# These synopses are intended only as aids to the reader in

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/agency%3Airs%3A683d4a7b1a692c40

## Record

- **Collection:** Agency decision
- **Document type:** Agency decision

## Text

HIGHLIGHTS
OF THIS ISSUE
These synopses are intended only as aids to the reader in
identifying the subject matter covered. They may not be
relied upon as authoritative interpretations.

EXCISE TAX
REG-120727-21, page 671.

This document proposes amendments to regulations implementing the Paul Wellstone and Pete Domenici Mental
Health Parity and Addiction Equity Act of 2008 (MHPAEA)
and proposes new regulations for the nonquantitative treatment limitation (NQTL) comparative analyses required under
MHPAEA, as amended by the Consolidated Appropriations
Act, 2021 (CAA, 2021). The regulations are issued jointly
with the Department of Health and Human Services, and the
Department of Labor.

Finding Lists begin on page ii.




Bulletin No. 2023–36
September 5, 2023

The IRS Mission
Provide America’s taxpayers top-quality service by helping
them understand and meet their tax responsibilities and
enforce the law with integrity and fairness to all.

Introduction
The Internal Revenue Bulletin is the authoritative instrument
of the Commissioner of Internal Revenue for announcing official rulings and procedures of the Internal Revenue Service
and for publishing Treasury Decisions, Executive Orders, Tax
Conventions, legislation, court decisions, and other items of
general interest. It is published weekly.
It is the policy of the Service to publish in the Bulletin all substantive rulings necessary to promote a uniform application
of the tax laws, including all rulings that supersede, revoke,
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Bulletin. All published rulings apply retroactively unless otherwise indicated. Procedures relating solely to matters of internal management are not published; however, statements of
internal practices and procedures that affect the rights and
duties of taxpayers are published.
Revenue rulings represent the conclusions of the Service
on the application of the law to the pivotal facts stated in
the revenue ruling. In those based on positions taken in rulings to taxpayers or technical advice to Service field offices,
identifying details and information of a confidential nature are
deleted to prevent unwarranted invasions of privacy and to
comply with statutory requirements.
Rulings and procedures reported in the Bulletin do not have the
force and effect of Treasury Department Regulations, but they
may be used as precedents. Unpublished rulings will not be
relied on, used, or cited as precedents by Service personnel in
the disposition of other cases. In applying published rulings and
procedures, the effect of subsequent legislation, regulations,
court decisions, rulings, and procedures must be considered,
and Service personnel and others concerned are cautioned

against reaching the same conclusions in other cases unless
the facts and circumstances are substantially the same.
The Bulletin is divided into four parts as follows:
Part I.—1986 Code.
This part includes rulings and decisions based on provisions
of the Internal Revenue Code of 1986.
Part II.—Treaties and Tax Legislation.
This part is divided into two subparts as follows: Subpart A,
Tax Conventions and Other Related Items, and Subpart B,
Legislation and Related Committee Reports.
Part III.—Administrative, Procedural, and Miscellaneous.
To the extent practicable, pertinent cross references to these
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included in this part are Bank Secrecy Act Administrative
Rulings. Bank Secrecy Act Administrative Rulings are issued
by the Department of the Treasury’s Office of the Assistant
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Part IV.—Items of General Interest.
This part includes notices of proposed rulemakings, disbarment and suspension lists, and announcements.
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The contents of this publication are not copyrighted and may be reprinted freely. A citation of the Internal Revenue Bulletin as the source would be appropriate.

September 5, 2023 

Bulletin No. 2023–36

Part IV
Notice of Proposed
Rulemaking

Requirements Related to
the Mental Health Parity
and Addiction Equity Act
REG-120727-21
AGENCY: Internal Revenue Service,
Department of the Treasury; Employee
Benefits
Security
Administration,
Department of Labor; Centers for Medicare
& Medicaid Services, Department of
Health and Human Services.
ACTION: Proposed rules.
SUMMARY: This document proposes
amendments to regulations implementing the Paul Wellstone and Pete Domenici
Mental Health Parity and Addiction
Equity Act of 2008 (MHPAEA) and
proposes new regulations implementing
the nonquantitative treatment limitation
(NQTL) comparative analyses requirements under MHPAEA, as amended by
the Consolidated Appropriations Act,
2021 (CAA, 2021). Specifically, these
proposed rules would amend the existing NQTL standard to prevent plans
and issuers from using NQTLs to place
greater limits on access to mental health
and substance use disorder benefits as
compared to medical/surgical benefits.
As part of these changes, these proposed
rules would require plans and issuers
to collect and evaluate relevant data in
a manner reasonably designed to assess
the impact of NQTLs on access to mental health and substance use disorder
benefits and medical/surgical benefits,
and would set forth a special rule with
regard to network composition. These
proposed rules would also amend existing examples and add new examples on
the application of the rules for NQTLs
to clarify and illustrate the protections
of MHPAEA. Additionally, these proposed rules would set forth the content
requirements for NQTL comparative
analyses and specify how plans and

Bulletin No. 2023–36

issuers must make these comparative
analyses available to the Department of
the Treasury (Treasury), the Department
of Labor (DOL), and the Department
of Health and Human Services (HHS)
(collectively, the Departments), as well
as to an applicable State authority, and
participants, beneficiaries, and enrollees.
The Departments also solicit comments
on whether there are ways to improve
the coverage of mental health and substance use disorder benefits through
other provisions of Federal law. Finally,
HHS proposes regulatory amendments
to implement the sunset provision for
self-funded, non-Federal governmental plan elections to opt out of compliance with MHPAEA, as adopted in the
Consolidated Appropriations Act, 2023
(CAA, 2023).
DATES: To be assured consideration,
comments must be received at one of the
addresses provided below, no later than
October 2, 2023.
ADDRESSES: Written comments may be
submitted to the address specified below.
Any comment that is submitted will be
shared with Treasury, Internal Revenue
Service (IRS), and HHS. Please do not
submit duplicates.
Comments will be made available
to the public. Warning: Do not include
any personally identifiable information
(such as name, address, or other contact information) or confidential business information that you do not want
publicly disclosed. All comments are
posted on the internet exactly as received
and can be retrieved by most internet
search engines. No deletions, modifications, or redactions will be made to the
comments received, as they are public
records. Comments may be submitted
anonymously.
In commenting, please refer to file
code 1210-AC11. Because of staff and
resource limitations, the Departments cannot accept comments by facsimile (FAX)
transmission.
Comments must be submitted in one
of the following two ways (please choose
only one of the ways listed):

671

1. Electronically. You may submit
electronic comments on this regulation to
https://www.regulations.gov. Follow the
“Submit a comment” instructions.
2. By mail. You may mail written comments to the following address
ONLY: Office of Health Plan Standards
and Compliance Assistance, Employee
Benefits Security Administration, Room
N-5653, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210, Attention: 1210-AC11.
Please allow sufficient time for mailed
comments to be received before the close
of the comment period.
Inspection of Public Comments: All
comments received before the close of the
comment period are available for viewing
by the public, including any personally
identifiable or confidential business information that is included in a comment. The
comments are posted on the following
website as soon as possible after they have
been received: https://www.regulations.
gov. Follow the search instructions on that
website to view public comments.
FOR FURTHER INFORMATION
CONTACT: Shira McKinlay, Internal
Revenue Service, Department of the
Treasury, at 202-317-5500; Beth Baum or
David Sydlik, Employee Benefits Security
Administration, Department of Labor, at
202-693-8335; David Mlawsky, Centers
for Medicare & Medicaid Services,
Department of Health and Human
Services, at 410-786-6851.
Customer Service Information:
Individuals interested in obtaining
information from DOL concerning private
employment-based health coverage laws
may call the Employee Benefits Security
Administration (EBSA) Toll-Free Hotline
at 1-866-444-EBSA (3272) or visit the
DOL’s website (www.dol.gov/agencies/
ebsa).
In addition, information from HHS on
private health insurance coverage and coverage provided by self-funded, non-Federal governmental group health plans can
be found on the Centers for Medicare
& Medicaid Services (CMS) website
(www.cms.gov/cciio), and information on
health care reform can be found at www.
Healthcare.gov or https://www.hhs.gov/

September 5, 2023

healthcare/index.html. In addition, information about mental and behavioral health
and addiction is available at https://www.
samhsa.gov/mental-health and https://
www.samhsa.gov/find-support.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
Mental health is essential to personal
and societal wellbeing. America is experiencing a mental health and substance
use disorder crisis1 that worsened during
the COVID-19 pandemic.2 This crisis
impacts both children and adults across
various demographics nationwide and disproportionately affects marginalized and
underserved communities. Recent data
from the Centers for Disease Control and
Prevention (CDC) indicate that, between
August 2020 and February 2021, the
percentage of adults exhibiting symptoms of an anxiety or depressive disorder
increased significantly, from 36.4 percent
to 41.5 percent.3
Similarly, the overdose and substance
use disorder epidemic has worsened

in recent years. Overdose death numbers have risen substantially since 2015,
reaching a then-historic high of 70,630
deaths nationally in 2019 and growing
to a reported value of 107,421 overdose
deaths in the 12-month period ending
in July 2022.4 Additionally, from 1999
through 2019, the rate of drug overdose
deaths increased from 4.0 per 100,000 to
19.6 in rural counties,5 and in 2020, the
age-adjusted rate of drug overdose deaths
increased to 26.2 per 100,000 in rural
counties.6 The number of people who died
from drug overdoses in 2021 increased
by approximately 36,000 over the prior
2 years.7 During the first year of the
COVID-19 pandemic, the overdose death
rates were highest for American Indians
and Alaska Natives and Black or African
Americans, exceeding the overdose death
rate for White people by about 30 and 16
percent, respectively.8 While Hispanic and
Latino people saw the lowest overdose
death rates, those rates still increased in
2020.9
As noted above, both children and
adolescents are also impacted by this
mental health and substance use disorder crisis. Prior to the COVID-19 public health emergency (PHE), millions of

children ages 12 to 17 reported experiencing at least one major depressive episode
or severe major depression.10 Suicidal
behavior among children has increased
sharply; known suicide attempts by
ingestion alone in children ages 10 to 12
increased by about 450 percent from 2010
to 2020.11 Suicide rates among Black or
African American children below age 13
increased rapidly from 2001 to 2015, and
those children are nearly twice as likely to
die by suicide than White children of the
same age.12 Additionally, one survey, conducted from September 20 to December
31, 2021, notes that 45 percent of Lesbian,
Gay, Bisexual, Transgender, and Queer
(LGBTQ) youth respondents ages 13 to 24
seriously considered attempting suicide in
the past year,13 including nearly half of
multiracial LGBTQ youth respondents.14
A sharp rise in eating disorders throughout the COVID-19 PHE also demonstrates
the extent of this crisis for young people.15
Emergency department visits for adolescent girls ages 12-17 with eating disorders
doubled in January 2022 as compared
to 2019,16 and children are beginning to
experience eating disorders at younger
ages.17 In addition, in 2021, nearly 3 in 5
teen girls felt persistently sad or hopeless,

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 COVID19 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.
1

September 5, 2023

672

Bulletin No. 2023–36

the highest level reported over the past
decade.18
Americans are too frequently discouraged from and forgo seeking mental
health and substance use disorders care
because of barriers, both inside and outside of the health care system, such as
discrimination, stigmatization,19 inability
to find an in-network provider accepting new patients,20 cost, and geography.
These barriers are particularly problematic for young adults ages 18-34, who are
less likely to believe their mental health
symptoms are well-managed than older
adults,21 and for people seeking substance use disorder treatment.22 One survey reports that less than seven percent
of people in need of substance use disorder treatment received care at a specialty
facility and less than 10 percent received
“any treatment,”23 while only about 19
percent of people with opioid use disorder in 2021 received life-saving medications.24 Sixty percent of rural Americans
live in mental health professional shortage
areas.25 Additionally, non-metropolitan
adults were more likely than metropolitan
adults (43.7% vs. 34.5%) to see a general
practitioner or family doctor, as opposed
to a mental health specialist, for depressive symptoms, and among non-metropolitan adults with depression, fewer than 20

percent received treatment from a mental
health professional.26
Moreover, against the backdrop of this
mental health and substance use disorder
crisis, when patients seek benefits under
their health plan or coverage, they often
find that coverage for treatment of mental
health conditions or substance use disorders operates in a separate—and too often
disparate—system than their health plan’s
coverage for treatment of medical/surgical
conditions.27 These disparities exacerbate
the hardships faced by people living with
mental health conditions and substance
use disorders. The disparities also can
magnify the challenges faced by the parents, children, and loved ones of people
living with mental health conditions or
substance use disorders as well as those
who care for them, who are profoundly
affected by the person’s illness and their
difficulties in getting, or inability to get,
coverage for needed care.28
Ensuring meaningful access to mental
health and substance use disorder care is
vital to addressing the Nation’s mental
health and substance use disorder crisis.
A key component of access is the availability of an adequate number of appropriate providers within a plan’s network. A
survey of adults with private health coverage found that plan participants were

more likely to perceive their mental health
provider networks as inadequate when
compared to medical provider networks.29
Furthermore, another survey noted that
most plan participants reported choosing
mental health services from out-of-network mental health providers based on
provider quality issues.30
A 2019 Milliman report found a growing disparity in the utilization of out-ofnetwork behavioral health care (which
the report uses to refer to care for mental
health conditions and substance use disorders) providers relative to out-of-network medical/surgical care providers.31
The same report found that the disparity
between how often out-of-network behavioral health inpatient facilities were used
relative to out-of-network medical/surgical inpatient facilities had increased 85
percent between 2013 and 2017 for people with commercial preferred provider
organization (PPO) health plans. Over the
same period, there were also increasing
disparities in the use of out-of-network
outpatient facilities and office visits for
mental health and substance use disorder
treatment relative to the use of out-of-network outpatient facilities and office visits for medical/surgical care.32 The report
additionally noted a growing disparity
in reimbursement rates (as a percentage

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.

Bulletin No. 2023–36

673

September 5, 2023

of Medicare-allowed amounts) between
in-network mental health and substance
use disorder providers and medical/surgical providers. Primary care reimbursements were, on average, 23.8 percent
higher than behavioral health office visit
reimbursements relative to Medicare
allowed amounts in 2017—up from a
20.8 percent difference in 2015.33 Low
reimbursement rates for behavioral health
providers and high demand for services,
among other factors, contribute to this
difficulty finding in-network providers,34
which can stifle efforts to receive necessary care for mental health conditions or
substance use disorders.
MHPAEA’s fundamental purpose is
to ensure that individuals in group health
plans or with group or individual health
insurance coverage who seek treatment
for covered mental health conditions or
substance use disorders do not face greater
barriers to accessing benefits for such
mental health conditions or substance use
disorders than they would face when seeking coverage for the treatment of a medical condition or for a surgical procedure.35
Such barriers are particularly problematic
when they effectively result in the loss of
benefits that the plan or issuer purports to
make available and that individuals reasonably expect to be covered, and they
contravene MHPAEA’s clear mandate that
the financial requirements and treatment
limitations applicable to mental health benefits or substance use disorder benefits be
“no more restrictive” than the predominant
requirements and limitations applicable to
substantially all medical/surgical benefits.36

MHPAEA was enacted as bipartisan legislation reflecting what Congress
saw as a shared public concern: that it is
wrong to place greater burdens on people
in need of mental health and substance
use disorder treatment than people in need
of medical/surgical treatment under the
same health coverage. However, almost
15 years after MHPAEA’s enactment,
disparities persist, as people face greater
barriers when accessing benefits for mental health and substance use disorders
under their plan or coverage than they do
when accessing medical/surgical benefits.
The Departments’ experience since the
MHPAEA final regulations were issued
in 2013 (2013 final regulations) (78 FR
68240 (Nov. 13, 2013)) has shown that too
often, group health plans and health insurance issuers offering group or individual
health insurance coverage are not operating in compliance with MHPAEA, which
can have devastating consequences for
individuals with mental health conditions
and substance use disorders and their families. The Departments continue to receive
and investigate complaints that plans and
issuers fail to comply with MHPAEA, by
continuing to restrict access to benefits for
mental health conditions and substance
use disorders in ways that are more onerous and limiting than for medical or surgical care. As reflected in recent reports
to Congress on MHPAEA compliance,
the Departments found nearly all plans
or issuers audited for MHPAEA compliance could not demonstrate compliance
with the law’s obligations in response to
an initial request for NQTL comparative

analyses.37 As a result of these failures,
participants and beneficiaries routinely
encounter additional barriers to access
and are denied needed and potentially
lifesaving care for opioid use disorder,
eating disorders, autism spectrum disorder (ASD), anxiety, depression, and other
mental health conditions and substance
use disorders. The harm to these participants and beneficiaries, and to their families, friends, co-workers, and others, is
incalculable.
In the last 2 years, the Departments
have made an unprecedented commitment
to advance parity for mental health and
substance use disorder care by making it
a top enforcement priority, especially with
respect to NQTLs.38 Specifically, EBSA,
which has primary enforcement jurisdiction over MHPAEA for approximately 2.5
million private, employment-based group
health plans covering approximately 133
million individuals, is taking extraordinary steps to enforce mental health and
substance use disorder parity requirements
and ensure that it is using its full authority to help participants and beneficiaries
receive equitable coverage for mental
health and substance use disorder treatment. Similarly, CMS continues to prioritize its MHPAEA enforcement activities
with respect to non-Federal governmental
plans nationwide39 and health insurance
issuers offering group and individual
health insurance coverage in States where
CMS is the direct enforcer of MHPAEA
with respect to issuers.40, 41
In addition to using their enforcement
authority, the Departments continue

Id. at pp. 6-7.
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.
33
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to work to reduce the stigma and discrimination that individuals with mental health conditions and substance use
disorders face, raise awareness so these
individuals can receive the treatment
they need and the benefits to which
they are entitled, and engage consumer advocates, members of the regulated community, State regulators, and
other interested parties to inform the
Departments’ efforts in addressing the
nation’s mental illness and substance
use disorder epidemic. These efforts
have helped to deepen the Departments’

understanding of the barriers to mental
health and substance use disorder treatment Americans face, inform DOL’s and
HHS’s MHPAEA enforcement approach,
and connect advocacy groups to government resources.
The Departments have also continued
to help plans, issuers, consumers, providers, States, and other interested parties
understand and comply with MHPAEA’s
requirements, including the NQTL
comparative
analysis
requirements.
Additionally, the Departments have
worked to help families, caregivers, and

individuals understand the law and benefit
from it, as Congress intended.
Since the promulgation of the 2013
final regulations on November 13, 2013,42
the Departments have provided extensive guidance and compliance assistance
materials to the regulated community,
State regulators, and other interested
parties to facilitate the implementation
and enforcement of MHPAEA, as discussed later in this preamble, including numerous sets of Frequently Asked
Questions (FAQs),43 fact sheets,44 compliance assistance tools,45 templates,46

78 FR 68240 (Nov. 13, 2013).
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/acapart-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.
42

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reports,47 and publications.48 Despite this
unprecedented outreach, plans and issuers
continue to fall short of MHPAEA’s central
mandate to ensure that participants, beneficiaries, and enrollees do not face greater
barriers and restrictions to accessing benefits for mental health conditions or substance use disorders than they face when
accessing benefits for a medical condition
or surgical procedure. This noncompliance is especially evident with respect to
the design and application of NQTLs that
apply to mental health and substance use
disorder benefits. Accordingly, Congress
amended MHPAEA in the CAA, 2021, as
described later in this preamble.
The Departments are proposing these
revised rules to reinforce MHPAEA’s fundamental objective, to ensure that limitations on mental health and substance use
disorder benefits are no more restrictive
than the limitations applicable to medical/
surgical benefits. These proposed rules
also would implement important requirements that Congress enacted in the CAA,
2021 to ensure that plans and issuers perform and document their NQTL comparative analyses and provide them to the
Departments or an applicable State authority upon request for evaluation of compliance with MHPAEA. The aim of these
proposed rules is to ensure that individuals

benefit from the full protections afforded
to them under MHPAEA, while providing
clear standards for plans and issuers on
how to comply with MHPAEA.
Specifically, the proposed regulations
would:
• Make clear that MHPAEA requires
that individuals can access their mental health and substance use disorder
benefits in parity with medical/surgical benefits.
• Provide specific examples that make
clear that plans and issuers cannot
use more restrictive prior authorization and other medical management
techniques for mental health and
substance use disorder benefits; standards related to network composition
for mental health and substance use
disorder benefits; and factors to determine out-of-network reimbursement
rates for mental health and substance
use disorder providers.
• Require plans and issuers to collect
and evaluate outcomes data and take
action to address material differences
in access to mental health and substance use disorder benefits as compared to medical/surgical benefits,
with a specific focus on ensuring
that there are not any material differences in access as a result of the

application of their network composition standards.
• Codify the requirement that plans and
issuers conduct meaningful comparative analyses to measure the impact
of NQTLs. This includes evaluating
standards related to network composition, out-of-network reimbursement
rates, and prior authorization NQTLs.
• Implement the sunset provision for
self-funded, non-Federal governmental plan elections to opt out of compliance with MHPAEA, adopted in the
CAA, 2023.
As a result of these proposals, the
Departments anticipate changes in network composition and medical management techniques that would result in more
robust mental health and substance use
disorder provider networks and fewer
and less restrictive prior authorization
requirements for individuals seeking
mental health and substance use disorder
treatment.
Under a regulatory regime in which
MHPAEA’s promise of parity is realized,
participants, beneficiaries, and enrollees
would experience financial requirements
and treatment limitations for mental health
and substance use disorder benefits that
are in parity with those applied to their
medical/surgical benefits. These proposed

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-withother-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.
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rules are designed to achieve MHPAEA’s
purpose to ensure that participants, beneficiaries, and enrollees will not face greater
restrictions on access to obtaining mental
health and substance use disorder benefits
than those for medical/surgical benefits.
At the same time, the proposed rules also
aim to ensure that benefit structures that
apply limitations that reflect independent
professional medical or clinical standards or guard against indicators of fraud,
waste, and abuse (while minimizing the
negative impact on access to appropriate
benefits) would continue to be permitted,
as the Departments are of the view that
such limitations are premised on standards
that generally provide an independent and
less suspect basis for determining access
to mental health and substance use disorder treatment. These proposed rules also
aim to ensure that plans and issuers that
offer mental health and substance use disorder benefits strive to attain and maintain
mental health and substance use disorder
treatment provider networks that are as
robust as their medical/surgical provider
networks in terms of available in-network
providers and facilities–not just as shown
by a list of names in a provider directory,
but as measured by actual provider participation and as evidenced by participant
usage.
In evaluating their compliance with
these proposed rules, plans and issuers
would be required to consider whether an
NQTL is inhibiting access to treatment for
mental health conditions and substance
use disorders by examining whether the
NQTL that applies to mental health or
substance use disorder benefits is more
restrictive than the predominant NQTL
that applies to substantially all medical/
surgical benefits within a classification of
benefits set forth under the regulations.49
A plan or issuer would also be required to
consider whether the processes, strategies,

evidentiary standards, or other factors
that it uses to design or apply an NQTL
to mental health or substance use disorder
benefits in a classification are comparable
to, and applied no more stringently than,
those used in designing and applying the
NQTL to medical/surgical benefits in
the same classification. Under these proposed rules, plans and issuers would be
required to consider data relevant to an
NQTL’s impact on participants’ or beneficiaries’50 abilities to obtain mental health
and substance use disorder benefits under
the plan or coverage relative to its impact
on access to medical/surgical benefits,
and to take action to address the potential
causes of material differences in access
identified through the data as necessary
to ensure compliance. As the proposal
makes clear, ensuring that people seeking
mental health and substance use disorder treatment do not face greater barriers
to access to benefits for such treatment
is central to the fundamental purpose of
MHPAEA. These proposed rules would
ensure that NQTLs that apply to mental
health and substance use disorder benefits
are “no more restrictive,” and that processes, strategies, evidentiary standards,
and other factors are “comparable to, and
applied no more stringently,” than those
applicable to medical/surgical benefits.
These proposed rules’ focus on access to
mental health and substance use disorder
benefits and constraints on obtaining such
benefits would add needed clarity to the
statutory requirements for the regulated
community and other interested parties.
Under the current rules, plans and
issuers are generally permitted to prepare NQTL comparative analyses without
regard to the overall impact of NQTLs on
participants and beneficiaries. This has
contributed to plans and issuers looking
for ways to characterize the processes,
strategies, evidentiary standards, and

other factors associated with an NQTL as
being “comparable” and “applied no more
stringently” through careful word choice,
without regard to how, in operation, the
limitation burdens participants and beneficiaries by limiting access to, or by limiting the scope and duration of, the plan’s or
issuer’s mental health and substance use
disorder benefits relative to medical/surgical benefits. Such limitations on mental
health and substance use disorder benefits
under the plan or coverage must be analyzed in terms of the comparative burden
on access they place (that is, whether they
are more restrictive) on individuals.
These proposed rules set forth a number
of standards that are intended to reinforce
the proper application of the statutory
and regulatory requirements; promote
compliance with the NQTL comparative analysis requirements; explain how
the various components of the regulation
work together; and ensure that the purpose
of MHPAEA, to remove greater barriers
to access to mental health and substance
use disorder benefits, is fulfilled. The
Departments recognize the value of input
from interested parties and welcome feedback on all aspects of the approach set
forth in these proposed rules, as well as
alternative approaches that would enable
the Departments to more effectively
implement MHPAEA.
B. The Mental Health Parity Act, The
Mental Health Parity and Addiction
Equity Act, and the Affordable Care Act
In 1996, Congress enacted the Mental
Health Parity Act of 1996 (MHPA 1996),
which required parity in aggregate lifetime and annual dollar limits for mental
health benefits and medical/surgical benefits. These mental health parity provisions
were codified in Employee Retirement
Income Security Act of 1974 (ERISA)

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.
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section 712, PHS Act section 2705, and
Internal Revenue Code (Code) section
9812, and applied to group health plans
and health insurance coverage offered in
connection with a group health plan.51
MHPAEA was enacted on October 3,
2008, as sections 511 and 512 of the Tax
Extenders and Alternative Minimum Tax
Relief Act of 2008 (Division C of Pub. L.
110-343, 122 Stat. 3765), to amend ERISA
section 712, PHS Act section 2705, and
Code section 9812 to add new requirements, including provisions to apply the
mental health parity requirements to substance use disorder benefits, and make
further amendments to the existing mental
health parity provisions.
MHPAEA, as enacted, generally
requires that group health plans and
health insurance issuers offering group
health insurance coverage ensure that
the financial requirements and treatment
limitations applicable to mental health
or substance use disorder benefits be no
more restrictive than those applicable to
medical/surgical benefits and that there
be no separate financial requirements and
treatment limitations applicable only with
respect to mental health or substance use
disorder benefits. Together with the existing requirements for parity in aggregate
lifetime and annual dollar limits, this is
referred to as providing mental health and
substance use disorder benefits “in parity”
with medical/surgical benefits.
The Patient Protection and Affordable
Care Act (Pub. L. 111-148, 123 Stat.
3028) was enacted on March 23, 2010,
and the Health Care and Education
Reconciliation Act of 2010 (Pub. L.

111-152, 124 Stat. 1029) was enacted
on March 30, 2010 (collectively, the
Affordable Care Act). The Affordable
Care Act reorganized, amended, and
added to the provisions of part A of title
XXVII of the PHS Act relating to group
health plans and health insurance issuers
in the group and individual markets. The
Affordable Care Act added section 715(a)
(1) to ERISA and section 9815(a)(1) to
the Code to incorporate the provisions of
part A of title XXVII of the PHS Act into
ERISA and the Code, and to make them
applicable to group health plans and
health insurance issuers providing health
insurance coverage in connection with
group health plans. The PHS Act sections
incorporated by these references are sections 2701 through 2728.
The Affordable Care Act extended
MHPAEA to apply to individual health
insurance coverage and redesignated
MHPAEA in the PHS Act as section
2726.52 Additionally, section 1311(j) of
the Affordable Care Act applies PHS Act
section 2726 to qualified health plans
(QHPs)53 in the same manner and to the
same extent as to health insurance issuers and group health plans. Furthermore,
HHS’ regulations regarding essential
health benefits (EHBs)54 require health
insurance issuers offering non-grandfathered health insurance coverage in the
individual and small group markets to
comply with MHPAEA and its implementing regulations in order to satisfy the
requirement to cover “mental health and
substance use disorder services, including
behavioral health treatment,” as part of
EHBs.55

On April 28, 2009, the Departments
published a request for information soliciting comments on issues under MHPAEA
(2009 RFI).56 Over the next few years,
the Departments considered comments
regarding MHPAEA and issued further
clarifications and guidance. On February
2, 2010, the Departments published
interim final regulations implementing
MHPAEA (interim final regulations).57
After considering the comments and other
feedback received from interested parties,
the Departments published the 2013 final
regulations.58
The 2013 final regulations established
an exhaustive list of six classifications of
benefits (not counting the exhaustive list
of permissible sub-classifications also
articulated in the 2013 final regulations):
inpatient, in-network; inpatient, out-ofnetwork; outpatient, in-network; outpatient, out-of-network; emergency care;
and prescription drugs. If a plan or health
insurance coverage provides benefits for a
mental health condition or substance use
disorder in any of these classifications of
benefits, benefits for that condition or disorder must be provided in every classification in which medical/surgical benefits
are provided. The 2013 final regulations
specify that the parity requirements apply
to financial requirements, such as deductibles, copayments, and coinsurance;
quantitative treatment limitations that are
expressed numerically, such as day or visit
limits; and NQTLs, which are generally
non-numerical requirements that limit the
scope or duration of benefits, such as prior
authorization requirements, step therapy
requirements, and standards for provider

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).
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).
51
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admission to participate in a network,
including methodologies for determining
reimbursement rates.
Under MHPAEA, financial requirements and treatment limitations imposed
on mental health or substance use disorder
benefits cannot be more restrictive than
the predominant financial requirements
and treatment limitations that apply to
substantially all medical/surgical benefits
in a classification.59 The 2013 final regulations defined the “substantially all”
numerical standard for a financial requirement or quantitative treatment limitation
as two-thirds, using the same approach as
the regulations implementing MHPA 1996
with respect to aggregate annual and lifetime limits.60 The 2013 final regulations
also quantified “predominant” to mean the
level of the financial requirement or quantitative treatment limitation that applies
to more than one-half of medical/surgical
benefits in the relevant classification subject to the financial requirement or quantitative treatment limitation. Using these
numerical standards, the Departments
established a mathematical test by which
plans and issuers could determine if a
financial requirement or quantitative treatment limitation that applies to medical/
surgical benefits in a classification may be
applied to mental health and substance use
disorder benefits in that classification, and
if so, what level of the financial requirement or quantitative treatment limitation
is the most restrictive level that could be
imposed on mental health or substance use
disorder benefits within the classification.
MHPAEA generally prohibits separate
financial requirements and treatment limitations that apply only to mental health
and substance use disorder benefits.61 The
2013 final regulations also prohibit plans
and issuers from applying separate cumulative financial requirements, such as

deductibles or out-of-pocket maximums,
or separate cumulative quantitative treatment limitations, such as annual or lifetime day or visit limits, to mental health
or substance use disorder benefits in a
classification.62
In addition, the 2013 final regulations require that a group health plan or
health insurance issuer may not impose
an NQTL with respect to mental health
and 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 applying the NQTL to
mental health and 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 to medical/surgical benefits in the same classification.63 The 2013
final regulations also implemented the
statutory disclosure requirements imposed
on group health plans and health insurance issuers that are subject to MHPAEA’s
requirements.64
C. Guidance
As described earlier in this preamble,
since the promulgation of the 2013 final
regulations, the Departments have provided extensive guidance and compliance assistance materials to the regulated
community, State regulators, and other
interested parties to facilitate the implementation and enforcement of MHPAEA.
Specifically, the Departments have jointly
issued 15 sets of FAQs with 96 questions,
eight enforcement fact sheets, six compliance assistance tools and templates, seven
reports to Congress, six press releases, and
seven consumer publications. In general,

the Departments’ FAQs are designed to
provide additional guidance and clarification on how MHPAEA applies in
specific contexts and are informed by
questions raised by interested parties and
scenarios encountered in the context of
the Departments’ enforcement efforts.
For example, FAQs Part 34 addresses
how MHPAEA applies to treatment of
substance use disorders (such as treating opioid use disorder with medication)
and provides examples of impermissible
NQTLs (such as more stringent fail-first
or step-therapy requirements, including
where an individual cannot reasonably
satisfy if there are no available providers that can provide services related to
the requirement in the participant’s geographic area).65
Guidance issued by the Departments
also reflects stakeholder feedback and,
in several instances, guidance documents
were proposed before they were issued in
final form. For example, the Departments
proposed FAQs Part 39 on April 23, 2018.
The finalized FAQs Part 39 was issued
on September 5, 2019, and incorporate
insights from the regulated community
regarding compliance issues faced by
plans and issuers, as well as issues faced
by plan participants and their authorized
representatives when seeking information
about mental health and substance use disorder benefits. FAQs Part 39 also provides
guidance on how the law and regulations
apply to treatments for eating disorders,
opioid use disorder, and ASD, as well as
exclusions for experimental or investigative treatments, and standards for provider
admission to a plan’s or issuer’s network,
including the methodology for determining reimbursement rates for mental health
and substance use disorder providers.66
In addition to FAQs issued after the
promulgation of the 2013 final regulations,

Code section 9812(a)(3)(A), ERISA section 712(a)(3)(A), and PHS Act section 2726(a)(3)(A).
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.
59
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the Departments have issued, generally
every 2 years, an updated compliance program guidance document (the MHPAEA
Self-Compliance Tool), which is intended
to help plans and issuers, State regulators, and other interested parties comply
with and understand MHPAEA and the
additional related requirements under
ERISA that apply to group health plans.
The Departments most recently issued the
MHPAEA Self-Compliance Tool in 2020
(2020 MHPAEA Self-Compliance Tool).67
The 2020 MHPAEA Self-Compliance
Tool includes an illustrative, non-exhaustive list of NQTLs, a process for conducting NQTL comparative analyses, a list of
the types of documents and information
that a plan or issuer should have available to support its analyses, and illustrations of specific fact patterns to aid in
compliance.68
The 2020 MHPAEA Self-Compliance
Tool includes a stepwise process a plan
or issuer can follow to perform an analysis assessing whether its NQTLs satisfy
MHPAEA’s parity requirements.69 Under
this stepwise process, the plan or issuer
should identify all NQTLs that apply to
benefits under the plan or coverage. The
plan or issuer should also identify all
the medical/surgical benefits and mental
health and substance use disorder benefits
to which each NQTL applies. After identifying all NQTLs and the benefits to which
each NQTL applies, the 2020 MHPAEA
Self-Compliance Tool suggests the plan
or issuer identify the factors considered
in the design of each NQTL. The plan
or issuer should also identify the sources
used to define those factors. Plans and
issuers have flexibility in determining the
factors and sources of factors to apply to
NQTLs, so long as they are comparable
and applied no more stringently to mental
health and substance use disorder benefits
than to medical/surgical benefits in the
respective benefits classification. When
identifying the sources of the factors

considered in designing an NQTL, the
plan or issuer should also identify any
threshold of a factor that will implicate
the NQTL.
After identifying the plan’s NQTLs,
their application to mental health and substance use disorder benefits and to medical/surgical benefits, the factors used in
designing each NQTL, and the sources
of those factors, the plan or issuer should
determine whether the processes, strategies, and evidentiary standards used in
applying the NQTL are comparable and
no more stringently applied to mental
health and substance use disorder benefits
than to medical/surgical benefits, both as
written and in operation, in the relevant
benefit classification. For instance, if a
plan’s or issuer’s utilization review is conducted by different entities or individuals
for mental health and substance use disorder benefits and medical/surgical benefits,
the plan or issuer should have measures in
place to ensure comparable application of
utilization review policies.
The 2020 MHPAEA Self-Compliance
Tool stresses that measuring and evaluating results and quantitative outcomes can
be helpful to identify potential areas of
noncompliance. For example, comparing
a plan’s or issuer’s average reimbursement rates for both mental health and
substance use disorder providers and medical/surgical providers against an external
benchmark of reimbursement rates, such
as Medicare, may help identify whether
the underlying methodology used to determine the plan’s or issuer’s reimbursement
rates warrants additional review. The
2020 MHPAEA Self-Compliance Tool
notes that substantially disparate results
are a red flag that a plan or issuer may be
imposing an NQTL on mental health and
substance use disorder benefits in a way
that fails to satisfy the parity requirements.
Other warning signs of potential noncompliance identified in the 2020 MHPAEA
Self-Compliance Tool include generally

paying at or near Medicare reimbursement rates for mental health or substance
use disorder benefits, while paying much
more than Medicare reimbursement rates
for medical/surgical benefits, and reimbursing psychiatrists, on average, less
than medical/surgical physicians for the
same evaluation and management codes.70
The 2020 MHPAEA Self-Compliance
Tool also provides many compliance tips
on how an NQTL should be analyzed.
For example, a plan or issuer should have
information available to substantiate how
factors are used to design or apply any
specific NQTL to both medical/surgical
benefits and mental health or substance
use disorder benefits. The plan or issuer
should be clear as to whether and why
any factors were given more weight than
others and should be able to explain any
variation in the application of a guideline or evidentiary standard, including
the process and factors relied upon for
establishing the variation. To comply
with MHPAEA’s parity requirements,
plans and issuers must adopt measures
for mental health and substance use disorder providers that are at least comparable to and no more stringently applied
(with regard to limiting the scope and
duration of a participant’s, beneficiary’s,
or enrollee’s benefits under the plan or
coverage) than those applied to medical/
surgical providers. This includes taking
steps to help address provider shortages,
ensure an adequate network of mental
health and substance use disorder providers, and ensure reasonable patient
wait times to avoid noncompliance with
MHPAEA’s parity requirements. By providing a basic framework for plans and
issuers to do a stepwise analysis and providing additional warning signs and tips,
the 2020 MHPAEA Self-Compliance
Tool has provided additional guidance
for plans and issuers to comply with the
requirements of MHPAEA with respect
to NQTLs.

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.

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D. The Consolidated Appropriations Act,
2021 and Related Guidance
The CAA, 2021 was enacted on
December 27, 2020.71 Section 203 of
Title II of Division BB of the CAA, 2021
amended MHPAEA, in part, by adding
Code section 9812(a)(8), ERISA section
712(a)(8), and PHS Act section 2726(a)
(8) to expressly require group health
plans and health insurance issuers offering group or individual health insurance
coverage that include both medical/surgical benefits and mental health or substance use disorder benefits and impose
NQTLs on mental health or substance
use disorder benefits to perform and
document their comparative analyses of
the design and application of NQTLs.72
Further, plans and issuers are required
to make their comparative analyses and
other applicable information available
to the Departments or applicable State
authorities, upon request.73 The comparative analysis requirement took effect on
February 10, 2021, 45 days after the date
of enactment of the CAA, 2021.
In order to advance compliance with
MHPAEA, the CAA, 2021 states that the
Departments shall request that a group
health plan or health insurance issuer
offering group or individual health insurance coverage submit comparative analyses, with respect to a plan or coverage,
that involve potential MHPAEA violations, in response to complaints against
a plan or coverage regarding potentially
noncompliant NQTLs, and in any other
instances that the Departments determine
appropriate.74 These comparative analyses
must include:
(1) the specific plan or coverage terms
or other relevant terms regarding the
NQTLs and a description of all mental
health and substance use disorder benefits and medical/surgical benefits to which

each such term applies in each benefit
classification;
(2) the factors used to determine how
the NQTLs will apply to mental health or
substance use disorder benefits and medical/surgical benefits;
(3) the evidentiary standards used to
develop the identified factors, when applicable, provided that each factor shall be
defined, and any other source or evidence
relied upon to design and apply the NQTLs
to mental health or substance use disorder
benefits and medical/surgical benefits;
(4) the comparative analyses demonstrating that the processes, strategies, evidentiary standards, and other factors used
to apply the NQTLs to mental health or
substance use disorder benefits, as written
and in operation, are comparable to, and
are applied no more stringently than those
used to apply the NQTLs to medical/surgical benefits in the benefits classification;
and
(5) the specific findings and conclusions reached by the plan or issuer,
including any results of the analyses
that indicate that the plan or coverage is
or is not in compliance with MHPAEA
requirements.75
The CAA, 2021 further sets forth a
process by which the Departments must
evaluate the requested NQTL comparative analyses and enforce the comparative analyses requirements. If the relevant
Department with jurisdiction over the
group health plan (or health insurance
coverage) determines that a plan or issuer
has not provided sufficient information
for the relevant Department to review the
comparative analyses, the CAA, 2021
provides that the Departments shall specify the information the plan or issuer must
submit to be responsive to the request.76 In
instances in which the Departments have
reviewed the requested comparative analyses and determined that the plan or issuer

is not in compliance with MHPAEA, the
plan or issuer must specify the actions it
will take to come into compliance and
submit additional comparative analyses
that demonstrate compliance not later than
45 days after the initial determination of
noncompliance.77 Following the 45-day
corrective action period, if the relevant
Department makes a final determination
that the plan or issuer is still not in compliance, the plan or issuer must notify all
individuals enrolled in the plan or coverage of this determination, not later than 7
days after such final determination.78
The CAA, 2021 also requires the
Departments, after review of the comparative analyses, to share information on findings of compliance and noncompliance
with the State where the plan is located or
the State where the issuer is licensed to do
business, in accordance with any information sharing agreement entered into with
the State.79 Additionally, as explained
in more detail later in this preamble, the
CAA, 2021 requires the Departments to
submit annually to Congress and make
publicly available a report summarizing
the comparative analyses requested by
the Departments. The report must state, in
part, whether each plan or issuer submitted
sufficient information to permit review;
whether and why the plan or issuer is in
compliance with MHPAEA; the specific
information each plan or issuer needed
to submit to allow for a review of their
comparative analysis; and, for each plan
or issuer the Departments determined not
to be in compliance, specifications of the
actions that must be taken to come into
compliance.80
On April 2, 2021, the Departments
issued FAQs Part 45 to provide guidance
on the amendments to MHPAEA made
by the CAA, 2021 and to promote compliance by plans and issuers. FAQs Part
45 underscores that, for a comparative

Pub. L. 116-260, 134 Stat. 1182 (Dec. 27, 2020).
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).
71
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analysis to be treated as sufficient under
the CAA, 2021, it must contain a detailed,
written, and reasoned explanation of the
specific plan terms and practices at issue
and include the bases for the plan’s or
issuer’s conclusion that the NQTL complies with MHPAEA. As FAQs Part 45
explains, at a minimum, a sufficient
NQTL comparative analysis must include
a robust discussion of certain elements,
including a clear description of the specific NQTL; plan terms; policies at issue;
and identification of any factors, evidentiary standards, sources, strategies, and
processes considered in the design and
application of the NQTL and in determining which benefits, including both mental
health and substance use disorder benefits
and medical/surgical benefits, are subject to the NQTL. To the extent a plan or
issuer defines any of the factors, evidentiary standards, strategies, or processes in
a quantitative manner, its analysis should
include the precise definitions used and
any supporting sources. The analysis also
should explain whether the plan or issuer
imposes any variation in the application
of a guideline or standard between mental health and substance use disorder benefits and medical/surgical benefits, and
if so, should describe the processes and
factors used for establishing that variation. The plan or issuer should provide a
reasoned discussion, including citations
or any specific evidence of its findings
and conclusions, as to the comparability
of the processes, strategies, evidentiary
standards, factors, and sources identified
within each affected classification and
their relative stringency, both as written
and in operation.
FAQs Part 45 highlights that a general statement of compliance by plans
and issuers, coupled with a conclusory
reference to broadly stated processes,
strategies, evidentiary standards, or other

factors is insufficient to meet the statutory requirements for an NQTL comparative analysis. Accordingly, a comparative
analysis that consists of conclusory or
generalized statements, without specific
supporting evidence and detailed explanations, or the production of a large volume
of documents without a clear explanation
of how and why each document is relevant
to the comparative analysis, fails to satisfy
the statutory requirements.
In addition, FAQs Part 45 provides
guidance as to the types of documents that
plans and issuers should be prepared to
make available to support the analysis and
conclusions reached in their comparative
analyses. This includes records documenting NQTL processes and detailing how
the plan or issuer applies NQTLs to both
medical/surgical and mental health or substance use disorder benefits, documents
and other information relevant to the factors identified, and samples of covered
and denied mental health or substance
use disorder and medical/surgical benefits
claims. FAQs Part 45 also highlights several NQTLs that DOL anticipated focusing on in the near term.
FAQs Part 45 also notes that under the
CAA, 2021, plans and issuers must make
available their respective comparative
analyses of NQTLs and other applicable
information to the applicable State authority upon request. Additionally, plans and
issuers must make the comparative analyses and other applicable information
required by the CAA, 2021 available upon
request to participants and beneficiaries
in plans subject to ERISA and to participants, beneficiaries, and enrollees in all
non-grandfathered group health plans and
non-grandfathered group or individual
health insurance coverage upon request in
connection with an appeal of an adverse
benefit determination. If a provider or
other individual is acting as a patient’s

authorized representative, the provider
or other authorized representative may
request these documents.
E. Reports to Congress
DOL is required to send Congress a
biennial report on MHPAEA implementation,81 and the Departments are required to
send Congress an annual report on NQTL
comparative analyses reviews.82 To satisfy
these requirements, on January 25, 2022,
the Departments issued the first report
to Congress since the enactment of the
CAA, 2021 (2022 MHPAEA Report to
Congress).83 The 2022 MHPAEA Report
to Congress contains extensive descriptions of the Departments’ MHPAEA
enforcement efforts, outreach efforts, consumer and compliance assistance efforts,
and guidance to interested parties, including information related to the requirement
that plans and issuers perform and document comparative analyses with respect to
the design and application of NQTLs.
Contemporaneously with these proposed rules, the Departments are issuing the second report to Congress since
the enactment of the CAA, 2021, the
MHPAEA Comparative Analysis Report
to Congress, July 2023 (2023 MHPAEA
Report to Congress).84 The 2023 MHPAEA
Report to Congress details efforts by the
Departments to implement and enforce
the amendments to MHPAEA made by the
CAA, 2021. The 2023 MHPAEA Report
to Congress focuses on the Departments’
enforcement efforts regarding NQTLs
during the second year of CAA, 2021
implementation, looks broadly at the
18-month period since plans and issuers
were first required to make their comparative analyses and other applicable information available on request, discusses
common deficiencies in comparative
analyses submitted by plans and issuers,

ERISA section 712(f).
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.
81
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and explores examples of results that
the Departments have achieved through
enforcement.
The 2023 MHPAEA Report to Congress
notes that nearly all of the comparative
analyses reviewed by the Departments
during the relevant time period contained
insufficient information upon initial receipt
and identifies common deficiencies in the
comparative analyses prepared by plans
and issuers. Specifically, many initial
responders seemed unprepared to submit
their comparative analyses upon request
and some plans did not complete or start
a comparative analysis until after one
was requested. Some comparative analyses lacked specific supporting evidence,
detailed explanations, or sufficient detail to
draw meaningful comparisons. For example, many plans’ comparative analyses
failed to adequately explain whether or how
factors were comparably applied to mental
health and substance use disorder benefits and to medical/surgical benefits. Also,
many plans and issuers provided supporting
documents for which the relevance and probative value was not readily apparent.
Some plans also failed to identify the
specific mental health or substance use
disorder benefits and medical/surgical
benefits or MHPAEA benefit classification
to which an NQTL applied. Additionally,
some comparative analyses failed to identify or define every relevant factor. In other
instances, plans failed to demonstrate the
application of identified factors in the
design of an NQTL, and most comparative analyses failed to evaluate the relative
stringency of how the NQTL was applied
to mental health or substance use disorder
benefits versus medical/surgical benefits.
When data was included in a comparative
analysis, the data often lacked meaning
because the plan or issuer did not provide a description of its source, how the
source was selected, or information about
underlying calculations. Many comparative analyses for standards to participate

in a network did not adequately address
apparent differences in access standards
for medical/surgical providers as opposed
to mental health and substance use disorder providers, such as different time and
distance standards or provider-to-member
ratios.
F. MHPAEA Opt Out for Self-Funded
Non-Federal Governmental Plans
Prior to the enactment of the Affordable
Care Act, PHS Act section 2721(b)(2), as
added by the Health Insurance Portability
and Accountability Act of 1996 (HIPAA),
permitted sponsors of self-funded,
non-Federal governmental plans to elect
to exempt those plans from (that is, “opt
out of”) any or all of the following requirements of title XXVII of the PHS Act:
1. Limitations on preexisting condition
exclusion periods under PHS Act section
2701 (redesignated as section 2704 by the
Affordable Care Act).
2. Requirements for special enrollment periods under PHS Act section
2701 (redesignated as section 2704 by the
Affordable Care Act).
3. Prohibitions against discriminating
against individual participants and beneficiaries based on health status (but not
including provisions added by the Genetic
Information Nondiscrimination Act of
2008) under PHS Act section 2702 (redesignated as section 2705 by the Affordable
Care Act).
4. Standards relating to benefits for
newborns and mothers under PHS Act
section 2704 (redesignated as section
2725 by the Affordable Care Act).
5. Parity in the application of certain
limits to mental health and substance use
disorder benefits (including requirements
of MHPAEA) under PHS Act section
2705 (redesignated as section 2726 by the
Affordable Care Act).
6. Required coverage for reconstructive
surgery following mastectomies under

PHS Act section 2706 (redesignated as
section 2727 by the Affordable Care Act).
7. Coverage of dependent students on
a medically necessary leave of absence
under PHS Act section 2707 (redesignated
as section 2728 by the Affordable Care
Act).
The Affordable Care Act redesignated
PHS Act section 2721 as section 2722 and
amended PHS Act section 2722(a)(2) to
allow sponsors of self-funded, non-Federal governmental plans to only opt out of
requirements categories 4-7 listed above.
In response to the Affordable Care Act
amendments, HHS issued guidance on
September 21, 2010, indicating that, for
plan years beginning on or after September
23, 2010, plan sponsors of non-collectively bargained plans could elect to be
exempt only from requirements categories
4–7 listed above and that requirements
categories 1–3 were no longer available
for exemption.85 Group health plans maintained pursuant to a collective bargaining
agreement ratified before March 23, 2010,
and that had been exempted from any of
the first three requirements categories
listed above, would not have to come into
compliance with those requirements categories until the commencement of the first
plan year following the expiration of the
last plan year governed by the collective
bargaining agreement.
On March 21, 2014, HHS published
proposed regulations in the Federal
Register that proposed to revise the provisions of 45 CFR 146.180 to reflect the
amendments made by the Affordable Care
Act, consistent with the September 21,
2010, guidance.86 On May 27, 2014, HHS
finalized those proposed regulations with
modifications related to how opt out elections must be filed.87
The CAA, 2023,88 enacted on
December 29, 2022, eliminated the election for self-funded, non-Federal governmental plans to opt out of MHPAEA.89
Specifically, PHS Act section 2722(a)(2),

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).
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September 5, 2023

as amended by the CAA, 2023, provides
that no election to opt out of compliance
with the requirements of MHPAEA may
be made on or after December 29, 2022
(the date of enactment of the CAA, 2023)
and that generally no such election with
respect to MHPAEA expiring on or after
June 27, 2023 (the date that is 180 days
after the date of enactment of the CAA,
2023), may be renewed.90 In addition,
PHS Act section 2722(a)(2), as amended
by the CAA, 2023, includes an exception
for certain collectively bargained plans.
Specifically, a self-funded, non-Federal
governmental plan that is subject to multiple collective bargaining agreements of
varying lengths and that has a MHPAEA
opt-out election in effect on December
29, 2022, that expires on or after June 27,
2023, may extend such election until the
date on which the term of the last collective bargaining agreement expires.91
HHS issued a Bulletin on June 7, 2023,
that informs self-funded, non-Federal
governmental plans and other interested
parties about the CAA, 2023 amendments
to PHS Act section 2722(a)(2), outlines
when plans that currently opt out of compliance with MHPAEA are required to
come into compliance with these requirements, and specifies the form and manner
for submission of opt-out renewal election
requests92 to operationalize the special rule
for certain collectively bargained plans.93
II. Overview of the Proposed Rules –
Departments of the Treasury, Labor,
and HHS
The Departments are proposing these
rules to further MHPAEA’s fundamental goal of ensuring that limitations on
mental health and substance use disorder
benefits provided by group health plans
or health insurance issuers offering group
or individual health insurance coverage

are no more restrictive than the predominant limitations applicable to substantially
all medical/surgical benefits, and to further implement important new statutory
requirements to ensure that plans and issuers document their NQTL comparative
analyses and other applicable information
to demonstrate whether the processes,
strategies, evidentiary standards, and
other factors used to apply an NQTL to
mental health and substance use disorder
benefits are comparable to, and applied no
more stringently than, those used to apply
the limitation with respect to medical/surgical benefits in the same benefit classification. The goal of these proposed rules
is to ensure that individuals with mental
health conditions and substance use disorders can benefit from the full protections
afforded to them under MHPAEA, while
offering clear guidance to plans and issuers on how to comply with MHPAEA’s
requirements.
These proposed rules would be codified in 26 CFR part 54, 29 CFR part
2590, and 45 CFR parts 146 and 147.
Specifically, these proposed rules would
amend certain provisions of existing
MHPAEA regulations at 26 CFR 54.98121, 29 CFR 2590.712, and 45 CFR 146.136
to incorporate new and revised definitions of key terms, as well as to specify
additional steps that plans and issuers
must take to meet their obligations under
MHPAEA. These proposed rules also
would add a new regulation at 26 CFR
54.9812-2, 29 CFR 2590.712-1, and 45
CFR 146.137 establishing minimum standards for developing NQTL comparative
analyses to assess whether an NQTL, as
written and in operation, complies with
MHPAEA’s requirements. In addition,
these proposed rules would set forth the
content elements of comparative analyses
and the timeframe for plans and issuers to
respond to a request from the Departments

to submit their comparative analyses.
Additionally, HHS proposes an amendment to 45 CFR 147.160 to specify that
proposed regulations at 45 CFR 146.137
would apply to individual health insurance coverage offered by a health insurance issuer in the same manner and to the
same extent that this proposed provision
would apply to health insurance coverage
offered by a health insurance issuer in
connection with a group health plan in the
large group market.94 Consistent with the
existing text at 45 CFR 147.160(a), HHS
also proposes to extend the same requirements and framework outlined in the proposed amendments to 45 CFR 146.136 in
these proposed rules to individual health
insurance coverage in the same manner
and to the same extent as such proposed
amendments, if finalized, would apply to
group health insurance coverage. Finally,
HHS also proposes amendments to 45
CFR 146.180 to reflect the sunset of the
election option for self-funded, non-Federal governmental plans to opt out of compliance with MHPAEA, consistent with
changes made by the CAA, 2023 to PHS
Act section 2722(a)(2).95
The Departments are soliciting public
comment on all aspects of these proposed
rules.
A. Amendments to Existing Regulations
at 26 CFR 54.9812-1, 29 CFR 2590.712,
and 45 CFR 146.136
1. Purpose Section - 26 CFR 54.98121(a)(1), 29 CFR 2590.712(a)(1), and 45
CFR 146.136(a)(1)
In general, the fundamental purpose
of MHPAEA, its existing implementing
regulations, and these proposed rules is to
ensure that participants and beneficiaries
in a group health plan or in group health
insurance coverage offered by a health

PHS Act section 2722(a)(2)(F)(i).
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).
90
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insurance issuer that offers mental health
or substance use disorder benefits are not
subject to greater restrictions, such as
more restrictive lifetime or annual dollar
limits, financial requirements, or treatment limitations, when seeking those benefits than when they seek medical/surgical
benefits under the terms of the plan or
coverage. This should serve as the guiding
principle for group health plans and health
insurance issuers offering group health
insurance coverage as they work to comply with MHPAEA and its implementing
regulations. While MHPAEA generally
does not mandate coverage of mental
health or substance use disorder benefits,
these proposed rules aim to better ensure
that plans and issuers that cover such benefits implement MHPAEA in accordance
with its express terms and fundamental
purpose.
Accordingly, the Departments propose
to add a purpose section to the regulations, specifying that a fundamental purpose of MHPAEA and its implementing
regulations is to ensure that participants
and beneficiaries covered under a plan
or health insurance coverage 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 covered mental health
and substance use disorder 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.96 The purpose section would
further state that in complying with the
provisions of MHPAEA and its implementing regulations, 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 plans and issuers
impose on access to generally comparable
medical/surgical benefits. Further, these
proposed rules provide that MHPAEA and
its implementing regulations should be
interpreted in a manner that is consistent
with this purpose. The Departments seek
comment on the proposed addition of a
purpose section to the implementing regulations and the proposed language.
2. Meaning of Terms - 26 CFR 54.98121(a)(2), 29 CFR 2590.712(a)(2), and 45
CFR 146.136(a)(2)
The Departments propose to amend
the 2013 final regulations to revise several
existing definitions, add new definitions
of key terms, and add language to specify
that, except where the context clearly indicates otherwise, the definitions in 26 CFR
54.9812-1(a)(2), 29 CFR 2590.712(a)
(2), and 45 CFR 146.136(a)(2) would
also apply to the new proposed comparative analysis requirements set forth in
proposed 26 CFR 54.9812-2, 29 CFR
2590.712-1, and 45 CFR 146.137, which
are discussed in more detail later in this
preamble.97
Under MHPAEA, the term “medical
or surgical benefits” means benefits with
respect to medical or surgical services,
as defined under the terms of the plan
or coverage.98 This statutory definition
further clarifies that the term does not
include mental health or substance use
disorder benefits.99 The terms “mental
health benefits” and “substance use disorder benefits” are defined by the statute to
mean benefits with respect to services for
mental health conditions or substance use
disorders, respectively, as defined under
the terms of the plan and in accordance
with applicable Federal and State law.100
The definitions of all three of these terms

included in the 2013 final regulations further provide that any condition defined
by the plan or coverage as being or as
not being a medical/surgical condition,
mental health condition, or substance use
disorder, respectively, must be defined to
be consistent with generally recognized
independent standards of current medical
practice (for example, the most current
version of the Diagnostic and Statistical
Manual of Mental Disorders (DSM), the
most current version of the International
Classification of Diseases (ICD), or State
guidelines).
The Departments have received questions from interested parties about what it
means for a definition of a mental health
condition or substance use disorder to be
“consistent with” generally recognized
independent standards of current medical practice, and whether, for purposes of
MHPAEA, a condition is a medical condition, a mental health condition, or a substance use disorder when State insurance
law and generally recognized independent
standards of current medical practice conflict. In response to these requests for further guidance, the Departments propose to
amend the existing regulatory definitions
of the terms “medical/surgical benefits,”
“mental health benefits,” and “substance
use disorder benefits” to address these
questions and help delineate more clearly
what is a medical/surgical benefit, a mental health benefit, or a substance use disorder benefit for purposes of complying
with MHPAEA.
Specifically, the Departments propose to amend the definition of the term
“medical/surgical benefits” to mean 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

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).
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with applicable Federal and State law, but
does not include mental health benefits
or substance use disorder benefits. These
proposed rules would also amend this
regulatory definition of “medical/surgical
benefits” to provide that, notwithstanding
the first sentence, any condition or procedure defined by the plan or coverage as
being or 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 that 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 as medical/surgical benefits, as long
as such definitions are in accordance with
applicable Federal and State law.
The Departments propose to remove
the reference to State guidelines in the
definition of medical/surgical benefits.
This proposed amendment is more consistent with the statute, and importantly,
would no longer allow plans and issuers
to rely on standards that are not applicable
to the plan or coverage at issue in applying
financial requirements or treatment limitations to mental health and substance use
disorder benefits.101 Generally recognized
independent standards of current medical
practice more accurately align with how a
plan should characterize benefits for purposes of compliance with MHPAEA, and
this provision would minimize situations
where contradictions with State guidelines
create conflicts and improperly limit the
protections under MHPAEA.
The Departments propose to make similar changes to the definitions of “mental
health benefits” and “substance use disorder benefits” by amending the first sentences of these definitions, removing the
reference to State guidelines, and clarifying that, notwithstanding the terms of
a plan or coverage, any condition or disorder defined by the plan or coverage as

being or not being a mental health condition or a substance use disorder must be
defined to be consistent with generally recognized independent standards of current
medical practice. Specifically, under these
proposed rules, to be consistent with generally recognized independent standards
of current medical practice, the plan’s or
coverage’s definition of “mental health
benefits” 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. Similarly, the plan’s
or coverage’s definition of “substance
use disorders” 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.102 Similar to the proposed revisions
to the definition of “medical/surgical benefits,” the proposed amended definitions
of “mental health benefits” and “substance
use disorder benefits” also provide that, to
the extent generally recognized independent standards of current medical practice do not address whether a condition
or disorder is a mental health condition
or substance use disorder, respectively,
plans and issuers may define the condition
or disorder in accordance with applicable
Federal and State law.
The ICD would be defined as the
World Health Organization’s International
Classification of Diseases adopted by
HHS through 45 CFR 162.1002 or successor regulations, and the DSM would
be defined as the American Psychiatric

Association’s Diagnostic and Statistical
Manual of Mental Disorders. Because the
proposed amendments to the definitions
of “medical/surgical benefits,” “mental
health benefits,” and “substance use disorder benefits,” refer to the most current
version of the ICD or DSM, respectively,
these proposed rules also explain how to
determine which version is the most current as of a particular date. This serves to
provide plans and issuers with clarity on
when they would be required to begin to
rely on a new version of the ICD or DSM
after it is released, and sufficient time after
the adoption of an updated version of the
ICD or DSM to ensure that the terms of
their plan or coverage are consistent with
any changes made from the previous version. The definitions would specify that,
for purposes of compliance with these
proposed rules, the most current version
of the ICD or DSM, respectively, would
be that which is applicable no earlier than
on the date that is 1 year before the first
day of the applicable plan year.
These proposed rules also would permit plans and issuers to use a more current
version of the ICD or DSM than the version in effect 1 year before the first day
of the applicable plan year. In addition,
the Departments recognize that future
versions of the ICD or DSM may include
revisions to the categories of conditions
or disorders or chapters listed in the proposed amended definitions for “mental
health benefits” and “substance use disorder benefits,” which could affect the characterization of a benefit under MHPAEA.
Therefore, the proposed amended definitions for these two terms also refer to
“equivalent categories” and “equivalent
chapters” to help plans and issuers understand how they would apply the proposed
definitions, if finalized, and how to implement such changes if they are made in the
future. The Departments request comments on this aspect of these proposed
amended definitions.
To ensure parity between mental health
and substance use disorder benefits and

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.”

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medical/surgical benefits, it is critical that
plans and issuers define mental health
conditions and substance use disorders in
a manner consistent with the purposes of
MHPAEA. While plans and issuers have
some discretion in defining mental health
benefits and substance use disorder benefits, this discretion must be exercised in a
manner that comports with generally recognized independent standards of current
medical practice. Moreover, the proposed
amended definitions for “medical/surgical
benefits,” “mental health benefits,” and
“substance use disorder benefits” specify
that plans and issuers may use applicable State law to inform their definitions,
but only to the extent that those laws are
consistent with and do not contradict
generally recognized independent standards of current medical practice (or to
the extent these standards do not address
whether a condition or disorder is a medical condition or surgical procedure or a
mental health condition or substance use
disorder). Under both the 2013 final regulations and these proposed rules, plans
and issuers must be prepared to provide
supporting documentation to demonstrate
that the way the plan or issuer has defined
a condition or disorder for purposes of
MHPAEA is consistent with generally recognized independent standards of current
medical practice. The Departments solicit
comments on whether any additional clarification is needed on how State law may
interact with the proposed amended definitions for these key terms.
As discussed earlier in this section of
the preamble, the Departments are proposing these amendments to the definitions
of the terms “medical/surgical benefits,”
“mental health benefits,” and “substance
use disorder benefits” in part to ensure
that the use of State laws does not prevent
the application of MHPAEA’s protections
with respect to conditions or disorders that
are recognized as mental health conditions
and substance use disorders under generally recognized independent standards of
current medical practice. The Departments
recognize that States may enact various

laws for different purposes. Therefore, the
Departments are proposing to make clear
that when a plan or issuer relies upon a
State law to inform its definitions for purposes of MHPAEA, the plan or issuer must
ensure that definitions operate to apply
MHPAEA’s protections to mental health
conditions and substance use disorders, as
they are generally defined by the medical
community. The Departments also clarify
that under the proposed framework, to the
extent a State law or generally recognized
independent standards of current medical
practice define a condition or disorder as a
mental health condition or substance use
disorder, plans and issuers must treat all
benefits for the condition or disorder as
mental health benefits or substance use
disorder benefits, respectively, for purposes of analyzing parity and compliance
with MHPAEA. The Departments solicit
comments on any potential challenges of
applying MHP

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/agency%3Airs%3A683d4a7b1a692c40. Public record. Not legal advice.