Pennsylvania Code › Title 6 - AGING › Part I - Department of Aging › Chapter 22 - PHARMACEUTICAL ASSISTANCE CONTRACT FOR THE ELDERLY › GENERAL PROVISIONS › Section 22.2 - 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:
Act
-The Pharmaceutical Assistance
					 Contract for the Elderly Act (62 P. S. §§
											2901-2908).
Acute condition
-A short-term medical
					 condition or ailment for which the normal and typically recommended drug
					 therapy does not exceed 15 days.
Applicant
-A person who applies to
					 participate in the PACE Program, either personally or through an authorized
					 agent.
Application
-The form completed and
					 submitted to the Department by an applicant which is used by the Department to
					 determine that applicant's eligibility to participate in the PACE Program.
					 Also, the form completed and submitted to the Department by a claimant which is
					 used by the Department to redetermine that claimant's eligibility to
					 participate in the PACE Program.
Average wholesale cost
-The cost of a
					 dispensed drug based upon the price published in a national drug pricing system
					 in current use by the Department as the average wholesale price of a
					 prescription drug in the most common package size. The terms "average wholesale
					 cost" and "average wholesale price" are synonymous.
Claim
-In the case of a claimant,
					 presentation to an enrolled provider of a valid PACE identification card in
					 order to receive prescription drugs. In the case of an enrolled provider, a
					 request to the Department for payment for providing prescription drugs under
					 the PACE Program.
Claimant
-A resident of this Commonwealth
					 who meets the conditions specified in §§
										22.21-22.26 (relating to claimant
					 eligibility) and whose application for enrollment in the PACE Program has been
					 approved by the Department.
Contractor
-The person, partnership or
					 corporate entity which has an approved contract with the Department to
					 administer the pharmaceutical assistance program as established under the act
					 and this chapter.
Copayment
-The dollar amount which is
					 required under the program to be paid to enrolled providers by claimants for
					 each prescription.
DESI (Drug Efficacy Study Implementation)
					 drug
-Drug products introduced into the market as new drugs from
					 1938-1962 which were submitted for review by the National Academy of
					 Sciences-National Research Council Drug Efficacy Study Group and are still
					 considered by the Food and Drug Administration as less than effective in
					 meeting their manufacturers' claims. The term includes identical, related or
					 similar products as covered under
					 21 CFR
					 310.6 (relating to applicability of "new
					 drug" or safety or effectiveness findings in drug efficacy study implementation
					 notices and notices of opportunity for hearing to identical, related, and
					 similar drug products). The term includes the same drug products considered not
					 reimbursable by the Medical Assistance Program under
					 42 CFR
					 441.25 (relating to prohibition on FFP for
					 certain prescribed drugs).
Department
-The Department of Aging of the
					 Commonwealth, its authorized agent or the contractor.
Dispensing
-Under the PACE Program, the
					 preparation of a prescription drug by a PACE provider, the delivery of the
					 prepared prescription drug to a PACE claimant and the collection from the PACE
					 claimant of the required copayment.
Dispensing fee
-The dollar amount paid to
					 the participating pharmacy by the program for filling prescriptions approved
					 under the PACE Program.
Dispensing physician
-A medical doctor or
					 osteopathic doctor currently licensed by the Commonwealth who dispenses
					 prescription drugs.
Enrolled provider
-A pharmacy or
					 dispensing physician that meets the conditions of eligibility and participation
					 in §§
										22.61 and
					 22.62 (relating to conditions of
					 provider eligibility; and conditions of provider participation).
Experimental drug
-A drug currently being
					 administered under an investigational new drug application as required by the
					 United States Food and Drug Administration (FDA) under 21 CFR Part 312
					 (relating to new drugs for investigational use) to determine its safety and
					 effectiveness.
Generically equivalent drugs
-Prescription
					 drug products, including those sold under brand names, having the same generic
					 name, dosage form and labeled potency, listed in the Formulary of Generically
					 Equivalent Drug Products at 28 Pa. Code §
										25.58 (relating to generically
					 equivalent drug products).
Generic differential
-A percentage of the
					 average wholesale cost of a brand name prescription drug as provided under
					 §
										22.11(g) (relating
					 to general payment principles). The percentage is the same for all applicable
					 transactions. This percentage is established by the Department as specified
					 under § 22.11(g)(3).
Income
-All income from whatever source
					 derived, as specified in §
										22.24 (relating to income
					 provisions).
Mail
-First class mail under the
					 regulations of the United States Postal Service or common carrier, able to
					 assure delivery within 5 calendar days.
Medical Assistance Program
-The Federal
					 Medicaid program as administered under 55 Pa. Code Part III (relating to
					 Medical Assistance Manual).
Medicare
-The Federal program which
					 provides medical care under Title XVIII of the Social Security Act
					 (42 U.S.C.A. §§
											1395-1395xx).
Medication history
-A pharmacy medication
					 record established and maintained on each PACE claimant served by the pharmacy.
					 This record shall include, as a minimum, the following claimant information as
					 obtained from the claimant or equivalent information as approved by the
					 Department:
(i) Name.
(ii) PACE identification card
				  number.
(iii) Medication allergies
				  and other allergies.
(iv) Current
				  medication utilization.
(v)
				  Indication of all medical disorders known to the claimant.
(vi) Separate entries for each prescription
				  medication dispensed by the provider.
Most common package size
-A prescription
					 drug package size identified in one of the following descriptions as the size
					 most commonly purchased by enrolled providers:
(i) The package size listed in the February
				  1984 "Yellow Book" distributed by the United States Health Care Financing
				  Administration (HCFA) for drugs contained on that list.
(ii) Changes or additions to the package
				  sizes listed in the February 1984 "Yellow Book" established by the Department
				  with the approval of the Pharmaceutical Assistance Review Board and published
				  in the
Pennsylvania Bulletin.
National drug pricing system
-A published
					 data information system which includes listings of average wholesale prices and
					 direct prices of prescription drugs such as "The Drug Topics Red Book,"
					 Medi-Span, Inc. or "Prescription Pricing Guide."
PACE
-The Pennsylvania Pharmaceutical
					 Assistance Contract for the Elderly Program.
Pharmaceutical Assistance Review
					 Board
-The Board established by the act in order to help ensure the
					 continuing efficiency and effectiveness of the PACE Program.
Pharmacy
-A pharmacy currently licensed by
					 the Commonwealth.
Prescriber
-A physician or other health
					 practitioner licensed by the Commonwealth to prescribe drugs or a physician
					 authorized by the Department under § 22.11(f)(9).
Prescription drugs
or
drugs
-Drugs requiring a prescription in this Commonwealth, and
					 insulin, insulin syringes and insulin needles. The term does not include
					 experimental drugs, DESI drugs and drugs not approved by the Department of
					 Health for use in this Commonwealth.
Principal place of business
-A location in
					 this Commonwealth where an enrolled provider can and will conduct all business
					 directly related to the dispensing of prescription drugs under the PACE
					 Program.
Resident
-A person who has lived within
					 this Commonwealth for a period of at least 90 consecutive days and who meets
					 the conditions as set forth in §
										22.22 (relating to residence
					 provisions).
Secretary
-The Secretary of the
					 Department.
Unit
-The measured quantity of a
					 prescription drug to be used such as a single tablet or capsule. The term only
					 includes drugs dispensed in tablet or capsule form.
Universal Claim Form
-The standard form,
					 copyrighted by the National Council of Prescription Drug Programs, and in
					 current usage by pharmacies to document for third-party payors prescription
					 services provided by claimants eligible for prescription benefits under a plan
					 administered by a third-party payor. Current usage connotes the most current
					 official version of this form in use at this time and at any given time in the
					 future.
Usual charge
-An enrolled provider's
					 charge to the cash-paying public for a prescription drug, in a specific
					 strength and quantity within a specific calendar month. Discounts or coupons
					 offered to the cash-paying public shall be considered to be offered to the
					 Commonwealth as well. Discounts applicable to claimants or coupons presented by
					 claimants shall be accepted by the provider and credited to the PACE Program
					 payment and not the copayment or, if applicable, the generic
					 differential.
This section cited in 6 Pa. Code §
												22.11 (relating to general payment
						principles); 6 Pa. Code §
												22.24 (relating to income
						provisions); 6 Pa. Code §
												22.33 (relating to responsibilities
						of the applicant in the application process); and 6 Pa. Code §
												22.42 (relating to responsibilities
						of the claimant in the eligibility redetermination
						process).