Case: In 2019, the feds indicted the owner of a Georgia lab for allegedly paying kickbacks to patient recruiters to engage in telemarketing campaigns and health fairs in an effort to drum up referrals of Medicare patients for medically unnecessary cancer genomic (CGx) BRCA tests and then billing Medicare for the tests. The owner asked the Florida federal district court to toss the indictment, claiming that:
- The payments to recruiters weren’t kickbacks but legitimate payments to “patient navigators” under the Affordable Care Act;
- The US Preventive Services Task Force recommends BRCA CGx testing for certain cases and Medicare is legally required to cover any screening tests the Task Force recommends; and
- Labs don’t have an independent duty to verify that ordered tests are medically necessary.
Not surprisingly, the court upheld the indictment.
Significance: Although the court suggested that the lab owner’s legal theories were way off base, especially the medically necessary argument, the refusal to dismiss the indictment was also based on procedural grounds to the extent that the arguments raised questions of fact that would have to be determined at trial [United States v. Patel, 2021 U.S. Dist. LEXIS 115925, 2021 WL 2550477