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Parker Poe

Explore Our Capabilities

Health Care

Overview

Parker Poe has spent decades cultivating trusting relationships with a wide range of health care clients. We have one of the largest health care teams of any Southeastern firm with respect to the number of lawyers who work exclusively for providers. Our lawyers are also part of a broader Health Care Industry Team that takes a big-picture approach to the challenges and opportunities hospitals and other providers face. With this combination of deep health care industry knowledge, broad experience across many areas of law, and the support of a 275-attorney firm stretching from Washington, DC, to Atlanta, we are uniquely positioned to help clients solve problems and, more importantly, avoid them.

Our lawyers have extensive experience in providing legal services to 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. We are committed to partnering with each and every client, investing the time to learn your business so we can most effectively advise and advocate for you.

Areas of Focus

Anti-Kickback

We have extensive experience structuring transactions to comply with the federal Anti-Kickback Statute and responding to government investigations involving that statute. Our team includes attorneys with significant in-house experience at health systems, so we understand both the legal nuances and the practical implications of the statute.

We have advised on anti-kickback compliance in hundreds of transactions running the gamut in the health care industry, including value-based arrangements. We know the key sticking points to avoid and safe harbors to use in drafting agreements, structuring deals, and performing due diligence for potential mergers or acquisitions.

Our team also knows how to respond when the Office of Inspector General (OIG), the Centers for Medicare and Medicaid Services (CMS), or other regulators begin an investigation tied to the statute. We have represented a variety of health care clients in these types of responses.

Our counsel in transactions and investigations also incorporates our deep knowledge of the Physician Self-Referral Law, often called Stark Law. Stark Law and the Anti-Kickback Statute are frequently implicated in the same transactions and investigations. You can find more on Stark Law near the bottom of our Areas of Focus.


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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 Section 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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Behavioral Health

We advise a wide range of behavioral health providers, including community-based mental health providers, residential behavioral health providers, and psychiatric hospitals. We represent them in professional licensure services and disputes, Certificate of Need (CON) applications and appeals, HIPAA and other privacy questions, and repayment requests and other payment issues, including those involving Medicaid and private insurance. 

We have a thorough grasp of not only the business and regulatory aspects of behavioral health but also the unique clinical situations that can give rise to regulatory issues. For example, we understand how a patient’s diagnosis can impact a regulatory dispute. 

Behavioral health industry groups have turned to our team for direct representation, for help crafting regulatory and legislative changes important to behavioral health providers, and for speaking engagements analyzing the latest trends.


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Certificate of Need

We have extensive experience representing clients in all stages of the Certificate of Need (CON) process in the Carolinas, as well as helping clients navigate CON reform in those states.

In states that maintain CON, we often become involved in the application, public hearing, and public comment process of the CON review. Our attorneys have successfully handled CON contested cases in administrative law courts and appeals to higher courts. We understand that obtaining a CON often is vital to our clients' development plans.

We have represented clients that have obtained CONs for hospitals, hospital beds, ambulatory surgical facilities, nursing homes, cardiac catheterization labs, the acquisition of medical equipment such as MRIs, rehabilitation beds, end-stage renal disease (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. We have also represented our clients in opposing the approval of a CON because of a lack of need or an adverse impact on operations.


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Clinical Trials

Parker Poe attorneys have assisted facilities, clinical laboratories, contract research organizations, and physician groups in establishing and growing 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 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, service agreements and statements of work with sponsors, investigators, site management organizations, integrated research organizations, and trial administrators. We have also assisted clients in developing 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.  We have advised clients regarding the confidentiality, patent law, and related intellectual property considerations that are part of the clinical trial process as well.


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Diagnostic Imaging & 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 their 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.


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Employee Benefits & Executive Compensation

We have decades of experience counseling dozens of hospitals, health systems, and other health care clients on employee benefits, including assisting with all regulations related to benefit plans. We have assisted clients in the health care industry in designing and drafting retirement plans that include 401(a), 403(b), 457(b) and (f), and frozen pension plans, and also cafeteria plans, wrap plans, and other health and welfare plans.

We also provide regular assistance in connection with the day-to-day administration of these plans. Our day-to-day support has included assisting hospital boards and other fiduciaries with the documentation, review, and negotiation of services agreements and with the adoption of best practices with respect to applicable fiduciary duties.

Additionally, we have extensive experience helping hospitals with all types of compensatory arrangements, including representing hospitals in negotiations with doctors and structuring their employment and compensation agreements. Other stakeholders or service providers may play an important role in these work streams, such as compensation consultants. We generally work in close collaboration with these stakeholders and service providers and ensure that the governing documents reflect the intended design and otherwise comply with applicable laws, all while achieving tax efficiency.

We regularly advise both governmental not-for-profit and private not-for-profit hospital systems and health care providers on compensation and benefits arrangements and are intimately familiar with the different sets of rules that apply to each. We have helped many not-for-profit hospital boards structure compensation packages that meet their goals, navigate the Internal Revenue Service’s prohibition on “excess compensation,” and avoid intermediate sanctions. We have strong working relationships with hospital board members, attend board meetings when useful, and take pride in being accessible when questions arise. In this capacity, again, we routinely work in collaboration with separate tax advisers, and in such a case, our role is to focus primarily on the governing legal documents, as indicated above.


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Employment Law

We have extensive experience representing health care clients in all stages of the employment relationship. We understand that successful management of employees is vital to our clients' success. From drafting employment agreements to enforcing noncompetes 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 employment claims before administrative agencies, including the Equal Employment Opportunity Commission and Department of Labor, as well as claims that evolve into full-fledged litigation.

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 issues and interacting with the state and federal agencies – including EEOC, OSHA, NCDOL, and USDOL – that have workplace authority. We can prevent or minimize the impact of many employment issues by:

  • Reviewing employee handbooks
  • Providing guidance on employment laws, such as compliance with the ADA and FMLA
  • Reviewing physician and other health care provider employment agreements
  • Advising on employee discipline and 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 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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False Claims Act Investigations & Whistleblower Defense

From the moment the government or a whistleblower (qui tam plaintiff) first raises a claim, health care providers rely on our team to defend their interests and navigate the high-stakes process that follows. We have defended clients against claims involving the Anti-Kickback Statute, Stark Law, and upcoding allegations. We have a proven track record of success helping clients prevent state and federal False Claims Act violations to begin with, as well as avoiding prosecution and negotiating reduced fines and penalties when such violations do arise.

Examples of our experience include:

  • Represented numerous health care providers in False Claims Act investigations by the Medicaid Investigations Unit of the North Carolina Attorney General's Office.
  • Represented health care provider in a False Claims Act case filed by a former employee alleging more than $90 million in damages based on alleged false claims submitted to Medicare, Medicaid and TRICARE. Parker Poe’s internal investigation was able to disprove the relator’s allegations, the case was dismissed, and the investigation closed after Parker Poe presented the findings of its internal investigation to the Department of Justice and the U.S. Attorney’s Office for the Eastern District of North Carolina.

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Financing Through Bonds, HUD & Private Equity

We have considerable experience representing health care clients in financing transactions involving taxable and tax-exempt obligations. We frequently represent borrowers in the health care industry in asset-based financings secured by accounts receivable, fixed assets, inventory, and real property. In addition, our public finance team is nationally recognized for its skill. We regularly serve as bond counsel in 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 also represented 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.

In addition, we have private equity attorneys with particular experience in health care products and services. We advise on the structuring, negotiation, and documentation of a full range of private equity transactions. 


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Government Relations

We have a proven track record helping health care clients successfully navigate the halls of government at the federal, state, and local level. Our team understands how government operates and works with each of our clients to develop a lobbying strategy with a clear objective and outcome.

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. Our approach to government relations and lobbying combines integrity, personal relationships, and experience to produce results for our clients. We have earned the trust and confidence of elected officials on both sides of the political aisle, as well as 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 public officials and lobbyists.

In South Carolina, our government relations capabilities are supported by Parker Poe Consulting LLC, a wholly owned subsidiary of Parker Poe Adams & Bernstein LLP. 


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HIPAA, HITECH & Data Privacy

We provide counseling and other legal services involving privacy, security, benefits, electronic data interchange (EDI), and health information technology from the viewpoints of health plans, health care providers, and related businesses.

The Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) include 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 teams are well-versed in these areas and assist clients in meeting the demands of privacy, security, benefits, EDI, and health information technology.

Our team is experienced with analyzing health information technology opportunities, including electronic health records, e-prescribing, health information exchange networks, and regional health information organizations. We assist clients with evaluating and contracting with vendors for health information systems. Our attorneys also assist health care clients in complying with other HITECH provisions that modify HIPAA privacy and security requirements for covered entities and business associates.

