August 09, 2018
2 min read

ACR condemns CMS decision to allow step therapy for Part B drugs

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David Daikh

The American College of Rheumatology has issued a statement expressing disappointment with the recent CMS decision to allow Medicare Advantage plans to adopt step therapy for Part B drugs.

According to the ACR, the change threatens patient access to drugs covered under Medicare Part B by placing control over treatment plans in the hands of insurance companies.

“Put simply, this policy change is a gross affront to America’s sickest Medicare patients — individuals living with diseases like inflammatory arthritis and cancer — who depend on timely access to safe, affordable and high-quality treatments,” ACR president David Daikh, PhD, MD, said in the statement. “Utilization management techniques like step therapy prevent and delay important treatments for rheumatic disease patients, which can result in irreversible joint or organ damage. At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will make it much more difficult for patients to get this treatment in time. We urge CMS to reconsider this policy and ensure that all Americans continue to have access to the most appropriate and effective therapy as determined by their health care team.”

On Aug. 7, CMS issued a memo to Medicare Advantage plans that rescinded a Health Plan Management System memo from Sept. 17, 2012 titled “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services,” and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 Jan. 1, 2019.

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 calls step therapy a “troubling practice” that forces patients to try therapies preferred by insurance companies prior to approval for therapy prescribed by the physician, even when the physician questions the other therapy’s efficacy.

The ACR issued comments to CMS in July that urged policymakers to protect patient access to Part B therapies and focus instead on the cost burden of developing alternative payment models, expanding patient access to information on cost and coverage, and improving the FDA’s ability to bring safe and effective biosimilars to market, according to the statement. The society has also advised CMS that any proposed changes go through the formal rulemaking process to give patients and health care providers a voice in the decision.

“A change this seismic — one that has significant consequences for patient access to life-saving drugs — should go through the formal comment and rulemaking process,” Daikh said. – by Stacey L. Adams