Accurate Education for Prenatal Screenings Act

Accurate Education for Prenatal Screenings Act

Amends the Public Health Service Act to direct the Centers for Disease Control and Prevention (CDC) to develop, implement, and maintain two programs, one to educate patients and one to educate health care providers regarding:

• the purposes and definitions of cell-free DNA prenatal screenings;
• the reasons for patients and providers to consider such screenings;
• the conditions such screenings may detect;
• the risks and benefits of, and alternatives to, the various methods of administering such screenings and prenatal diagnostic testing;
• the possible results of such screenings and the accuracy of such results;
• the need for diagnostic testing, and counseling by a genetics professional, for patients whose screenings yield positive, abnormal, or indeterminate results; and
• the need for communication of results to patients and appropriate follow-up per guidelines established by medical professional societies.

Requires each program to provide materials that:

• contain information that is peer-reviewed, balanced, accurate, and up-to-date;
• enable the respective target audience to understand the available options with regard to such screenings, other prenatal screenings, and diagnostic tests;
• promote the informed consent of, and enhance the decision-making processes of, the respective target audience before and after such screenings;
• contain information that appropriately addresses the diversity of the patient population; and
• contain contact information for relevant services and support organizations for patients.

Requires CDC to submit annual reports regarding:

• the development and implementation of such programs;
• the accessibility of each program to, and the adoption of each program by, its respective target audience; and
• CDC's efforts to ensure that providers and patients receive the materials created pursuant to this Act.

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3441 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 3441

To amend the Public Health Service Act to establish education programs 
for patients and health care providers regarding cell-free DNA prenatal 
                   screening, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 4, 2015

Ms. Herrera Beutler (for herself and Ms. Roybal-Allard) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to establish education programs 
for patients and health care providers regarding cell-free DNA prenatal 
                   screening, and for other purposes.

    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 ``Accurate Education for Prenatal 
Screenings Act''.

SEC. 2. CELL-FREE DNA PRENATAL SCREENING EDUCATION PROGRAMS.

    Part B of title III of the Public Health Service Act is amended by 
inserting, after section 317T (42 U.S.C. 247b-22), the following:

``SEC. 317U. CELL-FREE DNA PRENATAL SCREENING EDUCATION PROGRAMS.

    ``(a) Education Programs.--With respect to cell-free DNA prenatal 
screening, the Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall develop, implement, and 
maintain two programs, one for patients and one for health care 
providers, to educate patients and health care providers regarding 
matters including--
            ``(1) the purposes and definitions of such screenings;
            ``(2) the reasons for patients and health care providers to 
        consider such screenings;
            ``(3) the conditions such screenings may detect, including 
        accurate and up-to-date information about such conditions' 
        clinical features, prognoses, and treatments according to 
        relevant national disability organizations and medical 
        professional societies;
            ``(4) the risks and benefits of, and alternatives to, the 
        various methods of administering such screenings and prenatal 
        diagnostic testings, including the option to forego such 
        screenings and testings, as per guidelines established by 
        medical professional societies;
            ``(5) the possible results of such screenings;
            ``(6) the accuracy of the results of such screenings, 
        including positive predictive value, negative predictive value, 
        specificity, sensitivity, the inability of such screenings to 
        reliably diagnose chromosomal abnormalities, and the fact that 
        such screenings may yield false-positive and false-negative 
        results;
            ``(7) the need for diagnostic testing, and counseling by a 
        genetics professional, for patients whose screenings yield 
        positive, abnormal, or indeterminate results; and
            ``(8) the need for communication of screening results to 
        patients and appropriate follow up per guidelines established 
        by medical professional societies.
    ``(b) Materials.--Each program developed under this section shall 
include the provision of materials that--
            ``(1) contain information that is peer-reviewed, balanced, 
        accurate, and up-to-date;
            ``(2) enable the respective target audience to understand 
        the available options with regards to cell-free DNA prenatal 
        screenings, other prenatal screenings, and diagnostic tests;
            ``(3) promote the informed consent, and enhance the 
        decision-making processes of, the respective target audience 
        before and after such screenings;
            ``(4) contain information that appropriately addresses the 
        diversity of the patient population, including patients 
        proficient in languages other than English; and
            ``(5) contain contact information for relevant services and 
        support organizations for patients.
    ``(c) Assessment.--In developing, implementing, and maintaining 
programs and materials under this section, the Secretary, acting 
through the Director of the Centers for Disease Control and Prevention, 
shall--
            ``(1) consult with relevant medical professional, 
        disability support, patient advocacy, parents, and genetics 
        professionals organizations;
            ``(2) consult with companies and laboratories that perform 
        cell-free DNA prenatal screenings or develop the technologies 
        for such screenings;
            ``(3) assess and evaluate existing education activities and 
        materials for health care providers and patients related to 
        such screenings; and
            ``(4) take the results of such consultations, assessment, 
        and evaluation into account in developing educational programs 
        and materials under this section.
    ``(d) Annual Report.--Not later than 16 months after the date of 
enactment of this section and annually thereafter, the Secretary shall 
submit a progress report to the Congress with respect to--
            ``(1) the development and implementation of the education 
        programs established under this section;
            ``(2) the accessibility of each program to its respective 
        target audience;
            ``(3) the adoption of each program by its respective target 
        audience; and
            ``(4) the Secretary's efforts to ensure health care 
        providers and patients receive the materials created pursuant 
        to this section.
    ``(e) Deadline.--The Secretary shall develop and implement the 
education programs required by section 317U of the Public Health 
Service Act (as added by subsection (a)) not later than 1 year after 
the date of enactment of this Act''.
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