The Definition of "Disease Management" (with other definitions)

Thanks to prior postings in the Disease Management Care Blog, readers have had access to handy and literature-based definitions of "patient centered care," "care management" and "value based insurance design." Not only can regular readers quote them with confidence, insert them in company-wide memos, amaze colleagues with deep subject matter expertise, bore the DMCB spouse and use them against know-it-all consultants, the definitions make for perfect verbal swordsmanship at that next staff meeting. For example:

"Er, exsqueeze me Bob, but everyone at this meeting except you knows that care management should also be postured to reduce the duplication of medical services!"

Then it occurred to the DMCB that it had not blogged about the definition of disease management. Now that is an embarrassing lapse. The term may have lost much of its brand luster among the vendors and is no longer de rigueur among the policymaker elites, but the contrarian DMCB still predicts the catch-phrase will eventually make a comeback. In happy anticipation of its eventual resurrection, the DMCB proposes this formal definition:

A package of mutually supportive interventions to improve quality or mitigate the insurance risk of a population defined by the presence of a chronic condition.

This short and efficient definition is good because 1) it emphasizes disease management's multi-dimensional nature, resulting in a synergy that is greater than the sum of its parts, 2) it recognizes that in addition to quality, there is merit to controlling costs and doing so in the context of health insurance; in other words disease management and managed care are inextricably intertwined and 3) it transcends one-on-one care, akin to "applied" health services research that also studies defined cohorts. One other feature that favors this definition as eminently quotable is that it has also been published in the peer-reviewed literature (1).

The DMCB also looked up the old and more lengthy DMAA definition of disease management. For the sake of completion, it's reproduced below. Fortunately, it's also been memorialized in the medical literature (2) for your quoting pleasure:

"A system of coordinated healthcare interventions and communications for populations with conditions in which patient self-care efforts are significant:

• Supports the physician or practitioner/patient relationship and plan of care,

• Emphasizes prevention of exacerbations and complications utilizing evidence-based practice guidelines and patient empowerment strategies, and

• Evaluates clinical, humanistic, and economic outcomes on an ongoing basis with the goal of improving overall health.

Disease management components include:

• Population identification processes

• Evidence-based practice guidelines

• Collaborative practice models to include physician and support-service providers

• Patient self-management education (may include primary prevention, behavior modification programs, and compliance/surveillance)

• Process and outcomes measurement, evaluation, and management

• Routine reporting/feedback loop (may include communication with patient, physician, health plan and ancillary providers, and practice profiling)

'Full-service disease management programs' must include all 6 of the above components. Programs consisting of fewer components are 'disease management support services.'"

Other definitions have been proposed. There is a list here and a table with other definitions was published here, courtesy of the American Heart Association (2).

As a further service to it's readers, the DMCB has reproduced the definitions of "patient centered care," "care management" and "value based insurance design" below along with the necessary citations. In addition, there is a paraphrased definition of "population health improvement," which has been put forward courtesy of the Care Continuum Alliance (CCA).

Patient centered care any care that is "respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions" (3).

Care management is a set of activities designed to assist patients and their support systems in managing medical conditions and related psychosocial problems more effectively, with the aims of improving patients’ functional health status, enhancing the coordination of care, eliminating the duplication of services, and reducing the need for expensive medical services (4).

Value based insurance designs are health insurance designs that reduce patient out-of-pocket expenses for covered services that provide important medical benefit relative to costs (5).

Population health improvement is paraphrased by the DMCB as a package of services that identifies a population, conducts a needs assessment of that population, provides health promotion programs that increase awareness of the health risks associated with certain personal behaviors and lifestyles, promotes health management goals and education as well as self-management interventions aimed at achieving behavioral changes. routine reporting and feedback loops which may include communications with patient, physicians, health plan and ancillary providers with ongoing evaluation of clinical, humanistic, and economic outcomes. the full definition can be found here.

References:

1. Sidorov J, Schlosberg C: Disease management and the Medicare modernisation act: "It's the insurance, stupid." Disease Management December 2005;8(6): 331-338

2. Krumholz HM, Currie PM, Riegel B et al: A taxonomy for disease management. Circulation 2006;114:1432-1445

3. Epstein RM, Fiscella K, Lesser CS, Stange KC: Why the nation needs a policy push on patient centered health care. Health Affairs 2010;29(8):1489-1495

4. Bodenheimer T, Berry-Millett RL Follow the money - controlling expenditures by improving care for patients needing costly services. New Engl J Med 2009;1521-1523

5. Chernew ME, Juster IA, Shah M, Wegh A, Rosenberg S, Rosen AB, Sokol MC, Yu-Isenberg K, Fendrick AM: Evidence that value-based insurance can be effective. Health Affairs 29(3):530-536

Another Wellness Program Demonstrates Value

On the heels of this Health Affairs publication on the economic value of employer sponsored wellness, we now have this "on-line" report from Population Health Management. You know it's going to be an interesting when it simultaneously involves a care management company (HealthMedia), an academic institution (University of Michigan) and a health insurer (a subsidiary of a Blue Cross Blue Shield Plan).

The manuscript is titled " The Economic Value of a Wellness and Disease Prevention Program" and was authored by Steven Schwartz, Caryn Ireland, Victor Strecher, Darren Nakao, Chun Wang and Deborah Juarez. It makes for interesting, if difficult, reading.

The Disease Management Care Blog will try to summarize.

The authors evaluated the Hawaii Medical Service Association's "HealthPass" program. This includes a health risk assessment (HRA), biometrics (like the usual lab tests, blood pressure measurements, assessments of body mass index plus the age/gender recommended screenings), counseling (which could be one-on-one, group or telephonic) and access to online awareness, education and motivational wellness support interventions with or without financial incentives. In other words, it was state-of-the-art.

In order for HMSA enrollees to be included in the study, they had to be between 18-70 years old, a member for at least 9 months between 2002-2005, not exceed $100,000 in claims per year, not have been in a nursing home and not have remained in a hospital for a prolonged period of time. Of the approximate 384,000 HMSA members, 166,201 (43%) met the criteria described above. Of this group, a total of 11,883 participated in HealthPass at some point (it looks like 11,498 in 2002, 5192 in 2003, 4247 in 2004 and 4060 in 2005, suggesting some individuals participated over multiple years). Age, gender, baseline morbidity and baseline costs were used in "propensity matching" to fashion a one-for-one non-HealthPlass comparator control group for each of the four study years.

Compared to the control group, HealthPass participants consistently had lower total average health care expenditures. What's more, those savings exceeded the yearly HealthPass costs (which ranged between $204 and $236 per year). The net savings was $34 per participant in 2003, $132 in 2004 and $124 in 2005. The calculated total "return on investment"was $1.58 in reduced claims expense for very dollar spent.

In addition, there appeared to be a "dose response" curve: more years of participation led to even greater savings. What's more, persons with higher levels of morbidity appeared to achieve greater savings. Finally, the savings appeared to hold up if two year cost trending was used to project future costs.

When the DMCB was reading this, it found it hard to understand which year's savings was being compared to which year's costs. With that caveat, it thinks this study is part of an expanding body of evidence that supports multi-component worksite wellness programs. The authors also deserve credit for correctly pointing out that there may been been ethnic, educational, psychological, attitudinal, behavioral or other unmeasured factors that were not captured by the propensity matching that could have accounted for the observed differences.

