Federal Regulatory Comment Letters

PCMA comments on CMS’s request for comment on Part D prior authorization data submissions, supporting transparency improvements while emphasizing phased implementation, flexibility, and continued collaboration to ensure operational feasibility.

PCMA comments on DOL’s PBM fee disclosure proposal, urging the department to withdraw the proposal, and it the event they cannot, consider alignment with new federal law and avoidance of regulatory overreach that would burden employers, plans, and multiemployer trusts.

PCMA comments on HHS and CMS’s CRUSH RFI, urging policies that strengthen program‑integrity tools and empower PBMs to better combat fraud, waste, and abuse across federal programs.

PCMA comments on OIG’s RFI on direct‑to‑patient prescription drug sales, calling for clear guardrails to prevent fraud and abuse, protect beneficiaries, and ensure DTP models do not undermine benefit design or care coordination.

PCMA comments on CMS’s 2027 proposed rule governing health insurance exchanges, urging changes to EHB and standardized plan policies that would reduce premium pressure, limit adverse selection, and improve marketplace affordability and stability.

PCMA comments on ASTP/ONC’s health care technology and interoperability rule (the 5th in a series of rules), supporting targeted deregulation while urging the agency to preserve core interoperability, privacy, and security standards during the transition to API‑based exchange.

PCMA comments on CMS’s CY 2027 Medicare Advantage and Part D Advance Notice, urging payment and risk‑adjustment policies that stabilize the Medicare market and protect beneficiary affordability and access.

PCMA comments on the Transparency in Coverage proposed rule, recommending targeted prescription drug disclosures, once additional information on prescription drug MRFs is released, that reduce administrative burden, protect confidential negotiations, and deliver meaningful, actionable transparency for consumers and plan sponsors.

PCMA comments on HHS’s request for information on the clinical use case for artificial intelligence, supporting a risk‑based, use‑case‑specific approach to AI regulation and policies that encourage responsible adoption, innovation, and improved patient outcomes without duplicative oversight.

PCMA comments on CMMI’s proposed GUARD “Most Favored Nations” model in Medicare Part D, urging changes to ensure manufacturer accountability, minimize operational burden, preserve patient access, and prevent unintended pricing and market distortions.

PCMA comments on CMMI’s proposed GLOBE “Most Favored Nations” drug pricing model in Medicare Part B, urging safeguards to protect patient access, prevent market disruption, ensure manufacturer accountability, and avoid unintended consequences.

PCMA comments on CMS’s CY 2027 Medicare Advantage and Part D proposed rule, urging policies that stabilize the Part D marketplace, reduce regulatory burden, and align IRA implementation with statutory intent.

Re: Request for Information (RFI): Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again [AHRQ–2025–0001]

Re: Prescription Drug Machine-Readable (MRF) Requirement in the Transparency in Coverage Final Rule, Request for Information (RFI) [IRS_FRDOC_0001-2324]

Re: Medicare Drug Price Negotiation Program Draft Guidance

RE: Request for Information on Health Technology Ecosystem [CMS–0042–NC]

Re: Unleashing Prosperity Through Deregulation of the Medicare Program Request for Information (RFI), (Executive Order 14192)

RE: Advance Notice of Methodological Changes for Calendar Year (CY) 2026 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies

RE: Draft CY 2026 Part D Redesign Program Instructions

RE: Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly [CMS- 4208-P]