26 CFR Part 54

Excise taxes, Pensions, Reporting and recordkeeping requirements.

29 CFR Part 2590

Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.

45 CFR Part 146

Health care, Health insurance, Reporting and recordkeeping requirements.

45 CFR Part 147

Aged, Citizenship and naturalization, Civil rights, Health care, Health insurance, Individuals with disabilities, Intergovernmental relations, Reporting and recordkeeping requirements, Sex discrimination.

Douglas W. O’Donnell,

Deputy Commissioner for Services and Enforcement,

Internal Revenue Service.

Lisa M. Gomez,

Assistant Secretary, Employee Benefits Security Administration, Department of Labor.

Xavier Becerra,

Secretary,

Department of Health and Human Services.

Accordingly, the Treasury Department and the IRS propose to amend 26 CFR part 54 as follows:

1. The authority citation for part 54 continues to read in part as follows:

Authority: 26 U.S.C. 7805 * * *

2. Amend § 54.9812-1 by:

a. Redesignating paragraph (a) as paragraph (a)(2) and adding paragraphs (a) heading and (a)(1);

b. In newly redesignated paragraph (a)(2):

i. Revising the introductory text;

ii. Adding the definitions of “DSM,” “Evidentiary standards,” “Factors,” and “ICD” in alphabetical order;

iii. Revising the definitions of “Medical/surgical benefits” and “Mental health benefits”;

iv. Adding the definitions of “Processes” and “Strategies” in alphabetical order; and

v. Revising the definitions of “Substance use disorder benefits” and “Treatment limitations”;

c. Revising paragraphs (c)(1)(ii), (c)(2)(i), and (c)(2)(ii)(A) introductory text;

d. In paragraph (c)(2)(ii)(C), designating Examples 1 through 4 as paragraphs (c)(2)(ii)(C)(1) through (4) and revising newly designated paragraphs (c)(2)(ii)(C)(1) through (4);

e. Adding paragraphs (c)(2)(ii)(C)(5) and (6);

f. Revising paragraphs (c)(3)(i)(A), (C), and (D);

g. In paragraph (c)(3)(iii), adding introductory text;

h. Revising paragraphs (c)(3)(iii)(A) and (B), (c)(3)(iv), (c)(4), (d)(3), (e)(4), and (i)(1); and

i. Adding paragraph (j).

The revisions and additions read as follows:

(a) Purpose and meaning of terms—(1) Purpose. This section and § 54.9812-2 set forth rules to ensure parity in aggregate lifetime and annual dollar limits, financial requirements, and quantitative and nonquantitative treatment limitations between mental health and substance use disorder benefits and medical/surgical benefits, as required under Code section 9812. A fundamental purpose of Code section 9812, this section, and § 54.9812-2 is to ensure that participants and beneficiaries in a group health plan that offers mental health or substance use disorder benefits are not subject to more restrictive lifetime or annual dollar limits, financial requirements, or treatment limitations with respect to those benefits than the predominant dollar limits, financial requirements, or treatment limitations that are applied to substantially all medical/surgical benefits covered by the plan, as further provided in this section and § 54.9812-2. Accordingly, in complying with the provisions of Code section 9812, this section, and § 54.9812-2, plans must not design or apply financial requirements and treatment limitations that impose a greater burden on access (that is, are more restrictive) to mental health and substance use disorder benefits under the plan than they impose on access to generally comparable medical/surgical benefits. The provisions of Code section 9812, this section, and § 54.9812-2 should be interpreted in a manner that is consistent with the purpose described in this paragraph (a)(1).

(2) Meaning of terms. For purposes of this section and § 54.9812-2, except where the context clearly indicates otherwise, the following terms have the meanings indicated:

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DSM means the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders. For the purpose of this definition, the most current version of the DSM is the version that is applicable no earlier than on the date that is 1 year before the first day of the applicable plan year.

Evidentiary standards are any evidence, sources, or standards that a group health plan considered or relied upon in designing or applying a factor with respect to a nonquantitative treatment limitation, including specific benchmarks or thresholds. Evidentiary standards may be empirical, statistical, or clinical in nature, and include: sources acquired or originating from an objective third party, such as recognized medical literature, professional standards and protocols (which may include comparative effectiveness studies and clinical trials), published research studies, payment rates for items and services (such as publicly available databases of the “usual, customary and reasonable” rates paid for items and services), and clinical treatment guidelines; internal plan data, such as claims or utilization data or criteria for assuring a sufficient mix and number of network providers; and benchmarks or thresholds, such as measures of excessive utilization, cost levels, time or distance standards, or network participation percentage thresholds.

Factors are all information, including processes and strategies (but not evidentiary standards), that a group health plan considered or relied upon to design a nonquantitative treatment limitation, or to determine whether or how the nonquantitative treatment limitation applies to benefits under the plan. Examples of factors include, but are not limited to: provider discretion in determining a diagnosis or type or length of treatment; clinical efficacy of any proposed treatment or service; licensing and accreditation of providers; claim types with a high percentage of fraud; quality measures; treatment outcomes; severity or chronicity of condition; variability in the cost of an episode of treatment; high cost growth; variability in cost and quality; elasticity of demand; and geographic location.

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ICD means the World Health Organization’s International Classification of Diseases adopted by the Department of Health and Human Services through 45 CFR 162.1002. For the purpose of this definition, the most current version of the ICD is the version that is applicable no earlier than on the date that is 1 year before the first day of the applicable plan year.

Medical/surgical benefits means benefits with respect to items or services for medical conditions or surgical procedures, as defined under the terms of the group health plan and in accordance with applicable Federal and State law, but does not include mental health benefits or substance use disorder benefits. Notwithstanding the preceding sentence, any condition or procedure defined by the plan as being or as not being a medical condition or surgical procedure must be defined consistent with generally recognized independent standards of current medical practice (for example, the most current version of the ICD). To the extent generally recognized independent standards of current medical practice do not address whether a condition or procedure is a medical condition or surgical procedure, plans may define the condition or procedure in accordance with applicable Federal and State law.

Mental health benefits means benefits with respect to items or services for mental health conditions, as defined under the terms of the group health plan and in accordance with applicable Federal and State law, but does not include medical/surgical benefits or substance use disorder benefits. Notwithstanding the preceding sentence, any condition defined by the plan as being or as not being a mental health condition must be defined consistent with generally recognized independent standards of current medical practice. For the purpose of this definition, to be consistent with generally recognized independent standards of current medical practice, the definition must include all conditions covered under the plan, except for substance use disorders, that fall under any of the diagnostic categories listed in the mental, behavioral, and neurodevelopmental disorders chapter (or equivalent chapter) of the most current version of the ICD or that are listed in the most current version of the DSM. To the extent generally recognized independent standards of current medical practice do not address whether a condition is a mental health condition, plans may define the condition in accordance with applicable Federal and State law.

Processes are actions, steps, or procedures that a group health plan uses to apply a nonquantitative treatment limitation, including actions, steps, or procedures established by the plan as requirements in order for a participant or beneficiary to access benefits, including through actions by a participant’s or beneficiary’s authorized representative or a provider or facility. Processes include but are not limited to: procedures to submit information to authorize coverage for an item or service prior to receiving the benefit or while treatment is ongoing (including requirements for peer or expert clinical review of that information); provider referral requirements; and the development and approval of a treatment plan. Processes also include the specific procedures used by staff or other representatives of a plan (or the service provider of a plan) to administer the application of nonquantitative treatment limitations, such as how a panel of staff members applies the nonquantitative treatment limitation (including the qualifications of staff involved, number of staff members allocated, and time allocated), consultations with panels of experts in applying the nonquantitative treatment limitation, and reviewer discretion in adhering to criteria hierarchy when applying a nonquantitative treatment limitation.

Strategies are practices, methods, or internal metrics that a plan considers, reviews, or uses to design a nonquantitative treatment limitation. Examples of strategies include but are not limited to: the development of the clinical rationale used in approving or denying benefits; deviation from generally accepted standards of care; the selection of information deemed reasonably necessary to make a medical necessity determination; reliance on treatment guidelines or guidelines provided by third-party organizations; and rationales used in selecting and adopting certain threshold amounts, professional protocols, and fee schedules. Strategies also include the creation and composition of the staff or other representatives of a plan (or the service provider of a plan) that deliberates, or otherwise makes decisions, on the design of nonquantitative treatment limitations, including the plan’s decisions related to the qualifications of staff involved, number of staff members allocated, and time allocated; breadth of sources and evidence considered; consultations with panels of experts in designing the nonquantitative treatment limitation; and the composition of the panels used to design a nonquantitative treatment limitation.

Substance use disorder benefits means benefits with respect to items or services for substance use disorders, as defined under the terms of the group health plan and in accordance with applicable Federal and State law, but does not include medical/surgical benefits or mental health benefits. Notwithstanding the preceding sentence, any disorder defined by the plan as being or as not being a substance use disorder must be defined consistent with generally recognized independent standards of current medical practice. For the purpose of this definition, to be consistent with generally recognized independent standards of current medical practice, the definition must include all disorders covered under the plan that fall under any of the diagnostic categories listed as a mental or behavioral disorder due to psychoactive substance use (or equivalent category) in the mental, behavioral and neurodevelopmental disorders chapter (or equivalent chapter) of the most current version of the ICD or that are listed as a Substance-Related and Addictive Disorder (or equivalent category) in the most current version of the DSM. To the extent generally recognized independent standards of current medical practice do not address whether a disorder is a substance use disorder, plans may define the disorder in accordance with applicable Federal and State law.

Treatment limitations include limits on benefits based on the frequency of treatment, number of visits, days of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. Treatment limitations include both quantitative treatment limitations, which are expressed numerically (such as 50 outpatient visits per year), and nonquantitative treatment limitations, which otherwise limit the scope or duration of benefits for treatment under a plan. (See paragraph (c)(4)(iii) of this section for an illustrative, non-exhaustive list of nonquantitative treatment limitations.) A complete exclusion of all benefits for a particular condition or disorder, however, is not a treatment limitation for purposes of this definition.

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(c) * * *

(1) * * *

(ii) Type of financial requirement or treatment limitation. When reference is made in this paragraph (c) to a type of financial requirement or treatment limitation, the reference to type means its nature. Different types of financial requirements include deductibles, copayments, coinsurance, and out-of-pocket maximums. Different types of quantitative treatment limitations include annual, episode, and lifetime day and visit limits. See paragraph (c)(4)(iii) of this section for an illustrative, non-exhaustive list of nonquantitative treatment limitations.

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(2) * * *

(i) General rule. A group health plan that provides both medical/surgical benefits and mental health or substance use disorder benefits may not apply any financial requirement or treatment limitation to mental health or substance use disorder benefits in any classification that is more restrictive than the predominant financial requirement or treatment limitation of that type applied to substantially all medical/surgical benefits in the same classification. Whether a financial requirement or treatment limitation is a predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in a classification is determined separately for each type of financial requirement or treatment limitation. A plan may not impose any financial requirement or treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and not to any medical/surgical benefits in the same benefit classification. The application of the rules of this paragraph (c)(2) to financial requirements and quantitative treatment limitations is addressed in paragraph (c)(3) of this section; the application of the rules of this paragraph (c)(2) to nonquantitative treatment limitations is addressed in paragraph (c)(4) of this section.

(ii) * * *

(A) In general. If a plan provides any benefits for a mental health condition or substance use disorder in any classification of benefits described in this paragraph (c)(2)(ii), benefits for that mental health condition or substance use disorder must be provided in every classification in which medical/surgical benefits are provided. For purposes of this paragraph (c)(2)(ii), a plan providing any benefits for a mental health condition or substance use disorder in any classification of benefits does not provide benefits for the mental health condition or substance use disorder in every classification in which medical/surgical benefits are provided unless the plan provides meaningful benefits for treatment for that condition or disorder in each such classification, as determined in comparison to the benefits provided for medical/surgical conditions in the classification. In determining the classification in which a particular benefit belongs, a plan must apply the same standards to medical/surgical benefits and to mental health or substance use disorder benefits. To the extent that a plan provides benefits in a classification and imposes any separate financial requirement or treatment limitation (or separate level of a financial requirement or treatment limitation) for benefits in the classification, the rules of this paragraph (c) apply separately with respect to that classification for all financial requirements or treatment limitations (illustrated in examples in paragraph (c)(2)(ii)(C) of this section). The following classifications of benefits are the only classifications used in applying the rules of this paragraph (c), in addition to the permissible sub-classifications described in paragraph (c)(3)(iii) of this section:

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(C) * * *

(1) Example 1—(i) Facts. A group health plan offers inpatient and outpatient benefits and does not contract with a network of providers. The plan imposes a $500 deductible on all benefits. For inpatient medical/surgical benefits, the plan imposes a coinsurance requirement. For outpatient medical/surgical benefits, the plan imposes copayments. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(1) (Example 1), because the plan has no network of providers, all benefits provided are out-of-network. Because inpatient, out-of-network medical/surgical benefits are subject to separate financial requirements from outpatient, out-of-network medical/surgical benefits, the rules of this paragraph (c) apply separately with respect to any financial requirements and treatment limitations, including the deductible, in each classification.

(2) Example 2—(i) Facts. A plan imposes a $500 deductible on all benefits. The plan has no network of providers. The plan generally imposes a 20 percent coinsurance requirement with respect to all benefits, without distinguishing among inpatient, outpatient, emergency care, or prescription drug benefits. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(2) (Example 2), because the plan does not impose separate financial requirements (or treatment limitations) based on classification, the rules of this paragraph (c) apply with respect to the deductible and the coinsurance across all benefits.

(3) Example 3—(i) Facts. Same facts as in paragraph (c)(2)(ii)(C)(2)(i) of this section (Example 2), except the plan exempts emergency care benefits from the 20 percent coinsurance requirement. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(3) (Example 3), because the plan imposes separate financial requirements based on classifications, the rules of this paragraph (c) apply with respect to the deductible and the coinsurance separately for benefits in the emergency care classification and all other benefits.

(4) Example 4—(i) Facts. Same facts as in paragraph (c)(2)(ii)(C)(2)(i) of this section (Example 2), except the plan also imposes a preauthorization requirement for all inpatient treatment in order for benefits to be paid. No such requirement applies to outpatient treatment.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(4) (Example 4), because the plan has no network of providers, all benefits provided are out-of-network. Because the plan imposes a separate treatment limitation based on classifications, the rules of this paragraph (c) apply with respect to the deductible and coinsurance separately for inpatient, out-of-network benefits and all other benefits.

(5) Example 5—(i) Facts. A plan 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 behavioral analysis (ABA) therapy, when provided on an out-of-network basis. The plan generally covers the full range of outpatient treatments and treatment settings for medical conditions and surgical procedures when provided on an out-of-network basis.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(5) (Example 5), the plan violates the rules of this paragraph (c)(2)(ii). Because the plan only covers one type of benefit for ASD in the outpatient, out-of-network classification and excludes all other benefits for ASD in the classification, but generally covers the full range of medical/surgical benefits in the classification, it fails to provide meaningful benefits for treatment of ASD in the classification.

(6) Example 6—(i) Facts. 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/surgical conditions in the outpatient, in-network classification.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(6) (Example 6), the plan violates the rules of this paragraph (c)(2)(ii). 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 medical/surgical conditions in the classification.

(3) * * *

(i) * * *

(A) Substantially all. For purposes of this paragraph (c)(3), a type of financial requirement or quantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification of benefits if it applies to at least two-thirds of all medical/surgical benefits in that classification. (For purposes of this paragraph (c)(3)(i)(A), benefits expressed as subject to a zero level of a type of financial requirement are treated as benefits not subject to that type of financial requirement, and benefits expressed as subject to a quantitative treatment limitation that is unlimited are treated as benefits not subject to that type of quantitative treatment limitation.) If a type of financial requirement or quantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, then that type cannot be applied to mental health or substance use disorder benefits in that classification.

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(C) Portion based on plan payments. For purposes of this paragraph (c)(3), the determination of the portion of medical/surgical benefits in a classification of benefits subject to a financial requirement or quantitative treatment limitation (or subject to any level of a financial requirement or quantitative treatment limitation) is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan for the plan year (or for the portion of the plan year after a change in plan benefits that affects the applicability of the financial requirement or quantitative treatment limitation).

(D) Clarifications for certain threshold requirements. For any deductible, the dollar amount of plan payments includes all plan payments with respect to claims that would be subject to the deductible if it had not been satisfied. For any out-of-pocket maximum, the dollar amount of plan payments includes all plan payments associated with out-of-pocket payments that are taken into account towards the out-of-pocket maximum as well as all plan payments associated with out-of-pocket payments that would have been made towards the out-of-pocket maximum if it had not been satisfied. Similar rules apply for any other thresholds at which the rate of plan payment changes. (See also PHS Act section 2707 and Affordable Care Act section 1302(c), which establish annual limitations on out-of-pocket maximums for all non-grandfathered health plans.)

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(iii) Special rules. Unless specifically permitted under this paragraph (c)(3)(iii), sub-classifications are not permitted when applying the rules of paragraph (c)(3) of this section.

(A) Multi-tiered prescription drug benefits. If a plan applies different levels of financial requirements to different tiers of prescription drug benefits based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section (relating to requirements for nonquantitative treatment limitations) and without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits, the plan satisfies the parity requirements of this paragraph (c) with respect to prescription drug benefits. Reasonable factors include cost, efficacy, generic versus brand name, and mail order versus pharmacy pick-up.

(B) Multiple network tiers. If a plan provides benefits through multiple tiers of in-network providers (such as an in-network tier of preferred providers with more generous cost-sharing to participants than a separate in-network tier of participating providers), the plan may divide its benefits furnished on an in-network basis into sub-classifications that reflect network tiers, if the tiering is based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section (such as quality, performance, and market standards) and without regard to whether a provider provides services with respect to medical/surgical benefits or mental health or substance use disorder benefits. After the sub-classifications are established, the plan may not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in any sub-classification that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in the sub-classification using the methodology set forth in paragraph (c)(3)(i) of this section.

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(iv) Examples. The rules of paragraphs (c)(3)(i) through (iii) of this section are illustrated by the following examples. In each example, the group health plan is subject to the requirements of this section and provides both medical/surgical benefits and mental health and substance use disorder benefits.

(A) Example 1—(1) Facts. (i) For inpatient, out-of-network medical/surgical benefits, a group health plan imposes five levels of coinsurance. Using a reasonable method, the plan projects its payments for the upcoming year as follows:

 

(ii) The plan projects plan costs of $800x to be subject to coinsurance ($100x + $450x + $100x + $150x = $800x). Thus, 80 percent ($800x/$1,000x) of the benefits are projected to be subject to coinsurance, and 56.25 percent of the benefits subject to coinsurance are projected to be subject to the 15 percent coinsurance level.

(2) Conclusion. In this paragraph (c)(3)(iv)(A) (Example 1), the two-thirds threshold of the substantially all standard is met for coinsurance because 80 percent of all inpatient, out-of-network medical/surgical benefits are subject to coinsurance. Moreover, the 15 percent coinsurance is the predominant level because it is applicable to more than one-half of inpatient, out-of-network medical/surgical benefits subject to the coinsurance requirement. The plan may not impose any level of coinsurance with respect to inpatient, out-of-network mental health or substance use disorder benefits that is more restrictive than the 15 percent level of coinsurance.

(B) Example 2—(1) Facts. (i) For outpatient, in-network medical/surgical benefits, a plan imposes five different copayment levels. Using a reasonable method, the plan projects payments for the upcoming year as follows:

 

(ii) The plan projects plan costs of $800x to be subject to copayments ($200x + $200x +$300x + $100x = $800x). Thus, 80 percent ($800x/$1,000x) of the benefits are projected to be subject to a copayment.

(2) Conclusion. In this paragraph (c)(3)(iv)(B) (Example 2), the two-thirds threshold of the substantially all standard is met for copayments because 80 percent of all outpatient, in-network medical/surgical benefits are subject to a copayment. Moreover, there is no single level that applies to more than one-half of medical/surgical benefits in the classification subject to a copayment (for the $10 copayment, 25%; for the $15 copayment, 25%; for the $20 copayment, 37.5%; and for the $50 copayment, 12.5%). The plan can combine any levels of copayment, including the highest levels, to determine the predominant level that can be applied to mental health or substance use disorder benefits. If the plan combines the highest levels of copayment, the combined projected payments for the two highest copayment levels, the $50 copayment and the $20 copayment, are not more than one-half of the outpatient, in-network medical/surgical benefits subject to a copayment because they are exactly one-half ($300x + $100x = $400x; $400x/$800x = 50%). The combined projected payments for the three highest copayment levels – the $50 copayment, the $20 copayment, and the $15 copayment – are more than one-half of the outpatient, in-network medical/surgical benefits subject to the copayments ($100x + $300x + $200x = $600x; $600x/$800x = 75%). Thus, the plan may not impose any copayment on outpatient, in-network mental health or substance use disorder benefits that is more restrictive than the least restrictive copayment in the combination, the $15 copayment.

(C) Example 3—(1) Facts. A plan imposes a $250 deductible on all medical/surgical benefits for self-only coverage and a $500 deductible on all medical/surgical benefits for family coverage. The plan has no network of providers. For all medical/surgical benefits, the plan imposes a coinsurance requirement. The plan imposes no other financial requirements or treatment limitations.

(2) Conclusion. In this paragraph (c)(3)(iv)(C) (Example 3), because the plan has no network of providers, all benefits are provided out-of-network. Because self-only and family coverage are subject to different deductibles, whether the deductible applies to substantially all medical/surgical benefits is determined separately for self-only medical/surgical benefits and family medical/surgical benefits. Because the coinsurance is applied without regard to coverage units, the predominant coinsurance that applies to substantially all medical/surgical benefits is determined without regard to coverage units.

(D) Example 4—(1) Facts. A plan applies the following financial requirements for prescription drug benefits. The requirements are applied without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits. Moreover, the process for certifying a particular drug as “generic”, “preferred brand name”, “non-preferred brand name”, or “specialty” complies with the rules of paragraph (c)(4) of this section (relating to requirements for nonquantitative treatment limitations).

Table 3 to Paragraph (c)(3)(iv)(D)(1)

 

(2) Conclusion. In this paragraph (c)(3)(iv)(D) (Example 4), the financial requirements that apply to prescription drug benefits are applied without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits; the process for certifying drugs in different tiers complies with paragraph (c)(4) of this section; and the bases for establishing different levels or types of financial requirements are reasonable. The financial requirements applied to prescription drug benefits do not violate the parity requirements of this paragraph (c)(3).

(E) Example 5—(1) Facts. A plan has two-tiers of network of providers: a preferred provider tier and a participating provider tier. Providers are placed in either the preferred tier or participating tier based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section, such as accreditation, quality and performance measures (including customer feedback), and relative reimbursement rates. Furthermore, provider tier placement is determined without regard to whether a provider specializes in the treatment of mental health conditions or substance use disorders, or medical/surgical conditions. The plan divides the in-network classifications into two sub-classifications (in-network/preferred and in-network/participating). The plan does not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in either of these sub-classifications that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in each sub-classification.

(2) Conclusion. In this paragraph (c)(3)(iv)(E) (Example 5), the division of in-network benefits into sub-classifications that reflect the preferred and participating provider tiers does not violate the parity requirements of this paragraph (c)(3).

(F) Example 6—(1) Facts. With respect to outpatient, in-network benefits, a plan imposes a $25 copayment for office visits and a 20 percent coinsurance requirement for outpatient surgery. The plan divides the outpatient, in-network classification into two sub-classifications (in-network office visits and all other outpatient, in-network items and services). The plan does not impose any financial requirement or quantitative treatment limitation on mental health or substance use disorder benefits in either of these sub-classifications that is more restrictive than the predominant financial requirement or quantitative treatment limitation that applies to substantially all medical/surgical benefits in each sub-classification.

(2) Conclusion. In this paragraph (c)(3)(iv)(F) (Example 6), the division of outpatient, in-network benefits into sub-classifications for office visits and all other outpatient, in-network items and services does not violate the parity requirements of this paragraph (c)(3).

(G) Example 7—(1) Facts. Same facts as in paragraph (c)(3)(iv)(F)(1) of this section (Example 6), but for purposes of determining parity, the plan divides the outpatient, in-network classification into outpatient, in-network generalists and outpatient, in-network specialists.

(2) Conclusion. In this paragraph (c)(3)(iv)(G) (Example 7), the division of outpatient, in-network benefits into any sub-classifications other than office visits and all other outpatient items and services violates the requirements of paragraph (c)(3)(iii)(C) of this section.

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(4) Nonquantitative treatment limitations. Subject to paragraph (c)(4)(v) of this section, a group health plan may not impose a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in a classification unless the plan’s imposition of the limitation meets the requirements of paragraphs (c)(4)(i), (ii), and (iv) of this section. If a group health plan fails to meet any of these requirements with respect to a nonquantitative treatment limitation, the limitation violates Code section 9812(a)(3)(A)(ii) and may not be imposed by the plan.

(i) Requirement that nonquantitative treatment limitations be no more restrictive for mental health benefits and substance use disorder benefits. A group health plan may not apply any nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification that is more restrictive, as written or in operation, than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the same classification.

(A) Restrictive. For purposes of this paragraph (c)(4)(i), a nonquantitative treatment limitation is restrictive to the extent it imposes conditions, terms, or requirements that limit access to benefits under the terms of the plan. Conditions, terms, or requirements include, but are not limited to, those that compel an action by or on behalf of a participant or beneficiary to access benefits or limit access to the full range of treatment options available for a condition or disorder under the plan.

(B) Substantially all. For purposes of this paragraph (c)(4)(i), a nonquantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification if it applies to at least two-thirds of all medical/surgical benefits in that classification, consistent with paragraph (c)(4)(i)(D) of this section. Whether the nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits is determined without regard to whether the nonquantitative treatment limitation was triggered based on a particular factor or evidentiary standard. If a nonquantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, then that limitation cannot be applied to mental health or substance use disorder benefits in that classification.

(C) Predominant. For purposes of this paragraph (c)(4)(i), the term predominant means the most common or most frequent variation of the nonquantitative treatment limitation within a classification, determined in accordance with the method outlined in paragraph (c)(4)(i)(D) of this section, to the extent the plan imposes multiple variations of a nonquantitative treatment limitation within the classification. For example, multiple variations of inpatient concurrent review include review commencing 1 day, 3 days, or 7 days after admission, depending on the reason for the stay.

(D) Portion based on plan payments. For purposes of paragraphs (c)(4)(i)(B) and (C) of this section, the determination of the portion of medical/surgical benefits in a classification of benefits subject to a nonquantitative treatment limitation is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan for the plan year (or the portion of the plan year after a change in benefits that affects the applicability of the nonquantitative treatment limitation). Any reasonable method may be used to determine the dollar amount expected to be paid under a plan for medical/surgical benefits.

(E) Exceptions for independent professional medical or clinical standards and standards to detect or prevent and prove fraud, waste, and abuse. Notwithstanding paragraphs (c)(4)(i)(A) through (D) of this section, a plan that applies a nonquantitative treatment limitation that impartially applies independent professional medical or clinical standards or applies standards to detect or prevent and prove fraud, waste, and abuse, as described in paragraph (c)(4)(v)(A) or (B) of this section, to mental health or substance use disorder benefits in any classification will not be considered to violate this paragraph (c)(4)(i) with respect to such nonquantitative treatment limitation.

(ii) Additional requirements related to design and application of the nonquantitative treatment limitation—(A) In general. Consistent with paragraph (a)(1) of this section, a plan may not impose a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification unless, under the terms of the plan as written and in operation, any processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the classification 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 in the classification.

(B) Prohibition on discriminatory factors and evidentiary standards. For purposes of determining comparability and stringency under paragraph (c)(4)(ii)(A) of this section, a plan may not rely upon any factor or evidentiary standard if the information, evidence, sources, or standards on which the factor or evidentiary standard is based discriminates against mental health or substance use disorder benefits as compared to medical/surgical benefits. For purposes of this paragraph (c)(4)(ii)(B):

(1) Impartially applied generally recognized independent professional medical or clinical standards described in paragraph (c)(4)(v)(A) of this section are not considered to discriminate against mental health or substance use disorder benefits.

(2) Standards reasonably designed to detect or prevent and prove fraud, waste, and abuse described in paragraph (c)(4)(v)(B) of this section are not considered to discriminate against mental health or substance use disorder benefits.

(3) Information is considered to discriminate against mental health or substance use disorder benefits if it is biased or not objective, in a manner that results in less favorable treatment of mental health or substance use disorder benefits, based on all the relevant facts and circumstances including, but not limited to, the source of the information, the purpose or context of the information, and the content of the information.

(iii) Illustrative, non-exhaustive list of nonquantitative treatment limitations. Nonquantitative treatment limitations include –

(A) Medical management standards (such as prior authorization) limiting or excluding benefits based on medical necessity or medical appropriateness, or based on whether the treatment is experimental or investigative;

(B) Formulary design for prescription drugs;

(C) For plans with multiple network tiers (such as preferred providers and participating providers), network tier design;

(D) Standards related to network composition, including but 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;

(E) Plan 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;

(F) Refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is not effective (also known as fail-first policies or step therapy protocols);

(G) Exclusions based on failure to complete a course of treatment; and

(H) Restrictions based on geographic location, facility type, provider specialty, and other criteria that limit the scope or duration of benefits for services provided under the plan.

(iv) Required use of outcomes data—(A) In general. When designing and applying a nonquantitative treatment limitation, a plan must collect and evaluate relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation on access to mental health and substance use disorder benefits and medical/surgical benefits, and consider the impact as part of the plan’s analysis of whether the limitation, in operation, complies with paragraphs (c)(4)(i) and (ii) of this section. The Secretary, jointly with the Secretary of the Department of Labor and the Secretary of Health and Human Services, may specify in guidance the type, form, and manner of collection and evaluation for the data required under this paragraph (c)(4)(iv)(A).

(1) For purposes of this paragraph (c)(4)(iv)(A), relevant data includes, but is not limited to, the number and percentage of claims denials and any other data relevant to the nonquantitative treatment limitation required by State law or private accreditation standards.

(2) In addition to the relevant data set forth in paragraph (c)(4)(iv)(A)(1) of this section, relevant data for nonquantitative treatment limitations related to network composition standards includes, but is 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, and data on providers accepting new patients), and provider reimbursement rates (including as compared to billed charges).

(B) Material differences. Subject to paragraph (c)(4)(iv)(C) of this section, to the extent the relevant data evaluated pursuant to paragraph (c)(4)(iv)(A) of this section show material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, the differences will be considered a strong indicator that the plan violates paragraph (c)(4)(i) or (ii) of this section. In such instances, the plan:

(1) Must take reasonable action to address the material differences in access as necessary to ensure compliance, in operation, with paragraphs (c)(4)(i) and (ii) of this section; and

(2) Must document the action that has been or is being taken by the plan to mitigate any material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, as required by § 54.9812-2(c)(5)(iv).

(C) Special rule for nonquantitative treatment limitations related to network composition. Notwithstanding paragraph (c)(4)(iv)(B) of this section, when designing and applying one or more nonquantitative treatment limitation(s) related to network composition standards, a plan fails to meet the requirements of paragraphs (c)(4)(i) and (ii) of this section, in operation, if the relevant data show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in a classification.

(D) Exception for independent professional medical or clinical standards. A plan designing and applying a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification that impartially applies independent professional medical or clinical standards, as described in paragraph (c)(4)(v)(A) of this section, is not required to comply with the requirements of this paragraph (c)(4)(iv) with respect to that classification.

(v) Independent professional medical or clinical standards and standards to detect or prevent and prove fraud, waste, and abuse. (A) To qualify for the exceptions in paragraphs (c)(4)(i)(E), (c)(4)(ii)(B), and (c)(4)(iv)(D) of this section for independent professional medical or clinical standards, a nonquantitative treatment limitation must impartially apply generally recognized independent professional medical or clinical standards (consistent with generally accepted standards of care) to medical/surgical benefits and mental health or substance use disorder benefits, and may not deviate from those standards in any way, such as by imposing additional or different requirements.

(B) To qualify for the exceptions in paragraphs (c)(4)(i)(E) and (c)(4)(ii)(B) of this section to detect or prevent and prove fraud, waste, and abuse, a nonquantitative treatment limitation must be reasonably designed to detect or prevent and prove fraud, waste, and abuse, based on indicia of fraud, waste, and abuse that have been reliably established through objective and unbiased data, and also be narrowly designed to minimize the negative impact on access to appropriate mental health and substance use disorder benefits.

(vi) Prohibition on separate nonquantitative treatment limitations applicable only to mental health or substance use disorder benefits. Consistent with paragraph (c)(2)(i) of this section, a group health plan may not apply any nonquantitative treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and does not apply with respect to any medical/surgical benefits in the same benefit classification.

(vii) Effect of final determination of noncompliance under § 54.9812-2. If a group health plan receives a final determination from the Secretary that the plan is not in compliance with the requirements of § 54.9812-2 with respect to a nonquantitative treatment limitation, the nonquantitative treatment limitation violates this paragraph (c)(4) and the Secretary may direct the plan not to impose the nonquantitative treatment limitation, unless and until the plan demonstrates to the Secretary compliance with the requirements of this section or takes appropriate action to remedy the violation.

(viii) Examples. The rules of this paragraph (c)(4) are illustrated by the following examples. In each example, the group health plan is subject to the requirements of this section and provides both medical/surgical benefits and mental health and substance use disorder benefits. Additionally, in examples that conclude that the plan violates one provision of this paragraph (c)(4), such examples do not necessarily imply compliance with other provisions of this paragraph (c)(4), as these examples do not analyze compliance with all other provisions of this paragraph (c)(4).

(A) Example 1 (More restrictive prior authorization requirement in operation)—(1) Facts. A plan requires prior authorization from the plan’s utilization reviewer that a treatment is medically necessary for all inpatient, in-network medical/surgical benefits and for all inpatient, in-network mental health and substance use disorder benefits. While inpatient, in-network benefits for medical/surgical conditions are approved for periods of 1, 3, and 7 days, after which a treatment plan must be submitted by the patient’s attending provider and approved by the plan, the approvals for 7 days are most common under this plan. For inpatient, in-network mental health and substance use disorder benefits, routine approval is most commonly given only for one day, after which a treatment plan must be submitted by the patient’s attending provider and approved by the plan. The difference in the duration of approvals is not the result of independent professional medical or clinical standards or standards to detect or prevent and prove fraud, waste, and abuse, but rather reflects the application of a heightened standard to the provision of the mental health and substance use disorder benefits in the relevant classification.

(2) Conclusion. In this paragraph (c)(4)(viii)(A) (Example 1), the plan violates the rules of paragraph (c)(4)(i) of this section. Under the terms of the plan, prior authorization applies to at least two-thirds of all medical/surgical benefits in the relevant classification (inpatient, in-network), since it applies to all benefits in the relevant classification. Further, the most common or frequent variation of the nonquantitative treatment limitation applied to medical/surgical benefits in the relevant classification (the predominant nonquantitative treatment limitation) is the routine approval of inpatient, in-network benefits for 7 days before the patient’s attending provider must submit a treatment plan. However, the plan routinely approves inpatient, in-network benefits for mental health and substance use disorder conditions for only 1 day before the patient’s attending provider must submit a treatment plan (and, in doing so, does not impartially apply independent professional medical or clinical standards or apply standards to detect or prevent and prove fraud, waste, and abuse that qualify for the exceptions in paragraph (c)(4)(i)(E) of this section). In operation, therefore, the prior authorization requirement imposed on inpatient, in-network mental health and substance use disorder benefits is more restrictive than the predominant prior authorization requirement applicable to substantially all medical/surgical benefits in the inpatient, in-network classification because the practice of approving only 1 day of inpatient benefits limits access to the full range of treatment options available for a condition or disorder under the plan as compared to the routine 7-day approval that is given for inpatient, in-network medical/surgical benefits. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(B) Example 2 (More restrictive peer-to-peer concurrent review requirements in operation)—(1) Facts. A plan follows a written process for the concurrent review of all medical/surgical benefits and mental health and substance use disorder benefits within the inpatient, in-network classification. Under the process, a first-level review is conducted in every instance in which concurrent review applies and an authorization request is approved by the first-level reviewer only if the clinical information submitted by the facility meets the plan’s criteria for a continued stay. If the first-level reviewer is unable to approve the authorization request because the clinical information submitted by the facility does not meet the plan’s criteria for a continued stay, it is sent to a second-level reviewer who will either approve or deny the request. While the written process only requires review by the second-level reviewer to either deny or approve the request, in operation, second-level reviewers for mental health and substance use disorder benefits conduct a peer-to-peer review with a provider (acting as the authorized representative of a participant or beneficiary) before coverage of the treatment is approved. The peer-to-peer review requirement is not the result of independent professional medical or clinical standards or standards to detect or prevent and prove fraud, waste, and abuse. The plan does not impose a peer-to-peer review, as written or in operation, as part of the second-level review for medical/surgical benefits.

(2) Conclusion. In this paragraph (c)(4)(viii)(B) (Example 2), the plan violates the rules of paragraph (c)(4)(i) of this section. The concurrent review nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits within the inpatient, in-network classification because the plan follows the concurrent review process for all medical/surgical benefits. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is that peer-to-peer review is not imposed as part of second-level review. The plan does not impartially apply independent professional medical or clinical standards or apply standards to detect or prevent and prove fraud, waste, and abuse that qualify for the exceptions in paragraph (c)(4)(i)(E) of this section. As written, the plan’s concurrent review requirements are the same for medical/surgical benefits and mental health and substance use disorder benefits. However, in operation, by compelling an additional action (peer-to-peer review as part of second-level review) to access only mental health or substance use disorder benefits, the plan applies the limitation to mental health and substance use disorder benefits in a manner that is more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the inpatient, in-network classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(C) Example 3 (More restrictive peer-to-peer review medical necessity standard in operation; deviation from independent professional medical and clinical standards)—(1) Facts. A plan generally requires that all treatment be medically necessary in the inpatient, out-of-network classification. For both medical/surgical benefits and mental health and substance use disorder benefits, the written medical necessity standards are based on independent professional medical or clinical standards that do not require peer-to-peer review. In operation, the plan covers out-of-network benefits for medical/surgical or mental health inpatient treatment outside of a hospital if the physician documents medical appropriateness, but for out-of-network benefits for substance use disorder inpatient treatment outside of a hospital, the plan requires a physician to also complete peer-to-peer review.

(2) Conclusion. In this paragraph (c)(4)(viii)(C) (Example 3), the plan violates the rules of paragraph (c)(4)(i) of this section. The medical necessity nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits in the inpatient, out-of-network classification. The most common or frequent variation of the nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is the requirement that a physician document medical appropriateness without peer-to-peer review. The plan purports to impartially apply independent professional medical or clinical standards that would otherwise qualify for the exception in paragraph (c)(4)(i)(E) of this section, but deviates from those standards by imposing the additional requirement to complete peer-to-peer review for inpatient, out-of-network benefits for substance use disorder outside of a hospital. Therefore, the exception in paragraph (c)(4)(i)(E) of this section does not apply. As written, the plan provisions apply the nonquantitative treatment limitation to mental health and substance use disorder benefits in the inpatient, out-of-network classification in the same manner as for medical/surgical benefits. However, in operation, the nonquantitative treatment limitation imposed with respect to out-of-network substance use disorder benefits for treatment outside of a hospital is more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the classification because it limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(D) Example 4 (Not comparable and more stringent methods for determining reimbursement rates in operation)—(1) Facts. A plan’s base reimbursement rates for outpatient, in-network providers are determined based on a variety of factors, including the providers’ required training, licensure, and expertise. For purposes of this example, the plan’s nonquantitative treatment limitations for determining reimbursement rates for mental health and substance use disorder benefits are not more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the classification under paragraph (c)(4)(i) of this section. As written, for mental health, substance use disorder, and medical/surgical benefits, all reimbursement rates for physicians and non-physician practitioners for the same Current Procedural Terminology (CPT) code vary based on a combination of factors, such as the nature of the service, provider type, number of providers qualified to provide the service in a given geographic area, and market need (demand). As a result, reimbursement rates for mental health, substance use disorder, and medical/surgical benefits furnished by non-physician providers are generally less than for physician providers. In operation, the plan reduces the reimbursement rate for mental health and substance use disorder non-physician providers from that paid to mental health and substance use disorder physicians by the same percentage for every CPT code but does not apply the same reductions for non-physician medical/surgical providers.

