Insurance Coverage for Laser Lung Surgery in Germany!

[Fictional]

We just found out today that our insurance Premera is willing to make an exception for coverage of our daughter's laser lung surgery with Dr. Rolle this past summer. Yippee! (PTL!) Thank you Olga for sending me your appeal in Canada (Canada was willing to reimburse laser surgeries #2 and #3, but not #1 which was deemed experimental).

I was so surprised they had approved it at the Level 1 of an appeal. I think this means it is more likely that future surgeries will also be covered too. This is a huge financial relief for us. Especially as we have a high deductible plan and here we are again facing the beginning of the year. We would be happy to share our appeal letters, documentation, and accompanying reports by email by any who are interested. Because it is medical information we do not want to post it on the Internet. Please do contact us if you will pursue this.

I had looked up the statistics on appealing insurance denials and Premera and the % success rates are fairly encouraging (25-75% approved, all types of treatments and procedures), so think about it. The nice thing about the process through Premera is that they must answer the Level 1 appeal within 30 days of submission. There is also a Level 2 appeal which a patient can request meeting in person with the committee. If it went to Level 2, we would have had to have more doctors letters and also the state would become involved (as would external consultants).

We only submitted the Hospital and Surgery bills (removed the costs for staying in the hospital, flights etc.), and the total with their calculations of US dollars to Euros came to about $17,000.

Because our daughter had had a previous conventional thoracotomy on the left, we could see how much more lung was removed with conventional (ie stapling) vs. laser thoracotomy. Rolle also uses a muscle sparing technique so her recovery was quicker (easier on her golf swing).

Blessings to you, 'F'

[Olga]

'F', hi, we are just recently back from the vacation and I just saw your message that 'K''s laser surgery in Germany was covered by the insurance. I suggest you to post here a plan/check list for your initial application and the Level 1 of an appeal that you made for Premera coverage - what documents did you provide with the appeals.
I have to comment and correct you on the Canadian situation here too:
You are saying that

Canada was willing to reimburse laser surgeries #2 and #3, but not #1 which was deemed experimental

. It was not exactly like that.
When Ivan was denied the surgery for his multiple lung metastases initially here in Vancouver, Canada they stated that they can not resect all metastases so his situation is unresectable and since only complete resection of all metastases is generally admitted to have a benefit for survival then there is no benefit in the incomplete surgery. When we contacted Dr.Rolle he stated that with his technology the situation is resectable. I submitted a written appeal to our oncologist and surgeon here to have Ivan officially referred for Dr.Rolle surgery. They refused and we left to have Ivan's first surgery on our own with no insurance approval and paid for it out of pocket. So their initial denial was not on the ground that the laser surgery is experimental although they tried this route too but it was relatively easy to deal with - it generally is not experimental as this type of laser is in use as a surgical tool for about 10 years now and there are some publications and FDA approval documents for the previous modifications of this laser (the latest modification that Dr.Rolle created is not approved yet but as a class these lasers are approved). When this first surgery was done Dr.Rolle wrote a report stating that the surgery was indeed the complete so all the expected benefits would apply and we filled the application to be paid for the second lung surgery that was expected to be in a few month by ourselves (although it had to be signed by anyone of Ivan's involved physicians but the only one who did sign it was his family Dr). We went for the second lung surgery still having no answer but when we came back we found out that the payment for the second surgery was approved (I think that the approval was based on a ground that the first surgery was complete but actually there was no reason stated for the approval, the letter was very short and it was said done on a non-precedent basis). Then we asked if the first surgery could be also paid for because the second surgery is paid for in the similar circumstances and they very unexpectedly agreed (that was clearly the good will step on their part as they didn't have to - in our rules when you go without a pre-approval you do not get money). So we got paid for the surgery #1 and #2 (right and left lung separately) and also claimed our travel expenses as tax deductible - going for the medical treatment for the patient and one caregiver.
After that Ivan had something very small but multiple (suspicious for recurrent or new metastases) found on his CT scans again but they were stable for a long period of the time - more then two years, so it was unclear what it was, we were hoping the spots after the laser burning of the smaller mets. Then they started to grow again and this was the point that they (our oncologist and thoracic surgeon) firmly refused to fill the application for the surgery #3 (start of the second round of the surgeries for the right and left lung), their statement was that the first surgery was obviously not a complete resection and there is no proof that partial metastasectomy prolongs survival. They were also weakly mentioning the point of the Dr.Rolle's modification of the laser surgical toll being experimental in US/Canada but it was not the main point (we've been there before so they knew that I would claim the modification being unique and advantageous based on the ground of improved survival statistics by Dr.Rolle's data and his hospital being a center of excellence that justifies an overseas travel). So generally speaking their denial now is based on their belief that the second round surgery in Ivan's circumstances would not have been a complete resection. So we paid for it ourselves again - I kept money they returned to us for the surgeries #1 and #2 sitting in a savings account specifically for the this use, this time we did not submit any application for the insurance as we really have no good argument to rely on and they also changed the rules for the applications and do not accept anything that is not signed by the local supervising oncologist/surgeon.
'F' - if you have found an approval for the previous laser that is in use as a surgical tool in the US now can you please post its number/link here.

