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Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DAT-SPECT)

Policy Number: MP-504

Latest Review Date: November 2020

Category: Radiology

Policy Grade: B

POLICY:

Effective for dates of service on or after 10/9/2020

Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) may be considered medically necessary when used for individuals with:

  • clinically uncertain Parkinson disease; OR
  • clinically uncertain dementia with Lewy bodies

Use of dopamine transporter imaging with single-photon emission computed tomography is considered not medically necessary and investigational for all other indications not included above.

Effective for dates of service prior to 10/9/2020

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

  • aiding in the diagnosis of patients 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

DESCRIPTION OF PROCEDURE OR SERVICE:

Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT), using radiopharmaceutical ioflupane injection, is a neuro-imaging modality being evaluated to improve the differential diagnosis of parkinsonian syndromes from non-parkinsonian tremor, as well as dementia with Lewy bodies from Alzheimer disease.

Parkinsonian syndromes

Parkinsonian syndromes are a group of diseases that share similar cardinal signs, characterized by bradykinesia, rigidity, resting tremor, and gait disturbance. Parkinson Disease (PD) is the most common cause of Parkinsonism.

Despite the well-known symptoms of PD, diagnosis is challenging even for experienced clinicians, particularly in early stages of the disease. In addition, other etiologies such as essential tremor, corticobasal degeneration, multisystem atrophy, progressive supranuclear palsy, vascular parkinsonism, and drug-induced parkinsonism can lead to a similar set of symptoms.

One recent approach to improve the accuracry of clinical diagnosis of PD and other parkinsonian syndromes is to evaluate the integrity of dopaminergic pathways in the brain using DaT-SPECT imaging.

Dementia with Lewy Bodies

Dementia with Lewy Bodies (DLB) is a type of dementia characterized by Parkinsonism, visual hallucinations, cognitive fluctuation, sleep disorders, and severe neuroleptic sensitivity. DLB is the second most common form of degenerative dementia; Alzheimer disease, which can have similar symptoms at onset, is the most common.

Diagnosis can be challenging, particularly when patients have multiple comorbidities including cerebrovascular disease and/or Alzheimer disease. As with PD, DLB is characterized by the degeneration of nigrostriatal neurons; as such, DaT-SPECT is also proposed to differentiate DLB from Alzheimer disease.

Dopamine Transporter Imaging With Single-Photon Emission Computed Tomography (DaT-SPECT)

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    (123 I-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 three to six 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 an affinity for DaT ligands in the striatum is, in general, reduced in PD, genetic parkinsonism, DLB, corticobasal degeneration, progressive supranuclear palsy, and multiple system atrophy. In contrast, striatal DaT ligand binding is expected to be within the normal range of Alzheimer disease, essential tremor, dystonic tremor, orthostatic tremor, drug-induced parkinsonism, and psychogenic 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 syndromes, while a normal DaT-SPECT scan in a symptomatic patient supports the diagnosis of a disease not affecting the nigrostriatal dopaminergic pathway.

Analysis of DaT-SPECT images can be visual, semiquantitative, or quantitative. In patients with PD, physical symptoms start after 30% to 50% of dopaminergic neurons have degenerated. Symptomatic patients with would be thus expected to have sufficient abnormality on DaT-SPECT for visual analysis to be adequate for interpretation.  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. Several research centers are developing quantitative and semiquantitative classification methods for the evaluation of DaT-SPECT images.

Anatomic variation in the brain, including vascular lesions, may impede the distribution of the iodine123 tracer and could result in an abnormal scan. Dopamine agonists and levodopa may also affect DaT expression, which could influence the ability of DaT-SPECT to monitor the progression of disease unless these agents are discontinued prior to imaging. Patients with clinically diagnosed PD or DLB, who present with a normal DaT-SPECT scan, are referred to in the literature as having “scans without evidence of dopaminergic deficit.” 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 or DLB by the reference standard. In studies where clinical diagnosis is used as an end point, scans without evidence of dopaminergic deficit are present in 3% to 20% of PD patients. In a study of patients clinically diagnosed with DLB, van der Zande et al (2016) found that 10% of these patients had normal scans. Further research may shed light on these cases.

KEY POINTS:

The most recent literature review was updated through September 9, 2020.

