As part of the FY 2009 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, the Centers for Medicare and Medicaid Services (CMS) is seeking comments on several proposed arrangements relating to the physician

self-referral law ("Stark Law"). In the proposed rule, CMS seeks industry input on proposals to resolve industry concerns related to the physician and entity "stand in the shoes" provisions that were initially published during the

finalization of the Phase III rules in September 2007. Additionally, CMS proposes regulatory changes to prescribe how the agency will determine the period of disallowance applicable to financial relationships that do not meet an

applicable exception to the Stark Law and corresponding regulations. CMS also requests comments on whether it should create an exception for "gainsharing arrangements." Finally, CMS uses the proposed rule to express

its concerns related to physician-ownership in implant and other medical device companies and seeks comments on how the agency should address these issues. Each of these issues is discussed more fully below and comments are due to CMS by 5 p.m. on Friday, June 13, 2008.

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