HHS' Office of the Inspector General has issued an advisory opinion (pdf) stating that a clinical lab company's plan to contract directly with physician groups to establish their own labs could violate the anti-kickback statute.
The clinical lab company (the name has been redacted) proposed the development of a management company that would lease out lab space, equipment and other necessities to physician groups.
Although the physician-run labs would not test specimens from federal healthcare beneficiaries, the OIG states that the separation between federally funded and private-payer referrals can lead to anti-kickback violations. The OIG also notes that physician groups may be inclined to send Medicare testing to this lab company in order to secure more lucrative arrangements for their self-run testing.
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