I 

115TH CONGRESS 

2D SESSION H. R. 5062 

To 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 

FEBRUARY 15, 2018 

Mr. SWALWELL of California (for himself, Mr. SHIMKUS, Mr. PETERS, Mr. 

PAULSEN, and Mr. VARGAS) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To 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’’. 

6 SEC. 2. NATIONAL ACADEMY OF MEDICINE STUDY. 

7 (a) IN GENERAL.—Not later than 60 days after the 

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

9 and Human Services shall enter into an arrangement with 


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1 the National Academy of Medicine under which the Acad2 emy agrees to study— 

3 (1) how genetic and genomic testing may im4 prove preventative care and precision medicine; 

5 (2) how genetic and genomic testing may re6 duce health disparities; 

7 (3) how the Federal Government may help to 

8 reduce barriers to genetic and genomic testing, in9 cluding— 

10 (A) encouraging the expansion of health 

11 insurance coverage of genetic and genomic test12 ing, including diagnostic, predictive, and pre13 symptomatic testing, and whole genome se14 quencing; 

15 (B) supporting the collection of evidence 

16 for the clinical utility and appropriate use of ge17 netic and genomic tests; and 

18 (C) improving access to genetic counselors, 

19 pathologists, and other relevant professions, in20 cluding strengthening related workforce edu21 cation and training efforts; 

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

23 in the Medicare and Medicaid programs under titles 

24 XVIII and XIX of the Social Security Act (42 

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


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1 use of genetic and genomic testing that may improve 

2 clinical outcomes for beneficiaries; and 

3 (B) 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 3 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 SEC. 3. 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, 2019, 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 21:55 Feb 26, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5062.IH H5062

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

2 first 8 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 2019, 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 21:55 Feb 26, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5062.IH H5062

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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 three 

8 years after the date on which the State plan amendment 

9 under this section is approved, a State shall submit a re10 port to the Administrator of the Centers for Medicare & 

11 Medicaid Services and the Administrator of the Health 

12 Resources 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 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 op9 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 dis18 ease; and 

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

20 specialist to have a pediatric-onset genetic dis21 ease. 

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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