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 services 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 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. 

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 ‘‘Advancing Access to 

5 Precision Medicine Act’’. 


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1 SEC. 2. STATE OPTION TO PROVIDE DNA SEQUENCING 

2 CLINICAL SERVICES FOR CERTAIN CHIL3 DREN. 

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

5 et seq.) is amended by adding at the end the following 

6 new section: 

7 ‘‘SEC. 1947. STATE OPTION TO PROVIDE DNA SEQUENCING 

8 CLINICAL SERVICES FOR CERTAIN CHIL9 DREN. 

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 on the first day of the first fiscal quarter that 

16 begins on or after the date of the enactment of this sec17 tion, a State, at its option as a State plan amendment, 

18 may provide for medical assistance under this title to an 

19 eligible individual for purposes of providing the individual 

20 with DNA sequencing clinical services. 

21 ‘‘(b) PAYMENTS.— 

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

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

24 payments for the provision of DNA sequencing clin25 ical services to any eligible individual. Payments 

26 made to a health care provider for such services 


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1 shall be treated as medical assistance for purposes 

2 of section 1903(a), except that, during the first 8 

3 fiscal year quarters that the State plan amendment 

4 is in effect, the Federal medical assistance percent5 age applicable to such payments shall be equal to 75 

6 percent. 

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

8 in the State plan amendment the methodology the 

9 State will use for determining payment for the provi10 sion of DNA sequencing clinical services. Such meth11 odology for determining payment shall be established 

12 consistent with section 1902(a)(30)(A). 

13 ‘‘(3) PLANNING GRANTS.— 

14 ‘‘(A) IN GENERAL.—Beginning on the date 

15 described in subsection (a), the Secretary may 

16 award planning grants to States for purposes of 

17 developing a State plan amendment under this 

18 section. A planning grant awarded to a State 

19 under this paragraph shall remain available 

20 until expended. 

21 ‘‘(B) STATE CONTRIBUTION.—A State 

22 awarded a planning grant shall contribute an 

23 amount equal to the State percentage deter24 mined under section 1905(b) for each fiscal 

25 year for which the grant is awarded. 


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

2 in the State plan amendment a requirement for any hos3 pital that is a participating provider under the State plan 

4 (or a waiver of such plan) to establish procedures for re5 ferring any eligible individual who seeks or needs treat6 ment in a hospital emergency department to a health care 

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

8 provide DNA sequencing clinical services. 

9 ‘‘(d) REPORTS BY STATES.—Not later than three 

10 years after the date on which the State plan amendment 

11 under this section is approved, a State shall submit a re12 port to the Administrator of the Centers for Medicare & 

13 Medicaid Services and the Administrator of the Health 

14 Resources and Services Administration on— 

15 ‘‘(1) the extent to which DNA sequencing clin16 ical services reduce health disparities; and 

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

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

19 use of genetic and genomic testing that may improve 

20 clinical outcomes for eligible individuals enrolled in 

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

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

23 condition for receiving payment for DNA sequencing clin24 ical services provided to an eligible individual, a health 

25 care provider shall report to the State, in accordance with 


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1 such requirements as the Secretary shall specify, on all 

2 applicable measures for determining the quality of such 

3 services. 

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

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

6 individual’ means an individual who— 

7 ‘‘(A) is eligible for medical assistance 

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

9 ‘‘(B) is under the age of 21 (or, at the op10 tion 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 ‘‘(C) has been referred or admitted to a 

15 pediatric intensive care unit for a chronic or 

16 undiagnosed disease; 

17 ‘‘(D) has been seen by at least one medical 

18 specialist for such chronic or undiagnosed dis19 ease; and 

20 ‘‘(E) is suspected by at least one medical 

21 specialist to have a pediatric-onset genetic dis22 ease. 

23 ‘‘(2) DNA SEQUENCING CLINICAL SERVICES.— 

24 The term ‘DNA sequencing clinical services’, with 

25 respect to an eligible individual— 


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1 ‘‘(A) means a determination of an exact 

2 sequence of deoxyribonucleic acid bases in the 

3 genome of such individual, and, if for the sole 

4 benefit of the individual, a biological parent of 

5 such individual for the purpose of determining 

6 whether one or more potentially disease-causing 

7 genetic variants are present in the genome of 

8 such individual or such biological parent; and 

9 ‘‘(B) includes— 

10 ‘‘(i) sequencing of the entire genome, 

11 of the exome, of a panel of genes, or other 

12 regions of the genome; and 

13 ‘‘(ii) any analysis, interpretation, and 

14 data report derived from such sequenc15 ing.’’. 

