Does your compliance program meet the revised AdvaMed Code?June 22, 2019
Medical technology and pharmaceutical companies interact with health care professionals (HCPs) in various capacities from product conceptualization through commercialization. Manufacturers consult the AdvaMed Code to inform their decision making and to ensure policies are consistent with industry standards. Several states (e.g., California, Nevada, Connecticut) have enacted laws that require device manufacturers to comply with industry codes like the AdvaMed Code. Other states are even more restrictive than the Code, e.g., Vermont and Massachusetts.
The revised Code goes into effect in about 6 months. It is critical to familiarize yourself now with the changes to ensure that your company is prepared for its implementation on January 1, 2020. Not following the Code carries risk—because even though the Code is not law, adherence to it carries weight with regulators.
What changed? Beyond some enhancements to the readability of the Code and an improved look and feel, there are several substantive additions and revisions made to the Code. Below is a summary of new sections that were added to the Code, as well as some notable updates to existing rules. You can access the updated Code in its entirety here: Updated AdvaMed Code.
New Additions to the AdvaMed Code (effective Jan. 1, 2020):
Section V – Jointly Conducted Education and Marketing Programs
This new section applies to education and marketing events that are jointly by a Company and an HCP, a.k.a., “co-marketing” or “collaborative” marketing programs. The revised Code provides a number of principles that Companies should follow when conducting a joint event:
(1) legitimate company need;
(2) controls to ensure no unlawful inducement;
(3) content should be balanced between HCP and Company;
(4) equitable contributions by HCP and Company (e.g., split costs, activities); and
(5) the arrangement should be documented in a written agreement.
Section X – Communicating for the Safe & Effective Use of Medical Technology
This new section acknowledges the importance of HCP access to truthful and non-misleading information about medical technologies, including on- and off-label uses. The Code provides principles for communicating about off-label uses:
(1) information must only be provided by authorized personnel;
(2) communications must be truthful and non-misleading;
(3) off-label information should be identified as such; and
(4) companies should develop policies and controls based upon the Code, FDA guidance, and current enforcement trends.
Section XII – Demonstration, Evaluation, and Consigned Products
A section was added to the Code to address consigned products. Consignment arrangements should be documented in a written agreement. Companies are encouraged to develop policies and implement appropriate controls for such units.
Section XIII – Company Representatives Providing Technical Support in the Clinical Setting
The revised Code acknowledges the important role that Company representatives may have in the clinical setting to provide technical support on the safe and effective use of medical technology. The revised Code provides principles for companies to follow:
(1) support only at the request of and under supervision of HCP;
(2) role as technical support is transparent;
(3) cannot interfere with HCP’s medical decision-making;
(4) must comply with hospital/facility policies and requirements; and
(5) involvement cannot eliminate overhead or expenses.
Notable Updates to the AdvaMed Code (effective Jan. 1, 2020):
Section II – Consulting Arrangements with Health Care Professionals
The Code was revised to provide additional detail about what constitutes a legitimate need for a consulting arrangement with an HCP. Information was added about objective valuation methods that can be used to establish fair market value and potential HCP conflicts of interest.
Section IV – Educational & Research Grants, Charitable Donations, and Commercial Sponsorships
The Code was revised to consolidate third-party program types into one section. A checklist was added for Companies to consider when reviewing requests for third-party program support. The revised Code also includes new defined terms: satellite symposium, educational grant, third-party program, third-party program organizer, and commercial sponsorship.
Section VI – Travel & Lodging; Venue
The Code was revised to consolidate these topics into one section and provides additional guidance on when a Company may pay for a HCP’s travel and lodging. The revised Code also provides principles to follow when selecting a location for Company-conducted programs. Venue should be:
(2) easily-accessible for participants;
(3) not chosen because of entertainment/recreational facilities; and
(4) luxury/resort facilities should be avoided without appropriate justification.
Section VII – Providing Modest Meals and Refreshments to Health Care Professionals
The Code was revised to consolidate this topic into one section and provide clear principles for Companies to follow when occasionally providing an HCP with modest meals and refreshments. Companies are encouraged to develop policies and controls on this topic.
Do you need assistance determining the impact the revised Code has on your organization?
Now is the time to assess your Company’s readiness for compliance with the updated Code. You can do this by auditing your policies, procedures, and practices. We routinely audit companies for compliance with industry codes (AdvaMed, PhRMA, ACCME) as well as the Food, Drug and Cosmetic Act; Anti-Kickback Statute; False Claims Act; HIPAA; and transparency (Sunshine) and gift ban laws. Gardner Law also designs, implements, trains-on, and manages compliance programs for clients.