Baby steps: Baker signs controversial step therapy law after years of negotiations

The compromise legislation streamlines the process for patients to apply for step therapy exemptions—but stops short of banning the practice outright.

Michael Weiskopf

Jody Quinn, an office manager from Plymouth, suffers from psoriatic disease—both psoriasis and psoriatic arthritis. As with many patients, her case began mildly, but as the chronic disease spread throughout her body, she experienced unbearable pain in her joints. Quinn’s doctors recommended that she start using biologics, a powerful and relatively new class of drugs designed to slow or entirely stop the inflammation of joints and organs.

According to the National Psoriasis Foundation (NPF), biologics tend to be prescribed to patients who have not responded to other treatments, such as Quinn. So when Quinn’s insurer refused to cover the biologics, she was puzzled.

“[The insurance company] wanted me to use a different, less expensive drug that I had already failed on,” Quinn said in an interview. “Instead they decided on their own to phone in another prescription that was not even prescribed to me by my own doctor.”

It took six months for the insurance company to review and deny prior authorization for the biologics. Quinn’s physician then submitted a request for a different medication, which was ultimately approved, but only after another six months.

“For one year I had no viable treatment,” Quinn said. “As a result of joint damage, I had to cut my hours back at work. This was in 2017–18, and I still have not returned full time because you don’t get that joint usage back again.”

Quinn, who began volunteering as an advocate for the NPF shortly after her insurance ordeal, is among the growing number of patients who are calling for limits on the use of step therapy, a common practice used by both private and public insurers to prevent excessive health care spending. Under step therapy policies, health plans will not cover certain procedures or prescriptions unless cheaper options have been tried first. Insurance companies say that step therapy is a necessary cost-cutting measure, but patient advocates, physicians, and even pharmaceutical companies argue that it restricts patients’ access to better care.

New law brings new hope in Massachusetts

Currently in Massachusetts, patients and their physicians can apply for step therapy exemptions if they think the cheaper treatment would be ineffective, but the review process can take weeks, or as in Quinn’s case, months. Many patients can’t afford to wait that long, according to the National Organization for Rare Disorders (NORD).

“The time it takes for a patient or their provider to file appeals or medical exceptions requests and then await an insurer’s decision, can delay necessary treatment and lead to adverse reactions that ultimately increase health care costs, not lower them,” NORD wrote in a statement.

After years of protracted negotiations in the State House, Governor Charlie Baker signed into law a scaled-back reform of step therapy in Massachusetts on Nov. 1. The legislation will require insurance companies to approve or deny step therapy exemptions within three business days, or within 24 hours in emergencies, providing patients with a timely response and alleviating what physicians see as a logistical nightmare.

The bill passed both chambers of the State House unanimously in October, but insurance companies still have concerns: they worry that the new law will make it harder to control the already-spiraling costs of pharmaceuticals.

The cost of care

The controversy over step therapy is a symptom of the broader debate between care and cost, says Amy Lischko, professor of the practice in Community Health at Tufts University. Lischko also served as commissioner of the Division of Health Care Finance and Policy and director of health policy under former Governor Mitt Romney.

“Beginning with medications that are lower cost makes a lot of sense to me from a healthcare cost perspective,” Lischko said in an interview. “[But] I know that physicians get really bothered by insurers getting in the middle of what they believe is the best care for their patients.”

State governments, as well as the federal government, have spent decades trying to deliver care that is both high-quality and inexpensive—both for the consumer and for the healthcare system—but have faced challenges when care and cost come into conflict.

The question over step therapy asks whether care or cost should be prioritized. The new law in Massachusetts tries to split the difference by allowing insurance companies to continue to use step therapy to limit costs, while also making it easier for patients to jump ahead to the more expensive treatments if necessary.

While Lischko generally agrees with the practice of step therapy, she also believes that the changes made by the new law are long overdue.

“If the patients already tried the less expensive medications and they've not been effective, I think having this paper chase and this long processing time doesn't make a lot of sense,” Lischko said. “So many things are still back in the Dark Ages when it comes to medicine… To me, this makes sense. It doesn't really eliminate the ability to use step therapy; it's just making the process more efficient.”

Insurers still have concerns

While insurance companies are generally satisfied that the state did not further restrict step therapy, many still worry that the new law will weaken their abilities to control the cost of health care. Lora Pellegrini, president and CEO of the Massachusetts Association of Health Plans, explained how a total prohibition on step therapy could have affected insurers.

“We appreciate that the Legislature has not banned step therapy, as proposed by the pharmaceutical industry, which would take away critical tools that health plans need to ensure patient safety and control costs and do little to address underlying prescription drug cost growth,” Pellegrini wrote in a statement.

Pellegrini agrees that patients should not be forced to use cheaper treatments that they know would be dangerous but argued that the new law will curtail insurers’ power to control prescription drug costs.

