The hard, cold facts of LVRS and lung transplantation are that 5% to 10% die on the table, that another 5% to 10% die from complications and don't leave the hospital, that 35% to 50% report marked improvement after one year,  about 25% are not improved or are worse, and that average life expectancy after surgery is quoted as being 5 or 6 years.  Remember, when you ask for comments from those who have had surgery, you don't get many responses from the failures. LVRS and TX surgery should be last-ditch steps, after the patient has worked through pulmonary  rehabilitation and has at least three independent opinions.  .............   From:  Bill Horden <SOBnSA@AOL.COM>
LVRS and the NETT PROGRAM

First-of-Its-Kind National Research Study Evaluates Benefits and Risks of LVRS

 The LVRS forum on the CTS website

New England Journal of Medicine Effect of Lung-Volume-Reduction Surgery in Patients with Severe Emphysema

Lung Surgery May Help With Emphysema

CCC.COM HEALTH - Study finds removing part of lungs helps some emphysema patients

.
If you would like to post your LVRS Information here to help others 
in their search for insite.
Please send to: LVRS@olivija.com  Inquireing minds want to know !
.

LONG LIST OF LVRS LINKS AT BOTTOM OF PAGE

NATIONAL EMPHYSEMA TREATMENT TRIAL (NETT)
Waiting to Exhale" by Dr. Joel Cooper
Anyone interested in applying for the NETT study
Is Lung Reduction Right for You?
Lung volume reduction for severe emphysema
 Outcomes After Bilateral Lung Volume Reduction Surgery
Peter H. Gott, M.D. Surgery may help end-stage Emphysema 
65 MDs Declare Consensus Exists' For Medicare to Widen NETT & Drop
Randomization for Certain Patients
Protection of Patients in research is faulted
Bud Ellis - No smoking Site . . . . . BUD'S LVRS STORY

The NETT study will end in Dec. 2002

We received this letter from one of our members with permission to share it with all members and members of Congress:

Within the last two weeks, I have received information that 3 different people that have received a favorable decision from an Administrative Law Judge, for nonpayment of benefits.  That benefit being denied was Lung Volume Reduction Surgery.

This is good news for those who had the surgery as a self pay patient, appealed and won.  What about the people who could not and cannot afford the surgery.

Medicare, with the approval of Congress is setting up a two tiered system.

One, for those who happen to have the funds to have procedures as prescribed by their physicians.  Those people can appeal and win and have their money returned.

What of those who do not have the funds to pay for a procedure that their doctor may prescribe?  Those people have no option and are left with no choices. They are left to die.

Two different people who had applied for the NETT study, sanctioned by HCFA/NHLBI are now dead.  They happened to be unfortunate and was randomized to the medical arm of the study.  One had a court decision to have the surgery, the other died with no chance.  Neither is fair, nor ethical.

The NETT study is a failure.  In over 40 months they did not enroll enough patients to have a valid study.  The reason.  They put to many rules and even if one followed all the rules, they still only had a fifty percent chance of having LVRS.  They were required to spend months away from home incurring a lot of expense.  Many simply do not have the money to do this, with no assurances of anything being done to improve their quality of life.

Members of CPPC, I urge you to write your Senator and Congressman and express your views about this two tiered system that is being developed.

Members of Congress, we urge you to take responsibility for HCFA, it is an agency under your control and this must stop.  If the courts can see the viability of LVRS, surely HCFA can do the same.  If not then you should intervene.

Letter from Linda Farris
Sent by Coalition for Pulmonary Patient Care

CPPC

Date: Fri, 7 Sep 2001 16:58:22 EDT
Subject: NETT RANDOMIZATION
To: Pulmonary Coalition@yahoo.com

Being a NETT patient randomized to medical side of study 12/98, I am amazed at how callous the study is.  I was told I was an excellent candidate for LVRS by Dr. Ginsburg at Columbia Presbyterian, who is the surgeon for NETT, yet I cannot have the surgery because they do not do cross overs. In other words, no matter how bad you get, NETT will not allow the surgeon to help you via LVRS.  As far as I'm concerned, this is an immoral stand by NETT.  They are willing to let people suffer and die all because, In my opinion, they don't want to pay for the surgery.   There are hundreds of people who have had this surgery and they are living almost normal lives. It's unfortunate that only those who can afford to pay for LVRS are the only ones who can have it, although fighting with their insurance companies gets results. I believe anyone who fits the criteria for the surgery should be allowed to have it. This is the only moral and humane thing to do. As I understand it, many doctors left the NETT studyfor the reason mentioned above.  They couldn't stand by
and watch patients become so disabled that they couldn't talk and even die simply because of the NETT protocol.
Ann Cotugno


Mon, 6 Aug 2001 06:20:57 -0700 (PDT)
   From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

Ann Thorac Surg 2001;72:649-657
© 2001 The Society of Thoracic Surgeons

Limitations of randomized clinical trials for evaluating emerging operations: the case of lung volume reduction surgery

Robert L. Berger, MDa, Bartolome R. Celli, MDa, Anne L. Meneghetti, MDa, Peter H. Bagley, MDa, Cameron D.Wright, MDa Edward P. Ingenito, MD, PhDa, Anthony Gray, MDa, Gordon L. Snider, MDa a The Overholt-BlueCross Emphysema Surgery Study Trial (OBEST), and the Clinical Services affiliated with the medical schools of Boston University, Harvard, Tufts, and University of Massachusetts, Boston and Worcester, Massachusetts, USA Address reprint requests to Dr Berger, 824 Boylston St, Suite 101, Chestnut Hill, MA 02167

Abstract Although unanswered questions remain, scores of observational studies and several small randomized clinical trials (RCTs) indicate that lung volume reduction surgery (LVRS) offers safe and effective palliation for a relatively well defined subset of patients with advanced emphysema. Nonetheless, Medicare and other insurers stopped reimbursement for the procedure. Subsequently, two multicenter RCTs on LVRS, the National Emphysema Treatment Trial (NETT) and the Overholt-BlueCross Emphysema Surgery
Trial (OBEST), were launched with the stipulation that the procedure would not be paid for outside these trials.  Thus access to LVRS has been denied to patients who could benefit but do not wish to participate in an RCT. Emerging operations, unlike new drugs or devices, pass through evolutionary changes and frequently fail to produce data that meet the scientific rigor required by randomized studies. In such a setting, the observational approach is more appropriate. Indeed, almost all operations in the present surgical armamentarium have been evaluated and have evolved through observational studies without the use of RCTs.  By the time new operations are standardized and qualify for RCTs, benefits for certain patients may be demonstrated and randomization could involve unacceptable health hazards. Patients from this population should be offered the choice between participating in RCTs and having the operation outside the study.
Imposition of financial restrictions that bars access to a therapy with known benefit is a questionable practice.

This was sent to us by one our members who lives in Kansas City area.

JERRY HEASTER:  Uncle Sam is left out of patients' bill of rights

There has been a glaring, and disturbing, omission in the debate over the so-called patients' bill of rights legislation, says a veteran analyst  of health care policy.

"Honesty is missing," said Conrad F. Meier, senior health policy fellow for the Heartland Institute and managing editor of Health Care News. "What we are not being told is how a very large segment of the population, if not the majority, (is) excluded from any of the protection being considered."

Those excluded include tens of millions of Medicare and Medicaid beneficiaries, those in Veterans Affairs and Children's Health Insurance programs, and federal health care plan participants.

This is not a thoughtless omission, Meier contended in a recent letter outlining his objections to Congress' latest effort to protect Americans from abuses at them hands of their health care insurers. The key sticking point among legislators has been the extent to which insured Americans should be able to sue for relief when they think they've been wronged by insurers.

The issue of such legal remedies, however, has been focused entirely on the private sector despite government's pervasive role as a health care insurer.

Ignoring government's role, Meier contended, is "a deliberate move to protect government's own health plans from (their) own failings.(Congress knows) full well (government would incur) a tidal wave of costs defending lawsuits. In the Medicare plan alone, the number of claims denied and the number of medical procedures denied exceeds those in the private sector."

Somebody, he said, should ask why so many members of Congress are so willing to allow government a free pass, yet so eager to expose the private sector to "one of the most potentially expensive health benefits ever mandated."

He has a point. Why, indeed, isn't government a part of the equation when government's performance in this realm is no better than the private sector's?  When the Senate last week passed its version of the patients' rights bill, Sen. Edward Kennedy said the action "brings us a giant step closer" to the day when Americans won't be powerless against arbitrary decisions to deny care based on economic rather than medical reasons.

It can be argued that the problem isn't as threatening as some politicians would have us believe, but even if they're right, what's the justification for excluding the elderly, the poor and the government's own employees? What's good for some Americans should be good for all Americans, assuming the problem is universal.

Viewed in this context, enthusiasm for the patients' rights bill seems to have more to do with politics than economics. Whatever else it might accomplish for patients, expanding litigation opportunities will be a bonanza for plaintiffs' bar. As an economic fact of life, more lawsuits promise to drive up care and coverage costs or diminish the quality of care, or both. Whether what Congress is crafting represents a blessing or a curse remains to be seen, but whatever it proves to be should be shared equally by all Americans.

Jerry Heaster's column appears Wednesdays, Fridays, Saturdays and Sundays. To reach him, write the
business desk at 1729 Grand Blvd., Kansas City, MO. 64108, call (816) 234-4297 or send e-mail to:  jheaster@kcstar.com.

RE: FRED VANTASSEL JR. / LVRS
May 2001
I hoped to never have to write this letter, but unfortunately we all knew that it was just a matter of time before this tragedy happened. I know I have written numerous letters to all of you so I am sure that you know this situation well.  My father desperately needed LungVolume Reduction Surgery to save his life and even though FOUR well known Thoracic Surgeons felt it would "Improve his health by 70%", "Benefit him tremendously", and "Improve his quality of life" his insurance company, Medicare, repeatedly denied requests by him and myself to look into this matter and let the MEDICAL EXPERTS decide what treatment was best for him. My father's lung collapsed on March 29, 2001 from a very large ruptured bulla and he died.  My father was discharged home from Cedars Sinai Medical Center in Beverly Hills in February 2001 and told that his lung had a 25% chance of collapsing again.  I was told by Dr. Robert McKenna who is the head of the NETT study at Cedars Sinai Medical Center, "Do I think your father needs the surgery? Yes I do. Are there 300 articles out there supporting LVRS? Yes there are.  Will Medicare pay for it? No they won't and until they will my hands are tied!"   Why is Medicare allowed to dictate medicine?  I thought this was up to the qualified physician.  Robert McKenna MD is also the lead investigator for the NETT National Emphysema Treatment Trial at Cedars Sinai Medical Center.  If his opinion doesn't account for anything then WHY IS HE RUNNING THE NETT AT CEDARS? AND IF HE FEELS SO STRONGLY ABOUT THIS SURGERY THEN WHY HASN'T THE STUDY BEEN STOPPED?
When my father was in Cedars Sinai Medical Center a Resident doctor came into my father's room and said "We are so tired we have done 17 LVRS surgeries in the last 4 days".  If this surgery was so "Experimental" as they say then how can they be doing this many lung volume reduction surgeries??  The NETT study is not doing this many (17) surgeries in four days because as we all know the NETT study is having a very hard time recruiting patients...These are self paying patients... THIS SURGERY IS WORKING!!  Most if not ALL physicians will tell you it does work as long as you are SELF PAYING....BUT if you happen to be "economically disadvantaged" as HCFA so eloquently put it when describing my father to the OFFICE OF CIVIL RIGHTS, then this surgery is "experimental and not proven". HOW VERY SAD!!
If anyone can help answer a few questions for me I would greatly appreciate it.
1. Why is Medicare and HCFA allowed to dictate medicine instead of qualified physicians?
2.  If the physicians that are running the NETT study think this surgery works , then why isn't the experiment/study stopped?
3.  Why was I told by a nurse coordinator for the NETT study that the reason the NETT wasn't stopped is because it is set up to stop if they get a .....set number of deaths ...not a set number of successful surgeries?  (Set up to fail!!!)
4.  Why did Medicare pay for four Medicare beneficiaries to get LVRS after ordered to do so by Administrative Law Judges that claimed that this .....surgery was beneficial and very well proven to work?  Of course this was paid for out of the Medicare fund.  The same fund that denied my father .....and is still denying many others that so desperately need it before they also die!
5.  Why can't anyone calling HCFA, or Medicare get any straight answers? And why don't the people answering the phones know anything about .....this crucial issue?
6.  Why did the office of Civil Rights state that they were told to "Close my father's case by their Washington office because even if they were to.....cite Medicare they didn't have to comply anyway"?? Why is Medicare/ HCFA above the law??
7.  Why did an employee at the CIVIL RIGHTS OFFICE in San Francisco apologize to me and state that he was "ashamed that his office,.....which is set up to STOP disparate treatment against people, is allowing it to happen in my father's case"??  This is a Federal CIVIL RIGHTS .....OFFICE that is supported with tax payer dollars...AGAIN Why is this office "allowing itto happen in my father's case"?!!!!
8.  Why did I get a call on the day I flew to California to bury my father from Ruth Johnson in Washington DC who claimed that she was answering.....my last letter yet still didn't have all of the facts?  She continued to say there was "no National Coverage issue" and after some dispute with me .....she called me back within the hour and said she "did some checking with her policy people and I was right."  The issue to me isn't whether there.....is one or not ..The fact is that the "specialists in Washington DC" are calling to respond to the public and do not know all of the facts!!!! No .....wonder there are so many inconsistencies and no straight answers.
Please help me answer these questions before someone else's time runs out.
My father was a hard working farmer who paid taxes every year and also paid into the Medicare fund. He deserved to get a surgery that his physician said would literally save his life. Instead he was left todie by his insurance company that said "thanks for the payments all these years but now we can't help you".
There are many others out there just like him that also need this surgery and they may not have days, weeks or months to wait.  My father died knowing that he didn't matter to Medicare or HCFA...He was just another statistic in the NETT study...Don't let it happen to someone else!!!

Kim Drummond RN
103 Appomattox Court
Murfreesboro, Tennessee 37130
615-867-0733
615-397-6827

***
After writing this letter I learned that another lady lost her fight against this terrible disease and her insurance company...She was also on her way to St. Louis to see Dr. Joel Cooper this month and unfortunately like my father didn't make it... How many more are we going to let this happen to????
What is the value of human life??? If this surgery could save ONE life isn't it worth it??? I BELIEVE IT IS... I would love to tell my 10 year old son Jaycey, my 3 year old daughter Morgan and my 1 year old daughter Kristian that their PAPA was still alive and didn't "go toHeaven to be with GOD".  I would love to hear him laugh one more time and tell me that he loves me and will see me soon.....He was just 57 years old and had
a lot of living left to do...There are a lot of people out there who's time is running out...WE have GOT to help them....Please help them....Don't let another family go through this...When there is a treatment that will help ....Don't let these people die because of MONEY!!!.

LK Drummond
RE: My beloved and dearly missed father Fred VanTassel.
I will agree that Medicare is totally incompetent.  I received so many misleading and contradictory responses in trying to fight for the surgery for my father Fred VanTassel that I really lost faith in the whole system.  On the day I was flying to California to bury my father..I got a call from Ruth Johnson (HCFA Washington DC) telling me that there was NO National coverage issue when it came to LVRS...She also asked me why my father never "went over into the surgical group if he was as sick as I say he was?"  I  told her "What to you mean transfer over into the surgical group in the NETT ??..YOU CANNOT SWITCH TO THE OTHER GROUP!  She said I was told that a person could switch to the "other group" if his physician thought he needed to" HOW MISINFORMED ARE THEY!!! NOW I REMIND ALL OF YOU THAT THIS WAS HCFA WASHINGTON DC!!! She said she was sending me and my father a letter to state this and wanted to know "where he lived"....I told her that I was on my way to California to bury my father and yes he was "as sick as I said he was".   Then I told her "Fine you send me a letter to state that fact about NOT  being a National Coverage issue  and I will put it with the letter from HCFA, SanFrancisco that says there IS a National Coverage ISSUE and I will put the two together and send them out to every Senator and Congressman so that they know this is EXACTLY WHAT I AM TALKING ABOUT !!!!  INCOMPETENCE!!!!!...WEll she called me back after one hour and said "Mrs. Drummond I did some checking with our policy people and you are right there IS a National Coverage ISSUE on LVRS" and we are "looking into this" How sad that another person had to die to get them to look into it.  I am still waiting on the letter from her that she said she is sending out..haha She changed her story real quick when I said I was sending it to Congress... I am STILL so frustrated with the whole system..even with the loss of my father I am gearing up for another round of letters and information to Senators and Congressman...I have just waited to let my anger subside a little...I will do this out of knowledge and compassion for others and NOT out of ANGER... I will get more accomplished that way.
If anyone knows who I would contact to go to WASHINGTON DC and talk to Congress I am very interested to go....I need to speak out about the run-around and incompetence I have encountered and theloss of my fathers life.  I also want to talk about the CIVIL RIGHTS OFFICE that stated they were "ashamed that their office which is set up to STOP disparate treatment against people is ALLOWING it to happen in the case of my father" THIS is a Federal office that we support with tax dollars!
Thank you again for being my sounding board and GOD BLESS all of you that are going through this and or need the surgery.. I know all to well what a nightmare this can be,
Kim Drummond RN


Subject: Sammie and LVRS
submitted by Linda Farris - Update on Sammie Richey:
Many of you remember Sammie and the fact that he had LVRS on March 25, 1997 in his hometown of, Waco Texas. He appealed HCFA's non-payment of benefits.  He got a favorable decision forMedicare Part B in January 1999.  His appeal for Medicare Part A has been a series of misinformation and delays that are still continuing.  It is now April 2001 and still nothing has been resolved.  Now one has to wonder why all this time has passed without a decision being made.  Sammie wanted me to fill you in on the "wait."  Sammie will edit this before it is posted, so be assured it is the message Sammie wanted to share.  HCFA in the most negligent manner one could imagine has been hard at work-giving everything from, confusing to misleading to down right untruthful information.  This was either done to mislead the patient or they were and are totally incompetent. HCFA after much delaying and/or stone-walling, left Sammie and his attorney to file suit in Federal Court.  A few weeks ago the judge in Federal Court issued an opinion.  He dismissed plantiff's complaint without prejudice as his administrative remedies have not been exhausted. I am going to focus on Judge Smith's decision and the things he had to say about HCFA.  Most of his comments are anything but complimentary.  HCFA's handling of this case left a lot to be desired, not only in Sammie's opinion, his attorney's opinion but also the judge's opinion. Paraphrasing the judge's comments:  Plaintiff (Sammie) submitted bills to Medicare.  It appears to have denied his claim for reimbursement for inpatient care. Medicare records submitted by Defendant (HCFA-Medicare) however, are basically incomprehensible. There is nothing to suggest Plaintiff failed to pursue an administrative appeal.  Defendants either lost plaintiff's records for Medicare Part A without the claim being resolved or they were misleading Plaintiff as to the regard of the status of his appeal. In June and July of 1997 several different letters and forms between Plaintiff and Defendants were exchanged.  On July 25, Sammie's attorney requested a detailed explanation for denial of benefits and requesting an appeal be processed on his behalf.  NO RESPONSE:  Another letter from Sammie's attorney dated December 1, 1997 was submitted with the same request.  NO RESPONSE: Another letter from Sammie's attorney dated Jan. 2, 1998.  Finally a reply in May 1998.  They had forwarded the claim to the Texas Medical Foundation.  No one knows why this action was taken, since Texas Medical Foundation had absolutely no standing in this case.  One more time that HCFA had acted improperly in the handling of this claim.  On June 8, 1998 Sammie got a letter from HCFA denying his total claim.  In a separate letter with the same date, June 8, 1998 notifying Sammie that $2.65 plus the $760.00 deductible were not covered.  The judge said the two letters were at the least confusing.  I think I would have said "contradictory."  First it was a no then a yes. Sammie at this time contacted Congressman Chet Edwards for assistance.  The response demonstrated that even the responsible agencies were confused regarding the state of Sammies appeal. HCFA made reference to the claim being before an ALJ.  To show how confused and uninformed HCFA was, the reference being made of the case being before an ALJ was totally false.   They were looking at Medicare Part B.  Part A had never been heard by an ALJ.  Part B had absolutely no bearing on the appeal of Part A, which was the claim being discussed.  As mentioned earlier, Medicare, after appealing the nonpayment, they did reimburse Sammie for Medicare Part B.
1999 was drawing to a close; however, Sammie's attorney continued to keep in contact with HCFA and Medicare.  They had no idea of the status of Sammie's appeal.  Note this all had occurred over 2 1/2 year's post LVRS.
In Jan 2000, the letters continued to be written on Sammie's behalf.  A letter dated January 14, 2000 indicates the Plaintiff's claim for Part A was denied: NOT because it was an unproven procedure, but because the hospital in Waco was NOT an accepted center.  The notice further informed him his denial of the claim as being unappealable.  A companion letter dated January 14, 2000 misleadingly informed Sammie his Part A claim would be paid due to an Administrative Law Judges decision. NO HEARING HAD TAKEN PLACE.
Now for the thing that takes the cake--defendants (HCFA) asserts Plaintiff (Sammie) had not exhausted his administrative remedies.  Now I ask you is this bizarre? Sammie asserted that pursuing an administrative appeal would be useless.  We can all understand how he would reach this conclusion.
The judge made the following comments: " As previously noted, the administrative record submitted by defendant is incomprehensible.  There is nothing to indicate when, or if, Plaintiff received final notice from any party that his Part A claim had been denied.  The two notices received by him June of 1998 were clearly contradictory, and could be interpreted as granting his claim for benefits as it apparently was in June of 1997.  Up until January 14, 2000, Plaintiff was still receiving letters that could be construed as granting his claim.  Since it does not appear that Plaintiff has ever received a final, definitive notice that his claim for benefits under Part A has been denied, his time for filing an appeal of the Secretary's decision has not passed.  During that administrative process, perhaps HCFA can reconcile the discrepancy that exists due to its agreement to pay Plaintiff's Part B claim but denying his Part A claim, even though both arise out of the same surgical operation."
This decision was issued February 2001.  Sammie's attorney has asked for an immediate resolution to the case due to the length of time and numerous errors on HCFA to immediately pay the claim or schedule an immediate hearing.
Sammie is over 4 years post LVRS, and does not feel physically well, which is why I am writing this letter.  He wanted people to know what was going on.  His case continues to drag on, but he continues to go forward with his appeal.  We should all thank Sammie for his fighting spirit. He has not let time or health problems, stop him.  We all want to say "Thank You", Sammie.
Subject:  Death of Fred Van Tassel
My brother-in-law, Fred Van Tassel. his death could have been prevented by LVRS surgery.....Our government discontinued a program in 1995 that could have saved his life.  Because, he was unable to pay up front for his surgery and then petition Medicare for reimbursement and because he ran out of time due to his condition, "LET US LIFT OUR VOICES FOR OTHER AMERICANS OUT THERE WHO MAY NEED THE SAME SURGERY AND ARE NOT FINANCIALLY ABLE".  Write your Congressmen and Senators....We must speak up so others may live.....THIS IS BLATANT DISCRIMINATION....Medicare knew they had paid for others to have the surgery, only after they had paid out of their own pockets.  What is wrong with a government who gives away Millions, even billions of dollars to other countries and do not take care of or listen to the cries of their own countrymen?  I suppose this is not a so called politicial game we are playing, or is it?  Well, if it is, my brother-in-law paid a much higher price than I was willing to pay, HIS LIFE!  SPEAK OUT - LET YOUR VOICE BE HEARD.....I PRAY HIS LIFE AND STRUGGLE TO OBTAIN HIS SURGERY WILL NOT BE INVAIN AND OTHERS CAN SOMEHOW BENEFIT FROM THE SACRIFICE HIS FAMILY HAS SUFFERED.....AGAIN LETS UNITE IN AGREEMENT AND FIGHT FOR JUST ONE MORE BREATH.
Subject: Part B Medicare

This is to tell you our fight has almost come to an end.  We received our refund check from Washington University, St. Louis, MO for the Part B Medicare.  They did not file with our supplement for the Part A, when they do and they get a settlement, we will get back our deductible and will have gotten all our money refunded.  Jim's surgery was 30 months on the 19th of November, so it has been a long struggle, but well worth it.
Linda Farris


Frank Barrett-NV+a <FBarrettao@AOL.COM>
I am in the NETT program. All participants, whether randomized to LVRS or to the non-surgery control group are followed until the end of the study period (July 2002) or for 4-1/2 years, whichever comes first.
Followup consists of automatic forwarding to the study group the details of all Medicare bills incurred by the patient for whatever reason, telephonequestionnaire every three months, and fairly extensive testing - complete PFTs, CBC blood tests, ABGs, 6-minute walk, oxygen titration, exercise (stress) test, psychological evaluation, review of the patient's daily exercise log book, and, sometimes,  additional tests -  each 6 months for the first year, and once yearly thereafter. One of the reasons given for instituting the NETT was the fact that, prior to that, there was little or no followup on surgery patient beyond 3 months after surgery.
Frank NV
Medicare & pulmanary rehab
From: Bill Horden <SOBnSA@AOL.COM>
Those who are not familiar with the Medicare-paid NETT program (National Emphysema Treatment Trials) to verify the efficacy of LVRS (Lung Volume Reduction Surgery) should understand that a Multidisciplinary Pulmonary Rehabilitation Program (paid for by Medicare) is required before each COPD candidate may be considered for surgery and, whether selected for surgery or placed in the "control" group, must continue regular Pulmonary Rehabilitation (paid for my Medicare) for several years.  If the rumor you heard is correct, each COPD/emphysema patient in the US should be terribly alarmed because it is not just an abandonment of one of our best treatment options, it's a sign that the inmates are running the asylum, again.  We should get to our congressmen and senators and demand that the responsible Medicare personnel be identified and summarily dismissed.Better yet, they should be sentenced to work in a pulmonary rehab facility for a couple of years.
Bill Horden


NETT NEWS
(PDT)
From:  coalition Pulmonary <pulmonarycoalition@yahoo.com>
WE ARE SENDING COPIES OF TWO LETTERS OF INTEREST TO OUR MEMBERSHIP.  ONE POINTS OUT THE LOW ENROLLMENT NUMBERS. THE SECOND, THAT WE MIGHT BE GETTING SOME INTEREST IN CONGRESS. CPPC
++++++++++++++++++++++++++++++++++++++++++++++++
This is information that I received today from UCSD. Glenn
*********************************************************
Latest Information on NETT  We do not have specific information on how patients are doing in the study; however, study results are monitored regularly by an independent Data Safety and Monitoring Board (DSMB). We do have information about recruitment, and in an effort to give you the most up to date information, the following information is taken from NETT recruitment statistics compiled as June 30, 2000.
These Statistics are for all Centers:
Total started screening: 2588
Total ineligible patients: 1633*
Total patients randomized: 756
Total medical management: 380 (50%)
Total LVRS: 376 (50%)
*This is the total number of patients who were not eligible for rehab, either after screening, or became ineligible during rehab.

The Following Information is Specific to UCSD Medical Center:
Total started screening: 180
Total ineligible patients: 129*
Total patients randomized: 33
Total medical management:  16 (50%)
Total LVRS:  17 (50%)
*This is the total number of patients who were not eligible for rehab, either after screening, or became ineligible during rehab.
++++++++++++++++++++++++++++++++++++++
LETTER FROM LINDA FARRIS:
Dear Pulmonary Coalition:
I had a call today from my Congress-man's office. They are wanting information about the ruling from the ALJ.  The Congressman is going to call the chairperson of different committee's, like Health and Ways and Means to suggest that perhaps it is time to have a hearing on this situation. We seem to have their attention, so now is the time to write to both your senators and your representative.  Express your views of the unethical way the NETT study is being done.  Randomizing care iswrong.  Point out that under the current rules, poor people's health care is being rationed.  If one does not have the money to pay for the surgery, or the money to be able to travel and live at a NETT center for several weeks, perhaps months, then they have no opportunity for a chance at a better quality of life.
Sincerely,
Linda Farris

NETT STUDY

PLEASE READ: http://www.hhs.gov/oig/advopn/2000/ao00_5.htm

HCFA/NHLBI admits that they are having trouble getting applicants for the NETT study and now they try to get
exceptions to the rules to try and enhance their study.
The right thing to do, would be to just stop randomizing people health care.

CPPC

Subject:  Re: LVRS
Date:  Thu, 6 Jul 2000 16:55:41 EDT
From:  Zzzbony@aol.com
To:  pulmonarycoalition@yahoo.com

My reference to where I was five years ago came from the DR, who only read my charts, and without examination. However when he found out I had LVRS done he seemed more interested in talking to me and seeing me in person. So I take that as a good thing, not as a bad thing. I feel wonderful even though I have
some bad days, I am still able to have a quality life style. As for my breathing in comparison to right after LVRS, I am not as well as I was. I believe that my lack of exercise has caused this and my asthma which seems to be getting worse has a lot to do with my breathing also. I am going to wait till Aug 1st before committing to rehab as I want Dr. Wain to see these test results and I will go from there. I still am active and am trying to be more active as I find that and being busy is the key for me at this time. I only wish others that have had this surgery could say they had the same results. I believe most can if they do the rehab before surgery and continue to do the exercises. Marianne

From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

http://www.FRESNOBEE.com

Read this and then write to your senators and your representative.  The NETT study is wrong.

Medicare is randomizing peoples health care.  People who by law was required to pay for it.  It was done with payroll deductions and
you had no choice.

Medicare is not only randomizing health care they are rationing health care.  If one has the money to go to a NETT center they have a
50% chance of perhaps gaining a better quality of life.  If they have the money to pay for health care, they have the chance of gaining
a better quality of life.  What happens to those who cannot afford either of the above situtations?  I think  we all know.  We don't like
to think about it, but death is what they face, without ever having a chance at a better quality of life.  This is wrong.

Please take the time now to write and get all your friends and neighbors to write your elected members of Congress.

Remember this is an election year.  Every seat in the House of Representative is up for election as is a portion of the Senate.  Remind
them of this.  If this Congress cannot or will not deal with this issue, then we will work to elect a Congress that will.  Get them to
commit to a position on the NETT study and their views on randomized care.

There is ample evidence to show that LVRS is a safe procedure for the correctly chosen candidate.

Thank You,
CPPC


According to the American Thoracic Society article..vol. 154..1996,  these are the contraindications for LVRS:

1.  Age  75 and over
2.  Cigarette use within 3-6 months prior to surgery.
3.  Severe obesity or cachexia which is defined as a general weight loss and wasting occurring in the course of a chronic disease
or emotional disturbance.
4.  Severe comorbid illness or rapidly fatal medical illness.
5.  Severe pulmonary hypertension.
6.  Inability to participate in rehabilitation.
7.  Severe hypercapnia which is defined as abnormally increased arterial carbon dioxide tension.
8.  Ventilator dependence.

coalition Pulmonary <pulmonarycoalition@yahoo.com>

Since posting the article in the Riverfront Times, we have several letters.  This is a consensus of those letters.  Please take what information you can and communicate it to your two Senators and your Representatives.  Please feel free to add to or subtract from the information as it fits your individual situation.

We are finding it hard to understand  why HCFA/NHLBI contend HCFA cannot cover LVRS because of unknown
results and unknown benefits.   Our question is why is LVRS being held to a different standard?

If, indeed this is standard procedure that LVRS is being held to, then you must in all fairness hold all surgeries to the same standards. That is to say, if one has coronary bypass surgery, they will not need any other procedures to deal with clogged arteries.  We all know now that many patients have numerous procedures for this particular disease, coronary artery disease. We do not believe this practice should be started, the point is one of fairness to all patients whether it be coronary disease or pulmonary disease.

The article in the Riverfront Times, quotes people associated with the NETT study dispute that LVRS does benefit certain individuals.  Look at the success of Dr. Cooper. Use his protocol of patient selection, the problem would be solved.

Ms.Gail Weinmann admits that mixing together the results of the 711 cases instead of using only the ones that were using Dr. Cooper's methods was not fair.  Dr. Naunheim agreed HCFA/NHLBI mixed apples and oranges in compiling their data.  Dr. Griffin Trotter, a professor at SLU, at the Center for Health Care Ethics agreed that withholding treatment from viable candidates is unethical.  He says in essence that the study was poorly designed.  These are facts that HCFA/NHLBI cannot just sweep under the rug.  These questions must be answered. To the satisfaction of the public and Congress.

It is obvious, that the NETT study is a monumental failure.  You cannot recruit patients, you have spent hundreds of thousands, perhaps millions on a publicity campaign and the NETT study is still a failure. It is time for HCFA to place patient health care back in the forefront of their responsibilities.

Different NETT centers have badgered patients and harassed patients to enroll. One person was told she was not a candidate. When she became eligible for Medicare, THEY called her wanting her to enroll.  They enrolled her and scheduled her for tests without her knowledge or consent. HCFA must explain this.

Another NETT center, called a patient at least three times, AFTER she had told them she was not interested.  This
is harassment.  This must be made public for all to know the strong-arm tactics being used. This needs to be made public.

Another person went and was screened, tests were run and  they were told he was a candidate.   At the end of his rehab he went to be randomized.  Very nervous, fearing he would be randomized to medical, was totally shocked when the surgeon, refused to even randomize him.  They told  him he would never live through the surgery or if he did, he would be on a ventilator the rest of his life.  One of two things happened to that individual.  Some doctor wrote orders for his rehab. This doctor knew from his test results he was not a surgery candidate, but it was "easy money" for the hospital. The other possibility was  he did not look at the tests and order rehab that could have endangered this persons life.  In either case this doctor, this center is guilty of malpractice.  This must be brought to the attention of Congress.

For the reasons outlined above, we are asking for a Congressional Hearing on LVRS and the NETT study.  We it be public and enough notice given for people to attend.  We want testimony from people who have had LVRS, both as self pay and those that Medicare covered before January 1, 1996. We want  patient's who were harassed by phone calls be allowed to testify.  We want the person who went through the program and then the surgeon would not even randomize him to testify. I want each of them to be able to tell their story to the Congress and to the public. We want surgeons of Dr. Cooper's caliber be allowed to testify as an expert in the field of LVRS.

We want the public to know what the dollars they are paying into Medicare as mandated by law pays for.  I am sure many do know nor approve of HCFA employing a public relations firm.  The people need to know what Medicare is not doing providing health care to respiratory patients.

I want people to realize in reality, Medicare is rationing care.  You must have the money to pay for travel, food and lodging for several weeks at a Medicare NETT center, you have a fifty- percent chance of surgery.  A fifty- percent chance at a better quality of life.

 If one has the money and can pay for it, they have a chance at a better quality of life. They are not put into the stressful position of randomization.  The stress is that many have to spend the money they had planned on for their retirement.

What happens to the people who do not have the funds? COPD, Emphysema is a progressively degenerative disease, so that is what happens to them. They progressively deteriorate until they no longer have breath, and they die.  This is very sad, when the health care system they paid into abandons them.

The patient, who self pays, is left with an ordeal of appealing Medicare's denial of payment. This could lasts for months, before they have a hearing  before an Administrative Law Judge.  While this is time consuming and frustrating and stressful they can win.  During this time they do have "their improved quality of life."

The poor just wait for death.

We ask you  correct this injustice.  Do the right thing and have a study that offers care with compassion.  More centers would help.  These centers should be well staffed and well equipped.Continue to gather information  to determine who makes a good candidate.  Keep in mind, medicine is not an exact science.  You cannot guarantee
the same results to each patient, no matter what procedure is being performed.


Subject:  HCFA, Medicare, and NETT
CC:  pulmonarycoalition@yahoo.com

Emphysema (often called COPD) is estimated to be the third leading cause of death and of disability, in the US The cost (in private and public moneys) is staggering, both for treatment and in lost productivity. There are numerous treatments that have been proven to be very cost effective in arresting the course of this illness (one being lung volume reduction surgery [LVRS]), as well as contributing significantly to the quality of the patients' lives, yet Medicare (the pacesetter in reimbursement policy) refuses to recognize/authorize them. Congress needs to be better informed in these matters and more responsive to the needs of thousands of patients.

For many patients with COPD (Chronic Obstructive Pulmonary Disease) lung volume reduction surgery is the indicated treatment and has been proven effective, yet Medicare and HFCA persist in labeling it "experimental," denying many qualified candidates its benefits. Together with NIH and other "scientists," they created the NETT program that is proving to be a nightmare to administer and the source of several court decisions that are rather embarrassing to the federal government.

The NETT program is a politically motivated program that presumes to prove or disprove that which is already demonstrable fact. It is a waste of money and, worse, of human life. LVRS is a proven surgical procedure.

In the time that HFCA and Medicare have denied LVRS, some 7,000 people died because they were refused lung volume reduction surgery by Medicare and 16,000 more, because their HMO or insurer wouldn't authorize payment "because Medicare considers it experimental."

You should also realize that, during that same period, tens of thousands of patients were admitted to emergency rooms for episodes that could have been avoided by appropriate treatment that was not offered, and 100,000 work days and school days were lost by other patients and their caregivers. These problems cost us, collectively, several million dollars a day.

The treatment of COPD is not nuclear science. There are many drugs and rehabilitation treatments available, and more appear every year. Most are developed without government money.

But congress listens to the scientists who ache to spend money so they can write peer-reviewed papers, rave on about spending more on "basic research."  To those of us with COPD, you are, in effect, telling a drowning man that you are thinking about initiating another study of the tides.

I am asking that Congress act to utilize the knowledge in which it's taxpayers (and private patients) have invested heavily; I'm talking about applying that technology you so grandly attribute to our NIH, and; I'm suggesting we finally start treating patients with all the tools we have at hand.

If you would like more information, contact Pulmonary Coalition, at the address shown above, as a CC, or visit my website at http://members.aol.com/SOBnSA/home.index.html


Subjet:  random selection for lung surgery (LVRS )
To: PulmonaryCoalition@yahoo.com

I attended the NETT at the University of Washington in Seattle ,and went thru the necessary testing and rehab prior to Medicare's computer in Washingtom D.C. descision as to whether or not I would receive the surgery or continued Medical rehab.

I nervously awaited the randomization decision ,and much to my surprise and chagrin, I was told that LVRS was not in my future as the computer had selected several of us for medical.  WOW !! I did not know how to react as I had steeled myself for Surgery etc, etc.  I have been on maintenance since that time and am not able to keep up with the exercises here at home and honestly feel that LVRS would have been more beneficial for my health.
Sincerely   Dick Parchem


Date:  Wed, 26 Apr 2000 12:55:47 -0700 (PDT)
From:  coalition Pulmonary <pulmonarycoalition@yahoo.com>

Dear Members
This week, we got to read an article from Newsday.  This article told of a patient, Sam, a member of CPPC, and his struggle with Medicare.  He has received his part B but is still fighting for part A.  In recent weeks we had a letter from another member, Linda Farris, who told of the victory she and her husband had won in a decision from an Administrative Law Judge.  The judge ruled in favor of the patient for Medicare part A.  We recently got another
letter from Linda saying that the hospital had refunded their money.  Another person also has won his appeal for Medicare Part A. We applaud the victory of all parties.  They have had a long struggle, but "right" did prevail.
What do we need to do now?  We need to write our elected officials and say enough.  Medicare made a poor decision when they entered into a contract that randomized patient care. The low enrollment in the NETT study proves it is a failure. At the rate they are enrolling patients it will take years and years to complete the study.
The NETT study requires patients to travel long distances, which for many is impossible.  The NETT study requires one to spend from several weeks to several months at a NETT center, which many cannot afford.  The NETT study then randomizes 50% of the correcly chosen candidates to medical.  Which means they get to go home and do what they had been doing.  The bottom line is, LVRS is not possible  within  the NETT if one does not have the necessary funds to travel plus money for motels and meals.
There are now at least three cases of where a patient has appealed the non-payment decision for LVRS.  From now on it is not only being stressful for the patient to have to appeal the non-coverage decision; it is cases that HCFA is losing.  This takes up time of the court and the time of HCFA workers to try and defend what is indefensible.
Now is the time for the NETT study to stop. Let all those who are deemed to be a good candidate have the surgery.  You need to make this clear to your members in Congress. We do have power at the ballot box.  Each person in the House of Representatives is up for re-election as are certain members of the Senate.  Ask them for their opinion as to whether this should be a covered benefit. Remind them of cases that have been appealed and won.  Insist they make a statement either for or against stopping the NETT study.  Remind Congress that patients should not have to go through this kind of stress and harassment to secure medical care, as prescribed by their physicians.  Medicare is a benefit that they have bought and paid for through payroll deductions.  It is now time for Congress to take the necessary action to secure these rights for everyone, including respiratory patients whose physicians prescribe LVRS.
We, at CPPC do lobby your elected officials in Congress.  You, too should write your personal letter describing your feelings.
Thank You,  CPPC

Subject:  LVRS
coalition Pulmonary <pulmonarycoalition@yahoo.com>

GRAY MATTERS / Medicare's OK, and You?
PUBLICATION: Newsday
BY: Saul Friedman
EDITION: NASSAU AND SECTION: Part2
DATE: 04-21-2000

ALL OF US should celebrate the news from Medicare's trustees that the nation's health care program for older Americans is in better financial shape than had been thought. Maybe lawmakers who oppose any form of government health insurance will have less excuse to reform it to death.  It could also mean that Medicare has been saving money on the backs of beneficiaries, by cutting payments to nursing homes, restricting access to home health services and practicing the sort of managed care we've come to expect from insurance companies.  Medicare advocates contend that doctors, hospitals and patients increasingly complain that Medicare has refused coverage for a range of medical treatments and potentially life-saving diagnostic and surgical procedures that it deems "experimental" or "medically
unnecessary." Medicare rightly seeks to control fraud and protect patients against unproven, unapproved treatments through its "national coverage determinations," a voluminous set of technical rules in its manual, governing what it
will and will not pay for. But because medicine is changing rapidly, and Medicare cannot afford some of the new techniques, patients may suffer.  Consequently, Medicare's refusal policy and its national coverage determinations have been challenged in a potentially important suit recently filed in a Texas federal court by the Connecticut-based Center for Medicare Advocacy on behalf of Sammie Richey, 71, of Waco, a retired aerospace worker who has emphysema.
Richey, who has been disabled by the incurable respiratory disease since 1990, had been unable to do simple household chores or play with his grandchildren, and he was literally tied to his portable oxygen bottle. But on March 25, 1997, after testing and pulmonary rehabilitation, Richey underwent a new surgical procedure that his physician called "medically necessary"-the removal of the most diseased parts of his lungs.  The procedure, called lung volume reduction surgery (LVRS), is the subject of a seven-year Medicare study begun in 1997. Medicare also ruled in 1997 that LVRS "is not generally covered." That remains the rule, although hundreds of patients like Richey may be helped by the surgery. Within weeks after surgery (no longer rare), Richey was taken off oxygen for normal
activities, and he is able to participate in community and family functions as well, his legal brief says.Richey's surgery would have been covered if he had been part of the Medicare study, but he wasn't. So Medicare wouldn't pay his $4,000 Part B doctor bill until he won an appeal last year. Medicare still won't pay his Part A hospital bill, more than $54,390, and has denied his right to appeal.  Curiously, in a case just a few miles from Waco, Medicare has paid the Part A bill of a man who underwent the same surgery but is refusing to pay the smaller Part B costs. The contradiction, worthy of an HMO, prompted the suit, which could provide relief for thousands of enrollees who have been denied coverage for the treatments and operations they need. Sally Hart of Tucson, Ariz., one
of the attorneys for the Center for Medicare Advocacy, told me, "We're hoping it [the suit] will have a wider impact and challenge a long list of procedures that Medicare considers medically unnecessary."
On a related subject, Raymond D. alerts us by e-mail "about a problem disenrolling from an HMO." He says that when he notified Aetna he was disenrolling to return to traditional Medicare, the company delayed his disenrollment for a month. As a result, he wrote,  "I am left without insurance. I would advise anyone seeking to leave an HMO do it by going directly to Medicare."  The New York-based Medicare Rights Center says beneficiaries risk coverage gaps if they move from one Medicare HMO to another managed care insurer. Here's how to avoid such gaps: "If the Medicare HMO receives the disenrollment documents before the 10th of the month, new coverage begins the first of the following month. If the Medicare HMO receives it after the 10th, the new coverage is not effective until the first day of the second month." Moving from an HMO back to traditional Medicare is safer, says the center, adding that "there is absolutely no lapse in coverage." Even so, send your disenrollment letter to the Medicare HMO by certified mail, return-receipt requested, then go to the Social Security office to fill out HCFA form The 73-year-old man walked into Maria Dixon's office, Selfhelp Maspeth in Queens, with a problem that is becoming too common.
He had no health insurance except Medicare. And he had just been told he has colon cancer. He asked whether he could buy a Medigap policy to help pay the cost of his terrible illness. The Washington-based Employee Benefit Research Institute says the number of Medicare beneficiaries with no supplemental Medigap insurance has grown by a third in the last four years, to 9.2 million people.  That's almost 25 percent of the 40 million people on Medicare, and they're living at the edge of catastrophe because they can't afford or qualify for a Medigap policy.  In most states Dixon's client would have been out of luck, for in general, Medicare beneficiaries who have been in the program longer than six months are entitled to open enrollment to buy Medigap policies (assuming they can afford the high cost), regardless of pre-existing health conditions, only after they've lost their private coverage.  But in New York State, enrollment for supplementary insurance is always open, says the Medicare Rights Center, so Dixon's client,
or any New Yorker, has the right, at any time, to buy any of the several Medigap policies offered regardless of any pre-existing condition. But insurers usually require a six- month waiting period before the policyholder makes a claim in connection with the pre-existing condition.  Although one company told Dixon it would not impose a waiting period on her client, the colon cancer patient chose not to wait six months for his surgery, much of which will be covered by Medicare. If some of this information is news to you, the nonprofit Medicare Rights Center, '0 Broadway, 11th floor, New York, N.Y. 10036, has a Medicare Survival Kit, including new "Medicare Changes, Medicare Choices," for $25 plus $4.75 for shipping.

Subject: LVRS
From: coalition Pulmonary <pulmonarycoalition@yahoo.com>
HIS IS A MESSAGE WE JUST RECEIVED FROM ONE OF OUR MEMBERS. HOPEFULLY THIS ARTICLE WILL HELP EDUCATE PEOPLE ABOUT RESPIRATORY PROBLEMS AND THAT THERE IS A VIABLE PROCEDURE
FOR THE CORRECTLY CHOSEN CANDIDATE.
*************************************************
This is a follow up to a previous article titled "The News is in Washington, D.C. I was interviewed by a Newsday journalist who has written an article on the Medicare case that I have appealed and is now in Federal District Court.  What is in the article, I do not know because I did not see the draft before it is being published. The article will be on Newsday web site April 22. Go to
http://www.newsday.com When the home page comes up, click on "current editions" in the upper lefthand corner and choose
Part 2. When it comes up, scroll down to the column, which is entitled "Gray Matters" and click on the blue hypertext
********************
THANK YOU SAM FOR SHARING WITH US. CPPC
From:   KUFarris2@aol.com

Good Morning Olivija:

Other good news is there is going to be a program on PBS in May that will feature Dr. Cooper with Jim as his patient.  Don't
know the exact date for airing,  the program is called Healthweek.

Our local Fox station is coming out today to interview us about the appeal.  I hope something good comes out of this for others.

Thanks so much for your nice words.

Linda

From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

WE HAVE RECEIVED TWO MORE LETTERS SUPPORTING CPPC'S GOAL TO STOP RANDOMIZING
PATIENT CARE.

THESE ARE VERY DIFFERENT LETTERS.  ONE SHOWS THE IMPACT OF MEDICARE'S DECISIONS  WITH PRIVATE INSURANCE.  THE OTHER SHOWS THE HOPELESSNESS OF BEING RANDOMIZED TO MEDICAL.

WE ASK YOU TO SUPPORT THESE LADIES AND THEIR GOALS TOO.  STOP NOW AND WRITE YOUR TWO SENATORS AND YOUR REPRESENTATIVE.  TELL THEM YOUR VIEWS ON LVRS AND THE NETT STUDY.

ONCE AGAIN, WE ARE RESPECTING THE PRIVACY OF THESE INDIVIDUALS AND NOT INCLUDING THEIR EMAIL ADDRESSES.  THEY DO NOT WANT TO SHARE THEIR ADDRESS TO THE HUNDREDS WHO GET THIS LETTER.  WE HOPE YOU CAN UNDERSTAND THEIR POSITION.

WE ALSO HOPE YOU UNDERSTAND OURS IN PROTECTING THEIR PRIVACY.  WE TELL THEM IF THEY ALLOW THEIR LETTERS TO BE SHARED WE WILL RESPECT THEIR WISHES OF PRIVACY.

THANK YOU, - CPPC

*************************************************************
Subject: Support for CPPC
To: PulmonaryCoalition@yahoo.com

I suffer from severe emphysema and am currently in a battle with a private insurance carrier to pay for LVRS.  The position taken by the NETT program hurts everyone, not just Medicare patients, because private carriers use the NETT protocol as an excuse not to pay.  I will have the surgery done anyway and will self-pay and fight later.

I am willing to support this coalition in any way I can to help ensure that pulmonary patients can get the medical help they so desperately need and deserve.

Sincerely,
Anne
*************************************
<pulmonarycoalition@yahoo.com>
Subject: Fw: National Emphysema Treatment Trial

MR. Rockefeller,   I am writing to you to see if you can help in stoping = the Randomization of Emphysema patients. by Medicare. in the Emphysema = Treatment Trial.  I was Randomized to Medical Treatment after Months of = test and traveling many miles for treatment and being lead to believe  = surgery would help me. And that I would be a good surgery risk  This is = a very Cruel and discriminatory practice. no other disease is treated = this way.  Please help stop this trial so all Patients that need this = surgery may have it   Thank you Ruth

From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

We, received a letter from Linda F and she tells us that they have received word from Medicare that they will not appeal the Administrative Law Judges decision.  When all the paper work gets done between the hospital and Medicare, their money for Medicare Part A should be refunded.

We were told this is a fight that has been going on for 4 years.  Letters were written for almost two years when Medicare withdrew funding for LVRS.  The last two years writing letters concerning the appeal.

It shows that persistence  does pay.

From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

Please write to anyone you know in Health and Human Services, NETT, HCFA or Medicare to urge them to allow the LVRS surgery for ALL qualified candidates. I would like to help you in this effort, so please contact me by e-mail me (.) for any additional information. I will be glad to describe my success in more detail.
**************

The above was the last paragraph of a letter that we mailed to our membership.  The person who wrote the letter was writing to her elected senators and representative.  It was to them that she said to contact her for more information.  When she agreed to let us use her letter he Email was removed so that it would not go to the hundreds of people who receive our mailings.

We apologize for not making this clear in the original letter.  We feel we must respect her right to privacy and her not wanting her Email spread around to such a large group.  Again we apologize for this misunderstanding.

CPPC
From:  coalition Pulmonary <pulmonarycoalition@yahoo.com>

WE THOUGHT THIS WAS NEWS OF INTEREST TO ALL OUR MEMBERS.
*************
Pioneer Surgeon Addresses 'Heartbeat 2000'

A pioneer surgeon in lung transplants, Dr. Joel D. Cooper, was in Olathe Friday to address the Olathe Medical Center's second annual "Heartbeat 200" cardiology conference for primary care, internal medicine, emergency and cardiology physicians.

Cooper--cardiothoracic surgeon in-chief at Barnes-Jewish Hospital in St. Louis, Mo,--headed the team that performed the world's first successful lung transplant in 1983 in Toronto; in 1986, the same team did the world's first successful double lungtransplant.

In January 1993, Cooper was a member of the team that performed the first lung volume-reduction surgery.  Since then, he has performed more than 300 lung volume-reduction surgeries for patients with severe emphysema.

The noted surgeon is developing a new procedure, which will be available to more emphysema patients, to create new pathways to get air out of the lungs.

A local success vs. Medicare

A Cooper patient who's had the lung volume-reduction surgery, Jim Farris of Overland Park, was at Friday's conference, accompanied by his wife, Linda.

Farris paid for his May 1998 surgery because Medicare won't pay for the procedure.  "It was either [pay for it) or die," he said.

The Farrises on March 7 won an appeal before an administrative law judge, to require Medicare to pay for the surgery, according to Linda Farris.

However, Medicare can appeal the decision.  This is the third case to reach this point, and the two previous cases Medicare has appealed were thrown out, Cooper said.

If Medicare would win an appeal, Linda said, the Farrises have one more step--federal court.

"I'd love to go to federal court," said Cooper, who opposes Medicare's stance of not paying for the surgery.  He has testified before the U.S. House of Representatives' Ways and Means Committee on this issue.

Farris said the surgery drastically improved his life, "The best way to describe it," he said, "is before the surgery, I could barely walk across my yard on Oxygen. Now, I'm raking my yard without oxygen."

Cooper estimated that between 25 and 30 hospitals across the United States offer lung volume-reduction surgery.  However, when the first such surgery was reported at a New York conference in 1994, it had widespread application and many hospitals started doing it.

