104 
device to ensure the payment basis for such 
payment covers costs of the specified break-
through device are covered by such payment. 
‘‘(B) REPORT.— 
‘‘(i) IN
GENERAL.—With respect to 
each specified breakthrough device, the 
Secretary shall submit to Congress a re-
port on the coverage of and payment for 
such specified breakthrough device under 
this section that includes the following in-
formation: 
‘‘(I) The manner in which cov-
erage is provided and payment is 
made for the specified breakthrough 
device, including how such device was 
classified (such as an item of durable 
medical equipment or otherwise) and 
the payment methodology the Sec-
retary applied with respect to such de-
vice. 
‘‘(II) The impact of the avail-
ability of the specified breakthrough 
device to Medicare beneficiaries, in-
cluding impacts on the quality of pa-
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tient care, patient outcomes, and pa-
tient experience. 
‘‘(III) The impact of the avail-
ability of the specified breakthrough 
device to Medicare beneficiaries on 
program expenditures under this title. 
‘‘(IV) Such other information as 
the Secretary determines to be appro-
priate. 
‘‘(ii) DEADLINE.— 
‘‘(I) IN
GENERAL.—Except as 
provided in subclause (II), the Sec-
retary shall submit a report required 
under this subparagraph no later than 
the end of the transitional period of 
coverage and payment applicable to 
such specified breakthrough device. 
‘‘(II) EXTENSION TO GENERATE 
ADDITIONAL DATA.—If the Secretary 
determines that additional data or evi-
dence is required to complete a report 
required under this subparagraph 
with respect to a specified break-
through device, the deadline under 
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this clause may be extended for an 
additional two years. 
‘‘(C) ADDITIONAL
PERIOD
OF
TRANSI-
TIONAL
COVERAGE
TO
DEVELOP
ADDITIONAL 
DATA.—Insofar as the Secretary determines 
that additional data or evidence is required to 
complete a report required under subparagraph 
(B) with respect to a specified breakthrough de-
vice, the transitional coverage period of cov-
erage and payment for such device shall be ex-
tended by the lesser of— 
‘‘(i) two years; or 
‘‘(ii) the amount of additional time re-
quired for the submission of the report 
with respect to such device. 
‘‘(3) COVERAGE
AND
PAYMENT
AFTER
THE 
TRANSITIONAL
PERIOD.—The Secretary may con-
tinue to provide for coverage of and payment for a 
specified breakthrough device after the end of the 
transitional period of coverage and payment for 
breakthrough devices through the national coverage 
determination process if the Secretary determines 
that the specified breakthrough device— 
‘‘(A) improves the quality of care and pa-
tient outcomes; 
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‘‘(B) improves the delivery of care; or 
‘‘(C) reduces spending under this title 
without reducing the quality of care.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) INPATIENT
PROSPECTIVE
PAYMENT
SYS-
TEM.—Section 1886(d)(5)(K) of the Social Security 
Act (42 U.S.C. 1395ww(d)(5)(K)) is amended by 
adding at the end the following new clause: 
‘‘(x) Effective for discharges occurring on 
or after October 1, 2019, in the case of a new 
medical service or technology that is a break-
through 
device 
(as 
defined 
in 
section 
1899C(a)), the additional payment established 
for such breakthrough device under this sub-
paragraph shall be made for the 4-year period 
applicable to such breakthrough device under 
section 
1899C(d)(1). 
In 
determining 
the 
amount of the additional payment for a break-
through device under this subparagraph during 
such 4-year period, the Secretary shall apply 
section 412.88(b) of title 42, Code of Federal 
Regulations, as in effect on the date of the en-
actment of this clause, except as if the ref-
erence in such section to ‘65 percent’ were a 
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reference to ‘65 percent (or such greater per-
cent specified by the Secretary)’.’’. 
(2) OUTPATIENT PROSPECTIVE PAYMENT SYS-
TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 
1395l(t)(6)(C)) is amended by adding at the end the 
following new clause: 
‘‘(iii) SPECIAL
RULE
FOR
BREAK-
THROUGH
DEVICES.—Notwithstanding 
clause (i) or (ii), or any other provision of 
this paragraph to the contrary, in the case 
of a breakthrough device (as defined in 
section 1899C(a)) that is furnished on or 
after January 1, 2020, payment under this 
paragraph for such breakthrough device 
shall be made for the 4-year period appli-
cable to such breakthrough device under 
section 1899C(d)(2). The provisions of this 
clause shall also apply for purposes of 
transitional pass-through payment under 
section 1833(i)(2)(D).’’. 
(c) EFFECTIVE DATE.—This section, and the amend-
ments made by this section, shall take effect on the date 
of the enactment of this Act and, unless otherwise speci-
fied in this section (or in an amendment made by this sec-
tion), shall apply to breakthrough devices (as defined in 
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section 1899C(a) of the Social Security Act, as added by 
subsection (a)), approved or cleared on or after July 1, 
2019, or, in the case of a specified breakthrough device 
(as defined in such section as so added), approved or 
cleared on or after December 1, 2018. 
SEC. 405. SECRETARY OF HEALTH AND HUMAN SERVICES 
REPORT ON COVERAGE FOR INNOVATIVE 
TECHNOLOGIES. 
Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services, 
in collaboration with the Administrator of the Centers for 
Medicare & Medicaid Services, and following a request for 
information, shall submit to Congress a report containing 
a proposal that— 
(1) specifies, for purposes of payment and cov-
erage under title XVIII of the Social Security Act, 
a definition for digital alternatives to treatment and 
therapies, including wearables and digital applica-
tions and platforms; 
(2) establishes a standardized process for deter-
mining which technologies satisfy the definition pur-
suant to paragraph (1); 
(3) establishes a standardized process for deter-
mining coverage under such title of digital alter-
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natives as defined pursuant to paragraph (1) that 
are prescribed by a physician; and 
(4) identifies an innovative system for payment 
under such title for such alternatives. 
SEC. 406. SECRETARY OF HEALTH AND HUMAN SERVICES 
REPORT ON CMS COMPUTER SYSTEMS. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall submit to Congress a report on the fol-
lowing: 
(1) The current state of computer systems of 
the Centers for Medicare & Medicaid Services, in-
cluding an analysis of the capabilities and defi-
ciencies of such systems in helping to managing the 
operations of the programs administered by the Cen-
ters for Medicare & Medicaid Services. 
(2) The cost, taking into account ways to lower 
or defray costs to the Federal Government, of each 
of the following: 
(A) Replacing or updating such systems 
identified under paragraph (1). 
(B) Contractors and other third parties to 
solve for deficiencies in such system identified 
under paragraph (1). 
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SEC. 407. PRECISION MEDICINE ANSWERS FOR KIDS 
TODAY. 
(a) CENTERS FOR MEDICARE & MEDICAID SERVICES 
GUIDANCE ON THE EARLY AND PERIODIC SCREENING, 
DIAGNOSTIC, AND TREATMENT BENEFIT.—Not later than 
6 months after the date of the enactment of this Act, the 
Centers for Medicare & Medicaid Services shall issue guid-
ance to States on authority and requirements under the 
Medicaid program under title XIX of the Social Security 
Act to provide medically necessary health care that falls 
within the scope of services specified under section 
1905(r) of the Social Security Act (42 U.S.C. 1396d(r)) 
to a child, regardless of whether the service is available 
for adults under the State plan (or waiver of such plan) 
under such title. The guidance shall— 
(1) include technical and educational assistance 
on how to increase the frequency of coverage under 
the State plan (or waiver) pursuant to paragraphs 
(4) and (16) of section 1905(a) of such Act (42 
U.S.C. 1396d(a)) for genetic and genomic testing di-
agnostic services, including whole exome sequencing, 
whole genome sequencing, and gene panels when rec-
ommended by a qualified treating provider as a first- 
or second-tier test for pediatric patients, including 
those who— 
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(A) have a positive result from a newborn 
screening program; 
(B) have one or more neurodevelopmental 
or congenital anomalies; 
(C) are experiencing developmental delay 
or intellectual disability; 
(D) are having seizures; 
(E) have been referred or admitted to a 
pediatric or neonatal intensive care unit for a 
chronic or undiagnosed disease; 
(F) have been seen by at least one medical 
specialist for such chronic or undiagnosed dis-
ease; or 
(G) are suspected by at least one 
healthcare provider to have a neonatal- or pedi-
atric-onset genetic disease; 
(2) provide education and support to providers 
to minimize denials of claims for medical assistance 
under the State plan under title XIX of the Social 
Security Act resulting from deficient or inadequate 
paperwork; and 
(3) ensure that providers and Medicaid-eligible 
children and the families are aware of the Early and 
Periodic Screening, Diagnostic and Treatment Ben-
efit under title XIX of the Social Security Act and 
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have access to required screenings and necessary 
treatment services. 
(b) DEMONSTRATION PROGRAM TO PROVIDE GE-
NETIC
AND GENOMIC TESTING
FOR CERTAIN CHIL-
DREN.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall enter into agreements with up 
to 15 States submitting applications under para-
graph (3) for the purpose of conducting, in accord-
ance with this subsection, demonstration projects 
under section 1115 of the Social Security Act (42 
U.S.C. 1315) in such States during the 3-year pe-
riod beginning on the first date of the first fiscal 
quarter than begins on or after the date of the en-
actment of this subsection to test and evaluate the 
provision of medical assistance under the State plans 
under title XIX of such Act (or waivers of such 
plans) to eligible individuals for purposes of pro-
viding such individuals with genetic and genomic 
testing. 
(2) DEMONSTRATION
PROJECT
PAYMENT
RE-
QUIREMENTS.—Under each demonstration project 
under this section conducted by a State, the fol-
lowing shall apply: 
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(A) The State shall provide a health care 
provider (as defined by the State) with pay-
ments for the provision of genetic and genomic 
testing to any eligible individual. Payments 
made to a health care provider for such services 
shall be treated as medical assistance for pur-
poses of section 1903(a) of the Social Security 
Act (42 U.S.C. 1396b(a)), except that the Fed-
eral medical assistance percentage applicable to 
such payments shall be equal to 100 percent. 
(B) The State shall specify the method-
ology the State will use for determining pay-
ment for the provision of genetic and genomic 
testing. Such methodology for determining pay-
ment shall be established consistent with section 
1902(a)(30)(A) 
of 
such 
Act 
(42 
U.S.C. 
1396a(a)(30)(A)). 
(3) APPLICATIONS.— 
(A) IN
GENERAL.—A State desiring to 
enter into an agreement under paragraph (1) 
with the Secretary for conducting a demonstra-
tion project shall submit to the Secretary an 
application, in accordance with such form and 
manner, and application priorities, as specified 
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by the Secretary and that at a minimum in-
cludes the following: 
(i) An explanation of how and the ex-
tent to which genetic and genomic testing 
under the demonstration project of the 
State will provide information and data on 
how such services improve the diagnosis of 
eligible individuals. 
(ii) An explanation of how and the ex-
tent to which coverage under the State 
plan (or waiver) pursuant to the dem-
onstration project will increase the use of 
genetic and genomic testing that may in-
crease the use of genetic and genomic test-
ing that may improve clinical outcomes for 
eligible individuals. 
(iii) Procedures for referring any eligi-
ble individual who seeks or needs treat-
ment in a hospital emergency department 
to a health care provider who is qualified 
(as determined by the State) to provide ge-
netic and genomic testing. 
(iv) An explanation of how genetic 
and genomic testing may improve health 
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outcomes for all populations in the State, 
including— 
(I) individuals with a rare genetic 
disease, including a metabolic disease, 
neurologic disorders, or hereditary 
cancer testing in the presence of a 
suspected or confirmed cancer diag-
nosis; and 
(II) special populations, including 
infants and children who are critically 
ill (non-infectious and non-trauma) 
patients, transplant patients, individ-
uals with cardiac disease, and individ-
uals with, or who have a family his-
tory of, a birth defect or develop-
mental disability. 
(B) PREFERENCES
IN
CONSIDERING
AP-
PLICATIONS.—In considering applications sub-
mitted under subparagraph (A), the Secretary 
of Health and Human Services shall give pref-
erence to States that can demonstrate under-
utilization of genetic and genomic sequencing 
clinical services (with priority given to States 
that do not cover whole-genome sequencing or 
do not cover the majority of genetic and 
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genomic clinical services) in pediatric popu-
lations under the State plan under title XIX of 
the Social Security Act (or waiver of such 
plan). 
(4) TECHNICAL ASSISTANCE.—The Secretary of 
Health and Human Services shall provide technical 
assistance to assist States in planning and designing 
the demonstration project for purposes of applying 
for conducting such project under this section. 
(5) REPORTS BY STATES.—Not later than one 
year after the date on which a State enters into an 
agreement under paragraph (1) with the Secretary 
for conducting a demonstration project, the State 
shall submit a report to the Administrator of the 
Centers for Medicare & Medicaid Services and the 
Administrator of the Health Resources and Services 
Administration on the extent to which genetic and 
genomic testing improved outcomes and reduced 
health disparities. Such report shall include informa-
tion on the number of patients receiving genetic and 
genomic testing, the types of services provided, and 
such other information as the Secretary shall pre-
scribe. 
(6) REPORTS BY HEALTH CARE PROVIDERS.— 
As a condition for receiving payment for genetic and 
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genomic testing provided to an eligible individual 
under a demonstration project conducted by a State 
under this subsection, a health care provider shall 
report to the State, in accordance with such require-
ments as the Secretary shall specify, on all applica-
ble measures for determining the quality and effi-
cacy of such services. 
(7) DEFINITIONS.—In this subsection: 
(A) ELIGIBLE INDIVIDUAL.—The term ‘‘el-
igible individual’’ means, with respect to a 
State, an individual who— 
(i) is eligible for medical assistance 
under the State plan under title XIX of 
the Social Security Act (or a waiver of 
such plan); 
(ii) is under the age of 21 (or, at the 
option of the State, under the age of 20, 
19, or 18 as the State may choose), or in 
the case of an individual described in sec-
tion 1902(a)(10)(A)(i)(IX) of such Act (42 
U.S.C. 1396a(a)(10)(A)(i)(IX)), under the 
age of 26; 
(iii) has been referred or admitted to 
an intensive care unit, or has been seen by 
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at least one medical specialist, for a sus-
pected genetic or undiagnosed disease; or 
(iv) is suspected by at least one med-
ical specialist to have a neonatal-onset or 
pediatric-onset genetic disease. 
(B) GENETIC
AND
GENOMIC
TESTING.— 
The term ‘‘genetic and genomic testing’’, with 
respect to an eligible individual— 
(i) means the determination of a se-
quence of deoxyribonucleic acid bases in 
the genome of such individual, and, if for 
the sole benefit of the individual, a biologi-
cal parent of such individual for the pur-
pose of determining whether one or more 
potentially disease-causing genetic variants 
are present in the genome of such indi-
vidual or such biological parent; and 
(ii) includes— 
(I) the sequencing of the whole 
genome, the whole exome, or a panel 
of genes; and 
(II) any analysis, interpretation, 
and data report derived from such se-
quencing. 
(c) NATIONAL ACADEMY OF MEDICINE STUDY.— 
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(1) IN
GENERAL.—Not later than one year 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall enter 
into an arrangement with the National Academy of 
Medicine under which the Academy agrees to 
study— 
(A) how genetic and genomic testing may 
improve preventative care and precision medi-
cine; 
(B) disparities in access to precision 
diagnostics and associated therapeutics; 
(C) how genetic and genomic testing may 
be used to reduce health disparities in 
marginalized communities; 
(D) how the Federal Government may help 
to reduce barriers to genetic and genomic test-
ing, including— 
(i) encouraging the expansion of 
health insurance coverage of genetic and 
genomic testing, including diagnostic, pre-
dictive, and presymptomatic testing, and 
genetic and genomic testing (as defined in 
subsection (b)(7)(B)); 
(ii) supporting the collection of evi-
dence for the clinical utility and appro-
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priate use of genetic and genomic tests; 
and 
(iii) improving access to genetic coun-
selors, pathologists, and other relevant pro-
fessions, including strengthening related 
workforce education and training efforts; 
(E)(i) the extent to which coverage provi-
sions in the Medicare and Medicaid programs 
under titles XVIII and XIX of the Social Secu-
rity Act (42 U.S.C. 1395 et seq., 1396 et seq.) 
may restrain the use of genetic and genomic 
testing that may improve clinical outcomes for 
beneficiaries; 
(ii) the extent to which coverage provided 
pursuant to subsection (a) increased the use of 
genetic and genomic testing and improved clin-
ical outcomes for beneficiaries; and 
(iii) how the Centers for Medicare & Med-
icaid Services may make coverage determina-
tions that better suit a precision medicine ap-
proach to treatment; and 
(F) how genetic and genomic testing may 
improve health outcomes for all pediatric popu-
lations in the United States, including— 
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(i) children with a rare disease, in-
cluding a metabolic disease, neurologic dis-
order, or hereditary cancer testing in the 
presence of a suspected or confirmed can-
cer diagnosis; and 
(ii) special populations, including— 
(I) critically ill (non-infectious 
and non-trauma) patients; 
(II) transplant patients; 
(III) individuals with cardiac dis-
ease; and 
(IV) individuals with, or who 
have a family history of, a birth defect 
or developmental disability. 
(2) REPORT.— 
(A) 
IN
GENERAL.—The 
arrangement 
under paragraph (1) shall provide for the Na-
tional Academy of Medicine to submit, not later 
than 2 years after the date of the enactment of 
this Act, a report on the results of the study 
under paragraph (1) to— 
(i) the Secretary of Health and 
Human Services; 
(ii) the Committee on Ways and 
Means and the Committee on Energy and 
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Commerce of the House of Representa-
tives; and 
(iii) the Committee on Finance and 
the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(B) CONSULTATION.—The arrangement 
under paragraph (1) shall provide for the Na-
tional Academy of Medicine, in developing the 
report required by subparagraph (A), to consult 
with physicians, other health professionals, 
health educators, health professional organiza-
tions, relevant companies, patients, patient or-
ganizations, the Health Resources and Services 
Administration, the National Cancer Institute, 
the National Institutes of Health, the Agency 
for Healthcare Research and Quality, and the 
Centers for Medicare & Medicaid Services. 
(C) USE OF INFORMATION.—The National 
Academy of Medicine shall, to the extent pos-
sible, in conducting the study under paragraph 
(1), utilize information included in the reports 
submitted pursuant to subsections (f) and (g) 
of section 2. 
(d) CENTERS FOR MEDICARE & MEDICAID SERVICES 
REPORT ON MEDICAID COVERAGE FOR GENETIC AND 
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GENOMIC TESTING.—Not later than one year after the 
date of the enactment of this Act, and annually thereafter 
for the subsequent 3 years, the Centers for Medicare & 
Medicaid Services shall submit to the Secretary of Health 
and Human Services, the Committees on Ways and Means 
and on Energy and Commerce of the House of Represent-
atives, and the Committees on Finance and Health, Edu-
cation, Labor, and Pensions of the Senate a report on the 
extent to which each of the 50 States provide coverage 
under the State plan under title XIX of the Social Secu-
rity Act (or waiver of such plan) of genetic and genomic 
testing (as defined in subsection (b)(7)(B)) (including 
whole exome, whole genome, gene panels, single gene tests, 
Chromosomal microarray analysis, Fluorescence in situ 
hybridization, and other genetic and genomic tests), in-
cluding information on— 
(1) how often genetic and genomic diagnostic 
testing services are covered and reimbursed; 
(2) the frequency of denials for coverage and 
the rationale for denying coverage; 
(3) an analysis of which genetic and genomic 
diagnostic tests are being approved or denied; 
(4) how often test genetic counseling is covered 
pre- and post-genetic and genomic diagnostic test-
ing; 
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(5) the turn-around time for prior authorization 
requests; and 
(6) any barriers to coverage of genetic and 
genomic testing services identified. 
SEC. 408. MEDICARE COVERAGE FOR CONSULTATIONS. 
(a) INCLUSION OF CONSULTATIONS AS A MEDICARE 
BENEFIT.—Section 1861 of the Social Security Act (42 
U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (GG); 
(B) by striking the period at the end of 
subparagraph (HH) and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(II) pharmacogenetic consultations pro-
vided by a qualified clinical pharmacist, genetic 
counselor, or pathologist (as such terms are de-
fined in subsection (lll)).’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(lll) DEFINITIONS.—In this section: 
‘‘(1) PHARMACOGENETIC CONSULTATION.—The 
term ‘pharmacogenetic consultation’ means, with re-
spect to a genetic or genomic test furnished to an 
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individual, a consultation with respect to such test 
requested by the physician treating such individual 
to provide such physician with advice and rec-
ommendations regarding the dosage, safety, and effi-
cacy of particular drugs, biologicals, and other treat-
ments based on the individual’s pharmacogenetic re-
sult. 
‘‘(2) GENETIC COUNSELOR.—The term ‘genetic 
counselor’ means an individual who— 
‘‘(A) is licensed as a genetic counselor by 
the State in which the individual furnishes ge-
netic counseling services; or 
‘‘(B) in the case of an individual practicing 
in a State that does not license genetic coun-
selors, meets such other criteria as the Sec-
retary establishes. 
