This is the accessible text file for GAO report number GAO-12-23 
entitled 'National Cord Blood Inventory: Practices for Increasing 
Availability for Transplants and Related Challenges' which was 
released on October 7, 2011. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as 
part of a longer term project to improve GAO products' accessibility. 
Every attempt has been made to maintain the structural and data 
integrity of the original printed product. Accessibility features, 
such as text descriptions of tables, consecutively numbered footnotes 
placed at the end of the file, and the text of agency comment letters, 
are provided but may not exactly duplicate the presentation or format 
of the printed version. The portable document format (PDF) file is an 
exact electronic replica of the printed version. We welcome your 
feedback. Please E-mail your comments regarding the contents or 
accessibility features of this document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

United States Government Accountability Office: 
GAO: 

Report to Congressional Committees: 

October 2011: 

National Cord Blood Inventory: 

Practices for Increasing Availability for Transplants and Related 
Challenges: 

GAO-12-23: 

GAO Highlights: 

Highlights of GAO-12-23, a report to congressional committees. 

Why GAO Did This Study: 

Every year, many people diagnosed with diseases such as leukemia and
lymphoma require transplants of stem cells from umbilical cord blood 
or other sources. The Stem Cell Therapeutic and Research Act of 2005 
authorized funding for banking 150,000 new units of high quality and 
genetically diverse cord blood and directed the Department of Health 
and Human Services (HHS) to contract with cord blood banks to assist 
in cord blood collection. HHS, through the Health Resources and Services
Administration (HRSA), established the National Cord Blood Inventory 
(NCBI) program to support banking of cord blood units and contracted 
with 13 cord blood banks to bank these units. The 2010 reauthorization 
required GAO to report on efforts to increase cord blood unit 
collection for the NCBI. As of May 2011, HRSA had reimbursed banks for
over 41,000 units banked for the NCBI. 

In this report, GAO describes (1) practices identified to increase
banking of cord blood units for the NCBI and related challenges and
(2) practices cord blood banks are using to lower costs and improve the
efficiency of cord blood banking and associated challenges. To do so, 
GAO reviewed relevant regulations and documents, and interviewed 
officials from pertinent organizations. These included officials from 
HRSA, the Food and Drug Administration (FDA), which is responsible for 
regulating cord blood used in transplants for patients who are not 
related to the donor, the National Marrow Donor Program (NMDP), which 
operates a national registry of cord blood units and other sources of 
stem cells, and the 13 banks with contracts to bank cord blood units 
for the NCBI. 

What GAO Found: 

The 13 banks with NCBI contracts reported various practices that could 
increase the number of cord blood units banked at existing and new 
collection sites, as well as increasing the diversity of the units 
collected. However, challenges to increasing collection for these 
banks include resource limitations, as well as competition from other 
cord blood banks, which collect units for use only by family members 
of the donor, and slowing growth in demand for U.S. cord blood units. 
Cord blood banks reported that increasing staff at collection sites, 
providing feedback to those who collect cord blood, and lowering the 
age for those donating could increase the number of units collected 
for the NCBI at existing sites. Expanding the number of collection 
sites could also increase the number and diversity of NCBI units. 
However, the banks in our review reported financial challenges related 
to increasing the number of units collected at existing or new 
collection sites, such as a limited ability to address the costs 
associated with hiring additional staff to cover more hours of 
collection or to support bank and hospital staff salaries at new 
sites. These banks identified additional practices for increasing the 
diversity of the units collected for the NCBI, but also reported that 
the units collected from some racial groups have lower volumes or cell 
counts compared to other groups, making such units less likely to meet 
standards for inclusion in the NCBI. Further, growth in sales of U.S. 
cord blood units, banks’ primary source of funding, has slowed and 
could challenge banks’ efforts. Demand for cord blood could increase 
or decrease depending on a number of variables, such as whether new 
research identifies ways to increase the benefits of cord blood or 
conversely, the development of alternative treatments to cord blood 
transplantation. 

Most of the 13 banks with NCBI contracts reported adopting practices 
to reduce costs and improve the efficiency of cord blood banking, but 
also reported some uncertainty about the effect on costs and revenues 
of complying with FDA licensure regulations that now apply to cord 
blood. These banks reported practices such as using an early screening 
process to identify units that do not meet NCBI or the bank’s own 
requirements prior to incurring the costs of processing these units. 
Further, banks with NCBI contracts reported that efforts to comply 
with applicable FDA regulations could increase the costs of banking 
cord blood. For example, some banks reported hiring external 
consultants or additional staff, reorganizing staff duties, beginning 
building renovations, or purchasing new processing equipment in 
attempts to comply with FDA regulations regarding cord blood 
manufacture and licensing. Some banks also said they were uncertain 
whether these efforts would comply with FDA requirements or if their 
collection sites would have to register with the FDA as an 
establishment that manufactures cord blood. However, FDA officials 
told GAO that neither individuals nor collection sites that have 
agreements with banks to collect units will be required to register, 
though banks must ensure the collection sites comply with FDA 
regulations. Further, some banks also reported that they were 
uncertain whether potential increased revenue from licensed units will 
offset their costs of cord blood banking. 

HHS provided additional information regarding our findings, which was
incorporated as appropriate. 

View [hyperlink, http://www.gao.gov/products/GAO-12-23] or key 
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

Banks Reported a Number of Practices and Challenges Related to 
Increasing Units Banked: 

Most Banks Have Adopted Practices to Reduce Costs, but Are Uncertain 
about the Effect of Regulations on Costs and Revenues: 

Concluding Observations: 

Agency Comments: 

Appendix I: Comments from the Department of Health and Human Services: 

Appendix II: GAO Contact and Staff Acknowledgments: 

Table: 

Table 1: Racial and Ethnic Composition of U.S. Cord Blood Units and 
U.S. Adult Donors in National Marrow Donor Program's Registry as of 
May 31, 2011: 

Figure: 

Figure 1: U.S. Cord Blood Units from National Marrow Donor Program's 
Registry Shipped for Transplant and Facilitated by NMDP, January 2005 
through May 2011: 

Abbreviations: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

HLA: human leukocyte antigens: 

HRSA: Health Resources and Services Administration: 

IND: investigational new drug: 

NCBI: National Cord Blood Inventory: 

NMDP: National Marrow Donor Program: 

[End of section] 

United States Government Accountability Office
Washington, DC 20548: 

October 7, 2011: 

Congressional Committees: 

Every year, thousands of people are diagnosed with diseases such as 
leukemia and lymphoma, which damage their blood-forming cells. Many of 
these patients require transplants of stem cells from umbilical cord 
blood or the bone marrow or bloodstream of an adult donor to supply 
healthy blood-forming cells.[Footnote 1] While the best match for such 
a transplant is cells from a sibling or other family member, the 
majority of patients will not find a matching donor in their families 
and must rely on stem cells from other sources, such as those from 
unrelated adult donors or umbilical cord blood. In 2005, the number of 
usable cord blood units[Footnote 2] in the United States available to 
the public for transplant was estimated to be about 44,000 units, 
according to an Institute of Medicine report.[Footnote 3] In 
recognition of the need for high quality and genetically diverse units 
to help those who need a cord blood transplant, Congress passed the 
Stem Cell Therapeutic and Research Act of 2005 (Stem Cell Act). 
[Footnote 4] 

The Stem Cell Act directed the Secretary of Health and Human Services 
(HHS) to enter into contracts with cord blood banks to assist in the 
collection and maintenance--known as banking--of 150,000 new units of 
high quality and genetically diverse cord blood.[Footnote 5] The act 
directed that these units be made available for transplantation and 
authorized the appropriation of $60 million in federal funds through 
fiscal year 2010. HHS, through the Health Resources and Services 
Administration (HRSA), established the National Cord Blood Inventory 
(NCBI) program, which supports the banking of stem cells derived from 
umbilical cord blood for use in transplantation. 

The Stem Cell Therapeutic and Research Reauthorization Act of 2010 
[Footnote 6] (Reauthorization Act) changed the number of cord blood 
units that are to be available from the NCBI from a total of 150,000 
to "at least" 150,000 cord blood units and placed new emphasis on 
actions such as exploring innovations in cord blood collection and 
increasing the number of collection sites.[Footnote 7] The 
Reauthorization Act authorized additional federal funds to support the 
growth of publicly available cord blood units and in meeting the 
inventory goal of the Stem Cell Act to increase the genetic diversity 
of the supply to improve the probability that all racial and ethnic 
groups might find a suitable cord blood unit. 

Since fiscal year 2007, HRSA has entered into contracts with 13 cord 
blood banks (banks) to contribute cord blood units to the NCBI. Each 
contract specifies goals--by racial and ethnic group--for the number 
of cord blood units to be banked for the NCBI under that contract. 
[Footnote 8] As of May 31, 2011, HRSA had reimbursed these banks $45.7 
million for more than 41,000 cord blood units that were banked under 
contracts for the NCBI.[Footnote 9] One condition of contracts with 
HRSA for the NCBI is that the banks will list the units banked for the 
inventory on a registry maintained by the Cord Blood Coordinating 
Center,[Footnote 10] which is operated by the National Marrow Donor 
Program (NMDP) under a contract with HRSA.[Footnote 11] NMDP's 
registry is the largest registry worldwide, where physicians and 
others can search for a stem cell match for patients who need 
transplants. 

The Reauthorization Act required GAO to submit a report reviewing 
efforts to increase cord blood unit donation and collection for the 
NCBI to ensure a high quality and genetically diverse inventory of 
cord blood units. In this report, we describe (1) practices identified 
to increase banking of cord blood units for the NCBI and related 
challenges, and (2) practices cord blood banks are using to lower the 
costs and improve the efficiency of cord blood banking and associated 
challenges. 

To describe the practices identified to increase banking of cord blood 
units for the NCBI and related challenges, we interviewed officials 
from HRSA, NMDP, and the 13 banks that have contracts with HRSA for 
the NCBI. We also attended meetings of the Advisory Council on Blood 
Stem Cell Transplantation (Advisory Council) and reviewed Advisory 
Council meeting minutes and reports.[Footnote 12] We obtained and 
analyzed reports, publications, and other documents, including those 
about studies, demonstration programs, and outreach efforts conducted 
in response to the 2005 Stem Cell Act that focused on efforts to 
increase the NCBI. We analyzed the NCBI contracts and NMDP data to 
identify information about goals for collecting cord blood from 
various racial and ethnic groups, the numbers of cord blood units in 
this inventory, and HRSA reimbursement rates for cord blood units 
stored in the NCBI. To assess the reliability of NMDP's data about 
cord blood units and adult donors listed in NCBI and NMDP's registry, 
we reviewed relevant documentation about the data and interviewed 
officials about how the data were compiled. We determined that the 
data we used for our report were sufficiently reliable for our 
purposes. 

To describe the practices banks use to lower costs and improve the 
efficiency of cord blood banking and associated challenges, we 
interviewed representatives from the 13 banks that have HRSA contracts 
for the NCBI, along with HRSA and NMDP officials. We also attended 
relevant NMDP and Advisory Council meetings that focused on the 
financial components of cord blood banking. We reviewed guidance 
promulgated by the Food and Drug Administration (FDA) in October 2009 
that provides recommendations for how to comply with applicable 
regulatory requirements for licensure of cord blood units, including 
required activities such as testing, processing, and storage of units. 
We also reviewed the applicable FDA regulations and interviewed FDA 
officials. We also reviewed scientific literature about stem cell 
technologies. 

For each of our interviews with the 13 cord blood banks, we used a 
question set that included open-ended questions about cord blood 
banking activities. These activities included increasing the number of 
cord blood donors from various racial and ethnic groups, expanding the 
number of cord blood units collected at existing collection sites, 
lowering costs and improving efficiency when collecting and processing 
cord blood, and complying with regulatory and administrative 
requirements associated with cord blood banking, including FDA 
requirements. The open-ended questions asked banks to consider the 
cord blood banking activities and, for each activity, to describe (1) 
challenges or barriers the cord blood bank experienced related to this 
activity; (2) practices, innovations, or incentives used successfully 
or heard of by the bank; and (3) any other practices, incentives, or 
technology that could increase the number and genetic diversity of 
cord blood units in the NCBI. The cord blood bank officials we 
interviewed provided varying levels of detail when answering our open-
ended questions, and may not have provided an exhaustive list of all 
challenges or barriers cord blood banks have experienced, or all 
practices, innovations, or incentives that cord blood banks have used 
or identified. 

We conducted our work from March 2011 through September 2011 in 
accordance with all sections of GAO's Quality Assurance Framework that 
are relevant to our objectives. The framework requires that we plan 
and perform the engagement to obtain sufficient and appropriate 
evidence to meet our stated objectives and to discuss any limitations 
in our work. We believe that the information and data obtained, and 
the analysis conducted, provide a reasonable basis for any findings 
and conclusions in this product. 

Background: 

Stem cells from healthy, unrelated donors have been used to treat 
patients with a variety of diseases, and are considered an appropriate 
course of treatment for numerous forms of leukemia, lymphoma, and 
other blood, metabolic, and immune-deficiency disorders. The first 
source of stem cells used for transplant was bone marrow, but now stem 
cells from the bloodstream and cord blood can also be used. The 
success of stem cell transplants depends, among other things,[Footnote 
13] on the extent to which certain blood cell proteins that are part 
of every donor's genetic make-up--human leukocyte antigens (HLA)--
match those in the patient.[Footnote 14] In general, the more closely 
related two people are, the more likely it is that their HLA will 
match. The HLA of members of different racial groups are typically 
less likely to match one another. 

There is evidence that cord blood may not require as exact a match as 
stem cells from bone marrow or the bloodstream because the antigens in 
cord blood are less mature. This characteristic means that transplants 
involving HLA-compatible stem cells from cord blood are less likely to 
result in graft versus host disease because the donor's cells are less 
likely to perceive the patient's cells as foreign bodies and attack 
them.[Footnote 15] This makes cord blood especially valuable to 
patients for whom a complete match cannot be found. Persons for whom a 
complete match may be difficult to find include those from communities 
with greater genetic diversity, such as African Americans and persons 
of mixed ethnic heritage. A broad selection of cord blood provides 
persons with rare HLA types greater access to stem cell 
transplantation. 

In the event that a patient cannot find a sibling or other family 
member to donate, an HLA match may be sought among the stem cells 
donated and listed in transplant registries. While there are over 60 
stem cell donor registries worldwide, NMDP operates the largest 
registry,[Footnote 16] which is a database of information about cord 
blood units and adults[Footnote 17] who are willing to donate stem 
cells from their bone marrow or bloodstream (adult donors). As of May 
31, 2011, NMDP's registry included more than 6.5 million U.S. adult 
donors and nearly 135,000 cord blood units collected in the United 
States, of which almost 41,000 are from the NCBI.[Footnote 18] In 
January 2011, NMDP estimated that at least 86 percent of most racial 
and ethnic groups have a close match using all available sources of 
stem cells listed in its registry.[Footnote 19] Transplant centers may 
also find a suitable match through other U.S. and international 
registries.[Footnote 20] 

Table 1 provides a breakdown by racial and ethnic group of the U.S. 
cord blood units and adult donors in NMDP's registry. The NCBI is more 
diverse for some racial and ethnic groups compared to the inventory of 
cord blood units not in the NCBI or adult donors in NMDP's registry. 
For example, 14 percent of the NCBI units are from Black/African 
American donors, compared to 6 percent of those U.S. cord blood units 
not in the NCBI, and 10 percent of adult donors registered in the 
United States. 

Table 1: Racial and Ethnic Composition of U.S. Cord Blood Units and 
U.S. Adult Donors in National Marrow Donor Program's Registry as of 
May 31, 2011: 

Racial/ethnic category: American Indian/Alaskan Native[C]; 
Cord blood unit inventories: NCBI units: 40; 
Cord blood unit inventories: Percent of NCBI units: 0[D]; 
Cord blood unit inventories: Non-NCBI units: 212; 
Cord blood unit inventories: Percent of Non-NCBI units: 0[D]; 
Adult donor inventory: Adult donors[A]: 77,237; 
Adult donor inventory: Percent of adult donors: 1%; 
Total of units and donors[B]: 77,489; 
Percent of total units and donors[B]: 1%. 

Racial/ethnic category: Asian[C]; 
Cord blood unit inventories: NCBI units: 1,760; 
Cord blood unit inventories: Percent of NCBI units: 4%; 
Cord blood unit inventories: Non-NCBI units: 3,304; 
Cord blood unit inventories: Percent of Non-NCBI units: 4%; 
Adult donor inventory: Adult donors[A]: 664,509[E]; 
Adult donor inventory: Percent of adult donors: 10%; 
Total of units and donors[B]: 669,573; 
Percent of total units and donors[B]: 10%. 

Racial/ethnic category: Black/African American[C]; 
Cord blood unit inventories: NCBI units: 5,502; 
Cord blood unit inventories: Percent of NCBI units: 14; 
Cord blood unit inventories: Non-NCBI units: 5,957; 
Cord blood unit inventories: Percent of Non-NCBI units: 6; 
Adult donor inventory: Adult donors[A]: 657,648; 
Adult donor inventory: Percent of adult donors: 10; 
Total of units and donors[B]: 669,107; 
Percent of total units and donors[B]: 10. 

Racial/ethnic category: Caucasian[F]; 
Cord blood unit inventories: NCBI units: [Empty]; 
Cord blood unit inventories: Percent of NCBI units: [Empty]; 
Cord blood unit inventories: Non-NCBI units: [Empty]; 
Cord blood unit inventories: Percent of Non-NCBI units: [Empty]; 
Adult donor inventory: Adult donors[A]: 3,936,322; 
Adult donor inventory: Percent of adult donors: 60%; 
Total of units and donors[B]: 3,936,322; 
Percent of total units and donors[B]: 59%. 

Racial/ethnic category: Caucasian - Hispanic; 
Cord blood unit inventories: NCBI units: 12,230; 
Cord blood unit inventories: Percent of NCBI units: 30; 
Cord blood unit inventories: Non-NCBI units: 9,269; 
Cord blood unit inventories: Percent of Non-NCBI units: 10%; 
Adult donor inventory: Adult donors[A]: [Empty]; 
Adult donor inventory: Percent of adult donors: [Empty]; 
Total of units and donors[B]: 21,499; 
Percent of total units and donors[B]: 0[D]. 

Racial/ethnic category: Caucasian - non-Hispanic; 
Cord blood unit inventories: NCBI units: 16,772; 
Cord blood unit inventories: Percent of NCBI units: 41; 
Cord blood unit inventories: Non-NCBI units: 55,157; 
Cord blood unit inventories: Percent of Non-NCBI units: 59%; 
Adult donor inventory: Adult donors[A]: [Empty]; 
Adult donor inventory: Percent of adult donors: [Empty]; 
Total of units and donors[B]: 71,929; 
Percent of total units and donors[B]: 1%. 

Racial/ethnic category: Hispanic - no race identified; 
Cord blood unit inventories: NCBI units: 0; 
Cord blood unit inventories: Percent of NCBI units: 0; 
Cord blood unit inventories: Non-NCBI units: 5,318; 
Cord blood unit inventories: Percent of Non-NCBI units: 6%; 
Adult donor inventory: Adult donors[A]: 831,731; 
Adult donor inventory: Percent of adult donors: 13%; 
Total of units and donors[B]: 837,049; 
Percent of total units and donors[B]: 13%. 

Racial/ethnic category: Multi-race[G]; 
Cord blood unit inventories: NCBI units: 4,373; 
Cord blood unit inventories: Percent of NCBI units: 11%; 
Cord blood unit inventories: Non-NCBI units: 9,487; 
Cord blood unit inventories: Percent of Non-NCBI units: 10%; 
Adult donor inventory: Adult donors[A]: 370,344; 
Adult donor inventory: Percent of adult donors: 6%; 
Total of units and donors[B]: 384,204; 
Percent of total units and donors[B]: 6%. 

Racial/ethnic category: Native Hawaiian/Pacific Islander[C]; 
Cord blood unit inventories: NCBI units: 54; 
Cord blood unit inventories: Percent of NCBI units: 0[D]; 
Cord blood unit inventories: Non-NCBI units: 85; 
Cord blood unit inventories: Percent of Non-NCBI units: 0[D]; 
Adult donor inventory: Adult donors[A]: 0; 
Adult donor inventory: Percent of adult donors: 0; 
Total of units and donors[B]: 139; 
Percent of total units and donors[B]: 0[D]. 

Racial/ethnic category: Other[H]; 
Cord blood unit inventories: NCBI units: 0; 
Cord blood unit inventories: Percent of NCBI units: 0; 
Cord blood unit inventories: Non-NCBI units: 5,291; 
Cord blood unit inventories: Percent of Non-NCBI units: 6; 
Adult donor inventory: Adult donors[A]: 0; 
Adult donor inventory: Percent of adult donors: 0; 
Total of units and donors[B]: 5,291; 
Percent of total units and donors[B]: 0[D]. 

Racial/ethnic category: Total; 
Cord blood unit inventories: NCBI units: 40,731; 
Cord blood unit inventories: Percent of NCBI units: 100%; 
Cord blood unit inventories: Non-NCBI units: 94,080; 
Cord blood unit inventories: Percent of Non-NCBI units: 100%; 
Adult donor inventory: Adult donors[A]: 6,537,791; 
Adult donor inventory: Percent of adult donors: 100%; 
Total of units and donors[B]: 6,672,602; 
Percent of total units and donors[B]: 100%. 

Source: GAO analysis of National Marrow Donor Program data. 

[A] Includes adult donors recruited by U.S. donor centers, U.S. 
recruitment centers, and other U.S. member registries. 

[B] Due to differences in the racial and ethnic classification for 
cord blood units and adult donors, the total numbers and percentages 
of the total by racial and ethnic group are approximate only. 

[C] For cord blood units, this category includes persons of Hispanic 
ethnicity. 

[D] The percentage for this category was greater than zero, but less 
than one. 

[E] Includes Native Hawaiian/Pacific Islanders. 

[F] For adult donors, the Caucasian category includes persons of 
Hispanic ethnicity. 

[G] For cord blood units, Multi-race includes persons reporting two or 
more races. For adult donors, Multi-race includes persons reporting 
two or more races as well as Hispanic ethnicity plus Black/African- 
American, Asian, Native Hawaiian/Pacific Islander, or American Indian/ 
Alaskan Native. 

[H] Other includes National Marrow Donor Program categories of Other, 
Decline, or Unknown. 

[End of table] 

Of all the U.S. cord blood units listed on NMDP's registry, between 
January 2005 and May 2011 NMDP facilitated the shipment of 5,554 units 
throughout the world for use in transplants. About 28 percent of these 
units were sent to transplant centers outside the United States. 
Similarly, U.S. transplant centers import cord blood units from 
outside the United States. As illustrated in figure 1, among U.S. cord 
blood units listed on the NMDP registry, and for which NMDP 
facilitated shipment, those from the NCBI represent a growing 
percentage of cord blood units shipped for use in transplants. 
[Footnote 21] In the first 5 months of 2011, 52 percent of the U.S. 
units in the registry that were sold for use in transplants were from 
the NCBI. 

Figure 1: U.S. Cord Blood Units from National Marrow Donor Program's 
Registry Shipped for Transplant and Facilitated by NMDP, January 2005 
through May 2011: 

[Refer to PDF for image: vertical bar graph] 

Year: 2005; 
NCBI: 0; 
Non-NCBI: 303. 

Year: 2006; 
NCBI: 0; 
Non-NCBI: 515. 

Year: 2007; 
NCBI: 13; 
Non-NCBI: 750. 

Year: 2008; 
NCBI: 158; 
Non-NCBI: 802. 

Year: 2009; 
NCBI: 462; 
Non-NCBI: 685. 

Year: 2010; 
NCBI: 559; 
Non-NCBI: 687. 

Year: January-May 2011; 
NCBI: 320; 
Non-NCBI: 300. 

Source: GAO analysis of National Marrow Donor Program data. 

[End of figure] 

A challenge associated with cord blood as a source of stem cells is 
the small number of cells contained in a typical cord blood unit, 
which may not be sufficient for a heavier patient. The higher the 
number of stem cells infused into a transplant patient, the better the 
outcome. The median number of blood cells in a typical cord blood unit 
listed in the NMDP registry is 1.07 billion cells, which is sufficient 
to provide a patient weighing 94 pounds or less a minimum therapeutic 
dose.[Footnote 22] An adult bone marrow or bloodstream donor, on 
average, would provide the same patient with a dose of cells that is 
many times that which is provided by a single cord blood unit with a 
median number of cells. 

Cord Blood Banking for the NCBI: 

Thirteen banks are currently under contract with HRSA to contribute 
cord blood units to the NCBI and list the units on the NMDP registry. 
[Footnote 23] Each contract specifies goals--by racial and ethnic 
group--for the number of cord blood units to be banked under that 
contract. Some of the banks with HRSA contracts are engaged only in 
cord blood banking while others are subsidiaries of larger 
organizations such as a university, hospital, or community blood 
center. Eleven of the 13 banks under contract with HRSA are nonprofit 
organizations. As a part of their banking activities, the cord blood 
banks recruit donors, collect cord blood, process and store units, and 
distribute the units for transplant and research.[Footnote 24] 

Initial education about cord blood donation may be provided by the 
mother's obstetrician, or from communications from radio, TV, or print 
sources. Recruitment of a potential donor mother is often done by cord 
blood banking staff at the hospital upon her arrival to deliver her 
baby but prior to active labor.[Footnote 25] Recruitment includes 
informing the mother about cord blood donation and the benefits of 
public donation, conducting eligibility screening by administering a 
maternal questionnaire and a family medical history, and obtaining the 
donor mother's informed consent.[Footnote 26] Under NCBI requirements, 
donor mothers may not give informed consent during active labor. 

The 13 banks under contract with HRSA collect cord blood at 114 
hospitals--referred to as collection sites--in 24 states.[Footnote 27] 
NCBI banks have written agreements with collection sites permitting 
bank staff, hospital staff, obstetricians, or midwives to collect the 
cord blood. The collection methods vary by site and can include an 
obstetrician collecting during a cesarean section; an obstetrician, 
midwife, or nurse collecting during a vaginal delivery in the second 
stage of labor; a member of the bank's staff collecting after the 
placenta has been delivered; or any combination of these practices. 
Once collected, the cord blood is placed into a tamper-proof, 
temperature-monitored container for ground or air transport from the 
collection site to the cord blood bank. 

Upon receipt at the bank, lab personnel check the paperwork and 
integrity of the cord blood unit. The cord blood is weighed and 
evaluated for any exposure to extreme temperature changes since 
collection and then processed. Processing includes various steps such 
as separating the stem cells from the cord blood; testing the stem 
cells for potency, viability, and for infectious disease; identifying 
their genetic characteristics; and freezing and storing the unit. 
[Footnote 28] The bank enters data about the cord blood unit, the 
mother, and the family medical history into an NMDP database for 
inclusion in NMDP's national registry. The unit will be searchable on 
the NMDP registry after its sterility is confirmed. If the unit meets 
HRSA's criteria for the inventory and the bank has not yet met its 
collection goals under its contract, the unit becomes part of the 
NCBI. [Footnote 29] 

HRSA Pilot Project for Remote Collections: 

In 2009, HRSA initiated a pilot project for remote collections--that 
is, collections at sites other than those with which a bank has a 
written agreement. Remote collections through the pilot are performed 
by physicians or midwives using a cord blood unit collection kit that 
was provided to eligible mothers by one of the banks participating in 
the pilot. The pilot provides HRSA with data to evaluate the 
feasibility and utility of the remote collections and inform future 
decisions to potentially expand the program as a national model for 
remote collections. It might also provide opportunities to donors who 
otherwise would be unable to donate because there is no collection 
site in their area; however, units that are remotely collected cannot 
currently be added to the NCBI. HRSA officials have said that they are 
uncertain about whether these units will meet FDA requirements for 
licensure. In commenting on a draft of this report, HHS noted that 
HRSA would be willing to revisit the exclusion of these units from the 
NCBI if they are able to be licensed. 

