Chan BCF, Campbell KE. Request to establish a single new Level II HCPCS code to identify two porcine-derived extracellular matrices also known as urinary bladder matrix (UBM), Trade Names: Cytal3L and Cytal6L. 2016;2:CD011255. J Wound Care. Snyder DL, Sullivan N, Margolis D, et al. TAG is applied directly to the wound after standard wound preparation and may be held in place using a secondary dressing. Repliform is processed by LifeCell Corp. and distributed by Boston Scientific Corp. Leng LZ, Brown S, Anand VK, Schwartz TH. 24. 2010;76(1):96-100. Rosen MJ, Denoto G, Itani KM, et al. Romanelli M, Dini V, Bertone M, et al. Adv Skin Wound Care. Bilayer Matrix Wound Dressing. Lancet. Krezdorn N, Knneker S, Paprottka FJ, et al. PDF 643 Amniotic Membrane and Amniotic Fluid - Blue Cross Blue Shield of 2002;137(7):822-827. Cheng A, Saint-Cyr M. Comparison of different ADM materials in breast surgery. 1993;32(3):263-268. Int Wound J. In this study 14/15 (93.3 %) of the wounds healed completely. Eur J Plast Surg. Another consideration was the application regimen used by the clinicians treating with BSA. 2004;62(4):489-496. Mid-term outcome of laparoscopic sacrocolpopexy with anterior and posterior polyester mesh for treatment of genito-urinary prolapse. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); 2010. A previously discounted flap now reconsidered: MatriDerm and split-thickness skin grafting for tendon cover following dorsalis pedis fasciocutaneous flap in lower limb trauma. The NICE Medical Technologies Guidance recommended that additional research was needed to address the uncertainties regarding the potential benefits of the ReCell procedure/system. Homicz MR, Watson D. Review of injectable materials for soft tissue augmentation. Foot care. Byrnes MC, Irwin E, Carlson D,et al. Use of small intestinal submucosa graft for the surgical management of Peyronie's disease. Parastomal hernia repair with acellular dermal matrix. A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Moore AM, MacEwan M, Santosa KB,et al. The use of growth factors in clinical practice. No adverse events related to TheraSkin were reported. Zelen CM, Serena TE, Gould L, et al. J Surg Oncol. Unite Biomatrix is packaged in a chemical solution and is available pre-fenestrated or non-fenestrated. Intra-articular injection of micronized dehydrated human amnion/chorion membrane attenuates osteoarthritis development. Sheth U, Simunovic N, Klein G,et al. Each matrix provides the same amount of human keratin proteins per square centimeter of product. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Patients who received either a bilayer cellular construct (BLCC), dermal skin substitute (DSS), or cryo-preserved human skin allograft (CHSA) were concurrently matched for Charlson Comorbidity Index (CCI), age, sex, and region, resulting in 14,546 study patients. Semin Pediatr Surg. Arthroscopic stabilization of acromioclavicular joint dislocation using the AC graftrope system. 2008;6(1). Arthroscopic interposition arthroplasty of the first carpometacarpal joint. Wallen J, Rao V. Extensive tricuspid valve repair after endocarditis using CorMatrix extracellular matrix. The Boston Scientific Web site promotes Repliform for pelvic floor repair and says it "is intended for the repair or replacement of damaged or inadequate integumental tissue such to repair enteroceles, rectoceles and/or cystoceles and for pelvic floor reinforcement.". Prevention and management of foot problems in people with diabetes. J Neurosurg. 2006;14(3):240-246. Does the addition of a nerve wrap to a motor nerve repair affect motor outcomes? The authors concluded that this animal study demonstrated the biocompatibility of ProLayer ADM. No unexpected tissue reaction or encapsulation was found. Accessed on February 11, 2010. SkinTE is manufactured from a harvested sample of the patients full-thickness skin, composed of viable skin cells and an organized extracellular matrix, with no additional cell or tissue source from another human (allogeneic) or (xenogeneic). Am J Clin Dermatol. J Cardiothorac Surg. Comparison of dermal substitutes in wound healing utilizing a nude mouse model. Kaartinen IS, Kuokkanen HO. J Hand Surg Am. Ann Plast Surg. Acta Orthop. 