Last but not least, two of the University of Michigan authors (Drs. Schwartz and Strecher) are also affiliated with the HealthMedia care management program. Bravo, says the DMCB. It wishes more if its academic colleagues would get into fashioning and evaluating "real world" programs that are not only doing measurable good but are commercially viable. As an added bonus, you check out this video here of Dr. Strecher explaining his passion for web-based health behavior change. Watch it over lunch with your salad, tofu, yogurt or donuts. You won't be disappointed.

Image from Wikipedia

Population Health Management Journal Summarized Again!

It took a while and it needed some much needed breathing space, but the Disease Management Care Blog finally stopped looking guiltily at its unread October issue of the Population Health Management Journal and finally cracked the cover. It knows it's not the only one battling a very busy time of year and that there are holidays to contend with. So, here comes the DMCB to our mutual rescue with this handy narrative summary of each of the PHM articles. Now you can efficiently catch up, find some pearls to quote or decide to take a closer look at an article (your own copy can be found here) that captures your interest.

Dan Kent, Linda Haas, David Randal, Elizabeth Lin, Carolyn Thorpe, Suzanne Boren, Jan Fisher, Joan Heins, Patrick Lustman, Joe Nelson, Laurie Ruggiero, Tim Wysocki, Karen Fitzner, Dawn Sherr and Annette Lenzi Martin: Healthy coping: Issues and implications in diabetes education and care.

What happens when you put some CDEs, PhDs, RDs and one MD in a room and ask them about “coping skills” among persons with diabetes? This article is what happens, which has everything you’d want to know about the topic and more. The DMCB learned that “coping” is among the seven diabetes self-care skills (in addition to healthy eating, being active, monitoring, medications, problem solving and reducing risks) that has been identified by the American Association of Diabetes Educators (AADE). It can be defined as “responding to a psychological and physical challenge by recruiting available resources to increase the probability of favorable outcomes.” It’s difficult to measure, highly dependent on psychosocial factors, vulnerable to depression and should be routinely assessed in the course of patient counseling. The DMCB thinks this is a good article that give readers a different way to think about the coaching that they already know about.

Kavita Nair, Kerri Miller, Jinhee Park, Richard R. Allen, Joseph J. Saseen and Vinita Biddle: Prescription co-pay reduction program for diabetic employees.

The DMCB always thought that small swings in pharmacy insurance co-pays for medications would translate into big differences in medication compliance. So, when an unidentified “state employer” moved all its diabetic medications to the lowest tier ($10 to $20) co-pay it would have thought that the 589 continuously enrolled persons in this study would have had more than just a 3% increase in medication adherence (defined as filling 80% of chronic prescriptions) in the following year. There were decreases in emergency room and hospitalizations among the 589 persons who were continuously enrolled during the study period. Unfortunately, this was a "pre-post" study and authors are correct when they note that it's difficult to ascribe any of the measured changes to the decreases in the co-pay. The DMCB notes that it really can’t conclude anything after reading this article.

Safiya Abouzaid, Eric Jutkowitz, Kathy Foley, Laura Pizzi, Edward Kim and Jay Bates: Economic impact of prior authorization policies for atypical antipsychotics in the treatment of schizophrenia.

What happens when a research grant from a pharmaceutical company pays for a study that uses a “decision analytic model” to assess the impact of something disliked by pharma: insurer-based medication prior authorization (PA)? The DMCB figures chances are that it’ll show it doesn’t work. While this study showed “only modest savings approximately half the time,” the DMCB lives in the real world and doesn't trust this brew of model inputs, software, assumptions and sensitivity analyses.

James Springrose, Felix Friedman, Stephen Gumnit and Eric Schmidt: Engaging physician in risk factor reduction.

In this study, the authors got three primary care practices with 17 providers to agree to participate in a pay for performance (P4P) and referral program involving 546 patients who, on the basis of a claims analysis, appeared to have coronary artery disease, diabetes or high blood pressure. These were patients with two years of established care who were re-evaluated over the 6 months after the program started. Each "biomarker" improvement in weight, lipid levels, diabetic control or blood pressure control resulted in a $65 payment. Providers were also encouraged to refer patients to a disease management program. Compared to the baseline period, when there were 9 spontaneous biomarker improvements, the 6 month period had 96 pay-outs. Of 187 patients who appeared to be candidates for referral into disease management, 80 were actually referred by the providers and 43 agreed to participate. The DMCB thinks this is an interesting pilot study and the notion that P4P could promote buy-in for referring to disease management to be interesting. More research using a concurrent comparator would be a good next step.

Alex Harris, Katharine Bradley, Thomas Bowe, Patricia Henderson, Rudolf Moos: Associations between AUDIT-C and mortality vary by age and sex.

Screening for alcoholism identifies persons who are alcoholic and alcoholics have a higher rate of death, so do persons with a positive screening test have a higher rate of death? In this instance, from 2004-2005, approximately 225,000 Veterans Administration patients were given the AUDIT-C screening tool. When the 1-12 range (the higher the score, the greater the likelihood of alcoholism) AUDIT-C score was divided into quartiles, women in the highest quartile had an increased death rate, as did men in the higher two quartiles. Male non-drinkers also appeared to have a higher death rate. The DMCB finds none of this surprising and thinks this confirms the need to aggressively screen for alcoholism in the course any care programming.

Urvashi B. Patel, Quanhong Ni, Carol Clayton, Peter Lam, Joseph Parks An attempt to improve antipsychotic medication adherence by feedback of medication possession ratio scores to prescribers.

Missouri instituted a “Treatment Adherence Program (TAP) in four community mental health centers for patients that had been prescribed antipsychotic medications. When these patients failed to filled their prescriptions at 7, 30 and 45 days, an alert email was sent to a responsible provider in the clinic. 78 patients with a record of lapsed prescriptions were compared to a convenience group of 269 patients. Compared to the control group, patients in the intervention group has a small but statistically significant increase in filling their prescriptions over the 6 months surrounding the intervention. This decayed after the alerts were stopped. The DMCB thinks this was a nice try, but more will be needed to help these patients continue to take their life-saving medications than simply alerting their overworked providers.

Ronald Loeppke, Dee Edington, Sami Bég: Impact of the prevention plan on employee health risk reduction.

Three disparate employer groups used a wellness program (including a health risk assessment, blood screening tests, results review with recommendation, an action plan, live and web-based support services and ongoing feedback). 2606 employees completed the entire suite of services. 15 health risk measure categories were assessed over the course of the following year, and they were compared to the "Edington Natural Flow Model" that measures health risks in a population without access to health improvement. If you believe the model, the reduction in 10 of the risk categories achieved statistical significance that favored the intervention group. Close to half of individuals in the overall high and moderate risk categories moved to the next lower level of risk.

The Disease Management Care Blog Gets A Grooming

Thousands of regular readers of Disease Management Care Blog readers will notice that the information, links and other helpful stuff over on the right of its web page have been updated. The DMCB rearranged them into categories such as News and Policy, Journals, Bloggery, Commerical Health Insurer Coverage Policies, Guidelines 'n Standards and created a new one called Not A Waste of Time. Since its humorous videos on ACOs and the PCMH have far exceeded most of the other yawnfest YouTube postings on both topics, the DMCB decided to link them too.

Readers are always invited submit alerts about other links that may be useful to the DMCB community.

