“Particularity Means Particularity” – The Eleventh Circuit Narrows the Circumstances for Relaxing Rule 9(b) in False Claims Act Pleadings

Introduction

In Monica McKoy v. Atlanta Primary Care Peachtree, PC, No. 23-13845 (11th Cir. 2025), the Eleventh Circuit revisited the perennial clash between the heightened pleading requirement of Federal Rule of Civil Procedure 9(b) and the realities of whistle-blower litigation under the federal False Claims Act (“FCA”) and the Georgia False Medicaid Claims Act (“GFMCA”).

Relator-appellant Monica McKoy, a front-office receptionist at Newnan Family Medicine Associates (“NFMA”), alleged five fraudulent billing “schemes” against her former employer (NFMA), its owner Dr. Cecil Bennett, and a related practice (Atlanta Primary Care Peachtree, “APCP”). The District Court dismissed all claims under Rule 9(b) for lack of particularity. On appeal, the Eleventh Circuit:

Affirmed dismissal of four schemes (follow-up visits, use of incorrect provider identifiers, medical-assistant misconduct, and annual wellness visits).
Reversed in part as to the genetic-testing scheme, allowing only the kickback/self-referral component to proceed.

While limited in scope, the Court’s opinion is doctrinally significant: it sharply limits the “relaxed” Rule 9(b) approach some relators have enjoyed, clarifies what factual detail qualifies as “indicia of reliability,” and reinforces that Stark-Law and Anti-Kickback violations can suffice to plead falsity even absent allegations of medical necessity.

Summary of the Judgment

1. Rule 9(b) Standard. The panel held that the ordinary, stringent Rule 9(b) standard applies unless the relator’s job duties placed her in the billing chain or gave her first-hand knowledge comparable to that of billing personnel. Merely working at the front desk and having informal conversations does not suffice.

2. Disposition of Schemes.

Genetic testing – medical necessity theory: dismissed; McKoy failed to plead why representative tests were unnecessary.
Genetic testing – kickback/self-referral theory: survives; McKoy supplied dates, amounts, claim number, and Dr. Bennett’s ownership/kickback facts.
Follow-up visits, provider-identifier misuse, medical-assistant misconduct, annual wellness visits: dismissed for lack of details about actual claims (no dates, CPT codes, amounts, or claim numbers).

3. Result. Affirmed in part, reversed in part, and remanded for further proceedings confined to the surviving kickback/Stark component of the genetic-testing scheme.

Analysis

Precedents Cited

United States ex rel. Clausen v. Lab. Corp. of America, 290 F.3d 1301 (11th Cir. 2002).
The cornerstone precedent requiring FCA relators to plead the “who, what, where, when, and how” of actual false claims, not merely fraudulent schemes. The Court quoted Clausen extensively to reiterate that rule.
United States ex rel. Urquilla-Diaz v. Kaplan Univ., 780 F.3d 1039 (11th Cir. 2015).
Distinguished between “false presentment” and “false statement” causes, both governed by Rule 9(b).
United States ex rel. Walker v. R&F Props. of Lake County, 433 F.3d 1349 (11th Cir. 2005); United States ex rel. Atkins v. McInteer, 470 F.3d 1350 (11th Cir. 2006)
Earlier cases where the court accepted a relaxed pleading standard because the relators were directly involved in billing; the panel here distinguishes them.
United States ex rel. Matheny v. Medco Health Solutions, 671 F.3d 1217 (11th Cir. 2012)
Provides for some leniency when the relator had “personal knowledge or participation” in billing fraud—again limited by McKoy.
McNutt ex rel. United States v. Haleyville Medical Supplies, 423 F.3d 1256 (11th Cir. 2005)
Recognized that Anti-Kickback violations render associated claims “false” under the FCA—critical for the surviving claim.
Multiple statutory authorities: False Claims Act, 31 U.S.C. §3729; Anti-Kickback Statute, 42 U.S.C. §1320a-7b; Stark Law, 42 U.S.C. §1395nn.