(2) Conclusion. In this paragraph (c)(4)(viii)(D) (Example 4), the plan violates the rules of paragraph (c)(4)(ii) of this section. Because the plan reimburses non-physician providers of mental health and substance use disorder services by reducing their reimbursement rate from the rate to physician providers by the same percentage for every CPT code but does not apply the same reductions to non-physician providers of medical/surgical services, in operation, the factors used in applying the nonquantitative treatment limitation to mental health and substance use disorder benefits are not comparable to, and are applied more stringently than, the factors used in applying the limitation with respect to medical/surgical benefits. Because the facts assume that the plan’s methods for determining reimbursement rates comply with paragraph (c)(4)(i) of this section and the plan violates the rules of paragraph (c)(4)(ii) of this section, this example does not analyze compliance with paragraph (c)(4)(iv) of this section.

(E) Example 5 (Exception for impartially applied generally recognized independent professional medical or clinical standards)—(1) Facts. A group health plan develops a medical management requirement for all inpatient, out-of-network benefits for both medical/surgical benefits and mental health and substance use disorder benefits to ensure treatment is medically necessary. The medical management requirement impartially applies independent professional medical or clinical standards in a manner that qualifies for the exception in paragraph (c)(4)(i)(E) of this section. The plan does not rely on any other factors or evidentiary standards and the processes, strategies, evidentiary standards, and other factors used in designing and applying the medical management requirement to mental health and substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in designing and applying the requirement with respect to medical/surgical benefits. Within the inpatient, out-of-network classification, the application of the medical management requirement results in a higher percentage of denials for mental health and substance use disorder claims than medical/surgical claims, because the benefits were found to be medically necessary for a lower percentage of mental health and substance use disorder claims based on the impartial application of the independent professional medical or clinical standards by the nonquantitative treatment limitation.

(2) Conclusion. In this paragraph (c)(4)(viii)(E) (Example 5), the plan does not violate the rules of this paragraph (c)(4). The medical management nonquantitative treatment limitation imposed on mental health and substance use disorder benefits does not violate paragraph (c)(4)(i) or (iv) of this section because it impartially applies independent professional medical or clinical standards for both medical/surgical benefits and mental health and substance use disorder benefits in a manner that qualifies for the exceptions in paragraphs (c)(4)(i)(E) and (c)(4)(iv)(D) of this section, respectively. Moreover, the nonquantitative treatment limitation does not violate paragraph (c)(4)(ii) of this section because the independent professional medical or clinical standards are not considered to be a discriminatory factor or evidentiary standard under paragraph (c)(4)(ii)(B) of this section. Additionally, as written and in operation, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the inpatient, out-of-network classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in applying the limitation with respect to medical/surgical benefits in the classification, regardless of the fact that the application of the nonquantitative treatment limitation resulted in higher percentages of claim denials for mental health and substance use disorder benefits as compared to medical/surgical benefits.

(F) Example 6 (More restrictive prior authorization requirement; exception for impartially applied generally recognized independent professional medical or clinical standards not met)—(1) Facts. The provisions of a plan state that it applies independent professional medical and clinical standards (consistent with generally accepted standards of care) for setting prior authorization requirements for both medical/surgical and mental health and substance use disorder prescription drugs. The relevant generally recognized independent professional medical standard for treatment of opioid use disorder that the plan utilizes—in this case, the American Society of Addiction Medicine national practice guidelines—does not support prior authorization every 30 days for buprenorphine/naloxone. However, in operation, the plan requires prior authorization for buprenorphine/naloxone combination at each refill (every 30 days) for treatment of opioid use disorder.

(2) Conclusion. In this paragraph (c)(4)(viii)(F) (Example 6), the plan violates the rules of paragraph (c)(4)(i) of this section. The plan does not qualify for the exception in paragraph (c)(4)(i)(E) of this section, because, although the provisions of the plan state that it applies independent professional medical and clinical standards, the plan deviates from the relevant standards with respect to prescription drugs to treat opioid use disorder. The prior authorization nonquantitative treatment limitation is applied to at least two-thirds of all medical/surgical benefits in the prescription drugs classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is following generally recognized independent professional medical and clinical standards (consistent with generally accepted standards of care). The prior authorization requirements imposed on substance use disorder benefits are more restrictive than the predominant nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in the classification, because the plan imposes additional requirements on substance use disorder benefits that limit access to the full range of treatment options available for a condition or disorder under the plan as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(G) Example 7 (Impermissible nonquantitative treatment limitation imposed following a final determination of noncompliance and direction by the Secretary)—(1) Facts. Following an initial request by the Secretary for a plan’s comparative analysis of a nonquantitative treatment limitation pursuant to § 54.9812-2(d), the plan submits a comparative analysis for the nonquantitative treatment limitation. After review of the comparative analysis, the Secretary makes an initial determination that the comparative analysis fails to demonstrate that the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the relevant classification are comparable to, and applied no more stringently than, those used in designing and applying the limitation to medical/surgical benefits in the classification. Pursuant to § 54.9812-2(d)(3), the plan submits a corrective action plan and additional comparative analyses within 45 calendar days after the initial determination, and the Secretary then determines that the additional comparative analyses do not demonstrate compliance with the requirements of this paragraph (c)(4). The plan receives a final determination of noncompliance from the Secretary, which informs the plan that it is not in compliance with this paragraph (c)(4) and directs the plan not to impose the nonquantitative treatment limitation by a certain date, unless and until the plan demonstrates compliance to the Secretary or takes appropriate action to remedy the violation. The plan makes no changes to its plan terms by that date and continues to impose the nonquantitative treatment limitation.

(2) Conclusion. In this paragraph (c)(4)(viii)(G) (Example 7), the plan violates the requirements of this paragraph (c)(4) by imposing the nonquantitative treatment limitation after the Secretary directs the plan not to impose it, pursuant to paragraph (c)(4)(vii) of this section.

(H) Example 8 (Provider network admission standards not more restrictive and compliant with requirements for design and application of NQTLs)—(1) Facts. As part of a plan’s standards for provider admission to its network, in the outpatient, in-network classification, any provider seeking to contract with the plan must have a certain number of years of supervised clinical experience. As a result of that standard, master’s level mental health therapists are required to obtain supervised clinical experience beyond their licensure, while master’s level medical/surgical providers, psychiatrists, and Ph.D.-level psychologists do not require additional experience beyond their licensure because their licensure already requires supervised clinical experience. The plan collects and evaluates relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation. This includes in-network and out-of-network utilization rates (including data related to provider claim submissions), network adequacy metrics (including time and distance data, and data on providers accepting new patients), and provider reimbursement rates (including as compared to billed charges). This data demonstrates that participants and beneficiaries seeking outpatient care are able to access outpatient, in-network mental health and substance use disorder providers at the same frequency as outpatient, in-network medical/surgical providers, that mental health and substance use disorder providers are active in the network and are accepting new patients to the same extent as medical/surgical providers, and that mental health and substance use disorder providers are within similar time and distances to plan participants and beneficiaries as are medical/surgical providers. This data also does not identify material differences in what the plan pays psychiatrists or non-physician mental health providers, compared to physicians or non-physician medical/surgical providers, respectively, both for the same reimbursement codes and as compared to Medicare rates.

(2) Conclusion. In this paragraph (c)(4)(viii)(H) (Example 8), the plan does not violate this paragraph (c)(4). The standards for this nonquantitative treatment limitation, namely provider admission to the plan’s network, are applied to at least two-thirds of all medical/surgical benefits in the outpatient, in-network classification, as it applies to all medical/surgical benefits in the classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) that applies to substantially all medical/surgical benefits in the classification is having a certain number of years of supervised clinical experience. The standards for provider admission to the plan’s network that are imposed with respect to mental health or substance use disorder benefits are no more restrictive, as written or in operation, than the predominant variation of the nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in the classification, because the standards do not limit access to the full range of treatment options available for a condition or disorder under the plan as compared to medical/surgical benefits in the same classification. The requirement that providers have a certain number of years of supervised clinical experience that the plan relied upon to design and apply the nonquantitative treatment limitation is not considered to discriminate against mental health or substance use disorder benefits, even though this results in the requirement that master’s level mental health therapists obtain supervised clinical experience beyond their licensure, unlike master’s level medical/surgical providers. In addition, as written and in operation, the processes, strategies, evidentiary standards, or other factors used in applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying the limitation with respect to medical/surgical benefits in the classification, because the plan applies the same standard to all providers in the classification. Finally, the plan collects and evaluates relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation on access to mental health and substance use disorder benefits, which does not show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in the classification.

(I) Example 9 (More restrictive requirement for primary caregiver participation applied to ABA therapy)—(1) Facts. A plan generally applies medical necessity criteria in adjudicating claims for coverage of all outpatient, in-network medical/surgical and mental health and substance use disorder benefits, including ABA therapy for the treatment of ASD, which is a mental health condition. The plan’s medical necessity criteria for coverage of ABA therapy requires evidence that the participant’s or beneficiary’s primary caregivers actively participate in ABA therapy, as documented by consistent attendance in parent, caregiver, or guardian training sessions. In adding this requirement, the plan deviates from independent professional medical or clinical standards, and there are no similar medical necessity criteria requiring evidence of primary caregiver participation in order to receive coverage of any medical/surgical benefits.

(2) Conclusion. In this paragraph (c)(4)(viii)(I) (Example 9), the plan violates paragraph (c)(4)(i) of this section. The plan applies medical necessity criteria to at least two-thirds of all outpatient, in-network medical/surgical benefits, as they apply to all medical/surgical benefits in the classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) that applies to substantially all medical/surgical benefits in the classification does not include the requirement to provide evidence that the participant’s or beneficiary’s primary caregivers actively participate in the treatment. The plan does not qualify for the exception in paragraph (c)(4)(i)(E) of this section in applying its restriction on coverage for ABA therapy because the plan deviates from the independent professional medical or clinical standards by imposing a different requirement. As a result, the nonquantitative treatment limitation imposed on mental health and substance use disorder benefits is more restrictive than the predominant medical necessity requirement imposed on substantially all medical/surgical benefits in the classification (which does not include the requirement to provide evidence that primary caregivers actively participate in treatment). Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(J) Example 10 (More restrictive exclusion for experimental or investigative treatment applied to ABA therapy)—(1) Facts. A plan, as written, generally excludes coverage for all treatments that are experimental or investigative for both medical/surgical benefits and mental health and substance use disorder benefits in the outpatient, in-network classification. As a result, the plan generally excludes experimental treatment of medical conditions and surgical procedures, mental health conditions, and substance use disorders when no professionally recognized treatment guidelines define clinically appropriate standards of care for the condition or disorder and fewer than two randomized controlled trials are available to support the treatment’s use with respect to the given condition or disorder. The plan provides benefits for the treatment of ASD, which is a mental health condition, but, in operation, the plan excludes coverage for ABA therapy to treat children with ASD, deeming it experimental. More than one professionally recognized treatment guideline defines clinically appropriate standards of care for ASD and more than two randomized controlled trials are available to support the use of ABA therapy to treat certain children with ASD.

(2) Conclusion. In this paragraph (c)(4)(viii)(J) (Example 10), the plan violates the rules of paragraph (c)(4)(i) of this section. The coverage exclusion for experimental or investigative treatment applies to at least two-thirds of all medical/surgical benefits, as it applies to all medical/surgical benefits in the outpatient, in-network classification. The most common or frequent variation of this nonquantitative treatment limitation in the classification (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is the exclusion under the plan for coverage of experimental treatment of medical/surgical conditions when no professionally recognized treatment guidelines define clinically appropriate standards of care for the condition or disorder and fewer than two randomized controlled trials are available to support the treatment’s use with respect to the given condition or procedure. In operation, the exclusion for experimental or investigative treatment imposed on ABA therapy is more restrictive than the predominant variation of the nonquantitative treatment limitation for experimental or investigative treatment imposed on substantially all medical/surgical benefits in the classification because the exclusion limits access to the full range of treatment options available for a condition or disorder under the plan as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(K) Example 11 (Separate EAP exhaustion treatment limitation applicable only to mental health benefits)—(1) Facts. An employer maintains both a major medical plan and an employee assistance program (EAP). The EAP provides, among other benefits, a limited number of mental health or substance use disorder counseling sessions, which, together with other benefits provided by the EAP, are not significant benefits in the nature of medical care. Participants are eligible for mental health or substance use disorder benefits under the major medical plan only after exhausting the counseling sessions provided by the EAP. No similar exhaustion requirement applies with respect to medical/surgical benefits provided under the major medical plan.

(2) Conclusion. In this paragraph (c)(4)(viii)(K) (Example 11), limiting eligibility for mental health and substance use disorder benefits under the major medical plan until EAP benefits are exhausted is a nonquantitative treatment limitation subject to the parity requirements of this paragraph (c). Because the limitation does not apply to medical/surgical benefits, it is a separate nonquantitative treatment limitation applicable only to mental health and substance use disorder benefits that violates paragraph (c)(4)(vi) of this section. Additionally, this EAP would not qualify as excepted benefits under §54.9831-1(c)(3)(vi)(B)(1) because participants in the major medical plan are required to use and exhaust benefits under the EAP (making the EAP a gatekeeper) before an individual is eligible for benefits under the plan.

(L) Example 12 (Separate residential exclusion treatment limitation applicable only to mental health benefits)—(1) Facts. A plan generally covers inpatient, in-network and inpatient out-of-network treatment in any setting, including skilled nursing facilities and rehabilitation hospitals, provided other medical necessity standards are satisfied. The plan also has an exclusion for residential treatment, which the plan defines as an inpatient benefit, for mental health and substance use disorder benefits. This exclusion was not generated through any broader nonquantitative treatment limitation (such as medical necessity or other clinical guideline).

(2) Conclusion. In this paragraph (c)(4)(viii)(L) (Example 12), the plan violates the rules of paragraph (c)(4)(vi) of this section. Because the plan does not apply a comparable exclusion to inpatient benefits for medical/surgical conditions, the exclusion of residential treatment is a separate nonquantitative treatment limitation applicable only to mental health and substance use disorder benefits in the inpatient, in-network and inpatient, out-of-network classifications that does not apply with respect to any medical/surgical benefits in the same benefit classification.

(M) Example 13 (Standards for provider admission to a network)—(1) Facts. A plan applies nonquantitative treatment limitations related to network composition in the outpatient in-network and inpatient, in-network classifications. The plan’s networks are constructed by separate service providers for medical/surgical benefits and mental health and substance use disorder benefits. For purposes of this example, these facts assume that these nonquantitative treatment limitations related to network composition for mental health and substance use disorder benefits are not more restrictive than the predominant nonquantitative treatment limitations applied to substantially all medical/surgical benefits in the classifications under paragraph (c)(4)(i) of this section. The facts also assume that, as written and in operation, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitations related to network access to mental health or substance use disorder benefits in the outpatient in-network and inpatient in-network classifications are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitations with respect to medical/surgical benefits in the classifications, as required under paragraph (c)(4)(ii) of this section. The plan collects and evaluates all relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitations related to network composition on access to mental health and substance use disorder benefits as compared with access to medical/surgical benefits and considers the impact as part of the plan’s analysis of whether the standards, in operation, comply with paragraphs (c)(4)(i) and (ii) of this section. The plan determined that the data did not reveal any material differences in access. That data included metrics relating to the time and distance from plan participants and beneficiaries to network providers in rural and urban regions; the number of network providers accepting new patients; the proportions of mental health and substance use disorder and medical/surgical providers and facilities that provide services in rural and urban regions who are in the plan’s network; provider reimbursement rates; in-network and out-of-network utilization rates (including data related to the dollar value and number of provider claims submissions); and survey data from participants on the extent to which they forgo or pay out-of-pocket for treatment because of challenges finding in-network providers. The efforts the plan made when designing and applying its nonquantitative treatment limitations related to network composition, which ultimately led to its outcomes data not revealing any material differences in access to benefits for mental health or substance use disorders as compared with medical/surgical benefits, included making sure that the plan’s service providers are making special efforts to enroll available providers, including by authorizing greater compensation or other inducements to the extent necessary, and expanding telehealth arrangements as appropriate to manage regional shortages. The plan also notifies participants in clear and prominent language on its website, employee brochures, and the summary plan description of a toll-free number available to help participants find in-network providers. In addition, when plan participants submit bills for out-of-network items and services, the plan directs their service providers to reach out to the treating providers and facilities to see if they will enroll in the network.

(2) Conclusion. In this paragraph (c)(4)(viii)(M) (Example 13), the plan does not violate this paragraph (c)(4). As stated in the Facts section, the plan’s nonquantitative treatment limitations related to network composition comply with the rules of paragraphs (c)(4)(i) and (ii) of this section. The plan collects and evaluates relevant data, as required under paragraph (c)(4)(iv)(A) of this section, and the data does not reveal any material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, as a result of the actions the plan took (as set forth in the facts) when initially designing its nonquantitative treatment limitations related to network composition. Because the plan takes comparable actions to ensure that their mental health and substance use disorder provider network is as accessible as their medical/surgical provider network and exercises careful oversight over both their service providers and the comparative robustness of the networks with an eye to ensuring that network composition results in access to in-network benefits for mental health and substance use disorder services that is as generous as for medical/surgical services, plan participants and beneficiaries can access covered mental health and substance use disorder services and benefits as readily as medical/surgical benefits. This is reflected in the plan’s carefully designed metrics and assessment of network composition.

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(d) * * *

(3) Provisions of other law. Compliance with the disclosure requirements in paragraphs (d)(1) and (2) of this section is not determinative of compliance with any other provision of applicable Federal or State law. In particular, in addition to those disclosure requirements, provisions of other applicable law require disclosure of information relevant to medical/surgical, mental health, and substance use disorder benefits. For example, ERISA section 104 and 29 CFR 2520.104b-1 provide that, for plans subject to ERISA, instruments under which the plan is established or operated must generally be furnished to plan participants within 30 days of request. Instruments under which the plan is established or operated include documents with information on medical necessity criteria for both medical/surgical benefits and mental health and substance use disorder benefits; the processes, strategies, evidentiary standards, and other factors used to apply a nonquantitative treatment limitation with respect to medical/surgical benefits and mental health or substance use disorder benefits under the plan; and the comparative analyses and other applicable information required by § 54.9812-2. In addition, 29 CFR 2560.503-1 and § 54.9815-2719T set forth rules regarding claims and appeals, including the right of claimants (or their authorized representative) upon appeal of an adverse benefit determination (or a final internal adverse benefit determination) to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the claimant’s claim for benefits. This includes documents with information on medical necessity criteria for both medical/surgical benefits and mental health and substance use disorder benefits, as well as the processes, strategies, evidentiary standards, and other factors used to apply a nonquantitative treatment limitation with respect to medical/surgical benefits and mental health or substance use disorder benefits under the plan and the comparative analyses and other applicable information required by § 54.9812-2.

(e) * * *

(4) Coordination with EHB requirements. Nothing in paragraph (f) or (g) of this section or § 54.9812-2(g) changes the requirements of 45 CFR 147.150 and 156.115, providing that a health insurance issuer offering non-grandfathered health insurance coverage in the individual or small group market providing mental health and substance use disorder services, including behavioral health treatment services, as part of essential health benefits required under 45 CFR 156.110(a)(5) and 156.115(a), must comply with the requirements under section 2726 of the Public Health Service Act and its implementing regulations to satisfy the requirement to provide coverage for mental health and substance use disorder services, including behavioral health treatment, as part of essential health benefits.

* * * * *

(i) * * *

(1) In general. Except as provided in paragraph (i)(2) of this section, this section applies to group health plans on the first day of the first plan year beginning on or after January 1, 2025. Until the applicability date in the preceding sentence, plans are required to continue to comply with 26 CFR 54.9812-1, revised as of April 1, 2023.

* * * * *

(j) Severability. If any provision of this section is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, the provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

3. Add § 54.9812-2 to read as follows:

(a) Meaning of terms. Unless otherwise stated in this section, the terms of this section have the meanings indicated in § 54.9812-1(a)(2).

(b) In general. In the case of a group health plan that provides both medical/surgical benefits and mental health or substance use disorder benefits and that imposes any nonquantitative treatment limitation on mental health or substance use disorder benefits, the plan must perform and document a comparative analysis of the design and application of each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits. Each comparative analysis must comply with the content requirements of paragraph (c) of this section and be made available to the Secretary, upon request, in the manner required by paragraphs (d) and (e) of this section.

(c) Comparative analysis content requirements. With respect to each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits under a group health plan, the comparative analysis performed by the plan must include, at minimum, the elements specified in this paragraph (c). In addition to the comparative analysis for each nonquantitative treatment limitation, each plan must prepare and make available to the Secretary, upon request, a written list of all nonquantitative treatment limitations imposed under the plan and a general description of any information considered or relied upon by the plan in preparing the comparative analysis for each nonquantitative treatment limitation.

(1) Description of the nonquantitative treatment limitation. The comparative analysis must include, with respect to the nonquantitative treatment limitation that is the subject of the comparative analysis:

(i) Identification of the nonquantitative treatment limitation, including the specific terms of the plan or other relevant terms regarding the nonquantitative treatment limitation, the policies or guidelines (internal or external) in which the nonquantitative treatment limitation appears or is described, and the applicable sections of any other relevant documents, such as provider contracts, that describe the nonquantitative treatment limitation;

(ii) Identification of all mental health or substance use disorder benefits and medical/surgical benefits to which the nonquantitative treatment limitation applies, including a list of which benefits are considered mental health or substance use disorder benefits and which benefits are considered medical/surgical benefits;

(iii) A description of which benefits are included in each classification set forth in § 54.9812-1(c)(2)(ii)(A); and

(iv) Identification of the predominant nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in each classification, including an explanation of how the plan determined which variation is the predominant nonquantitative treatment limitation as compared to other variations, as well as how the plan identified the variations of the nonquantitative treatment limitation.

(2) Identification and definition of the factors used to design or apply the nonquantitative treatment limitation. The comparative analysis must include, with respect to every factor considered or relied upon to design the nonquantitative treatment limitation or apply the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits:

(i) Identification of all of the factors considered, as well as the evidentiary standards considered or relied upon to design or apply each factor and the sources from which each evidentiary standard was derived, in determining which mental health or substance use disorder benefits and which medical/surgical benefits are subject to the nonquantitative treatment limitation; and

(ii) A definition of each factor, including:

(A) A detailed description of the factor; and

(B) A description of each evidentiary standard (and the source of each evidentiary standard) identified under paragraph (c)(2)(i) of this section.

(3) Description of how factors are used in the design and application of the nonquantitative treatment limitation. The comparative analysis must include a description of how each factor identified and defined pursuant to paragraph (c)(2) of this section is used in the design or application of the nonquantitative treatment limitation to mental health and substance use disorder benefits and medical/surgical benefits in a classification, including:

(i) A detailed explanation of how each factor identified and defined in paragraph (c)(2) of this section is used to determine which mental health or substance use disorder benefits and which medical/surgical benefits are subject to the nonquantitative treatment limitation;

(ii) An explanation of the evidentiary standards or other information or sources (if any) considered or relied upon in designing or applying the factors or relied upon in designing and applying the nonquantitative treatment limitation, including in the determination of whether and how mental health or substance use disorder benefits or medical/surgical benefits are subject to the nonquantitative treatment limitation;

(iii) If the application of the factor depends on specific decisions made in the administration of benefits, the nature of the decisions, the timing of the decisions, and the professional designation and qualifications of each decision maker;

(iv) If more than one factor is identified and defined in paragraph (c)(2) of this section, an explanation of:

(A) How all of the factors relate to each other;

(B) The order in which all the factors are applied, including when they are applied;

(C) Whether and how any factors are given more weight than others; and

(D) The reasons for the ordering or weighting of the factors; and

(v) Any deviation(s) or variation(s) from a factor, its applicability, or its definition (including the evidentiary standards used to define the factor and the information or sources from which each evidentiary standard was derived), such as how the factor is used differently to apply the nonquantitative treatment limitation to mental health or substance use disorder benefits as compared to medical/surgical benefits, and a description of how the plan establishes such deviation(s) or variation(s).

(4) Demonstration of comparability and stringency as written. The comparative analysis must evaluate whether, in any classification, under the terms of the plan as written, any processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder 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 nonquantitative treatment limitation with respect to medical/surgical benefits. The comparative analysis must include, with respect to the nonquantitative treatment limitation and the factors used in designing and applying the nonquantitative treatment limitation:

(i) Documentation of each factor identified and defined in paragraph (c)(2) of this section that was applied to determine whether the nonquantitative treatment limitation applies to mental health or substance use disorder benefits and medical/surgical benefits in a classification, including, as relevant:

(A) Quantitative data, calculations, or other analyses showing whether, in each classification in which the nonquantitative treatment limitation applies, mental health or substance use disorder benefits and medical/surgical benefits met or did not meet any applicable threshold identified in the relevant evidentiary standard, and the evaluation of relevant data as required under § 54.9812-1(c)(4)(iv)(A), to determine that the nonquantitative treatment limitation would or would not apply; and

(B) Records maintained by the plan documenting the consideration and application of all factors and evidentiary standards, as well as the results of their application;

(ii) In each classification in which the nonquantitative treatment limitation applies to mental health or substance use disorder benefits, a comparison of how the nonquantitative treatment limitation, as written, is applied to mental health or substance use disorder benefits and to medical/surgical benefits, including the specific provisions of any forms, checklists, procedure manuals, or other documentation used in designing and applying the nonquantitative treatment limitation or that address the application of the nonquantitative treatment limitation;

(iii) Documentation demonstrating how the factors are comparably applied, as written, to mental health or substance use disorder benefits and medical/surgical benefits in each classification, to determine which benefits are subject to the nonquantitative treatment limitation; and

(iv) An explanation of the reason(s) for any deviation(s) or variation(s) in the application of a factor used to apply the nonquantitative treatment limitation, or the application of the nonquantitative treatment limitation, to mental health or substance use disorder benefits as compared to medical/surgical benefits, and how the plan establishes such deviation(s) or variation(s), including:

(A) In the definition of the factors, the evidentiary standards used to define the factors, and the sources from which the evidentiary standards were derived;

(B) In the design of the factors or evidentiary standards; or

(C) In the application or design of the nonquantitative treatment limitation.

(5) Demonstration of comparability and stringency in operation. The comparative analysis must evaluate whether, in any classification, under the terms of the plan in operation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder 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. The comparative analysis must include, with respect to the nonquantitative treatment limitation and the factors used in designing and applying the nonquantitative treatment limitation:

(i) A comprehensive explanation of how the plan ensures that, in operation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in a classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation with respect to medical/surgical benefits, including:

(A) An explanation of any methodology and underlying data used to demonstrate the application of the nonquantitative treatment limitation, in operation; and

(B) The sample period, inputs used in any calculations, definitions of terms used, and any criteria used to select the mental health or substance use disorder benefits and medical/surgical benefits to which the nonquantitative treatment limitation is applicable;

(ii) Identification of the relevant data collected and evaluated as required under § 54.9812-1(c)(4)(iv)(A);

(iii) An evaluation of the outcomes that resulted from the application of the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits, including the relevant data as required under § 54.9812-1(c)(4)(iv)(A);

(iv) A detailed explanation of material differences in outcomes evaluated pursuant to paragraph (c)(5)(iii) of this section that are not attributable to differences in the comparability or relative stringency of the nonquantitative treatment limitation as applied to mental health or substance use disorder benefits and medical/surgical benefits and the bases for concluding that material differences in outcomes are not attributable to differences in the comparability or relative stringency of the nonquantitative treatment limitation; and

(v) A discussion of any measures that have been or are being implemented by the plan to mitigate any material differences in access to mental health or substance use disorder benefits as compared to medical/surgical benefits, including the actions the plan is taking under § 54.9812-1(c)(4)(iv)(B)(1) to address material differences to ensure compliance with § 54.9812-1(c)(4)(i) and (ii).

(6) Findings and conclusions. The comparative analysis must address the findings and conclusions as to the comparability of the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits within each classification, and the relative stringency of their application, both as written and in operation, and include:

(i) Any findings or conclusions indicating that the plan is not (or might not be) in compliance with the requirements of § 54.9812-1(c)(4), including any actions the plan has taken or intends to take to address any potential areas of concern or noncompliance;

(ii) A reasoned and detailed discussion of the findings and conclusions described in paragraph (c)(6)(i) of this section;

(iii) Citations to any additional specific information not otherwise included in the comparative analysis that supports the findings and conclusions described in paragraph (c)(6)(i) of this section;

(iv) The date of the analysis and the title and credentials of all relevant persons who participated in the performance and documentation of the comparative analysis; and

(v) If the comparative analysis relies upon an evaluation by a reviewer or consultant considered by the plan to be an expert, an assessment of each expert’s qualifications and the extent to which the plan ultimately relied upon each expert’s evaluation in performing and documenting the comparative analysis of the design and application of each nonquantitative treatment limitation applicable to both mental health or substance use disorder benefits and medical/surgical benefits.

(d) Requirements related to submission of comparative analyses to the Secretary upon request—(1) Initial request by the Secretary for comparative analysis. A group health plan must make the comparative analysis required by paragraph (b) of this section available and submit it to the Secretary within 10 business days of receipt of a request from the Secretary (or an additional period of time specified by the Secretary).

(2) Additional information required after a comparative analysis is deemed to be insufficient. In instances in which the Secretary determines that the plan has not submitted sufficient information under paragraph (d)(1) of this section for the Secretary to review the comparative analysis required in paragraph (b) of this section, the Secretary will specify to the plan the additional information the plan must submit to the Secretary to be responsive to the request under paragraph (d)(1) of this section. Any such information must be provided to the Secretary by the plan within 10 business days after the Secretary specifies the additional information to be submitted (or an additional period of time specified by the Secretary).

(3) Initial determination of noncompliance, required action, and corrective action plan. In instances in which the Secretary reviewed the comparative analysis submitted under paragraph (d)(1) of this section and any additional information submitted under paragraph (d)(2) of this section, and made an initial determination that the plan is not in compliance with the requirements of § 54.9812-1(c)(4) or this section, the plan must respond to the Secretary and specify the actions the plan will take to bring the plan into compliance, and provide to the Secretary additional comparative analyses meeting the requirements of paragraph (b) of this section that demonstrate compliance with § 54.9812-1(c)(4) and this section, not later than 45 calendar days after the Secretary’s initial determination that the plan is not in compliance.

(4) Requirement to notify participants and beneficiaries of final determination of noncompliance—(i) In general. If the Secretary makes a final determination of noncompliance, the plan must notify all participants and beneficiaries enrolled in the plan that the plan has been determined to not be in compliance with the requirements of § 54.9812-1(c)(4) or this section with respect to such plan. Such notice must be provided within 7 calendar days of receipt of the final determination of noncompliance, and the plan must provide a copy of the notice to the Secretary, and any service provider involved in the claims process.

(ii) Content of notice. The notice to participants and beneficiaries required in paragraph (d)(4)(i) of this section shall be written in a manner calculated to be understood by the average plan participant and must include, in plain language, the following information in a standalone notice:

(A) The following statement prominently displayed on the first page, in no less than 14-point font: “Attention! Department of the Treasury has determined that [insert the name of group health plan] is not in compliance with the Mental Health Parity and Addiction Equity Act.”;

(B) A summary of changes the plan has made as part of its corrective action plan specified to the Secretary following the initial determination of noncompliance, including an explanation of any opportunity for a participant or beneficiary to have a claim for benefits reprocessed;

(C) A summary of the Secretary’s final determination that the plan is not in compliance with § 54.9812-1(c)(4) or this section, including any provisions or practices identified as being in violation of MHPAEA, additional corrective actions identified by the Secretary in the final determination notice, and information on how participants and beneficiaries can obtain from the plan a copy of the final determination of noncompliance;

(D) Any additional actions the plan is taking to come into compliance with § 54.9812-1(c)(4) or this section, when the plan will take such actions, and a clear and accurate statement explaining whether the Secretary has indicated that those actions, if completed, will result in compliance; and

(E) Contact information for questions and complaints, and a statement explaining how participants and beneficiaries can obtain more information about the notice, including:

(1) The plan’s phone number and an email or web portal address; and

(2) The Employee Benefits Security Administration’s phone number and email or web portal address.

(iii) Manner of notice. The plan must make the notice required under paragraph (d)(4)(i) of this section available in paper form, or electronically (such as by email or an Internet posting) if:

(A) The format is readily accessible;

(B) The notice is provided in paper form free of charge upon request; and

(C) In a case in which the electronic form is an internet posting, the plan timely notifies the participant or beneficiary in paper form (such as a postcard) or email, that the documents are available on the internet, provides the internet address, includes the statement required in paragraph (d)(4)(ii)(A) of this section, and notifies the participant or beneficiary that the documents are available in paper form upon request.

(e) Requests for a copy of a comparative analysis. In addition to making a comparative analysis available upon request to the Secretary, a plan must make available a copy of the comparative analysis required by paragraph (b) of this section when requested by:

(1) Any applicable State authority; and

(2) A participant or beneficiary (or a provider or other person acting as a participant’s or beneficiary’s authorized representative) who has received an adverse benefit determination related to mental health or substance use disorder benefits.

(f) Rule of construction. Nothing in this section or § 54.9812-1 shall be construed to prevent the Secretary from acting within the scope of existing authorities to address violations of § 54.9812-1 or this section.

(g) Applicability. The provisions of this section apply to group health plans described in § 54.9812-1(e), to the extent the plan is not exempt under § 54.9812-1(f) or (g), for plan years beginning on or after January 1, 2025.

(h) Severability. If any provision of this section is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, the provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

29 CFR Chapter XXV

For the reasons set forth in the preamble, the Department of Labor proposes to amend 29 CFR part 2590 as set forth below:

4. The authority citation for part 2590 continues to read as follows:

Authority: 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a-n, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L.104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029; Division M, Pub. L. 113-235, 128 Stat. 2130; Pub. L. 116-260 134 Stat. 1182; Secretary of Labor’s Order 1-2011, 77 FR 1088 (Jan. 9, 2012).

5. Amend § 2590.712 by:

a. Redesignating paragraph (a) as paragraph (a)(2) and adding paragraphs (a) heading and (a)(1);

b. In newly redesignated paragraph (a)(2):

i. Revising the introductory text;

ii. Adding the definitions of “DSM,” “Evidentiary standards,” “Factors,” and “ICD” in alphabetical order;

iii. Revising the definitions of “Medical/surgical benefits” and “Mental health benefits”;

iv. Adding the definitions of “Processes” and “Strategies” in alphabetical order; and

v. Revising the definitions of “Substance use disorder benefits” and “Treatment limitations”;

c. Revising paragraphs (c)(1)(ii), (c)(2)(i), and (c)(2)(ii)(A) introductory text;

d. In paragraph (c)(2)(ii)(C), designating Examples 1 through 4 as paragraphs (c)(2)(ii)(C)(1) through (4) and revising newly designated paragraphs (c)(2)(ii)(C)(1) through (4);

e. Adding paragraphs (c)(2)(ii)(C)(5) and (6);

f. Revising paragraphs (c)(3)(i)(A), (C), and (D);

g. In paragraph (c)(3)(iii), adding introductory text;

h. Revising paragraphs (c)(3)(iii)(A) and (B), (c)(3)(iv), (c)(4), (d)(3), (e)(4), and (i)(1); and

i. Adding paragraph (j).

The revisions and additions read as follows:

(a) Purpose and meaning of terms—(1) Purpose. This section and § 2590.712-1 set forth rules to ensure parity in aggregate lifetime and annual dollar limits, financial requirements, and quantitative and nonquantitative treatment limitations between mental health and substance use disorder benefits and medical/surgical benefits, as required under ERISA section 712. A fundamental purpose of ERISA section 712, this section, and § 2590.712-1 is to ensure that participants and beneficiaries in a group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) that offers mental health or substance use disorder benefits are not subject to more restrictive lifetime or annual dollar limits, financial requirements, or treatment limitations with respect to those benefits than the predominant dollar limits, financial requirements, or treatment limitations that are applied to substantially all medical/surgical benefits covered by the plan or coverage, as further provided in this section and § 2590.712-1. Accordingly, in complying with the provisions of ERISA section 712, this section, and § 2590.712-1, plans and issuers must not design or apply financial requirements and treatment limitations that impose a greater burden on access (that is, are more restrictive) to mental health and substance use disorder benefits under the plan or coverage than they impose on access to generally comparable medical/surgical benefits. The provisions of ERISA section 712, this section, and § 2590.712-1 should be interpreted in a manner that is consistent with the purpose described in this paragraph (a)(1).

(2) Meaning of terms. For purposes of this section and § 2590.712-1, except where the context clearly indicates otherwise, the following terms have the meanings indicated:

* * * * *

DSM means the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders. For the purpose of this definition, the most current version of the DSM is the version that is applicable no earlier than on the date that is 1 year before the first day of the applicable plan year.

Evidentiary standards are any evidence, sources, or standards that a group health plan (or health insurance issuer offering coverage in connection with such a plan) considered or relied upon in designing or applying a factor with respect to a nonquantitative treatment limitation, including specific benchmarks or thresholds. Evidentiary standards may be empirical, statistical, or clinical in nature, and include: sources acquired or originating from an objective third party, such as recognized medical literature, professional standards and protocols (which may include comparative effectiveness studies and clinical trials), published research studies, payment rates for items and services (such as publicly available databases of the “usual, customary and reasonable” rates paid for items and services), and clinical treatment guidelines; internal plan or issuer data, such as claims or utilization data or criteria for assuring a sufficient mix and number of network providers; and benchmarks or thresholds, such as measures of excessive utilization, cost levels, time or distance standards, or network participation percentage thresholds.

Factors are all information, including processes and strategies (but not evidentiary standards), that a group health plan (or health insurance issuer offering coverage in connection with such a plan) considered or relied upon to design a nonquantitative treatment limitation, or to determine whether or how the nonquantitative treatment limitation applies to benefits under the plan or coverage. Examples of factors include, but are not limited to: provider discretion in determining a diagnosis or type or length of treatment; clinical efficacy of any proposed treatment or service; licensing and accreditation of providers; claim types with a high percentage of fraud; quality measures; treatment outcomes; severity or chronicity of condition; variability in the cost of an episode of treatment; high cost growth; variability in cost and quality; elasticity of demand; and geographic location.

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ICD means the World Health Organization’s International Classification of Diseases adopted by the Department of Health and Human Services through 45 CFR 162.1002. For the purpose of this definition, the most current version of the ICD is the version that is applicable no earlier than on the date that is 1 year before the first day of the applicable plan year.

Medical/surgical benefits means benefits with respect to items or services for medical conditions or surgical procedures, as defined under the terms of the group health plan (or health insurance coverage offered by an issuer in connection with such a plan) and in accordance with applicable Federal and State law, but does not include mental health benefits or substance use disorder benefits. Notwithstanding the preceding sentence, any condition or procedure defined by the plan or coverage as being or as not being a medical condition or surgical procedure must be defined consistent with generally recognized independent standards of current medical practice (for example, the most current version of the ICD). To the extent generally recognized independent standards of current medical practice do not address whether a condition or procedure is a medical condition or surgical procedure, plans and issuers may define the condition or procedure in accordance with applicable Federal and State law.

Mental health benefits means benefits with respect to items or services for mental health conditions, as defined under the terms of the group health plan (or health insurance coverage offered by an issuer in connection with such a plan) and in accordance with applicable Federal and State law, but does not include medical/surgical benefits or substance use disorder benefits. Notwithstanding the preceding sentence, any condition defined by the plan or coverage as being or as not being a mental health condition must be defined consistent with generally recognized independent standards of current medical practice. For the purpose of this definition, to be consistent with generally recognized independent standards of current medical practice, the definition must include all conditions covered under the plan or coverage, except for substance use disorders, that fall under any of the diagnostic categories listed in the mental, behavioral, and neurodevelopmental disorders chapter (or equivalent chapter) of the most current version of the ICD or that are listed in the most current version of the DSM. To the extent generally recognized independent standards of current medical practice do not address whether a condition is a mental health condition, plans and issuers may define the condition in accordance with applicable Federal and State law.

Processes are actions, steps, or procedures that a group health plan (or health insurance issuer offering coverage in connection with such a plan) uses to apply a nonquantitative treatment limitation, including actions, steps, or procedures established by the plan or issuer as requirements in order for a participant or beneficiary to access benefits, including through actions by a participant’s or beneficiary’s authorized representative or a provider or facility. Processes include but are not limited to: procedures to submit information to authorize coverage for an item or service prior to receiving the benefit or while treatment is ongoing (including requirements for peer or expert clinical review of that information); provider referral requirements; and the development and approval of a treatment plan. Processes also include the specific procedures used by staff or other representatives of a plan or issuer (or the service provider of a plan or issuer) to administer the application of nonquantitative treatment limitations, such as how a panel of staff members applies the nonquantitative treatment limitation (including the qualifications of staff involved, number of staff members allocated, and time allocated), consultations with panels of experts in applying the nonquantitative treatment limitation, and reviewer discretion in adhering to criteria hierarchy when applying a nonquantitative treatment limitation.

Strategies are practices, methods, or internal metrics that a plan (or health insurance issuer offering coverage in connection with such a plan) considers, reviews, or uses to design a nonquantitative treatment limitation. Examples of strategies include but are not limited to: the development of the clinical rationale used in approving or denying benefits; deviation from generally accepted standards of care; the selection of information deemed reasonably necessary to make a medical necessity determination; reliance on treatment guidelines or guidelines provided by third-party organizations; and rationales used in selecting and adopting certain threshold amounts, professional protocols, and fee schedules. Strategies also include the creation and composition of the staff or other representatives of a plan or issuer (or the service provider of a plan or issuer) that deliberates, or otherwise makes decisions, on the design of nonquantitative treatment limitations, including the plan’s decisions related to the qualifications of staff involved, number of staff members allocated, and time allocated; breadth of sources and evidence considered; consultations with panels of experts in designing the nonquantitative treatment limitation; and the composition of the panels used to design a nonquantitative treatment limitation.

Substance use disorder benefits means benefits with respect to items or services for substance use disorders, as defined under the terms of the group health plan (or health insurance coverage offered by an issuer in connection with such a plan) and in accordance with applicable Federal and State law, but does not include medical/surgical benefits or mental health benefits. Notwithstanding the preceding sentence, any disorder defined by the plan or coverage as being or as not being a substance use disorder must be defined consistent with generally recognized independent standards of current medical practice. For the purpose of this definition, to be consistent with generally recognized independent standards of current medical practice, the definition must include all disorders covered under the plan or coverage that fall under any of the diagnostic categories listed as a mental or behavioral disorder due to psychoactive substance use (or equivalent category) in the mental, behavioral and neurodevelopmental disorders chapter (or equivalent chapter) of the most current version of the ICD or that are listed as a Substance-Related and Addictive Disorder (or equivalent category) in the most current version of the DSM. To the extent generally recognized independent standards of current medical practice do not address whether a disorder is a substance use disorder, plans and issuers may define the disorder in accordance with applicable Federal and State law.

Treatment limitations include limits on benefits based on the frequency of treatment, number of visits, days of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. Treatment limitations include both quantitative treatment limitations, which are expressed numerically (such as 50 outpatient visits per year), and nonquantitative treatment limitations, which otherwise limit the scope or duration of benefits for treatment under a plan or coverage. (See paragraph (c)(4)(iii) of this section for an illustrative, non-exhaustive list of nonquantitative treatment limitations.) A complete exclusion of all benefits for a particular condition or disorder, however, is not a treatment limitation for purposes of this definition.

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(c) * * *

(1) * * *

(ii) Type of financial requirement or treatment limitation. When reference is made in this paragraph (c) to a type of financial requirement or treatment limitation, the reference to type means its nature. Different types of financial requirements include deductibles, copayments, coinsurance, and out-of-pocket maximums. Different types of quantitative treatment limitations include annual, episode, and lifetime day and visit limits. See paragraph (c)(4)(iii) of this section for an illustrative, non-exhaustive list of nonquantitative treatment limitations.

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(2) * * *

(i) General rule. A group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) that provides both medical/surgical benefits and mental health or substance use disorder benefits may not apply any financial requirement or treatment limitation to mental health or substance use disorder benefits in any classification that is more restrictive than the predominant financial requirement or treatment limitation of that type applied to substantially all medical/surgical benefits in the same classification. Whether a financial requirement or treatment limitation is a predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in a classification is determined separately for each type of financial requirement or treatment limitation. A plan or issuer may not impose any financial requirement or treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and not to any medical/surgical benefits in the same benefit classification. The application of the rules of this paragraph (c)(2) to financial requirements and quantitative treatment limitations is addressed in paragraph (c)(3) of this section; the application of the rules of this paragraph (c)(2) to nonquantitative treatment limitations is addressed in paragraph (c)(4) of this section.

(ii) * * *

(A) In general. If a plan (or health insurance coverage) provides any benefits for a mental health condition or substance use disorder in any classification of benefits described in this paragraph (c)(2)(ii), benefits for that mental health condition or substance use disorder must be provided in every classification in which medical/surgical benefits are provided. For purposes of this paragraph (c)(2)(ii), a plan (or health insurance coverage) providing any benefits for a mental health condition or substance use disorder in any classification of benefits does not provide benefits for the mental health condition or substance use disorder in every classification in which medical/surgical benefits are provided unless the plan (or health insurance coverage) provides meaningful benefits for treatment for that condition or disorder in each such classification, as determined in comparison to the benefits provided for medical/surgical conditions in the classification. In determining the classification in which a particular benefit belongs, a plan (or health insurance issuer) must apply the same standards to medical/surgical benefits and to mental health or substance use disorder benefits. To the extent that a plan (or health insurance coverage) provides benefits in a classification and imposes any separate financial requirement or treatment limitation (or separate level of a financial requirement or treatment limitation) for benefits in the classification, the rules of this paragraph (c) apply separately with respect to that classification for all financial requirements or treatment limitations (illustrated in examples in paragraph (c)(2)(ii)(C) of this section). The following classifications of benefits are the only classifications used in applying the rules of this paragraph (c), in addition to the permissible sub-classifications described in paragraph (c)(3)(iii) of this section:

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(C) * * *

(1) Example 1—(i) Facts. A group health plan offers inpatient and outpatient benefits and does not contract with a network of providers. The plan imposes a $500 deductible on all benefits. For inpatient medical/surgical benefits, the plan imposes a coinsurance requirement. For outpatient medical/surgical benefits, the plan imposes copayments. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(1) (Example 1), because the plan has no network of providers, all benefits provided are out-of-network. Because inpatient, out-of-network medical/surgical benefits are subject to separate financial requirements from outpatient, out-of-network medical/surgical benefits, the rules of this paragraph (c) apply separately with respect to any financial requirements and treatment limitations, including the deductible, in each classification.

(2) Example 2—(i) Facts. A plan imposes a $500 deductible on all benefits. The plan has no network of providers. The plan generally imposes a 20 percent coinsurance requirement with respect to all benefits, without distinguishing among inpatient, outpatient, emergency care, or prescription drug benefits. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(2) (Example 2), because the plan does not impose separate financial requirements (or treatment limitations) based on classification, the rules of this paragraph (c) apply with respect to the deductible and the coinsurance across all benefits.

(3) Example 3—(i) Facts. Same facts as in paragraph (c)(2)(ii)(C)(2)(i) of this section (Example 2), except the plan exempts emergency care benefits from the 20 percent coinsurance requirement. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(3) (Example 3), because the plan imposes separate financial requirements based on classifications, the rules of this paragraph (c) apply with respect to the deductible and the coinsurance separately for benefits in the emergency care classification and all other benefits.

(4) Example 4—(i) Facts. Same facts as in paragraph (c)(2)(ii)(C)(2)(i) of this section (Example 2), except the plan also imposes a preauthorization requirement for all inpatient treatment in order for benefits to be paid. No such requirement applies to outpatient treatment.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(4) (Example 4), because the plan has no network of providers, all benefits provided are out-of-network. Because the plan imposes a separate treatment limitation based on classifications, the rules of this paragraph (c) apply with respect to the deductible and coinsurance separately for inpatient, out-of-network benefits and all other benefits.

(5) Example 5—(i) Facts. A plan 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 behavioral analysis (ABA) therapy, when provided on an out-of-network basis. The plan generally covers the full range of outpatient treatments and treatment settings for medical conditions and surgical procedures when provided on an out-of-network basis.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(5) (Example 5), the plan violates the rules of this paragraph (c)(2)(ii). Because the plan only covers one type of benefit for ASD in the outpatient, out-of-network classification and excludes all other benefits for ASD in the classification, but generally covers the full range of medical/surgical benefits in the classification, it fails to provide meaningful benefits for treatment of ASD in the classification.

(6) Example 6—(i) Facts. 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/surgical conditions in the outpatient, in-network classification.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(6) (Example 6), the plan violates the rules of this paragraph (c)(2)(ii). 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 medical/surgical conditions in the classification.

(3) * * *

(i) * * *

(A) Substantially all. For purposes of this paragraph (c)(3), a type of financial requirement or quantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification of benefits if it applies to at least two-thirds of all medical/surgical benefits in that classification. (For purposes of this paragraph (c)(3)(i)(A), benefits expressed as subject to a zero level of a type of financial requirement are treated as benefits not subject to that type of financial requirement, and benefits expressed as subject to a quantitative treatment limitation that is unlimited are treated as benefits not subject to that type of quantitative treatment limitation.) If a type of financial requirement or quantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, then that type cannot be applied to mental health or substance use disorder benefits in that classification.

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(C) Portion based on plan payments. For purposes of this paragraph (c)(3), the determination of the portion of medical/surgical benefits in a classification of benefits subject to a financial requirement or quantitative treatment limitation (or subject to any level of a financial requirement or quantitative treatment limitation) is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan for the plan year (or for the portion of the plan year after a change in plan benefits that affects the applicability of the financial requirement or quantitative treatment limitation).

(D) Clarifications for certain threshold requirements. For any deductible, the dollar amount of plan payments includes all plan payments with respect to claims that would be subject to the deductible if it had not been satisfied. For any out-of-pocket maximum, the dollar amount of plan payments includes all plan payments associated with out-of-pocket payments that are taken into account towards the out-of-pocket maximum as well as all plan payments associated with out-of-pocket payments that would have been made towards the out-of-pocket maximum if it had not been satisfied. Similar rules apply for any other thresholds at which the rate of plan payment changes. (See also PHS Act section 2707 and Affordable Care Act section 1302(c), which establish annual limitations on out-of-pocket maximums for all non-grandfathered health plans.)

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(iii) Special rules. Unless specifically permitted under this paragraph (c)(3)(iii), sub-classifications are not permitted when applying the rules of paragraph (c)(3) of this section.

(A) Multi-tiered prescription drug benefits. If a plan (or health insurance coverage) applies different levels of financial requirements to different tiers of prescription drug benefits based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section (relating to requirements for nonquantitative treatment limitations) and without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits, the plan (or health insurance coverage) satisfies the parity requirements of this paragraph (c) with respect to prescription drug benefits. Reasonable factors include cost, efficacy, generic versus brand name, and mail order versus pharmacy pick-up.

(B) Multiple network tiers. If a plan (or health insurance coverage) provides benefits through multiple tiers of in-network providers (such as an in-network tier of preferred providers with more generous cost-sharing to participants than a separate in-network tier of participating providers), the plan may divide its benefits furnished on an in-network basis into sub-classifications that reflect network tiers, if the tiering is based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section (such as quality, performance, and market standards) and without regard to whether a provider provides services with respect to medical/surgical benefits or mental health or substance use disorder benefits. After the sub-classifications are established, the plan or issuer may not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in any sub-classification that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in the sub-classification using the methodology set forth in paragraph (c)(3)(i) of this section.

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(iv) Examples. The rules of paragraphs (c)(3)(i) through (iii) of this section are illustrated by the following examples. In each example, the group health plan is subject to the requirements of this section and provides both medical/surgical benefits and mental health and substance use disorder benefits.

(A) Example 1—(1) Facts. (i) For inpatient, out-of-network medical/surgical benefits, a group health plan imposes five levels of coinsurance. Using a reasonable method, the plan projects its payments for the upcoming year as follows:

 

(ii) The plan projects plan costs of $800x to be subject to coinsurance ($100x + $450x + $100x + $150x = $800x). Thus, 80 percent ($800x/$1,000x) of the benefits are projected to be subject to coinsurance, and 56.25 percent of the benefits subject to coinsurance are projected to be subject to the 15 percent coinsurance level.

(2) Conclusion. In this paragraph (c)(3)(iv)(A) (Example 1), the two-thirds threshold of the substantially all standard is met for coinsurance because 80 percent of all inpatient, out-of-network medical/surgical benefits are subject to coinsurance. Moreover, the 15 percent coinsurance is the predominant level because it is applicable to more than one-half of inpatient, out-of-network medical/surgical benefits subject to the coinsurance requirement. The plan may not impose any level of coinsurance with respect to inpatient, out-of-network mental health or substance use disorder benefits that is more restrictive than the 15 percent level of coinsurance.

(B) Example 2—(1) Facts. (i) For outpatient, in-network medical/surgical benefits, a plan imposes five different copayment levels. Using a reasonable method, the plan projects payments for the upcoming year as follows:

 

(ii) The plan projects plan costs of $800x to be subject to copayments ($200x + $200x +$300x + $100x = $800x). Thus, 80 percent ($800x/$1,000x) of the benefits are projected to be subject to a copayment.

(2) Conclusion. In this paragraph (c)(3)(iv)(B) (Example 2), the two-thirds threshold of the substantially all standard is met for copayments because 80 percent of all outpatient, in-network medical/surgical benefits are subject to a copayment. Moreover, there is no single level that applies to more than one-half of medical/surgical benefits in the classification subject to a copayment (for the $10 copayment, 25%; for the $15 copayment, 25%; for the $20 copayment, 37.5%; and for the $50 copayment, 12.5%). The plan can combine any levels of copayment, including the highest levels, to determine the predominant level that can be applied to mental health or substance use disorder benefits. If the plan combines the highest levels of copayment, the combined projected payments for the two highest copayment levels, the $50 copayment and the $20 copayment, are not more than one-half of the outpatient, in-network medical/surgical benefits subject to a copayment because they are exactly one-half ($300x + $100x = $400x; $400x/$800x = 50%). The combined projected payments for the three highest copayment levels – the $50 copayment, the $20 copayment, and the $15 copayment – are more than one-half of the outpatient, in-network medical/surgical benefits subject to the copayments ($100x + $300x + $200x = $600x; $600x/$800x = 75%). Thus, the plan may not impose any copayment on outpatient, in-network mental health or substance use disorder benefits that is more restrictive than the least restrictive copayment in the combination, the $15 copayment.

(C) Example 3—(1) Facts. A plan imposes a $250 deductible on all medical/surgical benefits for self-only coverage and a $500 deductible on all medical/surgical benefits for family coverage. The plan has no network of providers. For all medical/surgical benefits, the plan imposes a coinsurance requirement. The plan imposes no other financial requirements or treatment limitations.

(2) Conclusion. In this paragraph (c)(3)(iv)(C) (Example 3), because the plan has no network of providers, all benefits are provided out-of-network. Because self-only and family coverage are subject to different deductibles, whether the deductible applies to substantially all medical/surgical benefits is determined separately for self-only medical/surgical benefits and family medical/surgical benefits. Because the coinsurance is applied without regard to coverage units, the predominant coinsurance that applies to substantially all medical/surgical benefits is determined without regard to coverage units.

(D) Example 4—(1) Facts. A plan applies the following financial requirements for prescription drug benefits. The requirements are applied without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits. Moreover, the process for certifying a particular drug as “generic”, “preferred brand name”, “non-preferred brand name”, or “specialty” complies with the rules of paragraph (c)(4) of this section (relating to requirements for nonquantitative treatment limitations).

 

(2) Conclusion. In this paragraph (c)(3)(iv)(D) (Example 4), the financial requirements that apply to prescription drug benefits are applied without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits; the process for certifying drugs in different tiers complies with paragraph (c)(4) of this section; and the bases for establishing different levels or types of financial requirements are reasonable. The financial requirements applied to prescription drug benefits do not violate the parity requirements of this paragraph (c)(3).

(E) Example 5—(1) Facts. A plan has two-tiers of network of providers: a preferred provider tier and a participating provider tier. Providers are placed in either the preferred tier or participating tier based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section, such as accreditation, quality and performance measures (including customer feedback), and relative reimbursement rates. Furthermore, provider tier placement is determined without regard to whether a provider specializes in the treatment of mental health conditions or substance use disorders, or medical/surgical conditions. The plan divides the in-network classifications into two sub-classifications (in-network/preferred and in-network/participating). The plan does not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in either of these sub-classifications that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in each sub-classification.

(2) Conclusion. In this paragraph (c)(3)(iv)(E) (Example 5), the division of in-network benefits into sub-classifications that reflect the preferred and participating provider tiers does not violate the parity requirements of this paragraph (c)(3).

(F) Example 6—(1) Facts. With respect to outpatient, in-network benefits, a plan imposes a $25 copayment for office visits and a 20 percent coinsurance requirement for outpatient surgery. The plan divides the outpatient, in-network classification into two sub-classifications (in-network office visits and all other outpatient, in-network items and services).The plan or issuer does not impose any financial requirement or quantitative treatment limitation on mental health or substance use disorder benefits in either of these sub-classifications that is more restrictive than the predominant financial requirement or quantitative treatment limitation that applies to substantially all medical/surgical benefits in each sub-classification.

(2) Conclusion. In this paragraph (c)(3)(iv)(F) (Example 6), the division of outpatient, in-network benefits into sub-classifications for office visits and all other outpatient, in-network items and services does not violate the parity requirements of this paragraph (c)(3).

(G) Example 7—(1) Facts. Same facts as in paragraph (c)(3)(iv)(F)(1) of this section (Example 6), but for purposes of determining parity, the plan divides the outpatient, in-network classification into outpatient, in-network generalists and outpatient, in-network specialists.

(2) Conclusion. In this paragraph (c)(3)(iv)(G) (Example 7), the division of outpatient, in-network benefits into any sub-classifications other than office visits and all other outpatient items and services violates the requirements of paragraph (c)(3)(iii)(C) of this section.

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(4) Nonquantitative treatment limitations. Subject to paragraph (c)(4)(v) of this section, a group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) may not impose a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in a classification unless the plan’s or coverage’s imposition of the limitation meets the requirements of paragraphs (c)(4)(i), (ii), and (iv) of this section. If a group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) fails to meet any of these requirements with respect to a nonquantitative treatment limitation, the limitation violates section 712(a)(3)(A)(ii) of ERISA and may not be imposed by the plan (or health insurance coverage).

(i) Requirement that nonquantitative treatment limitations be no more restrictive for mental health benefits and substance use disorder benefits. A group health plan (or health insurance issuer offering coverage in connection with a group health plan) may not apply any nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification that is more restrictive, as written or in operation, than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the same classification.

(A) Restrictive. For purposes of this paragraph (c)(4)(i), a nonquantitative treatment limitation is restrictive to the extent it imposes conditions, terms, or requirements that limit access to benefits under the terms of the plan or coverage. Conditions, terms, or requirements include, but are not limited to, those that compel an action by or on behalf of a participant or beneficiary to access benefits or limit access to the full range of treatment options available for a condition or disorder under the plan or coverage.

(B) Substantially all. For purposes of this paragraph (c)(4)(i), a nonquantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification if it applies to at least two-thirds of all medical/surgical benefits in that classification, consistent with paragraph (c)(4)(i)(D) of this section. Whether the nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits is determined without regard to whether the nonquantitative treatment limitation was triggered based on a particular factor or evidentiary standard. If a nonquantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, then that limitation cannot be applied to mental health or substance use disorder benefits in that classification.

(C) Predominant. For purposes of this paragraph (c)(4)(i), the term predominant means the most common or most frequent variation of the nonquantitative treatment limitation within a classification, determined in accordance with the method outlined in paragraph (c)(4)(i)(D) of this section, to the extent the plan or issuer imposes multiple variations of a nonquantitative treatment limitation within the classification. For example, multiple variations of inpatient concurrent review include review commencing 1 day, 3 days, or 7 days after admission, depending on the reason for the stay.

(D) Portion based on plan payments. For purposes of paragraphs (c)(4)(i)(B) and (C) of this section, the determination of the portion of medical/surgical benefits in a classification of benefits subject to a nonquantitative treatment limitation is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan or coverage for the plan year (or the portion of the plan year after a change in benefits that affects the applicability of the nonquantitative treatment limitation). Any reasonable method may be used to determine the dollar amount expected to be paid under a plan or coverage for medical/surgical benefits.

(E) Exceptions for independent professional medical or clinical standards and standards to detect or prevent and prove fraud, waste, and abuse. Notwithstanding paragraphs (c)(4)(i)(A) through (D) of this section, a plan or issuer that applies a nonquantitative treatment limitation that impartially applies independent professional medical or clinical standards or applies standards to detect or prevent and prove fraud, waste, and abuse, as described in paragraph (c)(4)(v)(A) or (B) of this section, to mental health or substance use disorder benefits in any classification will not be considered to violate this paragraph (c)(4)(i) with respect to such nonquantitative treatment limitation.

(ii) Additional requirements related to design and application of the nonquantitative treatment limitation—(A) In general. Consistent with paragraph (a)(1) of this section, a plan or issuer may not impose a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification unless, under the terms of the plan (or health insurance coverage) as written and in operation, any processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the classification 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 in the classification.

(B) Prohibition on discriminatory factors and evidentiary standards. For purposes of determining comparability and stringency under paragraph (c)(4)(ii)(A) of this section, a plan or issuer may not rely upon any factor or evidentiary standard if the information, evidence, sources, or standards on which the factor or evidentiary standard is based discriminates against mental health or substance use disorder benefits as compared to medical/surgical benefits. For purposes of this paragraph (c)(4)(ii)(B):

(1) Impartially applied generally recognized independent professional medical or clinical standards described in paragraph (c)(4)(v)(A) of this section are not considered to discriminate against mental health or substance use disorder benefits.

(2) Standards reasonably designed to detect or prevent and prove fraud, waste, and abuse described in paragraph (c)(4)(v)(B) of this section are not considered to discriminate against mental health or substance use disorder benefits.

(3) Information is considered to discriminate against mental health or substance use disorder benefits if it is biased or not objective, in a manner that results in less favorable treatment of mental health or substance use disorder benefits, based on all the relevant facts and circumstances including, but not limited to, the source of the information, the purpose or context of the information, and the content of the information.

(iii) Illustrative, non-exhaustive list of nonquantitative treatment limitations. Nonquantitative treatment limitations include –

(A) Medical management standards (such as prior authorization) limiting or excluding benefits based on medical necessity or medical appropriateness, or based on whether the treatment is experimental or investigative;

(B) Formulary design for prescription drugs;

(C) For plans with multiple network tiers (such as preferred providers and participating providers), network tier design;

(D) Standards related to network composition, including but 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;

(E) Plan 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;

(F) Refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is not effective (also known as fail-first policies or step therapy protocols);

(G) Exclusions based on failure to complete a course of treatment; and

(H) Restrictions based on geographic location, facility type, provider specialty, and other criteria that limit the scope or duration of benefits for services provided under the plan or coverage.

(iv) Required use of outcomes data—(A) In general. When designing and applying a nonquantitative treatment limitation, a plan or issuer must collect and evaluate relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation on access to mental health and substance use disorder benefits and medical/surgical benefits, and consider the impact as part of the plan’s or issuer’s analysis of whether the limitation, in operation, complies with paragraphs (c)(4)(i) and (ii) of this section. The Secretary, jointly with the Secretary of the Treasury and the Secretary of Health and Human Services, may specify in guidance the type, form, and manner of collection and evaluation for the data required under this paragraph (c)(4)(iv)(A).

(1) For purposes of this paragraph (c)(4)(iv)(A), relevant data includes, but is not limited to, the number and percentage of claims denials and any other data relevant to the nonquantitative treatment limitation required by State law or private accreditation standards.

(2) In addition to the relevant data set forth in paragraph (c)(4)(iv)(A)(1) of this section, relevant data for nonquantitative treatment limitations related to network composition standards includes, but is 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, and data on providers accepting new patients), and provider reimbursement rates (including as compared to billed charges).

(B) Material differences. Subject to paragraph (c)(4)(iv)(C) of this section, to the extent the relevant data evaluated pursuant to paragraph (c)(4)(iv)(A) of this section show material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, the differences will be considered a strong indicator that the plan or issuer violates paragraph (c)(4)(i) or (ii) of this section. In such instances, the plan or issuer:

(1) Must take reasonable action to address the material differences in access as necessary to ensure compliance, in operation, with paragraphs (c)(4)(i) and (ii) of this section; and

(2) Must document the action that has been or is being taken by the plan or issuer to mitigate any material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, as required by § 2590.712-1(c)(5)(iv).

(C) Special rule for nonquantitative treatment limitations related to network composition. Notwithstanding paragraph (c)(4)(iv)(B) of this section, when designing and applying one or more nonquantitative treatment limitation(s) related to network composition standards, a plan or issuer fails to meet the requirements of paragraphs (c)(4)(i) and (ii) of this section, in operation, if the relevant data show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in a classification.

(D) Exception for independent professional medical or clinical standards. A plan or issuer designing and applying a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification that impartially applies independent professional medical or clinical standards, as described in paragraph (c)(4)(v)(A) of this section, is not required to comply with the requirements of this paragraph (c)(4)(iv) with respect to that classification.

(v) Independent professional medical or clinical standards and standards to detect or prevent and prove fraud, waste, and abuse. (A) To qualify for the exceptions in paragraphs (c)(4)(i)(E), (c)(4)(ii)(B), and (c)(4)(iv)(D) of this section for independent professional medical or clinical standards, a nonquantitative treatment limitation must impartially apply generally recognized independent professional medical or clinical standards (consistent with generally accepted standards of care) to medical/surgical benefits and mental health or substance use disorder benefits, and may not deviate from those standards in any way, such as by imposing additional or different requirements.

(B) To qualify for the exceptions in paragraphs (c)(4)(i)(E) and (c)(4)(ii)(B) of this section to detect or prevent and prove fraud, waste, and abuse, a nonquantitative treatment limitation must be reasonably designed to detect or prevent and prove fraud, waste, and abuse, based on indicia of fraud, waste, and abuse that have been reliably established through objective and unbiased data, and also be narrowly designed to minimize the negative impact on access to appropriate mental health and substance use disorder benefits.

(vi) Prohibition on separate nonquantitative treatment limitations applicable only to mental health or substance use disorder benefits. Consistent with paragraph (c)(2)(i) of this section, a group health plan (or health insurance coverage offered by an issuer in connection with such a plan) may not apply any nonquantitative treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and does not apply with respect to any medical/surgical benefits in the same benefit classification.

(vii) Effect of final determination of noncompliance under § 2590.712-1. If a group health plan (or health insurance issuer offering group health insurance coverage in connection with such a plan) receives a final determination from the Secretary that the plan or issuer is not in compliance with the requirements of § 2590.712-1 with respect to a nonquantitative treatment limitation, the nonquantitative treatment limitation violates this paragraph (c)(4) and the Secretary may direct the plan or issuer not to impose the nonquantitative treatment limitation, unless and until the plan or issuer demonstrates to the Secretary compliance with the requirements of this section or takes appropriate action to remedy the violation.

(viii) Examples. The rules of this paragraph (c)(4) are illustrated by the following examples. In each example, the group health plan is subject to the requirements of this section and provides both medical/surgical benefits and mental health and substance use disorder benefits. Additionally, in examples that conclude that the plan or issuer violates one provision of this paragraph (c)(4), such examples do not necessarily imply compliance with other provisions of this paragraph (c)(4), as these examples do not analyze compliance with all other provisions of this paragraph (c)(4).

(A) Example 1 (More restrictive prior authorization requirement in operation)—(1) Facts. A plan requires prior authorization from the plan’s utilization reviewer that a treatment is medically necessary for all inpatient, in-network medical/surgical benefits and for all inpatient, in-network mental health and substance use disorder benefits. While inpatient, in-network benefits for medical/surgical conditions are approved for periods of 1, 3, and 7 days, after which a treatment plan must be submitted by the patient’s attending provider and approved by the plan, the approvals for 7 days are most common under this plan. For inpatient, in-network mental health and substance use disorder benefits, routine approval is most commonly given only for one day, after which a treatment plan must be submitted by the patient’s attending provider and approved by the plan. The difference in the duration of approvals is not the result of independent professional medical or clinical standards or standards to detect or prevent and prove fraud, waste, and abuse, but rather reflects the application of a heightened standard to the provision of the mental health and substance use disorder benefits in the relevant classification.

(2) Conclusion. In this paragraph (c)(4)(viii)(A) (Example 1), the plan violates the rules of paragraph (c)(4)(i) of this section. Under the terms of the plan, prior authorization applies to at least two-thirds of all medical/surgical benefits in the relevant classification (inpatient, in-network), since it applies to all benefits in the relevant classification. Further, the most common or frequent variation of the nonquantitative treatment limitation applied to medical/surgical benefits in the relevant classification (the predominant nonquantitative treatment limitation) is the routine approval of inpatient, in-network benefits for 7 days before the patient’s attending provider must submit a treatment plan. However, the plan routinely approves inpatient, in-network benefits for mental health and substance use disorder conditions for only 1 day before the patient’s attending provider must submit a treatment plan (and, in doing so, does not impartially apply independent professional medical or clinical standards or apply standards to detect or prevent and prove fraud, waste, and abuse that qualify for the exceptions in paragraph (c)(4)(i)(E) of this section). In operation, therefore, the prior authorization requirement imposed on inpatient, in-network mental health and substance use disorder benefits is more restrictive than the predominant prior authorization requirement applicable to substantially all medical/surgical benefits in the inpatient, in-network classification because the practice of approving only 1 day of inpatient benefits limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to the routine 7-day approval that is given for inpatient, in-network medical/surgical benefits. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(B) Example 2 (More restrictive peer-to-peer concurrent review requirements in operation)—(1) Facts. A plan follows a written process for the concurrent review of all medical/surgical benefits and mental health and substance use disorder benefits within the inpatient, in-network classification. Under the process, a first-level review is conducted in every instance in which concurrent review applies and an authorization request is approved by the first-level reviewer only if the clinical information submitted by the facility meets the plan’s criteria for a continued stay. If the first-level reviewer is unable to approve the authorization request because the clinical information submitted by the facility does not meet the plan’s criteria for a continued stay, it is sent to a second-level reviewer who will either approve or deny the request. While the written process only requires review by the second-level reviewer to either deny or approve the request, in operation, second-level reviewers for mental health and substance use disorder benefits conduct a peer-to-peer review with a provider (acting as the authorized representative of a participant or beneficiary) before coverage of the treatment is approved. The peer-to-peer review requirement is not the result of independent professional medical or clinical standards or standards to detect or prevent and prove fraud, waste, and abuse. The plan does not impose a peer-to-peer review, as written or in operation, as part of the second-level review for medical/surgical benefits.

(2) Conclusion. In this paragraph (c)(4)(viii)(B) (Example 2), the plan violates the rules of paragraph (c)(4)(i) of this section. The concurrent review nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits within the inpatient, in-network classification because the plan follows the concurrent review process for all medical/surgical benefits. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is that peer-to-peer review is not imposed as part of second-level review. The plan does not impartially apply independent professional medical or clinical standards or apply standards to detect or prevent and prove fraud, waste, and abuse that qualify for the exceptions in paragraph (c)(4)(i)(E) of this section. As written, the plan’s concurrent review requirements are the same for medical/surgical benefits and mental health and substance use disorder benefits. However, in operation, by compelling an additional action (peer-to-peer review as part of second-level review) to access only mental health or substance use disorder benefits, the plan applies the limitation to mental health and substance use disorder benefits in a manner that is more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the inpatient, in-network classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(C) Example 3 (More restrictive peer-to-peer review medical necessity standard in operation; deviation from independent professional medical and clinical standards)—(1) Facts. A plan generally requires that all treatment be medically necessary in the inpatient, out-of-network classification. For both medical/surgical benefits and mental health and substance use disorder benefits, the written medical necessity standards are based on independent professional medical or clinical standards that do not require peer-to-peer review. In operation, the plan covers out-of-network benefits for medical/surgical or mental health inpatient treatment outside of a hospital if the physician documents medical appropriateness, but for out-of-network benefits for substance use disorder inpatient treatment outside of a hospital, the plan requires a physician to also complete peer-to-peer review.

(2) Conclusion. In this paragraph (c)(4)(viii)(C) (Example 3), the plan violates the rules of paragraph (c)(4)(i) of this section. The medical necessity nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits in the inpatient, out-of-network classification. The most common or frequent variation of the nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is the requirement that a physician document medical appropriateness without peer-to-peer review. The plan purports to impartially apply independent professional medical or clinical standards that would otherwise qualify for the exception in paragraph (c)(4)(i)(E) of this section, but deviates from those standards by imposing the additional requirement to complete peer-to-peer review for inpatient, out-of-network benefits for substance use disorder outside of a hospital. Therefore, the exception in paragraph (c)(4)(i)(E) of this section does not apply. As written, the plan provisions apply the nonquantitative treatment limitation to mental health and substance use disorder benefits in the inpatient, out-of-network classification in the same manner as for medical/surgical benefits. However, in operation, the nonquantitative treatment limitation imposed with respect to out-of-network substance use disorder benefits for treatment outside of a hospital is more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the classification because it limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(D) Example 4 (Not comparable and more stringent methods for determining reimbursement rates in operation)—(1) Facts. A plan’s base reimbursement rates for outpatient, in-network providers are determined based on a variety of factors, including the providers’ required training, licensure, and expertise. For purposes of this example, the plan’s nonquantitative treatment limitations for determining reimbursement rates for mental health and substance use disorder benefits are not more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the classification under paragraph (c)(4)(i) of this section. As written, for mental health, substance use disorder, and medical/surgical benefits, all reimbursement rates for physicians and non-physician practitioners for the same Current Procedural Terminology (CPT) code vary based on a combination of factors, such as the nature of the service, provider type, number of providers qualified to provide the service in a given geographic area, and market need (demand). As a result, reimbursement rates for mental health, substance use disorder, and medical/surgical benefits furnished by non-physician providers are generally less than for physician providers. In operation, the plan reduces the reimbursement rate for mental health and substance use disorder non-physician providers from that paid to mental health and substance use disorder physicians by the same percentage for every CPT code but does not apply the same reductions for non-physician medical/surgical providers.

(2) Conclusion. In this paragraph (c)(4)(viii)(D) (Example 4), the plan violates the rules of paragraph (c)(4)(ii) of this section. Because the plan reimburses non-physician providers of mental health and substance use disorder services by reducing their reimbursement rate from the rate to physician providers by the same percentage for every CPT code but does not apply the same reductions to non-physician providers of medical/surgical services, in operation, the factors used in applying the nonquantitative treatment limitation to mental health and substance use disorder benefits are not comparable to, and are applied more stringently than, the factors used in applying the limitation with respect to medical/surgical benefits. Because the facts assume that the plan’s methods for determining reimbursement rates comply with paragraph (c)(4)(i) of this section and the plan violates the rules of paragraph (c)(4)(ii) of this section, this example does not analyze compliance with paragraph (c)(4)(iv) of this section.

(E) Example 5 (Exception for impartially applied generally recognized independent professional medical or clinical standards)—(1) Facts. A group health plan develops a medical management requirement for all inpatient, out-of-network benefits for both medical/surgical benefits and mental health and substance use disorder benefits to ensure treatment is medically necessary. The medical management requirement impartially applies independent professional medical or clinical standards in a manner that qualifies for the exception in paragraph (c)(4)(i)(E) of this section. The plan does not rely on any other factors or evidentiary standards and the processes, strategies, evidentiary standards, and other factors used in designing and applying the medical management requirement to mental health and substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in designing and applying the requirement with respect to medical/surgical benefits. Within the inpatient, out-of-network classification, the application of the medical management requirement results in a higher percentage of denials for mental health and substance use disorder claims than medical/surgical claims, because the benefits were found to be medically necessary for a lower percentage of mental health and substance use disorder claims based on the impartial application of the independent professional medical or clinical standards by the nonquantitative treatment limitation.

(2) Conclusion. In this paragraph (c)(4)(viii)(E) (Example 5), the plan does not violate the rules of this paragraph (c)(4). The medical management nonquantitative treatment limitation imposed on mental health and substance use disorder benefits does not violate paragraph (c)(4)(i) or (iv) of this section because it impartially applies independent professional medical or clinical standards for both medical/surgical benefits and mental health and substance use disorder benefits in a manner that qualifies for the exceptions in paragraphs (c)(4)(i)(E) and (c)(4)(iv)(D) of this section, respectively. Moreover, the nonquantitative treatment limitation does not violate paragraph (c)(4)(ii) of this section because the independent professional medical or clinical standards are not considered to be a discriminatory factor or evidentiary standard under paragraph (c)(4)(ii)(B) of this section. Additionally, as written and in operation, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the inpatient, out-of-network classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in applying the limitation with respect to medical/surgical benefits in the classification, regardless of the fact that the application of the nonquantitative treatment limitation resulted in higher percentages of claim denials for mental health and substance use disorder benefits as compared to medical/surgical benefits.

(F) Example 6 (More restrictive prior authorization requirement; exception for impartially applied generally recognized independent professional medical or clinical standards not met)—(1) Facts. The provisions of a plan state that it applies independent professional medical and clinical standards (consistent with generally accepted standards of care) for setting prior authorization requirements for both medical/surgical and mental health and substance use disorder prescription drugs. The relevant generally recognized independent professional medical standard for treatment of opioid use disorder that the plan utilizes—in this case, the American Society of Addiction Medicine national practice guidelines—does not support prior authorization every 30 days for buprenorphine/naloxone. However, in operation, the plan requires prior authorization for buprenorphine/naloxone combination at each refill (every 30 days) for treatment of opioid use disorder.

(2) Conclusion. In this paragraph (c)(4)(viii)(F) (Example 6), the plan violates the rules of paragraph (c)(4)(i) of this section. The plan does not qualify for the exception in paragraph (c)(4)(i)(E) of this section, because, although the provisions of the plan state that it applies independent professional medical and clinical standards, the plan deviates from the relevant standards with respect to prescription drugs to treat opioid use disorder. The prior authorization nonquantitative treatment limitation is applied to at least two-thirds of all medical/surgical benefits in the prescription drugs classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is following generally recognized independent professional medical and clinical standards (consistent with generally accepted standards of care). The prior authorization requirements imposed on substance use disorder benefits are more restrictive than the predominant nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in the classification, because the plan imposes additional requirements on substance use disorder benefits that limit access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(G) Example 7 (Impermissible nonquantitative treatment limitation imposed following a final determination of noncompliance and direction by the Secretary)—(1) Facts. Following an initial request by the Secretary for a plan’s comparative analysis of a nonquantitative treatment limitation pursuant to § 2590.712-1(d), the plan submits a comparative analysis for the nonquantitative treatment limitation. After review of the comparative analysis, the Secretary makes an initial determination that the comparative analysis fails to demonstrate that the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the relevant classification are comparable to, and applied no more stringently than, those used in designing and applying the limitation to medical/surgical benefits in the classification. Pursuant to § 2590.712-1(d)(3), the plan submits a corrective action plan and additional comparative analyses within 45 calendar days after the initial determination, and the Secretary then determines that the additional comparative analyses do not demonstrate compliance with the requirements of this paragraph (c)(4). The plan receives a final determination of noncompliance from the Secretary, which informs the plan that it is not in compliance with this paragraph (c)(4) and directs the plan not to impose the nonquantitative treatment limitation by a certain date, unless and until the plan demonstrates compliance to the Secretary or takes appropriate action to remedy the violation. The plan makes no changes to its plan terms by that date and continues to impose the nonquantitative treatment limitation.

(2) Conclusion. In this paragraph (c)(4)(viii)(G) (Example 7), the plan violates the requirements of this paragraph (c)(4) by imposing the nonquantitative treatment limitation after the Secretary directs the plan not to impose it, pursuant to paragraph (c)(4)(vii) of this section.

(H) Example 8 (Provider network admission standards not more restrictive and compliant with requirements for design and application of NQTLs)—(1) Facts. As part of a plan’s standards for provider admission to its network, in the outpatient, in-network classification, any provider seeking to contract with the plan must have a certain number of years of supervised clinical experience. As a result of that standard, master’s level mental health therapists are required to obtain supervised clinical experience beyond their licensure, while master’s level medical/surgical providers, psychiatrists, and Ph.D.-level psychologists do not require additional experience beyond their licensure because their licensure already requires supervised clinical experience. The plan collects and evaluates relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation. This includes in-network and out-of-network utilization rates (including data related to provider claim submissions), network adequacy metrics (including time and distance data, and data on providers accepting new patients), and provider reimbursement rates (including as compared to billed charges). This data demonstrates that participants and beneficiaries seeking outpatient care are able to access outpatient, in-network mental health and substance use disorder providers at the same frequency as outpatient, in-network medical/surgical providers, that mental health and substance use disorder providers are active in the network and are accepting new patients to the same extent as medical/surgical providers, and that mental health and substance use disorder providers are within similar time and distances to plan participants and beneficiaries as are medical/surgical providers. This data also does not identify material differences in what the plan or issuer pays psychiatrists or non-physician mental health providers, compared to physicians or non-physician medical/surgical providers, respectively, both for the same reimbursement codes and as compared to Medicare rates.

(2) Conclusion. In this paragraph (c)(4)(viii)(H) (Example 8), the plan does not violate this paragraph (c)(4). The standards for this nonquantitative treatment limitation, namely provider admission to the plan’s network, are applied to at least two-thirds of all medical/surgical benefits in the outpatient, in-network classification, as it applies to all medical/surgical benefits in the classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) that applies to substantially all medical/surgical benefits in the classification is having a certain number of years of supervised clinical experience. The standards for provider admission to the plan’s network that are imposed with respect to mental health or substance use disorder benefits are no more restrictive, as written or in operation, than the predominant variation of the nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in the classification, because the standards do not limit access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. The requirement that providers have a certain number of years of supervised clinical experience that the plan relied upon to design and apply the nonquantitative treatment limitation is not considered to discriminate against mental health or substance use disorder benefits, even though this results in the requirement that master’s level mental health therapists obtain supervised clinical experience beyond their licensure, unlike master’s level medical/surgical providers. In addition, as written and in operation, the processes, strategies, evidentiary standards, or other factors used in applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying the limitation with respect to medical/surgical benefits in the classification, because the plan applies the same standard to all providers in the classification. Finally, the plan or issuer collects and evaluates relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation on access to mental health and substance use disorder benefits, which does not show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in the classification.

(I) Example 9 (More restrictive requirement for primary caregiver participation applied to ABA therapy)—(1) Facts. A plan generally applies medical necessity criteria in adjudicating claims for coverage of all outpatient, in-network medical/surgical and mental health and substance use disorder benefits, including ABA therapy for the treatment of ASD, which is a mental health condition. The plan’s medical necessity criteria for coverage of ABA therapy requires evidence that the participant’s or beneficiary’s primary caregivers actively participate in ABA therapy, as documented by consistent attendance in parent, caregiver, or guardian training sessions. In adding this requirement, the plan deviates from independent professional medical or clinical standards, and there are no similar medical necessity criteria requiring evidence of primary caregiver participation in order to receive coverage of any medical/surgical benefits.

(2) Conclusion. In this paragraph (c)(4)(viii)(I) (Example 9), the plan violates paragraph (c)(4)(i) of this section. The plan applies medical necessity criteria to at least two-thirds of all outpatient, in-network medical/surgical benefits, as they apply to all medical/surgical benefits in the classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) that applies to substantially all medical/surgical benefits in the classification does not include the requirement to provide evidence that the participant’s or beneficiary’s primary caregivers actively participate in the treatment. The plan does not qualify for the exception in paragraph (c)(4)(i)(E) of this section in applying its restriction on coverage for ABA therapy because the plan deviates from the independent professional medical or clinical standards by imposing a different requirement. As a result, the nonquantitative treatment limitation imposed on mental health and substance use disorder benefits is more restrictive than the predominant medical necessity requirement imposed on substantially all medical/surgical benefits in the classification (which does not include the requirement to provide evidence that primary caregivers actively participate in treatment). Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(J) Example 10 (More restrictive exclusion for experimental or investigative treatment applied to ABA therapy)—(1) Facts. A plan, as written, generally excludes coverage for all treatments that are experimental or investigative for both medical/surgical benefits and mental health and substance use disorder benefits in the outpatient, in-network classification. As a result, the plan generally excludes experimental treatment of medical conditions and surgical procedures, mental health conditions, and substance use disorders when no professionally recognized treatment guidelines define clinically appropriate standards of care for the condition or disorder and fewer than two randomized controlled trials are available to support the treatment’s use with respect to the given condition or disorder. The plan provides benefits for the treatment of ASD, which is a mental health condition, but, in operation, the plan excludes coverage for ABA therapy to treat children with ASD, deeming it experimental. More than one professionally recognized treatment guideline defines clinically appropriate standards of care for ASD and more than two randomized controlled trials are available to support the use of ABA therapy to treat certain children with ASD.

(2) Conclusion. In this paragraph (c)(4)(viii)(J) (Example 10), the plan violates the rules of paragraph (c)(4)(i) of this section. The coverage exclusion for experimental or investigative treatment applies to at least two-thirds of all medical/surgical benefits, as it applies to all medical/surgical benefits in the outpatient, in-network classification. The most common or frequent variation of this nonquantitative treatment limitation in the classification (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is the exclusion under the plan for coverage of experimental treatment of medical/surgical conditions when no professionally recognized treatment guidelines define clinically appropriate standards of care for the condition or disorder and fewer than two randomized controlled trials are available to support the treatment’s use with respect to the given condition or procedure. In operation, the exclusion for experimental or investigative treatment imposed on ABA therapy is more restrictive than the predominant variation of the nonquantitative treatment limitation for experimental or investigative treatment imposed on substantially all medical/surgical benefits in the classification because the exclusion limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(K) Example 11 (Separate EAP exhaustion treatment limitation applicable only to mental health benefits)—(1) Facts. An employer maintains both a major medical plan and an employee assistance program (EAP). The EAP provides, among other benefits, a limited number of mental health or substance use disorder counseling sessions, which, together with other benefits provided by the EAP, are not significant benefits in the nature of medical care. Participants are eligible for mental health or substance use disorder benefits under the major medical plan only after exhausting the counseling sessions provided by the EAP. No similar exhaustion requirement applies with respect to medical/surgical benefits provided under the major medical plan.

(2) Conclusion. In this paragraph (c)(4)(viii)(K) (Example 11), limiting eligibility for mental health and substance use disorder benefits under the major medical plan until EAP benefits are exhausted is a nonquantitative treatment limitation subject to the parity requirements of this paragraph (c). Because the limitation does not apply to medical/surgical benefits, it is a separate nonquantitative treatment limitation applicable only to mental health and substance use disorder benefits that violates paragraph (c)(4)(vi) of this section. Additionally, this EAP would not qualify as excepted benefits under § 2590.732(c)(3)(vi)(B)(1) because participants in the major medical plan are required to use and exhaust benefits under the EAP (making the EAP a gatekeeper) before an individual is eligible for benefits under the plan.

(L) Example 12 (Separate residential exclusion treatment limitation applicable only to mental health benefits)—(1) Facts. A plan generally covers inpatient, in-network and inpatient out-of-network treatment in any setting, including skilled nursing facilities and rehabilitation hospitals, provided other medical necessity standards are satisfied. The plan also has an exclusion for residential treatment, which the plan defines as an inpatient benefit, for mental health and substance use disorder benefits. This exclusion was not generated through any broader nonquantitative treatment limitation (such as medical necessity or other clinical guideline).

(2) Conclusion. In this paragraph (c)(4)(viii)(L) (Example 12), the plan violates the rules of paragraph (c)(4)(vi) of this section. Because the plan does not apply a comparable exclusion to inpatient benefits for medical/surgical conditions, the exclusion of residential treatment is a separate nonquantitative treatment limitation applicable only to mental health and substance use disorder benefits in the inpatient, in-network and inpatient, out-of-network classifications that does not apply with respect to any medical/surgical benefits in the same benefit classification.

(M) Example 13 (Standards for provider admission to a network)—(1) Facts. A plan applies nonquantitative treatment limitations related to network composition in the outpatient in-network and inpatient, in-network classifications. The plan’s networks are constructed by separate service providers for medical/surgical benefits and mental health and substance use disorder benefits. For purposes of this example, these facts assume that these nonquantitative treatment limitations related to network composition for mental health and substance use disorder benefits are not more restrictive than the predominant nonquantitative treatment limitations applied to substantially all medical/surgical benefits in the classifications under paragraph (c)(4)(i) of this section. The facts also assume that, as written and in operation, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitations related to network access to mental health or substance use disorder benefits in the outpatient in-network and inpatient in-network classifications are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitations with respect to medical/surgical benefits in the classifications, as required under paragraph (c)(4)(ii) of this section. The plan collects and evaluates all relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitations related to network composition on access to mental health and substance use disorder benefits as compared with access to medical/surgical benefits and considers the impact as part of the plan’s or issuer’s analysis of whether the standards, in operation, comply with paragraphs (c)(4)(i) and (ii) of this section. The plan determined that the data did not reveal any material differences in access. That data included metrics relating to the time and distance from plan participants and beneficiaries to network providers in rural and urban regions; the number of network providers accepting new patients; the proportions of mental health and substance use disorder and medical/surgical providers and facilities that provide services in rural and urban regions who are in the plan’s network; provider reimbursement rates; in-network and out-of-network utilization rates (including data related to the dollar value and number of provider claims submissions); and survey data from participants on the extent to which they forgo or pay out-of-pocket for treatment because of challenges finding in-network providers. The efforts the plan made when designing and applying its nonquantitative treatment limitations related to network composition, which ultimately led to its outcomes data not revealing any material differences in access to benefits for mental health or substance use disorders as compared with medical/surgical benefits, included making sure that the plan’s service providers are making special efforts to enroll available providers, including by authorizing greater compensation or other inducements to the extent necessary, and expanding telehealth arrangements as appropriate to manage regional shortages. The plan also notifies participants in clear and prominent language on its website, employee brochures, and the summary plan description of a toll-free number available to help participants find in-network providers. In addition, when plan participants submit bills for out-of-network items and services, the plan directs their service providers to reach out to the treating providers and facilities to see if they will enroll in the network.

(2) Conclusion. In this paragraph (c)(4)(viii)(M) (Example 13), the plan does not violate this paragraph (c)(4). As stated in the Facts section, the plan’s nonquantitative treatment limitations related to network composition comply with the rules of paragraphs (c)(4)(i) and (ii) of this section. The plan collects and evaluates relevant data, as required under paragraph (c)(4)(iv)(A) of this section, and the data does not reveal any material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, as a result of the actions the plan took (as set forth in the facts) when initially designing its nonquantitative treatment limitations related to network composition. Because the plan takes comparable actions to ensure that their mental health and substance use disorder provider network is as accessible as their medical/surgical provider network and exercises careful oversight over both their service providers and the comparative robustness of the networks with an eye to ensuring that network composition results in access to in-network benefits for mental health and substance use disorder services that is as generous as for medical/surgical services, plan participants and beneficiaries can access covered mental health and substance use disorder services and benefits as readily as medical/surgical benefits. This is reflected in the plan’s carefully designed metrics and assessment of network composition.

* * * * *

(d) * * *

(3) Provisions of other law. Compliance with the disclosure requirements in paragraphs (d)(1) and (2) of this section is not determinative of compliance with any other provision of applicable Federal or State law. In particular, in addition to those disclosure requirements, provisions of other applicable law require disclosure of information relevant to medical/surgical, mental health, and substance use disorder benefits. For example, ERISA section 104 and § 2520.104b-1 of this chapter provide that, for plans subject to ERISA, instruments under which the plan is established or operated must generally be furnished to plan participants within 30 days of request. Instruments under which the plan is established or operated include documents with information on medical necessity criteria for both medical/surgical benefits and mental health and substance use disorder benefits; the processes, strategies, evidentiary standards, and other factors used to apply a nonquantitative treatment limitation with respect to medical/surgical benefits and mental health or substance use disorder benefits under the plan; and the comparative analyses and other applicable information required by § 2590.712-1. In addition, § 2560.503-1 of this chapter and § 2590.715-2719 set forth rules regarding claims and appeals, including the right of claimants (or their authorized representative) upon appeal of an adverse benefit determination (or a final internal adverse benefit determination) to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the claimant’s claim for benefits. This includes documents with information on medical necessity criteria for both medical/surgical benefits and mental health and substance use disorder benefits, as well as the processes, strategies, evidentiary standards, and other factors used to apply a nonquantitative treatment limitation with respect to medical/surgical benefits and mental health or substance use disorder benefits under the plan and the comparative analyses and other applicable information required by § 2590.712-1.

(e) * * *

(4) Coordination with EHB requirements. Nothing in paragraph (f) or (g) of this section or § 2590.712-1(g) changes the requirements of 45 CFR 147.150 and 156.115, providing that a health insurance issuer offering non-grandfathered health insurance coverage in the individual or small group market providing mental health and substance use disorder services, including behavioral health treatment services, as part of essential health benefits required under 45 CFR 156.110(a)(5) and 156.115(a), must comply with the requirements under section 2726 of the Public Health Service Act and its implementing regulations to satisfy the requirement to provide coverage for mental health and substance use disorder services, including behavioral health treatment, as part of essential health benefits.

* * * * *

(i) * * *

(1) In general. Except as provided in paragraph (i)(2) of this section, this section applies to group health plans and health insurance issuers offering group health insurance coverage on the first day of the first plan year beginning on or after January 1, 2025. Until the applicability date in the preceding sentence, plans and issuers are required to continue to comply with 29 CFR 2590.712, revised as of July 1, 2022.

* * * * *

(j) Severability. If any provision of this section is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, the provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

6. Add § 2590.712-1 to read as follows:

(a) Meaning of terms. Unless otherwise stated in this section, the terms of this section have the meanings indicated in § 2590.712(a)(2).

(b) In general. In the case of a group health plan (or health insurance issuer offering group health insurance coverage in connection with a group health plan) that provides both medical/surgical benefits and mental health or substance use disorder benefits and that imposes any nonquantitative treatment limitation on mental health or substance use disorder benefits, the plan or issuer must perform and document a comparative analysis of the design and application of each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits. Each comparative analysis must comply with the content requirements of paragraph (c) of this section and be made available to the Secretary, upon request, in the manner required by paragraphs (d) and (e) of this section.

(c) Comparative analysis content requirements. With respect to each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits under a group health plan (or health insurance coverage offered in connection with a group health plan), the comparative analysis performed by the plan or issuer must include, at minimum, the elements specified in this paragraph (c). In addition to the comparative analysis for each nonquantitative treatment limitation, each plan or issuer must prepare and make available to the Secretary, upon request, a written list of all nonquantitative treatment limitations imposed under the plan or coverage and a general description of any information considered or relied upon by the plan or issuer in preparing the comparative analysis for each nonquantitative treatment limitation. This list and general description must be provided to the named fiduciaries of the plan who are required to review the findings or conclusions of each comparative analysis, as required under paragraph (c)(6)(vi) of this section.

(1) Description of the nonquantitative treatment limitation. The comparative analysis must include, with respect to the nonquantitative treatment limitation that is the subject of the comparative analysis:

(i) Identification of the nonquantitative treatment limitation, including the specific terms of the plan or coverage or other relevant terms regarding the nonquantitative treatment limitation, the policies or guidelines (internal or external) in which the nonquantitative treatment limitation appears or is described, and the applicable sections of any other relevant documents, such as provider contracts, that describe the nonquantitative treatment limitation;

(ii) Identification of all mental health or substance use disorder benefits and medical/surgical benefits to which the nonquantitative treatment limitation applies, including a list of which benefits are considered mental health or substance use disorder benefits and which benefits are considered medical/surgical benefits;

(iii) A description of which benefits are included in each classification set forth in § 2590.712(c)(2)(ii)(A); and

(iv) Identification of the predominant nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in each classification, including an explanation of how the plan or issuer determined which variation is the predominant nonquantitative treatment limitation as compared to other variations, as well as how the plan identified the variations of the nonquantitative treatment limitation.

(2) Identification and definition of the factors used to design or apply the nonquantitative treatment limitation. The comparative analysis must include, with respect to every factor considered or relied upon to design the nonquantitative treatment limitation or apply the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits:

(i) Identification of all of the factors considered, as well as the evidentiary standards considered or relied upon to design or apply each factor and the sources from which each evidentiary standard was derived, in determining which mental health or substance use disorder benefits and which medical/surgical benefits are subject to the nonquantitative treatment limitation; and

(ii) A definition of each factor, including:

(A) A detailed description of the factor; and

(B) A description of each evidentiary standard (and the source of each evidentiary standard) identified under paragraph (c)(2)(i) of this section.

(3) Description of how factors are used in the design and application of the nonquantitative treatment limitation. The comparative analysis must include a description of how each factor identified and defined pursuant to paragraph (c)(2) of this section is used in the design or application of the nonquantitative treatment limitation to mental health and substance use disorder benefits and medical/surgical benefits in a classification, including:

(i) A detailed explanation of how each factor identified and defined in paragraph (c)(2) of this section is used to determine which mental health or substance use disorder benefits and which medical/surgical benefits are subject to the nonquantitative treatment limitation;

(ii) An explanation of the evidentiary standards or other information or sources (if any) considered or relied upon in designing or applying the factors or relied upon in designing and applying the nonquantitative treatment limitation, including in the determination of whether and how mental health or substance use disorder benefits or medical/surgical benefits are subject to the nonquantitative treatment limitation;

(iii) If the application of the factor depends on specific decisions made in the administration of benefits, the nature of the decisions, the timing of the decisions, and the professional designation and qualifications of each decision maker;

(iv) If more than one factor is identified and defined in paragraph (c)(2) of this section, an explanation of:

(A) How all of the factors relate to each other;

(B) The order in which all the factors are applied, including when they are applied;

(C) Whether and how any factors are given more weight than others; and

(D) The reasons for the ordering or weighting of the factors; and

(v) Any deviation(s) or variation(s) from a factor, its applicability, or its definition (including the evidentiary standards used to define the factor and the information or sources from which each evidentiary standard was derived), such as how the factor is used differently to apply the nonquantitative treatment limitation to mental health or substance use disorder benefits as compared to medical/surgical benefits, and a description of how the plan or issuer establishes such deviation(s) or variation(s).

(4) Demonstration of comparability and stringency as written. The comparative analysis must evaluate whether, in any classification, under the terms of the plan (or health insurance coverage) as written, any processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder 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 nonquantitative treatment limitation with respect to medical/surgical benefits. The comparative analysis must include, with respect to the nonquantitative treatment limitation and the factors used in designing and applying the nonquantitative treatment limitation:

(i) Documentation of each factor identified and defined in paragraph (c)(2) of this section that was applied to determine whether the nonquantitative treatment limitation applies to mental health or substance use disorder benefits and medical/surgical benefits in a classification, including, as relevant:

(A) Quantitative data, calculations, or other analyses showing whether, in each classification in which the nonquantitative treatment limitation applies, mental health or substance use disorder benefits and medical/surgical benefits met or did not meet any applicable threshold identified in the relevant evidentiary standard, and the evaluation of relevant data as required under § 2590.712(c)(4)(iv)(A), to determine that the nonquantitative treatment limitation would or would not apply; and

(B) Records maintained by the plan or issuer documenting the consideration and application of all factors and evidentiary standards, as well as the results of their application;

(ii) In each classification in which the nonquantitative treatment limitation applies to mental health or substance use disorder benefits, a comparison of how the nonquantitative treatment limitation, as written, is applied to mental health or substance use disorder benefits and to medical/surgical benefits, including the specific provisions of any forms, checklists, procedure manuals, or other documentation used in designing and applying the nonquantitative treatment limitation or that address the application of the nonquantitative treatment limitation;

(iii) Documentation demonstrating how the factors are comparably applied, as written, to mental health or substance use disorder benefits and medical/surgical benefits in each classification, to determine which benefits are subject to the nonquantitative treatment limitation; and

(iv) An explanation of the reason(s) for any deviation(s) or variation(s) in the application of a factor used to apply the nonquantitative treatment limitation, or the application of the nonquantitative treatment limitation, to mental health or substance use disorder benefits as compared to medical/surgical benefits, and how the plan or issuer establishes such deviation(s) or variation(s), including:

(A) In the definition of the factors, the evidentiary standards used to define the factors, and the sources from which the evidentiary standards were derived;

(B) In the design of the factors or evidentiary standards; or

(C) In the application or design of the nonquantitative treatment limitation.

(5) Demonstration of comparability and stringency in operation. The comparative analysis must evaluate whether, in any classification, under the terms of the plan (or health insurance coverage) in operation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder 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. The comparative analysis must include, with respect to the nonquantitative treatment limitation and the factors used in designing and applying the nonquantitative treatment limitation:

(i) A comprehensive explanation of how the plan or issuer ensures that, in operation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in a classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation with respect to medical/surgical benefits, including:

(A) An explanation of any methodology and underlying data used to demonstrate the application of the nonquantitative treatment limitation, in operation; and

(B) The sample period, inputs used in any calculations, definitions of terms used, and any criteria used to select the mental health or substance use disorder benefits and medical/surgical benefits to which the nonquantitative treatment limitation is applicable;

(ii) Identification of the relevant data collected and evaluated as required under § 2590.712(c)(4)(iv)(A);

(iii) An evaluation of the outcomes that resulted from the application of the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits, including the relevant data as required under § 2590.712(c)(4)(iv)(A);

(iv) A detailed explanation of material differences in outcomes evaluated pursuant to paragraph (c)(5)(iii) of this section that are not attributable to differences in the comparability or relative stringency of the nonquantitative treatment limitation as applied to mental health or substance use disorder benefits and medical/surgical benefits and the bases for concluding that material differences in outcomes are not attributable to differences in the comparability or relative stringency of the nonquantitative treatment limitation; and

(v) A discussion of any measures that have been or are being implemented by the plan or issuer to mitigate any material differences in access to mental health or substance use disorder benefits as compared to medical/surgical benefits, including the actions the plan or issuer is taking under § 2590.712(c)(4)(iv)(B)(1) to address material differences to ensure compliance with § 2590.712(c)(4)(i) and (ii).

(6) Findings and conclusions. The comparative analysis must address the findings and conclusions as to the comparability of the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits within each classification, and the relative stringency of their application, both as written and in operation, and include:

(i) Any findings or conclusions indicating that the plan or coverage is not (or might not be) in compliance with the requirements of § 2590.712(c)(4), including any actions the plan or issuer has taken or intends to take to address any potential areas of concern or noncompliance;

(ii) A reasoned and detailed discussion of the findings and conclusions described in paragraph (c)(6)(i) of this section;

(iii) Citations to any additional specific information not otherwise included in the comparative analysis that supports the findings and conclusions described in paragraph (c)(6)(i) of this section;

(iv) The date of the analysis and the title and credentials of all relevant persons who participated in the performance and documentation of the comparative analysis;

(v) If the comparative analysis relies upon an evaluation by a reviewer or consultant considered by the plan or issuer to be an expert, an assessment of each expert’s qualifications and the extent to which the plan or issuer ultimately relied upon each expert’s evaluation in performing and documenting the comparative analysis of the design and application of each nonquantitative treatment limitation applicable to both mental health or substance use disorder benefits and medical/surgical benefits; and

(vi) A certification by one or more named fiduciaries who have reviewed the comparative analysis stating whether they found the comparative analysis to be in compliance with the content requirements of paragraph (c) of this section.

(d) Requirements related to submission of comparative analyses to the Secretary upon request—(1) Initial request by the Secretary for comparative analysis. A group health plan or health insurance issuer offering group health insurance coverage must make the comparative analysis required by paragraph (b) of this section available and submit it to the Secretary within 10 business days of receipt of a request from the Secretary (or an additional period of time specified by the Secretary).

(2) Additional information required after a comparative analysis is deemed to be insufficient. In instances in which the Secretary determines that the plan or issuer has not submitted sufficient information under paragraph (d)(1) of this section for the Secretary to review the comparative analysis required in paragraph (b) of this section, the Secretary will specify to the plan or issuer the additional information the plan or issuer must submit to the Secretary to be responsive to the request under paragraph (d)(1) of this section. Any such information must be provided to the Secretary by the plan or issuer within 10 business days after the Secretary specifies the additional information to be submitted (or an additional period of time specified by the Secretary).

(3) Initial determination of noncompliance, required action, and corrective action plan. In instances in which the Secretary reviewed the comparative analysis submitted under paragraph (d)(1) of this section and any additional information submitted under paragraph (d)(2) of this section, and made an initial determination that the plan or issuer is not in compliance with the requirements of § 2590.712(c)(4) or this section, the plan or issuer must respond to the Secretary and specify the actions the plan or issuer will take to bring the plan or coverage into compliance, and provide to the Secretary additional comparative analyses meeting the requirements of paragraph (b) of this section that demonstrate compliance with § 2590.712(c)(4) and this section, not later than 45 calendar days after the Secretary’s initial determination that the plan or issuer is not in compliance.

(4) Requirement to notify participants and beneficiaries of final determination of noncompliance—(i) In general. If the Secretary makes a final determination of noncompliance, the plan or issuer must notify all participants and beneficiaries enrolled in the plan or coverage that the plan or issuer has been determined to not be in compliance with the requirements of § 2590.712(c)(4) or this section with respect to such plan or coverage. Such notice must be provided within 7 calendar days of receipt of the final determination of noncompliance, and the plan or issuer must provide a copy of the notice to the Secretary, and any service provider involved in the claims process, and any fiduciary responsible for deciding benefit claims within the same time frame.

(ii) Content of notice. The notice to participants and beneficiaries required in paragraph (d)(4)(i) of this section shall be written in a manner calculated to be understood by the average plan participant and must include, in plain language, the following information in a standalone notice:

(A) The following statement prominently displayed on the first page, in no less than 14-point font: “Attention! The Department of Labor 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.”;

(B) A summary of changes the plan or issuer has made as part of its corrective action plan specified to the Secretary following the initial determination of noncompliance, including an explanation of any opportunity for a participant or beneficiary to have a claim for benefits reprocessed;

(C) A summary of the Secretary’s final determination that the plan or issuer is not in compliance with § 2590.712(c)(4) or this section, including any provisions or practices identified as being in violation of MHPAEA, additional corrective actions identified by the Secretary in the final determination notice, and information on how participants and beneficiaries can obtain from the plan or issuer a copy of the final determination of noncompliance;

(D) Any additional actions the plan or issuer is taking to come into compliance with § 2590.712(c)(4) or this section, when the plan or issuer will take such actions, and a clear and accurate statement explaining whether the Secretary has indicated that those actions, if completed, will result in compliance; and

(E) Contact information for questions and complaints, and a statement explaining how participants and beneficiaries can obtain more information about the notice, including:

(1) The plan’s or issuer’s phone number and an email or web portal address; and

(2) The Employee Benefits Security Administration’s phone number and email or web portal address.

(iii) Manner of notice. The plan or issuer must make the notice required under paragraph (d)(4)(i) of this section available in paper form, or electronically (such as by email or an Internet posting) if:

(A) The format is readily accessible;

(B) The notice is provided in paper form free of charge upon request; and

(C) In a case in which the electronic form is an internet posting, the plan or issuer timely notifies the participant or beneficiary in paper form (such as a postcard) or email, that the documents are available on the internet, provides the internet address, includes the statement required in paragraph (d)(4)(ii)(A) of this section, and notifies the participant or beneficiary that the documents are available in paper form upon request.

(e) Requests for a copy of a comparative analysis. In addition to making a comparative analysis available upon request to the Secretary, a plan or issuer must make available a copy of the comparative analysis required by paragraph (b) of this section when requested by:

(1) Any applicable State authority;

(2) A participant or beneficiary (or a provider or other person acting as a participant’s or beneficiary’s authorized representative) who has received an adverse benefit determination related to mental health or substance use disorder benefits; and

(3) Participants and beneficiaries, who may request the comparative analysis at any time under ERISA section 104.

(f) Rule of construction. Nothing in this section or § 2590.712 shall be construed to prevent the Secretary from acting within the scope of existing authorities to address violations of § 2590.712 or this section.

(g) Applicability. The provisions of this section apply to group health plans and health insurance issuers offering group health insurance coverage described in § 2590.712(e), to the extent the plan or issuer is not exempt under § 2590.712(f) or (g), for plan years beginning on or after January 1, 2025.

(h) Severability. If any provision of this section is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, the provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

7. The authority citation for part 146 continues to read as follows:

Authority: 42 U.S.C. 300gg–1 through 300gg–5, 300gg–11 through 300gg–23, 300gg–91, and 300gg–92.

8. Amend § 146.136 is amended by:

a. Redesignating paragraph (a) as paragraph (a)(2) and adding paragraphs (a) heading and (a)(1);

b. In newly redesignated paragraph (a)(2):

i. Revising the introductory text;

ii. Adding the definitions of “DSM,” “Evidentiary standards,” “Factors,” and “ICD” in alphabetical order;

iii. Revising the definitions of “Medical/surgical benefits” and “Mental health benefits”;

iv. Adding the definitions of “Processes” and “Strategies” in alphabetical order; and

v. Revising the definitions of “Substance use disorder benefits” and “Treatment limitations”;

c. Revising paragraphs (c)(1)(ii), (c)(2)(i), and (c)(2)(ii)(A) introductory text;

d. In paragraph (c)(2)(ii)(C), designating Examples 1 through 4 as paragraphs (c)(2)(ii)(C)(1) through (4) and revising newly designated paragraphs (c)(2)(ii)(C)(1) through (4);

e. Adding paragraphs (c)(2)(ii)(C)(5) and (6);

f. Revising paragraphs (c)(3)(i)(A), (C), and (D);

g. In paragraph (c)(3)(iii), adding introductory text;

h. Revising paragraphs (c)(3)(iii)(A) and (B), (c)(3)(iv), (c)(4), (d)(3), (e)(4), and (i)(1); and

i. Adding paragraph (j).

The revisions and additions read as follows:

(a) Purpose and meaning of terms – (1) Purpose. This section and § 146.137 set forth rules to ensure parity in aggregate lifetime and annual dollar limits, financial requirements, and quantitative and nonquantitative treatment limitations between mental health and substance use disorder benefits and medical/surgical benefits, as required under PHS Act section 2726. A fundamental purpose of PHS Act section 2726, this section, and § 146.137 is to ensure that participants and beneficiaries in a group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) that offers mental health or substance use disorder benefits are not subject to more restrictive lifetime or annual dollar limits, financial requirements, or treatment limitations with respect to those benefits than the predominant dollar limits, financial requirements, or treatment limitations that are applied to substantially all medical/surgical benefits covered by the plan or coverage, as further provided in this section and § 146.137. Accordingly, in complying with the provisions of PHS Act section 2726, this section, and § 146.137, plans and issuers must not design or apply financial requirements and treatment limitations that impose a greater burden on access (that is, are more restrictive) to mental health and substance use disorder benefits under the plan or coverage than they impose on access to generally comparable medical/surgical benefits. The provisions of PHS section 2726, this section, and § 146.137 should be interpreted in a manner that is consistent with the purpose described in this paragraph (a)(1).

(2) Meaning of terms. For purposes of this section and § 146.137, except where the context clearly indicates otherwise, the following terms have the meanings indicated:

* * * * *

DSM means the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders. For the purpose of this definition, the most current version of the DSM is the version that is applicable no earlier than on the date that is 1 year before the first day of the applicable plan year.

Evidentiary standards are any evidence, sources, or standards that a group health plan (or health insurance issuer offering coverage in connection with such a plan) considered or relied upon in designing or applying a factor with respect to a nonquantitative treatment limitation, including specific benchmarks or thresholds. Evidentiary standards may be empirical, statistical, or clinical in nature, and include: sources acquired or originating from an objective third party, such as recognized medical literature, professional standards and protocols (which may include comparative effectiveness studies and clinical trials), published research studies, payment rates for items and services (such as publicly available databases of the “usual, customary and reasonable” rates paid for items and services), and clinical treatment guidelines; internal plan or issuer data, such as claims or utilization data or criteria for assuring a sufficient mix and number of network providers; and benchmarks or thresholds, such as measures of excessive utilization, cost levels, time or distance standards, or network participation percentage thresholds.

Factors are all information, including processes and strategies (but not evidentiary standards), that a group health plan (or health insurance issuer offering coverage in connection with such a plan) considered or relied upon to design a nonquantitative treatment limitation, or to determine whether or how the nonquantitative treatment limitation applies to benefits under the plan or coverage. Examples of factors include, but are not limited to: provider discretion in determining a diagnosis or type or length of treatment; clinical efficacy of any proposed treatment or service; licensing and accreditation of providers; claim types with a high percentage of fraud; quality measures; treatment outcomes; severity or chronicity of condition; variability in the cost of an episode of treatment; high cost growth; variability in cost and quality; elasticity of demand; and geographic location.

* * * * *

ICD means the World Health Organization’s International Classification of Diseases adopted by the Department of Health and Human Services through § 162.1002 of this subtitle. For the purpose of this definition, the most current version of the ICD is the version that is applicable no earlier than on the date that is 1 year before the first day of the applicable plan year.

Medical/surgical benefits means benefits with respect to items or services for medical conditions or surgical procedures, as defined under the terms of the group health plan (or health insurance coverage offered by an issuer in connection with such a plan) and in accordance with applicable Federal and State law, but does not include mental health benefits or substance use disorder benefits. Notwithstanding the preceding sentence, any condition or procedure defined by the plan or coverage as being or as not being a medical condition or surgical procedure must be defined consistent with generally recognized independent standards of current medical practice (for example, the most current version of the ICD). To the extent generally recognized independent standards of current medical practice do not address whether a condition or procedure is a medical condition or surgical procedure, plans and issuers may define the condition or procedure in accordance with applicable Federal and State law.

Mental health benefits means benefits with respect to items or services for mental health conditions, as defined under the terms of the group health plan (or health insurance coverage offered by an issuer in connection with such a plan) and in accordance with applicable Federal and State law, but does not include medical/surgical benefits or substance use disorder benefits. Notwithstanding the preceding sentence, any condition defined by the plan or coverage as being or as not being a mental health condition must be defined consistent with generally recognized independent standards of current medical practice. For the purpose of this definition, to be consistent with generally recognized independent standards of current medical practice, the definition must include all conditions covered under the plan or coverage, except for substance use disorders, that fall under any of the diagnostic categories listed in the mental, behavioral, and neurodevelopmental disorders chapter (or equivalent chapter) of the most current version of the ICD or that are listed in the most current version of the DSM. To the extent generally recognized independent standards of current medical practice do not address whether a condition is a mental health condition, plans and issuers may define the condition in accordance with applicable Federal and State law.

Processes are actions, steps, or procedures that a group health plan (or health insurance issuer offering coverage in connection with such a plan) uses to apply a nonquantitative treatment limitation, including actions, steps, or procedures established by the plan or issuer as requirements in order for a participant or beneficiary to access benefits, including through actions by a participant’s or beneficiary’s authorized representative or a provider or facility. Processes include but are not limited to: procedures to submit information to authorize coverage for an item or service prior to receiving the benefit or while treatment is ongoing (including requirements for peer or expert clinical review of that information); provider referral requirements; and the development and approval of a treatment plan. Processes also include the specific procedures used by staff or other representatives of a plan or issuer (or the service provider of a plan or issuer) to administer the application of nonquantitative treatment limitations, such as how a panel of staff members applies the nonquantitative treatment limitation (including the qualifications of staff involved, number of staff members allocated, and time allocated), consultations with panels of experts in applying the nonquantitative treatment limitation, and reviewer discretion in adhering to criteria hierarchy when applying a nonquantitative treatment limitation.

Strategies are practices, methods, or internal metrics that a plan (or health insurance issuer offering coverage in connection with such a plan) considers, reviews, or uses to design a nonquantitative treatment limitation. Examples of strategies include but are not limited to: the development of the clinical rationale used in approving or denying benefits; deviation from generally accepted standards of care; the selection of information deemed reasonably necessary to make a medical necessity determination; reliance on treatment guidelines or guidelines provided by third-party organizations; and rationales used in selecting and adopting certain threshold amounts, professional protocols, and fee schedules. Strategies also include the creation and composition of the staff or other representatives of a plan or issuer (or the service provider of a plan or issuer) that deliberates, or otherwise makes decisions, on the design of nonquantitative treatment limitations, including the plan’s decisions related to the qualifications of staff involved, number of staff members allocated, and time allocated; breadth of sources and evidence considered; consultations with panels of experts in designing the nonquantitative treatment limitation; and the composition of the panels used to design a nonquantitative treatment limitation.

Substance use disorder benefits means benefits with respect to items or services for substance use disorders, as defined under the terms of the group health plan (or health insurance coverage offered by an issuer in connection with such a plan) and in accordance with applicable Federal and State law, but does not include medical/surgical benefits or mental health benefits. Notwithstanding the preceding sentence, any disorder defined by the plan or coverage as being or as not being a substance use disorder must be defined consistent with generally recognized independent standards of current medical practice. For the purpose of this definition, to be consistent with generally recognized independent standards of current medical practice, the definition must include all disorders covered under the plan or coverage that fall under any of the diagnostic categories listed as a mental or behavioral disorder due to psychoactive substance use (or equivalent category) in the mental, behavioral and neurodevelopmental disorders chapter (or equivalent chapter) of the most current version of the ICD or that are listed as a Substance-Related and Addictive Disorder (or equivalent category) in the most current version of the DSM. To the extent generally recognized independent standards of current medical practice do not address whether a disorder is a substance use disorder, plans and issuers may define the disorder in accordance with applicable Federal and State law.

Treatment limitations include limits on benefits based on the frequency of treatment, number of visits, days of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. Treatment limitations include both quantitative treatment limitations, which are expressed numerically (such as 50 outpatient visits per year), and nonquantitative treatment limitations, which otherwise limit the scope or duration of benefits for treatment under a plan or coverage. (See paragraph (c)(4)(iii) of this section for an illustrative, non-exhaustive list of nonquantitative treatment limitations.) A complete exclusion of all benefits for a particular condition or disorder, however, is not a treatment limitation for purposes of this definition.

* * * * *

(c) * * *

(1) * * *

(ii) Type of financial requirement or treatment limitation. When reference is made in this paragraph (c) to a type of financial requirement or treatment limitation, the reference to type means its nature. Different types of financial requirements include deductibles, copayments, coinsurance, and out-of-pocket maximums. Different types of quantitative treatment limitations include annual, episode, and lifetime day and visit limits. See paragraph (c)(4)(iii) of this section for an illustrative, non-exhaustive list of nonquantitative treatment limitations.

* * * * *

(2) * * *

(i) General rule. A group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) that provides both medical/surgical benefits and mental health or substance use disorder benefits may not apply any financial requirement or treatment limitation to mental health or substance use disorder benefits in any classification that is more restrictive than the predominant financial requirement or treatment limitation of that type applied to substantially all medical/surgical benefits in the same classification. Whether a financial requirement or treatment limitation is a predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in a classification is determined separately for each type of financial requirement or treatment limitation. A plan or issuer may not impose any financial requirement or treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and not to any medical/surgical benefits in the same benefit classification. The application of the rules of this paragraph (c)(2) to financial requirements and quantitative treatment limitations is addressed in paragraph (c)(3) of this section; the application of the rules of this paragraph (c)(2) to nonquantitative treatment limitations is addressed in paragraph (c)(4) of this section.