‘‘(3) QUALIFIED CLINICAL PHARMACIST.—The 
term ‘qualified clinical pharmacist’ means an indi-
vidual— 
‘‘(A) with a doctoral degree in pharmacy; 
‘‘(B) who is licensed as a pharmacist in 
the State in which such individual furnishes 
consultations; 
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127 
‘‘(C) has appropriate pharmacy specialty 
certifications or appropriate training, as deter-
mined by the Secretary; and 
‘‘(D) meets other qualifications as specified 
by the Secretary.’’. 
(b) PAYMENT FOR PHARMACOGENETIC CONSULTA-
TION.—Section 1832(a)(2) of the Social Security Act (42 
U.S.C. 1395k(a)(2)) is amended— 
(1) by striking ‘‘and’’ at the end of subpara-
graph (I); 
(2) by striking the period at the end of sub-
paragraph (J) and inserting ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(K) pharmacogenetic consultations (as 
defined in subsection (lll)).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall apply to consultations fur-
nished during a cost reporting period beginning on or after 
the date of the enactment of such subsections. 
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SEC. 409. PROHIBITING THE USE OF GEOGRAPHIC TRACK-
ING FEATURES AND BIOMETRICS WITHIN 
MEDICAID ELECTRONIC VISIT VERIFICATION 
SYSTEMS. 
(a) IN GENERAL.—Section 1903(l)(5)(A) of the So-
cial Security Act (42 U.S.C. 1396b(l)(5)(A)) is amended 
by inserting ‘‘(without the use of geographic tracking or 
biometrics)’’ after ‘‘electronically verified’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to calendar quar-
ters beginning on or after June 1, 2022. 
SEC. 410. GENERALLY ACCEPTED STANDARD FOR ELEC-
TRONIC PRESCRIBING. 
Section 1860D–4(e) of the Social Security Act (42 
U.S.C. 1395w–104(e)) is amended by adding at the end 
the following new paragraph: 
‘‘(8) GENERALLY ACCEPTED STANDARDS.— 
‘‘(A) DESIGNATION OF STANDARDS MAIN-
TENANCE ORGANIZATION TO RECOGNIZE GEN-
ERALLY
ACCEPTED
STANDARDS.—Not later 
than 6 months after the date of the enactment 
of this paragraph, the Secretary shall designate 
through rulemaking a standards maintenance 
organization with the authority to establish, 
maintain, and modify generally accepted stand-
ards for electronic prescribing and electronic 
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129 
prior authorization. The standards maintenance 
organization named by the Secretary shall be a 
standard setting body that— 
‘‘(i) is a not-for-profit; 
‘‘(ii) has established a multi-stake-
holder forum for development and approval 
of electronic prescribing and electronic 
prior authorization standards; 
‘‘(iii) is a standards development or-
ganization accredited by the American Na-
tional Standards Institute; and 
‘‘(iv) includes in its membership phar-
macies, 
prescribers, 
prescription 
drug 
plans, health information technology devel-
opers, and representatives from the Cen-
ters for Medicare & Medicaid Services and 
the Food and Drug Administration. 
In providing the standards maintenance organi-
zation with the authority to establish, maintain, 
and modify generally accepted standards, the 
Secretary shall permit the standards mainte-
nance organization to recognize up to two 
versions of a standard as being generally ac-
cepted to facilitate the testing of newer stand-
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130 
ards and to allow a smooth transition from one 
standard to another. 
‘‘(B) ADOPTION OF GENERALLY ACCEPTED 
STANDARDS.—Not later than six months after 
making the designation under paragraph (8), 
the Secretary shall require prescriptions and 
other 
information 
described 
in 
paragraph 
(2)(A) for covered Part D drugs prescribed for 
Part D eligible individuals that are transmitted 
electronically to be transmitted only in accord-
ance with generally accepted standards, as des-
ignated by the standards maintenance organiza-
tion named by the Secretary under subpara-
graph (A), under an electronic prescription 
drug program that meets the requirements of 
paragraph (2).’’. 
SEC. 411. MEANINGFUL ACCESS TO FEDERAL HEALTH 
PLAN CLAIMS DATA. 
(a) FINDINGS.—Congress finds as follows: 
(1) Clinician-led clinical data registries serve an 
important role in promoting, facilitating, and con-
ducting medical research and improving quality of 
healthcare by providing timely and actionable feed-
back to practitioners on their performance in rela-
tion to other practitioners and best clinical practices. 
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(2) Clinician-led clinical data registries are hin-
dered in their ability to promote medical research 
and quality improvement by their lack of meaningful 
access to claims data. 
(3) While the Centers for Medicare & Medicaid 
Services has established programs for providing ac-
cess to claims data, those programs fail to provide 
clinician-led clinical data registries with meaningful 
access to such data. 
(4) Ensuring clinician-led clinical data reg-
istries meaningful access to claims data will enable 
such entities to better track patient outcomes over 
time, expand their ability to assess the safety and ef-
fectiveness of medical treatments, and provide them 
with the information necessary to assess the cost-ef-
fectiveness of therapies. 
(b) ENSURING MEANINGFUL ACCESS
TO CLAIMS 
DATA.— 
(1) ESTABLISHMENT OF A NEW PROGRAM.— 
The Secretary shall establish a new program (sepa-
rate from any existing data access programs, includ-
ing, without limitation, the Centers for Medicare & 
Medicaid Services Qualified Entity (in this section, 
referred 
to 
as 
‘‘QE’’) 
Program 
(42 
U.S.C. 
1395kk(e), 1395kk–2) (in this section, referred to as 
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132 
the ‘‘Medicare Data Sharing for Performance Meas-
urement Program’’) and the Research Data Assist-
ance Center (in this section, referred to as the 
‘‘ResDAC’’) process) under which the Secretary 
shall, at the request of a clinician-led clinical data 
registry, provide timely, broad, and continuous ac-
cess to a database of claims data to such clinician- 
led clinical data registry for purposes of research, 
quality of care measurement and reporting to health 
care providers, linking such data with clinical data 
and performing risk-adjusted, scientifically valid 
analyses and research to support quality improve-
ment or patient safety, and other purposes and uses 
described herein or approved by the Secretary. Ac-
cess to a database of claims data pursuant to this 
subsection shall not be more restrictive than access 
to data provided under the QE Program or the 
ResDAC process. 
(2) STREAMLINED APPLICATION PROCESS.— 
(A) INITIAL AND RECERTIFICATION APPLI-
CATION.—Prior to gaining access to a database 
of claims data under the program established in 
subsection (a), a clinician-led clinical data reg-
istry shall submit to the Secretary an applica-
tion demonstrating that it is qualified (as deter-
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(A) OPPORTUNITY TO APPEAL.—The Sec-
retary shall develop and maintain a process by 
which a clinician-led clinical data registry may 
appeal— 
(i) the Secretary’s decision to deny an 
application described in paragraph (2); and 
(ii) the Secretary’s failure to approve 
or deny the clinician-led clinical data reg-
istry’s application described in paragraph 
(2) within a reasonable time frame estab-
lished by the Secretary. 
(B) DEADLINE FOR DECISION.—The Sec-
retary shall render a decision with respect to an 
appeal filed by a clinician-led clinical data reg-
istry pursuant to subparagraph (A) in a timely 
manner, not to exceed 60 calendar days after 
the Secretary receives the clinician-led clinical 
data registry’s request for an appeal. Notice of 
such decision shall be provided to the clinician- 
led clinical data registry filing the appeal before 
the conclusion of such 60-day period. 
(4) BROAD AND TIMELY ACCESS TO DATA.— 
The Secretary shall structure its database of claims 
data to allow for various data set queries, including, 
but not limited to, provider-specific claims data, clin-
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135 
ical specialty-specific claims data, state-specific 
claims data, and nationwide claims data. The Sec-
retary shall promptly make available to a clinician- 
led clinical data registry access to claims data re-
quested by such clinician-led clinical data registry 
within a reasonable timeframe, not to exceed 30 cal-
endar days, after the Secretary approves the request 
from the clinician-led clinical data registry. 
(c) PERMISSIBLE USES OF CLAIMS DATA.—Clini-
cian-led clinical data registries may— 
(1) make available to the public reports evalu-
ating the performance of providers of services and 
suppliers using the claims data provided to such cli-
nician-led clinical data registry under subsection (a) 
in combination with registry data; 
(2) use claims data received under subsection 
(a) combined with registry data to conduct addi-
tional nonpublic analyses and provide or charge an 
access fee for such analyses to authorized users for 
nonpublic use; 
(3) provide or charge an access fee for data sets 
that link claims data received under subsection (a) 
with registry data to authorized users for nonpublic 
use; and 
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136 
(4) provide or charge an access fee for claims 
data received under subsection (a) to authorized 
users for nonpublic use. 
(d) FEES.— 
(1) CLAIMS DATA PROVIDED TO CLINICIAN-LED 
CLINICAL DATA REGISTRIES.—Claims data shall be 
provided to a clinician-led clinical data registry 
under subsection (a) at a reasonable fee based on 
the cost of providing such data to the clinician-led 
clinical data registry. Such fee shall be based at 
least in part on the number of patients included in 
the claims data provided to such clinician-led clinical 
data registry. Any fee collected pursuant to the pre-
ceding sentences shall be deposited in the Centers 
for Medicare & Medicaid Services Program Manage-
ment Account. 
(2) ANALYSES
AND
DATA
PROVIDED
TO
AU-
THORIZED USERS.—A clinician-led clinical data reg-
istry may charge a reasonable, cost-based fee for 
providing to authorized users claims data, data sets 
linking claims data with registry data, or analyses 
described in subsection (b). 
(e) PROTECTION OF INFORMATION.— 
(1) PRIVACY, 
SECURITY, 
AND
DISCLOSURE 
LAWS.—The Secretary shall provide access to a 
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database of claims data pursuant to subsection (a) 
in accordance with applicable information, privacy, 
security, and disclosure laws, including, without limi-
tation, the Health Insurance Portability and Ac-
countability Act of 1996 (Public Law 104–191) as 
amended by the privacy and security provisions set 
forth in section 13400 of the Health Information 
Technology for Economic and Clinical Health Act 
(Public Law 111–5), the regulations promulgated 
thereunder codified at parts 160 and 164 of title 45, 
Code of Federal Regulations, and subparagraphs (A) 
through (B) of section 105(a)(3) of the Medicare 
Access and CHIP Reauthorization Act of 2015 (42 
U.S.C. 1395kk–2(a)(3)). 
(2) PROHIBITION ON USING ANALYSES OR DATA 
FOR
MARKETING
PURPOSES.—An authorized user 
shall not use analyses or data provided or sold under 
paragraphs (2) through (4) of subsection (b) for 
marketing purposes. 
(3) NO
REDISCLOSURE
OF
ANALYSES
OR 
DATA.—An authorized user in receipt of an analysis 
or datum provided or sold under paragraphs (2) 
through (4) of subsection (b) shall comply with sec-
tion 105(a)(5) of Medicare Access and CHIP Reau-
thorization Act of 2015 (42 U.S.C. 1395kk–2(a)(5)). 
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(4) OPPORTUNITY FOR PROVIDERS OF SERV-
ICES AND SUPPLIERS TO REVIEW.—Prior to a clini-
cian-led clinical data registry using, providing, or 
charging an access fee for claims data, data sets 
linking claims data with registry data, or analyses 
described in subsection (b), to the extent that such 
data, data sets, or analyses would individually iden-
tify a provider of services or supplier who is not 
being provided or sold such data, data sets, or anal-
yses, such clinician-led clinical data registry shall 
confidentially make available such data, data sets, or 
analyses to such provider of services or supplier and 
provide such provider of services or supplier with the 
opportunity to appeal and correct errors. 
(f) DATA USE AGREEMENT.—A clinician-led clinical 
data registry and an authorized user shall enter into a 
data use agreement regarding the use or disclosure of any 
claims data or data sets that link claims data with registry 
data that the clinician-led clinical data registry is pro-
viding or charging an access fee to the authorized user 
under paragraphs (3) through (4) of subsection (b). Such 
agreement shall include the requirements and prohibitions 
described in section 105(a)(4) of the Medicare Access and 
CHIP Reauthorization Act of 2015 (42 U.S.C. 1395kk– 
2(a)(4)). 
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139 
(g) ASSESSMENT FOR A BREACH.— 
(1) IN GENERAL.—In the case of a breach of a 
data use agreement described in subsection (e), the 
Secretary shall impose an assessment on the clini-
cian-led clinical data registry and the authorized 
user. 
(2) ASSESSMENT.—The assessment under para-
graph (1) shall be in an amount up to $100 for each 
individual entitled to, or enrolled for, benefits under 
part A of title XVIII of the Social Security Act or 
enrolled for benefits under part B of such title for 
whom the clinician-led clinical data registry provided 
data on to the authorized user. 
(3) DEPOSIT OF AMOUNTS COLLECTED.—Any 
amounts collected pursuant to this subsection shall 
be deposited in the Federal Supplementary Medical 
Insurance Trust Fund under section 1841 of the So-
cial Security Act (42 U.S.C. 1395t). 
(h) DISCOVERY
OR ADMISSION
AS EVIDENCE.— 
Claims data released to a clinician-led clinical data reg-
istry under subsection (a) shall not be subject to discovery 
or admission as evidence in judicial or administrative pro-
ceedings without consent of the applicable provider of 
services or supplier. 
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(i) REPORT TO CONGRESS.—Not later than 2 years 
after the date of the enactment of this Act, and annually 
thereafter, the Secretary shall submit to Congress a report 
on the extent to which clinician-led clinical data registries 
are afforded meaningful access to claims data. 
(j) DEFINITIONS.—In this subtitle: 
(1) AUTHORIZED USER.—The term ‘‘authorized 
user’’ has the meaning given such term in section 
105(a)(9)(A) of the Medicare Access and CHIP Re-
authorization Act of 2015 (42 U.S.C. 1395kk– 
2(a)(9)(A)), as well as a government agency or other 
governmental entity, researchers, entities that seek 
data for purposes of complying with regulations or 
other requirements of the Federal Food and Drug 
Administration, and other entities approved by the 
Secretary. 
