L28985-LCD

LCD/NCD Portal

Local Coverage Determination (LCD) for Skin Substitutes (L28985)

Contractor Information

Contractor Name First Coast Service Options,Inc.

Contractor Number 09101

Contractor Type

MAC - Part A

LCD Information

Document Information

LCD ID Number L28985

LCD Title Skin Substitutes

Contractor's Determination Number

ASKINSUB

AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental

Association.

Primary Geographic Jurisdiction Florida

Oversight Region

Region IV

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 07/01/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive

manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in

interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart

D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security

Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Change Request 6492, Transmittal 107 dated May 22, 2009, July 2009 Update of the Hospital Outpatient

Prospective Payment System (OPPS)

Change Request 6996, Transmittal 1980, dated June 4, 2010, July 2010 Update of the Hospital Outpatient

Prospective Payment System (OPPS)

Change Request 7443, Transmittal 2234, July 2011 Update of the Hospital Outpatient Prospective Payment

System (OPPS), dated May 27, 2011.

Indications and Limitations of Coverage and/or Medical Necessity

Tissue-engineered skin substitutes (i.e. human skin equivalents, dermal substitute tissues) are products that use

living cells (e.g., fibroblasts and keratinocytes) or other collagen-derived or biologically-derived extracellular

matrix in a scaffold of natural, biodegradable or synthetic matrices to foster wound healing. The scaffold provides

a stable framework that guides tissue integration and development. The scaffold is also able to bind autologous

proteins which influence cell migration and adherence. Skin substitutes are indicated in the treatment of wounds

that have not responded to aggressive, conventional wound therapy, or as outlined in the indications given

below.

Apligraf ®

Apligraf® is supplied a living, bilayered, skin substitute. 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 1 collagen lattice. While matrix proteins and cytokines found in human skin are present in Apligraf®, it does

not contain langerhans cells, melanocytes, macrophages, lymphocytes, blood vessels, or hair follicles. Apligraf®

is supplied sealed in a heavy gauge polyethylene bag intended for single use as a circular disk approximately 7.5

centimeters (cm) in diameter.

Apligraf® should be applied to a clean, debrided, thoroughly irrigated wound. Oozing or bleeding should be

stopped through the use of gentle pressure. (See package insert for application instructions.)

The wound should be inspected and the dressing changed at weekly intervals. Highly exudative wounds may

require more frequent dressing changes. Additional applications of Apligraf® may be necessary. Non-adherent

remnants should be gently removed, the wound bed cleansed, and additional applications applied. Additional

applications should not be placed over adherent areas. Healing tissue or adherent Apligraf® should not be

disrupted.

FCSO Medicare will consider Apligraf® medically reasonable and necessary for the following two FDA approved

indications:

· When used with standard therapeutic compression for the treatment of non-infected partial and/or full-thickness

skin loss ulcers due to venous insufficiency of greater than one month duration and which have not adequately

responded to conventional ulcer therapy; or

· When used with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot

ulcers of greater than three weeks duration which have not adequately responded to conventional diabetic foot

ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

Venous Leg Ulcer

Coverage for Apligraf® for venous insufficiency ulcers will be considered when ALL of the following conditions are

met:

· The venous stasis ulcer has been present for greater than one month duration; and

· The venous stasis ulcer must have failed to respond to documented conservative measures of at least four

weeks duration. Conservative measures include debridement of necrotic tissue to promote healing. Debridement

can take the form of wet-to-dry dressings, the use of enzymatic debridement (e.g., Elase, Travase), the

application of dressings that enhance leukocyte migration for shallow wounds, or surgical debridement. A moist

wound-healing environment must be provided. Excess wound exudate must be removed at each dressing change.

Clinical infections must be eradicated. Graduated venous compression must be applied to eliminate edema.

Possible choices for compression include elastic stockings with at least 35 mm of compression, Zinc oxide

bandages changed weekly, multilayer elastic wraps, and intermittent mechanical compression. Prior to Apligraf®

application, it is expected the medical record documentation will contain evidence that the conservative measures

have failed as evidenced by an ulcer that has increased in size or 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 (lack of granulation

or progress toward closing); and

· The venous stasis ulcer is confirmed as being either partial or full thickness and free of infection. The ulcer must

be free of cellulitis, eschar or obvious necrotic material as this will interfere with the device adherence and wound

healing; and

· The patient must have adequate arterial blood supply to support tissue growth.

Diabetic Foot Ulcers:

Coverage for Apligraf® for neuropathic diabetic foot ulcers will be considered when ALL of the following conditions

are met:

· The type 1 or type 2 diabetic is under current medical management; and

· The full thickness neuropathic diabetic foot ulcer has been present for a minimum of three weeks duration; and

· The neuropathic diabetic foot ulcer must have failed to respond to documented conservative measures of at

least four weeks duration. Conservative measures include aggressive sharp or surgical debridement of necrotic

tissue, saline moistened dressings and a non-weight-bearing regime. Clinical infections must be eradicated. Prior

to Apligraf® application, it is expected the medical record documentation will contain evidence that the

conservative measures have failed as evidenced by an ulcer that has increased 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 (lack of granulation or progress toward closing); and

· The neuropathic diabetic foot ulcer 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;

and

· The patient must have adequate arterial blood supply to support tissue growth.

