Lab Soft News

PET Scans of Brain for Tau Protein an Early Predictor of Memory Loss

For the past few years, one of the most important research areas in radiology has been the search for reliable imaging techniques to diagnose early Alzheimer's disease. This has involved attempts to identify deposits of both beta amyloid and tau protein (see: Diagnosing Alzheimer's Disease with Imaging and Biomarkers; Brain Plaque Diagnostic Imaging Procedure Approved by FDA; Alzheimer's Amyloid Tangle Theory Will Be Tested with Merck Drug Trial). A recent article provides a progress report on this research relating to tau protein (see: Tau Imaging Strong Predictor of Memory Loss):

Tau protein in key brain areas of cognitively normal older individuals is strongly correlated to memory loss over time, preliminary research shows. [A researcher recently] found that F18 T807...), a novel positron emission tomography (PET) tau tracer that binds to tau in both the entorhinal cortex and the temporal neocortex, is related to episodic memory decline in normal older people."Our findings indicate the spread of tau, under the influence of, or in the presence of [beta amyloid], to widespread cortical regions may be the sign, the smoking gun, that cognitive impairment is imminent or already under way," [he said]....In addition to beta amyloid (Aβ) plaques, tau neurofibrillary tangles are hallmark pathologies of AD that are laid down many years before symptoms of cognitive decline present. However, until now, detection of tau in the brain has only been possible at autopsy. A normal component of nerve cells, tau helps stabilize the internal neural transport system and supports architecture of neural cells. However, in dementia, the protein transforms and begins to accumulate in abnormal forms. Previous research suggests that levels of tau in the brain may be more closely associated with cognitive decline in AD than Aβ... Going into the study, the investigators hypothesized that tau was going to be "closer to the action" than Aβ and indicate incident impairment and that "when the tau compound binds to the sites in the brain, it was going to show us that these are the people that are about to have trouble or who have already started to have cognitive impairment." The investigators' hypothesis bore out, and they found that there was a "highly significant" relationship between a worsening of memory performance and higher levels of T807 binding in the brain. Identifying early buildup of these proteins in the brain, before cognitive decline occurs, may offer a road to early detection and diagnosis of AD and help identify candidates for prevention studies, investigators note.

Being able to diagnose Alzheimer's disease (AD) in its early stages is important for two reasons. First, it's an important step for differentiating it from other forms of dementia. "The most common form of dementia is Alzheimer's disease (75%). Other forms include Lewy body dementia, vascular dementia, frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration, normal pressure hydrocephalus and Creutzfeldt–Jakob disease (see: Dementia)." Secondly, a definitive diagnostic method is critical for conducting clinical trials of drugs that can cure or prevent the development of the disease. Here is a description of how how AD is currently diagnosed (see: Alzheimer Disease Imaging):

Current diagnosis of Alzheimer disease ... is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance.

AstraZeneca Partners with Roche on Development of a Companion Diagnostic

The topic of companion diagnostics has been of continuing interest for me. I have posted a number of notes about this type of lab test (see, for example: More Details About Roche's Companion Diagnostics Strategy; A Closer Look at Companion Diagnostics Strategies; Consideration of a Broader Definition for "Companion Diagnostics"; Some Interesting Insights into Companion Diagnostics; Companion Diagnostics Gains Wider Acceptance in FDA Despite Challenges). Now comes news of a new collaboration between AstraZeneca and Roche on a diagnostic test to be used as a companion for AZ9291, an investigational compound (see: AstraZeneca, Roche Collaborate on Companion Diagnostic Test). Below is an excerpt from the article:

AstraZeneca announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC). The companion diagnostic test is designed to identify epidermal growth factor receptor (EGFR) mutations in both tumor tissue and plasma derived from patients with NSCLC, and to optimize the clinical development of AZD9291 for patients who are resistant to first-generation EGFR tyrosine kinase inhibitors (TKI). Currently, patients who have been treated with EGFR-TKIs in whom the disease has progressed have to undergo a repeat biopsy to assess whether they have a specific mutation, T790M. Diagnostic tests based on circulating DNA (ctDNA) in plasma samples provide an alternative method of identifying the T790M mutation....“Currently, late-stage lung cancer patients have to undergo surgery to collect tissue from a tumor so it can be sent for molecular testing,” said Paul Brown, head of Roche Molecular Diagnostics (RMD). “In some cases, collecting enough tissue for testing is not possible. This collaboration will enable molecular testing through plasma specimens and provide the information needed to inform treatment decisions without the complications of surgery, consequently increasing the level of care clinicians can give to the patient.” NSCLC represents approximately 80 to 85% of all lung cancers. Unfortunately, at the time of diagnosis approximately 70% of NSCLC patients have developed advanced or metastatic disease not amenable to surgical resection. 

