II 

Calendar No. 701 

110TH CONGRESS 

2D 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 (for himself, Mr. KENNEDY, and Mr. DORGAN) introduced 

the following bill; which was read twice and referred to the Committee 

on Health, Education, Labor, and Pensions 

APRIL 21, 2008 

Reported by Mr. KENNEDY, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 

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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Prenatally and 

3 Postnatally Diagnosed Conditions Awareness Act’’. 

4 SEC. 2. FINDINGS AND PURPOSES. 

5 (a) FINDINGS.—Congress makes the following find6 ings: 

7 (1) Pregnant women who choose to undergo 

8 prenatal genetic testing should have access to timely, 

9 scientific, and nondirective counseling about the con10 ditions being tested for and the accuracy of such 

11 tests, from health care professionals qualified to pro12 vide and interpret these tests. Informed consent is a 

13 critical component of all genetic testing. 

14 (2) A recent, peer-reviewed study and two re15 ports from the Centers for Disease Control and Pre16 vention on prenatal testing found a deficiency in the 

17 data needed to understand the epidemiology of pre18 natally diagnosed conditions, to monitor trends accu19 rately, and to increase the effectiveness of health 

20 intervention. 

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

22 the diagnosis of a fetus with Down syndrome or other pre23 natally diagnosed conditions, to— 

24 (1) increase patient referrals to providers of key 

25 support services for women who have received a 

26 positive test diagnosis for Down syndrome, or other 

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1 prenatally or postnatally diagnosed conditions, as 

2 well as to provide up-to-date, comprehensive infor3 mation about life expectancy, development potential, 

4 and quality of life for a child born with Down syn5 drome or other prenatally or postnatally diagnosed 

6 condition; 

7 (2) strengthen existing networks of support 

8 through a Centers for Disease Control and Preven9 tion patient and provider outreach program; 

10 (3) improve available data by incorporating in11 formation directly revealed by prenatal or postnatal 

12 testing into existing State-based surveillance pro13 grams for birth defects and prenatally or postnatally 

14 diagnosed conditions; and 

15 (4) ensure that patients receive up-to-date, sci16 entific information about the accuracy of the test. 

17 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

18 ACT. 

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

20 (42 U.S.C. 280g et seq.) is amended by adding at the end 

21 the following: 

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1 ‘‘SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSI2 TIVE TEST DIAGNOSIS OF DOWN SYNDROME 

3 OR OTHER PRENATALLY OR POSTNATALLY 

4 DIAGNOSED CONDITIONS. 

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

6 ‘‘(1) DOWN SYNDROME.—The term ‘Down syn7 drome’ refers to a chromosomal disorder caused by 

8 an error in cell division that results in the presence 

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

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

11 ‘health care provider’ means any person or entity re12 quired by State or Federal law or regulation to be 

13 licensed, registered, or certified to provide health 

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

15 certified. 

16 ‘‘(3) POSTNATALLY DIAGNOSED CONDITION.— 

17 The term ‘postnatally diagnosed condition’ means 

18 any health condition identified by postnatal genetic 

19 testing or postnatal screening procedures during the 

20 12-month period beginning at birth. 

21 ‘‘(4) PRENATALLY DIAGNOSED CONDITION.— 

22 The term ‘prenatally diagnosed condition’ means any 

23 fetal health condition identified by prenatal genetic 

24 testing or prenatal screening procedures. 

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

26 test’ means diagnostic or screening tests offered with 

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

2 that is administered on a required or recommended 

3 basis by a health care provider based on medical his4 tory, family background, ethnic background, pre5 vious test results, symptoms the child is presenting, 

6 or other risk factors. 

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

8 test’ means diagnostic or screening tests offered to 

9 pregnant women seeking routine prenatal care that 

10 are administered on a required or recommended 

11 basis by a health care provider based on medical his12 tory, family background, ethnic background, pre13 vious test results, or other risk factors. 

