Explore Our Capabilities

Health Care

Overview

Parker Poe helps a wide range of health care clients in an industry that is heavily regulated and constantly changing. We stay apprised of the latest developments in the law and the business operations of our clients. We understand the market dynamics and legal concerns shaping their business and are able to anticipate and quickly respond to our clients’ legal needs.

Our attorneys have extensive experience in providing legal services to health care clients such as hospitals and health systems, publicly traded health services companies, physician practices, home health, home care and hospice agencies, diagnostic clinics, ambulatory surgical facilities, assisted living facilities, mental health providers, nursing homes, disease treatment centers, clinical laboratories, sleep disorder centers, and trade associations.

BTI Consulting Group ranked our team among national leaders for client relationships in 2017. BTI’s rankings are based solely on in-depth interviews with top legal decision-makers. This feedback put Parker Poe within the top 2 percent of all law firms for client recommendations within the health care industry.

Areas of Focus

Accountable Care Organizations

Accountable Care Organizations (ACO’s) present a new opportunity for health care providers who can demonstrate their ability to deliver high-quality care in a cost-effective manner to Medicare beneficiaries. ACOs are groups of doctors, hospitals, and other health care providers, who agree to act together in a coordinated effort to provide high-quality care to their Medicare patients.  The goal of coordinated care is to ensure that patients, especially those who are chronically ill, receive the appropriate care at the appropriate time, while avoiding unnecessary duplication of services and preventing medical errors.  If successful in these efforts, an ACO should experience cost savings for the intended patient population, and will be able to share in the savings it achieves for the Medicare program.

The collaboration needed to create and operate a successful ACO, and to receive the shared-savings payments from Medicare requires significant investment in infrastructure, careful planning, and consideration of a number of legal issues, including tax, antitrust, Stark, kickback, limitations on gain-sharing, and the regulatory criteria for becoming, and continuing as, an ACO. Our attorneys are experienced in advising clients in all of these related areas of law.


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Anti-Kickback

Parker Poe attorneys have extensive experience advising clients on compliance with the federal anti-kickback statute. The federal anti-kickback statute prohibits, among other things, willfully (a) receiving payment directly or indirectly in return for referring an individual to an entity for the furnishing of an item or service paid for by the a federal health care program (such as Medicare), and (b) paying an entity to induce the entity to refer an individual for the furnishing of an item or service paid for by a federal health care program. The OIG (the federal agency charged with enforcing the statute), has traditionally embraced a broad interpretation of the statute. Therefore, most transactions involving payment between a health care provider and a potential referral source (e.g. other health care providers, medical device companies or other suppliers) can implicate the statute.

Our attorneys frequently assist clients in structuring transactions to comply with the anti-kickback statute, including advice regarding structuring of transactions to fit within the “safe harbors” promulgated by the OIG. Examples include the safe harbor for ambulatory surgery centers, the safe harbor for personal services contracts and management contracts, the “small entity” investment safe harbor, and the safe harbor for space rental arrangements.

The anti-kickback statute is similar to the federal Stark Law in that they both proscribe referrals in certain circumstances in which the referring party receives a financial benefit from the referral. However, the anti-kickback statute is not limited in application to physicians, and also is not limited in application to certain designated types of health care services. Each health care transaction with referring providers should be carefully analyzed and structured for compliance with both the anti-kickback statute and the Stark Law.


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Bankruptcy

Parker Poe’s financial restructuring practice handles all aspects of health care-related insolvencies and restructurings, including the following services:

Purchaser Representation – Parker Poe represents parties in purchasing assets from bankrupt entities. These engagements have included participation in §363 sales, as well as purchases completed in connection with Chapter 11 plan negotiation and confirmation.

Secured Creditor Representation – We routinely represent creditors in Chapter 11 proceedings throughout the United States. Our work regularly includes: protecting cash collateral; negotiating post-petition financings; obtaining adequate protection and relief from stay orders; contesting financing arrangements and plan confirmations; filing involuntary petitions against insolvent debtors; defending preference and fraudulent conveyance actions; and representing governmental taxing authorities in ad valorem tax disputes in bankruptcy.

Debtor Representation – Parker Poe has represented corporations as debtors in Chapter 11 reorganizations and liquidations.

Creditor Committee Representation – Our work includes representation of Committees of Unsecured Creditors.


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Biotechnology, Life Sciences and Pharmaceuticals

Parker Poe provides legal services to entities at the forefront of the pharmaceutical, life science and biotechnology fields. For example, we represent the North Carolina Biotechnology Center (having done so since its inception in 1984) located in the Research Triangle Park. We regularly advise international pharmaceutical and biotechnology companies, government and nonprofit research organizations, contract manufacturers, clinical laboratories, entrepreneurs and scientists.

