Aaron Vandervelde Managing Director Berkeley Research Group

Transcription

1 Aaron Vandervelde Managing Director Berkeley Research Group

2 Statement re Interests Aaron Vandervelde provides services as an independent consultant concerning 340B matters to pharmaceutical manufacturers and various trade organizations that represent pharmaceutical manufacturers. 2

3 Today s Agenda Why are manufacturers focused on monitoring covered entities compliance in the 340B program? Approaches to monitoring for duplicate discount compliance Resolution process (State Medicaid agencies vs. covered entities) Case Study 3

4 CE Question Which of the following approaches are manufacturers using to monitor compliance with duplicate discount prohibition? A) Evaluating percentage of total sales at a 340B price B) Monitoring the HRSA audit results and conducting independent analysis of potential duplicate discounts C) Analyzing state claims level detail files and comparing with Medicaid Exclusion File D) All of the Above 4

5 Why manufacturer oversight of covered entity compliance? Financial burden of non compliance with GPO prohibition, diversion & duplicate discounts is borne by manufacturers Manufacturers have access to certain data that provides insight into potential non compliance that covered entities do not have State Medicaid rebate requests Metrics for all covered entities (specific to a manufacturers own products) that allow for benchmarking Recent language from state Medicaid programs places increased urgency on addressing historical duplicate discounts Recommendation that manufacturers only be able to recover duplicate discounts that occurred in the prior three years HRSA audit results and recent covered entity disclosures indicate that there is a significant amount of non compliance in the 340B program 5

6 Approaches to monitoring duplicate discount compliance State Medicaid claims data scrubbing for covered entities that are listed on the Medicaid Exclusion File This approach needs to account for how a specific state utilizes the Medicaid Exclusion File in carving out 340B utilization Analysis of percentage of total purchases made at a 340B price for covered entities not listed on the Medicaid Exclusion File Chargebacks to Sales Ratio Immunology Actual Ratio Expected Ratio % of Medicaid Patients Chargebacks Sales Percentile % 64% 35.9% 14,419 15, % % 63% 36.8% 14,974 15, % % 63% 36.8% 11,810 11, % 6

7 Approaches to monitoring duplicate discount compliance Monitoring Medicaid Exclusion File for newly listed Medicaid Provider Numbers (MPN) or National Provider Identifiers (NPI) A newly listed MPN/NPI could represent an historical omission on the part of the covered entity Additional analysis of chargeback trends and state Medicaid claims level detail files can provide additional insight into the likelihood of historical duplicate discounts associated with the newly listed MPN/NPI Reviewing HRSA audit results with adverse findings related to duplicate discounts and covered entity self disclosures of duplicate discounts Assess whether repayments: Encompass an appropriate time period Include all drugs made available at 340B prices Cover both Medicaid Fee for Service (FFS) and managed Medicaid patients Properly calculate the repayment amount 7

8 Resolution Process Manufacturers can be made whole for duplicate discounts in two ways: State Medicaid agency refunds the Medicaid rebate through the dispute resolution process 340B covered entity repays the difference between WAC and the 340B price HRSA prefers that manufacturers resolve issues of duplicate discounts directly with the state Medicaid agencies or covered entities and keep them informed as to the process and outcome However, it is unclear whether manufacturers should start with covered entities or state Medicaid agencies or whether the root cause of the duplicate discount should somehow inform whether to pursue refunds from the state Medicaid agency or covered entity 8

9 Case Study Duplicate Discounts Through analysis of state Medicaid claims level detail files, a manufacturer identified Medicaid rebates for a Medicaid Provider Number listed on the Medicaid Exclusion File Additional analysis of chargebacks and sales data determined that the covered entity purchased almost 100% of the product at a 340B price Manufacturer initiated the dispute resolution process with the state Medicaid agency under the belief that the Medicaid rebates should have been carved out due to 340B utilization However, the state Medicaid agency indicated that they do not rely on the Medicaid Exclusion File for physician administered drugs and instead require 340B covered entities to include a UD modifier on the claim and bill the state at actual acquisition cost This covered entity had failed to list the UD modifier but had billed actual acquisition cost Even though the state benefited from both the AAC and the Medicaid rebate, they are requiring the covered entity to rebill with the UD modifier before taking any action 9

10 CE Question Which of the following approaches are manufacturers using to monitor compliance with duplicate discount prohibition? A) Evaluating percentage of total sales at a 340B price B) Monitoring the HRSA audit results and conducting independent analysis of potential duplicate discounts C) Analyzing state claims level detail files and comparing with Medicaid Exclusion File D) All of the Above 10

11 CE Question & Answer Which of the following approaches are manufacturers using to monitor compliance with duplicate discount prohibition? A) Evaluating percentage of total sales at a 340B price B) Monitoring the HRSA audit results and conducting independent analysis of potential duplicate discounts C) Analyzing state claims level detail files and comparing with Medicaid Exclusion File D) All of the Above 11

12 Additional Questions? Aaron Vandervelde Managing Director Berkeley Research Group, LLC Phone: