This chapter applies to all cost pricing and reimbursement disputes or a request to review the failure to pay the contractual reimbursement amount of a submitted claim made to a pharmacy benefits manager by a pharmacist or pharmacy for a prescription drug, medical product, or device, provided to a beneficiary of a purchaser. In this chapter, the following terms have the meanings indicated. Terms Defined. “Appeal decision” means a written or electronic notice in response to an appeal under this chapter provided to a contracted pharmacy that includes a reason for the appeal denial. “Beneficiary” means an individual who receives prescription drug coverage or benefits from a purchaser. “Carrier” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Compensation program” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Complaint” means a communication by a contracted pharmacy that disputes the appeal decision, and is submitted on a complaint form to the Commissioner, after the pharmacy benefits manager’s internal appeal process has been exhausted as required by Insurance Article, §15-1628.2, Annotated Code of Maryland. “Complaint form” means the form developed by the Commissioner under Regulation .05 of this chapter. “Contracted pharmacy” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Direct or indirect remuneration fee” means an adjustment in total compensation received directly or indirectly by a contracted pharmacy from a PBM that is determined after the sale of the product or service, including an adjustment of an adjudicated claim based on the use of a generic effective rate or fee or performance-based reimbursement. “Participating pharmacy contract” means a contract filed with the Commissioner that is: Between a pharmacy and a: Pharmacy benefits manager; Pharmacy services administrative organization; or Group purchasing organization; Filed as required by the Commissioner; Not disapproved by the Commissioner; and In compliance with the requirements stated in this chapter. “Pharmacist” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland. “Pharmacy” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland. “Pharmacy benefits management services” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy benefits manager” or “PBM” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy services administration organization” or “PSAO” means an entity that provides a contracted pharmacy with contracting administrative services relating to prescription drug benefits. “Pricing information” means anything used in the mathematical calculation to determine the payment to a contracted pharmacy. “Purchaser” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. Review Decision. “Review decision” means a written or electronic notice in response to a request from a contracted pharmacy for a review of a failure to pay the contractual reimbursement amount of a submitted claim. “Review decision” does not include an appeal decision. “Source” means the publisher or publishers stated in the participating pharmacy contract, used by the PBM, in any manner, to establish the basis of the PBM’s pricing or the reimbursement amount to a contracted pharmacy, under a participating pharmacy contract’s stated compensation program. “Working day” means any day that the Maryland Insurance Administration is open for business. A PBM, whether its contract is directly with a pharmacy or indirectly with a pharmacy through a PSAO or group purchasing organization, shall disclose to a contracted pharmacy at the time of entering into a contract with a pharmacy and at least 30 working days before any contract change for a contracted pharmacy: The applicable terms, conditions, and reimbursement rates, including: The sources; and The terms of the compensation program; The process and procedures for verifying pharmacy benefits and beneficiary eligibility; The dispute resolution, internal appeal process under Regulation .04 of this chapter, and audit appeals process; and The process and procedures for verifying the prescription drugs included on the formularies used by the PBM. A claim paid on behalf of a carrier to a contracted pharmacy under a participating pharmacy contract is subject to the requirements of Insurance Article, §§15-1005, 15-1008, 15-1009, and 15-1631, Annotated Code of Maryland. Each PBM subject to this chapter shall establish written procedures to investigate and resolve disputes filed by a contracted pharmacy. The internal appeal procedures established by the PBM shall: Be in writing; and Contain administrative processes and safeguards designed to ensure and verify that the pricing was determined in accordance with the participating pharmacy contract and Maryland law, and that the contract provisions have not been applied in an arbitrary or capricious manner. The procedures established by the PBM may not require: More than one appeal before filing a complaint with the Commissioner; or The payment of a fee to file an appeal. The internal appeal procedures established by the PBM shall be provided to the Commissioner on request. The internal procedures established by the PBM shall: Provide written notice of the PBM’s decision no later than 90 days after receipt of the appeal or review; Pay any money due within 30 days after the internal review is complete; and Provide a contracted pharmacy: 21 days to file an appeal after the contracted pharmacy is charged a direct or indirect remuneration fee; or A minimum of 180 days to request review of the reimbursement amount of a submitted claim. Prior to filing a complaint with the Commissioner, a contracted pharmacy or its designee shall exhaust the internal appeal process established in the participating pharmacy contract. A contracted pharmacy or its designee may file a complaint with the Commissioner to dispute a PBM’s appeal decision for the following reasons: The PBM’s cost pricing did not comply with Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland; or The PBM’s cost pricing or reimbursement amount determination did not meet the terms of the applicable participating pharmacy contract. A complaint is properly completed and may be filed if a contracted pharmacy or its designee: Completes all applicable portions of the Commissioner’s complaint form; Provides a copy of the relevant contract or the provisions that are related to the appeal, including but not limited to establishing a drug pricing or pharmacy reimbursement amount, sources, pricing information, and the compensation program of the applicable participating pharmacy contract; and Provides a copy of the appeal decision. A complaint may not include more than ten appeal decisions using a single complaint form. Notification of the Complaint to the PBM. Upon receipt of a completed complaint form, the Commissioner shall provide a copy of the submitted complaint form to the PBM. Within 5 working days of receiving the Commissioner’s notice, the PBM shall provide the Commissioner: A complete, unredacted copy of the applicable portion of the participating pharmacy contract relating to the compensation program and the complaint filed with the Commissioner, including any other contract under which the pricing or reimbursement amount is determined; A copy of the applicable source and pricing information used to calculate the pharmacy reimbursement amount; A mathematical calculation that demonstrates how the reimbursement amount was determined; All information required to complete the response portion of the complaint form; and Any other information the Commissioner may require for the purposes of determining a PBM’s compliance with: Insurance Article, Annotated Code of Maryland; This chapter; The compensation program; or The applicable terms of the participating pharmacy contract. Insurance Article, §§15-1601, 15-1604, 15-1605, 15-1607, 15-1609, 15-1628, 15-1628.2, 15-1630, and 15-1642, Annotated Code of Maryland Effective date: Effective March 23, 2020 (47:6 Md. R. 343) Regulation .02B amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .03 amended effective February 7, 2022 (49:3 Md. R. 141)