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Clinical Laboratories + Pathology Laboratories

Strategic Counsel for a Rapidly Evolving Regulatory Landscape 

At Robinson+Cole, we provide comprehensive legal support to clinical and pathology laboratories traversing the complex and ever-evolving regulatory environment. Our cross-disciplinary team advises on transactional structuring, regulatory compliance, and litigation defense — helping our clients remain compliant, competitive, and protected. Our team services laboratories to address their business needs in a compliant manner to navigate operational and legal challenges. 

We regularly publish in laboratory journals, speak at industry events, and lead webinars — ensuring our team stays at the forefront of regulatory and legal trends.  

Our Services for Clinical Laboratories 

Our firm provides strategic counsel to clinical and pathology laboratories. With our industry insight and regulatory fluency, we help clients structure deals that align with both their business goals and compliance obligations. Such services include, but are not limited to: 

Transactional 

  • Structuring joint ventures, acquisitions, and affiliations; 
  • Drafting and negotiating laboratory service agreements and marketing agreements; and
  • Conducting regulatory and compliance due diligence. 

Regulatory Compliance 

  • Advising on reimbursement issues, lab-to-lab billing requirements, and overall billing compliance; 
  • Reviewing and drafting sales and marketing practices and advising on compliance;
  • Counseling on the Anti-Kickback Statute, the Stark Law, the Eliminating Kickbacks in Recovery Act, and other fraud and abuse laws; 
  • Developing compliance plans and training; 
  • Providing guidance on CLIA certification and state licensure; 
  • Advising on HIPAA (Health Insurance Portability and Accountability Act) and data privacy compliance; 
  • Assisting with internal compliance audits and policy development; and  
  • Providing representation before CMS and in state agency matters. 

Litigation and Enforcement Defense 

  • Defending against government investigations and enforcement actions; 
  • Responding to audits, subpoenas, and qui tam complaints; 
  • Negotiating corporate integrity agreements and other settlements with the U.S. Department of Health and Human Services Office of Inspector General; and
  • Managing appeals of adverse regulatory determinations. 

Why Clients Choose Us 

  • Long-standing industry knowledge: Our attorneys understand the operational realities of clinical and pathology  labs. 
  • Proactive risk management: We help clients anticipate and mitigate compliance risks before they escalate. 
  • Integrated legal solutions: From deal structuring to defense strategy, we offer end-to-end support. 

People

Portrait of Danielle H. Tangorre

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

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back teaser
February 3, 2026

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back

The ColLABorative Brief
DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025 teaser
February 2, 2026

DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

The ColLABorative Brief
Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026 teaser
February 2, 2026

Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026

The ColLABorative Brief
New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back teaser
February 3, 2026

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back

The ColLABorative Brief
DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025 teaser
February 2, 2026

DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

The ColLABorative Brief
Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026 teaser
February 2, 2026

Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026

The ColLABorative Brief
Search Bars, Chatbots, and Tracking Pixels: Practical Steps Labs Can Take to Reduce CIPA Risk in 2026 teaser
February 2, 2026

Search Bars, Chatbots, and Tracking Pixels: Practical Steps Labs Can Take to Reduce CIPA Risk in 2026

The ColLABorative Brief
Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals teaser
February 2, 2026

Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

The ColLABorative Brief
South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks teaser
January 12, 2026

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks

Health Law Diagnosis
OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07 teaser
November 17, 2025

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07

The ColLABorative Brief
Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case teaser
November 17, 2025

Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

The ColLABorative Brief
From Risk to Readiness: Navigating the Payor Audit Landscape teaser
November 17, 2025

From Risk to Readiness: Navigating the Payor Audit Landscape

The ColLABorative Brief
Search Bars, Chatbots, and Tracking Pixels: Practical Steps Labs Can Take to Reduce CIPA Risk in 2026 teaser
February 2, 2026

Search Bars, Chatbots, and Tracking Pixels: Practical Steps Labs Can Take to Reduce CIPA Risk in 2026

The ColLABorative Brief
Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals teaser
February 2, 2026

Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

The ColLABorative Brief
South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks teaser
January 12, 2026

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks

Health Law Diagnosis
OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07 teaser
November 17, 2025

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07

The ColLABorative Brief
Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case teaser
November 17, 2025

Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

The ColLABorative Brief
From Risk to Readiness: Navigating the Payor Audit Landscape teaser
November 17, 2025

From Risk to Readiness: Navigating the Payor Audit Landscape

The ColLABorative Brief

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
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

Events

Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

May 14 2026
Q1 Productions’ 33rd Tri-Annual Diagnostic Coverage & Reimbursement Conference
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

Redefining Audit Preparedness & Compliance for Future-Proof Payments

May 14 2026
Q1 Productions’ 33rd Tri-Annual Diagnostic Coverage & Reimbursement Conference
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

Lab Compliance and Test Utilization: Prepare for 2026 and Beyond

Mar 25 2026
Whitehat Communications’ Point of Care Group Webinar Series
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

Mar 18 2026
Q1 Productions’ 32nd Tri-Annual Diagnostic Coverage & Reimbursement Conference
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

Dec 9 2025
Q1 Productions’ Tri-Annual Diagnostic Coverage & Reimbursement Conference
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

Lab Compliance and Test Utilization: Prepare for 2026 and Beyond

Mar 25 2026
Whitehat Communications’ Point of Care Group Webinar Series
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

Mar 18 2026
Q1 Productions’ 32nd Tri-Annual Diagnostic Coverage & Reimbursement Conference
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

Dec 9 2025
Q1 Productions’ Tri-Annual Diagnostic Coverage & Reimbursement Conference

The ColLABorative Brief

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back

After uncertainty over the last few months, the last few weeks saw potential changes to the Protecting Access to Medicare Act of 2014 (PAMA) under section 6226 of the Consolidated Appropriations Act of 2026. On January 20, 2026, the House Appropriations Committee released the Consolidated Appropriations Act 2026, which included several healthcare extenders, among them revisions to the upcoming PAMA rate cuts and reporting deadlines. The Senate passed the bill on January 30, 2026, and went back to the House on February 3, 2026, at which point it has been set for President Trump’s signature.   First, there are no additional Clinical Laboratory Fee Schedule (CLFS) rate cuts scheduled for 2026.  The act then extends the phase-in of the rate reductions for an additional year, delaying this until 2027, 2028, and 2029. The act also updates the data collection period to use 2025 rather than 2019 data, and shifts the reporting period to May 1, 2026, through July 31, 2026.  While there is still possibility around the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act (RESULTS) which was introduced in September 2025, it has not yet passed. As such, laboratories must prepare for PAMA with the changes implemented by the passage of the Continuing Resolution. PAMA requires independent, hospital outreach, and physician office laboratories to report private payor rate information and volumes every three years (or annually for Advance Diagnostic Laboratory Tests). CMS used this data to calculate rates under the Clinical Laboratory Fee Schedule (CLFS) to align Medicare payment with commercial market rates by developing a weighted median of the reported private payor rates. Due to underreporting (less than one percent of all laboratories reported data) and underrepresentation of key segments such as hospital outreach and physician office labs, the initial reporting cycle resulted in steeper payment cuts between 2018 and 2020 for laboratories than anticipated. Current rates are based on 2016 data that was reported in 2017. Congress has postponed reporting six times, and with the passage of the CR, the next reporting cycle will be May 1, 2026, through July 31, 2026, resetting the time period for applicable data and relieving labs from the burden (or near impossibility) of reporting 2019 data. What you need to know about PAMA Who must report? “Applicable laboratories” must report private payor rates to CMS. Applicable laboratory means a laboratory under 42 C.F.R. § 493.2 (the Clinical Laboratory Improvement Amendments definition of a laboratory) that: Bills Medicare Part B under its own NPI or for hospital outreach laboratories, bills Medicare Part B on the Form CMS-1450 under type of bill (TOB) 14x; Meets the “majority of Medicare revenue” threshold in a data collection period. Meaning that the laboratory receives more than 50% of its Medicare revenue (Parts A, B, & D including any applicable co-pays/deductibles) under the CLFS and/or Medicare Physician Fee Schedule; and Receives at least $12,500 in CLFS revenue during the data collection period. Entities that do not meet the definition of “applicable laboratory” are not permitted to report. Who is a private payor? A private payor includes any of the following: A health insurance issuer as defined in § 2791(b)(2) of the Public Health Service (PHS) Act; A group health plan as defined in § 2791(a)(1) of the PHS Act; A Medicare Advantage Plan under Part C as defined in § 1859(b)(1) of the Social Security Act (SSA); or A Medicaid Managed Care Organization as defined in § 1903(m) of the SSA. What is reported? An applicable laboratory must collect and report “applicable information” received during the data collection period for each laboratory test code subject to the data collection requirements. Applicable information includes: 1) the specific Healthcare Common Procedure Coding System (HCPCS) code for the test; 2) each private payor rate for which final payment has been made during the data collection period; and 3) the associated volume tests performed for each private payor rate. “Zero dollars,” payments that cannot be identified at the HCPCS level (i.e., bundled payments), payments that were under appeal during the data collection period, and tests billed with miscellaneous/NOC code are not to be reported. How to report? CMS has released a list of applicable HCPCS codes that are subject to PAMA’s data reporting and collection requirements. Additionally, CMS has released a spreadsheet template that an applicable laboratory may use to collect and report the applicable information for each test subject to reporting. The spreadsheet includes information on the HCPCS code, payment rate, volume at the payment rate, and NPI. This spreadsheet may be uploaded to the CMS Enterprise Portal. What happens if an applicable laboratory fails to report? If the Secretary determines that an applicable laboratory has failed to report or has made a misrepresentation or omission of reporting information, the Secretary may apply a civil monetary penalty of up to $10,000 per day for each failure to report or each misrepresentation or omission. Beyond civil money penalties, failure to accurately report can negatively impact the weighted median of private payor rates leading to disproportionate CLFS rate cuts. Important Dates Data Reporting Period: May 1 – July 31, 2026 With the reporting period fast approaching, laboratories should determine whether they are an applicable laboratory and begin preparing the required 2025 private payor data carefully. As the reporting period approaches, CMS plans to issue additional fact sheets to assist labs in the data submission. Laboratories may want to consider consulting with knowledgeable legal counsel to ensure compliance and strategy alignment.

