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October 29, 2020

Use of Human Amniotic Based Products

CGS has seen multiple claims where cellular and/or tissue-based products (CTPs), specially micronized or particulated human amniotic membrane and/or placental tissue matrix, are being injected into joints and tissues for osteoarthritis, plantar fasciitis, and other complaints. The labeled indications for these products are to treat non-healing wounds and burn injuries and are intended for external application to the wound. CGS covers the application of CTPs for ulcers or wounds as outlined in the LCD L36690 Wound Application of Cellular and/or Tissue-Based Products, Lower extremities. Use of these products topically or as an injection outside of the labeled use and as defined in L36690 is considered off-labeled and may not be a covered service.

Off label usage may be reviewed pre-pay or on appeal. The appeal request should include medical record documentation supporting the unique usage and include full-text copies of evidence-based, peer-reviewed articles from core medical journals supporting such use. Such articles should include the results of robust CMS and/or FDA approved clinical trials and/or meta-analysis that support any additional indications.

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