Benjamin Koplin consults with Fortune 500 companies, performing complex business analysis to address legal risks stemming from business operations subject to regulatory investigations and litigation. He leads complex investigations and defense teams, and assists in design and implementation of corporate compliance programs and various transactional matters involving health care entities. He works with in-house lawyers, compliance staff and operations professionals to design right-sized risk solutions including information management processes, product architecture and development and technology procurement, ensuring that selected products and solutions will benefit the client's business goals.
Ben focuses primarily on health care compliance and the federal regulation of health care providers and suppliers, medical device and pharmaceutical manufacturers and distributors through the Anti-Kickback Statute, the Stark Law, state and federal false claims acts, and rules governing the privacy and security of health information (HIPAA).
Additionally, Ben has direct experience in dozens of technologies and is an accomplished full stack developer. He and his partner, Jeff Layne, have developed the firm's proprietary information analysis platform, NSight. They use NSight to design matter-specific data models that harmonize client data from multiple systems alongside legal and compliance information. The data models are then deployed through collaborative NSight-posted applications to provide solid and testable defenses and tools in investigations, litigation and risk management matters.
Combining these skills with his legal experience, Ben's approach to solving client's issues is unique and transformative. He performs predictive analytics and writes regression models to tactically display where companies may need to adjust their processes for compliance and regulatory issues. He also leads his clients through process mapping workshops to isolate legal issues from operational issues and uses Six Sigma methodologies and tools to unravel his clients' most difficult problems.
Ben is a part of the firm's global R&D center, as well as the US Business Readiness and Development change leadership initiative, which concentrates on harnessing the creativity of the global firm to find innovative solutions to our clients' legal issues. In this role, he communicates with other lawyers across the globe to ensure that clients have the best solution to meet their needs, whether that be through a technology or process workshop to break down complex issues.
JD, Harvard University Law School, 2006
BA, magna cum laude, Boston University, 2003
While at Boston University, Ben was awarded the prestigious Warren O. Ault Prize for Outstanding Academic Achievement in History. He was admitted to practice law in Texas in 2006.
- Development and implementation of global health care compliance programs for multiple life sciences companies including medical device manufacturers, genetic testing manufacturers and labs, clinical laboratories and durable medical equipment manufacturer/suppliers
- Audit, benchmarking and revision of global health care compliance programs in the life sciences industry including revision of program documents (policies/procedures/work instructions/contracts/sales forms), sales and business unit leadership training, and assistance with ongoing monitoring and audit activities
- Assists life sciences manufacturers, sales organizations and distributors in complying with various transparency laws and regulations, including state laws and the federal Sunshine Act
- Advises life sciences companies on FDA labeling/recall issues, human subjects research protections and clinical trial issues
- Representation of device manufacturer in grand jury investigation and civil litigation regarding business practices
- Advised national DME manufacturer and supplier regarding competitive bidding issues
- Representation of national retail pharmacy chain in coordinated federal and state investigations of dispensing practices affecting Medicaid claims
- Representation of pharmaceutical wholesalers in National Medicaid Fraud Task Force and Texas Attorney General investigations regarding Medicaid rebates and in compliance issues related to drug pedigree rules
- Assisted clients with creation, implementation, assessment, benchmarking and improvement of comprehensive corporate compliance programs including for international medical device manufacturers, DMEPOS suppliers and clinical laboratories to address compliance issues related to, among other topics, the Foreign Corrupt Practices Act, FDA regulatory issues, CLIA certification, Medicare billing practices, clinical research and product development, consultant and vendor relationships, product marketing and education and training activities
- Advised DMEPOS suppliers and drafted memoranda and white papers related to business and legal risks and ramifications of participating in Medicare DMEPOS Competitive Bidding Program, assisted in design of supplier business models regarding same
- Advised life science companies and health care providers on transactions, including on issues relating to federal Medicare anti-fraud and abuse, Texas illegal remuneration laws, the federal Stark law and Anti-Kickback statutes, and FDA regulatory issues
