"We need to have transparency" between physicians, the pharmaceutical industry, and device manufacturers, said American Academy of Family Physicians (AAFP) President, Ted Epperly, M.D. However, the latest version of the Bill (Physician Payment Sunshine Act of 2009 (PPSA 2009)) is overly onerous and creates the potential for "unanticipated and unintended consequences,"
The AAFP is calling for changes to a revised version of a physician payments bill that could place onerous administrative and reporting requirements on physicians.
Ted Epperly, M.D., of Boise Idaho, told AAFP News Now that he agrees with the overall intent of the PPSA of 2009 which addresses the issue of gifts to physicians from pharmaceutical companies and device manufacturers. But, he added, the current Bill poses undue burdens on physicians.
For example, the current version of the legislation would require pharmaceutical companies and device manufacturers to report any gifts made to physicians of more than $100 — an amount that really is too low for reporting purposes, Epperly said. The last version of the Bill, which was introduced in 2008, required the reporting of any gift of $500 or more, a more reasonable threshold, said Epperly.
According to the current version of the Bill, every payment made to physicians would have to be included in the aggregate calculation of reportable events. All of the gifts and reportable items would be posted online, and that information would be available to the public. Moreover, if a gift amount was posted incorrectly, physicians would not have the ability to correct that information, according to the terms of the legislation.
The Bill also classifies dozens of items as gifts, including consulting fees, honoraria, entertainment, education, research, current or prospective ownership or investment interests, and compensation for serving as a faculty member or as a speaker for Continuing Medical Education (CME) programs. In addition, it gives the Secretary of Health and Human Services the power to decide what other activities should be included as gifts.
"It gets into every little detail," said Epperly.
Epperly and others are concerned that the Bill's provisions could discourage physicians from participating in CME activities and would saddle physicians with an inordinate amount of paperwork. As written, the Bill also could force physicians to reveal proprietary information about grants and research activities.
"Our Bill only pre-empts state bills that do exactly the same thing," said Ashley Glacel, Press Secretary for Sen. Herb Kohl, D-Wis., a co-sponsor of the legislation. "This means that medical device and pharmaceutical companies only have to disclose the payment once, not 10 or 20 times."
Sens. Charles Grassley, R-Iowa, and Kohl introduced the first version of the Physicians Sunshine Act legislation in 2007. That Bill, like the current version, contained the same type of onerous reporting requirements. Grassley and Kohl revised the first iteration of the Bill in 2008 without reintroducing the legislation, eliminating many of the objectionable provisions in the process. Last month, the two reintroduced the Bill for the second time and included many of the provisions that were included in the 2007 version, prompting opposition from the AAFP.
"We want a return to the 2008 version," said Epperly. "It was the right thing to do but was less restrictive."
Epperly said the PPSA should strike a balance between transparency and openness on the one hand versus onerous reporting on the other.
"Somewhere in there, there is a balance," he said.