Advancing Access to Precision Medicine Act
This bill requires the Department of Health and Human Services to enter into an arrangement with the National Academy of Medicine for the academy to study usage of genetic and genomic testing, including how to reduce barriers to the utilization of such testing.
The bill allows states to apply for an exception to Medicaid's federal medical assistance percentage rate to provide whole genome sequencing clinical services to certain children, including those admitted to a pediatric intensive care unit for a chronic or undiagnosed disease and those suspected to have a pediatric-onset genetic disease.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5062 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 5062
To 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
February 15, 2018
Mr. Swalwell of California (for himself, Mr. Shimkus, Mr. Peters, Mr.
Paulsen, and Mr. Vargas) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To 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. NATIONAL ACADEMY OF MEDICINE STUDY.
(a) In General.--Not later than 60 days 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
whole genome sequencing;
(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; and
(B) 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 3 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.
SEC. 3. STATE OPTION TO PROVIDE WHOLE GENOME SEQUENCING CLINICAL
SERVICES FOR CERTAIN CHILDREN.
Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is
amended by inserting after section 1943 the following new section:
``SEC. 1944. STATE OPTION TO PROVIDE WHOLE GENOME 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
January 1, 2019, 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 whole genome
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 whole genome 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 whole genome
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 January 1, 2019, 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 whole genome
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 whole genomic 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 whole genome 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) Whole genome sequencing clinical services.--The term
`whole genome sequencing clinical services', with respect to an
eligible individual--
``(A) means the unbiased sequencing of all
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 any analysis, interpretation, and
data report derived from such sequencing.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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