AKF expresses concern on proposed changes to Medicare’s protected classes of drugs

The American Kidney Fund (AKF) submitted a comment letter to the Centers for Medicare and Medicaid Services (CMS) that voiced our concern on proposed changes to the six protected classes of drugs in the Medicare program. AKF has also signed-on to coalition letters that were joined by many other organizations representing patients, caregivers, individuals with disabilities and people with chronic diseases.

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): antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics. The six protected classes ensure that beneficiaries with serious conditions such as cancer, HIV/AIDS, epilepsy, Parkinson’s Disease, lupus, organ transplants and mental health conditions have access to needed medications that are right for them.

However, CMS has proposed new exceptions to the protected classes policy that would grant plans greater 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. Prior authorization requires providers to obtain authorization from the plan before prescribing a medication to a patient; step therapy requires a patient to try a less expensive medication first, and if it proves ineffective then another drug can be prescribed. CMS also proposed allowing 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.

In our letter, AKF raised concerns that these proposed changes would hinder access to clinically-appropriate medications and jeopardize the health of patients with chronic conditions. We focused our comments on the effect on transplant patients, explaining that they work closely with their providers to find the right drug regimen that mitigates serious side effects while providing adequate immunosuppression to prevent organ rejection. If a transplant patient on a stable drug regimen must deal with new prior authorization or step therapy requirements, or the removal of a prescribed medication from their plan formulary, there would be serious risk to the donated organ and the patient’s health. Given these concerns, we urged CMS not to finalize its proposal on protected class drugs.

We have also set up an action alert for AKF Ambassadors to contact their Member of Congress, asking them to tell CMS to preserve Medicare’s six protected classes. If you would like to take action, please click here. 

Posted: | Author: AKF Staff