§ 27-8-5-31.5 — Insurer removing prescription drug from formulary or changing cost sharing; written notice and appeal process

Indiana § 27-8-5-31.5

• Jurisdiction: Indiana
• Title 27: INSURANCE
• Art. 8: LIFE, ACCIDENT, AND HEALTH
• Ch. 5: Accident and Sickness Insurance─Policy Provisions

Text

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.

Legislative History

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