Very Brief Blog: Some Data on LCDs and Review TImes (Noridian Case Study)

From time to time I review the profiles of current and proposed LCDs at a MAC, including times for LCD review.   Here is some data pulled on June 30, 2018, from the CMS database for the Noridian MAC.

Summary

• Half of Noridian LCDs are in diagnostics (2% of the Medicare budget)
• Recent records show that MACs review public comments for 2-11 months before finalizing LCDs.
• Some LCDs linger in limbo after public comments close (up to 2 years)

Half of Noridian LCDs = Lab Industry
I tallied 77 active LCDs (several of which appear to be duplicates).  28 were MolDx LCDs and 9 others were non-MolDx lab industry LCDs.  Thus, 37 lab industry LCDs out of 77 active LCDs.

Interesting to note that lab tests altogether are only about 2% of CMS spending, making them much overrepresented as 50% of LCDs.

Public Comment Review Duration: 2.4-11.5 Months
13 LCDs had "draft" versions online, with a closure date, which is the released-to-final date. 

7 were MolDx LCDs, with a review-of-comments time of 2.4 to 7.3 months, most 4.1 months.  3 non-MolDx LCDs had review time of 4.9 to 11.5 months.

Fastest Review on Record
The 2.4 month LCD was the CareDx Allosure test, a donor derived cell free DNA test for renal transplant rejection.  It went to public comment on June 1, 2017, comments closed on August 14, and the final LCD was released on October 25 (2.4 months).   

To calculate the full time from release of draft LCD to final active LCD, add 3 months.  This allows 45 days for initial public comment, the MAC comment review time (here, 2.4 months) and then 45 days which is a "notification period" before the final LCD is active.

"LCD Not Released to Final" Status: Limbo!

The spreadsheet also showed 25 LCDs in "not released to final" or NRTF status after the comment period closed.   These durations of "limbo" LCDs ranged from 78 to 691 days (average 292 days).

Days Under Review (Shown, >100 days)

13 of these were MolDx LCDs.  For example, LCDs on 4KScore assay (DL37122) and VectraDA (DL37092) have been in limbo for 446 days.   Also limbo for 446 days for 3 LCDs on comprehensive genomic profiling for melanoma, colon, and ovarian cancer, which may have been derailed by the CMS NCD on NGS testing in cancer last fall. 

Two LCDs have been in limbo for 320 days, related to pathogen gene panel tests in GI and respiratory illness (DL37368, DL37315).   The 4KScore, Vectra, GI, and Respiratory LCDs are all negative proposed LCDs. 

MACs can drop LCDs from review (they should disappear from this spreadsheet) or leave them under review indefinitely. 

MolDx LCDs may require additional time because MolDx presents them at four MACs - CGS, Palmetto, Noridian, WPS.  These have staggered public comment intervals (sometimes months apart) and MolDx may wait for the last public comment at the last MAC to close, before finalizing all comments into one LCD.

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It is not fancy-pants Excel but I've left a copy of my worksheet in the cloud here.