As a lawyer who has defended healthcare professionals across the country, I’ve seen firsthand how Stark law enforcement can turn a well-intentioned business decision into a legal nightmare. Physicians, ambulatory surgical centers (ASCs), and healthcare executives are facing more scrutiny than ever, and the margin for error is razor-thin. The rules keep changing, and regulators are becoming more aggressive in their pursuit of alleged violations. If you’re a physician or compliance officer reading this, I know the stress that comes with these investigations—and I want to help you navigate this evolving landscape.
Here are ten key developments that could dramatically impact your practice and financial arrangements.
1. Surge in Whistleblower Lawsuits
The number of whistleblower-driven Stark law cases is skyrocketing. In 2024, federal prosecutors filed a record-breaking 979 qui tam lawsuits, leading to False Claims Act settlements totaling $2.92 billion. I’ve handled cases where a disgruntled employee or a former business partner initiated a qui tam action, turning what could have been an internal compliance issue into a full-blown federal investigation. If you’re a healthcare professional, it’s critical to understand how these cases develop—and how to protect yourself.
2. Supreme Court’s Chevron Deference Reversal Creates Uncertainty
The Supreme Court’s decision to overturn Chevron deference is already shifting the landscape for Stark law compliance. Historically, courts deferred to federal agencies when interpreting complex regulations, but now judges are tasked with making independent determinations. This means enforcement actions could become less predictable, and I expect to see an increase in legal battles over ambiguous Stark law provisions. If you’re a healthcare provider, you can no longer assume the government’s interpretation will hold—each case will need to be fought on its own merits.
3. Stark Law Penalties May Face Constitutional Challenge
A recent Supreme Court ruling in Jarkesy v. SEC challenges the authority of administrative penalties, potentially impacting Stark law enforcement. If civil monetary penalties under Stark law are deemed unconstitutional, it could change how cases are prosecuted. This presents new defense strategies for providers facing Stark law allegations, and I’m closely watching how this precedent will influence future cases.
4. A Potential Shift in Enforcement Under a New Administration
Political shifts always influence healthcare enforcement. A Trump presidency could bring less regulatory aggression, but I advise my clients not to bet on deregulation. Healthcare fraud enforcement is a multi-billion-dollar industry for the government, and I’ve seen administrations from both parties continue to prioritize Stark law violations. Regardless of who is in office, compliance must remain a top priority.
5. New Non-Monetary Compensation Limits for 2025
Healthcare providers must be mindful of new non-monetary compensation limits in 2025. ASCs, hospitals, and physician groups can provide up to $519 in non-cash benefits before triggering compliance concerns. I’ve represented clients who unknowingly crossed these thresholds, leading to costly legal battles. If you provide or receive non-monetary compensation, document everything and ensure you’re within the allowable limits.
6. Compliance Risks in Value-Based Care Arrangements
As healthcare shifts toward value-based care, new Stark law risks emerge. I’ve advised clients on financial incentive structures that align with compliance standards, but many providers still operate in legal gray areas. If you’re an anesthesia provider or part of a value-based care arrangement, ensure your financial models don’t inadvertently violate Stark law or the Anti-Kickback Statute.
7. Private Equity Under Increased Stark Law Scrutiny
Private equity-backed physician groups are facing more scrutiny than ever. I’ve worked with private equity firms navigating Stark law risks, and I can tell you that many investors underestimate the regulatory landmines in healthcare. Physicians in private equity-owned practices must ensure their contracts and financial structures are fully compliant to avoid enforcement actions.
8. ASCs Face Increasingly Complex Compliance Challenges
ASCs must tread carefully in ownership transactions to avoid Stark law violations. I’ve represented ASC owners who faced government inquiries due to seemingly minor compliance missteps. The key to avoiding issues is proactive compliance—ensuring referral relationships and compensation structures are fully documented and vetted by legal experts.
9. DOJ Shifts Focus Back to Stark Law Enforcement
The DOJ is refocusing its efforts on Stark law violations, particularly in life sciences and medical service industries. I’ve seen this shift firsthand, with federal prosecutors taking a hardline stance on referral arrangements. If you’re involved in healthcare marketing, referral programs, or joint ventures, now is the time to reevaluate your compliance strategy.
10. Self-Disclosures Are on the Rise
More healthcare organizations are voluntarily disclosing Stark law violations, with CMS resolving $12.56 million in self-disclosures in 2023. I often advise clients on whether self-disclosure is the right path—sometimes it mitigates penalties, but in other cases, it opens the door to greater scrutiny. If you suspect a Stark law issue, consult an experienced attorney before making any disclosures.
Protect Your Practice with Experienced Legal Defense
Stark law compliance is more than just an administrative burden—it’s a legal minefield. I’ve defended healthcare professionals across the country who never thought they’d end up in the government’s crosshairs. The reality is that even well-meaning providers can get caught up in complex regulations. At Safe Harbor Group, we provide the legal expertise you need to stay ahead of compliance risks, respond to government investigations, and protect your career.
Don’t wait for an investigation to take compliance seriously—contact me today and let’s build a strategy to safeguard your practice.
