For the past year, the pharmaceutical industry has been bracing for the Sunshine Act, a provision of health care reform that requires drug makers to gather and report payments and gifts to physicians. The disclosures, which will be made public on a federal government web site, are being submitted in stages, but a preliminary round that recently ended suggests that drug makers are uneasy.
In a recent survey, drug makers came across payments that raised compliance concerns; expressed confusion about assigning financial values to certain items given physicians; encountered formatting problems that caused submissions to be rejected, and worry there will be discrepancies as more granular reporting occurs in the second phase that started this month.
“It’s been quite a struggle,” says Alice Dong, a senior consultant at Polaris, which advises drug makers on compliance issues, and queried 35 regulatory officers and attorneys two months ago. She notes that there is a “significant” amount of data to collect and report, since this marks the first time that a nationwide accounting has been required. Moreover, “there is a lot of room for interpreting” data.
The recently ended first phase involved reporting lump sum payments made to physicians between August 1 and December 31, 2013. The next phase, which began this week, requires drug makers to report complete payment details, such as specific physician names, payment dates and the type of payments made with specific amounts for the same time period.
In effect, the first phase was something of a dry run before the heavy lifting began. This may explain why nearly 47 percent of drug makers believe there will be significant to moderate differences in what they report to the U.S. Centers for Medicare & Medicaid Services. Similarly, there are concerns about the ability to verify information before reports are filed. In fact, 6% never validated their data.
Meanwhile, 32% were unsure about the information to include. Specifically, 23 percent were confused about properly identifying teaching hospitals and nearly 20 percent had questions about reporting meals provided to physicians who attended continuing medical education programs. Nearly 7 percent were uncertain about the value placed on medical journal reprints that were distributed to physicians.
Another cause for concern – nearly 44 percent reported that was a minimum of one to several specific payments made to health care providers that raised compliance concerns or at least required a “significant” follow up. And drug makers spent only 28 percent of their time in the first reporting phase verifying information about health care providers to be reported.
This last figure may rankle physicians, who have been advised by the American Medical Association to ask drug makers about data that is reported to the federal government and challenge some information, if need be. “There’s a lot of concern in the physician community about the way the information is reported and interpreted, and they are concerned it can be skewed,” says Dong.
Of course, the reporting, as they say, is a process and will require drug makers to refine their efforts as they proceed. And while the survey results may cause some to be disturbed over the extent to which the pharmaceutical industry will be able comply with the law, Dong maintains the survey suggests a growing awareness that improvement is needed. “The companies,” she says, “are taking this seriously.”
