Health & Life Sciences

Fraud & Abuse Compliance and Litigation

Quarles & Brady’s Fraud & Abuse Compliance and Litigation Team knows the health care industry is steeped in a myriad of laws, rules, and regulations that can confuse and trip up even the most well-intentioned organizations. As the regulatory landscape changes, organizations must proactively adapt to comply with new mandates and avoid missteps that can damage the bottom line.

Our attorneys understand these challenges and guide clients through the compliance process to identify issues before they become problems. Our client base includes organizations from nearly every health care sector, including:

  • Hospitals and health systems
  • Pharmaceutical
  • Medical technology and device manufacturers and distributors
  • Retail and wholesale pharmacies
  • Durable medical equipment suppliers
  • Physician clinics
  • Long-term care facilities
  • Home health agencies

This diverse client base gives us a unique perspective on the health and life sciences industry and allows us to bring a specialized understanding of the trends and forces affecting our clients’ businesses to our work.

Our team's diverse background includes former high-level government officials, former federal and state prosecutors, former agency lawyers from the Office of the Inspector General (OIG), the Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA), industry experts, and lawyers with real world practice experience from pharmacy, nursing, and occupational and physical therapy worlds. Our deep bench of attorneys allows us to counsel clients through a 360-degree representation strategy by providing firsthand industry experience and an "insider's" view on risk identification, regulatory compliance, and liability mitigation.

We analyze issues from the government's perspective, because our lawyers have shaped agencies and have been at the forefront of some of the government's largest enforcement actions and compliance initiatives. In the event an enforcement matter does arise, our litigation team uses its experience to defend companies before federal and state courts across the criminal, civil, and administrative enforcement spectrum.

Services

Our highly regarded team provides a wide variety of services throughout the United States, including:

  • Reviewing contracts and financial arrangements to ensure compliance with applicable fraud and abuse laws
  • Issuing legal opinions on arrangements or transactions
  • Defending False Claims Act investigations and litigation, including violations of the Anti-Kickback Statute and the physician self-referral law (Stark Law)
  • Conducting internal or parallel investigations
  • Advising on government audits
  • Defending administrative enforcement proceedings brought by the OIG under the Civil Monetary Penalties Law or program exclusions law before the Departmental Appeals Board
  • Overseeing document production in response to subpoenas or civil investigative demands
  • Advising on investigations conducted by the Department of Justice (DOJ), the OIG, or the DEA regarding regulatory non-compliance
  • Assisting clients in self-disclosing regulatory violations through the OIG's self-disclosure program
  • Defining individuals and entities in professional liability and licensing proceedings
  • Appealing overpayment determinations
  • Developing and implementing corporate compliance programs
  • Negotiating corporate integrity agreements, or assisting in preparing annual reports for individuals or entities under integrity agreements, with the OIG
  • Responding to government or third-party payor audits
  • Petitioning the Centers for Medicare & Medicaid Services (CMS), the OIG, the DEA, and the FDA for rulemaking or comment on proposed rules
  • Counseling on HIPAA and data breaches