II 

110TH CONGRESS 

1ST SESSION S. 1810 

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 and 

postnatally diagnosed conditions. 

IN THE SENATE OF THE UNITED STATES 

JULY 18 (legislative day, JULY 17), 2007 

Mr. BROWNBACK introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

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 and postnatally 

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 and 

5 Postnatally Diagnosed Conditions 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 or postnatally diagnosed conditions, as 

25 well as to provide up-to-date, comprehensive infor26 mation about life expectancy, development potential, 


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1 and quality of life for a child born with Down syn2 drome or other prenatally or postnatally diagnosed 

3 condition; 

4 (2) strengthen existing networks of support 

5 through a Centers for Disease Control and Preven6 tion patient and provider outreach program; 

7 (3) improve available data by incorporating in8 formation directly revealed by prenatal or postnatal 

9 testing into existing State-based surveillance pro10 grams for birth defects and prenatally or postnatally 

11 diagnosed conditions; and 

12 (4) ensure that patients receive up-to-date, sci13 entific information about the accuracy of the test. 

14 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

15 ACT. 

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

17 (42 U.S.C. 280g et seq.) is amended by adding at the end 

18 the following: 

19 ‘‘SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSI20 TIVE TEST DIAGNOSIS OF DOWN SYNDROME 

21 OR OTHER PRENATALLY OR POSTNATALLY 

22 DIAGNOSED CONDITIONS. 

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

24 ‘‘(1) DOWN SYNDROME.—The term ‘Down syn25 drome’ refers to a chromosomal disorder caused by 


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1 an error in cell division that results in the presence 

2 of an extra whole or partial copy of chromosome 21. 

3 ‘‘(2) HEALTH CARE PROVIDER.—The term 

4 ‘health care provider’ means any person or entity re5 quired by State or Federal law or regulation to be 

6 licensed, registered, or certified to provide health 

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

8 certified. 

9 ‘‘(3) POSTNATALLY DIAGNOSED CONDITION.— 

10 The term ‘postnatally diagnosed condition’ means 

11 any health condition identified by postnatal genetic 

12 testing or postnatal screening procedures during the 

13 12-month period beginning at birth. 

14 ‘‘(4) PRENATALLY DIAGNOSED CONDITION.— 

15 The term ‘prenatally diagnosed condition’ means any 

16 fetal health condition identified by prenatal genetic 

17 testing or prenatal screening procedures. 

18 ‘‘(5) POSTNATAL TEST.—The term ‘postnatal 

19 test’ means diagnostic or screening tests offered with 

20 respect to an individual from birth to 1 year of age 

21 that is administered on a required or recommended 

22 basis by a health care provider based on medical his23 tory, family background, ethnic background, pre24 vious test results, symptoms the child is presenting, 

25 or other risk factors. 


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1 ‘‘(6) PRENATAL TEST.—The term ‘prenatal 

2 test’ means diagnostic or screening tests offered to 

3 pregnant women seeking routine prenatal care that 

4 are administered on a required or recommended 

5 basis by a health care provider based on medical his6 tory, family background, ethnic background, pre7 vious test results, or other risk factors. 

8 ‘‘(b) INFORMATION AND SUPPORT SERVICES.— 

9 ‘‘(1) IN GENERAL.—The Secretary, acting 

10 through the Director of the National Institutes of 

11 Health, the Director of the Centers for Disease Con12 trol and Prevention, or the Administrator of the 

13 Health Resources and Services Administration, may 

14 authorize and oversee certain activities, including the 

15 awarding of grants, contracts or cooperative agree16 ments, to— 

17 ‘‘(A) collect, synthesize, and disseminate 

18 current scientific information relating to Down 

19 syndrome or other prenatally or postnatally di20 agnosed conditions; and 

21 ‘‘(B) coordinate the provision of, and ac22 cess to, new or existing supportive services for 

23 patients receiving a positive test diagnosis for 

24 Down syndrome or other prenatally or 

25 postnatally diagnosed conditions, including— 


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1 ‘‘(i) the establishment of a resource 

2 telephone hotline and Internet website ac3 cessible to patients receiving a positive test 

4 result; 

5 ‘‘(ii) the expansion and further devel6 opment of the National Dissemination 

7 Center for Children with Disabilities, so 

8 that such Center can more effectively con9 duct outreach to new and expecting par10 ents and provide them with up-to-date in11 formation on the clinical course, life ex12 pectancy, development potential, quality of 

