4386 
‘‘(II) descriptions of the violations 
uncovered during the course of such in-
vestigations. 
‘‘(ii) NONQUANTITATIVE
TREATMENT 
LIMITATIONS.—To the extent that any ex-
ample described in clause (i) involves a 
finding of compliance or noncompliance 
with regard to any requirement for non-
quantitative treatment limitations, the ex-
ample shall provide sufficient detail to fully 
explain such finding, including a full de-
scription of the criteria involved for approv-
ing medical and surgical benefits and the 
criteria involved for approving mental 
health and substance use disorder benefits. 
‘‘(iii) ACCESS TO ADDITIONAL INFOR-
MATION
REGARDING
COMPLIANCE.—In de-
veloping and issuing the compliance pro-
gram guidance document required under 
this paragraph, the Secretaries specified in 
subparagraph (A)— 
‘‘(I) shall enter into interagency 
agreements with the Inspector General 
of the Department of Health and 
Human Services, the Inspector General 
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4387 
of the Department of Labor, and the 
Inspector General of the Department of 
the Treasury to share findings of com-
pliance and noncompliance with this 
section, section 2726 of the Public 
Health Service Act, or section 712 of 
the Employee Retirement Income Secu-
rity Act of 1974, as applicable; and 
‘‘(II) shall seek to enter into an 
agreement with a State to share infor-
mation on findings of compliance and 
noncompliance with this section, sec-
tion 2726 of the Public Health Service 
Act, or section 712 of the Employee Re-
tirement Income Security Act of 1974, 
as applicable. 
‘‘(C) RECOMMENDATIONS.—The compliance 
program guidance document shall include rec-
ommendations to advance compliance with this 
section, section 2726 of the Public Health Service 
Act, or section 712 of the Employee Retirement 
Income Security Act of 1974, as applicable, and 
encourage the development and use of internal 
controls to monitor adherence to applicable stat-
utes, regulations, and program requirements. 
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4388 
Such internal controls may include illustrative 
examples of nonquantitative treatment limita-
tions on mental health and substance use dis-
order benefits, which may fail to comply with 
this section, section 2726 of the Public Health 
Service Act, or section 712 of the Employee Re-
tirement Income Security Act of 1974, as appli-
cable, in relation to nonquantitative treatment 
limitations on medical and surgical benefits. 
‘‘(D) UPDATING THE COMPLIANCE PROGRAM 
GUIDANCE DOCUMENT.—The Secretary, the Sec-
retary of Health and Human Services, and the 
Secretary of Labor, in consultation with the In-
spector General of the Department of Health and 
Human Services, the Inspector General of the 
Department of Labor, and the Inspector General 
of the Department of the Treasury, shall update 
the compliance program guidance document 
every 2 years to include illustrative, de-identified 
examples (that do not disclose any protected 
health information or individually identifiable 
information) of previous findings of compliance 
and noncompliance with this section, section 
2726 of the Public Health Service Act, or section 
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4389 
712 of the Employee Retirement Income Security 
Act of 1974, as applicable. 
‘‘(7) ADDITIONAL GUIDANCE.— 
‘‘(A) IN GENERAL.—The Secretary, the Sec-
retary of Health and Human Services, and the 
Secretary of Labor shall issue guidance to group 
health plans to assist such plans in satisfying 
the requirements of this section, section 2726 of 
the Public Health Service Act, or section 712 of 
the Employee Retirement Income Security Act of 
1974, as applicable. 
‘‘(B) DISCLOSURE.— 
‘‘(i) GUIDANCE FOR PLANS.—The guid-
ance issued under this paragraph shall in-
clude clarifying information and illus-
trative examples of methods that group 
health plans may use for disclosing infor-
mation to ensure compliance with the re-
quirements under this section, section 2726 
of the Public Health Service Act, or section 
712 of the Employee Retirement Income Se-
curity Act of 1974, as applicable, (and any 
regulations promulgated pursuant to such 
sections, as applicable). 
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4390 
‘‘(ii) DOCUMENTS FOR PARTICIPANTS, 
BENEFICIARIES, CONTRACTING
PROVIDERS, 
OR
AUTHORIZED
REPRESENTATIVES.—The 
guidance issued under this paragraph shall 
include clarifying information and illus-
trative examples of methods that group 
health plans may use to provide any partic-
ipant, beneficiary, contracting provider, or 
authorized representative, as applicable, 
with documents containing information 
that the health plans are required to disclose 
to participants, beneficiaries, contracting 
providers, or authorized representatives to 
ensure compliance with this section, section 
2726 of the Public Health Service Act, or 
section 712 of the Employee Retirement In-
come Security Act of 1974, as applicable, 
compliance with any regulation issued pur-
suant to such respective section, or compli-
ance with any other applicable law or regu-
lation. Such guidance shall include infor-
mation that is comparative in nature with 
respect to— 
‘‘(I) 
nonquantitative 
treatment 
limitations for both medical and sur-
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4391 
gical benefits and mental health and 
substance use disorder benefits; 
‘‘(II) the processes, strategies, evi-
dentiary standards, and other factors 
used to apply the limitations described 
in subclause (I); and 
‘‘(III) the application of the limi-
tations described in subclause (I) to en-
sure that such limitations are applied 
in parity with respect to both medical 
and surgical benefits and mental 
health and substance use disorder bene-
fits. 
‘‘(C) NONQUANTITATIVE TREATMENT LIMI-
TATIONS.—The guidance issued under this para-
graph shall include clarifying information and 
illustrative examples of methods, processes, strat-
egies, evidentiary standards, and other factors 
that group health plans may use regarding the 
development and application of nonquantitative 
treatment limitations to ensure compliance with 
this section, section 2726 of the Public Health 
Service Act, or section 712 of the Employee Re-
tirement Income Security Act of 1974, as appli-
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4392 
cable, (and any regulations promulgated pursu-
ant to such respective section), including— 
‘‘(i) examples of methods of deter-
mining appropriate types of nonquantita-
tive treatment limitations with respect to 
both medical and surgical benefits and men-
tal health and substance use disorder bene-
fits, including nonquantitative treatment 
limitations pertaining to— 
‘‘(I) medical management stand-
ards based on medical necessity or ap-
propriateness, or whether a treatment 
is experimental or investigative; 
‘‘(II) limitations with respect to 
prescription drug formulary design; 
and 
‘‘(III) use of fail-first or step ther-
apy protocols; 
‘‘(ii) examples of methods of deter-
mining— 
‘‘(I) network admission standards 
(such as credentialing); and 
‘‘(II) factors used in provider re-
imbursement methodologies (such as 
service type, geographic market, de-
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4393 
mand for services, and provider sup-
ply, practice size, training, experience, 
and licensure) as such factors apply to 
network adequacy; 
‘‘(iii) examples of sources of informa-
tion that may serve as evidentiary stand-
ards for the purposes of making determina-
tions regarding the development and appli-
cation of nonquantitative treatment limita-
tions; 
‘‘(iv) examples of specific factors, and 
the evidentiary standards used to evaluate 
such factors, used by such plans in per-
forming a nonquantitative treatment limi-
tation analysis; 
‘‘(v) examples of how specific evi-
dentiary standards may be used to deter-
mine whether treatments are considered ex-
perimental or investigative; 
‘‘(vi) examples of how specific evi-
dentiary standards may be applied to each 
service category or classification of benefits; 
‘‘(vii) examples of methods of reaching 
appropriate coverage determinations for 
new mental health or substance use disorder 
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4394 
treatments, such as evidence-based early 
intervention programs for individuals with 
a serious mental illness and types of med-
ical management techniques; 
‘‘(viii) examples of methods of reaching 
appropriate coverage determinations for 
which there is an indirect relationship be-
tween the covered mental health or sub-
stance use disorder benefit and a traditional 
covered medical and surgical benefit, such 
as residential treatment or hospitalizations 
involving voluntary or involuntary commit-
ment; and 
‘‘(ix) additional illustrative examples 
of methods, processes, strategies, evidentiary 
standards, and other factors for which the 
Secretary determines that additional guid-
ance is necessary to improve compliance 
with this section, section 2726 of the Public 
Health Service Act, or section 712 of the 
Employee Retirement Income Security Act 
of 1974, as applicable. 
‘‘(D) PUBLIC COMMENT.—Prior to issuing 
any final guidance under this paragraph, the 
Secretary shall provide a public comment period 
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4395 
of not less than 60 days during which any mem-
ber of the public may provide comments on a 
draft of the guidance. 
‘‘(8) COMPLIANCE REQUIREMENTS.— 
‘‘(A) NONQUANTITATIVE TREATMENT LIMI-
TATION (NQTL) REQUIREMENTS.—In the case of a 
group health plan that provides both medical 
and surgical benefits and mental health or sub-
stance 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 anal-
yses of the design and application of NQTLs 
and, beginning 45 days after the date of enact-
ment of the Consolidated Appropriations Act, 
2021, make available to the Secretary, upon re-
quest, the comparative analyses and the fol-
lowing 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 surgical bene-
fits to which each such term applies in each 
respective benefits classification. 
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4396 
‘‘(ii) The factors used to determine that 
the NQTLs will apply to mental health or 
substance use disorder benefits and medical 
or surgical benefits. 
‘‘(iii) The evidentiary standards used 
for the factors identified in clause (ii), when 
applicable, provided that every factor shall 
be defined, and any other source or evidence 
relied upon to design and apply the NQTLs 
to mental health or substance use disorder 
benefits and medical or surgical benefits. 
‘‘(iv) The comparative analyses dem-
onstrating that the processes, strategies, evi-
dentiary standards, and other factors used 
to apply the NQTLs to mental health or 
substance use disorder benefits, as written 
and in operation, are comparable to, and 
are applied no more stringently than, the 
processes, strategies, evidentiary standards, 
and other factors used to apply the NQTLs 
to medical or surgical benefits in the bene-
fits classification. 
‘‘(v) A disclosure of the specific find-
ings and conclusions reached by the group 
health plan, including any results of the 
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4397 
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 anal-
yses described in subparagraph (A) for 
plans that involve potential violations of 
this section or complaints regarding non-
compliance with this section that concern 
NQTLs and any other instances in which 
the Secretary determines appropriate. The 
Secretary shall request not fewer than 20 
such analyses per year. 
‘‘(ii) ADDITIONAL
INFORMATION.—In 
instances in which the Secretary has con-
cluded that the group health plan has not 
submitted sufficient information for the Sec-
retary 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 
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4398 
comparative analyses described in subpara-
graph (A) for compliance with this section. 
Nothing in this paragraph shall require the 
Secretary to conclude that a group health 
plan is in compliance with this section sole-
ly based upon the inspection of the com-
parative analyses described in subpara-
graph (A), as requested under clause (i). 
‘‘(iii) REQUIRED ACTION.— 
‘‘(I) IN
GENERAL.—In instances 
in which the Secretary has reviewed 
the comparative analyses described in 
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 Sec-
retary the actions the plan will 
take to be in compliance with this 
section and provide to the Sec-
retary 
additional 
comparative 
analyses described in subpara-
graph (A) that demonstrate com-
pliance with this section not later 
than 45 days after the initial de-
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4399 
termination by the Secretary that 
the plan is not in compliance; 
and 
‘‘(bb) following the 45-day 
corrective action period under 
item (aa), if the Secretary makes 
a final determination that the 
plan still is not in compliance 
with this section, not later than 7 
days after such determination, 
shall notify all individuals en-
rolled in the plan that the plan 
has been determined to be not in 
compliance with this section. 
‘‘(II) EXEMPTION FROM DISCLO-
SURE.—Documents or communications 
produced in connection with the Sec-
retary’s recommendations to a group 
health plan shall not be subject to dis-
closure pursuant to section 552 of title 
5, United States Code. 
‘‘(iv) REPORT.—Not later than 1 year 
after the date of enactment of this para-
graph, and not later than October 1 of each 
year thereafter, the Secretary shall submit 
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4402 
protected health information or individually 
identifiable information. 
‘‘(ii) GUIDANCE AND REGULATIONS.— 
Not later than 18 months after the date of 
enactment of this paragraph, the Secretary 
shall finalize any draft or interim guidance 
and regulations relating to mental health 
parity under this section. Such draft guid-
ance shall include guidance to clarify the 
process and timeline for current and poten-
tial participants and beneficiaries (and au-
thorized representatives and health care 
providers of such participants and bene-
ficiaries) with respect to plans to file com-
plaints of such plans being in violation of 
this section, including guidance, by plan 
type, on the relevant State, regional, or na-
tional office with which such complaints 
should be filed. 
‘‘(iii) STATE.—The Secretary shall 
share information on findings of compliance 
and noncompliance discovered upon review-
ing the comparative analyses requested 
under subparagraph (B)(i) shall be shared 
with the State where the group health plan 
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4403 
is located, in accordance with paragraph 
(6)(B)(iii)(II).’’. 
(4) MEDICAID AND CHIP COMPLIANCE.— 
(A) MEDICAID MANAGED CARE ORGANIZA-
TIONS.—Section 1932(b)(8) of the Social Secu-
rity 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 Med-
icaid managed care organization (or a prepaid 
inpatient health plan (as defined by the Sec-
retary) or prepaid ambulatory health plan (as 
defined by the Secretary) that offers services to 
enrollees of a Medicaid managed care organiza-
tion) shall be treated as in compliance with such 
requirements if the Medicaid managed care orga-
nization (or prepaid inpatient health plan or 
prepaid ambulatory health plan) is in compli-
ance 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
PACK-
AGES OR BENCHMARK EQUIVALENT COVERAGE.— 
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4404 
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 ‘‘section 2726(a)’’; and 
(ii) 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 benchmark 
benefit package or benchmark equivalent 
coverage described in such sentence shall be 
treated as in compliance with such require-
ments 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 ‘‘section 2726(a)’’; and 
(ii) by adding at the end the following 
new sentence: ‘‘In applying the previous 
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sentence with respect to requirements under 
paragraph (8) of section 2726(a) of the 
Public Health Service Act, a State child 
health plan described in such sentence shall 
be treated as in compliance with such re-
quirements 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 Sec-
retary 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, 
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4406 
a group health plan or health insurance issuer offering 
group or individual health insurance coverage (except for 
a church plan) shall submit to the Secretary, 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 fre-
quently dispensed 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 spend-
ing, and the annual amount spent by the plan or cov-
erage for each such drug. 
‘‘(6) The 50 prescription drugs with the greatest 
increase in plan expenditures over the plan year pre-
ceding the plan year that is the subject of the report, 
and, for each such drug, the change in amounts ex-
pended by the plan or coverage in each such plan 
year. 
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‘‘(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 services; 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 enroll-
ees, as applicable; and 
‘‘(B) paid by enrollees. 
‘‘(9) Any impact on premiums by rebates, fees, 
and any other remuneration paid by drug manufac-
turers to the plan or coverage or its administrators or 
service providers, with respect to prescription drugs 
prescribed to enrollees in the plan or coverage, includ-
ing— 
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4408 
‘‘(A) the amounts so paid for each thera-
peutic class of drugs; and 
‘‘(B) the amounts so paid for each of the 25 
drugs that yielded the highest amount of rebates 
and other remuneration under the plan or cov-
erage from drug manufacturers during the plan 
year. 
‘‘(10) Any reduction in premiums and out-of- 
pocket costs associated with rebates, fees, or other re-
muneration 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 biannually thereafter, the Secretary, acting through the 
Assistant Secretary of Planning and Evaluation and in co-
ordination with the Inspector General of the Department 
of Health and Human Services, 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 pre-
mium increases or decreases under such plans or coverage, 
aggregated in such a way as no drug or plan specific infor-
mation will be made public. 
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4409 
‘‘(c) PRIVACY PROTECTIONS.—No confidential or trade 
secret information submitted to the Secretary under sub-
section (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 fur-
ther 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 Sec-
retary, 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 bene-
ficiaries. 
‘‘(3) Each State in which the plan or coverage 
is offered. 
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‘‘(4) The 50 brand prescription drugs most fre-
quently dispensed 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 spend-
ing, and the annual amount spent by the plan or cov-
erage for each such drug. 
‘‘(6) The 50 prescription drugs with the greatest 
increase in plan expenditures over the plan year pre-
ceding the plan year that is the subject of the report, 
and, for each such drug, the change in amounts ex-
pended 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 services; and 
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‘‘(B) spending on prescription drugs by— 
‘‘(i) the health plan or coverage; and 
‘‘(ii) 
the 
participants 
and 
bene-
ficiaries. 
‘‘(8) The average monthly premium— 
‘‘(A) paid by employers on behalf of partici-
pants 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 manufac-
turers to the plan or coverage or its administrators or 
service providers, with respect to prescription drugs 
prescribed to participants or beneficiaries in the plan 
or coverage, including— 
‘‘(A) the amounts so paid for each thera-
peutic class of drugs; and 
‘‘(B) the amounts so paid for each of the 25 
drugs that yielded the highest amount of rebates 
and other remuneration under the plan or cov-
erage from drug manufacturers during the plan 
year. 
‘‘(10) Any reduction in premiums and out-of- 
pocket costs associated with rebates, fees, or other re-
muneration described in paragraph (9). 
