Meniscal Allografts and Other Meniscal Implants Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 10|02|2003 POLICY LAST REVIEWED: 05|07|2025 OVERVIEW Meniscal allografts and other meniscal implants (e.g., collagen) are intended to improve symptoms and reduce joint degeneration in individuals who have had a total or partial meniscus resection. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans and Commercial Products: Meniscal allograft transplantation: Meniscal allograft transplantation may be considered medically necessary in patients who have had a prior meniscectomy and have symptoms related to the affected side.
Meniscal allograft transplantation may be considered medically necessary when performed in combination, either concurrently or sequentially, with treatment of focal articular cartilage lesions. Collagen meniscal implants: Collagen meniscal implants are not covered for Medicare Advantage Plans and not medically necessary for Commercial products as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable surgery coverage/benefits.
BACKGROUND Meniscal allografts and other meniscal implants (e.g., collagen) are intended to improve symptoms and reduce joint degeneration in patients who have had a total or partial meniscus resection. Meniscal allograft transplantation may be considered medically necessary in individuals who have had a prior meniscectomy and have symptoms related to the affected side when all of the following criteria are met:
• Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., <55 years). • Disabling knee pain with activity that is refractory to conservative treatment. • Absence or near absence (>50%) of the meniscus, established by imaging or prior surgery. • Documented minimal to absent diffuse degenerative changes in the surrounding articular cartilage (e.g., Outerbridge grade II or less, < 50% joint space narrowing). • Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation. Meniscal allograft transplantation may be considered medically necessary when performed in combination, either concurrently or sequentially, with treatment of focal articular cartilage lesions using any of the following procedures:
Medical Coverage Policy | Meniscal Allografts and Other Meniscal Implants

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

• autologous chondrocyte implantation, or
• osteochondral allografting, or
• osteochondral autografting

MENISCAL CARTILAGE DAMAGE Meniscal cartilage is an integral structural component of the human knee, functioning to absorb shocks and providing load sharing, joint stability, congruity, proprioception, and lubrication and nutrition of the cartilage surfaces. Total and partial meniscectomy frequently result in degenerative osteoarthritis (OA). The integrity of the menisci is particularly important in knees in which the anterior cruciate ligament (ACL) has been damaged. In these situations, the menisci act as secondary stabilizers of anteroposterior and varus-valgus translation.

Treatment Meniscal allograft transplantation (MAT) is considered a salvage procedure, reserved for patients with disabling knee pain following meniscectomy who are considered too young to undergo total knee arthroplasty or in patients who require a total or near total meniscectomy for irreparable tears. As a result, the population intended to receive these transplants is relatively limited. Using a large database of privately insured non- Medicare patients, Cvetanovich et al (2015) estimated an annual incidence of MAT in the United States of 0.24 per 100,000. It is not expected that clinical trials will be conducted to compare meniscal allografts with other orthopedic procedures, although trials comparing allograft transplant with medical therapy are possible.

There are three general groups of patients who have been treated with MAT:

• young patients with a history of meniscectomy who have symptoms of pain and discomfort associated with early osteoarthritis that is localized to the meniscus-deficient compartment. • patients undergoing anterior cruciate ligament reconstruction in whom a concomitant meniscal transplant is intended to provide increased stability. • young athletes with few symptoms in whom the allograft transplantation is intended to deter the development of osteoarthritis. Due to the risks associated with this surgical procedure, prophylactic treatment for this purpose is not frequently recommended.

Issues under study include techniques for processing and storing the grafts, proper sizing of the grafts, and appropriate surgical techniques. The four primary ways of processing and storing allografts are fresh viable, fresh frozen, cryopreserved, and lyophilized. Fresh viable implants, harvested under sterile conditions, are less frequently used because the grafts must be used within a couple of days to maintain viability. Alternatively, the harvested meniscus can be fresh frozen for storage until needed. Cryopreservation freezes the graft in glycerol, which aids in preserving the cell membrane integrity and donor fibrochondrocyte viability. CryoLife is a commercial supplier of such grafts. Donor tissues may also be dehydrated (freeze-dried or lyophilized), permitting storage at room temperature. Lyophilized grafts are prone to reduced tensile strength, shrinkage, poor rehydration, posttransplantation joint effusion, and synovitis; these are no longer used in the clinical setting. Several secondary sterilization techniques may be used, with gamma irradiation the most common. The dose of radiation considered effective has been shown to change the mechanical structure of the allograft; therefore, nonirradiated grafts from screened donors are most frequently used. In a survey conducted by the International Meniscus Reconstruction Experts Forum, when surgeons were asked about allograft preference, 68% preferred fresh frozen nonirradiated allografts, with 14% responding fresh viable allografts.

There are several techniques for MAT; most are arthroscopically assisted or all-arthroscopic. Broadly, the techniques are either all-suture fixation or bone fixation. Within the bone fixation category, the surgeon may use either bone plugs or a bone bridge. Types of bone bridges include keyhole, trough, dove-tail, and bridge- in-slot. The technique used depends on laterality and the need for concomitant procedures. Patients with malalignment, focal chondral defects, and/or ligamentous insufficiency may need concomitant procedures (osteotomy, cartilage restoration, and/or ligament reconstruction, respectively.)

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

Tissue engineering that grows new replacement host tissue is also being investigated. For example, the Collagen Meniscus Implant (CMI®) (by Stryker, formerly the ReGen Collagen Scaffold® by ReGen Biologics is a resorbable collagen matrix composed primarily of type I collagen from bovine Achilles tendons. The implant is provided in a semilunar shape and trimmed to size for suturing to the remaining meniscal rim. The implant provides an absorbable collagen scaffold that is replaced by the patient’s soft tissue; it is not intended to replace normal body structure. Because it requires a meniscal rim for attachment, it is intended to fill meniscus defects after a partial meniscectomy. A second collagen meniscus implant, RejuvaKnee™ has similar characteristics to CMI; however, the bovine collagen is sourced from the meniscus as opposed to the Achilles tendon. Other scaffold materials and cell-seeding techniques are being investigated. Nonabsorbable and nonporous synthetic implants for total meniscus replacement are in development. One total meniscus replacement that is in early phase clinical testing is NUsurface® (Active Implants); it is composed of a polyethylene reinforced polycarbonate urethane.

Outcome Measures
The outcomes of this treatment (ie, pain, functional status) are subjective, patient-reported outcomes that are prone to placebo effects. On the other hand, the natural history of a severely damaged meniscus is predictable, with progressive joint damage, pain, and loss of function.

REGULATORY STATUS
Collagen Meniscus Implants
In 2008, the ReGen Collagen Scaffold was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing absorbable surgical mesh devices. The ReGen Collagen Scaffold (also known as MenaFlexTM CMI) was the only collagen meniscus implant with the FDA clearance at that time. Amid controversy about this 510(k)-clearance, the FDA reviewed its decision. In October 2010, the FDA rescinded the approval, stating that MenaFlex is intended for different purposes and is technologically dissimilar from the predicate devices identified in the approval process. The manufacturer appealed the rescission and won its appeal in 2014. The product, now called CMI, was manufactured by Ivy Sports Medicine (now Stryker). A second collagen meniscus implant, RejuvaKnee™ (Collagen Matrix, Inc [now Regenity]), was declared substantially equivalent to CMI by the FDA in 2024.

For individuals who are undergoing partial meniscectomy who receive meniscal allograft transplantation (MAT), the evidence includes systematic reviews of mostly case series and a randomized control trial (RCT). Relevant outcomes are symptoms, functional outcomes, and quality of life. The systematic reviews concluded that most studies have shown statistically significant improvements in pain and function following the procedure. The benefits have also been shown to have a long-term effect (>10 years). Reviews have also reported acceptable complication and failure rates. There remains no evidence that MAT can delay or prevent the development of knee osteoarthritis. A limitation of the evidence is its reliance primarily on case series. Because the results of the single RCT, which enrolled a very small number of patients, pooled data from randomized and nonrandomized groups, results cannot be interpreted in a meaningful way. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are undergoing partial meniscectomy and concomitant repair of malalignment, focal chondral defects, and/or ligamentous insufficiency who receive MAT, the evidence includes a systematic review of case series as well as case series published after the systematic review. Relevant outcomes are symptoms, functional outcomes, and quality of life. The systematic review concluded that pain and function improved following the procedure. One of the series published after the review showed that patients with more severe cartilage damage experienced favorable outcomes similar to patients with less cartilage damage. Another series published subsequently reported an overall 9.7-year survival of the implant. A limitation of the evidence is its reliance primarily on case series. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

