[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7539 Reported in House (RH)]
<DOC>
Union Calendar No. 575
116th CONGRESS
2d Session
H. R. 7539
[Report No. 116-692, Part I]
To strengthen parity in mental health and substance use disorder
benefits.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 9, 2020
Mr. Kennedy (for himself, Ms. Porter, Mr. Bilirakis, and Mr. Upton)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Ways and
Means, and Education and Labor, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
December 24, 2020
Additional sponsors: Mr. Lujan, Mr. Soto, and Mr. Fitzpatrick
December 24, 2020
Reported from the Committee on Energy and Commerce with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
December 24, 2020
Committees on Ways and Means and Education and Labor discharged;
committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on July 9,
2020]
_______________________________________________________________________
A BILL
To strengthen parity in mental health and substance use disorder
benefits.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Strengthening Behavioral Health
Parity Act''.
SEC. 2. STRENGTHENING PARITY IN MENTAL HEALTH AND SUBSTANCE USE
DISORDER BENEFITS.
(a) PHSA.--
(1) In general.--Title XXVII of the Public Health Service
Act (42 U.S.C. 300gg-11 et seq.) is amended by adding at the
end the following new part:
``PART D--ADDITIONAL COVERAGE PROVISIONS
``SEC. 2799A-1. PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER
BENEFITS.
``(a) In General.--
``(1) Aggregate lifetime limits.--In the case of a group
health plan or a health insurance issuer offering group or
individual health insurance coverage that provides both medical
and surgical benefits and mental health or substance use
disorder benefits--
``(A) No lifetime limit.--If the plan or coverage
does not include an aggregate lifetime limit on
substantially all medical and surgical benefits, the
plan or coverage may not impose any aggregate lifetime
limit on mental health or substance use disorder
benefits.
``(B) Lifetime limit.--If the plan or coverage
includes an aggregate lifetime limit on substantially
all medical and surgical benefits (in this paragraph
referred to as the `applicable lifetime limit'), the
plan or coverage shall either--
``(i) apply the applicable lifetime limit
both to the medical and surgical benefits to
which it otherwise would apply and to mental
health and substance use disorder benefits and
not distinguish in the application of such
limit between such medical and surgical
benefits and mental health and substance use
disorder benefits; or
``(ii) not include any aggregate lifetime
limit on mental health or substance use
disorder benefits that is less than the
applicable lifetime limit.
``(C) Rule in case of different limits.--In the
case of a plan or coverage that is not described in
subparagraph (A) or (B) and that includes no or
different aggregate lifetime limits on different
categories of medical and surgical benefits, the
Secretary shall establish rules under which
subparagraph (B) is applied to such plan or coverage
with respect to mental health and substance use
disorder benefits by substituting for the applicable
lifetime limit an average aggregate lifetime limit that
is computed taking into account the weighted average of
the aggregate lifetime limits applicable to such
categories.
``(2) Annual limits.--In the case of a group health plan or
a health insurance issuer offering group or individual health
insurance coverage that provides both medical and surgical
benefits and mental health or substance use disorder benefits--
``(A) No annual limit.--If the plan or coverage
does not include an annual limit on substantially all
medical and surgical benefits, the plan or coverage may
not impose any annual limit on mental health or
substance use disorder benefits.
``(B) Annual limit.--If the plan or coverage
includes an annual limit on substantially all medical
and surgical benefits (in this paragraph referred to as
the `applicable annual limit'), the plan or coverage
shall either--
``(i) apply the applicable annual limit
both to medical and surgical benefits to which
it otherwise would apply and to mental health
and substance use disorder benefits and not
distinguish in the application of such limit
between such medical and surgical benefits and
mental health and substance use disorder
benefits; or
``(ii) not include any annual limit on
mental health or substance use disorder
benefits that is less than the applicable
annual limit.
``(C) Rule in case of different limits.--In the
case of a plan or coverage that is not described in
subparagraph (A) or (B) and that includes no or
different annual limits on different categories of
medical and surgical benefits, the Secretary shall
establish rules under which subparagraph (B) is applied
to such plan or coverage with respect to mental health
and substance use disorder benefits by substituting for
the applicable annual limit an average annual limit
that is computed taking into account the weighted
average of the annual limits applicable to such
categories.
``(3) Financial requirements and treatment limitations.--
``(A) In general.--In the case of a group health
plan or a health insurance issuer offering group or
individual health insurance coverage that provides both
medical and surgical benefits and mental health or
substance use disorder benefits, such plan or coverage
shall ensure that--
``(i) the financial requirements applicable
to such mental health or substance use disorder
benefits are no more restrictive than the
predominant financial requirements applied to
substantially all medical and surgical benefits
covered by the plan (or coverage), and there
are no separate cost sharing requirements that
are applicable only with respect to mental
health or substance use disorder benefits; and
``(ii) the treatment limitations applicable
to such 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) and there are
no separate treatment limitations that are
applicable only with respect to mental health
or substance use disorder benefits.
``(B) Definitions.--In this paragraph:
``(i) Financial requirement.--The term
`financial requirement' includes deductibles,
copayments, coinsurance, and out-of-pocket
expenses, but excludes an aggregate lifetime
limit and an annual limit subject to paragraphs
(1) and (2).
``(ii) Predominant.--A financial
requirement or treatment limit is considered to
be predominant if it is the most common or
frequent of such type of limit or requirement.
``(iii) Treatment limitation.--The term
`treatment limitation' includes limits on the
frequency of treatment, number of visits, days
of coverage, or other similar limits on the
scope or duration of treatment.
``(4) Availability of plan information.--The criteria for
medical necessity determinations made under the plan with
respect to mental health or substance use disorder benefits (or
the health insurance coverage offered in connection with the
plan with respect to such benefits) shall be made available by
the plan administrator (or the health insurance issuer offering
such coverage) in accordance with regulations to any current or
potential participant, beneficiary, or contracting provider
upon request. The reason for any denial under the plan (or
coverage) of reimbursement or payment for services with respect
to mental health or substance use disorder benefits in the case
of any participant or beneficiary shall, on request or as
otherwise required, be made available by the plan administrator
(or the health insurance issuer offering such coverage) to the
participant or beneficiary in accordance with regulations.
``(5) Out-of-network providers.--In the case of a plan or
coverage that provides both medical and surgical benefits and
mental health or substance use disorder benefits, if the plan
or coverage provides coverage for medical or surgical benefits
provided by out-of-network providers, the plan or coverage
shall provide coverage for mental health or substance use
disorder benefits provided by out-of-network providers in a
manner that is consistent with the requirements of this
section.
``(6) Compliance program guidance document.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Labor, and the Secretary of the Treasury,
in consultation with the Inspector General of the
Department of Health and Human Services, the Inspector
General of the Department of Labor, and the Inspector
General of the Department of the Treasury, shall issue
a compliance program guidance document to help improve
compliance with this section, section 712 of the
Employee Retirement Income Security Act of 1974, and
section 9812 of the Internal Revenue Code of 1986, as
applicable. In carrying out this paragraph, the
Secretaries may take into consideration the 2016
publication of the Department of Health and Human
Services and the Department of Labor, entitled `Warning
Signs - Plan or Policy Non-Quantitative Treatment
Limitations (NQTLs) that Require Additional Analysis to
Determine Mental Health Parity Compliance'.
