DaTscan

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine.

See Product Indications and Additional Important Safety Information About DaTscan.

Please also read the Full Prescribing Information.
Visit the DaTscan brand website.

PRODUCT INDICATIONS AND USE:
DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

CONTRAINDICATONS: DaTscan is contraindicated in patients with known hypersensitivity to the active subsctance, any of the excipients, or iodine.

DaTscan Provides Visual Clarity

Visualization of striatal DaT distribution can aid in the clinical diagnosis of PS, including^1,2:

Important Risk and Safety Information About DaTscan: In clinical trials, reported adverse events consisted of headache, nausea, vertigo, dry mouth, or dizziness. These reactions were of mild to moderate severity. In postmarketing experience, hypersensitivity reactions have been reported, generally consisting of skin erythema and pruritus. Injection-site pain also has been reported. To decrease thyroid accumulation of iodine 123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may result in an increased long-term risk for thyroid neoplasia.

How It Works

Motor symptoms of parkinsonian syndromes are associated with striatal dopaminergic neuron loss^1-3,7
DaTscan binds presynaptically to striatal DaT and, when used with SPECT, may identify dopaminergic integrity^2,4,5,8
Differentiation between normal and abnormal scans is assessed by the extent (as indicated by shape) and intensity of the striatal signal following DaTscan administration and SPECT scanning^2,6,7,9

Image Interpretation

1. 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;19:1175-1182.
2. DaTscan [prescribing information]. Arlington Heights, IL: GE Healthcare; 2015.
3. Booij J, Habraken JB, Bergmans P, et al. Imaging of dopamine transporters with iodine-123-FP-CIT SPECT in healthy controls and patients with Parkinson’s disease. J Nucl Med. 1998;39:1879–1884.
4. Antonini A, Berto P, Lopatriello S, et al. Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson's disease in Italy. Mov Disord. 2008;23:2202-2209.
5. Dodel RC, Höffken H, Möller JC, et al. Dopamine transporter imaging and SPECT in diagnostic work-up of Parkinson's disease: a decision-analytic approach. Mov Disord. 2003;18:S52-S62.
6. Winogrodzka A, Bergmans P, Booij J, et al. [123I]FP-CIT SPECT is a useful method to monitor the rate of dopaminergic degeneration in early-stage Parkinson's disease.
J Neurol Transm. 2001;108:1011-1019.
7. Asanuma K, Dhawan V, Carbon M, Eidelberg D. Assessment of disease progression in parkinsonism. J Neurol. 2004;251(suppl 7):VII/4-VII/8.
8. Niznik HB et al. J Neurochem. 1991;56:192-198
9. PI and Benamer Movement Disorders. 2000;15(3):503-510.
10.PI, Benamer et al. Movement Disorders 2003;18(9):977–984.

Indications

See Important Safety Information About DaTscan at the bottom of this page.

Please also read the Full Prescribing Information.

DaTscan Indication

DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PS)
DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy)
DaTscan is an adjunct to other diagnostic evaluations. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established

Contraindications: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine.

Reimbursement

See Additional Important Safety Information About DaTscan at the bottom of this page.

Please also read the Full Prescribing Information.

Reimbursement for DaTscan^TM(Ioflupane I 123 Injection)

Contraindications: DaTscan is contraindicated in patients with known hypersensitivity to the active subsctance, any of the excipients, or iodine.

Suggested Coding and Payment Information

In order to receive appropriate reimbursement, physicians should report the appropriate HCPCS code for the product along with the appropriate CPT^® code(s) for the procedure(s). Some payers may require the National Drug Code (NDC) for DaTscan: 17156-210-01.

Medicare Claims

The Centers for Medicare & Medicaid Services (CMS) assigned DaTscan product HCPCS code A9584. Medicare reimbursement is different depending on whether the site of service is a hospital outpatient department or freestanding facility/physician office.

Medicare - Hospital Outpatient Departments 2013 Reimbursement for DaTscan™ (Ioflupane I 123 Injection)

DaTscan has its own Ambulatory Payment Classification (APC), APC 9406. Hospital Outpatient Departments (HOPDs) should report APC 9406 with the appropriate HCPCS code, A9584. HOPDs should also report APC 0402, Level II Nervous System Imaging, with the appropriate CPT^® code, 78607, Brain imaging, tomographic (SPECT).²

Important Risk and Safety Information About DaTscan

CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. Please read full prescribing information for DaTscan before use.

Please see Full Prescribing Information.

Codes and Description - Medicare Hospital Outpatient Department Payment

Codes	Description	Medicare Hospital Outpatient Payment	Patient Coinsurance²
HCPCS: A9584 with APC: 9406	Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 millicuries	$1,990.082 - $187.693 = $1,802.39 (ASP+6% - Offset Amount)	$0
AND
CPT®: 78607 with APC: 0402	Brain imaging, tomographic (SPECT)	$458.34² (includes $187.69 for DaTscan)	$91.67

Please note that CMS granted DaTscan Pass-Through Status in the Hospital Outpatient Prospective Payment System effective July 1, 2011. As a result, CMS pays Average Sales Price (ASP) + 6% for DaTscan separately from the imaging payment. CMS updates the ASP quarterly.

In 2013, a payment offset policy reduces the separate payment for DaTscan by $187.69.³ The offset accounts for the portion of the radiopharmaceutical payment included in APC 0402. Therefore, HOPDs must report both APC 0402 and APC 9406 to receive full payment for DaTscan and the imaging procedure.

Codes and Description - Medicare Freestanding Facility/Physician Office Payment

Payment to a free-standing facility/physician office is made through two separate payments, one for the SPECT imaging service and the other for DaTscan drug. Unlike the case with most drugs and biologics, Medicare Administrative Contractors (MACs) set payment limits for radiopharmaceuticals. For example, [Wisconsin Physician Services], the MAC for [Wisconsin], set a 2013 payment rate of [$2,257.20] for DaTscan product.

Codes	Description	Freestanding Facility Payment	Patient Coinsurance
HCPCS: A9584	Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 millicuries	The lesser of invoice or 95% of AWP	20%
AND
CPT®: 78607	Brain imaging, tomographic (SPECT)	Technical $305.87⁴ Professional $56.14⁴ Global $362.00⁴	20%

Non-Medicare Claims for All Sites of Services

Medicaid programs and private payers may require different codes. Private payers will likely require preauthorization for the procedure; the patient's physician must establish the medical necessity for the procedure. The private payment will base payment for DaTscan and the procedure upon the terms of your facility's contractual agreement.

GE Healthcare Reimbursement Hotline	GE Healthcare Web Site
GE Healthcare is pleased to offer toll-free customer support and documentation for coding and reimbursement related to GE Healthcare products. Please contact our Reimbursement Hotline at: 800 767 6664	For more information regarding coding and reimbursement related to other GE Healthcare products, please visit our web site at: gehealthcare.com

The information referenced and provided is based upon coding experience and research of current general coding practices. The existence of codes does not guarantee coverage or payment for any procedure or contrast agent by any payer. The final decision for coding of any procedure must be made by the provider of care after considering the medical necessity of the services and supplies provided as well as the regulations and local, state, or federal laws that may apply. The coding and payment data are furnished for general informational purposes only and should not be relied upon for purposes of determining payer coverage and coding for a specific case or claim for payment. Providers should refer to authoritative coding sources, such as the Common Procedural Terminology (CPT®) codes and Healthcare Common Procedure Coding System (HCPCS) codes.

1. DaTscan (Ioflupane I 123 Injection) Prescribing Information 2015. GE Healthcare.
2. April 2013 Addendum B Hospital Outpatient Prospective Payment System.
3. 2013 OPPS Payment Offset File.
4. Medicare adjusts payments by locality. These payment amounts reflect Medicare's an estimated national payment for CPT® 78607 in its Physician Fee Schedule Search located at https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx. There is no actual national payment and your payment may differ from this calculation depending on your locality.

How Supplied

See Important Safety Information About DaTscan at the bottom of this page.

Please also read the Full Prescribing Information.

How DaTscan (Ioflupane I 123 Injection) Is Supplied¹

DaTscan is supplied in 10-mL glass vials
Each vial contains a total volume of 2.5 mL of solution with a total radioactivity of 185 MBq (5 mCi) at calibration time
Each vial is enclosed in a lead container of appropriate thickness

Storage

Once received, DaTscan must be stored in its original lead container (or an equivalent radiation shielding) at 68°-77°F (20°-25°C), substantially constructed cabinet.¹ Do not use DaTscan after the expiration data and time stated on the label.

1. DaTscan (Ioflupane I 123 Injection) Prescribing Information. GE Healthcare. 2015.

Professional Resources and Disclosures

See Additional Important Safety Information About DaTscan at the bottom of this page.

Please also read the Full Prescribing Information.

Please see the following for more information:

HIPAA Policy

Safe Harbor Privacy Policy

California Declaration of Compliance

Licensing and collaboration

Product Indications and Important Safety Information About DaTscan™ (Ioflupane I 123 Injection)

PRODUCT INDICATIONS AND USE: DaTscan™ (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine.

WARNINGS AND PRECAUTIONS - Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following DaTscan administration.Thyroid Accumulation: The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia.

ADVERSE REACTIONS: In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported.

DRUG INTERACTIONS: Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established.

SPECIFIC POPULATIONS - Pregnancy: It is unknown whether DaTscan can cause fetal harm or increase the risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm, depending on the stage of fetal development and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers:It is not known whether DaTscan is excreted into human milk; however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan at all. Nursing women may consider interrupting nursing and pumping and discarding breast milk for six days after DaTscan administration to minimize risks to a nursing infant. Pediatric Use: The safety and efficacy of DaTscan have not been established in pediatric patients. Geriatric Use: There were no differences in responses between the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.

OVERDOSAGE: It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.

PROCEDURE - Radiation Safety: DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.

Prior to DaTscan administration, please read the Full Prescribing Information.

JB59093US| Nov 2018