In a joint letter to the Centers for Medicaid & Medicare Services (CMS), the American College of Radiology (ACR), the Radiology Business Management Association (RBMA), RadNet and Rayus Radiology (organizations that represent outpatient radiology practices and imaging centers) are requesting CMS to waive what they contend is a burdensome and unnecessary reporting requirement when submitting claims, for separate payment, for the cost of imaging contrast agents and radiopharmaceuticals under Medicare Part B. 

The request to CMS arises from Section 90004 of the Infrastructure Investment and Jobs Act which requires manufacturers to provide a refund to CMS for the unused portions of refundable drugs administered in single-use dose containers or packages.

In response to that Act, CMS added to the CY 2023 Medicare physician fee schedule (MPFS) final rule a requirement that all claims for drugs from single-use vials or single-use packages that are reimbursable by Medicare must apply a JW modifier to identify any discarded amounts of refundable drugs or a JZ modifier to attest that there were no discarded amounts.

Ironically, that same rule from CMS contains an "imaging" exclusion for manufacturers' reporting obligations to CMS for radiopharmaceuticals and imaging agents. For purposes of reporting by manufacturers, CMS specifically excluded contrast agents from the definition of "refundable single-dose container or single-use package drug."

Nevertheless, despite the "imaging" exclusion page 69724 of the final 2023 MPFS rule states:

"Response: We agree with the commenter and clarify that even if a drug is excluded from the definition of refundable single-dose container or single-use package drug (and not subject to refunds), for example, multiple source drugs, claims for such drugs furnished from a single-dose container are still required to use the JW and JZ modifiers in accordance with the policy we are finalizing in this final rule."

Thus, for reasons entirely unclear, the JW and JZ modifiers remain a requirement for claims for contrast agents and radiopharmaceuticals used in imaging studies.

This is a complicated and perplexing rule, for sure. The stakeholders signing this letter note the confusion by many in the diagnostic imaging industry who believe that the exclusion for radiopharmaceuticals and imaging contrast agents means that complying with the JW and JZ modifiers was unnecessary. 

With the estimated more than 3 million imaging studies with contrast agents and over 1.5 million diagnostic nuclear medicine exams involving radiopharmaceuticals performed annually for Medicare Part B beneficiaries, one must hope these industry stakeholders will have success in their appeal to CMS to remove this burdensome - and unnecessary - administrative requirement.