Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny for the industry.

Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit healthcare fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing.

Marketers aren’t the only people targeted by law enforcement; physicians and other ordering providers are prosecuted too. Genetic tests may only be performed after a physician has established a relationship with a patient and determined that the tests are medically necessary. Insurers have guidance as to what establishes whether a test is medically necessary based on a multitude of factors. The fact that great uncle Joe had pancreatic cancer is not enough to establish medical necessity. Physicians are being criminally prosecuted and losing their medical licenses because they are not taking the time the time to establish a doctor-patient relationship with a patient, or are not well-versed in the information they must document to establish medical necessity. Physicians are being criminally prosecuted for kickbacks, too. Just a few days ago, a Maryland newspaper reported that a former laboratory executive has been indicted on federal charges alleging he paid physicians kickbacks to induce them to order unnecessary genetic tests for Medicare and Medicaid recipients.

We hear time and time again that the insurance companies are paying without evidence of medical necessity. But even if insurance companies are paying the claims now, labs should know that at some point they will be asked to produce records beyond the requisition form to establish that the claim for payment is valid. And if the lab can’t produce the record to satisfy the insurance company, the lab will have to pay the money back. If the lab is in-network, or the insurer is Medicare, the insurance company will not pay for future claims until the past claims are settled.

Prosecutions are on the rise, and the industry continues to expand. There are ways to compliantly market to consumers interested in genetic testing, to determine whether those consumers are candidates for genetic testing, and to provide those genetic tests. Every single step in the process must be analyzed to ensure that only persons who require testing are provided testing.