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POLICY: Bush Plans Tax Code Overhaul, with UPDATE

Look at this trial balloon–Bush Plans Tax Code Overhaul. Getting rid of tax deductibility of health insureance as a business expense!! Are they serious? If so that really would put the cat amongst the pigeons!

UPDATE: Ross works out the logical process if this happens without some associated legislation creating the ability to buy collectively (and it must be pointed out, mandatedly with risk adjustment a la Enthoven (as the NY Times reports today). And yup, it’s not pretty

TECHNOLOGY: HIT meeting today

Thursday (Pacific time) I’ll be at the HIT meeting in San Francisco, held at PacBell SBC Park so that we don’t have to cross a picket line at the downtown hotels. I’m informed Barry Bonds won’t be there but current health care IT MYP David Brailer will, as will the rest of the good and the great of the health care IT world. There’ll be live blogging if you’re lucky and if the stadium wide Wi-Fi is all it’s cracked up to be.

POLICY: Jonathan Cohn on the politics of real reform

Jonathan Cohn, who besides being a deliriously happy Red Sox fan is a health care journalist and a senior editor at the moderately liberal New Republic, has been corresponding with me a while. (Does it bug anyone else having to keep The National Review, The New Republic and The Nation straight? Couldn’t the conservatives, the liberals and the real lefties have chosen titles with slightly different alliteration or words beginning with letters not N or R?). Jonathan’s on the book grind himself (and doubtless scared of my review!) and writes regarding my post yesterday as to why things might change in the longer term regarding reform:

Good post today about the politics of health care reform. I’ve been thinking a lot about this myself lately, as part of my book, and am starting to question the conventional wisdom that moderation plays better politically — at least in the context of a presidential campaign. Look at the election we just had. Policy wonks could (and did) make a very good case for incremental reforms like the ones Kerry proposed, and Kerry did fine on the health care issue because voters tend to trust Democrats more than Republicans on the issue if they don’t know any other information. But it’s not like Kerry’s health care plan was a major draw, and part of the reason is that it was so damn complicated it didn’t break through the policy fog.

Now consider single-payer. Put aside the debate over whether it’s really the best policy. I’m starting to wonder if — strictly in political terms — bolder isn’t better. You can explain single-payer three simple words "Medicare for all." And while that
instantly ignites a very hostile opposition, it also arms you with (a) the aura of a popular program, namely "Medicare" (b) the virtue of simplicity (c) the virtue of seeming bold.

Admittedly, selling single-payer gets much harder if you actually get elected and have to start dealing with the legislative process. Maybe you compromise at that point. But I don’t think we’re going to see *any* substantial health reforms until
somebody puts a big, bold idea — and that probably can’t happen outside the context of a presidential campaign.

Meanwhile The Prospect blog had another wild idea–let everyone join the Democratic party and let it start its own health plan. Pity they’d never heard of adverse selection. (Thanks to Jones the Policy Wonk for the tip).

QUALITY: Holding the line on 5 year anniversaries!

Like a bunch of kids sneaking downstairs to open their Christmas presents before the day comes, journalists and pundits across health care are "celebrating" the 5 year anniversary of To Err is Human, weeks before the actual day.

Don’t worry. As a bastion of blogging integrity, you can make a fair bet that THCB will lead with the story, on the actual day…

But for those of you who can’t wait there’s an article in the Pittsburgh Post Gazette here, and a survey from KFF, AHQR, and Harvard (same team as the recent NEJM article).

The conclusion is the same: we haven’t seen a whole lot of progress as yet on medical error reduction.

BLOGGING: BloggerCon session on Medblogging is up

In yet more shamelss self-promotion, a session that I participated in at BloggerCon III is up online. You can download a 33 Mb MP3 here or you can go here to find this stream in Windows Media Player or Real Audio.

It’s a long and quite interesting session, but be warned that it was pretty sparsely attended (most sessions had a couple of hundred people, we have about 10!), so you hear a lot from moderator Enoch, Dr O, med blog groupie Lisa Williams (who I think the AMA should be taking on tour) and, er, me.

Meanwhile yesterday was the biggest day ever here in terms of traffic, thanks to those coming over from Grand Rounds and the DM Forum. Thanks and please come back!

POLICY/POLITICS: What might turn the tide?

I just got back from a rather frustrating talk by veteran liberal investigative journalists Barlett and Steele, on their new book Critical Condition. These geezers have just discovered that the health care system is in a bit of a mess, for-profit players in the health system are bad, and a single payer system with a few wrinkles (in that it’ll be run like the Fed not the Medicare program) will fix it. While these two veterans have done great work looking at the transformation of the American economy and its impact on the lower end of our society in the 1980s and 1990s, their health care speech was a hackneyed re-tilling of ground gone over by many others before. I have much sympathy with their cause, but they didn’t generate one new idea in their talk, and they made several basic mistakes — such as not being able to explain why non-profit hospitals make more money from doing more procedures. Neither for that matter could either of them explain to the moderator, (the silky-voiced but ignorant of the health care system Scott Shafer), why Kaiser was different to a typical non-profit hospital chain. They many times confused the problems of over-use, under-use, system quality, and uninsurance, and basically added to the fog that surrounds this whole issue. The short discussion group which I joined afterwards was full of health care professionals even more confused than when they arrived.

