Many people in CME are breathing a sigh of relief that the Sunshine Act isn't a bad thing for them, but whether it's the white knight that comes to their rescue remains to be seen, say providers. The transparency rules, set to lay bare financial ties between physicians and pharma, spare some forms of medical education but not others, and they also spawn fresh questions.
The Centers for Medicare & Medicaid Services, part of HHS, issued its long-delayed final rule for collecting data on industry payments to physicians earlier this month. The regulations exempt reporting payments to an accredited provider of CME under a physician speaker's name, granted that certain criteria are met.
Had it been caught by Sunshine's glare, CME—already struggling from the decrease in commercial support (down by 39% from 2006 to 2011)—could have seen even more woes. While the issuance of the final rule settles some questions, it raises others. One of these is, will the Sunshine exemption pull CME back from the brink?
“Whether this causes manufacturers—pharma and biotech companies—to divert more funding to CME given the current downward trend I think is likely, but to what degree is hard to say,” said Bill Cooney, president and CEO of MedPoint Digital.
Along with tougher rules designed to stamp out bias and more press and political scrutiny, companies giving grants for certified CME would have had a blanket transparency rule to contend with, too, as earlier draft versions of the act had required.
Added David Rear, RPh, managing
partner at Advanced Clinical Concepts, “I think the Sunshine Act could
have continued the problem there but [through that] exemption they may
have saved themselves to some degree. Maybe industry will come back and
do some more funding.”
Such a reporting function "would have placed a significant burden on CME providers," said Kenny Cox, CCMEP, VP of Haymarket Medical Education's myCME. (MM&M is a Haymarket property.) Still, the decision by CMS to fall back on the current processes in place by the ACCME and other accrediting bodies, Cox said, "should help foster continued support of independent medical education for clinicians in the future."
Cooney cautioned that “There are still many, many barriers keeping commercial supporters from having really anything to do with CME. CME is more and more becoming this altruistic thing that pharma companies do. One could argue that Microsoft and Apple could just as well fund CME as Merck and Roche.”
Unlike its certified cousin, non-certified medical education didn't escape Sunshine's purview. The reporting requirement remains in force there, and fallout from the law has already impacted the pool of speakers, said Rear, whose company does promotional med ed.
“To date, it's definitely reduced the ranks of speakers, particularly higher quality ones,” he said, adding that in many cases it's their institutions that are worried about the visibility and are encouraging staff not to participate in activities where there are reportable transfers of value (TOVs). “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 and, regardless of the 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.
The question with peer-to-peer education is, could the split in physician participation in promotional med ed—between those at the higher levels of the KOL pyramid and others—widen further? Surveys suggest about half of physicians aren't aware of the Sunshine Act and the other half don't understand the essentials, said Cooney. “Lots of physicians are very sensitive about how they are viewed, and the more they know about the Act for promotional activities, the more they will be chilled [from participating],” he said.
What also remains to be seen is whether, for companies disclosing non-cash TOVs as part of their obligations under consent decrees with the federal government, the Sunshine Act will serve as the precedent. For example, “if they follow reporting requirements dictated per their corporate integrity agreements, are they going to say, ‘We will follow the Sunshine Act, because that's the federally legislated standard?'” posed Cooney, who called this a “huge question.”
What's more, when CMS publishes the first physician names in its forthcoming database, slated to appear September 2014, the profession could feel a second wave of fallout.
“What will the press do in terms of data-mining, in taking massive amounts of data on who's spending what and how, and on what to whom?” Cooney asked. “How will less friendly members of the political class handle it? And how will the public react? That's the last tsunami.”