CMS-10432 - Supporting Statement A - Passback_Program Responses_v5 -- CLEAN

Supporting Statement – Part A

Revised and New Procedural Requirements for the FY 2016 Inpatient Psychiatric Facility

Quality Reporting (IPFQR) Program

CMS-10432, OMB 0938-1171

This package is associated with the August 5, 2015, final rule: CMS-1627-F, RIN 0938-AS47.

Background

Pursuant to section 1886(s)(4) of the Social Security Act, as amended by sections 3401 and 10322 of the Affordable Care Act (ACA), starting in fiscal year (FY) 2014, and for subsequent fiscal years, Inpatient Psychiatric Facilities (IPF) shall submit pre-defined quality measures to the Centers for Medicare & Medicaid Services (CMS). IPFs that fail to report on the selected quality measures and comply with other administrative requirements will have their IPF prospective payment system (PPS) payment updates reduced by 2.0 percentage points. To comply with the statutory mandate, we are updating the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program for FY 2017 and FY 2018.

1. Justification

1. Need and Legal Basis

Section 1886(s)(4)(C) of the Act requires that, for FY 2014 (October 1, 2013, through September 30, 2014) and each subsequent fiscal year, each psychiatric hospital and psychiatric unit shall submit to the Secretary data on quality measures as specified by the Secretary. Such data shall be submitted in a form and manner, and at a time, specified by the Secretary.

The following is a list of measures included in the IPFQR Program and a brief explanation of their inclusion in this program.

The Hospital-Based Inpatient Psychiatric Services (HBIPS) measures were chosen because The Joint Commission (TJC) has utilized them for several years to evaluate and assess related quality of care in their member IPFs. CMS determined that these same measures, and the data collection definitions that have been tested and proven to improve quality of care provided and to identify areas of need for quality of care improvement, are valuable within all CMS-certified IPFs. However, in this ICR, CMS is removing one of these measures for FY 2017 (HBIPS-4) for 2017 and subsequent years, and two of these measures (HBIPS-6 and HBPIS-7) for FY 2018 and subsequent years, as CMS has adopted new measures on these subjects. Reporting on HBIPS-2, HBIPS-3, and HBIPS-5 will continue in the IPFQR Program.

• The SUB-1 and SUB-2 and SUB-2a measures are specified by TJC to evaluate and assess quality of care for inpatient hospitals. In this ICR, CMS is adding the SUB-2 and SUB 2-a measure for FY 2018 and subsequent years, the SUB-1 measure was previously adopted and is continuing in the program. CMS has determined that these measures relate to important aspects of the National Quality Strategy (NQS), and that these measures will help to improve quality of care and the patient-centered aspect of care across multiple settings. Documentation on the TJC website at the link below provides details on the specification of this measure.

http://www.jointcommission.org/specifications_manual_for_national_hospital_inpatient_quality_measures.aspx. 

• The FUH measure was identified as a high-impact measure for improving care for the vulnerable dual eligible population. This National Quality Forum (NQF)-endorsed measure addresses several principles of the NQS, while focusing on the person-centered episode of care. Information regarding this measure, including evidence of its impact, can be found at the link below.

http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=70617

• The Assessment of Patient Experience of Care measure was chosen because it will begin to provide information on a NQS priority area that was previously unaddressed in the IPFQR Program, namely, patient and family engagement and experience of care.

• The Use of an Electronic Health Record measure provides important information about an element of IPF service delivery shown to be associated with the delivery of quality care. It also provides useful information to consumers and others in choosing among different facilities. Moreover, this measure supports the exchange of health information across care partners and during transitions of care, which is a priority area for a number of Department of Health & Human Services (HHS) initiatives.

• The IMM-2 measure provides information on influenza vaccination in IPFs. Similarly, the Influenza Vaccination Coverage Among Healthcare Personnel measure provides information on influenza vaccination among healthcare personnel (HCP) in IPFs. Improvements in influenza vaccination can reduce unnecessary hospitalizations and secondary complications. Together, therefore, these measures provide useful information for both IPFs and consumers alike on the quality of care provided in specific facilities. The forms for the Influenza Vaccination Coverage Among Healthcare Personnel measure are maintained by the Centers for Disease Control and Prevention and can be found http://www.cdc.gov/vaccines/hcp.htm.

