Bill Summary
This bill, called the "Ending the Diagnostic Odyssey Act of 2019," aims to improve access to whole genome sequencing clinical services for certain undiagnosed children under the Medicaid program. It allows states to provide medical assistance under Medicaid for whole genome sequencing services, which involves sequencing an individual's entire genome to identify any potential disease-causing genetic variants. The bill also includes provisions for payment to healthcare providers, planning grants for states, hospital referrals, and reporting requirements for states and healthcare providers. It defines eligible individuals as those under the age of 21 (or at the state's option, under the age of 20, 19, or 18) who have been referred to an intensive care unit or medical specialist for a suspected genetic or undiagnosed disease. The bill also specifies that whole genome sequencing services include analysis, interpretation, and data reporting.
Possible Impacts
1. Families with children with undiagnosed diseases may have easier access to whole genome sequencing clinical services, leading to earlier diagnosis and potential treatment options.
2. States may have to allocate more funds to cover the costs of providing whole genome sequencing clinical services to eligible individuals under the Medicaid program.
3. Health care providers may be required to report on the quality of their services in order to receive payment for whole genome sequencing clinical services, potentially affecting their workload and reimbursement rates.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4144 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 4144
To enable States to better provide access to whole genome sequencing
clinical services for certain undiagnosed children under the Medicaid
program, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 2, 2019
Mr. Peters (for himself, Mr. Shimkus, and Mr. Vargas) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To enable States to better provide access to whole genome sequencing
clinical services for certain undiagnosed children under the Medicaid
program, 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 ``Ending the Diagnostic Odyssey Act of
2019''.
SEC. 2. 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, 2020, 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 12
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, 2020, 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 3 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--
``(A) who is eligible for medical assistance under
the State plan (or a waiver of such plan);
``(B) who 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; and
``(C) who--
``(i) has been referred or admitted to an
intensive care unit, or has been seen by at
least one medical specialist, for a suspected
genetic or undiagnosed disease; or
``(ii) is suspected by at least one medical
specialist to have a neonatal- or 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.''.
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