[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61224-61225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Request for Public Comment on Draft Health Center Program 
Compliance Manual

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Request for public comment on Draft Health Center Program 
Compliance Manual.

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SUMMARY: HRSA is inviting public comment on the Draft Health Center 
Program Compliance Manual, hereafter referred to as the Compliance 
Manual. The purpose of the Compliance Manual is to provide a 
consolidated web-based resource to assist current and prospective 
health centers in understanding and demonstrating compliance with 
requirements of the Health Center Program, a HRSA-administered program 
authorized under 42 U.S.C. 254b. The Compliance Manual identifies 
requirements found in the Health Center Program's authorizing 
legislation and implementing regulations, as well as certain applicable 
grant regulations. The Compliance Manual also addresses HRSA's approach 
to determining eligibility for and oversight of the Health Center 
Program. In addition, the Compliance Manual includes the requirements 
for obtaining deemed Public Health Service (PHS) employee status under 
the Federally Supported Health Centers Assistance Acts of 1992 and 
1995, for purposes of Federal Tort Claims Act (FTCA) liability 
protections for the performance of medical, surgical, dental, and 
related functions within the scope of deemed PHS employment.

DATES: Submit written comments no later than November 22, 2016.

ADDRESSES: Written comments should be submitted through the HRSA/Bureau 
of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/programrequirements/draftcompliancemanual/index.html.

FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, 
contact HRSA/BPHC/Office of Policy and Program Development at 
[email protected].

SUPPLEMENTARY INFORMATION: HRSA provides grants to eligible applicants 
under section 330(e), (g), (h), and/or (i) of the 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 9,800 service delivery sites that provide care to 
over 24 million patients in every U.S. state, the District of Columbia, 
Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. HRSA also 
designates eligible applicants under the Health Center Look-Alike 
Program (see Sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social 
Security Act). Look-Alikes do not receive Health Center Program funding 
but must meet the Health Center Program statutory and regulatory 
requirements. 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, subrecipients, and 
organizations designated as look-alikes, unless otherwise stated.
    HRSA also makes determinations of deemed PHS employment status for 
health centers funded under section 330 and their covered individuals 
for purposes of providing liability protections under the Health Center 
Federal Tort Claims Act (FTCA) Program. Section 224(g)-(n) of the PHS 
Act (42 U.S.C. 233(g)-(n)) authorizes the FTCA Program and affords 
eligibility for FTCA coverage as the exclusive civil remedy for acts or 
omissions arising from the performance of medical, surgical, dental, or 
related functions within the scope of such employment by deemed health 
centers and by any officers, governing board members, employees, and 
certain individual contractors of these entities. A favorable FTCA 
deeming determination requires submission of an application by the 
Health Center Program awardee in the form and manner specified by HRSA.
    The Compliance Manual includes sections identifying the 
requirements found in the Health Center Program's authorizing 
legislation and program implementing regulations (section 330 of the 
PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56); certain 
applicable HHS grant regulations (45 CFR part 75); and the Health 
Center FTCA Program's authorizing legislation and implementing 
regulations (section 224(g)-(n) of the PHS Act, and 42 CFR part 6). 
Organizations receiving Health Center Program federal awards, including 
subrecipients, are also subject to all requirements incorporated within 
documents such as Funding Opportunity Announcements and Notices of 
Award. The Compliance Manual specifies Health Center Program non-
regulatory policy issuances that would be superseded, as well as those 
that would remain in effect.
    The first chapter of the Compliance Manual outlines HRSA's approach 
to determining organizational eligibility for the Health Center 
Program, including how to demonstrate non-profit or public agency 
status. The chapter also describes organizational eligibility 
requirements that apply only to look-alikes. The second chapter 
clarifies HRSA/BPHC's oversight process by providing information on how 
HRSA will address areas of noncompliance and impose enforcement 
actions, including those for serious violations that may lead to the 
suspension of grant activities or termination of grant funding by HRSA 
under 45 CFR part 75.
    The Compliance Manual contains 18 chapters on Health Center Program 
requirements, each of which: (a) Cites the applicable statutory and 
regulatory authorities; (b) lists statutory and regulatory 
requirements; (c) describes how health centers would demonstrate 
compliance to HRSA; and d) includes examples of areas in which health 
centers have discretion or that may be helpful for health centers to 
consider when implementing the requirements.
    The final chapter specifies the FTCA requirements for obtaining 
deemed PHS employment status, including how a health center would 
demonstrate compliance with the FTCA requirements in its annual deeming 
application. Please note that deemed employment status does not confer 
FTCA coverage in all cases, as health center providers also must comply 
with applicable legal eligibility requirements and covered actions must 
be undertaken within the scope of such deemed PHS employment (for more 
information, see the Federal Tort Claims Act Health Center Policy 
Manual at http://

[[Page 61225]]

bphc.hrsa.gov/ftca/healthcenters/ftcahcpolicymanual.html). When FTCA 
matters become the subject of litigation, the U.S. Department of 
Justice and the federal courts may assume significant roles in 
certifying or determining whether or not a given activity falls within 
the scope of employment, for purposes of FTCA coverage.

    Dated: August 30, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-21321 Filed 9-2-16; 8:45 am]
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