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Birdbomb
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« on: February 05, 2007, 10:31:52 AM »

I just got a call from my favorite reporter asking me my reaction to this news.  I am searching for links and will post them ASAP

My initial response is shock.  I thought for sure with they would approve with all those public letters of interest.

WOW!  This blows me away!
« Last Edit: February 06, 2007, 11:34:17 AM by Birdbomb » Logged

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« Reply #1 on: February 05, 2007, 10:35:17 AM »

http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=195

Decision Summary


CMS is proposing that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we propose to issue a national noncoverage determination for this indication.

We are requesting public comments on this proposed determination pursuant to Section 731 of the Medicare Modernization Act. We are particularly interested in comments that include new evidence we have not reviewed here. After considering the public comments and any additional evidence we will make a final determination and issue a final decision memorandum.[/b][/size]
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« Reply #2 on: February 05, 2007, 10:41:12 AM »

CMS proposes noncoverage on nerve stimulation for depression

UPDATE 1-US Medicare rejects Cyberonics depression device

WASHINGTON, Feb 5 (Reuters) - Medicare will not cover Cyberonics Inc.'s (CYBX.O: Quote, Profile , Research) implantable device to treat patients with depression, the U.S. insurance program for the elderly and disabled said in a proposal released on Monday.

Medicare "does not believe there is a treatment effect directly attributable to VNS therapy based on the current evidence," the agency said.

After the decision, shares of the company were volatile and down 10 percent in after-hours trading. The shares closed at $22.55 on the Nasdaq.

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The company had asked Medicare for a national coverage decision on its VNS Therapy device, which has faced resistance from private health insurers who mostly pay for it on a case-by-case basis.

Insurers often follow Medicare's lead when setting their own reimbursement policies.

Representatives for the company could not be immediately reached for comment.

In its decision, the Centers for Medicare and Medicaid Services said that while depression is a disorder that is hard to understand, there is sufficient evidence to show that VNS Therapy was "not reasonable or necessary ."

The agency said clinical trials of the device, approved by the Food and Drug Administration in 2005 for patients with treatment-resistant depression, failed.

"Further observational study and statistical manipulations of data from this group of patients provides little weight in the determination of reasonable and necessary," it added.

Medicare is expected to make its final decision in May after receiving public comments.
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Bernard
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« Reply #3 on: February 06, 2007, 02:08:09 AM »

Quote
Cyberonics' nerve-stimulation device to treat chronic, severe depression shouldn't be covered by the Medicare program for the elderly and disabled, U.S. health officials said Monday. The company's shares plummeted in after-hours trading.

The device is "not reasonable and necessary" for that treatment, the Centers for Medicare and Medicaid Services said in a posting on its Web site. The device costs $10,000, with the bill rising to $25,000 when the cost of surgery is included. The rejection would have no impact on use of the device for epilepsy, a treatment for which the Houston-based company won approval in 1997.

...

If the agency's proposed nationwide rejection of the Vagus Nerve Stimulator Therapy System is adopted after a 30-day public comment period, that would end case-by-case approvals that have occurred around the nation through regional Medicare claims processors, said Steve Brozak, an analyst with WBB Securities.

"We are extremely disappointed," George Parker, Cyberonics' interim chief operating officer, said. "We will not rest until all eligible patients have full parity in access to VNS Therapy."

The company encouraged doctors, patients and families to express their support in comments to Medicare.

Cyberonics doesn't get answer it wants
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labrat
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« Reply #4 on: February 06, 2007, 08:37:02 AM »

I think it is discrimanated against just like insurance is. Insurance only pays 50% on mental issues. Just as the air that I breathe, my VNS keeps me alive. This make me upset and angry.

Labrat   :im_033:  
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Bernard
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« Reply #5 on: February 07, 2007, 01:02:51 AM »

It appears that Medicare will be taking public feedback on the issue for the next 30 days.  You might offer them your  :Two Cents:  
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Rocking4Epilepsy
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« Reply #6 on: February 07, 2007, 01:46:25 AM »

Maybe this is a good sign....
WIth all the people who are having major trouble after getting VNS..

