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. *hb0571* HOUSE BILL 571 J1 3lr1931 CF SB 954 By: Delegate Kipke Delegates Kipke, Alston, Bagnall, Bhandari, Chisholm, Cullison, Guzzone, Hill, S. Johnson, Kaiser, Kerr, R. Lewis, Lopez, Martinez, M. Morgan, Pena–Melnyk, Rosenberg, Szeliga, Taveras, White, and Woods Introduced and read first time: February 3, 2023 Assigned to: Health and Government Operations Committee Report: Favorable with amendments House action: Adopted Read second time: March 5, 2023 CHAPTER ______ AN ACT concerning 1 Overdose Response Program – Opioid Overdose Reversal Drugs – Choice of 2 Formulation and Dosage 3 Opioids – Opioid Restitution Advisory Council and Fund and Overdose 4 Response Program 5 FOR the purpose of authorizing the Attorney General to direct that an Opioid Restitution 6 Fund Advisory Council committee be formed if required by a court or administrative 7 order or settlement agreement entered into by the Attorney General; requiring the 8 Maryland Department of Health to allow certain entities provided opioid overdose 9 reversal drugs by the Department under the Overdose Response Program to choose 10 the formulation or dosage of opioid overdose reversal drugs approved by the federal 11 Food and Drug Administration with which the entity is to be provided; applying the 12 requirement that the appropriation and distribution of funds in the Opioid 13 Restitution Fund that were received in accordance with certain opioid–related final 14 distributor and settlement agreements be made in a certain manner to funds 15 received in accordance with any opioid–related court or administrative judgment or 16 settlement agreement; and generally relating to the Overdose Response Program 17 opioids. 18 BY repealing and reenacting, with amendments, 19 Article – Health – General 20 Section 7.5–903(f), 7.5–904, and 13–3103 21 Annotated Code of Maryland 22 2 HOUSE BILL 571 (2019 Replacement Volume and 2022 Supplement) 1 BY repealing and reenacting, without amendments, 2 Article – State Finance and Procurement 3 Section 7–331(a) through (c) 4 Annotated Code of Maryland 5 (2021 Replacement Volume and 2022 Supplement) 6 BY repealing and reenacting, with amendments, 7 Article – State Finance and Procurement 8 Section 7–331(h) 9 Annotated Code of Maryland 10 (2021 Replacement Volume and 2022 Supplement) 11 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 12 That the Laws of Maryland read as follows: 13 Article – Health – General 14 7.5–903. 15 (f) [With] SUBJECT TO § 7.5–904(C) OF THIS SUBTITLE , WITH the consent of 16 the Council, the chair may designate additional individuals with relevant expertise to serve 17 on a committee of the Council in an advisory capacity. 18 7.5–904. 19 (a) (1) [The] SUBJECT TO SUBSECTION (C) OF THIS SECTION, THE Council 20 may adopt procedures necessary to do business, including the creation of committees. 21 (2) The Council may consult with State agencies to carry out the duties of 22 the Council. 23 (3) The Council shall meet at least four times a year. 24 (4) A majority of the voting members of the Council is a quorum. 25 (b) The Opioid Operational Command Center shall provide appropriate staff 26 necessary to support the functions of the Council. 27 (C) (1) IF REQUIRED BY A COUR T OR ADMINISTRATIVE ORDER OR A 28 SETTLEMENT AGREEMENT ENTERED INTO BY THE ATTORNEY GENERAL, THE 29 ATTORNEY GENERAL MAY DIRECT TH AT A COUNCIL COMMITTEE BE FORMED IN 30 ACCORDANCE WITH THE REQUIREMENTS OF THE COURT OR ADMINISTRAT IVE 31 ORDER OR SETTLEMENT AGREEMENT . 32 HOUSE BILL 571 3 (2) THE ATTORNEY GENERAL SHALL ESTABLI SH PROCEDURES FOR A 1 COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS SUBSECTION I N ORDER TO 2 ENSURE COMPLIANCE WI TH THE REQUIREMENTS OF THE COURT OR 3 ADMINISTRATIVE ORDER OR SETTLEMENT AGREEM ENT. 4 (3) (I) SUBJECT TO SUBPARAGRA PH (II) OF THIS PARAGRAPH , A 5 COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS SUBSECTION S HALL CONDUCT 6 ONLY BUSINESS RELATE D TO THE PURPOSE OF THE COURT OR ADMINIS TRATIVE 7 ORDER OR SETTLEMENT AGREEMENT THAT REQUI RED THE FORMATION OF THE 8 SUBCOMMITTEE . 9 (II) A COMMITTEE MAY CONDUC T BUSINESS RELATED T O 10 MULTIPLE CO URT OR ADMINISTRATIV E ORDERS OR SETTLEME NT AGREEMENTS IF 11 THE COURT OR ADMINIS TRATIVE ORDERS OR SE TTLEMENT AGREEMENTS CONTAIN 12 IDENTICAL REQUIREMEN TS. 13 (4) A COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS 14 SUBSECTION MAY CONSI ST ONLY OF MEMBERS O F THE COUNCIL. 15 (5) UNLESS OTHERWISE PROV IDED IN A COURT OR A DMINISTRATIVE 16 ORDER OR SETTLEMENT AGREEMENT , THE CHAIR OF THE COUNCIL, OR THE CHAIR’S 17 DESIGNEE, SHALL BE CHAIR OF A COMMITTEE FORMED UND ER PARAGRAPH (1) OF 18 THIS SUBSECTION . 19 13–3103. 