Integra® BioFix® Plus Amniotic Membrane Allograft

First published on 11/14/17 | Last updated on 6/30/19 | Literature review current through Dec. 2019 [cite]

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Technology and Product Assessment

Product Type: Acellular matrix

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® Plus Amniotic Allograft is a sterile human tissue allograft, derived from placental chrorionic membrane (allogeneic matrix).
INTENDED USES: For homologous use
CLAIMED FEATURES: Derived from human placental tissue. 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, to provide ideal graft handling, strength, and performance.

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® Plus 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 LifeSciences Corp.
Integra® BioFix® Plus 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

Integra® BioFix® Plus Amniotic Membrane Allograft

Coming soon

Product

Estimated
Out-of-pocket
Cost

Features

Integra® BioFix® Plus 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: Minimally manipulated Shelf life: Greater than 2 years Storage: room temp

CPT Code	Description	Physician Reimbursement - Office	Physician Reimbursement - Facility	Facility Reimbursement
15271	Application 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
15272	Application 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
15273	Application 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
15274	Application 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
15275	Application 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
15276	Application 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
15277	Application 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
15278	Application 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

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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Other related brands: PuraPly™ Antimicrobial, Per Square Centimeter, Cytal™ Burn Matrix, Integra® PriMatrix® Dermal Repair Scaffold, Per Square ..., Cytal® Wound Matrix 2-Layer 5 x 5 cm 1/box, Integra® Bilayer Wound Matrix (BWM), per sq cm, Oasis Wound Matrix, Per Square Centimeter, ArthroFLEX, per square centimeter, BIOVANCE® Human Amniotic Membrane Allograft, Per Square..., Cytal™ Wound Matrix (1-Layer, 2-Layer, 3-Layer, 6-Laye..., Cymetra, Injectable, 1cc, bio-ConneKt Wound Matrix, per square centimeter, Biobrane-L Temporary Wound Dressing, 5" x 5", Box of 5, Biobrane-L Temporary Wound Dressing, 5" x 12", Box of 5, Architect™ Stabilized Collagen Matrix, Per Square Centi..., Integra® BioFix® Flow Placental Tissue Matrix Allograft, Oasis Ultra Tri-Layer Matrix, Per Square Centimeter, Kerecis™ Omega3 Wound, Per Square Centimeter, Cytal® Wound Matrix 6-Layer 5 x 5 cm 1/box, Helicoll™, Per Square Centimeter, Integra® Omnigraft™ Dermal Regeneration Matrix, Per Squ..., Integra® Dermal Regeneration Template, Per Square Centi..., MIRODERM™ Fenestrated Plus Biologic Wound Matrix, Per S..., Integra® BioFix® Amniotic Membrane Allograft, MIRODERM™ Fenestrated Biologic Wound Matrix, Per Square..., PuraPly™, Per Square Centimeter (*), Cytal® Wound Matrix 3-Layer 5 x 5 cm 1/box, Interfyl Flowable Format, Biobrane-L Temporary Wound Dressing, 10" x 15", Box of ..., Hyalomatrix, per square centimeter, Integra® Wound Matrix, Per Square Centimeter, Cytal Wound Matrix 1-Layer, 3 x 3.5 cm, 1/box, Integra® Meshed Dermal Regeneration Template, Per Squar..., Interfyl Particulate, Integra® Meshed Bilayer Wound Matrix, Per Square Centim..., Keramatrix, Per Square Centimeter, Integra® Wound Matrix (Thin), Per Square Centimeter, MIRODERM™ Biologic Wound Matrix, Per Square Centimeter, MicroMatrix Micronized Particles 20 mg 1/box, Integra® Flowable Wound Matrix, Per Square Centimeter,

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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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.

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Integra® BioFix® Plus Amniotic Membrane Allograft

Integra® BioFix® Plus Amniotic Membrane Allograft

ESSENTIALS

CLINICAL

Indications

FDA

How supplied

CODING, COVERAGE AND REIMBURSEMENT

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