Application of Bioengineered Skin Substitutes (L30135)
Contractor Information
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Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402 |
Contractor Type Carrier - FI - MAC |
LCD Information
Document Information
L30135 LCD Title Application of Bioengineered Skin Substitutes Contractor's Determination Number GSURG-052 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
Oversight Region Original Determination Effective Date For services performed on or after 08/16/2009 Original Determination Ending Date Revision Effective Date For services performed on or after 05/01/2012 Revision Ending Date |
CMS National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A)
Title XVIII of the Social Security Act, Section 1833(e
CMS Manual System, Pub 100-2, Medicare Benefit Policy Manual, Chapter 16, §180
CMS Manual System, Pub 100-4, Medicare Claims Processing Manual,
Chapter 17, §40 - Discarded drugs and biologicals.
Title XVIII of the Social Security Act, Section 1833(e
CMS Manual System, Pub 100-2, Medicare Benefit Policy Manual, Chapter 16, §180
CMS Manual System, Pub 100-4, Medicare Claims Processing Manual,
Chapter 17, §40 - Discarded drugs and biologicals.
Indications and Limitations of Coverage and/or Medical Necessity
Note:
Providers should seek information related to National Coverage
Determinations (NCD) and other Centers for Medicare & Medicaid
Services (CMS) instructions in CMS Manuals. This LCD only pertains to
the contractor's discretionary coverage related to this service.
This LCD covers the use of skin substitutes and related products in the treatment of lower extremity ulcer disease. The LCD does not pertain or otherwise apply to the use of any skin substitutes or related products in the treatment of burns, skin cancer, or for true reconstructive surgery.
Indications
Application of Bioengineered Skin Substitutes will be covered when the following conditions are met and documented 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 to documented conservative measures for greater than two (2) months' duration
3. Presence of neuropathic diabetic foot ulcers that have failed to respond to documented conservative measures for greater than one (1) month's duration. These measures must include appropriate steps to off-load pressure during treatment.
4. Presence of partial or full-thickness ulcers
5. Measurements of the initial ulcer size, the size following cessation of any conservative management and the size at the beginning of skin substitute treatment.
In all cases, the ulcer must be free of infection and underlying osteomyelitis. Documentation must be provided that these conditions have been successfully treated, resolved, prior to instituting skin substitute treatment.
Surgical Preparation for Initial Wound Recipient Site Preparation
CPT codes 15002-15005 Surgical Preparation
Note: CPT codes 15002-15005 describe burn and wound preparation or incisional or excisional release of scar contracture resulting in an open wound requiring a skin graft. These CPT codes are appropriately used in place of service inpatient hospital, outpatient hospital, ambulatory surgical center or office surgical suite with regional or general anesthesia to resurface an area damaged by burns, traumatic injury or surgery. An operative report is required and must be available upon request. If this procedure is performed in an office the claim can be resubmitted with a request for a redetermination and the medical staff will give the claim individual consideration.
Surgical preparation codes 15002 - 15005 for skin replacement surgery describe in initial services related to preparing a clean and viable wound service for placement of an autograft, flap, skin substitute graft, or for negative pressure wound therapy. Select the appropriate code from 15002 - 15005 based upon location and size of the resultant defect.
Surgical Preparation of Wound prior to Application of Skin Substitute
Repair of donor site requiring skin graft or local flaps is reported separately. Removal of current graft and/or simple cleansing of the wound is included, when performed.
Do not report CPT code 97602. Debridement is considered a separate procedure only when gross contamination requires prolonged cleansing, when appreciable amounts of devitalized or contaminated tissue are removed, or when debridement is carried out separately without immediate primary closure. Select the appropriate code from CPT codes 15271-15278 based upon location and size of the defect. For multiple wounds, sum the surface area of all wounds from all anatomic sites that are grouped together into the same code descriptor. For example, sum the surface area of all wounds on the trunk and arms. Do not sum wounds from different groupings of anatomic sites (eg, face and arms).
Medicare B accepts the Federal Drug Administration's (FDA) classification and description of any bioengineered skin substitute. Application of a Bioengineered Skin Substitute is covered when the following conditions are met and documented as appropriate for the individual patient:
1. Beneficiaries with diabetes under current medical management and controlled with stable HgbA1c level.
2. Venous stasis ulcers that have failed to heal, using conservative measures, within three months.
3. Neuropathic diabetic foot ulcers that have failed to heal, using conservative measures, within one month.
4. Ulcers that, do not involve tendon, muscle or joint capsule, or have bone exposure, extend through the dermis.
5. Beneficiaries with adequate arterial blood supply to the foot evidenced by a palpable pulse on the foot (either dorsalis pedis or posterior tibial artery) or an Ankle Brachial Index (ABI) of 0.7 or greater
6. Neuropathic diabetic foot ulcers that have been treated with appropriate steps to off-load pressure.
7. The ulcer must be free of infection and underlying osteomyelitis
The following Skin Substitutes are covered under Medicare in place of service inpatient hospital, outpatient hospital, ambulatory surgical center, or office setting:
Q4101 Skin substitute, apligraf, per square centimeter
Q4102 Skin substitute, oasis wound matrix, per square centimeter
Q4106 Skin substitute, dermagraft, per square centimeter
Q4107 Graftjacket, per square centimeter
Q4110 Skin substitute, primatrix, per square centimeter
All products must be:
Q4101 Skin substitute, apligraf, per square centimeter
Dermal and epidermal, (substitute) tissue of human origin, with or without bioengineered or processed elements, with metabolically active elements, per square centimeter
1. This product is a manufactured viable bilaminate graft or skin substitute designed to be used for treatment of non-infected, partial, and full thickness skin ulcers due to venous insufficiency or neuropathic diabetic foot ulcers.
2. For any product appropriately billed under this code, there must be documentation that the FDA labeling instructions including at least the criteria, frequency and acceptable duration of treatment were followed.
3. If the skin product is going to be billed to Medicare Part B, it must be billed on the same claim as the surgical application of the product.
Q4102 Skin substitute, oasis wound matrix, per square centimeter
Dermal (substitute) tissue of non-human origin, with or without other bioengineered or processed elements, with metabolically active elements, per square centimeter.
1. The product is intended to be used for the management of wounds including:
2. This product is covered when the medical record clearly documents that the product is being used in an office or clinic based comprehensive, organized wound management program.
Q4106 Skin substitute, dermagraft, per square centimeter
Dermal (substitute) tissue of human, with or without other bioengineered or processed elements, with metabolically active elements, per square centimeter
1. This product is covered for the treatment of full-thickness diabetic foot ulcers of greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure.
2. This product is covered when the medical record clearly documents that the product is being used in an office or clinic based comprehensive, organized wound management program.
Q4107 - Graftjacket, per square centimeter
GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair will be considered reasonable and necessary for treatment of neuropathic diabetic foot ulcers (DFU) with all the following conditions:
1. Patient has a current medical diagnosis of either Type I or Type II diabetes mellitus; and
2. Patient does not have a current HbA1C reading exceeding 12%; and
3. Full thickness ulcers of greater than three weeks duration that extend through the dermis but without tendon, muscle, capsule or bone exposure; and
4. Underlying disease process(es) contributing to the ulcer, e.g., diabetes, is adequately treated and documented; and
5. Ulcers are located on the foot or toes and are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels or tracts, eschar or any necrotic material that could interfere with the adherence of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair and the process of wound healing; and
6. Patient must have adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in the limb undergoing the procedure.
GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair must be used in conjunction with the following standard conservative measures:
1. Pressure-reducing footwear;
2. Non-weight bearing regimen;
3. Debridement of necrotic and callused tissue when necessary; and
4. Acceptable standard methods of wound care, such as saline moistened dressings.
The patient must be competent and/or have the support system required to participate in follow-up care associated with treatment of the wound with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair.
Limitations:
The use of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair on ulcers with any of the following conditions is considered not reasonable and necessary.
