Ranjo- Thanks for the update. I haven't listened to the call. Per USPSTF they will normally issue guidance 1-2 months after the Public Comment period ends. If they are going to delay the decision because of so much push back then I would expect the recommendations to change somewhat. I think KC is just being conservative as always. At the least the USPSTF needs to clarify A,B,I, recommended and alternative and I think the worst is baked in and any surprise is on the upside. Why take an extra year and not change anything?
Highly unlikely they get an "I". This is just a statement of the current recommendations since the 2015 Draft decision is not yet final
Trg - even worst case scenario and USPSTF keeps it as an acceptable "alternative" test I think HEDIS will have to accept it as valid since it is an approved alternative test. Payers will go crazy if they pay $500 and it doesn't count towards their quality measures- especially since it's an every 3 year test. JMHO.
Spoke with someone who was at a recent NCQA meeting where they were discussing measure specs for 2016. I don't think they make decisions until the summer but they said there was ALOT of talk from payers about including CG in the new specs for CRC screening. It would likely be retroactive for all of calendar year 2016.
You're right HS - they make the argument that CG should be recommended in a convincing way then back off in the conclusion and say it should have a "B". But, if they change to a "B", and I think there is a decent chance of that, and take away alternative then it's a big win for EXAS as it gives insurance coverage and a high rating which is only lacking more long term data. Where do you think the stock would be if it got a "B" out of the gate? I's say it would be around 20.
Capitol - presently I think the biggest issue is insurance coverage. With straight Medicare it's easy (that's 50%) but with everyone else you don't know if it's covered by their insurance, and it's not easy remembering who covers and who doesn't and most of the time you aren't even aware of what insurance the patient has. It takes too long to explain the test AND the cost the patient could be stuck with. Also, remember only 50% of docs even know what CG is! It's only been 1 year since it's been out and it's a new paradigm. I agree with Busygoth - It will be a great success- just a little slower uptake than folks thought.
It's not as if the colonoscopy isn't covered as medically necessary. It's just not a "free screening" Like any other medical test or visit you pay for it until your deductible is met. If your deductible is met it is a totally covered procedure. No different than the xray of your broken arm won't be covered until your deductible is met or the biopsy after your abnormal mammogram, etc.
I think we can reverse course with solid revenues/tests completed and forecast next week.
KC said we'd hit 32K. I am hoping for 33-34k with a forecast of 46-47k for q4. That would beat WS revenue forecasts and calm WS fears about a dramatic USPSTF downturn in the near term. 32k and 45k would meet expectations. Anything better is gravy. Thoughts?
Susu - I agree with you that I think they (USPSTF)made the correct decisions about Mammos' and PSA. The data was strong and over a long period of time. Where they go wrong is when they want "outcome" data (morbidity and mortality) that will take many years to produce for new tests and they have excellent RCT's and can use modelling to accurately predict the benefit of something. They missed the boat by 10 years with HPV testing because of this. They ignore common sense. Sensitivity of CG is far superior to FIT especially for precancerous lesions. The compliance is far greater with q 3 year testing and the compliance engine. Cancers are found at earlier stages and the small difference in false +'s only result in the test they most recommend. They are doing a disservice by letting the perfect be the enemy of the good and delaying support for this test for many years to come. Sometimes you need to get off the academic high horse and use common sense while you wait for "further studies"
DoctorJ- virtually nobody here bought because we thought it would replace colonoscopy. We bought to replace the Millions who use an inferior FIT/FOBT test and for the Millions who refuse colonoscopy, just as the company has always stated.
Informed consent RE: USPSTF isn't a big issue for CG. Millions of woman get Mammograms in their 40's despite the USPSTF to wait for 50. Millions of men get PSA testing despite the "D" recommendation. Millions of women got HPV testing despite the "I" recommendation. The same will be for CG. Yes, Docs should inform patients that Colonoscopy is the gold standard. But for those who refuse it or just want other options they can say the USPSTF sees it as an Alternative test" but that it is recommended by CMS, FDA, ACS, AGA, ACOG etc and use their own personal recommendations for an informed patient decision.
Kcam- old Digene buddy. I'm sure you had the same paranoia about USPSTF as I did. I took some off the table but wish I had followed my gut more. They screwed us again. Hopefully, it will end up the same as well. I think it will. How's the adoption among your GYN friends?
Oldguy -yes they have unprecedented power but I am not a conspiracy theorist. I think they made a bad decision but they are data and outcome driven and unfortunately a new test can't prove it saves lives when it's diagnosing a cancer that takes 10 years to kill you and they want this type of outcome proof. Forget about common sense. Now if they actually used wrong Specificity data or modeled CG for Annual and not q 3 year testing when determining false positives then that is WRONG and should be corrected.
Highscorer- agree overall. I think the 1 potential big short term catalyst would be if Exas can get clarification on whether the "alternative" tests are actually part of the "A" recommendation. This could potentially be clarified before the comment period is over if it is simply a miscommunication issue by USPSTF. They are very unlikely to add CG to the recommended category but If it is part of the "A" recommendation then the insurers will have to cover it eventually and the driver of growth then becomes not coverage but patient and physician acceptance. I believe patients and providers will choose CG in large #'s despite it not being in the "recommended" category because it makes sense.
People need to understand that the USPSTF is not like other agencies in that it requires multiple studies and outcome data to make decisions. It is often behind the curve in medicine for this reason. Logic does not play a big part in their decisions - never has.
A perfect example is cervical cancer screening and HPV testing. The whole medical community adopted HPV testing way before it was recommended by the USPSTF. The USPSTF gave it an "I" recommendation for years and this was ignored by the medical community because it didn't make sense. They eventually gave it an "A" recommendation- many years after it was the standard of care.
If we get the "A" classification this "alternative"decision will hurt a little and slow growth some but I think the patient and provider demand will overcome the recommendation in time because most folks don't need further outcome studies, interval studies, etc to realize that the combination of higher sensitivity and an excellent compliance engine makes it a better test than fit and because more people will actually gets screened.
Millie- A or B and mandatory coverage- that is the big question. It is not clear to me after reading the USPSTF draft. CG is not listed as one of the recommended tests (it's an alternative) and is not listed in the Update of Previous USPSTF Recommendation" KC does not state in the press release that it got an A or a B. If this was the case he would have clearly stated it. I am as long as anyone on this board but I am not as optimistic as some are saying that this is not a disappointing draft decision. It was always my fear that without "outcome" studies the USPSTF would not be a slam dunk. Hopefully we get some clarity tomorrow on this issue.- because it's not clear to me.
Yes the study was WITH a bowel prep so it is needed to screen. Big disincentive. Also these patients were symptomatic and high risk, they excluded all IBD patients because it didn't work and 25% of patients had adenomas or cancer. This has very little to do with screening an average risk, asymptomatic population without a colon prep. Not a competitor to CG anytime in the near future.