Categories
Health Law Highlights

OIG Updates Fraud and Abuse Authorities FAQs

Summary of article from King & Spalding, by Doug Comin:

On July 8, 2024, the Office of Inspector General (OIG) updated its Frequently Asked Questions regarding fraud and abuse authorities, adding four new questions and answers. The updates address the legality and conditions under which hospitals may waive cost-sharing charges for patients under financial assistance or charity care policies without violating the federal anti-kickback statute (AKS) or the Civil Monetary Penalty Law (CMP Law). OIG clarifies that waivers for uninsured or commercially insured patients generally do not violate these laws, but waivers for Federal health care program enrollees could be problematic unless they fall under specific safe harbors or exceptions. Hospitals can inform patients about financial assistance policies, provided such information is not advertised or solicited in a manner that could be construed as inducement. Additionally, offering free care to uninsured or commercially insured patients and advertising this care does not violate AKS or CMP Law. Finally, hospitals may disseminate information about financial assistance policies through various channels, ensuring the communication is compliant and low-risk under the relevant statutes. The full FAQs can be accessed on the OIG website.

Categories
Health Law Highlights

Vanishing Texas Companies Linked to Millions in Fraudulent Medicare Billings

Summary of article from MSN, by Brian New:

CBS News Texas’ investigation into alleged Medicare fraud uncovered over $200 million in fraudulent activities linked to several companies, prompting numerous viewers to report their own experiences with Medicare fraud. A subsequent report identified 11 additional Texas-based medical supply companies potentially involved in fraudulent practices. Many of these companies, such as Lone Star Medlab Laboratories and Peak Health Diagnostics, were found to have vacated their offices and disconnected their contact numbers. Aids for Recovery faced numerous complaints for fraudulent billing and had abandoned their office, leaving behind unopened Medicare correspondence. The Centers for Medicare & Medicaid Services (CMS) confirmed ongoing investigations into these companies, suspected of nearly $3 billion in fraudulent catheter billing.

Categories
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.

Categories
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.

Categories
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.

Categories
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.

Categories
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.

Categories
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.

Categories
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.

Categories
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.