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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 sbhatia@bmdllc.com or 216.658.2214.


Name, Image, and Likeness Agreements in Healthcare

For example, some healthcare providers have begun to utilize "Name, Image, and Likeness" agreements to promote the brand they have created through their healthcare practice.  We have seen the most healthcare NIL activity with longevity and wellness providers, as well as orthopedics.

Compounding GLP-1 Drugs - Recent Updates

Recent guidance from the Ohio Board of Pharmacy (“BOP”) indicates that providers should generally use the FDA approved GLP-1 drug, rather than a non-FDA approved compounded version of the medication. Importantly, if a GLP-1 drug is commercially available, it cannot be copied through compounding. Currently, compounded copies of Tirzepatide and Semaglutide are not permitted.

Top Compliance Risks for Ohio Med-Spas in 2025

The Ohio Board of Pharmacy has increased inspections of med-spas holding Terminal Distributor of Dangerous Drugs (TDDD) licenses, with many facing enforcement actions in 2025. Common issues include purchasing from unlicensed distributors, improper drug storage, inadequate recordkeeping, and insufficient prescriber oversight. Understanding these risks and maintaining compliance can help protect your practice from penalties and license suspension.

Pre and Postnuptial Agreements | Necessary, Maybe, What Happened to Forever?

Both Florida and Ohio now allow clients to enter into a prenuptial or postnuptial agreement prior to marriage or after marriage (Ohio previously did not allow postnuptial agreements). Both documents have statutory guidelines that must be followed in terms of execution and financial disclosure.

DHS Ends All Employment Authorization Auto-Extensions

Effective October 30, 2025, DHS ends all automatic work authorization renewals. The 540-day extension applies only to renewals filed before this date, and there is no grace period for expired EADs filed on or after October 30. Employers must audit EADs, train staff, ensure I-9 compliance, and plan for work authorization gaps. Penalties for noncompliance can be severe.