[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2107 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2107

   To direct the Secretary of Health and Human Services to conduct a 
 public education campaign on umbilical cord blood stem cells, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 27, 2009

  Ms. Speier introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
Education and Labor, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
   To direct the Secretary of Health and Human Services to conduct a 
 public education campaign on umbilical cord blood stem cells, 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Cord Blood 
Education and Awareness Act of 2009''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Public education campaign.
Sec. 4. Patient informed consent document.
Sec. 5. Duty of certain professionals to disclose information to, and 
                            obtain informed consent from, pregnant 
                            patients.
Sec. 6. Professional education.
Sec. 7. Targeted education grants.
Sec. 8. Authorization of appropriations.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Every 10 minutes, another child or adult is expected to 
        die from leukemia, lymphoma or myeloma. Leukemia, lymphoma, and 
        myeloma caused the deaths of an estimated 52,910 people in the 
        United States in 2007 and accounted for nearly 9.4 percent of 
        the deaths from cancer in 2008. In addition, leukemia causes 
        more deaths than any other cancer among children and young 
        adults under the age of 20.
            (2) As many as 16,000 leukemia patients diagnosed each year 
        require a bone marrow transplant but have no matched relative 
        or cannot find a match in the national bone marrow registry. 
        There is a 1 in 4 chance that an newborn baby's cord blood 
        cells would be a perfect match to a sibling that suffers from 1 
        of 70 blood diseases.
            (3) Umbilical cord blood stem cells (in this Act referred 
        to as ``cord blood cells'') have effectively been used in the 
        treatment of these conditions. To date, cord blood cells have 
        been used in more than 14,000 transplants worldwide during the 
        last 20 years.
            (4) Cord blood cells, like marrow and blood, is a rich 
        source of stem cells for allogeneic transplantation, especially 
        for children. Cord blood cells used in transplant result in a 
        lower rate of graft versus host disease than bone marrow and 
        are easier to match based on HLA typing. In addition, cord 
        blood cells have also been used to treat effectively 
        nonmalignant blood, immune, and metabolic disorders such as 
        aplastic anemia, sickle cell anemia, severe combined 
        immunodeficiencies, and leukodystrophies.
            (5) Researchers have found that in addition to blood cell 
        precursors, cord blood cells contains many different types of 
        stem cells--the building blocks of bones, the heart, liver, and 
        nervous system. Further, cord blood cells have proven to be 
        pluripotent, which means they have the ability to differentiate 
        into every cell type in the human body. Cord blood cells have 
        also been shown decrease inflammation and stimulate tissue 
        repair.
            (6) Clinical research and experimental clinical use is 
        underway to study the use of autologous cord blood cells to 
        treat type 1 diabetes, brain injury, and cerebral palsy. In 
        addition, preclinical research using cord blood cells is 
        showing promise in treating hearing loss, renal failure, spinal 
        cord injury, and congenital heart valve defects.
            (7) Of the more than 4,000,000 births in the United States 
        each year, more than 90 percent of the cord blood cells are 
        discarded as medical waste. Currently, less than one quarter of 
        the States requires that expectant parents receive information 
        regarding their options to bank their baby's cord blood in 
        public or private blood banks.
            (8) In 2005, the Institute of Medicine submitted a report 
        to Congress entitled ``Establishing National Hematopoietic Stem 
        Cell Bank Program'', and recommended that ``donors must be 
        provided with clear information about their options'', for cord 
        blood cells and that ``the information provided to a donor must 
        include a balanced perspective on the different options for 
        banking'' cord blood cells. The Institute also recommended that 
        ``informed consent for the collection storage and use of cord 
        blood should be obtained before labor and delivery, and after 
        the adequate disclosure of information.''.

SEC. 3. PUBLIC EDUCATION CAMPAIGN.

    Not later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services (in this Act referred to as 
the ``Secretary'') shall develop and make publicly available, including 
by posting on the public website of the Department of Health and Human 
Services, a publication relating to umbilical cord blood that includes 
the following information:
            (1) An explanation of the potential value and uses of 
        umbilical cord blood, including cord blood cells and stem 
        cells, for individuals who are, as well as individuals who are 
        not, biologically related to a mother or her newborn child.
            (2) An explanation of the differences between using one's 
        own cord blood cells (autologous) and using related or 
        unrelated cord blood stem cells (allogeneic use) in the 
        treatment of disease.
            (3) An explanation of the differences between public and 
        private umbilical cord blood banking.
            (4) The options available to a mother relating to stem 
        cells that are contained in the umbilical cord blood after the 
        delivery of her newborn, including--
                    (A) donating the stem cells to a public umbilical 
                cord blood bank (where facilities are available);
                    (B) storing the stem cells in a private family 
                umbilical cord blood bank for use by immediate and 
                extended family members;
                    (C) storing the stem cells for immediate or 
                extended family members through a family or sibling 
                donor banking program that provides free collection, 
                processing, and storage where there is an existing 
                medical need; and
                    (D) discarding the stem cells.
            (5) The medical processes involved in the collection of 
        cord blood.
            (6) Medical or family history criteria that can impact a 
        family's consideration of umbilical cord blood banking, 
        including the likelihood of using a baby's cord blood to serve 
        as a match for a family member who has a medical condition.
            (7) Options for ownership and future use of donated 
        umbilical cord blood.
            (8) The average cost of public and private umbilical cord 
        blood banking.
            (9) The availability of public and private cord blood 
        banks, including--
                    (A) a list of public cord blood banks within the 
                United States and the hospitals served by such banks;
                    (B) a list of private cord blood banks that are 
                accredited, as determined by the Secretary; and
                    (C) the availability of free family banking and 
                sibling donor programs where there is an existing 
                medical need by a family member.
            (10) An explanation of which racial and ethnic groups are 
        in particular need of publicly donated cord blood samples based 
        upon medical data developed by the Health Resources and 
        Services Administration.

SEC. 4. PATIENT INFORMED CONSENT DOCUMENT.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary shall develop a written patient 
informed consent document relating to cord blood disposition to be 
presented and signed, to the extent feasible, by an expectant woman not 
later than 2 weeks before her estimated delivery date.
    (b) Contents.--The document developed under subsection (a) shall 
include the following:
            (1) Information providing a balanced perspective on the 
        different options for cord blood banking, including public 
        donation, private banking, and disposal.
            (2) Information on the medical value of cord blood stem 
        cells in the treatment of disease.
            (3) A declaration, to be signed, of a woman's chosen option 
        for the disposition of a child's cord blood stem cells, whether 
        public donation, private banking, or other disposal.

SEC. 5. DUTY OF CERTAIN PROFESSIONALS TO DISCLOSE INFORMATION TO, AND 
              OBTAIN INFORMED CONSENT FROM, PREGNANT PATIENTS.

    (a) Disclosure of Options.--Effective 1 year after the date of the 
enactment of this Act, each physician or other health care professional 
who is primarily responsible for the furnishing ambulatory prenatal 
care to a pregnant woman shall--
            (1) prior to the beginning of the third trimester of the 
        pregnancy (or, if later, at the first visit of such pregnant 
        woman to the provider), provide her with information developed 
        under section 3 relating to the woman's options with respect to 
        umbilical cord blood banking; and
            (2) after providing such information and, to the extent 
        feasible, not later than 2 weeks before the woman's estimated 
        date of delivery, obtain a written informed consent described 
        in section 4 relating to the woman's decision regarding 
        disposition of cord blood stem cells or document that the 
        provider sought such consent and the woman refused or declined 
        to provide it.
    (b) Application.--
            (1) Medicaid.--
                    (A) Section 1902(a) of the Social Security Act (42 
                U.S.C. 1396b(a)) is amended--
                            (i) by striking ``and'' at the end of 
                        paragraph (72);
                            (ii) by striking the period at the end of 
                        paragraph (73) and inserting ``; and''; and
                            (iii) by inserting after paragraph (73) the 
                        following new paragraph:
            ``(74) provide (A) that each physician or other health care 
        professional who is primarily responsible for the furnishing 
        ambulatory prenatal care to a pregnant woman and who is 
        receiving funds under the plan for the furnishing of such care 
        shall comply with the requirements of such section with respect 
        to any pregnant woman to whom the provider furnishes such care; 
        and (B) for a method to enforce such requirements.''.
                    (B) Section 1903 of such Act (42 U.S.C. 1396c) is 
                amended by adding at the end the following new 
                subsection:
    ``(aa) If the Secretary finds that a State has not complied with 
the requirement of section 1902(a)(74)(B), the Secretary may provide 
for such reduction in payment otherwise made to the State under section 
1902(a)(7) as may be appropriate, taking into account the costs the 
State would have incurred in complying with such requirement.''.
            (2) CHIP.--Section 2107(e)(1) of such Act (42 U.S.C. 
        1397hh(e)(1)) is amended by adding at the end the following new 
        subparagraph:
                    ``(M) Sections 1902(a)(74) and 1903(aa) (relating 
                to informing pregnant women concerning blood cord 
                banking).''.
            (3) Employer group health plans under erisa.--Section 609 
        of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1169) is amended--
                    (A) by redesignating subsection (e) as subsection 
                (f); and
                    (B) by inserting after subsection (d) the following 
                new subsection:
    ``(e) Informing Pregnant Women Concerning Blood Cord Banking.--
            ``(1) In general.--A group health plan, and a health 
        insurance issuer that offers group health insurance coverage, 
        that provides benefits for ambulatory prenatal care for a 
        pregnant woman through an agreement or arrangement with a 
        physician or other health care professional who is primarily 
        responsible for the furnishing ambulatory prenatal care to a 
        pregnant woman shall require, as part of such agreement or 
        arrangement with the physician or other professional, that the 
        physician or professional comply with the requirements of such 
        section with respect to any pregnant woman to whom the 
        physician or professional furnishes such care.
            ``(2) Continued applicability of state law.--Section 731(a) 
        shall apply with respect to paragraph (1) in the same manner as 
        such section applies to part 7.''.
            (4) Effective date.--The amendments made by this subsection 
        shall apply to physicians and other health care professionals 
        with respect to agreements and arrangements entered into or 
        renewed on or after the date of the enactment of this Act.

SEC. 6. PROFESSIONAL EDUCATION.

    The Secretary shall develop professional educational materials on 
umbilical cord blood stem cells, including the publication developed 
under section 3, for health care providers who provide prenatal 
services to pregnant women.

SEC. 7. TARGETED EDUCATION GRANTS.

    (a) In General.--The Secretary may make grants to entities for 
targeted education on current and medically accurate information about 
umbilical cord blood stem cells and the different options for banking 
such cells.
    (b) Targeted Groups.--In making grants under this section, the 
Secretary shall consider making grants for targeted education to--
            (1) health care providers pursuant to section 6;
            (2) ethnic and racial minorities for whom public cord blood 
        samples may be difficult to find;
            (3) families with a genetic history of diseases treated by 
        cord blood; and
            (4) populations specifically affected by conditions 
        currently treated with cord blood stem cells or conditions that 
        may one day be treated with cord blood stem cells.

SEC. 8. AUTHORIZATION OF APPROPRIATIONS.

    To carry out this Act, there are authorized to be appropriated 
$10,000,000 for fiscal year 2010 and $5,000,000 for each of fiscal 
years 2011 through 2014.
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