Apligraf® is contraindicated:

· For use on clinically infected wounds;

· In patients with known allergies to bovine collagen; or

· In patients with known hypersensitivity to the components of the Apligraf® agarose shipping medium (See

product label).

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, Povodine-iodine solution, Chlorhexidine, or Polymixin/Nystatin. The use of

Apligraf® with these solutions will be considered not medically reasonable and necessary, and will result in denial

of reimbursement. Additional applications of Apligraf® may be required to achieve adequate wound closure, but

should be limited to no more than five applications per wound.

Dermagraft®

Dermagraft® is a cryopreserved dermal substitute composed of human fibroblasts, extracellular matrix, and a

bioabsorbable scaffold. During the manufacturing process, the human fibroblasts are seeded into a bioabsorbable

polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human

dermal collagen, matrix proteins, growth factors and cytokines to create a three-dimensional human dermal

substitute containing metabolically active, living cells.

Dermagraft® is supplied frozen in a clear bag containing one piece of approximately 2 inches x 3 inches (5 cm x

7.5 cm) intended for a single use application. After the thawing process, Dermagraft® is applied to clean wounds

in which any necrotic or hyperkeratinized tissue has been debrided and no active bleeding is present. Following

the initial application, the wound is covered with an appropriate non-adherent dressing. Dressing changes should

occur initially 72 hours after the first application and then daily, or as needed thereafter. Additional applications

of Dermagraft® may be applied weekly, or until wound closure occurs. Dermagraft® should not be applied for

more than 8 applications over a 12 week period for the treatment of any given lesion. (See product label for 24-

steps involved in the correct use of this product.)

FCSO Medicare will consider Dermagraft® medically reasonable and necessary for the following indication:

· Treatment of full thickness diabetic foot ulcers.

Coverage for Dermagraft® used in the treatment of full thickness diabetic foot ulcers will be considered when ALL

of the following conditions are met:

· The patient has documented type 1 or type 2 diabetes and is currently receiving medical management for this

condition; and

· The full thickness diabetic foot ulcer has been present for a minimum of six weeks duration; and

· The ulcer has failed to respond to conservative measures such as non-weight bearing regimen, debridement of

necrotic and callused tissue, and acceptable methods of wound care; and

· The ulcer extends through the dermis, but does not involve tendon, muscle, joint capsule, or have bone

exposure; and

· The patient must have an adequate arterial blood supply to the foot in order to support tissue growth as

evidenced by a palpable pulse on the foot (either dorsalis pedis or posterior tibial artery).

Dermagraft® is contraindicated for use in patients with:

· Signs of clinical infection (e.g., increased exudates, odor, redness, swelling, heat, pain, tenderness, purulent

discharge);

· Ulcers with sinus tracts;

· Patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins

from the manufacturing medium and storage solution.

The use of Dermagraft® in the treatment of full thickness diabetic ulcers has not been studied in patients

receiving greater than 8 applications, children under the age of 18, pregnant women, patients with ulcers over a

Charots deformity of the midfoot or patient receiving immunosuppressive or cytotoxic agents, and is not indicated

when these conditions are present.

Any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, ointments, creams, or gels) on an

ulcer being treated with Dermagraft® may reduce the viability of the product. The use of Dermagraft® in

conjunction with these solutions will be considered not reasonable and necessary and will result in denial of

reimbursement.

Integra® Dermal Regeneration Template (DRT)

Integra® DRT is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a

porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that

is manufactured with a controlled porosity and defined degradation rate. The temporary epidermal substitute

layer is made of synthetic polysiloxane polymer (silicone) and functions to control moisture loss from the wound.

The collagen dermal replacement layer serves as a matrix for the infiltration of fibroblasts, macrophages,

lymphocytes, and capillaries derived from the wound bed.

Integra® DRT is used for the treatment of deep partial-thickness or full-thickness thermal injury to the skin. It is

applied following excision of the burn wound to viable tissue. It serves two critical functions:

· As an "artificial skin" that provides immediate postexcisional wound homeostasis;

· As a template to generate "neodermis," a dermal-like tissue that readily accepts very thin epidermal autografts.

Formation of the neodermis typically takes 14-21 days. After the neodermis is formed, the silicone layer is easily

removed and a very thin meshed and widely spread epidermal autograft can be applied over the neodermis.

These thin epidermal autografts result in less donor site morbidity than conventional split-thickness autografts.

Since the epidermal autograft can be applied immediately after the neodermis has formed, the application of the

epidermal autograft can also be scheduled at a time when sufficient donor sites are available and/or the patient's

condition is suitable for the grafting procedure. In a multicenter clinical trial, Integra® DRT remained in place

successfully for up to 73 days prior to epidermal autografting.

Medicare will consider Integra® DRT medically reasonable and necessary for the following indication:

· Post-excisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where

sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of

the patient.

Excision of the wound must be performed thoroughly to remove all coagulation eschar and nonviable tissue.

Integra® DRT will not take to nonviable tissue. Leaving any remaining nonviable tissue may create an

environment for bacterial growth. Hemostatis must be achieved prior to applying Integra® DRT. Inadequate

control of bleeding will interfere with the incorporation of this product. Integra® DRT should be applied on the

day of excision.

Integra® DRT should not be used on patients with known allergies to cow collagen or in patients with clinically

diagnosed infected wounds.

OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix

OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix are biologically derived extracellular matrix-based

wound products that are compatible with human tissue. Unlike other collagen-based wound care materials,

OASIS® is a complex scaffold that provides an optimal environment for a favorable host tissue response, a

response characterized by restoration of tissue structure and function. OASIS® Wound Matrix and OASIS® Ultra

Tri-Layer Matrix are comprised of porcine-derived acellular small intestine submucosal (SIS) for use in wound

management.

FCSO Medicare will consider OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix reasonable and medically

necessary for the following indications:

· Partial and full-thickness wounds (neuropathic diabetic foot or venous stasis ulcers)

· Venous ulcers

· Diabetic ulcers

Coverage for OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix for venous stasis ulcers (VSU) will be

considered when ALL the following conditions are met:

· The venous stasis ulcer has been present for greater than one month duration; and

· The venous stasis ulcer has failed to respond to documented conservative measures of at least four weeks

duration. 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 and at completion of at least four weeks of standard conservative

management. Documentation should also include measurement of the ulcer immediately prior to the placement

of OASIS Wound Matrix. Conservative methods of wound care include wound tissue hydration with saline, nonadherent

dressings, moisture-donating or absorptive dressing (depending on amount of exudate), and compression wraps.

Coverage for OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix for neuropathic diabetic foot ulcers (DFU)

will be considered when ALL the following conditions are met:

· The patient is currently under management for either Type I or Type II diabetes mellitus; and

· The non-healing diabetic foot ulcer has been present for greater than one month and has a viable wound bed

with granulation tissue present; and

· Standard conservative wound care measures have been tried. Conservative measures include removal of

mechanical stress, debridement of necrotic tissue if present, and saline moistened dressings; and

· The ulcer is located on the foot or toes that are free of exposed bone, tendon, or fascia.

OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix are contraindicated for patients with known sensitivity

to porcine material and for use in third degree burns.

The use of OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix on infected wounds, woundswith excessive

exudates, bleeding, acute swelling, cellulitis, osteomyelitis, necrotic ulcer, bone exposed wound bed, or clinically

significant lack of wound healing due to uncontrolled diabetes is not considered medically reasonable and

necessary, and will result in denial of the claim.

The use of OASIS® Ultra Tri-Layer Matrix should only be used on large problematic wounds requiring larger

thicker applications of OASIS®. Minimal to no wastage would be expected when using OASIS® Ultra Tri-Layer

Matrix for these type wounds.

Coverage will not be provided under this LCD for any wound treatment that does not meet the definition of

C9365, Q4101, Q4102, Q4105, or Q4106. All other such products will be considered to be, at most, “biologic

wound dressings” which are included in the Evaluation and Management (E/M) service and should not be billed

separately.

Coding Information

Bill Type Codes:

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.

013x Hospital Outpatient

022x Skilled Nursing - Inpatient (Medicare Part B only)

023x Skilled Nursing - Outpatient

075x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF)

085x Critical Access Hospital

Revenue Codes:

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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

Note: For graft preparation and application, see attached “Coding Guidelines”.

A new service or procedure that has been issued a CPT/HCPCS code or is FDA approved does not, in itself, make

the procedure "medically reasonable and necessary." It is the policy of the Medicare Administrative Contractor

(MAC) jurisdiction 9 (J9), that new services, procedures, technologies must be evaluated and approved either

nationally or by the MAC J9 medical policy staff before they are considered Medicare covered services.

Q4101 APLIGRAF, PER SQUARE CENTIMETER

Q4102 OASIS WOUND MATRIX, PER SQUARE CENTIMETER

Q4105 INTEGRA DERMAL REGENERATION TEMPLATE (DRT), PER SQUARE CENTIMETER

Q4106 DERMAGRAFT, PER SQUARE CENTIMETER

Q4124 OASIS ULTRA TRI-LAYER WOUND MATRIX, PER SQUARE CENTIMETER

The following HCPCS codes are not separately payable and are considered not medically reasonable

and necessary products:

C9368 Grafix core, per square centimeter

C9369 Grafix prime, per square centimeter

Acceptable literature supporting use of any of the below not medically reasonable and necessary products may be

submitted with a formal reconsideration request to this LCD. Refer to the reconsideration process outlined on the

website http://medicare.fcso.com

NOTE: An Advance Beneficiary Notice (ABN) is required for items and services not covered by Medicare due to

being considered not medically reasonable and necessary. The beneficiary should be thoroughly educated about

the benefits and risks of this item or service. If such notice is not given, providers may not shift financial liability

for such items or services to beneficiaries should a claim for such items or services be denied by Medicare.

