Tracy Weir provides healthcare regulatory counseling on issues pertaining to Medicare reimbursement and compliance, telehealth, digital health, HIPAA/HITECH, and data privacy.
Tracy works with all types of health care providers, including hospitals and institutional providers as well as with physician groups, RHCs, FQHCs, DME suppliers, pharmacies, laboratories, therapy groups, providers of ancillary services. She also counsels health information technology companies and other clients that provide services, or seek to invest in companies, in the health care sector. She represents clients before the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Office for Civil Rights, and Health Resources and Services Administration.
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.
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.
- J.D., American University, Washington College of Law
Associate Managing Editor, American University Law Review
- B.A., Purdue University
- Chambers USA
- Band 4, District of Columbia Healthcare (2021-2023)
- Best Lawyers in America®, Health Care Law (2020-2021)
- Super Lawyers Magazine, Rising Star, Health Care (2013)
- Nightingale’s Healthcare News, Outstanding Healthcare Antitrust Lawyer (2007)
- 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)
Memberships And Affiliations
- American Health Lawyers Association
- American Bar Association
- DC Bar Association
My latest insights
DLA Piper advises Times Higher Education in its acquisition of Inside Higher Ed
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6 January 2022 .4 minute read