Healthcare today is regulated by an “alphabet soup” of agencies enforcing an endless list of laws and regulations. We make it our business to understand state-specific requirements and federal Medicare, DEA, FDA, HIPAA and other regulatory issues. We tackle the most complex emerging issues in healthcare and life sciences regulatory compliance today, based on our involvement at a strategic and granular level in virtually every facet of the healthcare industry.
We have defended healthcare providers in investigations and actions before the widest range of federal and California state regulatory agencies. We combine specialized experience in a wide range of healthcare sectors with a proactive and attentive approach, making us the go-to law firm for healthcare regulatory matters. Clients hire us because we navigate the ever-evolving California and federal healthcare laws and regulations with the integrity, experience and insight healthcare providers cannot live without.
Attune to the key issues and emerging trends impacting the healthcare industry, Nelson Hardiman’s healthcare attorneys are adept at managing the data privacy and security concerns that drive the way information is created, stored, and utilized. Hospitals, health systems, healthcare companies and individuals rely on us to navigate regulatory compliance standards and advise on best practices to mitigate risk in an industry impacted by security breaches and emerging healthcare technologies.
Nelson Hardiman combines strategic vision with practical advice to advise on the data privacy and security issues around the collection, analysis, use and disclosure of patient information and related data that is driving success in the healthcare industry.
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Nelson Hardiman advises clients on compliance with Food and Drug Administration (FDA) issues specific to healthcare providers.
Many providers are unaware of the extent to which the FDA regulates medical and healthcare practice. In recent years, the FDA has become increasingly active and, in addition to issuing warning letters threatening immediate corrective action or other regulatory enforcement, is often investigating and taking more severe enforcement actions against healthcare providers and their operations, often pressing False Claims Act charges or seeking stiff criminal sanctions for even unintentional violation of FDA laws.
The Office of Criminal Investigations (OCI) is the law enforcement arm of the FDA, and was established for the purposes of conduct and coordinating criminal investigations under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) and Federal Anti-Tampering Act (FATA). According to the FDA, OCI investigations are bad news for providers because they are not routine but rather concentrate on “significant violations of these laws, with a priority on conduct that may present a danger to the public health.” The OCI is particularly keen on investigating: (1) false statements to the FDA during the regulatory process, (2) failures of legitimate medical supply chains via unapproved, counterfeit, and substandard medical products, and (3) situations where the typical compliance and regulatory process has failed to resolve the problem and/or where there is a particularly high risk of public harm. Although the purview of the FDA is extremely broad, investigations of healthcare providers are typically focused on:
Nelson Hardiman’s knowledge and experience with FDA regulations, regulatory compliance, and investigations is vital for providers wading into this highly-regulated space, and is particular effective when engaged early in the process. Often, investigations are initiated in response to innocent mistakes or inadvertent compliance issues by healthcare providers or their staff. Competent representation can often help resolve issues with the FDA quickly, and on reasonable terms. Nelson Hardiman’s timely involvement in these cases can be particularly instrumental, especially in those situations where a failure to convincingly respond to the FDA’s probe may be viewed as obstructive and/or lead to much more formal enforcement action, including criminal investigation and prosecution. Nelson Hardiman’s industry experience includes:
The seismic changes impacting the healthcare industry place increasing burdens of care on the governing boards of hospitals and health systems. Nelson Hardiman partner Rob Fuller harnesses his deep experience in corporate governance as a former hospital COO to lead our transactional team and advise on challenges in a transformed healthcare environment. When healthcare organizations need the guidance and advocacy that comes with deep integrity and experience, they turn to Nelson Hardiman.
We understand the unique business structures of the healthcare sector and the legal requirements of corporate governance. Nelson Hardiman leverages our national reputation for business expertise to ensure that boards, directors, trustees and management teams meet the fiduciary obligations and governance challenges of the evolving healthcare industry.
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Nelson Hardiman navigates Medi-Cal’s complex regulatory landscape with the fortitude and determination of seasoned healthcare attorneys. We have advised some of the largest hospitals and health systems on cases that involved audits, appeals, allegations of fraud and abuse, reimbursement issues and overpayment disputes. Because of our deep experience and our role as industry leaders, we are uniquely qualified to advise healthcare providers large and small on the challenges and opportunities of participation in the Medi-Cal program.
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Nelson Hardiman is a recognized leader in advising and defending Medicare providers in California. For an industry focused on regulatory compliance, we tackle the full range of Medicare-related issues head-on. As Medicare increasingly seeks to contain the rising costs of healthcare in the face of a federal crackdown on Medicare abuse, we help healthcare providers justify the medical necessity of the services they provide and protect physicians from accusations of overpayment and fraud.
Our team of Medicare lawyers develop compliance programs, provide audit assessments, and defend providers who experience problems with their participation in the Medicare program. From enrollment issues to recovery audits, we resolve complex Medicare issues and counsel on Medicare compliance, including Medicare Secondary Payor (MSP) issues. We defend healthcare providers in Medicare Part B recovery audits and appeals. We defend providers from claims by private health plans and payor auditors who pursue reimbursement refunds based on patient Medicare coverage. Whatever the Medicare challenge, Nelson Hardiman has the legal knowledge and experience to navigate the complex landscape of regulatory compliance on behalf of healthcare providers.
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From its base in Southern California, Nelson Hardiman leverages our extensive knowledge of California healthcare laws to advise national and California-based hospitals, health systems and other healthcare providers statewide. The firm’s Los Angeles office gives Nelson Hardiman a strong local presence while operating on a national level.
Our healthcare attorneys provide unmatched legal counsel on all areas of California law and regulations affecting healthcare, including California-specific requirements such as the corporate practice of medicine and the Knox-Keene Act. Recognized for our premiere, cutting-edge healthcare experience, we deliver a formidable combination of strategic thinking and litigation and transactional know-how, frequently working with state and local government to shape the path of healthcare law in California.
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