iPathology

The MSM Pick up the Mayo/Medicare Story

The Wall Street Journal has an editorial today on the decision by a Mayo primary care clinic in Glendale, AZ to drop acceptance of Medicare as a payment type. This is story that, as they say, "has legs".

Mayo Clinic to Stop Accepting Medicare Patients at a Primary Care Site

I read with much interest the report in Business Week that Mayo Clinic will, for a 2-year trial period, stop accepting Medicare patients at its primary care clinic in Glendale, AZ. Although individual physicians and physician groups have been opting out of Medicare for years, few large health care systems have taken this approach. According to the report in Business Week, Mayo lost $840 M in treating Medicare patients in 2008. Medicare patients who want to continue their care at this clinic will have to pay by some other means.

It's surprising to me that the mainstream media haven't picked up on this story. Medicare is a social contract between the government and seniors. If the third party in the equation, namely, the healthcare industry, refuses to participate then this becomes a major national problem.

More on Reference Ranges

I recently referred to an editorial in the Annals of Clinical Biochemistry that outlines ways to establish reference ranges and their attendant advantages and disadvantages. The authors of an editorial in January's Clinical Chemistry (55:15-17, 2009 [subscription required]) advocate "a new way of thinking about the relationship between biomarker measures and clinical decision-making". They envisage the use of lab results to generate a prediction of risk of disease, which actually sounds a lot like existing likelihood ratios. These predictions will be based on data other than simply a lab measurement, for example, they might include the patient's family and social histories, results of imaging studies, and even the patient's desire for treatment. A result might be of the form that given the results of the lab studies, imaging, history etc. the patient has X% risk of having heart disease, cancer, etc. Certainly I agree with the assessment that traditional reference ranges have important limitations. To move beyond reference ranges to presenting the clinician with more useful data, specifically data that integrate findings from the history, physical exam, imaging, treatment desires etc. will take a lot of effort, much of which will be informatics related.

"Rainbow Drawing"

 I first came across the term "rainbow draw" quite recently. It refers to the practice of drawing one of each blood tube type from a patient without a clear understanding of which tests are going to be performed. Some tubes have anticoagulants, of which there are there are several types (e.g., heparin, EDTA, citrate), some have serum separator gels, some are just plain tubes and so on. These tubes are recognizable by the different color of their caps and so the allusion to a rainbow. We use different tubes because some assays require serum (e.g., chemistry tests), some require anticoagulated blood (e.g., complete blood counts), some require plasma (e.g., coagulation assays) and so on.

A rainbow draw is a strange approach to sample collection! Some of these tubes are quite specialized, and it's unlikely that most patients would routinely need, for example, a tube collected for analysis of heavy metals. I understand that having to re-draw a patient is time consuming and perhaps uncomfortable for the patient, but drawing one of every tube is a waste of tubes, a waste of blood, and a substitute for rational thinking about which tubes are needed for different laboratory tests, and which tests are really needed.

Reference Ranges

An interesting editorial on the topic of reference ranges can be found in the January edition of the Annals of Clinical Biochemistry (46) 1-2, 2009, which also includes a couple of interesting papers on the approaches using "healthy" populations and real patient data. The editorial writer comments on these various approaches to defining reference ranges:

1. A classic based approach is to draw samples from a well defined cohort(s) of healthy people and typically take the middle 95% of values (mean +/-2 SD). This is required if there are variations between people of different age, gender, race etc. There are limitations to this approach: Who is healthy? Should there be a separate reference range for symptomatic people? How do we define ethnicity in populations that are composed of people of mixed ethnicity? For how long are samples stable prior to analysis?

2. The use of patient data to establish reference ranges. This may seem at first sight to be an odd way to establish a reference range. Almost by definition, patients have some health problems. On the other hand, many patients do in fact have concentrations of many analytes that are within the ranges found in healthy people. If one excludes the "outlier" values, it is possible to derive a reference range that at least approximates that seen in healthy individuals. The other objection to the use of patient samples is that there may be pre-analytical variation that is not seen in carefully collected samples used solely for the purpose of establishing a reference range. The answer to this objection is that "real" patient samples are usually drawn and transported under less than ideal conditions. If there is variation seen because of pre-analytic factors, then shouldn't it be reflected in the reference range?
A big advantage of using real patient data is that large numbers of data points are available and, importantly, from groups such as children, from whom it is generally extremely difficult to get samples to do a reference range study.

