Step therapy, also known as “fail first” therapy, is not a new concept in healthcare. Originally introduced into the care process by health insurance plans, step therapy was aimed at lowering costs, improving quality of life, and ensuring that patients received the most preferred therapy. The process requires prior authorization by a patient’s health insurer to determine if the patient’s plan will cover a prescribed drug or require that the patient be treated first with another therapy. Historically, Medicare Advantage plans were not permitted to implement step therapy. However, in August 2018, the Centers for Medicare & Medicaid Services (CMS) issued a memo announcing new guidance that allowed Medicare Advantage plans to implement step therapy for Part B drugs effective January 1, 2019. This regulatory shift reversed a 2012 CMS Health Plan Management System memo stating that "plans were precluded from imposing additional requirements for access to certain Part B drugs or services, such as step therapy requirements."
More recently, in May 2019 CMS issued a final rule that expanded step therapy to Medicare Part B drugs but specifies that antineoplastics are still to be included among the “protected classes,” and that insurers could impose prior authorization and step therapy requirements for new patients only.
As cancer treatments have become increasingly targeted and complex, the potential for increased utilization of step therapy in oncology presents unique challenges for patients and providers. This lecture series explores the implications of implementation of step therapy in Medicare Advantage plans, which cover more than 20 million Medicare beneficiaries, on patient-centered cancer care delivery.