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Integra® BioFix® Amniotic Membrane Allograft

Integra® BioFix® Amniotic Membrane Allograft

Integra® BioFix® Amniotic Membrane Allograft

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

  • BF24045: BioFix Membrane, 2 x 4 cm
  • BF44045: BioFix Membrane, 4 x 4 cm
  • BF46045: BioFix Membrane, 4 x 6 cm
  • BF48045: BioFix Membrane, 4 x 8 cm
  • HCPCS: Q4100 (when used as a skin substitute)


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. 

Medicare hospital outpatient prospective payment system (OPPS) cost category assignment:

  • CY 2019: low cost

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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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.
Topic 295 Version 1.0