Regulatory Compliance

Nelson Hardiman advises 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 and compliance protects providers wading into this vast and highly-regulated space. We counsel on every aspect of FDA regulations, concerning the safety of drugs, medical devices, food, cosmetics and other health-related products. Our singular focus and industry experience in healthcare and life sciences laws and regulations protects our clients from the threat of FDA investigations, and puts them ahead of the competition.

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.

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.

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.

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.

Nelson Hardiman is proud of its expertise and reputation in the highly dynamic field of telehealth, including being on a short list of the leading law firms in the country with the specialized knowledge and experience to structure, operationalize, and support the growth of telehealth ventures. We are proud of our experience of taking telehealth ventures from the “whiteboard” phase of planning through early stage growth through the entire venture life cycle, including Series A, B, and later funding rounds, public company or private equity acquisition and even going public. While we are true experts in compliance for telemedicine and other telehealth ventures, we offer clients a distinctive level of telehealth regulatory strategy on the pathway necessary for growth and success.

Our experience includes counseling telehealth pioneers, such as Teladoc, Amwell, as well as cutting edge telehealth companies like Lemonaid Health, and mixed telehealth and brick-and-mortar providers like Carbon Health. Teledentistry companies like Byte have relied upon Nelson Hardiman to take them from early stage concept and start-up all the way to acquisition. Many of the most well known brands in telehealth and subspecialties, including telebehavioral health ventures and focused telemedicine modalities have relied upon our unrivalled experience navigating regulatory issues integral to telehealth. We represent telemedical and other telehealth companies from startup to publicly traded companies, and also advise existing brick-and-mortar and institutional providers on regulatory strategy, compliance, and build-out of telehealth services.

Across the nation, telehealth is rapidly evolving and providers must stay current with distinct areas of relevant law, including corporate practice of medicine compliance (including the PC-MSO model), privacy and data security compliance, an understanding of the laws governing distinct modalities of telehealth, supervision, and scope of practice issues, and pharmacy regulatory issues. Few firms combine the depth in both understanding the regulations, agency guidance, and enforcement priorities. The majority of big law firms that claim to provide telehealth expertise are sorely thin on direct experience addressing challenges with state regulators, an area where Nelson Hardiman’s track record of crisis resolution has been invaluable. (It is little surprise that we are routinely brought in as regulatory counsel on telehealth projects by the largest law firms in the country.) Our experience is often the difference maker at all stages in the venture, allowing clients to move quickly while other firms are busy researching issues with which we are already fluent.

The combination of a deep understanding of the telehealth regulatory landscape, enforcement activity and priorities, and what compliance needs to look like throughout the growth of a venture make Nelson Hardiman a compelling choice for telehealth providers. Nelson Hardiman Harry Nelson has been called upon to advise state regulators in evaluating disciplinary issues for health professionals in noncompliant ventures. Although general guidelines have been recommended and there is interest in moving towards national telehealth standards, the legal and regulatory challenges associated with telehealth today typically are highly dynamic across state lines. It is vital to retain experienced counsel in the event of any licensing board accusations or investigations.

Nelson Hardiman has taken dozens of telehealth providers from their starting steps to exit, and is known for its depth of experience in accomplishing its clients’ goals. Whether you are in the planning phases of a telehealth venture or other mobile telehealth platform or looking for new options to provide efficient, on-the-money answers to the most difficult questions, Nelson Hardiman can provide the detailed, proactive counseling and representation necessary to meet your particular business, regulatory, and strategic challenges. Our services span the range of telehealth issues and include, for example: