EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
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SENATE BILL 393
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By: Senator Lam
Introduced and read first time: January 17, 2025
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Health Insurance – Prescription Drug Formularies and Coverage for Generic 2
Drugs and Biosimilars 3
FOR the purpose of requiring certain carriers to post certain prescription drug formularies 4
and changes to the formularies in a certain manner on a carrier’s website; requiring 5
certain insurers, nonprofit health service plans, and health maintenance 6
organizations to make certain generic drugs and biosimilars available on a formulary 7
with certain cost sharing; and generally relating to prescription drug formularies, 8
generic drugs, and biosimilars. 9
BY adding to 10
Article – Insurance 11
Section 15–147 and 15–861 12
Annotated Code of Maryland 13
(2017 Replacement Volume and 2024 Supplement) 14
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 15
That the Laws of Maryland read as follows: 16
Article – Insurance 17
15–147. 18
(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 19
INDICATED. 20
(2) “CARRIER” MEANS: 21
(I) AN INSURER; 22
2 SENATE BILL 393
(II) A NONPROFIT HEALTH S ERVICE PLAN; 1
(III) A HEALTH MAINTENANCE ORGANIZA TION; 2
(IV) A DENTAL PLAN ORGANI ZATION; OR 3
(V) ANY OTHER PERSON THA T PROVIDES HEALTH BE NEFIT 4
PLANS SUBJECT TO REG ULATION BY THE STATE. 5
(3) “ENROLLEE” MEANS A PERSON ENTIT LED TO HEALTH CARE 6
BENEFITS FROM A CARR IER. 7
(4) “FORMULARY ” MEANS A LIST OF PRES CRIPTION DRUGS THAT IS 8
DEVELOPED BY A CARRI ER’S PHARMACY AND THERA PEUTICS COMMITTEE OR 9
OTHER CLINICAL AND P HARMACY EXPERTS AND REPRESENTS THE PRESCRIPTION 10
DRUGS APPROVED FOR C OVERAGE UNDER A HEALTH BENEFIT PLA N. 11
(B) EACH CARRIER SHALL POST ON ITS WEBSITE AN UPDATED, ACCURATE, 12
AND COMPLETE FORMULARY THAT IS EASILY ACCES SIBLE TO AN ENROLLEE, A 13
PROSPECTIVE ENROLLEE, THE STATE, AND THE PUBLIC . 14
(C) (1) A FORMULARY POSTED UNDER SUBSECT ION (B) OF THIS SECTION 15
SHALL: 16
(I) BE CLEARLY IDENTIFIED BY A LINK OR TAB ON THE 17
CARRIER’S WEBSITE; 18
(II) INCLUDE ANY TIERING STRUCT URE; AND 19
(III) INDICATE ANY RESTRIC TIONS ON THE MANNER IN WHICH A 20
DRUG MAY BE OBTAINED . 21
(2) A CARRIER MAY NOT REQU IRE AN INDIVIDUAL TO CREATE OR 22
ACCESS AN ACCOUNT OR ENTER A POLICY NUMBER ON T HE CARRIER’S WEBSITE TO 23
VIEW A FORMULARY POSTED UNDER SUBSECTION (B) OF THIS SECTION. 24
(D) IF A CARRIER OFFERS MOR E THAN ONE PRESCRIPT ION DRUG BENEFIT 25
PLAN, THE CARRIER ’S WEBSITE SHALL CLEARLY INDICA TE WHICH FORMULARY 26
APPLIES TO WHICH PLA N. 27
(E) IF A CARRIER MAKES A CHANGE TO A FORMULARY DURING A PLAN YEAR, 28
WITHIN 30 DAYS AFTER THE DATE THE C HANGE WAS MADE , THE CARRIER SHALL : 29
SENATE BILL 393 3
(1) UPDATE THE FORMULARY POSTED ON THE CARRIE R’S WEBSITE 1
UNDER SUBSECTION (B) OF THIS SECTION; AND 2
(2) CLEARLY AND IN BOLD TYPE INDICATE THE DATE THE CHANGE 3
WAS MADE AND A DESCRIPTION OF THE CHANGE ON THE CARRIER’S WEBSITE. 4
15–861. 5
(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANI NGS 6
INDICATED. 7
(2) “BIOSIMILAR” MEANS A BIOLOGICAL PRODUCT T HAT IS LICENSED 8
UNDER 42 U.S.C. § 262(K) AND HAS BEEN LISTED IN THE FDA’S DATABASE OF 9
LICENSED BIOLOGICAL PRODUCTS AS BIOSIMILA R TO OR INTERCHANGEA BLE WITH 10
A REFERENCE PRODUCT. 11
