Bioengineered Skin Substitutes – cpt 15330, 15430,c9363,g0440,q4100

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The provisions of this LCD apply to payment for bioengineered skin substitutes and the physician services reported for wound preparation and material application to chronic wounds. This LCD does not address human skin autografts, cadaveric human skin allografts, or dermal xenografts (porcine). Additionally, the provisions of this LCD do not apply to treatment of acute wounds, tendon and/or ligament augmentation/repair, postoperative wounds, or burns.
The following general indications and limitations to Medicare coverage and payment apply to all bioengineered skin substitutes and physician services related to skin substitute application.
Indications – all covered bioengineered skin substitutes 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 to wounds that have demonstrated a failed or insufficient response to no fewer than four weeks of conservative wound-care measures when applied to chronic wounds. For initial applications of skin substitutes/replacements, a “failed response” to conservative measures is defined as an ulcer that has increased in size or depth or for which there has less than 30% closure from baseline For purposes of this LCD, conservative measures include, but are not limited to:
    • Elimination of underlying cellulitis, osteomyelitis or other infection.
    • Elimination of edema.
    • Appropriate debridement of necrotic tissue.
    • Appropriate non-weight bearing and/or other means for off-loading pressure.
    • Provision of appropriate wound environment to promote healing.
  • Provided in association with patient care (including home care by patient or other entity) that is consistent with all other accepted standards of medical/surgical wound management (including appropriate physician evaluation/management and supervision of care provided by non-physicians).
  • Applied to wounds reasonably expected to heal in the presence of the wound environment, cytokines and growth factors supplied by the skin substitute/replacement and not applied to wounds demonstrating such hostile host environment that destruction of the substitute is highly likely.
  • Applied to wounds that are clean and free of infection.
  • Applied to wounds of reasonable size given the clinical circumstances. For instance, Medicare would not expect routine use of graft material in treating small wounds (smaller than 1.0 cm2 or 1cm in smallest diameter) unless the medical record clearly demonstrates the wound to be refractory to conservative treatment but otherwise healable. Use on small wounds that have demonstrated adequate healing by conservative means is not covered.
  • Only applied to wounds with adequate circulation/oxygenation to support tissue growth/wound healing as evidenced by physical examination (presence of acceptable peripheral pulses and/or Doppler toe signals and/or Ankle-Brachial Index (ABI) of no less than 0.65).
Limitations:
Timing, frequency and number of reapplications of bioengineered skin substitutes should be appropriate for the material used and clinical condition of the patient. Medicare does not expect to see routine application of maximally allowed numbers of skin substitutes/replacements per wound and will monitor and evaluate claim data regarding numbers of applications per patient and per wound.
During a course of treatment, repeat applications of skin substitutes/replacements are not indicated when applications heretofore were unsuccessful. Unsuccessful treatment is defined in this situation as increase in size or depth of a wound or ulcer, or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation or epithelialization and no progress toward closing) since the previous application.
Retreatment of healed ulcers is not indicated. Retreatment with the same skin substitute product is not indicated for ulcers for which an initial course of treatment with skin substitutes was unsuccessful. An unsuccessful course of treatment is defined in this case as incomplete healing following maximal numbers of applications and/or maximal duration of treatment time indicated by the FDA label of the individual product and/or this LCD.
Skin substitutes/replacements must not be provided to patients with known hypersensitivity to any component of the specific skin substitute/replacement material, inadequate control of underlying condition or exacerbating factors, or other contraindication (e.g., allergy to bovine or porcine collagen, uncontrolled diabetes, active infection, active charcoarthropathy of the ulcer extremity, vasculitis, uncontrolled rheumatoid arthritis or rheumatoid ulcers, radiation and/or chemotherapy within one month immediately preceding application of skin substitute/replacement, ongoing use of high-dose corticosteroids or immunosuppressants).
Note: Medicare may make payment only for those services performed by persons with appropriate education, knowledge, skill and competence. Medicare may make payment for physician services performed by persons licensed by the state to perform them. Because applications of Apligraf®, Oasis®, GraftJacket® and Dermagraft®, as well as any subsequently accepted similar product, are physician (surgical) services, Medicare payment for the products and their applications will be made only to licensed physicians and qualified non-physician practitioners who are licensed to perform these physician services (nurse practitioners, clinical nurse specialists and physician assistants). However, payment for major surgical procedures remains restricted to physicians only (in this case, “physicians” refers to MD, DO and DPM physicians).
Bioengineered skin substitutes not coded as Q4101, Q4102, Q4106 and Q4107, are non-covered. Non-covered products include the following:
  • Integra™ Bilayer Matrix Wound Dressing (C9363, Q4104), Integra™ Wound Dressing Matrix (Q4108), Integra™Dermal Regeneration Template (Q4105), and Integra™ Flowable Wound Matrix (Q4114).
  • GraftJacket Xpress® (Q4113).
  • Primatrix™ (Q4110).
  • Cymetra (Q4112).
  • AlloDerm® Regenerative Tissue Matrix (Q4116).
  • Skin substitute, endoform dermal template, per square centimeter (C9367).
  • Theraskin, per square centimeter (Q4121).
For codes Q4118–Q4120, refer to the related article for limitation description.
The following indications and limitations to Medicare coverage and payment apply to the specified bioengineered skin substitutes and their related skin substitute application physician services.
Apligraf® (Q4101) Indications:
  • Neuropathic diabetic foot ulcer.
  • Venous stasis ulcer.
Apligraf® (Q4101) Limitations:
  • Medicare payment for Apligraf® is limited to five applications per ulcer, though more than three applications ofApligraf® to a single wound are usually unnecessary.
  • Medicare does not cover continued reapplication of Apligraf® when the treatment is unsuccessful after 30 days of treatment.
  • Medicare does not cover retreatment of an ulcer following an unsuccessful course of treatment.
  • Medicare does not cover retreatment of a successfully treated, healed ulcer.
Oasis® (Q4102) Indications:
  • Neuropathic diabetic foot ulcer.
  • Venous stasis ulcer.
Oasis® (Q4102) Limitations:
  • Medicare payment for Oasis® is limited to 12 weeks of therapy per ulcer.
  • Medicare does not cover continued reapplication of Oasis® when the treatment is unsuccessful after 30 days of treatment.
  • Medicare does not cover retreatment of an ulcer following an unsuccessful course of treatment.
  • Medicare does not cover retreatment of a successfully treated, healed ulcer.
Dermagraft® (Q4106) Indications:
  • Treatment of full-thickness diabetic foot ulcers.
Dermagraft® (Q4106) Limitations:
  • Studies have documented that, for Q4106, survival of the dermal substitute decreases significantly when the 24 steps noted in the FDA labeling are not followed, therefore the 24 steps must be followed and documented.
  • Frequency is limited to eight applications per ulcer.
  • Medicare does not cover continued reapplication of Dermagraft® when the treatment is unsuccessful after 30 days of treatment.
  • Medicare does not cover continued reapplication of Dermagraft® for the same ulcer if satisfactory and reasonable healing progress is not noted after 12 weeks of therapy.
  • Medicare does not cover retreatment of the same ulcer using Dermagraft® following an unsuccessful course of treatment.
  • Medicare does not cover retreatment of a successfully treated, healed ulcer.
GraftJacket® (Q4107) Indications:
  • Full-thickness diabetic foot ulcers
GraftJacket® (Q4107) Limitations:
  • Medicare payment for GraftJacket® is limited to 1 application per ulcer.
  • Medicare does not cover retreatment of an ulcer following an unsuccessful course of treatment.
  • Medicare does not cover retreatment of a successfully treated, healed ulcer.
Surgical Wound Preparation (CPT codes 15002–15005)
CPT codes 15002–15005 are used to report open wound or burn eschar/scar excision as preparation for graft implantation. Wound cleansing, debridement, removal of exudates, debris, eschars, granulation tissue and other non-excisional wound preparation are considered to be part of the skin substitute material application procedure (CPT codes 15330-15431). Medicare does not expect to be billed for CPT codes 15002–15005 in conjunction with routine, simple and/or repeat application of skin substitutes/replacements.
Skin Substitute Application Procedures (CPT codes 15330-15431 and G0440-G0441)
AMA CPT and AMA CPT Assistant (October, 2006) indicate that CPT codes 15330–15431 and G0440-G0441 are not used to report simple application of the skin substitute material or application of the material stabilized only with dressings.
The CPT procedure codes listed in this policy describe and are to be used to report skin grafts using bioengineered skin substitutes. Do not report any CPT procedure code listed in this policy when using a bioengineered skin substitute as an implanted or prosthetic material or otherwise used not as an application to skin and surrounding tissues (e.g., material used for non-skin applications such as tendon augmentation, breast reconstruction, ventral and incisional hernia repair, etc).
