Recently, my company purchased and re-labeled a product with a market date of 2002. We began selling it in March of this year.
As required, I added the appropriate product data on the new product to DDR. I was impressed that DDR allowed entry of the Base AMP in the proper base AMP quarter of 2002 even though it warned it was beyond the 12 quarter restatement period. Unfortunately, as soon as the product was updated, DDR displayed the message “labeler out of compliance” for the Monthly AMP periods of January and February 2007 for that labeler code. The “Drugs Missing Pricing” Report showed the new re-labeled product missing pricing. Shortly thereafter I received a response from CMS advising that I was out of compliance for not having submitted a complete monthly submission for January or February.
Apparently, the Market Date Field caused the technical problem. Since the system was reading a product that had a market date from 2002, it was expecting to find information for every period since the base AMP quarter. If you have any acquired re-labeled products you probably already noticed that the quarterly “Drugs Missing Pricing” report contains many of them. We’re dedicated to compliance and submitting information in a timely fashion at my organization, so naturally I was quite worried and a bit perplexed at first.
I continued to correspond with CMS and eventually received a response from Operations. They informed me that they were aware of the glitch in their system, and that they were working toward a solution. Operations advised that it was considering adding a field for Product Purchase Date that would solve this problem.
I wanted to offer this piece of news to the GP community, in case there were others who had experienced similar issues—CMS is aware of the potential problem and is addressing it. As a footnote, if you have an extensive catalog of acquired re-labeled products as we do, hopefully CMS will be able to populate the field with the old Accretion Date from MDRI so it won’t require updating literally hundreds of products with the Product Purchase Date when the field becomes available.