(2) CLAIMS
DATA.—The term ‘‘claims data’’ 
has the meaning given to the term ‘‘data’’ in section 
105(b)(1)(B) of the Medicare Access and CHIP Re-
authorization Act of 2015 (42 U.S.C. 1395kk– 
2(b)(1)(B)). 
(3) 
CLINICIAN-LED
CLINICAL
DATA
REG-
ISTRY.—The term ‘‘clinician-led clinical data reg-
istry’’ has the meaning given such term in section 
4005(b) of the 21st Century Cures Act. 
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(4) NONPUBLIC
USE.—The term ‘‘nonpublic 
use’’ means a use for the purpose of— 
(A) promoting, facilitating, and conducting 
medical research, assisting providers of services 
and suppliers to improve patient safety, and to 
develop and participate in quality and patient 
care improvement activities, including devel-
oping new models of care; 
(B) assisting clinician-led clinical data reg-
istries in developing and reporting quality meas-
ures to health care providers quality measures; 
(C) educating a government agency or 
other governmental entity; and 
(D) supporting clinical trials and other ac-
tivities necessary to comply with pre- or post- 
market approval or adverse event reporting re-
quirements or conditions imposed by the Food 
and Drug Administration, and other purpose 
approved by the Secretary. 
(5) PROVIDER OF SERVICES.—The term ‘‘pro-
vider of services’’ has the meaning given such term 
in section 1861(u) of the Social Security Act (42 
U.S.C. 1395x(u)). 
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142 
(6) SUPPLIER.—The term ‘‘supplier’’ has the 
meaning given such term in section 1861(d) of the 
Social Security Act (42 U.S.C. 1395x(d)). 
(k) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall promulgate final regulations to 
implement the provisions of the preceding sections of this 
subtitle. 
TITLE V—RESEARCH 
SEC. 501. ADVANCED RESEARCH PROJECTS AGENCY FOR 
HEALTH. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services, acting through the Director of the Na-
tional Institutes of Health, shall establish the Advanced 
Research Projects Agency for Health (to be referred to 
in this Act as ‘‘ARPA–H’’) to transform and improve im-
portant areas of medicine and health for the well-being 
of all individuals in the United States. 
(b) GOALS.— 
(1) IN GENERAL.—The goals of ARPA–H shall 
be to deliver breakthrough capabilities through tech-
nologies, systems, and platforms that— 
(A) accelerate the discovery and applica-
tion of transformational innovations in health 
and medical product development; and 
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143 
(B) reduce the human and economic cost 
of disease. 
(2) MEANS.—ARPA–H may achieve the estab-
lished goals under paragraph (1), including by any 
of the following means: 
(A) Promoting high-risk, high-reward inno-
vation. 
(B) Identifying and promoting revolu-
tionary advances in biomedical and health re-
search that enable new paradigms in health. 
(C) Accelerating transformational health 
advances in areas that the relevant industries 
by themselves are not likely to undertake be-
cause of technical, financial, or other uncer-
tainty. 
(D) Prioritizing project investments based 
on scientific opportunity and uniqueness of fit 
to ARPA–H strategies and operating practice, 
together with the prospective impact on disease 
burden (regardless of disease prevalence), both 
human and fiscal, including the health care fis-
cal liability of the Federal government. 
(E) Partnering with, and providing fund-
ing to, a broad range of institutions, including 
universities, national laboratories, public sector 
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144 
organizations, private companies, nonprofit or-
ganizations, and foreign institutions. 
(c) DIRECTOR.— 
(1) IN GENERAL.— ARPA–H shall be headed 
by a Director, who shall be appointed by and serve 
at the pleasure of the President (referred to in this 
section as the ‘‘Director of ARPA–H’’). 
(2) SELECTION.—The Director of ARPA–H 
shall— 
(A) be an individual who, by reason of pro-
fessional background and experience, is quali-
fied to advise the Secretary on, and manage re-
search programs addressing, matters pertaining 
to long-term and high-risk barriers to the devel-
opment of health innovation; 
(B) have authority to execute contracts de-
veloped by in-house program managers who se-
lect external performers, and maintain, enhance 
or terminate projects based on performance 
against explicit milestones; and 
(C) have a time-limited appointment of 5 
years with the opportunity, at the discretion of 
the President, of one extension. 
(3) DUTIES.—The duties of the Director of 
ARPA–H shall be to— 
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(A) set national research priorities to ad-
vance the mission of the agency as informed by 
a multi-sectoral board of advisors; 
(B) approve all new programs within 
ARPA–H; 
(C) have final funding authority to initiate 
and terminate program funding; 
(D) establish criteria for funding and as-
sessing the success of programs through the es-
tablishment of technical milestones; 
(E) appoint the personnel necessary, con-
sistent with subsection (d), to successfully exe-
cute the goals of ARPA–H; and 
(F) designate employees to serve as pro-
gram managers to carry out the duties de-
scribed in subsection (e) for each of the pro-
grams established pursuant to the responsibil-
ities established for ARPA–H. 
(4) AUTHORITY.—The Director of ARPA–H is 
authorized to— 
(A) acquire (by purchase, lease, condemna-
tion, or otherwise), construct, improve, repair, 
operate, and maintain such real and personal 
property as are necessary to carry out this sec-
tion; and 
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146 
(B) lease an interest in property for not 
more than 20 years, notwithstanding section 
1341(a)(1) of title 31, United States Code. 
(d) PERSONNEL MANAGEMENT AUTHORITY.— 
(1) SPECIAL
PERSONNEL
MANAGEMENT
AU-
THORITY.—The Director of ARPA–H may— 
(A) make appointments to positions of ad-
ministration or management of ARPA–H with-
out regard to any provision in title 5, United 
States Code, governing appointments under the 
civil service laws and fix the compensation of 
such positions at a rate not to exceed the 
amount of annual compensation (excluding ex-
penses) specified in section 102 of title 3, 
United States Code, notwithstanding section 
202 of Department of Health and Human Serv-
ices Appropriations Act, 1993 (Public Law 
102–394); 
(B) hire personnel under section 207(f) of 
the Public Health Service Act (42 U.S.C. 
209(f)) and establish governing criteria to re-
cruit, appoint, and compensate personnel under 
this section notwithstanding section 202 of De-
partment of Health and Human Services Ap-
propriations Act, 1993 (Public Law 102–394) 
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or any provision of title 5, United States Code, 
governing the rates of pay or classification of 
employees in the Executive branch; 
(C) make additional appointments of sci-
entific, medical, and professional personnel 
under this section without regard to any provi-
sion in title 5, United States Code, governing 
appointments under the civil service laws and 
fix the compensation of such personnel at a rate 
to be determined by the Director, up to the 
amount of annual compensation (excluding ex-
penses) specified in section 102 of title 3, 
United States Code, notwithstanding section 
202 of Department of Health and Human Serv-
ices Appropriations Act, 1993 (Public Law 
102–394) or any provision of title 5, United 
States Code, governing the rates of pay or clas-
sification of employees in the Executive branch; 
and 
(D) recruit and retain a diverse workforce, 
including 
individuals 
underrepresented 
in 
science and medicine and racial and ethnic mi-
norities. 
