Legislation & Regulation

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On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Regulatory Considerations for Prescription Drug Use-Related Software”.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.

Patients need to be aware of the dangers of fake medicines, potentially causing disease progression, adverse events, and even death. AMCP supports the joint statement released by National Association of Boards of Pharmacy and other health care organizations on fighting fake medicines bought online.

On October 4, 2023, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issued a request for information titled “Coverage of Over-the-Counter Preventive Services”. This request is regarding the application of the preventive services requirements under the Public Health Service Act to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. Some examples could include certain types of tobacco cessation pharmacotherapy, folic acid supplements, breastfeeding supplies, and contraceptives such as a recently approved OTC progestin-only daily oral contraceptive. Additional recommended preventive products may become available OTC in the future. AMCP submitted comments in response to the proposed rule on December 4, 2023.

On September 18, 2023, the Office of Management and Budget (OMB) issued the draft guidance titled “Advancing Governance, Innovation, and Risk Management for Agency Use of Artificial Intelligence”. While AI is improving operations and efficiency across the Federal Government, agencies must effectively manage its use. As such, this memorandum establishes new agency requirements and guidance for AI governance, innovation, and risk management, including through specific minimum risk management practices for uses of AI that impact the rights and safety of the public. The document focuses on three main pillars: .Strengthening AI governance; .Advancing responsible AI innovation; and .Managing risks from the use of AI by directing agencies to adopt mandatory safeguards for the development and use of AI that impacts the rights and safety of the public. AMCP submitted comments in response to the proposed rule on December 1, 2023.

On May 30, 2023, Food and Drug Administration (FDA) issued the proposed rule titled “Medication Guides: Patient Medication Information”. The purpose of this rule is to amend its human prescription drug product labeling regulations for Medication Guides (FDA approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. AMCP submitted comments in response to the proposed rule on November 27, 2023.