Genetic Testing Fraud Defense
Former DOJ Fraud Section Prosecutors. Nationwide Defense for Laboratory Owners, Physicians, Marketers, Telemedicine Operators, and Executives Facing Federal Genetic Testing Fraud Investigations and Charges.
Based in Washington, D.C., Armstrong & Bradylyons PLLC defends laboratory owners, physicians, nurse practitioners, marketers, telemedicine operators, patient recruiters, and executives in federal genetic testing fraud investigations and cases nationwide.
The firm’s healthcare fraud defense practice is built on nearly a decade of combined experience at the nation’s preeminent healthcare fraud 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 to federal healthcare programs. The firm uses that experience to defend individuals in genetic testing fraud cases at every stage: from the first grand jury subpoena, through federal indictment, and at trial.
Genetic testing fraud is one of the highest-profile enforcement targets of the Medicare Fraud Strike Force. The firm defends individuals in every federal district where DOJ and HHS-OIG bring genetic testing fraud cases.
Armstrong & Bradylyons PLLC defends every genetic testing fraud case from the start as if it will go to trial. That is not a slogan. It is the operating principle of the firm, grounded in 25 federal jury trials in complex fraud cases in federal courts across the country.
Trial experience drives results at every stage. Genetic testing fraud cases are built on claims data, referral chain analysis, and cooperating witness testimony. They involve CGx and PGx test orders, physician certifications, marketer compensation arrangements, and allegations that tests were medically unnecessary, that physician orders were generated through sham telemedicine consultations, or that patient referrals were driven by kickbacks. The firm builds the factual record from the first day of engagement: analyzing billing data, retaining clinical experts, identifying and preparing witnesses, and developing a case theory that can withstand the government’s scrutiny.
The firm’s attorneys know how federal prosecutors build healthcare fraud cases because they built them. Scott Armstrong served for nearly a decade at DOJ’s Fraud Section, where he served as lead trial counsel in 16 federal jury trials, including complex healthcare fraud cases involving Medicare, Medicaid, and Tricare. Drew Bradylyons served as Chief of EDVA’s Financial Crimes and Public Corruption Unit and, before that, supervised the Healthcare Fraud Unit’s Miami Strike Force at DOJ’s Fraud Section. That combined experience provides the firm with an unmatched understanding of how federal healthcare fraud cases are investigated, charged, and tried.
The firm relishes the opportunity to try cases. Its willingness to go to trial and its proven skills at trial provide significant leverage in negotiations with federal prosecutors at every stage of a genetic testing fraud case.
Genetic testing fraud is a top-tier DOJ enforcement priority. It has been since 2019. The government treats the genetic testing industry as structurally vulnerable to fraud and prosecutes accordingly.
In September 2019, DOJ launched Operation Double Helix. That coordinated enforcement action charged 35 defendants across five federal districts for schemes that billed Medicare more than $2.1 billion for cancer genetic testing (CGx) and pharmacogenetic testing (PGx). The operation targeted every link in the supply chain: patient recruiters, telemedicine companies, laboratory owners, and the physicians who signed orders.
The enforcement has not slowed. In the 2025 National Health Care Fraud Takedown, DOJ charged 49 defendants for telemedicine and genetic testing schemes involving $1.17 billion in fraudulent claims. DOJ explicitly stated it will continue to focus on fraudulent genetic testing claims. Through Q4 2025, DOJ and HHS-OIG continued to bring individual prosecutions against laboratory owners, telemarketing operators, and physicians in genetic testing cases.
The sentences are severe. A Louisiana laboratory owner received 10 years. An Atlanta laboratory owner was convicted in a $463 million scheme. A New York physician received seven years for signing orders for patients he never examined. These are not outlier cases. They are the product of a sustained, data-driven enforcement program that identifies laboratories through claims-data analytics and works backward through referral chains to charge every participant.
CMS suspended $5.7 billion in suspected fraudulent Medicare payments in 2025 by leveraging advanced analytics and cross-agency coordination. The government’s new Health Care Fraud Data Fusion Center combines data from DOJ, HHS-OIG, FBI, and CMS to detect anomalous billing in real time. Laboratories with utilization outliers are being identified faster than ever before.
The firm’s genetic testing fraud defense practice is built on healthcare fraud trial experience, deep knowledge of Medicare coverage criteria for genetic testing, and years of experience investigating and prosecuting complex healthcare fraud cases at DOJ’s Fraud Section. These tools are deployed at every phase of a case.
