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 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.
On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued the draft guidance titled “Labeling for Biosimilar and Interchangeable Biosimilar Products”. AMCP submitted comments in response to the proposed rule on November 17, 2023.
On September 14, 2023, the Department of Health and Human Services (HHS) and the Office for Civil Rights issued the proposed rule titled “Discrimination on the Basis of the Disability in Health and Human Service Programs or Activities". AMCP submitted comments in response to the proposed rule on November 13, 2023.
On Aug. 30, 2023, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issued the proposed rule titled “Requirements Related to the Mental Health Parity and Addiction Equity Act. AMCP submitted comments in response to the proposed rule on Oct. 17.
On August 21, 2023, CMS Issued the Maximum Monthly Cap on Cost-Sharing Payments Under Prescription Drug Plans: Draft Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025. The purpose of this document is to provide interested parties with draft part one guidance on a select set of topics for the Maximum Monthly Cap on Cost-Sharing Payments Program.
On June 22, CMS unveiled proposed guidance titled "Coverage with Evidence Development." Given AMCP's commitment to addressing health disparities in medication use and access, AMCP submitted comments in response to the proposed guidance on Aug. 21.
On July 25, 2023, AMCP commented on the Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program [CMS-2434-P].
On April 18, HHS' Office of the National Coordinator for Health Information Technology released a proposed rule titled "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing." AMCP submitted comments in response to the proposed rule on June 20.
In April, the Department of Health and Human Services published a proposed rule titled "HIPAA Privacy Rule to Support Reproductive Health Care Privacy." AMCP took the opportunity to submit comments and suggestions in support of the rule on June 16.
On May 12, CMS released new draft guidance on the Manufacturer Discount Program, enacted into law as part of the Inflation Reduction Act of 2022 (IRA). In response to the draft guidance, AMCP submitted comments on June 12. In the comment letter, AMCP urges CMS to continue to take precautions against potential unintended consequences throughout its implementation of the IRA.
On May 15, AMCP joined dozens of other health care organizations in a sign-on letter thanking the Biden Administration for relaunching the Cancer Moonshot program. First launched in 2016 with the mission to accelerate the rate of progress against cancer, the program's national goal is to reduce the death rate of cancer by at least 50% over the next 25 years. The letter applauds the program's prioritization of cancer prevention, especially though human papillomavirus (HPV) vaccination.
On April 27, AMCP submitted comments in response to the Office of Management and Budget's Initial Proposals for Updating Race and Ethnicity Standards. In the comment letter, AMCP provides several recommendations which align with the organization's strategic priority of Addressing Disparities in Medication Use and Access.
