In a notification published last week, OIG began soliciting proposals and recommendations for modifying existing and developing new safe harbor provisions under the Federal Anti-Kickback Statute (AKS). Public comments must be delivered by February 26, 2018.
On December 27, 2017, OIG issued its annual notification soliciting recommendations for modifications to current AKS safe harbors, proposals for new safe harbors, and proposals for new OIG Special Fraud Alerts. OIG is required to make this annual solicitation under 42 U.S.C. § 1320a-7d(a)(1).
In making proposals, OIG recommends including detailed explanations of “justifications for, or empirical data supporting” recommendations for safe harbors. In reviewing proposals and modifications, OIG will consider whether the safe harbor may result in an increase or decrease of any of the following:
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Access to healthcare services;
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Quality of healthcare services;
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Patient freedom of choice among healthcare providers;
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Competition among healthcare providers;
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Cost to Federal healthcare programs;
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Potential overutilization of healthcare services;
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Ability of healthcare facilities to provide services in medically underserved areas or to medically underserved populations; and
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Existence (or nonexistence) of any potential financial health benefit to healthcare professionals or providers.
Additionally, OIG periodically issues Special Fraud Alerts to inform healthcare providers of certain payment and business practices OIG considers to potentially violate the AKS. In deciding whether to issue a Special Fraud Alert, OIG considers the following:
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Whether and to what extent the practices that would be identified in the Special Fraud Alert may result in an increase or decrease as specified above, and
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The volume and frequency of the conduct that would be identified in the Special Fraud Alert.
OIG relies on those involved in the healthcare industry to create and modify safe harbors that will permit beneficial and innocuous arrangements and to bring to light those practices worthy of Special Fraud Alerts.
The notification with instructions on how to submit proposals can be found here.
