Section 0780-01-95-.05 - TIMING AND NOTICE REQUIREMENTS FOR INITIAL APPEAL PROCESSES(1) A PBM's initial appeal process, or a pharmacy's participation in an initial appeal, must meet the following requirements:(a) The pharmacy must file its initial appeal within seven business days of its submission of the initial claim for reimbursement for the drug or medical product or device;(b) The PBM or covered entity must make a final determination resolving the pharmacy's initial appeal within seven business days of the PBM's or covered entity's receipt of an initial appeal that includes all information required by paragraph (2) of this rule; and(c) Each PBM shall make its initial appeal process available on its secure website. The PBM's secure website must include all deadlines applicable to its initial appeal process, a description of the steps contained within its initial appeal process, and a telephone number, email address, web portal, or any other process that a pharmacy may use to submit initial appeals. The website shall clearly state that the PBM's initial appeal process is available for all prescription drugs or devices in Tennessee for which a pharmacy alleges it did not receive its actual cost.(2) The timeline for making a final determination resolving an initial appeal under T.C.A. § 56-7-3206(c)(2)(B)(ii) shall not begin until the PBM has received all required information sufficient to allow the PBM to conduct a complete analysis of the initial appeal. A PBM shall be deemed to have received all required information sufficient to allow the PBM to conduct a complete analysis of the initial appeal upon receipt of: (a) A complete version of either an initial appeal form provided by the Commissioner to be used by a pharmacy to file an initial appeal or the PBM's appeal form submitted and approved pursuant to Rule 0780-01-95-.03(2)(e); and(b) Certification from the pharmacy it has provided the PBM with all invoices or other records demonstrating the pharmacy's actual cost for the drug or medical product or device at issue, which shall take into account all discounts, price concessions, rebates, or other reductions received as of the date the pharmacy filed its initial appeal.(3) If a PBM receives an initial appeal from a pharmacy that does not contain all information required under paragraph (2) of this rule, the PBM shall accept the incomplete initial appeal and hold it open pending receipt of additional information from the pharmacy. Within five business days of receipt of an incomplete initial appeal, the PBM shall notify the pharmacy of the information needed to complete the initial appeal and initiate the PBM's review. The pharmacy may respond within five business days of receipt of the PBM's notice outlining the requested information. If the pharmacy provides the requested information, the timeline for making a final determination outlined in subparagraph (1)(b) of this rule shall start. If the pharmacy fails to provide the requested information within five business days of receipt of the PBM's notice, the PBM may deny the initial appeal pursuant to T.C.A. § 56-7-3206(c)(4).(4) A PBM may not delay the start of its review of an initial appeal by: (a) Requiring additional or different information from a pharmacy beyond what is required to be submitted to the PBM under its initial appeal process approved by the Commissioner pursuant to Rule 0780-01-95-.03(3)(a) 1.; or(b) Basing the delay on administrative or non-substantive errors or omissions in any of the filings that do not affect the overall validity of the initial appeal.(5) If a PBM fails to comply with the timing and notice requirements under T.C.A. § 56-7-3206(c)(2)(B)(ii) and this rule, the pharmacy's initial appeal shall be resolved by the PBM in favor of the pharmacy. If a pharmacy fails to comply with the timing requirements under T.C.A. § 56-7-3206(c)(2)(B)(ii) and this rule, the PBM may deny the initial appeal pursuant to T.C.A. § 56-7-3206(c)(4).(6) Each PBM must submit the initial appeal process it will use for approval by the Commissioner regardless of whether it outsources the administration of its initial appeal process to a third-party administrator or a different PBM. Each PBM will retain ultimate responsibility for ensuring it complies with this paragraph regardless of whether the PBM conducts its own initial appeal process or utilizes another PBM or a third-party administrator.Tenn. Comp. R. & Regs. 0780-01-95-.05
Emergency rules filed December 29, 2022; effective through June 27, 2023. New rules filed March 29, 2023; effective June 27, 2023. Amendments filed March 28, 2024; effective 6/26/2024.Authority: T.C.A. §§ 56-7-3101 and 56-7-3206.