On their final day in office, the outgoing Trump Administration, through the Centers for Medicare and Medicaid Services (CMS), announced a new proposal that would undermine key patient protections in Medicare's prescription drug program. Indeed, policy outlined in a new Request for Applications (fact sheet) would allow Medicare Part D plans that participate in the third year of the Center for Medicare and Medicaid Innovation’s (CMMI) Part D Payment Modernization (PDM) Model to limit the drugs they cover, including denying patients access medications used to manage complex conditions such as cancer, mental illness, HIV-AIDS, epilepsy, Parkinson’s, and organ transplantation. The Biden Administration will have authority to determine whether the new policy is ultimately implemented.
There are two key flexibilities that are being offered to participating plans beginning in CY 2022:
In exchange for these new flexibilities, plans would accept two-sided risk for the federal share of the catastrophic phase of the Part D benefit. CMS notes, however, that it has not yet waived the requirements of the Social Security Act to allow for these changes, and the Biden Administration has significant authority to block the new regulations from going into effect.
In response to the proposal, Chuck Ingoglia, who serves as Executive Director of the Partnership for Part D Access in addition to his role as President and CEO National Council for Behavioral Health, issued the following statement:
Meanwhile, significant support exists for the protected classes policy among leading patient advocacy organizations and patient stakeholders. For example, in 2019 when the Trump Administration last proposed weakening the protected classes policy, more than 120 Members of Congress joined in bipartisan letters to the Trump Administration in opposition to the proposed changes:
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