The Sunshine Act
Executing a clinical trial has become an increasingly complex endeavor, regardless of the size or market presence of the study sponsor. Concomitant with this rising complexity in trial execution are the increasingly stringent compliance regulations that clinical trial sponsors face in bringing their products to market. Chief among these is the Physician Payment Sunshine Provision (Sunshine Act) of the Patient Protection and Affordable Care Act.
Passed in an effort to allay concerns about conflicts of interest between physicians and the pharmaceutical and medical device industries, the Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies to begin recording all physician payments—including payments made for clinical trial research—starting in January 2012 and to report them starting in March 2013. (payments less than $10 are exempt from reporting until the aggregate annual total per company per covered recipient reaches $100, at which point all payments must be disclosed retroactively).
Grant payments for clinical trial research are typically made to investigative sites rather than to the physicians themselves. In addition, most sponsors engage with multiple CROs during the course of their clinical trials. These disparate data sources, combined with the manual processes many organizations rely on to track this crucial information, make it virtually impossible to collect and accurately report aggregate spend data in accordance with Sunshine Act requirements. Nevertheless, companies that do not comply with these regulations will face stiff penalties.
A Compliance Partner You Can Trust
With our unique domain expertise and innovative technology, Global Payment Services from CFS Clinical can help you withstand this heightened scrutiny of your aggregate spend data. Our streamlined processes and unique sponsor portal help you prevent reporting errors and avoid noncompliance penalties by allowing you to:
- Track investigator payments across all of your clinical trials
- Construct reports around both investigative sites and individual investigators
What’s more, our processes offer the agility you need to adapt easily to future changes and regulations.
Beyond the Sunshine Act
The Sunshine Act has also brought physician financial disclosure to the forefront. Incorporating a sturdy financial disclosure strategy in your organization ensures that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, thereby decreasing your financial and regulatory risk. The CFS Clinical Financial Disclosure Team can play an integral role in your financial disclosure strategy by:
- Working with your investigative sites to complete financial disclosure forms
- Auditing financial disclosure forms for consistency and compliance with 21CFR Part 54 and your internal SOPs
- Documenting potential conflicts of interest and ensuring data consistency and integrity by cross-referencing data back to Form FDA 1572
We built our Financial Disclosure Tracking System on the same platform as our Grant Payment Management System, allowing us to link primary and sub-investigator data directly to payment information. Now you can associate grant payment activity with every investigator involved in your trials, providing a more complete picture of health care practitioner spend activity.