Health Care Law

Health care organizations and medical professionals face an increasingly complex legal, regulatory, and business environment. Smith Anderson’s team of experienced lawyers advises health care facilities, providers, practitioners, and industry organizations nationwide on the legal and strategic issues that shape the business and delivery of health care, from health care policy, legislative advocacy, and executive strategy, to mergers and acquisitions, data privacy and security, litigation, and the complex business requirements of organized medicine. We regularly serve as outside general counsel to health care providers, operators, and trade associations, providing practical counsel on governance, regulatory compliance, operations, transactions, and other matters critical to achieving our clients’ organizational and business objectives.

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Industry Leadership

For decades, Smith Anderson has been at the forefront of the industry’s evolution, helping launch innovative health care delivery models such as clinically integrated networks, joint ventures between health systems and practitioners, Community Care of North Carolina, and accountable care organizations (ACOs) across the country. In addition, we counsel a variety of health care organizations and physicians on value-based payment and population health strategies, including ACOs, bundled payment, and clinically integrated networks. Our health care practice also has particular strength representing long-term care providers, including skilled nursing, assisted living, and independent living organizations.

Our attorneys have handled a variety of high-profile health care litigation matters, ranging from hospital governance and financing to certificate of need, health care regulatory, reimbursement, professional malpractice, and government investigations. Smith Anderson has been involved in some of the most important issues facing the health care industry in the courts.

As a result of the strengths noted by our clients and peers, Chambers USA, one of the world's leading legal ranking agencies, has recognized our Health Care practice as a leader in North Carolina. Plus, Best Law Firms® has recognized our Health Care practice since 2011. Whether serving as outside general counsel, guiding transformational transactions, or helping clients navigate complex regulatory and litigation matters, our goal is to provide practical solutions that allow health care organizations to remain focused on delivering exceptional care to the patients, residents, and communities they serve.

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Services

• Health care mergers and acquisitions, including practice buy-ins and buy-outs
• Medicare and Medicaid compliance
• Medicare Shared Savings Programs (MSSP) and other value-based reimbursement initiatives
• Electronic Health Record implementation and related services
• Professional association representation
• Certificate of Need (CON)
• HIPAA compliance and other federal and state confidentiality and privacy laws
• Managed care contracting and dispute resolution
• Medicare and Medicaid fraud, waste, and abuse defense
• OIG/DOJ investigations
• False Claims Act
• Stark Law / Anti-Kickback Statute
• Resolution of regulatory issues and administrative litigation
• Representation before licensing boards
• Antitrust
• Practice and business entity formation
• Strategic general counsel services, including governance and Board matters
• Medical staff issues
• Provider organizations
• Exclusive contracting
• Employment issues, including covenants not to compete 

Podcast

Listen and follow Pulse on Carolina Health, a Smith Anderson podcast delving into current health care trends, regulations and policies shaping the landscape in North Carolina. In each episode, our host pairs up with industry executives and leaders from across the state to discuss where their finger is on the pulse of timely health care topics and to broadcast issues of importance that affect their business most. Tune in to stay informed about the latest developments in health care law, policy, and industry trends and discover what’s driving change in North Carolina’s health care system.

Follow Pulse on Carolina Health on your favorite podcast app.

Transactions & Deals

• Represent buyers and sellers in hospital acquisitions, including transactions involving public finance, local government, and regulatory compliance issues.
• Represent private equity sponsors and strategic investors in health care mergers, acquisitions, and platform investments, guiding deals from diligence through closing and post-closing integration.
• Advise on CON requirements in connection with facility acquisitions, expansions, and the development of new health care services.
• Represented seller in sale of multi-location behavioral health treatment facility.
• Counsel hospitals and health systems through affiliation, integration, and joint operating arrangements.
• Negotiate complex health care agreements and transactions, including master services agreements, joint ventures, and management arrangements.
• Draft and negotiate physician employment, compensation, and joint venture contracts, aligning arrangements with fraud and abuse requirements.
• Advise buyers and sellers on CON issues in health care mergers, acquisitions, and change of ownership transactions.

Formation & Structuring

• Form and counsel accountable care organizations (ACOs) participating in the Medicare Shared Savings Program, other Medicare and Medicaid arrangements, and commercial value-based programs.
• Structure and form physician organizations (POs), physician-hospital organizations (PHOs), and independent practice associations (IPAs).
• Establish management services organizations (MSOs) and clinically integrated networks, including ongoing regulatory and operational counsel.
• Advise on corporate practice of medicine (CPOM), fee-splitting, and referral-fee laws across multiple states, structuring arrangements to withstand regulatory scrutiny.

General Counsel & Governance

• Serve as outside general counsel to hospitals, physician groups, medical societies, and health care trade associations, handling day-to-day operations, governance, regulatory compliance, member policies, and legislative and policy positions.
• Provide ongoing general counsel representation to a national collaborative care organization with thousands of participating providers and facilities.

Regulatory, Policy & Legislative

• Prepare and file certificate of need (CON) applications for long-term care and hospice providers.
• Perform statistical and need-based analyses to support CON applications across multiple jurisdictions.
• Advise providers on CON regulatory compliance, including no-review and exemption determinations for proposed projects.
• Counsel clients on federal and state health care legislative and policy developments, including Medicaid reimbursement, provider licensure, and hospital regulation.
• Advise providers on No Surprises Act compliance, including out-of-network billing, patient notice and consent requirements, and independent dispute resolution (IDR).
• Advocate for clients in North Carolina rulemaking and legislation, preparing comment letters, bill language, and submissions to the North Carolina Department of Health and Human Services, other state agencies, and the North Carolina General Assembly, and engaging directly with agency and legislative staff on health care regulatory and statutory matters.
• Advise clients on federal health care legislation and rulemaking, including preparing comments and legislative submissions to CMS, HHS, and Congress.
• Advise clients on Anti-Kickback Statute (AKS), Stark Law, and Physician Payments Sunshine Act compliance, structuring arrangements to fit within safe harbors and exceptions.
• Represent health care providers in state medical board, pharmacy board, and licensing board inquiries and investigations, engaging directly with regulators to resolve matters favorably.

HIPAA & Privacy

• Develop and manage HIPAA and 42 CFR Part 2 privacy and security compliance programs for health systems, including drafting policies, procedures, and business associate agreements.
• Guide clients through HHS Office for Civil Rights (OCR) investigations and audits, and lead HIPAA incident and breach response from initial assessment through regulator engagement.

Managed Care & Disputes

• Represent health care providers and facilities in managed care contracting and payer disputes, including out-of-network issues.
• Successfully appealed termination decisions by managed care organizations and Department of Health and Human Services.
• Represent health care providers in Medicare, Medicaid, and commercial payer audits and appeals, defending against overpayment demands and recoupment actions.