The Numbers

The 2026 Takedown did not match last year’s record numbers.  But, 455 defendants, including 90 doctors and other licensed medical professionals were charged.  The coordinated enforcement involved a “whole of government” approach which included:

• Actions by the Centers for Medicare and Medicaid Services (CMS) to suspend 1,079 providers and revoke billing privileges for 1,403 providers.
• 48 Civil Monetary Payment settlements amounting to over $73 million, over 1,400 provider exclusions, and 25 actions by the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) under the Civil Monetary Penalties Law seeking more than $10 billion in payments to the Medicare Trust Fund from payments that CMS caught and suspended before the funds were paid to the fraudulent providers.
• Civil charges against 13 defendants for $14.8 million in health care fraud schemes, as well as civil settlements with 31 defendants totaling $23 million.
• 928 administrative cases by the Drug Enforcement Administration (DEA) seeking the revocation of authority to handle and/or prescribe controlled substances since October 1, 2025.

Increased “Whole of Government” approach

The government has always used multiple agencies in its efforts to combat fraud.  But the DOJ has now stated they are using “cutting-edge use of data analytics to target the worst actors”, including employing advanced data analytics through its Data Fusion Center. The DOJ is now working to ensure coordination with asset seizure, civil remedies, administrative actions, and payment-policy changes.  As a result, a single health care fraud investigation may now include parallel criminal, civil, administrative, exclusion, payment-suspension, and licensing consequences.  Conaway & Strickler, PC routinely handles licensing and regulatory issues as well as fighting False Claims Act issues at the civil and criminal level.  

Creation of the National Fraud Enforcement Division (“NFED”) 

NFED may be the clearest sign of this whole of government approach.  According to the April, 2026 DOJ memorandum, the NFED’s mission is to “zealously investigate and prosecute” fraud involving taxpayer dollars.  The 2026 Takedown appears to be NFED’s first major public health care fraud press release.

TRENDS: Healthcare Fraud in Allografts

Allografts and skin grafts cases have risen significantly from an emerging issue to front-line enforcement target.

The allograft cases are important to note because they clearly show what a healthcare investigation looks like in 2026.  The DOJ uses their data driven investigatory prowess to detect high reimbursement, aggressive marketing, alleged kickbacks, vulnerable patients, questionable medical necessity, and patient harm. In the press release for 2026, the DOJ charged 11 defendants in schemes involving allografts, and the press release described Medicare payments for allografts rising sharply before CMS adjusted payment rates.  

DOJ’s theory here is like the cancer genetic cases.  Both the allograft and CGx cases show a high payment for the claim which is an area that created an opportunity for fraud, according to the DOJ.  The 2026 Takedown shows how data analysis has moved to the forefront of their investigations. They comb through all the claims, match it with financial tracing and draw conclusions from there.

Thoughts for Health Care Companies

The 2026 Takedown reinforces that health care fraud enforcement is here to stay. As discussed above, the government investigations are becoming more coordinated, targeted and more focused on the numbers. 

It is important therefore to respond accordingly and be sure all documentation necessary is on hand before any type of inquiry occurs.  

Conaway & Strickler, PC has a deep understanding of these kinds of cases.  Sometimes, prompt disclosure and cooperation is the route to take and sometimes combatting the allegations is the route to take. We continue to monitor enforcement actions to remain aware of all of the newest developments.  Contact us for more information or for assistance.

The Whistleblower on Trial: The History and Uncertain Future of Zafirov v. Florida Medical

For over a century, the False Claims Act (FCA) has been the federal government’s most potent weapon against fraud. At its core sits the qui tam provision—a mechanism allowing private citizens (called “relators”) to sue companies on behalf of the government and pocket a portion of the recovered funds.

But a case in Florida has put the entire multi-billion-dollar whistleblower framework on trial. The case is United States ex rel. Zafirov v. Florida Medical Associates, LLC. After lower-court rulings and tense appellate arguments in December 2025, the legal and healthcare worlds are anxiously awaiting to see how the Eleventh Circuit Court of Appeals will rule.

The History of this False Claims Act suit: How We Got Here

The story began when Dr. Clarissa Zafirov, a physician in Florida, alleged that her employer and other defendants engaged in systemic Medicare fraud by misrepresenting patient conditions to pad federal reimbursements. The U.S. government chose not to intervene, leaving Dr. Zafirov to spearhead the complex litigation herself.

The defendants, however, didn’t just fight the fraud allegations; they attacked the constitutional foundation of the lawsuit. In September 2024, U.S. District Judge Kathryn Kimball Mizelle dropped a bombshell by dismissing Zafirov’s suit. She didn’t rule on whether fraud occurred. Instead, she ruled that the False Claims Act’s qui tam provisions are unconstitutional.

The Article II Battleground

Judge Mizelle’s ruling hinged on the Appointments Clause of Article II of the U.S. Constitution.
Is a Whistleblower an "Officer of the United States"? ├── YES ──> Must be appointed by the President, Courts, or Dept. Head. (FCA Fails) └── NO ──> Private citizen pursuing a claim. (FCA Succeeds)

Judge Mizelle argued that because a relator wields significant executive power—conducting civil litigation in the name of the United States to vindicate public rights—they act as an “Officer of the United States.” Because Dr. Zafirov appointed herself to this role by simply filing a complaint, her status bypassed constitutional appointment protocols. “Zafirov has determined which defendants to sue, which theories to raise, which motions to file, and which evidence to obtain… Yet no one… appointed Zafirov to the office of relator. Instead… Zafirov appointed herself. This she may not do.”
— Judge Kathryn Kimball Mizelle

While decades of judicial precedent across the country had uniformly rejected this argument, Judge Mizelle’s ruling breathed real life into a legal theory previously sparked by Supreme Court Justice Clarence Thomas in a 2023 dissenting opinion (U.S. ex rel. Polansky), where Justices Kavanaugh and Barrett also expressed interest in reviewing the issue.

The Eleventh Circuit Showdown

The Department of Justice and Dr. Zafirov promptly appealed, leading to highly anticipated oral arguments before a three-judge panel of the Eleventh Circuit on December 12, 2025.

The panel – Circuit Judges Elizabeth L. Branch, Robert J. Luck, and Senior District Judge Federico A. Moreno—focused intensely on the concept of control.

The arguments were mainly over two competing perspectives:

1. The Government’s and Relator’s Defense
The DOJ shifted its strategy slightly at oral arguments, focusing heavily on the “continuing position” prong of officer status. They argued that an “officer” must occupy a permanent, continuous government seat (like the Secretary of State). A whistleblower is a temporary, self-interested private actor whose role dissolves when the case ends. Furthermore, they argued the government retains ultimate control because it can step in and dismiss or settle the case at any time.

2. The Defense and Amici Pushback
Attorneys for Florida Medical and supporting business groups argued that when the government declines to intervene (which occurs in roughly 80% of FCA cases), the relator is entirely “in the driver’s seat.” They exercise massive, unaccountable federal authority to issue subpoenas, freeze corporate assets, and force massive settlements without answering to the President.

Prediction: How Might the 11th Circuit Rule?

Predicting appellate outcomes is tricky, but the panel’s questioning in December 2025 offered some clues. The judges did not treat the constitutionality of the FCA as a settled matter. They repeatedly pressed the DOJ on why Justice Thomas’s strict separation-of-powers logic was wrong.

The court essentially faces three paths:

1) Reverse the Dismissal (Uphold the FCA)
The court aligns with decades of historical practice and other circuits (like the Sixth Circuit’s January 2026 ruling), finding that private bounty-hunters are not public “officers.” Therefore it would remain business as usual. Whistleblower cases proceed normally in Florida, Georgia, and Alabama.

2) Affirm the Dismissal (Strike down Qui Tam)
The panel adopts Judge Mizelle’s and Justice Thomas’s strict textualist view that prosecuting public fraud is an exclusively executive function that cannot be outsourced to unappointed citizens. This would create Immediate chaos. Hundreds of pending qui tam cases in the Southeast would face dismissal, crippling a primary source of federal fraud recovery.

3) The Middle Ground (Narrow Procedural Fix)
The court rules that qui tam actions are only unconstitutional if the government completely declines to intervene, or suggests a fix where the DOJ must sign off on major litigation steps. A logistical headache for the DOJ, which would be forced to actively micromanage cases it initially wanted no part of.

The Verdict on the Horizon

Given the conservative, textualist leanings of the Eleventh Circuit panel, an affirmance (ruling the qui tam provision unconstitutional) is a highly distinct possibility. The judges seemed genuinely troubled by the lack of day-to-day executive oversight in declined whistle-blower lawsuits.

However, regardless of whether the Eleventh Circuit upholds the law or strikes it down, Zafirov is on a fast track to the ultimate destination. Because a stark circuit split is opening up between courts upholding the False Claims Act and those questioning it, this case is highly likely to end up before the U.S. Supreme Court, where the future of American whistleblower law will be decided once and for all.

