Advancing Access to Precision Medicine Act

I 116TH CONGRESS 1ST SESSION H. R. 4393 To amend title XIX of the Social Security Act to provide for a State option under the State Medicaid plan to provide DNA sequencing clinical serv- ices for certain children, provide for a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care, and for other purposes. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 18, 2019 Mr. SWALWELL of California (for himself, Mr. FITZPATRICK, Mr. GALLEGO, Mr. ROUDA, and Ms. NORTON) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend title XIX of the Social Security Act to provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain chil- dren, provide for a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care, and for other purposes. 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 ‘‘Advancing Access to 4 Precision Medicine Act’’. 5 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 2 •HR 4393 IH SEC. 2. STATE OPTION TO PROVIDE DNA SEQUENCING 1 CLINICAL SERVICES FOR CERTAIN CHIL- 2 DREN. 3 Title XIX of the Social Security Act (42 U.S.C. 1396 4 et seq.) is amended by adding at the end the following 5 new section: 6 ‘‘SEC. 1947. STATE OPTION TO PROVIDE DNA SEQUENCING 7 CLINICAL SERVICES FOR CERTAIN CHIL- 8 DREN. 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 on the first day of the first fiscal quarter that 15 begins on or after the date of the enactment of this sec- 16 tion, a State, at its option as a State plan amendment, 17 may provide for medical assistance under this title to an 18 eligible individual for purposes of providing the individual 19 with DNA sequencing 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 DNA sequencing clin- 24 ical services to any eligible individual. Payments 25 made to a health care provider for such services 26 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 3 •HR 4393 IH shall be treated as medical assistance for purposes 1 of section 1903(a), except that, during the first 8 2 fiscal year quarters that the State plan amendment 3 is in effect, the Federal medical assistance percent- 4 age applicable to such payments shall be equal to 75 5 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 provi- 9 sion of DNA sequencing clinical services. Such meth- 10 odology for determining payment shall be established 11 consistent with section 1902(a)(30)(A). 12 ‘‘(3) PLANNING GRANTS.— 13 ‘‘(A) IN GENERAL.—Beginning on the date 14 described in subsection (a), the Secretary may 15 award planning grants to States for purposes of 16 developing a State plan amendment under this 17 section. A planning grant awarded to a State 18 under this paragraph shall remain available 19 until expended. 20 ‘‘(B) STATE CONTRIBUTION.—A State 21 awarded a planning grant shall contribute an 22 amount equal to the State percentage deter- 23 mined under section 1905(b) for each fiscal 24 year for which the grant is awarded. 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 4 •HR 4393 IH ‘‘(c) HOSPITAL REFERRALS.—A State shall include 1 in the State plan amendment a requirement for any hos- 2 pital that is a participating provider under the State plan 3 (or a waiver of such plan) to establish procedures for re- 4 ferring any eligible individual who seeks or needs treat- 5 ment in a hospital emergency department to a health care 6 provider who is qualified (as determined by the State) to 7 provide DNA sequencing clinical services. 8 ‘‘(d) REPORTS BY STATES.—Not later than three 9 years after the date on which the State plan amendment 10 under this section is approved, a State shall submit a re- 11 port to the Administrator of the Centers for Medicare & 12 Medicaid Services and the Administrator of the Health 13 Resources and Services Administration on— 14 ‘‘(1) the extent to which DNA sequencing clin- 15 ical services reduce health disparities; 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 DNA sequencing clin- 23 ical services provided to an eligible individual, a health 24 care provider shall report to the State, in accordance with 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 5 •HR 4393 IH such requirements as the Secretary shall specify, on all 1 applicable measures for determining the quality of such 2 services. 3 ‘‘(f) DEFINITIONS.—In this section: 4 ‘‘(1) ELIGIBLE INDIVIDUAL.—The term ‘eligible 5 individual’ means an individual who— 6 ‘‘(A) is eligible for medical assistance 7 under the State plan (or a waiver of such plan); 8 ‘‘(B) is under the age of 21 (or, at the op- 9 tion 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 ‘‘(C) has been referred or admitted to a 14 pediatric intensive care unit for a chronic or 15 undiagnosed disease; 16 ‘‘(D) has been seen by at least one medical 17 specialist for such chronic or undiagnosed dis- 18 ease; and 19 ‘‘(E) is suspected by at least one medical 20 specialist to have a pediatric-onset genetic dis- 21 ease. 22 ‘‘(2) DNA SEQUENCING CLINICAL SERVICES.