II 

117TH CONGRESS 

1ST SESSION S. 2022 

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 

JUNE 10, 2021 

Ms. COLLINS (for herself, Mr. KELLY, 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. 

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 2021’’. 


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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 1947 the 

6 following new section: 

7 ‘‘SEC. 1948. 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 which the Secretary determines is 

14 necessary to waive in order to implement this section, be15 ginning January 1, 2022, a State, at its option as a State 

16 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 07:01 Jun 23, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2022.IS S2022

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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 2022, 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 07:01 Jun 23, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2022.IS S2022

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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 a State plan amendment under 

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

10 to the Administrator of the Centers for Medicare & Med11 icaid Services and the Administrator of the Health Re12 sources and Services Administration on— 

13 ‘‘(1) the extent to which whole genome sequenc14 ing clinical services reduce health disparities; and 

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

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

17 use of genetic and genomic testing that may improve 

18 clinical outcomes for eligible individuals enrolled in 

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

20 ‘‘(e) REPORTS BY HEALTH CARE PROVIDERS.—Each 

21 State that provides medical assistance for whole genome 

22 sequencing clinical services under this section shall require 

23 that, as a condition for receiving payment for whole ge24 nome sequencing clinical services provided to an eligible 

25 individual, a health care provider shall report to the State, 


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1 in accordance with such requirements as the Secretary 

2 shall specify, on all applicable measures for determining 

3 the quality of such services. 

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

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

6 individual’ means an individual— 

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

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

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

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

11 18 as the State may choose), or in the case of 

12 an individual described in section 

13 1902(a)(10)(A)(i)(IX), under the age of 26; 

14 and 

15 ‘‘(C) who— 

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

17 an intensive care unit, or has been seen by 

18 at least 1 medical specialist, for a sus19 pected genetic or undiagnosed disease; or 

20 ‘‘(ii) is suspected by at least 1 medical 

21 specialist to have a neonatal- or pediatric22 onset genetic disease. 

23 ‘‘(2) WHOLE GENOME SEQUENCING CLINICAL

24 SERVICES.—The term ‘whole genome sequencing 


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1 clinical services’, with respect to an eligible indi2 vidual— 

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

4 deoxyribonucleic acid bases in the genome of 

5 such individual and, if for the sole benefit of 

6 the individual, a biological parent of such indi7 vidual for the purpose of determining whether 

8 one or more potentially disease-causing genetic 

9 variants are present in the genome of such indi10 vidual or such biological parent; and 

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

12 and data report derived from such sequenc13 ing.’’. 

Æ 


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