I have a medical problem that could be greatly helped by a device that is now in process of being approved by the FDA. What I am wondering is, do most health insurances cover things like this as long as they are not experimental and once they are actually approved (as long as it’s medically necessary of course). Is there any intermediate status, for example, or once it’s approved does it have the same status as any other long-standing approved device?
This does vary from one health insurance company to another.
However, “FDA approved” does not automatically mean the device/drug is covered, or covered for all instances. In many cases it’s a minimum requirement. More and more, insurance companies are looking for “effectiveness” (read: cost effectiveness) as well as whether or not it works. If a device is approved but costs 10 times what a similar device costs there is a good chance insurance won’t pay for it, especially if the less expensive device is just as or nearly as effective.
So, if this new device is a stunning breakthrough in treatment it will most likely be covered once FDA approved. If, however, it’s a variation on a theme but much more expensive, it may not. Likewise, if there are questions as to whether or not it’s the best therapy for a given situation it may not be covered.
Most insurance companies take their lead from Medicare, which occasionally covers new procedures as soon as the FDA approves them.
Depending on the cost of the device (and you weren’t very specific), you can always rent it or purchase it out of your own pocket, just as you could any other device. Such a thing may also be deducted from your income tax, although IANH&RB, and you might want to check into that.
Robin
Many insurance plans cover “out of plan” procedures and devices (with a hefty deductable, of course), provided you can get a referral. Also, if you have access to a medical Flexible Spending Account, that should help defray some of the costs of your device.
Flexible Spending Accounts (FSAs), if you’re not familiar with them, pull pre-tax money from your paycheck, and can be used for approved medical proceedures and devices. This essentially makes those costs tax-free. The catch is, if at the end of the year, you’ve not used all the money in the FSA, it’s lost. No refund.
That’ll be the day! There’s usually quite a lag after FDA approval and coverage by Medicare.
This device, a camera in a capsule actually, can be used in lieu of abdominal surgery to locate a problem in the small bowel. You just swallow it and it is excreted. You can go about your normal activities as it takes pictures of the GI tract. It was approved in Europe July 2. Tests in NY were completed this Fall. The FDA has promised 6-month approvals because of all the criticism of delaying life-saving drugs etc. too long. It has been 6 months so I hope they keep their promise. I have no idea if it would be as expensive as surgery given the breath-taking cost of medical procedures these days, but the last time I had surgery it was $65,000.00. Also, I can’t imagine that the company, Given Imaging, would pay all the up-front costs of a device that won’t be used because it is no better, and more expensive, than the alternative which is taking out the small bowel and going over all 25 feet inch by inch. As one might imagine, from MY point of view, the camera seems a great alternative. If the problem can be located, it would only require a small incision to correct. Blue Cross in Maine tells me it could still be considered experimental even after approval; Blue Cross in California (where I will travel to have it done if I do) says that once FDA approved they will cover it if medically necessary. They SHOULD be the same, as it is federal employee health coverage, so go figure. So all I have to do is hope that I don’t bleed to death before the FDA gets it’s butt in gear and approves this device.
OK… couple problems here.
First of all, there is an existing endoscopic procedure called an esophagogastroduodenoscopy (EGD for short, and it takes longer to spell than it takes to have done.) that looks at the esophagus, stomach, and duodenum. There’re also imaging studies (like the Upper GI with Small Bowel Follow-Through) that look at the intestine, and our friend the Colonoscopy, and its cousin the Barium Enema. These procedures have been used for years, are quite safe, and relatively non-invasive. (And before anyone accuses me of putting a happy face on these, I’ve had all done to me but the colonoscopy.)
What Given Imaging is going to have to do to gain acceptance from insurance companies is show that their product offers a significant advantage over the procedures currently in accepted use. One possibility (and one that Medicare favors) is limited coverage, meaning that the physician must submit documentation from the medical record that this device was required because (for example) the patient can’t tolerate an EGD and can’t swallow liquids for an upper GI study. Or some such thing, but there would have to be good clinical reason for its use.
Keep in mind, too, that there is a difference between FDA approval and approval for reimbursement. FDA approval means that the device/drug/whatever has been tested and shown to be safe. Approval for reimbursement is a bit trickier. Insurers want to see that the device works on actual patients as well as in clinical trial, and that their money is going to be well-spent.
As I said, if you really want this procedure done with this device, you can have it done, but be prepared to pay for it out of pocket. Even if a claim is submitted, there’s a good chance for denial (although a claim lets the insurer know the procedure was performed, and who knows. They may decide to pay it under an exception. BCBS Federal has been known to do that.).
Good luck!
Robin
Hi Robin. I really appreciate your input because you seem to know about all of this mysterious stuff, e.g. health insurance and these procedures. I failed to mention in my post (my fault) that I have had two lower scopes and two upper; a radio-isotope scan; a barium (yuck) test, with no results. My Gastroentrologist suggests that I wait until I am bleeding to death again and have another endoscope, but he thinks it might be in an inaccessible part of the small bowel as he was not able to see anything twice. That’s why the CapCam seems like such a god-send to me. Also, I could have the test without waiting for this sword hanging over my head to drop. The camera might be able to spot the source of the problem without waiting for the bleeding to start again. If there is anything else I don’t know about that can see the small bowel except cutting me open, I would like to know about it pronto. But if it involves waiting until I have to be rushed 120 miles to the hospital then I’d rather wait until FDA approves the camera. Unfortunately I live on a small island (with a causeway) in the northern-most part of Maine. A paradise, except when you need high-tech medical care.
