Maryland 2025 2025 Regular Session

Maryland Senate Bill SB357 Engrossed / Bill

Filed 03/12/2025

                     
 
EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. 
        [Brackets] indicate matter deleted from existing law. 
         Underlining indicates amendments to bill. 
         Strike out indicates matter stricken from the bill by amendment or deleted from the law by 
amendment. 
          *sb0357*  
  
SENATE BILL 357 
J1, J5   	5lr2092 
    	CF HB 424 
By: Senators Gile and Feldman, Feldman, and Hester 
Introduced and read first time: January 16, 2025 
Assigned to: Finance 
Committee Report: Favorable with amendments 
Senate action: Adopted 
Read second time: February 22, 2025 
 
CHAPTER ______ 
 
AN ACT concerning 1 
 
Prescription Drug Affordability Board – Authority for Upper Payment Limits 2 
and Stakeholder Council Membership 3 
(Lowering Prescription Drug Costs for All Marylanders Now Act) 4 
 
FOR the purpose of altering the membership of the Prescription Drug Affordability 5 
Stakeholder Council; requiring the Prescription Drug Affordability Board, under 6 
certain circumstances, to establish a process for setting upper payment limits for all 7 
purchases and payor reimbursements of prescription drug products in the State that 8 
the Board determines have led or will lead to affordability challenges; authorizing 9 
the Board to reconsider an upper payment limit for a drug that becomes a current 10 
shortage; altering requirements related to the setting of upper payment limits by the 11 
Board; requiring the Board to confer with the Maryland Medical Assistance Program 12 
before establishing an upper payment limit that applies to the Program; prohibiting 13 
the Board from taking certain actions related to upper payment limits; and generally 14 
relating to the Prescription Drug Affordability Board.  15 
 
BY repealing and reenacting, with amendments, 16 
 Article – Health – General 17 
Section 21–2C–01, 21–2C–04, 21–2C–13, and 21–2C–14 18 
 Annotated Code of Maryland 19 
 (2023 Replacement Volume and 2024 Supplement) 20 
 
BY repealing and reenacting, without amendments, 21 
 Article – Health – General 22 
Section 21–2C–09(c) and 21–2C–11(a) 23  2 	SENATE BILL 357  
 
 
 Annotated Code of Maryland 1 
 (2023 Replacement Volume and 2024 Supplement) 2 
 
BY adding to 3 
 Article – Health – General 4 
 Section 21–2C–09(d) and (e) and 21–2C–16 5 
 Annotated Code of Maryland 6 
 (2023 Replacement Volume and 2024 Supplement)  7 
 
BY repealing 8 
 Article – Health – General 9 
Section 21–2C–11(d) and 21–2C–16 10 
 Annotated Code of Maryland 11 
 (2023 Replacement Volume and 2024 Supplement) 12 
 
BY adding to 13 
 Article – Health – General 14 
Section 21–2C–16 15 
 Annotated Code of Maryland 16 
 (2023 Replacement Volume and 2024 Supplement) 17 
 
 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 18 
That the Laws of Maryland read as follows: 19 
 
Article – Health – General 20 
 
21–2C–01. 21 
 
 (a) In this subtitle the following words have the meanings indicated. 22 
 
 (b) “Biologic” means a drug that is produced or distributed in accordance with a 23 
biologics license application approved under 42 C.F.R. § 447.502. 24 
 
 (c) “Biosimilar” means a drug that is produced or distributed in accordance with 25 
a biologics license application approved under 42 U.S.C. § 262(k)(3). 26 
 
 (d) “Board” means the Prescription Drug Affordability Board. 27 
 
 (e) (1) “Brand name drug” means a drug that is produced or distributed in 28 
accordance with an original new drug application approved under 21 U.S.C. § 355(c). 29 
 
 (2) “Brand name drug” does not include an authorized generic as defined 30 
by 42 C.F.R. § 447.502. 31 
 
 (F) “CURRENT SHORTAGE ” MEANS A DRUG : 32 
   	SENATE BILL 357 	3 
 
 
 (1) LISTED AS CURRENT ON THE FEDERAL FOOD AND DRUG 1 
ADMINISTRATION ’S DRUG SHORTAGE DATABASE; OR 2 
 
 (2) OTHERWISE DETERMINED BY THE BOARD TO BE IN SHORT 3 
SUPPLY IN THE STATE. 4 
 
 [(f)] (G) “Generic drug” means: 5 
 
 (1) A retail drug that is marketed or distributed in accordance with an 6 
abbreviated new drug application, approved under 21 U.S.C. § 355(j); 7 
 