1. Cellulitis
2. Osteomyelitis
3. Necrotic ulcer
4. Draining wound
5. Bone exposed wound bed
6. Clinically significant wound healing impairment due to uncontrolled diabetes, poor nutrition and/or general medical condition
7. Autoimmune connective tissue disease
A single application of Acellular Dermal Tissue Matrix for any particular ulcer is usually all that is required to achieve wound healing in those wounds that are likely to be helped by this therapy. Treatment with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair is usually expected to last no more than twelve (12) weeks and to involve a maximum of two applications for any ulcer that initially qualifies for treatment. The use of more than two applications for the same ulcer is not considered reasonable and necessary. Re-application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair within three weeks for the same ulcer is not considered reasonable and necessary. Re-application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair where initial application has resulted in no decrease in size or depth of the wound or increase in granulation tissue, epithelialization, or progress towards closing, will be denied as not reasonable and necessary. Retreatment within one year following the last successful application with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer is not considered reasonable and necessary. Retreatment of an ulcer following two failed GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair applications is not considered reasonable and necessary.
This product is covered when the medical record clearly documents that the product is being used in an office or clinic based comprehensive, organized wound management program. This is a physicians service and may only be covered when applied by a physician or Medicare non-physician practitioner such as a Physician Assistant, Clinical Nurse Specialists (CNS) or Nurse Practitioner (NP).
When this service is rendered in place of service office, both the application of the skin graft and the product used must be billed on the same claim.
Use of GRAFTJACKET® XPRESS Flowable Soft Tissue Scaffold is considered investigational and is not covered.
Q4110 - Skin substitute, primatrix, per square centimeter
Primatrix is intended for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers, tunneled /undermined wounds, surgical wounds (donor sites / grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, and skin tears), draining wounds. http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090812.pdf
1. When this service is rendered in place of service office, both the application of the skin graft and the product used must be billed on the same claim.
2. These codes may not be billed with a modifier 58 (staged procedure).
The following skin product is also covered:
Q4121 TheraSkin®, per square centimeter
TheraSkin® will be considered reasonable and necessary when the following conditions are satisfied and documented when used with standard therapeutic compression for venous stasis ulcer (VSU):
1. Only for ulcers that have failed to respond to documented conservative measures of greater than six (6) weeks in duration, that have at minimum included regular dressing changes, debridement of necrotic tissue and standard therapeutic compression. 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, following cessation of conservative or conventional management. Documentation should also include measurement of the ulcer immediately prior to the placement of TheraSkin®.
2. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g. hypertension, is provided and documented in conjunction with the treatment; and
3. Only for ulcers that are free of infection, redness, drainage, underlying osteomyelitis, surround cellulitis, sinus tracts or tunnels, eschar or any necrotic material that could interfere with the adherence of TheraSkin® and wound healing.
When used with standard diabetic foot ulcer care for neuropathic Diabetic Foot Ulcer (DFU)s:
1. Only if the patient has the current medical diagnosis of either Type I or Type II diabetes mellitus;
2. Only if the patient does not have a current HbA1C reading exceeding 12%;
3. Only for full thickness ulcers of greater than three weeks in duration, which extend through the dermis, with or without tendon, muscle, capsule or bone exposure;
4. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g., diabetes is provided and documented in conjunction with treatment; and
5. Only for ulcers located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material that could interfere with the adherence of TheraSkin®, and the process of wound healing.
For both VSUs and DFUs all of the following must also be satisfied and documented:
1. The patient must have adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in limb undergoing the procedure;
2. TheraSkin® treatment must be used in conjunction with following standard conservative measures:
a. Use of pressure-reducing footwear;
b. A non-weight bearing regiment;
c. Debridement of necrotic and callused tissue when necessary; and
d. Acceptable methods of wound care, such as saline moistened dressings
The patient must be competent and/or have the support system required to participate in follow-up care associated with treatment of the wound with TheraSkin®.
The use of TheraSkin® on ulcers with any of the following conditions is considered not necessary and reasonable, and will result in denial of a claim:
1. cellulitis;
2. osteomyelitis;
3. necrotic ulcer;
4. draining wound; or
5. clinically significant wound healing impairment due to uncontrolled diabetes.
Limitations
Due to marked propensity for misuse of the entire range of "skin substitute" products, reimbursement may be made only when the medical record clearly documents that these products have been used in a comprehensive, organized wound management program.
1. There should be no fewer than two (2) weeks between applications for venous stasis ulcers and there should be no fewer than three (3) weeks between applications for neuropathic diabetic foot ulcers, except when more frequent applications are either a part of the FDA product specific labeling instructions or are clearly supported by medical record documentation of medically reasonable and necessary indications.
2. Treatment of any ulcer will typically last no more than twelve (12) weeks.
3. If after twelve (12) weeks of compression treatment and the appropriate number of applications of the skin substitutes a 50 percent or greater improvement is noted and documented, then one or more subsequent re-application of the skin substitute will be considered for Medicare coverage. Otherwise, re-application of the skin substitute is not recommended and other treatment modalities should be considered.
4. Re-treatment within one (1) year of completion of any given course of skin substitutes for venous stasis ulcers is not covered.
5. For neuropathic diabetic foot ulcers, if after nine (9) weeks of treatment, satisfactory healing progress is not noted, then re-application of the skin substitute is not recommended and other treatment modalities should be considered.
6. All products, unless they are specifically FDA-labeled for use in the types of ulcers considered in this LCD, will be considered to be - at most - "biologic wound dressings" and part of the relevant Evaluation & Management (E/M) service provided and not separately payable. Furthermore, even in those instances when the labeled indications include venous stasis or neuropathic diabetic ulcers, if the product is not biologically active, they will be considered as not covered under the terms of this LCD.
7. Application of the wound dressing is included in the payment for the E&M service and should not be billed a separately; when the is provided on the same or a previous day,
8. Providers are reminded that CPT code Manual language in the introductory comments to the "Skin Replacement Surgery and Skin Substitutes" chapter reconfirms this position in stating, "Identify by size€¦ and the type of graft or skin substitute; includes simple debridement of granulation tissue or recent avulsion." (Emphasis WPS) When more substantial debridement is warranted, consider use of one of the debridement codes. In either instance, the medical record documentation must clearly support the medically reasonable and necessary of the debridement of the wound.
9. Minimal wound preparation is considered a part of the procedure. All other products are included in the Evaluation & Management (E/M) service and are not separately payable.
10. Application skin substitutes/skin grafts must be performed in place of service inpatient hospital, outpatient hospital, ambulatory surgical center or office
11. The repair of ventral hernias, should be billed as CPT 49568(Implantation of mesh or other prosthesis of open incision of ventral hernia repair).
Note: Medicare Part B is not changing the way the payment amounts are determined for the skin care products with the new HCPCS codes. To the extent that single source drugs or biologicals were within the same billing and payment code, Medicare Part B will continue to treat them as multiple source drugs for payment purposes as required by Section 1847A(c)(6)(C)(ii).
This LCD covers the use of skin substitutes and related products in the treatment of lower extremity ulcer disease. The LCD does not pertain or otherwise apply to the use of any skin substitutes or related products in the treatment of burns, skin cancer, or for true reconstructive surgery.
Indications
Application of Bioengineered Skin Substitutes will be covered when the following conditions are met and documented 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 to documented conservative measures for greater than two (2) months' duration
3. Presence of neuropathic diabetic foot ulcers that have failed to respond to documented conservative measures for greater than one (1) month's duration. These measures must include appropriate steps to off-load pressure during treatment.
4. Presence of partial or full-thickness ulcers
5. Measurements of the initial ulcer size, the size following cessation of any conservative management and the size at the beginning of skin substitute treatment.
In all cases, the ulcer must be free of infection and underlying osteomyelitis. Documentation must be provided that these conditions have been successfully treated, resolved, prior to instituting skin substitute treatment.
Surgical Preparation for Initial Wound Recipient Site Preparation
CPT codes 15002-15005 Surgical Preparation
Note: CPT codes 15002-15005 describe burn and wound preparation or incisional or excisional release of scar contracture resulting in an open wound requiring a skin graft. These CPT codes are appropriately used in place of service inpatient hospital, outpatient hospital, ambulatory surgical center or office surgical suite with regional or general anesthesia to resurface an area damaged by burns, traumatic injury or surgery. An operative report is required and must be available upon request. If this procedure is performed in an office the claim can be resubmitted with a request for a redetermination and the medical staff will give the claim individual consideration.
Surgical preparation codes 15002 - 15005 for skin replacement surgery describe in initial services related to preparing a clean and viable wound service for placement of an autograft, flap, skin substitute graft, or for negative pressure wound therapy. Select the appropriate code from 15002 - 15005 based upon location and size of the resultant defect.
Surgical Preparation of Wound prior to Application of Skin Substitute
Repair of donor site requiring skin graft or local flaps is reported separately. Removal of current graft and/or simple cleansing of the wound is included, when performed.
Do not report CPT code 97602. Debridement is considered a separate procedure only when gross contamination requires prolonged cleansing, when appreciable amounts of devitalized or contaminated tissue are removed, or when debridement is carried out separately without immediate primary closure. Select the appropriate code from CPT codes 15271-15278 based upon location and size of the defect. For multiple wounds, sum the surface area of all wounds from all anatomic sites that are grouped together into the same code descriptor. For example, sum the surface area of all wounds on the trunk and arms. Do not sum wounds from different groupings of anatomic sites (eg, face and arms).
Medicare B accepts the Federal Drug Administration's (FDA) classification and description of any bioengineered skin substitute. Application of a Bioengineered Skin Substitute is covered when the following conditions are met and documented as appropriate for the individual patient:
1. Beneficiaries with diabetes under current medical management and controlled with stable HgbA1c level.
2. Venous stasis ulcers that have failed to heal, using conservative measures, within three months.
3. Neuropathic diabetic foot ulcers that have failed to heal, using conservative measures, within one month.
4. Ulcers that, do not involve tendon, muscle or joint capsule, or have bone exposure, extend through the dermis.
5. Beneficiaries with adequate arterial blood supply to the foot evidenced by a palpable pulse on the foot (either dorsalis pedis or posterior tibial artery) or an Ankle Brachial Index (ABI) of 0.7 or greater
6. Neuropathic diabetic foot ulcers that have been treated with appropriate steps to off-load pressure.
7. The ulcer must be free of infection and underlying osteomyelitis
The following Skin Substitutes are covered under Medicare in place of service inpatient hospital, outpatient hospital, ambulatory surgical center, or office setting:
Q4101 Skin substitute, apligraf, per square centimeter
Q4102 Skin substitute, oasis wound matrix, per square centimeter
Q4106 Skin substitute, dermagraft, per square centimeter
Q4107 Graftjacket, per square centimeter
Q4110 Skin substitute, primatrix, per square centimeter
All products must be:
- Provided in accordance with the material's Food and Drug Administration- (FDA) approved package label.
- Applied to partial- or full-thickness wounds (see individual product information for labeled indications) not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts
- Applied in a frequency that is supported either by the FDA product specific labeling instructions or are clearly supported by documentation in the medical record showing the medical reasonable and necessary indications.
Q4101 Skin substitute, apligraf, per square centimeter
Dermal and epidermal, (substitute) tissue of human origin, with or without bioengineered or processed elements, with metabolically active elements, per square centimeter
1. This product is a manufactured viable bilaminate graft or skin substitute designed to be used for treatment of non-infected, partial, and full thickness skin ulcers due to venous insufficiency or neuropathic diabetic foot ulcers.
2. For any product appropriately billed under this code, there must be documentation that the FDA labeling instructions including at least the criteria, frequency and acceptable duration of treatment were followed.
3. If the skin product is going to be billed to Medicare Part B, it must be billed on the same claim as the surgical application of the product.
Q4102 Skin substitute, oasis wound matrix, per square centimeter
Dermal (substitute) tissue of non-human origin, with or without other bioengineered or processed elements, with metabolically active elements, per square centimeter.
1. The product is intended to be used for the management of wounds including:
- Treatment of neuropathic diabetic foot ulcers that have failed conservative measures of at least four weeks duration.
- Treatment of partial and full-thickness skin venous insufficiency ulcers present for a minimum of four weeks duration and have failed conventional treatment for at least two weeks.
- Skin substitute used in conjunction with standard wound care regiment.
2. This product is covered when the medical record clearly documents that the product is being used in an office or clinic based comprehensive, organized wound management program.
Q4106 Skin substitute, dermagraft, per square centimeter
Dermal (substitute) tissue of human, with or without other bioengineered or processed elements, with metabolically active elements, per square centimeter
1. This product is covered for the treatment of full-thickness diabetic foot ulcers of greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure.
2. This product is covered when the medical record clearly documents that the product is being used in an office or clinic based comprehensive, organized wound management program.
Q4107 - Graftjacket, per square centimeter
GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair will be considered reasonable and necessary for treatment of neuropathic diabetic foot ulcers (DFU) with all the following conditions:
1. Patient has a current medical diagnosis of either Type I or Type II diabetes mellitus; and
2. Patient does not have a current HbA1C reading exceeding 12%; and
3. Full thickness ulcers of greater than three weeks duration that extend through the dermis but without tendon, muscle, capsule or bone exposure; and
4. Underlying disease process(es) contributing to the ulcer, e.g., diabetes, is adequately treated and documented; and
5. Ulcers are located on the foot or toes and are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels or tracts, eschar or any necrotic material that could interfere with the adherence of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair and the process of wound healing; and
6. Patient must have adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in the limb undergoing the procedure.
GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair must be used in conjunction with the following standard conservative measures:
1. Pressure-reducing footwear;
2. Non-weight bearing regimen;
3. Debridement of necrotic and callused tissue when necessary; and
4. Acceptable standard methods of wound care, such as saline moistened dressings.
The patient must be competent and/or have the support system required to participate in follow-up care associated with treatment of the wound with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair.
Limitations:
The use of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair on ulcers with any of the following conditions is considered not reasonable and necessary.
1. Cellulitis
2. Osteomyelitis
3. Necrotic ulcer
4. Draining wound
5. Bone exposed wound bed
6. Clinically significant wound healing impairment due to uncontrolled diabetes, poor nutrition and/or general medical condition
7. Autoimmune connective tissue disease
A single application of Acellular Dermal Tissue Matrix for any particular ulcer is usually all that is required to achieve wound healing in those wounds that are likely to be helped by this therapy. Treatment with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair is usually expected to last no more than twelve (12) weeks and to involve a maximum of two applications for any ulcer that initially qualifies for treatment. The use of more than two applications for the same ulcer is not considered reasonable and necessary. Re-application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair within three weeks for the same ulcer is not considered reasonable and necessary. Re-application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair where initial application has resulted in no decrease in size or depth of the wound or increase in granulation tissue, epithelialization, or progress towards closing, will be denied as not reasonable and necessary. Retreatment within one year following the last successful application with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer is not considered reasonable and necessary. Retreatment of an ulcer following two failed GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair applications is not considered reasonable and necessary.
This product is covered when the medical record clearly documents that the product is being used in an office or clinic based comprehensive, organized wound management program. This is a physicians service and may only be covered when applied by a physician or Medicare non-physician practitioner such as a Physician Assistant, Clinical Nurse Specialists (CNS) or Nurse Practitioner (NP).
When this service is rendered in place of service office, both the application of the skin graft and the product used must be billed on the same claim.
Use of GRAFTJACKET® XPRESS Flowable Soft Tissue Scaffold is considered investigational and is not covered.
Q4110 - Skin substitute, primatrix, per square centimeter
Primatrix is intended for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers, tunneled /undermined wounds, surgical wounds (donor sites / grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, and skin tears), draining wounds. http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090812.pdf
1. When this service is rendered in place of service office, both the application of the skin graft and the product used must be billed on the same claim.
2. These codes may not be billed with a modifier 58 (staged procedure).
The following skin product is also covered:
Q4121 TheraSkin®, per square centimeter
TheraSkin® will be considered reasonable and necessary when the following conditions are satisfied and documented when used with standard therapeutic compression for venous stasis ulcer (VSU):
1. Only for ulcers that have failed to respond to documented conservative measures of greater than six (6) weeks in duration, that have at minimum included regular dressing changes, debridement of necrotic tissue and standard therapeutic compression. 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, following cessation of conservative or conventional management. Documentation should also include measurement of the ulcer immediately prior to the placement of TheraSkin®.
2. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g. hypertension, is provided and documented in conjunction with the treatment; and
3. Only for ulcers that are free of infection, redness, drainage, underlying osteomyelitis, surround cellulitis, sinus tracts or tunnels, eschar or any necrotic material that could interfere with the adherence of TheraSkin® and wound healing.
When used with standard diabetic foot ulcer care for neuropathic Diabetic Foot Ulcer (DFU)s:
1. Only if the patient has the current medical diagnosis of either Type I or Type II diabetes mellitus;
2. Only if the patient does not have a current HbA1C reading exceeding 12%;
3. Only for full thickness ulcers of greater than three weeks in duration, which extend through the dermis, with or without tendon, muscle, capsule or bone exposure;
4. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g., diabetes is provided and documented in conjunction with treatment; and
5. Only for ulcers located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material that could interfere with the adherence of TheraSkin®, and the process of wound healing.
For both VSUs and DFUs all of the following must also be satisfied and documented:
1. The patient must have adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in limb undergoing the procedure;
2. TheraSkin® treatment must be used in conjunction with following standard conservative measures:
a. Use of pressure-reducing footwear;
b. A non-weight bearing regiment;
c. Debridement of necrotic and callused tissue when necessary; and
d. Acceptable methods of wound care, such as saline moistened dressings
The patient must be competent and/or have the support system required to participate in follow-up care associated with treatment of the wound with TheraSkin®.
The use of TheraSkin® on ulcers with any of the following conditions is considered not necessary and reasonable, and will result in denial of a claim:
1. cellulitis;
2. osteomyelitis;
3. necrotic ulcer;
4. draining wound; or
5. clinically significant wound healing impairment due to uncontrolled diabetes.
Limitations
Due to marked propensity for misuse of the entire range of "skin substitute" products, reimbursement may be made only when the medical record clearly documents that these products have been used in a comprehensive, organized wound management program.
1. There should be no fewer than two (2) weeks between applications for venous stasis ulcers and there should be no fewer than three (3) weeks between applications for neuropathic diabetic foot ulcers, except when more frequent applications are either a part of the FDA product specific labeling instructions or are clearly supported by medical record documentation of medically reasonable and necessary indications.
2. Treatment of any ulcer will typically last no more than twelve (12) weeks.
3. If after twelve (12) weeks of compression treatment and the appropriate number of applications of the skin substitutes a 50 percent or greater improvement is noted and documented, then one or more subsequent re-application of the skin substitute will be considered for Medicare coverage. Otherwise, re-application of the skin substitute is not recommended and other treatment modalities should be considered.
4. Re-treatment within one (1) year of completion of any given course of skin substitutes for venous stasis ulcers is not covered.
5. For neuropathic diabetic foot ulcers, if after nine (9) weeks of treatment, satisfactory healing progress is not noted, then re-application of the skin substitute is not recommended and other treatment modalities should be considered.
6. All products, unless they are specifically FDA-labeled for use in the types of ulcers considered in this LCD, will be considered to be - at most - "biologic wound dressings" and part of the relevant Evaluation & Management (E/M) service provided and not separately payable. Furthermore, even in those instances when the labeled indications include venous stasis or neuropathic diabetic ulcers, if the product is not biologically active, they will be considered as not covered under the terms of this LCD.
7. Application of the wound dressing is included in the payment for the E&M service and should not be billed a separately; when the is provided on the same or a previous day,
8. Providers are reminded that CPT code Manual language in the introductory comments to the "Skin Replacement Surgery and Skin Substitutes" chapter reconfirms this position in stating, "Identify by size€¦ and the type of graft or skin substitute; includes simple debridement of granulation tissue or recent avulsion." (Emphasis WPS) When more substantial debridement is warranted, consider use of one of the debridement codes. In either instance, the medical record documentation must clearly support the medically reasonable and necessary of the debridement of the wound.
9. Minimal wound preparation is considered a part of the procedure. All other products are included in the Evaluation & Management (E/M) service and are not separately payable.
10. Application skin substitutes/skin grafts must be performed in place of service inpatient hospital, outpatient hospital, ambulatory surgical center or office
11. The repair of ventral hernias, should be billed as CPT 49568(Implantation of mesh or other prosthesis of open incision of ventral hernia repair).
Note: Medicare Part B is not changing the way the payment amounts are determined for the skin care products with the new HCPCS codes. To the extent that single source drugs or biologicals were within the same billing and payment code, Medicare Part B will continue to treat them as multiple source drugs for payment purposes as required by Section 1847A(c)(6)(C)(ii).
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.
Revenue Codes:
CPT/HCPCS 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.
| 11042 | DEBRIDEMENT, SUBCUTANEOUS TISSUE (INCLUDES EPIDERMIS AND DERMIS, IF PERFORMED); FIRST 20 SQ CM OR LESS |
| 11043 | DEBRIDEMENT, MUSCLE AND/OR FASCIA (INCLUDES EPIDERMIS, DERMIS, AND SUBCUTANEOUS TISSUE, IF PERFORMED); FIRST 20 SQ CM OR LESS |
| 11044 | DEBRIDEMENT, BONE (INCLUDES EPIDERMIS, DERMIS, SUBCUTANEOUS TISSUE, MUSCLE AND/OR FASCIA, IF PERFORMED); FIRST 20 SQ CM OR LESS |
| 11045 | DEBRIDEMENT, SUBCUTANEOUS TISSUE (INCLUDES EPIDERMIS AND DERMIS, IF PERFORMED); EACH ADDITIONAL 20 SQ CM, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 11046 | DEBRIDEMENT, MUSCLE AND/OR FASCIA (INCLUDES EPIDERMIS, DERMIS, AND SUBCUTANEOUS TISSUE, IF PERFORMED); EACH ADDITIONAL 20 SQ CM, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 11047 | DEBRIDEMENT, BONE (INCLUDES EPIDERMIS, DERMIS, SUBCUTANEOUS TISSUE, MUSCLE AND/OR FASCIA, IF PERFORMED); EACH ADDITIONAL 20 SQ CM, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 15002 | SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, TRUNK, ARMS, LEGS; FIRST 100 SQ CM OR 1% OF BODY AREA OF INFANTS AND CHILDREN |
| 15003 | SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, TRUNK, ARMS, LEGS; EACH ADDITIONAL 100 SQ CM, OR PART THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 15004 | SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET AND/OR MULTIPLE DIGITS; FIRST 100 SQ CM OR 1% OF BODY AREA OF INFANTS AND CHILDREN |
| 15005 | SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET AND/OR MULTIPLE DIGITS; EACH ADDITIONAL 100 SQ CM, OR PART THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 15271 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA UP TO 100 SQ CM; FIRST 25 SQ CM OR LESS WOUND SURFACE AREA |
| 15272 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA UP TO 100 SQ CM; EACH ADDITIONAL 25 SQ CM WOUND SURFACE AREA, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 15273 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA GREATER THAN OR EQUAL TO 100 SQ CM; FIRST 100 SQ CM WOUND SURFACE AREA, OR 1% OF BODY AREA OF INFANTS AND CHILDREN |
| 15274 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA GREATER THAN OR EQUAL TO 100 SQ CM; EACH ADDITIONAL 100 SQ CM WOUND SURFACE AREA, OR PART THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 15275 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA UP TO 100 SQ CM; FIRST 25 SQ CM OR LESS WOUND SURFACE AREA |
