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27 September 2023

OIG Advisory Opinion Touches On Commonly-Raised Concepts For Mitigating Anti-Kickback Statute Risk

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Katten Muchin Rosenman LLP

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While the recent US Department of Health and Human Services Office of Inspector General (OIG) Advisory Opinion 23-05 primarily focuses on the Requestor's proposed arrangement being disfavored based on "Contractual Joint Venture" elements.
United States Food, Drugs, Healthcare, Life Sciences

While the recent US Department of Health and Human Services Office of Inspector General (OIG) Advisory Opinion 23-05 primarily focuses on the Requestor's proposed arrangement being disfavored based on "Contractual Joint Venture" elements, various statements in the Opinion reiterate the OIG's view on three concepts frequently raised by requestors trying to mitigate risk:

1. Excluding Federal healthcare program patients from the arrangement – The OIG notes (a) how difficult it is to completely achieve a "carve out" of Federal healthcare program patients; (b) that there can still be improper remuneration; and (c) its "longstanding and continuing concerns about arrangements under which parties carve out ... Federal health care program business from otherwise questionable financial arrangements."

2. Discounting the rate for professional services – While the OIG does not reference "fair market value", it clearly disfavors Practice A lowering the rate on services provided to Practice B, as such discounting can result in Practice B unduly profiting and serve as an inducement for improper patient referrals between the practices.

3. Other people are doing it – The OIG turned the Requestor's explanation about other entities forming similar arrangements into further rationale as to why the proposed arrangement is problematic under the Anti-Kickback Statute; it could create unfair competition and improper patient steering.

In sum, if your arrangement does not fit squarely within a safe harbor, be careful what other factors you rely upon to try to mitigate risk of violating the Anti-Kickback Statute.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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