(ii) * * *

(A) In general. If a plan (or health insurance coverage) provides any benefits for a mental health condition or substance use disorder in any classification of benefits described in this paragraph (c)(2)(ii), benefits for that mental health condition or substance use disorder must be provided in every classification in which medical/surgical benefits are provided. For purposes of this paragraph (c)(2)(ii), a plan (or health insurance coverage) providing any benefits for a mental health condition or substance use disorder in any classification of benefits does not provide benefits for the mental health condition or substance use disorder in every classification in which medical/surgical benefits are provided unless the plan (or health insurance coverage) provides meaningful benefits for treatment for that condition or disorder in each such classification, as determined in comparison to the benefits provided for medical/surgical conditions in the classification. In determining the classification in which a particular benefit belongs, a plan (or health insurance issuer) must apply the same standards to medical/surgical benefits and to mental health or substance use disorder benefits. To the extent that a plan (or health insurance coverage) provides benefits in a classification and imposes any separate financial requirement or treatment limitation (or separate level of a financial requirement or treatment limitation) for benefits in the classification, the rules of this paragraph (c) apply separately with respect to that classification for all financial requirements or treatment limitations (illustrated in examples in paragraph (c)(2)(ii)(C) of this section). The following classifications of benefits are the only classifications used in applying the rules of this paragraph (c), in addition to the permissible sub-classifications described in paragraph (c)(3)(iii) of this section:

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(C) * * *

(1) Example 1—(i) Facts. A group health plan offers inpatient and outpatient benefits and does not contract with a network of providers. The plan imposes a $500 deductible on all benefits. For inpatient medical/surgical benefits, the plan imposes a coinsurance requirement. For outpatient medical/surgical benefits, the plan imposes copayments. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(1) (Example 1), because the plan has no network of providers, all benefits provided are out-of-network. Because inpatient, out-of-network medical/surgical benefits are subject to separate financial requirements from outpatient, out-of-network medical/surgical benefits, the rules of this paragraph (c) apply separately with respect to any financial requirements and treatment limitations, including the deductible, in each classification.

(2) Example 2—(i) Facts. A plan imposes a $500 deductible on all benefits. The plan has no network of providers. The plan generally imposes a 20 percent coinsurance requirement with respect to all benefits, without distinguishing among inpatient, outpatient, emergency care, or prescription drug benefits. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(2) (Example 2), because the plan does not impose separate financial requirements (or treatment limitations) based on classification, the rules of this paragraph (c) apply with respect to the deductible and the coinsurance across all benefits.

(3) Example 3—(i) Facts. Same facts as in paragraph (c)(2)(ii)(C)(2)(i) of this section (Example 2), except the plan exempts emergency care benefits from the 20 percent coinsurance requirement. The plan imposes no other financial requirements or treatment limitations.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(3) (Example 3), because the plan imposes separate financial requirements based on classifications, the rules of this paragraph (c) apply with respect to the deductible and the coinsurance separately for benefits in the emergency care classification and all other benefits.

(4) Example 4—(i) Facts. Same facts as in paragraph (c)(2)(ii)(C)(2)(i) of this section (Example 2), except the plan also imposes a preauthorization requirement for all inpatient treatment in order for benefits to be paid. No such requirement applies to outpatient treatment.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(4) (Example 4), because the plan has no network of providers, all benefits provided are out-of-network. Because the plan imposes a separate treatment limitation based on classifications, the rules of this paragraph (c) apply with respect to the deductible and coinsurance separately for inpatient, out-of-network benefits and all other benefits.

(5) Example 5—(i) Facts. A plan 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 behavioral analysis (ABA) therapy, when provided on an out-of-network basis. The plan generally covers the full range of outpatient treatments and treatment settings for medical conditions and surgical procedures when provided on an out-of-network basis.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(5) (Example 5), the plan violates the rules of this paragraph (c)(2)(ii). Because the plan only covers one type of benefit for ASD in the outpatient, out-of-network classification and excludes all other benefits for ASD in the classification, but generally covers the full range of medical/surgical benefits in the classification, it fails to provide meaningful benefits for treatment of ASD in the classification.

(6) Example 6—(i) Facts. 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/surgical conditions in the outpatient, in-network classification.

(ii) Conclusion. In this paragraph (c)(2)(ii)(C)(6) (Example 6), the plan violates the rules of this paragraph (c)(2)(ii). 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 medical/surgical conditions in the classification.

(3) * * *

(i) * * *

(A) Substantially all. For purposes of this paragraph (c)(3), a type of financial requirement or quantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification of benefits if it applies to at least two-thirds of all medical/surgical benefits in that classification. (For purposes of this paragraph (c)(3)(i)(A), benefits expressed as subject to a zero level of a type of financial requirement are treated as benefits not subject to that type of financial requirement, and benefits expressed as subject to a quantitative treatment limitation that is unlimited are treated as benefits not subject to that type of quantitative treatment limitation.) If a type of financial requirement or quantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, then that type cannot be applied to mental health or substance use disorder benefits in that classification.

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(C) Portion based on plan payments. For purposes of this paragraph (c)(3), the determination of the portion of medical/surgical benefits in a classification of benefits subject to a financial requirement or quantitative treatment limitation (or subject to any level of a financial requirement or quantitative treatment limitation) is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan for the plan year (or for the portion of the plan year after a change in plan benefits that affects the applicability of the financial requirement or quantitative treatment limitation).

(D) Clarifications for certain threshold requirements. For any deductible, the dollar amount of plan payments includes all plan payments with respect to claims that would be subject to the deductible if it had not been satisfied. For any out-of-pocket maximum, the dollar amount of plan payments includes all plan payments associated with out-of-pocket payments that are taken into account towards the out-of-pocket maximum as well as all plan payments associated with out-of-pocket payments that would have been made towards the out-of-pocket maximum if it had not been satisfied. Similar rules apply for any other thresholds at which the rate of plan payment changes. (See also PHS Act section 2707 and Affordable Care Act section 1302(c), which establish annual limitations on out-of-pocket maximums for all non-grandfathered health plans.)

* * * * *

(iii) Special rules. Unless specifically permitted under this paragraph (c)(3)(iii), sub-classifications are not permitted when applying the rules of paragraph (c)(3) of this section.

(A) Multi-tiered prescription drug benefits. If a plan (or health insurance coverage) applies different levels of financial requirements to different tiers of prescription drug benefits based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section (relating to requirements for nonquantitative treatment limitations) and without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits, the plan (or health insurance coverage) satisfies the parity requirements of this paragraph (c) with respect to prescription drug benefits. Reasonable factors include cost, efficacy, generic versus brand name, and mail order versus pharmacy pick-up.

(B) Multiple network tiers. If a plan (or health insurance coverage) provides benefits through multiple tiers of in-network providers (such as an in-network tier of preferred providers with more generous cost-sharing to participants than a separate in-network tier of participating providers), the plan may divide its benefits furnished on an in-network basis into sub-classifications that reflect network tiers, if the tiering is based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section (such as quality, performance, and market standards) and without regard to whether a provider provides services with respect to medical/surgical benefits or mental health or substance use disorder benefits. After the sub-classifications are established, the plan or issuer may not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in any sub-classification that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in the sub-classification using the methodology set forth in paragraph (c)(3)(i) of this section.

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(iv) Examples. The rules of paragraphs (c)(3)(i) through (iii) of this section are illustrated by the following examples. In each example, the group health plan is subject to the requirements of this section and provides both medical/surgical benefits and mental health and substance use disorder benefits.

(A) Example 1—(1) Facts. (i) For inpatient, out-of-network medical/surgical benefits, a group health plan imposes five levels of coinsurance. Using a reasonable method, the plan projects its payments for the upcoming year as follows:

 

(ii) The plan projects plan costs of $800x to be subject to coinsurance ($100x + $450x + $100x + $150x = $800x). Thus, 80 percent ($800x/$1,000x) of the benefits are projected to be subject to coinsurance, and 56.25 percent of the benefits subject to coinsurance are projected to be subject to the 15 percent coinsurance level.

(2) Conclusion. In this paragraph (c)(3)(iv)(A) (Example 1), the two-thirds threshold of the substantially all standard is met for coinsurance because 80 percent of all inpatient, out-of-network medical/surgical benefits are subject to coinsurance. Moreover, the 15 percent coinsurance is the predominant level because it is applicable to more than one-half of inpatient, out-of-network medical/surgical benefits subject to the coinsurance requirement. The plan may not impose any level of coinsurance with respect to inpatient, out-of-network mental health or substance use disorder benefits that is more restrictive than the 15 percent level of coinsurance.

(B) Example 2—(1) Facts. (i) For outpatient, in-network medical/surgical benefits, a plan imposes five different copayment levels. Using a reasonable method, the plan projects payments for the upcoming year as follows:

 

(ii) The plan projects plan costs of $800x to be subject to copayments ($200x + $200x +$300x + $100x = $800x). Thus, 80 percent ($800x/$1,000x) of the benefits are projected to be subject to a copayment.

(2) Conclusion. In this paragraph (c)(3)(iv)(B) (Example 2), the two-thirds threshold of the substantially all standard is met for copayments because 80 percent of all outpatient, in-network medical/surgical benefits are subject to a copayment. Moreover, there is no single level that applies to more than one-half of medical/surgical benefits in the classification subject to a copayment (for the $10 copayment, 25%; for the $15 copayment, 25%; for the $20 copayment, 37.5%; and for the $50 copayment, 12.5%). The plan can combine any levels of copayment, including the highest levels, to determine the predominant level that can be applied to mental health or substance use disorder benefits. If the plan combines the highest levels of copayment, the combined projected payments for the two highest copayment levels, the $50 copayment and the $20 copayment, are not more than one-half of the outpatient, in-network medical/surgical benefits subject to a copayment because they are exactly one-half ($300x + $100x = $400x; $400x/$800x = 50%). The combined projected payments for the three highest copayment levels – the $50 copayment, the $20 copayment, and the $15 copayment – are more than one-half of the outpatient, in-network medical/surgical benefits subject to the copayments ($100x + $300x + $200x = $600x; $600x/$800x = 75%). Thus, the plan may not impose any copayment on outpatient, in-network mental health or substance use disorder benefits that is more restrictive than the least restrictive copayment in the combination, the $15 copayment.

(C) Example 3—(1) Facts. A plan imposes a $250 deductible on all medical/surgical benefits for self-only coverage and a $500 deductible on all medical/surgical benefits for family coverage. The plan has no network of providers. For all medical/surgical benefits, the plan imposes a coinsurance requirement. The plan imposes no other financial requirements or treatment limitations.

(2) Conclusion. In this paragraph (c)(3)(iv)(C) (Example 3), because the plan has no network of providers, all benefits are provided out-of-network. Because self-only and family coverage are subject to different deductibles, whether the deductible applies to substantially all medical/surgical benefits is determined separately for self-only medical/surgical benefits and family medical/surgical benefits. Because the coinsurance is applied without regard to coverage units, the predominant coinsurance that applies to substantially all medical/surgical benefits is determined without regard to coverage units.

(D) Example 4—(1) Facts. A plan applies the following financial requirements for prescription drug benefits. The requirements are applied without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits. Moreover, the process for certifying a particular drug as “generic”, “preferred brand name”, “non-preferred brand name”, or “specialty” complies with the rules of paragraph (c)(4) of this section (relating to requirements for nonquantitative treatment limitations).

 

(2) Conclusion. In this paragraph (c)(3)(iv)(D) (Example 4), the financial requirements that apply to prescription drug benefits are applied without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health or substance use disorder benefits; the process for certifying drugs in different tiers complies with paragraph (c)(4) of this section; and the bases for establishing different levels or types of financial requirements are reasonable. The financial requirements applied to prescription drug benefits do not violate the parity requirements of this paragraph (c)(3).

(E) Example 5—(1) Facts. A plan has two-tiers of network of providers: a preferred provider tier and a participating provider tier. Providers are placed in either the preferred tier or participating tier based on reasonable factors determined in accordance with the rules in paragraph (c)(4) of this section, such as accreditation, quality and performance measures (including customer feedback), and relative reimbursement rates. Furthermore, provider tier placement is determined without regard to whether a provider specializes in the treatment of mental health conditions or substance use disorders, or medical/surgical conditions. The plan divides the in-network classifications into two sub-classifications (in-network/preferred and in-network/participating). The plan does not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in either of these sub-classifications that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in each sub-classification.

(2) Conclusion. In this paragraph (c)(3)(iv)(E) (Example 5), the division of in-network benefits into sub-classifications that reflect the preferred and participating provider tiers does not violate the parity requirements of this paragraph (c)(3).

(F) Example 6—(1) Facts. With respect to outpatient, in-network benefits, a plan imposes a $25 copayment for office visits and a 20 percent coinsurance requirement for outpatient surgery. The plan divides the outpatient, in-network classification into two sub-classifications (in-network office visits and all other outpatient, in-network items and services). The plan or issuer does not impose any financial requirement or quantitative treatment limitation on mental health or substance use disorder benefits in either of these sub-classifications that is more restrictive than the predominant financial requirement or quantitative treatment limitation that applies to substantially all medical/surgical benefits in each sub-classification.

(2) Conclusion. In this paragraph (c)(3)(iv)(F) (Example 6), the division of outpatient, in-network benefits into sub-classifications for office visits and all other outpatient, in-network items and services does not violate the parity requirements of this paragraph (c)(3).

(G) Example 7—(1) Facts. Same facts as in paragraph (c)(3)(iv)(F)(1) of this section (Example 6), but for purposes of determining parity, the plan divides the outpatient, in-network classification into outpatient, in-network generalists and outpatient, in-network specialists.

(2) Conclusion. In this paragraph (c)(3)(iv)(G) (Example 7), the division of outpatient, in-network benefits into any sub-classifications other than office visits and all other outpatient items and services violates the requirements of paragraph (c)(3)(iii)(C) of this section.

* * * * *

(4) Nonquantitative treatment limitations. Subject to paragraph (c)(4)(v) of this section, a group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) may not impose a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in a classification unless the plan’s or coverage’s imposition of the limitation meets the requirements of paragraphs (c)(4)(i), (ii), and (iv) of this section. If a group health plan (or health insurance coverage offered by an issuer in connection with a group health plan) fails to meet any of these requirements with respect to a nonquantitative treatment limitation, the limitation violates section 2726(a)(3)(A)(ii) of the PHS Act and may not be imposed by the plan (or health insurance coverage).

(i) Requirement that nonquantitative treatment limitations be no more restrictive for mental health benefits and substance use disorder benefits. A group health plan (or health insurance issuer offering coverage in connection with a group health plan) may not apply any nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification that is more restrictive, as written or in operation, than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the same classification.

(A) Restrictive. For purposes of this paragraph (c)(4)(i), a nonquantitative treatment limitation is restrictive to the extent it imposes conditions, terms, or requirements that limit access to benefits under the terms of the plan or coverage. Conditions, terms, or requirements include, but are not limited to, those that compel an action by or on behalf of a participant or beneficiary to access benefits or limit access to the full range of treatment options available for a condition or disorder under the plan or coverage.

(B) Substantially all. For purposes of this paragraph (c)(4)(i), a nonquantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification if it applies to at least two-thirds of all medical/surgical benefits in that classification, consistent with paragraph (c)(4)(i)(D) of this section. Whether the nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits is determined without regard to whether the nonquantitative treatment limitation was triggered based on a particular factor or evidentiary standard. If a nonquantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, then that limitation cannot be applied to mental health or substance use disorder benefits in that classification.

(C) Predominant. For purposes of this paragraph (c)(4)(i), the term predominant means the most common or most frequent variation of the nonquantitative treatment limitation within a classification, determined in accordance with the method outlined in paragraph (c)(4)(i)(D) of this section, to the extent the plan or issuer imposes multiple variations of a nonquantitative treatment limitation within the classification. For example, multiple variations of inpatient concurrent review include review commencing 1 day, 3 days, or 7 days after admission, depending on the reason for the stay.

(D) Portion based on plan payments. For purposes of paragraphs (c)(4)(i)(B) and (C) of this section, the determination of the portion of medical/surgical benefits in a classification of benefits subject to a nonquantitative treatment limitation is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan or coverage for the plan year (or the portion of the plan year after a change in benefits that affects the applicability of the nonquantitative treatment limitation). Any reasonable method may be used to determine the dollar amount expected to be paid under a plan or coverage for medical/surgical benefits.

(E) Exceptions for independent professional medical or clinical standards and standards to detect or prevent and prove fraud, waste, and abuse. Notwithstanding paragraphs (c)(4)(i)(A) through (D) of this section, a plan or issuer that applies a nonquantitative treatment limitation that impartially applies independent professional medical or clinical standards or applies standards to detect or prevent and prove fraud, waste, and abuse, as described in paragraph (c)(4)(v)(A) or (B) of this section, to mental health or substance use disorder benefits in any classification will not be considered to violate this paragraph (c)(4)(i) with respect to such nonquantitative treatment limitation.

(ii) Additional requirements related to design and application of the nonquantitative treatment limitation—(A) In general. Consistent with paragraph (a)(1) of this section, a plan or issuer may not impose a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification unless, under the terms of the plan (or health insurance coverage) as written and in operation, any processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the classification 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 in the classification.

(B) Prohibition on discriminatory factors and evidentiary standards. For purposes of determining comparability and stringency under paragraph (c)(4)(ii)(A) of this section, a plan or issuer may not rely upon any factor or evidentiary standard if the information, evidence, sources, or standards on which the factor or evidentiary standard is based discriminates against mental health or substance use disorder benefits as compared to medical/surgical benefits. For purposes of this paragraph (c)(4)(ii)(B):

(1) Impartially applied generally recognized independent professional medical or clinical standards described in paragraph (c)(4)(v)(A) of this section are not considered to discriminate against mental health or substance use disorder benefits.

(2) Standards reasonably designed to detect or prevent and prove fraud, waste, and abuse described in paragraph (c)(4)(v)(B) of this section are not considered to discriminate against mental health or substance use disorder benefits.

(3) Information is considered to discriminate against mental health or substance use disorder benefits if it is biased or not objective, in a manner that results in less favorable treatment of mental health or substance use disorder benefits, based on all the relevant facts and circumstances including, but not limited to, the source of the information, the purpose or context of the information, and the content of the information.

(iii) Illustrative, non-exhaustive list of nonquantitative treatment limitations. Nonquantitative treatment limitations include –

(A) Medical management standards (such as prior authorization) limiting or excluding benefits based on medical necessity or medical appropriateness, or based on whether the treatment is experimental or investigative;

(B) Formulary design for prescription drugs;

(C) For plans with multiple network tiers (such as preferred providers and participating providers), network tier design;

(D) Standards related to network composition, including but 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;

(E) Plan 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;

(F) Refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is not effective (also known as fail-first policies or step therapy protocols);

(G) Exclusions based on failure to complete a course of treatment; and

(H) Restrictions based on geographic location, facility type, provider specialty, and other criteria that limit the scope or duration of benefits for services provided under the plan or coverage.

(iv) Required use of outcomes data—(A) In general. When designing and applying a nonquantitative treatment limitation, a plan or issuer must collect and evaluate relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation on access to mental health and substance use disorder benefits and medical/surgical benefits, and consider the impact as part of the plan’s or issuer’s analysis of whether the limitation, in operation, complies with paragraphs (c)(4)(i) and (ii) of this section. The Secretary, jointly with the Secretary of the Treasury and the Secretary of Labor, may specify in guidance the type, form, and manner of collection and evaluation for the data required under this paragraph (c)(4)(iv)(A).

(1) For purposes of this paragraph (c)(4)(iv)(A), relevant data includes, but is not limited to, the number and percentage of claims denials and any other data relevant to the nonquantitative treatment limitation required by State law or private accreditation standards.

(2) In addition to the relevant data set forth in paragraph (c)(4)(iv)(A)(1) of this section, relevant data for nonquantitative treatment limitations related to network composition standards includes, but is 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, and data on providers accepting new patients), and provider reimbursement rates (including as compared to billed charges).

(B) Material differences. Subject to paragraph (c)(4)(iv)(C) of this section, to the extent the relevant data evaluated pursuant to paragraph (c)(4)(iv)(A) of this section show material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, the differences will be considered a strong indicator that the plan or issuer violates paragraph (c)(4)(i) or (ii) of this section. In such instances, the plan or issuer:

(1) Must take reasonable action to address the material differences in access as necessary to ensure compliance, in operation, with paragraphs (c)(4)(i) and (ii) of this section; and

(2) Must document the action that has been or is being taken by the plan or issuer to mitigate any material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, as required by § 146.137(c)(5)(iv).

(C) Special rule for nonquantitative treatment limitations related to network composition. Notwithstanding paragraph (c)(4)(iv)(B) of this section, when designing and applying one or more nonquantitative treatment limitation(s) related to network composition standards, a plan or issuer fails to meet the requirements of paragraphs (c)(4)(i) and (ii) of this section, in operation, if the relevant data show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in a classification.

(D) Exception for independent professional medical or clinical standards. A plan or issuer designing and applying a nonquantitative treatment limitation with respect to mental health or substance use disorder benefits in any classification that impartially applies independent professional medical or clinical standards, as described in paragraph (c)(4)(v)(A) of this section, is not required to comply with the requirements of this paragraph (c)(4)(iv) with respect to that classification.

(v) Independent professional medical or clinical standards and standards to detect or prevent and prove fraud, waste, and abuse. (A) To qualify for the exceptions in paragraphs (c)(4)(i)(E), (c)(4)(ii)(B), and (c)(4)(iv)(D) of this section for independent professional medical or clinical standards, a nonquantitative treatment limitation must impartially apply generally recognized independent professional medical or clinical standards (consistent with generally accepted standards of care) to medical/surgical benefits and mental health or substance use disorder benefits, and may not deviate from those standards in any way, such as by imposing additional or different requirements.

(B) To qualify for the exceptions in paragraphs (c)(4)(i)(E) and (c)(4)(ii)(B) of this section to detect or prevent and prove fraud, waste, and abuse, a nonquantitative treatment limitation must be reasonably designed to detect or prevent and prove fraud, waste, and abuse, based on indicia of fraud, waste, and abuse that have been reliably established through objective and unbiased data, and also be narrowly designed to minimize the negative impact on access to appropriate mental health and substance use disorder benefits.

(vi) Prohibition on separate nonquantitative treatment limitations applicable only to mental health or substance use disorder benefits. Consistent with paragraph (c)(2)(i) of this section, a group health plan (or health insurance coverage offered by an issuer in connection with such a plan) may not apply any nonquantitative treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and does not apply with respect to any medical/surgical benefits in the same benefit classification.

(vii) Effect of final determination of noncompliance under § 146.137. If a group health plan (or health insurance issuer offering group health insurance coverage in connection with such a plan) receives a final determination from the Secretary that the plan or issuer is not in compliance with the requirements of § 146.137 with respect to a nonquantitative treatment limitation, the nonquantitative treatment limitation violates this paragraph (c)(4) and the Secretary may direct the plan or issuer not to impose the nonquantitative treatment limitation, unless and until the plan or issuer demonstrates to the Secretary compliance with the requirements of this section or takes appropriate action to remedy the violation.

(viii) Examples. The rules of this paragraph (c)(4) are illustrated by the following examples. In each example, the group health plan is subject to the requirements of this section and provides both medical/surgical benefits and mental health and substance use disorder benefits. Additionally, in examples that conclude that the plan or issuer violates one provision of this paragraph (c)(4), such examples do not necessarily imply compliance with other provisions of this paragraph (c)(4), as these examples do not analyze compliance with all other provisions of this paragraph (c)(4).

(A) Example 1 (More restrictive prior authorization requirement in operation)—(1) Facts. A plan requires prior authorization from the plan’s utilization reviewer that a treatment is medically necessary for all inpatient, in-network medical/surgical benefits and for all inpatient, in-network mental health and substance use disorder benefits. While inpatient, in-network benefits for medical/surgical conditions are approved for periods of 1, 3, and 7 days, after which a treatment plan must be submitted by the patient’s attending provider and approved by the plan, the approvals for 7 days are most common under this plan. For inpatient, in-network mental health and substance use disorder benefits, routine approval is most commonly given only for one day, after which a treatment plan must be submitted by the patient’s attending provider and approved by the plan. The difference in the duration of approvals is not the result of independent professional medical or clinical standards or standards to detect or prevent and prove fraud, waste, and abuse, but rather reflects the application of a heightened standard to the provision of the mental health and substance use disorder benefits in the relevant classification.

(2) Conclusion. In this paragraph (c)(4)(viii)(A) (Example 1), the plan violates the rules of paragraph (c)(4)(i) of this section. Under the terms of the plan, prior authorization applies to at least two-thirds of all medical/surgical benefits in the relevant classification (inpatient, in-network), since it applies to all benefits in the relevant classification. Further, the most common or frequent variation of the nonquantitative treatment limitation applied to medical/surgical benefits in the relevant classification (the predominant nonquantitative treatment limitation) is the routine approval of inpatient, in-network benefits for 7 days before the patient’s attending provider must submit a treatment plan. However, the plan routinely approves inpatient, in-network benefits for mental health and substance use disorder conditions for only 1 day before the patient’s attending provider must submit a treatment plan (and, in doing so, does not impartially apply independent professional medical or clinical standards or apply standards to detect or prevent and prove fraud, waste, and abuse that qualify for the exceptions in paragraph (c)(4)(i)(E) of this section). In operation, therefore, the prior authorization requirement imposed on inpatient, in-network mental health and substance use disorder benefits is more restrictive than the predominant prior authorization requirement applicable to substantially all medical/surgical benefits in the inpatient, in-network classification because the practice of approving only 1 day of inpatient benefits limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to the routine 7-day approval that is given for inpatient, in-network medical/surgical benefits. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(B) Example 2 (More restrictive peer-to-peer concurrent review requirements in operation)—(1) Facts. A plan follows a written process for the concurrent review of all medical/surgical benefits and mental health and substance use disorder benefits within the inpatient, in-network classification. Under the process, a first-level review is conducted in every instance in which concurrent review applies and an authorization request is approved by the first-level reviewer only if the clinical information submitted by the facility meets the plan’s criteria for a continued stay. If the first-level reviewer is unable to approve the authorization request because the clinical information submitted by the facility does not meet the plan’s criteria for a continued stay, it is sent to a second-level reviewer who will either approve or deny the request. While the written process only requires review by the second-level reviewer to either deny or approve the request, in operation, second-level reviewers for mental health and substance use disorder benefits conduct a peer-to-peer review with a provider (acting as the authorized representative of a participant or beneficiary) before coverage of the treatment is approved. The peer-to-peer review requirement is not the result of independent professional medical or clinical standards or standards to detect or prevent and prove fraud, waste, and abuse. The plan does not impose a peer-to-peer review, as written or in operation, as part of the second-level review for medical/surgical benefits.

(2) Conclusion. In this paragraph (c)(4)(viii)(B) (Example 2), the plan violates the rules of paragraph (c)(4)(i) of this section. The concurrent review nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits within the inpatient, in-network classification because the plan follows the concurrent review process for all medical/surgical benefits. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is that peer-to-peer review is not imposed as part of second-level review. The plan does not impartially apply independent professional medical or clinical standards or apply standards to detect or prevent and prove fraud, waste, and abuse that qualify for the exceptions in paragraph (c)(4)(i)(E) of this section. As written, the plan’s concurrent review requirements are the same for medical/surgical benefits and mental health and substance use disorder benefits. However, in operation, by compelling an additional action (peer-to-peer review as part of second-level review) to access only mental health or substance use disorder benefits, the plan applies the limitation to mental health and substance use disorder benefits in a manner that is more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the inpatient, in-network classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(C) Example 3 (More restrictive peer-to-peer review medical necessity standard in operation; deviation from independent professional medical and clinical standards)—(1) Facts. A plan generally requires that all treatment be medically necessary in the inpatient, out-of-network classification. For both medical/surgical benefits and mental health and substance use disorder benefits, the written medical necessity standards are based on independent professional medical or clinical standards that do not require peer-to-peer review. In operation, the plan covers out-of-network benefits for medical/surgical or mental health inpatient treatment outside of a hospital if the physician documents medical appropriateness, but for out-of-network benefits for substance use disorder inpatient treatment outside of a hospital, the plan requires a physician to also complete peer-to-peer review.

(2) Conclusion. In this paragraph (c)(4)(viii)(C) (Example 3), the plan violates the rules of paragraph (c)(4)(i) of this section. The medical necessity nonquantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits in the inpatient, out-of-network classification. The most common or frequent variation of the nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is the requirement that a physician document medical appropriateness without peer-to-peer review. The plan purports to impartially apply independent professional medical or clinical standards that would otherwise qualify for the exception in paragraph (c)(4)(i)(E) of this section, but deviates from those standards by imposing the additional requirement to complete peer-to-peer review for inpatient, out-of-network benefits for substance use disorder outside of a hospital. Therefore, the exception in paragraph (c)(4)(i)(E) of this section does not apply. As written, the plan provisions apply the nonquantitative treatment limitation to mental health and substance use disorder benefits in the inpatient, out-of-network classification in the same manner as for medical/surgical benefits. However, in operation, the nonquantitative treatment limitation imposed with respect to out-of-network substance use disorder benefits for treatment outside of a hospital is more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the classification because it limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(D) Example 4 (Not comparable and more stringent methods for determining reimbursement rates in operation)—(1) Facts. A plan’s base reimbursement rates for outpatient, in-network providers are determined based on a variety of factors, including the providers’ required training, licensure, and expertise. For purposes of this example, the plan’s nonquantitative treatment limitations for determining reimbursement rates for mental health and substance use disorder benefits are not more restrictive than the predominant nonquantitative treatment limitation applied to substantially all medical/surgical benefits in the classification under paragraph (c)(4)(i) of this section. As written, for mental health, substance use disorder, and medical/surgical benefits, all reimbursement rates for physicians and non-physician practitioners for the same Current Procedural Terminology (CPT) code vary based on a combination of factors, such as the nature of the service, provider type, number of providers qualified to provide the service in a given geographic area, and market need (demand). As a result, reimbursement rates for mental health, substance use disorder, and medical/surgical benefits furnished by non-physician providers are generally less than for physician providers. In operation, the plan reduces the reimbursement rate for mental health and substance use disorder non-physician providers from that paid to mental health and substance use disorder physicians by the same percentage for every CPT code but does not apply the same reductions for non-physician medical/surgical providers.

(2) Conclusion. In this paragraph (c)(4)(viii)(D) (Example 4), the plan violates the rules of paragraph (c)(4)(ii) of this section. Because the plan reimburses non-physician providers of mental health and substance use disorder services by reducing their reimbursement rate from the rate to physician providers by the same percentage for every CPT code but does not apply the same reductions to non-physician providers of medical/surgical services, in operation, the factors used in applying the nonquantitative treatment limitation to mental health and substance use disorder benefits are not comparable to, and are applied more stringently than, the factors used in applying the limitation with respect to medical/surgical benefits. Because the facts assume that the plan’s methods for determining reimbursement rates comply with paragraph (c)(4)(i) of this section and the plan violates the rules of paragraph (c)(4)(ii) of this section, this example does not analyze compliance with paragraph (c)(4)(iv) of this section.

(E) Example 5 (Exception for impartially applied generally recognized independent professional medical or clinical standards)—(1) Facts. A group health plan develops a medical management requirement for all inpatient, out-of-network benefits for both medical/surgical benefits and mental health and substance use disorder benefits to ensure treatment is medically necessary. The medical management requirement impartially applies independent professional medical or clinical standards in a manner that qualifies for the exception in paragraph (c)(4)(i)(E) of this section. The plan does not rely on any other factors or evidentiary standards and the processes, strategies, evidentiary standards, and other factors used in designing and applying the medical management requirement to mental health and substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in designing and applying the requirement with respect to medical/surgical benefits. Within the inpatient, out-of-network classification, the application of the medical management requirement results in a higher percentage of denials for mental health and substance use disorder claims than medical/surgical claims, because the benefits were found to be medically necessary for a lower percentage of mental health and substance use disorder claims based on the impartial application of the independent professional medical or clinical standards by the nonquantitative treatment limitation.

(2) Conclusion. In this paragraph (c)(4)(viii)(E) (Example 5), the plan does not violate the rules of this paragraph (c)(4). The medical management nonquantitative treatment limitation imposed on mental health and substance use disorder benefits does not violate paragraph (c)(4)(i) or (iv) of this section because it impartially applies independent professional medical or clinical standards for both medical/surgical benefits and mental health and substance use disorder benefits in a manner that qualifies for the exceptions in paragraphs (c)(4)(i)(E) and (c)(4)(iv)(D) of this section, respectively. Moreover, the nonquantitative treatment limitation does not violate paragraph (c)(4)(ii) of this section because the independent professional medical or clinical standards are not considered to be a discriminatory factor or evidentiary standard under paragraph (c)(4)(ii)(B) of this section. Additionally, as written and in operation, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the inpatient, out-of-network classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in applying the limitation with respect to medical/surgical benefits in the classification, regardless of the fact that the application of the nonquantitative treatment limitation resulted in higher percentages of claim denials for mental health and substance use disorder benefits as compared to medical/surgical benefits.

(F) Example 6 (More restrictive prior authorization requirement; exception for impartially applied generally recognized independent professional medical or clinical standards not met)—(1) Facts. The provisions of a plan state that it applies independent professional medical and clinical standards (consistent with generally accepted standards of care) for setting prior authorization requirements for both medical/surgical and mental health and substance use disorder prescription drugs. The relevant generally recognized independent professional medical standard for treatment of opioid use disorder that the plan utilizes—in this case, the American Society of Addiction Medicine national practice guidelines—does not support prior authorization every 30 days for buprenorphine/naloxone. However, in operation, the plan requires prior authorization for buprenorphine/naloxone combination at each refill (every 30 days) for treatment of opioid use disorder.

(2) Conclusion. In this paragraph (c)(4)(viii)(F) (Example 6), the plan violates the rules of paragraph (c)(4)(i) of this section. The plan does not qualify for the exception in paragraph (c)(4)(i)(E) of this section, because, although the provisions of the plan state that it applies independent professional medical and clinical standards, the plan deviates from the relevant standards with respect to prescription drugs to treat opioid use disorder. The prior authorization nonquantitative treatment limitation is applied to at least two-thirds of all medical/surgical benefits in the prescription drugs classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is following generally recognized independent professional medical and clinical standards (consistent with generally accepted standards of care). The prior authorization requirements imposed on substance use disorder benefits are more restrictive than the predominant nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in the classification, because the plan imposes additional requirements on substance use disorder benefits that limit access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(G) Example 7 (Impermissible nonquantitative treatment limitation imposed following a final determination of noncompliance and direction by the Secretary)—(1) Facts. Following an initial request by the Secretary for a plan’s comparative analysis of a nonquantitative treatment limitation pursuant to § 146.137(d), the plan submits a comparative analysis for the nonquantitative treatment limitation. After review of the comparative analysis, the Secretary makes an initial determination that the comparative analysis fails to demonstrate that the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the relevant classification are comparable to, and applied no more stringently than, those used in designing and applying the limitation to medical/surgical benefits in the classification. Pursuant to § 146.137(d)(3), the plan submits a corrective action plan and additional comparative analyses within 45 calendar days after the initial determination, and the Secretary then determines that the additional comparative analyses do not demonstrate compliance with the requirements of this paragraph (c)(4). The plan receives a final determination of noncompliance from the Secretary, which informs the plan that it is not in compliance with this paragraph (c)(4) and directs the plan not to impose the nonquantitative treatment limitation by a certain date, unless and until the plan demonstrates compliance to the Secretary or takes appropriate action to remedy the violation. The plan makes no changes to its plan terms by that date and continues to impose the nonquantitative treatment limitation.

(2) Conclusion. In this paragraph (c)(4)(viii)(G) (Example 7), the plan violates the requirements of this paragraph (c)(4) by imposing the nonquantitative treatment limitation after the Secretary directs the plan not to impose it, pursuant to paragraph (c)(4)(vii) of this section.

(H) Example 8 (Provider network admission standards not more restrictive and compliant with requirements for design and application of NQTLs)—(1) Facts. As part of a plan’s standards for provider admission to its network, in the outpatient, in-network classification, any provider seeking to contract with the plan must have a certain number of years of supervised clinical experience. As a result of that standard, master’s level mental health therapists are required to obtain supervised clinical experience beyond their licensure, while master’s level medical/surgical providers, psychiatrists, and Ph.D.-level psychologists do not require additional experience beyond their licensure because their licensure already requires supervised clinical experience. The plan collects and evaluates relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation. This includes in-network and out-of-network utilization rates (including data related to provider claim submissions), network adequacy metrics (including time and distance data, and data on providers accepting new patients), and provider reimbursement rates (including as compared to billed charges). This data demonstrates that participants and beneficiaries seeking outpatient care are able to access outpatient, in-network mental health and substance use disorder providers at the same frequency as outpatient, in-network medical/surgical providers, that mental health and substance use disorder providers are active in the network and are accepting new patients to the same extent as medical/surgical providers, and that mental health and substance use disorder providers are within similar time and distances to plan participants and beneficiaries as are medical/surgical providers. This data also does not identify material differences in what the plan or issuer pays psychiatrists or non-physician mental health providers, compared to physicians or non-physician medical/surgical providers, respectively, both for the same reimbursement codes and as compared to Medicare rates.

(2) Conclusion. In this paragraph (c)(4)(viii)(H) (Example 8), the plan does not violate this paragraph (c)(4). The standards for this nonquantitative treatment limitation, namely provider admission to the plan’s network, are applied to at least two-thirds of all medical/surgical benefits in the outpatient, in-network classification, as it applies to all medical/surgical benefits in the classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) that applies to substantially all medical/surgical benefits in the classification is having a certain number of years of supervised clinical experience. The standards for provider admission to the plan’s network that are imposed with respect to mental health or substance use disorder benefits are no more restrictive, as written or in operation, than the predominant variation of the nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in the classification, because the standards do not limit access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. The requirement that providers have a certain number of years of supervised clinical experience that the plan relied upon to design and apply the nonquantitative treatment limitation is not considered to discriminate against mental health or substance use disorder benefits, even though this results in the requirement that master’s level mental health therapists obtain supervised clinical experience beyond their licensure, unlike master’s level medical/surgical providers. In addition, as written and in operation, the processes, strategies, evidentiary standards, or other factors used in applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in the classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying the limitation with respect to medical/surgical benefits in the classification, because the plan applies the same standard to all providers in the classification. Finally, the plan or issuer collects and evaluates relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitation on access to mental health and substance use disorder benefits, which does not show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in the classification.

(I) Example 9 (More restrictive requirement for primary caregiver participation applied to ABA therapy)—(1) Facts. A plan generally applies medical necessity criteria in adjudicating claims for coverage of all outpatient, in-network medical/surgical and mental health and substance use disorder benefits, including ABA therapy for the treatment of ASD, which is a mental health condition. The plan’s medical necessity criteria for coverage of ABA therapy requires evidence that the participant’s or beneficiary’s primary caregivers actively participate in ABA therapy, as documented by consistent attendance in parent, caregiver, or guardian training sessions. In adding this requirement, the plan deviates from independent professional medical or clinical standards, and there are no similar medical necessity criteria requiring evidence of primary caregiver participation in order to receive coverage of any medical/surgical benefits.

(2) Conclusion. In this paragraph (c)(4)(viii)(I) (Example 9), the plan violates paragraph (c)(4)(i) of this section. The plan applies medical necessity criteria to at least two-thirds of all outpatient, in-network medical/surgical benefits, as they apply to all medical/surgical benefits in the classification. The most common or frequent variation of this nonquantitative treatment limitation (the predominant nonquantitative treatment limitation) that applies to substantially all medical/surgical benefits in the classification does not include the requirement to provide evidence that the participant’s or beneficiary’s primary caregivers actively participate in the treatment. The plan does not qualify for the exception in paragraph (c)(4)(i)(E) of this section in applying its restriction on coverage for ABA therapy because the plan deviates from the independent professional medical or clinical standards by imposing a different requirement. As a result, the nonquantitative treatment limitation imposed on mental health and substance use disorder benefits is more restrictive than the predominant medical necessity requirement imposed on substantially all medical/surgical benefits in the classification (which does not include the requirement to provide evidence that primary caregivers actively participate in treatment). Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(J) Example 10 (More restrictive exclusion for experimental or investigative treatment applied to ABA therapy)—(1) Facts. A plan, as written, generally excludes coverage for all treatments that are experimental or investigative for both medical/surgical benefits and mental health and substance use disorder benefits in the outpatient, in-network classification. As a result, the plan generally excludes experimental treatment of medical conditions and surgical procedures, mental health conditions, and substance use disorders when no professionally recognized treatment guidelines define clinically appropriate standards of care for the condition or disorder and fewer than two randomized controlled trials are available to support the treatment’s use with respect to the given condition or disorder. The plan provides benefits for the treatment of ASD, which is a mental health condition, but, in operation, the plan excludes coverage for ABA therapy to treat children with ASD, deeming it experimental. More than one professionally recognized treatment guideline defines clinically appropriate standards of care for ASD and more than two randomized controlled trials are available to support the use of ABA therapy to treat certain children with ASD.

