McDermott Will & Schulte, a global law firm

James A. Cannatti III advises healthcare, technology, and life sciences organizations on complex regulatory, compliance, and enforcement matters at the forefront of the evolving healthcare ecosystem. His practice spans digital health and health information technology (IT) policy, fraud and abuse compliance, and emerging regulatory risk areas, including in the diagnostics, life sciences services, research, pharmacy, and distribution space.

James counsels healthcare providers, diagnostics companies, health IT developers, and life sciences services and research companies on compliance with federal healthcare requirements, including the Anti-Kickback Statute, Stark Law, and EKRA. He also represents clients in internal investigations and enforcement matters, drawing on his deep experience with government expectations and enforcement priorities to provide practical, regulator-informed guidance on navigating enforcement risk and regulatory change.

James’s advisory work frequently addresses cutting-edge regulatory topics and developments, including:

• Fraud and abuse risk and enforcement trends involving healthcare providers, diagnostics, laboratory services, and life sciences companies
• Internal investigations and responses to government inquiries involving the US Department of Justice and the US Department of Health and Human Services’ Office of Inspector General (OIG)
• Compliance with the Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act of 2018 in complex commercial arrangements
• Digital health enforcement and compliance risks, including remote patient monitoring and telehealth
• Information blocking and interoperability requirements under the 21st Century Cures Act
• Health IT certification, APIs, and data-sharing obligations

Before entering private practice, James spent more than a decade at the OIG, where he held a range of roles, including serving as its first Senior Counselor for Health Information Technology. In that role, he worked on the development, interpretation, and enforcement of federal healthcare policy affecting providers, health IT developers, and other industry stakeholders.

While in law school, James served as a managing editor of the Ohio State Journal on Dispute Resolution.

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.

Jon Dubrow is the US head of McDermott’s Antitrust Group. For over three decades, Jon has served as a strategic advisor to clients across a host of interrelated antitrust issues, including mergers and acquisitions (M&A), counseling, and litigation. He leads the defense of mergers, acquisitions and joint ventures before the Department of Justice, the Federal Trade Commission and other international competition authorities. Jon also regularly assists customers, suppliers, and competitors whose interests are adversely affected by proposed transactions. Jon also is experienced in antitrust litigation. He provides counseling on distribution issues, contracting arrangements and a wide variety of other competition-related matters.

Jon obtains clearance in the initial review period even for transactions raising significant substantive issues, avoiding the time and cost of a second request. He takes a very proactive approach in managing the regulatory review process designed to minimize the potential need for an in depth government investigation. He has filed and managed the preparation of hundreds of Hart-Scott-Rodino (HSR) premerger notification forms and regularly provides HSR counseling. He has also managed multinational merger filings in numerous transactions. Jon frequently teams with regional corporate law firms (in Rochester, Pittsburgh, Cleveland, Louisville, New Orleans, and others), allowing them to offer sophisticated and seamless antitrust M&A services to their clients when they do not have internal capability, or they need to supplement their teams for more complex matters.

Jon counsels clients on a broad range of antitrust issues, including information exchanges, teaming agreements, joint venture ancillary restraints and distribution practices such as pricing restraints, bundled discounting, price discrimination, exclusive distribution, dealer termination and exclusive dealing.

Jon has defended a wide variety of antitrust claims in litigation, including Sherman Act monopolization and conspiracy claims involving alleged price fixing, market allocation, tying, "bundled discounts," "aftermarket" parts and services, theft of trade secrets, defamation, other business torts and other alleged anticompetitive conduct. He also defends governmental challenges to acquisitions under Section 7 of the Clayton Act.

Jon has handled antitrust issues in scores of different industries. He has a particularly strong background in several industry-based representations covering multiple matters, including aerospace and defense, pharmaceuticals / biologic products, medical devices, construction products, and consumer products such as beer, wine, beverage alcohol and cannabis.

Jon is known for his meticulous attention to detail and his ability to navigate complex regulatory landscapes effectively. As one client quoted in Chambers and Partners, "Jon is proactive and pays careful attention to every detail. He learns the business of his clients as if it were his own business and uses that information to provide clear strategy and advice." Another client highlighted his understanding of their industries, stating, "Jon understands the client's businesses and the industry in which the client engages. He has a deep understanding of the positions being taken by all of the relevant government agencies."

Daniel F. Gottlieb counsels a wide range of healthcare industry clients, including healthcare providers, health plans, health information technology vendors, life sciences companies and data aggregators. He is sought out for his legal knowledge and practical approach on data protection, interoperability, and complex data and software licensing transactions, collaborations and strategic initiatives.

Daniel counsels healthcare clients regarding compliance with US federal and state and international privacy, security, breach notification and information blocking laws, including the Health Insurance Portability and Accountability Act (HIPAA), 21st Century Cures Act, California Consumer Privacy Act (CCPA), Telephone Consumer Protection Act, CAN-SPAM and EU General Data Protection Regulation (GDPR). He offers guidance on the intersection of privacy and security requirements with information blocking prohibitions under the 21st Century Cures Act and Medicare rules impacting the deployment of health information technology.

Daniel has deep experience regarding requirements for de-identification, anonymization and other secondary uses of health information under HIPAA, CCPA and GDPR. Daniel regularly advises clients regarding their response to cyberattacks and other security breaches, and defends against subsequent investigations by state regulators and the US Department of Health and Human Services Office for Civil Rights.

He advises healthcare clients on all aspects of data and software licenses and other agreements for the acquisition of electronic health record (EHR) systems and other mission-critical health IT and health content. He drafts and negotiates hosting, cloud computing and IT service agreements, as well as license agreements for health data and other health content.

Daniel assists with compliance program implementations, compliance audits, and government program overpayment and refund matters, including drafting billing compliance policies and procedures. He also counsels clients on compliance with Medicare and Medicaid reimbursement, fraud and abuse laws; the PhRMA Code on Interactions with Health Care Professionals; and the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

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.

Advises clients on telehealth, remote patient monitoring, AI-enabled tools, consumer wellness and other virtual care or digital health companies on product development, compliance, commercialization, and reimbursement strategies

Guides clients on structuring compliant care delivery models, navigating multi-state licensure, and advising on fraud and abuse, data privacy, cybersecurity, and other key areas

Advises mail order, retail and other types of pharmacies, suppliers and manufacturers on partnerships with healthcare companies and related compliance considerations

Develops compliance frameworks for consumer wellness programs and mobile health solutions

Leads retailers, tech companies and other non-healthcare companies through their development and launch of healthcare products or offerings

Structures provider networks and strategic collaborations among hospitals, health centers, and physicians

Counsels investors on healthcare trends, reimbursement opportunities and changes in laws to assist with designing their investment strategies

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.

David P. Saunders (CIPP/US, CIPM) is an experienced litigator who focuses his practice on privacy and cybersecurity matters. David helps clients through the life cycle of their data privacy needs. He helps them mitigate and manage risks related to data privacy and cybersecurity by assisting their government affairs teams with the development of new privacy legislation, their legal and compliance teams through the implementation of privacy programs, and their litigation teams through regulatory investigations and civil class action litigations.

David has represented dozens of companies across industries in connection with civil litigation and pre-suit demands related to a wide-array of privacy-related litigation. Whether related to website tracking technologies, fallout from a data breach, biometric data collection, or claims of unfair and deceptive trade practices, David has experience successfully resolving litigation matters for clients.

David has worked with a number of state attorney general’s offices and federal regulators, and advocated on behalf of clients in the AdTech, telecommunications, healthcare, and financial services sectors in response to routine inquiries as well as civil investigations. His work also includes collaborating with clients to provide testimony and comment on existing and planned data privacy legislation and regulation at the state and federal levels.

David has experience in all aspects of privacy program implementation, from conducting risk assessments and drafting privacy policies to planning around cross-border data transfers and negotiating vendor agreements. He regularly counsels on GDPR, GLBA, CCPA, CAN-SPAM, and the growing list of state privacy laws and regulations. David also regularly performs due diligence for corporate transactions.

David maintains an active pro bono practice, having represented inmates in various actions in state and federal courts, and providing privacy program development, counseling, and training to nonprofits.

Steven J. Schnelle is a trusted advisor to investors, executives, general counsel, and business operators in the healthcare and life sciences sectors, delivering actionable strategies to help them achieve market leadership, drive transformative growth, and navigate complex regulatory landscapes. With a national reputation for his transactional acumen and regulatory insights, Steven brings clarity and alignment to multifaceted arrangements, empowering organizations to excel in today’s dynamic healthcare environment.

Steven is a recognized authority in national reimbursement strategy, enabling clients to maximize the value of healthcare services and products. His counsel is particularly sought after by executive leadership teams and general counsel in hospital systems, as well as by professional groups; pharmacy service providers; clinical laboratories; and manufacturers of pharmaceuticals, medical devices, and durable medical equipment. He has extensive experience in advising on cutting-edge regulatory developments and innovative business models, ensuring his clients remain competitive and compliant.

Core Areas of Experience:

• Healthcare Mergers and Acquisitions (M&A). Guiding transactions involving changes of ownership and control with a focus on seamless regulatory coordination
• Federal Healthcare Oversight. Managing audits, investigations, and compliance with federal programs
• Third-Party Payer and Reimbursement. Addressing challenges and opportunities in payer participation and payment structures
• Medicare Administrative Appeals. Driving favorable outcomes in high-stakes appeals
• Sector-Specific Regulations. Navigating the nuanced regulatory requirements of health facilities, corporate practice, pharmacy, clinical laboratories, hospice care, and pharmaceutical/device manufacturing
• Pharmacy Matters. Counseling pharmacies on state and federal regulatory frameworks, Medicare enrollment disputes, and revocations

Steven has also cultivated a niche practice in navigating the complexities of the 340B Drug Pricing Program, providing tailored guidance on program development, audit response, manufacturer repayments, and litigation. His ability to resolve intricate issues relating to duplicate discounts and alleged diversion has earned him accolades from healthcare providers and pharmacy services providers alike.

Thought Leadership

Steven’s thought leadership has been widely recognized, with accolades from Chambers USA and other prestigious legal directories. He is a sought-after speaker at industry conferences, addressing topics ranging from healthcare M&A trends to reimbursement innovation. His insights have also been featured in leading publications, and he frequently mentors the next generation of legal talent in the healthcare sector.

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.

Kristian (Krist) Werling is the global head of McDermott’s Health & Life Sciences practice, which provides regulatory and transactional counsel to health and life sciences industry leaders, changemakers, and investors.

Krist and the McDermott Health & Life Sciences team lead the most significant transactions, critical regulatory issues, and litigation matters that shape the health and life sciences industry. In his own practice, Krist represents life sciences companies, health service providers, private equity firms, and venture capital investors in a wide variety of transactional and regulatory matters. He has led cutting-edge industry transactions that have introduced cancer and gene therapy products to the global market, expanded access to fertility services, increased the availability of cost-effective outpatient surgical services, and transformed the delivery of physician services in a broad range of specialties.

Krist's decades of experience on the buy-side and sell-side of health and life sciences dealmaking spans the healthcare and life sciences landscape. He leads cross-disciplinary teams and delivers business-focused legal guidance to help clients pursue their most innovative strategies, working across borders and health and life sciences subsectors to connect and advise industry stakeholders. Krist is also skilled at developing creative transaction structures, conducting sector-specific due diligence, and providing forward-looking counsel to mitigate issues that can derail transactions or stunt long-term growth. His deep understanding of sector-specific regulatory nuances allows him to efficiently close transactions and maximize client outcomes.

