Addiction and Recovery
Nelson Hardiman champions compliance standards for addiction and recovery treatment providers. We led the launch of the Behavioral Health Association of Providers to establish guidelines for addiction and recovery professionals to operate ethically and comply with industry standards. We guide addiction treatment providers through regulatory and reimbursement challenges and make sure our clients stay on top of the ever-changing standards impacting the industry.
In 2021, a record 100,000 Americans lost their lives due to drug overdoses, including heroin, fentanyl analogs, and prescription medications. We are proud of our track record as the leading firm in the United States advising on complex and evolving issues facing addiction and recovery treatment centers, group homes, and sober living facilities. In 2016, […]
Aesthetic Medicine/Beauty/Medical Spas
Nelson Hardiman has been a long-time adviser to the aesthetics industry, including plastic surgeons, cosmetic dermatologists, medspas, and cosmetic product developers and device-makers. The firm played a central role in the development of content for the American Med Spa Association, and has been consulted by state regulators to provide input on emerging risk and enforcement […]
Alternative Medicine Providers
Deeply immersed in an industry at the forefront of regulation, innovation and consolidation, Nelson Hardiman has a firm grasp on the changing landscape for complementary and alternative medicine providers (CAMs), who are leading the way in integrative treatment options.
Ambulance / Medical Transport
Nelson Hardiman is driven to solve the toughest challenges of ambulance and medical transport industry-wide. We harness our in-depth knowledge of healthcare law to represent California ambulance companies and other medical transportation businesses, including wheelchair and stretcher van companies.
Ambulatory Surgery Centers
Nelson Hardiman is a proud strategic partner for industry-leading ambulatory surgery centers (ASCs). We understand the unique challenges facing ASCs, having actively navigated through every phase of an ASC’s life cycle. With surgeons’ services being reimbursed at ever-lower rates by Medicare and insurers, we know it is essential to develop ambulatory surgery centers as successful profits centers essential to the future of the healthcare industry.
Assisted Living Facilities
Nelson Hardiman applies a wealth of experience to the issues surrounding aging in America to counsel residential care facilities for the elderly (RCFEs), the fastest growing component of long-term care in the U.S. Well-versed in all aspects of the increasingly stringent regulatory climate, we also deliver on the underlying policy, business and strategic needs of assisted living facilities.
Behavioral and Mental Health
Nelson Hardiman has been a leading adviser with respect to legal, regulatory, and risk issues related to mental health. Mental health continues to be an overriding challenge not only for employers and healthcare providers, but for our entire society. In May 2020, 90% of American adults reported experiencing heightened levels of mental strain caused by […]
Nelson Hardiman represents behavioral health treatment facilities large and small. We understand how legal and regulatory issues challenge today’s behavioral health facilities, and proactively help our clients address ethical and regulatory concerns within the context of behavioral healthcare and legal dynamics. To that end, we launched the American Addiction Treatment Association to fill a regulatory compliance void in the industry.
Nelson Hardiman is a leader in the rapidly expanding biologics industry. We navigate the significant regulatory, intellectual property and business challenges of biologics, which represent many of the most promising new treatments for cancer and other major diseases. Our focus on healthcare innovation magnifies our strong interest in biologics and our awareness of the costly technologies and the manufacturing techniques needed to produce biologics, as well as the urgency to market these treatments.
From the fabled cannabis farms in the north to the “green rush” in the Sierra foothill counties, navigating the complexities of conflicting local, state and federal marijuana laws is no easy task. We have worked with multiple jurisdictions on marijuana regulations. We represent individual growers, property owners and investors who finance marijuana businesses from the ground up. Nelson Hardiman attorneys have the in-depth industry experience and nuanced understanding of laws in transition that cannabis cultivators need to navigate growth opportunities while mitigating the inherent risks in the burgeoning cannabis industry.
Unmatched experience defines the scope of our work with cannabis dispensaries. Our work with local and state government has played a singular role in shaping the path of California marijuana laws, making us the ideal partner for cannabis dispensaries statewide.
The evolving cannabis industry is a growth sector funded by investors attracted by the high-risk/high-reward opportunities offered by the cultivation, distribution, and sale of legal marijuana. Nelson Hardiman combines nearly a decade of hands-on experience shaping the path of California marijuana laws with a deep bench of transactional talent handling sophisticated corporate transactions.
Nelson Hardiman assists with cannabis licensing regulations focusing on navigating complicated local and state licensing application processes for cannabis-related businesses in California.
Manufacturers, operating in one of the most exacting sectors of the emerging cannabis industry, rely on Nelson Hardiman to guide every phase of their business ventures. We are a trusted and respected authority on the complexities of marijuana laws with more than a decade of experience advising leading business entities. Our combined experience gives us a nuanced understanding of the needs of marijuana manufacturers from the ground up.