2013;26(4):164-167. Li HY, Xiao SC, Zhu SH,et al. 2012;25(12):543-547. Orbit. J Neurosurg Pediatr. Trapeziectomy with interpositional arthroplasty using acellular dermal matrix: Description of technique and early outcomes. Ostomy Wound Manage. Am Surg. 2011;98(7):925-934. It is intended for homologous use only. Pham CT. Bioengineered skin substitutes for the management of burns: A systematic review. The study focused on patient painscore, healing time, analysis of wound bed, ease of care, andtreatment costs. Shaharudin A, Aziz Z. PDF Cigna Medical Coverage Policy - AAPC Procenta is supplied in a single use vial containing one 200 mg placental allograft, providing coverage for up to a 6 cm2 wound surface area. 2006;192(6):705-709. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Burns. The authors concluded that the findings of this study suggested that TheraSkin may provide equivalent or superior outcomes to Apligraf while reducing costs. However, there is insufficient clinical evidence to support its effectiveness. Ann Surg. U.S. Food and Drug Administration (FDA). The marine Omega3 wound matrix for treatment of complicated wounds. Moseley R, Walker M, Waddington RJ, Chen WY. McCall TD, Fults DW, Schmidt RH. Coding Guides (28) 2023 Coding and Reimbursement Guide for the NanoScope Operative Arthroscopy System File Type: Ref. Bioactive prosthetic material for treatment of hernias. Stepney, Australia: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S); August 2006. Int Wound J. Hernia. Synovis Surgical Innovations. Appl Health Econ Health Policy. Gravante G, Sorge R, Merone A,et al. Liu DZ, Mathes DW, Neligan PC,et al. Support Care Cancer. Edison, NJ: MTF; 2015. 2012;21(5):236, 238, 240, 242-243. Plainsboro, NJ: Integra Life Sciences; 2008. 2012;(4):CD004123. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. The scaffold is gradually integrated with, and ultimately replaced by the body's own tissue. Biehl RC, Moore RD, Miklos JR,et al. Baltimore, MD: CMS;July1, 2022. London, UK: NICE; April 2001. Donated human tissue. XCellerate Amniotic Membrane Allograft delivers cytokines, proteins and growth factors to help regenerate soft tissue. Technology Assessment Unit, Office of Patient Care Services, U.S. Department of Veterans Affairs (VATAP). Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved amniotic suspension for the treatment of knee osteoarthritis. Arthrex Test Flashcards | Quizlet Canadian Agency for Drugs and Technologies in Health (CADTH). U.S. Food and Drug Administration (FDA). Arthrosc Tech. 2010;203(5):506.e1-e6. Giordano S, Garvey PB, Baumann DP, et al. 2010;25(4):378-382. After cohort matching, this data-set was not large enough to conduct this type of sub-analysis; future real-world matched-cohort studies looking at timely surgical intervention and recidivism are needed. Plast Reconstr Surg. Ophthal Plast Reconstr Surg. 2014;18(2):221-230. 2014;29(9):1125-1130. Dis Colon Rectum. 32. Gapski R, Parks CA, Wang HL. Rockville, MD: Agency for Healthcare Policy and Research (AHCPR); December 1994. Rockville, MD: FDA; February 3, 2006. It comes in a single size configuration as a hexagon patch with 2.5 cm sides, 5.0 cm in diameter, and total surface area of 16 cm squared. 2014;11(2):122-128. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence:A prospective randomized three-year follow-up study. 