How Does the Office of the National Coordinator for Health Information Technology (ONC) Think About EHR Portals?

EHR portals at work?

The Disease Management Care Blog had this thoughtful reply logged onto its "Follow-Up" post on the topic of EHR patient portals. Logged by Rebecca M Coelius MD, Medical Officer for Innovation at HHS/ONC, the DMCB recognized that this was important enough to warrant its own separate page.

While we wish that the results were more conclusive and positive, the Office of the National Coordinator for Health Information Technology (ONC) applauds the meta-analysis and the recent upswing in articles on patient portals and other patient-facing technologies. The number of patients and caregivers who desire greater participation and transparency in their healthcare makes continued research in this area vital. Yet, in a close read of the full Annals of Internal Medicine meta-analysis article and in many of the studies it cites, there were unquestionably statistically significant positive clinical outcomes, as well as positive patient experiences, associated with certain patient portal functions.

The ONC does not believe that Health IT alone is a panacea, or that meeting the form of Meaningful Use, while not embracing the new functions the technologies it enables, is likely to result in measurable improvements. The study authors caution that it was case management that tipped the utility of portals from unclear or small to more substantial, but it is important to note that the case management activities happened via the portal itself. This is a perfect example of Health IT as an enabler of new ways of reaching and caring for patients; we would not separate the two concepts.

To the study’s described limitations, we offer two significant additions. First, the definition of a patient portal remains loosely specified, so it is difficult to make conclusive statements about the entire category. The meta-analysis did attempt to list which functions were present for each study, but half of the studies that looked at patient outcomes gave only a partial description of portal features, and a deeper assessment of the quality of functions and their relevance to the outcomes measured was not present for any study.

A more illustrative future approach would be to evaluate individual functions of portals for impact on patient participation in their care and specific health outcomes, and then ask what design principles and organizational contexts were necessary to make that function successful. For example, the impressive OpenNotes project demonstrated that patients with access to provider notes had a better understanding of their health and condition, improved recall of their care plan, and increased likelihood of taking medications as prescribed. In a New England Journal of Medicine study on weight loss interventions, over twice the number of patients in the remote support intervention groups (telephone, website access, and e-mail support) lost more than 5% of their weight versus the control group. Secure messaging and the ability to view personal health information are two cornerstones of portal functionality within Meaningful Use.

Second, more than 10% of these studies are ten years old, and over a third were published five or more years ago. We understand the necessity of adequate numbers for meta-analyses, but statistical significance does not necessarily confer relevant insights. Technology, and patient preferences and capabilities for using technology have fundamentally changed over the study time periods included, not to mention the maturation among health-care organizations themselves and the expectations of patients.

The very premise of the patient portal is a rapidly ageing one. As the ONC articulated in a 2015 Health Affairs article, there are shifting attitudes related to the traditional roles of patients and providers, and exploding demand and penetration of smartphones, health and wellness apps, and connected devices. We are moving the conversation from engaging people with our existing healthcare system through “portals”, to using technology to move outside our system to reach them every day where health truly happens. What we need to measure and incentivize in the future is not the value of portals, but the value of delivering the right information and intervention to the right person, at the right time, through the right interface based on an individual user’s context.

Three Population Health Management Principles for Reconciling Quality-Based Pay for Performance and the Doctor-Patient Relationship

Writing in the New England Journal, Robert Berenson and Deborah Kay of the Urban Institute say a linchpin of Washington DC's pursuit of quality is a "policy overreach [that] could undermine the quest for higher-value health care."

Yikes.  The Disease Management Care Blog turns to population health management to ponder their unhappiness.

The authors' concern is over Medicare's "Physician Quality Reporting System" or "PQRS."  As the DMCB understands it, PQRS rewards (and penalizes) physicians for outcomes that are calculated from a set of quality "modifiers" that are submitted as part of the Medicare billing statement (an example can be found here).  The amount of money at stake is in the range of 1%-2% of the Medicare reimbursements.

Berensen and Kay point out that while the system has been ramping up over 6 years, 70% of Medicare participating physicians do not submit any modifiers.  In their opinion, that's because:

1) the loss of 1% of any payment is practically meaningless,

2) physicians distrust the metrics and

3) there is a fundamental disconnect between the modifiers and the complex world of clinical practice. 

As examples, radiologists are being dinged for total x-ray exposure while surgeons are being held accountable for pre-op antibiotic administration. While these and other quality measures are important, they fall far short of recognizing what keeps docs up at night, like reading the x-ray correctly and getting a patient through surgery and out of the hospital.

"Hear hear!" says the Disease Management Care Blog.  In the course of a normal day, it is job of doctors to do "doctor stuff" involving one patient at a time. 

But, you ask, isn't that contrary to being accountable to the health of populations? 

The DMCB doesn't think so, because state-of-the-art population health management (PHM) agrees that:

A. Physicians need to be immunized from disruptions their "customer facing" (i.e., the patient) activities.  Otherwise known as the doctor-patient relationship, that's the part of the health care system that relies on the seven or more years of undergraduate and graduate training that turns smart people into exquisitely trained physicians.  Let the doctors be doctors, says the DMCB, and let them worry about their patients.

B. High performing systems - as much as possible - need to be configured around those customer-facing activities, further enabling the doc to focus on the patient who is right here and right now. 

From time to time, PHM might have to intrude.  When it does, the DMCB suggests policymakers recognize that they should proceed:

1) only when it's really important

2) only infrequently and

3) whenever possible, when it reduces physician work by outsourcing (an example in primary care can be found here) those things that don't require the personal involvement of a doc.

It would seem that Medicare's PQRS failed to recognize the fundamentals.

Image fromWikipedia

Rising Healthcare Costs: Delayed or Defeated?

Ready, set......

According to this just-published New England Journal article, analysts are still waiting for the twin forces of 1) an improving U.S. economy and 2) higher numbers of newly insured Americans to reignite healthcare inflation.  While the latest data from the Bureau of Economic Analysis (BEA) are conflicting, data from the early part of 2015 suggests that health costs are remaining tame.

What gives?
 
While many Obamacare supporters say this is more evidence of Washington's central-planning genius, author Charles Roehrig notes other factors be at play, namely:

1. The 9 million of 2015's newly insured amounts to 3% of the U.S. population. Their baseline spending was probably half of normal, so the resulting increase would expand the nation's spending by a modest additional 1.5%.  Since this group is younger, it'll likely be less than that.  Their contribution to increasing costs will be harder to detect.

2. What's more, insurance enrollments were finalized relatively late in the year, so these newly insured haven't had much of a chance to give their new benefits an early test-drive.

3. The first quarter of 2015 was an unusually cold winter. The Population Health Blog recalls how freezing temps, wind and snow made for a relaxed day at the clinic. Multiply that across millions of newly as well as long-term insured people, and it adds up.

4. Yes, stupid, it is the economy, which has a strong correlation with healthcare spending. Loss of health insurance thanks to unemployment, declining tax revenues that pressure government insurance programs to limit eligibility as well as benefits, employers' unwillingness to go along with otherwise automatic benefit increases and a general unwillingness of consumers to open their wallets in recessionary times has also added up.

5. Thanks to the expiration of some patents, prescription drug spending moderated.

Bottom line: all of the above are one-time impacts.  The economy's impact and new access to insurance are lasting fundamentals that will not go away. It's too soon to tell what is really going on.
 
The PHB will stay tuned.

CMS Succumbs to Disease Management Style Spin?

If, thanks to the medical home or disease management, you've witnessed the improvements in patients' care, you've also probably been frustrated by those silly skeptics' insistence on validation. But for traditional research designs, statistical significance, valid comparators and publication in obscure scientific journals, the face validity of nurse-led care management for high risk patients could have ushered in a new era in primary care.

Darn those academic-actuary-statistician-weenies! And double darn CMS for falling for them and not funding the medical home and disease management!

Which is why Population Health Blog readers may enjoy this bit of peer-review schadenfreude. It appears a recent CMS pronouncement that its own "Partnership for Patients Program" prevented early elective deliveries and reduced readmissions is highly suspect, thanks to "a weak design, a lack of valid metrics, and a lack of external peer review for its evaluation." 

Yikes.

It appears the amateurs at CMS used a pre-post design, selected start and stop evaluation points to gin up the outcomes, relied on imperfect administrative data and never bothered with having its outcomes validated by independent review. As a result, we really don't know if the billion of dollars that went into PPP did any good at all.

The PHB appreciates the point. Scientific discipline and peer review go a long way making sure that consumers are getting their money's worth. Now that CMS has gone from an agnostic payer to the centerpiece of health reform, there's a huge risk that its bureaucrats will succumb to shortcuts and spin.

Taxpayers deserve better.  And so do patients.

Image from Wikipedia

17 Reasons Why Care Management Is Probably Not Going To Be in a Clinic Near You Anytime Soon

Here's a good review of all the reasons why care management has not become a routine part of patient care. 

As policymakers, reformists, consultants and architects plan for a population and outcomes-based future, they'd be wise to think about the review's 17-point reality check.

1) Start-up costs are considerable;

2) Costly to maintain;

3) Multi-year time horizon for any return on investment;

4) Any success undercuts future traditional fee-for-service revenue;

5) Can't be broken down into discreet 'reimbursible" units for fee-for-service payments;

6) It's paid for with still-novel-experimental capitated payments and/or shared savings;

7) The link between increased quality today and downstream savings tomorrow is still tenuous;

8) Complicates primary care by introducing more uncertainty;

9) Non-physician manager training is time-consuming and costly;

10) It's a resource that is best reserved for high risk patients, not all patients;

11) Doesn't fit into long-standing clinical workflows in established clinics;

12) Primary care already has enough challenges and implementing care management is not a priority;

13) Most EHRs are not configured to document or support non-physician care;

14) Decision-makers need additional information on expected net savings;

15) It relies on a lot of outside-the-doc-comfort zone behavioral, vs. "medical" health interventions;

16) It requires considerable data support;

17) It's often balkanized by multiple payers.

