Tag: MHPAEA

Mental Health Parity and Addiction Equity Act Final Rules (“Final Rules”) Are Released: Plans and Issuers Must Prepare for January 1, 2025 Effective Date (US)

The long-awaited Final Rules amending the Mental Health Parity and Addiction Equity Act (“MHPAEA”) were released on September 9, 2024, with the bulk of the requirements going into effect on January 1, 2025. As we previously reported here, in August 2023, the Departments of Labor, Health and Human Services (“HHS”) and Treasury (together, the “Departments”) published proposed rules further regulating insurance coverage for treatment for mental health and substance use disorders. Although the Final Rules appear less burdensome than the proposed rules, they do impose significant changes to the obligations of group health plans and health insurance issuers with a short time to achieve compliance. The key provisions are summarized below.

Key Changes in the Final Rules

The Final Rules’ stated intent is to “strengthen consumer protections consistent with MHPAEA’s fundamental purpose,” which includes reducing burdens on access to benefits for individuals in group health plans or with group or individual health insurance coverage seeking treatment for mental health and substance use disorders (“MH/SUD”) as compared to accessing benefits for the treatment of medical/surgical (“M/S”) conditions.

The Final Rules purport to achieve that goal through four key changes to the MHPAEA:

  • Mandating content requirements for performing a comparative analysis of the design and application of each non-quantitative treatment limitation (“NQTL”) applicable to MH/SUD benefits.
  • Setting forth design and application requirements and relevant data evaluation requirements to ensure compliance with NQTL rules.
  • Increasing scrutiny of network adequacy for MH/SUD benefits.
  • Introducing core treatment coverage requirements to the meaningful benefit standard.

Comparative Analysis Content Requirements

Since 2021, insurance plans and issuers offering plans that cover both M/S and MH/SUD benefits and impose NQTLs on MH/SUD benefits must have a written comparative analysis demonstrating that the factors used to apply an NQTL to MH/SUD benefits are comparable to and applied no more stringently than those used to apply that same NQTL to M/S benefits, as set forth in the 2021 Consolidated Appropriations Act (“CAA”). The Final Rules expand upon the NQTL analysis required by the CAA and include six specific content elements:

  1. a description of the NQTL;
  2. identification and definition of the factors and evidentiary standards used to design or apply the NQTL;
  3. a description of how factors are used in the design or application of the NQTL;
  4. a demonstration of comparability and stringency, as written;
  5. a demonstration of comparability and stringency, in operation, including the required data, evaluation of that data, explanation of any material differences in access, and description of reasonable actions taken to address such differences; and
  6. findings and conclusions.

Upon request, plans and issuers must provide written comparative analyses to U.S. regulators, plan beneficiaries, participants, or enrollees who have received an adverse benefit determination related to MH/SUD benefits, and participants and beneficiaries in plans governed by ERISA at any time. Plans and issuers only have 10 business days to respond to a request from the relevant Secretary to review its comparative analyses and, if an initial determination of noncompliance is made, the plan or issuer only has 45 calendar days to respond with specific actions it will take to bring the plan into compliance and provide additional comparative analyses that demonstrate compliance. Upon a final determination of noncompliance, notice must be given to all participants, beneficiaries, and enrollees within seven business days after the relevant Secretary’s determination.

Demonstrating Compliance with NQTL Rules

The Final Rules also require that a NQTL applicable to MH/SUD benefits in a classification is no more restrictive than the predominant NQTL applied to M/S benefits in the same classification. In order to ensure compliance with NQTL rules, plans and issuers must satisfy two sets of requirements: (1) the design and application requirements, and (2) the relevant data evaluation requirements. For example, under the design and application requirements, a plan cannot reimburse non-physician providers of MH/SUD services by reducing the rates for physician providers of MH/SUD services unless it applies the same reduction to non-physician providers of M/S services from the rate for physician providers of such services. Under the relevant data evaluation requirements, to compare the impact of NQTLs related to network composition on access to MH/SUD versus M/S benefits, a plan should evaluate metrics relating to the time and distance from plan participants and beneficiaries to network providers, the number of network providers accepting new patients, provider reimbursement rates, and in-network and out-of-network utilization rates.