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‘‘(b) REPORT.—Not later than 18 months after the date 
on which the first report is required under subsection (a) 
and biannually thereafter, the Secretary, acting in coordi-
nation 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 reim-
bursements under group health plans (or health insurance 
coverage offered in connection with such a plan), prescrip-
tion 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 sub-
section (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 Sec-
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retary 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 bene-
ficiaries. 
‘‘(3) Each State in which the plan is offered. 
‘‘(4) The 50 brand prescription drugs most fre-
quently dispensed 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 pre-
ceding the plan year that is the subject of the report, 
and, for each such drug, the change in amounts ex-
pended 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; 
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‘‘(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 services; and 
‘‘(B) spending on prescription drugs by— 
‘‘(i) the health plan; and 
‘‘(ii) 
the 
participants 
and 
bene-
ficiaries. 
‘‘(8) The average monthly premium— 
‘‘(A) paid by employers on behalf of partici-
pants 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 manufac-
turers to the plan or its administrators or service pro-
viders, with respect to prescription drugs prescribed 
to participants or beneficiaries in the plan, includ-
ing— 
‘‘(A) the amounts so paid for each thera-
peutic class of drugs; and 
‘‘(B) the amounts so paid for each of the 25 
drugs that yielded the highest amount of rebates 
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and other remuneration 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 re-
muneration 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 biannually thereafter, the Secretary, acting in coordi-
nation 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, prescrip-
tion 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 sub-
section (a) shall be included in the report under subsection 
(b).’’. 
(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 section 
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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 strik-
ing ‘‘, $4,000,000,000 for fiscal year 2019, $4,000,000,000 
for fiscal year 2020, and $865,753,425 for the period begin-
ning 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 strik-
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ing ‘‘ $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
MEDICAL
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 insert-
ing ‘‘2023’’. 
(d) APPLICATION OF PROVISIONS.—Amounts appro-
priated pursuant 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 Appropria-
tions 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 Ap-
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propriations Act, 2021, and Other Extensions Act, and sec-
tion 301(d) of division BB of the Consolidated Appropria-
tions 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 PREVEN-
TION. 
(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 IMPOR-
TANCE OF VACCINATIONS. 
‘‘(a) IN GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention 
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and in coordination with other offices and agencies, as ap-
propriate, shall award competitive grants or contracts to 
one or more public or private entities to carry out a na-
tional, 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 vaccine-related information, with the goal of increas-
ing rates of vaccination across all ages, as applicable, par-
ticularly 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 appro-
priate public health and medical experts, including the Na-
tional Academy of Medicine and medical and public health 
associations and nonprofit organizations, in the develop-
ment, implementation, and evaluation of the evidence-based 
public awareness campaign. 
‘‘(c) REQUIREMENTS.—The campaign under this sec-
tion 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 
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culturally and linguistically appropriate resources, as 
applicable; 
‘‘(3) include the dissemination of vaccine infor-
mation and communication resources to public health 
departments, health care providers, and health care 
facilities, including such providers 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— 
‘‘(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 com-
munities and populations with low rates of vaccina-
tion; and 
‘‘(4) include the dissemination of scientific and 
evidence-based vaccine-related information, such as— 
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‘‘(A) advancements in evidence-based re-
search related to diseases that may be prevented 
by vaccines and vaccine development; 
‘‘(B) information on vaccinations for indi-
viduals 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 quan-
titatively measure and evaluate the awareness cam-
paign under this section; 
‘‘(2) conduct qualitative assessments regarding 
the awareness campaign under this section; and 
‘‘(3) prepare and submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate 
and Committee on Energy and Commerce of the 
House of Representatives an evaluation of the aware-
ness campaign under this section. 
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‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated 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 DIS-
EASES.—Section 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; 
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‘‘(ii) pilot innovative approaches to improve 
vaccination rates in communities and among 
populations with low rates of vaccination; 
‘‘(iii) reduce barriers to accessing vaccines 
and evidence-based information about the health 
effects of vaccines; 
‘‘(iv) partner with community organiza-
tions and health care providers to develop and 
deliver evidence-based interventions, including 
culturally and linguistically appropriate inter-
ventions, to increase vaccination rates; 
‘‘(v) improve delivery of evidence-based vac-
cine-related information to parents and others; 
and 
‘‘(vi) improve the ability of State, local, 
Tribal, and territorial public health departments 
to engage communities at high risk for outbreaks 
related to vaccine-preventable diseases, including, 
as appropriate, with local educational 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-re-
lated information, including for communities with 
low rates of vaccination, in order to understand bar-
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riers to vaccination, improve vaccination rates, and 
assess the public health outcomes of such strategies.’’; 
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 underutiliza-
tion of vaccines and variations of such factors, and identi-
fying 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 im-
munizations.’’. 
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(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: Rec-
ommendations from the National Vaccine Advisory Com-
mittee’’, approved by the National Vaccine Advisory Com-
mittee on June 10, 2015, with respect to factors affecting 
childhood vaccination. 
SEC. 312. GUIDE ON EVIDENCE-BASED STRATEGIES FOR 
PUBLIC HEALTH DEPARTMENT OBESITY PRE-
VENTION PROGRAMS. 
(a) DEVELOPMENT AND DISSEMINATION OF AN EVI-
DENCE-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— 
(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 In-
dian organizations, a guide on such evidence-based 
strategies with respect to Indian Tribes and Tribal 
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organizations for such Indian Tribes and Tribal orga-
nizations to use for such purpose, both of which 
guides shall— 
(A) describe an integrated program struc-
ture for implementing interventions proven to be 
effective in preventing and reducing the inci-
dence of obesity; and 
(B) recommend— 
(i) optimal resources, including staff-
ing and infrastructure, for promoting nutri-
tion and obesity prevention and reduction; 
and 
(ii) strategies for effective obesity pre-
vention programs for State, territorial, and 
local health departments, Indian Tribes, 
and Tribal organizations, including strate-
gies related to— 
(I) the application of evidence- 
based and evidence-informed practices 
to prevent and reduce obesity rates; 
(II) the development, implementa-
tion, and evaluation of obesity preven-
tion and reduction strategies for spe-
cific communities and populations; 
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(III) demonstrated knowledge of 
obesity prevention practices that reduce 
associated preventable diseases, health 
conditions, death, and health care 
costs; 
(IV) best practices for the coordi-
nation 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 coordina-
tion between relevant public health of-
ficials specializing in fields such as 
nutrition, physical activity, epidemi-
ology, communications, and policy im-
plementation, and collaboration be-
tween public health officials, commu-
nity-based organizations, and others, 
as appropriate; and 
(2) disseminate the guides and current research, 
evidence-based practices, tools, and educational mate-
rials related to obesity prevention, consistent with the 
guides, to State, territorial, and local health depart-
ments, Indian Tribes, and Tribal organizations. 
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(b) TECHNICAL ASSISTANCE.—The Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention, shall provide technical assistance to State, ter-
ritorial, 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— 
(1) the terms ‘‘Indian Tribe’’ and ‘‘Tribal orga-
nization’’ have the meanings given the terms ‘‘Indian 
tribe’’ and ‘‘tribal organization’’, respectively, in sec-
tion 4 of the Indian Self-Determination and Edu-
cation 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 In-
dian Health Care Improvement 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 OUT-
COMES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible enti-
ty’ means an entity that provides, or supports the 
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provision of, health care services in rural areas, fron-
tier areas, health professional shortage areas, or medi-
cally underserved areas, or to medically underserved 
populations or Native Americans, including Indian 
Tribes, Tribal organizations, and urban Indian orga-
nizations, 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 partici-
pants 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-Determination and Edu-
cation 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 
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736 and includes Indian Tribes and Tribal organiza-
tions. 
‘‘(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 profes-
sionals, and particularly specialists, with multiple 
other health care professionals through simultaneous 
interactive videoconferencing for the purpose of facili-
tating case-based learning, disseminating best prac-
tices, and evaluating outcomes. 
‘‘(7) URBAN INDIAN ORGANIZATION.—The term 
‘urban Indian organization’ has the meaning given 
the term in section 4 of the Indian Health Care Im-
provement Act. 
‘‘(b) PROGRAM ESTABLISHED.—The Secretary shall, 
as appropriate, award grants to evaluate, develop, and, as 
appropriate, expand the use of technology-enabled collabo-
rative learning and capacity building models, to improve 
retention of health care providers 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 
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in rural areas, frontier areas, health professional shortage 
areas, or medically underserved areas and for medically un-
derserved populations or Native Americans. 
‘‘(c) USE OF FUNDS.— 
‘‘(1) IN GENERAL.—Grants awarded under sub-
section (b) shall be used for— 
‘‘(A) the development and acquisition of in-
structional programming, and the training of 
health care providers and other professionals that 
provide or assist in the provision 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-en-
abled collaborative learning and capacity-build-
ing 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 achiev-
ing the objectives of the grants awarded under 
this section, as determined by the Secretary. 
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‘‘(2) OTHER USES.—In addition to any of the 
uses under paragraph (1), grants awarded under sub-
section (b) may be used for— 
‘‘(A) equipment to support the use and ex-
pansion 
of 
technology-enabled 
collaborative 
learning and capacity building models, includ-
ing for hardware and software that enables dis-
tance learning, health care provider support, and 
the secure exchange of electronic health informa-
tion; or 
‘‘(B) support for health care providers and 
other professionals 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 re-
quire 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 mod-
els, including to assess outcomes associated with the use of 
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such models in grants awarded under subsection (b), includ-
ing for the purpose described in subsection (c)(1)(B). 
‘‘(f) APPLICATION.—An eligible entity that seeks to re-
ceive a grant under subsection (b) shall submit to the Sec-
retary an application, 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 pro-
viders. 
‘‘(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 Services or by contract) technical assistance 
to eligible entities, including recipients of grants under sub-
section (b), on the development, use, and evaluation of tech-
nology-enabled collaborative learning and capacity building 
models in order to expand access to health care services pro-
vided by such entities, including for medically underserved 
areas and to medically underserved populations or Native 
Americans. 
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‘‘(i) RESEARCH AND EVALUATION.—The Secretary, in 
consultation 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, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives, and post on the internet website of the Department 
of Health and Human Services, a report including, at min-
imum— 
‘‘(1) a description of any new and continuing 
grants awarded to entities under subsection (b) and 
the specific purpose and amounts of such grants; 
‘‘(2) an overview of— 
‘‘(A) the evaluations conducted under sub-
sections (b); 
‘‘(B) technical assistance provided under 
subsection (h); and 
‘‘(C) activities conducted by entities award-
ed grants under subsection (b); and 
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‘‘(3) a description of any significant findings or 
developments 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 sub-
section (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 MODERNIZA-
TION. 
‘‘(a) EXPANDING CDC AND PUBLIC HEALTH DEPART-
MENT CAPABILITIES.— 
‘‘(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Director of the Centers for Disease Con-
trol and Prevention, shall— 
‘‘(A) conduct activities to expand, mod-
ernize, improve, and sustain applicable public 
health data systems used by the Centers for Dis-
ease Control and Prevention, including with re-
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spect to the interoperability and improvement of 
such systems (including as it relates to prepared-
ness for, prevention and detection of, and re-
sponse to public health emergencies); and 
‘‘(B) award grants or cooperative agree-
ments to State, local, Tribal, or territorial public 
health departments for the expansion and mod-
ernization of public health data systems, to assist 
public health departments and public health lab-
oratories in— 
‘‘(i) assessing current data infrastruc-
ture capabilities and gaps to— 
‘‘(I) improve and increase consist-
ency in data collection, storage, and 
analysis; and 
‘‘(II) as appropriate, improve dis-
semination of public health-related in-
formation; 
‘‘(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 Con-
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trol and Prevention, State, local, Tribal, 
and territorial public health departments, 
public health laboratories, public health or-
ganizations, and health care providers, in-
cluding by public health officials in mul-
tiple jurisdictions within such State, as ap-
propriate, and by simplifying and sup-
porting reporting by health care providers, 
as applicable, pursuant to State law, in-
cluding through the use of health informa-
tion technology; 
‘‘(iv) enhancing the interoperability of 
public health data systems (including sys-
tems created or accessed by public health de-
partments) with health information tech-
nology, including with health information 
technology 
certified 
under 
section 
3001(c)(5); 
‘‘(v) supporting and training data sys-
tems, data science, and informatics per-
sonnel; 
‘‘(vi) supporting earlier disease and 
health condition detection, such as through 
near real-time data monitoring, to support 
rapid public health responses; 
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‘‘(vii) supporting activities within the 
applicable jurisdiction related to the expan-
sion and modernization of electronic case 
reporting; and 
‘‘(viii) developing and disseminating 
information related to the use and impor-
tance of public health data. 
‘‘(2) DATA STANDARDS.—In carrying out para-
graph (1), the Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, 
shall, as appropriate and in consultation with the Of-
fice of the National Coordinator for Health Informa-
tion 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 de-
velopment organizations with public input and vol-
untary consensus-based standards bodies. 
‘‘(3) PUBLIC-PRIVATE PARTNERSHIPS.—The Sec-
retary may develop and utilize public-private part-
nerships for technical assistance, training, and re-
lated implementation support for State, local, Tribal, 
and territorial public health departments, and the 
Centers for Disease Control and Prevention, on the 
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expansion and modernization of electronic case re-
porting and public health data systems, as applicable. 
‘‘(b) REQUIREMENTS.— 
‘‘(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 In-
formation Technology pursuant to section 3001(c)(1) 
or adopted by the Secretary under section 3004. 
‘‘(2) WAIVER.—The Secretary may waive the re-
quirement under paragraph (1) with respect to an 
applicant if the Secretary determines that the activi-
ties under subsection (a)(1)(B) cannot otherwise be 
carried out within the applicable jurisdiction. 
‘‘(3) APPLICATION.—A State, local, Tribal, or 
territorial health department applying for a grant or 
cooperative agreement under this section shall submit 
an application to the Secretary at such time and in 
such manner as the Secretary may require. Such ap-
plication 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 im-
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pact the public health infrastructure of the health 
department, including a description of remain-
ing gaps, if any, and the actions needed to ad-
dress such gaps. 
‘‘(c) STRATEGY
AND IMPLEMENTATION PLAN.—Not 
later than 180 days after the date of enactment of this sec-
tion, the Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall 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 a coordinated 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 systems used by the Centers for Disease 
Control and Prevention; and 
‘‘(2) carry out the activities described in this sec-
tion to support the improvement of State, local, Trib-
al, and territorial public health data systems. 
‘‘(d) CONSULTATION.—The Secretary, acting through 
the Director of the Centers for Disease Control and Preven-
tion, 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 information technology experts, 
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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, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives that includes— 
‘‘(1) a description of any barriers to— 
‘‘(A) public health authorities implementing 
interoperable 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 appro-
priate, and pursuant to State law; or 
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‘‘(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 authori-
ties. 
‘‘(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 para-
graph (3) the following: 
‘‘(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 
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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 AWARE-
NESS 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 Cos-
metic Act (21 U.S.C. 360ff(b)(5)) is amended— 
(1) by striking ‘‘December 18, 2020’’ each place 
it appears and inserting ‘‘September 30, 2024’’; and 
(2) in subparagraph (B), by striking ‘‘December 
18, 2022’’ and inserting ‘‘September 30, 2026’’. 
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SEC. 322. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
Section 351(k)(2)(A)(iii) of the Public Health Service 
Act (42 U.S.C. 262(k)(2)(A)(iii)) is amended— 
(1) in subclause (I), by striking ‘‘; and’’ and in-
serting a semicolon; 
(2) in subclause (II), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(III) may include information to 
show that the conditions of use pre-
scribed, recommended, or suggested in 
the labeling proposed for the biological 
product have been previously approved 
for the reference product.’’. 
SEC. 323. ORPHAN DRUG CLARIFICATION. 
Section 527(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360cc(c)) is amended by adding at 
the end the following: 
‘‘(3) APPLICABILITY.—This subsection applies to 
any drug designated under section 526 for which an 
application was approved under section 505 of this 
Act or licensed under section 351 of the Public Health 
Service Act after the date of enactment of the FDA 
Reauthorization Act of 2017, regardless of the date on 
which such drug was designated under section 526.’’. 
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SEC. 324. MODERNIZING THE LABELING OF CERTAIN GE-
NERIC DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 503C the following: 
‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 
GENERIC DRUGS. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘covered drug’ means a drug ap-
proved under section 505(c)— 
‘‘(A) for which there are no unexpired pat-
ents included in the list under section 505(j)(7) 
and no unexpired period of exclusivity; 
‘‘(B) for which the approval of the applica-
tion has been withdrawn for reasons other than 
safety or effectiveness; and 
‘‘(C) for which— 
‘‘(i)(I) there is new scientific evidence 
available pertaining to new or existing con-
ditions of use that is not reflected in the ap-
proved labeling; 
‘‘(II) the approved labeling does not re-
flect current legal and regulatory require-
ments for content or format; or 
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‘‘(III) there is a relevant accepted use 
in clinical practice that is not reflected in 
the approved labeling; and 
‘‘(ii) updating the approved labeling 
would benefit the public health. 
‘‘(2) The term ‘period of exclusivity’, with respect 
to a drug approved under section 505(c), means any 
period of exclusivity under clause (ii), (iii), or (iv) of 
section 505(c)(3)(E), clause (ii), (iii), or (iv) of sec-
tion 505(j)(5)(F), or section 505A, 505E, or 527. 
