By David Pyott
By Rachael Garrison
The Centers for Medicare and Medicaid Services (CMS) is continuing its efforts to quickly implement the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the "Sunshine Act."
The FDA published a draft of its financial disclosure guidelines, due to take effect by August , that parallel the healthcare reform law’s Sunshine Act.
The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.
Medical device companies should brace for some unintended consequences now that the Centers for Medicare & Medicaid Services rules on the Physician Payment Sunshine Act are set: the overhead costs associated with compliance were slighted in the government insurance agency’s reckoning.
Jonathan Kellerman, compliance and risk assessment manager at Pricewaterhouse Coopers, told MassDevice.com that the CMS underestimated the total overhead costs companies face from complying with the final Sunshine Act rules.