Experience Highlights

We regularly provide legal assistance in connection with:

  • License and technology transfer agreements
  • Research and development agreements
  • Collaboration, alliance and joint venture agreements
  • Clinical trials agreements
  • Data sharing agreements
  • Marketing, distribution and supply agreements
  • Pharmaceutical and medical device litigation
  • Consulting and independent contractor agreements
  • Bioinformatics agreements
  • Hatch-Waxman Act generic pharmaceutical matters
  • Pharmaceutical patent infringement litigation
  • Trade secret misappropriation litigation
  • Privacy issues
  • Protection of trademarks and other intellectual property
  • Corporate formation and structuring
  • Due diligence, mergers and acquisitions
  • Manufacturing facility development
  • Venture capital fund formation and related transactions

Many of our life sciences and biotechnology clients also work closely with other Parker Poe attorneys who deal with issues such as intellectual property, tax, employment, international business, government relations, antitrust and trade practices, health care, commercial contracts, immigration, environmental, securities and corporate finance. 


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Certificate of Need

Parker Poe attorneys have extensive experience representing clients in all stages of the Certificate of Need (CON) process in the Carolinas. We often become involved in the application, public hearing and public comment process of the CON review. Our attorneys have successfully handled CON appeals, including cases appealed through the court system. We understand that obtaining a CON often is vital to our clients' development plans.

Experience Highlights

Obtaining CON – We have represented clients that have obtained CONs for hospitals, hospital beds, ambulatory surgical facilities, nursing homes, the acquisition of medical equipment such as MRIs, rehabilitation beds, End-Stage Renal Dialysis (ESRD) facilities, diagnostic clinics, hospice agencies and home health agencies. Some of these beds and services have been the result of initial favorable agency decisions or successful settlement negotiations and others have been the result of appeals of initially adverse decisions.

Counseling – As our clients pursue development plans and opportunities, they often need advice and counsel regarding the impact of the CON laws on their short- and long-term plans. We play a key role in advising our clients on these matters and interacting with the CON agency when it is necessary to seek the agency's guidance and/or agreement with our clients' plans. We also have obtained declaratory rulings and other agency determinations that have allowed our clients to proceed with their development plans without the necessity for a CON.


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Clinical Trials

Parker Poe attorneys have assisted facilities, clinical laboratories and physician groups to establish and grow clinical trial programs. Participation in clinical trials can offer a number of professional and economic benefits, but as with any health care venture, there are also a number legal requirements and areas of risk associated with clinical trial programs.

Our services in the clinical trial area include the development of clinical trial agreement templates, development and institution of compliance plans for clinical trial operations, and negotiation of clinical trial agreements with sponsors and trial administrators. We have also assisted clients to develop proposals for the establishment of clinical trials with respect to existing drugs or technologies for a new purpose or for use in a new manner, worked with institutional review boards, prepared authorizations and revised policies and procedures consistent with HIPAA laws governing research activities, and advised clients regarding the confidentiality, patent law and related intellectual property considerations that are part of the clinical trial process.
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Compliance Plans

Health care providers are subject to a broad range of laws and regulations requiring the development of internal policies and plans to ensure training, ongoing compliance and appropriate response to suspected violations. Parker Poe’s attorneys understand the complex requirements of these laws and regulations and work closely with our health care clients to conduct a risk assessment to identify the appropriate scope of compliance plans, to design and implement those plans, to design training for staff, and to develop procedures to monitor for compliance. When suspected violations of the compliance plan are identified, we work with clients to appropriately investigate and address any non-compliant activity.

We also assist clients who are bound by Corporate Integrity Agreements with respect to their ongoing compliance and reporting obligations.
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Diagnostic Imaging and Testing

Parker Poe represents numerous diagnostic imaging and testing facilities and can provide legal advice and representation from start-up through day-to-day operations. Parker Poe provides comprehensive legal advice and representation related to mergers, acquisitions, and joint ventures and assists with Certificate of Need and licensure issues, including Certificate of Need litigation. Legal issues related to diagnostic and imaging testing facilities can vary depending on the ownership structure, but Parker Poe has the knowledge and experience to assist clients with all legal issues related to this industry.
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Educational Institutions

Parker Poe attorneys assist clients in navigating the complex areas where the laws governing health care and education intersect. Our clients include academic medical centers and teaching hospitals, hospital systems that sponsor teaching programs, colleges and universities operating infirmaries and athletic programs maintaining student and faculty health information, health care providers partnering with educational institutions to provide training opportunities, and residential psychiatric facilities providing educational programs to its residents.


Our services on these issues include negotiating residency program sponsorship agreements between health care providers and medical schools; drafting faculty and student handbooks and student athlete policies on the handling of health information under HIPAA, FERPA and other privacy and security laws; negotiating lease agreements for medical facilities on the campuses of colleges and universities; and negotiating agreements between residential psychiatric facilities and local school districts regarding the provision of compliant educational programs. We draw on our vast pool of resources in multiple areas of law to provide clients with understandable and relevant information to solve their legal problems.