• The TOB-1, TOB-2 and TOB-2a, and TOB-3 and TOB-3a measures provide information on tobacco use screening, and tobacco use treatment provided or offered and tobacco use treatment, including at discharge. In this ICR, CMS is adding the TOB-3 and TOB-3a measure for FY 2018 and subsequent years, the TOB-1, TOB-2 and TOB-2a measures were previously adopted and are continuing in the program. Tobacco use is an especially important issue for persons with mental illness or substance abuse disorders, and timely tobacco dependence interventions for patients using tobacco can significantly reduce the risk of suffering from tobacco-related disease, as well as provide improved health outcomes for those already suffering from a tobacco-related disease. Inclusion of these measures encourages the uptake of tobacco cessation treatment and its attendant benefits, while also affording consumers and others useful information in choosing among different facilities.

• The Transition Record with Specified Elements Received by Discharged Patients (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure seeks to overcome gaps in care transitions caused by inadequate information that lead to avoidable adverse events and cost CMS approximately $15 billion due to avoidable patient readmissions. In this ICR, CMS is adding this measure for FY 2018 and subsequent years. Public reporting of this measure would afford consumers and their families or caregivers useful information in choosing among different facilities and would promote our NQS priority of Communication and Care Coordination. More information on this measure can be found at http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit=PCPI.

• The Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure narrows gaps in care transitions that result in adverse health outcomes for patients and about $15 billion in medical costs to CMS due to readmissions. In this ICR, CMS is adding this measure for FY 2018 and subsequent years. Public reporting of this measure will afford consumers, and their families or caregivers, useful information in choosing among different facilities because it communicates how quickly a summary of the patient’s record will be transmitted to his or her other treating facilities and physicians, improving care. This measure will also promote our NQS priority of Communication and Care Coordination. More information on this measure can be found at http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit=PCPI.

• The Screening for Metabolic Disorders measure requires screening for patients on antipsychotics. In this ICR, CMS is adding this measure for FY 2018 and subsequent years. Antipsychotics have been shown to be related to metabolic syndrome, and this measure seeks to reduce risk that is caused by the delivery of healthcare. This measure promotes the NQS priority of Making Care Safer, which seeks to reduce risk that is caused by the delivery of healthcare

Section 1886(s)(4)(E) of the Act requires the Secretary to establish procedures for making public the data submitted by IPFs under the IPFQR Program. In order for CMS to publish the measure rates, IPFs are required to submit the Notice of Participation (NOP) form. By such submission, IPFs indicate their agreement to participate in the IPFQR Program and that they shall submit the required data pertaining to the thirteen (13) quality measures for the FY 2017 payment determination and the sixteen (16) quality measures for the FY 2018 payment determination. In additional, IPFs give their consent to publicly report their measure rates on a CMS website. CMS is mindful and respectful that IPFs may choose not to participate or may choose to withdraw from the IPFQR Program. To this end, our procedures include the necessary steps that IPFs have to take to indicate their intent.

As part of our procedural requirements, we require that IPFs acknowledge the accuracy and completeness of submitted data. We seek to collect information on valid, reliable, and relevant measures of quality, and to share this information with the public; therefore, IPFs must submit the Data Accuracy and Completeness Acknowledgement (DACA). IPFs may need to submit the Notice of Participation form, which can also be used to indicate an IPF’s intent not to participate or withdraw from the Program. In our effort to foster alignment across quality reporting programs, we removed the Extraordinary Circumstances Exception form and the Reconsideration Request form and are now submitting these forms as part of the Hospital Inpatient Quality Reporting (HIQR) Program’s PRA package (OMB control number 0938-1022; CMS-10210). While IPFs may also need to complete and submit these forms, the associated burden is addressed in the HIQR PRA package.

