Is there a process for obtaining clarification concerning whether an arrangement falls outside of the Stark ban or meets an exception to the ban?
CMS has established an advisory opinion process under which parties to an arrangement can obtain a written determination from CMS concerning whether the arrangement constitutes a “financial relationship” under Stark II and whether the arrangement meets and exception. TYPES OF BUSINESS ARRANGEMENTS SUBJECT TO THE STARK II BAN In the final version of its Compliance Guidance for Individual and Small Group Physician Practices issued on September 25, 2000, the Office of Inspector General of the Department of Health and Human Services advised physicians to have all business arrangements that involve referrals reviewed by legal counsel familiar with the anti-kickback and Stark laws. Additionally, on June 8, 2004, the OIG issued a supplemental guidance for hospitals, which also focuses on physician and hospital relationships under Stark.
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