``(B) Examples illustrating compliance and
noncompliance.--
``(i) In general.--The compliance program
guidance document required under this paragraph
shall provide illustrative, de-identified
examples (that do not disclose any protected
health information or individually identifiable
information) of previous findings of compliance
and noncompliance with this section, section
712 of the Employee Retirement Income Security
Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable, based on
investigations of violations of such sections,
including--
``(I) examples illustrating
requirements for information
disclosures and nonquantitative
treatment limitations; and
``(II) descriptions of the
violations uncovered during the course
of such investigations.
``(ii) Nonquantitative treatment
limitations.--To the extent that any example
described in clause (i) involves a finding of
compliance or noncompliance with regard to any
requirement for nonquantitative treatment
limitations, the example shall provide
sufficient detail to fully explain such
finding, including a full description of the
criteria involved for approving medical and
surgical benefits and the criteria involved for
approving mental health and substance use
disorder benefits.
``(iii) Access to additional information
regarding compliance.--In developing and
issuing the compliance program guidance
document required under this paragraph, the
Secretaries specified in subparagraph (A)--
``(I) shall enter into interagency
agreements with the Inspector General
of the Department of Health and Human
Services, the Inspector General of the
Department of Labor, and the Inspector
General of the Department of the
Treasury to share findings of
compliance and noncompliance with this
section, section 712 of the Employee
Retirement Income Security Act of 1974,
or section 9812 of the Internal Revenue
Code of 1986, as applicable; and
``(II) shall seek to enter into an
agreement with a State to share
information on findings of compliance
and noncompliance with this section,
section 712 of the Employee Retirement
Income Security Act of 1974, or section
9812 of the Internal Revenue Code of
1986, as applicable.
``(C) Recommendations.--The compliance program
guidance document shall include recommendations to
advance compliance with this section, section 712 of
the Employee Retirement Income Security Act of 1974, or
section 9812 of the Internal Revenue Code of 1986, as
applicable, and encourage the development and use of
internal controls to monitor adherence to applicable
statutes, regulations, and program requirements. Such
internal controls may include illustrative examples of
nonquantitative treatment limitations on mental health
and substance use disorder benefits, which may fail to
comply with this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section 9812
of the Internal Revenue Code of 1986, as applicable, in
relation to nonquantitative treatment limitations on
medical and surgical benefits.
``(D) Updating the compliance program guidance
document.--The Secretary, the Secretary of Labor, and
the Secretary of the Treasury, in consultation with the
Inspector General of the Department of Health and Human
Services, the Inspector General of the Department of
Labor, and the Inspector General of the Department of
the Treasury, shall update the compliance program
guidance document every 2 years to include
illustrative, de-identified examples (that do not
disclose any protected health information or
individually identifiable information) of previous
findings of compliance and noncompliance with this
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable.
``(7) Additional guidance.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Labor, and the Secretary of the Treasury
shall issue guidance to group health plans and health
insurance issuers offering group or individual health
insurance coverage to assist such plans and issuers in
satisfying the requirements of this section, section
712 of the Employee Retirement Income Security Act of
1974, or section 9812 of the Internal Revenue Code of
1986, as applicable.
``(B) Disclosure.--
``(i) Guidance for plans and issuers.--The
guidance issued under this paragraph shall
include clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or
individual health insurance coverage may use
for disclosing information to ensure compliance
with the requirements under this section,
section 712 of the Employee Retirement Income
Security Act of 1974, or section 9812 of the
Internal Revenue Code of 1986, as applicable,
(and any regulations promulgated pursuant to
such sections, as applicable).
``(ii) Documents for participants,
beneficiaries, contracting providers, or
authorized representatives.--The guidance
issued under this paragraph shall include
clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or
individual health insurance coverage may use to
provide any participant, beneficiary,
contracting provider, or authorized
representative, as applicable, with documents
containing information that the health plans or
issuers are required to disclose to
participants, beneficiaries, contracting
providers, or authorized representatives to
ensure compliance with this section, section
712 of the Employee Retirement Income Security
Act of 1974, or section 9812 of the Internal
Revenue Code of 1986, as applicable, compliance
with any regulation issued pursuant to such
respective section, or compliance with any
other applicable law or regulation. Such
guidance shall include information that is
comparative in nature with respect to--
``(I) nonquantitative treatment
limitations for both medical and
surgical benefits and mental health and
substance use disorder benefits;
``(II) the processes, strategies,
evidentiary standards, and other
factors used to apply the limitations
described in subclause (I); and
``(III) the application of the
limitations described in subclause (I)
to ensure that such limitations are
applied in parity with respect to both
medical and surgical benefits and
mental health and substance use
disorder benefits.
``(C) Nonquantitative treatment limitations.--The
guidance issued under this paragraph shall include
clarifying information and illustrative examples of
methods, processes, strategies, evidentiary standards,
and other factors that group health plans and health
insurance issuers offering group or individual health
insurance coverage may use regarding the development
and application of nonquantitative treatment
limitations to ensure compliance with this section,
section 712 of the Employee Retirement Income Security
Act of 1974, or section 9812 of the Internal Revenue
Code of 1986, as applicable, (and any regulations
promulgated pursuant to such respective section),
including--
``(i) examples of methods of determining
appropriate types of nonquantitative treatment
limitations with respect to both medical and
surgical benefits and mental health and
substance use disorder benefits, including
nonquantitative treatment limitations
pertaining to--
``(I) medical management standards
based on medical necessity or
appropriateness, or whether a treatment
is experimental or investigative;
``(II) limitations with respect to
prescription drug formulary design; and
``(III) use of fail-first or step
therapy protocols;
``(ii) examples of methods of determining--
``(I) network admission standards
(such as credentialing); and
``(II) factors used in provider
reimbursement methodologies (such as
service type, geographic market, demand
for services, and provider supply,
practice size, training, experience,
and licensure) as such factors apply to
network adequacy;
``(iii) examples of sources of information
that may serve as evidentiary standards for the
purposes of making determinations regarding the
development and application of nonquantitative
treatment limitations;
``(iv) examples of specific factors, and
the evidentiary standards used to evaluate such
factors, used by such plans or issuers in
performing a nonquantitative treatment
limitation analysis;
``(v) examples of how specific evidentiary
standards may be used to determine whether
treatments are considered experimental or
investigative;
``(vi) examples of how specific evidentiary
standards may be applied to each service
category or classification of benefits;
``(vii) examples of methods of reaching
appropriate coverage determinations for new
mental health or substance use disorder
treatments, such as evidence-based early
intervention programs for individuals with a
serious mental illness and types of medical
management techniques;
``(viii) examples of methods of reaching
appropriate coverage determinations for which
there is an indirect relationship between the
covered mental health or substance use disorder
benefit and a traditional covered medical and
surgical benefit, such as residential treatment
or hospitalizations involving voluntary or
involuntary commitment; and
``(ix) additional illustrative examples of
methods, processes, strategies, evidentiary
standards, and other factors for which the
Secretary determines that additional guidance
is necessary to improve compliance with this
section, section 712 of the Employee Retirement
Income Security Act of 1974, or section 9812 of
the Internal Revenue Code of 1986, as
applicable.
``(D) Public comment.--Prior to issuing any final
guidance under this paragraph, the Secretary shall
provide a public comment period of not less than 60
days during which any member of the public may provide
comments on a draft of the guidance.