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Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. Introduction On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a new report analyzing Medicare Part B (Part B) spending on laboratory tests in 2024. The Protecting Access to Medicare Act of 2014 (PAMA) requires OIG to publish an annual report detailing the top 25 clinical lab tests by expenditure. Each year, OIG evaluates Part B claims data for tests covered under the clinical laboratory fee schedule (CLFS). Below is a breakdown of the key trends highlighted in the 2024 report. Most notably, 2024 showed a significant rise in genetic and infectious Polymerase Chain Reaction (PCR) disease testing.  Overall Part B Spending and Enrollment Part B spending on clinical laboratory tests reached a peak of $7.9 billion in 2021 during the COVID-19 public health emergency, then declined to $7.8 billion by 2023. In a notable shift, spending rose again in 2024, increasing 5% to $8.4 billion, despite there being no changes to the CLFS since 2020. Strikingly, while overall spending increased, the number of Part B enrollees receiving lab tests fell by 15%, dropping from 27.7 million in 2018 to 23.4 million in 2024. According to OIG, this decline may reflect a broader migration of beneficiaries from Medicare Part B to Medicare Advantage (Part C) enrollment. “Genetic” Testing Continues to Rise The OIG report broadly defines “genetic” testing to include: (a) analysis of genetic material to monitor for genetic variations, mutations or other markers associated with disease or hereditary risk; and (b) analysis of genetic material from pathogens for bacteria or viruses. With the industry seeing an increase of PCR testing for infectious disease and detailed genetic antibiotic resistance testing, Medicare spending significantly increased in 2024. Historically, spending on non-genetic tests such as complete blood counts, metabolic panels, lipid panels, and thyroid tests have far exceeded spending on genetic tests relating to conditions such as cancer, fungal infection, and epilepsy. In 2018, genetic testing accounted for 18% of Part B spending on laboratory tests while 82% went to non-genetic tests.  By 2024, that gap had significantly narrowed with 43% of Part B spending on laboratory tests attributed to genetic testing compared to 57% for non-genetic testing. Over just one year (from 2023 to 2024), Part B spending on genetic testing increased by 20% from $3 billion to $3.6 billion. Utilization trends reflect this same shift. In 2018, 2.4 million Part B enrollees received at least one genetic test, out of the seven million total genetic tests performed that year. By 2024, the number of enrollees receiving at least one genetic test increased by 85% to 4.5 million while the total number of genetic tests performed that year increased by 160% to 18 million. In 2024, the average Part B enrollee received four genetic tests at a cost of $794 per enrollee, and 16 non-genetic tests at a cost of $207 per enrollee. In 2024, genetic testing related to infectious disease totaled $1.4 billion, up from $1.2 billion in 2023, and hereditary/disease genetic testing increased from $1.8 billion in 2023 to $2.2 billion in 2024. In 2024, a total of 346 laboratories received over $1M in reimbursement for “genetic” testing. Among them, 55 received over $10M in reimbursement for genetic testing. Top 25 Lab Tests So, now ranking at the top of the chart of all tests paid under Part B spending is CPT 87798 for infectious disease. Also ranking in the top 15 is CPT 87481.  The top 25 lab tests accounted for $4.1 billion, nearly 50% of all Part B laboratory spending in 2024. Among these, ten were genetic/PCR infectious disease tests, totaling $1.5 billion in Part B spending, while the remaining 15 were non-genetic tests totaling $2.6 billion in Part B spending. Notably, six of the ten genetic tests in 2024 showed at least a 30% increase in Part B spending compared to 2023. The OIG report focused on the fact that the average amount that Medicare Part B paid per enrollee for “genetic” tests approached $800, a 26% increase since 2023. Some of the largest growth was seen for tests billed under procedure CPT 87798, which reached $443 million in Part B spending, representing a 51% increase between 2023 and 2024. Takeaways The 2024 OIG report provides context for the increase in audits around the primarily used codes for infectious disease testing of 87798 and 87481. It also highlights the fact that genetic and PCR infectious disease testing is reshaping the Medicare Part B laboratory spending landscape. These types of testing, once a small share of the Part B landscape, now accounts for nearly half of all spending and continues to grow at a significant rate year after year. The impact of genetic and PCR infectious disease testing on Part B spending is highlighted by the increase in costs despite the decreased utilization.   Laboratories should recognize that genetic and PCR infectious disease testing has become a central driver of Part B costs which is resulting in a shift of audits and likely enforcement priorities by OIG to ensure that labs performing this type of testing are remaining compliant with all Medicare billing policies.

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Search Bars, Chatbots, and Tracking Pixels: Practical Steps Labs Can Take to Reduce CIPA Risk in 2026

Plaintiffs’ firms are adapting the California Invasion of Privacy Act (CIPA), a 1960s-era wiretapping statute, to modern web technologies such as pixels, chatbots, and session replay tools. For laboratories, the practical problem is not only the legal uncertainty, but also that small website implementation details, including when tags fire, what free-text inputs are captured, and what vendors are allowed to do with the collected data, can drive massive exposure, including class actions and arbitrations. CIPA prohibits the intentional eavesdropping on, or recording of, confidential communications without the consent of all parties. Although the law was drafted for telephone calls and physical recording devices, plaintiffs’ attorneys are using it to challenge modern digital engagement tooling on laboratory websites. In practice, complaints often try to characterize routine patient web interactions as “confidential communications,” then allege that third-party tools captured, or received, those communications without proper consent. The exposure can scale quickly because CIPA provides for statutory damages of up to $5,000 per violation and each alleged interception can be pleaded as a separate violation. Major diagnostic laboratories have been targeted by class actions alleging that third-party tracking pixels “intercept” patient communications without consent. Plaintiffs are increasingly alleging that routine web tracking tools, including cookies and IP tracking beacons, function as illegal “pen registers” or “trap and trace” devices. The practical effect is that plaintiffs focus on routing data such as IP addresses and device IDs, not just substantive content. However, courts are divided. Some courts have rejected the theory that routine analytics function as criminal pen registers, while others have allowed the plaintiffs to overcome a motion to dismiss. Even with some favorable decisions, there is still a split amongst jurisdictions that creates uncertainty. Additionally, there is a big increase in claims focusing on on-site search bar functionality. The allegation is that a user’s test inquiry, for example “HIV test” or “cancer screening,” is a confidential communication and that trackers share it with third parties. Further, there is another trend in these CIPA allegations that, as laboratories adopt AI chats for service and navigation, plaintiffs are filing claims alleging that AI systems “listen” to or repurpose patient inputs without consent. Although CIPA is a California statute, plaintiffs are filing against laboratories with limited California connections beyond having websites accessible to California residents. To combat these claims—and avoid them entirely—laboratories should consider adding robust consent banners with true pre-consent blocking of tracking technologies (especially for California-based IP addresses). Additionally, laboratories can update website privacy policy disclosures to clearly describe what is being tracked, why it is collected, and which third parties receive it. In these cases, plaintiffs often quote privacy language against defendants. Misalignment between disclosures and tag behavior creates unnecessary risk. For now, we’ll continue to track plaintiffs’ investment in pen register and trap-and-trace theories, focus on search terms in URLs, and expanded scrutiny of AI chat deployments. We’ll also continue to watch whether legislative activity reemerges after the failure of California’s SB 690 in 2025, but it is unlikely that any relief will take effect until at least 2027. In the meantime, laboratories can reduce CIPA exposure by treating web data flows as a compliance issue, not just a marketing or IT function. A practical 2026 playbook is to inventory every tag and vendor on patient-facing pages, minimize or disable collection of free-text inputs and search terms, confirm that chat tools are configured to avoid sharing or retaining sensitive content, and implement consent that actually controls when third-party technologies load. Aligning real-world site behavior with privacy disclosures, and documenting those controls through periodic technical testing, will put laboratories in the best position to prevent claims and, if you receive a complaint, to quickly demonstrate that no “confidential communications” were intercepted without consent as these theories continue to evolve.

