WASHINGTON– U.S. Senators Bill Cassidy, M.D. (R-LA), Lisa Murkowski (R-AK), and Doug Jones (D-AL) today introduced the Safe Step Act of 2019. This legislation 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. Additional cosponsors of the legislation include, Senators Maggie Hassan (D-NH), Senator Cindy Hyde-Smith (R-MS), Senator Jacky Rosen (D-NV), Senator Kevin Cramer (R-ND), and Senator Angus King (I-ME).
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.” While step therapy can be an important tool to contain the costs of prescription drugs, in some circumstances, step therapy protocols 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.
“Doctors and patients should not have to work through multiple medicines which have already failed or which may cause more harm than good,” said Dr. Cassidy. “This bill allows the proven right medicine to be given as soon as possible.”
“Lowering the cost of health care has long-been on my list of priorities, and part of that is creating a system that works for patients. As we work to reform our healthcare system, we must ensure not only affordable, but also quality care,” said Senator Murkowski. “I’ve heard story after story of individuals that have been negatively impacted by the current step therapy protocols, facing delays in care and, at times, irreversible damage due to a lapse in proper treatment. It isn’t fair to put the health of patients at risk because of rigid, unworkable standards. This bipartisan legislation helps address the currently flawed system we have in place and puts the safety and well-being of patients first.”
“This bipartisan bill will help patients get the right treatments they need at the right time,” said Senator Jones. “This is a commonsense proposal that will help patients avoid unnecessary delays in their care.”
“Introduction of the Safe Step Act means patients are one step closer to no longer being forced to try and fail on treatments that are not effective in managing their disease,” said Randy Beranek, President and CEO of the National Psoriasis Foundation. “The Safe Step Act is built on scientific and common sense guidelines that will enable millions of people to receive the appropriate treatments that health care providers know will best manage their disease. Unnecessary delays in effective treatments will no longer be required.”
“Sometimes step therapy protocols require patients to fail first on drugs that won’t work or will even cause adverse events,” said Michael Osso, President & CEO of the Crohn’s & Colitis Foundation. “This can be devastating, causing worsened health outcomes and a decreased quality of life. The Safe Step Act would create a more transparent and expeditious appeals process to ensure that patients are able to access the treatment they need, when they need it. We encourage the Senate to take swift action in passing this critical legislation.”
· 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 of fulfilling Activities of Daily Living
5. Patient is stable on their current medication