Tracy Weir

Tracy E. Weir is a shareholder in the Firm’s Washington, D.C., office where she represents clients in a broad range of matters, including Medicare reimbursement and compliance, antitrust, administrative appeals before the Office of Hearings and Appeals, HIPAA/HITECH  and the 340B Drug Pricing Program.

Ms. Weir provides health care regulatory counseling to clients regarding issues pertaining to Medicare reimbursement and compliance, the 340B Drug Pricing Program, telehealth, and fraud and abuse. She also assists clients with payor audits, and routinely represents clients before the Office of Medicare Hearings and Appeals in administrative litigation involving denials of Medicare reimbursement.

Ms. Weir also counsels clients on data privacy and security matters that arise from federal and state laws, including HIPAA, HITECH and state data breach laws. She has substantial experience with HIPAA/HITECH compliance, including analyzing transactions and business relationships, preparing and negotiating business associate agreements, developing policies and procedures, and advising clients on data breaches and notification as well as handling Office of Civil Rights investigations. Additionally, she provides guidance to U.S. businesses regarding the EU’s General Data Protection Regulation (GDPR).

Ms. Weir has substantial antitrust experience in the areas of joint ventures, clinical integration and accountable care organizations; mergers and acquisitions; government investigations in the merger and non-merger context; and Non-Profit Institutions Act “own-use” exemption analyses. She has advised clients on issues arising from the Sherman Act, Clayton Act, Hart-Scott-Rodino Antitrust Improvements Act, Robinson-Patman Act and Federal Trade Commission Act.

As part of her practice, Ms. Weir has represented hospitals, physician groups, dental practices, community mental health centers, rehabilitation agencies, medical device suppliers, pharmaceutical companies, pharmacies, laboratories, organ procurement organizations, health insurers, technology companies and data analytics companies.

EDUCATION:

• Washington College of Law, American University, J.D., cum laude, 2002
• Rollins College, Paralegal Studies Program, Post Graduate Certificate, with honors, 1993
• Purdue University, with honors, B.A., 1992

ADMISSIONS:

• District of Columbia, 2004
• New York Bar, 2003

Representative Matters:

• Represented Medicare suppliers in cases before the Office of Medicare Hearings & Appeals in administrative appeals of Medicare reimbursement denials.
• Represented hospitals in connection with complex transactions involving compliance with Medicare regulations, including provider-based status, hospital-within-hospital and other payment and conditions of participation rules.
• Conducted audits and due diligence reviews for a broad array of clients with regard to compliance with Medicare standards, HIPAA, fraud and abuse, and 340B Drug Pricing Program compliance.
• Represented covered entities and business associates with regard to compliance with HIPAA and HITECH standards, including negotiating service and business associate agreements, preparing policies and procedures, and analyzing complex transactions and business relationships.

Professional Honors & Activities:

• Nightingale’s Healthcare News, Outstanding Healthcare Antitrust Lawyer (2007)
• Member – American Bar Association, Antitrust Section; Vice Chair, Health Care and Pharmaceuticals Committee (2007 – 2011)
• Member – American Health Lawyers Association