My piece yesterday on the apparent inability of DSM to prove its value got some very pointed feedback. Gordon Norman, the V.P of Disease Management at PacifiCare, wrote this response. He suggests that there are real world answers to the question of "does DSM save money?", and that the whole health care industry needs to become more sophisticated, focus more on where DSM can make cost-effective change, and be realistic about where DSM can and cannot make a difference. It’s an excellent piece:

In response to your musings this morning on DM outcomes and "what’s really going on", I offer this counterpoint on the four recent media pieces about Disease Management that may be viewed by some, including yourself, as casting doubt on the ability of DM to generate cost savings.

Full disclosure: I am a family physician, with a decade of experience working in managed care, responsible for the DM programs that my company has deployed for our 2M commercial and 1.5M senior HMO members since 2000, which in aggregate are generating net savings of $120M measured by robust methods and validated by external third parties. Based on these results and our enthusiasm that DM is one of the few effective, feasible, and politically acceptable means available to the health care non-system to deal with escalating costs in the near term, I am now dedicated to implementing and improving these DM outcomes for both managed care and non-managed care consumers (i.e., Medicare FFS beneficiaries).

1. CBO Report on DM

On October 13, the Congressional Budget Office released a report requested by Senator Don Nickles during the MMA legislative process that appears critical of DM’s cost savings potential for Medicare. This report represents no new knowledge about DM — CBO simply reviewed the available peer-reviewed literature and concluded that the evidence supporting financial savings from DM was inconclusive, not that there was good evidence demonstrating that DM does not or cannot generate positive ROI. This is not surprising, given that very little DM has been conducted as randomized trials, intended for publication in peer-reviewed medical journals. Health care delivery research is much harder to conduct in the classic "double-blind, randomized control trial" design as are medical studies with investigational drugs, and the majority of DM today is motivated by business vs. research drivers. Consequently the published DM work represents only a small fraction of the accumulated DM experience, and much of what has been reported is obsolete by current DM standards. In contrast, a variety of robust, quasi-experimental designs reported at DM meetings and the non-peer reviewed literature have repeatedly demonstrated significant ROI for good DM programs. Also, even if DM is shown to reduce short term expense but turns out to increase longevity for some with chronic illnesses, it may very well increase long term expense for Medicare relative to no DM — while increasing lifespan may be worthwhile in itself, from a Medicare Trust Fund solvency point of view, it will be a concern for those who must figure out how to fund that longevity.

In contrast to the CBO conclusion (or rather "inconclusion"), many prudent purchasers of health benefits, and the plans who supply these services, are convinced by the preponderance of evidence that short term economic benefits exist for DM, even if uncertain about the best method for calculating. The current $800M – $1B of annual spend on DM services carries a substantial amount of credibility about perceived savings in the marketplace. Understandably, CBO and policymakers may require a standard of proof that is "beyond a reasonable doubt" as opposed to a "preponderance of evidence" standard — that will require multiple, large scale, randomized controlled trials; fortunately, CMS’s ongoing BIPA and CCIP demos will provide just that. Here’s a link to the transcript of the DMAA’s rebuttal to the CBO.

2. CHF DM results in Annals Int Med

The October 19 issue of Annals of Internal Medicine published an article from Stanford/Kaiser about CHF DM. Dr. Robert DeBusk working with Kaiser centers in No Ca performed telephonic DM for wide range of CHF patients in RCT (Tx N=228), and found no statistically different outcomes for rehospitalization, ER visits, or death. (DeBusk developed MULTIFIT program, which was licensed by both CorSolutions and Kaiser for their CV DM programs.) They claim this is largest randomized study to date to evaluate specialized care mgt for patients discharged after hosp. for CHF. Notably, only 49% of these patients were of the same severity as those we enroll in our CHF DM (NYHA Class III or IV) at baseline, as indicated in the title of the article, "Care Management for Low-Risk Patients w/ Heart Failure". This is obviously one speculative reason why no difference in outcomes was achieved, but also perhaps also because Kaiser providers and patients are already "more EBM compliant" at baseline than non-Kaiser physicians, leaving little headroom for DM improvement. Also, the telephonic CHF DM approach used here may not be suitable for optimizing savings in low or high risk populations.

