Chapter 48 Pharmacy Benefits Managers — Informational Filing of Contracts and Amendments

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Title 31 MARYLAND INSURANCE ADMINISTRATION

Subtitle 10 HEALTH INSURANCE — GENERAL

Chapter 48 Pharmacy Benefits Managers — Informational Filing of Contracts and Amendments

Code of Maryland Regulations

Chapter 48 Pharmacy Benefits Managers — Informational Filing of Contracts and Amendments

Administrative History 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) Regulation .04A amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .05A amended effective February 7, 2022 (49:3 Md. R. 141) Authority Insurance Article, §§ 2-109 , 12-203 (d)( 2 ), 15-1628 , and 15-1642 , Annotated Code of Maryland

.01 Applicability and Scope. This chapter applies to the submission of any participating pharmacy contract or amendment required to be filed under Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland .

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Maryland Insurance Administration. (2) “Commissioner” means the Maryland Insurance Commissioner. (3) “Noncompliant” means a contract or amendment that is not in compliance with Maryland statutes and regulations. (4) “Participating pharmacy contract” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland . (5) “Working day” means any day that the Maryland Insurance Administration is open for business.

.03 Submission Requirements. A. Pursuant to the requirements of Insurance Article, §15-1628(b), Annotated Code of Maryland , a PBM shall submit to the Commissioner as an informational filing each participating pharmacy contract form and each amendment to a contract form at least 30 days before the contract form or amendment to the contract form is to become effective. B. The Commissioner is not required to review the informational filing to evaluate whether a contract form or amendment to a contract form is in violation of Maryland law at the time the informational filing is made. C. Unless it is disapproved by the Commissioner, a PBM may use a contract form or amendment to a contract form after it has been filed with the Commissioner and 30 days have passed since the filing was acknowledged by the Commissioner in writing as having been received. D. A PBM may not file a contract form or amendment form that has been previously disapproved by the Commissioner. E. Nothing in this regulation shortens the time period for notice under Insurance Article, §15-1628(a), Annotated Code of Maryland , which requires a PBM to provide at least 30 working days’ notice before any contract change. F. The filing shall include a cover letter which includes the following: (1) A list of the contract forms and amendment forms included in the submission; and (2) A brief description of the purpose of each contract form and amendment form included in the submission. G. 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 the first page, and no other number shall appear in close proximity to the form number. H. A filing made under this chapter shall include a signed certification from a responsible officer of the PBM that, to the best of the officer’s knowledge and belief, the contract forms and amendment forms comply with applicable statutes and regulations. I. A PBM may not file a contract form or amendment form before the PBM has successfully registered as a PBM with the Commissioner.

.04 Noncompliant Contract Terms. A. A PBM may have a contract form or amendment to a contract form disapproved at any time after the contract form or amendment to a contract form has been submitted as part of an informational filing if the contract form or amendment form contains or uses any language that: (1) Violates Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland , or any applicable statutory provisions, including but not limited to Insurance Article, §§ 15-112 , 15-112 .2(a)—(e), 15-123(d), 15-1004, 15-1005, 15-1008(c), 15-1009, 15-1628—15-1628.3, 15-1629, 15-1631, and 15-1633—15-1639, and Health-General Article, §§19-710(s) and (t) and 19-712.2, Annotated Code of Maryland; (2) Does not disclose the components of the compensation program through which a reimbursement rate is set; (3) Includes a definition of “multisource generic drug” that is inconsistent with COMAR 31.10.46 , or “generic” or “brand name drug” that is inconsistent with Health Occupations Article, §12-504, Annotated Code of Maryland ; (4) 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; (5) Except for instances of error or fraud, allows the PBM to reclassify, recategorize, or recharacterize an adjudicated claim; (6) In any way prohibits or restricts a pharmacist or pharmacy from filing a complaint with the Commissioner; or (7) Fails to include the internal appeal provisions in the contract. B. No provisions in Insurance Article, Annotated Code of Maryland , or this chapter may be waived or modified by contract.

.05 Use of Noncompliant Contract or Amendment. A. If a PBM uses a contract form or amendment form which becomes effective and the contract form or amendment form is subsequently found by the Commissioner to be noncompliant, the Commissioner may: (1) Issue an order that: (a) Gives notice of the disapproval; (b) States a reason for the disapproval; and (c) States the effective date of the disapproval in the notice; and (2) Impose a penalty as provided under Insurance Article, §15-1642, Annotated Code of Maryland . B. An order under this regulation is subject to a hearing under Insurance Article, §2-210, Annotated Code of Maryland . C. A request for a hearing under this regulation does not stay that portion of the order that requires a PBM to cease and desist from the conduct identified in the order.

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