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qjosea wrote:Thank you for the info. I did some research on my own, based on the paragraph Tri-care used to disapprove. Tri-care policy manual Chap. 1, Sec. 2.1 - unproven drugs, devices, treatments, or procedures. I went to the FDA web site and found devices cleared: Feb. 07 510(k) approved
Resperonics , BIPAP ASV , 510(K) NO. K063533, Attn: Zita A. Yurko, SE decision made 20 Feb 2007, 510(k) summary available from FDA. I hope this information and any letter I get form my Dr. Will help me clear this hurdle.

You might want to draft the letter of appeal, give the letter and copy of infor above to your doctor and ask you doctor to include this information in his statement why the prescribed machine is indicated for your treatment. I find helping doctors to document well with factual information is typically well recived. I have done this on several occassions and it has been well recieved by the doctors.......Keep the letter brief, factual to the point and as if you were the MD signing off. Many doctors appreciate this assistance when it's well done.

elg5cats

You might make sure the coding is right on both ends. I had a denial experience for my titration study--come to find out the sleep lab coded the dx right as sleep apnea but somehow the code the insurance company got was a sleep disturbance code so they denied the claim for the sleep study. Now the case is being put thru coding review to find out what happened. Good luck to you

You're on top of it - bet they'll be surprised at your in depth response. You can't be the only one this is happening to. I feel bad for those who don't have the wherewithal to fight back.

There are a lot of very sensible suggestions re covering all bases in your response. If the ins coy really is looking for a way
out of granting you the machine, then only addressing the 'it is experimental' argument, might leave the way open for yet
another reason to turn you down.

I really like the suggestion of working with your doc to draft the letter & also giving him access to all the info you have
gathered.

Again

Good luck with this - I am sure we all want to see you come up trumps

DSM

qjosea wrote:Thank you for the info. I did some research on my own, based on the paragraph Tri-care used to disapprove. Tri-care policy manual Chap. 1, Sec. 2.1 - unproven drugs, devices, treatments, or procedures. I went to the FDA web site and found devices cleared: Feb. 07 510(k) approved
Resperonics , BIPAP ASV , 510(K) NO. K063533, Attn: Zita A. Yurko, SE decision made 20 Feb 2007, 510(k) summary available from FDA. I hope this information and any letter I get form my Dr. Will help me clear this hurdle.

That is an outstanding find and certainly you are on the right track. As others have already suggested you need to check with you doc 1st to make sure there isn't a very simple error in the paperwork that was sent. The doc could also have forgotten to explain the steps he has taken to arrive at his diagnosis.

Do keep us posted on your quest.

qjosea wrote:Thank you for the info. I did some research on my own, based on the paragraph Tri-care used to disapprove. Tri-care policy manual Chap. 1, Sec. 2.1 - unproven drugs, devices, treatments, or procedures. I went to the FDA web site and found devices cleared: Feb. 07 510(k) approved
Resperonics , BIPAP ASV , 510(K) NO. K063533, Attn: Zita A. Yurko, SE decision made 20 Feb 2007, 510(k) summary available from FDA. I hope this information and any letter I get form my Dr. Will help me clear this hurdle.

Hi

Just a word of caution - line your ducks up well.
The FDA approval num you have provided (K063533) may be for the Respironics Synchrony 2 machine & possibly not the Bipap Auto SV.
The 'Bipap AutoSV' appears to be (K063540) but don't then get that mixed up with a newer unit called the 'Bipap AutoSV
Advanced' which appears to be K090539.

This is just a preliminary verification to help make sure you get the exact numbers. Hopefully some others can further verify the
numbers we are quoting.

Again, good luck

DSM

-2 Some links ...
Respironics Bipap AutoSV K063540 --- http://www.accessdata.fda.gov/cdrh_docs ... 063540.pdf
Respironics Bipap AutoSV Advanced K090539 --- http://www.accessdata.fda.gov/cdrh_docs ... 090539.pdf
Respironics Synchrony 2 K063533 --- http://www.accessdata.fda.gov/cdrh_docs ... 063533.pdf

Also for the record ...

Resmed Vpap Adapt FDA approval is K051364 --- http://www.accessdata.fda.gov/cdrh_docs ... 051364.pdf


-3 - Further issues
As can be seen, the Bipap AutoSV was 1st covered under K063540 (I think (educated guess) this is the case shown in my original post as the HeartPap which resembles the Synchrony 1) and I now can see that the Bipap AutoSV Advanced is the model with the integrated H/H (which I use) & would make it the current model It has a different case to the Synchrony 1. If the current model is the one your doctor is recommending (which I am 100% sure it is) then its FDA num is K090539 &although technically the K063540 num may suffice.

Perhaps some others can validate these findings. We sure don't want to get any detail wrong.

DSM

I copied this from the FDA website. For any person interested in reading I will post the FDA web site link: http://www.fda.gov/MedicalDevices/Produ ... 083797.htm copy and paste and you will locate the device listed below. Also you can click on the K063540 link listed on the FDA web site and it will take you the document I plan on submitting with my appeal and to my Dr.


DEVICE: BIPAP AUTOSV
RESPIRONICS, INC. 510(k) NO: K063540(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 22-FEB-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA

All good advice but i'd still check your codes! if the dx code is somehow wrong then they can say it's experimental treatment--that's what my insurance said for my titration study and it was all because somehow there was a wrong code punched in somewhere between the sleep lab (they had the right code) and the insurance company which had the wrong code (coded as a sleep disturbances something or other and since the dx was coded wrong having the titration study was of course not medically necessary and experimental treatment for that disorder so they refused to pay.)

karessamom wrote:All good advice but i'd still check your codes! if the dx code is somehow wrong then they can say it's experimental treatment--that's what my insurance said for my titration study and it was all because somehow there was a wrong code punched in somewhere between the sleep lab (they had the right code) and the insurance company which had the wrong code (coded as a sleep disturbances something or other and since the dx was coded wrong having the titration study was of course not medically necessary and experimental treatment for that disorder so they refused to pay.)

Agreed about needing just the right diagnostic code. I'm under the impression (right or wrong) that Complex Sleep Apnea is still a controversial diagnosis where at least some insurance companies are concerned. If so, all treatments for a Complex Sleep Apnea DX might arguably be "experimental" to a bean-counting "protector" of the in$urance company'$ preciou$ bean pile...

Respironics suggests exactly which IDC-9 diagnostic codes will work for BiPAP autoSV insurance reimbursement in the link I provided on page one. Notice, at the time that document was written, there was no IDC-9 diagnostic code for Complex Sleep Apnea. However, the periodic breathing and/or central apnea IDC-9 diagnostic code(s) should work I would think.

Some further thoughts as to what may have happened.

This link http://www.accessdata.fda.gov/cdrh_docs ... 090539.pdf

Shows that the approval was only granted for the current (Advanced) Bipap AutoSV on 30 October so I am not at all surprised
if it was declined by the Ins coy last week as I doubt they were aware & maybe still aren't, that the current model has now obtained
full and formal FDA approval.

The changes between the older Bipap AutoSV & the Bipap AutoSV Advanced were sufficient that Respironics reapplied for FDA
approval.

So my up-to-date advice is to quote K090539 as the evidence of FDA approval.

Once again, good luck

DSM

-2
I agree that SWS's link has the required codes and that along with the ref to K063540 + K090539 should be enough to win the day
unless this Ins coy are determined not to agree no matter what evidence is presented. But lets hope it is simply a case of the
newest model's FDA approval only being two weeks old and the Ins coy once presented with the facts, will agree with you too.

ALSO, note that the machine image as it appears in SWS's billing codes link, is the current (Advanced K090539) model of the
Bipap AutoSV. The K063540 approval is for the one shown in my 1st link which in appearance looks like a Synchrony 2 but AFAICT
is no longer sold. Again, lets get all the right ducks lined up in the one row

-3
Download this Medicare doc (it lists their requirements for justifying an E0470 & E0471 device (which the Bipap AutoSV is)). It
should help you prepare your case for your ins coy.

http://www.internetage.ws/cpapdata/manu ... device.doc

The "intended use" for any FDA device apparently needs to match the IDC-9 diagnostic code. Otherwise, the device is by definition employed in an "off label" and potentially uncovered use:

C. Demonstrating that a Particular Use of a Treatment is Not Experimental.

Some insurers will attempt to deny or limit coverage for "off-label" uses of an otherwise FDA-approved drug or treatment. This means that although a drug may be FDA-approved for some uses, it is not specifically approved for treatment of your condition.

http://www.aids.org/atn/a-238-01.html

K090539 FDA Approval Document wrote:INTENDED USE

The BiPAP AutoSV Advanced is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory insufficiency caused by central and/or mixed apneas and periodic breathing.

http://www.accessdata.fda.gov/cdrh_docs ... 090539.pdf

Notice the FDA approval text for the BiPAP autoSV doesn't say anything at all about "Complex Sleep Apnea"? By insurance company definition, I would think that means using the BiPAP autoSV to treat "Complex Sleep Apnea" is an "off label" use for that device---and thus arguably experimental. If it were me, I'd go with the IDC-9 diagnostic codes that Respironics suggests. My hunch is they've been up and down the insurance-coverage road more than just a few times...

SWS has an excellent point re the FDA approval INTENDED USE clause. (note this clause was written by Respironics & not the FDA). It doesnt mention Complex Apnea but does mention Mixed Apnea. This clause is identical for both the original & advanced Bipap AutoSV FDA approvals.

Complex Apnea is where applying cpap therapy to deal with obstructive apneas triggers centrals. Mixed Apnea is where the original sleep study shows both obstructive and centrals.

You will need your Doctor to work through this & the chosen codes so as to meet any potential escape by the ins coy.

Am sure hoping all our delving produces a convincing win for you.

DSM

karessamom wrote:All good advice but i'd still check your codes! if the dx code is somehow wrong then they can say it's experimental treatment--that's what my insurance said for my titration study and it was all because somehow there was a wrong code punched in somewhere between the sleep lab (they had the right code) and the insurance company which had the wrong code (coded as a sleep disturbances something or other and since the dx was coded wrong having the titration study was of course not medically necessary and experimental treatment for that disorder so they refused to pay.)

Very good advice !

Lets hope our collective focus picks up all twists & turns. One great feature of this website

DSM

Thank you all for the great advice. I know with the collective knowledge of all involved within this forum we can get past this hurdle that is thrown by al Ins. Co. I've been working with my sleep apnea since Oct 07, this is just a bump on the road that I will have to over come. Like one great general was quoted:" When one is sorrouned by the enemy that just means you can launch an attack from any position"

The suggestions you have been receiving are great. I would only add one detail. Most insurances require that a BIPAP with backup can only be used if there are more centrals than obstructive apneas. I had a claim denied because the centrals missed this mark by one apnea. Using the device without this % was considered experimental as it did not meet the criteria for the intended use.