“If somebody is reporting about your behavior, you’d better keep track of your own records, which imposes the same burden on both the reporters and the people being reported on,” Ms. Tomar said. “That’s part of the concern. Now you’ve got to keep all these records – any affiliation you had, any conference where you were a speaker, and so on. It just gets to be extremely onerous in terms of both content and time for record-keeping.”
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ACEP News: Vol 31 – No 09 – September 2012That was one of the concerns expressed in a letter to CMS from a group of 50 national physician organizations and 43 state medical associations in response to the proposed rule. Among the other issues with the CMS proposal: the requirement that indirect payments must be reported even for CME in which the manufacturer has no control over content or speakers; the short 45-day window given to check the annual report and dispute any inaccuracies before the report is posted; and lack of a process for arbitrating disputes about the report’s accuracy.
That last item is a particular point of contention. In its proposal, CMS said the federal government should not “be actively involved in arbitrating disputes” between manufacturers and doctors, leaving them to resolve the issues themselves.
The physician groups called for CMS to establish an independent arbitrator or to use the total specified by the doctor on the website, with any disputed numbers flagged to notify the public. Those steps are important because, as the letter noted, while a few disputes with doctors won’t harm the manufacturer’s standing, “physicians may have their careers and professional reputations damaged as a result of one disputed report.”
The law does give doctors some breaks. For example, items such as product samples that are not intended to be sold and educational materials provided by manufacturers for patients do not have to be reported.
Overall, though, physicians will need to be far more aware than ever before of where the money and other items coming into their practice are actually coming from. And while that isn’t a bad idea, this particular way of putting it into practice may cause problems.
“I run a medical school, and we’ve changed our rules in terms of exposure of drug and device representatives to our residents and physicians,” Dr. Seaberg said. “They can’t accept any gifts over $50, and we have very strict rules now in terms of our graduate medical education and continuing medical education. And those are good. We support that. But the $10 threshold is way too low to have any meaning. The reporting has to be done within 45 days. The time period is short and it’s going to be a lot of paperwork, and frankly, there’s no oversight on that, either. Certainly, there are some good intentions here, but this goes way too far.”
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