20a%20alaska%20policy%20summary%20-%20n

Contractor Information

Contractor Name

Noridian Administrative Services, LLC

Contractor Number

00322

Contractor Type

FI

LCD Information

LCD ID Number

L21277

LCD Title

Application of Bioengineered Skin Substitutes: Ulcers of the Lower Extremities

Contractor's Determination Number

A2005.14 R11

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such otherdate of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current DentalTerminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) iscopyright by the American Dental Association. © 2002, 2004 American Dental Association. All rightsreserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) allows coverage and payment for only thoseservices that are considered to be medically reasonable and necessary.

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

Primary Geographic Jurisdiction

AlaskaWashington

Oversight Region

Region VIII

LCD for Application of Bioengineered Skin Substitutes: Ulcers of the Lower Extremities(L21277)

Original Determination Effective Date

For services performed on or after 12/31/2005

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2010

Revision Ending Date

Indications and Limitations of Coverage and/or Medical Necessity

Note: Providers should seek information related to National Coverage Determinations (NCD) and otherCenters for Medicare & Medicaid Services (CMS) instructions in CMS Manuals. This LCD only pertains to thecontractor's discretionary coverage related to this service.

This LCD covers the use of skin substitutes and related products in the treatment of lower extremity ulcerdisease. The LCD does not pertain or otherwise apply to the use of any skin substitutes or related products inthe treatment of burns, 940.0-949.5.

Indications

Application of Bioengineered Skin Substitutes will be covered when the following conditions are met anddocumented as appropriate for the individual patient:

1. Presence of neuropathic diabetic foot ulcers for greater than four (4) weeks' duration

2. Presence of venous stasis ulcers of greater than three (3) months’ duration that have failed to respond todocumented conservative measures for greater than two (2) months' duration

3. Presence of neuropathic diabetic foot ulcers that have failed to respond to documented conservativemeasures for greater than one (1) month's duration. These measures must include appropriate steps to off-loadpressure during treatment.

4. Presence of partial or full-thickness ulcers

5. There must be measurements of the initial ulcer size, the size following cessation of any conservativemanagement and the size at the beginning of skin substitute treatment.

6. In all cases, the ulcer must be free of infection and underlying osteomyelitis. Documentation must beprovided that these conditions have been successfully treated, resolved, prior to instituting skin substitutetreatment.

7.NAS will also cover venous stasis ulcers of the lower extremities which occur in the absence of obviousvaricosities, but which are the result of the same hemodynamic changes that commonly result in varicosities.

The expectation is that the product itself will function as a permanent replacement for the lost ordamaged skin. See Utilization Guidelines.

Limitations

Due to marked propensity for misuse of the entire range of "Skin Substitute" products, reimbursement may bemade only when the medical record clearly documents that these products have been used in a comprehensive,organized wound management program.

1. Use of the skin substitute is limited to three (3) separate applications to any given ulcer, or moreoften only when utilized with adherence to the product specific FDA labeling instructions and criteria.

2. Absent specific medical record documentation of the reasons for more frequent application thereshould be no fewer than two (2) weeks between applications for venous stasis ulcers and there shouldbe no fewer than three (3) weeks between applications for neuropathic diabetic foot ulcers, except whenmore frequent applications are either a part of the FDA product specific labeling instructions or areclearly supported by medical record documentation of medically reasonable and necessary indications.

3. Treatment of any ulcer will typically last no more than twelve (12) weeks.

4. For venous stasis ulcers, two (2) applications of the skin substitute are indicated unless FDA productspecific labeling provides for additional applications. If after twelve (12) weeks of compressiontreatment and the appropriate number of applications of the skin substitutes a 50 percent or greaterimprovement is noted and documented, then one or more subsequent re-application of the skinsubstitute will be considered for Medicare coverage. Otherwise, re-application of the skin substitute isnot recommended and other treatment modalities should be considered.

5. Re-treatment within one (1) year of completion of any given course of skin substitutes for venousstasis ulcers is not covered.

6. For neuropathic diabetic foot ulcers, if after nine (9) weeks of treatment, and three (3) applications ofthe skin substitute, satisfactory healing progress is not noted, then re-application of the skin substitute isnot recommended and other treatment modalities should be considered.

7. Coverage will not be provided under this LCD for any wound treatment that does not meet thedefinition of Q4101 , Q4102, or Q4106. 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 deniedcoverage under this LCD. All such products will be considered to be - at most - “biologic wounddressings”.Dressings, by definition, are part of the relevant Evaluation & Management (E/M) service provided andnot separately payable: Q4100, Q4104, Q4105, Q4107, Q4107, Q4108, Q4109, Q4110, Q4111, Q4112,Q4113, Q4114, Q4115, Q4116, C9358, C9360, and C9363. Examples of such non-separatelyreimbursed "wound dressings" are Biovance TM (Biovance TM is described in its FDA-labeling as“wound covering”) and Integra TM. These and others are considered wound dressings, not skinsubstitutes, and are not separately payable by Medicare. Payment for these products is packaged intothe appropriate level of E/M service whether or not the E&M service is provided on the same or aprevious day.

(Providers are again reminded that the application of the dressings noted above is not separately paid,such as if billed with CPT codes 15170-15176).

8. Consistent with FDA product labeling, which limits the use of the bioengineered skin substitutes(Q4101, Q4102, Q4106) to clean wounds, thus requiring, at most, minimal debridement, CPT codes15002 through 15005 are not appropriate. The minimal wound preparation described by these codes ispart of the application procedure code, as clearly included in the procedure CPT preamble anddescription. To emphasize this point: The CPT Manual introductory comments to the “SkinReplacement Surgery and Skin Substitutes” chapter reconfirms this position in stating, “ Identify bysize… and the type of graft or skin substitute; includes simple debridement of granulation tissue orrecent avulsion.” (referring to the skin substitute application procedure codes) (Emphasis NAS')

When more substantial debridement is warranted, consider use of one of the debridement codes (11040-11042). In either instance, the medical record documentation must clearly support that anyamount of debridement was medically reasonable and necessary. Providers should note that, as theliterature clearly demonstrates that development of necrosis significant enough to require debridementas often as weekly strongly suggests that vascularity is insufficient to allow wound healing even withthe use of skin substitutes.

9. Providers are reminded that the use of otherwise payable codes must be consistent with Statelicensure and scope of practice limitations.

10. Providers are again reminded that this LCD neither addresses nor applies to coverage of any skinsubstitutes or related products in the treatment of burns described by ICD-9-CM codes 940.0 -949.5.That is, this LCD does not include criteria for the burn uses of these products.

The only reason the burn code treatments and range of burn diagnoses are mentioned in this policy isdue to the fact that HCPCS 2007 has included in its description of J7340 the direction, "Use this codefor Apligraf, Orcel (sic), TransCyte TM" It appears that currently the only labeled use of the TransCyteTM product is in burn wound treatment. Given that, as noted above, the primary thrust of this LCD istoward the use of skin substitute products in ulcers and given that we have not experienced significantmis-use of the TransCyte TM product or similar burn treatment products, NAS includes the use ofTransCyte TM and other similar burn treatments in this LCD only to the extent that we indicate coverageis available when medically reasonable and necessary in the treatment of burns and when usedconsistent with FDA labeling.

Once again, providers are reminded that requirements for use according to FDA labeling and formedical reasonableness and necessity apply. If circumstances in the future warrant LCD considerationof these products and their uses, NAS will consider establishing an LCD specific to them.

For Q4101 (Apligraf&reg)For any product appropriately billed under this code, the FDA labeling instructions must be followed in theirentirety, including criteria, frequency, and acceptable duration of treatment. The medical record must documentthat all labeling instructions have been followed.

NOTE: NAS recognizes that Q4101 may describe products that are medically necessary in and approved forthe treatment of burns. Burn therapy and associated treatment products are not the subject(s) of this policy.

For Q4102 (Oasis&reg):The FDA (and labeling) no longer refers to this product as a “wound dressing” in the product description. Inaddition, current clinical experience and literature indicate that this product may be of significant benefit in thecomprehensive treatment of ulcers as required by this policy. If this product is used in accordance with labelinginstructions and the indication justifies its use as medically reasonable and necessary, the product may becovered.

Furthermore, since Oasis® application is considered a physician service, it must be applied by either aphysician or a non-physician provider (NPP), and NOT by non-advance practice nurses, therapists or medicalassistants.Note: CPT codes 15430 and 15431 are to be used under the terms of this LCD only with HCPCS code Q4102.

For Q4106 (Dermagraf&reg)Assuming this product reenters or has reentered the marketplace, the product will be covered for the treatmentof full-thickness diabetic foot ulcers greater that six weeks duration which extend through the dermis, butwithout tendon, muscle, joint capsule or bone exposure. This product must be used in conjunction withstandard wound care regimens and in patients who have adequate blood supply to the involved foot.

NAS will cover a maximum of eight (8) applications of Q4106 for the treatment of any given lesion. Inaddition, the medical record must clearly document that conservative pre-treatment wound management hasbeen tried and failed to induce healing. Also, when used for billing of Dermagraft® the record must documentstrict adherence to the twenty-four (24) steps involved in the correct use of this product, as described in theclinical trials leading to FDA approval and included in the manufacturer's “Directions for Use”. The providermust take notice of these specific instructions for use. They will not be listed in this policy.

Critical Access Hospitals billing Method II should note, however, that the product has been valued according toa 90-day global period under the Physician Fee Schedule. Therefore, the application will be paid no morefrequently than at 90-day intervals for physicians. The facility may bill for application and product at afrequency appropriate to the clinical circumstances.

NOTE: CPT codes 15002, 15003, 15004, 15005, 15170, 15171, 15175, 15176, and HCPCS codes Q4100(skin sub NOC), Q4103, Q4104, Q4105, Q4107, Q4108, Q4109, Q4110, Q4111, Q4112, Q4113, Q4114,Q4115, Q4116, C9358, C9360, and C9363 are not separately payable. (See narrative above and code listsbelow.)

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to reportthis 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 policyshould be assumed to apply equally to all claims.

12x Hospital-inpatient or home health visits (Part B only)

13x Hospital-outpatient (HHA-A also) (under OPPS 13Xmust be used for ASC claims submitted for OPPSpayment -- eff. 7/00)

22x SNF-inpatient or home health visits (Part B only)

23x SNF-outpatient (HHA-A also)

85x Special facility or ASC surgery-rural primary carehospital (eff 10/94)

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used toreport this service. In most instances Revenue Codes are purely advisory; unless specified in the policyservices 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 andthe policy should be assumed to apply equally to all Revenue Codes.

045X Emergency room-general classification

049X Ambulatory surgical care-general classification

051X Clinic-general classification

052X Free-standing clinic-general classification

CPT/HCPCS Codes

The section titled “Does the 'CPT 30% Rule' apply?” needs clarification. This rule comes from the AMA(American Medical Association), the organization that holds the copyrights for all CPT codes. The rules statethat if, in a given section (e.g., surgery) or subsection (e.g., surgery, integumentary) of the CPT Manual,more than 30% of the codes are listed in the LCD, then the short descriptors must be used rather than the longdescriptors found in the CPT Manual.

NON-COVERED PRODUCTS: Not Separately Payable as bioengineered skin substitutes. Thefollowing products are considered to be wound dressings. See discussion in #7 in the “Limitations”section of “Indications and Limitations of Coverage and/or Medical Necessity” above):C9358 DERMAL SUBSTITUTE, NATIVE, NON-

DENATURED COLLAGEN, FETAL BOVINEORIGIN (SURGIMEND COLLAGEN MATRIX),PER 0.5 SQUARE CENTIMETERS

C9360 DERMAL SUBSTITUTE, NATIVE, NON-DENATURED COLLAGEN, NEONATALBOVINE ORIGIN (SURGIMEND COLLAGENMATRIX), PER 0.5 SQUARE CENTIMETERS

C9363 SKIN SUBSTITUTE, INTEGRA MESHEDBILAYER WOUND MATRIX, PER SQUARECENTIMETER

Q4100 SKIN SUBSTITUTE, NOT OTHERWISESPECIFIED

Q4103 SKIN SUBSTITUTE, OASIS BURN MATRIX,PER SQUARE CENTIMETER

Q4104 SKIN SUBSTITUTE, INTEGRA BILAYERMATRIX WOUND DRESSING (BMWD), PERSQUARE CENTIMETER

Q4105 SKIN SUBSTITUTE, INTEGRA DERMALREGENERATION TEMPLATE (DRT), PERSQUARE CENTIMETER

Q4107 SKIN SUBSTITUTE, GRAFTJACKET, PERSQUARE CENTIMETER

Q4108 SKIN SUBSTITUTE, INTEGRA MATRIX, PERSQUARE CENTIMETER

Q4109 SKIN SUBSTITUTE, TISSUEMEND, PERSQUARE CENTIMETER

Q4110 SKIN SUBSTITUTE, PRIMATRIX, PER SQUARECENTIMETER

Q4111 SKIN SUBSTITUTE, GAMMAGRAFT, PERSQUARE CENTIMETER

Q4112 ALLOGRAFT, CYMETRA, INJECTABLE, 1CC

Q4113 ALLOGRAFT, GRAFTJACKET EXPRESS,INJECTABLE, 1CC

Q4114 INTEGRA FLOWABLE WOUND MATRIX,INJECTABLE, 1CC

Q4115 SKIN SUBSTITUTE, ALLOSKIN, PER SQUARECENTIMETER

Q4116 SKIN SUBSTITUTE, ALLODERM, PER SQUARECENTIMETER

NON-COVERED PROCEDURES: Those procedures which are either not separately payable under theterms of this LCD on lower extremity ulcers or not appropriately used with the covered bioengineered skinsubstitutes which are described by Q4101 , Q4102, or Q4106.15002 SURGICAL PREPARATION OR CREATION OF

RECIPIENT SITE BY EXCISION OF OPENWOUNDS, BURN ESCHAR, OR SCAR(INCLUDING SUBCUTANEOUS TISSUES), ORINCISIONAL RELEASE OF SCARCONTRACTURE, TRUNK, ARMS, LEGS; FIRST100 SQ CM OR 1% OF BODY AREA OFINFANTS AND CHILDREN

15003 SURGICAL PREPARATION OR CREATION OFRECIPIENT SITE BY EXCISION OF OPENWOUNDS, BURN ESCHAR, OR SCAR(INCLUDING SUBCUTANEOUS TISSUES), ORINCISIONAL RELEASE OF SCARCONTRACTURE, TRUNK, ARMS, LEGS; EACHADDITIONAL 100 SQ CM, OR PART THEREOF,OR EACH ADDITIONAL 1% OF BODY AREAOF INFANTS AND CHILDREN (LISTSEPARATELY IN ADDITION TO CODE FORPRIMARY PROCEDURE)

15004 SURGICAL PREPARATION OR CREATION OFRECIPIENT SITE BY EXCISION OF OPENWOUNDS, BURN ESCHAR, OR SCAR(INCLUDING SUBCUTANEOUS TISSUES), ORINCISIONAL RELEASE OF SCARCONTRACTURE, FACE, SCALP, EYELIDS,MOUTH, NECK, EARS, ORBITS, GENITALIA,HANDS, FEET AND/OR MULTIPLE DIGITS;FIRST 100 SQ CM OR 1% OF BODY AREA OFINFANTS AND CHILDREN

15005

SURGICAL PREPARATION OR CREATION OFRECIPIENT SITE BY EXCISION OF OPENWOUNDS, BURN ESCHAR, OR SCAR(INCLUDING SUBCUTANEOUS TISSUES), ORINCISIONAL RELEASE OF SCARCONTRACTURE, FACE, SCALP, EYELIDS,MOUTH, NECK, EARS, ORBITS, GENITALIA,HANDS, FEET AND/OR MULTIPLE DIGITS;EACH ADDITIONAL 100 SQ CM, OR PARTTHEREOF, OR EACH ADDITIONAL 1% OFBODY AREA OF INFANTS AND CHILDREN(LIST SEPARATELY IN ADDITION TO CODEFOR PRIMARY PROCEDURE)

15170 ACELLULAR DERMAL REPLACEMENT,TRUNK, ARMS, LEGS; FIRST 100 SQ CM ORLESS, OR 1% OF BODY AREA OF INFANTSAND CHILDREN

15171 ACELLULAR DERMAL REPLACEMENT,TRUNK, ARMS, LEGS; EACH ADDITIONAL 100SQ CM, OR EACH ADDITIONAL 1% OF BODYAREA OF INFANTS AND CHILDREN, OR PARTTHEREOF (LIST SEPARATELY IN ADDITIONTO CODE FOR PRIMARY PROCEDURE)

15175 ACELLULAR DERMAL REPLACEMENT, FACE,SCALP, EYELIDS, MOUTH, NECK, EARS,ORBITS, GENITALIA, HANDS, FEET, AND/ORMULTIPLE DIGITS; FIRST 100 SQ CM OR LESS,OR 1% OF BODY AREA OF INFANTS ANDCHILDREN

15176 ACELLULAR DERMAL REPLACEMENT, FACE,SCALP, EYELIDS, MOUTH, NECK, EARS,ORBITS, GENITALIA, HANDS, FEET, AND/ORMULTIPLE DIGITS; EACH ADDITIONAL 100SQ CM, OR EACH ADDITIONAL 1% OF BODYAREA OF INFANTS AND CHILDREN, OR PARTTHEREOF (LIST SEPARATELY IN ADDITIONTO CODE FOR PRIMARY PROCEDURE)

COVERED PRODUCTS

Q4101 SKIN SUBSTITUTE, APLIGRAF, PER SQUARECENTIMETER

Q4102 SKIN SUBSTITUTE, OASIS WOUND MATRIX,PER SQUARE CENTIMETER

Q4106 SKIN SUBSTITUTE, DERMAGRAFT, PERSQUARE CENTIMETER

COVERED APPLICATION PROCEDURES

Note: Correct claims’ coding requires THREE (or four) codes. For the products designated by HCPCS codesQ4101 and Q4106, use one of the application codes in the list below (15340, 15341, 15360, 15361, 153465,15366) and the appropriate ICD-9-CM code(s) listed below.

15340 TISSUE CULTURED ALLOGENEIC SKINSUBSTITUTE; FIRST 25 SQ CM OR LESS

15341 TISSUE CULTURED ALLOGENEIC SKINSUBSTITUTE; EACH ADDITIONAL 25 SQ CM,OR PART THEREOF (LIST SEPARATELY INADDITION TO CODE FOR PRIMARYPROCEDURE)

15360 TISSUE CULTURED ALLOGENEIC DERMALSUBSTITUTE, TRUNK, ARMS, LEGS; FIRST 100SQ CM OR LESS, OR 1% OF BODY AREA OFINFANTS AND CHILDREN

15361 TISSUE CULTURED ALLOGENEIC DERMALSUBSTITUTE, TRUNK, ARMS, LEGS; EACHADDITIONAL 100 SQ CM, OR EACHADDITIONAL 1% OF BODY AREA OF INFANTSAND CHILDREN, OR PART THEREOF (LISTSEPARATELY IN ADDITION TO CODE FORPRIMARY PROCEDURE)

15365 TISSUE CULTURED ALLOGENEIC DERMALSUBSTITUTE, FACE, SCALP, EYELIDS,MOUTH, NECK, EARS, ORBITS, GENITALIA,HANDS, FEET, AND/OR MULTIPLE DIGITS;FIRST 100 SQ CM OR LESS, OR 1% OF BODYAREA OF INFANTS AND CHILDREN

15366 TISSUE CULTURED ALLOGENEIC DERMALSUBSTITUTE, FACE, SCALP, EYELIDS,MOUTH, NECK, EARS, ORBITS, GENITALIA,HANDS, FEET, AND/OR MULTIPLE DIGITS;EACH ADDITIONAL 100 SQ CM, OR EACHADDITIONAL 1% OF BODY AREA OF INFANTSAND CHILDREN, OR PART THEREOF (LISTSEPARATELY IN ADDITION TO CODE FORPRIMARY PROCEDURE)

COVERED APPLICATION PROCEDURES

Note: Correct claims’ coding requires THREE (or four) codes (product code, application code and one or twodiagnoses codes). For the product designated by HCPCS codes Q4102, use one of the application codes in thelist below (15430 or 15431) only and the appropriate ICD-9-CM code(s) listed below.

15430 ACELLULAR XENOGRAFT IMPLANT; FIRST100 SQ CM OR LESS, OR 1% OF BODY AREAOF INFANTS AND CHILDREN

15431 ACELLULAR XENOGRAFT IMPLANT; EACHADDITIONAL 100 SQ CM, OR EACHADDITIONAL 1% OF BODY AREA OF INFANTSAND CHILDREN, OR PART THEREOF (LISTSEPARATELY IN ADDITION TO CODE FORPRIMARY PROCEDURE)

ICD-9 Codes that Support Medical Necessity

GROUP 1Note: Diagnosis codes are based on the current ICD-9-CM codes that are effective at the time of LCDpublication. Any updates to ICD-9-CM codes will be reviewed by NAS, and coverage should not bepresumed until the results of such review have been published/posted.

These are the only ICD-9-CM codes that support medical necessity:

Note: For the products covered by this LCD, use the appropriate ICD-9-CM code(s) that applies to both theappropriate product (designated by Q4101, Q4102, Q4106) and the CPT application code (15340, 15341,15360, 15361, 15365, 15366, 15430, 15431).

Note: Diagnosis criteria do not apply to the following CPT/HCPCS codes: 15002, 15003, 15004, 15005,15170, 15171, 15175, 15176, Q4100, Q4103, Q4104, Q4105, Q4107, Q4108, Q4109, Q4110, Q4111, Q4112,Q4113, Q4114, Q4115, Q4116, C9358, C9360, and C9363. These codes are either not separately payableunder the terms of this LCD on Lower Extremity Ulcers or not applicable to the LCD (inappropriate for usewith the covered skin substitute products). Burn care is neither considered nor covered by and under the termsof this LCD on Lower Extremity Ulcers.

For 15340, 15341, 15360, 15361, 15365, 15366, 15430, and 15431:The following ICD-9-CM codes may be used alone:454.0 VARICOSE VEINS OF LOWER EXTREMITIES

WITH ULCER

454.2 VARICOSE VEINS OF LOWER EXTREMITIESWITH ULCER AND INFLAMMATION

757.39* OTHER SPECIFIED CONGENITAL ANOMALIESOF SKIN

*ICD-9-CM code 757.39 may be used only for epidermolysis bullosa

GROUP 2AFor 15340, 15341, 15360, 15361, 15365, 15366, 15430, and 15431:

The following ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondarydiagnosis.

Primary diagnoses:707.10* UNSPECIFIED ULCER OF LOWER LIMB

707.11* ULCER OF THIGH

707.12* ULCER OF CALF

707.13* ULCER OF ANKLE

707.14* ULCER OF HEEL AND MIDFOOT

707.15* ULCER OF OTHER PART OF FOOT

707.19* ULCER OF OTHER PART OF LOWER LIMB

*Consistent with FDA labeling under the terms of this LCD, NAS’ intent is to limit the use of thisproduct to lower limb ulcers caused by varicose veins or diabetes. When billing for ulcers caused bydiabetes or using the non-specific venous insufficiency code, 459.81, the provider must use both a codefrom the diabetes range (249.00–250.83) or 459.81, and a code from the lower limb ulcer code range(707.10–707.19).

GROUP 2BFor 15340, 15341, 15360, 15361, 15365, 15366, 15430, and 15431:Secondary diagnoses:

249.00* SECONDARY DIABETES MELLITUS WITHOUTMENTION OF COMPLICATION, NOT STATED ASUNCONTROLLED, OR UNSPECIFIED

249.01* SECONDARY DIABETES MELLITUS WITHOUTMENTION OF COMPLICATION, UNCONTROLLED

249.10* SECONDARY DIABETES MELLITUS WITHKETOACIDOSIS, NOT STATED ASUNCONTROLLED, OR UNSPECIFIED

249.11* SECONDARY DIABETES MELLITUS WITHKETOACIDOSIS, UNCONTROLLED

249.20* SECONDARY DIABETES MELLITUS WITHHYPEROSMOLARITY, NOT STATED ASUNCONTROLLED, OR UNSPECIFIED

249.21* SECONDARY DIABETES MELLITUS WITHHYPEROSMOLARITY, UNCONTROLLED

249.30* SECONDARY DIABETES MELLITUS WITH OTHERCOMA, NOT STATED AS UNCONTROLLED, ORUNSPECIFIED

249.31* SECONDARY DIABETES MELLITUS WITH OTHERCOMA, UNCONTROLLED

249.40* SECONDARY DIABETES MELLITUS WITH RENALMANIFESTATIONS, NOT STATED ASUNCONTROLLED, OR UNSPECIFIED

249.41* SECONDARY DIABETES MELLITUS WITH RENALMANIFESTATIONS, UNCONTROLLED

249.50* SECONDARY DIABETES MELLITUS WITHOPHTHALMIC MANIFESTATIONS, NOT STATEDAS UNCONTROLLED, OR UNSPECIFIED

249.51* SECONDARY DIABETES MELLITUS WITHOPHTHALMIC MANIFESTATIONS,UNCONTROLLED

249.60* SECONDARY DIABETES MELLITUS WITHNEUROLOGICAL MANIFESTATIONS, NOTSTATED AS UNCONTROLLED, OR UNSPECIFIED

249.61* SECONDARY DIABETES MELLITUS WITHNEUROLOGICAL MANIFESTATIONS,UNCONTROLLED

249.70*

SECONDARY DIABETES MELLITUS WITHPERIPHERAL CIRCULATORY DISORDERS, NOTSTATED AS UNCONTROLLED, OR UNSPECIFIED

249.71* SECONDARY DIABETES MELLITUS WITHPERIPHERAL CIRCULATORY DISORDERS,UNCONTROLLED

249.80* SECONDARY DIABETES MELLITUS WITH OTHERSPECIFIED MANIFESTATIONS, NOT STATED ASUNCONTROLLED, OR UNSPECIFIED

249.81* SECONDARY DIABETES MELLITUS WITH OTHERSPECIFIED MANIFESTATIONS, UNCONTROLLED

249.90* SECONDARY DIABETES MELLITUS WITHUNSPECIFIED COMPLICATION, NOT STATED ASUNCONTROLLED, OR UNSPECIFIED

249.91* SECONDARY DIABETES MELLITUS WITHUNSPECIFIED COMPLICATION, UNCONTROLLED

250.60* DIABETES WITH NEUROLOGICALMANIFESTATIONS, TYPE II OR UNSPECIFIEDTYPE, NOT STATED AS UNCONTROLLED

250.61* DIABETES WITH NEUROLOGICALMANIFESTATIONS, TYPE I [JUVENILE TYPE],NOT STATED AS UNCONTROLLED

250.62* DIABETES WITH NEUROLOGICALMANIFESTATIONS, TYPE II OR UNSPECIFIEDTYPE, UNCONTROLLED

250.63* DIABETES WITH NEUROLOGICALMANIFESTATIONS, TYPE I [JUVENILE TYPE],UNCONTROLLED

250.70* DIABETES WITH PERIPHERAL CIRCULATORYDISORDERS, TYPE II OR UNSPECIFIED TYPE,NOT STATED AS UNCONTROLLED

250.71* DIABETES WITH PERIPHERAL CIRCULATORYDISORDERS, TYPE I [JUVENILE TYPE], NOTSTATED AS UNCONTROLLED

250.72* DIABETES WITH PERIPHERAL CIRCULATORYDISORDERS, TYPE II OR UNSPECIFIED TYPE,UNCONTROLLED

250.73* DIABETES WITH PERIPHERAL CIRCULATORYDISORDERS, TYPE I [JUVENILE TYPE],UNCONTROLLED

250.80* DIABETES WITH OTHER SPECIFIEDMANIFESTATIONS, TYPE II OR UNSPECIFIEDTYPE, NOT STATED AS UNCONTROLLED

250.81* DIABETES WITH OTHER SPECIFIEDMANIFESTATIONS, TYPE I [JUVENILE TYPE],NOT STATED AS UNCONTROLLED

250.82*

DIABETES WITH OTHER SPECIFIEDMANIFESTATIONS, TYPE II OR UNSPECIFIEDTYPE, UNCONTROLLED

250.83* DIABETES WITH OTHER SPECIFIEDMANIFESTATIONS, TYPE I [JUVENILE TYPE],UNCONTROLLED

459.81* VENOUS (PERIPHERAL) INSUFFICIENCYUNSPECIFIED


GROUP 3For Q4101, Q4102:

The following ICD-9-CM codes may be used alone:454.0 VARICOSE VEINS OF LOWER EXTREMITIES

WITH ULCER

454.2 VARICOSE VEINS OF LOWER EXTREMITIESWITH ULCER AND INFLAMMATION

940.0 - 949.5* CHEMICAL BURN OF EYELIDS ANDPERIOCULAR AREA - DEEP NECROSIS OFUNDERLYING TISSUES DUE TO BURN (DEEPTHIRD DEGREE UNSPECIFIED SITE WITHLOSS OF A BODY PART

*940.0-949.5 to be used only for TransCyteTM , OrCelTM and other similar products when used inburn treatment when such use is medically reasonable and necessary and consistent with FDAlabeling. For information only; not part of this policy.

GROUP 4AFor Q4101, Q4102:


Primary diagnoses:

707.10* UNSPECIFIED ULCER OF LOWER LIMB








GROUP 4BFor Q4101, Q4102:

Secondary diagnoses:















249.70* SECONDARY DIABETES MELLITUS WITHPERIPHERAL CIRCULATORY DISORDERS, NOTSTATED AS UNCONTROLLED, OR UNSPECIFIED
















250.82*

DIABETES WITH OTHER SPECIFIEDMANIFESTATIONS, TYPE II OR UNSPECIFIEDTYPE, UNCONTROLLED


459.81* VENOUS (PERIPHERAL) INSUFFICIENCYUNSPECIFIED


GROUP 5For Q4106:The following ICD-9-CM code may be used alone:

757.39* OTHER SPECIFIED CONGENITAL ANOMALIESOF SKIN

*ICD-9-CM code 757.39 may be used only for epidermolysis bullosa

GROUP 6AFor Q4106:


Primary diagnoses:

707.10* UNSPECIFIED ULCER OF LOWER LIMB







*Consistent with FDA labeling under the terms of this LCD, NAS’ intent is to limit the use of thisproduct to lower limb ulcers caused by varicose veins or diabetes. When billing for ulcers caused bydiabetes, the provider must use both a code from the diabetes range (249.00–250.83) and a code fromthe lower limb ulcer code range (707.10–707.19).

GROUP 6BFor Q4106:

Secondary diagnoses:















249.70* SECONDARY DIABETES MELLITUS WITHPERIPHERAL CIRCULATORY DISORDERS, NOTSTATED AS UNCONTROLLED, OR UNSPECIFIED
















250.82* DIABETES WITH OTHER SPECIFIEDMANIFESTATIONS, TYPE II OR UNSPECIFIEDTYPE, UNCONTROLLED


*Consistent with FDA labeling under the terms of this LCD, NAS’ intent is to limit the use of thisproduct to lower limb ulcers caused by varicose veins or diabetes. When billing for ulcers caused bydiabetes, the provider must use both a code from the diabetes range (249.00–250.83) and a code fromthe lower limb ulcer code range (707.10–707.19).

Diagnoses that Support Medical Necessity

All, ICD-9-CM codes listed under “ICD-9-CM Codes that Support Medical Necessity” above.

ICD-9 Codes that DO NOT Support Medical Necessity

All ICD-9-CM codes not listed under “ICD-9-CM Codes that Support Medical Necessity” above.

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

Diagnoses that DO NOT Support Medical Necessity

All ICD-9-CM codes not listed under ICD-9-CM Codes that “Support Medical Necessity” above, including butnot limited to the following:

1. Infected ulcer2. Osteomyelitis3. Allergy to bovine collagen4. Neuropathic diabetic foot ulcers without pedal pulses5. Uncontrolled diabetes (“controlled” diabetes for purposes of this policy would be based on documentation inthe medical record)6. Active Charcot arthropathy of the ulcer extremity7. Vasculitis8. Uncontrolled rheumatoid arthritis and/or rheumatoid ulcers9. Other uncontrolled collagen vascular disease10. Patients being treated with high dose corticosteroids or immunosuppressants11. Patients who have undergone radiation and/or chemotherapy within the month immediately precedingproposed skin substitute treatment.

General Information

Documentation Requirements

The medical record must clearly show that the criteria listed in “Indications and Limitation of Coverage and/orMedical Necessity” have been met. The ulcer must be measured at the beginning of conservative treatment,following cessation of conservative treatment and at the beginning of the skin substitute treatment. Clearly, ifduring treatment the ulcer shows obvious signs of worsening or lack of treatment response, continuing skinsubstitute treatment would be inappropriate absent documentation of an appropriate rationale for doing so.

The literature demonstrates that survival of Q4106 decreases significantly when the 24 steps noted in the FDAlabeling are not followed. The documentation must show that these steps were followed.

NAS will cover a maximum of 8 applications of Q4106 for the treatment of any given lesion. In addition, themedical record must clearly document that conservative pre-treatment wound management has been tried andfailed to induce healing. For Dermagraft® (Q4106), the record must document that the twenty-four (24) stepsinvolved in the correct use of this product, as described in the clinical trials leading to FDA approval andincluded in the manufacturer's “Directions for Use”, as of the date of development of this LCD have beenfollowed. This requirement is based on the demonstrated decrement in survival of the dermal substitute whenthe 24 steps noted in the FDA labeling are not followed. The provider must take notice of these specificinstructions for use. They will not be listed in this policy.

The medical record must document that wound treatment is accompanied by appropriate wound dressingduring the healing period and by appropriate compressive therapy for foot ulcer(s) and appropriate steps to off-load wound pressure during follow-up. Adequate patient compliance must be clearly ascertained anddocumented during such treatment.

In most instances, consistent with FDA product labeling and current CPT language included in the introductoryinformation on the family of Skin Substitute codes that limits the use of these products to clean wounds, CPTcode 15002-15005 are not appropriate. Standard, routine minimal wound preparation is considered a part of theprocedure. In any instance of utilization of a separate debridement code, there is a high likelihood of Contractorrecord review; therefore the medical record documentation must clearly support that any amount of separately-billed debridement was substantial and was medically reasonable and necessary. Providers are reminded thatFDA-labeling should be reviewed in order to determine that the skin substitute itself is even indicated insuch cases of significant same-day debridement.

The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not takeprecedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable codecombinations prior to billing Medicare.

When, the documentation does not meet the criteria for the service rendered or the documentation does notestablish the medical necessity for the services, such services will be denied as not reasonable and necessaryunder Section 1862(a)(1) of the Social Security Act.

Appendices

Utilization Guidelines

1. For venous stasis ulcers, treatment will normally last approximately twelve (12) weeks. If after twelve weeksof compression treatment, and two (2) applications of the skin substitute, satisfactory healing progress is notnoted then reapplication of the skin substitute is not recommended and other treatment modalities should beconsidered.

2. For neuropathic diabetic foot ulcers, treatment will normally last approximately twelve (12) weeks. If afternine (9) weeks of treatment, and three (3) applications of the skin substitute, satisfactory healing progress is notnoted, then reapplication of the skin substitute is not recommended and other treatment modalities should beconsidered.

3. No re-treatment would be expected within the first year following successful initial treatment.

4. “Graft” Definition

Noridian is aware that some controversy has arisen among the provider and manufacturing communityconcerning the applicability of the term “graft” in the use, coding, billing of and payment for skin substitutesand their application. We also are aware that some of these skin substitute products (or “devices”) may be usedas true substitutes for skin, whereas other uses could more accurately be termed “scaffolding,” “ingrowth-facilitating” (“matrix”), or even simply “wound dressing.”

Noridian recognizes that there is no specific CMS or CPT definition of the term “graft.” Dorland’s IllustratedMedical Dictionary, 31st Edition (2007), defines “graft,” as“1. any tissue or organ for implantation or transplantation; and“skin graft” as “skin transplanted to replace a lost portion of the body skin surface; it may be a full-thickness orsplit-thickness graft.”

Taber’s Cyclopedic Medical Dictionary, 20th Edition (2005) defines “graft” as“1. Tissue transplanted or implanted in a part of the body to repair a defect….”; and“skin graft” as: “The use of small sections of skin harvested from a donor site to repair a defect or trauma of theskin,…”

These definitions partially assist in the determination of which products may be considered skin substitutes.Nonetheless, neither of the definitions is ultimately helpful in determining when the products are payable asskin substitutes since the primary distinction for Medicare coverage is whether the material (or device) is beingused as a true “substitute,” as opposed to a tissue-ingrowth matrix, scaffolding or dressing.

The definition of skin graft and, consequently, determination of what products may function as skin substituteshas obvious impact, not only on the decision of coverage, but also on that of frequency of re-application,assuming the initial decision allowed payment. Noridian therefore has established the following language as apayment guideline.

For coverage of skin substitute products (devices) subject to Noridian’s Application of Skin Substitutes LCD, aproduct will be considered as a graft if the product is intended:1) at the time of application to fully replace lost tissue, and

2) to achieve closure of a wound (whether in fact it is successful is not a firm criterion upon which paymentwould be based)

The expectation is that the product itself will function as a permanent replacement for the lost ordamaged skin.

On the other hand, if the product is intended to achieve temporary closure or coverage of the wound, or to actas a matrix or scaffolding that encourages and/or otherwise supports the ingrowth of the patient’s own tissuesin order to achieve permanent wound closure, we will not consider that use as a “graft.” Application ofproducts, which warrant routine and/or anticipated replacement would be - at best - wound dressings, not“grafts.”

Sources of Information and Basis for Decision

FDA Approval Notice, dated May 22, 1998

FDA Approval Notice for neuropathic diabetic foot ulcers Decision dated June 20, 2000

CMD Surgery/Surgery New Technology Workgroup

Consultants from PM&R, Podiatry, Vascular Surgery, Orthopedic Surgery, Plastic Surgery

"Diabetic Foot Disorders, A Clinical Practice Guideline (2006 revision), "Journal of Foot and Ankle Surgerysupplement 2, vol.45, No.5, Sept/Oct 2006.

