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Integra® BioFix® Amniotic Membrane Allograft

Integra® BioFix® Amniotic Membrane Allograft

Integra® BioFix® Amniotic Membrane Allograft

Technology and Product Assessment
Product Type: Acellular matrix
Other related products
Unbiased information for educational purposes only. WoundReference does not produce, market, advertise, re-sell or distribute healthcare goods or services consumed by, or used on patients.
Integra® BioFix® Amniotic Membrane Allograft is a human tissue allograft, derived from allogeneic dehydrated and decellularized amniotic membrane (allogeneic matrix).
INTENDED USES: It is intended for homologous use
CLAIMED FEATURES: Derived from human placental tissue and are offered in several sizes and volumes for use in a broad range of clinical applications. Carefully processed using HydraTek® technology, a proprietary process designed to preserve the natural structure and biological properties of the tissue
Manufacturer: Integra LifeSciences Corp.
Information retrieved from manufacturer and/or FDA-approved labels
* Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients. The product information contained on this page, including the product images and additional product materials, was collected from various supplier sources. All product claims and specifications are those of the product suppliers. Every effort has been made to ensure the accuracy of the product information, however on occasion manufacturers may alter their products or packaging without notice. Wound Reference assumes no liability for inaccuracies or misstatements about products. The properties of a product may change or be inaccurate following the posting or printing of the product information in the document, either in the print or online version. Due to product changes, information listed in this document is subject to change without notice. We recommend that you always read labels, warnings and instructions for use before using a product. Content on this site is for reference purposes and is not intended to be a substitute for professional advice given by a physician or other licensed healthcare professional.

ESSENTIALS

Product
Estimated
Out-of-pocket
Cost
HCPCS Class
HCPCS
Integra® BioFix® Amniotic Membrane Allograft
Skin substitute, not otherwise specified
Q4100
* Hover on the information button next to each header for detailed explanation on the type of information provided by the table
Choose the state for Medicare
DME coverage and co-payment
Product
Estimated
Out-of-pocket
Cost
Patient DME Co-Payment per Billable Unit
DME Reimbursement to Suppliers
Frequency Replacement if Requirements Met
Office and/or Facility - Product reimbursement
Integra® BioFix® Amniotic Membrane Allograft
$.00
(non-DMEPOS)
See Coding, Coverage and Reimbursement
* Every effort has been made to ensure the accuracy of the product information, however you should visit the manufacturer's website for the latest information.
* Hover on the information button next to each header for detailed explanation on the type of information provided by the table
Product
Estimated
Out-of-pocket
Cost
Recom / Evidence
FDA Safety
Quality Measures
Cost Effectiveness
Product
Estimated
Out-of-pocket
Cost
Features
Integra® BioFix® Amniotic Membrane Allograft
Composition: Human placenta or umbilical cord Configuration: Sheet May apply on full-thickness wounds May apply over exposed tendon/ bone/ muscle Processing: Dehydrated Processing: Minimally manipulated Shelf life: Greater than 2 years Storage: room temp
CPT CodeDescription Physician Reimbursement - Office Physician Reimbursement - Facility Facility Reimbursement
15271Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area. * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $145.08 $87.48 $1,568.43
15272Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $28.08 $18.36 $0.00
15273Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children. * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $309.24 $211.68 $2,710.48
15274Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) $73.08 $47.88 $0.00
15275Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area. * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $153.36 $99.00 $1,568.43
15276Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) $35.64 $26.28 $0.00
15277Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.* Facility reimbursement: For low cost skin substitute, refer to CPT codes C5271 to C5278 $338.40 $238.68 $1,568.43
15278Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) $87.48 $60.12 $0.00
C5271Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
C5273Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
C5274Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure)
C5275Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
C5272Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure)
C5276Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure)
C5277Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
C5278Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately with primary procedure)
  • Based on national averages
  • Medicare payments for participating qualified health professionals (QHP) for services performed in their Offices (*) or at a Facility (** i.e., hospital outpatient department or ambulatory service center). Payments are nationally unadjusted average amounts, and do not account for differences in payment due to geographic variation. The allowed rate for non-participating physicians is set at 95% of the allowable for participating physicians. Non-participating physicians are subject to the limiting charge rules. The coinsurance is limited to 20% of the allowable fee.
  • When covered by the Medicare contractor, this manufacturer product is separately payable in a QHP office based on the Average Sales Price (ASP) as reported by the manufacturer on a quarterly basis.
  • Hover on the information button next to each header for detailed explanation on the type of information provided by the table
  • The information provided on this website is informational only. This is not a guarantee of Reimbursement Rates, nor is it intended to make recommendations regarding clinical practices. Information on this website is subject to change with out notice due to changes in reimbursement laws, regulations, rules and policies. The ultimate responsibility for correct coding lies with the provider of services. Please contact the appropriate payer for their interpretation of the appropriate code to use for the procedure.
  • CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2018, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced on Wound Reference are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the American Medical Association prior to the submission of claims for reimbursement of covered services.
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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

  • 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