Summary of Evidence

For individuals who have clinically uncertain Parkinson disease who receive DaT-SPECT, the published evidence includes randomized controlled trials (RCTs), cohort studies, and case series studies. Relevant outcomes are symptoms, functional outcomes, and treatment related

mortality and morbidity. In populations with clinically apparent PD, studies of diagnostic accuracy have reported high sensitivity and specificity for PD. Studies of clinical validity in the target population of clinically uncertain PD are limited by gaps in study design, conduct, and relevance. Evidence on clinical utility in the target population includes an RCT showing no significant difference in outcomes over time between patients who received a DaT-SPECT scan and those who did not. The evidence is insufficient to determine the effects of technology on health outcomes.

For individuals who have clinically uncertain dementia with Lewy bodies who receive DaT-SPECT, the published evidence includes RCTs, cohort studies, and case series studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and morbidity. No such studies with the optimal reference standard to assess clinical validity have been performed in the target population of clinically uncertain dementia with Lewy bodies. No studies have directly evaluated the effect of DaT-SPECT on health outcomes in the target population. The evidence is insufficient to determine the effects of technology on health outcomes.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

2018 Input

Clinical input was sought to help determine whether the use of DaT-SPECT in individuals with clinically uncertain Parkinson disease or clinically uncertain dementia with Lewy bodies would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 3 respondents, including one specialty society-level response and two physician-level responses identified through specialty societies.

In individuals who have clinically uncertain PD who receive DaT-SPECT, clinical input supports that DaT-SPECT is clinically useful when a negative result on DaT-SPECT is used to inform treatment decisions by reducing or avoiding unnecessary dopaminergic therapy. Clinical input highlights that the published RCT also reported changes in management following DaT-SPECT imaging that may translate to improvements in health outcomes over time, and the one-year study follow-up may be too short to demonstrate significant improvement in quality of life in a slowly progressive disease such as PD. Clinical input further supports that DaT-SPECT offers clinically valid diagnostic information about the presence or absence of functional loss in the dopamine system (ie, nigrostriatal degeneration) and is clinically useful for clinically uncertain Parkinson syndrome when a negative result on DaT-SPECT is used to inform treatment

decisions by reducing or avoiding unnecessary dopaminergic therapy.

In individuals who have clinically uncertain dementia with Lewy bodies who receive DaT-SPECT, clinical input supports that DaT-SPECT is clinically useful when a positive result on DaT-SPECT is used to inform treatment decisions by avoiding potentially harmful use of

neuroleptics which may be used in dementia patients. Clinical input noted that DaT-SPECT offers clinically valid diagnostic information about the presence or absence of functional loss in the dopamine system (ie, nigrostriatal degeneration) and is clinically useful for clinically uncertain dementia with Lewy bodies using a chain of evidence where a positive result on DaT-SPECT is used to inform treatment decisions by avoiding potentially harmful use of neuroleptics typically used in dementia patients.

Practice Guidelines and Position Statements

American College of Radiology

In 2019, the American College of Radiology updated the appropriateness criteria for movement disorders and neurodegenerative diseases. The College categorized Ioflupane SPECT/CT as 'may be appropriate' for initial imaging of Parkinsonian syndrome. A strength of evidence rating was not given for this statement.

The American College of Radiology (2019) updated the appropriateness criteria for dementia.The College categorized Ioflupane SPECT or SPECT/CT brain as 'may be appropriate' for initial imaging for suspected dementia with Lewy bodies.

American Academy of Neurology

The 2006 practice parameters (reaffirmed in July 2013) from the American Academy of Neurology (AAN) state that β-CIT and IBZM  (iodobenzamide) SPECT are possibly useful in distinguishing PD from essential tremor (5 Class III studies). There was insufficient evidence to determine if these modalities are useful in distinguishing PD from other forms of Parkinsonism.

Society of Nuclear Medicine and Molecular Imaging

In 2011, the Society of Nuclear Medicine, now called the Society of Nuclear Medicine and Molecular Imaging, provided practice guidelines for DaT-SPECT. The guidelines stated that the main indication for DaT-SPECT is striatal DaT visualization in the evaluation of adults

with suspected parkinsonian syndromes to help differentiate essential tremor from tremor due to presynaptic parkinsonian syndromes (PD, multisystem atrophy, progressive supranuclear palsy). Other indications are the early diagnosis of presynaptic parkinsonian syndromes, differentiation of presynaptic parkinsonian syndromes from parkinsonism without a presynaptic dopaminergic loss (eg, druginduced parkinsonism, psychogenic parkinsonism), and differentiation of DLB from Alzheimer disease. The guidance stated that visual interpretation of the scan is usually sufficient for clinical evaluation, where the striatal shape, extent, symmetry, and intensity differentiate normal from abnormal. For semiquantitative analysis, each site should establish its own reference range by scanning a population of healthy controls or by calibrating its procedure with another center that has a reference database.

