Legislation & Regulation

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On May 12, CMS released new draft guidance on the Manufacturer Discount Program, enacted into law as part of the Inflation Reduction Act of 2022 (IRA). In response to the draft guidance, AMCP submitted comments on June 12.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.

On March 17, CMS announced an opportunity for the public to comment on the agency’s initial guidance for the Medicare Drug Price Negotiation Program, as required by the Inflation Reduction Act. Given the anticipated impact of the Drug Price Negotiation program on the practice of managed care pharmacy in the United States, AMCP took the opportunity to submit comments on several provisions outlined in CMS’ guidance. AMCP’s comments cover subject areas such as access to the Maximum Fair Price, manufacturer-specific data required for negotiation, evidence about therapeutic alternatives for the selected drug, CMS’ methodology for developing an initial offer, the removal of a drug from the selected drug list, and Part D formulary inclusion of the selected drug.