Clarifying the Role of OIG Advisory Opinions in Pleading False Claims Act and Anti-Kickback Statute Claims

Introduction

In U.S. ex rel. D.O. Stephen Sisselman v. Zocdoc, Inc., the Second Circuit considered whether a relator’s qui tam complaint under the False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) survived a Rule 12(b)(6) motion given the existence of detailed Office of Inspector General (“OIG”) Advisory Opinions. Relator Stephen Sisselman, D.O., alleged that Zocdoc’s per-booking “success fees” to providers constituted unlawful kickbacks and induced false claims. After the government declined to intervene, Zocdoc moved to dismiss the second amended complaint for failure to state a claim and denial of leave to amend. The Court of Appeals affirmed dismissal with prejudice, endorsing a stringent view of pleadings when a defendant’s practices have been reviewed—and approved—by the OIG.

Key Issues:

• Does reliance on detailed, favorable OIG Advisory Opinions defeat an FCA/AKS claim at the pleading stage?
• What pleading standard applies to FCA claims (Rule 9(b)) and how do Twombly/Iqbal plausibility requirements interact?
• Under what circumstances may a court refuse further leave to amend (futility doctrine)?

Summary of the Judgment

The Second Circuit, in a summary order, held:

1. On a de novo review of dismissal under Rule 12(b)(6), Sisselman’s complaint failed to plead facts plausibly showing that Zocdoc’s fee program violated the AKS or induced false claims under the FCA.
2. The complaint fell short of Rule 9(b)’s heightened fraud-pleading requirements: it did not specify actionable false statements, misrepresentations to the OIG, or a strong inference of scienter.
3. The detailed OIG Advisory Opinions (AO 19-04 and AO 23-04), incorporated by reference, directly addressed—and rejected—the relator’s characterization of Zocdoc’s fees as unlawful kickbacks.
4. Leave to amend was properly denied as futile because the relator had already filed three versions of his complaint and proposed no new factual allegations to fix the deficiencies.

Analysis

4.1 Precedents Cited

The Court anchored its reasoning in well-established Supreme Court and Second Circuit precedent:

• Ashcroft v. Iqbal, 556 U.S. 662 (2009) and Bell Atlantic v. Twombly, 550 U.S. 544 (2007): set forth the “plausibility” standard under Rule 8(a).
• Miller v. U.S. ex rel. Miller, 110 F.4th 533 (2d Cir. 2024): reaffirmed that FCA claims are subject to the heightened pleading standard of Rule 9(b).
• In re 305 E. 61st St. Grp. LLC, 130 F.4th 272 (2d Cir. 2025): clarified de novo review of dismissals under Rule 12(b)(6).
• Revitalizing Auto Comtys. Env’t Response Trust v. Nat’l Grid USA, 92 F.4th 415 (2d Cir. 2024): approved considering documents incorporated by reference in a complaint.
• Balintulo v. Ford Motor Co., 796 F.3d 160 (2d Cir. 2015); Krys v. Pigott, 749 F.3d 117 (2d Cir. 2014); and Horoshko v. Citibank, 373 F.3d 248 (2d Cir. 2004): guided the futility analysis for denying leave to amend.

4.2 Legal Reasoning

The court’s reasoning rests on two pillars:

1. Plausibility & Fraud Pleading: Under Iqbal and Twombly, a complaint must allege enough facts to “state a claim to relief that is plausible on its face.” FCA allegations are deemed fraudulent and must satisfy Rule 9(b), specifying the who, what, when, where, and why of the alleged misrepresentations. Sisselman’s complaint did not identify any misleading statements to the OIG, nor compare what was disclosed with what was withheld, nor articulate a strong inference of intent to defraud.
2. Advisory Opinion Incorporation: The complaint repeatedly referenced—and did not annex—two OIG Advisory Opinions (AO 19-04, AO 23-04). Those documents explained in detail that Zocdoc’s fee structure varied by specialty, geography, and fair-market-value factors; and they expressly concluded a low risk of AKS violation. Incorporating them by reference, the court treated those opinions as judicially noticeable. The relator could not circumvent their clear analysis by labeling the fees “referral” or “marketing” kickbacks.

4.3 Impact

This decision sends a strong message to relators and defense counsel alike:

• Comprehensive OIG Advisory Opinions can be dispositive at the pleading stage if they squarely address—and authorize—the challenged conduct.
• Plaintiffs must plead around favorable regulatory opinions by alleging specific misrepresentations or conduct inconsistent with them.
• Relators filing FCA/AKS complaints should ensure robust, non-conclusory scienter allegations and precise factual detail from the outset.
• District courts and defendants may increasingly invoke incorporation by reference to rely on regulatory guidance in motions to dismiss.

Complex Concepts Simplified

• False Claims Act (“FCA”): Federal law imposing liability on those who submit fraudulent claims for government payment.
• Anti-Kickback Statute (“AKS”): Prohibits offering or accepting remuneration to induce referrals of federally reimbursable services.
• Qui Tam Action: A lawsuit brought by a private relator on behalf of the government, allowing the relator to share in any recovery.
• OIG Advisory Opinion: A non-binding—but persuasive—written determination by HHS’s Office of Inspector General assessing whether proposed healthcare arrangements implicate the AKS.
• Rule 9(b) Heightened Pleading: Fraud claims must detail “who” said “what,” “when,” “where,” and “why” it was false.
• Futility Doctrine: Courts need not allow amendment if any new complaint would still fail to state a viable claim.

Conclusion

U.S. ex rel. Sisselman v. Zocdoc establishes that when a defendant secures detailed, favorable OIG Advisory Opinions, a relator cannot proceed past the pleading stage without concrete allegations of misrepresentation or concealment. It reinforces the strict application of Twombly/Iqbal plausibility and Rule 9(b) in FCA litigation and underscores that leave to amend is futile absent a proffer of new, substantive facts. Going forward, practitioners must craft FCA/AKS complaints with precision—especially where regulatory guidance already examines the challenged conduct.