FDA Approves First Generic Injection Drug to Prevent Deep Vein Thrombosis

This is good news in the cost department.  As stated below the name brand drug is made from heparin so I am guessing the same active ingredient is present here.  If a blood clot is detected then there are stents that can be put in place in the legs and you can read more at the link below on how this works.  BD

Cook Medical Interview Discussing PAD Leg Therapies– Rob Lyles, VP Peripheral Intervention Division

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.  Approval of generic enoxaparin sodium injection has been granted to Sandoz Inc. of Broomfield, Colorado.

Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.

For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can be more complex for a natural product such as enoxaparin.

“Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said Keith Webber, Ph.D., deputy director of the FDA’s Office of Pharmaceutical Science.

Prior to the approval, the FDA received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection. After carefully reviewing the petition, the agency determined that current scientific evidence, precedent, and FDA's legal authority establish a sound basis for the approval of generic enoxaparin sodium injection. A response to the petition was released by the agency today.

Use of enoxaparin can prevent DVT, a blood clot that forms in a vein deep in the body, especially in the lower leg or thigh. Preventing these blood clots can prevent a pulmonary embolism, which is a sudden, potentially fatal, blockage in a lung artery that can occur if the blood clot breaks free and travels through the bloodstream to the lungs.

FDA Approves First Generic Enoxaparin Sodium Injection to Prevent DVT

Technorati Tags: FDA, deep vein thrombosis, DVT, drugs, injections, healthcare, legs, Sandoz

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A Winning Solution - A Hospital That is Both Green and Wired - Greenwich Hospital in Connecticut

This is a challenge today for hospitals and takes a lot of collaboration from the IT department and administrators.  The IT department crosses over into the overall picture in other areas outside of just the hospital computer and network operations as their input is important for the “green” areas too.  To run and set up the “green” programs, much of this depends on technology and the IT department input is needed. 

I like the pictures here from Jim Weeks from Greenwich Hospital posted on the web of what the server room used to look like and it’s present day appearance.  I think anyone can tell this is a major upgrade here not only in hardware, but functionality too.  I have been in some server rooms where I thought I was close to being electrocuted at times, as there’s a lot of power running through those areas and IT departments all over are doing a good job with reducing power consumption too. 

  

The entire area where the hospital resides had been revamped as you can see from the pictures below.  The lay out of the grounds is so much better organized and you can visibly see “green” on the grounds.  Let’s face it, would you rather walk through a nice flower garden or stand on a big slab of cement?  There’s not much debate there. 

Last year I had the opportunity to tour a brand new wing built by a hospital here in California and I was amazed at how the “green” technology intertwined with not only data but also for the entire hospital.  I learned that even old linoleum could be recycled and used in new flooring!  The Greenwich Hospital made use of an old fountain in part of their work. 

Miller Children’s Hospital Long Beach – Brand New Pavilion Carries Focus on Patients and “Green”

Skylights if designed properly can let in a lot of natural light and it also looks good and saves power consumption.  Building “green” takes an entire committee of it’s own today and the payback is good with not only reducing power consumption, but also gives the facility into a much more soothing appearance, away from the stark white walls we all knew in the past. 

Greenwich Hospital has the honor of being one of the most wired hospitals in the US, so the informational benefits of wireless networks, RFIDs, etc. are there and working to help provide the data and timely tools that leads to better patient care.  Green and wired is where the future lies with all hospitals.  BD 

Years before it was fashionable, Greenwich Hospital was thinking green. In 1996, when we began to revamp our facility, we chose to recycle the existing "brown field site" rather than move to undeveloped land, and when we recently built our Ambulatory Surgery Center on Holly Hill Lane, we renovated according to green standards within an existing facility.

When designing, constructing or operating our facilities, we have adhered to the Leadership in Energy and Environmental Design (LEED) guidelines established by the U.S. Green Buildings Council.

One of the most visible signs of our commitment is the Carl and Dorothy Bennett Community Garden, 2.5 acres of green space that has flower beds, a bluestone terrace, a recycled bronze fountain (salvaged from the 1964 South Wing Terrace) and more than 75 trees. The garden is a huge benefit to our staff, as well as our patients and visitors, who are able to enjoy this open space for relaxation and wellness.

As a result of price negotiations and reductions in natural gas and electricity use, we are cutting energy costs by $800,000 a year. While it's in vogue to adopt green practices, there is also an economic payback.

http://www.greenwichtime.com/default/article/Going-green-in-America-s-hospitals-585925.php

Technorati Tags: Greenwich Hospital, green, recyling, energy, most wired, heatlhcare, hospital, environment, Healtheir Hospitals

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Dozens of Defense Employees Picked Up in Child Porn Sting – Congress /should Rule Against Use of Peer to Peer Networks on Government Employee Computers And Firewall When Personal Computers Connect

Hearing reports like this bothers me as I am sure it bugs others too.  In April we had all the folks at the SEC watching porn too.  Are we not adults to where we need baby sitters at government levels?  It sure sounds like we have some folks who may not be in the adult category.  Over the years I have removed peer to peer software from employee computers and they get mad, go figure.  They think their computer at work belongs to them, to which I say no this is the company computer, yours is at home.  

SEC Staffers Spent A Lot of Time Watching Pornography on Government Computers – Why We Need Data Auditing Algorithms that Run 24/7

So speaking of home computers used for business use, do they not have enough sense to realize that sensitive data can be exposed on the web?

Now this post tells me a lot here in the fact that I don’t think Congress understands peer to peer networks when I read that the Senate wants to put a warning on the computer instead of restricting it, and we might get rid of the porn abusers at the same time by not having it available.  The link below goes to an article from March of 2010 so how slow do we go. 

