CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins during Breast-Conserving Surgery

Policy governs coverage and medical necessity determinations for use of handheld radiofrequency spectroscopy devices (eg, MarginProbe) to assess lumpectomy surgical margins intraoperatively for patients undergoing breast-conserving surgery; applies to Medicare Advantage and commercial products through Blue Cross Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyHandheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins during Breast-Conserving Surgery

Policy CodePolicy N/A

Change TypeNo material change

Effective Date07|01|2023

Next Review DateN/A

Key ActionVerify member eligibility and benefits with the payer prior to performing the procedure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0546THCPCS/CPT code identified as not covered / not medically necessary

Not coveredCoverage stance for Medicare Advantage Plans

Not medically necessaryCoverage stance for Commercial Products

95%/85%Device sensitivity/specificity mentioned

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Coverage Determinations

Coverage stances

Medicare Advantage Coverage Stance: Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery is not covered because the evidence is insufficient to determine that the technology results in an improvement in net health outcome.

Commercial Products Coverage Stance: Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery is not medically necessary because the evidence is insufficient to determine that the technology results in an improvement in net health outcome.

The procedure code 0546T (Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report) is listed in this policy as not covered / not medically necessary for the products specified. Claims billed with 0546T are subject to denial or nonpayment in accordance with the coverage stance.

For Commercial Products, handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins (CPT/HCPCS 0546T) is considered not medically necessary because the evidence is insufficient to demonstrate an improvement in net health outcome.

CPT/HCPCS Coding

Not covered / Not medically necessaryCPTNot Covered

0546T

Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report

Provider Billing and Action Items

Prior Authorization

Prior authorization is not required for this service.

Prior Authorization: Not applicable

Step Therapy

No step therapy requirements are specified for this service.

Documentation Required

Benefit Verification Required

Benefit Booklet/Evidence of Coverage/Subscriber Agreement determine member-specific benefit limits and coverage. Verify member benefits and eligibility prior to rendering services.

Background and Clinical Context

Breast-conserving surgery aims to achieve tumor-free margins to reduce the need for re-excision. The MarginProbe device is a handheld radiofrequency spectroscopy probe intended to assess the dielectric properties of the lumpectomy specimen intraoperatively and provide touch-based positive/negative readings; a positive reading on any touch classifies that margin as positive. Definitive determination of margin status remains histologic examination of excised tissue, and intraoperative adjuncts vary in accuracy and resource requirements.

Device Definitions and Intended Use

MarginProbe / handheld radiofrequency spectroscopy — device description

Device name and technologyMarginProbe — an intraoperative handheld probe that uses radiofrequency spectroscopy to measure dielectric properties of tissue on the lumpectomy specimen.

How it samples tissueA handheld probe is applied to small areas of the main lumpectomy specimen; each contact ('touch') is analyzed separately.

Result reportingProvides a positive or negative reading for each touch; a positive reading on any touch classifies that margin as positive.

Clinical interpretationIf a margin is classified as positive, additional tissue should be re-excised if possible to achieve clear margins.

Intended effectIntended to increase the probability of achieving clear margins during the initial surgery and reduce the need for re-excision.