McDermott Will & Schulte, a global law firm

Emily Jane Cook serves as counsel to clients in the healthcare sector from start-ups to established market leaders on a wide range of critical regulatory matters to ensure compliant business operations. Her guidance allows these organizations to prospectively and retrospectively manage the risks associated with operating in a high-complexity and highly-regulated sector.

A national authority on the 340B drug pricing program, Emily also helps clients across the country navigate a wide range of complex federal and state healthcare regulations. Her counsel encompasses issues such as navigating federal and state fraud and abuse laws, development of innovative models for healthcare delivery, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, and federally qualified health centers. This depth of knowledge across many regulatory issues allows her to provide her clients with comprehensive legal advice and guidance, which allows them to fully evaluate risks in their business and clinical operations. She works closely with colleagues in McDermott’s diverse practice areas to deliver fully realized solutions for her clients.

Emily’s deep insights into US healthcare regulation stem from her previous tenure at the US Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). For more than five years, she worked with providers and across government agencies to address regulatory barriers to healthcare delivery. She advised senior HHS leadership on Medicare and Medicaid regulation and reimbursement issues affecting rural communities and providers, and served as senior policy advisor to the National Advisory Committee on Rural Health and Human Services.

Emily is an active member of the American Health Law Association, where she most recently served as the Chair of their Medicare and Medicaid Institute. She is also a member of the firm’s Health/White Collar cross-practice group.

Matt Knowles advises companies, boards of directors and individuals in high-stakes commercial litigation as well as government and internal investigations. His work spans a broad range of litigation matters at the trial and appellate levels in federal and state courts across the country, including class actions and other complex matters. Matt also represents clients in investigations conducted by federal government agencies as well as state attorneys general.

Matt frequently represents companies and individuals in investigations and litigation under the False Claims Act. He also has substantial experience helping clients manage legal and reputational risk in crisis situations, including recent matters involving disease outbreaks at hospitals, allegations of misconduct at medical facilities and disputes involving educational institutions.

Matt has an active pro bono practice, where he has challenged wrongful convictions, a death penalty appeal, disputes between students and educational institutions concerning reasonable accommodation and racial discrimination, domestic violence victim protection cases and employment discrimination matters.  He recently represented a traveler in pro bono litigation against TSA after an abusive search and false arrest at an airport checkpoint. This case resulted in an en banc decision from the Third Circuit establishing travelers’ rights to pursue damages from the TSA under the Federal Tort Claims Act.

Matt graduated cum laude from Harvard Law School, where he was the recipient of the Charles H. Smith Bequest Scholarship and was named a Dean’s Scholar in the Federal Courts and the Federal System. He served as an honors legal intern in the Office of Legal Counsel for the US Department of Defense and as an intern in the office of the US Attorney for the District of Massachusetts. He also served as an intern to the Chief Justice of the Rhode Island Supreme Court.

Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. Tony is a practice area leader for the Healthcare Regulatory & Compliance practice.

He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Tony also draws on his background in government investigations to assist clients in evaluating, developing and implementing corporate compliance programs.

Tony previously served as deputy chief of the Administrative and Civil Remedies Branch of the US Department of Health and Human Services (HHS) Office of Inspector General (OIG), where he represented the agency on investigating FCA and civil monetary penalty cases, negotiating and monitoring corporate integrity agreements, and defending exclusion appeals. While serving at HHS, Tony was a principal author of the OIG's current Self-Disclosure Protocol. He also has advised CMS on policy issues, including the Medicare Overpayment Rule and the creation of the Self-Referral Disclosure Protocol.

Tony represents a wide variety of clients, including

• Hospitals and health systems
• Professional services organizations and physician practice management companies, such as anesthesia, dentistry, dermatology, emergency medicine, oncology, primary care, radiology and wellness practices
• Pharmaceutical and medical device manufacturers and distributors
• Long-term care, home health, hospice and other post/sub-acute providers
• Pharmacies and pharmacy benefit managers
• Dialysis providers
• Laboratories
• Ambulance companies
• Health plans
• Electronic health records and revenue cycle management vendors
• Investors and other financial institutions that invest in and/or support the health care and life science industries

Tony writes and speaks frequently on health care regulatory topics and has lectured on health care fraud and abuse issues at Boston University School of Law and American University Washington College of Law.