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Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026

The Eliminating Kickbacks in Recovery Act (EKRA), enacted in 2018 as part of the SUPPORT Act, established a criminal statute prohibiting payments for patient referrals related to recovery homes, clinical treatment facilities, and laboratories. EKRA mostly mirrors the Anti-Kickback Statute (AKS) but extends its reach to commercial health insurance as well as federal programs like Medicare and Medicaid. Despite limited regulations and slow enforcement, some guidance emerged in 2025, though significant questions remain unresolved. National Fraud Takedown and EKRA EKRA drew some attention but generally remained a secondary focus. That changed in 2025, when an increase in allegations and indictments for EKRA violations occurred. During the 2025 National Fraud Takedown, several cases involved alleged breaches of both EKRA and the AKS. Kimberly Mable Sims, owner of a laboratory company, Francine Sims Super, office manager at a substance abuse treatment facility in North Carolina, and Keke Komeko Johnson, the Compliance Officer, were all indicted. In addition to accusations about gift cards, it was claimed that the substance abuse clinic routinely sent orders to Sims’s lab, which then performed urine drug tests on its patients and billed Medicaid. Allegedly, employees at the treatment center received kickbacks from the lab, while profits from referred specimens were equally split among the office manager, lab owner, and a biller. Earlier in 2025, Sims admitted guilt for EKRA violations. On August 25, 2025, Johnson and Super also pleaded guilty to paying kickbacks, resulting in a six-year sentence for Super. Ninth Circuit Clarifies EKRA In July 2025, in United States v. Schena, No. 23-2989 (9th Cir. July 11, 2025), the Court of Appeals for the Ninth Circuit upheld Mark Schena’s conviction for violating EKRA. Schena, who owned a laboratory, had paid marketing intermediaries to encourage referrals for questionable allergy tests. During the original trial, there was disagreement between Schena and the Department of Justice (DOJ) over how EKRA should be interpreted, particularly regarding whether the district court had correctly applied EKRA in S&G Labs Hawaii, LLC v. Graves, No. 1:2019cv00310 (D. Haw. 2021), aff’d, No. 24-823 (9th Cir. Jul 11, 2025) (unpublished). The Ninth Circuit panel considered two main issues: (1) whether marketing intermediaries were covered by 18 USC § 220(a)(2)(A); and (2) if payments to these intermediaries constituted “inducement” under EKRA. The court concluded that marketing intermediaries who interact with ordering providers can fall under EKRA, further clarifying that payments do not have to go directly to the provider to violate EKRA. Finally, the court addressed the confusion created by the district court’s  interpretation of EKRA was incorrect in S&G Labs Hawaii and realigned the Ninth Circuit’s reading of EKRA with other circuits’ approaches to the AKS. Regarding what “to induce” a referral means, the Ninth Circuit found that simply paying percentage-based compensation is not automatically a violation of EKRA. There must be intent to improperly influence providers’ referrals through false or fraudulent means. However, the court did not define exactly which situations would show wrongful attempts to sway medical professionals’ decisions. The case isn’t finished yet. Mark Schena has asked the United States Supreme Court to determine whether paying healthcare marketers a commission counts as “remuneration...to induce a referral” under EKRA. The Supreme Court has not yet decided whether it will hear the case. Other Notable EKRA cases A relator brought a False Claims Act case against a laboratory consortium of four interrelated companies (one investment firm and three executive), but the government declined to intervene.  The relator has proceeded with the case, and the amended complaint alleges violations of the False Claims Act based, in part, on violations of EKRA and the AKS. It is alleged that the laboratory consortium paid sales representatives based on the volume and profitability of laboratory testing specimens based on a percentage of its reimbursement.  The laboratory consortium argued: [U]nder Fifth Circuit precedent, Thompson’s allegations that defendants paid sales representatives volume- and profitability-based commissions is insufficient to plead a violation of the AKS and the EKRA, and Thompson must allege instead that the sales representatives improperly influenced the clinicians who sent samples to Apollo Labs and Arbor, such as by paying them a kickback or substituting their own judgment for that of the clinician. U.S. ex. rel Thompson v. Apollo Path LLC, No. 3:20-cv-02917, Dkt. 77, at 8 (N.D. Tex. Mar. 5, 2025). The court agreed, relying on U.S. v. Marchetti¸ 96 F.4th 818(5th Cir. 2024), and stated: In sum, a defendant’s payments to a third party to procure referrals from clinicians are made with the intent “to induce referrals” within the meaning of the AKS and the EKRA when there is evidence that the defendant intended for the third party to improperly influence the clinicians. Examples of improper influence include exploiting personal access and making the final decision about patient care. Id. at 14. In April 2025, the Court dismissed both the federal and state law claims. Id., Dkt. 94 (Apr. 30, 2025). Throughout 2025, there have been several indictments involving EKRA that have not necessarily involved laboratories but have been focused on substance abuse facilities, brokers, and marketing for sober homes and substance abuse facilities. A number of these actions are focused on California. See, e.g., United States v. Patton, No. 2:25-cr-00489 (C.D. Cal. June 17, 2025) (owner of a marketing company was indicted for allegedly referring patients with commercial health insurance to substance abuse treatment facilities); United States v. Mahoney, No. 8:21-cr-00183 (C.D. Cal. Mar. 21, 2025) (owner of addiction treatment facility sentenced to 41 months for violating EKRA) (appeal filed Mar. 2025); United States v. Simons, No. 3:25-cr-02444 (S.D. Cal. June 18, 2025) (CEO of multiple substance use disorder treatment facilities and sober homes was indicted for allegedly paying entities for marketing services).  Each of these focus on payment that varies based on referral quotas, a lesson that can be instructive for clinical laboratories navigating EKRA too.  Conclusion These recent developments in EKRA enforcement and judicial interpretation highlight the statute’s evolving scope and its increasing impact on laboratories, substance abuse facilities, and associated marketing practices. New Jersey expanded its patient brokering act to revise the law to specifically address substance user disorder treatment facilities and clinical laboratories. (Approved P.L. 2025, c.121). The Ninth Circuit clarified that EKRA can apply to payments made to sales representatives and that intent plays a critical role in determining whether such payments constitute improper inducement. However, Schena applied for certiorari at the Supreme Court. Texas dismissed a False Claims Act focusing on the lack of allegations regarding improper influence. Ultimately, the trajectory of recent cases signals that both regulators and courts are committed to upholding the integrity of clinical decision-making and preventing undue influence through financial incentives.

