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2021 Policy background information

Step therapy

The American Academy of Dermatology Association (AADA) supports the Safe Step Act (H.R. 2163/S. 464), which would ensure that step therapy protocols used by health plans will preserve the physician’s right to make treatment decisions that are in the best interest of the patient.

Message to Capitol Hill

As a dermatologist, I share the concerns of the AADA that step therapy or “fail first” strategies to medication and other treatment options can negatively impact patient outcomes and quality of life. Step therapy prevents us from prescribing drugs we know will provide the best treatment results in the most expeditious manner. Requiring patients to try and fail treatments jeopardizes the health of patients who may have an adverse reaction, potentially resulting in dangerous consequences, after taking an inappropriate drug.

These protocols require our patients to try one or more prescription drugs before coverage is provided for a drug selected by the patient’s physician. The Academy understands the need to contain health care costs, but we are concerned that step therapy strategies often do not take into account:

  • a patient’s medical history,

  • whether or not the patient has already tried a certain drug and failed,

  • if a patient has a medical condition that would interfere with the efficacy of the drug,

  • if a drug’s side effects would interfere with the patient’s ability to perform their job, or

  • if the drug best for the patient is one with a different ingestion method or dosage form.

In general, patients must have access to alternative treatments if the first line option is not optimal or contraindicated. Switching therapy can promote a loss of effectiveness of the prescribed medication, especially if a patient resumes the original medication later.


Cosponsor and support passage of the Safe Step Act (H.R. 2163/S. 464), which would ensure that step therapy protocols used by health plans will preserve the physician’s right to make treatment decisions in the best interest of the patient.


Introduced by Reps. Raul Ruiz, MD, D-CA, Brad Wenstrup, R-OH, Lucy McBath, D-GA, and Mariannette Miller-Meeks, MD, R-IA in the House and Senators Lisa Murkowski, R-AK, Maggie Hassan, D-NH, Bill Cassidy, MD, R-LA, and Jacky Rosen, D-NV in the Senate, the Safe Step Act (H.R. 2163/S. 464) would ensure that step therapy protocols used by health plans will preserve the physician’s right to make treatment decisions in the best interest of the patient. Physicians know their patients’ medical history, which enables them to identify potential contraindications and life-threatening adverse reactions. Retaining physicians’ medical judgement in patients’ treatment plans is a cost-effective way to prevent health care dollars from being used on medications that are not effective. It also prevents patients from a prolonged treatment that includes scheduling multiple visits to their physician and spending money on prescription medications that are not effective.

Specifically, the Safe Step Act would amend the Employer Retirement Income Security Act (ERISA) to require group health plans to provide an exception process for any medication step therapy protocol. The bill:

  • Establishes a clear exemption process. The Safe Step Act requires insurers implement a clear and transparent process for a patient or physician to request an exception to step therapy protocol, including providing process forms and contact information on their website.

  • Outlines 5 exceptions to fail first protocols. Requires group health plans grant an exemption if an application clearly demonstrates any of the following situations:

    • Patient has already tried and failed on the required drug. A patient has already tried the medicine and failed before.

    • Delayed treatment will cause irreversible consequences. The drug is reasonably expected to be ineffective, and a delay of effective treatment would lead to severe or irreversible consequences.

    • Required drug will cause harm to the patient. The treatment is contraindicated or has caused/is likely to cause an adverse reaction.

    • Required drug will prevent a patient from working or fulfilling Activities of Daily Living (ADL). The treatment has or will prevent a participant from fulfilling their occupational responsibilities at work or performing ADL, including basic personal everyday activities such as eating, toileting, grooming, dressing, bathing, and transferring (42 CFR 441.505).

    • Patient is stable on their current medication. The patient is already stable on the prescription drug selected by his or her physician, and that drug has been covered by their previous insurance plan.

  • Requires a group health plan to respond to an exemption request within 72 hours in all circumstances, and 24 hours if the patient’s life is at risk.

More information

Step therapy is a tool used by health plans to control spending on patient medications. The AADA is concerned that step therapy or “fail first” strategies impede treatment and have been shown to have a negative impact on patients, blocking access to medications and limiting decision-making by both physicians and patients. Learn more.

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