148 
lic and written in plain language that consumers can read-
ily understand, an annual report— 
‘‘(1) summarizing the information reported pur-
suant to section 1150C; 
‘‘(2) including copies of the reports and sup-
porting detailed economic analyses submitted pursu-
ant to such section; 
‘‘(3) detailing the costs and expenditures in-
curred by the Department of Health and Human 
Services in carrying out section 1150C; and 
‘‘(4) explaining how the Department of Health 
and Human Services is improving consumer and 
provider information about drug value and drug 
price transparency. 
‘‘(b) PROTECTED INFORMATION.—In carrying out 
this section, the Secretary shall enforce applicable law con-
cerning the protection of confidential commercial informa-
tion and trade secrets.’’.
149 
TITLE V—PROGRAM IMPROVE-
MENTS FOR MEDICARE LOW- 
INCOME BENEFICIARIES 
SEC. 501. DISSEMINATION TO MEDICARE PART D SUBSIDY 
ELIGIBLE INDIVIDUALS OF INFORMATION 
COMPARING PREMIUMS OF CERTAIN PRE-
SCRIPTION DRUG PLANS. 
Section 1860D–1(c)(3) of the Social Security Act (42 
U.S.C. 1395w–101(c)(3)) is amended by adding at the end 
the following new subparagraph: 
‘‘(C) INFORMATION
ON
PREMIUMS
FOR 
SUBSIDY ELIGIBLE INDIVIDUALS.— 
‘‘(i) IN
GENERAL.—For plan year 
2022 and each subsequent plan year, the 
Secretary shall disseminate to each subsidy 
eligible individual (as defined in section 
1860D–14(a)(3)) information under this 
paragraph comparing premiums that would 
apply to such individual for prescription 
drug coverage under LIS benchmark plans, 
including, in the case of an individual en-
rolled in a prescription drug plan under 
this part, information that compares the 
premium that would apply if such indi-
vidual were to remain enrolled in such plan
150 
to premiums that would apply if the indi-
vidual were to enroll in other LIS bench-
mark plans. 
‘‘(ii) LIS BENCHMARK
PLAN.—For 
purposes of clause (i), the term ‘LIS 
benchmark plan’ means, with respect to an 
individual, a prescription drug plan under 
this part that is offered in the region in 
which the individual resides and— 
‘‘(I) that provides for a premium 
that is not more than the low-income 
benchmark premium amount (as de-
fined in section 1860D–14(b)(2)) for 
such region; or 
‘‘(II) with respect to which the 
premium would be waived as de mini-
mis pursuant to section 1860D– 
14(a)(5) for such individual.’’. 
SEC. 502. PROVIDING FOR INTELLIGENT ASSIGNMENT OF 
CERTAIN SUBSIDY ELIGIBLE INDIVIDUALS 
AUTO-ENROLLED 
UNDER 
MEDICARE 
PRE-
SCRIPTION DRUG PLANS AND MA–PD PLANS. 
(a) IN GENERAL.—Section 1860D–1(b)(1) of the So-
cial Security Act (42 U.S.C. 1395w–101(b)(1)) is amend-
ed—
151 
(1) in subparagraph (C)— 
(A) by inserting after ‘‘PDP region’’ the 
following: ‘‘or through use of an intelligent as-
signment process that is designed to maximize 
the access of such individual to necessary pre-
scription drugs while minimizing costs to such 
individual and to the program under this part 
to the greatest extent possible. In the case the 
Secretary enrolls such individuals through use 
of an intelligent assignment process, such proc-
ess shall take into account the extent to which 
prescription drugs necessary for the individual 
are covered in the case of a PDP sponsor of a 
prescription drug plan that uses a formulary, 
the use of prior authorization or other restric-
tions on access to coverage of such prescription 
drugs by such a sponsor, and the overall quality 
of a prescription drug plan as measured by 
quality ratings established by the Secretary’’; 
and 
(B) by striking ‘‘Nothing in the previous 
sentence’’ and inserting ‘‘Nothing in this sub-
paragraph’’; and 
(2) in subparagraph (D)—
152 
(A) by inserting after ‘‘PDP region’’ the 
following: ‘‘or through use of an intelligent as-
signment process that is designed to maximize 
the access of such individual to necessary pre-
scription drugs while minimizing costs to such 
individual and to the program under this part 
to the greatest extent possible. In the case the 
Secretary enrolls such individuals through use 
of an intelligent assignment process, such proc-
ess shall take into account the extent to which 
prescription drugs necessary for the individual 
are covered in the case of a PDP sponsor of a 
prescription drug plan that uses a formulary, 
the use of prior authorization or other restric-
tions on access to coverage of such prescription 
drugs by such a sponsor, and the overall quality 
of a prescription drug plan as measured by 
quality ratings established by the Secretary’’; 
and 
(B) by striking ‘‘Nothing in the previous 
sentence’’ and inserting ‘‘Nothing in this sub-
paragraph’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply with respect to plan years begin-
ning with plan year 2022.
153 
SEC. 503. EXPANDING ELIGIBILITY FOR LOW-INCOME SUB-
SIDIES UNDER PART D OF THE MEDICARE 
PROGRAM. 
Section 1860D–14(a) of the Social Security Act (42 
U.S.C. 1395w–114(a)), as amended by section 301(d), is 
further amended— 
(1) in the subsection heading, by striking ‘‘IN-
DIVIDUALS’’ and all that follows through ‘‘LINE’’ 
and inserting ‘‘CERTAIN INDIVIDUALS’’; 
(2) in paragraph (1)— 
(A) by striking the paragraph heading and 
inserting ‘‘INDIVIDUALS WITH CERTAIN LOW IN-
COMES’’; and 
(B) in the matter preceding subparagraph 
(A), by inserting ‘‘(or, with respect to a plan 
year beginning on or after January 1, 2022, 
150 percent)’’ after ‘‘135 percent’’; and 
(3) in paragraph (2)— 
(A) by striking the paragraph heading and 
inserting ‘‘OTHER LOW-INCOME INDIVIDUALS’’; 
and 
(B) in the matter preceding subparagraph 
(A), by striking ‘‘In the case of a subsidy’’ and 
inserting ‘‘With respect to a plan year begin-
ning before January 1, 2022, in the case of a 
subsidy’’.
154 
SEC. 504. AUTOMATIC ELIGIBILITY OF CERTAIN LOW-IN-
COME TERRITORIAL RESIDENTS FOR PRE-
MIUM AND COST-SHARING SUBSIDIES UNDER 
THE MEDICARE PROGRAM; SUNSET OF EN-
HANCED ALLOTMENT PROGRAM. 
(a) AUTOMATIC ELIGIBILITY OF CERTAIN LOW-IN-
COME TERRITORIAL RESIDENTS
FOR PREMIUM
AND 
COST-SHARING SUBSIDIES UNDER THE MEDICARE PRO-
GRAM.— 
(1) IN GENERAL.—Section 1860D–14(a)(3) of 
the Social Security Act (42 U.S.C. 1395w– 
114(a)(3)) is amended— 
(A) in subparagraph (B)(v)— 
(i) in subclause (I), by striking ‘‘and’’ 
at the end; 
(ii) in subclause (II), by striking the 
period and inserting ‘‘; and’’; and 
(iii) by inserting after subclause (II) 
the following new subclause: 
‘‘(III) with respect to plan years 
beginning on or after January 1, 
2024, shall provide that any part D 
eligible individual who is enrolled for 
medical assistance under the State 
Medicaid plan of a territory (as de-
fined in section 1935(f)) under title
155 
XIX (or a waiver of such a plan) shall 
be treated as a subsidy eligible indi-
vidual described in paragraph (1).’’; 
and 
(B) in subparagraph (F), by adding at the 
end the following new sentence: ‘‘The previous 
sentence shall not apply with respect to eligi-
bility determinations for premium and cost- 
sharing subsidies under this section made on or 
after January 1, 2024.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1860D–31(j)(2)(D) of the Social Security Act (42 
U.S.C. 1395w–141(j)(2)(D)) is amended by adding 
at the end the following new sentence: ‘‘The previous 
sentence shall not apply with respect to amounts 
made available to a State under this paragraph on 
or after January 1, 2024.’’. 
(b) SUNSET
OF
ENHANCED
ALLOTMENT
PRO-
GRAM.— 
(1) IN GENERAL.—Section 1935(e) of the So-
cial Security Act (42 U.S.C. 1396u–5(e)) is amend-
ed— 
(A) in paragraph (1)(A), by inserting after 
‘‘such State’’ the following: ‘‘before January 1, 
2021’’; and
156 
(B) in paragraph (3)— 
(i) in subparagraph (A), in the matter 
preceding clause (i), by inserting after ‘‘a 
year’’ the following: ‘‘(before 2024)’’; and 
(ii) in subparagraph (B)(iii), by strik-
ing ‘‘a subsequent year’’ and inserting 
‘‘each of fiscal years 2008 through 2023’’. 
(2) TERRITORY DEFINED.—Section 1935 of the 
Social Security Act (42 U.S.C. 1396u–5) is amended 
by adding at the end the following new subsection: 
‘‘(f) TERRITORY DEFINED.—In this section, the term 
‘territory’ means Puerto Rico, the Virgin Islands, Guam, 
the Northern Mariana Islands, and American Samoa.’’. 
SEC. 505. AUTOMATIC QUALIFICATION OF CERTAIN MED-
ICAID BENEFICIARIES FOR PREMIUM AND 
COST-SHARING SUBSIDIES UNDER PART D OF 
THE MEDICARE PROGRAM. 
Clause (v) of section 1860D–14(a)(3)(B) of the So-
cial Security Act (42 U.S.C. 1395w–114(a)(3)(B)), as 
amended by section 504, is further amended— 
(1) in subclause (II), by striking ‘‘and’’ at the 
end; 
(2) in subclause (III), by striking the period 
and inserting ‘‘; and’’; and
157 
(3) by inserting after subclause (III) the fol-
lowing new subclause: 
‘‘(IV) with respect to plan years 
beginning on or after January 1, 
2024, shall, notwithstanding the pre-
ceding clauses of this subparagraph, 
provide that any part D eligible indi-
vidual not described in subclause (I), 
(II), or (III) who is enrolled, as of the 
day before the date on which such in-
dividual attains the age of 65, for 
medical assistance under a State plan 
under title XIX (or a waiver of such 
plan) pursuant to clause (i)(VIII) or 
(ii)(XX) of section 1902(a)(10)(A), 
and who has income below 200 per-
cent of the poverty line applicable to 
a family of the size involved, shall be 
treated as a subsidy eligible individual 
described in paragraph (1) for a lim-
ited period of time, as specified by the 
Secretary.’’.
158 
SEC. 506. PROVIDING FOR CERTAIN RULES REGARDING 
THE TREATMENT OF ELIGIBLE RETIREMENT 
PLANS IN DETERMINING THE ELIGIBILITY OF 
INDIVIDUALS 
FOR 
PREMIUM 
AND 
COST- 
SHARING SUBSIDIES UNDER PART D OF THE 
MEDICARE PROGRAM. 
Section 1860D–14(a)(3)(C)(i) of the Social Security 
Act (42 U.S.C. 1395w–114(a)(3)(C)(i)) is amended, by 
striking ‘‘except that support and maintenance furnished 
in kind shall not be counted as income; and’’ and inserting 
‘‘except that— 
‘‘(I) support and maintenance 
furnished in kind shall not be counted 
as income; and 
‘‘(II) for plan years beginning on 
or after January 1, 2024, any dis-
tribution or withdrawal from an eligi-
ble retirement plan (as defined in sub-
paragraph (B) of section 402(c)(8) of 
the Internal Revenue Code of 1986, 
but excluding any defined benefit plan 
described in clause (iv) or (v) of such 
subparagraph and any qualified trust 
(as defined in subparagraph (A) of 
such section) which is part of such a
159 
defined benefit plan) shall be counted 
as income; and’’. 
SEC. 507. REDUCING COST-SHARING AND OTHER PROGRAM 
IMPROVEMENTS 
FOR 
LOW-INCOME 
BENE-
FICIARIES. 
(a) INCREASE IN INCOME ELIGIBILITY TO 150 PER-
CENT
OF
FPL FOR
QUALIFIED
MEDICARE
BENE-
FICIARIES.— 
(1) IN GENERAL.—Section 1905(p)(2)(A) of the 
Social Security Act (42 U.S.C. 1396d(p)(2)(A)) is 
amended by striking ‘‘shall be at least the percent 
provided under subparagraph (B) (but not more 
than 100 percent) of the official poverty line’’ and 
all that follows through the period at the end and 
inserting the following: ‘‘shall be— 
‘‘(i) before January 1, 2022, at least 
the percent provided under subparagraph 
(B) (but not more than 100 percent) of 
the official poverty line (as defined by the 
Office of Management and Budget, and re-
vised annually in accordance with section 
673(2) of the Omnibus Budget Reconcili-
ation Act of 1981) applicable to a family 
of the size involved; and
160 
‘‘(ii) on or after January 1, 2022, 
equal to 150 percent of the official poverty 
line (as so defined and revised) applicable 
to a family of the size involved.’’. 
(2) NOT
COUNTING
IN-KIND
SUPPORT
AND 
MAINTENANCE AS INCOME.—Section 1905(p)(2)(D) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1396d(p)(2)(D)) is amended by adding at the end 
the following new clause: 
‘‘(iii) In determining income under 
this subsection, support and maintenance 
furnished in kind, as described in section 
1612(a)(2)(A), shall not be counted as in-
come.’’. 
(3) CONFORMING AMENDMENTS.— 
(A) Section 1902(a)(10)(E) of the Social 
Security Act (42 U.S.C. 1396a(a)(10)(E)) is 
amended— 
(i) in clause (iii), by striking ‘‘for 
making medical’’ and inserting ‘‘before 
January 1, 2022, for making medical’’; 
and 
(ii) in clause (iv), by striking ‘‘subject 
to sections’’ and inserting ‘‘before January 
1, 2022, subject to sections’’.
161 
(B) Section 1933 of the Social Security 
Act (42 U.S.C. 1396u–3) is amended— 
(i) in subsection (a), by striking ‘‘A 
State plan’’ and inserting ‘‘Subject to sub-
section (h), a State plan’’; and 
(ii) by adding at the end the following 
new subsection: 
‘‘(h) SUNSET.—The provisions of this section shall 
have no force or effect after December 31, 2021.’’. 
(b) 100 PERCENT FMAP.—Section 1905 of the So-
cial Security Act (42 U.S.C. 1396d) is amended by adding 
at the end the following new subsection: 
‘‘(gg) INCREASED FMAP FOR EXPANDED MEDICARE 
COST-SHARING POPULATIONS.— 
‘‘(1) IN GENERAL.—Notwithstanding subsection 
(b), with respect to expenditures described in para-
graph (2) the Federal medical assistance percentage 
shall be equal to 100 percent. 
‘‘(2) EXPENDITURES DESCRIBED.—The expend-
itures described in this paragraph are expenditures 
made on or after January 1, 2022, for medical as-
sistance for medicare cost-sharing provided to any 
individual under clause (i) or (ii) of section 
1902(a)(10)(E) who would not have been eligible for 
medicare cost-sharing under any such clause under
162 
the income or resource eligibility standards in effect 
on October 1, 2018.’’. 
TITLE VI—PROVIDING FOR DEN-
TAL, VISION, AND HEARING 
COVERAGE UNDER THE MEDI-
CARE PROGRAM 
SEC. 601. DENTAL AND ORAL HEALTH CARE. 
(a) COVERAGE.—Section 1861(s)(2) of the Social Se-
curity Act (42 U.S.C. 1395x(s)(2)) is amended— 
(1) in subparagraph (GG), by striking ‘‘and’’ 
after the semicolon at the end; 
(2) in subparagraph (HH), by striking the pe-
riod at the end and adding ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(II) dental and oral health services (as defined 
in subsection (kkk));’’. 
(b) DENTAL
AND ORAL HEALTH SERVICES DE-
FINED.—Section 1861 of the Social Security Act (42 
U.S.C. 1395x) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(kkk) DENTAL AND ORAL HEALTH SERVICES.— 
‘‘(1) IN GENERAL.—The term ‘dental and oral 
health services’ means items and services (other 
than such items and services for which payment may
163 
be made under part A as inpatient hospital services) 
that are furnished during 2025 or a subsequent 
year, for which coverage was not provided under 
part B as of the date of the enactment of this sub-
section, and that are— 
‘‘(A) the preventive and screening services 
described in paragraph (2) furnished by a doc-
tor of dental surgery or of dental medicine (as 
described in subsection (r)(2)) or an oral health 
professional (as defined in paragraph (4)); or 
‘‘(B) the basic treatments specified for 
such year by the Secretary pursuant to para-
graph (3)(A) and the major treatments speci-
fied for such year by the Secretary pursuant to 
paragraph (3)(B) furnished by such a doctor or 
such a professional. 
‘‘(2) PREVENTIVE
AND
SCREENING
SERV-
ICES.—The preventive and screening services de-
scribed in this paragraph are the following: 
‘‘(A) Oral exams. 
‘‘(B) Dental cleanings. 
‘‘(C) Dental x-rays performed in the office 
of a doctor or professional described in para-
graph (1)(A). 
‘‘(D) Fluoride treatments.
164 
‘‘(3) BASIC
AND
MAJOR
TREATMENTS.—For 
2025 and each subsequent year, the Secretary shall 
specify— 
‘‘(A) basic treatments (which may include 
basic tooth restorations, basic periodontic serv-
ices, tooth extractions, and oral disease man-
agement services); and 
‘‘(B) major treatments (which may include 
major tooth restorations, major periodontic 
services, bridges, crowns, and root canals); 
that shall be included as dental and oral health serv-
ices for such year. 
‘‘(4) ORAL HEALTH PROFESSIONAL.—The term 
‘oral health professional’ means, with respect to den-
tal and oral health services, a health professional 
who is licensed to furnish such services, acting with-
in the scope of such license, by the State in which 
such services are furnished.’’. 
(c) PAYMENT; COINSURANCE; AND LIMITATIONS.— 
(1) IN GENERAL.—Section 1833(a)(1) of the 
Social Security Act (42 U.S.C. 1395l(a)(1)) is 
amended— 
(A) in subparagraph (N), by inserting 
‘‘and dental and oral health services (as defined
165 
in 
section 
1861(kkk))’’ 
after 
‘‘section 
1861(hhh)(1))’’; 
(B) by striking ‘‘and’’ before ‘‘(CC)’’; and 
(C) by inserting before the semicolon at 
the end the following: ‘‘, and (DD) with respect 
to dental and oral health services (as defined in 
section 1861(kkk)), the amount paid shall be 
the payment amount specified under section 
1834(x)’’. 
(2) PAYMENT AND LIMITS SPECIFIED.—Section 
1834 of the Social Security Act (42 U.S.C. 1395m) 
is amended by adding at the end the following new 
subsection: 
‘‘(x) PAYMENT AND LIMITS FOR DENTAL AND ORAL 
HEALTH SERVICES.— 
‘‘(1) IN
GENERAL.—The payment amount 
under this part for dental and oral health services 
(as defined in section 1861(kkk)) shall be, subject to 
paragraph (3), the applicable percent (specified in 
paragraph (2)) of the lesser of the actual charge for 
the services or the amount determined under the 
payment basis determined under section 1848. In 
determining such amounts determined under such 
payment basis, the Secretary shall consider payment 
rates paid to dentists for comparable services under
166 
State plans under title XIX, under the TRICARE 
program under chapter 55 of title 10 of the United 
States Code, and by other health care payers, such 
as Medicare Advantage plans under part C. 
‘‘(2) APPLICABLE PERCENT.—For purposes of 
paragraph (1), the applicable percent specified in 
this paragraph is, with respect to dental and oral 
health services (as defined in section 1861(kkk)) fur-
nished in a year— 
‘‘(A) that are preventive and screening 
services described in paragraph (2) or basic 
treatments specified for such year pursuant to 
paragraph (3)(A) of such section, 80 percent; 
and 
‘‘(B) that are major treatments specified 
for such year pursuant to paragraph (3)(B) of 
such section— 
‘‘(i) in the case such services are fur-
nished during 2025, 10 percent; 
‘‘(ii) in the case such services are fur-
nished during 2026 or a subsequent year 
before 2029, the applicable percent speci-
fied under this subparagraph for the pre-
vious year, increased by 10 percentage 
points; and
167 
‘‘(iii) in the case such services are fur-
nished during 2029 or a subsequent year, 
50 percent. 
‘‘(3) LIMITATIONS.—With respect to dental and 
oral health services that are— 
‘‘(A) preventive and screening oral exams, 
payment may be made under this part for not 
more than two such exams during a 12-month 
period; 
‘‘(B) dental cleanings, payment may be 
made under this part for not more than two 
such cleanings during a 12-month period; and 
‘‘(C) not described in subparagraph (A) or 
(B), payment may be made under this part only 
at such frequencies and under such cir-
cumstances determined appropriate by the Sec-
retary.’’. 
(d) PAYMENT UNDER PHYSICIAN FEE SCHEDULE.— 
(1) IN
GENERAL.—Section 1848(j)(3) of the 
Social Security Act (42 U.S.C. 1395w–4(j)(3)) is 
amended by inserting ‘‘(2)(II),’’ before ‘‘(3)’’. 
(2) 
EXCLUSION
FROM
MIPS.—Section 
1848(q)(1)(C)(ii) of the Social Security Act (42 
U.S.C. 1395w–4(q)(1)(C)(ii)) is amended—
168 
(A) in subclause (II), by striking ‘‘or’’ at 
the end; 
(B) in subclause (III), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following new 
subclause: 
‘‘(IV) with respect to 2025 and 
each subsequent year, is a doctor of 
dental surgery or of dental medicine 
(as described in section 1861(r)(2)) or 
is an oral health professional (as de-
fined in section 1861(kkk)(4)).’’. 
(3) INCLUSION
OF
ORAL
HEALTH
PROFES-
SIONALS
AS
CERTAIN
PRACTITIONERS.—Section 
1842(b)(18)(C) of the Social Security Act (42 
U.S.C. 1395u(b)(18)(C)) is amended by adding at 
the end the following new clause: 
‘‘(vii) With respect to 2025 and each subse-
quent year, an oral health professional (as defined in 
section 1861(kkk)(4)).’’. 
(e) DENTURES.— 
(1) IN
GENERAL.—Section 1861(s)(8) of the 
Social Security Act (42 U.S.C. 1395x(s)(8)) is 
amended— 
(A) by striking ‘‘(other than dental)’’; and
169 
(B) by inserting ‘‘and excluding dental, ex-
cept for a full or partial set of dentures fur-
nished on or after January 1, 2025’’ after ‘‘co-
lostomy care’’. 
(2) SPECIAL PAYMENT RULES.— 
(A) LIMITATIONS.—Section 1834(h) of the 
Social Security Act (42 U.S.C. 1395m(h)) is 
amended by adding at the end the following 
new paragraph: 
‘‘(6) SPECIAL
PAYMENT
RULE
FOR
DEN-
TURES.—Payment may be made under this part 
with respect to an individual for dentures— 
‘‘(A) not more than once during any 5-year 
period (except in the case that a doctor or pro-
fessional described in section 1861(kkk)(1)(A) 
determines such dentures do not fit the indi-
vidual); and 
‘‘(B) only to the extent that such dentures 
are furnished pursuant to a written order of 
such a doctor or professional.’’. 
(B) APPLICATION OF COMPETITIVE ACQUI-
SITION.— 
(i) 
IN
GENERAL.—Section 
1834(h)(1)(H) of the Social Security Act 
(42 U.S.C. 1395m(h)(1)(H)) is amended—
170 
(I) in the subparagraph heading, 
by inserting ‘‘, 
DENTURES’’ after 
‘‘ORTHOTICS’’; 
(II) by inserting ‘‘, of dentures 
described in paragraph (2)(D) of such 
section,’’ after ‘‘2011,’’; and 
(III) in clause (i), by inserting ‘‘, 
such dentures’’ after ‘‘orthotics’’. 
(ii) CONFORMING AMENDMENT.—Sec-
tion 1847(a)(2) of the Social Security Act 
(42 U.S.C. 1395w–3(a)(2)) is amended by 
adding at the end the following new sub-
paragraph: 
‘‘(D) DENTURES.—Dentures described in 
section 1861(s)(8) for which payment would 
otherwise be made under section 1834(h).’’. 
(iii) EXEMPTION OF CERTAIN ITEMS 
FROM
COMPETITIVE
ACQUISITION.—Sec-
tion 1847(a)(7) of the Social Security Act 
(42 U.S.C. 1395w–3(a)(7)) is amended by 
adding at the end the following new sub-
paragraph: 
‘‘(C) CERTAIN
DENTURES.—Those items 
and services described in paragraph (2)(D) if 
furnished by a physician or other practitioner
172 
oral health services that are covered under section 
1861(s)(2)(II)’’. 
(g) CERTAIN NON-APPLICATION.— 
(1) IN GENERAL.—Paragraphs (1) and (4) of 
section 1839(a) of the Social Security Act (42 
U.S.C. 1395r(a)) are amended by adding at the end 
of each such paragraphs the following: ‘‘In applying 
this paragraph there shall not be taken into account 
benefits and administrative costs attributable to the 
amendments made by section 601 (other than sub-
section (g)) of the Elijah E. Cummings Lower Drug 
Costs Now Act and the Government contribution 
under section 1844(a)(4)’’. 
(2) PAYMENT.—Section 1844(a) of such Act 
(42 U.S.C. 1395w(a)) is amended— 
(A) in paragraph (3), by striking the pe-
riod at the end and inserting ‘‘; plus’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(4) a Government contribution equal to the 
amount that is estimated to be payable for benefits 
and related administrative costs incurred that are 
attributable to the amendments made by section 601 
(other than subsection (g)) of the Elijah E. Cum-
mings Lower Drug Costs Now Act.’’.
173 
(h) IMPLEMENTATION FUNDING.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this subsection referred to as 
the ‘‘Secretary’’) shall provide for the transfer from 
the Federal Supplementary Medical Insurance Trust 
Fund under section 1841 of the Social Security Act 
(42 U.S.C. 1395t) to the Centers for Medicare & 
Medicaid Services Program Management Account 
of— 
(A) $20,000,000 for each of fiscal years 
2020 through 2025 for purposes of imple-
menting the amendments made by this section; 
and 
(B) such sums as determined appropriate 
by the Secretary for each subsequent fiscal year 
for purposes of administering the provisions of 
such amendments. 
(2) AVAILABILITY
AND
ADDITIONAL
USE
OF 
FUNDS.—Funds transferred pursuant to paragraph 
(1) shall remain available until expended and may be 
used, in addition to the purpose specified in para-
graph (1)(A), to implement the amendments made 
by sections 602 and 603.
174 
SEC. 602. PROVIDING COVERAGE FOR HEARING CARE 
UNDER THE MEDICARE PROGRAM. 
(a) PROVISION
OF AURAL REHABILITATION
AND 
TREATMENT SERVICES BY QUALIFIED AUDIOLOGISTS.— 
Section 1861(ll)(3) of the Social Security Act (42 U.S.C. 
1395x(ll)(3)) is amended by inserting ‘‘(and, beginning 
January 1, 2023, such aural rehabilitation and treatment 
services)’’ after ‘‘assessment services’’. 
(b) COVERAGE OF HEARING AIDS.— 
(1) INCLUSION
OF
HEARING
AIDS
AS
PROS-
THETIC DEVICES.—Section 1861(s)(8) of the Social 
Security Act (42 U.S.C. 1395x(s)(8)) is amended by 
inserting ‘‘, and including hearing aids furnished on 
or after January 1, 2023, to individuals diagnosed 
with profound or severe hearing loss’’ before the 
semicolon at the end. 
(2) PAYMENT
LIMITATIONS
FOR
HEARING 
AIDS.—Section 1834(h) of the Social Security Act 
(42 U.S.C. 1395m(h)), as amended by section 
601(e)(2)(A), is further amended by adding at the 
end the following new paragraph: 
‘‘(7) LIMITATIONS FOR HEARING AIDS.—Pay-
ment may be made under this part with respect to 
an individual, with respect to hearing aids furnished 
on or after January 1, 2023—
175 
‘‘(A) not more than once during a 5-year 
period; 
‘‘(B) only for types of such hearing aids 
that are not over-the-counter hearing aids (as 
defined in section 520(q)(1) of the Federal 
Food, Drug, and Cosmetic Act) and that are 
determined appropriate by the Secretary; and 
‘‘(C) only if furnished pursuant to a writ-
ten order of a physician or qualified audiologist 
(as defined in section 1861(ll)(4)(B)).’’. 
(3) APPLICATION
OF
COMPETITIVE
ACQUISI-
TION.— 
(A) IN GENERAL.—Section 1834(h)(1)(H) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395m(h)(1)(H)), 
as 
amended 
by 
section 
601(e)(2)(B)(i), is further amended— 
(i) in the header, by inserting ‘‘, 
HEARING AIDS’’ after ‘‘DENTURES’’; 
(ii) by inserting ‘‘, of hearing aids de-
scribed in paragraph (2)(E) of such sec-
tion,’’ after ‘‘paragraph (2)(D) of such sec-
tion’’; and 
(iii) in clause (i), by inserting ‘‘, such 
hearing aids’’ after ‘‘such dentures’’. 
(B) CONFORMING AMENDMENT.—
176 
(i) IN GENERAL.—Section 1847(a)(2) 
of the Social Security Act (42 U.S.C. 
1395w–3(a)(2)), as amended by section 
601(e)(2)(B)(ii), is further amended by 
adding at the end the following new sub-
paragraph: 
‘‘(E) HEARING
AIDS.—Hearing aids de-
scribed in section 1861(s)(8) for which payment 
would 
otherwise 
be 
made 
under 
section 
1834(h).’’. 
(ii) EXEMPTION
OF
CERTAIN
ITEMS 
FROM
COMPETITIVE
ACQUISITION.—Sec-
tion 1847(a)(7) of the Social Security Act 
(42 U.S.C. 1395w–3(a)(7)), as amended 
by section 601(e)(2)(B)(iii), is further 
amended by adding at the end the fol-
lowing new subparagraph: 
‘‘(D) CERTAIN
HEARING
AIDS.—Those 
items and services described in paragraph 
(2)(E) if furnished by a physician or other 
practitioner (as defined by the Secretary) to the 
physician’s or practitioner’s own patients as 
part of the physician’s or practitioner’s profes-
sional service.’’.
177 
(4) INCLUSION OF AUDIOLOGISTS AS CERTAIN 
PRACTITIONERS TO RECEIVE PAYMENT ON AN AS-
SIGNMENT-RELATED
BASIS.—Section 
1842(b)(18)(C) of the Social Security Act (42 
U.S.C. 1395u(b)(18)(C)), as amended by section 
601(d)(4), is further amended by adding at the end 
the following new clause: 
‘‘(viii) With respect to 2023 and each 
subsequent year, a qualified audiologist (as 
defined in section 1861(ll)(4)(B)).’’. 
(c) EXCLUSION MODIFICATION.—Section 1862(a)(7) 
of the Social Security Act (42 U.S.C. 1395y(a)(7)) is 
amended by inserting ‘‘(except such hearing aids or exami-
nations therefor as described in and otherwise allowed 
under section 1861(s)(8))’’ after ‘‘hearing aids or exami-
nations therefor’’. 
(d) CERTAIN NON-APPLICATION.— 
(1) IN GENERAL.—The last sentence of section 
1839(a)(1) of the Social Security Act (42 U.S.C. 
1395r(a)(1)), as added by section 601(g)(1), is 
amended by striking ‘‘section 601 (other than sub-
section (g))’’ and inserting ‘‘sections 601 (other than 
subsection (g)), 602 (other than subsection (d))’’. 
(2) 
PAYMENT.—Paragraph 
(4) 
of 
section 
1844(a) of such Act (42 U.S.C. 1395w(a)), as added
178 
by section 601(g)(2), is amended by striking ‘‘sec-
tion 601 (other than subsection (g))’’ and inserting 
‘‘sections 601 (other than subsection (g)), 602 
(other than subsection (d))’’. 
(e) REPORT; REGULATIONS.— 
(1) REPORT.—Not later than the date that is 
3 years after the date of the enactment of this Act, 
the Inspector General of the Department of Health 
and Human Services shall conduct a study to assess 
(and submit to the Secretary of Health and Human 
Services a report on) any program integrity or over-
utilization risks with respect to allowing qualified 
audiologists (as defined in paragraph (4)(B) of 
1861(ll) of the Social Security Act (42 U.S.C. 
1395x(ll))) to furnish audiology services (as defined 
in paragraph (3) of such section) to individuals enti-
tled to benefits under part A of title XVIII of such 
Act (42 U.S.C. 1395c et seq.) and enrolled for bene-
fits under part B of such title (42 U.S.C.1395j et 
seq.) without such individuals being referred by a 
physician (as defined in section 1861(r) of such Act 
(42 U.S.C. 1395x(r))) or practitioner (as described 
in section 602.32 of title 42, Code of Federal Regu-
lations) to such qualified audiologists. In conducting 
such study, the Inspector General may take into ac-
179 
count experiences with audiologists furnishing audi-
ology services to enrollees in other Federal pro-
grams, including in a health benefit plan under 
chapter 89 of title 5, United States Code or in 
health care benefits under the TRICARE program 
under chapter 55 of title 10 of the United States 
Code or under chapter 17 of title 38 of such Code. 
(2) REGULATIONS.—The Secretary of Health 
and Human Services may promulgate regulations to 
allow qualified audiologists (as so defined) to furnish 
audiology services (as so defined) without a referral 
from a physician or practitioner, consistent with the 
findings submitted to the Secretary pursuant to 
paragraph (1)(B). 
(f) IMPLEMENTATION FUNDING.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this subsection referred to as 
the ‘‘Secretary’’) shall provide for the transfer from 
the Federal Supplementary Medical Insurance Trust 
Fund under section 1841 of the Social Security Act 
(42 U.S.C. 1395t) to the Centers for Medicare & 
Medicaid Services Program Management Account 
of— 
(A) $20,000,000 for each of fiscal years 
2020 through 2024 for purposes of imple-
180 
menting the amendments made by this section; 
and 
(B) such sums as determined appropriate 
by the Secretary for each subsequent fiscal year 
for purposes of administering the provisions of 
such amendments. 
(2) AVAILABILITY
AND
ADDITIONAL
USE
OF 
FUNDS.—Funds transferred pursuant to paragraph 
(1) shall remain available until expended and may be 
used, in addition to the purpose specified in para-
graph (1)(A), to implement the amendments made 
by sections 601 and 603. 
SEC. 603. PROVIDING COVERAGE FOR VISION CARE UNDER 
THE MEDICARE PROGRAM. 
(a) COVERAGE.—Section 1861(s)(2) of the Social Se-
curity Act (42 U.S.C. 1395x(s)(2)), as amended by section 
601(a), is further amended— 
(1) in subparagraph (HH), by striking ‘‘and’’ 
after the semicolon at the end; 
(2) in subparagraph (II), by striking the period 
at the end and adding ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(JJ) vision services (as defined in subsection 
(lll));’’.
181 
(b) VISION SERVICES DEFINED.—Section 1861 of 
the Social Security Act (42 U.S.C. 1395x), as amended 
by section 601(b), is further amended by adding at the 
end the following new subsection: 
‘‘(lll) VISION SERVICES.—The term ‘vision services’ 
means— 
‘‘(1) routine eye examinations to determine the 
refractive state of the eyes, including procedures per-
formed during the course of such examination; and 
‘‘(2) contact lens fitting services; 
furnished on or after January 1, 2023, by or under the 
direct supervision of an optometrist or ophthalmologist 
who is legally authorized to furnish such examinations, 
procedures, or fitting services (as applicable) under State 
law (or the State regulatory mechanism provided by State 
law) of the State in which the examinations, procedures, 
or fitting services are furnished.’’. 
(c) PAYMENT LIMITATIONS.—Section 1834 of the 
Social Security Act (42 U.S.C. 1395m), as amended by 
section 601(c)(2), is further amended by adding at the end 
the following new subsection: 
‘‘(y) LIMITATION FOR VISION SERVICES.—With re-
spect to vision services (as defined in section 1861(lll)) 
and an individual, payment may be made under this part 
for only 1 routine eye examination described in paragraph
182 
(1) of such section and 1 contact lens fitting service de-
scribed in paragraph (2) of such section during a 2-year 
period.’’. 
(d) PAYMENT UNDER PHYSICIAN FEE SCHEDULE.— 
Section 1848(j)(3) of the Social Security Act (42 U.S.C. 
1395w–4(j)(3)), as amended by section 601(d)(1), is fur-
ther amended by inserting ‘‘(2)(JJ),’’ before ‘‘(3)’’. 
(e) COVERAGE OF CONVENTIONAL EYEGLASSES AND 
CONTACT LENSES.—Section 1861(s)(8) of the Social Se-
curity Act (42 U.S.C. 1395x(s)(8)), as amended by section 
602(b)(1), is further amended by striking ‘‘, and including 
one pair of conventional eyeglasses or contact lenses fur-
nished subsequent to each cataract surgery with insertion 
of an intraocular lens’’ and inserting ‘‘, including one pair 
of conventional eyeglasses or contact lenses furnished sub-
sequent to each cataract surgery with insertion of an 
intraocular lens, if furnished before January 1, 2023, in-
cluding conventional eyeglasses or contact lenses, whether 
or not furnished subsequent to such a surgery, if furnished 
on or after January 1, 2024’’. 
(f) SPECIAL PAYMENT RULES FOR EYEGLASSES AND 
CONTACT LENSES.— 
(1) LIMITATIONS.—Section 1834(h) of the So-
cial Security Act (42 U.S.C. 1395m(h)), as amended 
by section 601(e)(2)(A) and section 602(b)(2), is
183 
further amended by adding at the end the following 
new paragraph: 
‘‘(8) PAYMENT LIMITATIONS FOR EYEGLASSES 
AND CONTACT LENSES.— 
‘‘(A) IN GENERAL.—With respect to eye-
glasses and contact lenses furnished to an indi-
vidual on or after January 1, 2023, subject to 
subparagraph (B), payment may be made under 
this part only— 
‘‘(i) during a 2-year period, for either 
1 pair of eyeglasses (including lenses and 
frames) or not more than a 2-year supply 
of contact lenses that is provided in not 
more than 180-day increments; 
‘‘(ii) with respect to amounts attrib-
utable to the lenses and frames of such a 
pair of eyeglasses or amounts attributable 
to such a 2-year supply of contact lenses, 
in an amount not greater than— 
‘‘(I) for a pair of eyeglasses fur-
nished in, or a 2-year supply of con-
tact lenses beginning in, 2023— 
‘‘(aa) $85 for the lenses of 
such pair of eyeglasses and $85
184 
for the frames of such pair of 
eyeglasses; or 
‘‘(bb) $85 for such 2-year 
supply of contact lenses; and 
‘‘(II) for the lenses and frames of 
a pair of eyeglasses furnished in, or a 
2-year supply of contact lenses begin-
ning in, a subsequent year, the dollar 
amounts specified under this subpara-
graph for the previous year, increased 
by the percentage change in the con-
sumer price index for all urban con-
sumers (United States city average) 
for the 12-month period ending with 
June of the previous year; 
‘‘(iii) for types of eyeglass lenses, and 
for types of contact lenses, as determined 
appropriate by the Secretary; 
‘‘(iv) if furnished pursuant to a writ-
ten order of a physician described in sec-
tion 1861(lll); and 
‘‘(v) if during the 2-year period de-
scribed in clause (i), the individual did not 
already receive (as described in subpara-
graph (B)) one pair of conventional eye-
185 
glasses or contact lenses subsequent to a 
cataract surgery with insertion of an intra-
ocular lens furnished during such period. 
‘‘(B) EXCEPTION.—With respect to a 2- 
year period described in subparagraph (A)(i), in 
the case of an individual who receives cataract 
surgery with insertion of an intraocular lens, 
notwithstanding subparagraph (A), payment 
may be made under this part for one pair of 
conventional eyeglasses or contact lenses fur-
nished subsequent to such cataract surgery dur-
ing such period.’’. 
(2) APPLICATION
OF
COMPETITIVE
ACQUISI-
TION.— 
(A) IN GENERAL.—Section 1834(h)(1)(H) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395m(h)(1)(H)), 
as 
amended 
by 
section 
601(e)(2)(B)(i) and section 602(b)(3)(A), is 
further amended— 
(i) in the header by inserting ‘‘, EYE-
GLASSES, AND
CONTACT
LENSES’’ after 
‘‘HEARING AIDS’’; 
(ii) by inserting ‘‘and of eyeglasses 
and contact lenses described in paragraph
186 
(2)(F) of such section,’’ after ‘‘paragraph 
(2)(E) of such section,’’; and 
(iii) in clause (i), by inserting ‘‘, or 
such eyeglasses and contact lenses’’ after 
‘‘such hearing aids’’. 
(B) CONFORMING AMENDMENT.— 
(i) IN GENERAL.—Section 1847(a)(2) 
of the Social Security Act (42 U.S.C. 
1395w–3(a)(2)), as amended by section 
601(e)(2)(B)(ii) 
and 
section 
602(b)(3)(B)(i), is further amended by 
adding at the end the following new sub-
paragraph: 
‘‘(F) 
EYEGLASSES
AND
CONTACT 
LENSES.—Eyeglasses and contact lenses de-
scribed in section 1861(s)(8) for which payment 
would 
otherwise 
be 
made 
under 
section 
1834(h).’’. 
(ii) EXEMPTION
OF
CERTAIN
ITEMS 
FROM
COMPETITIVE
ACQUISITION.—Sec-
tion 1847(a)(7) of the Social Security Act 
(42 U.S.C. 1395w–3(a)(7)), as amended 
by section 601(e)(2)(B)(iii) and section 
602(b)(3)(B)(ii), is further amended by
187 
adding at the end the following new sub-
paragraph: 
‘‘(E) CERTAIN EYEGLASSES AND CONTACT 
LENSES.—Those items and services described in 
paragraph (2)(F) if furnished by a physician or 
other practitioner (as defined by the Secretary) 
to the physician’s or practitioner’s own patients 
as part of the physician’s or practitioner’s pro-
fessional service.’’. 
(g) EXCLUSION MODIFICATIONS.—Section 1862(a) 
of the Social Security Act (42 U.S.C. 1395y(a)), as 
amended by section 601(f), is further amended— 
(1) in paragraph (1)— 
(A) in subparagraph (P), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (Q), by striking the 
semicolon at the end and inserting ‘‘, and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(R) in the case of vision services (as defined 
in section 1861(lll)) that are routine eye examina-
tions and contact lens fitting services (as described 
in paragraph (1) or (2), respectively, of such sec-
tion), which are furnished more frequently than once 
during a 2-year period;’’; and
188 
(2) in paragraph (7)— 
(A) by inserting ‘‘(other than such an ex-
amination that is a vision service that is cov-
ered under section 1861(s)(2)(JJ))’’ after ‘‘eye 
examinations’’; and 
(B) by inserting ‘‘(other than such a proce-
dure that is a vision service that is covered 
under section 1861(s)(2)(JJ))’’ after ‘‘refractive 
state of the eyes’’. 
(h) CERTAIN NON-APPLICATION.— 
(1) IN GENERAL.—The last sentence of section 
1839(a)(1) of the Social Security Act (42 U.S.C. 
1395r(a)(1)), as added by section 601(g)(1) and 
amended by section 602(d)(1), is further amended 
by inserting ‘‘, and 603 (other than subsection (h))’’ 
after ‘‘602 (other than subsection (d))’’. 
(2) 
PAYMENT.—Paragraph 
(4) 
of 
section 
1844(a) of such Act (42 U.S.C. 1395w(a)), as added 
by section 601(g)(2) and amended by section 
602(d)(2), is further amended by inserting ‘‘, and 
603 (other than subsection (h))’’ after ‘‘602 (other 
than subsection (d))’’. 
(i) IMPLEMENTATION FUNDING.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this subsection referred to as
189 
the ‘‘Secretary’’) shall provide for the transfer from 
the Federal Supplementary Medical Insurance Trust 
Fund under section 1841 of the Social Security Act 
(42 U.S.C. 1395t) to the Centers for Medicare & 
Medicaid Services Program Management Account 
of— 
(A) $20,000,000 for each of fiscal years 
2020 through 2024 for purposes of imple-
menting the amendments made by this section; 
and 
(B) such sums as determined appropriate 
by the Secretary for each subsequent fiscal year 
for purposes of administering the provisions of 
such amendments. 
(2) AVAILABILITY
AND
ADDITIONAL
USE
OF 
FUNDS.—Funds transferred pursuant to paragraph 
(1) shall remain available until expended and may be 
used, in addition to the purpose specified in para-
graph (1)(A), to implement the amendments made 
by sections 601 and 602.
190 
TITLE VII—NIH, FDA, AND 
OPIOIDS FUNDING 
Subtitle A—Biomedical Innovation 
Expansion 
SEC. 701. NIH INNOVATION INITIATIVES. 
(a) NIH INNOVATION ACCOUNT.— 
(1) IN GENERAL.—Section 1001(b) of the 21st 
Century Cures Act (Public Law 114–255) is amend-
ed by adding at the end the following: 
‘‘(5) SUPPLEMENTAL
FUNDING
AND
ADDI-
TIONAL ACTIVITIES.— 
‘‘(A) IN
GENERAL.—In addition to the 
funds made available under paragraph (2), 
there are authorized to be appropriated, and 
are hereby appropriated, to the Account, out of 
any monies in the Treasury not otherwise ap-
propriated, to be available until expended with-
out further appropriation, the following: 
‘‘(i) 
For 
fiscal 
year 
2021, 
$255,400,000. 
‘‘(ii) 
For 
fiscal 
year 
2022, 
$260,400,000. 
‘‘(iii) 
For 
fiscal 
year 
2023, 
$163,400,000.
191 
‘‘(iv) 
For 
fiscal 
year 
2024, 
$547,000,000. 
‘‘(v) 
For 
fiscal 
year 
2025, 
$848,000,000. 
‘‘(vi) 
For 
fiscal 
year 
2026, 
$842,400,000. 
‘‘(vii) 
For 
fiscal 
year 
2027, 
$1,089,600,000. 
‘‘(viii) 
For 
fiscal 
year 
2028, 
$1,115,600,000. 
‘‘(ix) 
For 
fiscal 
year 
2029, 
$1,170,600,000. 
‘‘(x) 
For 
fiscal 
year 
2030, 
$1,207,600,000. 
‘‘(B) SUPPLEMENTAL FUNDING FOR CER-
TAIN PROJECTS.—Of the total amounts made 
available under subparagraph (A) for each of 
fiscal years 2021 through 2030, a total amount 
not to exceed the following shall be made avail-
able for the following categories of NIH Innova-
tion Projects: 
‘‘(i) For projects described in para-
graph (4)(A), an amount not to exceed a 
total of $2,070,600,000 as follows:
192 
‘‘(I) For each of fiscal years 
2021 and 2022, $50,000,000. 
‘‘(II) 
For 
fiscal 
year 
2024, 
$100,000,000. 
‘‘(III) For each of fiscal years 
2025 and 2026, $300,000,000. 
‘‘(IV) For each of fiscal years 
2027 through 2029, $317,000,000. 
‘‘(V) 
For 
fiscal 
year 
2030, 
$319,600,000. 
‘‘(ii) For projects described in para-
graph (4)(B), an amount not to exceed a 
total of $2,041,900,000 as follows: 
‘‘(I) For each of fiscal years 
2021 and 2022, $50,000,000. 
‘‘(II) 
For 
fiscal 
year 
2024, 
$128,000,000. 
‘‘(III) For fiscal year 2025, 
$209,000,000. 
‘‘(IV) For fiscal year 2026, 
$100,000,000. 
‘‘(V) 
For 
fiscal 
year 
2027, 
$325,000,000. 
‘‘(VI) For fiscal year 2028, 
$350,000,000.
193 
‘‘(VII) For fiscal year 2029, 
$400,000,000. 
‘‘(VIII) For fiscal year 2030, 
$429,900,000. 
‘‘(iii) For projects described in para-
graph (4)(C), an amount not to exceed a 
total of $1,558,400,000 as follows: 
‘‘(I) For each of fiscal years 
2024 and 2025, $151,200,000. 
‘‘(II) For each of fiscal years 
2026 through 2030, $251,200,000. 
‘‘(iv) For projects described in para-
graph (4)(D), an amount not to exceed 
$15,400,000 for each of fiscal years 2021 
through 2030. 
‘‘(C) 
ADDITIONAL
NIH
INNOVATION 
PROJECTS.—In addition to funding NIH Inno-
vation Projects pursuant to subparagraph (B), 
of the total amounts made available under sub-
paragraph (A), a total amount not to exceed 
the following shall be made available for the fol-
lowing categories of NIH Innovation Projects: 
‘‘(i) To support research related to 
combating antimicrobial resistance and an-
tibiotic resistant bacteria, including re-
194 
search into new treatments, diagnostics, 
and vaccines, research, in consultation with 
the Centers for Disease Control and Pre-
vention, into stewardship, and the develop-
ment of strategies, in coordination with the 
Biomedical Advanced Research and Devel-
opment Authority under section 319L of 
the Public Health Service Act, to support 
commercialization of new antibiotics, not 
to exceed a total of 1,144,500,000, as fol-
lows: 
‘‘(I) For each of fiscal years 
2021 through 2024, $100,000,000. 
‘‘(II) For each of fiscal years 
2025 and 2026, $120,000,000. 
‘‘(III) For each of fiscal years 
2027 through 2029, $125,000,000. 
‘‘(IV) For fiscal year 2030, 
$129,500,000. 
‘‘(ii) To support research and re-
search activities related to rare diseases or 
conditions, including studies or analyses 
that help to better understand the natural 
history of a rare disease or condition and 
translational studies related to rare dis-
195 
eases or conditions, not to exceed a total of 
$530,600,000, as follows: 
‘‘(I) 
For 
fiscal 
year 
2021, 
$40,000,000. 
‘‘(II) 
For 
fiscal 
year 
2022, 
$45,000,000. 
‘‘(III) For fiscal year 2023, 
$48,000,000. 
‘‘(IV) For each of fiscal years 
2024 and 2025, $52,400,000. 
‘‘(V) 
For 
fiscal 
year 
2026, 
$55,800,000. 
‘‘(VI) For fiscal year 2027, 
$56,000,000. 
‘‘(VII) For fiscal year 2028, 
$57,000,000. 
‘‘(VIII) For each of fiscal years 
2029 and 2030, $62,000,000.’’. 
(2) CONFORMING AMENDMENTS.—Section 1001 
of the 21st Century Cures Act (Public Law 114– 
255) is amended— 
(A) in subsection (a), by striking ‘‘sub-
section (b)(4)’’ and inserting ‘‘subsections 
(b)(4) and (b)(5)’’;
197 
‘‘September 30, 2026’’ and inserting ‘‘September 30, 
2030’’. 
SEC. 702. NIH CLINICAL TRIAL. 
Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIA-
TIVE. 
‘‘(a) ESTABLISHMENT
OF PILOT PROGRAM.—The 
Secretary, acting through the Director of the National In-
stitutes of Health, shall, not later than 2 years after the 
date of enactment of this Act, establish and implement 
a pilot program to award multi-year contracts to eligible 
entities to support phase II clinical trials and phase III 
clinical trials— 
‘‘(1) to promote innovation in treatments and 
technologies supporting the advanced research and 
development and production of high need cures; and 
‘‘(2) to provide support for the development of 
medical products and therapies. 
‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 
assistance under the pilot program established under sub-
section (a), an entity shall—
198 
‘‘(1) be seeking to market a medical product or 
therapy that is the subject of clinical trial or trials 
to be supported using such assistance; 
‘‘(2) be a public or private entity, which may 
include a private or public research institution, a 
contract research organization, an institution of 
higher education (as defined in section 101 of the 
Higher Education Act of 1965 (20 U.S.C. 1001)), a 
medical center, a biotechnology company, or an aca-
demic research institution; and 
‘‘(3) comply with requirements of the Federal 
Food, Drug, and Cosmetic Act or section 351 of this 
Act at all stages of development, manufacturing, re-
view, approval, and safety surveillance of a medical 
product. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of National Institutes of Health, shall— 
‘‘(1) in establishing the pilot program under 
subsection (a), consult with— 
‘‘(A) the Director of the National Center 
for Advancing Translational Sciences and the 
other national research institutes in considering 
their requests for new or expanded clinical trial 
support efforts; and
199 
‘‘(B) the Commissioner of Food and Drugs 
and any other head of a Federal agency as the 
Secretary determines to be appropriate to en-
sure coordination and efficiently advance clin-
ical trial activities; 
‘‘(2) in implementing the pilot program under 
subsection (a), consider consulting with patients and 
patient advocates; and 
‘‘(3) in awarding contracts under the pilot pro-
gram under subsection (a), consider— 
‘‘(A) the expected health impacts of the 
clinical trial or trials to be supported under the 
contract; and 
‘‘(B) the degree to which the medical prod-
uct or therapy that is the subject of such clin-
ical trial or trials is a high need cure. 
‘‘(d) EXCLUSION.—A contract may not be awarded 
under the pilot program under subsection (a) if the drug 
that is the subject of the clinical trial or trials to be sup-
ported under the contract is a drug designated under sec-
tion 526 of the Federal Food, Drug, and Cosmetic Act 
as a drug for a rare disease or condition. 
‘‘(e) NIH CLINICAL
TRIAL
ACCELERATOR
AC-
COUNT.—
200 
‘‘(1) ESTABLISHMENT.—There is established in 
the Treasury an account, to be known as the ‘NIH 
Clinical Trial Accelerator Account’ (referred to in 
this section as the ‘Account’), for purposes of car-
rying out this section. 
‘‘(2) TRANSFER
OF
DIRECT
SPENDING
SAV-
INGS.—There shall be transferred to the Account 
from 
the 
general 
fund 
of 
the 
Treasury, 
$680,000,000 for each of fiscal years 2021 through 
2025, to be available until expended without further 
appropriation. 
‘‘(3) WORK PLAN.—Not later than 180 days 
after the date of enactment of this Act, the Sec-
retary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor and Pen-
sions of the Senate a work plan that includes the 
proposed implementation of this section and the pro-
posed allocation of funds in the Account. 
‘‘(f) REPORTS TO CONGRESS.—Not later than Octo-
ber 1 of each fiscal year, the Secretary shall submit to 
the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor and Pensions of the Senate a report on— 
‘‘(1) the implementation of this section;
201 
‘‘(2) any available results on phase II clinical 
trials and phase III clinical trials supported under 
this section during such fiscal year; and 
‘‘(3) the extent to which Federal funds are obli-
gated to support such clinical trials, including the 
specific amount of such support and awards pursu-
ant to an allocation from the Account under sub-
section (e). 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) PHASE
II
CLINICAL
TRIAL.—The term 
‘phase II clinical trial’ means a phase II clinical in-
vestigation, as described in section 312.21 of title 
21, Code of Federal Regulations (or any successor 
regulations). 
‘‘(2) PHASE III CLINICAL TRIALS.—The term 
‘phase III clinical trial’ means a phase III clinical 
investigation, as described in section 312.21 of title 
21, Code of Federal Regulations (or any successor 
regulations). 
‘‘(3) HIGH NEED CURE.—The term ‘high need 
cure’ has the meaning given such term in section 
480(a)(3).’’.
202 
SEC. 703. INNOVATION NETWORK. 
Part A of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.), as amended by section 702, is 
further amended by adding at the end the following: 
‘‘SEC. 404P. INNOVATION NETWORK. 
‘‘(a) FUNDS.—The Director of NIH shall award 
grants or contracts to eligible entities to develop, expand, 
and enhance the commercialization of biomedical products. 
‘‘(b) ELIGIBLE ENTITY.—In this section, the term 
‘eligible entity’ means an entity receiving funding under— 
‘‘(1) the Small Business Innovation Research 
program of the National Institutes of Health; or 
‘‘(2) the Small Business Technology Transfer 
program of the National Institutes of Health. 
‘‘(c) USE OF FUNDS.—An eligible entity shall use the 
funds received through such grant or contract to sup-
port— 
‘‘(1) the Commercialization Readiness Pilot 
program of the National Institutes of Health; 
‘‘(2) the Innovation Corps program of the Na-
tional Institutes of Health; 
‘‘(3) the Commercialization Accelerator pro-
gram of the National Institutes of Health; 
‘‘(4) the Commercialization Assistance program 
of the National Institutes of Health; and
203 
‘‘(5) such other programs and activities as the 
Director of NIH determines to be appropriate, to 
support the commercialization stage of research, 
later stage research and development, technology 
transfer, and commercialization technical assistance. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$100,000,000 for each of fiscal years 2021 through 2025, 
to be available until expended.’’. 
Subtitle B—Investing in Safety and 
Innovation 
SEC. 711. FOOD AND DRUG ADMINISTRATION. 
(a) FDA INNOVATION ACCOUNT.— 
(1) IN GENERAL.—Section 1002(b) of the 21st 
Century Cures Act (Public Law 114–255) is amend-
ed— 
(A) in paragraph (1), by striking ‘‘para-
graph (4)’’ and inserting ‘‘paragraphs (4) and 
(5)’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(5) SUPPLEMENTAL
FUNDING
AND
ADDI-
TIONAL ACTIVITIES.— 
‘‘(A) IN
GENERAL.—In addition to the 
funds made available under paragraph (2),
204 
there are authorized to be appropriated, and 
are hereby appropriated, to the Account, out of 
any monies in the Treasury not otherwise ap-
propriated, to be available until expended with-
out further appropriation, the following: 
‘‘(i) 
For 
fiscal 
year 
2020, 
$417,500,000. 
‘‘(ii) For each of fiscal years 2021 
and 2022, $157,500,000. 
‘‘(iii) For each of fiscal years 2023 
through 2025, $152,500,000. 
‘‘(iv) For each of fiscal years 2026 
through 2029, $202,500,000. 
‘‘(B) SUPPLEMENTAL FUNDING FOR CER-
TAIN ACTIVITIES.—Of the total amounts made 
available under subparagraph (A) for each of 
fiscal years 2026 through 2029, a total amount 
not to exceed $50,000,000 for each such fiscal 
year, shall be made available for the activities 
under subtitles A through F (including the 
amendments made by such subtitles) of title III 
of this Act and section 1014 of the Federal 
Food, Drug, and Cosmetic Act, as added by 
section 3073 of this Act.
205 
‘‘(C) ADDITIONAL
FDA
ACTIVITIES.—In 
addition to funding activities pursuant to sub-
paragraph (B), of the total amounts made 
available under subparagraph (A), a total 
amount not to exceed the following shall be 
made available for the following categories of 
activities: 
‘‘(i) For modernization of the tech-
nical infrastructure of the Food and Drug 
Administration, including enhancements 
such as interoperability across the agency, 
and additional capabilities to develop an 
advanced information technology infra-
structure to support the agency’s regu-
latory mission: 
‘‘(I) 
For 
fiscal 
year 
2020, 
$180,000,000. 
‘‘(II) For each of fiscal years 
2021 through 2029, $60,000. 
‘‘(ii) For support for continuous man-
ufacturing of drugs and biological prod-
ucts, including complex biological products 
such as regenerative medicine therapies, 
through grants to institutions of higher 
education and nonprofit organizations and
206 
other appropriate mechanisms, for each of 
fiscal 
years 
2020 
through 
2029, 
$20,000,000. 
‘‘(iii) For support for the Commis-
sioner of Food and Drugs to engage ex-
perts, such as through the formation and 
operation of public-private partnerships or 
other appropriate collaborative efforts, to 
advance the development and delivery of 
individualized human gene therapy prod-
ucts: 
‘‘(I) 
For 
fiscal 
year 
2020, 
$50,000,000. 
‘‘(II) For each of fiscal years 
2021 through 2029, $10,000,000. 
‘‘(iv) For support for inspections, en-
forcement, and quality surveillance activi-
ties across the Food and Drug Administra-
tion, including foreign and domestic in-
spections across products, for each of fiscal 
years 2020 through 2029, $20,000,000. 
‘‘(v) For support for activities of the 
Food and Drug Administration related to 
customs and border protection to provide 
improvements to technologies, inspection
207 
capacity, and sites of import (including 
international mail facilities) in which the 
Food and Drug Administration operates, 
for each of fiscal years 2020 through 
2029, $10,000,000. 
‘‘(vi) To further advance the develop-
ment of a coordinated postmarket surveil-
lance system for all medical products, in-
cluding drugs, biological products, and de-
vices, linked to electronic health records in 
furtherance of the Food and Drug Admin-
istration’s postmarket surveillance capabili-
ties: 
‘‘(I) 
For 
fiscal 
year 
2020, 
$112,500,000. 
‘‘(II) For each of fiscal years 
2021 through 2029, $12,500,000. 
‘‘(vii) For support for Food and Drug 
Administration activities to keep pace with 
the projected product development of re-
generative therapies, including cellular and 
somatic cell gene therapy products: 
‘‘(I) For each of fiscal years 
2020 through 2022, $10,000,000.
208 
‘‘(II) For each of fiscal years 
2023 through 2029, $5,000,000. 
‘‘(viii) For carrying out section 714A 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379d–3a; relating to hiring 
authority for scientific, technical, and pro-
fessional personnel), for each of fiscal 
years 2020 through 2029, $2,500,000. 
‘‘(ix) For the Food and Drug Admin-
istration to support improvements to the 
technological infrastructure for reporting 
and analysis of adverse events associated 
with the use of drugs and biological prod-
ucts, for each of fiscal years 2020 through 
2029, $12,500,000.’’. 
(2) CONFORMING AMENDMENTS.—Section 1002 
of the 21st Century Cures Act (Public Law 114– 
255) is amended— 
(A) in subsection (a), by inserting before 
the period at the end the following: ‘‘or pursu-
ant to subparagraph (A) of subsection (b)(5) to 
carry out the activities described in subpara-
graphs (B) and (C) of such subsection’’; and 
(B) in subsection (d)—
209 
(i) by inserting ‘‘or pursuant to sub-
paragraph (A) of subsection (b)(5)’’ after 
‘‘subsection (b)(3)’’; and 
(ii) by striking ‘‘subsection (b)(4)’’ 
and inserting ‘‘subsections (b)(4) and 
(b)(5)’’. 
(b) ANNUAL REPORT.—Section 1002(c)(2)(A) of the 
21st Century Cures Act (Public Law 114–255) is amend-
ed, in the matter preceding clause (i), by striking ‘‘2026’’ 
and inserting ‘‘2030’’. 
(c) SUNSET.—Section 1002(e) of the 21st Century 
Cures Act (Public Law 114–255) is amended by striking 
‘‘September 30, 2025’’ and inserting ‘‘September 30, 
2030’’. 
SEC. 712. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS. 
(a) IN GENERAL.—Not later than 180 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall conduct a study to identify— 
(1) diseases or conditions that lack a treatment 
approved by the Food and Drug Administration and 
instances in which development of a treatment for 
such diseases or conditions could fill an unmet med-
ical need for the treatment of a serious or life- 
threatening disease or condition or a rare disease or 
condition; and
210 
(2) appropriate incentives that would lead to 
the development, approval, and marketing of such 
treatments. 
(b) REPORT TO CONGRESS; RECOMMENDATIONS.— 
Not later than one year after the date of enactment of 
this Act, the Secretary shall submit to the Congress a re-
port that includes— 
(1) findings from the study under subsection 
(a); and 
(2) recommendations regarding legislation nec-
essary to create appropriate incentives identified 
pursuant to subsection (a)(2). 
Subtitle C—Opioid Epidemic 
Response 
SEC. 721. OPIOID EPIDEMIC RESPONSE FUND. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall use any funds made available pursuant to 
subsection (b) to carry out the programs and activities de-
scribed in subsection (c) to address the opioid and sub-
stance use disorder epidemic. Such funds shall be in addi-
tion to any funds which are otherwise available to carry 
out such programs and activities. 
(b) OPIOID EPIDEMIC RESPONSE FUND.—
211 
(1) ESTABLISHMENT OF ACCOUNT.—There is 
established in the Treasury an account, to be known 
as the Opioid Epidemic Response Fund (referred to 
in this section as the ‘‘Fund’’), for purposes of fund-
ing the programs and activities described in sub-
section (c). 
