December 15-16, 2008

ACBSCT recommends that the Secretary direct the Centers for Medicare & Medicaid Services (CMS), as a high priority, to develop an appropriate strategy for the National Coverage Determination of allogeneic stem cell transplantation as therapy for the Myelodysplastic Syndromes based on the recent evidence-based review of the literature.

The rationale for this recommendation is:

• The Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia (AML) are life threatening blood disorders that are often part of the same disease process continuum.
• There is strong evidence for the benefit of allogeneic stem cell transplantation in the treatment of AML.
• There is strong evidence for the benefit of allogeneic stem cell transplantation for MDS in patients less than 65 years, and growing evidence in patients greater than 65 years.
• There is also evidence that co-morbidities may have a greater impact than age on allogeniec stem cell transplantation outcomes in older adults.

ACBSCT recommends to the Secretary that the Health Resources and Services Administration’s (HRSA) C.W. Bill Young Cell Transplantation Program (Program) implement the following policies for protecting the privacy and confidentiality of cord blood donors donating umbilical cord blood units to the Program. Public Law 109-129 (42 U.S.C. 274k; Section 379 of the Public Health Service Act) defines a qualified cord blood bank participating in the National Cord Blood Inventory (NCBI) as having the following confidentiality requirements: 1) a system to confidentially maintain a linkage between a cord blood unit and a maternal donor; and 2) a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with existing Federal and State law.

This recommendation is presented in two parts: cord blood unit linkage requirement and disclosure information.

The purpose of this recommendation is to specify the policies needed to establish a system of strict confidentiality to protect the identity and privacy of cord blood donors and recipients.  The “donor” refers to the baby whose cord blood is being considered for donation or who has donated a cord blood. The baby’s mother is the person who provides legal consent for donation on behalf of the baby. Typically, any continued contact with the donor’s family will be with the donor’s mother, but there may be instances when contact is with a legal guardian other than the mother. “Recipient” and “patient” are used interchangeably to refer to the person receiving the cord blood unit for transplantation.

The purpose of this recommendation is to specify the policies needed to establish a system of strict confidentiality to protect the identity and privacy of cord blood donors and recipients.  The “donor” refers to the baby whose cord blood is being considered for donation or who has donated a cord blood. The baby’s mother is the person who provides legal consent for donation on behalf of the baby. Typically, any continued contact with the donor’s family will be with the donor’s mother, but there may be instances when contact is with a legal guardian other than the mother. “Recipient” and “patient” are used interchangeably to refer to the person receiving the cord blood unit for transplantation.

1. Cord Blood Unit Linkage Requirement:  A link between the identity of the donor and the cord blood unit is required. In order for information to be exchanged between the donor mother and the cord blood bank regarding test results from the cord blood unit, as well as information about the continued health status donor, a link is needed between the donor’s identity and contact information and the cord blood bank. Maintaining a link between the identity of the donor and the cord blood unit is required by regulatory agencies and is part of good tissue practices.
   1. Specific permission for maintaining demographic medical information must be obtained from the donor and the potential risks of breaches of confidentiality must be disclosed.
   2. The donor mother should be informed if abnormal conditions are detected in the cord blood when tested. Medical information should be transmitted to the donor’s physician, so that the donor mother can be appropriately informed. The cord blood bank should attempt to notify the donor mother to contact the physician for interpretation of test results.
   3. The donor mother should be asked to report any major changes in the health status of the donor. Procedures for how the donor mother should contact the bank need to be made clear. The donor mother should be given materials that make it easy for them to contact the cord blood bank (e.g., follow-up post cards, cards with telephone numbers and addresses, etc.).
   4. There are no specified limits as to how frequently or how long a donor mother can be contacted.
   5. Records must be retained for a minimum of 10 years after the cord blood unit is used or discarded, consistent with AABB standards.
   6. All communications and records must be stored in such a way as to ensure the strictest confidentiality. Records must be protected from accidental or unauthorized access, destruction, or modification through the use of physical security methods (e.g., consent forms, data forms, and servers must stored in locked cabinets or in rooms to which only a small set of authorized employees have access), data encryption and use of passwords, and network security through the use of firewalls and other security methods.
2. Disclosure of information:  Three categories of disclosure are recommended:  (a) information related to the cord blood unit that routinely should be disclosed to the recipient; (b) information related to the cord blood unit that is not recommended for disclosure to the recipient or donor; and (c) information related to the cord blood unit that must never be disclosed to the recipient.
   1. Information related to the cord blood unit that routinely should be disclosed to the recipient.
      1. The following information is considered appropriate to disclose to the patient, as it does not present a risk of disclosure of identity of the cord blood donor: Year the cord blood unit was collected, the sex of the donor, the blood group and Rh antigens (ABO/Rh type), the total nucleated cell (TNC) count of the cord blood unit, and the Human Leukocyte Antigen (HLA) level and location of match/mismatch of the cord blood unit.
      2. Recipients should be informed and counseled about positive risk-related responses on the maternal health history questionnaire, positive infectious disease marker (IDM) test results and genetic hemoglobin abnormalities, if known, and allele level typing if requested by recipient.
   2. Information related to the cord blood unit that is not recommended for disclosure to the recipient or donor.
      1. The following information should not be disclosed to recipients: the name of the cord blood bank from which the cord blood unit was procured, the unique identification number of the cord blood bank. This is of particular concern in the case of cord banks in small, contained community settings, for which the year and name of the bank may be enough information to compromise the identity of the donor. For all settings, it is very strongly advised that the day and month that the cord blood unit was collected not be disclosed to recipients. Whether the unit is domestic or foreign should not be disclosed nor should the race/ethnicity of the donor. Information related to the cord blood unit that is not recommended for disclosure to the donor.
      2. The following information is not recommended for disclosure to the donor or donor mother: the status of donated cord blood unit; that is, whether the unit was discarded, collected, banked, used for research, or used for transplant. However, it is recognized that some Institutional Review Boards require that cord blood banks inform the mothers if the unit was discarded.
   3. Information related to the cord blood unit that must never be disclosed to the recipient or donor.
      1. Information related to the cord blood unit that must never be disclosed to the recipient.  The identity of and contact information for the donor must not be revealed to the recipient. Recipients wishing to show gratitude to their donors should be encouraged to write a general letter of thanks to the National Marrow Donor Program, the Health Resources and Services Administration, or other appropriate organization, which could then publicly post the letter on a website or in printed materials.
      2. Information related to the cord blood unit that must never be disclosed to donors. The recipient’s identity and contact information must never be revealed to the donor or donor family.

*In a clinically appropriate manner or in great detail upon patient request