Letters, Statements & Analysis

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics” (Draft Guidance), issued on December 5, 2024.

The Academy of Managed Care Pharmacy (AMCP) issued the following statement from AMCP CEO Susan A. Cantrell, MHL, RPh, CAE, regarding President Trump’s new and proposed tariffs on U.S. imports from Canada, Mexico, and China: “Although President Trump’s new and proposed tariffs aim to level the playing field between American industries and our foreign competitors, we are concerned about the unintended, adverse consequences they may have on the cost of medicines in the U.S.

AMCP shared comments with Centers for Medicare & Medicaid Services (CMS) on the proposed 2026 Policy and Technical Changes to the Medicare Advantage (MA) Program. We applaud CMS’ efforts to address obesity and emphasized the importance of managing costs. AMCP urged CMS to issue guidance on managing drugs in this class to effectively treat obesity as a chronic disease. On the Medicare Transaction Facilitator, we advised CMS to avoid adding unnecessary costs and administrative burdens. We support CMS’ focus on increasing access to generics, biosimilars, and other affordable medications. Lastly, we provided insights on proposed changes to Star Ratings, ensuring member perspectives are represented.

On Jan. 20, 2025, newly inaugurated President Trump signed dozens of Executive Orders concerning a number of G.O.P. policy priorities, including but not limited to: immigration and border security, trade and economic policy, the federal workforce, energy and environmental policy, law and order, and social policies. While health care was not a primary focus of these executive actions, President Trump did withdraw the United States from the World Health Organization and revoked several Biden-era actions related to health policy. Executive Orders are directives from the president that manage operations of the federal government, have the effect of law, may be promulgated by government agencies, and may be overturned by judicial review if they lack support by existing law or the Constitution.

The Academy of Managed Care Pharmacy (AMCP) thanks the Department of Health and Human Services, the Department of Labor, and the Department of the Treasure (collectively, the Departments) for the opportunity to provide comments in response to the proposed rule titled “Enhancing Coverage of Preventive Services Under the Affordable Care Act [CMS 9887–P]” published in the Federal Register on October 28, 2024.

The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to provide feedback on the “Medicare $2 Drug List Model” issued by CMS.

On November 21, the New York Department of Financial Services (DFS) announced sweeping market conduct regulations for pharmacy benefit managers (PBMs) serving health plans in the state. The DFS rule implements a landmark 2021 bill, S. 3762/A. 1396, which imposed restrictions on PBM contracts with health plans and pharmacies and established consumer protections. This action follows previous DFS rulemaking that created a broad definition of pharmacy benefit management services, required PBMs operating in the state to obtain a license, and established annual reporting requirements.

AMCP Comments on PREVENT HPV Cancers Act

On September 9, AMCP submitted comments praising CMS’s proposal to cover Digital Mental Health Treatment devices (DMHTs) under Medicare Part B. AMCP urges CMS to use its authority to cover all FDA-cleared, prescription only digital health products and develop appropriate coding and payment methodologies to promote adoption of these innovative technologies.

View AMCP letter urging Congress to support 12-month continuous eligibility for adults in Medicaid and the Children’s Health Insurance Program (CHIP) by passing the Stabilize Medicaid and CHIP Coverage Act

View AMCP comments to the FDA on considerations in demonstrating biosimilar interchangeability with a biologic reference product.