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Enforcement, Investigations + Litigation in Health Care

Government and regulatory agencies have made detecting and prosecuting fraud, waste, and abuse a centerpiece of their enforcement efforts. The stakes are high, and government investigations are often bet-the-company endeavors. Robinson+Cole’s Health Care Enforcement + False Claims Act Litigation team has the experience and resources necessary to guide clients through government investigations and the defense of companies and individuals in civil and criminal enforcement matters.

Our Services

Our Health Care Enforcement + False Claims Act Litigation practice comprises a multidisciplinary group of attorneys who seamlessly work together to address our clients’ needs from various perspectives. We have health law, white-collar defense, litigation, and employment lawyers with significant experience in discretely conducting internal investigations and developing compliance plans to mitigate risk before the government becomes involved. And when government investigations arise, we have substantive experience defending companies in enforcement actions, negotiating resolutions, and aggressively litigating civil and criminal matters in federal and state courts.

We represent health care companies in federal and state civil and criminal investigations and litigation nationwide. We have represented clients before the Criminal and Civil divisions of the U.S. Department of Justice, U.S. Attorney’s Offices, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, state Medicaid Fraud Control Units, and state attorneys general offices throughout the country.

We defend a variety of health care providers, including clinical laboratories, medical device manufacturers, remote patient monitoring providers, durable medical equipment providers, hospitals, home health care agencies, physicians, pharmacies, and telehealth providers. We work with clients on all aspects of enforcement matters, responding to search warrants and civil investigative demands through resolution or trial. Member of our team have convinced prosecutors to decline cases and have successfully resolved many others through settlements that were favorable to our clients. We often handle parallel investigations involving civil litigation, administrative actions, and criminal investigations.

We have notable experience defending against allegations of offering or receiving kickbacks in violation of the Anti-Kickback Statute (AKS), violations of the Eliminating Kickbacks in Recovery Act (EKRA), unlawful financial relationships and self-referrals in violation of the Stark Law, filing false claims with government health care programs in violation of the False Claims Act, and receiving overpayments from government health care payors.

Our Team

Our attorneys have a wide variety of government and health care backgrounds and bring their varied enforcement experience to bear through a multidisciplinary approach. We actively speak and write about enforcement trends in the health care industry and participate in professional organizations that bring government and defense attorneys together.

Experience


Represented MD Labs in First Circuit Victory for Clinical Lab in False Claims Act Appeal

Successfully represented MD Labs and its owners in defending against False Claims Act allegations in U.S. ex rel. Omni Healthcare Inc. v. MD Spine Solutions LLC et al., securing summary judgment in the District of Massachusetts and a unanimous affirmation by the U.S. Court of Appeals for the First Circuit. This landmark decision clarified that clinical laboratories may rely on doctor’s orders to show that the test is “reasonable and necessary” and confirmed that commissions to independent contractors are not per se illegal — setting an important precedent for clinical laboratories nationwide.

Read More
Represented MD Labs in First Circuit Victory for Clinical Lab in False Claims Act Appeal

Publications


Keeping Cool When ICE Arrives: Basic Raid Response Strategies for Laboratories teaser
November 17, 2025

