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US CROs to report payments to physicians

New rules to US ‘Sunshine Act’ also apply to CMOs

US contract research organisations (CROs) and contract manufacturing organisation (CMOs) must now declare any payments made to physicians, under new federal regulations impacting the pharmaceutical industry.

The Transparency Report and Reporting of Physician Ownership or Investment Interests, commonly known as the 'Sunshine Act', will require manufacturers of drugs, devices, biological or medical supplies to report payments made to physicians on an annual basis.

The new rules fall under the Patient Protection and Affordable Care Act (ACA) section of the act and apply to companies functioning within US health programmes Medicare, Medicaid or CHIP.

The ruling, released last week, also applies to both CMOs and CROs and will cover "payments and transfers of value", including consulting fees, honoraria, gifts, travel and entertainment.

From August 2013 companies will need to begin collecting data on payments made to physicians, which will then be submitted to the Department of Health and Human Services' (HHS) Centers for Medicare and Medicaid Services (CMS), by the end of March 2014.

"The intent of this law is to bring potential conflicts of interest to light with the goal of driving down healthcare costs," explained Scott Liebman, principal at Porzio, Bromberg & Newman, speaking to Forbes.

14th February 2013

From: Research, Regulatory

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