Federal regulators will soon swap out an antiquated medical coding system for a new one that describes modern health practices more precisely. But the transition is going to hurt.

ICD-10 is the new system. It increases by a factor of 10 the number of codes specifying medical conditions and procedures in the US health system. The increased specificity should allow insurers to assign payments that accurately reflect the complexity and intensity of medical services.

As a bonus, the improved data should facilitate quality improvement projects and retrospective studies like the one revealing an adverse interaction between heartburn drugs and Plavix.

But many worry that the transition will be costly and error-prone. Minimally, thousands of providers will have to purchase new software and train nurses, physicians and coders. In fact, the Centers for Medicare and Medicaid Services, the agency that oversees the system, expects implementation costs to top $1.5 billion.

This estimate doesn’t include waste associated with an inevitable increase in coding errors as people get used to ICD-10. It also doesn’t account for a likely increase in billing fraud and payment delays.

There’s also concern that CMS’ proposed 3-year roll-out is too aggressive.

CMS’ recent track record on large implementation projects is not reassuring. In the last two months alone it has been accused of bungling the transition to a new claims processor and called out by a US Senator for poor service on its 1-800-Medicare help line.

ICD-10 implementation dwarfs those challenges.

Heartburn drugs like Nexium, Prilosec and other so-called proton-pump inhibitors interfere with the heart-protecting function of Plavix, according to a study presented at last week’s annual meeting of the American Heart Association.

Among its many benefits, Plavix reduces the risk of future heart attacks in patients that have already sustained one. It also reduces the risk of life-threatening blood clots in patients that have undergone coronary stenting or balloon angioplasty.

But in its retrospective, claims-based study of nearly 17,000 people who received Plavix following stent placement or angioplasty, pharmacy-benefits giant Medco Health Solutions reported that the subset also taking heartburn drugs had a 50% higher risk of heart attacks and other cardiac events.

It’s a vexing problem for physicians because heartburn, stomach ulcers and gastritis are common side effects of Plavix, and nearly half of all Plavix users take Nexium, Prilosec or another proton-pump inhibitor to minimize these side effects.

And it’s a high-stakes problem for the pharmaceutical companies that market these drugs. Plavix, which is co-marketed by Bristol-Meyers Squibb and Sanofi-Aventis, topped $4 billion in sales last year. Astra-Zeneca’s Nexium was the 4th largest selling drug in the US last year, with sales of $5.5 billion. The percentage of Nexium users also taking Plavix is unknown.

A separate study presented at the AHA meetings added complexity to the matter because it seemed to show that proton-pump inhibitors increased cardiac risk all by themselves.

Larry Lesko, the FDA’s director of clinical pharmacology told the Wall Street Journal that his department will begin investigating the matter shortly.  Meanwhile, people who take Plavix and heartburn drugs should consult their physicians.

The Cleveland Clinic is test driving HealthVault, Microsoft’s Web-based personal health record.

Officials representing the prestigious health care provider indicated that the pilot began November 3. It’s the first one to track multiple diseases using multiple home-based medical devices.

The pilot will enroll 400 patient volunteers that have various combinations of diabetes, hypertension and heart failure. The multitasking volunteers will utilize HealthVault-enabled heart rate and blood pressure monitors, glucometers, weight scales and maybe even their kitchen sinks to monitor daily fluctuations in their health status (no word yet on which kitchen sinks are HealthVault-enabled, by the way).

Using their computers, volunteers will upload all that data into their HealthVault record and share it in secure fashion with their physicians at the Clinic.

The Cleveland Clinic already offers patients a home-grown personal health record known as MyChart. It claims that 150,000 patients use MyChart. Comparisons of the two systems are not available, nor were statements regarding the marginal value of HealthVault in MyChart users, the two systems’ interoperability, pilot costs etc.

It also remained unclear how the pilot would be evaluated and by whom. Financial terms and strategic objectives of the Microsoft-Cleveland Clinic hook-up were not disclosed.

“These kinds of innovative solutions have the potential to help physicians and patients save time, improve accuracy of health information and communicate more effectively,” said Christopher Hebert, MD, of the Clinic’s Nephrology and Hypertension Department.

