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Healthcare

LeClairRyan's Healthcare industry team is comprised of attorneys who are well-positioned to address the magnitude of issues affecting all segments of the healthcare industry, including group physician practices, community hospitals, academic medical centers, small health systems, skilled nursing and long-term care facilities, urgent care facilities, home health companies, durable medical equipment suppliers, and clinical labs, in a proactive and timely manner.

Representing clients in a full spectrum of issues – from business operations and corporate compliance to investigations and litigation – we strive to become our clients’ trusted advisor in every matter. We apply our knowledge, insight and skill to help clients achieve their business objectives while managing and minimizing their legal risks, difficulties and expenses.

Members of our team regularly provide leading business counsel to healthcare companies nationwide and possess a breadth of jury trial and appellate court experience representing clients in matters before entities such as state licensing boards, insurance credentialing committees and investigative agencies.

Healthcare Regulatory, Transactions & Compliance

Members of our multidisciplinary team serve a variety of business sectors within the healthcare industry, including:

  • Affordable Care Act (ACA)
  • Fraud and Abuse, Stark Law, Anti-Kickback
  • Government Audits, Surveys and Subpoenas
  • Corporate Governance
  • HIPAA/HITECH & Electronic Health Records (EHR)
  • Medical Staff
  • Joint Ventures, Mergers & Acquisitions, ACOs
  • Physician Recruitment and Contracting
  • Regulatory and Accreditation Compliance
  • Tax-exempt bond and conventional financing
  • Commercial Contracting and Licensing
  • Reimbursement and Coverage
  • Clinical Research and IRBs
  • Pharmacy Law

Healthcare Litigation

Members of our Healthcare Litigation team serve in a variety of sectors regarding Heathcare Litigation, including:

  • Criminal and Civil Regulatory Defense
  • Medical Malpractice
  • Medical Products Liability
  • Professional Licensure Actions
  • Administrative and Reimbursement Appeals
  • Alternative Dispute Resolution

Industry Insights

Our healthcare attorneys know how to best handle each issue they encounter because they have a practical understanding of the industry they serve. Among our team members are attorneys who have served as:

  • State assistant attorney general
  • U.S. Department of Justice senior trial counsel
  • Deputy and acting chief for the criminal division of a U.S. Attorney’s office
  • Federal Trade Commission regional director
  • Healthcare system executives
  • Practicing certified physician assistant
  • Hospital in-house general counsel

As healthcare attorneys, we work diligently with our clients to identify, address, and correct actions or oversights that could hinder their medical practices and businesses. When a client is confronted with a legal problem, we quickly triage the situation, make a preliminary diagnosis, prescribe a therapy, measure its effectiveness, and make the necessary recommendations to ensure it does not arise again.

Our distinctive strengths include:

  • AFFORDABLE CARE ACT COMPLIANCE
    The complex challenges and vague statutory provisions presented by the Affordable Care Act (ACA) require employers to act immediately, as many of the law’s mandates are either already in place or becoming effective in 2013 and 2014. Employers who fail to take action risk substantial penalties for noncompliance.

    Our attorneys are uniquely qualified to help employers determine: (1) how they and their affiliates must comply with the ACA; and (2) steps they should take to comply with the law’s provisions if compliance is required.

    We conduct business practice and employee benefit audits to determine what modifications an employer must make to ensure compliance with the ACA.

    Our distinct strengths include:
    • Options for providing healthcare coverage
    • W-2 reporting requirements
    • Corporate restructuring and due diligence issues concerning business acquisitions
    • Tax reporting and guidance
    • Benefit compliance issues
    • Employment/whistleblower claims arising under the ACA
    • Expanded wage and hour liability
    • Extended health plan/ERISA reporting and design obligations
  • ANTITRUST COUNSELING AND DEFENSE

    LeClairRyan’s antitrust attorneys represent healthcare providers and pharmaceutical companies of all types and sizes at federal and state levels and in a variety of antitrust and trade-regulation cases, including civil and criminal litigation and investigations and enforcement actions by the Federal Trade Commission, U.S. Department of Justice and state Attorneys General’s offices.

    We counsel clients on joint ventures, mergers and acquisitions, Hart-Scott-Rodino filings, regulatory compliance, and many other antitrust-related issues. We also help our clients make sure their current and contemplated business practices adhere to antitrust laws such as the Sherman Act and Robinson-Patman Act of 1936.

    Representative Matters

    • Representing a Florida hospital involved in a merger with a urology practice in an FTC investigation for antitrust
    • Representing a hospital system that is purchasing an oncology practice in an investigation by the FTC Health Care Services and Products Division
    • Represented a physician who was denied privileges at a hospital and sued under the Sherman Antitrust Act and Virginia antitrust statutes
    • Successfully represented large pharmaceutical company regarding the Federal Trade Commission’s informal request for additional information through a “Voluntary Access Letter,” and won early termination of the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
  • ACADEMIC MEDICINE AND CLINICAL RESEARCH

    Members of our Healthcare industry team possess a depth of experience related to the issues pertaining to academic medicine, including:

    • Clinical research regulations
    • Clinical research outsourcing
    • Clinical trial strategies and agreements
    • Environmental concerns (such as the handling of medical waste)
    • Off-label use of drugs and devices
    • Products’ health-related claims
    • Intellectual property rights
    • Technology transfers
  • ADMINISTRATIVE CREDENTIALING, PEER REVIEW AND LICENSURE

    LeClairRyan’s healthcare attorneys regularly handle issues related to administrative credentialing, peer review and licensure, including:

    • Preparing and revising medical staff bylaws, rules and regulations, and policies and procedures
    • Peer reviews, hearings and appellate reviews
    • Credentialing practices
    • Telemedicine issues
    • Individual physician credentialing issues and disputes
    • National Practitioner Data Bank and reporting of state board disciplinary matters
    • Representing individual providers before state disciplinary boards
    • Investigations and administrative proceedings by state licensing boards

