results to test encounters is already a challenge for FPAR 1.0 data elements for pap smears/abnormal results and HIV tests/HIV+ results due to the segregation of data collection systems for most of our sub-recipients. While connecting tests to results is a worthwhile endeavor, the accelerated FPAR 2.0 timeline may lead to short-term solutions that serve Title X reporting only, as opposed to care improvements.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Every Body Texas believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0. Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences. Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for additional patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act- (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in 2019, 43% percent of all Title X family planning encounters in Every Body Texas’ network were performed by other services providers, including registered nurses, licensed practical nurses, health educators, and social workers. As such, many of our providers delivering Title X services do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0. While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
“FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit). While the NYSDOH appreciates that there may be a need for a more robust data system for monitoring and improving program performance, the NYSDOH is concerned that implementation of the FPAR 2.0 data collection and reporting system as defined is not feasible and must be paused.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To addsress implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an addsitional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0. While encounter-level data will be partially de-identified, OPA has not released specifications for how the patient identifier data element alone, and more particularly in combination with the National Provider ID (NPI), and full birth and visit dates, will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the Health Information Portability and Accountability Act- (HIPAA) Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently face, OPA should engage with the network to seek stakeholder feedback on the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
OPA has proposed that Title X service sites report the following three data fields for patients at every visit: ever had sex, sex in the last 3 months, and sex in the last year. In addition to the forementioned extreme sensitivity of this information, asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)].5 These sexual activity-related data fields also are not needed to monitor Title X grantee and subrecipient accountability to program goals.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
FPAR 2.0 suggests that Title X service sites collect and report on five different data elements related to cardiovascular health: systolic blood pressure, diastolic blood pressure, height, weight, and smoking status (detailed as ever smoker, ex‐smoker, daily smoker, occasional smoker, smoker, status unknown, heavy smoker, light smoker). The NYSDOH believes there is no logical rationale to record and report these data; there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
FPAR 2.0 further suggests that Title X service sites collect and report on a number of different data elements related to STI screening at each client visit, including screening at current visit and multiple results for Chlamydia, gonorrhea, and syphilis, as well testing at current visit, and rapid and supplemental results for HIV. Results, such as those for gonorrhea, may include as many as twenty different selections. The NYSDOH believes there is no logical rationale to record and report these data at every visit and report them in such detail. Capturing such detailed information in its existing status would be excessively burdensome and would require significant adjustment as laboratory testing technology evolves over time. Accordingly, we feel strongly that we should not be required to document and report these measurements for every visit.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. The data collection should not drive clinical care. Information should only be collected if it is part of the clinical encounter. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit HIPAA covered data or those who provide services “incidental to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in 2019, 6.4 percent of all encounters in the NYSDOH FPP were performed by other services providers, including registered nurses, licensed practical nurses, health educators, and social workers. As such, many of our providers do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
The implementation of FPAR 2.0 would have burdensome economic consequences both for the NYSDOH and for the agencies participating in the FPP. As noted above, NYS contracts with Ahlers and Associates to manage its centralized data system. Compliance with FPAR 2.0 reporting requirements would necessitate an extensive overhaul of the current system’s complex information technology infrastructure, which would incur substantial expense at a time when NYS’s budget is already overburdened. In the absence of complete specifications, it is difficult to accurately estimate the additional revenue required, but based on the information at hand, we estimate a cost of at least $250,000 but it could cost more.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
With 23 additional elements, and their myriad selection options, we anticipate that electronic health record (EHR) vendors might impose charges that will run well into the tens of thousands of dollars per agency during a time when resources are already severely stretched. With upwards of 40 agencies in the FPP, we estimate that this would total as much as $500,000, if not more. While the added cost would be burdensome in general, it would be particularly onerous for the small single-clinic and rural organizations, but also for the larger urban organizations that have struggled to maintain access and service during the COVID-19 crisis. Further, neither of these costs includes the inestimable additional expense required for NYSDOH FPP staff and agencies’ and clinics’ health care providers and staff to allot and coordinate their time and efforts on training and implementing the FPAR 2.0 changes.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The implementation timeline for FPAR 2.0 to begin on January 1, 2022 is not feasible. OPA has yet to release final specifications for collecting and reporting FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Title X safety net providers and the NYSDOH have experienced several challenges since 2019. The impact of COVID-19 has been particularly severe in New York State, resulting in closure of a number of the FPP clinics, both temporarily and permanently; implementing and diverting care to telehealth visits; and maintaining management of the program under the strain of staff redeployed to pandemic response service. Any attempt to implement FPAR 2.0 in accordance with current timelines would severely disrupt and undermine our ability to respond to these top priorities.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077); it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Encounter level data collection will allow for richer and more detailed analysis. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014) and is the first time OPA is collecting elements related to these measures. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is further offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. It does not include implementation burden. To addsress implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an addsitional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
