WES MOORE, Governor Ch. 364
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Chapter 364
(Senate Bill 515)
AN ACT concerning
Health Insurance – Step Therapy or Fail–First Protocol – Revisions
FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health
maintenance organizations from imposing a step therapy or fail–first protocol on an
insured or an enrollee for certain prescription drugs used to treat a certain mental
disorder or condition; requiring certain insurers, nonprofit health service plans, or
health maintenance organizations to establish a certain process for requesting an
exception to a step therapy or fail–first protocol; prohibiting certain insurers,
nonprofit health service plans, health maintenance organizations, and pharmacy
benefits managers from requiring more than a certain number of prior
authorizations for a prescription for different dosages of the same prescription drug;
requiring a private review agent to make a determination on a step therapy
exception request or prior authorization request submitted electronically within a
certain period of time; and generally relating to step therapy or fail–first protocols
and prior authorizations and health insurance.
BY repealing and reenacting, with amendments,
Article – Insurance
Section 15–142 and 15–10B–06(a)
Annotated Code of Maryland
(2017 Replacement Volume and 2022 Supplement)
BY repealing and reenacting, without amendments,
Article – Insurance
Section 15–854(a)
Annotated Code of Maryland
(2017 Replacement Volume and 2022 Supplement)
BY adding to
Article – Insurance
Section 15–854(g)
Annotated Code of Maryland
(2017 Replacement Volume and 2022 Supplement)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Insurance
15–142.
Ch. 364 2023 LAWS OF MARYLAND
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(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 EXCEPTIO N REQUEST” MEANS A REQUEST TO
OVERRIDE A STEP THER APY OR FAIL–FIRST PROTOCOL .
[(3)] (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 SER VICE PLAN, OR HEALTH MAINTENAN CE
ORGANIZATION TO IDEN TIFY THE PROTOCOL .
[(4)] (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. WES MOORE, Governor Ch. 364
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(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
[(2)] (II) use of the prescription drug is:
[(i)] 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
[(ii)] 2. supported by peer–reviewed medical literature; OR
(2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR
ENROLLEE’S MENTAL DISORDER OR CONDITION, AS DEFINED IN THE CU RRENT
DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS PUBLISHED B Y
THE AMERICAN PSYCHIATRIC ASSOCIATION, THAT RESULTS IN A SE RIOUS
FUNCTIONAL IMPAIRMEN T THAT SUBSTANTIALLY INTERFERES WITH OR L IMITS ONE
OR MORE MAJOR LIFE A CTIVITIES.
Ch. 364 2023 LAWS OF MARYLAND
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(F) (1) AN ENTITY SUBJECT TO THIS SECTION SHALL E STABLISH A
PROCESS FOR REQUESTI NG AN EXCEPTION TO A STEP THERAPY OR FAIL –FIRST
PROTOCOL THAT IS :
(I) CLEARLY DESCRIBED , INCLUDING THE SPECIF IC
INFORMATION AND DOCU MENTATION, IF NEEDED, THAT MUST BE SUBMITTED BY
THE PRESCRIBER TO BE CON SIDERED A COMPLETE S TEP THERAPY EXCEPTIO N
REQUEST;
(II) EASILY ACCESSIBLE TO THE PRESCRIBER ; AND
(III) POSTED ON THE ENTITY ’S WEBSITE.
