[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4393 Introduced in House (IH)]

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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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advancing Access to Precision 
Medicine Act''.

SEC. 2. STATE OPTION TO PROVIDE DNA SEQUENCING CLINICAL SERVICES FOR 
              CERTAIN CHILDREN.

    Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is 
amended by adding at the end the following new section:

``SEC. 1947. STATE OPTION TO PROVIDE DNA SEQUENCING CLINICAL SERVICES 
              FOR CERTAIN CHILDREN.

    ``(a) In General.--Notwithstanding section 1902(a)(1) (relating to 
statewideness), section 1902(a)(10)(B) (relating to comparability), and 
any other provision of this title for which the Secretary determines it 
is necessary to waive in order to implement this section, beginning on 
the first day of the first fiscal quarter that begins on or after the 
date of the enactment of this section, a State, at its option as a 
State plan amendment, may provide for medical assistance under this 
title to an eligible individual for purposes of providing the 
individual with DNA sequencing clinical services.
    ``(b) Payments.--
            ``(1) In general.--A State shall provide a health care 
        provider (as defined by the State) with payments for the 
        provision of DNA sequencing clinical services to any eligible 
        individual. Payments made to a health care provider for such 
        services shall be treated as medical assistance for purposes of 
        section 1903(a), except that, during the first 8 fiscal year 
        quarters that the State plan amendment is in effect, the 
        Federal medical assistance percentage applicable to such 
        payments shall be equal to 75 percent.
            ``(2) Methodology.--The State shall specify in the State 
        plan amendment the methodology the State will use for 
        determining payment for the provision of DNA sequencing 
        clinical services. Such methodology for determining payment 
        shall be established consistent with section 1902(a)(30)(A).
            ``(3) Planning grants.--
                    ``(A) In general.--Beginning on the date described 
                in subsection (a), the Secretary may award planning 
                grants to States for purposes of developing a State 
                plan amendment under this section. A planning grant 
                awarded to a State under this paragraph shall remain 
                available until expended.
                    ``(B) State contribution.--A State awarded a 
                planning grant shall contribute an amount equal to the 
                State percentage determined under section 1905(b) for 
                each fiscal year for which the grant is awarded.
    ``(c) Hospital Referrals.--A State shall include in the State plan 
amendment a requirement for any hospital that is a participating 
provider under the State plan (or a waiver of such plan) to establish 
procedures for referring any eligible individual who seeks or needs 
treatment in a hospital emergency department to a health care provider 
who is qualified (as determined by the State) to provide DNA sequencing 
clinical services.
    ``(d) Reports by States.--Not later than three years after the date 
on which the State plan amendment under this section is approved, a 
State shall submit a report to the Administrator of the Centers for 
Medicare & Medicaid Services and the Administrator of the Health 
Resources and Services Administration on--
            ``(1) the extent to which DNA sequencing clinical services 
        reduce health disparities; and
            ``(2) the extent to which coverage under the State plan (or 
        a waiver of such plan) impedes the use of genetic and genomic 
        testing that may improve clinical outcomes for eligible 
        individuals enrolled in the State plan (or under a waiver of 
        such plan).
    ``(e) Reports by Health Care Providers.--As a condition for 
receiving payment for DNA sequencing clinical services provided to an 
eligible individual, a health care provider shall report to the State, 
in accordance with such requirements as the Secretary shall specify, on 
all applicable measures for determining the quality of such services.
    ``(f) Definitions.--In this section:
            ``(1) Eligible individual.--The term `eligible individual' 
        means an individual who--
                    ``(A) is eligible for medical assistance under the 
                State plan (or a waiver of such plan);
                    ``(B) is under the age of 21 (or, at the option of 
                the State, under the age of 20, 19, or 18 as the State 
                may choose), or in the case of an individual described 
                in section 1902(a)(10)(A)(i)(IX), under the age of 26;
                    ``(C) has been referred or admitted to a pediatric 
                intensive care unit for a chronic or undiagnosed 
                disease;
                    ``(D) has been seen by at least one medical 
                specialist for such chronic or undiagnosed disease; and
                    ``(E) is suspected by at least one medical 
                specialist to have a pediatric-onset genetic disease.
            ``(2) DNA sequencing clinical services.--The term `DNA 
        sequencing clinical services', with respect to an eligible 
        individual--
                    ``(A) means a determination of an exact sequence of 
                deoxyribonucleic acid bases in the genome of such 
                individual, and, if for the sole benefit of the 
                individual, a biological parent of such individual for 
                the purpose of determining whether one or more 
                potentially disease-causing genetic variants are 
                present in the genome of such individual or such 
                biological parent; and
                    ``(B) includes--
                            ``(i) sequencing of the entire genome, of 
                        the exome, of a panel of genes, or other 
                        regions of the genome; and
                            ``(ii) any analysis, interpretation, and 
                        data report derived from such sequencing.''.