At this time – against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule – implementation of FPAR 2.0 simply is not feasible. We are working hard to hold on, rebuild, and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, MFHC would need to upgrade to its information technology (IT) infrastructure, as would its 15 subrecipients. However, as of April 12, 2021 OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. I	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently, we estimate it will take 18-24 months to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0. This includes upgrades to MFHC’s centralized database, customizing reporting and mapping, working with 8 different EHR vendors on integration of new data elements, mapping, and reporting, data validation and testing, etc. After making system upgrades, MFHC and its subrecipients (which operate 63 service sites) will require 6-12 months to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed. Initiating upgrades before final specifications are available would be wasteful, as inconsistencies would require revisions that would carry additional costs and burden hours spent.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study2, was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the data collected no longer being relevant. Firstly, OPA has not collated recent feedback from the Title X network regarding costs associated with encounter-level data collection and the proposed new FPAR 2.0 data elements.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Secondly, due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems. In MFHC’s Title X network, there are 15 subrecipients using 8 EHR platforms.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
we estimate that implementing FPAR 2.0 will amount to $44,000 in one-time labor costs. This estimate is based on the cost of 5 staff persons working a combined 440 hours on tasks related to implementation, including selecting and/or creating a contract with a vendor, working (with vendors) to perform necessary system upgrades and map out FPAR 2.0’s data elements to existing standardized value sets, training health care providers and staff on how to collect new data elements, conducting preliminary data collection, running reports to ensure data mapping is correct, and performing quality assurance of preliminary data collected. We also estimate that each of our 15 subrecipients will spend an average of 40 hours implementing FPAR 2.0, for an estimated total of $60,000 in one-time labor costs across this single Title X grantee network. Again, OPA is proposing this time commitment take place when we are continuing to respond to – and facing burnout from – the COVID-19 public health emergency. Costs for ongoing operations and maintenance are not included in these estimates. They also do not include the additional time it will take health care providers and staff at Title X service sites to document more than 20 additional data elements as part of every single Title X visit.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome. These data elements seem to map more to the elements in a research database than in a program monitoring tool, requiring Title X service sites to collect excessive information from patients at every single visit, even though such information is not necessitated by clinical practice guidelines or other evidence-based standards.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
some proposed data elements pertain to services that are outside of the core family planning services in the Recommendations for Providing Quality Family Planning Services (QFP), including elements related to cardiovascular disease risk factors.4 While, as OPA has affirmed, these “related preventive health services… are appropriate to deliver in the context of a family planning visit even though they do not contribute directly to achieving or preventing pregnancy include screening for breast and cervical cancer,”5 they certainly should not be monitored at the encounter level to monitor accountability to program goals. We request additional justification for collecting these new data elements beyond the rationale provided by the Healthy People 2030 health objectives.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)].7 These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements.
Another example of a proposed data element that is inconsistent with current research on the provision of patient-centered contraceptive care is the FPAR 2.0 data element tracking patients’ intention to either become pregnant or prevent a pregnancy in the next year. Research suggests that many patients cannot articulate their pregnancy intentions over the next year; doing so is inconsistent with how they think about and approach their reproductive lives.8 9 This is particularly true for low-income populations.10 Indeed, not all individuals overtly plan to have children or not have children, suggesting that asking about reproductive "intentions" or "plans" may be problematic.11 Asking patients this kind of a question at every visit, regardless of the reason for the visit, could compromise the patient-provider relationship by breaking rapport and shifting the visit away from what the patient wants	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
MFHC believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.19 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.20 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.21	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Screening for cardiovascular risk factors is indicated to support contraceptive decision-making (i.e., to ensure a patient does not have contraindications to combined oral contraceptives and other hormonal contraception) and pre-pregnancy health. While it may be desirable to capture these measures for additional patients, there is no explicit expectation or requirement for Title X providers to obtain information beyond that which is clinically necessary. Accordingly, we should not be required to document and report these measurements for every visit.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds addsitional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.24 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore, OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
AccessMatters is deeply concerned about OPA’s proposal for FPAR 2.0. At this time – against the backdrop of a year-long public health emergency that resulted in an unprecedented drop in patient census and following a 46% decline in the network’s capacity nationwide after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule1 – implementation of FPAR 2.0 simply is not feasible. We are working hard to hold on, rebuild, and continue providing critical services to patients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Title X providers in our network have reported to us that they have experienced significant impact as a result of the COVID-19 pandemic. Specifically, they described considerable challenges around logistical changes (e.g., managing waiting room limits, implementing telehealth services), staffing (e.g., staff medical leave, staff being shifted to other teams to cover COVID-19 needs, increased turnover), and increased patient need (e.g., patients experiencing additional burden due to COVID-19, patients with more severe conditions due to delaying medical care during COVID-19). Despite COVID-19 vaccination efforts currently underway, COVID-19 cases continue to rise in our region and state, and the impact on our health care provider network continues with its full impact still unknown. Any attempt to implement FPAR 2.0 in accordance with planned timelines will severely disrupt and undermine our ability to respond to these top priorities.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