Legal Reasoning

1. The “Relaxed” Rule 9(b) Myth

The Court drew a bright line: unless a whistle-blower’s duties situate her in the billing pipeline (e.g. coding specialist, nurse practitioner who self-submits claims, accounts-payable employee), she must plead representative, itemized claims. McKoy was a receptionist; her access to the billing process was incidental and anecdotal. Thus, Clausen governs in full.

2. Particularity Elements Re-affirmed

For each alleged scheme, the Court searched for five datapoints (“who/what/where/when/how”). Without:

patient identifier (initials acceptable),
date of service,
CPT/HCPCS or billing code,
amount billed, and
claim number or documentary exhibit,

the pleading fails—unless the relator fits the narrow billing-insider exception.

3. Medical Necessity v. Kickbacks

The opinion separates medical-necessity falsity (inherently clinical) from regulatory/financial falsity (kickbacks, Stark). McKoy’s medical-necessity theory faltered because she could not allege why any specific test was unnecessary. Yet her regulatory theory survived because:

She supplied a specific BPP claim (date, amount, claim number).
She alleged Dr. Bennett owned the laboratories.
She documented a July 23, 2019 $796.36 kickback and an August 23, 2019 phone call detailing the scheme.

That sufficed to plead that at least one claim was rendered “false.”

4. Materiality—Left for Another Day

The District Court had relied on the “materiality” prong (from the Supreme Court’s Escobar) to dismiss the provider-identifier theory; the panel found it unnecessary to address materiality because McKoy never pleaded a fraudulent claim with the wrong identifier. Implicitly, if no claim is pleaded, materiality is moot.

Impact of the Decision

Narrowing the Billing-Insider Exception. FCA relators in the Eleventh Circuit can no longer rely on tangential access or general familiarity with an office’s procedures to invoke a relaxed 9(b) standard. Practitioners must gather—or plead an ability to obtain in discovery—concrete billing data.
Sustaining Kickback-Based FCA Claims. Even a single representative claim tied to a kickback or Stark violation can save a complaint. Compliance officers should note that ownership interests and inducement payments remain high-risk areas.
Practical Drafting Guidance. The opinion functions as a drafting checklist: include at least one complete exemplar claim for each separate alleged scheme.
Split with Other Circuits? Some circuits (notably the First and D.C.) have taken more lenient approaches post-Escobar. McKoy cements the Eleventh Circuit’s stringent stance, potentially setting the stage for inter-circuit tension.

Complex Concepts Simplified

False Claims Act (FCA). A federal law that lets whistle-blowers sue on behalf of the United States to recover treble damages from those who defraud government programs.
Rule 9(b). A Federal Rule of Civil Procedure requiring fraud allegations to be stated with “particularity,” meaning detailed facts—not just broad accusations.
Anti-Kickback Statute (AKS). Criminal law prohibiting payments to induce referrals for items or services reimbursable by federal health programs.
Stark Law. Civil statute prohibiting physicians from referring Medicare patients for designated health services to an entity in which they have a financial interest.
“Materiality.” The principle that the falsehood must be relevant to the government’s payment decision. If the government would have paid anyway, the misstatement may not be “material.”
“Indicia of Reliability.” Concrete details (dates, amounts, claim numbers) that give the court confidence actual false claims were submitted.

Conclusion

McKoy reiterates a hard truth for FCA plaintiffs in the Eleventh Circuit: allegations of fraudulent schemes are worthless without allegations of fraudulent claims. The Court tightened the aperture through which whistle-blowers must pass, confining the relaxed Rule 9(b) doctrine to relators with direct billing knowledge. At the same time, it affirmed that Anti-Kickback and Stark violations remain potent grounds for FCA liability when coupled with a single well-pleaded claim. Going forward, counsel bringing FCA suits in the Eleventh Circuit must either:

Obtain specific billing records before filing, or
Plead facts showing the relator personally participated in, or directly observed, the claim-submission process.

Failing that, dismissal is all but certain. Yet for healthcare entities, the surviving portion of McKoy’s complaint is a reminder that ownership entanglements and small kickbacks—sometimes as little as $796—can ignite treble-damages litigation. Compliance vigilance remains paramount.