Monday, October 18, 2010

To Be or Not To Be?

Seems like a few of our readers are struggling with insomnia and have become a bit antagonistic over this entire vertebroplasty/kyphoplasty issue.  Insomnia is not suffering.  Many industry professionals have come to recognized that your identity is imposed upon you by your job, and by your possessions, finally you realize that you are not in control  of your life.  Unfortunately, proponents of VCFx have had to defend the efficacy of these procedures the last year.  It was reported on 10/18 that a growing number of third party payers are reconsidering their coverage of VCFx procedures.    Dr. Christopher Bono reported that at least three insurers have issued draft policies that would end reimbursement payments for VCFx procedures, and in some cases kyphoplasty.

Noridian Administrative Services, LLC manages Medicare payments for 11 Western states.  An LCD, aka a local coverage decision was issued in May of this year, and physicians and companies had through September 6 to submit comments to the coverage decision.  Noridian is now writing its final policy which should be ready sometime around the first quarter in 2011.  This coverage could be terminated, or Noridian may adopt provisions on when it thinks the procedures are appropriate and worth covering.

Dr. Bono believes that Noridian's decision carries a lot of weight with other insurers, so, this could potentially have a cascading effect with other carriers.  Surgeons and companies are concerned that this decision could impact the number of procedures, as the majority of these patients are the elderly.    The recently published AAOS guidelines, and, the study in the NEJM have set off a maelstrom effect in the industry whereas proponents of vertebral augmentation (kyphoplasty) have distanced themselves from vertebroplasty procedures.  But the question must be posed to our readers, does augmentation actually restore the height of the fractures vertebral body?  Or, is this procedure designed to eliminate pain, restore some functionality, and potentially lower the cost of care?  Noridian's argument is that there is an absence in the literature that demonstrates the efficacy of either vertebroplasty or kyphoplasty.

The question must be asked, is there a pattern of overuse and misuse of this procedure?  Are IR's and surgeons injecting cement into too many levels  resulting in a disturbing amount of post-op complications?  Many surgeons and IR have risen to the defense of these procedures, yet, they concede that there must be stricter guidelines.  Interestingly enough the two groups commented that they take the misuse of these procedures seriously, yet, the question must then be asked, how do you police yourselves?

A touchy subject?  Of course it is.  Considering that companies like CareFusion, Stryker and ArthroCare are in the process of releasing new lines, no wonder some of our readers are struggling with insomnia and are a bit antagonistic.   One must consider William Shakepeare's opening line of the soliloquy in Hamlet; "To be or not to be, that is the question, Whether 'tis nobler in the mind to suffer the slings and arrows of outrageous fortune, or to take arms against a sea of trouble, And by opposing, end them.  TSB wants to know what will be the outcome?

22 comments:

  1. Contraindications!!!!!

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  2. As I said the other day, its about the crossover rates. Kallmes had 8 of 64 (12.5%) patients assigned to vertebroplasty cross over to the sham injection, whereas 27 of 61 (44%) in the sham group crossed to vertebroplasty. That's a huge difference. What if the cross over rates were 0 and 100% respectively, thus *everybody* had a vertebroplasty because the sham didn't work? Would AAOS still say there was no difference in the groups? Intent to treat is flawed with the crossovers.

    Here is a link to Bono's NASS position statement.

    http://www.spine.org/Documents/NASSComment_on_Vertebroplasty.pdf

    Some good points but no mention of crossover rates or the fact that ITT dilutes the effect of the intervention- particularly with high cross overs. This is the best NASS could do?

    And for disclosure, I do not work for a vertebroplasty company, sell their products or use their wares. I am someone exasperated by this business and frustrated to see that one of the good procedures is at risk because of misinterpretation of data.

    Is it over prescribed? Possibly, probably. How do we police that? That's for the MDs but can we not throw the baby out with the bath water. And for f**k's sake don't leave the docs with only kyphoplasty ($$).

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  3. Word is Arthrocare is divesting itself of Spine Business Unit--maybe they see the writing on the wall

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  4. This topic bites. No one on this blog is interested in a non-surgical procedure that has such little bearing on our industry. Likewise, very few would argue that kyphoplasty is dead in the water. Let the IR guys have vertebroplasty. Let's move on, shall we?

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  5. Isn't the purpose of nearly every procedure designed to eliminate pain and restore some functionality? If the purpose is to save money/cut costs it would be interesting to see a study showing percentage of vertebr/kypho patients that turn to fusion in the future anyway?

