EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0646*
SENATE BILL 646
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CF 5lr2851
By: Senator Muse
Introduced and read first time: January 25, 2025
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Health Insurance – Insulin – Prohibition on Step Therapy or Fail–First 2
Protocols 3
FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 4
maintenance organizations from imposing a step therapy or fail–first protocol on 5
insulin or certain other similar medications used to treat an insured’s or enrollee’s 6
diabetes; and generally relating to use of step therapy and fail–first protocols. 7
BY repealing and reenacting, without amendments, 8
Article – Insurance 9
Section 15–142(a)(1) and (4) and (b) 10
Annotated Code of Maryland 11
(2017 Replacement Volume and 2024 Supplement) 12
BY repealing and reenacting, with amendments, 13
Article – Insurance 14
Section 15–142(e) 15
Annotated Code of Maryland 16
(2017 Replacement Volume and 2024 Supplement) 17
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 18
That the Laws of Maryland read as follows: 19
Article – Insurance 20
15–142. 21
(a) (1) In this section the following words have the meanings indicated. 22
(4) (i) “Step therapy or fail–first protocol” means a protocol established 23
by an insurer, a nonprofit health service plan, or a health maintenance organization that 24 2 SENATE BILL 646
requires a prescription drug or sequence of prescription drugs to be used by an insured or 1
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 2
is covered. 3
(ii) “Step therapy or fail–first protocol” includes a protocol that 4
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 5
or terminology used by the insurer, nonprofit health service plan, or health maintenance 6
organization to identify the protocol. 7
(b) (1) This section applies to: 8
(i) insurers and nonprofit health service plans that provide hospital, 9
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 10
health insurance policies or contracts that are issued or delivered in the State; and 11
(ii) health maintenance organizations that provide hospital, 12
medical, or surgical benefits to individuals or groups under contracts that are issued or 13
delivered in the State. 14
(2) An insurer, a nonprofit health service plan, or a health maintenance 15
organization that provides coverage for prescription drugs through a pharmacy benefits 16
manager is subject to the requirements of this section. 17
(e) An entity subject to this section may not impose a step therapy or fail–first 18
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 19
Drug Administration if: 20
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 21
stage four advanced metastatic cancer; and 22
[(2)] (II) use of the prescription drug is: 23
[(i)] 1. consistent with the U.S. Food and Drug 24
Administration–approved indication or the National Comprehensive Cancer Network 25
Drugs & Biologics Compendium indication for the treatment of stage four advanced 26
metastatic cancer; and 27
[(ii)] 2. supported by peer–reviewed medical literature; OR 28
(2) THE PRESCRIPTION DRU G IS: 29
(I) USED TO TREAT THE INSURED ’S OR ENROLLEE ’S TYPE 1, 30
TYPE 2, OR GESTATIONAL DIABE TES; AND 31
(II) 1. INSULIN; OR 32
SENATE BILL 646 3
2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 1
THAT PERFORMS A SIMI LAR FUNCTION TO INSU LIN, REGARDLESS OF THE 2
ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR AFTE R 3
DISPENSING, OR WHETHER THE DRUG IS ADMINISTERED BY I NJECTION OR 4
INHALATION. 5
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 6
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 7
after January 1, 2026. 8
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 9
January 1, 2026. 10