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

  • Compliance with HIPAA's privacy requirements as they affect health care information for providers and health plans, including preparing employee and patient notices, plan and provider policies and procedures, plan amendments, and HIPAA authorization and other forms.
  • Review and preparation of business associate contracts, including analysis of when a business associate agreement is required under HIPAA.
  • HIPAA compliance requirements for business associates and subcontractors.
  • Consultation with clients regarding privacy training for workers.
  • Responses to data security breaches, including notifying affected parties and navigating government audits and investigations.
  • HIPAA's portability and accessibility rules impacting health plans.
  • Review of third-party administrator contracts.
  • Compliance with EDI rules, transactions and code sets, standards, and other data and security requirements.
  • HIPAA's interface with workers' compensation, the Family and Medical Leave Act (FMLA), the Americans with Disabilities Act (ADA), and other state and federal laws.
  • Compliance with the Gramm-Leach-Bliley Act, Red Flag Rules, and evolving federal and state privacy/security legislation and regulations.

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Home Care & Hospice

We advise home health and hospice providers on state and national policies and regulations, including communicating with federal agencies. We have also handled class actions against long-term care providers, including successfully defending a home care provider in a large, multistate class action. In addition, we represent home health and hospice providers in licensure services and disputes, audits, Certificate of Need (CON) applications and appeals, and other legal needs.


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Information Technology & 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 records (EMRs) and other software, software-as-a-service (SaaS) 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.

In addition to our guidance on EMR agreements, we 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, safeguarding, 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.

We have also 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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Insurance Coverage

In the health care industry, we represent insureds regarding professional liability, government investigations, and other areas covered by certain insurance products. Our attorneys represent patients in connection with health insurance denials and terminations as well.

We provide advice on whether certain claims are covered by certain policies and, when necessary, we litigate coverage disputes. We have experience with many types of coverage issues, including those concerning environmental damage, employment practices, construction defects, business interruption, directors and officers (D&O) liability, contractual and commercial disputes, and products liability.


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Internal & Government Investigations

When our health care clients suspect misconduct within their own workforce, our team works to understand the concerns, fully identify the scope of potential misconduct, 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 employment team can conduct employment audits for compliance with all applicable laws, including Form I-9 requirements.

We have also worked with health care clients facing prosecution or government investigations. We have a deep bench of trial lawyers with a background in bet-the-company cases, including Department of Justice alumni, former state prosecutors, and members of the American College of Trial Lawyers.

In addition, we counsel clients on avoiding scrutiny from regulators or law enforcement in the first place by designing and implementing compliance and detection policies to identify risks and avoid them.


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Licensure & Certification

We regularly assist our health care clients with the vast array of regulations and agency policies concerning licensure and certification. We advise clients on licensure and certification surveys, compliance investigations, and penalty assessments. We represent them in contesting and appealing 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. 


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Life Sciences, Biotechnology & Pharmaceuticals

We provide legal services at the forefront of the life sciences industry. Our clients include some of the top pharmaceutical, biotechnology, and medical device companies in the world. We also regularly advise clinical laboratories, government and nonprofit research organizations, entrepreneurs, and scientists. We have been helping build a robust infrastructure for life sciences companies for more than 35 years, including through our representation of the North Carolina Biotechnology Center since its inception. Today, we partner with state and local economic development alliances and industry groups that support the life sciences from Atlanta to Washington, DC. 


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Medical Malpractice Defense

Parker Poe's medical malpractice attorneys have decades of experience defending health care providers in federal and state courts. Our team features veteran trial attorneys who have taken dozens of cases to jury verdicts, many with multimillion-dollar claims for damages. We also have deep experience representing health care professionals facing patient complaints or other disciplinary action before state licensing boards and other regulatory agencies. Our clients include hospitals, physicians, physician extenders, nurses, other health care providers, medical device manufacturers, and their insurers.

National and state organizations have recognized our medical malpractice attorneys as leaders in their fields. Our team includes attorneys who have served in leadership positions with the Defense Research Institute and the North Carolina Association of Defense Attorneys. The Litigation Counsel of America, Benchmark Litigation, and The Best Lawyers in America have also recognized the skill of these trial lawyers.


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Mergers, Acquisitions & 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 Law, and HIPAA, as well as the process for changes of ownership (CHOWs) with federal and state agencies.

