Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) are pressing the Centers for Medicare & Medicaid Services about missing a deadline for issuing regulations for the Physician Payments Sunshine Act, a part of the health reform law that requires 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 an Oct. 3 letter to CMS Administrator Donald Berwick. Grassley is ranking member of the Senate Judiciary Committee, and Kohl is the chairman of the Senate Special Committee on Aging.
The sunshine law requires manufacturers to report all payments to physicians, including consulting fees, honoraria, and travel and entertainment expenses. The act also requires the Department of Health and Human Services to publicly disclose on the internet the identity of the manufacturer, physician, and the drug or device associated with the payment.
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 to make that information public. The law required HHS to establish by Oct. 1 the procedures on how manufacturers submit information and how the information would be made available to the public.
In their Oct. 3 letter to Berwick, the two senators said that in a Sept. 23 conference call with Senate staff, CMS provided assurance that it had sent the proposed rule to the White House Office of Management and Budget for review.
Grassley and Kohl 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 Jan. 1, 2012, and must begin reporting this information to the government on March 31, 2013. Starting Sept. 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.
Grassley and Kohl said they developed the Sunshine Act after numerous investigations and hearings revealed that large sums of money were going to physicians for sometimes questionable purposes.
Representatives of CMS did not respond to a request for comment Oct. 4.
The letter is at http://www.grassley.senate.gov/about/upload/ Grassley-Kohl-CMS.pdf.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)