(2) Conclusion. In this paragraph (c)(4)(viii)(J) (Example 10), the plan violates the rules of paragraph (c)(4)(i) of this section. The coverage exclusion for experimental or investigative treatment applies to at least two-thirds of all medical/surgical benefits, as it applies to all medical/surgical benefits in the outpatient, in-network classification. The most common or frequent variation of this nonquantitative treatment limitation in the classification (the predominant nonquantitative treatment limitation) applicable to substantially all medical/surgical benefits is the exclusion under the plan for coverage of experimental treatment of medical/surgical conditions when no professionally recognized treatment guidelines define clinically appropriate standards of care for the condition or disorder and fewer than two randomized controlled trials are available to support the treatment’s use with respect to the given condition or procedure. In operation, the exclusion for experimental or investigative treatment imposed on ABA therapy is more restrictive than the predominant variation of the nonquantitative treatment limitation for experimental or investigative treatment imposed on substantially all medical/surgical benefits in the classification because the exclusion limits access to the full range of treatment options available for a condition or disorder under the plan or coverage as compared to medical/surgical benefits in the same classification. Because the plan violates the rules of paragraph (c)(4)(i) of this section, this example does not analyze compliance with paragraph (c)(4)(ii) or (iv) of this section.

(K) Example 11 (Separate EAP exhaustion treatment limitation applicable only to mental health benefits)—(1) Facts. An employer maintains both a major medical plan and an employee assistance program (EAP). The EAP provides, among other benefits, a limited number of mental health or substance use disorder counseling sessions, which, together with other benefits provided by the EAP, are not significant benefits in the nature of medical care. Participants are eligible for mental health or substance use disorder benefits under the major medical plan only after exhausting the counseling sessions provided by the EAP. No similar exhaustion requirement applies with respect to medical/surgical benefits provided under the major medical plan.

(2) Conclusion. In this paragraph (c)(4)(viii)(K) (Example 11), limiting eligibility for mental health and substance use disorder benefits under the major medical plan until EAP benefits are exhausted is a nonquantitative treatment limitation subject to the parity requirements of this paragraph (c). Because the limitation does not apply to medical/surgical benefits, it is a separate nonquantitative treatment limitation applicable only to mental health and substance use disorder benefits that violates paragraph (c)(4)(vi) of this section. Additionally, this EAP would not qualify as excepted benefits under §146.145(b)(3)(vi)(B)(1) because participants in the major medical plan are required to use and exhaust benefits under the EAP (making the EAP a gatekeeper) before an individual is eligible for benefits under the plan.

(L) Example 12 (Separate residential exclusion treatment limitation applicable only to mental health benefits)—(1) Facts. A plan generally covers inpatient, in-network and inpatient out-of-network treatment in any setting, including skilled nursing facilities and rehabilitation hospitals, provided other medical necessity standards are satisfied. The plan also has an exclusion for residential treatment, which the plan defines as an inpatient benefit, for mental health and substance use disorder benefits. This exclusion was not generated through any broader nonquantitative treatment limitation (such as medical necessity or other clinical guideline).

(2) Conclusion. In this paragraph (c)(4)(viii)(L) (Example 12), the plan violates the rules of paragraph (c)(4)(vi) of this section. Because the plan does not apply a comparable exclusion to inpatient benefits for medical/surgical conditions, the exclusion of residential treatment is a separate nonquantitative treatment limitation applicable only to mental health and substance use disorder benefits in the inpatient, in-network and inpatient, out-of-network classifications that does not apply with respect to any medical/surgical benefits in the same benefit classification.

(M) Example 13 (Standards for provider admission to a network)—(1) Facts. A plan applies nonquantitative treatment limitations related to network composition in the outpatient in-network and inpatient, in-network classifications. The plan’s networks are constructed by separate service providers for medical/surgical benefits and mental health and substance use disorder benefits. For purposes of this example, these facts assume that these nonquantitative treatment limitations related to network composition for mental health and substance use disorder benefits are not more restrictive than the predominant nonquantitative treatment limitations applied to substantially all medical/surgical benefits in the classifications under paragraph (c)(4)(i) of this section. The facts also assume that, as written and in operation, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitations related to network access to mental health or substance use disorder benefits in the outpatient in-network and inpatient in-network classifications are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitations with respect to medical/surgical benefits in the classifications, as required under paragraph (c)(4)(ii) of this section. The plan collects and evaluates all relevant data in a manner reasonably designed to assess the impact of the nonquantitative treatment limitations related to network composition on access to mental health and substance use disorder benefits as compared with access to medical/surgical benefits and considers the impact as part of the plan’s or issuer’s analysis of whether the standards, in operation, comply with paragraphs (c)(4)(i) and (ii) of this section. The plan determined that the data did not reveal any material differences in access. That data included metrics relating to the time and distance from plan participants and beneficiaries to network providers in rural and urban regions; the number of network providers accepting new patients; the proportions of mental health and substance use disorder and medical/surgical providers and facilities that provide services in rural and urban regions who are in the plan’s network; provider reimbursement rates; in-network and out-of-network utilization rates (including data related to the dollar value and number of provider claims submissions); and survey data from participants on the extent to which they forgo or pay out-of-pocket for treatment because of challenges finding in-network providers. The efforts the plan made when designing and applying its nonquantitative treatment limitations related to network composition, which ultimately led to its outcomes data not revealing any material differences in access to benefits for mental health or substance use disorders as compared with medical/surgical benefits, included making sure that the plan’s service providers are making special efforts to enroll available providers, including by authorizing greater compensation or other inducements to the extent necessary, and expanding telehealth arrangements as appropriate to manage regional shortages. The plan also notifies participants in clear and prominent language on its website, employee brochures, and the summary plan description of a toll-free number available to help participants find in-network providers. In addition, when plan participants submit bills for out-of-network items and services, the plan directs their service providers to reach out to the treating providers and facilities to see if they will enroll in the network.

(2) Conclusion. In this paragraph (c)(4)(viii)(M) (Example 13), the plan does not violate this paragraph (c)(4). As stated in the Facts section, the plan’s nonquantitative treatment limitations related to network composition comply with the rules of paragraphs (c)(4)(i) and (ii) of this section. The plan collects and evaluates relevant data, as required under paragraph (c)(4)(iv)(A) of this section, and the data does not reveal any material differences in access to mental health and substance use disorder benefits as compared to medical/surgical benefits, as a result of the actions the plan took (as set forth in the facts) when initially designing its nonquantitative treatment limitations related to network composition. Because the plan takes comparable actions to ensure that their mental health and substance use disorder provider network is as accessible as their medical/surgical provider network and exercises careful oversight over both their service providers and the comparative robustness of the networks with an eye to ensuring that network composition results in access to in-network benefits for mental health and substance use disorder services that is as generous as for medical/surgical services, plan participants and beneficiaries can access covered mental health and substance use disorder services and benefits as readily as medical/surgical benefits. This is reflected in the plan’s carefully designed metrics and assessment of network composition.

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(d) * * *

(3) Provisions of other law. Compliance with the disclosure requirements in paragraphs (d)(1) and (2) of this section is not determinative of compliance with any other provision of applicable Federal or State law. In particular, in addition to those disclosure requirements, provisions of other applicable law require disclosure of information relevant to medical/surgical, mental health, and substance use disorder benefits. For example, § 147.136 of this subchapter sets forth rules regarding claims and appeals, including the right of claimants (or their authorized representative) upon appeal of an adverse benefit determination (or a final internal adverse benefit determination) to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the claimant’s claim for benefits. This includes documents with information on medical necessity criteria for both medical/surgical benefits and mental health and substance use disorder benefits, as well as the processes, strategies, evidentiary standards, and other factors used to apply a nonquantitative treatment limitation with respect to medical/surgical benefits and mental health or substance use disorder benefits under the plan and the comparative analyses and other applicable information required by § 146.137.

(e) * * *

(4) Coordination with EHB requirements. Nothing in paragraph (f) or (g) of this section or § 146.137(g) changes the requirements of §§ 147.150 and 156.115 of this subchapter, providing that a health insurance issuer offering non-grandfathered health insurance coverage in the individual or small group market providing mental health and substance use disorder services, including behavioral health treatment services, as part of essential health benefits required under §§ 156.110(a)(5) and 156.115(a) of this subchapter, must comply with the requirements under section 2726 of the PHS Act and its implementing regulations in this subchapter to satisfy the requirement to provide coverage for mental health and substance use disorder services, including behavioral health treatment, as part of essential health benefits.

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(i) * * *

(1) In general. Except as provided in paragraph (i)(2) of this section, this section applies to group health plans and health insurance issuers offering group health insurance coverage on the first day of the first plan year beginning on or after January 1, 2025. Until the applicability date in the preceding sentence, plans and issuers are required to continue to comply with 45 CFR 146.136, revised as of October 1, 2021.

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(j) Severability. If any provision of this section is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, the provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

9. Add § 146.137 to read as follows:

(a) Meaning of terms. Unless otherwise stated in this section, the terms of this section have the meanings indicated in § 146.136(a)(2).

(b) In general. In the case of a group health plan (or health insurance issuer offering group health insurance coverage in connection with a group health plan) that provides both medical/surgical benefits and mental health or substance use disorder benefits and that imposes any nonquantitative treatment limitation on mental health or substance use disorder benefits, the plan or issuer must perform and document a comparative analysis of the design and application of each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits. Each comparative analysis must comply with the content requirements of paragraph (c) of this section and be made available to the Secretary, upon request, in the manner required by paragraphs (d) and (e) of this section.

(c) Comparative analysis content requirements. With respect to each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits under a group health plan (or health insurance coverage offered in connection with a group health plan), the comparative analysis performed by the plan or issuer must include, at minimum, the elements specified in this paragraph (c). In addition to the comparative analysis for each nonquantitative treatment limitation, each plan or issuer must prepare and make available to the Secretary, upon request, a written list of all nonquantitative treatment limitations imposed under the plan or coverage and a general description of any information considered or relied upon by the plan or issuer in preparing the comparative analysis for each nonquantitative treatment limitation.

(1) Description of the nonquantitative treatment limitation. The comparative analysis must include, with respect to the nonquantitative treatment limitation that is the subject of the comparative analysis:

(i) Identification of the nonquantitative treatment limitation, including the specific terms of the plan or coverage or other relevant terms regarding the nonquantitative treatment limitation, the policies or guidelines (internal or external) in which the nonquantitative treatment limitation appears or is described, and the applicable sections of any other relevant documents, such as provider contracts, that describe the nonquantitative treatment limitation;

(ii) Identification of all mental health or substance use disorder benefits and medical/surgical benefits to which the nonquantitative treatment limitation applies, including a list of which benefits are considered mental health or substance use disorder benefits and which benefits are considered medical/surgical benefits;

(iii) A description of which benefits are included in each classification set forth in § 146.136(c)(2)(ii)(A); and

(iv) Identification of the predominant nonquantitative treatment limitation applicable to substantially all medical/surgical benefits in each classification, including an explanation of how the plan or issuer determined which variation is the predominant nonquantitative treatment limitation as compared to other variations, as well as how the plan identified the variations of the nonquantitative treatment limitation.

(2) Identification and definition of the factors used to design or apply the nonquantitative treatment limitation. The comparative analysis must include, with respect to every factor considered or relied upon to design the nonquantitative treatment limitation or apply the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits:

(i) Identification of all of the factors considered, as well as the evidentiary standards considered or relied upon to design or apply each factor and the sources from which each evidentiary standard was derived, in determining which mental health or substance use disorder benefits and which medical/surgical benefits are subject to the nonquantitative treatment limitation; and

(ii) A definition of each factor, including:

(A) A detailed description of the factor; and

(B) A description of each evidentiary standard (and the source of each evidentiary standard) identified under paragraph (c)(2)(i) of this section.

(3) Description of how factors are used in the design and application of the nonquantitative treatment limitation. The comparative analysis must include a description of how each factor identified and defined pursuant to paragraph (c)(2) of this section is used in the design or application of the nonquantitative treatment limitation to mental health and substance use disorder benefits and medical/surgical benefits in a classification, including:

(i) A detailed explanation of how each factor identified and defined in paragraph (c)(2) of this section is used to determine which mental health or substance use disorder benefits and which medical/surgical benefits are subject to the nonquantitative treatment limitation;

(ii) An explanation of the evidentiary standards or other information or sources (if any) considered or relied upon in designing or applying the factors or relied upon in designing and applying the nonquantitative treatment limitation, including in the determination of whether and how mental health or substance use disorder benefits or medical/surgical benefits are subject to the nonquantitative treatment limitation;

(iii) If the application of the factor depends on specific decisions made in the administration of benefits, the nature of the decisions, the timing of the decisions, and the professional designation and qualifications of each decision maker;

(iv) If more than one factor is identified and defined in paragraph (c)(2) of this section, an explanation of:

(A) How all of the factors relate to each other;

(B) The order in which all the factors are applied, including when they are applied;

(C) Whether and how any factors are given more weight than others; and

(D) The reasons for the ordering or weighting of the factors; and

(v) Any deviation(s) or variation(s) from a factor, its applicability, or its definition (including the evidentiary standards used to define the factor and the information or sources from which each evidentiary standard was derived), such as how the factor is used differently to apply the nonquantitative treatment limitation to mental health or substance use disorder benefits as compared to medical/surgical benefits, and a description of how the plan or issuer establishes such deviation(s) or variation(s).

(4) Demonstration of comparability and stringency as written. The comparative analysis must evaluate whether, in any classification, under the terms of the plan (or health insurance coverage) as written, any processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder 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 nonquantitative treatment limitation with respect to medical/surgical benefits. The comparative analysis must include, with respect to the nonquantitative treatment limitation and the factors used in designing and applying the nonquantitative treatment limitation:

(i) Documentation of each factor identified and defined in paragraph (c)(2) of this section that was applied to determine whether the nonquantitative treatment limitation applies to mental health or substance use disorder benefits and medical/surgical benefits in a classification, including, as relevant:

(A) Quantitative data, calculations, or other analyses showing whether, in each classification in which the nonquantitative treatment limitation applies, mental health or substance use disorder benefits and medical/surgical benefits met or did not meet any applicable threshold identified in the relevant evidentiary standard, and the evaluation of relevant data as required under § 146.136(c)(4)(iv)(A), to determine that the nonquantitative treatment limitation would or would not apply; and

(B) Records maintained by the plan or issuer documenting the consideration and application of all factors and evidentiary standards, as well as the results of their application;

(ii) In each classification in which the nonquantitative treatment limitation applies to mental health or substance use disorder benefits, a comparison of how the nonquantitative treatment limitation, as written, is applied to mental health or substance use disorder benefits and to medical/surgical benefits, including the specific provisions of any forms, checklists, procedure manuals, or other documentation used in designing and applying the nonquantitative treatment limitation or that address the application of the nonquantitative treatment limitation;

(iii) Documentation demonstrating how the factors are comparably applied, as written, to mental health or substance use disorder benefits and medical/surgical benefits in each classification, to determine which benefits are subject to the nonquantitative treatment limitation; and

(iv) An explanation of the reason(s) for any deviation(s) or variation(s) in the application of a factor used to apply the nonquantitative treatment limitation, or the application of the nonquantitative treatment limitation, to mental health or substance use disorder benefits as compared to medical/surgical benefits, and how the plan or issuer establishes such deviation(s) or variation(s), including:

(A) In the definition of the factors, the evidentiary standards used to define the factors, and the sources from which the evidentiary standards were derived;

(B) In the design of the factors or evidentiary standards; or

(C) In the application or design of the nonquantitative treatment limitation.

(5) Demonstration of comparability and stringency in operation. The comparative analysis must evaluate whether, in any classification, under the terms of the plan (or health insurance coverage) in operation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder 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. The comparative analysis must include, with respect to the nonquantitative treatment limitation and the factors used in designing and applying the nonquantitative treatment limitation:

(i) A comprehensive explanation of how the plan or issuer ensures that, in operation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in a classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in designing and applying the nonquantitative treatment limitation with respect to medical/surgical benefits, including:

(A) An explanation of any methodology and underlying data used to demonstrate the application of the nonquantitative treatment limitation, in operation; and

(B) The sample period, inputs used in any calculations, definitions of terms used, and any criteria used to select the mental health or substance use disorder benefits and medical/surgical benefits to which the nonquantitative treatment limitation is applicable;

(ii) Identification of the relevant data collected and evaluated as required under § 146.136(c)(4)(iv)(A);

(iii) An evaluation of the outcomes that resulted from the application of the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits, including the relevant data as required under § 146.136(c)(4)(iv)(A);

(iv) A detailed explanation of material differences in outcomes evaluated pursuant to paragraph (c)(5)(iii) of this section that are not attributable to differences in the comparability or relative stringency of the nonquantitative treatment limitation as applied to mental health or substance use disorder benefits and medical/surgical benefits and the bases for concluding that material differences in outcomes are not attributable to differences in the comparability or relative stringency of the nonquantitative treatment limitation; and

(v) A discussion of any measures that have been or are being implemented by the plan or issuer to mitigate any material differences in access to mental health or substance use disorder benefits as compared to medical/surgical benefits, including the actions the plan or issuer is taking under § 146.136(c)(4)(iv)(B)(1) to address material differences to ensure compliance with § 146.136(c)(4)(i) and (ii).

(6) Findings and conclusions. The comparative analysis must address the findings and conclusions as to the comparability of the processes, strategies, evidentiary standards, and other factors used in designing and applying the nonquantitative treatment limitation to mental health or substance use disorder benefits and medical/surgical benefits within each classification, and the relative stringency of their application, both as written and in operation, and include:

(i) Any findings or conclusions indicating that the plan or coverage is not (or might not be) in compliance with the requirements of § 146.136(c)(4), including any actions the plan or issuer has taken or intends to take to address any potential areas of concern or noncompliance;

(ii) A reasoned and detailed discussion of the findings and conclusions described in paragraph (c)(6)(i) of this section;

(iii) Citations to any additional specific information not otherwise included in the comparative analysis that supports the findings and conclusions described in paragraph (c)(6)(i) of this section;

(iv) The date of the analysis and the title and credentials of all relevant persons who participated in the performance and documentation of the comparative analysis; and

(v) If the comparative analysis relies upon an evaluation by a reviewer or consultant considered by the plan or issuer to be an expert, an assessment of each expert’s qualifications and the extent to which the plan or issuer ultimately relied upon each expert’s evaluation in performing and documenting the comparative analysis of the design and application of each nonquantitative treatment limitation applicable to both mental health or substance use disorder benefits and medical/surgical benefits.

(d) Requirements related to submission of comparative analyses to the Secretary upon request—(1) Initial request by the Secretary for comparative analysis. A group health plan or health insurance issuer offering group health insurance coverage must make the comparative analysis required by paragraph (b) of this section available and submit it to the Secretary within 10 business days of receipt of a request from the Secretary (or an additional period of time specified by the Secretary).

(2) Additional information required after a comparative analysis is deemed to be insufficient. In instances in which the Secretary determines that the plan or issuer has not submitted sufficient information under paragraph (d)(1) of this section for the Secretary to review the comparative analysis required in paragraph (b) of this section, the Secretary will specify to the plan or issuer the additional information the plan or issuer must submit to the Secretary to be responsive to the request under paragraph (d)(1) of this section. Any such information must be provided to the Secretary by the plan or issuer within 10 business days after the Secretary specifies the additional information to be submitted (or an additional period of time specified by the Secretary).

(3) Initial determination of noncompliance, required action, and corrective action plan. In instances in which the Secretary reviewed the comparative analysis submitted under paragraph (d)(1) of this section and any additional information submitted under paragraph (d)(2) of this section, and made an initial determination that the plan or issuer is not in compliance with the requirements of § 146.136(c)(4) or this section, the plan or issuer must respond to the Secretary and specify the actions the plan or issuer will take to bring the plan or coverage into compliance, and provide to the Secretary additional comparative analyses meeting the requirements of paragraph (b) of this section that demonstrate compliance with § 146.136(c)(4) and this section, not later than 45 calendar days after the Secretary’s initial determination that the plan or issuer is not in compliance.

(4) Requirement to notify participants and beneficiaries of final determination of noncompliance—(i) In general. If the Secretary makes a final determination of noncompliance, the plan or issuer must notify all participants and beneficiaries enrolled in the plan or coverage that the plan or issuer has been determined to not be in compliance with the requirements of § 146.136(c)(4) or this section with respect to such plan or coverage. Such notice must be provided within 7 calendar days of receipt of the final determination of noncompliance, and the plan or issuer must provide a copy of the notice to the Secretary, and any service provider involved in the claims process.

(ii) Content of notice. The notice to participants and beneficiaries required in paragraph (d)(4)(i) of this section shall be written in a manner calculated to be understood by the average plan participant and must include, in plain language, the following information in a standalone notice:

(A) The following statement prominently displayed on the first page, in no less than 14-point font: “Attention! The Department of Health and Human Services 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.”;

(B) A summary of changes the plan or issuer has made as part of its corrective action plan specified to the Secretary following the initial determination of noncompliance, including an explanation of any opportunity for a participant or beneficiary to have a claim for benefits reprocessed;

(C) A summary of the Secretary’s final determination that the plan or issuer is not in compliance with § 146.136(c)(4) or this section, including any provisions or practices identified as being in violation of MHPAEA, additional corrective actions identified by the Secretary in the final determination notice, and information on how participants and beneficiaries can obtain from the plan or issuer a copy of the final determination of noncompliance;

(D) Any additional actions the plan or issuer is taking to come into compliance with § 146.136(c)(4) or this section, when the plan or issuer will take such actions, and a clear and accurate statement explaining whether the Secretary has indicated that those actions, if completed, will result in compliance; and

(E) Contact information for questions and complaints, and a statement explaining how participants and beneficiaries can obtain more information about the notice, including:

(1) The plan’s or issuer’s phone number and an email or web portal address; and

(2) The Center for Medicare and Medicaid Services’ phone number and email or web portal address.

(iii) Manner of notice. The plan or issuer must make the notice required under paragraph (d)(4)(i) of this section available in paper form, or electronically (such as by email or an Internet posting) if:

(A) The format is readily accessible;

(B) The notice is provided in paper form free of charge upon request; and

(C) In a case in which the electronic form is an internet posting, the plan or issuer timely notifies the participant or beneficiary in paper form (such as a postcard) or email, that the documents are available on the internet, provides the internet address, includes the statement required in paragraph (d)(4)(ii)(A) of this section, and notifies the participant or beneficiary that the documents are available in paper form upon request.

(e) Requests for a copy of a comparative analysis. In addition to making a comparative analysis available upon request to the Secretary, a plan or issuer must make available a copy of the comparative analysis required by paragraph (b) of this section when requested by:

(1) Any applicable State authority; and

(2) A participant or beneficiary (or a provider or other person acting as a participant’s or beneficiary’s authorized representative) who has received an adverse benefit determination related to mental health or substance use disorder benefits.

(f) Rule of construction. Nothing in this section or § 146.136 shall be construed to prevent the Secretary from acting within the scope of existing authorities to address violations of § 146.136 or this section.

(g) Applicability. The provisions of this section apply to group health plans and health insurance issuers offering group health insurance coverage described in § 146.136(e), to the extent the plan or issuer is not exempt under § 146.136(f) or (g), for plan years beginning on or after January 1, 2025.

(h) Severability. If any provision of this section is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, the provision shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

9. Amend § 146.180 by:

a. Revising paragraph (a)(2);

b. Redesignating paragraphs (a)(3) through (7) as paragraphs (a)(4) through (8);

c. Adding new paragraph (a)(3);

d. Revising newly redesignated paragraphs (a)(5) and (a)(7)(i) and paragraph (f)(1); and

e. Adding paragraph (f)(4)(iii).

The revisions and additions read as follows:

(a) * * *

(2) General rule. For plans years beginning on or after September 23, 2010, a sponsor of a non-Federal governmental plan may elect to exempt its plan, to the extent the plan is not provided through health insurance coverage (that is self-funded), from one or more of the requirements described in paragraphs (a)(1)(iv) through (vii) of this section, except as provided in paragraphs (a)(3) and (f)(1) of this section with respect to the requirements described in paragraph (a)(1)(v) of this section.

(3) Sunset of election option related to parity in mental health and substance use disorder benefits. A sponsor of a non-Federal governmental plan may not newly elect to exempt its plan(s) from the requirements described in paragraph (a)(1)(v) of this section on or after December 29, 2022.

* * * * *

(5) Examples – (i) Example 1. A non-Federal governmental employer has elected to exempt its self-funded group health plan from all of the requirements described in paragraph (a)(1) of this section. The plan year commences September 1 of each year. The plan is not subject to the provisions of paragraph (a)(2) of this section until the plan year that commences on September 1, 2011. Accordingly, for that plan year and any subsequent plan years, the plan sponsor may elect to exempt its plan only from the requirements described in paragraphs (a)(1)(iv) through (vii) of this section, subject to paragraphs (a)(3) and (f)(1) of this section with respect to the requirements described in paragraph (a)(1)(v) of this section.

(ii) Example 2. A non-Federal governmental employer has elected to exempt its collectively bargained self-funded plan from all of the requirements described in paragraph (a)(1) of this section. The collective bargaining agreement applies to 5 plan years, October 1, 2009 through September 30, 2014. For the plan year that begins on October 1, 2014, the plan sponsor is no longer permitted to elect to exempt its plan from the requirements described in paragraphs (a)(1)(i) through (iii) of this section. Accordingly, for that plan year and any subsequent plan years, the plan sponsor may elect to exempt its plan only from the requirements described in paragraphs (a)(1)(iv) through (vii) of this section, subject to paragraphs (a)(3) and (f)(1) of this section with respect to the requirements described in paragraph (a)(1)(v) of this section.

* * * * *

(7) * * *

(i) Subject to paragraph (a)(7)(ii) of this section, the purchase of stop-loss or excess risk coverage by a self-funded non-Federal governmental plan does not prevent an election under this section.

* * * * *

(f) * * *

(1) Election renewal. A plan sponsor may renew an election under this section through subsequent elections. Notwithstanding the previous sentence and except as provided in paragraph (f)(4)(iii) of this section, an election with respect to the requirements described in paragraph (a)(1)(v) of this section expiring on or after June 27, 2023, may not be renewed. The timeliness standards described in paragraph (c) of this section apply to election renewals under paragraph (f) of this section.

* * * * *

(4) * * *

(iii) In the case of a plan that is subject to multiple collective bargaining agreements of varying lengths and that has an election with respect to the requirements described in paragraph (a)(1)(v) of this section in effect as of December 29, 2022, that expires on or after June 27, 2023, the plan may extend such election until the date on which the term of the last such agreement expires.

* * * * *

10. The authority citation for part 147 continues to read as follows:

Authority: 42 U.S.C. 300gg through 300gg–63, 300gg–91, 300gg–92, and 300gg–111 through 300gg–139, as amended, and section 3203, Pub. L. 116–136, 134 Stat. 281.

11. Revise § 147.160 to read as follows:

(a) In general. The provisions of §§ 146.136 and 146.137 of this subchapter apply to individual health insurance coverage offered by a health insurance issuer in the same manner and to the same extent as such provisions apply to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the large group market.

(b) Applicability date. The provisions of this section apply for policy years beginning on or after January 1, 2026. Until the applicability date in the preceding sentence, issuers are required to continue to comply with 45 CFR 147.160, revised as of October 1, 2021. This section applies to non-grandfathered and grandfathered health plans as defined in § 147.140.

(Filed by the Office of the Federal Register July 31, 2023, 8:45 a.m., and published in the issue of the Federal Register for August 3, 2023, 88 FR 51552)

¹ Department of Health and Human Services (2023). SAMHSA Announces National Survey on Drug Use and Health (NSDUH) Results Detailing Mental Illness and Substance Use Levels in 2021. Retrieved from https://www.hhs.gov/about/news/2023/01/04/samhsa-announces-national-survey-drug-use-health-results-detailing-mental-illness-substance-use-levels-2021.html.

² Vahratian, A., Blumberg, S. J., Terlizzi, E. P., Schiller, J. S. (2021). Symptoms of Anxiety or Depressive Disorder and Use of Mental Health Care Among Adults During the COVID-19 Pandemic — United States, August 2020–February 2021. MMWR Morb Mortal Wkly Rep 2021;70:490–494. DOI: http://dx.doi.org/10.15585/mmwr.mm7013e2.

³ Id.

⁴ Hedegaard, H., Miniño, A. M., Wagner, M. (2020). Drug Overdose Deaths in the United States, 1999-2019. NCHS Data Brief No. 304 (December 2020) https://www.cdc.gov/nchs/data/databriefs/db394-H.pdf; Centers for Disease Control and Prevention, National Center for Health Statistics. Vital Statistics Rapid Release: Provisional Drug Overdose Death Counts. Available at https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed on July 14, 2023.

⁵ Hedegaard H, Spencer MR. Urban–rural differences in drug overdose death rates, 1999–2019. NCHS Data Brief, no 403. Hyattsville, MD: National Center for Health Statistics. 2021. DOI: https://dx.doi.org/10.15620/cdc:102891.

⁶ Spencer MR, Garnett MF, Miniño AM. Urban–rural differences in drug overdose death rates, 2020. NCHS Data Brief, no 440. Hyattsville, MD: National Center for Health Statistics. 2022. DOI: https://dx.doi.org/10.15620/cdc:118601.

⁷ National Vital Statistics System. Provisional Drug Overdose Death Counts. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/202205.htm.

⁸ Friedman, Joseph R, and Helena Hansen (2022). Research Letter: Evaluation of Increases in Drug Overdose Mortality Rates in the US by Race and Ethnicity Before and During the COVID-19 Pandemic. JAMA Psychiatry. https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2789697?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamapsychiatry.2022.0004.

⁹ Id.

¹⁰ Mental Health America (2022). Youth Ranking 2022. https://mhanational.org/issues/2022/mental-health-america-youth-data.

¹¹ Sheridan D, Grusing S, Marshall R. (2022) Changes in Suicidal Ingestion Among Preadolescent Children from 2000 to 2020. JAMA Pediatrics. https://jamanetwork.com/journals/jamapediatrics/article-abstract/2789948; see also CDC, Youth Risk Behavior Survey, available at https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf.

¹² Bridge JA, Horowitz LM, Fontanella CA, et al. (2018). Age-Related Racial Disparity in Suicide Rates Among US Youths From 2001 Through 2015. JAMA Pediatrics. https://jamanetwork.com/journals/jamapediatrics/fullarticle/2680952.

¹³ The Trevor Project (2022). 2022 National Survey on LGBTQ Youth Mental Health. https://www.thetrevorproject.org/survey-2022/.

¹⁴ The Trevor Project (2022). The Mental Health and Well-Being of Multiracial LGBTQ Youth. https://www.thetrevorproject.org/research-briefs/the-mental-health-and-well-being-of-multiracial-lgbtq-youth-aug-2022/.

¹⁵ Radhakrishnan L, Leeb R, Bitsko R, Carey K, Gates A, Holland K, Hartnett K, Kite-Powell A, DeVies J, Smith A, van Santen K, Crossen S, Sheppard M, Wotiz S, Lane R, Njai R, Johnson A, Winn A, Kirking H, Rodgers L, Thomas C, Soetebier K, Adjemian J, Anderson K. (2022) Pediatric Emergency Department Visits Associated with Mental Health Conditions Before and During the COVID-19 Pandemic — United States, January 2019–January 2022. MMWR Morb Mortal Wkly Rep 2022; 71(8);319-324. https://www.cdc.gov/mmwr/volumes/71/wr/mm7108e2.htm.

¹⁶ Id.

¹⁷ Stuart B. Murray, Aaron J. Blashill, and Jerel P. Calzo (2022). Prevalence of Disordered Eating and Associations With Sex, Pubertal Maturation, and Weight in Children in the US, available at https://jamanetwork.com/journals/jamapediatrics/article-abstract/2794847.

¹⁸ Centers for Disease Control and Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, U.S. Teen Girls Experiencing Increased Sadness and Violence (Feb. 13, 2023), available at https://www.cdc.gov/nchhstp/newsroom/2023/increased-sadness-and-violence-press-release.html.

¹⁹ Van Boekel, L. C., Brouwers, E. P., van Weeghel, J., & Garretsen, H. F. (2013). Stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review. Drug and Alcohol Dependence, 131(1-2), 23–35. DOI: 10.1016/j.drugalcdep.2013.02.018, available at https://pubmed.ncbi.nlm.nih.gov/23490450/.

²⁰ Cf. Jack Turbin. Ghost networks of psychiatrists make money for insurance companies but hinder patients’ access to care. Stat News, June 17, 2019, https://www.statnews.com/2019/06/17/ghost-networks-psychiatrists-hinder-patient-care/

²¹ National Alliance on Mental Illness (2021). Mood Disorder Survey Report. https://nami.org/NAMI/media/NAMI-Media/Research/NAMI-Mood-Disorder-Survey-White-Paper.pdf.

²² Esther Adeniran, Megan Quinn, Richard Wallace, Rachel R. Walden, Titilola Labisi, Afolakemi Olaniyan, Billy Brooks, Robert Pack (2023). A scoping review of barriers and facilitators to the integration of substance use treatment services into US mainstream health care, Drug and Alcohol Dependence Reports; Volume 7, 100152 https://www.sciencedirect.com/science/article/pii/S2772724623000227.

²³ Center for Behavioral Health Statistics and Quality (2022), Results from the 2021 National Survey on Drug Use and Health: Detailed Tables, Substance Abuse and Mental Health Services Administration, available at https://www.samhsa.gov/data/report/2021-nsduh-detailed-tables. For this purpose, “any treatment” includes having participated in a mutual aid group, such as Alcoholics Anonymous, Narcotics Anonymous, or SMART Recovery, and receiving services in a hospital through primary care.

²⁴ Id.

²⁵ Health Resources and Services Administration, Designated Health Professional Shortage Areas Statistics (data updated through June 30, 2023), available at https://data.hrsa.gov/Default/GenerateHPSAQuarterlyReport (last accessed July 18, 2023).

²⁶ Borders, TF. Major Depression, Treatment Receipt, and Treatment Sources among Non-Metropolitan and Metropolitan Adults. Lexington, KY: Rural and Underserved Health Research Center; 2020. Available at https://www.ruralhealthresearch.org/publications/1348.

²⁷ See, generally, Commonwealth Fund, Behavioral Health Care in the United States: How It Works and Where It Falls Short, available at https://www.commonwealthfund.org/publications/explainer/2022/sep/behavioral-health-care-us-how-it-works-where-it-falls-short.

²⁸ See National Alliance on Mental Illness, Mental Health By the Numbers, available at https://www.nami.org/mhstats (showing 8.4 million people in the U.S. provide care to an adult with a mental or emotional health issue); KFF, KFF/CNN Mental Health In America Survey, available at https://www.kff.org/other/report/kff-cnn-mental-health-in-america-survey/ (showing half of adults say they have had a severe mental health crisis in their family); California Health Care Foundation, In Their Own Words: How Fragmented Care Harms People with Both Mental Illness and Substance Use Disorder, available at https://www.chcf.org/publication/fragmented-care-harms-people-mental-illness-substance-use-disorder/.

²⁹ See Busch, Susan H. and Kelly Kyanko, Assessment of Perception of Mental Health vs. Medical Health Plan Networks Among US Adults with Private Insurance, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8536951/.

³⁰ See Kelly A. Kyanko, Leslie A. Curry, and Susan H. Busch, Out-of-Network Providers Use More Likely in Mental Health than General Health Care Among Privately Insured, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4707657/.

³¹ Melek, S., Davenport, S., Gray, T. J. (2019). Addiction and mental health vs. physical health: Widening disparities in network use and provider reimbursement (p. 6). Milliman. https://assets.milliman.com/ektron/Addiction_and_mental_health_vs_physical_health_Widening_disparities_in_network_use_and_provider_reimbursement.pdf.

³² Id.

³³ Id. at pp. 6-7.

³⁴ See Busch, Susan H. and Kelly Kyanko, Assessment of Perception of Mental Health vs. Medical Health Plan Networks Among US Adults with Private Insurance, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8536951/.

³⁵ In a floor statement, Representative Patrick Kennedy (D-RI), one of the chief architects of MHPAEA, made the case for its passage on the grounds that “access to mental health services is one of the most important and most neglected civil rights issues facing the Nation. For too long, persons living with mental disorders have suffered from discriminatory treatment at all levels of society” 153 Cong. Rec. S1864-5 (daily ed. Feb. 12, 2007). Cf. H. Rept. 110-374, Part 3, available at https://www.congress.gov/congressional-report/110th-congress/house-report/374. (“The purpose of H.R. 1424, the ‘Paul Wellstone Mental Health and Addiction Equity Act of 2007’ is to have fairness and equity in the coverage of mental health and substance-related disorders vis-a-vis coverage for medical and surgical disorders.”)

³⁶ Internal Revenue Code (Code) section 9812(a)(3)(A), Employee Retirement Income Security Act of 1974 (ERISA) section 712(a)(3)(A), and Public Health Service Act (PHS Act) section 2726(a)(3)(A).

³⁷ 2022 MHPAEA Report to Congress, p. 4, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf and https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf; 2023 MHPAEA Comparative Analysis Report to Congress, July 2023 (2023 MHPAEA Report to Congress), available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf and https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity.

³⁸ As discussed in more detail later in this preamble, NQTLs are generally non-numerical requirements that limit the scope or duration of benefits, such as prior authorization requirements, step therapy, and standards for provider admission to participate in a network, including methodologies for determining reimbursement rates.

³⁹ PHS Act section 2723(b).

⁴⁰ PHS Act section 2723(a).

⁴¹ CMS currently enforces MHPAEA with respect to issuers in Texas and Wyoming. In addition, CMS has collaborative enforcement agreements with Alabama, Florida, Louisiana, Montana, and Wisconsin. These States with collaborative enforcement agreements with CMS perform State regulatory and oversight functions with respect to some or all of the applicable provisions of title XXVII of the PHS Act, including MHPAEA. However, if the State finds a potential violation and is unable to obtain compliance by an issuer, the State will refer the matter to CMS for possible enforcement action.

⁴² 78 FR 68240 (Nov. 13, 2013).

⁴³ See, e.g., FAQs About Affordable Care Act Implementation Part V and Mental Health Parity Implementation (Dec. 22, 2010), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-v.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-5; FAQs About Affordable Care Act Implementation (Part VII) and Mental Health Parity Implementation (Nov. 17, 2011), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-vii.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-7; Understanding Implementation of the Mental Health Parity and Addiction Equity Act of 2008 (May 9, 2012), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/understanding-implementation-of-mhpaea.pdf; FAQs for Employees about the Mental Health Parity and Addiction Equity Act (May 18, 2012), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/mhpaea-2.pdf; FAQs About Affordable Care Act Implementation (Part XVII) and Mental Health Parity Implementation (Nov. 8, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xvii.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-17; FAQs About Affordable Care Act Implementation (Part XVIII) and Mental Health Parity Implementation (Jan. 9, 2014), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xviii.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-18; FAQs About Affordable Care Act Implementation (Part XXIX) and Mental Health Parity Implementation (Oct. 23, 2015), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxix.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-29 (FAQs Part XXIX); FAQs About Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and Women’s Health and Cancer Rights Act Implementation (Apr. 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-31; FAQs About Affordable Care Act Implementation Part 34 and Mental Health and Substance Use Disorder Parity Implementation (Oct. 27, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-34.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-34 (FAQs Part 34); FAQs About Mental Health and Substance Use Disorder Parity Implementation and the 21st Century Cures Act Part 38 (June 16, 2017), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-38.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-38 (FAQs Part 38); Proposed FAQs About Mental Health and Substance Use Disorder Parity Implementation and the 21st Century Cures Act Part 39, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-39-proposed.pdf (Proposed FAQs Part 39); Final FAQs About Mental Health and Substance Use Disorder Parity Implementation and the 21st Century Cures Act Part 39 (Sept. 5, 2019), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-39-final.pdf and https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-final-set-39 (FAQs Part 39); FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 43 (June 23, 2020), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf and https://www.hhs.gov/guidance/document/faqs-about-families-first-coronavirus-response-act-and-coronavirus-aid-relief-and-0 (FAQs part 43); FAQs About Mental Health and Substance Use Disorder Parity Implementation and the Consolidated Appropriations Act, 2021 Part 45 (Apr. 2, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-45.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/MHPAEA-FAQs-Part-45.pdf (FAQs Part 45); and Mental Health Parity and Addiction Equity Act (MHPAEA) FAQs, available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/mhpaea-1#.