C9363 SKIN SUBSTITUTE, INTEGRA MESHED BILAYER WOUND MATRIX, PER SQUARE CENTIMETER

C9366 EPIFIX, PER SQUARE CENTIMETER

C9367 SKIN SUBSTITUTE, ENDOFORM DERMAL TEMPLATE, PER SQUARE CENTIMETER

Q4100 SKIN SUBSTITUTE, NOT OTHERWISE SPECIFIED

Q4103 OASIS BURN MATRIX, PER SQUARE CENTIMETER

Q4104 INTEGRA BILAYER MATRIX WOUND DRESSING (BMWD), PER SQUARE CENTIMETER

Q4107 GRAFTJACKET, PER SQUARE CENTIMETER

Q4108 INTEGRA MATRIX, PER SQUARE CENTIMETER

Q4110 PRIMATRIX, PER SQUARE CENTIMETER

Q4111 GAMMAGRAFT, PER SQUARE CENTIMETER

Q4112 CYMETRA, INJECTABLE, 1CC

Q4113 GRAFTJACKET XPRESS, INJECTABLE, 1CC

Q4114 INTEGRA FLOWABLE WOUND MATRIX, INJECTABLE, 1CC

Q4115 ALLOSKIN, PER SQUARE CENTIMETER

Q4117 HYALOMATRIX, PER SQUARE CENTIMETER

Q4118 MATRISTEM MICROMATRIX, 1 MG

Q4119 MATRISTEM WOUND MATRIX, PER SQUARE CENTIMETER

Q4120 MATRISTEM BURN MATRIX, PER SQUARE CENTIMETER

Q4121 THERASKIN, PER SQUARE CENTIMETER

Q4122 DERMACELL, PER SQUARE CENTIMETER

Q4123 ALLOSKIN RT, PER SQUARE CENTIMETER

Q4125 ARTHROFLEX, PER SQUARE CENTIMETER

Q4126 MEMODERM, PER SQUARE CENTIMETER

Q4127 TALYMED, PER SQUARE CENTIMETER

Q4128 FLEXHD OR ALLOPATCH HD, PER SQUARE CENTIMETER

Q4129 UNITE BIOMATRIX, PER SQUARE CENTIMETER

Q4130 STRATTICE TM, PER SQUARE CENTIMETER

ICD-9 Codes that Support Medical Necessity

Apligraf® (Q4101)

250.80 - 250.83 DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED

454.0 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER

454.2 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION

459.31 CHRONIC VENOUS HYPERTENSION WITH ULCER

459.33 CHRONIC VENOUS HYPERTENSION WITH ULCER AND INFLAMMATION

707.10 - 707.19 UNSPECIFIED ULCER OF LOWER LIMB - ULCER OF OTHER PART OF LOWER LIMB

707.8 CHRONIC ULCER OF OTHER SPECIFIED SITES

OASIS® Wound Matrix (Q4102)and OASIS® Ultra Tri-layer Matrix (Q4124)

250.80 - 250.83 DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED

454.0 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER

454.2 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION

459.31 CHRONIC VENOUS HYPERTENSION WITH ULCER

459.33 CHRONIC VENOUS HYPERTENSION WITH ULCER AND INFLAMMATION

707.10 - 707.19 UNSPECIFIED ULCER OF LOWER LIMB - ULCER OF OTHER PART OF LOWER LIMB

707.8 CHRONIC ULCER OF OTHER SPECIFIED SITES

Integra® DRT (Q4105)

941.30 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF

FACE AND HEAD

941.31 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF EAR (ANY PART)

941.34 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF CHIN

941.35 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF NOSE (SEPTUM)

941.36 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF SCALP (ANY PART)

941.37 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF FOREHEAD AND

CHEEK

941.38 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF NECK

941.39 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF MULTIPLE SITES

(EXCEPT WITH EYE) OF FACE HEAD AND NECK

941.40 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF

UNSPECIFIED SITE OF FACE AND HEAD WITHOUT LOSS OF BODY PART

941.41 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF EAR

(ANY PART) WITHOUT LOSS OF EAR

941.44 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF CHIN

WITHOUT LOSS OF CHIN

941.45 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF NOSE

(SEPTUM) WITHOUT LOSS OF NOSE

941.46 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF SCALP

(ANY PART) WITHOUT LOSS OF SCALP

941.47 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF

FOREHEAD AND CHEEK WITHOUT LOSS OF FOREHEAD AND CHEEK

941.48 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF NECK

WITHOUT LOSS OF NECK

941.49

DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF

MULTIPLE SITES (EXCEPT WITH EYE) OF FACE HEAD AND NECK WITHOUT LOSS OF A BODY

PART

941.50 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF FACE

AND HEAD UNSPECIFIED SITE WITH LOSS OF BODY PART

941.51 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF EAR

(ANY PART) WITH LOSS OF EAR

941.54 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF CHIN

WITH LOSS OF CHIN

941.55 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF NOSE

(SEPTUM) WITH LOSS OF NOSE

941.56 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF SCALP

(ANY PART) WITH LOSS OF SCALP

941.57 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF

FOREHEAD AND CHEEK WITH LOSS OF FOREHEAD AND CHEEK

941.58 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF NECK

WITH LOSS OF NECK

941.59 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF

MULTIPLE SITES (EXCEPT EYE) OF FACE HEAD AND NECK WITH LOSS OF A BODY PART

942.20 - 942.29 BLISTERS WITH EPIDERMAL LOSS DUE TO BURN (SECOND DEGREE) OF UNSPECIFIED SITE

OF TRUNK - BLISTERS WITH EPIDERMAL LOSS DUE TO BURN (SECOND DEGREE) OF OTHER AND MULTIPLE SITES OF TRUNK

942.30 - 942.39 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF

TRUNK - FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF OTHER AND MULTIPLE SITES OF TRUNK

942.40 - 942.49 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF TRUNK

UNSPECIFIED SITE WITHOUT LOSS OF BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF OTHER AND MULTIPLE SITES OF TRUNK WITHOUT LOSS OF BODY PART

942.50 - 942.59 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF TRUNK WITH LOSS OF BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF OTHER AND MULTIPLE SITES OF TRUNK WITH LOSS OF A BODY PART

943.30 - 943.39 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF

UPPER LIMB - FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF MULTIPLE SITES OF UPPER LIMB EXCEPT WRIST AND HAND

943.40 - 943.49 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF UPPER LIMB WITHOUT LOSS OF A BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES OF UPPER LIMB EXCEPT WRIST AND HAND WITHOUT LOSS OF UPPER LIMB

943.50 - 943.59 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF UPPER LIMB WITH LOSS OF A BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES OF UPPER LIMB EXCEPT WRIST AND HAND WITH LOSS OF UPPER LIMB

944.30 - 944.38 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF HAND - FULL THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF MULTIPLESITES OF WRIST(S) AND HAND(S)

944.40 -944.48 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF HAND WITHOUT LOSS OF HAND - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES OF WRIST(S) AND HAND(S) WITHOUT LOSS OF A BODY PART

944.50 -944.58 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF HAND WITH LOSS OF HAND - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES OF WRIST(S) AND HAND(S) WITH LOSS OF A BODY PART

945.20 - 945.29 BLISTERS EPIDERMAL LOSS (SECOND DEGREE) OF UNSPECIFIED SITE OF LOWER LIMB (LEG) - BLISTERS WITH EPIDERMAL LOSS DUE TO BURN (SECOND DEGREE) OF MULTIPLE SITES OF LOWER LIMB(S)

945.30 - 945.39 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF LOWER LIMB - FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF MULTIPLE SITES OF LOWER LIMB(S)

945.40 - 945.49 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF LOWER LIMB (LEG) WITHOUT LOSS OF A BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES OF LOWER LIMB(S) WITHOUT LOSS OF A BODY PART

945.50 - 945.59 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE LOWER LIMB (LEG) WITH LOSS OF A BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES OF LOWER LIMB(S) WITH LOSS OF A BODY PART

946.0 - 946.5 BURNS OF MULTIPLE SPECIFIED SITES UNSPECIFIED DEGREE - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SPECIFIED SITES WITH LOSS OF A BODY PART

948.00 - 948.99 BURN (ANY DEGREE) INVOLVING LESS THAN 10 PERCENT OF BODY SURFACE WITH THIRD DEGREE BURN OF LESS THAN 10 PERCENT OR UNSPECIFIED AMOUNT - BURN (ANY DEGREE) INVOLVING 90 PERCENT OR MORE OF BODY SURFACE WITH THIRD DEGREE BURN OF 90% OR MORE OF BODY SURFACE

949.3 FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) UNSPECIFIED SITE

949.4 DEEP NECROSIS OF UNDERLYING TISSUE DUE TO BURN (DEEP THIRD DEGREE) UNSPECIFIED SITE WITHOUT LOSS OF A BODY PART

949.5 DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE UNSPECIFIED SITE WITH LOSS OF A BODY PART

Dermagraft® (Q4106)

250.80 - 250.83 DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED

707.14 ULCER OF HEEL AND MIDFOOT

707.15 ULCER OF OTHER PART OF FOOT

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this

Local Coverage Determination.

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this Local Coverage Determination.

General Information

Documentations Requirements

Medical record documentation maintained by the treating provider must substantiate the medical necessity of the

services being billed. In addition, documentation that the service was performed must be included in the patient’s

medical record. This information is normally found in the history and physical, office/progress notes, hospital

notes, and/or procedure report.

The medical record must clearly show that the criteria listed under the “Indications and Limitations of Coverage

and/or Medical Necessity” sections have been met, as well as, the appropriate diagnosis and response to

treatment. Description of the wound must be documented at baseline (prior to beginning conservative treatment)

relative to size, location, stage, duration, and presence of infection, in addition to type of treatment given and

response. This information must be updated throughout treatment. Wound description must also be documented

pre and post treatment with the skin substitute being used. If obvious signs of worsening or lack of treatment

response is noted, continuing treatment with the skin substitute would not be considered medically reasonable

and necessary without documentation of a reasonable rational for doing so.

Documentation must support FDA labeling (where applicable), including the criteria, frequency, and acceptable

duration of treatment for any skin substitute product billed.

Since application of Apligraf, OASIS® Wound Matrix and OASIS® Ultra Tri-Layer Matrix, Integra DRT, and

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 non-advance practice nurses,

therapists or medical assistants.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical

literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to medical review.

The safety and effectiveness of Apligraf® have not been established for patients receiving more than five device

applications.

The use of Dermagraft® is limited to no more than 8 applications per treatment site over a 12 week period.

The safety and effectiveness of re-treatment of a single wound using Apligraf® or Dermagraft® has not been

established and is not covered.

Sources of Information and Basis for Decision

Advanced BioHealing, Inc. (2007). Product information on Dermagraft: directions for use. LaJolla, CA

Angirasa, A., Willrich, A., Cooper, B., Stuck, R. (2006). Combining bioengineered human dermal replacement and

multilayered compression dressings to manage ulcers in a person with diabetes. Ostomy Wound Management,

52: 5.

Fryberg, R. G., Armstrong, D. G., Giurini, J., Edwards, A., Karvette, M., Kravitz, S., Ross, C., Stovosky, J., Stuck,

R. & Vanore, J. (2000). Diabetic foot disorders, a clinical practice guideline. The American College of Foot and

Ankle Surgeons, and The American College of Foot and Ankle Orthopedic and Medicine. Park Ridge, IL. This

source was used to provide a device description and clinical indications for the use of the product.

Food and Drug Administration, Medical Device Reporting. (2001). Summary of Safety and Effectiveness Data:

Dermagraft®. Author. Rockville, MD. This source was used to provide indications and contraindications for use.

Food and Drug Administration, Medicare Device Reporting. (2008). Premarket Approval Database, Integra®

Dermal Regeneration Template.

Food and Drug Administration, 510(k) Premarket notification summary. (2008). IntegraTM Meshed Bilayer Wound

Matrix.

Food and Drug Administration, Tissue and tissue products, 2011

Hanft, J. R., & Surprenant, M. S. (2002). Healing of chronic foot ulcers in diabetic patients treated with a human

fibroblast-derived dermis. Journal of Foot and Ankle Surgery,41, (5) 291-299. This source was used as a

reference for indications and contraindicated conditions.

Healthpoint, Ltd. (2011). Product information on OASIS® Ultra Tri-Layer Matrix. Cook BioTech, Inc.

Integra Life Sciences Corp. (2004). Integra® prescribing information [Brochure]. Plainsboro, New Jersey: Author.

This source was used to provide a description of and indications for use of the product.

Medicare Coverage Database

Mostow, E.N., Haraway, G.D., Dalsing, M., Hodde, J.P., King, D. (2005). Effectiveness of an extracellular matrix

graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. Journal of Vascular

Surgery, 41 (5): 837-43.

National Guideline Clearinghouse. (2004). Guideline for management of wounds in patients with lower-extremity

neuropathic disease. Available: http://www.guideline.gov

Niezgoda, J.A., Van Gils, C.C., Frykberg, R.G., & Hodde, J.P. (2005). Randomized Clinical Trial Comparing OASIS

Wound Matrix to Regranex Gel for Diabetic Ulcers. Advances in Skin & Wound Care, 18 (5):258-66.

Novartis Pharmaceuticals Corp. (2002). Apligraf® prescribing information. [Brochure]. East hanover, New Jersey:

Author. This source was used to provide a description of and indications for use of the product.

Organogenesis, Inc. (2006). Apligraf product lael. Received from Apligraf medical information center, Canton, MA

on January 6, 2009.

Rakel, R.E. (Eds.). (2000). Saunders manual of medical practice (2nd ed.). Philadelphia, PA: W.B. Saunders

Company. Used to determine diagnosis and conservative treatment.

Smith & Nephew, Inc. Wound Management Division. (2001). Dermagraft® human fibroblast-derived dermal

substitute; directions for use. [Brochure]. Largo, FL: Author. This source was used to provide a description for the

use of the product.

