Last updated on 6/30/19 | First published on 11/14/17 | Literature review current through Jun. 2022
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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. For information about specific products, please contact the manufacturer directly.
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
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ESSENTIALS
Product
Estimated
Out-of-pocket
Cost
HCPCS Class
HCPCS
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
Select your 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
$.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
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 | Skin sub graft trnk/arm/leg |
$159.88
|
$85.13
|
$1,749.26
|
| 15272 | Skin sub graft t/a/l add-on |
$25.95
|
$18.00
|
|
| 15273 | Skin sub grft t/arm/lg child |
$327.72
|
$201.41
|
$3,596.22
|
| 15274 | Skn sub grft t/a/l child add |
$86.86
|
$46.37
|
|
| 15275 | Skin sub graft face/nk/hf/g |
$164.38
|
$94.82
|
$1,749.26
|
| 15276 | Skin sub graft f/n/hf/g addl |
$33.57
|
$25.95
|
|
| 15277 | Skn sub grft f/n/hf/g child |
$359.56
|
$229.44
|
$1,749.26
|
| 15278 | Skn sub grft f/n/hf/g ch add |
$100.36
|
$57.79
|
|
- 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.
* Scroll table to see all products.
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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