卫生保健执行
概述
Sidley has one of the most active Healthcare Enforcement practices in the world. We have represented numerous healthcare companies in well more than 100 criminal cases and civil enforcement actions over the years. Our clients on significant matters have included major manufacturers of drugs, devices and biotech products as well as providers of all types. Because our cases are often high profile matters of significant concern to our clients, we have extensive experience dealing with senior management and Boards of Directors.
详情
We represent clients in federal criminal and civil enforcement matters brought by Main Justice and by U.S. Attorneys' offices around the country - including Boston, Philadelphia, New York, California, Illinois, Texas and Florida. We work with clients on all aspects of enforcement matters, from search warrants to grand juries to ultimate resolution, on all major issues facing the industry. We have convinced a number of prosecutors to decline cases and have successfully resolved numerous others. On several occasions, we have negotiated “global” - i.e., federal and multi-state - settlements. We have also negotiated numerous Corporate Integrity Agreements.
In conjunction with our federal enforcement work, we litigate civil qui tam actions at both the district court and appellate levels. In such cases we have encountered virtually every issue that can arise - from jurisdictional issues to constitutional issues to intricate questions regarding causation, materiality, and falsity.
We have defended clients in enforcement actions brought by a number of states. In particular, we have experience representing clients in connection with multi-state consumer protection matters and multi-state Medicaid fraud matters.
We discreetly conduct internal investigations prompted by whistleblower complaints and internal audit findings. We advise clients on the full range of issues arising from such investigations, including self-disclosure, repayment obligations and human resource considerations.
We leverage our enforcement experience to advise healthcare companies on how to structure effective compliance programs that successfully identify and mitigate risk across the full range of issues most pressing to each client. We also offer practical advice to investors and purchasers on enforcement risk in the context of transactions, and assist with post-closing compliance remediation to address future enforcement risk.
We also have extensive experience representing both corporate clients and senior members of management in connection with Congressional investigations on a wide range of issues. Our lawyers have represented clients on all facets of such investigations, from informal requests for information through televised hearings before various committees.
Our enforcement team includes former senior Department of Justice officials, a former U.S. Attorney and several former Assistant U.S. Attorneys, Congressional staffers, and former White House and other Executive Branch officials, including the Department of Health and Human Services, with extensive enforcement experience.
Sectors
Representative Engagements
We have represented a broad array of drug, device and biotech companies in matters raising virtually every “hot” issue in the industry – including kickbacks, pricing, off-label promotion, “fraud on the FDA” or the Patent and Trademark Office, and Medicaid Rebates. We have a strong record of achieving declinations as well as a track record of important “firsts” – we negotiated the first major pricing settlement in the industry, the first major Corporate Integrity Agreement in the industry and the first FDA consent decree to involve substantive compliance obligations. Among other experience in this area:
- We have represented and continue to represent manufacturers in numerous investigations involving alleged kickbacks – in the form of patient assistance programs, prior authorization support programs, speaker programs, discounts, samples, grants, research support, and other arrangements. We also frequently lead internal investigations into allegations relating to these and other forms of alleged kickbacks.
- We have represented manufacturers in numerous government investigations alleging that violations of various federal statutes such as the Food, Drug and Cosmetic Act constitute violations of the False Claims Act. In particular, we have successfully represented and continue to represent major manufacturers in criminal and civil investigations involving alleged off-label promotion, risk minimization, and violations of current Good Manufacturing Practices regulations.
- We represent manufacturers in litigation with private parties and state Attorneys General relating to alleged violations of state unfair trade practices laws, including cases sounding in supposed violations of the Food, Drug and Cosmetic Act. For example, we represent a device manufacturer in a case alleging a violation of a state unfair trade practices law for failure to withdraw a device from the market.
- We have represented numerous clients in investigations relating to alleged violations of the Medicaid Rebate statute.
- We represented a major manufacturer in the first successful appeal of an AWP case. We successfully represented another major manufacturer in a settlement of allegations of Average Wholesale Price fraud involving the Department of Justice, the HHS Office of Inspector General and nearly every state. The settlement served as a template for negotiations by other manufacturers.
- We represented a major manufacturer in nationwide class actions alleging consumer fraud relating to the introduction of a new drug in the same therapeutic category as one of the manufacturer’s existing products.
- We represented major manufacturers in connection with House Oversight and Investigations Committee investigations into drug pricing and marketing issues.
- We have represented numerous manufacturers in connection with both Senate and House committee investigations into issues relating to Medicare Part D, Medicaid rebates, grants and other issues.
Representative Engagements
We have long represented providers of all types in major enforcement actions involving false billing, kickbacks, the Stark Law, the Beneficiary Inducement Statute, unnecessary services, and quality of care. Among other matters:
- We have represented numerous hospitals in connection with government investigations relating to billing and Anti-Kickback Statute issues and handled a number of OIG self-disclosures for such entities.
- We represented two national for-profit long-term care companies in connection with numerous criminal and civil investigations related to alleged kickbacks, billing fraud and quality of care issues.
- We represented the nation’s largest for-profit provider of psychiatric services in numerous criminal and civil investigations relating to alleged kickbacks to physicians, billing improprieties and quality of care.
- We represented a multi-state Medicare Advantage provider in a government investigation into alleged upcoding, resulting in the first provider-side resolution of such claims under the False Claims Act.
- We represented national retail pharmacy chains in civil and criminal investigations involving allegations of violations of under the Controlled Substances Act, pricing at above usual and customary charges, and other issues.
- We represented a hospital pharmacy in a civil and criminal investigation, resulting in the first Non-Prosecution Agreement entered into by a pharmacy to resolve alleged violations of the Controlled Substances Act.
- We represented a non-emergency medical transportation provider in a state Medicaid investigation into inflated billing.
- Conducted an internal investigation into alleged kickbacks relating to investment opportunities at ambulatory surgery centers.
- We represented one of the nation’s most prominent DME suppliers in connection with a variety of federal investigations relating to billing for DME supplies.
- Several lawyers in our group (prior to joining Sidley) represented a major dialysis provider in connection with what was (at the time) the largest healthcare fraud settlement as well as subsequent settlements with the U.S. Attorney’s Office in Boston.
