[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1810 Reported in Senate (RS)]






                                                       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.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Prenatally and Postnatally 
Diagnosed Conditions Awareness Act''.</DELETED>

<DELETED>SEC. 2. FINDINGS AND PURPOSES.</DELETED>

<DELETED>    (a) Findings.--Congress makes the following 
findings:</DELETED>
        <DELETED>    (1) Pregnant women who choose to undergo prenatal 
        genetic testing should have access to timely, scientific, and 
        nondirective counseling about the conditions being tested for 
        and the accuracy of such tests, from health care professionals 
        qualified to provide and interpret these tests. Informed 
        consent is a critical component of all genetic 
        testing.</DELETED>
        <DELETED>    (2) A recent, peer-reviewed study and two reports 
        from the Centers for Disease Control and Prevention on prenatal 
        testing found a deficiency in the data needed to understand the 
        epidemiology of prenatally diagnosed conditions, to monitor 
        trends accurately, and to increase the effectiveness of health 
        intervention.</DELETED>
<DELETED>    (b) Purposes.--It is the purpose of this Act, after the 
diagnosis of a fetus with Down syndrome or other prenatally diagnosed 
conditions, to--</DELETED>
        <DELETED>    (1) increase patient referrals to providers of key 
        support services for women who have received a positive test 
        diagnosis for Down syndrome, or other prenatally or postnatally 
        diagnosed conditions, as well as to provide up-to-date, 
        comprehensive information about life expectancy, development 
        potential, and quality of life for a child born with Down 
        syndrome or other prenatally or postnatally diagnosed 
        condition;</DELETED>
        <DELETED>    (2) strengthen existing networks of support 
        through a Centers for Disease Control and Prevention patient 
        and provider outreach program;</DELETED>
        <DELETED>    (3) improve available data by incorporating 
        information directly revealed by prenatal or postnatal testing 
        into existing State-based surveillance programs for birth 
        defects and prenatally or postnatally diagnosed conditions; 
        and</DELETED>
        <DELETED>    (4) ensure that patients receive up-to-date, 
        scientific information about the accuracy of the 
        test.</DELETED>

<DELETED>SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.</DELETED>

<DELETED>    Part P of title III of the Public Health Service Act (42 
U.S.C. 280g et seq.) is amended by adding at the end the 
following:</DELETED>

<DELETED>``SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSITIVE TEST 
              DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY OR 
              POSTNATALLY DIAGNOSED CONDITIONS.</DELETED>

<DELETED>    ``(a) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Down syndrome.--The term `Down syndrome' 
        refers to a chromosomal disorder caused by an error in cell 
        division that results in the presence of an extra whole or 
        partial copy of chromosome 21.</DELETED>
        <DELETED>    ``(2) Health care provider.--The term `health care 
        provider' means any person or entity required by State or 
        Federal law or regulation to be licensed, registered, or 
        certified to provide health care services, and who is so 
        licensed, registered, or certified.</DELETED>
        <DELETED>    ``(3) Postnatally diagnosed condition.--The term 
        `postnatally diagnosed condition' means any health condition 
        identified by postnatal genetic testing or postnatal screening 
        procedures during the 12-month period beginning at 
        birth.</DELETED>
        <DELETED>    ``(4) Prenatally diagnosed condition.--The term 
        `prenatally diagnosed condition' means any fetal health 
        condition identified by prenatal genetic testing or prenatal 
        screening procedures.</DELETED>
        <DELETED>    ``(5) Postnatal test.--The term `postnatal test' 
        means diagnostic or screening tests offered with respect to an 
        individual from birth to 1 year of age that is administered on 
        a required or recommended basis by a health care provider based 
        on medical history, family background, ethnic background, 
        previous test results, symptoms the child is presenting, or 
        other risk factors.</DELETED>
        <DELETED>    ``(6) Prenatal test.--The term `prenatal test' 
        means diagnostic or screening tests offered to pregnant women 
        seeking routine prenatal care that are administered on a 
        required or recommended basis by a health care provider based 
        on medical history, family background, ethnic background, 
        previous test results, or other risk factors.</DELETED>
<DELETED>    ``(b) Information and Support Services.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, acting through 
        the Director of the National Institutes of Health, the Director 
        of the Centers for Disease Control and Prevention, or the 
        Administrator of the Health Resources and Services 
        Administration, may authorize and oversee certain activities, 
        including the awarding of grants, contracts or cooperative 
        agreements, to--</DELETED>
                <DELETED>    ``(A) collect, synthesize, and disseminate 
                current scientific information relating to Down 
                syndrome or other prenatally or postnatally diagnosed 
                conditions; and</DELETED>
                <DELETED>    ``(B) coordinate the provision of, and 
                access to, new or existing supportive services for 
                patients receiving a positive test diagnosis for Down 
                syndrome or other prenatally or postnatally diagnosed 
                conditions, including--</DELETED>
                        <DELETED>    ``(i) the establishment of a 
                        resource telephone hotline and Internet website 
                        accessible to patients receiving a positive 
                        test result;</DELETED>
                        <DELETED>    ``(ii) the expansion and further 
                        development of the National Dissemination 
                        Center for Children with Disabilities, so that 
                        such Center can more effectively conduct 
                        outreach to new and expecting parents and 
                        provide them with up-to-date information on the 
                        clinical course, life expectancy, development 
                        potential, quality of life, and available 
                        resources and services for children with Down 
                        syndrome or other prenatally and postnatally 
                        diagnosed conditions;</DELETED>
                        <DELETED>    ``(iii) the expansion and further 
                        development of national and local peer-support 
                        programs, so that such programs can more 
                        effectively serve parents of newly diagnosed 
                        children;</DELETED>
                        <DELETED>    ``(iv) the establishment of a 
                        national registry, or network of local 
                        registries, of families willing to adopt 
                        newborns with Down syndrome or other prenatally 
                        or postnatally diagnosed conditions, and links 
                        to adoption agencies willing to place babies 
                        with Down syndrome or other prenatally or 
                        postnatally diagnosed conditions, with families 
                        willing to adopt; and</DELETED>
                        <DELETED>    ``(v) the establishment of 
                        awareness and education programs for health 
