DRAFT     DRAFT     DRAFT     DRAFT     DRAFT   

Contractor Name

CareFirst of Maryland INC., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LCD Database ID Number

 DL17540

LCD Title

Skin Substitutes

Contractor’s Determination Number

04-05

AMA/CPT and ADA/CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 2004 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. CDT-4 codes and descriptions are Ó2004 American Dental Association. All rights reserved.

CMS National Coverage Policy

·Establishment of national policy supersedes all previous contractor policy statements, including Local Medical Policy coverage guidelines.

·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). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

·Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

Oversight Region

Region III

CMS Consortium

Northeast

DMERC Region LCD Covers

N/A

Original Determination Effective Date

 

Revision Effective Date

 

Indications and Limitations of Coverage and/or Medical Necessity

Several types of skin substitutes are available which are indicated for a variety of conditions. Some skin substitutes are metabolically active, others are inert. Some are a single layer, essentially replacing either the epidermal or dermal component of the skin. Others are multi-layered, and may represent a full-thickness skin replacement. Depending on the product, autograft, allograft, and xenograft elements may be used in the production of these skin substitutes. Skin substitutes may have different functions at the wound site, including maintaining a moist wound environment (essentially acting as a dressing), providing a structural support for tissue regeneration, and/or providing cellular products that promote growth in the wound bed.

Depending on the product, skin substitutes may be used in a variety of conditions. Some are applied once, others are applied at regular intervals. Some are left in place, others removed when healing has progressed. The most common uses include replacing areas of the integument damaged by burns, replacing skin in donor graft sites, treating areas of pressure ulcers, diabetic ulcers, or venous stasis ulcers. Generally the treatment of ulcers should be restricted to those that have proven recalcitrant to other treatments over at least 6 weeks. Ulcers that are showing progress in healing should not be treated with these products. Skin substitutes should be applied and reapplied, when applicable, according to the prescribing information supplied with the product. Some products also require removal at designated times.

Skin substitutes with FDA 510(k) or Pre-market Approval include the following:

Alloderm®

 

Donated freeze-dried de-cellularized human dermal tissue

Apligraft®

 

A bilayer product composed of a dermal layer made of bovine collagen and human fibroblasts, and an epidermal layer composed of human keratinocytes

BioBrane®

 

A silicon film with nylon threads embedded to which collagen has been bound

Dermagraft®

 

A dermal substitute with fibroblasts, an extracellular matrix, and a bioabsorbable scaffold

EZ Derm™

 

A porcine-derived xenograft of collagen crosslinked with aldehyde

Integra®

 

A bilayer product composed of a dermal layer of bovine collagen and chondroitan sulfate, and an epidermal synthetic polymer

Oasis®

 

A porcine-derived acellular small intestine submucosa

Orcel®

 

A bilayer product with allogeneic epidermal keratinocytes and dermal fibroblasts which is used for the donor site of a split-thickness skin graft

Transcyte®

 

A porcine dermal collagen-coated nylon mesh on a silicone membrane with human fibroblasts

Alloderm®, Biobrane®, Integra®, and Oasis® are acellular whereas the other products have cellular components.

Coverage Topic

Outpatient Hospital Services

Bill Type Codes

12X, 13X, 18X, 21X, 22X, 23X, 75X, 83X

Revenue Codes

036X, 045X, 051X, 0636, 0761

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long description of the following codes:

C1305

 

Apligraf, per 44 sq cm (OPPS only)

C9123

 

Transcyte, per 247 sq cm (OPPS only)

C9200

 

Orcel, per 36 sq cm (OPPS only)

C9201

 

Dermagraft, per 37.5 sq cm (OPPS only)

J3490

 

Unclassified drugs

J7340

 

Dermal and epidermal tissue, human, metabolically active, per sq cm

J7342

 

Dermal tissue, human, metabolically active, per sq cm

J7350

 

Dermal tissue, human, without metabolically active, per sq cm

Q0182

 

Dermal and epidermal, non-human, without metabolically active, per sq cm

Q0183

 

Dermal, of human origin, without metabolically active, per sq cm

15000

Ó

Surgical prep, recipient, first 100 sq cm

15001

Ó

Surgical prep, recipient, each additional 100 sq cm

15342

Ó

Application of bilaminate skin substitute/neodermis 25 sq cm

15343

Ó

Application of bilaminate skin substitute/neodermis, each additional 25 sq cm

Ó CPT American Medical Association

Does the "CPT 30% Coding Rule" Apply?

