LAST MONTH's final ruling regarding collecting data on industry payments to physicians from HHS's Centers for Medicare & Medicaid Services has several elements that are significant for medical education.
Perhaps most importantly, the regulations clarify that payments to a CME provider relating to an accredited CME program are not to be reported under a physician speaker's name if certain criteria are met.
But the reporting requirement remains in force for non-certified education. Fallout from the law has impacted the pool of speakers ever since the threat of a Sunshine law arose in 2007, said David Rear, managing partner at med ed company Advanced Clinical Concepts.
“It's reduced the ranks of speakers, particularly higher quality ones,” Rear said. “In response, folks who are further down the influence pyramid—busy local experts—are picking up the ball and running with it.”
These doctors like the income from partnering with companies. Regardless of disclosure rules, it's legal to do so as long as FDA and OIG promotional and anti-kickback rules are followed. The smaller speaker pools could increase competition between companies for doctors in certain specialties, Rear said.
Those companies whose bread and butter involves running dinner meetings could also suffer.
Meanwhile, the exemption for CME could give commercially supported CME a boost.
“This decision recognizes the adequacy of current protections against inappropriate bias in CME, and acknowledges CME's special role in educating physicians and improving patient outcomes,” the CME Coalition said in a statement.
Docs will have at least 45 days to review, dispute and correct information on them submitted to CMS by companies and GPOs. Violators can be fined up to $150,000 annually in civil penalties for failure to report. Knowing failure to report can cost companies up to $1 million annually.