Regulatory Issues

NACHC monitors the health care regulatory environment to identify emerging and new federal regulatory issues and policies that that can affect health centers and their patients. In this area, it:

  • Reviews and comments on Federal policies (proposed regulations, guidances, etc.)
  • Educates primary care associations and health centers about emerging Federal policy issues
  • Supports primary care associations and health centers in submitting their own comments on Federal policies

An overview of the Federal regulatory process

Tips for writing effective comments

How to submit comments

For an in-depth look into latest regulatory policies impacting America’s health centers, check out NACHC’s Policy Shop blog.

If you have any questions, please contact



NACHC Regulatory Affairs: A Year in Review

CMS MLN Matters Article on 2017 Medicare FQHC PPS Rates 

Fact Sheet: MACRA and Health Centers

Fact Sheet: Section 1557 and Health Centers 

Regulations & Guidance Currently open for comment

Title Summary Comments Due



Comments Recently Submitted on NPRMs and Guidances

Title  (click for link to document) Summary NACHC Comments (Click for link to comments)
Draft BPHC Compliance Guide The Bureau of Primary Health Care (BPHC) has released a draft Health Center Program Compliance Manual (the Compliance Manual) for public comment. The Health Center Compliance Manual serves as a web-based policy resource to assist in understanding and demonstrating compliance with Health Center Program requirements.

Changes to NACHC Comments on Compliance Guide from 10.31.16 to 11.22.16

NACHC Comments


340B Drug Pricing Program: Administrative Dispute Resolution Process   The proposed rule sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution process, which will apply to all drug manufacturers and covered entities that participate in the 340B Program. 340B Coalition Comments 
CMS Proposed Rule on Marketplace Benefit and Payment Parameters for Plan Year 2018 This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. NACHC Comments
CMS Request for Information on Inappropriate Steering of Individuals Eligible for or Receiving Medicare and Medicaid Benefits to Individual Market Plans CMS is seeking public comment on concerns about health care providers and provider-affiliated organizations steering people eligible for or receiving Medicare and/or Medicaid benefits to an individual market plan for the purpose of obtaining higher payment rates. CMS is concerned about reports of this practice and is requesting comments on the frequency and impact of this issue from the public. NACHC Comments

Final Regulations & Guidances Recently Published

Title Type* Summary
HHS Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Final Rule  This rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties.  NACHC Summary 
CMS Rule on the Medicare Physician Fee Schedule and other provisions  Final Rule  This final rule makes a variety of changes to the Medicare program.  Of note for FQHCs specifically, it eases the requirements for FQHCs providing Chronic Care Management and creates an FQHC specific marketbasket to serve as an annual update factor for the Medicare PPS.
CMS Rule on the Medicare Merit-Based Incentive Payment System (MIPS) and Alternative Payment Methodologies (APMs) Final Rule This rule establishes the Medicare Merit-Based Incentive Payment System and Alternative Payment Methodologies,  as passed in the Medicare and CHIP Reauthorization Act (MACRA).

While this proposed rule largely does not impact federally qualified health centers (FQHCs) and their Medicare payments, it does include a provision for FQHCs to voluntarily report certain measures.

CMS Final Rule on Emergency Preparedness for Medicare and Medicaid Participating Providers and Suppliers Final Rule This final rule sets emergency preparedness standards for Medicare and Medicaid providers. 

For more information on proposed legislation or NACHC comments, please email

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