Hypertension, HEDIS, Excessive Blood Pressure Lowering, Polypharmacy and Implications for Care & Disease Management

Just what do the two numbers in a 'blood pressure' (for example, 120/80) really mean? What happens if the pressures are too high? Suppose just one number is high... how should it be addressed? How should the quality of care be measured among persons with an elevation in just one number? Can overzealous pursuit of high blood pressure lead to bad outcomes and, if so, how should that be measured in populations?

Thanks to a recent publication in the American Journal of Managed Care, your Disease Management Care Blog addresses the controversy.

The DMCB thinks of the two numbers as the highest and lowest measured pressures in the body's arteries that are generated by each heart beat. When the heart muscle contracts, the pressure increases until it peaks. Then the heart relaxes to fill with blood for the next pump. The blood pressure falls during this time until the heart begins to squeeze again. Therefore, think of 'blood pressure' as the peak increase and bottoming out of the pressure that is generated by each heart beat. Most of the time, a person's blood pressure is in between the top number (the systolic blood pressure) and the bottom number (the diastolic blood pressure). We're constantly bouncing between the two extremes.

It's been known that most people seem to have a peak or systolic blood pressure of 120 millimeters of mercury and a bottom or diastolic blood pressure of 80 millimeters of mecury. When those pressures increase, there is increased wear and tear on the inside walls of the arteries, leading to heart attack, strokes and kidney disease. Among persons without diabetes or kidney disease, decades of research have shown that a blood pressure of more than 140 systolic or 90 diastolic (the short hand being '140/90') results in significant enough damage to warrant treatment. If diabetes or kidney disease is present, the treatment threshold numbers are even lower at 130/80.

Which brings us to today's population-based care management conundrum: what should patients and treating health providers do with the category of high blood pressure where there is an elevation in only one of the two blood pressure measures? The reason that is important is because treating one high blood pressure number may cause the other to become dangerously low. For example, (when diet and exercise are not enough) pursuing a systolic blood pressure of 130 or higher with drugs in a person with diabetes could result in their normal diastolic blood pressure going below 70. According to this paper (the info is summarized on Figure 1), that can lead to an increased risk of heart attack and stroke.

This is not just a question for patients, providers or disease/care management organizations. It's also an important wrinkle in the national pursuit of health care quality. For example, a strict interpretation of the National Committee for Quality Assurance (NCQA) HEDIS® measures for successful blood pressure control suggests all persons with diabetes should have blood pressures less than 130 systolic and less than 80 diastolic - with no allowance for the unlucky patients with a 'successfully' treated systolic pressure that is less than 130, causing a concurrent diastolic blood pressure below 70.

Another criticism of the hypertension NCQA HEDIS® measure is that it doesn't recognize that sometimes blood pressure pills simply don't work. Most clinicians stop prescribing additional medications when the patient is on three. Once a patient reaches that point, additional pills are unlikely to work but are more likely to cause side effects.

This can be a problem, because 'all or nothing' blood pressure quality like less than 130 and less that 80 metrics - while well meaning, relatively simple to measure and based on the science - fail to capture the more subtle realities of of hypertension care that are also tied to outcomes (like excess heart attacks) and quality of life (medication side effects).

Which is why this paper published in the latest January 2010 American Journal of Managed Care is important. The authors looked at nine community-based general internal medicine clinics' patients 'of an unnamed academic healthcare system,' thanks to having access to an 11,000 person registry that captured the blood pressure (BP) readings of each and every patient. Two pools of patients were studied: 125 with diabetes who had a recent BP that did not meet the HEDIS criteria of less than 130/80 but were less than 140/90, and 125 patients with BPs or 140/90 or greater. In examining their electronic medical records, they found there were 31 (or 25%) patients in the first pool that were taking three blood pressure prescription medications and/or had a diastolic blood pressure less than 70; there were 43 (34%) patients in the second pool on three or more prescription medications and/or had the low diastolic blood pressure. Among those aged more than 65 years, the numbers were even higher: 58% in the first pool and 60% of those in cohort B took 3 or more antihypertensive medications and/or had the low diastolic pressure.

From a pure unrefined HEDIS® measurement standpoint, having a quarter to one thrid of patients with 'out of control' blood pressure would look bad. DMCB readers have long known there is more to the story. This AJMC study helps us understand the problem better.

