Ethics, HCPs and Industry: Learning from Transparency

In April 2009 PhRMA attempted to draw internal support around the PhRMA Code in an effort to establish guidelines for dealing with Health Care Professionals (HCPs). These voluntary guidelines were written to define boundaries for ethical interactions with HCPs. But PhRMA’s well intended efforts were eclipsed by federal and state legislators. The Physician Payments Sunshine Act was included in the Patient Protection and Affordable Care Act of 2009 (H.R. 3590, section 6002), which was signed into law on March 23, 2010. The new law requires full transparency and mandatory reporting by drug and medical device manufacturers regarding gifts and payments made to physicians and teaching hospitals.  A number of state legislative bodies also have passed legislation that mandates financial disclosure between HCPs and industry members.

How far has industry progressed on this issue? Have medical and device manufacturers closed the gap on the Sunshine Act and state requirements?   The eight companies that report online information on HCP contracted services gives us a window into the compliance complexities associated with the Sunshine Act.  While these companies may seem to be ahead of their peers, their current postings are mostly the result of a Corporate Integrity Agreement (CIA) rather than direct Sunshine Act compliance.  The posted data do, however, give us a glimpse into the future.

Sunshine Act information is scheduled to be posted to a public website in September 2013. The closest thing we have today to what the CMS site could look like is the ProPublica website (http://projects.propublica.org/docdollars/ ).  From this small slice of reported data we can see the challenges that lie ahead as systems, procedures and standards are put in place to manage the HCP contracting and reporting process under Sunshine Act requirements. Managing the process, collecting the data and reporting the information will be no simple task. 

Today, as a result of this legislation, numerous back-end industry solutions are being developed to meet Sunshine requirements. It is not clear whether the industry as a whole will stand ready to meet the Sunshine Act timelines. It is fair to say that current manufacturer efforts toward systems development is widely varied with a major focus on enterprise data management.  But what can be learned from the broader landscape? Will companies move beyond their internal preoccupation with data to find ways to gain insight into best practices that help improve industry interactions with HCPs?