H. R. 133—1805 
assistance provided to an individual described in section 431(b)(8) 
of the Personal Responsibility and Work Opportunity Reconciliation 
Act of 1996 (8 U.S.C. 1641(b)(8)) shall not be taken into account 
for purposes of applying payment limits under subsections (f) and 
(g).’’. 
(e) EFFECTIVE DATE.—The amendments made by this section 
shall apply to benefits for items and services furnished on or after 
the date of the enactment of this Act. 
SEC. 209. MEDICAID COVERAGE OF CERTAIN MEDICAL TRANSPOR-
TATION. 
(a) CONTINUING REQUIREMENT OF MEDICAID COVERAGE OF NEC-
ESSARY TRANSPORTATION.— 
(1) REQUIREMENT.—Section 1902(a)(4) of the Social Security 
Act (42 U.S.C. 1396a(a)(4)) is amended— 
(A) by striking ‘‘and including provision for utilization’’ 
and inserting ‘‘including provision for utilization’’; and 
(B) by inserting after ‘‘supervision of administration 
of the plan’’ the following: ‘‘, and, subject to section 1903(i), 
including a specification that the single State agency 
described in paragraph (5) will ensure necessary transpor-
tation for beneficiaries under the State plan to and from 
providers and a description of the methods that such agency 
will use to ensure such transportation’’. 
(2) APPLICATION
WITH
RESPECT
TO
BENCHMARK
BENEFIT 
PACKAGES
AND
BENCHMARK
EQUIVALENT
COVERAGE.—Section 
1937(a)(1) of the Social Security Act (42 U.S.C. 1396u–7(a)(1)) 
is amended— 
(A) in subparagraph (A), by striking ‘‘subsection (E)’’ 
and inserting ‘‘subparagraphs (E) and (F)’’; and 
(B) by adding at the end the following new subpara-
graph: 
‘‘(F) NECESSARY
TRANSPORTATION.—Notwithstanding 
the preceding provisions of this paragraph, a State may 
not provide medical assistance through the enrollment of 
an individual with benchmark coverage or benchmark 
equivalent coverage described in subparagraph (A)(i) 
unless, subject to section 1903(i)(9) and in accordance with 
section 1902(a)(4), the benchmark benefit package or bench-
mark equivalent coverage (or the State)— 
‘‘(i) ensures necessary transportation for individ-
uals enrolled under such package or coverage to and 
from providers; and 
‘‘(ii) provides a description of the methods that 
will be used to ensure such transportation.’’. 
(3) LIMITATION
ON
FEDERAL
FINANCIAL
PARTICIPATION.— 
Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) 
is amended by inserting after paragraph (8) the following new 
paragraph: 
‘‘(9) with respect to any amount expended for non-emer-
gency transportation authorized under section 1902(a)(4), 
unless the State plan provides for the methods and procedures 
required under section 1902(a)(30)(A); or’’. 
(4) EFFECTIVE DATE.—The amendments made by this sub-
section shall take effect on the date of the enactment of this 
Act and shall apply to transportation furnished on or after 
such date.
H. R. 133—1806 
(b) MEDICAID PROGRAM INTEGRITY MEASURES RELATED TO COV-
ERAGE OF NONEMERGENCY MEDICAL TRANSPORTATION.— 
(1) GAO STUDY.—Not later than two years after the date 
of the enactment of this Act, the Comptroller General of the 
United States shall conduct a study, and submit to Congress, 
a report on coverage under the Medicaid program under title 
XIX of the Social Security Act of nonemergency transportation 
to services. Such study shall take into account the 2009 report 
of the Office of the Inspector General of the Department of 
Health and Human Services, titled ‘‘Fraud and Abuse Safe-
guards for State Medicaid Nonemergency Medical Transpor-
tation Services’’ (OEI–06–07–00320). Such report shall include 
the following: 
(A) An examination of the 50 States and the District 
of Columbia to identify safeguards to prevent and detect 
fraud and abuse with respect to coverage under the Med-
icaid program of nonemergency transportation to covered 
services. 
(B) An examination of transportation brokers to iden-
tify the range of safeguards against such fraud and abuse 
to prevent improper payments for such transportation. 
(C) Identification of the numbers, types, and outcomes 
of instances of fraud and abuse, with respect to coverage 
under the Medicaid program of such transportation, that 
State Medicaid Fraud Control Units have investigated in 
recent years. 
(D) Identification of commonalities or trends in pro-
gram integrity, with respect to such coverage, to inform 
risk management strategies of States and the Centers for 
Medicare & Medicaid Services. 
(2) STAKEHOLDER MEETINGS.— 
(A) IN GENERAL.—Not later than 18 months after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, through the Centers for Medicare 
& Medicaid Services, shall convene a series of meetings 
to obtain input from appropriate stakeholders to facilitate 
discussion and shared learning about the leading practices 
for improving Medicaid program integrity, with respect 
to coverage of nonemergency transportation to medically 
necessary services. 