The NCQA's Executive VP Greg Pawlson and Partners Healthcare's Thomas Lee would seem to agree. They penned an accompanying editorial in the same issue of AJMC that explains that when it comes to quality measures like those used by the NCQA, '100% performance is not the goal... that clinical judgement should be used' in applying the measure to populations and not be used to 'dictate the care of any individual patient.' They also suggest that the NCQA is open to modifying its measurement guidelines and look forward to the day when real time registries can provide more detailed measurement options.

Hear hear says the DMCB.

What does this mean for disease management organizations (DMOs)? Since DMOs also typically maintain high performance registries, they should already have access to the level of detail that can not only report the standard 'blunt' HEDIS® measures but also gauge the level of polypharmacy over-treatment or excessive BP lowering. Being able to educate your customers about these subtleties and report these data will be a competitive advantage, especially if the NCQA modifies its HEDIS® criteria.

A Tale of Two Diabetics

Meet Homer. His appetite for doughnuts and aluminum wrapped carbonated carbohydrate-rich beverages has finally caught up with him. His doctor has told him that he's overweight and has diabetes mellitus. An oaf he may be, but he’s a lovable well-meaning oaf who does his best to follow his doctor’s advice most of the time. He’s been told by his doctor about the role of diet, exercise, medications and regular follow-up. He remembers little of it.

Homer’s neighbor Ned hasn’t been immune from exposure to Fatland either. A victim of one too many yummylicious Church suppers, his waist line has also reached critical mass. He is very attentaroonie to the need for blood glucose control, has bought a meter and is already thinking of giving that eye professional he saw just last month a call to see if there was any sign of a new word he learned on line i.e., ‘retinopathy.’ He’s been told by his doctor about the role of diet, exercise, medications and regular follow-up. He’s tried to remember what he’s been told. He remembers little of it.

Who is going to have the better outcome – Ned or Homer?

While Ned is the obvious choice, don’t dismiss Homer, especially if he gets the kind of health care coaching that is tailored to his life-style preferences. While it’s always hard to predict just how Homer will process things, given his preferences, he’d probably be reluctant be hassled by the polypharmacy combination of medicines of dubious value and heightened risk of side effects that only marginally lower his A1c to that one-size-fits-all guideline value of 7.0% or lower. While he’ll probably neglect getting his yearly eye examination, chances are likely that his vision will do just fine. Because he works at a nuclear power plant, Mr. Burns – not out of any soft hearted notions of niceness but out of a hard assessment of a likely return on investment - has probably invested in an aggressive on-site wellness program that has made donuts far less available. Last but not least, Homer is high risk and has been tagged by a disease management organization as someone that warrants regular phone calls. Homer’s nurse has determined that Marge can be a resource in modifying Homer’s dietary habits.

By-the-book Ned, in the meantime, is probably going to go along with the ADA recommendation that he get his A1c below 7%, even if he has to take a combination of three different medicines to do it. While he’s worrying about all those side effects, the increase in his visits to the doctor is going to prompt additional testing and referrals for other long dormant conditions, including that vague pain he’s had in his low back and his concern that that long standing mole could be something serious. And by the way, Ned’s business pays for a bare bones health insurance program with a high deductable and no disease management support. There are no on site wellness programs and Ned doesn’t have access to any disease management.

The DMCB will put it's money on Homer.

Wall Street, Stress and Diabetes.

Good grief. Major financial houses are vaporizing. Stock prices are tanking. Dire headlines are extending across not three but all six columns of the Wall Street Journal. And if Mad Money Cramer's reaction is emblematic of the resulting emotional turmoil among the financial traders, it’s likely that there’s some major stress out there. Since there is no reason to believe that workers in the major exchanges are any more immune to chronic illnesses like diabetes, the Disease Management Care Blog wonders if level of stress can really lead to poor chronic disease control. In these times of high anxiety, are there more polydipsic and polyuric traders out there? If so, what is the role of population-base approaches to care?

The answer to that question is more complicated than readers may imagine. It is well known that depression and anxiety are more prevalent among persons with diabetes mellitus. Whether having diabetes causes stress, or if the stress causes the diabetes, or if other factors cause both is unknown. Either way, persons prone to anxiety will experience more of it when they are stressed. But what is the impact on blood glucose control among persons with diabetes?

