Commercial Products and Services
Compliance and Voluntary Disclosure
Foreign Sales/International Government Contracts
Government Finance & Privatization
Life Sciences and Public Health Preparedness
Military Bases and Communities
Public Health and Pharmaceutical Compliance
Radio Frequency Identification (RFID)
State and Local Government Contracts
Teaming Agreements and Subcontracts
Intellectual Property and Technology
MLA’s health care attorneys have an in-depth understanding of the increasing challenges and complex regulatory issues that can compromise the objectives of industry providers and participants upon being introduced into today’s complicated economic and political landscapes. Our team is equipped with the knowledge, experience, and insight needed to effectively help clients navigate through the obstacles resulting from regulation and change, both in the private and public sectors. Our clients have included players in all areas of the health care industry, including medical devices, technology and pharmaceutical manufacturers, hospitals, hospital authorities, pharmacies, health care suppliers, large physician group practices, as well as health care payors and third party benefits administrators. We keep up-to-date on regulatory changes and shifts in governmental oversight and enforcement priorities. The group provides regular counsel on a wide range of state and federal statutes and regulations that affect players in the health care industry. This responsibility includes advice regarding compliance with licensing, accreditation and reporting requirements; compliance with the complex environment surrounding reimbursement under federal and private health care programs; proper structure and organization under federal and state fraud and abuse laws; human subject research regulatory compliance; and compliance with the Health Insurance and Portability and Accountability Act of 1996 ("HIPAA"). The complex regulatory environment in health care further impacts the structure of transactions within the industry. Transactional services in the health care arena take many forms, including mergers, acquisitions, divestitures, spin-offs, business formations, complex joint ventures, as well as employment and independent contractor agreement. The transactional matters handled by the group require advising clients on numerous complex regulatory schemes, including tax exemption, financing, antitrust issues, reimbursement, licensure, and certificates of need. All proposed relationships and payments must be carefully examined in light of federal and state fraud and abuse laws to ensure compliance. Our group has extensive experience representing entities in the health care industry in properly structuring and implementing their transactional matters.
The government has consistently targeted the health care industry as a primary focus of fraud and abuse investigations and actions. The group has extensive experience in audits and investigations, ranging from small state investigations to large federal Department of Justice investigations of Fortune 500 companies. These investigations can arise in many different contexts and take many different paths, depending on whether the provider is the subject of an investigation or the target of an investigation. We have defended providers in governmental investigations at both the federal level (dealing with the Department of Justice, the Office of Inspector General, and the Center for Medicare and Medicaid Services) and the state level (dealing with, for example, the Georgia State Medicaid Fraud Control Unit and various state Attorneys General in Georgia and elsewhere).