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Brian P. Dunphy

Member / Co-Chair, Health Care Enforcement Defense Practice

[email protected]

+1.617.348.1810

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Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Brian advises and counsels health care providers, health plans, Medicare Advantage plans, biotechnology and life sciences companies, and clinical laboratories. He represents them in government investigations, in litigation, at trial, and in arbitration.

In particular, Brian defends companies against government investigations of alleged violations of the FCA and the Anti-Kickback Statute (AKS). He conducts internal investigations and litigates qui tam FCA cases in federal courts around the country. Brian is well-versed in health care regulatory requirements, including in Medicare Advantage and risk adjustment. Brian also represents health plans, biotechnology, life sciences, health care, and technology companies in complex business disputes.

Brian is committed to pro bono work and is a member of the firm’s Pro Bono Committee. He obtained political asylum for a client who was tortured in the Democratic Republic of the Congo, and he secured a residential educational placement for a disabled student. Brian has spent more than a decade advising a non-profit organization dedicated to advancing the study, treatment, and prevention of the effects of concussions and other brain trauma in athletes and other at-risk groups.

Brian is also deeply involved in the Boston community as a member of the Board of Advisors for Life Science Cares, and the Boards of Directors of the Concussion Legacy Foundation and the Volunteers Lawyers Project. He was also a Member of the Boston College Law School Alumni Board.

Before attending law school, Brian was a project manager at Accenture, a management and technology consulting firm, where he provided project management and consulting services. Brian developed project plans and budgets, managed teams to meet project milestones, and worked with client executives to ensure projects met business objectives. He continues to utilize his project management skills working with his clients to manage matters effectively and to deliver timely results.

Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Experience

  • Defended numerous clients, including laboratories, health plans, and Medicare Advantage plans, in government FCA investigations and FCA litigation in jurisdictions around the country
  • Obtained dismissal of a whistleblower’s state and federal FCA claims against a vendor to Medicare Advantage plans. Argued the appeal in the Second Circuit Court of Appeals, which affirmed the district court’s decision
  • Obtained summary judgment in nine related cases against a publicly traded biotechnology company and a pharmaceutical company in multi-jurisdictional product liability disputes involving an FDA-approved pharmaceutical drug
  • Represented construction companies in a state Attorney General’s false claims act investigation related to a construction project
  • Obtained dismissal of a whistleblower’s state and federal FCA claims against a Pharmacy Benefit Manager in federal court, and the Third Circuit Court of Appeals upheld the district court’s decision in our client’s favor
  • Represented a health insurance company in an FCA lawsuit in federal court where relator alleged an industry wide drug-pricing scheme. The court dismissed the case
  • Defended companies against FCA retaliation claims before litigation, in litigation, and at trial
  • Obtained a defense verdict as trial counsel after a week-long federal court jury trial. Plaintiff, a former distributor of our client’s next-generation DNA sequencing machines, filed an 18-count, $100 million complaint against our client
  • Achieved victory in an arbitration for an international life sciences company initiated by one of the company’s suppliers. After an evidentiary hearing, a panel of arbitrators rejected the supplier’s claims and entered judgment for our client on its counterclaim, including recovery of our client’s attorneys’ fees and costs
  • Represented a life sciences company before the International Court of Arbitration of the International Chamber of Commerce in a breach of contract dispute involving the manufacture of diagnostic assays
  • Successfully defended a physician before an Administrative Law Judge against an action by the Massachusetts Board of Registration in Medicine to revoke or suspend the physician’s license
  • Conducted an internal investigation of a health care provider and prepared a self-disclosure to the U.S. Department of Health and Human Services, Office of Inspector General (OIG)
  • Successfully opposed the OIG’s proposed exclusions of a physician from federal health care programs
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viewpoints

Over the past several weeks, the Firm has received a number inquiries from clients (on both coasts) who are interested in manufacturing or selling test kits, respirators, masks, and other PPE in response to the COVID-19 pandemic, with respect to potential liability risks associated with such activities.
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The Department of Justice recently filed suit against Anthem, Inc. (Anthem) alleging that the Medicare Advantage Organization (MAO) violated the False Claims Act when it knowingly failed to delete inaccurate diagnosis codes submitted to the Centers for Medicare and Medicaid Services (CMS) for risk adjustment purposes. As predicated in our 2020 outlook post, we continue to see enforcement activity and ongoing litigation against Medicare Advantage plans. Notably, this trend is referenced in SDNY’s complaint, alleging that the government has “sought to enforce” data accuracy in the risk adjustment system by “actively pursuing legal remedies against [] MAOs that have knowingly submitted inaccurate and untruthful diagnosis data to CMS[.]” The complaint provides four examples of settlements obtained from 2012-2019 against MAOs and healthcare providers who, purportedly like Anthem, submitted inaccurate diagnosis codes to CMS or allegedly failed to delete unsupported diagnosis codes.
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Landmark AseraCare Case Finally Ends in Settlement

March 2, 2020 | Blog | By Samantha Kingsbury, Brian Dunphy, Laurence Freedman

As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services lacking “medical necessity” violate the False Claims Act (FCA) as well as to efforts by providers to defend such cases. On Wednesday, we learned that the AseraCare case has reached its dramatic conclusion with an agreement to resolve $200 million in alleged damages for the agreed amount, as reported by AseraCare, of $1 million.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends

January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch, Nicole Henry, Clare Prober

As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care enforcement tool.  This post will give an overview of our article, which covers these issues and more in great detail.
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CMS Finalizes Changes Expanding the Scope of the Open Payments Program

