There is insufficient scientific evidence regarding the effectiveness of SurgiMend for use as an implant for the surgical repair of soft tissue deficiencies or for any other indications.
J Am Coll Surg. Am Surg. Coding Reference Guide AmnioRepair Allograft is a lyophilized placental membrane allograft that is aseptically processed to preserve the native extracellular matrix and endogenous proteins. Preoperative external tissue expansion for complex cranial reconstructions. Baltimore, MD: CMS; June 9, 2022. A comparative, long-term assessment of four soft tissue substitutes. Chadwick P, Acton C. The use of amelogenin protein in the treatment of hard-to-heal wounds. Garvey PB, Giordano SA, Baumann DP, et al. Open repair of isolated traumatic subscapularis tendon tears with a synthetic soft tissue reinforcement. 2014;37(9):608-614. 2014;208(3):480-484; discussion 483-484. Newport News, VA: Soluble Systems; revised April 22, 2011. Patients in group A, with a higher mean hemoglobin A1c at study outset, experienced a longer mean time to closure (29.50) days compared with group B (26.20 days). Int Wound J. 2018;15(1):114-122. ProMatrX ACF is supplied in liquid form in vials containing 0.25 cc, 0.5 cc, 1 cc, 2 cc, and 4 cc. 2004;64(2):282-286. 2 configurations available: Ambient temperature (Viaflow) and Cryopreserved (Viaflow C), 5-year shelf life at ambient temperature (Viaflow), The use of porcine-derived decellularized collagen products (e.g., Collamend, Cuffpatch, Pelvicol. Hannon CP, Yanke AB, Farr J. Amniotic tissue modulation of knee pain - A focus on osteoarthritis. Sade B, Oya S, Lee JH. 2016;104(7):1495-1503. Robson V, Dodd S, Thomas S. Standardized antibacterial honey (Medihoney) with standard therapy in wound care: Randomized clinical trial. Vermeulen GM, Slijper H, Feitz R,et al. 2007;33(2):221-229. Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. Zelen CM, Serena TE, Gould L, et al. Amniotic tissues contain many regenerative cytokines, growth factors, and extracellular matrix molecules including proteoglycans, hyaluronic acid, and collagens I, III, and IV. 2015;12(5):545-547. Tenenhaus M, Bhavsar D, Rennekampff HO. Baltimore, MD: CMS January 1, 2022. 2017;224(3):341-350. Public Meeting Summary Report. Control-treated and ReCell-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32 % with the use of ReCell (p < 0.001), establishing the superiority of ReCell treatment for reducing donor skin requirements. 2013;17(1):13-20. 2018;27(9):s30-s45. Diabetic foot ulcers treated with porcine urinary bladder extracellular matrix and total contact cast: Interim analysis of a randomized, controlled trial. The above policy is based on the following references: Last Review Final corrected distance visual acuity was better in subjects submitted to AMT. 2015;18(8):586-595. 2013;(10):450-455. Ferguson MW, Duncan J, Bond J,et al. Overview of the management of the severely burned patient. 2014;97(3):1048-1050. Barret JP, Dziewulski P, Ramzy PI, et al. Skull Base. TEI Biosciences. Tokish JM, Beicker C. Superior capsule reconstruction technique using an acellular dermal allograft. Armellino MF, De Stefano G, Scardi F, et al. Public Meeting Summary Report. Permacol: A potential biologic patch alternative in congenital diaphragmatic hernia repair. Sultan AA, Samuel LT, Roth A, et al. 2021 Jun;47(4):838-846. Agrawal H, Tholpady S, Capito A, et al. 2012;40(12):2771-2776.
PDF 2021 HCPCS Application Summary for Supplemental Coding Cycle 2015;21(2):119-124. 2006;14(3):240-246. 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. J Neurosurg. Mansfield, MA: Covidien; 2009. 2010;76(1):96-100. BioCartilage Extracellular Matrix Helping Surgeons Treat Their Patients Better - Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. 2015;41:177-188. 2011;17(4):CS47-CS51. The mean patient age was 70 years (range of 6 to 98 years). Baltimore, MD: CMS; December 15, 2003.
