Osteochondral Treatments for Defects of the Knee Product Applicability

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Medical Policy

Osteochondral Treatments for Defects of the Knee

Policy Number: OCA 3.965 Version Number: 11 Version Effective Date: 06/01/16

Product Applicability All Plan+ Products

Well Sense Health Plan Boston Medical Center HealthNet Plan New Hampshire Medicaid MassHealth NH Health Protection Program Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary The Plan considers autologous chondrocyte transplantation (ACT), osteochondral autograft transplantation (OATS/mosaicplasty), and osteochondral allograft transplantation procedures for osteochondral defects of the knee to be medically necessary when Plan medical criteria are met. Autologous chondrocyte transplantation (ACT), osteochondral allograft transplantation, and/or osteochondral autograft transplantation (OATS/ mosaicplasty) for other joints, including but not limited to the ankle (talus), are considered experimental and investigational. Prior authorization is required.

Osteochondral Treatments for Defects of the Knee

+ Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 1 of 14

It will be determined during the Plan’s prior authorization process if the service is considered medically necessary for the requested indication. See the Plan’s policy, Medically Necessary (policy number OCA 3.14), for the product-specific definitions of medically necessary treatment. Refer to the Plan’s policy, Experimental and Investigational Treatment (policy number OCA 3.12), for the product-specific definitions of experimental or investigational treatment.

Description of Item or Service Autologous Chondrocyte Implantation (ACI)/Autologous Chondrocyte Transplantation (ACT): A two-stage surgical procedure by which the patient’s own chondrocytes or cartilage cells are removed and grown in a lab to generate more cells. The cultured cells are then re-implanted into the knee at areas where there are cartilage defects with the goal of regenerating cartilage over the next 6-12 months to improve joint function and reduce pain.

Osteochondral Allograft Transplantation: A surgical procedure by which bone and cartilage plugs are taken from a cadaver donor and transplanted into the patient’s knee joint to stimulate growth of articular cartilage on the surface of the knee joint.

Osteochondral Autograft Transfer System (OATS)/Osteochondral Autograft Transplantation (OATS) and Mosaicplasty: Surgical procedures by which bone and cartilage plugs are taken from low weight bearing surfaces of the patient’s joint and inserted into the affected area of the same patient to stimulate growth of articular cartilage on the surface of the knee joint. This procedure is a technique for repairing articular cartilage that has been damaged by trauma. OATS involves transplanting one or more cartilage plugs and mosaicplasty involves transplanting several cartilage plugs.

Medical Policy Statement The Plan considers autologous chondrocyte transplantation (ACT), osteochondral autograft transplantation (OATS/mosaicplasty), or osteochondral allograft transplantation procedures to be medically necessary for osteochondral defects of the knee when the following applicable criteria are met and documented in the member’s medical record, as specified below in BOTH item 1 (member criteria) and item 2 (procedure-specific criteria):

1. Member Criteria:

ALL of the following member criteria are met, as specified below in items a through k:

a. Skeletally mature adult between 18 and 55 years of age on the date of service. If an adolescent member is evaluated, s/he should be skeletally mature with documented closure of growth plates (e.g., 15 years or older); AND

b. Not considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery; AND Osteochondral Treatments for Defects of the Knee

c. Persistent symptoms of disabling, localized knee pain have been present for at least six (6) months; AND

d. Failure to respond to at least (6) months of conservative treatment (e.g., physical therapy, braces, and/or non-steroidal anti-inflammatory drugs); AND

e. Body mass index (BMI) is less than or equal to 35 (for improved surgical outcomes by decreasing stress from weight-bearing on the joint); AND

f. Condition consists of a full-thickness cartilaginous defect (Grade III-IV) of the femoral condyle (medial, lateral or trochlea) caused by acute or repetitive trauma; acute trauma may result from falls, sports, and other sources of impact while repetitive trauma may include overuse; AND

g. Absence of knee osteoarthritis; AND

h. Absence of active infection; AND

i. Motivation and willingness to comply with a rigorous rehabilitation program; AND

j. No history of cancer in the bone, cartilage, fat or muscle of the treated limb; AND

k. All procedure-specific criteria are met, as specified below; AND

2. Procedure-Specific Criteria:

The applicable procedure-specific criteria are met, as specified below as item a, item b, or item c:

a. Autologous Chondrocyte Transplantation (ACT)/Autologous Chondrocyte Implantation (ACI):

ALL of the following criteria are met for autologous chondrocyte transplantation (ACT)/autologous chondrocyte implantation (ACI), as specified below in items (1) through (7):

(1) Inadequate response to prior arthroscopic or other surgical repair (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft); AND

(2) Cartilage defect of the femoral condyle measuring 1 to 12 cm squared (after debridement to healthy tissue); AND Osteochondral Treatments for Defects of the Knee

(3) Absence of generalized tibial chondromalacia; AND

(4) Absence of known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin; AND

(5) Absence of meniscal pathology; AND

(6) Stable and aligned knee (corrective procedures may be performed in combination with or prior to ACT); AND

(7) Normal articular cartilage at lesion border; OR

b. Osteochondral Allograft Transplantation:

ALL of the following criteria are met for osteochondral allograft transplantation, as specified below in items (1) through (4):

(1) Cartilage defect measuring greater than or equal to 2 cm squared; AND

(2) Stable knee with intact, fully functional menisci and ligaments; AND

(3) Normal knee alignment; AND

(4) Normal joint space; OR

c. Osteochondral Autograft Transplantation (OATS/Mosaicplasty):

ALL of the following criteria are met for osteochondral autograft transplantation (OATS/mosaicplasty), as specified below in items (1) through (4):

(1) Cartilage defect size is between 1.0 to 2.5 cm squared in total area; AND

(2) A stable knee with intact, fully functional menisci and ligaments; AND

(3) Normal knee alignment; AND

(4) Normal joint space

Osteochondral Treatments for Defects of the Knee

Limitations

1. Autologous chondrocyte transplantation (ACT), osteochondral allograft transplantation, or osteochondral autograft transplantation (OATS/mosaicplasty) is considered experimental and investigational for ANY of the following, as specified below in items a through c:

a. Treatment of a joint other than the knee or when Plan criteria are not met; OR

b. Treatment of patella lesions; OR

c. Treatment for a member less than age 15 (unless skeletally mature) or older than age 55 on the date of service.

2. The use of synthetic, resorbable polymers as bone filler material for osteochondral articular cartilage defects of the knee is considered experimental and investigational.

3. The use of minced articular cartilage for the repair of osteochondral articular cartilage defects of the knee is considered experimental and investigational.

Definitions Microfracture Surgery: Surgical procedure that can help restore knee cartilage by creating tiny fractures in the adjacent bones, causing new cartilage to develop.

Outerbridge Grading System: A common classification system used to describe a chondral injury; additional classification systems used to define chondral defects include the International Cartilage Repair Society (ICRS) classification and the Noyes classification. The Outerbridge grading system describes the arthroscopic appearance of cartilage wear. The compartmental wear of the joint space is more accurately assessed by combining the description of the damaged cartilage with the results of radiographic tests and magnetic resonance imaging (MRI). The Outerbridge grading system is classified as follows:

Grade Criteria for Outerbridge Grading System 0 Normal I Articular cartilage softening and swelling II Fragmentation and fissuring in an area less than 12 mm (half-inch) diameter III Fragmentation and fissuring in an area greater than 12 mm (half-inch) diameter IV Erosion of cartilage to subchondral bone

Osteochondral Treatments for Defects of the Knee

Applicable Coding The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Because the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service.

Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

CPT Codes Description: Codes Covered When Medically Necessary 27412 Autologous chondrocyte implantation, knee 27415 Osteochondral allograft, knee, open 27416 Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s]) 29866 Arthroscopy, knee, surgical; osteochondral autograft(s) (e.g., mosaicplasty) (includes harvesting of the autograft[s]) 29867 Arthroscopy, knee, surgical; osteochondral allograft (e.g., mosaicplasty)

HCPCS Codes Description: Codes Covered When Medically Necessary J7330 Autologous cultured chondrocytes, implant S2112 Arthroscopy, knee, surgical for harvesting of cartilage (chondrocyte cells)

CPT Code Description: Code Considered Experimental and Investigational 28446 Open osteochondral autograft, talus (includes obtaining grafts[s])

