A Step Forward, Perhaps, for Safe Step Act and Exemptions from Step Therapy

Legislation that aims to make it easier for patients to get exemptions from the step therapy requirements has been folded into one of the several U.S. Senate bills targeting pharmacy benefit managers (PBMs), and patient and provider organizations are optimistic about PBM legislation — in one form or another — becoming law.

“PBM reform is going to pass in this Congress — (although) I wouldn’t say by the end of this year — and it will include step therapy reform,” Erin McKeon, associate director, federal advocacy, for the Crohn’s & Colitis Foundation.

The current Congress, the 118th, is scheduled to adjourn at the very beginning of January 2025.

The Safe Step Act, which was first introduced in House in 2017 and the Senate two years later, has had broad bipartisan support but has languished. Last month, it was included as an amendment to the Pharmacy Benefit Reform Act approved by the Senate’s Health, Education, Labor, and Pensions (HELP) committee.

Sen. Lisa Murkowski, an Alaska Republican, agreed to have the Safe Step Act incorporated into the Pharmacy Benefit Reform Act.

Sen. Lisa Murkowski, an Alaska Republican, was the sponsor of the Safe Step Act and agreed to maneuver to make it an amendment to the HELP committee’s PBM legislation rather than stay a standalone piece of legislation.

The Senate Finance Committee and by Senate Committee on Commerce, Science, and Transportation Committee are also considering PBM bills.

McKeon said in an interview with Managed Healthcare Executive that eventually the PBM bills (or parts of them) will be assembled into a single bill. Senate Majority Leader Charles Schumer has agreed to give the combined bill “time on the floor” and consideration by the full Senate, but the timing is uncertain, McKeon said.

A similar legislative process is occurring in the House, she said. “It’s sausage making,” McKeon quipped.

The three Senate bills have bipartisan support, and the PBM industry has been criticized — sometimes in stark, harsh terms — by members on both sides of the aisle.

McKeon said that part of the current political dynamic is that the different committees, and their chairs and ranking members, are vying for credit curbing PBMs.: “Both Democrats and Republicans are saying, ‘we want this, we want this.’ Which is a good place to be. I will give credit to whomever. Can we just get this done.”

Step therapy involves PBM and insurer company requirements that patients try certain, often less expensive, therapy first before “stepping up” to a different, often more expensive medication. The insurers and the PBMs say step therapy is a way to curb drug costs and prescribing patterns influenced by pharmaceutical marketing and that many people’s health conditions are successfully treated with less expensive drugs.

But step therapy is anathema to many patients, patient advocacy groups, providers and their professional organizations. They say that step therapy can jeopardize people’s health because they must take and “fail” less effective medications before PBMs and the insurers agree to cover more effective medication.

Step therapy requirements affect patients with Crohn’s disease and ulcerative colitis because anti-inflammatory (5-aminosalicylates and corticosteroid) and immunosuppressant medications are viewed as front-line treatments that many patients should be treated with before they are prescribed expensive biologics, such as Humira (adalimumab) or Stelara (ustekinumab).

McKeon said the Safe Step Act lists five circumstances when patients and providers are automatically allowed to file for exemptions from step therapy and that the health plan or its PBM is required to respond within 72 hours (24 hours if it is emergency). As with the rest of the HELP committee bill, the provisions would apply to health plans funded by employers, which are largely exempt from state insurance laws because of the Employee Retirement Income Security Act. The timing provision is important, McKeon said, because health plans sometimes take months to respond to requests for exemptions to step therapy and there are instances of patients getting sicker while they wait to get the prescribed medication approved for coverage.

The five exceptions are cases when the patient has already tried a drug required by the step therapy and “failed” on it; when the patient’s provider says delays in access to the prescribed treatment would result in severe or irreversible consequences; when the patient’s provider says the drug required by the step therapy protocol would cause harm; when side effects (such as drowsiness) from the treatment required by step therapy would prevent a patient from working or going to school; and when the patient is stable on a medication.

PBMs and insurers don’t necessarily need to go along with the request for exception to their step therapy requirements, but there would be an appeal process if they did reject the request.

McKeon said that more than 30 states have enacted step therapy laws that are similar to (and in some cases, identical to) provisions in the Safe Step Act. The state laws apply to health plans subject to state law.

“We’re seeing no major disruption in those state markets,” she said. “What we’re trying to do is follow what the states have done at the federal level to reach the employer-sponsored plans.”