‘‘(3) The term ‘generic version’ means a drug ap-
proved under section 505(j) whose reference listed 
drug is a covered drug. 
‘‘(4) The term ‘relevant accepted use’ means a 
use for a drug in clinical practice that is supported 
by scientific evidence that appears to the Secretary to 
meet the standards for approval under section 505. 
‘‘(5) The term ‘selected drug’ means a covered 
drug for which the Secretary has determined through 
the process under subsection (c) that the labeling 
should be changed. 
‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The Sec-
retary may identify covered drugs for which labeling up-
dates would provide a public health benefit. To assist in 
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identifying covered drugs, the Secretary may do one or both 
of the following: 
‘‘(1) Enter into cooperative agreements or con-
tracts with public or private entities to review the 
available scientific evidence concerning such drugs. 
‘‘(2) Seek public input concerning such drugs, 
including input on whether there is a relevant accept-
ed use in clinical practice that is not reflected in the 
approved labeling of such drugs or whether new sci-
entific evidence is available regarding the conditions 
of use for such drug, by— 
‘‘(A) holding one or more public meetings; 
‘‘(B) opening a public docket for the sub-
mission of public comments; or 
‘‘(C) other means, as the Secretary deter-
mines appropriate. 
‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 
Secretary determines, with respect to a covered drug, that 
the available scientific evidence meets the standards under 
section 505 for adding or modifying information to the la-
beling or providing supplemental information to the label-
ing regarding the use of the covered drug, the Secretary may 
initiate the process under subsection (d). 
‘‘(d) INITIATION OF THE PROCESS OF UPDATING.—If 
the Secretary determines that labeling changes are appro-
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priate for a selected drug pursuant to subsection (c), the 
Secretary shall provide notice to the holders of approved 
applications for a generic version of such drug that— 
‘‘(1) summarizes the findings supporting the de-
termination of the Secretary that the available sci-
entific evidence meets the standards under section 505 
for adding or modifying information or providing 
supplemental information to the labeling of the cov-
ered drug pursuant to subsection (c); 
‘‘(2) provides a clear statement regarding the ad-
ditional, modified, or supplemental information for 
such labeling, according to the determination by the 
Secretary (including, as applicable, modifications to 
add the relevant accepted use to the labeling of the 
drug as an additional indication for the drug); and 
‘‘(3) states whether the statement under para-
graph (2) applies to the selected drug as a class of 
covered drugs or only to a specific drug product. 
‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days of 
receipt of notification provided by the Secretary pursuant 
to subsection (d), the holder of an approved application for 
a generic version of the selected drug shall— 
‘‘(1) agree to change the approved labeling to re-
flect the additional, modified, or supplemental infor-
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mation the Secretary has determined to be appro-
priate; or 
‘‘(2) notify the Secretary that the holder of the 
approved application does not believe that the re-
quested labeling changes are warranted and submit a 
statement detailing the reasons why such changes are 
not warranted. 
‘‘(f) 
REVIEW
OF
APPLICATION
HOLDER’S
RE-
SPONSE.— 
‘‘(1) IN GENERAL.—Upon receipt of the applica-
tion holder’s response, the Secretary shall promptly 
review each statement received under subsection (e)(2) 
and determine which labeling changes pursuant to the 
Secretary’s notice under subsection (d) are appro-
priate, if any. If the Secretary disagrees with the rea-
sons why such labeling changes are not warranted, the 
Secretary shall provide opportunity for discussions 
with the application holders to reach agreement on 
whether the labeling for the covered drug should be 
updated to reflect available scientific evidence, and if 
so, the content of such labeling changes. 
‘‘(2) CHANGES TO LABELING.—After considering 
all responses from the holder of an approved applica-
tion under paragraph (1) or (2) of subsection (e), and 
any discussion under paragraph (1), the Secretary 
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may order such holder to make the labeling changes 
the Secretary determines are appropriate. Such holder 
of an approved application shall— 
‘‘(A) update its paper labeling for the drug 
at the next printing of that labeling; 
‘‘(B) update any electronic labeling for the 
drug within 30 days of such order; and 
‘‘(C) submit the revised labeling through the 
form, ‘Supplement—Changes Being Effected’. 
‘‘(g) VIOLATION.—If the holder of an approved appli-
cation for the generic version of the selected drug does not 
comply with the requirements of subsection (f)(2), such ge-
neric version of the selected drug shall be deemed to be mis-
branded under section 502. 
‘‘(h) LIMITATIONS; GENERIC DRUGS.— 
‘‘(1) IN GENERAL.—With respect to any labeling 
change required under this section, the generic version 
shall be deemed to have the same conditions of use 
and the same labeling as its reference listed drug for 
purposes of clauses (i) and (v) of section 505(j)(2)(A). 
Any labeling change so required shall not have any 
legal effect for the applicant that is different than the 
legal effect that would have resulted if a supplemental 
application had been submitted and approved to con-
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form the labeling of the generic version to a change 
in the labeling of the reference drug. 
‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes to 
labeling made in accordance with this section shall 
not be eligible for an exclusivity period under this 
Act. 
‘‘(3) SELECTION OF DRUGS.—The Secretary shall 
not identify a drug as a covered drug or select a drug 
label for updating under subsection (b) or (c) solely 
based on the availability of new safety information. 
Upon identification of a drug as a covered drug 
under subsection (b), the Secretary may then consider 
the availability of new safety information (as defined 
in section 505–1(b)) in determining whether the drug 
is a selected drug and in determining what labeling 
changes are appropriate. 
‘‘(i) RULES OF CONSTRUCTION.— 
‘‘(1) APPROVAL STANDARDS.—This section shall 
not be construed as altering the applicability of the 
standards for approval of an application under sec-
tion 505. No order shall be issued under this sub-
section unless the scientific evidence supporting the 
changed labeling meets the standards for approval ap-
plicable to any change to labeling under section 505. 
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‘‘(2) REMOVAL
OF
INFORMATION.—Nothing in 
this section shall be construed to give the Secretary 
additional authority to remove approved indications 
for drugs, other than the authority described in this 
section. 
‘‘(3) SECRETARY AUTHORITY.—Nothing in this 
section shall be construed to limit the authority of the 
Secretary to require labeling changes under section 
505(o). 
‘‘(4) MAINTENANCE OF LABELING.—Nothing in 
this section shall be construed to affect the responsi-
bility of the holder of an approved application under 
section 505(j) to maintain its labeling in accordance 
with existing requirements, including subpart B of 
part 201 and sections 314.70 and 314.97 of title 21, 
Code of Federal Regulations (or any successor regula-
tions). 
‘‘(j) REPORTS.—Not later than 4 years after the date 
of the enactment of this section, and every 4 years there-
after, the Secretary shall prepare and submit to the Com-
mittee on Energy and Commerce of the House of Represent-
atives and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report that— 
‘‘(1) describes the actions of the Secretary under 
this section, including— 
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‘‘(A) the number of covered drugs and de-
scription of the types of drugs the Secretary has 
selected for labeling changes and the rationale for 
such recommended changes; and 
‘‘(B) the number of times the Secretary en-
tered into discussions concerning a disagreement 
with an application holder or holders and a 
summary of the decision regarding a labeling 
change, if any; and 
‘‘(2) includes any recommendations of the Sec-
retary for modifying the program under this sec-
tion.’’. 
SEC. 325. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 
(a) IN GENERAL.—Section 351(k) of the Public Health 
Service Act (42 U.S.C. 262(k)) is amended by adding at 
the end the following: 
‘‘(9) PUBLIC LISTING.— 
‘‘(A) IN GENERAL.— 
‘‘(i) INITIAL PUBLICATION.—Not later 
than 180 days after the date of enactment 
of this paragraph, the Secretary shall pub-
lish and make available to the public in a 
searchable, electronic format— 
‘‘(I) a list of each biological prod-
uct, by nonproprietary name (proper 
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name), for which, as of such date of en-
actment, a biologics license under sub-
section (a) or this subsection is in ef-
fect, or that, as of such date of enact-
ment, is deemed to be licensed under 
this 
section 
pursuant 
to 
section 
7002(e)(4) of the Biologics Price Com-
petition and Innovation Act of 2009; 
‘‘(II) the date of licensure of the 
marketing application and the appli-
cation number; and 
‘‘(III) with respect to each biologi-
cal product described in subclause (I), 
the licensure status, and, as available, 
the marketing status. 
‘‘(ii) REVISIONS.—Every 30 days after 
the publication of the first list under clause 
(i), the Secretary shall revise the list to in-
clude each biological product which has been 
licensed under subsection (a) or this sub-
section during the 30-day period or deemed 
licensed under this section pursuant to sec-
tion 7002(e)(4) of the Biologics Price Com-
petition and Innovation Act of 2009. 
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‘‘(iii) 
PATENT
INFORMATION.—Not 
later than 30 days after a list of patents 
under subsection (l)(3)(A), or a supplement 
to such list under subsection (l)(7), has been 
provided by the reference product sponsor to 
the subsection (k) applicant respecting a bi-
ological product included on the list pub-
lished under this subparagraph, the ref-
erence product sponsor shall provide such 
list of patents (or supplement thereto) and 
their corresponding expiry dates to the Sec-
retary, and the Secretary shall, in revisions 
made under clause (ii), include such infor-
mation for such biological product. Within 
30 days of providing any subsequent or 
supplemental list of patents to any subse-
quent subsection (k) applicant under sub-
section (l)(3)(A) or (l)(7), the reference 
product sponsor shall update the informa-
tion provided to the Secretary under this 
clause with any additional patents from 
such subsequent or supplemental list and 
their corresponding expiry dates. 
‘‘(iv) LISTING OF EXCLUSIVITIES.—For 
each biological product included on the list 
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published under this subparagraph, the Sec-
retary shall specify each exclusivity period 
under paragraph (6) or paragraph (7) for 
which the Secretary has determined such bi-
ological product to be eligible and that has 
not concluded. 
‘‘(B) REVOCATION OR SUSPENSION OF LI-
CENSE.—If the license of a biological product is 
determined by the Secretary to have been revoked 
or suspended for safety, purity, or potency rea-
sons, it may not be published in the list under 
subparagraph (A). If such revocation or suspen-
sion occurred after inclusion of such biological 
product in the list published under subparagraph 
(A), the reference product sponsor shall notify the 
Secretary that— 
‘‘(i) the biological product shall be im-
mediately removed from such list for the 
same period as the revocation or suspension; 
and 
‘‘(ii) a notice of the removal shall be 
published in the Federal Register.’’. 
(b) REVIEW AND REPORT ON TYPES OF INFORMATION 
TO BE LISTED.—Not later than 3 years after the date of 
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enactment of this Act, the Secretary of Health and Human 
Services shall— 
(1) solicit public comment regarding the type of 
information, if any, that should be added to or re-
moved from the list required by paragraph (9) of sec-
tion 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), as added by subsection (a); and 
(2) transmit to Congress an evaluation of such 
comments, including any recommendations about the 
types of information that should be added to or re-
moved from the list. 
Subtitle D—Technical Corrections 
SEC. 331. TECHNICAL CORRECTIONS. 
(a) EDUCATION AND TRAINING RELATING TO GERI-
ATRICS.—Section 753(a)(7)(B) of the Public Health Service 
Act (42 U.S.C. 294c(a)(7)(B)) is amended, in the matter 
preceding clause (i), by striking ‘‘Title VII Health Care 
Workforce Reauthorization Act of 2019’’ and inserting 
‘‘Coronavirus Aid, Relief, and Economic Security Act’’. 
(b) NURSING.—Section 851(d)(3) of the Public Health 
Service Act (42 U.S.C. 297t(d)(3)) is amended by striking 
‘‘Title VIII Nursing Reauthorization Act’’ and inserting 
‘‘Coronavirus Aid, Relief, and Economic Security Act’’. 
(c) CITATION.—Section 3404(a)(9) of the Coronavirus 
Aid, Relief, and Economic Security Act (Public Law 116– 
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136) is amended by striking ‘‘section 846A (42 U.S.C. 
247n–1)’’ and inserting ‘‘section 846A (42 U.S.C. 297n– 
1)’’. 
(d) EFFECTIVE DATE.—The amendments made by 
subsections (a), (b), and (c) shall take effect as if included 
in the enactment of the Coronavirus Aid, Relief, and Eco-
nomic Security Act (Public Law 116–136). 
DIVISION CC—HEALTH 
EXTENDERS 
SEC. 1. TABLE OF CONTENTS. 
Sec. 1. Table of contents. 
TITLE I—MEDICARE PROVISIONS 
Subtitle A—Medicare Extenders 
Sec. 101. Extension of the work geographic index floor under the medicare pro-
gram. 
Sec. 102. Extension of funding for quality measure endorsement, input, and selec-
tion. 
Sec. 103. Extension of funding outreach and assistance for low-income programs. 
Sec. 104. Extension of medicare patient IVIG access demonstration project. 
Sec. 105. Extending the independence at home medical practice demonstration 
program under the medicare program. 
Subtitle B—Other Medicare Provisions 
Sec. 111. Improving measurements under the skilled nursing facility value-based 
purchasing program under the Medicare program. 
Sec. 112. Providing the Medicare Payment Advisory Commission and Medicaid 
and CHIP Payment and Access Commission with access to cer-
tain drug payment information, including certain rebate infor-
mation. 
Sec. 113. Moratorium on payment under the Medicare physician fee schedule of 
the add on code for inherently complex evaluation and manage-
ment visits. 
Sec. 114. Temporary freeze of APM payment incentive thresholds. 
Sec. 115. Permitting occupational therapists to conduct the initial assessment 
visit and complete the comprehensive assessment with respect to 
certain rehabilitation services for home health agencies under the 
Medicare program. 
Sec. 116. Centers for Medicare & Medicaid Services provider outreach and report-
ing on cognitive assessment and care plan services. 
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Sec. 117. Continued coverage of certain temporary transitional home infusion 
therapy services. 
Sec. 118. Transitional coverage and retroactive Medicare part D coverage for cer-
tain low-income beneficiaries. 
Sec. 119. Increasing the use of real-time benefit tools to lower beneficiary costs. 
Sec. 120. Beneficiary enrollment simplification. 
Sec. 121. Waiving budget neutrality for oxygen under the Medicare program. 
Sec. 122. Waiving medicare coinsurance for certain colorectal cancer screening 
tests. 
Sec. 123. Expanding access to mental health services furnished through telehealth. 
Sec. 124. Public-private partnership for health care waste, fraud, and abuse de-
tection. 
Sec. 125. Medicare payment for rural emergency hospital services. 
Sec. 126. Distribution of additional residency positions. 
Sec. 127. Promoting Rural Hospital GME Funding Opportunity. 
Sec. 128. Five-year extension of the rural community hospital demonstration pro-
gram. 
Sec. 129. Extension of Frontier Community Health Integration Project Dem-
onstration. 
Sec. 130. Improving rural health clinic payments. 
Sec. 131. Medicare GME treatment of hospitals establishing new medical resi-
dency training programs after hosting medical resident rotators 
for short durations. 
Sec. 132. Medicare payment for certain Federally qualified health center and 
rural health clinic services furnished to hospice patients. 
Sec. 133. Delay to the implementation of the radiation oncology model under the 
Medicare program. 
Sec. 134. Improving access to skilled nursing facility services for hemophilia pa-
tients. 
TITLE II—MEDICAID EXTENDERS AND OTHER POLICIES 
Sec. 201. Eliminating DSH reductions for fiscal years 2021 through 2023. 
Sec. 202. Supplemental payment reporting requirements. 
Sec. 203. Medicaid shortfall and third party payments. 
Sec. 204. Extension of Money Follows the Person Rebalancing Demonstration. 
Sec. 205. Extension of spousal impoverishment protections. 
Sec. 206. Extension of community mental health services demonstration program. 
Sec. 207. Clarifying authority of State Medicaid fraud and abuse control units 
to investigate and prosecute cases of Medicaid patient abuse and 
neglect in any setting. 
Sec. 208. Medicaid coverage for citizens of Freely Associated States. 
Sec. 209. Medicaid coverage of certain medical transportation. 
Sec. 210. Promoting access to life-saving therapies for Medicaid enrollees by en-
suring coverage of routine patient costs for items and services 
furnished in connection with participation in qualifying clinical 
trials. 
TITLE III—HUMAN SERVICES 
Sec. 301. Extension of TANF, child care entitlement to States, and related pro-
grams. 
Sec. 302. Personal responsibility education extension. 
Sec. 303. Sexual risk avoidance education extension. 
Sec. 304. Extension of support for current health professions opportunity grants. 
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Sec. 305. Extension of MaryLee Allen Promoting Safe and Stable Families Pro-
gram and State court support. 
TITLE IV—HEALTH OFFSETS 
Sec. 401. Requiring certain manufacturers to report drug pricing information 
with respect to drugs under the Medicare program. 
Sec. 402. Extended months of coverage of immunosuppressive drugs for kidney 
transplant patients and other renal dialysis provisions. 
Sec. 403. Permitting direct payment to physician assistants under Medicare. 
Sec. 404. Adjusting calculation of hospice cap amount under Medicare. 
Sec. 405. Special rule for determination of ASP in cases of certain noncovered 
self-administered drug products. 
Sec. 406. Medicaid Improvement Fund. 
Sec. 407. Establishing hospice program survey and enforcement procedures under 
the Medicare program. 
Sec. 408. Medicare Improvement Fund. 
TITLE V—MISCELLANEOUS 
Sec. 501. Implementation funding. 
TITLE I—MEDICARE PROVISIONS 
Subtitle A—Medicare Extenders 
SEC. 101. EXTENSION OF THE WORK GEOGRAPHIC INDEX 
FLOOR UNDER THE MEDICARE PROGRAM. 
Section 1848(e)(1)(E) of the Social Security Act (42 
U.S.C. 1395w–4(e)(1)(E)), as amended by section 3801 of 
the CARES Act (Public Law 116–136), section 2201 of the 
Continuing Appropriations Act, 2021 and Other Exten-
sions Act (Public Law 116–159), and section 1101 of the 
Further Continuing Appropriations Act, 2021, and Other 
Extensions Act, is amended by striking ‘‘December 19, 
2020’’ and inserting ‘‘January 1, 2024’’. 
SEC. 102. EXTENSION OF FUNDING FOR QUALITY MEASURE 
ENDORSEMENT, INPUT, AND SELECTION. 
(a) EXTENSION.—Section 1890(d)(2) of the Social Se-
curity Act (42 U.S.C. 1395aaa(d)(2)), as amended by sec-
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tion 1103 of the Further Continuing Appropriations Act, 
2021, and Other Extensions Act, is amended— 
(1) in the first sentence, by striking ‘‘and for the 
period beginning on October 1, 2020, and ending on 
December 18, 2020, the amount equal to the pro rata 
portion of the amount appropriated for such period 
for fiscal year 2020’’ and inserting ‘‘ $26,000,000 for 
fiscal year 2021, $20,000,000 for fiscal year 2022, 
and $20,000,000 for fiscal year 2023’’; and 
(2) in the third sentence, by striking ‘‘and 2020, 
and for the period beginning on October 1, 2020, and 
ending on December 18, 2020’’ and inserting ‘‘2020, 
2021, 2022, and 2023’’. 
(b) ADDITIONAL REPORTING REQUIREMENTS.—Sec-
tion 1890 of the Social Security Act (42 U.S.C. 1395aaa) 
is amended— 
(1) in subsection (e)— 
(A) 
by 
redesignating 
paragraphs 
(1) 
through (6) as subparagraphs (A) through (F), 
respectively; 
(B) by striking ‘‘CONGRESS.—By not later 
than’’ and inserting ‘‘CONGRESS.— 
‘‘(1) IN GENERAL.—By not later than’’; 
(C) in subparagraph (A), as redesignated 
by this paragraph, by striking the last sentence; 
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(D) in subparagraph (D), as so redesig-
nated, by striking ‘‘A description’’ and inserting 
‘‘Subject to paragraph (2)(B), a description’’; 
(E) in subparagraph (E), as so redesig-
nated, by striking ‘‘The amount’’ and inserting 
‘‘Subject to paragraph (2)(B), the amount’’; 
(F) in subparagraph (F), as so redesig-
nated, by striking ‘‘Estimates’’ and inserting 
‘‘Subject to paragraph (2)(B), estimates’’; and 
(G) by adding at the end the following new 
paragraph: 
‘‘(2) ADDITIONAL
REQUIREMENTS
FOR
RE-
PORTS.— 
‘‘(A) ADDRESSING GAO REPORT.—Each of 
the annual reports submitted in 2021 and 2022 
pursuant to paragraph (1) shall also include the 
following: 
‘‘(i) A comprehensive analysis detail-
ing the ways in which the Centers for Medi-
care & Medicaid Services has addressed 
each of the recommendations set forth in the 
report by the Government Accountability 
Office (GAO–19–628) issued on September 
19, 2019, and titled ‘Health Care Quality: 
CMS Could More Effectively Ensure Its 
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Quality Measurement Activities Promote Its 
Objectives’. 
‘‘(ii) A detailed description of— 
‘‘(I) any additional steps that the 
Centers for Medicare & Medicaid Serv-
ices expects to take to address the find-
ings and recommendations set forth in 
such report; and 
‘‘(II) the anticipated timing for 
such steps. 
‘‘(B) ENSURING DETAILED INFORMATION.— 
‘‘(i) IN GENERAL.—In the case of an 
annual report submitted in 2021 or a subse-
quent year pursuant to paragraph (1), the 
information required under— 
‘‘(I) paragraph (1)(D) shall also 
include detailed information on each of 
the activities described in clause (ii); 
‘‘(II) paragraph (1)(E) shall also 
include detailed information on the 
specific amounts obligated or expended 
on each of the activities described in 
clause (ii); and 
‘‘(III) paragraph (1)(F) shall also 
include detailed information on the 
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specific quality measurement activities 
required and future funding needed for 
each of the activities described in 
clause (ii). 
‘‘(ii) ACTIVITIES DESCRIBED.—The ac-
tivities described in this clause are the fol-
lowing: 
‘‘(I) Measure selection activities. 
‘‘(II) Measure development activi-
ties. 
‘‘(III) Public reporting activities. 
‘‘(IV) Education and outreach ac-
tivities.’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(f) ADDITIONAL REPORTING BY THE SECRETARY TO 
CONGRESS.— 
‘‘(1) IN GENERAL.—By not later than September 
30 of each year (beginning with 2021), the Secretary 
shall submit to Congress a report on the amount of 
unobligated balances for appropriations relating to 
quality measurement. Such report shall include de-
tailed plans on how the Secretary expects to expend 
such unobligated balances in the upcoming fiscal 
years. 
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‘‘(2) SEPARATE REPORT.—The annual report re-
quired under paragraph (1) shall be separate from the 
annual report required under subsection (e).’’. 
(c) INPUT
FOR REMOVAL
OF MEASURES.—Section 
1890(b) of the Social Security Act (42 U.S.C. 1395aaa(b)) 
is amended by inserting after paragraph (3) the following 
new paragraph: 
‘‘(4) REMOVAL OF MEASURES.—The entity may 
provide input to the Secretary on quality and effi-
ciency measures described in paragraph (7)(B) that 
could be considered for removal.’’. 
(d) PRIORITIZATION OF MEASURE ENDORSEMENT.— 
Section 1890(b) of the Social Security Act (42 U.S.C. 
1395aaa(b)) is amended by adding at the end the following 
new paragraph: 
‘‘(9) PRIORITIZATION
OF
MEASURE
ENDORSE-
MENT.—The Secretary— 
‘‘(A) during the period beginning on the 
date of the enactment of this paragraph and end-
ing on December 31, 2023, shall prioritize the 
endorsement of measures relating to maternal 
morbidity and mortality by the entity with a 
contract under subsection (a) in connection with 
endorsement of measures described in paragraph 
(2); and 
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‘‘(B) on and after January 1, 2024, may 
prioritize the endorsement of such measures by 
such entity.’’. 
SEC. 103. EXTENSION OF FUNDING OUTREACH AND ASSIST-
ANCE FOR LOW-INCOME PROGRAMS. 
(a) STATE HEALTH INSURANCE PROGRAMS.—Sub-
section (a)(1)(B) of section 119 of the Medicare Improve-
ments for Patients and Providers Act of 2008 (42 U.S.C. 
1395b–3 note), as amended by section 3306 of the Patient 
Protection and Affordable Care Act (Public Law 111–148), 
section 610 of the American Taxpayer Relief Act of 2012 
(Public Law 112–240), section 1110 of the Pathway for 
SGR Reform Act of 2013 (Public Law 113–67), section 110 
of the Protecting Access to Medicare Act of 2014 (Public 
Law 113–93), section 208 of the Medicare Access and CHIP 
Reauthorization Act of 2015 (Public Law 114–10), section 
50207 of division E of the Bipartisan Budget Act of 2018 
(Public Law 115–123), section 1402 of division B of the 
Continuing Appropriations Act, 2020, and Health Extend-
ers Act of 2019 (Public Law 116–59), section 1402 of divi-
sion B of the Further Continuing Appropriations Act, 2020, 
and Further Health Extenders Act of 2019 (Public Law 
116–69), section 103 of division N of the Further Consoli-
dated Appropriations Act, 2020 (Public Law 116–94), sec-
tion 3803 of the CARES Act (Public Law 116–136), section 
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2203 of the Continuing Appropriations Act, 2021 and 
Other Extensions Act (Public Law 116–159), and section 
1102 of the Further Continuing Appropriations Act, 2021, 
and Other Extensions Act, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; 
and 
(2) by striking clause (xi) and inserting the fol-
lowing clauses: 
‘‘(xi) for fiscal year 2021, $15,000,000; 
‘‘(xii) 
for 
fiscal 
year 
2022, 
$15,000,000; and 
‘‘(xiii) 
for 
fiscal 
year 
2023, 
$15,000,000.’’. 
