Overview
Bates White provides empirical analysis and research in support of external medical, epidemiological, and regulatory (e.g., CMS, FDA) experts, which often complements our economic expert analysis. For example, we have researched CMS coverage and reimbursement policies and analyzed statutory reimbursement rate trends in support of regulatory experts, and we have evaluated clinical care patterns observed in patient medical records and modeled but-for clinical trial outcomes based on alternative clinical endpoints in support of medical experts. This work often requires digitizing and extracting key data points from large volumes of documents and non-standard information sources to create usable data.
Selected Work
- Supported CMS regulatory expert’s analyses on behalf of a device manufacturer facing allegations that its online tools violated the Anti-Kickback Statute and the False Claims Act (FCA). Described how CMS coverage and reimbursement rules and the medical literature on the relationship between provider experience and clinical outcomes were consistent with defendant’s operation of its online tools.
- Supported FDA regulatory expert’s analyses in Himawan et al. v. Cephalon et al., in which Cephalon was alleged to have failed to fulfill its contractual obligations to exercise commercially reasonable efforts to develop a novel biologic medication. Described challenging regulatory pathway to approval and produced novel analyses of clinical trial results based on data extracted from study exhibits in order to compare the at-issue drug’s probability of success and commercial viability to that of other pipeline products.
- Provided consulting support to counsel for an academic researcher facing allegations that he misrepresented the results of pre-clinical laboratory studies of novel analgesic drug compounds to an investor by performing a retrospective analysis of the reliability of the studies’ statistical methods.
- Supported leading medical expert in preparing an expert report on behalf of a large medical care provider alleged to have violated the FCA by failing to comply with Medicare guidance regarding laboratory testing frequency. Summarized medical literature on the relationship between testing frequency and outbreaks and analyzed patient-specific clinical factors that influenced testing frequency based on synthesis of hundreds of thousands of pages of patient medical records.
- Supporting medical and FDA regulatory expert’s analyses on behalf of a pharmaceutical company alleged to have provided kickbacks to providers in the form of free business advisory services in violation of the AKS and FCA. Analyzing factors considered by prescribers including at-issue drug’s efficacy based on clinical trial data and medical literature.
- Supported DEA expert, medical, and health policy experts on behalf of Allergan in In re National Prescription Opiate Litigation and related litigation. In support of DEA expert, analyzed DEA ARCOS data and manufacturer sales and charge-back data to assess downstream sales to pharmacies. In support of medical expert, analyzed insurer claims data to prepare patient medical histories for review. In support of health policy expert, analyzed formulary coverage and utilization restrictions for at-issue products.
- Provided data analytics, cost-benefit analyses, and meta-analysis of healthcare literature on behalf of a medical device manufacturer in support of its interactions with FDA regarding the performance of a product and potential expansion of the product’s approved indications.
- In response to changes to the regulatory requirements for reporting prices to Texas Medicaid’s Vendor Drug Program, collaborated with compliance attorneys to develop price-calculation algorithms for a generic manufacturer.