Contractor Name 

National Government Services, Inc.

Contractor Number 

Contractor Type 

Carrier

FI

MAC-Part A

MAC-Part B

Article ID Number 

A46092

Article Type 

Article

Key Article 

Yes

Article Title 

Apligraf ® – Related to LCD L26003

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2008 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.

Primary Geographic Jurisdiction 

Original Article Effective Date 

12/01/2007

Article Revision Effective Date 

01/01/2009

Article Text 

Abstract:

Dermal-epidermal tissue (DET) substitute (e.g., Apligraf ®) is a bi-layered skin product approved for use in the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency, i.e., venous stasis ulcers (VSUs), and full thickness neuropathic diabetic foot ulcers (DFUs). Apligraf ® is manufactured from a living neonatal male foreskin and it consists of two primary layers: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice.

For the purpose of this article, 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.

Indications

Apligraf ® will be considered reasonable and necessary when the following conditions are satisfied and documented:
When used with standard therapeutic compression for VSUs:

1. Only for ulcers that have failed to respond to documented conservative measures of greater than six (6) weeks in duration, that have at minimum included regular dressing changes, debridement of necrotic tissue and standard therapeutic compression. A "failed response" is defined as an ulcer that has increased in size or depth, or for which there has been no change in baseline size or depth and no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress towards closing. Documentation of response, or lack thereof, requires measurement of the ulcer at baseline, following cessation of conservative or conventional management. Documentation should also include measurement of the ulcer immediately prior to the placement of Apligraf ®.
2. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g. hypertension, is provided and documented in conjunction with the treatment; and
3. Only for ulcers that are free of infection, redness, drainage, underlying osteomyelitis, surround cellulitis, sinus tracts or tunnels, eschar or any necrotic material that could interfere with the adherence of Apligraf ® and wound healing.

When used with standard diabetic foot ulcer care for neuropathic DFUs:

1. Only if the patient has the current medical diagnosis of either Type I or Type II diabetes mellitus;
2. Only if the patient does not have a current HbA1C reading exceeding 12%;
3. Only for full thickness ulcers of greater than three weeks in duration, which extend through the dermis but without tendon, muscle, capsule or bone exposure;
4. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g., diabetes is provided and documented in conjunction with treatment; and
5. Only for ulcers located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material that could interfere with the adherence of Apligraf ®, and the process of wound healing.

For both VSUs and DFUs all of the following must also be satisfied and documented:

1. The patient must have adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in limb undergoing the procedure;
2. DET treatment must be used in conjunction with following standard conservative measures:
• Use of pressure-reducing footwear;
• A non-weight bearing regiment;
• Debridement of necrotic and callused tissue when necessary; and
• Acceptable methods of wound care, such as saline moistened dressings
3. The patient must be competent and/or have the support system required to participate in follow-up care associated with treatment of the wound with Apligraf ®.

Limitations

The use of Apligraf ® on ulcers with any of the following conditions is considered not necessary and reasonable, and will result in denial of a claim:

• cellulitis;
• osteomyelitis;
• necrotic ulcer;
• draining wound;
• bone exposed- wound bed; or
• clinically significant wound healing impairment due to uncontrolled diabetes.

Apligraf ® is contraindicated for use in patients with known allergy or hypersensitivity to bovine collagen, or to the components of the Apligraf ® agarose shipping medium, (agarose, L-glutamine, hydrocortisone/bovine serum albumin, bovine insulin, human transferrin, triiodothyronine, ethanolamine, O-phosphorylethanolamine, adenine, selenious acid, DMEM powder, HAM's F-12 powder, sodium bicarbonate, calcium chloride, and water for injection. In vitro and in vivo histology studies have shown that Apligraf ® either degrades or its cell viability is reduced when the device is exposed to the following cytotoxic agents: Dakin's solution, Mafenide acetate, Scarlet red dressing, Tincoban, Zinc sulfate, Povidone-iodine solution, Chlorhexidine, or Polymixin/Nystatin. The use of Apligraf ® with these solutions will be considered not reasonable and necessary, and will result in denial of reimbursement.

The scope of the practice for Podiatry is defined by state law and the individual state laws should be consulted in determining a specific podiatrist’s (or doctor of podiatric medicine) scope of practice.

ICD-9-CM Codes that are Covered

*Must be billed with a Diabetes ICD-9-CM code listed as the primary diagnosis.

