Tracy Weir

Health Care Regulatory

Tracy advises clients in connection with a variety of health care regulatory matters, with an emphasis on the laws and rules governing Medicare participation and reimbursement.  She has significant experience representing clients on matters concerning: 

• Medicare conditions of payment and coverage under Part A and Part B, including the rules and guidance governing provider-based status, hospital-within-hospital, under arrangement relationships, hospital-based and outpatient laboratory billing, RHCs and FQHCs, reassignment relationships, telemedicine and virtual care services, physician services, pharmacy services, and independent diagnostic testing facilities.
• Payor audits, including audits performed by specialty contractor audits, such as UPICs and RACs.
• Administrative litigation involving appeals of claims denials, including extrapolated overpayments.  Tracy routinely appears in hearings before Administrative Law Judges at the Office of Medicare Hearings & Appeals.
• Medicare and Medicaid enrollment requirements and challenging revocations of enrollment and effective date of enrollment actions. 
• Changes of ownership and successor liability.  Tracy has worked with hospitals and long-term care facilities in connection with updating enrollments and federal, state and local licensure following a change of ownership.
• State scope of practice and licensure for professionals, as well as state corporate practice of medicine laws arrangements, including managed practices. 
• Telehealth and digital health arrangements, including state laws governing telehealth providers and patient consent requirements, data flows and data uses, billing, coverage and payment, and contractual relationships.
• 340B Drug Pricing Program compliance, audits and manufacturer refunds as well as payor requirements for billing 340B-covered drugs.

Data Privacy 

Tracy routinely advises clients on data privacy and security matters that arise from federal and state laws. She has substantial experience with HIPAA/HITECH compliance requirements and other data and consumer privacy frameworks, including:

• Analyzing transactions, business relationships and innovative market offerings, such as data supplier/sharing arrangements, data analytics services, business associate and subcontractor services, as well as telehealth and digital health offerings and mobile applications.
• Advising clients regarding implementation of organized health care arrangements for clinically integrated networks and affiliated covered entity structures.
• Preparing and negotiating business associate agreements.
• Developing HIPAA/HITECH policies and procedures.
• Assisting clients with data breaches and notification, as well as handling Office of Civil Rights investigations.

• Co-Editor, Payment Matters (May 2020-May 2021)
• Co-Author, CMS’s Second Interim Final Rule Further Expands Telemedicine, Service Availability and Payment Flexibilities Related to the COVID-19 Pandemic, Payment Matters (May 19, 2020)
• Oral Arguments Scheduled in Challenge to 340B Payment Cuts While HHS Solicits Comments on Potential Remedy for 340B Hospitals, Health Law Alert (Sept. 2019)
• Co-Author, The New York Privacy Act: A Consumer Privacy Bill to Monitor Closely, republished in Westlaw Journal Bank & Lender Liability (July 2019)
• Co-Author, Court Again Strikes Down 340B Payment Cuts; Remands Unlawful Payment Rules to HHS to Provide Relief, Payment Matters (June 2019)
• Co-Author, CMS Issues Draft Guidance on Shared Space Arrangements, Payment Matters (May 2019)
• Co-Author, Government Appeals 340B Payment Cuts Decision; Question of Relief Continues in District Court, Payment Matters (March 2019)
• Co-Author, Administrative and Congressional Activity Related to the 340B Drug Pricing Program Likely to Continue in 2019, ABA HEALTH ESOURCE (February 2019)
• CMS to Issue Guidance on Shared Space Arrangements, Payment Matters (December 2018)
• Co-Author, CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals, Payment Matters (April 2018)
• Co-Author, The New Option in Town: Applying for the Low Volume Appeals Settlement, Alert (February 13, 2018)
• Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It’s Not Over, Payment Matters (January 2018)
• CMS’s Massive 340B Drug Pay Cut Policy Lands in Federal Court, Payment Matters (November 2017)
• OCR Examines Hybrid Entity Designation in Latest HIPAA Settlement, Alert (November 2016)
• Co-Author, Are You Ready? New Round of HIPAA Audits Are Underway, Alert (March 2016)
• Co-Author, Big Payment Changes Revealed in New Medicare Part B Drug Payment Test, Alert (March 2016)
• Co-Author, CMS Relaxes Proposal for Returning Overpayments, but Significant Questions Remain, Alert (February 2016)

• Co-Speaker, Managing the COVID-19 Vaccination in Your Workforce and Community (December 2020)
• Co-Speaker, Legal Procurement Guide to the GDPR, Buying Legal Council, Legal Lessons Series Webinar (April 2019)
• Co-Speaker, HHS Requests Comments on Proposed 340B Program Changes to Reduce Drug Prices, Webinar (June 2018)
• Three Part Series – So You Think GDPR Does Not Apply to American Companies? Think Again, Webinar (Jan., Feb. & Mar. 2018)
• Cybersecurity in a World Full of Threats, Southern Gaming Summit (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)
• Claims Appeals Developments and Proposals for Expansion, Webinar (August 2016)
• Data Privacy, Security and Liability for Breaches, Tennessee Hospitality & Tourism Law Symposium, Nashville, TN (July 2016)