Thursday, September 16, 2010

MDRP 2010 Conference - Current CMS Rebate Data, Operations and Technical/Systems Updates

Kim Howell, Meagan Khau, Tamara Bruce, and Dona Coffman from CMS

April 27, 2010 CMS published a State Medicaid letter that addressed the rebate percentages, rebate off-sets, and managed Medicaid provisions. It is recommended that we all take a look at it on the CMS site. There is also information on the policy spotlight page and manufactures should log on and take a look and the items posted.

On August 11, 2010 there was guidance on the identification of pediatrics and clotting drugs. This information was included in state and manufacturer releases, as well as being posted on the CMS site and in the DDR system.

CMS will be doing three provisions in the AMP Final Rule. The proposed rule is currently out and comments are due October 4, 2010.

The operations team had several updates to provide:
They are currently hiring for several positions. They have been at five staff for many years now and will be adding around eight more in the next few weeks. They have just hired someone with experience on the industry side who will bring that perspective to the team; this is exciting for them. And would love to have more like her. One of the positions is for a Dispute Resolution staffer. The positions are located in Baltimore, and unfortunately, there is no moving reimbursement offered to the candidates.

CMS has been sending out a lot of invoices with zero URAs and will be doing so for the Q310 as well. There is just not enough time to get those URAs changed but are working on it and hope to have it completed by the Q410, but that timeframe is not solid. Manufacturers must be sure to do the URA calculations for their rebates if it is not yet on the invoice for all NDCs. It is everyone’s responsibility not just CMS.

Clawback provision might have impact on the operations team and will take time away from other processes. They will have to engineer the off-set calculations and will also be under scrutiny for that work which also takes time. In addition, they do not make the decisions and have no idea when any guidance will be coming down the pike.

CMS is required and is working with OIG on late payments. OIG has begun to submit letters to manufacturers saying they are late with their payments and which can trigger penalty fines. CMS must provide a report on active drug information that is not submitted or when there is an incomplete submission. Be sure to go into the DDR system and ensure you are in compliance. If you are out of compliance address it immediately, before you get a letter. It is thought that the first letters were just warnings, however that determination is up to the OIG and not CMS. CMS currently tracks how many late submissions there are and tells OIG monthly AND quarterly. If you are a repeat offender you can be sure that your company will be flagged for these late submission penalties.

Last month the operations team was able to make the changes to the DDR system for date fields – please log on and take a look. If you encounter issues with the new fields please email the DDR support address and let them know immediately. At this time there is no official time frame on when this data needs to be entered into the system by the manufacturers before a late penalty is assessed, however it is suggested that you do it as soon as you can

Coming soon: the URL will change for the DDR system. Currently you cannot search for “DDR” on the web, so be sure to look for the informational letter coming to those who people who are listed as users of the DDR system.

CMS has completed the transfer of five states to the electronic file system. They will be working to get others transferred.

FYI on the system: If your utilization is 50% higher or lower than previous data you will get a warning email to ensure it was not an error.

For the state agencies: If your state’s quarterly utilization data is missing from the CMS site you will get an error message each quarter until it is fixed. States must have all data back to 1991 and supply CMS with that data for their archive information.

One attendee questioned that a state has asked for pricing data because manufacturers are having to calculate the URA while CMS is still setting it up (and currently providing only zero URAs). Can they? No, the states should wait for the ROSI information from the manufacturer.

At this time there is no directive on how the states will submit their managed Medicaid invoices. And states are not mandated to move to electronic from paper. It is a goal, but CMS cannot force states to go paperless. CMS did say that Managed Medicaid claims should be processed just as the FFS claims have been processed. However, they cannot speak directly to any conversations they may have had with the states on this subject.

There will be upcoming forms, processes, and language forthcoming… be sure to comment on them if you have a comment or concern. Right now they cannot speak to issues around CoT or the 5i drugs – if you have a question email it to

It may be helpful for manufacturer GP staff to give their IT staff a warning that once CMS gets the URA data calculated and loaded for the states you will have a large influx of PQAS invoices with the new URA detail provided where the zero URAs are currently.

For any guidance on issues like line extensions refer to the PPACA and the national rebate agreement for your reasonable assumptions and look for any guidance that may come through in the future.

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