H. R. 133—1711 
pursuant to section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996, the amendments made by the 
Genetic Information Nondiscrimination Act of 2008, and the 
Americans with Disabilities Act of 1990.’’. 
(b) ERISA.—Subpart B of part 7 of subtitle B of title I of 
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1185 et seq.), as amended by title I, is further amended by adding 
at the end the following: 
‘‘SEC. 724. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES 
ON PRICE AND QUALITY INFORMATION. 
‘‘(a) INCREASING PRICE AND QUALITY TRANSPARENCY FOR PLAN 
SPONSORS AND CONSUMERS.— 
‘‘(1) IN GENERAL.—A group health plan (or an issuer of 
health insurance coverage offered in connection with such a 
plan) may not enter into an agreement with a health care 
provider, network or association of providers, third-party 
administrator, or other service provider offering access to a 
network of providers that would directly or indirectly restrict 
a group health plan or health insurance issuer offering such 
coverage from— 
‘‘(A) providing provider-specific cost or quality of care 
information or data, through a consumer engagement tool 
or any other means, to referring providers, the plan 
sponsor, participants or beneficiaries, or individuals eligible 
to become participants or beneficiaries of the plan or cov-
erage; 
‘‘(B) electronically accessing de-identified claims and 
encounter information or data for each participant or bene-
ficiary in the plan or coverage, upon request and consistent 
with the privacy regulations promulgated pursuant to sec-
tion 264(c) of the Health Insurance Portability and Account-
ability Act of 1996, the amendments made by the Genetic 
Information Nondiscrimination Act of 2008, and the Ameri-
cans with Disabilities Act of 1990, including, on a per 
claim basis— 
‘‘(i) financial information, such as the allowed 
amount, or any other claim-related financial obliga-
tions included in the provider contract; 
‘‘(ii) provider information, including name and clin-
ical designation; 
‘‘(iii) service codes; or 
‘‘(iv) any other data element included in claim 
or encounter transactions; or 
‘‘(C) sharing information or data described in subpara-
graph (A) or (B), or directing that such data be shared, 
with a business associate as defined in section 160.103 
of title 45, Code of Federal Regulations (or successor regula-
tions), consistent with the privacy regulations promulgated 
pursuant to section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996, the amendments 
made by the Genetic Information Nondiscrimination Act 
of 2008, and the Americans with Disabilities Act of 1990. 
‘‘(2) CLARIFICATION
REGARDING
PUBLIC
DISCLOSURE
OF 
INFORMATION.—Nothing in paragraph (1)(A) prevents a health 
care provider, network or association of providers, or other 
service provider from placing reasonable restrictions on the
H. R. 133—1712 
public disclosure of the information described in such paragraph 
(1). 
‘‘(3) ATTESTATION.—A group health plan (or health insur-
ance coverage offered in connection with such a plan) shall 
annually submit to the Secretary an attestation that such plan 
or issuer of such coverage is in compliance with the require-
ments of this subsection. 
‘‘(4) RULES OF CONSTRUCTION.—Nothing in this section shall 
be construed to modify or eliminate existing privacy protections 
and standards under State and Federal law. Nothing in this 
subsection shall be construed to otherwise limit access by a 
group health plan, plan sponsor, or health insurance issuer 
to data as permitted under the privacy regulations promulgated 
pursuant to section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996, the amendments made by the 
Genetic Information Nondiscrimination Act of 2008, and the 
Americans with Disabilities Act of 1990.’’. 
(c) IRC.—Subchapter B of chapter 100 of the Internal Revenue 
Code of 1986, as amended by title I, is further amended by adding 
at the end the following: 
‘‘SEC. 9824. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES 
ON PRICE AND QUALITY INFORMATION. 
‘‘(a) INCREASING PRICE AND QUALITY TRANSPARENCY FOR PLAN 
SPONSORS AND CONSUMERS.— 
‘‘(1) IN GENERAL.—A group health plan may not enter into 
an agreement with a health care provider, network or associa-
tion of providers, third-party administrator, or other service 
provider offering access to a network of providers that would 
directly or indirectly restrict a group health plan from— 
‘‘(A) providing provider-specific cost or quality of care 
information or data, through a consumer engagement tool 
or any other means, to referring providers, the plan 
sponsor, participants or beneficiaries, or individuals eligible 
to become participants or beneficiaries of the plan; 
‘‘(B) electronically accessing de-identified claims and 
encounter information or data for each participant or bene-
ficiary in the plan, upon request and consistent with the 
privacy regulations promulgated pursuant to section 264(c) 
of the Health Insurance Portability and Accountability Act 
of 1996, the amendments made by the Genetic Information 
Nondiscrimination Act of 2008, and the Americans with 
Disabilities Act of 1990, including, on a per claim basis— 
‘‘(i) financial information, such as the allowed 
amount, or any other claim-related financial obliga-
tions included in the provider contract; 
‘‘(ii) provider information, including name and clin-
ical designation; 
‘‘(iii) service codes; or 
‘‘(iv) any other data element included in claim 
or encounter transactions; or 
‘‘(C) sharing information or data described in subpara-
graph (A) or (B), or directing that such data be shared, 
with a business associate as defined in section 160.103 
of title 45, Code of Federal Regulations (or successor regula-
tions), consistent with the privacy regulations promulgated
H. R. 133—1713 
pursuant to section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996, the amendments 
made by the Genetic Information Nondiscrimination Act 
of 2008, and the Americans with Disabilities Act of 1990. 
‘‘(2) CLARIFICATION
REGARDING
PUBLIC
DISCLOSURE
OF 
INFORMATION.—Nothing in paragraph (1)(A) prevents a health 
care provider, network or association of providers, or other 
service provider from placing reasonable restrictions on the 
public disclosure of the information described in such paragraph 
(1). 
‘‘(3) ATTESTATION.—A group health plan shall annually 
submit to the Secretary an attestation that such plan is in 
compliance with the requirements of this subsection. 
‘‘(4) RULES OF CONSTRUCTION.—Nothing in this section shall 
be construed to modify or eliminate existing privacy protections 
and standards under State and Federal law. Nothing in this 
subsection shall be construed to otherwise limit access by a 
group health plan or plan sponsor to data as permitted under 
the privacy regulations promulgated pursuant to section 264(c) 
of the Health Insurance Portability and Accountability Act of 
1996, the amendments made by the Genetic Information Non-
discrimination Act of 2008, and the Americans with Disabilities 
Act of 1990.’’. 
(d) CLERICAL AMENDMENTS.— 
(1) ERISA.—The table of contents in section 1 of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1001 et seq.), as amended by title I, is further amended by 
inserting after the item relating to section 723 the following 
new item: 
‘‘Sec. 724. Increasing transparency by removing gag clauses on price and quality in-
formation.’’. 
(2) IRC.—The table of sections for subchapter B of chapter 
100 of the Internal Revenue Code of 1986, as amended by 
title I, is further amended by adding at the end the following 
new item: 
‘‘Sec. 9824. Increasing transparency by removing gag clauses on price and quality 
information.’’. 
SEC. 202. DISCLOSURE OF DIRECT AND INDIRECT COMPENSATION FOR 
BROKERS 
AND 
CONSULTANTS 
TO 
EMPLOYER-SPON-
SORED HEALTH PLANS AND ENROLLEES IN PLANS ON 
THE INDIVIDUAL MARKET. 
(a) GROUP HEALTH PLANS.—Section 408(b)(2) of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) 
is amended— 
(1) by striking ‘‘(2) Contracting or making’’ and inserting 
‘‘(2)(A) Contracting or making’’; and 
(2) by adding at the end the following: 
‘‘(B)(i) No contract or arrangement for services between 
a covered plan and a covered service provider, and no extension 
or renewal of such a contract or arrangement, is reasonable 
within the meaning of this paragraph unless the requirements 
of this clause are met. 
‘‘(ii)(I) For purposes of this subparagraph:
H. R. 133—1714 
‘‘(aa) The term ‘covered plan’ means a group health 
plan as defined section 733(a). 
‘‘(bb) The term ‘covered service provider’ means a 
service provider that enters into a contract or arrangement 
with the covered plan and reasonably expects $1,000 (or 
such amount as the Secretary may establish in regulations 
to account for inflation since the date of enactment of 
the Consolidated Appropriations Act, 2021, as appropriate) 
or more in compensation, direct or indirect, to be received 
in connection with providing one or more of the following 
services, pursuant to the contract or arrangement, regard-
less of whether such services will be performed, or such 
compensation received, by the covered service provider, 
an affiliate, or a subcontractor: 
‘‘(AA) Brokerage services, for which the covered 
service provider, an affiliate, or a subcontractor reason-
ably expects to receive indirect compensation or direct 
compensation described in item (dd), provided to a 
covered plan with respect to selection of insurance 
products (including vision and dental), recordkeeping 
services, 
medical 
management 
vendor, 
benefits 
administration (including vision and dental), stop-loss 
insurance, pharmacy benefit management services, 
wellness services, transparency tools and vendors, 
group purchasing organization preferred vendor panels, 
disease management vendors and products, compliance 
services, employee assistance programs, or third party 
administration services. 
‘‘(BB) Consulting, for which the covered service 
provider, an affiliate, or a subcontractor reasonably 
expects to receive indirect compensation or direct com-
pensation described in item (dd), related to the develop-
ment or implementation of plan design, insurance or 
insurance product selection (including vision and 
dental), recordkeeping, medical management, benefits 
administration selection (including vision and dental), 
stop-loss insurance, pharmacy benefit management 
services, wellness design and management services, 
transparency tools, group purchasing organization 
agreements and services, participation in and services 
from preferred vendor panels, disease management, 
compliance services, employee assistance programs, or 
third party administration services. 
‘‘(cc) The term ‘affiliate’, with respect to a covered 
service provider, means an entity that directly or indirectly 
(through one or more intermediaries) controls, is controlled 
by, or is under common control with, such provider, or 
is an officer, director, or employee of, or partner in, such 
provider. 
‘‘(dd)(AA) The term ‘compensation’ means anything of 
monetary value, but does not include non-monetary com-
pensation valued at $250 (or such amount as the Secretary 
may establish in regulations to account for inflation since 
the date of enactment of the Consolidated Appropriations 
Act, 2021, as appropriate) or less, in the aggregate, during 
the term of the contract or arrangement.
H. R. 133—1715 
‘‘(BB) The term ‘direct compensation’ means compensa-
tion received directly from a covered plan. 
‘‘(CC) The term ‘indirect compensation’ means com-
pensation received from any source other than the covered 
plan, the plan sponsor, the covered service provider, or 
an affiliate. Compensation received from a subcontractor 
is indirect compensation, unless it is received in connection 
with services performed under a contract or arrangement 
with a subcontractor. 
‘‘(ee) The term ‘responsible plan fiduciary’ means a 
fiduciary with authority to cause the covered plan to enter 
into, or extend or renew, the contract or arrangement. 
‘‘(ff) The term ‘subcontractor’ means any person or 
entity (or an affiliate of such person or entity) that is 
not an affiliate of the covered service provider and that, 
pursuant to a contract or arrangement with the covered 
service provider or an affiliate, reasonably expects to 
receive $1,000 (or such amount as the Secretary may estab-
lish in regulations to account for inflation since the date 
of enactment of the Consolidated Appropriations Act, 2021, 
as appropriate) or more in compensation for performing 
one or more services described in item (bb) under a contract 
or arrangement with the covered plan. 
‘‘(II) For purposes of this subparagraph, a description of 
compensation or cost may be expressed as a monetary amount, 
formula, or a per capita charge for each enrollee or, if the 
compensation or cost cannot reasonably be expressed in such 
terms, by any other reasonable method, including a disclosure 
that additional compensation may be earned but may not be 
calculated at the time of contract if such a disclosure includes 
a description of the circumstances under which the additional 
compensation may be earned and a reasonable and good faith 
estimate if the covered service provider cannot otherwise readily 
describe compensation or cost and explains the methodology 
and assumptions used to prepare such estimate. Any such 
description shall contain sufficient information to permit 
evaluation of the reasonableness of the compensation or cost. 
‘‘(III) No person or entity is a ‘covered service provider’ 
within the meaning of subclause (I)(bb) solely on the basis 
of providing services as an affiliate or a subcontractor that 
is performing one or more of the services described in subitem 
(AA) or (BB) of such subclause under the contract or arrange-
ment with the covered plan. 
‘‘(iii) A covered service provider shall disclose to a respon-
sible plan fiduciary, in writing, the following: 
‘‘(I) A description of the services to be provided to 
the covered plan pursuant to the contract or arrangement. 
‘‘(II) If applicable, a statement that the covered service 
provider, an affiliate, or a subcontractor will provide, or 
reasonably expects to provide, services pursuant to the 
contract or arrangement directly to the covered plan as 
a fiduciary (within the meaning of section 3(21)). 
‘‘(III) A description of all direct compensation, either 
in the aggregate or by service, that the covered service 
provider, an affiliate, or a subcontractor reasonably expects 
to receive in connection with the services described in 
subclause (I).
H. R. 133—1718 
‘‘(gg) a description of the information that the covered 
service provider failed to disclose; 
‘‘(hh) the date on which such information was requested 
in writing from the covered service provider; and 
‘‘(ii) a statement as to whether the covered service 
provider continues to provide services to the plan. 
‘‘(III) A notice described in subclause (I)(cc) shall be filed 
with the Department not later than 30 days following the 
earlier of— 
‘‘(aa) The covered service provider’s refusal to furnish 
the information requested by the written request described 
in subclause (I)(bb); or 
‘‘(bb) 90 days after the written request referred to 
in subclause (I)(cc) is made. 
‘‘(IV) If the covered service provider fails to comply with 
the written request under subclause (I)(bb) within 90 days 
of such request, the responsible plan fiduciary shall determine 
whether to terminate or continue the contract or arrangement 
under section 404. If the requested information relates to future 
services and is not disclosed promptly after the end of the 
90-day period, the responsible plan fiduciary shall terminate 
the contract or arrangement as expeditiously as possible, con-
sistent with such duty of prudence. 
‘‘(ix) Nothing in this subparagraph shall be construed to 
supersede any provision of State law that governs disclosures 
by parties that provide the services described in this section, 
except to the extent that such law prevents the application 
of a requirement of this section.’’. 
(b) APPLICABILITY OF EXISTING REGULATIONS.—Nothing in the 
amendments made by subsection (a) shall be construed to affect 
the applicability of section 2550.408b–2 of title 29, Code of Federal 
Regulations (or any successor regulations), with respect to any 
applicable entity other than a covered plan or a covered service 
provider (as defined in section 408(b)(2)(B)(ii) of the Employee 
Retirement Income Security Act of 1974, as amended by subsection 
(a)). 
(c) INDIVIDUAL MARKET COVERAGE.—Subpart 1 of part B of 
title XXVII of the Public Health Service Act (42 U.S.C. 300gg– 
41 et seq.) is amended by adding at the end the following: 
‘‘SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL MARKET COV-
ERAGE. 
‘‘(a) IN GENERAL.—A health insurance issuer offering individual 
health insurance coverage or a health insurance issuer offering 
short-term limited duration insurance coverage shall make disclo-
sures to enrollees in such coverage, as described in subsection 
(b), and reports to the Secretary, as described in subsection (c), 
regarding direct or indirect compensation provided by the issuer 
to an agent or broker associated with enrolling individuals in such 
coverage. 
‘‘(b) DISCLOSURE.—A health insurance issuer described in sub-
section (a) shall disclose to an enrollee the amount of direct or 
indirect compensation provided to an agent or broker for services 
provided by such agent or broker associated with plan selection 
and enrollment. Such disclosure shall be— 
‘‘(1) made prior to the individual finalizing plan selection; 
and
H. R. 133—1719 
‘‘(2) included on any documentation confirming the individ-
ual’s enrollment. 
‘‘(c) REPORTING.—A health insurance issuer described in sub-
section (a) shall annually report to the Secretary, prior to the 
beginning of open enrollment, any direct or indirect compensation 
provided to an agent or broker associated with enrolling individuals 
in such coverage. 
‘‘(d) RULEMAKING.—Not later than 1 year after the date of 
enactment of the Consolidated Appropriations Act, 2021, the Sec-
retary shall finalize, through notice-and-comment rulemaking, the 
timing, form, and manner in which issuers described in subsection 
(a) are required to make the disclosures described in subsection 
(b) and the reports described in subsection (c). Such rulemaking 
may also include adjustments to notice requirements to reflect 
the different processes for plan renewals, in order to provide 
enrollees with full, timely information.’’. 
(d) TRANSITION RULE.—No contract executed prior to the effec-
tive date described in subsection (e) by a group health plan subject 
to the requirements of section 408(b)(2)(B) of the Employee Retire-
ment Income Security Act of 1974 (as amended by subsection (a)) 
or by a health insurance issuer subject to the requirements of 
section 2746 of the Public Health Service Act (as added by sub-
section (c)) shall be subject to the requirements of such section 
408(b)(2)(B) or such section 2746, as applicable. 
(e) APPLICATION.—The amendments made by subsections (a) 
and (c) shall apply beginning 1 year after the date of enactment 
of this Act. 
SEC. 203. STRENGTHENING PARITY IN MENTAL HEALTH AND SUB-
STANCE USE DISORDER BENEFITS. 
(a) IN GENERAL.— 
(1) PHSA.—Section 2726(a) of the Public Health Service 
Act (42 U.S.C. 300gg–26(a)) is amended by adding at the end 
the following: 
‘‘(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 dis-
order benefits and that imposes nonquantitative treatment 
limitations (referred to in this section as ‘NQTLs’) on 
mental health or substance use disorder benefits, such 
plan or issuer shall perform and document comparative 
analyses of the design and application of NQTLs and, begin-
ning 45 days after the date of enactment of the Consoli-
dated Appropriations Act, 2021, make available to the 
applicable State authority (or, as applicable, to the Sec-
retary of Labor or the Secretary of Health and Human 
Services), upon request, the comparative analyses and the 
following information: 
‘‘(i) The specific plan or coverage terms or other 
relevant terms regarding the NQTLs 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 classification.
H. R. 133—1720 
‘‘(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 demonstrating that 
the processes, strategies, evidentiary standards, and 
other factors used to apply the NQTLs to mental health 
or substance use disorder benefits, as written and in 
operation, are comparable to, and are applied no more 
stringently than, the processes, strategies, evidentiary 
standards, and other factors used to apply the NQTLs 
to medical or surgical benefits in the benefits classifica-
tion. 
‘‘(v) The specific findings and conclusions reached 
by the group health plan or health insurance issuer 
with respect to the health insurance coverage, 
including any results of the analyses described in this 
subparagraph 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 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 group 
health plan or health insurance issuer with respect 
to health insurance coverage has not submitted suffi-
cient 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 para-
graph 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 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 group health
H. R. 133—1721 
plan or health insurance issuer is not in compli-
ance with this section, the plan or issuer— 
‘‘(aa) shall specify to the Secretary the 
actions the plan or issuer will take to be in 
compliance with this section and provide to 
the Secretary additional comparative analyses 
described in subparagraph (A) that dem-
onstrate compliance with this section 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 compliance with this section, 
not later than 7 days after such determination, 
shall notify all individuals enrolled in the plan 
or applicable health insurance coverage offered 
by the issuer that the plan or issuer, with 
respect to such coverage, has been determined 
to be not in compliance with this section. 
‘‘(II) EXEMPTION
FROM
DISCLOSURE.—Docu-
ments or communications produced in connection 
with the Secretary’s recommendations to a group 
health plan or health insurance issuer 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 group health plan or health insurance 
issuer, with respect to particular health insurance 
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 group health plan or health insurance issuer 
submitted sufficient information for the Secretary 
to review the comparative analyses requested 
under clause (i) for compliance with this section; 
‘‘(III) for each group health plan or health 
insurance 
issuer 
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 issuer is in compliance with the 
requirements under this section; 
‘‘(IV) the Secretary’s specifications described 
in clause (ii) for each group health plan or health 
insurance issuer that the Secretary determined 
did not submit sufficient information for the Sec-
retary 
to 
review 
the 
comparative 
analyses
H. R. 133—1722 
requested under clause (i) for compliance with this 
section; and 
‘‘(V) the Secretary’s specifications described in 
clause (iii) of the actions each group health plan 
or health insurance issuer 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 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 dis-
covers 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 para-
graph, 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 pro-
viders 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 informa-
tion on findings of compliance and noncompliance 
discovered upon reviewing the comparative analyses 
requested under subparagraph (B)(i) shall be shared 
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).’’. 
(2) ERISA.—Section 712(a) of the Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 1185a(a)) is amended 
by adding at the end the following: 
‘‘(6) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.— 
‘‘(A) IN
GENERAL.—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 2726 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
H. R. 133—1726 
by such plans or issuers in performing a nonquantita-
tive 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 stand-
ards may be applied to each service category or classi-
fication of benefits; 
‘‘(vii) examples of methods of reaching appropriate 
coverage determinations for new mental health or sub-
stance use disorder treatments, such as evidence-based 
early intervention programs for individuals with a 
serious mental illness and types of medical manage-
ment techniques; 
‘‘(viii) examples of methods of reaching appropriate 
coverage determinations for which there is an indirect 
relationship between the covered mental health or sub-
stance use disorder benefit and a traditional covered 
medical and surgical benefit, such as residential treat-
ment or hospitalizations involving voluntary or invol-
untary commitment; and 
‘‘(ix) additional illustrative examples of methods, 
processes, strategies, evidentiary standards, and other 
factors for which the Secretary determines that addi-
tional guidance 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 applicable. 
‘‘(D) PUBLIC COMMENT.—Prior to issuing any final guid-
ance 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 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 ‘NQTLs’) on mental health 
or substance use disorder benefits, such plan or issuer 
shall perform and document comparative analyses of the 
design and application of NQTLs and, beginning 45 days 
after the date of enactment of the Consolidated Appropria-
tions Act, 2021, make available to the Secretary, upon 
request, the comparative analyses and the following 
information: 
‘‘(i) The specific plan or coverage terms or other 
relevant terms regarding the NQTLs, that applies to 
such plan or coverage, and a description of all mental 
health or substance use disorder and medical or sur-
gical benefits to which each such term applies in each 
respective benefits classification. 
‘‘(ii) The factors used to determine that the NQTLs 
will apply to mental health or substance use disorder 
benefits and medical or surgical benefits.
H. R. 133—1727 
‘‘(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 demonstrating that 
the processes, strategies, evidentiary standards, and 
other factors used to apply the NQTLs to mental health 
or substance use disorder benefits, as written and in 
operation, are comparable to, and are applied no more 
stringently than, the processes, strategies, evidentiary 
standards, and other factors used to apply the NQTLs 
to medical or surgical benefits in the benefits classifica-
tion. 
‘‘(v) The specific findings and conclusions reached 
by the group health plan or health insurance issuer 
with respect to the health insurance coverage, 
including any results of the analyses described in this 
subparagraph 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 offering group health insurance cov-
erage submit the comparative analyses described in 
subparagraph (A) for plans that involve potential viola-
tions of this section or complaints regarding noncompli-
ance 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 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 para-
graph 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 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 group health 
plan or health insurance issuer is not in compli-
ance with this section, the plan or issuer—
H. R. 133—1728 
‘‘(aa) shall specify to the Secretary the 
actions the plan or issuer will take to be in 
compliance with this section and provide to 
the Secretary additional comparative analyses 
described in subparagraph (A) that dem-
onstrate compliance with this section 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 compliance with this section, 
not later than 7 days after such determination, 
shall notify all individuals enrolled in the plan 
or applicable health insurance coverage offered 
by the issuer that the plan or issuer, with 
respect to such coverage, has been determined 
to be not in compliance with this section. 
‘‘(II) EXEMPTION
FROM
DISCLOSURE.—Docu-
ments or communications produced in connection 
with the Secretary’s recommendations to a group 
health plan or health insurance issuer 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 group health plan or health insurance 
issuer, with respect to certain health insurance 
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 group health plan or health insurance issuer 
submitted sufficient information for the Secretary 
to review the comparative analyses requested 
under clause (i) for compliance with this section; 
‘‘(III) for each group health plan or health 
insurance 
issuer 
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 issuer is in compliance with the disclo-
sure requirements under this section; 
‘‘(IV) the Secretary’s specifications described 
in clause (ii) for each group health plan or health 
insurance issuer that the Secretary determined 
did not submit sufficient information for the Sec-
retary 
to 
review 
the 
comparative 
analyses 
requested under clause (i) for compliance with this 
section; and
H. R. 133—1729 
‘‘(V) the Secretary’s specifications described in 
clause (iii) of the actions each group health plan 
or health insurance issuer 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 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 dis-
covers 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 para-
graph, 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 pro-
viders 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 informa-
tion on findings of compliance and noncompliance 
discovered upon reviewing the comparative analyses 
requested under subparagraph (B)(i) shall be shared 
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).’’. 
(3) IRC.—Section 9812(a) of the Internal Revenue Code 
of 1986 is amended by adding at the end the following: 
‘‘(6) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.— 
‘‘(A) IN
GENERAL.—The Secretary, the Secretary of 
Health and Human Services, and the Secretary of Labor, 
in consultation with the Inspector General of the Depart-
ment 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 section 712 of the Employee Retirement Income 
Security 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 the Department of Labor, entitled
H. R. 133—1730 
‘Warning Signs - Plan or Policy Non-Quantitative Treat-
ment Limitations (NQTLs) that Require Additional Anal-
ysis to Determine Mental Health Parity Compliance’. 
‘‘(B) EXAMPLES ILLUSTRATING COMPLIANCE AND NON-
COMPLIANCE.— 
‘‘(i) IN GENERAL.—The compliance program guid-
ance document required under this paragraph shall 
provide illustrative, de-identified examples (that do not 
disclose any protected health information or individ-
ually identifiable information) of previous findings of 
compliance and noncompliance with this section, sec-
tion 2726 of the Public Health Service Act, or section 
712 of the Employee Retirement Income Security Act 
of 1974, as applicable, based on investigations of viola-
tions of such sections, including— 
‘‘(I) examples illustrating requirements for 
information disclosures and nonquantitative treat-
ment 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 suffi-
cient 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 dis-
order 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 2726 of the Public Health 
Service Act, or section 712 of the Employee Retire-
ment Income Security Act of 1974, 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 2726 of the Public Health Service Act, or 
section 712 of the Employee Retirement Income 
Security Act of 1974, as applicable. 
‘‘(C) RECOMMENDATIONS.—The compliance program 
guidance document shall include recommendations to 
advance compliance with this section, section 2726 of the 
Public Health Service Act, or section 712 of the Employee 
Retirement Income Security Act of 1974, as applicable, 
and encourage the development and use of internal controls
H. R. 133—1733 
‘‘(vi) examples of how specific evidentiary stand-
ards may be applied to each service category or classi-
fication of benefits; 
‘‘(vii) examples of methods of reaching appropriate 
coverage determinations for new mental health or sub-
stance use disorder treatments, such as evidence-based 
early intervention programs for individuals with a 
serious mental illness and types of medical manage-
ment techniques; 
‘‘(viii) examples of methods of reaching appropriate 
coverage determinations for which there is an indirect 
relationship between the covered mental health or sub-
stance use disorder benefit and a traditional covered 
medical and surgical benefit, such as residential treat-
ment or hospitalizations involving voluntary or invol-
untary commitment; and 
‘‘(ix) additional illustrative examples of methods, 
processes, strategies, evidentiary standards, and other 
factors for which the Secretary determines that addi-
tional guidance is necessary to improve compliance 
with this section, section 2726 of the Public Health 
Service Act, or section 712 of the Employee Retirement 
Income Security Act of 1974, as applicable. 
