Implantable Cardioverter Defibrillators Now Require Shared Decision-Making

Ronald Hirsch, MD reported on this breaking news story during the Feb. 20 edition of Talk Ten Tuesdays. Here are highlights of that reporting.

The Centers for Medicare & Medicaid Services (CMS) released a final decision memo on implantable cardioverter defibrillators, also known as ICDs, to update the national coverage determination, also known as NCD.

Since many readers have non-clinical training, I should explain that an ICD is a small implanted device that is used in patients who are at high risk of abnormal heartbeats, also known as ventricular tachycardia or fibrillation. If the ICD detects such an abnormal rhythm, it gives the patient’s heart an electrical shock to try to terminate the abnormal beating. ICD placement is the seventh most-expensive outpatient procedure that Medicare pays for, at a base rate of $30,960. And when something is expensive, it gets a lot of attention. In fact, in 2015, a total of 500 hospitals had to pay fines of over $250 million for violating Medicare coverage requirements for ICDs.

So, what is new in this NCD that is worth noting? Well, first there are some changes regarding which patients qualify for a device. Those changes are pretty technical, so I would refer readers to review the decision memo for details. The second change is that patients will no longer need to be entered into a registry. CMS previously required that every patient receiving an ICD be entered into a database, whereby researchers could access the data for study.

This means there may be someone in the quality department who will no longer have the task of abstracting all those charts and entering the data online. Readers should find out who that person is and see if they want to join the coding or clinical documentation integrity team and do some fun work for a change.

Now, the third change is the one that will require hospitals to adjust their workflow. For patients having an ICD placed for primary prevention, meaning they have not yet had a dangerous abnormal heart beat, the patient must have what is called a shared decision-making encounter, and that encounter must involve an evidence-based tool.

For most medical procedures, the decision-making consists of the doctor saying the patient needs something done and the patient saying “okay.” But with shared decision-making, the patient goes through an in-depth process of learning about the procedure, how it will help or potentially harm them, the other options, the side effects, and the costs – and then all that is put together with their own personal goals to determine if they should proceed. For example, the person with chronic heart failure who is dependent on others for most activities of daily living and has what they view as a poor quality of life would be eligible for an ICD, but may decide that artificially prolonging their life is not what they want, and therefore decline the ICD.

Importantly, these tools also address something that is rarely discussed: turning the device off. This may need to be considered if the patient elects to get an ICD and then at some point in the future, perhaps as their heart failure progresses or they develop other life-limiting illnesses, determines that their quality of life and goals have changed. At that point, the patient may decide that life-prolonging therapy from an ICD is no longer desired and they could request deactivation of the device. 

While CMS requires the use of a shared decision-making tool, it does not endorse any specific tools. To ease your pain, I have placed a few links to some on my webpage, www.ronaldhirsch.com. You should all take a look as there are tools for many diseases from surgery for a torn knee ligament to surgical treatment of varicose veins.

Finally, while this decision memo has been released as a final version, the NCD for ICDs, 20.4, has not yet been updated on the CMS website. Most changes to NCDs are effective immediately, so now is the time to ensure that your facility is prepared for the new indications and for shared decision-making.

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