False Claims Act Liability for Misdiagnosis-Coded Medicare Claims for Noncovered Chelation Therapy (and No Jury Instruction on Treble Damages)

False Claims Act Liability for Misdiagnosis-Coded Medicare Claims for Noncovered Chelation Therapy (and No Jury Instruction on Treble Damages)

I. Introduction

Case: United States v. Charles Adams (11th Cir. Jan. 21, 2026) (Not for Publication).
Parties: The United States (Plaintiff–Appellee) vs. Dr. Charles C. Adams and his practice, Charles C. Adams, M.D., P.C. d/b/a Full Circle Medical Center (Defendants–Appellants).
Context: Medicare reimburses only items and services that are “reasonable and necessary” under 42 U.S.C. § 1395y(a)(1)(A), and CMS issued National Coverage Determinations (NCDs) deeming EDTA chelation therapy not covered for atherosclerosis and other non-FDA-approved uses.

Factual core: From 2008–2015, Adams provided EDTA chelation therapy to patients for heart conditions and atherosclerosis—uses he described as “experimental”—but billed Medicare as if the patients had heavy-metal or lead poisoning (e.g., “poisoning by heavy metal,” “toxic effect of lead”).

Key issues on appeal: (1) Whether the district court properly excluded Adams’s medical expert under Rule 702/Daubert; (2) whether the evidence was sufficient to support FCA liability (falsity, scienter, materiality, causation); (3) whether the evidence supported the jury’s damages figure for all 4,407 claims; and (4) whether Adams should have been allowed to discuss treble damages with the jury after the government argued he should “pay back” the money.

II. Summary of the Opinion

The Eleventh Circuit affirmed across the board. It held that the district court did not abuse its discretion in excluding Adams’s expert for unreliable methodology; that substantial evidence supported the jury’s finding that Adams knowingly submitted 4,407 materially false Medicare claims; that the jury had sufficient evidence to award $1,109,743 in actual damages (supporting the district court’s trebling under the FCA to $27,567,729); and that the district court did not abuse its discretion by preventing argument or instruction about treble damages, which is a matter for the court—not the jury.

III. Analysis

A. Precedents Cited

1. Standards of review framing the appellate posture

  • Knepfle v. J-Tech Corp., 48 F.4th 1282 (11th Cir. 2022): Cited for abuse-of-discretion review of evidentiary rulings (including expert exclusion). This heightened deference mattered because Adams needed to show more than disagreement—he needed to show an unreasonable evidentiary call.
  • United States v. Beaufils, 160 F.4th 1147 (11th Cir. 2025) (quoting Rasbury v. IRS (In re Rasbury), 24 F.3d 159 (11th Cir. 1994)): Provided the “range of choice”/“clear error of judgment” articulation of abuse of discretion. The panel used this to emphasize that the district court’s expert ruling was comfortably within permissible choices.
  • United States v. Kendrick, 682 F.3d 974 (11th Cir. 2012): Noted the harmless-error principle for evidentiary rulings—no reversal absent impact on substantial rights.
  • Skye v. Maersk Line Corp., 751 F.3d 1262 (11th Cir. 2014) and McGinnis v. Am. Home Mortg. Servicing, Inc., 817 F.3d 1241 (11th Cir. 2016): Provided the de novo standard for Rule 50(b) review and the requirement that a verdict stands unless no reasonable person could reach it, with inferences drawn for the non-movant.
  • Guevara v. Lafise Corp., 127 F.4th 824 (11th Cir. 2025) (quoting Chi. Trib. Co. v. Bridgestone/Firestone, Inc., 263 F.3d 1304 (11th Cir. 2001)): Stated when a district court abuses discretion on Rule 59 (wrong standard, improper procedure, clearly erroneous findings).
  • Williams v. City of Valdosta, 689 F.2d 964 (11th Cir. 1982): Reinforced that a new trial requires the verdict to be contrary to the “great” (not merely “greater”) weight of the evidence—used to reject Adams’s repeated misstatement of the standard.
  • United States v. Gaines, 690 F.2d 849 (11th Cir. 1982) and United States v. Morales, 978 F.2d 650 (11th Cir. 1992): Cited for abuse-of-discretion review of limits on closing argument and refusal of requested instructions, respectively—relevant to Adams’s treble-damages complaint.
  • Thomas v. Broward County Sheriff's Office, 71 F.4th 1305 (11th Cir. 2023): Used to validate the district court’s practice of addressing Rule 50(b) and Rule 59 motions using the same factual account while applying distinct legal standards.

2. Expert admissibility and the “reliability” gatekeeping function

  • Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) and United States v. Frazier, 387 F.3d 1244 (11th Cir. 2004) (en banc): Established the Rule 702 gatekeeping requirement that expert testimony rest on reliable principles and methods. The court treated this as the core reason Dr. Born was excluded.
  • Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997): Quoted for the rejection of “ipse dixit” expert opinions—conclusions connected to data only by the expert’s say-so. The panel used Joiner to underscore that Dr. Born’s citations did not support his asserted standard-of-care views.
  • Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010) and Carrizosa v. Chiquita Brands Int'l, Inc., 47 F.4th 1278 (11th Cir. 2022): Supported exclusion where an expert had the chance to explain methodology but did not. Here, Dr. Born’s “trust” in Adams’s intentions was treated as methodology-free advocacy, not expert analysis.

3. FCA elements: falsity, scienter, and materiality

  • United States ex rel. Bibby v. Mortg. Invs. Corp., 987 F.3d 1340 (11th Cir. 2021): Provided the Eleventh Circuit’s four-element FCA framework: falsity, scienter, materiality, and causation/payment.
  • Yates v. Pinellas Hematology & Oncology, P.A., 21 F.4th 1288 (11th Cir. 2021): Cited for what makes a claim “false,” including misrepresenting services or falsely certifying compliance with requirements.
  • United States ex rel. Schutte v. SuperValu Inc., 598 U.S. 739 (2023): Central to scienter. The panel invoked SuperValu to emphasize that knowledge can be shown by actual knowledge, deliberate ignorance, or reckless disregard, and that awareness of a “substantial and unjustifiable risk” suffices.
  • Universal Health Servs., Inc. v. United States, 579 U.S. 176 (2016): Anchored the materiality inquiry: whether the misrepresentation had a natural tendency to influence payment, including whether the government would have denied payment had it known the truth.

4. Proof of damages and sampling references (not decided broadly)

  • United States v. Hangar One, Inc., 563 F.2d 1155 (5th Cir. 1977): Cited for the proposition that FCA recovery can be established via circumstantial evidence.
  • United States v. Lahey Clinic Hospital, Inc., 399 F.3d 1 (1st Cir. 2005) and United States ex rel. Absher v. Momence Meadows Nursing Center, Inc., 764 F.3d 699 (7th Cir. 2014): Mentioned to note that other circuits recognize sampling/extrapolation as methods of proof, while the panel declined to “make a broad pronouncement” on when such proof is sufficient because the verdict was supported by Adams’s own admissions and other evidence.
  • Finnegan v. Comm'r, 926 F.3d 1261 (11th Cir. 2019): Quoted for the general rule against considering issues raised for the first time on appeal, in discussing Adams’s IV-cost argument and whether it was preserved/supported.