‘‘(D) PUBLIC COMMENT.—Prior to issuing any final guid-
ance 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 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 ‘NQTLs’) on mental health or substance use 
disorder benefits, such plan shall perform and document 
comparative analyses of the design and application of 
NQTLs and, beginning 45 days after the date of enactment 
of the Consolidated Appropriations Act, 2021, make avail-
able to the Secretary, upon request, the comparative anal-
yses and the following information: 
‘‘(i) The specific plan terms or other relevant terms 
regarding the NQTLs and a description of all mental 
health or substance use disorder and medical or sur-
gical benefits to which each such term applies in each 
respective benefits classification. 
‘‘(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 demonstrating that 
the processes, strategies, evidentiary standards, and
H. R. 133—1734 
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, and other factors used to apply the NQTLs 
to medical or surgical benefits in the benefits classifica-
tion. 
‘‘(v) A disclosure of the specific findings and conclu-
sions reached by the group health plan, including any 
results of the analyses described in this subparagraph 
that indicate that the plan 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 submit the 
comparative analyses described in subparagraph (A) 
for plans that involve potential violations of this section 
or complaints regarding noncompliance with this sec-
tion that concern NQTLs and any other instances in 
which the Secretary determines appropriate. The Sec-
retary shall request not fewer than 20 such analyses 
per year. 
‘‘(ii) ADDITIONAL
INFORMATION.—In instances in 
which the Secretary has concluded that the group 
health 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 must submit to be responsive 
to the request under clause (i) for the Secretary to 
review the comparative analyses described in subpara-
graph (A) for compliance with this section. Nothing 
in this paragraph shall require the Secretary to con-
clude that a group health 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 group health 
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 
additional comparative analyses described in 
subparagraph (A) that demonstrate compli-
ance with this section not later than 45 days 
after the initial determination by the Sec-
retary that the plan 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 still is 
not in compliance with this section, not later 
than 7 days after such determination, shall
H. R. 133—1735 
notify all individuals enrolled in the plan that 
the plan has been determined to be not in 
compliance with this section. 
‘‘(II) EXEMPTION
FROM
DISCLOSURE.—Docu-
ments or communications produced in connection 
with the Secretary’s recommendations to a group 
health plan 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 group 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 group health plan submitted sufficient 
information for the Secretary to review the 
comparative analyses requested under clause (i) 
for compliance with this section; 
‘‘(III) for each group health 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 is in compliance with the disclo-
sure requirements under this section; 
‘‘(IV) the Secretary’s specifications described 
in clause (ii) for each group health 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 group health plan 
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 is not in compli-
ance. 
‘‘(C) COMPLIANCE
PROGRAM
GUIDANCE
DOCUMENT 
UPDATE PROCESS.— 
‘‘(i) IN
GENERAL.—The Secretary shall include 
instances of noncompliance that the Secretary dis-
covers 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 para-
graph, the Secretary shall finalize any draft or interim 
guidance and regulations relating to mental health
H. R. 133—1736 
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 pro-
viders of such participants and beneficiaries) with 
respect to plans to file complaints of such plans 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 informa-
tion on findings of compliance and noncompliance 
discovered upon reviewing the comparative analyses 
requested under subparagraph (B)(i) shall be shared 
with the State where the group health plan is located, 
in accordance with paragraph (6)(B)(iii)(II).’’. 
(4) MEDICAID AND CHIP COMPLIANCE.— 
(A) MEDICAID MANAGED CARE ORGANIZATIONS.—Section 
1932(b)(8) of the Social Security Act (42 U.S.C. 1396u– 
2(b)(8)) is amended by adding at the end the following 
new sentence: ‘‘In applying the previous sentence with 
respect to requirements under paragraph (8) of section 
2726(a) of the Public Health Service Act, a Medicaid man-
aged care organization (or a prepaid inpatient health plan 
(as defined by the Secretary) or prepaid ambulatory health 
plan (as defined by the Secretary) that offers services to 
enrollees of a Medicaid managed care organization) shall 
be treated as in compliance with such requirements if 
the Medicaid managed care organization (or prepaid 
inpatient health plan or prepaid ambulatory health plan) 
is in compliance with subpart K of part 438 of title 42, 
Code of Federal Regulations, and section 438.3(n) of such 
title, or any successor regulation.’’. 
(B) OTHER BENCHMARK BENEFIT PACKAGES OR BENCH-
MARK
EQUIVALENT
COVERAGE.—Section 1937(b)(6)(A) of 
such Act (42 U.S.C. 1396u–7(b)(6)(A)) is amended— 
(i) by striking ‘‘section 2705(a)’’ and inserting ‘‘sec-
tion 2726(a)’’; and 
(ii) by adding at the end the following new sen-
tence: ‘‘In applying the previous sentence with respect 
to requirements under paragraph (8) of section 2726(a) 
of the Public Health Service Act, a benchmark benefit 
package or benchmark equivalent coverage described 
in such sentence shall be treated as in compliance 
with such requirements if the State plan under this 
title or the benchmark benefit package or benefit 
equivalent coverage, as applicable, is in compliance 
with subpart C of part 440 of title 42, Code of Federal 
Regulations, or any successor regulation.’’. 
(C) STATE CHILD HEALTH PLANS.—Section 2103(c)(7)(A) 
of the Social Security Act (42 U.S.C. 1397cc(c)(7)(A)) is 
amended— 
(i) by striking ‘‘section 2705(a)’’ and inserting ‘‘sec-
tion 2726(a)’’; and 
(ii) by adding at the end the following new sen-
tence: ‘‘In applying the previous sentence with respect 
to requirements under paragraph (8) of section 2726(a) 
of the Public Health Service Act, a State child health
H. R. 133—1737 
plan described in such sentence shall be treated as 
in compliance with such requirements if the State child 
health plan is in compliance with section 457.496 of 
title 42, Code of Federal Regulations, or any successor 
regulation.’’. 
(b) GUIDANCE.—The Secretary of Health and Human Services, 
jointly with the Secretary of Labor and the Secretary of the 
Treasury, shall issue guidance to carry out the amendments made 
by paragraphs (1), (2), and (3) of subsection (a). 
SEC. 204. REPORTING ON PHARMACY BENEFITS AND DRUG COSTS. 
(a) PHSA.—Part D of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg et seq.), as amended by section 201, is further 
amended by adding at the end the following: 
‘‘SEC. 2799A–10. REPORTING ON PHARMACY BENEFITS AND DRUG 
COSTS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the date of 
enactment of the Consolidated Appropriations Act, 2021, and not 
later than June 1 of each year thereafter, a group health plan 
or health insurance issuer offering group or individual health insur-
ance coverage (except for a church plan) shall submit to the Sec-
retary, the Secretary of Labor, and the Secretary of the Treasury 
the following information with respect to the health plan or coverage 
in the previous plan year: 
‘‘(1) The beginning and end dates of the plan year. 
‘‘(2) The number of enrollees. 
‘‘(3) Each State in which the plan or coverage is offered. 
‘‘(4) The 50 brand prescription drugs most frequently dis-
pensed by pharmacies for claims paid by the plan or coverage, 
and the total number of paid claims for each such drug. 
‘‘(5) The 50 most costly prescription drugs with respect 
to the plan or coverage by total annual spending, and the 
annual amount spent by the plan or coverage for each such 
drug. 
‘‘(6) The 50 prescription drugs with the greatest increase 
in plan expenditures over the plan year preceding the plan 
year that is the subject of the report, and, for each such drug, 
the change in amounts expended by the plan or coverage in 
each such plan year. 
‘‘(7) Total spending on health care services by such group 
health plan or health insurance coverage, broken down by— 
‘‘(A) the type of costs, including— 
‘‘(i) hospital costs; 
‘‘(ii) health care provider and clinical service costs, 
for primary care and specialty care separately; 
‘‘(iii) costs for prescription drugs; and 
‘‘(iv) other medical costs, including wellness serv-
ices; and 
‘‘(B) spending on prescription drugs by— 
‘‘(i) the health plan or coverage; and 
‘‘(ii) the enrollees. 
‘‘(8) The average monthly premium— 
‘‘(A) paid by employers on behalf of enrollees, as 
applicable; and 
‘‘(B) paid by enrollees. 
‘‘(9) Any impact on premiums by rebates, fees, and any 
other remuneration paid by drug manufacturers to the plan
H. R. 133—1738 
or coverage or its administrators or service providers, with 
respect to prescription drugs prescribed to enrollees in the 
plan or coverage, including— 
‘‘(A) the amounts so paid for each therapeutic class 
of drugs; and 
‘‘(B) the amounts so paid for each of the 25 drugs 
that yielded the highest amount of rebates and other remu-
neration under the plan or coverage from drug manufactur-
ers during the plan year. 