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

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

16 through the Director of the National Institutes of 

17 Health, the Director of the Centers for Disease Con18 trol and Prevention, or the Administrator of the 

19 Health Resources and Services Administration, may 

20 authorize and oversee certain activities, including the 

21 awarding of grants, contracts or cooperative agree22 ments, to— 

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

24 current scientific information relating to Down 

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1 syndrome or other prenatally or postnatally di2 agnosed conditions; and 

3 ‘‘(B) coordinate the provision of, and ac4 cess to, new or existing supportive services for 

5 patients receiving a positive test diagnosis for 

6 Down syndrome or other prenatally or 

7 postnatally diagnosed conditions, including— 

8 ‘‘(i) the establishment of a resource 

9 telephone hotline and Internet website ac10 cessible to patients receiving a positive test 

11 result; 

12 ‘‘(ii) the expansion and further devel13 opment of the National Dissemination 

14 Center for Children with Disabilities, so 

15 that such Center can more effectively con16 duct outreach to new and expecting par17 ents and provide them with up-to-date in18 formation on the clinical course, life ex19 pectancy, development potential, quality of 

20 life, and available resources and services 

21 for children with Down syndrome or other 

22 prenatally and postnatally diagnosed condi23 tions; 

24 ‘‘(iii) the expansion and further devel25 opment of national and local peer-support 

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1 programs, so that such programs can more 

2 effectively serve parents of newly diagnosed 

3 children; 

4 ‘‘(iv) the establishment of a national 

5 registry, or network of local registries, of 

6 families willing to adopt newborns with 

7 Down syndrome or other prenatally or 

8 postnatally diagnosed conditions, and links 

9 to adoption agencies willing to place babies 

10 with Down syndrome or other prenatally or 

11 postnatally diagnosed conditions, with fam12 ilies willing to adopt; and 

13 ‘‘(v) the establishment of awareness 

14 and education programs for health care 

15 providers who provide the results of pre16 natal or postnatal tests for Down syn17 drome or other prenatally or postnatally 

18 diagnosed conditions, to patients, con19 sistent with the purpose described in sec20 tion 2(b)(1) of the Prenatally and 

21 Postnatally Diagnosed Conditions Aware22 ness Act. 

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

24 under this subsection, the Secretary shall place an 

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1 emphasis on funding partnerships between health 

2 care groups and disability advocacy organizations. 

3 ‘‘(c) DATA COLLECTION.— 

4 ‘‘(1) PROVISION OF ASSISTANCE.—The Sec5 retary, acting through the Director of Centers for 

6 Disease Control and Prevention, shall provide assist7 ance to State and local health departments to inte8 grate the results of prenatal or postnatal testing into 

9 State-based vital statistics and birth defects surveil10 lance programs. 

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

12 that activities carried out under paragraph (1) are 

13 sufficient to extract population-level data relating to 

14 national rates and results of prenatal or postnatal 

15 testing. 

16 ‘‘(3) INFORMED CONSENT.—Prior to the report17 ing of the results of a prenatal or postnatal test to 

18 a State or local public health department under this 

19 subsection, the patient involved shall be provided 

20 with a disclosure statement that describes the man21 ner in which the results of such tests will be used. 

22 Such results may not be reported unless the patient 

23 consents to such reporting after receipt of such dis24 closure statement. 

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

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

3 postnatal test for Down syndrome or other prenatally or 

4 postnatally diagnosed conditions performed on a patient, 

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

6 shall provide the patient with the following: 

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

8 concerning the life expectancy, clinical course, and 

9 intellectual and functional development and treat10 ment options for a fetus diagnosed with or child 

11 born with Down syndrome or other prenatally or 

12 postnatally diagnosed conditions. 

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

14 including information hotlines specific to Down syn15 drome or other prenatally or postnatally diagnosed 

16 conditions, resource centers or clearinghouses, and 

17 other education and support programs as described 

18 in subsection (b)(2). 

19 ‘‘(e) PRIVACY.— 

20 ‘‘(1) IN GENERAL.—Notwithstanding sub21 sections (c) and (d), nothing in this section shall be 

22 construed to permit or require the collection, mainte23 nance, or transmission, without the health care pro24 vider obtaining the prior, written consent of the pa25 tient, of— 

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1 ‘‘(A) health information or data that iden2 tify a patient, or with respect to which there is 

3 a reasonable basis to believe the information 

4 could be used to identify the patient (including 

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

6 or hospital); and 

7 ‘‘(B) data that are not related to the epi8 demiology of the condition being tested for. 

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

10 after the date of enactment of this section, the Sec11 retary shall establish guidelines concerning the im12 plementation of paragraph (1) and subsection (d). 

13 ‘‘(f) REPORTS.— 

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

15 than 2 years after the date of enactment of this sec16 tion, and every 2 years thereafter, the Secretary 

17 shall submit a report to Congress concerning the im18 plementation of the guidelines described in sub19 section (e)(2). 

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

21 after the date of enactment of this section, the Gov22 ernment Accountability Office shall submit a report 

23 to Congress concerning the effectiveness of current 

24 healthcare and family support programs serving as 

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1 resources for the families of children with disabil2 ities. 

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

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

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

6 SECTION 1. SHORT TITLE. 

7 This Act may be cited as the ‘‘Prenatally and 

8 Postnatally Diagnosed Conditions Awareness Act’’. 

9 SEC. 2. PURPOSES. 

10 It is the purpose of this Act to— 

11 (1) increase patient referrals to providers of key 

12 support services for women who have received a posi13 tive diagnosis for Down syndrome, or other pre14 natally or postnatally diagnosed conditions, as well 

15 as to provide up-to-date information on the range of 

16 outcomes for individuals living with the diagnosed 

17 condition, including physical, developmental, edu18 cational, and psychosocial outcomes; 

19 (2) strengthen existing networks of support 

20 through the Centers for Disease Control and Preven21 tion, the Health Resources and Services Administra22 tion, and other patient and provider outreach pro23 grams; and 

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1 (3) ensure that patients receive up-to-date, evi2 dence-based information about the accuracy of the 

3 test. 

4 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT. 

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

6 (42 U.S.C. 280g et seq.) is amended by adding at the end 

7 the following: 

8 ‘‘SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSI9 TIVE DIAGNOSIS OF DOWN SYNDROME OR 

10 OTHER PRENATALLY OR POSTNATALLY DIAG11 NOSED CONDITIONS. 

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

13 ‘‘(1) DOWN SYNDROME.—The term ‘Down syn14 drome’ refers to a chromosomal disorder caused by an 

15 error in cell division that results in the presence of 

16 an extra whole or partial copy of chromosome 21. 

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

18 ‘health care provider’ means any person or entity re19 quired by State or Federal law or regulation to be li20 censed, registered, or certified to provide health care 

21 services, and who is so licensed, registered, or cer22 tified. 

23 ‘‘(3) POSTNATALLY DIAGNOSED CONDITION.—The 

24 term ‘postnatally diagnosed condition’ means any 

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1 health condition identified during the 12-month pe2 riod beginning at birth. 

3 ‘‘(4) PRENATALLY DIAGNOSED CONDITION.—The 

4 term ‘prenatally diagnosed condition’ means any fetal 

5 health condition identified by prenatal genetic testing 

6 or prenatal screening procedures. 

7 ‘‘(5) PRENATAL TEST.—The term ‘prenatal test’ 

8 means diagnostic or screening tests offered to preg9 nant women seeking routine prenatal care that are 

10 administered on a required or recommended basis by 

11 a health care provider based on medical history, fam12 ily background, ethnic background, previous test re13 sults, or other risk factors. 

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

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

16 through the Director of the National Institutes of 

17 Health, the Director of the Centers for Disease Control 

18 and Prevention, or the Administrator of the Health 

19 Resources and Services Administration, may author20 ize and oversee certain activities, including the 

21 awarding of grants, contracts or cooperative agree22 ments to eligible entities, to— 

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

24 current evidence-based information relating to 

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1 Down syndrome or other prenatally or 

2 postnatally diagnosed conditions; and 

3 ‘‘(B) coordinate the provision of, and access 

4 to, new or existing supportive services for pa5 tients receiving a positive diagnosis for Down 

6 syndrome or other prenatally or postnatally di7 agnosed conditions, including— 

8 ‘‘(i) the establishment of a resource 

9 telephone hotline accessible to patients re10 ceiving a positive test result or to the par11 ents of newly diagnosed infants with Down 

12 syndrome and other diagnosed conditions; 

13 ‘‘(ii) the expansion and further devel14 opment of the National Dissemination Cen15 ter for Children with Disabilities, so that 

16 such Center can more effectively conduct 

17 outreach to new and expecting parents and 

18 provide them with up-to-date information 

19 on the range of outcomes for individuals liv20 ing with the diagnosed condition, including 

21 physical, developmental, educational, and 

22 psychosocial outcomes; 

23 ‘‘(iii) the expansion and further devel24 opment of national and local peer-support 

25 programs, so that such programs can more 

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1 effectively serve women who receive a posi2 tive diagnosis for Down syndrome or other 

3 prenatal conditions or parents of infants 

4 with a postnatally diagnosed condition; 

5 ‘‘(iv) the establishment of a national 

6 registry, or network of local registries, of 

7 families willing to adopt newborns with 

8 Down syndrome or other prenatally or 

9 postnatally diagnosed conditions, and links 

10 to adoption agencies willing to place babies 

11 with Down syndrome or other prenatally or 

12 postnatally diagnosed conditions, with fam13 ilies willing to adopt; and 

14 ‘‘(v) the establishment of awareness 

15 and education programs for health care pro16 viders who provide, interpret, or inform 

17 parents of the results of prenatal tests for 

18 Down syndrome or other prenatally or 

19 postnatally diagnosed conditions, to pa20 tients, consistent with the purpose described 

21 in section 2(b)(1) of the Prenatally and 

22 Postnatally Diagnosed Conditions Aware23 ness Act. 

24 ‘‘(2) ELIGIBLE ENTITY.—In this subsection, the 

25 term ‘eligible entity’ means— 

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1 ‘‘(A) a State or a political subdivision of a 

2 State; 

3 ‘‘(B) a consortium of 2 or more States or 

4 political subdivisions of States; 

5 ‘‘(C) a territory; 

6 ‘‘(D) a health facility or program operated 

7 by or pursuant to a contract with or grant from 

8 the Indian Health Service; or 

9 ‘‘(E) any other entity with appropriate ex10 pertise in prenatally and postnatally diagnosed 

11 conditions (including nationally recognized dis12 ability groups), as determined by the Secretary. 

13 ‘‘(3) DISTRIBUTION.—In distributing funds 

14 under this subsection, the Secretary shall place an 

15 emphasis on funding partnerships between health care 

16 professional groups and disability advocacy organiza17 tions. 

18 ‘‘(c) PROVISION OF INFORMATION TO PROVIDERS.— 

19 ‘‘(1) IN GENERAL.—A grantee under this section 

20 shall make available to health care providers of par21 ents who receive a prenatal or postnatal diagnosis the 

22 following: 

23 ‘‘(A) Up-to-date, evidence-based, written in24 formation concerning the range of outcomes for 

25 individuals living with the diagnosed condition, 

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1 including physical, developmental, educational, 

2 and psychosocial outcomes. 

3 ‘‘(B) Contact information regarding sup4 port services, including information hotlines spe5 cific to Down syndrome or other prenatally or 

6 postnatally diagnosed conditions, resource cen7 ters or clearinghouses, national and local peer 

8 support groups, and other education and support 

9 programs as described in subsection (b)(2). 

10 ‘‘(2) INFORMATIONAL REQUIREMENTS.—Informa11 tion provided under this subsection shall be— 

12 ‘‘(A) culturally and linguistically appro13 priate as needed by women receiving a positive 

14 prenatal diagnosis or the family of infants re15 ceiving a postnatal diagnosis; and 

16 ‘‘(B) approved by the Secretary. 

17 ‘‘(d) REPORT.—Not later than 2 years after the date 

18 of enactment of this section, the Government Accountability 

19 Office shall submit a report to Congress concerning the effec20 tiveness of current healthcare and family support programs 

21 serving as resources for the families of children with disabil22 ities. 

23 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is 

24 authorized to be appropriated to carry out this section, 

25 $5,000,000 for each of fiscal years 2008 through 2012.’’. 

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Calendar No. 701 

110TH CONGRESS 

2D SESSION S. 1810 

A BILL 

To amend the Public Health Service Act to increase 

prenatally and postnatally diagnosed conditions. tive test diagnosis for Down syndrome or other and support services to patients receiving a posithe provision of scientifically sound information 

APRIL 21, 2008 

Reported with an amendment 

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