By Kelly M. Willenberg, MBA, BSN, CHRC, CHC, CCRP
From Compliance Today, a publication for HCCA members.
The Physician Payment Sunshine Act, a provision of the Affordable Care Act, was originally put in place to make financial relationships more transparent, give consumer’s information to make informed decisions about their healthcare, and create a link to the fraud and abuse laws. When it was rolled out this past fall, it was fraught with problems. By initiating the Act, institutions and the industry were required to have a methodology for verifying fair market value to their contractual analysis process and to develop standard operating procedures (SOPs) regarding those procedures.
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The industry itself is key to clinical trial research process, and they found themselves trying to develop a monitoring and tracking system for payments to sites or covered recipients. With varying sizes of sites, the tracking process was found to be complicated and time consuming. Language began to appear in contracts that sites would monitor and document all payments made by a research sponsor, and that they would transfer the documentation to the sponsor upon request. Sites have no obligation for reporting and sponsors cannot transfer liability to sites, so more confusion arose as sites began to question their role in the process.
Because the Act was planned to be “rolled out” in phases with differing requirements and varying timeframes, there were questions. During the implementation process though, it became apparent that there were challenges that industry, covered recipients, and the government would face. Some of those were anticipated, but much of what occurred was not.
Sites are now attempting to circumvent the issues they had not considered prior to the botched roll out. How does a site manage the review and verify or challenge reported payments? Who ensures that the physicians register in a timely fashion, so there can be a review of the reported payments? Since they cannot assume that the information posted is accurate, how do they perform detailed reviews to verify that the reporting is attributed to the correct category? During the roll out, it was discovered that many items were attributed to incorrect categories, such as travel and honoraria. Some data was reported under the wrong physician, and the list goes on. There are lingering questions for all involved in this process.
Finally, there are now questions from patients. Being prepared to answer those questions and who will answer them on the sites or physician’s behalf needs to be identified. It is still unclear how many patients will access the database and why they will. Patients and their families may misinterpret the information when they access it. Having an infrastructure and plan is now, more than ever, necessary to deal with the “unknowns” of the Sunshine Payments Act.