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.
Italics indicate opposite chamber/conference committee amendments.
*sb0357*
SENATE BILL 357
J1, J5 (5lr2092)
ENROLLED BILL
— Finance/Health and Government Operations —
Introduced by Senators Gile and Feldman, Feldman, and Hester
Read and Examined by Proofreaders:
_______________________________________________
Proofreader.
_______________________________________________
Proofreader.
Sealed with the Great Seal and presented to the Governor, for his approval this
_______ day of _______________ at ________________________ o’clock, ________M.
______________________________________________
President.
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 2 SENATE BILL 357
BY repealing and reenacting, with amendments, 1
Article – Health – General 2
Section 21–2C–01, 21–2C–04, 21–2C–13, and 21–2C–14 3
Annotated Code of Maryland 4
(2023 Replacement Volume and 2024 Supplement) 5
BY repealing and reenacting, without amendments, 6
Article – Health – General 7
Section 21–2C–09(c) and 21–2C–11(a) 8
Annotated Code of Maryland 9
(2023 Replacement Volume and 2024 Supplement) 10
BY adding to 11
Article – Health – General 12
Section 21–2C–09(d) and (e) and 21–2C–16 13
Annotated Code of Maryland 14
(2023 Replacement Volume and 2024 Supplement) 15
BY repealing 16
Article – Health – General 17
Section 21–2C–11(d) and 21–2C–16 18
Annotated Code of Maryland 19
(2023 Replacement Volume and 2024 Supplement) 20
BY adding to 21
Article – Health – General 22
Section 21–2C–16 23
Annotated Code of Maryland 24
(2023 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
Article – Health – General 28
21–2C–01. 29
(a) In this subtitle the following words have the meanings indicated. 30
(b) “Biologic” means a drug that is produced or distributed in accordance with a 31
biologics license application approved under 42 C.F.R. § 447.502. 32
(c) “Biosimilar” means a drug that is produced or distributed in accordance with 33
a biologics license application approved under 42 U.S.C. § 262(k)(3). 34
(d) “Board” means the Prescription Drug Affordability Board. 35 SENATE BILL 357 3
(e) (1) “Brand name drug” means a drug that is produced or distributed in 1
accordance with an original new drug application approved under 21 U.S.C. § 355(c). 2
(2) “Brand name drug” does not include an authorized generic as defined 3
by 42 C.F.R. § 447.502. 4
(F) “CURRENT SHORTAGE ” MEANS A DRUG : 5
(1) LISTED AS CURRENT ON THE FEDERAL FOOD AND DRUG 6
ADMINISTRATION ’S DRUG SHORTAGE DATABASE; OR 7
(2) OTHERWISE DETERMINED BY THE BOARD TO BE IN SHORT 8
SUPPLY IN THE STATE. 9
[(f)] (G) “Generic drug” means: 10
(1) A retail drug that is marketed or distributed in accordance with an 11
abbreviated new drug application, approved under 21 U.S.C. § 355(j); 12
(2) An authorized generic as defined by 42 C.F.R. § 447.502; or 13
(3) A drug that entered the market before 1962 that was not originally 14
marketed under a new drug application. 15
[(g)] (H) “Manufacturer” means an entity that: 16
(1) (i) Engages in the manufacture of a prescription drug product; or 17
(ii) Enters into a lease with another manufacturer to market and 18
distribute a prescription drug product under the entity’s own name; and 19
(2) Sets or changes the wholesale acquisition cost of the prescription drug 20
product it manufactures or markets. 21
[(h)] (I) “Prescription drug product” means a brand name drug, a generic drug, 22
a biologic, or a biosimilar. 23
[(i)] (J) “Stakeholder Council” means the Prescription Drug Affordability 24
Stakeholder Council. 25
21–2C–04. 26
(a) There is a Prescription Drug Affordability Stakeholder Council. 27
4 SENATE BILL 357
(b) The purpose of the Stakeholder Council is to provide stakeholder input to 1
assist the Board in making decisions as required under this subtitle. 2
(c) (1) The Stakeholder Council consists of [26] members appointed in 3
accordance with this subsection. 4
(2) The Speaker of the House of Delegates shall appoint: 5
(i) One representative of generic drug corporations; 6
(ii) One representative of nonprofit insurance carriers; 7
(iii) One representative of a statewide health care advocacy coalition; 8
(iv) One representative of a statewide advocacy organization for 9
seniors; 10
(v) One representative of a statewide organization for diverse 11
communities; 12
(vi) One representative of a labor union; 13
(vii) ONE REPRESENTATIVE OF THE RARE DISEASE COM MUNITY; 14
(VIII) One health services researcher specializing in prescription 15
drugs; and 16
[(viii)] (IX) One public member at the discretion of the Speaker of the 17
House of Delegates. 18
(3) The President of the Senate shall appoint: 19
(i) One representative of brand name drug corporations; 20
(ii) One representative of physicians; 21
(iii) One representative of nurses; 22
(iv) One representative of hospitals; 23
(v) One representative of dentists; 24
(vi) ONE REPRESENTATIVE OF ONCOLOGISTS ; 25
(VII) One representative of managed care organizations; 26
SENATE BILL 357 5
[(vii)] (VIII) One representative of the Department of Budget and 1
Management; 2
[(viii)] (IX) One clinical researcher; and 3
[(ix)] (X) One public member at the discretion of the President of 4
the Senate. 5
(4) The Governor shall appoint: 6
(i) One representative of brand name drug corporations; 7
(ii) One representative of generic drug corporations; 8
(iii) One representative of biotechnology companies; 9
(iv) One representative of for–profit health insurance carriers; 10
(v) One representative of employers; 11
(vi) One representative of pharmacy benefits managers; 12
(vii) One representative of pharmacists; 13
(viii) One pharmacologist; [and] 14
(ix) ONE REPRESENTATIVE OF A PATIENT ADVOCACY 15
ORGANIZATION ; AND 16
(X) One public member at the discretion of the Governor. 17
(5) Collectively, the members of the Stakeholder Council shall have 18
knowledge of the following: 19
(i) The pharmaceutical business model; 20
(ii) Supply chain business models; 21
(iii) The practice of medicine or clinical training; 22
(iv) Consumer or patient perspectives; 23
(v) Health care costs trends and drivers; 24
(vi) Clinical and health services research; or 25
6 SENATE BILL 357
(vii) The State’s health care marketplace. 1
(6) To the extent practicable and consistent with federal and State law, the 2
membership of the Stakeholder Council shall reflect the racial, ethnic, and gender diversity 3
of the State. 4
(7) From among the membership of the Stakeholder Council, the Board 5
chair shall appoint two members to be cochairs of the Stakeholder Council. 6
(d) (1) The term of a member is 3 years. 7
(2) The initial members of the Stakeholder Council shall serve staggered 8
terms as required by the terms provided for members on October 1, 2019. 9
(e) A member of the Stakeholder Council: 10
(1) May not receive compensation as a member of the Stakeholder Council; 11
but 12
(2) Is entitled to reimbursement for expenses under the Standard State 13
Travel Regulations, as provided in the State budget. 14
21–2C–09. 15
(c) On or before December 31, 2020, and each December 31 thereafter, the Board 16
shall submit to the Senate Finance Committee and the House Health and Government 17
Operations Committee, in accordance with § 2–1257 of the State Government Article, a 18
report that includes: 19
(1) Price trends for prescription drug products; 20
(2) The number of prescription drug products that were subject to Board 21
review and the results of the review; and 22
(3) Any recommendations the Board may have on further legislation 23
needed to make prescription drug products more affordable in the State. 24
(D) IF THE BOARD SETS A NEW UPPER PAYMENT LI MIT, TO THE EXTENT 25
PRACTICABLE, THE BOARD SHALL INCLUDE I N THE FIRST REPORT T HAT IS 26
REQUIRED UNDER SUBSE CTION (C) OF THIS SECTION AFTE R THE UPPER PAYMENT 27
LIMIT HAS BEEN IN EF FECT FOR 1 YEAR INFORMATION ON THE EFFECTS OF THE 28
UPPER PAYME NT LIMIT, BASED ON AVAILABLE T IMELY DATA, FOR THE FOLLOWING : 29
(1) PATIENT OUT–OF–POCKET COSTS INCLUDI NG WHETHER THE 30
UPPER PAYMENT LIMIT WAS ASSOCIATED WITH INCREASES OR DECREAS ES IN WHAT 31
PATIENTS PAY FOR PRE SCRIPTION DRUG PRODU CTS; 32 SENATE BILL 357 7
(2) PATIENT HEALTH INSURANCE PREMIUMS , INCLUDING WHETHER 1
THE UPPER PAYMENT LI MIT IS ASSOCIATED WI TH INCREASES OR DECR EASES IN 2
HEALTH INSURANCE COS TS FOR PATIENTS; 3
(3) PHARMACIES OPERATING IN THE STATE, INCLUDING THE IMPACT 4
ON REIMBURSEMENT RAT ES AND FINANCIAL VIA BILITY OF RETAIL AND 5
INDEPENDENT PHARMACI ES; 6
(4) PATIENT HEALTH INSURA NCE FORMULARIES , INCLUDING 7
WHETHER THE PRESCRIP TION DRUG PRODUCT SU BJECT TO THE UPPER P AYMENT 8
LIMIT REMAINED ON FO RMULARIES; 9
(5) PROVIDER–ADMINISTERED MEDICAT IONS SUBJECT TO THE 10
UPPER PAYMENT LIMIT , INCLUDING WHETHER PR OVIDERS WERE ABLE TO ACQUIRE 11
THE PRESCRIPTION DRU G PRODUCT SUBJECT TO THE UPPER PAYMENT LI MIT AT A 12
RATE TO ACCOUNT FOR ACQUISITION COSTS AN D WHETHER THERE WAS AN IMPACT 13
ON PROVIDER REIMBURS EMENT; 14
(6) PATIENT ACCESS TO THE PRESCRIPTION DRU G PRODUCT 15
SUBJECT TO THE UPPER PAYMENT LIMIT , WHICH MAY INCLUDE : 16
(I) WHETHER PRESCRIPTION DRUG PRODUCT SHORTAG ES OR 17
OTHER SUPPLY DISRUPT IONS OCCURRED AFTER THE UPPER PAYMENT LI MIT TOOK 18
EFFECT; 19
(II) WHETHER FORMULARY PLA CEMENT OR PLAN DESIGN 20
CHANGES MADE THE PRE SCRIPTION DRUG PRODU CT SUBJECT TO THE UP PER LIMIT 21
MORE DIFFICULT FOR P ATIENTS TO ACCESS , INCLUDING IF INSURAN CE PLANS 22
PREFERRED A PRESCRIP TION DRUG PRODUCT WI THOUT AN UPPER PAYME NT LIMIT 23
OVER A PRESCRIPTION DRUG PRODUCT SUB JECT TO AN UPPER PAY MENT LIMIT; 24
(III) WHETHER THE DISTRIBUT ION AND DELIVERY OF 25
SPECIALTY OR RARE DI SEASE MEDICATIONS FR OM OUT–OF–STATE PHARMACIES TO 26
PROVIDERS, PHARMACIES , OR PATIENTS WAS IMPA CTED; 27
(IV) WHETHER PATIENTS IN C OMMUNITIES OF COLOR , 28
PATIENTS WHO ARE WOMEN , PATIENTS WITH A RARE DISEASE, OR PATIENTS IN 29
RURAL AREAS EXPERIEN CED DISPROPORTIONATE ACCESS CHALLENGES ; AND 30
(V) WHETHER COST DIFFEREN CES AS A RESULT OF T HE UPPER 31
PAYMENT LIMIT AFFECT ED PATIENTS, PHARMACIES , OR PROVIDERS AND , IF THE 32
COST DIFFERENCE RESU LTED IN AN INCREASE IN COSTS, WHO WAS ULTIMATELY 33
RESPONSIBLE FOR BEAR ING THE INCREASED CO ST; 34 8 SENATE BILL 357
(7) COVERED ENTITY PROVID ERS PARTICIPATING IN THE 340B DRUG 1
DISCOUNT PROGRAM , INCLUDING THE IMPACT OF THE UPPER PAYMENT LIMIT ON 2
THE OPERATIONS OF THE PROVI DERS AND THEIR CONTR ACTED PHARMACIES ; AND 3
(8) THE BIOTECHNOLOGY IND USTRY IN THE STATE, INCLUDING THE 4
IMPACT ON PHARMACEUT ICAL RESEARCH AND DE VELOPMENT , INVESTMENT, AND 5
JOB GROWTH . 6
(E) (1) THE BOARD MAY REQUEST INF ORMATION NECESSARY TO 7
COMPLETE THE REPORT REQUIRED UNDER SUBSE CTIONS (C) AND (D) OF THIS 8
SECTION FROM AN AFFE CTED ENTITY. 9
(2) THE ENTITY FROM WHICH INFORMATION WAS REQU ESTED UNDER 10
PARAGRAPH (1) OF THIS SUBSECTION S HALL MAKE A GOOD FAI TH EFFORT TO 11
PROVIDE THE REQUESTE D INFORMATION. 12
21–2C–11. 13
(a) In this section, “Fund” means the Prescription Drug Affordability Fund. 14
[(d) (1) The Board shall be established using special or general funds, which 15
shall be repaid to the State with the funds from the Fund. 16
(2) If the Board receives funding from the Maryland Health Care 17
Commission under paragraph (1) of this subsection, the Board shall repay the funds to the 18
Commission from the Fund over a 3–year period beginning June 1, 2021.] 19
21–2C–13. 20
(a) If, under § 21–2C–07 of this subtitle, the Board finds that it is in the best 21
interest of the State to establish a process for setting upper payment limits for prescription 22
drug products that it determines have led or will lead to an affordability challenge, the 23
Board, in conjunction with the Stakeholder Council, shall draft a plan of action for 24
implementing the process [that includes the criteria the Board shall use to set upper 25
payment limits] IN ACCORDANCE WITH T HE REQUIREMENTS OF T HIS SECTION. 26
(b) The criteria for setting upper payment limits shall include consideration of: 27
(1) The cost of administering the prescription drug product; 28
(2) The cost of delivering the prescription drug product to consumers; [and] 29
(3) THE EFFECT THE UPPER PAYMENT LIMIT WILL H AVE ON 30
PROVIDERS OF 340B DRUGS; 31 SENATE BILL 357 9
(4) FOR AN UPPER PAYMENT LIMIT ON A DRUG THAT IS DESIGNATED 1
AS A DRUG FOR A RARE DISEASE OR CONDITION , THE IMPACT OF THE UP PER 2
PAYMENT LIMIT ON PAT IENTS WITH RARE DISE ASES; AND 3
[(3)] (4) (5) Other relevant administrative costs related to the prescription 4
drug product. 5
[(c) The process for setting upper payment limits shall: 6
(1) Prohibit the application of an upper payment limit for a prescription 7
drug product that is on the federal Food and Drug Administration prescription drug 8
shortage list; and 9
(2) Require the Board to: 10
(i) Monitor the availability of any prescription drug product for 11
which it sets an upper payment limit; and 12
(ii) If there becomes a shortage of the prescription drug product in 13
the State, reconsider or suspend the upper payment limit.] 14
(C) (1) IF THE BOARD PREVIOUSLY SET AN UPPER PAYMENT LIM IT FOR A 15
DRUG THAT BECOMES A CURRENT SHORTAGE , THE BOARD MAY RECONSIDER THE 16
PREVIOUSLY SET UPPER PAYMENT LIMIT . 17
(2) THE BOARD MAY NOT : 18
(I) ESTABLISH APPLY A NEW UPPER PAYMENT LIMIT FOR TO A 19
DRUG IN A CURRENT SHORTAGE ; 20
(II) ENFORCE AN UPPER PAYM ENT LIMIT AGAINST PR OVIDER 21
OR PHARMACY REIMBURS EMENT REQUIREMENTS F OR MEDICARE PART C OR PART 22
D PLANS; OR 23
(III) COUNT A PHARMACY DISP ENSING FE E TOWARD OR 24
SUBJECT A PHARMACY D ISPENSING FEE TO AN UPPER PAYMENT LIMIT . 25
(d) (1) If a plan of action is drafted under subsection (a) of this section, the 26
Board shall submit the plan of action to the Legislative Policy Committee of the General 27
Assembly, in accordance with § 2–1257 of the State Government Article, for its approval. 28
(2) The Legislative Policy Committee shall have 45 days to approve the 29
plan of action. 30
10 SENATE BILL 357
(3) If the Legislative Policy Committee does not approve the plan of action, 1
the Board shall submit the plan to the Governor and the Attorney General for approval. 2
(4) The Governor and the Attorney General shall have 45 days to approve 3
the plan of action. 4
(5) The Board may not set upper payment limits unless the plan is 5
approved, in accordance with this subsection, by: 6
(i) The Legislative Policy Committee; or 7
(ii) 1. The Governor; and 8
2. The Attorney General. 9
21–2C–14. 10
[(a) If a plan of action is approved under § 21–2C–13(d) of this subtitle] IN 11
ACCORDANCE WITH THE PLAN OF ACTION APPRO VED BY THE LEGISLATIVE POLICY 12
COMMITTEE ON OCTOBER 22, 2024, the Board may set upper payment limits THROUGH 13
REGULATIONS for prescription drug products that are: 14
(1) Purchased or paid for by a unit of State or local government or an 15
organization on behalf of a unit of State or local government, including: 16
(i) State or county correctional facilities; 17
(ii) State hospitals; and 18
(iii) Health clinics at State institutions of higher education; 19
(2) Paid for through a health benefit plan on behalf of a unit of State or 20
local government, including a county, bicounty, or municipal employee health benefit plan; 21
or 22
(3) Purchased for or paid for by the Maryland State Medical Assistance 23
Program. 24
[(b) The upper payment limits set under subsection (a) of this section shall: 25
(1) Be for prescription drug products that have led or will lead to an 26
affordability challenge; and 27
(2) Be set in accordance with the criteria established in regulations 28
adopted by the Board. 29
SENATE BILL 357 11
(c) (1) The Board shall: 1
(i) Monitor the availability of any prescription drug product for 2
which it sets an upper payment limit; and 3
(ii) If there becomes a shortage of the prescription drug product in 4
the State, reconsider whether the upper payment limit should be suspended or altered. 5
(2) An upper payment limit set under subsection (a) of this section may not 6
be applied to a prescription drug product while the prescription drug product is on the 7
federal Food and Drug Administration prescription drug shortage list.] 8
[21–2C–16. 9
On or before December 1, 2026, the Board, in consultation with the Stakeholder 10
Council, shall report to the Senate Finance Committee and the House Health and 11
Government Operations Committee, in accordance with § 2–1257 of the State Government 12
Article, on: 13
(1) The legality, obstacles, and benefits of setting upper payment limits on 14
all purchases and payor reimbursements of prescription drug products in the State; and 15
(2) Recommendations regarding whether the General Assembly should 16
pass legislation to expand the authority of the Board to set upper payment limits to all 17
purchases and payor reimbursements of prescription drug products in the State.] 18
21–2C–16. 19
(A) (1) THE BOARD, IN CONSULTATION WITH THE STAKEHOLDER 20
COUNCIL, SHALL DETERMINE WHET HER, IN ADDITION TO SETTI NG UPPER PAYMENT 21
LIMITS IN ACCORDANCE WITH § 21–2C–14 OF THIS SUBTITLE , IT IS IN THE BEST 22
INTEREST OF THE STATE FOR THE BOARD TO ESTABLISH A PROCESS FOR S ETTING 23
UPPER PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR REIMBURSEMENTS OF 24
PRESCRIPTION DRUG PR ODUCTS IN THE STATE THAT THE BOARD DETERMINES 25
HAVE LED OR WILL LEA D TO AN AFFORDABILIT Y CHALLENGE . 26
(2) WHEN MAKING A DETERMI NATION UNDER PARAGRA PH (1) OF 27
THIS SUBSECTION, THE BOARD SHALL CONSIDER , IF APPLICABLE: 28
(I) CONTRACT AND BUDGET D ATA PROVIDED TO THE BOARD 29
THAT DEMONSTRATES SA VINGS TO THE STATE OR LOCAL GOVERN MENTS AS A 30
RESULT OF UPPER PAYM ENT LIMITS SET IN AC CORDANCE WITH § 21–2C–14 OF THIS 31
SUBTITLE; 32
12 SENATE BILL 357
(II) SUCCESS OF SETTING UP PER PAYMENT LIMITS I N OTHER 1
STATES; AND 2
(III) EXPECTED SAVINGS FROM MEDICARE MAXIMUM FAIR 3
PRICES SET BY THE CENTERS FOR MEDICARE AND MEDICAID SERVICES. 4
(B) (1) IF THE BOARD MAKES AN AFFIRM ATIVE DETERMINATION UNDER 5
SUBSECTION (A) OF THIS SECTION , THE BOARD, IN CONSULTATION WITH THE 6
STAKEHOLDER COUNCIL, SHALL ESTABLISH A PR OCESS FOR SETTING UP PER 7
PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR REIMBURSEMENTS OF 8
PRESCRIPTION DRUG PR ODUCTS IN THE STATE THAT THE BOARD DETERMINES 9
HAVE LED OR WILL LEAD TO AN AFFORDABILITY CHALLENGE . 10
(2) THE PROCESS ESTABLISH ED UNDER PARAGRAPH (1) OF THIS 11
SUBSECTION SHALL : 12
(I) TO THE EXTENT APPROPR IATE, USE THE PLAN OF ACTI ON 13
APPROVED UNDER § 21–2C–13(D) OF THIS SUBTITLE; AND 14
(II) OTHERWISE COMPLY WITH THE REQU IREMENTS FOR 15
SETTING UPPER PAYMEN T LIMITS ESTABLISHED UNDER THIS SUBTITLE . 16
(3) BEFORE ESTABLISHING A N UPPER PAYMENT LIMI T THAT APPLIES 17
TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM, THE BOARD SHALL CONFER 18
WITH THE MARYLAND MEDICAL ASSISTANCE PROGRAM TO APPROVE TH E 19
APPLICATION OF THE U PPER PAYMENT LIMIT B Y ASSESSING WHETHER THE 20
PROPOSED UPPER PAYME NT LIMIT WILL: 21
(I) CONFLICT WITH THE MEDICAID DRUG REBATES 22
PROGRAM, THE COVERED OUTPATIENT DRUG RULE (CMS–2345–FC), OR ANY 23
OTHER FEDERAL REQUIREMENTS AS APPL ICABLE; AND 24
(II) REQUIRE ADDITIONAL FU NDING TO BE ALLOCATE D TO THE 25
MARYLAND MEDICAL ASSISTANCE PROGRAM BUDGET . 26
SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 27
as follows: 28
Article – Health – General 29
21–2C–16. 30
(C) (1) IF SUBJECT TO PARAGRAPH (2) OF THIS SUBSECTION , IF THE 31
BOARD ESTABLISHES A P ROCESS UNDER SUBSECT ION (B) OF THIS SECTION , THE 32 SENATE BILL 357 13
BOARD SHALL SET UPPER PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR 1
REIMBURSEMENTS OF PR ESCRIPTION DRUG PROD UCTS IN THE STATE IN 2
ACCORDANCE WITH THE PROCESS. 3
(2) THIS SUBSECTION DOES NOT APPLY WITH RESPE CT TO: 4
(I) PAYOR REIMBURSEMENTS UNDER MEDICARE PART C AND 5
D PLANS; 6
(II) PURCHASES UNDER THE F EDERAL 340B DRUG PRICING 7
PROGRAM; AND 8
(III) PURCHASES AND PAYOR R EIMBURSEMENTS UNDER BY 9
FEDERAL AGENCIES OR FEDERAL PROGRAMS THA T ARE THE STATE IS PREEMPTED 10
FROM REGULATING BY FEDERAL LAW INCLUDING: 11
1. THE DEPARTMENT OF DEFENSE; 12
2. THE DEPARTMENT OF VETERANS AFFAIRS; 13
3. THE PUBLIC HEALTH SERVICE; 14
4. THE UNITED STATES COAST GUARD; 15
5. TRICARE; 16
6. THE FEDERAL EMPLOYEES HEALTH BENEFIT PLAN; 17
AND 18
7. ANY OTHER EXCLUSIVE F EDERAL PROGRAM AS 19
APPLICABLE. 20
SECTION 3. AND BE IT FURTHER ENACTED, That: 21
(a) Section 2 of this Act is contingent on the Prescription Drug Affordability Board 22
setting upper payment limits on two prescription drugs in accordance with § 21–2C–14 of 23
the Health – General Article, as enacted by Section 1 of this Act, and each upper payment 24
limit being in effect for 1 year. 25
(b) Within 5 days after the conditions described in subsection (a) of this section 26
are met, the Prescription Drug Affordability Board shall notify the Department of 27
Legislative Services. 28
(c) If notice is received by the Department of Legislative Services in accordance 29
with subsection (b) of this section on or before September 31 September 30, 2030, Section 2 30 14 SENATE BILL 357
of this Act shall take effect on the date the notice is received by the Department of 1
Legislative Services. 2
(d) If notice is not received by the Department of Legislative Services on or before 3
December 31 September 30, 2030, Section 2 of this Act, with no further action required by 4
the General Assembly, shall be null and void. 5
SECTION 4. AND BE IT FURTHER ENACTED, That, subject to Section 3 of this 6
Act, this Act shall take effect October 1, 2025. 7
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
President of the Senate.
________________________________________________________________________________
Speaker of the House of Delegates.