⁴⁴ See, e.g., The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) Fact Sheet (Jan. 2010), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea.pdf; MHPAEA Enforcement Fact Sheet (Jan. 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement.pdf; FY 2016 MHPAEA Enforcement Fact Sheet, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2016.pdf; FY 2017 MHPAEA Enforcement Fact Sheet, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2017.pdf; FY 2018 MHPAEA Enforcement Fact Sheet, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2018.pdf; FY 2019 MHPAEA Enforcement Fact Sheet, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2019.pdf and https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/mhpaea-enforcement-2019.pdf; FY 2020 MHPAEA Enforcement Fact Sheet, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2020.pdf and https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/mhpaea-enforcement-2020.pdf; FY 2021 MHPAEA Enforcement Fact Sheet, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2021.pdf; and FY 2022 MHPAEA Enforcement Fact Sheet, available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2022.pdf.

⁴⁵ See Self-Compliance Tool for Part 7 of ERISA: Health Care-Related Provisions, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/compliance-assistance-guide-appendix-a.pdf; 2018 Self-Compliance Tool for the Mental Health Parity and Addiction Equity Act (MHPAEA), available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool-2018.pdf; and 2020 Self-Compliance Tool for the Mental Health Parity and Addiction Equity Act (MHPAEA), available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf.

⁴⁶ See Form to Request Documentation from an Employer-Sponsored Health Plan or a Group or Individual Market Insurer Concerning Treatment Limitations, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-disclosure-template.pdf.

⁴⁷ See, e.g., DOL 2012 Report to Congress: Compliance With the Mental Health Parity and Addiction Equity Act of 2008 (Jan. 1, 2012), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/mhpaea-report-to-congress-2012.pdf; DOL 2014 Report to Congress: Compliance of Group Health Plans (and Health Insurance Coverage Offered in Connection with Such Plans With the Requirements of the Mental Health Parity and Addiction Equity Act of 2008 (Sept. 2014), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/mhpaea-report-to-congress-2014.pdf; DOL 2016 Report to Congress: Improving Health Coverage for Mental Health and Substance Use Disorder Patients Including Compliance with the Federal Mental Health and Substance Use Disorder Parity Provisions (Jan. 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/improving-health-coverage-for-mental-health-and-substance-use-disorder-patients.pdf; HHS Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) Enforcement Report (Dec. 12, 2017), available at https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/HHS-2008-MHPAEA-Enforcement-Period.pdf; DOL 2018 Report to Congress: Pathway to Full Parity, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/dol-report-to-congress-2018-pathway-to-full-parity.pdf; 21st Century Cures Act: Section 13002 Action Plan for Enhanced Enforcement of Mental Health and Substance Use Disorder Coverage, available at https://www.hhs.gov/sites/default/files/parity-action-plan-b.pdf; HHS Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) Enforcement Report for the 2018 Federal Fiscal Year, available at https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/FY2018-MHPAEA-Enforcement-Report.pdf; DOL 2020 Report to Congress: Parity Partnerships: Working Together, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/dol-report-to-congress-parity-partnerships-working-together.pdf; 2022 Report to Congress: Realizing Parity, Reducing Stigma, and Raising Awareness, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf and https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf; MHPAEA Comparative Analysis Report to Congress, July 2023, available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf and https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity.

⁴⁸ See Consumer Guide to Disclosure Rights: Making the Most of Your Mental Health and Substance Use Disorder Benefits, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/disclosure-guide-making-the-most-of-your-mental-health-and-substance-use-disorder-benefits.pdf; Know Your Rights: Parity for Mental Health and Substance Use Disorder Benefits, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/know-your-rights-parity-for-mental-health-and-substance-use-disorder-benefits.pdf; Parity of Mental Health and Substance Use Benefits with Other Benefits: Using Your Employer-Sponsored Health Plan to Cover Services, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/parity-of-mental-health-and-substance-use-benefits-with-other-benefits.pdf; Understanding Parity: A Guide to Resources for Families and Caregivers, available at https://www.dol.gov/sites/dolgov/files/ebsa/laws-and-regulations/laws/mental-health-parity/understanding-parity-a-guide-to-resources-for-families-and-caregivers.pdf; Warning Signs – Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/warning-signs-plan-or-policy-nqtls-that-require-additional-analysis-to-determine-mhpaea-compliance.pdf; Mental Health Parity Provisions Questions and Answers, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/compliance-assistance-guide-mhpaea.pdf; Mental Health and Substance use Disorder Parity: Compliance Assistance Materials Index, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/compliance-assistance-materials-index.pdf; The Essential Aspects of Parity: A Training Tool for Policymakers, available at https://store.samhsa.gov/product/essential-aspects-of-parity-training-tool-for-policymakers/pep21-05-00-001; and Approaches in Implementing the Mental Health Parity and Addiction Equity Act: Best Practices from the States, available at https://store.samhsa.gov/product/Approaches-in-Implementing-the-Mental-Health-Parity-and-Addiction-Equity-Act-Best-Practices-from-the-States/SMA16-4983.

⁴⁹ The required classifications of benefits (and permissible sub-classifications) used to apply the MHPAEA regulations are addressed at 26 CFR 54.9812-1(c)(2)(ii), 29 CFR 2590.712(c)(2)(ii), and 45 CFR 146.136(c)(2)(ii).

⁵⁰ These proposed rules would apply directly to group health plans or health insurance coverage offered by an issuer in connection with a group health plan, and would apply to individual health insurance coverage by cross-reference through 45 CFR 147.160, which currently provides that the requirements of 45 CFR 146.136 apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner and to the same extent as to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the large group market. As noted below, HHS also proposes an amendment to 45 CFR 147.160 to also include a cross-reference to proposed 45 CFR 146.137 to similarly extend the new proposed comparative analysis requirements to individual health insurance coverage in the same manner and to the same extent as group health insurance coverage. For simplicity, this preamble generally refers only to the applicability on group health plans and health insurance coverage offered in connection with a group health plan and to participants and beneficiaries enrolled in such a plan or coverage, but references to participants and beneficiaries should also be considered to include enrollees in the individual market, unless otherwise specified.

⁵¹ Pub. L. 104–204, 110 Stat. 2874 (Sept. 26, 1996). The Departments published interim final rules implementing MHPA 1996 at 62 FR 66932 (Dec. 22, 1997).

⁵² The requirements of MHPAEA generally apply to both grandfathered and non-grandfathered health plans. See section 1251 of the Affordable Care Act and its implementing regulations at 26 CFR 54.9815-1251, 29 CFR 2590.715-1251, and 45 CFR 147.140. Under section 1251 of the Affordable Care Act, grandfathered health plans are exempted only from certain Affordable Care Act requirements enacted in Subtitles A and C of Title I of the Affordable Care Act. The provisions extending MHPAEA requirements to individual health insurance coverage and requiring that qualified health plans comply with MHPAEA are not included in these sections. However, because MHPAEA requirements apply to health insurance coverage offered in the small group market only through the requirement to provide EHB, which does not apply to grandfathered health plans, the requirements of MHPAEA do not apply to grandfathered health plans offered in the small group market.

⁵³ A QHP is a health insurance plan that is certified by a health insurance exchange that it meets certain minimum standards established under the Affordable Care Act and described in subpart C of 45 CFR part 156. See 45 CFR 155.20.

⁵⁴ Section 1302 of the Affordable Care Act requires non-grandfathered health plans in the individual and small group markets to cover essential health benefits (EHB), which include items and services in the following ten benefit categories: (1) ambulatory patient services; (2) emergency services; (3) hospitalization; (4) maternity and newborn care; (5) mental health and substance use disorder services including behavioral health treatment; (6) prescription drugs; (7) rehabilitative and habilitative services and devices; (8) laboratory services; (9) preventive and wellness services and chronic disease management; and (10) pediatric services, including oral and vision care. See 45 CFR 156.115 for description of the benefits a health plan must provide to provide EHB.

⁵⁵ Section 1302(b)(1)(E) of the Affordable Care Act; 45 CFR 156.115(a)(3).

⁵⁶ 74 FR 19155 (Apr. 28, 2009).

⁵⁷ 75 FR 5410 (Feb. 2, 2010).

⁵⁸ 78 FR 68240 (Nov. 13, 2013).

⁵⁹ Code section 9812(a)(3)(A), ERISA section 712(a)(3)(A), and PHS Act section 2726(a)(3)(A).

⁶⁰ With respect to aggregate lifetime and annual limits under MHPA 1996, the regulations in 26 CFR 54.9812-1(b); 29 CFR 2590.712(b), and 45 CFR 146.136(b) set forth rules based on whether a plan (or health insurance coverage) includes an aggregate lifetime or annual dollar limit that applies to less than one-third or at least two-thirds of all medical/surgical benefits. These provisions do not address the provisions of PHS Act section 2711, as incorporated by ERISA section 715 and Code section 9815, which prohibit imposing lifetime and annual limits on the dollar value of EHBs. As a result, plans and issuers cannot impose lifetime and annual dollar limits on mental health and substance use disorder benefits that are not EHBs, if such a limit applies to less than one-third of all medical/surgical benefits.

⁶¹ Code section 9812(a)(3)(A), ERISA section 712(a)(3)(A), and PHS Act section 2726(a)(3)(A).

⁶² 26 CFR 54.9812-1(c)(3)(v), 29 CFR 2590.712(c)(3)(v), 45 CFR 146.136(c)(3)(v) and 147.160.

⁶³ 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i), 45 CFR 146.136(c)(4)(i) and 147.160.

⁶⁴ 26 CFR 54.9812-1(d), 29 CFR 2590.712(d), 45 CFR 146.136(d) and 147.160.

⁶⁵ See FAQs Part 34, Q4-Q9.

⁶⁶ See FAQs Part 39, Q1-8.

⁶⁷ Section 13001(a) of the 21st Century Cures Act added section 2726(a)(6) of the PHS Act, which directs the Departments to provide a publicly available compliance program guidance document that is updated every 2 years.

⁶⁸ See Self-Compliance Tool for the Mental Health Parity and Addiction Equity Act (MHPAEA) (2020), available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf. The Departments issued the proposed 2020 MHPAEA Self-Compliance Tool on June 19, 2020, and requested comments from interested parties. Engagement with interested parties through written comments and listening sessions provided vital feedback for finalizing the 2020 update to the MHPAEA Self-Compliance Tool, and that final version includes revisions in response to that feedback.

⁶⁹ Id. at section F (at pp. 21-28).

⁷⁰ 2020 MHPAEA Self-Compliance Tool, at p. 21, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf.

⁷¹ Pub. L. 116-260, 134 Stat. 1182 (Dec. 27, 2020).

⁷² Code section 9812(a)(8)(A), ERISA section 712(a)(8)(A), and PHS Act section 2726(a)(8)(A).

⁷³ Id.

⁷⁴ Code section 9812(a)(8)(B)(i), ERISA section 712(a)(8)(B)(i), and PHS Act section 2726(a)(8)(B)(i).

⁷⁵ Code section 9812(a)(8)(A)(i)-(v), ERISA section 712(a)(8)(A)(i)-(v), and PHS Act section 2726(a)(8)(A)(i)-(v).

⁷⁶ Code section 9812(a)(8)(B)(ii), ERISA section 712(a)(8)(B)(ii), and PHS Act section 2726(a)(8)(B)(ii).

⁷⁷ Code section 9812(a)(8)(B)(iii)(I), ERISA section 712(a)(8)(B)(iii)(I), and PHS Act section 2726(a)(8)(B)(iii)(I).

⁷⁸ Id.

⁷⁹ Code section 9812(a)(8)(C)(iii), ERISA section 712(a)(8)(C)(iii), and PHS Act section 2726(a)(8)(C)(iii).

⁸⁰ Code section 9812(a)(8)(B)(iv), ERISA section 712(a)(8)(B)(iv), and PHS Act section 2726(a)(8)(B)(iv).

⁸¹ ERISA section 712(f).

⁸² Section 203 of the CAA, 2021 (Pub. L. 116-260, 134 Stat. 1182 (Dec. 27, 2020)). In addition, the Departments were required to send Congress an annual report on complaints and investigations concerning compliance with the requirements of MHPAEA from 2017 until 2021. See section 13003 of the 21st Century Cures Act (Cures Act), Pub. L. 114-255, 130 Stat. 1033 (Dec. 13, 2016), as amended by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub. L. 115-271, 132 Stat. 3894 (Oct. 24, 2018).

⁸³ 2022 MHPAEA Report to Congress, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf.

⁸⁴ 2023 MHPAEA Report to Congress, July 2023, available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf and https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity.

⁸⁵ Office of Consumer Information and Insurance Oversight, Amendments to the HIPAA opt-out provision (formerly section 2721(b)(2) of the Public Health Service Act) made by the Affordable Care Act (Sept. 21, 2010), available at www.cms.gov/CCIIO/Resources/Files/Downloads/opt_out_memo.pdf.

⁸⁶ 79 FR 15808 (Mar. 21, 2014).

⁸⁷ 79 FR 30240 (May 27, 2014).

⁸⁸ Pub. L. 117–328, 136 Stat. 4459.

⁸⁹ Division FF, Title I, Subtitle C, Chapter 3, sec. 1321, Pub. L. 117-328, 136 Stat. 4459. As a result of the CAA, 2023 amendments to PHS Act section 2722(a)(2), self-funded, non-Federal governmental plan sponsors may opt out of only the following three PHS Act requirement categories: Standards relating to benefits for newborns and mothers (PHS Act section 2725), Required coverage for reconstructive surgery following mastectomies (PHS Act section 2727), and Coverage for dependent students on a medically necessary leave of absence (PHS Act section 2728).

⁹⁰ PHS Act section 2722(a)(2)(F)(i).

⁹¹ PHS Act section 2722(a)(2)(F)(ii).

⁹² See 45 CFR 146.180(b) and (f).

⁹³ Center for Consumer Information and Insurance Oversight, Insurance Standards Bulletin Series – INFORMATION, Sunset of MHPAEA opt-out provision for self-funded, non-Federal governmental group health plans (June 7, 2023), available at https://www.cms.gov/files/document/hipaa-opt-out-bulletin.pdf.

⁹⁴ Non-grandfathered health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small group market is required to comply with the requirements under PHS Act section 2726 to satisfy the requirement to provide coverage for mental health and substance use disorder services, including behavioral health treatment, as part of EHB, and as such would also be required to comply with the comparative analysis requirements proposed under 45 CFR 146.137. See 45 CFR 156.115(a)(3).

⁹⁵ Division FF, Title I, Subtitle C, Chapter 3, sec. 1321, Pub. L. 117-328, 136 Stat. 4459 (Dec. 29. 2022).

⁹⁶ While the Departments recognize the relevant statutory text for dollar limits does not use the term “predominant” and different rules apply, the purpose of MHPA 1996 was similar and therefore the provisions for dollar limits should generally be read and applied in a similar manner. See, e.g., Government Accountability Office (GAO), Mental Health Parity Act, May 2000, at p. 13, available at https://www.gao.gov/assets/hehs-00-95.pdf (“To help address the discrepancies in coverage between mental and other illnesses, the Congress passed the Mental Health Parity Act of 1996.”).

⁹⁷ To accommodate the proposed addition of the “purpose” provision in paragraph (a)(1), these proposed rules would also redesignate the definitions from paragraph (a) to paragraph (a)(2) of 26 CFR 54.9812-1, 29 CFR 2590.712, and 45 CFR 146.136.

⁹⁸ Code section 9812(e)(3), ERISA section 712(e)(3), and PHS Act section 2726(e)(3).

⁹⁹ Id.

¹⁰⁰ See Code section 9812(e)(4)-(5), ERISA section 712(e)(4)-(5), and PHS Act section 2726(e)(4)-(5).

¹⁰¹ For example, some self-insured ERISA plans have argued that they can rely on State insurance law definitions that characterize a particular condition as a medical condition, mental health condition, or substance use disorder based on State guidelines despite the fact that State insurance law is generally not applicable to self-insured ERISA plans and such plans do not otherwise consistently comply with State insurance law.

¹⁰² Substance use disorders that fall under any of the diagnostic categories listed in the mental and behavioral health disorders chapter of the most current version of the ICD or that are listed in the most current version of the DSM would be excluded from the definition of the term “mental health benefits” because they would be included in the definition of the term “substance use disorder benefits.”

¹⁰³ Section 13007 of the Cures Act states that, if a plan or an issuer offering group or individual health insurance coverage provides coverage for eating disorder benefits, including residential treatment, such group health plan or health insurance issuer shall provide such benefits consistent with the requirements of MHPAEA.

¹⁰⁴ See, e.g., Diagnostic and Statistical Manual of Mental Disorders (5^th ed.), section II, Feeding and Eating Disorders; ICD-10, Chapter 05.

¹⁰⁵ The Departments previously clarified that eating disorders are mental health conditions, and therefore treatment of an eating disorder is a mental health benefit, in FAQs Part 38, Q1. See DSM (5th ed.), section II, Feeding and Eating Disorders.

¹⁰⁶ See DSM (5th ed.), section II, Autism Spectrum Disorder.

¹⁰⁷ See, e.g., Code section 9812(a)(8)(A), ERISA section 712(a)(8)(A), and PHS Act section 2726(a)(8)(A).

¹⁰⁸ Code section 9812(a)(7)(B)(ii)(II) and (8)(A)(iv), ERISA section 712(a)(7)(B)(ii)(II) and (8)(A)(iv), and PHS Act section 2726(a)(7)(B)(ii)(II) and (8)(A)(iv).

¹⁰⁹ See FAQs Part 31, Q9, which states that a plan must provide documents and plan information to a participant or beneficiary, or their authorized representative, including the specific underlying processes, strategies, evidentiary standards, and other factors (including, but not limited to, all evidence) considered by the plan (including factors that were relied upon and were rejected) in determining that the NQTL will apply to a particular mental health and substance use disorder benefit or any medical/surgical benefits within the benefit classification at issue.

¹¹⁰ Proposed 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i), and 45 CFR 146.136(c)(4)(i).

¹¹¹ Proposed 26 CFR 54.9812-1(c)(4)(ii), 29 CFR 2590.712(c)(4)(ii), and 45 CFR 146.136(c)(4)(ii).

¹¹² Proposed 26 CFR 54.9812-1(c)(4)(iv), 29 CFR 2590.712(c)(4)(iv), and 45 CFR 146.136(c)(4)(iv).

¹¹³ But see the special rule for NQTLs related to network composition at proposed 26 CFR 54.9812-1(c)(4)(iv)(C), 29 CFR 2590.712(c)(4)(iv)(C), and 45 CFR 146.136(c)(4)(iv)(C), which states that, when designing and applying one or more NQTLs related to network composition standards, a plan fails to meet the no more restrictive requirement and the design and application requirements, in operation, if the relevant data show material differences in access to in-network mental health and substance use disorder benefits as compared to in-network medical/surgical benefits in a classification.

¹¹⁴ The plan or issuer would also be required to document any steps taken in accordance with the material differences requirement (and the special rule for NQTLs related to network composition, if applicable) as part of its comparative analyses. Even if the plan or issuer had assessed compliance prior to the steps taken in accordance with the material differences requirement and the special rule for NQTLs related to network composition, the plan or issuer would be required to re-evaluate whether the no more restrictive requirement and the design and application requirements are met with respect to the adjusted NQTL.

¹¹⁵ Proposed 26 CFR 54.9812-1(c)(4)(ii)(B), 29 CFR 2590.712(c)(4)(ii)(B), and 45 CFR 146.136(c)(4)(ii)(B).

¹¹⁶ Proposed 26 CFR 54.9812-1(c)(4)(iv)(C), 29 CFR 2590.712(c)(4)(iv)(C), and 45 CFR 146.136(c)(4)(iv)(C).

¹¹⁷ Proposed 26 CFR 54.9812-1(c)(4)(vii), 29 CFR 2590.712(c)(4)(vii), and 45 CFR 146.136(c)(4)(vii).

¹¹⁸ As explained later in this preamble, the Departments are also proposing to add clarifying language to these proposed rules to make clear that any references to the term “classifications” in MHPAEA’s implementing regulations also includes permissible sub-classifications, including with respect to NQTLs.

¹¹⁹ See FAQs Part 34, Q3 (interpreting the reasonable method requirement with respect to financial requirements and quantitative treatment limits).

¹²⁰ 45 CFR 144.103 generally defines “product” as a discrete package of health insurance coverage benefits offered using a particular product network type within a service area, and “plan” as the pairing of the health insurance coverage benefits under the product with a particular cost-sharing structure, provider network, and service area. In this context, the term “plan” is not synonymous with the term “group health plan.” This approach would also apply to individual health insurance coverage under HHS regulations that incorporate the group market rules by reference.

¹²¹ The U.S. Qualification Standards apply to members of the six U.S.-based organizations who issue Statements of Actuarial Opinion in the United States. The organizations are the American Academy of Actuaries, American Society of Pension Professionals and Actuaries, American Society of Enrolled Actuaries, Casualty Actuarial Society, Conference of Consulting Actuaries, and Society of Actuaries.

¹²² Code section 9811, ERISA section 711, and PHS Act sections 2725 and 2751; 26 CFR 54.9811-1, 29 CFR 2590.711, and 45 CFR 146.130 and 148.170.

¹²³ The Departments note that the prohibition on discriminatory factors and evidentiary standards in proposed 26 CFR 54.49812-1(c)(4)(ii)(B), 29 CFR 2590.712(c)(4)(ii)(B), and 45 CFR 146.136(c)(4)(ii)(B) is not intended to affect the application of any other Federal or State laws for other purposes, and solicit comments on any potential interactions with other such laws that may warrant additional clarification.

¹²⁴ The Departments are also proposing to add the term “non-exhaustive” to cross-references to the illustrative, non-exhaustive list of NQTLs, contained in the definition of “treatment limitations” in 26 CFR 54.9812-1(a), 29 CFR 2590.712(a), and 45 CFR 146.136(a) and in the clarification of the term “type of financial requirement or treatment limitation” in 26 CFR 54.9812-1(c)(1)(ii), 29 CFR 2590.712(c)(1)(ii), and 45 CFR 146.136(c)(1)(ii).

¹²⁵ 26 CFR 54.9812-1(a), 29 CFR 2590.712(a), and 45 CFR 146.136(a) state that “[t]reatment limitations include.nonquantitative treatment limitations, which otherwise limit the scope or duration of benefits for treatment under a plan or coverage.”

¹²⁶ See, e.g., 2022 MHPAEA Report to Congress, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf and https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf.

¹²⁷ Self-Compliance Tool for the Mental Health Parity and Addiction Equity Act (MHPAEA) (2020), available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf.

¹²⁸ See NY Times, Insurers Alter Cost Formula, and Patients Pay More, available at https://www.nytimes.com/2012/04/24/nyregion/health-insurers-switch-baseline-for-out-of-network-charges.html; FairHealth, “Types of Out-of-Network Reimbursement,” available at https://www.fairhealthprovider.org/download/your-costs/Types%20of%20Out-of-Network%20Reimbursement.pdf

¹²⁹ 2020 MHPAEA Self-Compliance Tool; see FAQs Part 39, Q7.

¹³⁰ See Code section 9812(a)(8)(A)(iv), ERISA section 712(a)(8)(A)(iv), and PHS Act section 2726(a)(8)(A)(iv).

¹³¹ See FAQs Part 45, Q4.

¹³² Melek, S., Davenport, S., Gray, T. J. (2019). Addiction and mental health vs. physical health: Widening disparities in network use and provider reimbursement (p. 6). Milliman. https://assets.milliman.com/ektron/Addiction_and_mental_health_vs_physical_health_Widening_disparities_in_network_use_and_provider_reimbursement.pdf.

¹³³ Id.

¹³⁴ See, e.g., 2020 MHPAEA Self-Compliance Tool, Appendix II available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf; Washington State, Model Data Definitions and Methodology Form (used by Washington State for their Second Market Scan), available at http://www.mhtari.org/model-data-definitions-method.pdf; Maryland, Instructions for Completing Data Supplement 1 Report (Utilization Review) Form, available at https://insurance.maryland.gov/Consumer/Pages/workgroups.aspx.

¹³⁵ See White House Issue Brief, Reducing the Economic Burden of Unmet Mental Health Needs, available at https://www.whitehouse.gov/cea/written-materials/2022/05/31/reducing-the-economic-burden-of-unmet-mental-health-needs/ (acknowledging that provider shortages exist and 37% of the population live in areas with mental health practitioner shortages).

¹³⁶ The Technical Release was developed in collaboration with HHS and Treasury, and all comments submitted to DOL will be shared with them and posted on the EBSA website.

¹³⁷ Code section 9812(a)(3)(A), ERISA section 712(a)(3)(A), and PHS Act section 2726(a)(3)(A).

¹³⁸ Code section 9812(a)(8), ERISA section 712(a)(8), and PHS Act section 2726(a)(8).

¹³⁹ FAQs Part 39, Q6.

¹⁴⁰ See FAQs Part 34, Q8.

¹⁴¹ See FAQs Part 39, Q1.

¹⁴² 26 CFR 54.9831-1(c)(3)(vi)(B)(1), 29 CFR 2590.732(c)(3)(vi)(B)(1), and 45 CFR 146.145(b)(3)(vi)(B)(1); 79 FR 59130 (Oct. 1, 2014).

¹⁴³ See 26 CFR 54.9812-1(c)(4)(iii) Ex. 6, 29 CFR 2590.712(c)(4)(iii) Ex. 6, and 45 CFR 146.136(c)(4)(iii) Ex. 6. The Departments are proposing to renumber this example, and to add a clarification on interaction with the Departments’ group market excepted benefit rules, but otherwise propose to leave this example unamended.

¹⁴⁴ 78 FR 68240, 68246-7 (Nov. 13, 2013).

¹⁴⁵ The preamble to the 2013 final regulations stated, “For example, if a plan or issuer classifies care in skilled nursing facilities or rehabilitation hospitals as inpatient benefits, then the plan or issuer must likewise treat any covered care in residential treatment facilities for mental health or substance user disorders as an inpatient benefit. In addition, if a plan or issuer treats home health care as an outpatient benefit, then any covered intensive outpatient mental health or substance use disorder services and partial hospitalization must be considered outpatient benefits as well.” 78 FR 68240, 68247 (Nov. 13, 2013).

¹⁴⁶ 75 FR 5410, 5413 (Feb. 2, 2010).

¹⁴⁷ 26 CFR 54.9812-1(c)(3)(iii)(B), 29 CFR 2590.712(c)(3)(iii)(B), and 45 CFR 146.136(c)(3)(iii)(B).

¹⁴⁸ 26 CFR 54.9812-1(c)(3)(iii)(C), 29 CFR 2590.712(c)(3)(iii)(C), and 45 CFR 146.136(c)(3)(iii)(C).

¹⁴⁹ Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond, 86 FR 53412 (September 27, 2021), available at https://www.federalregister.gov/documents/2021/09/27/2021-20509/patient-protection-and-affordable-care-act-updating-payment-parameters-section-1332-waiver.

¹⁵⁰ Code section 9812(a)(8)(A), ERISA section 712(a)(8)(A), and PHS Act section 2726(a)(8)(A).

¹⁵¹ The contents of a corrective action plan will vary from one case to another, but such corrective action plans will generally be required to contain certain basic elements including: 1) identification of the noncompliant NQTL at issue, 2) proposed approaches to address this noncompliance, including strategies to provide relief to beneficiaries and participants who were adversely affected, 3) a timeline for implementation, 4) potential constraints or sources of delay that could adversely affect timely implementation, 5) points of contact for corrective action plan implementation, and 6) any other components deemed necessary by the Departments. When a plan or issuer submits a corrective action plan to the Departments, the plan shall be reviewed for completeness and sufficiency.

¹⁵² 78 FR 68239, 68250 (Nov. 13, 2013).

¹⁵³ Ibid.

¹⁵⁴ 2020 MHPAEA Self-Compliance Tool, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf.

¹⁵⁵ As noted earlier in this preamble, HHS enforces applicable provisions of Title XXVII of the PHS Act, including the provisions added by MHPAEA, with respect to health insurance issuers offering group and individual health insurance coverage in States that elect not to enforce or fail to substantially enforce MHPAEA or another PHS Act provision.

¹⁵⁶ The 2022 MHPAEA Report to Congress notes that EBSA has used the process outlined in section 203 of the CAA, 2021 as a method to engage with service providers (such as TPAs and MBHOs) to obtain wider-scope corrections affecting many plans at once, including pursuing cases against issuers in their capacity as administrative services-only providers (ASOs) to self-insured plans covered by ERISA.

¹⁵⁷ See FAQs Part 45, Q8 (listing prior authorization requirements for in-network and out-of-network inpatient services; concurrent review for in-network and out-of-network inpatient and outpatient services; standards for provider admission to participate in a network, including reimbursement rates; and out-of-network reimbursement rates (plan methods for determining usual, customary, and reasonable charges). Additionally, in the 2023 MHPAEA Report to Congress, EBSA added two areas of priority for the applicable Reporting Period based on CAA, 2021 implementation experience during the first reporting period: impermissible exclusions of key treatments for mental health conditions and substance use disorders and adequacy standards for mental health and substance use disorder provider networks.

¹⁵⁸ FAQs Part 45, Q8.

¹⁵⁹ Code section 9812(a)(8)(A)(iv), ERISA section 712(a)(8)(A)(iv), and PHS Act section 2726(a)(8)(A)(iv).

¹⁶⁰ 26 CFR 54.9812(c)(4)(i), 29 CFR 2590.712(c)(4)(i), and 45 CFR 146.136(c)(4)(i).

¹⁶¹ See State Parity Implementation Survey, available at https://www.paritytrack.org/reports/#state-disparities.

¹⁶² See, e.g., N.Y. Ins. Law 343(b); D.C. Code Sec. 31-3175.03; and Tex. Ins. Code Sec. 1355.254 (coverage for mental health conditions and substance use disorders).

¹⁶³ For examples of these State-imposed quantitative standards for assessing network adequacy, see https://www.ncsl.org/health/health-insurance-network-adequacy-requirements.

¹⁶⁴ 87 FR 27208 (May 6, 2022); 2023 Final Letter to Issuers in the Federally-facilitated Exchanges, available at https://www.cms.gov/sites/default/files/2022-04/Final-2023-Letter-to-Issuers_0.pdf.

¹⁶⁵ Code section 9812(a)(8)(A)(iv), ERISA section 712(a)(8)(A)(iv), and PHS Act section 2726(a)(8)(A)(iv).

¹⁶⁶ See, e.g., ERISA section 504.

⁶⁷ See FAQs Part XXIX, Q12.

¹⁶⁸ The “Six-Step” Parity Compliance Guide for Non-Quantitative Treatment Limitation (NQTL) Requirements, available at https://www.dol.gov/sites/dolgov/files/ebsa/laws-and-regulations/rules-and-regulations/public-comments/faq-38/00018.pdf.

¹⁶⁹ 26 CFR 54.9815-2715A1(a)(2)(xx), 29 CFR 2590.715-2715A1(a)(2)(xix), 45 CFR 147.210(a)(2)(xx).

¹⁷⁰ 29 CFR 2520.102-2(a).

¹⁷¹ See 26 CFR 54.9815-2715(a)(4)(ii)(B), 29 CFR 2590.715-2715(a)(4)(ii)(B), 45 CFR 147.200(a)(4)(ii)(B).

¹⁷² 26 CFR 54.9815-2719, 29 CFR 2590.715-2719, and 45 CFR 147.136.

¹⁷³ But see 26 CFR 54.9812-1(e)(4), 29 CFR 2590.712(e)(4), and 45 CFR 146.136(e)(4), which explains how these requirements interact with the requirement to provide EHBs under 45 CFR 147.150 and 156.115.

¹⁷⁴ Consistent with the statute, under these proposed rules, the comparative analysis requirements under proposed 26 CFR 54.9812-2, 29 CFR 2590.712-1, and 45 CFR 146.137 would not apply to a plan or issuer that qualifies for the small employer exemption under 26 CFR 54.9812-1(f), 29 CFR 2590.712(f), and 45 CFR 146.136(f) or the increased cost exemption under 26 CFR 54.9812-1(g), 29 CFR 2590.712(g), and 45 CFR 146.136(g).

¹⁷⁵ PHS Act section 2722(a)(2); 45 CFR 146.180.

¹⁷⁶ Division FF, Title I, Subtitle C, Chapter 3, sec. 1321, Pub. L. 117-328, 136 Stat. 4459 (Dec. 29, 2022).

¹⁷⁷ See Code section 4980D.

¹⁷⁸ 79 FR 14051 (March 12, 2014); FAQs about Affordable Care Act Implementation (Part XXVII) (May 26, 2015), Q4-5, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvii.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/ACA-FAQs-Part-XXVII-MOOP-2706-FINAL.pdf.

¹⁷⁹ See FAQs Part 43, Q14.

¹⁸⁰ Id.

¹⁸¹ See 26 CFR 54.9815-2719, 29 CFR 2590.715-2719, and 45 CFR 147.136. Grandfathered plans and issuers must also extend external review to adverse benefit determinations to items and services within the scope of the requirements for out-of-network emergency services, nonemergency services performed by nonparticipating providers with respect to patient visits to certain types of participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services under the No Surprises Act, including for denials related to compliance with such requirements. Such items and services may include mental health and substance use disorder services. See 26 CFR 54.9815-2719(a)(1)(ii), 29 CFR 2590.715-2719(a)(1)(ii), and 45 CFR 147.136(a)(1)(ii).

¹⁸² 26 CFR 54.9815-2719(b)(2)(ii)(C), 29 CFR 2590.715-2719(b)(2)(i) and (b)(2)(ii)(C), 45 CFR 147.136(b)(2)(i) and (b)(2)(ii)(C), and 29 CFR 2560.503-1(h)(2)(iii).

¹⁸³ 26 CFR 54.9812-1(d)(3), 29 CFR 2590.712(d)(3), and 45 CFR 146.136(d)(3).

¹⁸⁴ Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993).

¹⁸⁵ Improving Regulation and Regulatory Review, 76 FR 3821 (Jan. 18, 2011).

¹⁸⁶ 44 U.S.C. 3506(c)(2)(A) (1995).

¹⁸⁷ 5 U.S.C. 601 et seq. (1980).

¹⁸⁸ 2 U.S.C. 1501 et seq. (1995).

¹⁸⁹ Federalism, 64 FR 153 (Aug. 4, 1999).

¹⁹⁰ Executive Order 14094, 88 FR 21879 (Apr. 6, 2023).

¹⁹¹ Government Accountability Office. “Behavioral Health: Research on Health Care Costs of Untreated Conditions is Limited,” GAO-19-274, February 2019.

¹⁹² Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2021. Table 6.45B.

¹⁹³ Pasquini, Giancarlo, and Scott Keeter. Pews Research Center. “At Least Four-in-Ten US Adults Have Faced High Levels of Psychological Distress During COVID-19 Pandemic.” (2022).

¹⁹⁴ 78 FR 68240 (Nov. 13, 2013).

¹⁹⁵ Pub. L. 115-271, 132 Stat. 3894 (Oct. 24, 2018). The SUPPORT Act requires that Children’s Health Insurance Program (CHIP) plans must cover mental health and substance use disorder services. Financial requirements and treatment limitations applicable to such services shall not differ from those applicable to other medical services under CHIP.

¹⁹⁶ Available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf.

¹⁹⁷ 2023 MHPAEA Report to Congress, available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative- analysis.pdf.

¹⁹⁸ National Council for Mental Wellbeing. “2022 Access to Care Survey Results,” May 11, 2022. https://www.thenationalcouncil.org/wp-content/uploads/2022/05/2022-Access-To-Care-Survey-Results.pdf

¹⁹⁹ Health Affairs. “Combating a Crisis by Integrating Mental Health Services and Primary Care,” Health Affairs Forefront, July 8, 2022, available at https://www.healthaffairs.org/do/10.1377/forefront.20220706.603540.

²⁰⁰ Loeb, Danielle F., Elizabeth A. Bayliss, Ingrid A. Binswanger, Carey Candrian, and Frank V. Degruy. “Primary Care Physician Perceptions on Caring for Complex Patients with Medical and Mental Illness.” Journal of General Internal Medicine 27 (2012): 945-952. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3403152/; Poghosyan L, Norful AA, Ghaffari A, George M, Chhabra S, Olfson M. “Mental Health Delivery in Primary Care: The Perspectives of Primary Care Providers.” Archives of Psychiatric Nursing 2019 Oct; 33(5):63-67. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7077950/.

²⁰¹ Busch, Susan H., and Kelly Kyanko. “Assessment of Perceptions of Mental Health vs Medical Health Plan Networks Among US Adults with Private Insurance.” JAMA Network Open 4, no. 10 (2021).

²⁰² FAQs Part 45, Q6.

²⁰³ 2022 MHPAEA Report to Congress, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf.

²⁰⁴ 2023 MHPAEA Report to Congress, available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf.

²⁰⁵ Wen, Hefei, Janet R. Cummings, Jason M. Hockenberry, Laura M. Gaydos, and Benjamin G. Druss. “State Parity Laws and Access to Treatment for Substance Use Disorder in the United States: Implications for Federal Parity Legislation.” JAMA Psychiatry 70, no. 12 (2013): 1355-1362.

²⁰⁶ Employers with less than 50 employees are required to comply with MHPAEA as part of the EHB requirements of the ACA. The Departments estimate that there are 2,134,934 ERISA-covered group health plans with less than 50 participants based on data from the 2021 Medical Expenditure Panel Survey - Insurance Component and the 2019 County Business Patterns from the Census Bureau. The Departments also estimate that 83 percent of group health plans with less than 50 participants are fully insured based on data from the 2021 Medical Expenditure Panel Survey Insurance Component (MEPS-IC) and the 2019 County Business Patterns from the Census Bureau. The 2020 Kaiser Employer Health Benefits Survey reported that in 2020, 16 percent of firms offering health benefits offered at least one grandfathered health plan (Kaiser Employer Health Benefits Survey (Source: KFF. 2020 Kaiser Employer Health Benefits Survey. https://files.kff.org/attachment/Report-Employer-Health-Benefits-2020-Annual-Survey.pdf)). Thus, the Departments have calculated the number of fully insured, non-grandfathered plans with less than 50 participants in the following manner: 2,134,934 small ERISA-covered group health plans × 83% × (100% minus 16%) = 1,488,476. MHPAEA only applies to ERISA plans in the group market with 50 or more participants that offer mental health or substance use disorder benefits. The Departments have not identified what share of plans with 50 or more participants offer mental health or substance use disorder benefits and so has assumed that all of these plans offer them. Based on the 2021 MEPS-IC and the 2019 County Business Patterns from the Census Bureau, the Departments estimate 61 percent of ERISA-covered group health plans with 50 or more participants are self-insured. Thus, the Departments calculate the number of self-insured group health plans in the following manner: 409,822 ERISA-covered group health plans with 50 or more participants × 61% = 249,991.

²⁰⁷ Based on the 2017 Census of Governments, there are 90,126 State and local entities. The Departments assume there is one plan per entity on average. Therefore, the Departments estimate that there are 90,126 non-Federal governmental health plans.

²⁰⁸ MHPAEA applies to non-Federal governmental employers with 50 or more employees that offer mental health or substance use disorder benefits. The Departments have not identified what share of non-Federal governmental plans with 50 or more participants offer mental health or substance use disorder benefits and so have assumed that all of these plans offer them. Using data from the 2021 Medical Expenditure Panel Survey Insurance Component (MEPS-IC) and the 2019 County Business Patterns from the Census Bureau, the Departments estimates that 16 percent of ERISA-covered group health plans have 50 or more participants. The Departments use the percent of ERISA-covered group plans with 50 or more participants as a proxy for the percent of non-Federal governmental plans with 50 or more participants. Therefore, the Departments estimate that there are 14,420 public, non-Federal employer group health plans with 50 or more participants that offer mental health or substance use disorder benefits. (90,126 non-Federal governmental health plans × 16 percent of plans with 50 or more employees = 14,420).

