[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1810 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 1810
To amend the Public Health Service Act to increase the provision of
scientifically sound information and support services to patients
receiving a positive test diagnosis for Down syndrome or other
prenatally and postnatally diagnosed conditions.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 18 (legislative day, July 17), 2007
Mr. Brownback introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to increase the provision of
scientifically sound information and support services to patients
receiving a positive test diagnosis for Down syndrome or other
prenatally and postnatally diagnosed conditions.
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 ``Prenatally and Postnatally Diagnosed
Conditions Awareness Act''.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--Congress makes the following findings:
(1) Pregnant women who choose to undergo prenatal genetic
testing should have access to timely, scientific, and
nondirective counseling about the conditions being tested for
and the accuracy of such tests, from health care professionals
qualified to provide and interpret these tests. Informed
consent is a critical component of all genetic testing.
(2) A recent, peer-reviewed study and two reports from the
Centers for Disease Control and Prevention on prenatal testing
found a deficiency in the data needed to understand the
epidemiology of prenatally diagnosed conditions, to monitor
trends accurately, and to increase the effectiveness of health
intervention.
(b) Purposes.--It is the purpose of this Act, after the diagnosis
of a fetus with Down syndrome or other prenatally diagnosed conditions,
to--
(1) increase patient referrals to providers of key support
services for women who have received a positive test diagnosis
for Down syndrome, or other prenatally or postnatally diagnosed
conditions, as well as to provide up-to-date, comprehensive
information about life expectancy, development potential, and
quality of life for a child born with Down syndrome or other
prenatally or postnatally diagnosed condition;
(2) strengthen existing networks of support through a
Centers for Disease Control and Prevention patient and provider
outreach program;
(3) improve available data by incorporating information
directly revealed by prenatal or postnatal testing into
existing State-based surveillance programs for birth defects
and prenatally or postnatally diagnosed conditions; and
(4) ensure that patients receive up-to-date, scientific
information about the accuracy of the test.
SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSITIVE TEST DIAGNOSIS
OF DOWN SYNDROME OR OTHER PRENATALLY OR POSTNATALLY
DIAGNOSED CONDITIONS.
``(a) Definitions.--In this section:
``(1) Down syndrome.--The term `Down syndrome' refers to a
chromosomal disorder caused by an error in cell division that
results in the presence of an extra whole or partial copy of
chromosome 21.
``(2) Health care provider.--The term `health care
provider' means any person or entity required by State or
Federal law or regulation to be licensed, registered, or
certified to provide health care services, and who is so
licensed, registered, or certified.
``(3) Postnatally diagnosed condition.--The term
`postnatally diagnosed condition' means any health condition
identified by postnatal genetic testing or postnatal screening
procedures during the 12-month period beginning at birth.
``(4) Prenatally diagnosed condition.--The term `prenatally
diagnosed condition' means any fetal health condition
identified by prenatal genetic testing or prenatal screening
procedures.
``(5) Postnatal test.--The term `postnatal test' means
diagnostic or screening tests offered with respect to an
individual from birth to 1 year of age that is administered on
a required or recommended basis by a health care provider based
on medical history, family background, ethnic background,
previous test results, symptoms the child is presenting, or
other risk factors.
``(6) Prenatal test.--The term `prenatal test' means
diagnostic or screening tests offered to pregnant women seeking
routine prenatal care that are administered on a required or
recommended basis by a health care provider based on medical
history, family background, ethnic background, previous test
results, or other risk factors.