N/A

ICD-9-CM Codes that Support Medical Necessity

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

Medicare is establishing the following limited coverage for Alloderm®:

707.0

 

Decubitus Ulcer

941.20-

941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24-

941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.30-

941.31

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.34-

941.39

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.40-

941.41

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.44-

941.49

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.50-

941.51

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

941.54-

941.59

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

942.20- 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

942.30 - 942.39

 

Burn of trunk, full-thickness skin loss (third degree NOS)

942.40 - 942.49

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

942.50 - 942.59

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) with loss of a body part

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

943.30 - 943.39

 

Burn of upper limb, except wrist and hand, full-thickness skin loss (third degree NOS)

943.40 - 943.49

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

943.50 - 943.59

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) with loss of a body part

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

944.30 - 944.38

 

Burn of wrist(s) and hand(s), full-thickness skin loss (third degree NOS)

944.40 - 944.48

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

944.50 - 944.58

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

945.30 - 945.39

 

Burn of lower limb(s), full-thickness skin loss (third degree NOS)

945.40 - 945.49

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

945.50 - 945.59 

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

946.2 - 946.5

 

Burns of multiple specified sites

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second and/or third degree burns) 

Medicare is establishing the following limited coverage for Apligraf®:

250.80

 

Diabetes with other specified manifestations, type II, not stated as uncontrolled

250.81

 

Diabetes with other specified manifestations, type I, not stated as uncontrolled

250.82

 

Diabetes with other specified manifestations, type II, uncontrolled

250.83

 

Diabetes with other specified manifestations, type I, uncontrolled

454.0

 

Varicose veins of lower extremity, with ulcer

454.2

 

Varicose veins of lower extremity, with ulcer and inflammation

707.12

 

Ulcer of lower limb, except decubitus, calf

707.13

 

Ulcer of lower limb, except decubitus, ankle

707.14

 

Ulcer of lower limb, except decubitus, heel and midfoot

707.15

 

Ulcer of lower limb, except decubitus, other part of foot

Medicare is establishing the following limited coverage for BioBrane®:

941.20 - 941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24 - 941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

942.20 - 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

 946.2

 

Burns of multiple specified sites, blisters, epidermal loss (second degree)

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second degree burns) 

Medicare is establishing the following limited coverage for Dermagraft®:

250.80

 

Diabetes with other specified manifestations, type II, not stated as uncontrolled

250.81

 

Diabetes with other specified manifestations, type I, not stated as uncontrolled

250.82

 

Diabetes with other specified manifestations, type II, uncontrolled

250.83

 

Diabetes with other specified manifestations, type I, uncontrolled

707.14

 

Ulcer of lower limb, except decubitus, heel and midfoot

707.15

 

Ulcer of lower limb, except decubitus, other part of foot

757.39

 

Unspecified anomaly of the integument (may be used for epidermolysis bullosa)

Medicare is establishing the following limited coverage for EZ Derm™:

250.80

 

Diabetes with other specified manifestations, type II, not stated as uncontrolled

250.81

 

Diabetes with other specified manifestations, type I, not stated as uncontrolled

250.82

 

Diabetes with other specified manifestations, type II, uncontrolled

250.83

 

Diabetes with other specified manifestations, type I, uncontrolled

454.0

 

Varicose veins of lower extremity, with ulcer

454.2

 

Varicose veins of lower extremity, with ulcer and inflammation

707.0

 

Decubitus Ulcer

707.12

 

Ulcer of lower limb, except decubitus, calf

707.13

 

Ulcer of lower limb, except decubitus, ankle

707.14

 

Ulcer of lower limb, except decubitus, heel and midfoot

707.15

 

Ulcer of lower limb, except decubitus, other part of foot

941.20 - 941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24 - 941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

942.20 - 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

 946.2

 

Burns of multiple specified sites, blisters, epidermal loss (second degree)

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second degree burns) 

Medicare is establishing the following limited coverage for Integra®:

941.20- 941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24 - 941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.30 - 941.31

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.34 - 941.39

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.40 - 941.41

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.44 - 941.49

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.50 - 941.51

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

941.54 - 941.59

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

942.20 - 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

942.30 - 942.39

 

Burn of trunk, full-thickness skin loss (third degree NOS)

942.40 - 942.49

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

942.50 - 942.59

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) with loss of a body part

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

943.30 - 943.39

 

Burn of upper limb, except wrist and hand, full-thickness skin loss (third degree NOS)

943.40 - 943.49

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

943.50 - 943.59

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) with loss of a body part

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

944.30 - 944.38

 

Burn of wrist(s) and hand(s), full-thickness skin loss (third degree NOS)

944.40 - 944.48

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

944.50 - 944.58

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

945.30 - 945.39

 

Burn of lower limb(s), full-thickness skin loss (third degree NOS)

945.40 - 945.49

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

945.50 - 945.59 

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

946.2 - 946.5

 

Burns of multiple specified sites

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second and/or third degree burns) 

Medicare is establishing the following limited coverage for Oasis®:

250.80

 

Diabetes with other specified manifestations, type II, not stated as uncontrolled

250.81

 

Diabetes with other specified manifestations, type I, not stated as uncontrolled

250.82

 

Diabetes with other specified manifestations, type II, uncontrolled

250.83

 

Diabetes with other specified manifestations, type I, uncontrolled

454.0

 

Varicose veins of lower extremity, with ulcer

454.2

 

Varicose veins of lower extremity, with ulcer and inflammation

707.0

 

Decubitus Ulcer

707.12

 

Ulcer of lower limb, except decubitus, calf

707.13

 

Ulcer of lower limb, except decubitus, ankle

707.14

 

Ulcer of lower limb, except decubitus, heel and midfoot

707.15

 

Ulcer of lower limb, except decubitus, other part of foot

941.20 - 941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24 - 941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

942.20 - 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

 946.2

 

Burns of multiple specified sites, blisters, epidermal loss (second degree)

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second degree burns) 

Medicare is establishing the following limited coverage for OrCel®:

941.20 - 941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24 - 941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.30 - 941.31

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.34 - 941.39

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.40 - 941.41

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.44 - 941.49

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.50 - 941.51

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

941.54 - 941.59

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

942.20 - 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

942.30 - 942.39

 

Burn of trunk, full-thickness skin loss (third degree NOS)

942.40 - 942.49

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

942.50 - 942.59

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) with loss of a body part

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

943.30 - 943.39

 

Burn of upper limb, except wrist and hand, full-thickness skin loss (third degree NOS)

943.40 - 943.49

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

943.50 - 943.59

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) with loss of a body part

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

944.30 - 944.38

 

Burn of wrist(s) and hand(s), full-thickness skin loss (third degree NOS)

944.40 - 944.48

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

944.50 - 944.58

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

945.30 - 945.39

 

Burn of lower limb(s), full-thickness skin loss (third degree NOS)

945.40 - 945.49

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

945.50 - 945.59 

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

946.2 - 946.5

 

Burns of multiple specified sites

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second and/or third degree burns) 

Medicare is establishing the following limited coverage for Transcyte®:

941.20 - 941.21

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.24 - 941.29

 

Burn of face, head, and neck, blisters, epidermal loss (second degree)

941.30 - 941.31

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.34 - 941.39

 

Burn of face, head, and neck, full thickness skin loss (third degree NOS)

941.40 - 941.41

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.44 - 941.49

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

941.50 - 941.51

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

941.54 - 941.59

 

Burn of face, head, and neck, deep necrosis of underlying tissues (deep third degree) with loss of a body part

942.20 - 942.29

 

Burn of trunk, blisters, epidermal loss (second degree)

942.30 - 942.39

 

Burn of trunk, full-thickness skin loss (third degree NOS)

942.40 - 942.49

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

942.50 - 942.59

 

Burn of trunk, deep necrosis of underlying tissues (deep third degree) with loss of a body part

943.20 - 943.29

 

Burn of upper limb, except wrist and hand, blisters, epidermal loss (second degree)

943.30 - 943.39

 

Burn of upper limb, except wrist and hand, full-thickness skin loss (third degree NOS)

943.40 - 943.49

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

943.50 - 943.59

 

Burn of upper limb, except wrist and hand, deep necrosis of underlying tissues (deep third degree) with loss of a body part

944.20 - 944.28

 

Burn of wrist(s) and hand(s), blisters, epidermal loss (second degree)

944.30 - 944.38

 

Burn of wrist(s) and hand(s), full-thickness skin loss (third degree NOS)

944.40 - 944.48

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

944.50 - 944.58

 

Burn of wrist(s) and hand(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

945.20 - 945.29

 

Burn of lower limb(s), blisters, epidermal loss (second degree)

945.30 - 945.39

 

Burn of lower limb(s), full-thickness skin loss (third degree NOS)

945.40 - 945.49

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) without mention of loss of a body part

945.50 - 945.59 

 

Burn of lower limb(s), deep necrosis of underlying tissues (deep third degree) with loss of a body part

946.2 - 946.5

 

Burns of multiple specified sites

948.00 - 948.99 

 

Burns classified according to extent of body surface involved (Note: these codes may only be used to justify payment for skin substitutes when they include areas of second and/or third degree burns) 

 

Diagnoses that Support Medical Necessity

N/A

 

ICD-9-Codes that DO NOT Support Medical Necessity

N/A

 

Diagnoses that DO NOT Support Medical Necessity

N/A

Documentation Requirements

  • Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request. The documentation should include:
    • Diagnosis with date of onset and prior treatment, when applicable
    • Extent and severity of area to be treated
    • Skin substitute used, including number of units when applicable
  • Reevaluations should be documented on a regular basis (at least weekly initially, sooner for certain treatments).

Utilization Guidelines

·        Medicare will monitor the utilization of this service through the Medical Review process.

