Feds seek to exclude Charite from reimbursment

I just read Harrison article in the library about how the CMMS is about to exclude the Charite disc from reimbursement and how it will make it next to impossible to get any insurance co. to pay if its is left off their list of approved devices. This is not good news for anyone except Medtronics. I e-mailed the following to CMMS.

Charite artificial disk replacement exclusion.

I am a Charite recipients from 12/03. All has gone better than I could have wished for. I know you will be committing many people to a continued life of pain and future surgeries if you exclude the Charite disc from Medicare and Medicaid reimbursement and make force them to get fusions. This is not a game you are involved in. Medtronics has a very strong lobbying effort underway presenting mis-information in order to put off acceptance of the Charite disc until their own Maverick disc can become FDA approved. The Charite Disc is FDA approved now. I was part of the study group that believed so much that there has to be something better that fusion out there for back pain sufferers I put my future in the hands of my doctor and this now FDA approved device. Please let the patient and doctors make their own decision about the patient's health care and not some over paid lobbying force that has their corporate deep pockets. I will be happy to go anywhere and talk to anyone about my situation and how my life has turned for the better. I also know over 100 others who like me have been given a new lease on life thanks to the Charite disc. Again Please vote for the common man and not big business in this matter.

Below is the web address for feed back for the CMMS where I sent this. Anyone pre or post op who feels like I do could you please to the same. I am sure the same decision will be made for Prodisc when it get approved and any other device unless we speak up now.

http://questions.cms.hhs.gov/cgi-bin...site_fdbck.php

Harrison, Maybe you could you send out an e-mail to all registered members so those who do not come here that often can help with this.

Pat

[Harrison]

ADRSupport Members,

Sadly, the Centers for Medicare and Medicaid Services made a decision this past week that may affect tens �if not hundreds � of thousands of people with debilitating back pain.

Many members from our community wrote and emailed the CMMS to explain their dissatisfaction with Dr. Deyo�s �mission� to single-handedly rob patients of their chosen path of spinal recovery. As well, the trickle down ramifications of this decision are many and will affect benefits like disability as well. Also, patients who are convinced that arthroplasty is the better choice may have to get fused � and fused again down the road - or pay �out of pocket� for disc replacement.

How and why this happened is worthy of a thorough investigation. Perhaps Frontline would be interested in checking this story out � I am sure that they would find a few surprises under the covers! Clearly, the educated consumer is getting the titanium shaft here. Wouldn�t an intelligent outcome be to simply allow the �system� to cover the cost of artificial disc replacement with the properly qualified patient? And thoroughly trained doctor?!

We have seen the memo from CMS and all its shortcomings, but many of its constructs are flawed. E.g.:

- �CMS did not commission an external technology assessment�

- CMS cites poor clinical outcomes and/or lack of clinical data to justify its decision, but they had the same access to the clinical data that the FDA did for approving the Charite�

- Recent patient outcome data (or even the five-year data coming out in 3 months) was not considered

- CMS suggests that they want to hear from the public, but then explain that the voice of the patient community is not relevant: ��Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination.�

A question for CMS: why are you taking away the rights of a qualified patient to be treated with the best available technology?

In the meantime, I would suggest emailing the myopic folks at the CMS, but I doubt they will consider any feedback (see above!). For now, for those of you that have had surgery, fill out the post-op survey here.

Proposed Decision Memo for Lumbar Artificial Disc Replacement
http://www.cms.hhs.gov/mcd/viewdraft...emo.asp?id=170

[Kim]

Does anyone here know how to do an online petition? I know that there are power in numbers and maybe we could get the CMS to listen to us if we got a petition going and got a lot of people to sign and to state why they feel that the CMS should not exclude Charite or ADR as coverable surgical procedures. I know that they tout that most of their clientele is elderly but look at all the younger disabled people who are on Medicare as well. Did they even take that into consideration?
I know that there was a very explicit petition on the web for people against a bill in congress that concerned animal rights. This was signed by thousands and thousands also got to add comments to their petition that went into the government. It was noticed!
This might help us here! Anyone out there know how to set one up?
Kim

[ans]

To be frank, does the high markup of the Charite' disks in the US have anything to do with these insurance denials?