Latest Review Date: January 2024

Category:  Surgical                                                                

POLICY:

Mesenchymal stem cell therapy for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue, is considered investigational.

Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells, for all orthopedic applications is considered investigational.

Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Mesenchymal stem cells (MSCs) have the capability to differentiate into a variety of tissue types, including various musculoskeletal tissues. Potential uses of MSCs for orthopedic applications include treatment of damaged bone, cartilage, ligaments, tendons and intervertebral discs.

Mesenchymal Stem Cells

Mesenchymal stem cells (MSCs) are multipotent cells (also called stromal multipotent cells) that can differentiate into various tissues including organs, trabecular bone, tendon, articular cartilage, ligaments, muscle, and adipose tissue. MSCs are associated with the blood vessels within bone marrow, synovium, fat, and muscle, where they can be mobilized for endogenous repair as occurs with healing of bone fractures. Tissues, such as muscle, cartilage, tendon, ligaments, and vertebral discs, show limited capacity for endogenous repair because of the limited presence of the triad of tissue functional components: vasculature, nerves, and lymphatics. Orthobiologics is a term introduced to describe interventions using cells and biomaterials to support healing and repair. Cell therapy is the application of MSCs directly to a musculoskeletal site. Tissue engineering techniques use MSCs and/or bioactive molecules such as growth factors and scaffold combinations to improve the efficiency of repair or regeneration of damaged musculoskeletal tissues.

Bone marrow aspirate is considered to be the most accessible source and thus the most common place to isolate MSCs for treatment of musculoskeletal disease. However, harvesting MSCs from bone marrow requires an additional procedure that may result in donor site morbidity. In addition, the number of MSCs in bone marrow is low, and the number and differentiation capacity of bone marrow derived MSCs decreases with age, limiting their efficiency when isolated from older patients.

In vivo, the fate of stem cells is regulated by signals in the local 3-dimensional microenvironment from the extracellular matrix and neighboring cells. It is believed that the success of tissue engineering with MSCs will also require an appropriate 3-dimensional scaffold or matrix, culture conditions for tissue-specific induction, and implantation techniques that provide appropriate biomechanical forces and mechanical stimulation. The ability to induce cell division and differentiation without adverse effects, such as the formation of neoplasms, remains a significant concern. Given that each tissue type requires different culture conditions, induction factors (signaling proteins, cytokines, growth factors), and implantation techniques, each preparation must be individually examined.

This policy does not address unprocessed allograft bone or products that do not require mixing with stem cells (product examples are shown in Tables 1 and 2 for informational purposes).

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through November 10, 2023.  

Summary of Evidence

For individuals who have cartilage defects, meniscal defects, joint fusion procedures, or osteonecrosis who receive stem cell therapy, the evidence includes randomized controlled trials and nonrandomized comparative trials. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Despite continued research into the methods of harvesting and delivering treatment, there are uncertainties regarding the optimal source of cells and the delivery method. Studies have included MSCs from bone marrow, adipose tissue, and peripheral blood. Overall, the quality of evidence is low and there is a possibility of publication bias. The strongest evidence to date is on autologous MSCs expanded from bone marrow, which includes several phase 1/2 RCTs and a phase 3 RCT (which also evaluated other cell therapies). The phase 3 trial did not indicate significant improvements with the cell therapy modalities relative to active-control intra-articular corticosteroid injections for patients with knee osteoarthritis after 12 months of follow-up. Another recent phase 3 RCT evaluated autologous MSCs expanded from abdominal adipose tissue for treatment of knee osteoarthritis; this trial indicated autologous adipose derived MSCs were more effective than matching placebo injections in improving pain, function, and other patient-reported outcomes after 6 months of follow-up. These phase 3 trials' mixed findings may be related to differences in the cell therapy modalities used, baseline cohort characteristics, and/or the use of an active vs placebo control. Additional study with longer follow-up is needed to evaluate the long-term efficacy and safety of these procedures. Also, expanded MSCs for orthopedic applications are not FDA approved (concentrated autologous MSCs do not require agency approval). Overall, there is a lack clear of evidence that clinical outcomes are improved. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Rheumatology and Arthritis Foundation

In 2019, guidelines from the American College of Rheumatology and Arthritis Foundation on osteoarthritis (OA) of the hand, hip, andknee gave a strong recommendation against stem cell injections in patients with knee and/or hip OA, noting the heterogeneity inpreparations and lack of standardization of techniques.No recommendation was made for hand OA, since efficacy of stem cellshas not been evaluated.

American Association of Orthopaedic Surgeons

A 2020 guideline from American Association of Orthopaedic Surgeons on the management of glenohumeral joint OA, endorsed by several other societies, states that injectable biologics such as stem cells cannot be recommended in the treatment glenohumeral joint osteoarthritis. There was consensus from the panel that better standardization and high-quality evidence from clinical trials is needed to provide definitive evidence on the efficacy of biologics in glenohumeral OA. The strength of evidence was rated as no reliable scientific evidence to determine benefits and harms.

The 2021 guideline on treatment of osteoarthritis of the knee does not address stem cell injections.

American Association of Neurological Surgeons

The American Association of Neurological Surgeons 2014 guidelines on fusion procedures for degenerative disease of the lumbar spine related to this evidence review have indicated that “The use of demineralized bone matrix (DBM) as a bone graft extender is an option for 1- and 2-level instrumented posterolateral fusions. Demineralized Bone Matrix: Grade C (poor level of evidence).”

U.S. Preventive Services Task Force Recommendations

Not Applicable

KEY WORDS:

Allostem®, Chondrogen™, Cartistem®, stem cell therapy for orthopedic applications, mesenchymal stem cells (MSCs), bone matrix containing viable stem cell, Osteocel®, map3, nanOss®, Regenexx™, Regenerative Sciences, Trinity Evolution Matrix, Vitoss®, demineralized bone matrix (DBM), Rotator cuff tears, InGeneron Cell Therapy, Adipose-derived regenerative cell (ADRC) therapy, Transpose® RT cell therapy, CopiOs, Integra MOZAIK, DynaGraft, DBX, Formagraft 

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Mesenchymal stem cells (MSCs) are included in these regulations. The regulatory status of the stem cell or stem cell-containing products addressed in this review is summarized below.

Concentrated autologous MSCs do not require approval by the U.S. Food and Drug Administration (FDA).

The following products are examples of commercialized demineralized bone matrix (DBM) products. They are marketed as containing viable stem cells. In some instances, manufacturers have received communications and inquiries from FDA related to the appropriateness of their marketing products that are dependent on living cells for their function. The following descriptions are from the product literature.

• AlloStem® (AlloSource) is a partially demineralized allograft bone seeded with adipose-derived MSCs.
• Map3® (rti Surgical) contains cortical cancellous bone chips, DBM, and cryopreserved multipotent adult progenitor cells (MAPC®).
• Osteocel Plus® (NuVasive) is a DBM combined with viable MSCs isolated from allogeneic bone marrow.
• Trinity Evolution Matrix™ (Orthofix) is a DBM combined with viable MSCs isolated from allogeneic bone marrow.
• Other products contain DBM alone and are designed to be mixed with bone marrow aspirate:
  • Fusion Flex™ (Wright Medical) is a dehydrated moldable DBM scaffold (strips and cubes) that will absorb autologous bone marrow aspirate.
  • Ignite® (Wright Medical) is an injectable graft with DBM that can be combined with autologous bone marrow aspirate.

A number of DBM combination products have been cleared for marketing by FDA through the 510(k) process.

Tables 1 and 2 provide a representative sample of these products, differentiated by whether they must be mixed with autologous MSCs

Table 1. Examples of Demineralized Bone Matrix Products Cleared by FDA that Do Not Require Mixing with Autologous MSCs

FDA: Food and Drug Administration; MSCs: mesenchymal stem cells.

Table 2. Examples of Demineralized Bone Matrix Products Cleared by FDA that Require Mixing with Autologous MSCs

FDA: Food and Drug Administration; MSCs: mesenchymal stem cells.

In 2020, the FDA updated their guidance on "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use".

Human cells, tissues, and cellular and tissue-based products (HCT/P) are defined as human cells or tissues that are intended for implantation, transplantation,  infusion, or transfer into a human recipient. If an HCT/P does not meet the criteria below and does not qualify for any of the stated exceptions, the HCT/P will be regulated as a drug, device, and/or biological product and applicable regulations and premarket review will be required.

An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria:

1. “The HCT/P is minimally manipulated;
2. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
3. The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
4. Either:
   1. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
   2. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and: a) Is for autologous use; b) Is for allogeneic use in a first-degree or second-degree blood relative; or c) Is for reproductive use."

The FDA does not consider the use of stem cells for orthopedic procedures to be homologous use. 

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: 

CPT Codes:    

REFERENCES:

1. American Academy of Orthopaedic Surgeons. Management of Glenohumeral Joint Osteoarthritis Evidence-Based Clinical Practice Guideline. www.aaos.org/globalassets/quality-and-practice-resources/glenohumeral/gjo-cpg.pdf.
2. American Academy of Orthopaedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty). www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/oak3cpg.pdf.
3. Borakati A, Mafi R, Mafi P, et al. A systematic review and meta-analysis of clinical trials of mesenchymal stem cell therapy for cartilage repair. Curr Stem Cell Res Ther. Feb 23 2018; 13(3): 215-225.
4. Centeno CJ, Schultz JR, Cheever M, et al. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther 2010; 5(1):81-93.
5. Eastlack RK, Garfin SR, Brown CR, et al. Osteocel plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study. Spine (Phila Pa 1976). Oct 15 2014; 39(22):E1331-1337.
6. Emadedin M, Labibzadeh N, Liastani MG, et al. Intra-articular implantation of autologous bone marrow-derived mesenchymal stromal cells to treat knee osteoarthritis: a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Oct;20(10):1238- 1246.
7. Goldberg A, Mitchell K, Soans J, et al. The use of mesenchymal stem cells for cartilage repair and regeneration: a systematic review. Mar 09 2017;12(1):39.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Jin L, Yang G, Men X, et al. Intra-articular Injection of Mesenchymal Stem Cells After High Tibial Osteotomy: A Systematic Review andMeta-analysis. Orthop J Sports Med. Nov 2022; 10(11): 23259671221133784.
10. Jones CP, Loveland J, Atkinson BL, et al. Prospective, multicenter evaluation of allogeneic bone matrix containing viable osteogenic cells in foot and/or ankle arthrodesis. Foot Ankle Int. Oct 2015;36(10):1129-1137.
11. Kaiser MG, Groff MW, Watters WC, 3rd, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion. J Neurosurg Spine. Jul 2014;21(1):106-132.
12. Kim SH, Djaja YP, Park YB, et al. Intra-articular Injection of Culture-Expanded Mesenchymal Stem Cells Without AdjuvantSurgery in Knee Osteoarthritis: A Systematic Review and Meta-analysis. Am J Sports Med. Sep 2020; 48(11): 2839-2849.
13. Kim KI, Lee MC, Lee JH, et al. Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Sports Med. Jul 2023; 51(9): 2243-2253.
14. Koh YG, Kwon OR, Kim YS, et al. Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy. Nov 2014; 30(11):1453-1460.
15. Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for theManagement of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). Feb 2020; 72(2): 149-162.
16. Lamo-Espinosa JM, Mora G, Blanco JF, et al. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow-up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul;16(1).
17. Lamo-Espinosa JM, Mora G, Blanco JF et al. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug;14(1).
18. Lim HC, Park YB, Ha CW, et al. Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture forLarge, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up. Orthop J Sports Med. Jan 2021; 9(1): 2325967120973052.
19. Maheshwer B, Polce EM, Paul K, et al. Regenerative Potential of Mesenchymal Stem Cells for the Treatment of KneeOsteoarthritis and Chondral Defects: A Systematic Review and Meta-analysis. Arthroscopy. Jan 2021; 37(1): 362-378.
20. Mautner K, Gottschalk M, Boden SD, et al. Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial. Nat Med. Nov 02 2023.
21. Peppers TA, Bullard DE, Vanichkachorn JS, et al. Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution(R) Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion. J Orthop Surg Res. Apr 26 2017;12(1):67.
22. Sen RK, Tripathy SK, Aggarwal S et al. Early results of core decompression and autologous bone marrow mononuclear cells instillation in femoral head osteonecrosis: a randomized control study. J Arthroplasty 2012; 27(5):679-686.
23. Shapiro SA, Kazmerchak SE, Heckman MG, et al. A prospective, single-blind, placebo-controlled trial of bone marrow aspirate concentrate for knee osteoarthritis. Am J Sports Med. Jan 2017;45(1):82-90.
24. U.S. Food & Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-BasedProducts: Minimal Manipulation and Homologous Use. www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal.
25. Vangsness CT, Jr., Farr J, 2nd, Boyd J et al. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am 2014; 96(2):90-98.
26. Vanichkachorn J, Peppers T, Bullard D, et al. A prospective clinical and radiographic 12-month outcome study of patients undergoing single-level anterior cervical discectomy and fusion for symptomatic cervical degenerative disc disease utilizing a novel viable allogeneic, cancellous, bone matrix (trinity evolution) with a comparison to historical controls. Eur Spine J. Jul 2016;25(7):2233-2238.
27. Vega A, Martin-Ferrero MA, Del Canto F, et al. Treatment of knee osteoarthritis with allogeneic bone marrow mesenchymal stem cells: a randomized controlled trial. Transplantation. Aug 2015;99(8):1681-1690.
28. Wakitani S, Imoto K, Yamamoto T, et al. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage 2002; 10(3):199-206.
29. Wakitani S, Nawata M, Tensho K, et al. Repair of articular cartilage defects in the patello-femoral joint with autologous bone marrow mesenchymal cell transplantation: Three case reports involving nine defects in five knees. J Tissue Eng Regen Med 2007; 1(1):74-79.
30. Wakitani S, Okabe T, Horibe S et al. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med 2011; 5(2):146-150.
31. Whitehouse MR, Howells NR, Parry MC, et al. Repair of torn avascular meniscal cartilage using undifferentiated autologous mesenchymal stem cells: from in vitro optimization to a first-in-human study. Stem Cells Transl Med. Apr 2017;6(4):1237-1248.
32. Wiggers TG, Winters M, Van den Boom NA, et al. Autologous stem cell therapy in knee osteoarthritis: a systematic review ofrandomised controlled trials. Br J Sports Med. Oct 2021; 55(20): 1161-1169.
33. Wong KL, Lee KB, Tai BC et al. Injectable cultured bone marrow-derived mesenchymal stem cells in varus knees with cartilage defects undergoing high tibial osteotomy: a prospective, randomized controlled clinical trial with 2 years' follow-up. Arthroscopy 2013; 29(12):2020-2028.
34. Zaffagnini S, Andriolo L, Boffa A, et al. Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of KneeOsteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up. Am J Sports Med. Sep 2022; 50(11): 2881-2892.
35. Zhao D, Cui D, Wang B et al. Treatment of early stage osteonecrosis of the femoral head with autologous implantation of bone marrow-derived and cultured mesenchymal stem cells. Bone 2012; 50(1):325-330.