Sources of Information and Basis for Decision

  • American Diabetes Association (1999). Consensus Development Conference of Diabetic Foot Wound Care. Diabetes Care, 22, 1354-1360.
  • Bello, Y.M., Falabella, A. F., Eaglstein, W.H. (2001) "Tissue-Engineered Skin. Current Status in Wound Healing." American Journal of Clinical Dermatology, 2(5), 305-313.
  • Bertek Pharmaceuticals, Inc., BioBrane Prescribing Information.
  • Brem, H., Balledux, J., Sukkarieh, T., Carson, P., Falanga, V. (2001). "Healing of Venous Ulcers of Long Duration with a Bilayered Living Skin Substitute: Results from a General Surgery and Dermatology Department." Dermatologic Surgery, 27 (11), 915-9.
  • Curran, M.P., Plosker, G.L.(2002) "Bilayered Bioengineered Skin Substitute (Apligraf): A Review of Its Use in the Treatment of Venous Leg Ulcers and Diabetic Foot Ulcers." Biodrugs, 16 (6), 439-55.
  • Eisenbud, D., et al. (2004). "Skin Substitutes and Wound Healing: Current Status and Challenges." Wounds, 16(1), 2-17.
  • Falanga, V. & Sabolinski, M. (1999). "A Bilayered Living Skin Construct (Apligraf Accelerates Complete Closure of Hard-to-Heal Venous Ulcers." Wound Repair and Regeneration, 7, 201-207.
  • Hansbrough, J.F., et al. (1997) "Clinical Trials of a Biosynthetic Temporary Skin Replacement, Dermagraft-Transitional Covering, Compared with Cryopreserved Human Cadaver Skin for Temporary Coverage of Excised Burn Wounds." Journal of Burn Care and Rehabilitation, 18(1 Pt.1), 43-51.
  • Healthpoint, Ltd. (2002) Oasis Prescribing Information.
  • Integra Life Sciences Corporation. Integra Prescribing Information.
  • Marston, W.A., et al. (2003) "The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers: Results of a Prospective Randomized Trial." Diabetes Care, 26 (6), 1701-5.
  • Noordenbos, J. Dore C. , & Hanbrough, J.F. (1999) "Safety and Efficacy of TransCyte for the Treatment of Partial-Thickness Burns." Journal of Burn Care and Rehabilitation, Vol. 20, Number 4: 275-281.
  • Organogenesis, Inc. (2003) Apligraf Prescribing Information.
  • Ortec International, Inc. (2001) Orcel Instructions for Use for Managing Donor Sites in Burn Patients.
  • Phillips, T.J., et al. (2002) "The Longevity of a Bilayered Skin Substitute after Application to Venous Ulcers." Archives of Dermatology, 138 (8), 1079-81.
  • Purdue, G.F., Et al. (1997). "A Multi-Center Clinical Trial of a Biosynthetic Skin Replacement Derm TC, Compared with Cryopreserved Human Cadaver Skin for Temporary Coverage of Burn Wounds." Journal of Burn Care and Rehabilitation, Vol. 18, Number 1, Part 1, 52-57.
  • Rennekampff, H.O., Kiessig, V. Griffrey, S., Greenleaf, G. Hanbrough, J.F. (1997) "Acellular Human Dermis Promotes Cultured Keratinocyte Engraftment." Journal of Burn Care and Rehabilitation, Vol. 18, 535-44.
  • Smith & Nephew, Inc., Dermagraft Essential Prescribing Information.
  • Steed, D. (1999) "Nonoperative Management of Venous Leg Ulcers: Evolving Role of Skin Substitutes." Vascular Surgery, 33(2), 197-210.
  • TrialBlazer Health Services LCD
  • Wainwright, D. J., (1995) "Use of an Acellular Allograft Dermal Matrix (Alloderm) in the Management of Full-Thickness Burns." Burns, 21, 243-48.
  • Wainwright, D.J., et al. (1996) "Clinical Evaluation of an Acellular Allograft Dermal Martix in Full-Thickness Burns." Journal of Burn Care and Rehabilitation, Vol. 17, 124-136.
  • Waymack, P., Duff, R.G., Sabolinski, M. (2000). The Effect of a Tissue Engineered Bilayered Living Skin Analog Over Meshed Split-Thickness Autografts on the Healing of Excised Burn Wounds. The Apligraf Burn Study Group." Burns, 26 (7), 609-19.
  • List includes abstracts.

Advisory Committee Meeting Notes

This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy was developed in cooperation with representatives from wound care specialties.

Start Date if Comment Period

06/08/2004 

End Date of Comment Period

07/23/2004 

Start Date of Notice Period

 

Revision History Number

 

Revision History Explanation

 

DRAFT               DRAFT               DRAFT

 

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Italicized and or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.