Tamra Harris

Tamra Harris

+1.423.682.6257

Overview

Tamra Harris is a healthcare attorney at Holland & Knight, guiding hospital systems, medical device companies and other health entities through complex enforcement actions, investigations and compliance efforts. Ms. Harris' areas of focus include the False Claims Act (FCA), Anti-Kickback Statute (AKS), Stark Law, and the U.S. Food and Drug Administration (FDA). Much of her practice involves aligning client-specific business operations within existing regulatory frameworks and working with government agencies to create a path forward for innovative technologies and methodologies.

Ms. Harris has a distinct skill set in data analytics, implementing forensic methodologies generally reserved for outside consultants. This use of data has proven essential to health entities in complex risk analyses, defense of external investigations and calibration of internal operations. Drawing from her experience in crisis management, Ms. Harris works to reduce interruption, allowing her clients to continue providing critical healthcare services nationwide and abroad.

Ms. Harris' extended legal background includes volunteering at Nicaragua's Human Rights Commission and working with state legislators to combat human trafficking.

Representative Experience

Regularly defends health entities in government audits, investigations and litigation
Supports clients in building robust healthcare compliance programs
Experienced in developing healthcare regulatory work plans aligning with shifts in commercialization and company expansion
Supports global enterprises along with subspecialties, such as cardiology, neurology, oncology, organ transplant, diagnostics, biologics, pain management, skin substitutes and others
Experienced in defending U.S. Food and Drug Administration (FDA) enforcement actions; conducting policy gap assessments; providing FDA regulatory advice; and policy drafting for complaint handling, medical device reporting, and advertising and promotion (e.g., HCEI, off label promotion, pediatric use, etc.)
Knowledgeable in industry codes for AdvaMed, MedTech, PhRMA and EFPIA
Experienced in minimizing business interruptions for clients through crisis management protocol
Regularly advises clients on Sunshine Act questions
Implements advanced investigative analytics to Electronically Stored Information (ESI) and drafts corresponding ESI protocols
Conducts complex data analyses using Structured Query Language (SQL) coding
Combines use of structured and unstructured data, as needed, throughout each practice area

Lead defense of multiple concurrent False Claims Act (FCA) investigations, implementing extensive workflows, Structured Query Language (SQL) analytics, Electronically Stored Information (ESI) tools, system mapping, user interface portal design and visual presentations to educate the U.S. Department of Justice (DOJ) on innovative processes and systems
Drafted a healthcare compliance program to assist sales agencies of a global medical device manufacturer
Analyzed overpayment risk and recommended software and policy revisions for oncology practices based on electronic health record (EHR) systems, billing roles, medical record documentation, physician training and compliance
Assisted a medical device manufacturer in complex 483 observation responses reconciling technical equipment, cloud-based systems, medical conditions, standard operating procedures (SOPs), regulatory landscape, health hazard evaluations, field advisory notices and 806 Report responses
Advised a medical device manufacturer on U.S. Food and Drug Administration (FDA) and healthcare compliance needs related to advertising and promotion, medical device reporting, complaint handling, clinical operations and system processes
Assisted air ambulance providers with implementation of No Surprises Act
Conducted new hire compliance training sessions for a global medical device company
Successfully obtained a temporary restraining order (TRO) and prevailed in a preliminary injunction hearing in favor of pain management facilities, then prevailed in a full attorneys' fee award in favor of pain management facilities
Assisted a national inpatient rehabilitation system with COVID-19 reporting requirements
Successfully appealed numerous overpayment rulings through multiple levels of administrative review and oral argument, leading to dismissal of vast majority of overpayment decisions in favor of a managed care facility
Developed work plans for offshoring and remote diagnostic work
Successfully minimized risk for a client after a workplace explosion in working with various third-party organizations