.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Driver” means a factor that causes a particular phenomenon to happen or develop.

(2) “Eligible governmental entity” means a unit of State or local government, an organization on behalf of a unit of State or local government, or the Maryland State Medical Assistance Program, as identified in Health-General Article, §21-2C-14(a), Annotated Code of Maryland, that pays for or purchases prescription drug products.

(3) “Eligible governmental entities upper payment limit” or “GovUPL” means upper payment limit established by the Board minus applicable patient out-of-pocket costs.

(4) “FDA prescription drug shortage list” means the U.S. Food and Drug Administration’s Drug Shortage Database.

(5) “Medicaid Best Price” has the meaning stated in 42 CFR §447.505.

(6) “Medicare Maximum Fair Price” has the meaning stated in 42 USC §1320f(c)(3).

(7) “System net ingredient cost” means the final system cost attributable to or related to the prescription drug product after accounting for all discounts and price concessions, excluding dispensing, administration and direct and indirect remuneration to pharmacies, including patient out-of-pocket costs.

(8) “Upper payment limit” or “UPL” means the amount established by the Board and represents the system net ingredient cost.

C. For the purpose of this chapter, “affordability challenge” refers to either (a) high out-of-pocket costs for patients or (b) an affordability challenge for the State health care system.