Design and Application

Plans and issuers must examine the factors used to design and apply an NQTL to MH/SUD benefits to ensure such factors are comparable to those used with respect to M/S benefits in the same classification. The Final Rules also prohibit using information that discriminates against MH/SUD benefits as compared to M/S benefits, meaning information that systematically disfavors or was specifically designed to disfavor access to MH/SUD benefits. Appropriate information and other factors to use in designing and applying an NQTL to MH/SUD benefits include generally recognized independent professional medical or clinical standards.

Relevant Data Evaluation

The relevant data evaluation requirement means plans and issuers must collect and evaluate data to ensure, in operation, that an NQTL applicable to MH/SUD benefits is not more restrictive than the NQTL applied to M/S benefits in the same classification. The Final Rules anticipate that the relevant data for any given NQTL will depend on the facts and circumstances and provide flexibility for plans to determine what should be collected and evaluated. Examples of relevant data provided in the Final Rules include the number and percentage of claim denials, utilization rates, and network adequacy rates.

Network Adequacy

The Final Rules demonstrate the Departments’ increased scrutiny of network adequacy issues for MH/SUD benefits. For NQTLs related to network composition standards, a plan or issuer must collect data to assess the NQTLs’ aggregate impact on access to MH/SUD benefits and M/S benefits. By way of example, suppose the evaluated data suggests that an NQTL contributes to a material difference in access to MH/SUD benefits compared to M/S benefits. In that case, plans and issuers must act to address any material differences in access. The Final Rules provide examples of reasonable compliance actions, including increased recruiting efforts for MH/SUD providers, expanding telehealth options under the plan, and ensuring that provider directories are accurate and reliable. A plan must document the actions that it takes to address differences in access to in-network MH/SUD providers as compared to in-network M/S providers.

Meaningful Benefit Standard

The Final Rules require plans to provide “meaningful” benefits for MH/SUD disorders in every classification in which the plan provides M/S benefits. Benefits are “meaningful,” for MHPAEA purposes, when they cover core treatments for that condition, meaning a standard treatment or course of treatment, therapy, service, or intervention indicated by generally recognized independent standards of current medical practice.

The Final Rules provide examples to demonstrate the application of the meaningful benefits standard. In one example, a plan covers the full range of outpatient treatments (including core treatments) and treatment settings for M/S benefits when provided on an out-of-network basis. The same plan covers outpatient, out-of-network developmental screenings for a mental health condition but excludes all other benefits, such as therapeutic intervention, for outpatient treatment when provided on an out-of-network basis. The Departments view therapeutic intervention, however, as a core treatment for the mental health condition under generally recognized independent standards of current medical practice. Per the Final Rules, the Departments interpret such exclusion as a violation because the plan does not cover a core treatment for the mental health disorder in the outpatient, out-of-network classification. Since the plan’s coverage for M/S benefits includes a core treatment in the classification, the Final Rules opine that the plan fails to provide meaningful benefits for treatment of the mental health disorder.

Effective Dates

The new requirements of the Final Rules will go into effect on different dates. Plans and issuers have until January 1, 2026, to comply with the meaningful benefits standard, the prohibition on discriminatory factors and evidentiary standards, the relevant data evaluation requirements, and the related requirements in the provisions for comparative analyses. During this time, plans and issuers should assess whether their mental health provider networks are adequate, and also consider expanding the scope of MH/SUD benefits across classifications to meet new parity requirements.

The other requirements, including most of the new requirements affecting comparative analyses, go into effect on January 1, 2025. Accordingly, plans and issuers should the time remaining this year to develop a plan to prepare NQTL comparative analyses within the three-month compliance period, and have processes in place to quickly address any material changes to benefit design in the future.

© Copyright 2024 Squire Patton Boggs (US) LLP
For more on MHPAEA, visit the NLR Health Law Managed Care section.

Application of New Mental Health Parity Rules to Provider Network Composition and Reimbursement: Perspective and Analysis

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.
For more on Mental Health, visit the NLR Health Law Managed Care section

Minimizing National Labor Relations Act Liability for Employers with Non-Unionized Workforces

This post continues our consideration of comments submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA).

Under current law, if a plan provides any mental health or substance use disorder (MH/SUD) benefits in any classification of benefits, benefits for that condition or use disorder must be provided in every classification in which medical/surgical (M/S) benefits are provided. Classifications for this purpose include inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. The proposed regulations modify this standard by providing that a plan does not provide benefits for MH/SUD benefits in every classification in which M/S benefits are provided unless the plan provides meaningful benefits for treatment for the condition or disorder in each such classification “as determined in comparison to the benefits provided for medical/surgical conditions in the classification.”

The term “meaningful benefits” is nowhere defined. The regulators nevertheless “recognize that the proposal to require meaningful benefits [ ] is related to scope of services.” “Scope of services” for this purpose generally refers to the types of treatments and treatment settings that are covered by a group health plan or health insurance issuer. The preamble to the proposed regulation invites comments on how the meaningful benefits requirement “would interact with the approach related to scope of services adopted under the 2013 final regulations.” The preamble of the 2013 final regulations addressed an issue characterized as ‘‘scope of services’’ or ‘‘continuum of care’’ but otherwise failed to provide any substance. Two examples from the proposed regulations do, however, give us a sense of what the regulators have in mind.

  • A plan that generally covers treatment for autism spectrum disorder (ASD), a mental health condition, and covers outpatient, out-of-network developmental evaluations for ASD but excludes all other benefits for outpatient treatment for ASD, including applied behavior analysis (ABA) therapy, when provided on an out-of-network basis. (ABA therapy is one of the primary treatments for ASD in children.) The plan generally covers the full range of outpatient treatments and treatment settings for M/S conditions and procedures when provided on an out-of-network basis. The plan in this example violates the applicable parity standards.
  • In another example, a plan generally covers diagnosis and treatment for eating disorders, a mental health condition, but specifically excludes coverage for nutrition counseling to treat eating disorders, including in the outpatient, in-network classification. Nutrition counseling is one of the primary treatments for eating disorders. The plan generally provides benefits for the primary treatments for medical conditions and surgical procedures in the outpatient, in-network classification. The exclusion of coverage for nutrition counseling for eating disorders results in the plan failing to provide meaningful benefits for the treatment of eating disorders in the outpatient, in-network classification, as determined in comparison to the benefits provided for M/S conditions in the classification. Therefore, the plan violates the proposed rules.

Notably, the newly proposed meaningful benefits requirement is separate from, and in addition to, the newly prescribed nonquantitative treatment limitation (NQTL) testing standards. These latter standards include a “no more restrictive” requirement, a “design and application” requirement and an “outcomes data and network composition” requirement. A handful of comments nevertheless urge the regulators to add scope of services to its non-exhaustive list of NQTLs. As a result, a plan’s scope of services would be subject to comprehensive NQTL testing. Or, put another way, they would be fed back into the NQTL testing loop. Using the first of the examples above, this would require that ABA therapy to be first compared to the treatment limitations imposed on some M/S benefits in each classification. But what benefits, exactly? The problem is that a plan’s scope of services – what types of treatments a plan will pay for and in what settings – is a high-level plan design feature and not an NQTL.

While reasonable minds can and do differ on much of the substance of the proposed regulations, we doubt that anyone would claim that they streamline or simplify compliance. Compliance with these rules is already complicated and expensive; if the final rule looks anything like the proposed regulations, compliance will only get more complicated and more expensive. The proposed meaningful benefits requirement is intended to prevent plans, as a matter of plan design, from satisfying the parity rules by offering nominal or insubstantial MH/SUD benefits when compared to similar M/S benefits in each classification. Treating a plan’s scope of services as itself a separate NQTL does not advance this goal.

© 2024 McDermott Will & Emery
by: Alden J. Bianchi of McDermott Will & Emery 

For more news on Health Care Law, visit the NLR Health Law and Managed Care section.