The "Nanos" Are Coming
Nearly $10 billion is slated for across-the-board nanotech research in 2005; a good portion of these dollars are healthcare-targeted, and for good reason. Nanomedicine, which started to surface a couple of years ago, is now making gigantic strides into a future that is potentially an almost-surreal approach to diagnosis and treatment.
Over sixty nanotech-based drugs and drug delivery systems are currently being tested. Close to 1,000 diagnostic tests and medical devices are also in test. Almost all of the work is still being done in the laboratory or with lab animals; a very, very small number are in early-human-test stage. But things seem ready to take a giant leap into a whole new era of medical miracles.
As a sign of the times, the field has even spawned its own weekly newsletter: NanoBiotech News. Key element in all its news and writings is…think small. Very, very small!
Reportedly many scientists are already targeting coated quantum dots -- small as two billionths of a meter -- of silicon or similar material that can be targeted at the specific molecules the scientists want to track. The "qdots" then insert themselves into these targeted cells and proceed to move about. Ultraviolet light highlights the qdots' coating and tracks them as they move within, in effect giving scientists a clear vision of the inner workings of the cell.
Scientists can coat different-sized qdots with different colors so the scientists can track the movement of a varied number at work within a cell. Qdots and other nano materials have yet to be proven safe for use deep within the living body. Most scientists think that is just a matter of time.
Currently though they are limited to spotting disease in blood or tissue specimens at the earliest of stages. Qdots that are attracted to cancer cells, for example, will therefore quickly identify -- literally "light up"-- these invaders when current tests might well pass them by.
Qdots may be able to directly fight cancer, too. Gold-coated spheres consisting of about 130 nanometers in diameter have been inserted into the bloodstream of lab animals with cancer, they literally burned the tumor to a crisp, without harming surrounding tissue.
Incidentally, 130 nanometers placed on the head of a pin would cover less than .009% of its surface.
Potential uses apparently are almost endless. Nanofibers, for example, could spur neuron growth in injured nerves. Laboratory animals with spinal cord injuries have been treated in this manner and showed a much greater ability to walk again than untreated specimens.
The same was tried for bone injuries….and here too the animals record of recovery was far greater than the normally treated.
A version of nanotechnology seems to be making its way into personal diabetes testing units. Basis of it all are small clusters of imbedded-just-under-the-skin hollow tubes -- each about 1/100,000 the diameter of a human hair -- that, by their intensity of glow, measure the level of blood sugar. Bloodlessly. (More about diabetes on page 2.)
And all of this is in the earliest of stages. Which makes you wonder whether the almost-instant cures and bloodless medicine seen in Sci-Fi movies. Fame may be closer than we ever imagined.
Joining Together to "Eliminate Paper"
Eight giant corporations -- each all-to-often in direct competition with many of the others -- have formed an alliance with the explicit purpose of reducing healthcare costs and hopefully saving some lives by more-quickly switching from paper to digital records. All this accomplished by the rapid-as-possible switch from what they see as today's "fragmented system" to the development of a national health information network that would include patient records, clinical records, research records, claims requests and payment records.
It is obvious that, by their individual size and importance alone, all the sponsors stand to profit from implementation of these recommendations…though they insist that everyone -- caregiver, insurer, patient -- will also benefit. The players are Microsoft, IBM, Hewlett-Packard, Intel, Oracle, Cisco Systems, Accenture and Computer Sciences. Each member has agreed to accept developed software as "nonproprietary", making it available to any and all.
The "alliance" goes by the tongue-twisting name of the Interoperability Consortium. Their recommendations have been submitted to the feds in a detailed 134-page report. To further the non-propriety nature of their plans and systems, the group recommends that HHS establish an oversight National Health Technology Standards Company, which will act as a clearing house and arbitrator of potential competing systems down the road. This organization will also act as a guardian of patient's rights, to both assure that HIPAA standards are guaranteed for all patients...and that no patient's records are included in any future drug studies without individual consent.
Money, of course, plays an important part in this recommendation, which outlines the need for government's strong and necessary role in the development and implementation of this plan. Not money for the consortium…money for hospitals and doctors now working too close to marginal levels to invest in expensive hardware and software. Plus additional incentives at every user level to put in the time and training to learn how to make the system work-as-planned.
Echoing this report, the Bush administration is requesting $125 million in fiscal year 2006 for health information technology related projects. Stated goal at HHS is the establishment of electronic medical records systems across the United States within ten years. Apparently to make the point clear as possible, President Bush has made a number of high-profile visits to hospitals such as the Cleveland Clinic, each time stressing the need for the development and implementation of a cost-effective and user-friendly EMR system in the immediate future. For more on this subject, read about the man behind the fed's drive to make electronic medical records happen soon-as-possible...
