11. Ambulatory Surgical Centers ("ASCs"), End State Renal Disease ("ESRD") Facilities, and Hospices

The Stark law deliberately excluded most ASC services from the definition of DHS.  Stark exceptions also exists for:

A. Implanted prosthetics and prosthetic devices and implanted DME furnished by the referring physician or a member of her group in a Medicare-certified ASC if:

  1. the implant is implanted during a surgical procedure performed in the ASC;

  2. billing and claims submission for the implants complies with all federal and state laws and regulations; and

  3. the arrangement does not violate the anti-kickback statute.


B. “EPO and other dialysis-related drugs” (defined as “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”) that meet the following conditions:

  1. they are administered to a patient in an ESRD facility, or, in the case of EPO or Aranesp only, are dispensed by the ESRD facility for use at home; and

  2. the arrangement for the furnishing of them does not violate the anti-kickback law or any laws or regulations governing billing or claims submission.


Note that this exception does not apply to any financial relationship between the referring physician and any entity other than the ESRD facility that furnishes the drugs.

Stark General Exception

Sources: 42 C.F.R. § 411.355(f) and (g)