NCPA Regulatory Advocacy

NCPA follows regulatory affairs closely and provides comments whenever possible on behalf of its members. Please see below for our most recent comments and letters. For our compounding advocacy, click here.

Centers for Medicare and Medicaid Services (CMS) and Health and Human Services (HHS)

  • NCPA comments to CMS’ calendar year 2025 physician fee schedule (September 2024)

  • NCPA comments to CMS requesting contract guardrails for PBMs and plans in Medicare Part D (September 2024)

  • NCPA comments to CMS’ draft guidance on the Medicare Drug Price Negotiation Program (July 2024)

  • NCPA letter to CMS requesting clarity, accountability for Cigna’s Express Scripts’ “bonus pool fees” (May 2024)

  • NCPA comments to CMS’ request for information on Medicare Advantage (May 2024)

  • Joint NCPA/NACDS letter to CMS on new Medicare Part D $2 drug list model (May 2024)

  • Joint NCPA/ASHP/ACCP/ASCP/APhA/NASPA letter to HHS calling for pharmacy protections from cyber-attacks (May 2024)

  • Joint NCPA/NACDS letter to HHS to exempt pharmacies from breach notifications in wake of Change Healthcare/UnitedHealth Group cyber-attack (May 2024)

  • Joint NCPA/APhA/NACDS letter to CMS calling to end utilization management for vaccines (April 2024)

  • Joint NCPA/APhA/NACDS/ASCP/NASPA/ASHP comments to CMS’ Draft Part Two Guidance on the Medicare Prescription Payment Plan (M3P, formerly known as “co-pay smoothing”) of the Inflation Reduction Act (March 2024)

  • NCPA comments to CMS on outstanding cash flow concerns in Medicare Part D and asking CMS to enforce contract protections against PBMs (with NCPA member survey results attached) (February 2024)

  • NCPA comments to CMS on the Advance Notice of Rate Changes to Medicare Part D and Medicare Advantage (February 2024)

  • NCPA comments to CMS on CY 2025 policy changes to Medicare Advantage and Medicare Part D (December 2023)

Food and Drug Administration (FDA)

  • Joint NCPA/NACDS/HDA letter recommending that FDA revise its numbers of expected requests from trading partners under FDA’s “Waivers, Exceptions, and Exemptions” (“WEE”) process (November 2024)

  • Joint NCPA/AACP/ACCP/APhA/ASCP/ASHP/NACDS/NASPA letter calling for greater DSCSA flexibility (August 2024)

  • NCPA comments to FDA’s comment request on the small dispenser assessment for DSCSA (May 2024)

  • NCPA comments to FDA’s request for information and comments on implementing interoperable systems and processes for the DSCSA (February 2024)

Federal Trade Commission (FTC), Department of Justice (DoJ)

  • NCPA comments to DOJ, FTC and HHS on their request for information on the consolidation of health care markets (June 2024)

Customs and Border Protection (CBP )

  • Joint NCPA/NACDS comments to CBP on ruling on prescription marking for country of origin (COO) (October 2024)

Regulatory Advocacy to Congress

  • Joint sign-on letter with various non-pharmacy organizations to House calling for a delay on the Corporate Transparency Act (CTA)’s year-end compliance deadline (September 2024)

  • Joint sign-on letter with various non-pharmacy organizations to House and Senate calling for the repeal of the Corporate Transparency Act (CTA) (April 2024)

  • NCPA comments to the Senate 340B bipartisan working group on the SUSTAIN 340B Act draft legislation (March 2024)

Regulatory Advocacy to PBMs and Plans