(2) FUNDING.—There is authorized to be ap-
propriated, and there is appropriated, to the Fund, 
out of any monies in the Treasury not otherwise ap-
propriated $1,980,000,000 for each of fiscal years 
2021 through 2025. 
(3) AVAILABILITY.—Amounts made available by 
paragraph (2) shall be made available to the agen-
cies specified in subsection (c) in accordance with 
such subsection. Amounts made available to an 
agency pursuant to the preceding sentence for a fis-
cal year shall remain available until expended. 
(c) PROGRAMS
AND
ACTIVITIES.—Of the total 
amount in the Fund for each of fiscal years 2021 through 
2025, such amount shall be allocated as follows: 
(1) SAMHSA.—For the Substance Abuse and 
Mental Health Services Administration to carry out 
programs and activities pursuant to section 722, 
$1,500,000,000 for each of fiscal years 2021 
through 2025.
212 
(2) CDC.—For the Centers for Disease Control 
and Prevention to carry out programs and activities 
pursuant to section 723, $120,000,000 for each of 
fiscal years 2021 through 2025. 
(3) FDA.—For the Food and Drug Adminis-
tration to carry out programs and activities pursu-
ant to section 724, $10,000,000 for each of fiscal 
years 2021 through 2025. 
(4) NIH.—For the National Institutes of 
Health to carry out programs and activities pursu-
ant to section 725, $240,000,000 for each of fiscal 
years 2021 through 2025. 
(5) HRSA.—For the Health Resources and 
Services Administration to carry out programs and 
activities pursuant to section 726, $90,000,000 for 
each of fiscal years 2021 through 2025. 
(6) ACF.—For the Administration for Children 
and Families to carry out programs and activities 
pursuant to section 727, $20,000,000 for each of 
fiscal years 2021 through 2025. 
(d) ACCOUNTABILITY AND OVERSIGHT.— 
(1) WORK PLAN.— 
(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this Act, 
the Secretary of Health and Human Services
213 
shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions and the Committee 
on Appropriations of the Senate and the Com-
mittee on Energy and Commerce, the Com-
mittee on Appropriations, and the Committee 
on Education and Labor of the House of Rep-
resentatives, a work plan including the proposed 
allocation of funds made available pursuant to 
subsection (b) for each of fiscal years 2021 
through 2025 and the contents described in 
subparagraph (B). 
(B) CONTENTS.—The work plan submitted 
under subparagraph (A) shall include— 
(i) the amount of money to be obli-
gated or expended out of the Fund in each 
fiscal year for each program and activity 
described in subsection (c); and 
(ii) a description and justification of 
each such program and activity. 
(2) ANNUAL REPORTS.—Not later than October 
1 of each of fiscal years 2022 through 2026, the 
Secretary of Health and Human Services shall sub-
mit to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations 
of the Senate and the Committee on Energy and
214 
Commerce, the Committee on Appropriations, and 
the Committee on Education and Labor of the 
House of Representatives, a report including— 
(A) the amount of money obligated or ex-
pended out of the Fund in the prior fiscal year 
for each program and activity described in sub-
section (c); 
(B) a description of all programs and ac-
tivities using funds made available pursuant to 
subsection (b); and 
(C) how the programs and activities are re-
sponding to the opioid and substance use dis-
order epidemic. 
(e) LIMITATIONS.—Notwithstanding any authority in 
this subtitle or any appropriations Act, any funds made 
available pursuant to subsection (b) may not be used for 
any purpose other than the programs and activities de-
scribed in subsection (c). 
SEC. 722. SUBSTANCE ABUSE AND MENTAL HEALTH SERV-
ICES ADMINISTRATION. 
(a) IN GENERAL.—The entirety of the funds made 
available pursuant to section 721(c)(1) shall be for the As-
sistant Secretary for Mental Health and Substance Use 
to continue to award the State Opioid Response Grants 
funded by the heading ‘‘Substance Abuse And Mental
215 
Health Services Administration—Substance Abuse Treat-
ment’’ in title II of the Departments of Labor, Health and 
Human Services, and Education, and Related Agencies 
Appropriations Act, 2018 (Public Law 115–141). Subject 
to subsections (b) and (c), such grants shall be awarded 
in the same manner and subject to the same conditions 
as were applicable to such grants for fiscal year 2018. 
(b) REQUIREMENT
THAT
TREATMENT
BE
EVI-
DENCE-BASED.—As a condition on receipt of a grant pur-
suant to subsection (a), a grantee shall agree that— 
(1) treatments, practices, or interventions fund-
ed through the grant will be evidence-based; and 
(2) such treatments, practices, and interven-
tions will include medication-assisted treatment for 
individuals diagnosed with opioid use disorder, using 
drugs only if the drugs have been approved or li-
censed by the Food and Drug Administration under 
section 505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355) or section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(c) RESERVATIONS.—Of the amount made available 
pursuant to section 731(c)(1) for a fiscal year— 
(1) not less than $75,000,000 shall be reserved 
to make grants under subsection (a) to Indian 
Tribes or Tribal organizations; and
216 
(2) not less than $50,000,000 shall be reserved 
to make grants under subsection (a) to political sub-
divisions of States, such as counties, cities, or towns. 
SEC. 723. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION. 
(a) ADDRESSING OPIOID USE DISORDER.—The en-
tirety of the funds made available pursuant to section 
721(c)(2) shall be for the Director of the Centers for Dis-
ease Control and Prevention, pursuant to applicable au-
thorities in the Public Health Service Act (42 U.S.C. 201 
et seq.), to continue and expand programs of the Centers 
for Disease Control and Prevention to address opioid and 
substance use disorder, including by— 
(1) improving the timeliness and quality of data 
on the opioid use disorder epidemic, including im-
provement of— 
(A) data on fatal and nonfatal overdoses; 
(B) syndromic surveillance; 
(C) data on long-term sequelae (including 
neonatal abstinence syndrome); and 
(D) cause of death reporting related to 
substance abuse or opioid overdose; 
(2) expanding and strengthening evidence-based 
prevention and education strategies;
217 
(3) supporting responsible prescribing practices, 
including through development and dissemination of 
prescriber guidelines; 
(4) improving access to and use of effective pre-
vention, treatment, and recovery support, including 
through grants and the provision of technical assist-
ance to States and localities; 
(5) strengthening partnerships with first re-
sponders, including to protect their safety; 
(6) considering the needs of vulnerable popu-
lations; 
(7) addressing infectious diseases linked to the 
opioid crisis; 
(8) strengthening prescription drug monitoring 
programs; and 
(9) providing financial and technical assistance 
to State and local health department efforts to treat 
and prevent substance use disorder. 
(b) LIMITATION.—Of the funds made available pur-
suant to section 721(c)(2) for carrying out this section, 
not more than 20 percent may be used for intramural pur-
poses. 
SEC. 724. FOOD AND DRUG ADMINISTRATION. 
The entirety of the funds made available pursuant to 
section 721(c)(3) shall be for the Commissioner of Food
218 
and Drugs, pursuant to applicable authorities in the Pub-
lic Health Service Act (42 U.S.C. 201 et seq.) or the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) and other applicable law, to support widespread inno-
vation in non-opioid and non-addictive medical products 
for pain treatment, access to opioid addiction treatments, 
appropriate use of approved opioids, and efforts to reduce 
illicit importation of opioids. Such support may include the 
following: 
(1) Facilitating the development of non-opioid 
and non-addictive pain treatments. 
(2) Advancing guidance documents for sponsors 
of non-opioid pain products. 
(3) Developing evidence to inform the potential 
for nonprescription overdose therapies. 
(4) Examining expanded labeling indications for 
medication-assisted treatment. 
(5) Conducting public education and outreach, 
including public workshops or public meetings, re-
garding the benefits of medication-assisted treat-
ment, including all drugs approved by the Food and 
Drug Administration, and device treatment options 
approved or cleared by the Food and Drug Adminis-
tration.
219 
(6) Exploring the expansion and possible man-
datory nature of prescriber education regarding pain 
management and appropriate opioid prescribing 
through authorities under section 505–1 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355– 
1). 
(7) Examining options to limit the duration of 
opioid prescriptions for acute pain, including 
through packaging options. 
(8) Increasing staff and infrastructure capacity 
to inspect and analyze packages at international 
mail facilities and pursue criminal investigations. 
SEC. 725. NATIONAL INSTITUTES OF HEALTH. 
The entirety of the funds made available pursuant to 
section 721(c)(4) shall be for the Director of the National 
Institutes of Health, pursuant to applicable authorities in 
the Public Health Service Act (42 U.S.C. 201 et seq.), 
to carry out activities related to— 
(1) accelerating research for addressing the 
opioid use disorder epidemic, including developing 
non-opioid medications and interventions, including 
non-addictive medications, to manage pain, as well 
as developing medications and interventions to treat 
and to prevent substance use disorders;
220 
(2) conducting and supporting research on 
which treatments (in terms of pain management as 
well as treating and preventing substance use dis-
orders) are optimal for which patients; and 
(3) conducting and supporting research on cre-
ating longer-lasting or faster-acting antidotes for 
opioid overdose, particularly in response to the prev-
alence of fentanyl and carfentanyl overdoses. 
SEC. 726. HEALTH RESOURCES AND SERVICES ADMINIS-
TRATION. 
The entirety of the funds made available pursuant to 
section 721(c)(5) shall be for the Administrator of the 
Health Resources and Services Administration, pursuant 
to applicable authorities in titles III, VII, and VIII of the 
Public Health Service Act (42 U.S.C. 241 et seq.), to 
carry out activities that increase the availability and ca-
pacity of the behavioral health workforce. Such activities 
shall include providing loan repayment assistance for sub-
stance use disorder treatment providers. 
SEC. 727. ADMINISTRATION FOR CHILDREN AND FAMILIES. 
Of the funds made available pursuant to section 
721(c)(6) for each of fiscal years 2021 through 2025, 
$20,000,000 for each such fiscal year shall be for the Sec-
retary of Health and Human Services to carry out title
221 
I of the Child Abuse Prevention and Treatment Act (42 
U.S.C. 5101 et seq.). 
Subtitle D—Reducing Administra-
tive 
Costs 
and 
Burdens 
in 
Health Care 
SEC. 731. REDUCING ADMINISTRATIVE COSTS AND BUR-
DENS IN HEALTH CARE. 
Title II of the Public Health Service Act (42 U.S.C. 
202 et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART E—REDUCING ADMINISTRATIVE COSTS 
AND BURDENS IN HEALTH CARE 
‘‘SEC. 281. ELIMINATING UNNECESSARY ADMINISTRATIVE 
BURDENS AND COSTS. 
‘‘(a) REDUCING ADMINISTRATIVE BURDENS
AND 
COSTS.—The Secretary, in consultation with providers of 
health services, health care suppliers of services, health 
care payers, health professional societies, health vendors 
and developers, health care standard development organi-
zations and operating rule entities, health care quality or-
ganizations, health care accreditation organizations, public 
health entities, States, patients, and other appropriate en-
tities, shall, in accordance with subsection (b)— 
‘‘(1) establish a goal of reducing unnecessary 
costs and administrative burdens across the health
222 
care system, including the Medicare program under 
title XVIII of the Social Security Act, the Medicaid 
program under title XIX of such Act, and the pri-
vate health insurance market, by at least half over 
a period of 10 years from the date of enactment of 
this section; 
‘‘(2) develop strategies and benchmarks for 
meeting the goal established under paragraph (1); 
‘‘(3) develop recommendations for meeting the 
goal established under paragraph (1); and 
‘‘(4) take action to reduce unnecessary costs 
and administrative burdens based on recommenda-
tions identified in this subsection. 
‘‘(b) STRATEGIES, RECOMMENDATIONS, AND AC-
TIONS.— 
‘‘(1) IN GENERAL.—To achieve the goal estab-
lished under subsection (a)(1), the Secretary, in con-
sultation with the entities described in such sub-
section, shall not later than 1 year after the date of 
enactment of this section, develop strategies and rec-
ommendations and take actions to meet such goal in 
accordance with this subsection. No strategies, rec-
ommendation, or action shall undermine the quality 
of patient care or patient health outcomes.
223 
‘‘(2) STRATEGIES.—The strategies developed 
under paragraph (1) shall address unnecessary costs 
and administrative burdens. Such strategies shall in-
clude broad public comment and shall prioritize— 
‘‘(A) recommendations identified as a re-
sult of efforts undertaken to implement section 
3001; 
‘‘(B) recommendations and best practices 
identified as a result of efforts undertaken 
under this part; 
‘‘(C) a review of regulations, rules, and re-
quirements of the Department of Health and 
Human Services that could be modified or 
eliminated to reduce unnecessary costs and ad-
ministrative burden imposed on patients, pro-
viders, payers, and other stakeholders across 
the health care system; and 
‘‘(D) feedback from stakeholders in rural 
or frontier areas on how to reduce unnecessary 
costs and administrative burdens on the health 
care system in those areas. 
‘‘(3) RECOMMENDATIONS.—The recommenda-
tions developed under paragraph (1) shall include—
224 
‘‘(A) actions that improve the standardiza-
tion and automation of administrative trans-
actions; 
‘‘(B) actions that integrate clinical and ad-
ministrative functions; 
‘‘(C) actions that improve patient care and 
reduce unnecessary costs and administrative 
burdens borne by patients, their families, and 
other caretakers; 
‘‘(D) actions that advance the development 
and adoption of open application programming 
interfaces and other emerging technologies to 
increase transparency and interoperability, em-
power patients, and facilitate better integration 
of clinical and administrative functions; 
‘‘(E) actions to be taken by the Secretary 
and actions that need to be taken by other enti-
ties; and 
‘‘(F) other areas, as the Secretary deter-
mines appropriate, to reduce unnecessary costs 
and administrative burdens required of health 
care providers. 
‘‘(4) CONSISTENCY.—Any improvements in 
electronic processes proposed by the Secretary under 
this section should leverage existing information
225 
technology definitions under Federal Law. Specifi-
cally, any electronic processes should not be con-
strued to include a facsimile, a proprietary payer 
portal that does not meet standards specified by the 
Secretary, or an electronic form image. 
‘‘(5) ACTIONS.—The Secretary shall take action 
to achieve the goal established under subsection 
(a)(1), and, not later than 1 year after the date of 
enactment of this section, and biennially thereafter, 
submit to Congress and make publically available, a 
report describing the actions taken by the Secretary 
pursuant to goals, strategies, and recommendations 
described in this subsection. 
‘‘(6) FACA.—The Federal Advisory Committee 
Act (5 U.S.C. App.) shall not apply to the develop-
ment of the goal, strategies, recommendations, or 
actions described in this section. 
‘‘(7) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to authorize, or be 
used by, the Federal Government to inhibit or other-
wise restrain efforts made to reduce waste, fraud, 
and abuse across the health care system.
226 
‘‘SEC. 282. GRANTS TO STATES TO DEVELOP AND IMPLE-
MENT RECOMMENDATIONS TO ACCELERATE 
STATE INNOVATION TO REDUCE HEALTH 
CARE ADMINISTRATIVE COSTS. 
‘‘(a) GRANTS.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of enactment of this section, the Sec-
retary shall award grants to at least 15 States, and 
one coordinating entity designated as provided for 
under subsection (e), to enable such States to estab-
lish and administer private-public multi-stakeholder 
commissions for the purpose of reducing health care 
administrative costs and burden within and across 
States. Not less than 3 of such grants shall be 
awarded to States that are primarily rural, frontier, 
or a combination thereof, in nature. 
‘‘(2) ENTITIES.—For purposes of this section, 
the term ‘State’ means a State, a State designated 
entity, or a multi-State collaborative (as defined by 
the Secretary). 
‘‘(3) PRIORITY.—In awarding grants under this 
section, the Secretary shall give priority to applica-
tions submitted by States that propose to carry out 
a pilot program or support the adoption of electronic 
health care transactions and operating rules. 
‘‘(b) APPLICATION.—
227 
‘‘(1) IN GENERAL.—To be eligible to receive a 
grant under subsection (a) a State shall submit to 
the Secretary an application in such a manner and 
containing such information as the Secretary may 
reasonably require, including the information de-
scribed in paragraph (2). 
‘‘(2) REQUIRED INFORMATION.—In addition to 
any additional information required by the Secretary 
under this subsection, an application shall include a 
description of— 
‘‘(A) the size and composition of the com-
mission to be established under the grant, in-
cluding the stakeholders represented and the 
degree to which the commission reflects impor-
tant geographic and population characteristics 
of the State; 
‘‘(B) the relationship of the commission to 
the State official responsible for coordinating 
and implementing the recommendations result-
ing from the commission, and the role and re-
sponsibilities of the State with respect to the 
commission, including any participation, review, 
oversight, implementation or other related func-
tions;
228 
‘‘(C) the history and experience of the 
State in addressing health care administrative 
costs, and any experience similar to the purpose 
of the commission to improve health care ad-
ministrative processes and the exchange of 
health care administrative data; 
‘‘(D) the resources and expertise that will 
be made available to the commission by com-
mission members or other possible sources, and 
how Federal funds will be used to leverage and 
complement these resources; 
‘‘(E) the governance structure and proce-
dures that the commission will follow to make, 
implement, and pilot recommendations; 
‘‘(F) the proposed objectives relating to the 
simplification of administrative transactions 
and operating rules, increased standardization, 
and the efficiency and effectiveness of the 
transmission of health information; 
‘‘(G) potential cost savings and other im-
provements in meeting the objectives described 
in subparagraph (F); and 
‘‘(H) the method or methods by which the 
recommendations described in subsection (c)
229 
will be reviewed, tested, adopted, implemented, 
and updated as needed. 
‘‘(c) MULTI-STAKEHOLDER COMMISSION.— 
‘‘(1) IN
GENERAL.—Not later than 90 days 
after the date on which a grant is awarded to a 
State under this section, the State official described 
in subsection (b)(2)(B), the State insurance commis-
sioner, or other appropriate State official shall con-
vene a multi-stakeholder commission, in accordance 
with this subsection. 
‘‘(2) MEMBERSHIP.—The commission convened 
under paragraph (1) shall include representatives 
from health plans, health care providers, health ven-
dors, relevant State agencies, health care standard 
development organizations, and operating rule enti-
ties, relevant professional and trade associations, pa-
tients, and other entities determined appropriate by 
the State. 
‘‘(3) RECOMMENDATIONS.—Not later than one 
year after the date on which a grant is awarded to 
a State under this section, the commission shall 
make recommendations and plans, consistent with 
the application submitted by the State under sub-
section (b), and intended to meet the objectives de-
fined in the application. Such recommendations shall
230 
comply with, and build upon, all relevant Federal re-
quirements and regulations, and may include— 
‘‘(A) common, uniform specifications, best 
practices, and conventions, for the efficient, ef-
fective exchange of administrative transactions 
adopted pursuant to the Health Insurance Port-
ability and Accountability Act of 1996 (Public 
Law 104–191); 
‘‘(B) the development of streamlined busi-
ness processes for the exchange and use of 
health care administrative data; and 
‘‘(C) specifications, incentives, require-
ments, tools, mechanisms, and resources to im-
prove— 
‘‘(i) the access, exchange, and use of 
health care administrative information 
through electronic means; 
‘‘(ii) the implementation of utilization 
management protocols; and 
‘‘(iii) compliance with Federal and 
State laws. 
‘‘(d) USE
OF FUNDS
FOR IMPLEMENTATION.—A 
State may use amounts received under a grant under this 
section for one or more of the following:
231 
‘‘(1) The development, implementation, and 
best use of shared data infrastructure that supports 
the electronic transmission of administrative data. 
‘‘(2) The development and provision of training 
and educational materials, forums, and activities as 
well as technical assistance to effectively implement, 
use, and benefit from electronic health care trans-
actions and operating rules. 
‘‘(3) To accelerate the early adoption and im-
plementation of administrative transactions and op-
erating rules designated by the Secretary and that 
have been adopted pursuant to the Health Insurance 
Portability and Accountability Act of 1996 (Public 
Law 104–191), including transactions and operating 
rules described in section 1173(a)(2) of the Social 
Security Act. 
‘‘(4) To accelerate the early adoption and im-
plementation of additional or updated administrative 
transactions, operating rules, and related data ex-
change standards that are being considered for 
adoption under the Health Insurance Portability and 
Accountability Act of 1996 or are adopted pursuant 
to such Act, or as designated by the Secretary, in-
cluding the electronic claim attachment.
232 
‘‘(5) To conduct pilot projects to test ap-
proaches to implement and use the electronic health 
care transactions and operating rules in practice 
under a variety of different settings. With respect to 
the electronic attachment transaction, priority shall 
be given to pilot projects that test and evaluate 
methods and mechanisms to most effectively incor-
porate patient health data from electronic health 
records and other electronic sources with the elec-
tronic attachment transaction. 
‘‘(6) To assess barriers to the adoption, imple-
mentation, and effective use of electronic health care 
transactions and operating rules, as well as to ex-
plore, identify, and plan options, approaches, and re-
sources to address barriers and make improvements. 
‘‘(7) The facilitation of public and private ini-
tiatives to reduce administrative costs and accelerate 
the adoption, implementation, and effective use of 
electronic health care transactions and operating 
rules for State programs. 
‘‘(8) Developing, testing, implementing, and as-
sessing additional data exchange specifications, oper-
ating rules, incentives, requirements, tools, mecha-
nisms, and resources to accelerate the adoption and 
effective use of the transactions and operating rules.
