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Shelley Starkey

Finalized Rule from CMS Preserves Medicare’s Six Protected Classes

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The Centers for Medicare and Medicaid Services (CMS) released a final rule on Thursday aimed at addressing rising drug prices and out-of-pocket expenses under Medicare Part D and Medicare Advantage. Notably, the final rule did not include previously-proposed measures that would have provided exceptions to Medicare’s “six protected classes,” a policy that ensures beneficiaries with complex health conditions, including mental illness, have access to a full range of medication treatment options. The announcement comes after six months of opposition to the proposals from Members of Congress and patient and provider advocates, including the National Council for Mental Wellbeing.


The originally proposed rule, released back in November 2018, threatened Medicare Part D participants’ access to critical prescription drugs, including those often needed by individuals living with mental illness. Under current law, Medicare Part D plans must provide access to all or substantially all medications within the “six protected classes,” including critical prescription drugs that support patients with mental health conditions, epilepsy, Parkinson’s disease, lupus, HIV/AIDS, cancer, and organ transplants. The proposed rule would have allowed Part D insurers to require patients who have been stabilized on a medication regimen for years to try different, cheaper medications or receive prior authorization when they enroll in or switch between Part D plans, resulting in potentially catastrophic consequences.

In response, advocates mobilized to make CMS aware of how harmful the rule would be if enacted as written. The National Council for Mental Wellbeing signed onto letters, submitted official comments, created advertisement campaigns, and participated in educational briefings for Members of Congress and Administration officials to raise awareness for the importance of this issue. At a briefing last week, Michael Petruzzelli, National Council’s Manager of Policy and Advocacy, said “The patient population being covered by this policy are some of our nation’s most complex, costly and challenging patients to help. They should be given every opportunity to achieve and maintain wellness with their treatment regimen.”


Following the public comment period, CMS’s final rule significantly walked back these proposals, and leaves the current environment under Medicare Part D’s protected classes largely unchanged. Of the proposed exceptions to the protected classes, the agency finalized an allowance for prior authorization (PA) and step therapy (ST) in part, allowing the practices for new starts, but did not implement other proposed restrictions. Other provisions that did make their way into the final rule include measures aimed at giving Medicare enrollees and their doctors more transparency on medication options and costs via new requirements for real-time drug pricing data, and requirements to include drug pricing information in enrollees’ explanation of benefits.

The National Council thanks its partners and advocates for making their voices heard to stop many harmful proposed changes from going into effect.