WASHINGTON – U.S. Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) are pressing the Centers for Medicare and Medicaid Services (CMS) on missing a deadline for drafting regulations for the Physician Payment Sunshine Act (Sunshine Act), a new law requiring public disclosure of the financial relationships between physicians and the pharmaceutical, medical device and biologics industries.
“Prompt federal guidance is urgently needed to ensure a smooth path toward increasing disclosure, eliminating conflicts and ultimately providing patients with the tools they need to make informed health choices,” Grassley and Kohl wrote in a letter to CMS Administrator Dr. Donald Berwick.
The Sunshine Act requires manufacturers to report all payments to physicians, including consulting fees, honoraria, travel and entertainment, and for the Department of Health and Human Services (HHS) to publicly disclose the identity of the manufacturer, physician, and the drug or device associated with the payment on the internet. Additionally, the law requires manufacturers and group purchasing organizations (GPOs) to report all ownership or investment interests held by physicians or members of their family, and for making that information public. The law required HHS to establish guidance on how manufacturers submit information and how the information would be made available to the public no later than October 1, 2011.
The Sunshine Act was developed by Grassley and Kohl after numerous investigations and hearings revealed that large sums of money were going to physicians for sometimes questionable purposes. Some of these payments were the subject of a federal criminal inquiry which resulted in $400 million in fines and legal costs paid by the major orthopedic medical device manufacturers. Ultimately, Congress passed the Sunshine Act as part of the health care reform law in response to growing concerns over industry payments to physicians and their potential negative effects on patient care and the need to restrain health care costs.
In their letter, Grassley and Kohl also asked why CMS failed to meet the statutory deadline and requested a timeline on establishing regulations.
Manufacturers and GPOs are required to start complying with the law by collecting payment data beginning January 1, 2012, and must begin reporting this information to the government on March 31, 2013. Starting September 30, 2013, the details of these payments must be made available to the public. Violations of the disclosure requirements can result in civil monetary penalties ranging from $1,000 to $100,000.
for the text of the letter.