Lab Soft News

Computer-Aided Tissue Analysis; A Major Step Forward with SIVQ

Bruce Friedman — 2012-02-10T08:00:00-05:00

Computer-assisted image analysis will inevitably become a key component of surgical pathology. This prediction of course is predicated on the wide availability of digital pathology files and archives which is still an open issue with regard to primary diagnosis (see: Digital Pathology and the FDA; WSI Systems Called Class III Devices). Such computer analyis is already an important component of digital radiology diagnosis and case review (see: Software for Comparing Changes in Pulmonary Nodule Size on Chest X-Rays). My pathology informatics colleagues at the University of Michigan Medical School, Ulysses Balis and Jason Hipp, have been much in the news lately. They have made great progress in the development of a software tool for increasing the speed and accuracy of histology image analysis (see: U-M led team makes computer-aided tissue analysis better, faster and simpler). Below is an excerpt from the article:

[Dr. Ulysses Balis] ...is demonstrating the extreme flexibility of a software tool aimed at making the detection of abnormalities in cell and tissue samples faster, more accurate and more consistent. In a medical setting...the technique, known as Spatially-Invariant Vector Quantization (SIVQ), can pinpoint cancer cells and other critical features from digital images made from tissue slides. SIVQ isn't limited to any particular area of medicine. It can readily separate calcifications from malignancies in breast tissue samples, search for and count particular cell types in a bone marrow slide, or quickly identify the cherry-red nucleoli of cells associated with Hodgkin's disease, according to findings published in the Journal of Pathology Informatics. "The fact that the algorithm operates effortlessly across domains and length scales, while requiring minimal user training, sets it apart from conventional approaches to image analysis," Balis says. The technology...differs from conventional pattern recognition software by basing its core search on a series of concentric, pattern-matching rings, rather than the more typical rectangular or square blocks....Still, pathologists shouldn't be worried that SIVQ will put them out of a job. "No one is talking about replacing pathologists," Balis says. "But working in tandem with this technology, the hope is that they will be able to achieve a higher overall level of performance."

SIVQ can also be used with laser capture microdissection as emphasized in the recent article by Balis and Hipp with co-authors (see: SIVQ-aided laser capture microdissection: A tool for high-throughput expression profiling). For more information, point your browser to their Digital Slide Repository.

The End of Health Insurance Companies by 2020?

Bruce Friedman — 2012-02-08T08:00:00-05:00

Here's a bold prediction from a national expert on healthcare strategies, Ezekiel Emanuel, who predicts that the health insurance companies will be replaced by ACOs by 2020 (see: The End of Health Insurance Companies). I don't totally agree with analysis but first read what he has to say in the following excerpt:

Already, most insurance companies barely function as insurers. Most non-elderly Americans...work for companies that are self-insured. In these cases it is the employer, not the insurance company, that assumes most of the risk of paying for the medical care of employees and their families. All that insurance companies do is process billing claims. For individuals and small businesses, health insurance companies usually do provide insurance; they take a premium and assume financial responsibility for paying the bills. But the amount of risk sharing that is accomplished is limited because the insurers charge premiums that vary, depending on the health of an individual or a group of employees, and use their data and market power to identify healthy people to cover and unhealthy people to exclude from coverage....But thanks to the accountable care organizations [ACOs] provided for by the health care reform act, a new system is on its way, one that will make insurance companies unnecessary.

Accountable care organizations will increase coordination of patient’s care and shift the focus of medicine away from treating sickness and toward keeping people healthy....In addition to providing better and more efficient care, A.C.O.’s will also make health insurers superfluous. Because they will each be responsible for a large group of patients...they will pool the risk of patients who have higher-than-average costs with those with lower costs. And with the end of fee-for-service payments, insurance companies will no longer be needed to handle complicated billing and claims processing, nor will they need to be paid a fee for doing so. Payments can flow directly from an employer, Medicare or Medicaid to the accountable care organizations. A.C.O.’s will require enhanced information systems to track patients and figure out how to deliver more effective care, but this analytic capacity will be directed at improving health outcomes, not at imposing barriers to those seeking treatment.

I agree with most of what Emanuel says but differ on one significant point. Hospitals and hospital executives did not invent ACOs. They were not pining away for some new business model when the ACO idea was launched as part of the healthcare reform legislation. Most seemed to be happy with the existing business model under which they manage hospital revenue from the various payers of which the federal government and health insurance companies are the major players. In my opinion, they have little interest in "keeping people healthy" although they frequently pay lip service to the idea. They are in the business of treating disease in hospitals and maximizing their bottom line. Their dialogue with payers is roughly the following, as I see it: tell us what hoops you want us to jump through in order to be maximally reimbursed. The newest hoop, as part of healthcare reform, is the creation of ACOs. The development of these organizations is not the result of hospital executives yearning to be more entrepreneurial and wishing to supplant the health insurance companies.

I can't argue with Emmanuel's premise that "A.C.O.’s will also make health insurers superfluous." This scenario is very possible. My disagreement is that hospital executives will be anxious to assume a new set of responsibilities. In my opinion, they don't want to process billing claims and they don't want to be responsible for "improving health outcomes." To the extent that these duties will be urged or required of ACOs by the federal government, I think that the hospital executives will turn to external service organizations and consultants to achieve this goal (see: Hospital Executives Search for the Formula for an Accountable Care Organization). And who will be in charge of these external service organizations? Probably the current executives of health insurance companies or the healthcare consultants who helped the hospitals create the ACOs in the first place.