| 15276 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA UP TO 100 SQ CM; EACH ADDITIONAL 25 SQ CM WOUND SURFACE AREA, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| 15277 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA GREATER THAN OR EQUAL TO 100 SQ CM; FIRST 100 SQ CM WOUND SURFACE AREA, OR 1% OF BODY AREA OF INFANTS AND CHILDREN |
| 15278 | APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA GREATER THAN OR EQUAL TO 100 SQ CM; EACH ADDITIONAL 100 SQ CM WOUND SURFACE AREA, OR PART THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) |
| Q4101 | APLIGRAF, PER SQUARE CENTIMETER |
| Q4102 | OASIS WOUND MATRIX, PER SQUARE CENTIMETER |
| Q4106 | DERMAGRAFT, PER SQUARE CENTIMETER |
| Q4107 | GRAFTJACKET, PER SQUARE CENTIMETER |
| Q4110 | PRIMATRIX, PER SQUARE CENTIMETER |
| Q4121 | THERASKIN, PER SQUARE CENTIMETER |
Non Covered
| Q4100 | SKIN SUBSTITUTE, NOT OTHERWISE SPECIFIED |
| Q4103 | OASIS BURN MATRIX, PER SQUARE CENTIMETER |
| Q4104 | INTEGRA BILAYER MATRIX WOUND DRESSING (BMWD), PER SQUARE CENTIMETER |
| Q4105 | INTEGRA DERMAL REGENERATION TEMPLATE (DRT), PER SQUARE CENTIMETER |
| Q4108 | INTEGRA MATRIX, 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 |
| Q4116 | ALLODERM, 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 |
| Q4122 | DERMACELL, PER SQUARE CENTIMETER |
| Q4123 | ALLOSKIN RT, PER SQUARE CENTIMETER |
| Q4124 | OASIS ULTRA TRI-LAYER WOUND MATRIX, 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
List 1A-Primary diagnoses:
| 454.0 | VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER |
| 454.2 | VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION |
| 459.10 | POSTPHLEBETIC SYNDROME WITHOUT COMPLICATIONS |
| 459.11 | POSTPHLEBETIC SYNDROME WITH ULCER |
| 459.81 | VENOUS (PERIPHERAL) INSUFFICIENCY UNSPECIFIED |
| 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 |
| 249.60 | SECONDARY DIABETES MELLITUS WITH NEUROLOGICAL MANIFESTATIONS, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED |
| 249.70 | SECONDARY DIABETES MELLITUS WITH PERIPHERAL CIRCULATORY DISORDERS, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED |
| 250.60 | DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED |
| 250.61 | DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED |
| 250.70 | DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED |
| 250.71 | DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED |
| 250.80 | DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED |
| 250.81 | DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED |
| 250.82 | DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, UNCONTROLLED |
| 250.83 | DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED |
Diagnoses that Support Medical Necessity
See ICD-9 list
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, including but not limited to ICD-9 codes related to
the following diagnoses:
1. Infected ulcer
2. Osteomyelitis
3. Allergy to bovine collagen
4. Neuropathic diabetic foot ulcers without pedal pulses
5. Uncontrolled diabetes ("controlled" diabetes for purposes of this policy would be based on documentation in the medical record of the HgbAlc level)
6. Active Charcot arthropathy of the ulcer extremity
7. Vasculitis
8. Uncontrolled rheumatoid arthritis and/or rheumatoid ulcers
9. Other uncontrolled collagen vascular disease
10. Patients being treated with high dose corticosteroids or immunosuppressants
11. Patients who have undergone radiation and/or chemotherapy within the month immediately proceeding proposed skin substitute treatment.
12. The service is considered investigational and/or for cosmetic purposes,
1. Infected ulcer
2. Osteomyelitis
3. Allergy to bovine collagen
4. Neuropathic diabetic foot ulcers without pedal pulses
5. Uncontrolled diabetes ("controlled" diabetes for purposes of this policy would be based on documentation in the medical record of the HgbAlc level)
6. Active Charcot arthropathy of the ulcer extremity
7. Vasculitis
8. Uncontrolled rheumatoid arthritis and/or rheumatoid ulcers
9. Other uncontrolled collagen vascular disease
10. Patients being treated with high dose corticosteroids or immunosuppressants
11. Patients who have undergone radiation and/or chemotherapy within the month immediately proceeding proposed skin substitute treatment.
12. The service is considered investigational and/or for cosmetic purposes,
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Ones that are not listed
General Information
The medical record
must clearly show that the criteria listed in "Indications and
Limitation of Coverage and/or Medical 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, if during treatment the ulcer
shows obvious signs of worsening or lack of treatment response,
continuing skin substitute treatment would be inappropriate absent
documentation of an appropriate rationale for doing so.
1. The medical record must clearly show that the criteria listed in "Indications and Limitations of Coverage and/or Medical Necessity" have been met.
2. The medical record must clearly document that conservative pre-treatment wound management has been tried and failed to induce healing.
3. There must be a documented plan of care with documented goals and documented provider follow-up present in the patient's medical record. Wound healing must be a medically reasonable expectation based on the clinical circumstances documented.
4. Documentation of the progress of the wound's response to treatment must be made for each service billed. At a minimum this must include current wound size, wound depth, presence and extent of or absence of obvious signs of infection, presence and extent of or absence of necrotic, devitalized or non-viable tissue, or other material in the wound that is expected to inhibit healing or promote adjacent tissue breakdown.
5. When debridements are performed, the debridement procedure notes must document tissue removal (i.e. skin, full or partial thickness; subcutaneous tissue; muscle; and/or bone), the method used to debride (i.e., hydrostatic versus sharp versus abrasion methods), and the character of the wound (including dimensions, description of necrotic material present, description of tissue removed, degree of epithelialization, etc.) before and after debridement.
6. Consistent with FDA product labeling, since the use of these products is limited to clean wounds, a description of wound must be documented in the medical records.
7. When, the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.
8. If the active wound care is needed to clean an infected wound, the service (CPT codes 97597 or 97598) is not expected to be needed more than once a week. The rationale and medical necessity for more frequent services must be clearly documented in the medical record.
9. The literature demonstrates that survival of Q4106 decreases significantly when the 24 steps noted in the FDA labeling are not followed. The documentation must show that these steps were followed.
10. The medical record must clearly document that conservative pre-treatment wound management has been tried and failed to induce healing. For Dermagraft® (Q4106) the record must document that the twenty-four (24) steps involved in the correct use of this product, as described in the clinical trials leading to FDA approval and included in the manufacturer's "Directions for Use", as of the date of development of this LCD have been followed. This requirement is based on the demonstrated decrement in survival of the dermal substitute when the 24 steps noted in the FDA labeling are not followed. The provider must take notice of these specific instructions for use. They will not be listed in this policy.
11. The medical record must document that wound treatment is accompanied by appropriate wound dressing during 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 and documented during such treatment.
12. In most instances, consistent with FDA product labeling and current CPT language included in the introductory information on the family of Skin Substitute codes that limits the use of these products to clean wounds, CPT code 15002-15005 are not appropriate. Standard, routine minimal wound preparation is considered a part of the procedure. In any instance of utilization of a separate debridement code, there is a high likelihood of Contractor record 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 that FDA-labeling should be reviewed in order to determine that the skin substitute itself is even indicated in such cases of significant same-day debridement.
The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.
When, the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.
1. The medical record must clearly show that the criteria listed in "Indications and Limitations of Coverage and/or Medical Necessity" have been met.
2. The medical record must clearly document that conservative pre-treatment wound management has been tried and failed to induce healing.
3. There must be a documented plan of care with documented goals and documented provider follow-up present in the patient's medical record. Wound healing must be a medically reasonable expectation based on the clinical circumstances documented.
4. Documentation of the progress of the wound's response to treatment must be made for each service billed. At a minimum this must include current wound size, wound depth, presence and extent of or absence of obvious signs of infection, presence and extent of or absence of necrotic, devitalized or non-viable tissue, or other material in the wound that is expected to inhibit healing or promote adjacent tissue breakdown.
5. When debridements are performed, the debridement procedure notes must document tissue removal (i.e. skin, full or partial thickness; subcutaneous tissue; muscle; and/or bone), the method used to debride (i.e., hydrostatic versus sharp versus abrasion methods), and the character of the wound (including dimensions, description of necrotic material present, description of tissue removed, degree of epithelialization, etc.) before and after debridement.
6. Consistent with FDA product labeling, since the use of these products is limited to clean wounds, a description of wound must be documented in the medical records.
7. When, the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.
8. If the active wound care is needed to clean an infected wound, the service (CPT codes 97597 or 97598) is not expected to be needed more than once a week. The rationale and medical necessity for more frequent services must be clearly documented in the medical record.
9. The literature demonstrates that survival of Q4106 decreases significantly when the 24 steps noted in the FDA labeling are not followed. The documentation must show that these steps were followed.
10. The medical record must clearly document that conservative pre-treatment wound management has been tried and failed to induce healing. For Dermagraft® (Q4106) the record must document that the twenty-four (24) steps involved in the correct use of this product, as described in the clinical trials leading to FDA approval and included in the manufacturer's "Directions for Use", as of the date of development of this LCD have been followed. This requirement is based on the demonstrated decrement in survival of the dermal substitute when the 24 steps noted in the FDA labeling are not followed. The provider must take notice of these specific instructions for use. They will not be listed in this policy.
11. The medical record must document that wound treatment is accompanied by appropriate wound dressing during 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 and documented during such treatment.
12. In most instances, consistent with FDA product labeling and current CPT language included in the introductory information on the family of Skin Substitute codes that limits the use of these products to clean wounds, CPT code 15002-15005 are not appropriate. Standard, routine minimal wound preparation is considered a part of the procedure. In any instance of utilization of a separate debridement code, there is a high likelihood of Contractor record 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 that FDA-labeling should be reviewed in order to determine that the skin substitute itself is even indicated in such cases of significant same-day debridement.
The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.
When, the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.
Appendices
Utilization Guidelines
1. If the
debridement of chronic ulcers requires more than eight services, the
rationale and medical necessity must be clearly documented in the
medical record.
2. It is expected that, within twelve weeks, a wound will reach a state at which its care should be performed primarily by the patient and/or the patient's caregiver with periodic provider assessment and supervision. Wound care that can be performed by the patient or the patient's caregiver is considered maintenance care. Re-assessment of a wound maintained by the patient or patient's caregiver is covered as an evaluation and management service.
3. For venous stasis ulcers, treatment will normally last no longer than twelve weeks. If after twelve weeks of compression treatment, satisfactory healing progress is not noted then reapplication of the skin substitute is not recommended and other treatment modalities should be considered.
4. For neuropathic diabetic foot ulcers, treatment will normally last no longer than twelve weeks. If after nine weeks of treatment, satisfactory healing progress is not noted, then reapplication of the skin substitute is not recommended and other treatment modalities should be considered.
5. No re-treatment would be expected within the first year following successful initial treatment.
HCPCS code Q4121 TheraSkin®
1. Treatment with Q4121 TheraSkin® is usually expected to last no more than twelve (12) weeks for any ulcer that initially qualifies for treatment.
2. Re-application of TheraSkin® within one week for the same ulcer is not considered reasonable and necessary and will not be reimbursed.
3. Re-application of TheraSkin® where initial application has resulted in no decrease in size or depth or increase in granulation tissue, epithelialization, or progress towards closing, will be denied as not reasonable and necessary and will not be reimbursed.
4. Re-treatment within one year following the last successful application with TheraSkin® is not considered reasonable and necessary, and will not be reimbursed.
5. Re-treatment of an ulcer following the unsuccessful treatment where it consisted of two failed TheraSkin® applications is not considered reasonable and necessary, and will not be reimbursed.
6. These codes are not intended to be reported for simple graft application alone or application stabilized with dressings (eg, by simple gauze wrap). The skin substitute/graft is anchored using the surgeon's choice of fixation. (CPT 2007). If it is not medically reasonable and necessary to anchor the TheraSkin®, (for example, due to size, depth or location of the wound), then the application is included in the appropriate E&M code and should not be submitted with the application codes.
2. It is expected that, within twelve weeks, a wound will reach a state at which its care should be performed primarily by the patient and/or the patient's caregiver with periodic provider assessment and supervision. Wound care that can be performed by the patient or the patient's caregiver is considered maintenance care. Re-assessment of a wound maintained by the patient or patient's caregiver is covered as an evaluation and management service.
3. For venous stasis ulcers, treatment will normally last no longer than twelve weeks. If after twelve weeks of compression treatment, satisfactory healing progress is not noted then reapplication of the skin substitute is not recommended and other treatment modalities should be considered.
4. For neuropathic diabetic foot ulcers, treatment will normally last no longer than twelve weeks. If after nine weeks of treatment, satisfactory healing progress is not noted, then reapplication of the skin substitute is not recommended and other treatment modalities should be considered.
5. No re-treatment would be expected within the first year following successful initial treatment.
HCPCS code Q4121 TheraSkin®
1. Treatment with Q4121 TheraSkin® is usually expected to last no more than twelve (12) weeks for any ulcer that initially qualifies for treatment.
2. Re-application of TheraSkin® within one week for the same ulcer is not considered reasonable and necessary and will not be reimbursed.
3. Re-application of TheraSkin® where initial application has resulted in no decrease in size or depth or increase in granulation tissue, epithelialization, or progress towards closing, will be denied as not reasonable and necessary and will not be reimbursed.
4. Re-treatment within one year following the last successful application with TheraSkin® is not considered reasonable and necessary, and will not be reimbursed.
5. Re-treatment of an ulcer following the unsuccessful treatment where it consisted of two failed TheraSkin® applications is not considered reasonable and necessary, and will not be reimbursed.
6. These codes are not intended to be reported for simple graft application alone or application stabilized with dressings (eg, by simple gauze wrap). The skin substitute/graft is anchored using the surgeon's choice of fixation. (CPT 2007). If it is not medically reasonable and necessary to anchor the TheraSkin®, (for example, due to size, depth or location of the wound), then the application is included in the appropriate E&M code and should not be submitted with the application codes.
Sources of Information and Basis for Decision
FDA Approval Notice, May 22, 1998 (Apligraf®); September 28, 2002
2. FDA Approval Notice, September 28, 2001 (Dermagraft®)
3. FDA Approval Notice for Neuropathic diabetic foot ulcers dated June 20, 2000
4. CMD Surgery/Surgery New Technology Workgroup
5. Template LMRP for bilaminate skin substitutes, developed by the CMD surgery/new technology surgery issues workgroup
6. Consultants from Podiatry, Vascular Surgery, Orthopedic Surgery Plastic Surgery
7. Falanga, V., & Sabolinski, M., "bilayered living skin construct (Apligraf®) accelerates complete closure of hard-to-heal venous ulcers," Wound Repair and Regeneration, vol. 7, No. 4, July-August 1999.
8. Prescribing Information: Apligraf® (Graftskin® (TM)), Organogenesis Inc.
9. Olin, J.W., Beussterien, K.M., Childs, M.B., Seavy, C., Griffiths, R.I., "œMedical costs of treating venous stasis ulcers: evidence from a retrospective cohort study," Vascular Medicine, volume 4, pp. 1-7, 1999.
