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Article
ID Number
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A46090
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Article
Type
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Article
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Key
Article
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Yes
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Article
Title
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Dermagraft ® – Related to LCD L26003
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AMA CPT / ADA
CDT Copyright Statement
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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.
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Primary
Geographic Jurisdiction
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Number
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Type
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State(s)
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00130
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FI
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IN
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00131
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FI
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IL
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00160
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FI
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KY
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00180
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FI
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ME
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00181
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FI
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MA
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00270
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FI
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NH, VT
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00308
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FI
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CT, DE, NY
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00332
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FI
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OH
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00450
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FI
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WI
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00452
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FI
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MI
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00453
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FI
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VA, WV
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00454
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FI
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AS, CA, CNMI, GU,
HI, NV
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00630
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Carrier
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IN
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00660
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Carrier
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KY
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00805
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Carrier
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NJ
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13101
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MAC
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CT – Part A
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13102
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MAC
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CT – Part B
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13201
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MAC
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NY – Part A
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13202
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MAC
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NY – Part B
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13282
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MAC
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NY- Part B
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13292
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MAC
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NY – Part B
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Original
Article Effective Date
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12/01/2007
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Article
Revision Effective Date
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07/18/2008
Revision Ending Date
09/30/2008
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Article
Text
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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
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707.12
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ULCER OF CALF
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707.13
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ULCER OF ANKLE
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707.14
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ULCER OF HEEL AND
MIDFOOT
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707.15
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ULCER OF OTHER PART OF FOOT,
TOES
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Secondary ICD-9 Codes
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250.80
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Diabetes, type II or unspecified type, not stated as
uncontrolled, with other specified manifestations
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250.81
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Diabetes, type I, not stated as controlled, with other
specified manifestations
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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.
- 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:
Claims for the use of Dermagraft ® must contain
both a primary and secondary diagnosis as listed below.
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Coverage
Topic
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Surgical Services
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