Keeping Cool When ICE Arrives: Basic Raid Response Strategies for Laboratories

The ColLABorative Brief
July 30, 2025

From Red Flags to Readiness: How Labs Can Stay Ahead of Audit Risks

Quadax Blog

With $1.2B in improper lab payments projected, payers are ramping up audits—putting clinical labs under intense scrutiny. In our recent webinar, Labs Under the Microscope: Staying Ready for Payer Audits, Ann Betzel (AVP of Client Engagement at Quadax) and I shared practical strategies to help labs stay ahead of audit risks—covering what triggers payer scrutiny, what auditors are really looking for, and how to ask the right questions of your revenue cycle management vendors. Why Payer Audits Are Targeting Labs Labs are currently the most audited healthcare sector, due to billing complexities and a high volume of claims submitted with insufficient documentation. They also had the highest projected improper payments across all healthcare service types. That puts a target on your back. Audit activity includes: Medicare TPE (Targeted Probe and Educate) audits UPIC (Unified Program Integrity Contractor) investigations RAC (Recovery Audit Contractor) reviews Commercial payer audits based on data mining and AI tools These reviews focus on trends like test frequency, missing requisition signatures, incorrect coding, and a lack of clear medical necessity which can trigger recoupment or billing suspensions. Common Audit Triggers for Clinical Labs Auditors are increasingly relying on data analytics and artificial intelligence to flag outliers. Labs may be selected for audits if they show: High utilization of uncommon lab codes Incomplete or unsigned test requisition forms Missing documentation for medical necessity Sudden spikes in volume or billing patterns Tests ordered outside payer policy guidelines (e.g., MolDX, LCDs) “We’re seeing insufficient documentation and missing medical necessity across the board,” shared Ann Betzel. “Labs rely on providers to supply this information, but if it’s missing or vague, it creates a significant compliance risk.” How to Respond When Audits Happen When a lab receives an audit request or ADR (Additional Documentation Request), how you respond can directly impact financial and legal outcomes. I recommend using a detailed, structured approach: Tell the reviewer exactly where the order is, where medical necessity is supported, and how the results were used in treatment. Make sure to confirm that all required documentation—such as test orders, results, and proof of medical necessity—is complete and accurate before submission. Take time to review the specific policy requirements of the payer to ensure compliance. When responding to an audit, include a cover letter that clearly walks through the supporting evidence to help guide the reviewer. If additional time is needed to collect documentation, don’t hesitate to request an extension. Most importantly, use the audit process as an opportunity to evaluate your broader billing and documentation practices for potential gaps or systemic issues. Build an Audit-Resilient Revenue Cycle The best way to avoid audit penalties is to stay audit-ready. That means: ✅ Conducting regular internal audits on lab billing workflows ✅ Educating provider clients on payer documentation standards ✅ Monitoring denials to identify patterns or payer policy changes ✅ Using data analytics to assess billing trends and reduce risk ✅ Staying up-to-date on Medicare, MolDX, and commercial payer guidelines Watch the Full Webinar Interested in learning more? You can access the full session recording here, Labs Under the Microscope: Staying Ready for Payer Audits. Re-published from the Quadax Blog.

Keeping Cool When ICE Arrives: Basic Raid Response Strategies for Laboratories teaser
November 17, 2025

Keeping Cool When ICE Arrives: Basic Raid Response Strategies for Laboratories

The ColLABorative Brief
July 30, 2025

From Red Flags to Readiness: How Labs Can Stay Ahead of Audit Risks

Quadax Blog

With $1.2B in improper lab payments projected, payers are ramping up audits—putting clinical labs under intense scrutiny. In our recent webinar, Labs Under the Microscope: Staying Ready for Payer Audits, Ann Betzel (AVP of Client Engagement at Quadax) and I shared practical strategies to help labs stay ahead of audit risks—covering what triggers payer scrutiny, what auditors are really looking for, and how to ask the right questions of your revenue cycle management vendors. Why Payer Audits Are Targeting Labs Labs are currently the most audited healthcare sector, due to billing complexities and a high volume of claims submitted with insufficient documentation. They also had the highest projected improper payments across all healthcare service types. That puts a target on your back. Audit activity includes: Medicare TPE (Targeted Probe and Educate) audits UPIC (Unified Program Integrity Contractor) investigations RAC (Recovery Audit Contractor) reviews Commercial payer audits based on data mining and AI tools These reviews focus on trends like test frequency, missing requisition signatures, incorrect coding, and a lack of clear medical necessity which can trigger recoupment or billing suspensions. Common Audit Triggers for Clinical Labs Auditors are increasingly relying on data analytics and artificial intelligence to flag outliers. Labs may be selected for audits if they show: High utilization of uncommon lab codes Incomplete or unsigned test requisition forms Missing documentation for medical necessity Sudden spikes in volume or billing patterns Tests ordered outside payer policy guidelines (e.g., MolDX, LCDs) “We’re seeing insufficient documentation and missing medical necessity across the board,” shared Ann Betzel. “Labs rely on providers to supply this information, but if it’s missing or vague, it creates a significant compliance risk.” How to Respond When Audits Happen When a lab receives an audit request or ADR (Additional Documentation Request), how you respond can directly impact financial and legal outcomes. I recommend using a detailed, structured approach: Tell the reviewer exactly where the order is, where medical necessity is supported, and how the results were used in treatment. Make sure to confirm that all required documentation—such as test orders, results, and proof of medical necessity—is complete and accurate before submission. Take time to review the specific policy requirements of the payer to ensure compliance. When responding to an audit, include a cover letter that clearly walks through the supporting evidence to help guide the reviewer. If additional time is needed to collect documentation, don’t hesitate to request an extension. Most importantly, use the audit process as an opportunity to evaluate your broader billing and documentation practices for potential gaps or systemic issues. Build an Audit-Resilient Revenue Cycle The best way to avoid audit penalties is to stay audit-ready. That means: ✅ Conducting regular internal audits on lab billing workflows ✅ Educating provider clients on payer documentation standards ✅ Monitoring denials to identify patterns or payer policy changes ✅ Using data analytics to assess billing trends and reduce risk ✅ Staying up-to-date on Medicare, MolDX, and commercial payer guidelines Watch the Full Webinar Interested in learning more? You can access the full session recording here, Labs Under the Microscope: Staying Ready for Payer Audits. Re-published from the Quadax Blog.