2013;(2):CD005083. However, there is insufficient scientific evidence regarding its effectiveness for tendon repair or for any other indications. Narins RS, Bowman PH. 2005;2(2):161-165. Ann Plastic Surg. Raghoebar GM, Schortinghuis J, Liem RS, et al. The Artelon CMC spacer compared with tendon interposition arthroplasty. Vowden P, Romanelli M, Peter R, Bostrm A,et al. Stern R, McPherson M, Longaker MT. Biomaterials. A simplified approach for arthroscopic repair of rotator cuff tear with dermal patch augmentation. Cultured epithelial autografts in extensive burn coverage of severely traumatized patients: A five year single-center experience with 30 patients. Caravaggi C, Francesco Grigoletto M, Scuderi N. Wound bed preparation with a dermal substitute (Hyalomatrix PA) facilitates re-epithelialization and haling: Results of a multicenter, prospective, observational study on complex chronic ulcers: The FAST Study. 2015;12(6):724-732. J Foot Ankle Surg. 2011;19 Suppl 1:s38-s48. 2015;12(6):646-654. The product is thawed in a sterile gloved hand for 5 minutes and cut and shaped to size prior to application following wound preparation. There was no statistical difference for the peak load at failure between any of the groups. J Dermatol. 2019;31(3):68-74. Arthroscopy. Colorectal Dis. PDF 2021 HCPCS Application Summary for Supplemental Coding Cycle J Shoulder Elbow Surg. Surg Innov. The above policy is based on the following references: Last Review Acellular nerve allografts in peripheral nerve regeneration: A comparative study. 2007;106(1):45-51. Neonatology. Diabetic foot problems. 2007;60(11):1214-1218. 2014;25:73-78. 2015;21(2):119-124. Fahrenbach EN, Qi C, Ibrahim O, Kim JY, Alam M. Resistance of acellular dermal matrix materials to microbial penetration. Agrawal V. Healing rates for challenging rotator cuff tears utilizing an acellular human dermal reinforcement graft. Available at: http://www.integra-ls.com/products/?product=274. Ferguson MW, Duncan J, Bond J,et al. Salgado W Jr, Rosa GV, Nonino-Borges CB, Ceneviva R. Prospective and randomized comparison of two techniques of staple line reinforcement during open Roux-en-Y gastric bypass: Oversewing and bioabsorbable Seamguard. A novel topical oxygen treatment for chronic and difficult-to-heal wounds: Case studies. Centers for Medicare & Medicaid Services (CMS). Chaby G, Senet P, Vaneau M, et al. Mowry KC, Bonvallet PP, Bellis SL. Relese (StimLabs, LLC) is a sheet skin substitute product comprised of dehydrated human amniotic membrane that contains non-viable cells and is intended for use as a selective barrier and to protect wounds from the surrounding environment for chronic and acute wounds including dermal ulcers and other defects. (2013) reported on a prospective study of 17 breast reconstructions in 12 patients with Surgimend. 2009;99:301-305. Stability is pleased to announce that our request for a Level II HCPCS code for AmnioCore Amniotic Membrane Allograft has been established . Thus, the results of this pivotal study would be considered hypothesis generating. Descriptive and multivariate regression analyses were used to compare wound outcomes. 2013;205(2):220-230. Tornier BioFiber Absorbable Biological Scaffold, and Tornier Collagen Coated BioFiber Scaffold, Veritas Collagen Matrix for use as an implant in the surgical repair of soft tissue deficiencies and all other indications, VersaWrap Tendon Protector for the management and protection of tendon injuries and all other indications, Viaflow / Viaflow C flowable placental tissue matrices, Vitagel surgical hemostat for wound healing and all other indications, Xwrap Amniotic Membrane-Derived Allograft. Wound Repair Regen. If conservative treatment fails, surgical intervention may be required. The ReCell biopsy site, on the contrary, were only 1 to 4 cm2 and produced little if no pain at all. Platelet-rich plasma and platelet gel: A review. K050355. Biglari B, Moghaddam A, Santos K, et al. 2011;21(6):783-793. Application of TruSkin is recommended weekly or bi-weekly for up to 12 weeks or until the wound is closed. Arthrex coding guides are designed to provide coding, coverage, and reimbursement information to internal and external customers who are involved in coding and reporting provider services. 2002;961:356-359. 2016;4(10):e1065. Another drawback was that the database did not include specific measures of vascularity or hemoglobin A1c (HbA1c), and this may have contributed to the differences in the healing rates observed. Holmes et al (2019) stated that STSG are the SOC for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. Baltimore, MD: CMS; December 20, 2007. 95-0652. The average TBSA (Total Body Surface Area) was 8.9% (1%-60%). Plast Reconstr Surg. Jones JE, Nelson EA. Ansaloni L, Catena F, Gagliardi S,et al. In a retrospective study, these researchers examined the safety and effectiveness of a biologically active cryo-preserved human skin allograft for treating wounds with exposed bone and/or tendon in the lower extremities. The combination of polytetrafluoroethylene mesh and titanium rib implants: An innovative process for reconstructing large full thickness chest wall defects. Urology. Attachment# 16.060 Laparoscopic repair of parastomal hernia using a porcine dermal collagen (Permacol) implant. 4.9x More Total Living Cells than claimed by Dermagraft. Moreover, these researchers stated that further investigation is needed to examine the effect of ASCS+compression on wounds evaluating the healing outcomes and the impact that the decrease in wound size has on pain and cost-effectiveness of the treatment. J Am Podiatr Med Assoc. Wangensteen KJ, Kalliainen LK. 2011;4(1):29-41. Clin Plast Surg. 1989;210(5):667-672. Robinson CJ. Rockville, MD: FDA; August 14, 2002. Vloemans AF, Hermans MH, van der Wal MB, et al. Human fibroblast-derived dermal substitute: Results from a treatment investigational device exemption (TIDE) study in diabetic foot ulcers. J Craniomaxillofac Surg. Successful grafting with EpiDex in pyoderma gangrenosum. Tendon augmentation grafts: Biomechanical failure loads and failure patterns. Markl P, Prantl L, Schreml S, Babilas P,et al. Some effects of a topical collagen-based matrix on the microcirculation and wound healing in patients with chronic venous leg ulcers: Preliminary observations. According to the manufacturer, Human Regenerative Technologies, LLC., WoundEx consists of placental connective tissue matrix intended to replace or supplement damaged or inadequate connective tissue (CMS, 2017). Clinical and in vitro responses of bilayered skin construct (graftskin) to meshing. 2022;75:103446. The authors concluded that this study provided evidence that the treatment of deep partial-thickness burns with ASCS resulted in comparable healing, with significantly reduced donor site size and pain and improved appearance relative to STSG. Until comparative studies of this product have been made available, a thorough evaluation of its safety and effectiveness can not be completed. 2000;53(3):281-287. 2015;157(3):507-511. 2016;1:59-62. Viaflow and Viaflow C Flowable Placental Tissue Matrices are pre-mixed, tissue matrix allografts, processed from human placental tissues. J Wound Care. Centers for Medicare & Medicaid Services (CMS). 2004;46(5):629-635. 2010;53(1):88-92. Int Wound J. Eplasty. 2002;11(9):335-341. 2021 Jun;47(4):838-846. TransCyte is applied to a wound using sutures or other fixation method based on the size of the wound being treated. Kokkalis ZT, Zanaros G, Weiser RW, Sotereanos DG. Ryssel H, Germann G, Riedel K, et al. A modified approach to component separation using biologic graft as a load-sharing onlay reinforcement for the repair of complex ventral hernia. Mayo Clin Proc. Brem H, Balledux J, Bloom T, et al. Serena TE, Yaakov R, Moore S, et al. Outcome of large to massive rotator cuff tears repaired with and without extracellular matrix augmentation: A prospective comparative study. Healthcare Common Procedure Coding System (HCPCS). Longaker MT, Chiu ES, Adzick NS,et al. Tong E, Martin F, Shelley O. Greer N, Foman N, Dorrian J, et al. Transfus Apher Sci. Am J Sports Med. To get a Q-code, you submit a description for your product and state why it's like another product that Medicare reimburses. Accessed January 18, 2008. A subsequent report of the intention-to-treat analyhsis of this same study suffers from the same limitations (Niederauer, et al., 2018). Successful treatment of two refractory venous stasis ulcers treated with a novel poly-N-acetyl glucosamine-derived membrane. 2012;99(10):1381-1388. They are available in 0.5 cc, 1 cc and 2 cc dose sizes. 1993;25(6):535-538. Jeon H, Kim J, Yeo H, et al. Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other. #: OF1-000180-en-USVersion: GLanguage: EnglishRevision Date: 01/03/2023 2023 Coding and Reimbursement Guidelines for the FiberTak AnchorsFile Type: Ref. Quality of evidence: low." Safety and efficacy of a dermal substitute in the coverage of cancellous bone after surgical debridement for severe diabetic foot ulceration. Alvarez OM, Makowitz L, Patel M. Venous ulcers treated with a hyaluronic acid extracellular matrix and compression therapy: Interim analysis of a randomized controlled trial. J Reconstr Microsurg Open. #: OF1-000345-en-USVersion: FLanguage: EnglishRevision Date: 02/27/2023 2023 Coding and Reimbursement Guidelines for the Syndesmosis TightRope Implant SystemFile Type: Ref. J Cell Physiol. HCPCS code for Romidepsin Injection, non-lyophilized liquid is needed because it is a single- . Raffa SJ, Benglis DM, Levi AD. J Trauma. Brown TJ, Alcorn D, Fraser JR. Absorption of hyaluronan applied to the surface of intact skin. A randomized controlled study. 2004;64(2):282-286. It is used in women and tendon coverage. Suprathel becomes transparent when applied, thus allowingclose monitoring of wound healing. . Medtech Innovation Briefing [MIB139]. Reda F, Kjartansson H, Jeffery SLA. Pichon Riviere A, Augustovski F, Ferrante D, et al. McCarron JA, Milks RA, Chen X,et al. A delayed type of ureteric injury developed after transobturator mesh procedure for massive prolapse. Available at: www.covidien.com/hernia. 2008;34(1):84-88; discussion 89-90. These are intended for use as a wound covering, surgical covering, wrap or barrier, application to partial-and full-thickness, acute and chronic wounds such as, traumatic and complex wounds, burns, surgical and Mohs surgery sites and diabetic, venous, arterial, pressure and other ulcers, including with exposed tendon, muscle, bone, or other vital structures. For placement of amniotic membrane using tissue glue . Hirsh F, Berlin SJ, Holtz A. Transdermal oxygen delivery to diabetic wounds: A report of 6 cases. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. A prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to sham therapy in the treatment of diabetic foot ulcers. Application Summaries and Coding Decisions Second Quarter 2021 Coding Cycle for Drug and Biological Products. 2014;148(6):3042-3048. Symphony is a bioengineered skin substitute made up of an extracellular matrix (ECM) and hyaluronic acid (HA). 2013;17(2):187-191. WoundFix XPlus Membrane and BioWound XPlus Membrane are supplied in single-use packaging, in 6 sq. Edmonds M, Bates M, Doxford M, et al. Plainsboro, NJ: Integra LifeSciences;2008. Arthrex Amnion matrix; ArthroFlex . Use of dermagraft, a cultured human dermis, to treat diabetic foot ulcers. A comparative histologic study. Donated human tissue. Kirsner RS, Eaglstein WH, Kerdel FA. Lee DK. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. 