CMS Proposes Changes to Protected-Class Drugs

Last week, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would allow Part D and Medicare Advantage plans to use additional tools to reduce prescription drug prices. Some of these tools rely on weakening the protections for consumers who take certain medications in what are known as the “protected classes.”

In general, plans that offer prescription drug coverage must include on their formulary, or list of covered drugs, at least two medications in each “class,” or type of drug. They must, however, include all medications available in certain protected classes – including anti-depressants, antipsychotics, anticonvulsants, immunosuppressants for transplant rejection, antiretrovirals and antineoplastics. The proposed rule would allow plans to use more utilization management controls, like step therapy and prior authorization for medications in these classes and would allow plans to remove medications in these classes from their formularies in some circumstances.

We are troubled by this proposal – the protections for these categories of drugs were put in place because the medications are not easily substituted and/or because interruptions in drug therapies could have significant individual and public health consequences. While we appreciate the need to control drug pricing increases, impeding access to needed medications cannot be the mechanism to do so.

The proposed rule is not all bad though. Other aspects include improvements to e-prescribing, expanded information included in beneficiary notifications about lower-cost medication alternatives, and implementing statutory changes that preserve the right of pharmacists to notify patients of lower pricing options.

We will be responding to this proposed rule through the public comment process.

Read the proposed rule.