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Introduction

In this chapter:

Applicability

This Health Center Program Compliance Manual (“Compliance Manual”) applies to all health centers that apply for1 or receive Federal award funds under the Health Center Program authorized by section 330 of the Public Health Service (PHS) Act (42 U.S.C. 254b) (“section 330”), as amended (including sections 330(e), (g), (h), and (i)), as well as subrecipient organizations2 and Health Center Program look-alikes. Look-alikes do not receive Federal funding under section 330 of the PHS Act; however, to receive look-alike designation and associated Federal benefits, look-alikes must meet the Health Center Program requirements.3 For the purposes of this document, the term “health center” refers to entities that apply for or receive a Federal award under section 330 of the PHS Act (including section 330 (e), (g), (h) and (i)), section 330 subrecipients, and organizations designated as look-alikes.

This Compliance Manual does not apply to activities conducted outside of a health center’s Health Resources and Services Administration (HRSA)-approved scope of project.4

Purpose

The purpose of the Compliance Manual is to provide a consolidated resource to assist health centers in understanding and demonstrating compliance with Health Center Program requirements. The Compliance Manual also addresses HRSA’s approach to determining eligibility for and exercising oversight over the Health Center Program and details the requirements for obtaining deemed PHS employee status under section 224 (g)-(n) and (q) of the PHS Act.5

The Compliance Manual identifies requirements found in the Health Center Program’s authorizing legislation and implementing regulations, as well as certain applicable grants regulations.6 These requirements form the foundation of the Health Center Program and support the core mission of this innovative and successful model of primary care. The Compliance Manual does not provide guidance on requirements in areas beyond Health Center Program requirements or outside HRSA’s oversight authority. In addition, the Compliance Manual is not intended to address best or promising practices or performance improvement strategies that may support effective operations or organizational excellence.

Health Center Program non-regulatory policy issuances that remain in effect after release of the Compliance Manual are listed in Appendix A. With the exception of these policies, the Compliance Manual supersedes other previous Health Center Program non-regulatory policy issuances (Policy Information Notices (PINs), Program Assistance Letters (PALs), Regional Office Memoranda, Regional Program Guidance memoranda, and other non-regulatory materials) related to Health Center Program compliance or eligibility requirements. In case of any conflict between a provision of the Compliance Manual and other HRSA-disseminated non-regulatory materials related to compliance and/or eligibility requirements, the provisions of the Compliance Manual control. Previously published issuances that are superseded by this Manual include, but are not limited to:

  • PIN 1994-07: Migrant Voucher Program Guidance
  • PINs 1997-27 and 1998-24: Affiliation Agreements of Community & Migrant Health Centers and Amendment to PIN 1997-27 Regarding Affiliation Agreements of Community and Migrant Health Centers
  • PINs 2001-16 and 2002-22: Credentialing and Privileging of Health Center Practitioners and Clarification of BPHC Credentialing & Privileging Policy Outlined in PIN 2001-16
  • PAL 2006-01: Dual Status-Health Centers that are both FQHC Look-Alikes and Section 330 Grantees
  • PIN 2010-01: Confirming Public Agency Status under the Health Center Program and FQHC Look-Alike Program
  • PIN 2013-01: Health Center Program Budgeting and Accounting Requirements
  • PIN 2014-01: Health Center Program Governance
  • PIN 2014-02: Sliding Fee Discount and Related Billing and Collections Program Requirements
  • PAL 2014-08: Health Center Program Requirements Oversight7
  • PAL 2014-11: Applicability of PAL 2014-08: Health Center Program Requirements Oversight to Look-Alikes

The Compliance Manual serves as the foundation for HRSA’s eligibility and compliance-related determinations and for HRSA’s review processes for the Health Center Program. HRSA will update or amend the Compliance Manual as needed to provide further policy clarification with respect to demonstrating compliance with Health Center Program requirements.

Structure of the Health Center Program Compliance Manual

Chapters in the Compliance Manual are generally organized as follows:

  • Authority: Lists the applicable statutory and regulatory citations.8
  • Requirements: States the statutory and regulatory requirements.

  • Demonstrating Compliance: Describes how health centers would demonstrate to HRSA their compliance with the Requirements by fulfilling all elements in this section.

