Williams Mullen advises physicians and physician groups on the complete spectrum of transactional, regulatory, and operational matters, including corporate governance, joint ventures, employment, privacy, licensure, fraud and abuse, and compliance. Drawing upon extensive experience, our dedicated health care team takes the lead on these matters and obtains significant support from other practice groups throughout the firm.
Outside General Counsel
We understand the fast-paced and pressure-filled nature of physician group practices and the many issues that must be carefully navigated. Our responsive and efficient attorneys routinely help providers who do not have in-house legal capabilities with matters ranging from operational issues to strategic planning. For practices with in-house counsel, our lawyers collaborate and provide supplemental support.
We also provide strategic advice related to the development of new service lines, the expansion of a practice to additional locations, and partnerships or other legal affiliations with hospitals and other providers.
M&As, Joint Ventures, and Affiliations
Drawing on our deep bench of corporate, tax, and regulatory experience, we provide comprehensive advice to health care providers engaged in integration and collaboration with other providers or payors through mergers, acquisitions, joint ventures, affiliations, management agreements, and risk-sharing arrangements.
Our industry experience includes joint ventures between taxable and non-taxable entities and the use of multiple financing sources, including private equity and debt, to structure and bring to fruition transactions that comply with applicable regulations and help to generate optimum business results for our clients. We also apply our regulatory and operations experience to perform due diligence reviews of entities.
Certificate of Need/Certificate of Public Need
Our Certificate of Need (CON)/Certificate of Public Need (COPN) practice melds our knowledge of the health care industry with our experience in helping clients develop and implement competitive strategies. CON/COPN laws are important tools for providers, both offensively and defensively. When strategically utilized, CON/COPN laws enable providers to respond to current needs, position themselves for further growth, ensure highly utilized services, and, from a competitive perspective, contain duplicative or unnecessary proliferation of new services and facilities.
For physicians in various specialties, we are mindful of the critical importance of adequate access to operating rooms, endoscopy rooms, and diagnostic imaging modalities such as PET and MRI scanners. Whether independently or in joint venture arrangements, we assist physician groups in advocating for needed equipment, services, and facilities.
Our attorneys who focus on CON/COPN matters bring together clinical, policy, legal, and business acumen to help clients develop and implement thoughtful, effective CON/COPN strategies.
- Developing strategy and drafting applications
- Navigating the CON/COPN administrative process
- Tracking and advising on CON/COPN opportunities
- Litigating contested CON/COPN matters
- Assisting with CON/COPN reporting requirements
- Advising on material compliance requests
- Assisting with no-review filings
- Developing opposition strategies
We help health care providers manage risk, maintain a more consistent revenue stream, and have the necessary resources to meet the needs and manage the costs of their expanding health care populations.
Our experience includes:
- Managed care contracting
- Clinically integrated networks
- Compliance with Medicare and Medicaid billing rules
- Value-based payment programs
- Responding to billing disputes
HIPAA and Privacy
We advise providers and vendors on privacy and security issues related to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act, which govern the use and disclosure of Protected Health Information (PHI). Our attorneys have substantial experience helping clients navigate legal requirements for covered entities and business associates, including assistance with breach notifications and breach prevention strategies as well as resolving ransomware attacks and the HIPAA concerns that arise from such attacks.
- Comprehensive compliance programs, including review and drafting of Privacy Rule, Security Rule, and Breach Notification Rule policies.
- Contract review (appropriate use of business associate agreements and selection of potential designations, such as affiliated covered entity and hybrid entity status).
- Breach notification requirements and mitigation under HIPAA and state law.
One of our attorneys, Nathan Kottkamp, earned the designation of a Certified Information Privacy Professional (CIPP) through the International Association of Privacy Professionals (IAPP).
Click here to access our HIPAA Tips With Williams Mullen video series.
Regulatory, Accreditation, and Licensing
Decades of experience in health care regulatory, accreditation, and licensing matters enable us to counsel clients on what they should do now to avoid a decrease in or total loss of reimbursement, penalties, disruptions to their operations, and even criminal liability.
We help health care clients with the following types of regulatory matters:
- Licensure (individual and facility)
- The Physician Self-Referral Law (Stark law)
- The Anti-Kickback Statute (AKS)
- The False Claims Act (FCA)
- The No Surprises Act
- The Emergency Medical Treatment and Active Labor Act (EMTALA)
- The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- The Joint Commission and the Accreditation Association for Ambulatory Health Care (AAAHC)
Clinical Research Studies
We regularly represent health care providers participating as principal investigators and sites in clinical trials, including the drafting and negotiation of clinical trial agreements with sponsors and contract research organizations (CROs). We also review and advise providers on ancillary agreements and documents related to clinical research studies, such as informed consent forms (ICFs), HIPAA authorization forms, data use agreements, investigator and sub-investigator acknowledgments, confidentiality agreements, and institutional review board (IRB) appeals.
