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National Coverage Determination (NCD)

Collagen Meniscus Implant

150.12

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Tracking Information

Publication Number
100-3
Manual Section Number
150.12
Manual Section Title
Collagen Meniscus Implant
Version Number
1
Effective Date of this Version
05/25/2010
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Physicians' Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.
Indications and Limitations of Coverage

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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
121
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R121NCD.pdf
Revision History

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
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Collagen Meniscus Implant 1 05/25/2010 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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