ACR Calls for Safeguards Against Step Therapy for Part B Drugs

The ACR is urging CMS to adopt safeguards to protect Medicare Advantage beneficiaries from step therapy.

The American College of Rheumatology (ACR) has expressed continued concern with the recent policy from the Centers for Medicare and Medicaid Services (CMS) allowing Medicare Advantage plans to use step therapy for Part B drugs.

Step therapy uses management techniques that force patients to try medications preferred by their insurance company before approving the medication prescribed by a physician. The practice can delay access to appropriate treatment and undermine the judgment of healthcare providers. The ACR encourages CMS to make it clear that a patient’s provider must determine whether a patient “fails” a treatment, and that this decision must not be made by the insurance company.

The ACR also urges CMS to establish safeguards before moving forward with the step therapy policy. Exceptions to step therapy should be made if the treatment is contraindicated for a patient’s specific condition; if the provider determines that the treatment is likely to be ineffective, likely to cause a harmful reaction, or impede the patient’s ability to perform daily activities or responsibilities or adhere to the treatment plan; or if a provider believes the new treatment will endanger the patient’s life.

The policy should also require Medicare Advantage plans to disclose that Part B drugs may be subject to step therapy in the plan’s Annual Notice of Change and Evidence of Coverage Documents.

The ACR also urges the implementation of a 365-day “lookback” period for Part B therapies, and suggests that the policy prevent plans from implementing step therapy with a different utilization management process such as prior authorization. The CMS should also require that all denials include the clinical rationale for the decision and clarify the beneficiary’s appeal rights.

“While we appreciate the agency’s efforts to make prescription medications more affordable, we have serious concerns regarding the decision to allow Medicare Advantage plans to implement step therapy for Part B drugs and cross-manage Part B and D drug utilization,” stated Paula Marchetta, MD, MBA, president of the ACR, in a press release. “We begin the 2019 benefit year with no safeguards in place to protect beneficiaries from changes that could seriously threaten their access to needed medications. At a minimum, CMS should immediately issue updated guidance that will clarify patient protections for the current year and beyond.”

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The CMS has also made changes to the Part D program, and now requires that drug pricing information and lower-cost therapeutic alternatives be included in the plan’s Explanation of Benefits document. The ACR has commended CMS for banning “gag clauses” that prevent pharmacies from disclosing whether the cash price of a drug is lower than the price with insurance. They also urged the agency to consider establishing common definitions for terms used during plan negotiations with Pharmacy Benefit Managers.

“The ACR is dedicated to ensuring that rheumatologists and rheumatology care professionals have the resources they need to provide patients with appropriate, high-quality care and that safe and effective treatments be available to all patients at the lowest possible cost,” Dr Marchetta concluded. “We appreciate the opportunity to respond to this proposed rule and look forward to serving as a resource for the agency as it continues its work.”

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ACR Responds to CMS Medicare Part D and Medicare Advantage Proposed Rule [press release]. Atlanta, Georgia: American College of Rheumatology. Published January 24, 2019. Accessed January 24, 2019.