‘‘(10) Any reduction in premiums and out-of-pocket costs 
associated with rebates, fees, or other remuneration described 
in paragraph (9). 
‘‘(b) REPORT.—Not later than 18 months after the date on 
which the first report is required under subsection (a) and bian-
nually thereafter, the Secretary, acting through the Assistant Sec-
retary of Planning and Evaluation and in coordination with the 
Inspector General of the Department of Health and Human Serv-
ices, shall make available on the internet website of the Department 
of Health and Human Services a report on prescription drug 
reimbursements under group health plans and group and individual 
health insurance coverage, prescription drug pricing trends, and 
the role of prescription drug costs in contributing to premium 
increases or decreases under such plans or coverage, aggregated 
in such a way as no drug or plan specific information will be 
made public. 
‘‘(c) PRIVACY PROTECTIONS.—No confidential or trade secret 
information submitted to the Secretary under subsection (a) shall 
be included in the report under subsection (b).’’. 
(b) ERISA.—Subpart B of part 7 of subtitle B of title I of 
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1185 et seq.), as amended by section 201, is further amended 
by adding at the end the following: 
‘‘SEC. 725. REPORTING ON PHARMACY BENEFITS AND DRUG COSTS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the date of 
enactment of the Consolidated Appropriations Act, 2021, and not 
later than June 1 of each year thereafter, a group health plan 
(or health insurance coverage offered in connection with such a 
plan) shall submit to the Secretary, the Secretary of Health and 
Human Services, and the Secretary of the Treasury the following 
information with respect to the health plan or coverage in the 
previous plan year: 
‘‘(1) The beginning and end dates of the plan year. 
‘‘(2) The number of participants and beneficiaries. 
‘‘(3) Each State in which the plan or coverage is offered. 
‘‘(4) The 50 brand prescription drugs most frequently dis-
pensed by pharmacies for claims paid by the plan or coverage, 
and the total number of paid claims for each such drug. 
‘‘(5) The 50 most costly prescription drugs with respect 
to the plan or coverage by total annual spending, and the 
annual amount spent by the plan or coverage for each such 
drug. 
‘‘(6) The 50 prescription drugs with the greatest increase 
in plan expenditures over the plan year preceding the plan 
year that is the subject of the report, and, for each such drug, 
the change in amounts expended by the plan or coverage in 
each such plan year.
H. R. 133—1739 
‘‘(7) Total spending on health care services by such group 
health plan or health insurance coverage, broken down by— 
‘‘(A) the type of costs, including— 
‘‘(i) hospital costs; 
‘‘(ii) health care provider and clinical service costs, 
for primary care and specialty care separately; 
‘‘(iii) costs for prescription drugs; and 
‘‘(iv) other medical costs, including wellness serv-
ices; and 
‘‘(B) spending on prescription drugs by— 
‘‘(i) the health plan or coverage; and 
‘‘(ii) the participants and beneficiaries. 
‘‘(8) The average monthly premium— 
‘‘(A) paid by employers on behalf of participants and 
beneficiaries, as applicable; and 
‘‘(B) paid by participants and beneficiaries. 
‘‘(9) Any impact on premiums by rebates, fees, and any 
other remuneration paid by drug manufacturers to the plan 
or coverage or its administrators or service providers, with 
respect to prescription drugs prescribed to participants or bene-
ficiaries in the plan or coverage, including— 
‘‘(A) the amounts so paid for each therapeutic class 
of drugs; and 
‘‘(B) the amounts so paid for each of the 25 drugs 
that yielded the highest amount of rebates and other remu-
neration under the plan or coverage from drug manufactur-
ers during the plan year. 
‘‘(10) Any reduction in premiums and out-of-pocket costs 
associated with rebates, fees, or other remuneration described 
in paragraph (9). 
‘‘(b) REPORT.—Not later than 18 months after the date on 
which the first report is required under subsection (a) and bian-
nually thereafter, the Secretary, acting in coordination with the 
Inspector General of the Department of Labor, shall make available 
on the internet website of the Department of Labor a report on 
prescription drug reimbursements under group health plans (or 
health insurance coverage offered in connection with such a plan), 
prescription drug pricing trends, and the role of prescription drug 
costs in contributing to premium increases or decreases under such 
plans or coverage, aggregated in such a way as no drug or plan 
specific information will be made public. 
‘‘(c) PRIVACY PROTECTIONS.—No confidential or trade secret 
information submitted to the Secretary under subsection (a) shall 
be included in the report under subsection (b).’’. 
(c) IRC.—Subchapter B of chapter 100 of the Internal Revenue 
Code of 1986, as amended by section 201, is further amended 
by adding at the end the following: 
‘‘SEC. 9825. REPORTING ON PHARMACY BENEFITS AND DRUG COSTS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the date of 
enactment of the Consolidated Appropriations Act, 2021, and not 
later than June 1 of each year thereafter, a group health plan 
shall submit to the Secretary, the Secretary of Health and Human 
Services, and the Secretary of Labor the following information with 
respect to the health plan in the previous plan year: 
‘‘(1) The beginning and end dates of the plan year. 
‘‘(2) The number of participants and beneficiaries.
H. R. 133—1740 
‘‘(3) Each State in which the plan is offered. 
‘‘(4) The 50 brand prescription drugs most frequently dis-
pensed by pharmacies for claims paid by the plan, and the 
total number of paid claims for each such drug. 
‘‘(5) The 50 most costly prescription drugs with respect 
to the plan by total annual spending, and the annual amount 
spent by the plan for each such drug. 
‘‘(6) The 50 prescription drugs with the greatest increase 
in plan expenditures over the plan year preceding the plan 
year that is the subject of the report, and, for each such drug, 
the change in amounts expended by the plan in each such 
plan year. 
‘‘(7) Total spending on health care services by such group 
health plan, broken down by— 
‘‘(A) the type of costs, including— 
‘‘(i) hospital costs; 
‘‘(ii) health care provider and clinical service costs, 
for primary care and specialty care separately; 
‘‘(iii) costs for prescription drugs; and 
‘‘(iv) other medical costs, including wellness serv-
ices; and 
‘‘(B) spending on prescription drugs by— 
‘‘(i) the health plan; and 
‘‘(ii) the participants and beneficiaries. 
‘‘(8) The average monthly premium— 
‘‘(A) paid by employers on behalf of participants and 
beneficiaries, as applicable; and 
‘‘(B) paid by participants and beneficiaries. 
‘‘(9) Any impact on premiums by rebates, fees, and any 
other remuneration paid by drug manufacturers to the plan 
or its administrators or service providers, with respect to 
prescription drugs prescribed to participants or beneficiaries 
in the plan, including— 
‘‘(A) the amounts so paid for each therapeutic class 
of drugs; and 
‘‘(B) the amounts so paid for each of the 25 drugs 
that yielded the highest amount of rebates and other remu-
neration under the plan from drug manufacturers during 
the plan year. 
‘‘(10) Any reduction in premiums and out-of-pocket costs 
associated with rebates, fees, or other remuneration described 
in paragraph (9). 
‘‘(b) REPORT.—Not later than 18 months after the date on 
which the first report is required under subsection (a) and bian-
nually thereafter, the Secretary, acting in coordination with the 
Inspector General of the Department of the Treasury, shall make 
available on the internet website of the Department of the Treasury 
a report on prescription drug reimbursements under group health 
plans, prescription drug pricing trends, and the role of prescription 
drug costs in contributing to premium increases or decreases under 
such plans, aggregated in such a way as no drug or plan specific 
information will be made public. 
‘‘(c) PRIVACY PROTECTIONS.—No confidential or trade secret 
information submitted to the Secretary under subsection (a) shall 
be included in the report under subsection (b).’’. 
(d) CLERICAL AMENDMENTS.—
H. R. 133—1741 
(1) ERISA.—The table of contents in section 1 of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 
1001 et seq.), as amended by section 201, is further amended 
by inserting after the item relating to section 724 the following 
new item: 
‘‘Sec. 725. Reporting on pharmacy benefits and drug costs.’’. 
(2) IRC.—The table of sections for subchapter B of chapter 
100 of the Internal Revenue Code of 1986, as amended by 
section 201, is further amended by adding at the end the 
following new item: 
‘‘Sec. 9825. Reporting on pharmacy benefits and drug costs.’’. 
TITLE III—PUBLIC HEALTH 
PROVISIONS 
Subtitle A—Extenders Provisions 
SEC. 301. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE 
NATIONAL HEALTH SERVICE CORPS, AND TEACHING 
HEALTH CENTERS THAT OPERATE GME PROGRAMS. 
(a) COMMUNITY HEALTH CENTERS.—Section 10503(b)(1)(F) of 
the Patient Protection and Affordable Care Act (42 U.S.C. 254b– 
2(b)(1)(F)) is amended by striking ‘‘, $4,000,000,000 for fiscal year 
2019, $4,000,000,000 for fiscal year 2020, and $865,753,425 for 
the period beginning on October 1, 2020, and ending on December 
18, 2020’’ and inserting ‘‘and $4,000,000,000 for each of fiscal years 
2019 through 2023’’. 
