PDA

View Full Version : Medicare Changes -- Please Read & Get Involved!


Harrison
12-02-2006, 09:03 AM
ADRSupport friends,

If you carefully read some of the news about Medicare in the article library, you will see that CMMS is reviewing parts of the U.S. policy that covers lumbar arthroplasty for Medicare patients. The issues are a bit confusing (it’s more than covering patients 60+ years), so I have a call into one of the CMMS specialists who may be able to help provide guidance.

I wanted to encourage people to submit feedback to them, but even that request is a bit tricky, because:

- It appears that the CMMS site requires you to create an account/password – after you submit feedback!
- The issues are multifaceted and not necessarily clearly defined; e.g., ADR seems to be a small but significant part of the discussion.
- IMHO, the issues and their website are not conducive to constructive communications. In the coming days, I’ll see if I can get clarity on the issues.

You may provide feedback on the CMMS issues directly, by going to http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp
Scroll to the bottom, see "submit feedback." They don't make it easy, eh? http://adrsupport.org/groupee_common/emoticons/icon_rolleyes.gif Or if you prefer, simply reply within this thread; I'll consolidate the responses and send along to CMMS.

See all the recent articles here, (http://adrsupport.org/eve/forums/a/tpc/f/7901036081/m/5731064912?r=1201059912#1201059912) especially the latest one.

Thanks for caring!

LBP
12-02-2006, 09:16 PM
When I went to the CMS website...this is what I found: (re reopening coverage issue for the Prodisc)

http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=197


The Centers for Medicare and Medicaid Services (CMS) is reviewing its national coverage decision (NCD) regarding Lumbar Artificial Disc Replacement.

On May 16, 2006, CMS issued a NCD (NCD Manual Section 150.10) for LADR. The coverage decision was focused on the Charite lumbar artificial disc because that was the only lumbar artificial disc with FDA approval at that time. On August 14, 2006, the FDA approved another lumbar artificial disc called ProDisc.

LADR involves the surgical implantation of the artificial disc device between two vertebrae to replace a diseased or damaged intervertebral disc in the lumbar region of the spine. The surgical implantation of the device may reduce pain, restore intervertebral disc height, and preserve motion.

CMS is opening this NCD for reconsideration with a thorough review of the evidence on the ProDisc lumbar artificial disc and any other lumbar artificial disc that receives FDA approval during this national coverage analysis process.

Public Comment Period 11/28/2006 - 12/28/2006

Harrison
12-03-2006, 09:13 AM
LBP, thx for sharing...unfortunately, there's more to the issue. It's a big onion, so to speak! More on this soon...as soon as I get a call back from the CMMS. http://adrsupport.org/groupee_common/emoticons/icon_confused.gif

sahuaro
12-03-2006, 10:40 AM
Thank you both for posting this. I have some feelers out as well to my "sources" to figure out if this is a medical or political issue....

Harrison
12-12-2006, 06:14 PM
Folks,

I had a conversation with a CMS official, but I must confess I’ve not taken the requisite billion hours to really delve into; research; analyze and present the distilled issues at stake with this multifaceted issue.

For what it’s worth, here’s a few excerpted comments from my conversation with a helpful CMS employee that may guide your possible actions:

2. Under the reconsideration of the LADR national coverage determination it clearly states that the reconsideration will involve a thorough review of the evidence on the ProDisc lumbar artificial disc and any other lumbar artificial disc that receives FDA approval during the national coverage analysis. Comments should be within the scope of this reconsideration.
3. Comments can be made on our web site by clicking on the highlighted word comment at the top of the tracking sheet.
4. As stated in the tracking sheet CMS is particularly interested in comments regarding clinical studies and other scientific information about the technology under review (ProDisc or any other disc that receives FDA approval during our review process) and the short and long term outcomes documented in these studies.

If you care to comment, with the above in mind, visit the aforementioned link and click on the comment button found at: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=197

ADR in the USA
12-12-2006, 07:45 PM
What Medicare does determines what everyone's insurance will do.

Thanks for this link. My comments have been submitted. Now let's see what comes from the information they gather.

Using Santa as my advocate, my wish list submission includes Medicare authorization of multi-level Maverick shortly after FDA approval in the Summer 2007.

LBP
12-12-2006, 11:35 PM
To everyone with a prodisc in your body, please submit a comment sharing your story of how it has changed and improved your life. Even if it's "only" anecdotal rather than some pubished study by a physician...it's still powerful and valuable information that is hard to ignore!!!!!

Trish
12-20-2006, 01:59 AM
Anyone want to hear my unsolicited, cynical, self-aggrandizing and over-simplified yet amusing opinion?

I think they just found a way to save $400 mil from their budget, (See art. ref. above in Harrison’s comment). No wait a mintue …now I’m being just plain silly…..what government agency anywhere in the world would do a suicidal thing like that?

There are three major treatments for severe and prolonged lumbar back pain:

1. Fusion
2. Physical Therapy*
3. Lumbar Artificial Disc Replacement(LADR)

*(a/k/a special cross-discipline PT) They claim it’s not just PT, but a cross-disipline, multi-specialty whole-patient approach where your entire health care team actively communicates through follow-ups and conference with the patient and the whole team, if poss. (Whew. Sounds impressive doesn’t it?).

Putting it very simply recent studies have shown:
ADR vs. Fusion = ADR wins
PT vs. Fusion = PT wins
Doing nothing vs. Fusion = Doing nothing wins, ref.the Spine Patient Outcomes Research Trial (SPORT) (http://jama.ama-assn.org/cgi/content/full/296/20/2441). (not sure about this one I read the study results and it is not easy to say

Having experienced this 3-week treatment for a multicenter study in Bergen, Norway. In my humble opinion, it was just PT with good follow-up. Please pardon my sarcacism but, I thought that used to be called simply called doing one’s job well.

In Mirza’s presentation below you will see reference to a small study in Norway. Well the subsequent study I was involved in had 300 patients (50%/50% PT vs. ADR) with a 2 yr follow-up prior to publication. They are expected to publish in the summer of next year, 2007


“What the heck is she talking about?!!” ……………….you quietly ask yourself?


I think they are hearing about the studies in UK, Norway and Sweden where the ADRs are being compared to this special type of PT, ref. the reference Mirza presentation. If you can stay awake in the middle where Mirza wanders off into the quasi-science of statistics, tests and studies, the beginning and end of this presentation have some very interesting info on ADR and comparing them to PT instead of fusion, like they are doing in the US studies. and PT (I link the NASS Spring Break Itinerary (http://www.spine.org/springbreak06_presentations.cfm) because it has oodles of informaiton. You’ll find the link to the referenced presentation at the very bottom of the page.)This was the 3rd presentation given by Mirza during NASS’s 2006 Spring Break meeting, ref. Surgery for Chronic Back Pain: Artificial Disc Replacement - Methodological Concerns ,
Sohail K. Mirza, MD MPH

I especially like his simple and direct conclusion: "Lumbar fusion for chronic low back pain offers little or no benefit compared to
non-operative treatment. Artificial disc replacement is not inferior to lumbar fusion."

If you live life by the premise that money is everything and you would do anything for everything, or something like that. I don’t (allegedly) but it’s a pretty good predictor of human behavoir, don’t ya think?

If fusion is a defunct surgery, as the ADR studies are showing, then (CMMS) is probably wondering “Why are we covering for 2 types of expensive surgeries when one of them isn’t even as good as doing nothing….(or is that “as good as PT”, I get confused)??!!

They might not be able to get rid of fusion altogether, but decreasing it to an earlier level…say the $80 million of 1993 …..and presto……CMMS has $400 million.


Happy reading.

Trish
P.S. Harrison, you might want to delete this from the string before you forward it to CMMS....lol

Harrison
12-20-2006, 08:01 AM
(CMMS) is probably wondering “Why are we covering for 2 types of expensive surgeries

With the health care budgets in such disarray, I'm sure this is one of the challenges CMMS is facing! Unfortunately, the budget constraints must be driving the agendas.

Trish, thx for your assessment and comments. If you have some extra time in the coming days....you're hired! http://adrsupport.org/groupee_common/emoticons/icon_razz.gif