“We expect to demonstrate that innovative, cost-effective technology solutions can empower patients to partner more effectively with their physicians and better manage their chronic conditions from where they live and play – in the home,” said Peter Neupert, corporate vice president of Microsoft’s Health Solutions Group.

In 1983, Ronald Reagan threatened to build a space-based laser defense system that could obliterate Soviet nuclear missiles before they left their own airspace.  Reagan called it the Strategic Defense Initiative, but Ed Kennedy derided it as a “reckless Star Wars scheme,” knowing full well the technology wasn’t there.

Kennedy was right and Star Wars never got built, but Reagan’s bluster may have nevertheless accelerated the implosion of the Soviet regime by forcing it to account for the billions of rubles it would take to maintain technology parity with the US at a time when its economy was going down the toilet.

Now, 25 years after Reagan’s Star Wars political checkmate, the US military appears to be back in the ray gun business. And this time, the early prototypes actually work.

At an undisclosed location probably in Iraq, an undisclosed branch of the military, probably the US Army has deployed Zeus, a “directed energy weapon” to destroy unexploded ordinance like roadside bombs from a safe distance.

Until now, the military completed this unsavory task with rocket propelled grenades, but RPGs are expensive and they have an annoying tendency to not go where they’re supposed to. Reportedly the laser goes where it’s aimed, and it works from 400 yards out so soldiers don’t have to expose themselves to sniper fire during the disarmament process.

(more…)

Giving patients written instructions on the proper use of blood thinning medication reduces the risk of life threatening complications such as gastrointestinal bleeding and hemorrhagic stroke, according to the results of a study published in the Journal of General Internal Medicine.

Dr. Joshua P. Metlay and his team at the University of Pennsylvania reached this conclusion after studying 2,346 elderly patients that took Coumadin for various reasons.

The scientists found that only 55% of patients in the study recalled getting medication instructions of any type from nurses or physicians.

Patients that did recall receiving instructions from a nurse or a doctor plus a pharmacist were 60% less likely to incur a serious bleeding complication in the ensuing 2 years. This benefit was independent of cognitive function, patient age, living arrangements and the number of co-administered medications.

Only written instructions seemed to make a difference. Verbal instructions did not reduce the risk of bleeding complications.

“While we do not know the specific mechanism linking the medication instructions to reduced bleeding risk, it is likely that improved communication about medications leads to increased drug adherence and earlier recognition of medication side effects,” Dr. Metlay said in a press release picked up by the Washington Post.

The results of the study support the FDA’s 2006 mandate that a medication guide be distributed to patients taking Coumadin. The study design used here did not allow scientists to determine the optimal format for written instructions or to evaluate the instructions put forward by Bristol-Meyers, the makers of Coumadin, in response to the FDA mandate.

No one needs to hear more bad news about the economy, but it keeps coming anyway.

Last week Circuit City, the nation’s second largest electronics retailer filed for Chapter 11 bankruptcy protection. 8,000 jobs will be lost.  It’s the latest of 14 major retail chains, including Steve & Barry’s, Mervyn’s and Linens ‘n Things to file for bankruptcy protection in the last 12 months.

And since most can’t line up financing to reorganize and come out swinging, they simply liquidate and disappear.

A tenth of the American workforce works in retail, but in the last year a quarter of all US job losses—320,000 according to the Wall Street Journal—have been in this sector. This doesn’t include another 200,000 workers whose employment has been switched from full- to part-time.

The pummeling of retail speaks volumes about the severity of the Great Economic Crisis of 2008. In mild recessions such as the one linked to the dot com collapse and the terrorist attacks of 2001, retail employment hangs in there for a long time because consumers continue to spend, maybe not as much but at least some.

Not so this time. Job losses in retail are already more severe than in financial services, automotive manufacturing and hospitality, and experts think the worst is yet to come.

Now for the bad news. Retail jobs have traditionally served as an economic safety net for Americans. If we needed a second job to make ends meet, we found it in retail. If we got laid off from a manufacturing job, we ended up in retail. If we were fresh out of college and couldn’t get a dream job, we headed for retail. Same thing if we didn’t go to college in the first place.

