EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb0382*
HOUSE BILL 382
J5, J4, J1 5lr2479
CF SB 111
By: Delegates S. Johnson, A. Johnson, Kerr, McComas, and Taveras
Introduced and read first time: January 16, 2025
Assigned to: Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
Maryland Medical Assistance Program and Health Insurance – Step Therapy, 2
Fail–First Protocols, and Prior Authorization – Prescription to Treat Serious 3
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 of certain insureds and enrollees; and generally relating to coverage 9
of prescription drugs to treat serious mental illness. 10
BY adding to 11
Article – Health – General 12
Section 15–102.3(m) and 15–157 13
Annotated Code of Maryland 14
(2023 Replacement Volume and 2024 Supplement) 15
BY repealing and reenacting, with amendments, 16
Article – Insurance 17
Section 15–142 18
Annotated Code of Maryland 19
(2017 Replacement Volume and 2024 Supplement) 20
BY adding to 21
Article – Insurance 22
Section 15–851.1 23
Annotated Code of Maryland 24
(2017 Replacement Volume and 2024 Supplement) 25
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 26
That the Laws of Maryland read as follows: 27 2 HOUSE BILL 382
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
15–157. 5
(A) IN THIS SECTION, “STEP THERAPY OR FAIL –FIRST PROTOCOL ” HAS THE 6
MEANING STATED IN § 15–142 OF THE INSURANCE ARTICLE. 7
(B) EXCEPT AS REQUIRED UN DER 42 U.S.C. § 1396A, BEGINNING JULY 1, 8
2025, THE PROGRAM MAY NOT APPLY A PRIOR AUTHORIZATIO N REQUIREMENT FOR 9
A PRESCRIPTION DRUG USED TO TREAT AN ADU LT ENROLLEE’S DIAGNOSIS OF: 10
(1) BIPOLAR DISORDER ; 11
(2) SCHIZOPHRENIA ; 12
(3) MAJOR DEPRESSION ; 13
(4) POST–TRAUMATIC STRESS DIS ORDER; OR 14
(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 15
WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 16
(C) BEGINNING JULY 1, 2025, THE PROGRAM MAY NOT APPLY A STEP 17
THERAPY OR FAIL –FIRST PROTOCOL FOR A PRESCRIPTION DRUG US ED TO TREAT AN 18
ENROLLEE’S DIAGNOSIS OF: 19
(1) BIPOLAR DISORDER ; 20
(2) SCHIZOPHRENIA ; 21
(3) MAJOR DEPRESSION ; 22
(4) POST–TRAUMATIC STRESS DIS ORDER; OR 23
(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 24
WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 25
HOUSE BILL 382 3
SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 1
as follows: 2
Article – Insurance 3
15–142. 4
(a) (1) In this section the following words have the meanings indicated. 5
(2) “Step therapy drug” means a prescription drug or sequence of 6
prescription drugs required to be used under a step therapy or fail–first protocol. 7
(3) “Step therapy exception request” means a request to override a step 8
therapy or fail–first protocol. 9
(4) (i) “Step therapy or fail–first protocol” means a protocol established 10
by an insurer, a nonprofit health service plan, or a health maintenance organization that 11
requires a prescription drug or sequence of prescription drugs to be used by an insured or 12
an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 13
is covered. 14
(ii) “Step therapy or fail–first protocol” includes a protocol that 15
meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 16
or terminology used by the insurer, nonprofit health service plan, or health maintenance 17
organization to identify the protocol. 18
(5) “Supporting medical information” means: 19
(i) a paid claim from an entity subject to this section for an insured 20
or an enrollee; 21
(ii) a pharmacy record that documents that a prescription has been 22
filled and delivered to an insured or an enrollee, or a representative of an insured or an 23
enrollee; or 24
(iii) other information mutually agreed on by an entity subject to this 25
section and the prescriber of an insured or an enrollee. 26
(b) (1) This section applies to: 27
(i) insurers and nonprofit health service plans that provide hospital, 28
medical, or surgical benefits to individuals or groups on an expense–incurred basis under 29
health insurance policies or contracts that are issued or delivered in the State; and 30
(ii) health maintenance organizations that provide hospital, 31
medical, or surgical benefits to individuals or groups under contracts that are issued or 32
delivered in the State. 33 4 HOUSE BILL 382
(2) An insurer, a nonprofit health service plan, or a health maintenance 1
organization that provides coverage for prescription drugs through a pharmacy benefits 2
manager is subject to the requirements of this section. 3
(c) An entity subject to this section may not impose a step therapy or fail–first 4
protocol on an insured or an enrollee if: 5
(1) the step therapy drug has not been approved by the U.S. Food and Drug 6
Administration for the medical condition being treated; or 7
(2) a prescriber provides supporting medical information to the entity that 8
a prescription drug covered by the entity: 9
(i) was ordered by a prescriber for the insured or enrollee within the 10
past 180 days; and 11
(ii) based on the professional judgment of the prescriber, was 12
effective in treating the insured’s or enrollee’s disease or medical condition. 13
(d) Subsection (c) of this section may not be construed to require coverage for a 14
prescription drug that is not: 15
(1) covered by the policy or contract of an entity subject to this section; or 16
(2) otherwise required by law to be covered. 17
(e) An entity subject to this section may not impose a step therapy or fail–first 18
protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 19
Drug Administration if: 20
(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 21
stage four advanced metastatic cancer; and 22
[(2)] (II) use of the prescription drug is: 23
[(i)] 1. consistent with the U.S. Food and Drug 24
Administration–approved indication or the National Comprehensive Cancer Network 25
Drugs & Biologics Compendium indication for the treatment of stage four advanced 26