- Prepared memoranda analyzing various hospital-physician arrangements for compliance with federal laws and regulations including the Stark Law and the Anti-Kickback Statute
- Assisted with various transactional matters involving formation of nurse practices, rental and purchase of durable medical equipment, distribution of drug products, obtaining certificates of free sale, participation in Medicare durable medical equipment completive bidding process, analysis and guidance regarding researcher and physician-consultant arrangements, analysis of nutritional supplement labels, many of which included the preparation of purchase, employment and service contracts
- Prepared and analyzed charity care and bad debt policies for compliance with Federal and State law relating to non-profit designation for Hospitals, especially in context of indigent-care lawsuits against hospitals
- Briefed hospital clients on patient, facility and records access rights granted under federal law to Protection & Advocacy Systems, advised on strategy of addressing such Systems' requests for access
- In self-disclosure context, internal investigations and qui tam suits against hospitals for billing and false claims allegations, analyzed documents such as physician recruitment agreements, lease agreements and compliance program policies and procedures for compliance with federal and state laws and rules
- Developed comprehensive guidelines on hospital licensing for newly-constructed hospitals, including all ancillary licenses a hospital may need to secure
- Analyzed documents and interviewed personnel at hospital clinic for violations of state pharmacy and medical board rules and laws and federal drug law, briefed issues and assisted in advising client on self-disclosure and employee relations options
- Participated in two-year-long government investigation of and qui tam suit against international pharmaceutical company relating to off-label marketing and kickbacks to physicians, including full briefing of all issues of liability and arguments relating to propriety of company's actions; directed and oversaw review team of 26 attorneys for document review of over 2 million pages of documents relevant to requests for production
- Briefed state and federal false claims and pharmaceutical issues and prescribing data related to multi-state investigation of pharmacy chain for alleged improper switching of drug dosage forms; assisted client in qui tam relator's fee recovery claims in the same suit
- Prepared white paper to multi-state Medicaid Fraud Task Force analyzing and explaining drug repacker's responsibilities under the Medicaid Drug Rebate Program
Rankings and recognitions
- Texas Rising Star, health care, Thomson Reuters, 2015-2018
- Co-author, "Changes Proposed to Sunshine Act Reporting: Would Remove CME Exclusions May Broaden Availability of 'Indirect-Payment' Exclusions," Compliance Commoner, July 2014
- Co-author, "CMS Delays Data Submission at Least 30 Days," Health Law Update, February 19, 2014
- Co-author, "CMS Offers New Resources and Guidance on Two-Phase Approach to Sunshine Act Reporting," Sunshine Act forecast, February 2014
- Co-author, "New Data Submission Resources Available for Sunshine Act Reporting, Norton Rose Fulbright - Sunshine Act forecast, November 4, 2013
- Co-author, "Industry user guide released," Norton Rose Fulbright - Sunshine Act forecast, August, 19, 2013
- Co-author, "CMS publishes new Sunshine Act resources", Norton Rose Fulbright - Sunshine Act forecast, August, 8, 2013
- Co-author, "The Sunshine Act's international reach," Norton Rose Fulbright - Sunshine Act forecast, July 3, 2013
- Co-author, "CMS Hosts a National Provider Call Relating to the Open Payments Program," Fulbright's Sunshine Alert, May 22, 2013
- Co-author, "Sunshine Act: request for comments; data templates and teaching hospital list available," Fulbright's Sunshine Alert, May 9, 2013
- Co-author, "The Other Side of the Sunshine Act: Reporting Ownership & Investment Interests," Fulbright's Sunshine Alert, March 21, 2013
- Co-author, "Reporting 'Indirect Payments' Under the Sunshine Act: A Closer Look," Fulbright's Sunshine Alert, March 4, 2013
- Co-author, "Tracking Payments: How Should Manufacturers Allocate Food and Beverages?," Fulbright's Sunshine Alert, February 13, 2013
- Co-author, "Highlights of the Sunshine Act's Final Rule Part 1: Key Changes and Clarifications," Fulbright's Sunshine Alert, February 4, 2013
- Co-author, "Final Rule Released for the Sunshine Act," Fulbright's Sunshine Alert, February 1, 2013
- Co-author, "Still No Sunshine," Fulbright's Sunshine Alert, January 11, 2013
- Panelist, "Compliance: Current Investigative Initiatives," Fulbright & Jaworski L.L.P. Eighth Annual Health Law Symposium, Austin, TX, February 2-3, 2012
- Co-presenter, "Governance Issues and the Role of the Compliance Officer" and "Overpayments Part 2: Stark Issues," Legal Issues Boot Camp for Compliance Professionals, Houston, TX, June 7-8, 2011
- "Health Care Reform: An Overview of the 2010 Patient Protection & Affordable Care Act," Paychex CPA Educational Conference, July 29, 2010
Memberships and activities
- State Bar of Texas, Health Law Section
- Texas 4000 for Cancer, pro bono assistance
- Redeemer Presbyterian Church, parish leader
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