Our team led the implementation of a global complaint handling system that integrates with SAP CRM in compliance with the FDA Adverse Event Reporting System (FAERS) requirements provided for in 21 CFR 310.305, 314.80, 314.98, 600.80 for the pharmaceuticals product lines. Adverse events and medication errors are coded using terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology for this medical device and pharmaceutical company. Led the implementation of a solution for the medical device and pharmaceutical divisions; a pharmacovigilance complaint handling system which was implemented to comply with FDA Adverse Event Reporting requirements such as Corrective Action, Preventative Action or CAPA as provided for in 21 CFR 820.90 nonconforming product; 21 CFR 829.100 Corrective Action, Preventative Action; 21 CFR 820.198 complaint files.
Usual customary and reasonable charges for medical billing; medical bill review, medical coding review. Consider medical opinions regarding causation and evaluate Usual Customary and Reasonable Charges net of medical bills associated with an incident
Confidential Plaintiff: HIPAA Privacy Breach, Improper Infectious Disease Reporting
Served as HIPAA Privacy Expert regarding what may be reported to County Public Health Authorities, State Public Health Authorities, and to Federal Health Authorities such as the Centers for Disease Prevention and Control (CDC); what data would be necessary to disclose to co-workers, what if any data may be disclosed to the public / press; the HIPAA de-identification Standard; what Protected Health Information (PHI) may be disclosed for the purposes, hypothetically to epidemiologists working with a health authority for contact tracing. Whether a hospital met Standards regarding reporting of infectious disease, HITECH Act Standards; HIPAA Privacy Standards
Evaluate HITECH Act Administrative Safeguards, Physical Safeguards, Technical Safeguards, Policies and Procedures including Electronic Health Record implementation, policies and procedures as required under HIPAA Privacy Rule and HIPAA Security Rule.
Confidential Fortune 100 Publicly Traded Company
Led implementation of Sarbanes Oxley Section 404 compliance. The Sarbanes-Oxley Act requires that the management of public companies assess the effectiveness of the internal control of issuers for financial reporting. Section 404(b) requires a publicly-held company's auditor to attest to, and report on, management's assessment of its internal controls
Confidential Class Action
Expert witness litigation consulting pertaining to HIPAA transaction standards and code sets, damages under the Medicare Secondary Payer Act (MSPA), Non-Group Health Plans (NGHPs), Responsible Reporting Entities (RREs), Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) mandatory data Standards and processes to query CMS data, systems, Business Associates under HIPAA, Reporting Triggers, Ongoing Responsibility for Medicals (ORM), Total Payment Obligation to Claimant (TPOC),
Assist public employees health plan in the transition to the International Classification of Diseases release 10 (ICD-10) developed by the World Health Organization and adopted and modified by the U.S. Health and Human Services Department Centers for Medicare and Medicaid (CMS) as ICD-10-CM
Led hospital system in transition from ICD-9 to ICD-10-CM diagnosis coding system; evaluated all aspects of transition and guided internal team on project governance, clinician engagement, claim data analytics, chart reviews, actuarial, coding, payer contracting, Health Information Management (HIM) engagement, IT systems including electronic health record implementation with respect to discrete data to support medical documentation and medical coding specificity.
Confidential Physician and Seller of Healthcare Practice
Served as medical coding expert and medical billing expert witness; served as damages expert. Applied Standards pertaining to clinical documentation and coding; evaluated payor contracting and claims reimbursement in dispute regarding buyer and seller of medical practice.
U.S. Department of Justice; Confidential litigation consulting engagement pertaining to the False Claims Act, HITECH Act, Meaningful Use of Electronic Health Records. $155 million settlement. Standards included electronic prescribing Standards"enable prescriber to send and receive the specified prescription transactions electronically per the NCPDP SCRIPT Standard Implementation Guide Version 2017071 and using RxNorm vocabulary codes... pursuant to 45 CFR 170.555(b)(2); and data integrity Standards provided for by HIPAA and the HITECH Act.
Top 20 Philanthropic Foundation
Our firm performed research for global, regional and national level initiatives and achievements with an emphasis on the African continent.
Led hospital engagement regarding the International Classification of Diseases version 10 (ICD-10) diagnosis coding transition plan for a regional hospital in Pennsylvania. Scope included clinical documentation assessment using analytics and chart audits, physician engagement, training, payer contracting, actuarial guidance, Electronic Health Record implementation with respect to ICD-10 and Meaningful Use of Electronic Health Records Standards
Confidential Criminal Defendant - Litigation Consulting
Litigation consulting engagement. Evaluate prosecutions' methodology to prosecute alleged Medicare fraud, Tri-Care fraud. Evaluate Medicare Local Coverage determinations, active Medicare LCDs and retired Medicare LCDs, Medicare Administrative Contractor (MAC) jurisdictions, patient documentation, patient conditions pertaining to local coverage determinations. Perform claim data analytics, develop statistical sample size methodology, evaluate methods of extrapolation for statistical validity, develop damages model.
Confidential Relator (Whistleblower)
Qui Tam False Claims Act Litigation and California False Claims Act - Litigation Consulting
Serve as medical billing expert witness. Serve as Medicare fraud damages expert witness. Evaluate hospital cost reports, patient documentation, ambulance billing, psychiatric coding and behavioral health billing Standards
Confidential Plaintiff - HIPAA Privacy Breach
Serve as HIPAA Security Rule and HIPAA Privacy Rule expert; HIPAA Expert Witness regarding applicable Standards and whether a HIPAA Covered Entity met applicable Standards regarding implementation of its Electronic Health Record and security policies and procedures, management, training and oversight of clinical support staff pertaining to Safeguards provided for in the HITECH Act and HIPAA; HIPAA Omnibus Rule Standards pertaining to Business Associates.
Confidential Defendant and Medical Provider in Trade Secret and Intellectual Property Dispute
Served as experts regarding Uniform Trade Secrets Act and state Uniform Trade Secrets Act; evaluated alleged intellectual property, superbills, medical coding diagnosis code sequences and medical procedure code sequences; considered whether alleged Intellectual Property was Novel, Unique or Non-Obvious; (The United States Patent Office (USPTO) grants patents to inventions that meet three main criteria. The invention must be novel, nonobvious, and useful. To be novel, an invention must be substantially different from anything else that is public knowledge.) Performed research using the PICO Framework for evidence based medicine, prior art; guidance to client regarding 'PHOSITA' (A patent cannot issue on an invention that would have been obvious to a “person having ordinary skill in the art” (a “PHOSITA”))
Assisted with implementation of updates to Trizetto FACETS claims system using process modeling tools and Subject Matter Expert (SME) to design processes including verification of benefits / eligibility checks, prior authorizations and explanation of benefits (EOB) workflows
Confidential Pain Management Physician - Criminal Defendant re: Alleged Violations of Drug Diversion Provisions of the Controlled Substances Act
Retained by pain management physician's counsel who was raided by the Drug Enforcement Agency for alleged violations of the Controlled Substances Act. The physician was a large prescriber of Schedule II pharmaceuticals, Opioids such as Oxycontin. The Government chose to audit a tiny fraction of the physicians' records and concluded that the physician should be barred for life from practicing medicine. We examined peer physicians' prescribing patterns in the State jurisdiction and compared them to the defendant physician's. We used a Standard protocol including, but not limited to: a) We audited a much large statistically valid sample size, b) created month's supply calculations, c) examined Morphine Medication Equivalents (MMEs), examined state Prescription Drug Monitoring Program (PDPM) data, inventory control, documentation standards, pain management agreements, toxicology results and other factors to ascertain whether patients were receiving medically necessary prescriptions or had drug-seeking behavior. Result: the physician kept his license to practice medicine.
Confidential Compounding Pharmacy
Evaluate Drug NDC codes and compound unfinished codes, advise regarding data standards, extract, transform and load (ETL) of data, data quality assessment, develop data analytics approach for damages model.
Perform acquisition diligence ("M&A diligence") for premier venture capital firm regarding candidate portfolio investment in the Accountable Care market; evaluate medical coding and medical billing, regulatory risk, capitated plan / risk adjustment under Medicare Part C / medicare advantage, and analytics offerings.
Confidential Personal Injury Plaintiff
Evaluate medical billing and medical coding, Medicare Part C / Medicare Advantage capitation rates, medical billing on lien basis. Analysis of medical provider bills. Serve as Medical Billing Expert witness and orthopedic medical billing expert witness regarding Usual Customary and Reasonable (UCR) charges in the community without considering a collateral source rule. Analysis of charges of providers in the community including hospitals, ambulatory surgical centers (including ASC facility fees and revenue codes), orthopedic surgeons including CPT coding and CPT code modifiers, physical therapy, radiology including MRI and x-ray charges, anesthesia, pain injections, Durable Medical Equipment (DME) charges
Confidential Personal Injury Plaintiff
Served as an expert regarding electronic health record clinical decision support, drug-drug interaction alerts, documentation standards, EMTALA Standards. The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law that requires anyone coming to an emergency department to be stabilized and treated, regardless of their insurance status or ability to pay. Considered whether Defendant met Standards such as Joint Commission National Patient Safety Goals (e.g., Use at least two ways to identify patients. For example, use the patient’s name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment. etc.)
Medical billing expert witness; evaluate usual customary and reasonable charges, medical coding review, medical bill review. Provide analysis of customary charges in the community.
Advise health plan client and HIPAA Covered Entity regarding the transition to the new electronic data interchange Standard known as HIPAA 5010. Evaluate companion guides, EDI claim data (e.g. ASC X12N 837 - Health Care Claim: Professional, and Addenda to Health Care Claim: Professional, as referenced in § 162.1102 and § 162.1802., testing implementation. Evaluate claims system architecture.
Evaluate usual customary and reasonable historical charges and the reasonable charges for future medicare; evaluate opinions of life care planner.
Adise hospital system regarding usual customary and reasonable charges in the community; usual customary and reasonable charges for proposed future life care plan including physical therapy, home health care; consider Standards such as the Affordable Care Act, Medicaid Expansion, Americans with Disabilities Act
Genetic testing Standards for CPT codes and test panels, analytics of Medicaid Claim Data
Governent Agencies, Health Plan, Hospital, Medical Device, Pharmaceutical, Self-Insured Employers, Law Firms, Intellectual Property and Trade Secret owners, and Investors Litigation consulting to plaintiffs, Relators, Class Actions, Defendants who may be patients, injured parties, health plans or health care providers
Representative list of clients include health plans,hospital systems, physician groups, and ambulatory surgical centers, Independent Diagnostic Testing Facilities (IDTFs) radiology centers, laboratories, dialysis centers, reference laboratories and others. Our litigation consulting work includes retention by Federal and State agencies, plaintiffs, and both civil and criminal defendants. Our team has worked in several areas including ICD-10, Meaningful Use of Electronic Health Records, Accountable Care Organizations, Affordable Care Act value of future care,, orthopedic injury medical coding and economics, clinical documentation improvement, the HIPAA Privacy Rule, the HIPAA Security Rule, Hospital Safety policies and procedures prescribed by the Joint Commission, ePrescribing, Health Insurance Exchanges, Health Information Exchanges (HIE) Investor Diligence for venture capital firms, private equity firms, and vendor evaluations of Healthcare IT firms.