Practice Fusion Supported by Advertising and Owns Anonymized Data

Bruce Friedman — 2012-02-07T08:12:06-05:00

In my blog note yesterday, I suggested that physicians might consider Practice Fusion as an alternative to Care360 for their office EMR (see: Quest Diagnostics Offers Reduced Price for Deployment of Care360). Luckily, a reader named Sam submitted a comment about a "catch" associated with this latter product. Here is his comment:

...Practice Fusion...has the same issues as Epocrates in that is it supported by ads (unless you pay the $100/mo/provider to remove them). Practice Fusion goes a step further and takes ownership of the anonymized patient records which it in turn sells. See: [Why Peter Thiel Likes Electronic Health Record Provider Practice Fusion]:

Thanks, Sam, for your useful new information. Here's a relevant quote from the Forbes article cited at the end of his comment:

...[D]octors started signing up [for the free Practice Fusion] in droves. [Founder and CEO] Howard says he has 90,000 users—which he defines as physician, nurse or even the office secretary; and a database of 12 million patients, which he claims is bigger than the VA’s and Kaiser Permanente’s. Howard’s pitch: Doctors can get an EHR without paying a cent and pocket the entire $44,000 government check—which is what they stand to get if they comply with the meaningful use rules. In contrast, an EHR for Practice Fusion’s market of nine or less doctors can cost $50,000 per user. But nothing is really quite free, and Practice Fusion needs to find a way to make money. In the fine print of its licensing agreement, there’s a provision which says that by signing on, doctors agree to transfer their ownership of patient data, stripped of identifiers, to the company. Practice Fusion now sits on a valuable load of information that pharmaceutical companies would love to get their hands on to mine it....I ask Howard whether he plans to sell useful marketing information to a company that wants to know, say, in which parts of the country its newly-released drug is not being prescribed. He balks; he wants to make sure he’s not crossing any ethical lines. He’s looking instead at applications, such as helping pharma companies enroll patients in clinical trials, or monitoring a drug following its release on the market. Practice Fusion’s revenues which are now less than $10 million, come mostly from advertising.

Quest Diagnostics Offers Reduced Price for Deployment of Care360

Bruce Friedman — 2012-02-06T07:37:06-05:00

Here's a recent and interesting blog note regarding a discount offer for physicians to install the Quest office EMR called Care360 (see: Quest Diagnostics Offers Big Discount On Its EMR-Practice Management System). I discussed this product six years ago, which at that time was called a lab portal (see: Quest Software Heats Up the Lab Portal Wars). Below is an excerpt from the current note.

...Quest Diagnostics has kicked off a program offering medical practices a steep 85 percent discount off of the retail price of its Care360 EMR and practice management bundle....The deal, which reduces the physicians’ out of pocket cost to less than $100 per month, also includes training, hosting, maintenance and 24/7 support for Care360. The lab giant says physicians can get Care360 up and running in about 45 days....[I]f I were a doctor I’d think long and hard before agreeing to a deal like this, even though the software is just about free. There’s simply too much at stake to plunge in. Yes, Care360 is CCHIT certified and, intriguingly, has incorporated the Direct Project specs allowing doctors to share information with patients and hospitals. And yes, it seems to have made efforts to support EMR access via mobile devices. This is all good. And of course, the price is right. On the other hand, I’m not sure I’d want to make this big of a commitment to any particular service provider, be it a reference lab, a radiology provider or the people who stock my vending machines with sodas. I’d argue that the more important the service is, the less you want to be beholden to the vendor. After all,what if Care360 isn’t your cup of tea? Do you really want to disrupt your relationship with a critical provider like Quest? Not only that, it’s risky to lock in an EMR just because it’s cheap. If Care360 takes 45 days to get installed, it’s not going to be possible to uninstall it in a day or two, and that could mean misery on wheels if the product doesn’t work for you. Besides, it’s possible to get Web-based, easy to adopt or drop EMRs for only a couple hundred dollars a month more. It wouldn’t make sense to go for an EMR that might not work just to save that little. (If your margin is tight enough that a savings of $200 or $300 a month is critical, you have worse problems than finding the right EMR!)

There is an old saying in healthcare software -- free (or almost free) software is never worth the price. The reason that such a product is usually not "free" is that there is some catch that enables the free or discounted offer. The situation also reminds me of my recent note about the Epocrates office EMR (see: Ethical Questions Raised about the New Physician Office EMR from Epocrates). In this latter case, the EMR displays advertising from pharmaceutical companies. Here's what I had to say at that time:

Very distressing to me, however, is the clear link of [Epocrates] and its software to the pharmaceutical industry. I have blogged on numerous occasions about some of the ethical and legal lapses of some of these companies....I have also reluctantly come to the conclusion that even apparently trivial advertising connections to Big Pharma can lead to mischief. I had previously thought that inconspicuous advertisements in EMRs by drug companies might be tolerated if the companies were to bear the costs of these systems. I now believe that allowing these companies even a tangential relationship to physician-office electronic medical records is too risky.

In the case of Care360, the potential risk, as the first quote above states, is "getting in bed" with the largest reference lab in the U.S. Such a relationship may potentially give Quest Diagnostics some edge regarding the reference lab business of the medical practice in question. Also and as discussed above, it's "possible to get Web-based, easy to adopt or drop EMRs for only a couple hundred dollars a month more." I am sure that the author had in mind systems like Practice Fusion, although I can't speak with authority about its relative functionality (see: Practice Fusion CEO Calls His Company the Largest EMR Provider).

Besides, it’s possible to get Web-based, easy to adopt or drop EMRs for only a couple hundred dollars a month more.

Highest Rate for Testicular Cancer and Mortality in Chile

Bruce Friedman — 2012-02-03T09:36:26-05:00

Here's an interesting observation. Chile ranks first in the world for deaths from testicular cancer, according to the World Health Organization (WHO) and Chile’s Ministry of Health (see: Highest death rates for testicular cancer found in Chile). Read on, if you are interested, in the following excerpt from the article:

In 2009, 121 Chilean men died from the disease and 63 of those were 15 to 30 years old, the age group most at risk from the disease. In the U.K., however, where the population is three and a half times the size of Chile, there were only 70 deaths from testicular cancer in 2008, according to the Cancer Research U.K.’s figures. “Testicular cancer figures are low in Chile in relation to the other types of cancers found here, but yes, the figures are high in comparison with the rest of the world,” [said a cancer specialist ].....Testicular cancer has a 95 percent cure rate if caught and treated in time. Such treatments have been available in Chile for over two decades. Cancer experts in Chile recognize that the country has an unusually high rate of testicular cancer, but no one is sure why. “Less than 5 percent of cases can be explained by exclusively genetic or hereditary causes,” [according to a Chilean urologist] “Neighboring countries with the same ‘culture’ have much lower reported mortality rates from the disease than in Chile,” [according to a cancer expert]. [Another cancer expert offered]...a different theory altogether. “This is only a theory and I have no evidence to support this but there’s a lot of natural contamination of water in Chile, by various metals especially arsenic, and perhaps this could have something to do with the high numbers of cases,” he said. “Really, though, no one knows for sure.”

