CHAPTER 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, § 2]
Subchapter V. Registration of Pharmacy Benefits Managers
For purposes of this subchapter:
(1) “Pharmacy benefits management services” means all of the following:
a. The procurement of prescription drugs at a negotiated rate for dispensation within this State to beneficiaries.
b. The administration or management of prescription drug coverage provided by a purchaser for beneficiaries.
c. 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. For purposes of this paragraph (1)c.4., “rebate” means as defined in § 3361A of this title.
5. Patient compliance, therapeutic intervention, and generic substitution programs.
6. Disease management programs.
(2) “Pharmacy benefits manager” means as defined under § 3302A of this title.
(3) “Purchaser” means a person that does all of the following:
a. Provides prescription drug coverage or benefits in this State.
b. Enters into agreement with a pharmacy benefits manager for the provision of pharmacy benefits management services.82 Del. Laws, c. 115, § 4; 83 Del. Laws, c. 256, § 8;
This subchapter does not apply to plans of health insurance or health benefits designed for issuance to persons eligible for coverage under Titles XVIII, XIX, and XXI of the Social Security Act, 42 U.S.C. §§ 1395 et seq., 1396 et seq., and 1397aa et seq., known as Medicare, Medicaid, or any other similar coverage under a state or federal government plan.82 Del. Laws, c. 115, § 4;
(a) A pharmacy benefits manager shall register with the Commissioner as a pharmacy benefits manager before providing pharmacy benefits management services in this State to a purchaser.
(b) A purchaser may not enter into an agreement or contract with a pharmacy benefits manager that has not registered with the Commissioner.
(c) A pharmacy benefits manager applying for registration shall do all of the following:
(1) File with the Commissioner an application on the form that the Commissioner provides.
(2) Pay to the Commissioner a $1,000 nonrefundable registration fee.
(d) The Commissioner may require any additional information or submissions from a pharmacy benefits manager that may be reasonably necessary to verify the information contained in the application.
(e) Subject to § 3355A of this title, the Commissioner shall register each pharmacy benefits manager that meets the requirements of this section.
(f) Except where prohibited by state or federal law, a pharmacy benefits manager applying for registration is deemed to have appointed the Commissioner as agent for service of process in an action or proceeding arising in this State out of or in connection with the exercise of the registration. The appointment of the Commissioner as agent for service of process is irrevocable during the period within which a cause of action against the pharmacy benefits manager may arise out of transactions with respect to pharmacy benefits management services provided in this State. The process must be served on the Commissioner or a Deputy Insurance Commissioner or another person designated by the Commissioner by rule or regulation.82 Del. Laws, c. 115, § 4; 83 Del. Laws, c. 256, § 9;
(a) A pharmacy benefits manager registration expires on May 1 after its effective date unless it is renewed as provided under this section.
(b) A pharmacy benefits manager may renew its registration for an additional 1-year term if the pharmacy benefits manager otherwise is entitled to be registered and does all of the following:
(1) Files with the Commissioner a registration renewal application on the form that the Commissioner requires.
(2) Pays to the Commissioner a $1,000 nonrefundable renewal fee.
(c) An application for renewal of a pharmacy benefits manager registration is to be considered made in a timely manner if it is postmarked on or before the date the pharmacy benefits manager’s registration expires.
(d) The Commissioner may require additional information or submissions from a pharmacy benefits manager that may be reasonably necessary to verify the information contained in the registration renewal application.
(e) Subject to §§ 3355A of this title, the Commissioner shall renew the registration of each pharmacy benefits manager that meets the requirements of this section.82 Del. Laws, c. 115, § 4; 83 Del. Laws, c. 256, § 10;
(a) The Commissioner may deny a registration to a pharmacy benefits manager applicant or refuse to renew, suspend, or revoke the registration of, or issue a cease and desist order to, a pharmacy benefits manager if the pharmacy benefits manager, or an officer, director, or employee of the pharmacy benefits manager, does any of the following:
(1) Makes a material misstatement, misrepresentation, or omission in a registration or registration renewal application.
(2) Fraudulently or deceptively obtains or attempts to obtain a registration or renewal of a registration.
(3) In connection with the administration of pharmacy benefits management services, commits fraud or engages in illegal or dishonest activities.
(4) Violates any provision of this chapter or a regulation adopted under this chapter.
(c) If the action by the Commissioner is to deny or not renew a registration, the Commissioner shall notify the pharmacy benefits manager of the decision, in writing, including the reason for the denial or nonrenewal of the registration. The pharmacy benefits manager may, within 10 days after the Commissioner provides notice under this subsection, make written demand on the Commissioner for a hearing before the Commissioner to determine the reasonableness of the Commissioner’s action. A hearing under this subsection must be held under §§ 323 through 328 of this title.
(d) This section does not limit any other regulatory authority of the Commissioner under this title.82 Del. Laws, c. 115, § 4; 83 Del. Laws, c. 256, § 11;
A pharmacy benefits manager shall maintain adequate books and records about each purchaser for which the pharmacy benefits manager provides pharmacy benefits management services as follows:
(1) In accordance with prudent standards of record keeping.
(2) For the duration of the agreement between the pharmacy benefits manager and the purchaser.
(3) For 3 years after the pharmacy benefits manager ceases to provide pharmacy benefits management services for the purchaser.82 Del. Laws, c. 115, § 4;
(a) Whenever the Commissioner considers it advisable, the Commissioner may examine the affairs, transactions, accounts, and records of a registered pharmacy benefits manager.
(b) The examination must be conducted under § 320 of this title.
(c) The expense of an examination is to be borne by the pharmacy benefits manager being examined. The expense includes the reasonable and proper expenses of the Commissioner, and the Commissioner’s examiners and assistants, including expert assistance, and a reasonable per diem as to the examiners and assistants as necessarily incurred in the examination. The pharmacy benefits manager examined shall promptly pay the examination expense on presentation by the Commissioner or the Commissioner’s examiner of a reasonably detailed written account of the examination expense.
(d) The Commissioner shall issue reports of the examination and investigation under § 321 of this title.82 Del. Laws, c. 115, § 4;
A pharmacy benefits manager may not ship, mail, or deliver prescription drugs or devices to a person in this State through a nonresident pharmacy unless the nonresident pharmacy holds a permit issued under § 2535 of Title 24.82 Del. Laws, c. 115, § 4;
82 Del. Laws, c. 115, § 4Transferred to § 3373A of this title by 83 Del. Laws, c. 256, § 14, effective Oct. 26, 2021.