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.
*hb1087*
HOUSE BILL 1087
J5, J4 5lr3160
CF SB 921
By: Delegates Bhandari and Woods, Woods, Alston, Bagnall, Chisholm, Cullison,
Guzzone, Hill, Hutchinson, S. Johnson, Kaiser, Kerr, Kipke, Lopez,
Martinez, M. Morgan, Pena–Melnyk, Reilly, Rosenberg, Ross, Szeliga,
Taveras, White Holland, and Woorman
Introduced and read first time: February 5, 2025
Assigned to: Health and Government Operations
Committee Report: Favorable with amendments
House action: Adopted
Read second time: March 6, 2025
CHAPTER ______
AN ACT concerning 1
Health Insurance – Step Therapy or Fail–First Protocols – Drugs to Treat 2
Associated Conditions of Advanced Metastatic Cancer 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
certain prescription drugs used prescribed by a treating physician to treat a 6
symptom of or a side effect from treatment of certain metastatic cancer under certain 7
circumstances; and generally relating to step therapy and fail–first protocols and 8
health insurance. 9
BY repealing and reenacting, without amendments, 10
Article – Insurance 11
Section 15–142(a)(1) and (4) and (b) 12
Annotated Code of Maryland 13
(2017 Replacement Volume and 2024 Supplement) 14
BY repealing and reenacting, with amendments, 15
Article – Insurance 16
Section 15–142(e) 17
Annotated Code of Maryland 18
(2017 Replacement Volume and 2024 Supplement) 19
2 HOUSE BILL 1087
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
That the Laws of Maryland read as follows: 2
Article – Insurance 3
15–142. 4
(a) (1) In this section the following words have the meanings indicated. 5
(4) (i) “Step therapy or fail–first protocol” means a protocol established 6
by an insurer, a nonprofit health service plan, or a health maintenance organization that 7
requires a prescription drug or sequence of prescription drugs to be used by an insured or 8
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 9
is covered. 10
(ii) “Step therapy or fail–first protocol” includes a protocol that 11
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 12
or terminology used by the insurer, nonprofit health service plan, or health maintenance 13
organization to identify the protocol. 14
(b) (1) This section applies to: 15
(i) insurers and nonprofit health service plans that provide hospital, 16
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 17
health insurance policies or contracts that are issued or delivered in the State; and 18
(ii) health maintenance organizations that pr ovide hospital, 19
medical, or surgical benefits to individuals or groups under contracts that are issued or 20
delivered in the State. 21
(2) An insurer, a nonprofit health service plan, or a health maintenance 22
organization that provides coverage for prescription drugs through a pharmacy benefits 23
manager is subject to the requirements of this section. 24
(e) An entity subject to this section may not impose a step therapy or fail–first 25
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 26
Drug Administration if: 27
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 28
stage four advanced metastatic cancer; and 29
[(2)] (II) use of the prescription drug is: 30
[(i)] 1. consistent with the U.S. Food and Drug 31
Administration–approved indication or the National Comprehensive Cancer Network 32
Drugs & Biologics Compendium indication for the treatment of stage four advanced 33
metastatic cancer; and 34 HOUSE BILL 1087 3
[(ii)] 2. supported by peer–reviewed medical literature; OR 1
(2) (I) THE PRESCRIPTION DRU G IS USED PRESCRIBED BY A 2
TREATING PHYSICIAN TO TREAT A SYMPTOM O F OR A SIDE EFFECT F ROM 3
TREATMENT OF THE INS URED’S OR ENROLLEE ’S STAGE FOUR ADVANCE D 4
METASTATIC CANCER THAT THE TREATING PR OVIDER DETERMINES WILL 5
NEGATIVELY IMPACT TH E INSURED’S OR ENROLLEE ’S HEALTH IF LEFT UNTREATED ; 6
AND 7
(II) USE OF THE PRESCRIPT ION DRUG IS: 8
1. CONSISTENT WITH BEST PRACTICES FOR THE 9
TREATMENT OF STAGE F OUR ADVANCED METASTA TIC CANCER, A CONDITION 10
ASSOCIATED WITH STAGE FOUR AD VANCED METASTATIC CA NCER, OR A SIDE EFFECT 11
ASSOCIATED WITH STAG E FOUR ADVANCED META STATIC CANCER TREATM ENT; AND 12
2. SUPPORTED BY PEER –REVIEWED MEDICAL 13
LITERATURE; AND 14
(III) THE PRESCRIPTION DRU G IS COVERED UNDER T HE TERMS 15
OF THE POLICY OR CONTRACT O F THE INSURED OR ENR OLLEE. 16
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 17
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 18
after January 1, 2026. 19
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 20
January 1, 2026. 21
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.