One way to answer the question is a clinical trial in which patients are intentionally exposed to stress. This was a study involving persons with Type 1 diabetes mellitus. Interestingly, if they were fasting at the time of the exposure, their blood glucoses did not increase. However, stress applied following a meal showed a delayed but significant increase in the blood glucose.

Such a clinical trial has not been done among persons with the more common (including on Wall Street) Type 2 form of diabetes. However, check out this natural experiment from Japan. The DMCB leaves it to readers to decide if earthquakes compare to the temblors roiling the U.S. stock markets, but this study showed a life threatening 7.2 Richter stress caused a widespread bump in the A1c among persons with diabetes compared to persons experiencing a milder 4.2 earthquake in another part of the country. The authors suggest the cause was a combination of disruptions in the neuroendocrine system as well as an impaired psychological ability to adhere to diet, lifestyle and medications.

Given these data, it may be tempting to equip a battalion of disease management coaches with bromo-seltzers, Xanax and insulin and parachute them into Manhattan. A better approach may be to alert anxiety-ridden patient-enrollees and their disease management nurses to the important role of emotional stress in blood glucose control. Awareness may be half the battle. Formal stress management interventions may also help. So would opening the Fed Window, lowering interest rates and reducing the federal deficit. Cramer may prefer the latter interventions, but for his colleagues with diabetes, it may be more realistic and worthwhile to stick with the former.

Diabetes, ADVANCE, ACCORD and the Timely Perspective of Dr. Gauss

If you are a regular reader of the Disease Management Care Blog, you already know about ACCORD. This randomized prospective study of tight versus not so tight blood glucose control among persons with diabetes showed an unexpectedly increased death rate associated with tight control. While the preliminary results initially appeared online, the New England Journal of Medicine has now published a full report. The mean A1c was 6.4% in the tight control group and was 7.5% in the not-so-tight control group. While there was a non-statistically significant decline in heart attack, stroke and cardiovascular death in the group with the lower A1c, the death rate was statistically higher: these patients were less likely to have a stroke or heart attack, but it if it did happen, it was more likely to be lethal.

At about the same time ACCORD was announced, there was another study called ADVANCE that was also randomized and prospective and also designed to test the merits of tight versus not so tight blood glucose control. It differed, however, in that patients were initially started on a drug called ‘glicazide.’ In ACCORD, docs were able to choose the drugs. In ADVANCE, there was no difference in death rates between the two groups but the tight control group had fewer kidney complications. The rate of heart attack and stroke between the two groups was not different.

If you are confused by the contrasting results, welcome to the club. As Dr. Cefalu points out in his accompanying editorial, there were differences in the rate at which patients achieved their targeted A1c levels, the medications used,the duration of follow-up and the degree of weight gain. Whether one some or all account for the confusion will be answered in future studies.

The DMCB preferred to focus on the what-does-this-mean-for-diabetes-guidelines commentary by Drs. Krumholz and Lee. Wondering if the differing medications had much to do with the disparate ACCORD and ADVANCE outcomes, they have two recommendations:

1. Treatment targets (for example, the American Diabetes Association recommends an A1c of 7%) need to be paired with recommendations on how to get there. Some drugs may be better than others.

2. Treatment targets need to be tailored to an individual patient’s risk. For example, ADVANCE tells us that an increased pre-existing burden of cardiovascular disease may warrant avoiding tight blood glucose control.

The DMCB cannot disagree with these eminent editorialists, but humbly offers an additional population-based point of view that contrasts with the ‘guideline-ish’ one-patient-at-a-time perspective of Drs. Krumholz and Lee. By the way, the pic above is of Herr Professor Gauss, of population-distribution fame. He'd probably appreciate what follows.

Assuming that an A1c target of 6.4% results in a distribution of A1cs around a mean, it is possible that persons to the left will have an even higher rate of harm. Imagine, then, that docs serving a population in a network are successful in achieving an average state-of-the-art A1c 7%. Assuming there is a distribution around THAT mean, the result is that there will be a fraction of patients that are being exposed to a low A1c, some as low as 6.4%, which ACCORD tells us results in a greater rate of lethal heart attack and stroke.

This potential for an increased risk of harm for some persons in a population-based A1c that otherwise 'looks' good at 7% can be addressed one of two ways:

1) move the curve to the right (say to a mean A1c of 7.5%). Before you blanch at this apostasy, consider that there are other diabetes treatment recommendations that have a more flexible approach to the A1c.

