Last updated on 8/23/23 | First published on 11/14/17 | Literature review current through Oct. 2024
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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.
AMNIOEXCEL® Amniotic Allograft Membrane is a human placental-based tissue product (allogeneic matrix).
INTENDED USES: Helps provide an environment to repair, reconstruct, and replace tissue. It is intended for homologous use as a wound covering to aid in closing chronic wounds.
CLAIMED FEATURES: It is a human placental-based tissue product processed using a proprietary method. The membrane acts as protective covering when placed over the wound, providing the key components found in human amnion including an intact extracellular matrix (ECM), growth factors, and cytokines. Easily molds and conforms to the wound, and helps provide an environment to repair, reconstruct, and replace tissue. Minimally manipulated amniotic membrane donated by pre-screened mothers during planned C-sections. The membrane is dehydrated using the DryFlex™ process which keeps the tissue intact and malleable, gives it a five year shelf life at room temperature and retains the key components of human amnion. It is intended for homologous use as a wound covering to aid in closing chronic wounds.
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
Amnioexcel, amnioexcel plus or biodexcel, per square centimeter
Q4137
* 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
per square centimeter (non-DMEPOS)
See Coding, Coverage and Reimbursement
$111.06
* 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: Dehydrated
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
AMNIOEXCEL® is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician.
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. Among other criteria, HCT/Ps are required to be minimally manipulated and intended for homologous use. Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. [1] In the case of amniotic membranes, homologous use include serving as a selective barrier, protection and covering of a wound.
How supplied
- 25012: AMNIOEXCEL® Human Amniotic Membrane Allograft, 12 mm disk 1cm2: Q4137
- 25013: AMNIOEXCEL® Human Amniotic Membrane Allograft, 15 mm disk 2cm2: Q4137
- 25018: AMNIOEXCEL® Human Amniotic Membrane Allograft, 18 mm disk 3cm2: Q4137
- 25024: AMNIOEXCEL® Human Amniotic Membrane Allograft, 24 mm disk 5cm2: Q4137
- 25015: AMNIOEXCEL® Human Amniotic Membrane Allograft, 1.5 cm x 1.5 cm 2cm2: Q4137
- 25023: AMNIOEXCEL® Human Amniotic Membrane Allograft, 2.0 cm x 3.0 cm 6cm2: Q4137
- 25035: AMNIOEXCEL® Human Amniotic Membrane Allograft, 3.5 cm x 3.5 cm 12cm2: Q4137
- 25044: AMNIOEXCEL® Human Amniotic Membrane Allograft, 4.0 cm x 4.0 cm 16cm2: Q4137
- 25048: AMNIOEXCEL® Human Amniotic Membrane Allograft, 4.0 cm x 8.0 cm 32cm2: Q4137
- 25055: AMNIOEXCEL® Human Amniotic Membrane Allograft, 5.0 cm x 5.0 cm 25cm2: Q4137
- 25110: AMNIOEXCEL® Human Amniotic Membrane Allograft, 10.0 cm x 10.0 cm 100 cm2: Q4137
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:
Frequency of replacement allowed by Medicare:
| Medicare Administrative Contractor (MAC) | Frequency of replacement if requirements met |
| Novitas Solutions, Inc. | Non-covered by CMS |
| CGS Administrators, LLC | Non-covered by CMS |
| First Coast Service Options, Inc. (FCSO) | Non-covered by CMS |
Palmetto
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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