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Apligraf®

Apligraf®

Organogenesis

Apligraf is a living, cell-based, bilayered skin substitute designed to treat chronic venous leg ulcers and diabetic foot ulcers. The lower layer contains bovine type 1 collagen and human fibroblasts to form a dermis-like structure that produces additional matrix proteins. Human keratinocytes form an epidermal layer to replicate the structure of the human epidermis. The human keratinocytes and fibroblasts are derived from neonatal foreskins. Apligraf is believed to stimulate the patient's own cells to regenerate tissue and heal the wound through mechanisms that may include the secretion of growth factors, cytokines, and matrix proteins. Apligraf does not contain melanocytes, Langerhans' cells, macrophages, lymphocytes, or tissue structures such as blood vessels, hair follicles, and sweat glands. 

* 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
Rating
Suppliers Price
HCPCS Class
HCPCS
* Hover on the information button next to each header for detailed explanation on the type of information provided by the table
Choose the state for Medicare
DME coverage and co-payment
Manufacturer
Product
Rating
Suppliers Price
Patient DME Co-Payment per Billable Unit
DME Reimbursement to Suppliers
Frequency Replacement if Requirements Met
Office and/or Facility - Product reimbursement
Apligraf®, Skin Substitute Per Square Centimeter
$.00
per square centimeter (non-DMEPOS)
See Coding, Coverage and Reimbursement
$30.89
* 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
Rating
Suppliers Price
Recom / Evidence
FDA Safety
Quality Measures
Cost Effectiveness
Product
Rating
Suppliers Price
Features
Apligraf®, Skin Substitute Per Square Centimeter
Composition: Animal-derived Composition: Human dermis with/without epidermis Configuration: Sheet May apply on full-thickness wounds Processing: Fresh (limited shelf life)
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

  • For use with standard therapeutic compression for the treatment of noninfected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
  • Apligraf is also indicated for use with conventional diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which extend through the dermis but without tendon, muscle, capsule or bone exposure.

FDA

In December 1998, FDA approved Apligraf for marketing under the PMA process. Apligraf is included in FDA product code MGR (dressing, wound and burn, interactive).

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. 

Frequency of replacement allowed by Medicare:



Medicare Administrative Contractor (MAC) Frequency of replacement if requirements met
Novitas Solutions, Inc. 10 units in 12 weeks
CGS Administrators, LLC 10 units in 12 weeks
Palmetto 10 units in 12 weeks
First Coast Service Options, Inc. (FCSO)

1 type of product per 12 weeks, fewest repeat applications and

amount of product is expected

Noridian

Wisconsin Physicians Service Insurance Corporation (WPS)

National Government Services, Inc. (NGS)

Carrier discretion

More details on requirements, medical necessity and documentation in specific Medicare Local Coverage Determinations (if available). See section on Coding, Coverage and Reimbursement in topic "Cellular and/or Tissue Products". 

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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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