AccessMatters requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all Title X grantees and service sites currently face. The current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows. Currently, we estimate it will take 18 months to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Despite discussions of FPAR 2.0 dating back several years, as of April 12, 2021, OPA has still not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Current OPA timelines also assume a level of baseline technology at both the Title X grantee and subrecipient levels. However, five of our subrecipients still use paper forms to collect FPAR data and an additional six use legacy systems that will need to be redeveloped for FPAR 2.0. If FPAR 2.0 goes into effect on January 1, 2022, these sites will need to collect and perform manual data entry of FPAR 2.0’s 45 proposed data elements for every visit. This cumbersome process raises significant concerns about the effective use of Title X resources and the possibility of subrecipients opting to leave AccessMatters’ Network and the Title X program, which has occurred in previous years due to the burden of data entry.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
AccessMatters requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study2, was published in 2009 using data collected from Title X grantees more than twelve years ago.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems. In AccessMatters’ Title X Network there are 18 subrecipients using at least seven different EHR platforms. AccessMatters estimates that implementing FPAR 2.0 will exceed $1 million in one-time labor and non-labor costs combined for AccessMatters’ Title X Network. This estimate is based on the cost of an internal team at AccessMatters of five staff persons working at least 200 hours to get systems and processes ready for implementation by January 2022. It is important to note that our estimate is an underrepresentation of total cost to our Network, as these cost estimates do not include (1) ongoing expenses such as ongoing operations and maintenance in addition to computer and software upgrades and purchased service costs, or (2) the additional time it will take health care providers and staff at Title X service sites to document more than 20 additional data elements as part of every single Title X visit.	OPA has engaged grantees and EHR vendors in recent years to provide technical specifications and provide uniform guidance for collecting, formatting, and transmitting data. Earlier this year, OPA began information- and requirements-gathering meetings with grantees from each Department of Health and Human Services region to identify anticipated reporting challenges and approaches for minimizing reporting burden. OPA is also currently establishing outreach to EHR vendors to discuss opportunities to enhance implementation guides, options for file formats, and other guidance for IT representatives from EHR vendors and grantee organizations. Additionally, OPA will provide flexible options for acceptable file formats, including specifications for submitting flat files (that is, files that do not require EHR vendor technology).
Management of the Title X program entails monitoring progress towards performance goals required by the 1993 Government Performance and Results Act (Pub. L. 103-62), which include: giving priority in the provision of family planning services to low-income individuals, reducing invasive cervical cancer through Pap testing, reducing infertility through chlamydia screening, and increasing program efficiency by monitoring the cost of care. However, with the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
AccessMatters also has concerns about the invasive nature of the data collection and the questions these additional data sets will require providers to ask in a clinical setting. Healthcare providers need training in trauma-informed care and motivational interviewing to implement best practices around asking these more detailed questions of patients. As a grantee with a nationally-recognized training team that has experience providing healthcare providers with training and professional development around motivational interviewing and delivering trauma-informed care, AccessMatters recommends that OPA outline a detailed plan to position providers as best as possible to deliver trauma-informed, comprehensive counseling and care. This is a critical element that must be addressed before implementation given the sensitive nature of the data elements required by FPAR 2.0.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
AccessMatters also understands that the sensitive nature of additional data elements could be of great concern to some patients. This may lead to patients electing not to receive services through the Title X program because they have concerns about the amount and type of sensitive information being collected and do not want their information shared with the federal government.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
AccessMatters also strongly encourages OPA to consider adjustments to how demographic data are currently collected in FPAR and preparing and disseminating guidance to providers about how they can collect current required demographic data elements using a trauma-informed approach. Specifically, AccessMatters encourages OPA to adjust the options for data collection around gender identity.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Please see the attachment AccessMatters’ Standard Demographic Language for additional detail and recommendations on collecting demographic data, including sex assigned at birth. Pages 14 - 20.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health. However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X providers inquire about oral, vaginal, and anal intercourse and complete the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is intrusive, burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]. These sexual activity-related data fields also are not needed to monitor our Title X Network’s accountability to program goals.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted including the referenced three data elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval, and there is no national benchmark pertaining to the rate of tests that should come back as positive.8 Furthermore, there is no way for AccessMatters to differentiate whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance. It is critical to underscore that ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors are dependent on patient age and other risk factors that support screening.9 As a result, none of these cervical cancer screening-related data elements can be used to monitor adoption and adherence to screening guidelines or track progress towards Healthy People 2030 goals (i.e., “increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines”), as described in the Supporting Statement for the Title X FPAR 2.0.10 11 When extracting data to calculate measures, there is no way to qualify whether an appropriate screening interval was applied.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
New Data Elements: Cardiovascular Risk Factors FPAR 2.0 suggests that Title X service sites collect and report on five different data elements related to cardiovascular health: Systolic blood pressure, Diastolic blood pressure, Height, Weight, and Smoking status (detailed as ever smoker, ex‐smoker, smokes daily, occasional smoker, smoker, status unknown, heavy smoker, light smoker). Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Smoking status: Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.12	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Data Elements: Height, Weight, BMI AccessMatters believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.13 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.14 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shaming, body size stigma, and weight discrimination	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
New Data Element: National Provider Identifier (NPI) While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain a NPI number. In 2019, 24 percent of all Title X family planning encounters in AccessMatters’ Network were performed by other service providers, including registered nurses, licensed practical nurses, health educators, and social workers. As such, many of our providers delivering Title X services do not have an individual NPI number to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
Confidentiality of Sensitive Personal Health Information AccessMatters requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, those services are grounded in medical and ethical standards, and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services. Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.18 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently face, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Protecting Personally Identifiable Information of Family Planning Users Encounter-level data collected by Title X Grantees and reported to the Office of Population Affairs (OPA) should minimize collecting Personal Identifiable Information (PII). Currently, the Family Planning Annual Report (FPAR) collects demographic information including family planning user age, sex, race, ethnicity. Requiring grantees to collect and report family planning user demographics such as date of birth or zip code of residence could compromise patient confidentiality and grantees’ ability to comply with OPA reporting requirements. If OPA requires encounter-level data that could compromise patient confidentiality, OPA needs to demonstrate the necessity of collecting such information.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Sub Recipient Compliance The DHS Title X subrecipients have expressed concern in changes to reporting family planning user demographics, such as date of birth and zip code, collected by the DHS and reported to OPA. The DHS Title X subrecipients have an obligation to provide high-quality, confidential family planning services and adhere to reporting requirements. This conflict of providing high quality, confidential care and the reporting requirements of the program could result in clinics omitting data reported to the DHS or making the choice to leave the Title X program.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Burden Hours Are Underestimated OPA has underestimated the burden hours required – 36 per grantee - to make changes to collecting and reporting data elements in a new FPAR. The DHS vendor working with subrecipients to collect encounter-level data estimates 600 hours to build the FPAR 2.0 requirements. The DHS estimates FPAR 2.0 elements will need to be approved in July 2021 to design and deploy the modifications of current modules to support the new reporting requirements.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
VDH requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges Title X grantees and service sites currently are facing. Any VDH staff who would otherwise have been assigned to FPAR 2.0 preparation have been required to prioritize COVID activities. Furthermore, clinical sites have been forced to reduce their previous efforts to expand family planning services. VDH’s Title X program has experienced a 42% decline in patient volume between 2019 and 2020, and numerous Title X sites across the Commonwealth were forced to adjust hours or temporarily close. When the pandemic subsides, VDH will need to invest all available resources into rebuilding the Title X program to its previous capacity.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The current timeline for FPAR 2.0 data collection to begin on January 1, 2022 needs to be revised. In order to implement FPAR 2.0, VDH and its three federally qualified health center (FQHC) subrecipients would need to upgrade its IT infrastructure.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, VDH is in the difficult position of having to wait while the time window needed to implement systems changes narrows.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Currently, VDH estimates it will take 36 months to pilot, implement, test, and revise the modifications necessary to collect and report the encounter-level data required by FPAR 2.0, as well as provide the appropriate training to staff.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Current OPA timelines assume a level of baseline technology at both the Title X grantee and subrecipient levels. However, VDH does not have an EHR system. Instead, VDH uses paper forms and WebVision, a homegrown legacy system that tracks information for billing purposes, to collect FPAR data for aggregate submission. Any Title X sites that do not have an EHR will not be able to procure and implement an EHR by January 1, 2022, as EHR implementation typically takes 9 to 11 months, with three months for planning and six to eight months for implementation.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
VDH is unable to procure an EHR until the Virginia General Assembly allocates considerable and sustained funding to the agency for this purpose. If FPAR 2.0 goes into effect on January 1, 2022, VDH will need to collect and perform manual data entry of FPAR 2.0’s 45 proposed data elements for every visit, and then determine how to de-identify line-item records so that they can be transmitted securely.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
VDH collects the specimen during the patient’s family planning visit, and then sends the specimen to LabCorp for analysis. LabCorp then bills the patient directly for costs related to the test. While LabCorp notifies VDH of the patient’s test results, VDH does not have an electronic mechanism for filing this information. This information is currently filed in the patient’s paper chart and would then become part of the patient’s treatment plan. VDH partners with LabCorp to collect the necessary aggregate data for FPAR, but FPAR 2.0 would require a specific test result to be electronically connected to a specific encounter, a functionality that does not exist with VDH’s current IT systems.	If indicated by the clinician, STI testing results should be ordered and recorded in the encounter record for appropriate follow-up care. Acknowledging that there are sometimes technical challenges in attaching the STI lab results to the encounter record, OPA is working to develop alternative reporting guidance for lab values.
