10/05/2025
FDA Approves ProSense Cryoprobe for Breast Cancer Cryoablation
By now, many of you have heard that the FDA has approved the use of the ProSense (IceCure) cryoprobe for the treatment of breast cancer with cryoablation. This approval applies specifically to women aged 70 years and older with low-risk, hormone-sensitive, HER2/neu-negative invasive ductal carcinoma measuring 1.5 cm or less.
While this represents a major milestone, it is only the beginning of the process of achieving full Medicare and commercial insurance coverage for breast cancer cryoablation. Here’s what you need to know about the FDA approval and what comes next:
1. Post-Market Study Requirement
The FDA approval is contingent upon IceCure conducting a post-market study of 400 additional patients to gather more data on the safety and effectiveness of cryoablation in the approved patient population. This study is expected to begin next year and take 2–3 years to complete. I will be participating in this study.
2. Current Medicare Coverage
In the meantime, Medicare will continue to reimburse the “technical” cost (approximately $3,800 of Billing CPT Code 0581T) for breast cryoablation procedures performed in hospitals and hospital-owned clinics.
This coverage:
• Does not yet apply to cryoablation performed in outpatient clinics or private offices.
• Covers only the hospital cost for cryoablation equipment and supplies.
• Does not cover the physician’s professional fee for the procedure.
As a result, many hospitals or cryoablation providers might still find it financially challenging to offer cryoablation without separate payment for professional services. Furthermore, this is a Medicare-only payment decision; other insurers will make their own determinations regarding CPT Code 0581T.
3. Determining Professional Fees
During the post-market study period, data will be collected to estimate the average physician work-effort involved in:
• Prepping patients for cryoablation
• Performing the cryoablation procedure
• Managing patients during the first 3 months post-procedure
• Related overhead and malpractice insurance cost
These factors will be used to establish an appropriate professional fee (physician payment). This data collection process will take several years and may also result in an increase to the equipment and supply (“technical”) reimbursement.
4. Toward a Unified Billing Code
Once steps 1–3 have been completed (estimated 3–5 years), it is anticipated that a new billing CPT code will be released that includes both the professional and technical components and associated costs. This code should apply to breast cryoablation procedures performed in both hospital and office settings, and is expected to be covered by Medicare as well as commercial insurers. It is likely that the indication will remain restricted to women aged 70 years and older with low-risk, hormone-sensitive, HER2/neu-negative invasive ductal carcinoma measuring 1.5 cm or less until further studies are conducted evaluating younger patients or different types of breast cancer.
Bottom line: This FDA approval is a critical first step toward making breast cancer cryoablation widely accessible and reimbursable. Continued data collection will drive broader coverage and payment for both the technical and professional components.
Hopefully that’s all clear. If not, feel free to ask for clarification.
www.cryoablation.com