233 
‘‘(9) Ongoing needs assessments and planning 
related to the development and implementation of 
administrative simplification initiatives. 
‘‘(e) COORDINATING ENTITY.— 
‘‘(1) FUNCTIONS.—Not later than 6 months 
after the date of enactment of this section, the Sec-
retary shall designate a coordinating entity under 
this subsection for the purpose of— 
‘‘(A) providing technical assistance to 
States relating to the simplification of adminis-
trative transactions and operating rules, in-
creased standardization, and the efficiency and 
effectiveness of the transmission of health care 
information; 
‘‘(B) evaluating pilot projects and other ef-
forts conducted under this section for impact 
and best practices to inform broader national 
use; 
‘‘(C) using consistent evaluation meth-
odologies to compare return on investment 
across efforts conducted under this section; 
‘‘(D) 
compiling, 
synthesizing, 
dissemi-
nating, and adopting lessons learned to promote 
the adoption of electronic health care trans-
234 
actions and operating rules across the health 
care system; and 
‘‘(E) making recommendations to the Sec-
retary and the National Committee on Vital 
and Health Statistics regarding the national 
adoption of efforts conducted under this sec-
tion. 
‘‘(2) 
ELIGIBILITY.—The 
entity 
designated 
under paragraph (1) shall be a qualified nonprofit 
entity that— 
‘‘(A) focuses its mission on administrative 
simplification; 
‘‘(B) has demonstrated experience using a 
multi-stakeholder and consensus-based process 
for the development of common, uniform speci-
fications, operating rules, best practices, and 
conventions, for the efficient, effective exchange 
of administrative transactions that includes rep-
resentation by or participation from health 
plans, health care providers, vendors, States, 
relevant Federal agencies, and other health care 
standard development organizations; 
‘‘(C) has demonstrated experience pro-
viding technical assistance to health plans, 
health care providers, vendors, and States relat-
235 
ing to the simplification of administrative trans-
actions and operating rules, increased standard-
ization, and the efficiency and effectiveness of 
the transmission of health care information; 
‘‘(D) has demonstrated experience evalu-
ating and measuring the adoption and return 
on investment of administrative transactions 
and operating rules; 
‘‘(E) has demonstrated experience gath-
ering, synthesizing, and adopting common, uni-
form specifications, operating rules, best prac-
tices, and conventions for national use based on 
lessons learned to promote the adoption of elec-
tronic health care transactions and operating 
rules across the health care system; 
‘‘(F) has a public set of guiding principles 
that ensure processes are open and transparent, 
and supports nondiscrimination and conflict of 
interest policies that demonstrate a commit-
ment to open, fair, and nondiscriminatory prac-
tices; 
‘‘(G) builds on the transaction standards 
issued under Health Insurance Portability and 
Accountability Act of 1996; and
236 
‘‘(H) allows for public review and updates 
of common, uniform specifications, operating 
rules, best practices, and conventions to support 
administrative simplification. 
‘‘(f) PERIOD AND AMOUNT.—A grant awarded to a 
State under this section shall be for a period of 5 years 
and shall not exceed $50,000,000 for such 5-year period. 
A grant awarded to the coordinating entity designated by 
the Secretary under subsection (e) shall be for a period 
of 5 years and shall not exceed $15,000,000 for such 5- 
year period. 
‘‘(g) REPORTS.— 
‘‘(1) STATES.—Not later than 1 year after re-
ceiving a grant under this section, and biennially 
thereafter, a State shall submit to the Secretary a 
report on the outcomes experienced by the State 
under the grant. 
‘‘(2) COORDINATING ENTITY.—Not later than 1 
year after receiving a grant under this section, and 
at least biennially thereafter, the coordinating entity 
shall submit to the Secretary and the National Com-
mittee on Vital and Health Statistics a report of 
evaluations conducted under the grant under this 
section and recommendations regarding the national 
adoption of efforts conducted under this section.
237 
‘‘(3) SECRETARY.—Not later than 6 months 
after the date on which the States and coordinating 
entity submit the report required under paragraphs 
(1) and (2), the Secretary, in consultation with Na-
tional Committee on Vital and Health Statistics, 
shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House 
of Representatives, a report on the outcomes 
achieved under the grants under this section. 
‘‘(4) GAO.—Not later than 6 months after the 
date on which the Secretary submits the final report 
under paragraph (3), the Comptroller General of the 
United States shall conduct a study, and submit to 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representa-
tives, a report on the outcomes of the activities car-
ried out under this section which shall contain a list 
of best practices and recommendations to States 
concerning administrative simplification. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section, 
$250,000,000 for the 5-fiscal-year period beginning with 
fiscal year 2020.’’.
238 
TITLE VIII—MISCELLANEOUS 
SEC. 801. GUARANTEED ISSUE OF CERTAIN MEDIGAP POLI-
CIES. 
(a) GUARANTEED ISSUE OF MEDIGAP POLICIES TO 
ALL MEDIGAP-ELIGIBLE MEDICARE BENEFICIARIES.— 
(1) IN GENERAL.—Section 1882(s) of the So-
cial Security Act (42 U.S.C. 1395ss(s)) is amend-
ed— 
(A) in paragraph (2)(A), by striking ‘‘65 
years of age or older and is enrolled for benefits 
under part B’’ and inserting ‘‘entitled to, or en-
rolled for, benefits under part A and enrolled 
for benefits under part B’’; 
(B) in paragraph (2)(D), by striking ‘‘who 
is 65 years of age or older as of the date of 
issuance and’’; 
(C) in paragraph (3)(B)(ii), by striking ‘‘is 
65 years of age or older and’’; and 
(D) in paragraph (3)(B)(vi), by striking 
‘‘at age 65’’. 
(2) ADDITIONAL
ENROLLMENT
PERIOD
FOR 
CERTAIN INDIVIDUALS.— 
(A) ONE-TIME ENROLLMENT PERIOD.— 
(i) IN
GENERAL.—In the case of a 
specified individual, the Secretary shall es-
239 
tablish a one-time enrollment period de-
scribed in clause (iii) during which such an 
individual may enroll in any medicare sup-
plemental policy of the individual’s choos-
ing. 
(ii) 
APPLICATION.—The 
provisions 
of— 
(I) paragraph (2) of section 
1882(s) of the Social Security Act (42 
U.S.C. 1395ss(s)) shall apply with re-
spect to a specified individual who is 
described in subclause (I) of subpara-
graph (B)(iii) as if references in such 
paragraph (2) to the 6 month period 
described in subparagraph (A) of such 
paragraph were references to the one- 
time enrollment period established 
under clause (i); and 
(II) paragraph (3) of such sec-
tion shall apply with respect to a spec-
ified individual who is described in 
subclause 
(II) 
of 
subparagraph 
(B)(iii) as if references in such para-
graph (3) to the period specified in 
subparagraph (E) of such paragraph
240 
were references to the one-time enroll-
ment period established under clause 
(i). 
(iii) PERIOD.—The enrollment period 
established under clause (i) shall be the 6- 
month period beginning on January 1, 
2024. 
(B) SPECIFIED
INDIVIDUAL.—For pur-
poses of this paragraph, the term ‘‘specified in-
dividual’’ means an individual who— 
(i) is entitled to hospital insurance 
benefits under part A of title XVIII of the 
Social Security Act (42 U.S.C. 1395c et 
seq.) pursuant to section 226(b) or section 
226A of such Act (42 U.S.C. 426(b); 426– 
1); 
(ii) is enrolled for benefits under part 
B of such Act (42 U.S.C. 1395j et seq.); 
and 
(iii)(I) would not, but for the amend-
ments made by subparagraphs (A) and (B) 
of paragraph (1) and the provisions of this 
paragraph (if such provisions applied to 
such individual), be eligible for the guaran-
teed issue of a medicare supplemental pol-
241 
icy under paragraph (2) of section 1882(s) 
of such Act (42 U.S.C. 1395ss(s)); or 
(II) would not, but for the amend-
ments made by subparagraphs (C) and (D) 
of paragraph (1) and the provisions of this 
paragraph (if such provisions applied to 
such individual), be eligible for the guaran-
teed issue of a medicare supplemental pol-
icy under paragraph (3) of such section. 
(C) OUTREACH PLAN.— 
(i) IN GENERAL.—The Secretary shall 
develop an outreach plan to notify specified 
individuals of the one-time enrollment pe-
riod established under subparagraph (A). 
(ii) 
CONSULTATION.—In 
imple-
menting the outreach plan developed under 
clause (i), the Secretary shall consult with 
consumer advocates, brokers, insurers, the 
National Association of Insurance Commis-
sioners, and State Health Insurance As-
sistance Programs. 
(3) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to medicare supple-
mental policies effective on or after January 1, 
2024.
242 
(b) GUARANTEED ISSUE OF MEDIGAP POLICIES FOR 
MEDICARE ADVANTAGE ENROLLEES.— 
(1) IN
GENERAL.—Section 1882(s)(3) of the 
Social Security Act (42 U.S.C. 1395ss(s)(3)), as 
amended by subsection (a), is further amended— 
(A) in subparagraph (B), by adding at the 
end the following new clause: 
‘‘(vii) The individual— 
‘‘(I) was enrolled in a Medicare Advantage 
plan under part C for not less than 12 months; 
‘‘(II) subsequently disenrolled from such 
plan; 
‘‘(III) elects to receive benefits under this 
title through the original Medicare fee-for-serv-
ice program under parts A and B; and 
‘‘(IV) has not previously elected to receive 
benefits under this title through the original 
Medicare fee-for-service program pursuant to 
disenrollment from a Medicare Advantage plan 
under part C.’’; 
(B) by striking subparagraph (C)(iii) and 
inserting the following: 
‘‘(iii) Subject to subsection (v)(1), for purposes of an 
individual described in clause (vi) or (vii) of subparagraph 
(B), a medicare supplemental policy described in this sub-
243 
paragraph shall include any medicare supplemental pol-
icy.’’; and 
(C) in subparagraph (E)— 
(i) in clause (iv), by striking ‘‘and’’ at 
the end; 
(ii) in clause (v), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing new clause— 
‘‘(vi) in the case of an individual described in 
subparagraph (B)(vii), the annual, coordinated elec-
tion period (as defined in section 1851(e)(3)(B)) or 
a continuous open enrollment period (as defined in 
section 1851(e)(2)) during which the individual 
disenrolls from a Medicare Advantage plan under 
part C.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to medicare supple-
mental policies effective on or after January 1, 
2024.
244 
SEC. 802. REPORTING REQUIREMENTS FOR PDP SPONSORS 
REGARDING 
POINT-OF-SALE 
REJECTIONS 
UNDER MEDICARE PART D. 
Section 1860D–4(g) of the Social Security Act (42 
U.S.C. 1395w–104(g)) is amended by adding at the end 
the following new paragraph: 
‘‘(3) REPORTING
REQUIREMENTS
REGARDING 
POINT-OF-SALE REJECTIONS.— 
‘‘(A) IN GENERAL.—With respect to a plan 
year beginning on or after January 1, 2020, a 
PDP sponsor offering a prescription drug plan 
shall submit to the Secretary, in a form and 
manner specified by the Secretary, information 
on point-of-sale rejections made during a period 
of time occurring in such plan year (as specified 
by the Secretary), including each of the fol-
lowing: 
‘‘(i) The reason for each point-of-sale 
rejection. 
‘‘(ii) Identifying information for each 
drug with respect to which a point-of-sale 
rejection was made. 
‘‘(iii) With respect to applicable types 
of point-of-sale rejections (as specified by 
the Secretary), each of the following:
245 
‘‘(I) Whether such a rejection 
was consistent with the formulary of 
the plan (as approved by the Sec-
retary). 
‘‘(II) Whether a coverage deter-
mination or appeal of a coverage de-
termination was requested for the 
drug with respect to which such a re-
jection was made. 
‘‘(III) The outcome of any such 
coverage determination or appeal of a 
coverage determination. 
‘‘(IV) The length of time between 
when such a rejection was made and 
when the drug with respect to which 
such rejection was made is dispensed, 
as applicable. 
‘‘(B) PUBLIC AVAILABILITY OF INFORMA-
TION.—The Secretary shall make publicly avail-
able on the public website of the Centers for 
Medicare & Medicaid Services information sub-
mitted under subparagraph (A). 
‘‘(C) USE
OF
INFORMATION.—The Sec-
retary may use information submitted under 
subparagraph (A), as determined appropriate,
246 
in developing measures for the 5-star rating 
system under section 1853(o)(4). 
‘‘(D) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
implement this paragraph through program in-
struction or otherwise. 
‘‘(E) FUNDING.—The are authorized to be 
appropriated to the Secretary from the Federal 
Supplementary Medical Insurance Trust Fund 
under section 1841 such sums as may be nec-
essary to implement this paragraph.’’. 
SEC. 803. PROVIDING ACCESS TO ANNUAL MEDICARE NOTI-
FICATIONS IN MULTIPLE LANGUAGES. 
(a) IN GENERAL.—Section 1804 of the Social Secu-
rity Act (42 U.S.C. 1395b–2) is amended by adding at 
the end the following new subsection: 
‘‘(e) The notice provided under subsection (a) shall 
be translated into languages in addition to English and 
Spanish. In carrying out the previous sentence, the Sec-
retary shall prioritize translation of the notice into lan-
guages in which documents provided by the Commissioner 
of Social Security are translated and language that are 
the most frequently requested for translation for purposes 
of applying for old-age insurance benefits under title II.’’.
247 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to notices distributed prior to 
each Medicare open enrollment period beginning after 
January 1, 2020. 
SEC. 804. TEMPORARY INCREASE IN MEDICARE PART B 
PAYMENT FOR CERTAIN BIOSIMILAR BIO-
LOGICAL PRODUCTS. 
Section 1847A(b)(8) of the Social Security Act (42 
U.S.C. 1395w–3a(b)(8)) is amended— 
(1) by redesignating subparagraphs (A) and 
(B) as clauses (i) and (ii), respectively, and moving 
the margin of each such redesignated clause 2 ems 
to the right; 
(2) by striking ‘‘PRODUCT.—The amount’’ and 
inserting the following: ‘‘PRODUCT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the amount’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(B) TEMPORARY PAYMENT INCREASE.— 
‘‘(i) IN GENERAL.—In the case of a 
qualifying biosimilar biological product 
that is furnished during the applicable 5- 
year period for such product, the amount 
specified in this paragraph for such prod-
248 
uct with respect to such period is the sum 
determined under subparagraph (A), ex-
cept that clause (ii) of such subparagraph 
shall be applied by substituting ‘8 percent’ 
for ‘6 percent’. 
‘‘(ii) APPLICABLE 5-YEAR PERIOD.— 
For purposes of clause (i), the applicable 
5-year period for a biosimilar biological 
product is— 
‘‘(I) in the case of such a product 
for which payment was made under 
this paragraph as of December 31, 
2019, the 5-year period beginning on 
January 1, 2020; and 
‘‘(II) in the case of such a prod-
uct for which payment is first made 
under this paragraph during a cal-
endar quarter during the period be-
ginning January 1, 2020, and ending 
December 31, 2024, the 5-year period 
beginning on the first day of such cal-
endar quarter during which such pay-
ment is first made. 
‘‘(iii) QUALIFYING
BIOSIMILAR
BIO-
LOGICAL
PRODUCT
DEFINED.—For pur-
249 
poses of this subparagraph, the term 
‘qualifying biosimilar biological product’ 
means a biosimilar biological product de-
scribed in paragraph (1)(C) with respect to 
which— 
‘‘(I) in the case of a product de-
scribed in clause (ii)(I), the average 
sales price is not more than the aver-
age sales price for the reference bio-
logical product; and 
‘‘(II) in the case of a product de-
scribed in clause (ii)(II), the wholesale 
acquisition cost is not more than the 
wholesale acquisition cost for the ref-
erence biological product.’’. 
SEC. 
805. 
WAIVING 
MEDICARE 
COINSURANCE 
FOR 
COLORECTAL CANCER SCREENING TESTS. 
Section 1833(a) of the Social Security Act (42 U.S.C. 
1395l(a)) is amended— 
(1) in the second sentence, by striking ‘‘section 
1834(0)’’ and inserting ‘‘section 1834(o)’’; 
(2) by moving such second sentence 2 ems to 
the left; and 
(3) by inserting the following third sentence fol-
lowing such second sentence: ‘‘For services furnished
250 
on or after January 1, 2021, paragraph (1)(Y) shall 
apply with respect to a colorectal cancer screening 
test regardless of the code that is billed for the es-
tablishment of a diagnosis as a result of the test, or 
for the removal of tissue or other matter or other 
procedure that is furnished in connection with, as a 
result of, and in the same clinical encounter as the 
screening test.’’. 
SEC. 
806. 
MEDICARE 
COVERAGE 
OF 
CERTAIN 
LYMPHEDEMA 
COMPRESSION 
TREATMENT 
ITEMS. 
(a) COVERAGE.— 
(1) IN GENERAL.—Section 1861 of the Social 
Security Act (42 U.S.C. 1395x), as amended by sec-
tion 601 and section 603, is further amended— 
(A) in subsection (s)(2)— 
(i) in subparagraph (II), by striking 
‘‘and’’ after the semicolon at the end; 
(ii) in subparagraph (JJ), by striking 
the period at the end and inserting ‘‘; 
and’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(KK) lymphedema compression treatment 
items (as defined in subsection (mmm));’’; and
251 
(B) by adding at the end the following new 
subsection: 
‘‘(mmm) LYMPHEDEMA COMPRESSION TREATMENT 
ITEMS.—The term ‘lymphedema compression treatment 
items’ means compression garments, devices, bandaging 
systems, components, and supplies, including multilayer 
compression bandaging systems, standard fit gradient 
compression garments, and other compression garments, 
devices, bandaging systems, components, or supplies (as 
determined by the Secretary), that are— 
‘‘(1) furnished on or after January 1, 2022, to 
an individual with a diagnosis of lymphedema for the 
treatment of such condition; 
‘‘(2) primarily and customarily used in the 
medical treatment of lymphedema, as determined by 
the Secretary; and 
‘‘(3) prescribed by a physician (or a physician 
assistant, nurse practitioner, or a clinical nurse spe-
cialist (as those terms are defined in section 
1861(aa)(5)) to the extent authorized under State 
law).’’. 
(2) PAYMENT.— 
(A) IN GENERAL.—Section 1833(a)(1) of 
the 
Social 
Security 
Act 
(42 
U.S.C.
252 
1395l(a)(1)), as amended by section 601(c)(1), 
is further amended— 
(i) by striking ‘‘and’’ before ‘‘(DD)’’; 
and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘, and (EE) with 
respect to lymphedema compression treat-
ment 
items 
(as 
defined 
in 
section 
1861(mmm)), the amount paid shall be 
equal to 80 percent of the lesser of the ac-
tual charge or the amount determined 
under the payment basis determined under 
section 1834(z)’’. 
(B) PAYMENT BASIS AND LIMITATIONS.— 
Section 1834 of the Social Security Act (42 
U.S.C. 1395m), as amended by sections 
601(c)(2) and 603(c), is further amended by 
adding at the end the following new subsection: 
‘‘(z) PAYMENT
FOR LYMPHEDEMA COMPRESSION 
TREATMENT ITEMS.— 
‘‘(1) IN GENERAL.—The Secretary shall deter-
mine an appropriate payment basis for lymphedema 
compression treatment items (as defined in section 
1861(mmm)). In making such a determination, the 
Secretary may take into account payment rates for
253 
such items under State plans (or waivers of such 
plans) under title XIX, the Veterans Health Admin-
istration, and group health plans and health insur-
ance coverage (as such terms are defined in section 
2791 of the Public Health Service Act), and such 
other information as the Secretary determines ap-
propriate. 
‘‘(2) FREQUENCY
LIMITATION.—No payment 
may be made under this part for lymphedema com-
pression treatment items furnished other than at 
such frequency as the Secretary may establish. 
‘‘(3) APPLICATION OF COMPETITIVE ACQUISI-
TION.—In the case of lymphedema compression 
treatment items that are included in a competitive 
acquisition program in a competitive acquisition area 
under section 1847(a)— 
‘‘(A) the payment basis under this sub-
section for such items furnished in such area 
shall be the payment basis determined under 
such competitive acquisition program; and 
‘‘(B) the Secretary may use information on 
the payment determined under such competitive 
acquisition programs to adjust the payment 
amount otherwise determined under this sub-
section for an area that is not a competitive ac-
254 
quisition area under section 1847, and in the 
case of such adjustment, paragraphs (8) and 
(9) of section 1842(b) shall not be applied.’’. 
(3) CONFORMING AMENDMENTS.— 
(A) EXCLUSIONS.—Section 1862(a)(1) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395y(a)(1)), as amended by section 601(f) and 
section 603(g), is further amended— 
(i) in subparagraph (Q), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (R), by striking 
the semicolon and inserting ‘‘, and’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(S) in the case of lymphedema compression 
treatment items (as defined in section 1861(mmm)), 
which are furnished more frequently than is estab-
lished pursuant to section 1834(z)(2);’’. 
(B) APPLICATION OF COMPETITIVE ACQUI-
SITION.— 
(i) IN GENERAL.—Section 1847(a)(2) 
of the Social Security Act (42 U.S.C. 
1395w–3(a)(2)), as amended by sections 
601(e)(2)(B)(ii), 
602(b)(3)(B)(i), 
and 
603(f)(2)(B), is further amended by add-
255 
ing at the end the following new subpara-
graph: 
‘‘(G) LYMPHEDEMA COMPRESSION TREAT-
MENT ITEMS.—Lymphedema compression treat-
ment items (as defined in section 1861(mmm)) 
for which payment would otherwise be made 
under section 1834(z).’’. 
