Section 21-2C-08 – Collection, Review, and Use of Transparency Data for Prescription Drug Products
(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 […]
Section 21-2C-09 – Cost Review of Prescription Drug Products With Affordability Challenges
(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 […]
Section 21-2C-10 – Confidentiality
(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 […]
Section 21-2C-11 – Funding Source
(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 […]
Section 21-2C-12 – Enforcement
The Office of the Attorney General may pursue any available remedy under State law when enforcing this subtitle.
Section 21-2C-13 – Drafting Action Plan for Implementing Process to Set Upper Payment Limits for Prescription Drug Products
(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 […]
Section 21-2C-14 – Setting Upper Payment Limits for Prescription Drug Products
(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 […]
Section 21-2C-15 – Appeals of Board Decisions
(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 […]
Section 21-2C-16 – Board and Stakeholder Council Report and Recommendation Concerning Upper Payment Limits
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 […]
Section 21-2C-01 – Definitions
(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” […]