A 47-year-old woman, mother of two, was diagnosed with hypertrophic cardiomyopathy (HCM) during family screening after her sister and brother were found to have HCM. She had no symptoms other than mild palpitations. She had no syncope and no family history of sudden death. Monitoring showed no ventricular arrhythmias. A cardiac MRI showed normal left ventricular size, but low normal systolic function, LVEF 50-55%, asymmetric septal hypertrophy with reverse curve septal morphology, maximum wall thickness of 2.2 cm in the mid anteroseptum, no systolic anterior motion of the mitral valve, and large areas of extensive dense focal mid-myocardial scarring in the anteroseptum, anterior wall, and inferoseptum. The timeline is as follows:
June 13, 2019: She was seen for a second opinion by a cardiologist who is an expert in HCM, and was deemed to be at high risk for sudden cardiac arrest based on her moderate hypertrophy, severe ventricular scarring on MRI, and low normal ventricular function. She was referred for an implantable defibrillator for primary prevention.
June 20, 2019: An electrophysiologist evaluated the patient and agreed that a defibrillator was reasonable. She had no indication for pacing. Given her young age, a subcutaneous implantable defibrillator was recommended and she passed the EKG screening on that day. The patient provided informed consent and was eager to proceed.
August 16, 2019: Her insurance denied authorization, stating that the subcutaneous 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.”
August 22, 2019: A peer-to-peer phone call was held between the electrophysiologist (EP) and a physician from the insurance company. The “peer” was certainly not an EP. The EP was informed that the subcutaneous ICD is still considered experimental by the insurance company. The EP was also informed that the purpose of peer-to-peer calls is only to provide information to the physician, and it was clear that approval via the peer-to-peer review process was futile: “There is nothing I can do … peer-to-peer [with this insurance company] is basically for me to guide you … I can’t override ... the subcutaneous ICD falls out [is denied] unless they are a child at [this insurance company], … or don’t have veins… in the insurance world, FDA approval means they think it doesn’t kill anybody.” The EP was instructed to submit by fax a written expedited appeal that according to state law must be in writing and would be sent to an outside consultant.
August 23, 2019: A five-page written appeal was delivered to the insurance company. It was denied again. Not only was the subcutaneous ICD denied, authorization for any ICD was denied. The insurance company further stated that they do not accept scar burden on MRI as an indication and only consider traditional risk factors.
September 5, 2019: The patient herself then made a second appeal through the Independent Medical Review (IMR). Only then was her procedure approved.
October 8, 2019: The patient underwent successful implantation of the subcutaneous ICD (Figure 1).
October 18, 2019: The patient was seen in the device clinic for follow-up, and was doing well.
November 7, 2019: Four weeks after device implantation, the device clinic was alerted that the patient had received an appropriate shock while sleeping (Figure 2). The husband recalled her moving abruptly away from him while in bed in the middle of the night.
The subcutaneous ICD received FDA approval in 2012 (S-ICD System, Boston Scientific) for use in the same patients who have an indication for a transvenous ICD and who do not have an indication for pacing. It is currently considered a class IIa indication in the ACC/AHA/HRS guidelines. This patient had HCM, a maximum ventricular thickness of 2.2 cm, less than hyperdynamic ventricular function, and severe ventricular scarring on her MRI. She was deemed to be high risk for sudden death by a cardiologist and an electrophysiologist, both who are experts in the use of the S-ICD in patients with HCM. She had a life-saving shock from her defibrillator only four weeks following S-ICD implantation after being repeatedly denied preauthorization for coverage by her insurance company. Sudden death is probabilistic. Sure, this is an anecdotal case, but had the preauthorization process caused just one more month of delay in therapy, or had the device never been approved, the doctors and nurses, not the insurance company, would be left explaining to her two middle school daughters why their mother was found dead in her sleep.
The insurance preauthorization process needs to change. One proposal is for the insurance companies to follow the lead of the Transportation Security Authority (TSA) and allow physicians to apply for a special status similar to TSA PreCheck. Physicians who could demonstrate a consistent practice of appropriate use of therapies in their specialty could be given this special status, which would allow them to shortcut the standard preauthorization process. The insurance companies could decide what the criteria are for this designation, just like they alone decide what the criteria are for preauthorization. This would allow patients under the care of the physicians who have received this special “pre-check” designation to be subjected to fewer barriers and delays in medical treatment.
Disclosure: Dr. Knight reports that he is a consultant, speaker, investigator, and offers fellowship support for Abbott, Baylis Medical, Biosense Webster, Inc., BIOTRONIK, Boston Scientific, Medtronic, and SentreHEART.