Forget that.

Medicare owes tens of millions of dollars to physicians in California, Nevada and Hawaii. The delinquent payments are in some cases so large and so late that physicians have been forced to turn away beneficiaries, lay off staff and default on rent.

Medicare owes Tim Ganey and his oncology practice $750,000 for example, and as a consequence the practice doesn’t have cash to purchase chemotherapy drugs for its patients. So it either needs to take out a loan, cajole the drug companies, or admit patients to hospitals which are inconvenient and inefficient places for cancer therapy.

Things have gotten so bad for Walnut Creek cardiologist Sally Davis that she’s taken to doing the office laundry to save money. Davis told the Los Angeles Times that Medicare owes her practice $700,000.

The payment delays result from Rube Goldberg-like process complexity in 2 organizations.

Earlier this year, the Centers for Medicare and Medicaid Services began assigning new ID numbers to physicians as part of its plan to expedite Medicare payment. ID assignments were supposed to be complete by May but physicians in some western states had not received their numbers by September.

That was when CMS switched Medicare claims processors for those western states, and the handoff didn’t go well. The new vendor, Palmetto GBA of South Carolina had to contend with unstable CMS databases arising from the ID project. It may not have received properly formatted information from CMS or the previous vendor. And it managed to botch a host of mundane administrative tasks like processing address change requests.

Then, when Palmetto went live it was not staffed to handle the flood of calls from irate physicians. Palmetto’s call center received 45,000 calls that first day. It was staffed for 2,500. Three months after start-up, 90% of calls to Palmetto were still greeted by a busy signal.

But CMS officials have defended Palmetto. Torris Smith, an associate regional administrator pointed to Palmetto’s 40 years of experience as a Medicare contractor and asserted the organization was selected using a “full and open competition.”

“There are always going to be general transition issues,” Smith told the Times. He added that the backlog of applications for the ID numbers should be cleared out by the end of the year.

No word though on when the docs actually get paid.

We’ve deployed nanoparticles (that is, particles measured in billionths of a meter) in the war on cancer for awhile now. For example, Abraxane packages the breast-cancer drug Taxol with albumin, a tiny blood protein that improves drug delivery and reduces side-effects.

Now, scientists have begun testing a new generation of nanoparticles that attack malignancies in a different way. By focusing energy from external sources, the new nanoparticles destroy cancers physically rather than chemically.

Jennifer West at Rice University for example, has developed gold- and silicon-based nanoparticles that absorb infra-red light and then heat up. If we can deliver these nuggets exclusively to the site of a cancer and turn on the juice, the tumor cooks while normal tissue remains unharmed.

It turns out this is quite possible because the pores of tumor capillaries are many nanometers larger than normal. It’s just a matter of creating nanoparticles exactly the right size to exploit the difference.

West’s nanoparticles have proven effective and safe in mice and dogs. Her team has begun testing them in humans with head and neck cancer.

Other teams are deploying nanoparticles of their own. The privately held German company MagForce Nanotechnologies for example, injects iron-containing particles directly into tumors and heats them with magnetic fields.

And the Taxol/albumin vehicle is only the first of what will likely be many cancer-fighting, drug-based nanoparticles. CytImmune Sciences of Rockville, Maryland has initiated a study of another gold nanoparticle that delivers tumor necrosis factor, while Calando Pharmaceuticals of Pasadena, California has enclosed camptothecin in a protective nanoparticle made of sugar.

The particular nanoparticles mentioned here may or may not prove effective, but those leaky tumor capillaries provide an opening big enough to drive a truck through.

Just months ago, gas cost more than Chanel No. 5 and the presidential candidates loved every green technology they could name. But the Great Economic Crisis of 2008 took the steam out of clean.

T. Boone Pickens, who bet $58 million on wind power said last week that plummeting oil prices and challenging credit markets will “put off” the boom. The NEX, an index of clean-tech stocks, is down twice as much as the Dow since January, and several American utilities have slashed near-term investments in clean energy.

Florida Power and Light for example, reduced by 400 megawatts its investment in wind power for next year, while North Carolina’s Duke Energy slashed $50 million from next year’s solar power budget.