Breaking News: House Passed a Bill to Prevent Government Employees From Using Peer to Peer File Sharing!

I am just curious as to what methods of reasoning Congress uses when healthcare is grilled to the inth degree for the most part about security, and yet we have all these other folks out there cruising and looking for porn.  Healthcare needs improvement no doubt too but there are some very good CIOs out there doing a real good job with security and it’s not the CIOs of the health insurance companies either. 

File Sharing Peer to Peer Programs Still Posing Risk to Exposing Patient Data – Think Twice About This

These folks are the same ones that are concerned about data security and just passed a huge Healthcare Reform package right?  This worries me.  What this says is that we have a bit of lack of education in software that almost every kid wants to use to get free music, videos and other items from connecting to another computer on the web, but yet we have leaders that have no clue what in the heck this is, been around for years and Napster was the beginning years ago. We have folks that don’t pay attention as to how technology is shaping our world.  Is there really a true understanding in Congress as to what HIPAA is all about?

We talk about health literacy, well consumer IT literacy needs to come first in my opinion as the 2 work together these days.  Many hospitals run systems that go out and scour the web for accidental abuses and they can find out who’s hanging out on porn sites too.

Peer to Peer Forensic Services – Enterprise solutions for Hospitals and other Health Agencies

Now we have members of Congress mad at Google as they potentially intercepted information from wireless devices from US Congressmen who didn’t have a lick of sense and left their wireless open without a password, so pot calling the kettle black here?

Members of Congress Not Locking Down Their Home Wireless Networks with Passwords Now Angered At Google For Snooping with Street Views?

Maybe this is why the Russian spies had such a cushy and easy job, maybe what they were looking for was all out there for free and Google should be the least of their worries, it’s the other folks they should worry about.  Jane Harman, chair of the Intelligence Subcommittee from Homeland Security was one that left her router open?  Huh??  There were 20 government officials in all that are upset with Google over their street views with the collection of data. 

How do we cure this, participate in the very basics of computer IT knowledge today, please.  Once this happens we can work on creating a higher level of health literacy, and while we are at it, get some role models out there besides the President, constituents would like to see this instead of having to read about the folks in the Pentagon getting busted for child pornography.  BD   

Several dozen Pentagon officials and contractors have been accused of -- and in some cases were convicted of -- purchasing and downloading child pornography on government computers, the Department of Defense's inspector general's office disclosed in documents released Friday. 

The investigation that led prosecutors to these government workers was actually part of a larger Immigration and Customs Enforcement agency sting called Operation Flicker, aimed at identifying individuals who paid money over the Internet to access child pornography overseas, according to the inspector general's office.

That sweep collected information on more than 5,000 people in 60 undercover stings involving 18 child porn websites. Among those were several dozen who worked for Pentagon intelligence services.

FOXNews.com - Investigator's Report Shows Dozens of Defense Employees Picked Up in Child Porn Sting

Technorati Tags: security breaches, healthcare, hospitals, medical records, doctors, electronic medical records, peer to peer, laws, Congress, non participants, tech denial, House, Senate, duh, porn, Department of Defense

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National Conference of State Legislatures Using Microsoft Tags At This Year’s Convention to Allow Attendees to Stay Informed and Engaged

This is great and goes right along with my advocacy for using Microsoft Tag Bar Coding.  At present I have about 30 articles on the Medical Quack written on this topic, why, because the technology stands to save lives is the the biggest reason.  Secondly it offers the FDA a solution to handle recalls with making information available to health care professionals and the public.  I see Nancy Pelosi is talking and I wonder if she will avail herself of the new technology?  The NCLS has issued their own press release which can be seen here. 

Below is a post from Microsoft Gov with an over all summary of how they can be used by device/drug companies, the FDA, the DEA and even a short blurb on how the White House can use them for events so no uninvited guest sneak in again. 

Microsoft Tags – Microsoft MSDN Posts Ideas from the Medical Quack About Use in Healthcare!

One thing for sure this conference will expose is the identification of the “participants” versus the “non participants” with being open to try and use new technology for solutions.  We have so many “non participants” around and that is such an issue as they could be role models if they were open to try and see the solutions that are possible today. 

Look what happens to be on the agenda – Healthcare Reform!  I see Cindy Mann, U.S. Department of Health and Human Services, Maryland speaking and wonder if she will connect with Tags and try them out. 

There’s also a working solution using the very same technology for the new DEA rules for e-prescribing and authenticating physicians – good stuff and video at the link below.

RAZCODE (Microsoft Tags) Using Smart Phones to authenticate MDs When e-Prescribing Controlled Substances

If that isn’t enough you can connect to HealthVault and Google Health with data input via Microsoft Tags/Razcodes.

Digital Health Tokens – Connect Google Health to HealthJibe – RAZCODE With Microsoft Tags

My poll seems to be moving along pretty good too and have had some nice Tweets on Twitter with consumers and hospital CIOs really liking the idea.  I might guess my regular readers at the Medical Quack might be chuckling a bit at some of this as it looks like the campaign could finally be having it’s day to see who’s really open to creating working and needed solutions.  Using Tags on your cell phone is easier than making a phone call and yet we see the “non participants” just run for the hills or perhaps take a stance of “that’s not cool”.  I have years of that experience with being a Tablet PC enthusiast so it lives unfortunately. 

Take time out and vote if you don’t mind and maybe we can open some minds and draw some out of the “tech denial closet”. 

We have HHS wanting to improve health literacy so perhaps with their representative attending here and trying out Microsoft Tags it might sink in a bit on how they are missing one big area of technology that is actually fun and will enhance involving the patients, everyone keeps missing this and gee, are they hiding in that “tech denial closet”.  This is a hands on consumer IT product that’s for everyone from Congress on down. 

