Lab Soft News

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

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

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.

Risk Factors Relating to the Rising Trend of Hepatocellular Cancer in the U.S.

Hepatocellular cancer (HCC) is a common neoplasm in Asian countries because of the high incidence of hepatitis infection. Here are the three most common risk factors for (HCC):  (1) alcoholism; (2) hepatitis B; (3) hepatitis C that causes 25% of causes globally (see: Hepatocellular carcinoma). Although HCC has been relatively rare in the U.S., the incidence is now rising quickly (see: Mayo Clinic Studies Identify Risk Factors In Rising Trend Of Liver Cancer). Here's more details from a recent article:

Doctors have known for years that the incidence of deadly liver cancer is on the rise, but what is causing that trend has remained a mystery. Two recent studies...offer a clearer picture of the rise of hepatocellular carcinoma (HCC), or liver cancer, which has tripled in the U.S. in the last three decades and has a 10 to 12 percent five-year survival rate when detected in later stages....[One] study found the overall incidence of HCC in the population (6.9 per 100,000) is higher than has been estimated for the nation based on data from the National Cancer Institute ....The study also found that HCC, which two decades ago tended to be caused by liver-scarring diseases such as cirrhosis from alcohol consumption, is now occurring as a consequence of hepatitis C infection. "The liver scarring from hepatitis C can take 20 to 30 years to develop into cancer," [one study author said]. "We're now seeing cancer patients in their 50s and 60s who contracted hepatitis C 30 years ago and didn't even know they were infected. " Eleven percent of cases were linked to obesity, in particular fatty liver disease. "It's a small percentage of cases overall," [the study author said]. "But with the nationwide obesity epidemic, we believe the rates of liver cancer may dramatically increase in the foreseeable future." Another study looked exclusively at the Somali population, which is growing in the U.S., particularly in Minnesota, where as many as 50,000 Somalis have settled in the last two decades. The East African country is known to have a high prevalence of hepatitis B, a risk factor for HCC. Researchers investigating records in the Mayo Clinic Life Sciences System confirmed that hepatitis B remains a risk factor, but they were surprised to find that a significant percentage of liver cancer cases in the population are attributable to hepatitis C, which had not been known to be significantly prevalent.

What I took away from this article is that the incidence of HCC is rising precipitously due to chronic hepatitis B and C infections in our native-born population, immigrants coming to this country carrying the two viruses, alcoholism, and obesity. It's a "perfect storm." Here's some more information about the relationship between obesity, diabetes, and HCC (see: Obesity and hepatocellular carcinoma):

Both obesity and diabetes are frequently associated with nonalcoholic fatty liver disease, and case reports have shown progression of nonalcoholic fatty liver disease to cirrhosis and hepatocellular carcinoma. Although no study has clearly tied all of these variables together, it is likely that the association of hepatocellular carcinoma with obesity represents the progression of underlying nonalcoholic fatty liver disease to cirrhosis. The mechanism most likely involves replicative senescence of steatotic mature hepatocytes and compensatory hyperplasia of progenitor (oval) cells as a reaction to chronic injury due to ongoing nonalcoholic steatohepatitis and resultant hepatic fibrosis.

Also see: Bristol bags hot hep C drug developer Inhibitex for $2.5B.

A New Face of Philanthropy: Do-It-Yourself Drug Development

It's said that the philanthropic goals of younger individuals often differ from that of older generations in that they favor a more hands-on approach to their giving. They want to exercise more control over their charitable contributions. This approach was apparent in a recent article about "do-it-yourself drug development" (see: Do It Yourself Drug Development — With Some Help). Below is an excerpt from it:

