Daniel Meron

Mr. Meron has argued over 25 cases in the US federal courts of appeals, including two appeals “en banc,” as well as numerous dispositive motions in the federal district courts.

Mr. Meron’s experience includes:

• Successfully defended UnitedHealth in a high profile False Claims Act suit brought by the Department of Justice, obtaining dismissal of DOJ’s entire complaint
• Represented three large drug manufacturers in successful challenge to CMS’s DTC List Price Disclosure Rule
• Represented West Coast medical device manufacturer in off label and reimbursement investigation
• Obtained outright dismissal, and affirmance on appeal, of first post-amendment FCA suit based on alleged inflated AWP reporting
• On behalf of a healthcare company, brought successful APA challenge to CMS’s Part C Overpayment Regulation
• Represented large specialty pharmacy in successful resolution of first DOJ false claims act suit based on drug adherence program
• Obtained dismissal of FCA suit challenging health plan’s gift card health reward program as an alleged kickback
• Represented hospital in a national DOJ investigation into billing for cardiac devices; matter closed with no payment
• Successfully argued before the district court and the First Circuit that the University of Massachusetts Medical School should enjoy 11th Amendment Immunity from FCA suit
• Successfully defended senior executives of a large nursing home chain in HHS OIG exclusion proceeding; matter closed with no action

Publication

• Medicare & Medicaid Reimbursement for Off-Label Uses of Pharmaceuticals and Medical Devices, in OFF-LABEL COMMUNICATIONS: A GUIDE TO SALES & MARKETING COMPLIANCE (Mark Levy ed., Food and Drug Law Inst. 3d ed. 2012)

Selected Speaking Engagements

• “The Time is Still Now: Medicare Advantage/Medicaid Managed Care At the Forefront of Enforcement,” American Health Lawyers Association Fraud and Compliance Forum (2019)
• Webex, “Under the Microscope: Making Sense of Today’s Health Care Enforcement Landscape” (2018)
• “Managed Care: Fraud and Compliance”, Health Care Compliance Association’s 22nd Annual Compliance Institute (2018)
• “Fraud and Compliance Issues for Commercial, Medicare and Medicaid Managed Care Organizations,” ABA National Institute on Health Care Fraud (2018)
• “Statistical Sampling and False Claims Act Liability: Aseracare,” State Bar of Georgia Healthcare Fraud Institute (2017)
• “Medicare Part C Fraud,” 3rd Annual Conference, Qui Tam – False Claims Act Litigation (2016)
• “Introduction to Fraud and Compliance for Commercial Payors and Managed Care Organizations,” ABA National Institute on Healthcare Fraud (2015)
• Guest Lecturer, Cornell Law School, “Materiality under the False Claims Act (Spring 2013)
• “Recent Developments in FCA Liability,” ABA National Institute on Civil FCA and Qui Tam Enforcement (2012)
• “Trends in Enforcement of Off-Label Promotion and Anti-Kickback Prohibitions as Bases for False Claims Act Prosecutions,” AdvaMed MedTech Conference (September 21, 2008)
• “New Trends in Medical Device Fraud and Abuse/Off-Label Promotion Enforcement,” MDMA Medical Technology Executive Forum (October 15, 2008)
• “How Important Is an Indication? Off Label Promotion and Compendia: The Interplay between Compendia Listings of Unapproved Indications and False Claims Act Liability,” FDLI Conference on Better Understanding CMS and its Relationship to FDA, (November 19, 2008)
• “Commercial Speech: What Can The Constitution Protect? A Moot Appellate Court, Analysis of Off-Label Promotion of Medical Devices and the Constitution,” FDLI/FDA 51st Annual Conference, Washington, D.C. (March 27, 2008)
• “Major Legal Developments Affecting the Pharmaceutical and Biotechnology Industries: From the Food and Drug Administration Amendments Act of 2007 to the Supreme Court’ Preemption Docket and Beyond,” Luncheon Address at the FDLI Board of Directors Annual Meeting (October 2007)
• “The Increasing Interplay of ‘Life Sciences’ and ‘Healthcare’ Law,” Keynote Address, American Health Lawyers Association Life Sciences Institute, San Francisco, CA (April 26, 2007)
• “Legal Developments Relevant to the FDA’s Authority,” Address to the 50th Annual FDLI/FDA Annual Conference, Bethesda, MD (April 12, 2007)