Medicare LCDs as Binding Standards in Criminal Health-Care Fraud: Commentary on United States v. Siefert & Ehn

I. Introduction

The Sixth Circuit’s published opinion in United States v. William Lawrence Siefert, M.D. & Timothy Ehn, D.C., Nos. 24‑5384/5385 (6th Cir. Nov. 24, 2025), arises from a health‑care‑fraud prosecution at the intersection of the opioid epidemic and Medicare billing rules. The case concerns a Northern Kentucky pain clinic’s systematic overuse and overbilling of urine drug testing (UDT), and it addresses a broad range of issues: sufficiency of the evidence, Rule 404(b) propensity evidence, the role and legal force of Medicare Local Coverage Determinations (LCDs), material variance doctrine, conflict-of-interest waivers, prosecutorial misconduct (in light of Ruan v. United States), and sentencing loss calculations in fraud cases.

The opinion is especially notable for its treatment of LCDs. The court holds that when a provider contracts with Medicare, he or she is bound to comply with LCDs; the court explicitly rejects the defense view that only Medicare contractors are “bound” by LCDs. In doing so, it aligns with the Ninth Circuit’s civil decision in Agendia, Inc. v. Becerra and imports that understanding into a criminal fraud context. This has significant implications for how “medical necessity” and compliance duties are assessed in federal health‑care‑fraud prosecutions.

The court ultimately affirms all challenged convictions (Ehn’s health‑care‑fraud and conspiracy convictions; Siefert’s health‑care‑fraud conviction) and upholds both defendants’ sentences as procedurally reasonable.

II. Overview of the Case

A. Parties and Roles

• Dr. Timothy Ehn – A chiropractor who owned and operated the Northern Kentucky Center for Pain Relief (the “Clinic”). He ran the chiropractic side but largely controlled business and billing operations.
• Dr. William Siefert – A medical doctor hired by Ehn in 2014 to run the medical side and serve as medical director. As a physician with DEA authority, he could prescribe controlled substances and order UDT.
• United States (Appellee) – Prosecuted the case through DOJ, alleging a multi‑year scheme to defraud public and private insurers.

B. Factual Background in Brief

The Clinic operated a referral‑only pain practice, prescribing opioids and “helper medicines” and employing UDT to monitor compliance and detect misuse. Initially:

• Presumptive (qualitative) UDT was performed in‑house.
• Definitive (quantitative, multi‑analyte) UDT was sent to outside labs such as Southwest Labs.

Definitive UDT is far costlier—and reimbursed at far higher rates—than presumptive UDT, and Medicare requires documentation of medical necessity and individualized justification for the specific classes of drugs tested. LCDs issued by local Medicare contractors specify when and how definitive UDT will be reimbursed.

The government showed that:

• Ehn directed that both presumptive and definitive tests be ordered for virtually every patient at every visit (monthly), regardless of individualized need.
• Ehn and Siefert jointly devised a business plan to purchase and finance an in‑house definitive-testing machine, projecting revenue at the highest Medicare reimbursement tier, without corresponding clinical documentation or justification.
• The Clinic engaged in prior uncharged overbilling schemes (e.g., overpayments from Wellcare and specimen-validity overbilling) that were later settled; Ehn chose to “stay quiet” about obvious windfalls.
• The in‑house definitive machine was often improperly maintained, giving unreliable, sometimes patently false results, yet the Clinic continued to bill insurers for those tests.
• Ehn, who could not legally prescribe opioids or order UDT, nevertheless micromanaged testing and billing practices, pushing providers toward high‑frequency, high‑complexity definitive tests.
• When Siefert realized the extent of over‑testing and lack of risk stratification, he wrote a memo acknowledging the likely need to reimburse insurers; Ehn responded by ordering a retroactive “audit” designed to classify most patients as “high‑risk” to minimize repayment obligations.
• After Siefert’s departure, Ehn himself operated the machine (despite lacking proper expertise), creating backlogs, leading to samples being processed too late to be clinically useful—or never processed—yet still billed.

C. Procedural History

• Both defendants were indicted for:
  • Conspiracy to distribute controlled substances (21 U.S.C. § 846),
  • Substantive unlawful distribution (for Siefert, 11 counts under 21 U.S.C. § 841(a)(1)),
  • Health-care fraud (18 U.S.C. § 1347),
  • Conspiracy to commit health-care fraud (18 U.S.C. § 1349).
• After a jury trial:
  • Siefert was convicted of health-care fraud but acquitted on all drug-distribution and conspiracy counts.
  • Ehn was convicted of substantive health-care fraud and conspiracy to commit health-care fraud; he was acquitted on the drug counts.
• The district court denied Rule 29 motions for acquittal and Rule 33 motions for new trial.
• Guidelines calculations were reduced by the court (to offense level 24 for Siefert and 26 for Ehn), and substantial below‑Guidelines sentences were imposed:
  • 18 months’ imprisonment for Siefert (Guidelines range 51–63 months).
  • 30 months’ imprisonment for Ehn (Guidelines range 63–78 months).
• On appeal, Ehn challenged:
  • Sufficiency of the evidence (both health-care fraud and conspiracy),
  • Admission of prior-acts evidence under Rule 404(b),
  • Denial of a proposed LCD jury instruction,
  • Material variance between the indictment and proof at trial,
  • Validity of his conflict-of-interest waiver,
  • Loss and restitution calculations.
• Siefert challenged:
  • Prosecutorial misconduct in the government’s use of evidence of uncharged patient deaths,
  • The district court’s loss calculation.

III. Summary of the Sixth Circuit’s Opinion

The Sixth Circuit (Judge Davis writing, joined by Judges Gilman and Mathis) affirmed in all respects:

• Sufficiency of the Evidence: The court held that a rational juror could find beyond a reasonable doubt that:
  • Ehn devised and executed a scheme to defraud health-care benefit programs by billing for medically unnecessary and unreliable definitive UDT at the highest reimbursement levels.
  • Ehn knowingly joined a conspiracy with Siefert to implement that scheme, as evidenced by their joint business plan, profit-sharing arrangements, standardized blanket testing, and manipulation of risk stratification.
• Rule 404(b) Evidence: The court upheld admission of evidence of:
  • Kickbacks from Southwest Labs,
  • Overpayment and double-billing settlements with Wellcare and other insurers,
  Not as propensity evidence, but to show knowledge, intent, motive, and lack of mistake regarding fraudulent UDT billing.
• LCD Instruction: The court found that the district court properly rejected Ehn’s proposed limiting instruction on LCDs because it misstated the law—providers who contract with Medicare are bound by LCDs, not only contractors.
• Material Variance: No variance existed between the superseding indictment and the government’s trial proof; billing for tests on malfunctioning equipment and for untimely, clinically useless tests fell squarely within the charged scheme of billing for services “not performed or not medically necessary.”
• Conflict-of-Interest Waiver: Ehn knowingly, intelligently, and voluntarily waived any potential conflict arising from his counsel’s firm’s representation of Wellcare/Centene in related civil matters; thus no Sixth Amendment violation occurred.
• Prosecutorial Misconduct (Patient Death Evidence): The court held that the government’s introduction of evidence of seven uncharged patient overdose deaths (for which it could show Siefert’s knowledge as to only three) did not constitute misconduct and did not render the trial fundamentally unfair. The evidence was relevant to Siefert’s knowledge and intent for the drug counts under Ruan, and limiting instructions plus acquittal on the drug counts negated any showing of prejudice.
• Sentencing & Loss Calculations: The district court’s method—using the total amount insurers actually paid for definitive UDT and discounting that number by 20% to account for potentially legitimate tests—was a reasonable estimate of loss under U.S.S.G. § 2B1.1 and supported by the record, including defense expert testimony.

IV. Analysis

A. Precedents Cited and Their Influence on the Decision

1. Sufficiency of the Evidence Framework

The court applied well‑established sufficiency‑of‑the‑evidence principles:

• United States v. Sumlin, 956 F.3d 879 (6th Cir. 2020) and United States v. Maliszewski, 161 F.3d 992 (6th Cir. 1998) – The standard: whether any rational trier of fact could have found the elements of the offense beyond a reasonable doubt, viewing the evidence in the light most favorable to the government and drawing all inferences in its favor.
• United States v. Ray, 803 F.3d 244 (6th Cir. 2015) – Sufficiency challenges are reviewed de novo but against a heavily deferential factual backdrop.
• United States v. Betro, 115 F.4th 429 (6th Cir. 2024) and United States v. Anderson, 67 F.4th 755 (6th Cir. 2023) (per curiam) – In health-care fraud cases, fraudulent intent can be inferred from circumstantial evidence; direct proof of subjective intent is not required.
• United States v. Bertram, 900 F.3d 743 (6th Cir. 2018) – Highlighted that billing for services performed too late to be medically useful can support fraud findings, a point echoed in this case regarding stale UDT results.

These authorities allowed the panel to emphasize that:

• Ehn’s documented knowledge of billing requirements,
• His direction of blanket testing, despite LCDs barring such practices,
• His manipulation of risk stratification to limit repayments, and
• His tolerance of malfunctioning equipment and untimely testing,

collectively provided ample circumstantial evidence of intent to defraud, even in the absence of a “smoking gun” admission.

2. Conspiracy and the “Rule of Consistency”

For the conspiracy charge, the court drew on:

• United States v. Rogers, 769 F.3d 372 (6th Cir. 2014) and United States v. Hughes, 505 F.3d 578 (6th Cir. 2007) – Conspiracy may be proved by circumstantial evidence showing agreement and knowing participation in a common scheme.
• United States v. Crayton, 357 F.3d 560 (6th Cir. 2004), United States v. Powell, 469 U.S. 57 (1984), and Getsy v. Mitchell, 495 F.3d 295 (6th Cir. 2007) (en banc) – These cases reject the so‑called “rule of consistency,” which had once required that a sole remaining conspirator be acquitted if all other alleged co‑conspirators tried with him were acquitted.

Ehn argued that because the jury acquitted Siefert of conspiracy, he, as the only convicted conspirator, could not stand convicted. The court, citing Powell and Crayton, reiterated that inconsistent verdicts among co‑defendants do not justify reversal; a jury might acquit one defendant for any number of reasons (lenity, error, compromise) without negating the existence of an agreement. This reinforced that conspiracy liability is assessed defendant‑by‑defendant based on the evidence against each.

3. Rule 404(b) and Prior Overbilling / Kickback Evidence

The admission of Ehn’s prior conduct with Southwest Labs and Wellcare invoked:

• Fed. R. Evid. 404(b) – Prohibits using prior acts to show character propensity, but permits them to show motive, intent, knowledge, absence of mistake, etc.
• United States v. Fairley, 137 F.4th 503 (6th Cir. 2025) and United States v. Adams, 722 F.3d 788 (6th Cir. 2013) – Establish a three‑step, “modified” abuse‑of‑discretion review:
  1. Clear‑error review of whether the other acts occurred.
  2. De novo review of whether they were offered for a permissible purpose under 404(b)(2).
  3. Abuse‑of‑discretion review of Rule 403 balancing (probative value vs. unfair prejudice).
• United States v. Barnes, 822 F.3d 914 (6th Cir. 2016) – Prior acts are especially probative where they are substantially similar and reasonably close in time to the charged conduct.
• United States v. Bartholomew, 310 F.3d 912 (6th Cir. 2002) – Limiting instructions mitigate possible prejudice from 404(b) evidence.

The court found the prior overbilling/kickback arrangements substantially similar in nature and timeframe to the charged UDT scheme. They illustrated Ehn’s familiarity with exploiting UDT billing and his willingness to keep illegitimate profits, directly undermining his “good‑faith” or “inadvertent error” narrative and making them admissible to show intent and knowledge.

4. Local Coverage Determinations (LCDs)

On the LCD instruction, the court relied on:

• United States v. Volkman, 797 F.3d 377 (6th Cir. 2015) – Articulates appellate standards for reviewing jury‑instruction refusals.
• Agendia, Inc. v. Becerra, 4 F.4th 896 (9th Cir. 2021) – A civil case holding that LCDs are binding on contractors and, functionally, on claim adjudication, subject to override by ALJs or HHS rulemaking.

The Sixth Circuit extrapolated from Agendia and the Medicare contractual framework:

• By enrolling in Medicare, providers agree to comply with Medicare’s rules, including LCDs.
• LCDs govern coverage and reimbursement unless and until they are overturned in a specific claim’s appeal or through agency rulemaking.

This directly undermined Ehn’s proposed instruction that only the contractor issuing an LCD is “bound” by it. The court held that instruction was legally incorrect and confusing, failing the first prong of the Volkman test (correct statement of law).

5. Material Variance and Single vs. Multiple Conspiracies

The variance analysis relied on:

• United States v. Mize, 814 F.3d 401 (6th Cir. 2016); United States v. Davis, 970 F.3d 650 (6th Cir. 2020); United States v. Budd, 496 F.3d 517 (6th Cir. 2007) – A variance occurs only when trial evidence proves facts materially different from those charged, and reversal requires prejudice to substantial rights.
• United States v. Kuehne, 547 F.3d 667 (6th Cir. 2008) and United States v. Hynes, 467 F.3d 951 (6th Cir. 2006) – Prejudice exists if the variance undermines the defendant’s ability to defend, the fairness of trial, or the indictment’s double‑jeopardy value.
• United States v. Adams, 722 F.3d 788 (6th Cir. 2013) and United States v. Caver, 470 F.3d 220 (6th Cir. 2006) – In conspiracy cases, a variance is found if a single charged conspiracy is proved as multiple conspiracies and that difference prejudices the defendant.