The effort by two families to buy and develop a drug that holds promise in treating Duchenne muscular dystrophy...is the result of an innovative new model set up to support the burgeoning phenomenon of do-it-yourself drug development. Before the Seckler and Wicka families bought halofuginone, a drug that showed promise in experiments done with Duchenne mice, they set up Dart Therapeutics. Dart is funded by foundations set up by the two families, and run by Eugene Williams, a drug industry veteran with 25 years’ experience, including seven years at Genzyme. Mutual acquaintances led the Secklers and Wickas to Williams in 2010, when the families were discussing how to advance drug development in Duchenne muscular dystrophy. The disease is rare, with only around 20,000 new cases a year, and both families were increasingly frustrated that despite raising many millions to help fund research and experimental drug development programs, promising compounds frequently went nowhere.  They wondered if, with expert advice, patients and advocates in some cases might be able to develop drugs themselves. That idea led to the formation of Dart in June, 2010. Williams, who is the chairman, put together a “virtual company” ...comprised of former senior executives and consultants expert in developing drugs and getting them through the FDA approval process. The idea, says Tracy Seckler, whose son Charley has Duchenne ...was to create a vehicle to identify potential compounds, make deals, and develop the drugs....In cases where Dart decides it’s worth it to buy the drug — which is what happened when it took a look at halofuginone — a separate company will be formed. (In the case of halofuginone, the company is called Halo Therapeutics.)

To summarize this complicated narrative, the Seckler and Wicha families have a special interest in Duchenne muscular dystrophy; a son of the Seckler family has the disease. The families established a pharmaceutical company, Dart Therapeutics, that is funded by their family foundations. They then hired a veteran pharmaceutical executive to run Dart with a small staff, The company functions as a virtual organization that hires consultants to assist it in discovering and bringing suitable drugs to market. They then purchased a drug, halofuginone, that shows promise in treating Duchenne mice that will be managed by yet another company, Halo Therapeutics.

Fascinating story. Benefactors from a previous generation with an interest in Duchenne might have channeled their contributions through a charity with a focus on neurologic diseases. But in such a setting, progress toward the development of a new drug would have been slow and tangible results perhaps rare. You might say that drug development is a slow process best left to the professionals. However and in the case of Dart, the families engaged the services of veteran pharma executive to help them pursue their goals.

Here's some more information about orphan drug development from the Wikipedia (see: Orphan drug):

Since the market for any drug with such a limited application scope would, by definition, be small and thus largely unprofitable, government intervention is often required to motivate a manufacturer to address the need for an orphan drug. Critics of free market enterprise often cite this as a failure of free market economic systems. The intervention by government on behalf of orphan drug development can take a variety of forms:

• Tax incentives.
• Enhanced patent protection and marketing rights
• Clinical research financial subsidization.
• Creating a government-run enterprise to engage in research and development

In the case of Dart, federal initiatives to encourage orphan drug development comes in the form of favorable tax treatment for family foundations. Obviously, the creativity of the families behind these foundations played a major role. This is a great model for a more active form of philanthropy in the future.

Sharing Medical Records across Hospitals with Epic's Care Everywhere

Health information exchanges (HIEs) have had a mixed record of success. This type of organization can be defined in the following way, courtesy of Wikepedia:

Health information exchange (HIE) is defined as the mobilization of healthcare information electronically across organizations within a region, community or hospital system. HIE provides the capability to electronically move clinical information among disparate health care information systems while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to and retrieval of clinical data to provide safer, more timely, efficient, effective, equitable, patient-centered care.

The key to success of HIEs is sustainability, both financial and organizational. Here's a key quote relating to HIE failure from the HIELIX web site:

Sustainability is the issue that most frequently causes HIE failure. With so many stakeholder groups, finding financial success through the implementation of new software, new computer systems, new training and new business models can seem impossible. Success comes from building consensus between these stakeholders and creating a plan that realizes significant cost-savings by improving operational efficiencies and building scalable solutions.

I was unaware until I read Mr. HIStalk's recent note that Epic was in the HIE business (see: Monday Morning Update 1/2/12). I now know otherwise. Here it is in its entirety:

Cleveland, OH health systems Cleveland Clinic and MetroHealth are sharing electronic patient records and Kaiser Permanente will join them shortly. They’re using Epic’s Care Everywhere rather than an HIE, meaning they can access the records of patients who have opted in from 300 hospitals and 4,000 clinics.

