mp-527
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Bio-Engineered Skin and Soft Tissue Substitutes

Policy Number: MP-527

Latest Review Date:  January 2022

Category: Surgery                                                                  

POLICY:

Covered

Effective dates of service on and after February 5, 2021:

Treatment of upper and lower eyelid retraction or conjunctival contraction requiring soft tissue spacer or replacement using the following tissue-engineered skin substitute may be considered medically necessary:

  • AlloDerm®

Breast reconstructive surgery using the allogenic acellular dermal matrix products* AlloDerm®, Cortiva (AlloMax™), AlloMend®, DermACELL™, DermaMatrix™, FlexHD®, FlexHD® Pliable, GraftJacket® may be considered medically necessary:

  • When there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required; OR
  • When there is viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or necrosis; OR
  • The infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-establishment of these landmarks is needed.

Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers using the following tissue-engineered skin substitutes may be considered medically necessary:

  • AlloPatch®
  • Apligraf®**
  • Dermagraft®**
  • Integra® Omnigraft Dermal Regeneration Matrix (also known as Omnigraft) and Integra Flowable Wound Matrix

Treatment of chronic, non-infected, partial- or full-thickness lower extremity skin ulcers due to venous insufficiency, which have not adequately responded following a one-month period of conventional ulcer therapy, using the following tissue-engineered skin may be considered medically necessary:

  • Apligraf®**
  • Oasis™ Wound Matrix***

Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitute may be considered medically necessary:

  • OrCel™ (for the treatment of mitten-hand deformity when standard wound therapy has failed and when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the FDA)****

Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:

  • Epicel® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30% when provided in accordance with the HDE specifications of the FDA)****
  • Integra Dermal Regeneration Template™**

*Banked Human Tissue

** FDA PMA approved

*** FDA 510(k) cleared

**** FDA-approved under a humanitarian device exemption (HDE)

Non-Covered

All other uses of the bio-engineered skin and soft tissue substitutes listed above are considered investigational.

Bio-Engineered Skin and Soft Tissue Substitutes for use in surgical repair of complex abdominal wall wounds (e.g., fascial defect, hernia repair, infection, etc.) are considered investigational. 

All other skin and soft tissue substitutes not listed above are considered investigational, including, but not limited to:

  • ACell® UBM Hydated Wound Dressing
  • ACell® UBM Lyophilized Wound Dressing
  • AlloSkin™
  • AlloSkin™ RT
  • Aongen™ Collagen Matrix
  • Architect Extracellular Matrix
  • ArthroFlex™ (FlexGraft)
  • Avance® nerve graft
  • Axoguard® nerve connector
  • AxoGuard® Nerve Protector (AxoGen)
  • Biobrane®
  • Bio-Connekt® Wound Matrix
  • BioRenew
  • BioSkin
  • CollaCare®
  • CollaCare® Dental
  • Collagen Sponge (Innocoll)
  • Collagen Wound Dressing (Oasis Research)
  • CollaGuard®
  • CollaMend™
  • CollaSorb™
  • CollaWound™
  • Coll-e-derm
  • Collexa®
  • Collieva®
  • Conexa™
  • Coreleader Colla-Pad
  • CorMatrix®
  • Cymetra®
  • Cytal™ (previously MatriStem)
  • Dermacell
  • Dermadapt™ Wound Dressing
  • Derma-gide
  • DermaPure™
  • DermaSpan™
  • DressSkin
  • Durepair Regeneration Matrix®
  • Endoform Dermal Template™
  • ENDURAgen™
  • Excellagen
  • ExpressGraft™
  • E-Z Derm™
  • Flexigraft®
  • FlowerDerm™
  • GammaGraft
  • Geistlich Derma-Gide™
  • GraftJacket® Xpress, injectable
  • HA Absorbent Wound Dressing
  • Helicoll™
  • hMatrix®
  • Hyalomatrix® (Laserskin®)
  • Hyalomatrix® PA
  • Integra® Matrix Wound Dressing (previously Avagen)
  • Integra™ Bilayer Wound Matrix
  • InteguPly®
  • Jaloskin®
  • Keramatrix®
  • Kerecis™
  • Keroxx™
  • MariGen™/Kerecis™ Omega3™
  • MatriDerm®
  • MatriStem
  • Matrix Collagen Wound Dressing
  • Matrix HD™
  • MediHoney®
  • Mediskin®
  • MemoDerm™
  • MicroMatrix®
  • Miroderm®
  • Miroderm® Biologic Wound Matrix
  • MyOwn skin
  • NeuraGen® nerve guide
  • NeuraWrap™ nerve protector
  • Neuroflex™ collagen conduit
  • NeuroMatrix™ collegen conduit
  • NeuroMend™ collagen wrap
  • Oasis® Burn Matrix
  • Oasis® Ultra Tri-Layer Matrix
  • Ologen™ Collagen Matrix
  • Omega3 Wound (originally Merigen wound dressing)
  • Permacol™
  • PriMatrix™
  • Primatrix™ Dermal Repair Scaffold
  • Progenamatrix
  • Puracol® and Puracol® Plus Collagen Wound Dressings
  • PuraPly™ AM (Antimicrobial Wound Matrix)
  • PuraPly™ wound Matrix (previously FortaDerm™)
  • Puros® Dermis
  • RegenePro™
  • Repliform®
  • Repriza™
  • SkinTE™
  • StrataGraft
  • Strattice™
  • Suprathel®
  • SurgiMend®
  • Talymed®
  • TenoGlide™
  • TenSIX
  • TheraForm™ Standard/Sheet
  • TheraSkin®
  • TissueMend
  • TruSkin™
  • Veritas® Collagen Matrix
  • WoundEx
  • XCM Biologic Tissue Matrix7
  • XenMatrix™ AB

Note:

For additional information on specific ocular conditions using amniotic products, refer to medical policy #624 Amniotic Membrane Transplantation for the Ocular Surface.

For additional information on all other amniotic products and indications for use, refer to medical policy #597 Amniotic Membrane and Amniotic Fluid.