We have also advised hospital systems on the employee benefits aspects of mergers and acquisitions, including integrating compensation packages and benefits plans following acquisitions. Our overall depth of knowledge with hospital benefits and compensation allows us to help our clients quickly understand their options in a merger or acquisition and move forward with an integration strategy. We also consider ourselves partners with hospitals’ in-house teams, executives, and HR professionals in helping with the transition for newly acquired employees.


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Patient Care & Consent

Our team helps hospitals and providers navigate the legal and ethical nuances of patient care decisions, including those involving consent, competence, guardianship, involuntary commitment, advance directives, and end-of-life care.

We have a thorough understanding of consent and competency laws across the United States, and we appreciate the uniquely challenging ways those laws intersect for health care providers. Our team has decades of trial experience representing hospitals in psychiatric involuntary commitment proceedings. We frequently help health care facilities evaluate and complete the guardianship process when there is no one available or willing to act on behalf of an incapacitated patient.

Our deep experience with patient care and consent laws across a range of health care settings helps us understand not just what the laws say but also their context and how to apply them in time-sensitive situations. We have drafted and revised internal policies and procedures to ensure compliance with the law as it evolves, and we offer training sessions remotely or in person for medical staff leadership, clinicians, and hospital staff on the practical application of the law. No two cases are alike, and Parker Poe brings its wide-ranging experience in patient care matters to bear every day as we help our clients respond in ways that meet their goals and move forward their missions.


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Peer Review & 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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Product Liability

We provide product liability advice and litigation services in matters involving manufactured products, including pharmaceuticals and medical devices. We represent clients before regulatory agencies and industry groups and have provided guidance in responding to inquiries and audits by federal regulatory agencies. We have traveled the country on behalf of clients, dealing with particularly worrisome products or efforts to resolve claims prior to formal litigation.


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Professional Licensing

We 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 we 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, pharmacists, nurses, and other professionals in responding to inquiries made during licensing board investigations.
  • Accompanying clients to meetings with investigators and licensing board staff.
  • Filing pleadings and representing clients through formal disciplinary hearings.
  • Negotiating public and private settlements of formal disciplinary charges.
  • Advising clients on various reporting requirements, limitations on corporate structure, and issues related to the employment of health professionals.
  • Advocating for policy changes.
  • Seeking guidance on, and changes to, scope of practice and other professional licensing matters.

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Real Estate

We 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, options, and development and loan transactions is creatively tailored to address the concerns of every type of health care provider.

Our experience includes advising on issues associated with site evaluations, environmental concerns, biohazardous 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.


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Reimbursement Negotiations & Disputes

We have extensive experience helping health care providers negotiate complex reimbursement issues with all types of payers, including Medicare, Medicaid, and commercial payers. 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 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 independent physician associations (IPAs) and other provider networks regarding third-party payer contracting.

We bring a wealth of experience and provide complete legal support with regard to all facets of third-party payer relations. Examples of our work in this area include:

  • Represented a hospital client in an administrative appeal that 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 state's 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.
  • Represented clients at the state and federal level, successfully challenging adverse Medicare and licensure certification survey findings resulting in significantly reduced civil monetary penalties.
  • Assisted clients in the licensure of all types of health care facilities and services and enrollment in state and federal provider reimbursement programs.
  • Negotiated settlement of potential Medicare fraud charges to allow provider to maintain Medicare enrollment.

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Risk Management, Compliance & Governance

Our Health Care Team works with clients to manage their risks on an ongoing basis by helping to build and implement processes to proactively identify and, once identified, prevent or ameliorate events that may result in business interruption, litigation, regulatory noncompliance (including criminal exposure), or disruption of contract/vendor relationships.

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 responses to suspected violations. Parker Poe's attorneys understand the complex requirements of these laws and regulations. We work closely with our health care clients to conduct a risk assessment to identify the appropriate scope of compliance plans, design and implement those plans, design training for staff, and develop procedures to monitor for compliance.

When a risk becomes a reality, our team works with the client to identify all of the potentially impacted areas, such as patient care, public opinion, mandatory event reporting obligations, governmental billing requirements, physician staff privileges or licensure, retention, relationships with employees and other staff members, potential exposure to litigation, and the cost of potential risk-elimination or risk-mitigation solutions. We then develop an action plan with the client to eliminate the risk going forward to the greatest extent possible.

In addition, we advise clients on hospital governance, 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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Stark/Self-Referral

Parker Poe attorneys have extensive experience structuring transactions to comply with the Physician Self-Referral Law, often called Stark Law, and responding to government investigations concerning that law. Our team includes attorneys with significant in-house experience at health systems, so we understand both the legal nuances and the practical implications of Stark Law.

We have advised on Stark Law compliance in thousands of transactions and contracts, including value-based arrangements, physician compensation plans, personal services agreements, employment agreements, recruiting agreements, management agreements, and leasing arrangements. We frequently structure those agreements and others to fit within safe harbors or exceptions, and we understand the interplay between those requirements and “incident-to” billing and supervision requirements.

Our team also knows how to respond when the Office of Inspector General (OIG), the Centers for Medicare and Medicaid Services (CMS), or other regulators begin an investigation tied to physician self-referrals. We have represented a variety of health care clients in these types of responses.

Our counsel in transactions and investigations incorporates our deep knowledge of the Anti-Kickback Statute as well. Stark Law and the Anti-Kickback Statute are frequently implicated in the same transactions and investigations. You can find more on the Anti-Kickback Statute near the top of our Areas of Focus.


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Tax-Exempt Hospitals & 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 federal reporting requirements (Form 990), and help tax-exempt hospitals with local property tax-exemption issues. We also routinely assist tax-exempt hospitals and other organizations with bond financing, including compliance with bond covenants, compliance with fundraising and lobbying requirements, and with executive compensation and employee benefits. 

Examples of our work include helping a tax-exempt hospital obtain a letter ruling that it is not required to file the Form 990 and advising a nonprofit, tax-exempt hospital on the federal tax issues involved in its proposed merger with a county-owned hospital operated by a hospital authority. We routinely advise nonprofit, tax-exempt hospitals on the federal tax issues implicated by joint ventures with for-profit entities and physicians, such as ambulatory surgery centers or imaging centers.


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Value-Based Arrangements

We work closely with our clients when investigating or implementing strategies to successfully navigate value-based reimbursement arrangements. Health care providers who can demonstrate their ability to deliver high-quality care in a cost-effective manner can realize significant financial upside, all while ensuring well-coordinated, high-quality care to their patients. When clients are successful at implementing a value-based model, the result is the delivery of appropriate care, at the appropriate time, at the most appropriate site of service, all while avoiding unnecessary duplication of services and preventing medical errors. Providers will also be able to share in the savings it achieves for the Medicare program.

The collaboration needed to create and operate a successful value-based organization requires significant investment in infrastructure, careful planning, and consideration of a number of legal issues, including concerning tax, antitrust, self-referrals, kickbacks, limitations on gain-sharing, and the regulatory criteria for becoming and continuing as a value-based model for enhanced reimbursement. Our attorneys are experienced in advising clients in the transition to value-based reimbursement, including with respect to compliance in those related areas of law.


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Venture Capital & Emerging Companies

We provide strategic legal counsel to emerging growth companies in the health care and life sciences industries, as well as to technology incubators, angel investors, investment banks, and venture capital firms that invest in those companies. Our experience with emerging health care companies and their venture capital investors spans the entire life cycle of the companies, from organization through financing and acquisition transactions and liquidity events.

We also provide holistic and creative solutions to venture capital investors seeking to invest in new and disruptive technologies or business models in the health care and life sciences industries.


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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.
  • Represented South Carolina hospitals, ambulatory surgery centers, physicians, radiation therapy centers, imaging centers, and nursing homes in CON matters.
  • Obtained favorable decisions in contested CON cases before the South Carolina Department of Health and Environmental Control, the South Carolina Administrative Law Court, and the North Carolina Division of Health Service Regulation.
  • 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.

Information Technology, Electronic Medical Records & Privacy

  • Represented the winning bidder in a 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.
  • Defended hospitals, medical records companies, and other providers in HIPAA and common law breach of privacy claims.

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 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 physician's 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.

Mergers, Acquisitions & Joint Ventures

  • Represented buyer of health services businesses in series of strategic "roll-up" 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 to a joint operating agreement.

Reimbursement

  • Enjoined program changes announced by a state's Medicaid agency that would have seriously affected industry providers.
  • Defended hospitals in class actions concerning third-party reimbursement claims. 

Tax-Exempt Hospitals & 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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Professionals

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