BlueCross and BlueShield of Montana Medical Policy/Codes
Myocardial Sympathetic Innervation Imaging
Chapter: Radiology
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: October 25, 2013
Description

Heart failure (HF) is a common and serious condition that carries with it a poor prognosis and burden to the healthcare delivery due to the increasing frequency of prevalence. Several conditions play a role in the development and progression of HF, such as myocardial blood flow and sympathetic innervation. In recent years, diagnostic imaging is within reach to determine the poorly understood physiological processes that have been contributing to HF. Nuclear imaging techniques are yielding new insights to non-invasive measurements, treatment options, and prognosis of HF through assessment of myocardial blood flow, viability, sympathetic innervation, as well as others. Cardiac sympathetic function is commonly altered in many comorbid conditions, as in congestive HF, myocardial ischemia, and diabetes mellitus. The hope is to diagnose left ventricular remodeling, HF, or left ventricular ejection fraction (LVEF) at an earlier stage to provide some restorative therapy and prolong life expectancy. (1, 2, 3)

Regulatory Status

General Electric (GE) Healthcare received 505(b) approval from the U.S. Food and Drug Administration (FDA) in March 2013 for AdreView (Iobenguane I [Iodine] 123) Injection. This approval provided for additional indication for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum ratio of radioactivity uptake in patients with New York Heart Association class II or class III HF and LVEF < 35%. The pediatric patient population was not included and therefore waived in the FDA approval, due to few children with these conditions, and few clinical studies would be impossible or highly impracticable.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Myocardial sympathetic innervation imaging is considered experimental, investigational and unproven, including but not limited to patients with heart failure or left ventricular ejection fraction.

Rationale

In a MedLine search through April 2013, the scientific literature on myocardial sympathetic innervation imaging consists of single-center studies. No randomized trials or larger multicenter trials have been identified.

In 2010, Jacobson et al. performed a prospective study known as the ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure). (4) The authors evaluated 961 patients with New York Heart Association (NYHA) functional class II/III heart failure (HF) and left ventricular ejection fraction (LVEF) < or = 35%. Iodine-123 meta-iodobenzylguanidine [(123)I-mIBG] imaging myocardial imaging (sympathetic neuronal integrity quantified as the heart/mediastinum (H/M) uptake ratio with 4 hour delayed planar images) and myocardial perfusion imaging were done. Subsequently, the subjects were followed for up to 2 years. The objective was to identify those patients with symptomatic HF who would most likely experience cardiac events.

The results were stated as, “A total of 237 subjects (25%) experienced events (median follow-up 17 months). The hazard ratio for H/M > or = 1.60 was 0.40 (p<0.001): the hazard ratio for continuous H/M was 0.22 (p<0.001). Two-year event rate was 15% for H/M > or = 1.60 and 37% for H/A <1.60; hazard ratios for individual event categories were as follow: HF progression, 0.49 (p=0.002); arrhythmic events, 0.37 (p=0.02); and cardiac death, 0.14 (p=0.00606). Significant contributors to the multivariable model were H/M, LVEF, B-type natriuretic peptide, and NYHA functional class. [(123)I-mIBG imaging also provided additional discrimination in analyses of interactions between B-type natriuretic peptide, LVEF, and H/M.”

Later in 2012, the same subjects from the ADMIRE-HF study were evaluated to determine if (123)I-mIBG had the same predictive value across the LVEF spectrum. (5) In systolic HF, both abnormal (123)I-mIBG imaging and reduced LVEF are associated with a higher risk of cardiovascular events. Of the 985 ADMIRE-HF patients, 901 were available for the laboratory-determined LVEFs, ranging from 20% to 58%. The study population mean age was 62 ± 12 years, 80% male, with the majority having NYHA functional class II HF. When comparing those patients with LVEF 35% and >35%, there was no evidence of effect modification of LVEF on the risk associated with love H/M ratio for death or arrhythmic event. The authors concluded additional prospective trials are required to determine the prospective value of (123)I-mIBG imaging for patients with HF and an LVEF > 35%.

A literature search was conducted by Treglia et al. in January 2013 to determine the clinical usefulness of (123)I-mIBG scintigraphy in evaluating the effectiveness of pharmacological treatments in patients with HF. (6) Thirty-three studies were located, with a total sample size of 1,124 patients with HF. The authors concluded that [(123)I-mIBG imaging was successfully used to assess changes in myocardial sympathetic innervation, or neuronal function, caused by several pharmacological interventions for patients with HF.

Clinical Trials for Myocardial Sympathetic Innervation Imaging:

There are no pending or future clinical studies listed in the ClinicalTrials.gov Database for trials to evaluate (123)I-mIBG imaging for patients with HF, congestive HF, LVEF or left ventricular remodeling conditions.

Summary

There is limited prospective or controlled evidence for (123)I-mIBG imaging to determine the predictive value for patients with HF or LVEF. The current evidence is insufficient to permit conclusions regarding the impact on health outcomes. Therefore, myocardial sympathetic innervation imaging is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes
92.05, 428.0, 428.1, 428.20, 428.21, 428.22, 428.23, 428.30, 428.31, 428.32, 428.33, 428.40, 428.41, 428.42, 428.43, 428.9
ICD-10 Codes

I50.20-I50.9, C2IGYZZ, C21YYZZ, C2I6YZZ,  C2IGZZZ, C22GYZZ, C22GZZZ, C22YYZZ, C23GYZZ, C23YYZZ, C72YYZZ, C76Y3ZZ

Procedural Codes: 0331T, 0332T
References
  1. Rischpler, C., Nekolla, S., et al. PET and SPECT in heart failure. Current Cardiology Report (2013 March) 15(3):337.
  2. Boogers, M.J., Fukushima, K., et al. the role of nuclear imaging in the failing heart; myocardial blood flow, sympathetic innervation, and future applications. Heart Failure Review (2011 July) 16(4):411-23.
  3. Chirumamilla, A., and M.I. Travin. Cardiac applications of 123I-mIBG imaging. Seminars in Nuclear Medicine. (2011 September) 41(5):374-87.
  4. Jacobson, A.F., Senior, R., et al. Myocardial iodine-123 meta iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. Journal of the American College of Cardiology (2010 May 18) 55(20):2212-21.
  5. Shah, A.M., Bourgown, M., et al. Journal of the American College of Cardiology (2012 November) 5(11):1139-46.
  6. Treglia, G., Stefanelli, A., et al. Clinical usefulness of myocardial innervation imaging using Iodine-123-meta-iodobenzylguanidine scintigraphy in evaluating the effectiveness of pharmacological treatments in patients with heart failure: an overview. European Review Of Medical Pharmacology Science (2013 January) 17(1):56-68.
History
October 2013  New 2013 BCBSMT medical policy.  Myocardial sympathetic innervation imaging is considered experimental, investigational and unproven, including but not limited to patients with heart failure or left ventricular ejection fraction. 
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Myocardial Sympathetic Innervation Imaging