David Brailer: Man in Motion
Much in the news these days is the administration's "point man" in what has become a strong and unrelenting effort to make electronic medical records happen across just about every aspect of what is often referred to as a "slow-to-respond" healthcare industry. Doctor David J. Brailer was appointed National Health Information Technology Coordinator last May 6 and doesn't seem to have stopped moving since.
His resume is impressive; most would call it overwhelming. MD from U. of West Virginia, residency at the U. of Pennsylvania, board certified in Internal Medicine. PhD in economics from Penn's Wharton School. Dr. Brailer was the first medical student to serve on the Board of Trustees of the AMA. Until recently he was a Robert Wood Johnson clinical scholar at Penn. He was also the first recipient of the National Library of Medicine Martin Epstein Award for his work in expert systems.
Just prior to his appointment he was a Senior Fellow at the Health Technology Center in San Francisco, consulting on the future impact of high tech in the delivery of healthcare. Along the way, he spent ten years as CEO of CareScience, a multi-dimensional company dedicated to developing more-innovative methods of delivering today's healthcare.
All this at the age of 45 and with his biggest challenge ahead. If he seems to be everywhere all the time, that's because he is. Currently he is digesting the hundreds of system suggestions that have been forwarded in a blanket request issued several months ago. And evaluating the variety of incentives -- federally-backed loans, grants and increased Medicare reimbursements -- that he says will be offered to hospitals and providers as more of them move to electronic medical records. And meeting people, making impassioned speeches, arguing with Congress for increased appropriations.
Dr. Brailer says he realizes that initial changeovers will be slow; but that once system adoption reaches near 50%, IT will prove its point …that you can increase quality-of-care as you reduce the cost-of-care. At that point, he says, both healthcare-delivery and economic thinking will take over and convince everyone this is the right route to go.
RFID Code Use Expanding
Couple of months ago we wrote about a "passive" E-Z Pass-like system that the FDA is actively promoting to help identify counterfeit medicine. "Radio Frequency Identification"; simply called RFID by most.
Now several hospitals in various parts of the country are in the first stages of tests that will use RFID barcodes in a more "pro active" way. The current most-advanced tests are underway at several Boston medical centers using a tracking system that can locate the exact position within the hospital of patients, doctors and many of the sophisticated bits of portable medical equipment moving about at the moment. It's done with small removable tags on the people and permanent tags on the equipment…all of which broadcast signals to ubiquitous wall- mounted receivers tied to the hospital computer's central nervous system. Hopefully, the system will eventually be able to monitor simpler tasks, from targeting patients waiting too long for a procedure or between tests… to perhaps even protecting them from receiving improper medication.
However, many HIPAA advocates are strongly opposed to much of this technology, claiming this is an early step that will eventually lead to total loss of privacy. They paint a picture of personal medical record chips permanently implanted in each patient's arm…with the information someday fed into and stored in a giant database that could be hacked into at will by the devious and crafty.
RFID advocates point out that most patients currently are given the right to refuse to be tagged and monitored in this way during their hospital stay. HIPAA advocates, on the other hand, say that expanded use of the system will greatly lessen a patient's ability to refuse to participate.
New Diabetes Fighter
A cause and effect that researchers have long questioned seems to be proving itself out according to most-preliminary results presented in Nature Medicine by Harvard researchers. If these results bear out in further studies, a powerful but simple new aspirin-like drug will someday be available to fight type 2 diabetes, a disease that afflicts more than 18 million Americans.
Diabetes, of course, is all about insulin, which transports the sugar -- the body's basic fuel -- from blood into cells. Problem is the patient's body can't produce enough of it or can't properly use what is produced. Test results, first with laboratory mice and then with a small number of human patients, seems to directly point to obesity as the culprit. Also seems that excess body fat tends to turn on a "master switch" that causes inflammation in the liver…which seriously interferes with the body's insulin-making abilities. Reduce or eliminate this inflammation and we just may be able to eventually all-but-destroy much of type 2 diabetes.
Generally, inflammation is the body's natural way of healing wounds or infections, but scientists have always known that it can also indirectly be "twisted" to work against the body.
Aspirin was first given as an inflammation fighter; results were acceptable, but several of the side effects -- including intestinal bleeding -- weren't. Now the researchers have found that limited doses of the arthritis drug salsalate seem to work well. The researchers are now requesting additional funds from both the American Diabetes Association and the federal government, which will enable them to launch full-scale studies.
Marginal note. Inflammation has also been associated with several other major classes of illness: heart disease, Alzheimer's and some types of cancer. So the potential for this therapy, somewhere down the line, is tremendous.