So we have a "purist" approach and a "pragmatist" approach to reference range establishment. (Yes, Laboratory Medicine has its own set of disputes!) Moreover, those are not the only ways to think about lab values that require a clinical response. Some people advocate Decision Limits. In a nutshell, these are values that trigger a clinical decision (e.g., a diagnosis or a therapeutic intervention). We talked about some of these in the context of cholesterol and glucose, and how those values that have clinical significance are not evident from a simple statistical analysis of the distribution of values in health or disease. These are what I refer to as a "reference range by committee".

When it comes to reference ranges, all of these different approaches need to be considered; there is no one approach that is clearly right or wrong in all circumstances.

Thoughts on Pathology and Laboratory Medicine as a Career

As the Fall rolls on, senior medical students will be choosing their fields and applying for residency programs. It's an exciting and critically important time in their lives. The choices made between now and the Match day will determine the course of their lives.

What about Pathology as a career? Ever thought about it? What do Pathologists do?

Pathology is a very broad field that is commonly said to bridge the divide between basic science and clinical medicine. In fact, it's far more than that. Pathology is an incredibly dynamic area. This may come as a surprise to those who think of pathology as all about looking at slides and doing autopsies. While those are important and essential for patient care, which is the field that is taking the new genomics and applying to medicine? Or the new proteomics? The answer is these are being applied in pathology, particularly in the field known as clinical pathology. That's the field that includes the medical direction of clinical laboratories. It's also called laboratory medicine. A clinical pathologist may practice some anatomic pathology, but most clinical pathologists have a specialty interest in one of the areas of the clinical laboratories such as clinical chemistry, molecular diagnostics, hematology, cytogenetics, coagulation, blood banking, immunology, or microbiology. That's a lot of areas each of which has plenty of depth. Some of them involve primarily laboratory work, others, like coagulation and blood banking involve patient care to one degree or another. Molecular diagnostics is said to be the bridge between clinical pathology and anatomic pathology. Increasingly, tumors are being studied at a molecular level, providing data that complements morphology and offers information for diagnosis and sometimes prognosis. This is where the fruits of the human genome project are being applied. It's a very exciting field that is at the cutting edge of applying science to patient care.

What's the training like to become a pathologist? In the U.S., most people take 4 years of residency in anatomic and clinical pathology in accredited programs and are then eligible to apply to take the American Board of Pathology exams. Subspecialty training is available in academic medical centers around the country. To my mind, what distinguishes programs is usually not the anatomic pathology which tends to be of a uniformly good standard, but the level of involvement with clinical pathology. Does the program have full-time clinical pathologists? Who runs the clinical laboratories? Here are some questions to consider if looking at a pathology program: how many anatomic and clinical pathologists are directly involved in the teaching program? Is there a real interest in clinical pathology or is a part-time activity? What are the opportunities to be involved in cutting edge research? On anatomic pathology rotations, do residents get to see the cases from start to finish? Are the "most interesting" cases reserved for fellows? (A red flag if you're a resident). What is the activity in molecular pathology? If it doesn't exist, I'd look at other programs: it's not a good idea to begin a 30-40 year career in pathology today and not know about molecular pathology.

What are the job prospects like? What do pathologists earn? I'll talk about these more in later note.

For more information see the American Society for Investigative Pathology website.

Survey Sounds the Alarm on Physician Labor Trends

A recent survey conducted by Merritt Hawkins and Associates of physicians aged 50-65 reveals several striking and alarming findings. But before looking at the survey findings, let's remind ourselves of a few important points. First, this group of physicians is presumably at the peak of their careers in terms of clinical experience. Second, nearly one-half of all U.S. physicians are over 50 years of age, so it's a very large group of professionals. Third, the U.S. population is rapidly "graying" and the need for physicians will never have been greater than it will be in the coming decades. We face a physician shortage that may range from 100,000-200,000 physicians by 2020.

So here are some of the findings that are very troubling.

1. In the next 1-3 years, nearly one-half of physicians surveyed plan to either retire, take a new (non-clinical) job, or cutback significantly on their clinical work.

2. Only 10% agree that their work is "very satisfying".

3. 18% have already closed their doors to new patients.

4. A clear majority (57%) would not recommend a career in medicine to their own children.

Unfortunately, there are no specific data on pathologists in the survey, but in my personal experience, I'd guess that the degree of job satisfaction among pathologists is significantly higher than among primary care physicians. I think this is attributable to many reasons among which I'd cite more regular hours, less paperwork, a more structured working environment, and possibly greater intellectual stimulation given the dynamic developments in laboratory testing.

If the findings of this survey are accurate, the U.S. is going to face a crisis in physician health care delivery in the next few years. The reasons for the high level of dissatisfaction have to be addressed.

The Merritt Hawkins report can be accessed here.

Should HPV Testing Replace Cytology for Screening for Cervical Cancer?

This week's New England Journal of Medicine (357:1579-88, 2007) reports a very important study that looks at the performance of HPV molecular testing for screening for grade 2 and 3 (i.e., high-grade) cervical intra-epithelial neoplasia. The population consisted of over 10,000 women aged 30-69 in Canada with good access to health care. Sensitivities for HPV and cytology were 94.6% and 55.4%, respectively. Specificities were 94.1% and 96.8%.

Cervical cancer screening by the use of the Pap smear has been one of the best examples of a successful cancer screening program in history. With current practice, it's common that HPV testing is used to clarify cases of ASCUS (identified by cytology/cytopathology) rather than as a primary screening technique. This study (and others) suggests that HPV testing could be a primary screening modality, although more data are needed to reach that conclusion with certainty.

From a laboratory perspective, screening programs need high sensitivity, and the difference between molecular HPV testing and cytology is striking. On the other hand, there is variation in the number of HPV types that can be detected by different molecular methods and the method used in this study may not be the most sensitive. Different assays have different sensitivities and specificities (see J Clin Micro 45:2130-7, 2007 for example). This study demonstrates that in vitro molecular testing can, in certain situations, be a viable alternative to microscopy. This last point emphasizes the need for pathologists to be closely involved with molecular pathology and its implementation in hospital laboratories or they risk being marginalized in the changing diagnostic landscape. For many cytology technicians and cytopatholgists, Pap testing (or one of its liquid counterparts) is the major professional activity of the daily workload. A widespread change from morphology to in vitro testing for HPV could pose the possibility of sudden and substantial disruptions to professional activities.

Microsoft and Health Care Software

Writing in the Wall St. Journal on October 7, 2007, Bill Gates rightly points out the significant deficiencies with the state of health care informatics and its adverse effect on the quality of patient care. What might a company like Microsoft offer to this field? I submit that Microsoft is exactly what we need to make some sense out of the mess we face in health care informatics. We need a common software product that is as ubiquitous as Word or PowerPoint. We need someone with deep pockets like Microsoft to make the initial investment, to implement standards that have been agreed upon such as HL7, and to introduce some meaningful competition into a field that needs more of a driving sense of the importance and urgent need for innovation. Microsoft has been criticized by many for lacking a spirit of innovation in its flagship products, Windows and Office, but the truth is that they work as expected for most users, and it would be difficult to imagine how global businesses could function without them. If only the same could be said of health care software. Microsoft's entry to this field is to be welcomed.

Board Recertification Should be All or None

American specialty Boards play an essential role in setting standards for basic medical competence for graduates of residency programs. Historically, passing a Board exam was the final milestone to beginning a lifelong career in a medical specialty. In the last 10 to 20 years, however, Boards began to issue certificates which were time-limited, generally to 10 years. Under this scheme, a two-tier system of physician certification is established, namely that candidates who have passed the board exam more recently hold a time-limited certificate whereas physicians who took and passed the boards years or even decades earlier enjoyed the privilege of lifelong board certification. This dichotomy is not only anomalous but clearly unfair to more recent graduates of residency programs. There is no reason to believe, for example, that more recent graduates of residency programs are any less up to date with current medical practice than are their more senior colleagues. In fact, one could well believe that the opposite is true. For many physicians, there is a tendency toward specialization and therefore an increasing distance from the knowledge base of some areas of practice.

Given the rapid advances in biomedical research, it is probably a good idea to require periodic recertification of all physicians in their specialty area, and 10 years seems to be an appropriate interval. Ensuring that physicians are up to date with their field is consistent with the current trends towards emphasis on quality in the delivery of healthcare. This means that for a typical physician, he or she would be required to re-certify about three or four times in the course of a career. For those physicians who hold lifelong certificates, recertification in pathology is currently optional. Whether it remains that way is uncertain. It is entirely possible that hospital staffing committees or payers will require that all practicing physicians undergo periodic recertification if it is available. One point seems clear: if physician recertification is going to be required, it should be required for all physicians.