Legislation & Regulation

On January 17, AMCP joined dozens of other pharmacy organizations in a joint letter which expresses concerns about the FDA's recent authorization of Florida's state drug importation program. The undersigning organizations believe this importation program may lead to the importation of harmful and counterfeit drugs into the United States, with little evidence of cost savings. The organizations remain committed to alleviating the high cost of medicines in the United States, but oppose state drug importation programs that may compromise patient safety.

On Jan. 11, AMCP joined with 65 other healthcare organizations in a sign-on letter urging the Biden Administration to implement policies that would stabilize and support a strong, sustainable Medicare Advantage program for its beneficiaries. The letter comes as the Administration and CMS continue to enact significant policy changes to the Medicare Advantage program, which serves 51 percent of the Medicare population.

On November 24, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan Program; and Basic Health Program”. This rule lays out standards for health insurance issuers, Affordable Care Act (ACA) insurance Marketplaces, and other relevant entities. AMCP submitted comments in response to this rule on January 8, 2024.

On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Medicare Program; Contract Year 2025 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; Health Information Technology Standards and Implementation Specifications”. This rule touches on a variety of topics, including behavioral health specialties, criteria for Special Supplemental Benefits for the Chronically Ill, mid-year notification of availability of supplemental benefits, agent/broker compensation, health equity analysis of utilization management, validation of Part C and D reporting requirements, appeal rights for terminating coverage for non-hospital provider services, midyear substitution of biosimilars, dual-eligible enrollment periods, out-of-network cost-sharing for D-SNP PPOs, and MA RADV appeal regulations. AMCP submitted comments in response to this rule on January 5, 2024.

On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Regulatory Considerations for Prescription Drug Use-Related Software”. This guidance describes how FDA intends to apply its drug-labeling authority to certain software outputs for use with a prescription drug or a prescription drug-led, drug-device combination product. In this guidance, prescription drug use related software generally includes software that (1) is disseminated by or on behalf of a drug sponsor and (2) produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products. FDA considers end-user output a type of prescription drug labeling. AMCP submitted comments in response to this guidance on December 18, 2023.