CHICAGO-Under intense and growing scrutiny of relationships between industry and physicians, academic health centers, medical professional organizations, and physician practices are grappling with how to guide physicians in their dealings with industry. For a specialty such as otolaryngology-head and neck surgery, which is heavily dependent on medical devices, this issue is particularly important to address.
Explore This IssueJanuary 2009
As we are a device-dependent specialty, the onus is especially on us as leaders in medicine to make sure we regulate our own house, said Udayan K. Shah, MD, Chair of the Medical Devices and Drugs Committee of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and a pediatric otolaryngologist-head and neck surgeon at Alfred I. DuPont Hospital for Children and Nemours Children’s Clinic-Wilmington in Delaware.
Speaking at a miniseminar on this topic at the recent AAO-HNS annual meeting, Dr. Shah emphasized the importance of physicians and institutions taking a proactive approach to compliance to protect physicians against liability issues, as well as to ensure their legitimate rights to compensation for services rendered.
Proactive Approach to Compliance
For Dr. Shah, who lectures widely on issues related to physician-industry relationships, full disclosure and transparency are the most important elements for physicians and institutions to keep in mind when dealing with industry. For any relationship that physicians have with companies, disclosure must be made within your institution, with your colleagues and peers, and with your patients, he said.
Another way to think of this, according to Gina Maisto Smith, JD, an attorney at Ballard Spahr Andrews & Ingersoll, LLP, in Philadelphia, is for physicians to treat a potential opportunity to work with industry as they would treat a patient-to triage the proposed relationship with industry with professionals who are familiar with the rules and regulations governing these relationships, such as an attorney or compliance officer.
Laying a sound foundation for a relationship with industry is critical, and, along with working with an attorney or compliance officer to ensure this, physicians can educate themselves about what issues to think about in dealing with industry.
According to Ms. Smith, there is a plethora of resources available for physicians and institutions on how to form a relationship with industry. The updated guidelines by the American Medical Association (AMA) are one essential resource (www.ama-assn.org/ama/pub/category/4263.html ) (see Table 1).