To summarize, AstraZeneca is working with Roche on a companion diagnostic to identify epidermal growth factor receptor (EGFR) mutations in both tumor DNA as well as in DNA circulating in plasma. The source of the latter is circulating tumor cells (ctDNA). Analysis of plasma ctDNA to detect tumor recurrence avoids the need to biopsy tumor tissue and thus the complications of additional surgery. This article illustrates the dual use of companion diagnostics. First of all, the test can be used to determine whether a patient is a candidate for a particular drug therapy -- compound AZ9291 in this case. The fact that the drug does not yet have a proprietary name is evidence of the very early stage at which the companion diagnostic is being developed. Secondly, the diagnostic test can also be used to identify circulating tumor DNA in the plasma.

NSCLC, a confusing term, is the most common type of lung cancer. Unfortunately and as noted above, some 70% of NSCLC patients have advanced disease at the time of diagnosis that is not amenable to surgical resection. The term NSCLC encompasses the following three histologic types of neoplasm (see: Lung cancer - non-small cell): 

• Adenocarcinomas that are often found in an outer area of the lung.
• Squamous cell carcinomas that is usually found in the center of the lung next to a bronchus.
• Large cell carcinomas that can occur in any part of the lung. They tend to grow and spread faster than the other two types.

It's Time for More Formal Strategic Planning Efforts in Pathology

I believe that there is inadequate strategic planning taking place in pathology and by pathologists. It's true that many of the individual pathology societies support some strategic planning activities but there are few published reports articles addressing the challenges facing our specialty. Here's what I consider the four of the most important challenges facing the field consideration from a strategic perspective: (1) cancer oncology; (2) digital pathology; (3) the future of the LIS; (4) increased lab complexity with reduced lab budgets. 

By way of contrast, radiologists has been addressing strategic planning in their field head-on for many years. For example, the International Society of Strategic Studies in Radiology (ISSSR) held its ninth biennial meeting in August 2011. Here is the citation for the published proceedings of that meeting: Eur Radiol (2012) 22:2283-2294. This article is a revealing compendium about what the future holds for radiology. A number of topics are addressed in the proceedings including molecular imaging, diagnostic algorithms, information technology in radiology, integrated diagnostics, and health information exchanges. Here's a passage from the article describing population imaging:

Population imaging employs computational radiology techniques such as unstructured and structured data mining, image segmentation, and statistical modeling to map and summarise imaging features from large image databases and thus extract meaningful imaging biomarkers. The biomarkers may be anatomic structures, disease manifestations, tumour characteristics, or haemodynamic abnormalities. The summation of one or more imaging features, or biomarkers, from a global data set can be considered a phenotypic “population image” representing a particular disease or health state. In clinical care or clinical trials, population images may be used as a reference to classify individuals or patient groups into diagnostic categories. Radiologists can play a key leadership role in providing the needed intuition to productively integrate the computational information from population images with personal medical information....These imaging biomarkers may facilitate prediction of future disease onset, the development and implementation of preventive measures, and even the development of pre-clinical diagnostics....Furthermore, because of the statistical power provided by large sample sizes, population studies using global databases could potentially replace individual prospective studies as a means of validating new biomarkers, saving both time and money.

Here's a more succinct definition of population imaging (Population Imaging):

The ultimate aim of the European Population Imaging Infrastructure is to help the development and implementation of strategies to prevent or effectively treat disease. It supports imaging in large, prospective epidemiological studies on the population level. Image specific markers of pre-symptomatic diseases can be used to investigate causes of pathological alterations and for the early identification of people at risk.

I certainly applaud the strategic planning efforts of our colleagues in radiology and this focus on population imaging effort has tremendous merit. However, the apparent absence of clinical and anatomic pathology data  in this project is a significant problem.

Big Pharma Pursues the Development of "Electroceuticals" with Google

One of the major goals of Big Pharma is to enlarge its customer base, which is to say, sell more product. One way to accomplish this is through the medicalization of "conditions" that previously have not been viewed as diseases. One example of such a condition is obesity. This medicalization process has also been referred to as "disease mongering" (see: Disease Mongering (i.e., Medicalization) by Pharmaceutical Companies; Medical Device Mongering, a Variant of Disease Mongering). The reason that Big Pharma spends huge amount of money each year on direct-to-consumer (DTC) advertisements on TV is to circumvent physicians by creating demand for prescription drugs among consumers (see: Effectiveness of "Direct-to-Consumer" Drug Advertisements). Although consumers can't write prescriptions, they can certainly request a particular drug from their physician.

Given all of this, it should not be surprising that the pharmaceutical industry is  teaming up with Silicon Valley companies to develop wearable IT devices to monitor health. The details of a recent Google/Novartis deal were discussed in a recent article in the Financial Times (see: Big pharma teams up with big data). Below is an excerpt from it:

Big pharma and Silicon Valley have been circling one another for some time, looking for ways in which they might harness the power of data technology to medical ends. Now a fusion of West Coast entrepreneurship and lab-coated medical expertise has spawned its first big publicly announced transaction. Google has struck a deal with Novartis to develop a “smart” contact lens designed to help diabetics track their blood sugar levels. The lens works by analysing the level of glucose in a wearer’s tear fluid and communicating the data to a mobile device. It replaces the need for diabetics to test their own blood sugar several times a day....But this is only one of the reasons to applaud the marriage of pharma and big data, and the emergence of such “wearable” medical devices. The increasing incidence of chronic diseases and an ageing population has created the need for real-time health monitoring. At a time of stretched healthcare budgets, having a device that tracks the state of the wearer’s health can help to give physicians better early intelligence of problems, reducing the need for costly interventions and long hospital stays later on. Monitoring is, moreover, only part of the story. Wearable technology may also have a role to play in treating conditions. For instance, Novartis is also looking at using Google’s technology to produce an “autofocusing lens”....Another area of investigation is into so-called “electroceuticals”. These are implants that use electronic impulses to affect and modify the functions of the body. 

I have no problem with wearable devices for monitoring health status. I think that this is both inevitable and useful for increasing health awareness among the general population if not to improve health. I am also enthusiastic about the notion of having healthcare consumers take more ownership of their own health status. Early autodiagnosis and ongoing health monitoring is certainly one way to reduce the cost of healthcare by avoiding the expense of nagging chronic diseases. Why then would I be concerned about pharmaceutical companies getting involved in the development of such devices? My greatest fear is that the companies will "fudge" these devices such that the diagnosis of various diseases and the need for treatment will be overstated. This will be an extension of the medicalization discussed in the first paragraph. One example of such chicanery was a rigged depression survey that Eli Lilly posted on the web. The company manufactures the anti-depressant Cymbalta. Regardless of how one answered the survey, the conclusion was that the subject may be depressed (see: Rigged Depression Survey on the Web Steers Readers to Lilly's Cymbalta). 

The Changing Face and Diagnostic Challenge of Diabetes

A recent article addressed both the diagnostic challenge and the changing presentation of diabetes mellitus.  It included a description of the development of a new microchip for the inexpensive analysis of the autoantibodies that are pathognomonic of type-1 disease (see: Type 1 diabetes can be diagnosed with new microchip). Below is an excerpt from it:

