Partnership Condemns 'Midnight' Regulation to Gut Medicare Patient Protections

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. 

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There are two key flexibilities that are being offered to participating plans beginning in CY 2022:

• plans would be permitted to cover only one drug per therapeutic class, rather than two under the current requirements; and
• plans could treat five of Medicare’s six protected classes as if they were any other class of drug, no longer requiring coverage of “all or substantially all” of the drugs in those classes. CMS says that the sixth protected class — antiretrovirals — will also be treated as any other class for CY 2023.

 
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:

“This hasty midnight regulation is a step against some of the most vulnerable people in our communities and the bipartisan lawmakers who have tirelessly defended the merits of Medicare’s protected classes policy. We look forward to working with the Biden administration and Congress to ensure we give people in our nation with the most complex conditions — including cancer, mental illness, HIV-AIDS, epilepsy, Parkinson’s, and organ transplantation — access to the medication they need to best achieve the next step of a treatment plan… but more importantly, giving them hope for the future.”

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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• Nineteen Energy & Commerce and Ways a& Means Committee Democrats sent a letter to HHS;
• Fourteen bipartisan Senators sent a letter to CMS; 
• Seventy-three House Members sent a letter to HHS; and 
• Thirty-nine members of the Congressional Mental Health Caucus sent a letter to HHS.