18 Del. Admin. Code § 1411-6.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 1411-6.0 - Grounds for Denial, Suspension or Revocation of Registration Certificate

6.1 The Commissioner may deny, refuse to renew, suspend, or revoke the certificate of registration of a pharmacy benefits manager if the Commissioner finds that the pharmacy benefits manager or an officer, director, or employee of the pharmacy benefits manager has engaged in any of the following:

6.1.1 Making a material misstatement, misrepresentation, or omission in a registration or registration renewal application, including but not limited to:

6.1.1.1 Failure to meet any qualification for which issuance of the certificate could have been refused had the failure then existed and been known to the Commissioner;

6.1.1.2 Failure to timely file an annual registration pursuant to Section 4.0 of this regulation and filing fee pursuant to Section 8.0 this regulation;

6.1.1.3 Failure to disclose that its license, registration or certification is under suspension or revocation in another state; or

6.1.1.4 Failure to disclose that individuals who are responsible for the conduct of the affairs of the pharmacy benefits manager have been convicted of, or have entered a plea of guilty or nolo contendere to a felony without regard to whether adjudication was withheld;

6.1.2 Fraudulently or deceptively obtaining or attempting to obtain a registration or renewal of a registration;

6.1.3 In connection with the administration of pharmacy benefits management services, committing fraud or engaging in illegal or dishonest activities, including but not limited to:

6.1.3.1 Using such methods or practices in the conduct of its business that render its further transaction of business in Delaware hazardous or injurious to insured persons or the public;

6.1.3.2 Violating any lawful rule or order of the Commissioner or any applicable law of this state;

6.1.3.3 Failing to pay any judgment rendered against it in this state within sixty days after the judgment has become final; or

6.1.3.4 Without just cause, refusing to make reimbursements in compliance with its contracts and as required by law; or

6.1.4 Violating any provision of 18 Del.C. Ch. 33A or this regulation, including but not limited to:

6.1.4.1 In connection with the affairs of the pharmacy benefits manager, refusing to be examined or to produce pharmacy benefits manager-related accounts, records and files for examination, of any individual responsible for the conduct of affairs of the pharmacy benefits manager, including:

6.1.4.1.1 Members of the board of directors, board of trustees, executive committee or other governing board or committee;

6.1.4.1.2 The principal officers in the case of a corporation or the partners or members in the case of a partnership, association or limited liability company;

6.1.4.1.3 Any shareholder or member holding directly or indirectly 10% or more of the voting stock, voting securities or voting interest of the pharmacy benefits manager; and

6.1.4.1.4 Any other person who exercises control or influence over the affairs of the pharmacy benefits manager; or

6.1.4.2 Reimbursing a pharmacy or pharmacist in this State in an amount less than the amount that the PBM reimburses a PBM affiliate for providing the same pharmacy goods or services;

6.1.4.3 Refusing to give information with respect to its affairs or refusing to perform any other legal obligation as to an examination, when required by the Commissioner; or

6.1.4.4 Engaging in any of the prohibited practices identified in 18 Del.C. § 3372A.

6.2 In addition to any other remedies set forth in this regulation, the Commissioner may issue a cease-and-desist order to a pharmacy benefits manager that is registered or is seeking renewal of a registration if the pharmacy benefits manager, or an officer, director, or employee of the pharmacy benefits manager commits any of the acts set forth in subsection 6.1 of this regulation.

6.3 If a pharmacy benefits manager that is registered or seeking renewal of a registration does not comply with a cease-and-desist order issued by the Commissioner under subsection 6.2 of this regulation, the Commissioner may deny, refuse to renew, suspend, or revoke its registration.

6.4 Hearings

6.4.1 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.

6.4.2 If the Commissioner determines that a pharmacy benefits manager has violated any provision of 18 Del.C. Ch. 33A or this regulation, the Commissioner may, after notice and a hearing, issue an order in accordance with 18 Del.C. § 3373A.

6.4.3 All hearings under this regulation must be held under 18 Del.C. §§ 323 through 328 and this regulation.

18 Del. Admin. Code § 1411-6.0

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