§ 27-13-7-23 — Step therapy protocol

Indiana § 27-13-7-23

• Jurisdiction: Indiana
• Title 27: INSURANCE
• Art. 13: HEALTH MAINTENANCE ORGANIZATIONS
• Ch. 7: Requirements for Group Contracts, Individual Contracts,

Text

(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.

Legislative History

As added by P.L.19-2016, SEC.5.