Is this true or misprint?
2015 National Training Manual. Page 20.
The table is dated 5/1/2015 and collaborates the statement below.
"All Medicare beneficiaries 50 and older who aren’t at high risk for colorectal cancer are covered for the following screenings:
Barium enema every 4 years when used instead of a sigmoidoscopy or colonoscopy
Multi-target stool DNA test (Cologuard™) every 3 years
All Medicare beneficiaries 50 and older who are at high risk for colorectal cancer are covered for the following screenings:
Barium enema every 24 months as an alternative to a covered screening colonoscopy
Multi-target stool DNA test (Cologuard™)
People with Original Medicare don't pay a deductible for a screening barium enema but you pay the Medicare-approved amount for the doctor’s services. In a hospital setting, you pay a copayment. There is no deductible or copayment for the multi-target stool DNA test. "
This is old
By Cable Car Capital LLC
While stock market indices had a roller coaster October, the Hedged Value portfolio was relatively stable and remained focused on the long term in my opinion.
In general, one potential benefit of a long/short portfolio is reduced volatility during market downturns, possibly freeing up capital and attention to focus on core positions.
One position that moved against Hedged Value during the month and drew added scrutiny was Exact Sciences (EXAS). EXAS is the developer of Cologuard, a stool-based DNA test for colorectal cancer (CRC).
Cable Car is short EXAS, primarily on the basis that the potential addressable market has been exaggerated.
I believe commercial adoption of the test for CRC screening will be slower and less widespread than many investors anticipate.
On October 10, EXAS rose over 30% when the Centers for Medicare and Medicaid Services (CMS) proposed a preliminary payment level for the test of $502, well above expectations.
I believe that this proposed reimbursement rate would impose unnecessary costs on the healthcare system.
There is a large body of research that suggests Cologuard would not be cost effective at the proposed payment level.
Rather than simply waiting for CMS to issue its final pricing determination, Cable Car engaged in some mild activism in support of its position by participating in the public comment process.
Cable Car published a letter to CMS explaining why I believe the test deserves a lower payment level.
For readers interested in learning more about the economics of diagnostic tests and Cable Car’s investment approach, the letter is a good example of the kind of fundamental research that supports each investment decision.
Even if reimbursement remains high, I believe EXAS has a higher valuation than it deserves. Cable Car added to its short position in EXAS in October.
Annual Laboratory Public Meeting
Calendar Year 2016 Updates
July 16, 2015
G0464 Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g.,
KRAS, NDRG4 and BMP3)
That Hedge fund tried it last year and it failed and it will fail this time. They better be covering
A. Drug Testing:
In the 2015 clinical laboratory fee schedule final determinations file, we decided to not pay for
new CPT codes for drugs of abuse testing. We stated our concern about the potential for
overpayment when billing for each individual drug test rather than a single code that pays the
same amount regardless of the number of drugs that are being tested. Therefore, we delayed
pricing for these codes to allow additional time to study the issue. However, we agreed with
commenters that this policy would leave insufficient codes available to bill for drugs of abuse
testing. For that reason, we maintained the 2014 status quo for 2015 by creating alphanumeric G
codes to replace the 2014 CPT codes that were deleted for 2015. For 2015, providers are using
these G codes in the same manner in which they used the corresponding CPT codes for 2014.
In addition, for some of the drugs of abuse testing codes, the AMA CPT did not delete the 2014
code numbers, but revised the instructions or code descriptors in the 2015 CPT Manual.
Following these instructions would have left providers without billing options. Thus, we also
instructed the public to use these G- codes exactly as they used them for 2014, regardless of the
2015 instruction or code descriptor changes.
After further consideration of this issue, several meetings with the public, and in consultation
with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the
Office of National Drug Control Policy, we are proposing to modify that policy as follows:
1. Delete the following G- codes:
G6030 through G6058 (28 codes)
2. Continue to not recognize the following CPT codes:
80300 through 80377 (64 codes)
3. Create two G-codes to be priced at this meeting:
B. Code List
Please note that this listing includes the most recent codes provided by the American Medical
Association (AMA), and that it is subject to change. Any changes will be updated as they
In a research report issued on Friday, William Blair analyst Brian Weinstein offered some insights EXACT Sciences Corporation (NASDAQ:EXAS) following the company’s first investor day held yesterday. The event included a review of the Cologuard launch, a discussion of the growing pipeline, and a tour of the lab and customer service center. Weinstein rates EXAS shares an Outperform without providing a price target.
Weinstein noted, “Our overall conclusion from the event is that the Cologuard launch is tracking at or above our expectations and gaining momentum ahead of an important USPSTF decision (which we have intentionally been conservative at assigning a 70/30 chance of going in favor of the company’s product attaining an A or B rating).”
