Matters
- Represented 340B Covered Entities in matters against drug manufacturers to successfully obtain access to limited distribution drugs at the 340B ceiling price, and represented 340B Covered Entities in their pursuit of refunds from manufacturers that previously charged prices that exceeded the statutory 340B ceiling price
- Advised several academic medical centers on telehealth matters for COVID and post-COVID operations, including an analysis of state and federal controlled substance rules and registration requirements for multi-state operations
- Assisted accountable care organization entity with development of strategic 340B model
- Represented Section 318 clinic in litigation related to 340B drug pricing agreements
- Assisted 340B Covered Entity with regulatory considerations when developing transplant outreach sites
- Assisted with development of new hospital cancer center participating in the 340B program including assistance with definitive documents related to partnership with local oncology group
- Assisted academic medical center with the development of an in-house specialty pharmacy
- Successfully represented several 340B Covered Entities during Office of Pharmacy Affairs 340B audits and mitigated audit findings; prepared and implemented OPA-approved Corrective Action Plans and assisted Covered Entities with manufacturer repayments
- Performed independent 340B audit readiness reviews of a number of 340B Covered Entities and developed internal Corrective Action Plans
- Defended hospital in whistleblower false claims act action related to 340B matters
