Friday, September 24, 2021

The MolDx "Minimal Residual Disease" LCD - Will It Appear Imminently?

In July, I published a blog on the progress and publication timelines of some major MolDx LCDs (blog here.)

One of the most highly-watched is the LCD for coverage of minimal residual disease testing in cancer - policy DL38779.   It was posted on the Medicare coverage database on September 24, 2021, and CMS instructions for LCDs require they be completed "within a rolling year of the posting date."   Hopefully, the final LCD will appear any day now.

It turns out, the "one year deadline" for LCDs is not to publish them (according to a MAC) but to finish them, internally.   So for example, an LCD finished on September 15 might actually appear or be unveiled to the public on October 10 or 20.   Also, the instruction to complete "within a rolling year" is a guideline, and CMS can allow the MAC extra time upon request.  

Find the draft MRD LCD here:

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38778&ver=7&bc=0

Find the 365-day finalization rule here:

https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/pim83c13.pdf


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Nerd note.

The MolDx/Palmetto version of the draft LCD (DL38779) does not have an associated draft billing article.  However, the MolDx/Noridian version of the draft LCD (DL38814) does have a draft billing article which is (DA58454).

The draft article has just a few remarks, being:

MolDX may make available specific forms to assist with test Technical Assessments (TAs). Please follow the instructions on the MolDX website to assist with this process. If such forms are available that pertain to the test type in question, these forms are required for successful coverage determinations.

For patients with cancer, the unit of service for this type of test is 1.

For patients without cancer, testing may not be performed more than once in a month; schedules are set based on the validity established of the individual test.

Billable codes are 81445, 81450, and 81479; not 81455, because MolDx never uses 81455.