2. Information Users

• IPFs: The main focus for an IPF is to: examine individual IPFs’ specific care domains and types of patients, and compare present performance to past performance and to national performance norms; use quality measures to evaluate the effectiveness of care provided to specific types of patients and, in the context of investigating processes of care, to individual patients; monitor quality improvement outcomes over time; assess their own strengths and weaknesses in the clinical services that they provide; address care-related areas, activities, or behaviors that result in effective patient care; and alert themselves to needed improvements. Such information is essential to IPFs in initiating quality improvement strategies. This information can also be used to improve IPFs’ financial planning and marketing strategies.

• State Agencies/CMS: Agency profiles are used in the process of comparing an IPF’s results with its peer performance. The availability of peer performance enables state agencies and CMS to identify opportunities for improvement in the IPF and to evaluate more effectively the IPF’s own quality assessment and performance improvement program.

• Accrediting Bodies: National accrediting organizations, such as TJC, or state accreditation agencies may wish to use the information to target potential or identified problems during the organization’s accreditation review of that facility.

• Beneficiaries/Consumers: The IPFQR Program publicly reports data through a CMS website. This data provides information for consumers and their families on the quality of care provided by individual facilities, allowing them to compare patient outcomes between facilities and against the state and national average. The website provides information in consumer-friendly language and offers a tool to assist consumers with selecting a hospital.

CMS uses the information submitted on the measures in the IPFQR Program (see section 12 of this document for a list of measures in the IPFQR Program) to identify opportunities for improvement in the coordination of care and to effectively target quality improvement initiatives to meet the statutory requirements of the Affordable Care Act Sections 3401 and 10322 as mandated for the agency. The information gathered in turn is made available to IPFs for their use in specifying areas of need for internal quality improvement initiatives. For information about the updates to the program, as finalized in the 2016 IPF PPS Final Rule, please see Section 15 of this document.

3. Use of Information Technology

IPFs are able to utilize electronic means to submit/transmit their forms and data via a CMS- provided secure web-based tool, which is available on the QualityNet website. IPF users are required to open an account to set up secure logins and then will be able to complete all the necessary forms/applications as may be applicable to their circumstance (e.g., NOP, DACA, Request for Reconsideration).  We have included copies of these forms within this package.

A Web-based Measure online tool is used for data entry through the QualityNet website.  Data are stored to support retrieving reports for hospitals to view their measure rates/results. Facilities are sent a preview report via QualityNet Exchange prior to release of data on the CMS website for public viewing. 

4. Duplication of Efforts

Facilities that currently collect and report data on TJC measures can use the same information to report to CMS, which avoids duplication of efforts and reduces burden to the IPFs. As for collection of the FUH measure, CMS will collect such data using Medicare Part A and Part B claims; therefore, it will have no burden on IPFs.

5. Small Business

Information collection requirements are designed to allow maximum flexibility specifically to small IPF providers participating in the IPFQR Program. This effort assists small IPF providers in gathering information for their own quality improvement efforts. For example, we provide a help-desk hotline for troubleshooting purposes and 24/7 free information available on the QualityNet website through a Questions and Answers (Q&A) functionality.

6. Less Frequent Collection

We have designed the collection of quality of care data to be the minimum necessary for reporting of psychiatric data on measures considered to be meaningful indicators of psychiatric patient care by the NQF. To this end, we only require a single, annual report of measure data from facilities.

7. Special Circumstances

Although IPF participation is voluntary, all eligible IPFs must submit their data to receive the full market basket update for a given fiscal year. If data are not submitted to CMS, the IPF receives a reduction of 2 percentage points from their Annual Payment Update (APU) unless CMS grants an exception or exemption.

8. Federal Register Notice/Outside Consultation

The August 5, 2015 (80 FR 46652), final rule is serving as the 30-day Federal Register notice. The rule was placed on file for public inspection on July 31, 2015. Comments are due 30-days later, on August 31.

The May 1, 2015 (80 FR 25012), proposed rule served as the 60-day Federal Register notice. The rule was placed on file for public inspection on April 24, 2015. Comments were due 60-days later, on June 23. No PRA-related comments were received.

