Highmark Medicare Services

12102, 12202, 12302

MAC Part A & B

L27549

Human Skin Equivalents (HSE) - Use in the Treatment of Chronic Cutaneous Ulcer Wounds

L27549

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after N/A

N/A

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Human Skin Equivalents, (HSE), are bioengineered skin products. This Local Coverage Determination (LCD) is limited in the wound treatment products it addresses, to those used in the treatment of chronic cutaneous ulcer wounds; it does not address the treatment of burn wounds or other wounds.

This LCD is further limited to addressing only Food and Drug Administration (FDA) Class III Medical Devices used for wound treatment. It does not address other FDA Class items such as FDA Class II; nor does it address wound management products such as wound dressings.

This LCD is currently applicable to Apligraf^® and Dermagraft^®; however, other products that qualify as FDA Class III Medical Devices, used for the treatment of chronic cutaneous ulcer wounds, may become available. Highmark Medicare Services will consider their use eligible for coverage when used in keeping with the FDA’s approved indications for those products.

Apligraf^® (Graftskin)

Apligraf^® (Graftskin) should be applied to a clean ulcer that has undergone one detailed debridement prior to each application.

The application of Apligraf^® is limited to physicians (M.D., D.O. and D.P.M.'s) who are highly skilled in wound care management and have experience in the use of HSE for the treatment of wounds. The success of the procedure is somewhat dependent on the skill of the performing provider; therefore, the provider may be subject to a post payment peer review in order to verify his/her qualifications.

Patients receiving Apligraf^® must be under the care of a physician for the treatment of their systemic disease process (venous insufficiency and/or diabetes). It is imperative that their systemic disease be monitored/treated, in order to insure adequate healing of the wound site.

Patient Selection Criteria

Apligraf^® is indicated for use in the treatment of venous insufficiency ulcers in conjunction with the recommended post-application compression therapy when all of the following criteria are met and documented:

• The treatment is specific to non-infected partial or full-thickness skin ulcers, at least 1.0 cm² in size, due to clinically documented venous insufficiency (venous insufficiency should be objectively documented either by history of previous deep venous thrombosis in the index leg, or objective documentation of valvular reflux by duplex ultrasound, venography, or air/photo plethysmography);
  
• The ulcer(s) is of at least four (4) weeks in duration;
  
• The medical record supports that the ulcer(s) has been treated by the provider applying the HSE with conventional non-surgical therapy* for a minimum of four (4) weeks and has failed to decrease in size, and the ulcer(s) has not shown any indication (e.g., epithelial in growth and progression towards closure) that improvement is likely; OR the medical record supports that the ulcer is so clinically severe that it requires immediate, aggressive therapy;

* Conventional non-surgical therapy for chronic cutaneous venous insufficiency ulcers may include, but is not limited to, the following: removal of necrotic or infected tissue, off-loading, compression therapy, maintenance of a moist wound environment, management of wound infection, wound cleansing, and nutritional support.

• The patient is competent, and/or has the support services required to participate in follow-up care associated with the treatment of the wound following the application of Apligraf^®.

Apligraf^® is indicated for use in the treatment of neuropathic diabetic foot ulcers when all of the following criteria are met and documented:

• The treatment is specific to non-infected full thickness foot ulcers, at least 1.0 cm² in size, due to clinically documented diabetic neuropathy (type 1 or type 2 diabetes should be objectively documented as well as the current medical management for the diabetes; the neuropathy should be documented also including results of filament testing);
  
• The ulcer is of at least three (3) weeks in duration;
  
• The ulcer is located on the plantar, medial, or lateral surface of the foot and is free of infection, tunnels, and tracts. Additionally, the ulcer must be free of cellulitis, eschar, or obvious necrotic material as this will interfere with the device adherence and wound healing;
  
• The ulcer extends through the dermis but it does not involve the tendon, muscle, capsule or have bone exposure;
  
• The medical record supports that the ulcer(s) has been treated by the provider applying the HSE with conventional non-surgical therapy* for a minimum of three (3) weeks and has failed to decrease in size, and the ulcer(s) has not shown any indication (e.g., epithelial in growth and progression towards closure) that improvement is likely; OR the medical record supports that the ulcer is so clinically severe that it requires immediate, aggressive therapy;

* Conventional non-surgical therapy for chronic cutaneous diabetic foot ulcers may include, but is not limited to, the following: removal of necrotic or infected tissue; off-loading; maintenance of a moist wound environment; management of wound infection; wound cleansing; and nutritional support, including blood glucose control.

• The extremity must be free of active Charcot’s arthropathy;
  
• The patient must have adequate arterial blood supply to support tissue growth;
  
• The patient is competent or has the support system required to participate in the follow-up care associated with treatment of the wound with Apligraf^®.

Prior to Apligraf^® application, it is expected the medical record documentation will contain evidence that the conservative measures have failed, or the medical record supports that the ulcer is so clinically severe that it requires immediate, aggressive therapy. The medical record must reflect that the ulcer has failed to decrease in size and depth, or that there has been no change in baseline size or depth with no sign of improvement, or no indication that improvement is likely.

Additionally, the frequency of the device application for both venous insufficiency ulcers and neuropathic diabetic foot ulcers should be consistent with each patient's specific history and response to the device application. Repeated application without signs of improvement may be denied. Refer to the “Utilization Guidelines” section of this LCD for specific frequency guidelines.

Contraindications

Apligraf^® is contraindicated for use in patients with:

• Clinically infected wounds (i.e., increased exudate, odor, redness, swelling, heat, pain, tenderness to the touch, purulent discharge);
  
• Known allergies to bovine collagen; and
  
• A known hypersensitivity to the components of the agarose shipping medium.

Dermagraft^®

Dermagraft ® should be applied to a clean ulcer that has undergone one detailed debridement prior to each application.

The application of Dermagraft^® is limited to physicians (M.D., D.O. and D.P.M.'s) who are highly skilled in wound care management and have experience in the use of HSE for the treatment of wounds. The success of the procedure is somewhat dependent on the skill of the performing provider; therefore, the provider may be subject to a post payment peer review in order to verify his/her qualifications.

Patients receiving Dermagraft^® must be under the care of a physician for the treatment of their systemic disease processes (diabetes). It is imperative that their systemic disease be monitored/treated, in order to insure adequate healing of the wound site.

Patient Selection Criteria

Dermagraft^® is indicated for use in the treatment of diabetic foot ulcers when all of the following criteria are met and documented:

• The treatment is specific to non-infected full thickness diabetic foot ulcers, at least 1.0 cm² in size, (type 1 or type 2 diabetes should be objectively documented as well as the current medical management for the diabetes; results of filament testing should also be documented);
  
• The ulcer is of at least three (3) weeks in duration;
  
• The ulcer is located on the plantar, medial, or lateral surface of the foot and is free of infection, tunnels, and tracts. Additionally, the ulcer must be free of cellulitis, eschar, or obvious necrotic material as this will interfere with the device adherence and wound healing;
  
• The ulcer extends through the dermis but it does not involve the tendon, muscle, joint capsule or have bone exposure;
  
• The medical record supports that the ulcer(s) has been treated by the provider applying the HSE with conventional non-surgical therapy* for a minimum of three (3) weeks and has failed to decrease in size, and the ulcer(s) has not shown any indication (e.g., epithelial in growth and progression towards closure) that improvement is likely; OR the medical record supports that the ulcer is so clinically severe that it requires immediate, aggressive therapy;

* Conventional non-surgical therapy for chronic cutaneous diabetic foot ulcers may include, but is not limited to, the following: removal of necrotic or infected tissue; off-loading; maintenance of a moist wound environment; management of wound infection; wound cleansing; and nutritional support, including blood glucose control.

• The extremity must be free of active Charcot’s arthropathy;
  
• The patient must have adequate arterial blood supply to support tissue growth;
  
• The patient is competent or has the support system required to participate in follow-up care associated with treatment of the wound with Dermagraft^®.

Prior to Dermagraft^® application, it is expected the medical record documentation will contain evidence that the conservative measures have failed, or the medical record supports that the ulcer is so clinically severe that it requires immediate, aggressive therapy. The medical record must reflect that the ulcer has failed to decrease in size and depth or that there has been no change in baseline size or depth with no sign of improvement or no indication that improvement is likely.

Additionally, the frequency of the device application for diabetic foot ulcers should be consistent with each patient's specific history and response to the device application. Repeated application without signs of improvement may be denied. Refer to the “Utilization Guidelines” section of this LCD for specific frequency guidelines.

Contraindications

Dermagraft^® is contraindicated for use in patients with:

• Clinically infected ulcers (i.e., increased exudate, odor, redness, swelling, heat, pain, tenderness to the touch, purulent discharge) or ulcers with sinus tracts;
  
• Known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.

Apligraf^® and Dermagraft^® are not approved for use with acute surgical wounds, pressure sores and burns. As such, they will be denied for these diagnoses.

