Collagen Meniscus Implant

A. General

The knee menisci are wedge-shaped, semi-lunar discs of fibrous tissue located in the knee joint between the ends of the femur and the tibia and fibula. There is a lateral and medial meniscus in each knee. It is known now that the menisci provide mechanical support, localized pressure distribution, and lubrication of the knee joint. Initially, meniscal tears were treated with total meniscectomy; however, as knowledge of the function of the menisci and the potential long term effects of total meniscectomy on the knee joint evolved, treatment of symptomatic meniscal tears gravitated to repair of the tear, when possible, or partial meniscectomy.

The collagen meniscus implant (also referred to as collagen scaffold (CS), CMI or Menaflex™ meniscus implant throughout the published literature) is used to fill meniscal defects that result from partial meniscectomy. The collagen meniscus implant is not intended to replace the entire meniscus at it requires a meniscal rim for attachment. The literature describes the placement of the collagen meniscus implant through an arthroscopic procedure with an additional incision for capture of the repair needles and tying of the sutures. After debridement of the damaged meniscus, the implant is trimmed to the size of meniscal defect and sutured into place. The collagen meniscus implant is described as a tissue engineered scaffold to support the generation of new meniscus-like tissue. The collagen meniscus implant is manufactured from bovine collagen and should not be confused with the meniscus transplant which involves the replacement of the meniscus with a transplant meniscus from a cadaver donor. The meniscus transplant is not addressed under this national coverage determination.

B. Nationally Covered Indications

N/A

C. Nationally Non-Covered Indications

Effective for claims with dates of service performed on or after May 25, 2010, the Centers for Medicare & Medicaid Services has determined that the evidence is adequate to conclude that the collagen meniscus implant does not improve health outcomes and, therefore, is not reasonable and necessary for the treatment of meniscal injury/tear under section 1862(a)(1)(A) of the Social Security Act. Thus, the collagen meniscus implant is non-covered by Medicare.

D. Other

N/A

(This NCD last reviewed May 2010.)

05/2010 - Upon completion of a national coverage analysis for the collagen meniscus implant, the decision was made that the collagen meniscus implant is non-covered for Medicare beneficiaries. Effective date: 05/25/2010 TN 121