SNMMI SmartBrief

New year, new reimbursement for Ioflupane I 123 Injection. What you should know.

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SmartBrief on Nuclear Medicine and MI Professionals

What does this mean for your
patients on Medicare?

Like you, we celebrate steps toward greater product accessibility that enable patients to obtain the scans they need so their healthcare team can make more informed treatment decisions. That's why we are excited to announce that the CMS pricing landscape for 2025 has changed.¹

According to the final CMS ruling, as of January 1, 2025, the reimbursable amount for Medicare patients in an outpatient hospital setting was revised to ~$2600.^1-3*

CMS reimbursement rates for the radiopharmaceutical and procedure are as follows:

	Ioflupane I 123 Injection (radiopharmaceutical): $1388.02²
	Procedure: $1305.48³

This change only impacts Medicare patients in an outpatient setting.

What should you keep in mind?

	The radiopharmaceutical and procedure are now separately reimbursed¹
	This change only applies for patients covered by Medicare and within an outpatient hospital setting whose nuclear medicine diagnostic scan cost is over a certain threshold (Ioflupane I 123 Injection meets this threshold)¹
	New process: Facilities are required to complete an extra coding step on the CMS-1450 form that entails adding separate and correct codes for the radiopharmaceutical and procedure: HCPCS code A9584 for Ioflupane I 123 Injection (radiopharmaceutical) CPT codes 78803 or 78830 for the procedure

Enter HCPCS code A9584 for Ioflupane I 123 Injection (radiopharmaceutical)
Enter CPT codes 78803 or 78830 for the procedure
Enter the same date for the procedure and radiopharmaceutical
Enter a 1 in the Service Units column

For more details, visit the CMS website.

Learn More

Ioflupane I 123 Injection is available 5 days a week

Count on 7 AM deliveries Monday through Friday to most locations in the US. To place an order, call Curium customer service at 888-744-1414.

INDICATION AND USE
Ioflupane I 123 is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:

suspected Parkinsonian syndromes (PS) or
suspected dementia with Lewy bodies (DLB).

Important Risk Information

CONTRAINDICATIONS
Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to ioflupane I 123.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration.

Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of I-123, block the thyroid gland before administration of Ioflupane I 123 Injection.

Radiation Risk: Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.

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 Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established.

USE IN SPECIFIC POPULATIONS
Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection.

Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant.

Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients.

Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies.

Renal Impairment: Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images.

OVERDOSAGE
The risks of overdose relate predominantly to increased radiation exposure, with the long-term risk for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.

Prior to Ioflupane I 123 Injection administration, please read the full Prescribing Information for additional Important Risk Information.

References: 1. Federal Register. Medicare and Medicaid programs: hospital outpatient prospective payment and ambulatory surgical center payment systems; quality reporting programs, including the hospital inpatient quality reporting program; health and safety standards for obstetrical services in hospitals and critical access hospitals; prior authorization; requests for information; Medicaid and CHIP continuous eligibility; Medicaid clinic services four walls exceptions; individuals currently or formerly in custody of penal authorities; revision to Medicare special enrollment period for formerly incarcerated individuals; and all-inclusive rate add-on payment for high-cost drugs provided by Indian health service and tribal facilities. Accessed January 16, 2025. https://www.federalregister.gov/documents/2024/11/27/2024-25521/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical 2. Centers for Medicare & Medicaid Services. January 2025 Addendum A. Accessed February 3, 2025. https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient-pps/quarterly-addenda-updates/january-2025-addendum 3. Centers for Medicare & Medicaid Services. January 2025 Addendum B. Accessed February 3, 2025. https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient-pps/quarterly-addenda-updates/january-2025-addendum-b

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