Effective for dates of service on or after January 23, 2020 and prior to February 5, 2021:

Covered

Treatment of upper and lower eyelid retraction or conjunctival contraction requiring soft tissue spacer or replacement using the following tissue-engineered skin substitute may be considered medically necessary:

  • AlloDerm®

Breast reconstructive surgery using the allogenic acellular dermal matrix products* AlloDerm®, Cortiva (AlloMax™), AlloMend®, DermACELL™, DermaMatrix™, FlexHD®, FlexHD® Pliable, GraftJacket® may be considered medically necessary:

  • When there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required; OR
  • When there is viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or necrosis; OR
  • The infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-establishment of these landmarks is needed.

Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers using the following tissue-engineered skin substitutes may be considered medically necessary:

  • AlloPatch®
  • Apligraf®**
  • Dermagraft®**
  • Integra® Omnigraft Dermal Regeneration Matrix (also known as Omnigraft) and Integra Flowable Wound Matrix

Treatment of chronic, non-infected, partial- or full-thickness lower extremity skin ulcers due to venous insufficiency, which have not adequately responded following a one-month period of conventional ulcer therapy, using the following tissue-engineered skin may be considered medically necessary:

  • Apligraf®**
  • Oasis™ Wound Matrix***

Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitute may be considered medically necessary:

  • OrCel™ (for the treatment of mitten-hand deformity when standard wound therapy has failed and when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the FDA)****

Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:

  • Epicel® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30% when provided in accordance with the HDE specifications of the FDA)****
  • Integra Dermal Regeneration Template™**

*Banked Human Tissue

** FDA PMA approved

*** FDA 510(k) cleared

**** FDA-approved under a humanitarian device exemption (HDE)

Non-Covered

All other uses of the bio-engineered skin and soft tissue substitutes listed above are considered not medically necessary and investigational.

All other skin and soft tissue substitutes not listed above are considered not medically necessary and investigational, including, but not limited to:

  • ACell® UBM Hydated Wound Dressing
  • ACell® UBM Lyophilized Wound Dressing
  • AlloSkin™
  • AlloSkin™ RT
  • Aongen™ Collagen Matrix
  • Architect Extracellular Matrix
  • ArthroFlex™ (FlexGraft)
  • Atlas Wound Matrix
  • Avagen Wound Dressing
  • AxoGuard® Nerve Protector (AxoGen)
  • Biobrane®
  • Bio-Connekt® Wound Matrix
  • BioRenew
  • BioSkin
  • CollaCare®
  • CollaCare® Dental
  • Collagen Sponge (Innocoll)
  • Collagen Wound Dressing (Oasis Research)
  • CollaGuard®
  • CollaMend™
  • CollaSorb™
  • CollaWound™
  • Collexa®
  • Collieva®
  • Conexa™
  • Coreleader Colla-Pad
  • CorMatrix®
  • Cymetra®
  • Cytal™ (previously MatriStem)
  • Dermacell
  • Dermadapt™ Wound Dressing
  • DermaPure™
  • DermaSpan™
  • DressSkin
  • Durepair Regeneration Matrix®
  • Endoform Dermal Template™
  • ENDURAgen™
  • Excellagen
  • ExpressGraft™
  • FlowerDerm™
  • Flexigraft®
  • GammaGraft
  • GraftJacket® Xpress, injectable
  • HA Absorbent Wound Dressing
  • Helicoll™
  • Hyalomatrix® (Laserskin®)
  • Hyalomatrix® PA
  • hMatrix®
  • Integra™ Bilayer Wound Matrix
  • Jaloskin®
  • Keramatrix®
  • Kerecis™
  • MariGen™/Kerecis™ Omega3™
  • MatriDerm®
  • Matrix Collagen Wound Dressing
  • Matrix HD™
  • MediHoney®
  • Mediskin®
  • MemoDerm™
  • Miroderm® Biologic Wound Matrix
  • NeoForm™
  • NuCel
  • Oasis® Burn Matrix
  • Oasis® Ultra Tri-Layer Matrix
  • Pelvicol®/PelviSoft®
  • Permacol™
  • PriMatrix™
  • Primatrix™ Dermal Repair Scaffold
  • PuraPly™ wound Matrix (previously FortaDerm™)
  • PuraPly™ AM (Antimicrobial Wound Matrix)
  • Puros® Dermis
  • RegenePro™
  • Repliform®
  • Repriza™
  • StrataGraft
  • Strattice™
  • Suprathel®
  • SurgiMend®
  • Talymed®
  • TenoGlide™
  • TenSIX
  • TheraForm™ Standard/Sheet
  • TheraSkin®
  • TissueMend
  • TruSkin™
  • Veritas® Collagen Matrix
  • WoundEx
  • XCM Biologic Tissue Matrix7
  • XenMatrix™ AB

Note:

For additional information on specific ocular conditions using amniotic products, refer to medical policy #624 Amniotic Membrane Transplantation for the Ocular Surface.

For additional information on all other amniotic products and indications for use, refer to medical policy #597 Amniotic Membrane and Amniotic Fluid.

_____________________________________________________________________________

DESCRIPTION OF PROCEDURE OR SERVICE:

Skin and Soft Tissue Substitutes

Bio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), non-human tissue (xenographic), synthetic materials, or a composite of these materials. Bio-engineered skin and soft tissue substitutes are being evaluated for a variety of conditions, including breast reconstruction and healing lower extremity ulcers and severe burns. Acellular dermal matrix (ADM) 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 (i.e., dermis with cellular material removed) contain a matrix or scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin. The various ADM products can differ in a number of ways, including by species source (human, bovine, porcine), tissue source (e.g. dermis, pericardium, intestinal mucosa), additives (e.g. antibiotics, surfactants), hydration (wet, freeze dried) and required preparation (multiple rinses, rehydration).

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 (e.g., 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. Bioengineered skin substitutes can be used as either temporary or permanent wound coverings.

Applications

There are a large number of potential applications for artificial skin and soft tissue products. One large category is non-healing 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, non-healing 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 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.

For additional information on specific ocular conditions using amniotic products, refer to medical policy #624 Amniotic Membrane Transplantation for the Ocular Surface.