Heavy metal exposure as a possible etiology seems to be a stretch for me. It occurred to me, however, that an infectious etiology might be possible. There was not much current work on this idea but I did find one abstract that draws an epidemiological parallel between testicular cancer and Hodgkin's disease among young males (see: (see: Viral etiology of testicular tumors). Here is an excerpt from the abstract from this older article:

Testicular carcinoma and Hodgkin's disease are among the most frequent malignancies afflicting young men in the 15 to 39-year age group. These malignancies share other epidemiological characteristics as well, including multiple histological tumor types, higher rates of occurrence in white, urbanized populations and upper social classes, relative infrequency among black populations, low but definite familial occurrence and an early geographically acquired lifetime risk irrespective of later migration. Both diseases are increasing in this country. This epidemiological similarity suggests exposure to an infectious agent early in life. The Epstein-Barr virus is known to be oncogenic and neonatal exposure with early infection is believed to be associated with Burkitt's lymphoma in African children. High titers of antibodies to the Epstein-Barr virus capsid antigen also have been reported in a series of studies comparing patients with Hodgkin's disease and controls. Because testicular cancer is epidemiologically similar to Hodgkin's disease and, therefore, might be expected to manifest similar Epstein-Barr virus findings, we performed a viral screen (Epstein-Barr virus, cytomegalovirus, and hepatitis A and B viruses) on blood samples from 56 consecutive patients with clinical stage I germ cell tumors of the testis who had received no active therapy after orchiectomy. Our results show a high incidence (80 per cent) of previous exposure to Epstein-Barr virus and support the hypothesis of a possible infectious origin for testicular carcinoma.

The problem with this theory is that it doesn't explain the lower incidence for testicular cancer in culturally similar neighboring countries where the males would presumably be exposed to similar viruses. I suppose there is also the possibility of some sort of anomaly of cancer data collection or diagnosis in Chile.

Hospital Website Smackdown: Mayo Clinic versus Cleveland Clinic

Bruce Friedman — 2012-02-02T11:14:41-05:00

I knew that this time would ultimately arrive but we appear to be there now. Two prestigious hospitals are being compared on the basis of the quality of their web sites. A recent article posits a web site smackdown between Mayo Clinic and Cleveland Clinic (see: Website Smackdown: Mayo Clinic vs. Cleveland Clinic). Following is an excerpt of the article:

In this week's Website Smackdown, I’m taking a look at the websites for two of the biggest hospital complexes in the world, the Mayo Clinic and the Cleveland Clinic....The Mayo Clinic and Cleveland Clinic rank neck and neck (third and fourth respectively) on US News & World Report’s Honor Roll of Best Hospitals, but there’s a huge difference in the quality of their websites.

(1) Most people coming to the website for a major hospital have health-related questions, require immediate need for a doctor, or need information about visiting (directions, visiting hours, etc.). Just as hospitals are in the business of patient care, their websites should reflect that same level of care for site visitors....(2) Now take a look how each site handles the critical area of “Health Information.”....(3) Finally, let’s look at one more service provided by both websites: Find a Doctor....

So what can you learn from these hospital websites?

Know your target audience and know why they are coming to your site.

Prioritize your navigation to serve the biggest needs of your visitors.

Make sure you have powerful calls to action and prominent contact information.

Emphasize customer service!

In order not to keep you in suspense if you have not read the original article, the Cleveland Clinic has won this particular competition in the three stated categories. The author of the note supports his conclusion with screen-cap images of the web pages for the two hospitals. The secret of the quality of the Cleveland Clinic web site does not involve any magic and is based on the bulleted points listed at the end of the excerpt above: (1) understand the mind of the patient; (2) prioritize web site navigation; and (3) emphasize contact information and customer service.

Hmmm. Trying to understand the mind of the patient browsing a hospital web site. Sounds simple enough, doesn't it? However, I suspect that this might be a difficult task for some hospital executives and healthcare professionals such as nurses and doctors. The reason for this: many of us are so immersed in our professional disciplines and the complexities of healthcare delivery that it's hard to think as patients do.

Let me give you one practical example of this. Many years ago, I discovered that a prestigious hospital had located its neurology clinic next to its neurosurgery clinic and its cardiology clinic next to its cardiac surgery clinic. Wait a minute! That makes no sense. The specialties of cardiology and neurology are part of internal medicine -- they belong on the internal medicine floor of the clinic building, don't they. This clinic design approach makes sense to patients who tend to think more about organ systems and not the way that medical disciplines have evolved and are organized.

Clinical Labs Have Much to Learn from the Genetic Testing Web Sites

Bruce Friedman — 2012-01-31T13:36:33-05:00

The clinical labs have much to learn about genetic web sites such as 23andme and ancestry.com (see: FDA Cracks Down on Consumer-Oriented Genetic Testing Web Sites; 23andMe Builds Online Sarcoma Research Community). This latter company is extending their genealogy business model into genetic testing.

I was trying recently to better understand the pricing options offered by 23andme and sent a query to their help desk about this topic. I got the following explanation back from the company. It provides some useful insights about the company and its future direction:

The 23andMe Personal Genome Service is a genotyping analysis of about one million SNPs resulting in interpreted data for both your genetic ancestry as well as your genetic disease risks and traits. There are three pricing options available to suit your individual budget:

$99 upfront plus $9 per month subscription with a 12 month commitment. Your credit card is kept on file within your account and the subscription will automatically revert to a month-to-month billing after the 12 months are completed. If you wish to cancel after the 12 months, you must notify us by sending an email to help@23andme.com
$207 - this is $99 plus the 12 month commitment paid in full (12 x $9 = $108). No credit card is kept on file. After your 12 months, you may continue your subscription, if you wish, by adding a credit card to your account for future billing.
$399 - this is a one-time, flat fee which will cover all ongoing updates applicable to the current genotyping platform*. No credit card is kept on file. No subscription service or fees.

*The $399 price will cover all ongoing updates applicable to the current genotyping platform. So when you hear or read about "lifetime" what that means is the lifetime of the genotyping platform, not your lifetime.