(B) TOPICS.—The meetings convened under subpara-
graph (A) shall— 
(i) focus on ongoing challenges to Medicaid pro-
gram integrity as well as leading practices to address 
such challenges; and 
(ii) address specific challenges raised by stake-
holders involved in coverage under the Medicaid pro-
gram of nonemergency transportation to covered serv-
ices, including unique considerations for specific groups 
of Medicaid beneficiaries meriting particular attention, 
such as American Indians and tribal land issues or 
accommodations for individuals with disabilities. 
(C) 
STAKEHOLDERS.—Stakeholders 
described 
in 
subparagraph (A) shall include individuals from State Med-
icaid programs, brokers for nonemergency transportation 
to medically necessary services that meet the criteria 
described in section 1902(a)(70)(B) of the Social Security
H. R. 133—1807 
Act (42 U.S.C. 1396a(a)(70)(B)), providers (including 
transportation network companies), Medicaid patient advo-
cates, and such other individuals specified by the Secretary. 
(3) GUIDANCE REVIEW.—Not later than 24 months after 
the date of the enactment of this Act, the Secretary of Health 
and Human Services, through the Centers for Medicare & 
Medicaid Services, shall assess guidance issued to States by 
the Centers for Medicare & Medicaid Services relating to Fed-
eral requirements for nonemergency transportation to medically 
necessary services under the Medicaid program under title 
XIX of the Social Security Act and update such guidance as 
necessary to ensure States have appropriate and current guid-
ance in designing and administering coverage under the Med-
icaid program of nonemergency transportation to medically nec-
essary services. 
(4) NEMT TRANSPORTATION PROVIDER AND DRIVER REQUIRE-
MENTS.— 
(A) STATE PLAN REQUIREMENT.—Section 1902(a) of the 
Social Security Act (42 U.S.C. 1396a(a)) is amended— 
(i) by striking ‘‘and’’ at the end of paragraph (85); 
(ii) by striking the period at the end of paragraph 
(86) and inserting ‘‘; and’’; and 
(iii) by inserting after paragraph (86) the following 
new paragraph: 
‘‘(87) provide for a mechanism, which may include attesta-
tion, that ensures that, with respect to any provider (including 
a transportation network company) or individual driver of non-
emergency transportation to medically necessary services 
receiving payments under such plan (but excluding any public 
transit authority), at a minimum— 
‘‘(A) each such provider and individual driver is not 
excluded from participation in any Federal health care 
program (as defined in section 1128B(f)) and is not listed 
on the exclusion list of the Inspector General of the Depart-
ment of Health and Human Services; 
‘‘(B) each such individual driver has a valid driver’s 
license; 
‘‘(C) each such provider has in place a process to 
address any violation of a State drug law; and 
‘‘(D) each such provider has in place a process to dis-
close to the State Medicaid program the driving history, 
including any traffic violations, of each such individual 
driver employed by such provider, including any traffic 
violations.’’. 
(B) EFFECTIVE DATE.— 
(i) IN GENERAL.—Except as provided in clause (ii), 
the amendments made by subparagraph (A) shall take 
effect on the date of the enactment of this Act and 
shall apply to services furnished on or after the date 
that is one year after the date of the enactment of 
this Act. 
(ii) EXCEPTION.—In the case of a State plan under 
title XIX of the Social Security Act (42 U.S.C. 1396 
et seq.), or waiver of such plan, that the Secretary 
of Health and Human Services determines requires 
State legislation in order for the respective plan to 
meet any requirement imposed by amendments made
H. R. 133—1808 
by this section, the respective plan shall not be 
regarded as failing to comply with the requirements 
of such title solely on the basis of its failure to meet 
such an additional requirement before the first day 
of the first calendar quarter beginning after the close 
of the first regular session of the State legislature 
that begins after the date of the enactment of this 
Act. For purposes of the previous sentence, in the 
case of a State that has a 2-year legislative session, 
each year of the session shall be considered to be 
a separate regular session of the State legislature. 
(5) ANALYSIS OF T–MSIS DATA.—Not later than one year 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services, through the Centers for Medi-
care & Medicaid Services, shall analyze, and submit to Congress 
a report on, the nation-wide data set under the Transformed 
Medicaid Statistical Information System to identify rec-
ommendations relating to coverage under the Medicaid program 
under title XIX of the Social Security Act of nonemergency 
transportation to medically necessary services. 
(c) CONSULTATION
RELATING
TO
NONEMERGENCY
MEDICAL 
TRANSPORTATION.—In the case of a State that exercises the option 
described in section 1902(a)(70) of the Social Security Act (42 U.S.C. 
1396a(a)(7)), in establishing a non-emergency medical transpor-
tation brokerage program under such section, a State Medicaid 
agency may consult relevant stakeholders, including stakeholders 
representing patients, medical providers, Medicaid managed care 
organizations, brokers for non-emergency medical transportation, 
and transportation providers (including public transportation pro-
viders). 
