Frier Levitt, established in 2000, is a national boutique law firm focused exclusively on Healthcare and Life Sciences and has offices in Pine Brook, NJ and New York City. In the life sciences industry, Frier Levitt represents pharmacies of all kinds and assists with regulatory, transactional, and litigation matters.
Frier Levitt provides comprehensive legal services to our healthcare clients, including corporate and transactional services, regulatory advice, and litigation support. The firm’s healthcare clients include large physician group practices, hospitals, hospital medical staff, ambulatory surgery centers, laboratory companies, as well as the complete panoply of ancillary service providers.
Frier Levitt attorneys are licensed in many states and admitted in multiple federal courts throughout the country.
Maze of Regulations
Frier Levitt’s attorneys have decades of experience negotiating the complicated landscape, with an eye towards providing our clients with advice and counsel that assists them in developing programs and arrangements that comport with all applicable laws. Our depth of understanding of health care allow us to quickly understand the objectives of our clients, map out a viable strategy, spot issues of regulatory concern, and develop solutions. We provide regulatory guidance regarding Federal and State healthcare laws, including the Affordable Care Act (ACA), the False Claims Act (FCA), the Anti-Kickback Statute, Any Willing Provider Laws, Civil and Criminal Fraud and Abuse Laws, the Stark Law, Antitrust Laws, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH), the Food, Drug and Cosmetics Act (including Sections 503A and 503B), the Controlled Substances Act and DEA rules and regulations, and State Pharmacy Practice Acts.
Frier Levitt offers a full-service transactional department with experience representing both Buyers and Sellers. We have represented clients in transactional matters ranging from small medical practice or single-pharmacy acquisitions, to several hundred million-dollar transactions. Our attorneys identify regulatory, operational and financial risks to fully educate our Buyers, giving them an opportunity to adjust their offer price to reflect any hidden risks uncovered during the due diligence process. Frier Levitt has broad experience in sell-side private equity acquisitions, and has experience counseling large, platform medical practices on how to prepare for and consummate private equity deals. On the life sciences side, pharmacy transactions involve unique issues that require industry expertise and experience, due in great measure to the unique change of ownership laws in most states and the varied reporting requirements of the PBMs. We are well versed in assuring proper conveyance of licenses and PBM contracts. We also counsel clients pre-closing on the various pitfalls that accompany transactional models. Further, we utilize our industry knowledge to analyze every document relative to a transaction, including audits, operating procedures, PBM contracts, and therapeutic class-specific trends in auditing and reimbursement, to uncover any underlying obstacles a Buyer may face post-closing.
With regard to our robust Litigation Department, we represent numerous clients in intra-corporate disputes, restrictive covenant litigation, False Claims Act investigations, Qui Tam, Self-Disclosure, investigative subpoenas, healthcare fraud investigations and various other high stakes matters. These matters involve intense document review and production, novel legal and often clinical issues and attention to detail. We have handled complex class actions in the healthcare and life sciences spaces, including ones against publicly traded companies such as Medco Health Solutions, Inc. and Express Scripts, Inc. In terms of our ability to handle complex and massive document reviews, we have routinely handled complex discovery in both civil and criminal investigations involving millions of pages of documents, e-mails and electronic files. We routinely use electronic discovery vendors to help efficiently review and produce discovery. It is simply not possible to draft probing and practical discovery that will be “useful” in a healthcare and life sciences trial, without the litigation attorneys having a deep bench of clinical, business and legal understanding. Our trial lawyers frequently consult with our clinician attorneys and regulatory attorneys in crafting litigation strategies.
Frier Levitt provides a comprehensive regulatory counsel to the Healthcare and Life Sciences industries. Nearly every healthcare transaction comes with potential federal and state fraud and abuse issues. Frier Levitt has handled hundreds of fraud and abuse cases involving anything from: a medical practice, pharmacy or laboratory subleasing real estate from a referral source, investing in an ambulatory surgical center, entering a joint venture agreement with a hospital, or investing in a new healthcare modality. Frier Levitt provides counsel to ensure compliance with applicable fraud and abuse laws, including Federal and State Anti-Kickback Laws and Regulations, Federal and State Self-Referral Prohibitions (Stark Law), False Claims Act, Federal Healthcare Fraud Statute, State and Federal Insurance Fraud and State Commercial Bribery Criminal Statutes.
The Firm also understands state government. Some of our attorneys have extensive experience working on behalf of the State of New Jersey, specifically with the Division of Law and the Division of Criminal Justice. Indeed, many of our attorneys have worked in the New Jersey Division of Law or Criminal Justice. Because we have a diverse team of attorneys, we take a collaborative and cross departmental approach to representing our clients, integrating our corporate, transactional, litigation and regulatory departments to provide the most comprehensive services.
In addition to pharmacies and other healthcare providers, we have counselled a variety of national and local provider organizations, including the National Association of Specialty Pharmacies (NASP), Community Oncology Pharmacy Association (COPA), Community Oncology Alliance (COA), US Women’s Health Alliance, New York State Pain Society, and New Jersey Psychological Association (NJPA).
In addition to providing prospective regulatory guidance, Frier Levitt defends civil and criminal investigations and prosecutions at both the federal and state level. Frier Levitt has achieved dozens of successful outcomes for our clients, in both the investigatory and litigation stages, including many complex self-disclosure settlements with the Office of the Inspector General and False Claim Act resolutions. We aggressively defend with the goal of bringing about a favorable “global resolution’ at the earliest stage possible, one that addresses not only the underlying matter but also the potential collateral consequences to a professional license and career. Frier Levitt also manages or conducts corporate internal investigations when such a self-assessment is deemed to be in the best interests of our clients. Frier Levitt’s successful defense efforts have been bolstered by its team approach and the collaboration between its regulatory attorneys and members of its White Collar Criminal Defense and Government Investigations practice.