Last updated on 12/3/24 | First published on 11/15/17 | Literature review current through Nov. 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.
DermaPure® Decellularized Dermal Allograft is decellularized human dermis (acellular matrix).
INTENDED USES: Used to manage a patient's soft tissue defects. Intended to be used to provide reinforcement, repair, or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. For traumatic injuries, surgical dehiscence, necrotizing fasciitis, cancerous lesion resection, pilonidal cysts, diabetic limb salvage, head/neck reconstruction, hidradenitis suppurativa and chronic wounds.
CLAIMED FEATURES: 99% DNA-free decellularized human dermis. Intact vascular-like channels and native growth factors stimulate revascularization and signal a biologic response for wound healing.
OPTIONS: Per Square Centimeter
Manufacturer: Tissue Regenix Wound Care, Inc.
Information retrieved from manufacturer and/or FDA-approved labels
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ESSENTIALS
Product
Estimated
Out-of-pocket
Cost
HCPCS Class
HCPCS
Dermapure, per square centimeter
Q4152
* 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
* 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 dermis with/without epidermis
Configuration: Sheet
May apply on full-thickness wounds
May apply over exposed tendon/ bone/ muscle
Processing: Decellularized or irradiated
Processing: Minimally manipulated
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.
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CLINICAL
Indications
DermaPure® Decellularized Dermal Allogra provides a scaffold for the body’s repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
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. The basic functions of skin include covering, protecting the body from external force, and serving as a water-resistant barrier to pathogens or other damaging agents in the external environment. The dermis is the elastic connective tissue layer of the skin that covers, provides support and protects the body from mechanical stress. Human skin allografts used for supplemental support, protection, reinforcement, or covering for wounds, tendon, muscle, bones are considered homologous use. [1]
How supplied
- 010200HD: 1 cm x 2 cm DermaPure Decellularized Dermal Allograft: Q4152
- 020200HD: 2 cm x 2 cm DermaPure Decellularized Dermal Allograft: Q4152
- 020300HD: 2 cm x 3 cm DermaPure Decellularized Dermal Allograft: Q4152
- 030400HD: 3 cm x 4 cm DermaPure Decellularized Dermal Allograft: Q4152
- 040600HD: 4 cm x 6 cm DermaPure Decellularized Dermal Allograft: Q4152
- 071000HD: 7 cm x 10 cm DermaPure Decellularized Dermal Allograft: Q4152
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. CGS Administrators, LLC First Coast Service Options, Inc. (FCSO) 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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