代表经验

Health Care Compliance and Regulatory

Kara has advised large hospital and health systems, physician practice groups, and pharmacies on wide ranges of federal and state health care regulatory compliance.

• Keeping various clients informed of COVID-19 related requirements and waivers, including CMS’ Hospital without Walls and Hospital at Home programs, Provider Relief Funds (PRF), and federal and state vaccination mandates.
• Advising health care entities on state regulatory issues including state licensing and change of ownership.
• Counseling physician and other clinician practices on the corporate practice restrictions on their professions.
• Assisting health care clients with a broad range of transaction matters, including mergers and acquisitions, affiliations, and formation of friendly professional corporations.

Health Care Litigations and Internal Investigations

Kara has represented companies, including medical devices companies, laboratories, and other health care industry participants, in investigations and litigation initiated by the federal government and whistleblowers. Kara has experience not only in the FCA and state FCA, but also in the Anti-Kickback Statute (AKS) and Stark Law. She analyzes, investigates, and litigates these statutes.

• Represented a laboratory company in False Claims Act and Anti-Kickback Statute matter alleging improper kickbacks in exchange for referrals.
• Assisted a large health care entity responding to a civil investigative demand (“CID”) related to alleged COVID-19 fraud.
• Provided health care counsel to a medical equipment company responding to DOJ allegation of False Claims Acts violation related to Medicaid reimbursement fraud.
• Represented a provider group in a False Claim Act, Stark Law, and Anti-Kickback matter alleging improper contracting to induce referrals.

远程医疗、远程保健、虚拟护理、数字健康

“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)

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.

• 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.