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HomeCompliance Update → OIG's new safe harbors, civil monetary penalty exceptions set to take effect

OIG's new safe harbors, civil monetary penalty exceptions set to take effect Print E-mail
Written by Vitale Health Law   
Monday, 26 December 2016 00:00

On January 6, new safe harbors to the federal anti-kickback statute and amendments to the civil monetary penalty rules will take effect. The expansion of existing safe harbors, along with the addition of new ones, were issued by the Department of Health and Human Services Office of the Inspector General on Dec. 7, and are expected to impact providers, drug manufacturers and pharmacies. You can read them here.


The changes add new safe harbors designed to protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. That statute makes it a crime to knowingly and willfully offer, pay, solicit or receive remuneration to induce or reward business reimbursable under federal healthcare programs. Safe harbors, which are updated periodically, are designed to protect certain business arrangements from prosecution if specific elements of the safe harbor are satisfied.

OIG noted that because of the broad reach of the statute, concern was expressed that some "relatively innocuous commercial arrangements" were covered by the statute and therefore, potentially subject to criminal prosecution.

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