not for publication in any form other than litigation consulting with permission when retained Michael F. Arrigo [email protected] +1949-633-5664 Offices in Boston, Pittsburgh, New York, Washington DC, Nashville, Raleigh, Atlanta, Miami Seattle, Salt Lake City, Denver, St. Louis, Chicago, Dallas, San Francisco, Palo Alto, Orange County, San Diego, Honolulu Education • Harvard Law School, Cambridge MA - Studies in Bio Ethics the study of ethical, legal, technological and social issues in biology and medicine including genetic testingi • Stanford Medical School, Palo Alto CA - Studies in Biomedical Informatics and mobile health ii • University of Southern California, Marshall School of Business, Los Angeles – Bachelor of Science, Business Administration, 1981; studied in Entrepreneur Program which focuses on the management, marketing and finance of startups, first of its kind U.S. D • Clinical documentation, medical coding, billing reimbursement, HIPAA transactions, value based care, risk adjustment (see Attachments in this CV). E Professional Affiliations N • Medical Group Management • American Society for Clinical Association (MGMA) Pathology (ASCP) I • Health Information Management • Information Systems Audit and A Systems Society (HIMSS) Control Association (ISACA) • American Academy of Professional • Volunteer, Children’s Hospital Medical Coders (AAPC) T innovation committee • American Health Information • Guest lecturer, Contributor, Strategic Management Association (AHIMA) Financial Management Newsletter, E • American Academy of Pain Medicine Healthcare Financial Management (AAPM) Association; R • Workgroup for Electronic Data • Prior contributor, Healthcare IT News, Interchange (WEDI) GovHealth IT, Mobile Health News, • Association for Clinical Financial Health News Documentation ImprovemTent Specialists (ACDIS) O Additional Coursework and Training • VillanovaN University – Lean Six Sigma and Process improvement 2007 • Wharton School, University of Pennsylvania – Leadership Strategies - 1982 • University of Calif., Irvine – Computer Science, Statistics, Economics ‘76 – ‘78 1 not for publication in any form other than litigation consulting with permission when retained Legal Experience (See Separate Document for List of Cases & Opinions) 1. Retained by U.S. DOJ re: Federal investigation into medical data, Health IT / E.H.R. stimulus funds and False Claims Act with estimated value of over $900 million 2. Presentations before FBI, Department of Justice, and U.S. HHS Office of Inspector General involving federal investigation under the False Claims Act. 3. Retained by former RAND Economists and Health IT firm for testimony before Federal Trade Commission involving anti-trust, access to clinical data impacting billing & revenue cycle. 4. Retained in two white collar crime cases, alleged fraud valued at over $5 million each 5. Federal, State, written testimony in expert reports, depositions, and court appearances re: ACA, HIPAA, medical coding and billing, usual customary and reasonable cost of care, Medicaid Expansion, Medicaid waivers for disabled insureds, and ACA Qualified D Health Plans, ERISA / Taft-Hartley Trusts, subsidies, rates and actuarial value. 6. Engaged by plaintiffs, class action attorneys, relators, defendants with experience E across payors (including Medicare, Medicaid, social security, workers’ compensation, private insurance / health plans, ERISA / Taft-Hartley plans), providers (including N hospital systems, physician groups, FQHCs, ASCs, IDTFs), patients, healthcare IT, (see Attachments for experience in various medical sIpecialties). A 7. User of eDiscovery tools such as Relativity for document discovery work, structured methods to review large case files with over 50,000 pages in complex litigation. T E Industry Awards and Recognition Arrigo, M. F. 2016 Nominee, Best LRegal Blogs of 2016 for healthcare industry sector, No World Borders, Inc. T Publications & Lectures O Arrigo, M. F. (2016) Strategic Financial Management for Healthcare Providers: Clinical Documentation Improvement and Accuracy as a N Foundation Value Based Care. Peer review, review by clinical and business executives at Baptist Health, a large academic medical center. Healthcare Financial Management (HFMA). Published August 17, 2016 https://www.hfma.org/sfp/ 2 not for publication in any form other than litigation consulting with permission when retained Arrigo, M. F. (2015) Mobile Health, HIPAA Privacy and Security Blackberry Sharpens Security with Good Technology Acquisition. Gov. Health IT http://www.govhealthit.com/blog/commentaryblackberry-sharpens-security-good- technology-acquisition Arrigo, M. F. (2015) Five Interest-Piquing Trends at HIMSS15. Gov. Health IT http://www.govhealthit.com/news/5-interest-piquing-trends-himss15 Arrigo, M. F. (2014) Cloud and Mobile Convergence: The Regulatory View. Gov. Health IT http://www.govhealthit.com/blog/cloud-and-mobile-convergence-regulatory-view Arrigo, M.F. (2014) HIPAA Plain and Simple / HIPAA for Behavioral Health – Credible Behavioral Health E.H.R. Software Users Conference, Baltimore Maryland (18 March 2014) D Arrigo, M.F. (2014) DSM 5 and ICD-10 – Credible Behavioral Health E.H.R. Software E Users Conference, Baltimore Maryland (18 March 2014) N Arrigo, M.F. (2014) Managed Care and Accountable Care for Behavioral Health – Credible Behavioral Health E.H.R. Software Users Conference, BaIltimore Maryland (18 March A 2014) T Arrigo, M. F. (2011) ICD-10 financial impact vs. mortgage crisis? Gov. Health IT E http://www.govhealthit.com/news/could-icd-10-have-big-financial-impact-mortgage-crisis R Arrigo, M. F. (2012) How a Flaw in the ACO Model Leaves Patients Out. Gov. Health IT http://www.govhealthit.com/news/how-flaw-aco-model-leaves-patients-out T Arrigo, M. F. (2012) 10 ICD-10 Regulation Myths Demystified. Gov. Health IT O http://www.govhealthit.com/news/10-icd-10-regulations-demystified N Arrigo, M. F. (2012) Real-time location, mobile health gain traction. Gov. Health IT http://www.govhealthit.com/news/real-time-location-and-mobile-health-solutions-gain-traction-show-roi Arrigo, M. F. (2013) 3 Top Priorities for CommonWell. Gov. Health IT http://www.govhealthit.com/news/3-top-priorities-commonwell 2 not for publication in any form other than litigation consulting with permission when retained Arrigo, M. F. (2013) Commentary: ICD-10 Arrives Early, New Claims Form. Gov. Health IT http://www.govhealthit.com/news/commentary-icd-10-arrives-early-claims-CMS-coding-HIPAA-icd-9 Arrigo, M. F. (2014) Increased Spending - Big Data, Cloud, mHealth Social. Gov. Health IT http://www.govhealthit.com/blog/increased-spending-and-savings-tap-big-data-cloud-mhealth-and-social Arrigo, M. F. (2014) Ebola: How cloud, mHealth, and ICD-10 could help. mHealth News http://www.mhealthnews.com/blog/ebola-how-cloud-mhealth-and-icd-10-could-help Arrigo, M. F. (2014) How Cloud and mHealth Ease Claims Processing (also coverage of Prior Authorization / eligibility HIPAA EDI 270/271, referral EDI 278 transaction. Gov. Health IT http://www.govhealthit.com/news/how-cloud-and-mhealth-promise-ease-claims-processing D Arrigo, M. F. (2014) How to Get Behavioral Health Codes Right. Gov. Health IT E http://www.govhealthit.com/blog/how-get-your-behavioral-health-codes-right N Lectures, Adjunct Faculty, Conference Speaking Engagements I A • Arrigo, M. (Speaker) (2015, November 2015) Medical Device Reimbursement, FDA, FCC and CMS regulatory disruption and opportunities under the Affordable Care T Act, ICD-10 and HITECH Act. BioMed Device and Wireless Device Conference, San E Jose California R • Arrigo, M. (Speaker) (2015, September 2015). Meaningful Use of Electronic Health Records, HIPAA Privacy and Security and potential damages for breaches under the HITECH Act as a foundaTtion for the International Classification of Diseases from the World Health Organization (ICD-10) – Discussion of risks and opportunities in these two O regulations; discrete data, quality measures, medical codes: clinical Documentation, clinical decision support, physician and patient engagement, HIPAA Privacy and Security N and revenue cycle. Wolters Kluwer Corporate event presented to audience of over 1,800 participants. 3 not for publication in any form other than litigation consulting with permission when retained • Arrigo, M. and Nichols J. MD - (Speakers) (2013, November). Claims Data, Clinical Data – Working together to Improve Clinical Documentation for International Classification of Diseases from the World Health Organization (ICD-10). Workgroup for Electronic Data Interchange (WEDI) National Conference. • Arrigo, M. (Speaker) (2012, April 14). The Perfect Storm in Healthcare - How Disruptive Regulations and Technologies Create Risks and Opportunities for Medical Coding and Revenue Cycle Management. Affordable Care Act, ICD-10, CORE Operating Rules, and HITECH Act. American Academy of Professional Coders (AAPC) National Conference. Lecture conducted from Las Vegas, NV. http://news.aapc.com/icd-10-monitor- wish-i-were-in-las-vegas/ • Arrigo, M. (Speaker) (2012, June 14). ICD-10: Impact on Payment Reform. Wisconsin D Medical Society. Lecture conducted from Madison, Wisconsin. http://bit.ly/16acIDy • Arrigo, M. (Speaker) (2013, April 23). The Perfect Storm in HealthcaEre - How Disruptive Regulations and Technologies Create Risks and Opportunities for Medical Coding and Revenue Cycle Management. Affordable Care Act, ICD-10, CORE Operating Rules, and N HITECH Act. Scripps Healthcare Summit 2013. Lecture conducted from La Jolla, San Diego California. I • Arrigo, M. (Speaker) (2012, May). How ICD-10 and PaAyment Reform Will Change the Radiology Revenue Cycle. Radiology Business Management Association (RBMA), Orlando Florida. T • Arrigo, M. (Speaker) (1994 - 1995). Impact of the Internet on medical and financial E businesses, Loyola University, Los Angeles CA • Arrigo, M. (Speaker) (1994 - 1995).R Impact of the Internet on medical and financial businesses, University of California, Irvine CA 2010 to present Instructor, HIP AA Privacy and Security, HITECH Act Electronic Health T Records, value based care, medical coding and billing audits, Affordable Care Act, Best practices in HIPAAO and HITECH Act Information Privacy and Security1 and Meaningful Use, Best practices Health IT, process improvement, eligibility and coverage determinations for value based Ncare2 Recent courses included instruction at these venues: 1 Trained by published author in HIPAA privacy and security and advisor to CMS, HHS on Meaningful use of Electronic Health Records, currently lead training sessions for HIPAA covered entities 2 Lead training for pharmacists, hospitals, physicians, health IT value based care firms 4 not for publication in any form other than litigation consulting with permission when retained • American Health Information Management Association 2016, Baltimore, MD • JP Morgan Healthcare Conference 2015, San Francisco, CA • Wolters Kluwer 2015 webcast • Duke Life Health System 2013, Pittsburgh, PA • HIMSS 2014 • AAPC Annual Conference 2012, Las Vegas Non- Litigation Consulting in Healthcare, Software, Financial Services 2007 to Present - No World Borders – I lead a healthcare data, regulatory, and economic consulting firm as Managing Partner. Our business provides advisory services on disruptive health care regulations for hospitals, insurance companies, self-insured employers, and health IT companies and investors. Summary of Accomplishments and Experience D I work with hospital systems, physician groups, and health IT companies, health plans, investors, and law firms. I was selected as an expert for a landmark Federal Trade Commission case regarding healthcare data, regulations and economics. I currently E serve as managing partner of No World Borders. I am: • A writer and speaker quoted in Wall Street Journal, and a regular speaker with N published works as an expert in the field. • Prepared by leading litigation firm in Rule 702 includinIg applying scientific or A specialized knowledge Federal rules (702(a)); facts (702(b)); application of principles and methods (702(c)); application of criteria, principles, methodology, test methods T (amended in Daubert, 2000 - (702(d)) before FTC Commissioner. E • An advisor to value based care companies including Medicare Advantage, Medicare Shared Savings Accountable Care Organizations. R • Led investor diligence on $4 billion in health care merger and acquisition transactions. • Trained in clinician, coder, medical billing, claims, E.H.R, hospital and practice T management software, regulatory, usual, customary and reasonable (UCR) medical and prescription cOharges. Application of Inpatient Prospective Payment System (IPPS), Outpatient Prospective Payment System (OPPS), Medicare Physician Fee Schedules N (MPFS) Part A, Part B, Physician Fee Schedules, U.S. standard wage indices, geographic adjustment factors (GAFs), market charges comparisons, where no collateral source rule is at issue, market reimbursement by health, auto, liability payors. 5 not for publication in any form other than litigation consulting with permission when retained • Opinions on over $1 billion in medical reimbursements for inpatient facilities (inpatient prospective payment system or IPPS and DRGs, ICD-9) and ambulatory (non-facility using CPT codes) D E N I A T E R T O N 6 not for publication in any form other than litigation consulting with permission when retained Regulatory Consulting for Health Care Provider and Healthcare I.T. Firms I competed for, won and led these among other account engagements where large global firms were also bidding on the business: • Duke Life Point Academic Medical Ctr Pittsburgh - ACO, ICD-10, Revenue Cycle Strategy; HCC risk adjustment for Medicare Advantage. Evaluate over $1 billion in health care claims for risk adjustment, audit quality using RADV methods, clinical documentation coding quality. Evaluate Meaningful Use compliance risk with respect to storage and security of discrete data from medical records, data conversion strategies, analytics strategies. • Advisory to E.H.R., Accountable Care Organizations, practice management IT companies - manage a team that has advised over 100 companies on Meaningful Use, D Medicare Advantage, ACA, ICD-10 regulations. Ambulatory, acute care – MU1, MU2, DSM-5, CPT, ICD-9, ICD-10, clinical documentation, HIPAA, Clinical Quality Measures, E CA Civil Code §56; • Nemours Children’s Hospital, Orlando Florida Meaningful UsNe of Electronic Health Records, HIPAA transactions for claims processing, HIPAA secure clinical and physical I plant data interoperability strategy of clinical and health care claims data using enterprise A web services solutions. Sharing of data in emergencies between clinical staff and security to protect pediatric patients. T • Credible, Inc. a leading behavioral health electronic health record software vendor E Advise regarding compliance with HIPAA Privacy and Security in general and specific R privacy and security rules for the Behavioral Health specialty, International Classification of Diseases version 10 versus Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5), Accountable Care Organizations and Managed Care for Behavioral T Health. O N p y g g p Regulatory Consulting for Health Plan, Self-Insured Employer Regulations I competed for, won and led these among other account engagements where large global firms were also bidding on the business: • Excellus Blue Cross Blue Shield – Rochester New York. Lead consulting engagement to remediate health plan enrollment process and TriZetto Facets Claims system. Rescue project from off-budget, off plan and restore to on time on budget. • Blue Cross Blue Shield / Triple – S (Salud Puerto Rico) – Lead implementation of TriZetto QNXT claims system including all process models, software implementation and project management office. • Preferred Care – Florida - Medicare Advantage HEDIS 5-Star Ratings, provider network clinical data, Utilization Management, Coordination of Benefits, Case Management and claims processing, chart review quality audits and analytics, risk adjustment using HCC and ICD-9 coding, RADV audit methods, RAPS file analytics. • United Healthcare, Florida - Medicare Advantage HEDIS 5-Star RatingsD, provider network clinical data, Utilization Management, Coordination of Benefits, Case Management and claims processing using