VDH also requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study, was published in 2009 using data collected from Title X grantees more than twelve years ago.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit). While AFHP appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Under the best of circumstances, OPA’s proposal for FPAR 2.0 is flawed. Not only does FPAR 2.0, as proposed, require cost and time (i.e., burden hour) investments that are exponentially higher than the outdated estimates published in the Federal Register (86 FR 9077);	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
it also puts forward data collection requirements that far exceed the minimum amount of data needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
The implementation of the Title X 2019 Rules created an enormous burden and negatively impacted AFHP’s capacity to provide low-income individuals with family planning and related preventive health services. Significant time was spent on successfully implementing the 2019 Title X Final Rule at the grantee and sub-recipient level that took time away from activities to accomplish goals and objectives in AFHP’s work plan.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The COVID-19 response in 2020 has significantly decreased client numbers. Over the past two years, AFHP saw 24% (n=7,941) fewer clients in 2019 and 39% (n=10,177) fewer clients in 2020. AFHP is moving closer to stabilizing our network as we continue supporting and onboarding subrecipients. Most recently, the focus for many subrecipients has shifted to administering the COVID-19 vaccine to health center staff as well as the public. Any attempt to implement FPAR 2.0 in accordance with current timelines will severely disrupt and undermine our ability to respond to these top priorities.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, AFHP would need to upgrade its information technology (IT) infrastructure, as would its 12 subrecipients. Currently, we estimate it will take at least six months to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
April 9, 2021, OPA has not released final specifications (i.e., instructions for how to collect) for FPAR 2.0’s data elements, including how to map each data element and response options to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
After making system upgrades, AFHP and its 12 subrecipients (which operate over 55 service sites) will require another six months to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
AFHP requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden https://www.arizonafamilyhealth.org estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study 2, was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the data collected no longer being relevant. It is inappropriate for OPA to use data collected from the 2009 FPAR Burden Study to quantify costs for implementing the encounter-level data reporting system currently proposed, as these estimates relate to a completely different iteration of the proposed overhaul of FPAR that would be substantially less burdensome on grantees and subrecipients.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Secondly, due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems. In AFHP’s Title X network, there are 12 subrecipients using five different EHR platforms.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
AFHP estimates that implementing FPAR 2.0 as proposed at the grantee-level will amount to over 200 hours and over $18,000 in one-time non-labor costs. Furthermore, AFHP estimates that each of its 12 subrecipients will outlay an average of $5,000 in non-labor costs to implement FPAR 2.0, for an estimated total of $60,000 in non-labor costs across this single Title X grantee network. We estimate that implementing FPAR 2.0 will amount to about $6,000 in one-time labor costs. This estimate is based on the cost of two staff persons working a combined 75 hours on tasks related to implementation. We also estimate that each of our 12 subrecipients will spend an average of 64 hours implementing FPAR 2.0, for an estimated total of about $38,000 in one-time labor costs across this single Title X grantee network. Costs for ongoing operations and maintenance are not included in these estimates. They also do not include the additional time it will take health care providers and staff at Title X service sites to document more than 20 additional data elements as part of every single Title X visit.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
With the addition of 23 new data elements – many of which are irrelevant to monitoring Title X program compliance and accountability to the above performance goals – FPAR 2.0 represents an effort that has no intention of being minimally burdensome.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health.6 However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted. Additionally, FPAR 2.0 is not described as a supplement to the National Survey of Family Growth in Supporting Statement A. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
New Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Systolic and Diastolic Blood Pressure Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Smoking Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Height, Weight, BMI AFHP believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.13 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Element: National Provider Identifier (NPI) While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act (HIPAA) - covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in 2020, 33% of all Title X family planning encounters in AFHP’s network were performed by other services providers, including registered nurses, licensed practical nurses, health educators, and social workers. As such, many of our providers delivering Title X services do not have individual NPI to report for FPAR 2.0.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.17 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.18 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels (e.g., patient identifier, visit date, date of birth)	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit). While NJFPL appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused. At the same time, OPA must plan and initiate a new process for transitioning to a new data collection and reporting system with continued stakeholder involvement.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
The implementation of the 2019 Title X Final Rule had a dramatic impact on NJFPL’s Title X network. 46% decline in the network’s capacity after an estimated one in four service sites left the Title X program in response to the 2019 Title X Rule1 – implementation of FPAR 2.0 simply is not feasible.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable. To implement FPAR 2.0, NJFPL would need to upgrade to its information technology (IT) infrastructure, as would its 11 Title X subrecipients. Currently, we estimate it will take 3-6 months to implement and test the system upgrades needed to collect and report encounter-level data through FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
As of April 12, 2021, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is currently developing guidProposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff. ance documents and other TA materials for technical and nontechnical staff to facilitate to grantees’ internal training processes and promote reporting readiness. OPA also acknowledges challenges building capacity to report encounter-level data and is working to provide alternate reporting pathways for those who are not able to meet the existing timeline. This will require project officer approval and a plan to ultimately transition to FPAR 2.0. OPA also notes that the transition to encounter-level reporting was initiated in 2012, and grantees have been engaged in the process since that time.
NJFPL and its subrecipients, which operate 35 service sites, will each require 4-6 weeks to train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
NJFPL requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study2, was published in 2009 using data collected from Title X grantees more than twelve years ago.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems. In NJFPL’s Title X network, there are 11 subrecipients using six EHR platforms. As NJFPL seeks to expand New Jersey’s Title X family planning provider network, potential subrecipients either not using EHR platforms or transitioning from one platform to another create additional challenges for adhering to the proposed FPAR 2.0 requirements. NJFPL estimates that implementing FPAR 2.0 as proposed at the grantee-level will amount to $25,000 in one-time non-labor costs.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health.6 However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]. These sexual activity-related data fields also are not needed to monitor our Title X network’s accountability to program goals.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted, including the three referenced elements.
