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Tracy E. Weir

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Tracy Weir 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.

Featured Videos

HHS Requests Comments on Proposed 340B Program Changes to Reduce Drug Prices June 13, 2018
Part III – So You Think GDPR Does Not Apply to American Companies? Think Again. March 14, 2018
Part II – So You Think GDPR Does Not Apply to American Companies? Think Again. February 21, 2018
Part I – So You Think GDPR Does Not Apply to American Companies? Think Again. January 17, 2018

Featured Experience

Represented Medicare suppliers in cases before the Office of Medicare Hearings & Appeals in administrative appeals of Medicare reimbursement denials.

Represented health care providers and health plans in connection with antitrust investigations by the Department of Justice and Federal Trade Commission. Substantial experience with joint ventures, clinical integration and third-party subpoenas.

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.

Professional Biography

Overview

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.

Representative Matters
  • Represented Medicare suppliers in cases before the Office of Medicare Hearings & Appeals in administrative appeals of Medicare reimbursement denials.

  • Represented health care providers and health plans in connection with antitrust investigations by the Department of Justice and Federal Trade Commission. Substantial experience with joint ventures, clinical integration and third-party subpoenas.

  • 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.

  • 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.

  • 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 clients before the Centers for Medicare & Medicaid Services in connection with regulatory and policy interpretation issues and billing revocation determinations; the Office for Civil Rights for HIPAA Privacy Rule investigations and data breach notifications; and the Health Resources and Services Administration, Office of Pharmacy Affairs, for 340B Drug Pricing Program compliance.

  • Served as privacy counsel to one of the largest providers of rehabilitation therapy in the country, including advice concerning the organization of a privacy and security compliance framework and assistance with HIPAA analyses on an on-going basis.
Professional Honors & Activities
  • Listed in The Best Lawyers in America® in the area of Health Care Law (2020)
  • Listed in Washington, D.C. Super Lawyers as a Rising Star in Health Care (2013)
  • 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
Publications
Speaking Engagements
  • "Legal Procurement Guide to the GDPR," Buying Legal Council Legal Lessons Series Webinar (April 2019)
  • "EU GDPR Implications for U.S. Employers: Top Questions and Tips" (June 2018)
  • "Southern Gaming Summit - Cybersecurity in a World Full of Threats" (May 2017)
  • "Medicare Fraud & Abuse: Implications for Physicians," Emerging Issues in U.S. Health Care Policy Conference, Southern Medical Association for Physician Executive MBA Program, Auburn University, Raymond J. Harbert College of Business (March 2017)
  • "Data Privacy, Security and Liability for Breaches," Tennessee Hospitality & Tourism Law Symposium, Nashville, Tennessee (July 2016)
  • "Medicare Claims Appeals: From Audit to OMHA," AdvaMed Medical Device Reimbursement Workshop (2014)
  • "340B Program: Audits, Corrective Actions, and Other Developments," King & Spalding Houston Lunch & Learn Roundtable (2014)
  • "Breaches, Business Associates, and Beyond: What You Need to Know About the New HIPAA/HITECH Regulations," King & Spalding Roundtable Program (2013)
  • "Overcoming Regulatory Hurdles," Baker Donelson Accountable Care Symposium (2011)

Awards

Education

  • Washington College of Law, American University, J.D., cum laude, 2002
    • American University Law Review, Associate Managing Editor
    • Legal Methods Dean's Fellow, 1999 – 2000
  • 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

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