Indiana Code
Chapter 5. Accident and Sickness Insurance─policy Provisions
27-8-5-30. Step Therapy Protocol

Sec. 30. (a) As used in this section, "insured" means an individual who is entitled to coverage under a policy of accident and sickness insurance.
(b) As used in this section, "insurer" refers to an insurer that issues a policy of accident and sickness insurance. The term includes a person that administers prescription drug benefits on behalf of an insurer.
(c) As used in this section, "policy of accident and sickness insurance" means a policy of accident and sickness insurance that provides coverage for prescription drugs.
(d) 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 an insured's condition; and
(2) as a result of the treatment under subdivision (1), determined to be inappropriate to treat the insured's condition;
as a condition of coverage under a policy of accident and sickness insurance for succeeding treatment with another prescription drug.
(e) As used in this section, "protocol exception" means a determination by an insurer 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 insured's condition; and
(2) the insurer will:
(A) not require the insured'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 insured.
(f) As used in this section, "step therapy protocol" means a protocol that specifies, as a condition of coverage under a policy of accident and sickness insurance, the order in which certain prescription drugs must be used to treat an insured's condition.
(g) As used in this section, "urgent care situation" means an insured'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 insured'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 insured to severe pain that cannot be adequately managed, based on the insured's treating health care provider's judgment.
(h) An insurer shall publish on the insurer's Internet web site, and provide to an insured in writing, a procedure for the insured's use in requesting a protocol exception. The procedure must include the following provisions:
(1) A description of the manner in which an insured may request a protocol exception.
(2) That the insurer 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 insured.
(B) A preceding prescription drug is expected to be ineffective, based on both of the following:
(i) The known clinical characteristics of the insured.
(ii) Known characteristics of the preceding prescription drug, as found in sound clinical evidence.
(C) The insured 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 insured because the insured's use of the preceding prescription drug is expected to:
(i) cause a significant barrier to the insured's adherence to or compliance with the insured's plan of care;
(ii) worsen a comorbid condition of the insured; or
(iii) decrease the insured's ability to achieve or maintain reasonable functional ability in performing daily activities.
(4) That when a protocol exception is granted, the insurer shall notify the insured and the insured'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 insurer shall provide to the insured 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 insurer may request a copy of relevant documentation from the insured's medical record in support of a protocol exception.
As added by P.L.19-2016, SEC.3.

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