CIGNA HEALTHCARE COVERAGE POSITION

CIGNA HEALTHCARE COVERAGE POSITION Subject Umbilical Cord Blood Banking Table of Contents Coverage Position... 1 General Background... 1 Coding/Billing Information... 3 References... 3 Revised Date... 6/15/2007 Original Effective Date... 7/15/2006 Coverage Position Number... 0466 Hyperlink to Related Coverage Positions Transplant Donor Charges INSTRUCTIONS FOR USE Coverage Positions are intended to supplement certain standard CIGNA HealthCare benefit plans. Please note, the terms of a participant s particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Positions are based. For example, a participant s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Position. In the event of a conflict, a participant s benefit plan document always supercedes the information in the Coverage Positions. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable group benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Positions and; 4) the specific facts of the particular situation. Coverage Positions relate exclusively to the administration of health benefit plans. Coverage Positions are not recommendations for treatment and should never be used as treatment guidelines. 2007 CIGNA Health Corporation Coverage Position CIGNA HealthCare covers collection and storage costs associated with the banking of umbilical cord blood as medically necessary when hematopoietic transplantation using cord blood cells is planned within the next 36 months for a member-recipient. In the absence of a planned or expected hematopoietic transplantation where cord blood cells will be required, CIGNA HealthCare does not cover collection and storage costs associated with the banking of umbilical cord blood because it is considered not medically necessary. General Background The use of umbilical cord blood as a source of stem cells for hematopoietic transplantation was first proposed by Edward Boyse in 1983. Until that time, blood which remained in the umbilical cord and placenta after delivery was routinely discarded as medical waste. Gluckman et al. performed the first related umbilical cord transplant in a child with Fanconi anemia in 1988. To date, over 7000 umbilical cord transplants have taken place worldwide, surpassing the number of peripheral blood stem-cell transplants performed. Cord blood is now known to contain both hematopoietic stem cells and pluripotent mesenchymal cells, which may be used in the treatment of leukemias, hemoglobinopathies, and inborn errors of metabolism. More recently isolation of mesenchymal cells found in umbilical cord blood has been used in research for regenerative treatment of disease, primarily neurologic disorders (Moise, 2005). Umbilical cord blood transplantation is established practice in the pediatric setting. Advantages to the use of umbilical cord blood compared to peripheral blood or bone marrow include a limitless supply, the units are available on short notice, ethnic diversity is easier to achieve, painless collection of stem cells, higher proliferative capacity, and a lower rate of acute graft-versus-host disease. Page 1 of 5

Disadvantages include the inability to obtain additional donor cells, fewer total cells due to small volumes, slower engraftment and high up-front costs (Moise, 2005). Umbilical cord blood is effective as a source of hematopoietic cells for transplantation; compared with adult cells, they have immune naiveté because of their minimal previous exposure to antigens. As such, the cord blood cells have a reduced capacity to illicit an alloreactive response, and there is somewhat less likelihood of graft-versus-host disease. Although cord blood units have high concentrations of hematopoietic progenitor cells, they have relatively small volumes and fewer total cells. Very low cell doses can result in a higher risk of non-engraftment, especially in larger children and adults. Cord blood is collected at the time of delivery by one of two methods: in vivo or in vitro collection. In vivo collection is done while the placenta still remains in the uterus. Larger unit volumes and higher total nucleated cell counts may result with this method. Conversely, bacterial contamination may occur due to the proximity to the perineum. Additionally, in the case of cesarean section, in vivo collection may result in increased operative time and make removal of the uterus more difficult once collection has occurred. In vitro collection is usually performed by trained personnel outside of the delivery room. Macroscopic clot formation may occur with the prolonged handling times necessary for this type of collection. The collected umbilical cord blood is then sent to a specified blood bank for processing and storage. For most parents, cord blood donation is not an option because the number of locations served by registries is very limited. Use of cord blood as a source of hematopoietic stem cells has led to the establishment of cord blood banks worldwide. The American Association of Blood Banks (AABB) and the Foundation for Accreditation of Cellular Therapy (FACT-NETCORD) have created guidelines pertaining to collection, testing, processing and banking of umbilical cord blood for transplantation and provide the accreditation of banks. The banking of cord blood for private or public use is a controversial issue. Banks may be public, private or directed-donation banks. Currently, there are over 20 public and 24 private cord blood banks in the United States. Public banks involve allogeneic donation. Blood is collected from the general public in a manner similar to whole blood banking, specifically by women delivering healthy babies at term. The cells are stored in a general facility for public use. In 1991, the New York Blood Center established the first public blood bank for umbilical cord blood through funding provided by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Although most public banks receive start-up funding from the NIH, many of them struggle financially because the revenues gained from the sale of the units for transplantation are not sufficient to support the basic operations of a bank that is building inventory (Kurtzberg, 2005). In 2004, Health Resources and Services Administration (HRSA) division of the Department of Health and Human Services asked the Institute of Medicine (IOM) to make recommendations about the feasibility of establishing a national cord blood program. The IOM recommendations were released in 2005. Private cord blood banks were initially established for autologous use by a child who might develop a disease later in life. The premise is one of biological insurance for the potential need of stem cells; however, the likelihood of a child requiring a transplant with its own cord blood is small. More recently, private banks have promoted their services for collection and storage of cord blood for potential use by siblings and parents. Cord blood is collected in the case in which a sibling or parent is affected with a disorder in which cord blood transplantation may be beneficial. The type of disorder and the need for autologous cells versus allogeneic cells determines the actual potential for use of these cells (Moise, 2005). U.S. Food and Drug Administration (FDA) The FDA has passed Good Tissue Practice regulations in the Federal Register of 2001 which apply to human cellular and tissue products used for transplantation. These regulations lay the groundwork for standards for collection, storage, documentation and labeling, and cord blood banking operations, and require establishments supplying human cells, tissue, and cellular and tissue-based products to register and list their products with the FDA. Professional Societies/Organizations Page 2 of 5

The Institute of Medicine recommended that the U.S. Department of Health and Human Services should establish a new National Cord Blood Policy Board to set rules for the banking and use of lifesaving stem cells derived from donated umbilical cord blood (IOM, 2005). In an updated policy statement, the American Academy of Pediatrics (2007) stated that, Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use, because most conditions that might be helped by cord blood stem cells already exist in the infant s cord blood. In addition, Cord blood donation should be encouraged when the cord blood is stored in a bank for public use. The Guidelines further state that, Given the difficulty of making an accurate estimate of the need for autologous transplantation and the ready availability of allogeneic transplantation, private storage of cord blood as biologic insurance is unwise. In Europe, the practice of private cord banking has been banned by law in Italy since 2002. The Royal College of Obstetricians and Gynaecologists (2006) says, There is still insufficient evidence to recommend directed commercial cord blood collection and stem-cell storage in low-risk families. Likewise, the French National Consultative Ethics Committee s recommendation to decision makers is that they should encourage a considerable extension of cord blood public banks for essentially allogeneic purposes, rather than subscribing to the creation of private banks for strictly autologous purposes, the potential therapeutic usefulness of which, is, as of yet, in no way corroborated (Moise, 2005). Summary Umbilical cord blood is an appropriate source of hematopoietic stem cells for autologous or allogeneic stem-cell transplantation for the treatment of some leukemias, hemoglobinopathies, and inborn errors of metabolism. The potential need of a child to use its own cord blood for treatment is very small. Umbilical cord blood banking when there is no planned hematopoietic transplantation is not medically necessary. Umbilical cord blood collection and storage is medically necessary when an umbilical cord transplant has been approved and is planned. Coding/Billing Information Note: This list of codes may not be all-inclusive. Covered when medically necessary: CPT * Description 38207 Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage. HCPCS G0265 G0266 S2140 ICD-9-CM Diagnosis Description Cryopreservation, freezing and storage of cells for therapeutic use, each cell line Thawing and expansion of frozen cells for therapeutic use, each aliquot Cord blood harvesting for transplantation, allogeneic Description Multiple/varied *Current Procedural Terminology (CPT ) 2006 American Medical Association: Chicago, IL. References Page 3 of 5

1. American Academy of Pediatrics. Cord blood banking for potential future transplantation: subject review. Work Group on Cord Blood Banking. Pediatrics. 1999;104:116-118. 2. American Academy of Pediatrics Section on Hematology/Oncology; American Academy of Pediatrics Section on Allergy/Immunology; Lubin BH, Shearer WT. Cord blood banking for potential future transplantation. Pediatrics. 2007 Jan;119(1):165-70. 3. American Cancer Society. Banking on cord blood. Updated 1999 Jan 5. Accessed May 1, 2007. Available at URL address: http://www.cancer.org/docroot/nws/content/nws_1_1x_banking_on_cord_blood.asp 4. American Medical Association. Umbilical cord blood transplantation: current scientific understanding. Report 2 of the council on scientific affairs (A-03). 2003 June. Accessed May 1, 2007. Available at URL address: http://www.ama-assn.org/ama/pub/category/14516.html 5. Brunstein C, Wagner J. Umbilical cord blood transplantation and banking. Ann Rev Med.2006 Feb;57:403-417. 6. Carpenter RJ Jr. Commercial cord blood banking: public cord blood banking should be more widely adopted. BMJ. 2006 Oct 28;333(7574):919 7. Centers for Medicare and Medicaid Services (CMS)(website) Medicare coverage homepage. Updated Apr 25, 2005. Accessed May 1, 2007. Available at URL address: http://www.cms.hhs.gov/mcd/search.asp? 8. Coalition for responsible Cord Blood Banking. President signs bill establishing national umbilical cord blood program. 2005 Dec 20. Accessed May 1, 2007. Available at URL address: http://cordcoalition.nonprofitoffice.com/index.asp?type=b_pr&sec={17cb8500-af58-446f- 98F2-285A4BF4C311}&DE={90A4EB02-36CD-4EB7-A358-76832C15E989} 9. Hutchon David JR. Commercial cord blood banking: immediate cord clamping is not safe. BMJ. 2006 Oct 28;333(7574):919. 10. Keuhn BM. Pediatrics group recommends public cord blood banking. JAMA. 2007 Feb 14;297(6):576. 11. Kurtzberg J, Lyerty A, Sugarman J. Untying the Gordian knot: policies, practices and ethical issues related to banking of umbilical cord blood. J Clin Invest. 2005 Oct. 115(10):2592-7. 12. March of Dimes. Umbilical cord blood. Updated 2007 Jan. Accessed May 7, 2007. Available at URL address: http://search.marchofdimes.com/cgibin/msmgo.exe?grab_id=0&page_id=1078&query=cord%20blood%20banking&hiword=bloody %20CORDE%20CORDER%20CORDES%20CORDLE%20CORDS%20banking%20blood%20co rd%20 13. Moise K. Umbilical cord stem cells. Obstet Gynecol. 2005 Dec;106(6):1393-407. 14. National Consultative Bioethics Committee for Health and Life Sciences. Umbilical cord blood banks for autologous use or for research. Opinion N074. 2002 Dec 12. Accessed May 1, 2007. Available at URL address: http://www.ccne-ethique.fr/english/start.htm 15. National Cord Blood Program. Cord blood banking. 2003-2004. Accessed May 1, 2007. Available at URL address: http://www.nationalcordbloodprogram.org/donation/why_donate_to_public_bank.html 16. National Marrow Donor Program. Umbilical cord blood donation. Updated 2005 Oct. Accessed May 1, 2007. Available at URL address: http://www.marrow.org/donor/cord_blood_donation_advanced.html Page 4 of 5

17. Royal College of Obstetricians and Gynaecologists. Scientific opinion paper:umbilical cord blood banking. Updated 2006 Jun. Accessed May 2, 2007. Available at URL address: http://www.rcog.org.uk/index.asp?pageid=545 18. Templeton A, Braude P. Umbilical cord blood banking and the RCOG. Lancet. 2007 Mar 31;369(9567):1077. 19. The Leukemia and Lymphona Society. Cord blood stem cell transplantation. 2005 Apr. Accessed May 1, 2007. Available at URL address: http://www.leukemialymphoma.org/attachments/national/br_1128624081.pdf 20. U.S. Food and Drug Administration. FDA improves the safety of human cells and tissues by finalizing new rules for Good Tissue Practice. Updated 2004 Nov 18. Accessed May 2, 2007. Available at URL address: http://www.fda.gov/bbs/topics/news/2004/new01137.html 21. Witte C. Cord blood storage: property and liability issues. J Legal Med. 2005.26:275-92. Page 5 of 5