For additional information on all other amniotic products and indications for use, refer to medical policy #597 Amniotic Membrane and Amniotic Fluid Injections.

KEY POINTS:

The literature search for this policy was performed through December 17, 2021.

Although frequently used by surgeons for breast reconstruction, FDA does not consider this homologous use and has not cleared or approved any surgical mesh device (synthetic, animal collagen-derived, or human collagen-derived) for use in breast surgery. The indication of surgical mesh for general use in “Plastic and reconstructive surgery” was cleared by the FDA before surgical mesh was described for breast reconstruction in 2005. FDA states that the specific use of surgical mesh in breast procedures represents a new intended use and that a substantial equivalence evaluation via 510(k) review is not appropriate and a pre-market approval evaluation is required.

Summary of Evidence

Breast Reconstruction

For individuals who are undergoing breast reconstruction who receive allogeneic acellular dermal matric products, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment related morbidity. Results from a systematic review found no difference in overall complication rates with ADM allograft compared to standard procedures for breast reconstruction. Reconstructions with ADM have been reported to have higher seroma, infection, and necrosis rates than reconstructions without ADM. However, capsular contracture and malposition of implants may be reduced. Thus, in cases where there is limited breast tissue for coverage, including but not limited to when the use of ADM allows a single-stage reconstruction, the available noncomparative studies may be considered sufficient to permit conclusions about health outcomes that may inform patient decision making about reconstruction options. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

Tendon Repair

For individuals who are undergoing tendon repair who receive GraftJacket ADM, the evidence includes one RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life and treatment related morbidity. One RCT identified found improved outcomes with GraftJacket ADM allograft for rotator cuff repair. Although these results were positive, additional study with a larger number of subjects is needed to evaluate the consistency of the effect. The evidence is insufficient to determine the effects of the technology on health outcomes.

Surgical Repair of Hernias or Parastomal Reinforcement

For individuals who are undergoing surgical repair of hernias or parastomal reinforcement who receive acellular collagen-based scaffolds, the evidence incudes RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Several comparative studies including RCTs show no difference in outcome between tissue-engineered skin substitutes and either standard synthetic mesh or no reinforcement. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Diabetic Lower-Extremity Ulcers

For individuals who have diabetic lower-extremity ulcers who receive AlloPatch, Apligraf, Dermagraft, or Integra Dermal Regeneration Template, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. RCTs have demonstrated the efficacy of AlloPatch (reticular ADM), Apligraf, Dermagraft (living cell therapy), and Integra Dermal Regeneration Template (biosynthetic) over the standard of care. Several amniotic membrane products have also been shown to improve healing. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

For individuals who have diabetic lower-extremity ulcers who receive ADM products other than AlloPatch, Apligraf, Dermagraft, or Integra, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. Results from a multicenter RCT showed some benefit of DermACELL that was primarily for the subgroup of patients who only required a single application of the ADM. Studies are needed to further define the population who might benefit from this treatment. Additional study with a larger number of subjects is needed to evaluate the effect of Graftjacket, TheraSkin, DermACELL, Cytal, PriMatrix, and Oasis Wound Matrix, compared with current SOC or other advanced wound therapies. The evidence is insufficient to determine the effects of the technology on health outcomes.

Lower-Extremity Ulcers due to Venous Insufficiency

For individuals who have lower-extremity ulcers due to venous insufficiency who receive Apligraf or Oasis Wound Matrix, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. RCTs have demonstrated the efficacy of Apligraf living cell therapy and xenogeneic Oasis Wound Matrix over the standard of care. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive bioengineered skin substitutes other than Apligraf or Oasis Wound Matrix, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. In a moderately large RCT, Dermagraft was not shown to be more effective than controls for the primary or secondary end points in the entire population and was only slightly more effective than controls (an 8%-15% increase in healing) in subgroups of patients with ulcer durations of 12 months or less or size of 10 cm or less. Additional study with a larger number of subjects is needed to evaluate the effect of the xenogeneic PriMatrix skin substitute versus the current standard of care. The evidence is insufficient to determine the effects of the technology on health outcomes.

Dystrophic Epidermolysis Bullosa

For individuals who have dystrophic epidermolysis bullosa who receive OrCel, the evidence includes case series. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. OrCel (living cell therapy) was approved FDA approval under a humanitarian device exemption for use in patients with dystrophic epidermolysis bullosa undergoing hand reconstruction surgery, to close and heals wounds created by the surgery, including those at donor sites. Outcomes have been reported in small series (e.g., five patients). This is a rare disorder and it is unlikely that there will be randomized controlled trials. Therefore, the HDE for OrCel is considered sufficient. OrCel is considered medically necessary for this condition.

Deep Dermal Burns

For individuals who have deep dermal burns who receive bioengineered skin substitutes (i.e., Epicel, Integra Dermal Regeneration Template), the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Overall, there are few skin substitutes approved, and the evidence is limited for each product. Epicel (living cell therapy) has received FDA approval under a humanitarian device exemption for the treatment of deep dermal or full-thickness burns comprising a total body surface area of 30% or more. Comparative studies have demonstrated improved outcomes for biosynthetic skin substitute Integra Dermal Regeneration Template for the treatment of burns. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Clinical Input Received From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2016 Input

In response to requests, input was received from two physician specialty societies and three academic medical centers while this policy was under review in 2016. Input was requested on the equivalency of products within the categories of amniotic membrane, living cell therapies, and biosynthetic skin substitutes for the treatment of diabetic foot ulcers and non-ocular burns (biosynthetic only). Input on the equivalency of products within these categories was mixed.

2014 Input

In response to requests, input was received from three physician specialty societies and four academic medical centers while this policy was under review in 2014. In addition to questions on medical necessity for different indications, input was specifically requested on the equivalency of products within the different categories (eg, ADM, living cell therapy, xenogeneic collagen scaffold, amniotic membrane). Five reviewers addressed the use of ADM products for breast reconstruction, and most considered the various ADM products (AlloDerm, AlloMax, DermaMatrix, FlexHD, GraftJacket) to have similar outcomes when used for breast reconstructive surgery, although differences in firmness and stretch of the products were noted. Six reviewers addressed questions on bio-engineered skin and soft tissue substitutes for diabetic and venous lower-extremity ulcers. Responses were mixed, although most reviewers considered living cell therapies to be equivalent for these indications. Most reviewers did not consider xenogeneic ADM products (eg, PriMatrix) or amniotic membrane (e.g., EpiFix) to be medically necessary for any indication.