For more information regarding Parker Poe’s representation of Educational Institutions, please click here.


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Employee Benefits & Executive Compensation

Our business world is undergoing dramatic change, forcing companies to reset priorities and practices at a time when federal law is shifting standards. As change becomes more of a constant, staying on top of employee benefits law can be overwhelming. 

Parker Poe understands that our clients value up-to-date advice on legislation. We recognize that not every business fits the same mold. Our collaborative approach helps companies tackle cyclical and regulatory needs with flexible and creative solutions.

Our attorneys are experienced in all aspects of the planning, design, implementation, operation and termination of employee benefit plans and executive compensation arrangements. We cover transactional and litigation issues that often arise in connection with benefit programs.

As North Carolina's exclusive representative in the Employment Law Alliance, a national and international network of employment attorneys, we are uniquely positioned to assist employers that have operations and interests in multiple jurisdictions. We provide counsel to a diverse group of publicly traded, private, nonprofit and governmental clients.

Experience Highlights

Retirement Plans – We assist clients with all aspects of design, documentation, operation, reporting and disclosure with respect to tax-qualified and other retirement plans, including:

  • Profit sharing and 401(k) plans
  • Defined benefit and money purchase pension plans, including cash balance plans
  • Leveraged and non-leveraged Employee Stock Ownership Plans (ESOPs)
  • Section 403(b) and Section 457 plans for tax-exempt and governmental employers

Executive Compensation – A significant component of our practice involves executive compensation programs and related ERISA, tax and securities considerations. Our experience includes:

  • Non-qualified deferred compensation plans
  • Excess benefit plans
  • Salary continuation plans
  • Performance-based incentive programs
  • Equity-based arrangements
  • Other supplemental retirement plans
  • Special considerations for deferred compensation of non-profit executives
  • Related financing of such plans through rabbi trusts and other vehicles

Health and Welfare Plans – Our employee benefits attorneys have experience with the design, documentation and operation of:

  • Insured and self-insured group health plans
  • Disability and life insurance plans
  • Cafeteria plans
  • Medical reimbursement plans
  • Transportation plans
  • Flexible benefit plans
  • Severance plans
  • Retiree welfare benefits

We also routinely counsel clients on a variety of welfare plan compliance issues, including COBRA, HIPPA, nondiscrimination testing, Code Section 501(c)(9) VEBA trusts and multiple employer welfare arrangements (MEWAs).

Equity-Based Compensation – We assist clients with all aspects of the implementation of equity-based compensation plans, including design and documentation, stockholder approval and proxy materials and employee communications. We have designed numerous equity compensation programs, including:

  • Incentive and nonstatutory stock options
  • Restricted stock and restricted stock units
  • Stock appreciation rights
  • Phantom stock
  • Employee stock purchase plans
  • Annual and long-term incentive plans

Mergers, Acquisitions and Other Business Transactions – Our employee benefits attorneys are regularly involved in the employee benefits aspects of corporate transactions of all sizes, including:

  • Due diligence and analysis of legal issues
  • Negotiation and drafting of purchase, sale and merger agreements
  • Review of golden parachute implications
  • Post-closing assistance with benefit plan consolidation
  • Negotiation and drafting of benefit liability provisions in financing documents
  • Analysis of deferred compensation arrangements and 409A issues

Administrative Representation and ERISA Litigation – We represent clients before the Internal Revenue Service, the Department of Labor, the Pension Benefit Guaranty Corporation, state departments of insurance and related agencies. Working closely with our employment litigators, we handle a variety of ERISA litigation matters for our clients, such as:

  • Defending claims for denial of medical, disability, life, severance and pension benefits
  • ERISA preemption
  • Subrogation issues
  • Interpleader actions
  • Breach of fiduciary duty claims


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Employment Law

Parker Poe attorneys have extensive experience representing health care clients in all stages of the employment process. We understand that successful management of employees is vital to our clients' success. From drafting employment agreements to enforcing non-competes and from complying with immigration laws to implementing reductions in force, we advise health care clients in their role as employers. Our attorneys regularly handle Equal Employment Opportunity Commission charges, including those that evolve into full-fledged litigation.

Experience Highlights

Counseling – As our clients manage their employees, they often benefit from advice and counsel regarding best practices and the impact of employment laws. We play a key role in advising our clients on these matters and interacting with the state and federal agencies – EEOC, OSHA, NCDOL – that have workplace authority. We can prevent or minimize the impact of many employment issues by: 

  • Reviewing employee handbooks
  • Providing guidance on employment laws
  • Reviewing physician and other health care provider employment agreements
  • Advising on employee termination
  • Providing work force training
  • Conducting internal investigations 

Litigation – Parker Poe has experience representing health care entities in both state and federal court. Our areas of employment experience include Title VII of the Civil Rights Act of 1964, the Age Discrimination in Employment Act, the Americans with Disabilities Act, the Family and Medical Leave Act, the North Carolina Wage & Hour Act, and the Fair Labor Standards Act.


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EMTALA

Parker Poe attorneys have years of experience advising clients on the numerous issues related to the Emergency Medical Treatment and Active Labor Act (EMTALA). Our attorneys have helped general and specialty hospitals and psychiatric facilities develop the policies and procedures necessary for EMTALA compliance. We have advised clients on the legal aspects of the transport and presentation of patients on hospital property, the stabilization and transfer of patients, provider duties to accept patients, including capacity and capability issues, on-call medical staff EMTALA issues, and the liability associated with noncompliance. In addition to assisting our clients with long term compliance program planning, we routinely provide legal advice and counsel to health care providers facing urgent medical situations. Our lawyers provide timely and effective strategies to our clients to enable them to deal with the variety of critical situations where EMTALA obligations are triggered.
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Financing, including bond financing, HUD and private equity

Parker Poe attorneys have considerable experience representing health care clients in financing transactions involving taxable and tax-exempt obligations secured by revenues, mortgages and financing agreements. We have also served as bond counsel and as underwriters counsel in many tax-exempt bond financings, involving bonds issued by governmental units and governmental agencies, including municipalities, hospital authorities and the North Carolina Medical Care Commission. We have represented several hospitals in connection with loans secured by mortgages insured by the U.S. Department of Housing and Urban Development (HUD) through its agent, the Federal Housing Administration (FHA) pursuant to the “HUD-242” program.

For more information regarding Parker Poe’s Banking & Capital Markets practice, please click here.


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Fraud and Abuse

Parker Poe attorneys advise health care clients in the areas commonly referred to as the “fraud and abuse” laws – which includes the federal False Claims Act, the federal anti-kickback statute and the federal self-referral prohibition known as the “Stark Law.” Our attorneys provide the full range of services in the fraud and abuse area, including the areas summarized below.

Compliance Planning
Our attorneys frequently assist clients in analyzing their business practices and drafting corporate compliance plans. Compliance planning accomplishes two goals:

  • first, a good compliance plan identifies compliance risks and trains the workforce to recognize risk areas, thereby reducing the likelihood of expensive and damaging noncompliance with law; and
  • second, a good compliance plan provides proof of good faith effort to comply with law, thereby making possible penalties for noncompliance less likely.

Transactional Advice
Our attorneys assist clients in structuring transactions to comply with the fraud and abuse laws. We also analyze transactions for noncompliance and advise clients on ways to minimize compliance risks. Most transactions can be structured in a manner that will minimize the risk of noncompliance and accomplish the goals of the parties to the transaction.

Investigations
Our attorneys work with health care clients to understand possible compliance issues, build an investigative strategy, conduct a full inspection and provide conclusions and recommended actions. We work quietly on internal matters that never receive public attention, but we also represent clients in all stages of investigations involving grand juries, federal and state courts, regulatory agencies and auditors, congressional inquiries and civil disputes.


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Government Investigations & White Collar Defense

Senior executives and board members are ultimately accountable for the integrity and business activities of a company. Yet, it’s an inside whistleblower or far-reaching government agency that can allege wrongdoing, determine the reputation of an organization and put the performance of individuals and an institution at risk.

This is why – at the first sign of suspected misconduct – companies increasingly perform thorough investigations of possible criminal or non-compliant behavior. How factual and serious are the allegations? What is the depth of the potential problem? How can management control the situation?

Parker Poe conducts independent investigations to find the answers. We work with public and private corporations to understand the foundation of a charge, build an investigative strategy, conduct a full inspection and then provide conclusions and recommended actions. We work quietly on internal matters that never receive public attention, but we also represent clients in all stages of investigations involving grand juries, federal and state courts, regulatory agencies and auditors, congressional inquiries and civil disputes.

We help clients resolve matters quietly and without criminal charges or liability. Meanwhile, we represent companies in furthering the prosecution of individuals and reporting offenses and planned remedies to authorities.

Our Government Investigations & White Collar Defense attorneys have represented executives and corporations in high-profile cases, where their years of courtroom experience were critical to success. The team includes trial lawyers with a background in bet-the-company cases, Department of Justice alumni, former state prosecutors, members of the American College of Trial Lawyers, and veterans of the securities industry.

Because clients conduct business around the world, we’ve participated in global investigations of alleged price-fixing, bribery and kickbacks, and other possible antitrust and FCPA violations and breach of corporate compliance programs. When necessary, we’ve represented these clients before international authorities. Additionally, we have handled multiple export investigations involving EAR, ITAR and OFAC.

We also counsel governments and government officials on investigations of alleged corruption and campaign violations. Among these clients are members of the U.S. Congress and witnesses in state House hearings.


