Mental Health Parity: Final Rules Issued on NQTLs
On September 9, 2024, the U.S. Department of the Treasury, Department of Labor and Department of Health & Human Services (collectively, "the Departments") released final rules further clarifying and implementing requirements related to the Mental Health Parity and Addiction Equity Act (MHPAEA), and non-quantitative treatment limitations (NQTLs). These final rules add further requirements for completing a comparative analysis of NQTLs and set specific requirements for achieving parity for network composition.
The final rules apply to group health plans beginning in 2025, except that the more significant changes related to the meaningful benefits standard, the prohibition on discriminatory factors and evidentiary standards, and relevant data evaluation requirements (along with associated content requirements in the comparative analysis) will not go into effect until plan years beginning in 2026. In the meantime, however, the Departments emphasize that plans are already subject to MHPAEA requirements as set forth in the 2013 final regulations as well as the comparative analysis requirements added by the Consolidated Appropriations Act of 2021, and should comply accordingly while working toward bringing plans into compliance with these latest requirements by 2026.
BACKGROUND
MHPAEA requires group health plans offering mental health and substance use disorder (MH/SUD) benefits to provide such benefits “in parity” with (equal to or better than) the medical/surgical coverage available under the group health plan. MHPAEA does not require group health plans to provide MH/SUD benefits, but if the plan does offer such benefits beyond what is considered preventive under the Affordable Care Act (ACA), the parity requirements apply. MHPAEA applies to both fully-insured and self-funded group health plans, but not to excepted benefits or retiree-only plans.
If a group health plan provides medical/surgical benefits and MH/SUD benefits, the plan’s MH/SUD benefits are subject to the following parity requirements (as compared to the plan’s medical/surgical benefits):
- Same or more generous annual/lifetime limits;
- Equal financial requirements and quantitative treatment limitations; and
- Equal treatment for NQTLs (e.g., prior authorization, medical necessity, provider network standards, fail first or step therapy policies, experimental treatment limitations, etc.).
The parity of any financial requirements or treatment limitations is determined on a classification-by-classification basis for six different classifications, as seen in the table below. Plans must provide MH/SUD benefits in parity for all classifications in which medical/surgical benefits are available.
*Outpatient services may be sub-classified into (a) office visits and (b) all other outpatient items and services but plans generally cannot further sub-classify generalists and specialists.
Finally, specific to NQTLs, plans must evaluate and document the parity of any NQTLs applicable to MH/SUD benefits, as written and in operation, via a comparative analysis. The comparative analysis must be kept current and made available upon request by federal or state agencies as well as by ERISA plan participants.
MEANINGFUL BENEFITS
The final rules clarify that if a plan provides any benefits for a specific MH/SUD, the plan must provide “meaningful benefits” for that condition or disorder in every classification in which medical/surgical benefits are provided. To satisfy this requirement, a plan must provide core treatment for that specific condition or disorder in each classification in which the plan provides benefits for a core treatment for medical conditions or surgical procedures. “Core treatment” is defined as “a standard treatment or course of treatment, therapy, service, or intervention indicated by generally recognized independent standards of current medical practice.” Examples in the final regulations address how this new requirement may apply to applied behavioral analysis (ABA) therapy for autism spectrum disorder, nutritional counseling for eating disorders, and coverage of medications to treat opioid use disorders.
NEW REQUIREMENTS FOR NQTLS
NQTLs are permitted for MH/SUD benefits if (1) they are no more stringent than those applied to medical/surgical benefits, or (2) they are consistent with generally recognized independent professional medical clinical standards or standards related to fraud, waste and abuse. To ensure these general requirements are met, NQTLs must meet certain design and application and relevant data evaluation requirements. Also, the final rules clarify that a plan may not impose any NQTL on MH/SUD benefits if that specific NQTL does not also apply to medical/surgical benefits in the same classification.
Design and Application Requirement
A plan may not impose an NQTL for MH/SUD benefits in any classification unless any processes, strategies, evidentiary standards, or other factors used in designing and applying the NQTL to MH/SUD benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in designing and applying the limitation with respect to medical/surgical benefits.
A plan cannot rely upon discriminatory (biased or not objective) factors or evidentiary standards to design a NQTL for MH/SUD benefits. The regulations note that historical plan data or other historical information from a time when the plan or coverage was not subject to or was not in compliance with MHPAEA is generally biased or not objective, if the historical plan data or other historical information systematically disfavor access or are specifically designed to disfavor access to mental health or substance use disorder benefits as compared to medical/surgical benefits, and the plan has not taken the steps necessary to correct, cure, or supplement the data or information. On the other hand, generally recognized independent professional medical or clinical standards and carefully circumscribed measures reasonably and appropriately designed to detect or prevent and prove fraud and abuse that minimize the negative impact on access to appropriate MH/SUD benefits are not biased and are objective.
Relevant Data Evaluation Requirement
The plan must collect and evaluate relevant data (e.g., number and percentage of claims denials, network utilization, network adequacy metrics, provider reimbursement rates) to assess the application of a NQTL and how it impacts access to MH/SUD benefits. If there are material differences in access to MH/SUD benefits in comparison to medical/surgical benefits, the plan must take reasonable action as necessary to address any material differences in access. For example, within a classification, similar medical management techniques may apply to medical/surgical benefits and mental health benefits; however, if after analyzing the percentage of claims denied, the data shows mental health benefit claims being denied at a much larger percentage than medical/surgical benefits, the plan may need to make adjustments.
