Aimed Alliance Asks CMS to Reinstate Six Protected Classes Requirements


On January 28, 2021, Aimed Alliance submitted a letter requesting that the Centers for Medicare & Medicaid Services (CMS) reverse recent changes to the Part D Modernization Model for Calendar Year 2022 (PDM Model). Currently, Part D sponsors are required to include on their formularies “all or substantially all drugs” within six categories or classes of drugs (i.e., anticonvulsants, immunosuppressants, antidepressants, antipsychotics, antineoplastics, and antiretrovirals), referred to as the “Six Protected Classes.” Under the PDM Model, participating Part D sponsors will be permitted to treat five of the six protected classes as they would other Part D drug starting in 2022, and the sixth class—antiretrovirals—would also lose its protections starting in 2023. The Six Protected Classes include conditions that often require specialized treatment that is targeted to a patient’s specific needs, and the treatments within these classes are often not interchangeable, meaning that if a stable patient is switched, that patient may not achieve the same success on the new medication. Loss of access to a medication or being switched onto something less effective can result in dangerous side effects for the impacted conditions.

Additionally, these changes were enacted without (1) evaluating and ensuring compliance with scientific evidence and medical standards of practice and (2) public notice and comment, both of which violate the Social Security Act. Public notice and comment is particularly important as previous public comments proved effective in preventing changes to the Six Protected Classes and ensured that patients continued to have important Part D protections. Read our letter here.


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