Do you think Medicare refusing may be a blessing in deguise?


Bernard, Can you PM me the link or where to toss my  :Two Cents:  
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Bernard
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« Reply #7 on: February 07, 2007, 07:04:26 AM »

Jen, I don't have the contact info - I know what you know from reading the news stories referenced above.  I would suppose Cyberonics would be happy to direct interested parties to the right place.
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Rocking4Epilepsy
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« Reply #8 on: February 07, 2007, 07:31:18 AM »

Thanks Bernard...
I found It :)  
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Arthur
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« Reply #9 on: February 07, 2007, 07:33:55 AM »

If Medicare denies coverage of VNS for depression, what will happen to Medicare patients with existing VNS implants for depression when their VNS generators require replacement due to a depleted battery? For that matter, would Medicare cover routine treatment for existing VNS depression patients such as monitoring and dose adjustments? One would hope that Medicare will handle these questions in a humane manner.
 
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Rocking4Epilepsy
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« Reply #10 on: February 07, 2007, 07:56:45 AM »

That is an EXCELLECT question...
If I were you I would be on the phone with CYBX and ask them what is going to happen.

I know others have had battery problems recently and had to have them replaced.

I would hope CYBX would be an updstanding company and make sure their patients are taken care of.

hugs
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labrat
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« Reply #11 on: February 07, 2007, 06:38:17 PM »

I've already asked the question and have not received an answer.

Labrat
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Birdbomb
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« Reply #12 on: February 09, 2007, 05:57:37 AM »

Medicare cutting VNS is just the tip of this iceberg.

I got a call last night from my favorite mental health expert and we talked at great length as to the ramifications of this.  She only sees military active duty, their families and retired military and families.  She chooses not to accept civilians.  Her contacts with Triwest are impressive.

Triwest is taking a 10% pay cut on these health care providers. In a time of war.  This means less providers will accept Triwest, fewer providers will be willing to work for the government. Less medical care will be available. And a lower caliber of available doctors will be taking care of these families.  Less medical services will be approved no matter the need.

Saying she was upset is like saying the suface of the sun is a little warm.

VNS will still be available, BUT it may have to come out of pocket.  Who can afford $50-80,000 surgery that may or may not work?

The denial is just a small ramification of the problem, the REAL issue is the hugh budget cut to Medicare.  Congress tried this about 20 years ago and it was a fiasico. (I am speaking form the military aspect)  It took years to recover.

We are in for some very rocky times.   :So Sad:
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labrat
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« Reply #13 on: February 09, 2007, 05:28:59 PM »

I'm on this board to offer hope; the VNS has done wonders for me and my situation with TRD. It has improved my life 100%. ALL this with Medicare is very disturbing to me.

Labrat   :So Sad:  
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labrat
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« Reply #14 on: February 09, 2007, 05:32:33 PM »

I've already added my  :Two Cents: +


Labrat       :So Sad:  
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« Reply #15 on: February 17, 2007, 02:27:32 PM »

'''In its decision, the Centers for Medicare and Medicaid Services said that while depression is a disorder that is hard to understand, there is sufficient evidence to show that VNS Therapy was "not reasonable or necessary ."'

What is this evidence? Has medicare proven what this evidence is?
 
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Rocking4Epilepsy
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« Reply #16 on: February 17, 2007, 02:44:21 PM »

Quote
'''In its decision, the Centers for Medicare and Medicaid Services said that while depression is a disorder that is hard to understand, there is sufficient evidence to show that VNS Therapy was "not reasonable or necessary ."'

What is this evidence? Has medicare proven what this evidence is?
Can I just ask?

Have you taken some time to read some of the threads here?
Have you read some of the horror stories the VNS has done to chiildren?

I feel medicare is taking steps in saving much harm to others by denying this device.

Can I ask  what meds your dad has taken?
How long he has had depression?
What state he had the implant surgery done in?
Why would ANY doctor do this surgery without a gaurentee payor?

