Precision Medicine Answers for Kids Today Act
Bill: H.R.5989 | Sponsor: Rep. Swalwell, Eric (D-CA)
Policy area: Health

Summary:
Precision Medicine Answers for Kids Today Act
This bill establishes programs and requires reporting relating to Medicaid coverage of genetic and genomic testing, particularly for children.
Specifically, the bill establishes a demonstration program for up to 15 state Medicaid programs to cover genetic and genomic testing for certain individuals under the age of 21 (or a lower age, if the state chooses) and for former foster youth under the age of 26.
Additionally, the Centers for Medicare & Medicaid Services must report on overall Medicaid coverage of such services and issue guidance for states on ways to increase coverage for children; the National Academy of Medicine must study the impact of this guidance as well as the general utility of genetic and genomic testing.

To require the Secretary of Health and Human Services to conduct a 
   demonstration program to genetic and genomic testing for certain 
children, to provide for a study by the National Academy of Medicine on 
the use of such 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 ``Precision Medicine Answers for Kids 
Today Act''.

SEC. 2. CENTERS FOR MEDICARE & MEDICAID SERVICES GUIDANCE ON THE EARLY 
              AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT 
              BENEFIT.

    Not later than 6 months after the date of enactment of this Act, 
the Centers for Medicare & Medicaid Services shall issue guidance to 
States on authority and requirements under the Medicaid program under 
title XIX of the Social Security Act to provide medically necessary 
health care that falls within the scope of services specified under 
section 1905(r) of the Social Security Act (42 U.S.C. 1396d(r)) to a 
child, regardless of whether the service is available for adults under 
the State plan (or waiver of such plan) under such title. The guidance 
shall--
            (1) include technical and educational assistance on how to 
        increase the frequency of coverage under the State plan (or 
        waiver) pursuant to paragraphs (4) and (16) of section 1905(a) 
        of such Act (42 U.S.C. 1396d(a)) for genetic and genomic 
        testing diagnostic services, including whole exome sequencing, 
        whole genome sequencing, and gene panels when recommended by a 
        qualified treating provider as a first- or second-tier test for 
        pediatric patients, including those who--
                    (A) have a positive result from a newborn screening 
                program;
                    (B) have one or more neurodevelopmental or 
                congenital anomalies;
                    (C) are experiencing developmental delay or 
                intellectual disability;
                    (D) are having seizures;
                    (E) have been referred or admitted to a pediatric 
                or neonatal intensive care unit for a chronic or 
                undiagnosed disease;
                    (F) have been seen by at least one medical 
                specialist for such chronic or undiagnosed disease; or
                    (G) are suspected by at least one healthcare 
                provider to have a neonatal- or pediatric-onset genetic 
                disease;
            (2) provide education and support to providers to minimize 
        denials of claims for medical assistance under the State plan 
        under title XIX of the Social Security Act resulting from 
        deficient or inadequate paperwork; and
            (3) ensure that providers and Medicaid-eligible children 
        and the families are aware of the Early and Periodic Screening, 
        Diagnostic and Treatment Benefit under title XIX of the Social 
        Security Act and have access to required screenings and 
        necessary treatment services.

