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ActiGraft

ActiGraft

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Technology and Product Assessment
Product Type: Other Cellular and/or Tissue Based Products (CTPs)
Other related products
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.

ActiGraft® is an autologous blood clot product 

CLAIMED FEATURES: ActiGraft® is an FDA-cleared regenerative wound care solution that enables health care providers to produce—in real time—in vitro blood clots from a patient’s whole blood. Once applied, the blood clot tissue serves as a protective covering, biologic scaffold and wound microenvironment to promote the natural wound healing processes of the body.

INTENDED USE: ActiGraft is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.

Clot size: 6sq cm



Manufacturer: RedDress
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
ActiGraft®
Skin substitute, not otherwise specified
Q4100
* 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
ActiGraft®
RedDress
ActiGraft®
$.00
(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
ActiGraft®
Coming soon
Coming soon
Product
Estimated
Out-of-pocket
Cost
Features
ActiGraft®
Composition: Viable (living) cells May apply on full-thickness wounds May apply over exposed tendon/ bone/ muscle May apply over infected tissue Processing: Fresh (limited shelf life) Processing: Minimally manipulated
CPT CodeDescription Physician Reimbursement - Office Physician Reimbursement - Facility Facility Reimbursement
15271Application of 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. * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $145.08 $87.48 $1,568.43
15272Application of 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) * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $28.08 $18.36 $0.00
15273Application of 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. * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $309.24 $211.68 $2,710.48
15274Application of 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) $73.08 $47.88 $0.00
15275Application of 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. * Facility reimbursement: for high cost skin substitutes, refer to column "facility reimbursement" of this CPT code. For low cost, refer to CPT codes C5271 to C5278 $153.36 $99.00 $1,568.43
15276Application of 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) $35.64 $26.28 $0.00
15277Application of 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.* Facility reimbursement: For low cost skin substitute, refer to CPT codes C5271 to C5278 $338.40 $238.68 $1,568.43
15278Application of 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 in addition to code for primary procedure) $87.48 $60.12 $0.00
  • 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

Specifications

ActiGraft (formerly RD1 System) contains 3 sets of components for drawing and handling autologous blood and allowing it to clot in a controlled manner in order to form the provisional wound matrix (preparation kit) [1]:

  1. Blood withdrawal kit
  2. Coagulation initiator and accelerator component
  3. Clotting trays

All ActiGraft kit components are single-use.

Mechanism of action

This autologous blood clot tissue appears to meet the requirements as a living cell biologic. Although the central component of this therapy is blood, the autologous clot tissue creates a scaffold that performs  as a biologic delivery system that functions to control the release of growth factors and cytokines over several days. The matrix contains viable cells that are autologous, biocompatible, biological and consistent with a metabolically  active scaffold. It is proposed that this stroma may replace the extracellular matrix and facilitate the movement of cells such as keratinocytes, fibroblasts and endothelial cells among others.[2][3]

Indications

  • ActiGraft is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the whole blood clot gel produced by the ActiGraft System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.[1] 

Contraindications

  • The ActiGraft System is contraindicated in patients with wounds due to malignancy or wounds with active clinically diagnosed infection.

FDA

In 2018, ActiGraft received U.S. Food and Drug Administration (FDA) 510(k) clearance, under 21CFR 864.9245 (Automated blood cell separator).[1]

Evidence and Recommendations

Please refer to section 'Cellular and/or Tissue Products' in topic "Diabetic Foot Ulcers - Treatment" for other recommendations, rationales and summary of evidence supporting the recommendation below:

  • 2COther CTPs: For more superficial, non-infected, nonischemic DFUs (Texas 1A or 2A) that failed 4 weeks of standard therapy, clinicians might consider autologous blood clot product in addition to standard care, if other CTPs are not available (Grade 2C).
  • The FDA determined that ActiGraft is substantially equivalent to the predicate 3C Patch System. The ActiGraft System has the same intended use and very similar indications for use, technological characteristics, and principles of operation as its predicate device.[1] 

Instructions for use 

  • To use the kit, 10ml of blood is drawn into a sterile syringe containing CPDA1 anticoagulant. The citrated blood is then gently mixed with a suspension of calcium gluconate and kaolin powder, and the coagulating blood is placed in a sterile clotting tray, containing cotton gauze, to coagulate for 12 minutes. After 12 minutes, the whole blood clot is placed on a wound and dressed with a secondary sterile non-adherent dressing.
  • All kit elements and reagents are disposed of after a single use of the kit. The procedure may be repeated with a new kit after a few days.

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:

  • CY 2020: low cost




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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.

REFERENCES

  1. FDA. 510(K) SUMMARY RedDress Ltd.’s RD1 System . 2018;.
  2. Snyder RJ, Schultz G, Wachuku C, Rashid AM, Ead JKK et al. Proposed Mechanism of Action of Topically Applied Autologous Blood Clot Tissue: A Quintessential Cellular and Tissue Based Therapy. Journal of the American Podiatric Medical Association. 2020;.
  3. Snyder RJ, Kasper MA, Patel K, Carter MJ, Kushnir I, Kushnir A, Serena TE et al. Safety and Efficacy of an Autologous Blood Clot Product in the Management of Texas 1A or 2A Neuropathic Diabetic Foot Ulcers: A Prospective, Multicenter, Open Label Pilot Study. Wounds : a compendium of clinical research and practice. 2018;volume 30(7):84-89.
Topic 1579 Version 1.0