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  6. I have a genuine orthopod doing VP as a 1 day inpatient procedure. He is using Cortoss. He just wants to see how they are doing the next morning. I go with him on his rounds and watch these patients hug him and tell them how good they feel. This procedure WORKS! VP or KP.( Cortoss Just happens to be what he uses) How many of you guys out there have ever rounded with your surgeons? I'm talking seen patients walk in the clinic-pre-op and walk out 6-8 wks post-op I've seen kp/vp and and many instrumented occiput's to asshole. If you have such a good relationship with your doc go to clinic with em and see what effect your products have on em. You might be surprise to see that.

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  7. Cortoss might be the definition of "overpriced" and unnecessary. "he just wants to see how they are doing the next morning" is code for, "doc do it inpatient so hospital doesn't get killed on reimbursement". Have fun with the DOJ, new guy! Cortoss uses a study/marketing piece that refers to like a 67% extravasation rate. LOL

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  8. Not a new guy. Sold metal for 7yrs now with the majors. Just stating that he uses Cortoss since that is the jist of the post. And saying to all you out there if you think you have such a damn good relationship with your doc then ask him/her if you can round with them or clinic with them. Go in the trenches so to speak with them. 7:42 you're an ASSHOLE! Notice I didnt post anonymous!

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  9. 7:42, start educating yourself before spouting your clearly biased opinions. Reported leak rates vary from 0 to almost 90%. It all depends on what techniques and definitions you use to identify them. It has been presented and printed that PMMA and Cortoss leak rates are the same.

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  10. You know what 742 now that I have thought about it I'm convinced your an idiot. let me pose a scenario to you: You have a VCF. let's take procedure out of the equation. In other word, it doesnt matter if its KP or VP. Would you rather the surgeon used PMMA and leave what amounts to $50 worth of cement in you and throw $1500 worth of equipment away after the case? Or use Cortoss which cost a lil more has distinct advantages over PMMA which is a 50 yr old if not older technology and throw away $500 of equipment away after the surgery?

    Think it through. Oh and before you want to measure dick's as far as knowledge goes you better know that person's background.

    Notice I didnt post anonymous again

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  11. Thanks James! Now we know exactly who you are.

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  12. James ever heard of HIPPA? Where do you live?

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  13. James, we are all impressed that you have one "genuine" orthopod that can stand you. Congrats. Cortoss without a balloon is still a VP. I wonder if your doc knows you are being paid more for that case than he is...

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  14. James, you are clearly the village idiot.

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  15. What does HIPPA have to do with it.? Surgeon's not making an introduction of the patient to me. Rather the other way around. I'm going to know the patients name anyway when I go into the case. Oh now I get it. You are the spine rep ( and I use that term loosely) who is standing on the outside of the O.R. looking to get in. Go get your F'in Shinebox!

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  16. James you sound like a complete douche. If your account had any balls your ass would be out! I bet you wear a lab coat around, right?

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  17. James, you are the reason the spine industry is going down (and not the way you like it)...we get it, you couldn't hack it in chiro school or selling copiers---now you really feel like you are making a difference because you did "rounds" one morning with your ortho boyfriend.

    You must give one mean "handy".

    Just drop the cement off before your next case and go try and sell a product that requires you, and your 7 years of knowledge, to be at the case.

    Think hard on what that product is James, odds are you don't sell it. Why? Cause you don't matter. The surgeon does. Not the rep. You are just another "rep in the window"...

    I heard Target has the game "operation" on sale this month...try your luck at that

    Let me know how your patient does the following day too

    Cheers

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  18. Cortoss's IDE states 63.8% extravasstion rate(PMMA or Cortoss). Still a VP and still think it won't take many cases before one of those leaks leads to a major complication.
    James, you're the guy that good surgeons make fun. You're the only one that doesn't know it...

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  19. OK think we've all digested this topic.
    TSB...next subject? Please
    How about "What contributions have I made to the industry?"
    Thank you for your consideration:)

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  20. ... oh I don't know, I kind of enjoyed reading the verbal beat-down "holier than thou - I round with my docs - James" got from a bunch of E-trade babies. Quality entertainment if you ask me... (which I realize nobody did...)

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  21. Don't all of you reps have anything better to do with you time then talk smack on a blog? go sell something.

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  22. Don't you have anything better to do than write smack in the comment section? Duh................

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