SEC. 210. PROMOTING ACCESS TO LIFE-SAVING THERAPIES FOR MED-
ICAID ENROLLEES BY ENSURING COVERAGE OF ROU-
TINE PATIENT COSTS FOR ITEMS AND SERVICES FUR-
NISHED IN CONNECTION WITH PARTICIPATION IN QUALI-
FYING CLINICAL TRIALS. 
(a) IN GENERAL.—Section 1905 of the Social Security Act (42 
U.S.C. 1396d) is amended— 
(1) in subsection (a)— 
(A) in paragraph (29), by striking ‘‘and’’ at the end; 
(B) by redesignating paragraph (30) as paragraph (31); 
and 
(C) by inserting after paragraph (29) the following 
new paragraph: 
‘‘(30) subject to subsection (gg), routine patient costs for 
items and services furnished in connection with participation 
in a qualifying clinical trial (as defined in such subsection); 
and’’; and 
(2) by adding at the end the following new subsection: 
‘‘(gg)(1) ROUTINE PATIENT COSTS.—For purposes of subsection 
(a)(30), with respect to a State and an individual enrolled under 
the State plan (or a waiver of such plan) who participates in 
a qualifying clinical trial, routine patient costs— 
‘‘(A) include any item or service provided to the individual 
under the qualifying clinical trial, including—
H. R. 133—1809 
‘‘(i) any item or service provided to prevent, diagnose, 
monitor, or treat complications resulting from such partici-
pation, to the extent that the provision of such an item 
or service to the individual outside the course of such 
participation would otherwise be covered under the State 
plan or waiver; and 
‘‘(ii) any item or service required solely for the provision 
of the investigational item or service that is the subject 
of such trial, including the administration of such investiga-
tional item or service; and 
‘‘(B) does not include— 
‘‘(i) an item or service that is the investigational item 
or service that is— 
‘‘(I) the subject of the qualifying clinical trial; and 
‘‘(II) not otherwise covered outside of the clinical 
trial under the State plan or waiver; or 
‘‘(ii) an item or service that is— 
‘‘(I) provided to the individual solely to satisfy 
data collection and analysis needs for the qualifying 
clinical trial and is not used in the direct clinical 
management of the individual; and 
‘‘(II) not otherwise covered under the State plan 
or waiver. 
‘‘(2) QUALIFYING CLINICAL TRIAL DEFINED.— 
‘‘(A) IN
GENERAL.—For purposes of this subsection and 
subsection (a)(30), the term ‘qualifying clinical trial’ means 
a clinical trial (in any clinical phase of development) that 
is conducted in relation to the prevention, detection, or treat-
ment of any serious or life-threatening disease or condition 
and is described in any of the following clauses: 
‘‘(i) The study or investigation is approved, conducted, 
or supported (which may include funding through in-kind 
contributions) by one or more of the following: 
‘‘(I) The National Institutes of Health. 
‘‘(II) The Centers for Disease Control and Preven-
tion. 
‘‘(III) The Agency for Healthcare Research and 
Quality. 
‘‘(IV) The Centers for Medicare & Medicaid Serv-
ices. 
‘‘(V) A cooperative group or center of any of the 
entities described in subclauses (I) through (IV) or 
the Department of Defense or the Department of Vet-
erans Affairs. 
‘‘(VI) A qualified non-governmental research entity 
identified in the guidelines issued by the National 
Institutes of Health for center support grants. 
‘‘(VII) Any of the following if the conditions 
described in subparagraph (B) are met: 
‘‘(aa) The Department of Veterans Affairs. 
‘‘(bb) The Department of Defense. 
‘‘(cc) The Department of Energy. 
‘‘(ii) The clinical trial is conducted pursuant to an 
investigational new drug exemption under section 505(i) 
of the Federal Food, Drug, and Cosmetic Act or an exemp-
tion for a biological product undergoing investigation under 
section 351(a)(3) of the Public Health Service Act.
H. R. 133—1810 
‘‘(iii) The clinical trial is a drug trial that is exempt 
from being required to have an exemption described in 
clause (ii). 
‘‘(B) 
CONDITIONS.—For 
purposes 
of 
subparagraph 
(A)(i)(VII), the conditions described in this subparagraph, with 
respect to a clinical trial approved or funded by an entity 
described in such subparagraph (A)(i)(VII), are that the clinical 
trial has been reviewed and approved through a system of 
peer review that the Secretary determines— 
‘‘(i) to be comparable to the system of peer review 
of studies and investigations used by the National 
Institutes of Health; and 
‘‘(ii) assures unbiased review of the highest scientific 
standards by qualified individuals with no interest in the 
outcome of the review. 
‘‘(3) COVERAGE DETERMINATION REQUIREMENTS.—A determina-
tion with respect to coverage under subsection (a)(30) for an indi-
vidual participating in a qualifying clinical trial— 
‘‘(A) shall be expedited and completed within 72 hours; 
‘‘(B) shall be made without limitation on the geographic 
location or network affiliation of the health care provider 
treating such individual or the principal investigator of the 
qualifying clinical trial; 
‘‘(C) shall be based on attestation regarding the appro-
priateness of the qualifying clinical trial by the health care 
provider and principal investigator described in subparagraph 
(B), which shall be made using a streamlined, uniform form 
developed for State use by the Secretary and that includes 
the option to reference information regarding the qualifying 
clinical trial that is publicly available on a website maintained 
by the Secretary, such as clinicaltrials.gov (or a successor 
website); and 
‘‘(D) shall not require submission of the protocols of the 
qualifying clinical trial, or any other documentation that may 
be proprietary or determined by the Secretary to be burdensome 
to provide.’’. 
(b) REQUIRING MANDATORY COVERAGE UNDER STATE PLAN.— 
Section 1902(a)(10)(A) of such Act is amended, in the matter pre-
ceding clause (i), by striking ‘‘and (29)’’ and inserting ‘‘(29), and 
(30)’’. 
(c) INCLUSION IN BENCHMARK COVERAGE.—Section 1937(b)(5) 
of such Act is amended by inserting before the period at the end 
the following: ‘‘, and beginning January 1, 2022, coverage of routine 
patient costs for items and services furnished in connection with 
participation in a qualifying clinical trial (as defined in section 
1905(gg))’’. 
(d) EXEMPTION OF ADDITIONAL EXPENDITURES FROM PAYMENT 
LIMITS FOR TERRITORIES.—Section 1108(g)(4) of the Social Security 
Act (42 U.S.C. 1308(g)(4)) is amended— 
(1) by striking ‘‘With respect to’’ and inserting the following: 
‘‘(A) IN GENERAL.—With respect to’’; and 
(2) by adding at the end the following new subparagraph: 
‘‘(B) ADDITIONAL EXEMPTION.—Payments under section 
1903 for medical assistance consisting of routine patient 
costs (as defined in section 1905(gg)(1)) shall not be taken 
into account in applying subsection (f).’’. 
(e) EFFECTIVE DATE.—
H. R. 133—1811 
(1) IN GENERAL.—The amendments made by this section 
shall apply with respect to items and services furnished on 
or after January 1, 2022. 
(2) EXCEPTION
FOR
STATE
LEGISLATION.—In the case of 
a State plan under title XIX of the Social Security Act (42 
U.S.C. 1396 et seq.), or waiver of such plan, that the Secretary 
of Health and Human Services determines requires State legis-
lation in order for the respective plan to meet any requirement 
imposed by amendments made by this section, the respective 
plan shall not be regarded as failing to comply with the require-
ments of such title solely on the basis of its failure to meet 
such an additional requirement before the first day of the 
first calendar quarter beginning after the close of the first 
regular session of the State legislature that begins after the 
date of the enactment of this Act. For purposes of the previous 
sentence, in the case of a State that has a 2-year legislative 
session, each year of the session shall be considered to be 
a separate regular session of the State legislature. 
TITLE III—HUMAN SERVICES 
SEC. 301. EXTENSION OF TANF, CHILD CARE ENTITLEMENT TO STATES, 
AND RELATED PROGRAMS. 
Activities authorized by part A of title IV and section 1108(b) 
of the Social Security Act shall continue through September 30, 
2021, in the manner authorized for fiscal year 2020, and out of 
any money in the Treasury of the United States not otherwise 
appropriated, there are hereby appropriated such sums as may 
be necessary for such purpose. Grants and payments may be made 
pursuant to this authority on a quarterly basis through the 4th 
quarter of fiscal year 2021 at the level provided for such activities 
for the corresponding quarter of fiscal year 2020. 
SEC. 302. PERSONAL RESPONSIBILITY EDUCATION EXTENSION. 
Section 513 of the Social Security Act (42 U.S.C. 713) is 
amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) in subparagraph (A)— 
(I) in the matter preceding clause (i), by 
striking ‘‘2020 and for the period beginning 
October 1, 2020, and ending December 18, 2020’’ 
and inserting ‘‘2023’’; and 
(II) in clause (i), by striking ‘‘or period’’; 
(ii) in subparagraph (B)(i), by striking the 2nd 
sentence; 
(iii) in subparagraph (C)(i)— 
(I) by striking ‘‘or the period described in 
subparagraph (A)’’; and 
(II) by striking ‘‘or period’’; 
(B) in paragraph (3)— 
(i) by striking ‘‘or the period described in para-
graph (1)(A)’’; and 
(ii) by striking ‘‘or period’’; and 
(C) in paragraph (4)—
H. R. 133—1812 
(i) by striking ‘‘2020 and for the period described 
in paragraph (1)(A)’’ and inserting ‘‘2023’’; 
(ii) by striking ‘‘2020 and for the period so 
described’’ and inserting ‘‘2023’’; and 
(iii) by striking ‘‘or the period so described’’; 
(2) in subsection (c)— 
(A) in each of paragraphs (1) and (2), by striking ‘‘Sub-
ject to paragraph (3), from’’ and inserting ‘‘From’’; and 
(B) by striking paragraph (3); and 
(3) in subsection (f), by striking ‘‘2020, 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 
‘‘2023’’. 
SEC. 303. SEXUAL RISK AVOIDANCE EDUCATION EXTENSION. 
Section 510 of the Social Security Act (42 U.S.C. 710) is 
amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) in the matter preceding subparagraph (A)— 
(I) by striking ‘‘2020 and for the period begin-
ning October 1, 2020, and ending December 18, 
2020’’ and inserting ‘‘2023’’; and 
(II) by striking ‘‘(or, with respect to such 
period, for fiscal year 2021)’’; and 
(ii) in subparagraph (A), by striking ‘‘or period’’ 
each place it appears; 
(B) in paragraph (2)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘2020 and for the period begin-
ning October 1, 2020, and ending December 18, 
2020’’ and inserting ‘‘2023’’; and 
(II) by striking ‘‘(or, with respect to such 
period, for fiscal year 2021)’’; and 
(ii) in subparagraph (B)(i), by striking ‘‘(or, with 
respect to the period described in subparagraph (A), 
for fiscal year 2021)’’; and 
(2) in subsection (f)— 
(A) in paragraph (1), by striking ‘‘2020, 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 ‘‘2023’’; and 
(B) in paragraph (2), by striking ‘‘2020, and for the 
period described in paragraph (1),’’ and inserting ‘‘2023,’’. 
SEC. 304. EXTENSION OF SUPPORT FOR CURRENT HEALTH PROFES-
SIONS OPPORTUNITY GRANTS. 
Out of any money in the Treasury of the United States not 
otherwise appropriated, there are hereby appropriated to the Sec-
retary of Health and Human Services $3,600,000, which shall be 
available— 
(1) through the end of fiscal year 2021 for necessary 
administrative expenses to carry out grants made under section 
2008(a) of the Social Security Act before the date of the enact-
ment of this Act; and
H. R. 133—1813 
(2) through the end of fiscal year 2022 for research, evalua-
tion, and reporting under such section, and for necessary 
administrative expenses to carry out these activities. 
SEC. 305. EXTENSION OF MARYLEE ALLEN PROMOTING SAFE AND 
STABLE FAMILIES PROGRAM AND STATE COURT SUP-
PORT. 
(a) EXTENSIONS.—Section 436 of the Social Security Act (42 
U.S.C. 629f) is amended in each of subsections (a), (b)(4)(A), (b)(5), 
and (f)(10) by striking ‘‘2021’’ and inserting ‘‘2022’’. 
(b) PROGRAM CHANGES.—Section 438 of such Act (42 U.S.C. 
629h) is amended— 
(1) in subsection (a)— 
(A) in paragraph (2)— 
(i) in subparagraph (A), by inserting ‘‘in a timely 
and complete manner’’ before ‘‘, as set forth’’; and 
(ii) in subparagraph (C), by striking the semicolon 
and inserting ‘‘, including by training judges, attorneys, 
and other legal personnel.’’; and 
(B) by striking paragraphs (3) and (4); 
(2) in subsection (b)— 
(A) by striking paragraph (2); 
(B) by striking all that precedes ‘‘be eligible to receive’’ 
and inserting the following: 
‘‘(b) APPLICATIONS.—In order to’’; and 
(C) in the matter preceding paragraph (2)— 
(i) by moving the matter 2 ems to the left; 
(ii) in subparagraph (A)— 
(I) by striking ‘‘(A) in the case of a grant 
for the purpose described in subsection (a)(3),’’ and 
inserting ‘‘(1)’’; and 
(II) by inserting ‘‘use not less than 30 percent 
of grant funds to’’ before ‘‘collaborate’’; 
(iii) in subparagraph (B), by striking ‘‘(B) in the 
case of a grant for the purpose described in subsection 
(a)(4),’’ and inserting ‘‘(2)’’; and 
(iv) in subparagraph (C), by striking ‘‘(C) in the 
case of a grant for the purpose described in subsection 
(a),’’ and inserting ‘‘(3)’’; 
(3) by striking subsection (c) and inserting the following: 
‘‘(c) AMOUNT OF GRANT.— 
‘‘(1) IN GENERAL.—From the amounts reserved under sec-
tions 436(b)(2) and 437(b)(2) for a fiscal year, each highest 
State court that has an application approved under this section 
for the fiscal year shall be entitled to payment of an amount 
equal to the sum of— 
‘‘(A) $255,000; and 
‘‘(B) the amount described in paragraph (2) with 
respect to the court and the fiscal year. 
‘‘(2) AMOUNT DESCRIBED.—The amount described in this 
paragraph with respect to a court and a fiscal year is the 
amount that bears the same ratio to the total of the amounts 
reserved under sections 436(b)(2) and 437(b)(2) for grants under 
this section for the fiscal year (after applying paragraphs (1)(A) 
and (3) of this subsection) as the number of individuals in 
the State in which the court is located who have not attained 
21 years of age bears to the total number of such individuals
H. R. 133—1814 
in all States with a highest State court that has an approved 
application under this section for the fiscal year. 
