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Genetworx Laboratories, the Virginia laboratory that used the Good Samaritans of America recruiter as a sales representative, agreed to pay $1.4 million to resolve allegations of Medicare claims for tests without valid physician oversight. The government’s criminal complaint described recruitment in senior housing, under the name of a nonprofit offering help with federal benefits. It alleged that recruiters collected DNA first and paid healthcare providers to authorize tests for people they had never examined. For someone inside a laboratory, the important question is what stood behind the signature on the order.
The Justice Department’s December 2015 account of the criminal complaint alleged that The Good Samaritans of America gained access to low-income senior housing complexes by presenting itself as a trusted nonprofit that helped seniors navigate federal benefit programs. The organization was a front for genetic-testing presentations, according to the complaint. Advertisements for free ice cream helped bring residents into the room.
The complaint described a pitch built around fear. The recruiter suggested that residents who skipped the testing would be vulnerable to heart attacks, stroke, cancer and suicide. He also claimed the tests would allow personalized medicine. A meeting offered as help with benefits had become a sales presentation about serious illness.
According to the complaint, recruiters took DNA swabs in the community rooms where they gave the presentations. Sometimes they arranged a later visit to a resident’s apartment. In either setting, no healthcare provider participated in collecting the swab or determined that the testing was medically necessary or appropriate.
The alleged operation had already persuaded the resident and collected the specimen before a clinician supplied the authorization. The resident’s willingness to be tested was doing the work that a clinical decision should have done.
The criminal complaint alleged that the recruiter found healthcare providers through Craigslist advertisements and paid them to sign requisition forms. Those providers entered contracts with The Good Samaritans of America. The forms they received often already contained the patient’s personal information, Medicare information, medication list and diagnosis codes.
Providers received thousands of dollars a month for authorizing tests for patients they had never examined and whose care or treatment they had no part in. The paperwork contained clinical-looking detail. The complaint’s point was that the person signing it had no treating relationship behind that detail.
In laboratory work, the order and the supporting medical record have different jobs. Under Medicare’s ordering and documentation rules, the treating physician or qualified practitioner orders the test and retains the documentation establishing medical necessity.
The design of a requisition has long been part of laboratory fraud prevention. Model Plan Helps Laboratories Fight Fraud, published in Laboratory Medicine in 1997, described the federal model compliance plan’s recommendation that forms give physicians space to document the medical necessity of each ordered test with a diagnosis code. The article also described audits and policies for creating and retaining records.
The Good Samaritans allegations show why the form and the clinical decision need to be examined together. A diagnosis code was already on many of the requisitions, according to the complaint. The question was who had determined that the resident needed the test, and on what basis.
The criminal complaint alleged that the scheme caused Medicare to pay more than $1 million to two clinical laboratories. The recruiter obtained commissions of tens of thousands of dollars from those laboratories. The providers who supplied the authorizations received their own monthly payments.
That is the business behind the free ice cream. The alleged chain joined access to residents, their DNA and Medicare information, paid authorizations, laboratory claims and commissions returning to the recruiter. Taxpayers financed the tests, while the money returning from the laboratories rewarded the person bringing in the residents.
The Justice Department announced the Genetworx settlement on July 9, 2021. Its account of the settlement allegations covers July 2014 through September 2015, when the Virginia laboratory used the Good Samaritans recruiter as a sales representative.
The government alleged that the representative persuaded groups of residents in senior housing to undergo genetic testing despite Medicare’s requirement for proper orders from a treating physician. The government also alleged that Genetworx submitted claims for those tests without valid physician oversight. The civil allegation reached the laboratory that billed Medicare, beyond the person who persuaded residents to provide samples.
The same announcement reports that the recruiter had pleaded guilty in federal court to conspiracy to commit health care fraud.
For a laboratory employee, the connection is concrete: a sales representative’s source of patients can matter to the orders arriving with their specimens. Here, the government tied the senior-housing recruitment directly to tests the laboratory billed to Medicare.
The genetic testing scandal involves recruiting people for tests and obtaining authorizations without a treating clinician deciding that those tests are needed. In the Good Samaritans complaint, senior-housing presentations supplied the patients and paid providers supplied the signatures. Another criminal case shows the same separation between selling a test and deciding it belongs in a patient’s care.
Scott Global, an Orlando telemarketing call center, illustrates the parallel. In the Justice Department’s account of its owner’s criminal trial, the evidence showed that he paid bribes and kickbacks to telemedicine companies to obtain doctors’ orders. The doctors approved expensive cancer genetic testing even though they were not treating the beneficiaries for cancer or its symptoms, often without speaking with them.
The recruitment setting changed from a housing complex to a call center. The clinical gap remained recognizable: the person authorizing the test was outside the patient’s care. An insider who knows how orders reached the laboratory may see that gap before it becomes visible in a Medicare claim.
A laboratory fraud case can connect the outreach business to the order, the testing and the payment. The Good Samaritans allegations put the people producing the requisitions at the center of that connection.
Someone involved in the outreach may know what residents were promised and whether a clinician took part. Someone handling orders may know where the diagnosis codes and medication lists came from, who signed, and how the provider was paid. Billing and finance staff may see the claims and the compensation flowing back to the source of the specimens.
The laboratory’s own work supplies another connection. Its records of the specimen received, the test performed and the result reported sit between the requisition and the claim. We examine that chain with you, including the clinical support for the order and the payments attached to the referral. The point is to understand how a sales decision became a test billed to Medicare.
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.
If you know how a senior-housing presentation became a signed genetic-test order or a laboratory commission, speak to one of our Whistleblower Experts about those orders. We build the case with you, bring in laboratory fraud whistleblower lawyers who understand paid referrals and unsupported orders, and stay beside you through the pursuit of a recovery.