Skin and Soft Tissue Substitutes - Medical Clinical Policy - Aetna Thicknesses differ between Pro3-Placenta and Pro3-Cord for unique application use. 2007;177(2):604-608; discussion 608-609. 2012;37(8):1538-1542. Oasis Burn Matrix: HCPCS codes not covered for indications listed in the CPB: Q4103: Oasis Burn Matrix, per sq cm : ICD-10 codes not covered for indications listed in the CPB (not all inclusive): T20.011A - T25.799S: Burns: ParietexComposite (PCO) Mesh: HCPCS codes not covered for the indications listed in the CPB: C1781: Mesh (implantable) Early aggressive closure of the open abdomen. Hirsch RJ, Cohen JL. 2004;30(5):471-475. The multiple ECM sources and their varying collection of components (e.g., collagen, elastin, fibronectin, laminin, glycosaminoglycans [GAGs], proteoglycans, and other proteins) within in each ECM in XCelliStem provide a myriad of signaling molecules and numerous binding sites within their structure. 2015;24(3):128; 129-134. 2014;3(4):e487-e489, Hirahara AM, Adams CR. DiDomenico LA, Orgill DP, Galiano RD, et al. A clinical experience. 2014;97(5):e129-e131. 2011;40(3):238-243. There are no peer-reviewed published studies evaluating the safety and efficacy of Restorigin. Newport News, VA: Soluble Systems; revised August 10, 2011. Am J Sports Med. Dressings for acute and chronic wounds: A systematic review. #: DOC1-000544-en-USVersion: FLanguage: EnglishRevision Date: 02/23/2023 2023 Coding and Reimbursement Guidelines for Metal Compression FT ScrewsFile Type: Ref. Nonlinear and anisotropic tensile properties of graft materials used in soft tissue applications. The authors standard method of dressing pediatric extremity burn wounds consists of an antibiotic ointment or nystatin ointment-impregnated non-adherent gauze (primary layer), followed by rolled gauze, soft cast pad, plaster and soft casting tape (3M Scotchcast, St. Paul, MN). 2006;19(6):310-322. Preliminary experience with porcine intestinal submucosa (CorMatrix) for valve reconstruction in congenital heart disease: Histologic evaluation of explanted valves. K060952. El-Khatib HA, Hammouda A, Al-Ghol A, et al. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. The use of a bioactive skin substitute decreases length of stay for pediatric burn patients. 2012;40(10):2248-55. 2001;26(2):332-339. Injury. 2010;35(1):E25-E26. This allows for easy manipulation and results in a dependable, flexible allograft. Lower body mass index (BMI; p = 0.002) and non-plantar wounds (p = 0.009) were the only patient- or wound-related factors associated with complete healing at 6 months. Browne AC, Vearncombe M, Sibbald RG. Available at:https://www.triadls.com/about-innovamatrix-ac/. 2011;19 Suppl 1:s38-s48. 2008;21(8):370-374. J Am Col Certif Wound Spec. J Burn Care Res. Greer N, Foman N, Dorrian J, et al. Krezdorn N, Knneker S, Paprottka FJ, et al. Growth factors in surgery. 2013;17(5):609-611. Two alternative dural sealing techniques in posterior fossa surgery: (Polylactide-co-glycolide) self-adhesive resorbable membrane versus polyethylene glycol hydrogel. J Neurosurg.
PDF January 2020 Update of the Ambulatory Surgical Center (ASC - CMS Perfusion was measured with hyperspectral imaging and transcutaneous oxygen. Farr J, Gomoll AH, Yanke AB, et al; ASA Study Group. Surg Laparosc Endosc Percutan Tech. Valentin JE, Badylak JS, McCabe GP, Badylak SF. Raghoebar GM, Schortinghuis J, Liem RS, et al. 1989;15(1):52-54. 2009;22(4):161-166. It is supplied in a cassette containing two aseptically processed sheets, each approximately 5 inches by 7.5 inches. Prog Urol. 2015;31(8):1459-1465, Gilot GJ, Attia AK, Alvarez AM. Cheng AW, Abbas MA, Tejirian T. Outcome of abdominal wall hernia repair with biologic mesh: Permacol versus Strattice. Non-watertight dural reconstruction in meningioma surgery: Results in 439 consecutive patients and a review of the literature. The use of composite acellular allodermis-ultrathin autograft on joint area in major burn patients--one year follow-up. 2011;119(8):472-479. Hankins et al (2012) evaluated in terms of number needed to treat (NNT), the comparative clinical and cost efficacy of targeted advanced wound care matrices (AWCMs) as adjuncts to compression therapy for the treatment of chronic venous leg ulcers (VLUs) from the U.S. health care system (payer) perspective. 2023 Feb 15 [Online ahead of print]. 2018;5:1-4. 2015;1-7. It is "indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to: defect of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological surgical reinforcement including but not limited to, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical application, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons." Adv Skin Wound Care. Lattari V, Jones LM, Varcelotti JR, et al. Plast Reconstr Surg. Superior capsular reconstruction: Clinical outcomes after minimum 2-year follow-up. Burns. Cintron JR, Abcarian H, Chaudhry V,et al. Acta Obstet Gynecol Scand. Ann Plast Surg. 2008;51(6):838-843. J Cell Physiol. Outcome of the use of acellular-dermal matrix to assist implant-based breast reconstruction in a single centre. Talymed is provided as a 5 x 5 cm and 10 x 10 cm patch that should be cut to fit wound size. A bioabsorbable collagen nerve cuff (NeuraGen) for repair of lingual and inferior alveolar nerve injuries:A case series. LifeCell also produces Repliform, which seems to be the same product as AlloDerm (Snyder, et al., 2012). 2012;21(10):476, 478-80, 482. 2011;4(4):313-325. Int Wound J. Markl P, Prantl L, Schreml S, Babilas P,et al. Int Wound J. Fresh hypothermically stored amniotic allograft in the treatment of chronic nonhealing ulcers: A prospective case series. Commercial extracellular matrix scaffolds for rotator cuff tendon repair. Centers for Medicare & Medicaid Services (CMS). Is canine eruption velocity affected by the presence of allograft within a repaired alveolar cleft? Complications of alloderm and dermamatrix for parotidectomy reconstruction. Naughton G, Mansbridge J, Gentzkow G.A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers. REGUaRD is supplied as a thin (0.5mm) allograft, in a variety of sizes. 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. #: DOC1-001032-en-USVersion: ALanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for FastThread Interference ScrewsFile Type: Ref. Efficacy of fibrin sealant (human) (Evicel) in rhinoplasty:A prospective, randomized, single-blind trial of the use of fibrin sealant in lateral osteotomy. Acta Otorhinolaryngol Ital. #: OF1-000179-en-USVersion: FLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for the IntraOsseous BioPlasty TechniqueFile Type: Ref. The wound bed was prepared by using either rough debridement or dermabrasion excision. Wounds. Ann Surg. TransCyte is intended for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement. Even after successful surgery, these procedures often result in reduced joint mobility and tendon or ligament strength. Postoperative cervical cord compression induced by hydrogel dural sealant (DuraSeal). It consists of fully-stratified epithelial layer comprised of differentiated, multilayered, epidermal keratinocytes from a single human donor. AHCPR Pub. Slater NJ, van der Kolk M, Hendriks T, et al.
Billing and Coding: Amniotic Membrane Billing Guidelines for HCPCS Code PDF Skin Substitute Grafts Coding Reference Guide - Zimmer Biomet 2015;75(3):338-342. Stepney, Australia: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S); August 2006. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Seroma formation in rat latissimus dorsi resection in the presence of biologics: The role of quilting. Lullove E. Acellular fetal bovine dermal matrix in the treatment of nonhealing wounds in patients with complex comorbidities. Outcomes after abdominal wall reconstruction using acellular dermal matrix:A systematic review. Last reviewed December 2022. Efficacy of the anal fistula plug in complex anorectal fistulae. Breuing KH, Colwell AS. UpToDate [online serial]. Commonly used skin substitutes were porcine collagen (n = 397), bovine collagen (n = 78), Integra (n = 53), Hyalofill (n = 43), amnion/chorion-derived grafts (n = 40), and allogeneic epidermal-dermal composite grafts (n = 35). AmnioRepair is indicated for use as a biological barrier or wound cover. Jansen DA, Asgari MM, Atillasoy ES, Milstone LM. Randomized trial of porcine dermal sling (Pelvicol implant) vs. tension-free vaginal tape (TVT) in the surgical treatment of stress incontinence:A questionnaire-based study. In: BMJ Clinical Evidence. Surgeon. XCellerate is provided in a sterile sealed package and is intended for single use. Brem H, Balledux J, Bloom T, et al. Insufficient details of randomization was noted in this study. 2006;14(3):185-190. The Signature APatch is a cryopreserved, minimally engineered amniotic membrane allograft for homologous precision cut matrix for direct application as a would cover or physical barrier to acute or chronic wounds, including but not limited to venous leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds, burns, and wounds with exposed tendon, muscle, and/or bone. Kelechi TJ, Mueller M, Hankin CS, et al. 2009;18(6):S22, S24, S26, passim. At Week 14, VLUs treated with ASCS + compression had a statistically greater decrease in ulcer area compared with the Control (8.94 cm2 versus 1.23 cm2, p = 0.0143). 2008;33(6):893-899. (Weak; Low).". TruSkin addresses biological deficiencies in the wound, assists in epithelialization, and aids in preserving surrounding tissue. 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. 1989;210(5):667-672. Ehsan A, Lee DG, Bakker AJ, Huang JI. Armstrong DG, Meyr AJ. Failure of artelon interposition arthroplasty after partial trapeziectomy:A case report with histologic and immunohistochemical analysis. These researchers stated that blinded randomized control trials (RCTs) comparing the effectiveness of skin substitutes and traditional repair methods are imperative for establishing evidence-based guidelines on skin substitute usage following MMS. Wasiak J, Cleland H. Burns (minor thermal). Park MJ, Lee AT, Yao J. 2013;74(2):103-107. Stilwell and Delaney (2022a) noted that dermal acellular matrices may be used to replace or repair integumental soft tissues compromised by disease, injury or surgical procedures. Bergin SM, Wraight P. Silver based wound dressings and topical agents for treating diabetic foot ulcers. Martin BR, Sangalang M, Wu S, Armstrong DG. Safety and efficacy of Permacol injection in the treatment of fecal incontinence. Procenta (Lucina BioSciences, LLC) is an acellular, sterile, human placental-derived allograft. Centers for Medicare & Medicaid Services (CMS). 2009;34(8):1388-1392. Salivary gland tumors: Treatment of locoregional disease. Pain and assessments of scarring at the treatment sites were reported to be similar between groups. Arch Plast Surg. Use of duraseal in repair of cerebrospinal fluid leaks. 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. Clin Podiatr Med Surg. #: OF1-000177-en-USVersion: GLanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for the Corkscrew AnchorsFile Type: Ref. Statistical analysis was performed via analysis of variance followed by Tukey-Kramer post hoc pair-wise comparison when indicated. Int Wound J. 1995;16(3 Pt 1):317-320. Ostomy Wound Manage. Adelaide,SA: Joanna Briggs Institute for Evidence Based Nursing and Midwifery; 2001. 2014;97(3):1059-1061. The product is applied directly on or in the wound with a 20-23 gauge needle. A draft guideline by the National Institute for Health and Clinical Excellence (NICE) on the use of skin substitutes in the inpatient management of diabetic foot problems stated that the evidence for the clinical effectiveness of wound dressings in treating diabetic foot problems was of low quality and that only low-quality evidence on dermagraft and graftskin demonstrated positive effects on complete wound healing (at least 50 % wound closure). Kassolis JD, Reynolds MA. Borst HG. 2011;18(3):274-277. Dermatol Surg. 2018;15(5):731-739. 1998;19(6):531-537. 2014;23(7):355-357. During the healing process, the device is degraded and completely resorbed, leaving new tissue where scar tissue would normally be expected. Some treatment modalities, such as the use of negative pressure wound therapy versus simple bolster dressing, differed between wounds, but no statistical difference was noted between the treatments. 2007;33(8):966-972. 2007;31(10):1966-1972; discussion 1973-1974, 1975. matrix and endogenous proteins. 2013;205(2):220-230. Int J Oral Maxillofac Surg. 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. J Med Econ. The clinical and histological effects of Dermagraft in the healing of chronic venous leg ulcers. The average TBSA (Total Body Surface Area) was 8.9% (1%-60%). Specifically, Zenith Amniotic Membrane is indicated for the treatment of acute and chronic non-healing wounds inclusive but not limited to non-infected partial or full-thickness diabetic foot ulcers, venous leg ulcers, pressure ulcers, surgical wounds, and burn injuries unresponsive to conventional therapy. Veritas Collagen Matrix.