But long term prospects remain excellent for green tech. The world still needs energy, argues Steve Sawyer, head of the Global Wind Energy Council in last week’s Economist. And investing in fossil fuel-derived sources carries risks of its own, as recent oil price gyrations have demonstrated.

Meanwhile, the Big O argues persuasively that green tech addresses global warming while creating jobs that can’t be shipped overseas (someone has to unwind the rubber bands attached to the wind farm propellers, right?). Even Congress gave green tech the green light by adding renewable energy subsidies to last month’s bailout.

Green companies with solid business plans, especially those likely to generate revenue in the short term, are raising capital even now. EDF Nouvelles, a European renewable-energy firm, just raised $734 million in a secondary share issue. GridPoint, a US start-up focusing on improving electrical grid efficiency, just raised $120 million. And wind turbine and solar panel manufacturers still have long waiting-lists

Which is good because long term, global warming is a bigger problem than global economic cooling.

In the US, utilization of CT and MRI scanning increased 43% between 2002 and 2007 to 96 million procedures. PET scanning tripled over the same period.

Americans did not get sicker during this time, nor had the medical community been inundated with evidence suggesting the tests were underutilized beforehand. In fact before the most recent imaging fiesta began, experts had estimated that 30% of all scans were unnecessary.

The drivers of inappropriate scanning haven’t changed in 30 years. Patients want the reassurance. Physicians want protection from litigation and sometimes, physicians benefit financially from the tests they order.

This state of affairs is unacceptable for two reasons. First, the scans can cause harm, either by direct radiation exposure in the case of CT, or by obligating risky invasive interventions to track down false positive results. Second, imaging tests are expensive. It costs $228 dollars for a CT scan, $977 for an MRI and $2,000 for a PET.

Health care providers see themselves as guardians of the quality of care, but for the most part their efforts to do so are patchwork and ineffective. There are some guidelines, an occasional implementation strategy, a performance measurement system or two, and a rare link between pay and performance, but the whole thing doesn’t add up as the above statistics suggest.

Yet they howl like coyotes when payers hire radiology benefits managers, known lovingly in the industry as Radiology Police, to oversee the matter. No less than three such organizations, CareCore National, American Imaging Management and National Imaging Associates turn a profit doing just that.

Those profits are a measure of waste in the US health care system.

The situation begs for providers to take ownership of the situation, and now for the first time they have the tools to do so. Plenty of good guidelines are available and EMR systems that support real time, guidelines-based quality checks give providers an unprecedented opportunity. We can do this, guys!

Two summers ago, Chinese authorities discovered that melamine, a nitrogen-rich chemical used to make plastics and fertilizer, had been added to pet food which was then exported to the US. The tainted food poisoned thousands of dogs and cats.

Officials subsequently banned melamine from animal and human food, and designated it a controlled substance. This meant the government was supposed to supervise all aspects of its production and distribution.

Soon thereafter, melamine got into China’s milk supply, sickened 54,000 babies, killed four and indelibly stained the nation’s reputation as factory for the world’s goods.

How could that happen?

Simply put, the government’s surveillance plan proved to be no match for a hellish combination of impoverished farmers, chemical manufacturers out to increase profits, organized crime syndicates and complicit local officials.

Few in China’s army of small dairy farmers had heard about the pet food scandal and even fewer had ever heard of melamine. But they all knew where to get tasteless, white “protein powder” that supposedly rendered milk more nutritious and marketable, and when added to plain water created a slurry that could pass quality tests for milk all by itself.

The farmers claim they were not told the powder was a poison. Many had been squeezed between rising commodity prices and government price controls and could not break even without melamine economics.

The “protein powder” distributers were actually organized crime syndicates that secured the toxic substance from chemical manufacturing plants. They sold the powder out of legitimate-looking stores, placed representatives at milk production facilities, utilized door-to-door salesmen and stood by to answer questions about how to use the product.

The toxic powder was produced by chemical engineers who purchased scrap melamine, a byproduct of various manufacturing processes, and converted it to a form that would dissolve in water.

The manufacturers were pleasantly surprised to profit from something they had heretofore called waste. They dared not ask why customers wanted melamine scrap.

“I don’t know if my customers tell me the truth or not. I didn’t ask for what purpose they buy it,” Liu Qiujiang told the Washington Post. Liu works at a chemical company situated near the headquarters of the Sanlu group, a diary company at the epicenter of the national disgrace.

The convenience store is a fixture of Americana. There are 150,000 of them in the US, and collectively they do $577 billion in annual sales. That’s 4% of our gross domestic product.

But the truth is Japanese convenience stores are more convenient.

You can’t buy 900 calorie soft drinks or roller grilled hot dogs at Japanese convenience stores, but you can buy hot soup, cold beer, french fries, fresh sushi and fresh pastries. Fresh food is available because delivery trucks stop up to 10 times per day to drop off new stuff and cart off perishables that haven’t sold fast enough.

And the toilets are spotless.

Oh, and you can book concert tickets or airline tickets, order home appliances, sign up for driver’s education, change diapers, pay taxes, or pay bills at Japanese convenience stores.  Japanese people paid $80 billion worth of bills this way last year.

Not yet convinced? You can drop off luggage for your next shinkansen ride and get this, you can park your baby stroller at the small indoor play area next to a bar that serves vodka coolers.

“For mothers to maybe have a sip of alcohol while children play is, I think, welcome,” Kazuo Kimera told the Washington Post. She works for Lawson Inc, which operates 8,600 convenience stores in Japan.

Lawson’s also caters to Japan’s aging population by carrying false teeth cleansers, gravesite adornments, hair dyes and so forth. They’ve widened the aisles and enlarged the print on signage. Most stores have blood-pressure machines and lounge chairs as well.

At FamilyMart, another ubiquitous Japanese convenience store, you can arrange for someone to clean your home, and at a Japanese 7-Eleven you can drop off your laundry.

Japanese convenience stores also coordinate with the government to distribute water and other emergency supplies after natural disasters like earthquakes. And they are viewed as places of refuge where victims of physical abuse can wait for the police. Last year 40,000 Japanese used convenience stores for this purpose.

Convenience stores aren’t exportable thank heavens, but the concept of a more convenient convenience store is. Hmmm…

Google Flu Trends, a recently released free tool from the company’s philanthropic division, Google.org, may detect regional influenza outbreaks 7-10 days faster than traditional methods.

And the same early-warning technology can probably be used to detect outbreaks of food borne illnesses and bioterrorist attacks as well.

Google’s bio-surveillance tool relies on the fact that many people enter phrases like “do I have the flu?” into search engines long before calling their physicians. Working with the Centers for Disease Control, Google created a basket of search phrases that suggest influenza and then aggregated all the hits by location. Terms like thermometer, muscle aches, and flu symptoms made the list.

Flu Trends utilizes terms like minimal, moderate, and intense to describe flu-related search activity and displays its results on a map (shown), along with flu prevention tips, vaccination site locators and links to helpful Web sites.

This process is light-years ahead of normal tracking systems which rely on people to visit a  doctor and get tested for the flu, and then for positive results to be relayed to and analyzed by the CDC.

Last February for example, the CDC reported an influenza outbreak in mid-Atlantic states, but in retrospect Google’s search data had revealed a regional spike in flu-related search activity 2 weeks earlier.

Superior lead times can save lives by enabling officials to target educational campaigns and resources where they are needed, and by motivating people to ramp up personal hygiene practices like hand washing . 

As compelling and wonderfully modern as this sounds, Google Flu Trends is still an emerging technology that must undergo rigorous prospective testing. The tool will inevitably be associated with false positive reports for example, because common but less deadly viral illnesses present with the same symptoms as influenza. The inclusion or exclusion of certain phrases into the above-mentioned basket of terms is likely to impact the tool’s accuracy.

A research paper outlining Google Flu Trends methodology will soon be published in Nature. That’s a good start.

Female migraineurs are less likely to get breast cancer, according to the results of a study published in this month’s Cancer Epidemiology, Biomarkers and Prevention.

In the study, Robert W. Mathes and colleagues at the Fred Hutchinson Cancer Research Center combined information from 2 retrospective, case-control studies involving women between the ages of 55 and 79.

