ARM Statement on the Trump Administration's Interim Final MFN Rule

Washington, DC – January 26, 2021

ARM today called on the Biden administration to withdraw in its entirety the Trump administration’s Interim Final Rule on the Most Favored Nation (MFN) model for Medicare Part B. The MFN approach is particularly misguided for cell, gene, and tissue-based therapies. These durable – and possibly curative – therapies address the root causes of disease and contribute to more sustainable healthcare systems. Furthermore, patient access to the most innovative therapies in the countries upon which the MFN model is based lags considerably behind the US. Even if CMS were to exclude certain cell and gene therapies from the MFN model today, the innovators of tomorrow will face uncertainty. We encourage the Biden administration to instead consider the adoption of innovative payment models that recognize the unique promise of regenerative medicine, including by tying reimbursement to patient outcomes.


About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 370+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit