Latest Review Date: March 2024

Category: Surgery                                                                  

POLICY:

Transplantation of cord blood stem cells from related or unrelated donors may be considered medically necessary in individuals with an appropriate indication for allogeneic stem-cell transplant.**

Transplantation of cord blood stem cells from related or unrelated donors is considered investigational in all other situations.

Collection and storage of cord blood from a neonate may be considered medically necessary when an allogeneic transplant is imminent in an identified recipient with a diagnosis that is consistent with the possible need for an allogeneic transplant.

Prophylactic collection and storage of cord blood from a neonate is considered investigational when proposed for some unspecified future use as an autologous stem-cell transplant in the original donor, or for some unspecified future use as an allogeneic stem-cell transplant in a related or unrelated donor.

**Please refer to the reference policies for specific conditions/diseases that have individual selection criteria regarding situations for which allogeneic stem-cell transplantation may be considered medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

This policy addresses the collection, storage and transplantation of placental/umbilical cord blood (“cord blood”) as a source of stem cells for allogeneic and autologous stem-cell transplantation.

Hematopoietic Cell Transplantation

Hematopoietic Cell Transplantation (HCT) is a procedure in which hematopoietic stem cells are intravenously infused to restore bone marrow and immune function in cancer individuals who receive bone marrow-toxic doses of cytotoxic drugs with or without whole-body radiotherapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT) or a donor (allogeneic HCT [allo-HCT]). These cells can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates.

Immunologic compatibility between infused hematopoietic stem cells and the recipient is not an issue in autologous HCT. In allogeneic stem cell transplantation, immunologic compatibility between donor and individual is a critical factor for achieving a successful outcome. Compatibility is established by typing of human leukocyte antigens (HLA) using cellular, serologic, or molecular techniques. HLA refers to the gene complex expressed at the HLA-A, -B, and -DR (antigen-D related) loci on each arm of chromosome six. An acceptable donor will match the individual at all or most of the HLA loci.

Conditioning for Hematopoietic Cell Transplantation

Conventional Conditioning

The conventional (“classical”) practice of allo-HCT involves administration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to cause bone marrow ablation in the recipient. The beneficial treatment effect of this procedure is due to a combination of the initial eradication of malignant cells and subsequent graft-versus-malignancy (GVM) effect mediated by non-self- immunologic effector cells. While the slower graft-versus-malignancy (GVM) effect is considered the potentially curative component, it may be overwhelmed by existing disease in the absence of pretransplant conditioning. Intense conditioning regimens are limited to individuals who are sufficiently medically fit to tolerate substantial adverse effects. These include opportunistic infections secondary to loss of endogenous bone marrow function and organ damage or failure caused by the cytotoxic drugs. Subsequent to graft infusion in allo-HCT, immunosuppressant drugs are required to minimize graft rejection and graft-versus-host disease, which increases susceptibility to opportunistic infections.

The success of autologous HCT is predicated on the potential of cytotoxic chemotherapy, with or without radiotherapy, to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of the bone marrow with presumably normal hematopoietic stem cells obtained from the individual before undergoing bone marrow ablation. Therefore, autologous HCT is typically performed as consolidation therapy when the individual’s disease is in complete remission. Individuals who undergo autologous HCT are also susceptible to chemotherapy-related toxicities and opportunistic infections before engraftment, but not graft-versus-host disease.

Reduced-Intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

Reduced-Intensity Conditioning (RIC) refers to the pretransplant use of lower doses of cytotoxic drugs or less intense regimens of radiotherapy than are used in traditional full-dose myeloablative conditioning treatments. Although the definition of RIC is variable, with numerous versions employed, all regimens seek to balance the competing effects of relapse due to residual disease and non-relapse mortality. The goal of RIC is to reduce disease burden and to minimize associated treatment-related morbidity and non-relapse mortality in the period during which the beneficial graft-versus-malignancy (GVM) effect of allogeneic transplantation develops. RIC regimens range from nearly total myeloablative to minimally myeloablative with lymphoablation, with intensity tailored to specific diseases and individual condition. Individuals who undergo RIC with allo-HCT initially demonstrate donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to full-donor chimerism. In this review, the term reduced-intensity conditioning will refer to all conditioning regimens intended to be nonmyeloablative.

