Osiris Therapeutics, Inc.

Stravix® 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.

Stravix is a living placental tissue for surgical applications. It serves as an anti-adhesion, anti- inflammatory, and antimicrobial wrap to aid natural wound repair. 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.

• For use in inpatient settings
• Available in two sizes
• 2-year shelf life at -75°C to -85°C
• Minimal preparation required

Durable, conforming, and easy to manipulate
PS60008: Stravix, 3*6 cm
PS60005: Stravix, 2*4 cm

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ESSENTIALS

• HCPCS II
• Features
• Product Reimbursement
• Procedures Reimbursement
• Analysis

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HCPCS Class

HCPCS

Stravix®, Per Square Centimeter

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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

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Features

Stravix®, Per Square Centimeter

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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.

• 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.

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. <