Summary of NEMA Code of Ethics
A New Code Of Ethics For Manufacturers Of Medical
Imaging And Radiation Therapy Equipment
By
Robert Britain
Clark Silcox
National Electrical Manufacturers Association
It is important for health care providers to be aware that a new code of ethics for manufacturers(vendors) of medical imaging and radiation therapy equipment went into effect on January 1, 2005. The National Electrical Manufacturers Association (NEMA) and its members prepared the new code to update recommended practices on interactions between suppliers of medical imaging equipment and health care providers in light of recent pronouncements by federal law enforcement authorities about compliance with the anti-kickback provisions of federal Medicare law*.
NEMA and its members recognized that adherence to ethical standards and compliance with applicable laws are critical to the medical device industry’s ability to continue its productive collaboration with health care professionals and institutions, which public policy favors.
The new code addresses the practices and relationships between health care providers and vendors and will change the interactions between the two. Several sections of the code are briefly summarized here.
While vendor-sponsored product training and education are essential, some aspects of these programs will change under the revised code. Training will be conducted in facilities conducive to effective transmission of knowledge, such as medical facilities or vendor training sites. Modest hospitality may be provided in the form of meals and receptions, but sporting event tickets, theater tickets or golf fees would not be acceptable. Vendors may pay for reasonable travel and lodging costs for health care providers to these programs, but not their guests.
The code also allows continued support of third-party educational conferences and provides guidance on how vendors can financially support such events. For example, vendors may provide educational grants, including grants for faculty expenses, but these monies can only go to the conference sponsors. None of this funding, according to the code, should be provided directly to the health care provider.
Sales and promotional meetings between vendors and health care providers are still recognized as important. But, under the new guidelines, hospitality provided by the vendor must be modest and subordinate to the purpose of the meeting. Reasonable travel costs may be paid to health care providers in limited circumstances, such as travel to see demonstrations of non-portable equipment. Guests or family members of health care providers may not have their travel cost paid for by the vendor.
It has long been acknowledged that health care providers may serve as consultants to vendors and, as such, provide a variety of bona fide services. The new code of ethics, however, stipulates that (1) these arrangements must be in writing and be signed by both parties; (2) compensation shall be at fair market value for the services to be rendered, and cannot be related to the volume of business generated by the health care provider or an affiliate of the provider; (3) travel expenses should be reasonable; and (4) hospitality provided should be modest and should not be in the form of sporting or entertainment tickets.
In another area, charitable donations by vendors may also continue, but they cannot be made directly to health care providers. Donations should be made only to charitable organizations. The code stipulates as well that donations should never be made if the proposed donation is, in any way, linked to a past, present, or future purchase, lease, recommendation, or use of a vendor’s products. Vendors are expected to develop processes for evaluating requests for charitable donations that ensures that such donations are separated from commercial considerations.
Research grants from vendors to health care providers will be allowed to continue under the revised code. However, the research must be legitimate and well defined in a written agreement. These agreements must be managed by vendor representatives who have no role in selling products or services to health care provider grantees. In addition, funding must not be linked to or contingent upon past, present, or future sales of a vendor’s product or services to the health care provider.
Conclusion
Although the new NEMA code of ethics is voluntary, it is anticipated that NEMA member companies(vendors) will incorporate the code into their internal compliance programs. It is hoped that health care providers will understand why it was necessary to publish the ethics code and why industry compliance with it is necessary for it changes the rules of engagement between health care providers and vendors. Health care provider organizations may wish to review their codes of ethics to determine if there are any serious deviations with the NEMA code.
This article is merely a brief summary of the NEMA code of ethics, and should not be used as a reference document. Those interested in a copy of the code may electronically access it at http://www.nema.org/prod/med/ and from this page, click on the link, “NEMA Medical Code of Ethics” to download the pdf file. To download this file directly, you may follow this link: http://www.nema.org/ethics/. Questions regarding the code may be addressed t Robert Britain, V.P. Medical Products and Clark Silcox, NEMA Counsel, National Electrical Manufacturers Association, 1300 N. 17th Street, Suite 1847, Arlington, VA 22209. Their phone and email contacts are at www.nema.org.
*U.S. Code : Title 42 : Section 1320a-7b