1. A. When developing preliminary policy recommendations for the Board, Board staff may use information gathered or obtained through the:

   1. (1) Cost review study process under COMAR 14.01.04; and
   2. (2) Information gathering process under Regulation .04 of this chapter.

2. B. Policy Action Other than UPL.

   1. (1) Board staff may recommend policy options to redress the affordability challenge.

   2. (2) When recommending policy options, Board staff may analyze the:

      1. (a) Drivers of the affordability challenge;
      2. (b) How the policy addresses a driver;
      3. (c) Strengths and weaknesses of the policy;
      4. (d) Possible implementation of the policy through legislation, regulation, or enforcement; and
      5. (e) Potential impacts of the policy.

   3. (3) The Board may:

      1. (a) Adopt none of the non-UPL policy recommendations;
      2. (b) Adopt one or more policy recommendations; or
      3. (c) Adopt and modify one or more policy recommendations.

   4. (4) The Board may adopt a final policy recommendation only after the Board has:

      1. (a) Made a final affordability challenge determination; and
      2. (b) Adopted the final cost review study report under COMAR 14.01.04.05G.
   5. (5) 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. C. Policy Action in the Form of an Upper Payment Limit.

   1. (1) Board staff may recommend a UPL as a policy option to redress an affordability challenge.

   2. (2) When recommending a UPL as a policy option, Board staff may analyze the:

      1. (a) The drivers and market conditions causing the affordability challenge phenomena;
      2. (b) Ability of a UPL to address these issues;
      3. (c) Strengths and weaknesses of the UPL policy;
      4. (d) Potential impacts of the UPL policy;
      5. (e) Possible implementation of the policy through legislation, regulation or enforcement;
      6. (f) Relevant regulatory criteria under Regulation .02 of this chapter; and
      7. (g) Use of the drug by eligible governmental entities.

   3. (3) Board staff may provide recommendations related to establishing a UPL including:

      1. (a) An assessment of the drivers of the affordability challenge; and
      2. (b) The extent to which a UPL may address the drivers.
   4. (4) The Board may pursue development of a UPL as a policy option and direct Board staff to provide recommendations concerning the frameworks and contextual information that may be used to set a UPL in accordance with the UPL process set forth in Regulation .06 of this chapter.
   5. (5) 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).

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