A self funded health plan has been asked to
preauthorize a bone marrow transplant scheduled
for next week. The plan specifically INCLUDES
bone marrow as one of the covered transplant
procedures. However, it EXCLUDES experimental
procedures.

The participant is included in a clinical study
at a major hospital. While the FDA has apparently
given its approval to the basic procedure, our
TPA has said that it is still considered experimental
in nature. They recommend we deny the preauthorization.

So, problem #1 is the conflict in plan language, but
to further complicate this issue, our TPA has said that
the stop-loss carrier will not pay on the claim....(if
it is deemed experimental.)

How is this best handled? My initial reaction is to
deny the preauthorization and contact the participant
to let him know of the problem and the appeal rights.

In a perfect world the participant would back out
of the clinical trials, and undergo the normal procedures...
or the stop loss carrier would agree to treat the procedure
as a normal bone marrow transplant.

Suggestions??

It's really going to boil down to what the Plan Sponsor (Employer, in this self-funded case) wants to do. If this preauthorization has been to an external review (hopefully the stop loss carrier has done this, and that's why they are saying they would not pay this if it hits the specific deductible), and has come back as experimental, then the Plan Sponsor is on their own if they want to pay this outside of the plan language. My recommendation is to deny the preauth. If an external review of "prefessionals" deems this experimental in nature, then the Plan has language which addresses this. Deny.

I don't want to disagree with papogi, but I do want to bring up some other issues that the client may want to consider.

First, the fallout in the worksite if the person doesn't get the treatment.

Second, there has been a lot of litigation on this topic, and litigation can be very expensive. I would recommend that you get legal counsel to advise you how the courts in your area of the country have come out on this issue.

I think that it is important to point out that the Stop loss carrier has not said that the procedure will not be covered, the post said that it was the TPA who made the statement. I suggest that you quickly submit a request complete with all the relevant procedure codes and get the answer from the stop loss carrier. The TPA cannot speak for the insurer.

We are in the process of getting the information to
the stop loss carrier to determine their stance.

Another decent idea that was raised by our
consultant was to offer to pay the claim up
to the UCR amount in the area. This would likely
keep us below our stop-loss attachment
point and make the participant happy. I would
still like to see the stop-loss insurer agree
to this ahead of time.

The idea from the consultant is a good compromise. That would work out well if it turns out that the treatment that is now considered experimental proves to have an very high rate of successful outcomes. It also restricts the cost to the plan (somewhat) if it turns out that the drug isn't efficacious.

A few other thoughts...
Since the patient is in a clinical trial, find out exactly what cost the patient is responsible for. Most clinical trials compensate the participants in some way. It is possible that the procedure or the drug that the trial is for will be provided; they may just be looking to cover hospital and ancillary services.

I would also ask WHY they consider it experimental in nature. This will allow you to research find out under the FDA is THEY consider it experimental.

Good luck.