U.S. House and Senate Reintroduce the Safe Step Act

Portland, Oregon ­­-

The National Psoriasis Foundation (NPF) applauds the U.S. House and Senate for reintroducing the Safe Step Act in the 117th Congress. This legislation amends the Employee Retirement Income Security Act (ERISA) to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide a robust exception process for step therapy protocols.

S.464 is sponsored by Senators Lisa Murkowski (R-AK), Margaret Hassan (D-NH), Bill Cassidy (R-LA), and Jacky Rosen (D-NV). The House companion bill, H.R. 2163 is led by Representatives Raul Ruiz (D-CA-36), Brad Wenstrup (R-OH-2), Lucy McBath (D-GA-6), and Mariannette Miller Meeks (R-IA-2).

Step therapy is a tool used by health insurance providers to control spending on patient medications. A 2020 NPF survey found that 70% of people with psoriatic disease who take a biologic have experienced step therapy. While step therapy can be effective in containing the costs of prescription drugs, in some circumstances, it can have a negative impact on patients, including delayed access to the most effective treatment, severe side effects, and potentially irreversible disease progression.

Currently, when a health care provider prescribes a treatment, an insurance company may require the patient to try and fail on different treatments before they can access the one originally prescribed by their health care provider. This protocol is known as “step therapy” or “fail first.” These protocols do not consider the unique circumstances and medical history of the patient, often requiring a patient to use medications that previously failed to address their medical issue or could have dangerous side effects.

The Safe Step Act would require insurance providers to implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. Upon an exception request, insurers are required to reply within 24 hours for emergency requests, or within 72 hours for non-emergency exception requests.

Patients will be granted an exception if the patient has already tried the required treatment and it was discontinued due to lack of efficacy, if treatments are expected to be ineffective, if treatments are contraindicated or will likely cause an adverse reaction or harm to the patient, if the treatment has or will prevent the patient from fulfilling their responsibilities at work or performing daily living activities, or if the patient is stable with their current treatment that was covered by their previous insurance plan.

“The reintroduction of this commonsense legislation in the 117th Congress emphasizes the critical need for federal legislation that ensures patients receive the most medically appropriate treatment in a timely manner,” says Hannah Lynch, associate director of federal government relations and health policy for NPF. “We commend our bipartisan champions in both chambers who have worked with the patient community to ensure S.464 and H.R. 2163 keep the doctor-patient relationship at the center of care.”

The Safe Step Act was first introduced in the U.S. House in 2017 with the Senate introducing a companion bill in 2019. At the end of the 116th Congress in 2020, the legislation was supported by 175 bipartisan U.S. Senators and Representatives.  

NPF has helped to pass patient-friendly step therapy protections in over half the states in the U.S. NPF assists in leading an informal federal step therapy working group of more than 80 patient and provider organizations which played a critical role in reintroducing this important legislation.

On behalf of the more than 8 million Americans living with psoriasis and psoriatic arthritis, NPF continues to work to ensure that patients have access to affordable and effective treatments, reduce barriers to accessing adequate health care, and improve the lives of those living with psoriatic disease. To learn more about how NPF works to reform step therapy visit steptherapy.com. To learn about all of NPF advocacy efforts, visit psoriasis.org/advocacy.

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