(a) (1) In this section the following words have the meanings indicated.
(2) “Step therapy drug” means a prescription drug or sequence of prescription drugs required to be used under a step therapy or fail–first protocol.
(3) “Step therapy exception request” means a request to override a step therapy or fail–first protocol.
(4) (i) “Step therapy or fail–first protocol” means a protocol established by an insurer, a nonprofit health service plan, or a health maintenance organization that requires a prescription drug or sequence of prescription drugs to be used by an insured or an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee is covered.
(ii) “Step therapy or fail–first protocol” includes a protocol that meets the definition under subparagraph (i) of this paragraph regardless of the name, label, or terminology used by the insurer, nonprofit health service plan, or health maintenance organization to identify the protocol.
(5) “Supporting medical information” means:
(i) a paid claim from an entity subject to this section for an insured or an enrollee;
(ii) a pharmacy record that documents that a prescription has been filled and delivered to an insured or an enrollee, or a representative of an insured or an enrollee; or
(iii) other information mutually agreed on by an entity subject to this section and the prescriber of an insured or an enrollee.
(b) (1) This section applies to:
(i) insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and
(ii) health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State.
(2) An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section.
(c) An entity subject to this section may not impose a step therapy or fail–first protocol on an insured or an enrollee if:
(1) the step therapy drug has not been approved by the U.S. Food and Drug Administration for the medical condition being treated; or
(2) a prescriber provides supporting medical information to the entity that a prescription drug covered by the entity:
(i) was ordered by a prescriber for the insured or enrollee within the past 180 days; and
(ii) based on the professional judgment of the prescriber, was effective in treating the insured’s or enrollee’s disease or medical condition.
(d) Subsection (c) of this section may not be construed to require coverage for a prescription drug that is not:
(1) covered by the policy or contract of an entity subject to this section; or
(2) otherwise required by law to be covered.
(e) An entity subject to this section may not impose a step therapy or fail–first protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and Drug Administration if:
(1) (i) the prescription drug is used to treat the insured’s or enrollee’s stage four advanced metastatic cancer; and
(ii) use of the prescription drug is:
1. consistent with the U.S. Food and Drug Administration–approved indication or the National Comprehensive Cancer Network Drugs & Biologics Compendium indication for the treatment of stage four advanced metastatic cancer; and
2. supported by peer–reviewed medical literature;
(2) the prescription drug is insulin or an insulin analog used to treat the insured’s or enrollee’s type 1, type 2, or gestational diabetes; or
(3) (i) the prescription drug is prescribed by a treating physician to treat a symptom of or a side effect from treatment of the insured’s or enrollee’s stage four advanced metastatic cancer;
(ii) use of the prescription drug is:
1. consistent with best practices for the treatment of stage four advanced metastatic cancer, a condition associated with stage four advanced metastatic cancer, or a side effect associated with stage four advanced metastatic cancer treatment; and
2. supported by peer–reviewed medical literature; and
(iii) the prescription drug is covered under the terms of the policy or contract of the insured or enrollee.
(f) (1) An entity subject to this section shall establish a process for requesting an exception to a step therapy or fail–first protocol that is:
(i) clearly described, including the specific information and documentation, if needed, that must be submitted by the prescriber to be considered a complete step therapy exception request;
(ii) easily accessible to the prescriber; and
(iii) posted on the entity’s website.
(2) A step therapy exception request shall be granted if, based on the professional judgment of the prescriber and any information and documentation required under paragraph (1)(i) of this subsection:
(i) the step therapy drug is contraindicated or will likely cause an adverse reaction to the insured or enrollee;
(ii) the step therapy drug is expected to be ineffective based on the known clinical characteristics of the insured or enrollee and the known characteristics of the prescription drug regimen;
(iii) the insured or enrollee is stable on a prescription drug prescribed for the medical condition under consideration while covered under the policy or contract of the entity or under a previous source of coverage; or
(iv) while covered under the policy or contract of the entity or a previous source of coverage, the insured or enrollee has tried a prescription drug that:
1. is in the same pharmacologic class or has the same mechanism of action as the step therapy drug; and
2. was discontinued by the prescriber due to lack of efficacy or effectiveness, diminished effect, or an adverse event.
(3) On granting a step therapy exception request, an entity subject to this section shall authorize coverage for the prescription drug ordered by the prescriber for an insured or enrollee.
(4) An enrollee or insured may appeal a step therapy exception request denial in accordance with Subtitle 10A or Subtitle 10B of this title.
(5) This subsection may not be construed to:
(i) prevent:
1. an entity subject to this section from requiring an insured or enrollee to try an AB–rated generic equivalent or interchangeable biological product before providing coverage for the equivalent branded prescription drug; or
2. a health care provider from prescribing a prescription drug that is determined to be medically appropriate; or
(ii) require an entity subject to this section to provide coverage for a prescription drug that is not covered by a policy or contract of the entity.
(6) An entity subject to this section may use an existing step therapy exception process that satisfies the requirements under this subsection.