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.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5989 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 5989
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 16, 2021
Mr. Swalwell (for himself, Mr. Peters, and Mr. Emmer) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Ways and Means, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
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.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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