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.

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