metastatic cancer; and 27
[(ii)] 2. supported by peer–reviewed medical literature; OR 28
(2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR 29
ENROLLEE’S DIAGNOSIS OF: 30
HOUSE BILL 382 5
(I) BIPOLAR DISORDER ; 1
(II) SCHIZOPHRENIA ; 2
(III) MAJOR DEPRESSION ; 3
(IV) POST–TRAUMATIC STRESS DIS ORDER; OR 4
(V) A MEDI CATION–INDUCED MOVEMENT DIS ORDER 5
ASSOCIATED WITH THE TREATMENT OF A SERIO US MENTAL ILLNESS . 6
(f) (1) An entity subject to this section shall establish a process for requesting 7
an exception to a step therapy or fail–first protocol that is: 8
(i) clearly described, including the specific information and 9
documentation, if needed, that must be submitted by the prescriber to be considered a 10
complete step therapy exception request; 11
(ii) easily accessible to the prescriber; and 12
(iii) posted on the entity’s website. 13
(2) A step therapy exception request shall be granted if, based on the 14
professional judgment of the prescriber and any information and documentation required 15
under paragraph (1)(i) of this subsection: 16
(i) the step therapy drug is contraindicated or will likely cause an 17
adverse reaction to the insured or enrollee; 18
(ii) the step therapy drug is expected to be ineffective based on the 19
known clinical characteristics of the insured or enrollee and the known characteristics of 20
the prescription drug regimen; 21
(iii) the insured or enrollee is stable on a prescription drug prescribed 22
for the medical condition under consideration while covered under the policy or contract of 23
the entity or under a previous source of coverage; or 24
(iv) while covered under the policy or contract of the entity or a 25
previous source of coverage, the insured or enrollee has tried a prescription drug that: 26
1. is in the same pharmacologic class or has the same 27
mechanism of action as the step therapy drug; and 28
2. was discontinued by the prescriber due to lack of efficacy 29
or effectiveness, diminished effect, or an adverse event. 30
6 HOUSE BILL 382
(3) On granting a step therapy exception request, an entity subject to this 1
section shall authorize coverage for the prescription drug ordered by the prescriber for an 2
insured or enrollee. 3
(4) An enrollee or insured may appeal a step therapy exception request 4
denial in accordance with Subtitle 10A or Subtitle 10B of this title. 5
(5) This subsection may not be construed to: 6
(i) prevent: 7
1. an entity subject to this section from requiring an insured 8
or enrollee to try an AB–rated generic equivalent or interchangeable biological product 9
before providing coverage for the equivalent branded prescription drug; or 10
2. a health care provider from prescribing a prescription 11
drug that is determined to be medically appropriate; or 12
(ii) require an entity subject to this section to provide coverage for a 13
prescription drug that is not covered by a policy or contract of the entity. 14
(6) An entity subject to this section may use an existing step therapy 15
exception process that satisfies the requirements under this subsection. 16
15–851.1. 17
(A) (1) THIS SECTION APPLIES TO: 18
(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 19
PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 20
BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 21
DELIVERED IN THE STATE; AND 22
(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 23
COVERAGE FOR PRESCRI PTION DRUGS U NDER INDIVIDUAL OR G ROUP CONTRACTS 24
THAT ARE ISSUED OR D ELIVERED IN THE STATE. 25
(2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 26
MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 27
DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJ ECT TO THE 28
REQUIREMENTS OF THIS SECTION. 29
(B) EXCEPT AS REQUIRED UN DER 42 U.S.C. § 1396A, AN ENTITY SUBJECT 30
TO THIS SECTION MAY NOT APPLY A PRIOR AU THORIZATION REQUIREM ENT FOR A 31 HOUSE BILL 382 7
PRESCRIPTION DRUG US ED TO TREAT AN ADULT INSURED’S OR ENROLLEE ’S 1
DIAGNOSIS OF: 2
(1) BIPOLAR DISORDER ; 3
(2) SCHIZOPHRENIA ; 4
(3) MAJOR DEPRESSION ; 5
(4) POST–TRAUMATIC STRESS DIS ORDER; OR 6
(5) A MEDICATION –INDUCED MOVEMENT DIS ORDER ASSOCIATED 7
WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 8
SECTION 3. AND BE IT FURTHER ENAC TED, That: 9
(a) On or before January 31, 2027, and each January 1 thereafter through 2031, 10
the Maryland Department of Health shall report to the Department of Legislative Services 11
on any cost increase to the Maryland Medical Assistance Program from the immediately 12
preceding fiscal year that results from the implementation of Section 1 of this Act. 13
(b) On or before April 30 of the year in which a report is submitted under 14
subsection (a) of this section, the Department of Legislative Services shall determine, based 15
on the report, whether the implementation of Section 1 of this Act resulted in a cost increase 16
to the Maryland Medical Assistance Program of more than $2,000,000 from the 17
immediately preceding fiscal year. 18
(c) If the Department of Legislative Services determines that the implementation 19
of Section 1 of this Act resulted in a cost increase to the Maryland Medical Assistance 20
Program of more than $2,000,000 from the immediately preceding fiscal year, with no 21
further action required by the General Assembly, at the end of April 30 of the year the 22
determination is made, Section 1 of this Act shall be abrogated and of no further force and 23
effect. 24
SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 25
apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the 26
State on or after January 1, 2026. 27
SECTION 5. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 28
effect January 1, 2026. 29
SECTION 6. AND BE IT FURTHER ENACTED, That, except as provided in Section 30
5 of this Act, this Act shall take effect July 1, 2025. 31