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Health Law Highlights

False Claims Act Settlements to Know from Q2 2024

Summary of article from Bass, Berry & Sims PLC, by Latazia Carter, Scott Gallisdorfer:

In Q2 2024, the Department of Justice announced significant False Claims Act settlements, highlighting ongoing enforcement in areas such as unlawful kickbacks, improper billing, and subcontracting violations. Notable settlements included a $27.9 million agreement with a laboratory owner for fraudulent cancer genomic tests and a $12 million settlement with Innovasis Inc. for paying kickbacks to spine surgeons. Cape Cod Hospital and a chronic disease management provider, facing Medicare billing violations, each entered into Corporate Integrity Agreements (CIAs) and paid $24.3 million and $14.9 million, respectively. Additionally, CityMD resolved COVID-19 testing fraud allegations with a $12 million settlement, and Sikorsky Services Inc. and Derco Aerospace Inc. paid $70 million for unlawful subcontracting practices in Navy procurement. These cases underscore the importance of compliance for entities engaged in government contracts and healthcare services.

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Health Law Highlights

Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful

Summary of article from Mintz, by Laurence J. Freedman, Laura E. Martin:

The Supreme Court has the opportunity to clarify the definition of “willfulness” under the Anti-Kickback Statute (AKS) in a case involving McKesson Corporation. The Second Circuit upheld the dismissal of a False Claims Act (FCA) case, ruling that “willfulness” under the AKS requires the defendant to know their conduct is unlawful. The petitioner, Adam Hart, argues that this interpretation is too stringent and seeks Supreme Court review to resolve a circuit split on the issue. The outcome could significantly impact the Department of Justice and relators’ ability to prove AKS violations as predicates for FCA claims. The case has attracted significant interest from various industry and legal groups, anticipating potential Supreme Court involvement.

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Health Law Highlights

Healthcare Execs Face Federal Drug Charges in Landmark Telehealth Case

Summary of article from Bradley Arant Boult Cummings LLP, by Jonathan Ferry, Stephen Moulton, Virginia Wright:

Federal prosecutors have charged two healthcare executives of Done Global Inc. and Done Health P.C., with unlawfully distributing controlled substances like Adderall via a telehealth platform. This unprecedented case highlights the Department of Justice’s focus on enforcing controlled substances laws within the digital health sector, particularly post-pandemic. The indictment alleges that Done exploited COVID-era regulatory waivers to facilitate easy access to ADHD medications without proper medical oversight, resulting in the unlawful distribution of over 40 million stimulant pills. This prosecution underscores the growing scrutiny of online prescription services and may set a precedent for future telehealth-related legal actions. The case raises critical issues regarding the balance between expanding access to mental health treatments and preventing prescription drug abuse.

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Alert

Eight Charged Locally as Part of National Health Care Fraud Enforcement Action

Press Release from United States Department of Justice, Southern District of Texas:

On June 27, 2024, the U.S. Attorney’s Office for the Southern District of Texas announced charges against eight individuals as part of the Justice Department’s 2024 National Health Care Fraud Enforcement Action. These charges involve various schemes, including fraudulent Medicare billing, kickbacks, and money laundering, amounting to over $2.75 billion in false billings nationwide. The accused include residents from Texas and Florida, with allegations ranging from operating fake businesses to billing for unprovided medical services. The enforcement action resulted in the seizure of over $231 million in assets. The FBI, Health and Human Services OIG, and other federal and state agencies conducted the investigations, while Assistant U.S. Attorneys and Department of Justice Trial Attorneys are prosecuting the cases.

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Health Law Highlights

Texas Medical Center Institutions Agree to Pay $15M Record Settlement Involving Concurrent Billing Claims for Critical Surgeries

Summary of article from U.S. Attorney’s Office, Southern District of Texas:

Baylor St. Luke’s Medical Center, Baylor College of Medicine, and Surgical Associates of Texas have agreed to a $15 million settlement to resolve allegations of improper concurrent billing for heart surgeries, violating Medicare regulations and informed consent rules. The investigation, initiated by a whistleblower complaint in 2019, revealed that surgeons Dr. Joseph Coselli, Dr. Joseph Lamelas, and Dr. David Ott allegedly ran multiple operating rooms simultaneously, improperly delegating critical tasks to unqualified residents and falsifying records. This practice, which occurred from June 2013 to December 2020, compromised patient safety and violated Medicare’s requirements for surgeon presence. The settlement, the largest of its kind, underscores the importance of adherence to medical regulations and accountability in healthcare. The whistleblower will receive over $3 million from the settlement.

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Health Law Highlights

Texas Company Connected to Alleged Scheme That Billed Medicare $3 Billion for Urinary Catheters

Summary of article from CBS Texas, by Brian New:

A Texas-based company, Konaniah Medical Supplies, is implicated in a suspected Medicare fraud scheme involving billing for urinary catheters that beneficiaries never ordered or received. The company, along with its associated entity G&I Ortho Supply in New York and eight other medical supply companies, collectively billed Medicare over $3 billion for catheters, causing a nearly 2,000% increase in Medicare billings for this product. The Centers for Medicare & Medicaid Services (CMS) have identified a concerning increase in urinary catheter billings and suspended payments to the implicated suppliers, but it remains unclear how much of the alleged fraudulent billings were paid out. U.S. Senator Mike Braun has called for a full federal audit of Medicare, and proposed a bill to use artificial intelligence for detecting potential billing irregularities. The investigation into the alleged fraud is ongoing.

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Ask the Health Lawyer

Stark Law-Based FCA Lawsuits Multiply: Relators Targeting Physician Compensation

Summary of article from Davis Wright Tremaine, by Robert G. Homchick, Adam D. Romney, Gavin Keene:

Several health systems, including Community Health Network Inc., University of Pittsburgh Medical Center, Erlanger Health System, and Steward Health Care System, have recently faced Stark Law-based False Claims Act (FCA) lawsuits. These lawsuits primarily focus on allegations of above fair market value compensation to physicians for referrals. The cases underscore the increased scrutiny of physician compensation practices and potential severe consequences of Stark Law violations. The trend suggests that health systems should reassess their risk levels arising from physician compensation practices. To mitigate risks, healthcare organizations should ensure fair and transparent compensation arrangements, implement effective compliance programs, take whistleblower claims seriously, and seek legal guidance to navigate Stark Law complexities.

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Health Law Highlights

How This Southlake Physician Ended Up Serving Federal Time

Summary of article from D Magazine, by Will Maddox:

Dr. Rodney Sosa, a Southlake physician, was convicted of defrauding the United States government and sentenced to 46 months in federal custody. The conviction was related to a telemedicine scheme involving unnecessary medical equipment and testing, for which he submitted $1.4 million worth of claims. His medical license was revoked in April 2024, following his sentencing in March. Sosa also allegedly practiced as a plastic surgeon at Ver Halen Aesthetics, despite his certification being in internal medicine. Investigations into Sosa’s activities at Ver Halen Aesthetics are ongoing.

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Health Law Highlights

Fort Worth Physicians Assistant Sentenced in Medicare Fraud Case

Summary of article from WFAA, by Ben Sawyers:

North Texas physician’s assistant, Ray Anthony Shoulders, was sentenced to seven years in federal prison on counts of healthcare fraud, after submitting $788,000 in fraudulent medical claims and receiving over $614,000 in Medicare reimbursements. Shoulders was found to be injecting patients with amniotic fluid, a non-FDA approved treatment, under the guise of pain management. He manipulated billing codes to claim reimbursements from Medicare, using codes for an approved product while actually using a non-approved one. The scam, which operated intermittently between August 2020 and October 2021, resulted in significant profits for the clinic. Shoulders was ordered to pay $614,235 in restitution.

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Health Law Highlights

Kickbacks and Medically Unnecessary Treatments: Five Major Qui Tam Settlements from May 2024

Summary of article from Kohn, Kohn & Colapinto LLP, by Geoff Schweller:

In May, the U.S. Department of Justice (DOJ) and U.S. Attorneys’ Offices announced several substantial settlements under the False Claims Act (FCA), resolving qui tam whistleblower lawsuits related to healthcare fraud. The settlements involved cases of kickbacks, billing for unnecessary treatments, and non-compliance with Medicare rules. Prominent cases included a $27 million settlement with Daniel Hurt for alleged Medicare fraud, a $24.3 million settlement with Cape Cod Hospital for non-compliance with Medicare rules, and a $12 million settlement with Innovasis Inc. for alleged kickbacks to surgeons. Other notable settlements involved RiverSpring and Elara Caring, which settled for $10.1 million and $4.2 million respectively. These settlements underscore the importance of whistleblowers in combating healthcare fraud, and highlight the significant financial burden and potential harm caused by fraudulent practices.