This is a personal story. Don’t read any further if you don’t want to hear it. I do promise you it has a great ending, though, if you appreciate black comedy.
As many of you know I have an autoimmune disorder that is quite rare (and shall remain unnamed for the present because that’s not really germane to the point of the story). It’s so rare that studies on medicines that will help the individuals with this disorder are almost never done.
If you have rheumatoid arthritis (RA) there are a lot of new medications, still under patent, that can be prescribed for you. They’re expensive but the insurance companies can’t deny treatment for RA patients by those drugs very easily because the evidence from the the hundreds of studies that have been done is so compelling. Plus the FDA has approved their use for RA.
Often physicians would like to use these same medications for other, similar auto-immune disorders, what is called in the business “off label use.” When they are tried many times people with conditions similar to mine improve. But most insurance companies deny these treatments for people like me for a number of reasons. Typically (and these all have happened to me speaking from experience here) they will deny you for the following reasons:
1. The Insurance Company will dispute your doctor’s diagnosis.
This does not mean that a panel of other doctors will examined you personally (that would be too costly and “inefficient.” Instead, a faceless bureaucrat in an office cubicle without an M.D. to his or her name will make this decision.
Ironically, the more doctors who have examined you over the years and the more times your ailment has been mis-diagnosed before the correct determination of your condition has been made (not uncommon if you do not have disorder that is well known or easily diagnosed) works against you, because the bureaucrats at the insurance company whose job it is to deny treatment of expensive medications can use that record against you.*
So if your doctors don’t figure out your illness correctly the first time around, when they do finally get it right their past “mistakes” (and that isn’t a criticism of doctors because correctly diagnosing which of the myriad auto-immune disorders you have is often not a sure thing) the insurance companies rub their hands in glee because now they have a “paper trail” of reasons why the current diagnosis is wrong.
2. The Insurance Company will claim that the medication your doctor prescribed is not authorized for this use because it has not been FDA approved.
Well, many drugs never get FDA approval for uses other than the illnesses or conditions for which they were originally approved, but doctors have been permitted to use them if they are no longer under patent and thus cheaper than newer medicines.
Ironically, my primary care physician related to me a story in which he had a patient who had been approved for several cheap generic medications on an “off label” use basis. However, when they failed to work he attempted to get permission to treat that patient with a new drug that had been specifically approved by the FDA. A newer, more expensive medication still under patent naturally.
That request for the FDA approved medication was denied by the Insurance company because all the “off label” generic medications hadn’t worked so the insurance company made the independent determination that the newer, more expensive patented drug which did have FDA approval for this patient’s illness would likely not work either. *
3. The Insurance Company will note that there are no definitive, comprehensive studies in the medical literature which demonstrate that the medicine ordered by your doctor is an effective treatment for your condition.
And the rarer your disorder the more likely this will be true, simply because the number of patients to run a study in any one location is too few. Oh there may be anecdotal evidence, and journal articles showing the benefits of the drug on a few patients in a clinical setting with other conditions (one or two of whom may have your particular disorder). Those reports and journal articles, however, usually will not be viewed by the Insurance Company as valid or conclusive enough to justify authorizing this treatment for you.
Of course, you will have the opportunity to appeal the decision of the Insurance Company, but as most doctors can tell you that often would be a waste of time, both yours and theirs. Even now with HCR passed. Why? Because the appeals process will still be controlled by the Insurance Company in most cases, particularly if the insurance company is acting as the trustee of an ERISA employee benefits plan.
ERISA is a federal law which preempts any state law, and it was not changed by HCR. Under ERISA a claim for treatment can be denied by the “trustee” of the benefit plan so long as their action is not held to be “arbitrary and capricious.” So, if they give you an appeal and an “independent doctor” (cough, cough) selected by the trustee of the plan (9 times out of 10 that trustee is the Insurance Company) reviews your file and determines for any reason that any treatment ordered by the doctors who have personally examined you is not needed, you lose. Which brings me back to my story.
My primary care physician wanted to try an older, out of patent drug called IL-2, but his request for this drug for me was denied. Why?
Well even though IL-2 is relatively cheap compared to newer auto-immune drugs (remember it isn’t under patent anymore), it is still not as cheap as prescribing an “off label” medication called Prednisone for my condition.
Prednisone is a corticosteroid similar to cortisone. It suppresses almost all aspects of a person’s immune system making that person more susceptible to cancer, viruses, bacterial infections and any other organism likely to make you sick. It has a number of other serious and nasty side effects. I know. I have been treated primarily with Prednisone for 17 years. It is an unpleasant medication on which to rely.
However, Prednisone costs only a few dollars for ninety 10 mg pills. You can see why the Insurance company would prefer I use it rather than more expensive medications.
Furthermore, people with my specific disorder develop a tolerance for it after a time. I had to stop taking it for a while because it was becoming ineffective even at extremely high doses. As a result I was forced to retire from my job as a lawyer, since stress is one trigger for my symptoms.
I take Predisone now only when my symptoms are so bad (joint pain, nausea, abdominal pain and bloating, diarrhea, chills, fever, vomiting) that I have no choice, and then only for a short period of three days (unlike the past where I took it over a period of 3-4 months at a time).
Unfortunately, even with my limited use of Prednisone over the past 8 years, my tolerance (or resistance) to its benefits is reappearing again. My symptoms are flaring up more frequently and the Prednisone, while it still works while I am taking it, no longer provides as long a gap between flare ups of my worst symptoms. Over the last 2 years my doctor documented that I was on Prednisone 25% of the time. Lately that ratio has increased.
My doctor however is stubborn. He wants me off Prednisone and he has actually discovered a few studies that show IL-2 has proven beneficial in several small clinical studies of individuals with my illness. He also referred me to the top rheumatologist in our city, a well recognized teacher and expert on auto-immune disorders in this area to examine me. This doctor determined that indeed IL-2 might be helpful, but first he wanted to get further objective evidence that I was likely to be a person for whom IL-2 would help.
So the best rheumatologist in my city ordered a number of blood tests including one to check my SED rate and CRP levels. These are being done to bolster the argument for treatment with IL-2.
Thus for several weeks I am to try to avoid prednisone so that we can get an accurate baseline of these blood factors. As I type this I am feeling nauseated, dizzy, bloated, having chills and experiencing a lot of joint pain in various parts of my body. The hope is that with the evidence of the blood tests I will have convincing evidence that IL-2 should be tried as an alternative to my present course of treatment.
Before I left the rheumatologist’s office I asked him if he thought that the Insurance Company would finally approve IL-2 if my blood tests support that it may help me.
“Honestly,” he said. “No. They [the insurance company] will still deny you. But I may be able to get the [manufacturer] to provide you with samples and if those show a benefit then the insurance company may approve it. I’ve had that happen with a few other patients.”
So, you see, I am suffering now in the hopes that the a pharmaceutical company may provide me the medication my insurance company (who has a contractual obligation to pay for my medical treatment) refuses to provide. Ironic, isn’t it? I am forced to rely on the tender mercies of a large multinational pharmaceutical corporation in order to get the treatment I need. In short, I am Blanche DuBois.
I have a friend in Canada who suffers from a serious illness. She told me that she can get the most current drug treatments for her condition without any problem, so long as her doctor fills out a prescription for those meds. She was unable to comprehend that so many of us in America must go through hell simply in the hope that we might be approved for the treatments our doctors wish to provide us, and that in many cases those treatments will still be denied to us. She called it barbaric. I agreed with her.
HCR may help a lot of people who previously couldn’t get any health care, but it hasn’t improved my situation. And I suspect I am not alone. This is not to disparage what the Democrats accomplished in the face of massive efforts by the Republican party and the Insurance lobby to prevent passage of HCR. It is a small reminder though, that we still have a long, long way to go to have a health care system that works like those in other “advanced” and “developed” countries.
* Joseph Heller wrote an entire book about this phenomenon. The title of that novel has made it’s way into the American lexicon: Catch 22. Perhaps you’re familiar with it.
