Kara Schoonover

Kara Schoonover is a health care lawyer with Foley & Lardner LLP and member of the firm’s Telemedicine & Digital Health and Health Care Industry Teams. She works with hospitals and health systems, physician practice groups, and emerging technology companies across the country. Her work focuses on federal and state regulatory compliance and business issues in health care.

Kara helps entrepreneurs and emerging companies navigate state and federal laws governing telemedicine and digital health, including federal and state COVID-19 public health emergency waivers, telemedicine modalities and technology, mail order pharmacy arrangements, telehealth-based substance use disorder treatment regulations, school-based virtual care programs, scope of practice and supervision requirements, and Medicaid enrollment.

Kara has also handled issues in FDA and government contracting compliance, including accidental and intentional adulteration for food companies, poison packing prevention for drug companies, and international regulations compliance for cosmetic and telemedicine companies. Additionally, she also analyzed burdens for False Claims Act cases, reviewed standards of operating procedures for health care facilities, and consolidated recent Office of the Inspector General opinions.

Before joining Foley, Kara held a clerkship for the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) where she worked extensively on exclusion appeals, self-disclosures, corporate integrity agreements, and reportable events. She also held an internship at the U.S. Attorney’s Office Western District of Missouri.

Telemedicine, Telehealth, Virtual Care, Digital Health

"Foley is the premier firm for telehealth counsel."
"A market leader in telemedicine issues." "This is the Dream Team."
     - Chambers USA: America's Leading Business Lawyers (2020 - 2021)

Selected representative matters include

• Telehealth-Based Substance Use Disorder Treatment. Helped an emerging digital health company involved in the treatment of opioid use. The advice included determining substance use disorder licensing requirements, controlled substance prescribing limitations, and nurse practitioner scope of practice, supervision requirements, and prescribing authority across multiples states. The work helped the company strategically determine potential market entry points for successful launch.
• Remote Patient Monitoring and Clinical Staff. Worked with several digital health companies offering remote patient monitoring services develop their corporate structure in various states. The work included advising on billing considerations along with nurse practitioner, nurse, certified nurse assistant, licensed vocational nurse, and medical assistant scope of practice and supervision requirements. The work allowed the company to comply with regulatory requirements while providing a scalable, affordable staffing model for RPM.
• School-Based Telehealth and Medicaid Enrollment. Advised a school-based telemedicine program offering telehealth services across multiple states, without any brick and mortar locations, on the requirements for enrolling in Medicaid programs. The work allowed the company to create a corporate structure that fit within its strategic growth plan and adhered to state laws and payer requirements.
• COVID-19 Licensure and Modality Waivers. Advised various telehealth companies on navigating federal and state changes in provider licensure and telehealth modalities during the COVID-19 public health emergency. The work allowed the companies to immediately take action and expand their platforms to provide services across multiple states.
• Direct to Consumer Televeterinary Service. Advised a pet pharmacy on options for direct to consumer virtual veterinary prescription offerings. The work involved advising on states’ corporate practice of veterinary medicine prohibitions, establishing veterinarian-client-patient relationship, and fraud and abuse concerns. The pharmacy was able to evaluate its corporate structure in compliance with various federal and state requirements.

Education and Professional Affiliations

Kara received her law degree (with honors) from Georgetown University, where she was a Resident Fellow and the Executive Editor for the Food and Drug Law Institute’s Food and Drug Law Journal. She is a graduate of Saint Louis University (B.S., summa cum laude), where she was President of the National Residence Hall Honorary and a member of Alpha Delta Pi.

Kara has been a member of the American Health Lawyers Association since 2016 and is part of the leadership development program working with the Tax & Finance Practice Group within this association.

Pro Bono Service

Kara has participated in pro bono work at Foley & Lardner LLP by researching and drafting green card applications as well as estate planning documents. Additionally, she spent a week participating in pro bono work in the criminal law division of the Legal Aid and Defenders Association in Detroit, Michigan; while there, she researched and drafted a memorandum on first amendment free speech and developed exhibits for a week-long attempted murder trial.

Publications

• Co-author, “New Jersey’s Telemedicine Business Registry: What You Need to Know,” Health Care Law Today (September 1, 2021)
• Co-author, “Chapter 9: The Alphabet Soup of Medicare and Medicaid Contractors,” American Bar Association’s Physician Law: Evolving Trends & Hot Topics 2021 (July 26, 2021)
• Co-author, “CMS to Permanently Cover Audio-Only Telemedicine for Mental Health,” Health Care Law Today (July 21, 2021)
• Co-author, “From Petri Dish to Main Dish: The Legal Pathway for Cell-Based Meat,” The Kentucky Journal of Equine, Agriculture, & Natural Resources Law (June 2021)
• Contributing author, “The risks of ‘swapping’ for durable medical equipment,” McKnight's Long-Term Care News (April 14, 2021)
• Co-author, “COVID-19 Food & Beverage Regulatory Updates,” Coronavirus Resource Center: Back to Business (September 8, 2020)
• Co-author, “COVID-19: Free Lodging, Free Testing, Free of OIG Enforcement?” Coronavirus Resource Center: Back to Business (August 10, 2020)
• Co-author, “COVID-19 Food & Beverage Regulatory Updates,” Coronavirus Resource Center: Back to Business (July 27, 2020)
• Co-author, “FDA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know,” Coronavirus Resource Center: Back to Business (May 6, 2020)
• Co-author, “Meat and Poultry Industry Gets New COVID-19 Guidance from CDC and DOL,” Coronavirus Resource Center: Back to Business (April 28, 2020)
• Co-author, “Implications for the Cannabis Industry Due to the Coronavirus,” Coronavirus Resource Center: Back to Business (April 17, 2020)
• Co-author, “COVID-19: Idaho Governor Suspends More Regulations Relating to Telehealth and Medical Licensing,” Coronavirus Resource Center: Back to Business (April 13, 2020)
• Co-author, “FDA Publishes Enforcement Policies to Address Coronavirus Personal Protective Equipment Shortages,” Coronavirus Resource Center: Back to Business (April 6, 2020)
• Co-author, “Managing the Commercial Impact of the Coronavirus: Food & Beverage,” Coronavirus Resource Center: Back to Business (March 6, 2020)
• Co-author, “Telehealth: Massachusetts’ Proposed Act to Improve Health Care by Investing in Value,” Health Care Law Today (January 29, 2020)
• Contributor, "Key Takeaways from USDA's Interim Hemp Production Rule," Foley Insights (November 1, 2019)

Admissions

• Maryland
• Colorado
• District of Columbia