Thursday, February 4, 2021

The 2021 Gapfill Process: Confused? Some Clues Here.

This year, 2021, CMS has assigned roughly 50 new laboratory codes (most but not all PLA codes) to the gapfill process (CMS instruction to MACs is here.)  See my August 2020 white paper on the gapfill process, here.

In this process, MACs are supposed to set proposed prices on each code by February, which CMS posts for public comment in March or April, and final MAC prices are posted around September.   However, in real life, the proposed prices have often not appeared til as late as August, triggering the "initial" 60 day comment period into September and October. 

Here's what's up so far.

MOLDX MAC (Palmetto, WPS, Noridian, CGS)

Go to the MolDx home page and see a link to a spreadsheet which is their gapfill protocol.  I'm glad they structure the process, but I see a few points of confusion.  For one example, labs filling out the form must list financials for "allowable indirect costs," but there's no hint provided as to what "allowable" means.   

No dates are posted, but I urge clients to get their data in "circa" the first week or two of February or as soon as practicable thereafter.  For questions, try  .    


They've just posted a website for the gapfill process!  They ask for responses by March 8, 2021.  Find it here:  for link  

FCSO leads the reader to a "surveymonkey" website for entering basic data required for gapfill by regulation, such as "charges" and "prices of other payers" and "resources required to provide the test."

Novitas MAC

Novitas has newly posted gapfill instructions on its website, asking for response by March 8, 2021.

(Novitas and FCSO are both owned under the umbrella of Florida BCBS, and both point the reader to a "survey monkey" website.  The rest of the text on the two MAC websites seems to match, too.)



Around Feb 1, NGS MAC emailed me they would NOT gapfill any PLA code not in their states.  However, in mid-February, NGS MAC posted an article that they WOULD be gapfilling ALL 2021 gapfill codes.   The article is here, an email is provided, and the due date set to March 19.  Archive here.

Original Blog in pale blue:

I emailed NGS MAC policy staff, and they replied "[we] only need to do gapfill on PLA codes for labs based [in our own] states."  

However, CMS policy staff in Baltimore advised me that all MACs will be requested to submit gapfill for all 2021 gapfill codes.  And this is what CMS has always expected in the past several years, that all MACs submit prices for all codes in the annual gapfill channel.    In addition, this is what the public CMS webpage indicates:   For any new test code that will be gapfilled, we request our MACs to develop MAC-specific gapfilled amounts for each test code and report the amount to CMS by April 1 of the following year.  Here.

I think the confusion is a understandable misinterpretation of a remark in CR12080 (here) that "MACs shall only price PLA codes for laboratories within their jurisdiction."  In context, CMS is referring to the rolling, quarter by quarter release of brand new PLA codes, and not to the annual formal gapfill process for designated new codes resulting from the annual summer meeting.  

Here are two summary slides from the information above:

Crosswalk, Gapfill, Flow Chart (click to enlarge)


MAC Table (see blog for details) (click to enlarge)


I've archived a cloud copy of the Surveymonkey here.

For footnotes to CMS website, MAC websites, here.