Legislation & Regulation

AMCP sends letter of concern for needed provisions in the Senate amendment in the nature of a substitute of H.R. 6 to Senate leadership and the Chairs and Ranking Members of HELP, Finance, Judiciary, and Commerce committees

On August 7, 2018, CMS issued guidance to Medicare Advantage (MA) plans acknowledging that step therapy is a recognized utilization management tool. CMS stated that the allowance of step therapy practices for Part B drugs will help achieve the goal of lower drug prices while maintaining access to covered services and drugs for beneficiaries. MA plans will have the choice of implementing step therapy to manage Part B drugs, beginning January 1, 2019.

AMCP comments on state legislation on e-prescribing.

AMCP comments on legislation that would increase competition and decrease patients' drug costs.

On July 13, 2018, AMCP provided comments in response to FDA Final Guidance on Payor- Manufacturer communications. AMCP supported the need for timelier and more proactive communications between biopharmaceutical manufacturers and population health decision makers. AMCP applauded the FDA for its leadership and recognition of the importance of modernizing the provisions of the Food and Drug Administration Modernization Act (FDAMA) Section 114 as amended by Section 3037 of the 21st Century Cures Act (Cures) and the creation of a safe harbor for the exchange of preapproval communications.

AMCP participants in sign-on letter from 60 organizations in support of increasing FDA funding for FY 2019.