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.
Partnership Forum: Participants discussed how digital therapeutics with web and designed based applications are emerging as a means to treat conditions by engaging people to improve health and wellness.
On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Regulatory Considerations for Prescription Drug Use-Related Software”.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.
AMCP's most recent Partnership Forum drew participants from a range of backgrounds and perspectives to discuss the value of collaboration between health plans/payers and patient advocacy organizations in managed care pharmacy decision-making. Senior VP of Professional and Government Affairs Jennifer Mathieu shares key insights and takeaways from the event.
By Jennifer L. Mathieu, Senior Vice President, Professional and Government Affairs, AMCP • 12/15/23
As part of AMCP Foundation's efforts to train managed care pharmacists in specialized care practices, Raquel Erb, a PharmD candidate at the University of Texas at Austin, College of Pharmacy, completed our inaugural internship sponsored by Sanofi, studying and optimizing the benefit design of specialty drugs.