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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1353 Introduced in House (IH)]

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prenatally Diagnosed Condition 
Awareness Act''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress makes the following findings:
            (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.
            (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.
    (b) Purposes.--It is the purpose of this Act, after the diagnosis 
of a fetus with Down syndrome or other prenatally diagnosed conditions, 
to--
            (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 diagnosed conditions, as 
        well as to provide up-to-date, science-based information about 
        life-expectancy, development potential, and quality of life for 
        a child born with Down syndrome or other prenatally diagnosed 
        condition;
            (2) provide networks of support through a Centers for 
        Disease Control and Prevention patient and provider outreach 
        program;
            (3) improve available data by incorporating information 
        directly revealed by prenatal testing into existing State-based 
        surveillance programs for birth defects and prenatally 
        diagnosed conditions; and
            (4) ensure that patients receive up-to-date, scientific 
        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. 399O. SUPPORT FOR PATIENTS RECEIVING A POSITIVE TEST DIAGNOSIS 
              OF DOWN SYNDROME OR OTHER PRENATALLY 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) Prenatally diagnosed condition.--The term `prenatally 
        diagnosed condition' means any fetal health condition 
        identified by prenatal genetic testing or prenatal screening 
        procedures.
            ``(4) 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.--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--
            ``(1) collect, synthesize, and disseminate current 
        scientific information relating to Down syndrome or other 
        prenatally diagnosed conditions; and
            ``(2) 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 diagnosed 
        conditions, including--
                    ``(A) the establishment of a resource telephone 
                hotline and Internet website accessible to patients 
                receiving a positive test result;
                    ``(B) the establishment of a clearinghouse of 
                scientific information, clinical course, life 
                expectancy, development potential, and quality of life 
                relating to Down syndrome or other prenatally diagnosed 
                conditions;
                    ``(C) the establishment of national and local peer-
                support programs;
                    ``(D) the establishment of a national registry, or 
                network of local registries, of families willing to 
                adopt newborns with Down syndrome or other prenatally 
                diagnosed conditions, and links to adoption agencies 
                willing to place babies with Down syndrome or other 
                prenatally diagnosed conditions, with families willing 
                to adopt; and
                    ``(E) the establishment of awareness and education 
                programs for health care providers who provide the 
                results of prenatal tests for Down syndrome or other 
                prenatally diagnosed conditions, to patients, 
                consistent with the purpose described in section 
                2(b)(1) of the Prenatal Diagnosis Support Act.
    ``(c) Data Collection.--
            ``(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 testing into 
        State-based vital statistics and birth defects surveillance 
        programs.
            ``(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 testing.
    ``(d) Provision of Information by Providers.--Upon receipt of a 
positive test result from a prenatal test for Down syndrome or other 
prenatally diagnosed conditions performed on a patient, the health care 
provider involved (or his or her designee) shall provide the patient 
with the following:
            ``(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 diagnosed conditions.
            ``(2) Referral to supportive services providers, including 
        information hotlines specific to Down syndrome or other 
        prenatally diagnosed conditions, resource centers or 
        clearinghouses, and other education and support programs as 
        described in subsection (b)(2).
    ``(e) Privacy.--
            ``(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--
                    ``(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
                    ``(B) data that are not related to the epidemiology 
                of the condition being tested for.
            ``(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).
    ``(f) Reports.--
            ``(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).
            ``(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.
    ``(g) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $5,000,000 for each of fiscal 
years 2006 through 2010.''.
                                 <all>
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