Skin graft procedures using bioengineered skin substitutes in which skin substitutes are appropriately handled, appliedand immobilized (whether by sutures, staples, Steri-Strips™ or by other appropriate technique as per manufacturer’s label or packaging instruction) should be reported using the appropriate graft procedure code and/or with the product itself using the KX modifier.
It is the surgeon’s decision as to fixation method/device for bioengineered skin substitutes. However, because survival of the substitute material is jeopardized by inadequate handling, application and immobilization of the material, Medicare considers all skin substitute products and their application procedures otherwise performed to be not medically necessary and not covered.
Skin substitute products and their application procedures not meeting all of the provisions of this policy are not payable by Medicare and must be reported without the KX modifier.
See “Coding Guidelines” regarding required use of the KX modifier with Q4101, Q4102, Q4106, Q4107 and 15330–15431 and G0440-G0441 to report skin substitute products that have been handled, applied and immobilized appropriately and according to manufacturers’ label instructions.
See “Coding Guidelines” in the associated LCD article for instructions regarding use of modifiers JC and JD when reporting bioengineered skin substitutes materials.
Product Wastage
Medicare provides payment for the amount of the bioengineered skin substitute product that is reasonable and necessary to treat the patient’s wound. If the physician has made good faith efforts to minimize the unused portion of the bioengineered skin substitute product in how patients are scheduled and how he ordered, accepted, stored and used the product and made good faith efforts to minimize the unused portion of the product in how it is supplied, the program will cover the amount of product discarded along with the amount used to treat the wound. Documentation requirements for unused/discarded materials are given below. Discarded materials must be reported separately from the medically necessary material used to treat a wound. Coding and billing instructions for discarded materials are referenced in the attached article. Coding and billing instructions can be referenced in the attached article. Refer to national policy: Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.
Medicare will monitor and evaluate claim data related to discarded materials. Seeking additional payment from Medicare (by reporting on a separate claim materials previously reported as discarded) for wasted/discarded material constitutes a false claim – a felony crime punishable under federal law.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
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.
13X, 18X, 21X, 22X, 83X, 85X
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Pub. 100-04, Claims Processing Manual, for further guidance.
0360, 0361, 0450, 0456, 0490, 051X, 0520, 0521, 0522, 0523, 0526, 0529, 0636, 0761
CPT/HCPCS Codes
Note:
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
15330©
Aply acell alogrft t/arm/leg
15331©
Aply acell grft t/a/l add-on
15335©
Apply acell graft, f/n/hf/g
15336©
Aply acell grft f/n/hf/g add
15340©
Apply cult skin substitute
15341©
Apply cult skin sub add-on
15360©
Apply cult derm sub, t/a/l
15361©
Aply cult derm sub t/a/l add
15365©
Apply cult derm sub f/n/hf/g
15366©
Apply cult derm f/hf/g add
15430©
Apply acellular xenograft
15431©
Apply acellular xgraft add
C9363
Skin substitute, Integra Meshed Bilayer Wound Matrix, per square centimeter (ASC and OPPS only)
C9367
Apply acell graft f/n/hf/g
G0440
Application of tissue cultured allogeneic skin substitute or dermal substitute, first 25 sq cm or less
G0441
Application of tissue cultured allogeneic skin substitute or dermal substitute, each additional 25 sq cm
Q4100
Skin substitute, not otherwise specified
Q4101
Apligraf, per square centimeter
Q4102
Oasis Wound Matrix, per square centimeter
Q4104
Integra Bilayer Matrix Wound Dressing (BMWD), per square centimeter
Q4105
Integra Dermal Regeneration Template (DRT), per square centimeter
Q4106
Dermagraft, per square centimeter
Q4107
Graftjacket, per square centimeter
Q4108
Integra Matrix, per square centimeter
Q4110
Primatrix, per square centimeter
Q4112
Cymetra, injectable, 1cc
Q4113
Graftjacket Express, injectable, 1cc
Q4114
Integra Flowable Wound Matrix, injectable, 1cc
Q4116
Alloderm, per square centimeter
Q4118
Matristem micromatrix, 1 mg
Q4119
Matristem wound matrix, per sq centimeter
Q4120
Matristem burn matrix, per sq centimeter
Q4121
Theraskin, per sq centimeter
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for Q4101 used to report Apligraf® and Q4102 used to report Oasis®:
Covered for:
250.60*-250.63*
Diabetes with neurological manifestations
250.80*–250.83*
Diabetes with other specified manifestations
Note: For coding neuropathic diabetic ulcers, use of two codes (dual diagnosis) is necessary. Code the ulcer as the primary diagnosis (707.12*–707.15*) and use 250.60*-250.63* or 250.80*–250.83* to indicate diabetes with ulcer or neurologic manifestations as a secondary diagnosis.