While Cooper's hospital in St. Louis had the special surgical team, he said there was "flagrant abuse" of the surgery in other hospitals, which ultimately led to Medicare no longer funding the surgery in September1995, with only a two week notice.

Consequently, most private insurance companies continue to fund the operation, he added.

Meanwhile, a Medicare-established trial isn't going very well, according to Cooper.  Barnes-Jewish Hospital has opted to not participate in the trial, because the staff would have to tell half the surgical candidates they couldn't have the surgery.

A big advantage of the lung volume surgery, compared to transplant, is that it can be performed on older patients.  The upper age for a lung transplant is 63. Also, there's no waiting for a donor for the lung volume reduction.

But lung volume reduction isn't for everyone with emphysema, the surgeon said, and only about one in five are suited for it. The surgery isn't a cure; it's just a step to try and turn back the clock, he added.

Lung Transplants:
Barnes-Jewish Hospital has had the largest and most successful lung transplants in the world, Cooper said.  More than 700 lung transplants have been performed at the hospital since July 1988.

There were 44 consecutive failures for the lung transplants, starting in 1963, before the first successful one by the team, led by Cooper, in 1983 in Toronto.  The same team had a failure in 1978, when complications arose with the airway connection, said the surgeon.

Tom Hall, the first person to successfully have a lung transplant, died of kidney failure more than five years after the transplant.

"He was a very brave person," Cooper said, "We couldn't have asked for a more wonderful person."

Hall had had a slow recovery, the surgeon said.  After three weeks, he had to have two nurses drag him down
the hall.  He had a new lung and couldn't do anything,  Cooper had thought then.  The problem wasn't with his
lungs but with the rest of his body, doctors discovered.

The team learned an important lesson about conditioning patients to physically handle the exercise their lungs would allow--also true for patients who underwent lung volume-reduction surgery, according to Cooper.

Today, the five year survival rate for lung transplants is in the 50 percent range, he said.

From:  coalition Pulmonary <pulmonarycoalition@yahoo.com>

THIS IS A LETTER WE RECEIVED A SHORT TIME AGO, FROM ONE OF OUR MEMBERS.  WE THOUGHT IT EXPRESSED THE SENTIMENTS OF PEOPLE WHO HAVE RECEIVED LVRS VERY WELL.WITH HER PERMISSION, WE ARE SHARING IT WITH OUR ENTIRE MEMBERSHIP.  AS YOU CAN SEE SHE HAS WRITTEN HER ELECTED OFFICIALS AND WE URGE YOU TO DO THE SAME. IT MAKES NO DIFFERENCE IF YOU ARE A PATIENT OR HAVE A FRIEND OR LOVED ONE SUFFERING FROM EMPHYSEMA. WE HAVE OMITTED HER NAME AND ADDRESS TO PROTECT HER PRIVACY.

THANK YOU, - CPPC

*******************
In January 1998, I was an emphysema casualty, housebound forced to use a wheelchair and attached to an oxygen tube 24 hours a day, seven days a week.  Today, I breathe on my own, freely of those oppressive limitations on the quality of my own life, as well as that of those around me. The source of this miraculous recovery was LVRS, Lung Volume Reduction Surgery.  The operation which transported me from such hopelessness back to a new level of health was performed only a few month ago.

There are ,two purposes for my desire to share my gratifying experiences with those who suffer from this debilitating disease: First, I want to describe my journey from weakness to strength, with the hope it will serve as both inspiration and information for other victims; Second, I want everyone who is or knows an emphysema sufferer to encourage the National Emphysema Treatment Trial (NETT) to, discontinue its randomization process, which allows life-giving Lung Volume Reduction Surgery to only, half of the qualified candidates, resulting in a cruel and discriminatory practice

Let me explain under the auspices of the Health Care Financing Administration (HCFA), evaluates emphysema.
Let patients for LVRS, determining whether a patient is physically and emotionally able to endure the surgery. I was, accepted as a viable candidate in January 1999. The procedures set up by NETT determined that the assignments were to be made through a random selection process in which only half the group was eligible for both medical rehabilitation and LVRS; the other half would receive only medical rehabilitation.'

On the basis of a computer-generated random selection, I was denied the surgery! For the next few months, my
condition continued to deteriorate. In September 1999, my husband and I resolved to purchase the surgery ourselves, the best financial decision we ever made.  The amazing and gratifying result of the surgery is nothing short of a miracle, enabling me to move about my house, hug my grandchildren, attend the theater, have dinner in restaurants, fly in an airplane and look forward to a life full of hope instead of despair.

I will forever be grateful that we had the resources to self-pay for LVRS, but my heart aches for those 50% who do not have the money. Does a computer have the right to deny a life-giving opportunity to people who also qualify for this miraculous surgery, but do not possess the financial means to pay for it privately? Are they to be denied a chance for a satisfactory life just because they are poor? This randomization process must stop

Please write to anyone you know in Health and Human Services, NETT, HCFA or Medicare to urge them to allow
the LVRS surgery for ALL qualified candidates. I would like to help you in this effort, so please contact me by e-mail me (.) for any additional information. I will be glad to describe my success in more detail.

From: KUFarris2@aol.com

Pioneer Surgeon Addresses 'Heartbeat 2000'

A pioneer surgeon in lung transplants, Fr. Joel D. Cooper, was in Olathe Friday to address the Olathe Medical Center's second annual "Heartbeat 200" cardiology conference for primary care, internal medicine, emergency and cardiology physicians.

Cooper--cardiothoracic surgeon in-chief at Barnes-Jewish Hospital in St. Louis, Mo,--headed the team that performed the world's first successful lung transplant in 1983 in Toronto; in 1986, the same team did the world's first successful double lung transplant.

In January 1993, Cooper was a member of the team that performed the first lung volume-reduction surgery.  Since then, he has performed more than 300 lung volume-reduction surgeries for patients with severe emphysema.

The noted surgeon is developing a new procedure, which will be available to more emphysema patients, to create new pathways to get air out of the lungs.

A local success vs. Medicare

A Cooper patient who's had the lung volume-reduction surgery, Jim Farris of Overland Park, was at Friday's conference, accompanied by his wife, Linda.

Farris paid for his May 1998 surgery because Medicare won't pay for the procedure.  "It was either [pay for it) or die," he said.

The Farrises on March 7 won an appeal before an administrative law judge, to require Medicare to pay for the surgery, according to Linda Farris.

However, Medicare can appeal the decision.  This is the third case to reach this point, and the two previous cases Medicare has appealed were thrown out, Cooper said.

If Medicare would win an appeal, Linda said, the Farrises have one more step--federal court.

"I'd love to go to federal court," said Cooper, who opposes Medicare's stance of not paying for the surgery.  He has testified before the U.S. House of  Representatives' Ways and Means Committee on this issue.

Farris said the surgery drastically improved his life, "The best way to describe it," he said, "is before the surgery, I could barely walk across my yard on Oxygen.  Now, I'm raking my yard without oxygen."

Cooper estimated that between 25 and 30 hospitals across the United States offer lung volume-reduction surgery.  However,when the first such surgery was reported at a New York conference in 1994, it had widespread application and many hospitals started doing it.

While Cooper's hospital in St. Louis had the special surgical team, he said there was "flagrant abuse" of the surgery in other hospitals, which ultimately led to Medicare no longer funding the surgery in September 1995, with only a two week notice.

Consequently, most private insurance companies continue to fund the operation, he added.

Meanwhile, a Medicare-established trial isn't going very well, according to Cooper.  Barnes-Jewish Hospital has opted to not participate in the trial, because the staff would have to tell half the surgical candidates they couldn't have the surgery.

A big advantage of the lung volume surgery, compared to transplant, is that it can be performed on older patients.  The upper age for a lung transplant is 63.  Also, there's no waiting for a donor for the lung volume reduction.

But lung volume reduction isn't for everyone with emphysema, the surgeon said, and only about one in five are suited for it.  The surgery isn't a cure; it's just a step to try and turn back the clock, he added.

Lung Transplants: Barnes-Jewish Hospital has had the largest and most successful lung transplants in the world, Cooper said.  More than 700 lung transplants have been performed at the hospital since July 1998.

There were 44 consecutive failures for the lung transplants, starting in 1963, before the first successful one by the team, led by Cooper, in 1983 in Toronto.  The same team had a failure in 1978, when complications arose with the airway connection, said the surgeon.

Tom Hall, the first person to successfully have a lung transplant, died of kidney failure more than five years after the transplant.

"He was a very brave person," Cooper said, "We couldn't have asked for a more wonderful person."

Hall had had a slow recovery, the surgeon said.  After three weeks, he had to have two nurses drag him down the hall.  He had a new lung and couln'd do anything, Cooper had thought then.  The problem wasn't with his lungs but with the rest of his body, doctors discovered.

The team learned an important lesson about conditioning patients to physically handle the exercise their lungs would allow--also true for patients who underwent lung volume-reduction surgery, according to Cooper.

Today, the five year survival rate for lung transplants is in the 50 percent range, he said.


Subject: Medicare Appeals for LVRS
From: coalition Pulmonary <pulmonarycoalition@yahoo.com>
CPPC NEWS:

We just got a letter from one our members.  Sam has been involved in appealing Medicare's decision of nonpayment for LVRS. He had surgery 3 years ago.

He has had a resolution of his Medicare part B. the Administrative Law Judge ruled in his favor and it was upheld by the Appeals Council.  His appeal for Medicare part A is in court now.

Two others are in a similar position.  One is a member of CPPC.  One case, involving Medicare part A the Administrative Law Judge ruled in his favor and Medicare part A has paid.  The other, a member of CPPC has had an Administrative Law Judge rule in his favor, their claim regarding Medicare part A; they are now awaiting review.

This is good news for our cause, which has been to stop randomization.

There is more good news to share.  NewsDay magazine has contacted Sam and plan to do an article on Medicare not funding procedures that are prescribed by their physician's.  We are glad that recognition is finally being given to the plight that HCFA left respiratory patients in when they withdrew funding for LVRS.  When we find out when the article will be published, we will let you know.  We feel each of you will want to read it.

Congratulations to Sam on winning his Part B appeal. Congratulations on being selected to help with an article for NewsDay.

Congratulations to our other member who has received a favorable ruling for his case involving Medicare part A.  We hope they to receive word that the Administrative Law Judges decision will be upheld.

We ask each of you to now write your senators and representative. Tell them your views on randomization.  Tell them they have the means to stop it.  They can either pass a bill approving LVRS as a viable procedure, or they can with hold funding HCFA until HCFA makes the necessary changes in the coverage for LVRS.

Thank You  CPPC

Subject:  Administrative Law Judge's Ruling
From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

NEWS BULLETIN:

We have just gotten a letter from two of our members. Jim and Linda Farris.

Jim had LVRS in May 1998.  He had grown weary ofwaiting for Medicare to come up with something that would be available to everyone.  When he made his decision to go for the surgery as a self-pay patient, only 3 centers had approved the NETT protocol. His fear was he would become too ill for the surgery.  That fear almost became a reality, when one day prior to his scheduled departature date to go to St. Louis, he became quite ill and had to be hospitalized and the surgery postponed and had to be rescheduled.

The second surgery date was May 19, 1998.  His success has been fantastic.  His doctors can not believe the improvement in his quality of life.  He is now off of O2 and doing anything a normal 64-year old man would do.

Immediately following surgery, Jim started to appeal Medicare's nonpayment decision.  He had a hearing before an Administrative Law Judge and has gotten the ruling.  The judge ruled in his favor.  Medicare can appeal, but this is an important step in the appeals process.

What can each of you do?  You need to write each of your elected officials and tell them to stop the randomizing of patient care. You need to write Medicare and express the same thought.  You do have the right to appeal Medicare decisions.  Take control of the situation to best of your ability and write to Congress.  Write to the various committees that might influence the spending of government funds.  Write to committees that deal with health issues.  Demand a public hearing on the randomizing of patient care. Demand a hearing on how Medicare picks and chooses which illness or procedure they will cover.

I don't want anyone to be misled.  LVRS is not a cure; it is a bridge to a better quality of life.  We would not want anyone to think that because Jim has gotten a decision from the Administrative Law Judge that was favorable, that you would get the same decision. Each case must be judged on its own merits.

Thank You, CPPC

Subject:  Re: [COPD] pulmonary studies.....medical ethics
Date: Wed, 1 Mar 2000 12:19:43 EST
From:  Bill Horden <SOBnSA@AOL.COM>

I'm content to leave the subject of "ethics" to those wiser than I, but the NETT approach does seem to fly in the face of common
sense when it offers a 50-50 chance to those who qualify, then expects the folk who are "randomized out" to passively accept their
fate. The patients who can afford it are going to get LVRS at their own expense, those who can't will stay with the program for a
while, participate in their second round of pulmonary  rehab (maybe), then get back to their former lives.

This means that the "randomized" group will contain far fewer than the required 50% and will have received significantly different
treatment than planned, or will have changed addresses and be unavailable for inclusion in the "outcome" report.

NETT is the only time the federal government has attempted to regulate the development and refinement of a new medical/surgical
procedure: it was foolish in its origin and design, poorly executed, inordinately expensive to conduct, and of virtually no "value"
when completed (because so few of the randomized control group can be assessed). The PhDs and civil servants in NIH and
HCFA will label it "inconclusive" and we'll be right back where we started.

The only one who will emerge from the NETT experience with any professional growth will be the good Dr. Cooper, who flatly
refused to participate in such a limited, ill-advised "study."

Bill Horden

Subject: Re: [COPD] Nett LVRS
Date: Wed, 1 Mar 2000 10:53:00 EST
From: Esther Ziegler <EZ1261@AOL.COM>

I would think that there are enough people out there that have been doing rehab and state of the art medications to let doctors
know whether they have improved enough to get off of O2. I myself went through 2 years of rehab and was doing 3.5 mph on the
treadmill for 1 hour each day. It didn't do one darn thing to improve my Fev1 or my need for O2. After I had LVRS my Fev1
improved from 29% to 90%. I was able to get off some meds including O2. It has been 4 yrs since surgery and I still feel better
that I did and I haven't lost any ground and most important, I haven't been sick. The one thing that NETT doesn't explain is that
the one surgeon that opted out of the study and was primarily responsible for bringing this surgery back, never advocated that
this surgery was for EVERYONE. The NETT study knows this and by including people they already know are not good candidates,
they skew the study to show exactly what they want it to. MEDICARE DOES NOT WANT TO PAY FOR THIS SURGERY.
With 13 million patients and 10% eligible for surgery is not something they want to deal with. In the end it's money that does the
talking. Those that have it will live better and those that don't won't.

Esther Ziegler

Subject: LVRS
Date: Fri, 8 Oct 1999 08:00:16 -0700 (PDT)
From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

It has been brought to our attention that HCFA is not telling Congress or Medicare beneficiaries the truth.  HCFA has been telling
us that the Center for Health Care Technology recommended a randomized clinical trial for LVRS.  We wrote HCFA and asked
for a copy of the report from CHCT in which a randomized trial was recommended.  HCFA did send us a booklet, titled Number
10, Health Technology Assessment, Lung-Volume Reduction Surgery for end-Stage Chronic Obstructive Pulmonary Disease.

We have read this booklet cover to cover and no where does CHCT recommend randomizing.  This is a big deal because
randomly excluding qualified surgical patients from LVRS seems unethical.

In the booklet they give data and opinions from 27 institutions. Most of the 27 institutions did not make a recommendation
concerning randomizing.  That would indicate they did not feel randomization was the best method to study LVRS.

The following institutions suggested a controlled study:

1.      The Harvard Medical School, Deaconess Hospital
2.      The California Thoracic Society

There is a difference in a controlled study and a randomized study.  In a controlled study, LVRS can be limited to approved
centers.  LVRS can be limited to those deemed a candidate by the doctors at those centers.  At no time have we ever been in favor
of not having limitations on LVRS.  It is important to keep this procedure in the hands of skilled surgeons and at medically elite centers.
This can be accomplished without randomization, which requires a "coin flip" to determine whether an emphysema patient will get
LVRS.  If the patient loses the "coin flip" then she gets to stay in pulmonary rehab which produces very little, if any, improvements
for the patient.  By comparison, a controlled trial could be accomplished by letting all candidates have surgery and then having all
data compiled and sent to a coordinating center to keep track of data from all institutions.  The data could be analyzed and correct information would then be  available to all surgeons and hospitals.  This could be called coverage with compassion.

The present protocol for the NETT does not offer any compassion for the patient.  Many demands are made. They are asked to
travel long distances, which may be a burden, physically.  They are ask to stay in motels, which for many is a burden financially.
They are then randomized, which for many is an emotional tragedy. Their only hope has been taken.  You must realize that for the
great majority, they have all ready been in rehab and are taking medication.  Surgery is the only alternative to what they have been
doing.  It is emotionally devastating to have your chances of a better quality of life snatched away, by being randomized.

We would suggest you write your Senators and Representative and ask for them to read the report.Ask that their office to get a
copy of this report and read it very carefully and they too, will see CHCT does not recommend randomization.  Read the Summary
and Conclusions and they will note that nowhere does it recommend randomization.  It is misleading for HCFA to continue to say
CHCT recommends randomization, when in the Summary and Conclusion section of the document, it never suggests randomization.
 It suggests there are unknown facts concerning LVRS, which would suggest they felt some sort of a controlled study
would be appropriate.  A controlled study is not a randomized study.  Make sure your Senators and Representative are aware
there is a difference.  The difference is some are offered a chance at a better quality of life. Some are sent hope with no hope.  All
hope has been taken, just by the flip of a coin.

We think it is time for us to become involved.  HCFA is putting out information, which they either can't or won't back up with
documentation.  We cannot accept this kind of reporting of what is supposed to be factual information?  Congress and the American
Public are both being fooled by language and statements that do not seem to have factual documentation.

January 1996 HCFA made a decision that LVRS would not be a covered benefit.  It took almost 2 years to come up with what we
 now know as the NETT study.  That study has never gotten off the ground.  This opinion is backed up by the fact that in June 1999, HCFA/NHLBI started an aggressive campaign spending millions of dollars to recruit patients to be screened.  This should tell you
that the NETT study was an ill-conceived idea.

Now in 1999 and the year 2000 there is new news about Emphysema.  In 1996 when HCFA stoped funding LVRS, Emphysema
was the fourth leading cause of death in the United States. Emphysema is now listed as the number three cause of death in the
United States.

They should stop randomizing and they should make more centers available for LVRS.  Travel and expense are two very big
problems facing people with Emphysema, most of who live on a fixed income.

Another issue that our elected officials need to address is the appeals process for Medicare patients. Right now in Congress a
Patients Bill of Rights has passed in the House of Representatives. The Senate has passed the Patients Bill of Rights.  Now the
two need to work out the differences.  The bill passed by the House of Representatives gives an appeal process and a legal remedy
for not getting appropiate health care.

We feel these same right should be afforded to Medicare patients as well.  Under the present rules, if Medicare makes a national
coverage decision, then there is no effective appeal process available.  Even if an appeals committee or an Administrative Law
Judge were to rule in the patients favor, HCFA still would not have to pay. This needs to be changed.  All Medicare patients
deserve the right to a fair appeal process.      CPPC

Subject: Dr. Joel Cooper - page 1
Date: Wed, 29 Sep 1999 13:28:44 +0000
From: Judith L Amerman <judya1540@juno.com>

DR. JOEL COOPER
Cooper broke lung transplant barrier

Joel Cooper, M.D. the revered lung transplant surgeon rattles off the patient's name and transplant date as if it were yesterday.
"Tom Hall. November 7, 1983."

Doctors and their medicine could offer little hope for Hall, a 58-year old Canadian hardware executive who was dying of a
progressive lung disease called pulmonary fibrosis.  He lived confined to a wheelchair and tethered to an oxygen tank.

Hall needed a new lung.  but at a time when surgeions regularly were transplanting hearts, livers and kidneys, no surgeon
successfully had broken the lung transplant barrier.

When Cooper, then head of thoracic surgery at the University of Toronto, told Hall that only 44 lung transplants had been attempted
worldwide and none of the patients lived more than a few weeks, Hall eagerly responded, "I'm grateful to have the opportunity to be

Number 45," Cooper recalled.

Lung transplant patients who made it through the tedious surgery routinely ran into fatal trouble several weeks later when their
airway connections stubbornly refused to heal.  Cooper and his co-workers retreated to the lab to find out why.  The airway
problem was thought to be a sign of organ rejection but Cooper wasn't so sure.

In a series of experiments, Cooper removed one lung from each of several dogs and then gave the lung back to the same dog from
which it came.  The airway connections healed normally.  But when he gave the dogs prednisone, an anti-rejection drug commonly
prescribed in high doses to stem the tide of invading immune cells, the airway connections fell apart.

Prednisone, a steroid, stops the inflammation crucial to wound healing, Cooper noted.  When cyclosporine, a more powerful
anti-rejection drug, became available in 1983, Cooper demonstrated that it could be substituted for prednisone without the adverse
airway effects.  With the airway problem solved, Cooper was ready to give lung transplants another try.

So, on the night of November 7, 1983, in a surgery led by Cooper, Hall received his transplant.  Several weeks later, while Hall
was still in the hospital, Cooper got a phone call he had hoped would never come. Hall appeared to have developed an air leak in
the new lung -- a sign that the airway connection was failing.

Subject: Dr. Joel Cooper - page 2
Date: Wed, 29 Sep 1999 13:28:27 +0000
From: Judith L Amerman <judya1540@juno.com>

"My heart absolutely sank," Cooper recalled.  "We had worked for years on that problem and if we were going to lose him, I didn't
want it to be from an airway complication.  That would have set us back very badly."

When Cooper examined Hall a short time later, he was relieved to find the airway connections intact.  A small air pocket had
broken on the surface of Hall's transplanted lung, but the condition was not serious.

"It was one of those situations where you are afraid to hope," Cooper said.  "You don't allow yourself to imagine that the transplant
 is going to be successful because you don't want to be too disappointed."

Hall beat the dismal lung transplant odds.  He returned to work several months after his surgery and lived for seven active and
enjoyable years before dying of kidney failure.  Cooper was credited with performing the world's first successful single lung
transplant.

Developing a world-renowned transplant program

Cooper, who now is the Joseph C. Bancroft professor of Surger and head of the section of general thoracic surgery, left Toronto in
1988 to establish a lung transplant program at Washington University.  Shortly after his arrival in St. Louis, he performed the world's
first successful double lung transplant.  The procedure involved transplanting two lungs into one patient and offered the first glimmer
of hope for Cystic Fibrosis patients who suffer from infections in both lungs.

Today, many patients who otherwise would have died from end-stage lung diseases are benefitting from lung transplants.  Lasy year
alone, some 700 patients in the United States received lung transplants.  Seventy-six of these surgeries were performed at Barnes
and St. Louis Children's hospitals.

Cooper's vision and drive for excellence helped him to crate the School of Medicine's world renowned lung transplant program.
The program, now headed by Cooper's colleague, Alec Patterson, M.D., professor of surgery, enjoys an unprecedented 94
percent success rate.

"Part of the success of the lung transplant program at Washington University is directly due to the program Joel Cooper develped in
Toronto," said Patterson, who followed Cooper from Toronto to St. Louis. "Joel is incredibly bright and energetic, and extremely
generous with his time and ideas.  He recruited top people here and insisted upon having the specially trained staff and facilities
crucial to an outstanding program.  A less visionary person would not have been as successful.

Subject: Dr. Joel Cooper - page 3
Date: Wed, 29 Sep 1999 13:54:43 +0000
From: Judith L Amerman <judya1540@juno.com>

Cooper's extensive experience with lung transplants recently has led to the early success of a new surgery for patients with severe
emphysema. The procedure, called volume reduction surgery, involves removing the most damaged portions of emphysema patient's
lungs.  Reducing the size of the lungs dramatically improves lung function and helps patients breathe.

Cooper performed the first procedure in January 1993.  Since then, more than 100 patients have undergone the surgery at Barnes
Hospital.  The overall improvement in patient's breathing capacit is 65 percent.  "For these severely disabled patients, this translated
into a marked improvement in the quality of their lives," Cooper said.

Emphysema, most often caused by cigarette smoking, afflicst an estimated 1.6 million Americans.  The irreversible disease causes
the lungs to loose their elasticity, damage their ability to expand and relax as a person breathes.  Over time, less oxygen gets into the bloodstream, and, to compensate, the lungs enlarege until they fill the ches cavity.

"Emphysema is like breathing in as far as you can and living with your chest in that position for the rest of your life," Cooper said.
"That's what happens to these patients -- their lungs are fully expanded and they can barely breathe."

Until now, the only hope for patients with end-stage emphysema was a lung transplant.  "Had it not been for observations made in
our transplant program we would not have had the confidence to thing emphysema surgery may be bene-ficial," Cooper said.

During lung transplants, Cooper found that emphysema patient's overextended rib cage and flattened diaphragm immediately
returned to a more normal configuration following surgery.  He also noticed that the severity of emphysema damage often varied
from one portion of the lung to another.

But Cooper is quick to caution that the surgery is not a cure for emphysema.  "These patients may continue to experience deterioration
from emphysema, but if we can reset the clock by two, three, four or five years, maybe more, then we think it will be very worthwhile."

Cooper and his co-workers are continuing follow-up studies on patients who have undergone the surgery.  "The bottom line is we're
enthusiastic," Cooper said.  So far, four patients have died following the surgery.  Two were over the age of 70, which has caused
Cooper to re-evaluate the criteria for surgery in this age group.

Subject: Dr. Joel Cooper - page 4
Date: Wed, 29 Sep 1999 13:54:43 +0000
From: Judith L Amerman <judya1540@juno.com>

Since Cooper first presented results of the new surgery at a meeting of the American Association for Thoracic Surgery in April,
1994, his office has fielded more than 1,000 phone calls from patients interested in learning more about the procedure.  Only patients
who have quit smoking are considered for the surgery.  (One of those calls was mine - J.)

Cooper was born and raised in Charleston, W. Va., the son of an orthodox Jewish rabbi.  As a teenager, Cooper dreamt of
becoming a neurosurgeon. He studied pre-med courses at Harvard College and graduated with honors in 1960.  He then enrolled
in Harvard Medical Schools, where he initially pursued his interest in neurosurgery.  But his enthusiasm was dampened after he saw
firsthand the grim prospects for caring for these young patients, many of whom suffered from brain tumors or other devastating
neurological conditions.

Cooper retained an interest in surgery and after graduating from Harvard Medical School in 1964, he accepted a surgery internship
at Massachusetes General Hospital.  The Harvard affiliated hospital had one of the few respiratory care units in the coutry, and it
was there that Cooper developed an interest in pulmonay physiology and respiratory care.

Under the direction of Hermes Grillo, M.D. and well-known pioneer in surgery of the airway, Cooper conducted research on
airway injuries that occur in patients on ventilators.  He traced the injury to a rigid cuff around the airway tube.  That observation
led the pair to develop a soft cuff, a version of which is used today in virtually all endotracheal and tracheostomy tubes.

"He was among the best," said Grillo, "He was a very bright guy.  I saw him as a coming star."

In order to get the proper training in throacic surgery, Cooper trained in Boston and London before steeling in Toronto in 1972.
After building a successful lung transplant program at the University of Toronto, Cooper said he was ready to move on.  He and his
wife, Janet, wanted their four sons to be educated in the United States, and the Canadian government's cutbacks in medical research
funding were beginning to hurt the university's research program.  "And, too, I think I was beginning to coast a little bit and I'm not a
coaster, I like a challenge," he said.

"As it turns out, I was able to have my cake and eat it too," Cooper said.  "I've found an extremely supportive environment here.
And we have a stronger program here than I ever could have had in Toronto."

Cooper's love for his work appears to have had a least some influence on his oldest son, Josh, who is a fourth-year medical student
at Washington University.  The younger Cooper, who is trying to decide between a career in internal medicine or surgery, said his
father has taught him a lot about caring for patients.  "Your involvement and care for patients never ends," said Josh Cooper.  You
don't punch out at the end of the day and leave the care of your patients with someone else.  My dad is notorious for being on the
phone when he's away from the hospital.  I think his patients understand how much he cares for them."

Subject:  Dr. Joel Cooper - page 5
Date: Wed, 29 Sep 1999 13:59:45 +0000
From: Judith L Amerman <judya1540@juno.com>

Cooper generously credits his wife for playing a leading role in raising their children and providing stability in their household while he
spent long hours at the hospital.  Even today, he rarely arrives home from work before 9 p.m., which is a problem for someone who
also is an avid gardener.

He and Janet have installed floodlights in their backyard, which enable them to enjoy their hobby even at night.  "We sometimes
plant flowers at two o'clock in the morning.  The neighbors think we're a little crazy."

This was published oh, probably at least 3 years ago.  Now he is working on a tube that can be inserted into the emphysema
patient's lung to help in getting rid of the CO2.  It was first tried as an external device on the outside of the chest and now he is trying
it on the inside as an implant.

On another note I just had my 2-year check up and everything is great!!!!

Personal
LVRS  E-MAILS

BUD ELLIS

http://www.geocities.com/Heartland/Ranch/6100/


.
After 2 1/2 years of going through the Medicare Part B appeals process, I received the documentation of payment for the approved surgical fee for LVRS. This case was heard by an Administrative Law Judge with
a ruling in my favor. His ruling was appealed to the Departmental Appeals Board in Washington, in turn, the Administrative Law Judge ruling was upheld by the DAB.  To my knowledge, this was the first test case for coverage of LVRS, since coverage was stopped in December 1996. Medicare Part A coverage is in the process of hospital coverage. There was a Medicare Part A denial appeals case that was heard locally by another Administrative Law Judge, which also ruled in the patients favor. This patients secondary insurance paid the surgeon fee, but refused the hospital coverage, so this is the reason for the Part A hearing only. In
the Administrative Law Judge hearing, a subpoena is issued by the judge for a specialist to testify on the efficacy of LVRS. We are making an educated guess that this patients case will be appealed to the DAB in Washington. If this case is upheld by the DAB, the possibility arises that the NETT Study will be questioned. It is our belief, that if all LVRS self pay patients will appeal their denials to an Administrative Law Judge and get a favorable ruling the NETT Study will cease to exist.  All that is required to accomplish this goal is not to accept the Medicare denials, and go through the appeals process to the fullest extent. The long process becomes stressful, frustrating, and requires patience, but do not give up until a final ruling is made.  Several people on this Forum know what has been entailed to get this far on my appeals. If you decide to self pay 
and go through the appeals process, get good documentation on LVRS. Get favorable letters from the surgeon and pulmonary physician as to why the surgery was necessary and why you were a good candidate. 
I will conclude, by saying thanks to all for their support during this process and wanted to share the good news. There is always light at the end of the tunnel.  God Bless All 
.

Subject:  Re: [COPD] pulmonary studies.....medical ethics
Date: Wed, 1 Mar 2000 12:19:43 EST
From:  Bill Horden <SOBnSA@AOL.COM>

I'm content to leave the subject of "ethics" to those wiser than I, but the NETT approach does seem to fly in the face of common sense when it offers a 50-50 chance to those who qualify, then expects the folk who are "randomized out" to passively accept their fate. The patients who can afford it are going to get LVRS at their own expense, those who can't will stay with the program for a while, participate
in their second round of pulmonary  rehab (maybe), then get back to their former lives.

This means that the "randomized" group will contain far fewer than the required 50% and will have received significantly different
treatment than planned, or will have changed addresses and be unavailable for inclusion in the "outcome" report.

NETT is the only time the federal government has attempted to regulate the development and refinement of a new medical/surgical
procedure: it was foolish in its origin and design, poorly executed, inordinately expensive to conduct, and of virtually no "value"
when completed (because so few of the randomized control group can be assessed). The PhDs and civil servants in NIH and HCFA
will label it "inconclusive" and we'll be right back where we started.

The only one who will emerge from the NETT experience with any professional growth will be the good Dr. Cooper, who flatly
refused to participate in such a limited, ill-advised "study."

Bill Horden

Subject: Re: [COPD] Nett Study
Date: Wed, 1 Mar 2000 10:53:00 EST
From: Esther Ziegler <EZ1261@AOL.COM>

I would think that there are enough people out there that have been doing rehab and state of the art medications to let doctors
know whether they have improved enough to get off of O2. I myself went through 2 years of rehab and was doing 3.5 mph on the
treadmill for 1 hour each day. It didn't do one darn thing to improve my Fev1 or my need for O2. After I had LVRS my Fev1
improved from 29% to 90%. I was able to get off some meds including O2. It has been 4 yrs since surgery and I still feel better
that I did and I haven't lost any ground and most important, I haven't been sick. The one thing that NETT doesn't explain is that
the one surgeon that opted out of the study and was primarily responsible for bringing this surgery back, never advocated that this
surgery was for EVERYONE. The NETT study knows this and by including people they already know are not good candidates,
they skew the study to show exactly what they want it to. MEDICARE DOES NOT WANT TO PAY FOR THIS SURGERY.
With 13 million patients and 10% eligible for surgery is not something they want to deal with. In the end it's money
that does the talking. Those that have it will live better and those that don't won't.

Esther Ziegler

Subject: [COPD] Status: Lung Surgery Study (NETT)
Date: Tue, 29 Feb 2000 12:31:41 EST
From: Frank Barrett <FBarrettao@AOL.COM>

I've just returned from my 12 month review in the NETT and, while there, I picked up some information on the status of this lung
volume reduction surgery (LVRS) study.  The current target of the study is to randomize 2500 patients to either the surgical or the
medical arms by July 2002. From October 1997 through mid-February 2000 they have randomized a total of 663 patients - an
average of about 24 per month.  To meet the goal of 2500 by July 2002, they will have to randomize about 63 per month from
here on.

They believe that their inability to recruit patients to the study is at least partly the result of insufficient awareness of the study on the
part of prospective patients and their physicians.  Therefore, they will mount a large national TV ad campaign beginning March 6.
It will be interesting to me to see which areas of the country actually see these ads.

Other bits possibly of interest to some -
1.  The study will not be extended beyond the July 2002 date even if they have not met the 2500 patient target.
2.  Only about 1/3 of those who begin the screening tests actually qualify to continue in the study through the randomization phase.
      (663 randomized plus 79 currently in rehab out of 2219 who started screening).
3.  Anyone interested in applying for the study can get complete information at

http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm

Frank NV

Joyce Crist" wrote:

My husband went to the NETT in San Diego in june of 98.....he had one week of tests  (hard ones) and interviews etc.   we felt
the Dr. he had was negative and not very supportive but she stated these are the facts.....all other people involved where very
good.   The pulmonary therapist was VERY GOOD....the end of the two weeks the interview was with a different Dr. as the first
one went on a little trip to celebrate her pregnancy... my husband did not qualify for the Nett  not even the excersize part, ( we
came home to AZ and he went to the excersize class here.)  they said his lungs had the damage generally all over and not in just
the lower part of the lung...  we have very good records and sent x-rays and all info before he was accepted so they knew about
the extent of the lung damage before we got there......that is of course if they looked the info.....they were concerned about a spot
on the Xray which was from and infection a year earlier.....and that really did end it all..   one gentleman we met did qualify and had
the surgery later that  year....he only had one working lung and the other was not working at all. ......very nice person....we did
write to him as he did not have any support to speak of ... but sadly he did not survive the recovery.  My husband passed all the
tests.....but the spot took him out....

At 06:03 PM 2/29/00 , Kenneth Jolly wrote:
Of course this will throw the desired results out of kilter, because they do not have the medicated group and the poor souls who
are given placebos to compare the final results. This of course does not alter the numbers you quoted or the ones who were
helped and those who had poor results.  Just a question on the process, I think it is unfortunate for those who want the surgery
and by the roll of the device may be taking placebos....
Ken Jolly of KY

From: Debby Thompson <CADebby@earthlink.net>
Date: 2/29/2000 11:33:03 PM
Subject: Re: [COPD] Nett Study

I do believe that there never was a placebo group just the ones randomized to what I call the surgery group or the rehab group.  It
is felt by some doctors that the same results may come more from the rehab than from surgery -- while some still believe that
neither will help.  I was under the assumption that the main purpose of the "study" is to justify (or not) the cost for medicare to pay
for the surgery.  If the benefits can be obtained by rehab why should Medicare pay for the surgery??? Is the benefit obtained by
surgery quantifiable enough to justify Medicare footing the surgery bill. There are insurance companies that are still pay for the surgery
or at least mine still does.

Just my two cents.  Debby in Ca.

Date: Tue, 28 Sep 1999 13:57:03 -0700 (PDT)
From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

CPPC NEWS & ACTION ALERT

The CPPC's efforts are taking hold -- continue to fight!  Do not give up!  As a result of our efforts and those of others, a bipartisan
cadre of influential senior Senators and Representatives is calling for a face-to-face meeting with Medicare officials to resolve the LVRS problem.  Lead by Senator Edward Kennedy (D-MA), this group of Representatives include Senators Bill Frist (R-TN), Arlen Specter (R-PA), and Ted Stevens (R-AK), as well as Representatives John Lewis (D-GA) and John Porter (R-IL).

Please visit, call, or write your Senators and Representatives and press them to join this group and demand Medicare modify its LVRS policy.  And specifically, ask your Senators and Representatives to contact Senator Specter, the Chairman of the Appropriations Subcommittee on Health, and ask that he hold a hearing as soon as possible on Medicare's LVRS policy.

January 1, 2000 will mark four years since Medicare stopped paying for LVRS.  During this time, too many of us continue to watch as
our loved ones suffer and die with emphysema.  So keep up the good fight!

If you need help identifying your Senators or Representative, then please contact the CPPC.  We'd be happy to assist.  And, as
always, if you write, please copy the CPPC on your letters and responses you receive.  If you visit or call, please let us know
about the response you receive.

Please invite all your friends and family to join CPPC and help in this fight. We need every person to help.

Our web address is: HTTP://members.xoom.com/CPPC_USA

We can win this if we all work hard and enlist help from everyone we know.

Subject: HCFA APPEALS
Date: Mon, 20 Sep 1999 16:49:24 -0700 (PDT)
From: coalition Pulmonary <pulmonarycoalition@yahoo.com>

Dear Members:
Several of you have had LVRS as a self pay patient due to being randomized to medical or giving up on HCFA and proceeding
with the surgery. There are some who have filed appeals for the non payment of benefits. One of our members got a letter from
Dr. Grant Bagley, Director, Coverage and Analysis Group for HCFA.  The person enclosed the following information from Dr.
Bagley's letter.

"I understand the frustration you are facing with your husbands illness, and your concerns about the possibility of securing financial
reimbursement. Any person may file an appeal to their Administrative Law Judge, but National Coverage decisions are binding.
This means, although the ALJ may make recommendations that the coverage decision be reviewed, it cannot overturn and order
payment for the items and services which were found "not reasonable and necessary" due to a lack of evidence of medical
effectiveness. It was Congress who vested this Statutory authority to the Secretary in Section 1862a(1)A of the Social Security Act."

We knew that HCFA could make a decision at any time concerning any procedure, to not cover the benefit or procedure. HCFA
exercised that power, when making LVRS a non covered benefit.  We thought there was an appeal process in place for them
exercise their right to a fair appeal.  Now according to Dr. Bagley, the patient does not have appeal rights. Technically, they can
appeal but HCFA has a rule in place that will not let the patient win.  So in essence there is no appeal process.  This is outrageous.

The decision, now being discussed is for LVRS but if they can make this kind of decision concerning this procedure, they can make
the same decision concering any treatment or procedure.  HCFA has no limits or bounds as for what they can or can not do.

I am appalled that Congress has given HCFA total and 100% control of peoples lives and their health care.  People are forced by
law to pay into HCFA and when they become eligible for Medicare, it becomes their primary health care insurance.  These  are
situations that people have no control over.

You should ask your elected representatives how in good conscience they can let HCFA get away with walking all over people and
their right to health care.  Taking away the appeals process for a patient, who follows their physicians advice and receives health
care as prescribed by their physicians as a self pay patient.  These patients, according to Dr. Bagley, have no rights.  Not to health
care, not to a fair appeals hearing.  Remember people have no choice they are mandated by law to pay into HCFA. Now we learn
that they also have no appeal rights  for non covered procedures.

Congress has the power to change this. One way this can be accomplished by law.  The other way to change the present situtation
is to withhold funds until such time as HCFA starts to address these problems.

Members, you should get every person you know to write thier Senators and Representatives and demand this be addressed.
Patients deserve the right to a fair appeal process.  Remember now it is LVRS but what will be next.  Do you know for sure?  Do
you want to gamble with your health care?  Do you want the right to an appeal process that will no let HCFA dictate the outcome?
I urge you to get as many people as possible to address this issue.

Thank You, CPPC

Subject: [COPD] ONE PERSON'S EXPERIENCE WITH LVRS SURGERY-SURGICAL  CHRONOLOGY #1
   Date: Wed, 18 Aug 1999 13:16:38 -0500
   From:
        GBrown <gbrown@MAIL.WIN.ORG>

 I HOPE THIS DOESN'T BORE EVERYONE, BUT I THOUGHT IT MAY BE OF VALUE TO THOSE FOLKS WHO
ARE THINKING ABOUT LVRS AND HAVE A LITTLE FEAR OF THE PROCEDURE.  AS YOU READ IT, PLEASE REMEMBER THAT LVRS ISN'T FOR EVERYONE, BUT IN MY CASE IT IS A GODSEND AND I AM SO THANKFUL
AND GRATEFUL.

This is the missal that I promised to write on the history of my LVRS in late May of this year. I will try to relate as much about my
surgery as I can, and fortunately my diary that I kept at the hospital has provided many insights to my thoughts as they happened.
 Today I am sitting in the pulmonary testing clinic at St. Louis University waiting on a good friend of mine from church who is being
evaluated for LVRS.  He is 64 years of age, and on oxygen 24 hours a day.  I pray he can qualify for the NETT and is selected for
the surgery.I was diagnosed with emphysema in 1987 and started rehab at our local hospital in 1991.  I began using oxygen only for exercise only at that time.  By October 1995 I was told to use oxygen all the time, but vanity prevented me using it when I went out.  Eventually, I began using it even going restaurants, the oxygen being provided by an Oxylite system. In March 1997 I was feeling so
bad and fatigued that my pulmonary Dr. prescribed anti-depressant medication.  Examination from the Dr's could not find a reason
for the fatigue so the conclusion for feeling fatigued was blamed on emphysema.  The depression was obviously my mental state
resulting from being prevented to do much or restrained from doing the things I love to do.  I was always a very active individual,
and had a terrible time adjusting to this big change in my life style. It was about this time that I began considering lung transplant,
but I have known three people who underwent that procedure, and all had problems, and are now deceased!  In addition, the
risk of taking the anti-rejection drugs is great - the drugs attack other vital organs, so I ruled out the avenue of option.  My inquiry
into LRVS seemed to be the best option, but Medicare had stopped supporting the procedure - deeming it too experimental, and my secondary insurance carrier would not pay for anything that Medicare refused.  I then heard about a new program that Medicare was
going to support called NETT, and to which 17 hospitals in the country were to participate in.  Two of the hospitals were in St. Louis.
 Dr. Cooper, at Barnes Hospital was one of the leaders, but later dropped out because Medicare would not let participating
practitioners perform she procedure outside of the NETT program.  This would preclude him from serving patients who could pay on
their own or had insurance coverage for the procedure.  Cooper would have been my personal choice to have the surgery as he was
one of the pioneers
in the development of the procedure, and is a recognized leader in the research.  Dr. Naunheim was the surgeon at St. Louis University Hospital (SLUH) who participates in the NETT program, and who performed my surgery.  I was interviewed by him on 6 May 1998.
 He fully explained the procedure, the risks and how the NETT program functioned.  After an initial evaluation at SLUH, I would have
to undergo 6 weeks of exercise at SLUH (5 days a week) or at a satellite facility (each 30 Miles from home).  I decided to wait until an additional satellite facility opened up nearer to home. This may be the proper time in this discourse to explain that there are two surgical procedures employed for LVRS.  The predominant procedure is open Sternum surgery.  The chest is opened at the breastbone just as open-heart surgery is performed.  Access to the lungs is achieved in this manner.  The second procedure is known as VATS (the
acronym for Video Assisted Thoracic Surgery).  In this procedure, three incisions are performed on each side of the chest, and
instruments are inserted through the incisions to perform the surgery.  One incision is for insertion of a video head camera (very small),
a second incision is used to insert scissors to cut the desired lung tissue, and the third incision is for a small stapling machine.  Animal
bladder is positioned over the severed lung tissue and stapled to the lung to affect the seal.  On 28 January 1999 SLUH hospital called
and informed me that a satellite facility was approved in St. Charles (the same facility that I have been going to for rehab since 1991.  I made an appointment with Dr. Naunheim's office and requested to be entered into the NETT Program.  I met with Dr. Keller who is the pulmonologist in Naunheim's office.  Again the program was explained to me along with the associated risks, and I felt better prepared
for the ordeal (perhaps mental desperation made it more acceptable). My laboratory tests were scheduled for March 2, 3, and 9, and
these were not at all bad.  On March 18 I was notified that I met the criteria for inclusion in the NETT Program, and on 22 March
started the exercise strengthening rehab program for one week at SLUH and then underwent the remaining 5 weeks of rehab at our
local hospital.  May 8 was the final day of the six-week rehab program. At the conclusion of the exercise program, my name was
entered into the NETT randomization database for selection of either the surgical arm or maintenance arm (a computer does the
selection - 50% to either arm).  May19 I was notified that I had been selected for surgical LVRS procedure.  I was one happy girl,
very relieved from the aphrehension and at this point very anticipatory to receive the surgery!  Two surgical dates were offered me, May
26 or 1 June, and I elected May 26 (figuring early was better than worrying for a full week).

Subject:  [COPD] ONE PERSON'S EXPERIENCE WITH LVRS SURGERY-SURGICAL CHRONOLOGY#2
   Date:  Wed, 18 Aug 1999 13:19:23 -0500
   From:  GBrown <gbrown@MAIL.WIN.ORG>

It may be appropriate to mention here that the NETT Program monitors all applicants entered into the NETT for 5 years.  That is the
period of  time that NETT requires to determine whether LVRS is a viable and successful procedure to reinstate Medicare approval of
the procedure - thereby opening up the procedure to all disability persons.  I had indeed put all things into the hands of the Lord, and as
his word says - All things work together for good for those who love the Lord.  I felt so peaceful about everything as his word says it surpasses all understanding.  I was prepared to die if that is what God chose.  I felt I might be avoiding a terrible death in the near future.
My surgery is described as bilateral (both lungs) lung reduction by the VATS method. It took a full four hours for the surgical procedure
to be completed, from which I awoke with a sensation of happiness - happy for the gift of being alive and happy I wasn't on a ventilator
for life support.  I was transported to ICU and spent the night there.  The next day, 27 May, I was placed in a regular patient room on
the ICU floor and remained there until discharge from the hospital.   I didn't experience much pain this day but I did note in my journal
that the evening of the surgery I had complained of pain in the left lung.  The SLUH practice is to install an epidural implant in the lower
spine that administers a constant medication level, and is a very effective pain relief drug. May 28 - I become aware of the appliances attached to me - two tubes, one from each lung to allow air to escape until the lungs seal.  This is the most difficult of all recuperation - getting the lungs to seal.  The norm is seven days - mine takes nine days, and if there is a persistent leak then surgical restapling is the corrective procedure.  In the afternoon it was determined that my right lung had sealed, so that tube was removed.
Good news!
May 29 - I had a bad night, my oxygen level was down to 80. They had given me breathing treatments with a machine and applied
quite strong clapping on my back for a long period of time.  I didn't panic, and did pursed lip breathing in an attempt to remain calm.
May 30 - I awoke feeling great today.  A lot of company came in today to cheer me up.  Maybe too much as it tired me quite badly!
But there is no doubt that I am breathing easier, and the walks are longer, and easier as I gain strength.  I am connected to oxygen on
these walks still.
June 1 - I had a wonderful night rest, no problems breathing whatsoever. I had at least two short walks, and am still connected to oxygen.
June 2 - Surgery was a week ago.  Today I feel great and am breathing well. My left lung still hasn't sealed, but the leak is very small and
the Dr's expect it to seal in a short while. Dr. Naunheim says it is going to take time and that I am doing great, and not to fret over the leak.
June 3 - I continue to feel good.  I took two long walks today, but still have some pain in my left lung.  I'll be glad when they remove the
tube (and it will be taken out when the lung seals.
June 4 - I feel wonderful!  My spirits are up and I felt strong enough to take many walks today.  I have been told that I will go home
tomorrow.  I will have to return to the hospital after the lung lung has sealed to have the tube removed.
June 5 - going home, that sounded wonderful.  There is nothing like the sound of that word when so many days have passed where all I
see is the sterility of white rooms and medical people.  I am still on oxygen but that is not a great disappointment. I have been lectured on
all the conditions I can expect when I am at home.  A visiting nurse will come to the house and clean the incisions and change dressings.  Home looks beautiful!

Subject:  [COPD] ONE PERSON'S EXPERIENCE WITH LVRS SURGURY-SUGICAL CHRONOLOGY#3
   Date:  Wed, 18 Aug 1999 13:21:21 -0500
   From:  GBrown <gbrown@MAIL.WIN.ORG>

June 7 - I returned to the hospital for a check-up on the leak - Thank God it had sealed so the last tube was removed.  My home care
nurse continues to come every other day for another week, and did so until the stitches were removed at the hospital.I feel wonderful.
My energy level is something else!  I sometimes awake in the middle of the night and feel so good that I will begin to do things that I
have been unable to do for so many years.  It's like I want to make up for lost time. And I can do almost everything except lifting objects.

The foregoing is about all the relevant events prior and subsequent to the surgery.  It has all been uphill since I got home.  My energy
and stamina continue to improve, and I do not even require oxygen at my rehab - treadmilling at 3MPH for 30 minutes at zero incline
(as long as I do not try to talk), doing arm exercises, etc.  My doctors told me that I would experience improved pulmonary functions
for a month after the surgery, and that would be my peak.  I believe that I am still improving.  The recent heat and high humidity weather
we have had did not bother me very much.  I was going out in it and conducting the usual business of running a household.  I have not required home oxygen since June 3rd. I feel very close to God.  He is awesome!  He kept me here for a reason and I want to bring
glory to his name by helping my fellow man, worshipping him and reading his word. I will keep you in my prayers.  E-Mail or call if I
can be of any help in anyway.  Please let me know how things go.
Your Christian Friend,
Wanda Brown
June 6 - This is a great day.  I felt like I wanted to go to church, so I went.  My medication include a pain pill taken when I need them.
 I find I do not need oxygen, though I don't try to go real long periods without, and I do sleep with the oxygen.  What a blessing to be
free of the oxygen when I decide to go without.  The visiting nurse came and changed the dressings and cleansed the incisions.  The
incisions are not healing very fast due to the fact that I am diabetic.  The nurse informs me she will visit me every other day for attending
the incisions.

