2023 Legislative Conference: Step therapy
The American Academy of Dermatology Association (AADA) supports the Safe Step Act (H.R. 2630/S. 652), which would ensure that step therapy protocols used by group health plans preserve the physician’s right to make treatment.
Message to Capitol Hill
As a dermatologist, I share the concerns of the AADA that step therapy or “fail first” strategies for medication and treatments can negatively impact patient outcomes and quality of life. These protocols require our patients to try one or more prescription drugs before coverage is provided for the drug selected by the patient’s physician. Step therapy can ultimately cost the health care system more. Patients must have access to alternative treatments if the first line option is not optimal or contraindicated.
Cosponsor and support passage of the Safe Step Act (H.R. 2630/S. 652) and similar step therapy reform provisions included in the Pharmacy Benefit Manager (PBM) Reform Act (S. 1339), which would ensure that step therapy protocols used by group health plans preserve the physician’s right to make treatment decisions in the best interest of the patient.
The Safe Step Act (H.R. 2630/S. 652) would ensure that step therapy protocols used by group health plans preserve the physician’s right to make treatment decisions in the best interest of the patient.
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 would:
Establish a clear exemption process. The Safe Step Act requires insurers to implement a clear and transparent process for a patient or physician to request an exception to step therapy protocols, including providing process forms and contact information on their website.
Outline five 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 delaying 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 patient from fulfilling their occupational responsibilities at work or performing ADL, including basic personal everyday activities such as eating, toileting, grooming, dressing, bathing, and transferring.
Patient is stable on their current medication. The patient is already stable on the prescription drug selected by their physician, and their previous insurance plan covered that drug.
Require 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.
Senate Action: On May 11, the Senate Health, Education, Labor, and Pensions (HELP) Committee included the Safe Step Act (S. 652) in the Pharmacy Benefit Manager Reform Act (S. 1339), legislation intended to increase oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. The full Senate has not yet considered the bill. Senators can still cosponsor the bill as a sign of support.
House Action: The House still needs to act on the bill.
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