82 FR 43993 - Notice of Availability of Final Policy Document
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 181 (September 20, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 181 (September 20, 2017)
| Page Range | 43993-43994 | |
| FR Document | 2017-19938 |
[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)] [Notices] [Pages 43993-43994] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19938] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Final Policy Document AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Health Center Program Compliance Manual (Compliance Manual) has been developed as a comprehensive, significantly streamlined, and web-based guidance document to assist health centers in understanding and demonstrating compliance with Health Center Program requirements. As such, this guidance document will reduce burden for current and prospective health centers and look-alikes and further strengthen HRSA's oversight of the Health Center and Health Center Federal Tort Claims Act (FTCA) Programs. It also responds to recommendations contained within the Government Accountability Office report, Health Center Program: Improved Oversight Needed to Ensure Grantee Compliance with Requirements, GAO-12-546, for increased transparency, clarity, and consistency in Health Center Program oversight. The Bureau of Primary Health Care (BPHC) released a draft Compliance Manual on August 23, 2016, for a 90-day public comment period. Individuals and groups submitted over 700 comments regarding the draft Compliance Manual. After thorough review and consideration of all comments received, HRSA made a substantial number of updates to the Compliance Manual to incorporate suggestions and requests for further clarification. HRSA has also posted a summary of comments for each corresponding section and chapter of the Compliance Manual and HRSA's responses to these comments. HRSA's ``Summary of Comments and HRSA Responses on the Draft Health Center Program Compliance Manual'' is available online at https://bphc.hrsa.gov/programrequirements/pdf/healthcentercompliancemanual-comments.pdf. The Compliance Manual, which was effective August 28, 2017, is available online at https://bphc.hrsa.gov/programrequirements/pdf/healthcentercompliancemanual.pdf. All Health Center Program non-regulatory policy issuances that remain in effect after release of the Compliance Manual are listed in Appendix A of the Compliance Manual. With the exception of these policies, the Compliance Manual supersedes other previous Health Center Program non- regulatory policy issuances related to Health Center Program compliance or eligibility requirements. FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, contact HRSA/BPHC at https://www.hrsa.gov/about/contact/bphc.aspx. SUPPLEMENTARY INFORMATION: Executive Orders 12866, 13563 and 13771 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a ``significant regulatory action'' as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as ``economically significant''); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a ``significant'' regulatory action is subject to review by the Office of Management and Budget (OMB). Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. OMB's interim guidance issued on February 2, 2017, explains that for fiscal year 2017 the above requirements only apply to each new ``significant regulatory action that imposes costs.'' It has been determined that the Compliance Manual is not a ``significant regulatory action that imposes costs'' and thus does not trigger the above requirements of Executive Order 12866 or of Executive Order 13771. Background HRSA provides grants to eligible applicants under section 330(e), (g), (h), and/or (i) of the Public Health Service (PHS) Act, as amended (42 U.S.C. 254b), to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. Nearly 1,400 Health Center Program-funded health centers operate approximately 10,400 service delivery sites that provide care to nearly 26 million patients in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. Note that for the purposes of the Compliance Manual, the term ``health center'' refers to entities that receive a federal award under section 330 of the PHS Act, as amended, grant subrecipients, and organizations designated as look-alikes, unless otherwise stated within the Compliance Manual. Look-alikes, as described in Sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social Security Act (42 U.S.C. 1395x(aa)(4)(B) and 42 U.S.C. 1396d(l)(2)(B)(iii)), do not receive a Health Center Program award but must meet the Health Center Program statutory and regulatory requirements. Organizations designated as look-alikes are eligible for payment as a Federally Qualified Health Center