Thursday, February 14, 2008
Alphabet Soup: CMS talks DDR Ops for MDRP at the IIR DRA Conference in Baltimore
By Chris Cobourn, CIS GP Practice Lead
If you followed the acronyms in the title of this Blog article then congratulations, you truly are in the ranks of GP Geeks (and yes, that is a good thing!). We have to get badges, or at least some ID cards or something. Steve is actually working on a GP Geek Test for IIR in September, but that is a Blog article for another day.
On to the topic of today...
Last week, CMS held a very informative session at the IIR DRA conference in Baltimore regarding operational aspects of the new DDR system. As referenced in our post on February 5th, they also handed out a draft version of the Medicaid Drug Rebate Data Guide for Labelers.
I took some unofficial notes during the session which I would like to share with those Blog readers who may not have been able to attend. Meredith, CIS’ resident lawyer, tells me that I must state that these are unofficial notes, and I am certainly not trying to capture the exact content of the session, or to represent CMS in any way – does that officially qualify as paraphrasing? (Let me know, Meredith)
The topics varied during a very interactive Q&A session, then CMS revealed their thoughts on possible future functionality. I note things below in the order they were discussed, and in response to questions from the audience…
• Discussion about the Draft Medicaid Drug Rebate Data Guide for Labelers document:
It was made clear that the document distributed was considered an early draft. There is no specific timetable for it to be completed and posted on the Website, but it will be posted once they are 508 compliant. There was also discussion, which I found interesting, regarding how this document was different from the now obsolete Operations Manual. As you may remember, the Ops Manual is a fairly large document; however, the new draft document is far more streamlined and succinct. CMS explained that they are removing the policy level aspects of the old manual to make the new manual more operational and user-friendly. They are trying to create a better living document.
• Changes in the Technical Contact:
If you have to make a change to your technical contact in DDR, you will have to reactivate the related assigned designees in DDR. Their user IDs will remain in the system, but they will have to be reactivated.
• The Save button triggers certification:
This is a functional aspect of the system itself, and CMS would like to update it at some point to allow users to continue to the next screen without a save. For now, CMS recommends using the ‘Back’ button in order to avoid certification trigger.
• The relationship between DDR and MDR:
The core tables of the old MDR database have not become obsolete. MDR is still the primary system used by CMS to calculate URAs and process data to the states. DDR is an interface used by manufacturers, and it interfaces nightly to MDR with updates. MDR is also CMS’ analytical tool to evaluate submitted data.
• Out of Compliance Messages:
An “out of compliance” message may be presented as a response to specific missing data elements. The out of compliance message may not mean that you are actually out of compliance. The message may be triggered by the system, based upon whether specific required data fields are completed. There may be a difference between what you truly do have as missing data elements and what the system identifies as missing data fields. Recognizing this, you may need to evaluate the differences between what data is truly missing and what may be identified as missing data elements in the new system.
• Retroactive submission of termination date:
Manufacturers may encounter a situation where they are required to move the market date for products in the DDR system. This may be related to errors in the updates. An example would be a market date of 2000, and the manufacturer has 2000 data. The manufacturer then moves the market date to 2003. CMS is developing more analytical ability, and they are attempting to alert manufacturers of conflicts such as this.
• Export capabilities:
CMS indicated that download functionality is coming and encouraged discussion from the audience regarding format and layout. Manufacturers expressed the desire to download information primarily for the purpose of comparing what was in DDR to their systems. CMS agreed that this was a good objective but also wanted to clarify that they were not in the business of housing data.
• URA updated once a quarter:
The information that is posted to DDR is the same information that goes out to the states. It gets updated on a quarterly cycle. So if you update AMP and BP data, you may notice that your calculated URA does not match until the system is updated on the next cycle. CMS also encouraged manufacturers to communicate with them via the Operations email mailbox with any questions on how URA is calculated.
• Technical Contacts Communication:
Although the procedure is predominantly paper-based right now because of the system and volume, CMS hopes that it will become fully automated in the future
• Do not send Sensitive Data via Fax and Email:
For security purposes, manufacturers should not send sensitive information, such as Social Security Numbers or personal information, via fax or email.
• Uploading multiple files:
CMS responded to a question regarding the functionality related to multiple file uploads (submitted by yours truly). Generally, the manufacturers have a good deal of flexibility. They can upload a file and then edit the specifics online in DDR. They can also upload multiple files with either the same or different NDCs. If they have not yet certified, the new upload would either overwrite or append the existing data. If the manufacturer has already certified, then the new data would trigger the need to re-certify.
CMS also reviewed some additional functionality that they are considering. The specific list of features and timelines is still open, but CMS wanted to at least give the audience a preview of some of the things they were thinking about:
• Override Feature:
The ability to allow a temporary override feature will allow manufacturers to update read only fields. Currently, if a manufacturer has a reason to update specific read only fields (such as S, N or I designation), CMS must work with the manufacturer to make the change from their end. CMS would prefer not to be responsible for updating a manufacturer’s data. Therefore, CMS would like to provide the ability to allow for opening the fields for edit on a temporary basis.
• Data View:
The ability for CMS Central Office users to view and work with manufacturers’ submitted values would allow CMS to work more closely with manufacturers and to view and discuss details of submitted files.
• Limiting the use of Unit Type Each:
The manufacturer should limit the use of the unit type “Each”, and should not have more than one package size where unit type is Each.
Future System Enhancements:
o An indicator to show when data was submitted late.
o Ability to display base rebate agreement information.
o Ability to view deleted NDC (such as where a wrong NDC number was entered in error).
o A “Calculate URA” feature, and the ability to see the variables that went in to the URA.
o Interest Calculation information support.
In the last part of the session, CMS discussed the growing interest in data related to Medicaid Reimbursed products. Without stating specific parties or agencies, a general interest in being able to evaluate whether all the drugs that should be reported are being reported, and whether there are drugs being reported that should not be eligible under the program was expressed. The discussion also described the increased communications between CMS and the FDA when reviewing and qualifying drugs for the program. CMS also reiterated the importance of the regulatory function at the manufacturer work closely with the FDA to make sure that they have an accurate understanding of their products, so that the manufacturer can:
• Know what is considered a covered outpatient drug under the Medicaid agreement
• Know that their reporting to CMS is complete and accurate
Lastly on this topic, manufacturers are encouraged to keep in close communication with CMS on the policy side if they evaluate their list of NDCs and identify any potential issues.
In closing, I reiterate that I wrote this from notes taken during the course of the session Wednesday. I hope that it is fairly representative of the discussion, but I am not attempting to represent this posting as a complete and accurate transcript, or as any specific statements from CMS. Thanks!
Posted by CIS Moderator at 5:20 AM