§ 21-2C-13

(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.

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

(1) The cost of administering the prescription drug product;

(2) The cost of delivering the prescription drug product to consumers;

(3) The effect the upper payment limit will have on providers of 340B drugs;

(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) Other relevant administrative costs related to the prescription drug product.

(c) (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) The Board may not:

(i) Apply a new upper payment limit to a drug in a current shortage;

(ii) Enforce an upper payment limit against provider or pharmacy reimbursement requirements for Medicare Part C or Part D plans; or

(iii) Count a pharmacy dispensing fee toward or subject a pharmacy dispensing fee to an upper payment limit.

(d) (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) The Legislative Policy Committee shall have 45 days to approve the plan of action.

(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) The Governor and the Attorney General shall have 45 days to approve the plan of action.

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

(i) The Legislative Policy Committee; or

(ii) 1. The Governor; and

2. The Attorney General.

§21–2C–13. ** CONTINGENCY – NOT IN EFFECT – CHAPTER 692 OF 2019 **

(a) On or after January 1, 2022, the Board may set upper payment limits for prescription drug products that are:

(1) Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State or local government, including:

(i) State or county correctional facilities;

(ii) State hospitals; and

(iii) Health clinics at State institutions of higher education;

(2) Paid for through a health benefit plan on behalf of a unit of State or local government, including a county, bicounty, or municipal employee health benefit plan; or

(3) Purchased for or paid for by the Maryland State Medical Assistance Program.

(b) The upper payment limits set under subsection (a) of this section shall:

(1) Be for prescription drug products that have led or will lead to an affordability challenge; and

(2) Be set in accordance with the criteria established in regulations adopted by the Board.

(c) (1) The Board shall:

(i) Monitor the availability of any prescription drug product for which it sets an upper payment limit; and

(ii) If there becomes a shortage of the prescription drug product in the State, reconsider whether the upper payment limit should be suspended or altered.

(2) An upper payment limit set under subsection (a) of this section may not be applied to a prescription drug product while the prescription drug product is on the federal Food and Drug Administration prescription drug shortage list.