Earlier this year, physician groups petitioned the Department of Health and Human Services to reduce requirements that patients go through “step therapy” to get a needed treatment. As written in the letter, “On August 7, 2018, CMS (the Centers for Medicare & Medicaid Services) issued a memo to MA plans that rescinded the September 17, 2012 HPMS [Health Plan Management System] memo Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services and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.” The letter was signed by 58 physician and healthcare organizations and addressed to Health and Human Services Secretary Xavier Becerra.
Letter Specifics
“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.”
HHS Response
As recently reported by MedPage Today, a CMS official acknowledged it received the letter and stated “the agency appreciates — and is still reviewing — this important feedback from stakeholders essential to care. While CMS does not speculate on future plans as a matter of policy, the agency looks forward to collaborating with colleagues across healthcare.”
While noting the Biden administration hasn’t acted on the letter, MedPage Today also cited the American Academy of Ophthalmology (AAO), one of the signers of the letter, which said it has a meeting scheduled with a CMS official on the matter. Furthermore, the American Academy of Neurology (AAN), another signer of the letter, said 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.”