Advanced Medical Technology Association (AdvaMed) is a trade association for companies producing medical devices, diagnostic products, and health information systems. Relationships between AdvaMed member companies and Health Care Professionals (HCPs) are vital to the development of medical technologies, their safe and effective use, and medical research and education. However, these relationships can also create risk under state and federal laws. To avoid such risks, AdvaMed created the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (AdvaMed Code) in 1993. Recently, AdvaMed has announced revisions to its code to clarify and refine its discussion of interactions between HCPs and AdvaMed member companies. Revisions become effective January 1, 2020.
AdvaMed Code: New Sections
Jointly Conducted Education and Marketing Programs: Companies who partner with HCPs to conduct joint education and marketing programs, which must be designed to highlight medical technology and an HCP’s ability to diagnose or treat medical conditions, should comply with the following guidelines:
- A legitimate need must exist for the company to engage in the activity for its own educational or marketing benefit;
- Companies should establish controls to ensure that the decisions to engage in such arrangements are not an unlawful inducement;
- Jointly conducted education and marketing programs should be balanced and should promote all parties;
- All parties should make equitable contributions towards the activity and costs of the program; and
- The arrangement should be documented in a written agreement.
Communicating Information for the Safe and Effective Use of Medical Technology: Communicating information about unapproved or uncleared (off-label) uses for approved or cleared products should be in accordance with the code’s established principles. These principles recognize the industry’s responsibility to communicate medical and scientific information to achieve positive patient outcomes and to support public health. The code’s off-label communication guidelines reflect recent judicial opinions affirming First Amendment protections for truthful and non-misleading off-label speech. Industry appropriate communications can include:
- Proper dissemination of peer-reviewed scientific and medical journal articles, reference texts, and clinical practice guidelines;
- Presentations at education and medical meetings; and
- Discussions with consultants and HCPs to obtain advice or feedback.
Companies should evaluate and implement these guidelines in light of existing FDA laws and the HHS/OIG instruction on off-label communications.
Company Representatives Providing Technical Support in the Clinical Setting: Company representatives may play an important role in the clinical setting by providing technical support on the safe and effective use of medical technology. For company representatives providing technical support, representatives should . . .
- Be present in the clinical setting only at the request of and with supervision by an HCP;
- Be transparent that they are acting on behalf of the company in a technical support capacity;
- Not interfere with an HCP’s independent clinical decision-making;
- Comply with applicable hospital or facility policies and requirements; and
- Not eliminate an expense that the HCP should otherwise incur while providing patient care.
AdvaMed Code: Consolidations and Clarifications
Cornerstone Values: Innovation, education, integrity, respect, responsibility, and transparency form the basis of the updated AdvaMed Code. It directs medical technology companies to review all interactions with HCPs in light of these values and to avoid interactions designed to circumvent the code.
Scope and Applicability: The updated AdvaMed Code applies to all interactions regardless whether an interaction occurs outside the United States (such as at a conference or other event). The updated code clarifies that for companies with multiple lines of business, the code applies only to the company’s interactions linked to medical technology, including all interactions related to combination products that include a medical technological component (i.e., combination of biologic devices and drug products).
Consulting: Although the content regarding consulting remains mostly unchanged, the updated AdvaMed Code adds clarifying language defining what constitutes a “legitimate need” for the consultation. According to the code, a legitimate need arises when a company requires the services of an HCP to achieve a proper business objective. However, engaging an HCP for the purpose of generating business directly from such HCP (or health care provider affiliated with the HCP) is not a proper business objective.
The AdvaMed Code also explains how a company can establish “fair market value.” A third party may assist in developing an approach to assess fair market value, but in all instances, a company should incorporate objective and verifiable criteria. Companies are encouraged to document their methods to evaluate whether compensation reflects the fair market value of the services provided.
Consolidations: The AdvaMed Code consolidates the following sections:
- Industry conducted training, education, and other business meetings into a comprehensive section that provides parameters for all industry-conducted programs;
- Third-party education, charitable, and research programs into a comprehensive section regarding grants, donations, and commercial sponsorships; and
- Meals, travel, lodging and venue sections into a comprehensive section that encourages companies to avoid selecting a setting because of its entertainment or recreational facilities, as well as encouraging companies to develop meal policies and review benchmarking information.
The updated AdvaMed Code notes that it does not replace any state laws, regulations, or codes that contain stricter requirements. Certain states, including California, Connecticut, and Nevada, have made the code’s provisions mandatory. Alleged violations of the federal Anti-Kickback Statute may provide a basis for whistleblowers or the government to file cases alleging that AdvaMed Code noncompliance is evidence of improper conduct. To reduce compliance risks, medical technology companies and HCPs should consider whether the updates to the AdvaMed Code warrant changes to their policies, procedures and practices, and contracts regarding interactions with one another. The delayed effective date of the new Code is intended to provide time to conduct this review.
Medical companies and Health Care Providers are well-advised to seek legal counsel to conduct a review of the paperwork governing their interactions. The health law attorneys at Farrow-Gillespie Heath Witter LLP can assist in that review.
Author Scott Chase is a health law and corporate attorney at Farrow-Gillespie Heath Witter LLP. Mr. Chase has been named to the lists of Best Lawyers in America (U.S. News & World Report), Texas Super Lawyers (a Thomson Reuters service), and Best Lawyers in Dallas (D Magazine) in every year for more than a decade.