How's your in-network status treating you?

Quote


anonymous said:
DOJ is insignificant - the fact that Panorama isn't being reimbursed for FISH probes, 10-20k, is a larger concern. Good luck making up profits when being paid 800$ by insurance, rather than 10Xs that.
Click to expand...

"Our goal is not to keep growing revenues but to make the world a better place"

Dr. Matthew Rabinowitz
 
Exciting times!

Natera, Inc. Announces Launch of Vistara Single-Gene Mutation NIPT
A NIPT to screen for single gene disorders using cfDNA
SAN CARLOS, Calif., May 8, 2017 /PRNewswire/ -- Natera (NASDAQ: NTRA), a leader in genetic testing, announced the launch of Vistara, a non-invasive prenatal test (NIPT) to screen single-gene disorders. Vistara is a complement to Natera's market-leading Panorama® non-invasive prenatal test (NIPT) and screens for new mutations in 30 genes that have a combined incidence rate of nearly 1 in 600, which is higher than that of Down syndrome.1, 2 These mutations can cause severe conditions that affect skeletal, cardiac, and neurological systems, and often go undetected with routine prenatal screening. Natera will offer Vistara through its leading direct sales channel in the United States.

Natera has partnered with Baylor Genetics to commercialize Vistara and is initially launching the test to Maternal Fetal Medicine specialists (MFMs) at leading clinics throughout the U.S., and broadly to Obstetrician-Gynecologists (OBGYNs) at a later date, after market education and support. Vistara expands Natera's existing portfolio of women's reproductive health products and will also be well positioned to immediately take advantage of Natera's well-established commercial capabilities, including patient and healthcare provider digital services through Natera's Patient Portal and Natera Connect, and a specialized salesforce that already calls on the nation's busiest MFMs and OBGYNs.

"Screening for single-gene disorders early in pregnancy can be extremely helpful and is an important next step in the ability to screen for fetuses with major anatomic abnormalities and chromosome imbalances," said Dr. Brian Krishon, a Maternal Fetal Medicine specialist at Houston Perinatal Associates. "As just one example, prenatal screening with confirmatory diagnostic testing for osteogenesis imperfecta (OI) can result in reduced bone fractures through adjusted delivery and post-natal management."

"This is a paradigm shift in prenatal screening. This technology screens for new mutations that are common and cannot be detected by standard carrier screening, as these mutations are not present on the parents," said Matt Rabinowitz, CEO and founder of Natera. "Our expansion into screening for single-gene mutations builds on the success of Panorama, the market-leading NIPT for common trisomies and microdeletions, and furthers Natera's mission to transform the diagnosis and management of genetic diseases."

Addressing an Unmet Clinical Need
Vistara screens for common single-gene disorders such as Noonan syndrome, osteogenesis imperfecta, craniosynostosis syndromes, achondroplasia, and Rett syndrome. Noonan syndrome, for example, has non-specific ultrasound findings and may not be detected prenatally without single-gene testing. Noonan syndrome is characterized by short stature, cardiac defects, bleeding problems and mild intellectual disabilities in some cases. It affects 1 in 1,000 to 1 in 2,500 births.

The incidence of the diseases screened by Vistara is higher than that of cystic fibrosis, which is commonly screened by OBGYNs and is well reimbursed. In addition, these conditions are not screened with existing NIPTs. Ultrasound exams may either completely miss these disorders or identify non-specific findings late (2nd or 3rd trimester) in the pregnancy. Further, family history is not a good indicator of risk for these conditions, which are commonly caused by de novo (not inherited) mutations. Vistara has a combined analytical sensitivity of >99% and a combined analytical specificity of >99% in validation studies.3 Given the combined high incidence of these disorders, Vistara may be used to screen all singleton pregnancies after nine weeks gestation.4 A positive screen result from Vistara will direct the clinician to order the appropriate diagnostic tests, and upon confirmation, guide labor and delivery management, and channel patients to necessary specialists.
 
anonymous said:
"Screening for single-gene disorders early in pregnancy can be extremely helpful and is an important next step in the ability to screen for fetuses with major anatomic abnormalities and chromosome imbalances," said Dr. Brian Krishon, a Maternal Fetal Medicine specialist at Houston Perinatal Associates.
Click to expand...

