Overview
- HHS OIG Advisory Opinion No. 25-11 issued a favorable view of a vaccine manufacturer's multi-vaccine discounts and declined to impose sanctions.
- Upfront percentage reductions, including contingent upfront discounts tied to prior purchase thresholds, qualify for the discount safe harbor when the price cut is known and applied at sale.
- Bundled upfront discounts and bundled rebates with adjustable terms do not meet the safe harbor definitions, yet OIG deemed the arrangements low risk under the specific safeguards presented.
- OIG cited attribution of discounts to each separately billable item, equal benefit across Medicare Part B and Part D, discounts applied to each vaccine in the bundle, and the availability of competing products with similar list prices.
- The manufacturer met seller obligations by providing written terms, notifying buyers of reporting duties, issuing periodic accounting, and complying with price reporting requirements, with the opinion limited to the facts presented.