Representative PE clients include Ampersand Capital Partners (buy-side and sell-side); Amulet Capital Partners (buy-side and sell-side); Windrose Health Investors (buy-side and sell-side M&A, and joint venture matters); Iron Path Capital (investments, carve-out acquisitions and new platform formations), Quad-C (new platform formation and investment and sell-side), PPC (buy-side).

Representative healthcare and life sciences companies include Baxter International and Vanda Pharmaceuticals (cross-border sales and acquisitions; licensing); REGENXBIO (strategic partnership with AbbVie); Cleveland Clinic, Hospital for Special Surgery and Northwestern Medicine (strategic innovation investments and joint ventures); numerous founder-owned businesses in strategic transactions with investors.

Stephen Wu is a nationally recognized antitrust lawyer with more than twenty-five years’ experience defending clients against antitrust litigation and government investigations into mergers and acquisitions and business practices. Stephen is also a trusted strategic advisor who counsels clients on antitrust compliance issues.

Stephen has successfully defended clients in class actions and other complex litigation brought by purchasers, competitors, and employees alleging unlawful price-fixing, wage-fixing, exclusive dealing, group boycott, market allocation, tying, and monopolization claims in federal courts around the country. In addition, Stephen has successfully defended numerous mergers and acquisitions and clients’ business practices from Federal Trade Commission (FTC), Department of Justice, and State Attorneys General investigations. He also regularly advises clients on pricing, distribution, and joint venture matters.

Stephen represents clients in a wide variety of industries, ranging from consumer goods to healthcare to packaging. He is co-head of the Firm’s Health Antitrust Practice Group.

Stephen has been recognized as a leading antitrust lawyer by The Best Lawyers in America, BTI Consulting, Chambers USA, Global Competition Review, Lawyers of Color, The Legal 500 USA, LMG Life Sciences, The National Law Journal, Super Lawyers, and Thomson Reuters Stand-Out Lawyers.

Prior to joining the Firm, Stephen was an attorney for the FTC, where he received its Award for Meritorious Service. At the Firm, Stephen received McDermott’s Pro Bono and Community Service Award for his pro bono efforts.

Sam Siegfried is a trusted advisor on emerging healthcare technology matters, with a particular focus on data privacy and security, artificial intelligence (AI), clinical research, and complex technology transactions. He helps healthcare and life sciences companies navigate evolving regulations, maximize data-driven opportunities, and implement innovative technologies. He also conducts privacy and research diligence and negotiates transition services agreements for mergers and acquisitions, strategic investments, and joint ventures.

With extensive experience in key privacy frameworks, including the Health Insurance Portability and Accountability Act (HIPAA), the California Consumer Privacy Act (CCPA), Washington’s My Health My Data Act (MHMDA), the General Data Protection Regulation (GDPR), and other evolving US and global data protection frameworks, Sam provides critical data strategy guidance to digital health platforms, genomic sequencing providers, health systems, biotech firms, and other health and life sciences organizations.

As AI reshapes healthcare delivery and innovation, Sam works closely with AI developers and deployers on AI governance programs, generative AI use, and consumer protection risks. In the clinical research space, he advises on federal and state research regulations, research compliance program development, research informed consent, and Institutional Review Board (IRB) requirements.

Beyond his regulatory practice, Sam structures and negotiates complex commercial transactions, including data licensing agreements, software as a service (SaaS) and other technology platform agreements, AI development partnerships, research collaborations, and clinical trial agreements.

Before joining McDermott, Sam served as in-house counsel at an academic medical center and a precision medicine startup, handling complex privacy, research, and healthcare regulatory challenges. This frontline experience informs his pragmatic approach, allowing him to deliver solutions that seamlessly integrate compliance with business objectives.