NIH: Painful Cure
Elias Zerhoundi, the agency's director, recently brought together hundreds of employees to announce that everyone -- scientists to clericals -- had to divest themselves of anything that could be seen as financial "conflicts of interest". Within 90 days.
For top level people, this included stock holdings in all manner of pharmaceutical and biotech companies; the ruling also applied to their spouses and dependents. Employees with no decision-making power are now limited to individual holdings of $15,000.
Scientists and other top-level employees will be permitted to receive outside "honors" for their breakthrough work -- effectively plaques and trophies -- but no monetary awards. Nobel prizes apparently will remain in a class of one; they may still be accepted.
Director Zerhoundi apologized profusely but said this was an essential first step in restoring the image of total impartiality to the NIH. All of which was met by angry complaints from the attendees, who generally questioned why their one agency was singled out from all others in the government. And also questioned why them? …while outside scientist-consultants, many of which recommend and oversee grants, remain free to invest as they wish.
The 90-day period will be up early in June. Best-guess is that several irreplaceable NIH people are planning changes in career paths around that time.
NIH: Fast Access to Research Reports
Starting next month, scientists whose research is underwritten by the NIH will be asked to release their manuscripts to the general public as soon as possible, but always within twelve months of final publication. The articles will then be made available on a NIH National Library of Medicine website.
The NIH reports that this policy will be voluntary, but monitored. It is hoped, they say, that this will balance the scientific needs of peer review -- which effectively assures the integrity of the research -- with the public's right to know. As the NIH sees it, "general public" first and foremost are patients, families and doctors affected by any particular area of research.
Scientists and others receiving NIH grants are being asked to submit electronic versions of the final manuscripts as soon as it has been cleared by peer review and is scheduled for publication. The NIH says the process will not interfere with publishers' copyrights.
CMS Launches Reimbursement Test
Ten large physician practices have agreed to be monitored over the next three years in a program designed to lower Medicare costs and improve healthcare delivery. Hopefully it will save CMS money, a portion of which will go to the participating physician groups.
The physician groups are pledged to use disease management and health information technology to find efficiencies in care and to improve (a key word in all discussions) patient outcomes while reducing the need of unnecessary services. Some of these selected groups have reported success of similar efforts with their private patients. Most times these efforts have increased the cost of short-term care in order to realize long-term economies; that is why CMS is tracking the program over a three year period.
Almost all the selected physicians' practices have gone on record as saying that today's basically fee-for-service system is deeply flawed and that reform is long overdue…in fairness to patients, doctors and Medicare. That is why they have agreed to go into such a basically uncharted finances-of-care area.
The ten practices were selected from 26 applicants that volunteered to participate in the program. They are located across the country, from Bedford, New Hampshire to Billings, Montana; almost all in the northern half of the country. Closest to us is Geisinger Health System in Danville, Pa.
The AMA has gone on record as firmly supporting the program and plans to produce a position paper on this issue at its next annual meeting.
Expanding Coverage
As you are reading this about 60 major companies are going into the advanced planning mode of a major new effort to introduce an affordable healthcare coverage plan for their uninsured part-time and temporary workers across the country. The actual program is slated to go into operation this fall and will offer enrollment for at least the next two years. The companies will not subsidize the plans but expect that the total power of so many potential participants will sharply reduce individual costs.
Program sponsors include IBM, Sears, GE and McDonald's. Anticipated is that 7% (3 million) of the 45 million uninsured Americans will be eligible to participate. The plans will offer a variety of options. On the low end is a $5 a month "membership card" that will enable the individual to realize discounts at pharmacies and even doctors' offices. At the high end is a high-deductible $300-a-month plan that shields the participant from major medical costs. A number of other "in between" plan options will also be available.
United Healthcare and Humana will be deeply involved in the overall plan, with Cigna limiting itself to a marginal role for the present. Most of the sponsoring companies say they will also make plan membership available to their contractors, consultants and early retirees.
Coding Tips
Coding for Endovascular Ablation Therapy.
Four new codes were added this year to CPT to report endovascular ablation therapy of incompetent veins. The two techniques represented by the new codes are radiofrequency ablation and laser therapy ablation. Treatment of incompetent veins due to disorders such as varicosities or venous insufficiency is often necessary to decrease swelling, pain, and debility associated with venous disorders. The procedure described by new codes 36475 - 36479 include using ultrasound guidance to access the vein (often the greater saphenous vein), and utilizing a radiofrequency probe or laser fiber to treat the incompetent vein.
Endovenous ablation therapy of the first incompetent vein is assigned code 36475, and code 36476 is assigned when second and subsequent veins are treated in a single extremity through a separate access site. Similarly, laser treatment of the first incompetent vein is assigned code 36478, and second and subsequent veins treated in a single extremity through a separate access site are reported utilizing code 36479.
