stimulation of host healing without temporary persistence by acting as a biologic dressing. Pittsburgh, PA: Promethean LifeSciences; 2008. Garvey PB, Giordano SA, Baumann DP, et al. There are several products that provide intermittent topical oxygen therapy, usually once-daily. Most notably, it will be used for wounds resulting from chronic diabetic foot ulcers. Arthroscopy. Coons DA, Alan Barber F. Tendon graft substitutes-rotator cuff patches. J Wound Care. [website]. Porcine-derived polypropylene composite wound dressing (eg, Avaulta Plus), PRISMA matrix wound dressing, Pro3-C amniotic membrane, Promogran, Puracol, Puros Dermis, ReNu (amniotic membrane and fluid allograft), RHEO (BioStem Life Sciences, Inc.), Repliform, Seamguard, Solana allograft, Sonafine wound dressing, SportMatrix, SportMesh, Sterishield II Dual Layer Amnion Patch, Stravix, Viaflow Placental Tissue Matrix, StrataGraft, Surgisis (including Surgisis AFP Anal Fistula Plug, Surgisis Gold Hernia Repair Grafts, and Surgisis Biodesign), TissueMend, Tornier BioFiber Absorbable Biological Scaffold, Tornier Collagen Coated BioFiber Scaffold, Vaso Shield, Vendaje AC (BioStem Life Sciences, Inc.), Viaflow C Flowable Placental Tissue Matrix, Vitagel Surgical Heomstat, Xelma, X-Repair, XenMatrix, ACM Surgical Collagen, ACM Surgical Extra Advanced Collagen, ACM Surgical Extra Advanced Collagen Powder, AlphaGems, AltiPlast, Ambio Choice, AmnioCord, AmnioFill, Amnios, AmnyoFluid, Aquacel Ag, Arthrex Amnion Matrix, Arthrex Amnion Viscous, BioFix Flow Placental Tissue Matrix Allograft, Colla-Pad, CollaSorb, CollaWound, Collexa, Fluid GF, Grafix cryo-preserved placental membrane, GraftJacket RTM, InteguPly, Kerasorb Wound Matrix, Merigen, Ologen, Omega3 Wound, Omega3 Wound Matrix, Puracol Plus, Renuva, Restrata, Stravix PL, TheraForm and VersaWrap Tendon Protector, Bioinductive implant regeneten, Cellgenuity amniotic fluid, Cryotext and Dermis on demand (DOD) allografts, Myriad morcells, Paraderm dermal matrix, Mirragen Advanced Wound Matrix, per sq cm, Bio-connekt wound matrix, per square centimeter, NovoSorb SynPath dermal matrix, per sq cm, Phoenix wound matrix, per square centimeter, Kerecis omega3 marigen shield, per square centimeter, Skin substitute, fda cleared as a device, not otherwise specified, Topical hyperbaric oxygen chamber, disposable [TransCu O2] [EO2 Concepts], Alginate or other fiber gelling dressing, wound cover, sterile, Foam dressing, wound cover, sterile, each dressing, Autograft suspension, including cell processing and application, and all system components [RECELL Autologous Cell Harvesting Device (RECELL)], Microporous collagen implantable tube (NeuraGen Nerve Guide), per cm length, Microporous collagen implantable slit tube (NeuraWrap Nerve Protector), per cm length, Acellular pericardial tissue matrix of nonhuman origin (Veritas), per sq cm, Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex), OASIS ultra tri-layer wound matrix, per sq cm, MemoDerm, DermaSpan, TranZgraft or InteguPly, per square centimeter, Amniomatrix or biodmatrix, injectable, 1 cc, Architect, architect PX, or architect FX, extracellular matrix, per sq cm, Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm, Cytal, per square centimeter[Cytal Burn Matrix, Cytal Wound Matrix], Palingen or palingen xplus, per square centimeter, Palingen or promatrx, 0.36 mg per 0.25 cc, Cellesta Flowable Amnion (25 mg per cc); per 0.5 cc, Membrane Graft or Membrane Wrap, per sq cm, Axolotl Graft or Axolotl DualGraft, per sq cm, WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound Xplus, per sq cm, Human health factor 10 amniotic patch (hhf10-p), per square centimeter, MyOwn Skin, includes harvesting and preparation procedures, per sq cm, CoreCyte, for topical use only, per 0.5 cc, PolyCyte, for topical use only, per 0.5 cc, Celera dual layer or celera dual membrane, per square centimeter, Dual layer impax membrane, per square centimeter, Interphalangeal joint spacer, silicone or equal, each, Bilateral and unilateral primary osteoarthritis of first carpometacarpal [trapezio-metacrpal joint osteoarthritis], Bilateral and unilateral post-traumatic osteoarthritis and other bilateral and unilateral secondary osteoarthritis of first carpometacarpal [trapezio-metacrpal joint osteoarthritis], Primary osteoarthritis [trapezio-metacarpal joint osteoarthritis], Post-traumatic osteoarthritis, hand [trapezio-metacarpal joint osteoarthritis], Secondary osteoarthritis, hand [trapezio-metacarpal joint osteoarthritis], Spontaneous rupture of extensor tendons, upper arm and shoulder, Sprain and strain of rotator cuff (capsule), Musculoskeletal system [not covered for prevention of adhesions after orthopedic surgery], Corneal disorder due to contact lens [corneal wound], Injury of conjunctiva and corneal abrasion without foreign body [corneal wound], Other injuries of eye and orbit [corneal wound], M24.811 - M4.819, M25.211 - M25.219, M25.311 - M25.310, Other joint derangement, NEC, involving shoulder region, Unspecified open wounds of shoulder [open dislocation], Subluxation and dislocation of acromioclavicular (joint), Subcutaenous injection of filling material (e.g., collagen), Grafting of autologous soft tissue, other, harvested by direct excision (eg, fat, dermis, fascia), Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs 50 cc or less injectate, each additional 50 cc injectate, or part there of (List separately in addition to code for primary procedure), Grafting of autologous fat harvested by liposuction technique to face, eyelids, mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25 cc or less injectate, each additional 25 cc injectate, or part thereof (List separately in addition to code for primary procedure), Injection(s), platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed, Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed, Procuren or other growth factor preparation to promote wound healing, Nerve repair; with nerve allograft, each nerve, first strand (cable), Nerve repair; with nerve allograft, each additional strand (List separately in addition to code for primary procedure), Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular, Cymetra, injectable, 1 cc [for vocal cord paralysis - see CPB 253], Insertion of tissue expander(s) for other than breast, including subsequent expansion, Collagen nerve cuff (neuromatrix), per 0.5 centimeter length, Collagen matrix nerve wrap (neuromend collagen nerve wrap), per 0.5 centimeter length, Integra Flowable Wound Matrix, injectable, 1 cc, Porcine implant, Permacol, per square centimeter, Application of a modality to one or more areas; electrical stimulation, (manual), each 15 minutes, Electrical stimulation, (unattended), to one or more areas, for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care [if billed for Provant or MicroVas], Electrical stimulation, (unattended), to one or more areas, for wound care other than described in G0281 [if billed for Provant or MicroVas], Dermal substitute, native, non-denatured collagen (SurgiMend Collagen Matrix), per 0.5 square centimeters, Dermal substitute, native, non-denatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 square centimeters, 23405 - 23406, 24300 - 24342, 25260 - 25316, 26350 - 26502, 26510, 27097 - 27098, 27380 - 27400, 27650 - 27692, 28200 - 28262, Repair, revision, and/or reconstruction, tendon, 24357 - 24359, 26060, 27000 - 27006, 27306 - 27307, 27605 - 27606, 28010 - 28011, Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (Tenoglide Tendon Protector Sheet), per square centimeter, Injury to nerves and spinal cord [Codes not listed due to expanded specificity]. Rehder P, Pinggera GM, Mitterberger M, et al. There is a lack of evidence in the peer-reviewed medical literature to support it's clinical effectiveness. Ann Plastic Surg. Ease of use, safety, and efficacy of integra bilayer wound matrix in the treatment of diabetic foot ulcers in an outpatient clinical setting:A prospective pilot study. Favreau-Weltzer C, Bouchard D, Eleouet-Kaplan M, Pigot F. Response to Ratto et al., 'new Gore Bio-A() plug for anal fistula'. J Tissue Eng Regen Med. Armstrong, et al. 2020;9(1):23-34. Dunne JA, Wilks DJ, Rawlins JM. Suprathel Wound and Burn Dressing was cleared for marketing under the 510(k) processin May 2009 for "temporary coverage of noninfected skin defects, such as superficial wounds, under sterile conditions. Diabetic ulcers were 59 % more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). There was no effect on metabolic function, and subsequent necropsy analyses indicated tissue incorporation and blood vessel infiltration with no untoward tissue reaction, including encapsulation in each case. The amputation rate in the treatment cohort was 41.7 % less than that of the control cohort at 20 weeks (0.9 % versus 1.5 %, respectively). Use of cryopreserved, particulate human amniotic membrane and umbilical cord (AM/UC) tissue: A case series study for application in the healing of chronic wounds. Randomized phase II clinical trial of avotermin versus placebo for scar improvement. O'Meara S, Martyn-St James M. Foam dressings for venous leg ulcers. Extracellular matrix bioscaffolds for orthopaedic applications. 