Is “Sunshine” Curbing Clinical Research?

August 21, 2015
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

One of the worrisome aspects of the U.S. Open Payments transparency program is that it may discourage doctors from serving as investigators in clinical studies. The two-year-old program requires public disclosure of payments by drug and medical device manufacturers to health care professionals (HCPs) and teaching hospitals for conducting clinical trials, as well as for marketing and consulting activities. But an anomaly in the program credits to the principal investigator (PI) heading up a research site the full payment for managing and carrying out the study at that site.

One of the worrisome aspects of the U.S. Open Payments transparency program is that it may discourage doctors from serving as investigators in clinical studies. The two-year-old program requires public disclosure of payments by drug and medical device manufacturers to health care professionals (HCPs) and teaching hospitals for conducting clinical trials, as well as for marketing and consulting activities. But an anomaly in the program credits to the principal investigator (PI) heading up a research site the full payment for managing and carrying out the study at that site. Even though the PI receives only a fraction of that amount, the “transfer of value” posted by the Center for Medicare and Medicaid Services (CMS), which manages Open Payments, allots the full payment to the individual clinician.

Doug Brown, director of the data sharing & partnership group in CMS’ Center for Program Integrity, acknowledges that the data on payments to PIs seem confusing. He said at the recent CBI Transparency & Aggregate Spend conference in Washington, D.C. that his office is looking to revise listings for research projects to break out personal payments from total site funding, but such a change is not a high priority, and it won’t be easy. 

So far, pharma companies say they don’t see PIs dropping out due to Sunshine disclosures, although all parties continue to struggle to navigate the intricacies of the data tracking and reporting requirements. Yet a review of the Open Payments data for 2014, which CMS posted June 30, 2015, indicates a drop in spending on clinical research. A report by Tom Sullivan in “Life Science Compliance Update” finds that research payments to HCPs fell from $1.55 billion during the last 5 months of  2013 (all that was collected that year) to $1.06 billion during the same period in 2014 – a 32% drop. Meanwhile, there were only slight changes in transfers of value for other categories – food, consulting fees, travel.

The decline in research payments was fairly even over the 5-month periods and across the country, with the biggest reductions in states conducting the most research (Pennsylvania, California, Texas, Florida, New York), says the report. Contract research organizations felt the impact, as most sponsor payments to PIs went through “non-covered” CROs, which then have to report their payments to individual sites.

Lower payments could be due to sponsors moving more clinical studies overseas. Another possibility is that HCPs are increasingly employed by hospitals and health care systems and therefore have less time and flexibility to manage research projects. Or, Sullivan speculates that the change could reflect how “the added scrutiny of Open Payments reporting is a disincentive” for physicians to collaborate with biopharma companies developing new therapies.

An optimistic view is that the spending drop is a sign of progress in making clinical research more efficient – with shorter trials, faster enrollment, better retention, and more successful studies – to gain new product approval by the Food and Drug Administration. It will be interesting to see if full-year data  for 2015, which will be released in June 2016, confirms these trends.

Meanwhile, there’s hope that policy makers will find a way to make disclosure of industry payments to physicians for research services more realistic. Sponsors and physicians question whether research outlays should be part of the Sunshine program at all, as the larger aim of the program is to limit inappropriate patient treatment and reimbursement by exposing how industry payments to health professionals may influence prescribing. But policy makers have been concerned that companies may hide pay-offs to doctors through bogus “research” programs, or that physicians running clinical trials will become advocates for the test therapy, leading to over-prescribing and off-label use.

In fact, Open Payments listings for research are substantial. For 2014, a relatively few payments for research (585,079 of 11.4 million transactions) account for  about half the total money transferred to HCPs ($3.23 billion of $6.5 billion, $2.5 billion listed for a specific physician and $705 million to teaching hospitals). CMS acknowledges that research payments to physicians include funds for the institution or entity where the physician serves as the PI on the research project, which often cover overhead, research staff salaries, lab tests and other costs. But that note does little to prevent misinterpretation by the media or the public.