Smith & Nephew, Inc. Wound Management (2002). TranCyte Human Fibroblast-Derived Temporary Skin

Substitute; Direction for use [Brochure] LaJolla, CA: Author.

Towsend, C. M. (Ed.). (2001). Sabiston textbook of surgery: the biological basis of modern surgical practice (16th

ed.). (pp. 355-356). St. Louis, MO. W.B. Sanders. This source was used to provide indications for treatment of

burn patients.

University of Pennsylvania School of Medicine. (2000) Venous leg ulcer guideline. [On-line]. Available:

http://www.guideline.gov/VIEWS/summary.a…rief_summary&sSearch_string=venous+ulcer. Used to determine

conservative treatment.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of

the contractor or contractor medical director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous specialties.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 04/01/2011

Revision History Number 11

Revision History Explanation Revision Number:11

Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2012

Revised Effective Date: 07/01/2012

LCR A2012-047

June 2012 Connection

Explanation of Revision: Change request 7847, Transmittal 2483, July 2012 Update of the Hospital Outpatient

Prospective Payment System (OPPS), dated June 8, 2012, new HCPCS codes C9368 and C9369 were developed.

After further evaluation a decision was made to add HCPCS codes C9368 and C9369 to the “CPT/HCPCS Codes”

section under subsection “The following HCPCS codes are not separately payable and are considered not

medically reasonable and necessary products:” of the LCD. The effective date of this revision is based on date of

service.

Revision Number:10

Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012

Revised Effective Date: 01/01/2012

LCR A2012-018

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. Under the “CPT/HCPCS Codes” section, HCPCS code C9365

was replaced with HCPCS code Q4124. Under the subsection of the “CPT/HCPCS Codes” section for “The following

HCPCS codes are not separately payable and are considered not medically reasonable and necessary products:”,

HCPCS codes C9366, Q4122, Q4123, Q4125, Q4126, Q4127, Q4128, Q4129, and Q4130 were added. In addition,

the “Sources of Information and Basis for Decision” section was updated, and the “Coding Guidelines” attachment

was revised. The effective date of this revision is based on date of service.

Revision Number:9

Start Date of Comment Period:N/A

Start Date of Notice Period:12/01/2011

Revised Effective Date: 11/30/2011

LCR A2011-087

November 2011 Connection

Explanation of Revision: A revision was made to the LCD to include: “OASIS® Ultra Tri-Layer Matrix” with

“OASIS® Wound Matrix” in all applicable sections of the LCD. Under the “Indications and Limitations of Coverage

and/or Medical Necessity” section for “OASIS® Wound Matrix,” Language was revised to include coverage for

HCPCS code C9365 for OASIS® Ultra Tri-Layer Matrix,” the contraindications were updated, and other specified

indications for OASIS® Ultra Tri-Layer Matrix were given. Under the “CPT/HCPCS Codes” section, HCPCS code

C9365 with descriptor was added, and under the HCPCS codes that are not separately payable and considered

not medically reasonable and necessary products, HCPCS code C9365 with descriptor was deleted. In addition,

the “Sources of Information and Basis for Decision” section was updated. The effective date of this LCD revision is

based on date of service.

Revision Number:8

Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2011

Revised Effective Date: 07/01/2011

LCR A2011-053

June 2011 Connection

Explanation of Revision: Under the “CPT/HCPCS Codes” section of the LCD, under the subsection “The following

HCPCS codes are not separately payable and are considered not medically reasonable and necessary products:”

HCPCS code C9365 was added based on the July 2011 OPPS Update. The effective date of this revision is based

on date of service.

Revision Number:7

Start Date of Comment Period:N/A

Start Date of Notice Period:04/01/2011

Revised Effective Date: 02/13/2011

LCR A2011-030

March 2011 Bulletin

Explanation of Revision: Under the “CPT/HCPCS Codes” section of the LCD, verbiage was revised to state the not

separately payable HCPCS codes are considered “not medically reasonable and necessary” products, and a

statement regarding ABN information was added. The effective date of this LCD is based on date of service.

Revision Number:6

Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2011

Revised Effective Date: 01/01/2011

LCR A2011-020

December 2010 Bulletin

Explanation of Revision: Annual 2011 HCPCS Update. Descriptor revised for HCPCS codes and code ranges Q4101

-Q4108; Q4110-Q4113; and Q4115. HCPCS code Q4109 was deleted under the “Non-Covered Products” subsection

of the “CPT/HCPCS Codes” section of the LCD, and HCPCS code range Q4117-Q4121 with descriptors

were added under the “Non-Covered Products” sub-section of the “CPT/HCPCS Codes” section. The effective date

of this revision is based on date of service

Revision Number:5

Start Date of Comment Period:N/A

Start Date of Notice Period:08/01/2010

Revised Effective Date: 07/01/2010

LCR A2010-035

July 2010 Bulletin

Explanation of Revision: Based on CR6996, July 2010 Update of the Hospital OPPS, HCPCS code C9367 was

added to the Non-Covered Products section under the “CPT/HCPCS Codes” section of the LCD. The effective date

of this LCD revision is for claims processed on or after 07/06/10, for dates of service on or after 07/01/10.

