Medicare’s Sunshine Act changes could hit device makers in the pocketbook

Medicare regulators are looking for feedback on proposed changes to the laws governing transparency in financial relationships between doctors and healthcare companies, warning that the changes may represent a hefty new cost for medical device makers in particular.  The Centers for Medicare and Medicaid Services asked healthcare industry stakeholders to offer comments on four proposed modifications to the Physician Payment Sunshine Act, half of which are expected to have little to no practical impact, where the other half may mean a substantial upgrade to existing compliance programs.  “The most significant operational impact of the proposed changes would likely be on companies that manufacture, market, and/or distribute medical devices or medical supplies,” according to an alert issued by law firm King & Spalding’s FDA & Life Sciences Practice Group.  “This could require significant and expensive upgrades to tracking systems to enable such detailed reporting, and could be especially problematic for companies that manufacture, market, or distribute a large portfolio of devices or medical supplies.”

REFERENCE:  Mass Device; Arezu Sarvestani; 22 JUL 2014

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