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Survey may fuel government interest in physician/manufacturer relationships
Investigations may focus on certain specialties, solo practitioners and medical ‘thought leaders.’
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According to survey results published in The New England Journal of Medicine, 94% of physicians have at least one relationship with a pharmaceutical or medical device manufacturer. While these results can be deceptive in that they include free drug samples and food furnished by company representatives in the physician’s office, the researchers report that one-third of physicians surveyed were reimbursed for costs related to professional meetings or continuing education, and more than one-quarter received payments for consulting, lecturing or enrolling patients in clinical trials.
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In the current enforcement environment for health care fraud and abuse violations, these results are likely to increase government concerns that physicians’ practice patterns are being influenced by manufacturers.
The survey found that physician group practices and solo practitioners were more likely than physicians practicing in hospitals to have relationships with drug and device companies, and they met more frequently with industry representatives. More specifically, group practices were three times more likely to receive industry gifts and four times more likely to receive compensation for services furnished to a manufacturer.
In addition to reporting the data, researchers offered their opinion as to the basis for these results, suggesting that group and solo practitioners have more flexibility in their prescribing choices than hospital-based physicians, which implicitly makes them more attractive targets for industry marketing efforts.
Specialty-specific
Furthermore, the study results indicate that manufacturers may focus on certain specialties and, in particular, individual physicians who are in a position to influence clinical practice guidelines and the prescribing habits of other physicians. One of the researchers, David Blumenthal, was quoted as saying, “It appears pretty clear that industry forms tighter relationships with doctors who are really the thought leaders, the ones who are likely to affect the behavior of other doctors.”
The study reveals that those perceived as “thought leaders” received payments from industry more frequently than other physicians.
These findings may provide federal enforcement authorities with even more incentive to investigate physicians’ financial relationships with industry.
In discussing the survey results, Blumenthal commented, “We have given physicians a lot of freedom to govern themselves and to voluntarily follow guidelines set by the profession. ... If they are unable to monitor and manage these practices, there will be increasing pressure on government to do it for them.”
Despite any conclusions drawn by researchers, many financial arrangements between physicians and industry are perfectly legitimate and, in may cases, integral to the development of medical technology and the improvement of patient outcomes. Yet, the link identified in the study between payments to physicians and their ability to influence clinical protocols and the practice patterns of other physicians could be taken by federal oversight and enforcement agencies as an effort by manufacturers to “buy” market share and increase sales.
“New reality”
Federal officials have indicated strongly that the medical device industry is going to be a top priority for future health care fraud investigations. During a recent Bureau of National Affairs (BNA) audio conference, Assistant U.S. Attorney Virginia Gibson called the anticipated increase in enforcement activity from the Department of Justice the “new reality” for medical device companies.
Five of the largest manufacturers of hip and knee surgical implants confronted this “new reality” in September 2007, when they each entered into an agreement with the federal government to resolve civil liability and to defer criminal prosecution arising from payments made to orthopedic surgeons under “sham” consulting agreements.
The U.S. Attorney’s Office for the District of New Jersey accused the manufacturers of using consulting arrangements, which required little or no actual physician work, to provide inducements to the surgeons to use a particular artificial knee, hip or reconstruction product. Under the terms of the agreements, the companies are required to post prominently on their respective Web sites the name, city and state of residence for each physician consultant and the yearly, aggregate amount paid to each physician for consulting services beginning in 2007.
Moreover, the manufacturers must include a provision in all new consulting agreements requiring physician consultants to disclose their financial ties to a company to their patients.
While it is the conduct of the manufacturer, which may have relationships with several practitioners, that usually captures the initial attention of the government, this survey shines a spotlight on the behavior of the physicians with whom they develop relationships.
To the extent the government draws the same conclusions from the raw data as the researchers of the study, the risk of an investigation may now be higher for physicians, especially high-profile physicians in surgical specialties who have financial relationships with device manufacturers. Physicians in these situations would be well-advised to structure arrangements with device manufacturers to comply with a safe harbor to the federal Anti-Kickback Statute.
At a minimum, physicians should make sure that the compensation paid under any such arrangement is consistent with the fair market value of the services being provided, and that it complies with applicable FDA regulations.
Further, arrangements that may adversely affect quality of care, historically, pose the greatest risk for prosecution. Therefore, physicians should be cautious about participating in the development of any clinical guidelines that could favor a product manufactured by a company with which a physician has a financial relationship. Moreover, physicians who begin consulting for a device manufacturer should carefully review any clinical guidelines affecting the use of the product to determine whether he/she had any involvement in their development.
For more information:
- Richard S. Liner, JD, MPH, can be reached at Arent Fox LLP, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-8972; e-mail: liner.richard@arentfox.com.
References:
- Campbell EG, Gruen RL, Montford J. A national survey of physician-industry relationships. N Engl J Med. 2007;26:356(17):1742-1750.
- In wake of agreements, device makers post payments to their consultants on Web. BNA Health Care Daily Report. Nov. 2, 2007.
- Medical device industry warned to expect more attention from Department of Justice. BNA Health Care Daily Report. May 25, 2007.
- Survey finds majority of doctors have relationships with drug, device companies. BNA Health Care Fraud Reporter. May 9, 2007.