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 the latest regulatory policies impacting health centers, check out NACHC’s blog.

If you have any questions, please contact


340B Office Hours

340B Eligible Scripts

Fact Sheet: State Waiver Options
Recent CMS Informational Bulletins on Waivers 

Regulations & Guidance Currently open for comment

Title Summary Comments Due
CMS Innovation Center Request for Information on A New Direction  CMS is seeking feedback on a new direction to promote patient centered care and test market-driven reforms that empower beneficiaries as consumers,
provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes.
improve outcomes.



Comments Recently Submitted on NPRMs and Guidances

Title  (click for link to document) Summary NACHC Comments (Click for link to comments)
Proposal to Further Delay Effective Date of 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation until July 1, 2018 This proposal delays the effective date of the rule which outlines the calculation of the 340B ceiling price and application of civil monetary penalties.  NACHC Comments
FCC Request for Comment on Actions to Accelerate Adoption and Accessibility of Broadband-Enabled Health Care Solutions   Federal Communications Commission (FCC) seeks comment, data, and information on a variety of regulatory, policy, and infrastructure issues related to the emerging broadband-enabled health and care ecosystem. See the NACHC summary for more information. NACHC Comments
Interim Final Rule, Delay of Effective Date of 340B Ceiling Price and  Civil Monetary Penalties This interim final rule delays the effective date of the rule which outlines the calculation of the 340B ceiling price and application of civil monetary penalties.  NACHC Summary  NACHC Comments
Proposed Rule on Market Stabilization in the Affordable Care Act This rule proposes changes that would help stabilize the individual and small group markets. This proposed rule would amend standards relating to special enrollment periods, guaranteed availability, and the timing of the annual open enrollment period in the individual market for the 2018 plan year; standards related to network adequacy and essential community providers for qualified health plans; and the rules around actuarial value requirements. NACHC 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
CMS Final Rule on the CY 2018 Updates to the Quality Payment Program Final Rule  This proposed rule provided new updates to the Quality Payment Program.

NACHC Comments

CMS Rule on CY 2018 Physician Fee Schedule and other Medicare provisions Final Rule This proposed rule provides updates to many Medicare Part B provisions and includes certain FQHC-specific provisions around Chronic Care Management (CCM), Collaborative Care Management and other services.

NACHC Summary 

NACHC Comments

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 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