Contractor Name 

National Government Services, Inc.

Contractor Number 

Contractor Type 

Carrier 

FI

MAC-Part A

MAC-Part B

Article ID Number 

A46090

Article Type 

Article

Key Article 

Yes

Article Title 

Dermagraft ® – 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:

Dermagraft ® (DT) is a single layered skin product derived from cryopreserved human fibroblast. DT is also manufactured from a living newborn male foreskin and is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. It is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure.

A partial thickness skin ulcer is one in which the wound base is visible and the ulcer does not extend through the dermis. A full thickness skin ulcer is one in which the wound base is visible and the ulcer extends through the dermis but not into the subcutaneous tissue to fascia, muscle or bone.

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.

This article sets forth the criteria for coverage and instructions for claim submission for Dermagraft ®. The brand named product, Dermagraft ®, is an example of a tissue substitute. This article will also apply to any Food and Drug Administration (FDA) approved skin substitute product meeting the criteria of this article.

Indications

Use of Dermagraft ® will be considered reasonable and necessary when the following conditions are satisfied and documented.

When used with standard diabetic foot ulcer care for neuropathic Diabetic Foot Ulcers (DFU):

• Only if patient has a current medical diagnosis of Type I or Type II of diabetes mellitus;
• Only if the patient does not have a current HbA1C reading exceeding 12%;
• Only for full thickness ulcers that have been in existence for greater than six weeks;
• Only for ulcers which have failed to respond to documented conservative treatment measures of greater than six weeks;
• Only for ulcers located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, sinus tracts or tunnels, eschar or any necrotic material that could interfere with the adherence of Dermagraft ®, and process of wound healing;
• Only for ulcers which extend through the dermis but without tendon, muscle, capsule or bone exposure;
• 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.

Dermagraft ® treatment must be used in conjunction with following standard conservative measures:

• Use of pressure-reducing footwear;
• A non-weight bearing regimen;
• Debridement of necrotic and callused tissue when necessary; and
• Acceptable methods of wound care, such as saline moistened dressings;
• 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 Dermagraft ®.

Limitations

• The use of Dermagraft ® 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.

• Dermagraft ® is contraindicated for use in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.
• Dermagraft ® should not be used on wounds that have signs of clinical infections.
• Retreatment of the same ulcer using Dermagraft ® within one year following the last successful or unsuccessful treatment is not recommended, and will not be reimbursed.
• Since application of Dermagraft ® as well as any subsequently-accepted similar product is considered a physician service, it must be applied by either a physician or a non-physician provider (NPP), and not by a non-advance practice nurses, therapists or medical assistants.

Primary ICD-9 Codes

Secondary ICD-9 Codes

Utilization Guidelines

• Retreatment with Dermagraft ® on the same ulcer within one year following the last successful or unsuccessful treatment is not recommended, and will not be reimbursed.
• Medicare does not cover continued reapplication of Dermagraft ® when the treatment is unsuccessful after two applications.
• Medicare does not cover continued reapplication of Dermagraft ® for the same ulcer if satisfactory and reasonable healing progress is not noted after 12 weeks of therapy.
• Medicare does not cover retreatment of the same ulcer using Dermagraft ® following an unsuccessful course of treatment.
• 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 Dermagraft ®, (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 Dermagraft ®: 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).

Claims for the use of Dermagraft ® must contain both a primary and secondary diagnosis as listed below.

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 Services
 

CPT/HCPCS Codes 

Other Comments 

Sources of Information and Basis for Decision

• FDA Product Label, September 26, 2001, http://www.fda.gov/cdrh/pdf/P000036c.pdf.
• Dermagraft ®, Prescribing Information, La Jolla, CA: Marketed by: Advanced BioHealing, Inc., 2007.
  
  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 - CPT/HCPCS code J7342 was deleted from group 1

Revision History Explanation 

R4(effective 01/01/2009) 2009 HCPCS Annual Update - CPT/HCPCS Code J7342 deleted. CPT/HCPCS Code Q4106 added. Removal of the following bullet from the "Utilization Guidelines": Use of Dermagraft ® substitute on diabetic ulcers may require up to eight weekly applications over a course of twelve (12) weeks. Therefore, CPT codes 15360 and 15361 refer to a course of therapy and may be between 1 - 8 applications within 90 days. Therefore, the use of the following modifiers is not appropriate: -58 (Staged procedure), -76 (Repeat procedure by the same physician), -78 (Return to the operating room for a related procedure during the postoperative period), and/or -79 (Unrelated procedure or service by the same physician during the postoperative period). Medicare payment for Dermagraft ® is limited to eight applications per ulcer. 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. Payable places of service for the application of Dermagraft ®: 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) 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 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 Article published February 2008
ICD-9 code 707.15 added to match the narrative that states the coverage includes the toes.

This article has an effective date of 12/01/2007.

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 - CPT/HCPCS code J7342 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