Ending the Diagnostic Odyssey Act of 2019

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 chil- dren under the Medicaid program, and for other pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Ending the Diagnostic 4 Odyssey Act of 2019’’. 5 VerDate Sep 11 2014 23:31 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144 kjohnson on DSK79L0C42 with BILLS 2 •HR 4144 IH SEC. 2. STATE OPTION TO PROVIDE WHOLE GENOME SE- 1 QUENCING CLINICAL SERVICES FOR CER- 2 TAIN CHILDREN. 3 Title XIX of the Social Security Act (42 U.S.C. 1396 4 et seq.) is amended by inserting after section 1943 the 5 following new section: 6 ‘‘SEC. 1944. STATE OPTION TO PROVIDE WHOLE GENOME 7 SEQUENCING CLINICAL SERVICES FOR CER- 8 TAIN CHILDREN. 9 ‘‘(a) IN GENERAL.—Notwithstanding section 10 1902(a)(1) (relating to statewideness), section 11 1902(a)(10)(B) (relating to comparability), and any other 12 provision of this title for which the Secretary determines 13 it is necessary to waive in order to implement this section, 14 beginning January 1, 2020, a State, at its option as a 15 State plan amendment, may provide for medical assistance 16 under this title to an eligible individual for purposes of 17 providing the individual with whole genome sequencing 18 clinical services. 19 ‘‘(b) PAYMENTS.— 20 ‘‘(1) IN GENERAL.—A State shall provide a 21 health care provider (as defined by the State) with 22 payments for the provision of whole genome sequenc- 23 ing clinical services to any eligible individual. Pay- 24 ments made to a health care provider for such serv- 25 ices shall be treated as medical assistance for pur- 26 VerDate Sep 11 2014 21:00 Aug 19, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144 kjohnson on DSK79L0C42 with BILLS 3 •HR 4144 IH poses of section 1903(a), except that, during the 1 first 12 fiscal year quarters that the State plan 2 amendment is in effect, the Federal medical assist- 3 ance percentage applicable to such payments shall be 4 equal to 75 percent. 5 ‘‘(2) METHODOLOGY.—The State shall specify 6 in the State plan amendment the methodology the 7 State will use for determining payment for the provi- 8 sion of whole genome sequencing clinical services. 9 Such methodology for determining payment shall be 10 established consistent with section 1902(a)(30)(A). 11 ‘‘(3) PLANNING GRANTS.— 12 ‘‘(A) IN GENERAL.—Beginning January 1, 13 2020, the Secretary may award planning grants 14 to States for purposes of developing a State 15 plan amendment under this section. A planning 16 grant awarded to a State under this paragraph 17 shall remain available until expended. 18 ‘‘(B) STATE CONTRIBUTION.—A State 19 awarded a planning grant shall contribute an 20 amount equal to the State percentage deter- 21 mined under section 1905(b) for each fiscal 22 year for which the grant is awarded. 23 ‘‘(c) HOSPITAL REFERRALS.—A State shall include 24 in the State plan amendment a requirement for any hos- 25 VerDate Sep 11 2014 23:31 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144 kjohnson on DSK79L0C42 with BILLS 4 •HR 4144 IH pital that is a participating provider under the State plan 1 (or a waiver of such plan) to establish procedures for re- 2 ferring any eligible individual who seeks or needs treat- 3 ment in a hospital emergency department to a health care 4 provider who is qualified (as determined by the State) to 5 provide whole genome sequencing clinical services. 6 ‘‘(d) REPORTS BY STATES.—Not later than 3 years 7 after the date on which the State plan amendment under 8 this section is approved, a State shall submit a report to 9 the Administrator of the Centers for Medicare & Medicaid 10 Services and the Administrator of the Health Resources 11 and Services Administration on— 12 ‘‘(1) the extent to which whole genomic se- 13 quencing clinical services reduce health disparities; 14 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.—As a 21 condition for receiving payment for whole genome sequenc- 22 ing clinical services provided to an eligible individual, a 23 health care provider shall report to the State, in accord- 24 ance with such requirements as the Secretary shall specify, 25 VerDate Sep 11 2014 23:31 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144 kjohnson on DSK79L0C42 with BILLS 5 •HR 4144 IH on all applicable measures for determining the quality of 1 such services. 2 ‘‘(f) DEFINITIONS.—In this section: 3 ‘‘(1) ELIGIBLE INDIVIDUAL.—The term ‘eligible 4 individual’ means an individual— 5 ‘‘(A) who is eligible for medical assistance 6 under the State plan (or a waiver of such plan); 7 ‘‘(B) who is under the age of 21 (or, at the 8 option of the State, under the age of 20, 19, or 9 18 as the State may choose), or in the case of 10 an individual described in section 11 1902(a)(10)(A)(i)(IX), under the age of 26; 12 and 13 ‘‘(C) who— 14 ‘‘(i) has been referred or admitted to 15 an intensive care unit, or has been seen by 16 at least one medical specialist, for a sus- 17 pected genetic or undiagnosed disease; or 18 ‘‘(ii) is suspected by at least one med- 19 ical specialist to have a neonatal- or pedi- 20 atric-onset genetic disease. 21 ‘‘(2) WHOLE GENOME SEQUENCING CLINICAL 22 SERVICES.—The term ‘whole genome sequencing 23 clinical services’, with respect to an eligible indi- 24 vidual— 25 VerDate Sep 11 2014 23:31 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4144.IH H4144 kjohnson on DSK79L0C42 with BILLS 6 •HR 4144 IH ‘‘(A) means the unbiased sequencing of all 1 deoxyribonucleic acid bases in the genome of 2 such individual and, if for the sole benefit of 3 the individual, a biological parent of such indi- 4 vidual for the purpose of determining whether 5 one or more potentially disease-causing genetic 6 variants are present in the genome of such indi- 7 vidual or such biological parent; and 8 ‘‘(B) includes any analysis, interpretation, 9 and data report derived from such sequenc- 10 ing.’’. 11 Æ VerDate Sep 11 2014 23:31 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H4144.IH H4144 kjohnson on DSK79L0C42 with BILLS