News


April 22, 2026

Danielle Tangorre Explains Significance of Groundbreaking Decision for Clinical Laboratories

Health Care Enforcement + False Claims Act Litigation team member Danielle Tangorre spoke with The Dark Report and G2 Intelligence about the significance of the U.S. Court of Appeals for the First Circuit  in U.S. ex rel OMNI Healthcare v. MD Spine Solutions LLC, et al that came down in December 2025. The decision affirmed a lower court’s dismissal of a “high stakes” False Claims Act lawsuit, providing clarity for the diagnostic laboratory industry. Danielle, along with team members Edward J. Heath and Seth B. Orkand, represented MD Labs in the appeals case. Covering the decision from a legal risk perspective, The Dark Report said, “this decision creates a new 'safe harbor' for medical necessity while defining the specific boundaries where that protection ends.” Danielle explained the decision enshrined that “clinical laboratories can generally rely on a physician’s order as evidence that testing is reasonable and necessary…[T]hat’s significant because labs bill for tests but do not treat patients. They rely on the physician’s clinical judgment.” Danielle noted, however, that the relationship is collaborative and labs also have a corollary duty. Danielle also highlighted how the decision shifted the burden of proof, as the First Circuit Court focused specifically on the intent required for a lab to be held liable for fraud. “The court also clarified that if a lab relies on a physician’s order, the burden shifts to the relator to show the lab should not have relied on it—for example, if the lab influenced or usurped the physician’s decision-making,” said Tangorre. “That’s a major takeaway for laboratories.” Because Circuit Court rulings are often cited by other courts across the country, the decision provides a defensive blueprint for labs facing similar allegations. The decision “provides clarity on how courts view a lab’s role in certifying medical necessity while relying on physicians,” Danielle said.  “It essentially gives labs guardrails: Labs can rely on physician orders, but here’s where you can run into trouble. Organizations that operate cohesively and not in silos are in the best position to manage risk,” Danielle concluded. G2 Intelligence’s "Lab Industry Advisor,” another leading publication for the clinical lab industry examined the decision by focusing on compliance elements of the case. The article said a practical takeaway from the case for clinical lab directors involves the design of test requisition forms. “The courts emphasized that MD Labs did not improperly design its requisition. That’s an important lesson. Labs need to ensure requisitions are not steering or influencing test selection,” Danielle warned. “The same applies to marketing. Overpromising test value or implying broader clinical utility than supported can create risk, even if labs can generally rely on physician orders.” While the appellate ruling focused on medical necessity, it allowed the lower court’s findings on independent contractor commissions to stand. The clinical lab industry has long assumed that paying commissions to independent sales agents is “per se” violation of the Anti-Kickback Statue or the Eliminating Kickbacks in Recovery Act. The MD Labs case suggests that context and compliance matter most. “Importantly, the relator did not appeal the independent contractor issue, so the finding that commission payments are not inherently illegal stands,” Danielle pointed out. “That aligns with a growing trend in the courts: Sales commissions are not automatically violations of AKS or EKRA unless there is some additional improper conduct—what I call a ‘plus factor’—such as influencing ordering behavior.” The court was persuaded by the fact that MD Labs had a robust compliance framework, Danielle said. “Independent contractors were treated similarly to employees, and compliance oversight was robust,” she added. “That’s critical.”

Dark Report
G2 Intelligence’s Lab Industry Advisor
December 4, 2025

Health Care Enforcement Team Secures First Circuit Win for Clinical Lab in False Claims Act Appeal

January 27, 2025

Health Care Enforcement Team Wins Summary Judgment in Groundbreaking False Claims Act Litigation

Law.com, Law360, G2 Intelligence, The Dark Report, Laboratory Economics, and Massachusetts Lawyers Weekly
April 22, 2026

Danielle Tangorre Explains Significance of Groundbreaking Decision for Clinical Laboratories

Health Care Enforcement + False Claims Act Litigation team member Danielle Tangorre spoke with The Dark Report and G2 Intelligence about the significance of the U.S. Court of Appeals for the First Circuit  in U.S. ex rel OMNI Healthcare v. MD Spine Solutions LLC, et al that came down in December 2025. The decision affirmed a lower court’s dismissal of a “high stakes” False Claims Act lawsuit, providing clarity for the diagnostic laboratory industry. Danielle, along with team members Edward J. Heath and Seth B. Orkand, represented MD Labs in the appeals case. Covering the decision from a legal risk perspective, The Dark Report said, “this decision creates a new 'safe harbor' for medical necessity while defining the specific boundaries where that protection ends.” Danielle explained the decision enshrined that “clinical laboratories can generally rely on a physician’s order as evidence that testing is reasonable and necessary…[T]hat’s significant because labs bill for tests but do not treat patients. They rely on the physician’s clinical judgment.” Danielle noted, however, that the relationship is collaborative and labs also have a corollary duty. Danielle also highlighted how the decision shifted the burden of proof, as the First Circuit Court focused specifically on the intent required for a lab to be held liable for fraud. “The court also clarified that if a lab relies on a physician’s order, the burden shifts to the relator to show the lab should not have relied on it—for example, if the lab influenced or usurped the physician’s decision-making,” said Tangorre. “That’s a major takeaway for laboratories.” Because Circuit Court rulings are often cited by other courts across the country, the decision provides a defensive blueprint for labs facing similar allegations. The decision “provides clarity on how courts view a lab’s role in certifying medical necessity while relying on physicians,” Danielle said.  “It essentially gives labs guardrails: Labs can rely on physician orders, but here’s where you can run into trouble. Organizations that operate cohesively and not in silos are in the best position to manage risk,” Danielle concluded. G2 Intelligence’s "Lab Industry Advisor,” another leading publication for the clinical lab industry examined the decision by focusing on compliance elements of the case. The article said a practical takeaway from the case for clinical lab directors involves the design of test requisition forms. “The courts emphasized that MD Labs did not improperly design its requisition. That’s an important lesson. Labs need to ensure requisitions are not steering or influencing test selection,” Danielle warned. “The same applies to marketing. Overpromising test value or implying broader clinical utility than supported can create risk, even if labs can generally rely on physician orders.” While the appellate ruling focused on medical necessity, it allowed the lower court’s findings on independent contractor commissions to stand. The clinical lab industry has long assumed that paying commissions to independent sales agents is “per se” violation of the Anti-Kickback Statue or the Eliminating Kickbacks in Recovery Act. The MD Labs case suggests that context and compliance matter most. “Importantly, the relator did not appeal the independent contractor issue, so the finding that commission payments are not inherently illegal stands,” Danielle pointed out. “That aligns with a growing trend in the courts: Sales commissions are not automatically violations of AKS or EKRA unless there is some additional improper conduct—what I call a ‘plus factor’—such as influencing ordering behavior.” The court was persuaded by the fact that MD Labs had a robust compliance framework, Danielle said. “Independent contractors were treated similarly to employees, and compliance oversight was robust,” she added. “That’s critical.”

Dark Report
G2 Intelligence’s Lab Industry Advisor
December 4, 2025

Health Care Enforcement Team Secures First Circuit Win for Clinical Lab in False Claims Act Appeal

January 27, 2025

Health Care Enforcement Team Wins Summary Judgment in Groundbreaking False Claims Act Litigation

Law.com, Law360, G2 Intelligence, The Dark Report, Laboratory Economics, and Massachusetts Lawyers Weekly

Events


Past

Under OIG Scrutiny: Translating 2025 Enforcement Trends Into Actionable Strategies for Laboratory Compliance, Test Utilization Optimization, and Enterprise-Wide Risk Mitigation in 2026

Apr 28 2026
2026 Executive War College
Past

The Slippery Slope to Enforcement: How Payor Audits Trigger Government Action—and How to Identify Compliance Risk Early

Apr 28 2026
2026 Executive War College
Past

Under OIG Scrutiny: Translating 2025 Enforcement Trends Into Actionable Strategies for Laboratory Compliance, Test Utilization Optimization, and Enterprise-Wide Risk Mitigation in 2026

Apr 28 2026
2026 Executive War College
Past

The Slippery Slope to Enforcement: How Payor Audits Trigger Government Action—and How to Identify Compliance Risk Early

Apr 28 2026
2026 Executive War College
Past

Recent Health Care Enforcement Trends for Clinical Laboratories, Durable Medical Equipment Suppliers and Remote Patient Monitoring Providers

Oct 9 2025
2025 AHLA Fraud and Compliance Forum
Past

Recent Health Care Enforcement Trends for Clinical Laboratories, Durable Medical Equipment Suppliers and Remote Patient Monitoring Providers

Oct 9 2025
2025 AHLA Fraud and Compliance Forum