I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ending the Diagnostic 

5 Odyssey Act of 2019’’. 


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1 SEC. 2. STATE OPTION TO PROVIDE WHOLE GENOME SE2 QUENCING CLINICAL SERVICES FOR CER3 TAIN CHILDREN. 

4 Title XIX of the Social Security Act (42 U.S.C. 1396 

5 et seq.) is amended by inserting after section 1943 the 

6 following new section: 

7 ‘‘SEC. 1944. STATE OPTION TO PROVIDE WHOLE GENOME 

8 SEQUENCING CLINICAL SERVICES FOR CER9 TAIN CHILDREN. 

10 ‘‘(a) IN GENERAL.—Notwithstanding section 

11 1902(a)(1) (relating to statewideness), section 

12 1902(a)(10)(B) (relating to comparability), and any other 

13 provision of this title for which the Secretary determines 

14 it is necessary to waive in order to implement this section, 

15 beginning January 1, 2020, a State, at its option as a 

16 State plan amendment, may provide for medical assistance 

17 under this title to an eligible individual for purposes of 

18 providing the individual with whole genome sequencing 

19 clinical services. 

20 ‘‘(b) PAYMENTS.— 

21 ‘‘(1) IN GENERAL.—A State shall provide a 

22 health care provider (as defined by the State) with 

23 payments for the provision of whole genome sequenc24 ing clinical services to any eligible individual. Pay25 ments made to a health care provider for such serv26 ices shall be treated as medical assistance for purVerDate Sep 11 2014 21:00 Aug 19, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144

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1 poses of section 1903(a), except that, during the 

2 first 12 fiscal year quarters that the State plan 

3 amendment is in effect, the Federal medical assist4 ance percentage applicable to such payments shall be 

5 equal to 75 percent. 

6 ‘‘(2) METHODOLOGY.—The State shall specify 

7 in the State plan amendment the methodology the 

8 State will use for determining payment for the provi9 sion of whole genome sequencing clinical services. 

10 Such methodology for determining payment shall be 

11 established consistent with section 1902(a)(30)(A). 

12 ‘‘(3) PLANNING GRANTS.— 

13 ‘‘(A) IN GENERAL.—Beginning January 1, 

14 2020, the Secretary may award planning grants 

15 to States for purposes of developing a State 

16 plan amendment under this section. A planning 

17 grant awarded to a State under this paragraph 

18 shall remain available until expended. 

19 ‘‘(B) STATE CONTRIBUTION.—A State 

20 awarded a planning grant shall contribute an 

21 amount equal to the State percentage deter22 mined under section 1905(b) for each fiscal 

23 year for which the grant is awarded. 

24 ‘‘(c) HOSPITAL REFERRALS.—A State shall include 

25 in the State plan amendment a requirement for any hosVerDate Sep 11 2014 23:31 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144

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1 pital that is a participating provider under the State plan 

2 (or a waiver of such plan) to establish procedures for re3 ferring any eligible individual who seeks or needs treat4 ment in a hospital emergency department to a health care 

5 provider who is qualified (as determined by the State) to 

6 provide whole genome sequencing clinical services. 

7 ‘‘(d) REPORTS BY STATES.—Not later than 3 years 

8 after the date on which the State plan amendment under 

9 this section is approved, a State shall submit a report to 

10 the Administrator of the Centers for Medicare & Medicaid 

11 Services and the Administrator of the Health Resources 

12 and Services Administration on— 

13 ‘‘(1) the extent to which whole genomic se14 quencing clinical services reduce health disparities; 

15 and 

16 ‘‘(2) the extent to which coverage under the 

17 State plan (or a waiver of such plan) impedes the 

18 use of genetic and genomic testing that may improve 

19 clinical outcomes for eligible individuals enrolled in 

20 the State plan (or under a waiver of such plan). 

21 ‘‘(e) REPORTS BY HEALTH CARE PROVIDERS.—As a 

22 condition for receiving payment for whole genome sequenc23 ing clinical services provided to an eligible individual, a 

24 health care provider shall report to the State, in accord25 ance with such requirements as the Secretary shall specify, 


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1 on all applicable measures for determining the quality of 

2 such services. 

3 ‘‘(f) DEFINITIONS.—In this section: 

4 ‘‘(1) ELIGIBLE INDIVIDUAL.—The term ‘eligible 

5 individual’ means an individual— 

6 ‘‘(A) who is eligible for medical assistance 

7 under the State plan (or a waiver of such plan); 

8 ‘‘(B) who is under the age of 21 (or, at the 

9 option of the State, under the age of 20, 19, or 

10 18 as the State may choose), or in the case of 

11 an individual described in section 

12 1902(a)(10)(A)(i)(IX), under the age of 26; 

13 and 

14 ‘‘(C) who— 

15 ‘‘(i) has been referred or admitted to 

16 an intensive care unit, or has been seen by 

17 at least one medical specialist, for a sus18 pected genetic or undiagnosed disease; or 

19 ‘‘(ii) is suspected by at least one med20 ical specialist to have a neonatal- or pedi21 atric-onset genetic disease. 

22 ‘‘(2) WHOLE GENOME SEQUENCING CLINICAL

23 SERVICES.—The term ‘whole genome sequencing 

24 clinical services’, with respect to an eligible indi25 vidual— 


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1 ‘‘(A) means the unbiased sequencing of all 

2 deoxyribonucleic acid bases in the genome of 

3 such individual and, if for the sole benefit of 

4 the individual, a biological parent of such indi5 vidual for the purpose of determining whether 

6 one or more potentially disease-causing genetic 

7 variants are present in the genome of such indi8 vidual or such biological parent; and 

9 ‘‘(B) includes any analysis, interpretation, 

10 and data report derived from such sequenc11 ing.’’. 

Æ 


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