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.
*hb0424*
HOUSE BILL 424
J1, J5 (5lr2044)
ENROLLED BILL
— Health and Government Operations/Finance —
Introduced by Delegates Cullison and White Holland, White Holland, Alston,
Bagnall, Bhandari, Guzzone, Hill, S. Johnson, Kaiser, Kerr, Lopez,
Martinez, Pena–Melnyk, Rosenberg, Taveras, Woods, and Woorman
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.
______________________________________________
Speaker.
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 2 HOUSE BILL 424
the Board from taking certain actions related to upper payment limits; and generally 1
relating to the Prescription Drug Affordability Board. 2
BY repealing and reenacting, with amendments, 3
Article – Health – General 4
Section 21–2C–01, 21–2C–04, 21–2C–13, and 21–2C–14 5
Annotated Code of Maryland 6
(2023 Replacement Volume and 2024 Supplement) 7
BY repealing and reenacting, without amendments, 8
Article – Health – General 9
Section 21–2C–09(c) and 21–2C–11(a) 10
Annotated Code of Maryland 11
(2023 Replacement Volume and 2024 Supplement) 12
BY adding to 13
Article – Health – General 14
Section 21–2C–09(d) and (e) and 21–2C–16 15
Annotated Code of Maryland 16
(2023 Replacement Volume and 2024 Supplement) 17
BY repealing 18
Article – Health – General 19
Section 21–2C–11(d) and 21–2C–16 20
Annotated Code of Maryland 21
(2023 Replacement Volume and 2024 Supplement) 22
BY adding to 23
Article – Health – General 24
Section 21–2C–16 25
Annotated Code of Maryland 26
(2023 Replacement Volume and 2024 Supplement) 27
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 28
That the Laws of Maryland read as follows: 29
Article – Health – General 30
21–2C–01. 31
(a) In this subtitle the following words have the meanings indicated. 32
(b) “Biologic” means a drug that is produced or distributed in accordance with a 33
biologics license application approved under 42 C.F.R. § 447.502. 34
(c) “Biosimilar” means a drug that is produced or distributed in accordance with 35
a biologics license application approved under 42 U.S.C. § 262(k)(3). 36 HOUSE BILL 424 3
(d) “Board” means the Prescription Drug Affordability Board. 1
(e) (1) “Brand name drug” means a drug that is produced or distributed in 2
accordance with an original new drug application approved under 21 U.S.C. § 355(c). 3
(2) “Brand name drug” does not include an authorized generic as defined 4
by 42 C.F.R. § 447.502. 5
(F) “CURRENT SHORTAGE” MEANS A DRUG : 6
(1) LISTED AS CURRENT ON THE FEDERAL FOOD AND DRUG 7
ADMINISTRATION ’S DRUG SHORTAGE DATABASE; OR 8
(2) OTHERWISE DETERMINED BY THE BOARD TO BE IN SHORT 9
SUPPLY IN THE STATE. 10
[(f)] (G) “Generic drug” means: 11
(1) A retail drug that is marketed or distributed in accordance with an 12
abbreviated new drug application, approved under 21 U.S.C. § 355(j); 13
(2) An authorized generic as defined by 42 C.F.R. § 447.502; or 14
(3) A drug that entered the market before 1962 that was not originally 15
marketed under a new drug application. 16
[(g)] (H) “Manufacturer” means an entity that: 17
(1) (i) Engages in the manufacture of a prescription drug product; or 18
(ii) Enters into a lease with another manufacturer to market and 19
distribute a prescription drug product under the entity’s own name; and 20
(2) Sets or changes the wholesale acquisition cost of the prescription drug 21
product it manufactures or markets. 22
[(h)] (I) “Prescription drug product” means a brand name drug, a generic drug, 23
a biologic, or a biosimilar. 24
[(i)] (J) “Stakeholder Council” means the Prescription Drug Affordability 25
Stakeholder Council. 26