CMS is supported in this initiative by TJC, the NQF, and the Agency for Healthcare Research and Quality (AHRQ). These organizations, in conjunction with CMS, will provide technical assistance in developing or identifying quality measures, and assist in making the information accessible, understandable, and relevant to the public.

9. Payment/Gift to Respondent

No other payments or gifts will be given to respondents for participation.

10. Confidentiality

All information collected under this initiative is maintained in strict accordance with statutes and regulations governing confidentiality requirements, which can be found at 42 CFR Part 480. In addition, the tools used for transmission of data are considered confidential forms of communication and are Health Insurance Portability and Accountability Act (HIPAA)-compliant.

11. Sensitive Questions

No case-specific clinical data elements will be collected for the IPFQR program. Pursuant to 42 CFR Part 480, no case-specific clinical data will be collected or released to the public.

12. Burden Estimate (Total Hours and Wages)

For the FY 2017 Program we had previously submitted an ICR for data collection on 14 measures. In the associated Final Rule Notice, we reduced this requirement to 13 measures by removing the requirement to report on HBIPS-4. For the FY 2018 Program, we are requiring 16 measures. This is based on the FR decision to remove two previously finalized measures (HBIPS-6 and HBIPS-7) and add five additional measures (SUB-2/2a, TOB-3/3a, Transition Record with Specified Elements Received by Discharged Patients, Timely Transmission of Transition Record, and Screening for Metabolic Disorders). In our burden calculation, we have included the time used for chart abstraction and for training personnel on collection of chart-abstracted data and aggregation of the data, as well as training for submitting aggregate-level data through QualityNet. For detail on our assumptions regarding updates to training requirements, please see sub-section d, of this section – Training.

We have used data collected from facilities during FY 2015 (the most recent data available for the program at the time of submission) to improve our estimate of number of facilities and number of cases. This updated calculation results in burden estimates for data collection related to the measures for the IPFQR Program are calculated for the IPFs based on the following data:

• We estimate that there are approximately 1,617 facilities eligible to participate in the IPFQR Program (down from 1,626 previously estimated).

• We estimate that the average facility submits measure data on 431 cases per year for all of the measures except the Influenza Vaccination Coverage Among Healthcare Personnel measure, the Assessment of Patient Experience of Care measure, and the Use of an Electronic Health Record measure. For the Influenza Vaccination Coverage Among Healthcare Personnel measure, consistent with previous years, we estimate 40 cases per year. For the Assessment of Patient Experience of Care measure and the Use of an Electronic Health Record measure, consistent with prior years, since facilities are only required to submit an attestation, we estimate 0 cases.

• 1,617 IPF facilities, with approximately 431 cases per facility, results in a total of 696,927 cases per year.

• We estimate that it takes an IPF approximately 12 minutes (0.2 hours) for chart abstraction of a measure for collection based on new reporting requirements. This estimate is based on information provided by facilities through avenues such as measure development Technical Expert Panels (TEPs) on IPFQR and other quality reporting measures, as well as pilot testing of measures in the measure development process.

• We estimate an hourly labor cost of $22.37/hr for the staff required by IPFs to participate in the IPFQR Program.

Using these assumptions, we have updated our previously approved burden for the FY2017 Program Year to the following:

Tasks	Hours per IPF	Total Hours for All IPFs	Wage Rate	Cost per IPF	Total Cost for All IPFs
Chart-Abstracted Measure Data Collection and Reporting* (please note that these are average annual estimates)	783.8	1,267,405	$22.37/hr	$17,533.61	$28,351,840.90
Non-measure Data Collection and Submission	2.5	4,043	$22.37/hr	$55.93	$90,438.81
Training	2	3,234	$22.37/hr	$44.74	$72,344.58
Totals	788.3	1,274,681.1		$17,634.27	$28,514,616.20

The following sub-sections provide a detailed explanation for how the program calculated each of these estimates. These sections step the reader through the program’s calculation of updates to the previously finalized FY2017 program burden for the new estimates of number of facilities and number of cases per facility, as well as for the removal of one program measure (HBIPS-4) (sub-section b), updates for the FY 2018 program year based on the addition of 5 new measures and the removal of 3 existing measures (sub-section c), and estimates associated to training requirements (sub-section d).

1. Estimated Wages

We estimate an hourly labor cost of $22.37/hr which is based on the Bureau of Labor Statistics (BLS) wage for a Medical Records and Health Information Technician (29-2071). Additionally, per OMB Circular A-76, in calculating direct labor, agencies should not only include salaries and wages, but also “other entitlements” such as fringe benefits.¹ This Circular provides that the civilian position full fringe benefit cost factor is 36.25 percent. Therefore, we applied an hourly labor cost of $22.37/hr ($16.42/hr base salary + $5.95/hr fringe) to our burden calculations.

2. FY 2017 Payment Determination and Subsequent Years

Chart-Abstracted Measure Data Collection and Reporting

For the FY 2017 payment determination and subsequent years, we had adopted thirteen (13) measures. The following table sets out our estimated annual burden for each of these measures based on the updated estimate of cases per facility, no other changes to previous assumptions have been made in this table. Because HBIPS-4 is no longer required for the FY 2017 Program, we have omitted it from this table. As indicated below, the FUH measure has no burden.

FY 2017 Previously Finalized Measures – Updated for New Case Number Estimates

NQF Number	Measure ID	Measure Description	Estimated Cases (per facility)	Effort per Case (hours)	Annual Effort (per facility) (hours)
0640	HBIPS-2	Hours of Physical Restraint Use	431	0.2	86.2
0641	HBIPS-3	Hours of Seclusion Use	431	0.2	86.2
0560	HBIPS-5	Patients Discharged on Multiple Antipsychotic Medications with Appropriate Justification	431	0.2	86.2
0557	HBIPS-6	Post-Discharge Continuing Care Plan Created	431	0.2	86.2
0558	HBIPS-7	Post-Discharge Continuing Care Plan Transmitted to Next Level of Care Provider Upon Discharge	431	0.2	86.2
1661	SUB-1	Alcohol Use Screening	431	0.2	86.2
0576	FUH	Follow-up After Hospitalization for Mental Illness	431	0	0*
1651	TOB-1	Tobacco Use Screening	431	0.2	86.2
1654	TOB-2 TOB-2a	Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment	431	0.2	86.2
1659	IMM-2	Influenza Immunization	431	0.2	86.2
431	n/a	Influenza Vaccination Coverage Among Healthcare Personnel	40	0.2	8
n/a	n/a	Assessment of Patient Experience of Care	0	n/a	0**
n/a	n/a	Use of an Electronic Health Record	0	n/a	0**
				Annual Total	783.8

*CMS will collect this data using Medicare Part A and Part B claims; therefore, the FUH measure will have no burden on IPFs.

**Facilities are only required to submit an attestation.

Removal of HBIPS-4

We note that we had previously finalized reporting of HBIPS-4 for the FY2017 Program. In the FY 2016 IPF PPS Final Rule we removed this requirement, representing an associated decrease in burden as depicted on the following table.

NQF Number	Measure ID	Measure Description	Estimated Cases (per facility)	Effort per Case (hours)	Annual Effort (per facility) (hours)
648	HBIPS-4	Patients Discharged on Multiple Antipsychotic Medications	431	0.2	86.2

For the 1,617 IPF facilities, the aggregate burden for the 13 required FY 2017 measures is 1,267,405 hours (783.8 hours per facility times 1,617 facilities) and $28,351,842 (1,267,405 hours times $22.37/hour).

Non-measure Data Collection and Reporting

For the FY 2017 payment determination, IPFs must submit to CMS aggregate population counts for Medicare and non-Medicare discharges by age group, and diagnostic group, , and sample size counts for measures for which sampling is performed. The burden associated with submitting this data to CMS is the time and effort necessary to gather and submit this data to a CMS contractor. We estimate that it will take each facility approximately 2.5 hours to comply with this requirement. This burden across all 1,617 IPFs calculates to 4,043 hours annually at a total of $90,438.81 or $55.93 per IPF.

