(a) For the purposes of this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:

''Clinical review criteria'', as defined in section 1 of chapter 176O.

''Step therapy protocol'', a utilization management policy or program that establishes the specific sequence in which a prescription drug for a specified medical condition is covered by the division or an entity with which the division contracts to provide or manage health insurance benefits.

(b)

1. (1) Clinical review criteria used to establish a step therapy protocol shall not require an enrollee to utilize a medication that is not likely to be clinically effective for the prescribed purpose, based on peer-reviewed clinical evidence, in order for the enrollee to obtain coverage for a prescribed medication. Any requirement imposed by the division or an entity with which the division contracts to provide or manage health insurance benefits or by a utilization review organization to utilize a medication other than that prescribed shall permit the enrollee to seek an exception pursuant to subsection (c).
2. (2) When establishing clinical review criteria to be used for a step therapy protocol, the division or an entity with which the division contracts to provide or manage health insurance benefits or a utilization review organization shall take into account the needs of atypical patient populations and diagnoses.
3. (3) This section shall not require the division or an entity with which the division contracts to provide or manage health insurance benefits or a utilization review organization to establish a new entity to develop clinical review criteria used for step therapy protocols.

(c)

1. (1) If coverage of a prescription drug for the treatment of any medical condition is restricted for use directly by the division or an entity with which the division contracts to provide or manage health insurance benefits or through a utilization review organization through the use of a step therapy protocol, an enrollee and their prescribing health care provider shall have access to a clear, readily accessible and convenient process to request an exception to such step therapy protocol. An enrollee or their prescribing health care provider may request an exception to such protocol, and such request for an exception shall be granted if any of the following conditions are satisfied:

(iii) the enrollee or prescribing health care provider:

1. (A) has provided documentation to the division or an entity with which the division contracts to provide or manage health insurance benefits for the enrollee, or a utilization review organization establishing that the enrollee has previously tried the prescription drug required under the step therapy protocol, or another prescription drug in the same pharmacologic class or with the same mechanism of action, while covered by the division or an entity with which the division contracts to provide or manage health insurance benefits or by a previous health insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event;

2. (iv) the enrollee or prescribing health care provider has provided documentation to the division or an entity with which the division contracts to provide or manage health insurance benefits for the enrollee, or a utilization review organization establishing that the enrollee:

   1. (A) is stable on a prescription drug prescribed by the health care provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental harm to the enrollee.
   2. (2) The division or an entity with which the division contracts to provide or manage health insurance benefits shall have a continuity of coverage policy in place to ensure that the enrollee does not experience any delay in accessing the drug prescribed by their health care provider, including a drug administered by infusion, while the exception request is being reviewed; provided, however, that the division or an entity with which the division contracts to provide or manage health insurance benefits shall not apply any greater deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to other covered prescription drugs.
   3. (3) Upon granting an exception to the step therapy protocol pursuant to this section, the division or an entity with which the division contracts to provide health insurance benefits shall authorize coverage for the prescription drug prescribed by the enrollee's health care provider. A denial of an exception shall be eligible for appeal by an enrollee.

   4. (4) Nothing in this section shall prevent:

      1. (i) a pharmacist from effecting substitutions of prescription drugs consistent with section 12D of chapter 112; or (ii) a health care provider from prescribing a prescription drug that is determined to be medically appropriate.
      2. (d) The division or an entity with which the division contracts to provide health insurance benefits or a utilization review organization shall grant or deny a request for an exception to the step therapy protocol or a request to appeal a denial of an exception not more than 3 business days following the receipt of all necessary information to establish the medical necessity of the prescribed treatment. If additional delay would result in significant risk to the enrollee's health or well-being, the division or an entity with which the division contracts to provide health insurance benefits or a utilization review organization shall respond not more than 24 hours following the receipt of all necessary information to establish the medical necessity of the prescribed treatment. If a response by the division or an entity with which the division contracts to provide health insurance benefits or a utilization review organization is not received within the time required under this paragraph, an exception to the step therapy protocol shall be deemed granted.
      3. (e) This section shall apply to carriers that provide coverage of a prescription drug pursuant to a policy that meets the definition of a step therapy protocol, regardless of whether the policy is described as a step therapy protocol.
      4. (f) The division shall promulgate regulations necessary to implement this section.