(b) NATIONAL HEALTH SERVICE CORPS.—Section 10503(b)(2)(H) 
of the Patient Protection and Affordable Care Act (42 U.S.C. 254b– 
2(b)(2)(H)) is amended by striking ‘‘ $67,095,890 for the period 
beginning on October 1, 2020, and ending on December 18, 2020’’ 
and inserting ‘‘ $310,000,000 for each of fiscal years 2021 through 
2023’’. 
(c) TEACHING HEALTH CENTERS THAT OPERATE GRADUATE MED-
ICAL EDUCATION PROGRAMS.—Section 340H(g)(1) of the Public 
Health Service Act (42 U.S.C. 256h(g)(1)) is amended— 
(1) by inserting ‘‘and’’ after ‘‘2017,’’; and 
(2) by striking ‘‘fiscal year 2020, and $27,379,452 for the 
period beginning on October 1, 2020, and ending on December 
18, 2020’’ and inserting ‘‘2023’’. 
(d) APPLICATION OF PROVISIONS.—Amounts appropriated pursu-
ant to the amendments made by this section for fiscal years 2021 
through 2023 shall be subject to the requirements contained in 
Public Law 116–94 for funds for programs authorized under sections 
330 through 340 of the Public Health Service Act. 
(e) CONFORMING
AMENDMENTS.—Paragraph (4) of section 
3014(h) of title 18, United States Code, as amended by section 
1201(e) of the Further Continuing Appropriations Act, 2021, and 
Other Extensions Act, is amended by striking ‘‘and section 1201(d) 
of the Further Continuing Appropriations Act, 2021, and Other 
Extensions Act’’ and inserting ‘‘, section 1201(d) of the Further 
Continuing Appropriations Act, 2021, and Other Extensions Act,
H. R. 133—1742 
and section 301(d) of division BB of the Consolidated Appropriations 
Act, 2021.’’. 
SEC. 302. DIABETES PROGRAMS. 
(a) TYPE I.—Section 330B(b)(2)(D) of the Public Health Service 
Act (42 U.S.C. 254c–2(b)(2)(D)) is amended by striking ‘‘2020, and 
$32,465,753 for the period beginning on October 1, 2020, and ending 
on December 18, 2020’’ and inserting ‘‘2023’’. 
(b) INDIANS.—Section 330C(c)(2)(D) of the Public Health Service 
Act (42 U.S.C. 254c–3(c)(2)(D)) is amended by striking ‘‘2020, and 
$32,465,753 for the period beginning on October 1, 2020, and ending 
on December 18, 2020’’ and inserting ‘‘2023’’. 
Subtitle B—Strengthening Public Health 
SEC. 311. IMPROVING AWARENESS OF DISEASE PREVENTION. 
(a) IN GENERAL.—The Public Health Service Act is amended 
by striking section 313 of such Act (42 U.S.C. 245) and inserting 
the following: 
‘‘SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE OF 
VACCINATIONS. 
‘‘(a) IN GENERAL.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in coordina-
tion with other offices and agencies, as appropriate, shall award 
competitive grants or contracts to one or more public or private 
entities to carry out a national, evidence-based campaign to increase 
awareness and knowledge of the safety and effectiveness of vaccines 
for the prevention and control of diseases, combat misinformation 
about vaccines, and disseminate scientific and evidence-based vac-
cine-related information, with the goal of increasing rates of vaccina-
tion across all ages, as applicable, particularly in communities 
with low rates of vaccination, to reduce and eliminate vaccine- 
preventable diseases. 
‘‘(b) CONSULTATION.—In carrying out the campaign under this 
section, the Secretary shall consult with appropriate public health 
and medical experts, including the National Academy of Medicine 
and medical and public health associations and nonprofit organiza-
tions, in the development, implementation, and evaluation of the 
evidence-based public awareness campaign. 
‘‘(c) REQUIREMENTS.—The campaign under this section shall— 
‘‘(1) be a nationwide, evidence-based media and public 
engagement initiative; 
‘‘(2) include the development of resources for communities 
with low rates of vaccination, including culturally and linguis-
tically appropriate resources, as applicable; 
‘‘(3) include the dissemination of vaccine information and 
communication resources to public health departments, health 
care providers, and health care facilities, including such pro-
viders and facilities that provide prenatal and pediatric care; 
‘‘(4) be complementary to, and coordinated with, any other 
Federal, State, local, or Tribal efforts, as appropriate; and 
‘‘(5) assess the effectiveness of communication strategies 
to increase rates of vaccination. 
‘‘(d) ADDITIONAL ACTIVITIES.—The campaign under this section 
may—
H. R. 133—1743 
‘‘(1) include the use of television, radio, the internet, and 
other media and telecommunications technologies; 
‘‘(2) include the use of in-person activities; 
‘‘(3) be focused to address specific needs of communities 
and populations with low rates of vaccination; and 
‘‘(4) include the dissemination of scientific and evidence- 
based vaccine-related information, such as— 
‘‘(A) advancements in evidence-based research related 
to diseases that may be prevented by vaccines and vaccine 
development; 
‘‘(B) information on vaccinations for individuals and 
communities, including individuals for whom vaccines are 
not 
recommended 
by 
the 
Advisory 
Committee 
for 
Immunization Practices, and the effects of low vaccination 
rates within a community on such individuals; 
‘‘(C) information on diseases that may be prevented 
by vaccines; and 
‘‘(D) information on vaccine safety and the systems 
in place to monitor vaccine safety. 
‘‘(e) EVALUATION.—The Secretary shall— 
‘‘(1) establish benchmarks and metrics to quantitatively 
measure and evaluate the awareness campaign under this sec-
tion; 
‘‘(2) conduct qualitative assessments regarding the aware-
ness campaign under this section; and 
‘‘(3) prepare and submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and Committee on 
Energy and Commerce of the House of Representatives an 
evaluation of the awareness campaign under this section. 
‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under 
this section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities 
described in this section. 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 
to be appropriated to carry out this section and subsections (k) 
and (n) of section 317, $15,000,000 for each of fiscal years 2021 
through 2025.’’. 
(b) GRANTS TO ADDRESS VACCINE-PREVENTABLE DISEASES.—Sec-
tion 317 of the Public Health Service Act (42 U.S.C. 247b) is 
amended— 
(1) in subsection (k)(1)— 
(A) in subparagraph (C), by striking ‘‘; and’’ and 
inserting a semicolon; 
(B) in subparagraph (D), by striking the period and 
inserting a semicolon; and 
(C) by adding at the end the following: 
‘‘(E) planning, implementation, and evaluation of activities 
to address vaccine-preventable diseases, including activities 
to— 
‘‘(i) identify communities at high risk of outbreaks 
related to vaccine-preventable diseases, including through 
improved data collection and analysis; 
‘‘(ii) pilot innovative approaches to improve vaccination 
rates in communities and among populations with low rates 
of vaccination;
H. R. 133—1744 
‘‘(iii) reduce barriers to accessing vaccines and evi-
dence-based information about the health effects of vac-
cines; 
‘‘(iv) partner with community organizations and health 
care providers to develop and deliver evidence-based inter-
ventions, including culturally and linguistically appropriate 
interventions, to increase vaccination rates; 
‘‘(v) improve delivery of evidence-based vaccine-related 
information to parents and others; and 
‘‘(vi) improve the ability of State, local, Tribal, and 
territorial public health departments to engage commu-
nities at high risk for outbreaks related to vaccine-prevent-
able diseases, including, as appropriate, with local edu-
cational agencies, as defined in section 8101 of the 
Elementary and Secondary Education Act of 1965; and 
‘‘(F) research related to strategies for improving awareness 
of scientific and evidence-based vaccine-related information, 
including for communities with low rates of vaccination, in 
order to understand barriers to vaccination, improve vaccina-
tion rates, and assess the public health outcomes of such strate-
gies.’’; and 
(2) by adding at the end the following: 
‘‘(n) VACCINATION DATA.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall 
expand and enhance, and, as appropriate, establish and improve, 
programs and conduct activities to collect, monitor, and analyze 
vaccination coverage data to assess levels of protection from vaccine- 
preventable diseases, including by assessing factors contributing 
to underutilization of vaccines and variations of such factors, and 
identifying communities at high risk of outbreaks associated with 
vaccine-preventable diseases.’’. 
(c) SUPPLEMENTAL GRANT FUNDS.—Section 330(d)(1) of the 
Public Health Service Act (42 U.S.C. 254b) is amended— 
(1) in subparagraph (F), by striking ‘‘and’’ at the end; 
(2) in subparagraph (G), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(H) improving access to recommended immuniza-
tions.’’. 
(d) UPDATE OF 2015 NVAC REPORT.—The National Vaccine 
Advisory Committee established under section 2105 of the Public 
Health Service Act (42 U.S.C. 300aa–5) shall, as appropriate, update 
the report entitled, ‘‘Assessing the State of Vaccine Confidence 
in the United States: Recommendations from the National Vaccine 
Advisory Committee’’, approved by the National Vaccine Advisory 
Committee on June 10, 2015, with respect to factors affecting child-
hood vaccination. 
SEC. 312. GUIDE ON EVIDENCE-BASED STRATEGIES FOR PUBLIC 
HEALTH 
DEPARTMENT 
OBESITY 
PREVENTION 
PRO-
GRAMS. 