5. Treble damages: jury’s role vs. court’s role

  • Cook Cnty., Ill. v. United States ex rel. Chandler, 538 U.S. 119 (2003): The key authority that the jury returns actual damages; the court applies multipliers and sets penalties. The panel treated this as directly defeating Adams’s “open the door” theory.
  • Ermini v. Scott, 937 F.3d 1329 (11th Cir. 2019) (quoting Beul v. ASSE Int'l, Inc., 233 F.3d 441 (7th Cir. 2000)): Cited for the principle that judges have no general duty to inform the jury of the legal consequences of its verdict because doing so may distort factfinding.
  • Pollock & Riley, Inc. v. Pearl Brewing Co., 498 F.2d 1240 (5th Cir. 1974) and Lehrman v. Gulf Oil Corp., 500 F.2d 659 (5th Cir. 1974): Antitrust cases used by analogy to support withholding information about mandatory trebling, to avoid jurors discounting damages or liability to offset the multiplier’s perceived harshness.
  • Bonner v. City of Prichard, Ala., 661 F.2d 1206 (11th Cir. 1981) (en banc): Explained why former Fifth Circuit decisions like Pollock & Riley and Lehrman are binding in the Eleventh Circuit.

B. Legal Reasoning

1. Excluding the defense medical expert: reliability, not persuasiveness

The panel rejected Adams’s characterization that the district court excluded Dr. Born because it found him “unpersuasive.” Instead, it held the exclusion rested on Rule 702 reliability: Dr. Born purported to defend the medical necessity of chelation therapy for atherosclerosis/heart conditions, yet (i) he claimed no established standard of care existed without supporting that assertion, (ii) he conceded major medical organizations disagreed, (iii) his cited materials did not support his conclusions, and (iv) he effectively replaced methodology with “blind faith” in Adams (“if Dr. Adams thought it was appropriate, it was”). Under Daubert, Frazier, and Joiner, that is classic ipse dixit—insufficiently tethered to reliable principles.

2. FCA liability: falsity, scienter, and materiality were supported by concrete proof

Falsity: The jury could find falsity because Adams billed EDTA chelation as treatment for heavy-metal/lead poisoning while he admitted he “never treated anyone for heavy metal toxicity.” A medical toxicologist’s review of 67 claims supported that the claimed diagnoses were not present. The mismatch between actual purpose (atherosclerosis/heart conditions) and billed diagnoses reasonably established false claims under Yates.

Scienter: Applying SuperValu, the court held there was at least reckless disregard: Adams was recorded acknowledging Medicare “does not pay for chelation therapy,” and his internal auditor warned that the records did not support the therapy. Continuing to bill anyway supported knowledge of a “substantial and unjustifiable risk” of falsity.

Materiality: Under Universal Health Servs. and the statutory definition, the misrepresentations were capable of influencing payment because Medicare’s NCDs and CMS manuals made the therapy noncovered for atherosclerosis and similar non-FDA-approved uses. A fraud-identification contractor testified CMS would not have covered the claims had it known the truth. That is strong evidence of payment sensitivity to the concealed facts.

3. Damages: why the jury could treat all 4,407 claims as false

Adams argued the government did not prove every claim was false, implying impermissible extrapolation from a 67-claim review. The panel concluded broad extrapolation analysis was unnecessary because Adams’s own testimony—never treating heavy-metal toxicity/lead poisoning—and the supporting medical testimony allowed the jury to infer that the entire billing pattern was false. The court also rejected Adams’s attempt to carve out IV-administration costs where there was no trial evidence that IVs were used for other reimbursable purposes, and noted preservation concerns.

4. Treble damages: properly withheld from the jury

The panel treated trebling as a post-verdict judicial function under Cook Cnty., Ill. v. United States ex rel. Chandler. It also relied on the broader principle (from Ermini and the antitrust analogies in Pollock & Riley, Inc. v. Pearl Brewing Co. and Lehrman v. Gulf Oil Corp.) that telling jurors about mandatory trebling risks distorting factfinding—jurors may under-award or avoid liability to counteract the multiplier. Thus, refusing Adams’s requested explanation/instruction was not an abuse of discretion.

