On September 23, 2024, the U.S. Departments of Labor, the Treasury, and Health and Human Services (collectively, the “Departments”) released final rules (the “Final Rules”) that implement requirements under the Mental Health Parity and Addiction Equity Act (MHPAEA).

The primary focus of the Final Rules is to implement new statutory requirements under the Consolidated Appropriations Act of 2021, which amended MHPAEA to require health plans and issuers to develop comparative analyses to determine whether nonquantitative treatment limitations (NQTLs)—which are non-financial restrictions on health care benefits that can limit the length or scope of treatment—for mental health and substance use disorder (MH/SUD) benefits are comparable to and applied no more stringently than NQTLs for medical/surgical (M/S) benefits.

Last month, Epstein Becker Green published an Insight entitled “Mental Health Parity: Federal Departments of Labor, Treasury, and Health Release Landmark Regulations,” which provides an overview of the Final Rules. This Insight takes a closer look at the application of the Final Rules to NQTLs related to provider network composition and reimbursement rates.

Provider Network Composition and Reimbursement NQTL Types

A key focus of the Final Rules is to ensure that NQTLs related to provider network composition and reimbursement rates do not impose greater restrictions on access to MH/SUD benefits than they do for M/S benefits.

In the Final Rules, the Departments decline to specify which strategies and functions they expect to be analyzed as separate NQTL types, instead requiring health plans and issuers to identify, define, and analyze the NQTL types that they apply to MH/SUD benefits. However, the Final Rules set out that the general category of “provider network composition” NQTL types includes, but is not limited to, “standards for provider and facility admission to participate in a network or for continued network participation, including methods for determining reimbursement rates, credentialing standards, and procedures for ensuring the network includes an adequate number of each category of provider and facility to provide services under the plan or coverage.”[1]

For NQTLs related to out-of-network rates, the Departments note that NQTLs would include “[p]lan or issuer methods for determining out-of-network rates, such as allowed amounts; usual, customary, and reasonable charges; or application of other external benchmarks for out-of-network rates.”[2]

Requirements for Comparative Analyses and Outcomes Data Evaluation

For each NQTL type, plans must perform and document a six-step comparative analysis that must be provided to federal and state regulators, members, and authorized representatives upon request. The Final Rules divide the NQTL test into two parts: (1) the “design and application” requirement and (2) the “relevant data evaluation” requirement.

The “design and application” requirement, which builds directly on existing guidance, requires the “processes, strategies, evidentiary standards, or other factors” used in designing and applying an NQTL to MH/SUD benefits to be comparable to, and applied no more stringently than, those used for M/S benefits. Although these aspects of the comparative analysis should be generally familiar, the Final Rules and accompanying preamble provide extensive new guidance about how to interpret and implement these requirements.

The Final Rules also set out a second prong to the analysis: the requirement to collect and evaluate “relevant data” for each NQTL. If such analysis shows a “material difference” in access, then the Final Rules also require the plan to take “reasonable” action to remedy the disparity.

The Final Rules provide that relevant data measures for network composition NQTLs may include, but are not limited to:

• in-network and out-of-network utilization rates, including data related to provider claim submissions;
• network adequacy metrics, including time and distance data, data on providers accepting new patients, and the proportions of available MH/SUD and M/S providers that participate in the plan’s network; and
• provider reimbursement rates for comparable services and as benchmarked to a reference standard, such as Medicare fee schedules.

Although the Final Rules do not describe relevant data for out-of-network rates, these data measures may parallel measures to evaluate in-network rates, including measures that benchmark MH/SUD and M/S rates against a common standard, such as Medicare fee schedule rates.

Under the current guidance, plans have broad flexibility to determine what measures must be used, though the plan must ensure that the metrics that are selected reasonably measure the actual stringency of design and application of the NQTL with regard to the impact on member access to MH/SUD and M/S benefits. However, additional guidance is expected to further clarify the data evaluation requirements that may require the use of specific measures, likely in the form of additional frequently asked questions as well as updates to the Self-Compliance Tool published by the Departments to help plans and issuers assess whether their NQTLs satisfy parity requirements.

The Final Rules require plans to look at relevant data for network composition NQTLs in the aggregate—meaning that the same relevant data must be used for all NQTL types (however defined). As such, the in-operation data component of the comparative analysis for network composition NQTLs will be aggregated.

