Stark Law: What Constitutes a "Collection of Documents?"

On March 15, 2017, the United States District Court for the Western District of Pennsylvania issued an opinion that sheds insight on how courts view the “writing” requirement of various exceptions under the federal physician self-referral law (Stark Law). The Court’s detailed discussion of the Stark Law in its summary judgment opinion in United States ex rel. Emanuele v. Medicor Assocs. provides guidance as to what may or may not constitute a “collection of documents” for purposes of satisfying a Stark Law exception.

The case was filed under the federal False Claims Act by whistleblower Tullio Emanuele, M.D. against the Hamot Medical Center of the City of Erie, Pennsylvania (Hamot); Medicor Associates, Inc., a local cardiology practice (Medicor); and individually named physician defendants who were affiliated with Medicor. Dr. Emanuele is a cardiologist who previously worked for Medicor. Although the government declined to intervene in the case, it did submit a Statement of Interest in the case record.

The case involves a number of arrangements between Hamot and Medicor, beginning with a “paired leadership model,” known as the Hamot Heart and Vascular Institute, and followed with a series of medical directorship arrangements. The particular arrangements at issue in the case included: (i) a directorship position in connection with the Women’s Heart Health Program (Women’s Heart Program), (ii) a chairman position for Hamot’s Department of Cardiovascular Medicine and Surgery (CV Chair), and (iii) six medical directorship arrangements that expired, but continued without formal renewals or extensions. The parties did not dispute that services were actually performed under each of these arrangements. Nonetheless, Dr. Emanuele alleged that the arrangements failed to meet a relevant Stark Law exception, primarily because the arrangements were not set forth in a valid writing.