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Survey Series: Next steps for stakeholders to improve compliance

Device Regulation Alert: Safety, Compliance and Reimbursement News, April 16, 2007

A PricewaterhouseCoopers (PwC), King & Spaulding, and Compliance-Alliance survey of device companies found that most have implemented the AdvaMed Code of Ethics on Interactions with Health Care Professionals. Despite the high adoption rate, barriers remain, such as the need for clear regulatory guidance and lack of understanding from physicians and other customers about compliance rules.

The survey authors have identified several opportunities for stakeholders to improve industry compliance efforts, including the device industry itself, physician and professional societies, and regulatory and enforcement agencies.

According to Peter Claude, partner in Life Sciences and Advisory Services at PwC, the OIG has no plans to develop specific device compliance. Although the OIG advises device companies to follow its guidance for pharmaceutical manufacturers, Claude says there are enough differences between the two industries that a separate guidance is warranted. For example, pharmaceutical companies don't typically have to worry about physician ownership interests in a product, whereas that is a very common concern for device firms.

In addition to developing device industry guidance, government agencies can also help improve compliance by issuing additional guidance about specific compliance challenges, such as bundling arrangements, the survey authors say.

The authors also believe that enforcement should focus more on physicians who continue to solicit improper payments or support from manufacturers.

"For every grantor, there's a solicitor," Claude says of physicians who still expect these payments from companies.

In addition to greater enforcement against them, the survey also recommends greater education for physicians. Since physician pushback and solicitations are barriers to compliance, the survey recommends that physician professional societies educate their members about compliance with the AdvaMed Code. Claude tells tells Device Regulation Alert that companies can work with customer societies about what physicians cannot expect from manufacturers.

Finally, the survey authors place the onus on device manufacturers themselves to continue to implement robust compliance programs. It also recommends more widespread participation in the AdvaMed Logo program, which allows device manufacturers that adopt compliance policies consistent with the Code to license and display the AdvaMed Code Logo as a sign of a that they are commitmed to compliance issues.

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