Health Care - Government Contracts
McKenna Long & Aldridge (MLA) attorneys and policy advisors are leaders in health care law, who operate at the intersection of health care and government, providing counsel to their clients. MLA attorneys handle a broad spectrum of health care matters, ranging from the completion of basic transactions, to the guidance and support necessary to successfully maneuver the more intricate and complex situations that often arise in the health care industry. The services offered by MLA's Health Care team clearly demonstrate the versatility of its members, through skillfully confronting matters, whether transactional, regulatory, or litigation-specific. The industry's legal landscape is constantly shifting, as new laws are drafted in Congress and policies are implemented at a federal and state level in the U.S. In 2008 and 2009, MLA’s Health Care group was recognized by Chambers USA as one of the best practices in Georgia.
MLA handles every aspect of health care advocacy, cutting across practice areas and pooling the firm’s resources to present comprehensive support to our clients. From regulatory affairs to litigation to public-private partnerships, this team provides clients with premier service when it comes to criminal and civil fraud defense of pharmaceutical and medical device companies, as well as defense of alleged violations of the U.S. Food, Drug, and Cosmetics Act, anti-kickback, off-label marketing, and fraudulent pricing matters.
Our team blends together legal experience with industry knowledge, and includes professionals with PhDs in chemistry and mechanical engineering. Our team includes a former attorney with the Food and Drug Administration, and other professionals with backgrounds in government affairs, and agencies, as well federal, state and local regulatory agencies. Our team grasps the complex legal and regulatory obstacles confronting health care organizations today, especially in the current political climate that is calling for health care reform.
Some of our relevant experience:
- Succeeded in securing interim Patient Safety Organization (PSO) certifications from the U.S. Department of Health and Human Services, for Northern Metropolitan Patient Safety Institute and the Alliance for Patient Medication Safety;
- Represented Sanofi Pasteur in successfully persuading the Centers for Medicare and Medicaid Services (CMS) to declare three outpatient drugs to be outside of coverage under the Medicaid drug rebate program;
- Successfully defended four hospital systems against separate class actions brought on by uninsured plaintiffs challenging non-profit hospitals’ charges;
- Defended major managed care insurer inRICO on fraud, extortion and related claims in In Re: Managed Care MDL class action litigation; prevailed on summary judgment after multiple appeals;
- Regularly counsel acquisitions and divestitures of hospitals in, and around Georgia;
- Managed and guided reorganization of a large academic medical center;
- Provide general representation of physicians and physician groups, including such matters as executive compensation;
- Regularly defend medical device manufacturers and individuals accused of criminal FDA violations; including successful representation of approximately 30 employees in a criminal investigation of off label marketing and other alleged violations of the Food Drug and Cosmetic Act (FD&CA); None of our clients were prosecuted; and
- Representing pharmaceutical manufacturers, physicians and corporate health care providers accused of kickbacks and fraudulent Medicare/Medicaid billing.
Our team has recently addressed cutting-edge topics involving:
- Stark and anti-kickback laws
- Government and legislative affairs
- Physician contracting
- Governmental investigations, including qui tam proceedings
- Mergers and acquisitions
- Medical staff peer reviews
- Privatization of health care facilities
- Medicare, Medicaid and managed care issues
- Not-for-profit hospitals
- FD&CA violations
When health care clients turn to MLA for help, they can trust that their matter is handled sensitively, professionally and responsibly by a team with the knowledge and passion to succeed.
Advisories
- December 21, 2012
- December 14, 2012
- November 30, 2012