FOR IMMEDIATE RELEASE
October 17, 2006
|
 |
|
ADVAMED COMMENDS OIG’S PROMPT RESPONSE ON REQUEST FOR COMPLIANCE GUIDANCE
|
WASHINGTON, D.C. – AdvaMed today commended HHS’ Office of the Inspector General (OIG) for its swift response to the Association’s recent request for guidance regarding certain physician investment interests in medical device manufacturers and distributors.
In furtherance of AdvaMed’s ethical and compliance leadership, AdvaMed’s September 6 letter to OIG’s Industry Guidance Branch noted that some physician investment arrangements raise important health policy and legal questions and sought OIG’s guidance concerning the agency’s legal analysis applicable to such arrangements.
Specifically, AdvaMed’s letter requested:
Confirmation that specified OIG fraud and abuse guidance applies to arrangements in which physicians both receive an equity ownership interest in a device company or distributor and generate a substantial portion of the entity’s revenues through ordering – or influencing orders for its devices;
Clarification regarding OIG’s analysis of arrangements where a substantial portion of the entity’s revenues are derived from business generated directly or indirectly by physician investors; and
Publication of additional factors deemed by OIG as applicable to physician investment in medical device manufacturing and distributor entities.
In its response, dated October 6, OIG expressed appreciation for AdvaMed’s letter and confirmed that current OIG guidance referenced in the correspondence “would be applicable to physician investments in medical device manufacturing and distribution entities (as well as group purchasing agents).” OIG also clarified that the amount of revenues generated by a physician investor, whether directly or indirectly, is “a relevant factor” when it comes to scrutinizing a joint venture under the anti-kickback statute.
“AdvaMed would like to thank OIG for providing this important guidance in such an expeditious manner,” said Stephen J. Ubl, President and CEO of AdvaMed. “I believe the OIG’s prompt attention and swift response to our request is indicative of the importance OIG places on this issue. Collaboration between physicians and industry is crucial for the continued advancement of innovative medical technologies, and AdvaMed is taking the lead to ensure this collaboration abides by the highest ethical standards.”
Visit AdvaMed’s Web site at /NR/rdonlyres/5ED83318-E1F1-4D34-91FB-F3C0AC55992A/19470/oig_response_10606.pdf to see the OIG’s response.
###
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.