Step Therapy Protocol Exceptions

On June 18, 2019, Gov. Carney signed House Substitute 1 for HB 105 into law. The new law requires health plans to grant exceptions to step therapy protocols under specific circumstances. As background, step therapy protocols require patients to try one or more prescription drugs before coverage is provided for a drug selected by the patient’s health care provider.

Effective for policies issued or renewed on or after March 18, 2020, health plans must grant exceptions in the following circumstances:

  • The required prescription drug is medically inadvisable, will likely cause an adverse reaction or physical/mental harm to the patient.
  • The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen.
  • The patient has tried the required prescription drug while under the patient’s current or previous health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event.
  • The required prescription drug is not in the best interest of the patient, based on medical necessity.
  • The patient is stable, for the medical condition under consideration, on a prescription drug prescribed by the patient’s health care provider or while the patient was insured by the patient’s current or a previous health benefit plan.

HS 1 for HB 105 »