KEY POINTS:

The most recent update via MEDLINE was through March 18, 2024.

Summary of Evidence

For individuals who have an appropriate indication for allogeneic stem cell transplant who receive cord blood as a source of stem cells, the evidence includes a number of observational studies, a meta-analysis of observational studies, and a randomized controlled trial comparing outcomes after single- or double-cord blood units. Relevant outcomes are overall survival, disease-specific survival, resource utilization, and treatment-related mortality. A meta-analysis of observational studies found similar survival outcomes and lower graft-versus-host disease after cord blood transplantation than bone marrow transplantation, but a randomized controlled trial showed improved survival rates with haploid identical bone marrow transplantation over umbilical cord blood transplantation.  In another RCT, survival rates were similar after single- and double- unit cord blood transplantation.  The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have an unspecified potential future need for stem cell transplant who receive prophylactic collection and storage of cord blood, the evidence includes no published studies. Relevant outcomes are overall survival, disease-specific survival, resource utilization, and treatment-related mortality. No evidence was identified on the safety or effectiveness of autologous cord blood transplantation from prophylactically stored cord blood for the treatment of malignant neoplasms. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Academy of Pediatrics

A position statement on cord blood banking for potential future transplantation was published by the American Academy of Pediatrics in 2017. The Academy recommended cord blood banking for public use, with a more limited role for private cord blood banking for families with a known fatal illness that could be rescued by cord blood transplant.

American College of Obstetricians and Gynecologists

The American College of Obstetricians and Gynecologists Number 771 (replaces Committee Opinion 648 and updated 2019. Reaffirmed 2023) published an opinion on umbilical cord blood (UCB) banking. The statement discussed counseling individuals on options for UCB banking, as well as the benefits and limitations of this practice. The relevant recommendations included the following:

• “[UCB] collected from a neonate cannot be used to treat a genetic disease or malignancy in that same individual.”
• The available evidence does not support the routine collection and storage of [UCBC] with a private cord blood bank.
• “Private [UCB] banking may be considered when there is knowledge of a family member with a medical condition (malignant or genetic) who could potentially benefit from cord blood transplantation.”
• “Public [UCB] banking is the recommended method of obtaining [UBC] for use in transplantation, immune therapies, or other medically validated indications.”
• “Umbilical cord blood collection should not compromise obstetric or neonatal care or alter routine practice for the timing of umbilical cord clamping with the rare exception of medical indications for directed donation.”
• “The current indications for cord blood transplant are limited to select genetic, hematologic, and malignant disorders.”
• “If a patient requests information about [UCB] banking, balanced and accurate information regarding the advantages and disadvantages of public and private [UCB] banking should be provided.”

The ACOG Committee Opinion Number 814  (Interim Update that replaces Committee Opinion 684, December 2020. Reaffirmed 2023) regarding Delayed Umbilical Cord Clamping After Birth effects on UCB banking states that in cases in which a individual and family are planning donation of umbilical cord blood, immediate cord clamping may increase the yield of cord blood acquired. However, in the absence of directed donation, the benefits to the infant of transfusion of additional blood volume at birth likely exceed the benefits of banking that volume for possible future usage. Families who are considering banking of umbilical cord blood should be counseled accordingly.

American Society for Blood and Marrow Transplantation

On behalf of the American Society for Blood and Marrow Transplantation, (Ballen, et al., 2008), published recommendations related to the banking of umbilical cord blood:

1. Public banking of cord blood is encouraged where possible.
2. Storage of cord blood for autologous (i.e., personal) use is not recommended.
3. Family member banking (collecting and storing cord blood for a family member) is recommended when there is a sibling with a disease that may be successfully treated with an allogeneic transplant.
4. Family member banking on behalf of a parent with a disease that may be successfully treated with an allogeneic transplant is only recommended when there are shared HLA antigens between the parents.

American Society of Transplantation and Cellular Therapy

In 2020, the American Society of Transplantation and Cellular Therapy released an evidence-based review on hematopoietic cell transplantation for treating newly diagnosed adult acute myeloid leukemia. The summary stated that a haploidentical-related donor is preferred over UCB in the absence of a fully HLA-matched donor, but UCB unit transplantation is an option for centers with this expertise.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cord Blood as a Source of Stem Cells, Transplantation, Placental and Umbilical Cord Blood as a Source of Stem Cells, cord blood, stem cell transplant, placental blood, umbilical cord blood

APPROVED BY GOVERNING BODIES:

According to the U.S. Food and Drug Administration (FDA), cord blood stored for potential use by a patient unrelated to the donor meets the definitions of “drug” and “biological products.” As such, products must be licensed under a biologics license application or an investigational new drug application before use. Facilities that prepare cord blood units only for autologous and/or first- or second-degree relatives are required to register and list their products, adhere to Good Tissue Practices issued by the FDA, and use applicable processes for donor suitability determination.

Also, the U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under the Code of Federal Regulation title 21, parts 1270 and 1271.  Hematopoietic stem cells are included in these regulations.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

HCPCS Codes:

REFERENCES:

1. ACOG Committee Opinion No. 648: Umbilical Cord Blood Banking. (2015). Obstetrics and gynecology, 126(6), e127–e129.
2. ACOG Committee Opinion No. 771: umbilical cord banking. Obstet Gynecol. 2019 Mar; 133(3): e249e253. 
3. American Academy of Pediatrics Section of Hematology/Oncology; American Academy of Pediatrics Section on Allergy/Immunology; Lubin BH, Shearer WT. Cord blood banking for potential future transplant. Pediatrics 2007; 119(1):165-170.
4. American Association of Blood Banks (AABB). AABB Accredited Cord Blood (CB) Facilities. www.aabb.org/sa/facilities/celltherapy/Pages/CordBloodAccrFac.aspx.
5. American College of Obstetricians and Gynecologists (ACOG). Committee Opinion Number 814. December 2020. Delayed Umbilical Cord Clamping After Birth. www.acog.org/clinical/clinical-guidance/committee-opinion.
6. Ballen KK, Barker JN, Stewart SK et al. Collection and preservation of cord blood for personal use. Biol Blood Marrow Transplant 2008; 14(3):356-363.
7. Barker JN, Byam C, Scaradavou A. How I treat: the selection and acquisition of unrelated cord blood grafts. Blood 2011; 117(8):2332-2339.
8. Barker JN, Weisdorf DJ, DeFor TE et al. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood 2005; 105(3):1343-1347.
9. Baron F, Ruggeri A, Beohou E, et al. Single- or double-unit UCBT following RIC in adults with AL: a report from Eurocord, the ALWP and the CTIWP of the EBMT. J Hematol Oncol. Jun 21 2017; 10(1):128.
10. Blue Cross Blue Shield Association.  Technology Evaluation Center (TEC) Assessment; Placental and Umbilical Cord Blood as a Source of Stem Cell for Hematopoietic Support.1996: Volume 11, Tab 17.
11. Blue Cross Blue Shield Association.  Technology Evaluation Center (TEC) Assessment; Transplanting Adult Patients with Hematopoietic Stem Cell from Placental and Umbilical Cord Blood. 2001: Volume 16, Tab 17. 
12. Chao  N. Collection and storage of umbilical cord blood for hematopoietic cell transplantation. In: Rosmarin  A, ed. UpToDate. Watham, Mass.: UpToDate, 2024. www.uptodate.com/contents/collection-and-storage-of-umbilical-cord-blood-for-hematopoietic-cell-transplantation?
13. Dholaria B, Savani BN, Hamilton BK, et al. Hematopoietic Cell Transplantation in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia: An Evidence-Based Review from the American Society of Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. Sep 20 2020.
14. Food and Drug Administration (FDA). Cord Blood Banking: Information for Consumers (July 23, 2012). www.fda.gov/biologicsbloodvaccines/resourcesforyou/consumers/ucm236044.htm. 
15. Fraser J, Cairo MS, Wagner E et al. Cord Blood Transplantation Study (COBLT): cord blood bank standard operating procedures. J Hematother 1998; 7(6):521-561.
16. Fuchs EJ, O'Donnell PV, Eapen M, et al. Double unrelated umbilical cord blood versus HLA-haploidentical bone marrow transplantation (BMT CTN 1101). Blood. Aug 31 2020.
17. Godley LA, van Besien K. The next frontier for stem cell transplantation finding a donor for all. JAMA 2010; 303(14):1421-1422.
18. Hough R, Danby R, Russell N, et al. Recommendations for a standard UK approach to incorporating umbilical cord blood into clinical transplantation practice: an update on cord blood unit selection, donor selection algorithms and conditioning protocols. Br J Haematol. Feb 2016; 172(3):360-370.
19. Hsu J, Artz A, Mayer SA, et al. Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation for High-Risk Lymphoma and Chronic Lymphoblastic Leukemia. Biol Blood Marrow Transplant. Feb 2018; 24(2):359-365. 
20. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
21. Kato K, Choi I, Wake A, et al. Treatment of patients with adult T cell leukemia/lymphoma with cord blood transplantation: a Japanese nationwide retrospective survey. Biol Blood Marrow Transplant. Dec 2014; 20(12):1968-1974.
22. Kurtzberg J, Cairo MS, Fraser JK et al. Results of the cord blood transplantation study (COBLT) study unrelated donor banking program. Transfusion 2005; 45(6):842-855.
23. Kurtzberg J, Laughlin M, Graham ML et al. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. N Engl J Med 1996; 335(3):157-166.
24. Kurtzberg J, Prasad VK, Carter SL et al. Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematological malignancies. Blood 2008; 112(10):4318-4327.
25. Kurtzberg J. Update on umbilical cord blood transplantation. Curr Opin Pediatr 2009; 21(1):22-29.
26. Li D, Li X, Liao L, et al. Unrelated cord blood transplantation versus haploidentical transplantation in adult and pediatric patients with hematological malignancies-A meta-analysis and systematic review. Am J Blood Res. 2020; 10(1): 1-10.
27. Liu HL, Sun ZM, Geng LQ, et al. Similar survival, but better quality of life after myeloablative transplantation using unrelated cord blood vs matched sibling donors in adults with hematologic malignancies. Bone Marrow Transplant. Aug 2014; 49(8):1063-1069.
28. Lubin BH, Shearer WT. Cord blood banking for potential future transplantation. Pediatrics. Jan 2007; 119(1):165-170.
29. Martin PL, Carter SL, Kernan NA et al. Results of the cord blood transplantation study (COBLT): outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with lysosomal and peroxisomal storage diseases. Biol Blood Marrow Transplant 2006; 12(2):184-194.
30. Mo XD, Tang BL, Zhang XH, et al. Comparison of outcomes after umbilical cord blood and unmanipulated haploidentical hematopoietic stem cell transplantation in children with high-risk acute lymphoblastic leukemia. Int J Cancer. Nov 1 2016; 139(9):2106-2115.
31. NetCord-FACT. International standards for cord blood collection banking and release of information accreditation manual- Fifth Edition. September 2012. www.factwebsite.org/uploadedFiles/FACT_News/Draft%205th%20Edition%20NetCord-FACT%20Cord%20Blood%20Accreditation%20Manual.09.04.12.pdf. 
32. Park M, Lee YH, Kang HR, et al. Unrelated donor cord blood transplantation for non-malignant disorders in children and adolescents. Pediatr Transplant. Mar 2014; 18(2):221-229.
33. Peffault de Latour R, Brunstein CG, Porcher R et al. Similar Overall Survival Using Sibling, Unrelated Donor, and Cord Blood Grafts after Reduced-Intensity Conditioning for Older Patients with Acute Myelogenous Leukemia. Biol Blood Marrow Transplant 2013.
34. Poonsombudlert K, Kewcharoen J, Prueksapraopong C, et al. Post transplant cyclophosphamide based haplo-identical transplant versus umbilical cord blood transplant; a meta-analysis. Jpn J Clin Oncol. Oct 01 2019; 49(10): 924-931.
35. Prasad VK, Kurtzberg J. Emerging trends in transplantation of inherited metabolic diseases. Bone Marrow Transplant 2008; 41(2):99-108.
36. Rao M, Ahrlund-Richter L, Kaufman DS. Concise review: Cord blood banking, transplantation and induced pluripotent stem cell: success and opportunities. Stem Cells 2012; 30(1):55-60.
37. Rocha V, Cornish J, Sievers EL et al. Comparison of outcomes of unrelated bone marrow and umbilical cord blood transplants in children with acute leukemia. Blood 2001; 97(10):2962-2971.
38. Rubinstein P, Carrier C, Scaradavou A et al. Outcomes among 562 recipients of placental-blood transplants from unrelated donors. N Engl J Med 1998; 339(22):1565-1577.
39. Scaradavou A, Brunstein CG, Eapen M et al. Double unit grafts successfully extend the application of umbilical cord blood transplantation in adults with acute leukemia. Blood 2013; 121(5):752-758.
40. Shearer WT, Lubin BH, Cairo MS, et al. Cord Blood Banking for Potential Future Transplantation. Pediatrics. Nov 2017; 140(5).
41. Sponsored by Assistance Publique Hopitaux De Marseille. A Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in the Young With Acute Leukemia Remission (NCT01067300). www.clinicaltrials.gov.
42. Sponsored by Medical College of Wisconsin. Single versus double umbilical cord blood transplantation in children with high-risk leukemia and myelodysplasia (BMT CTN 0501) (NCT00412360). www.clinicaltrials.gov.
43. Thornley I, Eapen M, Sung L et al. Private cord blood banking: Experiences and views of pediatric hematopoietic cell transplantation physicians. Pediatrics 2009; 123(3):1011-1017.
44. U.S. Food and Drug Administration. Guidance for Industry: Minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution for specified indications. www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM187144.pdfUH.
45. Wagner JE, Jr., Eapen M, Carter S, et al. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. Oct 30 2014; 371(18):1685-1694.
46. Wagner JE, Rosenthal J, Sweetman R et al. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord blood from unrelated donors: analysis of engraftment and acute graft-versus-host disease. Blood 1996; 88(3):795-802.
47. Wall DA. Regulatory issues in cord blood banking and transplantation. Best Pract Res Clin Haematol 2010; 23(2):171-177.
48. Wallet HL, Sobh M, Morisset S, et al. Double umbilical cord blood transplantation for hematological malignancies: a long- term analysis from the SFGM-TC registry. Exp Hematol. Jul 2 2013.
49. Wu R, Ma L. Haploidentical Hematopoietic Stem Cell Transplantation Versus Umbilical Cord Blood Transplantation in Hematologic Malignancies: A Systematic Review and Meta-Analysis. Cell Transplant. Jan-Dec 2020; 29: 963689720964771.
50. Zhang H, Chen J, Que W. A meta-analysis of unrelated donor umbilical cord blood transplantation versus unrelated donor bone marrow transplantation in acute leukemia patients. Biol Blood Marrow Transplant 2012; 18(8):1164-1173.

POLICY HISTORY:

Medical Policy Group, September 1998 (3)

Medical Policy Group, January 2003 (3)

Medical Policy Group, June 2010 (2)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medical Policy Group, May 2012 (4): Policy unchanged. Updated Description and References.

Medical Policy Group, January 2013 (4): Update to Description, Key Points, and References

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (3): Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Key Points & References; no change in policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, October 2015 (2): 2105 Updates to Key Points and References, no change to policy statement. 

Medical Policy Panel, January 2016

Medical Policy Group, February 2016 (2): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Key Points and References; No change to policy statement.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (7): 2018 Updates to Key Points and References; No change to policy statement.

Medical Policy Panel, January 2019

Medical Policy Group, February, 2019 (3): Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (3): 2020 Updates to Description, Key Points, References, and Practice Guidelines and Position Statements. No changes to policy statement or intent.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (3): Updates to Description, Key Points, and References.  No change to policy statements.

Medical Policy Group, February 2021 (3): 2021 Updates to Description, Key Points, and References.  Policy statement updated to remove “not medically necessary, “no other changes to policy statement or intent. This policy is placed on biannual reviews/literature updates.

Medical Policy Group, March 2022 (3): 2022 Updates to Key Points. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, March 2023 (3): 2023 Updates Key Points, Practice Guidelines and Position Statements, Benefit Applications, and References. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.      

Medical Policy Group, March 2024 (3): 2024  Updates to Key Points, Approved by Governing Bodies, Benefit Application and References. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.                                                                                                          

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.