Academy-Led Group to CMS: End Step Therapy in Medicare Advantage

In our latest effort, the Academy urged the Centers for Medicare & Medicaid Services (CMS) to “move swiftly to reinstate the step therapy prohibition in Medicare Advantage plans for Part B drugs.” Although the agency seemed open to stricter guardrails in recent interactions, the Academy, as part of a broad effort, is leading another push for a full ban on the cost-cutting practice.

Nearly 60 patient and provider groups, including the American Medical Association and Medical Group Management Association, joined our call for action in an Academy-led letter to CMS. 

As we reiterated in the Nov. 23 letter (PDF), step therapy in Medicare Advantage plans has caused “clear instances of patient harm [including] patients becoming legally blind, or experiencing long term hospitalizations, infections, increased disease activity and disability.”

Our letter reinforces the message we sent in an Academy-led meeting with CMS in September, in which we convened several patient and provider groups to share how step therapy harms patients. CMS requested recent examples after dozens of societies signed an Academy-led letter in April opposing the practice. 

George A. Williams, Academy senior secretary for advocacy, said it’s also an issue of health equity. Medicare Advantage plans disproportionately serve patients from minority groups, compared to Medicare fee-for-service.

So long as Medicare Advantage plans continue to allow step therapy, patients treated under these private, for-profit, plans don’t get the same health care as those in fee-for-service. That practice violates the law.

“If you or your mother came to me and you had already lost vision in one eye, and you had advanced disease in your other eye requiring immediate treatment, I think you would want all your treatment options available. I know I would,” Dr. Williams said.

Medicare Advantage patients don’t have all those options, and profit-motivated insurers continue to interfere in the physician-patient relationship, including clinical decision-making.

Just weeks after the Academy and the American Society of Retina Specialists (ASRS) told CMS that Medicare Advantage plans are putting profits over patients, the agency in November put some restrictions in place to keep ophthalmic patients safe from “potentially dangerous” biosimilar drugs.

Agreeing with our concerns, CMS stopped the insurers from requiring off-label biosimilars Zirabev and Mvasi as substitutes for Avastin in treating eye conditions in their step therapy programs.

In a letter to Medicare Advantage plans, CMS said that “Part B step therapy programs may include a drug supported only by an off-label indication if the off-label indication is supported by widely used treatment guidelines or clinical literature that CMS considers represent best practices.”

Although CMS took this positive action, it reiterated that biosimilars can be used in step therapy programs in Medicare Advantage. We strongly believe that step therapy should not be allowed at all.

CMS prohibited step therapy from 2012 to 2018, but reinstated it in 2019. To reimpose a step-therapy ban, CMS would likely have to include the change in a formal rule.