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Bio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), nonhuman tissue (xenographic), synthetic materials, or a composite of these materials. Bioengineered skin and soft tissue substitutes are being evaluated for a variety of conditions, including breast reconstruction and to aid healing of lower-extremity ulcers and severe burns. Acellular dermal matrix products are also being evaluated in the repair of a variety of soft tissues.
Bio-engineered skin and soft tissue substitutes may be either acellular or cellular. Acellular products (ie, cadaveric human dermis with cellular material removed) contain a matrix or scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin. Cellular products contain living cells such as fibroblasts and keratinocytes within a matrix. The cells contained within the matrix may be autologous, allogeneic, or derived from other species (eg, bovine, porcine). Skin substitutes may also be composed of dermal cells, epidermal cells, or a combination of dermal and epidermal cells, and may provide growth factors to stimulate healing. Tissue-engineered skin substitutes can be used as either temporary or permanent wound coverings. There are a large number of potential applications for artificial skin and soft tissue products. One large category is nonhealing wounds, which potentially encompasses diabetic neuropathic ulcers, vascular insufficiency ulcers, and pressure ulcers. A substantial minority of such wounds do not heal adequately with standard wound care, leading to prolonged morbidity and increased risk of mortality. For example, nonhealing lower-extremity wounds represent an ongoing risk for infection, sepsis, limb amputation, and death. Bio-engineered skin and soft tissue substitutes have the potential to improve rates of healing and reduce secondary complications.
Other situations in which bio-engineered skin products might substitute for living skin grafts include certain postsurgical states such as breast reconstruction, in which skin coverage is inadequate for the procedure performed, or for surgical wounds in patients with compromised ability to heal. Second- and third-degree burns are another situation in which artificial skin products may substitute for auto- or allografts. Certain primary dermatologic conditions that involve large areas of skin breakdown, such as bullous diseases, may also be conditions in which artificial skin products can be considered as substitutes for skin grafts. Acellular dermal matrix (ADM) products are also being evaluated in the repair of other soft tissues including rotator cuff repair, following oral and facial surgery, hernias, and a variety of other conditions.
Breast reconstructive surgery using allogeneic acellular dermal matrix products* (ie, AlloDerm®, AlloMax™, DermaMatrix™, FlexHD®, GraftJacket®) may be considered medically necessary,
Treatment of chronic, noninfected, full-thickness diabetic lower-extremity ulcers using the following tissueengineered skin substitutes may be considered medically necessary:
Treatment of chronic, noninfected, partial- or full-thickness lower-extremity skin ulcers due to venous insufficiency, which have not adequately responded following a 1-month period of conventional ulcer therapy, using the following tissue-engineered skin substitutes may be considered medically necessary:
Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:
All other uses of the bio-engineered skin and soft tissue substitutes listed above are considered investigational.
All other skin and soft tissue substitutes not listed above are considered investigational, including, but not limited to:
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/2001: Approved by Medical Policy Advisory Committee (MPAC)
4/10/2002: Code Reference section updated, HCPCS J7340 added
4/18/2002: Type of Service and Place of Service deleted
5/30/2002: Code Reference section updated, ICD-9 280.82, 459.81, 459.89, 707.0, 707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19, 707.8, 707.9, 891.0, 891.1, 891.2, 892.0, 892.1, 892.2, 893.0, 893.1, 893.2, 894.0, 894.1, 894.2 added
8/1/2003: ICD-9 diagnosis code 433.9 typo corrected, ICD-9 diagnosis code ranges 443.0-443.9, 707.0-707.9, 891.0-894.2 listed separately
2/12/2004: Code Reference section updated; ICD-9 diagnosis code 443.0, 443.1, 443.21, 443.22, 443.23, 443.24, 443.29, 443.81, 443.89, 443.9 deleted; HCPCS C1305, Q0185 deleted
3/22/2005: Code Reference section updated, ICD-9 diagnosis code 707.0 5th digit with effective date of 10/1/2004 added, HCPCS J7343 with effective date of 1/1/2005 added
8/1/2005: Code Reference section updated, CPT 15342, 15343 added, ICD-9 diagnosis code 250.80, 250.81 with note "use additional code to identify any associated ulceration (i.e., 707.10-707.9)" added, ICD-9 diagnosis 707.10-707.9 description revised, ICD-9 diagnosis code 891.0, 891.1, 891.2, 892.0, 892.1, 892.2, 893.0, 893.1, 893.2, 894.0, 894.1, 894.2 deleted
03/08/2006: Coding updated. CPT/HCPCS 2006 revisions added to policy
11/16/2006: Policy updated. Updates approved by Medical Policy Advisory Committee (MPAC). Added ICD-9 code 756.81
12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions
5/14/07: Policy reviewed, no changes
12/17/07: Coding updated. CPT/HCPCS 2008 revisions added to policy.
9/3/2008: Added ICD-9 codes 250.60 - 250.63
9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied
12/24/2008: Code reference section updated per 2009 CPT/HCPCS revisions
6/30/2009: New HCPC codes Q4115 and Q4116 added to covered table.
03/09/2011: Removed the following deleted codes from the Code Reference section: 15342, 15343, J7340, J7343, J7345 - J7349.
04/24/2013: Policy reviewed; no changes.
11/03/2014: Policy title changed from "Apligraf for Wound Healing" to "Bio-Engineered Skin and Soft Tissue Substitutes." Policy description updated to reflect scope of policy. Policy statement udpated to list medically necessary products and their covered indications, as well as the products that are considered investigational.
12/31/2014: Added the following new 2015 HCPCS codes to the Code Reference section: Q4150, Q4151, Q4152, Q4153, Q4154, Q4155, Q4156, Q4157, Q4158, Q4159, and Q4160.
04/30/2015: Policy statement revised to add that EpiFix is considered medically necessary for treatment of diabetic foot ulcers. Updated listing of investigational skin and soft tissue substitutes in the policy statement. Policy guidelines updated to add medically necessary and investigational definitions. Code Reference section updated to add CPT Codes 15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278 to the Covered Codes table. Added HCPCS codes Q4128 and Q4131 to the Covered Codes table. Removed deleted procedure codes Q4109, 15170, 15171, 15175, 15176, 15340, 15341, 15360, 15361, 15365, and 15366 from the Code Reference section. HCPCS codes Q4103, Q4104, Q4108, Q4110, Q4111, and Q4115 moved to the Investigational Codes section and also added HCPCS codes Q4112 - Q4114, and Q4117 - Q4127, and Q4129 - Q4149 to the Investigational Codes table per the investigational policy statement. Added ICD-9 diagnosis codes 174.0 - 174.9, 233.0, 941.30 - 941.39, 941.40 - 941.49, 941.50 - 941.59, 942.30 - 942.39, 942.40 - 942.49, 942.50 - 942.59, 943.30 - 943.39, 943.40 - 943.49, 943.50 - 943.59, 944.30 - 944.38, 944.40 - 944.48, 944.50 - 944.58, 945.30 - 945.39, 945.40 - 945.49, 945.50 - 945.59, 946.3 - 946.5, 948.00 - 948.99, 949.3 - 949.5, V10.3, and V45.71 to the Covered Codes table. Removed diagnosis code 756.81 from the Covered Codes table. Deleted outdated references from the Sources section.
08/31/2015: Medical policy revised to add ICD-10 codes.
12/31/2015: Code Reference section updated to add new 2016 HCPCS codes Q4161, Q4162, Q4163, Q4164, and Q4165 to the investigational codes table. Code description revised for HCPCS code Q4153.
Blue Cross Blue Shield Association policy # 7.01.113
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.