Remember, if other treatment methods are necessary to complete the treatment, such as sclerotherapy (i.e., code 36470) or venous stripping (i.e., code 37720), they should be reported in addition to the endovascular ablation therapy.
Transcription Tips
Anatomic Terms:
Do not capitalize the names of anatomic features, except for eponyms associated with them, i.e. occipital bone, os frontale, ligament of Treitz. Do not capitalize posture-based terms: anterior, posterior, superior, inferior. Do not capitalize region-based terms: cranial, cephalic, caudal, dorsal, ventral.
It is common practice to combine English and Latin anatomic terms, which are transcribed as dictated and not capitalized, i.e. latissimus dorsi, palpebrales arteries, peroneus profundus nerve.
Medical Minutia
The ancient Romans fervently believed in public health service. To their thinking, the prevention of illness was more important than the cure… which after all was controlled by the gods. Therefore they practiced personal cleanliness, while avoiding if possible, bad air, dirty water, and what we might call "contaminated land".
That is why Rome and most of its major cities had aqueducts to bring in clean water, large public baths, plus a system of sewers and public toilets.
The Romans apparently were the first to observe that death rates were highest in and around swampy areas. Temples were often built near these swamps in an effort to pacify their gods.
Auditing the News
Scientists recently announced, in an article in Nature, the discovery of a small number of heart cells that can apparently create new -- and even different -- heart muscle cells, just possibly enabling a damaged heart to treat and heal itself.
These cells are called "progenitor" rather than stem cells because they don't have the ability to multiply indefinitely; so each one is precious. Experiments so far have been limited to lab animals.
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The "Big 3" auto makers, the UAW and Michigan's three largest healthcare insurers have joined forces in an effort to have all their prescription orders handled electronically. The program -- first of its kind -- is called "e-prescribe". The parties involved represent $10 billion in healthcare costs last year alone…due to their coverage of almost two million active workers, retirees and dependents.
Doctors joining the plan reportedly will be offered additional incentives if they use this electronic method when prescribing for their non-UAW patients.
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In an ironic twist of fate, neurologist Dr. Richard Onley, a leader in the fight against ALS (Lou Gehrig's disease) has been stricken with this non-contagious disease.
About 30,000 Americans currently are afflicted; it is estimated that 10,000 cases are diagnosed each year, as the brain cells that control their muscles waste away and die…usually within a year or two.
Several possible treatments are being developed, but the best of them is relatively ineffective, extending a small number of patient's lives by a few months.
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Opening in weeks…Broward County, Florida's Miramar Memorial Hospital, which claims it combines a "homey" atmosphere with a paperless state-of-the-art infrastructure, 128 large private rooms with love seats that unfold into beds for family member stayovers...as well as isolated and sealed rooms that can be used for victims of bio terrorism.
The hospital will be laptop friendly to patients interested in keeping up with the net.
The facility also has twelve labor and delivery rooms in anticipation of 175-plus births a month. Adjacent is a medical office building with space for 100 doctors.
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Newest idea for the "guesstimated 7% to 22%" of the general population that doesn't take their injections or don't take them on time…simply because they really fear the hypodermic needle. Currently, there are over one hundred delivery systems in development, including two most-innovative leaders; a micro-needle mounted on a postage-stamp size patch which just has to be affixed to the skin…and a system that uses low-level electrical currents to deliver local anesthetics. All need further development, including an ultrasound technology that is a bit farther behind but full of promise.
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According to a study in Health Affairs, 1.5 million personal bankruptcies were filed in the United States in 2001 (apparently the most-recent available data). Healthcare-related expenses -- from lack of funds to pay providers (including claims rejections and simple co-pays), to lost income due to sickness -- was reportedly responsible for half of these bankruptcies.
The New Jersey medical bankruptcies total was nearly 24,000…the Pennsylvania estimate was 29,000.
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Two years after McDonald's self-imposed deadline for reducing artery-clogging trans fats in their fries' cooking oil…it still hasn't happened. What has happened so far is that McD agreed to pay $8.5 million to settle two "misleading consumers" lawsuits regarding their level of trans fats.
The company says it will continue to try to reduce these trans fats, but that all efforts to date have failed because changing the fat content of the oil changes the "delicious taste" of the fries.
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Looking for new opportunities in a digital world, Kodak is partnering with IBM in an effort to develop less-expensive and simpler systems and software to manage radiology and related records at smaller hospitals and imaging centers.
Kodak also has recently introduced upgrades to its secure e-mail system for the transmission of medical records.
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Reflecting the thoughts of many in the healthcare field, an obviously-nervous National Committee on Vital and Health Statistics recently asked HHS to look ever-closer at security practices as we move towards implementation of EMR. In their words..."The whole area of security has eluded us for many years."
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