Who is Dr. Brian Krishon? I can't find any details on him on a Google search.
 
anonymous said:
What's this about a DOJ investigation?
Click to expand...

from a press release on may 4,

"Natera Announces the Appointment of Gail Marcus as Member of the Board of Directors"

this is the same gail marcus who was president and ceo of calloway laboratories, starting on September 25, 2012 (http://www.prnewswire.com/news-releases/ampersand-to-acquire-calloway-laboratories-171206741.html).

this is the same calloway laboratories that was involved in fraudulent billing (https://www.justice.gov/usao-sdwv/p...-record-breaking-health-care-fraud-settlement).

and this is the same calloway laboratories that shut down in 2015 (http://www.masslive.com/news/boston/index.ssf/2015/10/calloway_labs_closes_its_doors.html).

she's got the magic touch!
 
Aetna Won't Cover Noninvasive Prenatal Testing for Average-Risk Pregnancies
Jul 14, 2017 | staff reporter
NEW YORK (GenomeWeb) – Aetna updated its medical policy for noninvasive prenatal testing this week, choosing not to cover screening for average-risk pregnancies. It will continue to cover NIPT for high-risk pregnancies.

In a research note published by investment bank Piper Jaffray, Senior Research Analyst William Quirk wrote that the "decision by Aetna is disappointing." The payor covers around 17.9 million lives.

The decision will impact all NIPT providers, but may particularly impact Natera, which has targeted its NIPT, Panorama, especially to the average-risk pregnancy market and has seen sales of its test in that market grow.

How will this affect our stock price?
 
anonymous said:
DOJ is insignificant - the fact that Panorama isn't being reimbursed for FISH probes, 10-20k, is a larger concern. Good luck making up profits when being paid 800$ by insurance, rather than 10Xs that.
Click to expand...

DOJ is significant - see below:
California Genetic Testing Service Pays $11 Million To Resolve False Claims Allegations
Allegedly submitted fraudulent medical claims for reimbursement

Will Pay $10,635,615.90 as part of Federal Settlement and $756,183 to a Number of States

LOUISVILLE, Ky. – United States Attorney Russell M. Coleman, acting on behalf of the Office of Inspector General of the Department of Health and Human Services, the TRICARE Program, and the Federal Employees Health Benefits Program (FEHB) today announced a $10,635,615.90 settlement with Natera, Inc., to resolve claims that Natera improperly billed federal healthcare programs for Natera’s non-invasive prenatal test known as Panorama®. Natera has also agreed to pay an additional $756,183 to a number of state Medicaid programs.

"Let this hefty settlement send a message that pursuing healthcare fraud is a priority of our Office and of the Department of Justice” stated United States Attorney Russell Coleman. “Overbilling federal healthcare programs steals from taxpayers and drives up the cost of healthcare for us all. Recovering taxpayer dollars lost to fraud helps keep strong those critical public healthcare programs so many Kentucky families depend on.”

"I applaud the Department of Justice and the U.S. Attorney for their untiring efforts to hold health care providers accountable to the American taxpayer," said Vice Adm. Raquel Bono, director of the Defense Health Agency, which manages the TRICARE Health Plan. "The Department of Justice's efforts safeguard the TRICARE benefit for American service members, veterans and their families. The Defense Health Agency continues to work closely with the Justice Department, and other state and federal agencies to investigate all those who participated in fraudulent practices."

“In concert with our investigative partners, DCIS aggressively pursues fraud and corruption that undermines the integrity of Department of Defense programs, especially those involving the well-being of our Warfighters who deserve the best medical care available,” stated John F. Khin, DOD-DCIS Special Agent in Charge. “It is unconscionable for a health care provider to make profits by taking advantage of military members and their families when they are most vulnerable.”

“Today’s settlement shows the OPM-OIG’s commitment to investigating and prosecuting fraudulent billing practices that waste taxpayer dollars, increase the cost of medical care, and undermine the integrity of the Federal Employees Health Benefits Program. I would like to thank the United States Attorney’s Office and our law enforcement partners for all their hard work,” stated Scott Rezendes, OPM-OIG Special Agent in Charge.

