[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1810 Reported in Senate (RS)]
Calendar No. 701
110th CONGRESS
2d 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 (for himself, Mr. Kennedy, and Mr. Dorgan) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
April 21, 2008
Reported by Mr. Kennedy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Prenatally and Postnatally
Diagnosed Conditions Awareness Act''.</DELETED>
<DELETED>SEC. 2. FINDINGS AND PURPOSES.</DELETED>
<DELETED> (a) Findings.--Congress makes the following
findings:</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (b) Purposes.--It is the purpose of this Act, after the
diagnosis of a fetus with Down syndrome or other prenatally diagnosed
conditions, to--</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (2) strengthen existing networks of support
through a Centers for Disease Control and Prevention patient
and provider outreach program;</DELETED>
<DELETED> (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</DELETED>
<DELETED> (4) ensure that patients receive up-to-date,
scientific information about the accuracy of the
test.</DELETED>
<DELETED>SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSITIVE TEST
DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY OR
POSTNATALLY DIAGNOSED CONDITIONS.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(4) Prenatally diagnosed condition.--The term
`prenatally diagnosed condition' means any fetal health
condition identified by prenatal genetic testing or prenatal
screening procedures.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Information and Support Services.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) collect, synthesize, and disseminate
current scientific information relating to Down
syndrome or other prenatally or postnatally diagnosed
conditions; and</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) the establishment of a
resource telephone hotline and Internet website
accessible to patients receiving a positive
test result;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Data Collection.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(e) Privacy.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) data that are not related to the
epidemiology of the condition being tested
for.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(f) Reports.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prenatally and Postnatally Diagnosed
Conditions Awareness Act''.
SEC. 2. PURPOSES.
It is the purpose of this Act to--
(1) increase patient referrals to providers of key support
services for women who have received a positive diagnosis for
Down syndrome, or other prenatally or postnatally diagnosed
conditions, as well as to provide up-to-date information on the
range of outcomes for individuals living with the diagnosed
condition, including physical, developmental, educational, and
psychosocial outcomes;
(2) strengthen existing networks of support through the
Centers for Disease Control and Prevention, the Health
Resources and Services Administration, and other patient and
provider outreach programs; and
(3) ensure that patients receive up-to-date, evidence-based
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 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 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) 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 eligible entities, to--
``(A) collect, synthesize, and disseminate current
evidence-based 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 diagnosis for Down syndrome or
other prenatally or postnatally diagnosed conditions,
including--
``(i) the establishment of a resource
telephone hotline accessible to patients
receiving a positive test result or to the
parents of newly diagnosed infants with Down
syndrome and other diagnosed conditions;
``(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
range of outcomes for individuals living with
the diagnosed condition, including physical,
developmental, educational, and psychosocial
outcomes;
``(iii) the expansion and further
development of national and local peer-support
programs, so that such programs can more
effectively serve women who receive a positive
diagnosis for Down syndrome or other prenatal
conditions or parents of infants with a
postnatally diagnosed condition;
``(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, interpret, or inform parents of
the results of prenatal 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) Eligible entity.--In this subsection, the term
`eligible entity' means--
``(A) a State or a political subdivision of a
State;
``(B) a consortium of 2 or more States or political
subdivisions of States;
``(C) a territory;
``(D) a health facility or program operated by or
pursuant to a contract with or grant from the Indian
Health Service; or
``(E) any other entity with appropriate expertise
in prenatally and postnatally diagnosed conditions
(including nationally recognized disability groups), as
determined by the Secretary.
``(3) Distribution.--In distributing funds under this
subsection, the Secretary shall place an emphasis on funding
partnerships between health care professional groups and
disability advocacy organizations.
``(c) Provision of Information to Providers.--
``(1) In general.--A grantee under this section shall make
available to health care providers of parents who receive a
prenatal or postnatal diagnosis the following:
``(A) Up-to-date, evidence-based, written
information concerning the range of outcomes for
individuals living with the diagnosed condition,
including physical, developmental, educational, and
psychosocial outcomes.
``(B) Contact information regarding support
services, including information hotlines specific to
Down syndrome or other prenatally or postnatally
diagnosed conditions, resource centers or
clearinghouses, national and local peer support groups,
and other education and support programs as described
in subsection (b)(2).
``(2) Informational requirements.--Information provided
under this subsection shall be--
``(A) culturally and linguistically appropriate as
needed by women receiving a positive prenatal diagnosis
or the family of infants receiving a postnatal
diagnosis; and
``(B) approved by the Secretary.
``(d) Report.--Not later than 2 years 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.
``(e) 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.''.
Calendar No. 701
110th CONGRESS
2d Session
S. 1810
_______________________________________________________________________
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.
_______________________________________________________________________
April 21, 2008
Reported with an amendment