Visante 
Advancements in cancer therapy continue to emerge and among those options are radiopharmaceuticals. Radiation therapy has been around for centuries, but radiopharmaceuticals are relatively new, with iodine-131 being the first radiopharmaceutical to be approved by the FDA in 1951. Today, there are several new therapeutic radiolabeled compounds and isotopes that are causing organizations to pause to ensure charge capture and billing is appropriately addressed due to the increase in usage and cost of these agents.
CMS addresses radiopharmaceuticals alongside other drugs and biologicals. Medicare Claims Processing Manual 90.2 directs hospitals to report charges for all drugs, biologicals and radiopharmaceuticals along with the correct HCPCS and billed units that were used in the care of the patient regardless of whether the service is packaged or paid separately. In 2008, the I/OCE required claims with a separately payable nuclear medicine procedure to include a radiolabeled product on the same claim.
Similar to drugs and biologicals, radiopharmaceuticals are also eligible for transitional pass-through payment for at least 2 years but no more than 3 years. However, radiopharmaceuticals are further classified into two categories: diagnostic and therapeutic. Diagnostic radiopharmaceuticals that no longer receive pass-through status will become policy packaged into the nuclear medicine procedure. Therapeutic radiopharmaceuticals may continue to receive a separate payment or packaged based on a calculated per day cost.
As we referenced in our previous newsletter, NDC requirements are becoming more stringent by the payers and increasingly difficult to manage. Several payers, including state Medicaid programs, have extended this requirement for radiopharmaceuticals. Lastly, it is important to call out that C9399 may only be used to bill new FDA approved therapeutic radiopharmaceuticals and not for those intended for diagnostic purposes.
SHOUT-OUTS! CDM and/or IT teams to ensure radiopharmaceuticals are built in the EMR that allow the capture of the NDC, detailed HCPCS and apply the respective multiplier whether that is per millicurie or other dosing unit, or per study multiplier.
Nuclear medicine or front end operations ensure processes are established that allow the capture of the radiopharmaceutical along with the nuclear medicine procedure. Validate the process charges for the amount that was used in the care of the patient.
Billing teams ensure that claims are reporting NDC when applicable based on payer.
