From Supreme Court rulings to shifting political landscapes, here are 10 developments that could significantly impact how financial arrangements and referrals are regulated.
1. Record-high number of qui tam lawsuits
The year 2024 saw a surge in whistleblower-driven Stark law enforcement. Seven major Stark law indictments contributed to a record-breaking 979 qui tam lawsuits, with False Claims Act settlements and judgments totaling $2.92 billion by the federal government’s fiscal year-end on Sept. 30. This marks an increase from $2.79 billion in 2023 and is the highest enforcement total since 2021’s $5.69 billion.
2. Chevron deference reversal could reshape Stark law interpretation
The Supreme Court’s reversal of Chevron deference — a longstanding principle that required courts to defer to federal agencies’ regulatory interpretations — is already impacting Stark law cases. A False Claims Act lawsuit involving Thomas Health System in West Virginia has been delayed as judges now bear the burden of independently interpreting ambiguous regulations. This shift could lead to greater unpredictability in enforcement actions and compliance expectations.
3. Jarkesy v. SEC ruling may challenge Stark law penalties
The Supreme Court’s ruling in Jarkesy v. SEC has cast uncertainty over administrative penalties under Stark law, according to an October blog post from law firm WhiteFord. The decision found that civil monetary penalties imposed by the Securities and Exchange Commission violated the Seventh Amendment protecting the right to a jury trial. Legal experts suggest that this precedent could be applied to Stark law cases, opening new challenges to CMPs issued by federal agencies and potentially requiring stronger statutory justification for administrative fines.
4. A new administration could ease enforcement
According to a November report from the Healthcare Financial Management Association, enforcement of regulations set by the False Claims Act, Stark law and Anti-Kickback Statute may be “applied less rigorously” under a Trump presidency.
Retired physician executive Thomas Stover, MD, told Becker’s a Trump presidency could mean a “potential repeal of much of the Stark law, given the current environment of employed physicians.”
5. New non-monetary compensation limits for 2025
ASCs, physician groups and hospitals can provide non-monetary compensation to physicians up to an amount of $519 for the calendar year 2025, according to a Dec. 30 blog post from law firm Hall Render. This cap applies to gifts, meals and other non-cash benefits provided to physicians by ASCs, hospitals and medical groups.
6. Value-based care poses compliance risks
Financial incentives for anesthesia providers in value-based care models may conflict with existing fraud and abuse laws, including Stark law. Healthcare professionals must be vigilant to ensure compliance with these evolving regulations. Here‘s what anesthesia providers know about the potential legal dangers of value-based care arrangements.
7. Private equity faces increased Stark law scrutiny
In October, Kathleen Fisher Enyeart, counsel at Lathrop GPM, spoke with JDSupra to highlight key healthcare regulatory trends. She told the publication she foresees more regulatory focus on potential Stark law violations. The Stark law poses significant risks to private equity investors unfamiliar with healthcare’s complex legal framework — physicians in private equity-owned groups must be vigilant about how these financial arrangements are structured to avoid legal pitfalls.
8. ASCs face complex compliance challenges
ASCs, especially multispecialty facilities, must carefully navigate ownership transactions to avoid Stark Law violations. Ensuring compliance in these deals is crucial to mitigating regulatory risks. Here are five important considerations to know for ASCs to avoid Stark law compliance issues.
9. DOJ could be refocusing on Stark law enforcement
The Department of Justice is moving away from prosecuting COVID-19 pandemic-related fraud and refocusing on unlawful marketing and referral practices, including Stark Law violations, Law.com reported Nov. 7. The recent reelection of Donald Trump is unlikely to shift AKS’ role as a major weapon in the Department of Justice’s “arsenal of healthcare fraud enforcement,” the report said. But for life sciences and other health services companies, AKS enforcement is entering a new era.
10. Self-disclosures are surging
In 2023, CMS resolved $12.56 million in Stark law-related voluntary self-disclosures, a staggering 552% increase since 2021. DOJ enforcement has similarly intensified, with at least 10 multimillion-dollar settlements reported over the past two years. Financial relationships, particularly those involving physician compensation that exceed fair market value or vary based on referrals, are key areas of concern.
