Sec. 31.5. (a) This section applies to a policy of accident and sickness insurance that is issued, entered into, amended, or renewed after June 30, 2020.

     (b) The definitions in section 30 of this chapter apply throughout this section.

     (c) This section applies to an insurer that uses a formulary or cost sharing review for prescription drug coverage.

     (d) An insurer shall not remove a prescription drug from the insurer’s formulary or change the cost sharing requirements that apply to a prescription drug unless the insurer does the following:

(1) At least sixty (60) days before the removal or change is effective, sends written notice of the removal or change to each insured for whom the prescription drug has been prescribed during the plan year.

(2) Provides a timely appeal process through which an insured may request an extension of coverage for the prescription drug through the end of the plan year. The appeal process must consider the following:

(A) Clinical appropriateness that is evidence based.

(B) Whether the insured has been adherent to the prescription drug regimen long enough that discontinuation of the prescription drug would cause a significant barrier to the insured’s adherence to or compliance with the insured’s plan of care.

(C) Whether discontinuation of the prescription drug would worsen a comorbid condition of the insured.

(D) Whether discontinuation of the prescription drug would decrease the insured’s ability to achieve or maintain reasonable functional ability to perform daily activities.

     (e) If the request for an extension made by an insured under subsection (d) is supported by documentation from the prescribing health care provider, the insurer shall make a determination concerning the insured’s request:

(1) in an urgent care situation, not more than one (1) business day after receiving the request; or

(2) in a non-urgent situation, not more than three (3) business days after receiving the request.

     (f) If an appeal under subsection (d)(2) 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 was the subject of the appeal.

     (g) An extension of coverage of a prescription drug through the end of the plan year under this section is permitted only once and may not be repeated unless otherwise provided by the insurer.

     (h) Nothing under this section prohibits an insurer from removing a prescription drug from its formulary or denying an insured coverage if:

(1) the federal Food and Drug Administration has issued a statement about the prescription drug that calls into question the clinical safety of the prescription drug;

(2) the manufacturer of the prescription drug has notified the federal Food and Drug Administration of a manufacturing discontinuance or potential discontinuance of the prescription drug as required by 21 U.S.C. § 356c of the federal Food, Drug, and Cosmetic Act; or

(3) the manufacturer of the prescription drug has removed the prescription drug from the market.

     (i) This chapter does not prohibit a pharmacist from substituting:

(1) a generically equivalent drug product for a brand name drug under IC 16-42-22; or

(2) a biosimilar biological product for a prescribed biological product under 16-42-25.

As added by P.L.114-2020, SEC.19.