Step Therapy: Inside the Fight Against ‘Fail First’ Medicine

Every day Melissa Fulton, RN, MSN, FNP, APRN-C, shows up to work, she’s ready for another fight. An advanced practice nurse who specializes in multiple sclerosis care, Fulton says she typically spends more than a third of her time battling it out with insurance companies over drugs she knows her patients need but that insurers don’t want to cover. Instead, they want the patient to first receive less expensive and often less efficacious drugs, even if that goes against recommendations and, in some cases, against the patient’s medical history.

The maddening protocol — familiar to healthcare providers everywhere — is known as “step therapy.” It forces patients to try alternative medications ― medications that often fail ― before receiving the one initially prescribed. The process can take weeks or months, which is time that some patients don’t have. Step therapy was sold as a way to lower costs. However, beyond the ethically problematic notion of forcing sick patients to receiver cheaper alternatives that are ineffective, research has also shown it may actually be more costly in the long run.

Fulton, who works at Saunders Medical Center in Wahoo, Nebraska, is a veteran in the war against step therapy. She is used to pushing her appeals up the insurance company chain of command, past nonmedical reviewers, until her patient’s case finally lands on the desk of someone with a neurology background. She says that can take three or four appeals — a judge might even get involved — and the patient could still lose. “This happens constantly,” she says, “but we fight like hell.”

Fortunately, life may soon get a little easier for Fulton. In late March, a bill to restrict step therapy made it through the Nebraska state legislature and is on its way to the governor’s desk. The Step Therapy Reform Act doesn’t outright ban the practice; however, it will put guardrails in place. It requires that insurers respond to appeals within certain time frames, and it creates key exemptions.

When the governor signs off, Nebraska will join more than two dozen other states that already have step therapy restrictions on the books, according to Hannah Lynch, MPS, associate director of federal government relations and health policy at the National Psoriasis Foundation, a leading advocate to reform and protect against the insurance practice. “There’s a lot of frustration out there,” Lynch says. “It really hinders providers’ ability to make decisions they think will have the best outcomes.”

Driven by coalitions of doctors, nurses, and patients, laws reining in step therapy have been adopted at a relatively quick clip, mostly within the past 5 years. Recent additions include South Dakota and North Carolina, which adopted step therapy laws in 2020, and Arkansas, which passed a law earlier this year.

Lynch attributes growing support to rising out-of-pocket drug costs and the introduction of biologic drugs, which are often more effective but also more expensive. Like Nebraska’s law, most step therapy reform legislation carves out exemptions and requires timely appeals processes; however, many of the laws still have significant gaps, such as not including certain types of insurance plans.

Ideally, Lynch said, the protections would apply to all types of health plans that are regulated at the state level, such as Medicaid, state employee health plans, and coverage sold through state insurance exchanges. Closing loopholes in the laws is a top priority for advocates, she added. She pointed to work currently underway in Arkansas to extend its new protections to Medicaid expansion patients.

“With so many outside stakeholders, you have to compromise — it’s a give and take,” Lynch says. Still, when it comes to fighting step therapy, she says, “Any protection on the books is always our first goal when we go into a state.”

Putting Patients First

Lisa Arkin, MD, a pediatric dermatologist at the University of Wisconsin–Madison, said she finds herself “swimming upstream every day in the fight with insurance.” Her patients are typically on their second or third stop and have more complex disorders. Arkin says the problem with step therapy is that it tries to squeeze all patients into the same box, even if the circumstances don’t fit.

Her state passed restrictions on step therapy in 2019, but the measures only went into effect last year. Under the Wisconsin law, patients can be granted an exemption if an alternative treatment is contraindicated, likely to cause harm, or expected to be ineffective. Patients can also be exempt if their current treatment is working.

Arkin, an outspoken advocate for curbing step therapy, says the Wisconsin law is “very strong.” However, because it only applies to certain health plans — state employee health plans and those purchased in the state’s health insurance exchange — fewer than half the state’s patients benefit from its protections. She notes that some of the most severe presentations she treats occur in patients who rely on Medicaid coverage and already face barriers to care.

“I’m a doctor who puts up a fuss [with insurers], but that’s not fair — we shouldn’t have to do that,” Arkin says. “To me, it’s really critical to make this an even playing field so this law affords protection to everyone I see in the clinic.”

Major medical associations caution against step therapy as well. The American Society of Clinical Oncology and the American Medical Association have called out the risks to patient safety and health. In fact, in 2019, after the Centers for Medicare & Medicaid Services gave new authority to Medicare Advantage plans to start using step therapy, dozens of national medical groups called out the agency for allowing a practice that could potentially hurt patients and undercut the physician-patient decision-making process.

Last year, in a new position paper from the American College of Physicians (ACP), authors laid out recommendations for combating step therapy’s side effects. These recommendations included making related data transparent to the public and minimizing the policy’s disruptions to care. Jacqueline C. Fincher, MD, MACP, a member of the committee that issued the position paper and who is a primary care physician in Georgia, said such insurance practices need to be designed with “strong input from frontline physicians, not clipboard physicians.

“What we want from insurers is understanding, transparency, and the least burdensome protocol to provide patients the care they need at a cost-effective price they can afford,” says Fincher, who is also the current president of the ACP. “The focus needs to be on what’s in the patient’s best interest.”

Every Year a New Fight

“We all dread January,” says Fincher. She says that is the worst month because new health benefits go into effect, which means patients who are responding well to certain treatments may suddenly face new restrictions.

Another aggravating aspect of step therapy? It is often difficult — if not impossible — to access information on specific step therapy protocols in a patient’s health plan in real time in the exam room, where treatment conversations actually take place. In a more patient-centered world, Fincher says, she would be able to use the electronic health record system to quickly identify whether a patient’s plan covers a particular treatment and, if not, what the alternatives are.

Georgia’s new step therapy law went into effect last year. Like laws in other states, it spells out step therapy exemptions and sets time frames in which insurers must respond to exceptions and appeals. Fincher, who spoke in favor of the new law, says she’s “happy for any step forward.” Still, she said, the growing burden of prior authorization rules are an utter “time sink” for her and her staff.

“I have to justify my decisions to non-doctors before I even get to a doctor, and that’s really frustrating,” she says. “We’re talking about people here, not widgets.”

Advocates in Nevada are hoping this is the year a step therapy bill will make it into law in their state. As of March, one had yet to be introduced in the state legislature. Tom McCoy, director of state government affairs at the Nevada Chronic Care Collaborative, said existing Nevada law already prohibits nonmedical drug switching during a policy year; however, insurers can still make changes the following year.

A bill to rein in step therapy was proposed previously, McCoy said, but it never got off the ground. The collaborative, as well as about two dozen organizations representing Nevada providers and patients, are now calling on state lawmakers to make the issue a priority in the current session.

“The health plans have a lot of power — a lot,” McCoy says. “We’re hoping to get a [legislative] sponsor in 2021…but it’s also been a really hard year to connect legislators with patients and doctors, and being able to hear their stories really does make a difference.”

In Nebraska, Marcus Snow, MD, a rheumatologist at Nebraska Medicine, in Omaha, says the state’s new step therapy law will be a “great first step in helping to provide some guardrails” around the practice. He notes that turnaround requirements for insurer responses are “sorely needed.” However, he says that because the bill doesn’t apply to all health plans, many Nebraskans still won’t benefit.

Dealing with step therapy is a daily “headache” for Snow, who says navigating the bureaucracy of prior authorization seems to be getting worse every year. Like his peers around the country, he spends an inordinate amount of time pushing appeals up the insurance company ranks to get access to treatments he believes will be most effective. But Snow says that, more than just being a mountain of tiresome red tape, these practices also intrude on the patient-provider relationship, casting an unsettling sense of uncertainty that the ultimate decision about the best course of action isn’t up to the doctor and patient at all.

“In the end, the insurance company is the judge and jury of my prescription,” Snow says. “They’d argue I can still prescribe it, but if it costs $70,000 a year — I don’t know who can afford that.”

Lynch, at the National Psoriasis Foundation, said their step therapy advocacy will continue to take a two-pronged approach. They will push for new and expanded protections at both state and federal levels. Protections are needed at both levels to make sure that all health plans regulated by all entities are covered. In the US Senate and the House, step therapy bills were reintroduced this year. They would apply to health plans subject to the federal Employee Retirement Income Security Act, which governs employer-sponsored health coverage, and could close a big gap in existing protections. Oregon, New Jersey, and Arizona are at the top of the foundation’s advocacy list this year, according to Lynch.

“Folks are really starting to pay more attention to this issue,” she says. “And hearing those real-world stories and frustrations is definitely one of the most effective tools we have.”

Kim Krisberg is a freelance journalist based in Austin, Texas, who reports on public health, science, and health policy. She’s a regular contributor to Austin Monthly magazine and The Nation’s Health newspaper.

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