Last updated on 11/10/22 | First published on 11/14/17 | Literature review current through Oct. 2022
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CLINICAL
Indications
Integra® BioFix® and Integra® BioFix® Plus (BioFix) are sterile, human tissue allografts, derived from allogeneic dehydrated and decellularized amniotic membrane. BioFix is intended for homologous use as a wound covering for surgical sites, voids, and tissue defects.
FDA
Regulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps.
How supplied
- BF24200: BioFix Plus Membrane, 2 x 4 cm: Q4100
- BF44200: BioFix Plus Membrane, 4 x 4 cm: Q4100
- BF46200: BioFix Plus Membrane, 4 x 6 cm: Q4100
- BF48200: BioFix Plus Membrane, 4 x 8 cm: Q4100
CODING, COVERAGE AND REIMBURSEMENT
This section currently focuses primarily on Medicare. It may be expanded in the future to include information on private insurers as well.
Frequency of replacement allowed by Medicare:
| Medicare Administrative Contractor (MAC) |
Frequency of replacement if requirements met |
| Novitas Solutions, Inc. |
10 units in 12 weeks |
| CGS Administrators, LLC |
10 units in 12 weeks |
| Palmetto |
10 units in 12 weeks |
| First Coast Service Options, Inc. (FCSO) |
1 type of product per 12 weeks, fewest repeat applications and amount of product is expected
|
|
Noridian
Wisconsin Physicians Service Insurance Corporation (WPS)
National Government Services, Inc. (NGS)
|
Carrier discretion
|
More details on requirements, medical necessity and documentation in specific Medicare Local Coverage Determinations (if available). See section on Coding, Coverage and Reimbursement in topic "Cellular and/or Tissue Products".
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