20 (a) The Department shall adopt regulations necessary for the administration of 21 the Program. 22 (b) The Department may: 23 (1) Collect fees necessary for the administration of the Program; 24 (2) Authorize private or public entities to conduct education and training 25 on opioid overdose recognition and response that include: 26 (i) Education on recognizing the signs and symptoms of an opioid 27 overdose; 28 (ii) Training on responding to an opioid overdose, including the 29 administration of opioid overdose reversal drugs approved by the federal Food and Drug 30 Administration; and 31 4 HOUSE BILL 571 (iii) Access to opioid overdose reversal drugs approved by the federal 1 Food and Drug Administration and the necessary supplies for the administration of the 2 opioid overdose reversal drugs; 3 (3) Develop guidance regarding the content of educational training 4 programs conducted by private or public entities; and 5 (4) Collect and report data on the operation and results of the programs. 6 (c) An individual is not required to obtain training and education on opioid 7 overdose recognition and response from a private or public entity under subsection (b) of 8 this section in order for a pharmacist to dispense an opioid overdose reversal drug approved 9 by the federal Food and Drug Administration to the individual. 10 (d) (1) Subject to the limitations of the State budget, the Department shall 11 purchase and provide opioid overdose reversal drugs approved by the federal Food and 12 Drug Administration, at no cost, to the providers who are required to offer opioid overdose 13 reversal drugs approved by the federal Food and Drug Administration under § 8–408 or § 14 19–310.3 of this article. 15 (2) An entity required to offer an opioid overdose reversal drug approved 16 by the federal Food and Drug Administration under § 8–408 or § 19–310.3 of this article 17 may provide an opioid overdose reversal drug approved by the federal Food and Drug 18 Administration only if the opioid overdose reversal drug approved by the federal Food and 19 Drug Administration is provided by the Department. 20 (3) THE DEPARTMENT SHALL ALLO W AN ENTITY THAT IS PROVIDED 21 WITH OPIOID OVERDOSE REVERSAL DRUGS BY TH E DEPARTMENT UNDER THIS 22 SUBSECTION TO CHOOSE THE FORMULATION OR D OSAGE OF OPIOID OVER DOSE 23 REVERSAL DRUGS APPRO VED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION 24 WITH WHICH THE ENTITY IS TO BE PROVIDED. 25 Article – State Finance and Procurement 26 7–331. 27 (a) In this section, “Fund” means the Opioid Restitution Fund. 28 (b) There is an Opioid Restitution Fund. 29 (c) The purpose of the Fund is to retain the amount of settlement revenues 30 deposited to the Fund in accordance with subsection (e)(1) of this section. 31 (h) (1) Expenditures from the Fund may be made only in accordance with the 32 State budget. 33 HOUSE BILL 571 5 (2) For settlement funds received in accordance with the final distributor 1 agreement of July 21, 2021, with McKesson Corporation, Amerisource Bergen Corporation, 2 and Cardinal Health Incorporated, as amended, [or] the Janssen settlement agreement of 3 July 21, 2021, as amended, OR ANY OTHER OPIOID –RELATED COURT OR 4 ADMINISTRATIVE JUDGM ENT OR SETTLEMENT AG REEMENT INVOLVING TH E STATE 5 AND ONE OR MORE OF I TS POLITICAL SUBDIVI SIONS: 6 (i) appropriations from the Fund in the State budget shall be made 7 in accordance with the allocation and distribution of funds to the State and its political 8 subdivisions: 9 1. as agreed on in the State–subdivision agreement of 10 January 21, 2022, as amended; OR 11 2. REQUIRED UNDER ANY O THER OPIOID –RELATED 12 COURT OR ADMINISTRAT IVE JUDGMENT OR SETTLEMEN T AGREEMENT , OR ANY 13 SIMILAR AGREEMENT RE ACHED UNDER AN OPIOI D–RELATED COURT OR 14 ADMINISTRATIVE JUDGM ENT OR SETTLEMENT AG REEMENT, INVOLVING THE STATE 15 AND ONE OR MORE OF I TS POLITICAL SUBDIVI SIONS; and 16 (ii) the Secretary of Health shall establish and administer a grant 17 program for the distribution of funds to political subdivisions of the State in accordance 18 with: 19 1. the State–subdivision agreement of January 21, 2022, as 20 amended; OR 21 2. THE REQUIREMENTS OF ANY OTHER 22 OPIOID–RELATED COURT OR ADMIN ISTRATIVE JUDGMENT O R SETTLEMENT 23 AGREEMENT , OR ANY SIMILAR AGREE MENT REACHED UNDER A N OPIOID–RELATED 24 COURT OR ADMINISTRAT IVE JUDGMENT OR SETT LEMENT AGREEMENT , INVOLVING 25 THE STATE AND ONE OR MORE OF ITS POLITICAL SUB DIVISIONS. 26 (3) The Attorney General shall identify and designate the controlling 27 version of any agreement or amendment described under paragraph (2) of this subsection. 28 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 29 October July 1, 2023. 30