²⁰⁹ Based on the HIPAA opt-out elections for self-funded, non-Federal governmental plans, as of January 6, 2023. Available at https://www.cms.gov/files/document/hipaaoptouts03182021.pdf.

²¹⁰ According to data from the Medical Expenditure Panel Survey – Insurance Component (2021) (available at: https://meps.ahrq.gov/mepsweb/https://meps.ahrq.gov/mepsweb/), there are 18,828,246 State and local government employees, and 69.1 percent of these employees (13,010,318) are enrolled in health coverage through their jobs. Of these employees, 64.4 percent (8,378,645 employees) are participants in self-funded plans. Based on data from the 2017 Census of Governments (available at: https://www.census.gov/data/tables/2017/econ/gus/2017-governments.html), there are 90,126 State and local government entities, and according to the Medical Expenditure Panel Survey (2021), 36.7 percent, or 33,076, of State and local government entities self-fund at least one plan. Therefore, the average number of participants per self-funded, non-Federal governmental plan is (8,378,645/33,076) = 253.3. Since HHS also estimates that there is 1 beneficiary for each plan participant on average, the average number of participants and beneficiaries per self-funded non-Federal governmental plan is (253.3 × 2) = 506.6.

²¹¹ 230 self-funded, non-Federal governmental plans that have elected to opt out of the requirements under MHPAEA × approximately 506.6 participants and beneficiaries for each self-funded, non-Federal governmental plan on average = 116,500.

²¹² Employers with 50 or more employees are required to comply with MHPAEA. Employers with less than 50 employees are required to comply with MHPAEA as part of the EHB requirements of the Affordable Care Act. The Departments have not identified what share of plans with 50 or more participants offer mental health or substance use disorder benefits and so has assumed that all of these plans offer them. The Departments estimate that there are 55,402,568 participants in ERISA-covered group health plans with 50 or more participants. Estimates are based off Department tabulations of the March 2021 Current Population Survey (CPS) Auxiliary Data. https://www.dol.gov/agencies/ebsa/researchers/data/auxiliary-data.

²¹³ MHPAEA only applies to non-Federal governmental health plans with 50 or more participants that offer mental health or substance use disorder benefits. The Departments have not identified what share of plans with 50 or more participants offer mental health or substance use disorder benefits and so has assumed that all of these plans offer them. The Departments estimate that there are 17,840,590 participants in non-Federal governmental health plans with 50 or more participants. Estimates are based on Department tabulations of the March 2021 CPS Auxiliary Data. https://www.dol.gov/agencies/ebsa/researchers/data/auxiliary-data.

²¹⁴ The Departments estimate that there are 26,311,273 participants and beneficiaries in fully insured, private-sector health plans with less than 50 participants based off Department tabulations of the March 2021 CPS Auxiliary Data. https://www.dol.gov/agencies/ebsa/researchers/data/auxiliary-data. Assuming, based on Kaiser Family Foundation (KFF) assumptions that 84 percent of participant and beneficiaries are in non-grandfathered plans (Source: KFF. 2020 KFF Employer Health Benefits Survey. https://files.kff.org/attachment/Report-Employer-Health-Benefits-2020-Annual-Survey.pdf), this would translate into an estimated 22,101,470 participants and beneficiaries in fully-insured, private-sector, non-grandfathered plans with less than 50 participants.

²¹⁵ Based on medical loss ratio reports submitted by issuers for the 2021 reporting year, the number of policyholders in individual health insurance coverage offered in the individual market is approximately 11 million. and the number of enrollees was approximately 15,000,000. https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.

²¹⁶ Gelburd, Robin. “The Mental Health Parity Act: 10 Years Later.” American Journal of Managed Care (Nov. 22, 2018). https://www.ajmc.com/view/the-mental-health-parity-act-10-years-later.

²¹⁷ Fronstin, Paul and Christopher Roebuck. “How Do High-Deductible Health Plans Affect Use of Health Care Services and Spending Among Enrollees with Mental Health Disorders?” EBRI Issue. No. 555, Figure 3. (March 10, 2022) Available at https://www.ebri.org/docs/default-source/ebri-issue-brief/ebri_ib_555_mentalhealth-10mar22.pdf?sfvrsn=aec3b2f_2.

²¹⁸ America’s Health Insurance Plans. “How Employer-Provided Coverage Improves Access to Mental Health Support,” May 2022. https://www.ahip.org/documents/202205-CaW_MentalHealth-v03.pdf.

²¹⁹ SAMHSA. “Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health.” pp. 39-40. https://www.samhsa.gov/data/sites/default/files/reports/rpt39443/2021NSDUHFFRRev010323.pdf

²²⁰ Panchal, Nirmita, Heather Saunders, Robin Rudowitz, and Cynthia Cox. “The Implications of COVID-19 for Mental Health and Substance Use,” KFF Issue Brief March 20, 2023. https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/.

²²¹ Taquet, Maxime, Sierra Luciano, John R. Geddes, and Paul J. Harrison. “Bidirectional Associations Between COVID-19 and Psychiatric Disorder: Retrospective Cohort Studies Of 62,354 COVID-19 Cases in the USA.” The Lancet Psychiatry 8, no. 2 (2021): 130-140.

²²² Xie, Yan, Evan Xu, and Ziyad Al-Aly. “Risks of Mental Health Outcomes in People with Covid-19: Cohort Study.” The BMJ 376 (2022), available at https://www.bmj.com/content/376/bmj-2021-068993.

²²³ Mazza, Mario Gennaro, Mariagrazia Palladini, Rebecca De Lorenzo, Beatrice Bravi, Sara Poletti, Roberto Furlan, Fabio Ciceri et al. “One-Year Mental Health Outcomes in a Cohort of COVID-19 Survivors.” Journal of Psychiatric Research 145 (2022): 118-124.

²²⁴ Warwicker, Sean, Denise Sant, Adrian Richard, Jake Cutajar, Annalise Bellizzi, Gertrude Micallef, Daniel Refalo, Liberato Camilleri, and Anton Grech. “A Retrospective Longitudinal Analysis of Mental Health Admissions: Measuring the Fallout of the Pandemic.” International Journal of Environmental Research and Public Health 20, no. 2 (2023): 1194.

²²⁵ The Departments’ estimate of the number of health insurance insurers and the number of issuer/State combinations is based on medical loss ratio reports submitted by issuers for the 2021 reporting year. (Source: Centers for Medicare & Medicaid Services. “Medical Loss Ratio Data and System Resources” (2021). https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.)

²²⁶ Non-issuer TPAs based on data derived from the 2016 benefit year reinsurance program contributions.

²²⁷ The Departments’ estimate of the number of insurers is based on industry trade association membership, including the National Behavioral Consortium (https://www.nbcgroup.org/member-directory/) and the Association for Behavioral Health and Wellness (https://abhw.org/about/). Please note that these estimates could undercount small State-regulated insurers.

²²⁸ KFF. “KFF Employer Health Benefits Survey, 2019.” (September 25, 2019) Table 14.15. See https://www.kff.org/report-section/ehbs-2019-section-14-employer-practices-and-health-plan-networks/.

²²⁹ Because many plans are exempt from filing a Form 5500, the Department only identified 37,934 self-insured health plan filings for 2020. Of these, only 5,537 plans (or roughly 15 percent) attached a Schedule C. Of those plans, 4,920 (or roughly 89 percent) indicated they paid compensation, either directly or indirectly, of at least $5,000 for either claims processing, contract administration, or both.

²³⁰ SAMHSA. “Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health.” Table 6.50B. The question does not distinguish between sources of insurance, available at https://www.samhsa.gov/data/sites/default/files/reports/rpt39443/2021NSDUHNNR122322/2021NSDUHNNR122322.htm.

²³¹ Zhu, Jane M., Yuehan Zhang, and Daniel Polsky. “Networks in ACA Marketplaces are Narrower for Mental Health Care than for Primary Care.” Health Affairs 36, no. 9 (September 2017): 1624-1631.

²³² Kaiser Family Foundation. “KFF Employer Benefits Survey, 2022.” (October 17, 2022) https://www.kff.org/report-section/ehbs-2022-summary-of-findings.

²³³ Zhu, Jane M., Christina J. Charlesworth, Daniel Polsky, and K. John McConnell. “Phantom Networks: Discrepancies Between Reported and Realized Mental Health Care Access in Oregon Medicaid.” Health Affairs 41, no. 7 (2022): 1013-1022.

²³⁴ See Ellison, Katherine, “73 Doctors and None Available: How Ghost Networks Hamper Mental Health Care.” The Washington Post (Feb. 19, 2022), available at https://www.washingtonpost.com/health/2022/02/19/mental-health-ghost-network/.

²³⁵ Busch, Susan H. and Kelly A. Kyanko. “Incorrect Provider Directories Associated with Out-of-Network Mental Health Care and Outpatient Surprise Bills.” Health Affairs, Vol. 39 No. 6 (June 2020): 975-083.

²³⁶ Wen, Hefei, Janet R. Cummings, Jason M. Hockenberry, Laura M. Gaydos, and Benjamin G. Druss. “State Parity Laws and Access to Treatment for Substance Use Disorder in the United States: Implications for Federal Parity Legislation.” JAMA Psychiatry 70, no. 12 (2013): 1355-1362.

²³⁷ Lang, Matthew. “The Impact of Mental Health Insurance Laws on State Suicide Rates.” Health Economics 22, no. 1 (2013).

²³⁸ Admon, Lindsay, Vanessa Dalton, Giselle Kolenic, Anca Tilea, Stephanie V. Hall, and Kara Zivin. “MHPAEA/ACA Policy Implementation and Severe Maternal Morbidity Among Commercially Insured Individuals, 2008–2019 [A192].” Obstetrics & Gynecology 139 (2022): 56S.

²³⁹ Ohrnberger, Julius, Eleonora Fichera, and Matt Sutton. “The Relationship between Physical and Mental Health: A Mediation Analysis.” Social Science & Medicine 195 (2017): 42-49.

²⁴⁰ SAMHSA. “Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health.” Figure 65.

²⁴¹ SAMHSA. “Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health.” Figure 54 and 57.

²⁴² National Council for Mental Wellbeing. “2022 Access to Care Survey Results,” May 11, 2022. https://www.thenationalcouncil.org/wp-content/uploads/2022/05/2022-Access-To-Care-Survey-Results.pdf.

²⁴³ Greenberg, Paul E., Andree-Anne Fournier, Tammy Sisitsky, Mark Simes, Richard Berman, Sarah H. Koenigsberg, and Ronald C. Kessler. “The Economic Burden of Adults with Major Depressive Disorder in the United States (2010 and 2018).” Pharmacoeconomics 39, no. 6 (2021): 653-665.

²⁴⁴ Lund, Crick, Kate Orkin, Marc Witte, Thandi Davies, John Walker, Johannes Haushofer, Sarah Murray, Judy Bass, Laura Murray, and Vikram Patel. “Treating Mental Health Conditions Improves Labor Market and Other Economic Outcomes in Low and Middle-Income Countries.” University of Oxford, Working Paper (2022).

²⁴⁵ Andersen, Martin. “Heterogeneity and the Effect of Mental Health Parity Mandates on the Labor Market.” Journal of Health Economics 43 (2015).

²⁴⁶ Margiotta, Caroline, Jessica Gao, So O’Neil, Divya Vohra and Kara Zivin. “The Economic Impact of Untreated Maternal Mental Health Conditions in Texas.” BMC Pregnancy Childbirth 22, 700 (2022). https://doi.org/10.1186/s12884-022-05001-6.

²⁴⁷ Platt, Isabel, Emma Pendl-Robinson, Eric Dehus, So O’Neil, Divya Vohra, Kara Zivin, Michael Kenny and Laura Pentenrieder. “Estimating the Costs of Untreated Perinatal Mood and Anxiety Disorders in Vermont.” Mathematica. May 2023. https://www.mathematica.org/publications/societal-costs-of-perinatal-mood-and-anxiety-disorders-in-vermont.

²⁴⁸ Witters, Dan and Sangeeta Agrawal. “The Economic Cost of Poor Employee Mental Health” Gallup Workplace (December 13, 2022). https://www.gallup.com/workplace/404174/economic-cost-poor-employee-mental-health.aspx?version=print.

²⁴⁹ Lee, Donghoon, Yeonil Kim, and Beth Devine. “Spillover Effects of Mental Health Disorders on Family Members’ Health-related Quality of Life: Evidence from a US Sample.” Medical Decision Making 42, no. 1 (2022): 80-93.

²⁵⁰ Florence, Curtis, Feijun Luo, and Ketra Rice. “The Economic Burden of Opioid Use Disorder and Fatal Opioid Overdose in the United States, 2017.” Drug and Alcohol Dependence 218 (2021): 108350.

²⁵¹ Mulvaney-Day, Norah, Brent J. Gibbons, Shums Alikhan, and Mustafa Karakus. “Mental Health Parity and Addiction Equity Act and the Use of Outpatient Behavioral Health services in the United States, 2005–2016.” American Journal of Public Health 109, no. S3 (2019): S190-S196.

²⁵² Li, Xiaoxue, and Jie Ma. “Does Mental Health Parity Encourage Mental Health Utilization Among Children and Adolescents? Evidence From The 2008 Mental Health Parity and Addiction Equity Act (MHPAEA).” The Journal of Behavioral Health Services & Research 47, no. 1 (2020): 38-53.

²⁵³ Leung, Lucinda B., Lisa V. Rubenstein, Jean Yoon, Edward P. Post, Erin Jaske, Kenneth B. Wells, and Ranak B. Trivedi. “Veterans Health Administration Investments in Primary Care and Mental Health Integration Improved Care Access.” Health Affairs 38, no. 8 (2019): 1281-1288.

²⁵⁴ Hughes, M. Courtney, Jack M. Gorman, Yingqian Ren, Sana Khalid, and Carol Clayton. “Increasing Access to Rural Mental Health Care Using Hybrid Care that Includes Telepsychiatry.” Journal of Rural Mental Health 43, no. 1 (2019): 30.

²⁵⁵ Horgan, Constance M., Dominic Hodgkin, Maureen T. Stewart, Amity Quinn, Elizabeth L. Merrick, Sharon Reif, Deborah W. Garnick, and Timothy B. Creedon. “Health Plans’ Early Response to Federal Parity Legislation for Mental Health and Addiction Services.” Psychiatric Services 67, no. 2 (2016): 162-168.

²⁵⁶ A labor rate of $132.38 is used for a general or operations manager and a labor rate of $109.96 is used for a business operations specialist. (Source: Estimates for total compensation are based on mean hourly wages by occupation from the 2021 Occupational Employment Statistics and estimates of wages and salaries as a percentage of total compensation by occupation are from the December 2021 National Compensation Survey’s Employee Cost for Employee Compensation. Estimates for overhead costs for services are imputed from the 2020 Service Annual Survey. To obtain overhead cost on an occupational basis, the estimate allocates total industry overhead cost to unique occupations using a matrix of detailed occupational employment for each NAICS industry. All values are in 2023 dollars.) The labor rate is applied in the calculation as: [(27,499 ERISA self-insured group health plans × 4 NQTLs × 2 hours × $132.38 for a general or operations manager) + (27,499 ERISA self-insured group health plans × 4 NQTLs × 8 hours × $109.96 for a business operations specialist) + (1,500 issuers × 8 NQTLs × 2 hours × $132.38 for a general or operations manager) + (1,500 issuers × 8 NQTLs × 8 hours × $109.96 for a general or operations manager) + (33,076 self-funded, non-Federal governmental health plans × 4 NQTLs × 2 hours × $132.38 for a general or operations manager) + (33,076 self-funded, non-Federal governmental health plans × 4 NQTLs × 2 hours × $109.96 for a business operations specialist)] = $291,031,092.

²⁵⁷ A labor rate of $132.38 is used for a general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rate is applied in the calculation as: [(27,499 ERISA self-insured group health plans × 4 NQTLs × 1 hour × $132.38 for a general or operations manager) + (27,499 ERISA self-insured group health plans × 4 NQTLs × 3 hours × $109.96 for a business operations specialist) + (1,500 × 8 NQTLs × 1 hour × $132.38 for a general or operations manager) + (1,500 issuers × 8 NQTLs × 3 hours × $109.96 for a general or operations manager) + (33,076 self-funded, non-Federal governmental health plans × 4 NQTLs × 1 hours × $132.38 for a general or operations manager) + (33,076 self-funded, non-Federal governmental health plans × 4 NQTLs × 3 hours × $109.96 for a business operations specialist)] = $117,552,718.

²⁵⁸ The Departments estimate that there are 476 issuers with 1,500 issuer/State combinations offering individual and group health coverage nationwide. A labor rate of $63.45 is used for a clerical worker. The labor rate is applied in the calculation as: (1,898,298 ERISA group health plans + 90,126 non-Federal governmental health plans + 1,500 issuers/State combinations providing coverage in the group and individual market) × 5 minutes × $63.45 = $10,521,787.

²⁵⁹ According to data from the National Telecommunications and Information Agency (NTIA), 40.0 percent of individuals aged 25 and over have access to the Internet at work. According to a Greenwald & Associates survey, 84 percent of plan participants find it acceptable to make electronic delivery the default option, which is used as the proxy for the number of participants who will not opt-out of electronic disclosure that are automatically enrolled (for a total of 33.6 percent receiving electronic disclosure at work). Additionally, the NTIA reports that 40.4 percent of individuals aged 25 and over have access to the internet outside of work. According to a Pew Research Center survey, 61.0 percent of internet users use online banking, which is used as the proxy for the number of internet users who will affirmatively consent to receiving electronic disclosures (for a total of 24.7 percent receiving electronic disclosure outside of work). Combining the 33.6 percent who have access to electronic disclosure at work with the 24.7 percent who have access to electronic disclosure outside of work produces a total of 58.2 percent who will receive to electronic disclosure overall.

²⁶⁰ The Departments assume one request per entity and that each mailed response will cost $1.89 in materials and postage, on average. The mailing and postage cost assume $.05 per printed page, an average document length of 15 pages and $1.14 in postage for a 3-ounce parcel. Therefore, the cost is estimated as (1,488,476 fully-insured, non-grandfathered plans with less than 50 participants + 409,822 ERISA-covered group health plans with 50 or more participants + 1,500 issuers/State Combinations + 90,126 non-Federal governmental health plans) × 41.8% × ($1.14 + (15 pages × $0.05)) = $1,572,080.

²⁶¹ A labor rate of $159.34 is used for an attorney (this figure reflects the median hourly wage of lawyers according to the DOL Bureau of Labor Statistics Occupational Employment and Wage Statistics for May 2022, doubled to account for overhead costs and benefits). The reading time is calculated based on an average 250 words per minute reading rate. The labor rate is applied in the calculation as: (27,499 self-funded, ERISA group health plans + 33,076 self-funded, non-Federal governmental health plans + 1,500 issuers/State combinations providing coverage in the group and individual market) × 6.5 hours × $159.34 = $64,291,778.

²⁶² Centers for Medicare and Medicaid Services. “National Health Expenditure Data.” NHE Tables - Table 24. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/nationalhealthaccountshistorical.

²⁶³ Centers for Medicare and Medicaid Services. “National Health Expenditure Data.” NHE Tables - Table 21. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/nationalhealthaccountshistorical.

²⁶⁴ The cost is estimated as follows: $291.0 million for preparing the comparative analyses + $64.3 million for reviewing the proposed rules and amendments + $10.5 million to prepare the comparative analyses upon request to participants and beneficiaries + $1.6 million to distribute the comparative analyses to participants and beneficiaries = $367.4 million.

²⁶⁵ The cost is estimated as follows: $117.6 million for preparing the comparative analyses + $10.5 million for preparing the comparative analyses upon request to participants and beneficiaries + $1.6 million to distribute the comparative analyses to participants and beneficiaries = $129.6 million.

²⁶⁶ Busch, Alisa B., Frank Yoon, Colleen L. Barry, Vanessa Azzone, Sharon-Lise T. Normand, Howard H. Goldman, and Haiden A. Huskamp. “The Effects of Parity on Mental Health and Substance Use Disorder Spending and Utilization: Does Diagnosis Matter?” The American Journal of Psychiatry 170, no. 2 (2013): 180.

²⁶⁷ Kennedy-Hendricks, Alene, Andrew J. Epstein, Elizabeth A. Stuart, Rebecca L. Haffajee, Emma E. McGinty, Alisa B. Busch, Haiden A. Huskamp, and Colleen L. Barry. “Federal Parity and Spending for Mental Illness.” Pediatrics 142, no. 2 (2018).

²⁶⁸ Haffajee, Rebecca L., Michelle M. Mello, Fang Zhang, Alisa B. Busch, Alan M. Zaslavsky, and J. Frank Wharam. “Association Of Federal Mental Health Parity Legislation with Health Care Use and Spending Among High Utilizers of Services.” Medical Care 57, no. 4 (2019): 245.

²⁶⁹ Congressional Budget Office. Congressional Budget Office Cost Estimate: S558. March 20, 2007. https://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/78xx/doc7894/s558.pdf.

²⁷⁰ Melek, Steve. “The Cost of Mental Health Parity.” Health Section News. Issue 49. (2005) As presented to the Society of Actuaries. https://www.soa.org/globalassets/assets/library/newsletters/health-section-news/2005/march/hsn-2005-iss49-melek-b.pdf.

²⁷¹ McConnell, K. John, Samuel HN Gast, and Bentson H. McFarland. “The Effect of Comprehensive Behavioral Health Parity on Choice of Provider.” Medical Care 50, no. 6 (2012): 527.

²⁷² 2022 MHPAEA Report to Congress, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf.

²⁷³ Government Accountability Office. “Mental Health and Substance Use: Employers’ Insurance Coverage Maintained or Enhanced Since Parity Act, but Effect of Coverage on Enrollees Varied,” GAO-12-63, November 2011.

²⁷⁴ Popovici, Ioana, Johanna Catherine Maclean, and Michael T. French (2017). “The Effects of Health Insurance Parity Laws for Substance Use Disorder Treatment on Traffic Fatalities: Evidence of Unintended Benefits.” National Bureau of Economic Research. https://www.nber.org/system/files/working_papers/w23388/revisions/w23388.rev0.pdf?sy=388

²⁷⁵ Sharma, Keshob. “Do Mental Health Parity Laws Reduce Crime?” (2021).

²⁷⁶ 44 U.S.C. 3506(c)(2)(A) (1995).

²⁷⁷ MHPAEA only applies to ERISA plans in the group market with 50 or more participants that offer mental health or substance use disorder (MH/SUD) benefits. The Departments have not identified what share of plans with 50 or more participants offer MH/SUD benefits and has therefore assumed that all of these plans offer them. Based on the 2021 Medical Expenditure Survey, 61 percent of ERISA-covered group health plans with 50 or more participants are self-insuring. Thus, the Department calculates the number of ERISA self-insured group health plans with 50 or more participants based on the following manner: 409,822 ERISA group health plans with 50 or more participants × 61% = 249,991.

²⁷⁸ Because many plans are exempt from filing a Form 5500, the Department only identified 37,934 self-insured health plan filings for 2020. Of these, only 5,537 plans (or roughly 15 percent) attached a Schedule C. Of those plans, 4,920 (or roughly 89 percent) indicated they paid compensation, either directly or indirectly, of at least $5,000 for either claims processing, contract administration, or both.

²⁷⁹ Based on the 2020 Form 5500, 89 percent of self-insured plans filed a Schedule C and indicated using either a Claims Processor, Contract Administrator, or both.

²⁸⁰ The Departments assume only large plans, defined as a plan with 50 or more participants would self-administer. 249,991 self-funded ERISA plans with 50 or more participants × 11 percent of plans that self-administer = 27,499.

²⁸¹ It should be emphasized, however, that DOL currently relies on supplemental appropriations passed as part of CAA, 2021, to fund these enforcement efforts. The supplemental appropriations are currently scheduled to expire at the end of FY 2024 with the consequence that DOL would lose funds for between a quarter and a third of its enforcement program and EBSA would have to commensurately reduce its staff size by approximately 120 full-time employees (FTEs). As a result, its MHPAEA enforcement efforts would necessarily decline, and the estimates of associated expenses would correspondingly decline.

²⁸² The burden is calculated as follows: (100 ERISA self-insured group health plans × 1 hour for a general or operations manager) + (100 ERISA self-insured group health plans × 4 hours for a business operations specialist) = 500 hours. A labor rate of $132.38 is used for a general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rate is applied in the calculation as: (100 ERISA self-insured group health plans × 1 hour for a general or operations manager × $132.38) + (100 ERISA self-insured group health plans × 4 hours for a business operations specialist × $109.96) = $57,222

²⁸³ The estimated hour burden is consistent with the hour burden estimated in the previous PRA supporting statement for 1210-0138. In the PRA supporting statement, the Departments estimated that it would take a total of 20 hours for plans to update each comparative analysis as required by the CAA, 2021 (https://omb.report/icr/202108-1210-015/doc/114767500). This estimate differs by accounting for plans needing to evaluate multiple NQTLs.

²⁸⁴ The burden is calculated as follows: (27,499 ERISA self-insured group health plans × 4 NQTLs × 4 hours for a general or operations manager) + (27,499 ERISA self-insured group health plans × 4 NQTLs × 16 hours for a business operations specialist) = 2,199,921 hours. A labor rate of $132.38 is used for a general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rate is applied in the calculation as: (27,499 ERISA self-insured group health plans × 4 NQTLs × 4 hours for a general or operations manager × $132.38) + (27,499 ERISA self-insured group health plans × 4 NQTLs × 16 hours for a business operations specialist × $109.96) = $251,767,736. DOL estimates of labor costs by occupation reflect estimates of total compensation and overhead costs. Estimates for total compensation are based on mean hourly wages by occupation from the 2021 Occupational Employment Statistics and estimates of wages and salaries as a percentage of total compensation by occupation from the December 2021 National Compensation Survey’s Employee Cost for Employee Compensation. Estimates for overhead costs for services are imputed from the 2020 Service Annual Survey. To obtain overhead cost on an occupational basis, the estimate allocates total industry overhead cost to unique occupations using a matrix of detailed occupational employment for each NAICS industry. All values are in 2023 dollars.

²⁸⁵ The burden is calculated as follows: (27,499 ERISA self-insured group health plans × 4 NQTLs × 2 hours for a general or operations manager) + (27,499 ERISA self-insured group health plans × 4 NQTLs × 8 hours for a business operations specialist) = 1,099,960 hours. A labor rate of $132.38 is used for a general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rate is applied in the calculation as: (27,499 ERISA self-insured group health plans × 4 NQTLs × 2 hours for a general or operations manager × $132.38) + (27,499 ERISA self-insured group health plans × 4 NQTLs × 8 hours for a business operations specialist × $109.96) = $125,883,822.

²⁸⁶ The hour burden is estimated as: (1,488,476 fully-insured, non-grandfathered plans with less than 50 participants + 409,822 ERISA-covered group health plans with 50 or more participants) × 5 minutes = 158,192 hours. A labor rate of $63.45 is used for a clerical worker. The labor rate is applied in the calculation as: (1,488,476 fully-insured, non-grandfathered plans with less than 50 participants + 409,822 ERISA-covered group health plans with 50 or more participants) × 5 minutes × $63.45 = $10,037,282.

²⁸⁷ According to data from the National Telecommunications and Information Agency (NTIA), 40.0 percent of individuals age 25 and over have access to the Internet at work. According to a Greenwald & Associates survey, 84 percent of plan participants find it acceptable to make electronic delivery the default option, which is used as the proxy for the number of participants who will not opt out of electronic disclosure that are automatically enrolled (for a total of 33.6 percent receiving electronic disclosure at work). Additionally, the NTIA reports that 40.4 percent of individuals age 25 and over have access to the internet outside of work. According to a Pew Research Center survey, 61.0 percent of internet users use online banking, which is used as the proxy for the number of internet users who will affirmatively consent to receiving electronic disclosures (for a total of 24.7 percent receiving electronic disclosure outside of work). Combining the 33.6 percent who receive electronic disclosure at work with the 24.7 percent who receive electronic disclosure outside of work produces a total of 58.2 percent who will receive electronic disclosure overall.

²⁸⁸ The Departments assume one request per entity and that each mailed response will cost $1.89 in materials and postage, on average. The mailing and postage cost assume $.05 per printed page, an average document length of 15 pages and $1.14 in postage for a 3-ounce parcel. Therefore, the cost burden is calculated as follows: (1,488,476 fully-insured, non-grandfathered plans with less than 50 participants + 409,822 ERISA-covered group health plans with 50 or more participants) × 41.8% × ($1.14 + (15 pages × $0.05)) = $1,499,693.

²⁸⁹ The hour burden is estimated as: (1,488,476 fully-insured, non-grandfathered plans with less than 50 participants + 409,822 ERISA-covered group health plans with 50 or more participants) × 5 minutes = 158,192 hours. A labor rate of $63.45 is used for a clerical worker. The labor rate is applied in the calculation as: (1,488,476 fully-insured, non-grandfathered plans with less than 50 participants + 409,822 ERISA-covered group health plans with 50 or more participants) × 5 minutes × $63.45 = $10,037,282.

²⁹⁰ 44 U.S.C. 3506(c)(2)(A) (1995).

²⁹¹ The burden is calculated as follows: (20 plans and issuers × 1 hour for a general or operations manager) + (20 plans and issuers × 4 hours for a business operations specialist) = 100 hours. A labor rate of $132.38 is used for a general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rate is applied in the calculation as: (20 plans and issuers × 1 hour for a general or operations manager × $132.38) + (20 plans and issuers × 4 hours for a business operations specialist × $109.96) = $11,444.

²⁹² The burden is estimated as follows: (1,500 issuers × 8 NQTLs × 4 hours for a general or operations manager) + (1,500 issuers × 8 NQTLs × 16 hours for a business operations specialist) = 240,000 hours. A labor rate of $132.38 is used for general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rates are applied in the calculation as: (1,500 issuers × 8 NQTLs × 4 hours for a general or operations manager × $132.38) + (1,500 issuers × 8 NQTLs × 16 hours for a business operations specialist × $109.96) = $27,466,560.

²⁹³ The burden is estimated as follows: (1,500 issuers × 8 NQTLs × 2 hours for a general or operations manager) + (1,500 issuers × 8 NQTLs × 8 hours for a business operations specialist) = 120,000 hours. A labor rate of $132.38 is used for general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rates are applied in the calculation as: (1,500 issuers × 8 NQTLs × 2 hours for a general or operations manager × $132.38) + (1,500 issuers × 8 NQTLs × 2 hours for a business operations specialist × $109.96) = $13,733,280.

²⁹⁴ Based on the 2017 Census of Governments, there are 90,126 non-Federal governmental health plans. Based on the 2021 Medical Expenditure Panel Survey, the Department estimates that 36.7 percent of non-Federal governmental health plans are self-funded. Thus, 90,126 plans × 36.7 percent = 33,076 self-funded, non-Federal governmental health plans.

²⁹⁵ The burden is estimated as follows: (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 4 hours for a general or operations manager) + (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 16 hours for a business operations specialist) = 2,646,080 hours. A labor rate of $132.38 is used for general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rates are applied in the calculation as: (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 4 hours for a general or operations manager × $132.38) + (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 16 hours for a business operations specialist × $109.96) = $302,827,980.

²⁹⁶ The burden is estimated as follows: (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 2 hours for a general or operations manager) + (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 8 hours for a business operations specialist) = 1,323,040 hours. A labor rate of $132.38 is used for general or operations manager and a labor rate of $109.96 is used for a business operations specialist. The labor rates are applied in the calculation as: (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 2 hours for a general or operations manager × $132.38) + (33,076 self-funded non-Federal governmental plans × 4 NQTLs × 8 hours for a business operations specialist × $109.96) = $151,413,990.

²⁹⁷ The hour burden is calculated as (90,126 non-Federal governmental plans + 1,500 issuer/State combinations) × 5 minutes = 7,636 hours. A labor rate of $63.45 is used for a clerical worker. The labor rate is applied in the calculation as: (90,126 non-Federal governmental plans + 1,500 issuer/State combinations) × 5 minutes × $63.45 = $484,504.

²⁹⁸ According to data from the National Telecommunications and Information Agency (NTIA), 40.0 percent of individuals age 25 and over have access to the Internet at work. According to a Greenwald & Associates survey, 84 percent of plan participants find it acceptable to make electronic delivery the default option, which is used as the proxy for the number of participants who will not opt-out of electronic disclosure that are automatically enrolled (for a total of 33.6 percent receiving electronic disclosure at work). Additionally, the NTIA reports that 40.4 percent of individuals age 25 and over have access to the internet outside of work. According to a Pew Research Center survey, 61.0 percent of internet users use online banking, which is used as the proxy or the number of internet users who will affirmatively consent to receiving electronic disclosures (for a total of 24.7 percent receiving electronic disclosure outside of work). Combining the 33.6 percent who receive electronic disclosure at work with the 24.7 percent who receive electronic disclosure outside of work produces a total of 58.2 percent who will receive electronic disclosure overall.

²⁹⁹ The Departments assume one request per entity and that each mailed response will cost $1.89 in materials and postage, on average. The mailing and postage cost assume $.05 per printed page, an average document length of 15 pages and $1.14 in postage for a 3-ounce parcel. Therefore, the cost burden is calculated as follows: (1,500 issuers + 90,126 non-Federal governmental health plans) × 41.8% × ($1.14 + (15 pages × $0.05)) = $72,386.

³⁰⁰ The hour burden is calculated as (90,126 non-Federal governmental plans + 1,500 issuer/State combinations) × 5 minutes = 7,636 hours. A labor rate of $63.45 is used for a clerical worker. The labor rate is applied in the calculation as: (90,126 non-Federal governmental plans + 1,500 issuer/State combinations) × 5 minutes × $63.45 = $484,504.

³⁰¹ CMS-10773, “Non-Quantitative Treatment Limitation Analyses and Compliance Under MHPAEA.”

³⁰² Based on the HIPAA opt-out filings, sponsors of 46 self-funded, non-Federal governmental plans permissibly opt out of other requirements (standards relating to benefits for mothers and newborns, required coverage for reconstructive surgery following mastectomies, and/or coverage of dependent students on medically necessary leave of absence).

³⁰³ This includes the time required by the individual signing the certification to conduct a thorough review of the election contents.

³⁰⁴ The total annual burden reduction is calculated as: 185 plans × 15 minutes = 46 hours. A labor rate of $137.64 is used for a compensation and benefits manager. The labor rate is applied in the calculation as: 185 plans × 15 minutes × $137.64 = $6,331.

³⁰⁵ See Office of Personnel Management 2023 General Schedule (GS) Locality Pay Tables, available at: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2023/DCB_h.pdf.

³⁰⁶ The total annual burden reduction for the Federal government is calculated as: 185 plans × 15 minutes = 46 hours. A labor rate of $53.67 is used for an HHS employee. The labor rate is applied in the calculation as: 185 plans × 15 minutes × $53.67 = $2,469.

³⁰⁷ The total annual burden reduction is calculated as: 185 plans × 15 minutes = 46 hours. A labor rate of $41.74 is used for an administrative assistant. The labor rate is applied in the calculation as: 185 plans × 15 minutes × $41.74 = $1,920.

³⁰⁸ 185 plans × slightly more than 253 participants per plan on average ≈ 46,863 notices in total.

³⁰⁹ The total cost savings is calculated as: 46,863 notices × $0.05 = $2,343.

³¹⁰ CMS-10430, “Information Collection Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health Service Act.”

³¹¹ 5 U.S.C. 601 et seq. (1980).

³¹² 5 U.S.C. 551 et seq. (1946).

³¹³ 2022 MHPAEA Report to Congress, available at https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf; 2023 MHPAEA Report to Congress, available at www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf.

³¹⁴ The Departments estimate that there are 152,254 ERISA-covered group health plans with 50 to 100 participants based on the 2021 Medical Expenditure Survey - Insurance Component (MEPS-IC) and the 2019 County Business Patterns from the Census Bureau. The Departments also estimate that 75 percent of ERISA-covered group health plans with 50 to 100 participants are fully insured based on assumptions referencing this same data. Thus, the Departments have calculated the number of fully insured plans with 50 to 100 participants in the following manner: 152,254 ERISA-covered group health plans with 50 to 100 participants × 75% = 114,191.

³¹⁵ Employers with less than 50 employees are required to comply with MHPAEA as part of the Essential Health Benefits requirements. The Departments estimate that there are 2,134,934 ERISA-covered group health plans with less than 50 participants based on data from the 2021 MEPS-IC and the 2019 County Business Patterns from the Census Bureau. The Departments also estimate that 83 percent of group health plans with less than 50 participants are fully insured based on data from the 2021 MEPS-IC. The 2020 Kaiser Employer Health Benefits Survey reported that in 2020, 16 percent of firms offering health benefits offered at least one grandfathered health plan, therefore, the Departments assume the percent of firms offering at least one non-grandfathered health plan is 84% (100% minus 16%). (Source: KFF. 2020 Kaiser Employer Health Benefits Survey.) https://files.kff.org/attachment/Report-Employer-Health-Benefits-2020-Annual-Survey.pdf). Thus, the Departments have calculated the number of fully insured, non-grandfathered plans with less than 50 participants in the following manner: 2,134,934 small ERISA-covered group health plans × 83% × 84% = 1,488,475.

³¹⁶ MHPAEA only applies to ERISA plans in the group market with 50 or more participants that offer mental health or substance use disorder benefits. The Departments have not identified what share of plans with 50 or more participants offer mental health or substance use disorder benefits and so have assumed that all of these plans offer them. The Departments seeks comments on this assumption. Based on the 2021 MEPS-IC, 25 percent of ERISA-covered group health plans with 50 to 100 participants are self-insured. Thus, the Departments calculate the number of self-insured group health plans with 50 to 100 participants based on the following manner: 152,254 ERISA-covered group health plans with less than 100 participants × 25% of ERISA-covered group health plans with 50 to 100 participants are self-insured = 38,064.

³¹⁷ Based on the 2020 Form 5500, 89 percent of self-insured plans filed a Schedule C and indicated using either a Claims Processor, Contract Administrator, or both.

³¹⁸ Based on the 2017 Census of Government, there are 90,126 State and local entities. The Departments assume that there is one plan per entity, on average. Therefore, the Departments estimate that there are 90,126 non-Federal governmental health plans. MHPAEA applies to non-Federal governmental employers with 50 or more employees that offer mental health or substance use disorder benefits. The Departments have not identified what share of plans with 50 or more participants offer mental health or substance use disorder benefits and so has have assumed that all of these plans offer them. The Departments seek comments on this assumption. Based on the 2021 Medical Expenditure Survey Insurance Component (MEPS-IC) and the 2019 County Business Patterns from the Census Bureau, 16 percent of ERISA-covered group health plans have 50 or more participants. The Departments use the percent of ERISA-covered group plans with more than 50 participants as a proxy for the percent of non-Federal governmental plans with more than 50 participants. Therefore, the Departments estimate there are 14,420 public, non-Federal employer group health plans with 50 or more participants that offer mental health or substance use disorder benefits (90,126 non-Federal governmental health plans × 16 percent of plans with 50 or more employees).

³¹⁹ The Departments’ estimate of the number of health insurance insurers and the number of issuer/State combinations is based on medical loss ratio reports submitted by issuers for the 2021 reporting year. (Source: Centers for Medicare & Medicaid Services. “Medical Loss Ratio Data and System Resources” (2021). https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.)

³²⁰ Available at: https://www.sba.gov/document/support--table-size-standards, as of March 2023.

³²¹ Available at: https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.

³²² Based on data from the NAICS Association for NAICS code 524114, the Departments estimate the percent of businesses within the industry of Direct Health and Medical Insurer Carriers with less than $47 million in annual sales. (See NAICS Association. “Market Analysis Profile: NAICS Code Annual Sales.” https://www.naics.com/business-lists/counts-by-naics-code/.)

³²³ 1,500 issuers/State combination × 8.6 percent = 129 small issuers.

³²⁴ 2 U.S.C. 1501 et seq. (1995).

³²⁵ Enhancing the Intergovernmental Partnership, 58 FR 58093 (Oct. 28, 1993).

³²⁶ Federalism, 64 FR 153 (Aug. 4, 1999).