I hope NYCEVE will forgive me for appropriating her "Murder By Spreadsheet" headline, but it fit the theme of this diary.
As we've learned from Eve's diaries, including her recent diary about CIGNA delaying the liver transplant for a teenager who ended up dying, insurance companies often delay or deny payments because a treatment is deemed "experimental".
This problem has the potential to affect a large number of us, not just those in need of new livers or modern treatments for cancer, as insurance companies start cracking down on off-label prescriptions.
What are off-label prescriptions? How will the drug and insurance companies screw us this time? Read more after the jump...
When the FDA approves a drug, it also dictates the labeling that describes what conditions the drug can be prescribed to treat and the age of patients for whom it can be prescribed.
Now, a doctor is not legally bound to follow the FDA's labeling of a given drug. If a doctor thinks a patient will benefit from a prescription for a given drug, even if that patient or that patient's symptoms are outside the FDA's labeling of the uses for that drug, the doctor can still write a presciption. That is known as prescribing a drug off-label.
As a recent Slate article describes, one of the most common examples of off-label prescriptions that are clearly helpful to patients occur when doctors prescribe albuterol to asthmatic children under 12 years old. Albuterol is not FDA-approved for use in children under 12. Does that mean that extensive testing has shown the drug is dangerous for children? No. It just shows that the testing has not been conducted. The FDA's labeling for albuterol says:
"Safety and effective dosing of albuterol ... have not been established in children below the age of 12 years."
So the drug company chose not to spend the money for the additional testing of the drug on children. Why should they? They make enough profit selling the drug to people over 12 years old. There isn't powerful motivation for them to spend a ton of money on more clinical trials.
Yet, according to the Slate article, albuterol is the drug most commonly used to treat asthma in children. Obviously, it works. And when you have a severely asthmatic child gasping for breath, you want want works.
The problem is, now you can't count on your insurance company paying for the prescription because they can call it "experimental treatment." This has begun with a crack down on the payment for new drugs used for cancer treatments. As noted in this article:
Health insurers "are pushing back" against the high cost of new specialty drugs by limiting coverage of the drugs to conditions that FDA has specifically approved them as treatments or for conditions for which there is extensive evidence of efficacy in clinical trials, the Wall Street Journal reports.
As Duke University oncologist James Vredenburgh noted:
A lot of patients are being denied potentially effective therapies," adding, "What's happening is totally arbitrary, and it's 100% correlated to when the prices went up. Ten years ago, we never got questioned on our medical decision to prescribe the medicine with the best chance of helping our patients"
Think this will stop just with cancer drugs? Think again. The insurance companies can use the same logic to deny payment for your child's albuterol.
The FDA isn't exactly quick about approving new uses for drugs, either. As noted in this article from the Pittsburgh Tribune-Review:
... aspirin, approved by the FDA as a pain killer, was used to reduce the mortality rate among heart attack victims for years before the FDA sanctioned that use of it...
Through the use of off-label prescriptions, doctors successfully determine the efficacy of drugs on their own and build up a community of knowledge. For example, when it was theorized that stomach ulcers were caused by bacteria, doctors tested this theory through the off-label prescription of antibiotics. As doctors discovered and shared information regarding the efficacy of antibiotics against stomach ulcers, amoxicillin and tetracycline were found useful in the treatment of ulcers without any FDA intervention.
To ask an obvious question, whom do you trust more to make decisions about your health care? The family doctor who knows you, your medical history, and who has years of empirical data in what drugs work for a given condition? Or do you trust Medicare and the insurance companies that are motivated by their own bottom lines?
Let's get back to the doctor quoted in the Slate article:
I can't imagine practicing medicine without the independence to write a prescription as I see fit...
The government has also started making off-label prescription more difficult, through Medicare's effort to control drug costs. Medicare has traditionally supported off-label uses by deferring to doctors when it comes to covering the cost of prescriptions. But in recent years, Medicare started to demand the justification of an off-label prescription with formal evidence, including head-to-head trials against other drugs.
The use of off-label prescriptions is wide-spread. Examples of drugs prescribed off-label in autoimmune diseases include low dose naltrexone (LDN), which is widely used for multiple sclerosis, rheumatoid arthritis, Behcet’s disease, Crohn’s disease, and a variety of other autoimmune conditions, and rituximab, which is used off-label for systemic lupus erythematosus (SLE).
According to Slate, A 2006 study published in the Archives of Internal Medicine showed that in the course of a year, roughly one-fifth of prescriptions for the 169 most common drugs were for off-label uses. That comes out to a 150 million prescriptions per year. The use of off-label prescriptions is so common that a crack-down in payments by insurance companies has the potential to affect all of us.
The bottom line: If your doctor knows from his or her own experience that a given drug will work for you or your child's condition, but that it would require writing an off-label prescription, will your doctor hold back because of the potential for you to get slammed with the full cost of the drug if your insurance company calls the treatment "experimental"?
How many more of us have to suffer "murder by spreadsheet" before we see real health care reform in this country?