§ 27-8-5-30 — Step therapy protocol

(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.

Legislative History

As added by P.L.19-2016, SEC.3.