Tasks	Hours per IPF	Total Hours for All IPFs	Wage Rate	Cost per IPF	Total Cost for All IPFs
Non-measure Data Collection and Submission	2.5	4,043	$22.37/hr	$55.93	$90,439

3. FY 2018 Payment Determination and Subsequent Years

Beginning in FY 2018, participating IPFs will need to submit data on sixteen (16) measures. CMS is removing two (2) of the measures from the FY 2017 payment determination and adding five (5) additional measures (for details, see below and section 15 under Changes).

New Measures for FY 2018 and Subsequent Years
NQF Number	Measure ID	Measure Description	Estimated Cases (per facility)	Effort per Case (hours)	Annual Effort (per facility) (hours)
1656	TOB-3 and TOB-3a	Tobacco Use Treatment Provided or Offered at Discharge and Tobacco Use Treatment at Discharge	431	0.2	86.2
1663	SUB-2 and SUB-2a	Alcohol Use Brief Intervention Provided or Offered	431	0.2	86.2
647	n/a	Transition Record with Specified Elements Received by Discharged Patients (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care)	431	0.2	86.2
648	n/a	Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care)	431	0.2	86.2
n/a	n/a	Screening for Metabolic Disorders	431	0.2	86.2
Measures Removed for FY 2018 and Subsequent Years
NQF Number	Measure ID	Measure Description	Estimated Cases (per facility)	Effort per Case (hours)	Annual Effort (per facility) (hours)
557	HBIPS-6	Post-Discharge Continuing Care Plan Created	431	-0.2	-86.2
558	HBIPS-7	Post-Discharge Continuing Care Plan Transmitted to Next Level of Care Provider Upon Discharge	431	-0.2	-86.2
FY 2018 Payment Determination and Subsequent Years				Subtotal	Net increase of: 258.6
FY 2017 Payment Determination and Subsequent Years				Subtotal	Previous burden of: 783.8
				TOTAL	1,042.4 hours/ facility

For the 1,617 IPF facilities, the aggregate burden is 1,685,561 hours and $37,705,995.

Non-measure Data Collection and Reporting

Similar to the FY 2017 payment determination, for the FY 2018 determination IPFs must submit to CMS aggregate population counts for Medicare and non-Medicare discharges by age group, and diagnostic group, and sample size counts for measures for which sampling is performed. Our estimated burden for the FY 2018 payment determination is the same as that for the FY 2017 payment determination, namely 4,043 hours.

Tasks	Hours per IPF	Total Hours for All IPFs	Wage Rate	Cost per IPF	Total Cost for All IPFs
Non-measure Data Collection and Submission	2.5	4,043	$22.37/hr	$55.93	$90,438.81

4. Training

Because IPFs have been submitting eleven (11) of the seventeen (17) measures to CMS, the amount of training required to submit data should be reduced to training for facilities new to the Program and training on the collection of data and submission only for the five (5) new measures. Since we do not anticipate any new facilities, we are not setting out such burden.

For existing facilities, the estimated burden for training personnel for data collection and submission for current and future measures is 2 hours per facility or 3,234 total hours. The cost for this training, based on an hourly rate of $22.37, is $44.74 for each IPF or $72,344.58 for all facilities.

Tasks	Hours per IPF	Total Hours for All IPFs	Wage Rate	Cost per IPF	Total Cost for All IPFs
Training	2	3,234	$22.37/hr	$44.74	$72,344.58

5. Notice of Participation, Data Accuracy Acknowledgement, and the Vendor Authorization Form

The NoP and the DACA forms must be filled out only once for each data submission period. The Vendor Authorization form is optional. While it is estimated that these forms should take less than 5 minutes to complete, the 12 minute estimate for chart abstraction also includes the time for completing and submitting any forms related to the measures.

6. Burden Summary

The following table, similar to the table presented in sub-section a of this section, depicts the overall burden to facilities of participating in the IPFQR Program. This table represents the burden for the FY 2018 program, whereas the previous table represented the FY 2017 program.

