18 Del. Admin. Code § 1411-12.0

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

Section 1411-12.0 - Review and Approval of Claim Adjudication Fees and Pharmacy Standards

12.1 Unless approved in advance by the Commissioner as provided in this Section 12.0, no PBM may do either of the following:

12.1.1 Charge a pharmacist or pharmacy a fee related to the adjudication of a claim, including a fee for any of the following:

12.1.1.1 The receipt and processing of a pharmacy claim;

12.1.1.2 The development or management of claims processing services in a pharmacy benefits manager network; or

12.1.1.3 Participation in a pharmacy benefits manager network; or

12.1.2 Require a pharmacy accreditation standard or certification requirement that is inconsistent with, more stringent than, or in addition to any requirements of the Board of Pharmacy.

12.2 To seek Commissioner approval of a fee as required under subsection 12.1.1 of this regulation, a PBM shall provide the following minimum information:

12.2.1 The name, registration number and contact information of the PBM;

12.2.2 The fee for which the PBM seeks approval;

12.2.3 A statement regarding how the fee is to be charged, the need for the fee, and whether the fee represents a new fee, or an increase or decrease in a previously-charged fee;

12.2.4 A statement as to whether the requested fee applies to all contracted pharmacies within its complete network or a subset of contracted pharmacies. If the fee applies only to a subset of contracted pharmacies and/or the amount of the fee varies among contracted pharmacies, the statement should include the reason for the differential treatment among contracted pharmacies;

12.2.5 The PBM's anticipated revenue from the fee; and

12.2.6 Any other information the PBM wants the Department to consider as justification for the proposed fee.

12.3 To seek Commissioner approval of a pharmacy accreditation standard or certification requirement as required under subsection 12.1.2 of this regulation, a PBM shall provide the following minimum information on a form provided by the Department for such purposes:

12.3.1 The name, registration number and contact information of the PBM;

12.3.2 The accreditation standard or certification requirement sought to be implemented;

12.3.3 A statement of how the accreditation standard or certification requirement deviates from the requirements of the Board of Pharmacy;

12.3.4 Detailed justification for the necessity of an accreditation standard or certification requirement that is inconsistent with, more stringent than, or in addition to the requirements of the Board of Pharmacy, including the risk it is intended to mitigate and why the Board of Pharmacy standards are not sufficient for those purposes;

12.3.5 A statement whether the accreditation standard or certification requirement applies to all contracted pharmacies or a subset of contracted pharmacies. If the standard or requirement applies only to a subset of contracted pharmacies, the statement should include the reason for the differential treatment among contracted pharmacies;

12.3.6 A statement describing how application of the accreditation standard or certification requirement may impact patient access to pharmacy services or the PBM's network;

12.4 Upon receipt by the Department of a submission pursuant to subsection 12.3 of this regulation, the Department shall forward a copy of the submission to the Executive Director of the Board of Pharmacy to be placed on the agenda for the Board of Pharmacy's next available public meeting.

12.4.1 The PBM shall supplement its filing under subsection 12.3 of this regulation with any additional information requested by either the Department or the Board of Pharmacy.

12.4.2 Following consideration of the submission by the Board of Pharmacy, the Department shall take under advisement any recommendation provided or position taken by the Board of Pharmacy regarding the additional accreditation standard or certification requirement when rendering a final decision on the PBM's sub-mission under subsection 12.3 of this regulation.

18 Del. Admin. Code § 1411-12.0

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