‘‘(3) INDIAN
TRIBES.—From the amounts reserved under 
section 436(b)(2) for a fiscal year, the Secretary shall, before 
applying paragraph (1) of this subsection, allocate $1,000,000 
for grants to be awarded on a competitive basis among the 
highest courts of Indian tribes or tribal consortia that— 
‘‘(A) are operating a program under part E, in accord-
ance with section 479B; 
‘‘(B) are seeking to operate a program under part E 
and have received an implementation grant under section 
476; or 
‘‘(C) have a court responsible for proceedings related 
to foster care or adoption.’’; and 
(4) in subsection (d), by striking ‘‘2017 through 2021’’ and 
inserting ‘‘2018 through 2022’’. 
(c) EFFECTIVE DATE.—The amendments made by this section 
shall take effect on October 1, 2021. 
TITLE IV—HEALTH OFFSETS 
SEC. 401. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG 
PRICING 
INFORMATION 
WITH 
RESPECT 
TO 
DRUGS 
UNDER THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1847A of the Social Security Act 
(42 U.S.C. 1395w–3a) is amended— 
(1) in subsection (b)— 
(A) in paragraph (2)(A), by inserting ‘‘or subsection 
(f)(2), as applicable’’ before the period at the end; 
(B) in paragraph (3), in the matter preceding subpara-
graph (A), by inserting ‘‘or subsection (f)(2), as applicable,’’ 
before ‘‘determined by’’; and 
(C) in paragraph (6)(A), in the matter preceding clause 
(i), by inserting ‘‘or subsection (f)(2), as applicable,’’ before 
‘‘determined by’’; and 
(2) in subsection (f)— 
(A) by striking ‘‘For requirements’’ and inserting the 
following: 
‘‘(1) IN GENERAL.—For requirements’’; and 
(B) by adding at the end the following new paragraph: 
‘‘(2) MANUFACTURERS
WITHOUT
A
REBATE
AGREEMENT 
UNDER TITLE XIX.— 
‘‘(A) IN GENERAL.—If the manufacturer of a drug or 
biological described in subparagraph (C), (E), or (G) of 
section 1842(o)(1) or in section 1881(b)(14)(B) that is pay-
able under this part has not entered into and does not 
have in effect a rebate agreement described in subsection 
(b) of section 1927, for calendar quarters beginning on 
January 1, 2022, such manufacturer shall report to the 
Secretary 
the 
information 
described 
in 
subsection 
(b)(3)(A)(iii) of such section 1927 with respect to such drug 
or biological in a time and manner specified by the Sec-
retary. For purposes of applying this paragraph, a drug 
or biological described in the previous sentence includes 
items, services, supplies, and products that are payable 
under this part as a drug or biological.
H. R. 133—1815 
‘‘(B) AUDIT.—Information reported under subparagraph 
(A) is subject to audit by the Inspector General of the 
Department of Health and Human Services. 
‘‘(C) VERIFICATION.—The Secretary may survey whole-
salers and manufacturers that directly distribute drugs 
or biologicals described in subparagraph (A), when nec-
essary, to verify manufacturer prices and manufacturer’s 
average sales prices (including wholesale acquisition cost) 
if required to make payment reported under subparagraph 
(A). The Secretary may impose a civil monetary penalty 
in an amount not to exceed $100,000 on a wholesaler, 
manufacturer, or direct seller, if the wholesaler, manufac-
turer, or direct seller of such a drug or biological refuses 
a request for information about charges or prices by the 
Secretary in connection with a survey under this subpara-
graph or knowingly provides false information. The provi-
sions of section 1128A (other than subsections (a) (with 
respect to amounts of penalties or additional assessments) 
and (b)) shall apply to a civil money penalty under this 
subparagraph in the same manner as such provisions apply 
to a penalty or proceeding under section 1128A(a). 
‘‘(D) CONFIDENTIALITY.—Notwithstanding any other 
provision of law, information disclosed by manufacturers 
or wholesalers under this paragraph (other than the whole-
sale acquisition cost for purposes of carrying out this sec-
tion) is confidential and shall not be disclosed by the Sec-
retary in a form which discloses the identity of a specific 
manufacturer or wholesaler or prices charged for drugs 
or biologicals by such manufacturer or wholesaler, except— 
‘‘(i) as the Secretary determines to be necessary 
to carry out this section (including the determination 
and implementation of the payment amount), or to 
carry out section 1847B; 
‘‘(ii) to permit the Comptroller General of the 
United States to review the information provided; 
‘‘(iii) to permit the Director of the Congressional 
Budget Office to review the information provided; 
‘‘(iv) to permit the Medicare Payment Advisory 
Commission to review the information provided; and 
‘‘(v) to permit the Medicaid and CHIP Payment 
and Access Commission to review the information pro-
vided.’’. 
(b) ENFORCEMENT.—Section 1847A of such Act (42 U.S.C. 
