Harry Nelson

Practices

Government Investigations Litigation Regulatory Compliance Transactions

Harry Nelson, the Founder and Managing Partner of Nelson Hardiman, LLP, is one of the most respected healthcare lawyers in the United States. He is regularly sought out by leading healthcare and life-science institutions, as well as innovators, investors, and early-stage ventures, to advise on the most difficult issues in health regulatory strategy and compliance. Harry is also one of the most sought-after legal experts for media outlets seeking to understand the implications of our everchanging healthcare landscape.

As a result of his broad experience across three decades, Harry has become known as a problem-solver who is able to both counsel healthcare organizations on proactive strategy and manage through compliance and businesses crises. He serves as the outside general counsel for healthcare and life science organizations (including hospitals, behavioral health organizations, telehealth companies, and physician organizations) and also serves in board and expert witness. His expertise extends to healthcare and life science licensing, operational, and reimbursement risks and challenges.

Harry is the author of several healthcare policy books, including The United States of Opioids: A Prescription for Liberating a Nation in Pain (2019) From ObamaCare to TrumpCare: Why You Should Care (2017), and a forthcoming work addressing the revolution in healthcare privacy legal issues.

Accolades

Harry serves as chair of the Behavioral Health Association of Providers, an education and advocacy organization that works to advance standards and develop tools to address industry challenges. His leadership has been recognized, among other distinctions, by Behavioral Health Network Resources’ 2018 Addiction Advocacy Award. Since 2010, he appears annually on lists for Best Lawyers, Southern California Super Lawyers, and receives a Martindale-Hubbell AV Preeminent rating. The Best Lawyers in America (2021) recognized Harry for the the tenth consecutive year for his specialty in Healthcare Law, and for the first time, Harry was selected with a focus on COVID-19. The Daily Journal named Harry one of the Top Healthcare Lawyers in California in 2019. Harry also garnered the Behavioral Health Network’s Addiction Advocacy Award, the Davis Direction Foundation Award, and the CLARE | MATRIX Spirit Award in 2019.

Life Outside the Firm

Harry spends his time away from work advising nonprofits on leadership and change management. He has tried to teach his four children a love for Detroit sports teams and the University of Michigan.

Credentials

University of Michigan, J.D., cum laude

University of Michigan, A.B., with high distinction

State Bar of California

State Bar of Hawaii

State Bar of Illinois

Adaptive Business Leaders (Healthcare)

American Bar Association

American Health Lawyers Association

American Society of Addiction Medicine

California Academy of Attorneys for Healthcare Professionals

California Academy of Attorneys for Health Care Providers

California Society of Healthcare Attorneys

Los Angeles County Bar Association

Provisors Healthcare Roundtable

Wexner Heritage Program

Experience

Health System Outside Regulatory Counsel Serve as the resource for all regulatory compliance and risk management issues for California.
Behavioral Health Patient Safety Reforms/Compliance Following patient harm incidents, oversaw national addiction treatment organization with compliance program design, implementation, and extensive state-level certification and licensure.
Behavioral Health Compliance Oversaw development of standards and guidelines for providers and health plans on fraud and abuse issues, including waivers and discounts of patient financial responsibility and marketing activities
Behavioral Health Strategy Developed regulatory and reimbursement model for addiction treatment provider integration of medical and mental health professional services
Telehealth Compliance and Reimbursement Strategy Advised telehealth provider on compliance and risk management strategy in servicing Medicare beneficiaries and contracting with Medicare and in-network healthcare providers.
Asynchronous Telehealth Strategy Advised telehealth company on regulatory strategy for roll-out of asynchronous telehealth model, including development of relationships with state regulators, self-funded employer plans, and venture investors
FDA Lab Investigation Defended national clinical laboratory in FDA investigation and persuaded FDA to refrain from enforcement action based on corrective action plan and compliance program.
FDA Clinical Research Compliance Advised clinical research organization (CRO) on compliance in handling research related to cannabis and CBD.
FDA Biologic Products Compliance Prepared white paper on emerging issues in FDA regulatory pathways for stem cell therapeutics and other biologics
Retail Medicine-Corporate Practice of Medicine Served as expert witness in successful defense of corporate practice of medicine investigation of national chain of retail healthcare; Oversaw compliance program redesign and implementation
HIPAA Advised national physician specialty organization in developing a HIPAA-compliant patient data registry providing outcomes measurement and quality improvement.
HIPAA Served as expert witness on cases involving allegations of data breaches; advised multiple covered entities and business associates on HIPAA privacy and data security compliance and post-brief response strategy
Medicare Overpayment Represented medical group in a $3.1 million reduction in Medicare overpayment determination via contested hearing against recovery audit contractor.
Skilled Nursing Facilities Developed and implemented regulatory compliance programs for over 100 skilled nursing facilities (SNFs).
Stark/Anti-Kickback Statute Oversaw implementation of corporate integrity agreement on behalf of skilled nursing facility chain following federal investigation of Stark/Anti-Kickback Statute violations.
Fair Housing Rights Resolved disputes with five cities across California regarding complaints concerning behavioral health housing.
Sober Living Home Successfully defended a sober living home against City of Los Angeles criminal charges based on the mischaracterization of the home as an unlicensed community care facility and misapplication of the Los Angeles City Municipal Code. Nelson Hardiman convinced the City to drop all licensing and occupancy charges, and to dismiss its case against the sober living home and the property owner, thereby enabling the home to continue to house individuals recovering from addiction.

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Harry Nelson

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F: 310.203.2727

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