We help clients to navigate the varying state and federal laws and regulations affecting reimbursement rates, coverage by government payors, privacy issues, and interstate policies regarding the practice of medicine across state lines. We have broad experience in helping clients identify potential liabilities and advising on compliance with the rapidly evolving regulations and policies in the telehealth arena.
Audits, Appeals, and Investigations
Medicare/Medicaid and other third-party payor audits, investigations, and enforcement actions can be extremely damaging to a provider’s operations and reputation. Our health care lawyers partner with the firm’s White Collar and Investigations Team to provide our clients with the full spectrum of services needed to timely evaluate and respond to governmental actions and to vigorously defend their business interests and reputation.
We provide counsel on the following types of matters:
- Preparation of responses to records requests, audits, or recoupment demands
- Assistance with penalties, admission suspensions, or license revocations
- Management of government investigations and subpoenas
- Guidance on False Claims Act (FCA) and Civil Monetary Penalty (CMP) cases
- Preparation and filing of plans of correction
- Participation in civil litigation actions, arbitrations, and mediations
- Assistance with audits and investigations
- Resolution of overpayment claims
- Advice on medical necessity challenges and up-coding disputes
- Review of reimbursement matters, including Medicare and Medicaid reimbursement appeals
- Assistance with payor grievances through state insurance regulators
- Defense of fraud and abuse claims, FCA, and the Stark law, including white collar defense
Williams Mullen’s Tax Law Section helps physicians and physician groups reduce their tax liability while complying with all applicable state and federal tax laws. Our tax attorneys’ experience includes, but is not limited to:
- 401(k) plans
- Business succession
- Corporate structure
- Entity selection
- Payroll tax disputes
- Real estate holdings
- Sales and use tax audits
- Sales and combinations of medical practices
Data Protection and Cybersecurity
Health privacy and security issues under HIPAA are only part of the cybersecurity landscape. A broad spectrum of data laws at the state, federal, and international levels may apply to digitally held information. Williams Mullen combines its HIPAA-related experience with the targeted assistance of our Data Protection & Cybersecurity Team, which can advise clients regarding a broader range of potentially applicable laws and issues such as:
- Complying with privacy laws and data management
- Enacting privacy policies and programs
- Negotiating and advising on vendor contracts
- Avoiding, mitigating risk from, and responding to data breaches, ransomware attacks, and subsequent reporting obligations and litigation
- Adopting new technologies such as biometrics, geolocation, and artificial intelligence (AI)
Our team has the resources to handle these matters and coordinates with cybersecurity and forensics vendors, IT professionals, and governmental agencies to ensure compliance with relevant law. Should litigation arise, our litigators defend practices in an efficient and practical manner to avoid liability and undue cost.
Labor, Employment, and Immigration
Health care providers routinely encounter unusual and complex issues in the employment arena due to the highly regulated nature of the health care industry. Williams Mullen’s health care clients rely on our Health Care and our Labor, Employment, and Immigration (LEI) Sections working together for a wide array of employment-related matters, ranging from routine employment issues to structuring physician compensation, to non-compete enforceability to advice on the implementation of workplace practices that affect specific compliance goals.
Our experience includes:
General Employment Matters
- Advice regarding employment laws and regulations, including Equal Employment Opportunity (EEO) laws, the Fair Labor Standards Act (FLSA), the Family and Medical Leave Act (FMLA), the National Labor Relations Act (NLRA), and North Carolina and Virginia law
- Advice regarding hiring, discipline, terminations, reductions in force, medical leave issues, and EEO matters
- Defense of U.S. Equal Employment Opportunity Commission (EEOC) claims and related litigation, and general employment litigation
- Occupational Safety & Health Administration (OSHA) compliance advice and defense of claims
- Immigration advice, I-9 advice and audits, and preparation of in-bound visa petitions
- Fair Credit Reporting Act (FCRA)-related advice
- General human resources support and advice, including development of policies and diversity and inclusion initiatives
- Physician employment agreements, separation agreements, and restrictive covenant agreements
Medical Staff Matters
- Medical staff/credentialing issues and disputes
- Professional licensure issues and Board proceedings
- Employment contracts
- Physician compensation and contracting
- Non-physician practitioners
- Leased employees
- Administrative employees
- Contract termination considerations
- Separation agreements
Employee Benefits and Executive Compensation
Williams Mullen’s Employee Benefits and Executive Compensation Practice offers a wealth of technical knowledge and practical advice to help physicians and physician groups design and implement employee benefits arrangements and comply with applicable laws.