16 SEC. 3. NATIONAL ACADEMY OF MEDICINE STUDY. 

17 (a) IN GENERAL.—Not later than 4 years after the 

18 date of the enactment of this Act, the Secretary of Health 

19 and Human Services shall enter into an arrangement with 

20 the National Academy of Medicine under which the Acad21 emy agrees to study— 

22 (1) how genetic and genomic testing may im23 prove preventative care and precision medicine; 

24 (2) how genetic and genomic testing may re25 duce health disparities; 


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1 (3) how the Federal Government may help to 

2 reduce barriers to genetic and genomic testing, in3 cluding— 

4 (A) encouraging the expansion of health 

5 insurance coverage of genetic and genomic test6 ing, including diagnostic, predictive, and pre7 symptomatic testing, and DNA sequencing clin8 ical services (as defined in section 1947 of the 

9 Social Security Act (as added by section 2)); 

10 (B) supporting the collection of evidence 

11 for the clinical utility and appropriate use of ge12 netic and genomic tests; and 

13 (C) improving access to genetic counselors, 

14 pathologists, and other relevant professions, in15 cluding strengthening related workforce edu16 cation and training efforts; 

17 (4)(A) the extent to which coverage provisions 

18 in the Medicare and Medicaid programs under titles 

19 XVIII and XIX of the Social Security Act (42 

20 U.S.C. 1395 et seq., 1396 et seq.) may restrain the 

21 use of genetic and genomic testing that may improve 

22 clinical outcomes for beneficiaries; 

23 (B) the extent to which coverage provided pur24 suant to section 1947 of the Social Security Act (as 

25 added by section 2) increased the use of genetic and 


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1 genomic testing and improved clinical outcomes for 

2 beneficiaries; and 

3 (C) how the Centers for Medicare & Medicaid 

4 Services may make coverage determinations that 

5 better suit a precision medicine approach to treat6 ment; and 

7 (5) how genetic and genomic testing may im8 prove health outcomes for all populations in the 

9 United States, including— 

10 (A) individuals with a rare disease, includ11 ing— 

12 (i) a metabolic disease; 

13 (ii) a hereditary cancer syndrome; and 

14 (iii) a neurologic disease with known 

15 treatments; and 

16 (B) special populations, including— 

17 (i) infants and children; 

18 (ii) critically ill (non-infectious and 

19 non-trauma) patients; 

20 (iii) transplant patients; 

21 (iv) individuals with cardiac disease; 

22 and 

23 (v) individuals with, or who have a 

24 family history of, a birth defect or develop25 mental disability. 


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1 (b) REPORT.— 

2 (1) IN GENERAL.—The arrangement under sub3 section (a) shall provide for the National Academy 

4 of Medicine to submit, not later than 6 years after 

5 the date of enactment of this Act, a report on the 

6 results of the study under subsection (a) to— 

7 (A) the Secretary of Health and Human 

8 Services; 

9 (B) the Committee on Ways and Means 

10 and the Committee on Energy and Commerce 

11 of the House of Representatives; and 

12 (C) the Committee on Finance and the 

13 Committee on Health, Education, Labor, and 

14 Pensions of the Senate. 

15 (2) CONSULTATION.—The arrangement under 

16 subsection (a) shall provide for the National Acad17 emy of Medicine, in developing the report required 

18 by paragraph (1), to consult with physicians, other 

19 health professionals, health educators, health profes20 sional organizations, relevant companies, patients, 

21 patient organizations, the Health Resources and 

22 Services Administration, the National Cancer Insti23 tute, the National Institutes of Health, the Agency 

24 for Healthcare Research and Quality, and the Cen25 ters for Medicare & Medicaid Services. 


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1 (3) USE OF INFORMATION.—The National 

2 Academy of Medicine shall, to the extent possible, in 

3 conducting the study under subsection (a), utilize in4 formation included in the reports submitted pursu5 ant to subsections (d) and (e) of section 1947 of the 

6 Social Security Act (as added by section 2). 

Æ 


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