The scientists found that women who gave a history of migraine headaches were one-third less likely to develop breast cancer. The association was limited to hormone receptor-positive tumors. It was not affected by migraine therapy or by the age when migraine headaches began.

The association held for both estrogen- and progesterone-receptor positive tumors, and for the two most common kinds of breast cancer, which are ductal carcinoma and lobular carcinoma.

The scientists speculate that estrogen is the cause of the seemingly odd association.

In women, they write, migraine headaches can be triggered by falling estrogen levels as typically occurs before and during menses. Of equal interest, migraine headaches tend to disappear during pregnancy when hormone levels run high.

The scientists then write, “given that lifetime estrogen exposure is correlated with breast cancer risk, the occurrence of migraines in women, which also has a relationship to estrogen, may be related to breast cancer risk.”

The scientists call for confirmatory studies since theirs is the first to identify the association. It is particularly important to undertake follow-up studies since this study was unable to account for a potential confounding effect of non-steroidal anti-inflammatory drugs like Motrin. These drugs are commonly used to treat migraines and have been linked to a reduced risk of breast cancer.

Heck no, everybody knows Al Gore did that but the Big O’s presidential campaign did leverage the Internet to an unprecedented degree, and he will continue to do so as President.

Obama’s Internet strategy promises to be the biggest change in presidential communications since JFK began using television to take his message to the public half a century ago. In reaching directly to supporters using the Internet, the Big O can bypass the mainstream media any time he wants.

Already the Big O’s www.change.gov  Web site incorporates suggestion forms and a blog, harbingers of the sort of immediate feedback his administration will encourage.

But the centerpiece of Obama’s communication strategy will be his email database, which contains 10 million names. 3.1 million people in that database gave money to his campaign. Millions more volunteered to register new voters, organize those scintillating rallies, garner support from wavering voters and generally help the man become President.

The Big O will be banking on those supporters to lobby congress in support of his initiatives, provide feedback on his policies, and get out the vote for his preferred candidates come the 2010 midterm elections.

Smelling a goldmine, Peter Greenberger, Google’s manager of political advertising suggested that the Big O could combine an ad strategy with his database to recruit support for his policies. “If there’s an article in the New York Times or the Washington Post about health-care legislation,” Greenberger told the Post, “the administration or a pro-Obama advocacy organization could run an ad right alongside it.”

Thanks Pete.

Even some Republicans have taken note.  Recently, several members launched www.rebuildtheparty.com which implores the next party chairman to start an Internet-based organization like the one that helped oust them last week.

“Online organizing is by far the most efficient way to transform our party structures to be able to compete against what is likely to be a $1 billion Obama re-election campaign in 2012,” according to the site.

In each of the 4 years since state legislators banned smoking in restaurants, bars and many workplaces, nearly 600 fewer Massachusetts residents died from heart attacks, according to a report from the state Department of Public Health and the Harvard School of Public Health.

That represents a 30% decline in heart attack deaths, a significant acceleration that was easy to spot amid a gentler, long-term decline reflecting national trends. Officials noted that Boston and surrounding municipalities, which had enacted bans prior to 2004, experienced the steep decline before other areas in the state.

The report explored other possible causes for the drop-off such as improved transportation of heart attack victims to hospitals, medical record coding changes and demographic changes, but there was no evidence they played a role.

“This is the strongest study yet of the effect of smoking bans on heart attacks,” Dr. Michael Siegel told the Boston Globe. Siegel, who had criticized earlier studies of the matter, is an expert on tobacco control programs. “You can no longer argue that these declines would have occurred simply due to medical treatment.”

The findings should impact the debate over secondhand smoke, in which tobacco and hospitality industry lobbyists argue that available data does not support workplace tobacco bans.

It should also further empower the Boston Public Health Commission which had tentatively approved several muscular tobacco control regulations such as ending cigarette sales on college campuses and at drug stores, and closing cigar parlors and hookah bars.

Scientists have known for years that secondhand smoke can adversely affect the cardiovascular system, even if exposure is brief. In particular, such exposure triggers coronary artery spasm, damages coronary artery endothelial cells, and increases the risk of blood clots, all of which can trigger heart attacks.