3. UT study on CHF DM at AHA Annual Meeting, Circulation

A report from the annual AHA meeting describes a large academic research project, "Long-term Impact of Disease Management in a Large, Diverse Heart Failure Population", at University of Texas, San Antonio which will appear in Dec 7 issue of Circulation. Over 1,000 elderly patients were assigned to telephonic case management by CorSolutions. Despite some minor longevity gains, there apparently were no utilization or cost differences in the treatment and control groups. From review of the article, I believe this study targeted too broad a cohort to optimize savings, and used suboptimal (telephonic only) interventions.

4. Kaiser DM in Health Affairs

This week Kaiser researchers published a longitudinal assessment of quality, utilization, and costs for adults w/ four major chronic conditions for the period 1996-2002. By their own report, Kaiser’s form of "DM" is an amalgam of many activities such as clinical guidelines, patient education, disease registries, proactive outreach, reminder messages, multidisciplinary teams, and performance profiling for providers, most of which are embedded in the usual delivery of primary care within the Kaiser system; in some cases, care managers are also utilized for DM. No defined "pre/post" periods can be defined for most of these efforts, as they were adopted incrementally. The authors concluded that quality measures showed improvements, but no reductions in real costs were demonstrated over this time frame for any diseased cohort. However, it appears that similar cohorts of patients without these conditions experienced signficantly greater cost increases over this period, suggesting relative trend mitigation.

Associated editorials by Kaiser clinical executives suggest that the authors set an impossible hurdle in trying to demonstrate absolute cost reductions year over year, even though the relative cost savings of these programs was over $200 million. They point out the challenges of determining DM impacts caused by (1) varying definitions of cost savings; (2) identification and characterization of baseline experience; and (3) issues about allocation and timing of costs and savings. We would agree that looking simply at total cost over time invites many confounders that may obscure true DM impacts — changes in unit costs, changes in networks, changes in covered benefits, changes in EBM/technology, severity changes in populations, etc. That is why we support DM savings methodologies that target the most important drivers of chronic disease cost and adjust for anticipated confounders (e.g., unit cost adjusted, CHF disease-related costs for identically-defined pre/post CHF cohorts), and then compare these financial outcomes with non-financial event outcomes (e.g., hospital & ER admissions) to test the plausibility and credibility of the economic results — an approach that has achieved recognition by the Disease Management Purchasing Consortium in their awarding PacifiCare certification of our outcomes methods for DM programs.

Takeaways from these 4 articles:

• DM is getting more public exposure — while it may be glib to suggest "there’s no such thing as bad publicity" for DM — as for celebrities — greater public scrutiny of DM to separate the hype from the reality, and the performers from the wannabe’s, is overdue and welcome.
• All DM is not alike — it is predictable that telephonic DM interventions may not have the same impact as remote monitoring interventions, or that targeting high risk populations will save more money than targeting all risk groups indiscrimately. Caution is urged in generalizing the conclusions from any one "DM study" to other DM settings or interventions. DM is not automatically good — there is good DM and not so good DM, and the differences require some digging beneath the surface.
• DM won’t save short term costs for people who weren’t going to have any — low severity CHF patients aren’t sufficiently at risk for utilization for even good DM to be effective, much less pure telephonic.
• Academics have a different standard of proof than business for DM outcomes — as evidenced by DM revenue growth CAGR of 20-30%, business appears to have sufficient proof of DM value today with their "preponderance of evidence" standard, while peer-reviewed reports of well-designed RCTs are still accumulating for policymakers, who maintain a "beyond a reasonable doubt" threshold.
• DM outcomes methods are in evolution, and therefore reported DM outcomes are not easily compared — DMAA is leading an industry-wide movement for increasing standardization and rigor in these methods and reported results. Their white paper was released at the annual DMAA meeting 2 weeks ago, and will serve as a template for improved methodological approaches in the future. (Not available on line but email Matthew if you want a copy)
• We must get beyond "Does DM work?" to "Which DM models work best for which patients on which measures?" — (after all, does "health care" work? It depends on who/what you measure.) Determining whether provider-based chronic care models, one-stop call center DMOs, or specialty DM vendor results are superior from identically defined metrics for equivalently defined populations is where we should headed. "Negative results" from studies utilizing any one DM approach tell us nothing about DM in general, only about one implementation of DM.
• Don’t expect DM to eliminate trend — absolute health care costs are going to rise for many reasons beyond the avoidable "wasted" dollars spent for chronic disease populations; DM should not be discredited for not mitigating all the trend drivers. We musn’t let Perfect be the enemy of Good — for DM to impact a large percentage of the avoidable costs for chronic disease patients while improving their quality of life, clinical and functional status, and in some cases, even their longevity, is a Very Good performance indeed.
• Who has a better idea? — while it may not yet have been incontrovertably demonstrated that good DM consistently produces favorable short-term economic outcomes, there is a body of evidence supporting that hyporthesis, and a larger body of work supporting many non-economic benefits from DM. So what other ideas are on the policy table that will work better, faster, or cheaper to address the growing mismatch of a health care system designed for high-tech, specialty acute care with an aging constituency with escalating chronic care needs? Universal coverage? Consumer-directed healthcare? Widespread EMR w/ point-of-care decision support? All of these are politically elusive, undeniably expensive, unfeasible for short term implementation, and unproven with regard to net health care cost savings.

