22 Şubat 2013 Cuma

Silicon Is Back, FDA Approves New and Updated Breast Implants from Allergan With Conditions

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imageSilicon breast implants have been approved for quite a few years and now there’s a new and improved model.  I was looking at the website and looks like there’s a sale with the opportunity to get a free Botox treatment and a Latisse prescription trial for longer eyelashes too.  You can read the conditions below and basically the FDA is calling for follow up and information for at least 5 years.  BD


The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.

The FDA based its approval on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.  In addition, investigators observed fissures (cracks) in the gel of some Natrelle 410 implants.  This is a characteristic called gel fracture and is unique to this implant.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

As a condition of approval for the Natrelle 410 breast implants, Allergan must:

  • Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study;
  • Conduct a 10-year study of more than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications); 
  • Conduct five case control studies to evaluate the possible association between the Natrelle 410 implants, as well as other silicone gel-filled breast implants, and five rare diseases—rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
  • Evaluate women’s perceptions of the patient labeling; and
  • Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340447.htm

Mike Pence of Indiana Wants to Be Governor “Ultra-Sound Number Two”– Wants 2 Ultra-Sounds, Before and After the Taking Abortion Pill…Digital Illiteracy Keeps Enacting Vaginal Legislative Discussions

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imageWhy don’t they just give this up?  When I see this I loudly think “digital illiteracy” as they don’t know what  to do and they go off into areas of insanity like this.  I do like the nick name “Governor UltraSound” as this fits.  I mean I can’t for the life of me understand why adult men are so into this topic and can’t leave abortions alone.  This is is so ridiculous I can’t even laugh!  

Digital Illiteracy Still Plagues Law Makers–Severe Focus on Abortion Rights Proves It–Is This Where Our Lawmaking Knowledge Leaves Off or Even Begins? Scary…

We have financial worries up the ying yang and this is all they can talk about. Here’s one more from last year. I mean don’t these men care or even think about how people view them? We want some intelligence out there not a redo of the Roman Empire. image
Maybe this is an age thing right?  You never see any men under 50 or so disturbed about this:)  Is this some form of mental illness or passive aggressive behavior?  When this came up again I mean you really have to laugh at trying to control vaginas.  Rachel Maddow does a good job with this too.  I don’t care what party one is but to carry on like this is so stupid and those folks were elected to make laws and this is not a law, it’s just plain stupid.  Look at the screenshot below and hold on to your hat…digital illiteracy with some just can’t get there and the vaginal focus just won’t quit.  BD 

 

Visit NBCNews.com for breaking news, world news, and news about the economy



image

Here We Go Again–Digital Illiteracy With Lawmakers & Those Running for Office–Back to the “Default” Topic of Women’s Health With A Need to Control Something When the Intellect Is Not There…Akin


http://video.msnbc.msn.com/the-rachel-maddow-show/50899358/#50899424

150 Federal and State Agents Raid the Scooter Store in Texas Suspecting Medicare Fraud Billing

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Yes who has not heard of the Scooter Store as their TV ads are everywhere.  According to the video the agencies had some information from former employees.  The Inspector General imagestated that 80% of power chairs were paid for in error, going to people who don’t need them.  $108 Million dollars is the amount stated in question.  One former employee stated they ranked doctors and has a persistent marketing format that “wore doctors down”.  This one will be interesting to follow.  150 Agents, that’s a lot of people to to seize the evidence.  Nobody has been arrested and no charges have been filed.  You can see the boxes of evidence being carried out.  The company did send back  $19 million to Medicare last year, and that sound like a lot of chairs.  BD





On Wednesday, 150 federal and state agents raided The SCOOTER Store headquarters in New Braunfels, Texas, and agents remain on the site. CBS News just spoke to an FBI agent Thursday morning who said workers will not be allowed back into headquarters through the day as the nation's largest power wheelchair company remains under investigation.

Late last year, former employees told CBS News the company's main goal is not to help patients -- it's to bulldoze doctors into writing prescriptions to boost profits. Former SCOOTER Store employee Brian Setzer said, "Bulldoze and get them to get the paperwork done."

