|
Services Available
Manatt’s health law professionals have comprehensive industry knowledge and experience – in health care management, in government at all levels, in the health care field itself. When we advise you on any issue, from staff credentialing to HIPAA compliance, it’s with an in-depth knowledge of the law and its practical application to operations and regulation. Much of our experience has been in the fast-paced, complex health care environments of California and New York, and includes:
§ Work as in-house counsel and administrators at numerous hospitals and hospital systems, including the New York City public hospital system and an operating partnership of four major New York City primary care and teaching hospitals.
§ Executive positions with a variety of other industry participants, including a major health and group insurer, a national managed care contracting and physician management company, and companies specializing in health care technology and capital management.
§ Public policy leadership in the creation of health programs and systems, such as the creation of the New York City Primary Care Development Corporation (a public-private primary care partnership), the establishment of New York’s state Medicaid managed care and child health plans, and the overhaul of the District of Columbia’s system of licensing and regulating health care professionals and HMOs.
§ High-ranking government positions, such as Deputy Assistant Secretary for Legislation at the former Department of Health, Education and Welfare, Deputy California Attorney General (responsible for overseeing all conversions of non-profit hospitals in the state), Assistant Counsel for the New York State Department of Health and Human Services, and Deputy General Counsel for the New York State Office of Mental Retardation and Developmental Disabilities.
§ Hands-on health care involvement as a registered nurse, as assistant to the director of the UCLA Medical School’s Center for Ulcer Research and Education, and as a bioethics researcher at the University of Southern California.
§ Leadership of major professional associations, including the California Society for Healthcare Attorneys, the Health Law Section of the New York State Bar and the Healthcare Committee of the American Bar Association’s Antitrust Section.
Major Clients
We serve a broad spectrum of clients across the United States. Among them are the largest non-profit hospital system in California, several national health facility chains, an international clinical laboratory company, a major academic medical center in the Mid-Atlantic region, national managed care and insurance enterprises, a major New York health system, and a Pennsylvania healthcare system. Our lawyers provide operational and regulatory counsel to the full range of health care providers, including:
§ Multi-hospital systems;
§ Individual public and private hospitals;
§ Medical research institutions;
§ Academic medical centers;
§ Physician organizations;
§ Alternative healthcare delivery organizations;
§ Skilled nursing facilities;
§ Long-term care providers;
§ Home healthcare agencies;
§ Ambulatory care providers; and
§ Alcohol and drug treatment centers.
We also advise a variety of other institutions and businesses active in the healthcare field, such as:
§ Medical technology and pharmaceutical companies;
§ Biotechnology and research organizations;
§ Managed care organizations;
§ Life sciences venture capital funds;
§ Healthcare trade associations;
§ Governmental entities; and
§ E-health and e-commerce companies.
Our counsel is as broad as the industry itself, including specialized matters unique to healthcare providers and general business concerns common in any highly competitive environment. The following summarizes our primary areas of counsel.
Antitrust
We help health care professionals properly structure and operate provider contracting arrangements (the alphabet soup of IPAs, JOAs, PHOs, PPOs and many others) that effectively compete in today’s market without violating antitrust guidelines. Our attorneys also advise hospitals and medical centers on mergers and acquisitions, making sure they are positioned to avoid investigation or litigation of antitrust claims over delivery of health care services. Our team members include the author of the first book ever published on the application of the antitrust laws to the healthcare industry, and our lawyers have spoken and published frequently on this topic.
Business Law
Manatt attorneys are at the forefront of new business endeavors in the healthcare industry. We work with e-health Internet companies as they deal with their formation, financing, multi-state licensure, HIPAA and other privacy, confidentiality and security requirements. Our work also encompasses a variety of other innovative business entities, including the formation of university consortia for research and investment projects. We have extensive experience in acquisitions of publicly held and private healthcare businesses, including leveraged buy-out transactions as well as mergers and divestitures, and often assemble a multidisciplinary team of lawyers to guide clients through the complex legal, regulatory and business issues involved.
Our assistance with the day-to-day business law issues faced by healthcare clients includes real estate leases on behalf of landlords and tenants, equipment leases and financing, supply and service contracts, litigation, employment and personnel issues. In business matters unique to the industry, we advise on government reimbursement, non-governmental payor contracts and other business law issues that repeatedly arise in the operation of healthcare entities.
Corporate Reorganization
As pioneers in applying corporate reorganization principles to healthcare providers, our health law attorneys routinely have advised both financially stable and financially troubled healthcare organizations, as well as lenders, on corporate reorganization and financial restructuring. Typical of our work is Manatt’s representation of the California Department of Managed Health Care (the regulatory body that oversees all managed care in California) in connection with large healthcare Chapter 11 proceedings such as In re MedPartners Provider Network, Inc., In re KPC Global, and In re Maxicare.
Emerging Healthcare Technologies
Our attorneys represent emerging medical technology and life sciences companies, assisting them with their entity structure, intellectual property licensing and protection, employee contracting, public and private financing, and mergers and acquisitions. We have organized and obtained financing for a variety of healthcare technology start-ups, taken them through successive rounds of venture capital financing, formed joint venture and licensing arrangements with larger companies, represented them in their initial public offerings and subsequent financings, advised them regarding securities compliance issues and represented them in mergers valued in the billions of dollars. Manatt also represents venture capital funds that invest in medical technology and life sciences companies, helping them with organizational, investment and operational issues.
Financing
With one of the nation’s leading financial institutions practices, Manatt is experienced in handling a variety of financing transactions for our healthcare clients. Our attorneys serve as counsel for bond issuers and underwriters in a wide range of tax-exempt transactions as well as public offerings of equity securities, including limited partnership interests. We also arrange financing through various health facility authorities, secure federally insured mortgage loans, obtain venture capital, and assist with franchising arrangements and advance debt refunding transactions.
Fraud and Abuse, Restrictions on Referrals
Manatt attorneys have in-depth experience with the complex and often confusing laws that govern healthcare provider billing practices and ownership and referral relationships. Because fraud and abuse and self-referral concerns involve intense regulatory scrutiny and enforcement, we offer comprehensive advice regarding the structure of transactions, design and implement corporate compliance programs, conduct internal investigations, and assist in voluntary disclosures.
Manatt professionals represent healthcare entities and individuals in a variety of criminal, civil and regulatory proceedings, and in all phases of government investigations and prosecutions involving fraud and abuse allegations. We have comprehensive experience in this difficult law enforcement environment, and consistently obtain very favorable outcomes for our clients. Our lawyers help clients respond to search warrants, grand jury and administrative subpoenas, and civil investigative demands; represent individuals before grand juries; and handle pre- and post-indictment plea negotiations, proceedings, and sentencing.
Healthcare Delivery Systems
Using our extensive knowledge of the competitive and cost pressures facing healthcare providers, we help them to position themselves for survival by enhancing quality and expanding services. Our attorneys can analyze healthcare markets and formulate strategic plans that help clients grow by establishing new programs or business combinations. The range of service-expanding transactions that we guide is comprehensive, and includes:
§ Acquisition of and affiliation with (through ownership or by contract) other health systems;
§ Acquisition of ancillary and other service providers;
§ Development of tax-exempt medical clinics and other physician practice management organizations; and
§ Reorganization of corporate structures to respond to the financial and operational needs of a multi-entity system.
Because Manatt has wide-ranging financial institution contacts, we also facilitate our clients’ access to the capital necessary for successful completion of service expansions.
HIPAA
We regularly advise health care providers on their responsibilities to protect the privacy of patient health information under the Health Insurance Portability and Accountability Act (HIPAA). Our clients for HIPAA compliance counsel include hospitals, community health centers, mental health clinics, residential treatment programs, dialysis clinics, HMOs, insurance companies and trade associations, as well as a diverse group of “business associates” such as information technology firms, medical device marketers, IPAs and disease management companies. A key part of our compliance work involves conducting training sessions for provider personnel, so that they handle information requests and record security in compliance with the law. As part of this training our attorneys analyze where improvement in records privacy is necessary, draft privacy and security policies and procedures and prepare business associate agreements and privacy notices. Manatt has also provided strategic advice on HIPAA compliance issues as they involve the relationship between affiliated entities, the creation of organized health care arrangements and the designation of hybrid entities.
Joint Ventures
We help organize, structure and restructure many joint ventures among hospitals, physicians, ambulatory care providers, suppliers and other healthcare delivery participants, making sure that existing arrangements and new transactions comply with all aspects of fraud and abuse enforcement and regulation and antitrust guidelines.
Legislative and Administrative Law
Reflecting our extensive experience at the highest levels of government healthcare policy regulation, we are uniquely positioned to help shape federal and state health policy in ways that advance the interests of our clients. Our attorneys combine hands-on understanding of healthcare operations, the regulatory environment and the legislative process to craft, advocate and implement far-reaching solutions to complex policy problems. As part of maintaining a forceful presence in the regulatory and legislative arenas, we negotiate on behalf of clients before the U.S. Congress, state and local governments and quasi-governmental agencies. We also regularly scrutinize governmental actions at all levels, and help clients formulate and present testimony and other position statements that guide and shape the policymaking process.
Licensing, Certification and Accreditation
With years of experience in general representation of hospitals, long-term care providers and ancillary providers, Manatt attorneys have assisted clients in every aspect licensing and certification. We help clients prepare for Joint Commission and other accreditation surveys in this era of change, and represent them in appeals of accreditation decisions.
Litigation
Manatt assists hospitals, other health care providers and publicly traded health care companies with the full range of general business and specialized industry problems that result in litigation involving both private parties and government agencies, including:
§ Antitrust;
§ Contract disputes;
§ Creditors’ rights;
§ Employment and ERISA matters;
§ Environmental law and workplace safety;
§ False claims;
§ Fiduciary liability;
§ Fraud;
§ Government regulation and compliance;
§ Insurance coverage disputes;
§ Malpractice and professional liability;
§ Managed care disputes;
§ Privacy and ethics issues;
§ Provider contracting arrangements;
§ Real estate;
§ Reimbursement; and
§ Unfair competition
We help health care professionals properly structure and operate provider contracting arrangements (the alphabet soup of IPAs, JOAs, PHOs, PPOs and many others) that effectively compete in today’s market without violating antitrust guidelines or other restrictions that can result in a lawsuit. Working with Manatt’s business and health care attorneys, our litigators advise hospitals and medical centers on mergers and acquisitions, making sure they are positioned to avoid investigation or litigation of antitrust claims over delivery of health care services.
Fraud and abuse allegations relating to healthcare provider billing practices, ownership and referral relationships increasingly lead to litigation or administrative complaints. Manatt litigators are well qualified to advise providers on their responsibilities regarding the Stark Law, antikickback statutes, fraud and abuse safe harbors, Office of Inspector General (OIG) investigations and other enforcement investigations and proceedings. We help our clients respond to search warrants, grand jury and administrative subpoenas, and civil investigative demands, obtaining favorable outcomes at trial and through negotiation.
Long-Term Care
We understand the new political pressure that has greatly intensified the already tough enforcement environment for nursing homes, and help nursing home operators throughout the country deal with the often subjective and inconsistent enforcement of federal and state licensure and certification requirements. When our clients face investigations and sanctions from regulators (including terminations from the Medicare and Medicaid programs, bans on admission and civil monetary penalties) we are frequently successful at ending the action by negotiating a favorable settlement. When that is not possible, our attorneys have successfully defended long-term care providers in courts and administrative agencies throughout the country in survey enforcement disputes as well as proceedings alleging fraud and abuse violations. We are also effective advocates for long-term care providers who are faced with elder abuse lawsuits.
Managed Care
Our healthcare attorneys help managed care providers, employers, and health maintenance organizations, including various state managed care programs, deal with operational issues and the widespread legislative efforts to police managed care decision-making and increase the scope of coverage. We have participated actively in the development of HMOs, PPOs, and insurance ventures, including multi-state HMO operations. As a result, we can help any HMO client with issues involving regulatory compliance, provider and subscriber relations, and quality assurance.
Medical Staff Relations/Peer Review
Manatt attorneys provide a full range of legal services in the critical areas of medical staff peer review and governance. Our experts handle all phases of internal administrative actions and litigation involving credentialing of practitioners, as well as denial, suspension, reduction and termination of privileges and membership. We also advise clients on their reporting responsibilities to state medical boards and the National Practitioner Data Bank.
The range of staff relations issues that we handle is comprehensive. Our healthcare attorneys draft and revise medical staff bylaws, rules and regulations, and policies and procedures governing practitioner membership, privileges, obligations and right, medical staff leadership and functions, and medical staff relations with hospital administration and the governing body. In special situations, we help clients deal with impaired or disruptive practitioners, implement closed staffing arrangements and hospital-based physician contracts, address emergency department coverage issues, and educate physicians on medico-legal issues.
Medicare/Medicaid Reimbursement
Manatt healthcare industry attorneys have provided reimbursement counsel since the inception of the Medicare and Medicaid programs. We help clients interpret regulations and policies promulgated by federal and state agencies, enabling them to maximize reimbursement payments and representing them before Medicare and Medicaid agencies in disputes and investigations.
Non-Profit Organizations
Manatt lawyers regularly counsel tax-exempt healthcare systems, hospitals, and health plans, providing general advice to non-profit boards of directors, and also representing them in litigation. We provide expert-witness services in the areas of fiduciary obligations of officers and directors of non-profit corporations, and offer specific counsel on charitable trust law and officer, director and trustee liability. We have special experience in handling healthcare facility alliances and conversions from non-profit to for-profit status, in particular transactions involving transfer of non-profit hospital assets (which are subject to Attorney General regulatory review).
Pharmaceuticals and Biotechnology
Our attorneys represent pharmaceutical and biotechnology companies in all of their organizational, financial and licensing activities. We have organized and obtained financing for biotechnology start-ups, taken them through successive rounds of venture capital financing, formed joint venture and licensing arrangements with larger pharmaceutical companies, represented them in their initial public offerings and subsequent financings, advised them regarding securities compliance issues and represented them in mergers valued in the billions of dollars. In our regular representation of bio-pharmaceutical clients, we provide counsel in the human relations, real estate, contracting, litigation and regulatory issues common to all businesses, as well as those unique to the industry. We have represented non-profit organizations in their contracting and licensing activities, and formed university consortia for the achievement of significant biotechnology projects.
Physician Arrangements and Organizations
As traditional methods and structures of physician practice continue to evolve, we help physicians in all aspects of organizing, managing, and reorganizing medical practice groups. Our healthcare lawyers handle the most complex organizational matters, including developing alternative legal structures for multi-physician practices, and forming independent practice associations and other effective vehicles for contracting with managed care organizations and hospitals.
We also help physician groups with day-to-day operational issues and contract negotiations. Having worked extensively with physicians, hospitals, and hospital systems, our lawyers offer creative counsel on the complex relationships and issues physicians have with payors and other healthcare providers. We are fully experienced with joint hospital-physician relationships, and have worked with hospitals and hospital systems to develop integrated delivery of health services, including hospital-sponsored practice management services organizations and tax-exempt medical foundation clinics.
Taxation
We advise healthcare organizations on how federal and state tax laws affect their business and operations on such issues as:
§ Entity formation and liquidation;
§ Tax-free reorganizations;
§ S corporations;
§ General corporate and partnership taxation;
§ Executive compensation;
§ Employee benefits; and
§ Employment taxation.
Because many health care organizations are non-profit tax-exempt entities, we have a special focus on helping them to qualify and maintain their exempt status in the context of:
§ Unrelated business income taxation;
§ Joint ventures;
§ Physician recruitment;
§ Subsidiary relationships;
§ Charitable gift planning; and
§ Endowment fund development and administration.
And for health care provider organizations and providers of all kinds, we provide effective representation in audits, examinations and enforcement proceedings conducted by the Internal Revenue Service, state and local tax administrative agencies, and other tax authorities.
Technology and Licensing
We represent healthcare organizations in negotiating contracts for the acquisition of specialized medical technology through licensing agreements, joint ventures, consulting and research agreements. We structure and negotiate the terms for maximum advantage to our client, and advise on the most effective ways to manage and commercialize the technology, often in the context of auditing and developing technology management policies and programs. In addition to medical technology licensing, we also help healthcare organizations negotiate contracts for the purchase or lease of sophisticated computer, diagnostic and telecommunications hardware and software.
Other Healthcare Areas
Manatt’s multidisciplinary national practice gives our healthcare clients access to focused legal counsel on any other concerns that arise in the course of daily operations. Examples of areas in which our healthcare attorneys work with colleagues throughout the firm include:
§ Employment and benefits issues, such as compensation of physicians and executives, regulatory compliance (ADA, OSHA, ERISA);
§ Environmental concerns, particularly regarding hazardous medical waste and needle safety;
§ FDA regulation of pharmaceuticals and medical devices;
§ Insurance matters involving coverage and subrogation, directors and officers liability, risk management and third party payor contracting;
§ Patient rights concerns focusing on bioethics, confidentiality of medical records, government access to books and records, AIDS treatment counseling, controlled substances, informed consent and rights to emergency medical treatment; and
§ Rate review and rate setting.
|
RSS | Blog | Advertising Opportunities | Site Map | Contact Us