An inexpensive, portable, microchip-based test for diagnosing type-1 diabetes could improve patient care worldwide and help researchers better understand the disease, according to the device’s inventors at the Stanford University School of Medicine....The handheld microchips distinguish between the two main forms of diabetes mellitus, which are both characterized by high blood-sugar levels but have different causes and treatments. Until now, making the distinction has required a slow, expensive test available only in sophisticated health-care settings....Better testing is needed because recent changes in who gets each form of the disease have made it risky to categorize patients based on their age, ethnicity or weight, as was common in the past, and also because of growing evidence that early, aggressive treatment of type-1 diabetes improves patients’ long-term prognoses. Decades ago, type-1 diabetes was diagnosed almost exclusively in children, and type-2 diabetes almost always in middle-aged, overweight adults....Now, because of the childhood obesity epidemic, about a quarter of newly diagnosed children have type-2 diabetes. And, for unclear reasons, a growing number of newly diagnosed adults have type-1. Type-1 diabetes is an autoimmune disease caused by an inappropriate immune-system attack on healthy tissue....The disease begins when a person’s own antibodies attack the insulin-producing cells in the pancreas. The auto-antibodies are present in people with type-1 but not those with type-2, which is how tests distinguish between them....The old, slow test detected the auto-antibodies using radioactive materials, took several days, could only be performed by highly-trained lab staff and cost several hundred dollars per patient. In contrast, the microchip uses no radioactivity, produces results in minutes, and requires minimal training to use. Each chip, expected to cost about $20 to produce, can be used for upward of 15 tests. 

It used to be the case that type-1 diabetes with an autoimmune etiology was diagnosed in childhood and type-2 disease was diagnosed in older adults. This latter disease was often referred to as adult-onset diabetes. The age of the patient thus took the physician most of the way to the diagnosis. Now and due to the epidemic of childhood obesity, children are developing type-2 disease and some adults, for unknown reasons, are developing autoimmune disease. Type-1 and type-2 diabetes can be differentiated using an analysis for pancreatic islet cell autoantibodies but the test is slow and expensive (see: Autoantibodies in Diabetes). Researchers at Stanford are now developing a micro-chip based test for autoantibodies that is reportedly both fast and inexpensive.

Here are some additional comments about the microchip-based test and the diagnosis of diabetes from a Stanford web site (see: Researchers invent nanotech microchip to diagnose type-1 diabetes):

The microchip relies on a fluorescence-based method for detecting the antibodies. The team’s innovation is that the glass plates forming the base of each microchip are coated with an array of nanoparticle-sized islands of gold, which intensify the fluorescent signal, enabling reliable antibody detection....In addition to new diabetics, people who are at risk of developing type-1 diabetes, such patients’ close relatives, also may benefit from the test because it will allow doctors to quickly and cheaply track their auto-antibody levels before they show symptoms. Because it is so inexpensive, the test may also allow the first broad screening for diabetes auto-antibodies in the population at large. “The auto-antibodies truly are a crystal ball,” [the inventor of the chip] said. “Even if you don’t have diabetes yet, if you have one auto-antibody linked to diabetes in your blood, you are at significant risk; with multiple auto-antibodies, it’s more than 90 percent risk.”

Free-Standing Emergency Rooms; A New Type of Healthcare Facility

Free-standing emergency rooms seem to be emerging as a new category of healthcare facilities, at least in New York City. This according to a recent article about this trend (see: E.R., Not a Hospital, Is Set to Open at St. Vincent’s Site). Below is an excerpt from the article:

The shiplike building on Seventh Avenue that used to house part of St. Vincent's Hospital is reopening in the coming days as a stand-alone emergency room and medical care center....The new E.R. [called HealthPlex], however, is part of a trend that has as much to do with a hospital’s bottom line as it does with providing acute care. Free-standing emergency rooms...have sprouted up around the country in recent years, driven by competition to capture lucrative markets, like the neighborhoods around Greenwich Village. Operators of free-standing emergency rooms....say they fill an important void in areas without full hospitals. They can bring in significant revenue, since they are allowed to charge the same high fees that hospitals charge while having lower overhead. And, since half of admissions come from the emergency room, free-standing E.R.s can funnel patient business to their parent hospitals....The first free-standing emergency room in New York State opened in the Bronx last year, and three more have opened since....Operators of free-standing emergency rooms like the HealthPlex say they fill an important void in areas without full hospitals. But the HealthPlex also appears designed to be an advertisement for the larger North Shore system, and to attract the kind of wealthy West Village residents who avoided St. Vincent’s....Ambulances will not bring patients suffering major trauma, head or spinal cord injuries, heart attacks, acute strokes, psychiatric disturbance or pregnancy-related complications, among other maladies, to the HealthPlex. But...[a hospital representative] said that if someone with any of these conditions walked through the door, the doctors at the HealthPlex would do everything that would be done in a hospital-based emergency room to stabilize the person and then transfer the patient by ambulance to the nearest appropriate hospital....Dr. Howard Mell, a spokesman for the American College of Emergency Physicians, said that in about 1 percent of cases, minutes could make the difference between a good outcome and a bad one, and the extra time for the transfer might be detrimental. But, he said, there were also cases in which getting to an emergency room sooner — because a free-standing emergency room had opened in an area that lacked a hospital — could be lifesaving.

