Health Care

Our attorneys are experienced in assisting hospitals, physicians, physician groups, long-term care providers, behavioral health providers, developmental disability providers, home health agencies and other health care providers in navigating the complex regulatory scheme associated with today’s health care market.  Some of our health care attorneys are former general counsel of state agencies who have represented both the regulator and the regulated entity.  We also have an experienced registered nurse attorney with prior health care healthcare experience.  Their unique perspectives can prove invaluable when clients make strategic decisions in the regulatory context.

We regularly represent health care providers before federal and state agencies, county authorities, local health districts and accreditation bodies, including the Joint Commission and the Community Health Accreditation Program (CHAP).  We also participate in the regulatory rule-making process from the ground up, so that our clients can understand what is important to the regulator, and why.  This knowledge frequently is helpful in resolving disputes with regulatory bodies.

Not all health care providers are alike, and neither are health care litigators.  Our health care litigators understand the unique business and regulatory issues that affect our individual health care clients and provide carefully tailored advice and assistance.  Learn more here.

Our health care attorneys partner with our tax attorneys to provide federal, state, and local income tax counseling, sales and use tax exemption planning, and tax-planning services for health care providers, especially tax-exempt health care organizations.  We regularly counsel our health care clients on all organizational and operational aspects of obtaining and maintaining tax exemption, structuring mergers and reorganizations, for profit subsidiary planning, joint ventures of nonprofit and for profit entities, nonprofit governance issues, unrelated business income tax (UBIT) planning, fundraising programs, charitable solicitations, charitable sales promotions, planned gifts and structuring compensation arrangements to comply with the intermediate sanctions rules.  We have assisted in obtaining property tax exemptions, defending clients when property tax exemptions are threatened, and in administrative and judicial appeals related to their property tax exemption.  Learn more here.

Our firm currently serves as legal counsel to multiple large health care provider trade associations throughout Ohio and Pennsylvania.  These trade association relationships span many decades.  We are honored to be their trusted legal advisor.  We regularly work with trade association leaders and their boards to solve the systemic issues faced by their members.  We assist health care trade associations with the many issues that arise in a highly regulated industry.  We also are very fluent in state budgeting processes and assist the associations with their industry legislative initiatives, drafting and analysis.  Our client trade associations trust us as their preferred legal counsel to address their legal issues, as well as those of their individual members.

Our regulatory and compliance experience complements our role as counsel to clients in all transactional matters, including hospital/physician joint ventures; acquisition of long-term care facilities and other providers; creation and operation of diagnostic testing facilities; equipment and space lease arrangements; hospital and physician practice acquisitions; personal services and physician employment agreements; and physician recruitment programs.  We counsel clients on ownership/investment issues, structural and operational considerations, and reimbursement concerns to ensure compliance.

We regularly evaluate proposed transactions of all shapes and sizes.  We are acutely aware of the importance of fraud and abuse compliance issues presented in virtually all transactions involving our health care clients and approach each issue with a practical, skilled eye towards assisting our clients in achieving their objectives within the bounds of the law.  In doing so, we analyze their compliance with the federal and state fraud and abuse laws and provide guidance on how to properly structure (or amend, as needed) each arrangement to comply with applicable authorities.  We also have experience analyzing other relevant state laws, including corporate practice of medicine and fee splitting laws.

Our attorneys are highly experienced in the area of health information privacy and the confidentiality of medical information.  This includes the Health Insurance Portability and Accountability Act (HIPAA) of 1996, The Health Information Technology for Economic and Clinical Health Act (HITECH), the Confidentiality of Substance Use Disorder Patient Records regulations (42 C.F.R. Part 2) and other federal and state privacy laws.

We have counseled and helped providers and covered entities, including physicians, hospitals, healthcare trade associations, behavioral health providers, substance use disorder providers, developmental disabilities providers and employee health benefits providers tackle a wide range of healthcare privacy issues including the following:

• Advising clients regarding appropriate uses and disclosures of protected health information
• Creating HIPAA privacy and security policies and procedures
• Performing HIPAA Audits
• Drafting and negotiating Business Associate Agreements
• Drafting Notice of Privacy Practices
• Conducting Risk Assessments
• Responding to breaches and potential breaches
• Quashing inappropriate subpoenas

In addition, as health care has become an increasingly technological business, our attorneys have advised providers and third-party services concerning information systems privacy and the interplay between technology and corporate compliance.  This includes advising clients in the following areas:

• Telehealth, including scope of practice and payment issues
• Interoperability and EHR contracting, implementation and transitions
• information blocking prohibition under the 21^st Century Cures Act
• Health Information Exchange (HIE) issues
• General Data Protection Regulation (GDPR) compliance
• Complex data sharing arrangements

To learn more about our comprehensive data strategy, privacy and security practice, click here.

