Anyone notice, that as I said earlier, this release says the files were uploaded last Friday. There goes all the conspiracy theories
Dec 22, 2014
NEW YORK (GenomeWeb) – Shares of Exact Sciences rebounded today following a statement from the company that the Centers for Medicare and Medicaid Services had made an error in the 2015 clinical lab fee schedule for the firm's Cologuard test.
On Friday, CMS released the lab fee schedule, which establishes reimbursement rates for various diagnostic tests. According to the schedule, CMS set the National Reimbursement Limit code for G0464, which is assigned to the Cologuard colorectal cancer screening test, at $364.61, below the $502 reimbursement level that CMS had said in November that it would pay for the test.
The new rate resulted in a sell-off of Exact Science's stock and a 5 percent decline in its shares on Friday.
Later that day, however, the Madison, Wis.-based firm said that CMS had informed it that the agency will issue a correction to the 2015 lab fee schedule this week, and CMS would reimburse $500.76 for Cologuard, based on the national limit for CPT codes 82274, 81275, and 81315.
In afternoon trading shares of Exact Sciences rose aout 6 percent at $27.50 on the Nasdaq and were up as much as 8 percent.
I see a briefing about Fridays press release from Exact Sciences regards CMS telling them CMS will correct error.
Next press release should be about SEC filing on the completion of their offering including the 600,000 option being triggered.
I am surprised they didn't release it Friday
There won't be a CMS press release just like there wasn't a press release when the original files were uploaded to their site.
There wasn't a CMS press release about the error.
Exact Sciences did rhave a press release that CMS had verified to them there was an error.
CMS has removed the uploaded original flawed files
CMS is in process of fixing the error and will upload the files sometime in the near future.
You won't know files are uploaded unless someone here tells you or you check for yourself
Was that yesterday or Friday? I saw the creation date on Friday. I don't remember going to site yesterday. When I tried the link an hour ago they were gone.
As you have probably gathered from my latest posts what I meant from my comment
"OMG doesn't anyone realize the CMS error was there all along?"
was that the files whch were dated/created 11/17/2015 and must have had the error since that date.
It wasn't until I went and looked at the date of my post of the link that it dawned on me it was the same day that the files were created. Then I remembered that I have been checking the site all along, up to about a week ago, for the files and they were never there until I saw them the Friday. That answered my own question on why the Company did not discover error sooner.
This CMS webpage (which isn't updated that often), which is the homepage that links to the webpage that contains the ZIP files, was last Modified: on 12/19/2014 8:49 AM (I don't know what time zone CMS uses but it is probably EST as they are in MD)
I would then guess 12/19/2014 8:49 AM was right around time the files were uploaded
while 12/19/2014 4:13 PM was when they were removed
Just my 2 cents or less
Under My opnion #1 and #10 should read
1. CMS files were uploaded to CMS website the 19th or the 18th
10. CMS 12/19/2014 4:13 PM removed files from their website for correction.
Are all shot down IMO.
1. CMS files are dated 11/17/014
2. I posted placemarker link to the Files here on 11/17/2014
3. Around 12/8/2014 was last date I tried link and files were still not uploaded yet.
1. CMS files were uploaded to CMS website yesterday or the day before
2. Someone doing DD found the $364 figure yesterday and spreads word not knowing if it was error or not.
3. The selling begins
4. The news outlets picks up the story
5. The analysts contact the Company
6. The Company puts out PR and contacts CMS
7. The market closes
8. CMS tells Company it was an error
9. The Company puts out PR verifing error.
10. The buying starts
10. CMS today removes files from their website for correction.
That's interesting but reading reading comprehension really pays off off when you want to call someone out.
You won't find any evidence of me talking about an CMS error of any kind. I never found the error or said I did..
I said I posted a link to the zip file containing the 2015 fee schedule long before the link was actually working.
But what is really interesting is my link was posted here on 11/17/2015 the same date that the files are dated. I don't know exactly when the link became active (maybe yesterday??) but I kept checking it for at least 2 maybe 3 weeks and it still wasn't actvated. I hadn't checked the link in the last week until yesterday afternoon's debacle and that is when I found it was actvated
It is no longer active (now) because CMS has pulled the files down for the correction I assume.
If (I don't know the exact date) the files wern't uploaded to CMS website until yesterday then the timing and the short conspiracy theories go out the door. That also shows the company didn't have first hand look at the files and why they had no chance to notify the CMS of the error before uploaded. I would also now assume it was just a clerical error and not some CMS "option" hanky panky as some on here would like us to believe.
Here is link to my post.
Here is link to the file (not active again until corrected I assume)
Case closed as far as I am concerned.
OMG doesn't anyone realize the CMS error was there all along?
I long ago posted here, before the link was even working, the link to the zip file for 2015. The files are dated 11/17 if I am not mistaken. Suggesting that CMS or company was involved is ludicrous and not worthy of discussion. Why the company did not discover it and have it corrected before shorters had their day with it is another discussion.
Sorry I disagree. This was nothing. There wasn't a massive selloff nor was there massive volume and covering by shorts. A bear raid starts with massive shorting (which EXAS has) and false rumors etc (yeah we had one silly one yesterday) then the covering by shorts off the rumors. If this was true bear raid you would see it in the next short interest report for this time period.
We are offering 4,000,000 shares of our common stock. Our common stock is traded on the NASDAQ Capital Market under the symbol "EXAS." On December 15, 2014, the last reported sale price of our common stock on the NASDAQ Capital Market was $26.94 per share.
The underwriters have agreed to purchase the common stock from us at a price of $25.4583 per share, which will result in $101.8 million of proceeds to us before expenses (or approximately $117.1 million if the underwriters' option to purchase additional shares is exercised in full). The underwriters may offer the common shares from time to time for sale in one or more transactions on the NASDAQ Capital Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices.
The underwriters will also be reimbursed for certain expenses incurred in this offering. See "Underwriting" for details.
We have granted the underwriters an option for a period of 30 days to purchase an additional 600,000 shares of our common stock.
Investing in our common stock involves a high degree of risk. Please read "Risk Factors" beginning on page S-7 of this prospectus supplement, on page 4 of the accompanying prospectus and in the documents incorporated by reference into this prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The underwriters expect to deliver the shares of common stock on or about December 19, 2014
“The problem we are trying to solve is an ecosystem one, recognizing that if you have a weak link anywhere in the chain, it will delay patient access to important medical devices that are necessary to help them get well or save their lives,” Murray Sheldon, associate director for technology and innovation at the FDA Center for Devices and Radiological Health (CDRH), explained during the panel. “That was the position we came from with [parallel review], and we had the notion that if we could collaborate and work better with payers, we would be able to help influence and improve it."
Thus, the linchpin of parallel review is increased interaction between the primary stakeholders, ideally leading to a clinical trial design that meets the needs of all parties involved. “These conversations are very different and in the past have been very disconnected,” said Michael Tarnoff, M.D., Covidien’s corporate chief medical officer and moderator of the AdvaMed panel. “You can end up spending millions of dollars on a clinical trial only to have Medicare say that your endpoints are relevant to the regulator, but they are not as relevant to the payer.”
The parallel review model endeavors to avoid this scenario by bringing everyone together during the very early stages — starting with (or even before) an investigational device exemption (IDE) submission. For example, CMS may attend a pre-IDE meeting in what CMS’s Syrek Jensen called “listening mode” to get a better idea of what the proposed trial will look like. Then, it will provide its input and have conversations with the device maker and FDA later, often via email or over the phone. Suggestions might include enrolling older patients in the study or taking into account endpoints that you normally wouldn’t in a safety/efficacy-focused trial, like quality-of-life and economic measures.
In the opinion of Exact Sciences’ Conroy, this collaborative approach informed a much better result than going through two processes independently. “It was pretty straightforward —FDA gave its inputs on the clinical trial design, and CMS gave its inputs. They were really logical, and we incorporated them fairly quickly,” he said. “We ended up enriching the patient population for Medicare, which actually had the unintended consequence of shortening the trial.”
That’s the appeal of the parallel review concept. Everyone benefits from a more efficient process. Manufacturers avoid additional clinical trials and realize quicker returns on their product development investments. CDRH achieves its vision statement by providing U.S. patients with high-quality, safe, and effective medical devices — “first in the world.” And CMS delivers new technologies that have a meaningful impact on health outcomes to its population.
“If your particular device is something that Medicare should cover, because it’s appropriate for the Medicare population, I really don't want you to do another however-million-dollar trial,” Syrek Jensen explained. “I would prefer to get all of that answered up front, so we can get new medical innovation to the Medicare population quicker.”
And for a small company like Exact Sciences, a tighter reimbursement and regulatory review process could mean the difference between life and death. “Without [parallel review], there was no hope for Cologuard to get out of the starting gates,” Conroy added.
Interagency Coordination Outside Parallel Review
Today, very few manufacturers have the opportunity to participate in the official parallel review pilot, since eligibility is extremely restricted and the program is accepting no more than five devices per year. However, its two basic tenets — (1) engaging both CMS and FDA early and often in the process, and (2) addressing each organization’s unique requirements in your clinical trial design — are successfully being applied outside the formal program.
Take, for instance, the Sapien transcatheter heart valve from Edwards Lifesciences. The U.S. became the 43rd country in the world to gain access to transcatheter aortic valve replacement (TAVR) when Sapien was approved in November 2011. This fact was the butt of jokes throughout the AdvaMed conference (CDRH’s Sheldon quipped that at least we were ahead of Albania when it came to approving TAVR) and was used to illustrate the challenges associated with bringing new products to market in the U.S.
On the other hand, Sapien is also a great example of how device makers, FDA, and CMS are continually adapting to streamline the pathway to market for innovative technologies. While Sapien wasn’t part of the parallel review program proper, Edwards did emulate aspects of the process by regularly connecting with FDA and CMS prior to initiating its clinical trial — and by so doing reaped some important benefits.
Speaking in the AdvaMed panel, Larry Wood, corporate VP and GM of Edwards’ transcatheter heart valves business, said that based on early conversations with CMS, the company went out of its way to make health outcomes a focus of its clinical studies for Sapien. “Those discussions were very helpful, because we always focus on mortality and complications, but we found out that quality of life was maybe the most important thing for CMS,” he explained.
Plus, he said, it would be naïve for manufacturers to think that FDA and CMS don’t talk to one another about devices that fall outside the purview of the parallel review program. “They’re going to be talking anyway,” he added. “You either want to have a seat at the table or not.”
As a result of Edwards’ continual engagement with the agencies, and its attention to their wishes in its clinical studies, CMS ended up initiating an NCD for TAVR two months before Sapien had even received approval from FDA. This highly unusual circumstance (CMS rarely covers devices that are yet to receive FDA approval) ensured that Sapien would be reimbursed when it hit the market.
What’s more, the agencies decided that any future label expansions for Sapien approved by FDA would automatically receive Medicare coverage. The device was initially approved for use in inoperable aortic stenosis (AS) patients but has since received several indication expansions, each covered by CMS the minute FDA gave its approval.
CMS’s Syrek Jensen believes the TAVR NCD could serve as a template for expediting Medicare coverage for other types of devices, and pointed to postmarket data analysis as key to its success. “The reason we allowed for the NCD to expand along with the label is because we were confident that the post-approval studies — the registry in this case — was a way for us to continue to look at the data as that happened,” she said. “I think this NCD is a model, potentially, of what we could do. It doesn’t seem efficient to continually reopen an NCD every time the FDA expands the label.”
Speaking of labels, another advantage of interagency collaboration is that CMS can provide input on the label, weighing in on how its wording could impact CMS coverage. According to Syrek Jensen, while labels don’t fall within CMS’s jurisdiction (that’s FDA’s turf), several manufactures have found it advantageous to seek the center’s perspective on them.
Count Exact Sciences’ Conroy among the believers.
“I think this is a good example of where having multiple parties in the room at the same time is helpful,” he said. “The FDA comes up with a label that is very clinically oriented, and in that room is a trusted party from the other side of town that is able to weigh in on what it means in the real world.”