New Device Pass-Through Alternative Pathway Applications RECELL System (the cost of the RECELL is $7,500) HCPCS code C1832 (Auto cell process sys) Effective beginning January 1, 2022, CMS is finalizing approval for device pass-through payment status for RECELL® under the alternative pathway for devices that have an FDA Breakthrough Device designation and have received FDA marketing authorization. AVITA Medical submitted an application for a new device category for transitional pass-through payment status for the RECELL® System (RECELL®) for CY 2022. According to the applicant, RECELL® is used to process autologous donor tissue into a cell suspension autograft that is then immediately applied to the surgically prepared acute thermal burn wound. The applicant stated RECELL® is a stand-alone, single-use, battery-powered device used to process and apply an autologous skin cell suspension. According to the applicant, RECELL® is a Class III medical device indicated for the treatment of acute partial-thickness and full-thickness / mixed depth thermal burn wounds and is not categorized as a skin substitute. HCPCS CODES REPORTED WITH RECELL Epidermal Autograft Procedures HCPCS Code
Short Descriptor
SI
APC 5054
15110
Epidrm autogrft trnk/arm/leg
T
15111
Epidrm autogrft t/a/l add-on
N
15115
Epidrm a-grft face/nck/hf/g
T
15116
Epidrm a-grft f/n/hf/g addl
N
15100
Skin splt grft trnk/arm/leg
T
15101
Skin splt grft t/a/l add-on
N
15120
Skn splt a-grft fac/nck/hf/g
T
15121
Skn splt a-grft f/n/hf/g add
N
15002
Wound prep trk/arm/leg
T
15003
Wound prep addl 100 cm
N
15004
Wound prep f/n/hf/g
T
15005
Wnd prep f/n/hf/g addl cm
N
5054
Split-Thickness Skin Graft Procedures 5054 5055
Surgical Preparation Procedures
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5054 5053
Summary of the CY2022 OPPS Final Rule
Software. Consulting. Education. Results.
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