So, like many initiatives in healthcare, the quest for increased revenue seems to be one of the main drivers in the development of free-standing ERs. The hospital systems that own them are allowed to charge the same rates for services as they do in the case of an embedded hospital ER. However, free-standing ERs don't incur the cost of expensive inpatient units such as the critical care units. They thus benefit from higher profit higher margins while, at the same time, providing the opportunity for inpatient admissions to nearby local hospitals within their system. Residents of the neighborhood benefit from rapid attention if they have a acute medical issues but suffer from the disadvantage of needing to then be transported to an inpatient facility for further treatment. 

As I have pointed out in previous notes, we now have the following continuum for routine to emergent healthcare in larger cities: office visit to a PCP or visit a walk-in clinic for simple matters > urgent care clinics for minor injuries or illnesses > free-standing ERs for serious problems (these may require transport to a nearby hospital) > typical hospital ER visit with possible inpatient admission. There is also a gradient of cost across these facilities. This is important for patients with no health insurance or a high-deductible policy to understand. Urgent care facilities provide treatment at a fraction of ER costs (see: Rapid Growth of Urgent Care Clinics; Cost Competition for Hospital ERs). This complex health delivery system puts pressure on consumers who often need to perform self-triage in order to get themselves to the best facility for their problem.

The "Illogic" of Employer-Sponsored Health Insurance

Uwe Reinhardt has published an op-ed piece in the NYT about the illogic about employee-sponsored health insurance plans in connection with the recent Supreme court decision (Burwell v. Hobby Lobby) (see: The Illogic of Employer-Sponsored Health Insurance). Below is an excerpt from it:

...[T]he premiums ostensibly paid by employers to buy health insurance coverage for their employees are actually part of the employee’s total pay package...and that the cost of that fringe benefit is recovered from employees through commensurate reductions in take-home pay. Evidently the majority of Supreme Court justices who just ruled in Burwell v. Hobby Lobby case do not buy the economists’ theory. These justices seem to believe that the owners of “closely held” business firms buy health insurance for their employees out of the kindness of their hearts and with the owners’ money. On that belief, they accord these owners the right to impose some of their personal preferences...on their employee’s health insurance. In the ruling, the owner of Hobby Lobby, a chain of craft stores, gained the right not to include certain contraceptive goods and services in the insurance bought for employees, because use of these services conflicts with the owner’s Christian beliefs. Although the justices argue that their ruling is narrowly confined to contraceptive services, one must wonder what other items other business owners in the future may seek to jettison from benefit packages on the basis of this or that professed religious belief. The ruling raises the question of why, uniquely in the industrialized world, Americans have for so long favored an arrangement in health insurance that endows their employers with the quasi-parental power to choose the options that employees may be granted in the market for health insurance....Furthermore, the arrangement induces employers to intervene in many other ways in their employees’ personal life – for example, in wellness programs that can range from the benign to annoyingly intrusive, depending upon the employers’ wishes.

The illogic of employee sponsored health insurance, explained by Reinhardt, is that the employer take some of the money normally paid to an employee as salary and uses it instead to buy health insurance for that employee. In so doing, the company gains certain opportunities and advantages that it would not normally have. These include the ability to limit the number of health insurance plans from which the employee can choose or the opportunity to not cover the cost of contraceptive goods and services because this is antithetical to the company owner's religious beliefs.

Why and how did employee-sponsored health insurance evolve in the first place? Some of the labor unions favored such a system because it constituted a bargained-for benefit that did not count as employee salary. Employees favored this approach because they received benefits that were not taxed. Legislators liked it because is provided broad health insurance for workers with less federal red tape and control than government-run health systems.

I personally have mixed feelings about what Reinhardt calls the "annoyingly intrusive" demands in wellness programs. I think that the obesity epidemic in the U.S. is one of our biggest public health crises. I don't believe that the majority of overweight Americans are willing or able to reduce their weight and improve their health. It's certainly big-brotherish but I do like employer programs that encourage weight loss. The employers like them because they saves them money and avoids unnecessary absenteeism.

Algorithm Reduces Unnecessary CT Scans in Suspected Pediatric Appendicitis

In a recent note, I discussed how radiologists can use an algorithm to predict the likelihood of cardiovascular disease in chest CTs despite the fact that the procedure was not ordered for this purpose (see: Chest CT Used to Predict the Possibility of Future Cardiovascular Events). The clinical labs have used LIS-based algorithms, often called rules, for decades to prompt reflex testing and also to reduce unnecessary duplicate lab test ordering. A recent article discussed the use of an algorithm to reduce unnecessary pediatric abdominal CT's use in suspected appendicitis (see: Algorithm Cuts Pediatric CT Use in Suspected Appendicitis). Below is an algorithm from it:

A simple algorithm including components such as physical exam and ultrasound can help diagnose appendicitis in children and reduce the need for computed tomography (CT), researchers say. The algorithm, "built upon early involvement of the pediatric surgeon . . . decreases the use of imaging, including CT, without compromising diagnostic accuracy,"....Dr. Abdalla E. Zarroug...say use of CT in equivocal cases has increased, because its accuracy is reportedly above 94% - but "multiple studies" have suggested "that blood, brain, and solid organ cancers will develop owing to radiation exposure associated with CT."

To reduce use of CT in the emergency room in such cases, the team developed the algorithm. Among its elements are pediatric surgery consultation without any imaging in patients with unequivocal history, and physical exam and consultation prior to CT for patients with equivocal history, physical exam, and ultrasound results.

To evaluate the utility of the approach, the team examined five years' worth of data on 331 pediatric patients who had appendectomy after presenting to the emergency department. In the two years before algorithm implementation, 135 patients (40.8%) underwent appendectomy; the other 196 (59.2%) were seen in the three years after implementation.The use of CT fell significantly from 38% before algorithm implementation to 19% thereafter. The negative appendectomy rate increased slightly but not significantly from 9% to 11% after implementation. 

For me, the bottom line here is the appropriateness of seeking a surgical consultation before ordering a CT on a pediatric patient. Because the CT rate fell dramatically in the study, we can assume that the surgeons were able to make the correct diagnosis at the bedside without the CT with only a small rise the the negative appendectomy rate. Although this seems obvious, I think we are beginning to see a broader use of algorithms prior to ordering expensive imaging procedures and perhaps greater emphasis on the development of bedside diagnostic skills.

New Challenges for Pathology Informatics in an Era of Healthcare Reform

I am in the final stages of preparing a lecture to deliver at the Sunquest User Group (SUG) this week in Phoenix. The topic that I picked for my lecture is how pathology informatics (PI) can be used to respond to the cost-reduction pressures of the ACA and other healthcare reform initiatives. In the process of thinking about this topic, I become much more aware of how much pathology informatics has been changing recently. My goal in this this short note, is to begin to summarize the changes that I see occurring in PI. I will refer to these changes as a new pathology informatics model.

Let's start this discussion with what I think are the major pressure points on pathology and pathology informatics that are prompting changes:

• Healthcare reform in its various forms including the ACA and ACOs. The challenge here is to perform lab tests faster, better (i.e., higher quality), and less expensively.
• Dramatic advances in the science and technology of genomics and molecular medicine, particularly cancer genomics. This results in an enormous increase in the need for data storage and computerized data analysis.
• The wider adoption of digital pathology that will undoubtedly occur in the next couple of years. This trend, in turn, will increase the need for more data storage and, in time, will lead to a need for image search.
• Wider deployment of EHRs, often paired with a preference for an enterprise-wide-solution (EWS). This shift can sometimes lead to the deployment of a less functional LIS provided by the EHR vendor. This shift is putting  pressure on the classic best-of-breed LIS vendors whose long-standing relationships with hospital pathology departments may be disrupted. 

As a result of these pressures and the demand for new computerized solutions in pathology, I see pathology informatics expanding and also splitting into three practice areas. For the purpose of this discussion, I will refer to them as: research pathology informatics (RPI), clinical pathology informatics (CPI), and management pathology informatics (MPI). What I call RPI has been previously referred to by Mike Becich as computational pathology. RPI addresses computational problems in bench research. Right now, there is an intense focus in genomics, particularly cancer genomics.