``(b) Information and Support Services.--
``(1) In general.--The Secretary, acting through the
Director of the National Institutes of Health, the Director of
the Centers for Disease Control and Prevention, or the
Administrator of the Health Resources and Services
Administration, may authorize and oversee certain activities,
including the awarding of grants, contracts or cooperative
agreements, to--
``(A) collect, synthesize, and disseminate current
scientific information relating to Down syndrome or
other prenatally or postnatally diagnosed conditions;
and
``(B) coordinate the provision of, and access to,
new or existing supportive services for patients
receiving a positive test diagnosis for Down syndrome
or other prenatally or postnatally diagnosed
conditions, including--
``(i) the establishment of a resource
telephone hotline and Internet website
accessible to patients receiving a positive
test result;
``(ii) the expansion and further
development of the National Dissemination
Center for Children with Disabilities, so that
such Center can more effectively conduct
outreach to new and expecting parents and
provide them with up-to-date information on the
clinical course, life expectancy, development
potential, quality of life, and available
resources and services for children with Down
syndrome or other prenatally and postnatally
diagnosed conditions;
``(iii) the expansion and further
development of national and local peer-support
programs, so that such programs can more
effectively serve parents of newly diagnosed
children;
``(iv) the establishment of a national
registry, or network of local registries, of
families willing to adopt newborns with Down
syndrome or other prenatally or postnatally
diagnosed conditions, and links to adoption
agencies willing to place babies with Down
syndrome or other prenatally or postnatally
diagnosed conditions, with families willing to
adopt; and
``(v) the establishment of awareness and
education programs for health care providers
who provide the results of prenatal or
postnatal tests for Down syndrome or other
prenatally or postnatally diagnosed conditions,
to patients, consistent with the purpose
described in section 2(b)(1) of the Prenatally
and Postnatally Diagnosed Conditions Awareness
Act.
``(2) Distribution.--In distributing funds under this
subsection, the Secretary shall place an emphasis on funding
partnerships between health care groups and disability advocacy
organizations.
``(c) Data Collection.--
``(1) Provision of assistance.--The Secretary, acting
through the Director of Centers for Disease Control and
Prevention, shall provide assistance to State and local health
departments to integrate the results of prenatal or postnatal
testing into State-based vital statistics and birth defects
surveillance programs.
``(2) Activities.--The Secretary shall ensure that
activities carried out under paragraph (1) are sufficient to
extract population-level data relating to national rates and
results of prenatal or postnatal testing.
``(3) Informed consent.--Prior to the reporting of the
results of a prenatal or postnatal test to a State or local
public health department under this subsection, the patient
involved shall be provided with a disclosure statement that
describes the manner in which the results of such tests will be
used. Such results may not be reported unless the patient
consents to such reporting after receipt of such disclosure
statement.
``(d) Provision of Information by Providers.--Upon receipt of a
positive test result from a prenatal or postnatal test for Down
syndrome or other prenatally or postnatally diagnosed conditions
performed on a patient, the health care provider involved (or his or
her designee) shall provide the patient with the following:
``(1) Up-to-date, scientific, written information
concerning the life expectancy, clinical course, and
intellectual and functional development and treatment options
for a fetus diagnosed with or child born with Down syndrome or
other prenatally or postnatally diagnosed conditions.
``(2) Referral to supportive services providers, including
information hotlines specific to Down syndrome or other
prenatally or postnatally diagnosed conditions, resource
centers or clearinghouses, and other education and support
programs as described in subsection (b)(2).
``(e) Privacy.--
``(1) In general.--Notwithstanding subsections (c) and (d),
nothing in this section shall be construed to permit or require
the collection, maintenance, or transmission, without the
health care provider obtaining the prior, written consent of
the patient, of--
``(A) health information or data that identify a
patient, or with respect to which there is a reasonable
basis to believe the information could be used to
identify the patient (including a patient's name,
address, healthcare provider, or hospital); and
``(B) data that are not related to the epidemiology
of the condition being tested for.
``(2) Guidance.--Not later than 180 days after the date of
enactment of this section, the Secretary shall establish
guidelines concerning the implementation of paragraph (1) and
subsection (d).
``(f) Reports.--
``(1) Implementation report.--Not later than 2 years after
the date of enactment of this section, and every 2 years
thereafter, the Secretary shall submit a report to Congress
concerning the implementation of the guidelines described in
subsection (e)(2).
``(2) GAO report.--Not later than 1 year after the date of
enactment of this section, the Government Accountability Office
shall submit a report to Congress concerning the effectiveness
of current healthcare and family support programs serving as
resources for the families of children with disabilities.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $5,000,000 for each of fiscal
years 2008 through 2012.''.
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