CMS Publishes Final Decisions on New Lab Codes for CY2022

Each summer, CMS has public meetings on how to price new lab codes.  CMS publishes proposed prices in September and final prices in November.  The final prices are out.

Go to this web page at CMS and scroll down for CY2022, Final Payment Determinations:

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

I've also put a cloud copy here.

Statistics

98 codes were in play.  This is about the same as last year.  But before coding reform, before 2011, there were only 5-10 new lab codes per year.

See my blog on the proposed codes in September here. CMS disagree with its advisors 57 of 99 times, which I'm pretty sure is a record.  As you'll see below, it almost never changed its mind, either.

How many PLA codes?

I tallied 60 of them as PLA codes (ending in ---U).  

How many were gapfilled?

35 of the 98 are gapfilled.  This is a bit less than this year, but it's still alot.  Before coding reform, often 0 codes per year were gapfilled. 

What does "Comment Period" do?  Does CMS change its mind?

CMS made almost no changes in its proposed decisions this year.  Usually CMS changes its mind a dozen or more times; this year, only 3 times.  

• Most noteworthy: 0261U, HalioDx, 4-slide colorectal cancer test, with AI, crosswalk to 0108U, a multi-slide Barrett's test, for $2513.  [*] HalioDx acquired by Veracyte in mid-year; here

This lack of changes could mean that CMS made its proposals very carefully (even though it disagreed with the expert panel the majority of the time), and was unlikely to hear any really "new" information during the comment period.  Or, it could mean that CMS doesn't listen to the comment period.  (I think the former).

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Besides 0261U conversion to crosswalk, two other codes changed (always by conversion to crosswalk.   These included 0247U (CW 0063U, $750).  It is a 2-immunoassay test with algorithm for preterm birth risk.   And 87428, antigen immunoassay for COVID and FLU, priced to a simple crosswalk (87430&87400) rather than the 2X crosswalk panelists recommended.   O

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[*] Not mentioned on this crosswalk report, since it was a summer 2021 gapfill code that did not change price, readers interested in the $2513 pricing for 0261U and 0108U shown above, might want to keep track of 0220U, image analysis of breast cancer slides, $706 (priced this year during gapfill).  

In December, it was announced that Castle Biosciences closed its acquisition of Cernostics (AI slide imaging) for $30M - here.  Although not associated with coding, see also the FDA de novo authorization for slide-based AI imaging for Paige AI in September 2021.