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IG unapproved device probe

This article was originally published in The Gray Sheet

Executive Summary

HHS Inspector General further narrows its probe into billing for unapproved devices, dropping the off-label component of the investigation. In early June, the IG sent subpoenas to more than 100 hospitals seeking documentation related to billing for procedures done over the last 10 years with devices that had not been approved by FDA and approved devices used for off-label indications. The IG subsequently told hospitals that the probe would only focus on 10 types of cardiovascular devices produced by 23 manufacturers ("The Gray Sheet" June 27, p. 1). With the latest modification, hospitals will only be required to provide data on unapproved devices, not off-label indications. The IG also has extended the deadline for submitting documents to the end of August and has reduced the number of years that the subpoena covers



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