Industries: Healthcare

Latest News:

McGuireWoods Attorneys Published in Health Care Law Monthly (3/16/2010)

Illinois Nursing Home Safety Task Force Final Report: A Call for Reform (3/9/2010)

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Today’s healthcare, pharmaceutical, life sciences and medical device firms face a daunting array of legal and business issues, many of which exist in no other sector of the global economy. Among these unique challenges are regulatory compliance, credentialing, fraud and abuse prevention, product liability and payment issues.

To help our clients in these sectors find successful resolutions to these challenges—as well as to the other legal issues that they face along with the rest of American and global business—McGuireWoods offers an experienced team of more than 50 lawyers well versed in serving the needs of the healthcare, pharmaceutical, life sciences and medical device sectors. Supporting this dedicated team, McGuireWoods offers the full resources and experience of the firm’s 900 lawyers and McGuireWoods Consulting.

Healthcare

Our healthcare clients include:

• Academic medical centers
• Ambulatory Surgery Centers (ASCs)
• Assisted living facilities, care residences, continuing care retirement communities (CCRCs) and long-term care facilities
• Dialysis Facilities
• Emergency medical services agencies
• Faculty Practice Plans
• Freestanding diagnostic facilities
• Health insurers
• Health maintenance organizations (HMOs), preferred provider organizations (PPOs), management service organizations (MSOs), independent practice associations (IPAs), physician-hospital organizations (PHOs), and all other forms of managed or integrated care
• Hospices
• Hospitals & hospital systems, including community, regional, and specialty hospitals
• Individual and multi-office/multi-service medical practices
• Medical staffs
• Medical Societies and healthcare associations
• Nursing homes
• Medical laboratories
• Multi-specialty clinics
• Pharmacies
• Physicians
• Specialty medical clinics
• Venture capital companies, banks and investment banking firms

The healthcare team approaches issues from an interdisciplinary perspective, drawing on expertise from all areas of the firm, we typically use the following categories to distinguish our various healthcare services:

• Regulatory
• Financial Services
• Litigation
• Corporate Services
• Technology
• Labor

Pharmaceuticals, Life Sciences and Medical Devices

Dedicated to providing legal services to clients in the pharmaceutical life sciences and medical device industries, McGuireWoods’ Pharmaceuticals, Life Sciences and Medical Device Team represents manufacturers and sellers of drugs, biologicals, and medical devices regulated by the Food and Drug Administration.

Our team has experience counseling clients in virtually every area of sector activity, including regulatory compliance, governmental investigations and defense, product liability defense, intellectual property, labor and employment, strategic alliances and business transactions, and financing. Our expertise in the many areas of law impacting the sector enables us to provide prompt, effective counsel in response to changes in the dynamic sector.

Our clients are confronted with an intricate maze of federal regulations governing the design, testing, manufacture, sale and promotion of drugs, biologicals and medical devices. The changing nature of the industry creates business opportunity, but also creates challenges, new business models, new regulations and increasing regulatory scrutiny. The industry’s promotion of prescription drugs and devices to the medical community also raises unique regulatory and litigation issues.

Our team provides the following services:

Compliance: Our compliance team has extensive experience counseling clients on sector specific regulation, including:

• False Claims Act
• Food and Drug Administration regulations
• Federal and state anti-kickback and fraud and abuse laws
• Federal and state self-referral laws, including the federal Stark law
• Federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA)

We advise management regarding the establishment of compliance programs, with an emphasis on the Compliance Guidance for Pharmaceutical and Medical Device Manufactures, Department of Justice Guidelines for Prosecutions and the Federal Sentencing Guidelines.

Our compliance team also assists clients in:

• Enterprise-Wide Risk Management Solutions
• Assessing Internal Regulatory Compliance
• Pharmaceutical Pricing Compliance
• Sales and Marketing Compliance
• Pharmacy Benefit Management Relationship Compliance
• Clinical Trials Review and Human Subjects Protection

Strategic Alliances and Business Transactions: Our strategic alliances group provides comprehensive business advice to the sector. Our emphasis is on providing services to enable companies in the sector to achieve their business objectives. As a result of the Medicare Prescription Drug Act, new business models will be created and our group helps create, evaluate, negotiate, and implement a variety of new models.

The Medicare Act creates new administrative and management requirements for manufacturers and suppliers in dealing with the newly created prescription drug plans (PDPs). Our strategic alliance group also develops policies and procedures, creates new structures, prepares contractual relationships, and develops compliance plans for PDP relationships.

Our Pharmaceuticals, Life Sciences, and Medical Device Team also provides the following additional services:

• Products Liability
• Government Investigations
• Intellectual Property