Industry says Sunshine reporting recs will confuse, not clarify
At issue is concern that a list of payments will read like a list of payoffs. Industry groups say what's missing is the requirement that companies and doctors say why payments were remitted or received.
“We believe the work physicians do with pharmaceutical companies is of real value, but it takes good context, such as descriptions of research of educational outreach, for patients to understand that value,” said PhRMA spokesperson Kate Connors in an e-mail. Connors could not elaborate on the organization's comments which were still in draft phase at the time of publication.
The catch is that the current reporting requirements don't demand that the payments be explained, and the industry says it is vital to include this in the reporting standards. The Centers for Medicare and Medicaid Services is charged with interpreting the law and setting up the reporting requirements.
Coalition for Healthcare Communication's executive director John Kamp agrees with PhRMA and told MM&M in a phone interview that the current reporting rules will make every payment a questionable one. “These aren't bribes. These are fees for services provided,” he said. Kamp said the industry already has registries CMS could look to as templates, and cited drug maker Pfizer and medical equipment maker Stryker as examples.
Kamp's Coalition for Healthcare Communication and the CME Coalition are also bothered by the proposal to include continuing medical education courses in the registries. Kamp said CMS is skewing the legislation, which clearly exempts these courses from the reporting registries. “They don't have that right. It was wrong as a matter of law, it was wrong as a matter of policy,” he said.
Continuing medical education comes under the umbrella of indirect payments, which the Sunshine law excludes from reporting.
The CME Coalition said in its comments that rolling these courses into the non-exempt category will “create the erroneous impression that CME instructors have an inappropriate relationship with the organizations that support the programs.” The Coalition's comments, which it published on its website, noted that there is a built-in firewall in the med-ed category between the industry and healthcare practitioners. The Coalition said grantors cannot dictate curriculums, make their grants conditional, or advertise in educational materials, and that these safeguards maintain the integrity of the education effort and the participants.
Kamp said CMS should hold the comment period open longer and suggested it would take six months to hammer everything out -- for more comments to be fielded, the proposed rules modified, and a new comment period established. “Go forward with all the rest” he said, but added “there's plenty of time for them to get it right, before the registry goes public.”