Step-therapy protocol – limitations – exceptions – definitions – rules
(a) “Biosimilar” has the meaning set forth in 42 USC Sec. 262 (i)(2).
(b) “Clinical practice guidelines” means a systematically developed statement to assist providers and covered persons in making decisions about appropriate health care for specific clinical circumstances and conditions.
(c) “Clinical review criteria” means the written screening procedures, decision abstracts, clinical protocols, and clinical practice guidelines used by a carrier or private utilization review organization to determine the medical necessity and appropriateness of the provision of health-care services. clinical review criteria must not be more restrictive than the FDA’s indication for a specific drug or health-care service.
(d) “Exigent circumstance” means a circumstance in which a covered person is suffering from a health condition that may seriously jeopardize the covered person’s life, health, or ability to regain maximum functions.
(e) “Medical necessity” has the same meaning as set forth in section 10-16-112.5.
(f) “Private utilization review organization” or “organization” has the same meaning as set forth in section 10-16-112 (1)(a).
(g) “Step therapy” means a protocol that requires a covered person to use a prescription drug or sequence of prescription drugs, other than the drug that the covered person’s health-care provider recommends for the covered person’s treatment, before the carrier provides coverage for the recommended prescription drug.
(2) If a carrier, a private utilization review organization, or a PBM requires step therapy, the carrier, organization, or PBM shall use clinical review criteria to establish the protocol for step therapy based on clinical practice guidelines.
(3) A carrier, private utilization review organization, or PBM shall:
(a) make the clinical review criteria and the step therapy exemption process available on their websites; and
(b) upon written request, provide all specific clinical review criteria and other clinical information relating to a covered person’s particular condition or disease, including clinical review criteria relating to a step-therapy exception, to the requester.
(4) (a) A carrier, a private utilization review organization, or a PBM shall grant an exception to step therapy if the prescribing provider submits justification and supporting clinical documentation, if needed, that states:
(I) the provider attests that the required prescription drug is contraindicated or will likely cause an adverse reaction or harm to the covered person;
(II) the required prescription drug is ineffective based on the known clinical characteristics of the covered person and the known characteristics of the prescription drug regimen;
(III) the covered person has tried, while under the covered person’s current or previous health benefit plan, the required prescription drug or another prescription drug in the same pharmacologic class or with the same mechanism of action, and the use of the prescription drug by the covered person was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
(IV) the covered person, while on the covered person’s current or previous health benefit plan, is stable on a prescription drug selected by the prescribing provider for the medical condition under consideration after undergoing step therapy or after having sought and received a step-therapy exception.
(b)(I) Except as provided in subsection (4)(b)(ii) of this section, a carrier, organization, or PBM shall grant or deny a step therapy exception request or an appeal of a denial of a request within:
(A) three business days after receipt of the request; or
(B) in cases where exigent circumstances exist, within twenty-four hours after receipt of the request.
(II) If a request for a step therapy exception or an appeal of a denial of a request is incomplete or if additional clinically relevant information is required, the carrier, organization, or PBM shall notify the prescribing provider within seventy-two hours after submission of the request, or within twenty-four hours after the submission of the request if exigent circumstances exist, that the request or appeal is incomplete or that additional clinically relevant information is required. the carrier, organization, or PBM must specify the additional information that is required in order to consider the step therapy exception request or the appeal of the denial of the request pursuant to the criteria described in subsection (4)(a) of this section. once the requested information is submitted to the carrier, organization, or PBM, the applicable period to grant or deny a step therapy exception request or an appeal of a denial of a request, as specified in subsection (4)(b)(i) of this section, applies.
(III) If a carrier, organization, or PBM does not make a determination regarding the step therapy exception request or the appeal of the denial of the request or does not make a request for additional or clinically relevant information within the required time, the step therapy exception request or the appeal of the denial of the request is deemed granted.
(c) If the initial request for a step-therapy exception is denied, the carrier, organization, or PBM shall inform the covered person in writing that the covered person has the right to an internal or external review or an appeal of the adverse determination pursuant to sections 10-16-113 and 10-16-113.5.
(d) A carrier, an organization, or a PBM shall authorize coverage for the prescription drug prescribed by the covered person’s prescribing provider when the step-therapy exception request is granted.
(5) This section does not prohibit:
(a) A carrier, an organization, or a PBM from requiring a covered person to try a generic equivalent drug, a biosimilar drug, or an interchangeable biological product as defined by 42 USC sec. 262 (i)(3), unless the covered person or covered person’s prescribing provider has requested a step-therapy exception and the prescribed drug meets the criteria for a step-therapy exception specified in subsection (4)(a) of this section;
(b) a carrier, an organization, or a PBM from requiring a pharmacist to make substitutions of prescription drugs consistent with Part 5 of Article 280 of Title 12; or
(c) a provider from prescribing a drug that is determined to be medically appropriate.
(6) The commissioner may promulgate rules to implement and enforce this section.