In late February 2021, Senators Lisa Murkowski, Maggie Hassan, Bill Cassidy, Jacky Rosen, and nine other bipartisan co-sponsors introduced the Safe Step Act of 2021, which would put limits on the use of step therapy by insurance companies. Step therapy is the requirement that patients try – and fail – treatments that are preferred by their insurance company and pharmacy benefits manager before they can receive therapy as prescribed by their doctor.
The Safe Step Act would implement transparency guidelines to prevent inappropriate use of step therapy in employer-sponsored health plans and create a clear process for patients and doctors to seek reasonable exceptions to step therapy.
Included in the legislation are five situations in which a patient would be excepted from step therapy: (1) if the patient has already tried and failed the insurer-preferred drug; (2) if delayed treatment will cause irreversible consequences; (3) if requiring the insurer-preferred drug will cause harm to the patient; (4) if the required drug will prevent a patient from working or fulfilling activities such as eating, grooming, dressing, bathing and other Activities of Daily Living as defined by the Centers for Medicare and Medicaid Services (CMS); or (5) if the patient is stable on the prescription drug selected by their provider, and that drug has been covered by their previous insurance plan.
Insurance plans would be required to respond to all exception requests within 72 hours of submission, unless the patient’s life is at risk, in which case the response is due within 24 hours.
The American College of Rheumatology has applauded the introduction of the Act, “Ensuring timely access to clinically appropriate treatment is critical to the well-being of millions of Americans living with rheumatic diseases. Unfortunately, far too many patients encounter delays in accessing needed care due to restrictive insurer practices like step therapy. The Safe Step Act would put reasonable limits on insurers’ use of step therapy and create a clear and transparent process for patients and physicians to seek exceptions. We thank lawmakers for introducing this bill and urge Congress to pass this legislation without delay.”
The bill has been referred to the Senate Committee on Health, Education, Labor, and Pensions for further action.
A version of the Safe Step Act is expected to be introduced in the House of Representatives later this month by Reps. Raul Ruiz, MD (D-CA) and Brad Wenstrup, DPM (R-OH), two physicians who have encountered step therapy in their own practices. Both lawmakers have previously sponsored similar legislation in prior sessions of Congress.