2) narrow the distribution around that mean, so there are fewer persons with low blood glucoses.

Either way, fewer patients are exposed to harm. While the first strategy means there will be patients to the right of the mean with higher A1c, the ‘harm ratio’ of the left versus the right of an A1c strategy of 7.5% is unclear. Of the two approaches, a narrower distribution is probably better.

Either way, the DMCB suspects savvy population-based approaches to care, backed up by the right kind of registries, patient education, disease management and physician incentives (among other things) can result in a better ‘distribution’ of A1cs with fewer deaths than the one-on-one approach advocated by the editorialists.

USPSTF: Blood Pressure Trumps Blood Glucose & the Implications for Diabetes and Hypertension Disease Management

Persons with blood pressure readings consistently greater than 135/80 should be screened for diabetes mellitus every three years, or so says the U.S. Preventive Services Task Force. When this headline first crossed the Disease Management Care Blog’s twin flat screen monitors, it thought the rationale was simple.

A high prevalence of undiagnosed diabetes among persons with hypertension should be the cause for alarm. Diabetes mellitus is present in about 9% of the U.S. population, its prevalence increases to more than 20% among persons aged greater than 65 years and is also associated with a high body mass index. Since these risk factors tend to cluster together, it makes sense to look for the condition, right? Earlier diagnosis would lead to earlier treatment and prevention of the complications of diabetes, right?

That’s not the case. Instead, the USPSTF logic is reversed and twofold. The first is that the presence of diabetes alters the preferred blood pressure to less 135/80, even if it means starting a lifetime of daily pills. The second is that it makes a difference as to which medicines are used. So it’s not a matter of diagnosing and then treating diabetes, it’s a matter of managing the blood pressure differently.

Don’t be surprised. Several studies including the U.K. Prospective Diabetes Study (UKPDS) and the Hypertension Optimal Treatment (HOT) Study demonstrated a strong link between blood pressure control and macrovascular complications, such as heart attack and stroke, among persons with diabetes. Up to 80% of persons with diabetes will die of macrovascular disease, so blood pressure control is a priority. In fact, it is probably more important than blood glucose control. To give you a sense of this, the very valuable “Number Needed to Treat” (NNT) blood pressure calculation, provided in this excellent Annals article, is an impressive 23 or less for all cause mortality, stroke or heart attack over ten years. Thiazide diuretics or ACE inhibitors (and frequently both, combined with other medications if necessary) should be used initially, versus other first line agents.

Note that there are no prospective studies that show control of the blood glucose level in diabetes changes the incidence of heart attack or stroke. Rather, blood sugar control is correlated with fewer “microvascular” complications, such as damage to the sensory nerves in the feet or kidney disease.

The DMCB wonders how this new recommendation would work for physicians in primary care settings:

Scenario 1: During the course of every one-on-one visit with patients, the physician tries to remember that a blood pressure reading that normally isn’t considered “high” should prompt a check of those past blood tests in the back of the chart and to order a screening test for diabetes, in addition to all the other things that need to fit into a 15 minute office visit. If really well organized, have a flow sheet in the front of the chart. Anyone without an appointment loses out.

Scenario 2: Have a standing order for the office nurse to review the charts’ labs and arrange for a screening test for diabetes if, during the course of the intake, the blood pressure is more than 135/80. Anyone without an appointment loses out.

Scenario 3: During the course of every one-on-one visit with patients, the physician gets annoying prompts from that new EHR that a blood pressure reading that normally isn’t considered “high” is high and a lack of any labs under the 'results' tab should prompt an order for a screening test for diabetes click here, in addition to all the other aspirin, cholesterol screening, mammogram and immunizations prompts – click heres that clutter the screen during the 15 minute office visit. Anyone without an appointment loses out.

Scenario 4: Physician fires up that new and improved EHR registry and uses some if-then branching programming logic to extract everyone with a mean of > 135 OR >80 over three visits in the two BP fields AND absent diagnosis of diabetes (look up the ICD 9) codes AND absent qualifying blood test over the last 365 days x2. Generate form letter to all patients meeting criteria and “blow in” the name and address from the demographic data fields. Blow in a screening lab order on hundreds of patients. The physician and the office staff deal with each one at a time when patients start calling with questions and when the physician needs to actually see the folks with evidence of diabetes.

Scenario 5: Physician tells the office manager or nurse to deal with Scenario 4. They tell the physician (s)he needs to contact the EHR vendor and find out how much it will cost to have this ad-hoc programming done.

Scenario 6: Physician awaits the arrival of a newly developed HEDIS measure for the number of persons with blood pressure > 130/85 (denominator) who have a screening blood glucose level (numerator). (S)he resists the flaky letter from the managed care organization listing patients, many of whom are not recognized, that the MCO believes meet criteria for measurement or intervention so that they can get NCQA accreditation. There is a change of mind when the flaky letter Ver. 2 outlines the terms of a new P4P initiative linked to this measure.

Scenario 7: The physician discusses this with the Medical Home trained staff and instructs them to work with the disease management vendor, who has the mojo to contact everyone meeting criteria after they’ve remotely accessed the electronic patient files in a HIPAA compliant way. Patients meeting criteria are contacted with letters, IVR and eventually live nurses who remotely arrange testing. Patients who have the labs done have been coached, and those with a fasting blood glucose > 126 (have diabetes) and a blood pressure > 135/80 are seen by your Medical Home staff and medications are started and adjusted using a standing order protocol that is safe and effective. Physician is in the meantime seeing sick people, but available if the protocol isn’t working.

A Type 1 Diabetic's Insights About Insurance, Quality and Cost (& an erratum re Lifemasters)

While DiabetesMine is a famous must-read blog for all things diabetic, the Disease Management Care Blog discovered this morsel at Finding Our Way. Ms. Erika also has type 1 diabetes and her latest blog is a telling essay that gives the patient's points of view on all these high falutin concepts about insurance, quality and cost. When I read this, I thought about:

Risk vs. retail: Can we be confident that the Material Girl's efforts are reasonably destined to save her and her insurance company money in excess of the $14,000 per year? Suppose a cheaper pump were used and testing was limited to 4 times a day? Cost would go down and the risk of increased claims expense might go up, but by not as much. Maybe the retail dimensions are more important: her insurer can use its purchasing power to gain discounts on the cost of supplies and share the expense outside notions of insurance risk. Reconciling both functions is difficult but it's the right thing to do.

Benefit design and silos: it's not clear if the yearly cap of $3500 applies to all costs or some; it's possible that "durable medical equipment" like pumps have a different cap. The point is that from the patients' point of view, it doesn't really make that big a difference. Money is money. Health is health. Maybe there is a role for 1st dollar coverage of 'no-brainer' health care like pumps.

Consumer Directed Health Plans or variants thereof: it's pretty obvious that Running Mama is going to blow right through her out of pocket cap in just a few months. If interpreted correctly, this new insurance could possibly represent a simple cost transfer from the insurer to the enrollee. On the other hand, it's clear the 'consumer' is now carefully weighing the pros and cons of high frequency testing and making rational economic decisions based on her values and life style.

The Doctors: Think docs cost a lot of money? Think again. Depressing isn't it? Of the 14 grand, her physician occupies only $500. Yet, that doc presides over a whopping amount of money. It seems to the DMCB that the doc deserves better compensation in general and should also be rewarded for making sure the $14,000 is spent in the best interest of the patient with dimensions that include quality and value.

Disease management: This patient is obviously doing such a good job with DM, if I were a vendor, I'd stay away and move onto the next patient. However, perhaps there is a future role for DM companies is to help persons navigate the insurance benefit design. This will be examined in a future post.

Thanks Erika, for sharing.

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Postscript: the DMCB has issued its first ever erratum (and hopefully last) on a prior post, mistaking Lifemasters for Healthways. The DMCB has made the necessary corrections & regrets the error.

Read the Disease Management Blog and Keep Up with the Peer-Reviewed Literature on Diabetes and Chronic Heart Failure

Holmes AM, Ackermann RD, Zillich AJ, Katz BP, Downs SM, Inui TS: The net fiscal impact of a chronic disease management program: Indiana Medicaid. Health Affairs 2008;27(3):855-64

The Disease Management Care Blog would expect nothing less than a prospective randomized trial on disease management from one of the Gods of General Internal Medicine. Thomas S Inui is among the authors of such a study recently published in Health Affairs. His prodigious biosketch can be found here. Note that he is a former President of the very academic Society of General Internal Medicine (SGIM), which has been curiously mute on the exciting and controversial developments in real world population-based health care. More on this in a future blog.

