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.
Italics indicate opposite chamber/conference committee amendments.
*hb0970*
HOUSE BILL 970
J5, J4 (5lr2851)
ENROLLED BILL
— Health and Government Operations/Finance —
Introduced by Delegates Woods, Alston, Bagnall, Bhandari, Chisholm, Davis,
Fisher, Ghrist, Guzzone, Harris, Harrison, Kaufman, Kerr, J. Long, Lopez,
Martinez, McCaskill, M. Morgan, Patterson, Roberts, Rosenberg, Schmidt,
Simmons, Szeliga, Taveras, Taylor, Terrasa, and Wilkins Wilkins, Cullison,
Hill, Hutchinson, S. Johnson, Kaiser, Kipke, Pena –Melnyk, Reilly, Ross,
White Holland, and Woorman
Read and Examined by Proofreaders:
_______________________________________________
Proofreader.
_______________________________________________
Proofreader.
Sealed with the Great Seal and presented to the Governor, for his approval this
_______ day of _______________ at ________________________ o’clock, ________M.
______________________________________________
Speaker.
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 an insulin analog or certain other similar medications 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 2 HOUSE BILL 970
Article – Insurance 1
Section 15–142(a)(1) and (4) and (b) 2
Annotated Code of Maryland 3
(2017 Replacement Volume and 2024 Supplement) 4
BY repealing and reenacting, with amendments, 5
Article – Insurance 6
Section 15–142(e) 7
Annotated Code of Maryland 8
(2017 Replacement Volume and 2024 Supplement) 9
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 10
That the Laws of Maryland read as follows: 11
Article – Insurance 12
15–142. 13
(a) (1) In this section the following words have the meanings indicated. 14
(4) (i) “Step therapy or fail–first protocol” means a protocol established 15
by an insurer, a nonprofit health service plan, or a health maintenance organization that 16
requires a prescription drug or sequence of prescription drugs to be used by an insured or 17
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 18
is covered. 19
(ii) “Step therapy or fail–first protocol” includes a protocol that 20
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 21
or terminology used by the insurer, nonprofit health service plan, or health maintenance 22
organization to identify the protocol. 23
(b) (1) This section applies to: 24
(i) insurers and nonprofit health service plans that provide hospital, 25
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 26
health insurance policies or contracts that are issued or delivered in the State; and 27
(ii) health maintenance organizations that provide hosp ital, 28
medical, or surgical benefits to individuals or groups under contracts that are issued or 29
delivered in the State. 30
(2) An insurer, a nonprofit health service plan, or a health maintenance 31
organization that provides coverage for prescription drugs through a pharmacy benefits 32
manager is subject to the requirements of this section. 33
HOUSE BILL 970 3
(e) An entity subject to this section may not impose a step therapy or fail–first 1
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 2
Drug Administration if: 3
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 4
stage four advanced metastatic cancer; and 5
[(2)] (II) use of the prescription drug is: 6
[(i)] 1. consistent with the U.S. Food and Drug 7
Administration–approved indication or the National Comprehensive Cancer Network 8
Drugs & Biologics Compendium indication for the treatment of stage four advanced 9
metastatic cancer; and 10
[(ii)] 2. supported by peer–reviewed medical literature; OR 11
(2) THE PRESCRIPTION DRUG IS: 12
(I) INSULIN OR AN INSULIN ANALOG USED TO TREAT THE 13
INSURED’S OR ENROLLEE ’S TYPE 1, TYPE 2, OR GESTATIONAL DIABE TES; AND 14
(II) 1. INSULIN; OR 15
2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 16
THAT PERFORMS A SIMI LAR FUNCTION TO INSULIN , REGARDLESS OF THE 17
ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR A FTER 18
DISPENSING, OR WHETHER THE DRUG IS ADMINISTERED BY I NJECTION OR 19
INHALATION. 20
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 21
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 22
after January 1, 2026. 23
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 24
January 1, 2026. 25