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    Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- EPO and Other Dialysis-Related Drugs

    EPO and Other Dialysis-Related Drugs Furnished in or by an ESRD Facility  – Current as of March 2021

    Stark
    Stark exceptions to the referral prohibition related to both ownership/investment and compensation for EPO and other dialysis-related drugs 42 CFR 411.355(g)

    Anti-Kickback
    [No comparable safe harbor]

    The EPO and other dialysis-related drugs are furnished in or by an ESRD facility.  “EPO and other dialysis-related drugs" means certain outpatient prescription drugs that are required for the efficacy of dialysis and identified as eligible for this exception on the List of CPT/HCPCS Codes; and "furnished" means that the EPO or dialysis-related drugs are administered to a patient in the ESRD facility, or, in the case of EPO or Aranesp (or equivalent drug identified on the List of CPT/HCPCS Codes) only, are dispensed by the ESRD facility for use at home.

     

    All billing and claims submission for the EPO and other dialysis-related drugs 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 ESRD facility that furnishes the EPO and other dialysis-related drugs to the patient.