18 Del. Admin. Code § 1411-4.0

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

Section 1411-4.0 - Pharmacy Benefits Manager Registration Requirements

4.1 A pharmacy benefits manager shall register with the Commissioner in accordance with this Section before providing pharmacy benefits management services in this State to a purchaser.

4.2 An applicant who wishes to apply to be a pharmacy benefits manager in Delaware shall submit a Pharmacy Benefits Manager Registration Application to the Department, on which the applicant includes all of the following:

4.2.1 Applicant Information:

4.2.1.1 Name, address, telephone number;

4.2.1.2 Name and address of applicant's agent for service of process in this State;

4.2.1.3 Name and address of each person beneficially interested in the applicant's business (e.g. ownership of 10% or more);

4.2.1.4 Name and address of each officer and director;

4.2.1.5 The non-renewable registration fee set forth in Section 8.0 of this regulation;

4.2.2 Organization and Background Information:

4.2.2.1 All basic organizational documents of the applicant, including any articles of incorporation, articles of association, partnership agreement, trade name certificate, trust agreement, shareholder agreement and other applicable documents and all amendments to such documents;

4.2.2.2 The bylaws, rules, regulations or similar documents regulating the internal affairs of the applicant;

4.2.2.3 A biographical affidavit of each individual who is responsible for the conduct of affairs of the applicant, including:

4.2.2.3.1 All members of the board of directors, board of trustees, executive committee or other governing board or committee;

4.2.2.3.2 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;

4.2.2.3.3 Any shareholders or members holding directly or indirectly 10% or more of the voting stock, voting securities or voting interest of the applicant;

4.2.2.3.4 Any other person who exercises control or influence over the affairs of the applicant; and

4.2.2.4 For each individual who is required to submit a biographical affidavit pursuant to subsection 4.2.2.3 of this regulation, a background check that has been performed by an independent third-party within six months of the date of the signature on the relevant biographical affidavit, chosen by the affiant from the list of approved vendors located on the NAIC website under the Uniform Certificate of Authority Application which may be downloaded from naic.org.

4.2.3 A statement describing the applicant's business plan, that includes the following information:

4.2.3.1 Staffing levels and activities proposed in Delaware and nationwide;

4.2.3.2 Details concerning the applicant's capability for providing a sufficient number of experienced and qualified personnel in the areas of claims processing and record keeping;

4.2.3.3 A list of all insurers for whom applicant provides pharmacy benefits management services in this State; and

4.2.4 Information on the applicant's compliance with Chapter 33A requirements, including:

4.2.4.1 A copy of the PBM's standard, generic contract template, provider manual or other appropriate items incorporated by reference that the PBM uses for contracts entered into by the PBM with pharmacists, pharmacies or pharmacy services administrative organizations in this State in administration of pharmacy benefits for insurers, for the purpose only of the Department's review that such contracts comply with 18 Del.C. Ch. 33A;

4.2.4.2 A copy of the written policies and procedures which demonstrate that the applicant has compliant processes established to adhere to all of the following:

4.2.4.2.1 The appeals and dispute resolution process as required by 18 Del.C. § 3324A;

4.2.4.2.2 The requirements for maximum allowable cost pricing set forth in 18 Del.C. § 3323A;

4.2.4.2.3 The Audit Integrity Program set forth in 18 Del.C. §§ 3301A- 3310 A.

4.2.5 Such other pertinent information as may be required by the Commissioner to verify the information in the application.

4.3 A registration certificate issued under this section shall remain valid, unless surrendered, suspended or revoked by the Commissioner, until May 1 following the effective date of the initial registration and the May 1 following the date of the registration renewal, as provided in subsection 4.4 of this regulation.

4.4 No pharmacy benefits manager may continue to do business in Delaware unless it has registered annually with the Commissioner on or before May 1 following the effective date of the initial registration and on or before the May 1 following the date of any subsequent registration renewal. A pharmacy benefits manager may renew a certificate of registration for an additional one-year term by timely submitting:

4.4.1 All of the information required in subsection 4.2 of this regulation, updated as necessary to reflect the most current information concerning the pharmacy benefits manager's operations; and

4.4.2 The non-refundable renewal application fee set forth in Section 8.0 of this regulation.

4.5 A pharmacy benefits manager who is registered or who is applying for registration under Section 4.0 of this regulation shall, within 15 days after the end of the calendar month in which any of the foregoing transactions occur, notify the Commissioner of any material change in its ownership, control, or other fact or circumstance affecting its qualification for a registration certificate in this state.

4.6 A pharmacy benefits manager who is applying for registration or who is registered under this Section shall make available for inspection by the Commissioner copies of each permit issued to each nonresident pharmacy under 24 Del.C. § 2535 that the pharmacy benefits manager uses to ship, mail, or deliver prescription drugs or devices in this state.

18 Del. Admin. Code § 1411-4.0

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