SEC. 3. DEMONSTRATION PROGRAM TO PROVIDE GENETIC AND GENOMIC TESTING 
              FOR CERTAIN CHILDREN.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into agreements with up to 15 States submitting applications 
under subsection (c) for the purpose of conducting, in accordance with 
this section, 3-year demonstration projects under section 1115 of the 
Social Security Act (42 U.S.C. 1315) in such States during the 3-year 
period beginning on the first date of the first fiscal quarter than 
begins on or after the date of the enactment of this section to test 
and evaluate the provision of medical assistance under the State plans 
under title XIX of such Act (or waivers of such plans) to eligible 
individuals for purposes of providing such individuals with genetic and 
genomic testing.
    (b) Demonstration Project Payment Requirements.--Under each 
demonstration project under this section conducted by a State, the 
following shall apply:
            (1) The State shall provide a health care provider (as 
        defined by the State) with payments for the provision of 
        genetic and genomic testing 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) of the Social Security Act (42 U.S.C. 1396b(a)), except 
        that the Federal medical assistance percentage applicable to 
        such payments shall be equal to 100 percent.
            (2) The State shall specify the methodology the State will 
        use for determining payment for the provision of genetic and 
        genomic testing. Such methodology for determining payment shall 
        be established consistent with section 1902(a)(30)(A) of such 
        Act (42 U.S.C. 1396a(a)(30)(A)).
    (c) Applications.--
            (1) In general.--A State desiring to enter into an 
        agreement under subsection (a) with the Secretary for 
        conducting a demonstration project shall submit to the 
        Secretary an application, in accordance with such form and 
        manner, and application priorities, as specified by the 
        Secretary and that at a minimum includes the following:
                    (A) An explanation of how and the extent to which 
                genetic and genomic testing under the demonstration 
                project of the State will provide information and data 
                on how such services improve the diagnosis of eligible 
                individuals.
                    (B) An explanation of how and the extent to which 
                coverage under the State plan (or waiver) pursuant to 
                the demonstration project will increase the use of 
                genetic and genomic testing that may increase the use 
                of genetic and genomic testing that may improve 
                clinical outcomes for eligible individuals.
                    (C) 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 
                genetic and genomic testing.
                    (D) An explanation of how genetic and genomic 
                testing may improve health outcomes for all populations 
                in the State, including--
                            (i) individuals with a rare genetic 
                        disease, including a metabolic disease, 
                        neurologic disorders, or hereditary cancer 
                        testing in the presence of a suspected or 
                        confirmed cancer diagnosis; and
                            (ii) special populations, including infants 
                        and children who are critically ill (non-
                        infectious and non-trauma) patients, transplant 
                        patients, individuals with cardiac disease, and 
                        individuals with, or who have a family history 
                        of, a birth defect or developmental disability.
            (2) Preferences in considering applications.--In 
        considering applications submitted under paragraph (1), the 
        Secretary of Health and Human Services shall give preference to 
        States that can demonstrate underutilization of genetic and 
        genomic sequencing clinical services (with priority given to 
        States that do not cover whole-genome sequencing or do not 
        cover the majority of genetic and genomic clinical services) in 
        pediatric populations under the State plan under title XIX of 
        the Social Security Act (or waiver of such plan).
    (d) Technical Assistance.--The Secretary of Health and Human 
Services shall provide technical assistance to assist States in 
planning and designing the demonstration project for purposes of 
applying for conducting such project under this section.
    (e) Reports by States.--Not later than one year after the date on 
which a State enters into an agreement under subsection (a) with the 
Secretary for conducting a demonstration project, the 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 the extent to which genetic and genomic 
testing improved outcomes and reduced health disparities. Such report 
shall include information on the number of patients receiving genetic 
and genomic testing, the types of services provided, and such other 
information as the Secretary shall prescribe.
    (f) Reports by Health Care Providers.--As a condition for receiving 
payment for genetic and genomic testing provided to an eligible 
individual under a demonstration project conducted by a State under 
this section, 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 and efficacy of 
such services.
    (g) Definitions.--In this section:
            (1) Eligible individual.--The term ``eligible individual'' 
        means, with respect to a State, an individual who--
                    (A) is eligible for medical assistance under the 
                State plan under title XIX of the Social Security Act 
                (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) of such Act (42 U.S.C. 
                1396a(a)(10)(A)(i)(IX)), under the age of 26;
                    (C) has been referred or admitted to an intensive 
                care unit, or has been seen by at least one medical 
                specialist, for a suspected genetic or undiagnosed 
                disease; or
                    (D) is suspected by at least one medical specialist 
                to have a neonatal-onset or pediatric-onset genetic 
                disease.
            (2) Genetic and genomic testing.--The term ``genetic and 
        genomic testing'', with respect to an eligible individual--
                    (A) means the determination of a 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) the sequencing of the whole genome, the 
                        whole exome, or a panel of genes; and
                            (ii) any analysis, interpretation, and data 
                        report derived from such sequencing.

SEC. 4. NATIONAL ACADEMY OF MEDICINE STUDY.

    (a) In General.--Not later than one year 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) disparities in access to precision diagnostics and 
        associated therapeutics;
            (3) how genetic and genomic testing may be used to reduce 
        health disparities in marginalized communities;
            (4) 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 
                genetic and genomic testing (as defined in section 
                2(h)(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;
            (5)(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 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
            (6) how genetic and genomic testing may improve health 
        outcomes for all pediatric populations in the United States, 
        including--
                    (A) children with a rare disease, including a 
                metabolic disease, neurologic disorder, or hereditary 
                cancer testing in the presence of a suspected or 
                confirmed cancer diagnosis; and
                    (B) special populations, including--
                            (i) critically ill (non-infectious and non-
                        trauma) patients;
                            (ii) transplant patients;
                            (iii) individuals with cardiac disease; and
                            (iv) 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 2 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 (f) and (g) of section 2.

SEC. 5. CENTERS FOR MEDICARE & MEDICAID SERVICES REPORT ON MEDICAID 
              COVERAGE FOR GENETIC AND GENOMIC TESTING.

    Not later than one year after the date of the enactment of this 
Act, and annually thereafter for the subsequent 3 years, the Centers 
for Medicare & Medicaid Services shall submit to the Secretary of 
Health and Human Services, the Committees on Ways and Means and on 
Energy and Commerce of the House of Representatives, and the Committees 
on Finance and Health, Education, Labor, and Pensions of the Senate a 
report on the extent to which each of the 50 States provide coverage 
under the State plan under title XIX of the Social Security Act (or 
waiver of such plan) of genetic and genomic testing (as defined in 
section 2(f)(2)) (including whole exome, whole genome, gene panels, 
single gene tests, Chromosomal microarray analysis, Fluorescence in 
situ hybridization, and other genetic and genomic tests), including 
information on--
            (1) how often genetic and genomic diagnostic testing 
        services are covered and reimbursed;
            (2) the frequency of denials for coverage and the rationale 
        for denying coverage;
            (3) an analysis of which genetic and genomic diagnostic 
        tests are being approved or denied;
            (4) how often test genetic counseling is covered pre- and 
        post-genetic and genomic diagnostic testing;
            (5) the turn-around time for prior authorization requests; 
        and
            (6) any barriers to coverage of genetic and genomic testing 
        services identified.
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