The Sunshine Act - Open Payments
THE SUNSHINE ACT AND OPEN PAYMENTS CREATES STORM CLOUDS FOR MANY CLINICAL TRIAL SPONSORS
From ham-and-cheese sandwiches to investigator grant payments, any payment or transfer of value greater than $10 must be reported under the provisions of the Sunshine Act. And if the physician, hospital, or other covered recipient has received more than $100 during the year, any payment or transfer of value must be reported.
What’s more, the Sunshine Act, now known as “Open Payments,” requires clinical-trial sponsors to submit signed attestations as to the accuracy of the data they submit. These records can be audited up to five years after the date of payment. Since many companies’ Accounts Payable systems and Clinical Trial Management Systems (CTMS) are not integrated, clinical trial sponsors are facing significant challenges in addressing Open Payments’/Sunshine’s demand for transparency and accuracy. Many of them are outsourcing these payments to 3rd party providers with the technology necessary to remain in compliance with federal aggregate spend requirements, and growing global transparency requirements.
The Centers for Medicare & Medicaid Services (CMS) Sunshine Act, now known as “Open Payments,” promotes better payment processes and also mandates transparency with a national program for these payments. While the Open Payments program has created significant challenges for the industry, it is also disrupting antiquated payment processes and forcing the adoption of better practices for keeping clinical trials a viable business model for physicians.
Clinical studies today require a highly controlled and fully integrated global payment environment, which improves pharmaceutical sponsor compliance with the U.S. Federal Open Payments, state, and growing global aggregate spend reporting requirements. Moreover, the process must drive a physician’s satisfaction and ability to participate in research, which is critical to bring new drugs to market.