Here's a description of Care Everywhere from the Epic web site (see: Epic Interoperability):

Care Everywhere provides a framework for interoperability, so that wherever the patient goes – between healthcare systems in the same town or across state and national borders – the clinicians providing care can have the information they need. Information can come from another Epic system, a non-Epic EMR that complies with industry standards, or directly from the patient. When an Epic system is on both sides of the exchange, a richer data set is exchanged and additional connectivity options, such as cross-organization referral management, are available. Regardless of the information source, Care Everywhere connects it to your EpicCare EMR, giving clinicians a more complete clinical record

Care Everywhere strikes me as a logical and tactically admirable addition to the broad Epic software suite, taking advantage of the company's now dominant presence in the large hospitals (see: Does Epic Exercise a Near-Monoply for EMRs in Larger U.S. Hospitals?; The Feasibility of Using the Epic EMR as a "Platform" to Extend Its Functionality). Moreover, it's also an effective response to critics of the company who say that it's not interested in interoperability (see: Judith Faulkner, EMR Interoperability, and Washington IT Politics). The charge seems to be false, at least when its own client hospitals are involved.

Should Hospitals Begin to Charge a Fee for Autopsies?

I have posted two notes pertaining to the intrinsic value of autopsies and whether virtopsies should be substituted for the classic autopsy (see: A Clinician Laments the Decline of the Autopsy; More on the Value of the Classic Autopsy Based on a Reader's Comment). Here's a comment from Dr. Karl Robstad in response to the second of these notes:

As an aside, perhaps charging for autopsies might reduce the number of "unnecessary" autopsies. It's one thing to perform them in cases of sudden death, unclear cause of death or even in cases where the diagnosis is known but is rare or has high educational value; but, in my opinion, it is completely another to do restriction-less dissections of 90+ year-olds with a laundry lists of acronymous chronic diseases and obvious COD's [cause of death]. Simply, if you tell someone something is free, they are likely to want it, regardless of it's actual value. If case selection is more carefully curated, free or not free, I bet [virtopsies] would be embraced.

I believe that the idea of charging a fee for an autopsy has merit and is worth discussing. For now, I will avoid the contentious topic of who would pay the fee, assuming that the insurance companies and Medicare would pick it up. I had also previously understood that the cost of autopsies was theoretically "baked" into DRGs when they were launched many years ago. Therefore, Medicare officials might object to a new charge for autopsies, saying that the government is already theoretically paying for them. However and also putting this argument aside, I think that the most telling case against a charge for autopsies is that there have been fewer and fewer clinicians opting for the current free procedure. How do you justify charging for an autopsy when few clinicians elect to order one for free?

Karl's comment has given me another idea, however. How about persuading radiology departments to offer post-mortem total-body, high-intensity CT scans -- in essence, the first half of a virtopsy. The acceptance rate among family members would presumably be high because it would differ little from ante-mortem imaging procedures. We would then be able to obtain standardized, retrievable imaging, plus interpretation, of post-mortem pathology for those who accept the offer. A well established fee schedule for CT scans would be available as a benchmark. If such a procedure were offered by radiology, I am sure that the hospital pathology departments would quickly see the merit of the total virtopsy (imaging plus selected gross and microscopic tissue examination). We would then quickly have an operational model for close collaboration between pathology and radiology in the performance of all subsequent virtopies.

More on the Value of the Classic Autopsy Based on a Reader's Comment

Pathologist Mark Pool commented on my recent note regarding the value of the classic autopy and the adoption of the virtopsy as an improved form of the procedure (see: A Clinician Laments the Decline of the Autopsy). His comment was so useful that I decided to promote it to the level of a note. It is presented below in its entirety:

Thanks...for another provocative post on the autopsy. I guess I'll take the bait! The subject of this post reminds me of a saying I used to hear as a boy: "Two can live as cheap as one, if one don't eat." We talk the talk of wanting to improve quality, but the fact of the matter is that the autopsy (as it is currently) is a time- and energy-consuming endeavor whose value to medicine (as measured by its compensation) it exactly: zero.

Encouraging more autopsies without reforming how our time is reimbursed is reckless and feckless--no matter what it contributes to education and/or quality. While I'm doing the autopsy for Dr. Gompf, she is likely seeing patients in clinic--meanwhile after I drag myself back to my office from the morgue, I still have trays of slides left that I have to sign out. Since I stand astride community and academic practices, I can also attest to the fact that autopsies are equally discouraged and demeaned even in teaching centers. If I hear any hue-and-cry for the autopsy (as things stand now), I'm running for the hills!

With that being said, I agree that the virtopsy would be a brilliant alternative that actually would address several different problems and deficiencies (which can be deduced from your last enumerated points). This could be a ax-handle for our College [i.e., College of American Pathology; CAP] to use if we seriously want to promote evidence-based medicine and improved patient care. As things are now, we get what we pay for.

As far as I can tell, there is no mainstream movement to abolish the autopsy or even reform it. In the face of it being demeaned by pathologists and clinicians alike, I suspect that it will continue to undergo atrophy in community hospitals and persist mainly in academic centers for training pathologists. I don't think that increasing reimbursement for the autopsy would help much if clinicians have gotten out of the habit of ordering the procedure and depending on it as part of their continuing understanding of pathophysiology and treatment.

Mark appropriately links the value of a virtopsy with evidenced-based medicine (EBM). For me, one of the most useful aspects of the virtopsy would be the linkage of the CT images obtained during the procedure with the coded post-mortem diagnoses of the pathologist as well as the post-mortem H&E tissue sections. To the best of my knowledge, our current autopsy reports make little or no contribution to EBM studies. Although I agree that the virtopsy could serve as an "ax-handle" issue for the CAP, the organization's lackluster support for an even more critical issue, digital pathology, suggests that we won't receive much help from this quarter regarding autopsy reform (see: Did the CAP do enough for digital pathology and discussions with the FDA?).

FDA Warned French Company Founder about Breast Implant Safety Issues

You may be aware of recent news about a recall of French silicone breast implants manufactured by a company named Poly Implant Prothese (PIP) (see: France ponders removing recalled breast implants). It turns out that the FDA issued a warning letter to the founder of the company in 2000 about irregularities in the manufacture of PIP's saline implants (see: FDA warned French plant on implant safety in 2000). Note that the plant inspected by the FDA was also used to manufacture the silicone implants for PIP. Here is an excerpt from the article:

As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost 10 years before the company came under scrutiny from European regulators. The U.S. Food and Drug Administration sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP)...in May 2000. Shortly afterwards, the FDA sent the company's founder, Jean-Claude Mas, a warning letter [via Fedex on June 22, 2000] saying the implants were "adulterated" and citing at least 11 deviations from good manufacturing practices. The problems had to do with PIP's saline implants, a different line from the silicone implants that French authorities ordered off the market in 2010 for using industrial-grade silicone instead of medical-grade silicone, leading to the French firm's bankruptcy. Still, the plant inspected by the FDA was used to manufacture the silicone implants for PIP. The French government last week recommended that women in France who have PIP's silicone gel-filled implants get them removed by their surgeons after the implants appeared to have an unusually high rupture rate. Other countries, including Britain and Brazil, said women should visit their surgeons for checks. A critical question is why the FDA's warning didn't trigger greater scrutiny of PIP's activities by regulators in France and elsewhere. 

I think that I know the answer to the question that was posed at the end of this article: why didn't the FDA's warning trigger greater scrutiny of PIP's activities by regulators in France and elsewhere? The FDA sent its letter to the company founder, Jean-Claud Mas, and not to French governmental authorities. Perhaps Monsieur Mas was not prepared to confess about his poor manufacturing processes at that time. Here's a quote by a Mas spokesperson from another article on this same subject (see: Breast implant boss admits using 'unapproved' silicone gel):

Jean-Claude Mas, speaking through his lawyer Yves Haddad, told The Times that his now-bankrupt company Poly Implant Prothese (PIP) made implants using high-quality gel for rich clients . But "simple" versions sold at discount prices used industrial-grade silicone that had not received approval by health authorities. Mr Mas admitted that a product made by PIP "did not formally receive approval, and in this regard there was a violation of regulations". "Why did this company use this kind of product? Because it was a corporation with economic objectives and because of corporate management that tried to get the best cost," he said. "There was a basic product and there was a high-end product, for people in the 16th [arrondissement] for example," he added, referring to the upmarket Paris district. According to PIP, the "house gel" version was "just as effective but five times cheaper" than the more expensive type.

This strikes me as a relatively odd rebuttal to the crime of using industrial grade silicone for breast implants. It was cheaper to do so and the corporate goal was to reduce the cost of the implant and, in so doing, make them cheaper and thus more accessible for the common folk.

NYT Highlights the "Virtopsy" Used for All Military Autopsies