I 
116TH CONGRESS 
1ST SESSION H. R. 4393 
To amend title XIX of the Social Security Act to provide for a State option 
under the State Medicaid plan to provide DNA sequencing clinical serv-
ices for certain children, provide for a study by the National Academy 
of Medicine on the use of genetic and genomic testing to improve health 
care, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 18, 2019 
Mr. SWALWELL of California (for himself, Mr. FITZPATRICK, Mr. GALLEGO, 
Mr. ROUDA, and Ms. NORTON) introduced the following bill; which was 
referred to the Committee on Energy and Commerce 
A BILL 
To amend title XIX of the Social Security Act to provide 
for a State option under the State Medicaid plan to 
provide DNA sequencing clinical services for certain chil-
dren, provide for a study by the National Academy of 
Medicine on the use of genetic and genomic testing to 
improve health care, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Advancing Access to 
Precision Medicine Act’’. 
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SEC. 2. STATE OPTION TO PROVIDE DNA SEQUENCING 
CLINICAL SERVICES FOR CERTAIN CHIL-
DREN. 
Title XIX of the Social Security Act (42 U.S.C. 1396 
et seq.) is amended by adding at the end the following 
new section: 
‘‘SEC. 1947. STATE OPTION TO PROVIDE DNA SEQUENCING 
CLINICAL SERVICES FOR CERTAIN CHIL-
DREN. 
‘‘(a) 
IN
GENERAL.—Notwithstanding 
section 
1902(a)(1) 
(relating 
to 
statewideness), 
section 
1902(a)(10)(B) (relating to comparability), and any other 
provision of this title for which the Secretary determines 
it is necessary to waive in order to implement this section, 
beginning on the first day of the first fiscal quarter that 
begins on or after the date of the enactment of this sec-
tion, a State, at its option as a State plan amendment, 
may provide for medical assistance under this title to an 
eligible individual for purposes of providing the individual 
with DNA sequencing clinical services. 
‘‘(b) PAYMENTS.— 
‘‘(1) IN
GENERAL.—A State shall provide a 
health care provider (as defined by the State) with 
payments for the provision of DNA sequencing clin-
ical services to any eligible individual. Payments 
made to a health care provider for such services 
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shall be treated as medical assistance for purposes 
of section 1903(a), except that, during the first 8 
fiscal year quarters that the State plan amendment 
is in effect, the Federal medical assistance percent-
age applicable to such payments shall be equal to 75 
percent. 
‘‘(2) METHODOLOGY.—The State shall specify 
in the State plan amendment the methodology the 
State will use for determining payment for the provi-
sion of DNA sequencing clinical services. Such meth-
odology for determining payment shall be established 
consistent with section 1902(a)(30)(A). 
‘‘(3) PLANNING GRANTS.— 
‘‘(A) IN GENERAL.—Beginning on the date 
described in subsection (a), the Secretary may 
award planning grants to States for purposes of 
developing a State plan amendment under this 
section. A planning grant awarded to a State 
under this paragraph shall remain available 
until expended. 
‘‘(B) STATE
CONTRIBUTION.—A State 
awarded a planning grant shall contribute an 
amount equal to the State percentage deter-
mined under section 1905(b) for each fiscal 
year for which the grant is awarded. 
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‘‘(c) HOSPITAL REFERRALS.—A State shall include 
in the State plan amendment a requirement for any hos-
pital that is a participating provider under the State plan 
(or a waiver of such plan) to establish procedures for re-
ferring any eligible 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 DNA sequencing clinical services. 
‘‘(d) REPORTS BY STATES.—Not later than three 
years after the date on which the State plan amendment 
under this section is approved, a State shall submit a re-
port to the Administrator of the Centers for Medicare & 
Medicaid Services and the Administrator of the Health 
Resources and Services Administration on— 
‘‘(1) the extent to which DNA sequencing clin-
ical services reduce health disparities; and 
‘‘(2) the extent to which coverage under the 
State plan (or a waiver of such plan) impedes the 
use of genetic and genomic testing that may improve 
clinical outcomes for eligible individuals enrolled in 
the State plan (or under a waiver of such plan). 
‘‘(e) REPORTS BY HEALTH CARE PROVIDERS.—As a 
condition for receiving payment for DNA sequencing clin-
ical services provided to an eligible individual, a health 
care provider shall report to the State, in accordance with 
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such requirements as the Secretary shall specify, on all 
applicable measures for determining the quality of such 
services. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) ELIGIBLE INDIVIDUAL.—The term ‘eligible 
individual’ means an individual who— 
‘‘(A) is eligible for medical assistance 
under the State plan (or a waiver of such plan); 
‘‘(B) is under the age of 21 (or, at the op-
tion 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 
section 
1902(a)(10)(A)(i)(IX), under the age of 26; 
‘‘(C) has been referred or admitted to a 
pediatric intensive care unit for a chronic or 
undiagnosed disease; 
‘‘(D) has been seen by at least one medical 
specialist for such chronic or undiagnosed dis-
ease; and 
‘‘(E) is suspected by at least one medical 
specialist to have a pediatric-onset genetic dis-
ease. 
