Medicare will cover NanoKnife for prostate cancer starting July 5, 2026, but only for a narrow group of patients treated in seven states. Coverage is limited to men with favorable intermediate-risk disease (Grade Group 2, Gleason 3+4) whose care is billed through Palmetto GBA, the Medicare Administrative Contractor for Alabama, Georgia, Tennessee, North Carolina, South Carolina, Virginia, and West Virginia. Everyone outside that risk group or those states remains non-covered under Medicare, and most commercial insurers still classify the procedure as experimental.1Morningstar. AngioDynamics Expands Patient Access to NanoKnife IRE for Prostate and Liver Cancer as Medicare Coverage Framework Takes Effect
Who Qualifies Under the New Policy
The coverage comes from Local Coverage Determination L40205, which Palmetto GBA finalized on May 28, 2026, with an effective date of July 5, 2026. For prostate cancer, coverage applies only to patients with favorable intermediate-risk, organ-confined disease, defined as Grade Group 2 (Gleason Score 3+4).2CMS. LCD L40205 – Irreversible Electroporation for Cancer
The patient must be “appropriately selected,” and the treating physician has to document a face-to-face discussion covering the alternatives: active surveillance, radiation therapy, and prostatectomy. The physician must also acknowledge, on the record, that high-quality long-term data on NanoKnife is lacking.
Patients with high-risk prostate cancer, Gleason 4+3 disease, or any other prostate cancer classification fall outside the policy. The LCD is otherwise a non-coverage determination.
Which States the Coverage Applies In
This is a local decision, not a national one. There is no National Coverage Determination for NanoKnife, so the policy applies only where Palmetto GBA processes Medicare claims:
- Jurisdiction J: Alabama, Georgia, Tennessee
- Jurisdiction M: North Carolina, South Carolina, Virginia, West Virginia
Treatment performed in any other state is processed by a different Medicare Administrative Contractor, and no other MAC has issued a matching coverage policy as of mid-2026.1Morningstar. AngioDynamics Expands Patient Access to NanoKnife IRE for Prostate and Liver Cancer as Medicare Coverage Framework Takes Effect If you live in a Palmetto state but travel elsewhere for the procedure, the MAC that pays the claim is the one for the treatment location, not your home state.
Medicare Advantage Is Not Bound by This Policy
If you have a Medicare Advantage plan rather than Original Medicare, the LCD does not automatically apply. Advantage plans set their own medical necessity rules. Providence Health Plan, for example, has a standing policy that classifies NanoKnife as not medically necessary, citing insufficient evidence, with no exception process beyond a pre-service organization determination.3Providence Health Plan. Medicare Medical Policy 393 Check your Evidence of Coverage or call the plan directly before scheduling.
Commercial Insurance Still Denies Most Claims
The new Medicare policy has not moved private insurers. Every major commercial plan reviewed continues to classify NanoKnife for prostate cancer as experimental, investigational, or unproven.
- Aetna considers irreversible electroporation “experimental, investigational, or unproven” for prostate cancer and specifically lists CPT 55877 as not covered.4Aetna. Clinical Policy Bulletin 0843
- UnitedHealthcare classifies the ablation as “unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.”5UnitedHealthcare. Prostate Surgeries and Interventions
- Blue Cross Blue Shield of Louisiana, BCBS of Mississippi, and the Federal Employee Program all treat it as investigational. BCBS of Mississippi updated its policy in May 2026 specifically to add prostate tumors to the investigational list.6BCBS of Mississippi. Irreversible Electroporation of Tumors
The reasons are consistent across insurers: no randomized controlled trials against established treatments, short follow-up periods, and no endorsement from major clinical guidelines outside of clinical trials.
What It Costs Without Coverage
Out-of-pocket pricing in the United States is estimated at roughly $70,000 to $100,000, according to an international medical tourism service that pegs the same procedure in Germany at about €35,300 to €38,900. Treat those numbers as rough benchmarks. Costs vary by hospital and surgeon, and no U.S. provider-specific pricing appears in the source material.
What the Coverage Decision Is Based On
The narrow scope of the policy tracks the narrow scope of the evidence. The pivotal study is the PRESERVE trial, a single-arm study of 121 patients with intermediate-risk, organ-confined prostate cancer at 17 sites. At 12 months, 80% of patients who completed follow-up biopsies showed no cancer in the treated area; 95% had a PSA drop, with the median falling from 5.8 ng/mL to 1.3 ng/mL; 96% of previously continent patients stayed continent; and 84% of men with good baseline sexual function maintained erections sufficient for intercourse.7Urology Times. Irreversible Electroporation With NanoKnife Found Safe, Effective for Prostate Tissue Ablation
Common side effects in the trial were blood in the urine (44%), erectile dysfunction (18%), painful urination (16%), and temporary urinary retention (15%). Twelve percent had a Grade 3 adverse event, though only three of those were directly tied to the procedure.
Two-year follow-up data on the 68 patients who reached that mark, presented at the American Urological Association meeting in May 2026, showed no new treatment failures, one negative biopsy, and 97% of patients still below their pre-treatment PSA baseline.8AngioDynamics. AngioDynamics Announces Two-Year PRESERVE Trial Data
Palmetto GBA, responding to public comments on the draft LCD, noted that neither the National Comprehensive Cancer Network nor the American Urological Association recommends the procedure for prostate cancer outside of clinical trials, and that FDA 510(k) clearance for “soft tissue ablation, including prostate tissue” is not the same as an approval to treat prostate cancer. Those points explain why coverage stops at Grade Group 2 rather than extending across risk categories.9CMS. Response to Comments on LCD DL40205
If Medicare Denies Your Claim
A denial is not the end of the process. Medicare has a five-level appeals path:
- Redetermination by the MAC, filed within 120 days of the denial using CMS Form 20027 or a written letter. The MAC has 60 days to respond.
- Reconsideration by a Qualified Independent Contractor.
- Hearing before the Office of Medicare Hearings and Appeals.
- Review by the Medicare Appeals Council.
- Judicial review in federal district court.
Send physician notes, test results, and supporting medical literature with the first-level filing. Historical data from 2010 to 2014 showed that roughly 40 to 50 percent of Medicare fee-for-service appeals were at least partially reversed at the first level.10Triage Cancer. What to Do When Medicare Says No – Appealing to a Medicare Administrative Contractor For questions on your specific claim, call 1-800-MEDICARE.