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 deter-
mining appropriate types of nonquantita-
tive treatment limitations with respect to 
both medical and surgical benefits and men-
tal health and substance use disorder bene-
fits, including nonquantitative treatment 
limitations pertaining to— 
‘‘(I) medical management stand-
ards based on medical necessity or ap-
propriateness, 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 ther-
apy protocols; 
‘‘(ii) examples of methods of deter-
mining— 
‘‘(I) network admission standards 
(such as credentialing); and 
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‘‘(II) factors used in provider re-
imbursement methodologies (such as 
service type, geographic market, de-
mand for services, and provider sup-
ply, practice size, training, experience, 
and licensure) as such factors apply to 
network adequacy; 
‘‘(iii) examples of sources of informa-
tion that may serve as evidentiary stand-
ards for the purposes of making determina-
tions regarding the development and appli-
cation of nonquantitative treatment limita-
tions; 
‘‘(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 evi-
dentiary standards may be used to deter-
mine whether treatments are considered ex-
perimental or investigative; 
‘‘(vi) examples of how specific evi-
dentiary standards may be applied to each 
service category or classification of benefits; 
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‘‘(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 med-
ical management techniques; 
‘‘(viii) examples of methods of reaching 
appropriate coverage determinations for 
which there is an indirect relationship be-
tween the covered mental health or sub-
stance use disorder benefit and a traditional 
covered medical and surgical benefit, such 
as residential treatment or hospitalizations 
involving voluntary or involuntary commit-
ment; and 
‘‘(ix) additional illustrative examples 
of methods, processes, strategies, evidentiary 
standards, and other factors for which the 
Secretary determines that additional guid-
ance is necessary to improve compliance 
with this section, section 712 of the Em-
ployee Retirement Income Security Act of 
1974, or section 2799A–1 of the Public 
Health Service Act, as applicable. 
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‘‘(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 mem-
ber of the public may provide comments on a 
draft of the guidance. 
‘‘(8) COMPLIANCE REQUIREMENTS.— 
‘‘(A) NONQUANTITATIVE TREATMENT LIMI-
TATION (NQTL) REQUIREMENTS.—Beginning 45 
days after the date of enactment of this para-
graph, 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 lim-
itations (referred to in this section as ‘NQTL’) 
on mental health or substance use disorder bene-
fits, the plan shall perform comparative analyses 
of the design and application of NQTLs in ac-
cordance 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 cov-
erage, and a description of all mental health 
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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 dem-
onstrating that the processes, strategies, evi-
dentiary standards, and other factors used 
to design the NQTL, as written, and the op-
eration 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 proc-
esses, strategies, evidentiary standards, and 
other factors used to design the NQTL, as 
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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 find-
ings 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 anal-
yses described in subparagraph (A) for 
plans that involve potential violations of 
this section or complaints regarding non-
compliance 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 con-
cluded that the plan has not submitted suf-
ficient information for the Secretary to re-
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section and provide to the Sec-
retary comparative analyses de-
scribed 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 deter-
mines that the plan still is not in 
compliance with this section, not 
later than 7 days after such deter-
mination, shall notify all individ-
uals enrolled in the plan or cov-
erage that the plan has been deter-
mined to be not in compliance 
with this section. 
‘‘(II) EXEMPTION FROM DISCLO-
SURE.—Documents or communications 
produced in connection with the Sec-
retary’s recommendations to the plan 
or coverage shall not be subject to dis-
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closure pursuant to section 552 of title 
5, United States Code. 
‘‘(iv) REPORT.—Not later than 1 year 
after the date of enactment of this para-
graph, 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 compara-
tive analyses requested under clause 
(i), including the identity of each plan 
that is determined to be not in compli-
ance after the final determination by 
the Secretary described in clause 
(iii)(I)(bb); 
‘‘(II) the Secretary’s conclusions 
as to whether each plan submitted suf-
ficient information for the Secretary to 
review the comparative analyses re-
quested under clause (i) for compliance 
with this section; 
‘‘(III) for each plan that did sub-
mit sufficient information for the Sec-
retary to review the comparative anal-
yses requested under clause (i), the Sec-
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retary’s conclusions as to whether and 
why the plan or coverage is in compli-
ance with the requirements under this 
section; 
‘‘(IV) the Secretary’s specifica-
tions described in clause (ii) for each 
plan that the Secretary determined did 
not submit sufficient information for 
the Secretary to review the compara-
tive 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 com-
parative analyses requested under subpara-
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graph (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 guid-
ance shall include guidance to clarify the 
process and timeline for current and poten-
tial participants and beneficiaries (and au-
thorized representatives and health care 
providers of such participants and bene-
ficiaries) with respect to plans to file com-
plaints of such plans or issuers being in 
violation of this section, including guidance, 
by plan type, on the relevant State, re-
gional, or national office with which such 
complaints should be filed. 
‘‘(iii) STATE.—The Secretary shall 
share information on findings of compliance 
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and noncompliance discovered upon review-
ing 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 sub-
section (a), the paragraph (8) of section 712(a) of the Em-
ployee 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. 
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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 
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