I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Cord Blood Education and Awareness Act of 2009’’. 

6 (b) TABLE OF CONTENTS.—The table of contents of 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

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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. 

1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Every 10 minutes, another child or adult is 

4 expected to die from leukemia, lymphoma or 

5 myeloma. Leukemia, lymphoma, and myeloma 

6 caused the deaths of an estimated 52,910 people in 

7 the United States in 2007 and accounted for nearly 

8 9.4 percent of the deaths from cancer in 2008. In 

9 addition, leukemia causes more deaths than any 

10 other cancer among children and young adults under 

11 the age of 20. 

12 (2) As many as 16,000 leukemia patients diag13 nosed each year require a bone marrow transplant 

14 but have no matched relative or cannot find a match 

15 in the national bone marrow registry. There is a 1 

16 in 4 chance that an newborn baby’s cord blood cells 

17 would be a perfect match to a sibling that suffers 

18 from 1 of 70 blood diseases. 

19 (3) Umbilical cord blood stem cells (in this Act 

20 referred to as ‘‘cord blood cells’’) have effectively 

21 been used in the treatment of these conditions. To 

22 date, cord blood cells have been used in more than 

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1 14,000 transplants worldwide during the last 20 

2 years. 

3 (4) Cord blood cells, like marrow and blood, is 

4 a rich source of stem cells for allogeneic transplan5 tation, especially for children. Cord blood cells used 

6 in transplant result in a lower rate of graft versus 

7 host disease than bone marrow and are easier to 

8 match based on HLA typing. In addition, cord blood 

9 cells have also been used to treat effectively non10 malignant blood, immune, and metabolic disorders 

11 such as aplastic anemia, sickle cell anemia, severe 

12 combined immunodeficiencies, and leukodystrophies. 

13 (5) Researchers have found that in addition to 

14 blood cell precursors, cord blood cells contains many 

15 different types of stem cells—the building blocks of 

16 bones, the heart, liver, and nervous system. Further, 

17 cord blood cells have proven to be pluripotent, which 

18 means they have the ability to differentiate into 

19 every cell type in the human body. Cord blood cells 

20 have also been shown decrease inflammation and 

21 stimulate tissue repair. 

22 (6) Clinical research and experimental clinical 

23 use is underway to study the use of autologous cord 

24 blood cells to treat type 1 diabetes, brain injury, and 

25 cerebral palsy. In addition, preclinical research using 

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1 cord blood cells is showing promise in treating hear2 ing loss, renal failure, spinal cord injury, and con3 genital heart valve defects. 

4 (7) Of the more than 4,000,000 births in the 

5 United States each year, more than 90 percent of 

6 the cord blood cells are discarded as medical waste. 

7 Currently, less than one quarter of the States re8 quires that expectant parents receive information re9 garding their options to bank their baby’s cord blood 

10 in public or private blood banks. 

11 (8) In 2005, the Institute of Medicine sub12 mitted a report to Congress entitled ‘‘Establishing 

13 National Hematopoietic Stem Cell Bank Program’’, 

14 and recommended that ‘‘donors must be provided 

15 with clear information about their options’’, for cord 

16 blood cells and that ‘‘the information provided to a 

17 donor must include a balanced perspective on the 

18 different options for banking’’ cord blood cells. The 

19 Institute also recommended that ‘‘informed consent 

20 for the collection storage and use of cord blood 

21 should be obtained before labor and delivery, and 

22 after the adequate disclosure of information.’’. 

23 SEC. 3. PUBLIC EDUCATION CAMPAIGN. 

24 Not later than 1 year after the date of the enactment 

25 of this Act, the Secretary of Health and Human Services 

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1 (in this Act referred to as the ‘‘Secretary’’) shall develop 

2 and make publicly available, including by posting on the 

3 public website of the Department of Health and Human 

4 Services, a publication relating to umbilical cord blood 

5 that includes the following information: 

6 (1) An explanation of the potential value and 

7 uses of umbilical cord blood, including cord blood 

8 cells and stem cells, for individuals who are, as well 

9 as individuals who are not, biologically related to a 

10 mother or her newborn child. 

11 (2) An explanation of the differences between 

12 using one’s own cord blood cells (autologous) and 

13 using related or unrelated cord blood stem cells 

14 (allogeneic use) in the treatment of disease. 

15 (3) An explanation of the differences between 

16 public and private umbilical cord blood banking. 

17 (4) The options available to a mother relating 

18 to stem cells that are contained in the umbilical cord 

19 blood after the delivery of her newborn, including— 

20 (A) donating the stem cells to a public um21 bilical cord blood bank (where facilities are 

22 available); 

23 (B) storing the stem cells in a private fam24 ily umbilical cord blood bank for use by imme25 diate and extended family members; 

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1 (C) storing the stem cells for immediate or 

2 extended family members through a family or 

3 sibling donor banking program that provides 

4 free collection, processing, and storage where 

5 there is an existing medical need; and 

6 (D) discarding the stem cells. 

7 (5) The medical processes involved in the collec8 tion of cord blood. 

9 (6) Medical or family history criteria that can 

10 impact a family’s consideration of umbilical cord 

11 blood banking, including the likelihood of using a 

12 baby’s cord blood to serve as a match for a family 

13 member who has a medical condition. 

14 (7) Options for ownership and future use of do15 nated umbilical cord blood. 

16 (8) The average cost of public and private um17 bilical cord blood banking. 

18 (9) The availability of public and private cord 

19 blood banks, including— 

20 (A) a list of public cord blood banks within 

21 the United States and the hospitals served by 

22 such banks; 

23 (B) a list of private cord blood banks that 

24 are accredited, as determined by the Secretary; 

25 and 

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1 (C) the availability of free family banking 

2 and sibling donor programs where there is an 

3 existing medical need by a family member. 

4 (10) An explanation of which racial and ethnic 

5 groups are in particular need of publicly donated 

6 cord blood samples based upon medical data devel7 oped by the Health Resources and Services Adminis8 tration. 

9 SEC. 4. PATIENT INFORMED CONSENT DOCUMENT. 

10 (a) IN GENERAL.—Not later than 1 year after the 

11 date of the enactment of this Act, the Secretary shall de12 velop a written patient informed consent document relat13 ing to cord blood disposition to be presented and signed, 

14 to the extent feasible, by an expectant woman not later 

15 than 2 weeks before her estimated delivery date. 

16 (b) CONTENTS.—The document developed under sub17 section (a) shall include the following: 

18 (1) Information providing a balanced perspec19 tive on the different options for cord blood banking, 

20 including public donation, private banking, and dis21 posal. 

22 (2) Information on the medical value of cord 

23 blood stem cells in the treatment of disease. 

24 (3) A declaration, to be signed, of a woman’s 

25 chosen option for the disposition of a child’s cord 

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1 blood stem cells, whether public donation, private 

2 banking, or other disposal. 

3 SEC. 5. DUTY OF CERTAIN PROFESSIONALS TO DISCLOSE 

4 INFORMATION TO, AND OBTAIN INFORMED 

5 CONSENT FROM, PREGNANT PATIENTS. 

6 (a) DISCLOSURE OF OPTIONS.—Effective 1 year 

7 after the date of the enactment of this Act, each physician 

8 or other health care professional who is primarily respon9 sible for the furnishing ambulatory prenatal care to a 

10 pregnant woman shall— 

11 (1) prior to the beginning of the third trimester 

12 of the pregnancy (or, if later, at the first visit of 

13 such pregnant woman to the provider), provide her 

14 with information developed under section 3 relating 

15 to the woman’s options with respect to umbilical 

16 cord blood banking; and 

17 (2) after providing such information and, to the 

18 extent feasible, not later than 2 weeks before the 

19 woman’s estimated date of delivery, obtain a written 

20 informed consent described in section 4 relating to 

21 the woman’s decision regarding disposition of cord 

22 blood stem cells or document that the provider 

23 sought such consent and the woman refused or de24 clined to provide it. 

25 (b) APPLICATION.— 

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1 (1) MEDICAID.— 

2 (A) Section 1902(a) of the Social Security 

3 Act (42 U.S.C. 1396b(a)) is amended— 

4 (i) by striking ‘‘and’’ at the end of 

5 paragraph (72); 

6 (ii) by striking the period at the end 

7 of paragraph (73) and inserting ‘‘; and’’; 

8 and 

9 (iii) by inserting after paragraph (73) 

10 the following new paragraph: 

11 ‘‘(74) provide (A) that each physician or other 

12 health care professional who is primarily responsible 

13 for the furnishing ambulatory prenatal care to a 

14 pregnant woman and who is receiving funds under 

15 the plan for the furnishing of such care shall comply 

16 with the requirements of such section with respect to 

17 any pregnant woman to whom the provider furnishes 

18 such care; and (B) for a method to enforce such re19 quirements.’’. 

20 (B) Section 1903 of such Act (42 U.S.C. 

21 1396c) is amended by adding at the end the fol22 lowing new subsection: 

23 ‘‘(aa) If the Secretary finds that a State has not com24 plied with the requirement of section 1902(a)(74)(B), the 

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1 erwise made to the State under section 1902(a)(7) as may 

2 be appropriate, taking into account the costs the State 

3 would have incurred in complying with such require4 ment.’’. 

5 (2) CHIP.—Section 2107(e)(1) of such Act (42 

6 U.S.C. 1397hh(e)(1)) is amended by adding at the 

7 end the following new subparagraph: 

8 ‘‘(M) Sections 1902(a)(74) and 1903(aa) 

9 (relating to informing pregnant women con10 cerning blood cord banking).’’. 

11 (3) EMPLOYER GROUP HEALTH PLANS UNDER

12 ERISA.—Section 609 of the Employee Retirement 

13 Income Security Act of 1974 (29 U.S.C. 1169) is 

14 amended— 

15 (A) by redesignating subsection (e) as sub16 section (f); and 

17 (B) by inserting after subsection (d) the 

18 following new subsection: 

19 ‘‘(e) INFORMING PREGNANT WOMEN CONCERNING

20 BLOOD CORD BANKING.— 

21 ‘‘(1) IN GENERAL.—A group health plan, and a 

22 health insurance issuer that offers group health in23 surance coverage, that provides benefits for ambula24 tory prenatal care for a pregnant woman through an 

25 agreement or arrangement with a physician or other 

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1 health care professional who is primarily responsible 

2 for the furnishing ambulatory prenatal care to a 

3 pregnant woman shall require, as part of such agree4 ment or arrangement with the physician or other 

5 professional, that the physician or professional com6 ply with the requirements of such section with re7 spect to any pregnant woman to whom the physician 

8 or professional furnishes such care. 

9 ‘‘(2) CONTINUED APPLICABILITY OF STATE

10 LAW.—Section 731(a) shall apply with respect to 

11 paragraph (1) in the same manner as such section 

12 applies to part 7.’’. 

13 (4) EFFECTIVE DATE.—The amendments made 

14 by this subsection shall apply to physicians and 

15 other health care professionals with respect to agree16 ments and arrangements entered into or renewed on 

17 or after the date of the enactment of this Act. 

18 SEC. 6. PROFESSIONAL EDUCATION. 

19 The Secretary shall develop professional educational 

20 materials on umbilical cord blood stem cells, including the 

21 publication developed under section 3, for health care pro22 viders who provide prenatal services to pregnant women. 

23 SEC. 7. TARGETED EDUCATION GRANTS. 

24 (a) IN GENERAL.—The Secretary may make grants 

25 to entities for targeted education on current and medically 

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1 accurate information about umbilical cord blood stem cells 

2 and the different options for banking such cells. 

3 (b) TARGETED GROUPS.—In making grants under 

4 this section, the Secretary shall consider making grants 

5 for targeted education to— 

6 (1) health care providers pursuant to section 6; 

7 (2) ethnic and racial minorities for whom public 

8 cord blood samples may be difficult to find; 

9 (3) families with a genetic history of diseases 

10 treated by cord blood; and 

11 (4) populations specifically affected by condi12 tions currently treated with cord blood stem cells or 

13 conditions that may one day be treated with cord 

14 blood stem cells. 

15 SEC. 8. AUTHORIZATION OF APPROPRIATIONS. 

16 To carry out this Act, there are authorized to be ap17 propriated $10,000,000 for fiscal year 2010 and 

18 $5,000,000 for each of fiscal years 2011 through 2014. 

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