November 18, 2019 | Blog | By Brian Dunphy, Rachel Yount

On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. Perhaps most importantly, CMS broadened the list of Covered Recipients. Starting for data collection for CY 2021, manufacturers will be required to track and report payments and transfers of value made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. CMS also added three new nature of payment categories – debt forgiveness, long-term medical supply or device loan, and acquisitions. CMS also consolidated the two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – into one payment category for all continuing education programs. Lastly, in a move expected to impose a substantial burden on medical device manufacturers, CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.
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On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment.  Instead, there must be proof of an objective falsehood. More than three years have passed since the U.S. District Court for the Northern District of Alabama issued the series of rulings that gave rise to the Eleventh Circuit case. 
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Open Payments Program Expansion

August 12, 2019 | Blog | By Brian Dunphy, Rachel Yount

On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced more proposed changes to the Open Payments Program, otherwise known as the Sunshine Act. The proposed changes include new requirements that are expected to impose burdens on pharmaceutical and medical device manufacturers.
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The Third Circuit Court of Appeals recently dismissed a relator’s False Claims Act (“FCA”) case under the pre-Affordable Care Act (“ACA”) version of the public disclosure bar. The court decided in U.S. ex rel. Denis v. Medco that to escape the FCA’s public disclosure bar by qualifying as an “original source” under the pre-ACA version of the FCA, a relator must have first-hand, non-derivative knowledge of conduct giving rise to the FCA claim.
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FCA Defendant Abandons Petition Before the Supreme Court

May 22, 2019 | | By Samantha Kingsbury, Brian Dunphy

This latest installment in our ongoing coverage of the Polukoff False Claims Act (FCA) qui tam case might be one of our last posts about the case. Last week, Intermountain Health Care, Inc. and IHC Health Services, Inc. d/b/a Intermountain Medical Center (Intermountain), one of the hospital defendants in this matter, which had previously filed a Petition for a Writ of Certiorari with the U.S. Supreme Court on issues relevant to this case (as we reported in February), filed an Unopposed Motion to Dismiss before the high court.
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As part of our ongoing discussion of the Polukoff False Claims Act (FCA) qui tam case (involving allegations that certain heart procedures performed by a cardiologist, and billed for by two hospital defendants, were not medically necessary), we reported in February that some defendants filed a petition for a writ of certiorari with the United States Supreme Court. 
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News & Press

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BOSTON – Twenty-five Mintz attorneys have been named to Boston Magazine’s Top Lawyers list.
BOSTON – Mintz has appointed Brian Dunphy as Co-Chair of the firm’s Health Care Enforcement Defense Group with immediate effect. Brian joins Karen Lovitch, who also serves as Chair of the Health Law Practice, in joint leadership.
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In its second annual edition, 28 Mintz attorneys were named to Boston Magazine’s Top Lawyers list.
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Mintz Members Brian P. Dunphy, Joanne S. Hawana, and Jennifer B. Rubin co-authored a Bloomberg Law insights column examining potential legal liabilities for employers implementing Covid-19 workplace vaccination programs, explaining that immunity under the federal Public Readiness and Emergency Preparedness Act (PREP Act) is not absolute.
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Mintz Members Kevin Ainsworth and Brian Dunphy co-authored an article published by New York Law Journal that analyzes the conditions for, and limitations of, the Public Readiness and Emergency Preparedness Act (PREP Act) immunity during the COVID-19 global health crisis.
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Mintz Members Brian Dunphy and Laurence Freedman, and Member and Co-Chair of the firm’s Health Law Practice Karen Lovitch co-authored this Law360 expert analysis article examining trends in U.S. Department of Justice health care enforcement in 2019, noting that the False Claims Act remains the government’s most powerful civil health care enforcement tool.
Brian Dunphy a Member in the Boston Mintz office authored the second article in a four-part series discussing some of 2017’s most important False Claims Act (FCA)-related court decisions.
Mintz has elevated five attorneys to Members of the firm. “These attorneys consistently demonstrate excellence in the delivery of legal services to the firm’s clients,” said Bob Bodian, Managing Member.
This is the fourth and final installment of a series from Mintz’s Health Law team recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
Fifty-three Mintz attorneys have been named Massachusetts Super Lawyers for 2016 and thirty-one have been named Massachusetts Rising Stars. The findings will be published in the November 2016 issue of Boston Magazine and in a stand-alone magazine, New England Super Lawyers. 
Mintz Members Brian Dunphy and Larry Freedman authored this BNA’s Medicare Report article discussing the long-awaited final Medicare Overpayment Rule from the Centers for Medicare & Medicaid Services.
Brian Dunphy, a Health Law and Litigation attorney, is quoted in this Becker’s Hospital Review piece on the Center for Medicare and Medicaid Services’ final rule.
Mintz Member Brian Dunphy is quoted in this Inside CMS article on the Center for Medicare and Medicaid Service's (CMS) final rules requiring healthcare providers and suppliers to report and return overpayments by a certain date.
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Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Recognition & Awards

  • Boston Magazine Top Lawyers – Health Care Law (2022-2023)

  • Volunteer Lawyers Project: 2019 Denis Maguire Award 

  • Included on the Massachusetts Super Lawyers Rising Star Health Care list 

  • Greater Boston Chamber of Commerce, Boston Future Leaders Program 

  • Boston Bar Association Public Interest Leadership Program 

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Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Involvement

  • Board of Advisors, Life Science Cares
  • Board of Directors, Volunteer Lawyers Project of the Boston Bar Association
  • Board of Directors, Concussion Legacy Foundation
  • Alumni Board Member, Boston College Law School
  • Member, Boston Bar Association
  • Member, Massachusetts Bar Association
  • Member, American Bar Association
  • Member, American Health Lawyers Association
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Brian P. Dunphy

Member / Co-Chair, Health Care Enforcement Defense Practice

Boston