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Volume XII, Number 185

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July 01, 2022

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HHS-OIG Changes Boilerplate in its Advisory Opinions, But It’s Still Unfair

I just noticed that in late 2011, the HHS-OIG modified some of the boilerplate in its advisory opinions.  The boilerplate is very objectionable, probably calls for a due process violation, and may well be disregarded by a court.

Since late 2011, HHS-OIG advisory opinions have contained the following sentence stating that advisory opinions may not be introduced in evidence to show that a person (other than the person requesting the advisory opinion) did not violate the Anti-Kickback Statute or Civil Monetary Penalties Law:

This advisory opinion may not be introduced into evidence by a person or entity other than [name redacted] to prove that the person or entity did not violate the provisions of sections 1128, 1128A, or 1128B of the Act or any other law.

Previously, the comparable boilerplate sentence stated:

This advisory opinion may not be introduced into evidence in any matter involving an entity or individual that is not a requestor of this opinion.

Ordinarily, parties do not get to announce that a document that they’ve written is not admissible in court.  There is no privilege that covers an advisory opinion, and certainly no privilege covering an advisory opinion posted on the OIG’s web site.  If an advisory opinion is admissible under the applicable rules of evidence, a judge may well disregard the OIG’s inadmissibility assertion.

To be sure, the OIG has clearly declared, in many settings and elsewhere in advisory opinion boilerplate, that an advisory opinion is prepared solely for its requestor and no one else many rely upon it.  That’s fine.  But, what if someone does rely upon an advisory opinion?  Indeed, this happens frequently.  There is not much caselaw under the Anti-Kickback Statute or CMP Law, and practicing lawyers cite advisory opinions all the time as a result.

The Anti-Kickback Statute is a felony statute with a high scienter requirement.  It only makes illegal “knowing[] and willful[]” conduct.  If a criminal defendant, or a defendant in a civil False Claims Act case, relied on an advisory opinion, they need to be given a fair chance to explain their actions.  And that may require admitting into evidence the advisory opinion on which they relied.  Keeping out the advisory opinion presents obvious due process issues.

If the government wants to argue that it was not reasonable to rely on an advisory opinion, where the OIG cautions against doing so, that’s fine.  But, to state that an advisory opinion is not admissible by a criminal or FCA defendant goes way too far.

© 2022 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume II, Number 176
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About this Author

Jesse Witten, Drinker Biddle Law Firm, Washington DC, Healthcare and Litigation Attorney
Partner

Jesse A. Witten defends health care providers, pharmaceutical manufactures and other clients in the health industry against fraud and abuse matters in government investigations and litigation, particularly False Claims Act matters. Jesse also assists clients in internal corporate investigations and self-disclosures to the government of regulatory violations and Medicare/Medicaid overpayment. He counsels clients on compliance with Anti-Kickback Statute and Stark Law and laws governing the sale and marketing of medical devices and pharmaceutical products...

(202) 230-5146
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