 (2) An authorized generic as defined by 42 C.F.R. § 447.502; or 8 
 
 (3) A drug that entered the market before 1962 that was not originally 9 
marketed under a new drug application. 10 
 
 [(g)] (H) “Manufacturer” means an entity that: 11 
 
 (1) (i) Engages in the manufacture of a prescription drug product; or 12 
 
 (ii) Enters into a lease with another manufacturer to market and 13 
distribute a prescription drug product under the entity’s own name; and 14 
 
 (2) Sets or changes the wholesale acquisition cost of the prescription drug 15 
product it manufactures or markets. 16 
 
 [(h)] (I) “Prescription drug product” means a brand name drug, a generic drug, 17 
a biologic, or a biosimilar. 18 
 
 [(i)] (J) “Stakeholder Council” means the Prescription Drug Affordability 19 
Stakeholder Council. 20 
 
21–2C–04. 21 
 
 (a) There is a Prescription Drug Affordability Stakeholder Council. 22 
 
 (b) The purpose of the Stakeholder Council is to provide stakeholder input to 23 
assist the Board in making decisions as required under this subtitle. 24 
 
 (c) (1) The Stakeholder Council consists of [26] members appointed in 25 
accordance with this subsection. 26 
 
 (2) The Speaker of the House of Delegates shall appoint: 27 
 
 (i) One representative of generic drug corporations; 28 
  4 	SENATE BILL 357  
 
 
 (ii) One representative of nonprofit insurance carriers; 1 
 
 (iii) One representative of a statewide health care advocacy coalition; 2 
 
 (iv) One representative of a statewide advocacy organization for 3 
seniors; 4 
 
 (v) One representative of a statewide organization for diverse 5 
communities; 6 
 
 (vi) One representative of a labor union; 7 
 
 (vii) ONE REPRESENTATIVE OF THE RARE DISEASE COM MUNITY; 8 
 
 (VIII) One health services researcher specializing in prescription 9 
drugs; and 10 
 
 [(viii)] (IX) One public member at the discretion of the Speaker of the 11 
House of Delegates. 12 
 
 (3) The President of the Senate shall appoint: 13 
 
 (i) One representative of brand name drug corporations; 14 
 
 (ii) One representative of physicians; 15 
 
 (iii) One representative of nurses; 16 
 
 (iv) One representative of hospitals; 17 
 
 (v) One representative of dentists; 18 
 
 (vi) ONE REPRESENTATIVE OF ONCOLOGISTS ; 19 
 
 (VII) One representative of managed care organizations; 20 
 
 [(vii)] (VIII) One representative of the Department of Budget and 21 
Management; 22 
 
 [(viii)] (IX) One clinical researcher; and 23 
 
 [(ix)] (X) One public member at the discretion of the President of 24 
the Senate. 25 
 
 (4) The Governor shall appoint: 26 
   	SENATE BILL 357 	5 
 
 
 (i) One representative of brand name drug corporations; 1 
 
 (ii) One representative of generic drug corporations; 2 
 
 (iii) One representative of biotechnology companies; 3 
 
 (iv) One representative of for–profit health insurance carriers; 4 
 
 (v) One representative of employers; 5 
 
 (vi) One representative of pharmacy benefits managers; 6 
 
 (vii) One representative of pharmacists; 7 
 
 (viii) One pharmacologist; [and] 8 
 
 (ix) ONE REPRESENTATIVE OF A PATIENT ADVOCACY 9 
ORGANIZATION ; AND 10 
 
 (X) One public member at the discretion of the Governor. 11 
 
 (5) Collectively, the members of the Stakeholder Council shall have 12 
knowledge of the following: 13 
 