(b) INCLUSION IN REQUIREMENTS FOR SUPPLIERS 
OF
MEDICAL
EQUIPMENT
AND
SUPPLIES.—Section 
1834(j)(5) of the Social Security Act (42 U.S.C. 
1395m(j)(5)) is amended— 
(1) by redesignating subparagraphs (E) and 
(F) as subparagraphs (F) and (G), respectively; and 
(2) by inserting after subparagraph (D) the fol-
lowing new subparagraph: 
‘‘(E) lymphedema compression treatment 
items (as defined in section 1861(mmm));’’. 
(c) STUDY AND REPORT ON IMPLEMENTATION.— 
(1) STUDY.—The Secretary of Health and 
Human Services (in this section referred to as the 
‘‘Secretary’’) shall conduct a study on the implemen-
tation of Medicare coverage of certain lymphedema 
compression treatment items under the amendments 
made by this Act. Such study shall include an eval-
uation of the following:
256 
(A) Medicare beneficiary utilization of 
items and services under parts A and B of title 
XVIII of the Social Security Act as a result of 
the implementation of such amendments. 
(B) Whether the Secretary has determined, 
pursuant to section 1861(mmm) of the Social 
Security Act, as added by subsection (a)(1), 
that lymphedema compression treatment items 
other than compression bandaging systems and 
standard fit gradient compression garments are 
covered under such section. 
(2) REPORT.—Not later than January 1, 2024, 
the Secretary shall submit to Congress and make 
available to the public a report on the study con-
ducted under paragraph (1). 
SEC. 807. PHYSICIAN FEE UPDATE. 
Section 1848(d)(19) of the Social Security Act (42 
U.S.C. 1395w–4(d)(19)) is amended to read as follows: 
‘‘(19) UPDATE FOR 2020 THROUGH 2025.—The 
update to the single conversion factor established in 
paragraph (1)(C)— 
‘‘(A) for each of 2020 through 2022 shall 
be 0.5 percent; and 
‘‘(B) for each of 2023 through 2025 shall 
be 0.0 percent.’’.
257 
SEC. 
808. 
ADDITIONAL 
COMMUNITY 
HEALTH 
CENTER 
FUNDING. 
Section 10503 of the Patient Protection and Afford-
able Care Act (42 U.S.C. 254b–2) is amended by striking 
subsection (c) and inserting the following: 
‘‘(c) ADDITIONAL ENHANCED FUNDING; CAPITAL 
PROJECTS.—There is authorized to be appropriated, and 
there is appropriated, out of any monies in the Treasury 
not otherwise appropriated, to the CHC Fund— 
‘‘(1) to be transferred to the Secretary of 
Health and Human Services to provide additional 
enhanced funding for the community health center 
program under section 330 of the Public Health 
Service Act, $1,000,000,000 for each of fiscal years 
2021 through 2025; and 
‘‘(2) to be transferred to the Secretary of 
Health and Human Services for capital projects of 
the community health center program under section 
330 
of 
the 
Public 
Health 
Service 
Act, 
$5,000,000,000 for the period of fiscal years 2021 
through 2025.’’.
258 
SEC. 809. GRANTS TO IMPROVE TRAUMA SUPPORT SERV-
ICES AND MENTAL HEALTH CARE FOR CHIL-
DREN AND YOUTH IN EDUCATIONAL SET-
TINGS. 
(a) 
GRANTS, 
CONTRACTS, 
AND
COOPERATIVE 
AGREEMENTS AUTHORIZED.—The Secretary, in coordina-
tion with the Assistant Secretary for Mental Health and 
Substance Use, is authorized to award grants to, or enter 
into contracts or cooperative agreements with, State edu-
cational agencies, local educational agencies, Indian Tribes 
(as defined in section 4 of the Indian Self-Determination 
and Education Assistance Act) or their tribal educational 
agencies, a school operated by the Bureau of Indian Edu-
cation, a Regional Corporation, or a Native Hawaiian edu-
cational organization, for the purpose of increasing stu-
dent access to evidence-based trauma support services and 
mental health care by developing innovative initiatives, ac-
tivities, or programs to link local school systems with local 
trauma-informed support and mental health systems, in-
cluding those under the Indian Health Service. 
(b) DURATION.—With respect to a grant, contract, 
or cooperative agreement awarded or entered into under 
this section, the period during which payments under such 
grant, contract, or agreement are made to the recipient 
may not exceed 4 years.
259 
(c) USE OF FUNDS.—An entity that receives a grant, 
contract, or cooperative agreement under this section shall 
use amounts made available through such grant, contract, 
or cooperative agreement for evidence-based activities, 
which shall include any of the following: 
(1) Collaborative efforts between school-based 
service systems and trauma-informed support and 
mental health service systems to provide, develop, or 
improve prevention, screening, referral, and treat-
ment and support services to students, such as pro-
viding trauma screenings to identify students in 
need of specialized support. 
(2) To implement schoolwide positive behavioral 
interventions and supports, or other trauma-in-
formed models of support. 
(3) To provide professional development to 
teachers, teacher assistants, school leaders, special-
ized instructional support personnel, and mental 
health professionals that— 
(A) fosters safe and stable learning envi-
ronments that prevent and mitigate the effects 
of trauma, including through social and emo-
tional learning; 
(B) improves school capacity to identify, 
refer, and provide services to students in need
260 
of trauma support or behavioral health services; 
or 
(C) reflects the best practices for trauma- 
informed identification, referral, and support 
developed by the Interagency Task Force on 
Trauma-Informed Care. 
(4) Services at a full-service community school 
that focuses on trauma-informed supports, which 
may include a full-time site coordinator, or other ac-
tivities consistent with section 4625 of the Elemen-
tary and Secondary Education Act of 1965 (20 
U.S.C. 7275). 
(5) Engaging families and communities in ef-
forts to increase awareness of child and youth trau-
ma, which may include sharing best practices with 
law enforcement regarding trauma-informed care 
and working with mental health professionals to pro-
vide interventions, as well as longer term coordi-
nated care within the community for children and 
youth who have experienced trauma and their fami-
lies. 
(6) To provide technical assistance to school 
systems and mental health agencies. 
(7) To evaluate the effectiveness of the program 
carried out under this section in increasing student
261 
access to evidence-based trauma support services 
and mental health care. 
(8) To establish partnerships with or provide 
subgrants to Head Start agencies (including Early 
Head Start agencies), public and private preschool 
programs, child care programs (including home- 
based providers), or other entities described in sub-
section (a), to include such entities described in this 
paragraph in the evidence-based trauma initiatives, 
activities, support services, and mental health sys-
tems established under this section in order to pro-
vide, develop, or improve prevention, screening, re-
ferral, and treatment and support services to young 
children and their families. 
(d) APPLICATIONS.—To be eligible to receive a grant, 
contract, or cooperative agreement under this section, an 
entity described in subsection (a) shall submit an applica-
tion to the Secretary at such time, in such manner, and 
containing such information as the Secretary may reason-
ably require, which shall include the following: 
(1) A description of the innovative initiatives, 
activities, or programs to be funded under the grant, 
contract, or cooperative agreement, including how 
such program will increase access to evidence-based 
trauma support services and mental health care for
262 
students, and, as applicable, the families of such stu-
dents. 
(2) A description of how the program will pro-
vide linguistically appropriate and culturally com-
petent services. 
(3) A description of how the program will sup-
port students and the school in improving the school 
climate in order to support an environment condu-
cive to learning. 
(4) An assurance that— 
(A) persons providing services under the 
grant, contract, or cooperative agreement are 
adequately trained to provide such services; and 
(B) teachers, school leaders, administra-
tors, specialized instructional support personnel, 
representatives of local Indian Tribes or tribal 
organizations as appropriate, other school per-
sonnel, and parents or guardians of students 
participating in services under this section will 
be engaged and involved in the design and im-
plementation of the services. 
(5) A description of how the applicant will sup-
port and integrate existing school-based services 
with the program in order to provide mental health 
services for students, as appropriate.
263 
(6) A description of the entities in the commu-
nity with which the applicant will partner or to 
which the applicant will provide subgrants in accord-
ance with subsection (c)(8). 
(e) INTERAGENCY AGREEMENTS.— 
(1) LOCAL
INTERAGENCY
AGREEMENTS.—To 
ensure the provision of the services described in sub-
section (c), a recipient of a grant, contract, or coop-
erative agreement under this section, or their des-
ignee, shall establish a local interagency agreement 
among local educational agencies, agencies respon-
sible for early childhood education programs, Head 
Start agencies (including Early Head Start agen-
cies), juvenile justice authorities, mental health 
agencies, child welfare agencies, and other relevant 
agencies, authorities, or entities in the community 
that will be involved in the provision of such serv-
ices. 
(2) CONTENTS.—In ensuring the provision of 
the services described in subsection (c), the local 
interagency agreement shall specify with respect to 
each agency, authority, or entity that is a party to 
such agreement— 
(A) the financial responsibility for the serv-
ices;
264 
(B) the conditions and terms of responsi-
bility for the services, including quality, ac-
countability, and coordination of the services; 
and 
(C) the conditions and terms of reimburse-
ment among such agencies, authorities, or enti-
ties, including procedures for dispute resolution. 
(f) EVALUATION.—The Secretary shall reserve not 
more than 3 percent of the funds made available under 
subsection (l) for each fiscal year to— 
(1) conduct a rigorous, independent evaluation 
of the activities funded under this section; and 
(2) disseminate and promote the utilization of 
evidence-based practices regarding trauma support 
services and mental health care. 
(g) DISTRIBUTION OF AWARDS.—The Secretary shall 
ensure that grants, contracts, and cooperative agreements 
awarded or entered into under this section are equitably 
distributed among the geographical regions of the United 
States and among tribal, urban, suburban, and rural pop-
ulations. 
(h) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed— 
(1) to prohibit an entity involved with a pro-
gram carried out under this section from reporting
265 
a crime that is committed by a student to appro-
priate authorities; or 
(2) to prevent Federal, State, and tribal law en-
forcement and judicial authorities from exercising 
their responsibilities with regard to the application 
of Federal, tribal, and State law to crimes com-
mitted by a student. 
(i) SUPPLEMENT, NOT SUPPLANT.—Any services 
provided through programs carried out under this section 
shall supplement, and not supplant, existing mental health 
services, including any special education and related serv-
ices provided under the Individuals with Disabilities Edu-
cation Act (20 U.S.C. 1400 et seq.). 
(j) CONSULTATION WITH INDIAN TRIBES.—In car-
rying out subsection (a), the Secretary shall, in a timely 
manner, meaningfully consult with Indian Tribes and their 
representatives to ensure notice of eligibility. 
(k) DEFINITIONS.—In this section: 
(1) ELEMENTARY SCHOOL.—The term ‘‘elemen-
tary school’’ has the meaning given such term in 
section 8101 of the Elementary and Secondary Edu-
cation Act of 1965 (20 U.S.C. 7801). 
(2) EVIDENCE-BASED.—The term ‘‘evidence- 
based’’ has the meaning given such term in section
266 
8101(21)(A)(i) of the Elementary and Secondary 
Education Act of 1965 (20 U.S.C. 7801(21)(A)(i)). 
(3) NATIVE HAWAIIAN EDUCATIONAL ORGANI-
ZATION.—The term ‘‘Native Hawaiian educational 
organization’’ has the meaning given such term in 
section 6207 of the Elementary and Secondary Edu-
cation Act of 1965 (20 U.S.C. 7517). 
(4) LOCAL EDUCATIONAL AGENCY.—The term 
‘‘local educational agency’’ has the meaning given 
such term in section 8101 of the Elementary and 
Secondary Education Act of 1965 (20 U.S.C. 7801). 
(5) REGIONAL CORPORATION.—The term ‘‘Re-
gional Corporation’’ has the meaning given the term 
in section 3 of the Alaska Native Claims Settlement 
Act (43 U.S.C. 1602). 
(6) SCHOOL.—The term ‘‘school’’ means a pub-
lic elementary school or public secondary school. 
(7) SCHOOL LEADER.—The term ‘‘school lead-
er’’ has the meaning given such term in section 
8101 of the Elementary and Secondary Education 
Act of 1965 (20 U.S.C. 7801). 
(8) SECONDARY
SCHOOL.—The term ‘‘sec-
ondary school’’ has the meaning given such term in 
section 8101 of the Elementary and Secondary Edu-
cation Act of 1965 (20 U.S.C. 7801).
267 
(9) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Education. 
(10) SPECIALIZED
INSTRUCTIONAL
SUPPORT 
PERSONNEL.—The term ‘‘specialized instructional 
support personnel’’ has the meaning given such term 
in section 8101 of the Elementary and Secondary 
Education Act of 1965 (20 U.S.C. 7801). 
(11) STATE EDUCATIONAL AGENCY.—The term 
‘‘State educational agency’’ has the meaning given 
such term in section 8101 of the Elementary and 
Secondary Education Act of 1965 (20 U.S.C. 7801). 
(l) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated, and there is appropriated, 
out of any money in the Treasury not otherwise appro-
priated, to carry out this section, $20,000,000 for each 
of fiscal years 2021 through 2025. 
SEC. 810. PATHWAY TO HEALTH CAREERS ACT. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Pathways to Health Careers Act’’. 
(b) EXTENSION THROUGH FISCAL YEAR 2020 OF 
FUNDING FOR DEMONSTRATION PROJECTS TO ADDRESS 
HEALTH PROFESSIONS WORKFORCE NEEDS.— 
(1) IN
GENERAL.—Section 2008(c)(1) of the 
Social Security Act (42 U.S.C. 1397g(c)(1)) is 
amended by striking ‘‘2019.’’ and inserting ‘‘2020,
268 
and to provide technical assistance and cover admin-
istrative costs associated with implementing the suc-
cessor to this section $15,000,000 for fiscal year 
2020.’’. 
(2) AVAILABILITY
OF
OTHER
FUNDS.—Upon 
the date of the enactment of this section— 
(A) amounts expended pursuant to section 
1501 of division B of Public Law 116–59, or 
any other prior law making amounts available 
for fiscal year 2020 for activities authorized by 
section 2008 of the Social Security Act, shall be 
charged to the appropriation made by sub-
section (c)(1) of such section 2008 for fiscal 
year 2020 (not including the amount for tech-
nical assistance and administrative costs); and 
(B) if such enactment occurs on or before 
November 21, 2019, the availability of funds 
appropriated in, and the authority provided 
under, such section 1501 shall terminate. 
(c) CAREER PATHWAYS THROUGH HEALTH PROFES-
SION OPPORTUNITY GRANTS.—Effective October 1, 2020, 
section 2008 of the Social Security Act (42 U.S.C. 1397g) 
is amended to read as follows:
269 
‘‘SEC. 2008. CAREER PATHWAYS THROUGH HEALTH PRO-
FESSION OPPORTUNITY GRANTS. 
‘‘(a) APPLICATION REQUIREMENTS.—An eligible en-
tity desiring a grant under this section for a project shall 
submit to the Secretary an application for the grant, that 
includes the following: 
‘‘(1) A description of how the applicant will use 
a career pathways approach to train eligible individ-
uals for health professions that pay well or will put 
eligible individuals on a career path to an occupation 
that pays well, under the project. 
‘‘(2) A description of the adult basic education 
and literacy activities, work readiness activities, 
training activities, and case management and career 
coaching services that the applicant will use to assist 
eligible individuals to gain work experience, connec-
tion to employers, and job placement, and a descrip-
tion of the plan for recruiting, hiring, and training 
staff to provide the case management, mentoring, 
and career coaching services, under the project di-
rectly or through local governmental, apprenticeship, 
educational, or charitable institutions. 
‘‘(3) In the case of an application for a grant 
under this section for a demonstration project de-
scribed in subsection (c)(2)(B)(i)(I)—
271 
‘‘(D) a proof of concept or demonstration 
that the applicant has done sufficient research 
on workforce shortage or in-demand jobs for 
which people with certain types of arrest or 
conviction records can be hired; 
‘‘(E) a plan for recruiting students who 
are eligible individuals into the project; and 
‘‘(F) a plan for providing post-employment 
support and ongoing training as part of a ca-
reer pathway under the project. 
‘‘(4) In the case of an application for a grant 
under this section for a demonstration project de-
scribed in subsection (c)(2)(B)(i)(II)— 
‘‘(A) a description of the partnerships, 
strategic staff hiring decisions, tailored program 
activities, or other programmatic elements of 
the project, such as training plans for doulas 
and other community health workers and train-
ing plans for midwives and other allied health 
professions, that are designed to support a ca-
reer pathway in pregnancy, birth, or post- 
partum services; and 
‘‘(B) a demonstration that the State in 
which the demonstration project is to be con-
272 
ducted recognizes doulas or midwives, as the 
case may be. 
‘‘(5) A demonstration that the applicant has ex-
perience working with low-income populations, or a 
description of the plan of the applicant to work with 
a partner organization that has the experience. 
‘‘(6) A plan for providing post-employment sup-
port and ongoing training as part of a career path-
way under the project. 
‘‘(7) A description of the support services that 
the applicant will provide under the project, includ-
ing a plan for how child care and transportation 
support services will be guaranteed and, if the appli-
cant will provide a cash stipend or wage supplement, 
how the stipend or supplement would be calculated 
and distributed. 
‘‘(8) A certification by the applicant that the 
project development included— 
‘‘(A) consultation with a local workforce 
development board established under section 
107 of the Workforce Innovation and Oppor-
tunity Act; 
‘‘(B) consideration of apprenticeship and 
pre-apprenticeship models registered under the
273 
Act of August 16, 1937 (also known as the 
‘National Apprenticeship Act’); 
‘‘(C) consideration of career pathway pro-
grams in the State in which the project is to be 
conducted; and 
‘‘(D) a review of the State plan under sec-
tion 102 or 103 of the Workforce Innovation 
and Opportunity Act. 
‘‘(9) A description of the availability and rel-
evance of recent labor market information and other 
pertinent evidence of in-demand jobs or worker 
shortages. 
‘‘(10) A certification that the applicant will di-
rectly provide or contract for the training services 
described in the application. 
‘‘(11) A commitment by the applicant that, if 
the grant is made to the applicant, the applicant 
will— 
‘‘(A) during the planning period for the 
project, provide the Secretary with any informa-
tion needed by the Secretary to establish ade-
quate data reporting and administrative struc-
ture for the project;
274 
‘‘(B) hire a person to direct the project not 
later than the end of the planning period appli-
cable to the project; 
‘‘(C) accept all technical assistance offered 
by the Secretary with respect to the grant; 
‘‘(D) participate in such in-person grantee 
conferences as are regularly scheduled by the 
Secretary; 
‘‘(E) provide all data required by the Sec-
retary under subsection (g); and 
‘‘(F) notify the local disabled veterans’ 
outreach program specialists under section 
4103A of title 38, United States Code, and the 
local 
veterans’ 
employment 
representatives 
under section 4104 of such title, of the grant-
ee’s outreach plan for advertising training op-
portunities to potential participants in the 
project. 
‘‘(b) PREFERENCES
IN
CONSIDERING
APPLICA-
TIONS.—In considering applications for a grant under this 
section, the Secretary shall give preference to— 
‘‘(1) applications submitted by applicants to 
whom a grant was made under this section or any 
predecessor to this section;
275 
‘‘(2) applications submitted by applicants who 
have business and community partners in each of 
the following categories: 
‘‘(A) State and local government agencies 
and social service providers, including a State 
or local entity that administers a State program 
funded under part A of this title; 
‘‘(B) institutions of higher education, ap-
prenticeship programs, and local workforce de-
velopment boards established under section 107 
of the Workforce Innovation and Opportunity 
Act; and 
‘‘(C) health care employers, health care in-
dustry or sector partnerships, labor unions, and 
labor-management partnerships; 
‘‘(3) applications that include opportunities for 
mentoring or peer support, and make career coach-
ing available, as part of the case management plan; 
‘‘(4) applications which describe a project that 
will serve a rural area in which— 
‘‘(A) the community in which the individ-
uals to be enrolled in the project reside is lo-
cated; 
‘‘(B) the project will be conducted; or
276 
‘‘(C) an employer partnership that has 
committed to hiring individuals who successfully 
complete all activities under the project is lo-
cated; 
‘‘(5) applications that include a commitment to 
providing project participants with a cash stipend or 
wage supplement; and 
‘‘(6) applications which have an emergency cash 
fund to assist project participants financially in 
emergency situations. 
‘‘(c) GRANTS.— 
‘‘(1) COMPETITIVE GRANTS.— 
‘‘(A) GRANT AUTHORITY.— 
‘‘(i) IN GENERAL.—The Secretary, in 
consultation with the Secretary of Labor 
and the Secretary of Education, may make 
a grant in accordance with this paragraph 
to an eligible entity whose application for 
the grant is approved by the Secretary, to 
conduct a project designed to train low-in-
come individuals for allied health profes-
sions, health information technology, physi-
cians assistants, nursing assistants, reg-
istered nurse, advanced practice nurse, and
277 
other professions considered part of a 
health care career pathway model. 
‘‘(ii) GUARANTEE
OF
GRANTEES
IN 
EACH STATE AND THE DISTRICT OF CO-
LUMBIA.—For each grant cycle, the Sec-
retary shall award a grant under this para-
graph to at least 2 eligible entities in each 
State that is not a territory, to the extent 
there are a sufficient number of applica-
tions submitted by the entities that meet 
the requirements applicable with respect to 
such a grant. If, for a grant cycle, there 
are fewer than 2 such eligible entities in a 
State, the Secretary shall include that in-
formation in the report required by sub-
section (g)(2) that covers the fiscal year. 
‘‘(B) GUARANTEE OF GRANTS FOR INDIAN 
POPULATIONS.—From the amount reserved 
under subsection (i)(2)(B) for each fiscal year, 
the Secretary shall award a grant under this 
paragraph to at least 10 eligible entities that 
are an Indian tribe, a tribal organization, or a 
tribal college or university, to the extent there 
are a sufficient number of applications sub-
278 
mitted by the entities that meet the require-
ments applicable with respect to such a grant. 
‘‘(C) GUARANTEE OF GRANTEES IN THE 
TERRITORIES.—From 
the 
amount 
reserved 
under subsection (i)(2)(C) for each fiscal year, 
the Secretary shall award a grant under this 
paragraph to at least 2 eligible entities that are 
located in a territory, to the extent there are a 
sufficient number of applications submitted by 
the entities that meet the requirements applica-
ble with respect to such a grant. 
‘‘(2) 
GRANTS
FOR
DEMONSTRATION 
PROJECTS.— 
‘‘(A) GRANT AUTHORITY.—The Secretary, 
in consultation with the Secretary of Labor and 
the Secretary of Education (and, with respect 
to demonstration projects of the type described 
in subparagraph (B)(i)(I), the Attorney Gen-
eral) shall make a grant in accordance with this 
subsection to an eligible entity whose applica-
tion for the grant is approved by the Secretary, 
to conduct a demonstration project that meets 
the requirements of subparagraph (B). 
‘‘(B) REQUIREMENTS.—The requirements 
of this subparagraph are the following:
279 
‘‘(i) TYPE
OF
PROJECT.—The dem-
onstration project shall be of 1 of the fol-
lowing types: 
‘‘(I) INDIVIDUALS WITH ARREST 
OR
CONVICTION
RECORDS
DEM-
ONSTRATION.—The 
demonstration 
project shall be of a type designed to 
provide education and training for eli-
gible individuals with arrest or convic-
tion records to enter and follow a ca-
reer pathway in the health professions 
through occupations that pay well and 
are expected to experience a labor 
shortage or be in high demand. 
‘‘(II) PREGNANCY
AND
CHILD-
BIRTH
CAREER
PATHWAY
DEM-
ONSTRATION.—The 
demonstration 
project shall be of a type designed to 
provide education and training for eli-
gible individuals to enter and follow a 
career pathway in the field of preg-
nancy, childbirth, or post-partum, in a 
State that recognizes doulas or mid-
wives and that provides payment for 
services provided by doulas or mid-
280 
wives, as the case may be, under pri-
vate or public health insurance plans. 
‘‘(ii) DURATION.—The demonstration 
project shall be conducted for not less than 
5 years. 
‘‘(C) MINIMUM
ALLOCATION
OF
FUNDS 
FOR
EACH
TYPE
OF
DEMONSTRATION 
PROJECT.— 
‘‘(i) INDIVIDUALS
WITH
ARREST
OR 
CONVICTION
RECORDS
DEMONSTRA-
TIONS.—Not less than 25 percent of the 
amounts made available for grants under 
this paragraph shall be used to make 
grants for demonstration projects of the 
type described in subparagraph (B)(i)(I). 
‘‘(ii) PREGNANCY
AND
CHILDBIRTH 
CAREER
PATHWAY
DEMONSTRATIONS.— 
Not less than 25 percent of the amounts 
made available for grants under this para-
graph shall be used to make grants for 
demonstration projects of the type de-
scribed in subparagraph (B)(i)(II). 
‘‘(3) GRANT
CYCLE.—The grant cycle under 
this section shall be not less than 5 years, with a 
planning period of not more than the 1st 12 months
281 
of the grant cycle. During the planning period, the 
amount of the grant shall be in such lesser amount 
as the Secretary determines appropriate. 
‘‘(d) USE OF GRANT.— 
‘‘(1) IN GENERAL.—An entity to which a grant 
is made under this section shall use the grant in ac-
cordance with the approved application for the 
grant. 
‘‘(2) SUPPORT TO BE PROVIDED.— 
‘‘(A) REQUIRED SUPPORT.—A project for 
which a grant is made under this section shall 
include the following: 
‘‘(i) An assessment for adult basic 
skill competency, and provision of adult 
basic skills education if necessary for 
lower-skilled eligible individuals to enroll in 
the project and go on to enter and com-
plete 
post-secondary 
training, 
through 
means including the following: 
‘‘(I) Establishing a network of 
partners that offer pre-training activi-
ties for project participants who need 
to improve basic academic skills or 
English language proficiency before
282 
entering a health occupational train-
ing career pathway program. 
‘‘(II) Offering resources to enable 
project participants to continue ad-
vancing adult basic skill proficiency 
while enrolled in a career pathway 
program. 
‘‘(III) Embedding adult basic 
skill maintenance as part of ongoing 
post-graduation career coaching and 
mentoring. 
‘‘(ii) A guarantee that child care is an 
available and affordable support service for 
project participants through means such as 
the following: 
‘‘(I) Referral to, and assistance 
with, enrollment in a subsidized child 
care program. 
‘‘(II) Direct payment to a child 
care provider if a slot in a subsidized 
child care program is not available or 
reasonably accessible. 
‘‘(III) Payment of co-payments 
or associated fees for child care.
283 
‘‘(iii) Case management plans that in-
clude career coaching (with the option to 
offer appropriate peer support and men-
toring opportunities to help develop soft 
skills and social capital), which may be of-
fered on an ongoing basis before, during, 
and after initial training as part of a ca-
reer pathway model. 
‘‘(iv) A plan to provide project partici-
pants with transportation through means 
such as the following: 
‘‘(I) Referral to, and assistance 
with enrollment in, a subsidized trans-
portation program. 
‘‘(II) If a subsidized transpor-
tation program is not reasonably 
available, direct payments to subsidize 
transportation costs. 
For purposes of this clause, the term 
‘transportation’ includes public transit, or 
gasoline for a personal vehicle if public 
transit is not reasonably accessible or 
available. 
‘‘(v) In the case of a demonstration 
project of the type described in subsection
284 
(c)(2)(B)(i)(I), access to legal assistance 
for project participants for the purpose of 
addressing arrest or conviction records and 
associated workforce barriers. 
‘‘(B) ALLOWED SUPPORT.—The goods and 
services provided under a project for which a 
grant is made under this section may include 
the following: 
‘‘(i) A cash stipend that is at least 
monthly. 
‘‘(ii) A reserve fund for financial as-
sistance to project participants in emer-
gency situations. 
‘‘(iii) Tuition, and training materials 
such as books, software, uniforms, shoes, 
and hair nets. 
‘‘(iv) In-kind resource donations such 
as interview clothing and conference at-
tendance fees. 
‘‘(v) Assistance with accessing and 
completing high school equivalency or adult 
basic education courses as necessary to 
achieve success in the project and make 
progress toward career goals.
285 
‘‘(vi) Assistance with programs and 
activities, 
including 
legal 
assistance, 
deemed necessary to address arrest or con-
viction records as an employment barrier. 
‘‘(vii) 
Other 
support 
services 
as 
deemed necessary for family well-being, 
success in the project, and progress toward 
career goals. 
‘‘(C) TREATMENT OF SUPPORT FOR PUR-
POSES
OF
MEANS-TESTED
PROGRAMS.—Any 
goods or services provided to an eligible indi-
vidual participating in a project for which a 
grant is made under this section shall not be 
considered income, and shall not be taken into 
account for purposes of determining the eligi-
bility of the individual for, or amount of bene-
fits to be provided to the individual, under any 
means-tested program. 
‘‘(3) TRAINING.—The number of hours of train-
ing provided to an eligible individual under a project 
for which a grant is made under this section, for a 
recognized postsecondary credential, including an in-
dustry-recognized credential, which is awarded in 
recognition of attainment of measurable technical or 
occupational skills necessary to gain employment or
286 
advance within an occupation (including a certificate 
awarded by a local workforce development board es-
tablished under section 107 of the Workforce Inno-
vation and Opportunity Act), shall be— 
‘‘(A) not less than the number of hours of 
training required for certification in that level 
of skill by the State in which the project is con-
ducted; or 
‘‘(B) if there is no such requirement, such 
number of hours of training as the Secretary 
finds is necessary to achieve that skill level. 
‘‘(4) INCOME LIMITATION.—An entity to which 
a grant is made under this section shall not use the 
grant to provide support to a person who is not an 
eligible individual. 
‘‘(5) INCLUSION OF TANF RECIPIENTS.—In the 
case of a project for which a grant is made under 
this section that is conducted in a State that has a 
program funded under part A of title IV, at least 10 
percent of the eligible individuals to whom support 
is provided under the project shall meet the income 
eligibility requirements under that State program, 
without regard to whether the individuals receive 
benefits or services directly under that State pro-
gram.
287 
‘‘(6) PROHIBITION.—An entity to which a grant 
is made under this section shall not use the grant 
for purposes of entertainment, except that case man-
agement and career coaching services may include 
celebrations of specific career-based milestones such 
as completing a semester, graduation, or job place-
ment. 
‘‘(e) TECHNICAL ASSISTANCE.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
technical assistance— 
‘‘(A) to assist eligible entities in applying 
for grants under this section; 
‘‘(B) that is tailored to meet the needs of 
grantees at each stage of the administration of 
projects for which grants are made under this 
section; 
‘‘(C) that is tailored to meet the specific 
needs of Indian tribes, tribal organizations, and 
tribal colleges and universities; 
‘‘(D) that is tailored to meet the specific 
needs of the territories; 
‘‘(E) that is tailored to meet the specific 
needs of eligible entities in carrying out dem-
onstration projects for which a grant is made 
under this section; and
288 
‘‘(F) to facilitate the exchange of informa-
tion among eligible entities regarding best prac-
tices and promising practices used in the 
projects. 
‘‘(2) CONTINUATION OF PEER TECHNICAL AS-
SISTANCE CONFERENCES.—The Secretary shall con-
tinue to hold peer technical assistance conferences 
for entities to which a grant is made under this sec-
tion or was made under the immediate predecessor 
of this section. 
‘‘(f) EVALUATION OF DEMONSTRATION PROJECTS.— 
‘‘(1) IN
GENERAL.—The Secretary shall, by 
grant, contract, or interagency agreement, conduct 
rigorous and well-designed evaluations of the dem-
onstration projects for which a grant is made under 
this section. 
‘‘(2) REQUIREMENT APPLICABLE TO INDIVID-
UALS WITH ARREST OR CONVICTION RECORDS DEM-
ONSTRATION.—In the case of a project of the type 
described in subsection (c)(2)(B)(i)(I), the evalua-
tion shall include identification of successful activi-
ties for creating opportunities for developing and 
sustaining, particularly with respect to low-income 
individuals with arrest or conviction records, a 
health professions workforce that has accessible
289 
entry points, that meets high standards for edu-
cation, training, certification, and professional devel-
opment, and that provides increased wages and af-
fordable benefits, including health care coverage, 
that are responsive to the needs of the workforce. 
‘‘(3) REQUIREMENT
APPLICABLE
TO
PREG-
NANCY AND CHILDBIRTH CAREER PATHWAY DEM-
ONSTRATION.—In the case of a project of the type 
described in subsection (c)(2)(B)(i)(II), the evalua-
tion shall include identification of successful activi-
ties for creating opportunities for developing and 
sustaining, particularly with respect to low-income 
individuals and other entry-level workers, a career 
pathway that has accessible entry points, that meets 
high standards for education, training, certification, 
and professional development, and that provides in-
creased wages and affordable benefits, including 
health care coverage, that are responsive to the 
needs of the birth, pregnancy, and post-partum 
workforce. 
‘‘(4) RULE OF INTERPRETATION.—Evaluations 
conducted pursuant to this subsection may include a 
randomized controlled trial, but this subsection shall 
not be interpreted to require an evaluation to include 
such a trial.
290 
‘‘(g) REPORTS.— 
‘‘(1) TO THE SECRETARY.—An eligible entity 
awarded a grant to conduct a project under this sec-
tion shall submit interim reports to the Secretary on 
the activities carried out under the project, and, on 
the conclusion of the project, a final report on the 
activities. Each such report shall include data on 
participant outcomes related to earnings, employ-
ment in health professions, graduation rate, gradua-
tion timeliness, credential attainment, participant 
demographics, and other data specified by the Sec-
retary. 
‘‘(2) TO THE CONGRESS.—During each Con-
gress, the Secretary shall submit to the Committee 
on Ways and Means of the House of Representatives 
and the Committee on Finance of the Senate a re-
port— 
‘‘(A) on the demographics of the partici-
pants in the projects for which a grant is made 
under this section; 
‘‘(B) on the rate of which project partici-
pants 
completed 
all 
activities 
under 
the 
projects; 
‘‘(C) on the employment credentials ac-
quired by project participants;
291 
‘‘(D) on the employment of project partici-
pants on completion of activities under the 
projects, and the earnings of project partici-
pants at entry into employment; 
‘‘(E) on best practices and promising prac-
tices used in the projects; 
‘‘(F) on the nature of any technical assist-
ance provided to grantees under this section; 
‘‘(G) on, with respect to the period since 
the period covered in the most recent prior re-
port submitted under this paragraph— 
‘‘(i) the number of applications sub-
mitted under this section, with a separate 
statement of the number of applications re-
ferred to in subsection (b)(5); 
‘‘(ii) the number of applications that 
were approved, with a separate statement 
of the number of such applications referred 
to in subsection (b)(5); and 
‘‘(iii) a description of how grants were 
made in any case described in the last sen-
tence of subsection (c)(1)(A)(ii); and 
‘‘(H) that includes an assessment of the ef-
fectiveness of the projects with respect to ad-
292 
dressing health professions workforce shortages 
or in-demand jobs. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) ALLIED HEALTH PROFESSION.—The term 
‘allied health profession’ has the meaning given in 
section 799B(5) of the Public Health Service Act. 
‘‘(2) CAREER
PATHWAY.—The term ‘career 
pathway’ has the meaning given that term in section 
3(7) of the Workforce Innovation and Opportunity 
Act. 
‘‘(3) DOULA.—The term ‘doula’ means an indi-
vidual who— 
‘‘(A) is certified by an organization that 
has been established for not less than 5 years 
and that requires the completion of continuing 
education to maintain the certification, to pro-
vide non-medical advice, information, emotional 
support, and physical comfort to an individual 
during the individual’s pregnancy, childbirth, 
and post-partum period; and 
‘‘(B) maintains the certification by com-
pleting the required continuing education. 
‘‘(4) ELIGIBLE ENTITY.—The term ‘eligible en-
tity’ means any of the following entities that dem-
onstrates in an application submitted under this sec-
293 
tion that the entity has the capacity to fully develop 
and administer the project described in the applica-
tion: 
‘‘(A) A local workforce development board 
established under section 107 of the Workforce 
Innovation and Opportunity Act. 
‘‘(B) A State or territory, a political sub-
division of a State or territory, or an agency of 
a State, territory, or such a political subdivi-
sion, including a State or local entity that ad-
ministers a State program funded under part A 
of this title. 
‘‘(C) An Indian tribe, a tribal organization, 
or a tribal college or university. 
‘‘(D) An institution of higher education (as 
defined in the Higher Education Act of 1965). 
‘‘(E) A hospital (as defined in section 
1861(e)). 
‘‘(F) A high-quality skilled nursing facility. 
‘‘(G) A Federally qualified health center 
(as defined in section 1861(aa)(4)). 
‘‘(H) A nonprofit organization described in 
section 501(c)(3) of the Internal Revenue Code 
of 1986, a labor organization, or an entity with 
shared labor-management oversight, that has a
294 
demonstrated history of providing health profes-
sion training to eligible individuals. 
‘‘(I) In the case of a demonstration project 
of 
the 
type 
provided 
for 
in 
subsection 
(c)(2)(B)(i)(II) of this section, an entity recog-
nized by a State, Indian tribe, or tribal organi-
zation as qualified to train doulas or midwives, 
if midwives or doulas, as the case may be, are 
permitted to practice in the State involved. 
‘‘(J) An opioid treatment program (as de-
fined in section 1861(jjj)(2)), and other high 
quality comprehensive addiction care providers. 
‘‘(5) ELIGIBLE INDIVIDUAL.—The term ‘eligible 
individual’ means an individual whose family income 
does not exceed 200 percent of the Federal poverty 
level. 
‘‘(6) FEDERAL
POVERTY
LEVEL.—The term 
‘Federal poverty level’ means the poverty line (as de-
fined in section 673(2) of the Omnibus Budget Rec-
onciliation Act of 1981, including any revision re-
quired by such section applicable to a family of the 
size involved). 
‘‘(7) INDIAN TRIBE; TRIBAL ORGANIZATION.— 
The terms ‘Indian tribe’ and ‘tribal organization’ 
have the meaning given the terms in section 4 of the
295 
Indian Self-Determination and Education Assistance 
Act (25 U.S.C. 450b). 
‘‘(8) INSTITUTION OF HIGHER EDUCATION.— 
The term ‘institution of higher education’ has the 
meaning given the term in section 101 or 
102(a)(1)(B) of the Higher Education Act of 1965. 
‘‘(9) TERRITORY.—The term ‘territory’ means 
the Commonwealth of Puerto Rico, the United 
States Virgin Islands, Guam, the Northern Mariana 
Islands, and American Samoa. 
‘‘(10) TRIBAL COLLEGE OR UNIVERSITY.—The 
term ‘tribal college or university’ has the meaning 
given the term in section 316(b) of the Higher Edu-
cation Act of 1965. 
‘‘(i) FUNDING.— 
‘‘(1) IN GENERAL.—Out of any funds in the 
Treasury of the United States not otherwise appro-
priated, there are appropriated to the Secretary to 
carry out this section $425,000,000 for each of fis-
cal years 2021 through 2025. 
‘‘(2) ALLOCATION OF FUNDS.—Of the amount 
appropriated for a fiscal year under paragraph (1) 
of this subsection— 
‘‘(A) 75 percent shall be available for 
grants under subsection (c)(1)(A);
296 
‘‘(B) 4 percent shall be reserved for grants 
under subsection (c)(1)(B); 
‘‘(C) 5 percent shall be reserved for grants 
under subsection (c)(1)(C); 
‘‘(D) 6 percent shall be available for dem-
onstration project grants under subsection 
(c)(2); 
‘‘(E) 6 percent, plus all amounts referred 
to in subparagraphs (A) through (D) of this 
paragraph that remain unused after all grant 
awards are made for the fiscal year, shall be 
available for the provision of technical assist-
ance and associated staffing; and 
‘‘(F) 4 percent shall be available for study-
ing the effects of the demonstration and non- 
demonstration projects for which a grant is 
made under this section, and for associated 
staffing, for the purpose of supporting the rig-
orous evaluation of the demonstration projects, 
and supporting the continued study of the 
short-, medium-, and long-term effects of all 
such projects, including the effectiveness of new 
or added elements of the non-demonstration 
projects.
297 
‘‘(j) NONAPPLICABILITY OF PRECEDING SECTIONS 
OF THIS SUBTITLE.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the preceding sections of this subtitle 
shall not apply to a grant awarded under this sec-
tion. 
‘‘(2) EXCEPTION FOR CERTAIN LIMITATIONS ON 
USE OF GRANTS.—Section 2005(a) (other than para-
graphs (2), (3), (5), (6), and (8)) shall apply to a 
grant awarded under this section to the same extent 
and in the same manner as such section applies to 
payments to States under this subtitle.’’. 
SEC. 811. HOME VISITING TO REDUCE MATERNAL MOR-
TALITY AND MORBIDITY ACT. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Home Visiting to Reduce Maternal Mortality and Mor-
bidity Act’’. 
(b) INCREASE
IN TRIBAL SET-ASIDE PERCENT-
AGE.— 
(1) IN GENERAL.—Section 511(j)(2)(A) of the 
Social Security Act (42 U.S.C. 711(j)(2)(A)) is 
amended by striking ‘‘3’’ and inserting ‘‘6’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall take effect on October 1, 
2020.
298 
(c) INCREASE IN FUNDING.—Section 511(j)(1) of 
such Act (42 U.S.C. 711(j)(1)) is amended— 
(1) by striking ‘‘and’’ at the end of subpara-
graph (G); and 
(2) by striking subparagraph (H) and inserting 
the following: 
‘‘(H) $400,000,000 for each of fiscal years 
2017 through 2020; 
‘‘(I) $600,000,000 for fiscal year 2021; 
and 
‘‘(J) $800,000,000 for fiscal year 2022.’’. 
(d) USE OF ADDITIONAL FUNDS.—Section 511(c) of 
such Act (42 U.S.C. 711(c)) is amended by adding at the 
end the following: 
‘‘(6) USE OF CERTAIN FUNDS TO PROVIDE AD-
DITIONAL RESOURCES TO ADDRESS HIGH RATES OF 
MATERNAL
MORTALITY
AND
MORBIDITY, SUPPORT 
UNMET NEEDS IDENTIFIED BY THE NEEDS ASSESS-
MENT, OR INCREASE ALLOCATIONS TO STATES AND 
TERRITORIES BASED ON RELATIVE POPULATION OR 
POVERTY.—The Secretary shall ensure that any 
amounts exceeding $400,000,000 that are used for 
grants under this subsection for a fiscal year are 
used to—
299 
‘‘(A) provide additional funding priority to 
States, tribes, and territories to address high 
rates of maternal mortality and morbidity; 
‘‘(B) address unmet needs identified by a 
needs assessment conducted under subsection 
(b); or 
‘‘(C) increase the amounts allocated under 
this section to States and to Puerto Rico, 
Guam, the Virgin Islands, the Northern Mar-
iana Islands, and American Samoa, based on 
the proportion of children who have not at-
tained 5 years of age and are living in pov-
erty.’’. 
SEC. 812. ADDITION OF NEW MEASURES BASED ON ACCESS 
TO BIOSIMILAR BIOLOGICAL PRODUCTS TO 
THE 5-STAR RATING SYSTEM UNDER MEDI-
CARE ADVANTAGE. 
(a) IN GENERAL.—Section 1853(o)(4) of the Social 
Security Act (42 U.S.C. 1395w–23(o)(4)) is amended by 
adding at the end the following new subparagraph: 
‘‘(E) ADDITION OF NEW MEASURES BASED 
ON ACCESS TO BIOSIMILAR BIOLOGICAL PROD-
UCTS.— 
‘‘(i) IN
GENERAL.—For 2021 and 
subsequent years, the Secretary shall add a
300 
new set of measures to the 5-star rating 
system based on access to biosimilar bio-
logical products covered under part B and, 
in the case of MA–PD plans, such prod-
ucts that are covered part D drugs. Such 
measures shall assess the impact a plan’s 
benefit structure may have on enrollees’ 
utilization of or ability to access biosimilar 
biological products, including in compari-
son to the reference biological product, and 
shall include measures, as applicable, with 
respect to the following: 
‘‘(I) 
COVERAGE.—Assessing 
whether a biosimilar biological prod-
uct is on the plan formulary in lieu of 
or in addition to the reference biologi-
cal product. 
‘‘(II) 
PREFERENCING.—Assess-
ing tier placement or cost-sharing for 
a biosimilar biological product relative 
to the reference biological product. 
‘‘(III) 
UTILIZATION
MANAGE-
MENT TOOLS.—Assessing whether and 
how utilization management tools are 
used with respect to a biosimilar bio-
301 
logical product relative to the ref-
erence biological product. 
‘‘(IV) 
UTILIZATION.—Assessing 
the percentage of enrollees prescribed 
the biosimilar biological product when 
the reference biological product is also 
available. 
‘‘(ii) DEFINITIONS.—In this subpara-
graph, the terms ‘biosimilar biological 
product’ and ‘reference biological product’ 
have the meaning given those terms in sec-
tion 1847A(c)(6). 
‘‘(iii) PROTECTING
PATIENT
INTER-
ESTS.—In developing such measures, the 
Secretary shall ensure that each measure 
developed 
to 
address 
coverage, 
preferencing, or utilization management is 
constructed such that patients retain equal 
access to appropriate therapeutic options 
without undue administrative burden.’’. 
(b) CLARIFICATION REGARDING APPLICATION
TO 
PRESCRIPTION DRUG PLANS.—To the extent the Sec-
retary of Health and Human Services applies the 5-star 
rating system under section 1853(o)(4) of the Social Secu-
rity Act (42 U.S.C. 1395w–23(o)(4)), or a similar system,
302 
to prescription drug plans under part D of title XVIII of 
such Act, the provisions of subparagraph (E) of such sec-
tion, as added by subsection (a) of this section, shall apply 
under the system with respect to such plans in the same 
manner as such provisions apply to the 5-star rating sys-
tem under such section 1853(o)(4). 
SEC. 813. SENSE OF CONGRESS REGARDING THE IMPACT 
OF 
THE 
HIGH 
COST 
OF 
PRESCRIPTION 
DRUGS ON COMMUNITIES OF COLOR AND 
PERSONS LIVING IN RURAL OR SPARSELY 
POPULATED AREAS OF THE UNITED STATES. 
It is the sense of the Congress that— 
(1) the United States has the highest drug 
prices in the world and for millions of Americans the 
cost of prescription drugs is increasing as a barrier 
to proper disease treatment, especially for commu-
nities of color and for persons living in rural or 
sparsely populated areas of the nation; 
(2) the Patient Protection and Affordable Care 
Act (Public Law 111–148) substantially reduced the 
number of uninsured Americans, but over 28 million 
Americans remain without insurance and approxi-
mately 55 percent of uninsured Americans under the 
age of 65 are persons of color;
303 
(3) without health insurance, paying retail 
prices for medications is invariably burdensome or 
financially impossible; 
(4) the median net worth of Caucasian house-
holds in 2016 was 9.7 times higher than African- 
American households and 8.3 times higher than His-
panic households, which contributes to disparities in 
negative health consequences, including for example 
the underuse of insulin among insured adults with 
diabetes; and 
(5) due to the high cost of prescription drugs 
to communities of color and for persons living in 
rural or sparsely populated areas of the nation, this 
Act should positively impact such communities and 
persons (and the Secretaries of Health and Human 
Services, Labor, and Treasury should monitor such 
impact). 
SEC. 
814. 
REGULATIONS 
REQUIRING 
DIRECT-TO-CON-
SUMER ADVERTISEMENTS FOR PRESCRIP-
TION DRUGS AND BIOLOGICAL PRODUCTS TO 
INCLUDE TRUTHFUL AND NOT MISLEADING 
PRICING INFORMATION. 
(a) IN GENERAL.—Not later than the date that is 
one year after the date of the enactment of the Elijah E. 
Cummings Lower Drug Costs Now Act, the Secretary of
304 
Health and Human Services, acting through the Adminis-
trator of the Centers for Medicare & Medicaid Services 
(referred to in this section as the ‘‘Administrator’’), shall 
promulgate final regulations requiring each direct-to-con-
sumer advertisement on television (including broadcast, 
cable, streaming, and satellite television) for a prescription 
drug or biological product for which payment is available 
under title XVIII or XIX of the Social Security Act to 
include a textual statement, which shall be truthful and 
not misleading, indicating the list price, as determined on 
the first day of the quarter during which the advertise-
ment is being aired or otherwise broadcast, for a typical 
30-day regimen or typical course of treatment (whichever 
is most appropriate). 
(b) DETERMINATIONS.—In promulgating final regu-
lations under subsection (a), the Administrator shall de-
termine— 
(1) whether such regulations should apply with 
respect to additional forms of advertising; 
(2) the manner and format of textual state-
ments described in such subsection; 
(3) appropriate enforcement mechanisms; and 
(4) whether such textual statements should in-
clude any other price information, as appropriate.
305 
SEC. 815. IMPROVING TRANSPARENCY AND PREVENTING 
THE USE OF ABUSIVE SPREAD PRICING AND 
RELATED PRACTICES IN MEDICAID. 
(a) PASS-THROUGH PRICING REQUIRED.— 
(1) IN GENERAL.—Section 1927(e) of the So-
cial Security Act (42 U.S.C. 1396r–8(e)) is amended 
by adding at the end the following: 
‘‘(6) PASS-THROUGH
PRICING
REQUIRED.—A 
contract between the State and a pharmacy benefit 
manager (referred to in this paragraph as a ‘PBM’), 
or a contract between the State and a managed care 
entity or other specified entity (as such terms are 
defined in section 1903(m)(9)(D)) that includes pro-
visions making the entity responsible for coverage of 
covered outpatient drugs dispensed to individuals en-
rolled with the entity, shall require that payment for 
such drugs and related administrative services (as 
applicable), including payments made by a PBM on 
behalf of the State or entity, is based on a pass- 
through pricing model under which— 
‘‘(A) any payment made by the entity or 
the PBM (as applicable) for such a drug— 
‘‘(i) is limited to— 
‘‘(I) ingredient cost; and 
‘‘(II) a professional dispensing 
fee that is not less than the profes-
306 
sional dispensing fee that the State 
plan or waiver would pay if the plan 
or waiver was making the payment di-
rectly; 
‘‘(ii) is passed through in its entirety 
by the entity or PBM to the pharmacy 
that dispenses the drug; and 
‘‘(iii) is made in a manner that is con-
sistent with section 1902(a)(30)(A) and 
sections 447.512, 447.514, and 447.518 of 
title 42, Code of Federal Regulations (or 
any successor regulation) as if such re-
quirements applied directly to the entity or 
the PBM; 
‘‘(B) payment to the entity or the PBM 
(as applicable) for administrative services per-
formed by the entity or PBM is limited to a 
reasonable administrative fee that covers the 
reasonable cost of providing such services; 
‘‘(C) the entity or the PBM (as applicable) 
shall make available to the State, and the Sec-
retary upon request, all costs and payments re-
lated to covered outpatient drugs and accom-
panying administrative services incurred, re-
ceived, or made by the entity or the PBM, in-
307 
cluding ingredient costs, professional dispensing 
fees, administrative fees, post-sale and post-in- 
voice fees. Discounts, or related adjustments 
such as direct and indirect remuneration fees, 
and any and all remuneration; and 
‘‘(D) any form of spread pricing whereby 
any amount charged or claimed by the entity or 
the PBM (as applicable) that is in excess of the 
amount paid to the pharmacies on behalf of the 
entity, including any post-sale or post-invoice 
fees, discounts, or related adjustments such as 
direct and indirect remuneration fees or assess-
ments (after allowing for a reasonable adminis-
trative fee as described in subparagraph (B)), is 
not allowable for purposes of claiming Federal 
matching payments under this title.’’. 
(2) CONFORMING
AMENDMENT.—Clause (xiii) 
of section 1903(m)(2)(A) of such Act (42 U.S.C. 
1396b(m)(2)(A)) is amended— 
(A) by striking ‘‘and (III)’’ and inserting 
‘‘(III)’’; and 
(B) by inserting before the period at the 
end the following: ‘‘, and (IV) pharmacy benefit 
management services provided by the entity, or 
provided by a pharmacy benefit manager on be-
308 
half of the entity under a contract or other ar-
rangement between the entity and the phar-
macy benefit manager, shall comply with the re-
quirements of section 1927(e)(6)’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection apply to contracts between States 
and managed care entities, other specified entities, 
or pharmacy benefits managers that are entered into 
or renewed on or after the date that is 18 months 
after the date of enactment of this Act. 
(b) SURVEY OF RETAIL PRICES.— 
(1) IN GENERAL.—Section 1927(f) of the Social 
Security Act (42 U.S.C. 1396r–8(f)) is amended— 
(A) by striking ‘‘and’’ after the semicolon 
at the end of paragraph (1)(A)(i) and all that 
precedes it through ‘‘(1)’’ and inserting the fol-
lowing: 
‘‘(1) SURVEY
OF
RETAIL
PRICES.—The Sec-
retary shall conduct a survey of retail community 
drug prices, to include at least the national average 
drug acquisition cost, as follows: 
‘‘(A) USE
OF
VENDOR.—The Secretary 
may contract services for— 
‘‘(i) with respect to retail community 
pharmacies, the determination on a month-
309 
ly basis of retail survey prices of the na-
tional average drug acquisition cost for 
covered outpatient drugs for such phar-
macies, net of all discounts and rebates (to 
the extent any information with respect to 
such discounts and rebates is available), 
the average reimbursement received for 
such drugs by such pharmacies from all 
sources of payment, including third par-
ties, and, to the extent available, the usual 
and customary charges to consumers for 
such drugs; and’’; 
(B) by adding at the end of paragraph (1) 
the following: 
‘‘(F) SURVEY
REPORTING.—In order to 
meet the requirement of section 1902(a)(54), a 
State shall require that any retail community 
pharmacy in the State that receives any pay-
ment, administrative fee, discount, or rebate re-
lated to the dispensing of covered outpatient 
drugs to individuals receiving benefits under 
this title, regardless of whether such payment, 
fee, discount, or rebate is received from the 
State or a managed care entity directly or from 
a pharmacy benefit manager or another entity
310 
that has a contract with the State or a man-
aged care entity, shall respond to surveys of re-
tail prices conducted under this subsection. 
‘‘(G) SURVEY INFORMATION.—Information 
on retail community prices obtained under this 
paragraph shall be made publicly available and 
shall include at least the following: 
‘‘(i) The monthly response rate of the 
survey including a list of pharmacies not in 
compliance with subparagraph (F). 
‘‘(ii) The sampling frame and number 
of pharmacies sampled monthly. 
‘‘(iii) 
Characteristics 
of 
reporting 
pharmacies, including type (such as inde-
pendent or chain), geographic or regional 
location, and dispensing volume. 
‘‘(iv) Reporting of a separate national 
average drug acquisition cost for each drug 
for independent retail pharmacies and 
chain operated pharmacies. 
‘‘(v) Information on price concessions 
including on and off invoice discounts, re-
bates, and other price concessions. 
‘‘(vi) Information on average profes-
sional dispensing fees paid.
311 
‘‘(H) PENALTIES.— 
‘‘(i) FAILURE TO PROVIDE TIMELY IN-
FORMATION.—A retail community phar-
macy that fails to respond to a survey con-
ducted under this subsection on a timely 
basis may be subject to a civil monetary 
penalty in the amount of $10,000 for each 
day in which such information has not 
been provided. 
‘‘(ii) FALSE INFORMATION.—A retail 
community pharmacy that knowingly pro-
vides false information in response to a 
survey conducted under this subsection 
may be subject to a civil money penalty in 
an amount not to exceed $100,000 for 
each item of false information. 
‘‘(iii) OTHER
PENALTIES.—Any civil 
money penalties imposed under this sub-
paragraph shall be in addition to other 
penalties as may be prescribed by law. The 
provisions of section 1128A (other than 
subsections (a) and (b)) shall apply to a 
civil money penalty under this subpara-
graph in the same manner as such provi-
312 
sions apply to a penalty or proceedings 
under section 1128A(a). 
‘‘(I) 
REPORT
ON
SPECIALTY
PHAR-
MACIES.— 
‘‘(i) IN GENERAL.—Not later than 1 
year after the effective date of this sub-
paragraph, the Secretary shall submit a re-
port to Congress examining specialty drug 
coverage and reimbursement under this 
title. 
‘‘(ii) CONTENT OF REPORT.—Such re-
port shall include a description of how 
State Medicaid programs define specialty 
drugs, how much State Medicaid programs 
pay for specialty drugs, how States and 
managed care plans determine payment for 
specialty drugs, the settings in which spe-
cialty drugs are dispensed (such as retail 
community pharmacies or specialty phar-
macies), whether acquisition costs for spe-
cialty drugs are captured in the national 
average drug acquisition cost survey, and 
recommendations as to whether specialty 
pharmacies should be included in the sur-
vey of retail prices to ensure national aver-
313 
age drug acquisition costs capture drugs 
sold at specialty pharmacies and how such 
specialty pharmacies should be defined.’’; 
(C) in paragraph (2)— 
(i) in subparagraph (A), by inserting 
‘‘, including payments rates under Med-
icaid managed care plans,’’ after ‘‘under 
this title’’; and 
(ii) in subparagraph (B), by inserting 
‘‘and the basis for such dispensing fees’’ 
before the semicolon; and 
(D) in paragraph (4), by inserting ‘‘, and 
$5,000,000 for fiscal year 2020 and each fiscal 
year thereafter,’’ after ‘‘2010’’. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection take effect on the 1st day of the 
1st quarter that begins on or after the date that is 
18 months after the date of enactment of this Act. 
(c) MANUFACTURER REPORTING
OF WHOLESALE 
ACQUISITION COST.—Section 1927(b)(3) of such Act (42 
U.S.C. 1396r–8(b)(3)) is amended— 
(1) in subparagraph (A)(i)— 
(A) in subclause (I), by striking ‘‘and’’ 
after the semicolon;
314 
(B) in subclause (II), by adding ‘‘and’’ 
after the semicolon; 
(C) by moving the left margins of sub-
clause (I) and (II) 2 ems to the right; and 
(D) by adding at the end the following: 
‘‘(III) in the case of rebate peri-
ods that begin on or after the date of 
enactment of this subclause, on the 
wholesale acquisition cost (as defined 
in section 1847A(c)(6)(B)) for cov-
ered outpatient drugs for the rebate 
period under the agreement (including 
for all such drugs that are sold under 
a new drug application approved 
under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act);’’; and 
(2) in subparagraph (D)— 
(A) in the matter preceding clause (i), by 
inserting ‘‘and clause (vii) of this subpara-
graph’’ after ‘‘1847A’’; 
(B) in clause (v), by striking ‘‘and’’ after 
the comma; 
(C) in clause (vi), by striking the period 
and inserting ‘‘, and’’; and
315 
(D) by inserting after clause (vi) the fol-
lowing: 
‘‘(vii) to the Secretary to disclose 
(through a website accessible to the public) 
the most recently reported wholesale acqui-
sition 
cost 
(as 
defined 
in 
section 
1847A(c)(6)(B)) for each covered out-
patient drug (including for all such drugs 
that are sold under a new drug application 
approved under section 505(c) of the Fed-
eral Food, Drug, and Cosmetic Act), as re-
ported under subparagraph (A)(i)(III).’’. 
SEC. 816. GRADUATE MEDICAL EDUCATION IMPROVE-
MENTS IN RURAL AND UNDERSERVED COM-
MUNITIES. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end 
the following new section: 
‘‘SEC. 399V–7. GRADUATE MEDICAL EDUCATION IMPROVE-
MENTS IN RURAL AND UNDERSERVED COM-
MUNITIES. 
‘‘(a) RURAL AND UNDERSERVED COMMUNITY GME 
GRANT PROGRAM.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services (in this section referred to as the ‘Sec-
316 
retary’), acting through the Administrator of the Health 
Resources and Services Administration, shall establish a 
rural and underserved community graduate medical edu-
cation grant program under which the Secretary shall 
award grants to specified hospitals (as defined in sub-
section (b)) that have not established an approved medical 
residency training program (as defined for purposes of 
section 1886(h) of the Social Security Act (42 U.S.C. 
1395ww(h))) in order to encourage such hospitals to es-
tablish such a program, or to establish an affiliation with 
a hospital that has established such a program in order 
to host residents under such program. 
‘‘(b) USE OF FUNDS.—Grants awarded under sub-
section (a) may be used by a specified hospital for any 
initial costs associated with establishing such a program 
or such an affiliation, including costs associated with fac-
ulty development, administration, infrastructure, supplies, 
and legal and consultant services. 
‘‘(c) SPECIFIED HOSPITAL DEFINED.—For purposes 
of subsection (a), the term ‘specified hospital’ means a 
hospital or critical access hospital (as such terms are de-
fined in section 1861 of the Social Security Act (42 U.S.C. 
1395x)) that— 
‘‘(1) is—
317 
‘‘(A) located in a rural area (as defined in 
section 1886(d)(2)(D) of such Act (42 U.S.C. 
1395ww(d)(2)(D))); or 
‘‘(B) treated as being located in a rural 
area pursuant to section 1886(d)(8)(E) of such 
Act (42 U.S.C. 1395ww(d)(8)(E)); and 
‘‘(2) is located in a medically underserved area 
(as defined in section 330I(a) of the Public Health 
Service Act (42 U.S.C. 254c–14(a))). 
‘‘(d) CRITICAL
ACCESS
HOSPITAL
GRANT
PRO-
GRAM.—Not later than 1 year after the date of the enact-
ment of this Act, the Secretary, acting through the Admin-
istrator of the Health Resources and Services Administra-
tion, shall establish a grant program under which the Sec-
retary awards grants to critical access hospitals (as de-
fined in section 1861 of the Social Security Act (42 U.S.C. 
1395x)) that do not have in effect an affiliation with a 
hospital with an approved medical residency training pro-
gram to host residents of such program in order to assist 
such critical access hospitals in setting up such affiliations 
in order to host such residents. 
‘‘(e) LIMITATION ON GRANT AMOUNTS.—No hospital 
may receive an aggregate amount of grants under this sec-
tion in excess of $250,000. 
‘‘(f) REPORTS.—
318 
‘‘(1) HHS.—Not later than 5 years after the 
date of the enactment of this Act, the Secretary of 
Health and Human Services shall submit to the 
Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a re-
port on graduate medical residency training pro-
grams of hospitals that received a grant under sub-
section (a) or (d). Such report shall include the fol-
lowing: 
‘‘(A) The number of hospitals that applied 
for a grant under this section. 
‘‘(B) The number of hospitals that were 
awarded such a grant. 
‘‘(C) The number of residency positions 
created by hospitals receiving such a grant. 
‘‘(D) An estimate of the number of such 
positions such hospitals will create after the 
date of the submission of such report. 
‘‘(E) A description of any challenges faced 
by hospitals in applying for such a grant or 
using funds awarded under such a grant. 
‘‘(2) GAO.—Not later than 10 years after the 
date of the enactment of this Act, the Comptroller
319 
General of the United States shall submit to Con-
gress a report containing an analysis of— 
‘‘(A) the number of residents who trained 
at a hospital or critical access hospital that re-
ceived a grant under subsection (a) or (d); and 
‘‘(B) whether such residents continued to 
practice medicine in a rural area (as defined in 
section 1886(d)(2)(D) of the Social Security 
Act (42 U.S.C. 1395ww(d)(2)(D))) or in a 
medically underserved area (as defined in sec-
tion 330I(a) of the Public Health Service Act 
(42 U.S.C. 254c–14(a))) after completing such 
training. 
‘‘(g) FUNDING.—There are authorized to be appro-
priated such sums as are necessary for purposes of making 
grants under this section for each of fiscal years 2020 
through 2029.’’. 
Passed the House of Representatives December 12, 
2019. 
Attest: 
Clerk.
116TH CONGRESS 
1ST SESSION 
H. R. 3 
AN ACT 
To establish a fair price negotiation program, pro-
tect the Medicare program from excessive price 
increases, and establish an out-of-pocket max-
imum for Medicare part D enrollees, and for 
other purposes.