The purpose of this chapter is to adopt regulations to implement Insurance Article, §15-144, Annotated Code of Maryland, to ensure uniform definitions and methodology for the reporting requirements established under this chapter. This chapter applies to carriers that deliver or issue for delivery a health benefit plan in Maryland. In this chapter, the following terms have the meaning indicated. Terms Defined. “Analysis report” means the report required by Insurance Article, §15-144(c)(2), Annotated Code of Maryland. “As written” means the written policies, procedures, and related documents, including medical necessity criteria or guidelines, used in the development and description of a NQTL and the decision whether to apply a NQTL to a particular benefit by the carrier or any entity delegated by the carrier to manage mental health, substance use disorder, or medical/surgical benefits on behalf of the carrier. “Evidentiary standards” has the meaning stated in 45 C.F.R. §146.136(a). “Factor” has the meaning stated in 45 C.F.R. §146.136(a). “In operation” means as used in the implementation and application of NQTLs, including the administration of benefits. “Medical/surgical benefits” has the meaning stated in Insurance Article, §15-144(a)(4), Annotated Code of Maryland, and may be abbreviated as “med/surg benefits” or “M/S benefits”. “Medical Necessity” means medical necessity as determined by the definition, criteria, or guidelines used by the carrier or its private review agent to determine what is necessary, efficient, or appropriate for purposes of coverage of a service or benefit. Insurance Article, §15-802, Annotated Code of Maryland, requires use of the criteria published by the American Society of Addiction Medicine for the evaluation of the medical necessity, efficiency, or appropriateness of services to treat a substance use disorder. “Mental health benefits” has the meaning stated in Insurance Article, §15-144(a)(5), Annotated Code of Maryland. “MH/SUD” means mental health benefits and substance use disorder benefits as a combined category. “NQTL” means a nonquantitative treatment limitation as defined in Insurance Article, §15-144(a)(6), Annotated Code of Maryland. “Parity Act” has the meaning stated in Insurance Article, §15-144(a)(7), Annotated Code of Maryland. “Parity Act classification” has the meaning stated in Insurance Article, §15-144(a)(8), Annotated Code of Maryland. “Process” has the meaning stated in 45 C.F.R. §146.136(a). “Product” has the meaning stated in Insurance Article, §15-1309(a)(3), Annotated Code of Maryland. “Provider” means: A physician; Hospital; Facility; Practitioner; or Other person who is licensed or otherwise authorized to provide healthcare services. “Source” means the data, analyses, recommendation, requirement, meeting, or other information upon which a factor is based or from which a factor is derived or arises. “Strategy” has the meaning stated in 45 C.F.R. §146.136(a). “Substance use disorder benefits” has the meaning stated in Insurance Article, §15-144(a)(9), Annotated Code of Maryland. “Summary form” means the form required by Insurance Article, §15-144(g)(5), Annotated Code of Maryland. For each product offered by the carrier in the individual, small, and large group markets, a carrier that delivers or issues for delivery a health benefit plan in the State shall file a comparative analysis for each nonquantitative treatment limitation selected by the Commissioner in accordance with Insurance Article, §15-144 (c)(5), Annotated Code of Maryland, in the form required by the Commissioner, to demonstrate the carrier’s compliance with the Parity Act, in accordance with Insurance Article, §15-144(c)—(e), and (g), Annotated Code of Maryland. An analysis report shall be filed with the Commissioner using only the form developed by the Commissioner and posted on the Administration’s website. If, for any plan within a product described in §A of this regulation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the selected NQTLs to MH/SUD benefits and M/S benefits are different, as written or in operation, from the other plans within the product, the carrier shall submit a separate comparative analysis for the selected NQTLs for the plan, and the statement required by Insurance Article, §15-144(c)(3)(iii) shall note the exception and identify the plan. A carrier shall submit the data templates described in Insurance Article, §15-144(f), Annotated Code of Maryland, in the form required by the Commissioner. The analysis reports described in §§A—C of this regulation shall be submitted on or before July 1, 2024, and every 2 years thereafter. Carriers shall prepare the analysis report in coordination with any entity the carrier contracts with to provide, manage, or administer MH/SUD benefits. Carriers shall follow the instructions posted on the Administration's website to complete the analysis report. A complete analysis report shall include responses to each section of the standardized form, as described in the instructions posted on the Administration's website. Each analysis report shall contain the statements required by Insurance Article, §15-144(c)(3)(iii) and (g)(4), Annotated Code of Maryland. Failure to file a complete analysis report shall constitute noncompliance with the Parity Act and the Commissioner will have authority to act in accordance with the provisions of Insurance Article, §15-144 (j), Annotated Code of Maryland. Complete Analysis Report. The analysis required by Insurance Article, §15-144(d), Annotated Code of Maryland, shall have been performed for NQTLs in place during the calendar year preceding the analysis report. A carrier shall analyze each NQTL separately for each classification and sub-classification, as applicable, of benefits. If the carrier delegates administration or management of mental health, substance use disorder, or medical/surgical benefits to another entity (for example, a private review agent specializing in mental health and substance use disorder benefits or a pharmacy benefits manager), the analyses shall be conducted with close and coordinated involvement