[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Notices]
[Pages 43993-43994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19938]


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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.

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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