(a) DEVELOPMENT AND DISSEMINATION OF AN EVIDENCE-BASED 
STRATEGIES GUIDE.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’), acting through the 
Director of the Centers for Disease Control and Prevention, not 
later than 2 years after the date of enactment of this Act, may—
H. R. 133—1745 
(1) develop a guide on evidence-based strategies for State, 
territorial, and local health departments to use to build and 
maintain effective obesity prevention and reduction programs, 
and, in consultation with Indian Tribes, Tribal organizations, 
and urban Indian organizations, a guide on such evidence- 
based strategies with respect to Indian Tribes and Tribal 
organizations for such Indian Tribes and Tribal organizations 
to use for such purpose, both of which guides shall— 
(A) describe an integrated program structure for imple-
menting interventions proven to be effective in preventing 
and reducing the incidence of obesity; and 
(B) recommend— 
(i) optimal resources, including staffing and infra-
structure, for promoting nutrition and obesity preven-
tion and reduction; and 
(ii) strategies for effective obesity prevention pro-
grams for State, territorial, and local health depart-
ments, Indian Tribes, and Tribal organizations, 
including strategies related to— 
(I) the application of evidence-based and evi-
dence-informed practices to prevent and reduce 
obesity rates; 
(II) the development, implementation, and 
evaluation of obesity prevention and reduction 
strategies for specific communities and popu-
lations; 
(III) 
demonstrated 
knowledge 
of 
obesity 
prevention 
practices 
that 
reduce 
associated 
preventable diseases, health conditions, death, and 
health care costs; 
(IV) best practices for the coordination of 
efforts to prevent and reduce obesity and related 
chronic diseases; 
(V) addressing the underlying risk factors and 
social determinants of health that impact obesity 
rates; and 
(VI) interdisciplinary coordination between rel-
evant public health officials specializing in fields 
such as nutrition, physical activity, epidemiology, 
communications, and policy implementation, and 
collaboration 
between 
public 
health 
officials, 
community-based organizations, and others, as 
appropriate; and 
(2) disseminate the guides and current research, evidence- 
based practices, tools, and educational materials related to 
obesity prevention, consistent with the guides, to State, terri-
torial, and local health departments, Indian Tribes, and Tribal 
organizations. 
(b) TECHNICAL ASSISTANCE.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall 
provide technical assistance to State, territorial, and local health 
departments, Indian Tribes, and Tribal organizations to support 
such health departments in implementing the guide developed 
under subsection (a)(1). 
(c) INDIAN TRIBES; TRIBAL ORGANIZATIONS; URBAN INDIAN 
ORGANIZATIONS.—In this section—
H. R. 133—1746 
(1) the terms ‘‘Indian Tribe’’ and ‘‘Tribal organization’’ have 
the meanings given the terms ‘‘Indian tribe’’ and ‘‘tribal 
organization’’, respectively, in section 4 of the Indian Self-Deter-
mination and Education Assistance Act (25 U.S.C. 5304); and 
(2) the term ‘‘urban Indian organization’’ has the meaning 
given such term in section 4 of the Indian Health Care Improve-
ment Act (25 U.S.C. 1603). 
SEC. 313. EXPANDING CAPACITY FOR HEALTH OUTCOMES. 
Title III of the Public Health Service Act is amended by 
inserting after section 330M (42 U.S.C. 254c–19) the following: 
‘‘SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUTCOMES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible entity’ means an 
entity that provides, or supports the provision of, health care 
services in rural areas, frontier areas, health professional short-
age areas, or medically underserved areas, or to medically 
underserved populations or Native Americans, including Indian 
Tribes, Tribal organizations, and urban Indian organizations, 
and which may include entities leading, or capable of leading, 
a technology-enabled collaborative learning and capacity 
building model or engaging in technology-enabled collaborative 
training of participants in such model. 
‘‘(2) HEALTH
PROFESSIONAL
SHORTAGE
AREA.—The term 
‘health professional shortage area’ means a health professional 
shortage area designated under section 332. 
‘‘(3) INDIAN TRIBE.—The terms ‘Indian Tribe’ and ‘Tribal 
organization’ have the meanings given the terms ‘Indian tribe’ 
and ‘tribal organization’ in section 4 of the Indian Self-Deter-
mination and Education Assistance Act. 
‘‘(4) MEDICALLY
UNDERSERVED
POPULATION.—The term 
‘medically underserved population’ has the meaning given the 
term in section 330(b)(3). 
‘‘(5) NATIVE AMERICANS.—The term ‘Native Americans’ has 
the meaning given the term in section 736 and includes Indian 
Tribes and Tribal organizations. 
‘‘(6) TECHNOLOGY-ENABLED COLLABORATIVE LEARNING AND 
CAPACITY
BUILDING
MODEL.—The term ‘technology-enabled 
collaborative learning and capacity building model’ means a 
distance health education model that connects health care 
professionals, and particularly specialists, with multiple other 
health care professionals through simultaneous interactive 
videoconferencing for the purpose of facilitating case-based 
learning, disseminating best practices, and evaluating out-
comes. 
‘‘(7) URBAN INDIAN ORGANIZATION.—The term ‘urban Indian 
organization’ has the meaning given the term in section 4 
of the Indian Health Care Improvement Act. 
‘‘(b) PROGRAM ESTABLISHED.—The Secretary shall, as appro-
priate, award grants to evaluate, develop, and, as appropriate, 
expand the use of technology-enabled collaborative learning and 
capacity building models, to improve retention of health care pro-
viders and increase access to health care services, such as those 
to address chronic diseases and conditions, infectious diseases, 
mental health, substance use disorders, prenatal and maternal 
health, pediatric care, pain management, palliative care, and other 
specialty care in rural areas, frontier areas, health professional
H. R. 133—1747 
shortage areas, or medically underserved areas and for medically 
underserved populations or Native Americans. 
‘‘(c) USE OF FUNDS.— 
‘‘(1) IN GENERAL.—Grants awarded under subsection (b) 
shall be used for— 
‘‘(A) the development and acquisition of instructional 
programming, and the training of health care providers 
and other professionals that provide or assist in the provi-
sion of services through models described in subsection 
(b), such as training on best practices for data collection 
and leading or participating in such technology-enabled 
activities consistent with technology-enabled collaborative 
learning and capacity-building models; 
‘‘(B) information collection and evaluation activities to 
study the impact of such models on patient outcomes and 
health care providers, and to identify best practices for 
the expansion and use of such models; or 
‘‘(C) other activities consistent with achieving the objec-
tives of the grants awarded under this section, as deter-
mined by the Secretary. 
‘‘(2) OTHER USES.—In addition to any of the uses under 
paragraph (1), grants awarded under subsection (b) may be 
used for— 
‘‘(A) equipment to support the use and expansion of 
technology-enabled collaborative learning and capacity 
building models, including for hardware and software that 
enables distance learning, health care provider support, 
and the secure exchange of electronic health information; 
or 
‘‘(B) support for health care providers and other profes-
sionals that provide or assist in the provision of services 
through such models. 
‘‘(d) LENGTH OF GRANTS.—Grants awarded under subsection 
(b) shall be for a period of up to 5 years. 
‘‘(e) GRANT REQUIREMENTS.—The Secretary may require entities 
awarded a grant under this section to collect information on the 
effect of the use of technology-enabled collaborative learning and 
capacity building models, such as on health outcomes, access to 
health care services, quality of care, and provider retention in 
areas and populations described in subsection (b). The Secretary 
may award a grant or contract to assist in the coordination of 
such models, including to assess outcomes associated with the use 
of such models in grants awarded under subsection (b), including 
for the purpose described in subsection (c)(1)(B). 
‘‘(f) APPLICATION.—An eligible entity that seeks to receive a 
grant under subsection (b) shall submit to the Secretary an applica-
tion, at such time, in such manner, and containing such information 
as the Secretary may require. Such application shall include plans 
to assess the effect of technology-enabled collaborative learning 
and capacity building models on patient outcomes and health care 
providers. 
‘‘(g) ACCESS TO BROADBAND.—In administering grants under 
this section, the Secretary may coordinate with other agencies to 
ensure that funding opportunities are available to support access 
to reliable, high-speed internet for grantees. 
‘‘(h) TECHNICAL
ASSISTANCE.—The Secretary shall provide 
(either directly through the Department of Health and Human
H. R. 133—1748 
Services or by contract) technical assistance to eligible entities, 
including recipients of grants under subsection (b), on the develop-
ment, use, and evaluation of technology-enabled collaborative 
learning and capacity building models in order to expand access 
to health care services provided by such entities, including for 
medically underserved areas and to medically underserved popu-
lations or Native Americans. 
‘‘(i) RESEARCH AND EVALUATION.—The Secretary, in consulta-
tion with stakeholders with appropriate expertise in such models, 
shall develop a strategic plan to research and evaluate the evidence 
for such models. The Secretary shall use such plan to inform the 
activities carried out under this section. 