Revision Number:4

Start Date of Comment Period:N/A

Start Date of Notice Period:03/01/2010

Revised Effective Date: 02/04/2010

LCR A2010-020

February 2010 Bulletin

Explanation of Revision: Under the last paragraph of the “Indications and Limitations of Coverage and/or Medical

Necessity” section of the LCD, deleted the following sentence: “All other such products, unless they are

specifically FDA labeled as “Skin substitutes” and for use in the types of ulcers considered in this LCD will be

denied coverage under this LCD.” Added “other” to “All such products” in the next sentence. The effective date of

this revision is based on date of service.

Revision Number:3

Start Date of Comment Period:N/A

Start Date of Notice Period:11/01/2009

Revised Effective Date:10/01/2009

LCR A2009-082

October 2009 Bulletin

Explanation of Revision: Based on CR 6626 for the October 2009 Hospital OPPS, HCPCS code Q4115 was added

to the Non-Covered Products under the “CPT/HCPCS Codes” section of the LCD. The effective date of this revision

is based on date of service.

Revision Number:2

Start Date of Comment Period:N/A

Start Date of Notice Period:08/01/2009

Revised Effective Date: 07/01/2009

LCR A2009-064

July 2009 Bulletin

Explanation of Revision: Based on CR 6492 for the July 2009 Hospital OPPS, HCPCS code C9363 was added to the

Non-Covered Products under the “CPT/HCPCS Codes” section of the LCD. In addition, under the “Type of Bill

Code” section of the LCD, 22x was added, and the “Sources of Information and Basis for Decision” section of the

LCD was updated. The effective date of this LCD revision is based on date of service.

Revision Number:1

Start Date of Comment Period:02/20/2009

Start Date of Notice Period:05/01/2009

Revised Effective Date: 06/30/2009

LCR A2009-053

April 2009 Bulletin

Explanation of Revision: This LCD is being presented for notice and comment as a major revision to further define

and update the Skin Substitute products with the CMS codes and descriptions for specific products. Under the

“Indications and Limitations of Coverage and/or Medical Necessity” section, updated/revised language including

verbiage for Apligraf®, Dermagraft®, Integra® DRT, and OASIS® Wound Matrix. Struck out information

regarding Allograft, OrCel™, TransCyte®, and Xenograft, and removed “NOTE” with coding information. Under

the “CPT/HCPCS Codes” section, updated code and code descriptions for Q4101, Q4102, Q4105, & Q4106. Listed

HCPCS codes with descriptions that are considered Non-Covered products, and information regarding

reconsideration requests. Under the “ICD-9 Codes that Support Medical Necessity” section, the following revisions

were made: struck our headings for “Allograft or similar product (Q4100)” and all diagnoses for this code, and

“Xenograft or similar product (Q4105)” and all diagnoses for this code; revised heading for “Integra® DRT,

OrCel™, and TransCyte® or similar product (Q4101, Q4105)” to read as “Integra® DRT (Q4105) and removed

the followng diagnosis codes and code ranges: 941.20, 941.21, 941.24, 941.25, 941.26, 941.27, 941.28, 941.29,

943.20-943.29, 944.20-944.28, and 949.2. Added ICD-9-CM codes 459.31 and 459.33 to Apligraf (Q4101).

Struck out “or similar product” from all other product headings in this section. Updated/revised the

“Documentation Requirements” section, “Utilization Guidelines” section, “Sources of Information and Basis for

Decision” section, and “Coding Guidelines” attachment. The effective date of this revision is based on date of

service.

Revision Number:Original

Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008

Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary

predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28985) replaces LCD L13688 as the policy in notice. This document (L28985) is

effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed

8/1/2010 - The description for Bill Type Code 22 was changed

8/1/2010 - The description for Bill Type Code 23 was changed

8/1/2010 - The description for Bill Type Code 75 was changed

8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was

changed. Depending on which description is used in this LCD, there may not be any change in how the code

displays in the document:

Q4101 descriptor was changed in Group 1

Q4102 descriptor was changed in Group 1

Q4105 descriptor was changed in Group 1

Q4106 descriptor was changed in Group 1

Q4103 descriptor was changed in Group 2

Q4104 descriptor was changed in Group 2

Q4107 descriptor was changed in Group 2

Q4108 descriptor was changed in Group 2

Q4110 descriptor was changed in Group 2

Q4111 descriptor was changed in Group 2

Q4112 descriptor was changed in Group 2

Q4113 descriptor was changed in Group 2

Q4115 descriptor was changed in Group 2

11/21/2010 - The following CPT/HCPCS codes were deleted:

Q4109 was deleted from Group 2

11/21/2011 - The following CPT/HCPCS codes were deleted:

C9365 was deleted from Group 1

Reason for Change HCPCS Addition/Deletion