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Public Policy Newsletter Article

Successful Advocacy Leads to Withdrawal of Damaging Six Protected Classes Rule

  • 2021-03-25T15:00:00.000+0000
  • Author: Laure Fabrega

On March 16, the Centers for Medicare and Medicaid Services (CMS) announced the withdrawal of its proposal to waive the Medicare policy that requires coverage of all (or substantially all) drugs within the six protected classes, which would have treated these classes of clinical concern the same as other drugs. The change had been announced in the CY 2022 Part D Payment Modernization Model RFA, issued on January 19, 2021 and received significant pushback from stakeholders.

Protected classes in Medicare are classes of therapeutics for which Medicare Part D plans are required to cover all drugs. The protected classes are: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants; 5) antiretrovirals; and 6) antineoplastics (for cancer patients). Protected classes were identified when Medicare Part D was created to ensure that the most at-risk patients in the healthcare system have access to the right treatment for them. For those conditions, drugs are often not interchangeable and individuals tend to react differently to them, often requiring patients to be on several courses of treatment before finding the right one.

Biocom California, along with many industry, provider and patient groups, strongly opposed the measure and launched several advocacy efforts to have the policy removed. Biocom California and other life science associations sent a letter to CMS on February 17 urging the agency to withdraw the provision. Biocom California also worked with California Representatives Barbara Lee and Grace Napolitano on a congressional sign-on letter to CMS also objecting to the policy. The letter was sent on March 3 with 67 co-signers.

This was the third time in recent years (2014, 2019, and 2021) that CMS had tried to limit coverage of drugs in the protected classes, and each time, it is pushback from stakeholders and Congress that led to CMS withdrawing the policy. Policies limiting coverage of these medicines will deny patients access to much-needed medicines and have catastrophic effects on patients. Biocom California will continue to advocate against similar proposals in the future.