Partnership Applauds Secretary Azar for Outlining Concerns with Step Therapy

The Partnership for Part D Access applauded HHS Secretary Alex Azar for his remarks in a speech today before the American Medical Association (AMA) in which he acknowledged the dangers inherent in requiring step therapy for patients who are already stabilized on an effective regimen of medications. Interestingly, his remarks seemed to run counter to his agency’s current proposal to weaken Medicare’s successful “six protected classes” policy. Given today’s statement, the Partnership urges the Secretary to abandon the administration’s proposal, which countless stakeholders would agree is “penny-wise and pound-foolish.” 

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​Under current law, Medicare’s six protected classes policy ensures that patients with the most complex conditions (ex. mental health, cancer, HIV, organ transplants, epilepsy, etc.) will have access to a broad spectrum of medications. Under current law and agency regulations, patients who are so-called “new starts” — meaning they are not stable on a drug regimen already — may be subject to step therapy and prior authorization, requiring them to try alternative therapies or gain their insurer’s approval before filling a prescription for a certain drug. However, insurance plans currently cannot require these utilization management tools for patients who are already stabilized on a particular treatment within the protected classes. This is true both when a patient enrolls in Medicare for the first time and when a patient changes from one insurance plan to another.
 
In November 2018, the administration released a proposed rule that would allow Medicare drug plans to implement new utilization management tools on the six protected classes, including more restrictive step therapy policies. Under the new policy, starting in 2020, plans may use step therapy and prior authorization and for protected class drugs, even if the patient is already stabilized on a particular treatment regimen.
 
As Secretary Azar acknowledged in his speech today, there are significant drawbacks with disrupting treatment for patients who are effectively managing their chronic conditions:

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen. This is not just potentially injurious to their health; it’s also penny-wise and pound-foolish. We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health—and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now, and we would greatly appreciate your bringing other issues like that to our attention."

​In response to the administration’s proposal to alter Medicare’s six protected classes, thousands of individuals from across the country and hundreds of patient advocacy groups expressed their opposition. The six protected classes policy stands among the preeminent patient protections in Medicare Part D, and in light of today’s remarks, we hope the Secretary will quickly heed their concerns.