Healthcare Fraud and Abuse
The healthcare industry faces an ever-changing regulatory environment. Healthcare clients need experienced counsel skilled in navigating the complex laws and regulations to advise them on the legal issues facing healthcare providers every day. Haynes Boone lawyers regularly advise healthcare clients on fraud and abuse implications in existing and proposed arrangements under federal and state kickback and self-referral laws. Our aim is always to avoid preventable issues on the front end. But if a compliance issue does arise, Haynes Boone has a team of lawyers with decades of experience assisting healthcare providers with internal and government investigations in the healthcare industry, as well as advice related to self-disclosure and potential overpayment issues, administrative proceedings, and civil and criminal enforcement actions related to healthcare fraud and abuse issues.
Regulatory Matters
Haynes Boone excels in advising clients on compliance with federal and state healthcare regulations, including the Anti-Kickback Statute, the Stark Law, and the False Claims Act, among others. We provide front-end regulatory guidance and also assist healthcare providers, pharmaceutical companies, medical device manufacturers, and other healthcare entities in developing and implementing robust compliance programs to mitigate the risk of potential violations.
Investigations
Haynes Boone has extensive experience conducting internal investigations for healthcare clients. Our team works diligently to uncover the facts, assess potential legal and regulatory issues, and develop remediation strategies. We also represent clients in government investigations conducted by agencies such as the Department of Justice (DOJ), the Office of Inspector General (OIG), and the Centers for Medicare & Medicaid Services (CMS) and State Attorneys General.
Self-Disclosure
Our attorneys also guide clients through the self-disclosure process in the event potential issues are identified, advising on whether and when to voluntarily report potential issues to the appropriate regulatory authority. We assist in preparing self-disclosure submissions, negotiating settlements, and ensuring that clients take the necessary corrective actions to prevent future violations.
Pre-Litigation Representation
Haynes Boone is adept at representing clients in pre-litigation matters, including responding to subpoenas, civil investigative demands, and other inquiries. We work to resolve issues before they escalate to litigation, protecting our clients' interests and minimizing potential disruptions to their operations.
Other Related Matters
Haynes Boone’s Healthcare Fraud and Abuse team also provides counsel to healthcare providers on a variety of other matters that uniquely affect healthcare clients. These include advising on corporate transactions, conducting due diligence, and providing training on fraud and abuse prevention. Our team-driven approach ensures that clients receive comprehensive support tailored to their specific needs from our bench of former in-house lawyers, former government lawyers, and specialized healthcare defense counsel.
- Following significant litigation with the U.S. Attorney’s Office for the Southern District of Texas, successfully had felony HIPAA charges dismissed with prejudice on behalf of a whistleblower in Houston.
- Represented one of the nation’s largest healthcare providers in an internal investigation of allegations of potential submission of false claims in the cardiac catheterizations laboratory. The investigation included a review of medical records to analyze quality of care issues. Advised client on voluntary disclosure issues.
- Ongoing representation of one of the nation’s largest nonprofit healthcare providers in multiple internal investigations regarding multiple whistleblower complaints fielded through the company’s compliance hotline.
- We are the lead regulatory counsel for a publicly traded biopharmaceutical company that develops inhaled therapeutics. We are advising them on healthcare regulatory matters, including clinical research, data privacy obligations, and patient informed consent matters.
- We represent a publicly traded medical device company with products distributed in over 60 countries. We regularly assist in-house compliance and legal team with navigating highly complex healthcare regulatory and transactional matters and developing organization-wide policies and processes to comply with these regulations. We provide ongoing healthcare regulatory advice on areas including the federal Anti-Kickback Statute and similar state laws; the Stark law; billing and repayment obligations; HIPAA and data privacy; and other regulatory and transactional issues.
- On behalf of a healthcare company and its president and chief executive officer, navigated a complex, multi-year investigation by the Internal Revenue Service – Criminal Investigation Division and the Department of Labor Office of Inspector General into allegations of fraud relating to insurance products, resulting in no charges.
- Successful defense of a bariatric surgeon in multiple investigations and prosecutions by the U.S. Attorney’s Office for the Northern District of Texas.
- Provide ongoing regulatory guidance to a hospital authority including analyzing potential financial relationships with physicians, hospitals, and other healthcare providers for compliance with the federal Anti-Kickback Statute and Stark Law and advise the board regarding healthcare regulatory considerations related to such potential financial relationships.
- Secured a favorable result for one of the nation’s largest healthcare providers in a voluntary disclosure related to on-call arrangements.
All cases vary and none are predictive.