The Danger of Step Therapy Insurance Protocols

Alliance of Specialty Medicine
4 min readApr 7, 2021

Aline Charabaty, MD, AGAF, FACG

I practice medicine at Johns Hopkins-Sibley Hospital in the Palisades neighborhood of Washington, D.C. I am fortunate to be fewer than 10 miles from Capitol Hill, so I have met in the past with my lawmakers in support of legislation I am certain will improve patients’ health and could even save lives.

The Safe Step Act (H.R. 2163 and S. 464), is bipartisan legislation introduced by Reps. Raul Ruiz (D-CA) and Brad Wenstrup (R-OH), and Sens. Lisa Murkowski (R-AK) and Maggie Hassan (D-NH), that would provide patients and providers with a clear and transparent appeals process when subjected to step therapy protocols.

What are these protocols? It’s when an insurer requires patients to try and fail one or more therapies before the insurer covers a therapy originally prescribed by the patient’s physician. I’ve seen the negative impact step therapy has on patients’ health in my DC clinic and I’ve seen it increase health care costs.

One of my patients, I’ll call him Mr. Jones, is a perfect example of how dangerous step therapy can be. He is 60 years old and has chronic inflammatory bowel disease (IBD). The first medication he tried didn’t control his IBD. It also caused a severe allergic reaction called anaphylaxis, which required hospitalization.

After that episode, Mr. Jones was understandably reluctant to pursue further treatment, but his IBD was flaring, causing bloody diarrhea, severe abdominal pain, intolerance to eating and weight loss. He had several trips to the emergency room, missed many days at work and was considering applying for long-term disability.

We discussed the need to treat his chronic condition and I recommended a different class of drug for his IBD. He trusted my judgement that a new class of drug would be safe and effective. But his insurance company denied coverage of the drug I recommended. They required that he first try a drug in the same class as the one that caused the anaphylactic reaction!

So, we appealed to the insurance company to reconsider. I was sure the drug they wanted us to try would cause another life-threatening reaction. Weeks went by and Mr. Jones’ IBD continued to flare. Letters flew between my office and the insurance company and I had a frustrating call with an insurance company physician who was unfamiliar with gastroenterology.

Unfortunately, we lost the appeal, and I was right — Mr. Jones had another anaphylactic reaction. He was supposed to take that medication at home, but I asked him to take it in my clinic because of my concerns. That allowed us to successfully manage his reaction.

He could have died if he were at home.

In the end, the insurance company agreed to cover the drug I initially recommended. But not until after Mr. Jones endured several weeks of persistent symptoms because of ineffective therapy and another life-threatening event — that was costly to the health system.

Mr. Jones is doing well, but I’m furious.

Gastroenterologists and other specialists are trained to choose treatments based on the individual needs and unique clinical situations of our patients. Step therapy is bad for our patients and undermines a physician’s clinical expertise. So, I support the Safe Step Act, which would establish a process for physicians to appeal a step therapy protocol. It would also outline exceptions for important clinical scenarios — like Mr. Jones’ — and expedite the appeals process. Medical societies like the American Gastroenterological Association and the Alliance of Specialty Medicine have sent letters to Congress endorsing this legislation and are working with their allies on Capitol Hill to get the Safe Step Act passed into law,

The very concept of “fail first” means a patient must suffer before they can receive the therapy that their physician recommended and they need. Step therapy policies insert an insurer or CMS between the physician and patient and is disruptive and destructive to the fundamental tenet of medicine; the practice of medicine is based on valid clinical research data and the physician’s deep understanding of the characteristics of his/her patient’s disease. It is now crucial to bring the focus back to the doctor-patient relationship when determining the safest and most effective therapy for every patient.

Aline Charabaty, MD, AGAF, FACG

Dr. Charabaty is an American Gastroenterological Association advocate, Clinical Director of the Gastroenterology Division and Director of the IBD Center at Johns Hopkins-Sibley Memorial Hospital and Associate Professor of Medicine at Johns Hopkins School of Medicine.

Twitter: @DCharabaty



Alliance of Specialty Medicine

The Alliance of Specialty Medicine (the Alliance) is a coalition of national medical societies representing specialty physicians in the United States.