If the relevant data indicates a “material difference,” the threshold for which the plan must establish and define reasonably, the plan must take “reasonable actions” to address the difference in access and document those actions.

Examples of a “reasonable action” that plans can take to comply with network composition requirements “include, but are not limited to:

1. Strengthening efforts to recruit and encourage a broad range of available mental health and substance use disorder providers and facilities to join the plan’s or issuer’s network of providers, including taking actions to increase compensation or other inducements, streamline credentialing processes, or contact providers reimbursed for items and services provided on an out-of-network basis to offer participation in the network;
2. Expanding the availability of telehealth arrangements to mitigate any overall mental health and substance use disorder provider shortages in a geographic area;
3. Providing additional outreach and assistance to participants and beneficiaries enrolled in the plan or coverage to assist them in finding available in-network mental health and substance use disorder providers and facilities; and
4. Ensuring that provider directories are accurate and reliable.”

These examples of potential corrective actions and related discussion in the Final Rules provide an ambitious vision for a robust suite of strategies that the Departments believe that plans should undertake to address material disparities in access as defined in the relevant data. However, the Final Rules put the onus on the plan to design the strategy that it will use to define “material differences” and remedy any identified disparity in access. Future guidance and enforcement may provide examples of how this qualitative assessment will play out in practice and establish both what the Departments will expect with regard to the definition of “material differences” and what remedial actions they consider to be sufficient. In the interim, it is highly uncertain what the practical impact of these new requirements will be.

Examples of Network Analyses Included in the Final Rules

The Final Rules include several examples to clarify the application of the new requirements to provider network composition NQTLs. Unfortunately, the value of these examples for understanding how the Final Rules will impact MH/SUD provider networks in practice may be limited. As a result, given the lack of detail regarding the complexity of analyzing these requirements for actual provider networks, as well as the fact that the examples fail to engage in any meaningful discussion of where to identify the threshold for compliance with these requirements, it remains to be seen how regulators will interpret and enforce these requirements in practice.

• Example 1 demonstrates that it would violate the NQTL requirements to apply a percentage discount to physician fee schedule rates for non-physician MH/SUD providers if the same reduction is not applied for non-physician M/S providers. Our takeaways from this example include the following:
  • This example is comparable to the facts that were alleged by the U.S. Department of Labor in Walsh v. United Behavioral Health, E.D.N.Y., No. 1:21-cv-04519 (8/11/21).
  • Example 1 is useful to the extent that it clarifies that a reimbursement strategy that specifically reduces MH/SUD provider rates in ways that do not apply to M/S provider rates would violate MHPAEA. However, such cut-and-dried examples may be rare in practice, and a full review of the strategies for developing provider reimbursement rates is necessary.
• Example 4 demonstrates that plans may not simply rely on periodic historic fee schedules as the sole basis for their current fee schedules. Here are some key takeaways from this example:
  • Even though this methodology may be neutral and non-discriminatory on its face, given that the historic fee schedules are not themselves a non-biased source of evidence, to meet the new requirements for evidentiary standards and sources, the plan would have to demonstrate that these historic fee schedules were based on sources that were objective and not biased against MH/SUD providers.
  • If the plan cannot demonstrate that the evidentiary standard used to develop its fee schedule does not systematically disfavor access to MH/SUD benefits, it can still pass the NQTL test if it takes steps to cure the discriminatory factor.
  • Example 4 loosely describes a scenario where a plan supplements a historic fee schedule that is found to discriminate against MH/SUD access by accounting for the current demand for MH/SUD services and attracting “sufficient” MH/SUD providers to the network. Unfortunately, however, the facts provided do not clarify what steps were taken to achieve this enhanced access or how the plan or regulator determined that access had become “sufficient” following the implementation of the corrective actions.
• Example 10 provides that if a plan’s data measures indicate a “material difference” in access to MH/SUD benefits relative to M/S benefits that are attributable to these NQTLs, the plan can still achieve compliance by taking corrective actions. Our takeaways from this example include the following:
  • The facts in this example stipulate that the plan evaluates all of the measure types that are identified above as examples. Example 10 also states that a “material difference” exists but does not identify the measure or measures for which a difference exists or what facts lead to the conclusion that the difference was “material.” To remedy the material difference, this example states that the plan undertakes all of the corrective actions to strengthen its MH/SUD provider network that are identified above as examples and, therefore, achieves compliance. However, this example fails to clarify how potentially inconsistent outcomes across the robust suite of identified measures were balanced to determine that the “material difference” standard was ultimately met. Example 10 also does not provide any details about what specific corrective actions the plan takes or what changes result from these actions.

