August 2019

Since the United States Department of Health and Human Services Office of Inspector General (HHS-OIG) alerted the industry about genetic testing scams two months ago, the public, multiple government agencies, and Congress remain vigilant of these schemes. In a June 3, 2019 Fraud Alert, the HHS-OIG warned of Medicare fraud schemes whereby Medicare beneficiaries are offered free genetic screenings or testing to obtain their information for fraudulent billing or identity theft. These schemes may be accomplished through health fairs, door-to-door visits, or telemarketing calls that target Medicare beneficiaries. Of concern is that the tests are not medically necessary or ordered by a physician.

In a July 19, 2019 blog post, the Federal Trade Commission (FTC) brought to attention callers claiming to be from Medicare seeking personal information for genetic testing kits. A day prior to the FTC’s blog post, the Oregon Department of Justice (DOJ) also cautioned against the genetic testing fraud schemes.

Most recently, on August 12, 2019, Congressional members expressed their concern about genetic testing in a letter to HHS and the United States DOJ. Senators Bill Cassidy, Margaret Wood Hassan, and Sheldon Whitehouse wrote to these departments seeking additional information on (i) the awareness and mechanics of the ongoing fraud schemes, (ii) how the Centers for Medicare & Medicaid Services confirms medical necessity and ordering physicians of genetic tests, (iii) detection of fraudulent ordering of genetic testing, (iv) participation of labs and genetic test manufacturers in arrangements with physicians to order tests, and (v) safeguards HHS and other agencies are developing to address the fraud schemes.

HHS-OIG’s issuance of the Fraud Alert and later Government follow-up is not just a warning to be wary of the genetic testing fraud schemes, but also a reminder to the industry that genetic tests must meet Medicare requirements like medical necessity and be ordered by a treating physician. It is also an indication that government agencies are devoting increased attention to genetic testing, which may lead to scrutiny of and enforcement actions against providers, laboratories, and manufacturers.