10. Muhart, et al., Behavior of Tissue Engineered Skin, A Comparison of a Living Skin Equivalent Autograft, and Occlusive Dressing in Human Donor Sites. Archives of Dermatology, August 1999
11. Snyder, et al., Cadaveric Allograft as Adjunct Therapy for Nonhealing Ulcers, Journal of Foot and Ankle Surgery, March/April, 1999
12. Falanga, et al., Rapid Healing of Venous Ulcers and Lack of Clinical Rejection with an Allogenic Cultured Human Skin Equivalent, Archives of Dermatology, March, 1998
13. Change Request 1521, January 22, 2001
14. C. Keith Bowering, MD, The Use of Dermagraft® in the Treatment of Diabetic Foot Ulcers "“FRCP
15. Richard A. Pollak, DPM, et. al., and the Dermagraft® Diabetic Ulcer Study Group, A Human Dermal Replacement for the Treatment of Diabetic Foot Ulcers -
16. Gary D. Genzkow, MD, et. al. Improved Healing of Diabetic Foot Ulcers after Grafting with a Living Human Dermal Replacement - - The Dermagraft® Diabetic Ulcer Study Group
17. A Metabolically Active Human Dermal Replacement for the Treatment of Diabetic Foot Ulcers- Gail Naughton, Jonathan Mansbridge, and Gary Gentzkow
18. Update of FDA, Humanitarian Device Exemption HDE - H020004
19. Marston, W. A., J. Hanft, et al. (2003). "The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers: Results of a prospective randomized trial." Diabetes Care 26(6): 1701-5.
20. Marston, W. A., Risk Factors Associated with Healing Chronic Diabetic Foot Ulcers: The Importance of Hyperglycemia Ostomy/Wound Management - ISSN: 0889-5899 - Volume 52 - Issue 3 - March 2006 - Pages: 26 - 39
21. FDA Approval Notice, dated March 1, 1996 (Integra); April 19, 2002
23. FDA Approval Notice, dated July 19, 2006 (Oasis).
24. CPT changes 2006, An Insider's View, November 2006
25. Molnar, Joseph A., et al; Acceleration of Integra Incorporation in Complex Tissue Defects with Subatmospheric Pressure, Plastic & Reconstructive Surgery, Vol. 113 No. 5, April 2004
26. The FDA Center for Biologics Evaluation & Research, Processing of Orthopedic, Cardiovascular & Skin Allografts Workshop, November 11, 2007. http://www.fda.gov/cber/minutes/allog101107t.pdf
27. Division of Medical Assistance Clinical Coverage Policy No.: 1G-2 Bioengineered Skin Original Effective Date: November 1, 2000 Revised Date: May 1, 2007. http://www.ncdhhs.gov/dma/physician/1G2.pdf
28. Ben-Bassat H. Performance and safety of skin allografts. Clinics in Dermatology. 2005;23:365-375.
29. Landsman A. Management of complex wounds with fresh cryopreserved human allografts. NAJMS. 2010;3(1):14-16.
30. Snyder RJ. Treatment of nonhealing ulcers with allografts. Clinics in Dermatology. 2005;23:388-395.
31. Spence RJ, Wong L. The enhancement of wound healing with human skin allograft. Surgical Clinics of North America. 1997;77(3):731-745.
Advisory Committee Meeting Notes
2. FDA Approval Notice, September 28, 2001 (Dermagraft®)
3. FDA Approval Notice for Neuropathic diabetic foot ulcers dated June 20, 2000
4. CMD Surgery/Surgery New Technology Workgroup
5. Template LMRP for bilaminate skin substitutes, developed by the CMD surgery/new technology surgery issues workgroup
6. Consultants from Podiatry, Vascular Surgery, Orthopedic Surgery Plastic Surgery
7. Falanga, V., & Sabolinski, M., "bilayered living skin construct (Apligraf®) accelerates complete closure of hard-to-heal venous ulcers," Wound Repair and Regeneration, vol. 7, No. 4, July-August 1999.
8. Prescribing Information: Apligraf® (Graftskin® (TM)), Organogenesis Inc.
9. Olin, J.W., Beussterien, K.M., Childs, M.B., Seavy, C., Griffiths, R.I., "œMedical costs of treating venous stasis ulcers: evidence from a retrospective cohort study," Vascular Medicine, volume 4, pp. 1-7, 1999.
10. Muhart, et al., Behavior of Tissue Engineered Skin, A Comparison of a Living Skin Equivalent Autograft, and Occlusive Dressing in Human Donor Sites. Archives of Dermatology, August 1999
11. Snyder, et al., Cadaveric Allograft as Adjunct Therapy for Nonhealing Ulcers, Journal of Foot and Ankle Surgery, March/April, 1999
12. Falanga, et al., Rapid Healing of Venous Ulcers and Lack of Clinical Rejection with an Allogenic Cultured Human Skin Equivalent, Archives of Dermatology, March, 1998
13. Change Request 1521, January 22, 2001
14. C. Keith Bowering, MD, The Use of Dermagraft® in the Treatment of Diabetic Foot Ulcers "“FRCP
15. Richard A. Pollak, DPM, et. al., and the Dermagraft® Diabetic Ulcer Study Group, A Human Dermal Replacement for the Treatment of Diabetic Foot Ulcers -
16. Gary D. Genzkow, MD, et. al. Improved Healing of Diabetic Foot Ulcers after Grafting with a Living Human Dermal Replacement - - The Dermagraft® Diabetic Ulcer Study Group
17. A Metabolically Active Human Dermal Replacement for the Treatment of Diabetic Foot Ulcers- Gail Naughton, Jonathan Mansbridge, and Gary Gentzkow
18. Update of FDA, Humanitarian Device Exemption HDE - H020004
19. Marston, W. A., J. Hanft, et al. (2003). "The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers: Results of a prospective randomized trial." Diabetes Care 26(6): 1701-5.
20. Marston, W. A., Risk Factors Associated with Healing Chronic Diabetic Foot Ulcers: The Importance of Hyperglycemia Ostomy/Wound Management - ISSN: 0889-5899 - Volume 52 - Issue 3 - March 2006 - Pages: 26 - 39
21. FDA Approval Notice, dated March 1, 1996 (Integra); April 19, 2002
23. FDA Approval Notice, dated July 19, 2006 (Oasis).
24. CPT changes 2006, An Insider's View, November 2006
25. Molnar, Joseph A., et al; Acceleration of Integra Incorporation in Complex Tissue Defects with Subatmospheric Pressure, Plastic & Reconstructive Surgery, Vol. 113 No. 5, April 2004
26. The FDA Center for Biologics Evaluation & Research, Processing of Orthopedic, Cardiovascular & Skin Allografts Workshop, November 11, 2007. http://www.fda.gov/cber/minutes/allog101107t.pdf
27. Division of Medical Assistance Clinical Coverage Policy No.: 1G-2 Bioengineered Skin Original Effective Date: November 1, 2000 Revised Date: May 1, 2007. http://www.ncdhhs.gov/dma/physician/1G2.pdf
28. Ben-Bassat H. Performance and safety of skin allografts. Clinics in Dermatology. 2005;23:365-375.
29. Landsman A. Management of complex wounds with fresh cryopreserved human allografts. NAJMS. 2010;3(1):14-16.
30. Snyder RJ. Treatment of nonhealing ulcers with allografts. Clinics in Dermatology. 2005;23:388-395.
31. Spence RJ, Wong L. The enhancement of wound healing with human skin allograft. Surgical Clinics of North America. 1997;77(3):731-745.
Meeting Date:
Wisconsin 09/26/2008
Illinois 09/17/2008
Michigan 09/24/2008
Minnesota 09/11/2008
Iowa 10/16/2008
Kansas 10/16/2008
Missouri 10/17/2008
Nebraska 10/16/2008
Open Meeting Date
08/13/2008
This policy does not reflect the sole opinion of the contractor or the Contractor Medical Director(s). Although the final decision rests with the contractor, this policy was developed in cooperation with the Carrier Advisory Committee(s), which include representatives of various medical specialty societies.
Wisconsin 09/26/2008
Illinois 09/17/2008
Michigan 09/24/2008
Minnesota 09/11/2008
Iowa 10/16/2008
Kansas 10/16/2008
Missouri 10/17/2008
Nebraska 10/16/2008
Open Meeting Date
08/13/2008
This policy does not reflect the sole opinion of the contractor or the Contractor Medical Director(s). Although the final decision rests with the contractor, this policy was developed in cooperation with the Carrier Advisory Committee(s), which include representatives of various medical specialty societies.
Start Date of Comment Period
10/18/2008
End Date of Comment Period
12/03/2008
Start Date of Notice Period
01/01/2011
Revision History Number
X
Revision History Explanation
06/01/2010, a review
of the CMS data base revealed that ICD-9 codes 459.0, 459.12, 459.13
& 459.19 were added to this LCD in error at the time the LCD was
placed in CMS database they have been removed
04/13/2010 - CPT/HCPCS Codes Q4115 and Q4116 were originally omitted from list of NON-COVERED CPT/HCPCS Codes. Codes have now been to list of non-covered CPT/HCPCS Codes retroactively effective to original policy effective date.
*11/01/2009, three, removed typo information on HCPCS code Q4104, this has been and continues to be, as stated in matrix, a non-covered service, removed typo range (250.60-250.81) just under ICD-9 codes
09/01/2009, two, ICD-9 codes 250.82 and 252.83 inadvertently omitted from ICD-9-CM secondary diagnosis list. Effective 08/16/2009.
Removed contractor 05392 since it is being joined with WMO contractor number effective 08/01/2009
07/01/2009, one, this LCD replaces GSURG-037 and GSURG-537 and L28357;
04/15/2009 This draft was also known as DL 28721 which is being deleted since this updated draft version was posted. AB
04/19/2010-In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor Palmetto.
10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).
12/01/2010, four, added information regarding Q4110 Skin substitute, PriMatrix, use in POS office, CPT codes 15360 and 15361 not covered for Dermagraft®, J4 transition- removed Texas, Colorado, New Mexico and Oklahoma removed from list of legacy A states effective 10/18/2010
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:
11043 descriptor was changed in Group 1
11044 descriptor was changed in Group 1
15002 descriptor was changed in Group 1
15003 descriptor was changed in Group 1
15004 descriptor was changed in Group 1
15005 descriptor was changed in Group 1
15360 descriptor was changed in Group 1
15400 descriptor was changed in Group 1
15420 descriptor was changed in Group 1
Q4101 descriptor was changed in Group 1
Q4102 descriptor was changed in Group 1
Q4106 descriptor was changed in Group 1
Q4110 descriptor was changed in Group 1
Q4103 descriptor was changed in Group 2
Q4104 descriptor was changed in Group 2
Q4105 descriptor was changed in Group 2
Q4107 descriptor was changed in Group 2
Q4108 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
Q4116 descriptor was changed in Group 2
11/21/2010 - The following CPT/HCPCS codes were deleted:
Q4109 was deleted from Group 2
01/01/2011, five, 2011 CPT code update
02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).
12/01/2011, corrected typo changed word burn to wound,
11/21/2011 - The following CPT/HCPCS codes were deleted:
15340 was deleted from Group 1
15341 was deleted from Group 1
15360 was deleted from Group 1
15361 was deleted from Group 1
15365 was deleted from Group 1
15366 was deleted from Group 1
15400 was deleted from Group 1
15401 was deleted from Group 1
15420 was deleted from Group 1
15421 was deleted from Group 1
15430 was deleted from Group 1
15431 was deleted from Group 1
G0440 was deleted from Group 1
G0441 was deleted from Group 1
01/01/2012, Added as payable, TheraSkin®, 2012 HCPT code update, added CPT codes 15271-15278, deleted CPT codes 15340-15431 and G0440-G0441, removed references to codes;
01/01/2012, Added as payable, TheraSkin®, 2012 HCPT code update, added CPT codes 15271-15278, deleted CPT codes 15340-15431 and G0440-G0441, removed references to thesecodes, added to list of non-covered codes HCPCS Q4122-Q4130;
02/01/2012, Removed information regarding MPFSDB
03/01/2012, ICD-9 codes 459.13, 459.31, 459.33 were added to this LCD in error - they have been removed
04/01/2012, Clarified POS instructions to the skin graft codes
05/01/2012, Added coverage of HCPCS code Q4107 claims submitted with dates of service on and after 5/1/2012;
04/13/2010 - CPT/HCPCS Codes Q4115 and Q4116 were originally omitted from list of NON-COVERED CPT/HCPCS Codes. Codes have now been to list of non-covered CPT/HCPCS Codes retroactively effective to original policy effective date.
*11/01/2009, three, removed typo information on HCPCS code Q4104, this has been and continues to be, as stated in matrix, a non-covered service, removed typo range (250.60-250.81) just under ICD-9 codes
09/01/2009, two, ICD-9 codes 250.82 and 252.83 inadvertently omitted from ICD-9-CM secondary diagnosis list. Effective 08/16/2009.
Removed contractor 05392 since it is being joined with WMO contractor number effective 08/01/2009
07/01/2009, one, this LCD replaces GSURG-037 and GSURG-537 and L28357;
04/15/2009 This draft was also known as DL 28721 which is being deleted since this updated draft version was posted. AB
04/19/2010-In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor Palmetto.
10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).
12/01/2010, four, added information regarding Q4110 Skin substitute, PriMatrix, use in POS office, CPT codes 15360 and 15361 not covered for Dermagraft®, J4 transition- removed Texas, Colorado, New Mexico and Oklahoma removed from list of legacy A states effective 10/18/2010
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:
11043 descriptor was changed in Group 1
11044 descriptor was changed in Group 1
15002 descriptor was changed in Group 1
15003 descriptor was changed in Group 1
15004 descriptor was changed in Group 1
15005 descriptor was changed in Group 1
15360 descriptor was changed in Group 1
15400 descriptor was changed in Group 1
15420 descriptor was changed in Group 1
Q4101 descriptor was changed in Group 1
Q4102 descriptor was changed in Group 1
Q4106 descriptor was changed in Group 1
Q4110 descriptor was changed in Group 1
Q4103 descriptor was changed in Group 2
Q4104 descriptor was changed in Group 2
Q4105 descriptor was changed in Group 2
Q4107 descriptor was changed in Group 2
Q4108 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
Q4116 descriptor was changed in Group 2
11/21/2010 - The following CPT/HCPCS codes were deleted:
Q4109 was deleted from Group 2
01/01/2011, five, 2011 CPT code update
02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).
12/01/2011, corrected typo changed word burn to wound,
11/21/2011 - The following CPT/HCPCS codes were deleted:
15340 was deleted from Group 1
15341 was deleted from Group 1
15360 was deleted from Group 1
15361 was deleted from Group 1
15365 was deleted from Group 1
15366 was deleted from Group 1
15400 was deleted from Group 1
15401 was deleted from Group 1
15420 was deleted from Group 1
15421 was deleted from Group 1
15430 was deleted from Group 1
15431 was deleted from Group 1
G0440 was deleted from Group 1
G0441 was deleted from Group 1
01/01/2012, Added as payable, TheraSkin®, 2012 HCPT code update, added CPT codes 15271-15278, deleted CPT codes 15340-15431 and G0440-G0441, removed references to codes;
01/01/2012, Added as payable, TheraSkin®, 2012 HCPT code update, added CPT codes 15271-15278, deleted CPT codes 15340-15431 and G0440-G0441, removed references to thesecodes, added to list of non-covered codes HCPCS Q4122-Q4130;
02/01/2012, Removed information regarding MPFSDB
03/01/2012, ICD-9 codes 459.13, 459.31, 459.33 were added to this LCD in error - they have been removed
04/01/2012, Clarified POS instructions to the skin graft codes
05/01/2012, Added coverage of HCPCS code Q4107 claims submitted with dates of service on and after 5/1/2012;
Reason for Change
Other
Related Documents
This LCD has no Related Documents.
LCD Attachments
Billing & Coding Guidelines 5/1/12 (PDF - 20 KB)
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Page Last Updated: Thursday, 03-May-2012 11:44:26 CDT
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