CMS adjusts reimbursement for diagnostic radiopharmaceuticals

The Centers for Medicare & Medicaid Services (CMS) has announced an adjustment under the CY 2025 Hospital Outpatient Prospective Payment System (HOPPS) Final Rule in which CMS will now unbundle and pay separately for diagnostic radiopharmaceuticals with per-day costs exceeding $630.¹

Under the new policy, CMS will now pay separately for these scans.

The decision applies to any specialized diagnostic radiopharmaceutical for Medicare Fee for Service patients in the hospital outpatient setting without pass-through status and with a threshold per-day cost exceeding $630. This is a significant change from the current reimbursement system, which bundled diagnostic radiopharmaceuticals as “supplies,” limiting their access for patients, physicians, and hospital systems, according to a news release from the Society of Nuclear Medicine and Molecular Imaging (SNMMI).¹

Under the new policy, CMS will now pay separately for these scans. Separate payments under HOPPS will be based on mean unit cost (MUC) derived from hospital claims data.² The rule will allow for relatively stable reimbursement beyond the traditional expiry of pass-through status at up to 3 years.

The revised policy will take effect on January 1, 2025.

“This decision is a critical victory for patients who need advanced diagnostic care,” said SNMMI president Cathy Sue Cutler, PhD, in the news release.¹ “We commend CMS for this significant move to improve access to life-saving nuclear medicine scans, ensuring that patients across the country can receive the best possible care.”

The decision comes after the SNMMI submitted formal comments to CMS in August 2024 advocating for separate payments for diagnostic radiopharmaceuticals at the thresholds of $630 and $550. In the news release, SNMMI noted that these efforts have been ongoing within the organization for the past 16 years.

According to the group, “This success also effectively removes the need for legislative action under the FIND Act, for which SNMMI members and supporters had strongly advocated in recent years.”

“This win is truly a community achievement,” Cutler added in the news release.¹ “We are deeply grateful to SNMMI members, patients, health care providers, and community advocates who joined us in supporting this important cause. Your voices made a difference.”

Several radiopharmaceutical companies have also commended the CMS decision, noting that the change may increase sustained, equitable access to advanced imaging agents for patients and physicians.^2,3,4

SNMMI said it plans to continue to work closely with CMS to refine and enhance reimbursement models to ensure equitable access for all patients.

Reference

1. In major win for patients, CMS adjusts nuclear medicine reimbursement policy, expanding access to life-saving scans. News release. The Society of Nuclear Medicine and Molecular Imaging (SNMMI). November 1, 2024. Accessed November 5, 2024. https://snmmi.org/Web/News/Articles/CMS-Adjusts-Nuclear-Medicine-Reimbursement-Policy--Expanding-Access-to-Life-Saving-Scans

2. Telix welcomes CMS decision to improve payments for diagnostic radiopharmaceuticals. News release. Telix Pharmaceuticals. November 3, 2024. Accessed November 5, 2024. https://telixpharma.com/news-views/telix-welcomes-cms-decision-to-improve-payments-for-diagnostic-radiopharmaceuticals/

3. Blue Earth Diagnostics, a Bracco Company, applauds new CMS rule to support patient access through improved payment for specialized diagnostic radiopharmaceuticals. News release. Blue Earth Diagnostics. November 4, 2024. Accessed November 5, 2024. https://4078578.fs1.hubspotusercontent-na1.net/hubfs/4078578/News/Blue%20Earth%20Diagnostics/BED%20applauds%20CMS%20rule%20press%20release%20Final%20for%20Nov%204%202024.pdf

4. CMS final rule on radio-diagnostic reimbursement policy, expanding patient access to products. News release. Clarity Pharmaceuticals. Published online and accessed November 5, 2024. https://www.claritypharmaceuticals.com/news/cms/