The Patented Medicine Prices Review Board is seeking stakeholder comments on proposed changes to its Compendium of Policies, Guidelines and Procedures related to thresholds for opening an investigation and offsetting de minimus excess revenues.
With respect to thresholds for opening an investigation, the Board is proposing to eliminate the 5% investigation trigger at the national level for existing drug products. The present criterion for commencing an investigation for existing drug products when the National Average Transaction Price exceeds the Non-Excessive Average Price by 5% will trigger a high number of investigations with cumulative excess revenues that are less than $50,000. It is believed that the avoidance of investigations involving amounts of excess revenue less than $50,000 will result in a more efficient use of the Board's resources.
For offsetting de minimus excess revenues (i.e., an amount that does not trigger the investigation criteria), the Board proposes that the 3-year period that is presently allowed to offset such revenues through a Voluntary Compliance Undertaking be replaced by a requirement to offset in a timely manner. Investigations are not triggered for drug products with a de minimus excess revenue balance. In the absence of a VCU, the only current option is to proceed to a public hearing, which has led to delays in collecting de minimus excess revenues. It is the Board's belief that it would be more efficient if patentees are required to offset excess revenues less than the de minimus amount in a timely manner.
The deadline for providing feedback on these proposed changes is May 14, 2012.