[Fictional]

Olga, I would think you could appeal the most recent. If a conventional thoractomy misses tumor, the insurance does not deny the procedure. Also there is a literature suggesting that redo thoracotomies are worthwhile if surgery can wait at least one year between procedures (more rapid means rapidly progressive disease).

Sorry, no link. I actually thought our letter was fairly vague, but I was mentally preparing for the level 2 appeal which involves outside experts. Our case was certainly helped by a letter from Seattle childrens surgeon saying that we should investigate the German laser because conventional resection would require too much lung loss.

If anyone is considering doing this, please contact me by email (drseide "at" gmail.com) and I would be happy to send you pdfs of our cover letter.

Checklist in our letter of appeal:

1. Short summary of medical course - included primary removed with negative margins. Conventional thoracotomy on one side.
2. Letter from surgeon saying thoracotomy on other side not indicated because involvement of several lobes..
3. Surgery with Dr. Rolle because he felt he could remove them all with lung sparing.
4. Our statement: We proceeded with laser resection because they were her only chances for cure and best chance for long term remission.
5. Not experimental - established procedure in Europe, Laser resection approved by FDA in 1990s after LoCicero pubilshed paper
Quote "Twelve lesions were deep seated, could not have been removed by wedge resection or segmentectomy, and would have necessitated lobectomy without this tecnique. With the laser, the lesion could be precisely excised with minimal loss of lung parenchyma."
Excerpt from NCI website
6. References to support aggressive metastasectomy.
7. References to support Axel Rolle
8. Closing comments included: "This was the only possible option available for saving her life, and the surgery was a tremendous success."
9. Enclosures: Clinic report from surgeon, Path report 1st thoracotomy, Articles (Pumonary metastases from soft tissue...Pulonary metastasectomy for osteosarcomas and soft tissue sarcomas, Surgery for multiple lung, Clinical presentation, treatment, Alveoalr soft part sarcoma, Laser resection, Is surgery for...), Hospital discharge summary from Germany, Path report from Germany

[Olga]

To appeal we have to apply for the coverage first and be denied. The we would need to provide something to support the rationale for the redo-surgery in our case. But they changed the requirements for the initial application - it has to be initiated and signed by one of the oncology team and they will not. Probably in US you guys can apply independently but in Canada it is not a private insurance but the government funded and this is their way to save money as people are ready to fly to the moon chasing their hopes.

The article that the redo thoracotomies are worthwhile specifically mentions that it only applies if the consecutive surgery is expected to be a completed resection as well (the longer time between the surgeries is also a factor as it allows the lung to recover but not the only one).
Their argument was that they have all reason to not expect it to be a complete resection this time as in the same situation 3 years ago they agreed with Dr.Rolle's opinion that the resection will be complete and it wasn't. Probably the number of the recurrent mets is of significance. How can I apply for the coverage now if the very first scan after the last surgery #3 shows the signs of the multiple recurrence in the just resected lung - they told me that the surgery will not be complete and it obviously wasn't - and as they said "the advantage of the partial metastasectomy can not be demonstrated", they even had a tumor board review before to deny our idea to go for the surgery. We knew that there is no support and no money when we went for the third surgery but my idea is that in ASPS even the partial metastasectomy can have a survival advantage if the disease is a slow one and it can allow the consecutive surgeries with the goal ether achieve the surgical clearance at some point or hang around long enough for the systemic cure.
I think that your checklist in the letter of appeal is great. We should find the FDA approval doc for the old laser to put it somewhere on this board.

[Fictional]

Learned today from our case manager at Premera Blue Cross that our insurance denial for Dr Rolle's latest surgery is overturned by outside review.

This will help us a lot. I am posting our letter of appeal (our request for coverage was denied when we asked for pre-authorization of the surgery) below. As with the previous, feel free to use it and share it with any who might find it helpful organizing their insurance denials. Unfortunately patients with rare cancers unfairly have many procedures denied (because the insurance companies have no clear policy?)- and ASPS is no exception. Because of some identifying information and the people involved, please do not post it on the Internet. We also included copies of all the papers mentioned in the appeal.

Premera Blue Cross' policy is to respond within 30 days - this was very quick...got an answer back in 2 weeks! We are also hoping that authorization of redo thoracotomy would clear us should she need additional redo's. On the letter of denial, there was an address to request reasons for the denial. We sent this in - and really there were no reasons listed for the denial, just that the thoracotomy was a "non-standard' procedure.

---
Premera Blue Cross
Attention Member Appeal
PO Box 91102
Seattle WA 98111-9202

Member Name: *** *** Subscriber:
Group: Ref. No:

Service: Laser resection of lung metastases

Neil Kaneshiro, MD MHA
Asst Medical Director

Dear Dr. Kaneshiro:

We are writing to appeal Premera's denial of reimbursement for charges sustained during our **-year-old daughter ***'s recent (2/16/09-3/06/09) hospitalization for laser resection of left lung metastases.

Your letter of March 23, you stated that Premera's decision to deny reimbursement is based on lack of available evidence that repeat metastasectomy for recurrent pulmonary metastases provides benefits that outweigh the surgical risks. (Note: Since Premera has previously covered charges for ***'s right metastasectomy that used this same laser resection technique, we will assume that the act that this surgical technique was also used in her present procedure is not at issue in Premera's current denial, and will focus our comments on whether repeat thoracotomy is considered standard therapy for recurrent pulmonary metastases.)

There is actually a clear consensus on the literature supporting the benefits both for prolonged survival and for potential cure with redo thoracotomy for many types of cancers, and particularly for soft tissue sarcomas such as ***'s Alveolar Soft Part Sarcoma (ASPS). We will focus on the literature regarding such sarcomas. In the following paragraphs we will cite 3 papers dealing with repeat thoracotomy for soft tissue sarcomas in general, and one paper and one abstract dealing with repeat thoracotomy in ASPS in particular. There are even more papers we could cite supporting this position. We have enclosed copies of all of these references for your review.

The first paper we will cite is Rehders, et al., (2007), Benefit of Surgical Treatment of Lung Metastasis in Soft Tissue Sarcoma. These authors specifically addressed the value of repeat thoracotomy for patients with recurrent pulmonary metastases from soft tissue sarcomas. Their conclusion was as follows: "Comparing the survival data in these patients [i.e., those who underwent repeat thoracotomy] with the remaining patients [i.e. those with recurrent pulmonary metastases who did not receive repeat thoracotomy], we found that the patients who underwent a repeat operation had a significantly better prognosis (p=.002)... We conclude from these results that repeat resection, if technically feasible, could be a means of achieving long-term survival and should be recommended in patients with recurrence of pulmonary lesions.” Furthermore, in their study 6 of the 13 sarcoma patients who survived for more than 5 years had undergone repeat thoracotomy for recurrent pulmonary metastases. The following figure is taken from their paper, and displays the survival data for those with recurrent pulmonary metastases after thoracotomy who underwent repeat thoracotomy versus those who did not.


(Figure from paper)

“Figure 3. Kaplan-Meier overall survival curves according to repeat surgery because of recurrent pulmonary metastasis. Survival was significantly longer in patients who underwent repeat surgery (P=.002 long-rank test)."

Concerning the issue of surgical benefits versus risk, these authors concluded that: “This policy [i.e., “It seems worthwhile to operate on every patient with lung metastasis unless serious comorbidity or technically unresectable metastatic disease is present”] is underlined by the low complication rate of surgical treatment. In our study, there was no perioperative mortality and no major postoperative morbidity that required reoperation.”

The second paper we will cite is Liebl et al, (2007), Value of Repeat Resection for Survival in Pulmonary Metastases from Soft Tissue Sarcoma. These authors write as follows: “Out of the 29 patients [of the 42 they studied] who suffered from recurrent metastases, 19 underwent at least one repeat resection. In univariate analysis, patients with repeat resections...showed a median survival of 64 months compared to 19 months in all patients with a single resection (p=.0074), which is significantly longer.” They also found that repeat resections for recurrent disease was an independent prognostic factor in multivariate analysis. From this data they concluded that, “It is possible to control disease in patients with recurrent disease for an extended period with repeated pulmonary resection...Long-term survival is possible after resection of pulmonary metastases from soft tissue sarcoma...[and] repeat resection in resectable recurrent disease can lead to long-term survival...Given the continued paucity of meaningful therapeutic alternatives, surgical excision, especially of pulmonary metastases, is currently the only curative option for patients with metastatic disease and should remain the treatment of choice, regardless of age, disease-free interval, the extent of the disease, or the necessary extent of the resection.” Their bottom line: “Patients with repeat resections due to recurrent metastasis show a significantly better prognosis than those with only one resection.”

The third paper we will cite is Chen, et al., (2008), Significance of tumor recurrence before pulmonary metastasis in pulmonary metastasectomy for soft tissue sarcoma. These authors wrote of their operative experience that, “Furthermore, more than 70% of the patients presented recurrences of the tumor even after the pulmonary metastasectomies, which was compatible with the data shown by Downy...According to the frequency of recurrence after pulmonary metastasectomy, relative ineffectiveness of chemotherapy, and the better prognosis of the patients with repeat resection in our study, it would be strongly recommended that pulmonary metastasectomy be performed aggressively and repetitively.” Their bottom line, “Furthermore, patients with repeat metastasectomy for recurrent pulmonary metastasis also presented a significantly longer survival.”

In each of the above studies the authors noted a survival advantage after repeat metastasectomy for those with more indolent disease. ASPS, which is ***'s tumor type, is one of the most indolent of all soft tissue sarcomas, so the case for recurrent metastasectomy is particularly strong in her case.

Because ASPS comprises fewer than 1% of all soft tissue sarcomas, the literature dealing specifically with ASPS is smaller than that which deals with soft tissue sarcomas in general. However, there are two studies supporting recurrent pulmonary metastasectomy for patients with ASPS. The first is Kayton et al., (2006), Clinical presentation, treatment, and outcome of alveolar soft part sarcoma in children, adolescents, and young adults from Memorial Sloan Kettering Hospital. This paper was a retrospective review of 20 patients below the age of 25 with ASPS. In this group 60% (12) had lung metastases, and 9 of the 12 underwent metastasectomy. Between them, these 9 patients had a total of 31 metastasectomies, with a median of 3 and a range from 1 to 8. Overall survival rate among these 9 patients was 78% (7 of 9), with a median follow-up since diagnosis of 136 months (range 21-354 months). Although the numbers are smaller than in the previously cited studies, it is clear from these data that multiple metastasectomies are at least compatible with long-term survival.

The second study was presented as a poster at the 2001 CTOS meeting by Swannie, et al., describing the 16 year retrospective experience with 19 ASPS patients at Royal Marsden Hospital. Of the 19 patients studied, 73% (14/19) developed pulmonary metastases, and of these 9 underwent pulmonary metastasectomy. 4 showed prolonged disease free survival (average follow-up 68.1 months, range 21.8-222.6), and the authors concluded that, There is currently no effective systemic treatment [for ASPS] but resection of pulmonary metastases may be curative and should be pursued aggressively even if repeated metastasectomies are required."

Relating these studies to ***'s case in particular, we can see that her tumors are of the relatively indolent ASPS type, that her primary tumor was removed in January 2008 with negative margins, that her only known sites of metastases have been in the lungs, and that all of the lung lesions that have so far appeared have been resectable by the use of the laser surgical technique used by Dr. Axel Rolle (though several of the deeper lesions have been unresectable by conventional stapling techniques). To reiterate, laser resection was performed for both her right metastasectomy last August and for her repeat left metastasectomy this February because it was the only surgical technique capable of removing her central or deep metastases with negative margins while sparing healthy lung tissue (see enclosed data from our previous successful appeal supporting laser metastasectomy). ***'s surgical course and recovery after both procedures have confirmed the utility and the low morbidity of this approach. Pulmonary Function Testing prior to this surgery revealed a less than 8% decline in Total Lung Capacity after her prior laser thoracotomy, despite the resection with clean margins of 32 nodules. From a surgical standpoint, her current procedure was also a success. All palpable disease (13 nodules) was removed with negative margins, with the removal of very little lung parenchyma. After this procedure *** required no supplemental oxygen at any time. She was fully ambulatory within two days, and was back in school full-time and engaging in normal physical activities within two weeks.

These are the data that we, as both ***'s parents and as physicians, reviewed in making our treatment choice for ***. We are sure that once you have reviewed the data as we have you will conclude that the repeat thoracotomy for metastasectomy currently under appeal was clearly indicated as standard therapy, and that its benefits clearly outweighed the risks. We therefore sincerely request that Premera reconsider its decision to deny coverage for ***'s most recent pulmonary metastasectomy. The surgery resulted in successful clearance of all visible disease in the left lung, it is the only possible option available for saving her life and inducing a long term remission. We would be happy to provide additional documentation upon request. In addition, we authorize any representatives of Premera to contact any of her physicians and surgeons.

Thank you for your time and consideration,

*** MD MA and *** MD

Enclosures:

Rehders, et al., (2007), Benefit of Surgical Treatment of Lung Metastasis in Soft Tissue Sarcoma, Arch Surg 142: 70-75.

Liebl et al, (2007), Value of Repeat Resection for Survival in Pulmonary Metastases from Soft Tissue Sarcoma, Anticancer Research 27: 2897-2902.

Chen, et al., (2008), Significance of tumor recurrence before pulmonary metastasis in pulmonary metastasectomy for soft tissue sarcoma, Eur. J Surgery Sep: 1-6.

Kayton et al., (2006), Clinical presentation, treatment, and outcome of alveolar soft part sarcoma in children, adolescents, and young adults, J Ped Surg 41:187-193.

Swannie, et al., (2001) Alveolar soft part sarcoma in adults: analysis of clinical features and treatment outcome in 19 cases. CTOS Poster.

[Olga]

There are additional articles that can be used in the insurance appeal (Dr.Rolle technique specific) as they provide very competitive survival data suing this technique:

1. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1236-42. Epub 2006 May 2.

Is surgery for multiple lung metastases reasonable? A total of 328 consecutive patients with multiple-laser metastasectomies with a new 1318-nm Nd:YAG laser.
Rolle A, Pereszlenyi A, Koch R, Richard M, Baier B.
Source

Department of Thoracic and Vascular Surgery, Coswig Specialised Hospital, Center for Pneumology and Thoracic Surgery, Carl Gustav Carus University Dresden, Coswig/Dresden, Germany. dr.rolle@fachkrankenhaus-coswig.de

http://www.ncbi.nlm.nih.gov/pubmed/16733151

2. J Thorac Oncol. 2010 Jun;5(6 Suppl 2):S145-50.
Techniques used in lung metastasectomy.
Venuta F, Rolle A, Anile M, Martucci N, Bis B, Rocco G.
Source

Department of Thoracic Surgery, University of Rome Sapienza, Policlinico Umberto I, Rome, Italy. federico.venuta@uniroma1.it

http://www.ncbi.nlm.nih.gov/pubmed/20502250