Utilization Guidelines

• A single application of DET for any particular ulcer is usually all that is required to affect wound healing in those wounds that are likely to be helped by this therapy. Treatment with Apligraf ® is usually expected to last no more than twelve (12) weeks and to involve a maximum of four Apligraf ® applications for any ulcer that initially qualifies for treatment. The use of more than four applications for the same ulcer is not considered reasonable and necessary and will not be reimbursed.
• Re-application of Apligraf ® within three weeks for the same ulcer is not considered reasonable and necessary and will not be reimbursed.
• Re-application of Apligraf ® where initial application has resulted in no decrease in size or depth or increase in granulation tissue, epithelialization, or progress towards closing, will be denied as not reasonable and necessary and will not be reimbursed.
• Re-treatment within one year following the last successful application with DET is not considered reasonable and necessary, and will not be reimbursed.
• Retreatment of an ulcer following the unsuccessful treatment where it consisted of two failed Apligraf ® applications is not considered reasonable and necessary, and will not be reimbursed.
• These codes are not intended to be reported for simple graft application alone or application stabilized with dressings (eg, by simple gauze wrap). The skin substitute/graft is anchored using the surgeon's choice of fixation. (CPT 2007). If it is not medically reasonable and necessary to anchor the Apligraf ®, (for example, due to size, depth or location of the wound), then the application is included in the appropriate E&M code and should not be submitted with the application codes.

Coding Guidelines
Payable places of service for the application of Apligraf : office (11), inpatient hospital (21), outpatient hospital (22), hospital emergency room (23), ambulatory surgical center (24), Skilled Nursing Facility (31), Nursing Facility (32) and independent clinic (49).

ICD-9-CM codes 707.12, 707.13, 707.14 and 707.15 must be billed with a Diabetes ICD-9-CM code listed as the primary diagnosis.

Coverage Topic 

Surgical Dressings 

CPT/HCPCS Codes 

Other Comments 

Sources of Information and Basis for Decision

• Brem H, et al., Healing of Venous Ulcers of Long Duration With a Bilayered Living Skin Substitute: Results from a General Surgery and Dermatology Department, Dermatol Surg, 2001;27:915-919.
• Falanga V, Sabolinski M., A Bilayered Living Skin Construct (APLIGRAF) Accelerates Complete Closure of Hard-to-Heal Venous Ulcers, Wound Rep Reg., 1997;7:201-207.
• Witten, Celia M., Ph.D., M.D., Department of Health and Human Services, Food and Drug Administration, Premarket Approval (PMA), June 20, 2000, http://www.fda.gov/cdrh/pdf/P950032S016c.pdf
• Curran, Monique P.; Plosker, Greg L., 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.
  
  08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this LCD as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.
  
  11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.
  
  11/09/2008 - The description for CPT/HCPCS code 15341 was changed in group 1
  
  11/09/2008 - CPT/HCPCS code J7340 was deleted from group 1

Revision History Explanation 

R4 (effective January 1, 2009)
2009 HCPCS Annual Update - CPT/HCPCS Code J7340 deleted. CPT/HCPCS Code Q4101 added. CPT/HCPCS Code 15341 descriptor changed to “EACH ADDITIONAL 25 SQ CM, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)”. Corrected "ICD-9-CM Codes that are covered". Removed ICD-9-CM codes 249.00, 249.01, 249.10, 249.11, 249.20, 249.21, 249.30, 249.31, 249.40, 249.41, 249.50, 249.51, 249.90, 249.91. Added ICD-9-CM codes 250.60, 250.61, 250.62, 250.63, 250.70, 250.71, 250.72, 250.73, 250.82, 250.83. Added to Coding Guidelines - ICD-9-CM codes 707.12, 707.13, 707.14 and 707.15 must be billed with a Diabetes ICD-9-CM code listed as the primary diagnosis. No additional comment or notice periods required and none given.

R3 (effective October 1, 2008):
Change Request: 6107
Medicare Contractor Annual Update of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)
Effective Date: 10/01/2008
Addition of ICD-9-CM codes 249.00, 249.01, 249.10, 249.11, 249.20, 249.21, 249.30, 249.31, 249.40, 249.41, 249.50, 249.51, 249.60, 249.61, 249.70, 249.71, 249.80, 249.81, 249.90 and 249.91.

R2 (effective date 07/18/2008) This Article was revised to add the Jurisdiction 13 (J-13) MAC contractor numbers.

This revised Article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the Article is effective on August 1, 2008; for Upstate New York – Part B, the Article is effective on September 1, 2008; and for New York and Connecticut – Part A, the Article is effective on November 14, 2008. For New York – Part A (contract 00308), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

R1 (effective 03/01/2008):
Revised the second bullet in the Utilization Guidelines section to indicate that re-application of Apligraf ® within three weeks for the same ulcer is not considered medically necessary.
Added ICD-9-CM code 707.15 as a covered diagnosis code (when used with one of the secondary diagnosis codes listed).
Added a coding guidelines for payable places of service.

The original version of the corresponding LCD became effective on 12/01/2007.

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.

11/09/2008 - The description for CPT/HCPCS code 15341 was changed in group 1

11/09/2008 - CPT/HCPCS code J7340 was deleted from group 1

Related Documents 

Article(s)
A45056 - Biologic Products for Wound Treatment and Surgical Interventions - Supplemental Instructions Article

LCD(s)
L26003 - Biologic Products for Wound Treatment and Surgical Interventions