Practice Guidelines and Position Statements

American Society of Plastic Surgeons and Wound Healing Society

Review of the literature for 2013 guidelines from the American Society of Plastic Surgeons (ASPS) found that evidence suggests that the use of ADM, although increasingly common in postmastectomy expander/implant breast reconstruction, can result in increased risk of complications in the presence of certain risk factors.  The ASPS notes that cellular dermal matrix is currently used to increase soft tissue coverage, support the implant pocket, improve contour and reduce pain with expansion. However, evidence to support these improved surgical outcomes are limited. Some evidence suggests that use of ADM is associated with increased postoperative complications, specifically related to infection and seroma. Overall, the ASPS found that evidence on ADM products in postmastectomy expander/implant breast reconstruction is varied and conflicting, and gave a Grade C recommendation based on level III evidence that surgeons should evaluate each clinical case individually and objectively determine the use of ADM.

National Institute for Health and Care Excellence

In 2016, the U.K.’s National Institute for Health and Care Excellence (NICE) published clinical guidelines on the prevention and management of diabetic foot problems. NICE recommends that clinicians consider dermal or skin substitutes as an adjunct to standard care when treating diabetic foot ulcers, only when healing has not progressed and on the advice of the multidisciplinary foot care service.

Infectious Diseases Society of America

The 2012 guidelines from the Infectious Diseases Society of America (IDSA) state that for selected diabetic foot wounds that are slow to heal, clinicians might consider using bioengineered skin equivalents (weak recommendation, moderate evidence) growth factors (weak, moderate), granulocyte colony-stimulating factors (weak, moderate), hyperbaric oxygen therapy (strong, moderate), or negative pressure wound therapy (weak, low).  It is emphasized that none of these measures have been shown to improve resolution of infection and that they are expensive, not universally available, may require consultation with experts, and reports supporting their utility are mostly flawed.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

ACell®, acellular dermal matrix, AlloDerm®, AlloMax™, AlloMend, AlloSkin™ RT, ArthroFlex™ (FlexGraft), AlloSkin™, AlloSkin AC, Aongen, Apligraf®, Architect extracellular matrix, Atlas, Avagen, AvaultaPlus™, AxoGuard, Banked Human Tissue, Biobrane®, CellerateRX®, bio-engineered soft tissue substitutes, Bio-engineered skin substitutes, biosynthetic wound dressing, collagen scaffold, Collaguard, CollaSorb, CollaWound, Collexa, Collieva, Conexa™, Grafix®, Coreleader, CorMatrix®CRXa™, Cymetra®, Cytal ™, Dermacell, Dermadapt, Dermagraft®, DermaMatrix Acellular DermisDurepair Regeneration Matrix®, Dermapure™, DressSkin, dystrophic epidermolysis bullosa, Endoform Dermal Template™, ENDURAgen™, Excellagen, E-Z Derm™, FlexHD® Acellular Hydrated Dermis, GammaGraftGrafix®, GraftJacket®, hMatrix®, Helicoll, Hyalomatrix® PA, injectable, Innocoll, Integra Dermal Regeneration Template™, Integra™ Bilayer Wound Matrix, Integra™ Flowable Wound Matrix, HA, Hyalomatrix, Jaloskin, Keramatrix, Kerecis, Laserskin, living cell therapy, MariGen, MatriDerm®, MatriStem® Burn Matrix, MatriStem® Micromatrix, MatriStem® Wound Matrix, Matrix, Matrix HD™, MediHoney®, Mediskin®, MemoDerm™, Miroderm ® biologic wound matrix, Oasis® Burn Matrix, Oasis® Ultra Tri-Layer Matrix, Permacol™, OrCel™, PriMatrix, PuraPly™ wound Matrix, PuraPly™ AM, Puros, Regenerative Tissue Matrix GraftJacket®, Repliform, Repriza™, SIS, SS, Stimulen, StrataGraft, Strattice™ (xenograft), Suprathel®, SurgiMend®, Talymed®, TenoGlide™, Tensix, TheraForm, TheraSkin®Unite™, TransCyte™, TransCyte™, TruSkin™, Veritas® Collagen Matrix, Xcm biologic tissue matrix, XenMatrix™ AB, Xpress, Cortiva, Avance® nerve graft, Axoguard® nerve connector, AxoGuard® Nerve Protector (AxoGen), NeuraGen® nerve guide, NeuraWrap™ nerve protector, Neuroflex™ collagen conduit, NeuroMatrix™ collegen conduit, NeuroMend™ collagen wrap

APPROVED BY GOVERNING BODIES:

There are a large number of artificial skin products that are commercially available or in development. The following summary of commercially available skin substitutes describes those products that have substantial relevant evidence on efficacy. Information on additional products is available in a 2020 Technical Brief on skin substitutes for treating chronic wounds that was commissioned by the Agency for Healthcare Research and Quality.

Acellular Dermal Matrix

Allograft acellular dermal matrix products derived from donated human skin tissue are supplied by U.S. AATB-compliant tissue banks using the standards of the American Association of Tissue Banks (AATB) and U.S. Food and Drug Administration's (FDA) guidelines. The processing removes the cellular components (i.e., epidermis and all viable dermal cells) that can lead to rejection and infection.  Acellular dermal matrix products from human skin tissue are regarded as minimally processed and not significantly changed in structure from the natural material; the FDA classifies it as banked human tissue and therefore does not require FDA approval.

