40 Pa. Stat. § 4503

Current through Pa Acts 2024-53, 2024-56 through 2024-111
Section 4503 - Definitions

The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise:

"Affiliate" or "affiliated." An "affiliate" as defined in section 1401 of the act of May 17, 1921 (P.L.682, No.284), known as the Insurance Company Law of 1921.

"Auditing entity." A person or company that performs a pharmacy audit, including a covered entity, pharmacy benefit manager, managed care organization or third-party administrator.

"Business day." Any day of the week excluding Saturday, Sunday and any legal holiday.

"Complex or chronic medical condition." A physical behavioral or developmental condition that has no known cure, is progressive or can be debilitating or fatal if unmanaged or untreated.

"Covered entity." A contract holder or policy holder providing pharmacy benefits to a covered individual under a health benefit plan pursuant to a contract administered by a pharmacy benefit manager.

"Covered individual." A member, participant, enrollee, or beneficiary of a covered entity who is provided health coverage by the covered entity.

The term includes a dependent or other person provided health coverage through the policy or contract of a covered individual.

"Department." The insurance department of the commonwealth.

"ERISA." The Employee Retirement Income Security Act of 1974 (Public Law 93-406, 29 U.S.C. § 1001 et seq.).

"Extrapolation." The practice of inferring a frequency of dollar amount of overpayments, underpayments, nonvalid claims or other errors on any portion of claims submitted, based on the frequency of dollar amount of overpayments, underpayments, nonvalid claims or other errors actually measured in a sample of claims.

"Health benefit plan." A policy, contract or certificate entered into, offered, issued or renewed by a health insurer to provide, deliver, arrange for, pay for or reimburse any of the costs of physical, mental or behavioral health care services. The term does not include Medicare supplement or accident only, fixed indemnity, limited benefit, credit, dental, vision, specified disease, Tricare supplemental insurance, long-term care or disability income, workers' compensation or automobile medical payment insurance.

"Health care practitioner." As defined in section 103 of the Act of July 19, 1979 ( P.L. 130, No.48), known as the Health Care Facilities Act.

"Health insurer." An entity licensed by the department with authority to issue a policy, subscriber contract, certificate or plan that provides prescription drug coverage that is offered or governed under any of the following:

(1) The Act of May 17, 1921 ( P.L. 682, No.284), known as the Insurance Company Law of 1921, including section 630 and Article XXIV thereof.
(2) The Act of December 29, 1972 ( P.L. 1701, No.364), known as the Health Maintenance Organization Act.
(3)40 Pa.C.S. Ch. 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations).

"Health insurer client." The term includes both a health insurer and a health benefit plan offered by a health insurer.

"Licensee or registrant." An entity subject to oversight of the department under this act. The term includes:

(1) An auditing entity.
(2) A health insurer.
(3) A pharmacy benefit manager.
(4) A pharmacy services administration organization.

"Mail order pharmacy." A pharmacy where prescriptions are dispensed to covered individuals via the mail.

"Maintenance medication." A medication prescribed for a chronic, long-term condition and taken on a regular, recurring basis.

"Maximum allowable cost." The maximum amount that a pharmacy benefits manager will reimburse a pharmacy for the cost of a drug or a medical product or device.

"Multiple source drug." A covered outpatient drug for which there is at least one other drug product that is rated as therapeutically equivalent under the food and drug administration's most recent publication of "approved drug products with therapeutic equivalence evaluations."

"Multiple source generic list." A list of drugs, medical products or devices, or both, for which a maximum allowable cost has been established by a pharmacy benefits manager.

"Network." A pharmacy or group of pharmacies that agree to provide prescription services to covered individuals on behalf of a covered entity or group of covered entities in exchange for payment for its services by a pharmacy benefits manager or pharmacy services administration organization. the term includes a pharmacy that generally dispenses outpatient prescriptions to covered individuals or dispenses particular types of prescriptions, provides pharmacy services to particular types of covered individuals or dispenses prescriptions in particular health care settings, including networks of specialty, institutional or long-term care facilities.