(2) ADDITIONAL
STAFF.—The Director of 
ARPA–H may use all authorities in existence on the 
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148 
date of enactment of this Act that are provided to 
the Secretary to hire administrative, financial, infor-
mation technology staff, and any other staff the Di-
rector of ARPA–H determines are necessary to 
carry out this section. 
(3) LIMITATION ON TERM.— 
(A) IN GENERAL.—Except as provided in 
subparagraph (B), the service of an employee 
under an appointment under paragraph (1)(A) 
in the position of a program manager may not 
exceed 3 years. 
(B) EXTENSION.—The Director of ARPA– 
H may, in the case of a particular employee, ex-
tend the period to which service is limited under 
subparagraph (A) by up to 3 years if the Direc-
tor determines that such action is necessary to 
promote the efficiency of ARPA–H. 
(4) LIMITATION ON ADDITIONAL PAYMENTS.— 
The total amount of the additional payments paid to 
an employee under paragraph (1)(C) for any 12- 
month period may not exceed the least of the fol-
lowing amounts: 
(A) $25,000. 
(B) The amount equal to 25 percent of the 
employee’s annual rate of basic pay. 
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(C) The amount of the limitation that is 
applicable for a calendar year under section 
5307(a)(1) of title 5, United States Code. 
(e) PROGRAM MANAGERS.—An employee designated 
as a program manager pursuant to subsection (c)(3)(F) 
shall— 
(1) define the research and development goals 
and milestones of the program involved, in line with 
guidance from the Director; 
(2) track progress and course-correct projects 
when needed; 
(3) recommend, as necessary, the restructuring 
or termination of projects supported by ARPA–H; 
and 
(4) select, on the basis of merit and need, each 
of the projects to be supported under the program 
involved after considering— 
(A) the novelty and scientific and technical 
merit of the proposed projects; 
(B) the demonstrated capabilities of the 
applicants to successfully carry out the pro-
posed project; 
(C) the consideration by the applicant of 
future commercial applications of the project; 
or 
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(D) the unmet need within patient popu-
lations. 
(f) REPORTS.— 
(1) STRATEGIC
VISION.—Not later than 180 
days after the date of the enactment of this Act, the 
Director of ARPA–H shall provide to the Committee 
on Energy and Commerce and the Committee on 
Appropriations of the House of Representatives and 
the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of 
the Senate a report describing the strategic vision 
that ARPA–H will use to guide the choices of 
ARPA–H for future health investments over the fol-
lowing 3 fiscal years beginning on or after the date 
of the enactment of this Act. 
(2) ANNUAL
BUDGET
REQUEST.—As part of 
the annual budget request submitted for each fiscal 
year, the Director of ARPA–H shall provide to the 
congressional committees specified in paragraph (1) 
a report describing— 
(A) projects supported by ARPA–H during 
the previous fiscal year, including— 
(i) the transition of projects’ outcomes 
to clinical practice; 
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(ii) the impact on clinical outcome; 
and 
(iii) the creation of biomedical capa-
bilities; and 
(B) successes and barriers to scientific 
interchanges; 
(C) rapid knowledge transfer; 
(D) resource optimization; and 
(E) heightened investment impact among 
collaborators. 
(3) REPORT
ON
COOPERATIVE
AGREEMENTS 
AND OTHER TRANSACTION.—Not later than 90 days 
after the end of each fiscal year, the Director of 
ARPA–H shall submit to the congressional commit-
tees specified in paragraph (1) a report on all coop-
erative agreements and other transactions (other 
than contracts and grants) entered into under this 
subsection during such fiscal year. The report shall 
contain, with respect to such cooperative agreement 
and transaction, the following: 
(A) A general description of the coopera-
tive agreement or other transaction (as the case 
may be), including the innovations for which 
advanced research is provided for under such 
agreement or transaction. 
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(B) The potential clinical and, if any, com-
mercial utility of such innovations. 
(C) The reasons for not using a contract 
or grant to provide support for such advanced 
research. 
(D) The amount of the payments, if any, 
referred to in subsection (i)(2) that were re-
ceived by the Federal Government in connection 
with such cooperative agreement or other trans-
action during the fiscal year covered by the re-
port. 
(E) The amount of the payments reported 
under subparagraph (D), if any, that were cred-
ited to the account established under subsection 
(i)(7). 
(g) COORDINATION AND NONDUPLICATION.— 
(1) IN GENERAL.—The Director of ARPA–H 
shall ensure effective, early, and frequent coordina-
tion between ARPA–H and the heads of the re-
search, public health, and regulatory agencies of the 
Department of Health and Human Services, includ-
ing— 
(A) the Director of the National Institutes 
of Health; 
(B) the Commissioner of Food and Drugs; 
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(C) the Administrator of the Centers for 
Medicare & Medicaid Services; 
(D) the Director of the Centers for Disease 
Control and Prevention; and 
(E) the Assistant Secretary for Prepared-
ness and Response. 
(F) The Director of the National Science 
Foundation. 
(G) The Director of the Office of Science 
of the Department of Energy. 
(2) COORDINATION.—The Director shall also 
coordinate among the full set of advanced research 
project agencies including— 
(A) 
the 
Defense 
Advanced 
Research 
Project Agency; 
(B) the Advanced Research Project Agen-
cy-Energy; and 
(C) others as they may be established. 
(h) ADVICE.— 
(1) IN GENERAL.—The Director of ARPA–H 
may seek advice on any aspect of ARPA–H from— 
(A) any advisory committee that, as of the 
date of the enactment of this Act, is providing 
advice to the Secretary of Health and Human 
Services (or any head of a research, public 
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health, or regulatory agency of the Department 
of Health and Human Services); and 
(B) an advisory committee established on 
or after such date of the enactment to support 
the programs of ARPA–H and to provide advice 
and assistance on— 
(i) specific program tasks; or 
(ii) overall direction of ARPA–H. 
(2) ADDITIONAL SOURCES.—In addition to the 
advisory committees specified in paragraph (1), the 
Director of ARPA–H may seek advice and review 
from— 
(A) the President’s Committee of Advisors 
on Science and Technology; 
(B) any professional or scientific organiza-
tion with expertise in specific processes or tech-
nologies under development by ARPA–H; and 
(C) representatives of patient communities. 
(i) COOPERATIVE AGREEMENTS AND OTHER TRANS-
ACTIONS.— 
(1) IN GENERAL.—The Director of ARPA–H, 
in carrying out advanced research projects through 
ARPA–H, may enter into grants, contracts, coopera-
tive agreements, cash prizes, and other transactions 
(as defined in section 319L(a) of the Public Health 
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Service Act (42 U.S.C. 247d–7e(a))) with any per-
son, any agency or instrumentality of the United 
States, any unit of State or local government, and 
any other entity institutions, including universities, 
national laboratories, public sector organizations, 
private companies, nonprofit organizations, and for-
eign institutions. 