For individuals who are undergoing partial meniscectomy who receive collagen meniscal implants (CMIs), the evidence includes several systematic reviews primarily of case series. Relevant outcomes are symptoms, functional outcomes, and quality of life. The reviews reported overall positive results with the CMI but the quality of the selected studies (RCTs, observational studies) was low. Radiologic evaluations have shown reductions in the size of the implant in a large portion of patients. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products: The following CPT code may be considered medically necessary when reported with a diagnosis code listed below:
29868 Arthroscopy, knee, surgical; Meniscal transplantation (includes arthrotomy for meniscal insertion),

         medial or lateral

ICD-10-CM Diagnosis Codes that may support medical necessity:
M23.000-M23.92 S83.200-S83.289 S83.30-S83.32

The following HCPCS code is not covered for Medicare Advantage Plans and not medically necessary for Commercial products: G0428 Collagen Meniscus Implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex)

RELATED POLICIES Not applicable

PUBLISHED Provider Update, July 2025 Provider Update, August, 2024 Provider Update, August 2023 Provider Update, September 2022 Provider Update, June 2021

REFERENCES:

1. Cvetanovich GL, Yanke AB, McCormick F, et al. Trends in Meniscal Allograft Transplantation in the United States, 2007 to 2011. Arthroscopy. Jun 2015; 31(6): 1123-7. PMID 25682330
2. Getgood A, LaPrade RF, Verdonk P, et al. International Meniscus Reconstruction Experts Forum (IMREF) 2015 Consensus Statement on the Practice of Meniscal Allograft Transplantation. Am J Sports Med. May 2017; 45(5): 1195-1205. PMID 27562342
3. Frank RM, Cole BJ. Meniscus transplantation. Curr Rev Musculoskelet Med. Dec 2015; 8(4): 443-50. PMID 26431702
4. Elattar M, Dhollander A, Verdonk R, et al. Twenty-six years of meniscal allograft transplantation: is it still experimental? A meta-analysis of 44 trials. Knee Surg Sports Traumatol Arthrosc. Feb 2011; 19(2): 147-57. PMID 21161170
5. Hergan D, Thut D, Sherman O, et al. Meniscal allograft transplantation. Arthroscopy. Jan 2011; 27(1): 101-12. PMID 20884166
6. Rosso F, Bisicchia S, Bonasia DE, et al. Meniscal allograft transplantation: a systematic review. Am J Sports Med. Apr 2015; 43(4): 998-1007. PMID 24928760
7. Smith NA, Parsons N, Wright D, et al. A pilot randomized trial of meniscal allograft transplantation versus personalized physiotherapy for patients with a symptomatic meniscal deficient knee compartment. Bone Joint J. Jan 2018; 100-B(1): 56-63. PMID 29305451

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

8. Verdonk PC, Demurie A, Almqvist KF, et al. Transplantation of viable meniscal allograft. Survivorship analysis and clinical outcome of one hundred cases. J Bone Joint Surg Am. Apr 2005; 87(4): 715-24. PMID 15805198
9. Hommen JP, Applegate GR, Del Pizzo W. Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy. Apr 2007; 23(4): 388-93. PMID 17418331
10. van der Wal RJ, Thomassen BJ, van Arkel ER. Long-term clinical outcome of open meniscal allograft transplantation. Am J Sports Med. Nov 2009; 37(11): 2134-9. PMID 19542303
11. Vundelinckx B, Bellemans J, Vanlauwe J. Arthroscopically assisted meniscal allograft transplantation in the knee: a medium-term subjective, clinical, and radiographical outcome evaluation. Am J Sports Med. Nov 2010; 38(11): 2240-7. PMID 20724642
12. 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. Mar 2011; 27(3): 409-18. PMID 21030203
13. Stone KR, Adelson WS, Pelsis JR, et al. Long-term survival of concurrent meniscus allograft transplantation and repair of the articular cartilage: a prospective two- to 12-year follow-up report. J Bone Joint Surg Br. Jul 2010; 92(7): 941-8. PMID 20595111
14. Farr J, Rawal A, Marberry KM. Concomitant meniscal allograft transplantation and autologous chondrocyte implantation: minimum 2-year follow-up. Am J Sports Med. Sep 2007; 35(9): 1459-66. PMID 17435058
15. Rue JP, Yanke AB, Busam ML, et al. Prospective evaluation of concurrent meniscus transplantation and articular cartilage repair: minimum 2-year follow-up. Am J Sports Med. Sep 2008; 36(9): 1770-8. PMID 18483199
16. Kempshall PJ, Parkinson B, Thomas M, et al. Outcome of meniscal allograft transplantation related to articular cartilage status: advanced chondral damage should not be a contraindication. Knee Surg Sports Traumatol Arthrosc. Jan 2015; 23(1): 280-9. PMID 25432522
17. Ogura T, Bryant T, Minas T. Biological Knee Reconstruction With Concomitant Autologous Chondrocyte Implantation and Meniscal Allograft Transplantation: Mid- to Long-term Outcomes. Orthop J Sports Med. Oct 2016; 4(10): 2325967116668490. PMID 27803938
18. Zaffagnini S, Grassi A, Marcheggiani Muccioli GM, et al. Survivorship and clinical outcomes of 147 consecutive isolated or combined arthroscopic bone plug free meniscal allograft transplantation. Knee Surg Sports Traumatol Arthrosc. May 2016; 24(5): 1432-9. PMID 26860105
19. Harston A, Nyland J, Brand E, et al. Collagen meniscus implantation: a systematic review including rehabilitation and return to sports activity. Knee Surg Sports Traumatol Arthrosc. Jan 2012; 20(1): 135-
20. PMID 21695465
21. Warth RJ, Rodkey WG. Resorbable collagen scaffolds for the treatment of meniscus defects: a systematic review. Arthroscopy. May 2015; 31(5): 927-41. PMID 25595693
22. Zaffagnini S, Grassi A, Marcheggiani Muccioli GM, et al. MRI evaluation of a collagen meniscus implant: a systematic review. Knee Surg Sports Traumatol Arthrosc. Nov 2015; 23(11): 3228-37. PMID 24993568
23. Houck DA, Kraeutler MJ, Belk JW, et al. Similar clinical outcomes following collagen or polyurethane meniscal scaffold implantation: a systematic review. Knee Surg Sports Traumatol Arthrosc. Aug 2018; 26(8): 2259-2269. PMID 29340746
24. Han JH, Jung M, Chung K, et al. Clinical Impact of Meniscal Scaffold Implantation in Patients with Meniscal Tears: A Systematic Review. Clin Orthop Surg. Feb 2025; 17(1): 112-122. PMID 39912078
25. Rodkey WG, DeHaven KE, Montgomery WH, et al. Comparison of the collagen meniscus implant with partial meniscectomy. A prospective randomized trial. J Bone Joint Surg Am. Jul 2008; 90(7): 1413-26. PMID 18594088
26. Linke RD, Ulmer M, Imhoff AB. Replacement of the meniscus with a collagen implant (CMI). Oper Orthop Traumatol. Dec 2006; 18(5-6): 453-62. PMID 17171330
27. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, et al. Prospective long-term outcomes of the medial collagen meniscus implant versus partial medial meniscectomy: a minimum 10-year follow-up study. Am J Sports Med. May 2011; 39(5): 977-85. PMID 21297005

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

27. Bulgheroni E, Grassi A, Bulgheroni P, et al. Long-term outcomes of medial CMI implant versus partial medial meniscectomy in patients with concomitant ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. Nov 2015; 23(11): 3221-7. PMID 24990662
28. American Academy of Orthopaedic Surgeons. Acute Isolate Meniscal Pathology. 2024; https://www.aaos.org/globalassets/quality-and-practice-resources/acute-meniscal-pathology/amp- cpg.pdf. Accessed February 27, 2025.
29. National Institute for Health and Care Excellence (NICE). Partial replacement of the meniscus of the knee using a biodegradable scaffold: guidance [IPG430]. 2012; https://www.nice.org.uk/guidance/IPG430. Accessed February 27, 2025.

30. Centers for Medicare and Medicaid Services (CMS). Decision Memo for COLLAGEN MENISCUS IMPLANT (CAG-00414N). 2010; https://www.cms.gov/medicare-coverage-database/details/nca- decision-memo.aspx?NCAId=235. Accessed February 27, 2025.

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