``(8) Compliance requirements.--
``(A) Nonquantitative treatment limitation (nqtl)
requirements.--In the case of a group health plan or a
health insurance issuer offering group or individual
health insurance coverage that provides both medical
and surgical benefits and mental health or substance
use disorder benefits and that imposes nonquantitative
treatment limitations (referred to in this section as
`NQTL') on mental health or substance use disorder
benefits, the plan or issuer offering health insurance
coverage shall perform comparative analyses of the
design and application of NQTLs in accordance with
subparagraph (B), and, beginning 45 days after the date
of enactment of this paragraph, make available to the
applicable State authority (or, as applicable, the
Secretary), upon request, the comparative analyses and
the following information:
``(i) The specific plan or coverage terms
regarding the NQTL, that applies to such plan
or coverage, and a description of all mental
health or substance use disorder and medical or
surgical benefits to which it applies in each
respective benefits classification.
``(ii) The factors used to determine that
the NQTL will apply to mental health or
substance use disorder benefits and medical or
surgical benefits.
``(iii) The evidentiary standards used for
the factors identified in clause (ii), when
applicable, provided that every factor shall be
defined and any other source or evidence relied
upon to design and apply the NQTL to mental
health or substance use disorder benefits and
medical or surgical benefits.
``(iv) The comparative analyses
demonstrating that the processes, strategies,
evidentiary standards, and other factors used
to design the NQTL, as written, and the
operation processes and strategies as written
and in operation that are used to apply the
NQTL for mental health or substance use
disorder benefits are comparable to, and are
applied no more stringently than, the
processes, strategies, evidentiary standards,
and other factors used to design the NQTL, as
written, and the operation processes and
strategies as written and in operation that are
used to apply the NQTL to medical or surgical
benefits.
``(v) A disclosure of the specific findings
and conclusions reached by the plan or coverage
that the results of the analyses described in
this subparagraph indicate that the plan or
coverage is in compliance with this section.
``(B) Secretary request process.--
``(i) Submission upon request.--The
Secretary shall request that a group health
plan or a health insurance issuer offering
group or individual health insurance coverage
submit the comparative analyses described in
subparagraph (A) for plans that involve
potential violations of this section or
complaints regarding noncompliance with this
section that concern NQTLs and any other
instances in which the Secretary determines
appropriate. The Secretary shall request not
fewer than 20 such analyses per year.
``(ii) Additional information.--In
instances in which the Secretary has concluded
that the plan or coverage has not submitted
sufficient information for the Secretary to
review the comparative analyses described in
subparagraph (A), as requested under clause
(i), the Secretary shall specify to the plan or
coverage the information the plan or coverage
must submit to be responsive to the request
under clause (i) for the Secretary to review
the comparative analyses described in
subparagraph(A) for compliance with this
section. Nothing in this paragraph shall
require the Secretary to conclude that a plan
is in compliance with this section solely based
upon the inspection of the comparative analyses
described in subparagraph (A), as requested
under clause (i).
``(iii) Required action.--
``(I) In general.--In instances in
which the Secretary has reviewed the
comparative analyses described in
subparagraph (A), as requested under
clause (i), and determined that the
plan or coverage is not in compliance
with this section, the plan or
coverage--
``(aa) shall specify to the
Secretary the actions the plan
or coverage will take to be in
compliance with this section
and provide to the Secretary
comparative analyses described
in subparagraph (A) that
demonstrate compliance with
this section not later than 45
days after the initial
determination by the Secretary
that the plan or coverage is
not in compliance; and
``(bb) following the 45-day
corrective action period under
item (aa), if the Secretary
determines that the plan or
coverage still is not in
compliance with this section,
not later than 7 days after
such determination, shall
notify all individuals enrolled
in the plan or coverage that
the plan or coverage has been
determined to be not in
compliance with this section.
``(II) Exemption from disclosure.--
Documents or communications produced in
connection with the Secretary's
recommendations to the plan or coverage
shall not be subject to disclosure
pursuant to section 552 of title 5,
United States Code.
``(iv) Report.--Not later than 1 year after
the date of enactment of this paragraph, and
not later than October 1 of each year
thereafter, the Secretary shall submit to
Congress, and make publicly available, a report
that contains--
``(I) a summary of the comparative
analyses requested under clause (i),
including the identity of each plan or
coverage that is determined to be not
in compliance after the final
determination by the Secretary
described in clause (iii)(I)(bb);
``(II) the Secretary's conclusions
as to whether each plan or coverage
submitted sufficient information for
the Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section;
``(III) for each plan or coverage
that did submit sufficient information
for the Secretary to review the
comparative analyses requested under
clause (i), the Secretary's conclusions
as to whether and why the plan or
coverage is in compliance with the
requirements under this section;
``(IV) the Secretary's
specifications described in clause (ii)
for each plan or coverage that the
Secretary determined did not submit
sufficient information for the
Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section; and
``(V) the Secretary's
specifications described in clause
(iii) of the actions each plan or
coverage that the Secretary determined
is not in compliance with this section
must take to be in compliance with this
section, including the reason why the
Secretary determined the plan or
coverage is not in compliance.
``(C) Compliance program guidance document update
process.--
``(i) In general.--The Secretary shall
include instances of noncompliance that the
Secretary discovers upon reviewing the
comparative analyses requested under
subparagraph (B)(i) in the compliance program
guidance document described in paragraph (6),
as it is updated every 2 years, except that
such instances shall not disclose any protected
health information or individually identifiable
information.
``(ii) Guidance and regulations.--Not later
than 18 months after the date of enactment of
this paragraph, the Secretary shall finalize
any draft or interim guidance and regulations
relating to mental health parity under this
section. Such draft guidance shall include
guidance to clarify the process and timeline
for current and potential participants and
beneficiaries (and authorized representatives
and health care providers of such participants
and beneficiaries) with respect to plans to
file complaints of such plans or issuers being
in violation of this section, including
guidance, by plan type, on the relevant State,
regional, or national office with which such
complaints should be filed.
``(iii) State.--The Secretary shall share
information on findings of compliance and
noncompliance discovered upon reviewing the
comparative analyses requested under
subparagraph (B)(i) with the State where the
group health plan is located or the State where
the health insurance issuer is licensed to do
business for coverage offered by a health
insurance issuer in the group market, in
accordance with paragraph (6)(B)(iii)(II).
``(b) Construction.--Nothing in this section shall be construed--
``(1) as requiring a group health plan or a health
insurance issuer offering group or individual health insurance
coverage to provide any mental health or substance use disorder
benefits; or
``(2) in the case of a group health plan or a health
insurance issuer offering group or individual health insurance
coverage that provides mental health or substance use disorder
benefits, as affecting the terms and conditions of the plan or
coverage relating to such benefits under the plan or coverage,
except as provided in subsection (a).
``(c) Exemptions.--
``(1) Small employer exemption.--This section shall not
apply to any group health plan and a health insurance issuer
offering group or individual health insurance coverage for any
plan year of a small employer (as defined in section
2791(e)(4), except that for purposes of this paragraph such
term shall include employers with 1 employee in the case of an
employer residing in a State that permits small groups to
include a single individual).
``(2) Cost exemption.--
``(A) In general.--With respect to a group health
plan or a health insurance issuer offering group or
individual health insurance coverage, if the
application of this section to such plan (or coverage)
results in an increase for the plan year involved of
the actual total costs of coverage with respect to
medical and surgical benefits and mental health and
substance use disorder benefits under the plan (as
determined and certified under subparagraph (C)) by an
amount that exceeds the applicable percentage described
in subparagraph (B) of the actual total plan costs, the
provisions of this section shall not apply to such plan
(or coverage) during the following plan year, and such
exemption shall apply to the plan (or coverage) for 1
plan year. An employer may elect to continue to apply
mental health and substance use disorder parity
pursuant to this section with respect to the group
health plan (or coverage) involved regardless of any
increase in total costs.
``(B) Applicable percentage.--With respect to a
plan (or coverage), the applicable percentage described
in this subparagraph shall be--
``(i) 2 percent in the case of the first
plan year in which this section is applied; and
``(ii) 1 percent in the case of each
subsequent plan year.
``(C) Determinations by actuaries.--Determinations
as to increases in actual costs under a plan (or
coverage) for purposes of this section shall be made
and certified by a qualified and licensed actuary who
is a member in good standing of the American Academy of
Actuaries. All such determinations shall be in a
written report prepared by the actuary. The report, and
all underlying documentation relied upon by the
actuary, shall be maintained by the group health plan
or health insurance issuer for a period of 6 years
following the notification made under subparagraph (E).
``(D) 6-month determinations.--If a group health
plan (or a health insurance issuer offering coverage in
connection with a group health plan) seeks an exemption
under this paragraph, determinations under subparagraph
(A) shall be made after such plan (or coverage) has
complied with this section for the first 6 months of
the plan year involved.
``(E) Notification.--
``(i) In general.--A group health plan (or
a health insurance issuer offering coverage in
connection with a group health plan) that,
based upon a certification described under
subparagraph (C), qualifies for an exemption
under this paragraph, and elects to implement
the exemption, shall promptly notify the
Secretary, the appropriate State agencies, and
participants and beneficiaries in the plan of
such election.
``(ii) Requirement.--A notification to the
Secretary under clause (i) shall include--
``(I) a description of the number
of covered lives under the plan (or
coverage) involved at the time of the
notification, and as applicable, at the
time of any prior election of the cost-
exemption under this paragraph by such
plan (or coverage);
``(II) for both the plan year upon
which a cost exemption is sought and
the year prior, a description of the
actual total costs of coverage with
respect to medical and surgical
benefits and mental health and
substance use disorder benefits under
the plan; and
``(III) for both the plan year upon
which a cost exemption is sought and
the year prior, the actual total costs
of coverage with respect to mental
health and substance use disorder
benefits under the plan.
``(iii) Confidentiality.--A notification to
the Secretary under clause (i) shall be
confidential. The Secretary shall make
available, upon request and on not more than an
annual basis, an anonymous itemization of such
notifications, that includes--
``(I) a breakdown of States by the
size and type of employers submitting
such notification; and
``(II) a summary of the data
received under clause (ii).
``(F) Audits by appropriate agencies.--To determine
compliance with this paragraph, the Secretary may audit
the books and records of a group health plan or health
insurance issuer relating to an exemption, including
any actuarial reports prepared pursuant to subparagraph
(C), during the 6 year period following the
notification of such exemption under subparagraph (E).
A State agency receiving a notification under
subparagraph (E) may also conduct such an audit with
respect to an exemption covered by such notification.
``(d) Separate Application to Each Option Offered.--In the case of
a group health plan that offers a participant or beneficiary two or
more benefit package options under the plan, the requirements of this
section shall be applied separately with respect to each such option.
``(e) Definitions.--For purposes of this section--
``(1) Aggregate lifetime limit.--The term `aggregate
lifetime limit' means, with respect to benefits under a group
health plan or health insurance coverage, a dollar limitation
on the total amount that may be paid with respect to such
benefits under the plan or health insurance coverage with
respect to an individual or other coverage unit.
``(2) Annual limit.--The term `annual limit' means, with
respect to benefits under a group health plan or health
insurance coverage, a dollar limitation on the total amount of
benefits that may be paid with respect to such benefits in a
12-month period under the plan or health insurance coverage
with respect to an individual or other coverage unit.
``(3) Medical or surgical benefits.--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 (as the case may be), but does not include mental
health or substance use disorder benefits.
``(4) Mental health benefits.--The term `mental health
benefits' means benefits with respect to services for mental
health conditions, as defined under the terms of the plan and
in accordance with applicable Federal and State law.
``(5) Substance use disorder benefits.--The term `substance
use disorder benefits' means benefits with respect to services
for substance use disorders, as defined under the terms of the
plan and in accordance with applicable Federal and State
law.''.
(2) Sunset.--Section 2726 of the Public Health Service Act
(42 U.S.C. 300gg-26) is amended by adding at the end the
following new subsection
``(f) Sunset.--The provisions of this section shall have no force
or effect after the date of the enactment of the Strengthening
Behavioral Health Parity Act.''.
(3) Administration; conforming amendments.--
(A) Application of implementation regulations.--The
provisions of sections 146.136 and 147.160 of title 45,
Code of Federal Regulations shall apply to section
2799A-1 of the Public Health Service Act, as added by
paragraph (1), in the same manner as such provisions
applied to section 2726 of the Public Health Service
Act (42 U.S.C. 300gg-26) before the date of the
enactment of this Act.
(B) Conforming amendments.--
(i) Section 2722 of the Public Health
Service Act (42 U.S.C. 300gg-21) is amended--
(I) in subsection (a)(1), by
inserting ``and part D'' after
``subparts 1 and 2'';
(II) in subsection (b), by
inserting ``and part D'' after
``subparts 1 and 2'';
(III) in subsection (c)(1), by
inserting ``and part D'' after
``subparts 1 and 2'';
(IV) in subsection (c)(2), by
inserting ``and part D'' after
``subparts 1 and 2'';
(V) in subsection (c)(3), by
inserting ``and part D'' after ``this
part''; and
(VI) in subsection (d), in the
matter preceding paragraph (1), by
inserting ``and part D'' after ``this
part''.
(ii) Section 2723 of the Public Health
Service Act (42 U.S.C. 300gg-22) is amended--
(I) in subsection (a)(1), by
inserting ``and part D'' after ``this
part'';
(II) in subsection (a)(2), by
inserting ``or part D'' after ``this
part'';
(III) in subsection (b)(1), by
inserting ``or part D'' after ``this
part'';
(IV) in subsection (b)(2)(A), by
inserting ``or part D'' after ``this
part''; and
(V) in subsection (b)(2)(C)(ii), by
inserting ``and part D'' after ``this
part''.
(iii) Section 2724 of the Public Health
Service Act (42 U.S.C. 300gg-23) is amended--
(I) in subsection (a)(1)--
(aa) by striking ``this
part and part C insofar as it
relates to this part'' and
inserting ``this part, part D,
and part C insofar as it
relates to this part or part
D''; and
(bb) by inserting ``or part
D'' after ``requirement of this
part'';
(II) in subsection (a)(2), by
inserting ``or part D'' after ``this
part''; and
(III) in subsection (c), by
inserting ``or part D'' after ``this
part (other than section 2704)''.
(b) ERISA.--Section 712(a) of the Employee Retirement Income
Security Act of 1974 (1185a(a)) is amended by adding at the end the
following new paragraphs:
``(6) Compliance program guidance document.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Health and Human Services, and the
Secretary of the Treasury, in consultation with the
Inspector General of the Department of Health and Human
Services, the Inspector General of the Department of
Labor, and the Inspector General of the Department of
the Treasury, shall issue a compliance program guidance
document to help improve compliance with this section,
section 2799A-1 of the Public Health Service Act, and
section 9812 of the Internal Revenue Code of 1986, as
applicable. In carrying out this paragraph, the
Secretaries may take into consideration the 2016
publication of the Department of Health and Human
Services and the Department of Labor, entitled `Warning
Signs - Plan or Policy Non-Quantitative Treatment
Limitations (NQTLs) that Require Additional Analysis to
Determine Mental Health Parity Compliance'.
``(B) Examples illustrating compliance and
noncompliance.--
``(i) In general.--The compliance program
guidance document required under this paragraph
shall provide illustrative, de-identified
examples (that do not disclose any protected
health information or individually identifiable
information) of previous findings of compliance
and noncompliance with this section, section
2799A-1 of the Public Health Service Act, or
section 9812 of the Internal Revenue Code of
1986, as applicable, based on investigations of
violations of such sections, including--
``(I) examples illustrating
requirements for information
disclosures and nonquantitative
treatment limitations; and
``(II) descriptions of the
violations uncovered during the course
of such investigations.
``(ii) Nonquantitative treatment
limitations.--To the extent that any example
described in clause (i) involves a finding of
compliance or noncompliance with regard to any
requirement for nonquantitative treatment
limitations, the example shall provide
sufficient detail to fully explain such
finding, including a full description of the
criteria involved for approving medical and
surgical benefits and the criteria involved for
approving mental health and substance use
disorder benefits.
``(iii) Access to additional information
regarding compliance.--In developing and
issuing the compliance program guidance
document required under this paragraph, the
Secretaries specified in subparagraph (A)--
``(I) shall enter into interagency
agreements with the Inspector General
of the Department of Health and Human
Services, the Inspector General of the
Department of Labor, and the Inspector
General of the Department of the
Treasury to share findings of
compliance and noncompliance with this
section, section 2799A-1 of the Public
Health Service Act, or section 9812 of
the Internal Revenue Code of 1986, as
applicable; and
``(II) shall seek to enter into an
agreement with a State to share
information on findings of compliance
and noncompliance with this section,
section 2799A-1 of the Public Health
Service Act, or section 9812 of the
Internal Revenue Code of 1986, as
applicable.
``(C) Recommendations.--The compliance program
guidance document shall include recommendations to
advance compliance with this section, section 2799A-1
of the Public Health Service Act, or section 9812 of
the Internal Revenue Code of 1986, as applicable, and
encourage the development and use of internal controls
to monitor adherence to applicable statutes,
regulations, and program requirements. Such internal
controls may include illustrative examples of
nonquantitative treatment limitations on mental health
and substance use disorder benefits, which may fail to
comply with this section, section 2799A-1 of the Public
Health Service Act, or section 9812 of the Internal
Revenue Code of 1986, as applicable, in relation to
nonquantitative treatment limitations on medical and
surgical benefits.
``(D) Updating the compliance program guidance
document.--The Secretary, the Secretary of Health and
Human Services, and the Secretary of the Treasury, in
consultation with the Inspector General of the
Department of Health and Human Services, the Inspector
General of the Department of Labor, and the Inspector
General of the Department of the Treasury, shall update
the compliance program guidance document every 2 years
to include illustrative, de-identified examples (that
do not disclose any protected health information or
individually identifiable information) of previous
findings of compliance and noncompliance with this
section, section 2799A-1 of the Public Health Service
Act, or section 9812 of the Internal Revenue Code of
1986, as applicable.
``(7) Additional guidance.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Health and Human Services, and the
Secretary of the Treasury shall issue guidance to group
health plans and health insurance issuers offering
group or individual health insurance coverage to assist
such plans and issuers in satisfying the requirements
of this section, section 2799A-1 of the Public Health
Service Act, or section 9812 of the Internal Revenue
Code of 1986, as applicable.
``(B) Disclosure.--
``(i) Guidance for plans and issuers.--The
guidance issued under this paragraph shall
include clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or
individual health insurance coverage may use
for disclosing information to ensure compliance
with the requirements under this section,
section 2799A-1 of the Public Health Service
Act, or section 9812 of the Internal Revenue
Code of 1986, as applicable, (and any
regulations promulgated pursuant to such
sections, as applicable).
``(ii) Documents for participants,
beneficiaries, contracting providers, or
authorized representatives.--The guidance
issued under this paragraph shall include
clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or
individual health insurance coverage may use to
provide any participant, beneficiary,
contracting provider, or authorized
representative, as applicable, with documents
containing information that the health plans or
issuers are required to disclose to
participants, beneficiaries, contracting
providers, or authorized representatives to
ensure compliance with this section, section
2799A-1 of the Public Health Service Act, or
section 9812 of the Internal Revenue Code of
1986, as applicable, compliance with any
regulation issued pursuant to such respective
section, or compliance with any other
applicable law or regulation. Such guidance
shall include information that is comparative
in nature with respect to--
``(I) nonquantitative treatment
limitations for both medical and
surgical benefits and mental health and
substance use disorder benefits;
``(II) the processes, strategies,
evidentiary standards, and other
factors used to apply the limitations
described in subclause (I); and
``(III) the application of the
limitations described in subclause (I)
to ensure that such limitations are
applied in parity with respect to both
medical and surgical benefits and
mental health and substance use
disorder benefits.
``(C) Nonquantitative treatment limitations.--The
guidance issued under this paragraph shall include
clarifying information and illustrative examples of
methods, processes, strategies, evidentiary standards,
and other factors that group health plans and health
insurance issuers offering group or individual health
insurance coverage may use regarding the development
and application of nonquantitative treatment
limitations to ensure compliance with this section,
section 2799A-1 of the Public Health Service Act, or
section 9812 of the Internal Revenue Code of 1986, as
applicable, (and any regulations promulgated pursuant
to such respective section), including--
``(i) examples of methods of determining
appropriate types of nonquantitative treatment
limitations with respect to both medical and
surgical benefits and mental health and
substance use disorder benefits, including
nonquantitative treatment limitations
pertaining to--
``(I) medical management standards
based on medical necessity or
appropriateness, or whether a treatment
is experimental or investigative;
``(II) limitations with respect to
prescription drug formulary design; and
``(III) use of fail-first or step
therapy protocols;
``(ii) examples of methods of determining--
``(I) network admission standards
(such as credentialing); and
``(II) factors used in provider
reimbursement methodologies (such as
service type, geographic market, demand
for services, and provider supply,
practice size, training, experience,
and licensure) as such factors apply to
network adequacy;
``(iii) examples of sources of information
that may serve as evidentiary standards for the
purposes of making determinations regarding the
development and application of nonquantitative
treatment limitations;
``(iv) examples of specific factors, and
the evidentiary standards used to evaluate such
factors, used by such plans or issuers in
performing a nonquantitative treatment
limitation analysis;
``(v) examples of how specific evidentiary
standards may be used to determine whether
treatments are considered experimental or
investigative;
``(vi) examples of how specific evidentiary
standards may be applied to each service
category or classification of benefits;
``(vii) examples of methods of reaching
appropriate coverage determinations for new
mental health or substance use disorder
treatments, such as evidence-based early
intervention programs for individuals with a
serious mental illness and types of medical
management techniques;
``(viii) examples of methods of reaching
appropriate coverage determinations for which
there is an indirect relationship between the
covered mental health or substance use disorder
benefit and a traditional covered medical and
surgical benefit, such as residential treatment
or hospitalizations involving voluntary or
involuntary commitment; and
``(ix) additional illustrative examples of
methods, processes, strategies, evidentiary
standards, and other factors for which the
Secretary determines that additional guidance
is necessary to improve compliance with this
section, section 2799A-1 of the Public Health
Service Act, or section 9812 of the Internal
Revenue Code of 1986, as applicable.
``(D) Public comment.--Prior to issuing any final
guidance under this paragraph, the Secretary shall
provide a public comment period of not less than 60
days during which any member of the public may provide
comments on a draft of the guidance.
``(8) Compliance requirements.--
``(A) Nonquantitative treatment limitation (nqtl)
requirements.--Beginning 45 days after the date of
enactment of this paragraph, in the case of a group
health plan or a health insurance issuer offering group
health insurance coverage that provides both medical
and surgical benefits and mental health or substance
use disorder benefits and that imposes nonquantitative
treatment limitations (referred to in this section as
`NQTL') on mental health or substance use disorder
benefits, the plan or issuer offering health insurance
coverage shall perform comparative analyses of the
design and application of NQTLs in accordance with
subparagraph (B), and make available to the applicable
State authority (or, as applicable, the Secretary),
upon request, the following information:
``(i) The specific plan or coverage terms
regarding the NQTL, that applies to such plan
or coverage, and a description of all mental
health or substance use disorder and medical or
surgical benefits to which it applies in each
respective benefits classification.
``(ii) The factors used to determine that
the NQTL will apply to mental health or
substance use disorder benefits and medical or
surgical benefits.
``(iii) The evidentiary standards used for
the factors identified in clause (ii), when
applicable, provided that every factor shall be
defined and any other source or evidence relied
upon to design and apply the NQTL to mental
health or substance use disorder benefits and
medical or surgical benefits.
``(iv) The comparative analyses
demonstrating that the processes, strategies,
evidentiary standards, and other factors used
to design the NQTL, as written, and the
operation processes and strategies as written
and in operation that are used to apply the
NQTL for mental health or substance use
disorder benefits are comparable to, and are
applied no more stringently than, the
processes, strategies, evidentiary standards,
and other factors used to design the NQTL, as
written, and the operation processes and
strategies as written and in operation that are
used to apply the NQTL to medical or surgical
benefits.
``(v) A disclosure of the specific findings
and conclusions reached by the plan or coverage
that the results of the analyses described in
this subparagraph indicate that the plan or
coverage is in compliance with this section.
``(B) Secretary request process.--
``(i) Submission upon request.--The
Secretary shall request that a group health
plan or a health insurance issuer offering
group health insurance coverage submit the
comparative analyses described in subparagraph
(A) for plans that involve potential violations
of this section or complaints regarding
noncompliance with this section that concern
NQTLs and any other instances in which the
Secretary determines appropriate. The Secretary
shall request not fewer than 20 such analyses
per year.
``(ii) Additional information.--In
instances in which the Secretary has concluded
that the plan or coverage has not submitted
sufficient information for the Secretary to
review the comparative analyses described in
subparagraph (A), as requested under clause
(i), the Secretary shall specify to the plan or
coverage the information the plan or coverage
must submit to be responsive to the request
under clause (i) for the Secretary to review
the comparative analyses described in
subparagraph(A) for compliance with this
section. Nothing in this paragraph shall
require the Secretary to conclude that a plan
is in compliance with this section solely based
upon the inspection of the comparative analyses
described in subparagraph (A), as requested
under clause (i).
``(iii) Required action.--
``(I) In general.--In instances in
which the Secretary has reviewed the
comparative analyses described in
subparagraph (A), as requested under
clause (i), and determined that the
plan or coverage is not in compliance
with this section, the plan or
coverage--
``(aa) shall specify to the
Secretary the actions the plan
or coverage will take to be in
compliance with this section
and provide to the Secretary
comparative analyses described
in subparagraph (A) that
demonstrate compliance with
this section not later than 45
days after the initial
determination by the Secretary
that the plan or coverage is
not in compliance; and
``(bb) following the 45-day
corrective action period under
item (aa), if the Secretary
determines that the plan or
coverage still is not in
compliance with this section,
not later than 7 days after
such determination, shall
notify all individuals enrolled
in the plan or coverage that
the plan or coverage has been
determined to be not in
compliance with this section.
``(II) Exemption from disclosure.--
Documents or communications produced in
connection with the Secretary's
recommendations to the plan or coverage
shall not be subject to disclosure
pursuant to section 552 of title 5,
United States Code.
``(iv) Report.--Not later than 1 year after
the date of enactment of this paragraph, and
not later than October 1 of each year
thereafter, the Secretary shall submit to
Congress, and make publicly available, a report
that contains--
``(I) a summary of the comparative
analyses requested under clause (i),
including the identity of each plan or
coverage that is determined to be not
in compliance after the final
determination by the Secretary
described in clause (iii)(I)(bb);
``(II) the Secretary's conclusions
as to whether each plan or coverage
submitted sufficient information for
the Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section;
``(III) for each plan or coverage
that did submit sufficient information
for the Secretary to review the
comparative analyses requested under
clause (i), the Secretary's conclusions
as to whether and why the plan or
coverage is in compliance with the
requirements under this section;
``(IV) the Secretary's
specifications described in clause (ii)
for each plan or coverage that the
Secretary determined did not submit
sufficient information for the
Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section; and
``(V) the Secretary's
specifications described in clause
(iii) of the actions each plan or
coverage that the Secretary determined
is not in compliance with this section
must take to be in compliance with this
section, including the reason why the
Secretary determined the plan or
coverage is not in compliance.
``(C) Compliance program guidance document update
process.--
``(i) In general.--The Secretary shall
include instances of noncompliance that the
Secretary discovers upon reviewing the
comparative analyses requested under
subparagraph (B)(i) in the compliance program
guidance document described in paragraph (6),
as it is updated every 2 years, except that
such instances shall not disclose any protected
health information or individually identifiable
information.
``(ii) Guidance and regulations.--Not later
than 18 months after the date of enactment of
this paragraph, the Secretary shall finalize
any draft or interim guidance and regulations
relating to mental health parity under this
section. Such draft guidance shall include
guidance to clarify the process and timeline
for current and potential participants and
beneficiaries (and authorized representatives
and health care providers of such participants
and beneficiaries) with respect to plans to
file complaints of such plans or issuers being
in violation of this section, including
guidance, by plan type, on the relevant State,
regional, or national office with which such
complaints should be filed.
``(iii) State.--The Secretary shall share
information on findings of compliance and
noncompliance discovered upon reviewing the
comparative analyses requested under
subparagraph (B)(i) with the State where the
group health plan is located or the State where
the health insurance issuer is licensed to do
business for coverage offered by a health
insurance issuer in the group market, in
accordance with paragraph (6)(B)(iii)(II).''.
(c) IRC.--Section 9812 of the Internal Revenue Code of 1986 is
amended by adding at the end the following new paragraphs:
``(6) Compliance program guidance document.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Labor, and the Secretary of Health and
Human Services, in consultation with the Inspector
General of the Department of Health and Human Services,
the Inspector General of the Department of Labor, and
the Inspector General of the Department of the
Treasury, shall issue a compliance program guidance
document to help improve compliance with this section,
section 712 of the Employee Retirement Income Security
Act of 1974, and section 2799A-1 of the Public Health
Service Act, as applicable. In carrying out this
paragraph, the Secretaries may take into consideration
the 2016 publication of the Department of Health and
Human Services and the Department of Labor, entitled
`Warning Signs - Plan or Policy Non-Quantitative
Treatment Limitations (NQTLs) that Require Additional
Analysis to Determine Mental Health Parity Compliance'.