13 life, and available resources and services 

14 for children with Down syndrome or other 

15 prenatally and postnatally diagnosed condi16 tions; 

17 ‘‘(iii) the expansion and further devel18 opment of national and local peer-support 

19 programs, so that such programs can more 

20 effectively serve parents of newly diagnosed 

21 children; 

22 ‘‘(iv) the establishment of a national 

23 registry, or network of local registries, of 

24 families willing to adopt newborns with 

25 Down syndrome or other prenatally or 


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1 postnatally diagnosed conditions, and links 

2 to adoption agencies willing to place babies 

3 with Down syndrome or other prenatally or 

4 postnatally diagnosed conditions, with fam5 ilies willing to adopt; and 

6 ‘‘(v) the establishment of awareness 

7 and education programs for health care 

8 providers who provide the results of pre9 natal or postnatal tests for Down syn10 drome or other prenatally or postnatally 

11 diagnosed conditions, to patients, con12 sistent with the purpose described in sec13 tion 2(b)(1) of the Prenatally and 

14 Postnatally Diagnosed Conditions Aware15 ness Act. 

16 ‘‘(2) DISTRIBUTION.—In distributing funds 

17 under this subsection, the Secretary shall place an 

18 emphasis on funding partnerships between health 

19 care groups and disability advocacy organizations. 

20 ‘‘(c) DATA COLLECTION.— 

21 ‘‘(1) PROVISION OF ASSISTANCE.—The Sec22 retary, acting through the Director of Centers for 

23 Disease Control and Prevention, shall provide assist24 ance to State and local health departments to inte25 grate the results of prenatal or postnatal testing into 


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1 State-based vital statistics and birth defects surveil2 lance programs. 

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

4 that activities carried out under paragraph (1) are 

5 sufficient to extract population-level data relating to 

6 national rates and results of prenatal or postnatal 

7 testing. 

8 ‘‘(3) INFORMED CONSENT.—Prior to the report9 ing of the results of a prenatal or postnatal test to 

10 a State or local public health department under this 

11 subsection, the patient involved shall be provided 

12 with a disclosure statement that describes the man13 ner in which the results of such tests will be used. 

14 Such results may not be reported unless the patient 

15 consents to such reporting after receipt of such dis16 closure statement. 

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

18 Upon receipt of a positive test result from a prenatal or 

19 postnatal test for Down syndrome or other prenatally or 

20 postnatally diagnosed conditions performed on a patient, 

21 the health care provider involved (or his or her designee) 

22 shall provide the patient with the following: 

23 ‘‘(1) Up-to-date, scientific, written information 

24 concerning the life expectancy, clinical course, and 

25 intellectual and functional development and treatVerDate Aug 31 2005 07:58 Jul 20, 2007 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1810.IS S1810

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1 ment options for a fetus diagnosed with or child 

2 born with Down syndrome or other prenatally or 

3 postnatally diagnosed conditions. 

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

5 including information hotlines specific to Down syn6 drome or other prenatally or postnatally diagnosed 

7 conditions, resource centers or clearinghouses, and 

8 other education and support programs as described 

9 in subsection (b)(2). 

10 ‘‘(e) PRIVACY.— 

11 ‘‘(1) IN GENERAL.—Notwithstanding sub12 sections (c) and (d), nothing in this section shall be 

13 construed to permit or require the collection, mainte14 nance, or transmission, without the health care pro15 vider obtaining the prior, written consent of the pa16 tient, of— 

17 ‘‘(A) health information or data that iden18 tify a patient, or with respect to which there is 

19 a reasonable basis to believe the information 

20 could be used to identify the patient (including 

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

22 or hospital); and 

23 ‘‘(B) data that are not related to the epi24 demiology of the condition being tested for. 


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

2 after the date of enactment of this section, the Sec3 retary shall establish guidelines concerning the im4 plementation of paragraph (1) and subsection (d). 

5 ‘‘(f) REPORTS.— 

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

7 than 2 years after the date of enactment of this sec8 tion, and every 2 years thereafter, the Secretary 

9 shall submit a report to Congress concerning the im10 plementation of the guidelines described in sub11 section (e)(2). 

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

13 after the date of enactment of this section, the Gov14 ernment Accountability Office shall submit a report 

15 to Congress concerning the effectiveness of current 

16 healthcare and family support programs serving as 

17 resources for the families of children with disabil18 ities. 

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

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

21 $5,000,000 for each of fiscal years 2008 through 2012.’’. 

Æ 


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