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Anti-Kickback Safe Harbor

Returns on investments in 4 categories of ASCs-- (1) surgeon-owned ASCs; (2) single-specialty ASCs (e.g., those owned by gastroenterologists); (3) multi-specialty ASCs (e.g., mix of surgeons and gastroenterologists); and (4) hospital/physician-owned—provided all of the following standards are met:

  1. the ASC is certified as such under Medicare regulations;

  2. loans from the entity to investors for the purpose of investing are prohibited;

  3. investment interests are offered on terms not related to the volume or value of referrals;

  4. all ancillary services are directly and integrally related to primary procedures performed at the ASC and none are separately billed to Medicare or other federal health care programs;

  5. neither the ASC nor physicians practicing at the ASC discriminate against federal health care program beneficiaries; and

  6. each investor meets one of the following criteria:

a. a physician who is in a position to refer patients directly to the ASC and perform procedures for those patients;
b. a group practice that meets the requirements of the group practice safe harbor and that is composed entirely of physicians that meet the requirements of (vi.)(a) above; or
c. an investor who does not provide items or services to the ASC or its investors, is not employed by the ASC or any investor, and is not in a position to refer patients to the ASC or any of its investors.

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

Sources: 42 C.F.R. § 1001.952(r)

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