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A roundup of recent cases and enforcement actions involving the diagnostics industry
Referral Arrangement Violates Kickback Laws Even If Even Only Purpose Is to Generate Illegal Referrals Case: The U.S. Attorney accused a Kentucky physician of taking a $105 per beneficiary payment from a lab company in exchange for ordering its pharmacogenetic tests in violation of the Anti-Kickback Statute (AKS). And since the company billed Medicare for the tests, the physician “caused” a fraudulent claim to be submitted in violation of the False Claims Act (FCA). The physician asked the court to dismiss the charge because the government didn’t allege that he entered into the fee arrangement for the “sole purpose” of generating illegal referrals. And if the underlying AKS violation wasn’t an actual violation, the subsequent billing by the lab for the tests wasn’t an FCA violation either, he reasoned. But… . . . read more
G2 Blog
EKRA Prosecution: What Does this Mean for the Laboratory Industry?
By Charles Dunham, IV, Shareholder at Greenberg Traurig, LLP & Benjamin Nipper, Associate at Greenberg Traurig, LLP In January 2020, the U.S. Department of Justice (DOJ) made its first public announcement of a prosecution under the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) of a former manager of a substance abuse treatment clinic, who pled guilty to violating multiple federal health care fraud laws. News of the charge and guilty plea may cause concern to the laboratory industry because no regulations or guidance have been released since its enactment in October 2018, despite concerns raised by industry stakeholders to both Congress and DOJ that the statutory provisions are unclear and conflict with long-standing safe harbors under the federal Anti-Kickback Statute (AKS). While the DOJ has not secured a conviction… . . . read more
Genomic Testing Utilization Is Low & Geographically Inconsistent but Not Just Due to Payor Coverage
Genomic testing is inconsistently utilized in the U.S., even in states with favorable coverage policies. Those are the findings of a report from the Personalized Medicine Coalition (PMC) released in early August. Conducted in partnership with the Blue Cross Blue Shield Association, Concert Genetics and Illumina, the project analyzed trends and potential barriers to genomic testing access and utilization across the U.S. While wide variation and lack of clarity in payer coverage policies present barriers to genomic testing, the report found that there may be other factors preventing greater adoption of such testing. The Diagnostic Challenge Because no two people are exactly the same, medical management must be personalized can’t be one size fits all. But the effectiveness of personalized medicine relies on utilization of genomic testing and other diagnostics to inform medical… . . . read more
Using Waivers to Avoid Getting Sued for COVID-19 Infections
PLEASE READ NOTICE TO ALL ENTRANTS AND USERS OF THESE LABORATORY FACILITIES EXCLUSION OF LIABILITY – ASSUMPTION OF RISK THESE CONDITIONS WILL AFFECT YOUR LEGAL RIGHTS INCLUDING THE RIGHT TO SUE OR CLAIM COMPENSATION FOR AN INJURY OR ILLNESS In these times of pandemic, signs and forms like this purporting to shield the owner of a facility against liability have become a fixture in workplaces and other facilities. You might even be using them at your own lab. The idea is to notify patients, vendors and other visitors (which, for simplicity’s sake, we’ll refer to collectively as “visitors”) that they’re entering the facility at their own risk and in so doing, waiving their rights to sue the owner for any illness or injury they suffer while on the premises. Of… . . . read more
Labs Lost Less & Will Recover More than Other Healthcare Sectors, Says New Report
Although it’s not exactly “Happy Days Are Here Again,” a new S&P report is predicting that the healthcare sector has seen the worst of the COVID-19 pandemic and won’t have to go through “a return to the lows of earlier stages of pandemic in late March/early April.” However, the report also says a full rebound to pre-pandemic levels probably won’t happen until a coronavirus vaccine becomes available. Not as Bad for Labs as It Was for Other Sub-Sectors The economic devastation that COVID-19 wrought on healthcare was unprecedented, according to the report, with outpatient surgeries declining by as much as 90 percent and hospital admissions dropping 60 percent. Physical therapy, home healthcare and dental services were also among the hardest hit. S&P doesn’t expect a full recovery for these sub-sectors… . . . read more
Lab’s Duty to Protect Returning Employees from COVID-19 Discrimination and Harassment
SITUATION Fully recovered from his bout with COVID-19, Max is thrilled and excited to return to his custodian job after 14 days of mandatory home isolation. But almost immediately, he senses that something is wrong. His co-workers shun him and leave the room the moment he enters. And, while hygiene and handwashing are de rigueur for all maintenance staff, Max alone is required douse his hands in germicide and don rubber gloves each time he touches a piece of equipment. Worse, his supervisor harasses him and calls him “virus boy.” After weeks of putting up with it, Max complains to lab management. But his complaints fall on deaf ears and he continues to be ostracized and made to take extraordinary safety and hygiene measures not required of anybody else. So,… . . . read more