1. A. Authority to Reconsider UPL.

   1. (1) The Board may reconsider a UPL for any reason.
   2. (2) If the Board becomes aware of a shortage of a prescription drug product in the State, for a drug that is subject to a UPL, the Board shall reconsider the UPL.
   3. (3) The Board may suspend a UPL at any time and may suspend the UPL for the duration of the reconsideration process by proposing an amended regulation.

   4. (4) Following completion of the reconsideration process the Board may:

      1. (a) Take no action and allow the UPL to stand;
      2. (b) Modify the UPL amount and propose amendment of the UPL regulation setting the new modified UPL amount;
      3. (c) Suspend the UPL for a specified period and propose amendment of the regulation to proscribe the suspension; and
      4. (d) Repeal the UPL and propose repealing the regulation setting the UPL amount.

2. B. Reconsideration Process.

   1. (1) General Procedures.

      1. (a) Board staff shall post notice of the reconsideration of the UPL on the Board’s website.
      2. (b) The Board may solicit patient and stakeholder feedback through written comments submitted in accordance with COMAR 14.01.01.05B(4) and informational hearings held under COMAR 14.01.01.06C.
      3. (c) The Board may use the information gathering process under Regulation .04 of this chapter to obtain information for the reconsideration process.

      4. (d) Board staff shall present to the Board:

         1. (i) The basis for reconsideration;
         2. (ii) A summary of the feedback obtained through written comments, informational hearings and the information gathering process, as applicable;
         3. (iii) A summary of the information generated through the UPL monitoring program, as applicable;
         4. (iv) Estimated impact of the UPL to date such as savings estimates, and estimated impact on access to the drug; and
         5. (v) Staff recommendations for Board action.
      5. (e) The Board may take any action specified under §A(4) of this regulation.

   2. (2) Modifying a UPL.

      1. (a) If Board staff recommends further study to support modification of the UPL, the Board shall use the procedures in Regulations .06D-F and .07B(1)(b) of this chapter to develop a new UPL amount and receive public comment.
      2. (b) The Board may modify the UPL amount and propose amendment of the UPL regulation setting the modified UPL amount under § A(4)(b) of this regulation.

3. C. Action on Drug where UPL was Repealed.

   1. (1) For any prescription drug product previously subject to a UPL that was later repealed, the Board may:

      1. (a) Select the prescription drug product for cost review study if the drug product meets the eligibility requirements set forth in COMAR 14.01.04.02;
      2. (b) Conduct a cost review study in accordance with COMAR 14.01.04.05; and
      3. (c) Make a preliminary determination in accordance with COMAR 14.01.04.05.

   2. (2) If the Board makes a preliminary determination that the prescription drug product has or will create an affordability challenge the Board may:

      1. (a) Consider any element or analysis from the original cost review study report;
      2. (b) If available, consider information from the UPL monitoring program;
      3. (c) Consider information obtained through the reconsideration process under §B of this regulation; and
      4. (d) Set a UPL or make other policy recommendations in accordance with Regulations .07—.08 of this chapter.

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