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    Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Implants in an ASC

    Implants in an ASC – Current as of November 2017

    Stark exception related to both ownership/investment and compensation for implants in an ASC

    [No comparable safe harbor]

    Implants are furnished by an ambulatory surgery center and include, but are not limited to, cochlear implants, intraocular lenses, and other implanted prosthetics, implanted prosthetic devices, and implanted DME.


    The implant is implanted by the referring physician or a member of the referring physician's group practice in a Medicare-certified ASC with which the referring physician has a financial relationship.


    The implant is implanted in the patient during a surgical procedure paid by Medicare to the ASC as an ASC procedure.


    The arrangement for the furnishing of the implant does not violate the federal anti-kickback statute.


    All billing and claims submission for the implants does not violate any federal or state law or regulation governing billing or claims submission.


    This exception does not apply to any financial relationships between the referring physician and any entity other than the ASC in which the implant is furnished to, and implanted in, the patient.