Movement Disorder Society

The Movement Disorder Society’s (MDS) diagnostic criteria for PD from 2015 are intended for use in clinical research but can be used to guide clinical diagnosis. MDS considers clinical expert opinion to be the criterion standard to diagnose PD and that diagnoses are usually made clinically without need for ancillary diagnostic testing. Methods that may become available as knowledge advances are diagnostic biochemical markers, anatomic neuroimaging, and methods to detect alpha-synuclein deposition. MDS noted that, although dopaminergic neuroimaging can help to distinguish parkinsonism from PD mimics like essential tremor, “it does not qualify as a criterion for the differentiation of PD from other parkinsonian conditions like atypical parkinsonian syndromes.”

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence published guidance on the diagnosis and management of PD in 2006, which was updated in 2017. The 2006 guidance stated that 123I-FP-CIT SPECT should be considered for people with tremor where essential tremor cannot be clinically differentiated from parkinsonism (based on studies with level of evidence 1a or 1b); this guidance is continued in 2017 recommendations. In addition, the 2006 guidance stated that 123I-FP-CIT SPECT should be available to specialists with expertise in its use and interpretation (based on level of evidence IV, expert opinion).

The Institute updated its guidance on dementia in 2018. It recommended that 123I-FP-CIT SPECT be used to help establish the diagnosis in those with suspected DLB if the diagnosis is uncertain.

Dementia of Lewy Bodies Consortium

The Dementia of Lewy Bodies Consortium published clinical guidelines on diagnosis and management in 2017, based on American expert opinion. The guidelines stated that reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT is an indicative biomarker. As such, dementia with abnormal DaT-SPECT imaging would be classified as possible DLB. Presence of an additional core clinical feature (fluctuating cognition, recurrent visual hallucinations, REM sleep disorder, parkinsonism motor abnormalities) in addition to dementia and abnormal DaT-SPECT imaging would allow classification as probable DLB. It was noted that patients with autopsy-confirmed DLB may have normal DaT-SPECT imaging.

U.S. Preventative Service Task Force Recommendations

Not applicable

KEY WORDS:

DaTscan, DAT-SPECT, 123I-Ioflupane, Iodine I-123 ioflupane diagnostic study, dopamine transporter SPECT using 123I-Ioflupane, FP-CIT SPECT, [123I]-FP-CIT SPECT imaging

APPROVED BY GOVERNING BODIES:

In 2011, DaTscan™ (GE Healthcare, Chicago, IL) was approved by the U.S. Food Drug Administration through a new drug application and is “indicated for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes. In these patients, DaTscan may be used to help differentiate ET [essential tremor] from tremor due to parkinsonian syndromes (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations.”

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:               78803  Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); tomographic (SPECT) (Effective 01/01/20) 

           

HCPCS Codes:          A9584             Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 millicuries

PREVIOUS CODING:

CPT Codes:               78607  Brain imaging, tomographic (SPECT) (Deleted 12/31/19)

REFERENCES:

  1. Adler CH, Beach TG, Hentz JG, et al. Low clinical diagnostic accuracy of early vs advanced Parkinson disease: clinicopathologic study. Neurology. Jul 29 2014; 83(5):406-412.
  2. American Academy of Neurology. Neurology 2006; 66(7):968-75. [Practice Guideline]. 2006/04/12. Available online at: www.neurology.org/content/66/7/968.full.pdf
  3. American College of Radiology (ACR). ACR Appropriateness Criteria®: Dementia and Movement Disorders. 2014; www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/DementiaAndMovementDisorders.pdf
  4. American College of Radiology (ACR). ACR Appropriateness Criteria®: Dementia and Movement Disorders. 2015; acsearch.acr.org/docs/69360/Narrative/. Accessed August 23, 2016.
  5. Bairactaris C, Demakopoulos N, Tripsianis G et al. Impact of dopamine transporter single photon emission computed tomography imaging using I-123 ioflupane on diagnoses of patients with parkinsonian syndromes. J Clin Neurosci 2009; 16(2):246-52.
  6. Bajaj N, Hauser RA, Seibyl J, et al. Association between Hoehn and Yahr, Mini-Mental State Examination, age, and clinical syndrome predominance and diagnostic effectiveness of ioflupane I 123 injection (DaTSCAN) in subjects with clinically uncertain parkinsonian syndromes. Alzheimers Res Ther. 2014; 6(5-8):67.
  7. Bega D, Gonzalez-Latapi P, Zadikoff C, et al. Is There a Role for DAT-SPECT Imaging in a Specialty Movement Disorders Practice? Neurodegener Dis. 2015; 15(2):81-86.
  8. Benamer TS, Patterson J, Grosset DG et al. Accurate differentiation of parkinsonism and essential tremor using visual assessment of [123I]-FP-CIT SPECT imaging: the [123I]-FP-CIT study group. Mov Disord 2000; 15(3):503-10.
  9. Berardelli A, Wenning GK, Antonini A et al.  EFNS/MDS-ES recommendations for the diagnosis of Parkinson’s disease.  Eur J Neurol 2013; 20(1):16-34.
  10. Berg D, Adler CH, Bloem BR, et al. Movement Disorder Society criteria for clinically established early Parkinson's disease. Mov Disord. Oct 2018; 33(10):1643-1646. 
  11. Bhatia KP, Bain P, Bajaj N, et al. Consensus Statement on the classification of tremors from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. Jan 2018; 33(1): 75-87.
  12. Booij J, Dubroff J, Pryma D, et al. Diagnostic performance of the visual reading of 123I-ioflupane SPECT images when assessed with or without quantification in patients with movement disorders or dementia. J Nucl Med. May 04 2017.
  13.  Booij J, Dubroff J, Pryma D, et al. Diagnostic performance of the visual reading of 123I-ioflupane SPECT images when assessed with or without quantification in patients with movement disorders or dementia. J Nucl Med. Nov 2017; 58(11):1821-1826. 
  14. Brigo F, Matinella A, Erro R et al. [(123I]FP-CIT SPECT (DaTSCAN) may be a useful tool to differentiate between Parkinson's disease and vascular or drug-induced parkinsonisms: a meta-analysis. Eur J Neurol 2014.
  15. Brigo F, Turri G, Tinazzi M. 123I-FP-CIT SPECT in the differential diagnosis between dementia with Lewy bodies and other dementias. J Neurol Sci. Dec 15 2015; 359(1-2):161-171.
  16. Burke RE, O'Malley K. Axon degeneration in Parkinson's disease. Exp Neurol. Aug 2013; 246:72-83.
  17. Catafau AM, Tolosa E. Impact of dopamine transporter SPECT using 123I-Ioflupane on diagnosis and management of patients with clinically uncertain Parkinsonian syndromes. Mov Disord 2004; 19(10):1175-82.
  18. Darcourt J, Booij J, Tatsch K et al. EANM procedure guidelines for brain neurotransmission SPECT using (123) I-labelled dopamine transporter ligands, version 2. Eur J Nucl Med Mol Imaging 2010; 37(2):443-50.
  19. Djang DSW, Janssen MJR, Bohnen N. SNM Practice Guideline for Dopamine Transporter Imaging with 123I-Ioflupane SPECT 1.0. 2011. Available online at: interactive.snm.org/docs/123I_ioflupane_SPECT_Practice_Guideline_JNM_Edit_FINAL.pdf.
  20. Elahi FM, Miller BL. A clinicopathological approach to the diagnosis of dementia. Nat Rev Neurol. Aug 2017; 13(8):457-476.
  21. Erro R, Schneider SA, Stamelou M, et al. What do patients with scans without evidence of dopaminergic deficit (SWEDD) have? New evidence and continuing controversies. J Neurol Neurosurg Psychiatry. Mar 2016; 87(3):319-323.
  22. Fahn S, Oakes D, Shoulson I, et al. Levodopa and the progression of Parkinson's disease. N Engl J Med. Dec 9 2004; 351(24):2498-2508. 
  23. Galvin JE. Improving the clinical detection of Lewy body dementia with the Lewy Body Composite Risk Score. Alzheimers Dement (Amst). Sep 01 2015; 1(3):316-324.
  24. GE Healthcare. DaTscan Ioflupane I123 Injection Full Prescribing Information. 2015; www.gehealthcare.com/en/products/categories/nuclear_imaging_agents/datscan. Accessed May 10, 2018.
  25. Harvey HB, Watson LC, Subramaniam RM, et al. ACR Appropriateness Criteria Movement Disorders and Neurodegenerative Diseases. Available at https://acsearch.acr.org/docs/3111293/Narrative/. American College of Radiology. Accessed September 17, 2020.
