“We Don’t Cover That. It’s Investigational.”

Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief
Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief

Federal health care reforms now allow patients with preexisting conditions to get health insurance more easily. However, health insurance companies are still in the driver’s seat. Although they may have less say now about whom they cover, they still have complete control about what they cover. 

One way for payers to restrict coverage for procedures is to unilaterally deem them “investigational”. This is apparently possible even when the procedure has been determined to be safe and effective by the FDA, covered by Medicare, and is evidence based. Declaring something “investigational” gives them a convenient excuse to deny coverage. The companies would respond by claiming that their determinations are based on the recommendations of a panel of medical experts. However, there is no transparency to this unilateral decision. In addition, appeals must be made on a case-by-case basis and in writing, which inevitably leads to delays that cause the patient and physician to often take alternative courses that are less in the interest of the patient. 


A prime example of unilateral decision making by insurance companies regarding the status of a treatment is the ongoing determination by some large, national insurance companies that the totally subcutaneous implantable defibrillator (S-ICD) is still “investigational”. Recently, after seven phone calls to a specific insurance company on behalf of a patient, and after a peer-to-peer review by phone, the following letter (at right) was faxed as an urgent appeal. (The letter has been modified to protect patient privacy.)


March 1, 2014

Grievances and Appeals

P.O. Box XXX



Reference No: 

Dear Dr. XXX,

This letter is to request an expedited appeal on behalf of my patient, Mr. XXX, to the decision by XXX Insurance that the S-ICD is “investigational and not medically necessary in all cases”, and that “medical studies we have seen do not show that this type of ICD improves short- or long-term health”. The denial letter is attached.

Mr. XXX is a 25-year-old, previously healthy man who survived an out-of-hospital cardiac arrest. He was hospitalized in XXX and had an extensive cardiac and electrophysiological evaluation that did not demonstrate any etiology. I was contacted on Friday, February 14th, 2014 by his cardiologist, who felt that the patient was an optimal candidate for a totally subcutaneous defibrillator (S-ICD). The patient was discharged with a wearable defibrillator and I saw him the following Monday. Mr. XXX has a clear class I indication for an implantable defibrillator for secondary prevention of sudden death. Given his young age, and no indication for pacing, I agreed with his cardiologist that he was an excellent candidate for the S-ICD, and scheduled his procedure for the following week. Unfortunately, Mr. XXX’s procedure has been cancelled because his insurance has deemed the S-ICD is not a covered benefit despite a peer-to-peer phone conversation that I had with a Dr. XXX last week. His procedure has been rescheduled for XXX.

We have been involved in the research and development of the S-ICD over the past several years and participated in the U.S. IDE trial. We have implanted over XXX S-ICD devices in patients for both primary and secondary prevention. We are currently enrolling patients in the post-market approval study required by the FDA. 

The S-ICD has been approved by the FDA, and is covered by the Centers for Medicaid and Medicare Services. There is safety and efficacy data in the peer-reviewed medical literature that includes the results of the IDE trial that led to FDA approval (Weiss, et al. Safety and efficacy of a subcutaneous implantable defibrillator. Circulation. 2013 Aug 27;128:944-53).

Furthermore, we have had outstanding results with the system at our institution. We have had one patient who was morbidly obese and had a sternal incisional dehiscence that was treated conservatively and did not require removal of the device, and another patient who has had ongoing discomfort from the device. Otherwise, we have had no major complications and have had no defibrillation failures at the time of implant. During follow-up, we have had patients receive appropriate, lifesaving therapies and have not had a patient die unexpectedly. We are also involved in the care of young patients with transvenous implantable defibrillators who have had major complications related to the management of recalled leads, including cardiac perforation during lead extraction. 

I feel strongly that the evidence supports the safety and efficacy of the S-ICD. I also feel strongly that the device should be available to all patients who have an indication for a defibrillator and do not need pacing. It has many advantages over a conventional transvenous device. In particular, the S-ICD should be a covered option available to young patients who are at high risk of long-term transvenous lead complications.

Please reconsider the decision that the S-ICD is “investigational” and not a covered benefit. Please also reconsider your decision not to cover the S-ICD in the case of Mr. XXX.

If you have any questions, please contact me.


Unfortunately, this appeal was also denied.