As reported in this issue of AAOS Now, the Centers for Medicare & Medicaid Services (CMS) has released proposed rules under the Physician Payment Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act), which was designed to reveal potential conflicts of interest between drug, biological, and medical device companies and the physicians and teaching hospitals that prescribe and use them.
The law requires medical device, biologic, and drug companies to track all payments and transfers of value (TOV) to U.S. healthcare providers made on or after Jan. 1, 2012. Because CMS was late in releasing its proposed rules, however, the effective date will be delayed until after the final rule is published, probably in mid-February 2012.
As defined by the Sunshine Act, TOV include, but are not limited to, gifts, food and beverages, entertainment, consulting fees, and honoraria valued at $10 or more. Product samples that are not intended to be sold and are intended for patient use and educational materials that directly benefit patients or are intended for patient use are exempt from the reporting requirement.
Even though the effective date will be after the AAOS Annual Meeting, some companies with exhibits at the meeting may be tracking reportable transactions. Attendees who registered in advance and supplied their National Provider Identifier (NPI) number, a unique identification number assigned to each U.S. healthcare provider, will have that number embedded in the bar code data on their badge—it will NOT be printed on the badge. Exhibitors will be able to download the NPI information by swiping the badge through a lead retrieval system for these individuals.
Attendees who register on site or who did not supply their NPI information when they registered in advance may be asked for this information by exhibitors during the meeting. AAOS Annual Meeting attendees should understand that, although supplying NPI information is voluntary, the reporting of transactions by companies under the Sunshine Act is mandatory. Beginning in 2013, companies must report any payment or TOV with a minimum value of $10/payment or cumulatively $100/year or more to the Department of Health & Human Services (HHS) and publicly disclose the information on their websites.
For more information on the NPI at the 2012 AAOS Annual Meeting—including links to the HHS public registry of NPI numbers and background information on the NPI—visit www.aaos.org/npi; for more information on the 2012 AAOS Annual Meeting, visit www.aaos.org/am2012