investigative or experimental treatment exclusion and scientific advancement

[MonDie]

INSURANCE ROULETTE: THE EXPERIMENTAL TREATMENT EXCLUSION & DESPERATE PATIENTS by Natalie L Regoli

http://www.quinnipiac.edu/prebuilt/pdf/SchoolLaw/LawReviewLibrary/34_22QLR697(2003-2004).pdf

 

I've begun reading it. Although it has a legal focus, it has me wondering about the effect of such health insurance exclusions on scientific advancement. From page numbers 703 and 707, it looks like experimental treatments aren't covered even if they're part of an FDA funded trial, unless your condition is life threatening. This makes sense for the insurer since they want you to get better in the most monetarily efficient way possible. Indeed they only cover them for life threatening conditions because they fear litigation (707-708, Insurers cite outside pressures...).

I'm unsure of the article's age, but I saw this same exclusion twice in my current health insurance plan. How do experimental researchers get patients on-board if their health insurance refuses to cover it? Does the funding organization pay for the procedures out-of-pocket? Wouldn't science progress more rapidly if the insurers would at least cover these experimental treatments with a higher copay -- why do insurers make such an all-or-nothing distinction?

[Prometheus]

Not sure of the USA but in the UK patients volunteering for experimental treatments get looked after extremely well compared to those receiving standard treatment. Clinical research attracts its own funding, and plenty of it, so I imagine they would have little problem covering medical expenses for patients who sign up.

 

I'm guessing though, as I've not seen clinical research state side. I've not heard of problems recruiting patients in the US due to insurance issues, but I have heard of companies taking clinical trials out of western countries to try to escape some of the clinical trials bureaucracy.

[MonDie]

It looks like Quinnipiac University (where I got the article) is in the USA, but I haven't seen it mention study recruitment as an issue yet.

From the citations and the hyperlink it seems to be a paper in their library from 2003-2004.

 

It does say on the page numbered 707 that some insurers have agreed to cover trials funded by the National Institutes of Health, such as the National Cancer Institute. Perhaps in most instances they're able to draw all the subjects they need from just those insurers, but what about exceptionally rare conditions or non-NIH funded trials?

Edited August 15, 2015 by MonDie

[Prometheus]

That seems a fair compromise: insurance companies incur the costs of routine care while the clinical trial team cover the cost of the experimental aspect. Orphan diseases are often funded by universities with tighter budgets so this arrangement would suit them.

 

Maybe the FDA could be lobbied to make a statement to assure insurance companies that all studies approved by them are of equivocal quality as those funded by the NIH? If it's the same process as the UK (and they should at least be similar in that legislation is voluntarily based on the Helsinki Declaration), then the FDA should be the final arbiters of quality anyway, not funding bodies.

[MonDie]

That seems a fair compromise: insurance companies incur the costs of routine care while the clinical trial team cover the cost of the experimental aspect.

How does the insurer know the true cost of it if it's a new procedure? Perhaps that explains their reluctance to cover it. They could reimburse the researchers for a fraction of the standard treatment's cost, with the ratio depending on the relative prospect of success. Edited August 16, 2015 by MonDie

[MonDie]

oops

Edited August 16, 2015 by MonDie