I 

109TH CONGRESS 

1ST SESSION H. R. 1353 

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 

conditions. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 16, 2005 

Mr. SENSENBRENNER (for himself, Mr. SESSIONS, and Mr. HOSTETTLER) introduced the following bill; which was referred to the Committee on Energy 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 conditions. 

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 ‘‘Prenatally Diagnosed 

5 Condition Awareness Act’’. 
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1 SEC. 2. FINDINGS AND PURPOSES. 

2 (a) FINDINGS.—Congress makes the following find3 ings: 

4 (1) Pregnant women who choose to undergo 

5 prenatal genetic testing should have access to timely, 

6 scientific, and nondirective counseling about the con7 ditions being tested for and the accuracy of such 

8 tests, from health care professionals qualified to pro9 vide and interpret these tests. Informed consent is a 

10 critical component of all genetic testing. 

11 (2) A recent, peer-reviewed study and two re12 ports from the Centers for Disease Control and Pre13 vention on prenatal testing found a deficiency in the 

14 data needed to understand the epidemiology of pre15 natally diagnosed conditions, to monitor trends accu16 rately, and to increase the effectiveness of health 

17 intervention. 

18 (b) PURPOSES.—It is the purpose of this Act, after 

19 the diagnosis of a fetus with Down syndrome or other pre20 natally diagnosed conditions, to— 

21 (1) increase patient referrals to providers of key 

22 support services for women who have received a 

23 positive test diagnosis for Down syndrome, or other 

24 prenatally diagnosed conditions, as well as to provide 

25 up-to-date, science-based information about life-ex26 pectancy, development potential, and quality of life 
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1 for a child born with Down syndrome or other pre2 natally diagnosed condition; 

3 (2) provide networks of support through a Cen4 ters for Disease Control and Prevention patient and 

5 provider outreach program; 

6 (3) improve available data by incorporating in7 formation directly revealed by prenatal testing into 

8 existing State-based surveillance programs for birth 

9 defects and prenatally diagnosed conditions; and 

10 (4) ensure that patients receive up-to-date, sci11 entific information about the accuracy of the test. 

12 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

13 ACT. 

14 Part P of title III of the Public Health Service Act 

15 (42 U.S.C. 280g et seq.) is amended by adding at the end 

16 the following: 

17 ‘‘SEC. 399O. SUPPORT FOR PATIENTS RECEIVING A POSI18 TIVE TEST DIAGNOSIS OF DOWN SYNDROME 

19 OR OTHER PRENATALLY DIAGNOSED CONDI20 TIONS. 

21 ‘‘(a) DEFINITIONS.—In this section: 

22 ‘‘(1) DOWN SYNDROME.—The term ‘Down syn23 drome’ refers to a chromosomal disorder caused by 

24 an error in cell division that results in the presence 

25 of an extra whole or partial copy of chromosome 21. 
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1 ‘‘(2) HEALTH CARE PROVIDER.—The term 

2 ‘health care provider’ means any person or entity re3 quired by State or Federal law or regulation to be 

4 licensed, registered, or certified to provide health 

5 care services, and who is so licensed, registered, or 

6 certified. 

7 ‘‘(3) PRENATALLY DIAGNOSED CONDITION.— 

8 The term ‘prenatally diagnosed condition’ means any 

9 fetal health condition identified by prenatal genetic 

10 testing or prenatal screening procedures. 

11 ‘‘(4) PRENATAL TEST.—The term ‘prenatal 

12 test’ means diagnostic or screening tests offered to 

13 pregnant women seeking routine prenatal care that 

14 are administered on a required or recommended 

15 basis by a health care provider based on medical his16 tory, family background, ethnic background, pre17 vious test results, or other risk factors. 

18 ‘‘(b) INFORMATION AND SUPPORT SERVICES.—The 

19 Secretary, acting through the Director of the National In20 stitutes of Health, the Director of the Centers for Disease 

21 Control and Prevention, or the Administrator of the 

22 Health Resources and Services Administration, may au23 thorize and oversee certain activities, including the award24 ing of grants, contracts or cooperative agreements, to— 
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1 ‘‘(1) collect, synthesize, and disseminate current 

2 scientific information relating to Down syndrome or 

3 other prenatally diagnosed conditions; and 

4 ‘‘(2) coordinate the provision of, and access to, 

5 new or existing supportive services for patients re6 ceiving a positive test diagnosis for Down syndrome 

7 or other prenatally diagnosed conditions, including— 

8 ‘‘(A) the establishment of a resource tele9 phone hotline and Internet website accessible to 

10 patients receiving a positive test result; 

11 ‘‘(B) the establishment of a clearinghouse 

12 of scientific information, clinical course, life ex13 pectancy, development potential, and quality of 

14 life relating to Down syndrome or other pre15 natally diagnosed conditions; 

16 ‘‘(C) the establishment of national and 

17 local peer-support programs; 

18 ‘‘(D) the establishment of a national reg19 istry, or network of local registries, of families 

20 willing to adopt newborns with Down syndrome 

21 or other prenatally diagnosed conditions, and 

22 links to adoption agencies willing to place ba23 bies with Down syndrome or other prenatally 

24 diagnosed conditions, with families willing to 

25 adopt; and 
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1 ‘‘(E) the establishment of awareness and 

2 education programs for health care providers 

3 who provide the results of prenatal tests for 

4 Down syndrome or other prenatally diagnosed 

5 conditions, to patients, consistent with the pur6 pose described in section 2(b)(1) of the Pre7 natal Diagnosis Support Act. 

8 ‘‘(c) DATA COLLECTION.— 

9 ‘‘(1) PROVISION OF ASSISTANCE.—The Sec10 retary, acting through the Director of Centers for 

11 Disease Control and Prevention, shall provide assist12 ance to State and local health departments to inte13 grate the results of prenatal testing into State-based 

14 vital statistics and birth defects surveillance pro15 grams. 

16 ‘‘(2) ACTIVITIES.—The Secretary shall ensure 

17 that activities carried out under paragraph (1) are 

18 sufficient to extract population-level data relating to 

19 national rates and results of prenatal testing. 

20 ‘‘(d) PROVISION OF INFORMATION BY PROVIDERS.— 

21 Upon receipt of a positive test result from a prenatal test 

22 for Down syndrome or other prenatally diagnosed condi23 tions performed on a patient, the health care provider in24 volved (or his or her designee) shall provide the patient 

25 with the following: 
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1 ‘‘(1) Up-to-date, scientific, written information 

2 concerning the life expectancy, clinical course, and 

3 intellectual and functional development and treat4 ment options for a fetus diagnosed with or child 

5 born with Down syndrome or other prenatally diag6 nosed conditions. 

7 ‘‘(2) Referral to supportive services providers, 

8 including information hotlines specific to Down syn9 drome or other prenatally diagnosed conditions, re10 source centers or clearinghouses, and other edu11 cation and support programs as described in sub12 section (b)(2). 

13 ‘‘(e) PRIVACY.— 

14 ‘‘(1) IN GENERAL.—Notwithstanding sub15 sections (c) and (d), nothing in this section shall be 

16 construed to permit or require the collection, mainte17 nance, or transmission, without the health care pro18 vider obtaining the prior, written consent of the pa19 tient, of— 

20 ‘‘(A) health information or data that iden21 tify a patient, or with respect to which there is 

22 a reasonable basis to believe the information 

23 could be used to identify the patient (including 

24 a patient’s name, address, healthcare provider, 

25 or hospital); and 
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1 ‘‘(B) data that are not related to the epi2 demiology of the condition being tested for. 

3 ‘‘(2) GUIDANCE.—Not later than 180 days 

4 after the date of enactment of this section, the Sec5 retary shall establish guidelines concerning the im6 plementation of paragraph (1) and subsection (d). 

7 ‘‘(f) REPORTS.— 

8 ‘‘(1) IMPLEMENTATION REPORT.—Not later 

9 than 2 years after the date of enactment of this sec10 tion, and every 2 years thereafter, the Secretary 

11 shall submit a report to Congress concerning the im12 plementation of the guidelines described in sub13 section (e)(2). 

14 ‘‘(2) GAO REPORT.—Not later than 1 year 

15 after the date of enactment of this section, the Gov16 ernment Accountability Office shall submit a report 

17 to Congress concerning the effectiveness of current 

18 healthcare and family support programs serving as 

19 resources for the families of children with disabil20 ities. 

21 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

22 is authorized to be appropriated to carry out this section, 

23 $5,000,000 for each of fiscal years 2006 through 2010.’’. 

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