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The genetic-screening sales reps turn out at health fairs, houses of religion, parks and elder enclaves, offering seniors a chance to learn if they or their loved ones are at risk of developing cancer. All they need, the reps say, is a free cheek swab.

Reuters reports that, U.S. federal investigators say, some of the sales representatives are part of a burgeoning industry that threatens to become what multiple government investigators call the next big frontier in healthcare fraud: genetic testing, which is reaping millions of dollars from unnecessary tests that target senior citizens.

Shimon Richmond, assistant inspector general for investigations with the Office of Inspector General for the Department of Health and Human Services, said his office has seen a steady stream of complaints into genetic testing. In 2018, the inspector general’s office received about one or two complaints per week. Now, he said, the fraud hotline burns with as many as 50 calls weekly.

“We have investigations going on in this space across the country. It is not limited to one geographic region,” Richmond said in an interview. “This is touching every corner.”

In all, more than 300 federal investigations, conducted by multiple law enforcement agencies, are examining genetic testing fraud schemes, said a law enforcement official who spoke on condition of anonymity because the inquiries are not yet public. The investigative crush was sparked in part by unusual Medicare billing data patterns that started to emerge in 2015.

In the United States, genetic testing has skyrocketed. For Medicare, the public insurance program for elderly and disabled Americans, payouts for genetic tests jumped from $480 million in 2015 to $1.1 billion in 2018, a Reuters analysis found. Those figures do not include invoices for spending by state Medicaid programs, which serve the poor, or supplemental Medicare insurance programs offered by private insurers.

The investigations are examining billings submitted to federal health insurance programs. By law, all diagnostic lab tests must be ordered by a doctor treating a patient for a specific condition.

In the cases under review, investigators and patients told Reuters, marketers get elderly residents to turn over their Medicare or Medicaid information, along with their driver’s license and other identifying information, and tell them they will take a free cheek swab that can help them understand their risks of developing cancer or whether their genetics could unlock clues about how they will respond to drug treatments. They then get a doctor to sign off and approve the test and ship the swab off to a lab, which seeks Medicare payouts.

But many of the lab tests are not relevant to the patient’s history, and some of the doctors sign off on the results without conferring with the patient, said investigators familiar with the operations and patients interviewed by Reuters. Suspect companies pocket thousands, with a cut going to doctors, but the seniors get little, if any, benefit, investigators say.

Brian Benczkowski, the assistant attorney general for the U.S. Department of Justice’s Criminal Division, estimated that fraudulent billings submitted over the last few years are expected to total “north of $1 billion.” He called genetic testing of the elderly “the next big frontier in federal healthcare fraud enforcement.

A little-explored world surrounds the marketing companies, laboratories and telemedicine companies involved in elder genetic testing. Among them is Spectrum. Another is Clio Laboratories, the Georgia-based lab that is part of an interconnected network of labs, medical billing operations, a telemedicine firm and other healthcare-related limited liability companies, company records show.

In a handful of cases, the patients who had DNA samples sent to Clio or Spectrum said they never spoke with a doctor about why the cancer or pharmacogenetic tests were medically necessary. Moreover, when test results were completed, they were mailed directly to patients’ homes. That is not the norm, say doctors and medical experts. Usually, the ordering physician receives results first, then reviews them with the patient.

In 2017, the most recent data available, Clio billed Medicare $8.6 million for genetic testing and was paid about $4.6 million.

Some of the doctors involved in the genetic testing wave also have checkered pasts.  One California doctor was signing off on genetic tests for patients even as two states had disciplined him or were preparing to do so after he was criminally convicted in Los Angeles.

Orthopedic surgeon Dr. Mitchell G. Cohen pleaded guilty in November 2015 to filing a false tax return in connection with an illegal kickback scheme, cooperated with the government’s investigation, and later served more than eight months in a halfway house in central California through March 2019, court records show. Cohen was not charged with making an illegal kickback, but pleaded guilty to making a false tax return in a case federal authorities said involved kickbacks.

Cohen was approving genetic tests for Medicare patients during his stint in the halfway house and after his probation period ended. He approved the medical necessity of genetic tests handled by labs including BioConfirm in Georgia and Elite Medical Laboratories, lab records show.  He signed off on the genetic test for Elite in September 2018, as he was serving his sentence in the halfway house, records show. He approved the medical necessity of tests sent to Bioconfirm on May 10, 2019.