Proposed Rule2023-15945
Requirements Related to the Mental Health Parity and Addiction Equity Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 3, 2023
Issuing agencies
Treasury DepartmentInternal Revenue ServiceLabor DepartmentEmployee Benefits Security AdministrationHealth and Human Services Department
Abstract
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 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).
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 148 (Thursday, August 3, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Proposed Rules]
[Pages 51552-51669]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15945]
[[Page 51551]]
Vol. 88
Thursday,
No. 148
August 3, 2023
Part III
Department of the Treasury
-----------------------------------------------------------------------
Internal Revenue Service
-----------------------------------------------------------------------
26 CFR Part 54
Department of Labor
-----------------------------------------------------------------------
Employee Benefits Security Administration
-----------------------------------------------------------------------
29 CFR Part 2590
Department of Health and Human Services
-----------------------------------------------------------------------
45 CFR Parts 146 and 147
Requirements Related to the Mental Health Parity and Addiction Equity
Act; Proposed Rule
Federal Register / Vol. 88 , No. 148 / Thursday, August 3, 2023 /
Proposed Rules
[[Page 51552]]
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG-120727-21]
RIN 1545-BQ29
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC11
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Parts 146 and 147
[CMS-9902-P]
RIN 0938-AU93
Requirements Related to the Mental Health Parity and Addiction
Equity Act
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 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):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 (<a href="http://www.dol.gov/agencies/ebsa">www.dol.gov/agencies/ebsa</a>).
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 (<a href="http://www.cms.gov/cciio">www.cms.gov/cciio</a>), and information on health
care reform can be found at <a href="http://www.Healthcare.gov">www.Healthcare.gov</a> or <a href="https://www.hhs.gov/healthcare/index.html">https://www.hhs.gov/healthcare/index.html</a>. In addition, information about mental and
behavioral health and addiction is available at <a href="https://www.samhsa.gov/mental-health">https://www.samhsa.gov/mental-health</a> and <a href="https://www.samhsa.gov/find-support">https://www.samhsa.gov/find-support</a>.
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
crisis \1\ that worsened during the COVID-19
[[Page 51553]]
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\
---------------------------------------------------------------------------
\1\ Department of Health and Human Services (2023). SAMHSA
Announces National Survey on Drug Use and Health (NSDUH) Results
Detailing Mental Illness and Substance Use Levels in 2021. Retrieved
from <a href="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">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</a>.
\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: <a href="http://dx.doi.org/10.15585/mmwr.mm7013e2">http://dx.doi.org/10.15585/mmwr.mm7013e2</a>.
\3\ Id.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\4\ Hedegaard, H., Mini[ntilde]o, A.M., Wagner, M. (2020). Drug
Overdose Deaths in the United States, 1999-2019. NCHS Data Brief No.
304 (December 2020) <a href="https://www.cdc.gov/nchs/data/databriefs/db394-H.pdf">https://www.cdc.gov/nchs/data/databriefs/db394-H.pdf</a>; Centers for Disease Control and Prevention, National Center
for Health Statistics. Vital Statistics Rapid Release: Provisional
Drug Overdose Death Counts. Available at <a href="https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm">https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm</a>. 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:
<a href="https://dx.doi.org/10.15620/cdc:102891">https://dx.doi.org/10.15620/cdc:102891</a>.
\6\ Spencer MR, Garnett MF, Mini[ntilde]o AM. Urban-rural
differences in drug overdose death rates, 2020. NCHS Data Brief, no
440. Hyattsville, MD: National Center for Health Statistics. 2022.
DOI: <a href="https://dx.doi.org/10.15620/cdc:118601">https://dx.doi.org/10.15620/cdc:118601</a>.
\7\ National Vital Statistics System. Provisional Drug Overdose
Death Counts. <a href="https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/202205.htm">https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/202205.htm</a>.
\8\ Friedman, Joseph R, and Helena Hansen (2022). Research
Letter: Evaluation of Increases in Drug Overdose Mortality Rates in
the US by Race and Ethnicity Before and During the COVID-19
Pandemic. JAMA Psychiatry. <a href="https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2789697?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamapsychiatry.2022.0004">https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2789697?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamapsychiatry.2022.0004</a>.
\9\ Id.
---------------------------------------------------------------------------
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, the highest
level reported over the past decade.\18\
---------------------------------------------------------------------------
\10\ Mental Health America (2022). Youth Ranking 2022. <a href="https://mhanational.org/issues/2022/mental-health-america-youth-data">https://mhanational.org/issues/2022/mental-health-america-youth-data</a>.
\11\ Sheridan D, Grusing S, Marshall R. (2022) Changes in
Suicidal Ingestion Among Preadolescent Children from 2000 to 2020.
JAMA Pediatrics. <a href="https://jamanetwork.com/journals/jamapediatrics/article-abstract/2789948">https://jamanetwork.com/journals/jamapediatrics/article-abstract/2789948</a>; see also CDC, Youth Risk Behavior Survey,
available at <a href="https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf">https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf</a>.
\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. <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/2680952">https://jamanetwork.com/journals/jamapediatrics/fullarticle/2680952</a>.
\13\ The Trevor Project (2022). 2022 National Survey on LGBTQ
Youth Mental Health. <a href="https://www.thetrevorproject.org/survey-2022/">https://www.thetrevorproject.org/survey-2022/</a>.
\14\ The Trevor Project (2022). The Mental Health and Well-Being
of Multiracial LGBTQ Youth. <a href="https://www.thetrevorproject.org/research-briefs/the-mental-health-and-well-being-of-multiracial-lgbtq-youth-aug-2022/">https://www.thetrevorproject.org/research-briefs/the-mental-health-and-well-being-of-multiracial-lgbtq-youth-aug-2022/</a>.
\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. <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7108e2.htm">https://www.cdc.gov/mmwr/volumes/71/wr/mm7108e2.htm</a>.
\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
<a href="https://jamanetwork.com/journals/jamapediatrics/article-abstract/2794847">https://jamanetwork.com/journals/jamapediatrics/article-abstract/2794847</a>.
\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 <a href="https://www.cdc.gov/nchhstp/newsroom/2023/increased-sadness-and-violence-press-release.html">https://www.cdc.gov/nchhstp/newsroom/2023/increased-sadness-and-violence-press-release.html</a>.
---------------------------------------------------------------------------
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\
[[Page 51554]]
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\
---------------------------------------------------------------------------
\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
<a href="https://pubmed.ncbi.nlm.nih.gov/23490450/">https://pubmed.ncbi.nlm.nih.gov/23490450/</a>.
\20\ Cf. Jack Turbin. Ghost networks of psychiatrists make money
for insurance companies but hinder patients' access to care. Stat
News, June 17, 2019, <a href="https://www.statnews.com/2019/06/17/ghost-networks-psychiatrists-hinder-patient-care/">https://www.statnews.com/2019/06/17/ghost-networks-psychiatrists-hinder-patient-care/</a>.
\21\ National Alliance on Mental Illness (2021). Mood Disorder
Survey Report. <a href="https://nami.org/NAMI/media/NAMI-Media/Research/NAMI-Mood-Disorder-Survey-White-Paper.pdf">https://nami.org/NAMI/media/NAMI-Media/Research/NAMI-Mood-Disorder-Survey-White-Paper.pdf</a>.
\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
<a href="https://www.sciencedirect.com/science/article/pii/S2772724623000227">https://www.sciencedirect.com/science/article/pii/S2772724623000227</a>.
\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 <a href="https://www.samhsa.gov/data/report/2021-nsduh-detailed-tables">https://www.samhsa.gov/data/report/2021-nsduh-detailed-tables</a>. 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 <a href="https://data.hrsa.gov/Default/GenerateHPSAQuarterlyReport">https://data.hrsa.gov/Default/GenerateHPSAQuarterlyReport</a> (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 <a href="https://www.ruralhealthresearch.org/publications/1348">https://www.ruralhealthresearch.org/publications/1348</a>.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\27\ See, generally, Commonwealth Fund, Behavioral Health Care
in the United States: How It Works and Where It Falls Short,
available at <a href="https://www.commonwealthfund.org/publications/explainer/2022/sep/behavioral-health-care-us-how-it-works-where-it-falls-short">https://www.commonwealthfund.org/publications/explainer/2022/sep/behavioral-health-care-us-how-it-works-where-it-falls-short</a>.
\28\ See National Alliance on Mental Illness, Mental Health By
the Numbers, available at <a href="https://www.nami.org/mhstats">https://www.nami.org/mhstats</a> (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 <a href="https://www.kff.org/other/report/kff-cnn-mental-health-in-america-survey/">https://www.kff.org/other/report/kff-cnn-mental-health-in-america-survey/</a> (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 <a href="https://www.chcf.org/publication/fragmented-care-harms-people-mental-illness-substance-use-disorder/">https://www.chcf.org/publication/fragmented-care-harms-people-mental-illness-substance-use-disorder/</a>.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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 <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8536951/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8536951/</a>.
\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 <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4707657/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4707657/</a>.
---------------------------------------------------------------------------
A 2019 Milliman report found a growing disparity in the utilization
of out-of-network 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 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.
---------------------------------------------------------------------------
\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. <a href="https://assets.milliman.com/ektron/Addiction_and_mental_health_vs_physical_health_Widening_disparities_in_network_use_and_provider_reimbursement.pdf">https://assets.milliman.com/ektron/Addiction_and_mental_health_vs_physical_health_Widening_disparities_in_network_use_and_provider_reimbursement.pdf</a>.
\32\ Id.
\33\ Id. at pp. 6-7.
\34\ See Busch, Susan H. and Kelly Kyanko, Assessment of
Perception of Mental Health vs. Medical Health Plan Networks Among
US Adults with Private Insurance, available at <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8536951/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8536951/</a>.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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 <a href="https://www.congress.gov/congressional-report/110th-congress/house-report/374">https://www.congress.gov/congressional-report/110th-congress/house-report/374</a>. (``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).
---------------------------------------------------------------------------
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
[[Page 51555]]
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.
---------------------------------------------------------------------------
\37\ 2022 MHPAEA Report to Congress, p. 4, available at <a href="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">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</a> and <a href="https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf">https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf</a>; 2023 MHPAEA
Comparative Analysis Report to Congress, July 2023 (2023 MHPAEA
Report to Congress), available at <a href="http://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf">www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf</a> and <a href="https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity</a>.
---------------------------------------------------------------------------
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
nationwide \39\ 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.<SUP>40 41</SUP>
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
In addition to using their enforcement authority, the Departments
continue 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\
[[Page 51556]]
fact sheets,\44\ compliance assistance tools,\45\ templates,\46\
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.
---------------------------------------------------------------------------
\42\ 78 FR 68240 (Nov. 13, 2013).
\43\ See, e.g., FAQs About Affordable Care Act Implementation
Part V and Mental Health Parity Implementation (Dec. 22, 2010),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-v.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-v.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-5">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-5</a>; FAQs About Affordable Care Act Implementation (Part VII)
and Mental Health Parity Implementation (Nov. 17, 2011), available
at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-vii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-vii.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-7">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-7</a>; Understanding Implementation of the Mental Health Parity
and Addiction Equity Act of 2008 (May 9, 2012), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/understanding-implementation-of-mhpaea.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/understanding-implementation-of-mhpaea.pdf</a>;
FAQs for Employees about the Mental Health Parity and Addiction
Equity Act (May 18, 2012), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/mhpaea-2.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/mhpaea-2.pdf</a>; FAQs About Affordable Care Act Implementation (Part
XVII) and Mental Health Parity Implementation (Nov. 8, 2013),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xvii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xvii.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-17">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-17</a>; FAQs About Affordable Care Act Implementation (Part
XVIII) and Mental Health Parity Implementation (Jan. 9, 2014),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xviii.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xviii.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-18">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-18</a>; FAQs About Affordable Care Act Implementation (Part
XXIX) and Mental Health Parity Implementation (Oct. 23, 2015),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxix.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxix.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-29">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-29</a> (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 <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-31">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-31</a>; FAQs About Affordable Care Act Implementation Part 34
and Mental Health and Substance Use Disorder Parity Implementation
(Oct. 27, 2016), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-34.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-34.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-34">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-34</a> (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 <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-38.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-38.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-38">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-set-38</a>
(FAQs Part 38); Proposed FAQs About Mental Health and Substance Use
Disorder Parity Implementation and the 21st Century Cures Act Part
39, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-39-proposed.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-39-proposed.pdf</a>
(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 <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-39-final.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-39-final.pdf</a> and <a href="https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-final-set-39">https://www.hhs.gov/guidance/document/affordable-care-act-implementation-faqs-final-set-39</a> (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 <a href="https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf</a> and <a href="https://www.hhs.gov/guidance/document/faqs-about-families-first-coronavirus-response-act-and-coronavirus-aid-relief-and-0">https://www.hhs.gov/guidance/document/faqs-about-families-first-coronavirus-response-act-and-coronavirus-aid-relief-and-0</a> (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
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-45.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-45.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/MHPAEA-FAQs-Part-45.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/MHPAEA-FAQs-Part-45.pdf</a> (FAQs Part 45); and Mental Health Parity and
Addiction Equity Act (MHPAEA) FAQs, available at <a href="https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/mhpaea-1#">https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/mhpaea-1#</a>.
\44\ See, e.g., The Mental Health Parity and Addiction Equity
Act of 2008 (MHPAEA) Fact Sheet (Jan. 2010), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea.pdf</a>; MHPAEA Enforcement Fact
Sheet (Jan. 2016), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement.pdf</a>; FY 2016 MHPAEA Enforcement Fact Sheet,
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2016.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2016.pdf</a>; FY 2017 MHPAEA Enforcement Fact Sheet, available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2017.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2017.pdf</a>;
FY 2018 MHPAEA Enforcement Fact Sheet, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2018.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/fact-sheets/mhpaea-enforcement-2018.pdf</a>; FY 2019
MHPAEA Enforcement Fact Sheet, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2019.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2019.pdf</a> and <a href="https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/mhpaea-enforcement-2019.pdf">https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/mhpaea-enforcement-2019.pdf</a>; FY 2020 MHPAEA Enforcement Fact Sheet,
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2020.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2020.pdf</a>
and <a href="https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/mhpaea-enforcement-2020.pdf">https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/mhpaea-enforcement-2020.pdf</a>; FY 2021 MHPAEA
Enforcement Fact Sheet, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2021.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2021.pdf</a>; and FY 2022 MHPAEA Enforcement Fact
Sheet, available at <a href="http://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2022.pdf">www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-enforcement-2022.pdf</a>.
\45\ See Self-Compliance Tool for Part 7 of ERISA: Health Care-
Related Provisions, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/compliance-assistance-guide-appendix-a.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/compliance-assistance-guide-appendix-a.pdf</a>; 2018 Self-Compliance
Tool for the Mental Health Parity and Addiction Equity Act (MHPAEA),
available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool-2018.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool-2018.pdf</a>;
and 2020 Self-Compliance Tool for the Mental Health Parity and
Addiction Equity Act (MHPAEA), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf</a>.
\46\ See Form to Request Documentation from an Employer-
Sponsored Health Plan or a Group or Individual Market Insurer
Concerning Treatment Limitations, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-disclosure-template.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/mhpaea-disclosure-template.pdf</a>.
\47\ See, e.g., DOL 2012 Report to Congress: Compliance With the
Mental Health Parity and Addiction Equity Act of 2008 (Jan. 1,
2012), available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/mhpaea-report-to-congress-2012.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/mhpaea-report-to-congress-2012.pdf</a>; 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 <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/mhpaea-report-to-congress-2014.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/mhpaea-report-to-congress-2014.pdf</a>; DOL 2016 Report to Congress: Improving
Healoverage 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 <a href="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">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</a>; HHS Mental Health Parity
and Addiction Equity Act of 2008 (MHPAEA) Enforcement Report (Dec.
12, 2017), available at <a href="https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/HHS-2008-MHPAEA-Enforcement-Period.pdf">https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/HHS-2008-MHPAEA-Enforcement-Period.pdf</a>; DOL 2018 Report to Congress: Pathway to Full Parity,
available at <a href="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">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</a>; 21st Century Cures Act: Section 13002
Action Plan for Enhanced Enforcement of Mental Health and Substance
Use Disorder Coverage, available at <a href="https://www.hhs.gov/sites/default/files/parity-action-plan-b.pdf">https://www.hhs.gov/sites/default/files/parity-action-plan-b.pdf</a>; HHS Mental Health Parity and
Addiction Equity Act of 2008 (MHPAEA) Enforcement Report for the
2018 Federal Fiscal Year, available at <a href="https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/FY2018-MHPAEA-Enforcement-Report.pdf">https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/FY2018-MHPAEA-Enforcement-Report.pdf</a>; DOL 2020 Report to Congress: Parity
Partnerships: Working Together, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/dol-report-to-congress-parity-partnerships-working-together.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/dol-report-to-congress-parity-partnerships-working-together.pdf</a>; 2022 Report to Congress: Realizing Parity, Reducing
Stigma, and Raising Awareness, available at <a href="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">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</a> and <a href="https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf">https://www.cms.gov/files/document/2022-mhpaea-report-congress.pdf</a>; MHPAEA Comparative Analysis Report to
Congress, July 2023, available at <a href="http://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf">www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf</a> and <a href="https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity</a>.
\48\ See Consumer Guide to Disclosure Rights: Making the Most of
Your Mental Health and Substance Use Disorder Benefits, available at
<a href="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">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</a>; Know Your
Rights: Parity for Mental Health and Substance Use Disorder
Benefits, available at <a href="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">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</a>;
Parity of Mental Health and Substance Use Benefits with Other
Benefits: Using Your Employer-Sponsored Health Plan to Cover
Services, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/parity-of-mental-health-and-substance-use-benefits-with-other-benefits.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/parity-of-mental-health-and-substance-use-benefits-with-other-benefits.pdf</a>;
Understanding Parity: A Guide to Resources for Families and
Caregivers, available at <a href="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">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</a>; Warning
Signs--Plan or Policy Non-Quantitative Treatment Limitations (NQTLs)
that Require Additional Analysis to Determine Mental Health Parity
Compliance, available at <a href="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">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</a>; Mental Health Parity Provisions Questions and
Answers, available at <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/compliance-assistance-guide-mhpaea.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/publications/compliance-assistance-guide-mhpaea.pdf</a>; Mental Health and Substance use
Disorder Parity: Compliance Assistance Materials Index, available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/compliance-assistance-materials-index.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/compliance-assistance-materials-index.pdf</a>;
The Essential Aspects of Parity: A Training Tool for Policymakers,
available at <a href="https://store.samhsa.gov/product/essential-aspects-of-parity-training-tool-for-policymakers/pep21-05-00-001">https://store.samhsa.gov/product/essential-aspects-of-parity-training-tool-for-policymakers/pep21-05-00-001</a>; and
Approaches in Implementing the Mental Health Parity and Addiction
Equity Act: Best Practices from the States, available at <a href="https://store.samhsa.gov/product/Approaches-in-Implementing-the-Mental-Health-Parity-and-Addiction-Equity-Act-Best-Practices-from-the-States/SMA16-4983">https://store.samhsa.gov/product/Approaches-in-Implementing-the-Mental-Health-Parity-and-Addiction-Equity-Act-Best-Practices-from-the-States/SMA16-4983</a>.