But let’s turn our attention to the study at hand. It was about the economic impact on disease management (DM) in an Indiana Medicaid population. Indiana has been looking at the role of DM for quite awhile. As patients were randomly enrolled in the program, they were followed over time and compared to patients who had not yet been enrolled, otherwise known as a staggered implementation. Over 800 persons with either diabetes or chronic heart failure were studied with an average of 21 months’ worth of data. Cost of the program (excluding start up) ranged from about $20 per member per month (PMPM) for telephonic care up to about $57 PMPM for nurse care management. High risk persons were assigned to the nurse care management, while low risk patients were assigned to telephonic care.

AmeriChoice ran the call center. The Indiana Primary Health Care Association provided the nurse care management

For CHF:

High risk PMPM savings vs. controls: $150 – not statistically significant

Low risk PMPM savings: $247 – statistically significant

For Diabetes:

High risk PMPM savings: - $144 (more expensive in the intervention group) – not statistically significant

Low risk PMPM savings: $3.80 – not statistically significant

The authors concluded that disease management was cost saving for the low risk heart failure group. They were unable to show savings in the high risk heart failure group or in either group with diabetes.

What does the DMCB think?

Once again, it’s possible to do credible research outside of research settings.

What’s true in Medicaid doesn’t necessarily apply to populations with other types of insurance. For example, a similar study in a commercial population showed diabetes disease management was associated with savings, while in an integrated delivery system, low risk heart failure disease management seemed to not result in savings. Go figure.

In their discussion, the authors expressed surprise that there were savings for low risk persons with CHF. For the DMCB, that’s still not that counterintuitive. Moderate amounts of disease may be more amenable to intervention. Persons with mild disease will do well no matter what you do, while those with advanced disease will have problems despite the best of care.

The authors also noted that the baseline characteristics of the control and intervention patients were imperfectly matched, which could have skewed the results. It’s also possible that higher numbers of participants may have achieved statistical significance. The DMCB also wonders if the protocols used to identify the 'high risk' versus 'low risk' patients could have been responsible or if the nurse protocols to manage the high risk heart failure patients or the diabetes patients weren’t up to snuff.

Diabetes and the Government Sponsored Disease Registry of New York City

Registries. Everybody loves ‘em. These data bases promise sorting, insight, planning, action and improvement, right? Government should not only support them, but maybe even sponsor them, right? Use them to create documents with maps, hm?

Not so fast. The April 28 edition of the Archives of Internal Medicine (not online at the time of this posting) has a well written pro vs. con debate on the topic. Specifically, New York City (that's a map displaying the burden of disease in the 5 boroughs) is requiring that all its laboratories forward A1c results and demographic data on all persons with a diagnosis of diabetes mellitus to the NYC Department of Health and Mental Hygiene. Once patients are in the data base, they will be given the ability to ‘opt-out’ of being contacted. If there is no opt-out, patients with an A1c greater than 8% will be alerted by letter and sent education materials. The ordering physicians will also receive alerts along with treatment recommendations.

This is a slight twist on a familiar subject for readers of the Disease Management Care Blog. This debate centers around government sponsored registries. There are still some important lessons.

The ‘pro’ article by Drs. Littenberg and MacLean of the University of Vermont has the all the usual arguments and then some. Registries have been used to conquer other scourges of mankind. They track incidence and prevalence. They enable program budgeting, planning and refinement. They provide insight about the quality of care by geography. They’re part of the Chronic Care Model, and that’s good, right? They also enable the follow-up of individuals. The reason why other registries have a single digit opt-out dropout rate is because patients are good citizens. Registries are expensive and government funding guarantees success.

Dr. Trief and Mr. Ellison rise in opposition to the motion. They note that public health registries were created to help combat communicable infectious disease, not chronic illness. They looked for studies that examined the link between A1c self-awareness and diabetes control and could only find one - and it apparently demonstrated no link existed. Another study is quoted that failed to find an association between the use of a registry and health care utilization among persons with diabetes. What’s more, other studies that gave alerts (for example, fax) to physicians for other conditions failed to show much improvement. They also feel the downside risks also cannot be discounted. The appearance of government intrusion could prompt patients to stay away from their physicians, the New York City registry could be ‘hacked’ and patients may be justified in worrying about how their data could be used against them in the future. While not so clearly stated, they indicate a registry is helpful when it is integrated with other quality enhancing initiatives – which are lacking here.

