EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
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SENATE BILL 990
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By: Senator Lam
Introduced and read first time: February 2, 2024
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Maryland Medical Assistance Program and Health Ins urance – Step Therapy, 2
Fail–First Protocols, and Prior Authorization – Prescription Drugs to Treat 3
Serious Mental Illness 4
FOR the purpose of prohibiting the Maryland Medical Assistance Program and certain 5
insurers, nonprofit health service plans, health maintenance organizations, and 6
managed care organizations from applying a prior authorization requirement, step 7
therapy protocol, or fail–first protocol for prescription drugs used to treat certain 8
mental illnesses; and generally relating to health insurance and coverage of 9
prescription drugs to treat serious mental illness. 10
BY adding to 11
Article – Health – General 12
Section 15–102.3(m) and 15–155 13
Annotated Code of Maryland 14
(2023 Replacement Volume) 15
BY repealing and reenacting, with amendments, 16
Article – Insurance 17
Section 15–142 18
Annotated Code of Maryland 19
(2017 Replacement Volume and 2023 Supplement) 20
BY adding to 21
Article – Insurance 22
Section 15–851.1 23
Annotated Code of Maryland 24
(2017 Replacement Volume and 2023 Supplement) 25
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 26
That the Laws of Maryland read as follows: 27 2 SENATE BILL 990
Article – Health – General 1
15–102.3. 2
(M) THE PROVISIONS OF §§ 15–142(E)(2) AND 15–851.1 OF THE INSURANCE 3
ARTICLE APPLY TO MANA GED CARE ORGANIZATIO NS. 4
15–155. 5
BEGINNING JULY 1, 2024, THE PROGRAM MAY NOT APPLY A PRIOR 6
AUTHORIZATION REQUIR EMENT, FAIL–FIRST PROTOCOL, OR STEP THERAPY 7
PROTOCOL FOR A PRESCRIPTION D RUG USED TO TREAT AN ENROLLEE’S DIAGNOSIS 8
OF: 9
(1) BIPOLAR DISORDER; 10
(2) SCHIZOPHRENIA ; 11
(3) MAJOR DEPRESSION; 12
(4) POST–TRAUMATIC STRESS DIS ORDER; OR 13
(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 14
WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 15
SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 16
as follows: 17
Article – Insurance 18
15–142. 19
(a) (1) In this section the following words have the meanings indicated. 20
(2) “Step therapy drug” means a prescription drug or sequence of 21
prescription drugs required to be used under a step therapy or fail–first protocol. 22
(3) “Step therapy exception request” means a request to override a step 23
therapy or fail–first protocol. 24
(4) (i) “Step therapy or fail–first protocol” means a protocol established 25
by an insurer, a nonprofit health service plan, or a health maintenance organization that 26
requires a prescription drug or sequence of prescription drugs to be used by an insured or 27 SENATE BILL 990 3
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 1
is covered. 2
(ii) “Step therapy or fail–first protocol” includes a protocol that 3
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 4
or terminology used by the insurer, nonprofit health service plan, or health maintenance 5
organization to identify the protocol. 6
(5) “Supporting medical information” means: 7
(i) a paid claim from an entity subject to this section for an insured 8
or an enrollee; 9
(ii) a pharmacy record that documents that a prescription has been 10
filled and delivered to an insured or an enrollee, or a representative of an insured or an 11
enrollee; or 12
(iii) other information mutually agreed on by an entity subject to this 13
section and the prescriber of an insured or an enrollee. 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 provide 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
(c) An entity subject to this section may not impose a step therapy or fail–first 25
protocol on an insured or an enrollee if: 26
(1) the step therapy drug has not been approved by the U.S. Food and Drug 27
Administration for the medical condition being treated; or 28
(2) a prescriber provides supporting medical information to the entity that 29
a prescription drug covered by the entity: 30
(i) was ordered by a prescriber for the insured or enrollee within the 31
past 180 days; and 32
4 SENATE BILL 990
(ii) based on the professional judgment of the prescriber, was 1
effective in treating the insured’s or enrollee’s disease or medical condition. 2
(d) Subsection (c) of this section may not be construed to require coverage for a 3
prescription drug that is not: 4
(1) covered by the policy or contract of an entity subject to this section; or 5
(2) otherwise required by law to be covered. 6
(e) An entity subject to this section may not impose a step therapy or fail–first 7
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 8
Drug Administration if: 9
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 10
stage four advanced metastatic cancer; and 11
[(2)] (II) use of the prescription drug is: 12
[(i)] 1. consistent with the U.S. Food and Drug 13
Administration–approved indication or the National Comprehensive Cancer Network 14
Drugs & Biologics Compendium indication for the treatment of stage four advanced 15
metastatic cancer; and 16
[(ii)] 2. supported by peer–reviewed medical literature; OR 17
(2) THE PRESCRIPTION DRUG IS USED TO TREAT THE INSURED’S OR 18
ENROLLEE’S DIAGNOSIS OF: 19
(I) BIPOLAR DISORDER ; 20
(II) SCHIZOPHRENIA ; 21
(III) MAJOR DEPRESSION ; 22
(IV) POST–TRAUMATIC STRESS DIS ORDER; OR 23
