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ACR renews warning against step therapy for Part B drugs
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The American College of Rheumatology has renewed its call of concern over a recent CMS policy allowing Medicare Advantage plans to incorporate step therapy for Part B drugs, arguing that officials should institute a series of safeguards and exceptions for physicians and patients.
“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,” Paula Marchetta, MD, MBA, president of the ACR, said in a statement released Thursday. “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.”
In August, CMS issued a memo to Medicare Advantage plans that rescinded a Health Plan Management System memo from Sept. 17, 2012, titled “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services,” and issued new guidance that will allow Medicare Advantage plans to use step therapy for Part B drugs starting this year. The new policy officially went into effect on Jan. 1.
According to the letter, the new guidance acknowledges step therapy as a utilization management tool that will “help achieve the goal of lower drug prices while maintaining access to covered services and drugs for beneficiaries.”
However, the ACR said the policy could potentially expose patients to harm, often leads to delays in health care access, and undermines clinical expertise and evidence-based treatment.
In comments submitted to CMS, the ACR urged the government to establish exceptions to the step therapy policy for Part B drugs in certain situations, such as when the insurance-preferred treatment is contraindicated for a patient’s specific condition, or when a provider determines that a treatment is likely to be ineffective or harmful.
In addition, the ACR is promoting a series of safeguards, which it says may mitigate the potential harms of step therapy in Medicare Advantage plans, including:
- Clearly establish providers, rather than insurance companies, as the authority of whether a patient “fails” a treatment;
- Require plans to disclose that Part B drugs may be subject to step therapy in annual legal notices and documents;
- Establish a 365-day “lookback” period for Part B treatments, rather than the currently policy of 108-day periods for Medicare Part D plans;
- Prevent plans from using step therapy through prior authorization or any other different utilization management process; and
- Increase monitoring of utilization management practices, and require all denials to include a clinical rationale for the decision, while also informing patients of their right to an appeal.
In the same statement, the ACR also commended CMS for its changes to the Medicare Part D program requiring that drug pricing information and lower-cost therapeutic alternatives be included in the plan’s Explanation of Benefits document. According to the ACR, this policy bans “gag clauses,” which prevent pharmacies form disclosing whether a drug’s cash price is lower than the price with insurance. The group further urged CMS 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,” Marchetta said in the release. “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.” – by Jason Laday