Here are a few of my observations derived from this reply including some ideas about future directions for hospital-based clinical labs:

Note first that the company is testing for "about one million SNPs" but seems to be preparing to shift at some future time to whole genome scanning as its "genotyping platform." Hence the clarification that the $399 fee only covers "all ongoing updates applicable to the current genotyping platform." Whole genome scanning will undoubtedly be more expensive than the current SNP analysis and the company does not want customers "grandfathered" automatically to this new platform.
Secondly, the business model of the company covers testing of the current specimen and also a subscription to the web site. Customers obtain interpreted data about their genetic ancestry at the site as well as information about personal genetic disease risks and traits. The relationship with customers is thus maintained beyond the initial testing phase.
Thirdly, the benefit to clients increases as the size of the company's proprietary genetic database increases. Also and because of economies of scale, the cost of SNP testing, and, ultimately, whole genome scanning, can only decrease over time. This, of course, makes the service more attractive to potential clients in the future.
I envision the following lessons for hospital-based labs based on these observations: (1) the need to shift, in part, from the current physician-centric model to more of a patient-centric model; (2) hospital patients could also be shifted to a subscriber model such that they, or their treating physician, could be informed about new medical discoveries or treatments relating to their disease status and genetic profile; and (3) all of these changes will require functionality far beyond those provided by our current LIS capabilities (see: The -Omics Cloud: A Healthcare IT Solution Already Developed for Genomics Research).

An estimated 7% of Population Carry Oral HPV; Oral Cancer Incidence to Rise Sharply

Bruce Friedman — 2012-01-30T10:45:09-05:00

In a previous post, I raised the issue of the relationship between oral sex, HPV, and oral cancer (see: HPV Now Shown to Cause Oral Cancer in Men). Here are two quotes from it:

The HPV virus now causes as many cancers of the upper throat as tobacco and alcohol, probably due both to an increase in oral sex and the decline in smoking.

Of the 300 study participants [in a recently published study], those infected with HPV were also 32 times more likely to develop [cancer of the tonsils or at the base of the tongue] than those who did not have the virus. These findings dwarf the increased risk of developing this so-called oropharyngeal cancer associated with the two major risk factors: smoking (3 times greater) or drinking (2.5 times greater). HPV infection drives cancerous growth, as it is widely understood to do in the cervix. But unlike cervical cancer, this type of oral cancer is more prevalent in men.

Now comes more information about the incidence of oral HPV in the U.S. population (see: 7% of adults, teens carry HPV in mouths):

An estimated 7 percent of American teens and adults carry the human papilloma virus in their mouths, an infection that puts them at heightened risk of developing cancer of the mouth and throat, researchers said Thursday. Their study, the first to assess the prevalence of oral HPV infection in the U.S. population, may help health experts understand why rates of oropharyngeal cancer - a type of head and neck cancer - have skyrocketed in recent years, increasing 225 percent between 1988 and 2004. The findings also indicate that the virus is not likely to spread through kissing or casual contact and that most cases of oral HPV can be traced to oral sex.... If present trends continue, HPV will cause more cases of oral cancers than cervical cancer by 2020, according to the ....study. HPV infection is common - an estimated 80 percent of Americans have contracted the virus....It usually produces no symptoms and is typically cleared from the body through natural processes. But persistent infections can cause cancer. Vaccines are now available for children and young adults to prevent cervical and anal cancers caused by the most troublesome HPV strains.

Here's a very current reference about the relationship between oral HPV infection and oral cancer (see: Human Papillomavirus and Rising Oropharyngeal Cancer Incidence in the United States). The conclusion of this article is clear:

Increases in the population-level incidence and survival of oropharyngeal cancers in the United States since 1984 are caused by HPV infection.

It was as a matter of some debate when the HPV vaccine came to market whether both males and females needs to be vaccinated. Now and with the threat of oral cancer associated with HPV infection, there is a need for additional discussion and research about the use of the vaccine to prevent oropharangeal cancer, particularly in males. However, it seems that there is controversy, not unexpectedly, about this topic (see: Oral Sex, Throat Cancer And HPV Vaccines). This note raises the question of whether this emerging research on HPV and oral cancer may be funded by pharmaceutical companies anxious to stimulate the sales of HPV vaccines. There is also the need for clinical trials to determine whether the vaccines prevent oral cancers.

Digital Pathology and the FDA; WSI Systems Called Class III Devices

Bruce Friedman — 2012-01-27T12:14:51-05:00

CAP Today has just published what I consider to be the definitive article on the latest ruling by the FDA on digital pathology (see: Regulators scanning the digital scanners). It was written by Karen Titus. Here's an excerpt from the lead paragraphs:

A recent panel on whole-slide imaging launched a clear message from the Food and Drug Administration: The agency views WSI systems as Class III medical devices and plans to regulate them as such....While the FDA’s decision was clear, the next steps are anything but. Vendors, pathologists, the FDA, and the Centers for Medicare and Medicaid Services could head in any number of directions next, but they won’t be moving swiftly....Depending on one’s view, the news will slow efforts to bring WSI for primary diagnosis into U.S. laboratories, with some vendors looking to Europe for regulatory relief; have virtually no impact on large vendors, who, while not necessarily enamored of the FDA’s decision, concede it’s one they can live with; kill the market completely; choke innovation among vendors, especially component makers; possibly put laboratories in jeopardy if they try to validate these systems as laboratory-developed tests under CLIA; or encourage laboratories to use WSI for other, already approved purposes, readying themselves for the inevitable day when whole-slide imaging transforms surgical pathology. What most agree on is that for the first time, the FDA, which regulates the vendor portion of the vendor-laboratory equation, has “put a stake in the sand regarding digital pathology,” says David Wilbur, MD, professor of pathology, Harvard Medical School, and chair, CAP Technology Assessment Committee.

I tend to favor more the "stake in the heart" than the "stake in the sand" view. While the speciality of radiology is enjoying the benefits of nearly total digital conversion (see: Software for Comparing Changes in Pulmonary Nodule Size on Chest X-Rays), pathology will be muddling along for perhaps five years without the benefits of digital pathology such as image portability and the development of large image archives.

Keith Kaplan, who blogs over at the Digital Pathology Blog, has made his views on this issue quite clear. In his recent blog note, he cleverly copies Karen's article form CAP Today and then embellishes it with his own tropes in boldface (see: Regulators regulating digital scanners). I suggest that you turn first to Keith's blog to get a "twofer" -- the CAP Today article plus Keith's funny and insightful comments. He treads where the CAP would not venture. Here is the way he launches his note:

The FDA has about 1 million pages that are surprisingly easy to navigate on their website including a "How to Classify Your Device Page". If I am reading this correctly, microscopes are Class I devices, as are colposcopes to diagnose cervical dysplasia and cancer, [and] ditto for stethoscopes [and] holders for artificial heart valves....(roman numerals should only be used for really important things like Super Bowls).....Defibrillators...are Class 2! 360 joules of energy that could save your life in a moment or cause death if you do not respond to the TV "CLEAR!". And a slide scanner is Class 3 because? Oh, image quality, right. Apparently the FDA didn't look through the microscope I used today. It was like rice crispies were stuck to the lenses.

