Ischemic Cardiomyopathy: Disputing LifeVest Coverage Denial

The records have been reviewed. The member is an adult male with a birth date of 02/09/1959. He has a diagnosis of ischemic cardiomyopathy. His treating provider, Maria Costanzo, MD, recommended the Zoll LifeVest (wearable cardioverter defibrillator) for the following dates of service 09/02/2015, 10/02/2015, 12/02/2015, 01/02/2016-02/02/2016 (totaling 4 units).

The carrier has denied coverage for the Zoll LifeVest as experimental and/or investigational and not medically necessary. A letter from the carrier to the member, dated 07/05/2016, which states in part:
“As you can see from the wearable cardioverter-defibrillator coverage policy cited above, a LifeVest is only allowed when it has been determined that an ICD is needed, the criteria

for ICD placement is met, and the ICD placement has been scheduled, but there is a temporary contraindication to receiving it, such as an infection. However, you did not meet the criteria for ICD placement at that time due to your myocardial infarction and stent placement. Based on the ICD coverage policy cited above, an ICD is considered investigational for 40 days following a myocardial infarction and for 3 months following a cardiac revascularization procedure. Once the investigational time period has passed, you must have a contraindication for ICD placement to qualify for the LifeVest. In addition, the wearable cardioverter defibrillator coverage policy states that a LifeVest is considered investigational for patients in the immediate (i.e., less than 40 days) period following an acute myocardial infarction. A LifeVest is not covered as a "bridge" to ICD placement, transplant, or to recovery because of lack of adequate high quality scientific evidence of effectiveness. That is, a LifeVest is not covered during the waiting period between diagnosis of cardiomyopathy and qualification for an ICD or transplant. Page 59 of your 2015 SPD and page 70 of your 2016 Summary Plan Description, under the heading of “What is not covered by the Associates’ Medical Plan,” lists the following as excluded from coverage: “Experimental, investigational and/or treatments and services that are not medically necessary.” Therefore, the request for coverage of the LifeVest remains denied.”

There is a letter from Zoll LifeVest, dated 11/14/2015, that states in part:

“When Coronary artery revascularization is indicated, the LifeVest (wearable defibrillator) device can be prescribed to temporarily protect the patient at risk of SCA during the post CABG/Revascularization periods. The current AHA/HRS and CMS guidelines published in 2006 state that evaluation of the need for an ICD and implantation should be deferred until at least 3 months after revascularization procedures (i.e., surgical bypass grafting or percutaneous angioplasty) to allow adequate time for recovery of the ventricular function following revascularization. The options were to send him home without protection for 90 days, keep him hospitalized during that time period, or send him home with the LifeVest.”

Final External Review Decision:

The carrier’s decision to deny coverage for the Zoll LifeVest (K0606-wearable cardioverter defibrillator) for the dates of 09/02/2015, 10/02/2015, 12/02/2015, 01/02/2016-02/02/2016 as experimental and/or investigational was appropriate.

The Zoll LifeVest (K0606-wearable cardioverter defibrillator) for the dates of 09/02/2015, 10/02/2015, 12/02/2015, 01/02/2016-02/02/2016 was not medically necessary for the treatment of this member’s condition.

The expected benefit of the recommended or requested health care service or treatment is not more likely to be beneficial to the member than any available standard health care service or treatment.

The adverse risks of the recommended or requested health care service or treatment are not substantially increased over those of available standard health care services or treatments.

The Previous denial should be upheld.

Findings:

The member is a 57-year-old man with a new diagnosis of ischemic cardiomyopathy. He was admitted with a new anteroseptal myocardial infarction requiring a left anterior descending artery (LAD) stent. His ejection fraction (EF) was 30% with LAD distribution wall motion abnormalities. He developed dyspnea during his hospital stay and was placed on medical therapy for congestive heart failure (CHF) and left ventricular (LV) dysfunction. Due to his severe LV dysfunction, he was given a wearable cardiac defibrillator (WCD) or LifeVest. There was no mention of non-sustained ventricular tachycardia (NSVT), active infection, or immediate contraindication to an implantable cardioverter defibrillator (ICD). As noted on page 49, November 2015 – “it is entirely possible with aggressive medical therapy his LV function will improve.”

The member has a clear ischemic cardiomyopathy with severely reduced LV Function. The member was placed on medical therapy to attempt to improve his LV function along with appropriate revascularization. If his LV function improves sufficiently, an ICD may no longer be indicated.

The WCD is indicated as temporary therapy for patients with a high risk of sudden cardiac death (SCD). It is primarily used for patients with a planned ICD implantation and/or contraindications for ICD implant. WCDs are considered medically necessary for the prevention of SCD in those who meet the criteria for ICDs but have a temporary contraindication to receiving them, such as systemic infection. The subject member does not currently meet the criteria for ICD implant. He is on minimal medical therapy and has no documented high-risk features. If ventricular tachycardia or easily-inducible arrhythmia were present along with severe LV dysfunction despite medical therapy, a WCD would be indicated pending scheduling of an ICD implant.

The reviewer has considered the literature on WCDs and on ICD implantation for primary prevention. Insurance policy guidelines have also been taken into consideration. Based upon the aforementioned information, together with the clinical features of this case, the requested WCD is not approvable at this time.

This decision is based on existing literature, expert opinion regarding management of cardiac cases, insurance policy guidelines, and the specific clinical features of this case.

The use of a WCD is not always appropriate. Given the clinical features of this case and aforementioned review of information, the benefit of a WCD would be insufficient to warrant coverage. Therefore, coverage of a WCD not recommended for this member.

Therefore, the carrier’s decision to deny coverage for the Zoll LifeVest (K0606-wearable cardioverter defibrillator) for the dates of 09/02/2015, 10/02/2015, 12/02/2015, 01/02/2016-02/02/2016 as experimental and/or investigational was appropriate.

The Zoll LifeVest (K0606-wearable cardioverter defibrillator) for the dates of 09/02/2015, 10/02/2015, 12/02/2015, 01/02/2016-02/02/2016 was not medically necessary for the treatment of this member’s condition.

The expected benefit of the recommended or requested health care service or treatment is not more likely to be beneficial to the member than any available standard health care service or treatment.

The adverse risks of the recommended or requested health care service or treatment are not substantially increased over those of available standard health care services or

treatments.

The Previous denial should be upheld.