``(B) Examples illustrating compliance and
noncompliance.--
``(i) In general.--The compliance program
guidance document required under this paragraph
shall provide illustrative, de-identified
examples (that do not disclose any protected
health information or individually identifiable
information) of previous findings of compliance
and noncompliance with this section, section
712 of the Employee Retirement Income Security
Act of 1974, or section 2799A-1 of the Public
Health Service Act, as applicable, based on
investigations of violations of such sections,
including--
``(I) examples illustrating
requirements for information
disclosures and nonquantitative
treatment limitations; and
``(II) descriptions of the
violations uncovered during the course
of such investigations.
``(ii) Nonquantitative treatment
limitations.--To the extent that any example
described in clause (i) involves a finding of
compliance or noncompliance with regard to any
requirement for nonquantitative treatment
limitations, the example shall provide
sufficient detail to fully explain such
finding, including a full description of the
criteria involved for approving medical and
surgical benefits and the criteria involved for
approving mental health and substance use
disorder benefits.
``(iii) Access to additional information
regarding compliance.--In developing and
issuing the compliance program guidance
document required under this paragraph, the
Secretaries specified in subparagraph (A)--
``(I) shall enter into interagency
agreements with the Inspector General
of the Department of Health and Human
Services, the Inspector General of the
Department of Labor, and the Inspector
General of the Department of the
Treasury to share findings of
compliance and noncompliance with this
section, section 712 of the Employee
Retirement Income Security Act of 1974,
or section 2799A-1 of the Public Health
Service Act, as applicable; and
``(II) shall seek to enter into an
agreement with a State to share
information on findings of compliance
and noncompliance with this section,
section 712 of the Employee Retirement
Income Security Act of 1974, or section
2799A-1 of the Public Health Service
Act, as applicable.
``(C) Recommendations.--The compliance program
guidance document shall include recommendations to
advance compliance with this section, section 712 of
the Employee Retirement Income Security Act of 1974, or
section 2799A-1 of the Public Health Service Act, as
applicable, and encourage the development and use of
internal controls to monitor adherence to applicable
statutes, regulations, and program requirements. Such
internal controls may include illustrative examples of
nonquantitative treatment limitations on mental health
and substance use disorder benefits, which may fail to
comply with this section, section 712 of the Employee
Retirement Income Security Act of 1974, or section
2799A-1 of the Public Health Service Act, as
applicable, in relation to nonquantitative treatment
limitations on medical and surgical benefits.
``(D) Updating the compliance program guidance
document.--The Secretary, the Secretary of Labor, and
the Secretary of Health and Human Services, in
consultation with the Inspector General of the
Department of Health and Human Services, the Inspector
General of the Department of Labor, and the Inspector
General of the Department of the Treasury, shall update
the compliance program guidance document every 2 years
to include illustrative, de-identified examples (that
do not disclose any protected health information or
individually identifiable information) of previous
findings of compliance and noncompliance with this
section, section 712 of the Employee Retirement Income
Security Act of 1974, or section 2799A-1 of the Public
Health Service Act, as applicable.
``(7) Additional guidance.--
``(A) In general.--Not later than 12 months after
the date of enactment of the Helping Families in Mental
Health Crisis Reform Act of 2016, the Secretary, the
Secretary of Labor, and the Secretary of Health and
Human Services shall issue guidance to group health
plans and health insurance issuers offering group or
individual health insurance coverage to assist such
plans and issuers in satisfying the requirements of
this section, section 712 of the Employee Retirement
Income Security Act of 1974, or section 2799A-1 of the
Public Health Service Act, as applicable.
``(B) Disclosure.--
``(i) Guidance for plans and issuers.--The
guidance issued under this paragraph shall
include clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or
individual health insurance coverage may use
for disclosing information to ensure compliance
with the requirements under this section,
section 712 of the Employee Retirement Income
Security Act of 1974, or section 2799A-1 of the
Public Health Service Act, (and any regulations
promulgated pursuant to such sections, as
applicable).
``(ii) Documents for participants,
beneficiaries, contracting providers, or
authorized representatives.--The guidance
issued under this paragraph shall include
clarifying information and illustrative
examples of methods that group health plans and
health insurance issuers offering group or
individual health insurance coverage may use to
provide any participant, beneficiary,
contracting provider, or authorized
representative, as applicable, with documents
containing information that the health plans or
issuers are required to disclose to
participants, beneficiaries, contracting
providers, or authorized representatives to
ensure compliance with this section, section
712 of the Employee Retirement Income Security
Act of 1974, or section 2799A-1 of the Public
Health Service Act, as applicable, compliance
with any regulation issued pursuant to such
respective section, or compliance with any
other applicable law or regulation. Such
guidance shall include information that is
comparative in nature with respect to--
``(I) nonquantitative treatment
limitations for both medical and
surgical benefits and mental health and
substance use disorder benefits;
``(II) the processes, strategies,
evidentiary standards, and other
factors used to apply the limitations
described in subclause (I); and
``(III) the application of the
limitations described in subclause (I)
to ensure that such limitations are
applied in parity with respect to both
medical and surgical benefits and
mental health and substance use
disorder benefits.
``(C) Nonquantitative treatment limitations.--The
guidance issued under this paragraph shall include
clarifying information and illustrative examples of
methods, processes, strategies, evidentiary standards,
and other factors that group health plans and health
insurance issuers offering group or individual health
insurance coverage may use regarding the development
and application of nonquantitative treatment
limitations to ensure compliance with this section,
section 712 of the Employee Retirement Income Security
Act of 1974, or section 2799A-1 of the Public Health
Service Act, as applicable, (and any regulations
promulgated pursuant to such respective section),
including--
``(i) examples of methods of determining
appropriate types of nonquantitative treatment
limitations with respect to both medical and
surgical benefits and mental health and
substance use disorder benefits, including
nonquantitative treatment limitations
pertaining to--
``(I) medical management standards
based on medical necessity or
appropriateness, or whether a treatment
is experimental or investigative;
``(II) limitations with respect to
prescription drug formulary design; and
``(III) use of fail-first or step
therapy protocols;
``(ii) examples of methods of determining--
``(I) network admission standards
(such as credentialing); and
``(II) factors used in provider
reimbursement methodologies (such as
service type, geographic market, demand
for services, and provider supply,
practice size, training, experience,
and licensure) as such factors apply to
network adequacy;
``(iii) examples of sources of information
that may serve as evidentiary standards for the
purposes of making determinations regarding the
development and application of nonquantitative
treatment limitations;
``(iv) examples of specific factors, and
the evidentiary standards used to evaluate such
factors, used by such plans or issuers in
performing a nonquantitative treatment
limitation analysis;
``(v) examples of how specific evidentiary
standards may be used to determine whether
treatments are considered experimental or
investigative;
``(vi) examples of how specific evidentiary
standards may be applied to each service
category or classification of benefits;
``(vii) examples of methods of reaching
appropriate coverage determinations for new
mental health or substance use disorder
treatments, such as evidence-based early
intervention programs for individuals with a
serious mental illness and types of medical
management techniques;
``(viii) examples of methods of reaching
appropriate coverage determinations for which
there is an indirect relationship between the
covered mental health or substance use disorder
benefit and a traditional covered medical and
surgical benefit, such as residential treatment
or hospitalizations involving voluntary or
involuntary commitment; and
``(ix) additional illustrative examples of
methods, processes, strategies, evidentiary
standards, and other factors for which the
Secretary determines that additional guidance
is necessary to improve compliance with this
section, section 712 of the Employee Retirement
Income Security Act of 1974, or section 2799A-1
of the Public Health Service Act, as
applicable.