                        care providers who provide the results of 
                        prenatal or postnatal tests for Down syndrome 
                        or other prenatally or postnatally diagnosed 
                        conditions, to patients, consistent with the 
                        purpose described in section 2(b)(1) of the 
                        Prenatally and Postnatally Diagnosed Conditions 
                        Awareness Act.</DELETED>
        <DELETED>    ``(2) Distribution.--In distributing funds under 
        this subsection, the Secretary shall place an emphasis on 
        funding partnerships between health care groups and disability 
        advocacy organizations.</DELETED>
<DELETED>    ``(c) Data Collection.--</DELETED>
        <DELETED>    ``(1) Provision of assistance.--The Secretary, 
        acting through the Director of Centers for Disease Control and 
        Prevention, shall provide assistance to State and local health 
        departments to integrate the results of prenatal or postnatal 
        testing into State-based vital statistics and birth defects 
        surveillance programs.</DELETED>
        <DELETED>    ``(2) Activities.--The Secretary shall ensure that 
        activities carried out under paragraph (1) are sufficient to 
        extract population-level data relating to national rates and 
        results of prenatal or postnatal testing.</DELETED>
        <DELETED>    ``(3) Informed consent.--Prior to the reporting of 
        the results of a prenatal or postnatal test to a State or local 
        public health department under this subsection, the patient 
        involved shall be provided with a disclosure statement that 
        describes the manner in which the results of such tests will be 
        used. Such results may not be reported unless the patient 
        consents to such reporting after receipt of such disclosure 
        statement.</DELETED>
<DELETED>    ``(d) Provision of Information by Providers.--Upon receipt 
of a positive test result from a prenatal or postnatal test for Down 
syndrome or other prenatally or postnatally diagnosed conditions 
performed on a patient, the health care provider involved (or his or 
her designee) shall provide the patient with the following:</DELETED>
        <DELETED>    ``(1) Up-to-date, scientific, written information 
        concerning the life expectancy, clinical course, and 
        intellectual and functional development and treatment options 
        for a fetus diagnosed with or child born with Down syndrome or 
        other prenatally or postnatally diagnosed conditions.</DELETED>
        <DELETED>    ``(2) Referral to supportive services providers, 
        including information hotlines specific to Down syndrome or 
        other prenatally or postnatally diagnosed conditions, resource 
        centers or clearinghouses, and other education and support 
        programs as described in subsection (b)(2).</DELETED>
<DELETED>    ``(e) Privacy.--</DELETED>
        <DELETED>    ``(1) In general.--Notwithstanding subsections (c) 
        and (d), nothing in this section shall be construed to permit 
        or require the collection, maintenance, or transmission, 
        without the health care provider obtaining the prior, written 
        consent of the patient, of--</DELETED>
                <DELETED>    ``(A) health information or data that 
                identify a patient, or with respect to which there is a 
                reasonable basis to believe the information could be 
                used to identify the patient (including a patient's 
                name, address, healthcare provider, or hospital); 
                and</DELETED>
                <DELETED>    ``(B) data that are not related to the 
                epidemiology of the condition being tested 
                for.</DELETED>
        <DELETED>    ``(2) Guidance.--Not later than 180 days after the 
        date of enactment of this section, the Secretary shall 
        establish guidelines concerning the implementation of paragraph 
        (1) and subsection (d).</DELETED>
<DELETED>    ``(f) Reports.--</DELETED>
        <DELETED>    ``(1) Implementation report.--Not later than 2 
        years after the date of enactment of this section, and every 2 
        years thereafter, the Secretary shall submit a report to 
        Congress concerning the implementation of the guidelines 
        described in subsection (e)(2).</DELETED>
        <DELETED>    ``(2) GAO report.--Not later than 1 year after the 
        date of enactment of this section, the Government 
        Accountability Office shall submit a report to Congress 
        concerning the effectiveness of current healthcare and family 
        support programs serving as resources for the families of 
        children with disabilities.</DELETED>
<DELETED>    ``(g) Authorization of Appropriations.--There is 
authorized to be appropriated to carry out this section, $5,000,000 for 
each of fiscal years 2008 through 2012.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prenatally and Postnatally Diagnosed 
Conditions Awareness Act''.