of both the carrier and the entity delegated by the carrier to manage mental health, substance use disorder, or medical/surgical benefits on behalf of the carrier. The carrier is responsible for providing all required information for the analyses, regardless of any delegation arrangement with a subcontracted entity. The analysis reports shall include the following information to be considered complete: All of the information identified in Insurance Article, §15-144(d)-(f), Annotated Code of Maryland, in the manner and format specified in the standard reporting form and associated instructions provided on the Administration’s website; A response to each step listed in the reporting form, for each NQTL selected in accordance with Insurance Article, §15-144 (c)(5), Annotated Code of Maryland in each classification and sub-classification, as applicable. If a particular item in a step is not applicable (for example, if none of the factors used to determine that the NQTL will apply to a benefit was given more weight than another), an explanation shall be provided as to why the item is not applicable; A statement as to whether there is any variation in the design or application of a guideline or standard used by the carrier between MH/SUD and medical/surgical benefits, and, if so, a description of the factors and process used for establishing that variation. Specific definitions of factors, processes, or criteria used to establish or support any variation is required. Any practice guidelines that may be associated with the NQTL shall also be provided; If the design or application of the NQTL turns on specific decisions in the administration of the benefits, identification of the basis of the decisions, the decision maker or makers, the timing of the decisions, and the qualifications of the decision maker or makers, including expertise and specialty; If the analyses rely upon any experts, an assessment of each expert's qualifications, expertise and specialty, and a description of the extent to which the carrier relied upon each expert's evaluations in setting recommendations regarding both MH/SUD and medical/surgical benefits. Any variation in the use of experts (for example, specialty matching, licensure levels, etc.) for MH/SUD compared to M/S shall be defined and justified; A description of all exception processes available for each NQTL and when the exception may be applied; An explanation of how much discretion is allowed in applying the NQTL and whether such discretion is afforded comparably for processing MH/SUD benefit claims and medical/surgical benefits claims; Documentation of audits, reviews, and analyses to check sample claims or other administrative data to assess how each NQTL operates in practice, and whether written processes are correctly carried out, including the results of the audits and reviews performed on the NQTLs selected in accordance with Insurance Article, §15-144(c)(5), Annotated Code of Maryland, to conduct the comparative analysis required under Insurance Article, §15-144 (d)(2), Annotated Code of Maryland, as written, and in operation; Citations to any documents, studies, testing, claims data, or reports that include factors, sources, evidentiary standards, or other evidence relied upon in developing or applying the NQTL (for example, meeting minutes or reports showing how those considerations were applied), with copies of those items available on request; and A description of the consequences or penalties that apply when the NQTL requirement is not met. A carrier subject to Insurance Article, §15-144, Annotated Code of Maryland, shall prepare a summary form using only the template form posted on the Administration’s website. The summary form shall be made available to plan members and accessible to the public on the carrier’s website no later than 30 days following the due date of each analysis report. In addition to the requirement under Insurance Article, § 15-144(c)(1)(iv), Annotated Code of Maryland that a carrier must provide the full comparative analysis to a member within 30 days of a written request, the carrier shall make the summary form available to plan members in response to a written request within 30 days of the request. Carriers shall follow the instructions for completing the summary form using the instructions posted on the Administration’s website. A complete summary form shall include responses to each applicable section of the standardized form, as described in the instructions posted on the Administration’s website. If, as a result of the review of the reports described in Regulation .04 of this chapter, the Commissioner finds that a carrier subject to Insurance Article, §15-144, Annotated Code of Maryland, failed to comply with provisions of the Parity Act, the Commissioner shall notify the carrier and require the carrier to submit a compliance plan pursuant to Insurance Article, §15-144(i), Annotated Code of Maryland, to correct the noncompliance. The notice shall be in writing, but may be transmitted electronically. The carrier shall have 90 days to file a compliance plan following the date a notice of noncompliance is issued by the Commissioner. The compliance plan shall include: An acknowledgement of the Commissioner’s finding of noncompliance; A summary of action or actions taken by the carrier to correct the noncompliance prior to the notice from the Commissioner; A summary of future action or actions to correct the noncompliance and the time frame when the actions will be taken; and A summary of amounts owed to members or providers due to violations of the Parity Act, including: Any amounts owed to members and the payment date or dates; Draft correspondence to members; Any amounts owed to providers and the payment date or dates; Draft correspondence to providers; and Confirmation of amounts paid to members and providers. This chapter is applicable to all reports filed after January 1, 2022. Insurance Article, §§2-109(a)(1) and 15-144, Annotated Code of Maryland Effective date: Effective December 27, 2021 (48:26 Md. R. 1113) Chapter revised effective October 13, 2025 (52:20 Md. R. 1003)