The DMCB is inclined to agree with the ‘con’ perspective, especially the patient dimensions – and not just because the 'pro' authors are from the People’s Democratic Swedish Republic of Vermont. Being a blog, however, it can’t help adding some other 'con' POVs by opining that while this is a well-meaning initiative, physicians are becoming saturated with prompts, nudges, reminders, alerts, warnings, cautions and alarms from well meaning good-doers using faxes, screen prompts, emails, calls and letters containing guidelines, lists, recommendations, contact information, disclaimers, bar graphs and HIPAA boilerplate. New York City’s foray may provoke registry-fatigue or even blow-back from the docs and what’s worse, give the government sponsored population-care a bad name – not only because stand-alone registries don’t work very well, but because they also annoy docs with false positives.

The DMCB can't tell if the NYC Department of Health understands notions of private-public partnerships, which would allow it to use this otherwise good idea to enable a number of other population-based care options. Does anyone have any insights to share?

In the meantime, the Archives invites readers to submit their own 250 word, clearly labeled “pro” or “con” abstract to their journal. If selected, you’ll be invited to author a full manuscript on the topic for peer review consideration.

Addendum to my post on quotes from the WHCC: My physician colleagues from internal medicine will enjoy a learned description from a surgeon who, during a presentation on the topic of medical devices, shared his insight about a key feature of nanotechnology: ‘it’s really really small.’ Yup.

Notes from the Avalere Conference, Part 2

More notes from the Avalere Diabetes / Broaden Your View Conference in Washington DC:

New number to remember: Just out.... diabetes mellitus cost the U.S. $172 billion in combined direct and indirect costs in 2007. Compared to 2002, that’s a greater than 30% increase.

Be of good cheer, the peoples’ business goes on: Diabetes, of all the chronic conditions, is a high-visibility opportunity for Congress to experiment with Medicare and Medicaid coverage. Starting in ’09, look for a flurry of diabetes-specific ‘cost and/or coverage and/or quality’ legislative proposals, including new types of reimbursement approaches (including ‘care coordination’), support for HIT (including electronic records and registries) and redefining the term ‘health care provider.’ Absent fundamental reform, expect a majority of this to be “demonstrations.” Depressed at the thought of even more demos? Me too and during an question and answer session I griped about that. I was reminded that demos have a good track record of helping to inform public policy and building consensus. What's more, sometimes you need a demo to prove something really works as well as its advocates think it works, "MHS being a case in point."

Patient education is necessary but not sufficient: A speaker asked 'how many of you know you should floss?’ Many hands went up in the conference room. ‘How many of you flossed this morning?’ Far fewer hands went up.

New acronym that makes you sound smart: GWAS aka ‘genome wide association studies’ are surveys of genetic variations in persons with an illness that compare those variations to persons without an illness. If the variation appears comparatively more frequently among persons with the disease, it can be used to not only predict the risk of future occurrence, it can point to an underlying cause. The disease causing genetic variations that are treated by drugs like metformin and TZDs have been identified, and other genetic variations that may ultimately be amenable to yet-to-be-developed drugs are in the chute. Thanks to GWAS, we ain’t seen nothing yet when it comes to diabetes treatment options.

In addition to ‘CER,’ see how many other acronyms and first names you recognize: Federally supported Comparative Effectiveness Research (CER) has attracted the support of AHIP, the BCBSA, MedPAC, CBO, IOM, Hillary, Barack and Gail. Everyone agrees that ‘evidence’ in health care is poorly defined and inconsistent. Think the answer is more gold standard randomized clinical trials? Too bad, because they are unaffordable, too time-consuming and utterly unrealistic. Let the games begin.

Got graphs? Check out this treasure box from the CDC for your next PowerPoint presentation

Do the math: Wal-Mart has come to realize that persons with Type 2 diabetes are an important market segment. Wal-Mart offers meters n’ strips, all kinds of food, $4 medications, eye centers, and walk-in clinics. It doesn’t hurt that all those persons with diabetes need to walk past other yellow-smiley consumer goods and, while they’re at it, may also decide to use the Wal-Mart pharmacy to also purchase their higher-margin non-generics.

Once a week exenatide (Byetta shot)? You heard it here first. Speaking of the incretins, they are associated with weight loss and less hypoglycemia. One speaker predicted that formulary placement of this class of drugs may ultimately be driven not only by patient demand, but by the threat of a suit over a preventable episode of hypoglycemia.

And now for a word from a ringside seat in Massachusetts’ health reform: Adults that are a) working, b) childless and c) young have been the greatest winners in this initiative; elders, children, their parents and the poor had coverage options all along. Worshipers at the Single Payor Shrine of the Left and Supplicants of the Free Market Goddess of the Right continue to loathe this program, but contrary to headlines in the Boston Globe and editorials in the Wall Street Journal, the center is holding. Yes, the budget has been exceeded, but that’s because a surprising number of persons have signed up. The insurance premiums themselves are turning out to be on target.

Dr. Google: Think it’s just EHRs, registries and decision support? Think again, because in any given day, more people go online for health care information than see a doctor. Yet, the information is still hard to find, understand and contextualize. Healthcare entities that combine the provider and the online information in a consumer friendly format is destined to win.

After hearing about continuous glucose monitors, the Disease Management Care Blog believes their coverage should be contingent on participation in an accredited disease management program. Ditto pumps. And what if an endocrinologist is involved? DM companies should get out of their way outsource the care and pay the endocrinologist (and their CDE) a majority of the disease management fee received for that patient.

Notes from the Avalere Washington DC Diabetes Conference

Notes from the Avalere Dabetes / Broaden Your View Conference in Washington DC:

Newt Gingrich, former Speaker of the US House of Representatives and shy-not commentator on the failings of medical care: served as the dinner speaker and revealed that he and a colleague from Congress have penned a soon-to-appear editorial recommending the creation of the Office of the “National Diabetes Coordinator.” Big problems warrant big solutions. He also had countless and worn anecdotes that contrasted the “world that works” vs. the “world that doesn’t work” but a fav of the DMCB was the observation that during the time a UPS driver makes a delivery to an average physician’s office, the computing power in that office is temporarily doubled.

Dan Mendelson, President Avalere Health: Republicans, Democrats and policy makers have merged into a perfect storm on the need for 1) coverage expansion, 2) cost containment, 3) quality improvement and 4) health information technology. This will probably kick off the national dialog on diabetes and chronic illness care in January 2009. Nationally sanctioned “comparative effectiveness research” (CER) is being supported by a counter-intuitive coalition of policy makers and managed care organizations: they believe it will help rationalize coverage decisions. Device manufacturers and pharma are opposed because CER can be used to deny coverage for worthwhile or innovative treatments.

Other insights from other speakers:

The ABCs: Access to a healthcare service = adequate payment. Payment in turn depends on coverage, which in turn depends on demonstrable and meaningful increases in quality. This is best demonstrated in randomized controlled clinical trails (RCTs). “RCTs don’t necessarily need to be published, you just need to know the results.” A national office for “comparative effectiveness research” will help.

Woeful physicians: Much of diabetes care for physicians is an intellectual pursuit, not a money maker. Office surveys have shown that endocrinologists consistently underbill for their services, using the Level 4 E&M code an average 53% of the time, versus oncologists using Level 5 E&M 51% of the time. Billing for group visits, diabetes self management training and continuous glucose monitoring may improve patient care and endocrinologists’ cash flow.

Medicare Coverage of medical devices is more complicated than you thought: Absent a “National Coverage Decision” (NCD) from the Medicare program, “Local Coverage Decisions” (LCDs) are used regionally at a State level to adjudicate coverage of medical devices. LCDs can be determined by evaluation (literature reviews), regulatory considerations (which may hamper a LCD) and collaboration (new device manufacturers are encouraged to enter the LCD process as early as possible).

Are we worrying about the right things? Glycemic control does not substantially increase life span in older Type 1 diabetes and does not prevent the slow progression of cardiovascular disease in Type 2 diabetes. Only 33% of vision loss in Type 2 diabetes is due to diabetic retinopathy and 90% of the retinopathy that does occur can be successfully treated despite a high A1c level. Only 10% of persons with type 2 diabetes develop kidney complications and blood pressure control is more important than the A1c.

The Disease Management Care Blog also heard about insulin pumps. It wonders if coverage of pumps should contingent on participation in an accredited disease management program.