Applicability of the Compliance Manual
This Health Center Program Compliance Manual is designed for all health centers involved in the Health Center Program. This includes those applying for or already receiving Federal awards under Section 330 of the Public Health Service (PHS) Act (42 U.S.C. 254b). This also extends to subrecipient organizations and Health Center Program look-alikes. It’s important to note that while look-alikes don’t get direct federal funding under section 330, they must still adhere to Health Center Program requirements to maintain their look-alike status and receive associated federal benefits. In this document, “health center” encompasses all these entities: those applying for or receiving federal awards under section 330, subrecipients, and look-alike organizations.
It’s crucial to understand that this Compliance Manual applies only to activities within a health center’s Health Resources and Services Administration (HRSA)-approved scope of project. Activities outside this defined scope are not covered by this manual.
Purpose of the Compliance Manual
The primary purpose of this Compliance Manual is to serve as a comprehensive resource. It’s designed to help health centers understand and demonstrate their compliance with the Health Center Program requirements. Furthermore, the manual explains HRSA’s methods for determining eligibility, conducting oversight of the Health Center Program, and details the requirements for health professionals to gain deemed Public Health Service (PHS) employee status under section 224 (g)-(n) and (q) of the PHS Act.
This manual clearly lays out the requirements originating from the Health Center Program’s authorizing legislation, its regulations, and relevant grants regulations. These requirements are fundamental to the Health Center Program and are essential for maintaining its mission of delivering innovative and effective primary care. It’s important to remember that this Compliance Manual focuses specifically on Health Center Program requirements and HRSA’s oversight role. It does not offer guidance on broader healthcare regulations or operational best practices beyond these specific requirements.
After the release of this Compliance Manual, some Health Center Program non-regulatory policy issuances remain in effect, and these are listed in Appendix A. However, with these exceptions, this Compliance Manual takes precedence over all previous Health Center Program non-regulatory policy issuances. This includes Policy Information Notices (PINs), Program Assistance Letters (PALs), Regional Office Memoranda, Regional Program Guidance memoranda, and other similar materials related to compliance or eligibility. If there’s any conflict between this manual and other HRSA materials, the Compliance Manual is the controlling document. Specifically, this manual supersedes documents such as:
- PIN 1994-07: Migrant Voucher Program Guidance
- PINs 1997-27 and 1998-24: Documents concerning Affiliation Agreements for Community & Migrant Health Centers and amendments.
- PINs 2001-16 and 2002-22: Guidelines on Credentialing and Privileging of Health Center Practitioners.
- PAL 2006-01: Information on Dual Status-Health Centers that are both FQHC Look-Alikes and Section 330 Grantees.
- PIN 2010-01: Confirmation of Public Agency Status under the Health Center and FQHC Look-Alike Programs.
- PIN 2013-01: Guidelines for Health Center Program Budgeting and Accounting Requirements.
- PIN 2014-01: Health Center Program Governance standards.
- PIN 2014-02: Requirements for Sliding Fee Discount and related Billing and Collections Programs.
- PAL 2014-08: Details on Health Center Program Requirements Oversight.
- PAL 2014-11: Clarification of the applicability of PAL 2014-08 to Look-Alikes.
The Compliance Manual is the definitive guide for HRSA’s decisions regarding eligibility and compliance within the Health Center Program. It also forms the basis for HRSA’s review processes. HRSA may update or revise this manual to provide further clarification on demonstrating compliance with Health Center Program requirements.
Structure of the Compliance Manual
The Compliance Manual is structured to be user-friendly and clearly organized. Each chapter generally follows a consistent format:
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Authority: This section lists the relevant statutory and regulatory citations that provide the legal basis for the requirements.
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Requirements: This section states the specific statutory and regulatory requirements that health centers must meet.
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Demonstrating Compliance: This crucial section details exactly how health centers can demonstrate to HRSA that they are meeting the stated requirements. It outlines the specific elements that must be fulfilled to prove compliance.
Note: Failure to demonstrate compliance as detailed in this manual may result in a condition being placed on a health center’s award or designation. To address such conditions, health centers can demonstrate compliance by providing documentation as described in the “Demonstrating Compliance” sections. Alternatively, they can propose an alternative method of demonstrating compliance, providing a clear explanation and supporting documentation. All responses to conditions are subject to HRSA review and approval, as further explained in Chapter 2 of the Compliance Manual, titled Health Center Program Oversight*.
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Related Considerations: This section explores areas where health centers have some flexibility in decision-making. It also includes factors that health centers might find useful to consider when implementing a particular requirement. Examples provided are for illustrative purposes and are not exhaustive. All considerations are offered with the understanding that health center decisions and implementations must always align with all applicable statutory, regulatory, and policy requirements.
Additional Responsibilities for Health Centers
Beyond the requirements detailed in this Compliance Manual, health centers receiving Health Center Program Federal awards, including subrecipients, have additional obligations. These include adherence to other applicable award-related statutory, regulatory, and policy requirements. These are outlined in documents such as 45 CFR Part 75 and the U.S. Department of Health and Human Services (HHS) Grants Policy Statement (GPS), Notices of Funding Opportunity (NOFOs), and Notices of Award (NoAs). Therefore, this Compliance Manual is not an exhaustive list of all terms and conditions that may be included in NOFOs, NoAs, and other relevant laws, regulations, and policies.
Health centers, including look-alikes, must also comply with the specific statutory, regulatory, and policy requirements of other Federal programs in which they participate due to their Health Center Program award or designation. Examples include:
Each health center carries the responsibility for managing its operations and ensuring compliance with all Health Center Program requirements and all other applicable Federal, state, and local laws and regulations. This broad compliance includes laws protecting public welfare, the environment, prohibiting discrimination, as well as state facility and licensing laws, state scope of practice laws, Centers for Medicare and Medicaid Services (CMS) Conditions for Coverage for Federally Qualified Health Centers (FQHCs), and State Medicaid requirements. Health centers are encouraged to seek advice from their private legal counsel to ensure they meet all oversight and compliance responsibilities. Questions about specific programs can also be directed to the designated points of contact for those programs.
Footnotes
1. It’s important to note that Notices of Funding Opportunity (NOFOs) may specify timelines for new awardees to demonstrate compliance with the requirements in this Manual after receiving their Federal Health Center Program award.
2. References to 42 U.S.C. 1395x(aa)(4)(A)(ii) and 42 U.S.C. 1396d(l)(2)(B)(ii) provide further legal context.
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)(iii)) are also relevant.
4. For more detailed information on scope of project, please visit the Scope of Project website.
5. Please note that the Health Center FTCA Medical Malpractice Program procedures and information, as detailed in the FTCA Health Center Policy Manual (PDF – 406 KB), are not superseded by this Compliance Manual. Refer to Appendix A for other policy issuances that remain in effect.
6. Key legal foundations are 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, and 45 CFR Part 75.
7. PAL 2014-08 superseded PAL 2010-01, titled “Enhancements to Support Health Center Program Requirements Monitoring,” issued April 8, 2010.
8. These citations include requirements under the Uniform Administrative Requirements for all HHS awards (45 CFR Part 75), which apply to organizations receiving Federal funding under the Health Center Program (45 C.F.R. 75.101).
9. Additional grants policy information can be found in the HHS Grants Policy Statement and the HRSA SF-424 Application Guide. Visit the HRSA Grants website for more information.
10. Individual NOFOs may include specific additional award terms and conditions beyond what is in this manual.
11. Relevant to financial aspects are 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), concerning drug pricing, is also relevant.
13. Section 224(g)-(n) and (q) of the PHS Act (42 U.S.C. 233(g)-(n), and (q)) pertains to health center staff and liability protections.
14. Reference to 42 CFR 51c.304(d)(3)(v) for specific regulatory details.
15. Compliance with 42 CFR Part 491, concerning CMS Conditions for Coverage for FQHCs, is required.
