On November 16, 2018, CMS released final crosswalk (or gapfill) decisions for CY2019.
- See the CMS final crosswalk PDF here (41pp).
- 99 codes went through this new code crosswalk/gapfill process.
A Few Results
Thermo Fisher Oncomine FDA Test
The code for the Thermo Fisher Oncomine test, an FDA-approved lung cancer gene panel test covered under the CMS NGS cancer NCD, was originally proposed at a $600 price - much lower than its circa $2000 MAC price. The final CMS decision is to gapfill code 0022U in CY2019. Presumably, this will memorialize the existing MAC prices for the 2020 fee schedule. Because the NCD promises coverage to all FDA-approved tumor gene panel tests within their FDA labeling, there is likely to be an influx of tests from multiple venders (or sole source labs) popping up with FDA approval over the next 12-24 months. This should promote competition (for example, for turnaround time or sample size or gene panel or helpful remotes) against the Foundation Medicine test, a sole-source gene panel currently priced by CMS at $3500.
CMS also upgraded the valuation of 0040U (a high-sensitivity FDA-approved BRC/ABL1 test from MolecularMD) from 1x81206 (the legacy LDT price) to 2.5x81206.
Pan-Ethnic Carrier Screening
A new Category I CPT code for expanded carrier screening, 81443, is crosswalked to the existing code for Ashkenazi carrier screening, 81412 ($2448).
AMA CPT produced a new largely new set of BRCA codes for CY2019. However, as public data has previously documented, nearly all current CMS BRCA testing is either under codes 81162 (for combined BRCA1-2 full sequence and full dup del, $2027 in CY2019 and $1825 in CY2020), or under a gene panel codeset 81432/81433. New codes were created for BRCA1-BRCA2 sequencing alone, BRCA1-BRCA2 dup del analysis alone, BRCA-1 testing alone, BRCA-1 dup del analysis alone, and BRCA2 dup del analysis alone. (A code for BRCA-2 sequencing alone previously existed and isn't changed.)
Pricing of new BRCA codes was finalized, I believe, as proposed. Like with other codes, CMS used codes in the Tier 2 code set as price benchmarks when possible.
- 81163, B1B2 SEQ, is 81406+81216, or $282+$185, or $467.
- Code 81216, BRCA-2 sequencing alone, had a low PAMA price of only $185, which CMS is re-using here.
- 81164, B1B2 DUP DEL, is 81405+81406, or $302 + $282, or $584.*
- 81165 B1SEQ, 81406, $282.
- 81166 B1 DUP DEL, 81405, $302.
- 81167 is B2 DUP DEL, 81406, $282.
Prior codes, or similar codes, for these piecemeal BRCA services were virtually never used in either PAMA commercial payer data nor in CMS data.
Since the new codes have prices that would "code stack" below 81432/81433 or below 81162, they are unlikely to be used more than very rarely. (There is no incentive to use them, which there would have been if they code stacked to payments well above 81162).
As far as I could tell from the relevant AMA CPT meeting in San Diego in February 2018, AMA was simply proposing to make equal and similar codes for any possible combination of BRCA1 or BRCA2 sequencing or dup del analysis, regardless of how often that service was ordered on its own or whether it had any literature on its own.**
The 2019 prices can be appealed by submitting a formal appeal to CMS in the next 60 days. The result would be that the code you appealed will simply re-enter the crosswalk/gapfill decision process again next summer.
Two codes were under appeal (81326 PMP22, and 81334 RUNX1) and CMS declined to change existing pricing.
Gapfill = 18 Codes, Or About 18% of New Codes
Using a wordsearch method across the 99 codes, I counted 18 under gapfill (0018U, 0019U, 0021U, 0022U, 0023U, 0029U, 0030U, 0035U, 0041U, 0042U, 0043U, 0044U, 0048U, 0050U, 0053U, 0055U, 0056U, 0057U.) That's about the same number as were under gapfill this past season. In some cases CMS used gapfill because there was truly no comparable test; in other cases, because CMS was concerned that code stacking of CPT codes might not reflect economies of scale.
Your Little PLA Code Could Be $3873!
Several codes were finalized with a crosswalk to 81519, the Oncotype Dx test, including PLA codes that received this favorable pricing.
* Note that the Tier 2 system is quirky. Each tier reflects more extensive sequencing than the tier below, but there is a rank order anomaly between 81405 at $302 and the higher more complex code 81406 at $282.
** BRCA coding is now like those Staples ads, "Yeah, we've got that." AMA, you got a code for BRCA-1 sequencing alone? Yeah, we got that. OK, AMA, you got a code for BRCA-2 dup del analysis alone? Yeah, we got that.