SEC. 2. PURPOSES.

    It is the purpose of this Act to--
            (1) increase patient referrals to providers of key support 
        services for women who have received a positive diagnosis for 
        Down syndrome, or other prenatally or postnatally diagnosed 
        conditions, as well as to provide up-to-date information on the 
        range of outcomes for individuals living with the diagnosed 
        condition, including physical, developmental, educational, and 
        psychosocial outcomes;
            (2) strengthen existing networks of support through the 
        Centers for Disease Control and Prevention, the Health 
        Resources and Services Administration, and other patient and 
        provider outreach programs; and
            (3) ensure that patients receive up-to-date, evidence-based 
        information about the accuracy of the test.

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

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399R. SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS OF 
              DOWN SYNDROME OR OTHER PRENATALLY OR POSTNATALLY 
              DIAGNOSED CONDITIONS.

    ``(a) Definitions.--In this section:
            ``(1) Down syndrome.--The term `Down syndrome' refers to a 
        chromosomal disorder caused by an error in cell division that 
        results in the presence of an extra whole or partial copy of 
        chromosome 21.
            ``(2) Health care provider.--The term `health care 
        provider' means any person or entity required by State or 
        Federal law or regulation to be licensed, registered, or 
        certified to provide health care services, and who is so 
        licensed, registered, or certified.
            ``(3) Postnatally diagnosed condition.--The term 
        `postnatally diagnosed condition' means any health condition 
        identified during the 12-month period beginning at birth.
            ``(4) Prenatally diagnosed condition.--The term `prenatally 
        diagnosed condition' means any fetal health condition 
        identified by prenatal genetic testing or prenatal screening 
        procedures.
            ``(5) Prenatal test.--The term `prenatal test' means 
        diagnostic or screening tests offered to pregnant women seeking 
        routine prenatal care that are administered on a required or 
        recommended basis by a health care provider based on medical 
        history, family background, ethnic background, previous test 
        results, or other risk factors.
    ``(b) Information and Support Services.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the National Institutes of Health, the Director of 
        the Centers for Disease Control and Prevention, or the 
        Administrator of the Health Resources and Services 
        Administration, may authorize and oversee certain activities, 
        including the awarding of grants, contracts or cooperative 
        agreements to eligible entities, to--
                    ``(A) collect, synthesize, and disseminate current 
                evidence-based information relating to Down syndrome or 
                other prenatally or postnatally diagnosed conditions; 
                and
                    ``(B) coordinate the provision of, and access to, 
                new or existing supportive services for patients 
                receiving a positive diagnosis for Down syndrome or 
                other prenatally or postnatally diagnosed conditions, 
                including--
                            ``(i) the establishment of a resource 
                        telephone hotline accessible to patients 
                        receiving a positive test result or to the 
                        parents of newly diagnosed infants with Down 
                        syndrome and other diagnosed conditions;
                            ``(ii) the expansion and further 
                        development of the National Dissemination 
                        Center for Children with Disabilities, so that 
                        such Center can more effectively conduct 
                        outreach to new and expecting parents and 
                        provide them with up-to-date information on the 
                        range of outcomes for individuals living with 
                        the diagnosed condition, including physical, 
                        developmental, educational, and psychosocial 
                        outcomes;
                            ``(iii) the expansion and further 
                        development of national and local peer-support 
                        programs, so that such programs can more 
                        effectively serve women who receive a positive 
                        diagnosis for Down syndrome or other prenatal 
                        conditions or parents of infants with a 
                        postnatally diagnosed condition;
                            ``(iv) the establishment of a national 
                        registry, or network of local registries, of 
                        families willing to adopt newborns with Down 
                        syndrome or other prenatally or postnatally 
                        diagnosed conditions, and links to adoption 
                        agencies willing to place babies with Down 
                        syndrome or other prenatally or postnatally 
                        diagnosed conditions, with families willing to 
                        adopt; and
                            ``(v) the establishment of awareness and 
                        education programs for health care providers 
                        who provide, interpret, or inform parents of 
                        the results of prenatal tests for Down syndrome 
                        or other prenatally or postnatally diagnosed 
                        conditions, to patients, consistent with the 
                        purpose described in section 2(b)(1) of the 
                        Prenatally and Postnatally Diagnosed Conditions 
                        Awareness Act.
            ``(2) Eligible entity.--In this subsection, the term 
        `eligible entity' means--
                    ``(A) a State or a political subdivision of a 
                State;
                    ``(B) a consortium of 2 or more States or political 
                subdivisions of States;
                    ``(C) a territory;
                    ``(D) a health facility or program operated by or 
                pursuant to a contract with or grant from the Indian 
                Health Service; or
                    ``(E) any other entity with appropriate expertise 
                in prenatally and postnatally diagnosed conditions 
                (including nationally recognized disability groups), as 
                determined by the Secretary.
            ``(3) Distribution.--In distributing funds under this 
        subsection, the Secretary shall place an emphasis on funding 
        partnerships between health care professional groups and 
        disability advocacy organizations.
    ``(c) Provision of Information to Providers.--
            ``(1) In general.--A grantee under this section shall make 
        available to health care providers of parents who receive a 
        prenatal or postnatal diagnosis the following:
                    ``(A) Up-to-date, evidence-based, written 
                information concerning the range of outcomes for 
                individuals living with the diagnosed condition, 
                including physical, developmental, educational, and 
                psychosocial outcomes.
                    ``(B) Contact information regarding support 
                services, including information hotlines specific to 
                Down syndrome or other prenatally or postnatally 
                diagnosed conditions, resource centers or 
                clearinghouses, national and local peer support groups, 
                and other education and support programs as described 
                in subsection (b)(2).
            ``(2) Informational requirements.--Information provided 
        under this subsection shall be--
                    ``(A) culturally and linguistically appropriate as 
                needed by women receiving a positive prenatal diagnosis 
                or the family of infants receiving a postnatal 
                diagnosis; and
                    ``(B) approved by the Secretary.
    ``(d) Report.--Not later than 2 years after the date of enactment 
of this section, the Government Accountability Office shall submit a 
report to Congress concerning the effectiveness of current healthcare 
and family support programs serving as resources for the families of 
children with disabilities.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $5,000,000 for each of fiscal 
years 2008 through 2012.''.
                                                       Calendar No. 701

110th CONGRESS

  2d Session

                                S. 1810

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             April 21, 2008

                       Reported with an amendment