On May 1, 2024, CMS runs the new proposed gapfill rates up the Maypole to see what people think.
The webpage for CLFS crosswalk and gapfill rates is here:
Scroll down to the section, "CLFS Gapfill Determinations." There you'll find a cloud file labeled with: 2042 Preliminary Gapfill Determinations. The active file is an Excel called, "CLFS_Gapfill_prelim_for_CY25_Final.xlsb.
Files and Comments
These 29 codes are "gapfilled" because CMS could not determine a "crosswalk" price during summer 2023.
This Excel file has 2 tabs. The first page is pricing by CLFS district, of which there are 57 (all the states plus a couple at two per state, plus DC zone, Puerto Rico zone.) The second tab is "rationales."
For comments, CMS writes, Comments may be submitted to clfs_inquiries@cms.hhs.gov by by 07/01/2024.
Pricing Rule #1 and #2
#1 CMS sets the media price of the 57 CLFS zones; and #2, this is always the MolDx price, since it has a clear majority of states and always controls the median.
This year there were 29 codes in gapfill. My preliminary read is that many stakeholders may find their codes of interest are priced 20% or 30% lower than they might have expected, based on precedent codes of recent years. I believe that this is because MolDx prices more on its "Equitable Pricing Model" set of rules (which are an unpublished business secret*] rather than older precedents. This is not a loose paranoid guess; it's confirmed by the second "rational" tab, which states that "priced based on equitable pricing model."
Gapfillology
There are 29 codes in gapfill. 6 are Category I (80,000 series) codes. Helpfully, this year CMS included a short descriptor column next to the code number. One code, 0019M, is an adminstrative MAAA code. The other 22 or so codes are PMA codes.
5 codes are priced $2900-3500. This includes two of the 6 Category I codes.
7 codes are priced $890-1800, including four Category I codes in the $890-1350 range.
MAC Disparities Rise
Disparities were higher than I have ever seen. There were NO codes where the 3 MAC systems (MolDx, Novartis, NGS MAC) agreed. There were only 5 codes where MolDx and NGS MAC agreed (previously, NGS MAC had often matched MolDx).
There were 15 times the MolDx price was higher than at least one of the non-MolDx prices (out of 68 comparisons).
There were 5 cases where the Novitas prices were about $1500-2000 higher than the MolDx prices. In these cases, the NGS MAC price was close to (but not identical to) the MolDx price.
For the six genomic sequencing procedure codes at the top of the report, the MolDx prices add to $10,762, the Novitas prices to $19,741, and the NGS MAC prices to S11,203.
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Here are the gapfil codes with MAC price comparisons:
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Alzheimer
One Alzheimer code, 0412U, C2N Precivity beta amyloid 42/40, is $339. This is a multiplex test including ApoE and demographic facotors and an algorithm. This is not far off from last year's price for the Fujirebio FDA CSF Amyloid test (0358U).
But it's much higher than the Quest basic amyloid LDT (0346U). Note that there are some Alzheimer codes at the May 2024 CPT meeting, which will enter this summer's gapfill-crosswalk public meetings in June and July
7 Double Digit Codes
6 PLA codes and one Cat I code (87467 hep B) are priced in the double digit dollars, at $14-70.
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* I had a FOIA request for the EPM, which returned the reply, that EPM is an unpublished business secret.
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Nerd note. CMS released the file as .xlsb, I asked ChatGPT what "b" means. Here.