"Sunshine" Goes Global

As the U.S. Open Payments system improves operations and resolves discrepancies, the emergence of widely diverse and contradictory transparency programs in Europe and other nations raises new challenges for pharma companies. Different landscapes for data disclosure, stakeholder identification, data reporting, timelines and privacy restrictions are emerging in Australia, Japan, Canada as well as Europe and the U.S.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has sought to establish a common transparency framework by adopting a voluntary code for companies to report transfers of value to health care professionals (HCPs). Drug and device makers are collecting payment information now for disclosure in June 2016. The specifics of the EFPIA program, though, differ from those in the U.S., and each European country appears to vary in how closely they follow the EFPIA model. For example, EFPIA permits companies to report R&D spending as a single total, and not for each principal investigator, as in the U.S.

In addition, European nations are enacting their own transparency laws, widening the range of reporting and disclosure policies. Some countries are establishing central platforms for posting payer information, while others rely on biopharma companies to disclose the information on their own websites. The French Sunshine Act was adopted in late 201, and  Portugal, Denmark, Romania have made similar moves, according to an August report on the “Global Transparency Movement” from Porzio LifeSciences. Taking a different tack, the United Kingdom recently issued a new “Sunshine Rule” that requires National Health Service hospitals and doctors to list all gifts and payments from pharma companies.

Such actions threaten to undermine EFPIA’s goal of establishing a consistent, unified self-regulatory approach to transparency reporting across Europe, the report notes. It remains to be seen if major pharma companies voluntarily report payment data, as EFPIA advises, and if health care professionals consent to data disclosure. Meager results may prompt additional states to enact their own transparency laws and drop the EFPIA model.

U.S. irons out wrinkles

Meanwhile, the U.S. Open Payments system appears to be addressing earlier problems, as  the Centers for Medicare and Medicaid Services (CMS), which operates the program, succeeds in identifying most physicians involved in the program, and manufacturers establish information systems able to track, manage and report validated transfer of payment data. CMS posted full-year data for 2014 on June 30, 2015, which covers some 11.4 million financial transactions that add up to $6.5 billion in payments from industry to “covered entities,” according to Doug Brown, director of the data sharing & partnership group in CMS’ Center for Program Integrity. Teaching hospitals, physicians and principal investigators in clinical trials divided the total amount fairly evenly.

Health professionals are disputing some, but not that many, of individual payment amounts, Brown reported at CBI’s August Transparency & Aggregate Spend Conference in Washington, D.C. CMS aims to enhance the review & dispute process by making it easier for manufacturers and recipients to communicate. But the medical community continues to criticize the Open Payments program, noting that flawed data encourages the public to draw “inappropriate conclusions” about unethical behavior, commented David Barbe, former chair of the American Medical Association (AMA) Board of Trustees.

His concerns are validated by news reports in July that highlighted the Big Spenders (largely marketers of new blockbuster drugs such as Gilead’s Sovaldi) and Big Recipients, which turn out to involve royalty payments, fees to prominent clinical trial investigators, and physicians involved in implanted medical devices.

Federal and state prosecutors say they have an eye on large recipients and are looking for evidence of intentional non-reporting by industry, which most likely will come from insider whistle-blowers. The Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS) plans to assess how well CMS oversees Open Payments reporting and if the data submitted is accurate.

Some Sunshine advocates seek to link Open Payment data to Medicare Compare postings on doctor and hospital reimbursement and to Medicare false billing reports. The combined information would make it easier to see whether physicians receiving hefty payments from industry also are top drug prescribers and if they have been involved in questionable billing situations.