81 FR 61224 - Request for Public Comment on Draft Health Center Program Compliance Manual
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 172 (September 6, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 172 (September 6, 2016)
| Page Range | 61224-61225 | |
| FR Document | 2016-21321 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Notices] [Pages 61224-61225] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21321] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 4165-15-P
![61224 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Senior Executive Service members for dental, and related functions within the The Compliance Manual includes
the Fiscal Year 2016 review period: scope of deemed PHS employment. sections identifying the requirements
Leslie Atkinson, Tonya Bowers, DATES: Submit written comments no found in the Health Center Program’s
Adriane Burton, Tina Cheatham, Laura later than November 22, 2016. authorizing legislation and program
Cheever, Cheryl Dammons, Elizabeth ADDRESSES: Written comments should implementing regulations (section 330
DeVoss, Diana Espinosa, Catherine be submitted through the HRSA/Bureau of the PHS Act, as amended, 42 CFR
Ganey, Alexandra Garcia, Richard of Primary Health Care (BPHC) Web site part 51c, and 42 CFR part 56); certain
Goodman, Heather Hauck, Avril at http://bphc.hrsa.gov/ applicable HHS grant regulations (45
Houston, Laura Kavanagh, Martin programrequirements/ CFR part 75); and the Health Center
Kramer, Sarah Linde, Rimas Liogys, draftcompliancemanual/index.html. FTCA Program’s authorizing legislation
Michael Lu, Dennis Malcomson, James FOR FURTHER INFORMATION CONTACT: For
and implementing regulations (section
Macrae, Thomas Morris, Kerry Nesseler, questions regarding this notice, contact 224(g)–(n) of the PHS Act, and 42 CFR
William O’Rourke, Luis Padilla, HRSA/BPHC/Office of Policy and part 6). Organizations receiving Health
Deborah Parham Hopson, Wendy Program Development at Center Program federal awards,
Ponton, Patricia Stroup. HCPComplianceManual@hrsa.gov. including subrecipients, are also subject
Dated: August 30, 2016. to all requirements incorporated within
SUPPLEMENTARY INFORMATION: HRSA
James Macrae,
documents such as Funding
provides grants to eligible applicants
Opportunity Announcements and
Acting Administrator. under section 330(e), (g), (h), and/or (i)
Notices of Award. The Compliance
[FR Doc. 2016–21320 Filed 9–2–16; 8:45 am] of the PHS Act, as amended (42 U.S.C.
Manual specifies Health Center Program
BILLING CODE 4165–15–P 254b), to support the delivery of
non-regulatory policy issuances that
preventive and primary care services to
would be superseded, as well as those
medically underserved communities
that would remain in effect.
DEPARTMENT OF HEALTH AND and vulnerable populations. Nearly The first chapter of the Compliance
HUMAN SERVICES 1,400 Health Center Program-funded Manual outlines HRSA’s approach to
health centers operate approximately determining organizational eligibility
Health Resources and Services 9,800 service delivery sites that provide for the Health Center Program,
Administration care to over 24 million patients in every including how to demonstrate non-
U.S. state, the District of Columbia, profit or public agency status. The
Request for Public Comment on Draft Puerto Rico, the U.S. Virgin Islands, and
Health Center Program Compliance chapter also describes organizational
the Pacific Basin. HRSA also designates eligibility requirements that apply only
Manual eligible applicants under the Health to look-alikes. The second chapter
AGENCY: Health Resources and Services Center Look-Alike Program (see clarifies HRSA/BPHC’s oversight
Administration (HRSA), Department of Sections 1861(aa)(4)(B) and 1905(l)(2)(B) process by providing information on
Health and Human Services (HHS). of the Social Security Act). Look-Alikes how HRSA will address areas of
ACTION: Request for public comment on do not receive Health Center Program noncompliance and impose
Draft Health Center Program funding but must meet the Health enforcement actions, including those for
Compliance Manual. Center Program statutory and regulatory serious violations that may lead to the
requirements. Note that for the purposes suspension of grant activities or
SUMMARY: HRSA is inviting public of the Compliance Manual, the term termination of grant funding by HRSA
comment on the Draft Health Center ‘‘health center’’ refers to entities that under 45 CFR part 75.
Program Compliance Manual, hereafter receive a federal award under section The Compliance Manual contains 18
referred to as the Compliance Manual. 330 of the PHS Act, as amended, chapters on Health Center Program
The purpose of the Compliance Manual subrecipients, and organizations requirements, each of which: (a) Cites
is to provide a consolidated web-based designated as look-alikes, unless the applicable statutory and regulatory
resource to assist current and otherwise stated. authorities; (b) lists statutory and
prospective health centers in HRSA also makes determinations of regulatory requirements; (c) describes
understanding and demonstrating deemed PHS employment status for how health centers would demonstrate
compliance with requirements of the health centers funded under section 330 compliance to HRSA; and d) includes
Health Center Program, a HRSA- and their covered individuals for examples of areas in which health
administered program authorized under purposes of providing liability centers have discretion or that may be
42 U.S.C. 254b. The Compliance Manual protections under the Health Center helpful for health centers to consider
identifies requirements found in the Federal Tort Claims Act (FTCA) when implementing the requirements.
Health Center Program’s authorizing Program. Section 224(g)–(n) of the PHS The final chapter specifies the FTCA
legislation and implementing Act (42 U.S.C. 233(g)–(n)) authorizes the requirements for obtaining deemed PHS
regulations, as well as certain applicable FTCA Program and affords eligibility for employment status, including how a
grant regulations. The Compliance FTCA coverage as the exclusive civil health center would demonstrate
Manual also addresses HRSA’s remedy for acts or omissions arising compliance with the FTCA
approach to determining eligibility for from the performance of medical, requirements in its annual deeming
and oversight of the Health Center surgical, dental, or related functions application. Please note that deemed
Program. In addition, the Compliance within the scope of such employment employment status does not confer
Manual includes the requirements for by deemed health centers and by any FTCA coverage in all cases, as health
mstockstill on DSK3G9T082PROD with NOTICES
obtaining deemed Public Health Service officers, governing board members, center providers also must comply with
(PHS) employee status under the employees, and certain individual applicable legal eligibility requirements
Federally Supported Health Centers contractors of these entities. A favorable and covered actions must be undertaken
Assistance Acts of 1992 and 1995, for FTCA deeming determination requires within the scope of such deemed PHS
purposes of Federal Tort Claims Act submission of an application by the employment (for more information, see
(FTCA) liability protections for the Health Center Program awardee in the the Federal Tort Claims Act Health
performance of medical, surgical, form and manner specified by HRSA. Center Policy Manual at http://
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![Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61225
bphc.hrsa.gov/ftca/healthcenters/ Name of Committee: Center for Scientific Name of Committee: National Heart, Lung,
ftcahcpolicymanual.html). When FTCA Review Special Emphasis Panel; Member and Blood Institute Special Emphasis Panel;
matters become the subject of litigation, Conflict: Alcohol and Motivated Behavior. SBIR Direct Phase II, Bioreactors for
the U.S. Department of Justice and the Date: October 5–6, 2016. Reparative Medicine.
Time: 8:00 a.m. to 6:00 p.m. Date: September 28, 2016.
federal courts may assume significant Agenda: To review and evaluate grant Time: 1:00 p.m. to 1:30 p.m.
roles in certifying or determining applications. Agenda: To review and evaluate grant
whether or not a given activity falls Place: National Institutes of Health, 6701 applications.
within the scope of employment, for Rockledge Drive, Bethesda, MD 20892, Place: Residence Inn Bethesda, 7335
purposes of FTCA coverage. (Virtual Meeting). Wisconsin Avenue, Bethesda, MD 20814.
Dated: August 30, 2016. Contact Person: Michael Selmanoff, Ph.D., Contact Person: Tony L. Creazzo, Ph.D.,
Scientific Review Officer, Center for Scientific Review Officer, Office of Scientific
James Macrae, Review/DERA, National Heart, Lung, and
Scientific Review, National Institutes of
Acting Administrator. Health, 6701 Rockledge Drive, Room 5164, Blood Institute, 6701 Rockledge Drive, Room
[FR Doc. 2016–21321 Filed 9–2–16; 8:45 am] MSC 7844, Bethesda, MD 20892, 301–435– 7180, Bethesda, MD 20892–7924, 301–435–
BILLING CODE 4165–15–P 1119, selmanom@csr.nih.gov. 0725, creazzotl@mail.nih.gov.
Name of Committee: Molecular, Cellular Name of Committee: National Heart, Lung,
and Developmental Neuroscience Integrated and Blood Institute Special Emphasis Panel;
DEPARTMENT OF HEALTH AND Review Group; Biophysics of Neural Systems Phase I and Phase II, Bioreactors for
HUMAN SERVICES Study Section. Reparative Medicine (SBIR).
Date: October 5, 2016. Date: September 28, 2016.
National Institutes of Health Time: 8:00 a.m. to 7:00 p.m. Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant Agenda: To review and evaluate grant
Center for Scientific Review; Notice of applications. applications.
Closed Meetings Place: Hotel Monaco Baltimore, 2 North Place: Residence Inn Bethesda, 7335
Charles Street, Baltimore, MD 212013. Wisconsin Avenue, Bethesda, MD 20814.
