Don M Posted April 13, 2007 Share Posted April 13, 2007 1011 hours: I called Premera Blue Cross at 0900. I was connected to Saibhan (pronounced Shevan) who is coordinating the review of the FDA 510(k) document approving cyberknife for use on tumors anywhere in the body that I faxed to Premera on Friday April the 6th. She said that she had been in consultation with RNs and doctors who do the medical review there and they all came to a consensus that the document only approves premarketing and not actual treatment of lung tumors. I told her that it would not make sense to market the devices unless the intent of the document was to approve treatment of lung tumors. She said that the FDA has approved treatment of spine and brain tumors but not lung tumors. I told her to compare the FDA approval documents for spine and brain tumors to the one for tumors anywhere in the body and she would see that the language is the same. They use the premarketing language in each document. She said that although the language is the same in the 510(k) documents, there is a separate FDA approval document for use of patients. She said that she did not have access to the specific documents for approval of brain and spine tumor treatment, but they were out there somewhere. (I know she won’t be able to find any other document that the FDA has issued). She also referred to the first paragraph of the FDA response on page 2 of the FDA document saying that the language means that the FDA has not approved the use of lc tumor treatment. I told her that this language is nothing but a cover your *ss statement to make sure that the FDA document is not in conflict with other Federal statues. It has nothing to do with the specific approval. I told her that the first page mentions treatment of lung tumors. She said that this is the page from the company and not the approval by the FDA. Later it occurred to me that the FDA is using what the company submitted as what is being approved. It is part of the approval document and outlines exactly what is approved. I never pointed that out to her, but will when she calls back if there is still going to be more argument about the content of the document. I asked if they would be satisfied if I contacted the FDA and asked the signing officer to send a letter of clarification. She said that would be fine but it would have to be a letter showing that the FDA approves treatment of my tumor with the device. I told her there would be no official FDA approval document for my particular case. The only thing that would be forthcoming is a letter that clarifies that the document in question is an actual FDA approval for treatment of tumors anywhere in the body… that it is not just an approval for marketing. I told her that we were arguing over semantics and that they are holding up my treatment because they want to interpret the language to mean that the device is not intended for patient use and that the only approval is to sell it. I repeated to her that approval solely for marketing does not make any sense. Why would cyberknife centers buy the device if they can’t use it for patients? She said that the treatment is not generally practiced and accepted anywhere in the US. I told her that there must be at least 30 centers that use the device for lung tumors and that is has been widely practiced in the clinical setting for years. She said that the treatment for lung tumors by these centers is done on a trial basis. I said no. It is not being done on a trial basis. It is being done on widely accepted protocols on an everyday basis. She said that there might be other alternatives that are more conservative. I said that it is my only option. I can’t have more surgery and I have already had radiation that did not work. I told her that my provider had sent in copies of my medical records. She said she would look for them and review them too. She said that the robotic arm might miss and hit my good tissue when I was breathing. I told her that the fiducials make sure that the robot arm knows where my tumor is, even during breathing and that absolutely no healthy tissue would be harmed. We bantered back and forth on this for a while. Then I asked her if she had seen the documents on the FDA web page. She said that she had done a web search, but was kind of vague about actually finding any documents. So, I then pointed her to the web page that lists approved devices by the FDA. I directed her to the home page. I told her to type in devices@fda in the search box in the upper left corner. I told her to click on the first link on the next page that comes up, devices@fda. Then we were both looking at the same page together. I told her to note that the database that she was about to enter contains all of the approved and cleared devices approved for use by the FDA. I told her to type in cyberknife at the search box. I then showed her all the approval documents for cyberknife that had been issued. I said that it is clear that these documents are intended to be the FDA documents that approve cyberknife for use. I said that I had clearly shown that the FDA has approved its use for lung tumors. She agreed that it was clear that the documents are intended to be those that the FDA has issued to clear cyberknife for use. She said she wanted to take the information I had shown her and show it to her staff and the medical people at Premera and that she would call me back. I told her that I expected that Premera would concede that the cyberknife treatment is approved for use on lung tumors and that I expect to have a medical necessity review. At one point early in the conversation, she said that they are subject to strict guidelines put on them by the OPM for using such devices, and that they have to be FDA approved. I might have to get the OPM involved to agree with me that the cyberknife is approved for use on lung tumors. My insurance is more or less regulated by the Office Of Personnel Management for the Federal Government. The OPM has the final say in insurance disagreements. I browsed through some other devices approved for use by the FDA and they all use the same premarketing language and they all have a disclaimer about not being in conflict with other federal statues. Their argument that the document approves marketing only and not actual use on patients does not hold water when one views any document that the FDA has issued for any device. The documents all have the same language. If they insist that it is for marketing only, then by their interpretation of the language, brain tumors and spinal tumors cannot be treated with cyberknife and none of the other devices in the database can be used on patients. 1200 hours: I am still waiting for Saibhan to call back. They must be having a really big powwow. Maybe I should get some ativan. 1400 hours: update - Premera called me and they agree that ck is approved for use on lung tumors by the FDA. Now, my provider will have to show that the procedure was medically necessary after the procedure and at claim time. I think I am on solid ground regarding the medical necessity and can now proceed with treatment....YAH! Don M Quote Link to comment Share on other sites More sharing options...
Join the conversation
You can post now and register later. If you have an account, sign in now to post with your account.