The issue is that once a doctor has written a prescription, Medicare rarely verifies whether the chairs are actually necessary. The problem was crystallized when the Inspector General of the Department of Health and Human Services released this report, finding that industry-wide, 80 percent of Medicare payments for power chairs are made in error, most going to people who don't need them, or who lack proof they need them.

http://www.cbsnews.com/8301-505266_162-57570450/the-scooter-store-power-wheelchair-company-raided-in-federal-probe/

UCLA Improves the Study of Single Cancer Cells Of Blood From Tumors & Those Circulating

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The nanowires grab the cancer cells flowing through and they can hand pick cells for study as relates to Melanoma. The goal is to have a clinically applicable liquid biopsy.  BD

Press Release:

UCLA RESEARCHERS FURTHER IMPROVE ‘NANOVELCRO’ DEVICE TO

ISOLATE AND STUDY SINGLE CANCER CELLS FROM BLOOD


Researchers at UCLA have further improved a method for capturing and analyzing cancer cells that break away from patients’ tumors and circulate in the blood. imageWith the improvements, even single cancer cells can be accurately detected and safely isolated from patient blood samples for continuous analysis.

These cells, called circulating tumor cells (CTCs), metastasize or spread from one tumor to other parts of the body and form new tumors, thus propagating cancer in the patient. When they are isolated from the patient’s blood early over the course of disease progression, they can provide doctors with critical information about the type of cancer, the characteristics of the individual cancer, and its possible progression. Doctors can also tell from these cells how to tailor a personalized treatment approach for a specific patient. 

In recent years, a UCLA research team led by Hsian-Rong Tseng, associate professor of molecular and medical pharmacology at the Crump Institute for Molecular Imaging and a member of the California NanoSystems Institute and the Jonsson Comprehensive Cancer Center (JCCC) has developed a “NanoVelcro” chip. Blood is passed through the chip, in which very small nanoscale hairs (nanowires or nanofibers) coated with protein molecules from the immune system (antibodies) that match proteins on the surface of cancer cells trap CTCs and isolate them for further studies.

The CTCs trapped by the chip also act as a “liquid biopsy” of the tumor, providing convenient access to tumor cells, and earlier access to potentially fatal metastases. This study of the microscopic structure of diseased tissue is called histopathology analysis of biopsy samples and is considered the “gold standard” for determining tumor status. Being able to extract viable cells allows detailed analysis of the type of cancer, and the various genetic characteristics of that patient’s specific cancer.

Tseng’s team has now improved the chip by replacing the original non-transparent silicon nanowire substrate inside the device. These nanowires grab the cancer cells as the blood passes by them. Using a new type of transparent polymer nanofiber-deposited substrate, Tseng and his colleagues were able to “pick” single CTCs immobilized on the transparent substrates by using a miniaturized laser beam knife, a technique called laser microdissection (LMD). An article on the improvement of the chip was published online today, and is featured on the cover of the March 2013 issue of the peer-reviewed journal Angewandte Chemie,

“This paper summarizes a major milestone in the continuous development of NanoVelcro assays pioneered by our research group,” said Tseng, “we now can not only capture cancer cells from blood with high efficiency, but also hand pick single CTCs for in-depth characterization to provide crucial information that helps doctors make better decisions.”

Using the new assay on patients’ blood that contained circulating melanoma cells (CMCs), Tseng’s team was able to isolate and preserve single CMCs. Melanoma is a deadly type of skin cancer that is prone to spreading quickly throughout the body. The ability to capture and preserve single CMCs allows doctors to analyze the DNA structure of the cells and determine genetic characteristics of the patient’s cancer, confirming that the circulating cells remained genetically similar to the tumor they came from.

