COVID is front and center in all aspects of everyday life and has shined light in the strangest of places that were usually in the dark. In healthcare the laboratory space has always taken a backseat to other sectors in terms of recognition and value. The current climate in the lab space has shifted and it is not an illusion, labs are front and center.
COVID has taken its toll on areas of the economy and investors are certainly one of the first to become aware of this situation. Clinical laboratories are currently an attractive acquisition target and the reasons are numerous, sectors like retail, entertainment and travel are performing poorly and investors are shifting their investment dollars into healthcare and technology. Investors are looking for growth and profitability and are finding it in healthcare. Mergers and Acquisitions (M&A) is nothing new in the lab industry, but now careful consideration is required when it comes to deciding the appropriate time to sell your lab.
The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans. The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs. The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished. Compliance plans offer a vehicle to achieve that goal. The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.
The OIG suggests that the comprehensive compliance program should include the following elements:
Laboratories nationwide are overwhelmed with increased diagnostic testing volume while simultaneously managing regulatory changes in light of the COVID-19 pandemic. It is more essential than ever for clinical laboratories to enforce regulation, have a compliance plan in place and develop or enhance operational policies. Our firm has expert lab lawyers with ‘insider’ healthcare business knowledge to help keep your business compliant while adapting to the rapidly changing healthcare landscape.
Download the laboratory compliance image as a PDF here.
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.
Effective July 1, 2018, Florida’s recent legislation SB 622 repeals the entirety of Chapter 483, Part I of the Florida statutes, and removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and so eliminates section 59A-7.024(1).
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.