The court found no such divergence. The indictment alleged a single continuous UDT scheme involving medically unnecessary or not‑performed services, high‑complexity billing, and blanket orders, from 2017–2021. Billing for tests done on a malfunctioning machine or processed too late to guide treatment was simply one set of “methods, manner, and means” of the same scheme, not a separate fraud.

6. Conflict of Interest and Waiver

The Sixth Circuit drew from:

• United States v. Osborne, 402 F.3d 626 (6th Cir. 2005) – Conflict waivers must be knowing, intelligent, and voluntary; courts should ensure defendants understand their right to conflict‑free counsel and the potential hazards of conflicted representation.
• Fed. R. Crim. P. 44(c) and its Advisory Committee Note – Judges should confirm that defendants discuss conflict issues with counsel (or independent counsel) before waiving.

Applying Osborne, the panel held that Ehn’s repeated oral affirmations in a conflict hearing, combined with a signed written waiver expressly acknowledging his rights and the conflict, satisfied constitutional standards. Any latent strategic disadvantage (e.g., limited cross‑examination of Wellcare witnesses) did not negate the waiver’s validity.

7. Prosecutorial Misconduct and Evidence of Patient Deaths

The patient‑death evidence was analyzed under:

• United States v. Carson, 560 F.3d 566 (6th Cir. 2009) and United States v. Gardiner, 463 F.3d 445 (6th Cir. 2006) – Two‑step misconduct test:
  1. Were the prosecutor’s actions improper?
  2. If so, were they “flagrant” enough to require reversal?
• Ruan v. United States, 597 U.S. 450 (2022) – To convict a medical practitioner under § 841(a), the government must prove the practitioner knowingly or intentionally prescribed controlled substances outside the usual course of professional practice and not for a legitimate medical purpose.
• United States v. Hofstetter, 2019 WL 6718489 (E.D. Tenn. Dec. 9, 2019) – Cited approvingly by the district court for the proposition that overdose deaths can be relevant circumstantial evidence of a prescriber’s knowledge or deliberate ignorance under Ruan.
• Samia v. United States, 599 U.S. 635 (2023) – Reinforces the presumption that juries follow limiting instructions.
• United States v. Haywood, 280 F.3d 715 (6th Cir. 2002) – Limiting instructions often cure prejudice from potentially inflammatory evidence.
• Slagle v. Bagley, 457 F.3d 501 (6th Cir. 2006) (quoting Darden v. Wainwright, 477 U.S. 168 (1986)) – Due process violation requires that the proceedings be so infected with unfairness that they amount to a denial of due process.
• United States v. Hernandez, 227 F.3d 686 (6th Cir. 2000) – Cumulative-error doctrine: even non‑reversible errors can add up to a fundamentally unfair trial.

The panel concluded that:

• Presenting death evidence to prove knowledge/intent under Ruan was proper; the district court’s pretrial order did not bar such evidence absent direct proof of knowledge of each death.
• The government had at least some circumstantial evidence of Siefert’s awareness of several deaths; the absence of direct proof for others did not demonstrate bad faith.
• Any potential prejudice was mitigated by careful limiting instructions, and the jury’s acquittal on all drug counts to which the death evidence pertained strongly undercut any claim that the evidence tainted the health‑care‑fraud verdict.

8. Sentencing Loss Calculation Under the Guidelines

Loss calculations were framed by:

• U.S.S.G. § 2B1.1 – The loss enhancement is based on the greater of actual or intended loss.
• United States v. Triana, 468 F.3d 308 (6th Cir. 2006) – Courts need only make a reasonable estimate of loss, particularly in complex financial frauds; precise calculation is not required.
• United States v. Wendlandt, 714 F.3d 388 (6th Cir. 2013) – Confirms that “actual loss” means reasonably foreseeable pecuniary harm.
• United States v. White, 492 F.3d 380 (6th Cir. 2007) – The district court must actually find facts supporting loss by a preponderance of the evidence.
• United States v. Rayyan, 885 F.3d 436 (6th Cir. 2018) – Sentencing procedural reasonableness is reviewed for abuse of discretion; underlying factual findings for clear error.

Using only the amounts actually paid by insurers for definitive UDT, and then reducing that figure by 20% to reflect potentially medically necessary tests, the district court followed an extrapolative, data‑driven approach the Sixth Circuit found well within the “reasonable estimate” standard, especially given testimony that legitimate definitive testing should account for only about 8–16% of the Clinic’s volume.

B. The Court’s Legal Reasoning

1. Health-Care Fraud and Conspiracy Elements

To sustain a conviction under 18 U.S.C. § 1347, the government had to prove that the defendant:

1. Knowingly devised a scheme to defraud a health‑care benefit program,
2. Executed (or attempted to execute) that scheme,
3. With the specific intent to defraud.

For conspiracy under 18 U.S.C. § 1349, the government had to show:

1. Two or more persons agreed to commit health‑care fraud, and
2. The defendant knowingly and voluntarily joined that agreement.

The court pointed to several core strands of evidence against Ehn:

• His role in crafting a business plan explicitly premised on billing at the highest definitive‑UDT reimbursement level for virtually all patients, without corresponding clinical need.
• His control over testing policies: “every patient, every visit” for both presumptive and definitive tests, contrary to LCD requirements that forbid blanket policies.
• His financial interest and profit‑sharing in UDT revenues.
• His awareness of prior overpayments from Wellcare and double billing for specimen validity testing, and his decision not to correct them until insurers intervened.
• His response to Siefert’s memo acknowledging over‑testing and the need for risk stratification: he ordered an “audit” designed to classify most patients as high‑risk, despite lacking medical authority, to minimize repayments.
• His knowledge of the definitive machine’s unreliability and his continuation of billing anyway, despite false positives and non‑clinically‑usable results.
• His billing for tests processed after samples were no longer reliable or never processed at all, rendering them not medically necessary yet still claimed.

Collectively, these facts supported a finding that Ehn did much more than rely on Siefert’s medical judgment. The court stressed that a rational juror could infer that:

• Ehn designed a billing‑centric business model around maximizing definitive UDT reimbursements.
• He took steps whenever issues arose (overpayments, guideline reminders, malfunctioning equipment) to protect revenue rather than ensure clinical necessity or billing accuracy.
• He and Siefert had a mutually beneficial arrangement: Siefert ordered tests under his DEA license; Ehn ran and monetized them.

This was enough to sustain both the substantive and conspiracy counts as to Ehn.

2. The Rejection of the Rule of Consistency

Ehn’s reliance on the defunct “rule of consistency” was squarely rejected. The opinion reaffirms that:

• Internal inconsistency in verdicts (e.g., one alleged co‑conspirator convicted, another acquitted) is legally tolerable.
• Juries may exercise lenity or reach compromise verdicts, but those choices do not undermine the legal sufficiency of the evidence against a particular defendant.

This reinforces existing case law and signals that defendants cannot defeat conspiracy convictions merely by pointing to co‑defendants’ acquittals at the same trial.

3. Rule 404(b): Knowledge, Intent, and Absence of Mistake

The court’s 404(b) analysis follows a classic pattern in white‑collar and health‑care‑fraud cases:

• The prior acts (kickbacks, overpayments) involved the same type of conduct—profiting from UDT billing and overpayments—during a timeframe adjacent to the charged scheme.
• They tended to:
  • Show Ehn’s awareness of the financial upside of aggressive UDT billing,
  • Undermine his claim that any over‑billing in the charged period was accidental or due to innocent misunderstanding,
  • Demonstrate a continuing pattern rather than isolated negligence.
• The trial court restricted the jury’s use of the evidence to permissible purposes: knowledge, intent, plan, motive, and lack of mistake.

By emphasizing both similarity and temporal proximity (Barnes) and the use of limiting instructions (Bartholomew), the panel signaled strong deference to trial judges’ evidentiary balancing in complex fraud cases where state of mind is central.

4. LCDs: Binding Standards and Incorrect Defense Instruction

Perhaps the opinion’s most forward‑looking element is its clear articulation that:

• When a provider agrees to participate in Medicare, he or she is contractually bound to follow Medicare laws, regulations, and program instructions, including LCDs.
• LCDs define when services (like definitive UDT) are “reasonable and necessary” for Medicare coverage and thus for reimbursement.
• LCDs are binding unless superseded by:
  • Administrative law judge decisions in specific claim appeals, or
  • Rulemaking by the Department of Health and Human Services.

