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November 25, 2018

NPAF Statement on Proposed Changes to Medicare Protected Classes

The Department of Health and Human Services (HHS) announced proposed changes to alter rules around Medicare Part D’s “Six Protected Classes.”  If finalized, these changes could dramatically impact access to affordable medications and quality care for Medicare enrollees. We urge HHS to reject any proposed changes that would result in restricting benefits and undermining standards for patients nationwide.


CMS has long acknowledged that Medicare beneficiaries may need access to more than two different drugs within a therapeutic class. Currently there are six designated protected classes: anticonvulsants, antidepressants, antineoplastics (including many oral chemotherapy drugs), antipsychotics, antiretrovirals and immunosuppressants.


The proposed changes include excluding certain drugs from these formularies, as well as allowing greater use of prior authorization and step therapy. Not only will these changes result in financial burdens for patients but it will also place a significant administrative burden on plans that will assuredly experience an increase in appeals.  Further, patients who experience these frustrating and often lengthy delays in accessing the appropriate therapy may ultimately increase their use of other services, driving up costs and negating any potential savings.


We understand the need to increase the ability of plan issuers to negotiate lower drug prices. However, we caution HHS against attempting to achieve program savings by placing further burdens on patients. Instead, we look forward to working with HHS to achieve lower costs for patients through innovative policy solutions that engage the entire community.


NPAF’s submitted comments to CMS can be read here.