McDermott Will & Schulte, a global law firm

Stacey Callaghan counsels digital health organizations, healthcare entities, and private equity clients as they navigate regulatory, compliance, and transactional issues. She focuses on assisting clients in developing telemedicine strategies and documenting multi-state telehealth arrangements given the evolving digital health regulatory landscape. As co-head of our Women’s Digital Health Initiative, Stacey focuses on aiding digital health providers of women’s health services navigate issues unique to the industry and works to help these clients successfully advance their efforts. Stacey also assists clients in matters including data privacy and protection requirements under HIPAA and other privacy laws, data breach investigations and compliance, and data sharing, licensing, and de-identification arrangements.

Stacey is experienced in executing healthcare transactions, and routinely guides clients through joint ventures, mergers and acquisitions and strategic collaborations. She counsels on governance matters and regulatory issues, including compliance with federal and state fraud and abuse laws.

Prior to joining the firm, Stacey was a healthcare associate at a large US-based law firm. She is a frequent author on a variety of healthcare legal issues, primarily those issues impacting providers in the digital health space. During law school, Stacey served as the executive notes editor for the Journal of Legislation.

David Quinn (Dave) Gacioch focuses his practice on litigation and enforcement defense, primarily related to the US healthcare sector.  Dave counsels hospitals, health systems, physician practices, and other providers, along with payors, private equity sponsors, pharmaceutical and medical device manufacturers, and others involved in the US healthcare system, on compliance and risk mitigation issues.  He conducts internal investigations for clients, and represents them in government investigations, enforcement actions, and civil and criminal litigation, including class actions.

Dave has deep experience across a number of key substantive issues, including:

• False Claims Act matters pursued by whistleblowers (qui tam cases) or government authorities;
• Fraud and abuse issues arising under the Anti-Kickback Statute, the Stark Law, and other laws governing federal healthcare programs such as Medicare and Medicaid—especially fair market value (business valuation and professional services compensation) issues;
• Federal and state oversight of controlled substance laws, including defending Drug Enforcement Administration (DEA) investigations;
• Information privacy, cybersecurity and data breach response issues arising under the Health Insurance Portability and Accountability Act (HIPAA), 42 C.F.R. Part 2, and other US federal and state laws;
• Website and mobile application user tracking technologies and potential regulatory and litigation challenges to their deployment, including under wiretapping/eavesdropping statutes;
• Conscience and religious freedom-based investigations of providers by the US Department of Health & Human Services, Office for Civil Rights (HHS-OCR);
• Negotiation of, and compliance with, corporate integrity agreements (CIAs) and corrective action plans (CAPs);
• Response to sentinel events, such as allegations of provider staff abuse of patients— including compliance with real-time administrative and criminal reporting obligations while planning for potential investigative, civil litigation, and community relations impacts downstream;
• Compliance with and investigation preparation/defense regarding COVID-19 pandemic relief programs such as the CARES Act Provider Relief Fund and advance/accelerated Medicare payments; and
• Response to civil investigative demands (CIDs) and subpoenas.

Dave works closely with McDermott’s best-in-class Health Industry Advisory team to provide litigation and enforcement defense representation informed by leading-edge thinking on complex healthcare regulatory issues.  As a recent example, Dave co-leads the Firm's Post-Dobbs Resource Center - a joint healthcare, regulatory, privacy and litigation team that counsels clients on how to navigate the challenging legal landscape around abortion and other reproductive health care in the wake of the US Supreme Court's  Dobbs v. Jackson Women’s Health Org. decision in 2022.

Additionally, Dave is working closely with McDermott’s best-in-class Health Information Privacy and Privacy/Cybersecurity teams to provide comprehensive, strategic counseling and representation to clients around website and mobile application user tracking and marketing technologies (AdTech)—including defending multiple class action cases brought against clients under wiretapping/eavesdropping statutes.

Dave is one of the leading lawyers in the United States in the area of responding to HHS-OCR investigations, whether based upon HIPAA or upon conscience and religious freedom laws, and negotiating favorable resolutions when such investigations result in allegations of non-compliance by covered entities or business associates. Notably, Dave served as lead counsel in the successful defense of a health system against the first attempt by the HHS-OCR and the Department of Justice Civil Rights Division to take conscience-based enforcement action against a provider—securing a dismissal of the DOJ lawsuit and a reversal of HHS-OCR’s notice of violation.

As a former advanced emergency medical technician and ambulance service officer, Dave brings a provider’s perspective to the practicalities of healthcare compliance and risk mitigation, which allows him to grasp issues quickly and to communicate them effectively both to and on behalf of providers.

Dave’s practice also includes commercial litigation and dispute resolution on behalf of a variety of clients inside and beyond health care, including a leading alcohol beverages brand.  Additionally, Dave serves as national coordinating counsel for a building products manufacturer in the asbestos product liability litigation.

Dave regularly writes and lectures on the issues referenced above. Dave also has significant trial, hearing, and arbitration experience, and has performed extensive pro bono work.

Previously, Dave served as law clerk to the Honorable Ernest C. Torres, Chief Judge of the US District Court for the District of Rhode Island.

Caroline Reignley provides strategic legal, regulatory and compliance counsel to for-profit and nonprofit hospitals, health systems, other healthcare providers, life sciences and technology companies.

Fraud and Abuse

Caroline counsels clients on interpretation and risk mitigation under the Anti-Kickback Statute, Stark Law and EKRA. She also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statute. Her extensive experience navigating civil and criminal investigations within the healthcare space informs her strategic approach to risk management in transactions and the development of robust compliance programs.

Digital Health

Caroline advises clients involved in digital health—the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the internet and mobile devices—on the applicable legal and regulatory infrastructure, with a particular focus on remote patient monitoring programs. She offers nuanced insights into fraud and abuse issues that arise in novel partnerships and other relationships between digital health companies and established healthcare providers. Her broad experience allows her to deliver practical, forward-thinking compliance and revenue strategies that help her clients thrive in today’s complex and still-evolving digital health regulatory landscape.

Medicare Reimbursement and Healthcare Compliance Matters

Caroline advises Medicare providers, consultants and vendors on a wide range of business, legal and regulatory issues. Caroline has extensive experience advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding. She also advises clients on professional licensure, scope of practice, physician and health care professional clinician relationships and supervision, together with overall corporate compliance.

Prior to joining the Firm, Caroline served as a health law fellow for a regional nonprofit health system and as a law clerk at the US Department of Health and Human Services. Her background gives her a deep understanding of legal issues from both the regulator and provider perspectives.

Sarah G. Raaii devotes her practice to issues impacting group health and welfare benefit plans by counseling employers, digital health and point solution clients, plan administrators, insurers, consultants and other health plan service providers.

Sarah advises her clients on healthcare reform issues; consumer-driven health benefits; self-funded and fully insured health plans; data privacy and the Health Insurance Portability and Accountability Act (HIPAA); wellness programs; cafeteria plans; and regulatory, sub-regulatory and legal compliance. She provides guidance on the Affordable Care Act (ACA); the Employee Retirement Income Security Act (ERISA); health plan transparency; mental health parity; the No Surprises Act; the Consolidated Omnibus Budget Reconciliation Act (COBRA); flexible benefit plans; health reimbursement accounts (HRAs); health savings accounts (HSAs); plan network design; multiple employer welfare arrangements (MEWAs); association health plans; captive insurance arrangements; and other health benefits issues.

Sarah drafts and negotiates complex agreements between employers, health plans, third-party administrators, pharmacy benefit managers, carriers, consultants and other health plan service providers. She also counsels digital health, telehealth and point solution entities; third-party administrators; pharmacy benefit managers; and other benefit administrators on partnering with employers, group health plans and insurers. As co-chair of the Firm’s Post-Roe Working Group – a multidisciplinary team of lawyers providing clients with reproductive health guidance – Sarah has advised hundreds of health plans and benefit administrators on health benefits following the end of Roe v. Wade.

Additionally, Sarah routinely analyzes frequently changing health benefits laws and regulations and recommends risk mitigation strategies. She provides strategic due diligence and health benefits design, implementation and transition advice on issues arising from corporate and private equity mergers, acquisitions and other transactions.

Sarah frequently publishes and presents on health benefits trends and developments and has been quoted on health plan issues in prominent media outlets, including The New York Times, The Wall Street Journal, Bloomberg Law and Law360.

Prior to joining the firm, Sarah worked at the White House for the National Economic Council, where she implemented the ACA with leaders from the Executive Office of the President, the US Department of Labor, the US Department of Health and Human Services, and the US Department of the Treasury. She previously collaborated with in-house lawyers and federal and state government relations professionals in the leadership development program of a Fortune 500 global insurance and financial services corporation.