Facing up to COI Sunshine

By Bill Sacks

On February 1st, 2013, the Centers for Medicare and Medicaid Services (CMS) released the final rules implementing the “Physician Payment Sunshine” provisions of the Affordable Care Act. These provisions, originally introduced as a separate bill by Senators Charles Grassley (R – IA) and Herbert Kohl (D-WI), will require Pharmaceutical and Medical Device companies to track and report all payments or “transfers of value” to physicians and teaching hospitals that exceed $10.00 (or essentially…everything).

The “Sunshine” provisions were designed to increase transparency in industry’s formal and informal relationships with medical providers. Ever since astute observers noticed that physicians could be influenced by financial considerations there has been concern that industry largesse could unduly influence research results, continuing medical education, prescribing, and other practice patterns. The thinking is, to paraphrase Justice Brandeis, “Sunshine is the best disinfectant.”

A public database of industry payments to physicians and teaching hospitals will go online by late 2014. This forthcoming transparency, on top of new COI regulations published by the NIH and Public Health Service that took effect last August, has resulted in significant movement on the part of hospitals and academic medical centers to put in place automated systems to collect and review conflict of interest disclosures and – just as important – to manage the conflicts uncovered through the disclosure process.

Technology to Improve COI Management

Compliance Officers and General Counsels in other industries should take note. Government contractors have obligations to identify and manage conflicts of interest under the Federal Acquisition Regulations (FAR). Many such contractors have tried to manage their COI obligations with paper surveys or simple generic online survey tools. These manual processes often collapse under their own weight, filling file cabinets or Excel spreadsheets with unusable, inaccessible data.

Newer, relational database tools are becoming more popular with organizations that need the ability to provide targeted survey questions to people with different reporting obligations, to direct COI survey responses to designated project managers and reviewers, to conduct detailed analysis on survey responses across projects, to produce customized reporting, and to maintain a database of archived responses.

Organizations seeking or managing federal contracts should periodically evaluate their COI management processes and systems to assess their effectiveness and to determine whether more up-to-date technological solutions could enhance operational efficiency.

(Bill Sacks is Vice President and co-founder of HCCS Inc., which provides online compliance training and workflow tools to organizations subject to federal regulations.  He can be reached at bsacks@hccs.com.)

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