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[NCHS] National Electronic Health Records Survey (NEHRS)

OMB: 0920-1015

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Supporting Statement A for Reinstatement with change for Clearance:

NATIONAL ELECTRONIC HEALTH RECORDS SURVEY


OMB No. 0920-1015

Discontinued 11/23/2022


Contact Information:


Sonja Williams, M.P.H.

Ambulatory Care Team Lead,

Ambulatory and Hospital Care Statistics Branch

Division of Health Care Statistics

National Center for Health Statistics

Centers for Disease Control and Prevention

301-458-4774

301-458-4032 (fax)

[email protected]


July 27, 2023

































Table of Contents



1. Circumstances Making the Collection of Information Necessary 5

2. Purpose and Use of Information Collection 5

3. Use of Improved information Technology and Burden Reduction 6

4. Efforts to Identify Duplication and Use of Similar Information 7

5. Impact on Small Businesses or Other Small Entities 7

6. Consequences of Collecting the Information Less Frequently 7

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 8

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 8

A. Federal Register Notice 8

B. Efforts to Consult Outside the Agency 8

9. Explanation of Any Payment of Gift to Respondents 8

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 8

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 10

12. Estimates of Annualized Burden Hours and Costs 10

A. Burden Hours 10

B. Burden Cost 11

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 11

14. Annualized Cost to the Government 11

15. Explanation for Program Changes or Adjustments 12

16. Plans for Tabulation and Publication and Project Time Line 12

Plans for the tabulation and publication and project time line are provided in Table 4. 12

17. Reason(s) Display of OMB Expiration Date is Inappropriate 12

18. Exceptions to Certification for Paperwork Reduction Act Submissions 12





List of Abbreviations

ERB – Ethics Review Board



List of Attachments

Att A – Applicable Laws and Regulations

Att B – 60-day Federal Registry Notice (FRN)

Att B1-B4 – 60-Day FRN Public Comments and Response

Att C – Proposed 2024 Instrument

Att D – Changes to Instrument

Att E – List of Consultants

Att F – ERB Protocol Approval Letter

Att G – Respondent Emails and Letters

Att H1 – MMWR QuickStat

Att H2 – 2021 NEHRS Flyer





Supporting Statement

National Center for Health Statistics

National Electronic Health Records Survey (NEHRS)



Shape1

  • Goal of the study: To collect information about the use of electronic health records (EHRs) systems, documentation of social determinants of health or social needs, interoperability, exchange of patient health information with public health agencies, and use of telemedicine technology among office-based and outpatient physicians in the United States.

  • Intended use of the resulting data: To provide more information about the use of EHRs, documentation of social determinants of health or social needs, interoperability, exchange of patient health information with public health agencies, and use of telemedicine technology among office-based and outpatient U.S. physicians. Data from the National Electronic Health Records Survey (NEHRS) have been used by researchers in reports and programs such as Health, United States, in addition to various other reports and research across federal, public, and international communities.

  • Methods to be used to collect data: Data will be collected directly from a sample of outpatient and office-based physician respondents through either a self-administered web questionnaire or self-administered paper questionnaire.

  • Subpopulation to be studied: Non-federally employed outpatient and office-based physicians.

  • How data will be analyzed: Data will be weighted to provide national estimates.































The National Center for Health Statistics (NCHS) requests a reinstatement with a change request for a three-year clearance to the National Electronic Health Records Survey (NEHRS) (OMB No. 0920-1015, Discontinued 11/23/2022). NCHS discontinued this data collection to allow time for the program to redesign the questionnaire. We are requesting approval to collect data for 2024, 2025, and 2026 NEHRS cohorts using the attached instrument (Attachment C). In addition to the requested approval, we also request the ability to submit non-substantive change packages, as needed, for form modifications occurring throughout the 2024-2026 survey period.

  1. Justification



  1. Circumstances Making the Collection of Information Necessary



NEHRS is a national survey of office-based physicians conducted by the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). NEHRS is sponsored by the Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS). The survey is conducted under the authority of Section 306 of the Public Health Service Act (42U.S.C. 242k) (Attachment A).



Although there are other surveys that collect information from United States office-based physicians, NEHRS is unique in that it provides nationally representative information about the use of electronic health records (EHR) and other health information technologies. It has been conducted on a regular basis as the National Ambulatory Medical Care Survey Electronic Medical Record Survey Supplement from 2008-2011, and independently as NEHRS during 2012-2021, except in 2016 and 2020. Additional justifications for conducting future rounds of NEHRS include the need for more complete data to study: (1) documentation of social needs, (2) trends in interoperability, (3) the exchange of patient health information with public health agencies, and (4) the use of telemedicine technology. The new data collections will reestablish trends of patient health information exchange with public health agencies, telemedicine technology use, as well as the evolving engagement in interoperability; particularly with respect to electronically sending, receiving, integrating, and searching for patient health information through these systems. Improving interoperability of electronic health information is a major priority for ONC, and NEHRS can provide ONC with data on physicians’ experience with interoperability.



NEHRS is the only known data source of telemedicine technology use reported by office-based physicians prior to the 2019 novel coronavirus pandemic (COVID-19). NEHRS collected data on telemedicine technology use in 2018, 2019 and 2021. The 2024 NEHRS will ask two questions on telemedicine technology so these trends can continue. NEHRS is also one of the few data sources regarding electronic public health reporting among office-based physicians prior to the COVID-19 pandemic (i.e., 2019 NEHRS). The 2024 NEHRS will repeat these questions to examine whether electronic public health reporting has changed since COVID-19. Given the investments being made to improve public health information technology infrastructure it will be important to continue measuring physicians’ rates of public health reporting in an electronic format.



The last NEHRS data collection was fielded in 2021. The 2021 NEHRS collection incorporated a shortened 4-page instrument, web and mail modes, and tracing to improve sampled physician response. There were no unweighted nonresponse survey items that exceeded 5% in the 2021 NEHRS data collection. For comparison, 2019 NEHRS had eight unweighted nonresponse items that exceeded 5%; the 2018 NEHRS had ten items. The American Association for Public Opinion Research weighted response rate for 2021 NEHRS was 45.9%, 2019 NEHRS was 39.0%, and 2018 NEHRS was 34.6%. We intend to maintain the 4-page instrument length, and web and mail data collection modes. As finances allow, we will include tracing for the 2024 and future collections.



  1. Purpose and Use of Information Collection



The purpose of this survey is to collect information on the use of EHR systems, social determinants of health or social needs of patients, interoperability, exchange of patient health information with public health agencies, and use of telemedicine technology, among office-based and outpatient physicians. ONC uses NEHRS data for evaluating progress toward the Health Information Technology for Economic and Clinical Health (HITECH) Act and the 21st Century Cures Act of 2016 program goals related to interoperability. To that end, ONC uses the NEHRS data to update Congress1 on a regular basis on EHR use and interoperability, including barriers to health information exchange and interoperability specifically. ONC also uses the data to provide updates regarding the state of EHR use among to its leadership and stakeholders, sharing findings through data briefs2 and peer-reviewed publications3 in scientific journals. ONC has also shared key findings with HHS agency partners, such as the CDC, Health Resources and Services Administration (HRSA), and Centers for Medicare & Medicaid Services (CMS) on various topics covered by the survey. The Medicare Payment Advisory Commission uses data from NEHRS for a Congressional Report on acceptance of Medicare and Medicaid insurance for new patients.



NEHRS has provided a range of baseline data on the characteristics of United States physicians practicing office-based and outpatient medical care. The proposed NEHRS collections will allow the ability to track the use of EHRs as well as new health information technologies, such as telemedicine technology, across various physician and practice characteristics (e.g., specialty, office type, practice size, and ownership) over time. These data, together with other trend data, may be used to monitor the effects of change in the health care system, provide new insights into office-based and outpatient medical care, and stimulate further research on the use, organization, and delivery of outpatient or office-based medical care. Additionally, NEHRS is uniquely positioned as the only nationally representative survey to have telemedicine technology data before the COVID-19 pandemic. The future NEHRS will add additional datapoints for trend analysis.



NEHRS information is also useful to health planning agencies, managers of health care delivery systems, and others concerned with planning, monitoring, and managing health care resources for health information exchange (HIE), care coordination, safety implications, and the use of health information technology. It is valuable to those who develop and evaluate new and modified health care systems and arrangements. It also provides valuable information about the speed and effectiveness with which certain advances occur in HIE, such as EHR functions, are adopted by the office-based and outpatient physicians.



