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Healthcare Data Regulations Economics Medical Billing Expert Witness

Provides Opinion & Testimony In:

Healthcare Data, Healthcare Regulations, Healthcare Economics, Medical Billing, Health Plans, Self Insured Employers, Hospital Data Systems, Physician Groups, Medical Device, Pharmaceutical, Health IT, Medical Billing, Coding, HIPAA Privacy, HIPAA Security Rule, Hospital Safety Processes, Electronic Health Record Forensic Audits, Medicare Fraud, Medicare, Medicaid, SCHIP Extension Act, Controlled Substances Act, Pain Management Auditing, Opioid Prescribing, Affordable Care Act Rebuttal, Life Care Plan, Future Costs of Care, Reasonable Value of Medical Expenses

EXPERT 5037

California

Summary of Accomplishments and Experience

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 serve as managing partner.

I am:

  • A writer and speaker quoted in the Wall Street Journal, and a regular speaker with published works as an expert in the field.
  • Prepared by a leading litigation firm in Rule 702, including applying scientific or specialized knowledge Federal rules (702(a)); facts (702(b)); application of principles and methods (702(c)); application of criteria, principles, methodology, and test methods (amended in Daubert, 2000 — (702(d)) before FTC Commissioner.
  • An advisor to value-based care companies, including Medicare Advantage and Medicare Shared Savings Accountable Care Organizations.
  • Led investor diligence on over $8 billion in healthcare merger and acquisition transactions.
  • Trained in clinician, coder, medical billing, claims, E.H.R, hospital and practice management software, and regulatory, usual, customary and reasonable (UCR) medical and prescription charges. Application of Inpatient Prospective Payment System (IPPS), Outpatient Prospective Payment
  • System (OPPS), and Medicare Physician Fee Schedules (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), and market reimbursement by health, auto, and liability payors.
  • Opinions on over $2 billion in medical reimbursements for inpatient facilities (inpatient prospective payment system or IPPS and DRGs, ICD-9) and ambulatory (non-facility using CPT codes).

Education

  • Harvard Medical School, Cambridge, MA —Bioethics: ethical, legal, technological, social issues in medicine including genetics and opioids / pain management —2018
  • Stanford Medical School, Palo Alto, CA — Studies in Biomedical Informatics1 master’s curriculum focusing on mobile and telehealth technology; admitted to special studies in 2013
  • University of Southern California, Marshall School of Business, LosAngeles, CA —
  • Bachelor of Science, Business Administration, 1981; studied in Entrepreneur Program focused on management, marketing, financing of startups (first of its kind in the U.S.)
  • University of California, Irvine — AB, Economics, Computer Science, Statistics, 1978

1 Technically, Granted in Part, Denied in part. See C.V. end note 2. Partial grant of motion was not due to expert qualifications but based on procedural issues and the Court’s determination of what was admissible.

Additional Course Work and Experience

  • U.S. Patent and Trademark Office roundtables focus on healthcare / medical: PTAB seminars re: Prior Art Access, Non-appealable issues / Petitionable Matters in Ex parte Appeals, Preparation of IPR petition, infringement and invalidity report as provided for in
    §42.65 Expert testimony; tests and data.
  • Massachusetts Institute of Technology, Cambridge, MA special studies: cybersecurity for electronic healthcare using blockchain, 2018-2019
  • Clinical documentation, medical coding, billing reimbursement, HIPAA transactions, value based care, and risk adjustment (see attachment 11 in this CV re: medical coding).
  • Villanova University – Lean Six Sigma and Process Improvement (2007)
  • Wharton School, University of Pennsylvania – Leadership Strategies (1982)
  • University of California, Irvine – Computer Science, Statistics, Economics (‘76-’78)
  • Ongoing management of team of physicians, healthcare IT experts, regulatory and policy experts formerly with CMS, and AAPC, AHIMA certified coders in our engagements with insurance, hospital, physician and other payors, providers, and IT companies, and electronic health record, patient safety and document authenticity advisories based on HIPAA, HITECH Act, and Joint Commission standards. Regular speaker and attendee at conferences, roundtables, and webinars on healthcare industry regulations, data, and economic issues.
  • Certified Ambulance Documentation Specialist (CADS) National Academy of Ambulance Compliance, May 2018; trained in medical coding and billing
  • Certified in HIPAA Concepts, Privacy and Security and EDI transactions, certified in HIPAA; medical coding and billing, course work in compliance officer curriculum (see addenda).

Programming languages education and knowledge

  • LISP
  • Fortran
  • Smalltalk virtual machines
  • interactive debuggers
  • compilers
  • Basic
  • Pascal software development
  • SQL database tools and statistical models for economics
  • PHP
  • Java
  • Ruby
  • CSS/HTML/responsive web technology for mobile health as well as content optimization for Google Search Engine Optimization.

Industry Awards and Recognition

  • 2016 Nominee: Best Legal Blogs of 2016 for healthcare industry sector

Publications

Lectures, Conference Speaking Engagement

  • Presentation to Assistant U.S. Attorney, FBI, and OIG in Cincinnati, Ohio (March 2018) regarding Meaningful Use of Electronic Health Records, demonstration of electronic health records and patient data including diagnosis codes, medical procedure codes, computerized provider order entry, drug-drug interactions, clinical decision support, physician progress notes in compliance with 45 CFR 170.304 (E.H.R. software certifications, physician and hospital attestations), and certifications and second standard §170.314.
  • Presentation to the Assistant U.S. Attorney, Southern District of New York (January 2018). Evaluation and Management (E&M) codes and appropriate usage based on complexity and severity of existing diagnosis codes rendered by physicians according to AMA guidelines.
  • Presentation to the Assistant U.S. Attorney in Houston, Texas (October 2017) regarding professional components and technical components of CPT coding for 95951— monitoring for localization of cerebral seizure focus by cable or radio, 16 or more channel telemetry, combined electroencephalographic (EEG) and video recording and interpretation (e.g., for presurgical localization); each 24 hours.
  • Presentation to the Assistant U.S. Attorney, FBI, and Office of the Inspector General (OIG) for HHS in Cincinnati, Ohio (November 2015) regarding Meaningful Use of Electronic Health Records in confidential qui tam false claims act investigation regarding 45 CFR 170.304 (E.H.R. software certifications, physician and hospital attestations), and certifications and second standard §170.314 electronic health record certifications—including electronic storage and display of patient progress notes, patient diagnosis, patient clinical quality measures, smoking status, problem lists, drug-drug interactions, allergies, and computerized provider order entry.
  • (2015, November 2015) Medical Device Reimbursement, FDA, 510(k) FCC, and CMS regulatory disruption and opportunities under the Affordable Care Act, ICD-10, and HITECH Act. BioMed Device and Wireless Device Conference, San Jose, California.
  • (2015, September 2015). Meaningful Use of Electronic Health Records, HIPAA Privacy and Security, and potential damages for breaches under the HITECH Act as a foundation for the International Classification of Diseases from the World Health Organization (ICD-10) — Discussion of risks and opportunities in these two regulations; discrete data, quality measures, medical codes: clinical documentation, clinical decision support, physician and patient engagement, HIPAA Privacy and Security, and revenue cycle. Wolters Kluwer Corporate event, presented to audience of over 1,800 participants.
  • Wolters Kluwer 2015 webcast to over 800 pharmacists, re: medical coding and billing and correlations with drug indications based on new ICD-10 diagnosis codes. Letter of recommendation received from Wolters Kluwer events staff available upon request.
  • (2015, January) JP Morgan Healthcare Conference, re: economic shifts due to changing standards in medical coding and billing. San Francisco, California
  •  (2014) HIPAA Plain and Simple/HIPAA for Behavioral Health — Credible Behavioral Health E.H.R. Software Users Conference, Baltimore Maryland
  • (18 March 2014) regarding 42 CFR Part 2 — privacy in behavioral health patient records, data segmentation requirements of The Substance Abuse and Mental Health Services Agency (SAMHSA) and the Health Resources and Services Administration (HRSA), which provides resources for Federally Qualified Health Centers (FQHCs). HITECH Act Information Safeguards, HIPAA Privacy Rule and HIPAA Security Rule, implementation of risk assessments by Covered Entities. HIPAA Omnibus Rule Overview, National Public Rule Making (NPRM) about privacy rights, and duties of Business Associates.
  • Diagnostic and Statistical Manual of Disorders (DSM 5) and the International Classification of Diseases, version 10 (ICD-10) with respect to changing medical coding and billing standards. Discussion of changes in number of, and use of, diagnosis codes for anxiety disorders, autism spectrum disorders, mood-related disorders, schizophrenia, and drug abuse. Challenges in obtaining data; value in objectivity of the data. CMS guidance regarding DSM IV vs. HIPAA Standard Transactions — Credible Behavioral Health E.H.R. Software Users Conference, Baltimore, Maryland (18 March 2014).
  • (2014) Managed Care and Accountable Care for Behavioral Health. Risk adjustment and capitated payments and the intersection with Behavioral Health. Discuss populations who fit into ACOs who: (1) have a high-risk score under CMS’ HCC risk adjustment model; (2) are considered high-cost due to having two or more hospitalizations each year; (3) are dually eligible for Medicare and Medicaid; National Association of State Mental Health Program Directors (NASMHPD) criteria §1115 (Statewide) Medicaid waiver using three separate ACO models. Seven more States were in the process of setting up their own Medicaid ACO programs, eligibility, and coverage determinations8 — Credible Behavioral Health E.H.R. Software Users Conference, Baltimore, Maryland (18 March 2014).
  • re: medical coding and billing webcast. HIMSS 2014, Orlando, FL.
  • (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). Discussion of healthcare data analytics methods, inpatient and outpatient procedure coding, comparison of record audit methods, and physician engagement strategies and audit results. Workgroup for Electronic Data Interchange (WEDI) National Conference, Washington D.C.
  • Duke Life Health System (2013), Pittsburgh, Pennsylvania — Physician engagement for accuracy of medical coding using clinical concepts, and clinical documentation improvement for ICD-10.
  • (2013, April 23). 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, HITECH Act Security and Meaningful Use, Best Practices Health IT, process improvement. Scripps Healthcare Summit 2013. Lecture conducted from La Jolla, San Diego, California.
  • (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.
  • American Health Information Management Association (AHIMA), re: medical coding and billing. 2013, New Orleans, Louisiana.
  • (2012, June 14). ICD-10: Impact on Payment Reform. Wisconsin Medical Society. Lecture conducted from Madison, Wisconsin.
  • (2012, May). How ICD-10 and Payment Reform Will Change the Radiology Revenue Cycle. Radiology Business Management Association (RBMA), Orlando, Florida.
  • (1994 – 1995). Impact of the Internet on medical and financial businesses, Loyola University, Los Angeles, California.
  • (1994 – 1995). Impact of the Internet on medical and financial businesses, University of California, Irvine, California.

Professional Affiliations

  • Medical Group Management Association (MGMA)
  • Health Information Management Systems Society (HIMSS)
  • American Academy of Professional Coders (AAPC)
  • American Health Information Management Association (AHIMA)
  • American Academy of Pain Medicine (AAPM)
  • Workgroup for Electronic Data Interchange (WEDI)
  • Association for Clinical Documentation Improvement Specialists (ACDIS)
  • California Ambulatory Surgery Association (CASA)
  • American Academy of Pain Medicine (AAPM)
  • American Society for Clinical Pathology (ASCP)
  • Information Systems Audit and Control Association (ISACA)
  • National Alliance of Medical Auditing Specialists (NAMAS) (February 2018)
  • Contributor: Strategic Financial Management Newsletter, Healthcare Financial Management Association;
  • Contributor: Healthcare IT News, GovHealth IT, Mobile Health News, Financial Health News
  • Volunteer: Children’s Hospital Medical innovation committee
  • Non-Litigation Consulting in Healthcare, Software, Financial Services
  • 2007 to Present -– 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.
  • Regulatory Consulting – 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 Center, Pittsburgh — ACO, ICD-10, Revenue Cycle Strategy; HCC risk adjustment for Medicare Advantage.
  • Evaluate over $1 billion in healthcare claims for risk adjustment, audit quality using RADV methods, and clinical documentation coding quality.
  • Evaluate Meaningful Use compliance risk with respect to storage and security of discrete data from medical records, data conversion strategies, and 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, Medicare Advantage, ACA, and ICD-10 regulations. Ambulatory, acute care – MU1, MU2, DSM-5, CPT, ICD-9, ICD-10, clinical documentation, HIPAA, Clinical Quality Measures, and CA Civil Code
      §56.
  • Nemours Children’s Hospital, Orlando, Florida — Meaningful Use of Electronic Health Records, HIPAA transactions for claims processing, and HIPAA secure clinical and physical plant data interoperability strategy of clinical and healthcare claims data using enterprise web services solutions.
  • Sharing of data in emergencies between clinical staff and security to protect pediatric patients.
  • Credible, Inc. a leading behavioral health electronic health record software vendor — Advised regarding compliance with HIPAA Privacy and
  • Security in general and specific 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 Health.

Regulatory Consulting – Health Plan, Self-Insured Employers

I lead a company that competed for, won, and led these among other account engagements where large global firms were also bidding on the business:

  • Walmart, top 5 employer globally — Advised regarding ERISA Plans, Taft-Hartley Trusts, Minimum Essential Coverage, HIPAA insurance claims transactions, CORE operating rules, ICD-10, and Affordable Care act business and regulatory issues, underlying systems, and process issues for the largest self-insured employer in the world.
  • National Home Health Care Efficiency and Electronic Records company —
  • Advised regarding revenue model, including home health resource groups (HHRGs), costs and technology adoption, regional adjustments, levels of clinical severity and supplies needs for home health and long-term care, Skilled Nursing Facility populations, and businesses to develop a new home health agency technology solution that manages labor efficiencies and deployments.
  • 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, and RAPS file analytics.
  • United Healthcare, Florida — Medicare Advantage HEDIS 5-Star Ratings, provider network clinical data, Utilization Management, Coordination of
  • Benefits, Case Management and claims processing using HCC and ICD-9 coding, RADV audit methods, and RAPS file analytics.
  • Public Employees Health Plan, Salt Lake City, Utah — Advised and assessed re: new 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 amounts, and other factors.
  • Regence BlueCross BlueShield, Seattle, Salt Lake, Portland — HITECH Act, HIPAA 5010, ICD-10 processes, DRGs, Ambulatory claims, Ancillary Services, and IT architecture to enable these capabilities which impacts medical policy plan design, actuarial processes, covered amounts, utilization management, eligibility, referrals, covered amount calculations.
  • TennCare – Tennessee Medicaid and TN Insurance Exchange eligibility
  • Citra Health Solutions, Jacksonville FL — Advisor to CEO. Advised leadership regarding value-based care, HIPAA privacy and security, meaningful use, and 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.
  • Alliance Family of Companies — Advised regarding regulatory compliance for EEG telehealth and EKG medical coding and billing, payor reimbursement, fair market value of medical directors using MGMA guidelines, professional fee and technical fee components of medical billing,
  • Medicare Administrative Contractor, and private payor coverage determinations.
  • Investor Diligence — $8 billion in Health IT M&A transactions
  • Selected as advisor regarding 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, and Sun Microsystems on largest cloud healthcare investment in Medicare Advantage and Accountable Care population health management and analytics.
  • NY PE Firm – Liability insurer and compliance with Medicare Medicaid SCHIP Extension Act of 2007 (MMSEA) reporting as provided for in Section 111.
  • 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.
  • In-Network and Out of Network medical charges, 340B Drug discount provider.

Medical Device, Pharmaceutical Regulatory Compliance

  • Abbott Labs, Medical Optics Div. (formerly Advanced Medical Optics) — Regulatory Affairs, FDA Compliance — led global complaint handling rollout (US, UK, EU, Asia) of pharmacovigilance solution supporting FDA Adverse Event reporting rules to FDA Adverse Event Reporting System
  • (FAERS), National Drug Codes (NDCs), HCPCS, formularies, and health insurance coverage determinations for pharmaceuticals. Consultant to Optics division on global FDA Adverse Event reporting system and pharmacovigilance system for medical devices and pharmaceuticals.
  • Led hardware and software development team through IQ/OQ/PQ process (IQ stands for Installation Qualification. OQ is Operational Qualification and PQ is Performance Qualification for FDA approval for medical device.

Prior Experience, Non-Litigation Consulting Work

  • October 2002 to February 2007 — First American/CoreLogic — SVP eCommerce — Banking solutions for $8 billion firm. Led one of the largest, most complex Sarbanes Oxley IT audits in the U.S., according to attorneys and accounting firm. Led rollout of single platform eCommerce solution to integrate Wells Fargo, JP Morgan Chase, Bank of America, and other transactions for mortgage loan origination (credit, valuation, tax, flood, title, etc.), closing, and securitization.
  • 2002 to October 2003 — Fidelity — SVP eCommerce — Banking solutions, $12 billion firm
  • May 2000 to 2002 — Citrix Systems — President & CEO (Erogo, a SaaS Cloud medical and internet billing company). Built cloud SaaS internet medical billing company from $500k to $10 million in revenue and investment by Citrix.
  • June 1997 to October 1999 to 2000 Axway/Worldtalk, Silicon Valley — VP Marketing for a secure email and Cloud/Internet of Things (IoT) rules-based interoperability company.
  • June 1997 to October 1999 — Heidrick & Struggles, Silicon Valley — President & CEO, LeadersOnline — Hired by premier executive search firm to build and lead an online recruiting business to diversify and assist with IPO. Set strategy, acquired assets, and led launch of Internet recruiting business as portion of IPO prospectus (S-1) and road show with Goldman Sachs, adding $100 million to market cap of Heidrick at IPO.
  • September 1981–May 1997 — Smith Tool, Oracle, HP, Symantec, Intel, ParcPlace — Served as management consultant to Hewlett Packard on their web services strategy for enterprise clients; developed internet content joint venture partnerships between Oracle and media
    companies; led IP licensing strategy and partnerships between Symantec and Intel (online software distribution), derivative works negotiations; assisted attorneys in software knowledge domain; served as Vice President of Marketing and Channel Sales for an object-oriented software development tool company; built team and helped grow company to a $50 million acquisition.
  • Cincom Systems, Borland, Ashton-Tate — Silicon Valley, Southern California, Boston — roles from Product Manager, VP Marketing and Channel Sales, and Corporate Development. Built a company from $2 million to $50 million buyout, owner of $350 million P&L and brand relaunch, turnaround.

Supplemental Attachments Available Upon Request

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