mp-156 - Medical Policies - Alabama
Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions
Policy Number: MP-156
Latest Review Date: April 2022
Policy Grade: A
Autologous chondrocyte implantation may be considered medically necessary for the treatment of disabling full-thickness articular cartilage defects of the knee caused by acute or repetitive trauma, when all of the following criteria are met:
- The patient is skeletally mature with documented closure of growth plates and not considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., age greater than 15 and less than 55 years); AND
- Focal, full-thickness (grade III or IV) unipolar lesions of the patella or the weight-bearing surface of the femoral condyles or trochlea at least 1.5 cm2 in size; AND
- Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect; AND
- Normal knee biomechanics or alignment and stability achieved concurrently with autologous chondrocyte implantation.
Autologous chondrocyte implantation for all other joints, including talar, and any indications other than those listed above is considered investigational.
Prophylactic harvesting of cells during other reconstructive or reparative procedures for possible future implantation is considered not medically necessary.
DESCRIPTION OF PROCEDURE OR SERVICE:
A variety of procedures are being developed to resurface articular cartilage defects. Autologous chondrocyte implantation (ACI) involves harvesting chondrocytes from healthy tissue, expanding the cells in vitro, and implanting the expanded cells into the chondral defect under a periosteal or fibrin patch. Second- and third- generation techniques include combinations of autologous chondrocytes, scaffolds, and growth factors. This procedure may be performed at the same time as other surgical procedures such as repair of tendons or ligaments, osteotomies for realignment of a joint, or meniscal allograft transplantation.
Damaged articular cartilage typically fails to heal on its own and can be associated with pain, loss of function, and disability, and may lead to debilitating osteoarthritis over time. These manifestations can severely impair an individual’s activities of daily living and adversely affect the quality of life.
Conventional treatment options include debridement, subchondral drilling, microfracture, and abrasion arthroplasty. Debridement involves the removal of synovial membrane, osteophytes, loose articular debris, and diseased cartilage and is capable of producing symptomatic relief. Subchondral drilling, microfracture, and abrasion arthroplasty attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect. Compared with the original hyaline cartilage, fibrocartilage has less capability to withstand shock or shearing force and can degenerate over time, often resulting in the return of clinical symptoms. Osteochondral grafts and autologous chondrocyte implantation (ACI) attempt to regenerate hyaline-like cartilage and thereby restore durable function. Osteochondral grafts for the treatment of articular cartilage defects are discussed in Medical Policy #248, Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions.
With ACI, a region of healthy articular cartilage is identified and biopsied through arthroscopy. The tissue is sent to a facility licensed by the U.S. Food and Drug Administration (FDA) where it is minced and enzymatically digested, and the chondrocytes are separated by filtration. The isolated chondrocytes are cultured for 11 to 21 days to expand the cell population, tested, and then shipped back for implantation. With the patient under general anesthesia, an arthrotomy is performed, and the chondral lesion is excised up to the normal surrounding cartilage. Methods to improve the first-generation ACI procedure have been developed, including the use of a scaffold or matrix-induced autologous chondrocyte implantation (MACI) composed of biocompatible carbohydrates, protein polymers, or synthetics. The only FDA-approved MACI product to date is supplied in a sheet, which is cut to size and fixed with fibrin glue. This procedure is considered technically easier and less time consuming than the first-generation technique, which required suturing of a periosteal or collagen patch and injection of chondrocytes under the patch.
Desired features of articular cartilage repair procedures are the ability (1) to be implanted easily, (2) to reduce surgical morbidity, (3) not to require harvesting of other tissues, (4) to enhance cell proliferation and maturation, (5) to maintain the phenotype, and (6) to integrate with the surrounding articular tissue. In addition to the potential to improve the formation and distribution of hyaline cartilage, use of a scaffold with MACI eliminates the need for harvesting and suture of a periosteal or collagen patch. A scaffold without cells may also support chondrocyte growth.
The most recent literature update was performed through February 16, 2022.
