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.