Subject:  Re: [COPD] LVRS & NETT
   Date:  Wed, 14 Jul 1999 17:48:18 EDT
   From:  Amy Killian <Monetme@AOL.COM>
 

I have been a lurker for quite sometime now, but have finally decided to get a little more active on here.  I work for a facility who
was chosen to participate in the NETT, but our facility decided the NETT was not for us and so ....we dropped out to help the
patients who were randomized to the medical arm, patients who did not want to be randomized, patients who do not have Medicare,
but private insurance and cannot be part of the NETT, patients who want to self pay or patients who have a secondary and not a supplemental to Medicare.  I am not a nurse, but have access to clinical information, and also I do all the battles with insurance
companies to obtain coverage for our patients.  Our thoracic surgeon is Joel Cooper, M.D., and he is considered to be the pioneer
of lung volume reduction surgery.  If you would like to call our office to receive a packet of information, or would like to talk
to one of us, please do so.  We have a toll free number and anyone who would like to receive this information, please call our office.
Our toll free number i1-800-851-9479.  My name is Claudia Stephens, just ask for me and I will try to assist you in your search.
Thank you Claudia

Subject: [COPD] LVRS
   Date: Fri, 2 Jul 1999 22:24:24 -0500
   From:  GBrown <gbrown@MAIL.WIN.ORG>

Hi Folks, I'm so sorry to be so slow in informing you folks on the list how I am doing!  My surgery was the bilateral lung reduction
and was done on May 26 at St. Louis University hospital by Dr. Naunheim. I awoke from the surgery (3 plus hours) and was amazed
that I was not on a ventilator!  I was breathing without assistance, but was on oxygen @ 2L (the same as when I was admitted).  From
that point, I began to improve while being administered with exceptional pain control management (epidural).  I did have a slow leak
from the left lung which was predicted to seal within two weeks. I was on my feet and walking the day after surgery, pulling my
beloved oxy bottle as I struggled to make a 200 foot walk.  In addition to the oxygen bottle, my other apparatus to manage during the
walk were chest drain and epidural bag.  By the date of my release (after seven days hospitalization), I was taking the 200 foot walk
without oxygen!  A feat that hadn't been accomplished in years.  I still had the leaking left lung when I was released, but had the Dr's assurance that it would seal in very short order.  The medical personnel were quite pleased with the immediate results of the surgery
and sent me on my way.  A visiting home assistance nurse was assigned to visit me every two days to clean and dress the incisions
and advise me on what I could and couldn't do during recovery.  Pain management was still excellent and tolerable except when I
forgot to take medication (percocet).  The lung sealed itself three days after hospitalization.  The sealing was confirmed at the hospital,
and x-rays were also taken. I removed myself totally from oxygen by the 14th day after surgery (I had been using oxy at night
previously but had tapered off daytime use).  I was feeling great and knowing that my breathing was better than in the previous ten
years.  My energy level was amazing, and I didn't want to stop  doing things I hadn't done in years.  When I did get tired, a very
short nap rejuvinated me and I continued to do these wonderful things that had been denied me during the past years.  How
wonderful it was to venture out and enjoy those simple pleasures -WITHOUT ANY OXYGEN!  It has now been five weeks since
surgery, and I continue to improve.  I have no restrictions on activities, and am frequently in shopping centers for 3-4 hours, and out
of the house for up to eight hours, but I infrequently do require a puff from my inhalers.  I started back to rehab three weeks ago, and
now can manage 2.5 MPH for 30 minutes on the treadmill without oxygen (prior to surgery the same regimen required 4LPM of
oxygen).  The medical people predict I will continue to improve for six months, reaching a plateau and then the degenerative
characteristics of emphysema will slowly degrade my functions.  The doctors are anticipating that the LVRS will give me a good four
or five years of improved function before degrading to my presurgery levels.  I intend to prove that the procedure is much more
effective than that!  But I do recognize that someday a transplant may be in my future. In closing this missal, I can recommend LVRS
to anybody - it has certainly provided me with what I consider a NEW LIFE. Please feel free to contact me through private e-mail at:

        Sincerely, and good breathing to all,
                Wanda Brown

Subject: NETT NEWS
   Date:  Fri, 25 Jun 1999 12:46:27 -0700 (PDT)
   From: coalition Pulmonary <pulmonarycoalition@yahoo.com>
     To: Pulmonarycoalition@yahoo.com

I must share with you some disturbing news that requires our immediate action -- which means every one of us.  HCFA believes that
low recruitment of patients in the NETT is the result of not many emphysema sufferers really wanting the surgery.  HCFA does not understand that patients who have been on pulmonary rehab cannot afford to take the financial risk or have the energy to relocate themselves and their loved ones to go through six weeks of more rehab to then be subjected to a coin flip that puts them in rehab for
at least four more years!  HCFA believes it must protect us, Medicare beneficiaries, from our own physicians.  Here are the most
recent stories and statistics we have gathered from 2 CPPC members and the American Thoracic Society.  HCFA is trying to twist the
lack of patient enrollment as reflected by these statistics in its favor to defend its decision not to cover the surgery.  What an outrage!

In one of the reports the surgeon told the NETT patient that the number of patients to be included in the NETT is reduced from 5700
to 2500.  Why??  They cannot attract enough people to participate in the study. It is reported they plan to spend $2 million in media advertising in hopes of attracting more applicants for the NETT.  Is this not a total waste of money?  Should not both HCFA and NHLBI
be made accountable for this lapse in good judgment? Does this not prove that NHLBI and HCFA are trying to recruit patients, because
the study is so poorly planned it does not attract patients on its own merits?  It proves that patients are not willing to make the sacrifices
that the NETT study demands.  Relocation and travel expenses are prohibitive for many.

According to this doctor about 400 patients had been randomized in the NETT. This patient also reported that the NETT study was expected to conclude in four and a half years form the time the first patients were randomized in February 1998.  This would put the
target date for closing the study in August 2002.

These statistics were confirmed through another NETT surgeon who reports that 395 people have been randomized, 197 to surgery
and 198 to medical.  This person makes an excellent point: at this rate it will take at least 9 years for them to get the 2500 patients randomized.  And how long does Medicare intends to track the results after randomization is completed will further delay Medicare
paying for LVRS. This is not acceptable.  The fact that the NETT study will end in 2002, does not mean that HCFA will immediately
start paying for LVRS.  They will have the option of continuing to follow patients that were in the study.  This means we could have
another period of time that they will not be paying for anyone to have LVRS. Only patients enrolled in the NETT would get treatment.
 We basically would be just where were at in January 1996, when HCFA made the decision to not fund LVRS.

Mix into this the fact that the NETT is still tracking the results of people who were randomized to medical but dropped out of the NETT
to have the surgery outside the NETT as self pay patients.  They will still be followed as if they were still in the NETT's medical category. NETT is supposed to attach a form, which says the patient had treatment, but not as intended.  This mixing of data can not possibly
produce a scientific result.

The third piece of information comes from an article on the American Thoracic Society web page. NETT had screened 1200 patients
and accepted more than 30% into the study for randomization.  30% would be 360 patients, so about 33% were randomized into the
study, if we accept the "almost 400" the two NETT doctors spoke of.  But according to the article more than 150 had been randomized
to surgery.  This would mean that about 250 were randomized to medical. While it is close, this does not match the information the
patients received from the two NETT doctors.

In this day and age of computers, it should not be difficult to get exact numbers.  Each center is supposed to be funneling all information
into Johns Hopkins.  If the centers are complying and reporting and Johns Hopkins is posting the data, then exact information should be available at a moment's notice.  At the beginning of each day, they should be able to say with certainty what the numbers are at the start
of each day.

Now what do you need to do?

Write your Senators and your Congressman to let them know you want Medicare to pay for LVRS and that you want better access to
the surgery.  If you do not speak up, then Congress will believe HCFA when they are told there really aren't many patients who want
this surgery.  Congress needs to hear from all of us that randomization is not acceptable!  Randomization is the reason for low patient enrollment. Not because we do not exist!  We do not want to be the government's guinea pigs!  We've all paid into the system and we should be able to make informed decisions with the advice of our doctors.   So speak up and press your representatives to answer the following questions: When does HCFA and NHLBI plan to end the study?  And will HCFA modify the NETT study to let more
qualified candidates get the surgery without randomization?  If not, why not?

If you have specific questions that pertain to you personally, then of course ask them too.

Now the important part.  Demand an answer.  It seems our elected officials like to just file information, and say " yes I know about
that", without answering their constituents' letters.  Make them aware you are a voter.  Make them aware they are in Washington to represent you.  After posing your questions, tell them you expect to hear from them in the near future.  Make it clear you expect a
response.  Make it clear you are keeping a record of letters and questions that do or do not get answered.  Make it clear, that your
letter not only represents you and your views, but other voters in your household, or circle of friends.  Tell your elected officials that
you belong to groups like CPPC, as well as other clubs and organizations.  Tell them you hope to be able to report positive results in
your dealings with them.  Keep the tone of your letter professional but make it clear you want an answer.

Thank You, CPPC

Subject: [COPD] LVRS
   Date:  Thu, 17 Jun 1999 10:48:16 EDT
   From:  Esther Ziegler <>
     To: Esther Ziegler <EZ1261@AOL.COM>

Jack and others who are considering LVRS.

There is a lot of information on the Internet about LVRS and if it was me (and it was and I did) I would make sure that I read all of
both pro and con about this procedure. IT IS NOT FOR EVERYONE! If you have diffuse emphysema (spread all through the lungs)
the surgery is not for you. The history has shown that this group of people does not do well. The NETT trials do not exclude these
people so know if you are unfortunately one of these people.  People who are older than 70, also do not fare as well as the younger
(under 70) population. NETT trials do not exclude these people either. There were enough studies done before the NETT trials that
showed this to be true.  Please don't forget the politics that has always been the reason for this study from the beginning. HFCA
doesn't envision paying for the 10% of 13 million people who would benefit from this surgery. My personal opinion is that cards are
stacked against the procedure becoming a paid Medicare surgery and the people who submit to the NETT trials are the guinea pigs
. Just make sure you know which type of emphysema you have before getting into the trials. Now if you are a good candidate as I
was it can be a new life. My fev1 went from 29% to 90% and at my last doctor's visit, my PFT's showed no loss after three years.
I have not been sick since I had the surgery. I was 60 at the time of surgery and my hyperinflation was located in the top of both
lungs with the bottom looking more normal. This is the ideal place and you must remember that it is not a cure!

Hope this information helps.

Esther Ziegler

Thanks  to all for your response and good wishes.  I'll set forth Ed's background which may answer most questions. His COPD was diagnosed in June 97 at Northwestern Hspt. in Chicago.  Oxygen saturation was 41%.. He was a carbon dioxide retainer and his extremeties were actually blue tinged.  Couldn't walk more that 15 ft. without resting.  He was released from NW on 3 liters of oxygen
24 hrs. a day.  He entered a 8 week rehab program at NW  and after completion they referred us to the U of IL. which we believe
was the only hospital doing LVRS in the Chicago area at that time.  U of I did not feel that surgery on left lung would be of any benefit,
and after completion of testing he had laser surgery on his right lung (approximately 30% removed.) He did not qualify for NETT
because he is not 65 yet.  Our insurance Qchip (Quality Ins. of IL) has covered everything including physical therapy Phases 1 & 11.
 We have a small copayment on oxygen as we have both a concentrator and liquid oxygen.  He is in Phase 111 therapy, which is not covered, but the cost is minimal.  He was in the hospital for 16 days.  8 days in Cardiac/Thoracic ICU and another 8 days in the Step-
down unit.  He was on the treadmill, twice a day, the day after surgery and every day he was in the hospital.  Complications arising
from surgery in the hospt. were pneumonia (which was clered up quickly)  air leakage, and after he was released he developed fluid
on his lungs which fortunately cleared up with lasix.  In June his FEV1 was 15 which was a teensy improvement.  He is scheduled for
more testing at the end of the month.  He is on the treadmill and exercises everday.  He is still on oxygen, has some really good days
and some really bad ones.  Oxygen ranges from 2 -4 liters depending, and he is still on the same meds.  He is not on any steriods
(except for Flovent)  All of the doctor's have advised us LVRS is not to be looked at as going to Lourdes for a miracle cure.  Some
people are able to leave the hospital after a week without  supplemental oxygen.  For others it takes much longer.  What they do in the surgery is to further damage a damaged lung.  It takes time in these cases for the lung  to heal and then to start functioning again.  We
want to believe them and hope they are not just handing us a sugar pill, which is why we wanted to talk to other people who have had
the surgery or are contemplating it.  Quality of life has not improved much for him at this point.  Sporadically he will have easy breathing
of 1 or 2 days duration.  The last time this happened he enjoyed 10 days of  almost normal breathing.  Then he got a flu shot and it
knocked him out again..  The one thing that has improved is not worrying about whether he would qualify for the surgery.  That part
is over.  Now his concentration centers on improving physical capabilites.  Would he recommend the surgery?  Yes, by all means.
While it is difficult, it is the only option for many of us, and now he knows that at this point he has explored every avenue.  Perhaps
up something else.
Joan & Ed in Chicago

Subject: Re>LVRS
        Date: Wed, 20 May 1998 17:55:55 -0500
       From: personal <ccmills@pop.nstar.net>
 Organization: personal To: o2@olivija.com
Olivija, I am due to have lvr surgery 6/9/98 at Barnes Jewish in StLouis by Dr.Joel Cooper, I have had emphysema since 1976.  I
became copd about 4 years ago. Have been on o2 4lpm.24/7 since 6-95 .  I have been hospitalised many times in the last 20 years
with infections.  The worst being 1997 I was in 12 times.  I started in rehab in Dec. 97 and finished  May 1, 98 and am currently
doing over two miles a day on my tred mill.    I do 30 minutes morning and evening I do 1 mile in 20-22 minutes and then finish the 30 minutes.  I also work out with 2 pound weights and threa bands.  We have to be in StLouis 6-31-98 then they will redo the evaluation
on me and I will go thru a week of rehab before surgery.  They are going to remove 40% off of the top of my left lung.  I am trying to get them to go ahead and do a bilateral since my heart and body is in much better shape than it was in Sept. 97 when they first evaluated me.
Olivija, This is very rough draught but I will redo all of it after the surgery for you.  I just wanted to give you a quick look at the last 2
years which is not complete but will give you a quick look. I will answer any questions you or any one might have that I can. Thanks for
all the work you guys are doing.
With love and respect
Cecil

Thanks  to all for your response and good wishes.  I'll set forth Ed's background which may answer most questions. His COPD was diagnosed in June 97 at Northwestern Hspt. in Chicago.  Oxygen saturation was 41%.. He was a carbon dioxide retainer and his extremeties were actually blue tinged.  Couldn't walk more that 15 ft. without resting.  He was released from NW on 3 liters of oxygen
24 hrs. a day.  He entered a 8 week rehab program at NW  and after completion they referred us to the U of IL. which we believe
was the only hospital doing LVRS in the Chicago area at that time.  U of I did not feel that surgery on left lung would be of any benefit,
and after completion of testing he had laser surgery on his right lung (approximately 30% removed.) He did not qualify for NETT
because he is not 65 yet.  Our insurance Qchip (Quality Ins. of IL) has covered everything including physical therapy Phases 1 & 11.
We have a small copayment on oxygen as we have both a concentrator and liquid oxygen.  He is in Phase 111 therapy, which is not covered, but the cost is minimal.  He was in the hospital for 16 days.  8 days in Cardiac/Thoracic ICU and another 8 days in the
Step-down unit.  He was on the treadmill, twice a day, the day after surgery and every day he was in the hospital.  Complications
arising from surgery in the hospt. were pneumonia (which was clered up quickly)  air leakage, and after he was released he developed
fluid on his lungs which fortunately cleared up with lasix.  In June his FEV1 was 15 which was a teensy improvement.  He is scheduled
for more testing at the end of the month.  He is on the treadmill and exercises everday.  He is still on oxygen, has some really good days
and some really bad ones.  Oxygen ranges from 2 -4 liters depending, and he is still on the same meds.  He is not on any steriods
(except for Flovent)  All of the doctor's have advised us LVRS is not to be looked at as going to Lourdes for a miracle cure.  Some
people are able to leave the hospital after a week without  supplemental oxygen.  For others it takes much longer.  What they do in the surgery is to further damage a damaged lung.  It takes time in these cases for the lung  to heal and then to start functioning again.  We
want to believe them and hope they are not just handing us a sugar pill, which is why we wanted to talk to other people who have  had
the surgery or are contemplating it.  Quality of life has not improved much for him at this point.  Sporadically he will have easy breathing
of 1 or 2 days duration.  The last time this happened he enjoyed 10 days of  almost normal breathing.  Then he got a flu shot and it
knocked him out again..  The one thing that has improved is not worrying about whether he would qualify for the surgery.  That part
is over.  Now his concentration centers on improving physical capabilites.  Would he recommend the surgery?  Yes, by all means.
While it is difficult, it is the only option for many of us, and now he knows that at this point he has explored every avenue.  Perhaps future research will turn up something else.
Joan & Ed in Chicago

Subject:  NETT STUDY
   Date:  Sat, 15 May 199907:14:15 -0700 (PDT)
   From:  coalition Pulmonary <pulmonarycoalition@yahoo.com>
     To:  pulmonarycoalition@yahoo.com
    CC:  Senator Thompson <senator_thompson@thompson.senate.gov>,
        Senator Warner <senator@warner.senate.gov>,
        Representative Watts <rep.jcwatts@mail.house.gov>,
        senator Monihan <senator@dpm.senate.gov>,
        Representative Moore <dennis.moore@house.mail.gov>,
        Senator Murray <senator_murray@murray.senate.gov>,
        Representative NC <NC12.public@mail.house.gov>,
        Senator Nickles <senator@nickles.senate.gov>,
        Senator Robb <senator@robb.senate.gov>,
        Senator Roberts <pat_roberts@roberts.senate.gov>,
        Senator Schumer <senator@schumer.senate.gov>,
        Senator Sessions <senator@sessions.senate.gov>,
        Senator Shelby <senator@shelby.senate.gov>,
        Representative Smith <adam.smith@mail.house.gov>,
        Senator Spector <senator_spector@spector.senate.gov>,

DEAR MEMBERS:  IN THE LAST FEW DAYS WE HAVE QUITE A BIT OF MAIL CONCERNING THE NETT STUDY.
THIS IS TRYING TO PUT TOGETHER THE LETTERS, SO HOPEFULLY YOU CAN SEE WHAT IS GOING ON.

I BELIEVE THAT THE LETTERS AND EXPLAINATIONS FROM DR. WEINMANN, LEAVES A LOT OF QUESTIONS.
 IF THIS IS HAPPENING AT UCSD, THERE IS NO REASON TO THINK IT MAY BE GOING ON OTHER PLACES.

WITH THE QUESTION MARK ABOUT DUKE AND ITS BEING PUT ON SUSPENSION, EVEN IF AT THE PRESENT
TIME A PORTION OF THE SUSPENSION HAS BEEN LIFTED, IT LEAVES QUESTIONS AS TO VALIDITY OF ANY NUMBERS FROM THE NETT STUDY THEY MAY REPORT.
CPPC

Subject: CPPC
   Date: Sat, 8 May 1999 08:25:55 -0700 (PDT)
   From: coalition Pulmonary <pulmonarycoalition@yahoo.com>
     To: pulmonarycoalition@yahoo.com

CPPC News in the Pulmonary Paper:
The Coalition of Pulmonary Patient Care (CPPC) reports the length of the National Emphysema Treatment Trial is being cut in half,
from the original estimation of seven years to between three to four years, The Federal Government has shortened the trial by
modifying the ultimate outcome it has decided to measure: quality of life, not mortality. The NETT will take less time because fewer
patients are needed to measure quality of life. To help reach a coverage decision about LVRS, Medicare is now reviewing nearly
100 peer review articles LVRS which up until now it has ignored.  [Note: This information could not be confirmed or denied when
The Pulmonary Paper called the Health Care Financing Administration.]
The CPPC would like to see Medicare modify its coverage of LVRS to enable patients to have access to the surgery now. They
urge you to write to First Lady Hilary Rodham Clinton (email first.lady@whitehouse.gov), HHS Secretary Donna Shalala
(hhsmail@os.dhhs.gov), and HCFA Administrator Nancy Ann DeParle (NDeparle@hcfa.gov) to tell them how the quality of
your life or the lives of your loved ones have changed as a result of receiving or being denied LVRS.
TO ORDER THE PULMONARY PAPER:
CALL 1-800-950-3698
FAX 1-904-673-7501
Or mail to: The Pulmonary Paper
PO Box 877
Ormond Beach, FL. 32175
Cost $17.95 per year

A letter written to Dr. Weinmann by one of our members:

I would like the following questions answered, Under the Information Freedom Act:

1. How many people have been screened for the NETT study?
2. How many have been accepted into the NETT study?
3. How many have had surgery and how many have been randomized to medical?
4. How many that were randomized to medical, continue to be an active part of the NETT study.
5. What category are you putting people in, who was randomized to Medical, but in fact then had surgery as a self pay patient?
6. NETT centers want the self pay surgical patients to stay in the study, but seem to want them to be a part of the medical arm
statistic.  Is this true?
7. How can you come up with accurate results, if the medical arm has a mixture of surgical patients in it?
8.  Will this not come up with convoluted numbers that would be cause for argument?  This study was supposed to answer question,
not create more
9. Also, how many have been randomized at UCSD?
10. How many were randomized into surgery and into medicine?

Please answer by E mail.

Thank you,

RESPONSE FROM DR. GAIL WEINMANN AT NHLBI

I will try to answer all your questions by answering this e-mail first.

As of April 30, 1999, 1393 subjects had entered screening at the 17 centers.  Of these, 533 have been found so far as eligible to
enter the rehabilitation phase of the study.  Most of these will eventually be randomized, though a few will not.  As of April 30,
360 subjects had been randomized.  UCSD has randomized 13.  The randomization is one to one, so on average half are
randomized to medicine and half to surgery.

So far, very few subjects in either the medical or surgical treatment groups have dropped out.  A few subjects (data after
randomization are confidential, so I do not have exact numbers, but the numbers are small, less than 5) in both treatment groups
have decided to cross over to the other treatment;  that is, some assigned to medicine have had surgery and some assigned to
surgery have decided not to proceed.  I think the numbers are about equal, based on the information I hear from the clinics.

Strictly speaking, all patients who are randomized are followed on an "intent to treat" basis.  This means subjects are followed
according to their treatment assignments.  If you are randomized to medicine, you are followed as a medical patient even if you
have surgery and vice versa.  I have heard of one NETT subject assigned to medicine who died post operatively after having
self-pay surgery.  His death is considered a medical death in an intent to treat analysis, eventhough he died having surgery.

Eventhough this is an intent to treat analysis, NO ONE is interested in categorizing a lot of subjects as having had medical treatment
when in fact they had surgery, and vice versa.  Cross overs are common in clinical trials and discussion of intention to treat analyses
always includes statistics on adherence to intended treatment.  For this reason, many statistical tests have been developed to
compensate for the cross overs that take into account ACTUAL treatment as well intended treatment.  Your data would be
analyzed both by intended treatment and actual treatment. These analyses are of great interest and are often reported in the
news media when the results of clinical trials are released.  These are NOT obscure analyses in a footnote somewhere.  It is
these analyses, you may have understood as a separate category for the actual treatment groups.

The ONLY way to get accurate, valid analyses is to have everyone return for follow-up data collection.  When you return, you
should give information about your actual treatment.  The clinics have forms for this, so the actual treatment can be entered into
the data base along with your clinical data.  If you do not return for follow-up, your data will not contribute to any analyses of
intended or actual treatment.  If you want to show that LVRS works, you should return for your follow-up visits so your data
can be entered into the data base.  The fewer follow-ups we have, the longer it will take us to reach a conclusion about LVRS
based upon scientific data.

Another reason for you to return for your visits is so that your baseline data can be used to help us determine which patients are
likely to benefit from LVRS. You say in your e-mail that Medicare should pay for LVRS by qualified surgeons for qualified patients.
What qualifies a patient for LVRS has been one of the big debates.  If you have had a successful outcome from LVRS and this
shows in your follow-up data, your baseline data can be used to define what kind of patient should qualify for LVRS.

I hope this answers all your questions.

******************************************

RESPONSE FROM ANOTHER MEMBER ENROLLED IN THE NETT STUDY AT UCSD:
******************************************************
Gail Weinmann,

I received a copy of  the information you forwarded to "coalition Pulmonary" regarding the NETT study statistics to date.  There is a
slight discrepancy in the numbers quoted for UCSD.  Several days after I was randomized to "Medical" (April 29th),  I talked to 2
people within the UCSD Pulmonary staff and asked each the ratio between those that have been randomized to medical vs those to surgery.  From each I was told that to date they had randomized 16 people, 11 to Medical and 5 to surgery.
That's a long way from 1:1
*****************************************************
RESPONSE FROM DR. WEINMANN:
I have checked with the Coordinating Center that handles the randomization assignments for NETT.  UCSD has randomized 13 participants, not 16, according to their records, which should be the most accurate of any.  At this moment, there is an imbalance
in treatment assignment at the UCSD center, but not an imbalance study wide, that is across all centers together (51% randomized
to Medicine, 49% to surgery).  The imbalance at the UCSD center is due to the small numbers randomized.

Treatment assignments are randomized according to a particular design to insure that randomizations are truly random and that they
will be balanced across all centers at the end of the study.  Because of the small numbers, at any particular moment, there may be
more participants in one group that the other, but, over time, as new participants are randomized, this will flip back and forth. Other
centers have complained that the randomizations at their center have been so balanced as to be predictable.  The experience at these
centers and the imbalance at UCSD are by pure chance.  By the time UCSD has randomized 50 patients, the numbers should be
very close to 1:1 at any given moment.

I hope this answers your question.

When the bureaucrats and the scientists in the NHLBI (the National Heart, Lung, and Blood Institute) and the HCFA (the agency that
funds Medicare) got together with NIH (the National Institutes of Health) to design the NETT (National Emphysema Treatment Trials),
they decided that they should be "randomized," to assure their validity. "Randomization," as applied to the NETT program, means that,
after a group of patients complete the screening, testing, and waiting process, it will be divided, randomly (like they draw straws) into
two groups: Group 1 will receive the long-awaited (Lung Volume Reduction Surgery) LVRS  and Group 2 will be sent home to
continue living as they had before the testing, screening, etc.  After five or six or seven years, Medicare (or HCFA) will test each
member of Group 1 and each member of Group 2, compare the two, and, thereby,"objectively" measure the efficacy of LVRS. In
other words, THAT was THE PLAN: to get hundreds of patients to agree to undergo extensive screening (including a Pulmonary
Rehab Program, often traveling hundreds of miles to participate) and then flip a coin to see who won and who lost. Well, a funny thing
has happened. Many of those patients who were "randomized out" have opted to break the agreement with Medicare and have had
LVRS performed at different hospitals, paying for it themselves, or getting partial reimbursement from other insurance plans or HMOs
. This results in Medicare having a lot more patients in Group 1 than in Group 2. And, it means that, if they are to maintain their
statistical purity, they have to recruit a lot more people for Group 2, so future coin-tosses aren't going to be fifty-fifty.  Most likely they
will be ten-to-one.  I doubt that it takes a nuclear physicist to comprehend the fact that the longer they pursue this policy, the deeper
will be the hole. If it weren't for the amount of money these folks are wasting, and the negative effect their dumb ideas have on our lives,
the situation would be laughable. How could any reputable research scientist think he could design a program in which hundreds of
human beings would be studied under conditions acceptable only to laboratory mice or guinea pigs? Why would any bureaucrat want
to do this to the people he is supposed to serve?  LVRS offers great hope to those of us who "qualify," but NETT is a farce. If we are lucky, it will soon collapse of its own weight.
Bill Horden

I wrote my representative in congress, asking that he consider requiring Medicare and HFCA to change the NETT program.
Following is his response:

"Dear Mr. Horden:
Thank you for taking the time to contact me regarding the Health Care Financing Administration's (HCFA) rules for the conduct of the National Emphysema Treatment Trial (NETT). I appreciate having the benefit of your views on this matter. As you know, HCFA and
the Heart, Lung, and Blood Institute (NHLBI) are collaborating on a multi-center, randomized clinical study evaluating the effectiveness
of lung volume reduction surgery.  HCFA will cover this surgery in those limited circumstances when it is provided to a Medicare
beneficiary under the protocols established for the study. The criteria for coverage selection was determined by HFCA and the NHLBI.
As you may know, I am a member of the House Appropriations Subcommittee on Labor, Health and Human Services, and Education.
The committee funds the 24 institutes, centers, and divisions that comprise the National Institutes of Health (NIH), the premier medical research institution in the world, and the Center for Disease Control (CDC).  I am aware that Chronic Obstructive Pulmonary Disorder affects millions of Americans and is a leading cause of death. I believe that basic research is of great benefit and can help us better understand this debilitating disorder.  If we are to continue as the world leader in technological advancement, America must continue to support biomedical research. This year, Congress provided $15.6 billion for the NIH, a necessary increase of almost $2 billion over
fiscal year 1998, and $2.6 billion for the CDC, an increase of $226 million.  Specifically, the NHLBI received a $211 million increase
over fiscal year 1998. The federal investment in research to end disease and suffering must remain a national priority.  I will continue to
work hard to ensure that funding for the NHLBI reflects our strong commitment to research. Thanks again for your views. Your insights
help me to better represent you in Congress. Please continue to feel free to inform me of yourthoughts on issues of concern.
Sincerely, Henry Bonilla, Member of Congress"
                                   ---------------------------------------------
My response read as follows:
"Subject: Your letter of Nov. 17, 1998, re NETT, HCFA, NHLBI, etc.
Dear Mr. Bonilla:
I wrote to ask your support in revising the HCFA/NHLBI rules established for the NETT program. You, or one of your staff
members, responded by reciting data that is available from several other sources, (including my original e-mail) then "promising" to
"work hard" to ensure funds for basic research. Your letter conveniently avoided mentioning  the fact that HCFA was eighteen months
late formulating the NETT program and submitting its report to congress.
The NETT program is NOT "Basic Research;" it is, instead, a politically motivated program that presumes to prove or disprove
that which is already demonstrable fact. It is a waste of money and, worse, of human life. LVRS is a proven surgical procedure
and, even if not universally "proven", is much more "applied" than "basic" research.
Since you like statistics, you and your committee members should know that, in the month since I first wrote you, 700 people died
because they were refused lung volume reduction surgery by Medicare and 1600 more, because their HMO or insurer wouldn't
authorize payment "because Medicare doesn't pay."
You should know that, during that period, thousands of patients were admitted to emergency rooms for episodes that could have
been avoided by appropriate treatment that was not offered, and tens of thousands of work days and school days were lost by other
patients and their caregivers. These problems cost us, collectively, several million dollars a day.
The treatment COPD is not nuclear science. There are many drugs and treatments available, and more appear every year, most
developed without government money. Yet you and your committee /subcommittee members, listening to the scientists who would
spend this money, rave on about spending more on "basic research." To those with COPD, you might as well be telling a drowning
man that you will consider initiating another study of the tides.  I am asking that Congress act to utilize the knowledge in which it's
taxpayers (and private patients) have invested heavily; I'm talking about applying that technology you so grandly attribute to our NIH,
and; I'm suggesting we finally start treating patients with all the tools we have at hand. I would be pleased to meet with you, or your staff,
at your convenience, to discuss this further and introduce you to the real world many of us live in.
Bill Horden   San Antonio, TX"

                                  -----------------------------------------------
The membership of the Appropriations Subcommittee on Labor, Health and Human Services, and Education includes the following:
John Edward Porter, Ill., Chairman; David R. Obey, Wis; C.W. Bill Young, Fla;
Louis Stokes, Ohio; Henry Bonilla, Texas; Steny H. Hoyer, Md; Ernest J.
Istook, Jr., Okla; Nancy Pelosi, Calif, Dan Miller, Fla; Nita M. Lowey, N.Y;
Jay Dickey, Ark; Rosa DeLauro, Conn; Roger F. Wicker, Miss; Anne Northup, Ky
You may write via snail mail to:  2358 Rayburn HOB
                                                 Washington, D.C. 20515-6024

Subject: Re: Re>LVRS
Date: Fri, 02 Oct 1998 10:26:36 -0500
From: Cecil Mills <ccmills@pop.nstar.net>
Organization: Retired To: o2@olivija.com
Hello Again.
Well I had my first of two surgerys on June9, 1998 where they removed the upper lobe of my left lung.  After surgery they performed
a breathing test and my stats were the same as before the surgery as far as volume. Now I can go with out my oxygen some, and also
walk with out running out of air.  My o2 setting is about half of what I used before surgery, I am due for a six month check up in
December at which time I hope to learn when they will do the right lung.  Dr Cooper and his staff were just wonderful and made a
stay away from home as plesant as it could be. Any one wanting more infirmation can contact me directly. at ccmills@nstar.netI would
like to thank Olivija for keeping up with my progress, If my next surgery is as ssuccesful as the first, I might be getting off oxygen at
least 50% of the time.   With the condition I was in last year that is a miracle in it self which I thank God for. It has been a slow process getting back to where I was with my exrecise.  Because I could not go to rehab like I did before surgery.  I can tell you I could not have made it had I not had the six months rehab prior to the surgery, that is very important.  Heres hoping that everyone reading this is
having a good breathing day. Thanks Olivija.
Love Cecil

Subject: Re: LVRS
Date: Wed, 20 May 1998 17:23:39 EDT
From: Drag 4 <Drag4@aol.com>
To:  o2@olivija.com
.
Dear Olivija....my LVRS was done in Dec of 1994...so just a little over three years ago...only one lung was done...had radiation on
left breast so they couldnt do the left side.  This was done in St Louis....did my rehab here in Florida...flew up just before Thanksgiving...
was turned down by Dr Patterson as I did not fit the profile....since I was in such bad shape they listened to my cries to reconsider.
And they said they would do one lung...just before the holidays their schedule was very light...maybe a couple couldn't make it...don't
really know.   The first few days after the operation I could really breathe well. That was it.   Stayed in the hospital for a couple of days...then had to stay on for a week before I was released.  My numbers did not improve.   I followed a full routine of exercise that
was brutal...still didn't improve...went back up in May...same numbers...repeat in September....closed the book.  Never came off oxygen.......Recently I had a trans trac and that helped me....also switched to liquid oxygen which was a GREAT  help.   Mornings are always bad...afternoon improve...I can walk around the house slowly...outside its wheel chair time.   I have a wonderful pulmo doctor
who believe in attacking all germs...is up on new medicines...and takes lots of time to listen...and returns phone calls...couldn't ask for anything more.   My prednisone amounts fluctuate...but have been on them too long to ever get off completely...would like to get down
to 10...my eyes are getting bad...skin is bad....face is fat...belly is a little pregnant......I forgot to add...I am 69 and at the last test my
FEV1  is .25.    I feel the oximeter is very important...especially with a TT....also have an ultrasonic nebulizer...great when we are out as
I really can't get much from the puffers.  I spend about one half of my day working on staying alive...
I am very lucky to have a loving and supportive husband .
Alese from Florida

Here is some preliminary info on the results to date in the Canadian LVRS Trial , from
http://www.pulsus.com/Respir/06_01/mill_ed.htm

OBJECTIVE: To review the literature on the surgical treatment of emphysema and to present preliminary results from a pilot study
of lung volume reduction (LVR) surgery.
DESIGN: Case series of consecutive patients referred for LVR surgery. Outcomes were quality of life, pulmonary function and exercise capacity.
SETTING: Two university-affiliated hospitals in Ontario.
POPULATION STUDIED: Patients between the ages of 40 and 75 years with emphysema who had severe airflow limitation,
hyperinflation of the lungs and impaired quality of life.
INTERVENTION: Bilateral reductions with multiple wedge resections of the lung using a linear stapling device with bovine pericardial buttressing were completed via a median sternotomy.
MAIN RESULTS: Of 50 patients referred, 24 underwent LVR surgery. Mean age of the cohort was 63 years. Operative 30-day or in hospital mortality was 8%. Two other patients (8%) died from respiratory failure after LVR within the first year. Postoperative
complications included prolonged air leaks (six of 24), tracheobronchitis (five of 24), mechanical ventilation (four of 24) and
pneumonia (three of 24). Mean length of stay was 18 days (median 12 days). At one year, there was a sustained decrease in total lung capacity from 133% to 123% predicted. There were improvements in forced expiratory volume in 1 s, from 22% of predicted preoperatively to 32% postoperatively, and in 6 min walk performance, from 345 to 381 m. Improvements were also noted in the
quality of life assessments.
CONCLUSIONS: Preliminary results suggest that LVR surgery is feasible and may improve the patient’s quality of life, pulmonary function and exercise capacity. A randomized clinical trial comparing LVR plus the best medical management with the best medical management alone is currently underway to determine the effectiveness of LVR.
 
 

Canadian Lung Volume Reduction Surgery
Cardiothoracic Surgery Discussion Forums
Expenses for the participants of NETT study
 
L V R S PAST, PRESENT AND FUTURE
Lung Volumn Reduction Surgery
LVRS for Chronic Obstructive Pulmonary Disease (COPD)
High Risk of Death after Lung-Volume–Reduction Surgery
National Emphysems Treatment Trial (NETT)
Laser Bullectomy Versus Stapled Lung Volume Reduction
Neural Drive to the Diaphragm After LVRS
Nutritionally Deficient Lung Volume Reduction
Private insurers will pay for LVRS
Concerns About Lung Volume Reduction Surgery Not New
SMOKE SIGNALS Images of LVRS
Summary of research protocol
Surgery for severe COPD
Thoracic Surgery
Ventilatory Impairment after LVRS
Improvement seen in LVRS patients

 
 
 

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last edited 3-13-2002