By classifying slides scanners as Class III devices, the FDA completely ignores the interposition of the highly-trained brain of the pathologist between the screen image and the dictated report that is sent to the clinician. As Keith points out and according to the FDA, a malfunctioning defibrillator, a Class II device, apparently does not pose as serious a threat to life and limb as a whole slide image scan.

To achieve some balance in this note, I need to add that some significant minority of pathologists may be cheering for the FDA on the sidelines. The introduction of digital pathology for primary diagnosis will require a large capital investment and a significant amount of retraining on their part. However, the majority of our ancestors might have voted down the wheel if they has been asked for their opinion at the time. Too many shell necklaces and too much ox-cart-retraining required.

I guess that I can continue to use my classic example of pathologist foreplay for a while: "Please pass me the next slide."

Software for Comparing Changes in Pulmonary Nodule Size on Chest X-Rays

Bruce Friedman — 2012-01-26T09:25:23-05:00

Most healthcare consumers are familiar with the new digital imaging modalities such as CT, MRI, and PET scans. However, fewer may be aware of the image analysis software that is in common use for analyzing digital images in radiology. A recent article was fascinating for me in terms of cost-saving and quality opportunities that are being made available by such software, even for the common chest x-rays (see: FDA Approves New Chest X-Ray Scanning Software). Below is an excerpt from the article:

Software that could lead to low-cost early detection of lung cancer won US Food and Drug Administration (FDA) clearance this month....Development of an inexpensive tool for early diagnosis could have a tremendous effect on cancer screening and disease survival, said [a radiation oncologist]. The new Temporal Comparison software helps radiologists better detect changes in lung tissue by improving comparisons between a new chest X-ray and one taken previously, according to a company news release. The software superimposes the new image on the old one and highlights areas of change, using pattern-recognition and machine-learning algorithms. Normally, radiologists draw conclusions about suspicious tissue changes by conducting side-by-side X-ray comparisons....Detection scores of solitary nodules improved 12.4% with the new software...However, widespread application of CT scanning [which are deemed to be superior to chest x-ray screening] has been stymied by the costs of the testing, which insurance companies are reluctant to reimburse without a prior diagnosis....[The Temporal Comparison] software would be "an order of magnitude" cheaper than CT scanning. However, ...there is a trade-off, because a CT scan provides a 3-dimensional view that an X-ray cannot....[A] single server with the new software could serve all of a facility's X-ray equipment. [The x-ray scans] go directly to the server, which searches the facility's picture archive and communication [PACS] system for prior scans. If a prior scan exists, the [two] X-rays are aligned and the difference image goes into the patient file....."If you could use a standard chest X-ray and some new algorithm to diagnose patients earlier, that's a gold mine for the patients," [an expert in the field] concluded.

There are several aspects of this news that are interesting. First of all, the Temporal Comparison software now takes on the burden of some of the professional responsibility of the radiologist. As noted above, "the software superimposes the new image [of a nodule in the lungs] on the old [x-ray image of a nodule] and highlights areas of change, using pattern-recognition and machine-learning algorithms." The comparison of a current image with priors for a patient has been the responsibility of the interpreting radiologist. Secondly, this new software seems to give new life and significance to garden-variety chest x-rays that are deemed inferior to CT scans but for which insurance companies have been reluctant to reimburse absent a prior diagnosis. This must be one of the reasons that the FDA has provided clearance for this new software. It would seem to result in better and more cost effective care.

Finally, the availability of this software makes a compelling argument for the development of larger and larger radiology image archives, beginning with all hospitals within a health system and moving to the cloud-sharing of radiology images across referring hospitals in a region. Here's an excerpt from an article that points in this direction (see: Memorial Hermann to Employ Cutting-Edge Radiology Image Management and Sharing Platform):

In a move that expands its technological capabilities and further differentiates Memorial Hermann as an innovative leader in the greater Houston area, the hospital system has implemented a cutting-edge, cloud-based medical image sharing platform that vastly enhances image management, distribution and data exchanges between referring physicians and hospitals in southeast Texas.... Powered by DICOM Grid, provider of a cloud-based platform for medical imaging management applications, the technology greatly increases the quality of care, patient safety and business continuity between Memorial Hermann’s hospitals, Imaging Centers, affiliated physicians and other providers in the community. Memorial Hermann’s enterprise-wide technology initiative improves service and promotes tighter integration with facilities that refer patients to its Level One trauma center and physicians that utilize any of the 28 Memorial Hermann Imaging Centers. “DICOM Grid eliminates the need for CDs and traditional radiology film because authorized facilities can now easily and instantly transmit images to our Level One trauma center or receive radiology studies from our Imaging Centers, including MRI and CT scans, via the system,” said [the CIO] at Memorial Hermann.

The Next Step in the Development of Personalized E-Newspapers

Bruce Friedman — 2012-01-23T12:41:28-05:00

In previous posts, I have discussed both Flipboard and Zite (see: Blogs Becoming Increasingly Popular and Blending with Other Media; Zite Receives Cease-and-Desist Letter from Big Media). Both apps serve as examples of how the much-anticipated, personalized, e-newspaper will evolve. Note that CNN understands this strategic direction, as exemplified by its purchase of Zite (CNN Buys Zite and Pursues Big Screen, Small Screen Media Strategy. This evolutionary process goes on unabated. Twitter, a key player in the shift to e-newspapers has purchased startup Summify (see: The Startup That Could Turn Twitter Into Your Newspaper). Below is an excerpt from this article:

Twitter ]has] purchased the small Vancouver startup Summify..., but it could be a big step for the company's value as a news source. Summify created a service that would send you the "top news" from your social networks based on a proprietary algorithm that combined your interests with the most popular links among the people you follow on Twitter, say. It took some of the anxiety out of knowing that you could never possibly read every tweet from a large network. To appreciate why it matters that Twitter acquired Summify, you should try linking your Twitter account to Flipboard. Flipboard takes the links that my Twitter connections post and turns them into a magazine-style digest. Every morning, when I want to see what's happening, I don't fire up Twitter itself and cruise through hundreds of tweets. Instead, I fire up Flipboard and see right through the 140-character tweets to the vast sea of information on which they rest. This is an immensely useful way of dealing with large amounts of tweets. An even more impressive service is Nieman Journalism Lab's "Fuego," which ranks the links that people who are interested in the future of journalism are tweeting....If I think about what Twitter might do with Summify, it's pretty simple: Flipboard + Fuego. Basically, it's a personal "trending topics" generator. Take the hottest links from your feed drawing on Twitter's rich data, combine them with your personal preferences, and present them in some nice format. Perhaps this format could be a (very monetizable) daily newsletter filled with news and information that's relevant to you. If we were anachronistic, we might even call this bundle of content a "newspaper" that just happens to be curated by your Twitter network.