The United States contended that between January 1, 2013, through December 31, 2016, Natera knowingly submitted false or fraudulent claims seeking payment from the TRICARE Program, FEHB, and Medicaid program for Natera’s genetic testing services, including its non-invasive prenatal test known as Panorama® (including optional panels that screened for microdeletion syndromes).

Specifically, the United States contended that for dates of service between January 1, 2013, through March 4, 2015, Natera improperly billed TRICARE for its Panorama® test, (including optional panels that screened for microdeletion syndromes), when TRICARE did not reimburse for certain laboratory developed test. Further, during dates of service between January 1, 2013, through December 31, 2016, Natera improperly billed TRICARE for non-invasive prenatal screening of certain microdeletion syndromes when TRICARE did not reimburse for this screening. During the same period, Natera improperly billed TRICARE, FEHBP, and Medicaid for its Panorama® test and for its non-invasive prenatal screening of certain microdeletion syndromes, by using an improper code which misrepresented the services Natera was billing to these programs. Lastly, during the same dates of service, Natera billed TRICARE, FEHBP, and Medicaid for its Panorama® test (including optional panels that screened for microdeletion syndromes) for patients with low-risk pregnancies. Natera denies this allegation.

This matter arose as a complaint for monetary damages under the qui tam provisions of the federal False Claims Act. The relators, Sallie McAdoo and Steven Aldridge, filed a qui tam action on January 26, 2015, in United States District Court for the Western District of Kentucky (United States, ex rel. Sallie McAdoo and Steven Aldridge v. Natera, Inc., Civil Action No. 3:15-cv-88-DJH).

Natera is entering into a separate settlement agreement in the amount of $756,183.00 (the “Medicaid State Settlement Agreements”) for similar conduct related to various state Medicaid programs. The Medicaid State Settlement Agreement was negotiated by a team with the National Association of Medicaid Fraud Control Units.

The matter was handled by Assistant United States Attorney Benjamin S. Schecter, of the U.S. Attorney’s Office for the Western District of Kentucky. The investigation was conducted by the Department of Defense, Office of the Inspector General, Defense Criminal Investigative Services (DCIS) and the Defense Health Agency (DHA).

Link to press release: https://www.justice.gov/usao-wdky/p...s-11-million-resolve-false-claims-allegations
Link to settlement agreement: https://www.justice.gov/usao-wdky/press-release/file/1042441/download
 
anonymous said:
Sounds like more lawsuits are coming!
Click to expand...

Yes, you're right. Illumina is joining the party now.

Illumina Sues Natera Over NIPT Library Prep Patent
Mar 19, 2018
|
staff reporter
NEW YORK (GenomeWeb) – Illumina has filed a lawsuit against Natera, alleging that the company's non-invasive prenatal testing infringes its US Patent No. 9,493,831, which covers methods for library preparation.

Natera began selling its commercial noninvasive prenatal test Panorama in 2013, which relies on analysis of cell-free DNA present in maternal blood using a multiplex targeted PCR approach.

In its lawsuit filed on March 16 in US District Court, Northern District of California, San Francisco Division, Illumina is claiming that in offering and performing Panorama, Natera infringes "literally or under the doctrine of equivalents" claims 1-3, 6-10, 13-22, and 24 of the ’831 patent.

The company also asserts that Natera has infringed the patent willfully and deliberately, at least since December 2016 when Illumina sent the firm a letter to that end.

In an email, a Natera spokesperson said that the new lawsuit is not a surprise.

"We had anticipated that Illumina might file this suit in response to last week’s announcement of our deal with Qiagen. Based on … our knowledge of Illumina’s patents, we feel comfortable that we will prevail in any patent suit with Illumina should it proceed," the firm wrote.

Natera and Qiagen have signed a 10-year agreement to develop cell-free DNA assays for use on Qiagen's GeneReader next-generation sequencing system, for the purposes of prenatal screening.

Natera said that it plans to continue to rely on Illumina products so far as the costs and services remain competitive for its lab. "Our 10-year supply agreement with Illumina does not expire until 2026, and we do not expect this to disrupt our operations," the company wrote.

The NIPT space has been litigious for several years. This January, for example, Illumina won another patent infringement suit against Roche's Ariosa Diagnostics. That suit concerned two patents originally held by Verinata Health, which Illumina acquired in 2013: US Patent No. 8,318,430 and US Patent No. 7,955,794.
 
anonymous said:
“First they think you’re crazy, then they fight you and then all of a sudden you change the world.”

Elizabeth Holmes
Click to expand...

“The Theranos story is an important lesson for Silicon Valley. Innovators who seek to revolutionize and disrupt an industry must tell investors the truth about what their technology can do today, not just what they hope it might do someday.”

Jina Choi, SEC Regional Director
 
anonymous said:
“The Theranos story is an important lesson for Silicon Valley. Innovators who seek to revolutionize and disrupt an industry must tell investors the truth about what their technology can do today, not just what they hope it might do someday.”

Jina Choi, SEC Regional Director
Click to expand...

"This district, led by Silicon Valley, is at the center of modern technological innovation and entrepreneurial spirit; capital investment makes that possible. Investors large and small from around the world are attracted to Silicon Valley by its track record, its talent, and its promise. They are also attracted by the fact that behind the innovation and entrepreneurship are rules of law that require honesty, fair play, and transparency. This office, along with our other law enforcement partners in the Bay Area, will vigorously investigate and prosecute those who do not play by the rules that make Silicon Valley work."

Acting United States Attorney Alex G. Tse
 
anonymous said:
"This district, led by Silicon Valley, is at the center of modern technological innovation and entrepreneurial spirit; capital investment makes that possible. Investors large and small from around the world are attracted to Silicon Valley by its track record, its talent, and its promise. They are also attracted by the fact that behind the innovation and entrepreneurship are rules of law that require honesty, fair play, and transparency. This office, along with our other law enforcement partners in the Bay Area, will vigorously investigate and prosecute those who do not play by the rules that make Silicon Valley work."

Acting United States Attorney Alex G. Tse
Click to expand...

"Better off working at Theranos

You are asked to lie to auditors that the CLS supervises your work
CLS are told to sign off on things the do not approve of and would be unacceptable in a certified lab
Constantly need to watch your back because your profession is on the line (like working for an illegitimate company, doing things you aren't trained/certified to do so)
Was told I would be fired if I spoke about my pay (Illegal)"

Anonymous Glassdoor review, November 10, 2016

 
anonymous said:
"Better off working at Theranos

You are asked to lie to auditors that the CLS supervises your work
CLS are told to sign off on things the do not approve of and would be unacceptable in a certified lab
Constantly need to watch your back because your profession is on the line (like working for an illegitimate company, doing things you aren't trained/certified to do so)
Was told I would be fired if I spoke about my pay (Illegal)"

Anonymous Glassdoor review, November 10, 2016
Click to expand...
3 Lessons Investors Can Learn from Theranos' Implosion
Frauds aren't going away. Here are three ways to avoid them.
1. Culture matters
When a company is perpetrating a fraud, there are bound to be employees with misgivings.
That's why I frequently use Glassdoor.com as a data point in my own stock-picking process. The site allows anyone to submit an anonymous review about a company they work for. It then tabulates all of the reviews and offers up an overall score (from one to five stars).
As you might expect, the tool isn't perfect. Human resources departments can get employees to submit doctored reviews, and short-sellers can contribute nefarious reports without a shred of evidence. That's why it's important to go beyond the numbers and actually read the reviews. Over time, you can get a feel for what's a genuine review, and what is meaningless spam. And in the end, this is a data point, not the data point.
My own investment decisions have been informed greatly by some of what I found on the site. For example, I once backed away from an investment in a bank based, in part, on what I read on Glassdoor. A few months later, a suit was brought by a former employee against the company and the stock cratered.
Anyone who checked out Theranos' Glassdoor ratings before the first Wall Street Journal report would have found several red flags. Carreyrou even highlights one in the book that sent Theranos's COO at the time into a tirade:
How to make money at Theranos:
Lie to venture capitalists
Lie to doctors, patients, FDA [Food and Drug Administration], CDC [Centers for Disease Control], government. While also committing highly unethical and immoral (and possibly illegal) acts.

Brian Stoffel, The Motley Fool. June 26, 2018
 


Write your reply...
Top Bottom
Back
Quote