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Government Relations and Lobbying

Our approach to government relations and lobbying combines integrity, personal relationships and experience to produce results for our clients. Our team has earned the trust and confidence of elected officials on both sides of the political aisle, legislative staff members, agency officials and department officials. The members of our lobbying team draw upon many years of experience in government stemming from their backgrounds as legislators, public officials and lobbyists in North Carolina and South Carolina.

Experience Highlights

Our government relations and lobbying practice encompasses activities such as formulating strategy, drafting legislation, appearing before legislative committees and study commissions and intervening directly with legislative officials.

In South Carolina, our government relations capabilities are supported by Parker Poe Consulting LLC,1 a South Carolina limited liability company and wholly-owned subsidiary of Parker Poe Adams & Bernstein LLP. This group of experienced lobbyists provides government relations services in South Carolina to a wide range of businesses and organizations.

1 Although Parker Poe Consulting LLC is a wholly-owned subsidiary of Parker Poe Adams & Bernstein LLP, it is a separate entity, is not a law firm and does not provide legal services. Consequently, Parker Poe Consulting LLC is not subject to the rules of professional conduct applicable to lawyers and law firms, and its clients do not have the benefit of the protections of the attorney-client relationship.


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Health Care Reform Legislation

Health care reform legislation was passed in 2010 in the form of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010. Collectively, these laws will have a profound impact on health care providers and suppliers, employers, health care insurers, state governments and individuals.

Some of the provisions of health care reform legislation were effective immediately or became effective shortly after enactment. Many of the provisions of the health care reform legislation, however, will not take effect for several years. In addition, the full scope of the impact of health care reform will not be fully known until the issuance of the implementing regulations.  

The law is broad in scope. Health care reform legislation includes incentives offered to employers to provide health insurance to their employees, expansion of the eligibility requirements for Medicaid coverage, high-risk pools to allow individuals with pre-existing conditions to acquire health insurance (and, ultimately, a provision prohibiting health care insurers from excluding individuals with pre-existing conditions from coverage), funds for demonstration projects and incentives for medical research aimed at increasing the efficiency of the delivery of health care services, provisions intended to curb fraud, waste and abuse in the health care system, and a number of tax provisions intended to generate revenue to cover the governmental costs of health care reform.

Attorneys from a number of practice areas at Parker Poe are focused on health care reform legislation and its impact on our clients interests. We keep up to date with regulations related to health reform as they are issued and work closely with clients to address the current and future requirements of health care reform legislation.


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HIPAA

Parker Poe attorneys provide counseling and other legal services in matters involving privacy, security, benefits and electronic data exchange from the viewpoints of health plans, health care providers and related businesses.

The Health Insurance Portability and Accountability Act (HIPAA) includes numerous provisions affecting health plans, health providers, insurers and businesses in the health care field. Attorneys from our employee benefits, health care, employment and corporate practice areas are well-versed in these areas and assist clients in meeting the demands of privacy, security, benefits and electronic data exchange.

Experience Highlights

We are actively involved in working with clients and speaking and writing on topics such as:

  • Compliance with HIPAAs privacy requirements as they affect health care information, including preparing employee and patient notices, plan policies and procedures, plan amendments and authorization and other forms

  • Consultation with clients regarding privacy training for workers

  • HIPAAs portability and accessibility rules impacting health plans

  • Review and preparation of business associate contracts and related review of third-party administrator contracts

  • HIPAAs interface with workers compensation, Family and Medical Leave Act (FMLA), Americans with Disabilities Act (ADA) and other state and federal laws

  • Compliance with electronic data interchange (EDI) rules, transactions and code sets standards and other data and security requirements

  • Gramm-Leach-Bliley and other privacy/security legislation

  • Advising clients on HIPAA compliance requirements for business associates


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HITECH

In February of 2009, Congress enacted the American Recovery and Reinvestment Act of 2009 (“ARRA”) to stimulate the United States economy. Included in ARRA are provisions to allocate approximately $19 billion for the adoption and implementation of health information technology in the health care industry, including electronic health records (EHRs) and e-prescribing. These provisions are known as the Health Information Technology for Economic and Clinical Health Act, or the “HITECH ACT”. Physicians and hospitals will be able to apply for incentive payments to be used for purchase and implementation of health information technology if they can demonstrate “meaningful use” of “certified” EHR technology. “Meaningful use” will require the external exchange of health information to improve quality of care (including implementation of community-wide Health Information Exchange Networks (HIEs) and Regional Health Information Organizations (RHIOs)), and e-prescribing.