One of the major tasks of CPI practitioners is to help manage the test-ordering and test-reporting relationship between clinicians and the clinical labs. Two of the most challenging issues here are to encourage optimal ordering by clinicians and to improve the formatting of test results in EHR lab reports. MPI addresses lab managerial issues such as how to  staff the various labs across the work shifts to accommodate varying test workload. MPI is largely the domain of lab managers, lab scientists, and medical technologists with some pathologist oversight.

In subsequent posts, I will continue to write about various other aspects of the emerging pathology informatics model, always linking back to this original piece.

Rapid Growth of Urgent Care Clinics; Cost Competition for Hospital ERs

I have posted a number of notes about walk-in health clinics which are usually located in chain drug stores and staffed by nurse practitioners (NPs). The business model for them is to treat routine minor problems. A recent article discussed the rapid growth of urgent care clinics, many of which are attracting venture capital funding (see: Race Is On to Profit From Rise of Urgent Care). These latter facilities, in comparison to walk-in clinics, are staffed by physicians and offer a wider range of services. A recent article raised the issue of how to understand the mission and scope of services of urgent care facilities. Below is an excerpt from it:

Urgent care is a low-margin, high-volume proposition....The national average charge runs about $155 per patient visit.....Urgent care clinics also have a crucial business advantage over traditional hospital emergency rooms in that they can cherry-pick patients. Most of these centers do not accept Medicaid and turn away the uninsured unless they pay upfront. Hospital E.R.s, by contrast, are legally obligated to treat everyone. But as urgent care centers expand their reach, regulators in some states are scrutinizing their activities. While some states require the clinics to be licensed, most do not. It is unclear whether such urgent care centers offer better or worse care than other providers.....The average charge to treat acute bronchitis at an urgent care center in 2012 was $122, compared with $814 at an emergency room, according to data on the website of CareFirst Blue Cross Blue Shield....The price of treating a middle-ear infection was $100 versus nearly $500 in an E.R. Such cost differences matter not only to commercial insurers, but also to consumers with high-deductible health plans. Still, just how quickly urgent care is proliferating is difficult to measure. The Urgent Care Association of America, which represents more than 2,600 clinics, estimates there are more than 9,000 clinics in the United States....But a bigger issue, he said, is that the industry lacks clear criteria about what exactly urgent care means.“Just because a physician’s office extended its hours doesn’t make it urgent care,” [an expert] said. “To me, urgent care means you can do X-rays, that you can do sutures, maybe you’re open one weekend day, plus one or two evenings.” Regulators in some states are struggling with that question and others as well. In Illinois, for instance, the authorities restrict the use of the word urgent, so clinics there are called “immediate care” facilities. Other states have weighed proposals on whether urgent care facilities should be required to accept Medicaid or uninsured patients. Despite concerns of possible increased regulations, companies are lining up to buy urgent care groups.

I would like to comment on the question of whether a state could or should compel urgent care clinics to accept Medicaid or uninsured patients. Public hospitals can be forced to accept some uninsured and Medicaid patients on the basis of their non-profit status which is granted as compensation for their "charitable" activities. I have commented on the fact that this has become a charade for many health systems (see: Non-Profit Hospitals Drift from Their Mission Despite Subsidies; Cities Begin to Question Non-Profit Status, Tax Breaks of Their Hospitals). I'm not a lawyer but it seems to me that a state legislature can't force a for-profit, urgent care clinic to accept a class of patients who are unable to pay for the services being offered. Why should they be treated differently than any other business offering services for a fee?

This question may begin to sort itself out as a greater number of Medicaid patients are being provided health insurance under ACA (Obamacare). According to the article cited above, urgent care facilities are providing services for a significant lower price than hospital emergency rooms. Because of this, health insurance companies are encouraging their policy holders to use these facilities over hospital ERs. Hospitals may begin to feel the competition as the number of urgent care clinics increases.

Most importantly is that we need to develop a good definition for urgent care facilities, establish a means to assess the quality of care that is provided by them, and educate healthcare consumers about when to seek care for relatively simple problems in urgent care clinics as opposed to ERs. The health insurance companies can provide a great service by addressing these issues.