---------------------------------------------------------------------------
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
[[Page 51557]]
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:
<bullet> Make clear that MHPAEA requires that individuals can
access their mental health and substance use disorder benefits in
parity with medical/surgical benefits.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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 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.
---------------------------------------------------------------------------
\49\ The required classifications of benefits (and permissible
sub-classifications) used to apply the MHPAEA regulations are
addressed at 26 CFR 54.9812-1(c)(2)(ii), 29 CFR 2590.712(c)(2)(ii),
and 45 CFR 146.136(c)(2)(ii).
\50\ These proposed rules would apply directly to group health
plans or health insurance coverage offered by an issuer in
connection with a group health plan, and would apply to individual
health insurance coverage by cross-reference through 45 CFR 147.160,
which currently provides that the requirements of 45 CFR 146.136
apply to health insurance coverage offered by a health insurance
issuer in the individual market in the same manner and to the same
extent as to health insurance coverage offered by a health insurance
issuer in connection with a group health plan in the large group
market. As noted below, HHS also proposes an amendment to 45 CFR
147.160 to also include a cross-reference to proposed 45 CFR 146.137
to similarly extend the new proposed comparative analysis
requirements to individual health insurance coverage in the same
manner and to the same extent as group health insurance coverage.
For simplicity, this preamble generally refers only to the
applicability on group health plans and health insurance coverage
offered in connection with a group health plan and to participants
and beneficiaries enrolled in such a plan or coverage, but
references to participants and beneficiaries should also be
considered to include enrollees in the individual market, unless
otherwise specified.
---------------------------------------------------------------------------
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
[[Page 51558]]
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) 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\
---------------------------------------------------------------------------
\51\ Public Law 104-204, 110 Stat. 2874 (Sept. 26, 1996). The
Departments published interim final rules implementing MHPA 1996 at
62 FR 66932 (Dec. 22, 1997).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\52\ The requirements of MHPAEA generally apply to both
grandfathered and non-grandfathered health plans. See section 1251
of the Affordable Care Act and its implementing regulations at 26
CFR 54.9815-1251, 29 CFR 2590.715-1251, and 45 CFR 147.140. Under
section 1251 of the Affordable Care Act, grandfathered health plans
are exempted only from certain Affordable Care Act requirements
enacted in Subtitles A and C of Title I of the Affordable Care Act.
The provisions extending MHPAEA requirements to individual health
insurance coverage and requiring that qualified health plans comply
with MHPAEA are not included in these sections. However, because
MHPAEA requirements apply to health insurance coverage offered in
the small group market only through the requirement to provide EHB,
which does not apply to grandfathered health plans, the requirements
of MHPAEA do not apply to grandfathered health plans offered in the
small group market.
\53\ A QHP is a health insurance plan that is certified by a
health insurance exchange that it meets certain minimum standards
established under the Affordable Care Act and described in subpart C
of 45 CFR part 156. See 45 CFR 155.20.
\54\ Section 1302 of the Affordable Care Act requires non-
grandfathered health plans in the individual and small group markets
to cover essential health benefits (EHB), which include items and
services in the following ten benefit categories: (1) ambulatory
patient services; (2) emergency services; (3) hospitalization; (4)
maternity and newborn care; (5) mental health and substance use
disorder services including behavioral health treatment; (6)
prescription drugs; (7) rehabilitative and habilitative services and
devices; (8) laboratory services; (9) preventive and wellness
services and chronic disease management; and (10) pediatric
services, including oral and vision care. See 45 CFR 156.115 for
description of the benefits a health plan must provide to provide
EHB.
\55\ Section 1302(b)(1)(E) of the Affordable Care Act; 45 CFR
156.115(a)(3).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\56\ 74 FR 19155 (Apr. 28, 2009).
\57\ 75 FR 5410 (Feb. 2, 2010).
\58\ 78 FR 68240 (Nov. 13, 2013).
---------------------------------------------------------------------------
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-of-network;
outpatient, in-network; outpatient, out-of-network; emergency care; and
prescription drugs.
[[Page 51559]]
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
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.
---------------------------------------------------------------------------
\59\ Code section 9812(a)(3)(A), ERISA section 712(a)(3)(A), and
PHS Act section 2726(a)(3)(A).
\60\ With respect to aggregate lifetime and annual limits under
MHPA 1996, the regulations in 26 CFR 54.9812-1(b); 29 CFR
2590.712(b), and 45 CFR 146.136(b) set forth rules based on whether
a plan (or health insurance coverage) includes an aggregate lifetime
or annual dollar limit that applies to less than one-third or at
least two-thirds of all medical/surgical benefits. These provisions
do not address the provisions of PHS Act section 2711, as
incorporated by ERISA section 715 and Code section 9815, which
prohibit imposing lifetime and annual limits on the dollar value of
EHBs. As a result, plans and issuers cannot impose lifetime and
annual dollar limits on mental health and substance use disorder
benefits that are not EHBs, if such a limit applies to less than
one-third of all medical/surgical benefits.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\65\ See FAQs Part 34, Q4-Q9.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\66\ See FAQs Part 39, Q1-8.
---------------------------------------------------------------------------
In addition to FAQs issued after the promulgation of the 2013 final
regulations, 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
[[Page 51560]]
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\
---------------------------------------------------------------------------
\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 <a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf</a>. 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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\69\ Id. at section F (at pp. 21-28).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\70\ 2020 MHPAEA Self-Compliance Tool, at p. 21, available at
<a href="https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf">https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf</a>.
---------------------------------------------------------------------------
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.
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.
---------------------------------------------------------------------------
\71\ Public Law 116-260, 134 Stat. 1182 (Dec. 27, 2020).
\72\ Code section 9812(a)(8)(A), ERISA section 712(a)(8)(A), and
PHS Act section 2726(a)(8)(A).
\73\ Id.
---------------------------------------------------------------------------
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
[[Page 51561]]
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:
---------------------------------------------------------------------------
\74\ Code section 9812(a)(8)(B)(i), ERISA section
712(a)(8)(B)(i), and PHS Act section 2726(a)(8)(B)(i).
---------------------------------------------------------------------------
(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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 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
[[Page 51562]]
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.
---------------------------------------------------------------------------
\81\ ERISA section 712(f).
\82\ Section 203 of the CAA, 2021 (Pub. L. 116-260, 134 Stat.
1182 (Dec. 27, 2020)). In addition, the Departments were required to
send Congress an annual report on complaints and investigations
concerning compliance with the requirements of MHPAEA from 2017
until 2021. See section 13003 of the 21st Century Cures Act (Cures
Act), Public Law 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, Public Law
115-271, 132 Stat. 3894 (Oct. 24, 2018).
\83\ 2022 MHPAEA Report to Congress, available at <a href="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">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</a>.
---------------------------------------------------------------------------
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, and explores examples of
results that the Departments have achieved through enforcement.
---------------------------------------------------------------------------
\84\ 2023 MHPAEA Report to Congress, July 2023, available at
<a href="http://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf">www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2023-mhpaea-comparative-analysis.pdf</a> and <a href="https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources#mental-health-parity</a>.
---------------------------------------------------------------------------
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
[[Page 51563]]
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.
---------------------------------------------------------------------------
\85\ Office of Consumer Information and Insurance Oversight,
Amendments to the HIPAA opt-out provision (formerly section
2721(b)(2) of the Public Health Service Act) made by the Affordable
Care Act (Sept. 21, 2010), available at <a href="http://www.cms.gov/CCIIO/Resources/Files/Downloads/opt_out_memo.pdf">www.cms.gov/CCIIO/Resources/Files/Downloads/opt_out_memo.pdf</a>.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\86\ 79 FR 15808 (Mar. 21, 2014).
\87\ 79 FR 30240 (May 27, 2014).
---------------------------------------------------------------------------
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), 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\
---------------------------------------------------------------------------
\88\ Public Law 117-328, 136 Stat. 4459.
\89\ Division FF, Title I, Subtitle C, Chapter 3, sec. 1321,
Public Law 117-328, 136 Stat. 4459. As a result of the CAA, 2023
amendments to PHS Act section 2722(a)(2), self-funded, non-Federal
governmental plan sponsors may opt out of only the following three
PHS Act requirement categories: Standards relating to benefits for
newborns and mothers (PHS Act section 2725), Required coverage for
reconstructive surgery following mastectomies (PHS Act section
2727), and Coverage for dependent students on a medically necessary
leave of absence (PHS Act section 2728).
\90\ PHS Act section 2722(a)(2)(F)(i).
\91\ PHS Act section 2722(a)(2)(F)(ii).
---------------------------------------------------------------------------
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 requests \92\ to
operationalize the special rule for certain collectively bargained
plans.\93\
---------------------------------------------------------------------------
\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 <a href="https://www.cms.gov/files/document/hipaa-opt-out-bulletin.pdf">https://www.cms.gov/files/document/hipaa-opt-out-bulletin.pdf</a>.
---------------------------------------------------------------------------
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 54.9812-1, 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
[[Page 51564]]
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\
---------------------------------------------------------------------------
\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,
Public Law 117-328, 136 Stat. 4459 (Dec. 29. 2022).
---------------------------------------------------------------------------
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 54.9812-1(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 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.
---------------------------------------------------------------------------
\96\ While the Departments recognize the relevant statutory text
for dollar limits does not use the term ``predominant'' and
different rules apply, the purpose of MHPA 1996 was similar and
therefore the provisions for dollar limits should generally be read
and applied in a similar manner. See, e.g., Government
Accountability Office (GAO), Mental Health Parity Act, May 2000, at
p. 13, available at <a href="https://www.gao.gov/assets/hehs-00-95.pdf">https://www.gao.gov/assets/hehs-00-95.pdf</a> (``To
help address the discrepancies in coverage between mental and other
illnesses, the Congress passed the Mental Health Parity Act of
1996.'').
---------------------------------------------------------------------------
2. Meaning of Terms--26 CFR 54.9812-1(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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 with applicable Federal and State law, but does not include
mental health benefits or substance use disorder benefits. These
proposed rules
[[Page 51565]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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 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
[[Page 51566]]
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 MHPAEA to all benefits for a mental health condition or
substance use disorder where items and services can be delivered for
both medical conditions or surgical procedures and mental health
conditions or substance use disorders, and whether additional
clarifications or modifications to the proposed definitions are
necessary.
Interested parties also have requested that the Departments confirm
whether specific conditions are mental health conditions for purposes
of MHPAEA. Under these proposed rules, as under the existing MHPAEA
regulations and section 13007 of the Cures Act,\103\ the Departments
confirm that eating disorders, such as anorexia nervosa, bulimia
nervosa, and binge-eating disorder, are mental health conditions under
generally recognized independent standards of current medical
practice.\104\ Therefore, benefits for treatment of eating disorders
are mental health benefits for purposes of MHPAEA and may not be
defined as medical/surgical benefits under a plan or coverage.\105\
---------------------------------------------------------------------------
\103\ Section 13007 of the Cures Act states that, if a plan or
an issuer offering group or individual health insurance coverage
provides coverage for eating disorder benefits, including
residential treatment, such group health plan or health insurance
issuer shall provide such benefits consistent with the requirements
of MHPAEA.
\104\ See, e.g., Diagnostic and Statistical Manual of Mental
Disorders (5th ed.), section II, Feeding and Eating Disorders; ICD-
10, Chapter 05.
\105\ The Departments previously clarified that eating disorders
are mental health conditions, and therefore treatment of an eating
disorder is a mental health benefit, in FAQs Part 38, Q1. See DSM
(5th ed.), section II, Feeding and Eating Disorders.
---------------------------------------------------------------------------
Similarly, in response to questions from interested parties, these
proposed rules would make clear that, for purposes of MHPAEA, ASD is a
mental health condition under generally recognized independent
standards of current medical practice.\106\ Therefore, under the
proposed amended definition and framework established in these proposed
rules, if a plan or issuer generally provides benefits for ASD, ASD may
not be defined by the plan or issuer as a medical/surgical condition.
In addition, the plan or issuer may not impose any financial
requirements or treatment limitations in a classification on benefits
for ASD treatment that are more restrictive than the predominant
financial requirements or treatment limitations that apply to
substantially all medical/surgical benefits in the classification. The
plan or issuer also may not impose any financial requirements or
treatment limitations, including exclusions for Applied Behavior
Analysis (ABA) therapy (one of the primary treatments for ASD), that
are separately applicable to ASD benefits in a classification and not
to any medical/surgical benefits in the same classification. The
Departments propose to incorporate new examples illustrating the
application of MHPAEA to eating disorders and ASD, as discussed later
in this preamble. The Departments solicit comments on other specific
mental health conditions or substance use disorders that may warrant
additional clarification for purposes of analyzing parity and
compliance with MHPAEA.
---------------------------------------------------------------------------
\106\ See DSM (5th ed.), section II, Autism Spectrum Disorder.
---------------------------------------------------------------------------
In addition to the proposals outlined above to amend certain
existing definitions, these proposed rules also would add several new
definitions to codify the meaning of terms used in paragraph (c)(4)(i)
of the 2013 final regulations, which requires the processes,
strategies, evidentiary standards, and other factors used in applying
an NQTL to mental health or substance use disorder benefits to be
comparable to, and no more stringently applied than those used to apply
the NQTL to medical/surgical benefits in the same classification. These
terms and the standard were incorporated into MHPAEA's statutory
language in the amendments made by the CAA, 2021.\107\ The Departments
propose to add new definitions for the terms ``processes,''
``strategies,'' ``evidentiary standards,'' and ``factors'' to the list
of definitions for key terms proposed to be included in 26 CFR 54.9812-
1(a)(2), 29 CFR 2590.712(a)(2), and 45 CFR 146.136(a)(2) of these
proposed rules. These new definitions would provide clarity to plans
and issuers, as well as to State regulators and participants and
beneficiaries, and help facilitate compliance with the provisions of
these proposed rules related to NQTLs and the development of sufficient
comparative analyses required under the CAA, 2021 and proposed 26 CFR
54.9812-2, 29 CFR 2590.712-1, and 45 CFR 146.137. Although the
Departments have issued guidance with examples that demonstrate how
these terms apply, interested parties have stated that it can be
difficult to determine what constitutes relevant processes, strategies,
evidentiary standards, and other factors. The Departments solicit
comments on these proposed definitions, including any alternate
definitions or additional clarifications that should be considered.
---------------------------------------------------------------------------
\107\ See, e.g., Code section 9812(a)(8)(A), ERISA section
712(a)(8)(A), and PHS Act section 2726(a)(8)(A).
---------------------------------------------------------------------------
The Departments propose to add a definition of the term
``evidentiary standards'' to mean any evidence, sources, or standards
that a group health plan (or health insurance issuer offering coverage
in connection with such a plan) considered or relied upon in designing
or applying a factor with respect to an NQTL, including specific
benchmarks or thresholds. The proposed definition further provides that
evidentiary standards may be empirical, statistical, or clinical in
nature, and include sources acquired or originating from an objective
third party, such as recognized medical literature, professional
standards and
[[Page 51567]]
protocols (which may include comparative effectiveness studies and
clinical trials), published research studies, payment rates for items
and services (such as publicly available databases of the ``usual,
customary, and reasonable'' rates paid for items and services), and
clinical treatment guidelines. The proposed definition provides that
evidentiary standards would also include internal plan or issuer data,
such as claims or utilization data or criteria for assuring a
sufficient mix and number of network providers, and benchmarks or
thresholds, such as measures of excessive utilization, cost levels,
time or distance standards, or network participation percentage
thresholds.
Under these proposed rules, evidentiary standards generally would
not be considered factors, but instead would be considered or relied
upon in designing or applying a factor. Under the framework established
in the 2013 final regulations, the terms within the phrase ``processes,
strategies, evidentiary standards, and other factors'' were treated as
having overlapping meanings, and specifically, the term ``other
factors'' was treated as a catch-all. The CAA, 2021 codified in the
statute the phrase ``processes, strategies, evidentiary standards, and
other factors.'' \108\ However, the CAA, 2021 added to MHPAEA other
references to factors and evidentiary standards that indicate the
drafters meant to distinguish between factors and evidentiary
standards. For example, Code section 9812(a)(8)(A)(iii), ERISA section
712(a)(8)(A)(iii), and PHS Act 2726(a)(8)(A)(iii) refer to the
evidentiary standards that are used for the factors to determine that
an NQTL will apply to benefits, and those provisions go on to
distinguish between factors and any other sources or evidence relied
upon to design or apply an NQTL. The proposed definition of evidentiary
standards is consistent with the use of these terms by Congress in the
CAA, 2021 amendments to MHPAEA and the Departments' goal of clarifying
the meanings of these terms to help the regulated community comply with
MHPAEA's requirements. The Departments request comments on this
approach, including whether there are any circumstances under which an
evidentiary standard should also be considered a factor under these
proposed rules (such as, for example, when the plan or issuer only
relies upon a single evidentiary standard to design or apply an NQTL,
and no additional processes, strategies, or other factors).
---------------------------------------------------------------------------
\108\ Code section 9812(a)(7)(B)(ii)(II) and (8)(A)(iv), ERISA
section 712(a)(7)(B)(ii)(II) and (8)(A)(iv), and PHS Act section
2726(a)(7)(B)(ii)(II) and (8)(A)(iv).
---------------------------------------------------------------------------
The Departments also propose to clarify that the definition of the
term ``factors'' should be read broadly, so that factors are all
information, including processes and strategies (but generally not
evidentiary standards), that a group health plan (or health insurance
issuer offering coverage in connection with such a plan) considered or
relied upon to design an NQTL or used to determine whether or how the
NQTL applies to benefits under the plan or coverage. The proposed
definition of the term ``factors'' also would include information (but
generally not evidentiary standards) that the plan or issuer considered
but rejected, consistent with previous guidance on MHPAEA in the
context of the documents or plan information the Departments consider
relevant to a compliance determination.\109\ The proposed definition
also provides examples of factors, which include, but are not limited
to, provider discretion in determining diagnosis or type or length of
treatment; clinical efficacy of any proposed treatment or service;
licensing and accreditation of providers; claim types with a high
percentage of fraud; quality measures; treatment outcomes; severity or
chronicity of condition; variability in the cost of an episode of
treatment; high cost growth; variability in cost and quality;
elasticity of demand; and geographic location.
---------------------------------------------------------------------------
\109\ See FAQs Part 31, Q9, which states that a plan must
provide documents and plan information to a participant or
beneficiary, or their authorized representative, including the
specific underlying processes, strategies, evidentiary standards,
and other factors (including, but not limited to, all evidence)
considered by the plan (including factors that were relied upon and
were rejected) in determining that the NQTL will apply to a
particular mental health and substance use disorder benefit or any
medical/surgical benefits within the benefit classification at
issue.
---------------------------------------------------------------------------
Under these proposed rules, factors would include processes and
strategies, but the Departments note that there may be factors that do
not satisfy the proposed definitions of ``processes'' or
``strategies.'' By defining the term ``factor'' broadly, the
Departments intend to capture any information used to design or apply
an NQTL (other than evidentiary standards generally), regardless of
whether a plan or issuer believes that information could also be
characterized as a process or a strategy, as those terms are proposed
to be defined under these proposed rules.
Additionally, the Departments propose to define ``processes'' and
``strategies'' as types of factors, in a manner that makes clear the
differences between the two terms as they relate to the design and
application of an NQTL. Specifically, the Departments would define
``processes'' as relating to the application of an NQTL, while
``strategies'' would relate to the design of an NQTL.
The Departments therefore propose to define ``processes'' to mean
actions, steps, or procedures that a plan or issuer uses to apply an
NQTL. ``Processes'' would include requirements established by the plan
or issuer for a participant or beneficiary to access benefits,
including through actions by a participant's or beneficiary's
authorized representative, or a provider or facility. The proposed
definition further provides that processes include, but are not limited
to: procedures to submit information to authorize coverage for an item
or service prior to receiving the benefit or while treatment is ongoing
(including requirements for peer or expert clinical review of that
information); provider referral requirements; and the development and
approval of a treatment plan. The proposed definition also provides
that processes include the specific procedures used by staff or other
representatives of a plan or issuer (or the service provider of a plan
or issuer) to administer the application of NQTLs, such as: how a panel
of staff members applies the NQTL (including the qualifications of
staff involved, number of staff members allocated, and time allocated);
consultations with panels of experts in applying the NQTL; and reviewer
discretion in adhering to criteria hierarchy when applying an NQTL.
These proposed rules would define ``strategies'' as practices,
methods, or internal metrics that a plan or issuer considers, reviews,
or uses to design an NQTL. The proposed definition provides that
examples of strategies include, but are not limited to: the development
of the clinical rationale used in approving or denying benefits;
deviation from generally accepted standards of care; the selection of
information (such as from medical or clinical guidelines) deemed
reasonably necessary to make a medical necessity determination;
reliance on treatment guidelines or guidelines provided by third-party
organizations; and rationales used in selecting and adopting certain
threshold amounts, professional protocols, and fee schedules. These
proposed rules would further specify that strategies also include the
creation and composition of the staff or other representatives of a
plan or issuer (or the service provider of a plan or issuer) that
deliberates, or otherwise makes decisions, on the design of NQTLs,
including the plan's decisions related to
[[Page 51568]]
qualifications of staff involved, number of staff members allocated,
and time allocated; breadth of sources and evidence considered;
consultations with panels of experts in designing the NQTL; and the
composition of the panels used to design an NQTL.
To illustrate the interaction of the definitions of these terms, a
plan might rely on various combinations of processes, strategies,
evidentiary standards, and other factors in designing and applying a
prior authorization NQTL for in-network, non-hospital-based, inpatient/
residential facilities for non-emergency medical/surgical or mental
health or substance use disorder treatment. For example, the strategies
used by the plan to design the NQTL could include the development of
the clinical rationales the plan used in determining when to approve or
deny benefits for the facility, and the composition of the staff of the
plan that chose what information would be deemed necessary to determine
whether a participant or beneficiary has an immediate, clinically valid
need for treatment at the facility. The processes the plan used in
applying the NQTL could include the specific steps a participant or
beneficiary (or their authorized representative, including their
provider or the facility) would need to take to obtain prior
authorization, such as obtaining a written treatment plan. The
processes would also include the procedures used by staff or other
representatives of the plan (or the service provider of the plan) in
determining whether a particular request for prior authorization would
be approved. These processes and strategies would also be considered
factors, as would the licensing and accreditation requirements for non-
hospital-based, inpatient/residential facilities and the severity or
chronicity of a patient's condition when they are seeking treatment at
such a facility. Finally, the evidentiary standards used to design or
apply the factors would include, for example, the benchmarks or
thresholds the plan uses to inform the number of days of treatment at
the facility that would be authorized at one time, as well as published
research studies on the efficacy of the treatment in this particular
facility setting.
Finally, the Departments propose to amend the definition of
``treatment limitation'' to clarify that the illustrative list of NQTLs
to which the definition refers is non-exhaustive, and to amend the last
sentence to state that a complete exclusion of all benefits for a
particular condition or disorder is not a treatment limitation for
purposes of this definition. By changing the existing reference in the
definition from a ``permanent'' exclusion to a ``complete'' exclusion,
the proposed amended definition of ``treatment limitation'' would
better reflect a plan's or issuer's ability to amend the terms of their
plan or coverage and affirm that this part of the definition refers to
an exclusion of all benefits for a particular condition or disorder.
While NQTLs are generally defined as treatment limitations that are
not expressed numerically, the application of an NQTL in a numerical
way does not modify its nonquantitative character simply because the
NQTL sometimes involves numerical standards. For example, standards to
participate in a network would be NQTLs because such standards are
treatment limitations that typically are not expressed numerically.
Nevertheless, these standards sometimes rely on or involve numerical
standards, such as reimbursement rates. In this case, the numerical
expression of a reimbursement rate does not modify the nonquantitative
character of the standards related to network composition. Therefore,
such standards would still be evaluated in accordance with the rules
for NQTLs under the statute and these proposed rules.
The Departments solicit comments on all aspects of these proposed
amendments to existing definitions, as well as the new proposed
definitions. The Departments also request comment on what additional
clarifications or examples might be helpful in understanding these
amended and new proposed defined terms.
3. Nonquantitative Treatment Limitations--26 CFR 54.9812-1(c)(4), 29
CFR 2590.712(c)(4), and 45 CFR 146.136(c)(4)
As explained earlier in this preamble, the Departments are
proposing changes that are designed to prevent plans and issuers from
designing and implementing NQTLs that impose greater limits on access
to mental health and substance use disorder benefits as compared to
medical/surgical benefits. These proposed rules would add additional
requirements for plans and issuers that apply NQTLs with respect to
mental health and substance use disorder benefits, to prevent the
imposition of a greater burden on participants and beneficiaries
accessing those benefits, while preserving the ability of plans and
issuers to impose those NQTLs to the extent they are consistent with
generally recognized independent professional medical or clinical
standards or standards related to fraud, waste, and abuse. Subject to
those two narrow exceptions, these proposed rules provide that plans
and issuers would not be permitted to impose an NQTL unless (1) the
NQTL is no more restrictive as applied to mental health and substance
use disorder benefits than to medical/surgical benefits (also referred
to in this preamble as the no more restrictive requirement); \110\ (2)
the plan or issuer satisfies requirements related to the design and
application of the NQTL (also referred to in this preamble as the
design and application requirements); \111\ and (3) the plan or issuer
collects, evaluates, and considers the impact of relevant data on
access to mental health and substance use disorder benefits relative to
access to medical/surgical benefits; and subsequently takes reasonable
action as necessary to address any material differences in access shown
in the data to ensure compliance with MHPAEA (also referred to in this
preamble as the relevant data evaluation requirements).\112\
---------------------------------------------------------------------------
\110\ Proposed 26 CFR 54.9812-1(c)(4)(i), 29 CFR
2590.712(c)(4)(i), and 45 CFR 146.136(c)(4)(i).
\111\ Proposed 26 CFR 54.9812-1(c)(4)(ii), 29 CFR
2590.712(c)(4)(ii), and 45 CFR 146.136(c)(4)(ii).
\112\ Proposed 26 CFR 54.9812-1(c)(4)(iv), 29 CFR
2590.712(c)(4)(iv), and 45 CFR 146.136(c)(4)(iv).
---------------------------------------------------------------------------
The proposed rules do not require or suggest a particular sequence
to the analysis for evaluating compliance, and no inferences should be
drawn from the order in which each of these independent requirements
appear in the proposed regulatory text. For example, a plan or issuer
designing or applying an NQTL with respect to mental health or
substance use disorder benefits could begin analyzing compliance with
MHPAEA by looking at the design and application requirements under
these proposed rules before fully evaluating whether the NQTL with
respect to mental health or substance use disorder benefits complies
with the no more restrictive requirement. Additionally, if a plan or
issuer, in the process of complying with the relevant data evaluation
requirements, identifies material differences in access to mental
health and substance use disorder benefits as compared to medical/
surgical benefits, those differences would be considered a strong
indicator that the plan or issuer violated the proposed no more
restrictive requirement or the design and application
requirements.\113\ In such
[[Page 51569]]
instances, if the plan or issuer took the additional steps required
under the material differences requirement at 26 CFR 54.9812-
1(c)(4)(iv)(B), 29 CFR 2590.712(c)(4)(iv)(B), or 45 CFR
146.136(c)(4)(iv)(B) (and the special rule for NQTLs related to network
composition at 26 CFR 54.9812-1(c)(4)(iv)(C), 29 CFR
2590.712(c)(4)(iv)(C), or 45 CFR 146.136(c)(4)(iv)(C) did not apply),
then the plan or issuer would meet all three independent
requirements.\114\ The Departments solicit comments on this proposed
approach.
---------------------------------------------------------------------------
\113\ But see the special rule for NQTLs related to network
composition at proposed 26 CFR 54.9812-1(c)(4)(iv)(C), 29 CFR
2590.712(c)(4)(iv)(C), and 45 CFR 146.136(c)(4)(iv)(C), which states
that, when designing and applying one or more NQTLs related to
network composition standards, a plan fails to meet the no more
restrictive requirement and the design and application requirements,
in operation, if the relevant data show material differences in
access to in-network mental health and substance use disorder
benefits as compared to in-network medical/surgical benefits in a
classification.
\114\ The plan or issuer would also be required to document any
steps taken in accordance with the material differences requirement
(and the special rule for NQTLs related to network composition, if
applicable) as part of its comparative analyses. Even if the plan or
issuer had assessed compliance prior to the steps taken in
accordance with the material differences requirement and the special
rule for NQTLs related to network composition, the plan or issuer
would be required to re-evaluate whether the no more restrictive
requirement and the design and application requirements are met with
respect to the adjusted NQTL.
---------------------------------------------------------------------------
If a plan or issuer fails to meet any of the three requirements
with respect to an NQTL in a classification, these proposed rules state
that the NQTL would violate MHPAEA and may not be imposed on mental
health or substance use disorder benefits in the classification. Where
a plan or issuer fails to satisfy the requirements of one part of these
proposed rules for NQTLs, the plan or issuer must make changes to the
terms of the plan or coverage or the way the NQTL is designed or
applied to ensure compliance with MHPAEA.
These proposed rules also would prohibit plans and issuers from
relying upon any factor or evidentiary standard if the information,
evidence, sources, or standards on which the factor or evidentiary
standard is based discriminates against mental health or substance use
disorder benefits as compared to medical/surgical benefits.\115\
Additionally, the proposed rules would require plans and issuers to
collect and evaluate relevant outcomes data and address any material
differences in access between mental health and substance use disorder
benefits and medical/surgical benefits as necessary to ensure
compliance. This proposed provision also would impose a special rule
for NQTLs related to network composition.\116\
---------------------------------------------------------------------------
\115\ Proposed 26 CFR 54.9812-1(c)(4)(ii)(B), 29 CFR
2590.712(c)(4)(ii)(B), and 45 CFR 146.136(c)(4)(ii)(B).
\116\ Proposed 26 CFR 54.9812-1(c)(4)(iv)(C), 29 CFR
2590.712(c)(4)(iv)(C), and 45 CFR 146.136(c)(4)(iv)(C).
---------------------------------------------------------------------------
Finally, these proposed rules would make clear that a plan or
issuer that has received a final determination of noncompliance under
the comparative analysis review process established by the CAA, 2021,
including a final determination of noncompliance based on failure to
provide a sufficient comparative analysis, also could be in violation
of the substantive requirements that apply to NQTLs under MHPAEA, as
determined by the Departments. Upon such a determination, the
Departments would direct the plan or issuer to not impose the NQTL that
is the subject of the comparative analysis, unless and until the plan
or issuer can demonstrate compliance or take appropriate action to
remedy the violation.\117\ The Departments request comments on all
aspects of these proposed amendments and additions to the rules
regarding NQTLs.
---------------------------------------------------------------------------
\117\ Proposed 26 CFR 54.9812-1(c)(4)(vii), 29 CFR
2590.712(c)(4)(vii), and 45 CFR 146.136(c)(4)(vii).
---------------------------------------------------------------------------
a. Requirement That NQTLs be No More Restrictive for Mental Health and
Substance Use Disorder Benefits--26 CFR 54.9812-1(c)(4)(i), 29 CFR
2590.712(c)(4)(i), and 45 CFR 146.136(c)(4)(i)
These proposed rules, if finalized, would redesignate, from what is
currently 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i), and 45
CFR 146.136(c)(4)(i) to 26 CFR 54.9812-1(c)(4)(ii)(A), 29 CFR 2590.712
(c)(4)(ii)(A), and 45 CFR 146.136(c)(4)(ii)(A), the general rule for
evaluating NQTLs, and add new language to these paragraphs to impose
additional requirements for NQTLs. As noted elsewhere in the preamble,
these proposed rules would provide that a plan or issuer may not apply
any NQTL to mental health or substance use disorder benefits in any
classification that is more restrictive, as written or in operation,
than the predominant NQTL that applies to substantially all medical/
surgical benefits in the same classification.\118\ While the 2013 final
regulations largely relied on an analysis of the processes, strategies,
evidentiary standards, and other factors used in the application of
NQTLs, proposed 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i),
and 45 CFR 146.136(c)(4)(i) is consistent with the fundamental purpose
of MHPAEA and more closely mirrors the statutory language in Code
section 9812(a)(3)(A), ERISA section 712(a)(3)(A), and PHS Act
2726(a)(3)(A), which states that plans and issuers ``. . . shall ensure
that . . . the treatment limitations applicable to . . . mental health
or substance use disorder benefits are no more restrictive than the
predominant treatment limitations applied to substantially all medical
and surgical benefits covered by the plan ([or coverage]) . . . .''
---------------------------------------------------------------------------
\118\ As explained later in this preamble, the Departments are
also proposing to add clarifying language to these proposed rules to
make clear that any references to the term ``classifications'' in
MHPAEA's implementing regulations also includes permissible sub-
classifications, including with respect to NQTLs.
---------------------------------------------------------------------------
To that end, the proposed rules provide an explanation of how the
terms ``restrictive,'' ``substantially all,'' and ``predominant'' would
apply in the context of the no more restrictive requirement in proposed
26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i), and 45 CFR
146.136(c)(4)(i). To comply with these proposed rules, if finalized,
plans and issuers would be required to follow similar steps to those
that apply when analyzing parity with respect to financial requirements
or quantitative treatment limitations under the 2013 final regulations.
These steps would involve determining the portion of plan payments for
medical/surgical benefits subject to an NQTL in a classification;
whether the NQTL applies to substantially all medical/surgical benefits
in the classification; the predominant variation of the NQTL that
applies to medical/surgical benefits in the classification; and whether
the NQTL, as applied to mental health and substance use disorder
benefits in the classification, is more restrictive than the
predominant variation of the NQTL as applied to substantially all
medical/surgical benefits.
First, in determining whether an NQTL applies to substantially all
medical/surgical benefits in a classification, plans and issuers would
be required to determine the portion of plan payments for medical/
surgical benefits expected to be subject to the NQTL based on the
dollar amount of all plan payments for medical/surgical benefits in the
classification expected to be paid under the plan or coverage for the
plan year (or the portion of the plan year after a change in benefits
that affects the applicability of the NQTL). Similar to the
longstanding rules for financial requirements and quantitative
treatment limitations, these proposed rules would provide that for
NQTLs, any reasonable method may be used to determine the dollar amount
expected to be paid under the plan or coverage for medical/surgical
benefits. In the Departments' view, for a method to be reasonable with
respect to large group market and self-insured group health plans, a
plan or issuer would be
[[Page 51570]]
required to consider group health plan-level claims data to perform the
substantially all and predominant analyses, and must rely on such data
if it is credible to perform the required projections.\119\ Similarly,
for small group market plans, an issuer would be required to consider
``plan''-level (as opposed to the ``product''-level) claims data to
perform the substantially all analysis, using the definitions of
``plan'' and ``product'' in 45 CFR 144.103, and would be required to
rely on such data if it is credible to perform the required
projections.\120\ However, if an actuary who is subject to and meets
the qualification standards for the issuance of a statement of
actuarial opinion regarding health plans in the United States,\121\
including having the necessary education and experience to provide the
actuarial opinion, determines that a group health plan or issuer does
not have sufficient data at the plan level for a reasonable projection
of future claims costs for the ``substantially all'' analyses, the
group health plan or issuer should utilize other reasonable claims data
to make a projection to conduct actuarially-appropriate analyses. As
part of using a ``reasonable method'' to make these projections, plans
and issuers should document the assumptions used in choosing a data set
and making projections. Plans and issuers would not be required to
perform the parity analysis under proposed 26 CFR 54.9812-1(c)(4)(i),
29 CFR 2590.712 (c)(4)(i), and 45 CFR 146.136(c)(4)(i) each plan year
unless there is a change in plan benefit design or utilization that
would affect an NQTL within a classification. The Departments solicit
comments on whether there are any challenges or other considerations
with this approach regarding which level of data plans and issuers
should look to in performing this prong of the analysis, and whether
there should be a different standard given the different nature of
NQTLs.
---------------------------------------------------------------------------
\119\ See FAQs Part 34, Q3 (interpreting the reasonable method
requirement with respect to financial requirements and quantitative
treatment limits).
\120\ 45 CFR 144.103 generally defines ``product'' as a discrete
package of health insurance coverage benefits offered using a
particular product network type within a service area, and ``plan''
as the pairing of the health insurance coverage benefits under the
product with a particular cost-sharing structure, provider network,
and service area. In this context, the term ``plan'' is not
synonymous with the term ``group health plan.'' This approach would
also apply to individual health insurance coverage under HHS
regulations that incorporate the group market rules by reference.
\121\ The U.S. Qualification Standards apply to members of the
six U.S.-based organizations who issue Statements of Actuarial
Opinion in the United States. The organizations are the American
Academy of Actuaries, American Society of Pension Professionals and
Actuaries, American Society of Enrolled Actuaries, Casualty
Actuarial Society, Conference of Consulting Actuaries, and Society
of Actuaries.
---------------------------------------------------------------------------
Second, plans and issuers would be required to determine whether
the NQTL applies to substantially all medical/surgical benefits in the
classification, based on the plan payments for medical/surgical
benefits subject to an NQTL as a portion of the dollar amount of all
plan payments for medical/surgical benefits in the classification
expected to be paid under the plan for the plan year. An NQTL would be
considered to apply to substantially all medical/surgical benefits in a
classification if it applies to at least two-thirds of all medical/
surgical benefits in that classification. Whether the NQTL applies to
at least two-thirds of all medical/surgical benefits would be
determined without regard to whether the NQTL was triggered based on a
particular factor or evidentiary standard. For example, if a plan or
issuer applies a general exclusion for all benefits in a classification
that are for experimental or investigative treatment, and defines
experimental or investigative treatment to be treatments with less than
a certain number of peer-reviewed studies demonstrating efficacy, the
exclusion would be treated as applying to all of the benefits in the
classification--not just those that may be subject to the general
exclusion for experimental or investigative treatment because they lack
the requisite number of peer-reviewed studies (that is, those that
actually triggered the NQTL based on the evidentiary standard). These
proposed rules further provide that if an NQTL does not apply to at
least two-thirds of all medical/surgical benefits in a classification,
then that NQTL would not be permitted to be applied to mental health or
substance use disorder benefits in that classification.
The Departments request comment on whether any additional
clarification is needed for plans and issuers to determine whether an
NQTL applies to substantially all medical/surgical benefits in a
classification. The Departments acknowledge that there are significant
differences between financial requirements or quantitative treatment
limitations and NQTLs and therefore also request comments on whether
plans and issuers maintain systems capable of making such
determinations and the potential administrative burdens that would be
associated with such determinations. Specifically, the Departments are
interested in feedback on the approach under these proposed rules for
determining substantially all medical/surgical benefits in a
classification with respect to certain NQTLs, including those that are
used to exclude benefits under the plan or coverage (such as exclusions
for experimental or investigational treatment). The Departments also
solicit comments on the interaction of this approach with other
statutory requirements for plans and issuers prohibiting certain NQTLs
on medical/surgical benefits (such as the prohibition on prior
authorization for any minimum hospital length of stay after childbirth
under the Newborns' and Mothers' Health Protection Act \122\).
---------------------------------------------------------------------------
\122\ Code section 9811, ERISA section 711, and PHS Act sections
2725 and 2751; 26 CFR 54.9811-1, 29 CFR 2590.711, and 45 CFR 146.130
and 148.170.
---------------------------------------------------------------------------
If an NQTL applies to substantially all medical/surgical benefits
in a classification, the third step would require plans and issuers to
determine the predominant variation of the NQTL that is applied to
substantially all medical/surgical benefits subject to the NQTL in the
classification. The Departments propose that the term ``predominant''
would, for this purpose, mean the most common or most frequent
variation of an NQTL within a benefit classification. For example, if a
plan applies inpatient concurrent review commencing 1 day, 3 days, or 7
days after admission, depending on the reason for a stay in a hospital
or other inpatient facility, or the procedure performed during such a
stay, the plan imposes three different variations of the NQTL within
the benefit classification. Under this example, to determine which
variation is predominant, the plan would determine the portion of
inpatient benefits subject to each of the three different variations of
the NQTL based on the dollar amount of all plan payments expected to be
paid under the plan or coverage for the plan year (or the portion of
the plan year after a change in benefits that affects the applicability
of the NQTL). Similarly, if a plan applies an NQTL such as prior
authorization in a manner that differs based on the manner of review
(auto-adjudication vs. manual review) and the number of levels of
review (first-level review vs. first-level review and peer-to-peer
review), the plan would regard each unique combination as a separate
variation. If the plan or issuer imposes only one variation of an NQTL,
that variation is considered the predominant NQTL for purposes of the
no more restrictive requirement.
Variations of an NQTL for purposes of the determination of which is
[[Page 51571]]
``predominant'' are different than levels of a type of financial
requirement or quantitative treatment limitation. Because of the nature
of NQTLs, the same mathematical principles for combining plan payments
to get to more than one-half for a financial requirement or
quantitative treatment limitation may not always be transferrable when
determining which variation of an NQTL is predominant. Therefore, for
purposes of NQTLs, the ``predominant'' variation would be the most
common or frequent variation of the NQTL. The most common or frequent
variation would be the variation that applies to the highest portion of
all medical/surgical benefits within a classification that are subject
to the NQTL based on expected plan payments. This proposed definition
mirrors the statutory definition of the term ``predominant'' in Code
section 9812(a)(3)(B)(ii), ERISA section 712(a)(3)(B)(ii), and PHS Act
section 2726(a)(3)(B)(ii). However, it is different in some ways from
the 2013 final regulations for financial requirements and quantitative
treatment limitations, because the distinct nature of NQTLs
necessitates looking to the most common or frequent variation rather
than comparing and combining numerical levels. Using the inpatient
concurrent review example described earlier in this section of the
preamble, if the plan had determined that applying concurrent review 7
days after admission was the predominant variation, the plan would be
prohibited from applying a more restrictive variation of that NQTL to
mental health or substance use disorder benefits in the classification.
The Departments request comment on this approach and any additional
clarifications or specificity that is necessary for plans and issuers
to determine the predominant NQTL that applies to substantially all
medical/surgical benefits in a classification, including what
characteristics of a particular NQTL should be considered when
determining the predominant variation when a plan or issuer imposes
multiple variations, and how to distinguish between what might be a
single NQTL without any variations versus what might be variations of a
single NQTL. The Departments also request comment on what should be
considered the predominant variation of an NQTL when multiple
variations are equally common or frequent. Additionally, the
Departments are interested in alternative approaches to determining the
predominant variation of an NQTL that would provide clarity across a
wide variety of NQTLs and ways that plans and issuers design and apply
NQTLs to various types of benefits.
Fourth, under these proposed rules, an NQTL applied to mental
health or substance use disorder benefits cannot be more restrictive
than the predominant NQTL applied to substantially all medical/surgical
benefits in the same classification. An NQTL is restrictive if it
imposes conditions, terms, or requirements that limit access to
benefits under the terms of the plan or coverage. For purposes of
determining whether an NQTL is restrictive, ``conditions, terms, or
requirements'' would include, but would not be limited to, those that
compel an action by or on behalf of a participant or beneficiary
(including by their authorized representative or a provider or
facility) to access benefits and those that limit access to the full
range of treatment options available for a condition or disorder under
the plan or coverage. Thus, if an NQTL applied to mental health or
substance use disorder benefits is determined to be more restrictive,
as written or in operation, than the predominant NQTL applied to
substantially all medical/surgical benefits in the same classification,
the NQTL would violate MHPAEA, subject to certain exceptions for
independent professional medical or clinical standards and standards
related to fraud, waste, and abuse, discussed in more detail later in
this preamble.
The Departments recognize that the term ``restrictive'' is not
specifically defined in MHPAEA or the 2013 final regulations in the
context of the parity analysis for financial requirements and
quantitative treatment limitations. The Departments are of the view
that it is generally apparent when one financial requirement or
quantitative treatment limitation is more restrictive than another. For
example, a $25 copayment is clearly more restrictive than a $15
copayment, and a 5-visit limit is more restrictive than a 10-visit
limit. However, due to the nature of NQTLs, which generally do not
allow for such straightforward comparison, and the fact that many plans
and issuers have designed and applied NQTLs to mental health and
substance use disorder benefits in a manner that limits access to those
benefits as compared to medical/surgical benefits, the Departments are
proposing a definition of ``restrictive'' to clarify how this term
should be interpreted specifically for NQTLs in a manner that is
consistent with MHPAEA's fundamental purpose. The Departments solicit
comments on any additional clarifications necessary for plans and
issuers to apply the no more restrictive requirement with respect to
NQTLs applicable to mental health and substance use disorder benefits.
The Departments also solicit comments on whether there are any specific
NQTLs for which it would be challenging for plans and issuers to
determine whether the NQTL is more restrictive with respect to mental
health and substance use disorder benefits than medical/surgical
benefits, consistent with the proposed definition of ``restrictive.''
The following example applies each of the steps in the analysis
described earlier in this preamble for the proposed no more restrictive
requirement at 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i), and
45 CFR 146.136(c)(4)(i). Under this example, a self-insured group
health plan imposes a medical management requirement that all
inpatient, in-network medical/surgical and mental health and substance
use disorder facilities have 24-hour onsite nursing services available.
First, the plan would determine the portion of plan payments for
medical/surgical benefits that are subject to the NQTL, based on the
dollar amount of all plan payments for medical/surgical benefits in the
inpatient, in-network classification expected to be paid under the plan
for the plan year. Second, based on this calculation, the plan would
determine whether the NQTL applies to at least two-thirds of inpatient,
in-network medical/surgical benefits. Because all medical/surgical
benefits in the classification are subject to the medical management
requirement, the NQTL would apply to substantially all medical/surgical
benefits in the classification. Third, the plan would identify the
predominant, or most common or frequent, variation of the NQTL based on
the portion of plan payments for medical/surgical benefits that are
subject to each variation of the NQTL. In this case, because there is
only one variation (the requirement that facilities have 24-hour on-
site nursing services available), that variation of the NQTL would be
predominant under the framework in these proposed rules. Finally, the
plan would evaluate whether the NQTL as applied to mental health and
substance use disorder benefits is more restrictive, as written or in
operation, than the predominant NQTL applicable to substantially all
medical/surgical benefits in the inpatient, in-network classification.
Because the requirement that facilities have 24-hour on-site nursing
services available does not impose additional conditions, terms, or
requirements that
[[Page 51572]]
limit access to benefits under the terms of the plan or coverage for
mental health or substance use disorder benefits as compared to
medical/surgical benefits by, for example, compelling an additional
action by a participant or beneficiary to access mental health and
substance use disorder benefits or limiting access to the full range of
treatment options available, for mental health or substance use
disorder benefits as compared to medical/surgical benefits in the
classification, this NQTL would satisfy the no more restrictive
requirement under 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i),
and 45 CFR 146.136(c)(4)(i) of these proposed rules.
If a plan or issuer analyzes an NQTL and determines that it
satisfies the no more restrictive requirement under these proposed
rules, it would also still be required under these proposed rules to
analyze the NQTL under the design and application requirements and the
relevant data evaluation requirements, discussed later in this
preamble, to ensure compliance with MHPAEA. As discussed earlier in
this preamble, the Departments note that, while the no more restrictive
requirement appears first in these proposed rules, nothing in these
proposed rules is intended to require that compliance with the no more
restrictive requirement be assessed before the other requirements for
NQTLs in proposed 26 CFR 54.9812-1(c)(4), 29 CFR 2590.712(c)(4), and 45
CFR 146.136(c)(4). The Departments propose adding several examples,
described later in this preamble, to illustrate how the no more
restrictive requirement, the design and application requirements, and
the relevant data evaluation requirements in these proposed rules apply
to various factual scenarios.