 (i) The pharmaceutical business model; 14 
 
 (ii) Supply chain business models; 15 
 
 (iii) The practice of medicine or clinical training; 16 
 
 (iv) Consumer or patient perspectives; 17 
 
 (v) Health care costs trends and drivers; 18 
 
 (vi) Clinical and health services research; or 19 
 
 (vii) The State’s health care marketplace. 20 
 
 (6) To the extent practicable and consistent with federal and State law, the 21 
membership of the Stakeholder Council shall reflect the racial, ethnic, and gender diversity 22 
of the State. 23 
 
 (7) From among the membership of the Stakeholder Council, the Board 24 
chair shall appoint two members to be cochairs of the Stakeholder Council. 25 
 
 (d) (1) The term of a member is 3 years. 26 
  6 	SENATE BILL 357  
 
 
 (2) The initial members of the Stakeholder Council shall serve staggered 1 
terms as required by the terms provided for members on October 1, 2019. 2 
 
 (e) A member of the Stakeholder Council: 3 
 
 (1) May not receive compensation as a member of the Stakeholder Council; 4 
but 5 
 
 (2) Is entitled to reimbursement for expenses under the Standard State 6 
Travel Regulations, as provided in the State budget. 7 
 
21–2C–09.  8 
 
 (c) On or before December 31, 2020, and each December 31 thereafter, the Board 9 
shall submit to the Senate Finance Committee and the House Health and Government 10 
Operations Committee, in accordance with § 2–1257 of the State Government Article, a 11 
report that includes: 12 
 
 (1) Price trends for prescription drug products; 13 
 
 (2) The number of prescription drug products that were subject to Board 14 
review and the results of the review; and 15 
 
 (3) Any recommendations the Board may have on further legislation 16 
needed to make prescription drug products more affordable in the State. 17 
 
 (D) IF THE BOARD SETS A NEW UPPE R PAYMENT LIMIT , THE BOARD SHALL 18 
INCLUDE IN THE FIRST REPORT THAT IS REQUI RED UNDER SUBSECTION (C) OF THIS 19 
SECTION AFTER THE UP PER PAYMENT LIMIT HA S BEEN IN EFFECT FOR 1 YEAR 20 
INFORMATION ON THE E FFECTS OF THE UPPER PAYMENT LIM IT, BASED ON 21 
AVAILABLE TIMELY DAT A, FOR THE FOLLOWING : 22 
 
 (1) PATIENT OUT–OF–POCKET COSTS INCLUDI NG WHETHER THE 23 
UPPER PAYMENT LIMIT WAS ASSOCIATED WITH INCREASES OR DECREAS ES IN WHAT 24 
PATIENTS PAY FOR PRE SCRIPTION DRUG PRODU CTS; 25 
 
 (2) PATIENT HEALTH INSURA NCE PREMIUMS , INCLUDING WHETHER 26 
THE UPPER PAYMENT LI MIT IS ASSOCIATED WI TH INCREASES OR DECR EASES IN 27 
HEALTH INSURANCE COS TS FOR PATIENTS; 28 
 
 (3) PHARMACIES OPERATING IN THE STATE, INCLUDING THE IMPACT 29 
ON REIMBURSEMENT RAT ES AND FINANCIAL VIA BILITY OF RETAI L AND 30 
INDEPENDENT PHARMACI ES; 31 
   	SENATE BILL 357 	7 
 
 
 (4) PATIENT HEALTH INSURA NCE FORMULARIES , INCLUDING 1 
WHETHER THE PRESCRIP TION DRUG PRODUCT SU BJECT TO THE UPPER P AYMENT 2 
LIMIT REMAINED ON FO RMULARIES; 3 
 
 (5) PROVIDER–ADMINISTERED MEDICAT IONS SUBJECT TO THE 4 
UPPER PAYMENT LIMIT, INCLUDING WHETHER PR OVIDERS WERE ABLE TO ACQUIRE 5 
THE PRESCRIPTION DRU G PRODUCT SUBJECT TO THE UPPER PAYMENT LI MIT AT A 6 
RATE TO ACCOUNT FOR ACQUISITION COSTS AN D WHETHER THERE WAS AN IMPACT 7 
ON PROVIDER REIMBURS EMENT; 8 
 
 (6) PATIENT ACCESS TO THE PRESCRIPTION DRUG PRODUC T 9 
SUBJECT TO THE UPPER PAYMENT LIMIT , WHICH MAY INCLUDE : 10 
 
 (I) WHETHER PRESCRIPTION DRUG PRODUCT SHORTAG ES OR 11 
OTHER SUPPLY DISRUPT IONS OCCURRED AFTER THE UPPER PAYMENT LI MIT TOOK 12 
EFFECT; 13 
 
 (II) WHETHER FORMULARY PLA CEMENT OR PLAN DESIGN 14 
CHANGES MADE THE PRE SCRIPTION DRUG PRODU CT SUBJECT TO THE UP PER LIMIT 15 
MORE DIFFICULT FOR P ATIENTS TO ACCESS , INCLUDING IF INSURAN CE PLANS 16 
PREFERRED A PRESCRIP TION DRUG PRODUCT WI THOUT AN UPPER PAYME NT LIMIT 17 
OVER A PRESCRIPTION DRUG PRODUCT SUBJECT TO AN UPPER PAYMENT L IMIT; 18 
 
 (III) WHETHER THE DISTRIBUT ION AND DELIVERY OF 19 
SPECIALTY OR RARE DI SEASE MEDICATIONS FR OM OUT–OF–STATE PHARMACIES TO 20 
PROVIDERS, PHARMACIES , OR PATIENTS WAS IMPA CTED; 21 
 
 (IV) WHETHER PATIENTS IN C OMMUNITIES OF COLOR , 22 
PATIENTS WHO ARE WOMEN , PATIENTS WITH A RARE DISEASE, OR PATIENTS IN 23 
RURAL AREAS EXPERIEN CED DISPROPORTIONATE ACCESS CHALLENGES ; AND 24 
 
 (V) WHETHER COST DIFFEREN CES AS A RESULT OF T HE UPPER 25 
PAYMENT LIMIT AFFECT ED PATIENTS, PHARMACIES , OR PROVIDERS AND , IF THE 26 
COST DIFFERENCE RESULTED IN AN INCREASE IN CO STS, WHO WAS ULTIMATELY 27 
RESPONSIBLE FOR BEAR ING THE INCREASED CO ST; 28 
 
 (7) COVERED ENTITY PROVID ERS PARTICIPATING IN THE 340B DRUG 29 
DISCOUNT PROGRAM , INCLUDING THE IMPACT OF THE UPPER PAYMENT LIMIT ON 30 
THE OPERATIONS OF THE PROVIDERS AND THEIR CONTRACTED PHA RMACIES; AND 31 
 
 (8) THE BIOTECHNOLOGY IND USTRY IN THE STATE, INCLUDING THE 32 
IMPACT ON PHARMACEUT ICAL RESEARCH AND DE VELOPMENT , INVESTMENT, AND 33 
JOB GROWTH . 34 
  8 	SENATE BILL 357  
 
 
 (E) (1) THE BOARD MAY REQUEST INF ORMATION NECESSARY T O 1 
COMPLETE THE REPORT REQU IRED UNDER SUBSECTIO NS (C) AND (D) OF THIS 2 
SECTION FROM AN AFFE CTED ENTITY. 3 
 
 (2) THE ENTITY FROM WHICH INFORMATION WAS REQU ESTED UNDER 4 
PARAGRAPH (1) OF THIS SUBSECTION S HALL MAKE A GOOD FAI TH EFFORT TO 5 
PROVIDE THE REQUESTE D INFORMATIO N.  6 
 
21–2C–11. 7 
 
 (a) In this section, “Fund” means the Prescription Drug Affordability Fund. 8 
 
 [(d) (1) The Board shall be established using special or general funds, which 9 
shall be repaid to the State with the funds from the Fund. 10 
 
 (2) If the Board receives funding from the Maryland Health Care 11 
Commission under paragraph (1) of this subsection, the Board shall repay the funds to the 12 
Commission from the Fund over a 3–year period beginning June 1, 2021.] 13 
 
21–2C–13. 14 
 
 (a) If, under § 21–2C–07 of this subtitle, the Board finds that it is in the best 15 
interest of the State to establish a process for setting upper payment limits for prescription 16 
drug products that it determines have led or will lead to an affordability challenge, the 17 
Board, in conjunction with the Stakeholder Council, shall draft a plan of action for 18 
implementing the process [that includes the criteria the Board shall use to set upper 19 
payment limits] IN ACCORDANCE WITH T HE REQUIREMENTS OF T HIS SECTION. 20 
 
