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Court Rejects Urologists’ Appeal to Overturn Regulatory Changes to Stark Law

The Stark Law regulations are not without controversy, as an unsuccessful appeal by a group of urologists brought against the Centers for Medicare & Medicaid Services (CMS) illustrates.The Council for Urological Interests, a nonprofit association of physician-owned lithotripsy joint ventures, sought to overturn a 2008 CMS regulatory change to the Stark Law that made the urologists’ joint ventures illegal.

Though the District Court for the District of Columbia rejected the Council for Urological Interests’ latest appeal to overturn the Stark Law ban on physician-owned under arrangement service providers on May 24, it is expected that the underlying issues raised by the case will not go away. It is also expected that the urologists may appeal yet again. Tom Crane, an attorney in Mintz Levin’s Health Law Practice, recently authored an advisory entitled, Federal District Court Upholds Stark Regulation Ban on Physician-Owned Under Arrangement Service Providers, which details the District Court’s decision and its implications for physician-owned joint ventures affected by the 2008 regulatory change to the Stark Law.


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Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.