1395w–3a) is further amended— 
(1) in subsection (d)(4)— 
(A) in subparagraph (A), by striking ‘‘IN
GENERAL’’ 
and inserting ‘‘MISREPRESENTATION’’; 
(B) in subparagraph (B), by striking ‘‘subparagraph 
(B)’’ and inserting ‘‘subparagraph (A), (B), or (C)’’; 
(C) by redesignating subparagraph (B) as subpara-
graph (E); and 
(D) by inserting after subparagraph (A) the following 
new subparagraphs: 
‘‘(B) FAILURE TO PROVIDE TIMELY INFORMATION.—If the 
Secretary determines that a manufacturer described in sub-
section (f)(2) has failed to report on information described 
in section 1927(b)(3)(A)(iii) with respect to a drug or
H. R. 133—1816 
biological in accordance with such subsection, the Secretary 
shall apply a civil money penalty in an amount of $10,000 
for each day the manufacturer has failed to report such 
information and such amount shall be paid to the Treasury. 
‘‘(C) FALSE INFORMATION.—Any manufacturer required 
to submit information under subsection (f)(2) that know-
ingly provides false information is subject to a civil money 
penalty in an amount not to exceed $100,000 for each 
item of false information. Such civil money penalties are 
in addition to other penalties as may be prescribed by 
law. 
‘‘(D) INCREASING OVERSIGHT AND ENFORCEMENT.—For 
calendar quarters beginning on or after January 1, 2022, 
section 1927(b)(3)(C)(iv) shall be applied as if— 
‘‘(i) each reference to ‘under this subparagraph 
and subsection (c)(4)(B)(ii)(III)’ were a reference to 
‘under this subparagraph, subsection (c)(4)(B)(ii)(III), 
and subparagraphs (A), (B), and (C) of section 
1847A(d)(4)’; and 
‘‘(ii) the reference to ‘activities related to the over-
sight and enforcement of this section and agreements 
under this section’ were a reference to ‘activities related 
to the oversight and enforcement of this section and 
under subsection (f)(2) of section 1847A and subpara-
graphs (A), (B), and (C) of section 1847A(d)(4) and, 
if applicable, agreements under this section’.’’; and 
(2) in subsection (c)(6)(A), by striking the period at the 
end and inserting ‘‘, except that, for purposes of subsection 
(f)(2), the Secretary may, if the Secretary determines appro-
priate, exclude repackagers of a drug or biological from such 
term.’’. 
(c) MANUFACTURERS WITH A REBATE AGREEMENT.— 
(1) IN GENERAL.—Section 1927(b)(3)(A) of the Social Secu-
rity Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by adding 
at the end the following new sentence: ‘‘For purposes of applying 
clause (iii), for calendar quarters beginning on or after January 
1, 2022, a drug or biological described in the flush matter 
following such clause includes items, services, supplies, and 
products that are payable under part B of title XVIII as a 
drug or biological.’’. 
(2) TECHNICAL
AMENDMENT.—Section 1927(b)(3)(A)(iii) of 
the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is 
amended by striking ‘‘section 1881(b)(13)(A)(ii)’’ and inserting 
‘‘section 1881(b)(14)(B)’’. 
(d) REPORT.—Not later than January 1, 2023, the Inspector 
General of the Department of Health and Human Services shall 
assess and submit to Congress a report on the accuracy of average 
sales price information submitted by manufacturers under section 
1847A of the Social Security Act (42 U.S.C. 1395w–3a), including 
the extent to which manufacturers provide false information, 
misclassify drug products, or misreport information. Such report 
shall include any recommendations on how to improve the accuracy 
of such information.
H. R. 133—1817 
SEC. 402. EXTENDED MONTHS OF COVERAGE OF IMMUNOSUPPRESSIVE 
DRUGS FOR KIDNEY TRANSPLANT PATIENTS AND OTHER 
RENAL DIALYSIS PROVISIONS. 
(a) MEDICARE ENTITLEMENT TO IMMUNOSUPPRESSIVE DRUGS FOR 
KIDNEY TRANSPLANT RECIPIENTS.— 
(1) IN GENERAL.—Section 226A(b)(2) of the Social Security 
Act (42 U.S.C. 426–1(b)(2)) is amended by inserting ‘‘(except 
for eligibility for enrollment under part B solely for purposes 
of coverage of immunosuppressive drugs described in section 
1861(s)(2)(J))’’ before ‘‘, with the thirty-sixth month’’. 
(2) INDIVIDUALS ELIGIBLE ONLY FOR COVERAGE OF IMMUNO-
SUPPRESSIVE DRUGS.— 
(A) IN GENERAL.—Section 1836 of the Social Security 
Act (42 U.S.C. 1395o) is amended— 
(i) by striking ‘‘Every’’ and inserting ‘‘(a) IN GEN-
ERAL.—Every’’; and 
(ii) by adding at the end the following new sub-
section: 
‘‘(b) INDIVIDUALS ELIGIBLE FOR IMMUNOSUPPRESSIVE DRUG COV-
ERAGE.— 
‘‘(1) IN
GENERAL.—Except as provided under paragraph 
(2), every individual whose entitlement to insurance benefits 
under part A ends (whether before, on, or after January 1, 
2023) by reason of section 226A(b)(2) is eligible to enroll or 
to be deemed to have enrolled in the medical insurance program 
established by this part solely for purposes of coverage of 
immunosuppressive drugs in accordance with section 1837(n). 
‘‘(2) EXCEPTION IF OTHER COVERAGE IS AVAILABLE.— 
‘‘(A) IN GENERAL.—An individual described in para-
graph (1) shall not be eligible for enrollment in the program 
for purposes of coverage described in such paragraph with 
respect to any period in which the individual, as determined 
in accordance with subparagraph (B)— 
‘‘(i) is enrolled in a group health plan or group 
or individual health insurance coverage, as such terms 
are defined in section 2791 of the Public Health Service 
Act; 
‘‘(ii) is enrolled for coverage under the TRICARE 
for Life program under section 1086(d) of title 10, 
United States Code; 
‘‘(iii) is enrolled under a State plan (or waiver 
of such plan) under title XIX and is eligible to receive 
benefits for immunosuppressive drugs described in this 
subsection under such plan (or such waiver); 
‘‘(iv) is enrolled under a State child health plan 
(or waiver of such plan) under title XXI and is eligible 
to receive benefits for such drugs under such plan 
(or such waiver); or 
‘‘(v)(I) is enrolled in the patient enrollment system 
of the Department of Veterans Affairs established and 
operated under section 1705 of title 38, United States 
Code; 
‘‘(II) is not required to enroll under section 1705 
of such title to receive immunosuppressive drugs 
described in this subsection; or 
‘‘(III) is otherwise eligible under a provision of 
title 38, United States Code, other than section 1710
H. R. 133—1818 
of such title to receive immunosuppressive drugs 
described in this subsection. 
‘‘(B) ELIGIBILITY DETERMINATIONS.— 
‘‘(i) IN GENERAL.—The Secretary, in coordination 
with the Commissioner of Social Security, shall estab-
lish a process for determining whether an individual 
described in paragraph (1) who is to be enrolled or 
deemed to be enrolled in the medical insurance pro-
gram described in such paragraph meets the require-
ments for such enrollment under this subsection, 
including the requirement that the individual not be 
enrolled in other coverage as described in subpara-
graph (A). 
‘‘(ii) ATTESTATION REGARDING OTHER COVERAGE.— 
The process established under clause (i) shall include, 
at a minimum, a requirement that— 
‘‘(I) the individual provide to the Commissioner 
an attestation that the individual is not enrolled 
and does not expect to enroll in such other cov-
erage; and 
‘‘(II) the individual notify the Commissioner 
within 60 days of enrollment in such other cov-
erage.’’. 
(B) CONFORMING AMENDMENT.— 
(i) IN GENERAL.—Sections 1837, 1838, and 1839 
of the Social Security Act (42 U.S.C. 1395p, 42 U.S.C. 
1395q, 42 U.S.C. 1395r) are each amended by striking 
‘‘1836’’ and inserting ‘‘1836(a)’’ each place it appears. 
(ii) ADDITIONAL AMENDMENT.—Section 1837(j)(1) of 
such Act (42 U.S.C. 1395p(j)(1)) is amended by striking 
‘‘1836(1)’’ and inserting ‘‘1836(a)(1)’’. 
(b) ENROLLMENT FOR INDIVIDUALS ONLY ELIGIBLE FOR COV-
ERAGE OF IMMUNOSUPPRESSIVE DRUGS.—Section 1837 of the Social 
Security Act (42 U.S.C. 1395p), as amended by section 120, is 
amended by adding at the end the following new subsection: 
‘‘(n)(1) Any individual who is eligible for coverage of immuno-
suppressive drugs under section 1836(b) may enroll or be deemed 
to have enrolled only in such manner and form as may be prescribed 
by regulations, and only during an enrollment period described 
in this subsection. 
‘‘(2) An individual described in paragraph (1) whose entitlement 
for hospital insurance benefits under part A ends by reason of 
section 226A(b)(2) prior to January 1, 2023, may enroll beginning 
on October 1, 2022, or the day on which the individual first satisfies 
section 1836(b), whichever is later. 
‘‘(3) An individual described in paragraph (1) whose entitlement 
for hospital insurance benefits under part A ends by reason of 
section 226A(b)(2) on or after January 1, 2023, shall be deemed 
to have enrolled in the medical insurance program established 
by this part for purposes of coverage of immunosuppressive drugs. 
‘‘(4) The Secretary shall establish a process under which an 
individual described in paragraph (1) whose other coverage 
described in section 1836(b)(2)(A), or coverage under this part 
(including the medical insurance program established under this 
part for purposes of coverage of immunosuppressive drugs), is termi-
nated voluntarily or involuntary may enroll or reenroll, if applicable,