Rheumatology and Oncology Providers Voice Concern Over CMS Step Therapy Plan

Following the announcement made by CMS last week that it will allow Medicare Advantage (MA) plans to negotiate drug prices for physician-administered and other Part B drugs by allowing plans to use step therapy, many industry stakeholders have expressed concern.

Although the policy change was intended to cut out-of-pocket drug costs for patients, a number of organizations, including the American College of Rheumatology (ACR), have argued that step therapy can be harmful to patients with chronic conditions. On Wednesday, ACR met with HHS Secretary Alex Azar to discuss their concerns.

“While we support the goal of decreasing the cost of medications, the ACR has long opposed step therapy and other utilization management techniques that undermine the clinical judgement of providers, delay access to needed treatments, and put our patients’ health at unnecessary risk,” said David Daikh, MD, PhD, president of the ACR in a statement made following the meeting.

During the meeting, Daikh said, Azar seemed open to providing clarifying language about which patients will be subject to step therapy. ACR hopes that the clarification will allow patients currently stable on their treatment to not be required to undergo step therapy if they switch between MA plans. Additionally, ACR hopes HHS will clarify that if a patient has already been through step therapy and arrived at an effective medication, that that patient will not be subject to step therapy again.

Click here to learn more about ACR’s comments on the Trump administration’s drug pricing blueprint.

Oncology organizations have also voiced their concerns about the policy change. The Community Oncology Alliance’s (COA) president, Jeff Vacirca, MD, FACP, called the policy a “nightmare” for patients with cancer.

In a statement, he said that “CMS’ action is the antithesis of where personalized cancer treatment is going—it’s old-school, cookbook medicine that treats every patient as one-size-fits-all. It’s telling me to effectively sit back and let some middleman make treatment decisions for my patients.”

The American Society of Clinical Oncology (ASCO) echoed COAs apprehension. Monica Bertagnolli, MD, FACS, FASCO, president of ASCO, said in a statement, “In modern cancer care there is frequently a lack of interchangeable treatment options, and optimal care requires patient access to the most medically appropriate drug at the most opportune time based on the highest quality evidence.” She went on, “We strongly urge CMS to reverse this decision.”

While the organizations continue to oppose the rule and look for clarifications around what this will mean not only for patients but for their practices, Daikh said that he was encouraged by the administration’s willingness to accept input, and that he looks forward to continuing the dialogue on policy modifications that will improve patient access.