A bipartisan duo in the U.S. Senate is again pushing the Centers for Medicare & Medicaid Services to finalize the Sunshine Act, which requires medical device and pharmaceutical companies to file detailed reports on payments and gifts to physicians and other health care providers.
In an April 4 letter to CMS chief Marilyn Tavenner, Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) said they’re disappointed that CMS blew the October 2011 deadline for implementing the Sunshine Act.
"We request that the final rule on implementation be released no later than June of this year so that partial data collection for 2012 can commence," the senators wrote (PDF). "We also strongly urge CMS to work closely with stakeholders to finalize these rules to that they comprise a feasible approach to providing the valuable data that patients deserve."
A call for public comments closed in February and the rulemaking period is in progress, meaning the agency retreats behind closed doors while it promulgates the final rules into law. That in turn will leave companies with 90 days to implement their reporting procedures, meaning they could be required to begin reporting data to CMS during the 4th quarter.
That’s a tight timeline given the scope of the tax, Michaeline Daboul, president & CEO of compliance software provider MMIS, told MassDevice.com. Companies must first identify "covered recipients" – that is, the health care providers on their rosters that they’re required to report on. Then companies must aggregate every payment and transfer of value the law requires, link them to the appropriate recipient and feed the data into a system that will generate the necessary federal and state reports, Daboul said.
“They’ve got to put something in place that can actually correctly identify who they’re transferring that value to," she explained. "The bigger problem that people aren’t even thinking about right now is what happens when that information gets published in the public domain. Do you proactively show data before reporting?"
CMS strongly recommends that companies notify covered recipients that they’re about to be mentioned in a report, rather than waiting to resolve the inevitable mistakes and disputes until after publication. The onus is on industry to prove and verify each reported transaction, Daboul noted.
"Industry has no procedures or tools to do this. Companies large and small are all struggling, because they have no idea how they’re going to deal with this," she said. "Your customer is your bread and butter, so you should make sure your customers are happy and they absolutely know you’ve got their backs. It’s much easier for someone who knows proactively that their name is going to be up in lights. Every detail is going to be out there for the public to see, so it behooves industry to take a proactive approach to protect that customer relationship."
Unlike portions of the Affordable Care Act like the medical device tax that have met with stiff opposition from the private sector, the transparency measure has the support of industry. Voluminous responses from individual companies and AdvaMed during the comment period indicate their acceptance of the Sunshine Act, Daboul noted.
"No one is stating that this should be repealed. They’re accepting this, but they’re saying, ‘We think the interpretation of certain payments should be changed. The only other thing people are saying is, ‘We need more time.’"