Pursuant to section 10(d) of the Contact Person: Geoffrey G Schofield, Contact Person: Tony L. Creazzo, Ph.D.,
Federal Advisory Committee Act, as Ph.D., Scientific Review Officer, Center for Scientific Review Officer, Office of Scientific
amended (5 U.S.C. App.), notice is Scientific Review, National Institutes of Review/DERA, National Heart, Lung, and
hereby given of the following meetings. Health, 6701 Rockledge Drive, Room 4040–A, Blood Institute, 6701 Rockledge Drive, Room
MSC 7850, Bethesda, MD 20892, 301–435– 7180, Bethesda, MD 20892–7924, 301–435–
The meetings will be closed to the public 1235, geoffreys@csr.nih.gov. 0725, creazzotl@mail.nih.gov.
in accordance with the provisions set forth in Name of Committee: National Heart, Lung,
sections 552b(c)(4) and 552b(c)(6), title 5 (Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine; and Blood Institute Special Emphasis Panel;
U.S.C., as amended. The grant applications Phase I and Phase II, Bioreactors for
and thediscussions could disclose 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844, Reparative Medicine (STTR).
confidential trade secrets or commercial Date: September 28, 2016.
property such as patentable material, and 93.846-93.878, 93.892, 93.893, National
Institutes of Health, HHS) Time: 12:30 p.m. to 1:00 p.m.
personal information concerning individuals Agenda: To review and evaluate grant
associated with the grant applications, the Dated: August 30, 2016. applications.
disclosure of which would constitute a Natasha M. Copeland, Place: Residence Inn Bethesda, 7335
clearly unwarranted invasion of personal Wisconsin Avenue, Bethesda, MD 20814.
privacy. Program Analyst, Office of Federal Advisory
Committee Policy. Contact Person: Tony L. Creazzo, Ph.D.,
Name of Committee: Musculoskeletal, Oral Scientific Review Officer, Office of Scientific
[FR Doc. 2016–21232 Filed 9–2–16; 8:45 am]
and Skin Sciences Integrated Review Group; Review/DERA, National Heart, Lung, and
BILLING CODE 4140–01–P Blood Institute, 6701 Rockledge Drive, Room
Skeletal Biology Development and Disease
Study Section. 7180, Bethesda, MD 20892–7924, 301–435–
Date: September 28–29, 2016. 0725, creazzotl@mail.nih.gov.
Time: 7:30 a.m. to 5:00 p.m. DEPARTMENT OF HEALTH AND
(Catalogue of Federal Domestic Assistance
Agenda: To review and evaluate grant HUMAN SERVICES Program Nos. 93.233, National Center for
applications. Sleep Disorders Research; 93.837, Heart and
Place: Holiday Inn San Francisco National Institutes of Health Vascular Diseases Research; 93.838, Lung
Fisherman’s Wharf, 1300 Columbus Avenue, Diseases Research; 93.839, Blood Diseases
San Francisco, CA 94133. National Heart, Lung, and Blood and Resources Research, National Institutes
Contact Person: Aruna K Behera, Ph.D., Institute Notice of Closed Meetings of Health, HHS)
Scientific Review Officer, Center for
Scientific Review, National Institutes of Pursuant to section 10(d) of the Dated: August 30, 2016.
Health, 6701 Rockledge Drive, Room 4211, Federal Advisory Committee Act, as Michelle Trout,
MSC 7814, Bethesda, MD 20892, 301–435– amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory
6809, beheraak@csr.nih.gov. hereby given of the following meetings. Committee Policy.
Name of Committee: Infectious Diseases [FR Doc. 2016–21233 Filed 9–2–16; 8:45 am]
and Microbiology Integrated Review Group; The meetings will be closed to the
public in accordance with the BILLING CODE 4140–01–P
Vector Biology Study Section.
Date: October 5, 2016. provisions set forth in sections
Time: 8:00 a.m. to 6:00 p.m. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND
as amended. The grant applications and
applications. HUMAN SERVICES
the discussions could disclose
mstockstill on DSK3G9T082PROD with NOTICES
Place: Cambria Suites Rockville, 1 Helen confidential trade secrets or commercial
Heneghan Way, Rockville, MD 20850. National Institutes of Health
property such as patentable material,
Contact Person: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
and personal information concerning National Institute on Aging; Notice of
Scientific Review, National Institutes of individuals associated with the grant Closed Meeting
Health, 6701 Rockledge Drive, Room 3214, applications, the disclosure of which
MSC 7808, Bethesda, MD 20892, 301–402– would constitute a clearly unwarranted Pursuant to section 10(d) of the
5671, zhengli@csr.nih.gov. invasion of personal privacy. Federal Advisory Committee Act, as
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Document Created: 2018-02-09 12:04:16
Document Modified: 2018-02-09 12:04:16
| 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 | Request for public comment on Draft Health Center Program Compliance Manual. | |
| Dates | Submit written comments no later than November 22, 2016. | |
| Contact | For questions regarding this notice, contact HRSA/BPHC/Office of Policy and Program Development at [email protected] | |
| FR Citation | 81 FR 61224 |
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