1. (a) If, under § 21-2C-07 of this subtitle, the Board finds that it is in the best interest of the State to establish a process for setting upper payment limits for prescription drug products that it determines have led or will lead to an affordability challenge, the Board, in conjunction with the Stakeholder Council, shall draft a plan of action for implementing the process in accordance with the requirements of this section.

2. (b) The criteria for setting upper payment limits shall include consideration of:

   1. (1) The cost of administering the prescription drug product;
   2. (2) The cost of delivering the prescription drug product to consumers;
   3. (3) The effect the upper payment limit will have on providers of 340B drugs;
   4. (4) For an upper payment limit on a drug that is designated as a drug for a rare disease or condition, the impact of the upper payment limit on patients with rare diseases; and
   5. (5) Other relevant administrative costs related to the prescription drug product.

3. (c)

   1. (1) If the Board previously set an upper payment limit for a drug that becomes a current shortage, the Board may reconsider the previously set upper payment limit.

   2. (2) The Board may not:

      1. (i) Apply a new upper payment limit to a drug in a current shortage;
      2. (ii) Enforce an upper payment limit against provider or pharmacy reimbursement requirements for Medicare Part C or Part D plans; or
      3. (iii) Count a pharmacy dispensing fee toward or subject a pharmacy dispensing fee to an upper payment limit.

4. (d)

   1. (1) If a plan of action is drafted under subsection (a) of this section, the Board shall submit the plan of action to the Legislative Policy Committee of the General Assembly, in accordance with § 2-1257 of the State Government Article, for its approval.
   2. (2) The Legislative Policy Committee shall have 45 days to approve the plan of action.
   3. (3) If the Legislative Policy Committee does not approve the plan of action, the Board shall submit the plan to the Governor and the Attorney General for approval.
   4. (4) The Governor and the Attorney General shall have 45 days to approve the plan of action.

   5. (5) The Board may not set upper payment limits unless the plan is approved, in accordance with this subsection, by:

      1. (i) The Legislative Policy Committee; or

      2. (ii) 1. The Governor; and

         1. 2. The Attorney General.

Added by Acts 2023, c. 39 § 1, eff. April 11, 2023; Acts 2023, c. 40, § 1, eff. April 11, 2023. Amended by Acts 2025, c. 610, § 1, eff. Oct. 1, 2025; Acts 2025, c. 611, § 1, eff. Oct. 1, 2025.