``(D) Public comment.--Prior to issuing any final
guidance under this paragraph, the Secretary shall
provide a public comment period of not less than 60
days during which any member of the public may provide
comments on a draft of the guidance.
``(8) Compliance requirements.--
``(A) Nonquantitative treatment limitation (nqtl)
requirements.--Beginning 45 days after the date of
enactment of this paragraph, in the case of a group
health plan that provides both medical and surgical
benefits and mental health or substance use disorder
benefits and that imposes nonquantitative treatment
limitations (referred to in this section as `NQTL') on
mental health or substance use disorder benefits, the
plan shall perform comparative analyses of the design
and application of NQTLs in accordance with
subparagraph (B), and make available to the applicable
State authority (or, as applicable, the Secretary),
upon request, the following information:
``(i) The specific plan terms regarding the
NQTL, that applies to such plan or coverage,
and a description of all mental health or
substance use disorder and medical or surgical
benefits to which it applies in each respective
benefits classification.
``(ii) The factors used to determine that
the NQTL will apply to mental health or
substance use disorder benefits and medical or
surgical benefits.
``(iii) The evidentiary standards used for
the factors identified in clause (ii), when
applicable, provided that every factor shall be
defined and any other source or evidence relied
upon to design and apply the NQTL to mental
health or substance use disorder benefits and
medical or surgical benefits.
``(iv) The comparative analyses
demonstrating that the processes, strategies,
evidentiary standards, and other factors used
to design the NQTL, as written, and the
operation processes and strategies as written
and in operation that are used to apply the
NQTL for mental health or substance use
disorder benefits are comparable to, and are
applied no more stringently than, the
processes, strategies, evidentiary standards,
and other factors used to design the NQTL, as
written, and the operation processes and
strategies as written and in operation that are
used to apply the NQTL to medical or surgical
benefits.
``(v) A disclosure of the specific findings
and conclusions reached by the plan that the
results of the analyses described in this
subparagraph indicate that the plan is in
compliance with this section.
``(B) Secretary request process.--
``(i) Submission upon request.--The
Secretary shall request that a group health
plan submit the comparative analyses described
in subparagraph (A) for plans that involve
potential violations of this section or
complaints regarding noncompliance with this
section that concern NQTLs and any other
instances in which the Secretary determines
appropriate. The Secretary shall request not
fewer than 20 such analyses per year.
``(ii) Additional information.--In
instances in which the Secretary has concluded
that the plan has not submitted sufficient
information for the Secretary to review the
comparative analyses described in subparagraph
(A), as requested under clause (i), the
Secretary shall specify to the plan the
information the plan or coverage must submit to
be responsive to the request under clause (i)
for the Secretary to review the comparative
analyses described in subparagraph(A) for
compliance with this section. Nothing in this
paragraph shall require the Secretary to
conclude that a plan is in compliance with this
section solely based upon the inspection of the
comparative analyses described in subparagraph
(A), as requested under clause (i).
``(iii) Required action.--
``(I) In general.--In instances in
which the Secretary has reviewed the
comparative analyses described in
subparagraph (A), as requested under
clause (i), and determined that the
plan is not in compliance with this
section, the plan--
``(aa) shall specify to the
Secretary the actions the plan
will take to be in compliance
with this section and provide
to the Secretary comparative
analyses described in
subparagraph (A) that
demonstrate compliance with
this section not later than 45
days after the initial
determination by the Secretary
that the plan is not in
compliance; and
``(bb) following the 45-day
corrective action period under
item (aa), if the Secretary
determines that the plan still
is not in compliance with this
section, not later than 7 days
after such determination, shall
notify all individuals enrolled
in the plan or coverage that
the plan has been determined to
be not in compliance with this
section.
``(II) Exemption from disclosure.--
Documents or communications produced in
connection with the Secretary's
recommendations to the plan or coverage
shall not be subject to disclosure
pursuant to section 552 of title 5,
United States Code.
``(iv) Report.--Not later than 1 year after
the date of enactment of this paragraph, and
not later than October 1 of each year
thereafter, the Secretary shall submit to
Congress, and make publicly available, a report
that contains--
``(I) a summary of the comparative
analyses requested under clause (i),
including the identity of each plan
that is determined to be not in
compliance after the final
determination by the Secretary
described in clause (iii)(I)(bb);
``(II) the Secretary's conclusions
as to whether each plan submitted
sufficient information for the
Secretary to review the comparative
analyses requested under clause (i) for
compliance with this section;
``(III) for each plan that did
submit sufficient information for the
Secretary to review the comparative
analyses requested under clause (i),
the Secretary's conclusions as to
whether and why the plan or coverage is
in compliance with the requirements
under this section;
``(IV) the Secretary's
specifications described in clause (ii)
for each plan that the Secretary
determined did not submit sufficient
information for the Secretary to review
the comparative analyses requested
under clause (i) for compliance with
this section; and
``(V) the Secretary's
specifications described in clause
(iii) of the actions each plan hat the
Secretary determined is not in
compliance with this section must take
to be in compliance with this section,
including the reason why the Secretary
determined the plan or coverage is not
in compliance.
``(C) Compliance program guidance document update
process.--
``(i) In general.--The Secretary shall
include instances of noncompliance that the
Secretary discovers upon reviewing the
comparative analyses requested under
subparagraph (B)(i) in the compliance program
guidance document described in paragraph (6),
as it is updated every 2 years, except that
such instances shall not disclose any protected
health information or individually identifiable
information.
``(ii) Guidance and regulations.--Not later
than 18 months after the date of enactment of
this paragraph, the Secretary shall finalize
any draft or interim guidance and regulations
relating to mental health parity under this
section. Such draft guidance shall include
guidance to clarify the process and timeline
for current and potential participants and
beneficiaries (and authorized representatives
and health care providers of such participants
and beneficiaries) with respect to plans to
file complaints of such plans or issuers being
in violation of this section, including
guidance, by plan type, on the relevant State,
regional, or national office with which such
complaints should be filed.
``(iii) State.--The Secretary shall share
information on findings of compliance and
noncompliance discovered upon reviewing the
comparative analyses requested under
subparagraph (B)(i) with the State where the
group health plan is located or the State where
the health insurance issuer is licensed to do
business for coverage offered by a health
insurance issuer in the group market, in
accordance with paragraph (6)(B)(iii)(II).''.
(d) Implementation.--The Secretary of Health and Human Services,
the Secretary of Labor, and the Secretary of the Treasury may implement
the paragraph (8) of section 2799A-1(a) of the Public Health Service
Act, added by subsection (a), the paragraph (8) of section 712(a) of
the Employee Retirement Income Security Act of 1974, as addedby
subsection (b), and the paragraph (8) of section 9812(a) of the
Internal Revenue Code of 1986, as added by subsection (c), by program
instruction, guidance, or otherwise.
Union Calendar No. 575
116th CONGRESS
2d Session
H. R. 7539
[Report No. 116-692, Part I]
_______________________________________________________________________
A BILL
To strengthen parity in mental health and substance use disorder
benefits.
_______________________________________________________________________
December 24, 2020
Reported from the Committee on Energy and Commerce with an amendment
December 24, 2020
Committees on Ways and Means and Education and Labor discharged;
committed to the Committee of the Whole House on the State of the Union
and ordered to be printed