Tasks	Hours per IPF	Total Hours for All IPFs	Wage Rate ($/hr)	Cost per IPF ($)	Total Cost for All IPFs ($)
Chart-Abstracted Measure Data Collection and Reporting* (please note that these are average annual estimates)	913	1,476,483	22.37	20,423.81	33,028,925
Training	2	3,234	22.37	44.74	72,345
Non-measure Data Collection and Reporting	2.5	4,043	22.37	55.93	90,439
Totals	917.5	1,483,760	22.37	20,524.48	33,191,709

*Includes burden associated with the preparation and submission of the Notice of Participation, Data Accuracy Acknowledgement, and Vendor Authorization Form.

13. Capital Costs (Maintenance of Capital Costs)

There are no capital costs being placed on IPFs.

14. Cost to Federal Government

The data for the IPFQR program measures will be reported directly to the QualityNet website utilizing existing system functionality.  A support contractor will be utilized to provide help desk and Q&A assistance, as well as the monitoring and evaluation effort for the program.  There will be minimal costs for development of the data entry tools because, as described earlier, the development is part of an existing software development contract. 

The labor cost for IPFQR program oversight is estimated as follows:

• Current year 1.0 FTE (2,080 hours) at GS-13 salary = $106,839

• For subsequent years 1.0 FTE (2,080 hours) at GS-13 salary = $106,839

15. Program or Burden Changes

The previously approved burden was based on IPFs submitting data on fourteen (14) measures. In the IPF PPS Final Rule Published on 08/05/2015, for the FY 2017 Program, CMS removed the requirement to report on one (1) of these previously finalized measures. So for FY 2017 IPFs are required to report on thirteen (13) measures. In the IPF PPS Final Rule, CMS added five (5) new measures for the FY 2018 Program and removed two (2) previously finalized measures. This results in a requirement to submit data on sixteen (16) measures beginning in FY 2018. Because IPFs have been submitting eleven (11) of the sixteen (16) measures to CMS, the amount of training required to submit data should be reduced to training for facilities new to the Program and training on the collection of data and submission only for the five (5) new measures.

The burden estimates for data collection related to the proposed measures for the IPFQR Program are calculated for the IPFs based on the following data:

• We estimate that there will be approximately nine (9) fewer IPF facilities (or 1,617 facilities) nationwide eligible to participate in the IPFQR Program.

• We estimate that the average facility submits measure data on 125 fewer cases per year (or 431 cases per year).

• 1,617 IPF facilities, with approximately 431 cases per facility, results in a total of 696,927 cases per year.

• We estimate that it takes an IPF approximately 3 fewer minutes (or 12 minutes) for chart abstraction of a measure for collection based on new reporting requirements.

• We estimate an hourly labor cost of $22.37 (previously $63.42).

Estimated Annual Effort Per Facility for Newly Adopted Measures

NQF Number	Measure ID	Measure Description	Estimated Cases (per facility)	Effort per Case	Annual Effort (per facility)
1656	TOB-3 and TOB-3a	Tobacco Use Treatment Provided or Offered at Discharge and Tobacco Use Treatment at Discharge	431	0.2	86.2
1663	SUB-2 and SUB-2a	Alcohol Use Brief Intervention Provided or Offered	431	0.2	86.2
647	N/A	Transition Record with Specified Elements Received by Discharged Patients (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care)	431	0.2	86.2
648	N/A	Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care)	431	0.2	86.2
N/A	N/A	Screening for Metabolic Disorders	431	0.2	86.2
				Annual Total	431

Estimated Reduction in Annual Effort per Facility for Newly Removed Measures

NQF Number	Measure ID	Measure Description	Estimated Cases (per facility)	Effort per Case	Annual Effort (per facility)
648	HBIPS-4	Patients Discharged on Multiple Antipsychotic Medications*	431	0.2	86.2
557	HBIPS-6	Post-Discharge Continuing Care Plan Created**	431	0.2	86.2
558	HBIPS-7	Post-Discharge Continuing Care Plan Transmitted to Next Level of Care Provider Upon Discharge**	431	0.2	86.2
			Annual Total		258.6
			Annual Burden Difference (431-258.6)		172.4

* - Measure removed beginning in FY 2017

** - Measure removed beginning in FY 2018

We estimate an hourly labor cost of $22.37. This labor cost is based on the Bureau of Labor Statistics (BLS) wage for a Medical Records and Health Information Technician. Additionally, per OMB Circular A-76, in calculating direct labor, agencies should not only include salaries and wages, but also “other entitlements” such as fringe benefits.² This Circular provides that the civilian position full fringe benefit cost factor is 36.25 percent. Therefore, we applied an hourly labor cost of $22.38 ($16.42 base salary + $5.95 fringe) to our burden calculations. This calculated for the 172.4 hours annual effort per facility for the FY 2018 payment determination and subsequent years results in an annual cost per facility of approximately $3,856.59. Across all 1,617 IPFs nationwide, this totals $6,236,102.80.

The estimated burden for training personnel for data collection and submission for current and future measures is 2 hours per facility. The cost for this training, based on an hourly rate of $22.37, is $44.74 for each IPF, which totals $72,344.58 for all facilities.

For the FY 2018 payment determination, IPFs must submit to CMS aggregate population counts for Medicare and non-Medicare discharges by age group, and diagnostic group, and sample size counts for measures for which sampling is performed. Because CMS is eliminating reporting this non-measure data by quarter for all measures and instead will only require this data as an aggregate, annual number, we believe that the addition of five measures leads to a net negligible change in burden associated with non-measure data collection.

Therefore, we estimate a total increase in burden of 174.4 hours per IPF or 282,004.80 hours across all IPFs, resulting in a total increase in financial burden of $3,901.33 per IPF or $6,308,447.38 across all IPFs.

Tasks	Hours per IPF	Total Hours for All IPFs	Wage Rate	Cost per IPF	Total Cost for All IPFs
Chart-Abstracted Measure Data Collection and Submission	172.4	278,770.8	$22.37	$3,856.59	$6,236,102.80
Training	2	3,234	$22.37	$44.74	$72,344.58
Totals	174.4	282,004.8		$3,901.33	$6,308,447.38

The increase is offset by errors in the submission that was approved by OMB on September 30, 2014. Specifically, the burden associated with chart-abstracted measure data considered the burden associated with added measures but neglected to consider the burden associated with the existing measures. In this regard, the 2015 burden is 1,483,760 hours (see section 12, above) with a correction of -455,245 hours.

16. Publication/Tabulation Dates

CMS will not be employing any sampling techniques or statistical methods. However, CMS will allow IPFs to report data for certain measure using sampling.

IPFs will submit their measures through a Web-based Measures Tool on the QualityNet website. After IPFs have previewed their data and agree to publicly report their measure rates, CMS will publicly display the measure rates on the CMS website. The following is the planned schedule of activities to reach these objectives.

Date	Scheduled Activity
5/1/2015	Proposed Rule Published
8/5/2015	Final Rule Published
10/1/2015	Measures Publicly Announced
1/1/2016	Start of Reporting Period
12/31/2016	End of Reporting Period
7/1/2017	Begin Data Submission
8/15/2017	End Submission Deadline
8/15/2017	Deadline to Complete Data Accuracy and Completeness Acknowledgement (DACA)
April 2018 (for FY Payment Determination)	Public Posting on CMS.gov. We will allow for a 30 day preview period approximately twelve weeks prior to the public display of data.

*Indicates an approximate estimated date

17. Expiration Date

We request a three year approval, resulting in an expiration date of 08/05/2018. We will display this expiration on associated forms.

18. Certification Statement

There are no exceptions to the certification statement.

B. Collections of Information Employing Statistical Methods

Not applicable to this collection.

1 http://www.whitehouse.gov/omb/circulars_a076_a76_incl_tech_correction.

2 http://www.whitehouse.gov/omb/circulars_a076_a76_incl_tech_correction.

16