‘‘(2) DNA SEQUENCING CLINICAL SERVICES.— 
The term ‘DNA sequencing clinical services’, with 
respect to an eligible individual— 
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‘‘(A) means a determination of an exact 
sequence of deoxyribonucleic acid bases in the 
genome of such individual, and, if for the sole 
benefit of the individual, a biological parent of 
such individual for the purpose of determining 
whether one or more potentially disease-causing 
genetic variants are present in the genome of 
such individual or such biological parent; and 
‘‘(B) includes— 
‘‘(i) sequencing of the entire genome, 
of the exome, of a panel of genes, or other 
regions of the genome; and 
‘‘(ii) any analysis, interpretation, and 
data report derived from such sequenc-
ing.’’. 
SEC. 3. NATIONAL ACADEMY OF MEDICINE STUDY. 
(a) IN GENERAL.—Not later than 4 years after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall enter into an arrangement with 
the National Academy of Medicine under which the Acad-
emy agrees to study— 
(1) how genetic and genomic testing may im-
prove preventative care and precision medicine; 
(2) how genetic and genomic testing may re-
duce health disparities; 
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(3) how the Federal Government may help to 
reduce barriers to genetic and genomic testing, in-
cluding— 
(A) encouraging the expansion of health 
insurance coverage of genetic and genomic test-
ing, including diagnostic, predictive, and pre-
symptomatic testing, and DNA sequencing clin-
ical services (as defined in section 1947 of the 
Social Security Act (as added by section 2)); 
(B) supporting the collection of evidence 
for the clinical utility and appropriate use of ge-
netic and genomic tests; and 
(C) improving access to genetic counselors, 
pathologists, and other relevant professions, in-
cluding strengthening related workforce edu-
cation and training efforts; 
(4)(A) the extent to which coverage provisions 
in the Medicare and Medicaid programs under titles 
XVIII and XIX of the Social Security 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; 
(B) the extent to which coverage provided pur-
suant to section 1947 of the Social Security Act (as 
added by section 2) increased the use of genetic and 
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genomic testing and improved clinical outcomes for 
beneficiaries; and 
(C) how the Centers for Medicare & Medicaid 
Services may make coverage determinations that 
better suit a precision medicine approach to treat-
ment; and 
(5) how genetic and genomic testing may im-
prove health outcomes for all populations in the 
United States, including— 
(A) individuals with a rare disease, includ-
ing— 
(i) a metabolic disease; 
(ii) a hereditary cancer syndrome; and 
(iii) a neurologic disease with known 
treatments; and 
(B) special populations, including— 
(i) infants and children; 
(ii) critically ill (non-infectious and 
non-trauma) patients; 
(iii) transplant patients; 
(iv) individuals with cardiac disease; 
and 
(v) individuals with, or who have a 
family history of, a birth defect or develop-
mental disability. 
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(b) REPORT.— 
(1) IN GENERAL.—The arrangement under sub-
section (a) shall provide for the National Academy 
of Medicine to submit, not later than 6 years after 
the date of enactment of this Act, a report on the 
results of the study under subsection (a) to— 
(A) the Secretary of Health and Human 
Services; 
(B) the Committee on Ways and Means 
and the Committee on Energy and Commerce 
of the House of Representatives; and 
(C) the Committee on Finance and the 
Committee on Health, Education, Labor, and 
Pensions of the Senate. 
(2) CONSULTATION.—The arrangement under 
subsection (a) shall provide for the National Acad-
emy of Medicine, in developing the report required 
by paragraph (1), to consult with physicians, other 
health professionals, health educators, health profes-
sional organizations, relevant companies, patients, 
patient organizations, the Health Resources and 
Services Administration, the National Cancer Insti-
tute, the National Institutes of Health, the Agency 
for Healthcare Research and Quality, and the Cen-
ters for Medicare & Medicaid Services. 
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(3) USE
OF
INFORMATION.—The National 
Academy of Medicine shall, to the extent possible, in 
conducting the study under subsection (a), utilize in-
formation included in the reports submitted pursu-
ant to subsections (d) and (e) of section 1947 of the 
Social Security Act (as added by section 2). 
Æ 
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