HHS National Plan to Improve Health Literacy – Not Going To Happen Until We Focus on Using Technology (The Tool for Literacy) Which Includes Role Models at HHS And Other Places in Government

There’s a big list of exhibitors for the convention, some big names too and I wonder what they will do with the technology and at least maybe try it!  At minimum I would hope that the American Academy of Family Physicians would see the value here, since the doctors have to stay on top of all the recall and drug information. 

We have doctor’s groups suing the FDA now too due to a lack of a good notification program, so this needs to get going.

FDA Is Sued By Non Profit Doctors Group - Failure to Notify Diabetic Patients Of Alternatives for Avandia – Bar Coding and Scanning Product With A Cell Phone Could Solve the Problem

Even Kaiser Permanente is right on with working with bar codes and it is helping demonstrate how the use of medical records are creating better joint replacements for patients, bar codes tagging that information in the health records!

Kaiser Permanente Demonstrates Success of Large-Scale Total Joint Replacement Registry With Help from Health Connect PHR

One side of me says I would love to have a video with Nancy Pelosi discovering how to use Tags, again we as citizens do like to see our government leaders stand up and be role models as it certainly builds confidence among constituents.  Hopefully all are better educated too on general consumer health IT as in January of 2009 nobody in the Senate hearings and committees had even heard of a PHR or seen one and we are hopefully past that point.  We need more “participants” and less “non participants” with technology today for a better informed society and leaders that can in process create better laws and rules to protect and help all of us, as you have to include technology today with new legislation, otherwise leaders are not as effective as they should be and we all lose.  BD 

DENVER, July 23 -- The National Conference of State Legislatures issued the following news release: This year, NCSL will place "tags" or signs in various locations throughout the Kentucky International Center during its three-day meeting. A tag is a barcode that contains encoded information. When a participant takes a picture of the tag with their phone, the information encoded into the tag becomes available on the mobile device.

Users will need to download the Microsoft tag software (http://gettag.mobi/) to their Blackberry, iPhone, Android, EVO or any other smartphone to access the information from a tag sign. The software is free and easy to install. Basic instructions on how to download and use the Microsoft application will be located next to the tag signs at the Convention Center.
"Some of our participants are very active on their mobile phones. By using this technology, we allow them to stay engaged and informed at our meetings," said Gene Rose, communications director for NCSL.

http://www.tmcnet.com/usubmit/2010/07/23/4916883.htm

Technorati Tags: NCSL, National Conference of State Legislatures, Microsoft Tags, technology, recalls, government, tech denial, healthcare, cell phones, Pelosi, Congress, HHS, FDA, Bar codes, role models, medical devices, drugs, safety

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UCLA Oncology Radiation Study Reshaping Radiation Techniques - Extending Survival Rates For Patients with Brain Cancer - Stem Cell Niche Therapy

This is pretty specific and perhaps a little complicated reading here but the lives of those with brain cancer with this new technique on targeting potential cells in the brain that also harbor cancer cells appears to be extending the survival rates of patients with this horrible degree of cancer tumors in the brain, which would be anyone’s biggest nightmare as a patient. 

If you missed a recent post along the same lines you can view the link below and see what else is happening at the UCLA Cancer center with creating immune cells to seek out cancer and kill the cells in real time.  BD

UCLA Scientists Create Army of Tumor Fighting Immune Cells and Watch As They Seek Out and Kill Cancer in Real Time

Press Release:

Patients with deadly glioblastomas who received high doses of radiation that hit a portion of the brain that harbors neural stem cells had double the progression-free survival time as patients who had lower doses or no radiation targeting the area, a study from the Radiation Oncology Department at UCLA’s Jonsson Comprehensive Cancer Center has found.

Patients who underwent high doses of radiation that hit the specific neural stem cell site, known as the stem cell niche, experienced 15 months of progression-free survival, while patients receiving lower or no doses to this region experienced 7.2 months of progression-free survival, said Dr. Frank Pajonk, an associate professor of radiation oncology, a cancer center researcher and senior author of the study.

Pajonk said the study, published today in the early online edition of the journal BMC Cancer, could result in changes in the way radiation therapy is given to patients with these deadly brain cancers.

“Our study found that if you irradiated a part of the brain that was not necessarily part of the tumor the patients did better,” Pajonk said. “We have been struggling for years to come up with new combinations of drugs and targeted therapies that would improve survival for patients with glioblastoma. It may be that by re-shaping our radiation techniques we can extend survival for these patients.”

The retrospective study focused on the cases of 55 adult patients with grade 3 or grade 4 glioblastomas who received radiation at UCLA between February 2003 and May 2009. Pajonk said a prospective study is needed to confirm the results.

There is some evidence that many if not all cancers may spring from stem cells or progenitor cells that normally repair damage to the body, but that somehow become mutated and transform into cancer. In this case, Pajonk said the neural stem cell niche, called the periventricular region of the brain, may also be harboring stem cells that have transformed into brain cancer stem cells. However, the niche serves as a sort of safe harbor for the cancer stem cells, keeping them away from the site of the tumor but able to re-grow it once it’s removed and the malignant areas of the brain have been treated.

Pajonk theorizes that the brain cancer stem cells in the patients whose niches were irradiated with higher doses may have been damaged or eliminated, giving these patients more time before their cancer recurred.

“This suggests that the neural stem cell niche in the brain may be harboring cancer stem cells, thus providing novel therapy targets,” the study states. “We hypothesize that higher radiation doses to these niches improve patient survival by eradicating the cancer stem cells.”

