Katie McKeon

Katie McKeon is a healthcare attorney in Holland & Knight's Boston office and a member of the firm's Healthcare Regulatory Compliance Team. Ms. McKeon focuses her national practice on counseling clients regarding healthcare regulatory, licensure, compliance and transactional matters.

Ms. McKeon advises clients on a range of complex healthcare regulatory issues, including:

• fraud and abuse, such as the Anti-Kickback Statute (AKS), False Claims Act (FCA) and Stark Law
• prohibitions on the corporate practice of medicine (CPOM)
• privacy and confidentiality, including the Health Insurance Portability and Accountability Act (HIPAA)
• Medicare and Medicaid overpayment and reimbursement issues and strategies
• compliance program implementation
• adherence to other federal and state healthcare laws

In addition to her regulatory experience, Ms. McKeon advises clients on complex transactions, including mergers, acquisitions, joint ventures, strategic alliances and partnerships. She also counsels healthcare clients on corporate matters such as contracting, employment and corporate governance as well as assists insurers and lenders on underwriting representation and warranties insurance (RWI). Ms. McKeon routinely advises clients on the regulatory aspects of healthcare transactions, including regulatory due diligence, licensure and enrollment approvals, change of ownership matters and post-closing regulatory implementation.

Ms. McKeon's experience encompasses advising a range of clients in the pharmaceutical distribution chain, including pharmacies (retail, mail order, specialty, compounding, long-term care and veterinary), infusion centers, pharmacy benefit managers (PBMs), and medical device and prescription drug manufacturers, wholesalers and distributors. She advises these clients on industry-specific regulatory and transactional matters, including multistate licensing and permitting requirements; initial applications, renewals and change of ownership processes; changes in name, ownership and control; and compliance with state and federal healthcare laws and regulations. Ms. McKeon also advises clients on controlled substance regulatory matters, including U.S. Drug Enforcement Administration (DEA) registration requirements, drug diversion investigations and compliance with federal and state-controlled substance laws and regulations.

Additionally, Ms. McKeon has substantial experience advising owners, operators and investors in the senior living industry on licensure, enrollment and regulatory matters involving assisted living facilities, memory care communities and other long-term care providers. Her practice includes obtaining and maintaining facility licenses and ancillary permits, navigating change of ownership, name change and management change approvals, analyzing state-specific operating requirements, and counseling clients on regulatory compliance, survey matters and interactions with state licensing authorities.

In the litigation and enforcement context, Ms. McKeon has experience representing clients in civil healthcare cases, with a focus on healthcare fraud and abuse.

While in law school, Ms. McKeon served as the assistant managing editor of the Connecticut Law Review. She also participated in the school's Environmental Law Clinic, where she worked with attorneys at a nonprofit organization to draft a citizen suit complaint and investigate municipalities' compliance with environmental regulations. Additionally, Ms. McKeon interned in the legal department of a major insurance company.