Pennsylvania Code › Title 55 - HUMAN SERVICES › Part III - MEDICAL ASSISTANCE MANUAL › Chapter 1121 - PHARMACEUTICAL SERVICES › GENERAL PROVISIONS › Section 1121.2 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following words and terms, when used in this chapter,
					 have the following meanings, unless the context clearly indicates
					 otherwise:
AWP
-The average wholesale price for a drug
					 as found in the Department's pricing service publication.
Brand name
-A registered trade name
					 commonly used to identify a drug.
CMS
-The Centers for Medicare and Medicaid
					 Services.
CMS multisource drug
-A multisource drug
					 identified by CMS for which FFP is limited under
					 42 CFR
					 447.331 -
					 447.333 (relating to drugs:
					 aggregate upper limits of payment; upper limits for multiple source drugs;
					 state plan requirements, findings and assurances).
Compounded prescription
-A prescription
					 that is prepared in the pharmacy by combining two or more ingredients and
					 involves the weighing of at least one solid ingredient which shall be a
					 compensable item or a legend drug in a therapeutic amount.
DESI drug
-A drug product for which Federal
					 Financial Participation FFP is not available under
					 42 CFR
					 441.25 (relating to less than effective
					 drugs).
EAC-Estimated Acquisition Cost
-As defined
					 in 42 CFR
					 447.301 (relating to definitions).
Experimental drug
-A drug or product
					 currently being investigated under licensure by the FDA to determine its safety
					 and effectiveness.
FDA
-Food and Drug Administration.
FFP-Federal financial
					 participation.
Federal upper limit
-The per unit amount
					 set for a multisource drug which is established by CMS under
					 42 CFR
					 447.332.
Generic drug
-A drug that is "A-rated" by
					 the FDA as therapeutically equivalent to the counterpart brand name
					 drug.
Legend drug
-A drug or product that under
					 Federal law or State law can be dispensed only upon the order of a
					 physician.
Licensed prescriber
-A person currently
					 licensed under the law of a state to order medication.
Multisource drug
-A drug marketed or sold
					 by two or more manufacturers or labelers or a drug marketed or sold by the same
					 manufacturer or labeler under two or more different proprietary names or both
					 under a proprietary name and without such a name.
Nonlegend drug
-A drug or product that can
					 be purchased without a prescription.
OBRA '90
-The Omnibus Budget Reconciliation
					 Act of 1990 (Pub. L. No.
					 101-508, 104 Stat. 1388).
Pricing service
-A third-party source that
					 compiles and provides drug-specific information needed to maintain the drug
					 refernece file under this chapter.
State MAC
-The maximum allowable cost
					 established for a multisource drug.
Usual and customary charge
-The pharmacy's
					 lowest net charge an MA recipient would pay for a prescription as a
					 non-Medicaid patient at the time of dispensing for the same quantity and
					 strength of a particular drug or product, including applicable discounts, such
					 as special rates to nursing home residents, senior citizens, or other discounts
					 extended to a particular group of patients, including generic drug discount and
					 savings programs. This lowest net price does not apply to special in-store
					 rates or discounts extended to charitable organizations, religious groups,
					 store employees and their families, nonprofit organizations, members of the
					 medical profession or other similar non-Medicaid groups.
WAC-Wholesale Acquisition Cost
-The
					 manufacturer's list price for a drug to wholesalers or direct purchasers in the
					 United States as listed in one or more available Nationally recognized pricing
					 services.
This regulation was promulgated under section 6(b) of the
						Regulatory Review Act (71 P. S. §
													745.6(b)).
The provisions of this §
												1121.2 amended under sections
						201(2), 403(b), 403.1, 443.4 and 454 of the Public Welfare Code (62 P. S.
						§§
													201(2),
						403(b), 403.1, 443.4 and
						454).