Two bills introduced in the U.S. Senate last fall, the Physician Payments Sunshine Act of 2007 and the Transparency in Medical Device Pricing Act of 2007, would amend the Social Security Act to provide the public with specific information related to medical devices. The bills would require manufacturers to supply detailed reports which would become publicly available on Web sites, as well as establish mechanisms of oversight and penalties for noncompliance.
The Physician Payments Sunshine Act of 2007, S. 2029, calls for device, drug or medical supply manufacturers paid under Medicare, Medicaid or SCHIP to provide quarterly electronic reports and annual summaries that detail a device manufacturer’s payments or other “transfers of value” to physicians. Reports would include physician names, business addresses, their affiliated facilities, and amounts and descriptions of payments or transfers of value. The Sunshine Act, sponsored by Sen. Charles Grassley, R-Iowa, with five cosponsors, calls for reports to be available to the public on a Web site that is “easily searchable, downloadable, and understandable.” The Sunshine Act reports would be quite similar to reports posted beginning last fall on Web sites of five companies that were required to disclose monetary and in-kind payments to consultants following investigation by the Department of Justice into their use of consulting agreements as inducements for physicians to use their devices.
The Sunshine Act defines “payment or other transfer of value” as “transfer of anything of value that exceeds $25, and includes any compensation, gift, honorarium, speaking fee, consulting fee, travel, discount, cash rebate, or services.” Included are products or items provided at less than market value, and participation in or materials provided for educational programs or seminars. Excluded are product samples intended for patients or transfer of anything of value to fund clinical trials or to physicians when they are patients and not acting in a professional capacity.
The Transparency in Medical Device Pricing Act of 2007, S. 2221, would require manufacturers of implantable medical devices to issue quarterly reports of their devices by name and category type, the inpatient or outpatient procedure in which they were used, the average and median sales prices of the devices, and other information.
Introduced by Sen. Grassley with cosponsor Arlen Specter, R-Penn., the Transparency
Act would require public accessibility of the information “in a matter that
is easily searchable, downloadable and understandable” on the Web site of the
Centers for Medicare and Medicaid Services.
Both bills were referred to the Senate Committee on Finance; further action
had not been taken at press time. Complete text and progress of the legislation
are available at https://thomas.loc.gov.