(2) TERMS.— 
(A) REQUIRED PROVISIONS.—The Director 
of ARPA–H shall ensure that, in entering into 
cooperative agreements and other transactions 
under paragraph (1)— 
(i) to the extent the Director of 
ARPA–H determines practicable, the Fed-
eral funds provided under the cooperative 
agreement or other transaction do not ex-
ceed the total amount provided by other 
parties to the cooperative agreement or 
other transaction; and 
(ii) the authority under paragraph (1) 
is used only when the use of standard con-
tracts or grants is not feasible or appro-
priate. 
(B) OPTIONAL
PROVISION.—Cooperative 
agreements and other transactions entered into 
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by the Director of ARPA–H under paragraph 
(1) may include a clause that requires a person 
or other entity to make payments to ARPA–H 
(or any other department or agency of the Fed-
eral Government) as a condition for receiving 
support under the agreement or other trans-
action. 
(3) DUPLICATIVE RESEARCH.—The Director of 
ARPA–H shall ensure that to the maximum extent 
practicable, a cooperative agreement or other trans-
action under this section does not provide for re-
search that duplicates research being conducted 
under existing programs carried out by the Depart-
ment of Health and Human Services, the Depart-
ment of Defense, or other Federal Government enti-
ties. 
(4) AMOUNT OF PAYMENTS.—The amount of 
any payment received by the Federal Government 
pursuant to a requirement imposed under paragraph 
(1) may be credited, to the extent authorized by the 
Director of ARPA–H, to the account established 
under paragraph (7). Amounts so credited shall be 
merged with other funds in the account and shall be 
available for the same purposes and the same period 
for which other funds in such account are available. 
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(5) MULTI-YEAR CONTRACTS.— 
(A) 
IN
GENERAL.—The 
Director 
of 
ARPA–H may enter into a multi-year contract 
if— 
(i) funds are available and obligated 
for the contract for the full period of the 
contract, or for the first fiscal year in 
which the contract is in effect, and for the 
estimated costs associated with a necessary 
termination of the contract; 
(ii) the Director determines that a 
multiyear contract will serve the best inter-
ests of the Federal Government in carrying 
out this section; and 
(iii) the contract includes a provision 
that the contract shall be terminated if 
funds are not made available for the con-
tinuation of the contract in a fiscal year 
covered by the contract. 
(B) TERMINATION COSTS.—A provision re-
ferred to in subparagraph (A)(iii) shall provide 
that funds available for paying termination 
costs shall remain available for that purpose 
until the costs associated with termination of 
the contract are paid. 
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(6) APPLICATION OF OTHER PROVISIONS.—The 
authority provided under paragraph (1) may be ex-
ercised without regard to section 3324 of title 31, 
United States Code. 
(7) ACCOUNT.—There is hereby established on 
the books of the Treasury an account for support of 
advanced research projects provided for in coopera-
tive agreements and other transactions entered into 
under paragraph (1). Funds in such account shall be 
available for the payment of such support. 
(8) PRIZE
COMPETITIONS.—The Director of 
ARPA–H may carry out prize competitions in ac-
cordance with section 24 of the Stevenson-Wydler 
Technology Innovation Act of 1980 (15 U.S.C. 
3719)) in support of the goals specified in sub-
section (b). 
(9) NONAPPLICABILITY
OF
CERTAIN
PROVI-
SIONS.—Research funded pursuant to this section 
shall not be subject to— 
(A) advisory council approval under section 
405(b)(2) of the Public Health Service Act (42 
U.S.C. 284(b)(2)); 
(B) advisory council review under section 
406(a)(3)(A)(ii) of such Act (42 U.S.C. 
284a(a)(3)(A)(ii)); or 
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(C) the peer review requirements under 
section 492 of such Act (42 U.S.C. 284(b)(2), 
289a). 
(j) CONFIDENTIALITY.— 
(1) IN GENERAL.—The information specified in 
paragraph (2) shall be exempt from disclosure under 
section 552 of title 5, United States Code (com-
monly referred to as the Freedom of Information 
Act). 
(2) INFORMATION.—The information specified 
in this paragraph is information collected by ARPA– 
H from recipients of financial assistance awards, in-
cluding the following: 
(A) Plans for commercialization of tech-
nologies developed under the award, including 
business plans, technology-to-market plans, 
market studies, and cost and performance mod-
els. 
(B) Investments provided to an awardee 
from third parties (such as venture capital 
firms, hedge funds, and private equity firms), 
including the amounts and the percentage of 
ownership of the awardee provided in return for 
the investments. 
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(k) EXPEDITING BREAKTHROUGHS THROUGH CO-
OPERATION WITH FOOD AND DRUG ADMINISTRATION.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs and in consultation with the Di-
rector of ARPA–H, may take actions to facilitate 
transformation of biomedical breakthroughs into 
tangible solutions for patients and to expedite devel-
opment of medical products, including through any 
of the following means: 
(A) Helping to ensure that medical prod-
uct development programs, in as efficient a 
manner as possible, gather the nonclinical and 
clinical data necessary to advancing the devel-
opment of such products and to obtaining their 
approval, licensure, or clearance, as applicable, 
by the Food and Drug Administration under 
sections 505, 510(k), and 515 of such Act (21 
U.S.C. 355, 360(k), 360) and section 351 of 
the Public Health Service Act (42 U.S.C. 262). 
(B) Expediting review of investigational 
new drug applications under section 505(i) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i)), review of investigational device 
exemptions under section 520(g) of such Act 
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(21 U.S.C. 360j(g)), and review of applications 
for approval, licensure, and clearance of medical 
products under sections 505, 510(k), and 515 
of such Act (21 U.S.C. 355, 360(k), 360) and 
section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
(C) Meeting at appropriate intervals with 
the Director of ARPA–H and any other appro-
priate medical product development partners, 
such as the Director of the Biomedical Ad-
vanced Research and Development Authority to 
discuss the development status of medical prod-
ucts and projects that are the highest priorities 
to ARPA–H, unless the Director of ARPA–H 
and the Commissioner of Food and Drugs de-
termine that any such meetings are not nec-
essary. 
(2) RELATION TO OTHERWISE AUTHORIZED AC-
TIVITIES OF THE FDA.—The authority specified in 
paragraph (1) shall not be construed as limiting the 
authority of the Secretary of Health and Human 
Services, acting through the Commissioner of Food 
and Drugs with respect to the review and approval, 
clearance, authorization for emergency use, or licen-
sure of a medical product under the Federal Food, 
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Drug and Cosmetic Act (21 U.S.C. 321 et seq.) or 
section 351 of the Public Health Service Act (42 
U.S.C. 262). 
(3) REIMBURSEMENT.—Utilizing interagency 
agreements or other appropriate resource allocation 
mechanisms available, the Director of ARPA–H, 
using funds made available to ARPA–H, shall reim-
burse the Food and Drug Administration for ex-
penditures made by the Food and Drug Administra-
tion for activities carried out under this section that 
have been identified by the Commissioner of Food 
and Drugs and the Director of ARPA–H as being 
carried out by the Food and Drug Administration. 
(4) MEDICAL PRODUCT DEFINED.—In this sec-
tion, the term ‘‘medical product’’ means a drug (as 
defined in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321)), a device (as de-
fined in such section 201), or a biological product 
(as defined in section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262)). 
(l) AUTHORIZATION OF APPROPRIATIONS AND BY-
PASS BUDGET AUTHORITY.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
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