There's a huge amount of news every week about liquid biopsy in cancer management - even more this week, with the bonanza of reports at ASCO. Here, here.
Medicare's coverage is a little confusing, so I'll briefly recap here.
CDx and Hereditary Risk (FDA). Medicare has a national coverage decision NCD 90.2 governing the use of FDA approved or cleared NGS tests in cancer - both companion diagnostic tests and hereditary risk management. This NCD covers the use of NGS tests as companion diagnostic, among them CDx liquid biopsy tests, on a rolling basis as they are approved by FDA.
Currently the FDA CDx liquid biopsy tests covered under NCD 90.2 are the Foundation and the Guardant PMA LBx NGS tests. The FMI test is 0239U, the Guardant test 0242U.
Screening for CRC. Separately, CMS has a national coverage decision for liquid biopsy screening tests for colorectal cancer, IF they meet sensitivity and specificity standards already set by CMS. Several such tests for CRC screening will likely be approved by FDA in the next several years, and in essence, the CMS NCD coverage is "pre written" or "pre fab" awaiting them. See the CRC NCD, 210.3, version 6. See an implementation guide from CMS, here, here.
MolDx: CRC Management. In 2019, MolDx promulgated an LCD covering the use of the Natera Signatera test in colorectal cancer management. This was proposed as DL38290, with Signatera as the name-brand test in the LCD title. It was finalized as L38290, which removed "Signatera" from the LCD title, and focuses on the Signatera test but is not specific to that test alone. The original proposal is still online here. The final version is here. This is MolDx's current active LBx MRD coverage.
L38290 or an identical version with a different code number is active at three different MolDx MACs - WPS, CGS, Palmetto. Quirkily, and in contrast, the fourth MAC, the one Natera actually bills to, Noridian, covers the test by an "article" that recapitulates the text of the MolDx LCD used elsewhere. See article A58449.
MolDx: Pan-Cancer Management. Since last August, MolDx has a new and broader liquid biopsy LCD under review, DL38779. This will (A) have coverage for most all kinds of cancers (both solid tumors and hematopoietic cancers) and (B) cover two major intended uses, recurrence monitoring (such as after colectomy) and determining therapy response. It should be finalized by August 2021. See the "four-square" table immediately below.
|click to enlarge|
- EXOME TEST AND PLASMA TEST SERIES BUNDLE (UP to 4)
- EXOME TEST AND PLASMA TEST (no remark on bundle, so presume 1 exome, 1 design, 1 plasma test)
- NO EXOME TEST; PLASMA TEST DESIGN AND SERIES BUNDLE (UP to 4)
- (Patient has a previous exome test from somewhere used to design the bundle 4 test plasma test)
From the table above, it looks like the exome is valued at $2720. This is because exome and four plasma tests (top row) are $5897, but the four tests without the exome (bottom row) are $3177. We can illustrate it like this:
In the box above, note from the bottom row that 4 plasma tests w/o any exome test are $3,177. This suggests a price per test of $794.
There's just one box we haven't addressed. If we assume the first column is valued at $2720, and the third column is valued at $2019, and all three columns add up to $5897, then the middle column - what we're calling "first plasma test" - can be gapfilled at $1158 ($5897-$2019-$2720 = $1158). Shown next: