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2017 Maryland Code
Insurance
Title 15 - Health Insurance
Subtitle 1 - General Provisions
§ 15-142. Step therapy or fail-first protocol.
Universal Citation: MD Ins Code § 15-142 (2017)
- (a) Definitions. --
- (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 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.
- (4) "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) Scope of section. --
- (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.
- (1) This section applies to:
- (c) When therapy or protocol prohibited. -- 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) Coverage. -- 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) Exception. -- 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) the prescription drug is used to treat the insured's or enrollee's stage four advanced metastatic cancer; and
- (2) use of the prescription drug is:
- (i) 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
- (ii) supported by peer-reviewed medical literature.
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