At Nelson Hardiman, we see clinical research as the place where innovation can thrive, centered on initiatives to move medicine forward. We apply our healthcare industry experience to navigating the legal considerations and regulatory compliance issues required to set up, monitor and complete a clinical research trial.
Nelson Hardiman represents physicians who specialize in aesthetic medicine. We are known for our deep experience and successful track record in accomplishing the goals of our aesthetic medicine providers and medical spa clients. We counsel on business issues, protect against regulatory investigations, and defend high stakes litigation.
As COVID-19 evolves from a pandemic to an endemic virus, it will continue to challenge and demand changes not only for healthcare organizations and in our systems of public health, but for all businesses. COVID has already driven waves of legislation and regulatory initiatives at every level of government, and will continue to reshape our […]
Recognized leaders in healthcare law, Nelson Hardiman advises dentists and other oral healthcare providers on legal and regulatory issues in the dental industry. From practice management, ethical and regulatory considerations, to insurance marketplace challenges and enhanced prescribing regulations in today’s climate of regulatory abuse, dentists are held to increasingly stringent standards of care.
Nelson Hardiman is at the forefront of issues affecting the diagnostic imaging and testing industry and provides legal representation across the full spectrum of business regulatory and compliance issues. As the government continues to investigate and prosecute fraud and abuse within the diagnostic imaging and testing arena, we ensure that facilities rise to the challenge of maintaining compliance across a multitude of coverage, billing and coding rules and regulations.
Nelson Hardiman’s thought leadership around the future of healthcare has driven many next-generation healthcare concepts to realization. The convergence of healthcare and the internet opens up a world of possibilities and a vast array of legal issues. Our leading role in the digital health transformation ideally positions Nelson Hardiman to help digital health providers comply with the complex web of federal and state regulations to achieve their business goals.
Direct to Consumer Health
For nearly two decades, Nelson Hardiman has been a leading resource nationally for direct-to-consumer (DTC) areas of healthcare, where providers bypassed insurance reimbursement in favor of marketing cash-pay resources to consumers, from aesthetics to a broad array of health and wellness. Nelson Hardiman brings hard-earned experience advising on direct-to-consumer healthcare business structures (including compliance with […]
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Durable Medical Equipment
Nelson Hardiman knows the durable medical equipment (DME) space and provides DME companies with turnkey legal counsel across a wide range of business, regulatory, and strategic challenges. In the face of escalating compliance issues, we help durable medical equipment companies provide a lifeline for people who depend on medical equipment for critical life-saving issues and day-to-day living needs.
FQHC’s Health Clinics
Nelson Hardiman provides legal counsel to enable Federally Qualified Health Centers (FQHCs) to fulfill their critically important mission as local community healthcare providers. We guide non-profit community clinics through the complicated regulatory framework to form FQHCs. We have worked closely with these community-based organizations, including both Section 330 grantees and “look-alike” FQHCs, to maintain compliance while collaborating on creative solutions for advancing their mission.
As innovators across the healthcare and life science industry seek out Nelson Hardiman’s guidance, genomics has become an increasing area of the firm’s advice and representation. Nelson Hardiman was ranked as a “Tier 1” law firm in 2022 by US News and World Report for its groundbreaking work in the life sciences industry. We counsel […]
Known for our work in the behavioral health industry, Nelson Hardiman represents a broad range of residential facilities throughout Los Angeles and the State of California. The state’s leading providers of group home services trust us to understand the industry and their business objectives.
Health Care Plans
Physicians challenged by the changing reimbursement and regulatory landscape rely on Nelson Hardiman to navigate complex health care plan options that form the basis of Independent Physician Associations (IPAs). We negotiate health care plan agreements that deliver seamless solutions for IPA members beset by administrative burdens.
Health Information Technology
Immersed in the strategic ideas and innovative concepts of health information technology (HIT), we advise on the ever-changing regulatory landscape and emerging industry trends to help our HIT clients optimize billing practices, enhance the patient experience, optimize safety, and protect data privacy while making healthcare more accessible for everyone.
Home Health Agencies
In the ongoing healthcare revolution, the preference for home care aligns with government and payor desire to reduce costs. This convergence, coupled with growing technological support, fuels interest in convalescing at home. New care delivery models and consumer demand stoke tectonic shifts in the competitive landscape, creating challenges and opportunities for home health agencies to collaborate with other healthcare providers to extend patient care into alternative care settings. Nelson Hardiman’s solution-oriented experience across the full spectrum of alternative care issues offers home health agencies the regulatory oversight and strategic vision to accomplish their business goals in an evolving healthcare universe.
