S. 2903: Safe Step Act

The Safe Step Act is a proposed legislation aimed at modifying health insurance policies related to prescription drugs and their approval process, specifically focusing on what is known as "medication step therapy protocols." Here's a breakdown of what the bill entails:

Purpose of the Bill

The main goal of the Safe Step Act is to mandate that group health plans and health insurance issuers create a structured process that allows participants (the insured individuals) and their prescribing healthcare providers to request exceptions to step therapy protocols.

What Are Medication Step Therapy Protocols?

Step therapy protocols are procedures where a health plan requires patients to try one or more alternative medications (often preferred drugs) before covering the specific medication initially prescribed by their healthcare provider. These protocols can sometimes delay access to the most appropriate treatment.

Key Features of the Safe Step Act

• Exceptions Process: The act requires health plans to establish a clear, transparent, and prompt process through which patients and their prescribers can request exceptions to step therapy protocols.
• Criteria for Exceptions: The legislation outlines specific situations in which an exception to the standard protocol should be granted. These include instances where:
  • The prescribed drugs have been ineffective.
  • Delaying treatment would have severe consequences for the patient.
  • The required medications could cause adverse reactions.
  • The patient is already stable on the prescribed drug.
• Standardized Process: Health plans must provide a standardized form for exception requests that is accessible both in paper and electronically. They must also allow a participant to be represented by a third party if needed.
• Information Availability: Health plans must make information about the exceptions process readily available to participants, including necessary forms and contact information.
• Timeliness of Responses: The act specifies that health plans must respond to exception requests within certain timeframes—72 hours for standard requests and 24 hours for urgent cases affecting the participant's health.
• Duration of Approval: If an exception is granted, the coverage must be maintained for at least one year.
• Reporting Requirements: The act requires health plans to report data on exception requests, approvals, and denials to the Secretary of Labor at least once a year after enactment, which will help track the effectiveness and use of the exceptions process.

Enforcement and Implementation

The provisions of the Safe Step Act would take effect six months after its enactment. The Secretary of Labor is tasked with creating regulations to ensure the law is properly implemented.

Relevant Companies

• CVS: As a major pharmacy benefit manager, CVS could see changes in its operations due to the required exceptions process for medication step therapy protocols.
• UNH: UnitedHealth Group might need to adjust its health plan offerings to comply with the new exceptions processes, potentially impacting its cost structure and customer service operations.
• ANTM: Anthem, as a major health insurer, will be required to adapt its policies and processes in alignment with the requirements of the Safe Step Act.