When it comes to government investigations in the healthcare industry, we know the landscape better than anyone. For more than 20 years, our lawyers have focused on regulatory compliance and government investigations specific to the healthcare industry. Nelson Hardiman’s government investigations practice combines on-point government experience, in-depth understanding of the complex regulations and underlying issues driving healthcare policy, and a sensitivity to the critical nature of these issues.
We advise national and local healthcare providers on criminal investigations and charges, civil False Claims Act (FCA) and fraud lawsuits, administrative overpayment and disciplinary proceedings, and regulatory compliance issues, including internal investigations, voluntary disclosures of possible FCA violations, the federal anti-kickback statute and the Stark Law. Our unparalleled experience in government investigations gives us the ability to navigate critical and costly legal problems that threaten providers foundational to the healthcare industry.
DEA compliance is key for healthcare providers who prescribe and dispense Controlled Substances (Schedules II through V). Our attorneys are trailblazers at the forefront of the battle against opioid abuse and recognized authorities in DEA compliance. Creators of industry-respected program integrity guidelines to ensure regulatory compliance, Nelson Hardiman works with clients to address DEA audits and compliance actions and assists clients in ensuring strict compliance with DEA requirements.
Nelson Hardiman attorneys leverage decades of government enforcement experience to represent healthcare providers during investigations, audits, and administrative actions by the federal Drug Enforcement Administration (DEA). We help clients understand federal (DEA) and state (California Bureau of Narcotics Enforcement, BNE) regulatory compliance requirements and avoid the risks of monetary penalties, loss of DEA certification, licensing actions, or even criminal sanctions. Nelson Hardiman works with healthcare providers to ensure DEA compliance proactively and in response to DEA actions.
Nelson Hardiman defends healthcare and life sciences clients in FDA investigations. We leverage powerful experience in government investigations and regulatory policy to run interference on a wide range of issues involving accusations of data corruption, illicit business referrals, medical device and drug safety issues, including investigations and enforcement actions related to the opioid crisis.
Recognized leaders in the regulatory arena, our experienced litigators and trial lawyers protect healthcare industry organizations facing challenging situations with the FDA. We advise on warning letters, investigations and enforcement actions against healthcare providers and their operations, including False Claims Act charges or criminal sanctions for violation of FDA laws. Nelson Hardiman helps our healthcare clients resolve issues with the FDA and its agencies quickly, and on reasonable terms, with a commitment to strategic business goals and commonsense solutions.
No one defends healthcare providers against allegations of healthcare fraud and abuse better than Nelson Hardiman. The increasing size, scope, and aggressiveness of recent fraud investigations and prosecutions by the federal government, the State of California and private health insurers makes the need for experienced and sound counsel greater than ever.
We have defended countless fraud and abuse investigations. We are widely regarded as one of the most prominent fraud and abuse law firms in California, a reputation earned representing health care providers on all facets of criminal investigations and charges, civil False Claims Act (FCA) and fraud allegations, and administrative proceedings.
Our exemplary track record testifies to our keen knowledge and experience of healthcare compliance issues, including Medicare, Medi-Cal, and private insurance coverage. We develop compliance programs that minimize the risk of fraud and abuse investigations, counsel health care providers on how to avoid allegations, and how to respond when they arise, making us the go-to law firm to handle fraud and abuse investigations.
Our outstanding team of healthcare attorneys leverage their comprehensive understanding of HIPAA, The Health Insurance Portability and Accountability Act, to ensure compliance with security and privacy requirements for healthcare information. Healthcare providers of all stripes rely on Nelson Hardiman to implement compliance plans and to defend investigations and enforcement actions relating to HIPAA violations.
Related federal and state privacy and security requirements can quickly become complex, and we’ve handled them all. We advise on compliance with HIPAA Administrative Simplification Rules. We ensure compliance the Health Information Technology for Economic and Clinical Health ACT (HITECH). We counsel California providers to ensure they are HIPAA and Confidentiality of Medical Information Act (CMIA) compliant. We respond to patient complaints, and defend lawsuits and administrative disciplinary actions. When it comes to HIPAA and related laws addressing patient privacy and the transmission of health information, Nelson Hardiman has the knowledge and experience to meet every challenge.