On August 10, the Biden Administration announced its plan via a proposed rule to rescind the Most Favored Nation (MFN) rule instituted during the waning days of the Trump Administration. The MFN set drug prices for Medicare Parts B and D to “the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the Organisation for Economic Co-operation and Development that has a comparable per-capita gross domestic product.” A major concern regarding the MFN model rule was its mandatory implementation across all Medicare participants and the resulting narrowing of available treatments for beneficiaries based on a list of high cost drugs. The rule noted the savings to Medicare were a result of patients’ inability to access life-saving medications used to treat cancer and manage chronic conditions due to a 19% loss of access after a seven-year phase-in period.
In the proposed rule, the Biden Administration states they plan to explore options to incorporate value into Medicare B drug payments and improve beneficiaries’ access to evidence-based care. The Department of Health and Human Services is developing a plan to lower the prices of and improve access to prescription drugs which will be released to the public in the coming weeks. This plan, along the provisions to lower drug prices that we anticipate will be included in Congressional Democrats’ reconciliation package, will provide more information on how the administration and Congress plan to tackle this important issue.
The AUA previously led efforts within the urologic community to oppose the MFN. On May 4, the AUA sent a joint letter to the Center for Medicare & Medicaid Services (CMS) urging them to withdraw the proposed MFN rule. As the Biden Administration seeks comments on value-based care and the price of Medicare Parts B and D drugs, the AUA will continue to provide expertise and analysis to stakeholders and CMS. The AUA remains committed to ensuring high quality of care from providers and access to life-saving treatment for patients.