Local Coverage Article Response to Comments

Response to Comments: Reflectance Confocal Microscopy

A55784

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Article ID
A55784
Article Title
Response to Comments: Reflectance Confocal Microscopy
Article Type
Response to Comments
Original Effective Date
12/07/2017
Retirement Date
N/A
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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

NumberCommentResponse
1

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.

2

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.

3

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.

4

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.

5

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.

6

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

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