Kate W. Hardey Partner

Kate advises healthcare and life sciences clients on regulatory and compliance matters and in all types of transactions including sales and acquisitions, joint ventures, contractual affiliations, as well as evaluating regulatory risks in cash flow, asset- based and lending 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. 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 healthcare regulatory diligence. In this position, she partnered with the risk underwriting teams to create a coordinated and streamlined diligence process. Specifically, she evaluated and advised on financial and compliance risks associated with areas such as:

  • U.S. Food and Drug Administration (FDA) 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
  • State survey/certification and accreditation
  • HIPAA privacy and security
  • Coding, billing, payor audits and revenue cycle management
  • Behavioral Health
  • Corporate practice of medicine
  • Laboratory
  • Pharmacy
  • Physician and dental practices
  • 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 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.

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.

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

  • District of Columbia
  • North Carolina
  • Virginia

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

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