Glioblastomas are the deadliest form of brain cancer. Surgery, chemotherapy and radiation are not usually effective and life expectancy is about 12 to 18 months. New and more effective treatments are needed to help this patient population, Pajonk said.

The radiation therapy could damage neural stem cells as well as the cancer stem cells, Pajonk said, but those may be replaceable at some future date using induced pluripotent stem cells made from the patient’s own cells. The induced pluripotent stem cells, which like embryonic stem cells can make every cell in the body, could be induced into becoming neural stem cells to replace those damaged or eradicated by the radiation to the niche.

The study was funded by National Cancer Institute.

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 2009, the Jonsson Cancer Center was named among the top 12 cancer centers nationwide by U.S. News & World Report, a ranking it has held for 10 consecutive years. For more information on the Jonsson Cancer Center, visit our website at http://www.cancer.ucla.edu.

Technorati Tags: UCLA Jonsson Cancer Center, Brain Cancer, Tumors, therapy, radiation, oncology, cancer centers, stem cell, brain, NIH Foundation

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Future of Joint Replacements – Regenerative Medicine - Dr. Kevin Stone Regrows the Knee Instead of an Artificial Replacement (Video)

This is a new frontier with joint replacements.  Dr. Stone talks about what he is exploring and uses the example of what he did for his wife with a “human” meniscus transplant.  Arthritis is becoming a huge area where many of us are suffering, as we are living longer and the knees need to go the extra miles. 

For his wife he was able to find a human donor for her.  When you see some of the results here and what patients are doing it’s amazing.  It is about regrowing tissue.  The problem is there’s not enough human tissue available.

He talks about the solution being “animal” tissue.  He has figured out how to use animal tissue from a cow and strip it and build a regenerative template to build upon.  This is a world wide FDA approved procedure.  He is also used pig ligaments with an FDA approved trial with 10 patients and some received awards in down hill skiing competition so this says a lot about durability too.  He talks about the next move with the entire knee replacement with growing using your own stem cells and creating a new surface. 

 

Pig tissue is being used in other areas as well and last year I had an opportunity to talk with Cook Medical and how they are using pig tissue and building scaffolds for hernia repair and other reconstructive areas with their Biodesign products. 

Regenerative Medicine and How it Works – Interview with Cook Biotech (Medical)

The interview is worth a read and if you are looking at joint replacement right now, be sure and check up on the latest developments as this seems to be moving very fast. 

 

This certainly sounds better than an artificial replacement and it will be interesting to see how this impacts the device business in this area.  BD

Arthritis and injury grind down millions of joints, but few get the best remedy -- real biological tissue. Kevin Stone shows a treatment that sidesteps the high costs and donor shortfall of human-to-human transplants with a novel use of animal tissue. (Recorded at TED University 2010, February 2010 in Long Beach, CA. Duration: 6:52)

TED Blog: The bio-future of joint replacement: Kevin Stone on TED.com

Technorati Tags: TED, knee surgery, stripping, biologic knee replacement, Bioware, Kevin Stone, Regenerative Medicine, Clinical Trials, Cook Medical, healthcare, technology, surgery, outpatient, stem cells

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Insurers Lobbying to Keep Rules Loose on Medical Loss Ratios to Maintain Profits

The current rules are calling for refunds from the insurance companies if they do not meet the amounts in the new laws for spending 85% of premiums payments on medical costs.  As noted here Senator Rockefeller wants to ask that fraud detection be excluded from the area of medical costs.  He might be on to something here too as this is where the big transactions occur and make millions for subsidiaries and 3rd parties.  United as an example could be using their subsidiary Ingenix to run fraud detection and of course they would get their normal transaction fees, so thus the money goes right back into the till of United if that is is the case.  United also owns a bank where HSA, health savings accounts are kept, so does that qualify for medical costs in helping support the bank?  

UnitedHealth Group Owns a Bank With Deposits Surpassing a Billion – OptumHealth Bank FDIC Insured

There are also many 3rd parties that offer fraud protection and business intelligence software that make big profits in selling their algorithms to insurers and those profits might be contained a bit and money saved it if in fact were not be churned and turned around.  One company is owned by a private equity firm in the UK and actually uses Ingenix products and pays for the software so here we go again with the big circle circulating back into United. 

Business Intelligence and Enhanced Claim Processing Goes to Puerto Rico With TriZetto for Medical Claim Processing and Algorithmic Analysis Services

The word “fraud” detection opens the doors to a ton of analytical services that make millions and billions on the stock market and granted we need some of these services but where do they fall into medical care, do they?  I actually wonder how much fraud is really caught when I read the stories in the news and how much of it is perhaps denials by the algorithms with the clause of “searching for fraud”.  The crooks always swim by as they know the claim game and how to avoid the intelligence that would put them into a fraud parameter report. Do premiums go to cover venture capital investments?

BlueCross BlueShield Venture Capital Firm invests in Phreesia

This will be interesting to see how this all shakes out with what is medical care in the classifications.  We might as well make an algorithm for it so we are all on the same path and have the insurers run their accounting functions through it so we can determine which accounting functions are allowed under the rules and which are not.

WellPoint Rate Increase Math Error – Time For a “Department of Algorithms” So Everybody Knows the Formulas?

If we had this more clearly spelled out we wouldn’t have to deal with “whoops” as the rules for hospitals and doctors they issue are clear and to the point or no compensation.  When someone needs care there’s no time for “whoops” when human lives are on the line.  BD   

WASHINGTON, July 22 (Reuters) - Insurers are trying to undermine the healthcare reform legislation by lobbying the rule writing process that would limit insurers' spending on non-medical costs, a consumer advocacy group said on Thursday.

