EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0515*
SENATE BILL 515
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By: Senator Lam
Introduced and read first time: February 3, 2023
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Health Insurance – Step Therapy or Fail–First Protocol – Revisions 2
FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 3
maintenance organizations from imposing a step therapy or fail–first protocol on an 4
insured or an enrollee for certain prescription drugs used to treat a certain mental 5
disorder or condition; requiring certain insurers, nonprofit health service plans, or 6
health maintenance organizations to establish a certain process for requesting an 7
exception to a step therapy or fail–first protocol; and generally relating to step 8
therapy or fail–first protocols and health insurance. 9
BY repealing and reenacting, with amendments, 10
Article – Insurance 11
Section 15–142 12
Annotated Code of Maryland 13
(2017 Replacement Volume and 2022 Supplement) 14
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 15
That the Laws of Maryland read as follows: 16
Article – Insurance 17
15–142. 18
(a) (1) In this section the following words have the meanings indicated. 19
(2) “Step therapy drug” means a prescription drug or sequence of 20
prescription drugs required to be used under a step therapy or fail–first protocol. 21
(3) “STEP THERAPY EXCEPTIO N REQUEST” MEANS A REQUEST TO 22
OVERRIDE A STEP THER APY OR FAIL–FIRST PROTO COL. 23 2 SENATE BILL 515
[(3)] (4) (I) “Step therapy or fail–first protocol” means a protocol 1
established by an insurer, a nonprofit health service plan, or a health maintenance 2
organization that requires a prescription drug or sequence of prescription drugs to be used 3
by an insured or an enrollee before a prescription drug ordered by a prescriber for the 4
insured or the enrollee is covered. 5
(II) “STEP THERAPY OR FAIL –FIRST PROTOCOL ” INCLUDES A 6
PROTOCOL THAT MEETS THE DEFINITION UNDER SUBPARAGRAPH (I) OF THIS 7
PARAGRAPH REGARDLESS OF THE NA ME, LABEL, OR TERMINOLOGY USED BY THE 8
INSURER, NONPROFIT HEALTH SER VICE PLAN, OR HEALTH MAINTENANC E 9
ORGANIZATION TO IDEN TIFY THE PROTOCOL . 10
[(4)] (5) “Supporting medical information” means: 11
(i) a paid claim from an entity subject to this section for an insured 12
or an enrollee; 13
(ii) a pharmacy record that documents that a prescription has been 14
filled and delivered to an insured or an enrollee, or a representative of an insured or an 15
enrollee; or 16
(iii) other information mutually agreed on by an entity subject to this 17
section and the prescriber of an insured or an enrollee. 18
(b) (1) This section applies to: 19
(i) insurers and nonprofit health service plans that provide hospital, 20
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 21
health insurance policies or contracts that are issued or delivered in the State; and 22
(ii) health maintenance organizations that provide hospital, 23
medical, or surgical benefits to individuals or groups under contracts that are issued or 24
delivered in the State. 25
(2) An insurer, a nonprofit health service plan, or a health maintenance 26
organization that provides coverage for prescription drugs through a pharmacy benefits 27
manager is subject to the requirements of this section. 28
(c) An entity subject to this section may not impose a step therapy or fail–first 29
protocol on an insured or an enrollee if: 30
(1) the step therapy drug has not been approved by the U.S. Food and Drug 31
Administration for the medical condition being treated; or 32
SENATE BILL 515 3
(2) a prescriber provides supporting medical information to the entity that 1
a prescription drug covered by the entity: 2
(i) was ordered by a prescriber for the insured or enrollee within the 3
past 180 days; and 4
(ii) based on the professional judgment of the prescriber, was 5
effective in treating the insured’s or enrollee’s disease or medical condition. 6
(d) Subsection (c) of this section may not be construed to require coverage for a 7
prescription drug that is not: 8
(1) covered by the policy or contract of an entity subject to this section; or 9
(2) otherwise required by law to be covered. 10
(e) An entity subject to this section may not impose a step therapy or fail–first 11
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 12
Drug Administration if: 13
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 14
stage four advanced metastatic cancer; and 15
[(2)] (II) use of the prescription drug is: 16
[(i)] 1. consistent with the U.S. Food and Drug 17
Administration–approved indication or the National Comprehensive Cancer Network 18
Drugs & Biologics Compendium indication for the treatment of stage four advanced 19
metastatic cancer; and 20
[(ii)] 2. supported by peer–reviewed medical literature; OR 21
(2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR 22
ENROLLEE’S MENTAL DISORDER OR CONDITION, AS DEFINED IN THE CU RRENT 23
DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS PUBLISHED B Y 24
THE AMERICAN PSYCHIATRIC ASSOCIATION, THAT RESULTS IN A SE RIOUS 25
FUNCTIONAL IMPAIRMEN T THAT SUBSTANTIALLY INTERFERES WITH OR L IMITS ONE 26
OR MORE MAJOR LIFE A CTIVITIES. 27
(F) (1) AN ENTITY SUBJECT TO THIS SECTION SHALL E STABLISH A 28
PROCESS FOR REQUESTI NG AN EXCEPTION TO A STEP THERAPY OR F AIL–FIRST 29
PROTOCOL THAT IS : 30
(I) CLEARLY DESCRIBED , INCLUDING THE SPECIF IC 31
INFORMATION AND DOCU MENTATION THAT MUST BE SUBMITTED BY THE 32 4 SENATE BILL 515
PRESCRIBER TO BE CON SIDERED A COMPLETE S TEP THERAPY EXCEPTIO N 1
REQUEST; 2
(II) EASILY ACCESSIBLE TO THE PRESCRIBER ; AND 3
(III) POSTED ON THE ENTITY ’S WEBSITE. 4
(2) A STEP THERAPY EXCEPTI ON REQUEST SHALL BE GRANTED IF, 5
BASED ON THE PROFESS IONAL JUDGMENT OF TH E PRESCRIBER: 6
(I) THE STEP THERAPY DRU G IS CONTRAINDICATED OR WILL 7
LIKELY CAUSE AN ADVE RSE REACTION, PHYSICAL HARM, OR MENTAL HARM TO TH E 8
INSURED OR ENROLLEE ; 9
(II) THE STEP THERAPY DRU G IS EXPECTED TO BE INEFFECTIVE 10
BASED ON THE KNOWN C LINICAL CHARACTERIST ICS OF THE INSURED O R ENROLLEE 11
AND THE KNOWN CHARAC TERISTICS OF THE PRE SCRIPTION DRUG REGIM EN; 12
(III) THE INSURED OR ENROL LEE IS STABLE ON A P RESCRIPTION 13
DRUG PRESCRIBED FOR THE MEDICAL CONDITIO N UNDER CONSIDERATIO N WHILE 14
COVERED UNDER THE PO LICY OR CONTRACT OF THE ENTITY OR UNDER A PREVIOUS 15
SOURCE OF COVERAGE ; OR 16
(IV) WHILE COVERED UNDER THE POLICY OR CONTRACT OF T HE 17
ENTITY OR A PREVIOUS SOURCE OF COVERAGE , THE INSURED OR ENROL LEE HAS 18
TRIED A PRESCRIPTION DRUG THAT: 19
1. IS IN THE SAME PHARM ACOLOGIC CLASS OR HA S THE 20
SAME MECHANISM OF AC TION AS THE STEP THE RAPY DRUG; AND 21
2. WAS DISCONTINUE D BY THE PRESCRIBER DUE TO 22
LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED EFFECT , OR AN ADVERSE 23
EVENT. 24
(3) AN INSURED OR ENROLLE E MAY APPEAL THE DEC ISION TO DENY 25
A STEP THERAPY EXCEP TION REQUEST UNDER T HIS SECTION. 26
(4) (I) A STEP THERAPY EXCEPTI ON REQUEST OR APPEAL SHA LL 27
BE GRANTED: 28
1. IN REAL TIME IF NO A DDITIONAL INFORMATIO N IS 29
NEEDED BY THE ENTITY TO PROCESS THE REQUE ST AND THE REQUEST M EETS THE 30
ENTITY’S CRITERIA FOR APPRO VAL; OR 31 SENATE BILL 515 5
2. IF ADDITIONAL INFORM ATION IS NEEDED BY T HE 1
ENTITY TO PR OCESS THE REQUEST AN D THE REQUEST IS NOT URGENT, WITHIN 1 2
BUSINESS DAY AFTER T HE ENTITY RECEIVES A LL RELEVANT INFORMAT ION NEEDED 3
TO PROCESS THE REQUE ST. 4
(II) IF AN ENTITY SUBJECT TO THIS SECTION DOES NOT GRANT 5
OR DENY A STEP THERA PY EXCEPTION REQUEST OR AN APPEAL WITHIN THE TIME 6
PERIOD REQUIRED UNDE R SUBPARAGRAPH (I) OF THIS PARAGRAPH , THE REQUEST 7
OR APPEAL SHALL BE T REATED AS GRANTED . 8
(5) THIS SUBSECTION MAY N OT BE CONSTRUED TO P REVENT: 9
(I) AN ENTITY SUBJECT TO THIS SECTION FROM RE QUIRING AN 10
INSURED OR ENROLLEE TO TRY AN AB–RATED GENERIC EQUIVA LENT OR 11
INTERCHANGEABLE BIOL OGICAL PRODUCT BEFOR E PROVIDING COVERAGE FOR 12
THE EQUIVALENT BRAND ED PRESCRIPTION DRUG ; OR 13
(II) A HEALTH CARE PROVID ER FROM PRESCRIBING A 14
PRESCRIPTION DRUG TH AT IS DETERMINED TO BE MEDICALLY APPR OPRIATE. 15
(6) AN ENTITY SUBJECT TO THIS SECTION MAY USE AN EXISTING STEP 16
THERAPY EXCEPTION PR OCESS THAT SATISFIES THE REQUIREMENTS UND ER THIS 17
SUBSECTION. 18
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 19
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 20
after January 1, 2024. 21
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 22
January 1, 2024. 23