Last updated on 1/26/21 | First published on 11/16/17 | 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.
Stravix® is a cryopreserved placental tissue, composed of the umbilical amnion and Wharton’s Jelly (allogeneic matrix).
INTENDED USES: It serves as an anti-adhesion, anti- inflammatory, and antimicrobial wrap to aid natural wound repair. For use in inpatient settings.
CLAIMED FEATURES: Cryopreserved placental tissue, composed of the umbilical amnion and Wharton’s Jelly, retains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue. It is a living placental tissue for surgical applications. As a viable wrap for surgical procedures, Stravix conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly. Stravix is manufactured using a proprietary process allowing the tissue to retain its native components. 2-year shelf life at -75°C to -85°C. Minimal preparation required Durable, conforming, and easy to manipulate,
OPTIONS: Per square centimeter. Sizes - 3*6 cm Stravix, 2*4 cm
Manufacturer: Smith and Nephew (Osiris Therapeutics, Inc.)
Information retrieved from manufacturer and/or FDA-approved labels
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ESSENTIALS
Product
Estimated
Out-of-pocket
Cost
HCPCS Class
HCPCS
Grafix prime, grafixpl prime, stravix and stravixpl, per square centimeter
Q4133
* 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
$131.04
* 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
Composition: Viable (living) cells
May apply on full-thickness wounds
May apply over exposed tendon/ bone/ muscle
Processing: Cryopreserved
Processing: Minimally manipulated
Shelf life: Greater than 2 years
Storage: refrigeration needed
| 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
|
|
| 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
Overview
Stravix® is a cryopreserved human placental tissue composed of umbilical amnion and Wharton’s jelly. According to the manufacturer Osiris Therapeutics, Stravix retains the native collagen and hyaluronic acid-rich extracellular matrix (ECM), endogenous growth factors, and endogenous cells including epithelial cells, fibroblasts, and mesenchymal stem cells (MSCs) found in placental tissue.
- Available in two sizes
- 2-year shelf life at -75°C to -85°C
- Minimal preparation required
- Durable, conforming, and easy to manipulate
- Defined as an HCT/P under Section 361 of the Public Health Service Act and 21 CFR Part 1271
How supplied:
- PS60008: Stravix, 3*6 cm
- PS60005: Stravix, 2*4 cm
Indications
Stravix can be used as a surgical covering or wrap for several procedures, including but not limited to:
- Tendon Repair
- Achilles Tendon Rupture
- Bunionectomy
- Hallux Rigidus Correction
- Foot Amputations
- Fibromatosis
- Arthrodesis
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.
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CODING, COVERAGE, REIMBURSEMENT
In the U.S., Stravix does not have a Q code and is reimbursed through the diagnosis-related group (DRG) system.
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Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.Dermagraft should be used in conjunction with standard wound care regimens and in patients that have ad