I’ve had most of this stuff done to me, too, and it is NO FUN!
In a situation like this, where there is a known problem that current imaging modalities can’t find (and these do happen), some insurance companies will pay under what’s called an “exception”. Talk to your insurance company, and have your doctor talk to them about this. Even if they don’t pay for it, it’s still worth the phone call. And don’t stop at the customer service rep; keep going till you get an answer you’re happy with.
BTW, my background is in medical reimbursement and insurance issues, and I’ve processed claims in the past for the BlueCross and BlueShield Federal Employee Program.
Robin
First of all, let me make clear that I understand that from the patient’s point of view swallowing a camera-in-a-capsule is far superior to abdominal surgery. However, some insurance companies are going to look at that and say “Hey, don’t we have barium enemas for this?” and refuse to pay. I’m not saying that’s right, I’m just saying that’s the way it is.
I think the issue will be more “is it effective?” than “is it expensive?”
Just a brief bit about Blue Cross Blue Shield - many people labor under the assumption that BCBS is one big company. It isn’t. It’s a confederation of separate companies who have all agreed to abide by certain rules in order to use the brand name and trademark. BCBS of Maine is a completely separate and independent company from Blue Cross of California (which is also a separate and distinct from Blue Shield of California). They independantly decide what to cover and what not to cover. Usually not much of a problem, except when you get to very new devices, drugs, and procedures. Although you would think that Federal Employees would have some consistency across the nation that is not always what happens in practice.
Now, here’s one possible suggestion. Have your doctor who’s working with you on this problem write to the top person making medical decisions at BCBS of Maine. Do not go through customer service, do not write this letter yourself. Have your doctor do it and explain what has been done already, that it has not been successful, and have him ask to do the new procedure in place of, as you put it, removing the small bowel and going over it inch by inch. Make sure your doctor emphasizes that your life has already been in jeopardy once and you are trying to avoid this situation, as well as the considerable costs of exploratory surgery… Under such circumstances the insurance company may decide to make an exception to their rules and cover the procedure.
I might also point out that BCBS of Maine was bought out by something called “Anthem Insurance Companies”, based in Indianapolis, IN (it was originally BCBS of IN, in fact) so you may wind up writing to Indy to get this approved. But if they said “no” already then you lose nothing by asking for an exception. If they say no again, move to California, at least until you get this problem taken care of.
Hi Broomstick. Well, I already had the barium with no results. I also found out that Given Imaging says the procedure is about the same cost as an endoscopy, which is good news. I am amazed that there should be differences in coverage for federal employees who have insurance with the “same” insurer. I thought all the Health insurers who provide care to government employess had a contract that required consistency in coverage within the same plan. It’s a good thing my parents live in CA because that’s where I’m planning to go, if I can find out what UC Davis plans in regard to this device. I’ve already contacted them. About having it done in Maine, forget it. We are lucky to even have a small hospital 30 miles from where I live. For speed, my best bet is a large medical center, like UC Davis, or Mount Sinai (where they did the U.S. tests), or Boston. What my gastroenterologist says is that whatever it is is located in an area that rarely causes trouble. Most of the time the source can be located with the usual scopes, barium, radioisotopic tests. He says it’s good news they all are negative. At least it doesn’t look like I have cancer or anything like that, just some pain in the ass (no pun intended)congenital defect in a vessel or something.
According to National Public Radio news this morning, this device has been awarded FDA approval and is scheduled to go to market within 90 days. Its cost is expected to be about $450, exclusive of physician fees.
One misconception that Broomstick seems to have is that radiologic and endoscopic imaging can image the entire digestive tract. The intestine alone is roughly 23 feet, give or take, and is quite convoluted. A tube can only go up (or down) so far. Nuclear medicine can’t look for everything, and if internal bleeding is suspected, is useless if the patient isn’t actively bleeding.
One final point about BCBS Federal benefits is that the benefits are fairly consistent among the different state plans. Corporate contracts (standard health plans), OTOH, can and do vary.
Robin
Thank Robins! I keep checking the FDA site but it still isn’t posted as approved as of this morning. That is good news.
No, hon, I don’t have that misconception at all - I work with a medical research outfit with a very competent crew of folks currently investigating various imaging systems for the gastro-intestinal track. If you go back and re-read what I posted, what I actually said what that there are people in insurance companies who don’t know the difference. Given your background, you must know this is true as well as I do. Just because someone works for an health insurance company is no garauntee they have any medical knowledge whatsoever.
My bust, Broomstick, and please accept my humble apology.
And, yes, I know full well that few insurance workers have any real knowledge of anything beyond basic medical terminology.
Robin