Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    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 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.

2)    Preauthorization is required for Apligraf® and Oasis™ for chronic lower extremity venous ulcers.

3)    QualChoice covers the use of the following:

a)    AlloDerm® or DermACELL® for breast reconstruction;

b)    EpiFix®, Apligraf®, DermACELL®, Dermagraft® or Grafix® for noninfected full-thickness diabetic lower extremity ulcers;

c)    Dermagraft® or OrCel™ for dystrophic epidermolysis bullosa, and Integra Dermal Regeneration Template™, TransCyte™, or Epicel® for certain second and third degree burns. 

d)    Other products, or use of these products for other purposes, are considered investigational and are not covered. Please see BI383.

e)    Use of noncontact real-time fluorescence wound imaging for bacterial presence (to determine when to apply skin substitutes) is also considered investigational and is not covered.

1)    AlloDerm is considered medically necessary for prevention of Frey syndrome when performing parotidectomy with preservation of the facial nerve.

2)    The use of AlloDerm® or DermACELL for breast reconstruction is considered medically necessary:

a)    When there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required; OR

b)    When there is viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or necrosis; OR

c)    When the infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-establishment of these landmarks is needed.

3)    Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers (as part of standard wound care) includes optimization of blood sugars, nutritional status, and circulation. Hgb A1C (< 12%), protein, albumin, smoking cessation, and ABIs (≥0.70) should all be adequately addressed. If all of these have been addressed, treatment with the following tissue-engineered skin substitutes is considered medically necessary (in conjunction with standard wound therapy): Apligraf®, DermACELL®, Dermagraft®, EpiFix® or Grafix®.

4)    Treatment of chronic, non-infected, partial- or full-thickness lower extremity skin ulcers due to venous insufficiency, which have not adequately responded following a six-month period of conventional ulcer therapy (which includes optimizing nutritional, metabolic and circulatory issues as described above), with the following tissue-engineered skin substitutes is considered medically necessary (requires preauthorization):

·         Apligraf®  

·         Oasis™ Wound Matrix

5)    Treatment of dystrophic epidermolysis bullosa with  the following tissue-engineered skin substitutes is considered medically necessary:

·         Dermagraft®

·         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)

6)    Treatment of 2nd and 3rd degree burns with the following tissue-engineered skin substitutes is considered medically necessary:

·         Epicel® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area of > or = to 30% when provided in accordance with the HDE specifications of the FDA);

·         Integra Dermal Regeneration Template™;

·         TransCyte™.

Codes Used In This BI:

All other uses of bio-engineered skin and soft tissue substitutes are considered experimental or investigational because of lack of scientific literature to support other uses.

Similarly, noncontact real-time fluorescence wound imaging for bacterial presence is considered experimental or investigational.

1)    Lukish JR, Eichelberger MR, et al. (2001). The use of a bioactive skin substitute decreases length of stay for pediatric burn patients. J Pediat Surg, 2001; 36:1118-21.

2)    Amani J, Dougherty WR, Blome-Eberwein S. (2006) Use of Transcyte and dermabrasion to treat burns reduces length of stay in burns of all size and etiology. Burns, 2006; 32:828-32.

3)    Athavale SM, Phillips S, et al. (2011) Complications of AlloDerm and derma matrix for parotidectomy reconstruction. Head Neck, 2012; 34:88-93 [Epub 2011 Apr].

4)    Branski LK, Herndon DN, et al. (2007) longitudinal assessment of Integra in primary burn management: a randomized pediatric clinical trial. Critical Care Med, 2007; 35:2615-23.

5)    Brigido, Boc SF, Lopez RC. (2004) Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study, Orthopedics, 2004; 27 (1 Suppl):s145-9.

6)    Carsin H, Ainaud P, et al. (2000) Cultured epithelial autografts in extensive burn coverage of severely traumatized patients: a five-year single-center experience with 30 patients. Burns, 2000; 26:379-87.

7)    Colwell AS, Breuing KH. (2008) Improving shape and symmetry in mastopexy with autologous or cadaveric dermal slings. Ann Plast Surg, 2008; 61:138-42.

8)    Espinosa-de-los-monteros A, de la Torre JI, et al. (2007) Utilization of human cadaveric acellular dermis for abdominal hernia reconstruction. Ann Plast Surg, 2007; 58:264-7.

9)    Falanga V, Margolis D, et al. (1998) rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Human Skin Equivalent Investigators Group. Arch Dermat, 1998; 134:293-300.

10)   Garramone, CE, Lam B. (2007) Use of AlloDerm in primary nipple reconstruction to improve long-term nipple projection. Plast Reconst Surg, 2007; 119:1663-8.

11)   Girod DA, Sykes K, et al. (2009) acellular dermis compared to skin grafts or oral cavity reconstruction. Laryngoscope, 2009; 119:214-9.

12)   Gupta A, Zahriya K, et al. (2006) Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and AlloDerm. Hernia, 2006; 10:419-25.

13)   Hayes Technology Assessment:  Biological Tissue-Engineered Skin Substitutes for Wound Healing. Published January 28, 2010, updated January 16, 2012.

14)   Hayes Technology Assessment:  Biosynthetic Tissue-Engineered Skin Substitutes for Wound Healing.  Published January 14, 2010, updated February 21, 2012.

15)   Heimbach DM, Warden GD, et al.(2003) Multicenter post approval clinical trial of Integra dermal regeneration template for burn treatment; J Burn Care Rehab, 2003, 24:42-8.

16)   Helgeson MS, Potter BK, et al. (2007) Bio artificial dermal substitute: a preliminary report on its use for the management of complex combat-related soft tissue wounds. J Orthop Trauma, 2007; 21:394-9.

