EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/422211
EW FEATURE 48 The changing face of medical education December 2014 AT A GLANCE • Increased scrutiny of physician/ industry relationships could increase product costs and stifle innovation. • Current federal regulations focus on enforcing disclosure of financial relationships between physicians and industry. • Physicians and industry support transparency in financial relationships but are concerned that payments reported under the Sunshine Act could be misleading and taken out of context. by Lauren Lipuma EyeWorld Staff Writer ensure that they are not misrepre- sented by the system. Should all gifts be off-limits? Several states have passed laws limiting the monetary value of gifts that industry can provide to physi- cians, even when they are related to CME. Vermont bans industry from providing meals to physicians, and Minnesota prohibits any gifts worth more than $50, including food and drinks, even at CME events. Most states, however, do not seem to be moving in that direction. In 2008, Massachusetts passed a law ban- ning all industry gifts to physicians, including meals, but overturned the ban in 2012. The reversal could be due to the loss in revenue from med- ical conferences and conventions, Dr. Lane said, which could be the reason that other states have not followed suit. There is agreement among both physicians and industry representatives that transparency is an appropriate goal, but there is Randall Olson, MD, professor and chair of ophthalmology and visual sciences, and CEO, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, thinks that the costs associated with such detailed reporting could have unintended consequences. "One of my biggest concerns is that more and more we've got industry unwilling to invest in prod- uct development," Dr. Olson said. Coupling the high costs of reporting with the already difficult and expen- sive process of gaining FDA approval means that companies are investing less money in research and develop- ment of new products, he said. Not only are fewer products coming to the market, but costs of existing products are increasing, said Jim Mazzo, CEO of AcuFocus, Irvine, Calif. "I don't think the average con- sumer understands how much that [reporting] adds to the complexity and the cost of a company," Mr. Mazzo said. Increased product costs lead to increases in healthcare costs in general, he said, which could have a detrimental effect on quality of patient care. Many medical societies, includ- ing the American Society of Cataract & Refractive Surgery (ASCRS) and the American Academy of Ophthal- mology (AAO), have supported the Sunshine Act, but have expressed concern that payments listed in the public database will appear out of context, and could be misleading, inaccurate, or false. This has the potential to foster public distrust of physicians and industry, which could be counterproductive. "Transparency and disclosure is a good thing, it just needs to be done right," said Stephen S. Lane, MD, clinical professor of ophthal- mology, University of Minnesota, St. Paul. As the new reporting rules take effect, Dr. Lane advised that industry remain vigilant in ensuring that payments listed in the Open Payments database are accurate, and physicians should take care to Restrictions on industry/physician relationships: Where do we stand? Representatives from medicine and industry discuss current legal restrictions and their impact on quality of care T he Physician Payments Sunshine Act went into effect this year, highlight- ing government efforts to more closely regulate the financial relationships between phy- sicians and the pharmaceutical and device companies. Some regulations are necessary to ensure that physi- cians and industry interact in an ap- propriate manner, but experts think that overly strict rules have the potential to compromise the quality of continuing medical education and innovation in drug and device development. Efforts at the federal level have focused mainly on promoting transparency in industry/physician relationships. The Physician Pay- ments Sunshine Act, the most recent federal law to take effect, requires pharmaceutical and device man- ufacturers to report all payments made to healthcare providers that are greater than $10. These pay- ments are made public through the Open Payments program, an online, searchable database operated by the Centers for Medicare and Medicaid Services (CMS).