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.
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Nelson Hardiman focuses on healthcare providers regulated by the Food and Drug Administration (FDA) including pharmaceuticals, medical devices, nutritional supplements, health treatments and cures. As the go-to law firm for healthcare law, we deliver the ideal combination of regulatory experience and forward-thinking to advise clients on compliance with FDA issues specific to healthcare providers.
Our knowledge and experience with FDA regulations, compliance, and investigations protects providers wading into this vast and highly-regulated space. 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. We also provide counsel on investigations initiated by the Office of Criminal Investigations (OCI) which conducts criminal investigations under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) and Federal Anti-Tampering Act (FATA). Nelson Hardiman helps our healthcare provider clients resolve issues with the FDA and its agencies quickly, and on reasonable terms.
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Nelson Hardman fiercely protects healthcare providers from devastating allegations of healthcare fraud and abuse on a daily basis. We advise and defend, case-by-case, through victories and favorable resolutions, every facet of criminal investigations and charges, civil False Claims Act (FCA) fraud and abuse actions.
Few law firms can boast Nelson Hardiman’s experience in defending healthcare providers against allegations of fraud and abuse. Mark Hardiman, who leads Nelson Hardiman’s fraud and abuse practice area, is widely known among healthcare providers as the go-to defense lawyer for difficult and high-stakes Medicare and Medi-Cal fraud cases and is regarded as one of the most prominent fraud and abuse defense attorneys in California.
We have successfully represented countless individual physicians and healthcare facilities against fraud and abuse allegations in many of the leading cases filed in Southern California. And we have won significant victories at trial and on appeal and negotiated countless favorable settlements with federal and state regulatory agencies.
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Nelson Hardiman regularly advises clients on issues related to HIPAA, the Health Insurance Portability and Accountability Act. Our Los Angeles HIPAA lawyers assist clients by ensuring their compliance with security and privacy requirements for healthcare information. We regularly implement compliance plans particular to the business entity’s needs, from physician groups to long-term care facilities, as well as entities with unique legal privacy requirements and issues, such as mental health services agencies and drug treatment centers. When necessary, we defend investigations and enforcement actions relating to HIPAA violations. We have even been asked to advise governmental entities on unique issues such as the application of HIPAA and related state law to novel areas, such as medical marijuana dispensaries.
As a result of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act of February 2009, the scope of accountability for ensuring the privacy of protected health information (PHI) has extended beyond healthcare providers to their business associates, and even to the subcontractors of those business associates. Nelson Hardiman also advises on compliance with HIPAA Administrative Simplification Rules, including the Privacy and Security Rule. We advise clients on how to implement administrative, physical, and technical safefguards for electronic PHI (known as e-PHI) and we help develop and implement compliance plans consisting of policies and procedures and training of responsible personnel.
Although the term “HIPAA” has become synonymous with patient privacy, California healthcare providers need to be equally concerned with CMIA, the Confidentiality of Medical Information Act. Together, these two laws address not only patient privacy requirements, but also electronic standardization, security, and other requirements governing the handling and transmission of health information.
Federal and California law have significant differences in the area of patient privacy. With respect to coverage for example, HIPAA privacy and security rules apply to “covered entities,” which include healthcare providers who transmit healthcare information in electronic form (using a standard transaction), healthcare clearinghouses (e.g. billing companies), and health plans. CMIA, by contrast, has a far broader scope of coverage. In many areas, CMIA is actually more stringent than HIPAA in establish safeguards for patient privacy.
Nelson Hardiman counsels providers in determining whether they are HIPAA and CMIA compliant and in responding to allegations of noncompliance by state and federal regulators. We have assisted numerous providers with developing compliant notices and practices in their practices.
We also regularly respond to patient complaints concerning the handling of private information, and have defended lawsuits and administrative disciplinary actions involving these issues.