Saturday, November 21, 2020

CMS Posts Final Pricing of New CY2021 Lab Tests


On November 20, 2020, CMS closed out the new codes crosswalk/gapfill process for CY2021, by posting final pricing decisions.   

In a striking contrast from Fall 2019, CMS did not change any of the pricing decisions proposed in September 2020.

  • Last year, CMS disagreed with the advisory panel about half the time in its proposed decisions (September 27, 2019).  Last year, CMS changed about 20 codes between proposed and final (mostly by changing crosswalks to gapfills; December 4, 2019.)
This year, of 132 posted decisions, CMS disagreed with the panel on 8:
  • On 8X008, JAK2, exons 12,13, and on 8X006, MPL, common variants, CMS crosswalked to Tier 2 codes rather than specific crosswalks (agenda 95,96).  
  • Agenda items 40-45 were crosswalked to drug code G0480 rather than gapfilled as recommended  by panelists.
I tally 53 gapfill codes, which will keep MACs busy with pricing exercises in 1H2021.  

Most codes priced by CMS were simple single crosswalks. Of 78 crosswalked codes, the several exceptions were these:
  • Two CPT codes were added together to price 3 new tests. 
  • CMS used fractions three times: 
    • One code was multiplied by 2.5x, and two codes were a base code and fraction of a second code. 
Category I MAAA code, 81XX1, agenda 66, 190 genes for pulmonary fibrosis, was converted to an ADLT code.  It's ADLT'd at $5500 (here).  It's the 7th ADLT.  The prior ADLT was back in 12/2019, the Myriad MyChoice FDA-approved enhanced BRCA test, $4040.  The highest priced ADLT is a melanoma MAAA test at $7193.


Of high interest to many, CMS COVID codes U0001-U0004 were set to gapfill, as proposed in September, and as recommended by many panelists.  However, at least until the end of the public health emergency, prices of U0003-U0004 are set by administrative order ($100 in 2019, $75 in 2020 if >72 hours but allowing a $25 rapid test report supplement if faster).  I believe these codes would be come unpriced at the legal ending of the PHE which is why CMS is putting them through the CLFS process.


Find the spreadsheet at this CMS webpage HERE, scrolling down for the Zip file of the Excel file "CY 2021 - Clinical Laboratory Fee Schedule Test Codes Final Payment Determinations (ver. 1) (ZIP)."  CMS occasionally finds errors and updates the file.  Final prices will also appear in December on the release of the entire CLFS (including both new and old codes) for CY2022.

Stakeholders can appeal the method of payment until January 20, 2021 (see spreadsheet, top row for instructions).  Appealed codes are simply put back into the CLFS pricing process again in June 2021.