under Medicare, Medicaid, and the State Children's Health Insurance Program (CHIP), as well as participation in the 340B Drug Pricing Program and the National Health Service Corps Program. [[Page 43994]] HRSA also makes determinations of deemed PHS employment status for health centers funded under section 330 (including subrecipients), which also extends to certain statutorily eligible ``covered individuals,'' for purposes of providing liability protections under the Health Center Federal Tort Claims Act (FTCA) Program. A favorable FTCA deeming determination requires approval by HRSA of an application submitted by the Health Center Program awardee in the form and manner specified by HRSA. Health centers may also sponsor individual health professional volunteers for such protections. Sections 224(g)-(n) and (q) of the PHS Act (42 U.S.C. 233(g)-(n), and (q)) authorize the Health Center FTCA Program and afford eligibility for FTCA coverage as the exclusive civil remedy for acts or omissions arising within the scope of deemed federal employment in the performance of medical, surgical, dental, or related functions. The Compliance Manual restates the Health Center Program's statutory and regulatory requirements and provides guidance on how health centers would demonstrate compliance with such requirements to HRSA. However, the Compliance Manual also allows health centers to submit alternative means of demonstrating compliance with the specified Health Center Program requirements. All means of demonstrating compliance are subject to HRSA review and approval. Organizations receiving Health Center Program federal awards, including subrecipients, continue to be subject to all requirements incorporated within terms and conditions stated in Notices of Funding Opportunity, Notices of Award, and other applicable laws, regulations, and policies, as well as the distinct statutory, regulatory, and policy requirements of other federal programs in which they participate. Dated: September 13, 2017. George Sigounas, Administrator. [FR Doc. 2017-19938 Filed 9-19-17; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices 43993
Robert Sargis, emanual.pdf. All Health Center Program Executive Order 13771, entitled
Reports Clearance Officer. non-regulatory policy issuances that Reducing Regulation and Controlling
[FR Doc. 2017–20022 Filed 9–19–17; 8:45 am] remain in effect after release of the Regulatory Costs, was issued on January
BILLING CODE 4184–01–P Compliance Manual are listed in 30, 2017. Section 2(a) of Executive
Appendix A of the Compliance Manual. Order 13771 requires an agency, unless
With the exception of these policies, the prohibited by law, to identify at least
DEPARTMENT OF HEALTH AND Compliance Manual supersedes other two existing regulations to be repealed
HUMAN SERVICES previous Health Center Program non- when the agency publicly proposes for
regulatory policy issuances related to notice and comment or otherwise
Health Resources and Services Health Center Program compliance or promulgates a new regulation. In
Administration eligibility requirements. furtherance of this requirement, section
2(c) of Executive Order 13771 requires
Notice of Availability of Final Policy FOR FURTHER INFORMATION CONTACT: For that the new incremental costs
Document questions regarding this notice, contact associated with new regulations shall, to
HRSA/BPHC at https://www.hrsa.gov/ the extent permitted by law, be offset by
AGENCY: Health Resources and Services
about/contact/bphc.aspx. the elimination of existing costs
Administration (HRSA), Department of
Health and Human Services (HHS). SUPPLEMENTARY INFORMATION: associated with at least two prior
ACTION: Notice. regulations. OMB’s interim guidance
Executive Orders 12866, 13563 and issued on February 2, 2017, explains
SUMMARY: The Health Center Program 13771 that for fiscal year 2017 the above
Compliance Manual (Compliance requirements only apply to each new
Executive Orders 12866 and 13563
Manual) has been developed as a ‘‘significant regulatory action that
direct agencies to assess all costs and
comprehensive, significantly imposes costs.’’ It has been determined
benefits of available regulatory
streamlined, and web-based guidance that the Compliance Manual is not a
alternatives and, if regulation is
document to assist health centers in ‘‘significant regulatory action that
necessary, to select regulatory
understanding and demonstrating imposes costs’’ and thus does not trigger
approaches that maximize net benefits
compliance with Health Center Program the above requirements of Executive
(including potential economic,
requirements. As such, this guidance Order 12866 or of Executive Order
environmental, public health and safety
document will reduce burden for 13771.
effects, distributive impacts, and
current and prospective health centers
and look-alikes and further strengthen equity). Executive Order 13563 is Background
HRSA’s oversight of the Health Center supplemental to and reaffirms the HRSA provides grants to eligible
and Health Center Federal Tort Claims principles, structures, and definitions applicants under section 330(e), (g), (h),
Act (FTCA) Programs. It also responds governing regulatory review as and/or (i) of the Public Health Service
to recommendations contained within established in Executive Order 12866, (PHS) Act, as amended (42 U.S.C. 254b),
the Government Accountability Office emphasizing the importance of to support the delivery of preventive
report, Health Center Program: quantifying both costs and benefits, of and primary care services to medically
Improved Oversight Needed to Ensure reducing costs, of harmonizing rules, underserved communities and
Grantee Compliance with Requirements, and of promoting flexibility. Section 3(f) vulnerable populations. Nearly 1,400
GAO–12–546, for increased of Executive Order 12866 defines a Health Center Program-funded health
transparency, clarity, and consistency in ‘‘significant regulatory action’’ as an centers operate approximately 10,400
Health Center Program oversight. action that is likely to result in a rule: service delivery sites that provide care
The Bureau of Primary Health Care (1) Having an annual effect on the to nearly 26 million patients in every
(BPHC) released a draft Compliance economy of $100 million or more in any U.S. state, the District of Columbia,
Manual on August 23, 2016, for a 90-day 1 year, or adversely and materially Puerto Rico, the U.S. Virgin Islands, and
public comment period. Individuals and affecting a sector of the economy, the Pacific Basin. Note that for the
groups submitted over 700 comments productivity, competition, jobs, the purposes of the Compliance Manual, the
regarding the draft Compliance Manual. environment, public health or safety, or term ‘‘health center’’ refers to entities
After thorough review and State, local, or Tribal governments or that receive a federal award under
consideration of all comments received, communities (also referred to as section 330 of the PHS Act, as amended,
HRSA made a substantial number of ‘‘economically significant’’); (2) creating grant subrecipients, and organizations
updates to the Compliance Manual to a serious inconsistency or otherwise designated as look-alikes, unless
incorporate suggestions and requests for interfering with an action taken or otherwise stated within the Compliance
further clarification. HRSA has also planned by another agency; (3) Manual. Look-alikes, as described in
posted a summary of comments for each materially altering the budgetary Sections 1861(aa)(4)(B) and 1905(l)(2)(B)
corresponding section and chapter of impacts of entitlement grants, user fees, of the Social Security Act (42 U.S.C.
the Compliance Manual and HRSA’s or loan programs or the rights and 1395x(aa)(4)(B) and 42 U.S.C.
responses to these comments. HRSA’s obligations of recipients thereof; or (4) 1396d(l)(2)(B)(iii)), do not receive a
‘‘Summary of Comments and HRSA raising novel legal or policy issues Health Center Program award but must
Responses on the Draft Health Center arising out of legal mandates, the meet the Health Center Program
Program Compliance Manual’’ is President’s priorities, or the principles statutory and regulatory requirements.
available online at https:// set forth in the Executive Order. A Organizations designated as look-alikes
sradovich on DSKBBY8HB2PROD with NOTICES
bphc.hrsa.gov/programrequirements/ regulatory impact analysis (RIA) must are eligible for payment as a Federally
pdf/healthcentercompliancemanual- be prepared for major rules with Qualified Health Center under
comments.pdf. The Compliance economically significant effects ($100 Medicare, Medicaid, and the State
Manual, which was effective August 28, million or more in any 1 year), and a Children’s Health Insurance Program
2017, is available online at https:// ‘‘significant’’ regulatory action is subject (CHIP), as well as participation in the
bphc.hrsa.gov/programrequirements/ to review by the Office of Management 340B Drug Pricing Program and the
pdf/healthcentercomplianc and Budget (OMB). National Health Service Corps Program.
VerDate Sep<11>2014 18:28 Sep 19, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1](https://thefederalregister.org/doc/82_FR_44174/page/1.svg)
![43994 Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices
HRSA also makes determinations of DEPARTMENT OF HOMELAND notice. It is not for individual case
deemed PHS employment status for SECURITY status inquiries. Applicants seeking
health centers funded under section 330 information about the status of their
(including subrecipients), which also U.S. Citizenship and Immigration individual cases can check Case Status
extends to certain statutorily eligible Services Online, available at the USCIS Web site
‘‘covered individuals,’’ for purposes of [OMB Control Number 1615–0121] at http://www.uscis.gov, or call the
providing liability protections under the USCIS National Customer Service
Health Center Federal Tort Claims Act Agency Information Collection Center at 800–375–5283 (TTY 800–767–
(FTCA) Program. A favorable FTCA Activities; Extension, Without Change, 1833).
deeming determination requires of a Currently Approved Collection:
SUPPLEMENTARY INFORMATION:
approval by HRSA of an application Generic Clearance for the Collection of
submitted by the Health Center Program Qualitative Feedback on Agency Comments
awardee in the form and manner Service Delivery
You may access the information
specified by HRSA. Health centers may AGENCY: U.S. Citizenship and collection instrument with instructions,
also sponsor individual health Immigration Services, Department of or additional information by visiting the
professional volunteers for such Homeland Security. Federal eRulemaking Portal site at:
protections. Sections 224(g)–(n) and (q) ACTION: 60-Day notice. http://www.regulations.gov and enter
of the PHS Act (42 U.S.C. 233(g)–(n), USCIS–2014–0008 in the search box.