Osteochondral Treatments for Defects of the Knee

Clinical Background Information The knee joint is responsible for much of an individual’s weight bearing capability because of its location at the end of two long bones, the femur and the tibia. Weight is distributed throughout the knee joint and pressure is placed on the femoral condyles, trochlea and patella during flexion and extension. Hyaline cartilage covers the articular surface of the knee joints and plays a significant role in decreasing mechanical load and friction. Disabling knee joint function with pain and swelling can occur when the hyaline cartilage is damaged. In the skeletally mature individual, articular cartilage does not heal effectively when injured. Unsuccessful treatment can lead to progressive degenerative changes which may later require a total knee replacement. First line options for managing articular defects of the knee include procedures such as debridement, abrasion, arthroscopic subchondral drilling, and/or microfracture. All these standard therapies attempt to restore articular surface by inducing the growth of fibrocartilage into the chondral defect. If these techniques are unsuccessful, other options may include the use of autologous chondrocyte transplantation (ACT), osteochondral allograft transplantation, or osteochondral autograft transplantation (OATS/mosaicplasty) as a treatment to stimulate growth of articular cartilage. Each of these procedures is different and has its own specific indications.

Carticel®, Genzyme Corp. (Cambridge, MA) is the only FDA-approved cell-based ACT technology. Carticel® is indicated for the repair of symptomatic femoral condyle defects occurring on the medical, lateral, or trochlear weight-bearing surfaces that are caused by acute or repetitive trauma; ACT is used in patients who have failed prior arthroscopic or other surgical repair (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft) procedures. Carticel® is not FDA approved for use in pediatric patients; there is insufficient evidence on the safety or efficacy with children and skeletally immature adolescents. Cartricel® is also not FDA approved for use in adults over the age of 65 because of insufficient data of clinical efficacy.

Osteochondral allograft transplant, OATS, or mosaicplasty is indicated for a patient with a full-thickness cartilaginous defect (Grade III-IV) of the femoral condyle (medial, lateral or trochlea) caused by acute or repetitive trauma; a candidate for one of these procedures has had persistent, disabling localized knee pain for at least six (6) months and has failed to respond to conservative treatment (e.g., physical therapy, medications). The goal of each procedure is to resurface the affected area of the joint and improve the patient’s symptoms. Ideally, a candidate for any of the above three (3) procedures should have a stable and aligned knee and is willing and compliant with participation in a vigorous rehabilitation program. A history of osteoarthritis, active infection, or bone cancer in the affected limb is considered a contraindication for each of these procedures.

Synthetic resorbable polymers as bone void fillers or plugs (e.g., PolyGraft™ BGS, TruFit® [cylindrical plug], TruGraft™ [granules]) are available and have been proposed as bone graft substitute materials. Human studies are limited and poor clinical outcomes have been documented, including persistent pain, functional deficits, and failure of graft incorporation. The medical literature is insufficient to support the use of synthetic resorbable polymers for this indication.

Osteochondral Treatments for Defects of the Knee

Filling defects with minced articular cartilage (autologous or allogeneic) is being investigated for cartilage repair. Minced cartilage repair is a single-stage procedure that uses minced pieces of cartilage seeded over a scaffold (resorbable copolymer foam) or uses a fibrin adhesive layer (developed from cartilage tissue mixed with fibrin glue adhesive) which allows for even distribution of the chondrocytes to expand within the defect, providing structural and mechanical protection. The minced cartilage technique requires less donor tissue for the repair. Examples of this technology included the cartilage autograft implantation system (CAIS) developed by DePuy Mitek (Raynham, MA) and the DeNOVO NT Graft ("Natural Tissue Graft"; Zimmer Inc., Warsaw, IN/ISTO Technologies Inc. St Louis, MO), and BioCartilage from Arthrex Inc.). Additional clinical studies are needed to establish the safety and efficacy of minced cartilage repair.

Autologous chondrocyte transplantation (ACT), osteochondral autografts and allografts have been reported as a treatment for articular disorders other than the knee, including the ankle (talus), elbow, and shoulder. At the present time, the peer-reviewed scientific evidence is insufficient to permit conclusions about safety and efficacy of these procedures for use in joints other than the knee.

At the time of the Plan’s most recent policy review, no clinical guidelines were found from the Centers for Medicare & Medicaid Services (CMS) for osteochondral treatments of the knee, including autologous chondrocyte transplantation (ACT)/autologous chondrocyte implantation (ACI), osteochondral allograft transplantation, and osteochondral autograft transplantation (OATS/mosaicplasty). Determine if applicable CMS criteria are in effect for the specified service, product, and indication for treatment in a national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request for a Senior Care Options member.