  26. Hauser RA, Bajaj N, Marek K, et al. Sensitivity, specificity, positive and negative predictive values and diagnositic accuracy of DaTscan (Ioflupane i123 injection): Predicting clinical diagnosis in early clinically uncertain parkinsonian syndrome. J Neurol Stroke 2014; 1(1)00003 //medcraveonline.com/JNSK/.
  27. Hubbuch M, Farmakis G, Schaefer A et al. FP-CIT SPECT does not predict the progression of motor symptoms in Parkinson's disease. Eur Neurol 2011; 65(4):187-92.
  28. Jakobson Mo S, Linder J, Forsgren L, et al. Accuracy of visual assessment of dopamine transporter imaging in early parkinsonism. Movement Disorders Clinical Practice. 2015; 2(1):17-23.
  29. Kagi G, Bhatia KP, Tolosa E. The role of DAT-SPECT in movement disorders. J Neurol Neurosurg Psychiatry 2010; 81(1):5-12.
  30. Kemp PM, Clyde K, Holmes C. Impact of dopamine transporter SPECT using 123I-Ioflupane on the diagnosis and management of patients with dementia with Lewy bodies: a retrospective study. Nucl Med Commun 2011; 32(4):298-302.
  31. Kupsch A, Bajaj N, Weiland F et al. Changes in Clinical Management and Diagnosis following DaTscan SPECT Imaging in Patients with Clinically Uncertain Parkinsonian Syndromes: A 12-Week Follow-Up Study. Neurodegener Dis 2013; 11(1):22-32.
  32. Kupsch AR, Bajaj N, Weiland F et al. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry 2012; 83(6):620-8.
  33. Levine CB, Fahrbach KR, Siderowf AD, et al. Diagnosis and Treatment of Parkinson’s Disease: A Systematic Review of the Literature (Evidence Report/Technology Assessment No. 57). Rockville, MD: Agency for Healthcare Research and Quality; 2003 June.
  34. Marshall VL, Reininger CB, Marquardt M et al. Parkinson's disease is overdiagnosed clinically at baseline in diagnostically uncertain cases: a 3-year European multicenter study with repeat [123I]FP-CIT SPECT. Mov Disord 2009; 24(4):500-8.
  35. McCleery J, Morgan S, Bradley KM, et al. Dopamine transporter imaging for the diagnosis of dementia with Lewy bodies. Cochrane Database Syste Rev. Jan 30, 2015.
  36. McKeith I, O'Brien J, Walker Z et al. Sensitivity and specificity of dopamine transporter imaging with 123I-FP-CIT SPECT in dementia with Lewy bodies: a phase III, multicentre study. Lancet Neurol 2007; 6(4):305-13.
  37. McKeith IG, Boeve BF, Dickson DW, et al. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. Jul 04 2017; 89(1):88-100. 
  38. Mo SJ, Linder J, Forsgren L, et al. Accuracy of visual assessment of dopamine transporter imaging in early parkinsonism. Mov Disord Clin Pract. 2015; 2(1):17-23.
  39. Moonis G, Subramaniam RM, Trofimova A, et al. ACR Appropriateness Criteria Dementia. Available at https://acsearch.acr.org/docs/3111292/Narrative/. American College of Radiology. Accessed September 17, 2020.
  40. National Institute for Health and Care Excellence (NICE). Dementia: assessment, management and support for people living with dementia and their careers [NG97]. 2018; https://www.nice.org.uk/guidance/ng97. Accessed July 31, 2019.
  41. National Institute for Health and Care Excellence (NICE). Parkinson’s disease in adults [NG71]. 2017; www.nice.org.uk/guidance/NG71. Accessed July 31, 2019.
  42. National Institute for Health and Care Excellence (NICE). Dementia: supporting people with dementia and their careers in health and social care [CG42]. 2016; www.nice.org.uk/guidance/CG42/chapter/1-Guidance#diagnosis-and-assessment-of-dementia. Accessed May 10, 2018.
  43. National Institute for Health and Care Excellence (NICE). Parkinson's disease in over 20s: diagnosis and management [CG35]. 2006; www.nice.org.uk/guidance/cg35#diagnosing-parkinsons-disease. Accessed July 31, 2019.
  44. National Institute for Health and Clinical Excellence (NICE). Parkinson's disease (update). 2016; www.nice.org.uk/guidance/indevelopment/GID-CGWAVE0698. Accessed August 23, 2016.
  45. Nicastro N, Garibotto V, Allali G, et al. Added value of combined semi-quantitative and visual [123I]FP-CIT SPECT Analyses for the diagnosis of dementia with Lewy bodies. Clin Nucl Med. Feb 2017; 42(2):e96-e102.
  46. Nicastro N, Garibotto V, Badoud S, et al. Scan without evidence of dopaminergic deficit: A 10-year retrospective study. Parkinsonism Relat Disord. Oct 2016; 31:53-58.
  47. 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). May 2017; 96(21):e6967.
  48. O'Brien JT, Oertel WH, McKeith IG, et al. Is ioflupane I123 injection diagnostically effective in patients with movement disorders and dementia? Pooled analysis of four clinical trials. BMJ Open. 2014; 4(7):e005122.
  49. Oravivattanakul S, Benchaya L, Wu G, et al. Dopamine transporter (DaT) scan utilization in a movement disorder center. Mov Disord Clin Pract. 2015; 3(1):31-35.
  50. Papathanasiou N, Rondogianni P, Chroni P et al. Interobserver variability, and visual and quantitative parameters of (123) I-FP-CIT SPECT (DaTSCAN) studies. Ann Nucl Med 2012; 26(3):234-40.
