During the Federal Bar Association’s annual Qui Tam Conference on February 23, 2022, Gregory E. Demske, Chief Counsel to the Inspector General for the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG), discussed OIG’s role in False Claims Act (FCA) enforcement, as well as enforcement priorities…
On February 22, 2022, the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical devices marketed pursuant to either Emergency Use Authorization (EUA) or Enforcement Policies during the COVID-19 public health emergency (PHE). The primary purposes of the webinar were to help prepare…
Physician referrals for clinical laboratory services are a common focus of federal regulatory and enforcement actions. Numerous statutes and their implementing regulations, including the Stark Law, Anti-Kickback Statute (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA), may be implicated where a physician refers clinical lab services to an entity…
The Department of Health and Human Services (HHS) has again delayed implementation of a rule that would cause it to review many of its regulations and would eliminate regulations that HHS fails to review. The rule had the potential to remove many non-statutory restrictions that HHS has placed on the…
When a Medicare contractor denies a claim, whether as part of a pre-pay, post-pay, Targeted Probe and Educate, statistically extrapolated, or other type of review or audit, the provider generally has a right to a lengthy appeal process. The process is complex and often relies on strictly enforced deadlines and…
The Centers for Medicare & Medicaid Services (CMS) contracts with a Supplemental Medical Review Contractor (SMRC), which performs a variety of Medicare and Medicaid audit and medical review tasks. Noridian Healthcare Solutions, which is also a Medicare Administrative Contractor (MAC), was selected as the SMRC in 2018. The SMRC conducts…
The Eliminating Kickbacks in Recovery Act (“EKRA”) is an incredibly broad and incredibly vague criminal statute that continues to create compliance issues for clinical laboratories. Many arrangements between clinical laboratories and other entities that were previously compliant, or which are currently authorized under other federal statutes, may be unlawful under…
Healthcare companies were once again the leading source of the Department of Justice’s (DOJ) False Claims Act (FCA) settlements and judgments last year. According to a DOJ news release, healthcare companies paid almost 90% of fraud settlement proceeds under the FCA in 2021. The Justice Department obtained more than $5.6…
The Department of Health and Human Services (HHS) recently announced additional audits of certain healthcare providers that received funding from the Provider Relief Fund (PRF). These audits will focus on whether hospitals that received PRF payments have complied with the surprise billing provisions of the PRF terms and conditions. HHS…
A phenomenon in Medicare audits that is gaining increased visibility is Medicare contractors “double-dipping” from providers by using overlapping audits. Once viewed as isolated aberrations, it is becoming increasingly common for Medicare contractors to audit and deny the same claims twice in different audits. This practice generally leads to overpayment…