“At the same time, the company is establishing a broader infrastructure to assist in the evolution into a platform technology player focused on early detection of cancers and pre-cancers. The success of these additional programs remains a very large question mark, but the idea that Exact is broadening its reach and partnering with major players in the industry should be seen positively by the investment community.”, the analyst continued.
The US Preventive Services Task Force, or USPSTF, is expected to publish its revised guidelines for colorectal cancer, or CRC, screening in the third quarter of 2015. The guidelines should include an assessment of Exact Sciences' (EXAS) Cologuard, an "easy to use, noninvasive colon cancer screening test."
ANALYST TAKE: The USPSTF guidelines were noted as "the last binary event for Cologuard" by Jefferies and "the major overhang" for Exact Sciences by Mizuho Securities. Jefferies analyst Brandon Couillard and his team, which rate Exact Sciences a Buy with a $33 price target, see "significant upside" from a favorable outcome and said their thesis was boosted by confident comments from a "former affiliate of the USPSTF's review board." Mizuho analysts Peter Lawson and Eric Criscuolo, who rate Exact Sciences a Buy with a $35 price target, said they believe Cologuard will receive an "A" or "B" rating from the USPSTF, triggering further adoption by mandating coverage of Cologuard by private insurance. Baird defended Exact Sciences after the stock dropped 5.5% on Thursday, June 25, saying Exact Sciences' investor relations day was "bullish" in tone as the company provided a "deep dive" update on its Cologuard launch. Baird maintained its Outperform rating and $44 price target on the company.
PRICE ACTION: Over the past week, shares of Exact Sciences are up more than 5% despite Thursday's 5.5% pullback. Over the last month, shares are up about 12% and over the last three months they are higher by almost 40%
In a report published Friday, Canaccord Genuity analyst Mark Massaro maintained a Buy rating on EXACT Sciences Corporation
, with a price target of $32, following the company's Analyst Day.
EXACT Sciences pre-announced Q2 completed tests of 21K, ahead of Canaccord Genuity's forecast of 18,662. The company also recorded a patient compliance rate of 73 percent, above the 71 percent estimate. "The company's recent use of $10 gift cards (introduced a few weeks ago) as incentives could help lift compliance above 73%." analyst Mark Massaro said.
In the report Canaccord Genuity noted, "We came away with a greater appreciation for the company's access to talent, particularly the Mayo Clinic and Dr. David Ahlquist, whose presentation on the pancreatic test stood out to us given the test's data in the 90s. While it's too early for EXAS to determine a regulatory pathway, we are encouraged it may choose to launch a lab-developed test (LDT) for pancreatic cancer, which would allow EXAS to hit the market as early as 2017 (our initial estimate) and add another source of revenue besides Cologuard."
Having toured EXACT Sciences' 30K-sq.-foot lab, Mark Massaro wrote that it was a "solid operation" and that the company has the space "to scale its capacity beyond 1M tests, if needed."
The revenue estimate for Q2 has been raised from $7.7M to $8.6M, to reflect the Q2 volume guidance. The EPS estimates for 2015 and 2016 have been reduced from $(1.55) to $(1.63) and from $(0.99) to $(1.09), respectively, to reflect higher S&M spend.
What I like, as far as Exact Sciences, is seeing MD Andersen's name in there.
Exact Sciences today forecast 21,000 completed Cologuard tests for the second quarter.
The Madison, Wisconsin-based molecular diagnostics firm beat its earlier expectation of 18,000 tests for Q2. It also said today that it anticipates about 32,000 completed Cologuard tests for the third quarter.
The US Food and Drug Administration approved the non-invasive stool DNA-based colon cancer screening test last August, and in October the Centers for Medicare and Medicaid Services issued a final national coverage determination for the test. The CE-marked test is also available in parts of Europe.
Exact Sciences said that since Cologuard's launch in October, more than 13,800 doctors have ordered the test at least once. It added that the patient compliance rate — defined as the number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to June 19 — has risen to 73 percent.
"The launch of Cologuard remains very strong and we continue to invest in its growth," Exact Sciences Chairman and CEO Kevin Conroy said in a statement. "We also are pleased with the level of patient compliance, as it confirms that Cologuard is expanding the pool of those who get screened."
In early Thursday trade on the Nasdaq, shares of exact Sciences were up 5 percent at $32.76.
Is the way it is slowly creeps up. Giving the shorts a false sense of hope. Slowly eroding their investment. They have no clue that eventually EXAS will explode and a true short squeeze will destroy them.!!!
With just a drop of blood doctors may one day be able to detect pancreatic cancer in its early stages, before it has become deadly, a new study suggests.
An international team of researchers was able to identify 100 percent of patients with late-stage pancreatic cancer, as well as those with earlier stage disease, by looking for a protein in the blood that is made in abundance by tumor cells.
That protein turns up in tiny virus-sized particles, called exosomes, which are excreted by all of the body's cells, according to the study published in Nature. But, by good fortune, the protein turns up in exosomes only when there is cancer, so its presence could be an early, and testable, marker for the disease.
It's rare to discover pancreatic cancer early, said study coauthor Dr. Raghu Kalluri, professor and chairman of the department of cancer biology at the MD Anderson Cancer Center. "People don't feel any symptoms that make them want to go to the clinic until their cancer is stage 3 or stage 4," he added. "Using this test we were 100 percent accurate at identifying all cancer patients."
In 2015 48,960 Americans will be diagnosed with pancreatic cancer, according to estimates by the National Cancer Institute. And an estimated 40,560 will die from the disease. It is the most deadly cancer with just 7.2 percent surviving five years.
For perspective, over the course of a lifetime, 1.5 percent of Americans will develop pancreatic cancer.
While quite promising, the new findings will need to be verified and validated by other studies, experts told NBC News. And even if it passes muster, it will take some time before a test could be developed to screen for the disease.
Kalluri and his colleagues examined serum samples from 190 patients with pancreatic cancer, 32 patients with breast cancer and 100 healthy volunteers. They found levels of the protein in exosomes correlated with the severity of the disease — so there was more in patients with more advanced disease. It was not present in the healthy volunteers.
Even more promising are the findings from the seven patients with early pancreatic cancer that were detectable through their protein levels. Further, levels dropped when patients had surgery to remove their tumors, so the marker could also be used to follow the progression of the disease, Kalluri said.
Kalluri says that a screening test might be available in as little as a year. But, he said, "this is just a speculation based on the current strength of the study."
Had such a test been available, it might have save the life of Dr. Teresa Flippo-Morton, a prominent breast surgeon from Charlotte, N.C.
"She was an expert in oncology," said Dr. Derek Raghavan, a colleague and president of the Levine Cancer Institute where Flippo-Morton worked. "She did all the things you are supposed to do. She wasn't a smoker. She lived a healthy lifestyle. She had a good work-life balance. She exercised. She took vacations. It is a good example of how this disease sneaks up on people and gives no warning."
A test for pancreatic cancer could save lives, perhaps even Flippo-Morton's, Raghavan said.
"If this study is confirmed, this will make a difference because it's one of the cancers we don't have any reliable screening test for," he added. "It kills people and it kills them quickly."
A screening test could have a huge effect, said Dr. Timothy Donahue, an associate professor of surgery and molecular and medical pharmacology and chief of pancreas and gastrointestinal surgery at the University of California, Los Angeles.
"Pancreatic cancer is the fourth leading cause of cancer death in this country and it's predicted, if the current prevalence and survival rate continues, that it will become number two within the next five to 10 years," Donahue said. "Something like this could potentially flatten that curve and change the epidemiology of pancreatic cancer."
Still, Donahue said, the method needs to be "heavily vetted and validated. But it's as good of an academic start as I've ever seen. It now needs to be taken over by some diagnostic corporation before it can launch into something for widespread use."
What needs to be determined is "what the sensitivity and specificity would be in a screening population of 100,000 people," said Dr. Brian Wolpin, of the Dana Farber Cancer Institute. "In this study the patients were known to have cancer or not to have cancer. In this kind of sample sensitivity and specificity tend to look good."
I am all signed up for Investor Day online.
Wish I was there
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it expects to end the second quarter of 2015 with approximately 21,000 completed Cologuard tests.
More than 13,800 physicians ordered at least one Cologuard test since the October 2014 launch and the patient compliance rate for Cologuard rose to 73 percent.
The company anticipates completing approximately 32,000 tests during the third quarter of 2015.
“The launch of Cologuard remains very strong and we continue to invest in its growth,” said Kevin T. Conroy, chairman and chief executive officer of Exact Sciences. “We also are pleased with the level of patient compliance, as it confirms that Cologuard is expanding the pool of those who get screened.”
The U.S. Food and Drug Administration (FDA) approved Cologuard, a noninvasive stool-DNA based colon cancer screening test for average-risk patients, on August 11, 2014, and a final national coverage determination for Cologuard was announced by the Centers for Medicare and Medicaid Services (CMS) on October 9, 2014. Cologuard is CE marked and available in parts of the EU.
Exact Sciences will report second-quarter 2015 financial results and provide a commercial update during its earnings call in July 2015. The patient compliance rate is derived from the number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to June 19, 2015.
I didn't know that Exact Sciences Lab had worked out all the kinks and now advertise that results are uploaded to portal within 2 weeks of sample receipt.
Expansion plans for Madison's Exact Sciences
The company is working to expand its at-home colorectal cancer screening test called Cologuard to Europe.
Right now, it's been introduced in London.
listen to interview
Madison’s Exact Sciences has generated a lot of buzz lately, with a colon cancer screening test that could save millions of lives and make millions of dollars. The company is also looking for a subsidy from the city to locate its headquarters downtown. But as Joe Tarr reported in last week’s Isthmus, the company is not without risk. He spoke with WORT-FM producer Dylan Brogan about the story for In Our Backyard, the station’s evening news program..
Don't shoot messenger I am just posting stupid people
Raise your hand if you can't wait to have a colonoscopy.
Raise your hand if you can't wait to have a colonoscopy.
Didn't think so.
It all starts with what doctors like to call bowel "prep" as if were as benign as getting ready for the SATs or cutting up veggies for a stir fry. But there's no glossing over the almost absurd 24 hours of drinking fluids, downing laxatives and racing to the bathroom — again and again and again. Then, on the day of the procedure, you have to miss work, get knocked out and, well, you know the rest.
It's enough to make close to one in three people ages 50 to 75 skip the procedure altogether. And that's terribly unfortunate, especially when colonoscopy is phenomenally successful at early detection of colorectal cancer, which is considered the second leading killer of men and women in the United States and the leading killer among those who don't smoke.
But some doctors in Rhode Island are now ordering a simple new test, called Cologuard, that was just approved last summer by the FDA. All that's required of patients: providing — very naturally — two stool samples.
"The news is, for all of the people out there that refuse to have a colonoscopy, and nobody is going to convince them that they are going to be put to sleep and have a camera put up their rear end, and there are lot of people like that, hey, there is another way," says Jonathan Martin, a physician with Lincoln Primary Care in Lincoln.
"Screening for colorectal cancer is so important. It's one of the most preventable cancers we have," Martin says. "I have people at age 60 or 70 who have never had a colonoscopy. They have just refused. They have never wanted to undergo one ... . Now, I can say how about (Cologuard). You can do it at home."
With Cologuard, patients bring home a kit to collect stool samples, which can then be sent off to a lab for testing. The DNA test can detect the presence of abnormal cells from cancerous and precancerous tumors that have been shed from the colon.
If the results come back positive, patients are then advised to have a colonoscopy.
"We've screened people who refused colonoscopy," said Martin, and "we do find positive results. If it's positive, you can say, 'Look, you need to undergo a colonoscopy.' Hopefully you are catching these things at an early stage."
Studies have found that Cologuard detected colorectal cancer 92 percent of the time and 94 percent for the earliest and most curable cancer stages. That's comparable to colonoscopy. Another type of stool test, which examines traces of blood and is known as FIT (fecal immunochemical test), detects colorectal cancer about 74 percent overall. False positive results occur about 13 percent of the time for Cologuard versus about 5 percent for FIT.
Dr. Robert Wolfgang, a physician with Gastrointestinal Medicine Associates, with offices in Rhode Island, echoes many of his colleagues when he calls colonoscopy the "gold standard" for preventing and detecting colorectal cancer. But Wolfgang sees value in alternatives, such as Cologuard.
"Any test, especially noninvasive testing including stool DNA testing is applauded for increasing awareness and removing barriers to cancer detection for those not able to undergo other screening methods," Wolfgang said. "The goal is to get a higher percentage of patients screened and attempt to detect and remove polyps at an early stage to prevent cancer."
Wolfgang said that Cologuard is "not a replacement for colonoscopy" particularly since
"it's not great at detecting polyps," which can be both found and removed during colonoscopy.
An important public health goal, Wolfgang said, is decreasing the cost of colorectal screening. Whether trying Cologuard or traditional colonoscopy, patients are likely to have to pay substantial amounts of money out of pocket one way or the other. Those costs can be deterrents to patients seeking good preventive care, he said.
Colonoscopy is typically recommended at age 50 and every 10 years after that, although it's suggested at an earlier age and more frequently for people who are deemed to be at high risk or who have had polyps removed. While it's covered as a preventive measure under all health plans, patients often are still billed hundreds of dollars for anesthesia and, when necessary, the removal of polyps.
Cologuard, meanwhile, is covered for Medicare subscribers. However, at $600 per test, it's not widely covered by private insurers and, even when it is, could be subject to deductibles and other cost-sharing.
Martin has given prescriptions for Cologuard to about 50 patients so far. Of those that returned the kit, two had positive results. One patient has been referred for a colonoscopy while another has already had the procedure done. That patient had six polyps removed, including two that were precancerous.
"We got those out before they turned into anything more serious," Martin said. "Those would have become colon cancer. She will go for a colonoscopy now on a more regular basis."