1. A. Final Determination Concerning Affordability Challenge.

   1. (1) Prior to taking an action with respect to policy, the Board shall:

      1. (a) Make a final determination of whether the prescription drug has or will create an affordability challenge; and
      2. (b) Adopt as final a cost review study report under COMAR 14.01.04.05G.
   2. (2) The Board’s determination of whether a prescription drug has or will create an affordability challenge is not final until the final cost review study report is adopted by the Board.
   3. (3) The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2).

2. B. Final Policy Action: Policy Recommendations and Proposed Regulations.

   1. (1) If the Board makes a final determination that the prescription drug has or will create an affordability challenge, the Board may adopt:

      1. (a) Non-UPL policy recommendations in accordance with Regulation .05 of this chapter;
      2. (b) Proposed regulations setting the UPL at the specified amount in accordance with Regulation .08 of this chapter; or
      3. (c) Both.
   2. (2) The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2).

   3. (3) Where applicable, the adoption of the final cost review study report, non-UPL policy recommendations, and proposed regulations setting a UPL amount:

      1. (a) Shall be performed sequentially; and
      2. (b) May be taken at the same Board meeting.

Effective date: April 28, 2025 (52:8 Md. R. 359)