Nelson Hardiman has a firm grasp on the complex Medicare regulations for hospice care providers. We leverage our understanding of these complicated reimbursement requirements to provide seamless counsel on the myriad legal issues involved in caring for terminally ill patients.
Hospitals & Health Systems
A leader in healthcare law, Nelson Hardiman provides mission-critical legal counsel to hospitals and health systems. Known for our innovative and creative approach to solving the most complex issues in healthcare, we offer a depth of experience and insight that healthcare organizations cannot live without.
Independent Physician Associations
Nelson Hardiman accomplishes the goals of primary care physicians facing new challenges from the evolving medical, technological and regulatory landscape. The resurgence of managed care, accelerated by the Affordable Care Act (ACA) drives the increased migration of physicians out of private practice into managed-care, hospital-affiliated independent physician associations (IPAs), creating new operational and alignment issues for physicians and setting the stage for new models of delivering healthcare services such as concierge practices and telemedicine.
Our understanding of the healthcare industry’s regulatory landscape and trends gives Nelson Hardiman significant insight into the complex legal issues impacting medical laboratories. Independent clinical labs and those affiliated with hospitals and health systems are equally affected by ever-changing regulations and managed care contracting challenges. Nelson Hardiman has the knowledge and experience to ensure laboratories remain compliant and stay in business.
Nelson Hardiman has earned a singular reputation in advising laboratories on risk, compliance, and other business and regulatory issues. Diagnostic testing has been both an area of exciting breakthroughs in technology, and an epicenter of risk as government and insurance companies seek to root out suspected fraud and abuse. Nelson Hardiman has comprehensive experience guidance […]
Nelson Hardiman understands the unique healthcare environment of long-term care facilities (LTCFs) – including nursing facilities, skilled nursing facilities, rehabilitation facilities and assisted living facilities. With an unrivaled mix of industry experience, first-hand knowledge of operational issues, and a keen focus on regulatory compliance, our attorneys excel at finding innovative, creative solutions to meet the complex needs of long-term care facilities.
Managed Care Entities
Nelson Hardiman has decades of on-point experience with managed care entities. Envisioned as a transformative for-profit model driven by the insurance industry, we cut our teeth on Health Care Maintenance Organizations (HMOs), the first form of managed care. Today we use our business acumen and first-hand knowledge of healthcare systems to provide strategic and practical guidance on operational, regulatory, transactional, and litigation matters for limited Knox-Keene and HMO entities.
Management Services Organizations
Our leadership position in the healthcare industry makes us adept at understanding the unique business needs of Management Services Organizations (MSOs). Because we know every aspect of healthcare law, we frequently sit at the same table with MSOs and providers. We are masters at the complex issues that arise around practice management related non-medical business functions. We hammer out MSO legal agreements around the corporate practice of medicine doctrine and help MSOs navigate the fraud and abuse arena, including anti-kickback, self-referral and fee-splitting regulations. MSOs rely on us for our highly-attuned sensitivity to the complex interplay between developing integrated practice care standards and realizing savings with third party payors, based on our shared vision of transforming the delivery of healthcare services.
At Nelson Hardiman, we understand that FDA regulatory compliance is the key to success for medical device companies. Our strong healthcare regulatory experience helps our clients navigate the competitive and evolving industry. From our catbird’s seat we keep an eye on the future for medical device technology and innovation, prepared to problem-solve the next legal challenge.
Medical Staff Representation
Nelson Hardiman provides pro-active counsel, independent of in-house counsel, to consult on peer review matters, represent medical staff in hearings, conduct interviews and discovery before litigation, and provide legal representation of medical staff during litigation and on appeal.
Nelson Hardiman understands that providing healthcare services to individuals with mental health issues is complicated — requiring an understanding of the multiple bodies of law that govern the treatment, rights and protections of these patients.
Mental Health Professionals
Nelson Hardiman supports the mission-critical legal needs of mental health professionals in healthcare systems and private practice in California and throughout the U.S. Psychologists and other mental health professional trust us to resolve their business, regulatory, and strategic challenges. With an impressive roster of seasoned healthcare attorneys and a national reputation for business acumen we help health professionals succeed in today’s evolving healthcare environment.
Nurses and related healthcare professionals rely on Nelson Hardiman to navigate a highly regulated environment with rapidly evolving roles and scopes of practice. From licensing, bylaws and administrative proceedings to professional liability and risk management concerns, we’ve advised clients across all phases of healthcare compliance, and provided guidance and legal representation defending litigation claims. Our team blends the restorative mindset and insight of a healthcare professional with the legal strengths of field-tested healthcare attorneys. We’re committed to delivering legal solutions that achieve exceptional results for nurses and allied healthcare professionals.
Driven by a paradigm shift in lifestyle trends and health habits, the expanding market for nutraceuticals/dietary supplements is balanced by regulatory pressures and headline-grabbing intellectual property/trade secret, and litigation issues. Nutraceutical companies choose Nelson Hardiman as their business and litigation counsel because of our broad healthcare capabilities and our deep commitment to transformative innovation and entrepreneurial opportunities.
Our vast healthcare experience and deep pharmaceutical industry knowledge helps our clients navigate this competitive and highly regulated industry. With an eye on the future of healthcare innovation, we diligently track the regulatory landscape and emerging industry trends, focused on legal protections related to the development of pharmaceutical products and services.
Nelson Hardiman understands the myriad laws and regulatory hurdles impacting pharmacies in an era of rapid growth and change for the healthcare industry. Fueled in part by the digital health revolution, new prescription standards and privacy and security requirements compound the challenge for digital and traditional pharmacies nationwide. Our healthcare team, including attorneys from our […]
Attune to the essential role of physical therapists in today’s healthcare delivery system, Nelson Hardiman charts a steady course through the regulatory challenges and business concerns that beset this growth sector of the healthcare industry. Pioneers in the telehealth transformation, we advise physical therapists on the telehealth models and regulatory laws involved in offering telehealth services. Our healthcare-centric attorneys combine strategic counsel with extensive experience negotiating business agreements and contracts and defending against complex regulatory compliance claims. Nelson Hardiman provides our physical therapist clients with the legal foundation to accomplish their professional goals.
Strong regulatory support and a keen grasp of business are the keys to success in any physician practice. Nelson Hardiman helps physician subspecialists manage the constantly changing regulatory climate and achieve their financial and market objectives in the rapidly evolving healthcare industry.
Nelson Hardiman’s undisputed knowledge of the healthcare sector and keen insights into industry trends inspires our counsel on physician-hospital ventures. Providing support for the realignment of the healthcare industry, we structure entities that benefit patients, physicians, and hospitals. We negotiate complex financial vehicles and address the full spectrum of business, regulatory and strategy concerns to build and sustain physician-hospital ventures.
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Professional License Defense
Nelson Hardiman has a strong record successfully representing and defending numerous healthcare and ancillary care professionals before the various licensing boards of the State of California, including the Medical Board of California, the Board of Psychology, the Board of Behavioral Sciences, the Dental Board, the Board of Registered Nursing, theBoard of Chiropractic Examiners, the Board […]
Nelson Hardiman has advised clients on ketamine-related issues for close to two decades, from the time period after it was added to DEA Controlled Substances list as a Schedule III synthetic compound and doctors began to be disciplined for providing it until today, when interest in therapeutic uses continues to rise substantially. Beyond its historic […]
Regulated Substances: Medical Cannabis
Nelson Hardiman is proud to have been the first law firm in the country, beginning in 2009, to provide regulatory guidance related to medical uses of cannabis to health professionals, product manufacturers, and other industry participants. Cannabis-related questions involve substantial complexity as a result of the combination of decriminalization in the overwhelming majority of States […]
Understanding the evolving healthcare industry and helping clients prepare for the looming “silver tsunami” empowers Nelson Hardiman to advise on senior services. Our focus on healthcare innovation and next generation healthcare provides a natural segue to today’s senior living facilities. We represent and counsel clients on business, regulatory and strategic challenges, helping senior services providers tackle regulatory hurdles, avoid disruption and financial distress, and tackle the shift in the competitive landscape towards new care alternatives.
Skilled nursing facilities (SNFs) depend on Nelson Hardiman for the legal experience to navigate the complex healthcare environment. From the acquisition and financing of SNF facilities to regulatory compliance programs and criminal investigations, we advise clients across all phases of the business cycle, as well as on complex financing, operational, regulatory and dispute matters.
For over a decade, Nelson Hardiman has played a leadership role in advising both leading organizations nationally and start-ups on the essential regulatory issues underlying the telehealth transformation. We have worked with clinicians and business leaders to develop regulatory pathways for cutting-edge forms of telehealth, including teledermatology, tele-mental health, and teledentistry. We have advised on numerous first-of-a-kind telehealth models, analyzing the myriad healthcare regulatory laws and regulations implicated in these projects.
Leaders in healthcare innovation, Nelson Hardiman provides deep insights and strategic counsel on the new era of value-based care (VBC). Rapidly supplanting the waning “fee-for-service” era of volume-based reimbursement, we help integrative health systems manage risk and optimize VBC models in their practices.
Youth and Family Services
Nelson Hardiman is adept at confronting the legal issues encountered by healthcare providers and programs that treat children with autism, developmental disabilities, and other related language disorders. Our knowledgeable counsel resolves regulatory challenges head on, proactively positioning providers of youth and family healthcare services for optimal effectiveness.
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