POLICY HISTORY:

Medical Policy Panel, April 2010

Medical Policy Group, May 2010 (2)

Medical Policy Administration Committee, May 2010

Available for comment May 26-July 9, 2010

Medical Policy Group, April 2011 (3): Updated Key Points, References

Medical Policy Group, October 2011 (3): Updated CPT Codes

Medical Policy Administration Committee, October 2011

Available for comment October 5 through November 21, 2011

Medical Policy Group, December 2011 (3): 2012 Code Updates: Verbiage change to code 38230 & added code 38323

Medical Policy Group, April 2012 (3): 2012 Updates to Key Points and References

Medical Policy Panel, April 2013

Medical Policy Group, April 2013 (3):  2013 Updates to Key Points, Approved by Governing Bodies and References; no change in policy statement

Medical Policy Panel, April 2014

Medical Policy Group, April 2014 (3):  2014 Updates to Key Points, Governing Bodies, Key Words, References; Policy statement updated to reflect “Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells, for all orthopedic applications medical criteria for coverage and is considered investigational.”

Available for comment April 25 through June 8, 2014

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (2):2015 Updates to Title- title change to “Orthopedic application of stem cell therapy (including allografts and bone substitute products used with autologous bone marrow,” Key Points, Approved by Governing Bodies, Current Coding, removed unrelated CPT codes 38220 and 38221, and References. Policy statement updated to include statement “allograft or synthetic bone graft substitutes that must be used with autologous blood or bone marrow medical criteria for coverage and is considered investigational.”

Medical Administration Committee, May 2015

Available for comment May 6 through June 19, 2015

Medical Policy Panel, January 2016

Medical Policy Group, February 2016 (2): 2016 Updates to Title-the word Products removed from title, Key Points, Key Words, and References; no change to policy statement.

Medical Policy Panel, July 2017

Medical Policy Group, August 2017 (7): Updates to Description, Key Points, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, January 2018

Medical Policy Group, February 2018 (7): Updates to Key Points, Coding and References.

Medical Policy Panel, January 2018

Medical Policy Group, February 2019 (7): Update to Key Points and References. Removed previous Policy Statement from 2015. No change in intent.

Medical Policy Group, December 2019: 2020 Annual Coding Update. Added CPT codes  0565T and 0566T to the Current coding section. No change in Policy Statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (7): Update to Key Points and References. No change in Policy Statement.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (7): Update to Key Points and References. Policy section updated to remove not medically necessary from statement, no change to intent.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (7): Update to Key Points, Approved by Governing Bodies, and References. No change in Policy Statement.

Medical Policy Group, June 2022: 2022 Quarterly Coding Update. Added CPT codes 0717T, 0718T to the Current coding section. Key Words added: “Rotator cuff tears, InGeneron Cell Therapy, Adipose-derived regenerative cell (ADRC) therapy, Transpose® RT cell therapy”

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (7): Update to Key Points and References. No change in Policy Statement.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (7): Update to Description, Key Points, Approved by Governing Bodies, Benefit Application, and References. Added Key Words: “CopiOs, Integra MOZAIK, DynaGraft, DBX, Formagraft.” No change in Policy Statement.

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.