Genuine Genetic Testing Under Scrutiny

April 12, 2024 General

Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment and disease prevention. For example, genetic testing can help identify genetic mutations associated with certain diseases or conditions before symptoms appear, and it can help predict how an individual will respond to certain medications based on their genetic profile. However, the rapid growth in the number of tests available has invited well-earned scrutiny from law enforce.

The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call center operators and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients.

An ordering provider’s relationship with a patient, accurate and effective communication, and follow up are imperative if the patient will undergo genetic testing. Below are a few examples of how lab industry professionals have been caught in fraudulent prosecutions:

· Genetic tests may only be performed after a physician has established a relationship with a patient and determined that the tests are medically necessary and typically requires informed consent from the individual undergoing testing. Fraudulent practices might involve obtaining consent through deception or withholding important information about the risks and limitations of the test.

· Persons involved in the genetic testing industry may pursue purely financial gain by encouraging individuals to undergo genetic testing when it is not medically necessary. This could involve offering unnecessary follow-up tests, consultations, or treatments based on the results of the initial test.

· Misrepresentation of a test’s applicability can occur if a lab, ordering provider, or marketer falsely claims that a genetic test can provide certain information or insights that it cannot actually deliver. For example, one might claim that a test can accurately predict an individual’s risk for a certain disease when scientific evidence does not support such a claim.

One other important item to note. Because genetic testing is a lucrative venture for persons billing Medicare, it is crucial for laboratories to ensure that the specimens they are testing are bona fide. Under Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), Title 42, United States Code, Section 1320a-7b(b)(4) (“MACRA”), it illegal to buy, sell, or distribute Medicare beneficiary identification numbers without proper authority. Unscrupulous actors are using “data mining” and “social engineering” to collect Medicare beneficiary information, and then selling that information. Just last year, a man here in Palm Beach County was sentenced to 41 months in prison for engaging in such behavior on behalf of a laboratory. Laboratories should be regularly reviewing interactions with beneficiaries to ensure that they are the result of a genuine laboratory representative and a genuine patient.

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. If you’re involved in the genetic testing space, it is imperative that your processes are examined for any soft spots.