Users of NEHRS include numerous federal governmental agencies, state and local governments, medical schools, schools of public health, health care industry professionals, colleges and universities, private businesses, non-profit foundations, corporations, and professional associations, as well as individual practitioners, researchers, administrators, and health policymakers. Uses vary from the inclusion of a few selected statistics in a large research effort to an in-depth analysis of the entire NEHRS data set covering multiple years.



  1. Use of Improved information Technology and Burden Reduction



One of the modes of data collection used for NEHRS takes advantage of technology and reduces the burden to respondents: a self-administered web instrument. The contractor for the 2021 NEHRS observed that the average time for respondents to complete the web survey was 9 minutes (23% of respondents); less than half the estimated time of 20 minutes for a respondent to take the self-administered paper instrument (77% of respondents). The burden estimate uses 20 minutes because the majority of responses have been via the self-administered paper instrument. The web instrument is offered first via an United States Postal service letter to all sampled physicians, followed by an email sent to physicians for whom we have an email address. The web instrument incorporates skip patterns and logic checks. The skip patterns use responses to initial survey questions to determine if other survey questions are applicable, allowing a respondent to automatically skip over them if they do not apply. This instrument design feature allows for a reduction in response burden, where applicable. Similarly, logic checks reduce burden and improve data quality by limiting invalid responses. One example of such a logic check is that only the 50 United States and the District of Columbia are available responses for the state of the physician’s office location in the self-administered web instrument.



Since the initial inclusion in 2015, there has been an increase of physician response through the self-administered web instrument. This shows the increased preference for physicians to respond to the survey through the web instrument. As such, as feasible, there will be added emphasis on locating physician email addresses. Tracing and use of these email addresses is projected to increase the number of physician respondents who receive the survey through the web and reduce the number of follow-up contacts among these physicians.



  1. Efforts to Identify Duplication and Use of Similar Information

NCHS and ONC staff have had extensive contacts regarding the NEHRS items with organizations and individuals in both the private and public sectors who are familiar with social determinants of health or social needs, interoperability, and exchange of patient health information with public health agencies. Advice from consultants, attendance at relevant meetings, and literature reviews have been used to identify other sources that collect data on these topics similar to those collected by the NEHRS; however, outside of the NEHRS and the traditional National Ambulatory Medical Care Survey (NAMCS) (OMB No. 0920-0234, Exp. Date 11/30/2025) physician-level data, to date there have been no other sources that would be able to provide annual national estimates. In addition, the 2023 NAMCS is only collecting general information on EHR adoption. Therefore, NEHRS will be the sole source for detailed national data on EHR use.

  1. Impact on Small Businesses or Other Small Entities



A number of NEHRS respondents are physicians in private solo practices or small group practices. In order to reduce the respondent burden for these and all respondents, the survey procedures select only a sample of physicians to be contacted. The sample each year will not overlap with samples used for any NEHRS, NAMCS or NAMCS supplement data collection in the prior two years, and data topics will be kept to the minimum necessary for the survey.



  1. Consequences of Collecting the Information Less Frequently



The consequence of collecting the information less frequently would be that we would not be able to capture the rapidly changing use of health information technology. An annual data collection allows the ability to observe changes from year to year or every two years that can inform decision making, monitor trends, and inform planning necessary for policies.



As noted earlier, ONC uses NEHRS data to monitor progress related to interoperability for its program goals and in its regular report to Congress, and thus this data is needed on a regular basis for this purpose. Additionally, the survey data from NEHRS provides insights to policymakers on areas in need of improvement, based on physicians’ experiences related to barriers to exchange, as well as progress related to interoperability, including capabilities and benefits experienced by physicians. These data are needed on a regular basis to inform Congress, stakeholders and ONC leadership. Furthermore, other trends related to telemedicine and public health reporting hold value beyond ONC; policymakers across HHS, including CDC and CMS. If NEHRS is not collected regularly, it will be difficult to measure trends, the progress of EHR adoption, the overarching goals of the HITECH Act, and the the 21st Century Cures Act related to interoperability, as well as other HHS priorities, including improving response to the pandemic via electronic public health reporting.



  1. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5



This request fully complies with the regulation 5 CFR 1320.5.



  1. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. Federal Register Notice



A 60-day Federal Register Notice was published in the Federal Register on, May 19, 2023, volume 88, page number 32223 (Attachment B). NCHS received two non-substantive comments to the Notice (Attachments B1 and B2) and one substantive comment (Attachment B3). Attachment B4 is NCHS’ response to the substantive comment.



B. Efforts to Consult Outside the Agency



Both ONC and NCHS have worked closely on the development of the questions planned for the 2024 NEHRS and beyond. NCHS will continue to work closely with these outside individuals and agencies as the need for consultation arises. Currently, there are no outstanding unresolved issues. A list containing the names of the consultants is provided in Attachment E.



  1. Explanation of Any Payment of Gift to Respondents

NEHRS will not offer a monetary incentive to respondents for participation. If financially feasible, a non-monetary token will be offered. Non-monetary tokens have been shown to boost physician response rates.4 The decision to use a non-monetary token would be based on available funds. Examples of potential non-monetary items might include a pen, note pad or similar item valued around $2.00 per sampled physician.



  1. Protection of the Privacy and Confidentiality of Information Provided by Respondents



This submission has been reviewed by the Information Collection Review Office (ICRO), who determined that the Privacy Act does apply. The applicable System of Records Notice is 09-20-0167 Health Resources Utilization Statistics. The NCHS Privacy Act Coordinator and the NCHS Confidentiality Officer have also reviewed this package and have determined that the Privacy Act is applicable.

Confidentiality provided to respondents is assured by adherence to Section 308(d) of the Public Health Service Act (42 U.S.C. 242m) which states:

"No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under section...306 (NCHS legislation),...may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose and (1) in the case of information obtained in the course of health statistical or epidemiological activities under section...306, such information may not be published or released in other form if the particular establishment or person supplying the information or described in it is identifiable unless such establishment or person has consented (as determined under regulations of the Secretary) to its publication or release in other form,..."



In addition, legislation covering confidentiality is provided according to the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 3561-3583), which states:



Whoever, being an officer, employee, or agent of an agency acquiring information for exclusively statistical purposes, having taken and subscribed the oath of office, or having sworn to observe the limitations imposed by this section, comes into possession of such information by reason of his or her being an officer, employee, or agent and, knowing that the disclosure of the specific information is prohibited under the provisions of this subchapter, willfully discloses the information in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both.”

Physicians have numerous opportunities to review the details of the NEHRS to decide to participate or decline participation. All letters explain in clear, concise, and straightforward language the basics of the survey, that participation is completely voluntary, and that the physician will not be penalized for nonparticipation. Phone numbers for the survey coordinator and NCHS’ Ethics Review Board (ERB) are also included if the physician or their proxy have any questions or comments about the survey. The physician or proxy can also refuse by mail or phone. By mail, the letter indicates how to respond if the physician chooses not to participate. The physician or proxy can also call to refuse participation via the survey help line. There is also information for survey participants on the NEHRS website.



NEHRS will include a routine set of measures to safeguard confidentiality. First, all staff (including contractors) who have access to confidential information are given instruction by NCHS staff on the requirement to protect the confidentiality, and are required to sign an annual affidavit to maintain confidentiality for life. Second, only authorized personnel are allowed access to confidential records, and only when their work requires it. Third, when confidential information is not in use, it is stored in secure conditions.



In keeping with NCHS policy, if any NEHRS data are made available via public-use data files, all individually identified information, such as physician name, address, and any other specific information, will be removed. Confidential data are never released to the public. All NCHS public data releases are reviewed by the NCHS Disclosure Review Board to avoid data breaches, such as the release of detailed geographic information that may allow anyone to identify practices or physicians in NEHRS.



Information in Identifiable Form (IIF)



NEHRS provides national estimates on provider and practice characteristics. The majority of the data collected is not personally identifiable; however, some are classified as information in identifiable form (IIF). Below is a list of all IIF data items collected in NEHRS. These data items are necessary to properly identify and locate sampled physicians. OMB has approved all of these items previously for the NEHRS Information Collection (OMB No. 0920-1015, Discontinued 11/23/2022). None of these data items are released to the public.



  • Physician name

  • Physician or office mailing address

  • Physician or office telephone number

  • Physician or office email address

  • Physician National Provider Identifier (NPI)



The NPI number is a unique identifier for healthcare providers. This data element will allow for linkage of physician specialty information to other administrative sources of information. Information linking provider identifiers to their characteristics (e.g., specialty, provider age) is also available from CMS for research purposes (https://nppes.cms.hhs.gov/#/).



