18 Del. Admin. Code § 1411-2.0

Current through Register Vol. 28, No. 5, November 1, 2024
Section 1411-2.0 - Definitions

The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly indicates otherwise:

"Affiliate" means an entity or person who directly or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with, a specified entity or person.

"Commissioner" means the Insurance Commissioner of Delaware.

"Control" (including the terms "controlling", "controlled by" and "under common control with") means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract other than a commercial contract for goods or non-management services, or otherwise, unless the power is the result of an official position with or corporate office held by the person. Control shall be presumed to exist if any person, directly or indirectly, owns, controls, holds with the power to vote, or holds proxies representing, 10% or more of the voting securities of any other person. This presumption may be rebutted by a showing made in the manner provided by 18 Del.C. Ch. 50 that control does not exist in fact. The Commissioner may determine, after furnishing all persons in interest notice and opportunity to be heard and making specific findings of fact to support the determination that control exists in fact, notwithstanding the absence of a presumption to that effect.

"Department" means the Delaware Department of Insurance.

"Health benefit plan" means any hospital or medical policy or certificate, major medical expense insurance, health service corporation subscriber contract, or health maintenance organization subscriber contract. Health benefit plan does not include accident-only, credit, dental, vision, Medicaid plans, long-term care or disability income insurance, coverage issued as a supplement to liability insurance, worker's compensation or similar insurance, or automobile medical payment insurance.

"Insurer" means any entity that provides health insurance coverage in this State as defined in 18 Del.C. § 903.

"Maximum allowable cost pricing" or "MACP" means drug pricing that meets the requirements of 18 Del.C. § 3323A.

"Network provider" means a pharmacist or pharmacy who provides covered health-care services or supplies to an insured or a member pursuant to a contract with an insurer or pharmacy benefits manager.

"Person" means an individual or a business entity.

"Pharmacy benefits management services" means all of the following:

* The procurement of prescription drugs at a negotiated rate for dispensation within this State to beneficiaries;

* The administration or management of prescription drug coverage provided by a purchaser for beneficiaries; and

* Any of the following services provided with regard to the administration of prescription drug coverage:

1. Mail service pharmacy;
2. Claims processing, retail network management, and payment of claims to pharmacies for prescription drugs dispensed to beneficiaries;
3. Clinical formulary development and management services;
4. Rebate contracting and administration;
5. Patient compliance, therapeutic intervention, and generic substitution programs; and
6. Disease management programs.

"Pharmacy benefits manager" or "PBM" means an entity that contracts with pharmacists or pharmacies on behalf of a person to do any of the following:

* Process claims for prescription drugs or medical supplies or provide retail network management for pharmacies or pharmacists;

* Pay pharmacies or pharmacists for prescription drugs or medical supplies; or

* Negotiate rebates with manufacturers for drugs paid for or procured as described in this chapter.

"Pharmacy benefits manager network" means a network of pharmacists or pharmacies that are offered by an agreement or contract to provide pharmacy goods and services.

"Pharmacy services administrative organization" or "PSAO" means a cooperative network of independent pharmacies.

"Purchaser" means an insurance company, health service corporation, health maintenance organization, managed care organization, and any other entity that does all of the following:

1. Provides prescription drug coverage or benefits in this State; and
2. Enters into agreement with a pharmacy benefits manager for the provision of pharmacy benefits management services.

"Rebate" means a discount or other price concession, or a payment, that is based on utilization of a prescription drug and that is paid by a manufacturer or third party, directly or indirectly, to a pharmacy benefits manager, pharmacy services administrative organization, or pharmacy after a claim has been processed and paid at a pharmacy. "Rebate" includes incentives, disbursements, and reasonable estimates of a volume-based or category-based discount.

"Rural service area" means a five-digit ZIP code in which the population density is less than 1,000 individuals per square mile.

"Suburban service area" means a five-digit ZIP code in which the population density is between 1,000 and 2,500 individuals per square mile.

"Third party" means a person, business, or entity other than a pharmacy benefits manager that is not an enrollee or insured in a health benefit plan.

"Urban service area" means a five-digit ZIP code in which the population density is greater than 2,500 individuals per square mile.

18 Del. Admin. Code § 1411-2.0

26 DE Reg. 594 (1/1/2023) (Final)