SEC. 3. NATIONAL ACADEMY OF MEDICINE STUDY.

    (a) In General.--Not later than 4 years after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
enter into an arrangement with the National Academy of Medicine under 
which the Academy agrees to study--
            (1) how genetic and genomic testing may improve 
        preventative care and precision medicine;
            (2) how genetic and genomic testing may reduce health 
        disparities;
            (3) how the Federal Government may help to reduce barriers 
        to genetic and genomic testing, including--
                    (A) encouraging the expansion of health insurance 
                coverage of genetic and genomic testing, including 
                diagnostic, predictive, and presymptomatic testing, and 
                DNA sequencing clinical services (as defined in section 
                1947 of the Social Security Act (as added by section 
                2));
                    (B) supporting the collection of evidence for the 
                clinical utility and appropriate use of genetic and 
                genomic tests; and
                    (C) improving access to genetic counselors, 
                pathologists, and other relevant professions, including 
                strengthening related workforce education and training 
                efforts;
            (4)(A) the extent to which coverage provisions in the 
        Medicare and Medicaid programs under titles XVIII and XIX of 
        the Social Security Act (42 U.S.C. 1395 et seq., 1396 et seq.) 
        may restrain the use of genetic and genomic testing that may 
        improve clinical outcomes for beneficiaries;
            (B) the extent to which coverage provided pursuant to 
        section 1947 of the Social Security Act (as added by section 2) 
        increased the use of genetic and genomic testing and improved 
        clinical outcomes for beneficiaries; and
            (C) how the Centers for Medicare & Medicaid Services may 
        make coverage determinations that better suit a precision 
        medicine approach to treatment; and
            (5) how genetic and genomic testing may improve health 
        outcomes for all populations in the United States, including--
                    (A) individuals with a rare disease, including--
                            (i) a metabolic disease;
                            (ii) a hereditary cancer syndrome; and
                            (iii) a neurologic disease with known 
                        treatments; and
                    (B) special populations, including--
                            (i) infants and children;
                            (ii) critically ill (non-infectious and 
                        non-trauma) patients;
                            (iii) transplant patients;
                            (iv) individuals with cardiac disease; and
                            (v) individuals with, or who have a family 
                        history of, a birth defect or developmental 
                        disability.
    (b) Report.--
            (1) In general.--The arrangement under subsection (a) shall 
        provide for the National Academy of Medicine to submit, not 
        later than 6 years after the date of enactment of this Act, a 
        report on the results of the study under subsection (a) to--
                    (A) the Secretary of Health and Human Services;
                    (B) the Committee on Ways and Means and the 
                Committee on Energy and Commerce of the House of 
                Representatives; and
                    (C) the Committee on Finance and the Committee on 
                Health, Education, Labor, and Pensions of the Senate.
            (2) Consultation.--The arrangement under subsection (a) 
        shall provide for the National Academy of Medicine, in 
        developing the report required by paragraph (1), to consult 
        with physicians, other health professionals, health educators, 
        health professional organizations, relevant companies, 
        patients, patient organizations, the Health Resources and 
        Services Administration, the National Cancer Institute, the 
        National Institutes of Health, the Agency for Healthcare 
        Research and Quality, and the Centers for Medicare & Medicaid 
        Services.
            (3) Use of information.--The National Academy of Medicine 
        shall, to the extent possible, in conducting the study under 
        subsection (a), utilize information included in the reports 
        submitted pursuant to subsections (d) and (e) of section 1947 
        of the Social Security Act (as added by section 2).
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