C. Impact

Although designated “NOT FOR PUBLICATION” (and thus typically nonprecedential), the decision is practically significant in several ways:

  • Medicare medical-necessity enforcement under the FCA: The opinion reinforces that billing codes/diagnoses cannot be used as a workaround to obtain reimbursement for services Medicare deems noncovered (here, EDTA chelation therapy for atherosclerosis and other non-FDA-approved uses under CMS NCDs).
  • Scienter after SuperValu: The court’s application of “substantial and unjustifiable risk” underscores that providers who are warned (by auditors, internal review, or prior admissions) can face FCA liability even if they later rationalize their billing.
  • Expert testimony in medically intensive FCA cases: Defense experts must do more than endorse a clinician’s judgment; they must articulate a testable, literature-grounded methodology. “Trust” is not a method.
  • Damages presentation strategy: The panel’s treatment of damages suggests that, where a uniform billing practice is contradicted by admissions and clinical reality, the government may not need to litigate each claim individually to sustain a full-claims verdict—though the court expressly avoided a broad holding about statistical sampling.
  • Treble damages kept from juries: The decision aligns FCA practice with antitrust trebling logic: juries find actual damages; courts apply statutory multipliers, limiting the risk of “jury nullification by discount.”

IV. Complex Concepts Simplified

  • False Claims Act (FCA): A federal law imposing liability for knowingly submitting false or fraudulent claims for payment to the government. Here, the “claims” were Medicare reimbursement submissions.
  • Falsity (in billing): A claim can be false if it misrepresents what was treated or why it was treated (e.g., billing for lead poisoning when the service was actually for atherosclerosis), or if it falsely certifies compliance with coverage rules.
  • Scienter: The required mental state—actual knowledge, deliberate ignorance, or reckless disregard. Under SuperValu, it can be enough that the defendant knowingly ran a substantial risk the claims were false and submitted them anyway.
  • Materiality: Whether the lie mattered to payment—i.e., it was capable of influencing whether Medicare would pay. If Medicare would deny payment knowing the truth, materiality is usually strong.
  • NCD/LCD: Medicare coverage rules. An NCD (National Coverage Determination) sets nationwide coverage/noncoverage for specific services. Here, NCDs stated EDTA chelation therapy is not covered for atherosclerosis and similar non-FDA-approved uses.
  • Off-label use: Using a drug for a purpose not on its FDA-approved label. Off-label use is not automatically improper in medicine, but Medicare coverage depends on whether the use is “medically accepted” under CMS rules; here, CMS’s NCDs and guidance made the billed uses noncovered/experimental.
  • Daubert / Rule 702: The framework requiring expert testimony to be reliable and methodologically grounded—not just an expert’s say-so.
  • Rule 50(b) vs. Rule 59: Rule 50(b) asks whether no reasonable jury could have found as it did (legal sufficiency). Rule 59 asks whether the verdict is against the great weight of the evidence (new trial discretion).
  • Treble damages: Statutory tripling of actual damages. Under the FCA, the jury finds actual damages; the court applies the multiplier after the verdict.

V. Conclusion

United States v. Charles Adams affirms a substantial FCA judgment where a provider billed Medicare using heavy-metal/lead-poisoning diagnoses to obtain reimbursement for noncovered, experimental EDTA chelation therapy aimed at atherosclerosis and related heart conditions. The Eleventh Circuit upheld (1) strict Daubert gatekeeping against methodology-free defense expert testimony, (2) a straightforward application of FCA falsity, scienter (as articulated in United States ex rel. Schutte v. SuperValu Inc.), and materiality (under Universal Health Servs., Inc. v. United States), (3) a damages verdict encompassing all claims based on admissions and consistent evidence, and (4) the principle that juries should not be informed of mandatory treble damages, which are for the court to apply under Cook Cnty., Ill. v. United States ex rel. Chandler. Even as an unpublished disposition, the opinion offers a clear blueprint for litigating Medicare medical-necessity fraud theories and for managing expert and damages issues in FCA trials.

Case Details

Year: 2026
Court: Court of Appeals for the Eleventh Circuit

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