CMS Collagen Meniscus Implant Coverage Policy: What Billing Teams Need to Know in 2026
CMS has issued a modified policy determination under NCD 337 covering the collagen meniscus implant (CMI), a bovine collagen scaffold used to fill meniscal defects following partial meniscectomy. While the underlying non-coverage determination dates back to May 2010, this 2026 modification formally updates the policy record—making it critical for orthopedic billing teams to confirm their claims processes reflect the absolute coverage exclusion that has been in place for over a decade. If your practice performs knee arthroscopy with meniscal repair, this policy directly affects how you document, code, and appeal any related claims.
| Field | Detail |
|---|---|
| Payer | Centers for Medicare & Medicaid Services (CMS) |
| Policy | Collagen Meniscus Implant |
| Policy Code | NCD 337 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | Medium |
| Specialties Affected | Orthopedic Surgery, Sports Medicine, Orthopedic Billing & RCM |
| Key Action | Confirm all CMI claims for Medicare beneficiaries are flagged as non-covered and that no authorization requests are being submitted for this procedure. |
What Is the Collagen Meniscus Implant — and Why Does CMS Exclude It?
The collagen meniscus implant—also referred to in clinical literature as a collagen scaffold (CS), CMI, or Menaflex™ meniscus implant—is a tissue-engineered device designed to fill meniscal defects after partial meniscectomy. It is manufactured from bovine collagen and placed arthroscopically, with an additional incision used to capture repair needles and tie sutures.
After debridement of the damaged meniscus, the implant is trimmed to match the size of the defect and sutured to the remaining meniscal rim. This is a key structural detail: the CMI requires an intact meniscal rim for attachment and is not intended to replace the entire meniscus. It should not be confused with meniscal transplant procedures involving cadaver donor tissue—those are addressed separately and are not covered under NCD 337.
CMS reviewed the clinical evidence and concluded, effective May 25, 2010, that the collagen meniscus implant does not improve health outcomes. Under section 1862(a)(1)(A) of the Social Security Act, services that are not reasonable and necessary for the treatment of an illness or injury are excluded from Medicare coverage. The CMI has carried that designation for 15 years—and the 2026 policy modification reaffirms that non-coverage status remains in effect.
CMS Medical Necessity Determination: Coverage vs. Non-Coverage Under NCD 337
Understanding the structure of NCD 337 matters for billing teams managing Medicare claims, appeals, and Advance Beneficiary Notice (ABN) workflows.
Nationally Covered Indications: None. CMS has not identified any clinical scenario in which the collagen meniscus implant is covered for Medicare beneficiaries.
Nationally Non-Covered Indications: All uses of the collagen meniscus implant for the treatment of meniscal injury or tear are non-covered, effective for dates of service on or after May 25, 2010. There are no exceptions, no diagnosis-specific carve-outs, and no prior authorization pathway that results in coverage. The evidence review concluded that the implant simply does not improve health outcomes at a standard sufficient to meet Medicare's reasonable and necessary threshold.
Scope of the NCD: This determination covers the CMI itself as placed during arthroscopic knee procedures. The policy explicitly does not address meniscal transplant using cadaveric tissue—practices performing those procedures should reference separate policy guidance.
This is a binary policy: there are no covered indications to document toward, and no medical necessity criteria that unlock reimbursement. Any claim submitted for a CMI procedure on a Medicare beneficiary will deny.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
This policy does not list specific CPT, HCPCS, or ICD-10 codes in its code table. Practices should work with their orthopedic coding team to identify the arthroscopic procedure codes associated with collagen meniscus implant placement at their facility—and confirm those codes are flagged appropriately in your claim editing system for Medicare payers.
If you are submitting claims that include the CMI as part of a broader arthroscopic knee procedure, documentation must clearly distinguish the covered components of the procedure from the non-covered CMI placement. Bundling a non-covered service with covered services without appropriate modifier use or ABN documentation creates compliance exposure.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit active Medicare claim queues immediately. Search your billing system for any pending or recently submitted claims that include documentation of collagen meniscus implant placement for Medicare beneficiaries. Any claim that reaches an adjudicator without proper handling will deny—and repeated submissions without correction can trigger medical review activity. |
| 2 | Update your charge capture and claim editing rules by March 12, 2026. Given the policy modification date, confirm your revenue cycle management system and claim scrubber reflect the absolute non-coverage status of the CMI under Medicare. If your system relies on code-level edits, work with your coding team to map the relevant arthroscopic procedure codes to an NCD 337 non-coverage flag. |
| 3 | Issue Advance Beneficiary Notices before any CMI procedure on a Medicare patient. Because this is a nationally non-covered service with no pathway to coverage, a properly executed ABN is required before the procedure if you want any ability to bill the patient. The ABN must explain that Medicare will not pay, state the estimated cost, and document the patient's choice. Without a valid ABN, the practice absorbs the cost entirely. |
| 4 | Educate your orthopedic surgeons and clinical documentation team on the non-coverage designation. Physicians sometimes assume that newer or adjunctive surgical techniques will be covered by default. NCD 337 is an explicit national prohibition—no amount of clinical documentation or appeal narrative will overturn a non-covered NCD determination at the MAC level. |
| 5 | Review any open appeals involving CMI claims. If your practice has submitted appeals on denied CMI claims, assess whether those appeals have a viable basis. Appeals cannot override a non-covered NCD determination through medical necessity arguments. Redirection of appeal resources toward recoverable denials is the better use of staff time. |
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