Murkowski, Hassan, Cassidy, Rosen Reintroduce Bipartisan, Bicameral Legislation to Give Patients Safe, Timely Access to Treatment

Washington, DC— U.S. Senators Lisa Murkowski (R-AK), Maggie Hassan (D-NH), Bill Cassidy (R-LA), Jacky Rosen (D-NV) introduced the Safe Step Act of 2021, legislation to put reasonable limits on step therapy. Companion legislation was introduced in the U.S. House of Representatives by Representative Raul Ruiz (D-CA-36) Brad Wenstrup, D.P.M. (OH-02), Lucy McBath (GA-06), and Mariannette Miller-Meeks, M.D. (IA-02).

Currently, when a physician prescribes a particular drug treatment for a patient, the patient’s insurance company may require them to try different medications and treatments before they can access the drug originally prescribed by their physician, a protocol known as “step therapy” or “fail first.” While step therapy can be an important tool to contain the costs of prescription drugs, in some circumstances, it may ignore a patient’s unique circumstances and medical history. Due to their unique medical conditions, this method could have negative impacts on patients, including delayed access to the most effective treatment, severe side effects, and irreversible disease progression.

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.

For additional information on the bill, click here.

For full text of the bill, click here.

“Creating a practical, supportive healthcare system that meets patients where they are remains one of my top priorities. As we continue efforts to reform America’s healthcare system, we must ensure that care is affordable and accessible—but also high quality. I continue to hear from patients and families on the negative impacts of the current step therapy protocols. Many have experienced unnecessary delays in care and, at times, endured irreversible damage due to a lapse in proper treatment. The system we have in place doesn’t work for many patients. I’m proud to reintroduce this bipartisan legislation to remove unworkable standards, putting the well-being of patients first,” said Senator Murkowski.

“It can endanger patients’ health and well-being when they have to jump through hoops and try other medications before their insurance company will cover the medication that their doctor believes would be best for them,” said Senator Hassan. “This bipartisan legislation will help patients receive the health care that they need in a timely fashion, without interference from their insurance company. The bipartisan Safe Step Act is commonsense legislation that will help save lives, and I urge my colleagues on both sides of the aisle to support it.” 

“Patients should not have to take multiple medicines, which have already failed or may cause more harm, before receiving the one originally prescribed by their doctor,” said Dr. Cassidy. “This bill allows patients to receive the right treatment as soon as possible.”

“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 a physician, I took an oath to put patients first. The Safe Step does exactly that,” said Dr. Ruiz. “It is not safe or fair for patients to be forced to use medications that don’t work for them simply because of insurance companies’ protocols that do not take the patient’s unique health needs into account. These delays can cause unnecessary pain, suffering, and cost for patients. My bill will help patients get the medicine they need to live healthy, productive lives. I was pleased to work across the aisle and chambers to develop a patient-centered approach to step therapy protocols that puts the health of Americans over insurance companies’ bottom lines.”

"As we continue to modernize medicine, we need to address the unnecessary delays in care caused by 'fail first' policies – also known as 'step therapy.' Forcing patients to try and fail with different treatments before getting what their doctor originally prescribed puts them in a potentially dangerous situation — often with increased costs. It also places additional financial burdens on our health care system as a whole," said Representative Wenstrup. "I'm proud to lead this bipartisan effort to create commonsense step therapy protections for patients to ensure they get the best treatment that is right for them."

"With the introduction of the Safe Step Act, we reaffirm the value of the doctor-patient relationship in medicine and move closer toward the best form of patient-centered care. "Fail-safe" and step therapy can cause undue harm and slow the recovery of patients, while frustrating doctors who are simply trying to care for their patients,” said Representative McBath. “We must always fight to put people first, and this legislation will help ensure doctors and patients can make the best possible health care decisions.”

“As a doctor, I believe that our patients deserve the best treatment and care available to them as prescribed by the treating doctor. Step therapy has too often circumvented the doctor-patient relationship and forced patients to put their own health at-risk,” said Representative Miller-Meeks. “I believe that the Safe Step Act will help give patients the safest and most effective treatment options. This is a bipartisan, commonsense solution to something that has affected too many for too long.” 

Additional original cosponsors of the legislation include: U.S. Senators Cindy Hyde-Smith (R-MS), Kirsten Gillibrand (D-NY), Kyrsten Sinema (D-AZ), Shelley Moore Capito (R-WV), Mazie Hirono (D-HI), Thom Tillis (R-NC), Jeanne Shaheen (D-NH), Kevin Cramer (R-ND), Jeff Merkley (D-OR) and Richard Blumenthal (D-CT).

“My son lost six months of his life because of step therapy while battling Crohn’s disease,” Amber said. “No parent wants to see their child hurt - it was painful to watch. He couldn’t eat solid foods and he had to have two blood transfusions. Those six months were a waste of time and money all while he was wasting away. But once he received the biologic medication his doctor originally prescribed, he felt immediately better. I can only guess that had he not been subjected to step therapy, his quality of life would have improved drastically,” said Amber Downs, Anchorage, Alaska.

“This bipartisan legislation has the potential to benefit over 150 million Americans living with complex and chronic health conditions, like psoriasis and psoriatic arthritis, by implementing commonsense protections to ensure patients receive the most medically appropriate treatment in a timely manner. We commend Senators Murkowski, Cassidy, Hassan and Rosen for understanding the critical need for federal legislation to keep patients and their health care providers primary decision-makers when selecting the best treatments for managing health outcomes,” Randy Beranek, President and CEO of the National Psoriasis Foundation.

“Too many patients are unable to access the treatments they need when they need them because of step therapy protocols,” said Michael Osso, President & CEO of the Crohn’s & Colitis Foundation. “This can lead to untreated disease, hospitalizations, surgeries, and generally worsened health outcomes. The Safe Step Act will help provide a clear and transparent process so that patients can access the medication they need when they need it.”

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:

1. Patient already tried and failed on the required drug
2. Delayed treatment will cause irreversible consequences
3. Required drug will cause harm to the patient
4. Required drug will prevent a patient from working or fulfilling Activities of Daily Living
5. 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.

Background:

In September 2019, U.S. Senators Lisa Murkowski, Doug Jones (D-AL), and Bill Cassidy introduced the Safe Step Act of 2019 and highlighted personal patient stories that emphasize the importance of these protocols.

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