17)   Hope HW, Ueno C, et al. (2006) Guidelines for the treatment of arterial insufficiency ulcers. Wound Repair Regen, 2006; 14:693-710

18)   Jamal JE et al. (2010) a randomized prospective trial of primary versus AlloDerm closure of buccal mucosal graft harvest site for substitution urethroplasty.  Urology, 2010; 75(3) L 695-700.

19)   Karr JC. (2011) Retrospective comparison of diabetic foot ulcer and venous stasis ulcer healing outcome between a dermal repair scaffold (PriMatrix) and a bilayered living cell therapy (Apligraf). Adv Skin Wound Care, 2011; 24:119-25.

20)   Kirsner RS, Warriner R, et al. (2010) Advanced biological therapies for diabetic foot ulcers. Arch Dermatol, 2010; 146:857-62.

21)   Mostow EN, Haraway GD, et al. (2005) Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized controlled clinical trial. J Vasc Surg, 2005; 41:837-43.

22)   Movaes AB Jr., de Barros RR. (2008) acellular dermal matrix allograft. The results of controlled randomized clinical studies. J Int Acad Periodontal, 2008; 10:123-9.

23)   Niezgoda JA, Van Gils CC, et al. (2005) Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care, 2005; 18 (5 Pt 1):258-86.

24)   Preminger BA, McCarthy CM, et al. (2008) the influence of AlloDerm on expander dynamics and complications in the setting of immediate tissue expander/implant reconstruction: a matched cohort study. Ann Plast Surg, 2008; 60:510-3.

25)   Reyzelman A, Crews RT, et al.(2009) Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcer: a prospective, randomized, multicenter study. Int Wound J, 2009; 6:196-208.

26)   Romanelli M, Dini V, et al. (2007) OASIS wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous a etiology. Int Wound J, 2007; 4:3-7.

27)   Romanelli M, Dini V, et al. (2010) Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Adv Skin Wound Care, 2010; 23:34-8.

28)   Sinha UK, Saadat D, et al. (2003) Use of AlloDerm implant to prevent Frey syndrome after parotidectomy. Arch Facial Plast Surg, 2003; 5:109-12.

29)   Steed DL, Attinger C, et al. (2006) Guidelines for the treatment of diabetic ulcers. Wound Repair Regen, 2006; 14:680-92.

30)   Steinberg JS, Edmonds M, et al. (2010) Confirmatory data from EU study supports Apligraf for the treatment of neuropathic diabetic foot ulcers.J Am Podiat Med Assoc, 2010; 100:73-7.

31)   Still J, Giat P, et al. (2003) the use of a collagen sponge/living cell composite material to treat donor sites in burn patients. Burns, 2003; 29:837-41.

32)   Taras JS, Sapienza A, et al. (2010) acellular dermal regeneration template for soft tissue reconstruction of the digits. J Hand Surg Am, 2010; 35:415-21.

33)   Veves A, Falanga V, et al. (2001) Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care, 2001; 24:290-5.

34)   Vos JD, Latev MD, et al. (2005) Use of AlloDerm in type 1 tympanoplasty: a comparison with native tissue grafts. Laryngoscope, 2005; 115:1599-601.

35)   Weigert R, Choughri H, Casoli V. (2011) Management of severe hand wounds with Integra® dermal regeneration template. J Hand Surg Eur, 2011; 36:185-93.

36)   Ye WM, Zhu HG, et al. (2008) Use of allogenic acellular dermal matrix in prevention of Frey`s syndrome after parotidectomy. Br J Oral Maxillofacial Surg, 2008; 46:649-52.

37)   Zelen CM, Serena TE, et al. (2016) Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomized, controlled, multi-centre comparative study examining clinical efficacy and cost. International Wound Journal, 2016; 13(2):272-282.

38)   Zenn MR, Salzberg CA. A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Eplasty. 2016; 16:e23.

39)   Pittman T, Fan K, et al. (2017) Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plastic & Reconstructive Surgery, 2017; 139(3):521-528.

40)   Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. 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.

41)   Zeng XT, et al. AlloDerm implants for prevention of Frey syndrome after parotidectomy: A systematic review and meta-analysis. Molecular Medicine Reports. 2012; 5(4):974-980.

42)   Sinha UK, et al. Use of AlloDerm Implant to Prevent Frey Syndrome after Parotidectomy. Arch Facial Plast Surg. 2003; 5(1):109-112.

43)   Frykberg, R. G., Gibbons, G. W., Walters, J. L., Wukich, D. K. and Milstein, F. C. (2017), A prospective, multicentre, open‐label, single‐arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. Int Wound J, 14: 569-577.

Addendum:

1)    Effective 05/01/2017: Added EpiFix and DermACELL for diabetic lower extremity ulcers and DermACELL for breast reconstruction.

2)    Effective 02/01/2018: Added AlloDerm indication for prevention of Frey syndrome with nerve-sparing parotidectomy.

3)    Effective 03/06/2018: Added new 2018 codes

4)    Effective 09/01/2018: Added Grafix for diabetic lower extremity ulcers.

5)    Effective 01/01/2019: 2019 Code Updates. Deleted HCPCS code Q4131 and updated code description for Q4133. Also added the following new HCPCS codes to policy: Q4183 – Q4204. Also, CPT codes updated and aligned with BI383.

6)    Effective 07/01/2020: New codes added (C1849, Q4227 – Q4249, 0598T and 0599T) as experimental.

7)    Effective 10/01/2020: New codes added (Q4249, Q4250, Q4254, Q4255) as non-covered.

8)    Effective 01/01/2021: Updated codes 19357, 19361, 19364, 19367, 19368, 19369, 19370, 19371 & 19380 as well as updated deleted codes that were eff 01-01-2017: Q4119, Q4120 & Q4129.