Assisting with the legal issues faced in today's complex corporate world.
Buchanan Ingersoll & Rooney's health care attorneys are committed to the needs of academic medical centers, teaching hospitals and universities. We draw upon the knowledge that has developed from years of representing health care clients and upon the skills of our attorneys.
To better address the diverse needs of academic medical centers, teaching hospitals and universities, Buchanan has brought together attorneys from across the country. These attorneys combine their knowledge and years of practice to counsel clients in technology and biotechnology, corporate structure and governance issues, tax matters, labor and employment issues, government relations, reimbursement, regulatory matters, fraud and abuse and litigation.
The firm's lawyers have experience in various technical fields that are important to our clients, including medical and diagnostic equipment, computer hardware and software, genetic research and engineering, pharmaceuticals, drugs and drug-delivery systems, robotics and ultrasound devices. The firm's lawyers have been involved with commercial transactions involving technology and intellectual property rights. We regularly help clients:
- Obtain, maintain, protect and transfer intellectual property rights for products, processes and services.
- Develop collaborations and strategic alliances between research-oriented universities and entrepreneurial companies in connection with a range of technology transfer, joint development, licensing and commercialization matters.
- Obtain copyright protection and provide counsel concerning freedom to publish issues raised by faculty.
- Negotiate multimillion-dollar lease agreement for cutting-edge PACS technology system providing digital imaging of patient's radiology tests.
- Develop comprehensive information technology outsourcing arrangements and acquire and implement significant software assets.
- Undertake Web-based degree granting distance learning initiatives.
We help our clients interpret and apply the complex regulatory framework governing clinical research, innovations in biotechnology, and relationships among research institutions, sponsors and investigators. We counsel clients regarding:
- Health care coverage and reimbursement issues during a product's development and compliance with rules regulating marketing and sales of health-care-related products.
- Scientific misconduct questions, fraud and misappropriation of intellectual property rights.
- Human subject protections, research integrity, investigator conflicts of interest, Medicare reimbursement, use of approved drugs for unapproved uses and adverse event reporting.
- Biomedical ethical and legal issues related to stem cells, cloning and the human genome.
- Strategies to address regulatory issues, conduct regulatory compliance audits and provide counsel concerning governmental investigations.
- Institutional Review Boards ("IRB") and issues of regulatory compliance.
We regularly assist clients to determine the most appropriate form of corporate governance and corporate structure to meet their objectives. Developing the appropriate legal and financial relationships are critical in this regard. The firm's lawyers are regularly involved in:
- Structuring relationships among components of academic medical centers, faculty practice plans, teaching institutions, foundations, colleges and universities.
- Handling mergers of medical staff and faculty at multiple institutions and formation and restructuring of faculty practice plans.
- Developing the structure that best insulates the client's assets with regard to liability insurance concerns.
- Advising on fiduciary duties of trustees and directors and governing body conflict of interest matters.
- Building and dismantling regional networks and alliances.
- Renewing and revising affiliations agreements.
- Advising on academic medical center mergers and acquisitions, including addressing issues raised by states' attorneys general.
We offer guidance and advice to our clients on myriad tax related issues including:
- Qualifying for and maintaining tax-exempt status.
- Structuring deferred compensation and profit-sharing arrangements for not-for-profit entities.
- Structuring transactions and drafting documents for partnerships and other joint ventures between not-for-profit entities and third parties.
- Assisting not-for-profit clients with tax exempt financing.
- Representing not-for-profit hospitals in tax controversy matters.
- Advising clients in multi-million dollar tax-exempt bond refinancing deals.
We regularly represent our clients with a range of employment and related issues. We counsel our clients on:
- Addressing affirmative action and equal employment opportunity issues.
Faculty practice plans.
- Mediation and grievance processes, serving either as legal counsel or on the mediation/grievance panel.
- Faculty, staff, student and resident handbooks and contracts.
- Day-to-day human resources and benefits issues, union negotiations, grievances, union organizing campaigns and NLRB complaints.
- Wage and hour complaints, OSHA inspections and sanctions and employment and disability discrimination complaints before state and federal agencies and courts.
We are active in representing the interests of our clients before Congress and the agencies of the state and federal government on a variety of legislative, regulatory and appropriations matters. We aid clients with:
- Assisted in obtaining more than $280 million in state funding for Florida's six statutory teaching hospitals.
- Assisted in securing $10 million in capital funding to support the construction of a pediatric oncology unit at the new Children's Hospital in Pittsburgh.
- Planning government appropriation strategies.
- Preparing funding requests.
- We successfully lobbied for the creation of a dedicated revenue source for indigent medical care.
Clients are dependent upon reimbursement streams to support their threefold mission to educate future health practitioners, conduct medical research and provide services to those in need. In addition to handling routine health provide reimbursement issues, we help our clients with:
- Reimbursement matters related to new technology.
- Upper payment limit and disproportionate share programs for academic medical centers and faculty practice plans to maximize Medicaid reimbursement.
- The rules related to resident and intern supervision and reimbursement for graduate medical education.
- Reimbursement matters related to organ transplant program.
- A host of reimbursement issues such as provider-based status, incident to billing, related parties, purchased diagnostic tests, telemedicine and global surgery billing.
- Written compliance plans with hospital policies and procedures that reflect federal and state statutes and regulations regarding direct and indirect graduate education reimbursement.
Some of our attorneys have prior experience representing government agencies or have clinical training as nurses and pharmacists, which enables us to deal with the intense scrutiny of clients currently carried on by the federal and state governments. We:
- Assist clients on how to efficiently comply with the technical, privacy and security requirements of the Health Insurance Portability and Accountability Act (HIPAA).
- Represent health care practitioners before state licensing boards.
- Counsel teaching facilities in connection with PATH audits.
Fraud and Abuse
Clients are under increased pressure to guard against allegations of Medicare and Medicaid fraud and abuse. Our attorneys have experience in dealing with questions under federal/state false claims, Stark and anti-kickback laws, as well as the many other statutes and regulations governing them. We assist clients with:
- Corporate compliance programs.
- Medicare/Medicaid audits.
- Grand jury, OIG and Medicaid fraud unit investigations.
- Litigation, negotiation and settlement of government claims.
It is our goal to proactively work with our clients to avoid, manage and, ultimately, resolve conflicts. To accomplish this goal, our group has litigators that have handled commercial disputes, employment and labor disputes, contractual disputes in federal and state courts, as well as administrative agencies and alternate dispute resolution. Our litigators are versed in:
- Corporate governance and control issues at the board and/or member level arising from disputes over governance.
- Medicare and Medicaid reimbursement appeals, including allegations of overpayments and recoupment of underpayments.
- Litigation with states' attorneys general regarding issues of non-profit corporate governance and application of charitable trust principles to nonprofit entities.
- Peer review matters.
- Defending against civil fraud claims, whistleblowers and qui tam actions.
On a regular basis we handle questions and issues for clients pertaining to a wide range of operational issues, including:
- Drafting and/or review of contracts with vendors, outsourcing service providers or managed care organizations.
- Drafting and/or reviewing policies and procedures in all areas, including incident review and investigation and quality assurance.