Section 22.2. Definitions

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.

The provisions of this § 22.2 adopted June 15, 1984, effective June 16, 1984, 14 Pa.B. 2109; corrected July 6, 1984, effective June 16, 1984, 14 Pa.B. 2331; amended March 29, 1985, effective March 30, 1985, 15 Pa.B. 1163; corrected April 12, 1985, effective March 30, 1985, 15 Pa.B. 1353; amended December 13, 1985, effective December 14, 1985, 15 Pa.B. 4427; amended December 14, 1990, effective December 15, 1990, 20 Pa.B. 6143. Immediately preceding text appears at serial pages (91333) to (91334) and (103119) to (103120).

Notation

Cross References

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).