Challenging the Government’s Billing and Utilization Analysis
Federal genetic testing fraud cases begin with data. CMS and the Health Care Fraud Data Fusion Center use predictive analytics to identify laboratories whose billing volume, test mix, or reimbursement patterns deviate from statistical norms. The firm retains forensic billing analysts to challenge the government’s statistical methodologies, outlier designations, and summary exhibits. Billing volume alone does not prove fraud. The firm ensures that distinction is drawn clearly and forcefully.
Establishing Medical Necessity for CGx and PGx Testing
The government’s case often hinges on the claim that genetic tests were medically unnecessary. Medicare covers CGx testing under narrow conditions: the patient must have a personal or family history of cancer, and a physician must use the results in an active treatment plan. PGx testing is covered only for specific drug-gene interactions. The firm retains independent genetics experts and oncologists to evaluate whether testing met applicable clinical standards and CMS coverage determinations. The government’s medical necessity opinion must be tested at trial through cross-examination.
Analyzing Marketer Compensation and Referral Relationships
In genetic testing cases, the government alleges that payments to marketers and telemedicine companies were illegal kickbacks under the Anti-Kickback Statute. Percentage-based compensation tied to the volume or value of referrals is the government’s primary theory. The firm analyzes compensation structures against AKS safe harbor regulations and OIG advisory opinions. It evaluates fair market value analyses, written agreements, and whether compensation was fixed or tied to referral volume. Where arrangements fall within recognized safe harbors, the firm builds that defense aggressively.
Challenging the Government’s Proof of Knowledge and Intent
Federal healthcare fraud and Anti-Kickback Statute violations require proof of knowing and willful conduct. Good faith matters. The firm presents evidence of compliance programs, reliance on legal counsel, legitimate business purposes for compensation arrangements, and the clinical basis for testing decisions. Where the government relies on cooperating witness testimony to establish intent, the firm attacks the reliability, credibility, and motivations of those witnesses. The firm’s attorneys have extensive experience cross-examining cooperating witnesses in federal healthcare fraud trials.
Federal genetic testing fraud investigations target individuals at every link in the supply chain: from the laboratory owners who bill Medicare, to the physicians who sign orders, the telemedicine companies that facilitate consultations, the marketers who recruit patients, and the call center operators who generate leads. Armstrong & Bradylyons PLLC defends these individuals in federal investigations, after indictment, and at trial.
Defense of Laboratory Owners and Operators
Laboratory owners are the primary targets of federal genetic testing fraud cases. The government holds them responsible for the laboratory’s billing practices, referral relationships, and marketer compensation arrangements. Prosecutors pursue owners who allegedly directed the submission of claims for medically unnecessary tests, paid percentage-based kickbacks to marketers for patient samples, used aggressive telemarketing to generate orders, or concealed ownership to evade CMS scrutiny. The firm defends laboratory owners by challenging the government’s evidence of personal knowledge, direction, and intent.
Defense of Physicians and Nurse Practitioners
Ordering physicians and nurse practitioners face federal charges when the government alleges they signed orders for patients they did not treat, ordered tests without clinical justification, conducted sham telemedicine consultations, or received kickbacks for generating orders. In Operation Double Helix, nine physicians were among the original 35 defendants. The firm defends medical professionals by challenging the government’s characterization of legitimate clinical judgment and establishing the medical basis for testing decisions.
Defense of Telemedicine Operators and Executives
Telemedicine companies that facilitated physician orders for genetic testing are high-priority enforcement targets. The government alleges these companies provided a pipeline of signed orders without genuine physician-patient relationships. The firm defends telemedicine executives by challenging the government’s evidence of knowledge, intent, and personal involvement in the alleged scheme.
Defense of Marketers and Sales Representatives
Genetic testing marketers face serious criminal exposure. The government treats percentage-based compensation as strong evidence of Anti-Kickback Statute violations. Marketers who collected patient samples at health fairs, conducted telemarketing campaigns, or brokered samples to laboratories face healthcare fraud, kickback, and conspiracy charges. The firm defends marketers by analyzing compensation structures, demonstrating legitimate services rendered, and contesting the government’s legal theory.
Defense of Patient Recruiters and Call Center Operators
Individuals who collected specimens through telemarketing campaigns, health fairs, or community events face federal charges when the government alleges they induced Medicare beneficiaries to submit to unnecessary testing. The firm defends patient recruiters by contesting the government’s evidence of fraudulent intent and the nature of the representations made to patients.
Federal genetic testing fraud investigations follow a pattern. Understanding that pattern is the first step to defending against it. Scott Armstrong and Drew Bradylyons built these types of cases as senior prosecutors at DOJ’s Fraud Section. They know how federal investigators identify targets, develop evidence, and present cases to grand juries.
Claims Data Analytics and Outlier Identification
The investigation starts with data. HHS-OIG, CMS, and the FBI use claims data analytics and AI-driven tools to identify laboratories whose billing volume, test mix, or reimbursement patterns deviate from statistical norms. A laboratory that bills disproportionately high volumes of CGx or PGx testing relative to its patient population will be flagged. The Health Care Fraud Data Fusion Center deploys advanced analytics to detect these patterns in real time. The flags trigger referrals to the FBI and HHS-OIG for criminal investigation.
Referral Chain and Supply Chain Analysis
Federal investigators trace the path of every specimen. They identify who recruited the patient, who collected the sample, who signed the order, and who billed Medicare. In genetic testing cases, the supply chain is often long and fragmented: call centers generate leads, marketers collect cheek swabs at health fairs, telemedicine companies provide physician orders, and laboratories process and bill. Prosecutors map financial relationships between every participant and compare payments to referral volume. That fragmentation is exactly what prosecutors exploit.
Physician Order Scrutiny
The government examines every physician order for genetic testing. Prosecutors focus on whether the ordering physician had a genuine treatment relationship with the patient, whether the physician examined or even spoke with the patient, and whether the test results were used in the patient’s treatment plan. In Operation Double Helix and its successor prosecutions, telemedicine physicians signed thousands of orders for patients they never treated, examined, or contacted. Those orders were generated through telemarketing campaigns and sold to laboratories.
Medical Necessity Review
The government retains medical experts to evaluate whether testing met applicable clinical standards and CMS coverage criteria. Medicare covers CGx testing under narrow conditions: the patient must have a personal or family history of cancer, and a physician must use the results in an active treatment plan. PGx testing is covered only for specific drug-gene interactions. A laboratory that bills high volumes of CGx panels for patients with no cancer history is building the government’s case for it.
Kickback and Compensation Analysis
The government investigates financial relationships between laboratories, marketers, telemedicine companies, and patient recruiters. Investigators compare payments to marketers against referral volume. Percentage-based compensation tied to the volume or value of referrals is a textbook Anti-Kickback Statute violation. Prosecutors trace the flow of money through bank records, contracts, invoices, and payment platforms. They identify sham consulting agreements, inflated service fees, and compensation structures designed to disguise per-referral payments.
Cooperating Witness Testimony
Genetic testing fraud prosecutions almost always rely on cooperating witnesses. Marketers, patient recruiters, and telemedicine physicians who plead guilty and agree to testify for the government. These witnesses provide the narrative that connects data anomalies to individual intent. They describe how samples were collected, how orders were generated, how payments were structured, and who directed the operation. Cooperating witnesses are inherently unreliable. They have powerful incentives to minimize their own conduct and exaggerate the defendant’s involvement.
Search Warrants and Electronic Evidence
Federal agents routinely seek and execute search warrants for cell phones, laptops, and cloud-based accounts in genetic testing fraud investigations. These warrants target communications between laboratory owners, marketers, telemedicine operators, and physicians that reveal knowledge of fraudulent billing, directives to generate unnecessary orders, discussions about kickback payments, and efforts to conceal the true nature of compensation arrangements. Federal agents obtain cloud warrants under 18 U.S.C. § 2703 of the Stored Communications Act and serve them directly on Apple, Google, and other service providers.
Federal genetic testing fraud prosecutions draw on several criminal statutes. The government charges aggressively and stacks counts. Understanding the statutory framework is essential to mounting an effective defense.
Healthcare Fraud (18 U.S.C. § 1347)
The primary charging statute in genetic testing fraud cases. Healthcare fraud makes it a federal crime to knowingly and willfully execute or attempt to execute a scheme to defraud any healthcare benefit program. In genetic testing cases, this statute targets billing for medically unnecessary tests, billing for tests ordered without a genuine physician-patient relationship, and submitting claims generated through kickback-driven referral arrangements. The penalty is 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.
Wire Fraud (18 U.S.C. § 1343)
The government frequently charges wire fraud alongside or as an alternative to healthcare fraud. Wire fraud applies to any scheme to defraud that uses interstate wire communications, which includes the electronic submission of Medicare claims. Wire fraud carries a maximum penalty of 20 years of imprisonment per count.
Anti-Kickback Statute (42 U.S.C. § 1320a-7b)
The Anti-Kickback Statute is at the center of most federal genetic testing fraud prosecutions. It prohibits offering, paying, soliciting, or receiving anything of value to induce or reward the referral of patients for services covered by federal healthcare programs. In genetic testing cases, prosecutors target percentage-based payments to marketers and patient recruiters, kickbacks to physicians for signing orders, and payments to telemedicine companies for generating orders without genuine patient consultations. Violations carry up to 10 years of imprisonment per violation.
Money Laundering (18 U.S.C. §§ 1956, 1957)
Money laundering charges are common in large-scale genetic testing fraud prosecutions. The government charges money laundering when it alleges that defendants conducted financial transactions involving the proceeds of the fraud scheme with the intent to conceal or promote the underlying fraud. Money laundering carries up to 20 years of imprisonment per count.
False Claims Act (31 U.S.C. §§ 3729–3733)
The False Claims Act is the government’s primary civil enforcement tool. It imposes liability on any person who knowingly submits or causes the submission of false or fraudulent claims to the government. In 2025, HHS-OIG investigations led to nearly 500 False Claims Act cases between April and September alone. FCA penalties include treble damages and per-claim penalties. Many genetic testing investigations run parallel criminal and civil tracks. FCA cases may be brought by the government directly or by private whistleblowers through the Act’s qui tam provisions.
Federal Program Exclusion and Collateral Consequences
Beyond incarceration and fines, a conviction or settlement in a genetic testing fraud case triggers mandatory exclusion from Medicare, Medicaid, and all federal healthcare programs under the authority of HHS-OIG. For physicians and licensed professionals, exclusion effectively ends a career. State licensing boards may initiate independent disciplinary proceedings.
What Is Operation Double Helix?
Operation Double Helix is a coordinated DOJ enforcement initiative targeting genetic testing fraud. It was launched in September 2019, when DOJ charged 35 defendants across five federal districts for schemes that billed Medicare more than $2.1 billion for cancer genetic testing and pharmacogenetic testing.
The operation targeted the full supply chain: laboratories, telemedicine companies, physicians, patient recruiters, and marketers. It remains an active enforcement program. DOJ explicitly stated in the 2025 National Health Care Fraud Takedown that it will continue to focus on fraudulent genetic testing claims.
Scott Armstrong and Drew Bradylyons defend individuals in federal genetic testing fraud cases nationwide, including cases arising from Operation Double Helix enforcement actions.
What Federal Charges Do Laboratory Owners Face in Genetic Testing Cases?
Laboratory owners face multiple federal charges, often stacked in a single indictment. The most common charges are healthcare fraud (18 U.S.C. § 1347), Anti-Kickback Statute violations, wire fraud (18 U.S.C. § 1343), conspiracy, and money laundering.
Healthcare fraud carries up to 10 years per count. Wire fraud carries up to 20 years per count. Money laundering carries up to 20 years per count. Federal sentencing guidelines calculate offense levels based on loss amount. In genetic testing cases, the alleged loss figures are often in the tens or hundreds of millions of dollars. The resulting guidelines ranges are severe.
Beyond prison, laboratory owners face restitution, forfeiture, and mandatory exclusion from federal healthcare programs.
How Does the Government Prove That Genetic Testing Was Medically Unnecessary?
The government retains medical experts to review patient records and evaluate whether the testing met applicable clinical standards and CMS coverage criteria.
Medicare covers CGx testing under narrow conditions. The patient must have a personal or family history of cancer, and a physician must use the results in an active treatment plan. PGx testing is covered only for specific drug-gene interactions where the results will guide prescribing decisions.
Prosecutors build their case by showing that tests were ordered for patients with no relevant medical history, that results were never communicated to treating physicians, or that orders were signed by telemedicine physicians who had no treatment relationship with the patient. An experienced healthcare fraud defense attorney challenges these conclusions through independent expert review and clinical documentation.
Can a Physician Be Charged for Signing Genetic Testing Orders?
Yes. Physicians are regularly charged in genetic testing fraud cases. In Operation Double Helix, nine physicians were among the original 35 defendants. Since then, DOJ has continued to charge physicians who signed orders for patients they did not treat, examine, or contact.
In Q4 2025, a New York physician was sentenced to seven years for signing CGx and laboratory test orders for patients he never treated. The government proved he received kickback payments in exchange for generating orders.
The firm defends physicians against these charges by establishing the clinical basis for testing decisions, demonstrating genuine treatment relationships, and challenging the government’s evidence of kickback payments and fraudulent intent.
What Sentences Have Been Imposed in Genetic Testing Fraud Cases?
Sentences in genetic testing fraud cases are severe. A Louisiana laboratory owner who used aggressive telemarketing campaigns to generate CGx orders received 10 years. The owner of LabSolutions in Atlanta was convicted in a $463 million scheme. A New York physician who signed orders without examining patients received seven years.
The federal sentencing guidelines calculate offense levels based on the loss amount. In genetic testing cases, alleged loss figures often exceed $100 million. At those levels, the guidelines suggest sentences well above 10 years before any adjustments. Restitution orders can reach into the hundreds of millions of dollars.
An experienced federal defense attorney can challenge the government’s loss calculations, argue for downward departures, and present mitigating evidence at sentencing. But the most effective defense is prepared for trial.
What Is the Role of Marketers and Patient Recruiters in Genetic Testing Fraud Prosecutions?
Marketers and patient recruiters are frequently charged in genetic testing fraud cases. The government alleges they induced Medicare beneficiaries to submit to testing through telemarketing, health fairs, or direct outreach, then sold the samples and signed orders to laboratories for percentage-based compensation.
Prosecutors treat this compensation as illegal kickbacks under the Anti-Kickback Statute. Payment tied to the volume or value of referrals violates federal law regardless of how the arrangement is documented or labeled.
The firm defends marketers by analyzing whether their compensation structures fall within recognized safe harbors, demonstrating that legitimate services were rendered, and challenging the government’s evidence of intent to induce referrals.
How Do Whistleblower Complaints Trigger Genetic Testing Fraud Investigations?
Many genetic testing fraud investigations begin with a qui tam whistleblower complaint filed under the False Claims Act. A current or former employee, marketer, or business associate files a complaint under seal. The government investigates in secret while the complaint remains sealed. The target does not know it exists.
Whistleblowers in genetic testing cases are often former sales representatives, laboratory employees, or telemedicine physicians who participated in the scheme and decided to cooperate with the government. They receive a percentage of any recovery.
If you suspect a sealed qui tam complaint has been filed, retain experienced federal criminal defense counsel immediately. Early intervention is critical.
What Defenses Are Available in a Federal Genetic Testing Fraud Case?
The available defenses depend on the specific allegations. Common defenses include the following:
Medical necessity. Retaining independent genetics and oncology experts to demonstrate that the testing met applicable clinical standards and CMS coverage criteria.
Lack of intent. Presenting evidence of good faith, compliance programs, reliance on legal counsel, and legitimate business purposes for the conduct at issue.
Safe harbor compliance. Demonstrating that compensation arrangements complied with OIG safe harbor regulations.
Challenging the data. Contesting the government’s claims-data analysis, outlier designations, and loss calculations.
Cross-examining cooperators. Attacking the credibility of cooperating witnesses who have plea agreements and sentencing incentives to implicate others.
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.
Does the Government Also Pursue Civil False Claims Act Cases for Genetic Testing Fraud?
Yes. DOJ pursues both criminal prosecutions and civil False Claims Act cases against laboratories and individuals in genetic testing fraud matters. Civil FCA cases carry penalties of up to three times the amount of damages plus per-claim penalties.
Many investigations run parallel civil and criminal tracks. Statements and concessions made in a civil matter or audit response can be used to build a criminal case. In 2025, HHS-OIG investigations led to nearly 500 False Claims Act cases between April and September alone. Laboratories that face criminal exposure often face simultaneous civil liability.
Scott Armstrong and Drew Bradylyons have years of experience navigating parallel civil and criminal healthcare fraud cases at DOJ’s Fraud Section and as defense attorneys.
Does Armstrong & Bradylyons Handle Genetic Testing Fraud Cases Nationwide?
Yes. Armstrong & Bradylyons PLLC defends individuals in federal genetic testing fraud investigations and prosecutions nationwide. The firm can practice in every federal district court in the country.
Genetic testing fraud prosecutions originate from DOJ’s Health Care Fraud Unit and from U.S. Attorney’s Offices across the country. Operation Double Helix charged defendants in five federal districts simultaneously. The 2025 Takedown spanned 50 federal districts.
Scott Armstrong and Drew Bradylyons have tried healthcare fraud cases and handled investigations in federal courts throughout the country during their combined 25-year DOJ career. The firm is based in Washington, D.C. and represents clients in every jurisdiction where DOJ, CMS, and HHS-OIG investigate and prosecute genetic testing fraud cases.