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.
IMPACT OF STEP THERAPY ON PATIENTSRequiring 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.
THE SAFE STEP ACTH.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.
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.