Title: Advancing Access to Precision Medicine Act
Policy area: Health

Summary:
Advancing Access to Precision Medicine Act
This bill requires the Department of Health and Human Services to enter into an arrangement with the National Academy of Medicine for the academy to study usage of genetic and genomic testing, including how to reduce barriers to the utilization of such testing.
The bill allows states to apply for an exception to Medicaid's federal medical assistance percentage rate to provide whole genome sequencing clinical services to certain children, including those admitted to a pediatric intensive care unit for a chronic or undiagnosed disease and those suspected to have a pediatric-onset genetic disease.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5062 Introduced in House (IH)]

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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.

    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. NATIONAL ACADEMY OF MEDICINE STUDY.

    (a) In General.--Not later than 60 days 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 
                whole genome sequencing;
                    (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; and
            (B) 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 3 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.

SEC. 3. STATE OPTION TO PROVIDE WHOLE GENOME SEQUENCING CLINICAL 
              SERVICES FOR CERTAIN CHILDREN.

    Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is 
amended by inserting after section 1943 the following new section:

``SEC. 1944. STATE OPTION TO PROVIDE WHOLE GENOME 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 
January 1, 2019, 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 whole genome 
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 whole genome 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 whole genome 
        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 January 1, 2019, 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 whole genome 
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 whole genomic 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 whole genome 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) Whole genome sequencing clinical services.--The term 
        `whole genome sequencing clinical services', with respect to an 
        eligible individual--
                    ``(A) means the unbiased sequencing of all 
                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 any analysis, interpretation, and 
                data report derived from such sequencing.''.
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