Letters, Statements & Analysis
AMCP communicates the importance of managed care pharmacy by collaborating with members to provide comments, analysis, and testimony to Congress and federal and state agencies on the impact of proposed regulations and laws on managed care pharmacy and patients.
On January 31, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Advance Notice of Methodological Changes for Calendar Year (CY) 2025”. Each year, CMS is required to update MA payment rates and regularly conducts technical updates through the Advance Notice and Rate Announcement process. AMCP submitted comments in response to this rule on March 1, 2024.
On January 31, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Draft Guidance titled “Draft Part D Redesign Program Instructions (Program Instructions)”, concurrently with the Advance Notice. The Draft Part D Redesign Program Instructions provide draft guidance regarding the implementation of certain Inflation Reduction Act (IRA) provisions relating to the Part D drug benefit. CMS is soliciting comments on all aspects of the Guidance, and notes that policies established in the final Guidance are for 2025. AMCP submitted comments in response to this rule on March 1, 2024.
On January 30, AMCP joined 24 patient and provider organizations in filing an amicus brief which urges the Supreme Court to reverse the Fifth Circuit's decision in "Alliance for Hippocratic Medicine et al. v FDA et al". The filing organizations believe that the ruling threatens the FDA's role in ensuring Americans' access to safe, effective drugs and treatments.
On December 5, Senate Health, Education, Labor, & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a Request for Information (RFI) titled "Improving Access to Americans' Gene Therapies." On January 22, AMCP submitted a letter in response, which positions the Medicaid VBPs for Patients (MVP) Act of 2023 (H.R. 2666) as a useful tool for improving access to and the affordability of emerging cell and gene therapies. The MVP Act of 2023 codifies the existing “multiple best price” rule that allows manufacturers to report multiple best prices, the lowest drug price paid by any health payer, for drugs that are subject to value-based purchasing arrangements when certain other criteria are met.
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.
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.
