1. (a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review entity through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear, readily accessible and convenient process to request a step therapy exception determination. An insurer, health service corporation, health plan, or utilization review entity may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible via the insurer’s, health plan’s, or utilization review entity’s website. A step therapy exception determination shall be expeditiously granted in any one of the following circumstances:

   1. (1) The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient.
   2. (2) 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;.
   3. (3) The patient has tried the required prescription drug while under the patient’s current or previous health insurance or 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.
   4. (4) The required prescription drug is not in the best interest of the patient, based on medical necessity.
   5. (5) The patient is stable, for the medical condition under consideration, on a prescription drug selected by the patient’s health-care provider or while the patient was insured by the patient’s current or a previous insurance or health benefit plan.

2. (b) (1) The insurer, health services corporation, health plan, or utilization review entity shall grant or deny a step therapy exception request within 2 business days of receipt of such request, which shall be from a health-care provider, and which shall state the circumstance which qualifies the patient for a step therapy exception pursuant to subsection (a) of this section. A step therapy exception determination not granted or denied in writing at the end of 2 days shall be deemed granted.

   1. (2) During a step therapy exception determination under paragraph (a)(5) of this section, a determination will be deemed granted until the insurer, health services corporation, health plan, or utilization review entity issues a step therapy exception determination.
3. (c) In cases where emergency circumstances exist, as outlined in § 3565 of this title, an insurer, health plan, or utilization review entity shall grant or deny a step therapy exception request within 24 hours of receipt of a request, which shall be from a health care provider, and which shall state the circumstance which qualifies the patient for a step therapy exception pursuant to subsection (a) of this section. A request shall be deemed granted if the required response is not received by the requesting or appealing party within the times set forth in this subsection.
4. (d) Upon the granting of a step therapy exception determination, the insurer, health plan, or utilization review entity shall authorize coverage for the prescription drug prescribed by the patient’s treating health-care provider.

5. (e) This section shall not be construed to prevent:

   1. (1) An insurer, health plan, or utilization review entity from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug.
   2. (2) A health-care provider from prescribing a prescription drug that is determined to be medically necessary.

6. (f) Clinical criteria used to establish a step therapy protocol shall be based on clinical criteria that:

   1. (1) Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.

   2. (2) Developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by:

      1. a. Requiring members to disclose any potential conflict of interests with entities, including insurers, health plans, and pharmaceutical manufacturers and recuse themselves of voting if they have a conflict of interest.
      2. b. Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus.
   3. (3) Offer opportunities for public review and comments.
   4. (4) Based on peer reviewed studies, research, and medical practice.

   5. (5) Created by an explicit and transparent process that:

      1. a. Minimizes biases and conflicts of interest.
      2. b. Explains the relationship between treatment options and outcomes.
      3. c. Rates the quality of the evidence supporting recommendations.
      4. d. Considers relevant patient subgroups and preferences.
      5. e. Continually updated through a review of new evidence, research and newly developed treatments.
   6. (6) When establishing a step therapy protocol, a utilization review entity shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical criteria.
   7. (7) This section shall not be construed to require insurers, health plans or the state to set up a new entity to develop clinical review criteria used for step therapy protocols.
7. (g) Any step therapy exception determination as defined by this subsection shall be eligible for appeal by an insured or their authorized representative, as outlined in Chapter 3 and Chapter 64 of this title.

82 Del. Laws, c. 44, § 2