81275, KRAS key exon analysis, seems like a prototype precision oncology service that was well-accepted by CY2015. Medicare paid for 8,926 services for $1,790,777 dollars. (This data source does not include billing by hospital reference labs as an outpatient service, and does not include low volume providers of <10 services).
The top ten providers of 82175 KRAS services accounted for 73% of volume. The top 5 providers accounted for 50% of volume; Caris narrowly led Bioreference and Neogenomics. Interestingly, neither Labcorp nor Quest show up in the Medicare Part B top 10 when sorted by KRAS dollar volume. Note that the rightmost column is cumulative percent-dollars; click to enlarge.
81235, EGFR key exon analysis, was a more popular code in CY2015. For 12,180 services, payments were $4,107,534. The top ten providers of EGFR billing accounting for 80% of the volume, and the top 5 accounted for 59% of volume. Caris replaced Clarient as the top biller.
There May Be Services We Don't See
The MolDX program has elaborate rules for coding of multiple CPT's for genetic tests and for use of NGS even for 1-4 tests, and may use special coding for certain FDA-approved CDx kits. These may result in additional cases of 81275/81235 services shunted into the 81479 unlisted code billing pathway, and therefore not seen in this data pull. This could be impactful in terms of KRAS volume metrics, because MolDx MACs handle about 87% of Medicare Part B payments (here). (For MolDX claim submission rules here, for more on 81479, here.) That is, KRAS seems to be 0.37% of Medicare Mopath payments, but it could be more. EGFR tallies 0.8% of Medicare Mopath payments. Or, together, EGFR and KRAS, as 81275/81235, were about 1% of Medicare Mopath payments.
Some important precision oncology tests, like FISH- or IHC-based ALK fusion services, can't be seen in Medicare data because they are processed through generic FISH and IHC codes.
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Example of further analysis; you can download data by company
We noticed that CARIS was the #4 provider of KRAS testing and the #1 provider of EGFR testing. We can then search the CMS database for all payments to Caris. We find that: CARIS MPI provided $9,987,219 of total Medicare Part B services. This $10M of CMS billing was distributed across 20 CPT codes.
The top CPT code for Caris was $2,825,656, for 10,270 services of 81404, Tier 2 Level 5 (average payment $275). The second-highest Caris CPT code was 88360 (FISH), with 12,735 services for 2,362 beneficiaries, for $1,709,404. These two codes were 28% and 17% of Caris payments, or 45% of all Caris payments.
While Caris ranked as the #4 national provider of KRAS services, within its own payments, KRAS for Caris was just line #12 --- with 782 services at an average payment of $197 for $154,000. KRAS was just 2% of Caris's total CMS payments.
Caris was paid $275 on average for its highest-dollar volume code, 81404, Tier 2 Level 5. This was quite close to the national average of $263 for Tier 2, Level 5, a code which doesn't have a fee schedule price.
