I 
114TH CONGRESS 
1ST SESSION H. R. 3441 
To amend the Public Health Service Act to establish education programs 
for patients and health care providers regarding cell-free DNA prenatal 
screening, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 4, 2015 
Ms. HERRERA BEUTLER (for herself and Ms. ROYBAL-ALLARD) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To amend the Public Health Service Act to establish edu-
cation programs for patients and health care providers 
regarding cell-free DNA prenatal screening, and for other 
purposes. 
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 ‘‘Accurate Education 
for Prenatal Screenings Act’’. 
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SEC. 2. CELL-FREE DNA PRENATAL SCREENING EDU-
CATION PROGRAMS. 
Part B of title III of the Public Health Service Act 
is amended by inserting, after section 317T (42 U.S.C. 
247b–22), the following: 
‘‘SEC. 317U. CELL-FREE DNA PRENATAL SCREENING EDU-
CATION PROGRAMS. 
‘‘(a) EDUCATION PROGRAMS.—With respect to cell- 
free DNA prenatal screening, the Secretary, acting 
through the Director of the Centers for Disease Control 
and Prevention, shall develop, implement, and maintain 
two programs, one for patients and one for health care 
providers, to educate patients and health care providers 
regarding matters including— 
‘‘(1) the purposes and definitions of such 
screenings; 
‘‘(2) the reasons for patients and health care 
providers to consider such screenings; 
‘‘(3) the conditions such screenings may detect, 
including accurate and up-to-date information about 
such conditions’ clinical features, prognoses, and 
treatments according to relevant national disability 
organizations and medical professional societies; 
‘‘(4) the risks and benefits of, and alternatives 
to, the various methods of administering such 
screenings and prenatal diagnostic testings, includ-
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ing the option to forego such screenings and 
testings, as per guidelines established by medical 
professional societies; 
‘‘(5) the possible results of such screenings; 
‘‘(6) the accuracy of the results of such 
screenings, including positive predictive value, nega-
tive predictive value, specificity, sensitivity, the in-
ability of such screenings to reliably diagnose chro-
mosomal abnormalities, and the fact that such 
screenings may yield false-positive and false-negative 
results; 
‘‘(7) the need for diagnostic testing, and coun-
seling by a genetics professional, for patients whose 
screenings yield positive, abnormal, or indeterminate 
results; and 
‘‘(8) the need for communication of screening 
results to patients and appropriate follow up per 
guidelines established by medical professional soci-
eties. 
‘‘(b) MATERIALS.—Each program developed under 
this section shall include the provision of materials that— 
‘‘(1) contain information that is peer-reviewed, 
balanced, accurate, and up-to-date; 
‘‘(2) enable the respective target audience to 
understand the available options with regards to cell- 
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free DNA prenatal screenings, other prenatal 
screenings, and diagnostic tests; 
‘‘(3) promote the informed consent, and en-
hance the decision-making processes of, the respec-
tive 
target 
audience 
before 
and 
after 
such 
screenings; 
‘‘(4) contain information that appropriately ad-
dresses the diversity of the patient population, in-
cluding patients proficient in languages other than 
English; and 
‘‘(5) contain contact information for relevant 
services and support organizations for patients. 
‘‘(c) ASSESSMENT.—In developing, implementing, 
and maintaining programs and materials under this sec-
tion, the Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall— 
‘‘(1) consult with relevant medical professional, 
disability support, patient advocacy, parents, and ge-
netics professionals organizations; 
‘‘(2) consult with companies and laboratories 
that perform cell-free DNA prenatal screenings or 
develop the technologies for such screenings; 
‘‘(3) assess and evaluate existing education ac-
tivities and materials for health care providers and 
patients related to such screenings; and 
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‘‘(4) take the results of such consultations, as-
sessment, and evaluation into account in developing 
educational programs and materials under this sec-
tion. 
‘‘(d) ANNUAL REPORT.—Not later than 16 months 
after the date of enactment of this section and annually 
thereafter, the Secretary shall submit a progress report 
to the Congress with respect to— 
‘‘(1) the development and implementation of the 
education programs established under this section; 
‘‘(2) the accessibility of each program to its re-
spective target audience; 
‘‘(3) the adoption of each program by its re-
spective target audience; and 
‘‘(4) the Secretary’s efforts to ensure health 
care providers and patients receive the materials cre-
ated pursuant to this section. 
‘‘(e) DEADLINE.—The Secretary shall develop and 
implement the education programs required by section 
317U of the Public Health Service Act (as added by sub-
section (a)) not later than 1 year after the date of enact-
ment of this Act’’. 
Æ 
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