Maryland HB 1087: Health Insurance - Step Therapy or Fail-First Protocols - Drugs to Treat Associated Conditions of Advanced Metastatic Cancer

Bill Text

WES MOORE, Governor Ch. 706

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Chapter 706
(House Bill 1087)

AN ACT concerning

Health Insurance – Step Therapy or Fail–First Protocols – Drugs to Treat
Associated Conditions of Advanced Metastatic Cancer

FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health
maintenance organizations from imposing a step therapy or fail–first protocol on
certain prescription drugs used prescribed by a treating physician to treat a
symptom of or a side effect from treatment of certain metastatic cancer under certain
circumstances; and generally relating to step therapy and fail–first protocols and
health insurance.

BY repealing and reenacting, without amendments,
Article – Insurance
Section 15–142(a)(1) and (4) and (b)
Annotated Code of Maryland
(2017 Replacement Volume and 2024 Supplement)

BY repealing and reenacting, with amendments,
Article – Insurance
Section 15–142(e)
Annotated Code of Maryland
(2017 Replacement Volume and 2024 Supplement)

SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:

Article – Insurance

15–142.

(a) (1) In this section the following words have the meanings indicated.

(4) (i) “Step therapy or fail–first protocol” means a protocol established
by an insurer, a nonprofit health service plan, or a health maintenance organization that
requires a prescription drug or sequence of prescription drugs to be used by an insured or
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee
is covered.

(ii) “Step therapy or fail–first protocol” includes a protocol that
meets the definition under subparagraph (i) of this paragraph regardless of the name, label,
or terminology used by the insurer, nonprofit health service plan, or health maintenance
organization to identify the protocol.

Ch. 706 2025 LAWS OF MARYLAND

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(b) (1) This section applies to:

(i) insurers and nonprofit health service plans that provide hospital,
medical, or surgical benefits to individuals or groups on an expense–incurred basis under
health insurance policies or contracts that are issued or delivered in the State; and

(ii) health maintenance organizations that provide hospital,
medical, or surgical benefits to individuals or groups under contracts that are issued or
delivered in the State.

(2) An insurer, a nonprofit health service plan, or a health maintenance
organization that provides coverage for prescription drugs through a pharmacy benefits
manager is subject to the requirements of this section.

(e) An entity subject to this section may not impose a step therapy or fail–first
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and
Drug Administration if:

(1) (I) the prescription drug is used to treat the insured’s or enrollee’s
stage four advanced metastatic cancer; and

[(2)] (II) use of the prescription drug is:

[(i)] 1. consistent with the U.S. Food and Drug
Administration–approved indication or the National Comprehensive Cancer Network
Drugs & Biologics Compendium indication for the treatment of stage four advanced
metastatic cancer; and

[(ii)] 2. supported by peer–reviewed medical literature; OR

(2) (I) THE PRESCRIPTION DRUG IS USED PRESCRIBED BY A
TREATING PHYSICIAN TO TREAT A SYMPTOM OF OR A SIDE EFFECT FROM
TREATMENT OF THE INSURED’S OR ENROLLEE’S STAGE FOUR ADVANCED
METASTATIC CANCER THAT THE TREATING PROVIDER DETERMINES WILL
NEGATIVELY IMPACT THE INSURED’S OR ENROLLEE’S HEALTH IF LEFT UNTREATED;
AND

(II) USE OF THE PRESCRIPTION DRUG IS:

1. CONSISTENT WITH BEST PRACTICES FOR THE
TREATMENT OF STAGE FOUR ADVANCED METASTATIC CANCER, A CONDITION
ASSOCIATED WITH STAGE FOUR ADVANCED METASTATIC CANCER, OR A SIDE EFFECT
ASSOCIATED WITH STAGE FOUR ADVANCED METASTATIC CANCER TREATMENT; AND

WES MOORE, Governor Ch. 706

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2. SUPPORTED BY PEER–REVIEWED MEDICAL
LITERATURE; AND

(III) THE PRESCRIPTION DRUG IS COVERED UNDER THE TERMS
OF THE POLICY OR CONTRACT OF THE INSURED OR ENROLLEE.

SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or
after January 1, 2026.

SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect
January 1, 2026.

Approved by the Governor, May 20, 2025.