Section 0780-01-95-.06 - EXTERNAL APPEAL PROCESS(1) A pharmacy that alleges it did not receive at least its actual cost for a prescription drug or device after resolution of an initial appeal filed with a PBM shall have the right to appeal the decision of the PBM to the Commissioner. The Commissioner may delegate the review and resolution of a pharmacy's appeal under this paragraph, and any decision by the third-party reviewer shall have the same force and effect as a decision by the Commissioner. Any reference to the Commissioner in this rule shall also include a third-party reviewer properly designated by the Commissioner to review and resolve appeals.(2) An appeal filed pursuant to paragraph (1) of this rule must: (a) Be filed with the Commissioner, in such manner as the Commissioner may require, within 30 days of the pharmacy's receipt of the PBM's final determination resolving the pharmacy's initial appeal, unless a different timeframe is approved in writing pursuant to paragraph (3) of this rule;(b) Contain a summary of:1. The grounds of the appeal to the Commissioner;2. The relief requested by the pharmacy; and3. The basis on which the pharmacy believes it is due the relief;(c) Include a copy of the written decision rendered by the PBM;(d) Contain a copy of the invoice(s) showing the pharmacy's purchase price for the drug or medical product or device at issue;(e) Contain a list of all discounts, price concessions, rebates, or other reductions, excluding cash discounts, that were, or should have been, reported to the PBM pursuant to Rule 0780-01-95-.04(1), including supporting documentation for each discount, price concession, rebate, or other reduction;(f) Be submitted on a form or through an electronic process made available by the Department;(g) Contain a certification that all information submitted pursuant to paragraph (1) of this rule is true and accurate to the best of the pharmacy's knowledge; and(h) Provide any other documentation or information requested by the Commissioner regarding the pharmacy's appeal.(3) The Commissioner will not consider any information or documentation received from the pharmacy more than 30 days after the pharmacy's receipt of the PBM's final determination resolving the pharmacy's initial appeal filed with the PBM unless the information reasonably should have been submitted and the withholding of information prevented the Commissioner from reviewing relevant or necessary information as part of the appeal. Prior to the expiration of the 30-day timeframe, the pharmacy may request in writing additional time to investigate and compile the information needed to submit an appeal pursuant to paragraph (1) of this rule. Upon receipt of the pharmacy's written request, or upon the Commissioner's own determination, the Commissioner may, in the Commissioner's discretion, grant the pharmacy an additional period of time determined to be necessary by the Commissioner for good cause shown.(4) Appeals that do not contain all information required under paragraph (2) of this rule shall be considered incomplete and will not qualify for review by the Commissioner under paragraph (7) of this rule until all information has been received. If an appeal is still incomplete more than 30 days after the pharmacy's receipt of the PBM's final determination resolving the pharmacy's initial appeal, or such other timeframe approved in writing pursuant to paragraph (3) of this rule, the pharmacy's appeal shall be automatically denied.(5) The pharmacy whose appeal was denied pursuant to paragraph (4) of this rule may petition the Commissioner in writing for reconsideration and the Commissioner may, in the Commissioner's discretion, grant the petition for reconsideration upon showing good cause for failing to meet the required deadline.(a) When granting a petition for reconsideration, the Commissioner shall establish a new deadline by which all information must be received, and the pharmacy's failure to meet that deadline for any reason will result in an automatic denial of the appeal, which shall be final.(b) For purposes of this paragraph (5), good cause shall not include reasons or processes that were totally or mostly within the control of the appealing pharmacy, including but not limited to administrative oversight, clerical errors, or lack of sufficient personnel.(6) Within ten business days of receipt of notice from the Commissioner the PBM's decision has been appealed, the PBM may file a response to the pharmacy's appeal by providing information supporting its decision made during its internal appeal process.(7) No more than 90 days after the later of the receipt of a complete appeal containing all information required and requested under paragraph (2) of this rule or the receipt of the PBM's response allowed under paragraph (6) of this rule, the Commissioner may: (a) Grant the appeal, in whole or in part, and order the PBM to make such portion of the requested payment to the pharmacy as the Commissioner determines is appropriate to result in the pharmacy receiving at least its actual cost for the prescription drug or medical product or device at issue;(b) Deny the appeal, in whole or in part; or(c) Extend the timeline for rendering a decision by providing the parties with written notice that includes a good-faith estimate of the additional time needed to make a decision.(8) Upon granting or denying an appeal pursuant to paragraph (7) of this rule, the Commissioner shall send the parties a copy of the decision that contains a written justification. The decision of the Commissioner rendered pursuant to paragraph (7) of this rule is final and is not eligible for additional administrative review.(9) If a PBM is required to pay a pharmacy any additional money upon resolution of an appeal pursuant to this rule, the PBM shall make such payment within seven business days of receipt of the Commissioner's written notice issued pursuant to paragraph (8) of this rule. The PBM shall also provide the Department with proof the PBM has reimbursed the pharmacy at least its actual cost for the prescription drug or medical product or device at issue, including a statement of the additional amount paid to the pharmacy, within seven business days of issuing the payment to the pharmacy.(10) If a PBM is required to adjust a challenged rate of reimbursement after an appeal pursuant to this rule is resolved against the PBM, the PBM shall apply the findings from the appeal as to the rate of reimbursement for the drug or medical product or device at issue to other similarly situated pharmacies in the same manner as set forth in Rule 0780-01-95-.04(4).(11) All costs associated with conducting an appeal under this rule, including the expenses of the Department, shall be paid by the applicable PBM. The Commissioner shall bill the PBM upon the conclusion of the appeal. The PBM shall pay the bill in full within 30 days of receipt. Failure to pay a bill in full within 30 days of receipt shall, pursuant to T.C.A. § 56-7-3110, be grounds for the Commissioner to: (a) Suspend, revoke, or refuse to renew a PBM's license issued by the Department; and(b) Order the PBM to pay additional monetary penalties.(12) If a PBM fails to timely pay a bill due pursuant to paragraph (11) of this rule and the Department incurs any costs associated with conducting an appeal under this rule, including but not limited to reimbursement to a third-party contractor, the PBM shall reimburse the Department for those costs, which shall include any fees or interest paid by the Department due to the PBM's failure to pay. The Commissioner shall bill the PBM upon incurring those costs and the PBM shall pay the bill in full within 30 days of receipt. Failure to pay a bill in full within 30 days of receipt shall be grounds for the Commissioner to take any action outlined in paragraph (11) of this rule.(13) When possible, a pharmacy may aggregate and submit appeals for simultaneous review by the Commissioner, or the Commissioner may, in the Commissioner's discretion, aggregate appeals, when the specific reason for denial of the appeals aggregated involves a dispute regarding a common substantive question of fact or law. The mere fact that a claim is not paid, or that appeals relate to the same PBM, does not create a common substantive question of fact or law.(14) This rule applies only to appeals of a PBM's decision rendered pursuant to its initial appeal process established in accordance with T.C.A. § 56-7-3206(c)(2)(A) and approved pursuant to Rule 0780-01-95-.03.Tenn. Comp. R. & Regs. 0780-01-95-.06
Emergency rules filed December 29, 2022; effective through June 27, 2023. New rules filed March 29, 2023; effective 6/27/2023.Authority: T.C.A. §§ 56-2-305, 56-7-3101, 56-7-3110, and 56-7-3206.