A Hippocratic Oath For Accountable Care Organizations (ACOs)

During it's post-Thanksgiving meal torpor, it occurred to the Disease Management Care Blog that it recited the Hippocratic Oath upon graduation from medical school. Since modern scientific policymaking has ascertained that goodly medicine should be a team sport, the agreeable DMCB wonders if other members of the health care community would want to demonstrate similar allegiance to the art. It is in that spirit that the DMCB offers up a version of the Oath for the newest member of the health care family: Accountable Care Organizations (ACOs):

I swear by CBO, the scorer, Hopefulius, Prayitworkius, and Panacea, and I take to witness all those who testify, publish and make presentations based on assumptions and made-up stuff, to keep according to my ability and my judgment, the following Oath and agreement:

To consider dear to me, as my parents, CMS who will regulate this art; to live in fear of its Administrator and, if necessary, to share upside risk with him or her; To look upon his or her regulations as my own siblings, to not rock the boat lest I be tossed under the bus or have to respond to a hostile letter from HHS Secretary Sebelius.

I will hustle for bundled payments for the good of my patients according to my ability and my judgment and avoid expensive MRI scans and other non-evidence based priceyness for everyone.

I will not give in to anti-trust allegations, nor will I document if I have made such a plan during meetings; and similarly I will not give an FTC lawyer any testimony to prompt scrutiny. But I will preserve the purity of my cash flow and my not-for-profit operating surplus.

I will not exceed my budget, even for patients in whom disease is manifest; I will meddle in all operations to be performed by practitioners, specialists in this art.

In every house where I come I will enter only for the good of gainsharing, keeping myself far from all appearance of any intentional ill-doing and all seduction and especially from the pleasures of finally controlling doctors, be they salaried or slaves.

All that may come to my knowledge in the exercise of my electronic records or in daily flow of information, which ought not to be shared with other competing providers appearing on area billboards as “Top 100,” I will keep secret and will never reveal.

If I keep this oath faithfully, may I enjoy my life and practice my art, be mentioned in glowing Congressional testimony or a State of the Union address and in all times; but if I swerve from it or violate it, may all my assets be absorbed by a for-profit investor owned health care system.

Once the regulations get published and the ACOs get selected for the national pilot program, the DMCB looks forward to seeing the Oath administered to the suits at an appropriate White House ceremony.

Mixing Social Media and Health Care: Concocting a Worst Case Scenario Using Big Pharma and Manipulated Web 2.0 Writers

Are there any downsides to the mixing of social media and health care? An interesting "Perspective" article by Boston academicians Jeremy Greene and Aaron Kesselheim in the latest New England Journal (not online yet, but check back for the link) says "yes" by taking the worst of both worlds: misinformed and manipulated Web 2.0 writers on one side and the misbehaving pharmaceutical industry on the other.

They point out that the pharmaceutical industry's marketing has generally been under very tight control by the Food and Drug Administration (FDA). Ironically, however, it was the FDA's guidelines surrounding direct to consumer (DTC) advertising that ultimately unleashed the glut of dry eye, erectile dysfunction and when diet 'n exercise-are-not-enough high cholesterol TV commercials. Well, following a November 2009 hearing on the matter, the FDA is now gearing up to issue guidance on the use of social media in pharmaceutical advertising. Once that happens, we can expect a considerable portion of the pharmaceutical industry's annual $4 billion budget to be spent on product-promoting bloggery, tweets and friending.

Which worries Drs. Greene and Kesselheim. They fear that authors of blogs, Facebook accounts and Twitter feeds that have only nice things to say about drugs or their manufacturers may be paid, biased, not credible or have hidden conflicts of interest. To deal with this, the authors suggest holding both the pharmaceutical industry and the FDA "responsible" for any significant misinformation and raise the possibility of creating a Web 2.0 FDA "seal of approval" to promote accurate content.

While worst case scenarios can be instructive, the DMCB isn't convinced that even the pharmaceutical industry's billions are up to the task of bending a truly massive and hyper-distributed social media global network to their will. What's more, pharma's tarnished reputation has already attracted the attention of legions of simultaneously smart and hostile bloggers, who seem more than ready to counter any product claims - including the credible ones. Last but not least, the DMCB is coming to doubt any laughably "responsible" Federal agency's ability to do anything quickly, cheaply or effectively. Better to let the bloggers establish their own reputations for transparency and pursue their own seals of journalistic/scientific excellence, perhaps through resources like this.

Last but not least, the DMCB is a believer in open and democratic discourse. Trying to influence the free flow of information, even if the filters are contrived by well-meaning do-gooders in some windowless room at the FDA, just seems to have too many downsides. If anything, the FDA should be working to promote an independent, skeptical and vibrant Web 2.0 scientific community. After that, they should get out of their way.

Image from Wikipedia

Do Accountable Care Organizations (ACOs) Save Money? Or Better Yet, Will We Ever Know For Sure?

The Disease Management Care Blog doesn't know. And that's just for starters.

Confused? So is the DMCB.

It touched on the topic of cost savings in this prior post when it pointed out that one of three cost scenarios for Accountable Care Organizations (ACOs) was possible: 1) no savings, 2) one time savings and 3) cumulative savings, otherwise known as bending the cost curve. "Paul N" left a reader comment to that ACO posting, asking the DMCB to "please explain."

Well, perceptive reader, the least the flummoxed DMCB can do is visually display the three possible outcomes:

First of all, this display of possible ACO cost outcomes over time assumes that there will a continuing year-over-year increase that will never go to zero. The solid blue toward the left represents the baseline rate of increase. Once the ACO is formed, this baseline trend can 1) continue unabated (the blue dotted line) or 2) slow down (the red dotted line). If the savings are "one time", the rate of cost increases will revert back. It will parallel what would have happened if the ACO hadn't been formed (that's the solid red line). However, if cost inflation continues to stay down, the rate of increase will have a lower slope i.e., the Holy Grail of "curve bending" will have been achieved (that's the green line) when you decide to remeasure at the Follow-Up point in time.

The DMCB thinks it's possible to have a "one time" savings scenario if there are one time improvements: hospital beds are temporarily closed, physician staff is consolidated and surgeries are delayed. The cost curve will swing back up, however, if beds, staff and surgeries expand or if efficiencies allow the system to "do more with less." Given the legendary levels of waste in any health care system (for example, here, here and here), that scenario is quite likely.

However, not only is the DMCB saying it doesn't currently know how this ACO "savings" business will work out, it is also predicting that it won't ever know for sure. That's because ACOs won't be operating in a vacuum: while we're tracking their costs over time, various parts of the Accountable Care Act will be kicking in (including subsidized insurance with exchanges), new "must have" drugs or technologies will continue to come on line or unemployment may drop (yes, it makes a difference). What's more, ACOs may find new business lines or become predatory monopolies and make financial mischief of their own.

All those moving parts will create a lot of background noise, making it difficult - despite any sophisticated statistical modeling - to confidently discern any real ACO "music" through all the static. Overseen by an under-resourced and inflexible CMS and loaded with obscure statistical methodologies, endless caveats and actuarial assumptions, the DMCB is afraid that the future reports on "ACO savings" will be the laced with bias, spin and conflicting endpoints strung out over the course of many years.

The DMCB welcomes comments from readers with better insights into health economics.

The Latest Cavalcade of Risk Is Up!

The Disease Management Care Blog apologizes for this tardy alert to readers about the pre-Thanksgiving Cavalcade of Risk. Louise Norris of the Colorado Health Insurance Insider has laid out a repast of summarized links to the latest, the bestest and the brightest of risk-related bloggery. After sampling some of this intellectual feast, your hunger for wisdom and insight will be long gone. You can check it out here.

Can't Trust Health Insurers or Government With Private Data: The Irony of the Genetic Information Non-Discrimination Act & Airport Security Pat Downs

At a conference last spring, a Pennsylvania Congressman repeated the tiresome political canard that health insurers' collection of their customers' genetic data would lead to systematic discrimination. The Disease Management Care Blog raised its hand and pointed out that the evidence of such bias was largely anecdotal. What's more, it said, insurers have a duty to underwriting accuracy in the individual market. Wouldn't it be better, said the DMCB, if Congress developed policy in concert with the supporting State regulations that reconciled the small risk of abuse against the greater good of insurers finding and helping patients who could benefit from early intervention and treatment?

The bombastic reply was telling: that makes no difference, he said, because the federal government can't "trust" insurers to do the right thing.

Round over, Congressman 1, DMCB 0.

Which is why the DMCB appreciates the irony of the "you touch my junk and I’m going to have you arrested" pickle that the Transportation Security Administration finds itself in. Courtesy of its government, U.S. air travelers are undergoing humiliating and upsetting "assaults." Has it really come down to this? Really?

The acerbic Charles Krauthammer, representing the conservatives in this matter, has a solution. Writing in a recent column in Washington Post, he points out that the Feds should pursue another approach: they can profile passengers and focus screening on persons that represent a measurably higher level of risk. Of course, that would involve computerized "strip searches" of our personal data, leading to the kind of analytics that are not only politically incorrect and but potentially invasive, discriminatory and unconstitutional. In response to Americans' frustrations, the President says he's feeling our pain, but isn't about to tell the TSA to stand down.

So the DMCB has to hand it to the government: at least they're being consistent. If health insurers can't profile their enrollees and use their data against them, the government shouldn't be able to profile travelers and use that information either. Health insurance enrollees are giving up genetic screening programs, counseling, additional testing and treatment in exchange for their genetic privacy. Air travelers are trading radiation, virtual nudity and some groping in exchange for their religious, national, family and personal anonymity.

It appears we've concluded that neither the government or the health insurers can be trusted. And for that decision, we'll all be treated equally crummy.

How Things Stand Now With the Politics of Health Reform: A Summary from the New England Journal

Maybe the Disease Management Care Blog is reading too much of the New England Journal, but it liked Dr. Oberlander’s analysis of the morbid politics of health reform. This is a good update of how things stand and what to watch for in the coming months.

To wit:

The resurgent Republicans' seem to have a threefold battle plan:

1) Symbolism with hopeless attempts to repeal Obamacare, having noisy hearings and forcing votes that embarrass their political opponents, all designed to cater to a political base,

2) Pointed attacks, using their majority in the House of Representatives to fiscally castrate the more unpalatable components of the law, such as the Independent Payment Advisory Board or "the mandate" by refusing the necessary appropriations. While not mentioned in the article, the DMCB also wonders if the Republicans will get in the "weeds" and make mischief in the wording of the enabling reglations behind the ACA.

3) Seeking political advantage by building on the political momentum of the 2010 elections by forcing their Democratic opponents – including the President – to "resell" the Affordable Care Act (ACA) in 2012. Not only will they have to champion a law that is unpopular among many voters, but they will have to deal with its “identity crisis.” In other words, the ACA, which is a complex amalgam of consecutive programs, new subsidies and complex regulations, has failed to achieve a single “story” or recognizable brand. This is not like the "Civil Rights" legislation of the 1960's.

What is high stake politics, however, without some risk? Parts of the ACA are popular (coverage of children through age 26 and no lifetime limits, for example) and it’s not like the Republicans have any easy answers of their own that control costs, maintain insurance coverage and doesn’t add to the deficit. It remains to be seen how they will deal with this.

Two additional wild cards are 1) the States, many of which may resist going along with the health reform law and 2) the Courts’ rulings on the Constitutionality of the law. Both seem to favor the Republicans, because even if the States are forced to cooperate and the law is ultimately ruled constitutional, the drawn out political and legal wrangling may prompt voters to doubt the law’s legitimacy.

Right now, this political tide favors the Republicans. The turbulence favors bloggers. Stay tuned.

Health Technology Is Not Sufficient When It Comes to Disease Management

The Disease Management Care Blog has always been suspicious of the health information technology (HIT) community's claims that their stand-alone and dehumanized robo-calls, passive monitoring systems, web-based learning offerings and computer-generated patient "messagings" are a population-based quality and cost panacea. While the DMCB may be old fashioned, it's always thought that HIT can add value and can be necessary but will never be completely sufficient. This HIT hubris contrasts with disease management programs, which package an array of high tech and high touch interventions into a mutually supporting whole that is greater than the sum of its parts.

Case in point is this study that was just published in the New England Journal of Medicine. Authored by Sarwat Chaudhry et al, the "Telemonitoring to Improve Heart Failure Outcomes Trial" (Tele-HF) randomly assigned recently discharged heart failure patients to one of two treatment arms: 1) an intervention group, that was asked to make daily call into a computer controlled system that generated an automated series of questions about health status, such as the presence of shortness of breath or fluid gain; if there was a decline, the patient's physician's office was alerted, or 2) usual care without any patient calls.

826 patients were in the telemonitoring arm and 827 were in the usual care arm. Over the 180 days following entry into the study, the number of readmissions, days in the hospital and death rates were compared. Since not all patients used the system as prescribed (14% didn't use the phone even once and toward the end of the study, about 55% were calling in at least three times a week), the analysis was correctly performed on an "intention to treat" basis.

There was no difference in outcomes. About 49% and 47% of the patients in the intervention and treatment arms, respectively, ended up being admitted. 27% of both arms were admitted for treatment of their heart failure. 11% of the patients in both arms died.

The DMCB is not surprised at the shortcoming of heart failure telemonitoring. Years ago, it agreed to implement a similar stand-alone program and came away very unimpressed. The DMCB thought that much more was needed, sch as nurse-based patient coaching, promulgation of evidence-based guidelines, identification and triage of patients with different levels of risk and facilitated access to an array of specialist and community-based programs.

In fact, the authors of the study would seem to agree with the DMCB. In the Discussion section of the paper, the DMCB found this very telling quote that couldn't have said it better:

In a previous, small, single-site trial of remote monitoring of patients, our group found a 44-percentage-point reduction in the rate of readmission, which was associated with significant cost savings. However, we were concerned that, in that trial, reliance on a single, highly skilled and motivated nurse case-manager who deployed an intervention developed by the investigative team limited the generalizability and scalability of the findings (bolding DMCB).

The DMCB says that's the point. Interventions like telemonitoring only add value when they are mixed with other population-based interventions, such as motivated nurse care coaches and coordinators.

However, the authors - as is generally typical of the mainstream academic community - also got it wrong. There is a sector of the health care industry that has figured out how to overcome the limited "generalizable and scalability" that is mentioned above.

It's called disease management. The DMCB thinks the failure to recognize that by not including that principle in the study design took an otherwise very promising intervention and made it look unnecessarily bad.

Patients with heart failure deserve better.

A Business Plan For Wellness: How One Company Does It (Gaming?)

Interested in checking out the business model behind an honest-to-goodness wellness company? Well, look no further than this supplement to the latest issue of the Population Health Management Journal titled “Preventive Medicine: a Ready Solution for a Health Care System in Crisis.” Written by Janice Clark R.N., it instructively describes in considerable detail how one company sells its wares. The Disease Management Care Blog thought this was interesting because there were some wrinkles to this wellness business that it had not considered before.

The product consists of a “suite” of services that include general wellness and prevention, screening/early detection, chronic condition management, senior wellness, children’s prevention and an “executive” care. Each module includes an assessment (a health risk appraisal, labs, personalized summary with recommendations and assistance with planning that includes an on-line personal health record) that ultimately generates a “personal risk analysis” with a “customized” “road-map plan.” This plan, in turn, is paired with other interventions such as access to on-line learning resources, instructional videos, telephonic coaching, access to a nurse “advocate” or, if preferred, a physician. Participants are then targeted by “Action Programs” that prompt participants to “connect” to individualized and ongoing prevention activities.

