Wednesday // May 5th // 11:30 am

Session: Financial Inclusion: Banking in the Legal Cannabis Industry

Kate Hardey

Partner 

McGuireWoods

Kate advises healthcare provider, pharmaceutical, medical device, dietary supplement and life sciences clients on regulatory and compliance matters and in all types of transactions including sales and acquisitions , as well as advising lenders and investors evaluating regulatory risks in cash flow and asset based debt financing transactions.



She has a combined 25 years of law firm, in-house and healthcare industry experience. She represents various healthcare providers including physician practices, hospitals, academic medical centers, pharmaceutical and medical device manufacturers among others. Kate also advises businesses and lenders involved in the cannabis supply chain.


At the forefront of the industry, Kate currently serves on the Law360 editorial advisory board for life sciences where she advises the legal newswire on industry trends and issues facing companies, organizations, and law firms. Prior to joining McGuireWoods, Kate was Senior Regulatory Counsel at a leading middle market healthcare lender where she oversaw the healthcare regulatory diligence for all transactions. In this position, she partnered with the risk underwriting teams to create an effective, coordinated and streamlined diligence process to identify and mitigate complex compliance and regulatory risks.


Kate regularly advises on regulatory, financial and compliance risks for a range of issues including:


  • U.S. Food and Drug Administration (FDA) regulation, enforcement, manufacturing compliance; drug and device development; pharmaceutical and medical device sales and marketing compliance; product approvals
  • False Claims Act investigations and litigation, investigations conducted by federal and state agencies, anti-kickback and Stark law compliance
  • Cannabis matters including federal and state regulation of Hemp and Hemp extract containing products
  • Agriculture Improvement Act of 2018
  • Clinical Drug Trials
  • State Boards of Pharmacy and manufacturing and wholesale licensure;
  • Physician Payments Sunshine Act
  • HIPAA privacy and security
  • State regulation of telemedicine and electronic drug prescribing laws.
  • Coding, billing and revenue cycle management
  • Behavioral Health
  • Corporate practice of medicine
  • Laboratory compliance
  • Pharmacy
  • Physician dispensing, physician disciplinary issues, drug theft, and off-label drug use
  • Skilled Nursing, Home Health, Hospice


Kate worked as in-house legal counsel in a large ten-hospital health system where she served on hospital boards and leadership teams. She also counseled hospital clients on a wide range of legal issues such as physician contracting and employment, transactional matters, pharmacy compliance, real estate transactions, accreditation and licensure issues, medical staff matters, patient privacy and patient care issues.


Kate was the emergency department administrator at a major academic medical center where she directed physician contracting, compliance, finance, strategic planning and hospital emergency preparedness. She received an award for turning a department deficit into a significant profit in twelve months by developing comprehensive financial analysis and payer reimbursement monitoring program.


Kate is a business-focused attorney with demonstrated leadership and strategic planning skills. Her diverse legal and healthcare practice has kept her at the forefront of critical issues affecting the healthcare industry.


Kate Hardey

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