  1. Institutional Review Board (IRB) and Justification for Sensitive Questions



The NEHRS data collection plan has been approved by NCHS’s ERB (Protocol #2023-01, Attachment F) based on 45 CFR 46. In addition, the ERB has granted a waiver of the documentation of informed consent by physicians.



There are no sensitive questions included within the NEHRS data collection instrument.



  1. Estimates of Annualized Burden Hours and Costs



  1. Burden Hours



The 2024, 2025, and 2026 NEHRS are expected to sample up to 16,633 physicians each year. The the annualized burden hours are calculated based on the assumption that all sampled physicians will respond. While we recognize that, in reality, not all respondents will complete the survey; this method of estimation of the burden for NEHRS is comparable to the approach used by many other surveys conducted by NCHS.



Table 1 below represents estimates for each year of data collection over the approval period (2024-2026). NEHRS will be administered to up to 16,633 physicians each year of the approval period.



Table 1. Estimated Annualized Burden Hours (2024-2026)


Type of Respondent

Form Name


Number of Respondents


Number of

Responses per

Respondent

Average Burden per Response (Hours)

Total Burden

(Hours)

Office-based physicians or office staff

NEHRS

16,633

1

20/60

5,544

Total


16,633



5,544

  1. Burden Cost



The average annual cost for office-based physicians and office staff to participate over the three data collections is estimated to be $505,779.12. The hourly wage estimates for completing the forms mentioned in Table 2 are based on information from the Bureau of Labor Statistics website (http://www.bls.gov). The tables used for this calculation are the “May 2021 National Occupational Employment and Wage Estimates” for (1) health care practitioners and technical occupations, physicians and surgeons, and (2) office administrative and support administrative support occupations. Seventy percent of the total burden hours were attributed to physicians and 30% of the total burden hours were attributed to administrative staff based on information from the 2021 NEHRS data collection. As a result, the hourly wage rate of $91.23 in Table 2 is appropriately allocated hourly wages for physicians and surgeons (i.e., $121.38) and administrative and support staff (i.e., $20.88).



Table 2. Estimated Annualized Respondent Costs

Type of Respondent

Form Name

Total Burden (Hours)

Hourly Wage Rate

Total Respondent Costs

Office-based physicians or office staff

NEHRS

5,544

$91.23

$505,779.12



  1. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers



There will be no annual capital or maintenance costs to the respondent resulting from the collection of information for NEHRS.



  1. Annualized Cost to the Government



The estimate of the average annual cost to the government for the 2024-2026 NEHRS is given below.



Table 3. Annualized Cost to the Government

Cost

Item

$880,931.00

Contract costs for contract staff salaries, data collection, data entry and data processing for NEHRS

$155,734.28

Federal employee salaries

$1,036,665.28

Average total cost for 12 months



  1. Explanation for Program Changes or Adjustments



This is a reinstatement with change. NCHS is requesting 16,633 respondents and 5,544 total burden hours. This data collection will include new content on social determinants of health or social needs, interoperability, and exchange of patient health information with public health agencies. The new content has been asked previously on NEHRS or other survey data collections. The survey will be designed for national level estimates.





  1. Plans for Tabulation and Publication and Project Time Line



Plans for the tabulation and publication and project timeline are provided in Table 4.



Table 4. Project Time Schedule

Activity

Time Schedule

Data collection begins with email or mail letter invitation to web instrument

Spring 2024

Data collection ends

Summer 2024

Analyses

Within 6 months of data release

Publish Web tables, QuickStat or NCHS Data Brief

Within 12 months of data release



NEHRS data must be weighted to produce national estimates about office-based and outpatient physicians and their practices. The weighting process takes place at NCHS after data processing and initial data cleaning. This estimation is accomplished by inflating the responses from each surveyed physician or his/her staff in NEHRS to the national level. For each unit in the sample, a weight is assigned that permits the estimation of physician population totals.



  1. Reason(s) Display of OMB Expiration Date is Inappropriate



The display of the OMB expiration date is not inappropriate.



  1. Exceptions to Certification for Paperwork Reduction Act Submissions



There are no exceptions to the certification.

1 ONC. Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information. https://www.healthit.gov/topic/reports-congress


4 Beatty, P. Jamoom, E.W. “The Effect of Non-Monetary Incentives in a Longitudinal Physician Survey.” AAPOR, Boston, MA, May 17, 2013.

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