An important new piece of legislation that will dramatically affect our relationship with industry will most likely be implemented in the next few months by the Centers for Medicare and Medicaid Services: the Physician Payment Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act).
The proposed ruling will mandate that all payments by manufacturers to physicians must be disclosed— everything from lunch in your office to the thousands of dollars for research payments for running expensive clinical trials. Industry will take this provision very seriously, as the penalties for noncompliance are severe.
Supporters of the act will likely claim that disclosing all relationships between physicians and industry will curtail conflicts of interest concerning expensive drugs and technology. They will say that the public is better served by knowing the exact type of relationship that any particular institution or physician has with industry. There may, however, also be a downside in that the Sunshine Act may intimidate physicians from interacting with industry. So why would this be a problem for the public?
Although physicians are a critical part of the innovation process, the reality is that industry drives medical advancement ... period. Innovation in medicine is incredibly complex and expensive, and without industry pushing forward, advances would be few and far between.
Physicians play a crucial role in executing US Food and Drug Administration clinical trials on behalf of industry. Physicians are also needed to share the results of clinical trials to colleagues, and in an inverse relationship, physicians share their experiences with new drugs with industry.
At their core, the relationships between industry and physicians are beneficial to the public and are critical to efficient and effective technological breakthroughs, and curbing those relationships may be damaging. Although the objectives of the Sunshine Act are important, execution may be problematic, and the very public that the legislation intends to protect may suffer in the end.
Richard S. Kaiser, MD, is an Associate Surgeon
at Wills Eye Hospital, and an Associate Professor
of Ophthalmology at Thomas Jefferson
University Hospital in Philadelphia, and a partner
in Mid Atlantic Retina. He may be reached
at +1 800 331 6634; or via email at kaiserrick@aol.com.
Jonathan L. Prenner, MD, is an Assistant
Clinical Professor at the Retina Vitreous Center,
PA, Robert Wood Johnson Medical School of the
University of Medicine and Dentistry in New
Brunswick, NJ. He may be reached via e-mail at
jonathanprenner@hotmail.com. Drs. Kaiser and Prenner are the Co-chief Medical Editors of
New Retina MD, a unique publication written specifically for
retina specialists in their first 15 years of practice. The focus of
New Retina MD is not only on the clinical practice of medicine,
but also financial planning, updates in policy, and other
issues that have a significant effect on the lives of readers.
Read the latest issue and access all past issues at newretinadoc.com