By Martine G. Brousse (not AI!)
"The Medical Bill Whisperer"
Patient Advocate, Certified Mediator
AdvimedPro
July 15, 2024
A fair number of claims and authorizations are denied under the term "Experimental". What does it mean? Is there anything you can do?
Let's jump in.
A. Definition
It is equivalent to other terms including:
investigational
unproven
not FDA-approved, or "off-label"
not (yet) approved for general use but that may be being studied in clinical trials to determine safety and efficacy
used for "research" not for general medicine
not allowed/covered for the condition, diagnosis, medical need, clinical purpose, way of administration, frequency, dosage, for prescribed use or as prescribed
In a word, any medical, surgical and/or other procedure (or technique), service,
product, lab, drug or device, not currently approved or used for the specific use your Dr prescribed for you, is deemed "investigational"
B. What is means:
1. For your wallet
You have no insurance coverage for such procedure, service, device, Rx, treatment
The full cost is your responsibility
Don't expect any insurance coverage or payment, and to win any appeal (unless...)
2. For your health
Your Dr must explain why such a procedure, service, device, Rx, treatment has been prescribed, as well as the financial consequences if you go ahead, or don't.
You might be given a form to sign, explaining the lack of coverage, and your financial agreement to pursue.
C. There are solutions!
Luckily, there are many instances when an "investigational" authorization or claim denial can be fought, reversed and approved. Here are major reasons for the denial and its solution:
1. Clerical coding error
These happen too often to count, especially for labs. If the procedure or service code does not relate to the diagnosis code, or does not make sense, a denial must be issued by your insurance.
For example, coding a CA-125 lab (to detect certain cancer markers) with "high cholesterol" is a sure "no way!" Or requesting an authorization for an MRI with "urinary tract infection". Although the patient may have all these diagnoses, only the right one will get the positive result.
The solution: correct the code, and resubmit an updated claim to the insurance
2. It's old news
Unless your insurance updates every one of the medical policies it relies on to determine whether something is "experimental" or not on a very regular basis, it does happen that a new FDA-approval or updated "on-label" status occur before your insurance knows - or acts - on it.
The solution: consult the FDA approval list and download the new decision.
3. It's being used, safely and effectively
A large number of drugs, for example, are already being used "off-label", meaning beyond the FDA-approved scope.
Once safety and effectiveness have been documented, your insurance can be asked to waive the time it will take the FDA to approve it
The solution: gather peer-reviewed articles in medical journals, findings from current clinical trials, inclusion in drug reference compendia, results of studies, etc to present as evidence of the safety and effectiveness for your condition
4. It's for "compassionate use"
If your condition is life-threatening or not being cured by conventional methods or available treatments, or if all other efforts have been tried and failed, if you cannot be enrolled in a clinical trial (or there are none available), if the potential benefits outweigh the potential risks, and if the only and only alternative left is "experimental", you and your Dr can apply for an exception based on "compassionate use"
The solution: the FDA has made way for insurances to cover such costs, if all criteria are met and documented.
5. It's part of a clinical trial
In such a case, your physician, along with the team that oversees the administration of the trial will reach an agreement with your insurance
While you will/might still be responsible for certain costs - office co-pays, scans or labs share of cost for example - the drug will be donated by the manufacturer, or entity running the trial.
You will be given detailed literature on who pays for what, how much you can expect to be billed for, as well as the strict schedule of the protocol, appointments (visits, labs, scans etc) to expect, and risks.
Insurance companies usually cover clinical trial costs, as technically, they do not pay for the "experimental" drug or device themselves.
6. The law says
In a number of cases, especially for what are called "Orphan diseases", those with too few victims, no research funding and little public or clinical interest for a cure, there are laws at some States' level that mandate coverage and payment of "experimental" treatments by insurance companies. A good example os that of IVIG treatment for PANDAS patients, children with no set cure but years of proven benefits.
The solution: if you suffer form an orphan disease, or not, consult your State's legislature to see if an "experimental" treatment is mandated regardless of FDA-approval
7. Get your physician/office on board!
Without their help, it will be more difficult to get a denial reversed.
They will need to:
review their coding
Request a "peer-to-peer" call with your insurance company to discuss the specific details of your case, and why the "experimental" label may not apply or should be ignored
help explain and justify to you any true "experimental" treatment or medical service
provide medical records, and other evidence to justify off-label or compassionate use
work out the details to enroll you in a trial
and even refer you to a second opinion in order to further justify an "experimental" prescription.
Martine Brousse was a long-time Billing Manager for Physicians before switching to the side of patients in 2013. The move has allowed her to apply her deep expertise and vast experience of the intricacies of resolving all types of medical bill and claim payment issues in ways that directly and positively impact her clientsʻ finances.
(424) 999 4705 - F (424) 226 1330
@martine brousse 2024 @ the medical bill whisperer 2024
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