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Complying With the ‘Relevant Data’ Requirement Under the Final 2024 Mental Health Parity and Addiction Equity Act: A Proposal for a Workable Alternative

The Mental Health Parity and Addiction Equity Act (MHPAEA) generally requires group health plans and health insurance issuers to ensure that financial requirements (such as copays and deductibles), quantitative treatment limitations (such as visit limits), and nonquantitative treatment limitations (such as prior authorization and concurrent review) applicable to mental health or substance use disorder (MH/SUD) benefits are generally no more restrictive than the requirements or limitations applied to medical/surgical (M/S) benefits. The Consolidated Appropriations Act, 2021 imposed further obligations in the case of nonquantitative treatment limitations (NQTLs), which are the subject of final regulations issued in September 2024. (We explained the final regulations here.)

Among many other things, the final regulations establish a two-part test that applies to NQTLs consisting of:

  • The design and application requirement. This test requires that the processes, strategies, evidentiary standards, or other factors used in designing and applying an NQTL to MH/SUD benefits in each classification must be comparable to and applied no more stringently than those used in designing and applying the limitation with respect to M/S benefits in that same classification. For this purpose, classifications include inpatient, in-network care; inpatient, out-of-network care; outpatient, in-network care; outpatient, out-of-network care; emergency care; and prescription drugs.
  • The relevant data evaluation requirement. This test requires the plan or issuer to collect and evaluate relevant data in a manner reasonably designed to assess the impact of the NQTL on relevant outcomes related to access to MH/SUD benefits as compared to M/S benefits. Relevant data for this purpose includes the number and percentage of relevant claims denials and network composition data.

The relevant data evaluation requirement has proven especially challenging for self-funded group health plans of every size, as third-party administrators fail, refuse, or are otherwise unable to provide the information necessary to comply. There may be another option, however.

The final regulations do not specify the data set on which compliance with the relevant data requirement is tested. Rather, the regulations, which apply to both plans and issuers, seem to assume that the plans test on the basis of plan data, and issuers test on the basis of the issuer’s corresponding block of business. In their informal remarks at trade and industry conferences, representatives of the US Department of Labor (DOL), expressing their own views and not those of the DOL, have acknowledged that they are aware of and are considering their options related to the proper testing data set.

Some large carriers have shared the NQTL analysis that they previously prepared for their fully insured groups with the self-funded group to whom they provide administrative services. Presumably, this will give their self-funded groups a starting point. Many self-funded groups, particularly smaller groups, are not inclined to modify the standard set of NQTLs offered by their carriers/administrative-service-only (ASO) providers. If these groups were allowed to test based on the carrier’s corresponding book of business, a good deal of the work would be done. This would also have the salutary effect of exerting market pressure [...]

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The ‘Data Evaluation Requirement’ for NQTLs Under the Newly Proposed MHPAEA Regulations

Last week’s post examined the “no more restrictive” requirement that would apply to non-quantitative treatment limitations (NQTLs) set out in recently proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). (Our description of the proposed regulations is available here.) The proposed regulations deal principally with NQTLs, which are non-numeric benefit coverage limits that must be no more restrictive for mental health and substance use disorder (MH/SUD) benefits than for medical surgical (M/S) benefits. We previously claimed that “if adopted in final form [the proposed regulations] would vastly complicate compliance by group health plans and health insurance issuers with an already challenging set of mental health parity rules.” Our views have not changed.

The proposed regulations would, if adopted, impose a series of new requirements on NQTLs that include a “data evaluation requirement.” This new requirement would provide that the plan or issuer designing and applying an NQTL collect and evaluate relevant data to assess the impact of the NQTL on access to MH/SUD and M/S benefits. The plan or issuer would also consider whether the NQTL, in operation, complies with the mental health parity rules. The specific type, form, and manner of data collection and evaluation will be the subject of future guidance. (A technical release accompanied the proposed regulations, described here, which invites comment and suggests a possible, narrow safe harbor.)

The proposed regulations establish two new network-related rules governing NQTLs:

  • For NQTLs not involving network composition, a material difference in the metrics/data gathering for the NQTL as applied to MH/SUD and M/S benefits would be considered a strong indicator of a violation.
  • For NQTLs involving network composition, a violation is deemed to occur if the relevant data shows material differences in access to in-network MH/SUD benefits as compared to in-network M/S benefits.

The proposed regulations would make compliance depend on outcomes. This position represents a significant shift in, if not an outright reversal of, existing law. Under the 2013 final MHPAEA regulations, outcomes are not determinative of compliance. Rather, comparability turns on the application of processes, strategies, evidentiary standards and other design-based factors. Compliance under current law thus turns on an examination of inputs, not outcomes. While the proposed regulations include exceptions for professional medical/clinical standards and for standards to detect fraud, waste and abuse, the preamble to the proposed regulations advises that “these exceptions should be narrowly tailored.”




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Welcome (But Last Minute) Relief for Prescription Drug Reporting Originally Due December 27

Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules governing prescription drug data collection (RxDC). The rules require group health plans, including plans offered to Federal Employees Health Benefits carriers, and health insurance issuers to report certain information related to prescription drug and other healthcare expenditures to the US Departments of Labor, Health and Human Services and the Treasury (collectively, the Departments). Under the statute, the first RxDC reports were due to be filed by December 27, 2021. However, in response to concerns expressed by stakeholders, enforcement was pushed back a full year to December 27, 2022.

In an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56), the Departments provided relief to group health plans and health insurance issuers who are required to report information relating to prescription drug and healthcare spending.

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