The group Health Care for America Now issued a report saying insurers are waging a battle to make the rules as broad as possible, simply to maintain their profits.

"The insurance companies want to change the definition of medical care to include things that aren't medical, and to include things that never were considered to be medical," said Ethan Rome, director of Health Care for America Now, at a press conference also hosted by two Democratic lawmakers.

"The reason they don't want stricter regulations is simply because so many companies have been making outrageous profits by gouging American families," Sen. Al Franken said at a press conference announcing the report.

Nearly $1.9 billion would have been refunded in 2009 by the six largest for-profit health insurance companies had the rules been in effect, according to an Oppenheimer & Co analysis cited in the report.

UnitedHealth (UNH.N) would have spent $867 million in refunds last year, the report said.

On Tuesday, Sen. John D. Rockefeller IV wrote a letter to the president of the National Association of Insurance Commissioners -- which is drafting the rules -- urging the exclusion of services, such as fraud detection.

Insurers' lobbying threatens spending rules-report | Reuters

Technorati Tags: Medical Loss Ratio, Health insurance, lobbying, rules and incentives, Rockefeller, medical claims, algorithms, fraud

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Johns Hopkins Acquired All Children’s Hospital in St. Petersburg Florida For Little or No Cost

Many physicians have sold their practices to Children’s Hospital and are a little unsure about how things will run with Johns Hopkins as the new owner.  The name affiliation I am thinking would stand to draw more patients with the reputation that Johns Hopkins has.  Some physicians mentioned that they have been through more than one change in ownership with hospitals in Florida.  BD 

ST. PETERSBURG — The news that All Children's Hospital is becoming part of Johns Hopkins Health System has caused a major splash in the Tampa Bay area medical community.

"It's an acquisition," he said, saying the Baltimore group is assuming about $240 million in debt in exchange for a hospital with about $200 million in cash on its balance sheet. "In essence, All Children's is giving its hospital to Johns Hopkins for nothing. But if you're going to give up control to somebody, you may as well give it up to one of the finest medical centers in the world."

Though doctors who have sold their practices to All Children's and have become its employees are reportedly nervous about being replaced by Johns Hopkins, Nemzoff said after three decades of handling hospital acquisitions, he's never seen widespread physician turnover.

"Organizations are amenable to mixtures of relationships that would not have been doable a few years ago," he said.

The reason: money. With Medicaid cuts coming and the health reform bill affecting how and how much providers will be paid, everyone's looking for ways to reduce costs.

Ripples from All Children's-Johns Hopkins merger could touch many - St. Petersburg Times

Technorati Tags: Johns Hopkins, Florida, All Childen's Hospital, heatlhcare reform, hospital, mergers and acquisitions

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Florida Hospital System Threatening to Drop United HealthGroup Over Rates – Last Contract Was in 2001

There are always 2 sides to a story but 9 years indicates there’s a lot to talk about as a lot has changed during the last 9 years and if there has not been any increases in that amount of time, the hospital may have a good case to play a bit of hardball here.  This is pretty large as the Florida Hospital chain has 18 regional hospitals.   We have one chain in California that will not see patients who are covered by employer based plans from United. 

Employers in Orange County Looking for New HMO Contracts as St. Josephs and Some Others Begin Cancelling Agreements with Pacificare (UnitedHeatlhCare) – Employer Capitation Contracts

In New York there are also problems with contracts and the 24 hour notice rules.

United Healthcare to Hospitals – Notify Within 24 Hours of Patient Admittance or Reimbursement Will Be Cut in Half

It’s all about fitting into the rules and parameters of the “algorithms” of compliance for payment in the New York situation.  We are finding this becoming more apparent in many areas as the actual work flows of hospitals are having difficulties meeting some of the requirements needed in order to get paid.  At the link below the peer group, hospitalists and board could not figure out how to comprehend the parameters United needed.

Hospitalists, Peer Committees and Utilization Struggle to Comprehend United HealthCare Algorithms

In the Florida Hospital case the article states that letters of warning have been sent.  One of the administrators from the hospital said it is affecting care as the co-pays have risen too high and patients are not getting their medications and not seeing their doctors for screenings and lab tests.  BD 

The Florida Hospital system and United Healthcare are embroiled in a contract standoff. If the two companies cannot agree on new terms by Aug. 15, about 170,000 United Healthcare customers in Central Florida would be unable to go to the 18 regional hospitals in the Florida Hospital network for non-emergencies or visit doctors employed by and acilities owned by the chain.

Executives from both sides have been meeting since November, trying to negotiate a contract. But they remain at an impasse.

At issue are the rates the insurer pays the hospitals for services. Florida Hospital officials say they want United Healthcare to pay the same rates as other major insurers. But a United Healthcare spokesman said Florida Hospital wants to raise rates 63 percent during year period — and calls that kind of hike "unreasonable."

For example, the average cost for an outpatient service such as arthroscopic knee surgery would increase by about $700 next year, United Healthcare spokesman Daryl Richard said.

Florida Hospital officials, on the other hand, say the hospital chain's contract with United Healthcare has not been renegotiated since 2001.

"In the last few years, employers have tried to share the costs with employees, but they're getting to the point where they can't ask employees to shoulder any more of the burden," said Cherney, noting that copays are getting so high that some employees are now skipping medications or tests because of the cost.

