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S. 464: Safe Step Act

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Feb 25, 2021.

Safe Step Act

This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. 

A request for such an exception to the protocol must be granted if (1) an otherwise required treatment has been ineffective, (2) such treatment is expected to be ineffective and delaying effective treatment would lead to irreversible consequences, (3) such treatment will cause or is likely to cause an adverse reaction to the individual, (4) such treatment is expected to prevent the individual from performing daily activities or occupational responsibilities, (5) the individual is stable based on the prescription drugs already selected, or (6) there are other circumstances as determined by the Employee Benefits Security Administration.

The bill requires a group health plan to implement and make readily available a clear process for an individual to request an exception to the protocol, including required information and criteria for granting an exception. The bill further specifies timelines under which plans must respond to such requests.