The Advanced Medical Technology Association (AdvaMed), the largest trade association of medical technology companies, has updated its Code of Ethics on Interactions with Health Care Professionals (Code). The update, which is available here, will be effective Jan. 1, 2020. While the new version of the Code is not dramatically different from the previous version, companies should review the new version now, allowing time to implement any needed revisions to policies or training programs by the revised Code’s effective date.
The Code is designed to help medical technology companies comply with federal and state laws and regulations relating to the relationship between companies and health care providers (e.g., the federal Anti-Kickback Statute, which prohibits the exchange of anything of value in an effort to induce the referral of business that may be reimbursed by a federal health care program). The Code consists of voluntary, nonbinding guidelines, but it essentially describes “best practices” that are based on the current state of the law.
The revised Code includes a few new topics, as well as clarifications and revisions of existing provisions. The four new topics are:
- Jointly Conducted Education and Marketing Programs. This section emphasizes that companies should engage in joint educational or marketing activities with health care professionals only if there is a legitimate need for the company to do so (e.g., not to reward health care professionals for buying or prescribing the company’s products), and outlines controls a company should implement to ensure that such programs are not unlawful inducements.
- Communicating for the Safe and Effective Use of Medical Technology. This section describes how companies can disseminate “truthful and non-misleading” information relating to the use of their products, including information on both on- and off-label uses.
- Consigned Products. The revised Code expands the old section on demonstration and evaluation products to also account for the fact that consignment arrangements (e.g., products that are provided to a health care professional and to which the company retains title until the products are actually used) are permissible so long as appropriate controls are implemented.
- Company Representatives Providing Technical Support in the Clinical Setting. This section explicitly recognizes that company representatives can play an important role in the clinical setting by providing technical support, so long as (i) the representatives are only present at the request of a health care professional, (ii) the representatives comply with applicable hospital or facility policies and requirements, including patient privacy and (iii) the representatives are only providing technical support, and are not eliminating an overhead or other expense that the health care professional would otherwise incur while providing patient care.
In addition to the new sections, the revised Code clarifies and provides additional guidance on several topics contained in the previous version, including how companies should select and retain consultants and how and when companies can cover travel and meal expenses for health care professionals.
Although the effective date of the revised Code is several months away, medical technology companies should use the time to examine their current policies and procedures to determine how they need to be revised and updated to comply with the revised Code. Taft’s Health and Life Sciences attorneys can help you evaluate your current practices and will work with you to ensure you remain compliant.