As part of the Safe Step Act Ad Hoc Coalition, SDPA signed an informational letter addressed to the Centers for Medicare & Medicaid Services (CMS) related to the use of step therapy in plans that provide Essential Health Benefits (EHB).

The Coalition defines step therapy as a complex form of prior authorization (PA) in which health insurers require patients to try and fail one or more insurer-preferred medications before the insurer will cover the medication initially prescribed and agreed upon by the patient and their provider. Because it can take several months for patients to prove failure, medically inappropriate step therapy delays access to needed care and can result in devastating health outcomes.

The letter, signed by 83 other patient and provider advocacy organizations, recommends the following general reforms:

• Ensure health plans offer a transparent step therapy exceptions process accessible to patients and providers.
• Establish medically reasonable circumstances when a health plan should grant an exception request.
• Require health plans to respond to a step therapy exception request within 24-72 hours.

To date, 35 states across the nation have passed step therapy reform laws. However, many enrollees in plans that provide EHB remain without protections. To address this gap, the coalition strongly recommends that CMS update the exceptions process outlined in section (c) of 45 CFR §156.122 to clarify that it applies to utilization management, including insurance-mandated prior authorization and step therapy. The letter, dated Jan. 31, 2023, may be accessed here.