Boston Scientific Corporation has announced in a press release that the company has entered into a civil settlement with the U.S. Department of Justice (DOJ). The settlement is in reference to the DOJ's investigation of certain post-market surveys Guidant Corporation conducted prior to Boston Scientific's 2006 acquisition of Guidant.

According to the press release, the settlement concludes the DOJ investigation that began in 2005. The settlement involves no admission of wrongdoing by Boston Scientific, and Boston Scientific has agreed to pay $22 million in previously fully accrued funds.

In addition to the funds being paid, by the agreement Boston Scientific will also enter into a Corporate Integrity Agreement (CIA) with the Office of Inspector General for the U.S. Department of Health and Human Services. This will involve enhancements to "certain compliance procedures related to financial arrangements with health care providers." According to the OIG's CIA, one of the procedures is for Guidant to post on its website by the end of June 2011 a prominent, easily accessible and readily searchable listing of all US.-based physicians and related entities or product decision-makers who or which received payments directly or indirectly from Guidant during the first three months of 2011. After that initial posting, 90 days after the end of each subsequent calendar quarter Guidant will post on the website a listing of updated information on payments provided during the preceding calendar quarter(s) in each calendar year.

Boston Scientific says the compliance is limited to its cardiac rhythm management business--part of Boston Scientific through the Guidant acquisition.

According to Boston Scientific's quarterly report filings with the Securities and Exchanges Commission, the company has also disclosed a subpoena served earlier in the year by the U.S. Department of Health and Human Services' Office of Inspector General that requested information on contributions from the Cardiac Rhythm Management group to charities with ties to physicians or their families. (See DM 11103).

Adapted in part from a press release by Boston Scientific.

The Boston Scientific press release: http://bostonscientific.mediaroom.com/index.php?s=43&item=885

The OIG CIA: http://oig.hhs.gov/fraud/cia/agreements/BostonScientificCIA.pdf

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