EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
*sb0646*
SENATE BILL 646
J5, J4 5lr2852
CF HB 970
By: Senator Muse
Introduced and read first time: January 25, 2025
Assigned to: Finance
Committee Report: Favorable with amendments
Senate action: Adopted
Read second time: March 11, 2025
CHAPTER ______
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 or an insulin analog used to treat an 6
insured’s or enrollee’s diabetes; and generally relating to use of step therapy and 7
fail–first protocols. 8
BY repealing and reenacting, without amendments, 9
Article – Insurance 10
Section 15–142(a)(1) and (4) and (b) 11
Annotated Code of Maryland 12
(2017 Replacement Volume and 2024 Supplement) 13
BY repealing and reenacting, with amendments, 14
Article – Insurance 15
Section 15–142(e) 16
Annotated Code of Maryland 17
(2017 Replacement Volume and 2024 Supplement) 18
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 19
That the Laws of Maryland read as follows: 20
Article – Insurance 21 2 SENATE BILL 646
15–142. 1
(a) (1) In this section the following words have the meanings indicated. 2
(4) (i) “Step therapy or fail–first protocol” means a protocol established 3
by an insurer, a nonprofit health service plan, or a health maintenance organization that 4
requires a prescription drug or sequence of prescription drugs to be used by an insured or 5
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 6
is covered. 7
(ii) “Step therapy or fail–first protocol” includes a protocol that 8
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 9
or terminology used by the insurer, nonprofit health service plan, or health maintenance 10
organization to identify the protocol. 11
(b) (1) This section applies to: 12
(i) insurers and nonprofit health service plans that provide hospital, 13
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 14
health insurance policies or contracts that are issued or delivered in the State; and 15
(ii) health maintenance organizations that provide hospital, 16
medical, or surgical benefits to individuals or groups under contracts that are issued or 17
delivered in the State. 18
(2) An insurer, a nonprofit health service plan, or a health maintenance 19
organization that provides coverage for prescription drugs through a pharmacy benefits 20
manager is subject to the requirements of this section. 21
(e) An entity subject to this section may not impose a step therapy or fail–first 22
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 23
Drug Administration if: 24
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 25
stage four advanced metastatic cancer; and 26
[(2)] (II) use of the prescription drug is: 27
[(i)] 1. consistent with the U.S. Food and Drug 28
Administration–approved indication or the National Comprehensive Cancer Network 29
Drugs & Biologics Compendium indication for the treatment of stage four advanced 30
metastatic cancer; and 31
[(ii)] 2. supported by peer–reviewed medical literature; OR 32
(2) THE PRESCRIPTION DRU G IS: 33 SENATE BILL 646 3
(I) INSULIN OR AN INSULI N ANALOG USED TO TREAT THE 1
INSURED’S OR ENROLLEE ’S TYPE 1, TYPE 2, OR GESTATIONAL DIABETES ; AND 2
(II) 1. INSULIN; OR 3
2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 4
THAT PERFORMS A SIMI LAR FUNCTION TO INSU LIN, REGARDLESS OF THE 5
ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR A FTER 6
DISPENSING, OR WHETHER TH E DRUG IS ADMINISTER ED BY INJECTION OR 7
INHALATION. 8
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 9
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 10
after January 1, 2026. 11
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 12
January 1, 2026. 13
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
President of the Senate.
________________________________________________________________________________
Speaker of the House of Delegates.