Daniel Meron

Daniel 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.

Daniel's experience includes:

False Claims Act Defense

• Representing a healthcare organization in an FCA suit before the US District Court for the Central District of California, in which the DOJ brought the whistleblower suit over alleged overpayments on medical claims
• Defending hospitals in investigations as to coding and billing of certain diagnoses 
• Successfully defended UnitedHealth in a high-profile False Claims Act suit brought by the DOJ, obtaining dismissal of the DOJ’s entire complaint
• 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
• 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

Government-Facing Affirmative Litigation

• Represented three large drug manufacturers in successful challenge to CMS’s DTC List Price Disclosure Rule
• On behalf of a healthcare company brought successful APA challenge to CMS’s Part C Overpayment Regulation definition of “identified”
• Representing large drug manufacturer in constitutional challenge to the Inflation Reduction Act’s drug pricing provisions

Publications

• 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

• “Managed Care Enforcement & Compliance,” HCCA Healthcare Enforcement Compliance Conference (November 5, 2023)
• “Medicare and Medicaid Managed Care Fraud and Enforcement,” ABA National Institute on Health Care Fraud (May 4, 2023)
• “Managed Care Enforcement and Compliance,” Virtual HCCA Healthcare Enforcement Compliance Conference (November 7-9, 2022)
• “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) 

Thought Leadership

• “ACA “Repeal and Replace” Bill Merits Attention from Industry Stakeholders,” Latham & Watkins Client Alert (May 2017)
• “Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases,” Latham & Watkins Client Alert (February 2017)
• “President Obama Signs the 21st Century Cures Act Into Law,” Latham & Watkins Client Alert (December 2016)
• “SCOTUS Upholds Implied Certification for Some Cases But Imposes “Rigorous Materiality Requirement” for FCA Liability,” Latham & Watkins Client Alert (June 2016)
• “Amarin Settles Off-Label Promotion Case Against the FDA,” Latham & Watkins Client Alert (March 2016)
• “Fourth Circuit May Address Use of Statistical Sampling in False Claims Act Actions,” Latham & Watkins Client Alert (July 2015)
• “We've Got Washington Covered - Agency Insight Series,” Latham & Watkins Newsletter (March 2014)
• “CMS Proposes Major Changes to Overpayment Reporting Requirements, Extending Liability to Ten Years,” Latham & Watkins Client Alert (March 2012)
• “Recently Announced Interagency Medicare Fraud Initiative Expands Ongoing Enforcement Activity,” Latham & Watkins Client Alert (June 2009)
• “FDA Issues a Final Guidance on ‘Good Reprint Practices,’” Latham & Watkins Client Alert (January 2009)