Ehn’s proposed instruction minimized the force of LCDs by claiming that only contractors are “bound” by them and stressing potential appeals. The court highlighted two problems:

1. Legal inaccuracy: Providers are indeed bound by LCDs as a condition of participation; they cannot simply disregard them and later argue that only contractors are constrained.
2. Irrelevance and confusion: The appeal structure of LCDs does not bear on whether Ehn could be criminally liable for knowingly billing contrary to LCD requirements. The issue is not whether LCDs are infallible, but whether billing in knowing disregard of them evidences fraud.

By declaring the instruction incorrect at the threshold, the court did not need to reach the remaining prongs (whether it was substantially covered or critical to the defense). This cements LCDs as legitimate reference points in criminal fraud cases when evaluating “medical necessity” and compliance obligations.

5. No Material Variance Between Indictment and Proof

Ehn argued that the government charged him only with a scheme to bill for “medically unnecessary” tests, but tried a different theory at trial: billing for tests on faulty equipment and for useless delayed tests. The court rejected this split:

• The indictment explicitly alleged:
  • Bills for tests “not performed or not medically necessary,”
  • Use of a “blanket order” for both presumptive and definitive UDT,
  • Billing at higher complexity than necessary, and
  • Causing submission of bills for definitive UDT “not used to treat patients.”
• Evidence about broken machines and stale tests simply detailed why many tests were not medically necessary or not performed in a clinically meaningful way.

Under Kuehne, “the presentation of additional evidence to substantiate charged offenses” does not create a variance; it is the same scheme, simply fleshed out. Nor did Ehn show prejudice to trial preparation, fairness, or double‑jeopardy protection.

6. Conflict-of-Interest Waiver

The conflict question hinged on whether Ehn’s trial counsel’s firm’s representation of Wellcare and Centene in related civil matters created a disabling conflict that undermined his defense. The panel focused not on the underlying ethics issue, but on the validity of Ehn’s waiver:

• At a dedicated hearing, the court informed Ehn of:
  • His right to conflict‑free counsel,
  • The potential limitations posed by his counsel’s other representations (e.g., inability to use confidential information obtained from Wellcare against it or Centene),
  • His option to consult separate, independent counsel.
• Ehn explicitly:
  • Confirmed he had discussed the issue with counsel,
  • Declined independent counsel multiple times,
  • Signed a written waiver acknowledging the conflict and choosing to proceed.

Under Osborne, these steps sufficed to show a knowing, intelligent, voluntary waiver. The court therefore did not reach deeper questions about whether the conflict actually impaired counsel’s performance; the waiver foreclosed that line of attack.

7. Prosecutorial Misconduct and Patient Death Evidence Under Ruan

Siefert’s prosecutorial‑misconduct claim turned on whether the government misused death evidence contrary to the district court’s pretrial rulings and in bad faith. The panel carefully parsed the district court’s comments and conduct:

• The pretrial order did not categorically require direct proof that Siefert knew of each patient death; rather, it allowed death evidence as circumstantial proof of knowledge or deliberate ignorance.
• At trial, the government presented:
  • Evidence that Siefert knew about three patients’ overdose deaths,
  • Evidence of the other four deaths as “red flags” about his prescribing practices.
• When it became clear that the government lacked strong proof tying Siefert to knowledge of the other four deaths, the court:
  • Instructed the jury to consider death evidence only where Siefert knew or should have known of the deaths, and only for knowledge/intent regarding the drug counts,
  • Limited the government’s ability to reference the four less‑supported deaths in closing.

The key points in the panel’s reasoning:

• Evidence of patient overdose deaths is highly relevant post‑Ruan, as it bears on whether a prescriber knew or should have known that his prescribing was outside usual professional practice and not for legitimate medical purposes.
• Lack of direct proof for some deaths does not equate to lack of a good‑faith basis to introduce the evidence; the standard is not certainty but reasonable basis.
• Because the jury acquitted Siefert on all drug counts (the only counts to which death evidence was directly relevant), it is speculative to claim that the same evidence infected the separate health‑care‑fraud verdict.

Thus, the government’s conduct was not improper at step one of the Carson test, and no cumulative due‑process violation emerged.

8. Sentencing Loss Calculations: Methodology and Deference

Ehn and Siefert argued that the government failed to carry its burden to prove loss by a preponderance and that the 20% “legitimate test” discount was arbitrary. The court disagreed:

• The probation office initially calculated loss using the total amounts billed for definitive UDT and discounted by 20% for potentially legitimate tests.
• All parties agreed the correct baseline should be amounts actually paid by insurers, not merely billed.
• The district court adopted the “paid amount” baseline, then applied the same 20% discount, and further subtracted amounts the Clinic repaid to Wellcare under civil settlements.
• The 20% figure was anchored by:
  • Defense expert testimony that only about 8–16% of the Clinic’s definitive tests would reasonably be medically necessary under standard UDT guidelines.
  • The court’s choice to credit defendants with a more generous 20% legitimacy estimate.

Under Triana and White, this was a classic “reasonable estimate” of loss in a broad, pattern‑based fraud case. The court emphasized:

• Loss need not be established with mathematical precision.
• The methodology was explained on the record and rooted in trial evidence.
• Discounting only the highest‑reimbursement definitive tests, and not presumptive tests, already reflected a conservative approach favorable to defendants, because presumptive UDT may often be medically necessary.

Accordingly, no clear error occurred, and the sentences were procedurally sound—even though the court ultimately imposed below‑Guidelines sentences.

C. Impact on Future Cases and Health-Care Law

1. LCDs as a Foundation for Criminal Health-Care-Fraud Prosecutions

By affirming that participating providers are bound by LCDs and by treating LCD standards as integral to defining “medical necessity,” this opinion:

• Strengthens the government’s ability to use LCDs as objective benchmarks in criminal fraud prosecutions.
• Signals to providers that:
  • “Good faith” defenses premised on ignorance or disagreement with LCDs will face an uphill battle if the provider has contracted with Medicare.
  • Violating LCDs repeatedly and systematically, especially when doing so is financially lucrative, can readily support inferences of fraudulent intent.
• Aligns the Sixth Circuit with the Ninth Circuit’s understanding in Agendia, pushing toward a nationally coherent view that LCDs have real, enforceable legal force in both civil and criminal arenas.

2. Evidence of Prior Overbilling: 404(b) in Health-Care-Fraud Cases

The court’s approach to prior overpayment disputes and kickbacks demonstrates:

• Such evidence is likely admissible where:
  • It is similar in character to the charged conduct,
  • It occurred reasonably close in time, and
  • The defendant claims “accident,” “inadvertence,” or “good faith” in billing.
• Providers who have previously settled civil overpayment or kickback matters cannot assume those events are cordoned off from later criminal prosecutions; they may become powerful 404(b) evidence of knowledge and intent.

3. Ruan, Overdose Deaths, and Evidence of “Red Flags”

Post‑Ruan, prosecutors must prove that prescribers knowingly or intentionally acted outside the usual course of practice and without legitimate medical purpose. This decision:

• Affirms that evidence of patient overdose deaths—even uncharged and even when knowledge is partly circumstantial—can be used to show the prescriber’s awareness of misuse and the risks of ongoing prescribing patterns.
• Highlights the importance of careful, tailored limiting instructions to confine such evidence to the narrow purpose of proving mens rea on drug counts.
• Signals that courts will be reluctant to find misconduct where:
  • The prosecution has at least some basis to link the defendant to knowledge of deaths,
  • The trial court actively manages the use of the evidence, and
  • Acquittals on the relevant counts suggest the jury was not improperly swayed.

4. Loss Calculations in Health-Care Fraud

In the sentencing realm, Siefert & Ehn provides a blueprint for regulators and courts:

• Use aggregate claims data for the most suspect billing categories (here, high‑complexity definitive UDT),
• Limit the calculation to actual payments rather than billed amounts,
• Apply an empirically‑grounded, defense‑tested percentage discount to account for legitimate services, and
• Subtract amounts previously repaid in civil settlements.

Defendants will have difficulty challenging such methods where:

• They themselves put expert testimony before the court that supports (or understates) the assumed percentage of legitimate services, and
• The court adopts a figure more favorable than even the defense’s estimate.

5. Conflict-of-Interest Waivers and White-Collar Defense

The conflict analysis underscores:

• Defendants can knowingly waive even substantial potential conflicts involving counsel’s representation of counterparties (like insurers) in related civil matters.
• Trial judges that:
  • Conduct an on‑the‑record colloquy,
  • Explain the rights and risks, and
  • Obtain written waivers,
  will likely be upheld even when conflicts later appear strategically damaging.

For defense practitioners, the opinion is a reminder to:

• Fully document conflict discussions,
• Obtain explicit waivers, and
• Anticipate that later claims of “I didn’t understand” will generally fail if the record is clear.

V. Simplifying Key Legal Concepts

1. Health-Care Fraud (18 U.S.C. § 1347)

Health‑care fraud is essentially lying to get paid by health insurers. It occurs when someone:

• Intentionally creates a deceptive scheme,
• Sends false or misleading claims to Medicare, Medicaid, or private insurers, and
• Does so on purpose, to get money they are not entitled to.

In this case, the lies centered around:

• Billing for tests that were not medically necessary,
• Billing at higher complexity levels than justified,
• Billing for tests whose results were unreliable or not used in patient care.

2. Conspiracy to Commit Health-Care Fraud (18 U.S.C. § 1349)

Conspiracy is simply an agreement to commit a crime. For conspiracy to commit health‑care fraud:

• Two or more people agree to run a fraudulent scheme,
• Each knows what the scheme is and wants it to succeed.

There does not have to be a signed contract or a formal meeting; the agreement can be inferred from coordinated actions and shared profits.

3. Urine Drug Testing: Presumptive vs. Definitive

• Presumptive UDT: Quick, cheaper tests that say whether a drug is present (yes/no). These can be used routinely to monitor patients.
• Definitive UDT: More complex, lab‑based tests that measure how much of a drug (or many drugs) is in the system. They are more expensive and require justification for:
  • Why the test is needed at all, and
  • Why each class of drug tested is clinically relevant.

Medicare generally pays for presumptive tests if they are reasonably used. But it requires detailed justification for definitive tests, especially when ordered frequently or for many drug classes.

4. Local Coverage Determinations (LCDs)

LCDs are published policies by Medicare contractors that spell out when a service is covered. For example, an LCD on UDT might say:

• Presumptive tests may be used routinely in certain patients.
• Definitive tests must:
  • Follow an unexpected presumptive test result; or
  • Address specific clinical risks or circumstances.
• Blanket policies (e.g., ordering both tests for every patient every month) are not allowed.

By signing up to bill Medicare, providers agree to follow LCDs unless and until those LCDs are changed in appeals or by new rules.

5. Rule 404(b) Evidence

Rule 404(b) says courts cannot admit evidence of a person’s prior bad acts just to prove “he’s the kind of person who does bad things.” But such evidence can be used to show:

• What the person knew,
• What they intended,
• Whether something was really a mistake, or
• Whether there was a plan or pattern.

In this case, prior overbilling and kickbacks helped show that Ehn knew how to manipulate UDT billing and that repeated problems were not simple accidents.

6. Sentencing Loss Calculations

In fraud cases, the Guidelines increase sentences based on the dollar amount of loss. Courts typically:

1. Determine how much money victims actually lost (or how much the defendant tried to take),
2. Make a reasonable estimate where exact numbers are hard to calculate,
3. Use expert testimony and data (like billing records) to support their estimates.

Here, the court:

• Looked at how much insurers actually paid for definitive UDT,
• Discounted that by 20% to allow for legitimate tests, based on expert evidence,
• Subtracted amounts already repaid in civil settlements.

That figure then fed into the sentencing Guidelines range.

VI. Conclusion

United States v. Siefert & Ehn is a comprehensive health‑care‑fraud decision that does more than simply affirm convictions. It clarifies several important points of law and practice:

• LCDs are binding on participating Medicare providers and can serve as concrete benchmarks in assessing criminal liability for fraudulent billing.
• Prior overbilling and kickback disputes can be potent Rule 404(b) evidence of knowledge and intent in later prosecutions.
• Overdose deaths and other “red flags” remain valid circumstantial evidence of knowledge and intent under Ruan, so long as they are tied to mens rea and constrained by appropriate instructions.
• Conspiracy convictions stand or fall based on the evidence against the defendant, not on co‑defendants’ acquittals, cementing the demise of the “rule of consistency.”
• Conflict-of-interest waivers will be upheld where trial courts rigorously follow Rule 44(c) norms and defendants explicitly choose to proceed.
• Loss calculations in health‑care‑fraud cases may permissibly rely on aggregate data and reasonable percentage discounts grounded in expert testimony, without a claim‑by‑claim audit.

In the broader legal landscape, this opinion underscores that federal courts are prepared to treat program instructions like LCDs as substantive compliance standards, not mere billing “guidance.” Pain‑management providers and other high‑risk specialties should expect courts and prosecutors to measure “medical necessity” not just by individual clinical judgment but also by how closely practices align with articulated Medicare coverage policies.

For practitioners, Siefert & Ehn offers a roadmap for both sides: prosecutors on how to structure evidence of knowledge and loss, and defense counsel on the limits of certain arguments—particularly those minimizing the legal force of LCDs or repackaging systemic overbilling as benign error. It is likely to be cited frequently in future Sixth Circuit health‑care‑fraud prosecutions involving laboratory testing, opioids, and beyond.