18 Del. Admin. Code § 1411-9.0

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

Section 1411-9.0 - Pharmacy Provider Appeals Related to Maximum Allowable Cost Pricing (MACP) Reimbursements

9.1 A PBM shall designate the name, address, phone number, and electronic mail address of the person within the PBM organization who shall be the point of contact for responding to appeals received by the Department from a pharmacy provider or PSAO under 18 Del.C. § 3324A(h).

9.2 All filings submitted to the Department, including the notice of appeal and any subsequent responses by either party shall be made by electronic mail to the electronic mail address designated by the Department on the Department's website.

9.3 Notice and Manner of Service

9.3.1 Notice and manner of service, except service of the notice of appeal, is sufficient and complete if properly addressed, upon mailing the same with prepaid first-class U.S. Postage.

9.3.2 Service of the initial notice of appeal shall be made by the pharmacy or PSAO on the PBM by Certified U.S. Postage and return receipt requested or hand delivery to the respondent and is complete upon receipt by addressee or an employee in respondent's place of business.

9.3.3 The parties must provide a brief statement verifying the service of all filed papers with the manner, date and address of service.

9.4 When an Appeal May Be Commenced

9.4.1 An appeal may be commenced after the pharmacy provider or PSAO and a PBM have attempted to resolve the matter in accordance with the PBM's internal appeal process required by 18 Del.C. § 3324A(a).

9.4.2 A PBM's failure to communicate and process an internal appeal, as required under 18 Del.C. § 3324A, or its failure to abide by its MACP appeal processes as described to the Department in the PBM's submission under subsection 4.2.4.2.1 of this regulation, shall constitute a denial under the internal appeal process for purposes of allowing the pharmacy provider or PSAO on its behalf to file an appeal with the Department.

9.4.3 The Commissioner may dismiss the appeal without prejudice if the Commissioner finds that the parties have not exhausted the PBM's internal appeals process.

9.4.4 A PBM shall not be held responsible for failure to timely process an internal appeal in the event that a pharmacy provider or PSAO acting on its behalf has not submitted sufficient information for the PBM to process the appeal.

9.4.5 All pricing information and data collected by the Department for purposes of processing an appeal under Section 9.0 of this regulation is confidential and is not subject to subpoena or the Freedom of Information Act, 29 Del.C. Ch. 100.

9.5 Commencement of Appeal

9.5.1 A pharmacy provider or PSAO may commence an appeal by filing a notice of appeal on a form provided by the Department and as specified at subsection 9.2 of this regulation, with the supporting documents or other evidence attached thereto. The pharmacy provider or PSAO shall at the same time serve a copy of the same notice of appeal and supporting documents to the PBM or PBM's representative and a statement verifying service in accordance with subsection 9.3 of this regulation. The Department may return any non-conforming notice of appeal.

9.5.2 Within 5 business days of receipt of the notice of appeal, the responding PBM ("Respondent") shall file a response on a form provided by the Department and as specified at subsection 9.2 of this regulation, that shall include a copy of the contract between the PBM and the appealing pharmacy provider or PSAO, along with any other documentation necessary for the Department to review the PBM's compensation program to determine whether the reimbursement underlying the appeal complies with 18 Del.C. §§ 3323A- 3324 A and the terms of the contract. The PBM shall at the same time serve a copy of the same response to the pharmacy provider or PSAO and a statement verifying service in accordance with subsection 9.3 of this regulation. The Department may return any non-conforming response.

9.5.3 If the Respondent fails to file a response in a timely fashion, the Department, after verifying proper service and notice to the parties, may enter a summary disposition. The Department may determine the matter in the nature of a default judgment after establishing that the appeal is properly supported and was properly served on Respondent. The Department may allow the re-opening of the matter to prevent a manifest injustice. A request for re-opening must be made no later than 5 business days after notice of the default judgment.

9.6 Consideration of Appeal

9.6.1 The Department shall consider the matter based on the submissions of the parties and information otherwise requested from the parties by the Department. The Department shall not consider any matter not contained in the original or supplemental submissions of the parties which has not been provided to the opposing party with at least 5 business days' notice, except claims of a continuing nature which are set out in the filed papers.

9.6.2 The Department shall review the pharmacy benefits manager's compensation program to ensure that the reimbursement for pharmacy benefits management services paid to the pharmacist or a pharmacy complies with 18 Del.C. §§ 3323A- 3324 A and the terms of the contract between the PBM and the appealing pharmacy or PSAO and shall either:

9.6.2.1 Dismiss the appeal; or

9.6.2.2 Grant the appeal and order the pharmacy benefits manager to pay the claim in accordance with the Department's findings.

18 Del. Admin. Code § 1411-9.0

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