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)

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.

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.

Indications

Reimbursement

How Supplied

Professional Resources and Disclosures

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