Congress reintroduces Safe Step Act to amend step therapy policies
Key takeaways:
- Step therapy, a controversial payer policy, can cause treatment delays and contribute to physician burnout.
- Advocacy groups support legislation like the Safe Step Act to change this practice.
Physicians and patient advocacy groups are rallying behind a renewed legislative effort in Congress to amend what they claim are harmful step therapy practices that often delay or deny effective treatments to people with chronic conditions.
In September, members of the U.S. House and Senate reintroduced the Safe Step Act, which will require group health insurance plans to offer a timely exceptions process when step therapy is not in a patient’s best interest.
Created in the 1980s by health insurance companies, step therapy is a policy that requires patients to attempt lower cost treatments before “stepping up” to the medication their doctor initially prescribed, according to an article from the American College of Rheumatology.
“Step therapy is a tool used by insurance plans to control spending by asking an individual to try and fail insurer preferred medications before their plan will allow access to the treatment that might have been originally prescribed by that person’s provider,” Jason Harris, vice president of government relations and advocacy at the National Psoriasis Foundation (NPF), told Healio. “It is also known as ‘fail-first’ therapy.”
Christina Downey, MD, CCD, RhMSUS, DipABLM, FACR, associate professor in the department of medicine and division chair of rheumatology at the Loma Linda University Medical Center and chair of the Government Affairs Committee for the American College of Rheumatology, told Healio that this policy financially benefits insurance companies, not patients.
“The preference is often described as for the ‘less expensive’ treatment but may be for the treatment whose cost was negotiated to the greatest advantage of the pharmacy benefit managers organizing the formulary of the payer, even if that treatment’s original price from the manufacturer was not lower than the prescribed treatment from the physician,” Downey said. “The option available on formulary may provide the best cost savings for the insurer, but that may not necessarily translate to the lowest out-of-pocket cost for the patient.”
In many cases, step therapy protocols are vague, confuse physicians and delay treatment for patients, according to advocates for the legislative reform. If passed, the Safe Step Act would not eliminate step therapy but would require insurance companies to implement clearer guidelines for physicians to apply for step therapy exemptions.
Recommended reforms
According to a press release from the NPF, the Safe Step Act would require insurance companies to grant exemptions for the following reasons:
- The patient already tried the required treatment and was nonresponsive.
- The step therapy protocol’s treatments are expected to be ineffective.
- The treatments required by step therapy could cause an adverse event.
- The treatments will inhibit a patient from going to work or performing daily activities.
- The patient is stable on their current treatment that was covered by their previous payer.
Once a provider submits a step therapy exemption request, payers would be obligated to respond within 24 hours for emergencies and 72 hours for nonemergencies, the NPF reports.
As part of Eczema Awareness Month in October, the National Eczema Association (NEA) is holding its first Eczema Policy Summit in Washington, DC. On Oct. 21, the NEA released updated data to “reinforce an established need for legislative and regulatory solutions,” including step therapy reform.
“The Safe Step Act introduces a clear and fair process with timelines for insurer’s response,” Kristin Belleson, MBA, CAE, president and CEO of NEA, told Healio. “For people with eczema, this could mean a difference between a week of discomfort and months of uncontrolled disease.”
‘Disastrous’ delays for patients
In 2024, the National Health Council reported approximately 160 million people living with chronic disease in the U.S. According to Harris, more than 50% of them have likely faced step therapy.
“We had an advocacy day 2 years ago and asked a room of 60 to 70 people to raise their hand if they had ever experienced step therapy,” Harris said. “Everyone’s hand in the room was up.”
A 2016 Arthritis Foundation survey also found that most patients experienced negative health effects from delays in getting the right treatment. More than 50% of survey respondents reported having to try two or more different drugs before receiving the one their doctor originally prescribed.
“Step therapy was stopped in 39% of cases because the ‘preferred’ drugs were ineffective and 20% of the time due to worsening conditions,” Downey told Healio concerning the report. “Nearly 25% of patients who switched insurance providers were required to repeat step therapy with their new carrier.”
