Stravix®

First published on 11/16/17 | Last updated on 3/31/19 | Literature review current through Aug. 2019 [cite]

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Technology and Product Assessment

Product Type: Allogeneic matrix

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.

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: Osiris Therapeutics, Inc.

Information retrieved from manufacturer and/or FDA-approved labels

* Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients. The product information contained on this page, including the product images and additional product materials, was collected from various supplier sources. All product claims and specifications are those of the product suppliers. Every effort has been made to ensure the accuracy of the product information, however on occasion manufacturers may alter their products or packaging without notice. Wound Reference assumes no liability for inaccuracies or misstatements about products. The properties of a product may change or be inaccurate following the posting or printing of the product information in the document, either in the print or online version. Due to product changes, information listed in this document is subject to change without notice. We recommend that you always read labels, warnings and instructions for use before using a product. Content on this site is for reference purposes and is not intended to be a substitute for professional advice given by a physician or other licensed healthcare professional.

ESSENTIALS

Product

Estimated
Out-of-pocket
Cost

HCPCS Class

HCPCS

Stravix®, Per Square Centimeter

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Choose the 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

Osiris Therapeutics, Inc.
Stravix®, Per Square Centimeter

$.00

Coming soon

* 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.

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Product

Estimated
Out-of-pocket
Cost

Recom / Evidence

FDA Safety

Quality Measures

Cost Effectiveness

Stravix®, Per Square Centimeter

Coming soon

Product

Estimated
Out-of-pocket
Cost

Features

Stravix®, Per Square Centimeter

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
C5271	Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
C5273	Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
C5274	Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure)
C5275	Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
C5272	Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure)
C5276	Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure)
C5277	Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
C5278	Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately with primary procedure)

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.

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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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Download WoundReference Algorithm on "How to Select Cellular and/or Tissue Products"

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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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

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Stravix®

Stravix®

ESSENTIALS

Download WoundReference Algorithm on "How to Select Cellular and/or Tissue Products"

CLINICAL

Overview

How supplied:

Indications

FDA

CODING, COVERAGE, REIMBURSEMENT

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