Case 2 denied: Testosterone therapy in Klinefelter's syndrome

Patient 2 is a 43-year-old-man with hypogonadism due to Klinefelter’s syndrome treated with transdermal testosterone gel. He had done well without adverse drug reactions or side effects of therapy. He had been on the same dose for years; thus, we had decreased the frequency of routine lab testing to annually.

He transitioned over to new insurance. Before agreeing to cover the testosterone therapy, they demanded that I provide copies of his pre-treatment testosterone levels proving that they were below the normal range.

I sent my first letter explaining how such results were unavailable as the patient was diagnosed with Klinefelter’s syndrome at age 13. He had been on some form of testosterone replacement therapy for decades.

We received a response that said that they have a new process for prior authorization. They said that they now require all patients on testosterone to have testosterone levels, complete blood count (CBC) and prostate-specific antigen (PSA) drawn every 3 to 6 months while they are on therapy. Because I had not done this, my request was denied.

I found it interesting how there was no mention of these requirements on any of the previous prior authorization forms.

Were they simply changing the rules on us so they could just find an excuse to deny?

I sent a second much longer letter, six pages total. I explained that I agree with being strict in making sure the diagnosis of hypogonadism is confirmed before initiating therapy. As an endocrinologist, I find myself stopping testosterone in new consult to confirm the diagnosis as often as I actually initiate therapy in patients.

However, in this patient’s case, it does not make any sense at all to stop therapy just to prove that he still has the diagnosis he was born with.

I pointed out that their requirement of expecting that testosterone levels, CBC and PSA be drawn every 3 to 6 months indefinitely is not only unnecessary but is a waste of resources and also not in accordance with current expert consensus guidelines. I included copies of the American Association of Clinical Endocrinologists and The Endocrine Society guidelines for management of adult men with hypogonadism to support my position.

Levels should be drawn after initiation of therapy to monitor for any untoward adverse drug effects. However, once the dose is stable and there is no evidence of side effects of therapy, it is not necessary to continue to follow as often.

My patient’s last PSA in early 2012 was 0.2 ng/mL. For what reason should I have continued to follow that with repeat PSAs every 3 to 6 months?

It is unfortunate and ironic that, because I was being cost-conscious, followed the guidelines and avoided unnecessary lab testing, the insurance used this as an excuse to deny the prescription and punish my patient.

Yes, I could easily have given in and just did what the insurance demands I do. I could just stop the testosterone and prove that he still needs it. It would not be difficult to prove my patient needs testosterone.

If we stopped therapy, his levels would drop quickly. He would feel all the negative effects of testosterone deficiency and symptoms of withdrawal. However, even though we could stop therapy, to me that does not seem like the right thing to do. I wrote them a letter and I told them so.

I have not yet heard back. I am not optimistic. I expect that we will have no choice but to stop therapy to prove he still has his diagnosis.

To avoid similar problems with other patients who have the same insurance, I have changed my practice. I am now beginning to order CBC, PSA and testosterone levels every 3 to 6 months forever — not because I think it is necessary or the guidelines say I should, but because that is what insurance demands that I do.

Cases such as this make no sense. However, an unfortunate truth of health care today is that often physicians are no longer the ones who decide how patients will be managed.

–To be continued–