and (q)) authorize the Health Center SUMMARY: The Department of Homeland
Regardless of the method used for
FTCA Program and afford eligibility for Security (DHS), U.S. Citizenship and
submitting comments or material, all
FTCA coverage as the exclusive civil Immigration (USCIS) invites the general
submissions will be posted, without
remedy for acts or omissions arising public and other Federal agencies to
change, to the Federal eRulemaking
within the scope of deemed federal comment upon this proposed extension
Portal at http://www.regulations.gov,
employment in the performance of of a currently approved collection of
information or new collection of and will include any personal
medical, surgical, dental, or related information you provide. Therefore,
functions. information. In accordance with the
Paperwork Reduction Act (PRA) of submitting this information makes it
The Compliance Manual restates the 1995, the information collection notice public. You may wish to consider
Health Center Program’s statutory and is published in the Federal Register to limiting the amount of personal
regulatory requirements and provides obtain comments regarding the nature of information that you provide in any
guidance on how health centers would the information collection, the voluntary submission you make to DHS.
demonstrate compliance with such categories of respondents, the estimated DHS may withhold information
requirements to HRSA. However, the burden (i.e. the time, effort, and provided in comments from public
Compliance Manual also allows health resources used by the respondents to viewing that it determines may impact
centers to submit alternative means of respond), the estimated cost to the the privacy of an individual or is
demonstrating compliance with the respondent, and the actual information offensive. For additional information,
specified Health Center Program collection instruments. please read the Privacy Act notice that
requirements. All means of is available via the link in the footer of
DATES: Comments are encouraged and
demonstrating compliance are subject to http://www.regulations.gov.
will be accepted for 60 days until
HRSA review and approval. November 20, 2017. Written comments and suggestions
Organizations receiving Health Center ADDRESSES: All submissions received from the public and affected agencies
must include the OMB Control Number should address one or more of the
Program federal awards, including
1615–0121 in the body of the letter, the following four points:
subrecipients, continue to be subject to
all requirements incorporated within agency name and Docket ID USCIS– (1) Evaluate whether the proposed
terms and conditions stated in Notices 2014–0008. To avoid duplicate collection of information is necessary
of Funding Opportunity, Notices of submissions, please use only one of the for the proper performance of the
Award, and other applicable laws, following methods to submit comments: functions of the agency, including
regulations, and policies, as well as the (1) Online. Submit comments via the whether the information will have
distinct statutory, regulatory, and policy Federal eRulemaking Portal Web site at practical utility;
http://www.regulations.gov under e- (2) Evaluate the accuracy of the
requirements of other federal programs
Docket ID number USCIS–2014–0008; agency’s estimate of the burden of the
in which they participate.
(2) Mail. Submit written comments to proposed collection of information,
Dated: September 13, 2017. DHS, USCIS, Office of Policy and including the validity of the
George Sigounas, Strategy, Chief, Regulatory Coordination
methodology and assumptions used;
Administrator. Division, 20 Massachusetts Avenue
NW., Washington, DC 20529–2140. (3) Enhance the quality, utility, and
[FR Doc. 2017–19938 Filed 9–19–17; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
clarity of the information to be
BILLING CODE 4165–15–P collected; and
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division, (4) Minimize the burden of the
Samantha Deshommes, Chief, 20 collection of information on those who
sradovich on DSKBBY8HB2PROD with NOTICES
Massachusetts Avenue NW., are to respond, including through the
Washington, DC 20529–2140, telephone use of appropriate automated,
number 202–272–8377 (This is not a electronic, mechanical, or other
toll-free number. Comments are not technological collection techniques or
accepted via telephone message). Please other forms of information technology,
note contact information provided here e.g., permitting electronic submission of
is solely for questions regarding this responses.
VerDate Sep<11>2014 18:28 Sep 19, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1](https://thefederalregister.org/doc/82_FR_44174/page/2.svg)
Document Created: 2018-10-24 14:22:48
Document Modified: 2018-10-24 14:22:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | For questions regarding this notice, contact HRSA/BPHC at https://www.hrsa.gov/about/contact/bphc.aspx. | |
| FR Citation | 82 FR 43993 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR