Kate W. Hardey Partner

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.

"My extensive healthcare experience provides a unique perspective in counseling clients. I am able to provide clients with creative strategic solutions by considering not only the specific legal issues, but also the larger business implications."

Experience

Representation of National Securities Corp., acting as exclusive placement agent, in connection with a private offering and sale of preferred stock by Cyprium Therapeutics, Inc., a clinical-stage biopharmaceutical company.   

Representation of Alliance Global Partners (AGP), a regional investment and advisory firm providing investment advisory and brokerage services to individuals and institutions, in connection with the launch of an at-the-market program in which AGP serves as placement agent to ProPhase Labs, Inc. (Nasdaq: PRPH), a manufacturing and marketing company with experience with OTC consumer healthcare products and dietary supplements.  

Representation of financial services firm Barings LLC in connection with Kanwa Holdings LP’s $19 million acquisition of Midatech Pharma US from Midatech Pharma Plc.

Representation of a leading OB/GYN practice with offices in the Washington D.C. metropolitan area in a multi-million dollar sale to an integrated healthcare delivery company based in the Mid-Atlantic.

Representation of ExlService Holdings, Inc. (Nasdaq: EXLS), an operations management and analytics company, in its purchase of substantially all of the assets of Health Integrated, Inc., a Tampa-based healthcare analytics firm.

Advised on and analyzed healthcare regulatory risks for over 350 middle market cash-flow, asset-based and life science transactions for customers in all sectors of the healthcare industry.

Conducted internal compliance reviews and audits and crafted responses to civil and criminal investigations conducted by federal and state government agencies for hospital, pharmaceutical and device clients.

Advised pharmaceutical and medical device manufacturers on FDA matters including, pedigree, and state pharmacy/distribution laws, product development and labeling requirements.

Advised pharmaceutical and medical device manufacturers regarding compliance with federal and state marketing/gift disclosure laws, PhRMA and AdvaMed Code compliance.

Trained pharmaceutical sales representatives on current law as it relates to the promotion of drug products

Drafted policies and procedures for research and conflict of interest programs and developed compliance training materials related to the drug and device clinical trial process for a large clinical research institution.

Participated as an adjunct member of the promotional review committee for a large pharmaceutical manufacturer.

Advise lending institutions on appropriate policies, procedures and compliance review for direct and indirect businesses in the cannabis space.

Drafted and review medical staff by-laws, physician relationship and medical staff supervision policies for various hospital clients.

Drafted various reimbursement advocacy pieces for federal health care program coverage.

Successfully resolved a Joint Commission patient complaint in favor of the hospital client.

  • The Catholic University of America, Columbus School of Law, JD, cum laude, 2003
  • Marymount University, MS, Healthcare Management, 1999
  • George Mason University, BA, English, 1991

Member, Editorial Advisory Board, Life Sciences, Law360, 2018 - present

Board Member, Domestic Violence Legal Empowerment and Appeal Project, DV LEAP

Board of Directors, Secretary, MedStar National Rehabilitation Hospital, 2011-2013

Board of Directors, Secretary, MedStar St. Mary’s Hospital, 2011-2013

  • Virginia
  • North Carolina
  • District of Columbia

The rules of professional conduct in some jurisdictions require disclosure of selection methodology for certain public accolades and recognitions. Click here to view available selection methodologies.

Named a "Cannabis Law Trailblazer", The National Law Journal, 2020

Selected for inclusion as a "Leading Lawyer," Healthcare: Service Providers, Virginia, Legal 500 US, 2017

Back to top