Repeating previously failed therapies after a change in payers is a common occurrence, according to Bruce Brod, MD, MHCI, FAAD, clinical professor of dermatology, director of the Occupational and Contact Dermatitis Clinic and associate dean of continuing medical education and interprofessional collaboration at the University of Pennsylvania Perelman School of Medicine.
“After going through step therapy — trying conventional treatment options, topical medications and even a form of UV therapy — I had a patient with debilitating atopic dermatitis from head to toe that was finally able to go on a biologic drug and did very well,” Brod told Healio. “But then, their employer switched to another insurance company that did not cover the patient’s prescription anymore.”
The insurance provider placed the patient on a step therapy protocol, citing the patient’s mild condition as one of the reasons for doing so. However, the patient’s condition was considered mild because the medication had improved its severity, Brod said. To receive an approval for the medication once more, the patient was required to stop the medication and flare up again — a process that took months, according to Brod.
“This is somebody who was in the workforce,” Brod said. “They couldn’t sleep, they couldn’t function, and their skin was bleeding all the time.”
In addition to dermatologists, rheumatologists are also acutely aware of the consequences of step therapy. The management of rheumatologic conditions often involves using expensive biologic drugs, Downey said.
“Medications rheumatologists use often require a 12-week trial before we can try a different medication, even if the medication isn’t effective,” Downey said. “This means if a patient can’t get the drug his or her rheumatologist recommends based on experience and individual patient factors the first time, then it may be a year before that patient goes through the steps required to get access to the drug the physician wanted from the beginning.”
In these situations, the only treatment option patients have left is prednisone — a steroid that comes with higher risks for increased blood sugar, blood pressure, weight gain and more.
Moreover, insurance providers do not have to allow for continuation of therapy when formularies change, even if patients are stable on the therapy, Downey said.
“We know that between January and March our office is going to be inundated with frantic calls from patients who have been told by their insurance carriers that they can no longer take the medication they are prescribed and instead have to change to a different medication,” Downey told Healio. “In rheumatology, this can be disastrous because the immune system can stop responding to a therapy if it is stopped for too long or if a different drug has been used in the interim.”
Procedural hurdles ‘sucking up all the oxygen in the room’
Out of 1,000 practicing physicians surveyed by the AMA in 2024, 95% reported prior authorization — which includes step therapy — somewhat or significantly increases physician burnout. According to the AMA’s report, each practice completes 43 prior authorizations per physician, amounting to 12 hours of additional work for them and their staff, per week.
“Any given day, I will have four or five messages that I must respond to for prior authorizations and step therapy,” Brod told Healio. “It is sucking up all the oxygen in the room. In my practice, we had to hire a dedicated person just to deal with all the paperwork.”
Brod’s experience is not uncommon. The AMA’s report found many physicians hire additional office staff specifically to handle prior authorizations and step therapy appeals — a cost of around $75,000 a year that could have been redirected to patient care, Downey said.
Employees hired for this position typically do not stay for long, Brod said.
“It is a horrible job,” Brod said. “The turnover in our office for the person who has to deal with all the step therapy and prior authorizations is very high because it is boring, rote and frustrating work.”
Step therapy protocols lack transparency and insurance providers do not clearly communicate the steps patients must take before a physician prescribes a medication, according to Downey.
“I’ve had more visits than I can count when I’ve discussed the options for treatment with a patient and, together, we’ve selected the option that best fits their unique needs, only to have the medication be denied with requirements to try other medications first,” Downey said. “At the visit, we didn’t discuss the risks and benefits of the required medications, so the patient either has to come back to the office and pay another copay to discuss this other medication, or the physician has to call the patient after hours, without any compensation, to discuss the required option over the phone.”
If a peer-to-peer review is required after a prescription denial due to step therapy, the AMA’s report found that just 15% of physicians often or always speak to a peer with the appropriate qualifications.
“I ended up having to do a peer-to-peer with somebody at the insurance company who wasn’t even a dermatologist,” Brod said. “I had to walk them through Dermatology 101 to get the medications approved for my patient. All of this takes so much time.”
Pushback on passage
Legislation to reform step therapy was first introduced during the 115th Congress in the House in 2017, according to the NPF. By 2020, at the end of the 116th Congress, the legislation was supported by 175 U.S. Senators and Representatives across party lines. Despite bipartisan support, the legislation has yet to pass.
“When you think of how the federal government and Congress has worked the last 15 years, especially recently, things have been slower in terms of what gets passed,” Harris told Healio. “It takes time to build consensus and educate others on the need for something like this.”
During the 118th Congress, the Safe Step Act had the most support to date, with more than half the House and nearly 40% of the Senate cosponsoring the bill. This allowed the Safe Step Act to be placed into the Senate Health Committee’s package related to pharmacy benefit manager reform, the final step before the act would have been included in a larger package for a floor vote.
“Our hope for this Congress is that the House Education and Workforce Committee brings the bill forward for a committee markup. That would be a tremendous signal for the prospects of this legislation,” Harris said. “Last year, during the lame duck session in Congress, the chances of a larger health and pharmacy benefit managers reform package, possibly including the Safe Step Act, stumbled, which was disappointing.”
According to Harris, some pushback related to the bill comes down to spending. The 2024 Congressional Budget Office estimated that the Safe Step Act would reduce federal revenue by $2 billion over a decade — a figure the NPF has challenged.
“We completely disagree with the assumptions made that allowed them to arrive at that number,” Harris said. “There are a lot of costs that are not quantified, such as delays in care, which lead to emergency room visits and increasing burdens on physician offices.”
Nevertheless, the NPF remains hopeful for the future of the Safe Step Act.
“This issue is making progress; it is just moving much slower than we would like,” Harris said. “Although the bill has not passed yet, it made the most progress during the last Congress, which is exciting as we move forward with its reintroduction.”
Champion patient voices
In the U.S., 37 states have enacted protections against step therapy, according to the Safe Step Act website. However, these protections apply only to state insurance plans and not commercial insurance, leaving millions of Americans vulnerable to delayed treatment and limited access to necessary medication.
Passing the Safe Step Act would be important for patients and health care professionals, according to Downey.
“If a physician could do a quick search for the patient’s insurance step therapy rules, they could discuss the right option with the patient at the time of the visit and not require additional wasted time and work after the visit that delays the patient getting the medication they need,” Downey said. “Currently, Medicare Advantage plans allow up to 7 days to complete prior authorization requests. Other plans may allow up to 15 days to answer a prior authorization request. This pushes back treatment by 1 week. When patients with systemic inflammatory disease aren’t treated promptly, it leads to irreversible organ damage. That can’t be undone.”
If Congress fails to pass the legislation, it would be “a disappointing, missed opportunity to better the lives of millions of Americans,” according to Leah M. Howard, JD, president and CEO of the NPF, but it would not stop advocacy organizations from continuing to pursue change on the state level.
“As a national advocacy coalition leader working to pass similar legislation in dozens of states, we have had a lot of conversations with all stakeholders, especially those on the insurer side,” Howard told Healio. “That collaboration has built a deep mutual understanding about what we are trying to do here to improve people’s access to the treatments they need.”
“Every conversation is a step toward a system that treats people and not paperwork,” Belleson also told Healio. “Eczema does not discriminate, so our advocacy shouldn’t either.”
As organizations continue to push for reform amid a climate rife with “gridlock and many competing priorities,” Belleson said, keeping patients at the forefront of these efforts is what will make a difference.
“When we are talking to lawmakers or agencies or the public, we bring in those patient voices,” Belleson told Healio. “Patient stories resonate. That is what will cut through the noise.”
For more information:
Kristin Belleson, MBA, can be reached at [email protected].
Bruce Brod, MD, MHCI, FAAD, can be reached on LinkedIn.
Christina Downey, MD, CCD, RhMSUS, DipABLM, FACR, can be reached at [email protected].
Jason Harris, can be reached at [email protected].
Leah M. Howard, JD, can be reached at [email protected].