    Representative Matters

    • Defended and negotiated complex consent decree for dermatologist accused of over-reading pathology slides and thereby over-diagnosing and treating skin cancers
    • Obtained dismissal for psychologist accused of sexual misconduct with patient in psychiatric hospital
    • Obtained dismissal for psychiatrist accused of improperly prescribing psychotropic medication
    • Represented family practice physician in an OPMC (Office of Professional Medical Conduct, New York State Department of Health) claim requesting the physician surrender his license over allegations of committing malpractice on more than one occasion and failure to keep accurate documentation
    • Represented numerous hospital physicians, dentists, and oral surgeons in New York and New Jersey, where records were provided and telephone interviews were conducted but no further action was taken, in complaints regarding discrimination, patient dumping, fraud, and malpractice
    • Advise medical board of a New York hospital in terminating several emergency room physicians after drafting due process documents in compliance with hospital bylaws and HCQIA
    • Represented national healthcare system when its outpatient radiological technicians received “cease and desist” letters for practicing without state licensure despite a state law exempting technicians from licensure when practicing for a provider holding a hospital license. Radiology services for several thousand Virginians were at stake.
    • Represented hospital during investigation by state agency stemming from a purported sexual encounter between mentally-retarded patient and geriatric patient on psych unit. Issues involved patient monitoring, use of restraints, patient rights, police involvement, and timely reporting to agency
    • Represented surgeon accused of failing to adequately follow a patient after gastric bypass surgery leading to patient’s death
    • Represented nursing home during a state/Medicare survey that threatened to close the facility
    • Represented psychiatrist accused of allowing a patient to self-direct her pain management care
    • Represented obstetrician who was trying to keep his hospital privileges after the hospital accused him of being disruptive
    • Represented ENT physician who was chastised for his perceived lack of decorum around women at a Virginia community hospital
    • Represented gynecologist at two Virginia hospitals in matters relating to issues involving his surgical complication rates
    • Represented orthopedic surgeon who refused to provide pain medications post-surgery for patient already receiving pain medications by another provider
    • Represented ophthalmologist in claim resulting in a no violations finding, in a matter alleging a patient’s glaucoma pressures increased significantly causing partial blindness during the performance of cataract surgery
    • Represented urologist in claim resulting in no violation finding, after prostatectomy complication allegedly led to permanent fistula between bladder and rectum
    • Represented physician assistant who voluntarily sought counseling for stress and was found not to be a danger to patients and not in need of health provider monitoring program in Board of Medicine claim
    • Represented client in Board of Nursing allegations resulting in no violation finding regarding the possible over-medication of patient with PCA pump pain medications death case resulting in no violation finding
  • BANKRUPTCY AND CORPORATE REORGANIZATION

    As a “one-stop shop” with experience in all areas of bankruptcy law – from dealing with the minutiae of Chapter 11 of the Bankruptcy Code to working with the big-picture strategic realities of multinational banks and corporations – LeClairRyan’s Bankruptcy and Creditors’ Rights team is well-positioned to obtain optimum results for our healthcare clients.

    Our distinctive strengths related to the healthcare industry include:

    • Business debtor representation and financial restructuring
    • Unsecured creditor representation
    • Out-of-court workouts and creditors’ rights
    • State law collection proceedings
    • Bankruptcy litigation
    • Receiverships
    • Foreclosures

    When appropriate, we work in concert with LeClairRyan attorneys in related practice areas, including securities, real estate, corporate services, taxation, intellectual property, business litigation, environment, and labor and employment. This collaborative approach enhances our ability to provide our healthcare clients with effective representation while reducing costs and preserving value.

    Representative Matters

    • R.J. Reynolds, Patrick County Community Hospital: representation of community hospital in sale of substantially all assets while ensuring continuation of patient care and compliance with applicable regulations governing medical services provider
    • Anesthesia Solutions, Inc.: special litigation counsel handling various breach of contract matters
    • Represented group health plan in successfully obtaining equitable lien on proceeds of debtor’s personal injury claim for benefits received by debtor from health plan (In re: Tina L. Carpenter, 252 B.R. 905 (E.D. Va. 2000)).
    • Served as counsel, indenture trustee, In re: Revco D.S., Inc. and Tidewater Memorial Hospital, Inc.
    • Served as debtor’s counsel for large multi-practice physician groups in its out of court restructuring
    • Served as debtor’s counsel for continuing care facility
    • Handled various creditor/contract issues for rehabilitation facility and physical therapists
  • COMPLIANCE COUNSELING AND DEFENSE

    One of the most effective ways to protect the enterprise is to prevent problems and liabilities before they occur. To that end, our attorneys regularly advise our healthcare clients on fraud and abuse and other regulatory issues, including risk assessments, to avoid situations that might lead to government investigations or other litigation.

    We develop compliance programs for our healthcare clients and work with them to implement and enhance such programs. As part of our work in this area, we have negotiated Corporate Integrity Agreements with the U.S. Department of Health and Human Services’ Office of Inspector General and assisted clients with fulfilling their obligations under such agreements.