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DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. The final quarter of 2025 saw continued enforcement actions against clinical labs and other related healthcare entities. The Office of Inspector General (OIG) and Department of Justice (DOJ) heavily focused on False Claims Act (FCA) violations, Anti-Kickback Statute (AKS) violations, conspiracies, and COVID-19 related fraud. Below are highlights of these enforcement actions. Across Q4 2025, federal enforcement actions against clinical laboratories and related entities reflected consistent patterns of fraudulent genetic testing schemes, kickback arrangements, telemarketing‑driven referrals, and billing misconduct. Many cases involved medically unnecessary cancer genetic (CGx) and respiratory pathogen panel (RPP) testing, often ordered without patient contact, physician-patient relationships or proper clinical oversight. Enforcement also targeted laboratories that concealed ownership, shifted billing to evade scrutiny, or paid marketers, recruiters, and physicians to induce referrals. The DOJ and OIG continued to pursue individuals and entities that exploited Medicare beneficiaries—particularly older adults—through telemarketing campaigns, data harvesting, and fraudulent COVID‑19 test claims. Collectively, these actions underscore the government’s intensified focus on schemes that capitalize on vulnerable patient populations and exploit gaps in laboratory oversight. Enforcement agencies are also scrutinizing financial arrangements that mask kickbacks—whether framed as consulting fees, MSAs, or commission‑based compensation—as well as billing practices designed to maximize reimbursement through unbundling or duplicative claims Case Highlights On October 23, 2025, a New York doctor was sentenced to seven years in prison for participating in a scheme where he ordered CGx and other laboratory tests despite never treating, speaking to, or examining the patients in exchange for kickbacks. Specifically, he ordered CGx testing on Medicare beneficiaries who attended COVID-19 testing events at assisted living facilities, adult day care centers and retirement communities. On October 23, 2025, a lab owner that operated several laboratories out of Louisiana and Texas was sentenced to ten years in prison for orchestrating a scheme in which he conspired with telemarketers and call centers who implemented aggressive campaigns to induce beneficiaries to receive CGx and cardiovascular genetic testing. The orders were then signed by purported telehealth physicians who did not consult with, treat, or follow up with the beneficiaries receiving the testing. The owner also shifted billing between laboratories to evade scrutiny from Medicare and concealed ownership and control of the laboratories. On October 29, 2025, a clinical laboratory self-disclosed conduct and agreed to pay $85,000 for allegedly employing an excluded individual in violation of the Civil Monetary Penalties Law. On November 13, 2025, the owners of a telemarketing company were sentenced for their roles in a CGx testing fraud scheme where they targeted and steered Medicare beneficiaries to labs where they would receive medically unnecessary testing. Additionally, during a pending criminal case for genetic testing fraud, one of the owners opened a clinical laboratory and disguised his ownership of the laboratory. On November 17, 2025, an urgent care clinic agreed to pay $2.8 million to settle claims that they allegedly “unbundled” respiratory and urinary tract infection panel tests and billed for each individual component separately resulting in overbilling to federal health care programs. On November 20, 2025, the owner of two clinical laboratories pleaded guilty to one count of wire fraud for a scheme in which he paid his co-conspirators kickbacks to obtain the Medicare numbers and identifiers of patients without their consent. The lab owner then used the information to submit Medicare claims for COVID-19 test kits which were sent to patients who had not requested them. The owner also persisted after patients called stating that they had not requested the test kits. On November 20, 2025, a diagnostic laboratory agreed to pay $1.635 million to resolve allegations that the lab submitted claims for RPPs which were obtained through kickbacks or were medically unnecessary in violation of the FCA and AKS. More specifically, the government alleged that the lab entered into a Marketing Services Agreement (MSA) in which they paid a purported infection prevention company between $4,000 and $4,500 per facility per month for marketing and management services when, in reality, the MSA was a way to cover-up payments for laboratory referrals. Further, the laboratory allegedly combined RPPs with COVID-19 tests when facilities were only seeking COVID-19 tests. On November 24, 2025, it was announced that a diagnostic laboratory agreed to pay over $9.6 million to resolve allegations that it violated the FCA and AKS by submitting claims for RPPs that were medically unnecessary or obtained through kickbacks and by paying commissions to sales and marketing representatives based on volume or value of lab referrals which were later billed to Medicare. On December 2, 2025, a Georgia man was sentenced to 46 months in prison and ordered to pay $7.2 million in restitution for engaging in a scheme where he instructed recruiters to convince Medicare beneficiaries to accept medically unnecessary genetic testing. As part of the scheme, he created sham invoices documenting fabricated numbers of hours worked instead of the per-referral payments he received. As a result of the scheme, the man received $4.3 million in kickbacks and bribes. On December 2, 2025, a man was sentenced to two years in prison for his role in a conspiracy to bill Medicare for COVID-19 tests and RPPs which were never ordered or performed. On December 4, 2025, a clinical laboratory agreed to pay $758,000, plus additional amounts if certain financial contingencies occur, to resolve allegations that they violated the FCA and AKS by paying doctors and marketers illegal kickbacks which were disguised as consulting and medical director fees to induce laboratory testing referrals. In addition, the lab was also alleged to have paid independent contractors marketers’ commissions based on volume and value of referrals. This settlement also resolved an underlying lawsuit raised under the qui tam provision of the false claims act. On December 5, 2025, two Illinois men were indicted in a superseding indictment for their alleged role in a scheme to defraud federal and private health insurers by submitting fraudulent claims for COVID-19 laboratory testing services which were never provided and for participating in a conspiracy to launder the fraudulent proceeds by transferring the funds between laboratories and other businesses under their control. Takeaways Clinical labs should take these enforcement actions as warnings. First, conduct internal audits of referral relationships to ensure compliance with the AKS, as kickbacks remain a top enforcement priority and continue to monitor the arrangements in practice. Second, strengthen billing oversight and implement internal controls to avoid FCA exposure, which continues to drive multimillion-dollar settlements. Third, screen employees and contractors against exclusion lists to avoid potential violations of the CMP law. Finally, stay alert to evolving enforcement trends, including scrutiny of genetic testing, telemarketing arrangements, and lingering COVID-related fraud. Proactive compliance is essential for mitigating risk. The Q4 enforcement trends send a clear message that laboratory enforcement remains a top priority at the federal level. Now is the time for laboratories to review their compliance programs, oversight and monitoring practices and close any potential gaps.

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OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07

This post is co-authored with Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free, FDA-approved companion diagnostic test for eligible patients would not implicate the Federal Anti-Kickback Statute (AKS) or the Beneficiary Inducements civil monetary penalties (CMP). Background The requestor (a pharmaceutical manufacturer) produces an FDA-approved enzyme inhibitor. Treatment with the inhibitor is only appropriate with specific genetic deficiencies. A clinical laboratory developed an FDA-approved companion diagnostic test which is required to determine patient eligibility for the inhibitor. The two wished to work together. The Arrangement Under the parties’ proposed arrangement, the requestor pays the lab a fixed fee for each test performed on an eligible patient, and prohibits the lab from billing any patients, or payors other than the requestor for the testing. The test is offered to patients who: (i) have a prior negative result for a related genetic mutation; (ii) have previously collected tumor samples available for testing; (iii) have not previously received the test; and, in addition, (iv) the test must be used in accordance with FDA labeling. According to the requestor, this arrangement is designed to better identify patients whose deficiency has gone undetected and to determine whether use of the inhibitor would be appropriate. The requestor certified that the lab is contractually prohibited from: (i) referencing any of the lab’s other products on their “provider facing webpage;” (ii) promoting any of the lab’s or requestor’s other products in any “lab developed communications” to ordering providers or patients; and (iii) communicating with patients regarding the Arrangement unless required by law.  Additionally, the requestor certified that it would only receive “limited aggregated de-identified date” relating to the test through monthly reports. According to the requestor the reports would include: (i) the number of tests performed under the arrangement; (ii) the cumulative results of all tests performed under the arrangement, and (iii) digital awareness results including the source and number of visits to the the parties’ dedicated website and the clicks on the QR code in pamphlets that were left behind at the provider’s office . The requestor further certified that this data will only be used to: (i) better understand the number of patients with the condition which was missed by  standard testing; (ii)verify the amount invoiced the requestor; and (iii) ensure that the parties’ arrangement is “being conducted in accordance with the terms of the agreement between the lab and the requestor.” OIG Analysis Anti-Kickback Statute The OIG acknowledged that the arrangement could implicate the AKS by offering remuneration (i.e., the free test) that may induce referrals for federally reimbursable items or services and the safe harbor would not apply in this situation. However, OIG concluded that it would not impose sanctions for several reasons: The arrangement presents little risk of overutilization or skewing clinical decision making. The test determines whether the inhibitor would be an appropriate method of treatment for patients and would only be appropriate for patients presenting with the deficiency. The test may also show the drug is not indicated in approximately half the cases. Providers do not receive any remuneration from the requestor for prescribing the drug. Additionally, the requestor’s field personnel are prohibited from discussing the drug in relation to the arrangement. The requestor will only receive de-identified data which it certifies will not be used for sales or marketing purposes including sales targeting or incentives. The agreement prohibits the lab from promoting the arrangement to patients and providers and the requestor certified that it will not provide information about the arrangement to patients or providers directly. There are various safeguards in place to prevent this being used as a marketing or sales tool to steer providers to order any items or services from requestor or the lab, including the drug. Beneficiary Inducements CMP OIG also concluded that the parties’ arrangement does not violate the Beneficiary Inducements CMP. Although providing a free test constitutes remuneration, OIG found that the arrangement meets the statutory exception for promoting access to care with a low risk of harm. Specifically, the arrangement: May improve a beneficiary’s ability “to obtain items and services payable by Medicare or Medicaid” in instances when the inhibitor is covered by those programs. Is unlikely to interfere with clinical decision making because the test only confirms whether the inhibitor can be prescribed for a particular patient which a provider may already be considering. Does not raise quality of care or patient safety concerns because it is used to determine whether the inhibitor would be an effective treatment for a specific patient. Is unlikely to increase costs to federal health care programs because the inhibitor may be a life-extending treatment that is already under consideration by the provider. Additionally, the test will determine the appropriateness of prescribing the inhibitor and nearly 50% of patients will be ineligible for the inhibitor after testing. Finally, the arrangement does not incentivize providers to prescribe the inhibitor in any way. As is standard, OIG cautioned that its advisory opinion is limited to the proposed arrangement only and does not cover any other arrangements. OIG further cautioned that the opinion does not provide any opinion on liability in relation to the False Claims Act and, finally, that the opinion is only binding on the Department of Health and Human Services but no other government agencies. Takeaways The advisory opinion provides valuable insight into how OIG evaluates pharmaceutical manufacturer sponsored diagnostic testing programs under the AKS and CMP. By imposing certain structural safeguards including clear eligibility criteria, de-identified data sharing, and marketing restrictions manufacturers may be able to establish programs that increase access to care without implicating the AKS or CMP. The advisory opinion may provide a potential model for other labs and pharmaceutical manufacturers to enter into agreements where the manufacturer would sponsor companion laboratory tests. We will continue to monitor for additional guidance that OIG may issue on this and related topics.

