Wanna know how often we’re asked whether the laws re healthcare marketing are really enforced? How often we hear “Everyone is doing it.” “Surely they [regulators] understand that every healthcare business has to market its services and item,” we’re told. And when we start to educate people re the state and federal laws that pertain to marketing healthcare items and services (INCLUDING those for which payment isn’t made by a state or federal healthcare program), their impatience and intolerance is palpable.
Take a look at the latest report from the Department of Justice guilty plea from someone who marketed the services of a genetic testing lab. He admitted being guilty of receiving over $300K in kickback money (presumably in the form of marketing fees) and now faces (1) a $250K fine, (2) returning all the money he received, and (3) five years in prison!
Marketing any healthcare service or item is at the tip of the sword in terms of regulatory investigation and enforcement. It’s that simple. And so when your lawyers drag you through laws like the Anti-Kickback Statute, the Florida Patient Brokering Act, the federal health insurance fraud law, the bona fide employee exception, the personal services arrangement and management contract safe harbor and EKRA, thank them! And expect nothing less. If you do ANYTHING at all in the neighborhood of marketing a healthcare item or services, the first place to start is: meet with a very experienced healthcare lawyer who is not learning on your dime. And have them take a couple hours to educate you about the laws, the options and the risks of each one. And once you’ve done that, ask them what more you can do to reduce your risk, for instance—
With a global pandemic, you can imagine the overwhelm and increase workload of laboratories. From the start, and even until today, COVID-19 testing has kept laboratory business operations busy. Join “The Lab Guy,” attorney Dean Viskovich for this informative webinar on how COVID-19 has impacted laboratories over the last eight months and what you can do to stay compliant.
On October 6, 2020, the Unites States Attorney’s Office of the Western District of Louisiana announced that George M “Trey” Fluitt III of Monroe, Louisiana was indicted. The federal grand jury indicted the lab owner for paying bribes and kickbacks in violation of the Anti-Kickback Statute, resulting in improper Medicare billing of approximately $117 million. Fluitt was the owner and operator of Specialty Drug Testing, LLC and is alleged to have solicited paid kickbacks and bribes in return for patient DNA specimens and physicians’ orders for cancer genetic and pharmacogenetic testing. Medicare allegedly paid Specialty Drug Testing, LLC $28,726,299 as a result of the fraudulent claims. If convicted, the defendant faces up to five years in prison for each count of conspiracy to defraud a healthcare program. Fluitt also faces 10 years in prison for illegal kickbacks, a $250,00 fine, forfeiture and restitution.
COVID-19 has affected all aspects of everyday life and healthcare rules and regulations are no exception. All areas of healthcare have been impacted, including the patient’s financial responsibility for healthcare services in the form of co-insurance, copays and deductibles. The waiver of a patient’s financial responsibility for healthcare services is regulated by federal and state law. The waiver of co-pays, co-insurance and deductibles has been deemed a violation of the federal Anti-Kickback statue. A provider who routinely waives the patient’s financial obligation may be violating the participating provider agreement with commercial carriers, state law and federal law with respect to Medicare beneficiaries. Waiving patient fees is seen as an inducement to the patient to prefer one provider over another for financial reasons. However, The Centers for Medicare and Medicaid Services (CMS) and commercial carriers have been authorized by the federal government to waive patient financial responsibility during the pandemic in order to encourage the public to get treated for COVID-19 and non-COVID medical conditions without fear of a hefty bill.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.