Both Fliboard and Zite create personalized e-newspapers that can be read on your smart phone or iPad. The former allows you to list your favorite social media or web sites with the app. The latter, with your permission, assesses your news, blog, and social media preferences by scanning your news consolidator preferences (e.g., Google Reader) and then provides a personalized e-newspaper on this basis. Summify continues this process by the use of a proprietary algorithm, culling and presenting news to on the basis of your Twitter personal preferences and trending topics. What all of these processes have in common is the opportunity to tap into your personal news and information preferences and then present the news that you prefer on your big or small screens (e.g., PC, tablet, or smart phone).

Genomics-Based EHR: Is This a Realistic Expectation?

Bruce Friedman — 2012-01-20T11:50:21-05:00

Although I generally agree with what John Lynn posts on his blog over at EMR and EHR, one of his recent posts caused me to wince a little bit (see: Genomics Based EHR). He raises the issue of the "smart EMR" with genomic data as one its "core elements". Here's his note:

Genomics is one of the core elements that I think a “Smart EMR” will be required to have in the future. I really feel that the future of patient care will require some sort of interaction with genomic data and that will only be able to be done with a computer and likely an EHR....As I think about genomics interacting with EHR data and the benefits that could provide healthcare going forward, I realize that at some point doctors won’t have any choice but to adopt an EHR software. It will eventually be like a doctor saying they don’t want to use a blood pressure cuff since they don’t like technology.

First, some history. I was part of a panel discussion with one of the pioneers of the HIS (hospital information system), a precursor to the EMR/EHR, more than two decades ago. He predicted that the LIS would soon disappear, along with other "ancillary systems," and be replaced by a single, monolithic hospital-based information system. LISs have certainly not gone away during these years away and have now been joined by RISs, PACSs, CVISs, and other specialized clinical information systems. In fact, they have persisted and evolved because their functionality was required by physicians. There is no question that the EMR/EHR will get smarter as rules-based logic becomes a more important part of its repertoire. However, I believe that its role vis-a-vis genomic data will be mainly as a reporting engine.

Along these same lines, I also have significant doubts that the LIS will be the primary storage and analytic engine for genomic data. If not the LIS, then what will replace it within the hospital IT environment. In a previous post, I suggested that the -omics cloud will be required to provide the analysis, storage, and reporting of genomic data (see: The -Omics Cloud: A Healthcare IT Solution Already Developed for Genomics Research). I copy from that note the conclusions I reached in this earlier communication which I continue to think are valid:

We are at an evolutionary dead-end with our current EMR technology. Hospitals will happily pay tens, if not hundreds, of millions of dollars to use old technology designed to mimic the traditional paper medical record.
All of these EMRs are transaction-based with little "intelligence" and even less ability to integrate and analyze the deluge of patient data generated by the EMRs and their "feeder" systems such as the LIS.
LISs are highly functional -- pathology and the clinical labs would be unable to function for a day without them. Nevertheless, LISs vendors are not keeping up with the development of modules that can support the exploding -omics science.
It is highly unlikely that many of the incumbent EMR and LIS vendors will be able to jump to a new generation of analytic healthcare information systems. They are too tied to their current technology, current business models, and their need to recover their sunk development costs.
In my opinion, most of the progress in cutting-edge healthcare computing will be generated in academic research labs, [and] non-profit biomedical research institutes....

So where does all of this leave us? My view for the future of healthcare IT is that it will evolve into a network of highly specialized servers, some in the cloud, with hospital physicians interacting primarily with the EMR for reporting purposes. The field of genomics is moving so rapidly that an EMR vendor would be unable to keep abreast of the underlying science necessary to support workers in the field. So what will be the role and function of the "smart EMR." It will serve mainly to manage the deluge of data fed to it by the network of hospital computers, including the diagnostic systems, and present them in an orderly fashion to the physicians responsible for optimal patient care.

More on Epic's (Non)-Interoperability and the Recent NYT Puff Piece

Bruce Friedman — 2012-01-19T08:09:28-05:00

I was convinced that Milt Freudenheim's glowing, uncritical puff-piece about Epic in the NYT would not provoke any critical blow-back (see: Digitizing Health Records, Before It Was Cool). I was certainly not expecting any criticism from hospital CIOs and CEOs who are anxious to stay within the good graces of the company and are contractually constrained from any visceral outbursts. However, Vince Kuraitis, who blogs over at e-CareManagement, has informed me via a comment that there is a heated discussion going on at Google+ about the NYT article and Epic in general. You may also want to refer to my recent blog note about Epic (non)-interoperability (see: A Reader Comments on Epic Interoperability and Care Everywhere). Here is Vince's comment:

FYI, there is heated discussion going on about Epic (non)-interoperability on Brian Ahier's Google+ post.

Here are five snippets from the ongoing Google+ dialogue selected on a semi-random basis:

It's almost as if Milt Freudenheim avoided doing any research. It borders on contradicting anything that people who are actually work with Epic, as a company or as part of their workflow, will tell you about their experience. I know that Epic has their fanboys and girls, but come on... Really? (Nathan DiNiro)
The article says it draws programmers that might otherwise take jobs at Google, Microsoft or Facebook. I can't imagine there are many of those. Let's see, work on MUMPS in Wisconsin or some newer technology in the Bay area. Yeah, I'm not seeing many making that choice. I also love that it says that Epic is sharing data with other systems. I'd love to see examples of this. I hear that Epic will have a spot in the interoperability showcase at HIMSS. Maybe we'll find out more there. (John Lynn)
I was going to write a post but apart from all the good things about Epic, the [four] things Milt Freudenheim doesn't know that would have made a balanced article
- Technology is old and laughable outside HC (MUMPS or Ruby on Rails--you be the judge).
- Competition is pathetic (Cerner is the best.....McKesson? IDX/GE? pah).
- Buyers are America's dumbest corporations (hospitals) who like overpaying and overcharging....
- Epic doesn't even interoperate with Epic [and] there's no such thing as a standard install, My daughter's pediatrician in the Sutter System has Epic--NO Consumer access. Whereas at Palo Atlo Medical Foundation, which is Sutter AND has Epic, you can view your own record. Do you really think you cold move data from one to the other?