HRSA Contracts with Cord Blood Banks: 

HRSA has awarded contracts to the cord blood banks, based on 
requirements set out in the Stem Cell Act, through a competitive 
request-for-proposal process. The act required that the contracts be 
for 10 years and required HRSA to ensure that no funds would be 
obligated under the contracts 3 years after the contracts were entered 
into.[Footnote 30] HRSA requires banks to make NCBI cord blood units 
available for transplant indefinitely, or for as long as they are 
determined viable by HHS.[Footnote 31] The Reauthorization Act 
authorized HRSA to obligate funds under new contracts for up to 5 
years and to extend the contract period to 10 years past the last date 
the bank received funds under the contract.[Footnote 32] HRSA 
incorporated these changes into its most recent request-for-proposals 
for new contracts issued on June 15, 2011. HRSA officials said that 
they are modifying their existing contracts to reflect this change. 

As part of the competitive award process, each bank proposes the 
number of units, by racial and ethnic group, that it will place into 
the NCBI annually. HRSA uses collection and banking of cord blood 
units within these racial and ethnic groups as a means of increasing 
the genetic diversity of the NCBI. The banks' proposed racial and 
ethnic targets are then subject to negotiations with HRSA and become 
part of the contract between HRSA and the bank. Since HRSA began 
contracting for cord blood units for the NCBI, it has indicated to 
prospective banks that when awarding contracts, special consideration 
would be given to banks that demonstrated a superior ability to 
collect and bank large numbers of cord blood units from 
underrepresented populations, especially African Americans. In 
addition, in 2009, HRSA began to negotiate reimbursement rates that 
varied depending on the racial and ethnic status of the unit. HRSA now 
pays banks higher rates for units collected from minority groups 
compared to the rates HRSA pays for units collected from the non-
Hispanic Caucasian group. 

HRSA's reimbursement rate for each cord blood unit banked for the NCBI 
is negotiated with each bank. HRSA and NMDP estimate that a bank's 
cost for each cord blood unit placed on the registry is between $1,500 
and $2,500. Once awarded a contract, a bank submits invoices to HRSA 
for payment for units placed on NMDP's registry during the invoice 
period. Only cord blood units that meet HRSA requirements may be 
reimbursed by HRSA and placed in the NCBI. HRSA requirements include 
having a minimum blood cell count per unit of 900 million, a special 
procedure for wrapping the unit prior to freezing, and a 48-hour 
deadline for collection, processing, and freezing.[Footnote 33] 

Since the first contract became effective in November 2006, per unit 
reimbursement rates negotiated by HRSA have ranged from $648 to $1,637 
with an average payment of $1,110 per unit.[Footnote 34] HRSA does not 
pay the complete costs of banking the unit in order to encourage the 
bank to seek out other sources of revenue. The largest source of 
revenue for the banks comes from the sale of cord blood units for 
transplantation. According to a limited financial analysis[Footnote 
35] of the public cord blood banking industry conducted by NMDP in 
2010, 81 percent of the industry's operating costs are covered by 
sales of cord blood units for transplantation.[Footnote 36] As of 
August 2011, banks received payments ranging from $22,800 to $35,000 
for cord blood units used for transplantation, with a median payment 
of $30,000. Other sources of revenue include charitable contributions, 
excess revenues from other lines of business engaged in by the bank or 
its parent organization, and HRSA reimbursement for units banked for 
the NCBI. 

Advisory Council on Blood Stem Cell Transplantation: 

The Advisory Council was created by the 2005 Stem Cell Act and advises 
the Secretary of HHS and the Administrator of HRSA on how to carry out 
activities associated with managing the NCBI. The council consists of 
up to 25 members, including cord blood and bone marrow donor centers, 
banks, transplant centers, and recipients. The members participate in 
workgroups that cover specific topics related to stem cell 
transplantation, such as cord blood collection. The workgroups then 
develop and present the entire Advisory Council with recommendations 
that could be made to the Secretary of HHS and HRSA about how the NCBI 
should function. 

The Food and Drug Administration's Regulation of Cord Blood: 

The FDA regulates cord blood for use in transplants when the patient 
is not related to the donor. FDA requires, among other things, that 
public cord blood banks register with FDA, screen potential donors for 
certain diseases according to FDA eligibility criteria, and comply 
with Current Good Manufacturing Practice, Current Good Tissue 
Practice, and applicable regulations. Until October 20, 2011, banks 
can voluntarily distribute cord blood units[Footnote 37] for use in 
transplants--when the patient is not related to the cord blood donor--
as an investigational new drug (IND).[Footnote 38] Effective October 
20, 2011, all cord blood units, including those currently in cord 
blood bank inventories, will have to be approved for use by the FDA as 
an IND or under an FDA-approved license.[Footnote 39] As of August 
2011, none of the banks had an approved license for cord blood, though 
many were using their own or NMDP's existing IND approvals. Two cord 
blood banks have submitted license applications, and eleven banks have 
either completed or scheduled meetings with FDA to discuss the license 
application process. 

Banks Reported a Number of Practices and Challenges Related to 
Increasing Units Banked: 

Banks reported practices that they believe could increase collections 
at existing sites, but noted that increased expenditures and other 
factors could present challenges to banking cord blood. Expanding the 
number of collection sites could also increase the number and 
diversity of cord blood units in the NCBI, but banks reported funding 
challenges related to establishing new sites. Banks also reported 
additional practices to increase the genetic diversity of the NCBI, 
but certain characteristics of the cord blood units collected from 
various racial groups may limit the number of units banked. Remote 
collection of cord blood units is under consideration. Finally, sales 
of cord blood units have slowed and could challenge banks' efforts to 
increase the NCBI. 

Banks Reported Practices That Could Increase Collections at Existing 
Sites, but Increased Expenditures and Other Factors Could Present 
Challenges: 

Ten of the 13 banks that we interviewed told us that the following 
practices could increase the number of cord blood units collected at 
existing collection sites: 

* Adding more staff at collection sites during more hours of the day 
and/or more days of the week. For example, one bank said that they are 
currently losing the opportunity to collect from 25 percent of the 
women who deliver on the weekends because they do not have staff 
working 24 hours a day on weekends. 

* Providing recognition or feedback to motivate medical staff about 
their cord blood collections. Eight banks told us that they use this 
practice, and several of these banks noted that this has resulted in 
increased collections or improved the quality of collection practices, 
which results in better cord blood units with high volumes and cell 
counts. Such feedback can also include letting collectors know if the 
units that they collected did not meet the bank's standards. 

* Lowering the age of consent for donating cord blood. For example, 
one bank said it could collect more cord blood units if the age of 
consent was lowered, particularly at one hospital that serves many 
women under the age of 18, which is HRSA's current age requirement. In 
May 2011, the Advisory Council recommended that HRSA broaden the 
definition of the minimal eligible maternal age for consenting to 
donate cord blood to reflect the law in each state. As a result, the 
age of maternal emancipation could be used, which in some states is 
lower than 18. HRSA officials told us that they are implementing this 
change in their fiscal year 2011 contracts and in modifications to 
existing contracts. 

Resource limitations, as well as competition from private cord blood 
banks, could make increasing collections at existing sites 
challenging.[Footnote 40] Three of the five banks who discussed adding 
staff to increase collections noted that they have limited ability to 
address the increase in expenditures associated with hiring additional 
staff to cover more hours of collection. Some banks said that they 
receive additional funds from donations and financial support from 
parent organizations--in addition to HRSA's reimbursement and cord 
blood sales--to cover their total cost of operations. Four banks also 
reported that competition from private banking at the hospital where 
they are collecting reduces their opportunity for collections as some 
mothers choose to privately bank their cord blood. For example, one 
bank said that at hospitals with more affluent patients, the loss of 
available cord blood units to private banking can exceed 20 percent of 
the deliveries. 

Another challenge reported by four banks was that bank staff must 
provide continuous opportunities for hospital staff to learn how to 
collect cord blood due, in part, to turnover of the medical staff 
collecting cord blood units. For example, residents who are trained to 
collect cord blood may later move to their next medical rotation or to 
another hospital. Additionally, one bank said having bank staff 
routinely conduct training about cord blood collection at the hospital 
helps ensure the proficiency levels of trained collectors in 
collecting high quality units by reinforcing proper methods. However, 
these continuous training requirements force banks to dedicate staff 
hours to training and reduce their ability to use them to expand hours 
to support cord blood collections. 

Expanding the Number of Collection Sites Could Increase the Size and 
the Diversity of the NCBI, but Banks Reported Challenges Funding New 
Sites: 

Another way to increase the number of units in the NCBI, and the 
inventory's diversity, is to expand the number of collection sites, 
especially if banks can identify collection sites that will add to the 
racial and ethnic diversity of their collections. When considering new 
collection sites, most of the banks we interviewed reported focusing 
on those sites with a large number of deliveries or those with 
significant racial and ethnic diversity among their deliveries. Eight 
of the 13 banks reported using one of the following practices related 
to expanding collections to sites with a high number of minority 
births. These include: 

* Using hospital census data to target hospitals with a high number of 
minority births. Some banks try to ascertain the ethnic composition of 
the deliveries at a hospital before approaching the hospital as a 
potential collection site. 

* Building on existing relationships with collection sites served by 
the bank's parent organization. For example, some banks are also part 
of a community blood center. Hospitals that use the community blood 
center's services may be encouraged to also operate as a cord blood 
collection site. 

* Working with advocacy groups that support cord blood banking to 
encourage collection sites to participate. One cord blood bank said 
that it has added collection sites as a result of their relationships 
and networking with advocacy groups and foundations. 

