[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4393 Introduced in House (IH)]
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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
services 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 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.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. STATE OPTION TO PROVIDE DNA SEQUENCING CLINICAL SERVICES FOR
CERTAIN CHILDREN.
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 CHILDREN.
``(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 section, 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 clinical services to any eligible
individual. Payments made to a health care provider for such
services 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 percentage 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 provision of DNA sequencing
clinical services. Such methodology 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 determined under section 1905(b) for
each fiscal year for which the grant is awarded.
``(c) Hospital Referrals.--A State shall include in the State plan
amendment a requirement for any hospital that is a participating
provider under the State plan (or a waiver of such plan) to establish
procedures for referring any eligible individual who seeks or needs
treatment 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 report 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 clinical 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 clinical services provided to an
eligible individual, a health care provider shall report to the State,
in accordance with 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 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 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 disease; and
``(E) is suspected by at least one medical
specialist to have a pediatric-onset genetic disease.
``(2) DNA sequencing clinical services.--The term `DNA
sequencing clinical services', with respect to an eligible
individual--
``(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 sequencing.''.
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 Academy agrees to study--
(1) how genetic and genomic testing may improve
preventative care and precision medicine;
(2) how genetic and genomic testing may reduce health
disparities;
(3) how the Federal Government may help to reduce barriers
to genetic and genomic testing, including--
(A) encouraging the expansion of health insurance
coverage of genetic and genomic testing, including
diagnostic, predictive, and presymptomatic testing, and
DNA sequencing clinical 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 genetic and
genomic tests; and
(C) improving access to genetic counselors,
pathologists, and other relevant professions, including
strengthening related workforce education 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 pursuant to
section 1947 of the Social Security Act (as added by section 2)
increased the use of genetic and 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 treatment; and
(5) how genetic and genomic testing may improve health
outcomes for all populations in the United States, including--
(A) individuals with a rare disease, including--
(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 developmental
disability.
(b) Report.--
(1) In general.--The arrangement under subsection (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 Academy of Medicine, in
developing the report required by paragraph (1), to consult
with physicians, other health professionals, health educators,
health professional organizations, relevant companies,
patients, patient organizations, 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.
(3) Use of information.--The National Academy of Medicine
shall, to the extent possible, in conducting the study under
subsection (a), utilize information included in the reports
submitted pursuant to subsections (d) and (e) of section 1947
of the Social Security Act (as added by section 2).
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