  • AlloDerm® (LifeCell Corporation) is an acellular dermal matrix (allograft) tissue-replacement product that is created from native human skin and processed so that the basement membrane and cellular matrix remain intact. Originally, AlloDerm required refrigeration and rehydration prior to use. It is currently available in a ready-to-use product that is stored at room temperature.  An injectable micronized form of AlloDerm (Cymetra) is also available.
  • Cortiva® (previously marketed as AlloMax™ Surgical Graft and before that NeoForm™) is an acellular non-cross-linked human dermis allogra.
  • AlloPatch® (Musculoskeletal Transplant Foundation) is an acellular human dermis allograft derived from the reticular layer of the dermis and marketed for wound care. This product is also marketed as FlexHD® for postmastectomy breast reconstruction.
  • FlexHD® (Musculoskeletal Transplant Foundation) is an acellular hydrated dermis derived from donated human allograft skin.
  • DermaCell™ (LifeNet Health) is an allogeneic ADM processed with proprietary technologies MATRACELL® and PRESERVON®.
  • DermaMatrix™ (Synthes) is a freeze dried acellular dermal matrix derived from donated human skin tissue. DermaMatrix Acellular Dermis is processed by the Musculoskeletal Transplant Foundation® (MTF®).
  • DermaPure™ (Tissue Regenix Wound Care Inc.) is a single layer decellularized human dermal allograft for the treatment of acute and chronic wounds.
  • GraftJacket® Regenerative Tissue Matrix (also called Graftjacket Skin Substitute; KCI) is an acellular regenerative tissue matrix that has been processed from human skin supplied from U.S. tissue banks. The allograft is minimally processed to remove the epidermal and dermal cells, while preserving dermal structure. Graftjacket Xpress® is an injectable product.

Although frequently used by surgeons for breast reconstruction, FDA does not consider this homologous use and has not cleared or approved any surgical mesh device (synthetic, animal collagen-derived, or human collagen-derived) for use in breast surgery. The indication of surgical mesh for general use in “Plastic and reconstructive surgery” was cleared by the FDA before surgical mesh was described for breast reconstruction in 2005. FDA states that the specific use of surgical mesh in breast procedures represents a new intended use and that a substantial equivalence evaluation via 510(k) review is not appropriate and a pre-market approval evaluation is required.

In March 2021, FDA issued a Safety Communication to inform patients, caregivers, and health care providers that certain ADM products used in implant-based breast reconstruction may have a higher chance for complications or problems. An FDA analysis of patient-level data from real-world use of ADMs for implant-based breast reconstruction suggested that 2 ADMs—FlexHD and Allomax—may have a higher risk profile than others.

In October 2021, an FDA advisory panel on general and plastic surgery voted against recommending FDA approval of the SurgiMend mesh for the specific indication of breast reconstruction. The advisory panel concluded that the benefits of using the device did not outweigh the risks.

Xenogeneic Products

Cytal™ (previously called MatriStem®) Wound Matrix, Multilayer Wound Matrix, Pelvic Floor Matrix, MicroMatrix, and Burn Matrix (all manufactured by ACell) are composed of porcine-derived urinary bladder matrix.

Helicoll (Encol) is an acellular collagen matrix derived from bovine dermis. In 2004, it was cleared for marketing by the FDA through the 510(k) process for topical wound management that includes partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (eg, abrasions, lacerations, second-degree bums, skin tears), and surgical wounds including donor sites/grafts.

Keramatrix® (Keraplast Research) is an open-cell foam comprised of freeze-dried keratin that is derived from acellular animal protein. In 2009, it was cleared for marketing by the FDA through the 510(k) marketing process under the name of Keratec. The wound dressings are indicated in the management of the following types of dry, light, and moderately exudating partial and full-thickness wounds: pressure (stage I-IV) and venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites, and grafts.

Kerecis™ Omega3 Wound (Kerecis) is an ADM derived from fish skin. It has a high content of omega 3 fatty acids and is intended for use in burn wounds, chronic wounds, and other applications.

Permacol™ (Covidien) is xenogeneic and composed of cross-linked porcine dermal collagen. Crosslinking improves the tensile strength and long-term durability, but decreases pliability.

PriMatrix™ (TEI Biosciences; a subsidiary of Integra Life Sciences) is a xenogeneic ADM processed from fetal bovine dermis. It was cleared for marketing by the FDA through the 510(k) process for partial- and full-thickness wounds; diabetic, pressure, and venous stasis ulcers; surgical wounds; and tunneling, draining, and traumatic wounds.

SurgiMend® PRS (TEI Biosciences) is a xenogeneic ADM processed from fetal bovine dermis.

Strattice™ Reconstructive Tissue Matrix (LifeCell Corp) is a xenogeneic non-cross-linked porcine-derived ADM. There are pliable and firm versions, which are stored at room temperature and come fully hydrated.

OASIS™ Wound Matrix (Cook Biotech) is a xenogeneic collagen scaffold derived from porcine small intestinal mucosa. It was cleared for marketing by the FDA’s 510(k) process in 2000 for the management of partial- and full-thickness wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled undermined wounds, surgical wounds, trauma wounds, and draining wounds.

Living Cell Therapy

Apligraf® (Organogenesis) is a bi-layered living cell therapy composed of an epidermal layer of living human keratinocytes and a dermal layer of living human fibroblasts. Apligraf® is supplied as needed, in one size, with a shelf-life of 10 days. It was FDA-approved in 1998 for use in conjunction with compression therapy for the treatment of non-infected, partial- and full-thickness skin ulcers due to venous insufficiency and in 2001 for full-thickness neuropathic diabetic lower extremity ulcers nonresponsive to standard wound therapy.

Dermagraft® (Organogenesis) is composed of cryopreserved human-derived fibroblasts and collagen derived from newborn human foreskin and cultured on a bioabsorbable polyglactin mesh scaffold. Dermagraft has been approved by the FDA for repair of diabetic foot ulcers.

TheraSkin® (Soluble Systems) is a cryopreserved split-thickness human skin allograft composed of living fibroblasts and keratinocytes and an extracellular matrix in epidermal and dermal layers. TheraSkin® is derived from human skin allograft supplied by tissue banks compliant with the American Association of Tissue Banks and FDA guidelines. It is considered a minimally processed human cell, tissue, and cellular- and tissue-based product by the FDA.

