Tuesday, August 18, 2015

Medically necessary and experimental

Let me describe the journey that I had with that person's nationally recognized health insurance company and what practice they followed in trying to guide the way this person was treated. Insurance companies, or at least this particular one, used the term "medically necessary" in a way that was, ironically, the absolute inappropriate way to use it.

Let's first define what "medically necessary" is. Medicare describes it as: "Health care services or supplies needed to diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine." Those of us reviewing this, and even the health insurance industry, would recognize that a US Food and Drug Administration (FDA)-approved treatment for a particular condition would certainly meet accepted standards of care, because that is how drugs and devices become available in the United States. "Experimental" means that it’s based on untested ideas or techniques and not yet established or finalized.

Here is some background. Imagine a 35-year-old woman who, over a period of 10-15 years, is experiencing progressively frequent and severe migraine headaches. Not every headache is a migraine, but the pattern has changed from having one or two headaches in a typical month to having 15-20 headaches per month. Of those headaches, at least 10 are very clearly migraines. They last more than 4 hours per day. This has been going on for years (therefore, longer than 3 months). This meets the diagnostic definition of chronic migraine, a specific diagnostic category that has not been shown to have the same responsiveness when treated with agents that help episodic migraine and vice versa. The FDA-approved treatment for chronic migraine happens to be one of the forms of botulinum toxin that we have currently available. This is what I recommended to this patient.

Ironically, we got a letter denying treatment with the specific form of botulinum toxin that is FDA approved for chronic migraine because it was considered experimental and not medically necessary.

Let's examine that. We just went over the definitions. This form of botulinum toxin, one of the type A toxins, is the only FDA-approved treatment for chronic migraine. In the prescribing information, which is what the FDA provides for us to learn how to prescribe this medication and guide us, there is no requirement for a person with a diagnosis of chronic migraine to fail other therapies first. There is absolutely no documentation in the prescribing information for botulinum toxin consistent with the steps outlined by this major healthcare insurance company, who said that before they would approve the drug and consider it to be medically necessary and not experimental, the patient had to fail trials of three oral medications, none of which were FDA approved for chronic migraine. Furthermore, each of these medication trials had to last at least 60 days. Imagine that: 60 days. That means the patient would have to incur 6 months' worth of failures before we can consider giving her the only treatment that is FDA approved.

That is crazy because, ironically, the policy that this insurance company was asking me to follow was for an off-label, not medically appropriate, experimental treatment. Yet they were saying that what I was asking for was experimental. The point is that this company—which required steps and medications to be tried prior to the treatment that would be considered standard of care—used terminology such as "medically necessary" and "experimental" to basically put the patient in my practice at risk of failing to respond to those treatments, because they have not been proven to be beneficial in chronic migraine.


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