I 
109TH CONGRESS 
1ST SESSION H. R. 1353 
To amend the Public Health Service Act to increase the provision of scientif-
ically sound information and support services to patients receiving a 
positive test diagnosis for Down syndrome or other prenatally diagnosed 
conditions. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 16, 2005 
Mr. SENSENBRENNER (for himself, Mr. SESSIONS, and Mr. HOSTETTLER) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
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 diagnosed condi-
tions. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prenatally Diagnosed 
Condition Awareness Act’’.
SEC. 2. FINDINGS AND PURPOSES. 
(a) FINDINGS.—Congress makes the following find-
ings: 
(1) Pregnant women who choose to undergo 
prenatal genetic testing should have access to timely, 
scientific, and nondirective counseling about the con-
ditions being tested for and the accuracy of such 
tests, from health care professionals qualified to pro-
vide and interpret these tests. Informed consent is a 
critical component of all genetic testing. 
(2) A recent, peer-reviewed study and two re-
ports from the Centers for Disease Control and Pre-
vention on prenatal testing found a deficiency in the 
data needed to understand the epidemiology of pre-
natally diagnosed conditions, to monitor trends accu-
rately, 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 pre-
natally 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-ex-
pectancy, development potential, and quality of life
for a child born with Down syndrome or other pre-
natally diagnosed condition; 
(2) provide networks of support through a Cen-
ters for Disease Control and Prevention patient and 
provider outreach program; 
(3) improve available data by incorporating in-
formation 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, sci-
entific 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. 399O. SUPPORT FOR PATIENTS RECEIVING A POSI-
TIVE TEST DIAGNOSIS OF DOWN SYNDROME 
OR OTHER PRENATALLY DIAGNOSED CONDI-
TIONS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) DOWN SYNDROME.—The term ‘Down syn-
drome’ 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 re-
quired 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) 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 his-
tory, family background, ethnic background, pre-
vious test results, or other risk factors. 
‘‘(b) INFORMATION AND SUPPORT SERVICES.—The 
Secretary, acting through the Director of the National In-
stitutes of Health, the Director of the Centers for Disease 
Control and Prevention, or the Administrator of the 
Health Resources and Services Administration, may au-
thorize and oversee certain activities, including the award-
ing 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 re-
ceiving a positive test diagnosis for Down syndrome 
or other prenatally diagnosed conditions, including— 
‘‘(A) the establishment of a resource tele-
phone hotline and Internet website accessible to 
patients receiving a positive test result; 
‘‘(B) the establishment of a clearinghouse 
of scientific information, clinical course, life ex-
pectancy, development potential, and quality of 
life relating to Down syndrome or other pre-
natally diagnosed conditions; 
‘‘(C) the establishment of national and 
local peer-support programs; 
‘‘(D) the establishment of a national reg-
istry, 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 ba-
bies 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 pur-
pose described in section 2(b)(1) of the Pre-
natal Diagnosis Support Act. 
‘‘(c) DATA COLLECTION.— 
‘‘(1) PROVISION
OF
ASSISTANCE.—The Sec-
retary, acting through the Director of Centers for 
Disease Control and Prevention, shall provide assist-
ance to State and local health departments to inte-
grate the results of prenatal testing into State-based 
vital statistics and birth defects surveillance pro-
grams. 
‘‘(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 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 condi-
tions performed on a patient, the health care provider in-
volved (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 treat-
ment options for a fetus diagnosed with or child 
born with Down syndrome or other prenatally diag-
nosed conditions. 
‘‘(2) Referral to supportive services providers, 
including information hotlines specific to Down syn-
drome or other prenatally diagnosed conditions, re-
source centers or clearinghouses, and other edu-
cation and support programs as described in sub-
section (b)(2). 
‘‘(e) PRIVACY.— 
‘‘(1) 
IN
GENERAL.—Notwithstanding 
sub-
sections (c) and (d), nothing in this section shall be 
construed to permit or require the collection, mainte-
nance, or transmission, without the health care pro-
vider obtaining the prior, written consent of the pa-
tient, of— 
‘‘(A) health information or data that iden-
tify 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 epi-
demiology of the condition being tested for. 
‘‘(2) GUIDANCE.—Not later than 180 days 
after the date of enactment of this section, the Sec-
retary shall establish guidelines concerning the im-
plementation of paragraph (1) and subsection (d). 
‘‘(f) REPORTS.— 
‘‘(1) IMPLEMENTATION
REPORT.—Not later 
than 2 years after the date of enactment of this sec-
tion, and every 2 years thereafter, the Secretary 
shall submit a report to Congress concerning the im-
plementation of the guidelines described in sub-
section (e)(2). 
‘‘(2) GAO REPORT.—Not later than 1 year 
after the date of enactment of this section, the Gov-
ernment 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 disabil-
ities. 
‘‘(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.’’. 
Æ