References Alford JW, Cole BJ. Cartilage restoration, part 1. Basic science, historical perspective, patient evaluation, and treatment options. Am J Sports Med. 2005 Feb;33(2):295-306.

American Academy of Orthopaedic Surgeons (AAOS). Articular Cartilage Restoration. February 2009. Accessed at: http://orthoinfo.aaos.org/topic.cfm?topic=a00422

American Academy of Orthopaedic Surgeons (AAOS). Patellofemoral Arthritis. March 2011. Accessed at: http://orthoinfo.aaos.org/topic.cfm?topic=A00590

American Academy of Orthopaedic Surgeons (AAOS). Surgical Management of Articular Cartilage Defects in the Knee. Accessed at: http://www3.aaos.org/product/productpage.cfm?code=05054

Arthrex. BioCartilage®: Cartilage Extracellular Matrix. 2016. Accessed at: http://www.arthrex.com/orthobiologics/biocartilage-micronized-cartilage-matrix

Osteochondral Treatments for Defects of the Knee

Baums MH et al. Autologous Chondrocyte Transplantation for Treating Cartilage Defects of the Talus. Journal Bone & Joint Surg. Feb 2006;88-A(2):303-308.

Benthien JP, Schwaninger M, Behrens P. We do not have evidence based methods for the treatment of cartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. 2010 Nov 18. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/21085933

Bentley G et al. A prospective, randomised comparison of autologous chondrocyte implantation versus mosaicplasty for osteochondral defects in the knee. Journal of Bone & Joint Surgery - British Volume. 2003 Mar; 85(2):223-30.

Bhosale AM, Myint P, Roberts S, Menage J, Harrison P, Ashton B, Smith T, McCall I, Richardson JB. Combined autologous chondrocyte implantation and allogenic meniscus transplantation: a biological knee replacement. The Knee. 2007 Oct;14(5):361-8. Epub 2007 Aug 6. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/17689085

Brittberg M. Cell carriers as the next generation of cell therapy for cartilage repair: A review of the matrix-induced autologous chondrocyte implantation procedure. Am J Sports Med. 2010;38(6):1259- 1271.

Carticel. Is Carticel Right for Your Patient? Accessed at: http://www.carticel.com/healthcare/about/patient-assessment.aspx

Centers for Medicare & Medicaid Services (CMS). Welcome to the Medicare Coverage Database. Accessed at: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx

De Caro F, Bisicchia S, Amendola A, Ding L. Large Fresh Osteochondral Allografts of the Knee: A Systematic Clinical and Basic Science Review of the Literature. Arthroscopy. 2015 Feb 3. pii: S0749- 8063(14)00943-8. doi: 10.1016/j.

Ebert JR, Lloyd DG, Ackland T, Wood DJ. Knee biomechanics during walking gait following matrix- induced autologous chondrocyte implantation. Clin Biomech (Bristol, Avon). 2010;25(10):1011-1017.

Ebert JR, Robertson WB, Woodhouse J, et al. Clinical and magnetic resonance imaging-based outcomes to 5 years after matrix-induced autologous chondrocyte implantation to address articular cartilage defects in the knee. Am J Sports Med. 2011 Jan 21. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed?term=21257846

Food and Drug Administration (FDA) Product Approval Information for Autologous Cultured Chondrocytes. Carticel® (autologous cultured chondrocytes) for Implantation. Initial U.S. Approval 1997. Accessed at: http://www.fda.gov/downloads/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproduc ts/ucm109339.pdf Osteochondral Treatments for Defects of the Knee

Gardiner A, Weitzel PP. Bone graft substitutes in sports medicine. Sports Med Arthrosc Rev. 2007 Sep;15(3):158-66.

Genovese E, Ronga M, Angeretti MG, et al. Matrix-induced autologous chondrocyte implantation of the knee: Mid-term and long-term follow-up by MR arthrography. Skeletal Radiol. 2011;40(1):47-56.

Giza E, Sullivan M, Ocel D, et al. Matrix-induced autologous chondrocyte implantation of talus articular defects. Foot Ankle Int. 2010;31(9):747-753.

Görtz S, Bugbee WD. Allografts in articular cartilage repair. Instructional Course Lectures. 2007;56:469- 80. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/17472329/

Gross AE et al. Long-term followup of the use of fresh osteochondral allografts for posttraumatic knee defects. Clinical Orthopaedics & Related Research. 2005 Jun;(435):79-87.

Hayes Health Technology Brief. Osteochondral Allograft Transplantation for Articular Disorders of the Ankle. Winifred Hayes, Inc. April 15, 2013. Annual Review March 30, 2015.

Hayes Medical Technology Directory. Autologous Chondrocyte Implantation of the Knee. Winifred Hayes, Inc. July 15, 2013. Annual Review July 22, 2015.

Hayes Medical Technology Directory. Mosaicplasty. Winifred Hayes, Inc. April 13, 2012. Annual Review February 25, 2016.

Hennig A et al. Osteochondral allografts in the treatment of articular cartilage injuries of the knee. Sports Medicine & Arthroscopy Review. 2007 Sep; 15(3):126-32.

Horas U. et al. Autologous chondrocyte implantation and osteochondral cylinder transplantation in cartilage repair of the knee joint. A prospective, comparative trial. Bone Joint Surg Am. 2003 Dec;85- A(12):2487-8.

Jakobsen RB et al. An analysis of the quality of cartilage repair studies. Journal of Bone & Joint Surgery - American Volume. 2005 Oct;87(10):2232-9.

Jones, D.G., Petersen, L. Autologous Chondrocyte Implantation. 2007. Cartilage Repair Strategies, pages 137-165. Accessed at: http://www.springerlink.com/content/p65q34108qw46113/

Lynch TS, Patel RM, Benedick A, Amin NH, Jones MH, Miniaci A. Systematic Review of Autogenous Osteochondral Transplant Outcomes. Arthroscopy. 2015 Jan 20. pii: S0749-8063(14)00936-0.

Osteochondral Treatments for Defects of the Knee

McCormick F, Yanke A, Provencher MT, Cole BJ. Minced articular cartilage--basic science, surgical technique, and clinical application. Sports Med Arthrosc. 2008; 16(4):217-220.

National Institute for Health and Clinical Excellence (NICE). Mosaicplasty for knee cartilage defects. Interventional Procedure Guidance #162. March 2006. Updated January 20, 2012. Accessed at: http://guidance.nice.org.uk/IPG162

National Institute for Health and Clinical Excellence (NICE). The use of autologous chondrocyte implantation for the treatment of cartilage defects in knee joints. Technology Appraisal 89. May 2005. Updated April 30, 2012. Accessed at: http://guidance.nice.org.uk/TA89

Nagura I, Fujioka H, Kokubu T, Makino T, Sumi Y, Kurosaka M. Repair of osteochondral defects with a new porous synthetic polymer scaffold. The Journal of Bone and Joint Surgery, British Volume. 2007 Feb;89(2):258-64. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/17322449

Niederauer GG, Lee DR, Sankaran S. Bone grafting in arthroscopy and sports medicine. Sports Med Arthrosc. 2006 Sep;14(3):163-8.

Petersen, L., Vasiliadis, H.S., Brittberg, M., Lindahl, A. Autologous Chondrocyte Implantation: A Long- term Follow-up. American Journal of Sports Medicine. 2010. Volume 38(6), 1117-24. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/20181804.

Phillips BB. Osteochondral autografts. In: Canale ST, editor. Canale: Campbell's Operative Orthopaedics, 10th ed., Chapter 48, Arthroscopy of Lower Extremity. Osteochondral Dissecans of the Femoral Condyles. Copyright © 2003.

Schindler OS. Cartilage repair using autologous chondrocyte implantation techniques. J Perioper Pract. Feb 2009;19(2):60-4.

Simon TM et al. Articular cartilage: injury pathways and treatment options. Sports Medicine & Arthroscopy Review. 2006 Sep;14(3):146-54.

Washington State Department of Labor and Industries. Review criteria for knee surgery. Provider Bull 2003 Dec;(PB 03-16):1-7. Accessed at: http://www.lni.wa.gov/ClaimsIns/Files/OMD/MedTreat/KneeSurgery.pdf

Williams RJ et al. Fresh stored allografts for the treatment of osteochondral defects of the knee. Journal of Bone & Joint Surgery - American Volume. 2007 Apr; 89(4):718-26.