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

This was was authored by Edward J. Heath, co-chair of Robinson+Cole’s Enforcement, Investigations + Litigation in Health Care team. Since January, there have been almost daily media reports about federal government agents conducting operations intended to sweep up individuals who are in the U.S. illegally. The primary agency responsible for these activities is Immigration and Customs Enforcement (ICE). “ICE raids,” as they have come to be called, have caused a great deal of confusion and anxiety for health care entities, including clinical laboratories, who struggle to balance cooperation with law enforcement on the one hand, and respecting the right of their employees and patients on the other. Historically, the concept of a law enforcement “raid” has arisen in the context of search warrants. Search warrants are judge-signed orders that allow agents to enter a particularly designated place to search for and seize a particularly identified thing or things. In the prototypical example of a search warrant raid, multiple dark vans or SUVs pull up in front of the laboratory site, numerous agents in bulletproof vests and jackets emblazoned with “FBI” pour out of those vehicles and rush into the building, causing panic as they charge into offices and storage rooms, grabbing technology and paper. If federal agents appear with a valid warrant, laboratory personnel cannot physically stand in their way. Any obstruction is likely to result in criminal charges.   As a result of policy changes by the new presidential administration, however, the “raid” concept that now comes to mind are “ICE raids.” ICE was created in 2003 in a merging of the investigative and interior enforcement elements of the former U.S. Customs Service and the Immigration and Naturalization Services.  ICE is now a division of the U.S. Department of Homeland Security, and it has a budget of approximately $8 billion and workforce of roughly 20,000 personnel. Its scope of operations includes enforcement of the laws governing immigration, border control, customs, and trade. ICE Within ICE, the unit or “directorate” responsible for the recent “raids” is known as Enforcement and Removal Operations. It is important to understand that ICE agents are essentially federal police officers. They are not the military operating unrestricted in a war zone. Like FBI agents, their powers are limited by the U.S. Constitution and federal law more generally. ICE agents usually appear with an administrative warrant signed by an immigration judge; these warrants do not grant agents the broad powers of a search warrant. Absent a valid search warrant signed by a United States District Court judge, ICE agents appearing with an administrative warrant or subpoena still generally need the consent of the laboratory to enter into private places to search for and take documents or property—or to seize individual persons. This raises some key questions about circumstances where there is no search warrant involved: Do we have to let them come into our facilities?  ICE agents have the right to enter into any part of a lab’s facility, like a waiting room, that is open to the general public. ICE agents are not, however, authorized to enter into any non-public areas within the facility without permission. Importantly, permission to enter private areas can be expressly given or even implied from circumstances, so it is important that lab personnel understand clearly which areas of the facility are public and which are private. It is critical that personnel know precisely what to say to explicitly decline an ICE agent’s demand to access a non-public area.   Do we have to answer their questions?  Although ICE agents are free to ask questions about the lab’s operations, employees, and patients, there is no obligation to answer those questions. Additionally, protected health information (PHI) is protected from disclosure under HIPAA and a number of state laws, just as is personnel information about any of the lab’s employees. Again, it is important that personnel have been instructed how to respectfully decline to answer questions from agents. Do we have to show them records or give them copies?  As with questions seeking information, there is no obligation to produce documents for ICE’s review or seizure. Moreover, documentation with PHI and personnel information should not be made available to government agents without a subpoena or search warrant. Beyond that, when agents on are site, employees should take care not to have electronic or paper document in plain sight where they may be viewed by agents. Should we physically stop ICE agents who are attempting, without our consent, to enter into a private area in the lab or to take documents or property?  No.  Any physical interference, particularly physical contact, with an ICE agent is likely to be met with an arrest and ensuing federal criminal charges. The appearance of federal agents will be a stressful situation for almost all lab personnel. The stakes are high, so it is important to seek guidance from legal counsel in these situations.  Nonetheless, it is also worthwhile to consider working with legal counsel to develop in advance a straightforward written policy for employees to reference at the moment ICE arrives on site.  Such a policy would be designed to minimize anxiety while ensuring legally appropriate outcomes.

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Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

This post is co-authored by Julianna M. Charpentier, a member of Robinson+Cole’s Enforcement, Investigations + Litigation in Health Care team. Earlier this year, a Florida jury fully acquitted two owners of an independent clinical laboratory located in San Antonio, Texas accused of conspiring to commit health care fraud and wire fraud. Defendants Diego Sanchez Chocron and Gregory “Milo” Caskey were charged alongside their laboratory co-owner Enrique Perez-Paris and two patient recruiters to whom they were accused of paying kickbacks. The Department of Justice alleged that Sanchez Chocron, Caskey, and Perez-Paris conspired to falsely bill Medicare and the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program $44 million for COVID-19 and genetic testing during the COVID-19 pandemic. Prosecutors alleged that the laboratory owner defendants paid kickbacks, that the tests were medically unnecessary, and that the defendants billed for tests not approved by the US Food and Drug Administration (FDA) for emergency-use authorization. Perez-Paris (and the two alleged kickback recipients) pleaded guilty to conspiracy to commit health care fraud in the weeks leading up to the trial and he testified against his former partners. Perez-Paris pleaded guilty in February 2025 to one count of the superseding indictment that he “knowingly and willfully combined, conspired, confederated, and agreed with others, in violation of Title 18, United States Code, Section 1349, to commit health care fraud....including Medicare and the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment and Vaccine Administration for the Uninsured Program (“HRSA COVID-19 Uninsured Program”).” Unlike Perez-Paris, Sanchez Chocron and Caskey proceeded to trial. While their acquittals may be relatively rare, particularly in light of their alleged co-conspirator’s guilty plea and testimony, the jury’s verdict was foreshadowed by a pair of rulings from the bench. First, Judge Rodolfo A. Ruiz II granted in part the two defendants’ motion to strike certain portions of the superseding indictment, agreeing with the defendants that HRSA did not incorporate Medicare coverage rules requiring provider authorization for a COVID-19 test, and holding that “the Government may not argue that a failure to procure authorization from a healthcare provider for a COVID-19 test automatically constitutes a violation of the HRSA Terms and Conditions.”  Judge Ruiz further held that “failure to procure authorization from a healthcare provider for a COVID-19 test under the HRSA Terms and Conditions does not automatically establish a violation of the criminal statutes set forth in the Superseding Indictment.” Judge Ruiz was careful to note that the government could use the fact that tests were not ordered by a healthcare provider as evidence of defendants’ knowledge and intent, as well as in connection with the materiality of defendants’ alleged representations to the HRSA uninsured program. Second, Judge Ruiz also granted the defendants’ motion for acquittal on charges that they conspired to pay kickbacks and commit money laundering.   The jury appears to have agreed with the arguments made by defense counsel who argued that the evidence presented established their clients’ good faith beliefs that their actions were legal, and that the tests were not medically unnecessary, as demonstrated by the defendants’ actions in consulting with counsel and other experts.  The full acquittal of Sanchez Chocron and Caskey underscores the importance of the intent elements of the Anti-Kickback Statute and other fraud statutes.  Despite the government’s reliance on co-defendant testimony and allegations of widespread misconduct, the jury found the evidence insufficient to convict. Key rulings by Judge Rodolfo A. Ruiz II—particularly those limiting the government’s interpretation of HRSA requirements and dismissing kickback and money laundering charges—significantly shaped the trial’s trajectory. Ultimately, the verdict affirms that, even in high-stakes federal prosecutions, defendants who act in good faith and seek appropriate legal guidance can prevail when they have the facts and the law on their side.

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From Risk to Readiness: Navigating the Payor Audit Landscape

As payer audits become more frequent and complex, laboratories and healthcare providers must be equipped to respond effectively. Labs are especially vulnerable due to high-cost services and billing complexity. Triggers include but are not limited to sudden spikes in service volume, changes in test panels or clientele, use of uncommon codes or modifiers, and high denial rates or billing patterns that differ from peers. Being proactive is the most effective way to manage audit risk. Laboratories should begin by implementing regular internal audits to identify and correct documentation or billing issues before they escalate. Monitoring the Medicare Administrative Contractors (MACs) audit lists is also essential, as these lists highlight services that may be targeted for review. Every year, a report is issued that reflects the total Medicare Part B spending on lab tests.  Earlier this summer, the OIG added to its work plan a review of “Medicare Payments for Clinical Diagnostic Tests in 2024” to analyze the top 25 laboratory tests by expenditures which is expected to be released in 2026. The report issued at the end of 2024 for the review of 2023, showed an overall decrease of spending on clinical diagnostic laboratory testing but reflected a steady increase on genetic tests.  Genetic testing spending has risen to $1.8 billion, a 32% increase from 2022 to 2023.  These reports and the focus on the top 25 tests provide insight to laboratories as to which tests may be more scrutinized for utilization. While laboratories can rely on the ordering provider’s determination of medical necessity, laboratories still play a role in ensuring medical necessity.  As such, laboratories and providers must collaborate to ensure that documentation is thorough and consistent. Laboratories may want to verify that all claims include clear medical necessity documentation. Enhancing requisition forms can help ensure that all necessary information is captured upfront, reducing the likelihood of denials. Staying informed is equally important. Laboratories should routinely review and stay up to date on payor policies, which can change frequently and vary between Medicare, Medicaid, and private insurers. When an audit occurs, laboratories should prepare all requested documentation carefully and include any supplemental materials that support the claim. It is important to review everything before submission, communicate early and often with auditors, and request extensions if needed. Laboratories may want to consider consulting with knowledgeable legal counsel to ensure compliance and strategy alignment.

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Robinson+Cole has expanded its firmwide artificial intelligence (AI) capabilities by integrating Thomson Reuters’ Deep Research directly into Newcode.ai, the agentic AI platform implemented last year by the firm to support legal workflows across practices. With this integration, Robinson+Cole is one of only two law firms with direct access to the Deep Research API—and the only firm deploying it through Newcode.ai. Building on its 2025 partnership with Newcode.ai —making Robinson+Cole the first Am Law 200 firm to adopt the platform—the firm has continued to expand its AI capabilities as part of a broader strategy focused on secure deployment, ethical use, and seamless integration into daily legal work. The integration enables Robinson+Cole attorneys to conduct complex, multi‑step legal research and receive verifiable, citation‑backed responses grounded in trusted Thomson Reuters content. By embedding Deep Research into Newcode.ai, Robinson+Cole continues to build on its deliberate, governance‑first approach to AI adoption while delivering meaningful, practice‑ready innovation for its lawyers and clients. “Innovation at Robinson+Cole is grounded in client service, security, and practicality,” said J. Michael Wirvin, Managing Partner of Robinson+Cole. “By incorporating Thomson Reuters’ Deep Research directly into Newcode.ai, we are providing our lawyers with advanced research capabilities in a secure environment fully controlled by the firm that aligns with our standards for data governance, accuracy, and responsible AI use. This integration reflects our continued focus on adopting technology thoughtfully to support our attorneys and deliver value to our clients.” The addition of Deep Research allows attorneys to: Perform sophisticated legal research using agentic workflows that mirror real‑world legal reasoning Receive structured, verifiable responses grounded in Thomson Reuters data Streamline research processes while maintaining rigorous quality and accuracy standards Work entirely within Robinson+Cole’s firm‑controlled AI environment  “Our integration of the Thomson Reuters’ Deep Research API with Newcode represents a defining moment in our AI strategy,” said Chief Data Officer Jim Merrifield. "We are incredibly proud to be the first firm to bring this capability to life—unlocking the power of trusted legal data directly within the workflows our lawyers and business professionals rely on every day. This is exactly how we maximize our technology investments: by connecting best-in-class data sources through APIs into a unified platform, so the technology meets our people where they work, enhances their judgment, and accelerates better outcomes for our clients.” Robinson+Cole’s AI program is guided by firmwide policies, mandatory training, and ongoing oversight to ensure responsible use of emerging technologies. The firm’s approach emphasizes measured adoption, strong information governance, and alignment with client expectations, rather than one‑off experimentation. This latest enhancement underscores Robinson+Cole’s commitment to remaining forward‑thinking in its use of technology, while ensuring that innovation serves the firm’s clients, lawyers, and long‑term strategic goals.

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Robinson+Cole Expands National Platform with Four Lateral Partners

Robinson+Cole announced the addition of four lateral partners—J. Zachary Balasko, Eric Del Pozo, Brya M. Keilson and Victor R. Salgado, accelerating the firm’s continued investment in the growth of its national bankruptcy and business litigation capabilities. Balasko and Keilson join the firm’s Bankruptcy + Reorganizations group in Washington, DC, and Wilmington, DE, respectively, while Del Pozo and Salgado join the Business Litigation group in Hartford, CT, and Washington, DC. These strategic hires enhance the firm’s ability to serve clients navigating complex, high‑stakes bankruptcy, restructuring, government enforcement, and related litigation matters nationwide and expand the firm’s depth and reach across key markets. “These additions meaningfully reinforce the depth and versatility of our business litigation and restructuring platform and reflect a deliberate approach to strengthening these areas in ways that directly benefit our clients,” said J. Michael Wirvin, the firm’s Managing Partner. “Eric, Zak, Brya, and Victor each bring sophisticated experience and sound judgment that enhance our ability to advise clients through some of their most critical and challenging matters. Their arrival reflects our continued focus on building cohesive, multi-disciplinary teams with capabilities that extend across multiple markets.” J. Zachary Balasko joins the firm as a Bankruptcy + Reorganizations partner based in Washington, DC. His practice focuses on complex Chapter 11 cases and bankruptcy‑related litigation across the country, representing debtors, secured creditors, creditors’ committees, and governmental entities. Balasko brings substantial experience from both private practice and prior service with the U.S. Department of Justice, where he handled major insolvency matters involving federal interests. Eric Del Pozo joins Robinson+Cole’s Hartford, CT office as a Business Litigation partner focusing on complex commercial litigation and appellate matters, representing businesses and public entities in regulated industries in high-stakes and sophisticated disputes. Del Pozo brings experience from senior roles in government and private practice, where he has represented clients at both the trial and appellate levels. Brya Keilson joins Robinson+Cole as a Bankruptcy + Reorganizations partner in the firm’s Wilmington, DE office, one of the nation’s leading venues for complex bankruptcy proceeding . She represents debtors, creditors, committees, trustees, and other parties in interest in sophisticated Chapter 11 and Chapter 7 cases. Keilson is widely experienced in contested bankruptcy matters and frequently advises clients on both strategic and practical considerations throughout the restructuring process. Victor Salgado joins Robinson+Cole as a Business Litigation partner in the firm’s Washington, DC office. He brings significant experience from both government and private practice, including eight years as a federal prosecutor with the U.S. Department of Justice in Washington, DC, where he handled high‑profile and complex cases focusing on public corruption as well as crimes involving financial institutions. Salgado will also work closely with the firm’s Bankruptcy + Reorganizations group on contested matters arising in complex restructurings and related litigation. In addition, Destiney Parker-Thompson joins the firm as a Bankruptcy + Reorganizations associate in the Wilmington office. Parker‑Thompson focuses her practice on bankruptcy, restructuring, and related litigation matters, drawing on experience representing debtors, creditors, and financial institutions in complex Chapter 11 cases. She previously served as a judicial law clerk to the U.S. Bankruptcy Court for the District of Delaware and the U.S. Court of Appeals for the Third Circuit, bringing valuable insight to sophisticated restructuring matters. Robinson+Cole’s Bankruptcy + Reorganizations group has recently been recognized for its role in several of the most complex and precedent‑setting restructuring matters in the country, earning multiple national honors for its work in high‑profile Chapter 11 cases and related litigation. The group has guided stakeholders through landmark proceedings—including award‑recognized reorganizations, a first‑of‑its‑kind bankruptcy confirmed with a Section 524(g) injunction, and other transformative restructurings—reflecting the team’s ability to deliver strategic, results‑driven counsel in matters with significant legal and financial implications.

News
Kate Dion and Natale DiNatale Examine the Legal Questions Raised By Sorsby Injunction

Education industry team chair Kathleen Dion and Labor Relations group chair Natale DiNatale discussed the potential ramifications on the NCAA and college athletes in the article, “NCAA to appeal Brendan Sorsby injunction. What it means and how it can win,” published in USA Today, June 8, 2026. Kate pointed out that the injunction is a temporary measure. “This decision is only a preliminary ruling and is subject to appeal. Unless it is overturned, the injunction preserves Sorsby’s opportunity to compete this fall while the underlying case proceeds and allows him to continue preparing for a potential NFL career. For the NCAA, the ruling raises questions about the extent to which courts may review and potentially limit the enforcement of eligibility and competitive-integrity rules in individual cases.”  She continued, “It is also important to recognize that this is one state trial court decision, not a final decision on the merits, and thus its precedential value may be limited. While the court found that Sorsby demonstrated a probable right to the relief that he seeks on his breach of contract and other claims, which is a necessary element for obtaining a temporary injunction — the order does not appear to provide a detailed explanation of the court’s reasoning on that issue. As a result, many of the legal questions raised by the case are likely to remain the subject of further litigation and possible appellate review.” Discussing the foundation of the claim, Natale said, “The underlying dispute looks like a claim that the NCAA failed to accommodate a disability (e.g. an ADA claim based on a gambling addiction). But, it was brought as a breach of contract claim. A contract claim can be brought and maybe kept, in state court, which is likely a friendlier forum for this athlete.” Read the article.