HCC and ICD-9 coding, RADV audit methods, RAPS file analytics. E • Public Employees Health Plan – Salt Lake City Utah – Advise and assess re: new N medical coding and medical policy management remediation to comply with ICD-10 which impacts medical policy plan design, actuarial processes, covered amounts, utilization management, eligibility, referrals, covered Iamount and other factors. A • Regence BlueCross BlueShield, Seattle, Salt Lake, Portland - HITECH Act, HIPAA 5010, ICD-10 processes, DRGs, Ambulatory claims, Ancillary Services, and T IT architecture to enable these capabilities which impacts medical policy plan design, actuarial processes, covered amounts, utilization management, eligibility, referrals, E covered amount calculations and other factors. • Walmart – largest self-insureRd non-military employer globally – advice regarding ERISA Plans, Taft-Hartley Trusts, Minimum Essential Coverage, HIPAA insurance claims transactions, CORE operating rules, ICD-10, Affordable Care act business and regulatory issues and underlying systems and process issues for the largest self- T insured employer in the world. • TennCare – TeOnnessee Medicaid and TN Insurance Exchange eligibility • Citra Health Solutions, Jacksonville FL – Advisor to CEO. Advise leadership N regarding value based care, HIPAA privacy and security, meaningful use, strategic partnerships and acquisitions for Medicare Advantage and Accountable Care market. Focus on Value Based Pricing, Medicare Advantage Risk Adjustment using HCCs; population health, patient and physician engagement and quality reporting. p y g g p Investor Diligence - $4 billion in Health IT M&A transactions Selected as advisor, investor diligence on large healthcare mergers and acquisitions. • London PE Firm - pre-IPO cloud security business for healthcare. • Kleiner Perkins Caufield & Byers, Silicon Valley – work with founding partners of VC that funded Google, Netscape, Amazon, Amgen, Intel, Sun Microsystems on largest cloud healthcare investment in Medicare Advantage and Accountable Care population health management and analytics • In-Network and Out of Network medical charges, 340B Drug discount provider • NY PE Firm – diligence on $500 million acquisition of Medicare Administrative Contractor (MAC) electronic data connectivity and services company. Evaluate financial projections and growth potential, capabilities regarding claims status, new EDI standards, medical policy plan design, actuarial processes, covered amounts, utilization management, eligibility, referrals, covered amount calculations and other factors. D Medical Device, Pharmaceutical Regulatory Compliance Abbott Labs, Medical Optics Div (formerly Advanced Medical Optics) - Regulatory E Affairs, FDA Compliance – led global complaint handling roll out (US, UK, EU, Asia) of pharmacovigilance solution supporting FDA Adverse event reporting rules, National Drug Codes (NDCs), HCPCS, formularies, and health insurancNe coverage determinations for pharmaceuticals. Consulted to Optics division on global FDA Adverse Event reporting system, pharmacovigilance system for medical devices and I pharmaceuticals. A Led hardware and software development team through IQ/OQ/PQ process (IQ stands for Installation Qualification. OQ is Operational Qualification and PQ is Performance T Qualification. Before you even get to IQ, OQ, PQ, if you're acquiring a new piece of equipment, you'll need design specifications that define exactly what's in that piece of equipment) for FDA approval for medicalE device. R Prior Experience October 2002 to February 2T007 – First American / CoreLogic - SVP eCommerce – Banking solutions $8 billion firm. Led one of the largest most complex Sarbanes Oxley IT O audits in the U.S. according to attorneys and accounting firm. Led roll out of single platform eCommerce solution to integrate Wells Fargo, JP Morgan Chase, Bank of America and other N transactions for mortgage loan origination (credit, valuation, tax, flood, title, etc.), closing, securitization. 2002 to October 2003 – Fidelity - SVP eCommerce – Banking solutions $12 billion firm