The DOJ’s Health Care Fraud Unit coordinated the investigation with the help of strike forces across the nation. Key aspects of the historical take down include the following:

• Enormous monetary scale: Again, the federal government alleges $14.6 billion in intended losses in total across the criminal cases. Law enforcement has already seized $245 million in cash, luxury vehicles, cryptocurrency, and assets from alleged fraudsters. The Centers for Medicare and Medicaid Services (CMS) also proactively prevented $4 billion in fraudulent payments, suspended billing privileges of 205 providers.
• Civil charges and settlements: In addition to criminal charges being levied, law enforcement has also sought civil penalties from other providers and medical professionals. This includes civil charges against 20 defendants for $14.2 million in alleged fraud, as well as civil settlements with 106 defendants totaling $34.3 million.
• Transnational criminal networks: A major component—Operation Gold Rush—alleges a global ring used foreign straw owners to submit $10.6 billion in false claims for durable medical equipment. Though CMS blocked all but ~$41 million in Medicare payouts, insurers received about $900  Individuals abroad and co-conspirators in the U.S. used encrypted messaging and assumed identities to facilitate the purchase of medical supply companies and subsequent fraud by exploiting the stolen identities of over one million Americans spanning all 50 states and using their confidential medical information to submit the fraudulent claims.
• Telemarketing/genetic testing schemes: One $703 million scheme involved deceptive telemarketing, AI-generated “consent” calls, and stolen Medicare IDs—all to bill labs and DME suppliers
• Wound-care fraud on vulnerable patients: Roughly $1.1 billion in fraudulent Medicare submissions for amniotic allografts were applied to terminally‑ill or hospice patients, without medical need or oversight
• Opioid prescription diversion: 74 defendants, including 44 medical professionals, are accused of diverting over 15 million pills (e.g., oxycodone, hydrocodone), feeding the illegal drug trade
• Genetic testing & telemedicine: At least 49 defendants were tied to over $1.17 billion in telemedicine/genetic testing fraud, a key enforcement focus of the Takedown.

These are just some of the schemes and methods alleged as health care fraud. Additional cases totaling approximately $1.84 billion involved medically unnecessary tests and treatments, kickbacks, and stolen controlled substances. DOJ’s Health Care Fraud Unit, along with FBI, HHS‑OIG, DEA, CMS, and state AGs, led this nationwide operation. The Government was able to leverage cloud computing, artificial intelligence, and advanced analytics to identify emerging health care fraud schemes. Specifically, a new Data Fusion Center used AI to spot suspicious billing patterns

Professionals in the medical industry could face disruptions based on these trends. Individuals could be criminally indicted despite a lack of financial gain for any peripheral involvement in these schemes. With over 205 providers with billing privileges already suspended or revoked, firms must evaluate billing practices and ensure compliance before audits or criminal actions escalate. Medical professionals and individuals in the industry should be proactive in address any potential problems. Assessing practices through comprehensive billing audits, tightening consent documentation and patient qualification protocols, and reviewing prescribing practices are key to ensuring compliance.

Given the unprecedented scope of this takedown, anyone involved in Medicare/Medicaid billing—especially in telemedicine, genetic testing, wound care, DME supply, opioid prescribing—should evaluate their practices now. Protecting your license, assets, and reputation hinges on early legal counsel, transparent operations, and robust documentation. Upon any contact from law enforcement, individuals should secure legal counsel immediately. The presumption of innocence matters, and charges are allegations—not convictions. Early intervention and strong representation can shift outcomes. Medical providers should document everything diligently. Medical necessity, patient consent, referrals, and codes must be in writing and defensible.

Even if charges carry potential fines or incarceration, negotiated resolutions mitigating those consequences are viable. At Conaway & Strickler, we are highly experienced in federal health care fraud cases. Contact us to discuss your situation confidentially—we’re here to protect your rights and your future.

• Wire fraud
• Mail fraud
• Bank fraud
• Tax fraud (tax evasion or false statements)
• Healthcare fraud/FCA
• Medicare/Medicaid fraud
• PPP loan or COVID relief fraud
• Securities fraud
• Mortgage fraud
• Immigration or visa fraud
• Government contract fraud
• Identity theft or benefits fraud
• Trafficking in Counterfeit Goods or Services
• Anti kickbacks
• AML

The FBI gives this list of frauds and the DOJ publishes some of their cases here.

Fraud investigations can begin in a number of ways. In many cases, they are triggered by:

• A whistleblower or former employee
• A suspicious activity report
• A suspicious activity report (SAR) from a bank or financial institution
• Data flagged by automated fraud detection software
• A referral from another federal agency (e.g., IRS, SBA, USPS, HHS)
• A civil audit or regulatory review that uncovers irregularities
• Investigative journalism or public tips
• Problems in real estate transactions.  (FINCEN’s new rule extends Anti-Money Laundering (AML) and Countering the Financing of Terrorism (CFT) obligations to investment advisers involved in these transactions)

Once red flags are detected, the matter is referred to a federal investigative agency. These can include:

• Federal Bureau of Investigation (FBI)
• Internal Revenue Service – Criminal Investigation (IRS-CI)
• Office of Inspector General (OIG)
• Postal Inspection Service (USPIS)
• Securities and Exchange Commission (SEC)
• Health and Human Services (HHS)
• Small Business Administration (SBA)

If you have been contacted by federal agents FOR ANY REASON, contact a federal criminal defense attorney immediately.  Do not speak period.  If you have received a grand jury subpoena, contact a federal criminal defense attorney immediately.  If you have received a target letter, contact a federal criminal defense attorney immediately.  If you are being audited by the IRS, SBA, HHS or another agency, contact a federal criminal defense attorney immediately. It never hurts in this  last instance to have sage advice before the investigation goes any further.

At Conaway & Strickler, PC, we are here to help. Contact us to discuss your options.

When the federal government is paying for items or services rendered to Medicare or Medicaid beneficiaries, federal fraud and abuse laws apply. Healthcare professionals influence what services patients receive and are responsible for the documentation of those services. That documentation is the basis for bills sent to insurers, and ultimately, the Government’s payment of a beneficiary’s medical claims.

If a physician knew or should have known that the submitted claim was false, the attempt to collect unearned money constitutes a violation. Federal fraud and abuse laws include the following:

• False Claims Act (31 U.S.C. §§ 3729-3733)
• Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b))
• Physician Self-Referral (Stark Law).
• Exclusion Statute (42 U.S.C. § 1320a-7).
• Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a).

These laws aim to prevent improper billing practices and financial incentives that could compromise patient care. These laws further grant powerful enforcement tools to federal agencies to penalize violations, ranging from civil fines to criminal charges.

The government can audit claims and investigate providers when there is a reason to suspect fraud. Unusual billing patterns or reports from others, including staff, competitors, and patients, may raise suspicion of fraud and abuse. If you’re a doctor who bills government healthcare programs, compliance with these rules and procedures is critical, as violations can lead to severe legal consequences.

One of the most critical aspects of government payer compliance is coding and billing insurers accurately for services rendered. Physicians may inadvertently engage in practices that violate federal billing regulations. Common billing violations include:

• Upcoding: Billing for more expensive services than those actually provided.
• Unbundling: Separately billing services that are typically bundled together.​
• Unnecessary Services: Providing services that are not medically necessary to increase reimbursement.​
• Kickbacks: Receiving or offering remuneration for patient referrals.
• Billing for services that an improperly supervised or unqualified employee performed.

In addition to maintaining compliance with billing regulations, these laws set forth requirements for maintaining accurate patient records, protecting patient privacy, and more.

Given the complexity and severity of potential penalties, healthcare professionals who find themselves under federal scrutiny for billing practices should seek the counsel of a federal criminal defense attorney as soon as possible. Physicians must be vigilant in adhering to federal billing regulations to avoid severe legal consequences. Understanding the legal framework and implementing proactive measures can safeguard against inadvertent violations and protect your practice’s integrity. Contact us to schedule a consultation.

Experienced federal criminal defense attorneys like those at Conaway & Strickler, PC may suggest early on about the possibility of entering into a “deferred prosecution agreement” which is essentially a contract with the Department of Justice. DPAs are frequently used in cases involving corporate fraud, bribery, and antitrust violations.  These pretrial agreements may involve an admission of wrongdoing, the payment of fines, and the implementation of compliance measures.  Charges may be dropped if the defendant complies with the requirements of the agreement.  Generally, the Assistant United States Attorney will file the criminal complaint and the DPA with the court, so it is of public record. This will be accompanied by a formal request to the court that any prosecution be delayed according to the terms of the DPA, allowing the defendant to fulfill its agreed-upon actions.  This is very similar to conditional discharge / pre trial diversion agreements found at the state level.

An example of a DPA would be one that was entered in to by the DOJ and Teva Pharmaceuticals USA, Inc in August 2023 in response to the company’s involvement in a price fixing conspiracy involving several pharmaceuticals.   As seen in this example, terms can include paying a fine, waiving certain rights, agreeing to a factual basis for the charges, and an agreement to cooperate and compliance monitoring and of course, agreeing to what will happen if there is a breach of the agreement.

The central benefit to entering in to a DPA is that the individual or business entity is not convicted of any crime. It offers an opportunity to have the federal criminal charges dismissed or dropped once the accused completes all the required conditions.

Here is an another example of a DPA entered in to with the NDGA and Avanir Pharmaceuticals.  This pharmaceutical manufacturer based in Aliso Viejo, California, was charged for paying kickbacks to a physician to induce prescriptions of its drug Nuedexta.   Of note in that case – the Northern District of Ohio indicted four individuals, including former Avanir employees and one of the top prescribers of Nuedexta in the country, who were involved in the kickback scheme.  So, the company itself entered in to a DPA but there was still fall out with respect to some individuals and receiving criminal indictments.

Early intervention is key in a successful resolution in health care criminal matters.  We have extensively blogged about health care fraud.   Contact us if you need an experienced federal criminal defense litigator.  Our firm has vast experience in white collar criminal investigations including False Claims Act and antitrust investigations.

The False Claims Act (FCA), also known as the “Lincoln Law,” is a federal law that imposes liability on individuals and companies who defraud governmental programs. This includes submitting false invoices, making false statements to get paid by the government, or avoiding payment of money owed to the government. The law was originally enacted during the Civil War to combat fraud by government contractors supplying the Union Army with substandard goods; however, the FCA was strengthened in 1986, when Congress increased incentives for whistleblowers to file lawsuits alleging false claims on behalf of the government.

Under the FCA, individuals or entities can be held liable for knowingly submitting false or fraudulent claims for payment to the government. The FCA allows private individuals, known as “whistleblowers” or “relators,” to file lawsuits on behalf of the government and share in any monetary recovery. These lawsuits are known as qui tam actions. If the government intervenes in the lawsuit and recovers funds, the whistleblower is typically entitled to receive a portion of the recovered amount, often ranging from 15% to 30%. In fiscal year 2023, whistleblowers filed 712 qui tam suits, and this past year the Justice Department reported settlements and judgments exceeding $2.3 billion in these and earlier-filed suits.

The False Claims Act has been instrumental in recovering billions of dollars for the government and deterring fraudulent conduct in government programs and contracts. It is one of the most powerful tools available for combating fraud against the government in the United States. Healthcare fraud has remained a leading source of FCA claims in recent years.

The Justice Department has litigated several significant cases involving the Medicare Advantage program. The Cigna Group settled for $172 million to resolve allegations that it knowingly submitted and failed to withdraw inaccurate and untruthful diagnosis codes for its Medicare Advantage Plan enrollees to increase its payments from Medicare. Martin’s Point agreed to pay more than $22 million following allegations that it violated the FCA by submitting inaccurate diagnosis codes for its Medicare Advantage Plan enrollees. Other cases related to Medicare Advantage matters continue to be litigated including actions against the UnitedHealth Group, Independent Health Corporation, Elevance Health (formerly Anthem), and Kaiser Permanente.

With all of this going on, the US Attorney’s office increased its prosecutions of individuals of white collar crimes in the year 2021. White collar charges like fraud, theft, corruption, bribery, environmental crime, tax fraud, health care fraud, procurement fraud, money laundering, PPP loan fraud, etc will continue to get more attention from the Department of Justice.

What does this mean? It means that investigations of any sort need to be taken seriously and that you should contact a lawyer immediately if any wrongdoing is alleged.

Conaway & Strickler, PC has a long history of handling fraud cases of all varieties and is well equipped at fighting the DOJ in their overzealous prosecutions. Please feel free to contact us so that we can help you avoid future headaches.

Physicians and practice groups that have either received a letter or a “knock and talk” from the government should not attempt to deal with the allegations of improper billing without legal help. We can help you show the government that the all costs billed to Medicare were for services provided and that no costs were inflated. We can also enter into negotiations to settle claims of violations of the False Claims Act with the Department of Health and Human Services and the Officer of the Inspector General.

The government has worked hard in recent years in combating health care fraud under the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by the Secretary of the Department of Health and Human Services in May 2009. And one of the most powerful tools in the government’s arsenal is the False Claims Act.

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