(a) In this subtitle the following words have the meanings indicated. (b) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502. (c) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3). (d) “Board” […]
(a) (1) There is a Prescription Drug Affordability Board. (2) (i) The Board is a body politic and corporate and is an instrumentality of the State. (ii) The Board is an independent unit of State government. (iii) The exercise by the Board of its authority under this subtitle is an essential governmental function. (b) The purpose of the Board is to protect […]
(a) (1) The Board consists of the following members, who must have expertise in health care economics or clinical medicine: (i) One member appointed by the Governor; (ii) One member appointed by the President of the Senate; (iii) One member appointed by the Speaker of the House of Delegates; (iv) One member appointed by the Attorney General; and (v) One member appointed […]
(a) There is a Prescription Drug Affordability Stakeholder Council. (b) The purpose of the Stakeholder Council is to provide stakeholder input to assist the Board in making decisions as required under this subtitle. (c) (1) The Stakeholder Council consists of 26 members appointed in accordance with this subsection. (2) The Speaker of the House of Delegates shall appoint: (i) One representative […]
(a) (1) A conflict of interest shall be disclosed: (i) By the Board when hiring Board staff; (ii) By the appointing authority when appointing members and alternate members to the Board and members to the Stakeholder Council; and (iii) By the Board, when a member of the Board is recused in any final decision resulting from a review of a […]
Members and alternate members of the Board, Board staff, and third–party contractors may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the Board.
On or before December 31, 2021, the Board, in consultation with the Stakeholder Council, shall: (1) Study: (i) The entire pharmaceutical distribution and payment system in the State; and (ii) Policy options being used in other states and countries to lower the list price of pharmaceuticals, including: 1. Setting upper payment limits; 2. Using a reverse auction marketplace; and 3. Implementing […]
(a) On or before December 31, 2021, the Board shall: (1) Collect and review publicly available information regarding prescription drug product manufacturers, health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers; and (2) (i) Identify states that require reporting on the cost of prescription drug products; and (ii) Initiate a process of entering into […]
(a) (1) After identifying prescription drug products as required by § 21–2C–08 of this subtitle, the Board shall determine whether to conduct a cost review as described in subsection (b) of this section for each identified prescription drug product by: (i) Seeking Stakeholder Council input about the prescription drug product; and (ii) Considering the average cost share of the […]
(a) All information and data obtained by the Board under this subtitle, that is not otherwise publicly available: (1) Is considered to be a trade secret and confidential and proprietary information; and (2) Is not subject to disclosure under the Public Information Act. (b) Only Board members and staff may access trade secrets and confidential and proprietary data and […]
(a) In this section, “Fund” means the Prescription Drug Affordability Fund. (b) (1) The Board shall assess and collect an annual fee on: (i) Manufacturers that sell or offer for sale prescription drug products to persons in the State; (ii) Pharmacy benefits managers, as defined in § 15–1601 of the Insurance Article; (iii) Carriers, as defined in § 19–132 of this […]
The Office of the Attorney General may pursue any available remedy under State law when enforcing this subtitle.
(a) On or after January 1, 2022, the Board may set upper payment limits for prescription drug products that are: (1) Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State or local government, including: (i) State or county correctional facilities; (ii) State hospitals; and (iii) Health clinics […]
(a) On or after January 1, 2022, the Board, in accordance with the plan of action approved under § 21–2C–13 of this subtitle, may set upper payment limits for prescription drug products that are: (1) Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State […]
(a) A person aggrieved by a decision of the Board may request an appeal of the decision within 30 days after the finding of the Board. (b) The Board shall hear the appeal and make a final decision within 60 days after the appeal is requested. (c) Any person aggrieved by a final decision of the Board may […]
On or before December 1, 2023, the Board, in consultation with the Stakeholder Council, shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, on: (1) The legality, obstacles, and benefits of setting upper payment limits on all purchases and payor […]