Finally Barlett and Steele gave no reason as to how, in a nation which for better or worse — OK, OK for worse — just re-elected a President and a Congress with no interest in either cost-control or covering the uninsured, we are gong to get serious health reform. They suggested it would take a a collapse of employment-based health insurance and an increase in the uninsured up to 90 million. Well no matter how rough it is, things are not getting that bad in the next decade barring a massive 1930s style depression

Realistically we are not getting reform in the next 4 years and probably not in the next 8. But there are seeds of the environment for wider-scale reform if you care to look for them. Here are two culled from the business pages.

The first is from that commie rag The Wall Street Journal which reports that health insurers often reject the ‘Near Elderly’:

Though health insurance is an issue that affects young and old alike, it is a particularly tough problem for people aged 50 to 64 who are too young for Medicare, the government’s health program that covers those aged 65 and over. As a group, they are often vulnerable to layoffs or pushed into early retirement at a point in their careers when it is difficult to get another job with benefits. Those who retire early thinking they are covered may see their benefits scaled back, as employers have tried to cut these costs in recent years. Still others lose coverage when an older spouse switches to Medicare from a plan that had formerly covered both members of the couple.

Whatever the reason, many in this pre-Medicare age group find themselves in the individual insurance market at the very time they are developing health problems that scare insurers. A recent study by the Urban Institute found an 18% uninsured rate for "near elderly" (aged 55 to 64) middle-income consumers who reported being in "good" health. That is double the uninsured rate for those who said they were in "excellent" or "very good" health. The contrast suggests that the near elderly with some health issues may have difficulty getting affordable insurance at a time in life when — unlike healthy young people who can risk going without — they need it, says John Holahan, the study’s author.

Meanwhile another bastion of sociaism, General Motors Corp., recently reported reduced earnings, due in large part to its out of control health care expenditures.

Putting these two factors together we can see the makings of a coalition. The Bush-voting Nascar dads living in the red states will increasingly find that as they age into near-Medicare, they are getting laid off from their full-time jobs, scrambling around in the temporary or contract labor force, and having a terrible time getting health insurance. And if you want to check how bad, even the WSJ couldn’t come up with one

decent strategy for buying health insurance. Although they didn’t mention the obvious choice of moving to Canada, they did mention that you’d do better if you didn’t get sick or use any health services. No shit, Sherlock.

So if you have a grumpy bunch of red-state Republican voters who might be persuaded to vote for someone who can fix their uninsurance problem in a non-threatening way (extending Medicare to all perhaps?), and you have big business sector that not only says that it cant go on that way, but also starts to agitate politically to gets its liabilities onto the governments’ shoulder, then you have at least the recipe for another run at reform.

This may be the route back to the White House for the Democrats and it may be where we’ll see the real consensus emerge after the next four years of increased chaos. But even if that happens we’re a long, long way from getting real reform done.

PHARMA: Viagra wild thing ad no-noed

The Viagra "wild thing" ad was adjudged by the FDA to be too hot for prime time (or something) and has now been pulled. Over at Pharma-Mkting list serv John Mack notes:

The FDA pulled the ads because they crossed the line for "reminder ads" – a line that will now be a precedent for judging other reminder ads. But just where is that line? Why don’t the Levitra and Cialis ads also cross that line? If, as mentioned in the WSJ, a woman wearing a man’s loose dress shirt is advertising short-hand for a woman who recently has had sex, why didn’t FDA pull the Levritra ads? Eye of the beholder…

…which gives me the chance to show this great Boondocks cartoon about the first Levitra ads, with the guy throwing the football through the tire (get it? get it??)

QUALITY: Which parts of DSM do make sense, by Gordon Norman

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.

PHARMA: 60 Minutes piles in more on Vioxx

60 Minutes had a second (or third) to market piece on Vioxx on Sunday night. It’s about time CBS had a fish in a barrel to shoot, given their complete horlicks they made of the "Bush desertion to rehab in Alabama" story. But they shot this fish, although I don’t think there’s anything new here. Other, of course, that middle America doesn’t read the WSJ or the NY Times, but they do watch 60 Minutes and now perhaps Dodgeball will no longer be a standard procedure in sales teams across America. As one wag on the PharmaMarketing list serv mentioned, how much more does it take for people in corporate America to realize that anything written down in an email may come back to bite you? As the Industry Veteran summarized the Vioxx story:

We should point out the bitter irony that the damning Vioxx memos we’ve been seeing come from Merck, the outfit long regarded as the industry’s most science-driven company and the one with the highest ethical standards. I think for four or five years in a row, they were ranked by Tom Peters or some other flack as the "Best Company to Work For." (Of course that was such a sham because they bought that designation for themselves.) Well what do you know; a memo from their head of R&D, Edward Scolnick, shows they found out in 2000 that Vioxx had a real problem but they spent the next four years trying every which way not to acknowledge it. Then they tried to intimidate researchers who wanted to study Vioxx’s cardiovascular effects, for example, telling the department chairman of an eager Stanford researcher that the latter’s career would "flame out" if he persisted. They also withdrew over $300,000 in funding from the program of a Spanish researcher who was similarly interested in Vioxx’s dangers. To really put the cherry on the whipped cream, Merck started training its sales reps to play "dodgeball" with any physicians who asked about Vioxx’s harmful cardiovascular effects. And these are the guardians of our healthcare for whom we should raise the percentage of GDP spent on healthcare to 18%?

It certainly doesn’t exactly inspire confidence, or give much justification for Bob Ingram of GSK’s latest set of demands for the rest of us to provide the pharma industry.

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