Prior to his government service, Tony represented hospitals and physician practices on health care regulatory and corporate compliance issues. During law school, Tony was the editor of the 2001 Symposium issues of the American Journal of Law and Medicine.

Drew Elizabeth McCormick is a seasoned healthcare regulatory lawyer whose practice spans the full spectrum of federal and state regulatory oversight of the health industry. She is particularly known for her sophisticated command of fraud and abuse laws — including the Anti-Kickback Statute, the Stark Law, the False Claims Act, and state fraud and abuse analogues — as well as Medicare and Medicaid program rules, reimbursement rules and policy, and enrollment, licensing, and certification requirements. She also has extensive experience in various emerging areas of healthcare regulation, including surprise billing regulation and state transaction notice laws.

Drew regularly leverages this deep regulatory knowledge in government audits, civil investigative demands, and internal investigations, helping clients assess exposure, craft defensible responses, and navigate complex interactions with enforcement agencies. Her work also extends to the transactional arena, where she identifies regulatory risks, structures compliant arrangements, and supports diligence and post-closing integration for strategic transactions.

In addition, Drew provides strategic, day-to-day counseling to healthcare providers, payors, and emerging companies, guiding them through operational questions, policy changes, and compliance program design to support both business objectives and regulatory integrity.

Mara Theophila regularly defends healthcare and life sciences clients across the country in high-stakes government investigations and complex commercial litigation. Her clients include pharmaceutical companies, medical device manufacturers, hospitals, ambulatory surgery centers, healthcare networks, physician practices, individual providers, laboratory diagnostic testing companies, insurance brokers, healthcare software companies, and private equity firms.

Mara’s practice focuses on the intersection of government oversight in the healthcare and life sciences space. She has substantial experience with the False Claims Act (FCA), the Food, Drug, and Cosmetic Act (FDCA), the Anti-Kickback Statute (AKS), the Stark Law, and related state laws. Mara has a proven track record of obtaining favorable results for clients in defending against claims being investigated or pursued by the US Department of Justice (DOJ), state attorneys generals, and private litigants. Additionally, Mara works closely with clients to manage their potential FCA and regulatory risks by developing compliance initiatives and other internal measures to minimize exposure moving forward.

Mara also maintains an active pro bono practice, including representation of indigent criminal defendants, non-profit organizations and visa and asylum applicants.

Mara previously served as a law clerk for the Honorable Judge Jane R. Roth of the US Court of Appeals for the Third Circuit and for the Honorable Paul A. Crotty of the US District Court for the Southern District of New York.

Jennifer (Jenn) Routh is a trial lawyer who leads high-stakes, complex civil litigation, including matters involving billions of dollars of exposure. She has secured numerous jury verdicts and bench trial wins across a range of disputes, including trade secrets, breach of contract, fraud, breach of fiduciary duty, products liability, negligence, and unfair competition. She won the first jury verdict obtained by any litigant under the Defend Trade Secrets Act, the federal trade secret statute. She is the Partner in Charge of the firm’s Washington, DC, litigation practice.

Jenn represents clients in state and federal courts nationwide, with a particular focus on False Claims Act litigation. Her practice includes qui tam and enforcement actions, including those involving managed care (Medicare Part D and Medicare Advantage), and she represents pharmaceutical companies, payors, and providers in high-stakes healthcare disputes. She also handles disputes for private equity-backed companies, including ownership and control disputes.  Beyond the healthcare space, Jenn represents clients in high-profile, bet-the-company litigation involving novel and highly contested liability issues and significant reputational risk.

Jenn is actively engaged in pro bono representations. She previously clerked for the Honorable Thomas F. Hogan of the US District Court for the District of Columbia.

Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.