Twelve of the banks we interviewed identified at least one of the 
following challenges to adding new collection sites. First, banks 
reported that they must finance the costs for new collection sites, 
including bank and hospital staff salaries, supplies, and expenses 
associated with transporting cord blood, because HRSA does not provide 
specific funding to defray these costs. Some banks reported being 
contacted by hospitals that are interested in becoming cord blood 
collection sites, but the banks say they are limited in the number of 
sites they can add because of the expense of adding new sites. HRSA 
officials agreed that it is expensive to add new collection sites. 
They reported that the agency is encouraging efforts to increase 
collections in the most efficient manner, consistent with available 
resources. HRSA officials also said that as long as capacity for 
additional cord blood collections remains at current collection sites, 
the agency believes that increasing activity at those sites may be the 
most efficient means of increasing annual collections. HRSA officials 
said they do not plan to estimate the number of collection sites to 
meet the NCBI goal of at least 150,000 units because there are 
multiple variables to consider when trying to estimate the number of 
collection sites needed. Instead, the agency is encouraging efforts to 
increase collections at existing sites. The 13 banks providing cord 
blood units to the NCBI have agreements with between 2 and 33 
collection sites, depending on the bank, for a total of 114 collection 
sites. A second challenge banks reported was the amount of time they 
spend developing agreements to collect at sites because of multiple 
reviews, such as the site's agreement having to be approved by 
different departments within a hospital. 

Finally, one bank reported that a challenge that is specific to 
expanding to a new collection site with a large number of racial and 
ethnic deliveries is that these sites are more likely to be 
understaffed; therefore, nurses and physicians have less time to 
participate in cord blood collection. The bank reported that when they 
approach the administration of such hospitals the administration is 
less likely to agree to participate in cord blood collection because 
of the additional workload collecting cord blood will place on their 
staff. 

Whether the bank is trying to increase cord blood collection at an 
existing site or by adding a new site, the banks reported the 
following practices: identifying a "champion" associated with the 
collection site, such as a doctor or administrator, to support the 
site's collection efforts and to motivate staff to collect cord blood; 
providing bank staff or paying the salaries of hospital staff to carry 
out some or all of the collection activities at each site; 
contributing to the nurses' education fund at the site; or paying for 
space to use for collection activities. 

Banks Reported Additional Practices for Increasing the Genetic 
Diversity of the NCBI, but Characteristics Associated with Some Units 
Pose Challenges: 

In addition to adding new collection sites with diverse populations, 6 
of the 13 banks that we interviewed reported specific practices to 
recruit donors and bank cord blood from various racial and ethnic 
groups in order to increase collections that enhance the genetic 
diversity of the NCBI. For example, some of the banks have tried to 
reach more African American donors through outreach to community 
groups such as churches, health fairs, schools, and support groups, 
such as Mocha Moms, Inc., rather than through events that are 
conducted in concert with medical practices. As another example, some 
banks use bilingual recruiters and educational materials to recruit 
Hispanic donors. One bank reported that the use of bilingual cord 
blood collectors combined with a targeted public relations effort that 
included radio advertising and a telethon decreased their refusal rate 
among the predominantly Spanish-speaking patient population at one 
hospital from 25 percent to 2 percent within a 48-hour period. 

While a few of the banks reported challenges related to the 
willingness of mothers from racial and ethnic groups to donate cord 
blood, most banks reported that certain characteristics of the cord 
blood collected from various racial groups present challenges to 
banking units that meet HRSA standards for inclusion in the NCBI. 
Specifically, four banks said issues of medical mistrust, including 
concern about how units may be used for research, could present a 
barrier to increasing the number of donors from certain groups. Seven 
of the banks reported that the cord blood they collected from certain 
groups, such as African American donors, has a lower volume and total 
cell count especially when compared to units collected from Caucasian 
donors.[Footnote 41] 

Of the seven banks that reported differences in collections from 
African Americans compared to others, two of the banks reported 
collecting more units from African American donors in order to collect 
one unit that can meet their banking standards relative to the number 
of units collected and banked from Caucasian donors.[Footnote 42] In 
addition, some banks use different volume or cell count thresholds 
when deciding whether to process cord blood collected from different 
racial and ethnic groups. One cord blood bank reported that it was 
able to establish a higher volume threshold to process cord blood from 
Caucasian donors than cord blood from African American donors because 
it is easier to collect large-volume units from Caucasian donors. For 
this bank, cord blood collected from Caucasian donors must contain at 
least 80 milliliters to be processed further, while cord blood 
collected from African American donors must contain at least 60 
milliliters of blood. Another bank reported that it raised the cell 
count threshold for units from Caucasian donors to 1.25 billion cells 
while holding the cell count threshold for units from African American 
donors at 900 million cells, while for a second bank its cell count 
threshold to process cord blood from Caucasian donors is 1.5 billion 
and 1.1 billion cells for other groups. According to some of the 
banks, this allows them to add cord blood units with higher cell 
counts, while increasing the number of units from African American 
donors in the inventory. While some banks reported difficulty in 
collecting and banking cord blood units with at least 900 million 
cells from African Americans, the median cell count of such units in 
NMDP's registry is 1.05 billion cells per unit. 

Those banks whose HRSA contracts were effective September 2010 are 
paid more for cord blood units collected from some minority groups who 
have historically had difficulty finding a cord blood or adult donor 
match.[Footnote 43] HRSA identifies alternative ways federal funds 
could be distributed to cord blood banks, in part to encourage the 
collection of diverse cord blood units, in its Interim Report on How 
Federal Funds are Distributed to Cord Blood Banks Participating in the 
National Cord Blood Inventory, which was provided to Congress on 
August 11, 2011. The report describes options for modifying the 
existing methods for distributing funds to cord blood banks, including 
providing a small amount of up-front funding to cord blood banks to 
defray start-up costs associated with initiating collections at new 
sites, providing payment for cord blood units collected remotely at 
hospitals in which the cord blood bank does not have a written 
agreement, or providing higher per unit reimbursement rates for cord 
blood units contracted by HRSA. The report notes that specific 
recommendations relating to NCBI funding will be included in HHS' next 
annual Report to Congress on stem cell issues. 

Remote Collection Is under Consideration for Increasing Cord Blood 
Units in the NCBI: 

Another potential approach for increasing the NCBI is to use remote 
collections. Remote collections involve sending a cord blood 
collection kit to a mother who plans to deliver her child at a site 
that does not have a written agreement with a public cord blood bank 
to routinely allow collections. The kit is then used by the mother's 
physician or midwife to collect the cord blood unit, which is then 
transported to the sponsoring cord blood bank. Currently, cord blood 
units collected remotely cannot be added to the NCBI because HRSA 
requires banks to have a written agreement with the collection site in 
order for units collected at the site to be included in the NCBI. 
Additionally, HRSA officials have said that they are uncertain about 
whether these units will meet FDA requirements for licensure. 

HRSA, through a contract with NMDP, has begun a pilot program with 
three of its contracted cord blood banks to remotely collect and bank 
500 cord blood units to determine whether cord blood donation using a 
kit-based model can increase the opportunities for public cord blood 
donation. As of March 2011, the three banks had collected 758 units. 
Of the 758 units, 68 had been banked--that is, processed and stored; 
the major reasons that units were discarded and not banked were units 
arriving at the lab after the allowed time for processing, low volume 
of cord blood collected, and required labels or documents associated 
with units being missing. 

Two of the three banks participating in the HRSA pilot identified some 
practices to address challenges identified during the pilot. Some of 
the lessons learned by one cord blood bank included (1) only 
initiating remote collections with mothers who start the process no 
later than 35 weeks gestation;[Footnote 44] (2) screening mothers for 
eligibility before sending out a collection kit; and (3) obtaining the 
doctors' agreement to participate and complete training on cord blood 
collection. Another bank reported working to develop a web-based 
training program targeting the physician collectors participating in 
remote collections that emphasizes the importance of collecting a 
large-volume cord blood unit. This pilot is scheduled to end September 
2011 and the results will be analyzed by HRSA and NMDP at that time. 

Increase in Demand of U.S. Cord Blood Units Has Slowed and Could 
Challenge Banks' Efforts to Increase the NCBI: 

Worldwide demand for U.S. cord blood units has slowed compared to the 
demand that existed when the NCBI was created. According to a GAO 
analysis of data from the World Marrow Donor Association, worldwide 
sales of cord blood units by U.S. banks rose 13.6 percent between 2005 
and 2006 and 38.4 percent between 2006 and 2007. In contrast, sales 
rose only 0.2 percent between 2007 and 2008, 10.4 percent between 2008 
and 2009, and only 0.4 percent between 2009 and 2010. According to the 
Advisory Council and HRSA, the slowing increase in demand for cord 
blood units may reflect factors that affect the demand for cord blood 
specifically, or stem cells in general. These factors include the 
medical community's questions about what diseases are best treated 
using stem cell transplantation, coverage limitations by health 
insurers for stem cell transplants, and alternative types of treatment 
for blood-related cancers that stem cell transplants are used to 
treat. Because banks rely heavily on cord blood unit sales to finance 
their operations, slowdowns in demand could adversely affect the 
banks' ability to finance efforts to expand collections at current 
collection sites or to expand the number of sites. 

According to presentations at Advisory Council meetings, stem cell 
transplantation is an evolving area of medicine in which questions 
exist about the diseases that are best treated by blood stem cell 
transplantation or about treatment protocols. Questions related to the 
practice of stem cell transplantation that are still under active 
clinical investigation include criteria for stem cell source 
selection,[Footnote 45] patient pretransplant preparation regimens, 
and ways to treat acute and chronic graft versus host disease. In May 
2010, the Advisory Council recommended that the Secretary of HHS 
convene an expert panel to develop consensus regarding an evidence- 
based list of diagnoses for which stem cell transplantation is an 
accepted standard of care. The panel has been formed and is in the 
process of conducting its work. 

Insurance coverage for treatment for stem cell transplantation varies. 
According to an Advisory Council working group, coverage varies 
because the use of stem cell transplantation as an effective treatment 
against certain diseases is not well understood by physicians, the 
insurance industry, or the public. The working group found that public 
and private insurers may not cover blood stem cell transplantation and 
if they do, they may cover the procedure only under limited 
circumstances or may exclude ancillary costs such as costs associated 
with searching for a donor. For example, the Medicare program covers 
stem cell transplants from donors for the treatment of certain 
diseases, and, in some cases, only if the beneficiary receives the 
transplant as part of a clinical trial.[Footnote 46] 

Alternative treatments to cord blood transplantation may also affect 
the demand for cord blood. Alternative treatments can include 
chemotherapy or stem cell transplants from sources other than cord 
blood. According to HRSA, advances in a drug used in the treatment of 
some types of leukemia have been successful in achieving remission for 
some patients, who might otherwise have been treated with a 
transplant, thereby reducing the demand for cord blood units for this 
particular group. However, according to at least three banks, it is 
too early to know whether advances in other types of treatments will 
reduce the future demand for cord blood. 

Alternatively, other potential factors might increase the demand for 
cord blood. In 2010, a clinical researcher at the Fred Hutchinson 
Cancer Research Center successfully expanded the number of blood stem 
cells in cord blood units up to 164-fold. This could be beneficial 
because a higher number of stem cells in a cord blood unit could more 
quickly reconstitute a patient's immune system with new stem cells, 
thereby lowering the risk that a patient would acquire life-
threatening infections during this recovery period. Researchers are 
also examining other types of stem cells contained in cord blood for 
possible future clinical applications including tissue regeneration. 
If such advancements lead to future increases in demand, it would also 
increase banks' ability to finance their efforts to expand collections 
and more quickly reach the NCBI goal. 

Most Banks Have Adopted Practices to Reduce Costs, but Are Uncertain 
about the Effect of Regulations on Costs and Revenues: 

Most banks reported that they had adopted practices to reduce the 
costs of cord blood banking, but some expressed concern that one 
proposed practice could reduce the genetic diversity of the NCBI. Some 
banks also reported uncertainty about the effect of FDA regulations on 
costs and revenues. 

Banks Reported Practices to Lower Costs, but Also Concerns that One 
Practice Could Adversely Affect the Genetic Diversity of the NCBI: 

Banks reported using a variety of practices to reduce the costs or to 
improve the efficiency of some of the activities associated with cord 
blood banking. One cost-saving practice reported by 11 of the 13 banks 
we interviewed is to use an early screening process to identify units 
that do not meet the NCBI cell count threshold of 900 million cells or 
the bank's own volume or weight requirements before incurring the 
costs of processing these units. This practice of establishing a 
preprocessing threshold eliminates the costs of processing units 
unlikely to be reimbursed by HRSA or to be desirable for use in stem 
cell transplantation.[Footnote 47] Preprocessing thresholds reported 
by the banks ranged from 900 million to 1.5 billion cells.[Footnote 
48] Some of these banks reported lower thresholds for units from 
African American donors and other donor groups. 

However, a proposed practice could reduce the genetic diversity of 
collections, including those for the NCBI. A limited financial 
analysis of public cord blood banking conducted by NMDP in 2010 found 
that raising the preprocessing threshold for all public cord blood 
units to at least 1.25 billion cells would allow the cord blood 
banking industry (but not necessarily individual banks) to gain enough 
excess revenue within 2 years to cover their annual operating 
costs.[Footnote 49] According to NMDP's analysis, increasing the 
percentage of higher cell count cord blood units in the public 
inventory, including those units in the NCBI, would respond to the 
increasing demand for higher cell count cord blood units. However, 
some of the cord blood banks have expressed concerns about NMDP's 
analysis, including that the industry averages used did not adequately 
account for bank variations in overhead and operating costs, that the 
model's assumptions about future demand were too high, and that NMDP 
did not take into account the potential effect of raising the cell 
count threshold on some groups' access to transplants. An official 
from NMDP acknowledged that, at higher thresholds, banks would process 
fewer units, particularly in some minority populations, which could 
reduce the genetic diversity of cord blood inventories, including the 
NCBI. According to HRSA, the Center for International Blood and Marrow 
Transplant Research is currently analyzing whether matching cord blood 
across ethnicities is as effective as matching cord blood between 
donors and recipients of the same groups. 

Some banks reported other practices for reducing their costs by 
increasing collaboration with organizations that have activities that 
are related to those of the bank. 

* To lower the cost of transportation, two banks rely on their local 
community blood bank to transport cord blood units collected at 
regional hospitals. 

* To lower its costs of donor recruitment and ongoing staff support to 
collection sites, one bank has developed partnerships with two 
nonprofit organizations dedicated to increasing patients' access to 
cord blood transplants. The two organizations have assumed some of the 
responsibilities normally assigned to bank staff, including monitoring 
collection activity at the site, ensuring an adequate supply of 
collection kits, and answering questions from site staff about cord 
blood collection. One of the organizations also pays for the 
collection kits at a collection site. 

* To lower the per unit cost of processing and storing cord blood 
units, two banks reported that they also process and store units for 
companies that market cord blood collection to expectant mothers for 
future use by the baby or other family members. 

* To lower the bank's costs of donor recruitment, one bank reported 
that it has entered into an arrangement with a neighboring state. The 
state is paying for staff to screen potential donor mothers and to 
obtain their informed consent, to pack and transport cord blood 
collected by physicians, and to administratively support the program. 
Upon receipt of the cord blood, the bank will then process and store 
the units. If a unit is sold for transplant, the bank will share the 
revenue with the state. 

In other efforts to reduce costs, one bank shifted recruiters' time 
that was spent obtaining informed consent from nonhospital settings to 
the hospital. Initially, bank staff obtained consent from potential 
donor mothers at clinics, health fairs, and birthing classes weeks and 
months prior to delivery. However, the bank noticed that many of these 
women, upon arrival at the hospital to deliver their babies, forgot 
their paperwork or did not inform the hospital staff of their desire 
to donate. To increase the effectiveness of the staff's efforts, the 
bank shifted the informed consent process to the hospital where the 
time spent in this process could ensure a greater number of mothers 
actually donating. Finally, to improve the efficiency of processing 
cord blood, two banks reported moving from manual to automated cord 
blood processing systems. According to one of the banks, the new 
system will allow the bank to increase the number of units processed 
threefold without changing the number of laboratory technicians. 

Some Banks Reported Uncertainty about the Effect of Complying with FDA 
Licensure Regulations on Costs and Revenues: 

Five of the 13 banks reported that their efforts to apply for FDA 
licensure have already increased their costs or noted that the total 
cost burden of operating as an FDA licensed bank is unclear. For 
example, two banks reported having to hire external consultants or 
reorganize staff duties to complete the application for licensure. Two 
banks reported that they have already incurred significant 
expenditures to make building renovations, buy new equipment, or hire 
additional staff in attempts to comply with FDA regulations. 

Further, banks reported uncertainty in how to meet some of FDA's 
regulatory and administrative requirements for licensure, which could 
result in increased expenditures to meet these requirements. Nine of 
the 13 banks reported that these concerns related to whether the 
spaces and equipment currently used by banks to collect and process 
cord blood will satisfy FDA licensure requirements or whether the 
banks will lose collection sites if licensure requirements force 
collection sites to register with the FDA. Some banks questioned 
whether FDA would require a "clean room" for processing units, which 
not all banks currently have. Banks also expressed concern that 
collection sites will no longer want to participate in public cord 
blood collection if FDA requires the sites to register with FDA. 
According to FDA officials, establishments that manufacture certain 
products, which include cord blood, are required to register and list 
their products with the FDA.[Footnote 50] These establishments are 
subject to FDA inspection. Some banks are concerned about the 
additional burdens that this will impose. If banks lose collection 
sites because of concerns about possible FDA inspection, the banks 
would be subject to the additional costs of adding new sites, which 
would include training site staff, providing collection materials, and 
transporting the units from the site to the bank. However, FDA 
officials told GAO in a July 2011 interview that they are taking the 
approach that neither individuals nor hospitals that have agreements 
with banks to collect cord blood will be required to register 
separately with FDA. FDA officials said that such entities are 
required to comply with product requirements applicable to their 
collecting activities, and the cord blood bank is responsible for 
ensuring that these entities under contract with the bank comply with 
FDA regulations. 

FDA officials have said that the benefits of cord blood licensure 
include greater assurance among doctors and patients of the quality 
and efficacy of cord blood units. Additionally, with licensure, cord 
blood banks will be able to sell cord blood units without IND pricing 
restrictions. However, some banks also reported that they were 
uncertain whether potential increased revenue from licensed units will 
offset their costs. In addition, the Advisory Council has expressed 
concerns about the potential for FDA's licensure requirements to 
result in increased cost and decreased availability of public cord 
blood units without necessarily increasing the safety, stability, 
potency, or purity of the units. In November 2010, the Advisory 
Council recommended that the FDA meet with the banks applying for 
licensure to share and resolve specific concerns regarding licensure. 
FDA officials have been meeting individually with cord blood banks to 
discuss the specifics of each bank's licensure application and 
circumstances. While FDA officials have stated that they could not 
confirm, for example, that a certain facility design would be 
acceptable in all situations, they said that they could provide 
clarification of the manufacturing regulations for individual banks. 

Concluding Observations: 

Since 2005, HRSA has contracted for about 30 percent of the minimum 
statutory goal of at least 150,000 new units of high quality cord 
blood. While not yet meeting the statutory goal, the NCBI has 
increased the number of high quality, genetically diverse units 
available for transplantation in the United States. This inventory, 
along with other sources of cord blood stem cells, contributed to 
making nearly 135,000 U.S. cord blood units available in the NMDP 
registry. In 2010, about 1,200 patients had received cord blood 
transplants from units identified in the registry. However, although 
there are nearly 135,000 cord blood units in the registry, members of 
certain racial and ethnic groups will continue to have more difficulty 
finding a closely matched unit than other groups. This disparity would 
be reduced, though not completely eliminated, if the number of units 
available were expanded. 

Cord blood banks contracting with HRSA are taking steps to increase 
collections and make their operations more efficient and cost- 
effective, but continuing advances in medical science make it 
difficult to predict future demand for cord blood stem cells and the 
resulting level of collections that should be undertaken. Based on 
current science, cord blood appears to present some advantages over 
other stem cell sources--such as bone marrow--both in terms of health 
benefits and in being already collected and readily available for use 
when listed in public registries. These advantages may increase in 
future years if factors that could increase the quality of cord blood 
units are realized or they may diminish if alternatives to cord blood 
are developed or improved. 

Agency Comments: 

In commenting on a draft of this report, HHS provided additional 
information concerning several content areas of the report, including 
demand for U.S. cord blood units, HRSA's pilot project for remote 
collections of cord blood units, and efforts to increase the diversity 
of the cord blood units collected for the NCBI. We included that 
additional information where appropriate. HHS's comments are printed 
in appendix I. HHS also provided technical comments, which we 
incorporated as appropriate. 

We are sending copies of this report to the Secretary of Health and 
Human Services and other interested parties. In addition, the report 
will be available at no charge on GAO's website at [hyperlink, 
http://www.gao.gov]. 

If you or your staff have any questions about this report, please 
contact me at (202) 512-7114 or at crossem@gao.gov. Contact points for 
our Office of Congressional Relations and Office of Public Affairs can 
be found on the last page of this report. Other major contributors to 
this report are listed in appendix II. 

Signed by: 

Marcia Crosse: 
Director, Health Care: 

List of Committees: 

The Honorable Tom Harkin: 
Chairman: 
The Honorable Michael Enzi: 
Ranking Member: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Fred Upton: 
Chairman: 
The Honorable Henry Waxman: 
Ranking Member: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Tom Harkin: 
Chairman: 
The Honorable Richard Shelby: 
Ranking Member: 
Subcommittee on Labor, Health and Human Services, Education, and 
Related Agencies: 
Committee on Appropriations: 
United States Senate: 

The Honorable Denny Rehberg: 
Chairman: 
The Honorable Rosa DeLauro: 
Ranking Member: 
Subcommittee on Labor, Health and Human Services, Education, and 
Related Agencies: 
Committee on Appropriations: 
House of Representatives: 

[End of section] 

Appendix I: Comments from the Department of Health and Human Services: 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

September 27, 2011: 

Marcia Crosse, Director: 
Health Care: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Crosse: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) draft report entitled, "National Cord Blood Inventory: Practices 
for Increasing Availability for Transplants and Related Challenges" 
(GAO-12-23). 

The Department appreciates the opportunity to review this report 
before its publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

[End of letter] 

General Comments Of The Department Of Health And Human Services (HHS) TO
The Government Accountability Office's Draft Report Entitled: 
"National Cord Blood Inventory: Practices For Increasing Availability 
For Transplants And Related Challenges" (GAO-12-23): 

Page 7 - HRSA requests that the following sentence be added to the 
paragraph: "Similarly, 30 percent of NCBI units are from Hispanic 
donors versus 16 percent for non-NCBI CBUs and 13 percent for adult 
donors." This will ensure that a comparison is provided for Hispanic 
donors. 

Page 12 - last sentence under the header HRSA Pilot Project for Remote 
Collections. HRSA requests that the report note why units from remote 
collections are not included in the NCBI. Please add the following 
sentence: "Banks would need to obtain licensure from FDA for CBU 
collected using this method. HRSA has expressed its willingness to re-
visit the exclusion of such units from the NCBI once licensure is 
achieved." 

Page 13, line 3 - HRSA requests that the agency's rationale for 
differential reimbursement rates across different racial/ethnic groups 
be added here. HRSA requests that the challenges associated with 
obtaining units of qualifying cell counts from certain groups and 
HRSA's goal of continuing to grow the inventory for patients who have 
historically had a difficult time finding an adequate adult donor or 
cord blood unit for transplantation be noted here as this section 
addresses the difficulty, quality, and costs of the collection and use 
of cord blood for minority and underserved populations (HRSA's payment 
for units collected from minority groups is addressed again on page 
26). 

Page 18, paragraph one, bullet #1 - HRSA requests that the bullet note 
that the NMDP provided cord blood banks with information on U.S. 
hospitals that are located in metropolitan areas with large African-
American and Asian populations and where there are large numbers of 
births. 

Page 20, last sentence - HRSA requests that GAO underscore the lower 
nucleated cell counts between African-American donors and other racial 
groups and ethnicities by stating that no banks reported equivalent 
cell counts between African-American donors and other groups.
Page 23 - HRSA requests that this section, Increase in Demand of Cord 
Blood Units Has Slowed and Could Challenge Banks' Efforts to Increase 
the NCBI, be modified. 

* HRSA requests that the section start by addressing the U.S. 
experience and only mentioning briefly worldwide demand. The NCBI and 
C.W. Bill Young Cell Transplantation Program are intended to increase 
access to transplant for U.S. patients. GAO's emphasis on 
decreased/slowed demand for cord blood worldwide may mislead readers 
about the U.S. issues. In fact, NMDP-facilitated cord blood 
transplants and CBU shipments continue to increase. Additionally, cord 
blood continues to play a critical role in minority transplants 
facilitated by the NMDP. Cord blood transplants are increasing in the 
U.S., though less rapidly than in years past. Please note the cost 
pressures on cord blood transplants, as well as cord blood banking, as 
factors impacting the decreased rate of growth in cord blood 
transplants. 

* CBU shipments continue to increase significantly as more cord blood 
transplants that use multiple cord blood units are performed for 
adults. Overall, NMDP cord blood transplants are increasing. 

Page 30, paragraph 1, last two sentences under the section, Concluding 
Observations - Although the statement is true, it could be read to 
imply additional CBU would make no difference. 

HRSA requests changing the last sentence to read: "This disparity 
would be reduced, though not completely eliminated, if the number of 
available units were expanded." 

[End of section] 

Appendix II: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Marcia Crosse, (202) 512-7114 or crossem@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Karen Doran, Assistant 
Director; Carrie Davidson; Cathleen Hamann; Toni Harrison; Natalie 
Herzog; and Monica Perez-Nelson made key contributions to this report. 

[End of section] 

Footnotes: 

[1] For purposes of this report, stem cells refer to blood-forming 
stem cells. 

[2] A cord blood unit available for transplant refers to the stem 
cells isolated from the blood extracted from a single umbilical cord 
and the placenta. 

[3] The Institute of Medicine report estimated that there were more 
than 44,000 cord blood units available in the United States, but 
estimated that not all publicly available cord blood units would meet 
clinical standards for transplant. See E. A. Meyer, K. Hanna, and K. 
Gebbie, (Eds.). Cord Blood: Establishing a National Hematopoietic Stem 
Cell Bank Program (Washington, D.C.: National Academies Press, 2005). 

[4] Pub. L. No. 109-129, 119 Stat. 2550 (Dec. 20, 2005). 

[5] Prior to 2005, cord blood was already being banked for public use 
in the United States. A 2005 Institute of Medicine report estimated 
that at least 100,000 new, high quality units should be made available 
to provide as many potential recipients with a high probability of 
receiving an effective cord blood unit. 

[6] Pub. L. No. 111-264, 124 Stat. 2789 (Oct. 8, 2010). 

[7] The Reauthorization Act also authorized $112 million to fund cord 
blood unit collections through 2015. 

[8] HRSA contracts for cord blood units using the following racial and 
ethnic categories: American Indian/Alaskan Native, Black/African 
American, Asian, Native Hawaiian/Pacific Islander, White/Caucasian 
(non-Hispanic), White/Caucasian (Hispanic), and Multi-race. 

[9] From 2006 through the end of fiscal year 2010, HRSA had obligated 
$56.4 million for the collection of units for the NCBI. 

[10] The Cord Blood Coordinating Center is a component of the C.W. 
Bill Young Cell Transplantation Program, which was established by the 
Stem Cell Act. The C.W. Bill Young Cell Transplantation Program was 
designed to help patients who need a stem cell transplant by making 
information about bone marrow and cord blood transplantation 
available, providing efficient and effective processes for identifying 
sources of stem cells through a single electronic system, increasing 
the numbers of stem cell donors and units that are available, and 
expanding research to improve patient outcomes. 

[11] One of the requirements of the contract with HRSA for the NMDP 
requires the maintenance of a national registry of cord blood units, 
including units from the NCBI. Other requirements include working with 
cord blood banks to recruit cord blood donors and coordinating a 
network of organizations, including public cord blood banks and 
transplant centers, to work together to provide quality cord blood 
transplants. 

[12] The Advisory Council was established by the Stem Cell Act to 
advise, assist, consult with, and make recommendations to the 
Secretary of HHS on matters related to the activities of federal cell 
transplantation programs. 

[13] The outcome of a transplant also depends on common determinants 
of treatment success, such as patient age and disease severity. 

[14] An antigen is a protein found on the outside of most cells in the 
body that induces the formation of antibodies. There are a number of 
antigens in the human body, and HLA are a set of these. 

[15] Graft versus host disease occurs when donor cells attack the 
recipient's normal tissues after transplant, and can lead to organ 
damage. 

[16] NMDP's registry, which lists adult bone marrow donors and cord 
blood units, is known as Be The Match®. 

[17] Adults who are willing to donate stem cells from their bone 
marrow or bloodstream are volunteers and must be between 18 and 60 
years old. Cord blood donation is also voluntary. 

[18] As of May 31, 2011, NMDP's registry also included 22,363 cord 
blood units and 2,797,958 adult donors from seven other countries. 
Based on GAO analysis of the most recent data from the World Marrow 
Donor Association, as of January 1, 2010, approximately 63,000 U.S. 
public cord blood units were not part of NMDP's registry. Transplant 
centers can use NMDP to search all of these other units for a match 
using NMDP's search process. 

[19] In 2010, NMDP modeled the costs and benefits of cord blood 
inventory growth and estimated probabilities of a match for patients 
assuming cord blood from NMDP's registry as the only source of stem 
cells. The model was developed using the 94,199 cord blood units from 
the United States and four other countries in the NMDP registry as of 
December 31, 2008, and provided a 63 percent or better probability of 
finding a close match for all racial and ethnic groups. According to 
the model, an inventory of at least 1 million cord blood units would 
be required for a 90 percent or better probability of finding a unit 
that is a close match with a minimum treatment dose for most racial 
and ethnic groups. This model also showed that even with an inventory 
of 10 million units, the probability of finding such a unit for 
certain minority groups would remain below 90 percent. Thus, while 
adding a significant number of units to this inventory could increase 
the likelihood of finding more closely matched units for 
transplantation, it does not guarantee that all patients needing a 
transplant will find an appropriate cord blood match. 

[20] NMDP's search process links users to an international repository 
of data from 65 stem cell donor registries and 47 cord blood banks 
that is maintained by Bone Marrow Donors Worldwide. As of August 15, 
2011, Bone Marrow Donors Worldwide had matching information on 17.8 
million adult donors and 492,000 cord blood units worldwide. 

[21] Based on GAO analysis of data from the World Marrow Donor 
Association and NMDP, in 2010, NMDP facilitated 85 percent of the 
sales of cord blood units by U.S. cord blood banks in contrast to 33 
percent in 2005. Where NMDP is not involved, the transaction is 
between another U.S. registry or a U.S. cord blood bank and the 
transplant center. With some exceptions, all of the sales facilitated 
by NMDP were of cord blood units identified through its registry. 

[22] The minimum number of blood stem cells for a therapeutic dose is 
estimated to be 25 million cells per kilogram of patient weight. 

[23] Thirteen other banks have contributed to the inventory of 
domestic cord blood units listed on the NMDP registry but 7 of the 13 
have stopped contributing new units, while the other 6 banks are still 
contributing units. 

[24] The Stem Cell Act requires banks to make units that are not 
appropriate for clinical use available for research. 

[25] The active phase of labor begins after the cervix has dilated to 
a certain diameter and ends when it becomes fully dilated and the 
presenting part of the baby descends into the mid-pelvis. 

[26] Since the cord blood unit will be used for transplant or in 
clinical research, potential donor mothers must give informed consent 
consistent with federal regulations. No identifying information about 
the mother or the baby is provided to the transplant centers or to 
researchers. Informed consent must be obtained prior to initiation of 
the collection process. Some of the eligibility screening activities 
may be completed after the baby has been delivered. 

[27] There are 6 other U.S. cord blood banks that contribute cord 
blood units to the NMDP registry, but do not currently have HRSA 
contracts. In total, there are 175 hospital collection sites for 
public cord blood donation in 27 states. 

[28] Freezing consists of transferring the cells into bags suitable 
for freezing in liquid or vapor nitrogen and beginning a controlled 
cooling of the cells. Once frozen, the stem cells are placed into a 
special freezer for future retrieval. 

[29] If the bank has met its HRSA contract goals, it may continue to 
collect cord blood units and register them on the NMDP registry or 
other registries. 

[30] The Stem Cell Act required HRSA to ensure that no funds would be 
obligated under the contracts after the earlier of 3 years after the 
contracts were entered into or September 30, 2010. The Stem Cell Act 
provided for extensions of funding beyond the 3-year limit under 
certain conditions. 

[31] At the May 2011 Advisory Council meeting, a council member 
presented a summary of research on expiration dates that showed no 
signs of deterioration of a frozen cord blood unit that is used within 
10 years of collection. At a prior meeting, a cord bank official noted 
that the official's bank has units that have been stable for 18 years. 

[32] The Reauthorization Act also provided for extensions in funding 
beyond the 5 years under a slightly different set of conditions than 
those specified in the 2005 act. 

[33] HRSA also requires that cord blood banks and cord blood units 
meet all applicable FDA requirements, adhere to selected requirements 
set forth by NMDP, and that the bank have and maintain cord blood 
accreditation from either one of the two cord blood banking 
accrediting bodies--the American Association of Blood Banks or the 
Foundation for the Accreditation of Cellular Therapy. 

[34] The average payment is based on the total number of dollars 
reimbursed to banks contributing to the NCBI divided by the total 
number of units on invoices submitted to HRSA between March 2007 and 
June 6, 2011. 

[35] The analysis was based on the costs reported to NMDP by four 
banks. 

[36] For the purposes of our report, public cord blood banking refers 
to banking cord blood units for use by the general public. 

[37] This applies to cord blood units that have been minimally 
manipulated. FDA regulations further define "minimal manipulation" for 
structural tissue as "processing that does not alter the original 
relevant characteristics of the tissue relating to the tissue's 
utility for reconstruction, repair, or replacement." 21 CFR 1271.3 
(2011). 

[38] An investigational new drug is a drug that has not been approved 
for general use by the FDA but is under investigation in clinical 
trials to evaluate its safety and efficacy by clinical investigators 
using patients who have consented to participate. The application that 
is submitted and approved by FDA for a drug to be used as an 
investigational new drug is referred to as an IND. 

[39] On January 20, 1998, FDA issued a notice in the Federal Register 
stating that it was requesting comments on the development of product 
standards and physical facility and processing controls for certain 
products, including cord blood. To allow sufficient time for the 
development of data and standards for these products, the notice also 
announced the agency's intention to phase in implementation of IND and 
license application requirements for these products. 63 Fed. Reg. 2985 
(Jan. 20, 1998). In 2007, FDA published draft guidance regarding these 
standards and processing controls and in 2009 FDA published the final 
guidance. In the October 20, 2009, Federal Register notice announcing 
the final guidance, FDA announced that the phase-in implementation 
period would end October 20, 2011. 74 Fed. Reg. 53753 (Oct. 20, 2009). 

[40] Private cord blood banks store cord blood units only for use by a 
family member. These banks generally charge a fee for banking of the 
cord blood and leave any decisions regarding the use of the unit to 
the donor or the donor's family. 

[41] A 2007 study conducted by one of the banks comparing the 
characteristics of 556 stored units from African American and 
Caucasian donors showed that the median total nucleated cells for 
African American and Caucasian units was 956.5 million and 1.0367 
billion, respectively. This difference was found to be statistically 
significant. See J. Wofford, J. Kemp, D. Regan and M. Creer, 
"Ethnically mismatched cord blood transplants in African Americans: 
the Saint Louis Cord Blood Bank experience," Cytotherapy, vol. 9, no. 
7 (2007),660-6. 

[42] At the May 2011 Advisory Council meeting, a work group's report 
on the impact of raising the cell count standards for inclusion in the 
NCBI noted that if the cell count threshold for African American units 
was raised from 900 million cells to 1.25 billion cells, the 
percentage of units collected and then banked from this group would 
decrease from between 20 to 24 percent to 5 percent or less. 

[43] In the summer of 2009, HRSA extended several of the NCBI 
contracts and included this same differential reimbursement for cord 
blood units collected from minority donors. 

[44] Gestation is the period of time between conception and birth, and 
is measured in weeks. A normal pregnancy can range from 38 to 42 weeks. 

[45] Stem cell sources include bone marrow and the bloodstream from 
the patient, as well as donors, and cord blood. 

[46] This is a description of Medicare's national coverage policy. All 
other indications for stem cell transplantation not otherwise noted by 
Medicare as covered or noncovered nationally remain at local Medicare 
administrative contractor discretion. 

[47] In 2010, 82 percent of all NMDP cord blood units chosen for 
transplantation had cell counts equal to or greater than 1.25 billion 
cells. 

[48] The 11 banks reported preprocessing thresholds based on cell 
count only (6 banks), both cell count and volume (3 banks), volume 
only (1 bank), and weight only (1 bank). 

[49] NMDP's analysis included HRSA reimbursement as one of the 
industry's revenue sources. 

[50] These products include human cells, tissues, or cellular-and 
tissue-based products. 

[End of section] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each 
weekday, GAO posts newly released reports, testimony, and 
correspondence on its Web site. To have GAO e-mail you a list of newly 
posted products every afternoon, go to [hyperlink, http://www.gao.gov] 
and select "E-mail Updates." 

Order by Phone: 

The price of each GAO publication reflects GAO’s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO’s Web site, 
[hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional 
information. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 

Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]: 
E-mail: fraudnet@gao.gov: 
Automated answering system: (800) 424-5454 or (202) 512-7470: 

Congressional Relations: 

Ralph Dawn, Managing Director, dawnr@gao.gov: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, D.C. 20548: 

Public Affairs: 

Chuck Young, Managing Director, youngc1@gao.gov: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, D.C. 20548: