Developing Story: Consent for ICD, Coverage of MitraClip not an Open-and-Shut Case

Don’t count on headlines; reading the fine print is crucial.

Recently I presented a RACuniversity webcast on the changes to the National Coverage Determination (NCD) for automatic implantable cardioverter defibrillators (ICD), the MitraClip, and more. If you missed it, you can still watch it on demand.

There are a couple interesting points related to this I want to share with you.

First, a bit of trivia. Although I will admit I have not read all of the almost 400 NCDs that the Centers for Medicare & Medicaid Services (CMS) has ever published, the prior NCD for an ICD was the only one I had ever seen that specifically required the patient to provide informed consent. That meant if the patient could not provide informed consent, the procedure would not be covered. Note that this is not merely a measure of the ability to sign the consent. The patient had to be able to understand the risks, benefits, and alternatives of the planned procedure, and then sign the consent.

But they took that requirement out. Instead, all patients receiving an ICD for primary prevention must participate in a shared decision-making encounter using an evidence-based tool. But just like providing informed consent, if the patient can’t participate in that shared decision-making discussion, then the procedure is not covered. I expect we will see more requirements for shared decision-making as time goes by.

The other interesting thing I discovered relates to the MitraClip, which is used during a percutaneous procedure to treat severe symptomatic mitral regurgitation in patients who are not candidates for surgical mitral valve repair or replacement. If a patient has a Medicare Advantage plan from UnitedHealthcare (UHC) and he or she meets the strict requirements of the NCD, the MitraClip can be provided. But if that same patient has commercial insurance provided by UHC, they cannot, because UHC’s own coverage analysis has determined that MitraClip is unproven and not medically necessary. According to their policy guide, there is insufficient evidence demonstrating the long-term efficacy of the device.

This clearly demonstrates the frustration that most of you face every single day when trying to figure out which set of rules to use to determine if a patient should be inpatient or observation. The first patient with Medicare will require use of the two-midnight rule, and the next one, with a commercial plan, requires calling the plan to get an authorization for admission based on their proprietary guidelines.

But in this case, it is potentially a life-and-death situation. You could have a scenario involving two patients with exactly the same problem, with a physician recommending the same procedure, with the same insurer paying their claims, but because they have different plans, one can have the procedure, yet the other cannot.

But let me be clear: I am not saying that CMS is correct to provide coverage and UHC’s policy of non-coverage is wrong. UHC, and all insurers, devote a significant amount of time and effort into reviewing new technologies to ensure that each patient is getting care that appropriate and effective. And in many cases, such as with the MitraClip, the answer is less than clear-cut.

Placing a MitraCLip involves threading a tube up from the groin into the heart, creating a hole between the right and left side of the heart (where a hole should not be), then maneuvering a catheter to the mitral valve, catching the valve just right, then placing a tiny clip on the valve leaflets and hopefully reducing the backflow from the valve. While the treated disease itself is severe and potentially life-threatening, there is a lot of room for complications, both short- and long-term, which could make having no MitraClip the wiser choice. In fact, one of the best pieces of wisdom I have received was that “sometimes it is better to just stand there than to do something.”

Medical history is full of new technologies and medications that were rapidly adopted before the long-term efficacy and dangers were known. One need not look any further than the adoption of Xigris for sepsis to find a medication that was rapidly introduced, at a cost of several thousand dollars per dose, but later found to have no benefit.

But if UHC covers the MitraClip for Medicare Advantage patients, why do they not cover it for their other patients? It’s because UHC does not set medical necessity guidelines for Medicare Advantage patients; they are required to offer to Medicare Advantage patients all services available to patients covered for traditional Medicare. In other words, their hands are tied; in fact, I would bet their coverage experts would say that CMS is doing their patients a disservice by covering MitraClip, not because it is expensive, but because it is unproven.

I have often heard that doctors want to treat all patients “the same,” without regard to their payer source. The coverage issue with MitraClip certainly demonstrates that ignoring insurance coverage may place your patient at risk.

Finally, I need to make a correction from that webcast. If you listened, I referred to modifier QR for the ICD placement; that should be modifier Q0. I am going to blame CMS for that one; the links for the active NCD on the web connect to the transmittals that reference QR. But in 2008, CMS actually changed the modifier required for registry reporting.

Even though it is CMS’s fault, I apologize for the error.

Program Note

 Listen to Dr. Hirsch every Monday on RACmonitor’s Monitor Mondays, 10-10:30 a.m. EST.

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