Genetic Testing at Health Fairs: Buying the Patient and the Sample

Genetic testing health fair kickbacks buy access to a Medicare beneficiary and a DNA sample before a treating clinician has decided the test is needed. A recruiter offers a free swab, collects insurance information and sends the sample into a chain that produces an order and a laboratory claim. If you recruit patients, coordinate events or receive specimens at a laboratory, you may know how that chain starts. The paperwork that eventually reaches billing can tell a very different story from the conversation that produced the swab.

How Health-Fair Recruitment Feeds Genetic Testing Fraud

The genetic testing scandal involves billing Medicare for unnecessary tests or tests that the beneficiary’s treating physician did not order. The Department of Health and Human Services’ Office of Inspector General alert on genetic testing describes free screenings and cheek swabs used to obtain Medicare information for fraudulent billing or identity theft. Recruiters approached beneficiaries through public-event booths, health fairs, telephone calls and door-to-door visits.

When a genetic screening booth claims the test is free to a Medicare patient, the promise concerns what the patient pays. The laboratory can still submit a claim to Medicare. Covered clinical laboratory fee-schedule services generally carry no beneficiary deductible or coinsurance. The clinical decision about whether the patient needs the test remains essential to coverage.

We look at who promised coverage, who chose the test and who was paid when the sample arrived. An event coordinator may see the promise before anyone at the laboratory sees the order.

What Happens After the Health-Fair Swab?

The swab and Medicare information supply the front end of the transaction. A requisition supplies the next part. The laboratory then has a specimen to test and paperwork to support a claim. The fraud can lie in how the order was obtained and what the paperwork says about the patient.

The Department of Justice’s description of court documents in the criminal case involving Express Diagnostics and BioConfirm shows how this healthcare fraud scheme worked. The operators pleaded guilty. The court documents describe marketers who collected DNA and insurance information through health fairs, telemarketing and door-to-door solicitation. The marketers also obtained fraudulent requisitions from providers who had neither treated nor consulted with the beneficiaries and did not use the results in treatment.

Those court documents also describe falsified requisitions, letters of medical necessity and other medical records. Sham marketing contracts and invoices concealed the payments to obtain samples and orders. The paperwork gave a clinical explanation to a transaction driven by recruitment payments.

Across the laboratories in that scheme, approximately $522 million in false claims produced approximately $84 million in payments from Medicare, Medicaid and private insurers. A claim had traveled much farther than the cheek swab: through an ordering provider, medical-necessity paperwork, a laboratory and an insurer.

An accession employee who knows which company supplied the specimen, order and medical information can explain how the finished file came together.

Personalized Genomics and the Order Behind the Sample

The criminal information described in the Personalized Genomics announcement alleged a separate payment arrangement for acquiring samples and obtaining prescriptions. Marketers supplied cheek swabs to beneficiaries at purported health fairs or sent them to their homes. Their compensation depended on Medicare reimbursements for the samples they sent to the laboratories.

The charges also alleged payments to a telemedicine operator to obtain prescriptions. Contract physicians reviewed personal and family medical histories, but allegedly authorized testing without proper telemedicine visits and did not use the results to treat the beneficiaries. The swab and the prescription were separate purchases.

The tests’ purposes help explain the appeal. The criminal information describes cancer genomic testing as looking for mutations associated with future cancer risk. It describes pharmacogenetic testing as examining genetic variations that affect how a patient processes medications. These are promises about a person’s health that a recruiter can sell at an event. The missing connection in the allegations was the clinician using the test for that person’s care.

The information also alleged that the billing laboratories sent cancer samples to an outside reference laboratory while using their own locations to obtain higher Medicare reimbursement. For staff, the company on the claim, the company recruiting the patient and the laboratory performing the test could therefore be different businesses. Knowing the destination of a specimen can explain a part of the transaction that the beneficiary never sees.

Doctor Chase Starts After the Sales Decision

Doctor chase seeks an order from a beneficiary’s own physician after a marketer has already selected the beneficiary for testing. Reporting on the criminal trial of the owner of Axis Professional Labs and Kingdom Health Laboratory, the Department of Justice described nonmedical callers qualifying beneficiaries during telephone calls. Other companies then obtained the identities of those beneficiaries’ primary-care physicians and pressured them to approve genetic-testing orders.

That sequence puts the sales decision ahead of the clinical decision. The beneficiary has already been recruited when the physician enters the picture. An employee arranging the calls may know that the request began with a marketer, even if the finished requisition arrives bearing the patient’s own doctor’s name.

Sample payments, prescription payments and pressure on a treating physician leave different communications and payment records. We connect them to establish who chose the test and how the order reached the laboratory.

What the Laboratory Receives and What Medicare Requires

Medicare’s ordering and documentation rules tie diagnostic testing to a treating physician or qualified practitioner who uses the result to manage the beneficiary’s medical problem.

The clinician keeps the medical reason for the test. The lab keeps what the clinician sent and must show that its claim reflects that information accurately. A completed packet from a marketer raises the question of who supplied the clinical information inside it.

The laboratory also needs physician-supplied diagnostic information to support the diagnosis code on its Medicare claim. It can use a clinician’s narrative to select the appropriate code or ask the clinician for diagnostic information. It cannot invent a diagnosis to make the claim payable. The Inspector General’s clinical laboratory guidance specifically addresses making up claim information and software that inserts diagnosis codes without the ordering clinician’s information.

An accession or billing employee may see a family-history answer become a diagnosis, or an incomplete request return with a medical-necessity explanation. The questions we examine are who added the information, what the clinician actually supplied and whether the claim carried that information accurately. In a recruitment-driven scheme, the person completing the file matters as much as the person collecting the sample.

Who Gets Paid for the Sample and the Order?

The payment to the beneficiary and the payment for delivering a sample reward different participants. The criminal charges involving Ark Laboratory Network alleged that Ark partnered with Privy Health to obtain DNA samples and Medicare information, including through $75 gift cards, without a treating health care professional’s involvement. The alleged payment formula separately priced a hereditary-cancer DNA sample at $1,500.

The beneficiary’s incentive helped obtain the specimen. The sample payment rewarded the business delivering it. A recruiter may know about the first payment while a marketer’s invoice shows the second.

A doctor’s order could carry its own price. In a Texas doctor’s guilty-plea announcement, the Department of Justice described approximately $30 for each signed order authorizing equipment or cancer genetic testing. The doctor pleaded guilty to a scheme in which he prescribed without seeing, speaking to or treating the patients. The beneficiaries had been targeted through telemarketing and health fairs. The signature supplied another paid component of the claim.

The invoice’s label may hide what determines the payment. In its report on the Axis and Kingdom criminal trial, the Department of Justice described invoices that purported to charge for marketing hours but were worked backward from an agreed illegal payment per sample. In the Ark charges, the government likewise alleged sham hourly invoices for bribe amounts agreed in advance. The useful comparison is between what the invoice calls the work and what actually sets the amount paid.

The same disguise can appear as research. In its civil settlement with Primex Clinical Laboratories and DNA Stat, the government alleged that payments presented as compensation for clinical-study data actually paid physicians for patient referrals. The payment arrangement shows what the business was buying.

When the Screening Questions Are Written to Produce Referrals

A questionnaire can help sell a test by making the referral appear to follow from the patient’s answers. A whistleblower’s complaint concerning LabSolutions alleged that medical assistants working in physician practices used questions drafted by the companies arranging the referrals.

That allegation concerned work inside physician offices. It provides a useful comparison for someone familiar with an event’s screening script: who wrote the questions, and what were staff told to do with the answers? The complaint also alleged instructions to put false qualifying information on order forms for medically unnecessary tests. The words staff were trained to use, and the information they were told to enter afterward, connected the recruitment to the claim.

What Recruiters, Coordinators and Accession Staff Can Explain

The recruiter knows the offer and the incentive for the swab. A coordinator may know who supplied the screening questions or arranged the provider contact. Accession and billing staff can compare the specimen, order, clinical information and claim. Payment records connect that work to the business buying the referrals.

At senior housing events, staff may know who represented the testing as covered. Inside the laboratory, they may know that missing clinical information came back from a marketer rather than the ordering clinician. We connect those observations to the sample, order, claim and payments.

That is where an insider’s knowledge moves the inquiry beyond a suspicious booth. The finished paperwork shows what the laboratory presented for payment. The people who saw it assembled can explain who chose the words and why. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Saw How the Swab Became a Claim

If you know who recruited the beneficiaries, supplied the orders or paid for the specimens, speak with our whistleblower experts about the testing arrangement. We work with you to build a laboratory fraud case around those decisions and bring in genetic-testing fraud whistleblower lawyers who understand recruitment payments and medical-necessity claims. We stay beside you from that first conversation through the case.