Diagnostic radiopharmaceuticals are used in nuclear medicine scans to help physicians diagnose disease, assess treatment response, and determine eligibility for treatments. This article focuses on discussing the recent changes proposed by the Center for Medicare and Medicaid Services (CMS) in reimbursements for diagnostic radiopharmaceuticals.
New disease-modifying therapies for both Alzheimer disease and prostate cancer have recently been approved for use by the Food and Drug Administration. These new theranostic approaches rely on PET scans using expensive diagnostic radiopharmaceuticals to determine treatment eligibility (1,2). In Alzheimer disease, the impact of amyloid-targeting PET on patient management increased with the recent approvals of amyloid-targeting disease-modifying therapies—that is, lecanemab (Leqembi; Eisai) and donanemab (Kisunla; Lilly), which require a positive result on baseline amyloid-targeting PET for treatment eligibility (3). In prostate cancer, the prostate-specific membrane antigen (PSMA)–targeted PET/CT scan has revolutionized prostate cancer imaging, and 3 PSMA PET/CT agents have been approved since 2020 (4,5). Besides having diagnostic purposes, PSMA PET/CT is indicated to determine eligibility for PSMA-targeted theranostics with [177Lu]Lu-PSMA-617 (Pluvicto; Novartis) or similar agents for metastatic castration-resistant prostate cancer.
Since the cost of imaging agents is generally not separately reimbursed by government or private payers, and the cost of the imaging agents often exceeds the reimbursement for the scans, patient access to both the diagnostic radiopharmaceuticals and the newly approved therapies that depend on those agents is at risk (6). To address this problem and protect access to these new therapies for Medicare beneficiaries, the CMS has recently proposed rules that will provide separate reimbursement for expensive imaging agents. Such change has also been supported by a bipartisan group of 14 U.S. senators, led by Marsha Blackburn, which sent a letter to CMS on June 20, 2024, requesting increased patient access to PET and SPECT imaging modalities. This commentary describes the background need, CMS’ proposed new rules, and some of the impact of those rules.
PSMA PET/CT illustrates the need for a change in reimbursement policy for expensive diagnostic radiopharmaceuticals. Following current regulations, CMS granted temporary reimbursement for PSMA PET/CT via transitional pass-through status under section 1833(t)(6) of the Social Security Act. However, the transitional pass-through status is limited to a maximum of 3 y; once it expires, separate reimbursement for the imaging agent ceases and the total cost to the hospital or ambulatory surgery center for PSMA PET/CT using a diagnostic radiopharmaceutical will substantially exceed the reimbursement available from Medicare. This cost creates an unsustainable financial burden for most hospitals and ambulatory surgery centers, putting patient access to the new therapies at risk. Nevertheless, despite being expensive, PET radiopharmaceuticals used as part of theranostic approaches are highly cost-effective by identifying patients who do not benefit from far more expensive therapies. For example, a [18F]DCFPyL (Pylarify; Lantheus) scan is reimbursed by the CMS at $6,615, whereas the corresponding PSMA-targeted therapeutic radiopharmaceutical [177Lu]Lu-PSMA-617 is reimbursed at $54,226 per dose, for an average of $216,904 per patient (considering that patients receive, on average, 4 doses of [177Lu]Lu-PSMA-617).
On July 10, 2024, CMS issued a proposed rule (CMS-1809-P) for calendar year 2025 Medicare payment rates for hospital outpatient and ambulatory surgical center services. One of the many topics addressed by CMS is a proposal to provide separate reimbursement for expensive diagnostic radiopharmaceuticals that are covered under the Hospital Outpatient Prospective Payment System. Under this system, hospitals report codes for services provided to beneficiaries, and these codes are assigned to groups known as Ambulatory Payment Classifications, which represent items and services that are similar in terms of clinical treatment and cost. In 2008, the Hospital Outpatient Prospective Payment System defined diagnostic radiopharmaceuticals as products that enable the provision of a diagnostic nuclear medicine scan, and reimbursements for such products were “packaged” regardless of cost (title 42 of Code of Federal Regulations, section 419.2(b)(15)). Packaged products or services are items that are associated, ancillary, or an adjunctive part of a primary procedure or service, and no separate payments are made for such items. Put simply, that means that the hospital bears the cost of the packaged imaging agent, whether the cost is relatively low or so high that it exceeds the hospital’s total reimbursement for the PET scan.
Under the calendar year 2025 proposed rule, CMS proposes establishing a drug packaging threshold ($630) for diagnostic radiopharmaceuticals. Diagnostic radiopharmaceuticals with costs below the threshold will be reimbursed as packaged, whereas for those above the threshold, unpackaged payments based on their own Ambulatory Payment Classification amounts will be received. The CMS-proposed rule for precision diagnostic radiopharmaceuticals is clear, simple, and historic, paving the way for continued patient access for current and future diagnostic radiopharmaceuticals.
It is noteworthy that the CMS’s proposed rule and price restructuring issued on July 10, 2024, is not a guarantee, particularly since the proposed rule runs contrary to current drug pricing political scrutiny. The final rule was expected to be issued in early November 2024 after a 60-d comment period through September 9, 2024.
DISCLOSURE
No potential conflict of interest relevant to this article was reported.
Footnotes
Published online Oct. 10, 2024.
- © 2025 by the Society of Nuclear Medicine and Molecular Imaging.
- Received for publication August 14, 2024.
- Accepted for publication September 18, 2024.