454.0
Varicose veins of lower extremities with ulcer
454.2
Varicose veins of lower extremities with ulcer and inflammation
459.31
Chronic venous hypertension with ulcer
459.33
Chronic venous hypertension with ulcer and inflammation
707.12*–707.15*
Ulcer of lower limb, except decubitus
Note: For coding neuropathic diabetic ulcers, use of two codes (dual diagnosis) is necessary. Code the ulcer as the primary diagnosis (707.12*–707.15*) and use 250.60*-250.63* or 250.80*–250.83* to indicate diabetes with ulcer or neurologic manifestations as a secondary diagnosis.
*Note: Dual diagnosis requirement for coding neuropathic diabetic ulcers. Code the ulcer as the primary diagnosis. Code diabetes with neurologic manifestations as the secondary diagnosis.
Medicare is establishing the following limited coverage dual-diagnosis requirement for Q4106 used to reportDermagraft® and Q4107 used to report GraftJacket®:
Covered for:
Primary Diagnosis Codes:
707.13*–707.15*
Ulcer of lower limb, except decubitus
Secondary Diagnosis Codes:
250.60*-250.63*
Diabetes with neurological manifestations
250.80*–250.83*
Diabetes with other specified manifestations
* Note: For coding neuropathic diabetic ulcers, use of two codes (dual diagnosis) is necessary. Code the ulcer as the primary diagnosis (707.13*–707.15*) and use 250.60*-250.63* or 250.80*–250.83* to indicate diabetes with ulcer or neurologic manifestations as a secondary diagnosis.
Specific limited coverage (diagnosis to procedure criteria) is not being established for the remaining covered CPT/HCPCS codes included in this LCD. However, payment for all bioengineered skin substitute and related services codified by the covered product and procedure codes included in this LCD is restricted to coverage as outlined in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD.
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
N/A
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD including, but not limited to the following:
  • Infected ulcer.
  • Osteomyelitis.
  • Allergy to bovine collagen.
  • Uncontrolled diabetes (“controlled” diabetes for purposes of this LCD would be based on documentation in the medical record).
  • Active Charcot arthropathy of the ulcer extremity.
  • Vasculitis.
  • Uncontrolled rheumatoid arthritis and/or rheumatoid ulcers.
  • Other uncontrolled collagen vascular disease.
  • Patients being treated with high-dose corticosteroids or immunosuppressants.
  • Patients who have undergone radiation and/or chemotherapy within the month immediately preceding proposed bioengineered skin substitute application.
Documentation Requirements
  • Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
  • Medical record documentation must confirm and support that all requirements set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD have been satisfied with regard to the clinical characteristics of the ulcer, the presence of qualifying or disqualifying conditions, and the nature of and the duration of pretreatment conservative/conventional management.
  • The exact location of each ulcer treated must be included in the medical record.
  • Documentation of response, or lack thereof, to conservative therapy requires documentation of the measurements (depth, width and length or circumference) of the ulcer at initial presentation and following conservative or conventional management to be included in the medical record.
  • Documentation must include measurement (width and length or circumference and depth) of the ulcer immediately prior to all applications of skin substitutes/replacements.
  • The record must document that wound treatments with bioengineered skin substitutes are accompanied by appropriate adjunctive wound care measures such as dressing changes during the healing period, appropriate compressive dressings, appropriate off-loading, etc.
  • Documentation must show that the skin substitute product was appropriately handled, applied, and immobilized (for example, for Q4106, that the 24 steps noted in the FDA labeling for Q4106 were followed) in accordance with manufacturer’s label instructions.
  • Medical record documentation must clearly document the medical necessity of, performance of and the extent of site preparation procedures reported with bioengineered skin substitute application services.
Product Wastage Documentation Requirements
Any amount of wasted material must be clearly documented in the medical record with the following information:
  • Date, time and location of ulcer treated.
  • Approximate amount of product unit used.
  • Approximate amount of product unit discarded.
  • Reason for the wastage.
  • Manufacturer’s serial/lot/batch or other unit identification number of graft material. When manufacturer does not supply unit identification, record must document such.