Medicare (see here) covers three fecal-based diagnostic tests:
- FOBT testing (fecal occult blood aka guaiac testing, which requires multiple tests and avoiding meat consumption ;but costs only $4.77)
- FIT (fecal immuno occult blood testing; $21.77).
- Exact Sciences Cologuard (FIT + DNA testing; about $500)
How commonly used are the classical fecal tests in a country which seems to have a near-gold-standard of jumping right to colonoscopy? Details after the break.
Using the 2015 Part B provider database, I pulled all uses of CPT 82270 (screening FOBT) and G0328 (Medicare code for ImmunoFOBT).
Usage of FOBT and FIT Close to 1:1
Usage of the two fecal tests were close to 1:1, with 595,000 patients for FIT and 438,100 patients for classic FOBT. Due to the difference in per test cost, spending for FIT was $12.5M and for FOBT, $1.9M.
The distribution of providers was very different.
The $1.9M of FOBT testing is a cottage industry - thinly distributed, with no provider doing more than $10,000 of testing and most well under $3000 of testing. A number of physician practices were among the top 20 providers. Only $140K of services of $1.9M were from "clinical laboratories."
In contrast, the $12.5M of FIT testing is more centralized. 100% of the top twenty providers were labs, and they held about 20% of the annual market. Overall, labs did $4.0M of FIT testing, or 32% of $12.5M. But that still leaves 68% of FIT revenue for clinicians.
For both FOBT and FIT tests, several hundred medical practices provided >200 tests per year.
Coding note - FIT, used for Medicare screening, should be coded as G0328, but CPT 82274 is also a correct code for FIT testing and had a separate $8.2M of services.
In 2015, Exact Sciences provided 58,446 Medicare services for Cologuard at an average $492, totaling about $2.8M. Cologuard revenue exceed FOBT revenue in its first year of release, and reached about 10% as many patients. In July 2017, Exact Sciences boosted its 2017 sales projections to $230M-240M (here).
Penetration of FOBT Tests
Since there were about 1M total FOBT-like tests, and there are about 35M Medicare Fee for Service patients, usage was about 1 per 35 Medicare patients.
Comparison to Colonoscopy
Colonoscopy data is harder to aggregate because there are screening codes, as spending is split between physicians and facilities, the test may reflex to diagnostic biopsy, there are anesthesia and pathology services, etc. However, a 20 page analysis turned up at the HHS/ASPE website here. This report tallies 1.9M total colonoscopies in 2015, with associated expenditures of $1.3B. In comparison, all fecal testing costs totaled about $17M. Total colonoscopy costs were about 1% of all Medicare Part B costs ($131B). 80% of colonoscopies were performed by gastroenterologists.
In the ASPE white paper, 392,800 cases were directly classified as "screening colonoscopies." I am not sure how many colonoscopies are classified as "diagnostic" but originated in a screening process. Ideally, a screening colonoscopy would be coded as G0121 and a diagnostic colonoscopy coded at CPT 43579ff but with a modifier PT when it is reflexed from a screening colonoscopy. It was unclear to me whether the white paper I am citing recognized the PT modifier and pulled all such cases out of the diagnostic category and into the screening category. (Also questionable is the accuracy of use of the PT modifier during claims submissions.)
The ASPE report tallied $322M of screening colonoscopy costs with $12 average for pathology. The fact that average pathology was $12 rather than "zero" suggests they may have been tallying diagnostic colonoscopies with PT modifier as screening colonoscopies. (Diagnostic colonoscopies had an average of $75 in pathology costs.) Office based colonoscopies are possible in Medicare but are priced so low they are very uncommon (60,000 out of 1.8M services).
Bottom, line, a simple first pass view would be that FIT/FOBT/Cologuard costs in 2015 came to about $17M and screening colonoscopy costs about $322M or a ratio of about 20:1.