 (b) The criteria for setting upper payment limits shall include consideration of: 21 
 
 (1) The cost of administering the prescription drug product; 22 
 
 (2) The cost of delivering the prescription drug product to consumers; [and] 23 
 
 (3) THE EFFECT THE UPPER PAYMENT LIMIT WILL H AVE ON 24 
PROVIDERS OF 340B DRUGS; 25 
 
 (4) FOR AN UPPER PAYMENT LIMIT ON A DRUG THAT IS DESIGNATED 26 
AS A DRUG FOR A RARE DISEASE OR CONDITION , THE IMPACT OF THE UP PER 27 
PAYMENT LIMIT ON PAT IENTS WITH RARE DISE ASES; AND 28 
 
 [(3)] (4) (5) Other relevant administrative costs related to the prescription 29 
drug product. 30 
 
 [(c) The process for setting upper payment limits shall: 31   	SENATE BILL 357 	9 
 
 
 
 (1) Prohibit the application of an upper payment limit for a prescription 1 
drug product that is on the federal Food and Drug Administration prescription drug 2 
shortage list; and 3 
 
 (2) Require the Board to: 4 
 
 (i) Monitor the availability of any prescription drug product for 5 
which it sets an upper payment limit; and 6 
 
 (ii) If there becomes a shortage of the prescription drug product in 7 
the State, reconsider or suspend the upper payment limit.] 8 
 
 (C) (1) IF THE BOARD PREVIOUSLY SET AN UPPER PAYMENT LIM IT FOR A 9 
DRUG THAT BECOMES A CURRENT SHORTAGE , THE BOARD MAY RECONSIDER THE 10 
PREVIOUSLY SET UPPER PAYMENT LIMIT . 11 
 
 (2) THE BOARD MAY NOT : 12 
 
 (I) ESTABLISH A NEW UP PER PAYMENT LIMIT FO R A CURRENT 13 
SHORTAGE;  14 
 
 (II) ENFORCE AN UPPER PAYM ENT LIMIT AGAINST PR OVIDER 15 
OR PHARMACY REIMBURS EMENT REQUIREMENTS F OR MEDICARE PART C OR PART 16 
D PLANS; OR 17 
 
 (III) COUNT A PHARMACY DISP ENSING FEE TOWARD OR 18 
SUBJECT A PHARMACY DISPENSING FEE TO AN UPPER PAYMENT LIMIT . 19 
 
 (d) (1) If a plan of action is drafted under subsection (a) of this section, the 20 
Board shall submit the plan of action to the Legislative Policy Committee of the General 21 
Assembly, in accordance with § 2–1257 of the State Government Article, for its approval. 22 
 
 (2) The Legislative Policy Committee shall have 45 days to approve the 23 
plan of action. 24 
 
 (3) If the Legislative Policy Committee does not approve the plan of action, 25 
the Board shall submit the plan to the Governor and the Attorney General for approval. 26 
 
 (4) The Governor and the Attorney General shall have 45 days to approve 27 
the plan of action. 28 
 
 (5) The Board may not set upper payment limits unless the plan is 29 
approved, in accordance with this subsection, by: 30 
 
 (i) The Legislative Policy Committee; or 31  10 	SENATE BILL 357  
 
 
 
 (ii) 1. The Governor; and 1 
 
 2. The Attorney General. 2 
 
21–2C–14. 3 
 
 [(a) If a plan of action is approved under § 21–2C–13(d) of this subtitle] IN 4 
ACCORDANCE WITH THE PLAN OF ACTION APPRO VED BY THE LEGISLATIVE POLICY 5 
COMMITTEE ON OCTOBER 22, 2024, the Board may set upper payment limits for 6 
prescription drug products that are: 7 
 
 (1) Purchased or paid for by a unit of State or local government or an 8 
organization on behalf of a unit of State or local government, including: 9 
 
 (i) State or county correctional facilities; 10 
 
 (ii) State hospitals; and 11 
 
 (iii) Health clinics at State institutions of higher education; 12 
 
 (2) Paid for through a health benefit plan on behalf of a unit of State or 13 
local government, including a county, bicounty, or municipal employee health benefit plan; 14 
or 15 
 
 (3) Purchased for or paid for by the Maryland State Medical Assistance 16 
Program. 17 
 
 [(b) The upper payment limits set under subsection (a) of this section shall: 18 
 
 (1) Be for prescription drug products that have led or will lead to an 19 
affordability challenge; and 20 
 
 (2) Be set in accordance with the criteria established in regulations 21 
adopted by the Board. 22 
 
 (c) (1) The Board shall: 23 
 
 (i) Monitor the availability of any prescription drug product for 24 
which it sets an upper payment limit; and 25 
 
 (ii) If there becomes a shortage of the prescription drug product in 26 
the State, reconsider whether the upper payment limit should be suspended or altered. 27 
   	SENATE BILL 357 	11 
 
 
 (2) An upper payment limit set under subsection (a) of this section may not 1 
be applied to a prescription drug product while the prescription drug product is on the 2 
federal Food and Drug Administration prescription drug shortage list.] 3 
 
[21–2C–16. 4 
 
 On or before December 1, 2026, the Board, in consultation with the Stakeholder 5 
Council, shall report to the Senate Finance Committee and the House Health and 6 
Government Operations Committee, in accordance with § 2–1257 of the State Government 7 
Article, on: 8 
 
 (1) The legality, obstacles, and benefits of setting upper payment limits on 9 
all purchases and payor reimbursements of prescription drug products in the State; and 10 
 
 (2) Recommendations regarding whether the General Assembly should 11 
pass legislation to expand the authority of the Board to set upper payment limits to all 12 
purchases and payor reimbursements of prescription drug products in the State.] 13 
 
21–2C–16. 14 
 
 (A) (1) THE BOARD, IN CONSULTATION WITH THE STAKEHOLDER 15 
COUNCIL, SHALL DETERMINE WHET HER, IN ADDITION TO SETTI NG UPPER PAY MENT 16 
LIMITS IN ACCORDANCE WITH § 21–2C–14 OF THIS SUBTITLE , IT IS IN THE BEST 17 
INTEREST OF THE STATE FOR THE BOARD TO ESTABLISH A PROCESS FOR SETTING 18 
UPPER PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR REIMBURSEMENTS OF 19 
PRESCRIPTION DRUG PR ODUCTS IN THE STATE THAT THE BOARD DETERMINES 20 
HAVE LED OR WILL LEA D TO AN AFFORDABILIT Y CHALLENGE . 21 
 
 (2) WHEN MAKING A DETERMI NATION UNDER PARAGRA PH (1) OF 22 
THIS SUBSECTION , THE BOARD SHALL CONSIDER , IF APPLICABLE: 23 
 
 (I) CONTRACT AND BUDGET D ATA PROVIDED TO THE BOARD 24 
THAT DEMONSTRATES SAVINGS TO THE STATE OR LOCAL GOVERN MENTS AS A 25 
RESULT OF UPPER PAYM ENT LIMITS SET IN AC CORDANCE WITH § 21–2C–14 OF THIS 26 
SUBTITLE; 27 
 
 (II) SUCCESS OF SETTING UP PER PAYMENT LIMITS I N OTHER 28 
STATES; AND 29 
 
 (III) EXPECTED SAVINGS FROM MEDICARE MAXIMUM FAIR 30 
PRICES SET BY THE CENTERS FOR MEDICARE AND MEDICAID SERVICES. 31 
 
 (B) (1) IF THE BOARD MAKES AN AFFIRM ATIVE DETERMINATION UNDER 32 
SUBSECTION (A) OF THIS SECTION , THE BOARD, IN CONSULTATION WITH THE 33  12 	SENATE BILL 357  
 
 
STAKEHOLDER COUNCIL, SHALL ESTABLISH A PR OCESS FOR SETTING UP PER 1 
PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR REIMBURSEMENTS OF 2 
PRESCRIPTION DRUG PRODUCTS I N THE STATE THAT THE BOARD DETERMINES 3 
HAVE LED OR WILL LEA D TO AN AFFORDABILIT Y CHALLENGE . 4 
 
 (2) THE PROCESS ESTABLISH ED UNDER PARAGRAPH (1) OF THIS 5 
SUBSECTION SHALL : 6 
 
 (I) TO THE EXTENT APPROPR IATE, USE THE PLAN OF ACTI ON 7 
APPROVED U NDER § 21–2C–13(D) OF THIS SUBTITLE; AND 8 
 
 (II) OTHERWISE COMPLY WITH THE REQUIREMENTS FOR 9 
SETTING UPPER PAYMEN T LIMITS ESTABLISHED UNDER THIS SUBTITLE . 10 
 
 (3) BEFORE ESTABLISHING A N UPPER PAYMENT LIMI T THAT APPLIES 11 
TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM, THE BOARD SHALL CONFER 12 
WITH THE MARYLAND MEDICAL ASSISTANCE PROGRAM TO APPROVE TH E 13 
APPLICATION OF THE U PPER PAYMENT LIMIT B Y ASSESSING WHETHER THE 14 
PROPOSED UPPER PAYME NT LIMIT WILL: 15 
 
 (I) CONFLICT WITH THE MEDICAID DRUG REBATES 16 
PROGRAM, THE COVERED OUTPATIENT DRUG RULE (CMS–2345–FC), OR ANY 17 
OTHER FEDERAL REQUIR EMENTS AS APPLICABLE ; AND 18 
 
 (II) REQUIRE ADDITIONAL FU NDING TO BE ALLOCATE D TO THE 19 
MARYLAND MEDICAL ASSISTANCE PROGRAM BUDGET .  20 
 
 SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Ma ryland read 21 
as follows: 22 
 
Article – Health – General 23 
 
21–2C–16. 24 
 
 (C) (1) IF SUBJECT TO PARAGRAPH (2) OF THIS SUBSECTION , IF THE 25 
BOARD ESTABLISHES A P ROCESS UNDER SUBSECT ION (B) OF THIS SECTION , THE 26 
BOARD SHALL SET UPPER PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR 27 
REIMBURSEMENTS OF PR ESCRIPTION DRUG PROD UCTS IN THE STATE IN 28 
ACCORDANCE WITH THE PROCESS.  29 
 
 (2) THIS SUBSECTION DOES NOT APPLY WITH RESPE CT TO: 30 
 
 (I) PAYOR REIMBURSEMENTS UNDER MEDICARE PART C AND 31 
D PLANS; 32   	SENATE BILL 357 	13 
 
 
 
 (II) PURCHASES UNDER THE F EDERAL 340B DRUG PRICING 1 
PROGRAM; AND 2 
 
 (III) PURCHASES AND PAYOR R	EIMBURSEMENTS UNDER 3 
FEDERAL PROGRAMS THA T ARE PREEMPTED BY F EDERAL LAW INCLUDING : 4 
 
 1. THE DEPARTMENT OF DEFENSE; 5 
 
 2. THE DEPARTMENT OF VETERANS AFFAIRS; 6 
 
 3. THE PUBLIC HEALTH SERVICE; 7 
 
 4. THE UNITED STATES COAST GUARD; 8 
 
 5. TRICARE; 9 
 
 6. THE FEDERAL EMPLOYEES HEALTH BENEFIT PLAN; 10 
AND 11 
 
 7. ANY OTHER EXCLUSIVE F EDERAL PROGRAM AS 12 
APPLICABLE.  13 
 
 SECTION 3. AND BE IT FURTHER ENACTED, That: 14 
 
 (a) Section 2 of this Act is contingent on the Prescription Drug Affordability Board 15 
setting upper payment limits on two prescription drugs in accordance with § 21–2C–14 of 16 
the Health – General Article, as enacted by Section 1 of this Act, and each upper payment 17 
limit being in effect for 1 year. 18 
 
 (b) Within 5 days after the conditions described in subsection (a) of this section 19 
are met, the Prescription Drug Affordability Board shall notify the Department of 20 
Legislative Services. 21 
 
 (c) If notice is received by the Department of Legislative Services in accordance 22 
with subsection (b) of this section on or before September 31 September 30, 2030, Section 2 23 
of this Act shall take effect on the date the notice is received by the Department of 24 
Legislative Services. 25 
 
 (d) If notice is not received by the Department of Legislative Services on or before 26 
December 31 September 30, 2030, Section 2 of this Act, with no further action required by 27 
the General Assembly, shall be null and void. 28 
 
 SECTION 4. AND BE IT FURTHER ENACTED, That, subject to Section 3 of this 29 
Act, this Act shall take effect October 1, 2025. 30