‘‘(j) REPORT BY SECRETARY.—Not later than 4 years after the 
date of enactment of this section, the Secretary shall prepare and 
submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of 
the House of Representatives, and post on the internet website 
of the Department of Health and Human Services, a report 
including, at minimum— 
‘‘(1) a description of any new and continuing grants 
awarded to entities under subsection (b) and the specific pur-
pose and amounts of such grants; 
‘‘(2) an overview of— 
‘‘(A) the evaluations conducted under subsections (b); 
‘‘(B) technical assistance provided under subsection (h); 
and 
‘‘(C) activities conducted by entities awarded grants 
under subsection (b); and 
‘‘(3) a description of any significant findings or develop-
ments related to patient outcomes or health care providers 
and best practices for eligible entities expanding, using, or 
evaluating 
technology-enabled 
collaborative 
learning 
and 
capacity building models, including through the activities 
described in subsection (h). 
‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 
to be appropriated to carry out this section $10,000,000 for each 
of fiscal years 2022 through 2026.’’. 
SEC. 314. PUBLIC HEALTH DATA SYSTEM MODERNIZATION. 
Subtitle C of title XXVIII of the Public Health Service Act 
(42 U.S.C. 300hh–31 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 2823. PUBLIC HEALTH DATA SYSTEM MODERNIZATION. 
‘‘(a) EXPANDING
CDC 
AND
PUBLIC
HEALTH
DEPARTMENT 
CAPABILITIES.— 
‘‘(1) IN
GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall— 
‘‘(A) conduct activities to expand, modernize, improve, 
and sustain applicable public health data systems used 
by the Centers for Disease Control and Prevention, 
including with respect to the interoperability and improve-
ment of such systems (including as it relates to prepared-
ness for, prevention and detection of, and response to public 
health emergencies); and 
‘‘(B) award grants or cooperative agreements to State, 
local, Tribal, or territorial public health departments for
H. R. 133—1749 
the expansion and modernization of public health data 
systems, to assist public health departments and public 
health laboratories in— 
‘‘(i) assessing current data infrastructure capabili-
ties and gaps to— 
‘‘(I) improve and increase consistency in data 
collection, storage, and analysis; and 
‘‘(II) as appropriate, improve dissemination of 
public health-related information; 
‘‘(ii) improving secure public health data collection, 
transmission, exchange, maintenance, and analysis, 
including with respect to demographic data, as appro-
priate; 
‘‘(iii) improving the secure exchange of data 
between the Centers for Disease Control and Preven-
tion, State, local, Tribal, and territorial public health 
departments, public health laboratories, public health 
organizations, and health care providers, including by 
public health officials in multiple jurisdictions within 
such State, as appropriate, and by simplifying and 
supporting reporting by health care providers, as 
applicable, pursuant to State law, including through 
the use of health information technology; 
‘‘(iv) enhancing the interoperability of public health 
data systems (including systems created or accessed 
by public health departments) with health information 
technology, including with health information tech-
nology certified under section 3001(c)(5); 
‘‘(v) supporting and training data systems, data 
science, and informatics personnel; 
‘‘(vi) supporting earlier disease and health condi-
tion detection, such as through near real-time data 
monitoring, to support rapid public health responses; 
‘‘(vii) supporting activities within the applicable 
jurisdiction related to the expansion and modernization 
of electronic case reporting; and 
‘‘(viii) developing and disseminating information 
related to the use and importance of public health 
data. 
‘‘(2) DATA STANDARDS.—In carrying out paragraph (1), the 
Secretary, acting through the Director of the Centers for Dis-
ease Control and Prevention, shall, as appropriate and in con-
sultation with the Office of the National Coordinator for Health 
Information Technology, designate data and technology stand-
ards (including standards for interoperability) for public health 
data systems, with deference given to standards published by 
consensus-based standards development organizations with 
public input and voluntary consensus-based standards bodies. 
‘‘(3) PUBLIC-PRIVATE
PARTNERSHIPS.—The Secretary may 
develop and utilize public-private partnerships for technical 
assistance, training, and related implementation support for 
State, local, Tribal, and territorial public health departments, 
and the Centers for Disease Control and Prevention, on the 
expansion and modernization of electronic case reporting and 
public health data systems, as applicable. 
‘‘(b) REQUIREMENTS.—
H. R. 133—1750 
‘‘(1) HEALTH INFORMATION TECHNOLOGY STANDARDS.—The 
Secretary may not award a grant or cooperative agreement 
under subsection (a)(1)(B) unless the applicant uses or agrees 
to use standards endorsed by the National Coordinator for 
Health Information Technology pursuant to section 3001(c)(1) 
or adopted by the Secretary under section 3004. 
‘‘(2) WAIVER.—The Secretary may waive the requirement 
under paragraph (1) with respect to an applicant if the Sec-
retary determines that the activities under subsection (a)(1)(B) 
cannot otherwise be carried out within the applicable jurisdic-
tion. 
‘‘(3) APPLICATION.—A State, local, Tribal, or territorial 
health department applying for a grant or cooperative agree-
ment under this section shall submit an application to the 
Secretary at such time and in such manner as the Secretary 
may require. Such application shall include information 
describing— 
‘‘(A) the activities that will be supported by the grant 
or cooperative agreement; and 
‘‘(B) how the modernization of the public health data 
systems involved will support or impact the public health 
infrastructure of the health department, including a 
description of remaining gaps, if any, and the actions 
needed to address such gaps. 
‘‘(c) STRATEGY AND IMPLEMENTATION PLAN.—Not later than 180 
days after the date of enactment of this section, the Secretary, 
acting through the Director of the Centers for Disease Control 
and Prevention, shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a coordi-
nated strategy and an accompanying implementation plan that 
identifies and demonstrates the measures the Secretary will utilize 
to— 
‘‘(1) update and improve applicable public health data sys-
tems used by the Centers for Disease Control and Prevention; 
and 
‘‘(2) carry out the activities described in this section to 
support the improvement of State, local, Tribal, and territorial 
public health data systems. 
‘‘(d) CONSULTATION.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall 
consult with State, local, Tribal, and territorial health departments, 
professional medical and public health associations, associations 
representing hospitals or other health care entities, health informa-
tion technology experts, and other appropriate public or private 
entities regarding the plan and grant program to modernize public 
health data systems pursuant to this section. Activities under this 
subsection may include the provision of technical assistance and 
training related to the exchange of information by such public 
health data systems used by relevant health care and public health 
entities at the local, State, Federal, Tribal, and territorial levels, 
and the development and utilization of public-private partnerships 
for implementation support applicable to this section. 
‘‘(e) REPORT TO CONGRESS.—Not later than 1 year after the 
date of enactment of this section, the Secretary shall submit a 
report to the Committee on Health, Education, Labor, and Pensions
H. R. 133—1751 
of the Senate and the Committee on Energy and Commerce of 
the House of Representatives that includes— 
‘‘(1) a description of any barriers to— 
‘‘(A) public health authorities implementing interoper-
able public health data systems and electronic case 
reporting; 
‘‘(B) the exchange of information pursuant to electronic 
case reporting; 
‘‘(C) reporting by health care providers using such 
public health data systems, as appropriate, and pursuant 
to State law; or 
‘‘(D) improving demographic data collection or analysis; 
‘‘(2) an assessment of the potential public health impact 
of implementing electronic case reporting and interoperable 
public health data systems; and 
‘‘(3) a description of the activities carried out pursuant 
to this section. 
‘‘(f) ELECTRONIC CASE REPORTING.—In this section, the term 
‘electronic case reporting’ means the automated identification, 
generation, and bilateral exchange of reports of health events among 
electronic health record or health information technology systems 
and public health authorities. 
‘‘(g) AUTHORIZATION
OF APPROPRIATIONS.—To carry out this 
section, there are authorized to be appropriated $100,000,000 for 
each of fiscal years 2021 through 2025.’’. 
SEC. 315. NATIVE AMERICAN SUICIDE PREVENTION. 
Section 520E(b) of the Public Health Service Act (42 U.S.C. 
290bb–36(b) is amended by inserting after paragraph (3) the fol-
lowing: 
‘‘(4) CONSULTATION.—An entity described in paragraph 
(1)(A) or (1)(B) that applies for a grant or cooperative agreement 
under this section shall agree to consult or confer with entities 
described in paragraph (1)(C) and Native Hawaiian Health 
Care Systems, as applicable, in the applicable State with 
respect to the development and implementation of a statewide 
early intervention strategy.’’. 
SEC. 316. REAUTHORIZATION OF THE YOUNG WOMEN’S BREAST 
HEALTH 
EDUCATION 
AND 
AWARENESS 
REQUIRES 
LEARNING YOUNG ACT OF 2009. 
Section 399NN(h) of the Public Health Service Act (42 U.S.C. 
280m(h)) is amended by striking ‘‘ $4,900,000 for each of fiscal 
years 2015 through 2019’’ and inserting ‘‘ $9,000,000 for each of 
fiscal years 2022 through 2026’’. 
SEC. 317. REAUTHORIZATION OF SCHOOL-BASED HEALTH CENTERS. 
Section 399Z–1(l) of the Public Health Service Act (42 U.S.C. 
280h–5(l)) is amended by striking ‘‘2010 through 2014’’ and inserting 
‘‘2022 through 2026’’. 
Subtitle C—FDA Amendments 
SEC. 321. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER 
EXTENSION. 
Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360ff(b)(5)) is amended—