Even small payments given by pharmaceutical companies to CME providers are not escaping the eye of federal investigators poring over their grant records as part of an ongoing inquiry.
So said one of the aides to Sen. Charles Grassley (R-Iowa) last week at a national CME meeting during an update of the Senate Finance Committee’s investigation of the CME grant-making process.
The aide, Dan Donovan, said that responses to letters sent as part of the probe to two dozen pharma companies by the committee -- which Grassley (R-Iowa) co-chairs with Sen. Max Baucus (D-Montana) -- indicate that sales personnel “are going around the country” to certain regions and “doling out so-called educational grants in $100 increments. [This] raises additional questions in our mind about exactly what the intent is behind some of these educational grants.”
Donovan made the remarks to education professionals at the AMA’s 17th Annual Conference of the National Task Force on CME Provider/Industry Collaboration.
The first round of letters, sent last year and followed up in 2006 by a second round, show that most companies are adhering to prevailing rules, such as OIG’s 2003 guidance on separating marketing from education and the PhRMA Code on Interactions with Healthcare Professionals, Donovan said. “The problem is if you try to drill down and understand better what’s written on paper vs. what happens in practice…Despite the guidance that’s out there, we’re seeing that sales and marketing is still playing a significant role in how these companies are distributing education grants.”
The CME meeting came amid the government’s continuing focus on medical education partnerships, including efforts to root out off-label marketing. While the payments in some cases are small, the penalties can be great. US attorneys have recovered $1.5-$2 billion in the area of off-label promotion alone, as part of their investigation into fraud and abuse in the Medicare and Medicaid programs.
Donovan said the committee’s second round of letters was needed “because of some areas that we felt needed to be further explored.” They revealed that educational grants made to groups such as specialty societies or patient advocacy groups sometimes represent a large portion of the group’s funding. “This leads to questions about whether or not this type of financing compromises the approach of that group. When we see that, that leads to further inquiries.”
Pharmaceutical companies are responding to the crackdown by honing the way they evaluate providers. Education directors from AstraZeneca and Wyeth announced impending changes to their grant-making procedures that would help the firms assess provider competence.
“Wyeth doesn’t have a preferred or qualified provider program, but we do like to know who you are before we give you $5 million,” said Jennifer Spear Smith, PhD, MS, senior director, education strategy and compliance, Wyeth PES.
At the Baltimore meeting, providers also learned of impending changes designed to facilitate partnership with grantors. Pfizer is working to make its application process more productive. “In six months, it should be completely different,” said Mike Saxton, MEd, senior director/team leader, Pfizer Medical Education Department. It currently takes around 50 days to get an educational grant from Pfizer, and that’s too long. “We’re absolutely hoping to simplify things as much as possible.”
Like Wyeth and AZ, Pfizer is also introducing a request for education proposal process, Saxton said.
Pharma companies spent $1.1 billion on CME grants in 2005, a 4% increase from the previous year, according to figures submitted by accredited providers. As educational grants increase, so does federal scrutiny. Donovan said the Senate oversight shop is looking for “overt” problems with grants. “The crackdown on the pharmaceutical industry is not following the typical cycle,” he said. “In light of the tremendous settlements…that focus will remain.”