21–2C–04. 27
(a) There is a Prescription Drug Affordability Stakeholder Council. 28 4 HOUSE BILL 424
(b) The purpose of the Stakeholder Council is to provide stakeholder input to assist 1
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 drugs; 15
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 HOUSE BILL 424 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 the 4
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 HOUSE BILL 424
(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 needed 23
to make prescription drug products more affordable in the State. 24
(D) IF THE BOARD SETS A NEW UPPE R PAYMENT LIMIT , 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 EFF ECT FOR 1 YEAR INFORMATION ON THE EFFECTS OF THE 28
UPPER PAYMENT LIMIT , BASED ON AVAILABLE T IMELY DATA, FOR THE FOLLOWING : 29
HOUSE BILL 424 7
(1) PATIENT OUT–OF–POCKET COSTS INCLUDI NG WHETHER THE 1
UPPER PAYMENT LIMIT WAS ASSOCIATED WITH INCREASES OR DECRE ASES IN WHAT 2
PATIENTS PAY FOR PRE SCRIPTION DRUG PRODU CTS; 3
(2) PATIENT HEALTH INSURA NCE PREMIUMS , INCLUDING WHETHER 4
THE UPPER PAYMENT LI MIT IS ASSOCIATED WI TH INCREASES OR DECR EASES IN 5
HEALTH INSURANCE COS TS FOR PATIENTS; 6
(3) PHARMACIES OPERATING IN THE STATE, INCLUDING THE IMPACT 7
ON REIMBURSEMENT RAT ES AND FINANCIAL VIA BILITY OF RETAIL AND 8
INDEPENDENT PHARMACI ES; 9
(4) PATIENT HEALTH INSURA NCE FORMULARIES , INCLUDING 10
WHETHER THE PRESCRIP TION DRUG PRODUCT SU BJECT TO THE UPPER P AYMENT 11
LIMIT REMAINED ON FORMULARIES ; 12
(5) PROVIDER–ADMINISTERED MEDICAT IONS SUBJECT TO THE 13
UPPER PAYMENT LIMIT , INCLUDING WHETHER PR OVIDERS WERE ABLE TO ACQUIRE 14
THE PRESCRIPTION DRU G PRODUCT SUBJECT TO THE UPPER PAYMENT LI MIT AT A 15
RATE TO ACCOUNT FOR ACQUISITION COSTS AN D WHETHER THERE WAS AN IMPACT 16
ON PROVIDER REIMBURS EMENT; 17
(6) PATIENT ACCESS TO THE PRESCRIPTION DRUG PR ODUCT 18
SUBJECT TO THE UPPER PAYMENT LIMIT, WHICH MAY INCLUDE : 19
(I) WHETHER PRESCRIPTION DRUG PRODUCT SHORTAG ES OR 20
OTHER SUPPLY DISRUPT IONS OCCURRED AF TER THE UPPER PAYMEN T LIMIT TOOK 21
EFFECT; 22
(II) WHETHER FORMULARY PLA CEMENT OR PLAN DESIG N 23
CHANGES MADE THE PRE SCRIPTION DRUG PRODU CT SUBJECT TO THE UP PER LIMIT 24
MORE DIFFICULT FOR P ATIENTS TO ACCESS , INCLUDING IF INSURAN CE PLANS 25
PREFERRED A PRESCRIP TION DRUG PRODUCT WITHOUT AN UPPER PAYMENT LIM IT 26
OVER A PRESCRIPTION DRUG PRODUCT SUBJECT TO AN UPPER PAYMENT LIMIT; 27
(III) WHETHER THE DISTRIBUT ION AND DELIVERY OF SPECIALTY 28
OR RARE DISEASE MEDI CATIONS FROM OUT –OF–STATE PHARMACIES TO PROVIDERS, 29
PHARMACIES, OR PATIENTS WAS IMPA CTED; 30
(IV) WHETHER PATIENTS IN C OMMUNITIES OF COLOR , PATIENTS 31
WHO ARE WOMEN , PATIENTS WITH A RARE DISEASE, OR PATIENTS IN RURAL AREAS 32
EXPERIENCED DISPROPO RTIONATE ACCESS CHAL LENGES; AND 33
8 HOUSE BILL 424
(V) WHETHER COST DIFFEREN CES AS A RESULT O F THE UPPER 1
PAYMENT LIMIT AFFECT ED PATIENTS, PHARMACIES, OR PROVIDERS AND , IF THE 2
COST DIFFERENCE RESU LTED IN AN INCREASE IN COSTS, WHO WAS ULTIMATELY 3
RESPONSIBLE FOR BEAR ING THE INCREASED CO ST; 4
(7) COVERED ENTITY PROVID ERS PARTICIPATING IN THE 340B DRUG 5
DISCOUNT PROGRAM , INCLUDING THE IMPACT OF THE UPPER PAYMENT LIMIT ON 6
THE OPERATIONS OF TH E PROVIDERS AND THEI R CONTRACTED PHARMAC IES; AND 7
(8) THE BIOTECHNOLOGY IND USTRY IN THE STATE, INCLUDING THE 8
IMPACT ON PHARMACEUT ICAL RESEARCH AND DE VELOPMENT , INVESTMENT, AND 9
JOB GROWTH . 10
(E) (1) THE BOARD MAY REQUEST INF ORMATION NECESSARY T O 11
COMPLETE THE REPORT REQUIRED UNDER SUBSE CTIONS (C) AND (D) OF THIS 12
SECTION FROM AN AFFE CTED ENTITY. 13
(2) THE ENTITY FROM WHICH INFORMATION WAS REQU ESTED UNDER 14
PARAGRAPH (1) OF THIS SUBSECTION S HALL MAKE A GOOD FAI TH EFFORT TO 15
PROVIDE THE REQUESTE D INFORMATION . 16
21–2C–11. 17
(a) In this section, “Fund” means the Prescription Drug Affordability Fund. 18
[(d) (1) The Board shall be established using special or general funds, which 19
shall be repaid to the State with the funds from the Fund. 20
(2) If the Board receives funding from the Maryland Health Care 21
Commission under paragraph (1) of this subsection, the Board shall repay the funds to the 22
Commission from the Fund over a 3–year period beginning June 1, 2021.] 23
21–2C–13. 24
(a) If, under § 21–2C–07 of this subtitle, the Board finds that it is in the best 25
interest of the State to establish a process for setting upper payment limits for prescription 26
drug products that it determines have led or will lead to an affordability challenge, the 27
Board, in conjunction with the Stakeholder Council, shall draft a plan of action for 28
implementing the process [that includes the criteria the Board shall use to set upper 29
payment limits] IN ACCORDANCE WITH THE REQ UIREMENTS OF THIS SE CTION. 30
(b) The criteria for setting upper payment limits shall include consideration of: 31
(1) The cost of administering the prescription drug product; 32
HOUSE BILL 424 9
(2) The cost of delivering the prescription drug product to consumers; [and] 1
(3) THE EFFECT THE UPPER PAYMENT LIMIT WILL H AVE ON 2
PROVIDERS OF 340B DRUGS; 3
(4) FOR AN UPPER PAYMENT LIMIT ON A DRUG THAT IS DESIGNATED 4
AS A DRUG FOR A RARE DISEASE OR CONDITION , THE IMPACT OF THE UP PER 5
PAYMENT LIMIT ON PAT IENTS WITH RARE DISEASES ; AND 6
[(3)] (4) (5) Other relevant administrative costs related to the prescription 7
drug product. 8
[(c) The process for setting upper payment limits shall: 9
(1) Prohibit the application of an upper payment limit for a prescription 10
drug product that is on the federal Food and Drug Administration prescription drug 11
shortage list; and 12
(2) Require the Board to: 13
(i) Monitor the availability of any prescription drug product for 14
which it sets an upper payment limit; and 15
(ii) If there becomes a shortage of the prescription drug product in 16
the State, reconsider or suspend the upper payment limit.] 17
(C) (1) IF THE BOARD PREVIOUSLY SET AN UPPER PAYMENT LIM IT FOR A 18
DRUG THAT BECOMES A CURRENT SHORTAGE , THE BOARD MAY RECONSIDER THE 19
PREVIOUSLY SET UPPER P AYMENT LIMIT. 20
(2) THE BOARD MAY NOT : 21
(I) ESTABLISH APPLY A NEW UPPER PAYMENT LIMIT FOR TO A 22
DRUG IN A CURRENT SHORTAGE ; 23
(II) ENFORCE AN UPPER PAYM ENT LIMIT AGAINST PR OVIDER 24
OR PHARMACY REIMBURS EMENT REQUIREMENTS F OR MEDICARE PART C OR PART 25
D PLANS; OR 26
(III) COUNT A PHARMACY DISP ENSING FEE TOWARD OR 27
SUBJECT A PHARMACY D ISPENSING FEE TO AN UPPER PAYMENT LIMIT . 28
10 HOUSE BILL 424
(d) (1) If a plan of action is drafted under subsection (a) of this section, the 1
Board shall submit the plan of action to the Legislative Policy Committee of the General 2
Assembly, in accordance with § 2–1257 of the State Government Article, for its approval. 3
(2) The Legislative Policy Committee shall have 45 days to approve the 4
plan of action. 5
(3) If the Legislative Policy Committee does not approve the plan of action, 6
the Board shall submit the plan to the Governor and the Attorney General for approval. 7
(4) The Governor and the Attorney General shall have 45 days to approve 8
the plan of action. 9
(5) The Board may not set upper payment limits unless the plan is 10
approved, in accordance with this subsection, by: 11
(i) The Legislative Policy Committee; or 12
(ii) 1. The Governor; and 13
2. The Attorney General. 14
21–2C–14. 15
[(a) If a plan of action is approved under § 21–2C–13(d) of this subtitle] IN 16
ACCORDANCE WITH THE PLAN OF ACTION APPRO VED BY THE LEGISLATIVE POLICY 17
COMMITTEE ON OCTOBER 22, 2024, the Board may set upper payment limits THROUGH 18
REGULATIONS for prescription drug products that are: 19
(1) Purchased or paid for by a unit of State or local government or an 20
organization on behalf of a unit of State or local government, including: 21
(i) State or county correctional facilities; 22
(ii) State hospitals; and 23
(iii) Health clinics at State institutions of higher education; 24
(2) Paid for through a health benefit plan on behalf of a unit of State or 25
local government, including a county, bicounty, or municipal employee health benefit plan; 26
or 27
(3) Purchased for or paid for by the Maryland State Medical Assistance 28
Program. 29
[(b) The upper payment limits set under subsection (a) of this section shall: 30 HOUSE BILL 424 11
(1) Be for prescription drug products that have led or will lead to an 1
affordability challenge; and 2
(2) Be set in accordance with the criteria established in regulations 3
adopted by the Board. 4
(c) (1) The Board shall: 5
(i) Monitor the availability of any prescription drug product for 6
which it sets an upper payment limit; and 7
(ii) If there becomes a shortage of the prescription drug product in 8
the State, reconsider whether the upper payment limit should be suspended or altered. 9
(2) An upper payment limit set under subsection (a) of this section may not 10
be applied to a prescription drug product while the prescription drug product is on the 11
federal Food and Drug Administration prescription drug shortage list.] 12
[21–2C–16. 13
On or before December 1, 2026, the Board, in consultation with the Stakeholder 14
Council, shall report to the Senate Finance Committee and the House Health and 15
Government Operations Committee, in accordance with § 2–1257 of the State Government 16
Article, on: 17
(1) The legality, obstacles, and benefits of setting upper payment limits on 18
all purchases and payor reimbursements of prescription drug products in the State; and 19
(2) Recommendations regarding whether the General Assembly should 20
pass legislation to expand the authority of the Board to set upper payment limits to all 21
purchases and payor reimbursements of prescription drug products in the State.] 22
21–2C–16. 23
(A) (1) THE BOARD, IN CONSULTATION WITH THE STAKEHOLDER 24
COUNCIL, SHALL DETERMINE WHET HER, IN ADDITION TO SETTI NG UPPER PAYMENT 25
LIMITS IN ACCORDANCE WITH § 21–2C–14 OF THIS SUBTITLE , IT IS IN THE BEST 26
INTEREST OF THE STATE FOR THE BOARD TO ESTABLISH A PROCESS FOR SETTING 27
UPPER PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR REIMBURSEMENTS OF 28
PRESCRIPTION DRUG PR ODUCTS IN THE STATE THAT THE BOARD DETERMINES 29
HAVE LED OR WILL LEA D TO AN AFFORDABILIT Y CHALLENGE . 30
(2) WHEN MAKING A DETERMI NATION UNDER PARAGRA PH (1) OF 31
THIS SUBSECTION , THE BOARD SHALL CONSIDER , IF APPLICABLE: 32 12 HOUSE BILL 424
(I) CONTRACT AND BUDGET D ATA PROVIDED TO THE BOARD 1
THAT DEMONSTRATES SA VINGS TO THE STATE OR LOCAL GOVERN MENTS AS A 2
RESULT OF UPPER PAYM ENT LIMITS SET IN AC CORDANCE WITH § 21–2C–14 OF THIS 3
SUBTITLE; 4
(II) SUCCESS OF SETTING UP PER PAYMENT LIMITS I N OTHER 5
STATES; AND 6
(III) EXPECTED SAVINGS FROM MEDICARE MAXIMUM FAIR 7
PRICES SET BY THE CENTERS FOR MEDICARE AND MEDICAID SERVICES. 8
(B) (1) IF THE BOARD MAKES AN AFFIRM ATIVE DETERMINATION UNDER 9
