4366 
‘‘(II) descriptions of the violations 
uncovered during the course of such in-
vestigations. 
‘‘(ii) NONQUANTITATIVE
TREATMENT 
LIMITATIONS.—To the extent that any ex-
ample described in clause (i) involves a 
finding of compliance or noncompliance 
with regard to any requirement for non-
quantitative treatment limitations, the ex-
ample shall provide sufficient detail to fully 
explain such finding, including a full de-
scription of the criteria involved for approv-
ing medical and surgical benefits and the 
criteria involved for approving mental 
health and substance use disorder benefits. 
‘‘(iii) ACCESS TO ADDITIONAL INFOR-
MATION
REGARDING
COMPLIANCE.—In de-
veloping and issuing the compliance pro-
gram 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 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04366
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4367 
of the Department of Labor, and the 
Inspector General of the Department of 
the Treasury to share findings of com-
pliance and noncompliance with this 
section, section 2726 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 infor-
mation on findings of compliance and 
noncompliance with this section, sec-
tion 2726 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 rec-
ommendations to advance compliance with this 
section, section 2726 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 mon-
itor adherence to applicable statutes, regulations, 
and program requirements. Such internal con-
trols may include illustrative examples of non-
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04367
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4368 
quantitative treatment limitations on mental 
health and substance use disorder benefits, which 
may fail to comply with this section, section 
2726 of the Public Health Service Act, or section 
9812 of the Internal Revenue Code of 1986, as 
applicable, in relation to nonquantitative treat-
ment limitations on medical and surgical bene-
fits. 
‘‘(D) UPDATING THE COMPLIANCE PROGRAM 
GUIDANCE DOCUMENT.—The Secretary, the Sec-
retary 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 Gen-
eral of the Department of Labor, and the Inspec-
tor 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 2726 of the Public Health Service Act, or 
section 9812 of the Internal Revenue Code of 
1986, as applicable. 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04368
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4369 
‘‘(7) ADDITIONAL GUIDANCE.— 
‘‘(A) IN GENERAL.—The Secretary, the Sec-
retary of Health and Human Services, and the 
Secretary of the Treasury shall issue guidance to 
group health plans and health insurance issuers 
offering group health insurance coverage to assist 
such plans and issuers in satisfying the require-
ments of this section, section 2726 of the Public 
Health Service Act, or section 9812 of the Inter-
nal Revenue Code of 1986, as applicable. 
‘‘(B) DISCLOSURE.— 
‘‘(i) 
GUIDANCE
FOR
PLANS
AND 
ISSUERS.—The guidance issued under this 
paragraph shall include clarifying informa-
tion and illustrative examples of methods 
that group health plans and health insur-
ance issuers offering group or individual 
health insurance coverage may use for dis-
closing information to ensure compliance 
with the requirements under this section, 
section 2726 of the Public Health Service 
Act, or section 9812 of the Internal Revenue 
Code of 1986, as applicable, (and any regu-
lations promulgated pursuant to such sec-
tions, as applicable). 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04369
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4370 
‘‘(ii) DOCUMENTS FOR PARTICIPANTS, 
BENEFICIARIES, CONTRACTING
PROVIDERS, 
OR
AUTHORIZED
REPRESENTATIVES.—The 
guidance issued under this paragraph shall 
include clarifying information and illus-
trative examples of methods that group 
health plans and health insurance issuers 
offering group health insurance coverage 
may use to provide any participant, bene-
ficiary, contracting provider, or authorized 
representative, as applicable, with docu-
ments containing information that the 
health plans or issuers are required to dis-
close to participants, beneficiaries, con-
tracting providers, or authorized representa-
tives to ensure compliance with this section, 
section 2726 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— 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04370
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4371 
‘‘(I) 
nonquantitative 
treatment 
limitations for both medical and sur-
gical benefits and mental health and 
substance use disorder benefits; 
‘‘(II) the processes, strategies, evi-
dentiary standards, and other factors 
used to apply the limitations described 
in subclause (I); and 
‘‘(III) the application of the limi-
tations described in subclause (I) to en-
sure that such limitations are applied 
in parity with respect to both medical 
and surgical benefits and mental 
health and substance use disorder bene-
fits. 
‘‘(C) NONQUANTITATIVE TREATMENT LIMI-
TATIONS.—The guidance issued under this para-
graph shall include clarifying information and 
illustrative examples of methods, processes, strat-
egies, evidentiary standards, and other factors 
that group health plans and health insurance 
issuers offering group health insurance coverage 
may use regarding the development and applica-
tion of nonquantitative treatment limitations to 
ensure compliance with this section, section 2726 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04371
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4372 
of the Public Health Service Act, or section 9812 
of the Internal Revenue Code of 1986, as appli-
cable, (and any regulations promulgated pursu-
ant 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 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04372
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4373 
‘‘(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; 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04373
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4374 
‘‘(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 2726 of the Public 
Health Service Act, or section 9812 of the 
Internal Revenue Code of 1986, as applica-
ble. 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04374
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4375 
‘‘(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.—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 lim-
itations (referred to in this section as ‘NQTLs’) 
on mental health or substance use disorder bene-
fits, such plan or issuer shall perform and docu-
ment comparative analyses of the design and ap-
plication of NQTLs and, beginning 45 days after 
the date of enactment of the Consolidated Appro-
priations Act, 2021, make available to the Sec-
retary, upon request, the comparative analyses 
and the following information: 
‘‘(i) The specific plan or coverage 
terms or other relevant terms regarding the 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04375
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4376 
NQTLs, that applies to such plan or cov-
erage, and a description of all mental health 
or substance use disorder and medical or 
surgical benefits to which each such term 
applies in each respective benefits classifica-
tion. 
‘‘(ii) The factors used to determine that 
the NQTLs 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 NQTLs 
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 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, the 
processes, strategies, evidentiary standards, 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04376
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4377 
and other factors used to apply the NQTLs 
to medical or surgical benefits in the bene-
fits classification. 
‘‘(v) The specific findings and conclu-
sions reached by the group health plan or 
health insurance issuer with respect to the 
health insurance coverage, including any re-
sults of the analyses described in this sub-
paragraph that indicate that the plan or 
coverage is or is not 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 of-
fering group health insurance coverage sub-
mit the comparative analyses described in 
subparagraph (A) for plans that involve po-
tential violations of this section or com-
plaints 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. 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04377
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4378 
‘‘(ii) ADDITIONAL
INFORMATION.—In 
instances in which the Secretary has con-
cluded that the group health plan or health 
insurance issuer with respect to group 
health insurance 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 issuer the information the plan or 
issuer 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 group health plan or health insurance 
issuer is in compliance with this section 
solely based upon the inspection of the com-
parative analyses described in subpara-
graph (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 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04378
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4379 
subparagraph (A), as requested under 
clause (i), and determined that the 
group health plan or health insurance 
issuer is not in compliance with this 
section, the plan or issuer— 
‘‘(aa) shall specify to the Sec-
retary the actions the plan or 
issuer will take to be in compli-
ance with this section and provide 
to the Secretary additional com-
parative analyses described in 
subparagraph 
(A) 
that 
dem-
onstrate compliance with this sec-
tion not later than 45 days after 
the initial determination by the 
Secretary that the plan or issuer 
is not in compliance; and 
‘‘(bb) following the 45-day 
corrective action period under 
item (aa), if the Secretary makes 
a final determination that the 
plan or issuer still is not in com-
pliance with this section, not later 
than 7 days after such determina-
tion, shall notify all individuals 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04379
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4380 
enrolled in the plan or applicable 
health insurance coverage offered 
by the issuer that the plan or 
issuer, with respect to such cov-
erage, has been determined to be 
not in compliance with this sec-
tion. 
‘‘(II) EXEMPTION FROM DISCLO-
SURE.—Documents or communications 
produced in connection with the Sec-
retary’s recommendations to a group 
health plan or health insurance issuer 
shall not be subject to disclosure pursu-
ant 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 
group health plan or health insurance 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04380
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4381 
issuer, with respect to certain health 
insurance coverage that is determined 
to be not in compliance after the final 
determination by the Secretary de-
scribed in clause (iii)(I)(bb); 
‘‘(II) the Secretary’s conclusions 
as to whether each group health plan 
or health insurance issuer submitted 
sufficient information for the Secretary 
to review the comparative analyses re-
quested under clause (i) for compliance 
with this section; 
‘‘(III) for each group health plan 
or health insurance issuer that did sub-
mit sufficient information for the Sec-
retary to review the comparative anal-
yses requested under clause (i), the Sec-
retary’s conclusions as to whether and 
why the plan or issuer is in compli-
ance with the disclosure requirements 
under this section; 
‘‘(IV) the Secretary’s specifica-
tions described in clause (ii) for each 
group health plan or health insurance 
issuer that the Secretary determined 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04381
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4382 
did not submit sufficient information 
for the Secretary to review the com-
parative 
analyses 
requested 
under 
clause (i) for compliance with this sec-
tion; and 
‘‘(V) the Secretary’s specifications 
described in clause (iii) of the actions 
each group health plan or health insur-
ance issuer that the Secretary deter-
mined 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 issuer 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-
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 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04382
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4383 
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 
and noncompliance discovered upon review-
ing the comparative analyses requested 
under subparagraph (B)(i) shall be shared 
with the State where the group health plan 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04383
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4384 
is located or the State where the health in-
surance 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).’’. 
(3) IRC.—Section 9812(a) of the Internal Rev-
enue Code of 1986 is amended by adding at the end 
the following: 
‘‘(6) COMPLIANCE
PROGRAM
GUIDANCE
DOCU-
MENT.— 
‘‘(A) IN GENERAL.—The Secretary, the Sec-
retary of Health and Human Services, and the 
Secretary of Labor, in consultation with the In-
spector 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 
2726 of the Public Health Service Act, and sec-
tion 712 of the Employee Retirement Income Se-
curity Act of 1974, 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 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04384
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133
4385 
the Department of Labor, entitled ‘Warning 
Signs - Plan or Policy Non-Quantitative Treat-
ment Limitations (NQTLs) that Require Addi-
tional 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 indi-
vidually identifiable information) of pre-
vious findings of compliance and non-
compliance with this section, section 2726 of 
the Public Health Service Act, or section 
712 of the Employee Retirement Income Se-
curity Act of 1974, as applicable, based on 
investigations of violations of such sections, 
including— 
‘‘(I) examples illustrating require-
ments for information disclosures and 
nonquantitative treatment limitations; 
and 
VerDate Sep 11 2014 
22:37 Dec 23, 2020
Jkt 000000
PO 00000
Frm 04385
Fmt 6652
Sfmt 6203
Z:\116\ENGROSS\H133.EAH
h133