There is also the option of gaming. The games consist of “challenges and contests” that earn "points." Examples include on-line calculators that convert self-recorded activities into “miles” on a virtual Iditarod or Pony Express. As the miles build up, points can be earned that earn entry into random drawings for shopping sprees or cruise packages.

Even if gaming is not your thing, the points still count. Signing up for wellness earns a minimum of one point. As additional testing, activity participation and lifestyle changes accumulate, persons can look forward to achieving a maximum of 1000 points. They can also form teams that combine their points with other individuals in competitions that also lead to rewards such as taking possession of the coveted “Prevention Cup.” This can be intra as well as inter company.

The DMCB suspects this business is really aimed at self-insured entities, though there is little to prevent a commercial insurer from offering it to its customers on a "pass-through" basis. The company charges a fee per participant that is apparently adjusted to the service offerings described above. While all persons are automatically enrolled in its programs (which earns that one point), the company only gets paid when individuals actually participate. This gives the company an incentive to sign up as many persons as possible. While self-insured companies may be reluctant to take on the additional cost of a wellness program, there are ways around this. For example, the article describes “mid-Atlantic care dealer” that surcharged non-participating employees’ health insurance premiums that went to pay for wellness. This made its costs “budget neutral.”

So what pointers did DMCB find interesting?

When it comes to wellness, offer a lot of stuff, make it look scientific and be retail, not wholesale. While the DMCB believes it all comes down to eating less, exercising more, taking your pills and being personally engaged, the notion that this can be packaged as an individualized and sophisticated offering appears to have a special luster in the marketplace.

Turn-key scalability helps. While there may be some health insurers, CEOs, human resource managers and unions that have unique notions on how wellness should be delivered, there are other buyers who simply want the equivalent of a plug n’ play service contract. This is their answer.

At lot can be done on-line. That being said, if customers want to buy-up to human interaction (including docs), no service is too small and no fee is too big.

Gaming? Last but not least, the DMCB is intrigued by the notion that grown-ups would be actually be ensnared by the “Iditarod,” the “Pony Express” and competitions. Surely, thinks the clinically grounded DMCB, all adults should believe that wellness is for wellness’ sake, but that seems not to be the case. If this company has invested in such silliness, maybe it’s not so silly after all.

The Slow Decay Economics of a Failure to Fix the Looming December 1 Sustainable Growth Rate (SGR) Cut

Well it's started.

The AMA President predicts "catastrophe" if the cuts mandated by Medicare's complicated Sustained Growth Rate (SGR) formula go through on Dec 1. The Disease Management Care Blog's state medical society has alerted it to a "national white-coat call-in day" campaign aimed at members of the U.S. Senate. While Congress has repeatedly intervened with temporary legislation to block those cuts, it's unclear to the DMCB how the partisan survivors in a lame duck Congress will respond to this latest crisis of its own making. Will the legislators vote in another temporary increase? Will they view this as their chance to demonstrate fiscal fortitude? Will there be gridlock?

In prior posts, the DMCB has pointed out that implications of a Medicare fee schedule cut would be enormous. That being said, however, it isn't convinced that complete Medicare boycott would necessarily commence at midnight December 1.

That's because of how many physicians "develop" their practices.

"Develop" you ask? Read on.

Most young physicians accrue their clinical panels over a number of years, one patient at a time. These patients arrive myriad ways: via referrals from other physicians, community word of mouth and hospital discharges. Most new patients are kept, while some (because of interpersonal conflicts, unwillingness to establish an enduring doctor-patient relationship and/or lack of insurance or economic means) are not given follow-up appointments. Once a large enough patient population is established to maintain practice income (in primary care, that can be between 2000-3000 patients), the practice is generally closed and the physicians "graze" off their assigned population. As relatively small numbers of patients turn over (thanks to moving away or dying), small numbers of new patients are brought on. That's why retiring physicians can "sell" their practice after retirement for hefty sums of money: it's a business that comes with a established cash flow that has taken years to nurture.

Over the years, established patients may change or lose jobs, or they may change or lose their health insurance. For physicians, that's simply part of the cost of doing business - they know that most of their patients' economic set-backs are temporary. During recessions, that can increase considerably and physician incomes can decline. But even during the good times, there is always a churn of money-losing patients in the average panel.

Last but not least, the majority of physicians generally carry a percent of patients with inadequate health insurance and limited economic means (such as Medicaid). While the willingness to put up with this varies from practice to practice, the vast majority of physicians understand that "indigent" patients are part of their social mission and cross subsidize their care. Many don't even bother billing Medicaid and just see those patients gratis.

So, the DMCB predicts that if an SGR fix fails to pass, most physicians with established practice panels will, in the short term, do what they always do: a) keep their patients (it took too long to establish them), b) manage this as more "churn," (figure maybe Congress will right things in the future) and c) remember their social mission.

Unfortunately, that will be a temporary lull. Without a meaningful correction, as the months go on and new Medicare beneficiaries start looking for a physician, clinic practices will not welcome them. For established patients, the churn may be too burdensome and become unmanageable. Physicians will equate Medicare with Medicaid/non-paying patients and be forced to reduce that percent in their panels.

In other words, it may not show up as an immediate crisis. Instead it could be a slow decay. Not a bang.... but a whimper.

Two other points: A drop in Medicare income could force physicians to reconsider the economics of buying an electronic health record in the next year. In addition, physicians are becoming extremely wary of a fickle Federal government, which is quickly depleting any remaining political good will.

The Aldosterone Antagonist Eplerenone in Populations with Heart Failure: Another Task for Disease Management Programs

After the Disease Management Care Blog read this New England Journal of Medicine report back in 1999, it began to prescribe the aldosterone antagonist "spironolactone" for its patients with low ejection fraction chronic heart failure. Aldosterone is one of many normal human hormones that increase in response to a struggling heart. High levels of aldosterone contribute to a downward spiral of additional heart damage and impaired blood flow.

Unhappily, some of the DMCB patients developed dangerously high blood potassium levels. At the same time, reports of that side effect began to appear, for example here and also discussed here. Convinced that this was another example of the gulf between notions of academic efficacy and real world clinic effectiveness, the DMCB decided to return to the basic principle of "first, do no harm." It dropped spironolactone from its heart failure tool box.

With time, however, other reports like this began to appear, suggesting that if physicians were careful, spironolactone was still a good option. What's more, recommendations in favor of spironolactone appeared in the American Heart Association guidelines for the treatment of heart failure:

Recommendations Concerning Aldosterone Antagonists. The addition of low-dose aldosterone antagonists is recommended in carefully selected patients...based on the strong data demonstrating reduced death and rehospitalization in 2 clinical trial populations... For both of these major trials, patients were excluded for a serum creatinine level in excess of 2.5 mg per dL, but few patients were actually enrolled with serum creatinine levels over 1.5 mg per dL.... The average serum creatinine of enrolled patients was 1.1 mg per dL, above which there was no demonstrable benefit for survival. To minimize the risk of life-threatening hyperkalemia... patients should have initial serum creatinine less than 2.0 to 2.5 mg per dL without recent worsening and serum potassium less than 5.0 (page 1987).

