Local Coverage Article Response to Comments

Response to Comments: Reflectance Confocal Microscopy


Expand All | Collapse All

Contractor Information

Article Information

General Information

Article ID
Article Title
Response to Comments: Reflectance Confocal Microscopy
Article Type
Response to Comments
Original Effective Date
Retirement Date
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Article Guidance

Article Text

The following are the comment summaries and contractor responses for Novitas Solutions Draft Local Coverage Determination (LCD) Reflectance Confocal Microscopy,DL37375 which was posted for comment on May 18, 2017 and presented at the June 2017 Contractor Advisory Committee (CAC) Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments


Several comments were received requesting the removal of the fifth paragraph stating the American Academy of Dermatology Guidelines have been taken out of context and pertain to imaging such as X-rays, CT scans, and MRIs in patients with early / thin melanomas.

After review, the contractor agrees and the policy has been amended.


Several commenters requested the policy be open to reconsideration for instances where they believe Reflectance Confocal Microscopy (RCM) may be indicated for beneficiaries including “difficult to diagnose pigmented lesions of the head and neck.”

The reconsideration process is available as a mechanism to request a revision to a contractor’s finalized policy. Further information on the LCD Reconsideration Process may be found on our website at Novitas-Solutions.com.


A few commenters mentioned or submitted a copy of the Federal Drug Administration (FDA) 501(K) letter issuing substantial equivalence determination and requested coverage of RCM for evaluating skin lesions for suspected malignancies.

This contractor recognizes the 2008 FDA statement issuing substantial equivalence determination for the VivaScope® System and notes that FDA issuance of a substantial equivalence determination does not mean that the FDA has made a determination that the device complies with other requirements of the Social Security Act or any Federal statutes and regulations administered by other Federal agencies.


Several commenters expressed some concern with the across the board non-coverage stance due to potential advances in the technology which could make it a useful service. Some commenters disagreed with the policy statement that RCM is an “evolving technology” or “investigational”; the comments refute that statement and say RCM is well-established throughout the world.

After review and consideration of the literature, the Contractor’s position of non-coverage for RCM remains in place at this time.


A few commenters pointed out grammatical errors in the first sentence of the second paragraph pertaining to the word ‘diagnosis’ suggesting it should be ‘diagnose’ and in the first sentence of the fourth paragraph requesting the word ‘in’ be changed to ‘and’.

The policy has been corrected accordingly.


A few commenters asked for the history behind the creation of the policy and agreed RCM would not be a service that is or should be used for detecting skin cancers.

The history of the policy stems from CMS assigning prices for the CPT codes for RCM which had previously been contractor priced. Novitas identified RCM as an emerging technology which is currently considered investigational therefore, non-covered at this time and felt a policy was warranted to provide timely claim processing rather than processing individual claims.

Associated Documents

Related Local Coverage Documents
L37375 - (MCD Archive Site)
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
12/01/2017 12/07/2017 - N/A Currently in Effect You are here