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Sharp Rise in False Claims Act Cases - Navigating the FCA Waters

Client Alert

The Department of Justice has announced that False Claims Act (FCA) settlements and judgments exceeded $2 billion in the Fiscal Year 2022 and $5.6 billion in the Fiscal Year 2021. A large portion of such settlements and judgments involve healthcare businesses such as physician practices, hospitals, and pharmacies. The number of FCA cases has increased over the past several years, and it is evident that governments on both the state and federal levels are becoming more aggressive in their use of the FCA to obtain recoveries.

The FCA, 31 U.S.C. § 3729 et seq., was enacted in 1863 during the Civil War to counteract fraud by companies selling supplies to the Union Army. War profiteers would swindle the Union Army by providing rotten food, worn-out garments, and defective weapons. Today, the FCA is one of the government's strongest anti-fraud statutes. It imposes liability on individuals and businesses that defraud and cause financial loss to the federal government. The FCA also provides the potential for rewards for whistleblowers who report such fraudulent activities.

FCA claims can also be a source of stress and complication for businesses when they find themselves to be the target of either a federal investigation or state investigation. Whenever there is government money at stake, there is a chance for an FCA claim. Among other industries, FCA investigations are commonly seen among healthcare businesses that bill state and federal healthcare programs, such as Medicare and Medicaid. Since fraud in the healthcare industry can lead to rising healthcare costs, the government is keen on cracking down on such activity.

Recently, on April 18, 2023, the United States Supreme Court heard arguments regarding the FCA’s scienter, or mental state, requirement. To prove violation of the FCA, the statute requires that a defendant “knowingly” file false claims for payment. The term “knowingly” is defined within the statute to mean a person that acts with actual knowledge, deliberate ignorance, or reckless disregard. Circuit courts are split on how to interpret and apply the knowledge element of the FCA, and based on the Supreme Court’s decision, there will be a large impact on healthcare defendants and their businesses as well as anyone who contracts with, or receives money from, a federal program. A broader interpretation of the FCA would unnecessarily target and stifle healthcare, and other businesses, for simple errors in daily operations. This goes against the intended application of the FCA, which was to prevent fraudulent activity.

Violation of the FCA can potentially lead to liability for treble damages, or three times the actual losses, so it is imperative to have the proper legal counsel as you navigate the FCA waters. Whether you are facing allegations of violating the FCA or you want to put in place safeguards to ensure your business does not face such allegations, our team and BMD is ready, willing, and able to help. Our team has experience successfully defending against FCA claims and large qui tam cases, and they would be happy to discuss any concerns you may have. Questions should be directed to Shalini Bhatia at or 216.658.2214.

Starting an Advanced Practice Provider Practice

Advanced practice providers (APPs), which includes non-physician providers such as nurse practitioners, physician assistants, and nurse anesthetists, commonly start their own healthcare practices. Practices may provide, for example, service offerings such as primary care, anesthesiology, mental health, and aesthetics (medical spas). However, there are a number of considerations and steps that must be taken for APPs to compliantly function independently.

FTC Increases Targeting of Companies Lacking Cyber Protection

The Federal Trade Commission (FTC) recently released a comprehensive cybersecurity report outlining key findings and recommendations based on emerging threats, trends in data breaches, and strategies for businesses to enhance their cybersecurity posture observed over the last year.

New Federal Medical Conscience Rule and Its Implications

The Department of Health and Human Services Office for Civil Rights issued a Final Rule to clarify protections for healthcare providers who refuse services based on religious or moral beliefs. This includes protection against discrimination for refusing procedures like assisted suicide or abortion. The OCR can receive complaints, conduct investigations, and enforce these protections. Entities are encouraged to update policies accordingly and display a model notice provided by the OCR.

Marijuana Reclassification and APRN/PA Prescribing

Marijuana is expected to be reclassified by the Drug Enforcement Administration (DEA) from a Schedule I controlled substance to a Schedule III controlled substance as a result of efforts by the Biden administration.

Federal Trade Commission Voids Non-Compete Agreements Nationwide

On April 23, 2024, the U.S. Federal Trade Commission (“FTC”) issued its Final Rule containing regulations impacting non-compete agreements across the country for all employees. The Final Rule implements some of the most impactful changes to employment law during this century. The Final Rule will take effect 120 days from its publication in the Federal Register, which we expect to occur within the next few weeks.