Falanga, V., & Sabolinski, M., “A bilayered living skin construct (Apligraf®) accelerates complete closure ofhard-to-heal venous ulcers,” Wound Repair and Regeneration, vol. 7, No. 4, July-August 1999.

Prescribing Information: Apligraf® (graftskin), Organogenesis Inc.

Olin, J.W., Beusterien, K.M., Childs, M. B., Seavy, C., Griffiths, R.I., “Medical costs of treating venous stasisulcers: evidence from a retrospective cohort study,” Vascular Medicine, volume 4, pp. 1-7,1999.

Muhart,et al., "Behavior of Tissue Engineered Skin, A Comparison of a Living Skin Equivalent, Autograft, andOcclusive Dressing in Human Donor Sites", Archives of Dermatology, August 1999 (Reprint).

Snyder, et al., "Cadaveric Allograft as Adjunct Therapy for Nonhealing Ulcers, Journal of Foot and AnkleSurgery", March/April, 1999(Abstract).

Falanga, et al., "Rapid Healing of Venous Ulcers and Lack of Clinical Rejection with an Allogenic CulturedHuman Skin Equivalent", Archives of Dermatology, March, 1998 (Abstract).

Revision of the CEAP classification for chronic venous disorders; Consensus statement; Journal of VascularSurgery, Volume 40, Issue 6, Pages 1248-1252 B. Eklof, R. Rutherford, J. Bergan, P. Carpentier, P. Gloviczki,R. Kistner, M. Meissner, G. Moneta, K. Myers, F. Padberg

Other Medicare Contractors' policies

NAS Open Door Coverage Meetings and groups

NAS Carrier Advisory Committee members

Advisory Committee Meeting Notes

This policy does not reflect the sole opinion of the contractor or contractor medical director(s). Although thefinal decision rests with the contractor, this policy was developed in cooperation with representatives fromvarious medical societies.

This medical policy consolidates and replaces all previous policies and publications on this subject byNoridian Administrative Services (NAS) and its predecessors for Medicare Part A.

NAS’ Responses to Provider Recommendations:

1. Numerous comments were received urging coverage for Oasis. As noted earlier in this LCD, we reviewedthe change in FDA product labeling, manufacturer’s instructions, and the substantial amount of literature thathas emerged in review of the use of this product.

NAS has accepted that advice, hence the addition of the Oasis™ coverage statements.

2. Several comments suggested that NAS more closely monitor the use of the skin substitute products,especially in terms of their incorporation into an organized and clearly defined program of wound management.

NAS has added language and guidance to this effect and reminds providers that close post pay reviewwill be directed to this area.

3. Literature and several commenters recommended that the policy specifically limit application of the coveredproducts to Physicians or NPPs (Non-Physician Providers).

NAS strongly agrees and has added appropriate language to effect that clarification.

4. One manufacturer and several consultants urged NAS to loosen requirements for documentation of aspecified length of time of conservative management of wounds as well as the limits on number of allowableapplications of the various products.

NAS rejects these changes, and has determined that we will continue to require adherence to FDAlabeling and will contemplate changes in these requirements only if and after FDA labeling has beenchanged accordingly.

5. Some commenters wanted to know if Biovance and Integra would be separately reimbursed.

NAS welcomes requests for reconsideration of its current policy when a specific HCPCS code is assignedto these products and as literature concerning their use sufficiently matures.

6. Several commenters urged the non-inclusion of burn products and procedures in this policy.

This policy does not address the treatment of burns. The reason the burn code treatments are mentioned inthis policy is due to the fact that HCPCS 2007 has included in its description of J7340 the direction, "Use thiscode for Apligraf, Orcel (sic), TransCyte™." It appears that currently the only labeled use of the TransCyte™

product is in burn wound treatment. Given that, as noted above, the primary thrust of this LCD is toward theuse of skin substitute products in ulcers and given that we have not experienced significant mis-use of theTransCyte™ product or similar burn treatment products, NAS includes the use of TransCyte™ and other similarburn treatments in this LCD only to the extent that we indicate coverage is available when medicallyreasonable and necessary in the treatment of burns and when used consistent with FDA labeling. This LCDdoes not cover any other aspect of these burn treatment products, nor are any other criteria for the burn uses ofthese products subject to this policy. Once again, providers are reminded that requirements for use according toFDA labeling and for medical reasonableness and necessity apply. If circumstances in the future warrant LCDconsideration of these products and their uses, NAS will consider establishing an LCD specific to them.

Start Date of Comment Period

09/15/2005

End Date of Comment Period

10/31/2005

Start Date of Notice Period

11/15/2005

Revision History Number

R11

Revision History Explanation

Revision 3: No comments were received for this draft policy. The notice effective date of 11/15/2005 wasadded to the section "Start Date of Notice Period". The active final effective date of 12/31/2005 was also addedto the sections "Projected Determination Effective Date" and the "Revision Effective Date".

11/26/2005 - The description for CPT/HCPCS code J7340 was changed in group 111/26/2005 - The description for CPT/HCPCS code J7342 was changed in group 1

11/26/2005 - CPT/HCPCS code 15342 was deleted from group 111/26/2005 - CPT/HCPCS code 15343 was deleted from group 1

03/16/2006 - Updated for 2006 CPT Code Updates

7/2/2006 - The description for Revenue code 0521 was changed7/2/2006 - The description for Revenue code 0522 was changed

7/2/2006 - Revenue code 0524 was added to the code range 0520 - 05297/2/2006 - Revenue code 0525 was added to the code range 0520 - 05297/2/2006 - Revenue code 0527 was added to the code range 0520 - 05297/2/2006 - Revenue code 0528 was added to the code range 0520 - 0529

11/18/2006 - The description for CPT/HCPCS code 15360 was changed in group 111/18/2006 - The description for CPT/HCPCS code 15361 was changed in group 111/18/2006 - The description for CPT/HCPCS code 15365 was changed in group 111/18/2006 - The description for CPT/HCPCS code 15366 was changed in group 111/18/2006 - The description for CPT/HCPCS code 15170 was changed in group 211/18/2006 - The description for CPT/HCPCS code 15171 was changed in group 211/18/2006 - The description for CPT/HCPCS code 15175 was changed in group 211/18/2006 - The description for CPT/HCPCS code 15176 was changed in group 2

11/18/2006 - CPT/HCPCS code J7350 was deleted from group 2

02/16/2007-Added SD with the LCD effective date of 03/01/2007. There were no changes to the LCD for AZ,MT, ND, UT and WY.

This was a ND policy. This policy was implemented on the basis of claims errors and analysis of providerqueries, indicating the need for education.

R2) 04/25/2007 - Updated language in 'Indications and Limitations of Coverage and/or Medical Necessity'.Updated CPT/HCPCS Codes. Updated ICD-9 Codes. Updated language in 'Documentation Requirements'.Updated 'Sources of Information and Basis for Decision'. Added to Advisory Committee Meeting Notes.

R3) 09/07/2007 - In order to allow reimbursement for the application of the Oasis product (J7341) NAS hasadded the following two CPT codes 15430 and 15431 to this LCD. These are the only two codes to bill for theapplication of the Oasis product in accordance to the requirements of this LCD.

R4 Corrected the non-payable CPT code list. Clarified CPT codes 15430 and 15431.

11/10/2007 - CPT/HCPCS code J7345 was deleted from group 1

A2005.14 R5Based on 2008 CPT/HCPCS updates, HCPCS codes J7347, J7348, J7349 have been added to the policy.However, these codes are not covered under the terms of this LCD and will be denied as included in otherservices. They are listed for information only. In addition, some clarifying information was included in theLCD.

R6 Annual LCD review has been completed.LCD has been reviewed and updated with the following 2008-2009 ICD-9 CM diagnoses codes.

New ICD-9 CM codes applicable to this LCD:

For 15340, 15341, 15360, 15361, 15365, 15366, 15430, 15431, J7340, J7341 & J7342:The following ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis.

For 15340, 15341, 15360, 15361, 15365, 15366, 15430 and 15431:Secondary diagnoses: 249.00*, 249.01*, 249.10*, 249.11*, 249.20*, 249.21*, 249.30*, 249.31*, 249.40*,249.41*, 249.50*, 249.51*, 249.60*, 249.61*, 249.70*, 249.71*, 249.80*, 249.81*, 249.90* & 249.91*.

For J7340, J7341:The following ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis.

Secondary diagnoses: 249.00*, 249.01*, 249.10*, 249.11*, 249.20*, 249.21*, 249.30*, 249.31*, 249.40*,249.41*, 249.50*, 249.51*, 249.60*, 249.61*, 249.70*, 249.71*, 249.80*, 249.81*, 249.90* & 249.91*.

For J7342:The following ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis.

For J7342:Secondary diagnoses: 249.00*, 249.01*, 249.10*, 249.11*, 249.20*, 249.21*, 249.30*, 249.31*, 249.40*,249.41*, 249.50*, 249.51*, 249.60*, 249.61*, 249.70*, 249.71*, 249.80*, 249.81*, 249.90* & 249.91*.

11/09/2008 - The description for CPT/HCPCS code 15002 was changed in group 111/09/2008 - The description for CPT/HCPCS code 15003 was changed in group 111/09/2008 - The description for CPT/HCPCS code 15004 was changed in group 111/09/2008 - The description for CPT/HCPCS code 15005 was changed in group 111/09/2008 - The description for CPT/HCPCS code 15341 was changed in group 2

11/09/2008 - CPT/HCPCS code J7343 was deleted from group 111/09/2008 - CPT/HCPCS code J7344 was deleted from group 111/09/2008 - CPT/HCPCS code J7346 was deleted from group 111/09/2008 - CPT/HCPCS code J7347 was deleted from group 111/09/2008 - CPT/HCPCS code J7348 was deleted from group 111/09/2008 - CPT/HCPCS code J7349 was deleted from group 111/09/2008 - CPT/HCPCS code J7340 was deleted from group 211/09/2008 - CPT/HCPCS code J7341 was deleted from group 211/09/2008 - CPT/HCPCS code J7342 was deleted from group 2

A2005.14 R7NAS updated the narrative with the new "Q" codes & "C" codes

A2005.14 R8Added "The expectation is that the product itself will function as a permanent replacement for the lost ordamaged skin. See Utilization Guidelines." under Indications.

Added "Graft" definition to section "Utilization Guidelines".

A2005.14 R9

Clarification language added to: "Note: Correct claims’ coding requires THREE (or four) codes (product code,application code and one or two diagnosis codes.) For the products designated by HCPCS codes Q4101 andQ4106, use one of the application codes in the list below (15340, 15341, 15360, 15361, 153465, 15366) andthe appropriate ICD-9-CM code(s) listed below."

Clarification language added to: "Note: Correct claims’ coding requires THREE (or four) codes (product code,application code and one or two diagnoses codes). For the product designated by HCPCS codes Q4102, useone of the application codes in the list below (15430 or 15431) only and the appropriate ICD-9-CM code(s)listed below."

757.39* was added to Group I.

06/21/2009 - The description for CPT/HCPCS code C9358 was changed in group 1

A2005.14 R10NAS added Q4115,Q4116, C9360 & C9363 to the Non-Covered Products. The TOB 71x and 73x wereremoved from this LCD.

08/08/2009 - This policy was updated by the ICD-9 2009-2010 Annual Update.

08/11/2009-Annual review of this LCD has been completed. No updates were needed at this time.

A2005.14 R11The following has been added to this LCD due to a valid reconsideration request:Under section: Indications and Limitations of Coverage and/or Medical Necessity7. NAS will also cover venous stasis ulcers of the lower extremities which occur in the absence of obviousvaricosities, but which are the result of the same hemodynamic changes that commonly result in varicosities.Under section: ICD-9 Codes that Support Medically Necessity-Group 2B & 4B459.81-VENOUS (PERIPHERAL) INSUFFICIENCY, UNSPECIFIED

Due to a clerical error brought to our attention the following has been removed from the narrative section "forQ4102 (Oasis&reg)" and added under the section ,"for Q4106 (Dermagraf&reg):

“Critical Access Hospitals billing Method II should note, however, that the product has been valued accordingto a 90-day global period under the Physician Fee Schedule. Therefore, the application will be paid no morefrequently than at 90-day intervals for physicians. The facility may bill for application and product at afrequency appropriate to the clinical circumstances.”

Reason for Change

Last Reviewed On Date

08/11/2009

Related Documents

This LCD has no Related Documents.

LCD Attachments

There are no attachments for this LCD.

All Versions

Updated on 12/09/2009 with effective dates 01/01/2010 - N/A


Updated on 08/28/2009 with effective dates 07/01/2009 - 12/31/2009















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