Tracy Weir

Healthcare Regulatory
Tracy advises clients in connection with a variety of healthcare regulatory matters, with an emphasis on the laws and rules governing Medicare participation, reimbursement, and fraud and abuse matters.  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, multi-campus enrollments, under arrangement relationships, hospital-based and outpatient laboratory billing, RHCs and FQHCs, reassignment relationships, telemedicine and virtual care services, outpatient therapy services, physician services, pharmacy services, IDTFs, and behavioral health facilities.
• Internal and external compliance audits and investigations, including audits performed by specialty contractor, such as UPICs and RACs, and reporting overpayments.
• 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, long-term care facilities, DMEPOS suppliers and other types of entities in connection with updating enrollments and federal, state and local licensure following a change of ownership.
• State scope of practice and licensure for professionals and structuring arrangements to comply with state corporate practice of medicine laws, 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 and Security 
Tracy routinely advises clients on data privacy and security matters that arise from federal and state laws. She has substantial experience with HIPAA/HITECH and Part 2 compliance requirements and other federal data and privacy frameworks, including:

• Assisting clients with Office of Civil Rights investigations and compliance reviews.
• Analyzing transactions, business relationships and innovative market offerings, such as data supplier/sharing, longitudinal data, de-identified data arrangements, health information technology offerings, data analytics services, software-as-a-service (SaaS) arrangements, business associate and subcontractor services, as well as telehealth and digital health, 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 and data use agreements.
• Developing Information Privacy and Security Programs.

Healthcare Transactions
Tracy advises clients on acquisitions and divestitures of healthcare investments and assets on a full-range of healthcare regulatory issues and assists clients in navigating remediation activities identified in diligence.  Representative matters include:

• Representing a global healthcare services and products company in connection with $1.1 billion dollar acquisition of leading national DMEPOS suppliers.
• Advising private equity sponsors in connection with investments in companies with health IT platform offerings relating to physical therapy, laboratory services, behavioral health, nutrition services, DMEPOs, remote monitoring services, electronic health record and practice management systems, among others. 
• Advising operators in acquisitions of long term care facilities and behavioral health hospitals. 
• Advising portfolio firm concerning investment in company providing advanced data analytics, data abstraction and curation services and commercialization of real-world oncology patient datasets. 
• Advising venture fund on investment in technology company offering telehealth and telemental health services.
•  Advising private equity sponsors, operators, and franchisors on acquisitions relating to home and community-based care services (HCBS) platforms.

• Co-Author, California Governor vetoes further legislative efforts to restrict healthcare investments and management relationships, AKD Partners, (October 3, 2024)
• Co-Author, Court vacates OCR’s unlawful expansion of HIPAA, AKD Partners, (June 28, 2024)
• Co-Author, OCR updates guidance on tracking technology: Key takeaways, AKD Partners, (April 10, 2024)
• 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, Health Care Claim Life Cycle, AHLA Training for Department of Labor, Employee Benefits Security Administration, (September 2024)
• 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)