“MAHP and our member plans agree that health plan members should not be required to repeat a medication that is unsafe or ineffective if they change health plans and has supported proposals to ensure continuity of care,” Pellegrini wrote. “However, [the new law] goes beyond that and impacts the health plans’ ability to lower prescription drug costs and ensure patient safety. When prescription drug costs continue to be a significant health care cost driver, now is not the time to limit health plans’ ability to lower costs and keep members safe.”

Lischko explained that while she generally supports step therapy as a cost-saving measure, she does not believe the new law will increase costs.

“I don't see that it's going to necessarily increase costs that much because I feel like it's just streamlining [step therapy] a little bit,” Lischko said. “So maybe a patient had to wait two weeks before and now it's two days, so they get quicker access, but I don't really see how in the long term that's going to increase costs.”

Patient advocates applaud law, say more work needs to be done

Most patient advocacy groups agree that step therapy can be an effective cost-cutting measure when used appropriately; they are mostly concerned with making the process more efficient and less bureaucratic. Will Hubbert, grassroots and advocacy manager for the NPF, explained that his organization’s advocacy focuses on the inappropriate use of step therapy.

“We acknowledge that there's times where insurers have a legitimate interest in [having] patients try certain drugs before others,” Hubbert said in an interview. “We just want to make sure that they can't do it in cases where it's straightforwardly inappropriate, like maybe a patient has already tried and failed the medication before, or maybe their doctor knows they'll have some negative reaction to it. These are cases where it's clearly inappropriate for step therapy protocols to be applied, and yet they still are being used.”

Similarly, NORD also sees the value in using step therapy sparingly, but agrees with the NPF that the protocol is often abused.

“NORD supports policies that bolster protections for patients, while enabling health plans to achieve the cost-saving benefits of step therapy, when appropriate,” NORD wrote. “However, we find that too often it is applied to rare disease patients with little to no regard for their complex medical situation or treatment history.”

Both the NPF and NORD are optimistic that the new law in Massachusetts will make the step therapy process more efficient for patients, while also arguing that the legislation is only one of a plethora of necessary reforms. NORD also sees the new law as an effective balance between considerations of cost and care.

“NORD is confident this legislation will significantly reduce the barriers that rare disease patients in the state commonly face when trying to access their medications,” NORD said. “The new law balances protecting patients when a step therapy protocol would produce adverse health outcomes, with allowing for the use of step therapy when it is appropriate for controlling costs.”

 Meanwhile, Hubbert explained why the NPF supports the law and what other policies the organization is pushing for.

“I think [the law] is very good. It sets out a lot of good bases for appealing a step therapy protocol and requesting exemption. It has good timetables to get back to the patient after the exemption appeal has been made,” Hubbert said. “We're also aware that there are other access to care issues and other utilization management problems, such as copay accumulators, that still do need to be addressed in the state, but I think this law is a very positive step.”

From Beacon Hill to Capitol Hill

As an advocate for the NPF, Quinn has been advocating for step therapy legislation at both the Massachusetts State House and at the US Capitol since 2017. She explained that building connections with legislators—both in Boston and in Washington—has been instrumental to the progress advocates have made on the issue.

“I think familiarity was huge,” Quinn said. “When we’d first go to the State House and speak, no one knew what step therapy was. They didn’t know anybody who’d suffered from it. You’d go and tell your story, and some people would listen to you, and some people wouldn’t.”

Quinn mentioned that she met with her own state representative in March 2020, about two weeks before COVID-19 forced her to move her advocacy online. She recalled that the representative had a “glazed-over look on her eyes” and had never heard of step therapy.

“She just couldn’t identify with it,” Quinn explained. “Fast forward to two years later, she’s heard so much about step therapy… So I think the more patients that spoke up about it, that had a huge impact because the legislators saw that this is real, that it’s really hurting citizens, and that they need to do something about it.”

Meanwhile, Hubbert has found that two specific talking points have been most helpful in convincing legislators to take action on step therapy: the claim that step therapy protocols are often designed to prioritize cost at the expense of care, as well as the potential for long-term harm to patients, such as Quinn.

“You can convince lawmakers of those two facts. These aren't doctors coming up with this list so much as salespeople and industry-minded people on the insurance side, and also going off of medication even temporarily can have permanent consequences,” Hubbert said. “Both of those points are things you need to walk lawmakers through. They're not immediately obvious to them.”

While the law will protect the majority of Bay Staters from step therapy abuses, it does not apply to companies which self-insure their employees, a problem Quinn believes can only be solved by federal legislation.

“I’m happy as far as what [the law] generally does, but it’s not covering all employees…” Quinn said. “All of those [self-insured] employees would still be subjected, so it needs to encompass more, and that’s why we fight for the federal [legislation].”

While Quinn still has not fully recovered from her year without treatment, she said that the biologics she’s been taking since then have been extraordinarily effective. While she is satisfied with the new law in Massachusetts, she hopes to continue pushing for other reforms in the state, as well as at the federal level.

“These biologics and these medicines that we’re taking are extremely expensive, so that has to be addressed,” Quinn explained. “Copay accumulators, prior authorization… There's also a lot of burden on the medical community to handle all these extra things. So there’s a lot more to do.”