Health & Life Sciences

Transcription

1 Health & Life Sciences Overview Taft s Health and Life Sciences group provides comprehensive and innovative legal services, assisting a wide range of health care providers and life science businesses in the rapidly evolving health care industry. Our group includes teams that understand the business and legal challenges facing a variety of industry segments: Hospitals and health systems. Academic medical centers. Research institutions. diagnostic facilities. Biotechnology companies. Financial Institutions. Physicians, group practices and individual professionals. Federally Qualified Health Centers. Long-term care, including nursing homes and assisted living facilities. Durable Medical Equipment suppliers. Home health agencies and hospices. Ancillary providers, such as ambulatory surgery centers, laboratories and Accountable care organizations and clinically integrated networks. Pharmaceutical and medical device companies. Health Care Trade Associations. Healthcare consulting organizations. We counsel our clients in all aspects of the increasingly complex regulatory landscape, guide them through a broad range of transactions and represent them in a variety of adversarial proceedings, as further described below. Gregory W. Bee (513) [email protected] Dave Bromund (317) [email protected] Catherine T. Dunlay (614) [email protected]

2 Taft s health and life sciences attorneys regularly speak to and write for industry groups, clients and other lawyers. Our attorneys are active participants and/or leaders in the American Health Lawyers Association (AHLA) and other health care industry organizations such as Healthcare Financial Management Association (HFMA). Honors Eight of Taft s attorneys located throughout Ohio and in Indiana are recognized as Best Lawyers in Health Care Law in the 2015 edition of Best Lawyers in America. Two of Taft s Illinois attorneys are recognized as Leading Lawyers in Health Law by Leading Lawyers. In the U.S. News and World Report Best Lawyers "Best Law Firms" rankings, Taft's Health Care Law practice was honored as a Metropolitan First-Tier practice in Cincinnati. In addition, Taft received top honors as a U.S. Health Law Practice by the American Health Lawyers Association. Elizabeth A. Kastner (614) [email protected] Representative Services We provide our health care provider and life science business clients with sophisticated advice and services, manifesting experience in many diverse areas, including: Transactions Forming and operating clinically integrated networks and accountable care organizations. Mergers, acquisitions, sales, consolidations and joint ventures. Restructuring, including financing under the HUD LEAN program. Provider affiliation negotiations, structuring and documentation. Establishing new hospitals and health care facilities. Establishing ancillary businesses for physician practices. Health care facility lease and management arrangements. Borrower and lender representation in the financing (and re-financing) of healthcare facilities and life sciences companies. Corporate organization and restructuring. Barry Maram (312) [email protected] Timothy P. Nagy (614) [email protected]

3 Non-compete agreements. Ownership and succession issues. Licensing and sub-licensing (in/out). Strategic partnership agreements, supply chain agreements and consulting agreements. Health Care Operations Physician employment and compensation, including incentive-based compensation. Medical Staff Bylaws, rules and regulations and credentialing issues, including peer review. Governance tax-exempt organizations, public entities and closely-held entities. Conflicts of interest. including EMR donation programs. Clinical co-management agreements. Call coverage agreements. Provider Hospital Privileges Issues. Hospital-based physician contracts. Hospital purchasing contracts. Clinical trial/study contracts. Managed care contracting, including Medicare Part D, Medicaid MCO and PBM contracting, and pay-for-performance and shared savings programs. Assisting companies, universities, research institutions, incubators and Health information technology, E-prescribing and electronic medical records, scientists in protecting, developing and commercializing intellectual property rights in a wide range of technical areas, including medical devices, genetics, molecular biology, pharmaceuticals, bioremediation, e-commerce and software. Eric M. Simon (216) [email protected] Regulatory Compliance State licensure. Certificates of Need.

4 Corporate compliance plans, audits and monitoring. internal audits and self-disclosures. agencies. and compliance with other FDA and HHS regulations. Meaningful use. FDA compliance. Fraud and abuse, Anti-Kickback and Stark Law compliance, including Billing compliance, audits and reporting of overpayments. EMTALA (Emergency Medical Treatment and Active Labor Act). HIPAA, HITECH and other patient privacy and security regulations. Healthcare provider representation before local, state and federal regulatory Medical research issues, including clinical trials, human subject protections Bioethical and legal issues associated with data and tissue repositories, the development of products and practices to support personalized medicine, organ procurement and transplantation, stem cell research and genetic engineering. Antitrust. Sales and marketing regulations. Provider-based status and under arrangements requirements. Medicare and Medicaid enrollment, CHOWs and reimbursement. Nursing home licensure/regulation. Tax and tax exemption. Health care reform. Adversary Proceedings Representing healthcare issues before the state legislature. Administrative proceedings and appeals. False Claims Act litigation, including qui tam actions. Commercial and business litigation. Arbitration and other alternative dispute resolution. of sponsors, investigators and IRBs). Medical staff fair hearings. Medical research proceedings, including FDA enforcement actions (defense

5 Medicare and Medicaid appeals. White collar criminal defense. Representing providers in claims relating to health care fraud and abuse. Payer disputes, settlements and litigation. E-discovery. Taft's health and life science attorneys are contributing authors to Managed Market Access Blog which provides updates and analysis on a wide range of pharma issues.