Over 130 Patient Groups Urge Secretary-designee Becerra to Maintain Key Medicare Protection for Patients
Partnership releases study showing that the Six Protected Classes policy needs strengthening, not elimination
Multi-Group Letter Sent to Becerra
The Partnership for Part D Access sent a letter today cosigned by 138 individual patient advocacy organizations to Department of Health and Human Services Secretary-designee the Honorable Xavier Becerra, highlighting the importance of Medicare’s six protected classes policy and urging the Biden administration to reject a late Trump administration proposal to eliminate the benefit.
“The protected classes policy has been a cornerstone of Part D’s success: helping to ensure that Part D formularies serve the needs of all Medicare beneficiaries, including the most vulnerable patients with the greatest need for drug coverage,” the letter states. “Accordingly, we implore you to reverse [the Trump administration] policy immediately.”
On January 19, 2021, the Center for Medicare and Medicaid Innovation (CMMI) announced the opportunity for new “formulary flexibilities” for Medicare Part D plans that participate in its Part D Payment Modernization (PDM) Model. Under the proposal, participating plans can choose to limit the drugs they cover, including denying patient access to medications used to manage complex conditions such as cancer, mental illness, HIV/AIDS, epilepsy, Parkinson’s, and organ transplantation.
Release of New Avalere Study
Today, the Partnership also released a new report, with data analysis commissioned from Avalere Health, to determine how the protected classes policy is actually being implemented. The results were not positive for patients. Indeed, according to the Avalere analysis, Part D plans are increasingly leveraging formularies and utilization management tools to limit access to medications for Medicare beneficiaries across drugs in the protected classes. For example, in 2019, the most recent year for which data is available, plans covered just 54% of drugs across the protected classes — a decrease of nearly 20% since 2016. And for those drugs that were covered, nearly two-thirds of all medications in the six protected classes were placed in a non-preferred or specialty category, which increase patient out-of-pocket costs in an effort to drive those patients towards other medications.
“As Medicare drug plans increasingly erect barriers for patients who rely on medications covered under the six protected classes, this updated study suggests that, if anything, Medicare’s protected classes policy isn’t being implemented as it should,” said Chuck Ingoglia, President and CEO of the National Council for Behavioral Health, who serves as Executive Director of the Partnership. “The Administration ought to be strengthening this vital protection — not contemplating its repeal.”
The Trump Administration’s formulary flexibility proposal is contrary to bipartisan congressional consensus, as expressed numerous times in recent years, and undermines long-standing and congressionally directed protections that guarantee access to life-saving drugs for patients with the most severe health conditions. Indeed, Congress has repeatedly expressed strong bipartisan support for the protected classes policy and has chosen to strengthen, rather than weaken it, over time. In a Senate colloquy just before the enactment of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), Senators repeatedly emphasized the role of protections, including the protected classes, available to beneficiaries who need “exactly the right medicine for them.”
Congress reaffirmed the importance of the original protected classes in Section 3307 the Affordable Care Act (ACA), which codified in law the six protected classes and categories by name, and expanded coverage to include “all” drugs within these six classes. Additionally, every Member of the Senate Finance Committee opposed CMS’ 2014 proposed rescission of protected-class protections, echoed in a separate letter from 50 Members of the House Energy and Commerce and the Ways and Means Committees. More recently, in 2019, the Trump Administration attempted to roll back these important patient protections and were again rebuffed with significant opposition from Congress. Ultimately, the policy suggesting changes to the six protected classes was withdrawn.
 149 Cong. Rec. S5887-88.
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