We advise clients on issues related to federal and state reimbursement systems, including coding and billing issues Medicare contracting, participation, coverage, reimbursement (including reassignment of the right to payment), and appeals, Medicaid contracting, coverage and reimbursement, rate setting, cost reporting and reconciliation, reimbursement of provider-based entities and compliance issues.  We are experienced in representing clients before state Medicaid agencies, the Centers for Medicare and Medicaid Services, Medicare contractors, the Office of the Inspector General and the United States Attorney’s Office.

Our experience helps us plan and structure transactions to minimize fraud and abuse implications, while at the same time achieving our health care clients’ desired business goals.  We regularly evaluate transactions and analyze their compliance with the Medicare and Medicaid fraud and abuse statutes, such as the Anti-Kickback Statute and safe harbor regulations, and the Stark Physician Self-Referral Laws and applicable exceptions.  Our experience in this area complements our role as transactional counsel to clients on hospital/physician joint ventures, including the operation of diagnostic imaging facilities, equipment lease arrangements, physician practice acquisitions and physician recruitment programs.  We know the ins and outs of health care deals, and we steer our clients away from the pitfalls that trap the unwary.

We also assist clients with conducting internal fraud and abuse investigations and audits, as well as governmental investigations, audits, and settlements, and provide ongoing consultation regarding compliance with corporate integrity agreements (CIAs).  Through on-site reviews and evaluations of contracts and business relationships between hospitals’ and physicians’ referral sources, we identify and analyze potential fraud and abuse concerns.  We then assist our clients in developing compliance programs and policies to educate staff (physician and non-physician), to prevent illegal activity by uninformed employees, to recognize and address compliance issues as they arise and to minimize client exposure to prosecutions and penalties.  Learn more about litigation in this area.

Our attorneys routinely assist providers with both governmental and commercial reimbursement disputes.  We have extensive knowledge of governmental health care reimbursement programs, as well as the complex administrative processes necessary to assist our provider clients with responding to audits and related appeals.  We partner with our clients through every step of payor audits, beginning with preparing and responding to the initial request for records, and continuing through the appeals process at all levels of appeals.

Our firm represents the interests of our health care clients in connection with both state and federal legislation.  We have more than 50 lawyers with legislative experience at one or more levels of state and federal government, many of whom have testified before committees of Congress or the Ohio General Assembly.  We also offer health care clients full service representation before city councils, county commissioners and township trustees.  We help shape legislation by drafting bills, amendments and testimony for sponsors and witnesses.  Our lawyers have extensive knowledge of the legislative process, which they use to develop strategies to effectively support, oppose or amend specific legislation of interest to our clients.  We often partner with our colleagues at Vorys Advisors to bring together legal knowledge and legislative strategy in order to advance our client’s interests.  Learn more here.

Our attorneys have extensive experience representing organizations and professionals involved in the field of behavioral health (mental health and alcohol and drug treatment and prevention), developmental disabilities (DD) and child welfare.  We represent a variety of statewide trade associations in the behavioral health and DD fields on numerous issues, including systemic regulatory and reimbursement matters, as well as the development and implementation of Medicaid waiver programs.  We work with trade association leadership on a day to day basis and understand the challenges faced by associations and their members not only with regard to specific regulatory issues but also as employers in a highly regulated industry.

We represent providers with Medicaid managed care contracting issues and understand the unique challenges that providers face as Medicaid managed care is rolled out to include specialty populations where the individuals served are particularly vulnerable.

We have represented many providers before state agencies, have negotiated contracts with various payors and have provided reimbursement counseling on complex Medicaid and Medicare reimbursement matters.  Our attorneys not only understand the more traditional institutional programs, but also are very experienced in the home and community-based Medicaid waiver programs, including 1915 and 1115 Medicaid waivers, as well as all types of community-based programming.

Our firm assists providers in health care operations, including advising institutions and their medical staffs and boards on governance issues.  Our attorneys represent hospitals and physicians in matters such as medical staff bylaws, rules and regulations, institutional review boards, TJC accreditation, advance directives, medical records, bioethics and other operational issues.

Whether the matter involves the day-to-day operations of a hospital or health system or issues associated with regulatory compliance, complex litigation, corporate compliance, board governance, medical staff issues, fraud and abuse or payor and reimbursement arrangements, our attorneys are fully equipped to address client needs.  We serve as outside counsel for many hospitals, health systems, nursing homes and other long-term care facilities, skilled nursing facilities and other health care institutional providers.  We also represent physicians, physician groups, home health agencies, ambulatory surgery centers, diagnostic centers and other outpatient service providers.  We also assist in creating and implementing professional liability self-insurance plans.

Academic Medical Centers

Vorys has extensive experience dealing with the unique issues faced by academic medical centers.  We represent medical schools, teaching hospitals, faculty practice plans, research institutes and affiliated organizations throughout Ohio and around the country.  We have assisted academic medical centers in all aspects of their operations.  Our attorneys have extensive knowledge and experience in fraud and abuse, federal Anti-Kickback Statute and Stark Physician Self-Referral Laws.  We counsel our academic medical center clients in connection with the formation, operation, and tax exemption of faculty practice plans, internal compliance audits, the consequences of the various payment arrangements that exist among teaching hospitals, medical schools, and faculty physicians and the increasingly complex interplay of Institutional Review Boards, the FDA and industry sponsored clinical trials and human subject research.  All of this, coupled with Vorys’ extensive history representing colleges and universities, provides Vorys the background and experience to offer our academic medical center clients comprehensive legal representation.

Joint Ventures/Hospital-Physician Collaborations

Our lawyers provide advice on health-related business transactions, such as structuring joint ventures between hospitals and physicians, forming and re-syndicating ambulatory surgery centers, physician employment and structuring and operating other ancillary service providers, including diagnostic imaging centers.  We are also experienced at unwinding joint ventures in the event that subsequent regulatory changes raise legal issues or frustrate the strategic purpose of the joint venture.  We understand the complexities of hospital-based and freestanding arrangements, and we counsel clients on ownership/investment issues, structural and operational considerations, supervision requirements and reimbursement concerns to ensure compliance with the array of regulatory issues that affect health care transactions.  Most importantly, we listen to our clients and draw on our experience and creativity to provide solutions that achieve their business objectives.

Managed Care

Our attorneys are experienced in dealing with the issues that arise in the relationship between health care providers and managed care organizations.  We have assisted health care providers with the design and implementation of integrated delivery systems, including physician-hospital organizations and management services organizations.  We have created and represented health maintenance organizations (HMOs) and health insuring corporations (HICs).  We also have assisted health care clients with contract negotiations with managed care organizations.

Our attorneys have assisted and advised a variety of healthcare practitioners, including physicians, nurses, advance practice nurses, physician’s assistants, social workers, counselors, substance use disorder providers and others, regarding scope of practice, ethical and billing issues.  We have represented and defended licensed practitioners in actions and investigations brought by state licensing boards.  We have extensive knowledge of the wide range of state and federal laws and regulations which affect Practitioners, and their ability to care for their patients and bill for their services.  Our attorneys provide a wide range of services, including contract review, regulatory analysis and business advice to aid these practitioners in delivering services.

Long Term Care Facilities

Our attorneys understand the complexities of the long-term care business.  We represent nursing homes, residential care/assisted living facilities, independent living facilities, continuing care retirement communities (CCRCs), intermediate care facilities for individuals with intellectual disabilities and group homes.  We frequently counsel clients on regulatory issues, including licensure and certification, certificate of need, compliance, survey and enforcement, changes of ownership, Medicare, Medicaid, and business and clinical operations.

Our attorneys are well versed on the latest regulatory initiatives that may impact long-term care providers and have represented providers in matters pending before numerous federal and state regulatory bodies and provide expert assistance with governmental and internal investigations and audits.  We are also experienced in transactional matters, and assist clients with dispositions, mergers, acquisitions and complex joint ventures, including assistance with Medicare, Medicaid, diligence, state and federal filings, and preparation and negotiation of contracts.

Home Health

Our attorneys frequently counsel existing and startup home health agencies regarding compliance, surveys, licensing and certification, accreditation, changes of ownership and locations, business and operational issues, contracts, defense of fraud and abuse allegations and Medicare Conditions of Participation issues.  We also assist home health agencies with policies and procedures, reimbursement issues, and audits and overpayment issues.  Our attorneys have vast experience with transactional matters, including acquisitions and complex joint ventures, and assist with diligence, Medicare, state and federal filings and contracts.

Hospice and Palliative Care Providers

Our attorneys have broad experience in the full range of legal and regulatory issues impacting hospice and palliative care providers.  Our attorneys counsel hospice and palliative care providers on regulatory matters, surveys, audits, complex reimbursement, contracts, including agreements with other providers, DME, and vendors, corporate structuring, program development and transactions, including mergers, acquisitions and complex joint ventures.  Our attorneys are also experienced in fraud and abuse issues (Anti-kickback Stark and False Claims Act) and Medicare Conditions of Participation as they relate to specific hospice program issues.