Epstein Becker Green’s Perspective

The new requirements of the Final Rules will significantly increase the focus of the comparative analyses on the outcomes of the provider network NQTLs. For many years, the focus of the comparative analyses was primarily on determining whether any definable aspect of the plan’s provider contracting and reimbursement rate-setting strategies could be demonstrated to discriminate against MH/SUD providers. The Final Rules retain those requirements but now put greater emphasis on the results of network composition activities with regard to member access and require plans to pursue corrective actions to remediate any material disparities in that data. This focus on a robust “disparate impact” form of anti-discrimination analysis may lead to a meaningful increase in reimbursement for MH/SUD providers or other actions to more aggressively recruit them to participate in commercial health plan networks.

However, at present, it remains unclear which measures the Departments will ultimately require for reporting. Concurrent with the release of their Notice of Proposed Rulemaking on July 23, 2023, the Departments published Technical Release 2023-01P to solicit comments on key approaches to evaluating comparability and stringency for provider network access and reimbursement rates (including some that are referenced as examples in the Final Rules). Comments to the Technical Release highlighted significant concerns with nearly all of the proposed measures. For example, proposals to require analysis of MH/SUD and M/S provider reimbursement rates for commercial markets that are benchmarked to Medicare fee schedules in a simplistic way may fail to account for differences in population health and utilization, value-based reimbursement strategies, and a range of other factors with significant implications for financial and clinical models for both M/S and MH/SUD providers. Requirements to analyze the numbers or proportions of MH/SUD and M/S providers that are accepting new patients may be onerous for providers to report on and for plans to collect and may obscure significant nuances with regard to wait times, the urgency of the service, and the match between the provider’s training and service offerings to the patient’s need. Time and mileage standards highlighted by the Departments not only often fail to capture important access challenges experienced by patients who need MH/SUD care from sub-specialty providers or facilities but also fail to account for evolving service delivery models that may include options such as mobile units, school-based services, home visits, and telehealth. Among the measures identified in the Technical Release, minor differences in measure definitions and specifications can have significant impacts on the data outcomes, and few (if any) of the proposed measures have undergone any form of testing for reliability and validity.

Also, it is still not clear where the Departments will draw the lines for making final determinations of noncompliance with the Final Rules. For example, where a range of different data measures is evaluated, how will the Departments resolve data outcomes that are noisy, conflicting, or inconclusive? Similarly, where regulators do conclude that the data that are provided suggest a disparity in access, the Final Rules identify a highly robust set of potential corrective actions. However, it remains to be seen what scope of actions the Departments will determine to be “good enough” in practice.

Finally, we are interested in seeing what role private litigation will play in driving health plan compliance efforts and practical impacts for providers. To date, plaintiffs have found it challenging to pursue litigation on the basis of claims under MHPAEA, due in part to the highly complex arguments that must be made to evaluate MHPAEA compliance and in part to the challenge for plaintiffs to have adequate insight into plan policies, operations, and data across MH/SUD and M/S benefits to adequately assert a complaint under MHPAEA. Very few class action lawsuits or large settlements have occurred to date. These challenges for potential litigants may continue to limit the volume of litigation. However, to the extent that the additional guidance in the Final Rules does give rise to an uptick in successful litigation, it is possible that the courts may end up having a greater impact on health plan compliance strategies than regulators.

ENDNOTES

[1] 26 CFR 54.9812- 1(c)(4)(ii)(D), 29 CFR 2590.712(c)(4)(ii)(D), and 45 CFR 146.136(c)(4)(ii)(D).

[2] 26 CFR 54.9812- 1(c)(4)(ii)(E), 29 CFR 2590.712(c)(4)(ii)(E), and 45 CFR 146.136(c)(4)(ii)(E).

©2024 Epstein Becker & Green, P.C. All rights reserved. by: Kevin J. Malone, Jackie Selby, David Shillcutt, Christine Burke Worthen of Epstein Becker & Green, P.C. For more on Mental Health, visit the NLR Health Law Managed Care section