Did your dad sign any paperwork stating HE would pay for this?



 
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Bernard
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« Reply #17 on: February 18, 2007, 12:30:35 AM »

sisymay, Medicare is claiming that the studies that were done for VNS and depression did not show a clear therapeutic effect.  A national non-profit public interest group, Public Citizen, has been lobbying the FDA on the subject:
Quote
While the long-term phase of Study D02 certainly was one study submitted to the FDA, it was not the most important one.  In fact, it was a nonrandomized extension of a short-term (12-week) study called Study D02.  In the short-term phase of Study D02, patients with treatment-resistant depression were implanted with the VNS device and then randomized to have the device turned on or not.  The strengths of this study design are obvious, notably assuring that the two study groups were similar at enrollment and thereby controlling for any confounders.  But the advertisement makes no mention of these most-important results: at the end of 12 weeks there was no statistically significant difference between the two treatment groups on the primary outcome variable (p=0.238) in the short-term phase of Study D02.  In plain English: the primary efficacy study failed to demonstrate efficacy.  For the long-term phase of Study D02, patients whose VNS device was not turned on in the short-term phase were allowed to have their devices activated.  However, the doctors and the patients were not blinded and concomitant therapies were permitted.

Letter to FDA requesting the immediate halt of Cyberonics ads for vagus nerve stimulation devices (HRG Publication #1770)

and more...

Quote
On August 12, 2004, scientists at the FDA overruled a 5-2 Advisory Committee vote and declared VNS
« Last Edit: February 18, 2007, 12:31:07 AM by Bernard » Logged

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Arthur
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« Reply #18 on: March 05, 2007, 04:26:09 PM »

Well, I just found out the answer to my earlier question as to whether Medicare will continue to cover VNS for TRD for patients who were implanted before Medicare's recent annoucement of non-coverage. I had my VNS implanted in the middle of April, 2006. I had numerous problems, which ultimately led to a re-implant of new leads the last part of February, 2007, just before the recent Medicare announcement of non-coverage.
     The hospital filed it's claim with Medicare, along with plenty of supporting documentation from my psychiatrist and my neurosurgeon. My claim was denied, based upon Medicare's policy of non-coverage for VNS for TRD. I have no reason to believe that this denial will be reversed on appeal, and expect to be receiving a bill from the hospital for $26,000. in the near future. I will have to sell my house to pay the hospital.
     [/U]Based on my experience and the current atmosphere of uncertainty, I would think long and hard before having any VNS surgery for TRD if one cannot obtain binding pre-approval from one's insurance carrier. Unfortunately, Medicare does not provide pre-approvals.
     As for myself, I have had all the nonsense I am going to take regarding VNS. When I learned about my claim denial today from my psychiatrist, I had him turn off the unit. I don't want to be in a position where it helps me, then have the batteries wear out and not be able to have them replaced.
     In my opinion, Cyberonics has lost any semblence of credibility. Now I hear they are saying that they will provide VNS devices when needed to pre-Medicare annoucement patients at no cost if not covered by insurance. However, Cyberonics will not cover the cost of surgery. That just isn't enough. If they had provided more clinical data on a more timely basis, perhaps Medicare wouldn't have taken it's recent action. I have a feeling that Cyberonics is going to end up folding up it's tent in the not-to-distant future. Who knows? Sometimes things happen for a reason, and maybe that would be the best thing for TRD patients.
     
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Birdbomb
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« Reply #19 on: March 05, 2007, 06:43:21 PM »

Quote
I will have to sell my house to pay the hospital.
Man that is just down right ugly! Arhur I am so sorry that things have turned out this way for you.  Surely there must be some other means! This has opened a window to a nighmare. Labrat had to have her unit replaced after 15 months due to premature EOS, right around the time all this mess was coming to fruition.  She may not be aware of this yet as she was a victim of the recent tornado in Ga.  Her home sustained considerable damage and has not been able to have computer access as of yet.  She too had doccumention that her's was a medical necessity.  OMG.

Quote
In my opinion, Cyberonics has lost any semblence of credibility. .... If they had provided more clinical data on a more timely basis, perhaps Medicare wouldn't have taken it's recent action.

In my opinion, they just didn't have the hard evidence they really needed.  Even though there is some level of improvement for a small margin of TRD patients, they just didn't have the numbers.  That is why they kept submitting the same studies only in a new and improved package.

"Lipstick on a pig."  It might make the pig cute but it's still a pig.

Quote
I have a feeling that Cyberonics is going to end up folding up it's tent in the not-to-distant future. Who knows? Sometimes things happen for a reason, and maybe that would be the best thing for TRD patients.

Many others share those very same thoughts. [/color]
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Electrodes are in me for LIFE!
Arthur
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« Reply #20 on: March 06, 2007, 12:59:15 AM »

Hi Birdbomb,

     It certainly is a nightmare. My doctor assured me that this procedure would be covered. I did everything possible to confirm coverage, including reassurances from the neurosurgeon on the day of surgery. Ay this point, I believe that it would be absolutely foolhardy for anyone to have a VNS implant done for any reason. In my opinion, the former CEO of Cyberonics and his cronies destroyed any credibilty that Cyberonics might ever have had, and that Cyberonics will not be able to recover.
     My current problem seems surreal. I keep asking myself how anything like this could possibly happen. However, in today's health care environment, it truly seems like anything could happen, regardless of how irrational it might appear.
 
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Bernard
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« Reply #21 on: March 06, 2007, 01:31:42 AM »

Hi Arthur,

I'm sorry to hear that Medicare refuses to cover your VNS bills, but you do not need to sell your house.  I'm guessing you are already aware of this and just used a bit of hyperbole, but no bill collector can force anyone to give up their home.  You can file bankruptcy if it ever came down to that.

When my wife went status 3 times within a 6 month span, her ER bills (including ambulance, labs, doctors, hospital,  etc., etc., etc.) totalled something like 32K.  We applied for charity for the hospital bills and they knocked off 60% of their bills.  We then worked out a payment plan for $100/mo (zero interest).  We worked out payment plans with all the other parties too.

Again, sorry about the decision.  Did you speak to CYBX about covering the cost for your procedure and incorporating you into the TRD study that they are having trouble finding enough patients for?
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Arthur
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« Reply #22 on: March 06, 2007, 03:55:38 AM »

Hi Bernard,

     Thanks for your reply. I know that a bill collector can't force me to sell my home. However, the hospital can and will file suit against me, obtain a judgement, and I will be forced to sell my house to satisfy the judgement. Bankruptcy is not a viable option for me. I called Cyberonics, and they are not responsive. I'm in a very bad position.
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Bernard
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« Reply #23 on: March 06, 2007, 06:51:30 AM »

Quote
However, the hospital can and will file suit against me, obtain a judgement, and I will be forced to sell my house to satisfy the judgement.

No, that's what I was saying above.  No court can force you to sell your house to satisfy a judgement.  Call the hospital - I'll bet they will work with you on a payment plan that you can manage.
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Arthur
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« Reply #24 on: March 06, 2007, 03:30:17 PM »

Quote
Quote
However, the hospital can and will file suit against me, obtain a judgement, and I will be forced to sell my house to satisfy the judgement.

No, that's what I was saying above.  No court can force you to sell your house to satisfy a judgement.  Call the hospital - I'll bet they will work with you on a payment plan that you can manage.
    A judgement will become a lien against my home. However, the hospital can then choose other avenues to satisfy the judgement, ruining my credit and pursuing any other assets they can find, which aren't much. The other assets wouldn't cover the amount owed, and I would eventually have to sell my house to make up the difference, unless I want to live with all the hassles of having a very low credit rating, which I do not. Therefore, it is best to sell the house, get more equity out by avoiding a potential economic forced sale scenario, and pay what I have to. My other assets would still be available and I would maintain my credit rating and what little is left of my sanity. Legal judgements are not very therapeutic, and are best avoided if at all possible. Interestingly, the first thing the hospital asked when I told them of the problem was what my house was worth. Before I became disabled, I was a lawyer. I consulted my own lawyer today, and she concured that when the hospital comes after me, this would be the better course of action for me. But hey, these days, everyone is a legal expert, especially if they watch TV.
 
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Birdbomb
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« Reply #25 on: March 06, 2007, 05:23:04 PM »

That is why my house is homesteaded.  There are only two organizations that could possibly take it, the morgage company and the IRS.

Considering the circumstances, trying to get the hospital to reduce the bill may be an avenue.



 

[scarcasm]Wonder if I should add homelessness and hugh hospital bills to the list of possible side effects in the TRD catagory?[/scacasm] : nono :
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Electrodes are in me for LIFE!
Arthur
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« Reply #26 on: March 08, 2007, 07:54:33 AM »

I just received the monthly e-mail newsletter from Cyberonics.
 Although it contains some information on how to obtain insurance approvals for VNS, it makes no mention of Medicare's proposed decision of not covering VNS for depression. In the interests of full disclosure, I believe that it should have done so. I guess the name of the game is "Caveat Patient" , at least as it applies to Medicare beneficiaries.
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« Reply #27 on: March 08, 2007, 11:01:51 AM »

This does not surprise me.  They also encourage implanting in children even though FDA approval only allows 12 yo and up for Epilepsy and 18 yo and up for depression.  

Arthur, the sin of omission has been a bane with this company for years.  My site is riddled with comments from many individuals who have experianced this "lack of disclosure"


Puffery
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"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
Arthur
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« Reply #28 on: March 08, 2007, 02:37:43 PM »

Quote
This does not surprise me.  They also encourage implanting in children even though FDA approval only allows 12 yo and up for Epilepsy and 18 yo and up for depression.  

Arthur, the sin of omission has been a bane with this company for years.  My site is riddled with comments from many individuals who have experianced this "lack of disclosure"


Puffery
     Next thing we know, they'll be dreaming up a VNS intra-uterine implant if one or both parents have epilepsy or depression. :fear:  
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« Reply #29 on: November 23, 2007, 05:55:44 AM »

Medicare:  Just Another Nasty,Government System!
This does not surprise me, after dealing with Social security!  Everyone will have to fight against this system, like fighting against insurance companies.  I will say what I said when fighting against Aetna; you are refusing to look at the benefits of VNS on patients that have TRD.  They will not look at the data!  They will just keep saying; it is experimental and not needed.  People with mental health issues will have to keep beating this system down, until they pay for this needed treatment.  People are dying from depression, that is a fact.  They are acting just like the insurance companies!  The  amount of life & job loss is staggering from depression.  VNS could help much to save this and restore life to people so that they could keep working and have their lives back.  The bottom line is this:  it's either suicide or VNS to save someones life.  If someone is dying from a disease then treatment is needed to help!  If a person is dying from cancer then chemotherapy would be given.  That is the comparison I gave when fighting Aetna.  So, what is the difference here?!  I basically stated that fact when fighting with Aetna.  If the medicines stop working, and other treatment is denied, then what options are available?!  Death, as I was not willing to suffer with the pain of TRD.  I was not willing to feel that way the rest of my life.  And as far as money goes, I would like to see the budget of medicare, and see where their money goes!  I bet there is money available to pay for VNS.  I bet they are spending money on things that are NOT needed!!  Let's see how much money they have, and what are they doing with it, where is it being spent!!  They need jurisdicition over them!  Damed bastards!   :Really Mad:  This fight can be won, but it is going to take awhile.  Maybe several years.  If I can beat social security alone, then we as a group of people together can beat another cruel government system.  It is only a matter of time.  Anyone can use this letter in this fight against the systems, to provide mental health care for United States Citizens! :FYI: We must keep fighting for our rights!
Sincerely,
Bonnie
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