
Washington, DC (KINY) - U.S. Senators Lisa Murkowski, Maggie Hassan (D-NH), Roger Marshall (R-KS), Jacky Rosen (D-NV), along with 14 of their colleagues, introduced the Safe Step Act of 2023, a bill that places reasonable limits on the use of “step therapy,” and works to improve access to safer and more transparent treatments for patients.
Step therapy, also known as “fail first,” occurs when a patient is required to try and fail on a lower cost drug before they are allowed to access the drug originally prescribed by their physician. This method has the potential to harm patients, in part due to delayed access to the most effective treatments, severe side effects, and irreversible disease progression, creating additional frustration for patients as they seek treatment.
Specifically, the Safe Step Act would amend the Employee Retirement Income Security Act (ERISA) to require group health plans to provide an exception process for any medication step therapy protocol, tools used by health plans to control spending on patient’s medications, to help ensure patients are able to safely and efficiently access treatment. The bill does not ban step therapy, instead placing reasonable limits on its use and creates a clear process for patients and doctors to seek exceptions and accelerated approval if necessary.
For full text of the bill, click here.
“Patients and their families shouldn’t have to deal with a complicated process that threatens their health due to inefficient and burdensome requirements associated with step therapy. I’m proud to lead on this bipartisan effort to improve patient health outcomes and reduce barriers to getting the right medications and treatments they need—while also avoiding potentially dangerous side effects or delays in access to care,” Senator Lisa Murkowski said. “No one should have to take medications that they have previously failed on or that their provider knows isn’t best treatment to comply with step therapy. Current step therapy practices simply don’t work for many patients, and this bill works to address that very issue.”
“I am a person with Parkinson's disease. As part of my treatment, my movement disorders specialist recommended a drug to help with migraines. However, she told me that my insurance may not pay for it unless I had previously tried and failed to see improvement with two older migraine drugs. She also advised that she would have to personally prescribe the older medications, even though a different neurologist had prescribed them for me in the past. Ultimately, I was able to get the newer medication covered, but the extra hoops and delay caused a lot of stress and uncertainty,” Kerry Howard, Juneau, Alaska, said
Bill Highlights:
Establishes a clear exemption process: The Safe Step Act requires insurers implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol.
Outlines 5 exceptions to fail first protocols: Requires that a group health plan grant an exemption if an application clearly demonstrates any of the following situations:
• Patient already tried and failed on the required drug
• Delayed treatment will cause irreversible consequences
• Required drug will cause harm to the patient
• Required drug will prevent a patient from working or fulfilling Activities of Daily Living
• Patient is stable on their current medication
Creates Response Timeframe for Exemption Requests: Requires a group health plan respond to an exemption request within 72 hours in all circumstances, and 24 hours if the patient’s life is at risk.
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