Harry Nelson

Practice Areas

Harry J. Nelson has built a record of respected authority on a broad range of healthcare compliance issues over the past three decades. He serves as outside general counsel to numerous healthcare organizations, including hospitals, behavioral health facilities, physician organizations, telemedicine companies, labs, pharmacies, and others, advising on healthcare licensing, business structuring, regulatory matters, and reimbursement compliance and strategy. He leads clients through risk identification, provides strategies and practical solutions for compliance, and regularly assists clients in managing crises in healthcare settings. He has delivered critical victories for providers, investor groups, and public companies in a series of hotly contested enforcement actions initiated by the Medical Board of California and the Board of Chiropractic Examiners related to corporate practice of medicine. Many crises have been averted by Harry’s able management and guidance.

Career

Harry is regularly called upon by healthcare providers and federal and state healthcare agencies to solve problems and address challenges both tactically and strategically. Beginning in 2015, the Medical Board of California asked Harry to teach Board personnel and experts on compliance issues ranging from corporate practice of medicine to prescribing. His work led to an adjunct clinical assistant professorship at the USC Keck School of Medicine, where he teaches and develops courses for physicians and health professionals on healthcare compliance, including prescribing and dispensing of medications. In 2017, Harry’s work in the area of medspas led the California Department of Consumer Affairs to appoint him to a task force to resolve policy questions relating to aesthetic and cosmetic medical devices. In the same year, he co-authored "From ObamaCare to TrumpCare: Why You Should Care," an analysis of the history and future of health policy. In 2018 and 2019, Harry served on various task forces with federal and state policymakers to address opioid crisis challenges, which led to his book, "The United States of Opioids: A Prescription for Liberating a Nation in Pain" (2019). Since 2016, Harry has provided California legislators with proposed legislative reforms to solve a series of practical industry problems, including AB 848 (establishing a pathway for medical care into addiction treatment) and AB 919 (authorizing standards for patient financial responsibility). His work led to the publication of a monograph on cost-sharing issues and the development of a curriculum to teach and certify healthcare marketers on compliance issues.

Publications

"United States of Opiods: A Prescription for Liberating a Nation in Pain" (2019); "From ObamaCare to TrumpCare: Why You Should Care" (co-author) (2017)

Expert in these Jurisdictions

California; Arizona; Texas; Pennsylvania; Illinois; Hawaii; New York

Work Highlights

Oversaw the organization of a national addiction treatment center, including compliance program design, implementation, and extensive state-level certification and licensure, following a number of patient harm incidents;

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;

Developed a regulatory and reimbursement model for addiction treatment provider integration of medical and mental health professional services;

Advised a telehealth provider on compliance and risk management strategies in servicing Medicare beneficiaries and contracting with Medicare and in-network healthcare providers;

Advised a telehealth company on regulatory strategy for roll-out of an asynchronous telehealth model, including development of relationships with state regulators, self-funded employer plans, and venture investors;

Defended a national clinical laboratory in an FDA investigation and persuaded the FDA to refrain from enforcement action, based on corrective action plan and compliance program;

Advised a clinical research organization (CRO) on compliance in handling research related to cannabis and CBD;

Prepared white papers on emerging issues in FDA regulatory pathways for stem cell therapeutics and other biologics;

Served as an expert witness in the successful defense of corporate practice of medicine investigation of a national chain of retail healthcare, subsequently overseeing redesign and implementation of their compliance program;

Advised national physician specialty organization in developing a HIPAA-compliant patient data registry, providing outcomes measurement and quality improvement;

Served as an expert witness on cases involving allegations of data breaches; advised multiple covered entities and business associates on HIPAA privacy and data security compliance, as well as a post-brief response strategy;

Represented medical group in a $3.1 million reduction in Medicare overpayment determination via a contested hearing against the recovery audit contractor;

Developed and implemented regulatory compliance programs for over 100 skilled nursing facilities;

Oversaw the implementation of a corporate integrity agreement on behalf of a skilled nursing facility chain, following the federal investigation of Stark Law and Anti-Kickback Statute violations;

Resolved disputes with five cities across California regarding complaints concerning behavioral health housing;

Successfully defended a sober living home against criminal charges brought by the City of Los Angeles, based on the mischaracterization of the home as an unlicensed community care facility and misapplication of the Los Angeles City Municipal Code. All licensing and occupancy charges were dropped, the case against the sober loving home was dismissed, and the property owner was thereby able to continue housing individuals recovering from addiction.