Laws and regulations are present to better ensure diagnostic labs provide quality care. A failure to abide by these regulations can result in serious penalties. There are many government agencies that oversee these regulations. The United States Department of Health and Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are a few of the more prominent federal agencies that diagnostic labs may encounter.
Gravity Diagnostics, a CLIA diagnostic and testing laboratory licensed to provide services throughout the country, recently announced the addition of an executive. Although the addition of another executive for this large of an organization on its own is not of note, the job description for this position is: chief compliance officer. The lab's owners moved to hire this executive solely for the purpose of better ensuring the lab is compliant with all applicable regulations - both state and federal.
Lab owners must balance a multitude of tasks to have a successful business. They need to make sure they have the staff needed to run a safe, accurate and efficient facility. In addition to watching the bottom line, these entrepreneurs also need to have a basic understanding of applicable regulations. A failure to abide by these rules can result in allegations of fraud - which can come with serious penalties.
A diagnostic laboratory recently agreed to pay the government almost $12 million to settle claims that the health care company violated federal Anti-Kickback Statute (AKS) regulations. The government claimed that individuals within the diagnostic lab were illegally bribing health care professionals to use the professional services offered within their lab.
The United States Centers for Medicare and Medicaid Services (CMS) has rolled back some regulatory provisions in response to the current coronavirus pandemic. Officials reason that these rollbacks will help to better ensure patients can get the testing, diagnosis and treatment needed during these uncertain times.
The federal Anti-Kickback Statute (AKS) is a key piece of legislation used by the government to prosecute healthcare businesses and practitioners for fraud. The law is broad, and applies to services billed by physicians, nurses and even diagnostic labs.
The government has stated it is prepared to go after those who commit health care fraud to receive funds set aside to help deal with the coronavirus pandemic. True to its word, the Department of Justice (DOJ) has already reported one action against health care fraud related to the coronavirus. The agency states it moved forward with an action against a website offering a free vaccine against COVID-19 - patients need only pay the $4.95 shipping and handling fee. It has since ordered the website to shut down the offer.
The Department of Justice recently accused a medical equipment manufacturer of violating the Anti-Kickback Statute (AKS). Whistleblowers began the claim, accusing the company of paying monetary incentives to suppliers and labs to better ensure these medical professionals used their sleep apnea equipment.
A diagnostic lab is in financial ruin after an insurer accused the lab of paying illegal kickbacks in exchange for referrals. The accusations are part of a lawsuit that has led the lab to file for protection in bankruptcy court.
Diagnostic and clinical labs may experience a surge in growth in coming years. A market research company recently released findings after analyzing the industry and found key factors that it believes predict an upcoming surge.