Epicel® (Genzyme Biosurgery) is an epithelial autograft composed of a patient’s own keratinocytes cultured ex vivo and is FDA-approved under a humanitarian device exemption for the treatment of deep dermal or full-thickness burns comprising a total body surface area of 30% or more. It may be used in conjunction with split-thickness autografts or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

OrCel™ (Forticell Bioscience) (formerly called Composite Cultured Skin) is an absorbable allogeneic bi-layered cellular matrix, made of bovine collagen, in which human dermal cells have been cultured. It was approved by the FDA premarket approval (PMA) for healing donor site wounds in burn victims and under a humanitarian device exemption (HDE) for use in patients with recessive dystrophic epidermolysis bullosa undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites.

Biosynthetic Products

Biobrane®/Biobrane-L (Smith and Nephew) is a biosynthetic wound dressing constructed of a silicon film with a nylon fabric partially imbedded into the film. The fabric creates a complex three dimensional structure of tri-filament thread, which chemically binds collagen. Blood/sera clot in the nylon matrix, adhering the dressing to the wound until epithelialization occurs.

Integra® Dermal Regeneration Template (also marketed as Omnigraft Dermal Regeneration Matrix; Integra LifeSciences) is a bovine, collagen/glycosaminoglycan dermal replacement covered by a silicone temporary epidermal substitute. It was approved by the FDA for use in the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injury where sufficient autograft is not available at the time of excision or not desirable because of the physiologic condition of the patient, and for certain diabetic foot ulcers. Integra® Matrix Wound Dressing and Integra® Meshed Bilayer Wound Matrix are substantially equivalent skin substitutes and were cleared for marketing by the FDA through the 510(k) process for other indications. Integra® Bilayer Matrix Wound Dressing (Integra LifeSciences) is designed to be used in conjunction with negative pressure wound therapy. The meshed bilayer provides a flexible wound covering and allows drainage of wound exudate.

TransCyte™ (Advanced Tissue Sciences) consists of human dermal fibroblasts grown on nylon mesh, combined with a synthetic epidermal layer and was approved by the FDA in 1997. TransCyte is intended to be used as a temporary covering over burns until autografting is possible. It can also be used as a temporary covering for some burn wounds that heal without autografting.

Synthetic Products

Suprathel® (PolyMedics Innovations) is a synthetic copolymer membrane fabricated from a tripolymer of polylactide, trimethylene carbonate, and s-caprolactone. It is used to provide temporary coverage of superficial dermal burns and wounds. Suprathel® is covered with gauze and a dressing that is left in place until the wound has healed.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

HCPCS Codes:

A2011 Supra sdrm, per square centimeter (Effective 04/01/22)
A2012 Suprathel, per square centimeter (Effective 04/01/22)
A4100 Skin substitute, fda cleared as a device, not otherwise specified (Effective 04/01/22)

A6460

Synthetic resorbable wound dressing, sterile, pad size 16 sq. in. or less, without adhesive border, each dressing (Effective 01/01/2019)

A6461

Synthetic resorbable wound dressing, sterile, pad size more than 16 sq. in. but less than or equal to 48 sq. in., without adhesive border, each dressing (Effective 01/01/2019)

C1849

Skin substitute, synthetic, resorbable, per sq cm

C9354                  

Acellular pericardial tissue matrix of nonhuman origin (Veritas), per sq cm

C9356

Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (TenoGlide Tendon Protector Sheet), per sq cm

C9358

Dermal substitute, native, nondenatured collage, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 square centimeters

C9360

Dermal substitute, native, nondenatured collage, neonatal bovine origin (SurgiMend collagen Matrix), per 0.5 square centimeters

C9363

Skin substitute, Integra Meshed Bilayer Wound Matrix, per sq cm

C9364

Porcine implant, Permacol, per sq cm

C9367

Skin substitute, Endoform Dermal Template, per sq cm

Q4100

Skin substitute, not otherwise specified

Q4101

Apligraf, per sq cm

Q4102

Oasis wound matrix, per sq cm

Q4103

Oasis burn matrix, per sq cm

Q4104

Integra bilayer matrix wound dressing (BMWD), per sq cm

Q4105

Integra dermal regeneration template (DRT), or Integra Omnigraft dermal regeneration matrix, per sq cm

Q4106

Dermagraft, per sq cm

Q4107

GRAFTJACKET, per sq cm

Q4108

Integra matrix, per sq cm

Q4110

PriMatrix, per sq cm

Q4111

GammaGraft, per sq cm

Q4112

Cymetra, injectable, 1 cc

Q4113

GRAFTJACKET Express, injectable 1 cc

Q4114

Integra flowable wound matrix, injectable, 1 cc

Q4115

AlloSkin, per sq cm

Q4116

AlloDerm, per sq cm

Q4117

HYALOMATRIX, per sq cm

Q4118

MatriStem micromatrix, per sq cm

Q4121

TheraSkin, per sq cm

Q4122

Dermacell, per sq cm

Q4123

Alloskin RT, per sq cm

Q4124

Oasis Ultra Tri-Layer Wound Matrix, per sq cm

Q4125

Arthroflex, per sq cm

Q4126

Memoderm, per sq cm

Q4127

Talymed, per sq cm

Q4128

FlexHD OR Allopatch HD, per sq cm

Q4130

Strattice TM, per sq cm

Q4134

hMatrix, per sq cm

Q4135

Mediskin, per sq cm

Q4136

EZ-derm, per sq cm

Q4141

Alloskin ac, per sq cm

Q4142

Xcm biologic tissue matrix, per sq cm

Q4143

Repriza, per sq cm

Q4146

Tensix, per sq cm

Q4147

Architect, architect px, or architect fx, extracellular matrix, per sq cm

Q4149

Excellagen, 0.1cc

Q4152

DermaPure, per square centimeter

Q4161

Bio-conneKt wound matrix, per square centimeter

Q4164

Helicoll, per square centimeter

Q4165

Keramatrix, per square centimeter

Q4166

Cytal, per sq cm (Effective 01/01/17)

Q4167

Truskin, per sq cm (Effective 01/01/17)

Q4175

Miroderm, per sq cm (Effective 01/01/17)

