Administration preserves Medicare’s protected classes of drugs

The Centers for Medicare and Medicaid Services (CMS) released a final rule that upholds the existing rules on the six protected classes of drugs in the Medicare Part D program. With this final rule, the administration is not proceeding with proposed changes to the protected classes that the American Kidney Fund (AKF) and many other patient and chronic disease organizations had cautioned would hinder patient access to critical medications. AKF issued a press release commending the administration for its decision.

The Medicare Part D prescription drug program requires plans to include on their formularies, with limited exceptions, all drugs for six classes (aka the protected classes), including immunosuppressants for the treatment of transplant rejection. Late last year, CMS proposed new exceptions to the protected classes policy that would have given plans more flexibility to use utilization management tools such as prior authorization and step therapy for protected class drugs, even if a patient is already on a stable drug regimen. It also would have allowed plans to exclude from their formulary protected class products that have changed their formulations or that have increased in price beyond a CMS-defined threshold.

AKF raised concerns in our comment letter to CMS that the proposal would hinder access to clinically-appropriate medications and jeopardize the health of patients with chronic conditions. For transplant patients already on a stable drug regimen, there could be serious risks to their health and donated organ if they now had to undergo step therapy requirements, or if a prescribed drug was removed from their plan formulary.

In addition to our comments, AKF engaged our Ambassadors to contact their Members of Congress and ask them to tell CMS to preserve Medicare’s protected classes. AKF also worked with a broad coalition of other patient and disease organizations to provide a united voice for people with serious health conditions who would be adversely affected by the proposal.

We would like to thank all the AKF Ambassadors who took action on this issue. With the administration’s decision to maintain Medicare’s protected classes, the patient voice was heard.

Posted: | Author: AKF Staff