This chapter applies to the submission of a pharmacy services administrative contract or an amendment to a pharmacy services administrative contract required to be filed under Insurance Article, Title 15, Subtitle 20, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Commissioner” means the Maryland Insurance Commissioner. “Contracted pharmacy” means an independent pharmacy in a contract with a pharmacy services administrative organization. “Independent pharmacy” has the meaning stated in Insurance Article, §15-2001(b), Annotated Code of Maryland. “Noncompliant” means a contract or amendment that is not in compliance with Maryland statutes and regulations. “Pharmacy benefits manager (PBM)” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy services administrative contract” has the meaning stated in Insurance Article, §15-2001(d), Annotated Code of Maryland. “Pharmacy services administrative organization” or “PSAO” has the meaning stated in Insurance Article, §15-2001(e), Annotated Code of Maryland. Pursuant to the requirements of Insurance Article, §15-2010, Annotated Code of Maryland, and except as provided in §E of this regulation, a PSAO shall submit to the Commissioner all pharmacy services administrative contract forms and amendments to pharmacy services administrative contract forms. Unless it is disapproved by the Commissioner, and except as provided in §E of this regulation, a PSAO may not use a contract form or amendment to a contract form unless it has been filed with the Commissioner and: 60 days have passed since the filing was acknowledged by the Commissioner in writing as having been received; or Subject to the filing corrections under §C of this regulation, a PSAO receives written notice from the Commissioner that the contract form or amendment to a contract form may be used in Maryland. A PSAO that receives written notice from the Commissioner that its contract form or amendment to a contract form contains defects and is disapproved, may re-submit the disapproved forms indicating the corrections made. Except for the circumstances in §C of this regulation, a PSAO may not file a contract form or amendment form that has been previously disapproved by the Commissioner. Amendments to Contracts. A PSAO that amends any of the following provisions of a previously filed contract shall file the amendment form with the Commissioner: Any provision dealing with prohibitions on certain communications between a pharmacy or pharmacist and a beneficiary, as described in Insurance Article, §15-1611, Annotated Code of Maryland; Any provision dealing with the responsibility of a PBM to disclose specified information to a pharmacy, as described in Insurance Article, §15-1628, Annotated Code of Maryland; Any provision dealing with fees for credentialing a pharmacy or pharmacist to participate in the network of a PBM or purchaser or the frequency of credentialing renewals, as described in Insurance Article, §15-1628, Annotated Code of Maryland; Any provision describing the sources used to determine maximum allowable cost pricing, the process for updating pricing information, or the process to appeal, investigate, and resolve disputes regarding maximum allowable cost pricing, as described in Insurance Article, §15-1628.1, Annotated Code of Maryland; Any provision describing the process to appeal, investigate, and resolve disputes regarding cost pricing and reimbursement, as described in Insurance Article, §15-1628.2, Annotated Code of Maryland; Any provision dealing with a pharmacy being charged or held responsible for a fee or performance-based reimbursement related to the adjudication of a claim or an incentive program or being subject to a reduction in payment due to a reconciliation process, as described in Insurance Article, §15-1628.3, Annotated Code of Maryland; Any provision describing the process to audit pharmacies, as described in Insurance Article, §15-1629, Annotated Code of Maryland; Any provision dealing with retroactive denials or modifications of reimbursement to a pharmacy or pharmacist, as described in Insurance Article, §15-1631, Annotated Code of Maryland; Any provision dealing with therapeutic interchanges, as described in Insurance Article, §§15-1633, 15-1634, 15-1635, 15-1636, and 15-1637, Annotated Code of Maryland; Any provision dealing with the PSAO providing copies of contracts, amendments, payment schedules, or reimbursement rates to a pharmacy, as described in Insurance Article, §15-2011, Annotated Code of Maryland; Any provision dealing with notification to a pharmacy of a material change in ownership or control of certain organizations affiliated with the PSAO, as described in Insurance Article, §15-2013, Annotated Code of Maryland; Any provision dealing with the PSAO passing claims remittances from a PBM or purchaser to a pharmacy, as described in Insurance Article, §15-2015, Annotated Code of Maryland; Any provision describing an arrangement for a pharmacy to purchase drugs, biologics, or medical devices from an entity under common ownership with the PSAO, as described in Insurance Article, §15-2016, Annotated Code of Maryland; Any provision dealing with the applicability of Maryland law; or Any provision of the contract that is revised to comply with Maryland law. An amendment to a previously filed contract form that does not amend a provision described in §E(1) of this regulation is not required to be filed with the Commissioner. A filing made under this chapter shall include a cover letter which includes the following: A list of the contract forms and amendment forms included in the submission; and A brief description of the purpose of each contract form and amendment form included in the submission. Each page of a contract or amendment shall be identified by a form number which is unique to that form. This number shall be printed in the lower left-hand corner of each page, and no other number shall appear in close proximity to the form number. A filing made under this chapter shall include a signed certification from a responsible officer of the PSAO that, to the best of the officer’s knowledge and belief, the contract forms and amendment forms comply with applicable statutes and regulations. A PSAO may not file a contract form or amendment form before the PSAO has successfully registered as a PSAO with the Commissioner. A PSAO may have a contract form or amendment to a contract form disapproved if the contract or amendment contains or uses any language that: Violates Title 15, Subtitle 16 or Subtitle 20 of the Insurance Article, Annotated Code of Maryland or any applicable statutory provisions, including but not limited to Insurance Article, §§15-1611, 15-1628, 15-1628.1, 15-1628.2, 15-1628.3, 15-1629, 15-1631, 15-1633, 15-1634—15-1639, 15-2011, 15-2013(c), 15-2015, and 15-2016, Annotated Code of Maryland; Includes a definition of “multisource generic drug” that is inconsistent with COMAR 31.46, or “generic” or “brand name drug” that is inconsistent with Health Occupations Article, §12-504, Annotated Code of Maryland; Allows the PBM to reimburse a covered drug in an amount that differs, including zero, based on the identity of the wholesale distributor used by a contracting pharmacy for acquisition of the covered drug; Except for instances of error or fraud, allows a PBM or PSAO to re-classify, re-categorize, or re-characterize an adjudicated claim; In any way prohibits or restricts a pharmacist or pharmacy from filing a complaint with the Commissioner; and Fails to include the internal appeal provisions in the contract. No provisions If a PSAO uses a contract or amendment that becomes effective and the contract or amendment is subsequently found by the Commissioner to be noncompliant, the Commissioner may: Issue an order that: Gives notice of the disapproval; States a reason for the disapproval; and States the effective date of the disapproval in the notice; and Impose a civil penalty as provided under Insurance Article, §15-2019, Annotated Code of Maryland. An order under this regulation is subject to a hearing under Insurance Article, §2-210, Annotated Code of Maryland. A request for a hearing under this regulation does not stay that portion of the order that requires a PSAO to cease and desist from the conduct identified in the order Insurance Article, §§2-109, 15-2010, 15-2011, 15-2013, 15-2015, and 15-2016, Annotated Code of Maryland Effective date: December 26, 2022 (49:26 Md. R. 1081)