Maintain the six protected classes in Medicare Part D formularies

PAN’S POSITION

The six protected classes in Medicare Part D formularies must be protected to shield patients from substantial financial burdens.

To ensure Medicare Part D beneficiaries with certain health issues receive the care they require, the Centers for Medicare & Medicaid Services (CMS) states that all Medicare Part D plans must include at least two drugs in each of the six protected classes on their formularies.  

The six protected classes are 1) anticonvulsants, 2) antidepressants, 3) antineoplastics, 4) antipsychotics, 5) antiretrovirals, and 6) immunosuppressants. These drugs include patients treated for epilepsy, mental illness, cancer, HIV-AIDS, and organ transplants.

CMS established the protected classes to safeguard patients who need certain life-sustaining or life-changing medications and ensure they have access to those treatments. Legislative or regulatory changes to the six protected classes would erode essential patient protections and impose a substantial financial burden on beneficiaries with serious and complex health conditions. 

Many beneficiaries who rely on protected class drugs have complicated comorbidities, which often necessitate a nuanced treatment. Patients may require multiple drugs in one class or other supportive therapies that would be adversely impacted by protected class restrictions or exclusions.  

Recognizing the unique medical challenges of beneficiaries utilizing these medications, Congress and CMS have repeatedly affirmed the protected classes, noting that policy changes would weaken vital patient access protections.