Why Would the U.S. Senate Want to Continue to Support the Medicare Coordinated Care Demonstration (MCCD) As Part of Health Reform?

The Disease Management Care Blog undertook another exploration of the U.S. Senate's 'Manager’s Amendment' to its proposed health reform legislation and discovered some interesting language on page 155.

It directs the Secretary of Health and Human Services to….

Utiliz(ing) a diverse network of providers of services and suppliers to improve care coordination for applicable individuals … with 2 or more chronic conditions and a history of prior-year hospitalization through interventions developed under the Medicare Coordinated Care Demonstration Project under section 4016 of the Balanced Budget Act (bolding from the DMCB).

Continuing the Medicare Coordinated Care Demonstration (MCCD)? Where did that come from?

Regular readers of the DMCB may recall that the MCCD was something of a disappointment that was spun in a way that would make even Madam Speaker Pelosi proud. Briefly, it was a Medicare demonstration involving 15 healthcare organizations (5 disease management organizations, 3 community hospitals, 3 academic medical centers, 1 integrated delivery system, 1 hospice, 1 long-term facility and 1 retirement community) that randomized their established Medicare fee-for-service beneficiaries with chronic illness and prior hospitalization to usual care versus being assigned care coordinators tasked with increasing patient self-care. Final fees ranged from $60 to $270 per member per month (PMPM).

Of the 14 that completed the demo, only one achieved a statistically significant reduction in hospitalizations. Two programs had a significant change in costs, but in the wrong direction: both went up. Two other programs had non-statistically significant reductions in cost; if outlier costs were deleted from the analysis, one turned statistically significant. The abstract appearing in JAMA included statements like ‘…thirteen of the 15 programs showed no significant differences in hospitalizations…,’ as well as ‘…none of the 15 programs generated net savings…’ and, last but not least, ‘these programs had favorable effects on none of the adherence measures and only a few of many quality of care indicators examined.’

Does this sound like something that should be continued as part of health reform?

DMCB doesn't blame the 14 centers for using whatever political legerdemain it took to continue the funding of this non-compete gravy train. Based on these data, however, it’s clear that while this particular nurse-coordinator model of care may have some promise, it alone is not enough to achieve the breakthroughs necessary to solve the twin health care challenges of cost and quality.

Better to use the MCCD's lessons by building an initiative (and please, not another ‘demo’) that takes what is known to work and not work from this as well as other demos and programs inside and outside of government to fashion a multi-pronged approach to population-based care. This should include the best of remote and face-to-face disease management, the medical home and other care coordination and physician led strategies. What’s more, the DMCB thinks it be smart to open this to other entities with fresh approaches. There should be a special emphasis on collaborative partnerships involving multiple players including the primary care doctors. Not only does this hold greater promise of ‘generating net savings’ and ‘having favorable effects on quality of care,’ but it’s the most likely to work in multiple settings across the country.

The Medicare Coordinated Care Demonstration (MCCD) Didn't Work: Conclusion? That the Medical Home Will Work.

You may have seen some dispirited reports (here, here, and here) about the published summary from Mathematica (Deborah Peikes, Arnold Chen, Jennifer Schore, Randall Brown: Effects of care coordination on hospitalization, quality of care and health care expenditures among medical beneficiaries) appearing in JAMA (2009;301(6):603-618) on the federally funded Medicare Coordinated Care Demonstration (MCCD). This involved a total of 15 participating healthcare entities (5 disease management organizations, 3 community hospitals, 3 academic medical centeres, 1 integrated delivery system, 1 hospice, 1 long-term facility and 1 retirement community) serving fee-for-service (FFS) Medicare beneficiaries with one of several chronic conditions. Each of the 15 entities ran their own randomized clinical trial with varying inclusion criteria and risk factors. Patients were randomly assigned to usual care vs. being assigned a care coordinator who, depending on the program, used different types of behaviorally-based patient education programs that were ultimately aimed at increasing self care. Final fees ranged from $60 to $270 per member per month (PMPM).

The Medicare beneficiaries entered into these programs were sick and therefore expensive at baseline, averaging just over $1535 per member per month (PMPM). One program had to drop out because of low enrollment. Of the 14 that were remaining, only one program reduced hospitalizations in a statistically significant manner. Two programs had a significant change in costs, but in the wrong direction: both went up. Two programs had non-statistically significant reductions in cost; if outlier costs were deleted from the analysis, one of the two programs turned statistically significant. Bottom line: Medicare funded care coordination programs for FFS beneficiaries, based on this research, will not reduce healthcare costs.

Those are the facts. But the authors of the report then went on to offer up some subjective impressions, presumably based on their close working relationship with each of the MCCD entities. The Disease Management Care Blog forgives them for going on a speculative bender - but only up to a limit.

Those subjective impressions? The care coordination programs that came close to saving money were:

a) High Touch - care coordination personnel seemed to have more face-to-face time with the patients, even if that meant travelling out to the doctors' offices to meet them. Relying exclusively on the telephone seem to have less success.

b) Not Too Hot, Not Too Cold - patients who had a low burden of disease and patients that were extremely ill continued to use little or high amounts of care, respectively, no matter what intervention was used. Programs that aimed their interventions at the 'just right' patients seemed to do best.

c) Aimed At the Pills As Well As the Ills: helping patients understand why and how they need to take their medicines seemed to be helpful, and

d) All About the Fundamentals: Keying on 1) patients when they got out of the hospital and 2) assigning care coordinators by physician (and not by the patient) kept patients out of the hospital and kept physicians from having to deal with too many nurses.

So where did the authors cross the line? You guessed it: by force-fitting their subjective impressions into an editorializing closing paragraph about the supposed virtues of the Medical Home:

'...the medical home model may be able to replicate or exceed the success of the most effective MCCD programs.'

Really? This is lecturing based on what data? The DMCB believes the statistics showed that care coordination programs failed to achieve statistically significant reductions in healthcare costs. Statistical significance was only achieved in one program when high costs were censured out of the data, which is a luxury that the real world Medicare program does not have. Finally, while the authors' impressions of successful program characteristics made sense, they selectively focused on the one that fit their unfounded admiration for a yet unproven - if promising - care strategy. As an aside, an accompanying editorial by John Ayanian of Harvard didn't do much better.

Message for the disease management organizations? Based on this article, none of this should be any surprise to you. Many in policy circles may not know it yet, but you should keep doing in the market what you've already learned to do, thanks to an ever-growing knowledge base that relies on far more than a hidebound research paradigm: for the right patient, it continues to make sense to rely on nurses that are available for in-person coaching, to use your predictive modeling algorithms to identify patients that are ''high impact,' to pursue medication adherence and persistence,to do everything possible to find and help patients that are recently discharged and to build close relationships with the primary care physicians.

Oh... as for waiting for Medicare to catch up? The DMCB isn't too sure about that. We'll see.

More on the 3rd MCCD Report: What Does It Tell Us About Disease Management? Answer: Not Much (Part 2 of 4)

The Disease Management Care Blog read the 3rd Report Third Report to Congress on the Evaluation of the Medicare Coordinated Care Demonstration (MCCD) again, with special attention to what it tells us about ‘disease management.’

The answer is: not very much.

Of the 15 participating programs, 3 were what would be considered “classic” disease management vendors: QMed, Quality Oncology and CorSolutions. Yet, in the opinion of the DMCB, these 3 entities are not truly representative of the current modern mainstream. QMed’s program revolved around the use of its proprietary heart monitor, which detects subtle evidence of coronary artery disease. It relied on physicians to initiate treatment changes. Quality Oncology’s program was postured to manage adverse treatment effects. There was patient education, but little else. CorSolutions was limited to chronic heart failure, provided patient education but appeared to have no home telemonitoring.

In other words, none of the 3 programs appeared to provide the full suite of overlapping tailored care approaches typically seen in full bore commercial DM programs. In addition, diabetes was not included for any of the DM participants.

Only one of the programs (CorSolutions) came close to mirroring what is seen in typical disease management, yet it was limited to chronic heart failure. The DMCB has tackled the topic of heart failure DM before. Success in heart failure is very dependent on targeting the right persons. Mild heart failure patients are destined to do well not matter what, while severe heart failure patients have disease that is implacably progressive. If many patients to the left or the right of the core moderate group are included, any success will be diluted. Given the mean PMPM of >$2000 in the CorSolutions cohort, the DMCB suspects they had a lot of severe patients. The odds were stacked against them.

It gets better though. QMed and Quality Oncology had a -0.2% and -1.9% change (that’s right, negative, in that it dropped) in monthly Medicare expenditures including their fees. Based on the statistics used, the analysis was unable to show this was significant. However, QMed and Quality Oncology contrast considerably with the demo’s overall mean increase of 11.3%.

What’s more, none of the changes seen for any other the groups were significant at a p equals .05 level. The threshold was lowered to .10. If you take 15 programs and toss their outcomes in the air, the likelihood of a spurious change in one of them is probably greater than 10%. Ugh.

While ‘disease management companies’ described 3 of the 15 participating programs, the other 12 consisted of hospitals, integrated delivery systems, academic health centers, long term care providers and care coordination providers. Two providers were (again, p = 0.1) cost neutral: Georgetown University (which also stuck to heart failure patients who also had a high PMPM. They dropped out early but appeared to be doing something right) and Health Quality Partners – a quality improvement service provider located in eastern Pennsylvania. If entities other than disease management vendors supply care coordination services, what do you call it? Is one good name that darling of well-meaning health policy makers everwhere, yes we're talking ‘the medical home?’

What does the DMCB conclude?

Disease management per se was really underrepresented in this apparently unsuccessful demo, and what’s more, the disease management was limited to ischemia monitoring, cancer treatment side effects and a blunt approach to heart failure. Despite that, two out of three seemed to do well. That being said, the DMCB doesn’t really think this demo was about ‘disease management.’ It was about a population approach to care incorporating many but not all of the critical features that make up modern disease management. The MCCD report's inclusion of disease management as the poster child for the lack of savings is really misinformed.

The DMCB notes that the approach to care described in this demo equally applies as badly (if not more so) to the concept of the ‘Medical Home.’ That term is conspicuously absent in this report. Why?

The DMCB still doubts that a randomized clinical trial is the best way to think about this corner of the health care enterprise. The taxpayers and decision makers in Congress deserve better.

A Prayer for the 3rd MCCD Report (Part 3 of 4)

Should prayer for those with chronic illness be covered under Medicare? Such a notion is probably an anathema to many of the level-headed readers of the Disease Management Care Blog. The remainder probably thinks the DMCB is going off on some bender. Yet, many reasonable persons believe in the intercessory ability of humans to either harness or appeal to forces that transcend logic or our five senses. On the surface, a majority of Americans would agree that it’s not that radical a concept, especially since there are some compelling anecdotes.

Leaving aside the obvious religious questions and inevitable legal objections, one way to come up with an answer would be to fashion a Demonstration, prospectively randomizing beneficiaries to control and intervention groups and then assessing the statistical significance of between-group differences in quality, cost and satisfaction. Since believers would argue not all prayer is the same, the Demo would need to test several belief systems involving multiple settings and multiple conditions. Think it silly? There have been several per-reviewed publications assessing the impact of such ‘distance-based interventions.’ All that is lacking is sufficient venture capital.

But seriously, the DMCB is not attempting to equate prayer and population-based approaches to care. However, thinking about the challenges of ‘testing prayer’ is instructive about the limits of scientific inquiry. It is very hard to simultaneously test 1) multiple, 2) interdependent, 3) socially complex and 4) variable interventions like prayer and then rely on unidimensional outcomes (like A1c or PMPM) to gauge success.

The DMCB is not being naive. It understands the similarities between prayer and disease management are a stretch (except maybe for what it will take for DM to be covered by Medicare). There are multi-million dollar disease management companies that want a place at the Medicare trough and the implications of coverage are huge. That being said, the DMCB also wonders if disease management has greater similarity to the health care quilts of community-based institutions, families and religious organizations than the more circumscribed interventions of a drug or an x-ray. Assessing multiple-packaged-interdependent-complex-variable interventions like reassurance, support and encouragement through the narrow aperture of a randomized clinical trial (RCT) just isn’t up to the task of assessing the real values of ‘care coordination.’ It also doesn’t work for other long-accepted approaches like primary care or hospice, neither which has also been evaluated in an RCT. Nor should they be.

By the way, the DMCB doesn’t think Medicare should ‘cover’ prayer, but not for the usual reasons: it’s already freely available.

Unfortunately, the acolytes of care coordination and disease management (and the Medical Home, by the way) have to play with the cards they’ve been statutorily dealt. If the path to explicit inclusion in the Medicare benefit is lined with RCT demos like MCCD and Medicare Health Support, it looks like the population-care industry is going to have a tough time. Medicare beneficiaries will be worse off for it.

What’s the fix?

Fashioning Richer Studies That Ask How, Not What: Don Berwick tells us that we need to do a better job of assessing how interventions work best. The MCCD, for example, tells us that in-person care coordination seems to have greater success than remote approaches. Duh. We already know that, but we sure could do a better job of understand the circumstances It’s doubtful that an RCT will be able to sort that out.

Assess Value, not Savings: Is it possible that in the Medicare FFS Program, care coordination strategies add cost but with comparatively greater gains in value? Suppose we found a version of disease management, inclusive of fees, that cost $50,000 per quality adjusted life year (QALY). That’d be a deal, but it wouldn't be cost saving.

The DMCB is having trouble finding the 3rd report on line. If that keeps up, it'll have to figure out how to post it here. Email if you want a copy.

Latest 3rd Report Medicare Coordinated Care Demonstration: The Good, Bad, Really Bad & Quote Most Likely to be Taken Out of Context (Part 1 of 4)

The Disease Management Care Blog obtained a copy of the latest 3rd Report Third Report to Congress on the Evaluation of the Medicare Coordinated Care Demonstration (MCCD). This is the latest four year update of the program.

The Medicare Coordinated Care Demonstration (MCCD) was included in the Balanced Budget Act of 1997 to test Care Coordination programs in Medicare fee-for-service sector. Fifteen programs in were selected to participate. They included a spectrum of commercial disease management providers, academic medical centers and hospitals in 16 States. Their programs used a mix of in-person initial assessments, home tele-monitoring, behaviorally based education and physician participation with tailored payments. The programs began in January 2001. Enrollment of the more than 18,000 beneficiaries (with a mean PMPM in excess of $2000 at baseline), who were randomly assigned to intervention and control groups, began between April and September of 2002. Fees paid to the programs per beneficiary ranged from $50-$444 per month.

According to Mathematica Policy Research, the bottom line was “most of the care coordination programs tested in this 3rd report had limited or no improvements in quality of care, few achieved cost neutrality and none reduced total Medicare expenditures when care coordination fees were included. Five programs had modest effects on quality without significantly increasing Medicare expenditures.”

Yikes. The DMCB read this through once and will continue to chew on this. In the meantime, here are some points gleaned from the report:

The Good News:

Across all programs combined, the treatment group had slightly fewer hospitalizations per year than the control group by 4.5% (p=.02). However, there was wide variation among programs and two programs in particular seemed to skew these positive results.

There were meaningful reductions in heart failure hospitalizations among patients with heart failure and among patients with diabetes.

Treatment group members were more likely to be satisfied in support and monitoring and health education. Physicians also agreed the programs made things easier.

There seemed to be noticeable increases in urine protein tests and A1c among persons with diabetes, lipids tests among persons with CAD and diabetes and there was an increase in overall flu shots and mammography.

Programs with the most in-person contact were generally more successful

The Bad News:

There was no effect on patients’ self report adherence to diet, exercise or taking medications.

No particular program types or target populations were consistently associated with favorable cost and quality outcomes

Programs lacked extensive care coordination experience and many lacked experience working with fee for service Medicare beneficiaries.

The Really Bad News

According to this analysis, increases in quality of care do not necessarily result in reduction in hospitalizations or costs.

The Quote Most Likely to be Taken Out of Context:

“Moreover, the findings contradict the oft-heard claims of disease management companies that they not only are cost neutral but substantially reduce total costs; in this demonstration, 10 of the 15 programs increased total Medicare expenditures when the costs of the intervention are included, and none of the other 5 actually reduced expenditures.”

Accountable Care Organizations & Criteria For Piloting Them in the House Reconciliation Bill: Include Disease Management & the PCMH

In another step in the high political theater of arm twisting, outright threats, secret deals, back-stabbing, towel snaps, shifting voting blocs and It Takes Courage high rhetoric, the U.S. House of Representatives' Budget Commitee has passed the 2000 plus page reconciliation legislation, which is aptly named.....(surprise) "The Reconciliation Act of 2010." It may or may not be the real thing, but hey... it's something.

That legislation was only just posted in the last 24 hours and, unlike many of the House members, the DMCB is still reading through it. A first step was to make sure "Accountable Care Organizations" (ACOs) are still included. Your diligent Disease Management Care Blog performed a scan and is happy to confirm that the concept is still there, namely in Section 1301 on page 453. ACOs will be "piloted" with two purposes: 1) reduce expenditures and (not or) 2) improve health outcomes, by a) promoting provider accountability, b) encouraging infrastructure and c) rewarding quality/efficiency. The pilots are supposed to start January 1, 2012 and last 3-5 years.

The DMCB is still confused by the notion of a "pilot." A superficial review of the bill fails to precisely define it, but the language mentions what may be a key determinant for the ACO pilot: the HHS Secretary may issue regulations that permanently implement ACOs, apparently without checking with Congress first, assuming CMS' Chief Actuary can "certify" that they save money*.

So now that we have a better handle on just what a "pilot" may be, what defines an "ACO?" According to the legislation, it still is a hospital-physician group entity that 1) has a legal structure so it can receive and disburse money, 2) has "sufficient numbers of primary care physicians," 3) is able to report on its outcomes, 4) "provides notice" to beneficiaries about the "pilot," 5) participates in a CMS hosted "best practices web site" 6) uses "patient centered processes of care" and 7) meets other criteria determined to be appropriate by the HHS Secretary (italics DMCB).

Readers can check out the good and the bad about ACOs for themselves, but to the DMCB, an awful lot of the ACO pilots' success will be riding on their ability to cement mutually beneficial physician-hospital relationships. The legislation apparently strives to achieve this by requiring 1) the right kind of financial arrangements (dollars that go to the docs) and 2) robust information technology (networked electronic records).

Which is why the DMCB, assuming The Reconciliation Act of 2010 survives, humbly offers up two suggestions about option of other criteria mentioned above. If it is the intent of Congress to pilot ACOs that have a good chance of success, the Secretary of HHS should give explicit preference to ACO pilots with either 1) a majority of their primary care physicians with meaningful (say, more than one year, 10% of their patients) experience in a DMAA defined disease management program, or 2) a majority of the primary care physicians with experience in a patient centered medical home demo that has been cited on the Patient Centered Primary Care Collaborative web site, or that possess NCQA PCMH recognition.

These two criteria are warranted because a track record of exposure to the 'systemness' of disease management (DM) or the PCMH can serve as a important sign that the ACO participants 'get it' when it comes to patient engagement and care management. While there may not be much in the way of research that has examined the links between DM/PCMH and ACO success, it stands to reason that having population-based care "seasoned" docs on board will increase the likelihood of achieving the outcomes and savings targets. These criteria will also increase the right kind of infrastructure, encourage experimentation with models of care that combine DM and the PCMH in usual care settings and explore that synergies between health information technology, physician incentives and state of the art population-based care management. As mentioned before, if done right, it will start where the MCCD left off.**

ACOs are the best part of this health reform package because they're one approach - if done right - that may actually "bend the curve" Even though it's tied up in Medicare's slow motion and often bumbling evaluation process as a pilot, so far, so good. The DMCB is hoping that this part of the bill remains intact in the sausage making yet to come.

* in legislative-ese, the quote is "would result in estimated spending that would be less than what spending would otherwise be estimate to be in the absence of such expansion"

** thankfully, the Senate bill's MCCD mandate appears to not be included in the Reconciliation Act

(There's lots more on Accountable Care Organizations here)

The Integration of Disease Management & the Patient Centered Medical Home

The Disease Management Care Blog has made no secret of its prediction (or maybe it's a preference, but, hey, it's my blog) that the 'patient centered medical home' and 'disease management/population health' will become integrated.

While the PCMH is many things to many people, in the opinion of the DMCB, its best features are a) the new version primary care physician and b) a team of hands-on providers. By 'new version,' it means a PCP with a commitment to chronic illness and population-based clinical and economic outcomes. By 'team of hands-on providers,' it means nurses (usually) who can help particularly ill patients navigate an increasingly complex and unending episode of care.

While disease management is the Anti-Christ to many people, in the opinion of the DMCB, it brings a remarkably sophisticated high-volume low-cost outreach/communications/coaching ability that simply cannot be matched by most primary care networks in most geographies. This seems well suited to patients with a chronic condition who need to be engaged in self care, but who do not need much hands-on care.

In order for integration to occur, three things will need to happen:

1) the PCMH pilots will go through the same cycle as DM of inconsistent findings about savings versus usual care. Think MCCD, which was more about the Medical Home. This will diminish some of the hubris and prompt recognition that a wider population reach is necessary.

2) a formula about who is "in charge" will emerge. It will reconcile the PCMH's central clinical role and DM's insurance-risk mitigation role.

3) a successful pilot/demo/clinical trial that passes muster.

The DMCB doesn't think it needs to happen in that order either.

And what does the DMCB do at times like this when it's pondering this stuff?

Why, it breaks into song! Click on the YouTube window and test drive the lyrics below. With apologies to Canned Heat.

Together we'll stand
Divided we'll fall
we need more data
the… cash flows will stall
let’s work together
Come on, come on
let’s work together
Now now people….
Because together we will stand
Every doc, all the vendors and Plans!

D M, your fees - they suck
and the.... costs still rise
n’ your …results are luck
a …roll of the dice
You can do better
You know, you know
You should do better
Ohhhh…
So says CBO and RAND,
Every blog, doc, buyer and Plan!

Ohhh, M H, you’ve got your share
there’s too much doubt
and no one cares, what
about… the docs
they want the money
they think, they think
it’s just the money
Now now people….
and the pilots may tank
you’ll be the topic of RAND!

Ahhh, come on now...
(RIFF time, dance in front of your computer)
Ahhh, come on, let's work together! (Woo hoo!)

Now…, don’t wait too long
Until it’s too late….
Let’s mix together and just integrate
It’s more efficient
the trend, the trend
the Fund’s deficient
Now now people…
Because we can’t afford
The usual for the elders of the land!

Oh well now come on you doctors
Do a group hug
With all those vendors, they are beggin for love
To work together
C’mon c’mon
please work together
Now now doctors
Because together we can share
Every fee that’ll be for Medi--care
Ahhh, yes!

(RIFF #2 time, time to dance in front of your computer again)

Because together we can care
For all those elders yes, woman and man!