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Radiopharmaceutical and stress agents for cardiac PET not paid separately

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Q.

For outpatient hospital billing, are the radiopharmaceutical (CardioGen-82® Rubidium Rb 82 Generator) and stress agents for cardiac PET bundled or paid separately?

A.

For Medicare billing under the Outpatient Prospective Payment System (OPPS), diagnostic radiopharmaceuticals, and stress agents are packaged unless the product has pass-through status. Currently, none of the cardiac PET radiopharmaceuticals or stress agents have pass-through status and are therefore not separately paid. Not being reimbursed does not however mean that the charges should not be submitted as charge amounts are used to refine future payment methodologies under OPPS.

Other payers may reimburse for the radiopharmaceutical and the stress agents but that would depend on each payer’s policy and the patient’s individual plan. 

CARDIOGEN-82® (Rubidium Rb 82 Generator)

Indications and Usage:

CARDIOGEN-82® (Rubidium Rb 82 Generator) is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. 

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT

AND FAILURE TO FOLLOWTHE ELUATE TESTING PROTOCOL

Please see full prescribing information for complete boxed warning

High Level Radiation Exposure with Use of Incorrect Eluent

Using the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels (5.1)

• Use only additive-free 0.9%Sodium Chloride Injection USP to elute the generator (2.5)

• Immediately stop the patient infusion and permanently discontinue the use of the affected CARDIOGEN-82 generator if the incorrect solution is used to elute the generator (4)

• Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow (2.10)

Excess Radiation Exposure with Failure to Follow the Eluate Testing ProtocolExcess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed limits. (5.2)

• Record eluate volume, including waste and test volumes. (2.5)

• Strictly adhere to the generator eluate testing protocol (2.6, 2.7)

• Stop using the generator if it reaches any of its Expiration Limits (2.8)

Please see full Prescribing Information for CARDIOGEN-82 (Rubidium Rb 82 Generator) including boxed WARNING at: https://imaging.bracco.com/sites/braccoimaging.com/files/technica_sheet_pdf/us-en-2020-11-24-spc-cardiogen-82.pdf

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CARDIOGEN-82 is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by GE Healthcare, Medi-Physics, Inc., South Plainfield, NJ 07080.

CARDIOGEN-82 is a registered trademark of Bracco Diagnostics Inc.

WE ARE CARDIAC PET is a trademark of Bracco Diagnostics Inc.

Bracco Diagnostics Inc.

259 Prospect Plains Road, Building H

Monroe Township, NJ 08831 USA 

Phone: 609-514-2200

Toll Free: 1-877-272-2269 (U.S. only)

Fax: 609-514-2446

©  Bracco Diagnostics Inc. All Rights Reserved.