§ 21-2C-09. Cost review of prescription drug products identified in § 21-2C-08
West's Annotated Code of MarylandHealth--GeneralEffective: July 1, 2019
Effective: July 1, 2019
MD Code, Health - General, § 21-2C-09
§ 21-2C-09. Cost review of prescription drug products identified in § 21-2C-08
(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:
(ii) The information to conduct a cost review may include any document and research related to the manufacturer's selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in the State, market competition and context, projected revenue, and the estimated value or cost-effectiveness of the prescription drug product.
(iii) Failure of a manufacturer, wholesale distributor, pharmacy benefits manager, health insurance carrier, health maintenance organization, or managed care organization to provide the Board with the information requested under this paragraph does not affect the authority of the Board to conduct a review as described in subsection (b) of this section.
(b)(1) If the Board conducts a review of the cost of a prescription drug product, the review shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the United States Food and Drug Administration or standard medical practice has led or will lead to affordability challenges for the State health care system or high out-of-pocket costs for patients.
(ii) The average monetary price concession, discount, or rebate the manufacturer provides to health plans in the State or is expected to provide to health plans in the State as reported by manufacturers and health plans, expressed as a percent of the wholesale acquisition cost for the prescription drug product under review;
(iii) The total amount of the price concession, discount, or rebate the manufacturer provides to each pharmacy benefits manager operating in the State for the prescription drug product under review, as reported by manufacturers and pharmacy benefits managers, expressed as a percent of the wholesale acquisition costs;
(ii) The portion of direct-to-consumer marketing costs eligible for favorable federal tax treatment in the most recent tax year that are specific to the prescription drug product under review and that are multiplied by the ratio of total manufacturer in-State sales to total manufacturer sales in the United States for the product under review;
(c) On or before December 31, 2020, and each December 31 thereafter, the Board shall submit to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2-1257 of the State Government Article, a report that includes:
Credits
Added by Acts 2019, c. 692, § 1, eff. July 1, 2019. Amended by Acts 2019, c. 510, § 4; Acts 2019, c. 511, § 4.
MD Code, Health - General, § 21-2C-09, MD HEALTH GEN § 21-2C-09
Current through legislation effective through April 9, 2023, from the 2024 Regular Session of the General Assembly. Some statute sections may be more current, see credits for details.
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