    Our healthcare team provides clients with legal counsel and representation on matters related to compliance, including:

    • Codes of conduct
    • Conflicts of interest
    • Physician compensation
    • Physician incentives (including those related to ePrescribing and the Physician Quality Reporting Initiative)
    • Billing, coding and collection
    • HIPAA and HITECH compliance
    • EMTALA compliance
    • Compliance audits (including those related to Stark Law, Anti-Kickback Statute, False Claims Act, and Medicare/Medicaid conditions of participation)
    • Prepare, revise and monitor Plans of Correction to Statements of Deficiency
    • Marketing, sales and promotional practices, including drug off-label promotion and provider remuneration and entertainment
    • Provider enrollment and certification
    • Reporting and voluntary disclosures under Medicare, Medicaid, and SCHIP
    • Internal investigations related to regulatory, policy and contractual matters
    • Governmental fraud and abuse investigations
  • CIVIL LITIGATION

    LeClairRyan’s deep bench of veteran litigators provide healthcare clients with legal counsel and representation a full-spectrum of civil litigation, including the defense of claims related to:

    • Medical device and pharmaceutical products liability
    • Antitrust claims
    • Business fraud
    • Conspiracy
    • Tortious interference with contract
    • Breach of fiduciary duty
    • Unfair competition claims 
    • Contract and covenant not-to-compete claims
    • Corporate dissolutions
    • Shareholder disputes and corporate control cases
    • Defamation
    • Intellectual property disputes
    • Statutory claims

    Representative Matters

    • Represented general counsel of a public company in the medical services business in a putative class action lawsuit filed by a number of hospitals alleging overcharging for services, and in concurrent investigations by the SEC and the Department of Justice
    • Advised chief executive officer of a publicly-traded insurance company in connection with Medicare fraud litigation pending against the company
    • Handled civil litigation involving corporate licensing and government issues
    • Obtained “no cause” jury verdict on claims of breach of medical practice shareholder agreement
    • Handled civil and criminal litigation involving the interpretation of California law with regard to physical therapy and Med-X treatment
    • Handled civil litigation involving defense of treatment of Lyme disease by IV infusing for longer terms and dealing with the challenges associated with this treatment
    • Handled contract dispute involving the delay of delivery of drugs to hospitals in the mid-Atlantic region. Obtained summary judgment on numerous discovery matters and dismissal of several counts in the complaint.
    • Represented a medical device manufacturer in a five-week trial of products liability claims for a design defect and breach of warranty concerning an instrument used to introduce a heart surgery catheter. The patient sustained an air embolism leading to a persistent vegetative state condition when the device allegedly separated in the ICU. The product was found "not defective" after a multimillion-dollar settlement during trial by codefendant hospital, doctors, and ICU nurses.
    • Serve as longstanding national e-discovery counsel to pharmaceutical manufacturers in a wide range of class action and individual products liability lawsuits
    • Successful prosecution of liability claims in an arbitration pertaining to agreement governing transfer of patent rights
    • Successful representation of domestic health insurer in a series of breach of contract and unfair business practices lawsuits brought by hospitals
    • Represented regional hospital in the termination for cause and arbitration of various contract disputes under an IT services outsourcing agreement
    • Arbitration trial of claims seeking enforcement of covenant not to compete against over-the-counter medical product distributor
    • Represented physicians merging with group practice
    • Represented and advised a regional hospital in various claims and disputes with outsourcing vendor and subsequent termination “for cause” of its existing IT services outsourcing agreement
  • CLASS ACTIONS

    LeClairRyan's team of veteran class action litigators understands and appreciates the far-reaching implications of such matters and works closely with domestic and international businesses to strategically and efficiently minimize their exposure. Our proactive approach coupled with our keen business acumen consistently yield favorable and quantifiable results for class action clients across the nation.

    Our attorneys conduct early case assessments and craft cost-effective solutions best suited to our clients' business and legal needs, whether it entails litigating through trial, reaching an agreement through arbitration, or resolving a matter before trial. We carefully consider the client's business goals and future success when shaping and implementing a legal strategy.

    Our track record speaks for itself – we are well respected for our proven ability to derail class actions by opposing class certification and dismissing claims at the motion to dismiss stage of litigation. With attorneys from coast to coast who are admitted in over 25 jurisdictions, we possess a depth of experience managing multidistrict and class action claims.

    We have represented some of the nation's most well known businesses across a spectrum of industries on issues including:

    • Medical and dental devices
    • Pharmaceuticals
    • Labor and employment practices
    • Business practices
    • Information handling and disclosure
    • Manufactured consumer products, including genetically modified foods
    • Manufactured commercial products
    • Securities and shareholder derivative actions
    • Consumer financial services
    • Corporate financial services
    • Retail sales and services
    • Media and technology
    • Banking processes and services

    Even though class action litigation is subject to a largely consistent legal process, our attorneys value the necessity of a holistic planning approach, taking into account: (1) the client and its brand; (2) the company's internal goals, processes and relationships; (3) the potential effect of the litigation on the client's industry; (4) the products, services or processes at issue; and (5) the applicable legal practices.

    Our attorneys also are skilled at representing businesses in the government investigations that often occur as a result of class action litigation. We have long demonstrated our ability to efficiently manage the work associated with class action litigation as well as a related government investigation without developing a prejudice that would impair our ability to succeed in either matter. We also stay abreast of pertinent emerging trends such as recent decisions regarding class action waiver and arbitration provisions, allowing us to consistently provide clients with uncompromised legal counsel.

    Class Action Litigation Discovery

    LeClairRyan possesses the experience and depth necessary to help businesses involved in class action litigation navigate all aspects of modern discovery. We offer clients a strategically leveraged combination of skilled professionals, secure processes and cutting-edge technologies.
    Our discovery professionals are skilled at collecting and reviewing voluminous amounts of electronic and paper documents that are often associated with class action litigation. In addition, we routinely help clients organize their business and record-keeping processes, enabling them to better align with the legal and regulatory requirements that come to bear during litigation.