Summary of Evidence
For individuals who have focal articular cartilage lesion(s) of the weight-bearing surface of the femoral condyles, trochlea, or patella who receive ACI, the evidence includes systematic reviews, randomized controlled trials, and prospective observational studies. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, and quality of life. There is a large body of evidence on ACI for the treatment of focal articular cartilage lesions of the knee. For large lesions, ACI results in better outcomes than microfracture, particularly in the long term. In addition, there is a limit to the size of lesions that can be treated with osteochondral autograft transfer, due to a limit on the number of osteochondral cores that can be safely harvested. As a result, ACI has become the established treatment for large articular cartilage lesions in the knee. In 2017, first-generation ACI with a collagen cover was phased out and replaced with an ACI preparation that seeds the chondrocytes onto a bioresorbable collagen sponge. Although the implantation procedure for this second-generation ACI is less technically demanding, studies to date have not shown improved outcomes compared with first-generation ACI. Some evidence has suggested an increase in hypertrophy (overgrowth) of the new implant that may exceed that of the collagen membrane covered implant. Long-term studies with a larger number of patients will be needed to determine whether this hypertrophy impacts graft survival. Based on mid-term outcomes that approximate those of first-generation ACI and the lack of alternatives, secondgeneration ACI may be considered an option for large disabling full-thickness cartilage lesions of the knee. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals who have focal articular cartilage lesions of joints other than the knee who receive ACI, the evidence includes systematic reviews of case series. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, and quality of life. The greatest amount of literature is for ACI of the talus. Comparative trials are needed to determine whether ACI improves outcomes for lesions in joints other than the knee. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
American Academy of Orthopaedic Surgeons
In its 2010 guidelines on the diagnosis and treatment of osteochondritis dissecans (OCD), the American Academy of Orthopaedic Surgeons (AAOS) was unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature or mature patients with an unsalvageable osteochondritis dissecans lesion. This recommendation of insufficient evidence was based on a systematic review that found four level IV studies that addressed cartilage repair techniques for an unsalvageable OCD lesion. Since each of the level IV articles utilized different techniques, different outcome measures, and differing lengths of follow-up, the work group deemed that the evidence for any specific technique was inconclusive.
National Institute for Health and Clinical Excellence
In 2018, the National Institute for Health and Care Excellence updated its 2005 guidance on the use of autologous chondrocyte implantation. The NICE recommendations are stated below:
“… as an option for treating symptomatic articular cartilage defects of the femoral condyle and patella of
the knee (International Cartilage Repair Society grade III or IV) in adults, only if:
- the person has not had previous surgery to repair articular cartilage defects;
- there is minimal osteoarthritic damage to the knee (as assessed by clinicians experienced in investigating knee cartilage damage using a validated measure for knee osteoarthritis); and
- the defect is over 2 cm2."
U.S. Preventive Services Task Force Recommendations
Autologous chondrocyte transplantation (ACT), autologous chondrocyte implant (ACI), articular cartilage, chondrocytes, Carticel®, osteochrondritis dissecans (OCD), ChondroCelect, BioCart II, Cartilix, MACI®, Cartipatch, NeoCart, Hyalograft C
APPROVED BY GOVERNING BODIES:
The culturing of chondrocytes is considered by the U.S. Food and Drug Administration (FDA) to fall into the category of manipulated autologous structural (MAS) cells, which are subject to a biologic licensing requirement. In 1997, Carticel received FDA approval for the repair of clinically significant, “...symptomatic cartilaginous defects of the femoral condyle (medial lateral or trochlear) caused by acute or repetitive trauma.…”
In 2016, MACI® (matrix-induced autologous chondrocyte implantation [ACI]; Vericel), received FDA approval for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. MACI® consists of autologous chondrocytes which are cultured onto a bio-resorbable porcine-derived collagen membrane. In 2017, production of Carticel was phased out and MACI® is the only ACI product that is available in the U.S.
A number of other second-generation methods for implanting autologous chondrocytes in a biodegradable matrix are currently in development or testing or are available outside of the United States. They include Atelocollagen (Koken), a collagen gel; Bioseed® C (BioTissue Technologies), a polymer scaffold; CaReS (Ars Arthro), collagen gel; Cartilix (Biomet), a polymer hydrogel; Chondron (Sewon Cellontech), a fibrin gel; Hyalograft C (Fidia Advanced Polymers), a hyaluronic acid-based scaffold; NeoCart (Histogenics), an ACI with a 3-dimensional chondromatrix in a phase 3 trial; and Novocart®3D (Aesculap Biologics), a collagenchondroitin sulfate scaffold in a phase 3 trial. ChondroCelect® (TiGenix), characterized as a chondrocyte implantation with a completed phase 3 trial, uses a gene marker profile to determine in vivo cartilage-forming potential and thereby optimizes the phenotype (e.g., hyaline cartilage vs fibrocartilage) of the tissue produced with each ACI cell batch. Each batch of chondrocytes is graded based on the quantitative gene expression of a selection of positive and negative markers for hyaline cartilage formation. Both Hyalograft C and ChondroCelect® have been withdrawn from the market in Europe. In 2020, the FDA granted breakthrough status to Agili-C (CartiHeal, Ltd.), a proprietary biocompatible and biodegradable tapered-shape implant for the treatment of cartilage lesions in arthritic and non-arthritic joints that, when implanted into a pre-prepared osteochondral hole, acts as a 3D scaffold that potentially supports and promotes the regeneration of the articular cartilage and its underlying subchondral bone.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Autologous chondrocyte implantation, knee
Unlisted procedure, leg or ankle
Code range, arthroscopy of the knee
Autologous cultured chondrocytes, implant
Arthroscopy, knee, surgical for harvesting of cartilage (chondrocyte cells)
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- American Academy of Orthopaedic Surgeons. Clinical practice guideline on the diagnosis and treatment of osteochondritis dissecans. 2010. //www.aaos.org/research/guidelines/OCD_guideline.pdf.
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- Bartlett W, Skinner JA, Gooding CR, et al. Autologous chondrocyte implantation versus matrix-induced autologous chondrocyte implantation for osteochondral defects of the knee: a prospective, randomised study. J Bone Joint Surg Br. May 2005; 87(5):640-645.
- Basad E, Ishaque B, Bachmann G et al. Matrix-induced autologous chondrocyte implantation versus microfracture in the treatment of cartilage defects of the knee: a 2-year randomised study. Knee Surg Sports Traumatol Arthrosc 2010; 18(4):519-527.
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- Bin Abd Razak HR, Acharyya S, Tan SM, et al. Predictors of Midterm Outcomes after Medial Unicompartmental Knee Arthroplasty in Asians. Clin Orthop Surg. 2017 Dec;9(4).
- Brittberg M, Recker D, Ilgenfritz J, et al. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2018 May;46(6).
- Clement ND, MacDonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. Aug 2014; 22(8): 1933-9.
- Collins NJ, Misra D, Felson DT, et al. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S208-28.
- Copay AG, Eyberg B, Chung AS, et al. Minimum Clinically Important Difference: Current Trends in the Orthopaedic Literature, Part II: Lower Extremity: A Systematic Review. JBJS Rev. 2018 Sep;6(9).
- Devitt BM, Bell SW, Webster KE, et al. Surgical treatments of cartilage defects of the knee: Systematic review of randomised controlled trials. Knee. Jun 2017;24(3):508-517.
- Ebert JR, Fallon M, Wood DJ, et al. A prospective clinical and radiological evaluation at 5 years after arthroscopic matrix-induced autologous chondrocyte implantation. Am J Sports Med. Jan 2017;45(1):59-69.
- Ebert JR, Fallon M, Zheng MH, et al. A randomized trial comparing accelerated and traditional approaches to postoperative weight-bearing rehabilitation after matrix-induced autologous chondrocyte implantation: findings at 5 years. Am J Sports Med. Jul 2012;40(7):1527-1537.
- Ebert JR, Schneider A, Fallon M, et al. A comparison of 2-year outcomes in patients undergoing tibiofemoral or patellofemoral matrix-induced autologous chondrocyte implantation. Am J Sports Dec 2017; 45(14): 3243-3253.
- Ebert JR, Smith A, Edwards PK, et al. Factors predictive of outcome 5 years after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint. Am J Sports Med. Jun 2013;41(6):1245-1254.
- Ebert JR, Smith A, Fallon M, et al. Incidence, degree, and development of graft hypertrophy 24 months after matrix-induced autologous chondrocyte implantation: association with clinical outcomes. Am J Sports Med. Sep 2015; 43(9):2208-2215.
- Free online Modified Cincinnati Knee Rating System calculator. OrthoToolKit.https://www.orthotoolkit.com/cincinnati/.
- Gou GH, Tseng FJ, Wang SH, et al. Autologous Chondrocyte Implantation Versus Microfracture in the Knee: A Meta-analysis and Systematic Review. Arthroscopy. Jan 2020; 36(1): 289-303.
- Greco NJ, Anderson AF, Mann BJ, et al. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5).
- Gusi N, Olivares PR, Rajendram R. The EQ-5D Health-Related Quality of Life Questionnaire [Abstract]. In: Preedy VR, Watson RR, eds. Handbook of Disease Burdens and Quality of Life Measures. New York: Springer; 2010:87-89.
