Sens. Marshall, Murkowski, Hassan, Rosen Reintroduce Bipartisan Bill to Provide Patients with Transparent and Safe Access to Treatments

(Washington, D.C., March 10, 2023) – U.S. Senators Roger Marshall, M.D. (R-KS), Lisa Murkowski (R-AK), Maggie Hassan (D-NH), 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.

“Throughout my career as a physician, I fought for my patients to have access to the medication that would work best for them,” said Senator Marshall. “Unfortunately, health plans often require patients to ‘fail first’ on older medications before they try what their physician originally determined to be clinically best for them. This process is painful and can cause irreversible damage to patients, especially those with severe conditions. What’s worse is when patients, who are stable on their medication, are forced go through this ‘fail first’ policy all over again if they switch jobs or health plans. Our bipartisan, bicameral legislation removes these damaging policies so patients can get on and stay on treatment that works best for them.”

“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,” said Senator Lisa Murkowski. “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.”

“Needless barriers to treatment can endanger a patient’s health and disrupt their care or health coverage,” said Senator Hassan. “The bipartisan Safe Step Act will help patients get the most effective medication more quickly.”

“Patients, especially those battling serious medical conditions, should be able to receive the treatments their physicians prescribe in a timely and efficient manner,” said Senator Rosen. “I support this bipartisan legislation to ensure patients avoid unnecessary delays in their care and receive the most effective and medically appropriate treatment. I will continue working to improve care for patients in Nevada and across the nation.”

“As an employer, the National Psoriasis Foundation (NPF) prides itself on creating a work environment that is positive, healthy, and effective. I hope this bill is a win for employers, employees, and health plan providers. Acting as a leader and collaborator, NPF will continue our relentless push to establish reasonable step therapy protections at the federal and state levels – until the job is done. Our community and all those impacted by chronic disease deserve access to the treatments they are prescribed,” said Leah M. Howard, JD, President and CEO, National Psoriasis Foundation.

“Step therapy requirements can cause unnecessary and often harmful delays in care for people with neurologic conditions. To ensure that neurologists can provide the care their patients need when they need it, these requirements need to be reformed. For this reason, the AAN is pleased to support the Safe Step Act of 2023 to create a clear exception process to step therapy protocols and to ensure those exceptions are approved in a timely manner. This legislation will clearly help neurologists care for patients,” said Orly Avitzur, MD, MBA, FAAN, President, American Academy of Neurology.

“The Crohn’s & Colitis Foundation hears each day from patients struggling to get the treatment their healthcare providers have ordered. The Safe Step Act will make great strides in insuring that IBD patients have access to the medications prescribed by their doctors,” said Laura Wingate, Executive Vice President, Education, Support & Advocacy, Crohn’s & Colitis Foundation.

“Step therapy prevents my patients with inflammatory bowel disease (IBD) from getting the timely, prescribed treatment that will manage their condition and help them to live normal, productive lives. The Safe Step Act is a much-needed step in the right direction to ensure continuity of care for my patients who have already tried and failed many of the policies that insurers insist they go through over and over. This commonsense legislation will ensure that patients get the treatments that they need in a timely manner,” said Maria Abreu, MD, Vice President, American Gastroenterological Association.

“Patients are caught between the high cost of prescription drugs and the use of step therapy protocols by insurance companies. The Safe Step Act creates clear exceptions to step therapy protocols to ensure that medical decisions made by physicians in consultation with their patients are respected, and the health and safety of patients are a priority. ACOI is pleased to offer its strong endorsement of the legislation and calls for its passage by Congress,” said Joanne Kaiser-Smith, DO, FACOI, President, American College of Osteopathic Internists.

 Bill Highlights:

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.

Notably, the bipartisan legislation outlines five exceptions to fail firstprotocols and requires that a group health plan grant an exemption if an application clearly demonstrates any of the following situations:

  • The patient already tried and failed on the required drug.
  • The delayed treatment will cause irreversible consequences and negative impact the patient’s medication. 
  • The prescription drug the health plan is requiring the patient to “fail first” on will cause harm to the patient.
  • The required drug will prevent a patient from working or fulfilling activities of daily living.
  • The patient is stable on their current medication.

In addition, the legislation would require health plans to provide a timely response to the exemption requests including 72 hours in all circumstances and 24 hours if the patient’s life is at risk.