Sunshine Reporting Raises Concerns for Sponsors, Investigators

Pharmaceutical and medical products companies started on August 1, 2013 to collect data on payments and "items of value" provided to teaching hospitals and physicians, as required by the Sunshine provisions—now dubbed "Open Payments"—in the Affordable Care Act of 2010. The aim is to promote transparency in relations between industry and prescribers that could influence medical practice. Yet confusion over reporting requirements and methods for valuing services provided by clinical investigators is generating fears that data will appear inaccurate and inflated.

Due to a slow start in launching the program, the Centers for Medicare and Medicaid Services (CMS) gave manufacturers an extra year to set up comprehensive aggregate spend data systems to track all outlays. The first payment information won't be posted by the CMS Center for Program Integrity (CPI) until September 2014. It will differentiate "commercial" payments to physicians for consulting services and marketing activities from fees to health professionals and teaching hospitals for conducting preclinical and clinical research. However, physicians that manage large clinical trials fear they'll be linked to pharma promotion in any case. The medical community protested including research payments in the program, but policy makers held firm due to widespread beliefs that industry camouflages marketing activities under the guise of research—and because clinical trials involve most of the money.

Pharma companies have a long history tracking promotional spend, but the clinical end is very new, observed Manny Tzavlakis of Huron Life Sciences, at CBI's Sunshine and Aggregate Spend conference in August. A key issue in finalizing the Sunshine rules was to clarify that not all of a large research payment to a teaching hospital goes to an individual investigator. CMS will permit sponsors to provide "context" information to clarify the nature of a payment and who got what, explains Santanu Agrawal, Director of CPI's Data Sharing Group. But IT consultants fear that the larger totals still will be linked to individual investigators.

Research values

Another thorny issue is valuation of materials and goods provided to investigators, such as clinical supplies and equipment used in a study. The Open Payments program requires pharma companies to report the value of lab tests, equipment, and services covered by a research protocol or written agreement with the investigator or site. But CMS has provided little guidance on how to value these items or drug supplies and placebos. There's concern that disclosure of the value of clinical supplies could reveal whether a trial participant receives treatment or placebo and essentially "unblind" the study. And no one knows how to prorate the value of a refrigerator or diagnostic provided to a site for use in a limited study.

CROs, moreover, are struggling to meet the new reporting rules, as manufacturers have to report payments to investigators made through CROs and site management organizations. The problem is that each client of a CRO has its own reporting system. Quintiles has to use different templates for some 55 customers, noted Toby Ann Holetz of Quintiles at the CBI conference. And Jeffrey Truell of Covance reported large discrepancies in interpretation of what data is needed.

Getting the numbers right is vital for sponsors and research organizations because false filings can lead to stiff penalties and legal actions. Company executives have to attest that the data submitted to CMS is accurate, and mistakes can expose them to actions brought under anti-kickback and false claims statutes. As Mark Farrar of Navigant Consulting quipped, the Sunshine Act's main purpose is to provide another opportunity for plaintiffs' attorneys to file cases against pharma companies.

Meanwhile, doctors and hospital administrators fear that erroneous data will paint them as unethical practitioners in league with big pharma. Payment discrepancies could lead to queries from the IRS, which is expected to cross check if physicians properly report income received from industry. Some physicians say they will be more careful in serving as principal investigators or accepting consulting and speaking fees from manufacturers. That could further shift clinical research overseas, as payment reporting is not required for foreign investigators with no specific ties to US companies or research organizations.

Another concern is that confusion will arise from differences in reports on the Open Payments website and those posted by the National Institutes of Health, which recently adopted stricter, but slightly different, conflict-of-interest reporting requirements for federally funded researchers. Academic medical centers are concerned that in the end, all the publicly reported data bases won't match up "for completely legitimate reasons," explained Heather Pierce of the Association of American Medical Colleges. Transparency is supposed to increase public trust in research institutions, she noted, but without proper context, the payment information could erode that trust.