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 DIR advocacy, click here, and for our compounding advocacy, click here.

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

  • 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)

  • NCPA comments to CMS on the Medicare Transaction Facilitator for the Medicare Drug Price Negotiation Program (November 2023)

  • NCPA joint comments with NACDS on CMS’ guidance on the Medicare Prescription Payment Plan (formerly "copay smoothing") of the Inflation Reduction Act. (September 2023)

  • NCPA comments to CMS on the CY 2024 physician fee schedule (September 2023)

  • NCPA comments to CMS on the proposed National Coverage Analysis (NCA) on HIV PrEP (August 2023)

  • NCPA comments to CMS on the Medicaid proposed rule (July 2023)

  • NCPA comments to CMS on Medicare Drug Price Negotiation Program Initial Guidance (April 2023)

  • NCPA letter to CMS requesting that CMS expediently propose data elements that are used by Part D plans to assess pharmacy performance (March 2023)

  • NCPA comments to CMS on how CMS can identify 340B units dispensed in Medicare Part D (March 2023)

  • NCPA comments to the Advanced Notice for FY 2024 changes to Medicare Advantage and Part D (March 2023)

  • NCPA comments to HHS' proposed rule on the National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards (January 2023)

  • NCPA comments to the Request for Information on Essential Health Benefits, including information on adequate pharmacy access (January 2023)

Food and Drug Administration (FDA)

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

  • NCPA comments to FDA’s proposed rule on Medication Guides: Patient Medication Information (November 2023)

  • Joint NCPA/APhA joint comments on FDA RFI for DSCSA small dispenser survey (September 2023)

  • NCPA comments to FDA’s request for information on in home disposal of opioid analgesics (August 2023)

  • NCPA comments to FDA on OTC naloxone (January 2023)

Drug Enforcement Administration (DEA)

  • NCPA comments on the Controlled Substances Ordering System modernization (April 2023)

  • NCPA comments on telemedicine, controlled substances and buprenorphine (March 2023)

Substance Abuse and Mental Health Services Administration (SAMHSA)

  • NCPA, APhA and NASPA comments to SAMHSA on how it and other federal agencies can improve pharmacy access to buprenorphine (September 2022)

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

  • NCPA comments to the FTC and the Antitrust Division of the DoJ on their draft "merger guidelines" (September 2023)

Regulatory Advocacy to Congress

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