HEALTHCARE:

• Assisted several hospitals and health systems with compliance program effectiveness/maturity assessments, compliance risk assessments, and Enterprise Risk Management (ERM)
• Led various engagements such as the development of annual compliance work plan and risk-based monitoring and auditing plans, including the design and implementation of compliance dashboards and analytics to identify opportunities and non-compliance
• Completed several compliance assessments and reviews for hospital inpatient/outpatient, professional, home health, hospice, inpatient and outpatient claims for psychiatry, clinical trial, hyperbaric oxygen therapy, and others; Performed medical record documentation review and related billing data analysis to identify areas of focus and potential non-compliance to relevant regulatory guidelines
• Led merger and acquisition (M&A) due diligence projects for large health systems, including assessment of compliance program, and coding, billing, and documentation practices via sample testing, interviews, and review of processes and controls to assess compliance with government payer guidelines; Focus areas including, but not limited to, general hospital and professional billing, skilled nursing facility, home health, and clinical research
• Led a number of internal investigations for large national healthcare providers that resulted in voluntary refunds/self-disclosure protocol to Medicare (Part A and B claims) and state Medicaid programs, and commercial health plans using statistical sampling
• Executed multiple Centers for Medicare and Medicaid Services ("CMS") six-year look-back and voluntary refund retrospective reviews for large healthcare providers; Applied statistical sampling methodology for sample selection, financial error calculation, and related extrapolations to determine repayment/refund amounts; Assessed compliance with Medicare conditions of payment and participation; Completed required remediation activities to address identified gaps (e.g., training, process enhancements, controls testing, etc.)
• Managed a number of clinical research/clinical trial billing compliance engagements at various healthcare systems in response to regulatory inquiries and as part of risk assessments or in collaboration with Internal Audit

LIFE SCIENCES:

• Assisted various life science companies with compliance program and risk assessments, including the design and development of risk-based monitoring and auditing plans
• Developed and implemented policies and procedures, compliance controls, training, and monitoring plans to meet commercial Pharma and Medical Device compliance standards and Corporate Integrity Agreement requirements
• Developed and delivered compliance training for clinical and non-clinical members of various healthcare and life science organizations focused on compliance requirements in connection with CIA, Compliance Program, Federal healthcare program requirements, Anti-Kickback Statute, False Claims Act, Conflict of Interest, Fraud, Waste, and Abuse, and the Stark Law
• Led compliance program effectiveness assessment for a large medical device company focusing on areas of Global Trade Compliance, Anti-Corruption Compliance, Data Privacy, Government Contracts, and Healthcare Compliance; Activities included inventory and evaluation of the current state, identification of gaps and improvement opportunities, development of a corporate compliance report for Board and senior leadership, and development of roadmap/compliance work plan to support implementation of recommended enhancements
• Coordinated commercial compliance assessment activities across six different countries for a large multinational life sciences company; Developed an audit plan and detailed assessment programs including review of the current state processes, evaluation of policies and procedures, and design and effectiveness of controls across several commercial compliance areas including, but not limited to, interactions with healthcare professionals, advisory boards, market access, market research, brand spend management, grants, etc.
• Conducted an assessment of the processes related to tracking and collection of Healthcare Providers and Healthcare Organizations spend, including direct remuneration, third-party payments, in-kind transfers of value, etc. for compliance with federal and state transparency reporting requirements
• Assisted a pharmaceutical company in developing and implementing compliance program enhancements in preparation for a Corporate Integrity Agreement with HHS OIG
• Participated in the development and support of management- and board-level compliance committees and related processes

• Co-speaker, "One goal, two teams – How to align to manage risk and perform audits," HFMA-NEHIA Joint Compliance and Internal Audit Conference, Mystic, CT, December 2, 2021
• Co-speaker, "Project Management in Compliance Programs," HCCA Boston Regional Healthcare Compliance Conference, Boston, MA, September 10, 2021
• Co-speaker, "Compliance Program Transformation – Opportunities, Strategies, and Creative Approaches," HCCA Compliance Institute, April 22, 2021
• Co-speaker, "Revenue Cycle Compliance Leading Practices," HFMA MA-RI Chapter Revenue Cycle Conference, January 14, 2021
• Co-speaker, “OIG Focus Areas,” Deloitte & Touche LLP and Foley & Larder LLP Compliance and Privacy Officer Roundtable, November 2017
• Speaker, “Clinical Trial Billing Compliance,” HFMA New Jersey Chapter Compliance Meeting, May 2015
• Co-speaker, “Anticipating Medical Necessity Denials, New Approaches to Defending Medical Necessity Denials,” Deloitte & Touche LLP Industry Webinar, October 2015
• “At the Intersection of Operations and Compliance,” The Wall Street Risk & Compliance Journal, September 2021
• “Relationships Are Critical to Compliance, Says AdventHealth Leader,” The Wall Street Risk & Compliance Journal, August 2021
• “Gateway Health CCO Touts Collaborative Compliance,” The Wall Street Risk & Compliance Journal, July 2021
• “With More Demands on Compliance, It Needs to be ‘Agile,’ Experts Say,” Report on Medicare Compliance, Health Care Compliance Association, May 2021
• “How Innovative Staffing Can Improve Compliance,” The Wall Street Risk & Compliance Journal, February 2021
• “Health Care Compliance Agenda: Relieve the Pressure,” The Wall Street Risk & Compliance Journal, November 2020
• “COVID-19 | Latest Regulatory Updates and Implications,” Health Care Financial Management Association Massachusetts-Rhode Island Chapter Blog, May 2020
• “Financial Relief for CARES Act, FEMA and other COVID-19 Programs and Reporting Considerations,” Health Care Financial Management Association Massachusetts-Rhode Island Chapter Blog, April 2020
• “All RACs Get OK to Audit Medical Necessity of Inpatient Psych; Keep Eye on Certifications,” Report on Medicare Compliance, Health Care Compliance Association, October 2017
• “Retail Health & Wellness – Innovation, convergence, and healthier consumers,” Deloitte Publication, October 2016
• “New Approaches to Addressing and Defending Medical Necessity Denials,” Health Care Financial Management Association Advisor Magazine, March 2016
• “Planning and Executing Enterprise-Wide Compliance Risk Assessments in Health Care Organizations,” Health Care Compliance Association Compliance Today Magazine, April 2015
• “Proceeding with caution: Third-party service vendors and compliance,” Health Care Compliance Association Compliance Today Magazine, October 2014