- Harris JD, Cavo M, Brophy R et al. Biological Knee Reconstruction: A Systematic Review of Combined Meniscal Allograft Transplantation and Cartilage Repair or Restoration. Arthroscopy 2011; 27(3):409-418.
- Harris JD, Siston RA, Pan X, et al. Autologous chondrocyte implantation: a systematic review. J Bone Joint Surg Am. Sep 15 2010; 92(12):2220-2233.
- Hu M, Li X, Xu X. Efficacy and safety of autologous chondrocyte implantation for osteochondral defects of the talus:a systematic review and meta-analysis. Arch Orthop Trauma Surg. Jun 14 2021.
- Lee WC, Bin Abd Razak HR, Allen JC, et al. Achieving Minimum Clinically Important Difference in Oxford Knee Score and Short Form-36 Physical Component Summary Is Less Likely with Single-Radius Compared with Multiradius Total Knee Arthroplasty in Asians. J Knee Surg. Mar 2019; 32(3): 227-232.
- Lee WC, Kwan YH, Chong HC, et al. The minimal clinically important difference for Knee Society Clinical Rating System after total knee arthroplasty for primary osteoarthritis. Knee Surg Sports Traumatol Arthrosc. Nov 2017; 25(11): 3354-3359.
- Meyerkort D, Ebert JR, Ackland TR, et al. Matrix-induced autologous chondrocyte implantation (MACI) for chondral defects in the patellofemoral joint. Knee Surg Sports Traumatol Arthrosc. Oct 2014; 22(10):2522-2530.
- Minas T, Gomoll AH, Rosenberger R et al. Increased failure rate of autologous chondrocyte implantation after previous treatment with marrow stimulation techniques. Am J Sports Med 2009; 37(5):902-908.
- Minas T, Von Keudell A, Bryant T et al. The John Insall Award: A minimum 10-year outcome study of autologous chondrocyte implantation. Clin Orthop Relat Res 2014; 472(1):41-51.
- Mistry H, Connock M, Pink J, et al. Autologous chondrocyte implantation in the knee: systematic review and economic evaluation. Health Technol Assess. Feb 2017;21(6):1-294.
- Mundi R, Bedi A, Chow L, et al. Cartilage Restoration of the Knee: A Systematic Review and Meta-Analysis of Level 1 Studies. Am J Sports Med. Jul 2016; 44(7):1888-1895.
- National Institute for Health and Care Excellence (NICE). Autologous chondrocyte implantation for treatingsymptomatic articular cartilage defects of the knee [TA508 ]. 2018;https://www.nice.org.uk/guidance/TA508/chapter/1-Recommendations.
- Nawaz SZ, Bentley G, Briggs TWR et al. Autologous chondrocyte implantation in the knee. J Bone Joint Surg Am 2014; 96(10):824-830.
- Niemeyer P, Pestka JM, Kreuz PC et al. Characteristic complications after autologous chondrocyte implantation for cartilage defects of the knee joint. Am J Sports Med 2008; 36(11):2091-2099.
- Niemeyer P, Salzmann G, Schmal H et al. Autologous chondrocyte implantation for the treatment of chondral and osteochondral defects of the talus: a meta-analysis of available evidence. Knee Surg Sports Traumatol Arthrosc 2012; 20(9):1696-1703.
- Riboh JC, Cvetanovich GL, Cole BJ, Yanke AB. Comparative efficacy of cartilage repair procedures in the knee: a network meta-analysis. Knee Surg Sports Traumatol Arthrosc. Dec 2017; 25(12):3786-3799.
- Roos EM, Engelhart L, Ranstam J, et al. ICRS Recommendation Document: Patient-Reported Outcome Instruments for Use in Patients with Articular Cartilage Defects. Cartilage. 2011 Apr;2(2).
- Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov;1:64.
- Sacolick DA, Kirven JC, Abouljoud MM, et al. The Treatment of Adult Osteochondritis Dissecans with Autologous Cartilage Implantation: A Systematic Review. J Knee Surg. 2019 Nov;32(11).
- Saris D, Price A, Widuchowski W et al. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-year follow-up of a prospective randomized trial. Am J Sports Med. Jun 2014; 42(6):1384-1394.
- Schuette HB, Kraeutler MJ, McCarty EC. Matrix-assisted autologous chondrocyte transplantation in the knee: a systematic review of mid- to long-term clinical outcomes. Orthop J Sports Med. Jun 2017; 5(6):2325967117709250.
