Robinson Cole LLP
High Contrast Mode
Marquee

Health Law

Robinson+Cole’s mission is to provide high-quality legal services with special attention to clients’ needs and time constraints while always supporting their business objectives. We understand the significant challenges facing health care clients today and are committed to helping them navigate complex health care law and regulatory issues.

Business Strategy

Robinson+Cole's Health Law group includes experienced health care attorneys trained to advise clients on meeting business objectives within the confines of a complicated legal and regulatory environment. Members of the Health Law group understand the urgency of our clients’ issues, the complexity of an ever-evolving health care environment, and the challenges of competition, regulation, and resource allocation. We focus on providing practical and responsive counsel to our clients. We represent the spectrum of health care clients, including hospitals, laboratories, home health care agencies, hospice agencies, long-term care facilities, provider networks, durable medical equipment suppliers, ambulatory surgical centers, information technology and medical device companies, physicians and other individual providers, substance abuse clinics, and outpatient facilities. We also routinely work with in-house counsel or serve as outside general counsel.

Health Care Industry Legal Strength

The firm’s extensive health care law experience allows us to provide creative, sophisticated, and practical solutions to the problems facing a diverse health care community. We are sensitive to the impact that health industry dynamics have on our clients’ decision-making. Our team has a core group of health care lawyers, who are supported by lawyers from our firm’s corporate, finance, tax, tax-exempt organizations, emerging technologies, intellectual property, litigation, immigration, labor and employment, benefits, and real property practice areas. Robinson+Cole’s Government Relations + Lobbying group is also known, throughout the region, for its understanding of the issues facing health care entities.

Personal Service

Our commitment is to provide legal services in a prompt and efficient manner, tailored to our clients’ needs. With this in mind, we have an answering service that is available 24 hours a day, seven days a week to ensure that urgent health law needs are met beyond standard business hours. Furthermore, at Robinson+Cole, we believe that knowing our clients and their staff is essential to providing quality legal services. We are committed to knowing and understanding the people who are integral to our clients’ needs.

Our Health Law group regularly publishes news and developments on fraud and abuse, government enforcement, Medicare and Medicaid, reimbursement, hospitals and health systems, pharmaceuticals, medical devices, and other areas of interest for the health care and life sciences industries to the Health Law Diagnosis blog.

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

Represented Enexia HBM LLC in Joint Venture Agreement

Served as legal counsel to Enexia HBM LLC, a pharmacy and health-related services company headquartered in New York, NY, in its joint venture agreement with Interchange RX, LLC, an Oklahoma-based hospice pharmacy benefits manager. 

Read More
Represented Enexia HBM LLC in Joint Venture Agreement

Represented Vast Medical Group in the Investment by Sumitomo Corporation

Represented Vast Medical Group, a management service organization dedicated to linking and building diabetic medical equipment suppliers with patients and healthcare professionals, in the investment by Sumitomo Corporation through its subsidiary Sumitomo Corporation of America.

Read More


Publications


March/April 2026

How PBM Reform Suddenly Got Rolling

Massachusetts Bar Association Section Review
OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk teaser
April 24, 2026

OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk

Health Law Diagnosis
Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority teaser
March 5, 2026

Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

Health Law Diagnosis
March/April 2026

How PBM Reform Suddenly Got Rolling

Massachusetts Bar Association Section Review
OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk teaser
April 24, 2026

OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk

Health Law Diagnosis
Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority teaser
March 5, 2026

Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

Health Law Diagnosis
Hospitals Face New Attestation and NPI Requirements for Off-Campus Outpatient Locations by January 1, 2028 teaser
February 25, 2026

Hospitals Face New Attestation and NPI Requirements for Off-Campus Outpatient Locations by January 1, 2028

Health Law Diagnosis
HRSA Requests Comments on Second Iteration of 340B Rebates teaser
February 19, 2026

HRSA Requests Comments on Second Iteration of 340B Rebates

Health Law Diagnosis
Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities teaser
February 4, 2026

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities

Health Law Diagnosis
Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy Practices teaser
February 3, 2026

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy Practices

Health Law Diagnosis
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


Hospitals Face New Attestation and NPI Requirements for Off-Campus Outpatient Locations by January 1, 2028 teaser
February 25, 2026

Hospitals Face New Attestation and NPI Requirements for Off-Campus Outpatient Locations by January 1, 2028

Health Law Diagnosis
HRSA Requests Comments on Second Iteration of 340B Rebates teaser
February 19, 2026

HRSA Requests Comments on Second Iteration of 340B Rebates

Health Law Diagnosis
Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities teaser
February 4, 2026

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities

Health Law Diagnosis
Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy Practices teaser
February 3, 2026

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy Practices

Health Law Diagnosis
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

News


April 27, 2026

Ivy Miller Shares Update on Regulatory Reform of Pharmacy Benefit Managers in Massachusetts

Health Law group member Ivy K. Miller authored the article, “How PBM Reform Suddenly Got Rolling,” published in the March/April 2026 issue of the Massachusetts Bar Association’s Health Law Section Review. In the article, Ivy points out that there has been a significant shift in how pharmacy benefit managers (PBMs) are regulated at both the state and federal levels. “PBMs wield substantial leverage to bargain with drug companies and influence drug prices. One service that PBMs provide is to negotiate rebates that the drug companies pay to health plans. While lower co-pays may, in the short term, be a benefit to patients, high rebates typically result in drug companies raising the list price of the drug over time, which means higher consumer costs.” Ivy explains that bills at the federal level and in many states across the country, including Massachusetts, have laid out creative strategies for mitigating PBMs’ various revenue streams. In Massachusetts, the newly established application for licensure requires extensive documentation, including audited financial statements, disclosure of any “material ownership interest(s)” in any entity “whose business impacts the PBM,” and reporting of all claims, including the amounts of those claims, paid for Massachusetts residents in the prior year. “Requiring Massachusetts state licensure and reporting and federal attempts to rein in PBM compensation represent significant government actions toward controlling harms alleged as a result of PBMs’ market control, particularly for an industry that has been the subject of much scrutiny but little action to date.” Read the article.   

Massachusetts Bar Association, Health Law Section Review
April 22, 2026

Danielle Tangorre Explains Significance of Groundbreaking Decision for Clinical Laboratories

Dark Report
G2 Intelligence’s Lab Industry Advisor
March 23, 2026

Danielle Tangorre Discusses Pathology Arrangement Scrutiny in Healthcare

​​​​​​​AHLA's “Speaking of Health Law” Podcast
April 27, 2026

Ivy Miller Shares Update on Regulatory Reform of Pharmacy Benefit Managers in Massachusetts

Health Law group member Ivy K. Miller authored the article, “How PBM Reform Suddenly Got Rolling,” published in the March/April 2026 issue of the Massachusetts Bar Association’s Health Law Section Review. In the article, Ivy points out that there has been a significant shift in how pharmacy benefit managers (PBMs) are regulated at both the state and federal levels. “PBMs wield substantial leverage to bargain with drug companies and influence drug prices. One service that PBMs provide is to negotiate rebates that the drug companies pay to health plans. While lower co-pays may, in the short term, be a benefit to patients, high rebates typically result in drug companies raising the list price of the drug over time, which means higher consumer costs.” Ivy explains that bills at the federal level and in many states across the country, including Massachusetts, have laid out creative strategies for mitigating PBMs’ various revenue streams. In Massachusetts, the newly established application for licensure requires extensive documentation, including audited financial statements, disclosure of any “material ownership interest(s)” in any entity “whose business impacts the PBM,” and reporting of all claims, including the amounts of those claims, paid for Massachusetts residents in the prior year. “Requiring Massachusetts state licensure and reporting and federal attempts to rein in PBM compensation represent significant government actions toward controlling harms alleged as a result of PBMs’ market control, particularly for an industry that has been the subject of much scrutiny but little action to date.” Read the article.   

Massachusetts Bar Association, Health Law Section Review
April 22, 2026

Danielle Tangorre Explains Significance of Groundbreaking Decision for Clinical Laboratories

Dark Report
G2 Intelligence’s Lab Industry Advisor
March 23, 2026

Danielle Tangorre Discusses Pathology Arrangement Scrutiny in Healthcare

​​​​​​​AHLA's “Speaking of Health Law” Podcast
January 13, 2026

Les Levinson Shares Insight on Hospice 2026 M&A Outlook

Hospice News
December 4, 2025

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

December 2, 2025

Eight Robinson+Cole Lawyers Named “Top Lawyers 2025”

Boston Magazine
Eight Robinson+Cole Lawyers Named “Top Lawyers 2025” teaser
November 14, 2025

Robinson+Cole Secures Top Rankings in 2026 Edition of Best Law Firms®

Firm earns 6 national and 46 first-tier rankings in Boston, Hartford, New York, Rhode Island, and Stamford Markets
Robinson+Cole Secures Top Rankings in 2026 Edition of Best Law Firms® teaser
November 12, 2025

Danielle Tangorre Shares 2026 Predictions Citing AI, Audits and Increased Enforcement Facing Clinical Labs

G2 Intelligence
November 6, 2025

Robinson+Cole Commends 62 Attorneys Recognized in 2025 Super Lawyers®

Recognition spans key regions and highlights the firm’s seasoned practitioners and emerging leaders in many business transactions and litigation practices
Robinson+Cole Commends 62 Attorneys Recognized in 2025 <i>Super Lawyers</i>® teaser

January 13, 2026

Les Levinson Shares Insight on Hospice 2026 M&A Outlook

Hospice News
December 4, 2025

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

December 2, 2025

Eight Robinson+Cole Lawyers Named “Top Lawyers 2025”

Boston Magazine
Eight Robinson+Cole Lawyers Named “Top Lawyers 2025” teaser
November 14, 2025

Robinson+Cole Secures Top Rankings in 2026 Edition of Best Law Firms®

Firm earns 6 national and 46 first-tier rankings in Boston, Hartford, New York, Rhode Island, and Stamford Markets
Robinson+Cole Secures Top Rankings in 2026 Edition of Best Law Firms® teaser
November 12, 2025

Danielle Tangorre Shares 2026 Predictions Citing AI, Audits and Increased Enforcement Facing Clinical Labs

G2 Intelligence
November 6, 2025

Robinson+Cole Commends 62 Attorneys Recognized in 2025 Super Lawyers®

Recognition spans key regions and highlights the firm’s seasoned practitioners and emerging leaders in many business transactions and litigation practices
Robinson+Cole Commends 62 Attorneys Recognized in 2025 <i>Super Lawyers</i>® teaser

Events


Past

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

Apr 28 2026
2026 Executive War College
Past

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

Apr 28 2026
2026 Executive War College
Past

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

Apr 28 2026
2026 Executive War College
Past

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

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

AI Governance and Adoption: Insights from one Health System’s Experiences

Mar 10 2026
MHA Hot Topic Webinar Series
Past

KnowledgeBridge: Proactive Approaches to Compliance: A Preventative Checkup

Jan 29 2026
Consero Healthcare Chief Ethics & Compliance Officer Forum
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

AI Governance and Adoption: Insights from one Health System’s Experiences

Mar 10 2026
MHA Hot Topic Webinar Series
Past

KnowledgeBridge: Proactive Approaches to Compliance: A Preventative Checkup

Jan 29 2026
Consero Healthcare Chief Ethics & Compliance Officer Forum

Health Law Diagnosis


How PBM Reform Suddenly Got Rolling

Below is an excerpt of an article published in the Massachusetts Bar Association’s Section Review. Recent months have seen a significant shift in how pharmacy benefit managers (PBMs) are regulated at both the state and federal levels. PBMs are hired by health plans to manage administrative and other duties, while also serving as intermediaries by... Continue Reading

Visit Blog

OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk

On April 23, 2026, the HHS Office of Inspector General (OIG) quietly—but pointedly—added two new FAQs to its “General Questions Regarding Certain Fraud and Abuse Authorities.” Although the principles articulated are not new, the timing and clarity of these FAQs reflect OIG’s continued effort to correct common—and risky—misunderstandings in the health care industry regarding the... Continue Reading

Visit Blog

Massachusetts HPC Proposes to Update Material Change Reporting Requirements to Align with Newly Expanded Oversight Authority

On February 5, 2026, the Massachusetts Health Policy Commission (HPC) published proposed amendments to its Material Change regulations at 958 CMR 7.00 (the Proposed Amendments). Among other things, the Proposed Amendments broaden the HPC’s market review authority by subjecting more transactions to the HPC’s Material Change Notice (MCN) process and provide the HPC greater latitude... Continue Reading

Visit Blog

Hospitals Face New Attestation and NPI Requirements for Off-Campus Outpatient Locations by January 1, 2028

The Consolidated Appropriations Act of 2026, HR 7148 (the Act), just signed into law on February 3, 2026, ended a brief government shutdown and includes multiple provisions with a critical impact on health care organizations. We have previously covered the Act’s renewal and extension through 2027 of COVID-era Medicare telehealth flexibilities and its revisions to... Continue Reading

Visit Blog

HRSA Requests Comments on Second Iteration of 340B Rebates

On February 17, 2026, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) regarding the use of rebates within the 340B Program. After an unsuccessful first attempt at deploying a rebate model late last year (as we previously wrote about here and here), HRSA is now seeking “input from interested parties... Continue Reading

Visit Blog

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities

This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. On February 3, 2026, President Trump signed HR 7148, the Consolidated Appropriations Act, 2026 (“the Act”) ending the 4-day partial government shutdown. The Act, part of a broader fiscal year (FY) 2026 spending package, includes a further... Continue Reading

Visit Blog

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... Continue Reading

Visit Blog

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy Practices

February 16, 2026, is the deadline for each HIPAA covered entity to update its Notice of Privacy Practices (NPP) to incorporate new regulatory requirements enacted in 2024. Specifically, HIPAA-covered entities (including health care providers and health plans) are required to review and revise their NPPs as necessary to ensure compliance with a 2024 federal rulemaking... Continue Reading

Visit Blog

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... Continue Reading

Visit Blog

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... Continue Reading

Visit Blog