CMS has announced a significant update to the Hospital Outpatient Prospective Payment System (HOPPS), allowing separate reimbursement for high-cost diagnostic radiopharmaceuticals used in PET scans and other advanced molecular imaging exams.

Under the new policy, CMS will unbundle radiopharmaceuticals costing more than $630 per day, providing hospitals with separate payments for these essential diagnostic tools and aiming to improve patient access to advanced imaging.

Previously, these radiopharmaceuticals were categorized as bundled “supplies,” limiting reimbursement and creating financial obstacles for hospitals, physicians, and patients. This bundling approach often left providers with inadequate funds to cover the costs of high-value nuclear medicine scans, which are crucial for diagnosing complex diseases. The lack of coverage deterred some hospitals from offering certain nuclear imaging procedures and discouraged physicians from recommending them, while patients faced limited access to potentially lifesaving diagnostic options.

“This decision is a critical victory for patients who need advanced diagnostic care,” said Cathy Sue Cutler, president of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), which has long advocated for more equitable reimbursement. “We commend CMS for this significant move to improve access to lifesaving nuclear medicine scans, ensuring that patients across the country can receive the best possible care.”

SNMMI’s advocacy efforts over the past 16 years contributed to this policy shift. The organization has submitted numerous letters to CMS, coordinated meetings with congressional leaders, organized grassroots campaigns, and called for separate reimbursement to address the financial challenges providers face in offering nuclear medicine scans.

In August 2024, SNMMI formally recommended separate payments for radiopharmaceuticals at both $630 and $550 thresholds, reinforcing the urgency for change. The new policy, set to take effect on January 1, 2025, is anticipated to alleviate financial strains and support the continued development of innovative diagnostic agents.

The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), also expressed support for the change.

“MITA applauds the CMS decision that will increase access to diagnostic radiopharmaceutical drugs that are essential to provide patients with accurate diagnoses and access to a number of therapies," said Sue Bunning, MITA's managing director of PET. "MITA appreciates the time and attention given by CMS to this issue, and we look forward to working with the agency on its implementation. This decision has the ability to change lives.”

The policy change removes the need for legislative action under the FIND Act, for which SNMMI members and supporters had strongly advocated in recent years.

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