Parker Poe health care attorneys assist hospitals and physicians in understanding the implications and opportunities of the HITECH Act and the adoption and implementation of electronic health records and health information exchange. Our attorneys can assist with preparations to qualify for the available incentive payments, and can assist with health information technology strategies and plans and evaluation of and contracting with vendors for health information systems. Parker Poe attorneys also assist health care clients in complying with other HITECH provisions which modify HIPAA privacy and security requirements for covered entities and business associates.
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Hospital Governance


Parker Poe attorneys are knowledgeable regarding hospital governance matters, including Sarbanes-Oxley issues, conflict of interest rules and board procedural requirements. Much of our experience has involved dealing with issues specific to governmental (public) hospitals, such as open meetings laws, public record acts and specific conflict of interest statutes. We are also familiar with the requirements of the business corporation and nonprofit corporation laws relating to the duties and liabilities of governing board members and the available protections from liability, including legal defenses, immunities, insurance coverage and indemnification rules.


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Information Technology and Electronic Medical Records

Parker Poe has broad experience in representing hospitals, physician clinics and other health care providers in the negotiation of licenses and maintenance agreements for electronic medical record and other software, software as a service agreements, and agreements for the acquisition, installation and configuration of digital imaging equipment and other systems. Our attorneys also advise health care clients on privacy and security requirements in the technology context. Our firm’s deep experience in both health care and information technology allows us to provide efficient and effective advice on technology projects.

For more information regarding Parker Poe’s Information Technology practice, please click here.


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Insurance Coverage


Parker Poe represents both policyholders and insurance companies on insurance coverage issues by providing advice on whether certain claims are covered by certain policies and, when necessary, by litigating coverage disputes. These issues continue to grow in complexity as new theories of liability give rise to disputes over insurance coverage for such claims.

We have experience with many types of coverage issues, including those concerning environmental damage, employment practices, construction defects, business interruption, directors and officers liability, contractual and commercial disputes and products liability.


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Internal Investigations

Health care entities are often faced with the problem of suspected misconduct. Parker Poe conducts internal investigations to find the answers. We work with health care entities on internal investigations to understand the concerns, build an investigative strategy, conduct a full inspection and then provide conclusions. We recommend and help to implement corrective actions, ranging from updating policies and procedures to self-disclosures to the Department of Health and Human Services, Office of Inspector General.

In the employment context, Parker Poe has vast experience investigating alleged violations of workplace laws, including Wage and Hour, Occupational Health and Safety, and anti-discrimination statutes. Our attorneys have litigation experience in each of these areas and also understand the importance of resolving employment issues internally or at the agency level. Our team can conduct employment audits for compliance with all applicable laws, including Form I-9 requirements.


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Licensure, Certification & Reimbursement Issues

We regularly assist our health care clients with the vast array of regulations and agency policies and practices in licensure, certification and Medicare and Medicaid and private payor reimbursement issues.

Experience Highlights

Licensure & Certification – We advise clients on licensure and certification surveys, compliance investigations and penalty assessments and represent them in challenging adverse determinations. We frequently communicate on behalf of our clients with state licensure and certification agencies, fiscal intermediaries and the Centers for Medicare and Medicaid Services.

Reimbursement – We help our clients understand the reimbursement rules, represent them when the federal or state government seeks to recoup monies paid and deal with payment disputes between our clients and government and private payors.

Featured Experience

  • Represented a hospital client in an administrative appeal which resulted in the reversal of a decision by the state Medicaid agency to recoup hundreds of thousands of dollars
  • Enjoined state Medicaid agency from imposing a rate reduction upon home care providers and convinced the agency through an administrative appeal to abandon the rate reduction
  • Obtained decisions from an administrative law judge and a superior court judge preventing the states Medicaid agency from imposing Medicaid program changes on the grounds that these changes violated state and federal law
  • Settled numerous recoupment proceedings against our clients for substantially less than the agency initially sought to recover

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Medical Records

Parker Poe attorneys regularly advise physician groups, hospital systems and other health care providers on the rules and regulations concerning medical records. We counsel clients on general issues specific to medical records ranging from third-party access and transfer of records to appropriate storage and disposal. We also advise clients regarding preservation and production of medical records during investigations and litigation, patient information appropriate for inclusion in (and exclusion from) medical records, and disciplinary actions for employees/staff members who fail to complete medical records in a timely manner. In addition, we have assisted clients with concerns regarding electronic medical records, personal health records, permissible disclosures under federal and state laws and responses to patient requests for amendment under HIPAA.

 

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Mergers, Acquisitions and Joint Ventures

Parker Poe attorneys regularly advise physician groups, hospital systems and other health care providers concerning mergers, acquisitions, joint ventures and other business combinations. Our experience with the health care industry and its regulatory environment allows us to guide business combinations successfully within the limits set by federal and state governments.

We routinely handle mergers and acquisitions of hospital systems and physician groups and between hospital systems and physician groups, joint ventures among providers, and real estate acquisitions. In addition, we advise clients on the operational and regulatory issues unique to business combinations in the health care industry, including compliance with federal and state anti-kickback laws, Stark and HIPAA and the process for changes of ownership (CHOWs) with federal and state agencies.

For more information regarding Parker Poe’s Mergers, Acquisitions and Joint Venture practice, please click here.
 


