Holley Thames Lutz, Partner

Ms. Lutz concentrates her practice in the areas of Medicare and Medicaid coverage and reimbursement counseling, administrative litigation and clinical research compliance.  She has been recognized by Chambers USA as one of the leading health care lawyers in the United States and most recently recognized by Chambers as one of America’s Leading Lawyers for Business 2009.  She also is featured in Nightingale’s Health News list of “Outstanding Hospital Lawyers - 2008”.  She represents academic medical centers, community hospitals, large physician groups, hospices and research institutions, as well as a broad array of other health care organizations.  In the Medicare and Medicaid arena, Ms. Lutz: 

• Counsels health care organizations with respect to Medicare coverage and reimbursement issues, including those relating to graduate medical education, disproportionate share payment adjustments, and Medicaid financing arrangements including provider-tax and supplemental payment models.
   
• Represents health care organizations in administrative litigation including PRRB and ALJ appeals.
   
• Interacts extensively with CMS, obtaining regulatory interpretations and policy clarifications on a wide range of coverage and reimbursement issues.
   
• Advises clients on formation and operational structure issues, including those relating to compliance with provider-based regulations, provider enrollment, and successor liability in the merger and acquisition context.
   
• With respect to EMTALA, Ms. Lutz reviews and revises provider policies and procedures, furnishes in-service training, defends providers against CMS allegations of non-compliance, and negotiates settlement agreements with HHS OIG.  

In the clinical research arena, Ms. Lutz: 

• Drafts and revises human subject protection programs, including policies and procedures relating to IRBs generally, IRB member and principal investigator conflicts of interest, and the informed consent process.
   
• Counsels providers on the application of the Medicare National Coverage Decision relating to services furnished in the context of clinical trials.
   
• Assists providers in connection with regulatory audits undertaken by ORI, FDA and OHRP, and defends providers against allegations of non-compliance.
   
• Drafts and negotiates clinical trial agreements with sponsors, CROs and SMOs.
   
• Assists providers in developing infrastructure to enhance federal research grant compliance.

American Bar Association; Chair - Payment & Reimbursement Interest Group

American Health Lawyers Association; Vice Chair - Research/Educational Programs

American Health Lawyers Association; Teaching Hospital and Academic Medical Centers Program Committee

Journal of Health and Life Sciences Law - Editorial Board

Virginia Bar Association

• “Clinical Research Reimbursement,” chapter author, 2009 Medicare and Medicaid Reimbursement Update (April 2009)
   
• “Hot Issues In Clinical Trials:  Enforcement of Federal Grant Accounting” (July 2008)
   
• “Scientific Misconduct - Revised and Revisited by ORI” (May 2008)
   
• “Clinical Research:  Medicare Coverage, Payment and Compliance Issues” (April 2008)
   
• “When Does a Sponsor’s ‘Promise to Pay’ in the Clinical Trial Setting Trigger Medicare Secondary Payer Liability?,” BNA Medical Research Law & Policy Report (Vol. 6, No. 20) (October 17, 2007)
   
• “CMS’ Proposed Decision Memorandum on the Clinical Research Policy”, BNA Medical Research Law and Policy Report, Vol. 6 No. 11 (June 6, 2007)
   
• “CMS’ Proposed Decision Memorandum on the Clinical Research Policy”, BNA Life Sciences Law and Industry Report, Vol. 1 No. 7 (June 8, 2007)
   
• “Clinical Research:  Medicare Coverage, Payment and Compliance Issues” (March 2007)
   
• “Institutional Review Boards: Their Role and Responsibilities in Clinical Research Programs”, chapter co-author, Clinical Research Compliance Manual (2006)
   
• "State Law:  The New Paradigm of Clinical Research” Clinical Trial Advisor, Vol. 9, No. 10 (May 27, 2004)
   
• “Medicare Prescription Drug, Improvement and Modernization Act of 2003 and Its Impact on Hospitals” (December 2003)
   
• “Are You Ready?” EMTALA Final Rules and Interim Interpretive Guidance (November 2003)
   
• OHRP Unveils Proactive Compliance Reviews (September 2002)
   
• “Hospital Reimbursement Issues”, chapter co-author, Health Law Handbook (1998)

• “We Thought We Knew How to Get Paid, OR What’s Old is New Again” - 11^th Annual Conference on Emerging Issues in Healthcare Law - ABA (February 2010)
   
• “What’s Old is New Again…Medicare Reimbursement/Enforcement Initiatives that TH/AMCs Should Keep on the Radar” - Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions - AHLA (January 2010)
   