The Wall Street Journal (from which this is stolen in its entirety as most of you can’t get to it) basically advocates Pfizer’s claim that their DSM process in Florida works and saves money; $41.9 Million to be exact:

Pfizer Inc.’s health-management program in Florida cut the state’s medical costs by $41.9 million in the 27 months ended in September 2003, Pfizer said Tuesday. Pfizer, the world’s largest drug maker, in 2001 launched the joint initiative, which provides patient education and nursing care to patients with chronic diseases such as diabetes who are covered by Medicaid, the federal and state health-insurance program for the poor.The goal was for Pfizer to save Florida $37.5 million for the life of the program’s four-year contract, which ends in September next year, Pfizer spokesman Jack Cox said.

During the 27-month period, Pfizer also has given the state about $19.2 million worth of other investments and its medicines, Pfizer said. The results of the program so far validate "the original approach we took with respect to the state’s budget problems," Henry McKinnell, chairman and chief executive at Pfizer, said in an interview with The Wall Street Journal.

He said Pfizer is in discussions with other states about applying the same approach. But Florida has been alone so far in pursuing the Pfizer model. The results were determined by Medical Scientists Inc., an independent organization.Mr. McKinnell praised Gov. Jeb Bush’s willingness to try the approach despite opposition in some quarters in Florida. Meanwhile, Pfizer is talking with several employer groups about applying similar principles and is looking for partners overseas for analogous projects in Germany, Italy and Sweden.Under the current contract, Pfizer is exempt from paying heavier rebates on drugs for Medicaid patients in Florida, in exchange for offering its disease-management services.

However, earlier this year, the Florida Legislature put a stop to new contracts like this that offer value-added programs in lieu of supplemental rebates. Pfizer’s program remains in force through September 2005, and the company said it would use the positive results in an effort to persuade lawmakers to reconsider allowing such plans beyond then. Pfizer said that the program has reached nearly 150,000 Medicaid beneficiaries in Florida.

But the State of Florida is by no means as happy as Pfizer thinks it should be, or as the WSJ’s cheerleading suggests it is. Why not?

The disconnect between Medicaid, Florida lawmakers, and Pfizer hinges on a scathing report put out by the Office of Program Policy Analysis and Government accountability several months ago. In a roundhouse blow to Medicaid DM in general, the OPPAGA said that the Legislature’s big hopes for disease management never panned out; big savings weren’t being realized, the numbers that were reported were suspect at best, agency oversight was weak, and many of the recipients that were supposed to be in the program weren’t. In fact, only about a quarter of the chronically ill patients ever made it into DM. Their penetration of disease categories were only 19% for Asthma, 29% for Diabetes, 17% for CHF and 22% for Hypertension. (though they were at 69% for HIV)

Based on OPPAGA methodology, DM did pay back $1.46 in savings for every $1 spent. LifeMasters, for example, was credited with saving slightly more than $5 million for its CHF program, comparing the $7.63 million in program costs with $12.66 million in gross savings. Pfizer produced $900,000 in net savings in a program that cost $7.5 million. And in a field where there are no "perfect methodologies," OPPAGA said that Pfizer’s calculations for determining gross savings were fundamentally flawed, seriously inflating its earliest returns. Just don’t tell that to Pfizer, which fires back that OPPAGA is the one that’s guilty of fuzzy math."The report is not accurate," counters Cox. "It had several glaring errors in it. They didn’t even recognize that Pfizer was paying for the program."

But perhaps even more convincing for state legislators, OPPAGA had already rendered a negative verdict on the kind of value-added program that Pfizer championed. Not only were drug companies avoiding discounts or supplemental cash rebates if they offered value-added programs, the state agency maintained, so were their competitors. Any drug company with a competing product didn’t have to discount its price significantly to get a drug on the preferred drug list if Pfizer and the others weren’t discounting at all.

In fact the state believes that it gave up closer to $60m in rebates and discounts to get those $40m in savings. In other words, DSM works but not well enough. That has a nasty implication for drug companies trying to use DSM as a wedge into preferred positions on formularies. Payers may believe that they are better off just getting the maximum discount possible from the pharma company (which its competitors then have to match) and paying for the DSM themselves, rather than giving the pharma company a better deal and hoping that they’ll save more in payback from a the DSM process that the pharma funds. This should be pretty good news on the face of it for the independent DSM vendors like Lifemasters and American Healthways, but then again there are three sides to every story.

The third side has been causing a fuss in the DSM community this week. A couple of different studies have not such good news for the whole DSM community. One from Texas is about CHF patients using ACE inhibitors, and another is about the results of Kaiser Permanente’s DSM programs since 1996.

The

first study from Univ. Texas researchers showed that a DSM program for a chronically ill populations with CHF and diabetes didn’t save any money. Smartmoney reports that:

After 18 months, the disease management group lived an average of 76 days longer than those in the control group. But the study showed no difference in doctor visits, hospitalizations and prescription drug costs.

"Unfortunately, it did not save any money at all," said Dr. Autumn Dawn Galbreath, the study’s lead author. She noted that some states such as Florida have set up disease management programs and then cut their Medicaid programs in anticipation of savings. She said previous studies of disease management programs were smaller. She also said they preceded newer treatment guidelines, which appear to be more effective in managing heart disease. For example, heart patients are now routinely put on blood-pressure lowering medications known as ACE inhibitors. Fewer than half of patients in previous disease management studies were on ACE inhibitors, while 77% of patients in the Texas study were on them, researchers said.

Meanwhile the Kaiser study in Health Affairs (abstract here, full paper here) comes straight out and says that costs for the group in the DSM programs increased, as did quality indicators. Some extracts from the Kaiser study:

Costs rose for each of the four conditions during the study period. After adjustment for age, sex, and inflation, annual costs for CAD patients, for example, rose $2,110, or 19 percent. Among adults without the conditions, costs increased by fewer real dollars yet by greater or equal percentages. For patients with and without the four conditions, costs rose in each of the five categories (data not shown). The only exception was hospital costs among diabetes patients, which stayed the same. Increases were steepest for pharmacy costs and least for hospital costs.

Hospital admissions increased less on a percentage basis in the chronic disease populations than in their comparison populations, and, with the exception of heart failure, so did hospital days. Diabetes and asthma patients had fewer hospitalizations in 2002 than in 1996, even as hospital days stayed about the same. Heart failure and CAD patients had more hospital days in 2002 than in 1996…..ER visits decreased by a greater percentage for asthma patients than for their comparison group.

A commentary from some senior staff at Permanente suggested that even though costs went up for the DSM group, there were savings over what the costs for the groups in the absence of the DSM program would have been. Of course there wasn’t a control group for Kaiser like there was in the Texas case. However, most quality measures or process measure outcomes such as levels of LDL, etc, were overwhelmingly positive. And the commentary also pointed out that Kaiser patients were relatively well managed (and had relatively little money spent on them) in advance of the program’s creation. So it appears that finding cost savings is very hard–especially if you’re not screwing up in the first place–while improving care quality is somewhat easier.

Of course, the members of the online DM Forum had various opinions, ranging from Al Lewis saying that

you could surf in Tahiti even if the "old school" said you couldn’t (i.e. he didn’t believe the Texas study) to those (Vince Kuratis) who said that the problem was either the patients were already too well managed — already 77% of them were on their ACE inhibitors — or (Mary Wieg) that they weren’t sick enough on average and that DSM should concentrate on the sickest ones. Still others (Margaret Radzwill) suggested that the actual DM process itself was flawed because there were fewer patients on ACE inhibitors at the end of the study than the start. And occasional TCHB contributor Dave Moskowitz put out a press release saying that the ACE inhibitors being used were the wrong ones in the wrong dose! (There’s alot more comments at the Forum and if you’re interested in this topic you should sign up).

There’s a lot to chew on here, but the obvious conclusion is that while DSM is good for patients, it’s hard to get some patients into it and once you get past the really low hanging fruit, it may not be that good for the bank balances of the sponsoring plan/payer. That plans have been reluctant to do DSM is no new news. Don’t forget that most Americans will move from their health plan in less than two years. So the incentive to put these programs out there remains cloudy for most private plans because even if they do pay back, the money will be saved by the next plan, not them. So we shouldn’t be surprised that DSM is not storming the world.

But it’s a bit of a shock to find that DSM might potentially hurt the bottom line of a plan like Kaiser that tends to keep its patients around. (Although the Kaiser top brass apparently don’t think that it is hurting them, other health plan execs might not be so sanguine). As Medicare is starting to lumber towards DSM this is going to be a big discussion issue, and it would be very nice to know what’s really going on.

UPDATE: Mary Weig, who I referenced as saying that the patients in the Texas study weren’t

sick enough on average and that DSM should concentrate on the sickest ones, writes in accusing me of being a Fox News employee:

The way you quoted me was a bit misleading. My point was that DM programs should concentrate on people who are not complying with optimum treatment plans–as well as the sickest ones. If they don’t comply with optimum treatment plans, they will end up sicker eventually. That’s why stratification and focus are so important.

This piece has generated quite a bit of feedback (some of it quite complimentary), and at least one excellent detailed response. So please check back for more on DSM tommorow. (And no, of course Mary never said I should work for Fox, but if they’re hiring….)

The NEJM has an article about the IOM patient safety report five years on. It’s by by a pretty elite group; Drew Altman of Kaiser Family Foundation, Carolyn Clancy, head of AHQR, and Bob Blendon at Harvard. Basically they are over kind to the system, suggesting that a move from 4% to 7% of hospitals putting in CPOE is a big deal, when it’s not really. I hope to have Michael Millenson, who is not so kind to the system commenting on this in the near future in TCHB. Anyway, the authors also note that the public perception of health care providers’ safety has been considerably reduced:

Unfortunately, despite five years of focused attention, people do not seem to feel safer. More than half (55 percent) of the respondents in our survey said that they are currently dissatisfied with the quality of health care in this country — as compared with 44 percent four years ago.5 In fact, 40 percent believe that the quality of health care has “gotten worse” in the past five years, whereas only 17 percent think it is better. And half are worried about the safety of their medical care.

Altman, Clancy and Blendon think that we’ll likely solve the patient safety issue as there’s bi-partisan agreement on the need to solve it and the info-tech needed to solve it is becoming more widely used. But they also stumble upon the key issue which is that:

Physicians also strongly oppose public reporting of information on medical errors — perhaps because of worries about malpractice lawsuits, which physicians name as the top concern facing health care and medicine today. In stark contrast, 71 percent of the public believes that public reporting of medical errors by government agencies would be very effective in reducing errors, and 7 in 10 persons say that such reports would tell them “a lot” about the quality of a hospital or a health plan.

Well they’re a lot more optimistic than I am. In over a century of conflicts between what’s good for doctors and what’s good for the public, only one side has ever won. Some leadership from the AMA on this issue would be nice, but I guess they’re busy pissing off the trial lawyers. And the importance placed on that conflict is most of the problem, and it’s one that I fear that the reasonable authors of this article understate.

I spent a day last week at IFTF’s meeting on Personal Health Ecologies. These are my notes, so use these as provocation material rather than a finished argument. But something important is slowly going on here, and health care wonks and industry players should be aware.

As you know I have some affection and connection for IFTF. Their research lately has veered away from the health care system per se and is looking more at health as a lens for commerce–that is looking at the potential businesses to support consumers living their lives with a health focus. They call these personal health ecologies–more about them on page 10 of this report. The crowd at the meeting was not just the traditional health plans/pharma/services types but also financial services companies, software companies, hardware, consumer goods vendors and anyone else looking to learn more about consumers.

One major part of the research this year is looking at the behaviors of the chronically ill. Businesses are getting interested in figuring out these groups as there will be more and more of them in the future. Today’s meeting looks at the chronically ill, and how they manage their own health ecology. This doesn’t just mean their interactions with the “health care system” (plans, doctors, hospitals) but also with their relationships (family and friends), their connection with products, with technology and where they care for their health. To do this IFTF did a whole bunch of ethnographic research, following people around at home, at work and in their daily lives just managing their disease. This is all pretty intangible stuff for a business, but it’s basic research that is important for developing products and services.

So what are they looking at? Diabetes, obesity….

Rod had a “fun” scenario looking at obesity. Interestingly as Generation Y gets fatter, their rate of health spending will increase much faster (maybe in their 30s as opposed to in their late 40s). What might be evidence of this scenario? The key question is at what point will obesity and physical inactivity overtake smoking as the leading cause of preventable death. As obesity and diabetes increases there’s much more focus on obesity and prevention amongst men and children, rather than just Weight watchers as a place for women concerned about looking good.

In terms of business opportunities, there’s a lot of invisible work in tracking and managing disease–so there’s a huge opportunity for routinizing their information management and automatic data capture at home–same as in the hospital (80% of nurses work is recording data and that’s slowly being captured and recorded automatically). Also having to interpret the results of the data, which are not intuitive to the patients.

There’s a real problem for chronically ill people. They get on and off their regimens because they can’t stay there. We need something to make the treatment less miserable than the disease.

So what were the companies at the conference doing to help the chronically ill? Three examples at the meeting:

• Intel is trying to wire the home. They realize that health doesn’t live on the desktop, so how does Intel get into it? They have test houses out with RFID sensors everywhere and devices networked together, and even biometric devices that can be in the bloodstream. They’re also trying to develop mote-based sensors.
• Abbott, in its diabetes division has a wireless sensor implanted into the skin sending continuous a wireless data stream to a glucose meter on the belt, called the Freestyle Navigator.
• Health Hero has a new version of the Health Buddy out which is now both text and voice operated, and can be connected to devices like digital scales.

In many ways the potential success of this is linked to pay-for-performance or more likely some form of pay for outcomes. This is (maybe) going to drive the adoption of disease management techniques in Medcare populations, and may move some of the techniques Health Hero and others are using into the mainstream of health care delivery. We’ll see, but it’s a long transition from where we are now.

Meanwhile, the conference moved onto a riveting session about wider issues of how to change the wider patterns that cause obesity and diabetes, and made me feel very fat! What might stop this trend? Stanford Prof Christopher Gardner tells us that its the Mediterranean plant-based diet rather than the typical American diet….but how to make people change? (Here’s more on his techniques). At the moment we focus on people changing but in fact you can change the way people eat by packaging–but that’s been used so far to make people eat more. Chris recommends “Food Politics” and “Fast Food Nation” as great books that have far more impact than any moralizing professor suggesting a diet. But Susan Foerster from the California “5 a day” campaign (State of California Health dept) shows that financially there is no way to marketing-wise fight the fast-food monolith. Something like $50bn is spent on food advertising (none on veggies) versus under $400m of PSAs. The result = obesity. (Did you know there were 66 spoonfuls of sugar in a 7-11 Super Big Gulp?) And this runs to other political decisions — $72 per capita spent on roads compared to 0.55c spent on pedestrian walkways. Also limited access to fresh produce in poorer areas.

This is all depressing stuff. My view is that the cost of obesity is massive but the marketing is all pushing this one way–to more obesity and more chronic disease. The only way to break this is to divide the corporations who are paying for the costs of obesity from the food companies who are making money from it. But that’s a long way away from our current medical culture. So my bet is on more obesity and more diabetes. Interesting stuff.