Wednesday, September 22, 2021

CMS Posts Final Gapfill Rates for CY2021 Codes Under Gapfill

CMS has published the final MAC Gapfill rates for CY2021, finalizing the MAC gapfill rates initially proposed in May 2021.

Find the rates on this webpage:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings

Scroll down to the header, GAPFILLING DETERMINATIONS, and see the file, "2021 CLFS Gapfill Final Determinations."   (I had to reload my screen a couple times for this to appear.)

To read about today's proposed CLFS prices for NEW codes, to be used in 2022, see here.

Initial Findings

There were 53 codes in the gapfill process.  By reference to tab 2, "Rationales," 20 of the 53 codes received pricing comments over the summer, because they have some kind of rationale remark in response.  

  • Four codes were revised at enough MACs to change the median rate calculation (0156U, 0165U, 0178U, 0219U).   
  • That's it.
  • All the other codes were not revised, suggesting that gapfill prices are pretty "locked in" when first published in May.
  • Most codes had no changes anywhere, despite CMS having logged comments.
  • One code had changes "at some MACs" but not enough to change the median.
CMS notes that two codes were transposed (0206U, 0207U). These are quite different, 206U being $2215 and 207U being $511.  However, both of them belong to the same lab and are closely related processes.

The 4 revised codes were...

0156U - SMASH, NY Genome Center, NGS cytogenomics, $1740.  Up from $597.
0165U - Verimap peanut allergy, $463.   Up from $218.
0178U - Other Verimap peanut allergy test, $459.   Up from $218.
0219U - Gene analysis of HIV, $725. Sentosa, Vela Dx.   Up from $386.  

Codes 0152U (Karius Test) had a price elevation in the NGS MAC states from $2126 to $2919, but because other states didn't change, the national median remained $2126. 

Gapfill Appeals

CMS states, "Once we post the final MAC-specific gapfilled amounts to our website, we accept reconsideration requests on the final gapfilled payment amounts for new and substantially revised test codes for 30 days."  

There isn't much published on this; you just write up your complaint and submit it to CMS promptly.  

Does CMS really change gapfill prices in October based on this "final gapfill price appeal?"  Yes, it happens maybe once a year.   But there's no public data for how many companies submit appeals, so there's no way to estimate the odds of success.

Can CMS lower your price, when you appeal for an increase at this point?  I can't think of a case where a gapfill price has dropped between the "final" September price and the end of the year, that can be attributed to a stakeholder appeal of the September price.  But I'm not sure that it's impossible, so one might consider losing ground during the final gapfill appeal as a low but nonzero risk.   
 
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CMS initially said in the "comment rationales" that 0016U was priced as it was, because it was similar to "81452," a non-existent code (a typo), later revised to "81542," a prostate gene expression test.

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Change Tally.

  12 codes - no change is warranted.
  1 code - "Similar to 81452" - and no change.  
13 codes - no change was warranted.
2 codes - transposed, but belonged to same owner (0206U, 0207U)
1 code - some MACs changes, but no median change (0152U)
4 codes - price changed.

13+2+1+4 = 13+7 = 20.

Meaningful changes = 4/20 commented = 20%.

Meaningful changes = 4/53 codes under gapfill = 8%.