Robinson Cole LLP
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Compliance, Fraud + Abuse in Healthcare

Robinson+Cole’s Health Law group has extensive experience with all facets of health care compliance and fraud and abuse issues. We have provided compliance counsel, assistance, and representation for publicly traded, privately held, nonprofit, for-profit, and other health care provider entities, including hospitals, laboratories, physician hospital organizations, physician groups and individual practices, home health care agencies, hospice and nursing home providers, dialysis suppliers, durable medical equipment suppliers, information technology and medical device companies, and others involved in health care delivery.

Our lawyers have had experience assisting health care providers regarding the application of health care fraud and abuse laws, including the federal Anti-Kickback Statute, Stark Law, Eliminating Kickbacks in Recovery Act, Civil Monetary Penalties Statute, and False Claims Act. Our assistance addresses the full spectrum of health care compliance, including but not limited to audits, self-reporting, and fraud and abuse analysis and defense issues.

We have worked with a broad range of clients in the development and ongoing operation and review of compliance programs, compliance initiatives, counseling regarding appropriate contractual relationships, and other responses to the rapidly evolving health care regulatory landscape. Given the increased risk of and consequences for noncompliance, our team keeps abreast of developments to help clients navigate the complicated layers of laws and regulations. Such assistance ranges from conducting gap analyses and providing advice and counsel on health care compliance on specific issues to determine whether an appropriate compliance response or corrective action may be necessary to responding to fraud and abuse investigations.

Robinson+Cole supports clients in establishing and evaluating compliance programs with particular focus on federal and state fraud and abuse false claims acts, the Anti-Kickback Statute, the Stark Law, and other compliance-related matters. Such counseling includes internal counseling and review in a preemptive manner as well as responding to investigations and other enforcement initiatives. We have supported clients in assessing appropriate structures for compliance programs, including developing written policies and procedures, developing compliance training programs and initiatives, and performing periodic reviews and redesigns of monitoring and reporting systems.

Given our health care lawyers’ collective decades worth of experience, we have guided clients in reviewing and developing a number of voluntary self-disclosure matters as well as in responding to investigative subpoenas and other enforcement actions. While we are focused on prevention before issues arise, we are also well-positioned to respond to government investigations and audits that are becoming increasingly prevalent in the highly regulated health care marketplace.

In addition, Robinson+Cole counsels clients in transactions to promote compliance with federal, state, anti-kickback, and physician self-referral laws. Our experience and background allow us to counsel clients on structuring compliant arrangements at the start of negotiations and as transactions proceed.

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.

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

Advise + Represent Clients in CT DSS Proceedings

Regularly advise and represent clients in proceedings before the Connecticut Department of Social Services regarding financial audits, administrative sanctions and Title XIX appeals.

Not-For-Profit Health Care Provider Representation

Regular representation of not-for-profit health care providers in connection with corporate reorganizations, governance issues and revisions to corporate governance documents.



Publications


HRSA Publishes 340B Rebate Pilot Program FAQs teaser
August 21, 2025

HRSA Publishes 340B Rebate Pilot Program FAQs

Health Law Diagnosis
December 18, 2024

Labs in Court: A Full Circle

G2 Intelligence

Seth and Danielle kick off the New Year reviewing five cases resolved or filed by the U.S. Department of Justice (DOJ) in the fourth quarter of 2024, noting that many of the cases involved the same themes seen earlier in the year: lack of medical necessity; and kickbacks to telemedicine companies, medical providers, and independent marketers. While there has been significant focus on individual accountability, the authors highlight the DOJ’s continuing focus on labs’ taking proactive steps to ensure compliance, the medical necessity of the testing they bill for, and the careful monitoring of their sales and marketing staff. Read the article.

Legal Update: Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act teaser
December 20, 2021

Legal Update: Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act

HRSA Publishes 340B Rebate Pilot Program FAQs teaser
August 21, 2025

HRSA Publishes 340B Rebate Pilot Program FAQs

Health Law Diagnosis
December 18, 2024

Labs in Court: A Full Circle

G2 Intelligence

Seth and Danielle kick off the New Year reviewing five cases resolved or filed by the U.S. Department of Justice (DOJ) in the fourth quarter of 2024, noting that many of the cases involved the same themes seen earlier in the year: lack of medical necessity; and kickbacks to telemedicine companies, medical providers, and independent marketers. While there has been significant focus on individual accountability, the authors highlight the DOJ’s continuing focus on labs’ taking proactive steps to ensure compliance, the medical necessity of the testing they bill for, and the careful monitoring of their sales and marketing staff. Read the article.

Legal Update: Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act teaser
December 20, 2021

Legal Update: Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act


Events


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

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

KnowledgeBridge: Proactive Approaches to Compliance: A Preventative Checkup

Jan 29 2026
Consero Healthcare Chief Ethics & Compliance Officer Forum
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

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

60-Day Rule – What Providers Need to Know About Reporting and Returning Overpayments in 2025

Dec 4 2025
HFMA / NEHIA Joint 2025 Compliance & Internal Audit Conference
Past

Lab Compliance and Test Utilization: Prepare for 2026 and Beyond

Oct 28 2025
Cardinal Health’s Lab Briefing Series
Past

KnowledgeBridge: Proactive Approaches to Compliance: A Preventative Checkup

Jan 29 2026
Consero Healthcare Chief Ethics & Compliance Officer Forum
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

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

60-Day Rule – What Providers Need to Know About Reporting and Returning Overpayments in 2025

Dec 4 2025
HFMA / NEHIA Joint 2025 Compliance & Internal Audit Conference
Past

Lab Compliance and Test Utilization: Prepare for 2026 and Beyond

Oct 28 2025
Cardinal Health’s Lab Briefing Series