Last updated on 10/1/23 | First published on 11/10/17 | 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.
TheraSkin is a biologically active, cryopreserved human skin allograft.
INTENDED USES: TheraSkin may be used in diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. It is esigned to promote wound healing by providing cellular and extracellular components with growth factors, cytokines, and collagen and to be a natural barrier to infection.
CLAIMED FEATURES: Composed of living cells, fibroblasts, and keratinocytes and a fully developed extracellular matrix. Does not contain any synthetic or animal materials.
Manufacturer: Soluble Systems, LLC
Information retrieved from manufacturer and/or FDA-approved labels
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ESSENTIALS
Product
Estimated
Out-of-pocket
Cost
HCPCS Class
HCPCS
Theraskin, per square centimeter
Q4121
* 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
$46.05
* 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
Composition: Viable (living) cells
Configuration: Fenestrated/ meshed
Configuration: Sheet
May apply on full-thickness wounds
May apply over exposed tendon/ bone/ muscle
Processing: Cryopreserved
Processing: Minimally manipulated
| 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
For homologous use in diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
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]
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. |
10 units in 12 weeks
|
| CGS Administrators, LLC |
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
|
|
Palmetto
Noridian
Wisconsin Physicians Service Insurance Corporation (WPS)
National Government Services, Inc. (NGS)
|
Carrier discretion |
ASP NDC - HCPCS Crosswalk for Medicare Part B Drugs
Note 1: This crosswalk is based on published drug and biological pricing data and information submitted to CMS by manufacturers. The information is intended to support ASP-based Medicare Part B payments only.
To look up the most recent version of the crosswalk, go to the CMS website
Effective April 1, 2019 through June 30, 2019
HCPCS/ Drug name/ Short description
| National Drug Code (NDC)
| Dosage
| Pkg Size
| Pkg Qty
| Billable units
| Billable units/pkg
|
Q4121/ Theraskin/ Skin and Wound Allograft Institute
| 100TSXS
| 1 SQ CM
| 1 | 1 | 6.25
| 6.25
|
Q4121/ Theraskin/ Skin and Wound Allograft Institute
| 101TSS
| 1 SQ CM
| 12.9
| 1
| 12.9
| 12.9 |
Q4121/ Theraskin/ Skin and Wound Allograft Institute
| 102TSL
| 1 SQ CM
| 38.71
| 1
| 38.71
| 38.71
|
Q4121/ Theraskin/ Skin and Wound Allograft Institute
| 103TSXL
| 1 SQ CM
| 1 | 1 | 115.5
| 115.5 |
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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