2023 Indiana Code › Title 27. Insurance › Article 13. Health Maintenance Organizations › Chapter 7. Requirements for Group Contracts, Individual Contracts, and Evidence of Coverage › 27-13-7-23. Step Therapy Protocol

Sec. 23. (a) As used in this section, "group contract" refers to a group contract that provides coverage for prescription drugs.
(b) As used in this section, "health maintenance organization" refers to a health maintenance organization that provides coverage for prescription drugs. The term includes the following:
(1) A limited service health maintenance organization.
(2) A person that administers prescription drug benefits on behalf of a health maintenance organization or a limited service health maintenance organization.
(c) As used in this section, "individual contract" refers to an individual contract 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 enrollee's condition; and
(2) as a result of the treatment under subdivision (1), determined to be inappropriate to treat the enrollee's condition;
as a condition of coverage under an individual contract or a group contract for succeeding treatment with another prescription drug.
(e) As used in this section, "protocol exception" means a determination by a health maintenance organization 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 enrollee's condition; and
(2) the health maintenance organization will:
(A) not require the enrollee'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 enrollee.
(f) As used in this section, "step therapy protocol" means a protocol that specifies, as a condition of coverage under an individual contract or a group contract, the order in which certain prescription drugs must be used to treat an enrollee's condition.
(g) As used in this section, "urgent care situation" means an enrollee'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 enrollee'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 enrollee to severe pain that cannot be adequately managed, based on the enrollee's treating health care provider's judgment.
(h) A health maintenance organization shall publish on the health maintenance organization's Internet web site, and provide to an enrollee in writing, a procedure for the enrollee's use in requesting a protocol exception. The procedure must include the following provisions:
(1) A description of the manner in which an enrollee may request a protocol exception.
(2) That the health maintenance organization 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 enrollee.
(B) A preceding prescription drug is expected to be ineffective, based on both of the following:
(i) The known clinical characteristics of the enrollee.
(ii) Known characteristics of the preceding prescription drug, as found in sound clinical evidence.
(C) The enrollee 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 enrollee because the enrollee's use of the preceding prescription drug is expected to:
(i) cause a significant barrier to the enrollee's adherence to or compliance with the enrollee's plan of care;
(ii) worsen a comorbid condition of the enrollee; or
(iii) decrease the enrollee's ability to achieve or maintain reasonable functional ability in performing daily activities.
(4) That when a protocol exception is granted, the health maintenance organization shall notify the enrollee and the enrollee'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 health maintenance organization shall provide to the enrollee 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.5.