Specific to network composition, the plan must collect and evaluate relevant data to assess the aggregate impact of NQTLs on access to benefits. The rules suggest certain actions that could be taken if material differences in access are discovered related to network composition (e.g., recruit and encourage more network participation, expand telehealth, assist plan participants in finding in-network care, keep provider directories current).
UPDATED REQUIREMENTS FOR COMPARATIVE ANALYSES
Group health plan sponsors are required to prepare a comparative analysis documenting compliance for any NQTLs. The final rules clarify existing content requirements, providing much more detail about what is expected to be evaluated and included in the written analysis, and then also requires plans to include an evaluation of relevant data. Specifically, for each NQTL applicable to MH/SUD benefits, the written comparative analysis must contain the following content:
- Description of the NQTL, which benefits are subject to the NQTL, and which benefits are in which classification;
- List and definitions for any factors and evidentiary standards used to design or apply the NQTL;
- Description of how factors are used in the design and application of the NQTL;
- Demonstration of comparability and stringency of the NQTL, as written;
- Demonstration of comparability and stringency of the NQTL, in operation, including any material differences in access and reasonable action taken to address the material differences;
- Findings and conclusions, including the date the analysis was completed and the title and credentials of persons involved in preparing the comparative analysis.
Due to the amount of detail and the number of sources of information that must be analyzed, a thorough, compliant analysis cannot be quickly pulled together within the timeframe required to comply with a request from an agency or plan participant. It is necessary for employers to complete it and have it ready and on file prior to any request.
Fiduciary Certification
To further enforce awareness of compliance requirements, for plans subject to ERISA, the final rules require that the comparative analysis include a certification by one or more named fiduciaries. The fiduciaries must certify that they “engaged in a prudent process to select one or more qualified service providers to perform and document a comparative analysis…and have satisfied their duty to monitor those service providers…” In other words, plan fiduciaries do not have to certify full compliance with MHPAEA, but instead must certify and take responsibility for due diligence in selecting a service provider that can provide what is needed to comply with MHPAEA.
Non-Compliance
For plans that fail to provide a complete and thorough comparative analysis and then fail to correct any insufficiencies within the timeframe required by the applicable agency, the agencies may direct the plan not to impose any NQTL that cannot be adequately shown to be in parity with medical/surgical benefits. In addition, the plan (or sponsoring employer) may be listed in the agencies’ enforcement report to Congress and may have to notify plan participants with something similar to the following:
“Attention! The [Department of Labor/Department of Health and Human Services/Department of the Treasury] has determined that [insert the name of group health plan or health insurance issuer] is not in compliance with the Mental Health Parity and Addiction Equity Act.”
The notice would need to include a summary of the agency’s finding of non-compliance and information about how participants can obtain a copy, information for where to direct any questions or complaints, and contact information for the applicable agency. The notice would also be required to include a summary of any changes the plan has made as part of its corrective action plan, including an explanation of any opportunity for a participant to have a claim for benefits reprocessed.
In addition to the potential consequences discussed above for failure to provide a complete comparative analysis when requested by a federal or state agency, for ERISA plans, there is risk of civil penalties for failure to provide the analysis within 30 days of request by a plan participant or beneficiary.
EMPLOYER ACTION
The MHPAEA requirements, including the plan design and administration requirements as well as the written comparative analysis, can be complex to navigate and implement. Most employers do not have the expertise needed to design a group health plan as required, are not directly involved in claims processing, and do not have access to the level of information needed to prepare a sufficient comparative analysis. Therefore, employers must rely heavily on carriers, TPAs and other service providers to offer a compliant plan design, to properly administer claims, and to evaluate and document compliance in a detailed comparative analysis.
For fully-insured plans, the carrier is directly responsible for compliance. Employers with fully-insured plans should follow up with their group health carriers to confirm that a current comparative analysis is on file, and will be provided should the employer be contacted by state or federal regulators.
For self-funded plans, the employer is primarily responsible for compliance and will need to take efforts to ensure that TPAs, PBMs and other service providers involved in designing and administering the plan on the employer’s behalf are competent and willing to comply with the MHPAEA requirements and to (1) prepare a comparative analysis on behalf of the plan, and/or (2) provide the data needed for another vendor to prepare the comparative analysis.
Since the creation of the comparative analysis requirement, Keenan has worked with several vendors and our self-funded clients to ensure that all the relevant data is shared by network service providers, TPAs and PBMs so that a fully compliant comparative analysis can be completed. The vendors with which we have worked with have already included the requirements of the final rule into their workflows. What is clear, based on these rules, is that self-funded plans should now ensure that they have a current comparative analysis on file.
ADDITIONAL RESOURCES
Keenan is not a law firm and no opinion, suggestion, or recommendation of the firm or its employees shall constitute legal advice. Clients are advised to consult with their own attorney for a determination of their legal rights, responsibilities, and liabilities, including the interpretation of any statute or regulation, or its application to the clients’ business activities.
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