And now the results from this huge international multi-site study have just been released. Over 2700 patients with heart failure who were already on aggressive state-of-the-art treatment for their heart failure were randomly assigned to another aldosterone antagonist called "eplerenone" or placebo. After 21 months, there was an absolute 7 % risk reduction for the combined end points along with statistically significant drops in deaths and hospitalizations. According to the accompanying editorial, the number-needed-to-treat (NNT) is an impressive 19. As expected, there were an increased number of patients who developed potentially dangerous increases in potassium levels in the treatment (11.8%) group vs. the placebo group 7.2%), but compared to the survival benefit, it seemed worth it.

This is noteworthy publication for the science of population health/disease management community. This report gives reason to advocate for the use of "aldosterone antagonists" in populations defined by the presence of dilated cardiomyopathy/low ejection fraction heart failure. Patients should be alerted about this treatment option, helped to understand it's risks, benefits and alternatives and coached to ask their docs about this. Since changes in kidney function can lead to high potassium levels, physicians in the real world may be understandably reluctant to start this therapy. Disease management can help by providing an important extra margin of safety by helping to make sure that patients have as well as keep any and all scheduled laboratory testing appointments. If the disease management program can get the lab test results, it can work with the physician to contact the patient to stop the medicine if there are any problems.

The Latest Health Wonk Review Is Up!

It's officially the Interdisciplinary Nursing Quality Research Initiative, but wonky smart insiders refer to it as "INQRI." That's what you'll be allowed to call it after you check out the multiple blog posts, links and summaries in INQRI's hosting of the latest Health Wonk Review. In addition to gaining further insights on the future of nursing, you can also learn about the mid-term elections, health care costs, technology and a host of other issues. Check it out!

More On the "Call for Comments" and Here's One From JD Salinger's Fat Lady

The Disease Management Care Blog has gotten some terrific one sentence 'messages' in response to its "call for comments" to share at an upcoming U.S. medical school lecture. If your submission has not appeared anywhere among the DMCB's vast array of web portals, fear not: it's in there. Your comments are being compiled with others, dropped into PowerPoint and will likely appear in a future DMCB posting.

Comments are still being accepted through early next week. This is your chance to educate, impress and influence a roomful of future doctors. Posts here, email, tweet, Facebook and LinkedIn are all accepted.

By the way, the DMCB is **NOT** going to teach about, let alone mention, "disease management." Rather, the lecture will deal with various approaches to health care financing and risk transfer.

The DMCB is planning to conclude the lecture with a comment that touches on a favorite topic borrowed from J.D. Salinger's literary masterpiece Franny and Zooey. That would be the "Fat Lady," or how contemplation, reverence, submission and service can can light up the universe that lingers just beyond the reach of rational thought. This is the astonishing insight from brother Zooey that pulls the gifted radio star Franny Glass out of her nihilistic funk.

Physicians are especially privileged because they have a leg up on discovering their own personal Fat Lady. She exists in every patient and she calls to us. And she is now telling us that, while diagnosis and treatment are still "Job One," we docs are also being called to apply new skills in reconciling ethics, financing, public health, health literacy, lifestyle issues, socioeconomic status and third party meddling:

Zooey's explanation to Franny:

[I was told] to shine my shoes...I was furious. The studio audience were all morons, the announcer was a moron, the sponsors were morons, and I just damn well wasn't going to shine my shoes for them... I said they couldn't see them anyway, where we sat. He said to shine them anyway. He said to shine them for the Fat Lady. I didn't know what the hell he was talking about, but he [had a] ... look on his face, and so I did it. He never did tell me who the Fat Lady was, but I shined my shoes for the Fat Lady every time I ever went on the air again -- This terribly clear, clear picture of the Fat Lady formed in my mind. I had her sitting on this porch all day, swatting flies, with her radio going full-blast from morning till night. I figured the heat was terrible, and she probably had cancer, and -- I don't know. Anyway, it seemed goddamn clear why [I had to] shine my shoes when I went on the air. It made sense.

And now the Fat Lady is telling physicians that while morons abound, understanding the principles underlying risk transfer and how insurance works is important because will help you get your patients the care that they need. In other words, knowing how and why health care services are financed and what can be done about it at the individual patient level is no longer the job of that lady sitting on that porch.

Here's the DMCB comment: Docs need to shine those shoes.

More on the Uncertain Economics of Accountable Care Organizations (ACOs)

In this last post about Accountable Care Organizations (ACOs), the Disease Management Care Blog promised to take a follow-up look at how ACOs will get paid and how they can save money. It's a good thing that it didn't say that it would explain how the economics will work, because it promises to be very complicated. So says the DMCB, thanks to insights gleaned from reading this Integrated Healthcare Association White Paper again. This is a very insightful report that looks at the experience of the California market when it comes to the dizzying mix of fee-for-service, capitation and shared savings medical group contracting arrangements.

First off - and assuming ACOs really do save money - if multiple insurers in a State are all contracting equally with multiple ACOs, no single insurer will experience any lasting economic benefit. That's because the savings from any efficiency gains would be spread out throughout the risk pool and be a one-time event. What's more, if a single ACO attempts to compete on price by underbidding its rivals, it's unlikely that the insurers will collectively see any significant drop in overall costs, which means that consumers won't ultimately see any decrease in their premiums. The DMCB thinks that one way to fix this is to allow ACOs and insurers to enter into semi or fully exclusive contracting arrangements. Unfortunately, this has implications for consumer choice (would patients agree to be locked or incented into using only one ACO's physicians?) and could perpetuate the "most favored nation" contracting dysfunction.

Secondly, organized physician entities and their hospitals have been very reluctant to agree to capitation for their pricier services. As a result, capitation is typically applied to low cost high volume services like primary care. Given how shrewd providers are about the financial risks from capitation, the DMCB suspects that if hospitals readily agree to more modest arrangements like "shared risk" and "gainshares," that will signal their belief that they can get more money from the deal. This increased cost obviously won't translate into lower insurance premiums for consumers, unless providers are willing to accept significant up-front reductions in their fee schedules. That is unlikely.

Last but not least, the organized physician entities and hospitals have only just begun to enter into various performance-based, risk pool and gain share arrangements. This makes it too early to tell how this will work in "real world" markets that exist outside integrated delivery systems. This reminds the DMCB that if the authors of the Affordable Care Act were sure that ACOs really do save money, they wouldn't have set it up as a pilot program.

Given all the uncertainty, the best approach to implementing ACOs may be one of "incrementalism." That would minimize unintended consequences and allow for small changes to accumulate over time. Unfortunately, that would take years. Add to that the time it will take to evaluate the impact on cost and quality, and the U.S will be many years into additional cost inflation, changing political landscapes and new economic challenges.

Bottom line: there are too many economic uncertainties about ACOs. If anyone tells you otherwise, don't believe it.

A Call for Comments

In just over one week, the Disease Management Care Blog will be doing something that only few ever get to experience: it will have the undivided attention of an entire U.S. medical school class for over an hour. It was invited to give a real and honest to goodness lecture. It's been working on the reading list, assembling the lecture content and buffing the slide presentation for weeks. And the DMCB doesn't intend to go into this alone. It would like to take its readers along by offering them the chance to communicate with these young physicians.

This is a call for a short one sentence (or less) statement that can fit with others on one or two closing PowerPoint slides, sort of like the closing credits to a satisfying movie. Angry, abusive, lecturing or depressing comments will be rejected. The DMCB is looking for wittiness, optimism, inspiration and humor.

If you have something important to say to a group of professionals who will be saving lives, spending gazillions of your tax dollars while being in the eye of an unending health reform storm, this is your chance. Email the DMCB at jaansATaolDOTcom, Tweet, or post here, or on Facebook or LinkedIn.

No Relationship Between Primary Care and Deaths from Coronary Artery Disease?

