Firms Must Show Evidence that Compliance Programs Work

It is not enough for medical device companies to have a compliance program relating to physician payments and perks. It is up to each company to demonstrate evidence that the program actually works, a consultant told those at the Medical Device Manufacturers Association meeting on June 13.Michael D. Bell, managing member of R-Squared, a compliance consulting firm, said that members of Congress and state legislatures are extremely focused on transparency and disclosure in the healthcare industry right now.

June 16, 2008

1 Min Read
Firms Must Show Evidence that Compliance Programs Work

And government litigators have gotten more aggressive in targeting companies who have questionable relationships with doctors. There may be as many as 100 investigations in progress, in fact.When firms have been caught, they have been forced to take measures that ensure future arrangements do not violate anti-kickback laws, he added. They have been told to create databases of all arrangements, track remuneration closely, and track service and activity logs to ensure that doctors are actually doing the work they're being paid for. In addition, they must perform a needs assessment before entering into a consulting arrangement, to show evidence that the doctor will be performing services that will benefit the company.All device firms should have such systems in place, he said. Not only that, but "it should not be paper-based. Embed it in your processes."Compliance process management should consist of four steps, Bell concluded. First, the business need must be established. Second, a selection process with objective criteria aligning potential consultants' qualifications with the business need must be conducted. Sales and marketing should have no part in that process. Third, a fair and thorough contract must be drawn up, reflecting fair market value for services. Fourth, the arrangement must be managed for its entire life. This includes requiring and documenting deliverables, requiring time sheets, documenting how the consultant's work product is being used by the company, and showing evidence that the arrangement is still needed come renewal time.-- Erik Swain

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