Clients across the health care industry rely on Elizabeth Scarola to help them navigate the complexity of today’s regulatory environment. Elizabeth brings an insider’s perspective to her health care practice. In addition to her in-house experience in a multistate health system and her work on strategic, operational, and legal projects for a statewide clinically integrated network of hospitals and providers, she has hands-on scientific research experience. Also, Elizabeth has conducted independent research in pediatric endocrinology and contributed to such publications as the Journal of the American Medical Association and The New England Journal of Medicine. Among Elizabeth’s clients are academic medical centers, health systems, hospitals, providers, payors, clinical research sites, electronic health record companies, and other entities that support the health care industry.
Elizabeth informs her clients of regulatory trends and policy developments. She also provides advice and counsel regarding federal and state fraud and abuse laws and regulations, issues relating to the conduct of clinical research, and laws and regulations affecting telehealth and telemedicine companies. In addition, clients turn to Elizabeth to guide them through strategic affiliations and transactions drafting and negotiating various agreements.
Elizabeth is frequently asked to speak on topics in health care law. She has served as an instructor for an undergraduate course on health care policy, medical ethics, patient safety, and the Affordable Care Act at the University of Michigan, and as an adjunct professor for a graduate course on health care compliance at Stetson University College of Law. Elizabeth has also authored numerous legal publications and currently serves as a co-editor of the Florida Bar Health Law Section’s Health Law Updates.
Before joining Epstein Becker Green, Elizabeth was an attorney in the health care practice group of a national law firm. Prior to that, she served as a Legal Extern in the Offices of Corporate Counsel for a national, not-for-profit Catholic health system based in Michigan and an affiliated hospital in Indiana.
Advice and Counsel Related to Health Reform
- Provided advice and counsel to a hospital regarding considerations for potential mergers, acquisitions, and strategic affiliations to better compete following health care reform.
- Provided advice and counsel to an academic medical center regarding the formation of a clinically integrated network.
- Provided advice and counsel to a physician group regarding participation in a clinically integrated network.
- Provided advice and counsel to a hospital regarding the formation of a group purchasing organization.
- Provided advice and counsel to an academic medical center regarding regulatory changes associated with the COVID-19 pandemic.
- Provided advice and counsel regarding the implementation of the information blocking prohibition under the 21st Century Cures Act and the ONC’s final information blocking rule.
Fraud and Abuse
- Provided advice and written legal opinions on matters involving the federal anti-kickback statute, the physician self-referral law (Stark Law), the False Claims Act, Civil Monetary Penalties, and equivalent state fraud and abuse laws and regulations.
- Provided advice and counseling to hospital and physician group clients regarding the structuring of compliant arrangements, including physician incentive arrangements.
- Represented health care entities in regulatory compliance matters arising under Medicare, Medicaid, and other third-party reimbursement programs.
- Provided ongoing compliance advice and counsel to academic medical center and physician group clients.
- Advised and assisted clients in evaluating, developing, and implementing health care corporate compliance programs.
- Prepared treatment consent forms for hospitals, health systems, telehealth clients, and physician groups.
- Guided hospital clients through strategic affiliations and transactions, including mergers, acquisitions, joint ventures, and affiliation agreements.
- Negotiated various physician employment contracts on behalf of hospital systems and physicians.
- Negotiated various hospital service line agreements and amendments, including professional services agreements and co-management agreements.
- Conducted numerous health regulatory diligences for private equity clients in deals ranging from $500,000 to $1.2 billion.
- Prepared numerous clinical trial agreements, informed consents, and related documents.
- Drafted and negotiated numerous clinical trial agreements and facility use agreements.
- Provided advice related to FDA audits.
Telehealth and Telemedicine
- Provided advice to telehealth and telemedicine companies regarding compliance, reimbursement, and various legal and regulatory considerations.
- Advised clients on navigating federal and state changes in provider licensure during the COVID-19 public health emergency in order to provide services across multiple states.
- Advised health care entities regarding Florida regulatory and licensure matters involving Florida's Department of Health, Department of Business and Professional Regulation, and the Agency for Health Care Administration.
- Advised hospital client on market entry in light of Florida Certificate of Need repeal.
Privacy, Cybersecurity, and Data Asset Management
- Provided ongoing advice regarding the implementation of the 21st Century Cures Act.
- Assisted clients with privacy law analyses and compliance matters, including reviewing, revising, and drafting limited data use agreements and business associate agreements.
- Prepared HIPAA authorization forms for physician groups.
- University of Notre Dame Law School (J.D.)
- University of Notre Dame (B.S. and B.A.)
- University of Michigan (M.H.S.A.)
- Boston University (M.A., with honors)
- District of Columbia
- New Jersey
- Florida State Courts
- New Jersey State Courts
- U.S. Court of Appeals for the District of Columbia Circuit
- U.S. District Court, Middle District of Florida
- U.S. District Court, Southern District of Florida
- Florida Bar Association, Health Law Section, Co-Editor, Health Law Updates
- Hillsborough County Bar Association, Co-Chair, Healthcare Section
- American Bar Association, Health Law Section
- American Health Lawyers Association
- The New Jersey Bar, Health Law Section
- D.C. Bar Association, Health Law Section
- Healthcare Financial Management Association
- American College of Healthcare Executives
- The Junior League of Tampa, Member
- Notre Dame Club of Tampa Bay, Law Committee Co-Founder and Co-Chair
- Greater Tampa Chamber of Commerce
- Served as attorney ad litem for a child in dependency and delinquency proceedings in Hillsborough County, Florida (2019-2020).
- Advised, counseled, and advocated on behalf of a young adult transitioning out of the foster care system in Florida (2018).
- Prepared organizational documents and an IRS 1023 tax-exemption application for a student volunteer organization in Michigan; tax status was obtained (2017).
- Prepared organizational documents and an IRS 1023 tax-exemption application for an organization in Florida that helps veterans physically, financially, nutritionally, and occupationally; tax-exempt status was obtained (2015).
- Prepared organizational documents and an IRS 1023 tax-exemption application for an astronomy club in Indiana; tax-exempt status was obtained (2013).