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Food and Drug Administration (FDA) approval of the RECELL System for the treatment of acute thermal second and third-degree burns in adult patients in January 2019, stating that the entire process of skin sample collection, enzyme solution preparation, and suspension spraying/application can take as little as 30 minutes and treat a wound up to 80 times the size of the donor skin sample. [12] Additionally, an article published in Europe PubMed Central states that the procedure takes approximately 30 minutes and is performed by a burn surgeon trained in how to use RECELL System, and does not require specialized laboratory staff
We are proposing to remove the deleted SA046 supply pack and replace it with two suppliesthe drape, sterile, three-quarter sheet (SB014) and the drape, towel, sterile 18in x 26in (SB019)for CPT codes 19000 and 60300
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CMS has proposed additional submission requirements for rebate reduction requests in the information collection request under OMB control number: 0938-NEW (CMS-10858)