    Note: Health centers that fail to demonstrate compliance as described in this Manual will receive a condition of award/designation. In responding to such conditions, health centers could demonstrate their compliance to HRSA either by submitting documentation as described in the Demonstrating Compliance sections of the Manual or by the health center proposing an alternative means of demonstrating compliance with the specified Requirements, which would include submitting an explanation and documentation that explicitly demonstrate compliance. All responses to conditions are subject to review and approval by HRSA (see Chapter 2: Health Center Program Oversight).

  • Related Considerations: Describes areas where health centers have discretion with respect to decision-making or that may be useful for health centers to consider when implementing a requirement. When specific examples are provided, they are not intended to be an all-inclusive list. All related considerations are offered with the understanding that health center decision-making and implementation are consistent with all applicable statutory, regulatory, and policy requirements.

Additional Health Center Responsibilities

In addition to the requirements included in this Compliance Manual, organizations receiving Health Center Program Federal awards, including subrecipients, are also subject to other applicable award-related statutory, regulatory, and policy requirements (see 45 CFR Part 75 and the U.S. Department of Health and Human Services (HHS) Grants Policy Statement (GPS),9 Notices of Funding Opportunity (NOFOs),10 and Notices of Award (NoAs)). As such, the Compliance Manual does not constitute an exhaustive listing of all requirements that may be included in terms and conditions stated in NOFOs, NoAs, and other applicable laws, regulations, and policies.

Health centers (including look-alikes) are subject to the distinct statutory, regulatory, and policy requirements of other Federal programs that they may be eligible for and participate in as a result of the Health Center Program award or designation, such as:

  • Federally Qualified Health Center (FQHC) status, payment rates, and requirements under Titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act;11
  • The 340B Drug Pricing Program;12
  • The National Health Service Corps (NHSC) Program; and
  • The Health Center FTCA Medical Malpractice Program (with the exception of the deeming requirements included in the Compliance Manual).13

Each health center is responsible for maintaining its operations, including developing and implementing its own operating procedures, in compliance with all Health Center Program requirements and all other applicable Federal, state, and local laws and regulations.14 This includes but is not limited to those protecting public welfare, the environment and prohibiting discrimination; state facility and licensing laws; state scope of practice laws; Centers for Medicare and Medicaid Services (CMS) Conditions for Coverage for FQHCs;15 and State Medicaid requirements. In fulfilling all of these oversight and compliance responsibilities, a health center may wish to consult its private legal counsel. Health centers may also direct questions to the designated points of contact for these programs.

Footnotes

1. Notices of Funding Opportunity (NOFOs) may include specified timelines for new awardees to demonstrate compliance with the requirements specified in this Manual following receipt of the Federal Health Center Program award.

2. 42 U.S.C. 1395x(aa)(4)(A)(ii) and 42 U.S.C. 1396d(l)(2)(B)(ii).

3. 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)).

4. See Scope of Project website for more information on scope of project.

5. Health Center FTCA Medical Malpractice Program procedures and information, as set forth in the FTCA Health Center Policy Manual (PDF - 406 KB), are not superseded by this Manual. See Appendix A for additional policy issuances which remain in effect.

6. Section 330 of the PHS Act (42 U.S.C. §254b), as amended, 42 CFR Part 51c and 42 CFR Part 56 for Community and Migrant Health Centers, respectively, and 45 CFR Part 75.

7. PAL 2014-08 superseded PAL 2010-01, “Enhancements to Support Health Center Program Requirements Monitoring,” which was issued April 8, 2010.

8. These citations include requirements under the Uniform Administrative Requirements for all HHS awards (45 CFR Part 75) which are applicable to organizations receiving Federal funding under the Health Center Program (45 C.F.R. 75.101).

9. Further grants policy information may be found in the HHS Grants Policy Statement and the HRSA SF-424 Application Guide. See HRSA Grants website for more information.

10. Individual NOFOs may contain specific additional terms and conditions of award beyond those identified in this Manual.

11. 42 U.S.C. 1396a(a)(15) and 42 U.S.C. 1396(a)(bb); and 42 U.S.C. 1395l(a)(1)(Z) and 42 U.S.C. 1395m(o).

12. Section 340B of the PHS Act, as amended (42 U.S.C. 256b).

13. Section 224(g)-(n) and (q) of the PHS Act (42 U.S.C. 233(g)-(n), and (q)).

14. 42 CFR 51c.304(d)(3)(v).

15. 42 CFR Part 491.

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