New Data Element: Future Pregnancy Intention Reported Another example of a proposed data element that is inconsistent with current research on the provision of patient-centered contraceptive care is the FPAR 2.0 data element tracking patients’ intention to either become pregnant or prevent a pregnancy in the next year. Research suggests that many patients cannot articulate their pregnancy intentions over the next year; doing so is inconsistent with how they think about and approach their reproductive lives.8 9 This is particularly true for low-income populations.10 Indeed, not all individuals overtly plan to have children or not have children, suggesting that asking about reproductive "intentions" or "plans" may be problematic.11 Asking patients this kind of a question at every visit, regardless of the reason for the visit, could compromise the patient-provider relationship by breaking rapport and shifting the visit away from what the patient wants. Reflecting current research that patients prefer to be asked about their service needs than about pregnancy intentions or desires12, NFPRHA recommends that FPAR 2.0 use a more patient-centered approach to measurement. An example of an alternative measure that assesses patients’ desire for contraceptive services is the Self-Identified Need for Contraception (SINC)13 question	Future pregnancy intention was deleted. SINC is included as an optional element as it is still in development and not yet NQF endorsed.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.14 Furthermore, there is no way for NJFPL to differentiate whether an HPV test was done as part of routine screening or as a follow up after an abnormal screening test or for post-treatment surveillance.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Systolic and Diastolic Blood Pressure Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Smoking Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Height, Weight, BMI NJFPL believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.19 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.20 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Element: National Provider Identifier (NPI) While most advanced practice clinicians have a NPI number, they are not required for those providers who do not transmit Health Information Portability and Accountability Act- (HIPAA) covered data or those who provide services “incident to” another provider. Furthermore, only advanced practice clinicians may obtain an NPI; however, in some instances, Title X family planning encounters are performed by other service providers, such as registered nurses, licensed practical nurses, health educators, and social workers.	NPI/NPI2 to be reported when available. NPI's can be held by healthcare providers other than physicians and including registered nurses (https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf).
Confidentiality of Sensitive Personal Health Information NJFPL requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.23 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.24 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
The proposed changes will substantially burden Title X providers in ways not captured in the burden estimates in the document, thereby damaging the Title X program’s capacity to meet its goals. The Title X clinical network as it is currently constituted is highly unlikely to be able to fulfill the reporting requirements in this document in ways such that the data would actually be useful and reliable for the research and program purposes outlined. And adding these requirements will affect healthcare providers’ ability and willingness to serve clients under the Title X program. It may actually encourage providers to opt out of the program, thereby reducing its effectiveness and its service to populations most in need.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Marginalized populations may be less likely to seek services at Title X providers because of concerns about collection of identifiable data. Title X is a key safety-net program serving some of the most marginalized in the US population. Substantial research indicates that marginalized populations, including young people, people without proper documentation, and others who are underserved by the health care system are particularly sensitive to privacy concerns when they seek healthcare. By introducing a new private identifiable data collection and transmittal effort for the program designed to serve these populations, FPAR 2.0 is likely to make precisely those who it is designed to serve less likely to use its services.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Currently collected in aggregate under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to collect visit information at the encounter level and build on the existing data collection and reporting system by adding 23 new data elements to FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit). While Unity Health Care appreciates the need for a more robust data system for monitoring and improving program performance and is committed to implementing such a system, the current FPAR 2.0 project must be paused. At the same time, OPA must plan and initiate a new process for transitioning to a new data collection and reporting system with continued stakeholder involvement	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
As of 4/8/2021, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows. Currently, we are unable to estimate the full impact of the modification necessary to implement and test the systems upgrades needed to collect and report encounter-level data through FPAR 2.0.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
After making system upgrades, Unity Health Care, Inc and its subrecipients will require ample time schedule and train health care providers and staff on how to collect new data elements, conduct preliminary data collection, run reports to ensure data mapping is correct, and perform quality assurance of preliminary data collected, as needed.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.
Unity Health Care, Inc requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are extremely low and based on an inappropriate and incredibly outdated source. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study2, was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the data collected no longer being relevant.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from Title X service sites to grantees, necessitating each grantee-subrecipient dyad to invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems.	OPA has engaged grantees and EHR vendors in recent years to provide technical specifications and provide uniform guidance for collecting, formatting, and transmitting data. Earlier this year, OPA began information- and requirements-gathering meetings with grantees from each Department of Health and Human Services region to identify anticipated reporting challenges and approaches for minimizing reporting burden. OPA is also currently establishing outreach to EHR vendors to discuss opportunities to enhance implementation guides, options for file formats, and other guidance for IT representatives from EHR vendors and grantee organizations. Additionally, OPA will provide flexible options for acceptable file formats, including specifications for submitting flat files (that is, files that do not require EHR vendor technology).
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health.6 However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and threatens the patient-provider relationship. It also is inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)]	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted, including the referenced elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Systolic and Diastolic Blood Pressure Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Smoking Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Height, Weight, BMI Unity Health Care, Inc believes the collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.13 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.14 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Confidentiality of Sensitive Personal Health Information Unity Health Care, Inc requests further clarification on the steps OPA will take to maintain the confidentiality of the sensitive personal health information collected by FPAR 2.0. Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.17 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.18 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved. Furthermore	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
OPA has not provided information on the HIPAA Security Rule Standards it will adopt to ensure the appropriate consent and safeguarding of this encounter-level data at the federal, grantee, and subrecipient levels; for example, specifying encryption standards for data at rest and in motion. Given the cybersecurity issues that all organizations currently are facing, it seems imprudent to move forward with FPAR 2.0 without releasing more information about – and seeking stakeholder feedback on – the steps that OPA will take to protect FPAR 2.0’s encounter-level data from unauthorized access, use, and disclosure, as well as what steps we will be required to take.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
Currently collected under OMB No. 0990-0221, this new data collection, “FPAR 2.0”, proposes to build on the existing data collection and reporting system by adding 23 new data elements to the FPAR’s standard set of data elements (for a total of 45 data elements to be collected at every visit). While the Sexual and Reproductive Health Program appreciates the need for a contemporary data system for collection, management and analysis to improve program performance and is committed to implementing such a system, the current FPAR 2.0 project should be paused.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
The Washington State Department of Health’s Sexual and Reproductive Health Program requests that OPA establish a new timeline for FPAR 2.0 planning and implementation given the challenges all states and providers are facing. Even in the absence of the above challenges, the current timeline for FPAR 2.0 data collection to begin on January 1, 2022 is unworkable, in part because FPAR 2.0’s data elements have not been released, including how to map each data element and response option to standardized value sets. In the absence of these specifications, we are in the difficult position of having to wait while the time window needed to implement systems changes narrows.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
The Washington State Department of Health’s Sexual and Reproductive Health Program requests that OPA complete an up-to-date burden study to provide a complete and accurate estimate of the burden associated with implementing FPAR 2.0. Cost burden estimates in the Public Comment Request are significantly lower than those reported by our providers for comparable projects. The source for estimates, the Family Planning Annual Report (FPAR) Burden Study , was published in 2009 using data collected from Title X grantees more than twelve years ago. Since this time, several developments have taken place that translate to the estimates no longer being accurate.	OPA is offering a 3-year phased implementation for those grantees who cannot transition to FPAR 2.0 on the existing timeline to allow more time for full implementation. Based on grantee feedback and surveys, OPA postponed FPAR 2.0 implementation from 2020 to 2021. OPA is updating the burden estimate in the OMB submission. OMB burden estimates assess the annual burden required for data collection and reporting. To address implementation burden, OPA provided a non-competitive grant supplement of $160,000 early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. Once implemented, a standards-based data collection should reduce reporting burden. OPA continues to incorporate working group feedback into data system development through regular communications and meetings. TA materials are being developed based on feedback to help transition.
Due to challenges with interoperability (i.e., electronic sharing of data between systems), there is no “one size fits all” approach for implementing FPAR 2.0 electronic reporting from our network of providers to the department, necessitating that our providers invest in upgrading to electronic systems (as applicable) and establishing interoperability between their respective systems. Our network of providers use several different EMR providers.	OPA has engaged grantees and EHR vendors in recent years to provide technical specifications and provide uniform guidance for collecting, formatting, and transmitting data. Earlier this year, OPA began information- and requirements-gathering meetings with grantees from each Department of Health and Human Services region to identify anticipated reporting challenges and approaches for minimizing reporting burden. OPA is also currently establishing outreach to EHR vendors to discuss opportunities to enhance implementation guides, options for file formats, and other guidance for IT representatives from EHR vendors and grantee organizations. Additionally, OPA will provide flexible options for acceptable file formats, including specifications for submitting flat files (that is, files that do not require EHR vendor technology).
New Data Elements: Sexual Activity The Supporting Statement for the Title X FPAR 2.0 describes how FPAR 2.0 will supplement the federally funded National Survey for Family Growth (NSFG), a population-level, nationally representative dataset that gathers information on pregnancy and births, infertility, use of contraception, and general and reproductive health. However, while NSFG surveys a representative sample of respondents and allows them to voluntarily respond, the data elements that will be collected and reported through FPAR 2.0 will be required for every patient visit. More specifically, OPA has proposed that Title X service sites report the following three data fields for patients at every visit: Ever had sex, Sex in the last 3 months, and Sex in the last year. Asking these three data points at every visit is burdensome and inconsistent with current best practice guidelines, which recommend assessing whether an adult or adolescent patient is sexually active only annually [unless the patient is at increased risk for infection or is seeking evaluation and treatment for sexually transmitted infections (STIs)].	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted, including the referenced elements. Additionally, no where in Supporting Statement A is FPAR 2.0 described as a supplement to the National Survey of Family Growth. In regards to one element (family planning method use by sex and age, p. 5), it is noted that FPAR 2.0 data could be used to compare the program's contraceptive method-mix with a nationally representative sample, such as NSFG. In section 4, Efforts to Identify Duplication and Use of Similar Information (p. 8), NSFG is specifically referenced as an inappropriate source of information to represent the Title X population, thus supporting the need for FPAR 2.0.
New Data Elements: Cardiovascular Risk Factors - Height, Weight, BMI The collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From+ a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.13 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.14 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Element: Future Pregnancy Intention Reported NFPRHA recommends that FPAR 2.0 use a more patient-centered approach to measurement. An example of an alternative measure that assesses patients’ desire for contraceptive services is the Self-Identified Need for Contraception (SINC) question developed by the University of California, San Francisco (UCSF) Person-Centered Reproductive Health Program in consultation with Reproductive Justice advocates. Of note, UCSF has an award from OPA to develop a new electronic Clinical Quality Measures (eCQMs) of contraceptive provision using the SINC question to define the denominator. As such, use of the SINC question in FPAR 2.0 would be consistent with other initiatives underway at OPA. Use of this type of measure also would facilitate the removal of problematic data elements related to sexual activity, which have been included to identify whether a patient is perceived as “at risk” for pregnancy.	The Patient-Centered Contraceptive Counseling (PCCC) Measure is not intended to be implemented within an EHR specification so it cannot be implemented within the FPAR 2.0 data elements. OPA has plans to develop technical assistance to work with grantees to implement the PCCC, as designed, when certain thresholds of utilization are met.
Data Elements: Cervical Cancer Screening FPAR 2.0 suggests the Title X service sites collect and report five different data elements related to cervical cancer screening: Pap test at this visit, Last Pap result, Pap test in the last five years, HPV test performed at this visit, and HPV test result. Collecting and reporting all five data elements for every Title X visit would carry substantial burden with minimal benefit. The collection of information on a patient’s Pap (at current and previous visit) and HPV tests performed may be helpful as quantitative measures; for instance, to compute the number of tests provided during a specified period, the distribution of abnormal cytology results, or use of different cervical cancer screening technologies (cytology-alone, hrHPV-alone, co-testing) during a specified period. However, the utility of collecting of Pap test in the last five years and HPV test results are questionable, as no national guideline recommends cervical cytology alone at a five-year interval and there is no national benchmark pertaining to the rate of tests that should come back as positive.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Systolic and Diastolic Blood Pressure Separate reporting of systolic and diastolic blood pressure measurements does not make sense clinically, as the interpretation of a single measurement at a point in time must be tempered by the age of the patient, anxiety level when blood pressure is measured (i.e., “white coat” hypertension), and other factors. Unless the systolic and diastolic pressures are quite elevated, the diagnosis of hypertension cannot be made without multiple measurements on several separate occasions. If increasing control of high blood pressure is a priority for OPA, this data element should be reconfigured to identify whether diagnosis of hypertension has been made or if screening for elevated blood pressure has been performed consistent with nationally recognized guidelines.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Smoking Self-reported smoking status also is not helpful as a quality metric. If this topic is a priority for OPA, this data element should be reconfigured to determine to report the intervention(s) offered to tobacco smokers, using those listed by the US Preventive Services Task Force.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
New Data Elements: Cardiovascular Risk Factors - Height, Weight, BMI The collection of height and weight data, presumably to calculate body mass index (BMI), is problematic. From a clinical perspective, there is no logical rationale to record and report body weight at every visit, and OPA does not state why it is necessary to collect this information and how it will be used in the Supporting Statement for the Title X FPAR 2.0.13 Even when collecting a patient’s height and weight data is clinically indicated, such measurements are not reliable for identifying whether that patient is overweight or obese – and, in turn, at risk for cardiovascular disease. Developed for and tested on a sample of predominantly white European men, BMI is not a useful indicator of health, especially for women of color, because it because it fails to account for differences in body composition, fitness levels, and nutritional differences.14 Furthermore, the practice of weighing clients at every visit – even health education sessions or when not clinically indicated – may deter clients from accessing services due to experiences of body shame and weight discrimination.	The FPAR 2.0 data collection builds on data already reported in FPAR 1.0 and adds additional detail that will allow OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Currently, aggregate level data collection limits analyses primarily to descriptive analytics that are of limited utility. Encounter level data collection will allow for richer and more detailed analysis. Several of the new data elements are related to clinical quality measures only recently developed and endorsed (in 2016) or Quality Family Planning guidelines (first released in 2014). The FPAR 2.0 data collection is not intended to drive the clinical encounter. If the clinical encounter includes information collected in FPAR 2.0, only then should it be recorded. It will not be necessary to collect every single element in every single encounter. Data should only be collected if needed for the encounter. In response to this and similar feedback, several elements were revised or deleted.
Confidentiality of Sensitive Personal Health Information Confidentiality is a hallmark of the Title X program, and all patients, including adolescents, are guaranteed confidential services. Such protections are grounded in the statute, regulations, and case law. Further, they are grounded in medical and ethical standards and reflect research demonstrating that, without access to confidential care, some patients would not seek needed health services.17 Despite this assurance, the Supporting Statement for the Title X FPAR 2.0 fails to address how OPA will maintain the confidentiality of the sensitive personal health information it wants to collect through FPAR 2.0.18 While encounter-level data will be de-identified, OPA has not released specifications for how the patient identifier data element will be used in a way that ensures that patient confidentiality is preserved.	OPA is prioritizing client confidentiality. Previous consultations with the HHS Privacy Officer indicate that the level of detail collected by FPAR 2.0 will not require a Systems of Record Notice because OPA does not plan on using a personal identifier to retrieve individual records. OPA will further confirm these details during the Enterprise Performance Life Cycle (EPLC) and Authority to Operate (ATO) process. OPA is working with the data system contractor to establish data masking and reporting procedures using best practices and in accordance with all federal regulations.
As of April 9, 2021, OPA has not released final specifications for (i.e., instructions for how to collect) FPAR 2.0’s data elements, including how to map each data element and response option to standardized value sets; nor has it published the anticipated data elements on its website. In the absence of these specifications, grantees are in the difficult position of having to wait while the time window needed to implement systems changes narrows. Initiating upgrades before final specifications are available would be wasteful, as inconsistencies would require revisions that carry additional costs and burden hours spent.	Proposed EHR changes will use standardized code systems to increase ease of adoption. OPA is also working to add equivalent code sets to further increase ease of adoption. OPA provided a non-competitive grant supplement early in 2021 to assist with FPAR 2.0 implementation and announced on 5/27/21 an additional, planned grant supplement to be awarded in FY2021 worth 6-7% of total grant awards. OPA is also reaching out to EHR vendors to assess implementation needs and is developing plain language technical assistance materials for grantees to use when discussing needed changes with EHR/IT staff.