WASHINGTON — Are Medicare Advantage (MA) plans allowed to require patients to go through “step therapy” to get a medication or treatment they need? Yes — for now — but physician groups are trying to change that.
“On August 7, 2018, CMS (the Centers for Medicare & Medicaid Services) issued a memo to MA plans that rescinded the September 17, 2012 HPMS [Health Plan Management System] memo Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services and issued new guidance allowing MA plans to use step therapy for Part B drugs, beginning January 1, 2019,” a group of 58 physician and healthcare organizations wrote in a letter to Health and Human Services Secretary Xavier Becerra on April 22.
“We were disappointed that the previous administration removed this important patient protection. Step therapy, also known as ‘fail first,’ is utilized by health plans to determine coverage and requires that patients fail on an insurer’s preferred medication before the therapy prescribed by their health care provider is covered. Step therapy frequently delays or disrupts continuity of care and threatens outcomes for patients. Stopping and restarting certain medicines may cause the treatments to fail due to immunogenicity or cause dangerous reactions when the medication is re-initiated,” the letter stated.
“While a drug or therapy might be generally considered appropriate for a condition, individual patient issues — the presence of comorbidities, potential drug-drug interactions, or patient intolerances — may necessitate the selection of an alternative drug as the first course of treatment,” the letter continued. “Step therapy requirements often fail to recognize such considerations, resulting in delays in getting patients the right treatment at the right time. A patient’s health care provider is in the best position to assess their patients’ medical needs.”
To date, the Biden administration hasn’t acted on the letter, and CMS did not respond by press time to a request for comment on the issue. But the American Academy of Ophthalmology (AAO), one of the signers of the letter, reported that it has a meeting scheduled with a CMS official on the matter. “The academy has also had conversation with CMS on step therapy policies in relation to recent Avastin [bevacizumab] supply chain disruptions,” the AAO wrote in an email to MedPage Today, referring to the anti-VEGF medication used to treat retinopathy and other eye conditions.
“Step therapy for anti-VEGF treatment in Medicare Advantage beneficiaries is now required by most MA plans,” AAO spokesperson George Williams, MD, noted in the email. “Although off-label bevacizumab is an effective treatment for many patients and, in fact, is used by ophthalmologists nearly 45% of the time in MA beneficiaries, there are clinical situations where other FDA-approved treatments are preferable.”
“Step therapy delays access to FDA-approved treatments that are immediately available to Medicare fee-for-service patients,” he continued. “Since a larger share of Black and Hispanic than white beneficiaries are enrolled in MA plans, such access issues may contribute to disparities in care. The AAO believes that treatment choices are best made by the physician and patient, and that all Medicare beneficiaries should have immediate access to all FDA-approved treatments.”
The use of step therapy also poses problems for gastroenterology patients, according to James Weber, MD, president of the Digestive Health Physicians Association, another signatory to the letter. “For my patients with inflammatory bowel diseases like Crohn’s disease and ulcerative colitis, step therapy can lead to serious complications while waiting for the right medication, such as emergency department visits, hospitalization, and even surgery,” Weber wrote in an email. “Patients rightly expect me to use my best judgment when deciding what medications to prescribe. We should end the practice of allowing insurers to mandate that my patients try medications I know will not work before allowing them to take the drug I judge to be most effective.”
The American Academy of Neurology, which also signed the letter, noted in an email that step therapy is a “major burden” on neurologists, one that “gets in the way of providing the highest possible neurologic care for patients. We believe step therapy reform, like with other burdensome issues such as prior authorization, should be a priority.”