Indiana Code
Chapter 8. Group Insurance for Public Employees
5-10-8-17. Step Therapy Protocol

Sec. 17. (a) As used in this section, "covered individual" means an individual entitled to coverage under a state employee health plan.
(b) As used in this section, "preceding prescription drug" means a prescription drug that, according to a step therapy protocol, must be:
(1) first used to treat a covered individual's condition; and
(2) as a result of the treatment under subdivision (1), determined to be inappropriate to treat the covered individual's condition;
as a condition of coverage under a state employee health plan for succeeding treatment with another prescription drug.
(c) As used in this section, "protocol exception" means a determination by a state employee health plan that, based on a review of a request for the determination and any supporting documentation:
(1) a step therapy protocol is not medically appropriate for treatment of a particular covered individual's condition; and
(2) the state employee health plan will:
(A) not require the covered individual's use of a preceding prescription drug under the step therapy protocol; and
(B) provide immediate coverage for another prescription drug that is prescribed for the covered individual.
(d) As used in this section, "state employee health plan" refers to the following that provide coverage for prescription drugs:
(1) A self-insurance program established under section 7(b) of this chapter.
(2) A contract with a prepaid health care delivery plan that is entered into or renewed under section 7(c) of this chapter.
The term includes a person that administers prescription drug benefits on behalf of a state employee health plan.
(e) As used in this section, "step therapy protocol" means a protocol that specifies, as a condition of coverage under a state employee health plan, the order in which certain prescription drugs must be used to treat a covered individual's condition.
(f) As used in this section, "urgent care situation" means a covered individual's injury or condition about which the following apply:
(1) If medical care or treatment is not provided earlier than the time frame generally considered by the medical profession to be reasonable for a nonurgent situation, the injury or condition could seriously jeopardize the covered individual's:
(A) life or health; or
(B) ability to regain maximum function;
based on a prudent layperson's judgment.
(2) If medical care or treatment is not provided earlier than the time frame generally considered by the medical profession to be reasonable for a nonurgent situation, the injury or condition could subject the covered individual to severe pain that cannot be adequately managed, based on the covered individual's treating health care provider's judgment.
(g) A state employee health plan shall publish on the state employee health plan's Internet web site, and provide to a covered individual in writing, a procedure for the covered individual's use in requesting a protocol exception. The procedure must include the following provisions:
(1) A description of the manner in which a covered individual may request a protocol exception.
(2) That the state employee health plan shall make a determination concerning a protocol exception request, or an appeal of a denial of a protocol exception request, not more than:
(A) in an urgent care situation, one (1) business day after receiving the request or appeal; or
(B) in a nonurgent care situation, three (3) business days after receiving the request or appeal.
(3) That a protocol exception will be granted if any of the following apply:
(A) A preceding prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the covered individual.
(B) A preceding prescription drug is expected to be ineffective, based on both of the following:
(i) The known clinical characteristics of the covered individual.
(ii) Known characteristics of the preceding prescription drug, as found in sound clinical evidence.
(C) The covered individual has previously received:
(i) a preceding prescription drug; or
(ii) another prescription drug that is in the same pharmacologic class or has the same mechanism of action as a preceding prescription drug;
and the prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event.
(D) Based on clinical appropriateness, a preceding prescription drug is not in the best interest of the covered individual because the covered individual's use of the preceding prescription drug is expected to:
(i) cause a significant barrier to the covered individual's adherence to or compliance with the covered individual's plan of care;
(ii) worsen a comorbid condition of the covered individual; or
(iii) decrease the covered individual's ability to achieve or maintain reasonable functional ability in performing daily activities.
(4) That when a protocol exception is granted, the state employee health plan shall notify the covered individual and the covered individual's health care provider of the authorization for coverage of the prescription drug that is the subject of the protocol exception.
(5) That if:
(A) a protocol exception request; or
(B) an appeal of a denied protocol exception request;
results in a denial of the protocol exception, the state employee health plan shall provide to the covered individual and the treating health care provider notice of the denial, including a detailed, written explanation of the reason for the denial and the clinical rationale that supports the denial.
(6) That the state employee health plan may request a copy of relevant documentation from the covered individual's medical record in support of a protocol exception.
As added by P.L.19-2016, SEC.1.

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