NEWS: Ruiz, Bipartisan Doctors in Congress Introduce Safe Step Act to Require Insurance Companies to Put Patients’ Health First

March 26, 2021
Press Release

Washington, D.C. – Today, Representative Raul Ruiz, M.D. (D-CA) announced the introduction of H.R. 2163, the Safe Step Act – a bipartisan bill to improve step therapy protocols and ensure patients are able to safely and efficiently access the best treatment for them. Step therapy protocols can cause unnecessary delays in care, or worse, require patients to try ineffective or potentially dangerous medications before finding the treatment most suited to their needs.

Representatives Brad Wenstrup, D.P.M. (OH-02), Lucy McBath (GA-06), and Mariannette Miller-Meeks, M.D. (IA-02) joined Congressman Ruiz in introducing the legislation in the House. Senators Lisa Murkowski (R-AK), Maggie Hassan (D-NH), Bill Cassidy, M.D. (R-LA), and Jacky Rosen (D-NV) introduced the companion bill in the Senate.

“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 Congressman 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."

“Creating a practical, supportive healthcare system that meets patients where they are remains one of my top priorities,” said Senator Murkowski. “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.” 

“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.”

"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 Rep. 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 Rep. 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.” 

Background: Step therapy is a tool used by health plans to control spending on patient’s medications. While step therapy can be an important tool to contain the costs of prescription drugs, in some circumstances, it has negative impacts on patients, including delayed access to the most effective treatment, severe side effects, and irreversible disease progression.

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. This protocol is known as “step therapy” or “fail first.” Step therapy protocols may ignore a patient’s unique circumstances and medical history. That means patients may have to use medications that previously failed to address their medical issue, or – due to their unique medical conditions – could have dangerous side effects.

H.R. 2163, the Safe Step Act amends the Employee Retirement Income Security Act (ERISA) to require a group health plan provide an exception process for any medication step therapy protocol. The bill:

  • 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. A patient already tried and failed on the required drug. A patient has already tried the medicine and failed before.
  2. Delayed treatment will cause irreversible consequences. The drug is reasonably expected to be ineffective, and a delay of effective treatment would leave to severe or irreversible consequences.
  3. Required drug will cause harm to the patient. The treatment is contraindicated or has caused/is likely to cause an adverse reaction.
  4. Required drug will prevent a patient from working or fulfilling Activities of Daily Living The treatment has or will prevent a participant from fulfilling their occupational responsibilities at work or performing Activities of Daily Living. Activities of daily living (ADLs) mean basic personal everyday activities such as eating, toileting, grooming, dressing, bathing, and transferring (42 CFR § 441.505).
  5. Patient is stable on their current medication. The patient is already stable on the prescription drug selected by his or her provider, and that drug has been covered by their previous or current insurance plan.
  • 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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