News
Julianna Charpentier Recognized as an “Up & Coming Lawyer”
News
Erica Kerstein Brings Credibility and Business Perspective to New Role as Practice Group Chair

Insurance + Reinsurance group chair Erica J. Kerstein was featured in a Law.com column titled, “How I Made Practice Group Chair,” published on April 15, 2026. In the article, Erica discusses her new role as a practice group chair and how it has expanded her insight into not only the firm’s strategic vision and goals, but the reality of running a business and ensuring that current planning aligns with future goals. “The role provides a window into how individual practices fit into the firm’s overall strategy,” said Erica. “You’re thinking not just about today’s matters, but about where clients are headed, how the industry is changing, and how the firm positions itself to meet those needs.” In addition, Erica also identified “…strengthening client relationships, investing in our people, and staying ahead of emerging issues—particularly around technology and artificial intelligence in the insurance space…” as key priorities for the practice. Read the article.

News
Dana Horton Ascends to Presidency of Rhode Island Bar Association
News
Robinson+Cole’s People-First Culture Recognized in Vault’s 2027 Rankings
News
Robinson+Cole Integrates Thomson Reuters’ Deep Research into Newcode.ai Platform to Advance Secure, Verifiable Legal Research

Robinson+Cole has expanded its firmwide artificial intelligence (AI) capabilities by integrating Thomson Reuters’ Deep Research directly into Newcode.ai, the agentic AI platform implemented last year by the firm to support legal workflows across practices. With this integration, Robinson+Cole is one of only two law firms with direct access to the Deep Research API—and the only firm deploying it through Newcode.ai. Building on its 2025 partnership with Newcode.ai —making Robinson+Cole the first Am Law 200 firm to adopt the platform—the firm has continued to expand its AI capabilities as part of a broader strategy focused on secure deployment, ethical use, and seamless integration into daily legal work. The integration enables Robinson+Cole attorneys to conduct complex, multi‑step legal research and receive verifiable, citation‑backed responses grounded in trusted Thomson Reuters content. By embedding Deep Research into Newcode.ai, Robinson+Cole continues to build on its deliberate, governance‑first approach to AI adoption while delivering meaningful, practice‑ready innovation for its lawyers and clients. “Innovation at Robinson+Cole is grounded in client service, security, and practicality,” said J. Michael Wirvin, Managing Partner of Robinson+Cole. “By incorporating Thomson Reuters’ Deep Research directly into Newcode.ai, we are providing our lawyers with advanced research capabilities in a secure environment fully controlled by the firm that aligns with our standards for data governance, accuracy, and responsible AI use. This integration reflects our continued focus on adopting technology thoughtfully to support our attorneys and deliver value to our clients.” The addition of Deep Research allows attorneys to: Perform sophisticated legal research using agentic workflows that mirror real‑world legal reasoning Receive structured, verifiable responses grounded in Thomson Reuters data Streamline research processes while maintaining rigorous quality and accuracy standards Work entirely within Robinson+Cole’s firm‑controlled AI environment  “Our integration of the Thomson Reuters’ Deep Research API with Newcode represents a defining moment in our AI strategy,” said Chief Data Officer Jim Merrifield. "We are incredibly proud to be the first firm to bring this capability to life—unlocking the power of trusted legal data directly within the workflows our lawyers and business professionals rely on every day. This is exactly how we maximize our technology investments: by connecting best-in-class data sources through APIs into a unified platform, so the technology meets our people where they work, enhances their judgment, and accelerates better outcomes for our clients.” Robinson+Cole’s AI program is guided by firmwide policies, mandatory training, and ongoing oversight to ensure responsible use of emerging technologies. The firm’s approach emphasizes measured adoption, strong information governance, and alignment with client expectations, rather than one‑off experimentation. This latest enhancement underscores Robinson+Cole’s commitment to remaining forward‑thinking in its use of technology, while ensuring that innovation serves the firm’s clients, lawyers, and long‑term strategic goals.

News
Robinson+Cole Recognized Across Practices and Regions with 46 Chambers USA 2026 Rankings
News
Robinson+Cole Recognized at 2026 Women, Influence & Power in Law Awards
News
Robinson+Cole Expands Philadelphia Office at Landmark Liberty Place
News
Robinson+Cole Expands National Platform with Four Lateral Partners

Robinson+Cole announced the addition of four lateral partners—J. Zachary Balasko, Eric Del Pozo, Brya M. Keilson and Victor R. Salgado, accelerating the firm’s continued investment in the growth of its national bankruptcy and business litigation capabilities. Balasko and Keilson join the firm’s Bankruptcy + Reorganizations group in Washington, DC, and Wilmington, DE, respectively, while Del Pozo and Salgado join the Business Litigation group in Hartford, CT, and Washington, DC. These strategic hires enhance the firm’s ability to serve clients navigating complex, high‑stakes bankruptcy, restructuring, government enforcement, and related litigation matters nationwide and expand the firm’s depth and reach across key markets. “These additions meaningfully reinforce the depth and versatility of our business litigation and restructuring platform and reflect a deliberate approach to strengthening these areas in ways that directly benefit our clients,” said J. Michael Wirvin, the firm’s Managing Partner. “Eric, Zak, Brya, and Victor each bring sophisticated experience and sound judgment that enhance our ability to advise clients through some of their most critical and challenging matters. Their arrival reflects our continued focus on building cohesive, multi-disciplinary teams with capabilities that extend across multiple markets.” J. Zachary Balasko joins the firm as a Bankruptcy + Reorganizations partner based in Washington, DC. His practice focuses on complex Chapter 11 cases and bankruptcy‑related litigation across the country, representing debtors, secured creditors, creditors’ committees, and governmental entities. Balasko brings substantial experience from both private practice and prior service with the U.S. Department of Justice, where he handled major insolvency matters involving federal interests. Eric Del Pozo joins Robinson+Cole’s Hartford, CT office as a Business Litigation partner focusing on complex commercial litigation and appellate matters, representing businesses and public entities in regulated industries in high-stakes and sophisticated disputes. Del Pozo brings experience from senior roles in government and private practice, where he has represented clients at both the trial and appellate levels. Brya Keilson joins Robinson+Cole as a Bankruptcy + Reorganizations partner in the firm’s Wilmington, DE office, one of the nation’s leading venues for complex bankruptcy proceeding . She represents debtors, creditors, committees, trustees, and other parties in interest in sophisticated Chapter 11 and Chapter 7 cases. Keilson is widely experienced in contested bankruptcy matters and frequently advises clients on both strategic and practical considerations throughout the restructuring process. Victor Salgado joins Robinson+Cole as a Business Litigation partner in the firm’s Washington, DC office. He brings significant experience from both government and private practice, including eight years as a federal prosecutor with the U.S. Department of Justice in Washington, DC, where he handled high‑profile and complex cases focusing on public corruption as well as crimes involving financial institutions. Salgado will also work closely with the firm’s Bankruptcy + Reorganizations group on contested matters arising in complex restructurings and related litigation. In addition, Destiney Parker-Thompson joins the firm as a Bankruptcy + Reorganizations associate in the Wilmington office. Parker‑Thompson focuses her practice on bankruptcy, restructuring, and related litigation matters, drawing on experience representing debtors, creditors, and financial institutions in complex Chapter 11 cases. She previously served as a judicial law clerk to the U.S. Bankruptcy Court for the District of Delaware and the U.S. Court of Appeals for the Third Circuit, bringing valuable insight to sophisticated restructuring matters. Robinson+Cole’s Bankruptcy + Reorganizations group has recently been recognized for its role in several of the most complex and precedent‑setting restructuring matters in the country, earning multiple national honors for its work in high‑profile Chapter 11 cases and related litigation. The group has guided stakeholders through landmark proceedings—including award‑recognized reorganizations, a first‑of‑its‑kind bankruptcy confirmed with a Section 524(g) injunction, and other transformative restructurings—reflecting the team’s ability to deliver strategic, results‑driven counsel in matters with significant legal and financial implications.

News
Kate Dion and Natale DiNatale Examine the Legal Questions Raised By Sorsby Injunction

Education industry team chair Kathleen Dion and Labor Relations group chair Natale DiNatale discussed the potential ramifications on the NCAA and college athletes in the article, “NCAA to appeal Brendan Sorsby injunction. What it means and how it can win,” published in USA Today, June 8, 2026. Kate pointed out that the injunction is a temporary measure. “This decision is only a preliminary ruling and is subject to appeal. Unless it is overturned, the injunction preserves Sorsby’s opportunity to compete this fall while the underlying case proceeds and allows him to continue preparing for a potential NFL career. For the NCAA, the ruling raises questions about the extent to which courts may review and potentially limit the enforcement of eligibility and competitive-integrity rules in individual cases.”  She continued, “It is also important to recognize that this is one state trial court decision, not a final decision on the merits, and thus its precedential value may be limited. While the court found that Sorsby demonstrated a probable right to the relief that he seeks on his breach of contract and other claims, which is a necessary element for obtaining a temporary injunction — the order does not appear to provide a detailed explanation of the court’s reasoning on that issue. As a result, many of the legal questions raised by the case are likely to remain the subject of further litigation and possible appellate review.” Discussing the foundation of the claim, Natale said, “The underlying dispute looks like a claim that the NCAA failed to accommodate a disability (e.g. an ADA claim based on a gambling addiction). But, it was brought as a breach of contract claim. A contract claim can be brought and maybe kept, in state court, which is likely a friendlier forum for this athlete.” Read the article.

News
Julianna Charpentier Recognized as an “Up & Coming Lawyer”
News
Erica Kerstein Brings Credibility and Business Perspective to New Role as Practice Group Chair

Insurance + Reinsurance group chair Erica J. Kerstein was featured in a Law.com column titled, “How I Made Practice Group Chair,” published on April 15, 2026. In the article, Erica discusses her new role as a practice group chair and how it has expanded her insight into not only the firm’s strategic vision and goals, but the reality of running a business and ensuring that current planning aligns with future goals. “The role provides a window into how individual practices fit into the firm’s overall strategy,” said Erica. “You’re thinking not just about today’s matters, but about where clients are headed, how the industry is changing, and how the firm positions itself to meet those needs.” In addition, Erica also identified “…strengthening client relationships, investing in our people, and staying ahead of emerging issues—particularly around technology and artificial intelligence in the insurance space…” as key priorities for the practice. Read the article.

News
Dana Horton Ascends to Presidency of Rhode Island Bar Association
News
Robinson+Cole’s People-First Culture Recognized in Vault’s 2027 Rankings
News
Robinson+Cole Integrates Thomson Reuters’ Deep Research into Newcode.ai Platform to Advance Secure, Verifiable Legal Research

Robinson+Cole has expanded its firmwide artificial intelligence (AI) capabilities by integrating Thomson Reuters’ Deep Research directly into Newcode.ai, the agentic AI platform implemented last year by the firm to support legal workflows across practices. With this integration, Robinson+Cole is one of only two law firms with direct access to the Deep Research API—and the only firm deploying it through Newcode.ai. Building on its 2025 partnership with Newcode.ai —making Robinson+Cole the first Am Law 200 firm to adopt the platform—the firm has continued to expand its AI capabilities as part of a broader strategy focused on secure deployment, ethical use, and seamless integration into daily legal work. The integration enables Robinson+Cole attorneys to conduct complex, multi‑step legal research and receive verifiable, citation‑backed responses grounded in trusted Thomson Reuters content. By embedding Deep Research into Newcode.ai, Robinson+Cole continues to build on its deliberate, governance‑first approach to AI adoption while delivering meaningful, practice‑ready innovation for its lawyers and clients. “Innovation at Robinson+Cole is grounded in client service, security, and practicality,” said J. Michael Wirvin, Managing Partner of Robinson+Cole. “By incorporating Thomson Reuters’ Deep Research directly into Newcode.ai, we are providing our lawyers with advanced research capabilities in a secure environment fully controlled by the firm that aligns with our standards for data governance, accuracy, and responsible AI use. This integration reflects our continued focus on adopting technology thoughtfully to support our attorneys and deliver value to our clients.” The addition of Deep Research allows attorneys to: Perform sophisticated legal research using agentic workflows that mirror real‑world legal reasoning Receive structured, verifiable responses grounded in Thomson Reuters data Streamline research processes while maintaining rigorous quality and accuracy standards Work entirely within Robinson+Cole’s firm‑controlled AI environment  “Our integration of the Thomson Reuters’ Deep Research API with Newcode represents a defining moment in our AI strategy,” said Chief Data Officer Jim Merrifield. "We are incredibly proud to be the first firm to bring this capability to life—unlocking the power of trusted legal data directly within the workflows our lawyers and business professionals rely on every day. This is exactly how we maximize our technology investments: by connecting best-in-class data sources through APIs into a unified platform, so the technology meets our people where they work, enhances their judgment, and accelerates better outcomes for our clients.” Robinson+Cole’s AI program is guided by firmwide policies, mandatory training, and ongoing oversight to ensure responsible use of emerging technologies. The firm’s approach emphasizes measured adoption, strong information governance, and alignment with client expectations, rather than one‑off experimentation. This latest enhancement underscores Robinson+Cole’s commitment to remaining forward‑thinking in its use of technology, while ensuring that innovation serves the firm’s clients, lawyers, and long‑term strategic goals.

News
Robinson+Cole Recognized Across Practices and Regions with 46 Chambers USA 2026 Rankings
News
Robinson+Cole Recognized at 2026 Women, Influence & Power in Law Awards
News
Robinson+Cole Expands Philadelphia Office at Landmark Liberty Place
News
Robinson+Cole Expands National Platform with Four Lateral Partners

Robinson+Cole announced the addition of four lateral partners—J. Zachary Balasko, Eric Del Pozo, Brya M. Keilson and Victor R. Salgado, accelerating the firm’s continued investment in the growth of its national bankruptcy and business litigation capabilities. Balasko and Keilson join the firm’s Bankruptcy + Reorganizations group in Washington, DC, and Wilmington, DE, respectively, while Del Pozo and Salgado join the Business Litigation group in Hartford, CT, and Washington, DC. These strategic hires enhance the firm’s ability to serve clients navigating complex, high‑stakes bankruptcy, restructuring, government enforcement, and related litigation matters nationwide and expand the firm’s depth and reach across key markets. “These additions meaningfully reinforce the depth and versatility of our business litigation and restructuring platform and reflect a deliberate approach to strengthening these areas in ways that directly benefit our clients,” said J. Michael Wirvin, the firm’s Managing Partner. “Eric, Zak, Brya, and Victor each bring sophisticated experience and sound judgment that enhance our ability to advise clients through some of their most critical and challenging matters. Their arrival reflects our continued focus on building cohesive, multi-disciplinary teams with capabilities that extend across multiple markets.” J. Zachary Balasko joins the firm as a Bankruptcy + Reorganizations partner based in Washington, DC. His practice focuses on complex Chapter 11 cases and bankruptcy‑related litigation across the country, representing debtors, secured creditors, creditors’ committees, and governmental entities. Balasko brings substantial experience from both private practice and prior service with the U.S. Department of Justice, where he handled major insolvency matters involving federal interests. Eric Del Pozo joins Robinson+Cole’s Hartford, CT office as a Business Litigation partner focusing on complex commercial litigation and appellate matters, representing businesses and public entities in regulated industries in high-stakes and sophisticated disputes. Del Pozo brings experience from senior roles in government and private practice, where he has represented clients at both the trial and appellate levels. Brya Keilson joins Robinson+Cole as a Bankruptcy + Reorganizations partner in the firm’s Wilmington, DE office, one of the nation’s leading venues for complex bankruptcy proceeding . She represents debtors, creditors, committees, trustees, and other parties in interest in sophisticated Chapter 11 and Chapter 7 cases. Keilson is widely experienced in contested bankruptcy matters and frequently advises clients on both strategic and practical considerations throughout the restructuring process. Victor Salgado joins Robinson+Cole as a Business Litigation partner in the firm’s Washington, DC office. He brings significant experience from both government and private practice, including eight years as a federal prosecutor with the U.S. Department of Justice in Washington, DC, where he handled high‑profile and complex cases focusing on public corruption as well as crimes involving financial institutions. Salgado will also work closely with the firm’s Bankruptcy + Reorganizations group on contested matters arising in complex restructurings and related litigation. In addition, Destiney Parker-Thompson joins the firm as a Bankruptcy + Reorganizations associate in the Wilmington office. Parker‑Thompson focuses her practice on bankruptcy, restructuring, and related litigation matters, drawing on experience representing debtors, creditors, and financial institutions in complex Chapter 11 cases. She previously served as a judicial law clerk to the U.S. Bankruptcy Court for the District of Delaware and the U.S. Court of Appeals for the Third Circuit, bringing valuable insight to sophisticated restructuring matters. Robinson+Cole’s Bankruptcy + Reorganizations group has recently been recognized for its role in several of the most complex and precedent‑setting restructuring matters in the country, earning multiple national honors for its work in high‑profile Chapter 11 cases and related litigation. The group has guided stakeholders through landmark proceedings—including award‑recognized reorganizations, a first‑of‑its‑kind bankruptcy confirmed with a Section 524(g) injunction, and other transformative restructurings—reflecting the team’s ability to deliver strategic, results‑driven counsel in matters with significant legal and financial implications.