We assist clients with the following types of matters:
- Tax-favored retirement plans, such as 401(k), 403(b), and cash balance plans
- IRS and Department of Labor correction procedures
- Welfare plans, such as group health and disability plans
- Fiduciary responsibilities and litigation issues
- Mergers and acquisitions
- Executive compensation and severance arrangements
- Code Sections 457 and 409A compliance
Williams Mullen’s Intellectual Property Practice is nationally recognized for protecting, enforcing, and defending against asserted intellectual property rights at the state, federal, and international levels. Our attorneys have broad experience prosecuting, licensing, enforcing, and defending trademarks, copyrights, patents, and trade secrets in a wide range of industries, including health care, life sciences, software, and technology.
Our attorneys have the depth of experience to manage and advise clients either through in-house attorneys and specialists or directly with the company’s business leaders. Our clients range in size from startups to Fortune 500 companies, in geography from regional to national and global companies, and in industry.
Health care providers operate in a highly regulated, intensely competitive environment and face rapidly changing business and legal challenges. The financial stakes in health care litigation are high, and the outcomes can threaten a provider’s survival. Because of the specialized issues and the consequences of adverse outcomes, effective resolution of health care disputes requires attorneys with the experience and resources to meet those challenges. Williams Mullen’s health care clients rely on our Litigation Section for a wide array of sophisticated commercial, regulatory, and liability matters.
Our experience includes:
- Reimbursement and contract disputes between health care providers and insurers
- Merger and acquisition disputes between health care providers
- Electronic medical records (EMRs), including contract disputes with EMR vendors
- Contract and commercial disputes
- Certificate of Need (CON) and Certificate of Public Need (COPN) appeals
- Arbitrations conducted through the American Health Lawyers Association (AHLA)
- Medicare/Medicaid reimbursement/recoupment appeals
- False Claims Act (FCA) litigation defense (criminal and civil)
- Government investigations/audits
- Licensure disputes/appeals
- Medical staff/credentialing disputes
- Professional licensure board proceedings
- Negligence and premises liability defense
- Labor and employment disputes involving health care entities
- Defense of civil rights claims involving health care providers
- Internal investigations regarding FCA violations
- Implementation of HIPAA Security Rule Risk Assessments
Williams Mullen's Real Estate Practice includes more than 40 attorneys and is widely recognized for its experience and knowledge of commercial real estate law. Several of our real estate attorneys have developed particular focus on medical office building development and physician practice-related real estate structures. Section attorneys counsel clients on all aspects of real estate, including land use and zoning, site plan approval, leasing, acquisitions and sales, and complex financings.
THE MATTERS LISTED BELOW ARE ILLUSTRATIVE OF THE MATTERS HANDLED BY THE FIRM. MATTER RESULTS DEPEND UPON A VARIETY OF FACTORS UNIQUE TO EACH MATTER. NOT ALL MATTER RESULTS ARE PROVIDED. MATTER RESULTS DO NOT GUARANTEE OR PREDICT A SIMILAR RESULT IN ANY FUTURE MATTER UNDERTAKEN BY THE LAWYER.
- Represented a large orthopedic physician group in the negotiation of a joint venture value-based care network with a private equity-backed management organization.
- Represented an independent radiology group in the negotiation of a joint venture interventional laboratory with other private equity-backed physician groups.
- Represented physicians and physician groups in the organization of joint venture ambulatory surgical centers (ASCs) with management companies and hospitals.
- Assisted an orthopedic practice with the legal aspects of the development of a CON-approved surgery center, including physician buy-in agreements and corporate filings.
- Advised an emergency medicine practice group on a corporate reorganization resulting in the consolidation of several practice groups.
- Represented a startup physician group providing direct health care services in the development of a customer master services agreement.
- Represented a physician practice group in the negotiation of an anesthesia services agreement with a large health system.
- Advised an oncology practice on an arrangement with a company providing drug rebate aggregation services.
- Represented multiple emergency physician groups in the negotiation of hospital professional service agreements.
- Negotiated a variety of vendor contracts for a large orthopedic physician group.
- Advised a physician group in the negotiation of a payment dispute with a national health insurer.
- Advised an audiology practice on corporate organization and governance, employment matters, vendor contracting, and compliance with the Anti-Kickback Statute.
- Advised a health system’s physician practice entity on health care regulatory matters, provider employment agreements, and compliance with the Stark law and Anti-Kickback Statute.
- Advised a specialty physician practice group on the resolution of a potential Stark law violation resulting from a hospital professional services agreement.
- Represented a large physician group in a health care fraud and abuse investigation conducted by a U.S. Attorney’s Office.
- Represented multiple physician groups in the investigation of reimbursement issues and resolution of overpayments to government and commercial health insurers.
- Advised multiple physician groups on the resolution of unrefunded credit balance.
- Represented a medical practice in an investigation by the HHS Office of Inspector General.
- Represented a radiology practice group in all matters related to its business, including corporate governance, employment matters, hospital contracting, negotiation of joint ventures, and payor reimbursement.
- Guided a physician pathology group through the process of updating and improving its corporate organizational documents and physician employment agreements.
- Assisted a medical practice with notifications, reporting, and investigation support after a cyberattack.