EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb1087*
HOUSE BILL 1087
J5, J4 5lr3160
CF SB 921
By: Delegates Bhandari and Woods
Introduced and read first time: February 5, 2025
Assigned to: Health and Government Operations
A BILL ENTITLED
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 to treat a symptom of or a side effect from treatment 6
of certain metastatic cancer under certain circumstances; and generally relating to 7
step therapy and fail–first protocols and health insurance. 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
15–142. 22
(a) (1) In this section the following words have the meanings indicated. 23
2 HOUSE BILL 1087
(4) (i) “Step therapy or fail–first protocol” means a protocol established 1
by an insurer, a nonprofit health service plan, or a health maintenance organization that 2
requires a prescription drug or sequence of prescription drugs to be used by an insured or 3
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 4
is covered. 5
(ii) “Step therapy or fail–first protocol” includes a protocol that 6
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 7
or terminology used by the insurer, nonprofit health service plan, or health maintenance 8
organization to identify the protocol. 9
(b) (1) This section applies to: 10
(i) insurers and nonprofit health service plans that provide hospital, 11
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 12
health insurance policies or contracts that are issued or delivered in the State; and 13
(ii) health maintenance organizations that provide hospital, 14
medical, or surgical benefits to individuals or groups under contracts that are issued or 15
delivered in the State. 16
(2) An insurer, a nonprofit health service plan, or a health maintenance 17
organization that provides coverage for prescription drugs through a pharmacy benefits 18
manager is subject to the requirements of this section. 19
(e) An entity subject to this section may not impose a step therapy or fail–first 20
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 21
Drug Administration if: 22
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 23
stage four advanced metastatic cancer; and 24
[(2)] (II) use of the prescription drug is: 25
[(i)] 1. consistent with the U.S. Food and Drug 26
Administration–approved indication or the National Comprehensive Cancer Network 27
Drugs & Biologics Compendium indication for the treatment of stage four advanced 28
metastatic cancer; and 29
[(ii)] 2. supported by peer–reviewed medical literature; OR 30
(2) (I) THE PRESCRIPTION DRU G IS USED TO TREAT A SYMPTOM OF 31
OR A SIDE EFFECT FROM TREATMENT OF THE INSURED ’S OR ENROLLEE ’S STAGE 32
FOUR ADVANCED METASTATIC CANCER THAT THE TREATING PROVIDE R 33
DETERMINES WILL NEGA TIVELY IMPACT THE IN SURED’S OR ENROLLEE ’S HEALTH IF 34
LEFT UNTREATED ; AND 35 HOUSE BILL 1087 3
(II) USE OF THE PRESCRIPT ION DRUG IS: 1
1. CONSISTENT WITH BE ST PRACTICES FOR THE 2
TREATMENT OF STAGE FOUR ADVANCED METASTATIC CANCER, A CONDITION 3
ASSOCIATED WITH STAGE FOUR ADVANCED METASTATIC CANCER, OR A SIDE EFFECT 4
ASSOCIATED WITH STAGE FOUR ADVANCED METASTATIC CANCER TREATMENT ; AND 5
2. SUPPORTED BY PEER –REVIEWED MEDICAL 6
LITERATURE . 7
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 8
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 9
after January 1, 2026. 10
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 11
January 1, 2026. 12