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FlōGraft® Amniotic Fluid-Derived Allograft

Applied Biologics™

FlōGraft® is chorion-free allograft comprised of amnion and amniotic fluid derived from prescreened, live, healthy donors. Amniotic membrane and fluid act as a biologic system that ensures symmetrical structure development and growth; cushions and protects the embryo; has a significant defensive role as a part of the innate immune system, and protects the fetus by maintaining consistent pressure and temperature. FlōGraft® retains this protective function as a versatile and manageable liquid allograft and is indicated as an additive in a number of general surgical applications including soft tissue defects, soft tissue trauma, tendinitis, tendinosis, chronic wounds, and localized inflammation.

FlōGraft® is a cryopreserved, injectable amniotic fluid-derived allograft that is used to protect and promote development of the injured site. These human cells, tissues, and cellular and tissue-based products (HCT/Ps) are minimally manipulated amniotic fluid products and intended for homologous use only.

Amniotic fluid contains nutrients and growth factors that facilitate fetal growth and provides mechanical cushioning and antimicrobial properties that protect the fetus. Amniotic fluid also contains carbohydrates, proteins and peptides, lipids, lactate, pyruvate, electrolytes, enzymes, hormones, epidermal growth factor, amnion-derived stem cell, transforming growth factor (TGF)-a, TGF-b1, and fibroblast growth factor (FGF), hyaluronic acid, amnion epithelial cells, derived from the embryonic ectoderm, and amnion mesenchymal cells. It should be noted that the presence of the referenced native organic components may provide an ancillary benefit to FloGraft’s primary purpose as a soft tissue defect filler.

FlōGraft: 0.25cc: Q4139
FlōGraft: 0.50cc: Q4139
FlōGraft: 1.00cc: Q4139
FlōGraft: 2.00cc: Q4139
FlōGraft: 4.00cc: Q4139
FlōGraft: 6.00cc: Q4139

* 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

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Rating
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HCPCS Class
HCPCS
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Choose the state for Medicare
DME coverage and co-payment
Manufacturer
Product
Rating
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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
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Product
Rating
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Recom / Evidence
FDA Safety
Quality Measures
Cost Effectiveness
Product
Rating
Suppliers Price
Features
FlōGraft® Amniotic Fluid-Derived Allograft
Composition: Human placenta or umbilical cord Composition: Viable (living) cells Configuration: Flowable May apply on full-thickness wounds May apply over exposed tendon/ bone/ muscle Processing: Cryopreserved Processing: Minimally manipulated Storage: refrigeration needed
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 $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) $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 $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 $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 $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.

CLINICAL

Indications 

  • Soft tissue defect filler
  • Soft tissue trauma
  • Tendinitis
  • Tendinosis
  • Chronic wounds
  • Localized inflammation
  • Joint pain
  • Strains, partial tears (muscles, ligaments, tendons)

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] Amniotic fluid, in utero, naturally functions to protect, cushion and lubricate.



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