    Representative Matters

    • Serve as longstanding national e-discovery counsel to pharmaceutical manufacturers in a wide range of class action and individual products liability lawsuits
    • Represented general counsel of a public company in the medical services business in a putative class action lawsuit filed by a number of hospitals alleging overcharging for services, and in concurrent investigations by the SEC and the Department of Justice
    • Handled large e-discovery projects in latex medical glove and medical insurance hospital discount litigation
  • CORPORATE FINANCING

    LeClairRyan’s corporate attorneys offer a wide variety of legal services designed to foster the growth and development of our healthcare clients, including:

    • Initial and secondary public offerings
    • Private placements
    • Venture capital finance
    • Public finance
    • Convertible and straight debt offerings
    • Common and preferred stock offerings
    • Debt and equity financings
    • Issuance of revenue bonds and tax-exempt bonds
    • SEC compliance and reporting
    • Mergers, acquisitions, and divestitures
    • Management buyouts
    • Real estate syndications
    • Sale-leaseback arrangements
    • International joint ventures
    • Corporate governance
    • General corporate and partnership law
    • Federal and state securities regulation
  • CORPORATE TRANSACTIONS AND AGREEMENTS

    Knowing that legally sound contracts are a key component of a strong healthcare business, our team members take every step to ensure we protect our clients’ best interests when negotiating, drafting and managing contracts as well as handling issues that arise as a result of such agreements. We also provide legal representation to our healthcare clients when litigation pertaining to a transaction or agreement arises.

    Our distinctive strengths include transactions and agreements supporting:

    • Joint ventures
    • Partnerships
    • Service providers
    • Buy-sell deals
    • Suppliers
    • Vendors
    • Distribution
    • Information technology systems development and services
    • Information technology outsourcing
    • Computer systems and data processing
    • Licenses
    • Financing
    • Franchises
    • Real estate sales and leases
    • Equipment leasing and acquisition
    • Employment and severance agreements
    • Manufacturing agreements
    • Maintenance agreements
    • Aircraft leases and sales
    • Aircraft management
    • Contract dispute resolution and litigation
  • DRUG AND DEVICE (FDA) APPROVALS AND COMPLIANCE

    LeClairRyan’s Food and Drug Law practice covers every aspect of food and drug regulatory law in the United States, including all matters within the Food and Drug Administration’s (FDA) regulatory purview, from clinical trials and drug development through the FDA review process to pharmacovigilance and other post-market requirements. We provide regulatory advice to a variety of pharmaceutical, biotechnology, durable medical equipment, and medical device companies.

    Our Food and Drug Law attorneys represent clients before the FDA, Federal Trade Commission (FTC), and United States Department of Agriculture (USDA), as well as in litigation at all federal court levels. In addition, our team members have represented numerous clients in food and drug law matters. We represent clients in each of the product categories regulated by FDA and USDA, including:

    • Human pharmaceuticals
    • Medical devices
    • Radiological products
    • Human biological products
    • Cosmetics
    • Food and dietary supplements
    • Food and beverage law
    • Hatch-Waxman issues
    • Biosimilars
    • Health information and privacy compliance
    • Consumer product safety regulation
    • Legislative advocacy

    We also advise pharmaceutical and device manufacturers and other healthcare providers on matters related to Medicare and Medicaid, including obtaining favorable Medicare coverage and reimbursement, Medicaid drug rebate requirements, contractor audits, and compliance with the Medicare Anti-Fraud and Abuse Act.

    Our in-depth knowledge of the inner workings of the FDA and the Centers for Medicare and Medicaid Services enables us to assist our clients in developing optimal strategies for product development, approval and reimbursement. In appropriate circumstances, these strategies may include a legislative component, developed in collaboration with the firm’s Government Relations practice.

  • ENVIRONMENTAL LAW IN HEALTHCARE

    LeClairRyan environmental law attorneys represent public and private healthcare clients in all aspects of environmental permitting, compliance, transactional due diligence, and dispute resolution related to issues such as:

    • Air emissions from boilers and incinerators
    • Underground storage tanks
    • Management of medical, chemical and other hazardous waste
    • Wastewater treatment and disposal
    • Medical waste incinerator permitting
    • OSHA workplace regulations
    • Indoor air quality
  • FRAUD AND ABUSE COUNSELING AND DEFENSE

    Our attorneys regularly represent many entities, including pharmaceutical companies, medical device and equipment companies, clinical laboratories, hospitals, nursing homes and long-term care facilities, as well as individual officers and employees of such companies in a variety of matters involving allegations of fraud and abuse violations. These matters pertain to:

    • Federal and state government investigations and inquiries
    • Internal investigations and corporate compliance
    • Civil and administrative enforcement proceedings, such as actions under the False Claims Act and state counterparts (including qui tam actions)
    • State consumer fraud and deceptive practices statutes
    • Deceptive practices and class action cases brought by state Attorneys General’s Offices or private plaintiffs
    • Alleged violations of the Stark Law and Anti-Kickback Statute, the Food, Drug and Cosmetic Act, Federal False Claims Act and Fraud Enforcement and Recovery Act of 2009, and Foreign Corrupt Practices Act
    • Federal Trade Commission actions
    • Manufacturing practices laws and regulations (e.g., the manufacturing of products regulated by the Food and Drug Administration)
    • Regulations governing federal and state price reporting (e.g., the Medicaid Drug Rebate Program)
    • Marketing, sales and promotional practices, including off-label promotion and physician remuneration and entertainment
    • Research and educational grants
    • Clinical research fraud
    • Continuing medical education
    • Health insurance

    Increasingly, companies under government investigation must simultaneously manage a criminal grand jury investigation, related civil investigation or ongoing civil litigation by the government, congressional inquiry, and private civil litigation. Such situations require careful management of these parallel proceedings to ensure the best possible outcome for our clients.

    Our attorneys have extensive knowledge of the sometimes competing and conflicting interests that arise during government investigations, and our team includes several former federal prosecutors and government lawyers who have valuable experience and insights into the investigation and prosecution of these matters. As a result, we have successfully resolved criminal investigations with no criminal charges against our clients and litigated numerous cases brought under the qui tam provisions of the False Claims Act.

    In recent years, the U.S. Department of Justice and U.S. Securities and Exchange Commission have placed an increased emphasis on compliance with the Foreign Corrupt Practices Act (FCPA), particularly within the healthcare industry. Expanded government oversight as well as new whistleblower protections compound the level of complexity under which healthcare enterprises operate.

    LeClairRyan regularly helps healthcare companies navigate the complex legal environment that regulates their operations. We represent public and private healthcare companies in matters related to all aspects of FCPA compliance, including transactional due diligence, internal investigations and the defense of governmental enforcement actions.

    Risk Management and Corporate Compliance

    One of the most effective ways to protect the enterprise is to prevent problems and liabilities before they occur. To that end, our attorneys regularly advise our healthcare clients on fraud and abuse and other regulatory issues, including risk assessments, to avoid situations that might lead to government investigations or other litigation.

    We also develop compliance programs for our healthcare clients and work with them to implement and enhance such programs. As part of our work in this area, we have negotiated Corporate Integrity Agreements with the U.S. Department of Health and Human Services’ Office of Inspector General and assisted clients with fulfilling their obligations under such agreements.

    Representative Matters

    • Represented healthcare product manufacturing company during FTC and FDA investigations regarding alleged improper claims of products
    • Defended national healthcare provider in the largest healthcare fraud case for billing fraud violations in the country. Case involved numerous qui tam matters filed in various district courts and involved the review of millions of documents, hundreds of depositions, numerous court hearings, pretrial motions, etc. After five years of responding to grand jury and civil subpoenas and extensive pretrial work, obtained a settlement with the qui tam creditors, the U.S. Department of Justice and client for approximately $800 million, avoided exclusion and minimized criminal indictments.
    • Defended two major hospitals in federal qui tam suits
    • Represented large hospital in connection with allegations of fraud in reported results of clinical trials
    • Acted as lead trial counsel in the largest Medicare and Medicaid healthcare carrier case in the U.S. Recovered damages of $144 million for the Federal Insurance Fund.
    • Defended hospital group in billing fraud case involving numerous qui tam matters filed in various district courts and the review of millions of documents, hundreds of depositions, numerous court hearings, pretrial motions, etc.
    • Defended and investigated procedures by U.S. Department of Justice for billing irregularity issues. Extensive discovery and arguments to grand jury and civil subpoena, deposition, etc. Prevented exclusions and minimized damages to client.
    • Assisted in the investigation and plea negotiation in one of the largest medical device fraud cases in the state of Virginia
    • Assisted healthcare providers in responding to requests from audit contractors for further billing documentation, retaining bill coding and accounting experts as necessary
    • Represented healthcare providers in state Attorneys General’s investigations of alleged Medicaid fraud
    • Represented municipalities against alleged Medicaid overpayments, negotiating a repayment process
    • Counseled durable medical equipment and home health equipment suppliers on compliance with Medicare and Medicaid requirements pertaining to the sale and distribution of products as well as on service agreements with equipment providers
    • Represented nutraceutical companies during FTC and FDA investigations regarding alleged improper claims of products
  • GOVERNMENT INVESTIGATIONS

    LeClairRyan regularly helps healthcare companies navigate the complex legal environment that regulates their operations. We represent public and private healthcare companies in matters related to all aspects of regulatory compliance, including transactional due diligence, internal investigations and the defense of governmental enforcement actions.

    Risk Management and Corporate Compliance

    One of the most effective ways to protect the enterprise is to prevent problems and liabilities before they occur. To that end, our attorneys regularly advise our healthcare clients on fraud and abuse and other regulatory issues, including risk assessments, to avoid situations that might lead to government investigations or other litigation.

    We also develop compliance programs for our healthcare clients and work with them to implement and enhance such programs. As part of our work in this area, we have negotiated Corporate Integrity Agreements with the U.S. Department of Health and Human Services’ Office of Inspector General and assisted clients with fulfilling their obligations under such agreements.

    Representative Matters

    • Represented healthcare product manufacturing company during FTC and FDA investigations regarding alleged improper claims of products
    • Defended hospital group in a large healthcare fraud case for billing fraud violations. Case involved numerous qui tam matters filed in various district courts and involved the review of millions of documents, hundreds of depositions, numerous court hearings, pretrial motions, etc.
    • Defended two major hospitals in federal qui tam suits
    • Represented large hospital in connection with allegations of fraud in reported results of clinical trials
    • Defended and investigated procedures by Department of Justice for billing irregularity issues. Extensive discovery and arguments to grand jury and civil subpoena, deposition, etc. Prevented exclusions and minimized damages to client.
    • Handled case involving challenge by the state of Washington and the Washington State Board of Pharmacy involving the sale of human growth hormones for the treatment of various illnesses
  • GOVERNMENT CONTRACTS AND PROCUREMENT

    The attorneys on LeClairRyan’s Government Contracts team have deep experience in all areas of this highly regulated and often strategically critical area of practice. Whether at the federal, state, or local level, we routinely assist clients with the procurement, administration and regulation of government contracts, as well as with mediation, arbitration and litigation of those processes when necessary. Indeed, close coordination with LeClairRyan attorneys from other practice teams – colleagues focused on corporate law, securities, government relations, technology, intellectual property, financing, employment, taxation, immigration, litigation, bankruptcy and more – puts our Government Contracts team in an optimal position to effectively meet our clients' needs.

    Our attorneys frequently provide legal advice tailored to our clients' individual business priorities. We serve as advisors in explaining the legal framework to our clients, as counselors in helping them develop appropriate business processes, including compliance programs, and as advocates when the need to resolve matters before a tribunal is required. Regardless of the task at hand, we offer effective solutions that directly translate into business value.

    Our Government Contracts team has experience in the following areas:

    • Procurement, administration and compliance
    • Bid protests
    • Program modification and termination
    • Litigation
    • Governmental inquiries and investigations
    • Business formation and transactions
    • Intellectual property
    • Local and state government contract matters
    • Employment, labor and immigration
    • Import/export issues
  • HEALTHCARE OPERATIONS

    LeClairRyan offers our healthcare clients legal guidance and representation in all matters related to operating a healthcare organization or business.

    Our distinctive strengths include:

    • Patient rights (e.g., bioethics, informed consent, guardianships, access to medical records, end of life legal matters)
    • Medical staff policies and procedures
    • Administrative credentialing and peer review
    • Performance improvement
    • Risk management (e.g., professional liability, premises liability, occupational and environmental safety, ADA compliance pertaining to public access, employment regulatory compliance)
    • Licensing and accreditation
    • Certificate of need applications
    • Staff training (e.g., clinical documentation, malpractice avoidance, responding to litigation and investigations)
  • HEALTH INFORMATION PRIVACY AND SECURITY

    LeClairRyan offers our healthcare clients a multidisciplinary team of attorneys focused on privacy, data protection, information security, software licensing and computer security law, including requirements under the Gramm-Leach-Bliley Act, Health Insurance Portability and Accountability Act, and other federal and state laws.

    Our distinctive strengths include:

    • Technology vendor selection, RFP development and implementation
    • Software license negotiation
    • Clinical, ancillary, financial, billing and operational systems, including EHRs, LIS, RIS
    • “Meaningful use” incentive payments
    • Equipment acquisition (purchased and leased)
    • Licensing of cloud computing applications and platforms
    • Telecommunications products, services and network agreements
    • Maintenance and support agreements
    • IT outsourcing agreements
    • Policies and workflow procedures pertaining to HIPAA and HITECH
    • Healthcare informatics
  • IMMIGRATION

    There are numerous ways in which non-U.S. citizen workers can be placed in positions with domestic U.S. healthcare companies and organizations, and it is therefore critical that the most appropriate and cost-effective paths be identified and taken. LeClairRyan’s Immigration and Naturalization team has the knowledge and experience to secure the proper type of work visa/permit solution with respect to clients’ long- and short-term goals. Furthermore, we offer our clients direct and easy access to an online case-management system so that they can track the real-time progress of their cases.

    Often, the most appropriate initial path for non-U.S. residents is to obtain temporary status, with a subsequent transition to permanent status as needed. With proper foresight, this can be done smoothly and efficiently. There are numerous categories of temporary nonimmigrant visas, each with various sets of qualifiers, specifications and requirements. We are thoroughly versed with each type and will identify the most appropriate solution. The various nonimmigrant temporary visa types include:

    • J-1 waivers and H1-B visas for medical professionals and academic personnel
    • H1-B visas for degreed professionals
    • O-1 for individuals with outstanding abilities
    • B-1 business visitor visas
    • E1/E2 treaty trader & investor visas
    • L1-A/L1-B multinational employees
    • Treaty NAFTA (TN) visas
    • J-1 and H-3 trainees

    Our attorneys also provide legal counsel and representation in immigration matters related to compliance, family sponsorship, naturalization and litigation.

    Representative Matters

    • Serve as exclusive U.S. immigration counsel for a European-based pharmaceutical company, assisting in transferring key executives and technical employees from Europe to the U.S.
    • Represent many physicians and other healthcare workers seeking employment opportunities in the U.S.
    • Serve as immigration counsel to medical college for faculty and students
  • INFORMATION TECHNOLOGY AND ELECTRONIC HEALTH RECORDS

    The ongoing effort to move the nation’s healthcare system away from paper and toward Electronic Health Records (EHR) promises to yield substantial savings over the long term. Because it is in its earliest stages, however, the EHR adoption process remains fraught with potential legal and financial risk. The veteran attorneys on LeClairRyan’s EHR practice team are steeped in the complexities of EHR—from maintaining privacy and security on data networks and the Web, to seeking to steer medical practices away from systems and technologies that are likely to become non-compliant or obsolete.

    Our attorneys are well-positioned to help medical practices take full advantage of the existing $35 billion in EHR incentives now available through the federal Centers for Medicare & Medicaid Services. Those provisions, which allow doctors to apply for and obtain up to an aggregate of $44,000 EHR-implementation incentives per individual physician [designed to encourage early adoption by front-loading $18,000 for EHR use in 2011 or 2012, then $12,000; $8,000; $4,000 and $2,000 in each subsequent year and expire in 2015. Thereafter, customary reimbursement rates are scheduled to fall precipitously for practices that have failed to embrace EHR by the 2015 deadline.

    Meanwhile, LeClairRyan attorneys are closely following day-to-day developments in the raft of EHR-related provisions in the Obama administration’s healthcare reform package. Our attorneys will continue to track all EHR-related trends and proposed or enacted regulations in order to keep our clients ahead of the curve in this fast-developing area. Regardless of the eventual shape of this healthcare reform legislation, these EHR incentive grants are enacted, are fully funded and are available to healthcare providers now.

    Uncertainties in the EHR-adoption process can be as basic as what exactly regulators mean when they call for a “meaningful” adoption of the technology. And, as many physicians have already learned, EHR technology vendors often work with standard, one-size-fits-all contracts that give physicians no recourse if the technology they invest in later becomes obsolete or non-compliant. Our attorneys are adept at winning flexible commercial contracts that help physicians and CIOs to stop worrying about EHR implementation and focus on what they do best—healing patients.

  • INTELLECTUAL PROPERTY

    LeClairRyan offers a comprehensive national and international intellectual property and technology practice that enables our healthcare clients to protect and maximize the value of their intellectual property rights. Our team of attorneys, patent agents, and Ph.D. technical specialists offer a full range of intellectual property legal services, including:

    • Preparing and prosecuting patent applications
    • Post-issuance patent practice, including patent interferences, reexaminations, reissues and oppositions, with such proceedings taking place separately, together or in conjunction with litigation
    • Inventorship evaluations, opinions and litigation
    • Intellectual property counseling, opinions and strategy services
    • Litigation of patent, copyright, trademark, trade secret, and licensing and technology contract disputes nationally and internationally
    • International patent prosecution and patent enforcement
    • Intellectual property audits and due diligence
    • Drafting and negotiation of intellectual property licenses and technology agreements, including joint venture and technology transfer agreements
    • Trademark clearance, prosecution and licensing
    • Copyright registration and counseling
    • Electronic health records (EHR) systems
    • Acquisition of information technology and telecommunications products and services
    • Licensing of software, cloud computing applications and platforms
    • Information technology and telecommunications outsourcing agreements
    • Media and internet-related advice and counseling, including privacy, immunity, data breaches, web-based agreements, and First Amendment-related advice and litigation
  • INTERNATIONAL HEALTHCARE COMPANY COUNSELING AND DEFENSE

    LeClairRyan represents European and other international clients in venues throughout the United States in complex proceedings involving disputed jurisdiction, choice of law, forum disputes, and disputed arbitration clauses. We serve clients in a variety of contexts, including joint ventures, acquisitions, franchise agreements, distribution agreements, and other business relationships.

    Our attorneys are frequently called upon to provide information, advice and testimony on issues related to U.S. law in courts throughout Europe and partner with experienced European attorneys to provide opinions regarding international matters pertinent to U.S. proceedings. Our team is adept at resolving issues of jurisdiction, conflicts of law and forum non conveniens. We are well-versed in conducting U.S. discovery throughout the world, as well as pursuing actions in the U.S. to obtain discovery relevant to foreign proceedings.

    As a team, our knowledge and experience in international litigation and dispute resolution enables us to offer highly capable guidance and representation to clients in a variety of industries and in diverse legal matters ranging from international business transactions and contract matters to intellectual property disputes and complex environmental remediation claims.

    International Corporate Transactions

    LeClairRyan's International Law attorneys assist domestic and foreign-based clients in negotiating, structuring and implementing strategic corporate and commercial transactions and day-to-day operations.

    Our clients range in size from individual entrepreneurs and start-up companies to multinational corporations in a variety of industries, including healthcare, commercial, investment and merchant banking, manufacturing, hospitality, food and beverage, logistics, distribution, real estate, media, equipment leasing, and consulting.

    In-bound Operational Matters

    Our firm represents many foreign-based companies with respect to their United States operations, including:

    • Mergers, acquisitions, dispositions, financings and recapitalizations
    • Formation and administration of closely-held corporations, limited liability companies, joint ventures, partnerships, funds, and technology and distribution start-ups
    • Leasing and off-balance sheet financings
    • Domestic and international sale of goods and services
    • Employer/employee and non-competition matters
    • Franchising and distributorships
    • Immigration planning and implementation
    • Corporate and individual tax planning and implementation

    Domestic and International Corporate and Dispute Resolution Strategies

    In addition to LeClairRyan's corporate transaction experience, our firm also has a depth of experience representing businesses in state and federal courts nationwide, in the United States Supreme Court, and in international courts and tribunals. We frequently develop dispute resolution strategies for clients in matters related to business law, employment law, intellectual property, and patent, trademark and copyright infringement. We also advise lenders in the prosecution and defense of lender liability and business fraud claims as well as in regulatory and fraud prevention matters.

  • LABOR AND EMPLOYMENT

    LeClairRyan’s attorneys possess the knowledge and experience necessary to help healthcare organizations and businesses navigate the myriad of labor and employment issues they face on a daily basis.

    Our distinctive strengths include:

    • Employment agreements and severance agreements
    • Compensation and benefits
    • Contract negotiation and collective bargaining
    • Representation of employers in wrongful discharge actions
    • Preparation of employee handbooks and policies
    • Federal and state regulatory compliance
    • Independent contractor vs. employee matters
    • Immigration issues
    • Employee complaints
    • Investigations
    • Alternative dispute resolution
    • Litigation

    Representative Matters

    • Obtained dismissal of employment discrimination matter against regional hospital after nine days of trial. Employee terminated after department no longer able to accommodate her after carpel tunnel and lateral epicondylitis disabled her from essential functions of job. Plaintiff claimed discrimination in violation of Title VII, race, and the Americans with Disabilities Act and corresponding state statutes. Case dismissed to Human Rights Referee.
    • Obtained judgment for defendant after 22 days of evidence in matter alleging breach of implied and express contracts, fraud, promissory estoppel, tortious interference with contract against each individual defendant, intentional and negligent infliction of emotional distress, race discrimination, and retaliation. Defendants were the hospital employer, a physician supervisor, and a human resources officer of the hospital.
    • Obtained per curiam opinion in appellate court affirming and adopting judge’s opinion in above representative matter.
  • MANAGED CARE

    LeClairRyan’s healthcare attorneys possess the depth and breadth of experience necessary to help managed care organizations navigate the operational and regulatory issues specific to their businesses.

    Our distinctive strengths include:

    • Managed care organization development
    • Managed care contract negotiations
    • Integrated delivery systems
    • Managed care payment structures
    • Third-party payors
    • Mergers and acquisitions
    • Licensure applications
    • Service contracts
    • Employment contracts
    • Leases and real estate acquisitions and sales
    • Regulatory compliance and investigations
    • Alternative dispute resolution
    • Litigation
  • MEDICARE, MEDICAID AND PRIVATE INSURER COMPLIANCE

    Managing third-party coverage and payment issues in the healthcare industry is a complex and daunting task. LeClairRyan is strategically positioned to provide the necessary legal guidance and representation in all matters related to Medicare, Medicaid and private insurer compliance.

    Our distinctive strengths include:

    • Audits
    • Eligibility compliance
    • Provider enrollment and certification
    • Coding and billing compliance
    • Rate setting
    • Physician incentives, including ePrescribing and Physician Quality Reporting Initiative Reporting under State Children’s Health Insurance Program (SCHIP) and Medicare, Medicaid, and SCHIP Extension Act
    • Payment denials and overpayment determinations
    • Reimbursement issues
    • State facility licenses and certificates of need
    • Pharmaceutical rebates and discounts
    • Coverage, payments and coding issues related to new drugs, devices and services
    • Representation at state and federal levels
    • Regulatory compliance
    • Due diligence
  • MERGERS AND ACQUISITIONS AND DIVESTURES

    LeClairRyan represents domestic and international buyers and sellers, both public and private, in a broad range of transactions encompassing virtually all industry groups, including healthcare, banking and financial services, manufacturing, retailing, utilities, service-based companies, and technology firms.

    Our approach to client representation is team-oriented and draws on the extensive and diverse experience of our attorneys in other practice areas at LeClairRyan when needed. Our deep bench includes attorneys who focus on securities, tax issues, real estate law, employee benefits, labor and employment law and regulations, bankruptcy proceedings, international trade, intellectual property rights, environmental law, and administrative law.

    Our distinctive healthcare merger, acquisition and divesture strengths:

    • Purchase and sale of businesses
    • Formation of medical practices
    • Stockholder agreements, including buy-sell agreements
    • Succession planning
    • Joint ventures
    • Taxable and tax exempt capital, debt and lease financing
    • Real estate leases, acquisitions and sales

    In all our buying, selling, and merger engagements with clients, we work closely with management from start to finish, and we assist in all aspects of the transaction. Our services include:

    • Making client introductions to potential service providers, investment bankers, lenders, and other strategic partners
    • Providing advice on and developing transaction structures that best align with the client’s business objectives
    • Drafting and negotiating transaction terms, letters of intent, and all transaction documents
    • Assisting in due diligence investigations and advising on any substantive issues that might arise in the course of such investigations
    • Closing the transaction
    • Performing various functions related to the transaction subsequent to the closing, including completion of all required federal, state, and local government filings
    • Providing ongoing advice after the closing on operational matters (for buyers) and tax and estate-planning strategies (for sellers)
  • PRIVATE EQUITY

    Our team members who focus on private equity offer a wide range of services in areas of law critical to the development and growth of all types of business clients, both large and small. LeClairRyan has a long history of involvement and a distinguished reputation in this area of corporate securities and has worked with numerous private equity firms, venture capital firms and angel investors interested in nurturing the growth of various healthcare companies.

    Our distinctive private equity strengths include:

    • Leveraged buyouts
    • Venture capital financings
    • Growth capital
    • Distressed investments
    • Mezzanine capital
  • REGULATORY COMPLIANCE

    Healthcare continues to be one of the most challenging areas of business due to increasing government regulation and enforcement. Members of LeClairRyan's Healthcare Investigation and Litigation Practice are well qualified to assist clients in managing the risks of conducting business in this environment and providing defense against any adverse occurrences.

    Our attorneys regularly represent healthcare entities, including pharmaceutical companies, medical device and equipment companies, clinical laboratories, hospitals, nursing homes and long-term care facilities, as well as individual officers and employees of such companies in a variety of matters involving allegations of healthcare fraud and abuse. These matters pertain to:

    • Federal and state government investigations and inquiries
    • Internal investigations and corporate compliance
    • Civil and administrative enforcement proceedings, such as actions under the False Claims Act and state counterparts (including qui tam actions)
    • State consumer fraud and deceptive practices statutes
    • Deceptive practices and class action cases brought by state Attorneys General's Offices or private plaintiffs
    • Alleged violations of the Stark Law and Anti-Kickback Statute and the Food, Drug and Cosmetic Act
    • Alleged violations of the Foreign Corrupt Practices Act (including qui tam actions)
    • Federal Trade Commission actions
    • Manufacturing practices laws and regulations (e.g., the manufacturing of products regulated by the Food and Drug Administration)
    • Regulations governing federal and state price reporting (e.g., the Medicaid Drug Rebate Program)
    • Marketing, sales and promotional practices, including off-label promotion and physician remuneration and entertainment
    • Research and educational grants
    • Clinical research fraud
    • Continuing medical education

    Representative Matters

    • Acted as lead trial counsel in the largest Medicare and Medicaid healthcare carrier case in the U.S. Recovered damages of $144 million for the Federal Insurance Fund.
    • Obtained dismissal in False Claims Act case against physician arising out of alleged off-label use of spine bone growth product
    • Defended hospital group in a large healthcare fraud case for billing fraud violations. Case involved numerous qui tam matters filed in various district courts and involved the review of millions of documents, hundreds of depositions, numerous court hearings, pretrial motions, etc.
    • Defended and investigated procedures by Department of Justice for billing irregularity issues. Extensive discovery and arguments to grand jury and civil subpoena, deposition, etc. Prevented exclusions and minimized damages to client.
    • Defended numerous hospitals and healthcare providers in government investigations
    • Assisted in the investigation and plea negotiation in one of the largest medical device fraud cases in the state of Virginia
    • Represented physician witness in False Claims Act case in federal court
    • Case involved the challenge by the state of Washington and the Washington State Board of Pharmacy involving the sale of human growth hormones for the treatment of various illnesses.
    • Represented pharmaceutical manufacturer in False Claims Act case in federal court
  • TAX AND TAX-EXEMPT FINANCE

    Our attorneys are well versed in the taxations issues applicable to profit and not-for-profit healthcare organizations. We frequently advise our healthcare clients on matters related to the following:

    • Business entity structures and transactions
    • Formation of not-for-profit and tax-exempt entities
    • Intermediate sanctions compliance
    • Traditional 501(c)(3) private activity bond financings
    • Tax-exempt bond financings
    • Tax-exempt equipment lease/purchase financing transactions
    • Taxation issues related to employee compensation and benefits plans
    • Tax audits, administrative appeals and dispute litigation
    • Local and state compliance and enforcement
    • IRS compliance and enforcement