Bill Summary
This legislation, 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 for whole genome sequencing to eligible individuals, defined as those under the age of 21 (or up to age 26 for certain individuals) who have been referred to a specialist for a suspected genetic disease. The state can determine the payment methodology for these services, with a federal medical assistance percentage of 75% during the first 12 fiscal quarters. The legislation also requires hospitals to refer eligible individuals to qualified providers for whole genome sequencing, and requires states to report on the impact of these services on health disparities and the use of genetic testing. Health care providers must report on the quality of the services they provide. The legislation defines whole genome sequencing as the sequencing of an individual's entire DNA and includes any analysis and interpretation of the data.
Possible Impacts
1. Under this legislation, states have the option to provide whole genome sequencing clinical services for certain children under Medicaid. This could affect families with undiagnosed children who may have previously been unable to afford these services, as they may now have access to potentially life-saving diagnostic tools.
2. The legislation also requires hospitals to refer eligible individuals to qualified healthcare providers for whole genome sequencing clinical services. This could affect hospitals and healthcare providers by increasing their workload and potentially requiring them to invest in additional training and resources to provide these services.
3. The reports required by states and healthcare providers could also affect individuals by potentially impacting their privacy and confidentiality, as sensitive genetic and genomic information would need to be shared in order to comply with reporting requirements. This could also affect the individual's willingness to seek out these services if they are concerned about the potential consequences of their genetic information being shared.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3116 Introduced in Senate (IS)]
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116th CONGRESS
1st Session
S. 3116
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 SENATE OF THE UNITED STATES
December 19, 2019
Ms. Collins (for herself, Mr. Jones, Ms. McSally, and Mr. Menendez)
introduced the following bill; which was read twice and referred to the
Committee on Finance
_______________________________________________________________________
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 1946 the following new section:
``SEC. 1947. 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 which the Secretary determines 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 a State plan amendment under this section is approved, 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--
``(1) the extent to which whole genome 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.--Each State that provides
medical assistance for whole genome sequencing clinical services under
this section shall require that, 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 1 medical specialist, for a suspected
genetic or undiagnosed disease; or
``(ii) is suspected by at least 1 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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