Services performed for diagnosis(es)/ICD-9 codes not listed in the “ICD-9 Codes That Support Medical Necessity” section of the policy.

The medical record does not support that all of the guidelines are met in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy.

Application by someone other than an M.D., D.O. or D.P.M.

Surgical Services

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

For the purpose of this policy, re-application is referring to an additional application of skin substitutes to the same ulcer within the same treatment period. Retreatment is referencing a new treatment period where the same ulcer is being treated again because the initial treatment has most likely failed.

Re-applications of all products for all indications should take into consideration each patient's specific history, response to the device application, and product safety criteria. Discontinuation of use should be considered if there are signs or symptoms suggesting wound deterioration such as erythema; pain; discharge; infection; tissue necrosis; requirement for repeated debridements or other surgical interventions; increase in ulcer size; or undesirable alterations of soft tissues, ligaments, periosteum, or joint capsules underlying deep wounds.

All utilization of four or more applications of all products, for all indications, will be suspended and developed for review with a request for medical records.

Accepted Utilization – Apligraf®

A single application of Apligraf® may be all that is required to affect the wound healing in those wounds that are likely to improve by this therapy. The use of additional applications if less than 50% “take” is observed, is limited to a total of four additional applications for the same ulcer.

Additional applications beyond this for one year are generally not considered reasonable and necessary.

Retreatment within one year following the last successful Apligraf® application is generally not considered reasonable and necessary.

Retreatment of an ulcer following the unsuccessful treatment where it consisted of five failed Apligraf® applications is not considered reasonable and necessary.

NOTE: Debridement of the ulcer will not be reimbursed during active treatment with Apligraf®, except for debridement prior to re-applications, or prior to retreatment.

Accepted Utilization – Dermagraft®

A single application of Dermagraft® may be all that is required to affect the wound healing in those wounds that are likely to improve by this therapy. The use of additional applications if less than 50% “take” is observed, is limited to a total of seven additional applications for the same ulcer.

Additional applications beyond this for one year are generally not considered reasonable and necessary.

Retreatment within one year following the last successful Dermagraft® application is generally not considered reasonable and necessary.

Retreatment of an ulcer following the unsuccessful treatment where it consisted of eight failed Dermagraft® applications is not considered reasonable and necessary.

NOTE: Debridement of the ulcer will not be reimbursed during active treatment with Dermagraft®, except for debridement prior to re-applications, or prior to retreatment.

B. Cairns, MD, S. Peterson, DDS, MD, A. Meyer, MD, PhD; Skin Replacements, Arch Surg/VOL 128, November 1993

Bello YM, Falabella AF, Eaglstein WH; Tissue-engineered skin. Current status in wound healing, Am J Clin Dermatol 2001;2(5):305-13

David P. Fivenson MD, Lubomira Scherschun MD, Michelle Choucair MD, Debra KuKuruga PhD, Janet Young PhD, Tor Shwayder MD, Graftskin therapy in epidermolysis bullosa; Journal of the American Academy of Dermatology Volume 48 • Number 6 • June 2003

Edmonds M, Bates M, Doxford M, Gough A, Foster A.; New treatments in ulcer healing and wound infection., Diabetes Metab Res Rev 2000 Sep-Oct;16 Suppl 1:S51-4

Eliot N. Mostow, MD, MPH, Wound healing:  A multidisciplinary approach for dermatologists; Dermatologic Clinics Volume 21 • Number 2 • April 2003

Gerald T. Lionelli, MD, W. Thomas Lawrence, MPH, MD, Wound dressings; Surgical Clinics of North America Volume 83 • Number 3 • June 2003

Harold Brem, MD, Robert S. Kirsner, MD, Vincent Falanga, MD, Protocol for the successful treatment of venous ulcers, American Journal of Surgery Volume 188 • Number 1 Suppl 1 • July 1, 2004

Harold Brem, M.D, Peter Sheehan, M.D., Andrew J.M. Boulton, M.D., Protocol for treatment of diabetic foot ulcers; American Journal of Surgery Volume 187 • Number 5 Suppl 1 • May 1, 2004

Pablo A. Jimenez, M.D., Sydney E. Jimenez, M.D, Tissue and cellular approaches to wound repair; American Journal of Surgery Volume 187 • Number 5 Suppl 1 • May 1, 2004

R. Kirsner, MD, V. Falanga, MD, D. Fivenson, MD, K. Thibodeaux, MD, J. Cavorsi, MD, D. De La Pava, MD, H. Brem, MD, C. Golamb, MD; Clinical Experience with a Human Skin Equivalent for the Treatment of Venous Leg Ulcers: Process and Outcomes, November/December 1999, Wounds

Sylvan Wallenstein, PhD, Harold Brem, MD, Statistical analysis of wound-healing rates for pressure ulcers; American Journal of Surgery Volume 188 • Number 1 Suppl 1 • July 1, 2004

Susan Alpert, Office of Device Evaluation, FDA, Premarket Approval Letter, May 22, 1998

V. Falanga, MD, FACP; How to Use Apligraf^® to Treat Venous Ulcers, Skin & Aging, February 1999

V. Falanga, MD, D. Margolis, MD, O. Alvarez, PhD, M.Auletta, MD, F. Maggiacomo, DO, M. Altman, DPM, J. Jensen, DPM, M. Sabolinski, MD, J. Hardin-Young, PhD: Rapid Healing of Venous Ulcers and Lack of Clinical Rejection With an Allogenic Cultured Human Skin Equivalent, Arch Dermatol/Vol 134, March 1998

V. Falanga, MD, FACP, M. Sabolinski, MD; A Bilayered Living Skin Construct (APLIGRAF^®) Accelerates Complete Closure Of Hard-To-Heal Venous Ulcers, Wound Repair and Regeneration, July-August 1999

W. Eaglstein, MD, V. Falanga, MD; Tissue Engineering and the Development of Apligraf, a Human Skin Equivalent, Clinical Therapeutics, Vol,19, NO. 5, 1997

Wei Li, PhD, Bahar Dasgeb, MD, Tania Phillips, MD, Yong Li, MD, Mei Chen, PhD, Warren Garner, MD, David T. Woodley, MD, Wound-Healing Perspectives; Dermatologic Clinics Volume 23 • Number 2 • April 2005

Medicare’s National Level II Codes HCPCS 2000, American Medical Association

Margolis DJ, Kantor J, Berlin JA. Healing of Diabetic Neuropathic Foot Ulcers Receiving Standard Treatment. Diabetes Care 22: 692-695, 1999.

Zimny S, Schatz H, Pfohl M. Determinants and estimation of healing times in diabetic foot ulcers. J Diabetes and Its Complications 16: 327-332, 2002.

Curran MP, Plosker GL. Bilayered Bioengineered Skin Substitute (Apligraf®) A Review of its Use in the Treatment of Venous Leg Ulcers and Diabetic Foot Ulcers.  BioDrugs 16(6): 439-455, 2002.

Veves A, Falanga V, Armstrong DG, Sabolinski ML.  Graftskin, a Human Skin Equivalent, is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers. Diabetes Care 24(2): 290-295, 2001.

Brem H, Balledux J, Bloom T, Kerstein MD, Hollier L. Healing of Diabetic Foot Ulcers and Pressure Ulcers with Human Skin Equivalent. Arch Surg 135: 627-634, 2000.

Brem H, Balledux J, Sukkarieh T, Carson P, Falanga V.  Healing of Venous Ulcers of Long Duration with a Bilayered Living Skin Substitute: Results from a General Surgery and Dermatology Department. Dermatol Surg 27: 915-919, 2001.

Brem H, Young J, Tomic-Canic M, Isaacs C, Ehrlich HP.  Clinical efficacy and mechanism of Bilayered Living Human Skin Equivalent (HSE) in Treatment of Diabetic Foot Ulcers.   Surgical Technology international XI: 23-31, 2003.

Marston WA, Hanft J, Norwood P, Pollak R.  The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers. Diabetes Care 26(6): 1701-1705, 2003.

Gentzkow GD, Iwasaki SD, Hershon KS, Mengel M, Prendergast JJ, Ricotta JJ, Steed DP, Lipkin S. Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers. Diabetes Care 19(4): 350-354, 1996.

Hanft J, Surprenant MS. Healing of Chronic Foot Ulcers in Diabetic Patients Treated with a Human Fibroblast-Derived Dermis. J Foot & Ankle Surgery 41(5): 291-299, 2002. 

US Dept. of Health and Human Services Food and Drug Administration (CDER, CBER, CDRH). Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds – Developing Products for Treatment. June 2006.

Other Contractors' Policies

Highmark Medicare Services Contractor Medical Directors

This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

CAC/IAC Distribution:  04/01/2008

05/15/2008

05/23/2008

L27549

05/22/2008

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