Under these proposed rules, the Departments do not intend to
interfere with a plan's or issuer's attempts to ensure that coverage
for benefits for the treatment of mental health conditions and
substance use disorders is consistent with generally accepted
independent professional medical or clinical standards. Similarly, the
Departments do not intend for the no more restrictive requirement to
prevent plans and issuers from applying reasonably designed and
carefully circumscribed measures adopted for the purpose of detecting
or preventing and proving fraud, waste, and abuse. The Departments
recognize that the application of independent professional medical or
clinical standards and standards related to fraud, waste, and abuse
generally improve and help to ensure appropriate care for participants
and beneficiaries, rather than restrict access to needed benefits. The
Departments also acknowledge that there are instances in which the
application of independent professional medical or clinical standards
might result in plans and issuers applying NQTLs to mental health or
substance use disorder benefits that would otherwise be more
restrictive than the predominant NQTL applied to substantially all
medical/surgical benefits in the same classification when applying the
no more restrictive requirement in proposed 26 CFR 54.9812-
1(c)(4)(i)(A) through (D), 29 CFR 2590.712(c)(4)(i)(A) through (D), and
45 CFR 146.136(c)(4)(i)(A) through (D). Therefore, the Departments
propose that an NQTL applied to mental health or substance use disorder
benefits in any classification would not be considered to violate the
no more restrictive requirement if the NQTL impartially applies
independent professional medical or clinical standards or applies
standards related to fraud, waste, and abuse, that meet specific
requirements, discussed in more detail later in this preamble.
b. Requirements Related to Design and Application of the NQTL--26 CFR
54.9812-1(c)(4)(ii), 29 CFR 2590.712(c)(4)(ii), and 45 CFR
146.136(c)(4)(ii)
As mentioned earlier in this preamble, these proposed rules would
redesignate the requirement currently in 26 CFR 54.9812-1(c)(4)(i), 29
CFR 2590.712(c)(4)(i), and 45 CFR 146.136(c)(4)(i) as paragraph
(c)(4)(ii)(A) and would amend the requirement codified in the 2013
final regulations to align with the Departments' consistent
interpretation that a plan or issuer may not impose an NQTL with
respect to mental health or substance use disorder benefits in any
classification unless, under the terms of the plan (or health insurance
coverage) as written and in operation, any processes, strategies,
evidentiary standards, or other factors used in designing and applying
the NQTL to mental health or substance use disorder benefits in the
classification are comparable to, and are applied no more stringently
than, the processes, strategies, evidentiary standards, or other
factors used in designing and applying the limitation with respect to
medical/surgical benefits in the classification. To codify this
interpretation, and for consistency with statutory language added by
the CAA, 2021, the Departments propose to revise the regulatory text to
make this requirement explicit.
Under these proposed rules, a key consideration in determining
whether, in designing or applying an NQTL to mental health or substance
use disorder benefits, the processes, strategies, evidentiary
standards, or other factors are applied no more stringently than those
used in designing and applying the limitation to medical/surgical
benefits in the classification, would be whether any process, strategy,
evidentiary standard, or other factor restricts access more so to
mental health or substance use disorder benefits than to generally
comparable medical/surgical benefits. This approach is consistent with
the proposed new purpose section set forth in these proposed rules and
discussed earlier in this preamble.
Under these proposed rules, if a plan or issuer imposes an NQTL
that impartially applies independent professional medical or clinical
standards to medical/surgical benefits and mental health or substance
use disorder benefits that would not be considered a violation of the
no more restrictive requirement or the relevant data evaluation
requirements. However, the plan or issuer would still need to comply
with the design and application requirements in proposed 26 CFR
54.49812-1(c)(4)(ii)(A), 29 CFR 2590.712(c)(4)(ii)(A), and 45 CFR
146.136(c)(4)(ii)(A). That is, the plan or issuer would not be
permitted to impose an NQTL with respect to mental health or substance
use disorder benefits in any classification unless, under the terms of
the plan (or health insurance coverage) as written and in operation,
any processes, strategies, evidentiary standards, or other factors used
in designing and applying the NQTL to mental health or substance use
disorder benefits in the classification are comparable to, and are
applied no more stringently than those used in designing and applying
the NQTL with respect to medical/surgical benefits in the
classification. Similarly, if a plan or issuer imposes standards
related to fraud, waste, and abuse in a manner described in the
proposed rules, the plan or issuer would still be required to comply
with the design and application requirements and the relevant data
evaluation requirements in proposed 26 CFR 54.49812-1(c)(4)(ii) and
(iv), 29 CFR 2590.712(c)(4)(ii) and (iv), and 45 CFR 146.136(c)(4)(ii)
and (iv).
The Departments also propose to add a new provision to further
ensure that processes, strategies, evidentiary standards, and other
factors used in designing and applying an NQTL to mental health or
substance use disorder benefits in a classification are comparable to,
and are applied no more stringently than, those used in designing
[[Page 51573]]
and applying an NQTL to medical/surgical benefits in the same
classification. Specifically, for purposes of determining comparability
and stringency under the design and application requirements of 26 CFR
54.49812-1(c)(4)(ii)(A), 29 CFR 2590.712(c)(4)(ii)(A), and 45 CFR
146.136(c)(4)(ii)(A), these proposed rules would prohibit plans and
issuers from relying upon any factor or evidentiary standard if the
information, evidence, sources, or standards on which the factor or
evidentiary standard is based discriminates against mental health or
substance use disorder benefits as compared to medical/surgical
benefits. Various factors and evidentiary standards that plans and
issuers have previously relied on, or currently rely on, to design or
apply NQTLs to mental health or substance use disorder benefits might
themselves discriminate against mental health and substance use
disorder benefits by treating them in a different and less favorable
manner. Consistent with MHPAEA's fundamental purpose, the Departments
are of the view that plans and issuers should not be permitted to rely
on such factors or evidentiary standards to design and apply an NQTL if
the information, evidence, sources, or standards on which the factor or
evidentiary standard is based discriminates against mental health and
substance use disorder benefits as compared to medical/surgical
benefits. These proposed rules establish this requirement as a
threshold component of the analysis that a plan or issuer would be
required to undertake when analyzing an NQTL's compliance with the
design and application requirements under these proposed rules.\123\
---------------------------------------------------------------------------
\123\ The Departments note that the prohibition on
discriminatory factors and evidentiary standards in proposed 26 CFR
54.49812-1(c)(4)(ii)(B), 29 CFR 2590.712(c)(4)(ii)(B), and 45 CFR
146.136(c)(4)(ii)(B) is not intended to affect the application of
any other Federal or State laws for other purposes, and solicit
comments on any potential interactions with other such laws that may
warrant additional clarification.
---------------------------------------------------------------------------
For purposes of these proposed rules, independent professional
medical or clinical standards described in proposed 26 CFR 54.49812-
1(c)(4)(v)(A), 29 CFR 2590.712(c)(4)(v)(A), and 45 CFR
146.136(c)(4)(v)(A) would not be considered to discriminate against
mental health or substance use disorder benefits, consistent with the
exceptions to other requirements for NQTLs in described elsewhere in
this preamble. Similarly, standards related to fraud, waste, and abuse
under proposed 26 CFR 54.49812-1(c)(4)(v)(B), 29 CFR
2590.712(c)(4)(v)(B), and 45 CFR 146.136(c)(4)(v)(B) would also not be
considered to discriminate against mental health or substance use
disorder benefits. The Departments request comments on this approach.
The Departments also solicit comments on any additional clarifications
necessary for plans and issuers to apply this standard with respect to
NQTLs applicable to mental health and substance use disorder benefits,
as the term ``discriminate'' is proposed to be defined in these
proposed rules.
Under these proposed rules, information is considered to
discriminate against mental health or substance use disorder benefits
if it is biased or not objective, in a manner that results in less
favorable treatment of mental health or substance use disorder
benefits, based on all the relevant facts and circumstances. Such
relevant facts and circumstances include, but are not limited to, the
source of the information, the purpose or context of the information,
and the content of the information. Therefore, plans and issuers would
not be permitted to rely on information that reflects bias, as those
factors or evidentiary standards would be discriminatory under these
proposed rules. For this purpose, the Departments are of the view that
information that results in the less favorable treatment of mental
health and substance use disorder benefits without legitimate
justification or that is otherwise not objective would be considered to
be biased and to discriminate against mental health and substance use
disorder benefits. Under these proposed rules, the determination of
whether information is objective and unbiased would be based on all the
relevant facts and circumstances including, but not limited to, the
source of the information, the purpose or context of the information,
and the content of the information. When determining which information,
evidence, sources, or standards should inform the factors or
evidentiary standards used to design or apply an NQTL, plans and
issuers would not be permitted under these proposed rules to use
information, evidence, sources, or standards if they are biased in
favor of imposing greater restrictions on access to covered mental
health and substance use disorder benefits or not objective, based on
all the relevant facts and circumstances.
More specifically, the proposed rules would prohibit plans and
issuers from relying on historical plan data or other historical
information from a time when the plan or coverage was not subject to
MHPAEA or was in violation of MHPAEA's requirements where the use of
such data results in less favorable treatment of mental health and
substance use disorder benefits. As an example, under these proposed
rules, a plan or issuer would not be permitted to calculate
reimbursement rates based on historical data on total plan spending for
each specialty that is divided between mental health and substance use
disorder providers and medical/surgical providers, when the total
spending by the plan was based on a time period when the plan or
coverage was not subject to MHPAEA or was in violation of MHPAEA, if
the data results in less favorable treatment of mental health and
substance use disorder
[…truncated; see source link]Indexed from Federal Register on August 3, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.