August 17, 2018
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ACR President Discusses Step Therapy Concerns With HHS Secretary

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David Daikh

American College of Rheumatology President David Daikh, MD, PhD, met with HHS Secretary Alex Azar on Wednesday to discuss concerns regarding a new CMS policy to allow Medicare Advantage plans to adopt step therapy for Part B drugs, according to a statement from the group.

In the ACR statement, Daikh said Azar was willing to issue clarifying language to Medicare Advantage plans that would sharpen the definition of “grandfathering.” Daikh added that the ACR hopes such a clarification will guarantee that patients currently on stable treatment regimens will be shielded from step therapy should they switch between Medicare Advantage plans.

“Such a clarification should also explain that if a patient has previously been through step therapy to arrive at an effective medication under a different health plan, they will not be subject to step therapy again when they switch plans,” Daikh said in the statement. “Similarly, if a patient goes into remission and is able to stop taking a drug, but later needs to go back on to treatment, they will not be subject to step therapy again. We believe the aforementioned clarification would be a positive step in protecting our patients’ ability to continue with therapies that work, and urge HHS to move swiftly to provide that guidance.”

ACR President David Daikh, MD, PhD, met with HHS Secretary Alex Azar on Wednesday to discuss concerns regarding a new CMS policy to allow Medicare Advantage plans to adopt step therapy for Part B drugs.
Source: Shutterstock

Daikh added that he hopes HHS will provide additional information regarding how the policy will affect patients who are transitioning to Medicare.

The new CMS policy, issued on Aug. 7 as a memo to Medicare Advantage plans, revoked a Health Plan Management System memo from Sept. 17, 2012, titled “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services.” It also issued new guidance that will allow Medicare Advantage plans to use step therapy for Part B drugs starting Jan. 1, 2019.

The ACR responded 2 days later, condemning the new policy and arguing that the change threatens patient access to drugs covered under Medicare Part B by placing control over treatment plans in the hands of insurance companies.

“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,” Daikh said in the latest statement.

He added that although he and the ACR remained concerned about the new policy increasing provider burden, he is encouraged by HHS’s “willingness to accept input and proposals on how to reduce” that burden.

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“Further, we appreciate the administration’s expressed willingness to engage with the provider community regarding the appeals process and the value of defining clinically appropriate treatment pathways as part of step therapy,” Daikh said in the statement. “We hope that the administration will consider making the prior authorization and appeals process in Medicare Advantage more transparent and streamlined, as this is critical for patient access. While we continue to have concerns about the impact of this policy on our rheumatology patients’ ability to access timely and effective therapies, I want to thank Secretary Azar and his staff for engaging with ACR leaders and the rheumatology provider community on these issues.” – by Jason Laday