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Public Policy Newsletter Article

Biocom CA Advocates to Preserve Medicare Protected Classes

  • 2021-02-25T16:00:00.000+0000
  • Author: Isabel Omer

In January 2021, CMS released the Part D Payment Modernization Model, which changed coverage requirements for protected classes.

Protected classes in Medicare are classes of therapeutics where patients may need access to more than two different drugs. The protected classes are: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants; 5) antiretrovirals; and 6) antineoplastics (for cancer patients). These classes include some of the most at-risk patients in the healthcare system. Their origin goes back to the Medicare Modernization Act of 2003, which created the Medicare Part D Program. Medicare Part D plans are required to cover all drugs in the protected classes.

This new rule would allow Part D sponsors to treat five of the six protected classes the same as other Part D drugs starting in 2022 (2023 for antiretrovirals) and ultimately cover fewer medications. CMS would also allow plans to cover only one drug per protected class. Fewer covered medications could have catastrophic effects on patients.

Biocom California joined state bioscience associations across the country in sending a letter to CMS condemning this regulation. The letter states that allowing for flexibility with respect to the six protected classes and allowing Part D plan sponsors to limit drug coverage to at least one drug per class are key concerns for both industry and patients. Decreasing the number of covered drugs for Medicare Part D is especially concerning because many drugs for patients in protected classes are not interchangeable and individuals react differently to them.

Biocom California is also educating the California delegation about the importance of preserving coverage for the drugs in the protected classes and urging Members of Congress to sign on a group letter led by California Congresswomen Barbara Lee and Grace Napolitano urging CMS to withdraw the rule.