  51. Papathanasiou ND, Boutsiadis A, Dickson J et al. Diagnostic accuracy of (1) (2) (3) I-FP-CIT (DaTSCAN) in dementia with Lewy bodies: a meta-analysis of published studies. Parkinsonism Relat Disord 2012; 18(3):225-9.
  52. Postuma RB, Berg D, Stern M, et al. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. Oct 2015; 30(12):1591-1601.
  53. Prashanth R, Roy SD, Mandal PK, et al. High-accuracy classification of parkinson's disease through shape analysis and surface fitting in 123I-Ioflupane SPECT imaging. IEEE J Biomed Health Inform. May 2017; 21(3):794-802.
  54. Rizzo G, Copetti M, Arcuti S, et al. Accuracy of clinical diagnosis of Parkinson disease: A systematic review and meta-analysis. Neurology. Feb 09 2016; 86(6):566-576.
  55. Rogers G, Davies D, Pink J, et al. Parkinson's disease: summary of updated NICE guidance. BMJ. Jul 27 2017; 358:j1951.
  56. Sadasivan S, Friedman JH. Experience with DaTscan at a tertiary referral center. Parkinsonism Relat Disord. Jan 2015; 21(1):42-45.
  57. Scherfler C, Schwarz J, Antonini A et al. Role of DAT-SPECT in the diagnostic work up of parkinsonism. Mov Disord 2007; 22(9):1229-38.
  58. Seibyl JP, Kupsch A, Booij J, et al. Individual-Reader Diagnostic Performance and Between-Reader Agreement in Assessment of Subjects with Parkinsonian Syndrome or Dementia Using 123I-Ioflupane Injection (DaTscan) Imaging. J Nucl Med. Aug 2014; 55(8):1288-1296.
  59. Seifert KD, Wiener JI. The impact of DaTscan on the diagnosis and management of movement disorders: A retrospective study. Am J Neurodegener Dis. 2013; 2(1):29-34.
  60. Shimizu S, Namioka N, Hirose D, et al. Comparison of diagnostic utility of semi-quantitative analysis for DAT-SPECT for distinguishing DLB from AD. J Neurol Sci. Jun 15 2017; 377:50-54.
  61. Siepel FJ, Rongave A, Buter TC et al.  (123I)FP-CIT SPECT in suspected dementia with Lewy bodies: a longitudinal case study.  BMJ Open 2013; 3(4).
  62. Sixel-Doring F, Liepe K, Mollenhauer B et al. The role of 123I-FP-CIT-SPECT in the differential diagnosis of Parkinson and tremor syndromes: a critical assessment of 125 cases. J Neurol 2011; 258(12):2147-54.
  63. Skanjeti A, Castellano G, Elia BO, et al. Multicenter semiquantitative evaluation of (123)I-FP-CIT brain SPECT. J Neuroimaging. Nov-Dec 2015; 25(6):1023-1029.
  64. 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; 66(7):968-75. [Practice Guideline]. 2006/04/12. Available online at: www.neurology.org/content/66/7/968.full.pdf.
  65. Thiriez C, Itti E, Fenelon G, et al. Clinical routine use of dopamine transporter imaging in 516 consecutive patients. J Neurol. Apr 2015; 262(4):909-915.
  66. Thomas AJ, Attems J, Colloby SJ, et al. Autopsy validation of 123I-FP-CIT dopaminergic neuroimaging for the diagnosis of DLB. Neurology. Jan 17 2017; 88(3):276-283.
  67. Tolosa E, Borght TV, Moreno E. Accuracy of DaTSCAN (123I-Ioflupane) SPECT in diagnosis of patients with clinically uncertain parkinsonism: 2-year follow-up of an open-label study. Mov Disord 2007; 22(16):2346-51.
  68. Tu XJ, Hwang WJ, Ma HI, et al. Determinants of generic and specific health-related quality of life in patients with Parkinson's disease. PLoS One. 2017; 12(6):e0178896.
  69. Ueda J, Yoshimura H, Shimizu K, et al. Combined visual and semi-quantitative assessment of 123I-FP-CIT SPECT for the diagnosis of dopaminergic neurodegenerative diseases. Neurol Sci. Jul 2017; 38(7):1187-1191.
  70. van der Zande JJ, Booij J, Scheltens P, et al. [(123)] FP-CIT SPECT scans initially rated as normal became abnormal over time in patients with probable dementia with Lewy bodies. Eur J Nucl Med Mol Imaging. Jun 2016; 43(6):1060-1066.
  71. Vlaar AM, de Nijs T, Kessels AG et al. Diagnostic value of 123I-ioflupane and 123I-iodobenzamide SPECT scans in 248 patients with parkinsonian syndromes. Eur Neurol 2008; 59(5):258-66.
  72. Vlaar AM, van Kroonenburgh MJ, Kessels AG et al. Meta-analysis of the literature on diagnostic accuracy of SPECT in parkinsonian syndromes. BMC Neurol 2007; 7:27.
  73. Vogt T, Kramer K, Gartenschlaeger M et al. Estimation of further disease progression of Parkinson's disease by dopamine transporter scan vs clinical rating. Parkinsonism Relat Disord 2011; 17(6):459-63.
  74. Walker RW, Walker Z. Dopamine transporter single photon emission computerized tomography in the diagnosis of dementia with Lewy bodies. Mov Disord. 2009; 24 Suppl 2: S754-9.
  75. 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. Br J Psychiatry. Feb 2015; 206(2):145-152.
  76. Walker Z, Moreno E, Thomas A, et al. Evolution of clinical features in possible DLB depending on FP-CIT SPECT result. Neurology. Sep 06 2016; 87(10):1045-1051.
  77. Wippold FJ, 2nd, Brown DC, Broderick DF, et al. ACR Appropriateness Criteria Dementia and Movement Disorders. J Am Coll Radiol. Jan 2015; 12(1):19-28.

POLICY HISTORY:

Medical Policy Panel, August 2012

Medical Policy Group, August 2012 (2); New Policy

Medical Policy Administration Committee, September 2012

Available for comment September 18 through November 1, 2012

Medical Policy Panel, July 2013

Medical Policy Group, July 2013 (2):  2013 Updates to Key Points and References; no change in policy statement

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3):  2014 Updates to Key Points & References; no change in policy statement

Medical Policy Panel, November 2015

Medical Policy Panel, November 2015 (3): 2015 Updates to Description, Policy Statement, Key Points and References; no change to policy intent.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (3): 2016 Updates to Description, Key Point & References. No change to policy statement.

Medical Policy Panel, October 2017

Medical Policy Group, November 2017 (3): 2017 Updates to Description, Key Points & References; No change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (3): Updates to Description, Key Points, Practice Guidelines and Position Statements and References. No changes to policy statement or intent.

Medical Policy Panel, September 2019

Medical Policy Group, October 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

Medical Policy Group, December 2019: 2020 Annual Coding Update. Added CPT Code 78803 to Current Coding Section. Created Previous Coding section to include code 78607.

Medical Policy Group, October 2020 (2): Updates to  Key Points; Policy Statement updated to allow coverage of dopamine transporter imaging with single photon emission computed tomography when used for individuals with clinically uncertain Parkinson disease or clinically uncertain dementia with Lewy bodies; considered investigational for all other indications; (effective 10/9/2020).

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (2): Updates to Key Points and References; No change to policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.