(V) A MEDICATION –INDUCED MOVEMENT DIS ORDER 24
ASSOCIATED WITH THE TREATMENT OF A SERIO US MENTAL ILLNESS. 25
(f) (1) An entity subject to this section shall establish a process for requesting 26
an exception to a step therapy or fail–first protocol that is: 27
SENATE BILL 990 5
(i) clearly described, including the specific information and 1
documentation, if needed, that must be submitted by the prescriber to be considered a 2
complete step therapy exception request; 3
(ii) easily accessible to the prescriber; and 4
(iii) posted on the entity’s website. 5
(2) A step therapy exception request shall be granted if, based on the 6
professional judgment of the prescriber and any information and documentation required 7
under paragraph (1)(i) of this subsection: 8
(i) the step therapy drug is contraindicated or will likely cause an 9
adverse reaction to the insured or enrollee; 10
(ii) the step therapy drug is expected to be ineffective based on the 11
known clinical characteristics of the insured or enrollee and the known characteristics of 12
the prescription drug regimen; 13
(iii) the insured or enrollee is stable on a prescription drug prescribed 14
for the medical condition under consideration while covered under the policy or contract of 15
the entity or under a previous source of coverage; or 16
(iv) while covered under the policy or contract of the entity or a 17
previous source of coverage, the insured or enrollee has tried a prescription drug that: 18
1. is in the same pharmacologic class or has the same 19
mechanism of action as the step therapy drug; and 20
2. was discontinued by the prescriber due to lack of efficacy 21
or effectiveness, diminished effect, or an adverse event. 22
(3) On granting a step therapy exception request, an entity subject to this 23
section shall authorize coverage for the prescription drug ordered by the prescriber for an 24
insured or enrollee. 25
(4) An enrollee or insured may appeal a step therapy exception request 26
denial in accordance with Subtitle 10A or Subtitle 10B of this title. 27
(5) This subsection may not be construed to: 28
(i) prevent: 29
1. an entity subject to this section from requiring an insured 30
or enrollee to try an AB–rated generic equivalent or interchangeable biological product 31
before providing coverage for the equivalent branded prescription drug; or 32
6 SENATE BILL 990
2. a health care provider from prescribing a prescription 1
drug that is determined to be medically appropriate; or 2
(ii) require an entity subject to this section to provide coverage for a 3
prescription drug that is not covered by a policy or contract of the entity. 4
(6) An entity subject to this section may use an existing step therapy 5
exception process that satisfies the requirements under this subsection. 6
15–851.1. 7
(A) (1) THIS SECTION APPLIES TO: 8
(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 9
PROVIDE COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL, GROUP, OR 10
BLANKET HEALTH INSURANCE POL ICIES OR CONTRACTS T HAT ARE ISSUED OR 11
DELIVERED IN THE STATE; AND 12
(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 13
COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CONTRACTS 14
THAT ARE ISSUED OR D ELIVERED IN THE STATE. 15
(2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 16
MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 17
DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 18
REQUIREMENTS OF THIS SECTION. 19
(B) AN ENTITY SUBJECT TO THIS SECTION MAY NOT APPLY A PRIO R 20
AUTHORIZATION REQUIR EMENT FOR A PRESCRIP TION DRUG USED TO TREAT THE 21
INSURED’S OR ENROLLEE ’S DIAGNOSIS OF: 22
(1) BIPOLAR DISORDER ; 23
(2) SCHIZOPHRENIA ; 24
(3) MAJOR DEPRESSION ; 25
(4) POST–TRAUMATIC STRESS DIS ORDER; OR 26
(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 27
WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 28
SECTION 3. AND BE IT FURTHER ENACTED, That: 29
SENATE BILL 990 7
(a) On or before January 31, 2026, and each January 1 thereafter through 2030, 1
the Maryland Department of Health shall report to the Department of Legislative Services 2
on any cost increase to the Maryland Medical Assistance Program from the immediately 3
preceding fiscal year that results from the implementation of Section 1 of this Act. 4
(b) On or before April 30 of the year in which a report is submitted under 5
subsection (a) of this section, the Department of Legislative Services shall determine, based 6
on the report, whether the implementation of Section 1 of this Act resulted in a cost increase 7
to the Maryland Medical Assistance Program of more than $2,000,000 from the 8
immediately preceding fiscal year. 9
(c) If the Department of Legislative Services determines that the implementation 10
of Section 1 of this Act resulted in a cost increase to the Maryland Medical Assistance 11
Program of more than $2,000,000 from the immediately preceding fiscal year, with no 12
further action required by the General Assembly, at the end of April 30 of the year the 13
determination is made, Section 1 of this Act shall be abrogated and of no further force and 14
effect. 15
SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 16
apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the 17
State on or after January 1, 2025. 18
SECTION 5. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 19
effect January 1, 2025. 20
SECTION 6. AND BE IT FURTHER ENACTED, That, except as provided in Section 21
5 of this Act, this Act shall take effect July 1, 2024. 22