I guess the sad thing about American health IT is that this -- so far -- is the best we got (Matthew Holt)

....How much did Northern California Kaiser go over budget on their Epic implementation? $3 billion? Epic has the big dumb hospital/ foundation players by the short hairs and is milking it for all they can. And they have no intention of playing nice with other technologies or even their own kludgy systems. Of COURSE they argue that monopoly is the only valid solution... just like a privately-held corporation with a highly proprietary, closed-source solution should. (Paul Abramson)
Epic is the antithesis of the type of open IT architecture that will be needed to achieve accountable care. Epic is enterprise centric, not patient centric. (Vince Kuraitis)

OMG! All of this anger can't be healthy. However, don't expect much to change in the real EMR/EHR world as a result of this discussion. Link to Google+ if you want to read more in this thread.

One more thing. Has the NYT totally lost its way amidst the Epic adulatory mist? Here's what I think happened. Judith Faulkner NEVER gives interviews to the press. I suspect that Milt Freudenheim was advised by his editors to pitch only softballs to her in exchange for this exclusive audience. I know that the paper maintains that it never cuts such deals but why don't you read the article and judge for yourself. There must be some teeny, weeny problems somewhere in Verona that Milt could have uncovered.

A Reader Comments on Epic Interoperability and Care Everywhere

Bruce Friedman — 2012-01-18T09:41:10-05:00

In response to a recent note about Epic's Care Everywhere (see: Sharing Medical Records across Hospitals with Epic's Care Everywhere), a reader (Open Standards) posted a comment which I thought was instructive and worthy of promotion to the level of a note. I present it below in its entirety:

Per the Epic technical manual, Epic's Care Everywhere is [described in] the following [way]: 1. For Epic institutions, it is an XML file containing Epic proprietary extenstions to the continuity of care document. 2. For non-Epic institutions, it is an XML file containing the standard continuity of care document. Both of the above are variations of the same theme: the CCD document, an XML marked up document with the demographic, medication, medical history, and most recent encounter data abstracted from the EMR.

There is nothing particularly innovative about Epic's Care Everywhere. In fact, it is a Mearningful Use requirement for any EMR vendor to have CCD export capability. In this regard, all the 400+ MU certified EMRs in the U.S. have this functionality. A CCD document is vastly different than an HIE, which is an independent server that acts as a translation broker. The whole point of the CCD is to enable point-to-point transfer of a common standard machine readable summary of the patients data as a handoff document between any and all EMR.

In this regard, EpicCare specifically breaks the standard CCD form, and makes it incompatible with the rest of the 400+ EMRs in the USA by adding their proprietary extensions. This is consistent with Epic's proprietary, one-vendor-shop, non-interoperability stance. The statement that "any hospital can interoperate with Epic's Care Everywhere - just so long as they are an Epic institution" aptly summarizes this. Again, the proprietary extension to the CCD by Epic means that the 400+ certified EMR's in the USA won't interoperate with Epic's EMR, because these 400+ EMRs adhere to the government mandated open standard CCD XML form and Epic doesn't.

I would appreciate any further comments if this comment is erroneous or misleading in any way. On this basis, it would not be correct to describe Epic's Care Anywhere as a type of HIE. The name of the product is misleading but that nothing new in the software industry. It seems to be a proprietary version of CCD export capability -- a continuation of the Epic's "walled garden" software model.

Some Independent Physician Practices on the Brink of Financial Failure

Bruce Friedman — 2012-01-16T08:00:00-05:00

There are a number of factors contributing to the financial pressures being placed on community physicians. One of the most significant is that the federal government, the most important payer of medical costs, tends to favor inpatient and ambulatory care delivered by hospitals. A recent story provided the details (see: Doctors going broke). Below is an excerpt from it

Doctors in America are harboring an embarrassing secret: Many of them are going broke. This quiet reality, which is spreading nationwide, is claiming a wide range of casualties, including family physicians, cardiologists and oncologists. Industry watchers say the trend is worrisome. Half of all doctors in the nation operate a private practice...."A lot of independent practices are starting to see serious financial issues," said [ a consultant to physician practices]. Doctors list shrinking insurance reimbursements, changing regulations, rising business and drug costs among the factors preventing them from keeping their practices afloat. But some experts counter that doctors' lack of business acumen is also to blame....[A cardiologist] said recent steep 35% to 40% cuts in Medicare reimbursements for key cardiovascular services, such as stress tests and echocardiograms, have taken a substantial toll on revenue. "Our total revenue was down about 9% last year compared to 2010," he said. "These cuts have destabilized private cardiology practices," he said. "A third of our patients are on Medicare. So these Medicare cuts are by far the biggest factor. Private insurers follow Medicare rates. So those reimbursements are going down as well."....Also on his mind, the impending 27.4% Medicare pay cut for doctors. "If that goes through, it will put us under," he said.Changes in drug reimbursements have hurt [oncologists] badly. Until the mid-2000's, drugs sales were big profit generators for oncologists. In oncology, doctors were allowed to profit from drug sales. So doctors would buy expensive cancer drugs at bulk prices from drugmakers and then sell them at much higher prices to their patients. "I grew up in that system. I was spending $1.5 million a month on buying treatment drugs," [an oncologist] said. In 2005, Medicare revised the reimbursement guidelines for cancer drugs, which effectively made reimbursements for many expensive cancer drugs fall to less than the actual cost of the drugs.

There is no question that cutbacks in Medicare and Medicaid reimbursement are hurting many physicians in private practice. However, I also agree with the statement above that part of the problem is many doctor's "lack of business acumen." When times are flush and reimbursement is at a high level, faulty business practices can be glossed over. The same rule does not apply to current conditions. It's easy to manage a business on the way up and hard to manage one of the way down. Physicians spend many years in training but spend almost no time learning how to run a business.

