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)

  • 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)

  • NCPA technical comments on the Medicare Part D final rule, regarding CMS' draft of the new 2025 Prescription Drug Event (PDE) File Layouts (December 2022)

  • NCPA sign-on to comments from the Pharmacy Health Information Technology Collaborative (PHIT) to CMS' Request for Information on the National Directory of Healthcare Providers & Services (December 2022)

  • NCPA comments to CMS' Request for Information: Make Your Voice Heard, including information on pharmacy shortage areas and importance of pharmacy services. (November 2022)

  • NCPA comments to HHS' Office of Civil Rights (HHS OCR) on its Nondiscrimination in Health Programs and Activities proposed rule (October 2022)

  • NCPA comments to CY 2023 Physician Fee Schedule (September 2022)

  • NCPA joint letter with APhA, NACDS, NASP and the grocers' associations of FMI and NGA to CMS to share the pharmacy community's remaining concerns with CMS on the Medicare Part D final rule (July 2022)

  • NCPA comments on skilled nursing facilities (SNFs) proposed rule (June 2022)

Food and Drug Administration (FDA)

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

  • NCPA comments with APhA and APC asking FDA to allow pharmacists to compound ibuprofen and acetaminophen oral suspensions (January 2023)

  • NCPA comments to FDA's proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (FDA-2021-N-1351-0001) (November 2022)

  • NCPA comments to FDA's proposed rule, Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU) (November 2022)

    • NCPA joined APhA, ASCP, NASP and NACDS in signing onto a letter calling for FDA to extend the comment deadline (September 2022)

  • NCPA comments to draft guidance on DSCSA: Standards for Interoperable Exchange (September 2022)

  • NCPA comments to draft guidance on DSCSA: Identifying trading partners (September 2022)

  • NCPA comments to FDA on its proposed program regarding mail-back envelopes and education on safe disposal with opioid analgesics (June 2022)

  • NCPA comments to proposed OTC hearing aides (January 2022)

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)

Centers for Disease Control and Prevention (CDC)

  • NCPA comments in support of Novavax's COVID-19 vaccine to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) (July 2022)

Durable Medical Equipment Medicare Administrative Contractors (DME MACs)

  • NCPA comments in support of the Proposed Local Coverage Determination Modifying Coverage Criteria for Continuous Glucose Monitors (CGMs) (November 2022)