[Text of section applicable to health benefit plans delivered, issued for delivery, or renewed after October 1, 2023. See 2022, 254, Sec. 5.]

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Terms Used In Massachusetts General Laws ch. 176O sec. 12A

• Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
• Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.

Section 12A. (a) For the purposes of this section, the following term shall have the following meanings unless the context clearly requires otherwise:

”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 a carrier.

(b)(1) Clinical review criteria used to establish a step therapy protocol shall not require an insured to utilize a medication that is not likely to be clinically effective for the prescribed purpose, based on peer-reviewed clinical evidence, in order to obtain coverage for a prescribed medication. Any requirement imposed by a carrier or utilization review organization to utilize a medication other than that prescribed shall permit the insured to seek an exception to the step therapy protocol pursuant to subsection (c).

(2) When establishing clinical review criteria to be used for a step therapy protocol, a carrier or a utilization review organization shall take into account the needs of atypical patient populations and diagnoses.

(3) This section shall not require a carrier or a utilization review organization to establish a new entity to develop clinical review criteria used for step therapy protocols.

(c)(1) If coverage of a prescription drug for the treatment of any medical condition is restricted for use by a carrier directly or through a utilization review organization through the use of a step therapy protocol, the insured and 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 insured or their prescribing health care provider may request an exception to such protocol, and such request for an exception shall be granted if: (i) the prescription drug required under the step therapy protocol is contraindicated or will likely cause an adverse reaction in or physical or mental harm to the insured; (ii) the prescription drug required under the step therapy protocol is expected to be ineffective based on the known clinical characteristics of the insured and the known characteristics of the prescription drug regimen; (iii) (A) the insured or prescribing health care provider has provided documentation to the carrier or utilization review organization establishing that the insured 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,; and (B) such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the insured or prescribing health care provider has provided documentation to a carrier or utilization review organization establishing that the insured: (A) is stable on a prescription drug prescribed by their health care provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental harm to the insured.

(2) All carriers shall have a continuity of coverage policy in place to ensure that the insured 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 continuity of coverage policy shall include, but not be limited to, a 30–day fill of a United States Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the insured has already been prescribed and on which the insured is stable; and provided further, that a carrier shall not apply any greater deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to drugs covered by the plan.

(3) Upon granting an exception to the step therapy protocol, a carrier or utilization review organization shall authorize coverage for the prescription drug prescribed by the insured’s health care provider. A denial of an exception shall be eligible for appeal by an insured.

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

(d) A carrier 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 insured’s health or well-being, a carrier 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 a carrier 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.

(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.

(f) The division shall promulgate regulations necessary to implement this section.

(g) Annually, each carrier shall report to the division, in a format prescribed by the division: (i) the number of step therapy exception requests received by exception; (ii) the type of health care providers or the medical specialties of the health care providers submitting step therapy exception requests; (iii) the number of step therapy exception requests by exception that were denied and the reasons for the denials; (iv) the number of step therapy exception requests by exception that were approved; (v) the medical conditions for which patients are granted exceptions due to the likelihood that switching from the prescription drug will likely cause an adverse reaction in or physical or mental harm to the insured; (vi) the number of step therapy exception requests by exception that were initially denied and then appealed; and (vii) the number of step therapy exception requests by exception that were initially denied and then subsequently reversed by internal appeals or external reviews.