Last updated on 8/28/23 | First published on 12/30/20 | Literature review current through Mar. 2024
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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
Information retrieved from manufacturer and/or FDA-approved labels
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ESSENTIALS
Product
Estimated
Out-of-pocket
Cost
HCPCS Class
HCPCS
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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
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Product
Estimated
Out-of-pocket
Cost
Recom / Evidence
FDA Safety
Quality Measures
Cost Effectiveness
Product
Estimated
Out-of-pocket
Cost
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 Code | Description |
Physician Reimbursement - Office
|
Physician Reimbursement - Facility
|
Facility Reimbursement
|
| G0460 | Autolog prp not diab ulcer |
$0.00
|
$0.00
|
$1,749.26
|
| G0465 | Autolog prp diab wound ulcer |
$0.00
|
$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.
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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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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]:
- Blood withdrawal kit
- Coagulation initiator and accelerator component
- 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.
Actigraft is eligible for reimbursement nationally from Medicare and Medicare Advantage via NCD 270.3 and G-0465 & G-0460 CTP codes.[4]
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