Physician-industry disclosure reintroduced
|Kohl and Grassley readdress Sunshine Act with new Congress. Image Source: Houston's Clear Thinkers|
The bill, which was first introduced last year in the 110th Congress, would establish a nationwide standard for reporting payments and posting them online—and would be regulated by the Department of Health & Human Services (HHS).
It includes language mandating disclosure of physician investments in and ownership of manufacturers. Manufacturers or group purchasing organizations that fail to report payments can be fined between $1,000 and $10,000 per infraction, up to a total fine of $150,000 per company annually, where failure to report is deemed an oversight. For “knowing failure to report,” the maximum of total fines goes upward to $1 million per company.
Beginning in April, 2011, companies would be required to report payments and other transfers of value for: consulting fees; compensation for other services; honoraria; gifts; entertainment; food; travel; education; research; charitable contributions; royalty or license fees; current or prospective ownership or investment interests; CME speaker fees and grants, along with anything else the HHS secretary deems necessary. Where payments are related to marketing, education or research specific to a covered drug, device, biological or medical supply, the company would be required to furnish that information, including the name of the therapy.
The legislation also specifies that it should not preempt state laws, allowing states to require further disclosures.
Separately, the Accreditation Council for CME reported it will begin disclosing whether or not individual accredited providers receive commercial support or advertising and exhibit revenue, along with the number of hours of medical education they report each year.