医療分野強制執行

Sidley has a world-renowned Healthcare Enforcement practice and regularly counsels providers, manufacturers, hospital systems, life sciences companies, and investors in enforcement defense and strategy. Healthcare and life science companies must comply with complex and frequently changing regulations and face heavy government scrutiny, both in the United States and globally. As a result, industry actors often find themselves called to respond to a civil or criminal government inquiry. Increasingly, companies that are not directly involved in patient care or manufacturing healthcare products find themselves also facing such scrutiny, even if the company remains one step removed.

Sidley’s Healthcare Enforcement practice has decades of experience in counseling clients in enforcement-related capacities including: responding to Civil Investigative Demand letters or subpoenas; conducting privileged internal investigations; building and implementing effective compliance programs; overseeing the execution of Corporate Integrity Agreements; determining the appropriate corrective actions when necessary; and to testifying in front of government bodies. Because Sidley often handles high profile matters of significant concern to our clients and Sidley’s Healthcare team has extensive experience in dealing with senior management and Boards of Directors.

Federal Enforcement Matters: 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. These enforcement matters often evaluate alleged violations including but not limited to the following laws:

• The False Claims Act
• The Anti-Kickback Statute
• The Stark Law
• Beneficiary Inducement Statute
• Medicare and Medicaid reimbursement rules
• Patent or Trademark law
• Federal Food, Drug and Cosmetics Act, including “fraud on the FDA” theories

We work with clients on all aspects of enforcement matters. In the civil context this can include negotiating the scope of discovery, conducting a parallel internal investigation, making productions, and meeting with the government to make a presentation to seek a declination. In the criminal context this can also include responding to search warrants and appearing in front of grand juries.

In all matters Sidley advises our clients on the best possible resolution. 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, our team has experience litigating civil qui tam actions at both the district court and appellate levels. Our global practice ensures that we have encountered virtually every issue that can arise — from jurisdictional issues to constitutional issues to intricate questions regarding causation, materiality, and falsity. Sidley’s Healthcare Enforcement team successfully represented Novo Nordisk Inc. in securing the first defense verdict for a pharmaceutical company ever in a False Claims Act jury trial. Not only was this the first-ever jury verdict in favor of a defendant pharmaceutical company, but the unanimous jury verdict arrived in only four hours after a three-week trial.

State Enforcement Matters: Sidley also defends 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. In other instances, Sidley works alongside local counsel in responding to state-issued subpoenas. These investigations often seek information to evaluate alleged violations including but not limited to the following laws:

• State False Claims Act
• State Anti-Kickback laws
• Medicaid Fraud
• Consumer Protection Law
• Insurance and billing fraud

Internal Investigations: 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.

Compliance Oversight: Sidley leverages our enforcement experience to advise companies on how to structure effective healthcare compliance programs that successfully identify and mitigate risk across the full range of issues most pressing to each client. Sidley has advised companies on the implementation and execution of compliance programs subject to the requirements of a Corporate Integrity Agreement.

Enforcement Diligence: In deals where companies are considering purchasing or lending to a healthcare company, Sidley’s robust enforcement experience allows us to offer practical advice to investors, purchasers, or lenders on the assessment of the enforcement risk in the context of transaction. Sidley also assists with post-closing compliance remediation to address future enforcement risk.

Congressional Investigations: 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. Sidley has represented clients on all facets of such investigations, from informal requests for information through televised hearings before various committees.

Our enforcement team includes lawyers with extensive enforcement experience, including multiple 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.

Sidley represents a broad array of healthcare and life science companies, including: biotech and pharmaceutical companies; medical device manufacturers; hospitals; pharmacy chains; health plans; physician staffing companies; dialysis services; and laboratories. Sidley also represents companies that may not actually provide healthcare or manufacture healthcare products, but that still must comply with healthcare laws and may find themselves responding to a government enforcement action or needing advice on how to assess the risk in instances, such as, revenue cycle management, waste management, patient assistance, or electronic health records, and private equity investors and financial service companies.

Sidley has a strong record of achieving declinations in enforcement investigations and has obtained many important “firsts” — including negotiating 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 experiences in this area:

• Representation of clients, including pharmaceutical companies, healthcare providers, and provider management service companies, in Department of Justice (DOJ) False Claims Act investigations, including:
  • Numerous hospitals in connection with government investigations related to allegations regarding billing and Anti-Kickback Statute violations.
  • Two 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.
  • 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.
  • Pharmaceutical companies on allegations related to promotional speaker programs, off-label promotion, kickbacks, and price reporting.
• Pharmaceutical and biotech clients in government investigations alleging that violations of various federal statutes, such as the Food, Drug and Cosmetic Act, constitute violations of the False Claims Act.
• A private equity fund in a DOJ False Claims Act investigation focused on whether it can be liable for causing the submission of false claims by providers in connection with the sale of medical devices by a portfolio company.
• Pharmaceutical companies in parallel criminal and civil investigations by the DOJ’s Consumer Protection Branch and Civil Fraud Section and the U.S. Attorney’s Office for alleged fraud on the FDA and Patent and Trademark Office as a predicate to FCA liability.
• A pharmaceutical company distributor in a criminal investigation brought by the DOJ’s Consumer Protection Branch and the U.S. Attorney’s Office for the Western District of Virginia concerning misbranding of veterinary prescription drugs under the Food, Drug and Cosmetic Act and violations of the Controlled Substances Act.
• A pharmaceutical company in collective proceedings in the English High Court brought in parallel to a U.S. class action regarding the same allegations of product liability.
• Clients in investigations relating to alleged violations of the Medicaid Rebate statute.
• 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.
• National retail pharmacy chains in civil and criminal investigations involving allegations of violations under the Controlled Substances Act, pricing at above usual and customary charges, and other issues.
• 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.
• A non-emergency medical transportation provider in a state Medicaid investigation into inflated billing.
• Companies in conducting internal investigation into alleged kickbacks relating to investment opportunities at ambulatory surgery centers.
• Major manufacturers in connection with House Oversight and Investigations Committee investigations into drug pricing and marketing issues.
• Numerous manufacturers in connection with both Senate and House committee investigations into issues relating to Medicare Part D, Medicaid rebates, grants, and other issues.
• 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.