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 education programs for patients and health care providers 

regarding cell-free DNA prenatal screening, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accurate Education 

5 for Prenatal Screenings Act’’. 

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1 SEC. 2. CELL-FREE DNA PRENATAL SCREENING EDU2 CATION PROGRAMS. 

3 Part B of title III of the Public Health Service Act 

4 is amended by inserting, after section 317T (42 U.S.C. 

5 247b–22), the following: 

6 ‘‘SEC. 317U. CELL-FREE DNA PRENATAL SCREENING EDU7 CATION PROGRAMS. 

8 ‘‘(a) EDUCATION PROGRAMS.—With respect to cell9 free DNA prenatal screening, the Secretary, acting 

10 through the Director of the Centers for Disease Control 

11 and Prevention, shall develop, implement, and maintain 

12 two programs, one for patients and one for health care 

13 providers, to educate patients and health care providers 

14 regarding matters including— 

15 ‘‘(1) the purposes and definitions of such 

16 screenings; 

17 ‘‘(2) the reasons for patients and health care 

18 providers to consider such screenings; 

19 ‘‘(3) the conditions such screenings may detect, 

20 including accurate and up-to-date information about 

21 such conditions’ clinical features, prognoses, and 

22 treatments according to relevant national disability 

23 organizations and medical professional societies; 

24 ‘‘(4) the risks and benefits of, and alternatives 

25 to, the various methods of administering such 

26 screenings and prenatal diagnostic testings, includmstockstill on DSK4VPTVN1PROD with BILLS

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1 ing the option to forego such screenings and 

2 testings, as per guidelines established by medical 

3 professional societies; 

4 ‘‘(5) the possible results of such screenings; 

5 ‘‘(6) the accuracy of the results of such 

6 screenings, including positive predictive value, nega7 tive predictive value, specificity, sensitivity, the in8 ability of such screenings to reliably diagnose chro9 mosomal abnormalities, and the fact that such 

10 screenings may yield false-positive and false-negative 

11 results; 

12 ‘‘(7) the need for diagnostic testing, and coun13 seling by a genetics professional, for patients whose 

14 screenings yield positive, abnormal, or indeterminate 

15 results; and 

16 ‘‘(8) the need for communication of screening 

17 results to patients and appropriate follow up per 

18 guidelines established by medical professional soci19 eties. 

20 ‘‘(b) MATERIALS.—Each program developed under 

21 this section shall include the provision of materials that— 

22 ‘‘(1) contain information that is peer-reviewed, 

23 balanced, accurate, and up-to-date; 

24 ‘‘(2) enable the respective target audience to 

25 understand the available options with regards to cellmstockstill on DSK4VPTVN1PROD with BILLS

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1 free DNA prenatal screenings, other prenatal 

2 screenings, and diagnostic tests; 

3 ‘‘(3) promote the informed consent, and en4 hance the decision-making processes of, the respec5 tive target audience before and after such 

6 screenings; 

7 ‘‘(4) contain information that appropriately ad8 dresses the diversity of the patient population, in9 cluding patients proficient in languages other than 

10 English; and 

11 ‘‘(5) contain contact information for relevant 

12 services and support organizations for patients. 

13 ‘‘(c) ASSESSMENT.—In developing, implementing, 

14 and maintaining programs and materials under this sec15 tion, the Secretary, acting through the Director of the 

16 Centers for Disease Control and Prevention, shall— 

17 ‘‘(1) consult with relevant medical professional, 

18 disability support, patient advocacy, parents, and ge19 netics professionals organizations; 

20 ‘‘(2) consult with companies and laboratories 

21 that perform cell-free DNA prenatal screenings or 

22 develop the technologies for such screenings; 

23 ‘‘(3) assess and evaluate existing education ac24 tivities and materials for health care providers and 

25 patients related to such screenings; and 

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1 ‘‘(4) take the results of such consultations, as2 sessment, and evaluation into account in developing 

3 educational programs and materials under this sec4 tion. 

5 ‘‘(d) ANNUAL REPORT.—Not later than 16 months 

6 after the date of enactment of this section and annually 

7 thereafter, the Secretary shall submit a progress report 

8 to the Congress with respect to— 

9 ‘‘(1) the development and implementation of the 

10 education programs established under this section; 

11 ‘‘(2) the accessibility of each program to its re12 spective target audience; 

13 ‘‘(3) the adoption of each program by its re14 spective target audience; and 

15 ‘‘(4) the Secretary’s efforts to ensure health 

16 care providers and patients receive the materials cre17 ated pursuant to this section. 

18 ‘‘(e) DEADLINE.—The Secretary shall develop and 

19 implement the education programs required by section 

20 317U of the Public Health Service Act (as added by sub21 section (a)) not later than 1 year after the date of enact22 ment of this Act’’. 

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