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Peer Review and Medical Staff Privileges

Parker Poe attorneys are experienced in counseling a wide array of health care providers on issues relating to medical staff privileges and peer review activities. Our attorneys routinely assist hospitals and other providers in drafting medical staff bylaws, creating and implementing credentialing and peer review policies and procedures, and providing ongoing guidance to these providers on all of the issues associated with effective and efficient administration and risk management. Our attorneys work closely with health care providers in navigating the hearing and review process to ensure compliance with the relevant state and Federal laws. Our services in this area commonly include analyzing existing contracts, developing management structures, representing physicians and hospitals before state licensing boards, and conducting legal audits of financial relationships between physicians and providers.

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Privacy and Security


Parker Poe attorneys routinely counsel clients on compliance with federal and state laws regarding health information privacy and security and are frequent speakers on privacy and security topics. We advise clients on a daily basis on real-life questions concerning compliance with HIPAA, the Red Flag Rules and other federal and state laws governing the privacy and security of information. In addition, we strive to keep our clients updated on the frequent changes in the regulatory environment.

Our services in the privacy and security area include assistance with: HIPAA implementation and on-going compliance; preparation and implementation of Red Flag Rules policies; compliance with the NC Identity Theft Act and other similar state laws; responses to security breaches; conducting privacy and security risk assessments; review of privacy and security policies in light of new requirements under the American Recovery and Reinvestment Act of 2009; responses to government audits and investigations of privacy and security breaches; and conducting educational and training seminars on privacy and security issues.

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Products Liability


Parker Poe provides products liability advice and litigation services in matters involving manufactured products, including pharmaceuticals and medical devices.
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Professional Licensing


Parker Poe attorneys represent health professionals involved in preparing and submitting licensing applications as well as in administrative investigations and disciplinary proceedings initiated by state licensure authorities. We guide clients from the receipt of an initial complaint through the investigation process, and defend our clients against formal disciplinary charges in contested hearings. We also provide counsel on the laws and policies governing licensure of health professionals to assist them with various issues, including compliance, corporate structure, and employment.

Our services have included assisting physicians, dentists and other professionals responding to inquiries made during licensing board investigations; accompanying clients to meetings with investigators and licensing board staff; obtaining an injunction against a licensing board for the improper release of a professional’s psychiatric records; filing pleadings and representing clients through formal disciplinary hearings; and negotiating public and private settlements of formal disciplinary charges. We also have advised pharmacies regarding various reporting requirements imposed by licensing board and have advised health care clients regarding limitations on corporate structure and employment of health professionals imposed by licensing boards.

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Professional Negligence Defense


Our clients call on us for representation in professional negligence claims in state and federal courts in North Carolina and South Carolina. Because a professional's reputation is his or her most valuable asset, Parker Poe is at the forefront in finding creative ways to avoid litigation and publicity where possible through alternatives such as arbitration and mediation. These alternatives often result in early resolution and significant cost savings. We also understand that an allegation of professional negligence requires a vigorous defense, and our experience and knowledge enables us to defend professionals aggressively.


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Real Estate


The Real Estate and Commercial Development attorneys at Parker Poe understand and appreciate the unique issues confronting the medical profession in connection with its real estate needs. Our work in connection with space leases, ground leases, sales and purchase contracts, and development and loan transactions is creatively tailored to address the concerns of every type of health care provider, including but not limited to issues associated with environmental matters, bio-hazardous waste disposal and LEED certification. Our real estate practitioners assist individual physicians, medical groups, clinics, hospitals and palliative care and hospice providers in connection with all of their real estate transactions. The hallmark of our approach is simple: we treat the real estate issues of our medical clients as if they were our own.

For more information regarding Parker Poe’s Real Estate practice, please click here.
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Reimbursement, Including Medicare, Medicaid and Commercial Third-Party Payers

Parker Poe has extensive experience helping health care providers negotiate complex reimbursement issues with all types of payers, including Medicare, Medicaid and commercial payers.

Parker Poe advises clients and negotiates resolution of reimbursement disputes. Parker Poe has assisted clients with administrative challenges to Medicare RAC audits, Medicaid Post-Payment Reviews, and other Medicare and Medicaid overpayment determinations.

Our team of health care attorneys provides comprehensive legal advice on all local, state and federal laws, rules and coverage determinations related to reimbursement from governmental payers. We also have extensive experience negotiating managed care contracts and other participating provider agreements with commercial third-party payers, as well as advising IPAs and other provider networks regarding third-party payer contracting.

Parker Poe attorneys bring a wealth of experience and provide complete legal support with regard to all facets of third-party payer relations.


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Risk Management


Parker Poe attorneys are experienced in the identification and analysis of risk events and utilize a multi-disciplinary approach to risk management for our health care clients. A single event may require consideration of multiple impacted areas, such as patient care, mandatory event reporting obligations, governmental billing requirements, physician staff privileges or licensure, relationships with employees and other staff members, potential exposure to litigation, and the cost of potential risk-elimination or risk-mitigation solutions.  Our attorneys are experienced and skilled in assisting our clients to identify and analyze the appropriate considerations and develop solutions to risk events.

