Title: Ending the Diagnostic Odyssey Act of 2019
Policy area: Health

Summary:
Ending the Diagnostic Odyssey Act of 2019
This bill allows state Medicaid programs to cover whole genome sequencing services for certain individuals.
Specifically, states may cover such services for individuals under the age of 21 (or a lower age, if the state chooses) and for former foster youth under the age of 26 who (1) have been referred or admitted to an intensive care unit or seen by a medical specialist for a suspected genetic or undiagnosed disease, or (2) are suspected by a medical specialist to have a neonatal- or pediatric-onset genetic disease.
The Centers for Medicare & Medicaid Services may award grants to assist states in developing plans to cover such services.

[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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