Healthcare Fraud Defense & Anti-Kickback Statute Defense

Federal healthcare fraud investigations often run for months or years before charges are filed. These investigations are frequently covert. The government does not always announce that you are a target. But there are warning signs, and recognizing them early is critical.

Common indicators include receipt of a grand jury subpoena for records, a Civil Investigative Demand from the DOJ Civil Division, or a request for documents from HHS-OIG or a UPIC auditor. Federal agents may contact a provider’s employees, former employees, or business associates for interviews. CMS may impose prepayment review or revoke billing privileges as a precursor to a law-enforcement investigation.

Less obvious signs also matter. A former employee may have filed a qui tam whistleblower complaint under seal. Those cases are investigated in secret. A provider will not know about a sealed qui tam complaint until the government intervenes or the seal is lifted. A sudden departure by a key employee, unusual questions from a billing contractor, or an unexplained audit request can all suggest that a whistleblower has come forward.

If any of these indicators are present, retain experienced federal criminal defense counsel immediately. Scott Armstrong and Drew Bradylyons served as senior prosecutors in DOJ’s Fraud Section, have tried federal healthcare cases in courts around the country, and understand how federal investigators build healthcare fraud cases from the ground up.

The federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) prohibits the knowing and willful offer, payment, solicitation, or receipt of anything of value to induce or reward referrals for services covered by federal healthcare programs, including Medicare, Medicaid, and TRICARE.

The government must establish that the defendant offered, paid, solicited, or received remuneration; that the remuneration was intended to induce or reward referrals for services covered by a federal healthcare program; and that the defendant acted knowingly and willfully. Under the ACA amendment, the government does not need to prove actual knowledge of the statute or specific intent to violate it. It is sufficient that the defendant acted with knowledge that the conduct was wrongful.

The “one purpose” test further lowers the government’s burden. If even one purpose of the payment was to induce referrals, the statute is violated, even if there were other legitimate purposes.

AKS violations arise across the full spectrum of healthcare fraud enforcement. The firm defends kickback allegations in home health referral networks, laboratory marketing services agreements, sober home patient brokering schemes, DME order generation arrangements, infusion center referral relationships, and digital health platform enrollment incentives. The OIG Safe Harbor Regulations define limited exceptions, but the safe harbors are narrow, technically demanding, and require factual support for protection. Violations carry criminal penalties of up to 10 years’ imprisonment per violation, civil monetary penalties, and exclusion from federal healthcare programs.

Scott Armstrong and Drew Bradylyons defend executives and medical professionals nationwide in investigations and charged cases involving the Anti-Kickback Statute.

The penalties are severe. Under 18 U.S.C. § 1347, healthcare fraud carries up to 10 years of imprisonment per count. If the fraud results in serious bodily injury, the maximum increases to 20 years. If it results in death, a life sentence is possible.

Beyond incarceration, defendants face substantial fines, restitution orders, and forfeiture of assets. Federal law mandates exclusion from Medicare, Medicaid, and other federal healthcare programs upon conviction. For controlled substances distribution under 21 U.S.C. § 841, penalties reach 20 years per count, with a mandatory minimum of 20 years if death or serious bodily injury results.

For licensed professionals, the consequences extend further. Physicians, nurses, and pharmacists face loss of professional licenses. The FDA can disqualify clinical investigators from conducting future studies. A conviction can end a medical career permanently. These stakes demand a federal healthcare fraud attorney with trial experience.

Medicare fraud investigations are coordinated across multiple federal agencies. DOJ’s Fraud Section and local United States Attorney’s Offices lead prosecutions. HHS-OIG, the FBI, and specialized Medicare Fraud Strike Force teams conduct the underlying investigations. In 2025, DOJ launched the Health Care Fraud Data Fusion Center, which combines artificial intelligence and multi-agency data analytics to identify emerging fraud schemes proactively.

These investigations often begin with data analytics. The government uses sophisticated claims-data analysis to identify billing outliers and anomalies. From there, investigators conduct patient and employee interviews, issue grand jury subpoenas for medical records and billing data, execute search warrants, and recruit cooperating witnesses. Specific investigative techniques vary by sector. Home health investigations compare homebound certifications against evidence of patient activity. Laboratory investigations analyze unbundling patterns and marketing services agreements. Telemedicine investigations examine prescribing patterns and platform business models. Pharmacy investigations trace prescription volume against wholesaler purchase records.

A defense attorney who understands how prosecutors build these cases can challenge the government’s data analysis and witness testimony. Scott Armstrong and Drew Bradylyons defend medical professionals in this space based on years of federal trial and investigative experience at the Healthcare Fraud Unit involving over $2.8 billion in alleged false claims to federal healthcare programs.

Yes. A healthcare fraud investigation puts your medical license at risk before a conviction.

State medical boards may initiate independent proceedings based on the underlying conduct. Federal program exclusion by the OIG can prevent a provider from billing federal programs, effectively preventing a provider from practicing medicine. The DEA can issue an Immediate Suspension Order revoking a practitioner’s authority to prescribe controlled substances. The FDA can disqualify clinical investigators from conducting future studies. State medical boards pursue scope-of-practice violations independently.

These proceedings often run simultaneously with a criminal case. Experienced defense counsel ensures that a provider does not make statements or concessions in an administrative or civil matter that can be used to build a criminal case. Scott Armstrong and Drew Bradylyons defend medical professionals with an ever-present eye towards any potential parallel criminal investigation.

The firm defends individuals across the full spectrum of federal healthcare fraud cases and investigations. The firm maintains dedicated practice pages for each enforcement area: home health fraud, hospice fraud, nursing home and SNF fraud, wound care fraud, durable medical equipment fraud, injection and infusion therapy fraud, pharmacy and compounding fraud, laboratory fraud, genetic testing fraud, behavioral health fraud, sober home fraud, autism and ABA treatment fraud, controlled substances diversion, telemedicine fraud, digital health platform and AI healthcare fraud, peptide and GLP-1 fraud, ketamine clinic fraud, stem cell and regenerative medicine fraud, med spa and aesthetic medicine fraud, and clinical trial fraud and research misconduct.

The firm’s healthcare fraud defense practice is built on nearly a decade of combined DOJ experience at the nation’s preeminent healthcare enforcement unit: the Healthcare Fraud Unit of DOJ’s Fraud Section. Scott Armstrong, Drew Bradylyons, and Andrea Savdie tried 17 federal jury trials in healthcare fraud cases at DOJ’s Fraud Section involving over $2.8 billion in alleged false and fraudulent claims.

Civil healthcare fraud investigations focus on recovering money. These may involve False Claims Act (FCA) actions, Civil Investigative Demands, and penalties including treble damages and per-claim fines. FY 2025 FCA recoveries exceeded $6.8 billion, with over $5.7 billion tied to healthcare.

Criminal healthcare fraud investigations focus on proving intentional and willful fraud beyond a reasonable doubt. Criminal cases carry the possibility of imprisonment, criminal fines, and restitution.

The government frequently runs civil and criminal investigations in parallel. The same conduct can expose a provider to both civil liability and criminal prosecution at the same time. This is one of the most perilous dynamics in healthcare fraud enforcement. Civil FCA exposure is expanding into new areas, including AI-driven clinical documentation under a “reckless disregard” theory and cybersecurity misrepresentations by digital health platforms.

Experienced defense counsel ensures that a provider does not make statements or concessions in a civil matter that can be used to trigger or build a criminal case. Scott Armstrong and Drew Bradylyons have years of experience navigating parallel civil and criminal healthcare fraud cases, both at DOJ’s Fraud Section and as defense attorneys.

Yes. Federal prosecutors regularly pursue healthcare executives and business owners for fraud within their organizations. The executive does not need to have personally submitted false claims. If a provider causes another to submit a claim with knowledge that the claim is false or fraudulent, a criminal case against that provider may be viable.

The government relies on theories of conspiracy (18 U.S.C. § 371) and aiding and abetting (18 U.S.C. § 2) to charge healthcare executives beyond those who submit the underlying false claims. DOJ is extending these theories to new defendant populations. Digital health platform founders face charges for designing business models that override clinical judgment. Behavioral health facility owners face charges for directing billing schemes through patient recruiters. MSO operators and private equity investors face exposure when they direct operational decisions that drive fraudulent billing.

If you are a healthcare executive under investigation, you need a defense attorney who understands how the government builds cases against corporate healthcare executives. Scott Armstrong and Drew Bradylyons built these cases for years at DOJ’s Fraud Section and now use that experience to challenge the government’s approach.

The available defenses depend on the specific allegations. Common defenses in a complex healthcare fraud or anti-kickback violation case include the following:

Lack of intent to defraud. The government must prove willful and knowing fraud. This is an extremely high burden under the law. Billing errors and negligence are not crimes. In controlled substances cases, the Supreme Court’s decision in Ruan v. United States requires proof that the prescriber subjectively knew or intended that their conduct was unauthorized.

Medical necessity. Defendants can challenge the government’s claim that billed services were not medically necessary. Clinical documentation, expert testimony, and applicable CMS coverage determinations support this defense across sectors including wound care, hospice, injection and infusion therapy, and behavioral health.

Good faith reliance. Reliance on the advice of counsel or compliance programs can negate the element of intent.

Challenging data analysis. The government relies heavily on statistical methodologies. At trial, the government converts investigative data into summary exhibits that can be challenged on underlying assumptions, inputs, and conclusions.

Disputing referral relationships. In anti-kickback statute cases, experienced defense counsel attacks the government’s proof of remuneration for referrals to sever the causal link. The firm analyzes compensation arrangements against OIG safe harbors and applicable statutory exceptions.

Regulatory ambiguity. In emerging enforcement areas such as peptide and GLP-1 products, stem cell therapies, and ketamine clinic operations, evolving FDA guidance and unsettled regulatory frameworks support good-faith defenses.

Scott Armstrong and Drew Bradylyons leverage their significant federal trial experience as former prosecutors to anticipate the government’s trial strategy and develop an aggressive, evidence-based defense.

Telemedicine fraud and digital health platform fraud are among DOJ’s most active enforcement areas. The government targets both providers who bill for telehealth services and the platform operators, algorithm designers, and investors who build the systems through which care is delivered.

The government investigates telehealth fraud by analyzing billing patterns for providers who bill high volumes of telehealth services with minimal or no patient interaction. Investigators target sham telemedicine consultations used to generate orders for durable medical equipment, genetic testing, or controlled substance prescriptions. DOJ is also developing “digital kickback” theories targeting algorithms that steer clinical decisions. The Done Global conviction in November 2025 established the enforcement template for platform-level prosecution.

A defense attorney experienced in telemedicine and digital health fraud can challenge the government’s characterization of legitimate telehealth practices as fraudulent. This is particularly important where evolving CMS regulations created genuine ambiguity about permissible billing during the rapid expansion of telehealth.

Federal healthcare fraud investigations are multi-agency operations that can take years to complete. DOJ’s Fraud Section Healthcare Fraud Unit leads prosecutions at the national level, working alongside U.S. Attorney’s Offices, the FBI, HHS-OIG, IRS Criminal Investigation, and CMS Program Integrity.

Investigations typically begin in one of three ways: the Health Care Fraud Data Fusion Center or CMS data analytics flags a provider as a billing outlier; a current or former employee files a qui tam whistleblower complaint under the False Claims Act; or a patient, family member, or referral source reports information to the government. The May 2025 expansion of DOJ’s Corporate Whistleblower Awards Pilot Program to include healthcare fraud is increasing whistleblower activity across all sectors.

Once an investigation is open, federal agents build the case through grand jury subpoenas for billing records and clinical documentation, search warrants, patient and employee interviews, financial analysis of bank records and compensation arrangements, and electronic evidence including emails, text messages, and EHR metadata. For laboratory cases, agents trace marketing services agreements and referral patterns. For pharmacy cases, agents analyze wholesaler purchase records against prescription volume. For digital health platform cases, agents subpoena source code, algorithm design documents, and internal product communications. The government also recruits cooperating witnesses who provide testimony and help prosecutors reconstruct the scheme from the inside.

Scott Armstrong and Drew Bradylyons built these cases as senior prosecutors in DOJ’s Fraud Section using every one of these tools. They now use that experience to identify the government’s investigative strategy early and mount an effective defense before charges are filed.

Yes. Armstrong & Bradylyons PLLC defends individuals in federal healthcare fraud investigations and prosecutions nationwide. The firm can practice in every federal district court in the country.

DOJ’s Health Care Fraud Strike Force operates in the Southern District of Florida, the Eastern District of Michigan, the Southern District of Texas, the Central District of California, the Middle District of Florida, the Eastern District of New York, the Northern District of Illinois, the Northern District of Texas, the Southern District of Louisiana, the District of New Jersey, and the District of Massachusetts. Healthcare fraud prosecutions also originate from U.S. Attorney’s Offices in districts beyond the Strike Force footprint, including the Northern District of California, where the Done Global digital health platform prosecution resulted in convictions in November 2025.

Scott Armstrong and Drew Bradylyons have tried healthcare fraud cases and handled investigations in Strike Force districts and federal courts across the country. The firm is based in Washington, D.C. and represents clients in every jurisdiction where DOJ and its Strike Force bring healthcare fraud and Anti-Kickback Statute cases.