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Stark/Self-Referral

Parker Poe attorneys have extensive experience advising clients on compliance with the federal law prohibiting physician self-referrals, known as the Stark Law. The Stark Law generally prohibits referrals by physicians for certain “designated health services” to entities with which they have a financial relationship. The Stark Law is complex, includes a large number of exceptions, and is further explained and interpreted by several hundred pages of regulations.

Our attorneys frequently assist clients in structuring transactions to comply with the Stark Law, including advice regarding structuring of transactions to fit within the Stark Law exceptions, such as the “in-office ancillary services” exception, the exception for personal services agreements, and the exception for leasing arrangements. For example:

  • large medical practices must consider the Stark Law in drafting their compensation plans for physicians, since the “in-office ancillary services” exception has specific limitations applicable to physician compensation plans
  • hospital recruitment agreements with physicians should be carefully reviewed for compliance with Stark Law requirements, particularly if they are three-way agreements between the hospital, a medical practice, and the recruit
  • management agreements and services agreements between physicians and hospitals or other health care providers must be structured to comply with Stark Law exceptions, since even inadvertent violations of the Stark Law can result in substantial compliance risk


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Tax-Exempt Hospitals and Health Systems

Tax-exempt health care entities frequently call on Parker Poe attorneys for advice on issues involving federal, state and local taxes, including income, excise, sales and property taxes. We routinely assist in the preparation of tax exemption applications (Form 1023) for newly organized entities, advise tax-exempt organizations on the new federal reporting requirements (Form 990) and help tax-exempt hospitals with local property tax-exemption matters.

Parker Poe helped a tax-exempt hospital obtain a letter ruling that it is not required to file the Form 990. Additionally, we advised a nonprofit, tax-exempt hospital on the federal tax issues involved in its proposed merger with a hospital owned by a county-owned hospital operated by a hospital authority.

For more information regarding Parker Poe’s Tax practice, please click here.


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Venture Capital & Emerging Companies


Parker Poe provides strategic legal counsel to emerging growth companies – including Internet, new media, electronic commerce, networking, information technology, biotechnology, telecommunications and health care companies – as well as technology incubators, investment banks and venture capital firms that service such companies. We counsel client in a full spectrum of sophisticated matters, including financing, mergers and acquisitions, licensing agreements, strategic partnering and technology transfer transactions.

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Representative Experience

Certificate of Need

  • Served as general counsel to a state association of health care providers with more than 600 members.
  • Obtained favorable decisions in contested CON cases before the South Carolina Department of Health and Environmental Control and the North Carolina Division of Facility Services.
  • Obtained favorable decisions from the North Carolina Court of Appeals and Supreme Court regarding the scope of certain development activities permissible under North Carolina's Certificate of Need law.
  • Counseled and guided clients through the application process for CONs, enabling them to expand their health care facilities, build new hospitals, and acquire state-of-the-art technology. Successfully represented clients in CON-related administrative appeals.

Employment Law

  • Successfully resolved religious discrimination lawsuit brought by Equal Employment Opportunity Commission against a hospice home care agency.
  • Successfully resolved sexual harassment allegations brought against a doctor by a physician’s assistant. 
  • Defeated at the agency level age discrimination charges brought by a certified nursing assistant against a hospital.
  • Successfully resolved disability discrimination case brought by a nurse against a physicians practice.
  • Defeated in federal court the discrimination claims of a salesperson previously employed by a national provider of laboratory services.

Financing

  • Represented the borrowing hospitals in connection with three separate FHA insured mortgage revenue bond transactions involving tax-exempt bonds in the total amount of $204 million.

Hospital Governance

  • Prepared and delivered a presentation on the Sarbanes-Oxley Act to a hospital governing board.

Information Technology and Electronic Medical Records

  • Represented the winning bidder in the state's largest information technology procurement involving a $171 million contract to replace and operate the state's Medicaid claims processing system and service the technology needs of several other state agencies.

Mergers, Acquisitions and Joint Ventures

  • Represented buyer of health services businesses in series of strategic "rollup" acquisitions.
  • Represented hospital system in series of physician practice acquisitions and related development of integrated health care system.
  • Represented constituents in physician practice merger transactions.
  • Represented both hospitals and physicians in various ambulatory surgery and other health services joint ventures.
  • Represented a nonprofit hospital system in connection with a "virtual" merger with a hospital authority, pursuant a joint operating agreement.

Reimbursement

  • Enjoined program changes announced by the states Medicaid agency that would have seriously affected industry providers.

Tax-Exempt Hospitals and Health Systems

  • Obtained a letter ruling for a public, nonprofit hospital that it is not subject to the Form 990 filing requirements.

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