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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

04-78000-23

Original Effective Date: 02/15/18

Reviewed: 01/25/18

Revised: 00/00/00

Subject: Dopamine Transporter Imaging with Single-Photon Emission Computed Tomography

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates      
           

DESCRIPTION:

Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT), using radiopharmaceutical ioflupane (123 I) injection, is a neuro-imaging modality being evaluated to improve the differential diagnosis of parkinsonian syndromes.

Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT) is based on the selective affinity of dopamine transporter ligands for dopamine synthesizing neurons, which allows visualization of deficits in the nigrostriatal dopaminergic pathway.

Dopamine transporter ligands include iodine 123 2β-carbomethoxy-3β-(4-iodophenyl) tropane (123I-β-CIT), which is a cocaine analogue with affinity for both dopamine transporter and serotonin transporters. Intravenous 123I-β-CIT requires a delay between injection and scan of about 24 hours. Iodine 123 N-(3-fluoropropyl)-2β-carbomethoxy-3β-(4-iodophenyl)nortropane (123I-FP-CIT) is a fluoropropyl derivate of β-CIT that is selective for brain striatal dopamine transporter, but can also bind to the serotonin transporter. Intravenous 123I-FP-CIT can be injected 3 to 6 hours before the scan (DaTscan). Other ligands with affinity for dopamine transporter include technetium 99m (2β((N,N-bis(2-mercaptoethyl) ethylene diamino)methyl) and 3β-(4-chlorophenyl) tropane (99mTc-TRODAT-1).

Binding of ligands with affinity and specificity for dopamine transporter ligands in the striatum is, in general, reduced in Parkinson disease (PD), genetic parkinsonism, dementia with Lewy bodies (DLB), corticobasal degeneration, progressive supranuclear palsy, and multiple system atrophy. In contrast, striatal DaT ligand binding is expected to be within the normal range in Alzheimer disease, essential tremor, dystonic tremor, orthostatic tremor, drug-induced parkinsonism, psychogenic parkinsonism, and vascular parkinsonism.

Visualization of striatal dopamine transporter binding, through DaT-SPECT, permits assessment of presynaptic dopaminergic deficit. It is proposed that an abnormal DaT-SPECT scan supports the diagnosis of PD, DLB, or other neurodegenerative parkinsonian syndrome, while a normal DaT-SPECT scan in a symptomatic patient supports the diagnosis of a disease not affecting the nigrostriatal dopaminergic pathway. There are, however, a significant percentage of patients with clinically diagnosed PD who do not show reduced DaT-SPECT binding. Patients with clinically diagnosed PD, who present with a normal DaT-SPECT scan, are referred to in the literature as “scans without evidence of dopaminergic deficit” (SWEDD). While many of these patients are ultimately diagnosed with non-PD syndromes, a portion of patients with normal DaT-SPECT imaging are confirmed to have PD by the reference standard. Additional research may shed light on these cases.

Analysis of DaT-SPECT images can be visual, semiquantitative, or quantitative. Because patients typically do not become symptomatic before a substantial number of striatal synapses have degenerated, visual interpretation of the scan is thought to be sufficient for clinical evaluation. A variety of methods are being tested to improve the validity and reliability of ratings, including commercially available software to define the region of interest for analysis and the development of an atlas for visual interpretation.

POSITION STATEMENT:

Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT) is considered experimental or investigational for all indications, including but not limited to:

• Aiding in the diagnosis of members with clinically uncertain parkinsonian syndromes; OR

• Distinguishing between parkinsonian syndromes and essential tremor; OR

• Distinguishing between dementia with Lewy bodies and Alzheimer disease; OR

• Monitoring of disease progression (e.g., parkinsonian syndrome, essential tremor, dementia, dementia with Lewy bodies, Alzheimer disease).

The evidence is insufficient to determine the effects of dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT) on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

78607

Brain imaging, tomographic (SPECT)

Note: Investigational when used to describe dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT)

HCPCS Coding:

A9584

Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 millicuries (Investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

DEFINITIONS:

Parkinsonian syndromes: a group of movement disorders characterized by tremor, bradykinesia, and rigidity.

RELATED GUIDELINES:

FDG-SPECT, 04-78000-15

OTHER:

Other names used to report Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT):

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

DaTscan

DAT-SPECT

Dopaminergic neuroimaging

Dopamine transporter imaging

REFERENCES:

1. American College of Radiology ACR Appropriateness Criteria® Clinical Condition: Dementia and Movement Disorders, Date of origin: 1996; Last review date: 2015.

2. Bajaj N, Hauser RA, Grachev ID. Clinical utility of dopamine transporter single photon emission CT (DaT-SPECT) with (123I) ioflupane in diagnosis of parkinsonian syndromes. Journal of Neuroloy Neurosurgery Psychiatry. 2013 Nov; 84(11): 1288–1295.

3. Berardelli A, Wenning GK, Antonini A et al. EFNS/MDS-ES/ENS [corrected] recommendations for the diagnosis of Parkinson's disease. European Journal of Neurology. 2013 Jan;20(1):16-34.

4. Blue Cross Blue Shield Association Medical Policy Reference Manual Dopamine Transporter Imaging with Single-Photon Emission Computed Tomography 6.01.51, 10/17.

5. Booth TC, Nathan M, Waldman AD et al. The role of functional dopamine-transporter SPECT imaging in parkinsonian syndromes, part 1. AJNR American Journal of Neuroradiology 2015 Feb; 36 (2): 229-235.

6. Booth TC. The role of functional dopamine-transporter SPECT imaging in parkinsonian syndromes, part 2. AJNR American Journal Neuroradiology 2015 Feb;36(2):236-44.

7. Djang DS, Janssen MJ, Bohnen N et al. SNM practice guideline for dopamine transporter imaging with 123I-ioflupane SPECT 1.0. Journal of Nuclear Medicine. 2012 Jan;53(1):154-16.

8. Grosset DG, Tatsch K, Oertel WH et al. Safety analysis of 10 clinical trials and for 13 years after first approval of ioflupane 123I injection (DaTscan). Journal of Nuclear Medicine. 2014 Aug;55(8):1281-1287.

9. McKeith IG, Boeve BF, Dickson DW et al. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100.

10. National Institute for Health and Care Excellence): Dementia: supporting people with dementia and their carers in health and social care Clinical guideline [CG42] Published: 22 November 2006

11. National Institute for Health and Care Excellence): Parkinson’s disease in adults NICE guideline [NG71] Published date: July 2017.

12. Nuvoli S, Spanu A, Piras MR et al. 123I-ioflupane brain SPECT and 123I-MIBG cardiac planar scintigraphy combined use in uncertain parkinsonian disorders. Medicine (Baltimore). 2017 May;96(21):e6967.

13. Postuma RB, Berg D2, Stern M et al. MDS clinical diagnostic criteria for Parkinson's disease. Movement Disorders. 2015 Oct;30(12):1591-601.

14. Suchowersky O, Reich S, Perlmutter J et al. Practice Parameter: diagnosis and prognosis of new onset Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006 Apr 11;66(7):968-975.

15. Vlaar AM, van Kroonenburgh MJ, Kessels AG et al. Meta-analysis of the literature on diagnostic accuracy of SPECT in parkinsonian syndromes. BMC Neurology. 2007 Sep 1;7:27.

16. Walker Z, Moreno E, Thomas A et al. Clinical usefulness of dopamine transporter SPECT imaging with 123I-FP-CIT in patients with possible dementia with Lewy bodies: randomised study. British Journal of Psychiatry. 2015 Feb;206(2):145-152.

17. Ziebell M, Anderson BB, Thomsen G et al. Predictive value of dopamine transporter SPECT imaging with [123I]PE2I in patients with subtle parkinsonian symptoms. European Journal of Nuclear Medicine and Molecular Imaging 2012 Feb; 39:242–250.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/25/18.

GUIDELINE UPDATE INFORMATION:

02/15/18

New Medical Coverage Guideline.

Date Printed: May 24, 2018: 11:57 AM