Florida Hospital might dump United Healthcare if contract negotiations fail - OrlandoSentinel.com

Technorati Tags: United Healthcare, health insurance, branding, contracts, Florida Hosptals, healthcare reform, negotiations

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FDA Is Sued By Non Profit Doctors Group - Failure to Notify Diabetic Patients Of Alternatives for Avandia – Bar Coding and Scanning Product With A Cell Phone Could Solve the Problem

The Medical Quack is somehow turning into a blog about bar coding, why, because the news is full of articles about recalls, fake drugs, stolen drugs, defective devices, you name it.  We need the technology right now to be able to get the word out.  Would you not like the availability to scan either a product or a bar code and immediately read it on your smart phone?  If so, take time and vote.  The would have helped find the stolen Advair.

Stolen Advair Demonstrates Need for Tag Bar Coding of Drugs – Encrypted Bar Codes Could Identify Stolen and Counterfeits When Scanned With a Cell Phone

This same technology can also authenticate a physician with the new DEA rules, video at the link below.

RAZCODE (Microsoft Tags) Using Smart Phones to authenticate MDs When e-Prescribing Controlled Substances

People want this, read the tweets below from consumers and Health IT CIOs.  The demand is here for the information and it’s only going to stand to grow. 

The video below will show how it works, simple.  Wonder how many more lawsuits will be filed?  The solution is here today and it would make it easier for the FDA to work with compliance.  People die with implanted defective devices so it’s time to get to the solution of communicating with the technology that can fix the problem. 

Washington, DC—A nonprofit doctors group filed a lawsuit against the U.S. Food and Drug Administration (FDA) this month, after they failed to notify patients of dietary alternatives to dangerous diabetes drugs such as Avandia, a highly scrutinized diabetes medication. The group, Physicians Committee for Responsible Medicine (PCRM), alleged they petitioned the FDA to require that such alternatives be included on labels for the drugs, but to no avail, according to a Monday, July 19, 2010 PCRM news release.

The lawsuit contends, “PCRM’s petition requested that FDA require a disclosure in the labeling of drugs, such as Avandia, used to manage blood glucose in diabetes treatment. The disclosure would state that a low-fat plant-based diet has an efficacy and safety profile that can be as favorable as, or more favorable than, oral diabetes medications. FDA has failed to provide a substantive response to PCRM’s petition in a reasonable time, in violation of the Administrative Procedure Act.”

FDA Sued for Failure to Alert Diabetics to Effective Drug Alternatives | Justice News Flash | JusticeNewsFlash Release

Technorati Tags: Avandia, FDA, Lawsuit, healthcare, technology, tags, Microsoft Tags, safety, drugs

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Big Surpluses of Cash On Hand From Major Health Insurers - Billions

When you stop and look at what this study came up with for 10 states and only one carrier, can you imagine what the “reserves” might be across the country if all were tallied up.  From a post from a couple years ago, 3 carriers in the state of Washington found this group of 3 carriers had 2.2 billion and that was in the year 2006.

Health Insurance Reserves – How much is in the till, could it be 1 or 2 trillion nationwide? 

By law, insurance carriers are supposed to have “reserve cash files” or rainy day funds and we found out when Wall Street crashed a couple years ago how some companies like AIG didn’t have solvent reserves.  BD

Nonprofit Blue Cross and Blue Shield health insurers in several states have accumulated billions of dollars in surplus money over the last decade even as they continued to raise their insurance rates by as much as 20% annually for many customers, according to a report Thursday.

The study by Consumers Union found that seven of 10 such health plans across the country held more than three times the amount of surplus funds needed to remain solvent.

The plans that were studied are in Alabama, Arizona, Massachusetts, Michigan, New York, North Carolina, Oregon, Pennsylvania, Tennessee and Wyoming. They held more than $32 billion in surplus cash at the end of 2008, the report said.

Blue Cross and Blue Shield insurers amass huge surpluses | Money & Company | Los Angeles Times

Technorati Tags: Health Insurance, Health Insurance Reserves, Healthcare, Blue Cross, Venture Capital, Study

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Patient Rolls Off Operating Table During Routine Surgery – Family Filing Lawsuit For Wrongful Death

The family is suing and the amount is not known.  The Velcro straps that held the patient to the operating table evidently gave way and the patient fell to the floor. 

The accident happened in St. Paul at St. Joseph’s hospital.  The family is also asking the hospital to make changes.  He had just survived a stroke and was fine with that procedure.  The family states the table is not wide enough, the patient weighed 330 pounds.  He was sedated.  He fell on the side of his head where he had previous surgery.  This is sad story.  BD 

ST. PAUL, Minn. - Family members of a man who died after rolling off the operating table during surgery are suing St. Joseph’s Hospital, claiming negligence.

On March 8, 61-year-old Max DeVries was scheduled to have a routine surgical procedure to replace a lumbar drain. DeVries, at 5’5 and 330 lbs, rolled off the operating table while sedated and landed on part of his head where a portion of his skull had been removed in a prior surgery.

Bleeding severely, DeVries was rushed to get a CT scan of his brain, and was transferred to intensive care. He died on April 13.

Lawsuit: Patient Rolls Off Operating Table, Dies | Max DeVries

Technorati Tags: hospital, surgery, St. Josephs Hospital, Minnesota, safety, lawsuit, wrongful death

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Cardiac Science Partners with Best Buy Geek Squad And/Or IT Experts For Sales, Tech Support and Consulting To Include Medical Record and Device Connectivity

Well it looks like electronic medical records support has reached the retail level.  The article is not too specific on exactly which services they will be supporting but I might guess the medical records part of the business, HeartCentrix might be right in there as it will communicate with various devices that record and collect data and transport to an EHR/EMR system.  Back in April Best Buy did a survey to see if consumers would buy their healthcare devices from the electronics chain. 

Would You Buy Blood Pressure and Glucose Devices At Best Buy – Pilot Program In New Jersey

Currently the web site lists Allscripts, GEMMS, Greenway, MEDENT, MicroMD, NextGen, and Sage as partners.  In addition the software connects to ECGs, holter monitoring and automated external defibrillators.  Will the folks at Best Buy be giving the medical records folks to be trained via grants from HHS and ONC a run for their money:)

If things get much tighter though, would you see your doctor working there too to reduce travel time for the Geek Squad to stay on revenue targets and meet goals?   Don’t think that couldn’t happen as one young doctor works part time at Blockbuster so she can have health insurance, 6 years out of residency and scary what is happening in compensation for young doctors. 

From the website:

“HeartCentrix ECG / EKG data management centralizes diagnostic cardiology data for rapid access. Pyramis, our flagship HeartCentrix product for the hospital market, uses open architecture to meet your needs – so there’s no reason to invest in custom software or hardware.
You save time since Pyramis works with Health Level 7 (HL7) interfaces. And Pyramis delivers the accuracy and reliability you expect from the company that brings you Quinton and Burdick brands, cardiac diagnostic leaders for almost a century now.”

Through the Pyramis network, connections to hospitals are also an option.  This kind of makes me wonder if we will be seeing Geeks in Scrubs soon (grin).  BD

Best Buy Co. Inc’s small-business service unit is teaming with Cardiac Science Corp. in an effort to boost technology use among physicians.

Best Buy For Business, a unit of the Richfield-based retailer (NYSE: BBY) that sells tech services to business customers, said the time is right to pursue the market segment of doctor’s offices and clinics.

Best Buy will send members of its Geek Squad or IT experts to provide consultation, sales, installation and technical support for its software. Cardiac Science will handle sales, installation, training and technical support for its medical devices.

Based in Bothell, Wash., Cardiac Science designs, manufactures and markets diagnostic and therapeutic cardiology devices and systems, such as external defibrillators. The partnership will allow doctors to use programs such as CareCenter MD, a PC-based diagnostic tool for ECG and stress.

Best Buy partnership aims to improve tech use by docs - Minneapolis / St. Paul Business Journal

Technorati Tags: Cardiac Science, Pyramis, Best Buy, HL7, software, devices that report data, cardiology, wirless, Geek Squad, medical devices, EMR/EHR, medical records

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General Accounting Office Goes Under Cover to Review Consumer Genetic Companies – Are Varying Answers Like Getting a Second Opinion with Doctors?

The entire purpose here was to see what the different companies found with the analytics and there were some variations, just like you would have if you went to see 4 different doctors.  The FDA has classified the tests as “medical devices” so this investigation might be a continuation on how to handle the consumer DNA firms and assure good quality information.  

FDA States Genetic Tests Are Considered a Medical Device And Thus Need FDA Approval

Hearings are to be held at the FDA to come to some type of conclusion as to how the DNA screenings should be handled and FDA approved. 

So, my question would be to wonder if this is like a 2nd opinion for doctors, would you go get a second one if you felt the first was not correct?  It’s all in the interpretation and a couple years ago when I spoke with the Chief Science Officer at Helicos, we talked about the same thing and today there’s still no exact answer here.  BD

Helicos BioSciences and Personalized Medicine - Featured Interview with Dr. Patrice Milos

The firms cited in the report include 23andMe, Pathway Genomics, DeCode Genetics and Navigenics, an official at the G.A.O. said Thursday during a Congressional hearing into such tests. Based in Mountainview, Calif., 23andMe is backed by financing from Google, and the company’s president, Anne Wojcicki, is the wife of Sergei Brin, a co-founder of Google.

Updated: An undercover investigation of some firms that sell genetic test kits to consumers found misleading test results and “egregious examples of deceptive marketing,” according to a report published today by the Government Accountability Office.

(Clarification:) The report said the four companies had sent the donors different results for the same sample and told donors they were at lower risk for getting diseases they already had, while two other companies suggested that a customer’s DNA could be used to create personalized supplements to cure diseases.

Federal ‘Sting’ Slams Gene Tests - Prescriptions Blog - NYTimes.com

Technorati Tags: enomics, personalized medicine, DNA, healthcare, sequencing, Biotech, pharmacogenomics, FDA, Tags, 3D barcoding, medical devices, GAO, General Accounting Office

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Health Net Creates Additional Performance Algorithms by Contracting With MedeAnalytics

Hopefully as a provider your group, HMO, or IPA will help assemble some of the new informatics if you are a physician.  What this means to the rest of us is the potential of one more transaction coming out of that claim that is filed to fill a corporate piggy bank.  There’s a lot of 3rd party software out there that are deemed to just have you perform like you have never done it before (grin). Certainly there’s a need for analytics but the field is over crowded and from what i am hearing, the doctors are over indulged right now and the parameters to first of all understand are getting too complicated, yet along collect on any pay for performance carrots.  

It would be nice if the government at this point would just wipe out half of this and either create their own program or use 1-2 contractors to get rid of the glut ands save us all some money on Wall Street as these are the guys making million and billions as they are traded.  I guess in researching this blog I read so many of these announcements and look at so much software, it all looks the same and heck I have a hard time just getting through EHR and PHR discussions with your average MD so again this is so way over done.

When you look at how analytics are handled today with carrots, even the Meaningful Use folks over shot the barrel, and that I attribute to not enough first hand experience with hands on with real people and situations.  We are to the point with complexity of software that you don’t dare shoot your mouth off over a “proof of concept” anymore, as we are beyond that and really need folks who “get it”. 

The problems are that payers are not certified with their algorithms and formulas and for one they are dumping more private information out there than any EHR has by a long shot, so we don’t have the entire solution and won’t have until we get some of their algorithms to certify that they work and gain trust in what they say and do. 

If you look at the clients with MedeAnalytics you will see hospitals and insurers that you probably recognize on the list such as Cleveland Clinic and Blue Shield of California. 

It gets back to what I say has been going on for years, it’s a battle of technology and the algorithms, the insurers and Wall Street have machine guns and the rest of us are still running around with swords and daggers.  There’s value by all means to analytics and we need it, but there’s also the issue that we might have a number of companies and individuals almost to the point of needing a 12 step program to help with the addiction to the process as money is driving many almost to this edge.  BD 

EMERYVILLE, Calif., July 22 /PRNewswire/ -- MedeAnalytics, a leading provider of healthcare performance management solutions, announced that it has entered into a multi-year agreement with Health Net, Inc. (NYSE: HNT) to provide performance management solutions for Health Net's health plan operations and Medicare products. The solutions will enhance Health Net's current data analytics capabilities and include Medical Management Analytics, Provider Network Management Analytics and Operations Performance Management.

Medical Management Analytics helps manage medical costs through quality improvement and utilization management. Specific key performance measures include emergency room coding and utilization, readmissions, one-day stays, length-of-stay efficiency and asthma therapy.

Medical Management Analytics helps manage medical costs through quality improvement and utilization management. Specific key performance measures include emergency room coding and utilization, readmissions, one-day stays, length-of-stay efficiency and asthma therapy.

Provider Network Management Analytics provides a deep understanding of the network providers and their performance. This includes outcomes, provider practice patterns and identification of outliers.

Operations Performance Management leverages insight into metrics that must be monitored by health plans, such as claims processing, denials and appeals. Examples include volumes of claims processed, how long it takes to process a claim, denial rates and overturned appeal rates.

"The current economic and regulatory environment is placing increased demands on payers," said Scott Paddock, senior vice president, Payer Solutions. "As a result, payers such as Health Net are moving to ensure that they have responsive, dynamic business intelligence capabilities that, when combined with workflow and document management, yield superior performance management. Our payer clients span the U.S., and we are pleased to help them control costs and navigate these challenging waters."

Health Net Signs Multi-Year Agreement with MedeAnalytics -- EMERYVILLE, Calif., July 22 /PRNewswire/ --

Technorati Tags: Healthnet, analytics, MedeAnalytics, health insurane, pay for performance, transactions, profits, Wall Street, budgets

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FDA Heparin Investigation In Conjunction with Chinese Officials Strained and A Lot of Unfinished Business And No Technology Advances to Help the Cause

Back in November of 2008 with the initial visits to China by former FDA Commissioner von Eschenbach and former HHS Secretary Leavitt was kicked off with a ribbon cutting ceremony to open the first US FDA Office in China. 

First US FDA office unveiled in Beijing

This was a major issue with contaminated heparin shipped to the US from the factory in China.  The link below will offer a little refresh on the situation. 

U.S. probes Chinese factory’s ties to heparin ills

A subsidiary of a US health insurance company is investing in a company that has a line of communication with the US FDA to work to promote the sale of more Chinese drugs and devices to the US and globally.  

UnitedHealth subsidiary (Ingenix Subsidiary I3) Acquires ChinaGate – Working to Sell Chinese Products Globally

According to the information written here, the FDA was not allowed access to the factory.  I am sure we will here more as this carries forward.  There’s only a few US employees there and China is a big place so set up servers and collect data on quality control lot before the product is shipped, you can’t do it all manually and this would help the employees – wrote this up back in 2008, link below.

It is amazing to me how we can totally weight down hospitals and doctor and hammer on them for probability and yet we can’t get going on something that will benefit all of us with automation, amazing but what you come up with when politicians that are tech non participants. 

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

Again, this comes back to adding some new software and algorithms to the process, but computers could provide this information in a couple of seconds.  Audit trails would also be there to allow for checking back on submissions.  A bank of sophisticated server farms could do the work.  This would also tend to build product credibility as well if everyone knows up front that the chemical content was being reported before the end packaging occurs.  Again, not to replace an actual physical inspection all together, but, it would also stand to make those inspections much more information rich and valuable and create safe consumable products.

While we are at it too, knock out the use of blind bills of lading too so the origin can be accurate and not hidden.  This has gone on in logistics forever. 

More Candy From China – Are “Blind” Bills of Lading adding to the confusion and delay in locating the products for recall?

We could also be using Microsoft Tags on the products too so send those quality control numbers and tag that lot and print on the label so we can all use our cell phones to find this stuff. 

FDA Publishes Information on How to Identify Recalls – Why Not Scan That Stent With A Cell Phone and Make It Easy for the Public and Manufacturers To Keep Up, Notify And Automate Compliance

The even miss some of their own stuff getting out to the public.  BD

The Unknown FDA Recall of Bayer's Yaz Contraceptive Pills (And Some Prempro Too)

An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had "severely hampered" a Food and Drug Administration probe into contaminated heparin.

In a letter to FDA commissioner Dr. Margaret Hamburg, the two congressmen--who both sit on the House Energy and Commerce committee--said that FDA officials informed them in June that the agency was "denied full access to manufacturing and laboratory facilities," nor were they allowed to review records.

The FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008.

"It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why," Barton said. "Instead, like it often does when it's been embarrassed, the Chinese government raised a great wall to separate legitimate inquiry from hidden knowledge."

http://trailblazersblog.dallasnews.com/archives/2010/07/barton-burgess-probe-finds-chi.html

Related Reading:

Business Intelligence for the FDA on the way

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

Congress to industry: 'We need your help'

Technorati Tags: FDA, China, phamaceutical plant inspections, FDA funding, Congress Pharma, tags, bar coding, safety, healthcare, technology

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