What We Do

Attune to the key issues and emerging trends impacting the healthcare industry, Nelson Hardiman’s healthcare lawyers 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.

Our Work Includes:

• Data Security Regulation Advised on the regulation of data security practices under the FTC Act and California unfair competition law.
• Data Security Requirements Advised a telehealth entity on the state law requirements governing patient identity verification.
• HIPAA/Privacy and Information Security Counseled providers, clinical trials companies, ancillary providers, technology start-ups, HMOs, insurance companies and others on HIPAA and state health information privacy laws and development of privacy compliance programs.
• Program Development Structured joint patient assistance program to address health information privacy and security requirements.

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.

Our Work Includes:

• Cosmeceutical Products Counseled several clients on compliance with the federal Food, Drug, and Cosmetic Act requirements with respect to manufacturing, sale, and marketing of cosmeceutical products.
• Dialysis Center Advised on compliance with FDA regulations specific to ESRD (dialysis centers) and responded to an investigation of a dialysis center.
• Institutional Review Board (IRB) Advised on compliance regarding scientific research involving human research subjects and responded to research investigations.
• Mammography Counseled on compliance with FDA regulations specific to mammography.
• Off-Label Drug and Medical Devices Counseled clients on “off label” use of drugs and devices.

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.

Our Work Includes:

• Boards of Directors Advised board of directors on fiduciary obligations and governance.
• Governance Formed over five hundred entities, corporations of all types, LLCs, PLLCs, LPs, trusts, and non-profits, together with governance documents to support regular business operations, financing, and mergers.
• Regulatory Compliance Advised numerous Southern California hospitals and medical staffs on governance issues, including drafting and revising hospital governing bylaws. Thought Leadership Co-Founder and Managing Partner Harry Nelson is a frequent speaker about leadership and board governance issues, and has worked with nonprofits on their organizational development and strategy.
• Transactions Over three decades of transactional experience in New York and California handling finance, mergers and acquisitions, antitrust advisory, regulatory and corporate governance matters for healthcare organizations and corporate entities.

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.

Our Work Includes:

• Administrative Proceedings Advised healthcare providers in Medi-Cal administrative appeals and related judicial proceedings.
• Business/Operational Procedures Modified provider business plans and implemented new policies and procedures to comply with Medi-Cal regulations.
• California Medical Board Prevailed on a motion for review of Board records, resulting in dismissal of a case against a physician accused of criminal Medi-Cal fraud.
• Enrollment Successfully appealed denial of Medi-Cal provider enrollment application for medical professionals.
• Factoring Advise Medi-Cal providers on healthcare factoring to gain access to capital to fund ongoing business.
• Litigation Overturned wrongful Medi-Cal suspension of medical practitioner based on criminal conviction.
• Regulatory Compliance Represented university medical center in a petition to overturn a Medi-Cal audit decision by the Department of Health Care Services (DHCS).

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.

Our Work Includes:

• Audit Appealed a Medicare audit that had been “lost” in the system, depriving the provider of the opportunity to contest overpayment findings. We sued the contractor and CMS to compel the reinstatement of the appeal and successfully defend the provider before the Office of Medicare Hearing Appeals (OMHA).
• Fraud and Abuse Persuaded Medicare to abandon a $800,000 overpayment demand against a physician based on his disclosure of fraud and abuse by a clinic manager.
• Medicare Advantage Ran a Medicare Advantage program for a hospital and negotiated new contracts with Medicare Advantage plans on behalf of an IPA.
• Office of Medicare Hearing Appeals (OMHA) Represented a multi-office medical group for alleged overpayment of $5.6 million in diagnostic testing, office visits, and other services. Appeal to OMHA reduced the overpayment to $80,000, a reduction of over 98.6%.
• Provider Underpayment Represented a hospital in litigation and settled with a national Medicare supplement insurer and its associated endorsing agent over underpaid provider claims.
• Reimbursement Represented a physician who provided intravenous immunoglobulin (IVIG), a treatment for autoimmune diseases. When the contractor contended that the patients failed to meet the Medicare-established criteria for IVIG, we demonstrated medical necessity resulted in overturning of all but $300 of the $1.4 million claim.

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.

Our Work Includes:

• California Board of Pharmacy Negotiated settlement of disciplinary action for a medical device wholesaler.
• California Department of Healthcare Services Appealed audit findings of the California Department of Healthcare Services on behalf of a pharmacy.
• California Medical Board Obtained a complete withdrawal of Board accusation against an out-of-state physician affiliated with the nation’s largest telehealth provider.
• Corporate Practice of Medicine Advised on corporate practice of medicine requirements in structuring business and financial relationships between health professionals, entrepreneurs, and investors.
• ERISA Compliance Represented out-of-network hospital in litigation against Blue Cross and ERISA plan for violating a provision of the California Knox-Keene Act by failing to pay for emergency services treatment provided to a Blue Cross member.
• Healthcare Factoring Structured factoring transaction for six health care providers and three investment firms involving $20 million in workers’ compensation accounts receivable in response to changes brought forth by California Senate Bill 1160.
• Knox Keene Act Prevailed on discovery dispute and obtained $4,500 in sanctions, leading to dismissal of a California Knox-Keene Act complaint brought by a serial plaintiff physician.
• Whistleblower Counseled a physician in a dispute with a hospital concerning the suspension of his privileges. The physician sued as a whistleblower under California Health & Safety Code section 1278.5 and for discrimination in violation of the California Unruh Civil Rights Act.

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:

• Regulatory Strategy – analyzing risks and opportunities, risk strategy, and growth strategy, including new models of care, emerging modalities, evolving standards, and guiding clients in charting their venture pathway;
• Regulatory Compliance – guiding clients on corporate practice of medicine, privacy/data security (HIPAA, CCPA), standards of care, modalities of telehealth, FDA requirements, licensing, internet prescribing, Stark and Anti-Kickback, physician oversight, scope of practice and supervision, and other compliance issues, including development of compliance workplans and infrastructure;
• Regulatory Diligence – navigating the acquisition or funding process, including providing support as needed to address concerns of acquirers, funders, and strategic partners of telehealth ventures, as well as providing regulatory counsel on mergers and acquisitions in support of “deal counsel”;
• Corporate and Business Transactions – early stage corporate formation and structuring of professional corporations, management service organizations (MSOs), guidance on establishing compliant models, and documentation of transactions;
• Regulatory Defense – response to Medical Board, Pharmacy Board, FDA, and other regulatory investigations, proactive outreach to regulators, and response to emergent crises relating to telehealth ventures;;
• Litigation – disputes related to telehealth, including government investigations, enforcement actions, and litigation (e.g. False Claims Act/qui tam whistleblower litigation and general business disputes).

For more information or to speak with an attorney, please call 877.246.6423 or submit a contact form: