Senate Bill Seeks to Limit Use of Step Therapy in Employer Health Plans

Bipartisan legislation introduced earlier this month in the Senate would create 5 situations where a patient would be exempted from step therapy in employer-sponsored health plans, sometimes assailed as “fail first” policies by patients and providers.

Step therapy, along with prior authorization and formulary lists, are some of the tools used by payers in an effort to control skyrocketing drug costs. Patient groups and providers counter that they can delay care prescribed by a physician.

The Safe Step Act (S.464), sponsored by Sen. Lisa Murkowski (R-Alaska) and 13 other co-sponsors, including 5 additional Republicans and 8 Democrats, spells out 5 exemptions for patients by amending the Employee Retirement Income Security Act of 1974:

• If they have already tried and failed the preferred drug
• If delayed treatment will cause irreversible consequences or is expected to be ineffective based upon the documented physical or mental characteristics of the participant or beneficiary and the known characteristics of such treatment
• If requiring the drug preferred by the insurer will cause harm or adverse events to the patient based on “clinical, peer-reviewed evidence”
• If the preferred 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 CMS
• If the patient is stable on the prescription drug chosen by their physician, and that drug has been covered by previously “by any group health plan or health insurance issuer.”

Plans would be required to respond to all exception requests within 72 hours, or 24 hours if the patient’s life is at risk.

“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,” said Blair Solow, MD, a practicing rheumatologist and chair of the Government Affairs Committee of the American College of Rheumatology (ACR). “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 ACR said a version of the bill is planned to be reintroduced in the House of Representatives by Reps. Raul Ruiz, MD (D-California) and Brad Wenstrup, DPM (R-Ohio); the 2 lawmaker-doctors previously introduced the legislation in 2019.