(b) AREA AGENCIES ON AGING.—Subsection (b)(1)(B) 
of such section 119, as so amended, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; 
and 
(2) by striking clause (xi) and inserting the fol-
lowing clauses: 
‘‘(xi) for fiscal year 2021, $15,000,000; 
‘‘(xii) 
for 
fiscal 
year 
2022, 
$15,000,000; and 
‘‘(xiii) 
for 
fiscal 
year 
2023, 
$15,000,000.’’. 
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(c) AGING AND DISABILITY RESOURCE CENTERS.— 
Subsection (c)(1)(B) of such section 119, as so amended, 
is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; 
(2) by striking clause (xi) and inserting the fol-
lowing clauses: 
‘‘(xi) for fiscal year 2021, $5,000,000; 
‘‘(xii) for fiscal year 2022, $5,000,000; 
and 
‘‘(xiii) 
for 
fiscal 
year 
2023, 
$5,000,000,’’. 
(d) CONTRACT WITH THE NATIONAL CENTER FOR 
BENEFITS
AND
OUTREACH
ENROLLMENT.—Subsection 
(d)(2) of such section 119, as so amended, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; 
(2) by striking clause (xi) and inserting the fol-
lowing clauses: 
‘‘(xi) for fiscal year 2021, $15,000,000; 
‘‘(xii) 
for 
fiscal 
year 
2022, 
$15,000,000; and 
‘‘(xiii) 
for 
fiscal 
year 
2023, 
$15,000,000.’’. 
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4469 
SEC. 104. EXTENSION OF MEDICARE PATIENT IVIG ACCESS 
DEMONSTRATION PROJECT. 
(a) EXTENSION OF DEMONSTRATION PROJECT.—Sec-
tion 101(b) of the Medicare IVIG Access and Strengthening 
Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C. 
13951 note) is amended— 
(1) by striking paragraph (1) and inserting the 
following: 
‘‘(1) DURATION.—Beginning not later than one 
year after the date of enactment of this Act, the Sec-
retary shall conduct the demonstration project for a 
period of 3 years and, subject to the availability of 
funds under subsection (g), the period beginning on 
October 1, 2017, and ending on December 31, 2023.’’; 
and 
(2) in paragraph (2)— 
(A) by amending the first sentence to read 
as follows: ‘‘The Secretary shall enroll for par-
ticipation in the demonstration project for the 
period beginning on October 1, 2014, and ending 
on September 30, 2020, not more than 4,000 
Medicare beneficiaries who have been diagnosed 
with primary immunodeficiency disease and for 
the period beginning on October 1, 2014, and 
ending on December 31, 2023, not more than 
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4470 
6,500 Medicare beneficiaries who have been so 
diagnosed.’’; and 
(B) by striking ‘‘December 31, 2020’’ and 
inserting ‘‘December 31, 2023’’. 
(b) UPDATED EVALUATION
AND REPORT.—Section 
101(f) is amended— 
(1) by redesignating paragraph (2) as para-
graph (3); and 
(2) by inserting after paragraph (1) the fol-
lowing new paragraph: 
‘‘(2) UPDATED EVALUATION AND REPORT.—Not 
later than 2 years after the date of the enactment of 
Consolidated Appropriations Act, 2021, the Secretary 
shall submit to Congress an updated report that con-
tains the following: 
‘‘(A) The total number of beneficiaries en-
rolled in the demonstration project during the 
updated report period. 
‘‘(B) The total number of claims submitted 
for services during the updated report period, 
disaggregated by month. 
‘‘(C) An analysis of the impact of the dem-
onstration on beneficiary access to the in-home 
administration of intravenous immune globin, 
including the impact on beneficiary health. 
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‘‘(D) An analysis of the impact of in-home 
administration of intravenous immune globin on 
overall costs to Medicare, including the cost dif-
ferential between in-home administration of in-
travenous immune globin and administration of 
intravenous immune globin in a healthcare facil-
ity. 
‘‘(E) To the extent practicable, a survey of 
providers and enrolled beneficiaries that partici-
pated in the demonstration project that identifies 
barriers to accessing services, including reim-
bursement for items and services. 
‘‘(F) Recommendations to Congress on the 
appropriateness of establishing a permanent 
bundled services payment for the in-home ad-
ministration of intravenous immune globin for 
Medicare beneficiaries.’’. 
(c) DEFINITION OF UPDATED REPORT PERIOD.—Sec-
tion 101(h) is amended by adding at the end the following 
new paragraph: 
‘‘(4) UPDATED REPORT PERIOD.—The term ‘up-
dated report period’ means the period beginning on 
October 1, 2014, and ending on September 30, 2020.’’. 
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SEC. 105. EXTENDING THE INDEPENDENCE AT HOME MED-
ICAL PRACTICE DEMONSTRATION PROGRAM 
UNDER THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1866E of the Social Secu-
rity Act (42 U.S.C. 1395cc–5) is amended— 
(1) in subsection (e)— 
(A) in paragraph (1), by striking ‘‘7-year’’ 
and inserting ‘‘10-year’’; and 
(B) in paragraph (5)— 
(i) in the first sentence, by striking 
‘‘15,000’’ and inserting ‘‘20,000’’; 
(ii) in the second sentence, by striking 
‘‘sixth and seventh’’ and inserting ‘‘sixth 
through tenth’’; and 
(iii) by adding at the end the following 
new sentence: ‘‘An applicable beneficiary 
that participates in the demonstration pro-
gram by reason of the increase from 15,000 
to 20,000 in the first sentence of this para-
graph pursuant to the amendment made by 
section 105 of division CC of the Consoli-
dated Appropriations Act, 2021 shall be 
considered in the spending target estimates 
under paragraph (1) of subsection (c) and 
the incentive payment calculations under 
paragraph (2) of such subsection for the 
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eighth through tenth years of such pro-
gram.’’; and 
(2) in subsection (h), by inserting ‘‘and 
$9,000,000 for fiscal year 2021’’ after ‘‘2015’’. 
(b) EFFECTIVE DATE.—The amendments made by sub-
section (a) shall take effect as if included in the enactment 
of Public Law 111–148. 
Subtitle B—Other Medicare 
Provisions 
SEC. 
111. 
IMPROVING 
MEASUREMENTS 
UNDER 
THE 
SKILLED NURSING FACILITY VALUE-BASED 
PURCHASING PROGRAM UNDER THE MEDI-
CARE PROGRAM. 
(a) IN GENERAL.—Section 1888(h) of the Social Secu-
rity Act (42 U.S.C. 1395yy(h)) is amended— 
(1) in paragraph (1), by adding at the end the 
following new subparagraph: 
‘‘(C) EXCLUSIONS.—With respect to pay-
ments for services furnished on or after October 
1, 2022, this subsection shall not apply to a fa-
cility for which there are not a minimum num-
ber (as determined by the Secretary) of— 
‘‘(i) cases for the measures that apply 
to the facility for the performance period for 
the applicable fiscal year; or 
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‘‘(ii) measures that apply to the facil-
ity for the performance period for the appli-
cable fiscal year.’’; 
(2) in paragraph (2)(A)— 
(A) by striking ‘‘The Secretary shall apply’’ 
and inserting ‘‘The Secretary— 
‘‘(i) shall apply’’; 
(B) by striking the period at the end and 
inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(ii) may, with respect to payments 
for services furnished on or after October 1, 
2023, apply additional measures deter-
mined appropriate by the Secretary, which 
may include measures of functional status, 
patient safety, care coordination, or patient 
experience. 
Subject to the succeeding sentence, in the case 
that the Secretary applies additional measures 
under clause (ii), the Secretary shall consider 
and apply, as appropriate, quality measures 
specified under section 1899B(c)(1). In no case 
may the Secretary apply more than 10 measures 
under this subparagraph.’’; 
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‘‘or a rural emergency hospital (as defined in 
subsection (kkk)(2))’’ before the period at the end; 
and 
(B) by adding at the end the following sub-
section: 
‘‘Rural Emergency Hospital Services; Rural Emergency 
Hospital 
‘‘(kkk)(1) RURAL EMERGENCY HOSPITAL SERVICES.— 
‘‘(A) IN GENERAL.—The term ‘rural emergency 
hospital services ’ means the following services fur-
nished by a rural emergency hospital (as defined in 
paragraph (2)) that do not exceed an annual per pa-
tient average of 24 hours in such rural emergency 
hospital: 
‘‘(i) Emergency department services and ob-
servation care. 
‘‘(ii) At the election of the rural emergency 
hospital, with respect to services furnished on an 
outpatient basis, other medical and health serv-
ices as specified by the Secretary through rule-
making. 
‘‘(B) STAFFED EMERGENCY DEPARTMENT.—For 
purposes of subparagraph (A)(i), an emergency de-
partment of a rural emergency hospital shall be con-
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