2002;28(1):81-82. ANZ J Surg. Quality of evidence: low." Comparative Effectiveness Review No. A prospective, randomized, controlled study comparing Gynemesh, a synthetic mesh, and Pelvicol, a biologic graft, in the surgical treatment of recurrent cystocele. Burns. J Plast Surg Hand Surg. U.S. Food and Drug Administration (FDA). Beniker D, McQuillan D, Livesey S, et al. Sbitany H, Kwon E, Chern H, et al. 2014;27(11). Plast Reconstr Surg. 2006;15(2):160-170. Bluebond-Langner R, Keifa ES, Mithani S, et al. 2022a;10(12):e4707. J Wound Care. In a prospective, randomized multi-center, pilot study, these researchers examined the safety and effectiveness of ASCS combined with compression therapy compared with standard compression alone (Control) for the treatment of VLUs. one of the skin application procedures described by HCPCS code C5271-C5278. 2013;2(4):e447-e451. Single-blind study of manuka honey in allergic fungal rhinosinusitis. 2011;2(3):495-501. #: OF1-000349-en-USVersion: FLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for Autograft OATS TechniqueFile Type: Ref. Wound Repair Regen. RM-2017. 2012;39(2):167-175. After complete epithelialization, the dressing separated and could be removed. Mean PAR at 12 weeks was 77.8% in the TheraSkin group compared with 49.6% in the SOC group (adjusted P = .0019). London, UK: NICE; January 2018. WoundEx membrane allograft consists of dehydrated and decellularized human amniotic membrane that has been processed with proprietary HydraTek technology. A novel treatment for venous leg ulcers. The use of PriMatrix, a fetal bovine acellular dermal matrix, in healing chronic diabetic foot ulcers: A prospective multicenter study. Hundeshagen et al (2018) conducted a prospective, randomized, controlled trial comparingMepilex Ag (M), a silver-impregnated foam dressing, and Suprathel (S), a DL-lactid acid polymer, in the outpatient treatment of partial-thickness burns in pediatric and adult patients. Itani KM, Rosen M, Vargo D,et al. Longas MO, Russell CS, He XY. 2015;135(1):29e-42e. Key variables were reported at 60, 90, and 180 days after the 1st product application. Farr J, Gomoll AH, Yanke AB, et al; ASA Study Group. Waymack P, Duff RG, Sabolinski M. The effect of a tissue engineered bilayered living skin analog, over meshed split-thickness autografts on the healing of excised burn wounds. 2015;19(2):253-257. Resistance to gapping as measured through normalized stiffness (N/mm/mm) was greater for the Tisseel group, Evicel group, and DuraSeal group versus the no-glue group only. 2017;14(6):993-1005. Wounds. Although it is less cost-effective than Omiderm, the significant increase of patient comfort makes this material represent a reliable and solid treatment alternative when dealing with partial-thickness burn injuries. Surgical outcomes of tympanoplasty using a sterile acellular dermal allograft: A prospective randomised controlled study. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. Available at: http://www.teibio.com/SurgiMend.aspx. InnovaMatrix AC is available for use in your office and wound care clinic.. InnovaMatrix AC is an important and innovative advancement in the treatment of wounds and is available for office use with the HCPCS code A2001. BJOG. Moreover, these researchers stated that these findings have potential implications for a paradigm shift in the approach used to achieve rapid and permanent closure of burn injuries. 2012;34(1):88-93. 2018;30(9):283-289. Wounds. Is canine eruption velocity affected by the presence of allograft within a repaired alveolar cleft? Cillo JE Jr, Caloss R, Miles BA, Ellis E 3rd. J Wound Care. Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Venous leg ulcers. K210580. There are few published reports of SurgiMend (Cheng & St. Cyr, 2012). Int Wound J. Efficacy of medical grade honey against multidrug-resistant organisms of operational significance: Part I. J Trauma Acute Care Surg. The authors concluded thatSuprathel represents a reliable epidermal skin substitute, with a good impact on wound healing and pain reduction in partial-thickness burn injuries. Abdominal wall reconstruction with concomitant ostomy-associated hernia repair: Outcomes and propensity score analysis. 510k no. The authors stated that this study had several drawbacks. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. In a retrospective, propensity matched-cohort study, Gurtner and colleagues (2020) examined data from 2,074,000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1,997) versus SOC alone (n = 1,997). Accessed June 30, 2008. London, UK: BMJ Publishing Group;June 2011. Amniotic epithelial stem cells: Salient features and possible therapeutic role. Cochrane Database Syst Rev. Moreover, these researchers stated that these findings were demonstrated in an animal model and may not directly correlate in humans. Harries RL, Luhmann A, Harris DA,et al. 1993;128(11):1227-1233. Efficacy of autologous platelet-rich plasma use for orthopaedic indications:A meta-analysis. 2013;10(5):502-507. Lavery LA, Niederauer MQ, Papas KK, Armstrong DG, Does debridement improve clinical outcomes in people with DFU ulcers treated with CDO? J Foot Ankle Surg. Perfusion was measured with hyperspectral imaging and transcutaneous oxygen. March 2016. Diagnoses or procedures may be subject to coding error, for which the extent of miscoding or under-coding that could result in bias is unknown, and may also result in measurement error in ICD-9/10 or CPT based variables. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. 2002;18(1):77-88, vi. Request to establish a new Level II HCPCS code to identifyCygnus Matrix. Wound Rep Reg. Carlson M, Faria K, Shamis Y,et al. Burns. 2019;7(8):e2371. J Neurosurg. 2017b;14(2):307-315. Chest wall resection and reconstruction for locally advanced primary breast cancer. TEI Biosciences Inc. Boston, MA. 2018;27(12):e387-e392. 2013;47(6):451-453. The use of acellular dermal matrices in two-stage expander/implant reconstruction:A multicenter, blinded, randomized controlled trial. Int Urogynecol J Pelvic Floor Dysfunct. Tong E, Martin F, Shelley O. Biobrane versus topical agents in the treatment of adult scald burns. EpiFix is a human amniotic membrane allograft which is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. The authors concluded that the findings of this study presented the largest reported series of patients undergoing a 3-level ACDFP by a single surgeon with close follow-up, and suggested that 3-level ACDFP utilizing a standardized modified Smith-Robinson technique had an acceptably high level of fusion in comparison to other modalities. Humanitarian Device Exemption No. Driver VR, Hanft J, Fylling CP, Beriou JM; Autologel Diabetic Foot Ulcer Study Group. Collagen nerve wrap. Edmonds ME, Foster AV, McColgan M. 'Dermagraft': A new treatment for diabetic foot ulcers. 2010;203(5):506.e1-e6. Ehrenreich M, Ruszczak Z. Update on tissue-engineered biological dressings. K071807. They are typically administered in an outpatient setting but may be administered inpatient or in the office setting. Reinard KA, Zakaria HM, Qatanani A, et al. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multicentre clinical trial in 80 patients. Inan I, Gervaz P, Hagen M, Morel P. Multimedia article. Lawin PB, Silverstein P, Still JM Jr. E-Z Derm a porcine heterograft material. 2009;9(1):11-14. Hirsch RJ, Cohen JL. Mdry R, Struyna J, Stachura-Kuach A,et al. Patients treated with CHSA received fewer product applications than DSS at 90 and 180 days (p < 0.05). Arthrosc Tech. 1987;159:127-136. Partial nephrectomy using porcine small intestinal submucosa. Specifically, the device processes a small, thin split-thickness skin sample 0.006-0.008 inch (0.15-0.20 mm) in depth to prepare an autologous Regenerative Epidermal Suspension (RES) for immediate delivery onto the wound surface. Surg Laparosc Endosc Percutan Tech. 2011;23(7):184-189. Short-term outcomes of trapeziometacarpal artelon implant compared with tendon suspension interposition arthroplasty for osteoarthritis:A matched cohort study. Plainsboro, NJ: Integra Life Sciences; 2008. These researchers stated that more studies with larger patient population are needed to examine the effectiveness of this therapy in chronic wound healing, and its potential to be used as an alternative to HBOT. Thomas S, McCubbin P. A comparison of the antimicrobial effects of four silver-containing dressings on three organisms. Foreign body reaction to artelon spacer: Case report. Mowry KC, Bonvallet PP, Bellis SL. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. Centers for Medicare & Medicaid Services (CMS). Hamilton NA, Porembka MR, Johnston FM,et al. J Pediatr Surg. Zelen CM, Snyder RJ, Serena TE,et al. Efficacy of fibrin sealant (human) (Evicel) in rhinoplasty:A prospective, randomized, single-blind trial of the use of fibrin sealant in lateral osteotomy. Limitations of this study include small sample size, omission of reporting certain important baseline variables and outcomes, and lack of blinding of persons assessing outcomes. H990002. It is comprised of native human amnion and chorion consisting of collagen types I, III, IV, V, VI, laminin, fibronectin, nidogen, and proteoglycans. Dis Colon Rectum. This product works as a barrier and covering for acute and chronic non-healing wounds and burn injuries. 2005;31(7):890-893. Wilgus TA. Prepared by the Health Services Research Unit, University of Aberdeen for the National Institute for Health and Clinical Excellence Interventional Procedures Programme. AETMIS 06-08. Bond JL, Dopirak RM, Higgins J,et al. 2018;8(1):e51-e55. J Hand Surg Am. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of thelower pole of the breast to reduce unwanted lift. Chalmers PN, Frank RM, Gupta AK, et al. UpToDate [online serial]. Treatment of a persistent iatrogenic cerebrospinal fluid-pleural fistula with a cadaveric dural-pleural graft.

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