Q4179

FlowerDerm, per sq cm

Q4182

Transcyte, per square centimeter (Effective 01/01/18)

Q4193   

Coll-e-derm, per square centimeter (Effective 01/01/2019)

Q4195      

Puraply, per square centimeter (Effective 01/01/2019)

Q4196      

Puraply am, per square centimeter (Effective 01/01/2019)

Q4197      

Puraply xt, per square centimeter (Effective 01/01/2019)

Q4200      

Skin te, per square centimeter (Effective 01/01/2019)

Q4202    

Keroxx (2.5g/cc), 1cc (Effective 01/01/2019)

Q4203   

Derma-gide, per square centimeter (Effective 01/01/2019)

Q4222

ProgenaMatrix, per square centimeter (Effective 10/01/19)

Q4226

MyOwn Skin, includes harvesting and preparation procedures, per square centimeter (Effective 10/01/19)

PREVIOUS CODING:

Q4172

PuraPly or Pura Ply AM, per sq cm (Deleted 12/31/18)

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  79. Santema TB, Poyck PP, Ubbink DT. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev. 2016; 2:CD011255.
  80. Scheflan M, Grinberg-Rashi H, Hod K. Bovine acellular dermal matrix in immediate breast reconstruction: a retrospective, observational study with SurgiMend. Plast Reconstr Surg. 2018; 141(1):1e-10e.
  81. Seth AK, Persing S, Connor CM et al. A comparative analysis of cryopreserved versus prehydrated human acellular dermal matrices in tissue expander breast reconstruction. Annals of Plastic Surgery 2013; 70(6):632-635.
  82. Sinha UK, Saadat D, Doherty CM et al. Use of AlloDerm implant to prevent Frey syndrome after parotidectomy. Arch Facial Plast Surg 2003; 5(1):109-112.
  83. Snyder DL, Sullivan N, Margolis DJ, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Rockville, MD: Agency for Healthcare Research and Quality. February 2020. Available at: http://www.ahrq.gov/research/findings/ta/index.html. Accessed December 15, 2020.
  84. Snyder DL, Sullivan N, Schoelles KM. Skin Substitutes for Treating Chronic Wounds. Research conducted by the ECRI Institute Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract Number: HHSA 290-2007-10063). 2012. Available online at: www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf.
  85. Steinberg JS, Edmonds M, Hurley DP, Jr. et al. Confirmatory data from EU study supports Apligraf for the treatment of neuropathic diabetic foot ulcers. J Am Podiatr Med Assoc 2010; 100(1):73-77.
  86. Taras JS, Sapienza A, Roach JB et al. Acellular dermal regeneration template for soft tissue reconstruction of the digits. J Hand Surg Am 2010; 35(3):415-421.
  87. TEI Biosciences [website]. SurgiMend. Collagen matrix for soft tissue reconstruction. Integra TEI Biosciences; Boston, MA. Available at: http://www.teibio.com/SurgiMend.aspx. Accessed March 2019.
  88. U.S. Food and Drug Administration (FDA). SurgiMend. 510(k) Summary. K071807. TEI Biosciences Inc.  Boston, MA. Rockville, MD: FDA; August 6, 2007. Available at: http://www.fda.gov/cdrh/pdf7/K072113.pdf. Accessed March 2019.
  89. U.S. Food and Drug Administration. Executive Summary Breast Implant Special Topics. March 2019. https://www.fda.gov/media/122956/download. Accessed December 15, 2020.
  90. U.S. Food and Drug Administration. Executive Summary Breast Implant Special Topics. March 2019. https://www.fda.gov/media/122956/download. Accessed December 15, 2020.
  91. U.S. Food and Drug Administration. Guidance for industry: Chronic cutaneous ulcer and burn wounds. 2006; www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071324.pdf. Accessed December 22, 2016.
  92. U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. December 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal. Accessed December 15, 2020.
  93. Uccioli L, Giurato L, Ruotolo V, et al. Two-step autologous grafting using HYAFF scaffolds in treating difficult diabetic foot ulcers: results of a multicenter, randomized controlled clinical trial with long-term follow-up. The international journal of lower extremity wounds. Jun 2011;10(2):80-85.
  94. Walters J, Cazzell S, Pham H, et al. Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full-thickness diabetic foot ulcers. Eplasty. 2016; 16:e10.
  95. Weigert R, Choughri H, Casoli V. Management of severe hand wounds with Integra(R) dermal regeneration template. J Hand Surg Eur Vol 2011; 36(3):185-193.
  96. Zelen CM, Orgill DP, Serena T, et al. A prospective, randomized, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers. Int Wound J. Apr 2017; 14(2):307-315.
  97. Zelen CM, Orgill DP, Serena TE, et al. An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial. International wound journal. Oct 2018;15(5):731-739.
  98. Zelen CM, Serena TE, Snyder RJ. A prospective, randomized comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014 Apr; 11(2): 122-128.
  99. Zelen CM, Snyder RJ, Serena TE, et al. The Use of Human Amnion/Chorion Membrane in the Clinical Setting for Lower Extremity Repair: A Review. Clin Podiatr Med Surg. Jan 2015; 32(1):135-146.
  100. Zelen CM. An evaluation of dehydrated human amniotic membrane allograft in patients with DFUs. J Wound Care. 2013; 22(7): 347-348.
  101. Zhong T, Janis JE, Ahmad J et al. Outcomes after abdominal wall reconstruction using acellular dermal matrix: a systematic review. J Plast Reconstr Aesthet Surg 2011; 64(12):1562-1571.

POLICY HISTORY:

Medical Policy Panel, January 2013

Medical Policy Group, April 2013 (2): New Policy

Medical Policy Administration Committee, August 2013

Available for comment August 22 through October 5, 2013

Medical Policy Group, December 2013 (3):  2014 Coding Update – added new codes Q4137, Q4138, Q4139, Q4140, Q4141, Q4142, Q4143, Q4145, Q4146, Q4147, Q4148, Q4149 (effective 01/01/2014)

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (3):  Updates to Policy statements, Key Points, Governing Bodies, Key Words, & References; added coverage statement for treatment of upper and lower eyelid retraction or conjunctival contraction requiring soft tissue spacer or replacement with AlloDerm®; added graft names under breast reconstructive surgery and updated list of grafts considered investigational.