Zengerink M, Struijs PA, Tol JL, van Dijk CN. Treatment of osteochondral lesions of the talus: A systematic review. Knee Surg Sports Traumatol Arthrosc. 2010;18(2):238-246.

Osteochondral Treatments for Defects of the Knee

Original Effective Original Approval Date* and Version Policy Owner Approved by Date Number Regulatory Approval: N/A 11/01/08 Medical Policy Manager MPCTAC . QIC, and Version 1 as Chair of Medical Policy, Utilization Management Internal Approval: Criteria, and Technology Committee (UMC) 07/08/08: MPCTAC Assessment Committee 07/22/08: UMC (MPCTAC) 08/13/08: QIC and member of Quality Improvement Committee (QIC) *Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12 *Effective Date for the Well Sense Health Plan New Hampshire Medicaid Product(s): 01/01/13 *Effective Date for the Senior Care Options Product(s): 01/01/16

Policy Revisions History Revision Effective Date Review Date Summary of Revisions Approved by and Version Number 07/28/09 No changes except updated references. Version 2 07/28/09: MPCTAC 07/28/09: UMC 08/26/09: QIC 07/01/10 No changes except updated references. Version 3 08/18/10: MPCTAC 09/22/10: QIC 07/01/11 No changes except updated references. Version 4 08/17/11: MPCTAC 09/28/11: QIC 07/01/12 Updated references. No change made Version 5 07/18/12: MPCTAC to applicable code list. Revised list of 08/22/12: QIC conservative treatment options. Added language in clinical criteria that states

“acute trauma may result from falls, sports, and other sources of impact while repetitive trauma may include overuse.” Changed criteria for all three procedure types from “no history of bone cancer in the affected limb” to “no history of cancer in the bone, cartilage, fat, or muscle of the treated limb.” Added note in Description of Item or Service with recommendations on age and BMI of member seeking surgical procedure. Added language in Applicable Code section. 07/30/12 Off cycle review for Well Sense Health Version 6 08/03/12: MPCTAC Osteochondral Treatments for Defects of the Knee

Policy Revisions History Plan, revised Summary statement, 09/05/12: QIC reformatted Medical Policy Statement section, deleted reference to Carticel product. 07/01/13 Review for effective date 11/01/13. 11/01/13 07/17/13: MPCTAC Revised text in Description of Item or Version 7 08/15/13: QIC Service section. Removed duplicate text in the Clinical Background Information section and added information on Carticel®, minced cartilage repair, and synthetic resorbable polymers. Moved medical guidelines (related to skeletal maturing and BMI) from Description of Item or Service to the Medical Policy Statement section. Added medical criteria, limitations, and definition of Outerbridge Grading System. Updated references. 04/01/14 Review for effective date 08/01/14. 08/01/14 04/16/14: MPCTAC Revised Summary, Description of Item Version 8 05/14/14: QIC or Service, Definitions, and References sections. Revised criteria in the

Medical Policy Statement section. 03/01/15 Review for effective date 05/01/15. 05/01/15 03/18/15: MPCTAC Updated references. Removed Version 9 04/08/15: QIC Commonwealth Care, Commonwealth Choice, and Employer Choice from the list of applicable products because the products are no longer available. Administrative changes made to Medical Policy Statement section and Limitation section to clarify criteria. 11/25/15 Review for effective date 01/01/16. 01/01/16 11/18/15: MPCTAC Updated template with list of Version 10 11/25/15: MPCTAC applicable products and notes. (electronic vote) Revised language in the Applicable 12/09/15: QIC Coding section. 04/01/16 Review for effective date 06/01/16. 06/01/16 04/20/16: MPCTAC Updated Clinical Background Version 11 05/23/16: QIC Information, References, and Reference to Applicable Laws and Regulations.

Osteochondral Treatments for Defects of the Knee

Last Review Date 04/01/16

Next Review Date 04/01/17

Authorizing Entity QIC

Other Applicable Policies Medical Policy - Experimental and Investigational Treatment, policy number OCA 3.12 Medical Policy - Medically Necessary, policy number OCA 3.14

Reference to Applicable Laws and Regulations 78 FR 48164-69. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. August 7, 2013. Accessed at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

Disclaimer Information: + Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Osteochondral Treatments for Defects of the Knee