- Shimozono Y, Yasui Y, Ross AW, et al. Scaffolds based therapy for osteochondral lesions of the talus: A systematic review. World J Orthop. Oct 18 2017;8(10):798-808.
- Zak L, Aldrian S, Wondrasch B, et al. Ability to return to sports 5 years after matrix-associated autologous chondrocyte transplantation in an average population of active patients. Am J Sports Med. Dec 2012; 40(12):2815-2821.
- Zamborsky R, Danisovic L. Surgical Techniques for Knee Cartilage Repair: An Updated Large-Scale Systematic Review and Network Meta-analysis of Randomized Controlled Trials. Arthroscopy. Mar 2020; 36(3): 845-858.
Medical Policy Group, April 2004 (1)
Medical Policy Administration Committee, April 2004
Available for comment June 30-July 15, 2004
Medical Policy Group, May 2005 (2)
Medical Policy Administration Committee, June 2005
Available for comment June 16-July 30, 2005
Medical Policy Group, April 2007 (1)
Medical Policy Administration Committee, May 2007
Available for comment May 8-June 21, 2007
Medical Review Group, November 2009 (2)
Medical Policy Administration Committee, December 2009
Available for comment December 4, 2009-January 19, 2010
Medical Policy Group, March 2010 (3)
Medical Policy Administration Committee April 2010
Available for comment April 15-May 29, 2010
Medical Policy Group, June 2011; Updated Policy, Key Points & References
Medical Policy Administration Committee July 2011
Available for comment July 6 through August 22, 2011
Medical Policy Group, June 2012 (3): 2012 Update includes Key Points and References
Medical Policy Panel, June 2013
Medical Policy Group, June 2013 (3): 2013 Updates to Title, Description, Policy Statement, Key Points, References, and Key words; removed “Transplantation” and replaced with “Implantation” and removed “and Other Cell-based Treatments of” from title; and treatments with autologous minced cartilage and allogeneic minced cartilage or cartilage cells from policy statements
Available for comment June 27 through August 10, 2013
Medical Policy Group, September 2013 (3): ad hoc clarification statement added to policy sections noting prophylactic harvesting of cells for possible future implantation does not meet criteria for coverage
Medical Policy Panel, June 2014
Medical Policy Group, June 2014 (3): 2014 Updates to Description, Key Points & References; no change in policy statement
Medical Policy Panel, June 2015
Medical Policy Group, July 2015 (2): 2015 Updates to Description, Key Points, and References, no change to policy statement.
Medical Policy Panel, October 2015
Medical Policy Group, October 2015 (2): 2015 Updates to Policy, Key Points, Approved by Governing Bodies, and References; updated policy statement to include coverage criteria for focal, full-thickness unipolar lesions of the patella.
Medical Policy Administration Committee November 2015
Medical Policy Panel, April 2017
Medical Policy Group, April 2017 (7): 2017 Updates to Description, Key Points, Approved by Governing Bodies, and References. Policy statement- updated policy statement to include coverage for matrix induced autologous chondrocyte implantation; deleted policy statement prior to June 13, 2013.
Medical Policy Administration Committee, May 2017
Available for comment April 26 through June 10, 2017
Medical Policy Panel, December 2017
Medical Policy Group, December 2017 (7): 2017 Updates to Description, Key Points and References. No change in Policy Statement.
Medical Policy Panel, April 2019
Medical Policy Group, April 2019 (7): 2019 Updates to Key Points and References. Removed old policy statement prior to November 2015. No change in intent.
Medical Policy Panel, April 2020
Medical Policy Group, April 2020 (7): Updates to Key Points and References. Deleted policy statement prior to April 30, 2017. No change in intent.
Medical Policy Group, January 2021 (7): Clarification to Policy Statement. No change in intent.
Medical Policy Panel, April 2021
Medical Policy Group, April 2021 (7): Updates to Key Points, Approved by Governing Bodies, and References. Policy section updated to remove not medically necessary from statement regarding use of autologous chondrocyte implantation in all other joints. No change in intent.
Medical Policy Panel, April 2022
Medical Policy Group, April 2022 (7): Updates to Key Points and References. No change to policy statements.
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:
- The technology must have final approval from the appropriate government regulatory bodies;
- The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
- The technology must improve the net health outcome;
- The technology must be as beneficial as any established alternatives;
- 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:
- In accordance with generally accepted standards of medical practice; and
- Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
- Not primarily for the convenience of the patient, physician or other health care provider; and
- 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.