CMS has acknowledged that arrangements among providers to satisfy the Stark exceptions need not be created in a single document.  Although a single written document memorializing the key facts of an arrangement could provide the surest and most straightforward means of establishing compliance with the applicable exception, there is no requirement under the physician self-referral law that an arrangement be documented in a single formal contract.  Depending on the facts and circumstances of the arrangement and the available documentation, a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement of the leasing exceptions and other exceptions that require that an arrangement be set out in writing in any or all of the following exceptions.

  • Office and equipment leases
  • Bona fide employment agreements
  • Personal service agreements
  • Electronic health records

The full text of these proposal and CMS comments and explanations is available at: