The American Gastroenterological Association (AGA) is concerned with patient access to affordable medicines. As insurers continue to use utilization management tools like prior authorization and step therapy that delay and restrict patients’ access to timely treatment, AGA is working with other medical specialty societies and patient advocacy groups to advocate for patient protections for such  protocols. Gastroenterologists are trained to choose treatments based on the individual needs and unique clinical situations of their patients and step therapy threatens these important clinical decisions.

Step therapy, also known as “fail first” requires patients to try and fail one or more therapies before the insurer will cover the therapy originally prescribed by the patient’s physician. Forcing patients to be on less effective options can result in disease persistence, progression, or irreversible damage, which lead to higher long-term medical costs as complications develop or disease worsen. Some of these costs could be incurred as time spent in emergency rooms, hospitals, rehabilitation facilities and surgical suites, demonstrably the most expensive places for medical care. Step therapy is also an administrative burden on physician practices since they or their administrators are forced to spend time advocating for the patients with insurers instead of treating patients.

The Restoring the Patient’s Voice Act, legislation introduced by Reps. Raul Ruiz, D-CA, and Brad Wenstrup, R-OH, would provide patients and providers with a clear and transparent appeals process when subject to step therapy protocols. Specifically, the legislation would do the following:

  • Establish a clear and convenient process for physicians to appeal a step therapy protocol for their patient.
  • Grant patient exceptions to step therapy under five critical circumstances such as the drug is contraindicated; the treatment is not expected to be effective; not in the best interest of the patient; and the patient is stable on another medication.
  • Expedite care by requiring a timely decision for appeals – three days or 72 hours or 24 hours if life threatening.

In addition to private payors, the Centers for Medicare and Medicaid Services (CMS) has proposed changes to Medicare Parts B and D drug and biologic coverage under the Medicare Advantage (MA) Program that AGA believes will put beneficiaries health at risk, reinforce the bad precedent set by other payers, increase administrative workloads of physician offices, and have a disruptive effect on the doctor-patient relationship.
Requiring Medicare beneficiaries to try and fail at least one and sometimes two drugs before being able to access newer and safer therapies is harmful to patients and undermines shared decision making. Yet, this is exactly how step therapy is being utilized.

Step therapy policies continue to come between doctors and their patients, and are counter to the critical doctor-patient relationship that is based on trust and focus on comfort and care. The very concept of “fail first” means a patient must suffer before they can receive the therapy that their physician recommended. Such a policy inserts an insurer or CMS between the physician and patient and is disruptive and destructive to this fundamental tenet of medicine.

AGA supports patient access to the most appropriate healthcare options. While we support efforts to improve the affordability of prescription drugs and biologics, such efforts should not be at the expense of the patient or jeopardize the doctor patient relationship. We have urged CMS to limit the use of utilization management tools such as step therapy in the Medicare program and instead to set policies and encourage novel initiatives to use resources efficiently, improve healthcare outcomes, and to preserve the valued doctor-patient relationship.