The preservation of single captured CMCs in the proof-of-concept study also allowed researchers to conduct an analysis, called single-cell genotyping, to find within the cell a specific target (BRAFV600E) for a drug called vemurafenib. This designation describes a mutation in a protein called BRAF that appears in approximately 60 percent of melanoma cases. Drugs that inhibit BRAF are able to slow and often reverse the growth of melanoma tumors.

“With this technology we are getting closer to the goal of a widely clinically applicable liquid biopsy, where we can sample cancer cells by a simple blood draw and understand the genes that allow them to grow,” said Dr. Antoni Ribas, professor of medicine in the division of hematology-oncology and JCCC member, and one of Tseng’s key collaborators. “With the NanoVelcro chips we will be able to better personalize the treatments to patients by giving the right treatment to stop what makes that particular cancer grow.”

Dr. Roger Lo, another key Tseng collaborator and an assistant professor in the department of medicine, division of dermatology and department of molecular and medical pharmacology, and JCCC member, added, “This scientific advancement being able to capture the melanoma cells in transit in the blood and then perform genetic analysis on them will in principle allow us to track the genomic evolution of melanoma under BRAF inhibitor therapy and understand better the development of drug resistance.”

UCLA's Jonsson Comprehensive Cancer Center has more than 240 researchers and clinicians engaged in disease research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson center is dedicated to promoting research and translating basic science into leading-edge clinical studies. In July 2012, the Jonsson Cancer Center was once again named among the nation’s top 10 cancer centers by U.S. News & World Report, a ranking it has held for 12 of the last 13 years. For more information on the Jonsson Cancer Center, visit our website at http://www.cancer.ucla.edu.

Latest From Health Insurance Business Intelligence Analytics For Avoiding Risk and Saving Money, Break Up Marriages and Dump the Spouse Coverage

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Surcharge are becoming more well known for spouses and when the numbers are crunched, risk assessments are performed along with any other type of risk numbers such as mortality rates, etc. and the results must be saying “dump the spouse” according to this article in Market Watch.  This is pretty much talking about employer provided insurance.  There are people out there that marry for this, well almost but it certainly is a big consideration, and maybe they really do.  A couple years ago we had this story on the web.

Will Marry For Health Insurance Web Site – Nobody Cares, Responds, The Reality of A 30 Second Attention Span

Some companies have policies that discourage spouses and some just make it too expensive to add them.  The problem too is that some individuals can’t get insurance otherwise.  The surcharges can be as much imageas $100 a month and depending on income that can be a big issue or an inconvenience.  In 2014 we shall how this works as there will be exchanges for spouses to get insurance outside the company with the next provisions of the healthcare reform kick in.  Some companies will only allow the spouse added on if they already have their own insurance.  If plans are different and cover different doctors then both can’t see the same doctor.  Risk assessments and costs are working on all budgets today.  In some cases with Medicaid as this link below states, people get divorced to get coverage and it all comes back to income and how the numbers work out.  This sure doesn’t do much for keep the American tradition of family together.  BD

Divorce for Medicaid and Marry for Insurance – The American Healthcare System


By denying coverage to spouses, employers not only save the annual premiums, but also the new fees that went into effect as part of the Affordable Care Act. This year, companies have to pay $1 or $2 “per life” covered on their plans, a sum that jumps to $65 in 2014. And health law guidelines proposed recently mandate coverage of employees’ dependent children (up to age 26), but husbands and wives are optional. “The question about whether it’s obligatory to cover the family of the employee is being thought through more than ever before,” says Helen Darling, president of the National Business Group on Health

Such exclusions barely existed three years ago, but experts expect an increasing number of employers to adopt them: “That’s the next step,” Darling says. HMS, a company that audits plans for employers, estimates that nearly a third of companies might have such policies now. Holdouts say they feel under pressure to follow suit. “We’re the last domino,” says Duke Bennett, mayor of Terre Haute, Ind., which is instituting a spousal carve-out for the city’s health plan, effective July 2013, after nearly all major employers in the area dropped spouses.

About a fifth of companies had policies to discourage spouses from joining their health plan in 2012, according to Mercer, though most just charged extra—$100 a month, on average—to cover spouses who could get insurance elsewhere, rather than deny coverage entirely. Indeed, large firms including generics maker Teva and supply chain manager Intermec have spousal surcharges costing $100 a month, or $1,200 annually, while Xerox charges $1,000 for the year

Some companies drive spouses away using other tactics, such as making spousal coverage prohibitively expensive through higher surcharges or by making reimbursement rates so low that spouses can’t afford the plans.

http://www.marketwatch.com/story/why-your-boss-is-dumping-your-wife-2013-02-22?link=sfmw

21 Şubat 2013 Perşembe

Tri-West (Tri-Care Contract) Healthcare Begins Switching Members & Services To United Healthcare, The Contract Awarded After the Insurer Sued the Department of Defense

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The transition has begun and the former Blue Cross subsidiary who tried to hang on and the that members of Tri-Care wanted to keep is slowly going out of business as the loss was too big for them to sustain.  If you followed the couple of years of Tri-Care updates, and it was a long one, United wanted the south too until Humana protested the award and got it back so that only left the west and when they didn’t get it, the company sued DOD to get it.  This contract was worth around $20 billion so to the court they went to get their money to manage care.  I think they make more from all their subsidiaries be it their bank, wellness, analytics, EHR companies etc than they do selling policies. 

Update: UnitedHealthcare Sues Department of Defense Over Tri-Care Contracts–They Said They Would Do This – Is This A Case Of My Algorithms Are Better Than Yours?

UnitedHealth Loses Tri-Care Protest Again With Contract Awarded to Humana in the South-Now Protesting Contracts Awarded In Both the South and the Western States

Back when it looked like they were going to get the award for the Northeast before the Health Net issued a complaint and got it back, the loss that Health Net was going to incur caused the company to sell of patients and policies in a couple of states back there like Connecticut.  In July of last year Tri-West even took their campaign to the internet but they just could not compete with the business models, algorithms and math formulas that United produced.  That’s how the company makes a lot of money plus selling a lot of your data and if not from the main company, there’s ton of United subsidiaries that sell tons of data.  I wonder how much they make selling data as if Walgreens can make short of $800 million selling data alone in 2010, these folks have to be up around 2 or 3 billion in profits selling data and they were one of the first to make money selling data.  If you were to break down and really look at all the subsidiaries under the United corporate blanket they almost have a company that could handle everything from introducing a drug to the FDA all the way down to physician/hospital reimbursement.  You know they make their money with mathematical formulas and analytics as if you look at job ads at any given time they are always advertising for more “Quants”. If you don’t’ know what those jobs are watch the video on the left and you can learn what Quants do on Wall Street and it’s not much different with companies as they write model and the code. 

 

Tri-West Takes Their Campaign to the Internet Protesting Award of The Award of the Tri-Care Contract to United Healthcare–Savemymilitaryhealthcare.com–Final Decision Date Slated for July 5th

 

So in essence with the data selling and algorithms Blue Cross was pretty much under direct attack here with technology from United.  It’s interesting as to when you read the article, the DOD won’t say why or give a clear answer on why United has the contract. 

“The loss of the contract, which is renewed every five years, was announced last summer. As to why, Celley said the Department of Defense hasn’t given them a clear answer.”

The algorithms probably backed them into a corner somewhere along the line as that’s how they operate as you can remember for 15 years their formulas and algos enabled them to pay doctors and hospitals short for out of network services.  So far it says there won’t be any change in care and patients need not worry, but we didn’t and don’t have the same here in the OC with regular insurance policies since they bought up the large physicians groups.  Crying towels came out in the OC when that happened.  Only half of the employees will get to move over to Untied and the rest will be out of work.  I wonder if they will be bused to a hotel like they did here in the OC. 

UnitedHealthcare Lays Off 180 Employees In Orange County-Initial Notification Sent By Instant Message to Those Affected


April 1st is the actual cut over date and there are 80 locations in the west that are set to be closed down.  Is the word “divest” ever going to come up with this company as they are so big and even have subsidiaries in some areas that compete against themselves in the IT areas.  BD



TriWest Healthcare Alliance's Tricare West medical clinics in Hawaii will transition to UnitedHealth Group after TriWest lost a $17 billion contract renewal with the Department of Defense last year.

“Beginning today, we switched over operations of our various locations on the Islands and also across the Western United States and we will operate on a dual-operations period from now until April 1, at which point UnitedHealth will take over,” TriWest spokesman Scott Celley said. “There are roughly 80 locations across the West today that we are closing down.”

http://www.bizjournals.com/pacific/blog/2013/02/triwest-healthcare-alliances-hawaii.html

Portal for Personalized Wellness Programs, More Data to Scrape and Mine…And One Heck of a Terms of Use Page, Enough to Scare Any Consumer…

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I like software and smart analytics but all these data mining sites trying to get consumers to use and enter data with a dual purpose of defining better health are getting to be a bit much.  You know can we look at the real world here and how consumers think? 

I try to get people involved in their health care and they get mad at me at times, it’s the frustration and I do haveimage to realize that when I am in “internet” land it’s not the same as the “real” world, as to quote Mike Osinski from a video, “you can do anything with software” but it doesn’t’ work in the real world with people all the time.  He’s the one that admitted he wrote the software that “built the bomb that blew up Wall Street” to quote an old New York Magazine article from 2009.   He had no idea as to how his software would be used and abused.   Here’s a couple of quotes from that article and today data mining makes billions in profits and has become an epidemic and stalls job creation with everyone taking an easy road that nobody regulates. 

“I never would have thought, in my most extreme paranoid fantasies, that my software, and the others like it, would have enabled Wall Street to decimate the investments of everyone in my family. Not even the most jaded observer saw that coming. I can’t deny that it allowed a privileged few to exploit the unsuspecting many. But catastrophe, depression, busted banks, forced auctions of entire tracts of houses? The fact that my software, over which I would labor for a decade, facilitated these events is numbing. Is capitalism inherently corrupt?”

“Mike,” he told me when denying my request, “can you really look for people dumber than you and then take advantage of them? That’s what trading is all about.”


Have you ever spoken to the general consumer and tried to help them with some of the information out there, I do. Believe me they do not enjoy entering data and are more and more becoming aware of all the data mining and selling even with lacking the specifics.  Myself I don’t enjoy entering data on websites either for more than I have to.  Let’s look back to this article that I wrote a couple years back for a taste of reality…

What’s On the Agenda Tonight–World of Warcraft or Work on My Personal Health Record


One should acquaint themselves with the Terms of Use page first if you have time as assume this is why they put it out there, that’s enough to make you think you have stumbled on to something that is like “gold” (grin). Just the license to use the site is enough to scare off folks as it contains the usual legal mumbo jumbo of complexities.  We all know about the data mining and selling business and United has been king here for years with their Ingenix division now called Optum and they started with selling your prescription data and it continues on today. 

So again…let’s get to the real world here and is this exciting…probably not to the average consumer and these win-wins are just one more way to potentially collect more data for sale, it’s an epidemic in the US and should be licensed and taxed.  When you get down to it, the people and companies that write this software don’t use it themselves andimage we get back to “its for those guys over there” again.  Commit yourselves as companies to all the technologies you want but there’s not true value in every software program, portal etc. that is created.  BD



UnitedHealthcare and Novu are launching an innovative online portal, www.uhc.novu.com, that enables people enrolled in UnitedHealthcare Medicare Advantage and Prescription Drug plans to create their own health-improvement and wellness programs.

“We believe this easy-to-use online program will empower people to take a more active role in their daily health routines by enabling them to tailor personal wellness programs based on their own unique health needs,” said Tom Wicka, president of Novu. “We partnered with UnitedHealthcare to create this platform because both companies share a commitment to developing innovative technologies that help people improve their health and wellness.”

http://finance.yahoo.com/news/unitedhealthcare-novu-launch-online-portal-133000479.html