.04 Policy Review—Information Gathering.

A. In studying the drivers, market conditions and policy options, the Board and staff may consider the information collected through the cost review study process pursuant to Health-General Article, §21-2C-09, Annotated Code of Maryland and COMAR 14.01.04.05, including all information, analyses, and public input collected and considered during the selection of drug for the cost review study and the cost review study process.

B. If additional information is needed, the Board and staff may gather additional information through the tools outlined in §D of this regulation.

C. If additional information is needed, the Board may utilize the information-gathering tools outlined in §D of this regulation at any point in the policy review process, including the consideration and setting of a UPL.

D. Information Gathering Tools.

(1) Public Informational Hearings.

(a) The Board may, through Board staff, convene a hearing to receive input, information, and opinions from the public and stakeholders to inform the consideration and development of policy options including upper payment limits to redress an affordability challenge.

(b) The public informational hearing shall be conducted in accordance with COMAR 14.01.01.06.

(2) Stakeholder Council Input.

(a) The Board may request input from the Stakeholder Council. This input can be a request for general input and ideas on policies or more specific requests for specific information.

(b) Board staff may provide the Board with summaries of input from the Stakeholder Council.

(3) Technical Hearings.

(a) The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony.

(b) The technical hearing shall be conducted in accordance with COMAR 14.01.01.06.

(4) Board Staff Research and Analysis.

(a) Board staff may provide the Board with policy research and analyses related to the drivers of the potential affordability and potential options.

(b) Research may include a literature review of available literature and original quantitative or qualitative research conducted by staff.

(5) Eligible Governmental Entities’ Information.

(a) Board staff may collect information concerning the prescription drug product and therapeutic alternatives from eligible governmental entities.

(b) The information collected may include utilization, spending, costs, benefit design, formulary placement, rebates, discounts, price concessions and other relevant information.