If you are having a difficult time navigating through the Medicare Part D Coverage Gap Discount Program (CGDP) lifecycle timeline, you’re not alone. The CGDP has been a cause of concern for pharmaceutical companies in the United States ever since it was included in the Affordable Care Act (ACA) to reduce the costs of prescription drugs for beneficiaries in the coverage gap. With the CGDP, manufacturers are required to provide 50% discounts on eligible brand-name drugs for qualifying Medicare Part D beneficiaries who have reached their coverage limit, but have not yet reached the catastrophic limit, after which such drugs would be covered again.
While this program stands to relieve the burden for many vulnerable patients, there are still quite a few concerns about how it has been implemented. In particular, pharma manufacturers are largely concerned about: the stringent CGDP deadlines, the CGDP pay and chase dispute process, the lack of data to properly evaluate invoices for dispute, knowing when they should pursue a dispute and the lengthy dispute lifecycle timeline. Fortunately, there are experts waiting to help navigate you through this lifecycle. For now, consider these four basic phases that you need to know and prepare for in the CGDP lifecycle timeline.
Preparing for Invoice Processing
Let’s say the last day of the quarter for the PDE invoice period is December 31, this is approximately 30 days before the quarterly invoice distribution on January 31. During these 30 days manufacturers should begin their preparation for the upcoming 4Q14 invoice processing phase.
During this phase manufacturers should complete the following preparation activities:
1. Manufacturers & Plan Sponsors should submit any account or banking information updates to the TPA by the Qtrly EFT file cutoff date, the cutoff tends to be around 20 days before the Qtrly Invoice Distribution
This will help to ensure electronic funds are transferred to the bank accounts as applicable for positive and negative invoice payments.
2. The TPA distributes the updated Manufacturer and Plan Sponsor EFT files approximately 5 days before the Qtrly Invoice Distribution.
The Manufacturer must review the Plan Sponsor EFT files for any new Plan Sponsors or changes to the Plan Sponsors account or banking information and make any changes in their ERP system prior to rocessing invoice payments for the upcoming invoice processing phase.
Processing Invoices & Tracking Negative Payments
After the preparation phase is complete, there’s the invoice processing and negative payment tracking phase. This begins once the Quarterly invoices are distributed. Approximately 30 days after the end of the applicable quarter’s PDE invoice period, the TPA will send out quarterly invoices to the manufacturer’s File Transfer Protocol (FTP) sites. Quarterly invoice payments will then be due 38 days after the receipt of invoice. During this 38 day timeframe, Manufacturers should be receiving funds from Plan Sponsors for any negative invoices for the quarter. The Manufacturer will need to track receipt of funds for any negative invoices identified on the applicable quarter’s invoice reports. Manufacturers must then send payment confirmation reports to the TPA within five business days following the 38 day payment deadline. In addition to confirming payment to Plan Sponsors for positive quarterly invoices, the payment confirmation reports must also include confirmation of receipt or non-receipt of funds for negative invoice payments. During this phase manufacturers should also begin reviewing and validating the detail data for potential disputes.
Submitting & Resolving Disputes & Appeals
If you are considering pursuing a CGDP invoice dispute one of the most important things you need to be aware of in the CGDP dispute submission and resolution phase is the dispute submission deadline. When manufacturers identify disputes for any of the coverage gap discount payments that they have made to Part D Plan Sponsors through this program, they have 60 days from the quarterly invoice receipt date to submit those disputes to the TPA The quarterly invoice receipt date begins the countdown for all following CGDP deadlines for the cycle: payment deadline, negative invoice payment deadline, payment confirmation deadline, dispute deadlines, and appeal deadlines. For example if the 4Q14 invoice is received on February 2 disputes for these invoice payments will need to be submitted to the TPA no later than 60 days after the receipt of the invoice or April 2.
Following the dispute submission deadline are the timelines associated with the dispute resolution and appeal phases, which can span upwards of 210 days collectively. The TPA, or the Centers for Medicare and Medicaid Services (CMS), for the 4Q14 invoice period, has until June 1, 60 days from the dispute submission deadline to respond to the dispute. If this deadline isn’t met or if the dispute is denied, manufacturers can then file an appeal by July 1, 2015, 30 days from the dispute resolution deadline to the Independent Review Entity (IRE), which has until September 29, 2015, 90 days from the appeals submission deadline to come to a decision on the appeal. If the IRE denies the appeal, the manufacturer can file an administrative appeal to CMS by October 29, 2015, no later than 30 days after the original appeal resolution date. The Administrator’s decision is final and binding.
Clearly, there are many deadlines to track within the CGDP invoice and dispute lifecycle timeline. Are you still concerned or unclear about the intricacies of the CGDP invoice and dispute process timeline and what is required for each deadline? You’re not alone - now is the time to take the next steps and get the information or support you need to understand this process and exactly what it means for your business.