"Nonproprietary drug." As defined in section 2(7.1) of the Act of September 27, 1961 ( P.L. 1700, No.699), known as the Pharmacy Act.

"Pharmacist." As defined in section 2(10) of the Pharmacy Act.

"Pharmacy." As defined in section 2(12) of the Pharmacy Act.

"Pharmacy audit." An audit, conducted on-site by or on behalf of an auditing entity of any records of a pharmacy for prescription or nonproprietary drugs dispensed by a pharmacy to a covered individual.

"Pharmacy benefits management." The performance of any of the following:

(1) The procurement of prescription drugs at a negotiated contracted rate for dispensation within this commonwealth to covered individuals.
(2) The administration or management of prescription drug benefits provided by a covered entity for the benefit of covered individuals.
(3) The administration of pharmacy benefits, including:
(i) Operating a mail-service pharmacy.
(ii) Claims processing.
(iii) Managing a retail pharmacy network .
(iv) Paying claims to a pharmacy for prescription drugs dispensed to covered individuals via retail or mail-order pharmacy.
(v) Developing and managing a clinical formulary , including utilization management and quality assurance programs.
(vi) Rebate contracting and administration.
(vii) Managing a patient compliance, therapeutic intervention and generic substitution program.
(viii) Operating a disease management program.
(ix) Setting pharmacy reimbursement pricing and methodologies, including maximum allowable cost, and determining single or multiple source drugs.

"Pharmacy benefits manager" or "PBM." A person, business or other entity that performs pharmacy benefits management for covered entities.

"Pharmacy record." Any record stored electronically or as a hard copy by a pharmacy that relates to the provision of prescription or nonproprietary drugs or pharmacy services or other component of pharmacist care that is included in the practice of pharmacy.

"Pharmacy services administration organization" or "PSAO." Any entity that contracts with a pharmacy to assist with third-party payer interactions and that may provide a variety of other administrative services, including contracting with pbms on behalf of pharmacies and managing pharmacies' claims payments from third-party payers.

"Rare medical condition." A disease or condition that affects fewer than 200,000 individuals in the United States or approximately 1 in 1,500 individuals worldwide.

"Retail pharmacy." A pharmacy where prescriptions are able to be dispensed to covered individuals on the premises of the pharmacy.

"Specialty drug." Either of the following:

(1) A prescription drug prescribed to a covered individual with a cost that meets or exceeds the cost of a drug on the specialty tier of Medicare Part D under 42 CFR 423.104(D)(2)(IV) (relating to requirements related to qualified prescription drug coverage) and meets three or more of the following criteria:
(i) The drug requires specialized product handling or administration by the dispensing pharmacy.
(ii) The drug requires specialized clinical care, including, but not limited to, frequent dosing adjustments to the prescription drug, clinical monitoring or expanded patient service, intensive patient counseling and ongoing clinical support, such as individualized disease or therapy management to support patient outcomes for a covered individual.
(iii) The drug is prescribed for a covered individual with a rare medical condition, complex or chronic medical condition or life-threatening medical condition.
(iv) The prescription drug has a limited or exclusive distribution and is not typically stocked or dispensed by a retail pharmacy.
(2) A prescription drug that is prescribed to a covered individual and that is listed as a specialty drug on the medical assistance fee-for-service specialty pharmacy drug list.

"Specialty pharmacy." A pharmacy that has been nationally accredited by an independent third party to dispense specialty drugs.

"Spread pricing." A model of prescription drug pricing in which the PBM charges a health benefit plan or health insurer a contracted price for prescription drugs and the contracted price for the prescription drugs differs from the amount the PBM directly or indirectly pays the pharmacist or pharmacy for prescription drugs and related pharmacist services.

40 P.S. § 4503

Amended by P.L. (number not assigned at time of publication) 2024 No. 77,§ 2, eff. 11/14/2024.
Added by P.L. TBD 2016 No. 169, § 103, eff. 5/20/2017.