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 November 20, HHS released an Interim Final Rule with Comment Period (IFC) establishing a Most Favored Nation (MFN) Model for Medicare Part B drugs. The MFN Model will calculate the payment rate for included drugs based on a price that reflects the lowest per capita GDP-adjusted price among a group of OECD countries, with an additional flat payment based on the average payment for MFN Model drugs in 2019 adjusted quarterly for inflation.
On November 20, HHS released a Final Rule that amends the discount safe harbor regulation to eliminate protections for price concessions offered by pharmaceutical manufacturers to plan sponsors and pharmacy benefit managers (PBMs) under contract with plan sponsors starting January 1, 2022.
On November 2, AMCP submitted comments on a CMS Medicare Coverage of Innovative Technology proposed rule establishing a national coverage pathway for innovative devices authorized under FDA’s Breakthrough Devices Program and clarifying the agency’s definition of “reasonable and necessary”. AMCP called on CMS to indicate how digital therapeutics (DTx) will fit into Medicare’s coverage and payment framework in its Final Rule.
On November 2, AMCP submitted comments on CMS’s Third Interim Final Rule responding to the COVID-19 emergency, thanking the agency for granting pharmacists the authority to order COVID-19 diagnostic tests for Medicare beneficiaries and expressing concern about the agency’s new guidance which would limit COVID-19 diagnostic tests without an order.
The efficient, well-coordinated distribution, allocation, and mass vaccination activities against the novel coronavirus (SARS-CoV-2) will help ensure vaccination is an effective countermeasure to the current pandemic.
On Oct. 5, AMCP submitted comments about the Part D MTM program, specifically in regards to the ability of plan sponsors and MTM vendors to provide annual CMR to individuals other than the beneficiary in certain circumstances in which the beneficiary is unable to participate.
On September 25, FDA issued a final rule related to the importation of prescription drugs from Canada.
AMCP submitted comments in response to a request for information on how to improve the FDA Orange Book.
Read AMCP's summary of the Medicare Coverage of Innovative Technology proposed rule that would provide a national coverage pathway for breakthrough devices, including digital therapeutics.
AMCP signed on to joint comments on the National Academies of Science, Engineering, and Medicine’s draft Preliminary Framework for COVID-19 Vaccine, advocating for the inclusion of pharmacists as front line health care workers.
AMCP submitted comments to the National Academies of Science, Engineering, and Medicine’s draft Preliminary Framework for COVID-19 Vaccine detailing our support to recognize pharmacists as front-line health care workers and pharmacies be included in the vaccine distribution and allocation plans.
AMCP sent a letter to HHS Secretary Azar detailing our concerns with the recent Executive Order that would make changes to the anti-kickback statute safe harbor for manufacturer rebates and the potential for increased costs for patients.
