On September 13, 2011, the Office of Inspector General (OIG) responded to a letter from the Senate Finance Committee which addressed its concerns about the recent increase of physician-owned distributorships (PODs) and the potential adverse effects that these entities could have on the Medicare program and its beneficiaries. The Committee asked the OIG to assess the adequacy of the adequacy of the guidance that the OIG has issued in regards to the legality of PODs under the Federal Anti-Kickback Statute and whether further guidance or action is required to address the growing trend of these entities.
OIG will be initiating a review of PODs that will seek to determine the extent to which PODs provide spinal implants purchased by hospitals. This study will be nationally representative of hospitals that bill Medicare for these services, and OIG will review information from hospitals to determine the prevalence of PODs, what services PODs offer to hospitals, and whether PODs save hospitals money when acquiring spinal implants. In addition, OIG will look at Medicare claims data to analyze whether the identified PODs are linked with a high use of spinal implants. OIG will use the information from this study to determine whether or not to issue further guidance relating to PODs.
Current guidance from OIG establishes that the opportunity for the referring physician to earn a profit may be deemed illegal under the Federal Anti-Kickback Statute. However, OIG makes clear in the letter to the Committee that the Anti-Kickback Statute is an intent-based statute and different POD models raise different levels of legal concern. Therefore, OIG emphasizes the view that several of the legal questions raised by the Committee depend on the specific facts of the case (e.g. the terms under which a physician-owner may invest in the entity and the return on the physician’s investment).
Click here to view the letters sent between the Senate Finance Committee and the OIG.
For more information on compliance with the anti-kickback statute or other Medicare or health care regulations, please contact a Wachler & Associates attorney at 248-544-0888.