Lab Soft News

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

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 [email protected]
• $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

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

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

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.

More Discussion on the Recent NYT Article about Epic

Mr. HIStalk has responded to a reader's comment about Epic relating to the recent NYT article covering the company (see: News 1/20/12). Here's a link to my recent note on this same article (see: More on Epic's (Non)-Interoperability and the Recent NYT Puff Piece) and a link to the original NYT article (see: Digitizing Health Records, Before It Was Cool). Below is the Q and A exchange and response in HIStalk:

Reader Comment: From Otoscope: “Re: Epic. I hear that Epic is competing for a deal in NYC. I wonder if the puff piece in the Times about how cool their campus is and Judy Faulkner giving them a rare interview isn’t an Epic marketing push to win over some decision-makers struggling to find a reason to pay Epic’s exorbitant asking price? Maybe there’s a pattern of newspaper exposure where Epic had other high-profile deals on the table.”

Mr. HIStalk response: The article also claims that Epic steals the best programmers who would otherwise be working for Google or Facebook, which seems a bit of a stretch given Epic’s reputation for hiring new grads with no experience. I doubt many world-class programmers are torn between working with cutting edge technology for Facebook in the Silicon Valley vs. moving to chilly Wisconsin to write MUMPS just because Epic’s campus is cool (not that there’s anything wrong with that, especially if they’re doing it for the satisfaction of helping patients.) The article was a bit fawning, but it was a business feature, not a hard-hitting expose’.

I was not looking for a hard-hitting expose from the NYT on Epic. However, I did expect, perhaps, a little more balance when a prestigious newspaper covers a company that many would say is the most talked about EMR company in the country. After all, the federal government has established programs to feed billions of dollars to hospitals that digitize their records and a good portion of it is going to Epic. Let me quote from this same article on the influence of the company:

Epic has been adding other large customers, for a total of 260, including 35 new contracts last year. All told, it says, its systems will cover 127 million patients with active electronic health records by July 2013. It now has 5,100 employees; to handle all that growth, it plans to hire 1,000 more people this year. Its customers include many hospitals that are connected to medical schools, as well as large physician groups. The Epic software system is a “de facto standard among the more complex academic health centers and multispecialty medical groups,” says Dr. John D. Halamka, chief information officer of Beth Israel Deaconess Medical Center in Boston and a professor at the Harvard Medical School.

If you were a journalist writing this article for the NYT and the company's software was referred to as the "de facto standard among the more complex academic health centers", would it not occur to you to quote some experts in the field with a less rosy view about the Epic business model, interoperability of Epic systems with other EMRs, and some of the controversy enveloping CEO Judith Faulkner (see: More on Epic's (Non)-Interoperability and the Recent NYT Puff Piece; A Reader Comments on Epic Interoperability and Care Everywhere; Judith Faulkner of Epic Becomes Target for Tea Baggers and the Religious Right).

The Next Step in the Development of Personalized E-Newspapers

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?

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

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

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

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).