Emanuele v. Medicor Associates, was presented to the United States District Court for the Western District of Pennsylvania as cross motions for summary judgment, and provides some guidance regarding the Stark requirements for bona fide personal service contracting arrangements.

The case originated as a whistleblower allegation that Hamot Hospital had not complied with all of the elements of the Stark personal service contract exceptions for medical directors’ contracts, and therefore that billing for the related services raised False Claims Act billing issues.

The Court’s opinion provides valuable guidance regarding:

  1. Allowing a “collection of documents” to satisfy the written agreement requirement.
  1. Acknowledging that fully disclosed retroactive effective dates are not fatal, and
  1. Providing actual examples of real world facts establishing the elements of materiality and scienter for FCA cases.

The opinion is attached below.

Emanuele v. Medicor