Health Care and Life Sciences
Between emerging research, innovative biotechnology, changing payment and delivery models and evolving regulations and requirements, the health care and life sciences industry has no status quo. Organizations of all sizes and from all corners of the market need comprehensive and innovative legal services that can anticipate and adapt to the evolving complexities of technology and the regulatory and business landscape.
Our locally and nationally recognized team of health and life sciences attorneys counsel clients through the increasingly complex spectrum of legal issues facing these businesses. And, through connections to the American Health Lawyers Association (AHLA) and the Healthcare Financial Management Association (HFMA) and our ongoing relationship with industry leaders, groups and publications, our team is uniquely in-tune with the ever-changing business and legal challenges that impact the life sciences industry today and in the future.
Our group provides clients with sophisticated advice and services, manifesting experience in many diverse areas and across a variety of industry segments, including:
- Hospitals and health systems.
- Academic medical centers.
- Research 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 diagnostic facilities.
- Accountable care organizations and clinically integrated networks.
- Pharmaceutical and medical device companies.
- Biotechnology companies.
- Health care trade associations.
- Healthcare consulting organizations.
- Financial institutions.
Several Taft team members have garnered recognition for their skill in the health care and life sciences industry. Recognitions include Best Lawyers in Health Care Law in the 2017 edition of Best Lawyers in America, Leading Lawyers in Health Law by Leading Lawyers and special recognition for Health Care Law by Super Lawyers. Furthermore, our Health Care Law practice was honored as a Metropolitan First-Tier practice in Cincinnati and Columbus and National Second-Tier by Best Lawyers, Best Law Firms.
Taft provides a full range of services in order to assist our clients with a variety of transactions involving their business and organizations.
Our transactional services experience includes the following:
- 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 developing new health care facilities.
- Financing (and refinancing) with private lenders and government programs for the acquisition or development of 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.
- Non-compete agreements.
- Ownership and succession issues.
- Licensing and sub-licensing (in/out).
- Strategic partnership agreements, supply chain agreements and consulting agreements.
Health Care Operation Services
Taft counsels clients in support of both strategic and day-to-day operational matters.
Our health care operation services include:
- 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.
- Health information technology, e-prescribing and electronic medical records, 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.
- General counsel services to address legal issues arising in the ordinary course of business operations.
- Assisting companies, universities, research institutions, incubators and 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.
Regulatory Compliance Services
Regulatory compliance is a central focus for all of our clients in the health care and life sciences market space. We work closely with clients to ensure their continuing compliance with an ever-changing set of regulations and to keep them up-to-date with respect to the latest regulatory developments affecting them.
Taft lawyers are adept at handling these regulatory compliance services:
- State licensure (initial and changes in providers).
- Certificates of need (planning, application preparation, and prosecuting and defending administrative and court appeals).
- Corporate compliance plans, audits and monitoring.
- Fraud and abuse, Anti-Kickback and Stark Law compliance, including internal audits and self-disclosures.
- 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 agencies.
- Medical research issues, including clinical trials, human subject protections and compliance with other FDA and HHS regulations.
- Meaningful use.
- FDA compliance.
- 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.
- 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 Services
We work hard to help our clients structure and operate their organizations smoothly and without legal disruption. However, disputes are sometimes unavoidable. When needed, we go to bat for our clients and zealously represent them in any adversarial matters and proceedings in which they find themselves.
We regularly assist our clients with these adversary proceeding services:
- Representing health care 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.
- Medical research proceedings, including FDA enforcement actions (defense of sponsors, investigators and IRBs).
- Medical staff fair hearings.
- Medicare and Medicaid appeals.
- Representing providers in claims relating to health care fraud and abuse.
- White collar criminal defense.
- Payer disputes, settlements and litigation.
Taft's health and life science attorneys are steadfast in our commitment to the ever-changing landscape of the industry, working hard to keep our clients and fellow attorneys abreast of any recent developments and how it may affect their operations.
- Corporate Compliance and White Collar Criminal Defense
- Crisis Management
- Employee Benefits and Executive Compensation
- Employment Law
- Intellectual Property
- Labor Relations
- Mergers and Acquisitions
- Patent Prosecution
- Pharmaceutical and Life Sciences Litigation
- Privacy and Data Security
- Real Estate
- Trademark and Copyright Prosecution
- Venture Capital and Emerging Companies