— 23 The term ‘DNA sequencing clinical services’, with 24 respect to an eligible individual— 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 6 •HR 4393 IH ‘‘(A) means a determination of an exact 1 sequence of deoxyribonucleic acid bases in the 2 genome of such individual, and, if for the sole 3 benefit of the individual, a biological parent of 4 such individual for the purpose of determining 5 whether one or more potentially disease-causing 6 genetic variants are present in the genome of 7 such individual or such biological parent; and 8 ‘‘(B) includes— 9 ‘‘(i) sequencing of the entire genome, 10 of the exome, of a panel of genes, or other 11 regions of the genome; and 12 ‘‘(ii) any analysis, interpretation, and 13 data report derived from such sequenc- 14 ing.’’. 15 SEC. 3. NATIONAL ACADEMY OF MEDICINE STUDY. 16 (a) IN GENERAL.—Not later than 4 years after the 17 date of the enactment of this Act, the Secretary of Health 18 and Human Services shall enter into an arrangement with 19 the National Academy of Medicine under which the Acad- 20 emy agrees to study— 21 (1) how genetic and genomic testing may im- 22 prove preventative care and precision medicine; 23 (2) how genetic and genomic testing may re- 24 duce health disparities; 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 7 •HR 4393 IH (3) how the Federal Government may help to 1 reduce barriers to genetic and genomic testing, in- 2 cluding— 3 (A) encouraging the expansion of health 4 insurance coverage of genetic and genomic test- 5 ing, including diagnostic, predictive, and pre- 6 symptomatic testing, and DNA sequencing clin- 7 ical services (as defined in section 1947 of the 8 Social Security Act (as added by section 2)); 9 (B) supporting the collection of evidence 10 for the clinical utility and appropriate use of ge- 11 netic and genomic tests; and 12 (C) improving access to genetic counselors, 13 pathologists, and other relevant professions, in- 14 cluding strengthening related workforce edu- 15 cation and training efforts; 16 (4)(A) the extent to which coverage provisions 17 in the Medicare and Medicaid programs under titles 18 XVIII and XIX of the Social Security Act (42 19 U.S.C. 1395 et seq., 1396 et seq.) may restrain the 20 use of genetic and genomic testing that may improve 21 clinical outcomes for beneficiaries; 22 (B) the extent to which coverage provided pur- 23 suant to section 1947 of the Social Security Act (as 24 added by section 2) increased the use of genetic and 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 8 •HR 4393 IH genomic testing and improved clinical outcomes for 1 beneficiaries; and 2 (C) how the Centers for Medicare & Medicaid 3 Services may make coverage determinations that 4 better suit a precision medicine approach to treat- 5 ment; and 6 (5) how genetic and genomic testing may im- 7 prove health outcomes for all populations in the 8 United States, including— 9 (A) individuals with a rare disease, includ- 10 ing— 11 (i) a metabolic disease; 12 (ii) a hereditary cancer syndrome; and 13 (iii) a neurologic disease with known 14 treatments; and 15 (B) special populations, including— 16 (i) infants and children; 17 (ii) critically ill (non-infectious and 18 non-trauma) patients; 19 (iii) transplant patients; 20 (iv) individuals with cardiac disease; 21 and 22 (v) individuals with, or who have a 23 family history of, a birth defect or develop- 24 mental disability. 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 9 •HR 4393 IH (b) REPORT.— 1 (1) IN GENERAL.—The arrangement under sub- 2 section (a) shall provide for the National Academy 3 of Medicine to submit, not later than 6 years after 4 the date of enactment of this Act, a report on the 5 results of the study under subsection (a) to— 6 (A) the Secretary of Health and Human 7 Services; 8 (B) the Committee on Ways and Means 9 and the Committee on Energy and Commerce 10 of the House of Representatives; and 11 (C) the Committee on Finance and the 12 Committee on Health, Education, Labor, and 13 Pensions of the Senate. 14 (2) CONSULTATION.—The arrangement under 15 subsection (a) shall provide for the National Acad- 16 emy of Medicine, in developing the report required 17 by paragraph (1), to consult with physicians, other 18 health professionals, health educators, health profes- 19 sional organizations, relevant companies, patients, 20 patient organizations, the Health Resources and 21 Services Administration, the National Cancer Insti- 22 tute, the National Institutes of Health, the Agency 23 for Healthcare Research and Quality, and the Cen- 24 ters for Medicare & Medicaid Services. 25 VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS 10 •HR 4393 IH (3) USE OF INFORMATION.—The National 1 Academy of Medicine shall, to the extent possible, in 2 conducting the study under subsection (a), utilize in- 3 formation included in the reports submitted pursu- 4 ant to subsections (d) and (e) of section 1947 of the 5 Social Security Act (as added by section 2). 6 Æ VerDate Sep 11 2014 01:39 Sep 21, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H4393.IH H4393 kjohnson on DSK79L0C42 with BILLS