[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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