2018;6(5):e1763. The use of Biobrane() as a delivery method for cultured epithelial autograft in burn patients. Treatment of severe burn with DermACELL(), an acellular dermal matrix. In: BMJ Clinical Evidence. The first gauze change was appliedthe fifth day postoperatively, followed by regular wound inspectionuntil complete reepithelization. However, this was the largest study utilizing human cadaveric skin allograft as an adjunct therapy for lower extremity ulcers with exposed tendon and/or bone. Wound Repair Regen. Adv Skin Wound Care. Freymiller EG, Aghaloo TL. Currently, there is insufficient evidence to allow for proper evaluation regarding the effectiveness of this technology. After 16 weeks of treatment, patients in each group were evaluated on 4 criteria: O'Donnell and Lau (2006) examined if more "modern" complex wound dressings further improve the healing of venous ulcers over that with simple wound dressings. Buchberg B, Masoomi H, Choi J,et al. A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. 52. Blackman E, Moore C, Hyatt J, et al. Adv Skin Wound Care. (2015) found a lack of statistical significance for their primary endpoint, complete wound closure by 12 weeks. Curr Surg. J Wound Care. 2011;23(7):190-191. 2006;14(3):185-190. Graft choices for acetabular labral reconstruction. Guy JS, Miller R, Morris JA Jr, et al. The mean wound size in the diabetic foot ulcer group was 6.2cm2 ( 11.8) and 11.8cm2 ( 22.5) in the venous leg ulcer group. ReCell is a medical device that processes skin samples in the operating room into a cell suspension to be sprayed on or dripped onto a wound. Zerbib P, Caiazzo R, Piessen G,et al. 2012;40(5):1148-1154. Derwin KA, Baker AR, Spragg RK, et al.Commercial extracellular matrix scaffolds for rotator cuff tendon repair. Falanga V, Margolis D, Alvarez O, et al. 2001;54(8):659-664. 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. J Wound Care. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS). 2009;34(6):1029-1036. U.S. Food and Drug Administration (FDA). J Comp Eff Res. Arthroscopic superior capsular reconstruction with acellular dermal allograft using push-in anchors for glenoid fixation. 2016;37(1):e90-e95. Repriza can also be used in a range of applications to augment soft tissue irregularities and for implantation in irregularities such as a depression over the nasal bridge. 2019;45(4):772-782. Revitalon allografts are supplied in a single-sized package and provided in the following sizes: 1 cm round dot, 2x2 cm, 4x4 cm, and 4x6 cm. So K, McGrouther DA, Bush JA, et al. 2009;144(10):894-899. According to the manufacturer, Human Regenerative Technologies, LLC., WoundFix Membraneand BioWound Membrane are single-layer wound coverings for common wounds. It is intended for the protection and treatment of non-healing wounds and burn injuries. Narotam PK, Jose S, Nathoo N, et al. Mostow EN, Haraway GD, Dalsing M, et al. PDF Skin Substitutes - PacificSource Int Wound J. Burns. Osbun JW, Ellenbogen RG, Chesnut RM,et al. Wounds. J Vasc Surg. PDF Centers for Medicare & Medicaid Services (CMS) Healthcare Common Couture M. Does continuous diffusion of oxygen have potential in chronic diabetic foot ulcers? Arch Facial Plast Surg. One study for each of 3 targeted AWCMs (Apligraf [n = 130 treatment, n = 110 control]; Oasis Wound Matrix [n = 62 treatment, n = 58 control]; and Talymed [n = 22 treatment, n = 20 control]) met inclusion criteria. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); 2005. Scalp reconstruction using dermal induction template: State of the art and personal experience. Arthroscopy. Glat P, Orgill DP, Galiano R, et al. Collagen matrix for soft tissue reconstruction [website]. Werber B, Martin E. A prospective study of 20 foot and ankle wounds treated with cryopreserved amniotic membrane and fluid allograft. Immediate single-stage reconstruction of the breast utilizing FlexHD and implant following skin-sparing mastectomy. The study focused on the need for subsequent grafting, healing time, patient pain level, hypertrophic scarring and rate of infection. TissueMend (TEI Biosciences Inc., Boston, MA), marketed by Stryker Orthopaedics (Stryker Howmedica Osteonics, Kalamazoo, MI), is a remodelable collagen matrix derived from bovine skin intended for reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.