Experimental Treatments

[Guest lschaab]

Does anyone have experience with expenses related to evaluation and prescription costs associated with a clinical trial monitored by the FDA? We have documentation to support that insurance will not pay. Also because our claims department rejected the item for additional information, we have authorization from a physician that the expense is medically necessary. We know that 'experimental' treatments are not eligible, however, we have a signed statement from a physician to satisfy medical necessity, including prevention or treatment of a disease.

Anyone???...

[Sandra Pearce]

Our health plan has denied experimental treatment whether or not the treatment was stated to be medically necessary by the treating physician.

In our Exclusions -

Charges for care, services, supplies, treatments, procedures, devices, drugs or medicines which are determined to be experimental or investigational.

This means that one or more of the following is true:

1. the device, drug or medicine cannot be lawfully marketed without approval of the U.S. Food and Drug Administration and approval for marketing has not been given at the time the device, drug or medicine is furnished.

2. reliable evidence shows that treatment, procedure, device, drug or medicine is the subject of ongoing phase I, II, or III clinical trials or under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis.

3. reliable evidence shows that the consensus of opinion among experts regarding the treatment, procedure, device, drug or medicine is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis.

[Guest lschaab]

I understand that by contract a health plan can exclude certain treatments, etc. However, I am more interested in whether or not treatments monitored by the FDA and all costs associated with the trial can be reimbursed through an FSA. Maybe I wasn't clear in my initial inquiry, sorry about that.

[Guest JerseyGirl]

I'm curious as to why there would be any out-of-pocket expenses associated with participating in an FDA monitored clinical study. In any of the clinical studies I have ever known/heard about- including one for a new asthma medication for which my son was deemed to not be a good candidate- all office visits and medications are provided at no cost. In most cases, the participant is actually paid a small amount for their time. Further, how can you have a prescription for a drug that does not have FDA approval?

[Guest lschaab]

There is no "prescription" for the treatments (which includes administering drugs) and monitoring progress of the patient are part of the trial. The physician is in fact charging the patient more than $2000 / month, and labelling the charges as medical monitoring since they cannot charge for the non-FDA approved drugs. I still do not have any confidence that these expenses can be reimbursed through an FSA, however, when I have a physician authorization that the treatments are necessary to alleviate the patients condition, I have to ponder how to make the call - to reimburse or not to reimburse?

That is my question!