• “Conflicts of Interest in Clinical Research, Enforcement Initiatives and FCA Update” - AHLA Annual Meeting and In-House Counsel Program) (June 2009) 
   
• “Fraud and Abuse Risks in Non-Academic Research Settings” - HCCA Compliance Institute (April 2009)
   
•  “Research Misconduct:  How Did We Get in this Mess and How Can We Avoid it in the Future” - Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions - AHLA (January 2009)
   
• “Medicare Clinical Research Policy:  Coverage and Payment Issues and Arguments” - AHLA Institute on Medicare and Medicaid Payment Issues (January 2009)
   
• “CMS’s Latest Guidance on Research Billing.  The Good, the Bad and the Really Ugly” - HCCA Web Conference  (December 2008)
   
• “Hospital-Acquired Conditions in Inpatient and Outpatient Settings” - CMS Listening Session (December 2008)
   
• “Quality Reporting and the Move toward Value-Based Purchasing:  Opportunities and Challenges” - ABA Washington Healthcare Summit (November 2008)
   
•  “CMS’s Latest Guidance on Research Billing.  The Good, the Bad and the Really Ugly” - HCCA Research Compliance Conference (October 2008)
   
•  “Hot Issues in Clinical Trials:  Enforcement of Federal Grant Accounting” - AHLA Annual Meeting (July 2008)
   
•  “Scientific Misconduct - Revised and Revisited by ORI” - AHLA Life Sciences Institute (May 2008)
   
• “Clinical Research:  Medicare Coverage, Payment and Compliance Issues” - AHLA Institute on Medicare and Medicaid Payment Issues (April 2008)
   
• “Clinical Investigations:  Institutional Review Boards (IRBs), Informed Consent, and the Investigational Device Exemption (IDE) - Food and Drug Law Institute (November 2007)
   
• “Federal Grant Accounting: Compliance and Enforcement” - HCCA Research Compliance Conference (October 2007)
   
• “CMS’ Draft Decision Memorandum on the Clinical Research Policy” - AHLA Teleconference (May 2007)
   
• “Enforcement and Federal Grant Accounting” - Society of Research Administrators International Midwest Section Meeting (May 2007)
   
• “Compliance Issues in Industry Clinical Trials - Effort, Third-Party Billing, Unreimbursed Expense, Large Balances: Need We Say More?” - Financial Research Administration Conference (April 2007)
   
• “Clinical Research:  Medicare Coverage, Payment and Compliance Issues” - AHLA Institute on Medicare and Medicaid Payment Issues Conference (March 2007)
   
• "Effort Reporting - The Latest Developments and Recent Cases" - HCCA Annual Research Compliance Conference (September 2006)
   
• “Fraud in Clinical Research - Anti-Kickback and Stark Law Issues” - Pennsylvania Bar Institute Clinical Research Symposium (August 2006)
   
• “Clinical Research: Medicare Coverage, Payment and Compliance Issues” - HCCA Compliance Institute (March 2006) 
    
• “Legal Issues in Medicare Reimbursement of Clinical Trial Services - Recent Developments” - AHLA Teleconference (February 2006)
   
• “OIG Model Compliance Guidance for PHS/NIH Awardees” - AHLA Audio Conference (January 2006)
   
• “Scientific Misconduct - Revised and Revisited by ORI” - Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions - AHLA (January 2006)
   
• "Effort Reporting and Compliance" - HCCA Annual Research Compliance Conference (June 2005)
   
• “Federal Research Grants” – HCCA Audio Conference (February 2005)
   
• “IRB Challenges and Compliance Tips” – Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions – AHLA (January 2005)
   
• “Fraud and Abuse and Clinical Research” (3-hour workshop) - CBI’s Forum on Limiting Exposure to Liability in Clinical Trials (December 2004)
   
• “Federal Research Grants: Strategies to Comply with Billing Rules and Avoid False Claims Allegations” – HcPro Audio Conference (October 2004)
   
• “Interaction between Medicare Part B and Medicare Part D” – National Medicare Prescription Drug Congress (February 2004)
   
• “Litigation and Clinical Trials” – Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions – AHLA (January 2004)
   
• “Understanding State Human Subjects Protections Laws Applicable to Clinical Research” – CBI’s Forum on Limiting Exposure to Liability in Clinical Trials (December 2003)
   
• Chairperson of CBI’s Forum on Limiting Exposure to Liability in Clinical Trials (December 2003)
   
• “Clinical Research Compliance” - GCD Biotech and Healthcare Strategies for Success Seminar (February 2002)
   
• “Compliance Issues and Clinical Research” - Healthcare Corporate Compliance Symposium in Atlanta, Georgia (May 2001)