1.
This Act may be cited as the
Prenatally Diagnosed Condition
Awareness Act
.
2.
(a)
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)
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 diagnosed conditions, as well
as to provide up-to-date, science-based information about life-expectancy,
development potential, and quality of life for a child born with Down syndrome
or other prenatally diagnosed condition;
(2)
provide 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 testing into existing
State-based surveillance programs for birth defects and prenatally diagnosed
conditions; and
(4)
ensure that patients receive
up-to-date, scientific information about the accuracy of the test.
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:
399O.
Support for patients receiving a positive test diagnosis of
Down syndrome or other prenatally diagnosed conditions
(a)
In this section:
(1)
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)
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)
Prenatally diagnosed condition
The term prenatally
diagnosed condition means any fetal health condition identified by
prenatal genetic testing or prenatal screening procedures.
(4)
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
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—
(1)
collect, synthesize, and
disseminate current scientific information relating to Down syndrome or other
prenatally diagnosed conditions; and
(2)
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 diagnosed
conditions, including—
(A)
the establishment of a
resource telephone hotline and Internet website accessible to patients
receiving a positive test result;
(B)
the establishment of a
clearinghouse of scientific information, clinical course, life expectancy,
development potential, and quality of life relating to Down syndrome or other
prenatally diagnosed conditions;
(C)
the establishment of
national and local peer-support programs;
(D)
the establishment of a
national registry, or network of local registries, of families willing to adopt
newborns with Down syndrome or other prenatally diagnosed conditions, and links
to adoption agencies willing to place babies with Down syndrome or other
prenatally diagnosed conditions, with families willing to adopt; and
(E)
the establishment of
awareness and education programs for health care providers who provide the
results of prenatal tests for Down syndrome or other prenatally diagnosed
conditions, to patients, consistent with the purpose described in section
2(b)(1) of the Prenatal Diagnosis Support Act.
(c)
(1)
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 testing into State-based vital statistics and birth defects
surveillance programs.
(2)
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
testing.
(d)
Provision of information by providers
Upon receipt of a positive
test result from a prenatal test for Down syndrome or other prenatally
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 diagnosed
conditions.
(2)
Referral to supportive
services providers, including information hotlines specific to Down syndrome or
other prenatally diagnosed conditions, resource centers or clearinghouses, and
other education and support programs as described in subsection (b)(2).
(e)
(1)
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)
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)
(1)
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)
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
2006 through 2010.
.