Medical Policy Administration Committee, March 2014

Available for comment February 26 through April 11, 2014

Medical Policy Group, November 2014: 2015 Annual Coding Update – Updated code Q4147 with ‘architect px, or architect fx’ and added HCPCS codes Q4150, Q4150, Q4153-Q4157, Q4159 and Q4160.

Medical Policy Panel, January 2015

Medical Policy Group, April 2015 (3): Updates to Description, Key Points, Approved Governing Bodies, Key Words, & References.  Thirteen new skin and soft tissue substitutes were added to the list considered investigational.  No change to policy intent.

Medical Policy Group, November 2015: 2016 Annual Coding Update. Added new HCPCS codes Q4161, Q4164, and Q4165 to current coding. Revised HCPCS code Q4153 to add Plurivest

Medical Policy Group, May 2016 (3):  Removed information related to “ocular burns” from Key Points (literature review & summary) & References (removed Clare et al 2012) and transferred to new medical policy #624; no other changes made to current policy

Medical Policy Panel, June 2016

Medical Policy Group, June 2016 (3): 2016 Updates to Description, Key Points, Governing Bodies, Key Words, Coding & References; policy statements updated to reflect addition of Integra® Dermal Regeneration Template and Amniotic membrane Graft* (including Biovance®, Epifix®, Grafix™) to coverage criteria for the treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers; removed these from noncovered list; updated noncovered list with additional products not considered to meet medical criteria for coverage

Medical Policy Administration Committee, August 2016

Available for comment August 1 through September 14, 2016

Medical Policy Group, December 2016: 2017 Annual Coding Update. Added new CPT codes Q4166 – Q4175 to current coding.  Created Previous Coding section and moved deleted codes Q4119, Q4120, and Q4129 to this section. Updated verbiage for revised codes Q4105 and Q4131.

Medical Policy Panel, January 2017

Medical Policy Group, May 2017 (3): 2017 Updates to Key Points, Key Words, Approved by Governing Bodies, Current Coding & Reference sections; removed all information related to amniotic products and relocated those to medical policy #597; removed policy section statements for dates of service prior to January 1, 2014; Policy section also updated by adding coverage criteria for AlloPatch and Allomax; added multiple products to ones considered investigational.

Medical Policy Administration Committee, June 2017

Available for comment May 31 through July 14, 2017

Medical Policy Panel, June 2017

Medical Policy Group, July 2017 (3):  added Cortiva™ to IV list; removed Cellerate® from IV list; no change in other policy statements; no change in comment period

Medical Policy Panel ad hoc product update, August 2017

Medical Policy Group, August 2017 (3):  Clarified policy statement regarding Integra® Dermal Regeneration Template and Integra® Omnigraft Dermal Regeneration Matrix (Omnigraft®)

Medical Policy Group, December 2017: Annual Coding Update 2018. Added new HCPCS codes Q4176 and Q4182 to the Current Coding section.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (3):  2018 Updates to Description, Key Points, Governing Bodies, Key Words, & References; Policy statements updated to include coverage criteria for DermACELL, FlexHD Pliable and Integra Flowable Wound Matrix as indicated

Available for comment March 14 through April 27, 2018

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added HCPC codes A6460, A6461, Q4193, Q4195, Q4196, Q4197,Q4200, Q4202, and Q4203 to the Current coding section. Moved HCPC code from Current coding section to Previous coding.  Updated  Previous coding section to include code Q4172.

Medical Policy Panel, January 2019

Medical Policy Group, March 2019 (7):  2019 Updates to Key Points & References. Removed old policy statement for dates of service on or after January 9, 2014 and prior to July 1, 2016. No change in Policy Statement.

Medical Policy Group, January 2020 (7): Policy Statement updated updated to include coverage criteria for Cortiva which was previously marketed as AlloMax. Cortiva removed from noncovered list. Added Key Word: Cortiva. Deleted codes Q4119, Q4120, and Q4129 from Previous Coding Section, deleted effective 12/31/16. Available for comment January 23, 2020 through March 8, 2020.

Medical Policy Group, June 2020: Quarterly coding update.  Revised HCPCS code Q4176 to include “or therion”.

Medical Policy Group, June 2020 (5): Added new HCPCS codes from 10/1/19 to Current Coding. Codes include: Q4220, Q4222 , Q4226.

Medical Policy Panel, January 2021

Medical Policy Group, February 2021 (5): Updates to Key Points, Approved by Governing Bodies, and References. Current Coding section updated to inclue the following codes: C1849, C9356, and Q4179. Policy Statement updated to include additional investigational Bio-Engineered Skin and Soft Tissue Substitute products. Policy Statement updated to include: Bio-Engineered Skin and Soft Tissue Substitutes for use in surgical repair of complex abdominal wall wounds (e.g., fascial defect, hernia repair, infection, etc.) are considered investigational. Available for comment: February 5, 2021 through March 22, 2021.

Medical Policy Group, April 2021 (5): Update to Key Points. No change to Policy Statement.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Group, February 2022 (5): Removed HCPCS codes Q4176 and Q4220 from this policy, and added to MP#597-Amniotic Membrane and Amniotic Fluid. No change to Policy Statement.

Medical Policy Group, March 2022 (5): Updates to Key Words to include: Avance® nerve graft, Axoguard® nerve connector, AxoGuard® Nerve Protector (AxoGen), NeuraGen® nerve guide, NeuraWrap™ nerve protector, Neuroflex™ collagen conduit, NeuroMatrix™ collegen conduit, NeuroMend™ collagen wrap. Policy Statement non-coverage list updated to include additional synthetic conduits and nerve allograft products. These products were previously investigational per this policy. No change to Policy intent.

Medical Policy Group, March 2022 (5): Quarterly Coding Update. Added HCPCS codes A2011, A2012, and A4100 to Current Coding Section.

                                                                                                                                               

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.