(3) “BRAND DRUG” MEANS A DRUG FOR WHI CH AN APPLICATION HA S 12
BEEN APPROVED UNDER 21 U.S.C. § 355(C) OR A BIOLOGICAL PROD UCT OTHER 13
THAN A BIOSIMILAR TH AT IS LICENSED UNDER 42 U.S.C. § 262(A). 14
(4) “FDA” MEANS THE FEDERAL FOOD AND DRUG ADMINISTRATION. 15
(5) “FORMULARY ” MEANS A LIST OF PRES CRIPTION DRUGS THAT IS 16
DEVELOPED BY A CARRIER’S PHARMACY AND THERAPE UTICS COMMITTEE OR 17
OTHER CLINICAL AND P HARMACY EXPERTS AND REPRESENTS THE PRESCRIPTION 18
DRUGS APPROVED FOR C OVERAGE UNDER A HEAL TH BENEFIT PLAN . 19
(6) “GENERIC DRUG ” MEANS A DRUG FOR WHI CH AN APPLICATION 20
HAS BEEN APPROVED UN DER 21 U.S.C. § 355(J) AND THAT HAS BEEN LISTED IN T HE 21
FDA’S APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE 22
EVALUATIONS AS THERAP EUTICALLY EQUIVALENT TO A REFERENCE LISTED DRUG, 23
INCLUDING A DRUG TO WHICH THE MANUFACTURER OF THE DRUG APPLIES A TRADE 24
NAME. 25
(7) “REFERENCE LISTED DRUG ” MEANS A PREVIOUSLY APPROVE D 26
DRUG IDENTIFIED BY T HE FDA AS THE DRUG PRODUCT TO WHICH A PROPOSED 27
GENERIC DRUG MUST BE COMPARED ON AN APPLICATION SUBMITTE D FOR 28
APPROVAL UNDER 21 U.S.C. § 355(J). 29
(8) “REFERENCE PRODUCT ” MEANS A SINGLE BIOLOGICAL PRODUCT 30
THAT IS LICENSED BY THE FDA UNDER 42 U.S.C. § 262(A) AGAINST WHICH A 31
PROPOSED BIOSIMILAR OR INTERCHANGEABLE P RODUCT IS COMPARED AND THAT 32 4 SENATE BILL 393
IS LISTED AS A REFERENC E PRODUCT IN THE FDA’S DATABASE OF LICENSED 1
BIOLOGICAL PRODUCTS. 2
(9) “WHOLESALE ACQUISITION COST” MEANS, WITH RESPECT TO A 3
DRUG OR BIOLOGICAL P RODUCT, THE MANUFACTURER ’S LIST PRICE FOR THE DRUG 4
OR THE BIOLOGICAL PR ODUCT TO WHOLESALERS OR DIREC T PURCHASERS IN THE 5
UNITED STATES, NOT INCLUDING PROMPT PAY OR OTHER DISCOUN TS, REBATES, OR 6
REDUCTIONS IN PRICE , FOR THE MOST RECENT MONTH FOR WHICH THE 7
INFORMATION IS AVAIL ABLE AS REPORTED IN WHOLE SALE PRICE GUIDES OR OTHER 8
PUBLICATION S OF DRUG OR BIOLOGI CAL PRODUCT PRICING DATA. 9
(B) (1) THIS SECTION APPLIES TO: 10
(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 11
PROVIDE COVERAGE FOR PRESCRIPTION DRUGS A ND DEVICES TO INDIVI DUALS OR 12
GROUPS UNDER HEALTH INSURANCE POLICIES O R CONTRA CTS THAT ARE 13
DELIVERED IN THE STATE; 14
(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 15
COVERAGE FOR PRESCRI PTION DRUGS AND DEVI CES TO INDIVIDUALS O R GROUPS 16
UNDER CONTRACTS THAT ARE ISSUED OR DELIVE RED IN THE STATE; AND 17
(III) INSURERS, NONPROFIT HE ALTH SERVICE PLAN S, OR 18
HEALTH MAINTENANCE O RGANIZATION S THAT PROVIDE COVERAG E FOR 19
PRESCRIPTION DRUGS A ND DEVICES THROUGH A PHARMACY BENEFITS MA NAGER. 20
(2) THIS SECTION DOES NOT APPLY TO A MANAGED C ARE 21
ORGANIZATION AS DEFI NED IN § 15–101 OF THE HEALTH – GENERAL ARTICLE. 22
(C) (1) EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS SUBSECTION , 23
AN ENTITY SUBJECT TO THIS SECTION THAT PR OVIDES COVERAGE FOR THE 24
REFERENCE LISTED DRU G FOR A GENERIC DRUG SHALL IMMEDIATELY MA KE THE 25
GENERIC DRUG AVAILAB LE ON A FORMULARY WI TH MORE FAVORABLE CO ST 26
SHARING THAN THE REFERENCE LISTED DRUG IF THE GENERIC DRU G: 27
(I) IS APPROVED BY THE FDA; 28
(II) IS MARKETED AS A GENERIC DRUG AP PROVED BY THE FDA; 29
AND 30
(III) HAS A WHOLESALE ACQUISITION COST THA T IS LESS THAN 31
THE WHOLESALE ACQUIS ITION COST OF THE RE FERENCE LISTED DRUG ON THE 32
INITIAL DATE OF MARK ETING FOR THE GENERIC DRUG . 33 SENATE BILL 393 5
(2) AN ENTITY SUBJECT TO THIS SECTION MAY NOT IMPOSE: 1
(I) A PRIOR AUTHORIZATIO N OR STEP THERAPY REQUIREMENT 2
OR OTHER LIMITATION ON THE COVERAGE FOR A GENER IC DRUG ADDED TO A 3
FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION ; OR 4
(II) A RESTRICTION ON A P HARMACY THAT MAKES I T MORE 5
DIFFICULT FOR AN ENROLLEE TO OBTAIN COVERAGE FOR OR ACCE SS TO A GENERIC 6
DRUG ADDED TO A FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION THAN 7
IT IS FOR THE ENROLL EE TO OBTAIN COVERAG E FOR OR ACCESS TO THE REFERENCE 8
LISTED DRUG. 9
(3) THIS SUBSECTION DOES NOT APPLY IF THE WHOLESALE 10
ACQUISITION COST OF THE GENERIC DRUG BECOMES GREATER THAN THE 11
WHOLESALE ACQUISITIO N COST OF THE REFERE NCE LISTED DRUG . 12
(D) (1) EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS SUBSECTION , 13
AN ENTITY SUBJECT TO THIS SECTION THAT PROVIDES COVERA GE FOR A 14
REFERENCE PRODUCT FOR A BIOSIMILAR SHALL IMMEDIATELY MAKE AT LEAST ONE 15
BIOSIMILAR FOR THE REFERENCE PRODUCT AVAILABLE ON THE ENTITY’S 16
FORMULARY WITH MORE FAVORABLE COST SHARING THAN THE REFERENCE 17
PRODUCT IF THE BIOSIMILAR : 18
(I) IS LICENSED BY THE FDA; 19
(II) IS MARKETED AS A BIOSIMILAR LICENSED BY THE FDA; AND 20
(III) HAS A WHOLESALE ACQU ISITION COST THAT IS LESS THAN 21
THE WHOLESALE ACQUIS ITION COST OF THE RE FERENCE PRODUCT ON THE INITIAL 22
DATE OF MARKETING FOR THE BIOSIMILAR . 23
(2) AN ENTITY SUBJECT TO THIS SECTION MAY NOT IMPOSE: 24
(I) A PRIOR AUTHORIZATIO N OR STEP THERAPY RE QUIREMENT 25
OR OTHER LIMITATION ON THE COVERAGE FOR A BIOSI MILAR ADDED TO A 26
FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION ; OR 27
(II) A RESTRICTION ON A P HARMACY THAT MAKES I T MORE 28
DIFFICULT FOR AN ENROLLEE TO OBTAIN COVERAGE F OR OR ACCESS TO A 29
BIOSIMILAR ADDED TO A FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION 30
THAN IT IS FOR THE ENROLL EE TO OBTAIN COVERAG E FOR OR ACCESS TO THE 31
REFERENCE PRODUCT . 32 6 SENATE BILL 393
(3) THIS SUBSECTION DOES NOT APPLY IF THE WHOLESALE 1
ACQUISITION COST OF THE BIOSIMILAR BECOMES GREATER THAN THE WHOLESALE 2
ACQUISITION COST OF THE REFERENCE PRODUC T. 3
(E) IF A GENERIC DRUG IS ADDED TO A FORMUL ARY UNDER SUBSECTION (C) 4
OF THIS SECTION OR A BIOSIMILAR IS ADDED TO A FORMULARY UNDER SUBSECTION 5
(D) OF THIS SECTION , AN ENTITY SUBJECT TO THIS SECTION SHALL I NFORM 6
ENROLLEES OF THE CHA NGE IN FORMULARY IN ACCORDANCE WITH § 15–147 OF 7
THIS TITLE. 8
(F) THIS SECTION DOES NOT REQUIRE A N ENTITY SUBJECT TO THIS 9
SECTION TO PROVIDE C OVERAGE FOR A BRAND DRUG AFTER A GENERIC DRUG IS 10
APPROVED BY THE FDA OR A BIOSIMILAR IS LICENSED BY THE FDA AND 11
MARKETED, AS APPLICABLE. 12
(G) THIS SECTION DOES NOT REQUIRE A N ENTITY SUBJECT TO THIS 13
SECTION TO PROVIDE C OVERAGE FOR A BRAND DRUG, GENERIC DRUG , OR 14
BIOSIMILAR IF THE PHARMACY AND THERAPE UTICS COMMITTEE OR O THER 15
CLINICAL AND PHARMAC Y EXPERTS THAT DEVEL OP THE ENTITY’S FORMULARY 16
DETERMINE THAT THE B RAND DRUG, GENERIC DRUG , OR BIOSIMILAR IS NO LONGER 17
MEDICALLY APPROPRIAT E OR COST–EFFECTIVE. 18
(H) THIS SECTION MAY NOT BE CONSTRUED TO INTERFERE WITH A 19
PHARMACIST COMPLYING WITH THE MARYLAND PHARMACY ACT. 20
(I) THE COMMISSIONER MAY ADOPT REGULATION S TO CARRY OUT THIS 21
SECTION. 22
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 23
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 24
after January 1, 2026. 25
SECTION 3. AND BE IT FURTHER ENACTED, T hat this Act shall take effect 26
January 1, 2026. 27