Section 590-340-1 - DefinitionsUnless the context indicates otherwise, the following words and phrases shall have the following meanings:
A.340B Drug Program. "340B Drug Program" means Section 340B of the Public Health Service Act that requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low- income patients. These organizations include federal grantee organizations and several types of hospitals, including critical access hospitals (CAHs), sole community hospitals (SCHs), rural referral centers (RRCs), and public and nonprofit disproportionate share hospitals (DSH) that serve low-income and indigent populations.B.340B Acquisition Cost. "340B Acquisition Cost" means the cost to the hospital and, where applicable, its Contract Pharmacies and 340B Third Party Administrators, to purchase a prescription drug product with a unique NDC under the 340B Drug Program.C.340B Third Party Administrator. "340B Third Party Administrator" means an entity contracted by a Hospital to administer tasks related to purchasing, inventory management, reporting, billing, or other administration for its 340B Drug Program.D.Contract Pharmacy. "Contract Pharmacy" means a pharmacy contracted by a Hospital to dispense 340B drugs to patients, that is registered for the 340B Drug Program, and listed as active on the 340B Office of Pharmacy Affairs Information System (OPAIS), whether or not such pharmacy is located in the State.E.Hospital. "Hospital" means an acute care institution licensed and operating in this State as a hospital under section 1811 or the parent of such institution; or a hospital subsidiary or hospital affiliate in the State that provides medical services or medically related diagnostic and laboratory services or engages in ancillary activities supporting those services.F.MHDO. "MHDO" means the Maine Health Data Organization.G.M.R.S. "M.R.S." means Maine Revised Statutes.H.National Drug Code (NDC). "National Drug Code" means the three-segment code maintained by the federal Food and Drug Administration that includes a labeler code, a product code, and a package code for a drug product and that has been converted to an 11-digit format consisting of five digits in the first segment, four digits in the second segment, and two digits in the third segment. A three-segment code shall be considered converted to an 11-digit format when, as necessary, at least one "0" has been added to the front of each segment containing less than the specified number of digits such that each segment contains the specified number of digits.90-590 C.M.R. ch. 340, § 1