(2) A STEP THERAPY EXCEPTI ON REQUEST SHALL BE GRANTED IF,
BASED O N THE PROFESSIONAL J UDGMENT OF THE PRESC RIBER AND ANY
INFORMATION AND DOCU MENTATION REQUIRED U NDER PARAGRAPH (1)(I) OF THIS
SUBSECTION:
(I) THE STEP THERAPY DRU G IS CONTRAINDICATED OR WILL
LIKELY CAUSE AN ADVE RSE REACTION, PHYSICAL HARM , OR MENTAL HARM TO THE
INSURED OR ENROLLEE ;
(II) THE STEP THERAPY DRU G IS EXPECTED TO BE INEFFECTIVE
BASED ON THE KNOWN C LINICAL CHARACTERIST ICS OF THE INSURED O R ENROLLEE
AND THE KNOWN CHARAC TERISTICS OF THE PRE SCRIPTION DRUG REGIM EN;
(III) THE INSURED OR ENROL LEE IS STABLE ON A PR ESCRIPTION
DRUG PRESCRIBED FOR THE MEDICAL CONDITIO N UNDER CONSIDERATIO N WHILE
COVERED UNDER THE PO LICY OR CONTRACT OF THE ENTITY OR UNDER A PREVIOUS
SOURCE OF COVERAGE ; OR
(IV) WHILE COVERED UNDER THE POLICY OR CONTRA CT OF THE
ENTITY OR A PREVIOUS SOU RCE OF COVERAGE , THE INSURED OR ENROL LEE HAS
TRIED A PRESCRIPTION DRUG THAT:
1. IS IN THE SAME PHARM ACOLOGIC CLASS OR HA S THE
SAME MECHANISM OF AC TION AS THE STEP THE RAPY DRUG; AND
2. WAS DISCONTINUED BY THE PRESCRIBER DUE T O
LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED EFFECT , OR AN ADVERSE
EVENT.
WES MOORE, Governor Ch. 364
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(3) AN INSURED OR ENROLLE E MAY APPEAL THE DEC ISION TO DENY
A STEP THERAPY EXCEP TION REQUEST UNDER T HIS SECTION.
(4) (I) A STEP THERAPY EXCEPTION REQUES T OR APPEAL SHALL
BE GRANTED:
1. IN REAL TIME IF NO A DDITIONAL INFORMATIO N IS
NEEDED BY THE ENTITY TO PROCESS THE REQUE ST AND THE REQUEST M EETS THE
ENTITY’S CRITERIA FOR APPRO VAL; OR
2. IF ADDITIONAL INFORM ATION IS NEEDED BY T HE
ENTITY TO PROCESS TH E REQUEST AND THE RE QUEST IS NOT URGENT , WITHIN 1
BUSINESS DAY AFTER T HE ENTITY RECEIVES A LL RELEVANT INFORMAT ION NEEDED
TO PROCESS THE REQUE ST.
(II) IF AN ENTITY SUBJECT TO THIS SECTION DOES NOT GRANT
OR DENY A STEP THERA PY EXCEPTION REQUEST OR AN APPEAL WITHIN THE TIME
PERIOD REQUIRED UNDE R SUBPARAGRAPH (I) OF THIS PARAGRAPH , THE REQUEST
OR APPEAL SHALL BE T REATED AS GRANTED .
(3) ON GRANTING A STEP TH ERAPY EXCEPTION REQU EST, AN ENTITY
SUBJECT TO THIS SECT ION SHALL AUTHORIZE COVERAGE F OR THE PRESCRIPTION
DRUG ORDERED BY THE PRESCRIBER FOR AN IN SURED OR ENROLLEE .
(4) AN ENROLLEE OR INSURE D MAY APPEAL A STEP THERAPY
EXCEPTION REQUEST DE NIAL IN ACCORDANCE W ITH SUBTITLE 10A OR SUBTITLE
10B OF THIS TITLE.
(5) THIS SUBSECTION MAY NOT B E CONSTRUED TO PREVENT:
(I) PREVENT:
1. AN ENTITY SUBJECT TO THIS SECTION FROM
REQUIRING AN INSURED OR ENROLLEE TO TRY A N AB–RATED GENERIC
EQUIVALENT OR INTERC HANGEABLE BIOLOGICAL PRODUCT BEFORE PROVI DING
COVERAGE FOR THE EQUIVALENT BRANDED P RESCRIPTION DRUG ; OR
(II) 2. A HEALTH CARE PROVID ER FROM PRESCRIBING A
PRESCRIPTION DRUG TH AT IS DETERMINED TO BE MEDICALLY APPROPR IATE; OR
(II) REQUIRE AN ENTITY SU BJECT TO THIS SECTIO N TO
PROVIDE COVERAGE FOR A PRESCRIPTION DR UG THAT IS NOT COVER ED BY A
POLICY OR CONTRACT O F THE ENTITY.
Ch. 364 2023 LAWS OF MARYLAND
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(6) AN ENTITY SUBJECT TO THIS SECTION MAY USE AN EXISTING STEP
THERAPY EXCEPTION PR OCESS THAT SATISFIES THE REQUIREMENTS UND ER THIS
SUBSECTION.
15–854.
(a) (1) This section applies to:
(i) insurers and nonprofit health service plans that provide coverage
for prescription drugs through a pharmacy benefit under individual, group, or blanket
health insurance policies or contracts that are issued or delivered in the State; and
(ii) health maintenance organizations that provide coverage for
prescription drugs through a pharmacy benefit under individual or group 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 or that contracts with a private review agent under Subtitle 10B of this article is
subject to the requirements of this section.
(3) This section does not apply to a managed care organization as defined
in § 15–101 of the Health – General Article.
(G) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION ,
AN ENTITY SUBJECT TO THIS SECTION MAY NOT REQUIRE MORE THAN ON E PRIOR
AUTHORIZATION IF T WO OR MORE TABLETS O F DIFFERENT DOSAGE S TRENGTHS OF
THE SAME PRESCRIPTIO N DRUG ARE:
(I) PRESCRIBED AT THE SA ME TIME AS PART OF A N INSURED’S
TREATMENT PLAN ; AND
(II) MANUFACTURED BY THE SAME MANUFACTURER .
(2) THIS SUBSECTION DOES NOT PROHIBIT AN ENTITY FROM
REQUIRING MORE THAN ONE PRIOR AUTHORIZAT ION IF THE PRESCRIPT ION IS FOR
TWO OR MORE TABLETS OF DIFFERENT DOSAGE STRENGTHS OF AN OPIO ID THAT IS
NOT AN OPIOID PARTIA L AGONIST.
15–10B–06.
(a) (1) [A] EXCEPT AS PROVIDED IN PARAGRAPH (4) OF THIS
SUBSECTION, A private review agent shall:
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(i) make all initial determinations on whether to authorize or certify
a nonemergency course of treatment for a patient within 2 working days after receipt of the
information necessary to make the determination;
(ii) make all determinations on whether to authorize or certify an
extended stay in a health care facility or additional health care services within 1 working
day after receipt of the information necessary to make the determination; and
(iii) promptly notify the health care provider of the determination.
(2) If within 3 calendar days after receipt of the initial request for health
care services the private review agent does not have sufficient information to make a
determination, the private review agent shall inform the health care provider that
additional information must be provided.
(3) If a private review agent requires prior authorization for an emergency
inpatient admission, or an admission for residential crisis services as defined in § 15–840
of this title, for the treatment of a mental, emotional, or substance abuse disorder, the
private review agent shall:
(i) make all determinations on whether to authorize or certify an
inpatient admission, or an admission for residential crisis services as defined in § 15–840
of this title, within 2 hours after receipt of the information necessary to make the
determination; and
(ii) promptly notify the health care provider of the determination.
(4) FOR A STEP THERAPY EX CEPTION REQUEST SUBM ITTED
ELECTRONICALLY IN AC CORDANCE WITH A PROC ESS ESTABLISHED UNDE R §
15–142(F) OF THIS TITLE OR A P RIOR AUTHORIZATION R EQUEST SUBMITTED
ELECTRONICALLY FOR P HARMACEUTICAL SERVIC ES, A PRIVATE REVIEW AGE NT
SHALL MAKE A DETERMI NATION:
(I) IN REAL TIME IF:
1. NO ADDITIONAL INFORM ATION IS NEEDED BY T HE
PRIVATE REVIEW AGENT TO PROCESS THE REQUE ST; AND
2. THE REQUEST MEETS TH E PRIVATE REVIEW AGE NT’S
CRITERIA FOR APPROVA L; OR
(II) IF A REQUEST IS NOT APPROVED UNDER I TEM (I) OF THIS
PARAGRAPH , WITHIN 1 BUSINESS DAY AFTER T HE PRIVATE REVIEW AG ENT
RECEIVES ALL OF THE INFORMATION NECESSAR Y TO MAKE THE DETERM INATION.
Ch. 364 2023 LAWS OF MARYLAND
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SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or
after January 1, 2024.
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect
January 1, 2024.
Approved by the Governor, May 3, 2023.