SUBSECTION (A) OF THIS SECTION , THE BOARD, IN CONSULTATION WITH THE 10
STAKEHOLDER COUNCIL, SHALL ESTABLISH A PR OCESS FOR SETTING UP PER 11
PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR REIMBURSEMENTS OF 12
PRESCRIPTION DRUG PR ODUCTS IN THE STATE THAT THE BOARD DETERMINES 13
HAVE LED OR WILL LEA D TO AN AFFORDABILIT Y CHALLENGE . 14
(2) THE PROCESS ESTABLISH ED UNDER PARAGRAPH (1) OF THIS 15
SUBSECTION SHALL : 16
(I) TO THE EXTENT APPROPR IATE, USE THE PLAN OF ACTI ON 17
APPROVED UNDER § 21–2C–13(D) OF THIS SUBTITLE; AND 18
(II) OTHERWISE COMPLY WITH THE REQUIREMENTS FOR 19
SETTING UPPER PAYMEN T LIMITS ESTABLISHED UNDER THIS SUBTITLE . 20
(3) BEFORE ESTABLISHING A N UPPER PAYMENT LIMI T THAT APPLIES 21
TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM, THE BOARD SHALL CONFER 22
WITH THE MARYLAND MEDICAL ASSISTANCE PROGRAM TO APPROVE TH E 23
APPLICATION OF THE U PPER PAYMENT LIMIT B Y ASSESSING WHETHER THE 24
PROPOSED UPPER PAYME NT LIMIT WILL: 25
(I) CONFLICT WITH THE MEDICAID DRUG REBATES 26
PROGRAM, THE COVERED OUTPATIENT DRUG RULE (CMS–2345–FC), OR ANY 27
OTHER FEDERAL REQUIR EMENTS AS APPLICABLE ; AND 28
(II) REQUIRE ADDITIONAL FU NDING TO BE ALLOCATE D TO THE 29
MARYLAND MEDICAL ASSISTANCE PROGRAM BUDGET . 30
SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 31
as follows: 32 HOUSE BILL 424 13
Article – Health – General 1
21–2C–16. 2
(C) (1) IF SUBJECT TO PARAGRAPH (2) OF THIS SUBSECTION , IF THE 3
BOARD ESTABLISHES A P ROCESS UNDER SUBSECT ION (B) OF THIS SECTION , THE 4
BOARD SHALL SET UPPER PAYMENT LIMITS FOR ALL PURCHASES AND PAYOR 5
REIMBURSEMENTS OF PR ESCRIPTION DRUG PROD UCTS IN THE STATE IN 6
ACCORDANCE WITH THE PROCESS. 7
(2) THIS SUBSECTION DOES NOT APPLY WITH RESPE CT TO: 8
(I) PAYOR REIMBURSEMENTS UNDER MEDICARE PART C AND 9
D PLANS; 10
(II) PURCHASES UNDER THE FEDERAL 340B DRUG PRICING 11
PROGRAM; AND 12
(III) PURCHASES AND PAYOR R EIMBURSEMENTS UNDER BY 13
FEDERAL AGENCIES OR FEDERAL PROGRAMS THA T ARE THE STATE IS PREEMPTED 14
FROM REGULATING BY FEDERAL LAW INCLUDING: 15
1. THE DEPARTMENT OF DEFENSE; 16
2. THE DEPARTMENT OF VETERANS AFFAIRS; 17
3. THE PUBLIC HEALTH SERVICE; 18
4. THE UNITED STATES COAST GUARD; 19
5. TRICARE; 20
6. THE FEDERAL EMPLOYEES HEALTH BENEFIT PLAN; 21
AND 22
7. ANY OTHER EXCLUSIVE F EDERAL PROGRAM AS 23
APPLICABLE. 24
SECTION 3. AND BE IT FURTHER ENACTED, That: 25
(a) Section 2 of this Act is contingent on the Prescription Drug Affordability Board 26
setting upper payment limits on two prescription drugs in accordance with § 21–2C–14 of 27 14 HOUSE BILL 424
the Health – General Article, as enacted by Section 1 of this Act, and each upper payment 1
limit being in effect for 1 year. 2
(b) Within 5 days after the conditions described in subsection (a) of this section 3
are met, the Prescription Drug Affordability Board shall notify the Department of 4
Legislative Services. 5
(c) If notice is received by the Department of Legislative Services in accordance 6
with subsection (b) of this section on or before September 31 September 30, 2030, Section 2 7
of this Act shall take effect on the date the notice is received by the Department of 8
Legislative Services. 9
(d) If notice is not received by the Department of Legislative Services on or before 10
December 31 September 30, 2030, Section 2 of this Act, with no further action required by 11
the General Assembly, shall be null and void. 12
SECTION 4. AND BE IT FURTHER ENACTED, That, subject to Section 3 of this 13
Act, this Act shall take effect October 1, 2025. 14
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.