Listen in on the average health care Conference, Meeting or Grand Rounds with health care patriarchs or D.C. brainiacs speaking about "primary care," and it's likely that you'll hear at least one PowerPoint slide's worth of praise for PCPs. It reminds the Disease Management Care Blog of what it's read about about the hollow admiration of the Saudis for their hardy Bedouins, the Norwegians for their rugged Laplanders and the Ben and Jerrys for their Vermont dairy farmers. Sure, these special folks may deserve special regard, but no one actually wants to live in a desert, above the Arctic Circle or close to a smelly barn. All the special attention is of small comfort us PCPs who just can't seem to get any respect.

And now this study isn't helping at all. Titled "Association of Features of Primary Health Care with Coronary Heart Disease Mortality," it was published in the November 10 issue of JAMA. Louis Levene, Richard Baker, John Bankart and Kamlesh Khunti accessed ALL of England's health data on mortality, patient characteristics and primary care delivery to explore the relationship between heart disease deaths and the local availability of primary care. This was an impressive study involving 54.3 million Brits being cared for in 152 of their regional "trusts." Regression analysis was used to determine if there was any statistical correlation between deaths from heart disease versus race, socioeconomic status (a "multiple deprivation" index), tobacco use, weight, diabetes, high blood pressure, number of physicians, staff and practices and pay for performance bonuses that were awarded to the docs.

Based on common wisdom, most persons would think that all of the above factors are independently and statistically significantly correlated with death rates. Thousands of DMCB readers know otherwise. That's because they know primary care is not the panacea for all that ails health care and that the DMCB likes to look at published research that goes contrary to the common wisdom.

It turns out that only five characteristics were associated with heart attack death. The risks were 1) being white, 2) having a low socioeconomic status, 3) using tobacco and 4) being diabetic. Having high blood pressure detected (this is not the same as having high blood pressure: patients can have hypertension that goes undetected) was associated with less risk.

What turned out to have no impact was availability or the quality of primary care. According to the authors:

"Neither provision of primary health care as indicated by the numbers of physicians or staff per 100 000 population, nor clinical performance as reflected by the quality and outcomes framework indicator scores predicted mortality in any year."

This should give pause to the universal assumption that manufacturing and then parachuting more PCPs into areas of the U.S. with a high burden of coronary artery disease and showering them with pay for performance dollars will save lives.

As an aside, that was also the conclusion of this recently published RAND review paper from Health Affairs titled "Primary Care: A Critical Review of the Evidence On Quality and Cost of Care." The authors state:

"....a recent survey of primary care physicians found that those in the highest-spending regions of the Dartmouth Atlas of Health Care were significantly more likely than those in the lowest-spending regions to report more aggressive use of discretionary visits, tests, and interventions. In other words, care by primary care physicians in high-cost areas is not the same as care delivered by primary care physicians in low-cost areas. This finding ....suggests that adding more primary care physicians in regions such as South Florida may increase mortality rates. Such analyses offer evidence that adding more primary care providers in high-spending areas could have deleterious effects if local provider cultures and other system-level characteristics are not simultaneously reoriented."

Of course, there are other studies on the topic that say otherwise and England isn't the same as the United States. Time will tell.

One last point: the good news about the JAMA paper is that the detection of high blood pressure seems to pay off. If population-based detection and pursuit of hypertension is what counts and it's independent of the availability of primary care physicians, there are other population-based solutions available. It's called disease management. Examples are here and here.

Image from Wikipedia

Insurers Need to Say No to an ACO If There Is No Dr. No

The Disease Management Care Blog knows that a key ingredient for the economic success of any the health care system is the ability of someone somewhere to say "no." The only issue is who is responsible for actually saying it. Conservatives seem to prefer a perfectly transparent and competitive free market, where that job is up to the consumers. Progressives like the idea of a perfectly regulated system, where saying no is up to a responsive, objective and fiduciary board or group of experts.

And in Accountable Care Organizations (ACOs), it's going to be up to "Dr. No."

What is this apostasy, you ask? Regular DMCB already readers know that ACOs are provider organizations that are responsible for quality and cost for at least 5000 beneficiaries, possess a formal legal structure, have a critical mass of primary care providers, can report outcomes, have a central administration and promote evidence-based medicine as well as patient centeredness. ACOs also happen to be the Affordable Care Act's gamble that health care costs can be brought to heel through bundled payments and shared savings. That should be enough, right?

The skeptical DMCB doesn't think so. It suggests that while all those ingredients are necessary for ACOs, they're not going to succeed without a readily identifiable and tough "Dr. No" who is high up in the organizational hierarchy.

And who is Dr. No? The DMCB suggests this is the accomplished, seasoned and middle-aged physician-administrator who understands that ACOs are another wrinkle in the game of "risk transfer." He or she will grasp that there can be little hope of recouping the investments in coordinated care and information systems without controlling healthcare utilization. That means fewer "preference sensitive" procedures, less reliance on pricey specialty-based care and attacking unnecessary variation. That translates into using guidelines, medical evidence and crabbiness to enforce appropriate use of joint replacements, MRI scans and cardiac catheterizations. That means telling Dr. McDreamy he has to work in a standardized operating room, Dr. House that he'll need to discharge the patient and perform that follow-up testing on an outpatient basis and Drs. Nick n' Tuck to stop trying to convince the insurers that post-bariatric abdominoplasties are medically necessary.

The DMCB used to think that George C Scott's Dr. Bock character from the 1970's black comedy The Hospital might be able to fill the role of Dr. No. The DMCB changed it's mind after seeing Enoch "Nucky" Thompson of HBO's Boardwalk Empire in action. True, he's not a physician, but this gangster-politician has what it takes: being a shrewd judge of character, accepting personal foibles, able to turn on the charm when necessary and being cold-blooded when it's called for, all in the name of keeping the eye on the prize. Nucky is perfectly qualified to run an ACO.

As commercial and government insurers start getting into the weeds of contracting with newborn ACOs, the DMCB recommends that they not only ask about all that usual stuff of about monitoring quality and costs, supplying enough PCPs to service the population, using information technology and fairly distributing any upside gain shares. They will also need to ask about and meet Dr. No. If the ACO leadership doesn't understand, health insurers will need to think again. If they are introduced to Dr. No and he turns out to be a cheerful Colonel Potter (MASH), a cherry-cheeked Doogie Howser or a vacuous Dr. Dorian (of Scrubs), they'll have to reconsider the terms of the contracting.

No Dr. No? Walk away from the deal.

California: The Learning Lab Ecosystem for Accountable Care Organizations (ACOs)

Want some pointers on how to assemble your Accountable Care Organizations (ACOs)? Look no further than lessons from the "ACO ecosystem," otherwise known as The State of California. At least that's the message of this Integrated Healthcare Association "white paper," authored by James Robinson and Emma Dolan. For ACO wannabes, the Disease Management Care Blog says this is "must" reading.

It turns out that The Golden State has hundreds of Independent Practice Associations (IPAs) and Integrated Medical Groups (IMGs), many of which already appear to meet or exceed the emerging definition of ACOs. Their experience to date can be very instructive.

Some of the more important points gleaned from the report by the Disease Management Care Blog:

How much integration is really necessary? If California is any guide, financial success and market dominance doesn't appear to correlate with the degree of integration. Instead, clinical quality and profitability are a function of culture, HIT infrastructure, administrative leadership and the alignment of the physicians with the organization's goals. To be successful, nascent ACOs don't need to be highly integrated.

Put physicians on salary and you own them, right? Not exactly. Docs need to feel accountable, have ownership, get performance feedback and agree with the ACO's goals. They also need advanced care coordination capabilities and access to coordinated chronic care teams and care management. The DMCB wonders if ACOs will need to have physicians in prominent leadership positions.

What about the patients? To succeed, ACO's will need to reconcile the twin expectations of coordinated care and unfettered patient choice. If California is any lesson, IPAs and IMGs are better at coordinating care than accommodating patient choice. They've done well in contracting with health maintenance organizations (HMOs) that lock patients into a network. They've done less well in attracting patients who are in preferred provider organizations (PPOs) and have a choice. Could this be a potential Achilles heel for Federally sponsored ACOs?

Bigger is better? Not necessarily. Large IMGs and IPA become unwieldy. What's more, smaller organizations have shown that they can outsource management are care coordination functions successfully. This is another confirmation of what the DMCB has been saying all along: ACOs and disease management vendors could be the beginning of a long friendship.

This important white paper has some other interesting pointers on how ACOs should approach the mix of capitation, fee-for-service and bonuses. That'll be addressed in a future posting.

The Magnificent Carnac Speaks to Health Care Reform!

According to a TV documentary last night, "Karnak" is a temple complex used as a beacon to guide ancient astronauts. The Disease Management Care Blog knows better. It's really Carnac, and he was an all powerful and all wise soothsayer who, from time to time, would appear on Johnny Carson. He'd amaze and astound his viewers by divinating the answers to questions he hadn't even seen yet, because they were hermetically sealed in envelopes! And if the audience was insufficiently impressed with his all-seeing prowess, he'd condemn them with terrifying curses.

Was the DMCB a victim of an insomniac twilight sleep or was it the subject of a visitation by The Magnificient One? You be the judge:

Karnak's augury:

"The Obama Administration and American physicians."

The question..... Name two groups that will need to find another line of work by 2012.

More Karnak wizardry:

"A Perfect 10!"

The question..... How many thousands of dollars will independently practicing nurses soon pay for their malpractice insurance?

(If you groaned at that one, fear Karnak's curse: "May dozens of Mini-Me Pelosis and Boehners sprout from your computer screen and lecture you about 'the American people.'"

A last Karnak enchantment:

"The Matrix, Alice's 'Wonderland' and Avatar's Planet Pandora"

The question.... Name three settings where Accountable Care Organizations have been proven to save money.

Sis boom bah!

$180,000 To Save One Life In the National Cancer Institute's National Lung Screening Trial on Helical CT Scanning For Early Detection of Lung Cancer

In its many years of clinical practice, the Disease Management Care Blog watched many ex and active smokers succumb to lung cancer. So, when a flurry of news reports today announced the "huge" finding that "spiral CT" screening saves lives, it was motivated to look at the story behind the story.

Lung cancer typically starts out as a "silent" tumor. Generally, by the time it is big enough (about 1 centimeter in diameter) to be seen on regular chest x-ray, a year has passed and the tumor may have already spread. Persons typically don't come to medical attention until the cancer is much larger, which makes the prognosis even more grim: after about 5 years, only 5% to 14% of victims are still alive.

Enter "Computed Tomographic (CT) Scanning," which uses computers to array x-ray imaging that, in turn, construct highly detailed and two (and lately three) dimensional images of the human body. Because lung tumors are solid and, in CT images, contrast nicely with the surrounding air-filled chest tissues, this imaging approach has the potential to find cancers earlier and before they've spread. Recall, however, that CT scans use a much higher dose of x-rays, which could theoretically cause cancer in a small fraction of patients. That risk was decreased by the advent of fast (within a single deep breath), low dose "helical" or spiral scans, where the patient quickly moves through the circling x-ray detectors. There's a good picture of what happens here.

The hope of earlier detection translating into chest surgery and saved lives was the basis of the National Institutes of Health (NIH) funding a large randomized trial (how the study was set up is described here) that recruited former (within the last 15 years) as well as current smokers (with at least 30 "pack-years") who were cancer free and between the ages of 55 to 74 years.

They were assigned to one of two treatment arms: 1) three yearly helical low dose scans or 2) three yearly chest x-rays. The "National Lung Screening Trial" began in August of 2002 and by April of 2004, 53,456 had been randomized in 33 U.S. research centers. The latest round of screening CT or chest x-rays was completed in the summer of 2007.

Once that was completed, it was a matter of counting death certificates.

So, after ALL that, is the counting done? Not exactly. The story behind the story is that preliminary summary results are available in a National Cancer Institute press release. A complete and detailed analysis will not be made available to the DMCB or its readers until....

"A fuller analysis, with more detailed results, [is] prepared for publication in a peer-reviewed journal within the next few months."

So exactly what does the press release say? In the first paragraph, it says there was....

"20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT."

This "20%" does seem "huge," doesn't it? Fortunately, the DMCB has been trained to look past this seductive relative risk reduction (i.e., comparing one group to the other group) for the absolute risk reduction. To the New York Times' credit, they reported the actual numbers from the press release, which noted that 354 CT scan patients died of lung cancer vs. 442 of the chest x-ray patients.

But what is the denominator? The DMCB can't find that number in the press release. Assuming, however, that the random allocation was about equal, that's 26,728 assigned CT scanning and 26,728 assigned chest x-rays. If that's true, the absolute cancer death percentages were 1.3% in the CT scan group and 1.7% in the chest x-ray group, for an absolute difference of about .4% or four in a thousand. More than 98% of both groups hadn't died of lung cancer.

At first glance, that seems like an awful lot of CT scans for a less than 1% absolute risk reduction. To put the numbers in perspective, the DMCB likes to rely on the "number needed to treat" statistic. If the numbers are inputted here, about 300 yearly CT scans will be needed to prevent one cancer death.

According to this NCI web site, helical CTs can cost between $300 and $1000. The DMCB assumes that not all of the patients assigned to the CT arm of the study got three scans (which would cost between $900 and $3000), so it'll make another assumption: the average number of CT scans was two and that the average charge was on the low side at $300 for a total of $600. If the NNT was 300 and each patient got $600 worth of CT scanning, that back of the envelope blogging calculation suggest $180,000 has to be spent to save one life from cancer.

The DMCB suggests this puts things into perspective, which so far has been missed by the national mainstream media. While there was a "20% reduction," a first time review of the press release suggests:

1) The vast majority (more than 98%) of participants did not die from lung cancer.

2) By going through yearly helical CT scanning, smokers can reduce their absolute risk by about .4% over 3 years. This is risk reduction at the margins of being meaningful.

3) The NNT is 300 and the corresponding cost of saving one life is $180,000. It's difficult for the DMCB to translate that into QALYs, but at first glance and given our budget travails, that may not be a wise use of our national treasure. To put things into perspective, consider how many long term (30 pack year) smokers there are among the over 90 million former and current tobacco users in the U.S. today, and multiply that times $600.

4) Based on these results, it's unlikely mainstream health insurers will think this is a wise use of their customers' premium dollars. It might be smarter public policy to let smokers pay for their own scans out of pocket. If they can afford a year's worth of tobacco products.......

One last DMCB point: there may be "lead time bias." Just because a cancer is found earlier in the course of disease, doesn't mean the patient is destined to live longer. It may take additional years of follow-up to see if the absolute death rate in the CT cancer group catches up to chest x-ray group.

Was the national news media beguiled by a press release that spun relative risk without the necessary information to make an informed judgment? The DMCB will find out when the complete study goes through peer review and gets published.

Stay tuned.

November 9 addendum: Thanks to a heads-up from a smart colleague, the DMCB became aware of this blogger Gary Schwitzer of HealthNewsReview also spotted the problems and has a good link to an useful NPR story.