AGA supports the Safe Step Act

AGA position: Patients should be given a clear, equitable and transparent appeals process when subjected to step therapy protocols.

In step therapy treatment, also known as ‘fail first,’ insurers require patients to try and fail medications before agreeing to cover the initial therapy prescribed by their health care provider. This practice jeopardizes the physician-patient relationship, since it bypasses what the physician believes is the best treatment for their patient. Although step therapy is used by insurers as a cost-containment mechanism, it has been shown not to save money in the long run due to complications that patients suffer, which can require additional physician visits, emergency department visits or even costly hospitalizations. With the increase of biologics to treat diseases like inflammatory bowel disease (IBD), more and more patients with digestive diseases are subject to this policy.


Requiring patients to cycle through different treatments can take time and delay access to the right treatment. These delays can ultimately lead to disease progression and even put patients at risk. In fact, a 2015 study found that 18 health plans representing 97 million lives required patients who rely on biologics or immunologic drugs to step through one or more therapies with black box safety warnings before they were able to access a safer treatment.1

Appealing step therapy protocols can be very timely and burdensome for the physician and the patient, and can take months to resolve. Some physician practices have a full-time employee devoted to navigating this process for patients, but not all practices have the resources to devote to this administrative burden.


H.R. 2279, the Safe Step Act, introduced by Reps. Raul Ruiz, D-CA and Brad Wenstrup, R-OH, both physicians, would provide a clear and timely appeals process when a patient has been subjected to step therapy. The legislation would require employer sponsored health plans to:

  • Establish a clear and convenient process for physicians to appeal a step therapy protocol for their patients.
  • Make the information on the appeals process readily available on the plan’s website including the exception requirements and any necessary forms and contact information.
  • Grant patient exceptions to step therapy under fi critical circumstances:
    • The treatment is contraindicated.
    • The treatment is expected to be ineffective.
    • The treatment will cause or is likely to cause an adverse reaction to the individual.
    • The treatment is expected to decrease the individual’s ability either to perform daily activities or occupational responsibilities or adhere to the treatment plan.
    • The individual is stable based on the prescription drugs already selected.
  • Expedite care by requiring a timely decision for appeals — three days or 72 hours or within 24 hours, if life threatening.

The Safe Step Act does not eliminate step therapy, but provides exceptions when warranted. AGA urges Congress to enact the legislation so that patients can access the most effective treatment in a timely manner and physicians are able to decide the best treatment for their patients.   

1. Branning, G., et al. “Formulary Management of Branded Drugs With And Without Boxed Warnings Within Therapeutic Categories.” Value in Health 18.3 (2015): A100.