I have posted a number of notes about the so-called oncology concession whereby oncologists purchase expensive cancer drugs at a wholesale price to treat their patients and then mark up the prices when they are administered (see: Academic Oncology and the "Chemotherapy Concession"; The Oncology Concession Under Attack by Health Insurance Companies). I have been told that it's easier to manage the expensive, limited-shelf-life chemothrapy inventory in academic oncology infusion centers with a large number of patients than in smaller private practices. Large cancer hospitals also benefit from the discounted volume purchases of such drugs.

The bottom line is that movement toward Big Medicine (Big Health Systems, Big Payers, and Big Pharma) persists unabated (see: Health Insurance Company to Purchase Troubled Pittsburgh Health System; Hospitals Use Their Medical Schools, Residencies for Later Physician Recruitment).

Connectivity and Hospital-Based EMRs; The EMR as an Operating System?

Bruce Friedman — 2012-01-13T08:00:00-05:00

John Lynn, who blogs over at EMR and EHR, had this to say recently about a company called Emdeon (see: Emdeon’s EHR Lite)

I’d been meaning to do a post about Emdeon‘s EHR lite ...since I first heard about it at MGMA. While I think that EHR Lite might be some good branding, I’m not sure you can really classify Emdeon’s EHR as lite. I’m sure they’re just trying to differentiate themselves from the 300+ EHR companies out there....I think I found the thing that most differentiates Emdeon from many other EMR companies. it’s their network. Here’s a summary they sent me of their network. Emdeon’s network encompasses:

340,000 providers
1,200 government and commercial payers
5,000 hospitals
81,000 dentists
60,000 pharmacies
600 vendor partners

....I strongly believe that healthcare will be a very heterogeneous environment. ...EHR software is still going to have to connect with hospitals, pharmacies, labs, payers, government entities etc. An EHR is going to be key to integrating with these other heterogeneous software as I do believe the EHR will be the “Operating System of Healthcare.” Today a silo’d version of an EHR is not an issue at all. However, the writing on the tea leaves that I read is that healthcare providers that have a well connected EHR are going to be at an advantage. We’ll see if Emdeon can use their current connections as an advantage in this way.

It's quite clear that hospitals need to be interconnected via multiple networks for the exchange of both clinical and financial information. Whether or not the leading EMR companies will move in this direction and function more as as "operating systems" is another story. Epic, for example, might appear to function as an HIE with its Care Everywhere module (see: Sharing Medical Records across Hospitals with Epic's Care Everywhere). However and given that this interconnectivity is provided only to Epic clients, the software would be better called Care with Epic Clients.

In my opinion, Epic has little interest in mobilizing healthcare information electronically across hospitals within a region that are not its clients. The company is all about domination of the higher end of the hospital market and modules like Care Everywhere have been developed to provide additional client functionality and not to serve as a HIE utility across all hospitals in a region (see: A Fresh Look at Epic from a Financial and Strategic Perspective). Epic's business model can be described as a "walled garden" whereas, I think, Cerner is envisioning the development of an interconnected community with its Winona project as one prime example (see: A Different Paradigm for Analyzing the Competition between Cerner and Epic; The Winona Project: Is This a RHIO Success Story?; Cerner's Winona Health Project Featured on the PBS News Hour).

I have posted notes before about the need for a national, agnostic lab network (see: Interpreting the Tea Leaves: Ten Hot Trends in Healthcare, Lab Medicine, and Pathology Informatics; Predicted Migration of "Some" LIS Functionality from Pathology to Central IT). For the labs, a national network is useful for the exchange of lab data but also as a means to access expertise and talent which may be lacking or insufficient locally. Community hospitals labs, and even academic departments, have always turned to regional and national reference labs to provide esoteric testing services that they can't supply. Any lab or hospital national network needs to be agnostic in the sense that it's open to a variety of companies and service providers. Such an approach stimulates competition on the basis of quality and price and is the antithesis of the walled-garden, vertically-integrated approach which is all about domination of the market by a single company (see: iPhones, Physicians, and the Dilemma of the "Walled Garden").

Geisinger Follows Cleveland Clinic; Won't Hire Smokers

Bruce Friedman — 2012-01-11T09:50:01-05:00

Cleveland Clinic established a ban on hiring smokers more than two years ago and similar policies are now spreading to other hospitals (see: Want a Job at the Cleveland Clinic?: Smokers Need Not Apply; Tobacco-Free Hiring Takes Hold; Both Smoking and Smokers Excluded; The Financial Stakes Escalate for Employees Who Smoke). Geisinger Health System has now introduced a similar policy (see: Hospital Quits Hiring Smokers, Introduces Nicotine Tests For Medical Workers). Below is an excerpt from the story

Smokers in the medical field now have another reason to quit as a Pennsylvania hospital has said it will no longer hire smokers and is introducing nicotine tests in order to enforce the rule....Those exposed to second hand smoke will be exempt from the test, which screens applicants for cigarettes, smokeless tobacco, snuff, nicotine patches, nicotine gum and cigars. For those who fail the test, the hospital says applicants can reapply after six months....According to CNN, Pennsylvania is among 19 states that allow employers to screen job applicants for signs of smoking. While there's certainly an incentive to keep employees healthy for work, the economic benefit of having non-smokers on the payroll is also notable. The U.S. Centers for Disease Control and Prevention (CDC) puts a $3,391 price tag on each employee who smokes: $1,760 in lost productivity and $1,623 in excess medical expenditures.

A few interesting points are brought out in this article relating to the exclusion of smokers as new hospital hires. A twist that was new to me in the article is that a prospective employee can claim an exemption from the hiring ban on the basis of second-hand smoke. I assume that the applicant would show a weakly positive lab test that could be explained by a smoker in his or her household or even in a car pool. I believe that the preferred test for a history of smoking continues to be cotinine (see: Saliva and Urine Tests for Smoking). Secondly and in the article, it seems that there needs to be enabling state laws in place to enable a hospital to pursue a smoking restriction; 19 states currently have such laws in place. I suspect that most of the states that have not yet fallen in line with such legislation will do so shortly. Smokers are becoming an endangered species.

Lastly, there is data presented at the end of the excerpt above that place a cost to employers for employees who smoke, providing convincing financial evidence for the soundness of a "no smokers, no smoking" policy for hospitals. It seems to me that there are three health system that usually take the lead regarding innovative clinical and organizational policies: Cleveland Clinic, Geisinger, and Kaiser. You can now expect many other hospitals, initially in the 19 states, to launch similar policies.