The six protected classes in Medicare Part D formularies must be protected to shield patients from substantial financial burdens.
Legislative or regulatory changes to the six protected classes policy would erode essential patient protections and impose a substantial financial burden on beneficiaries with serious and complex health conditions.
Formulary changes to the six protected class policy would severely disrupt or deny care for millions of Part D beneficiaries. In 2021, Part D plans provided over 48 million people with a lifeline to affordable prescription drug access. Under Part D plans, six categories of drugs — known as the “six protected classes” — must cover “all or substantially all” of the drugs in those classes. These drugs include patients treated for epilepsy, mental illness, cancer, HIV-AIDS, and organ transplants. The Centers for Medicare and Medicaid Services (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.
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. Changes could also cause substantial anxiety and confusion for beneficiaries, who already must navigate significant financial and administrative hurdles.
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.