But be of good cheer. Jimmy Cliff reminds us that half the battle is knowing what you're up against.

The Just Right "Sweet Middle" of Care Management

Finding the "just right" middle

If you're interested in care management (definition here), there's a supportive case report in the August 7 edition of the New England Journal.

But it also makes a important point that appears to have been missed by the Editors.

The Population Health Blog explains.

The case revolves around a fragile cancer patient with abnormal blood chemistries and distributed locations of care. The author describes how care management successfully improved the patient's safety, required a lot of physician-to-physician communication and relied on care management's "reach" outside the four walls of the primary care clinic.

All good points.

However, what's also true is that prior to the cancer diagnosis, this was an otherwise well patient with post-discharge needs that were amenable to care management intervention.  In other words, this patient was "high risk, high impact." These individuals make up the narrow middle in the span of patients who range from otherwise well (destined to do OK) to disastrously complicated (destined to do poorly no matter what). 

The Population Health Blog doubts the case would have been so meaningful or successful with a routine surgery patient (stable and OK) or someone with metastatic spread of the cancer (a disaster).

The Population Health Blog is all for patient safety, doc-to-doc communication and distributed care management.  However, they're not going to be of equal benefit for every patient.  If the intent is to "save money" by reducing avoidable health care utilization, it's best aimed at the patients in the middle.

Like this one.

Insights on Delaying Obamacare's Employer Mandate: Four Potential Unintended Consequences?

Which is it?

Look at we did!

Delaying the employer mandate for one year is simply more evidence of Obamacare's unworkable complexity, says detractors.

The delay is flexibility and democracy in action, says supporters. 

The Disease Management Care Blog is troubled by how Congress and the Obama administration underestimated the complexity of the local implementation of a one-size-fits-all national health program.  It also knows that the White House needs some Affordable Care Act (ACA's) elbow room.

To gain a better understand what's going on, check out this article appearing in the New England Journal. 

Recall that the intent of the ACA was to preserve employer-based insurance while enabling individuals to access similar levels of coverage in on-line exchanges. Toss in some income-based subsidies on the upside along with IRS penalties on the downside, and the intended outcome is that millions of Americans will enter the national risk pools. That, in turn, should lead to premium drops and greater access to health care.

So what could be the impact of the delay?

First off, there's what won't happen. The authors estimate that 2015 will be business-as usual for the vast majority of persons with employer-based insurance.

But here's four things that could happen:

1. Approximately 5 million part-time workers may be closed out from access to their employer's insurance for another year. In addition, the $10 billion in government income from the $2000-per-worker) will be lost.  Both these numbers are small potatoes in a trillion-dollar enterprise involving tens of millions of workers, unless, of course, you happen to be one of those workers.

2. Millions of employed full time workers will continue to take a pass on taking the paycheck deduction for their employer-based insurance.  Whether they change their mind in 2015 will not depend on how hard their employers work to sign them up, but how aggressively the IRS pursues the individual mandate. 

3. Attached to the employer mandate were regulations that would have forced employers with a workforce of greater than 50 persons to offer competitive (read "low") insurance premiums.  Since that's also been delayed, employers and their employees who want insurance have an even greater incentive to access the on-line individual exchanges.  Employers get to reduce their insurance costs while individuals get to take advantage of those upside subsidies. The employer-employee win-win arrangement could not only undercut employer-based insurance, but "triple" the Fed's subsidy budget.

4. The DMCB's physician colleagues are not immune either.  There is emerging evidence that the individual exchanges are likely to offer "frugal" insurance plans.  Early indications are that these plans will turn to the old tricks of restricted networks and low provider reimbursement levels. This could result in millions of newly insured persons further stressing an overloaded primary care provider network.

Care Management Service Providers and the Potential of Accountable Prescribing

In previous posts, the Disease Management Care Blog has repeatedly questioned the wisdom of a one-size-fits-all, top-down, blunt force and Ver 1.0 approach to measuring health care quality.  That's why it's glad to see that the New England Journal of Medicine agrees with the DMCB in this Perspective by Nancy Morden and colleagues on the topic of Accountable Prescribing.

The authors point out that while blood pressure should be less than 140/90, LDL cholesterol less than 100 in persons with a history of heart attack and A1c should be less than 7% in persons with diabetes, it's clear that the cure can be more costly than the disease.

For many individuals with mild elevations in blood pressure, diet and exercise can be enough and, if that doesn't work, cheap water pills often work great.  Among persons with elevated cholesterol levels, inexpensive statin prescriptions can save lives. Metformin for diabetes has been around for decades and it a first line agent no matter what the A1c is.

As a result, they call for measuring and rewarding quality based on accountable prescribing that not only measures the numbers (blood pressure, blood cholesterol or diabetes control), but the percent of individuals receiving conservative or first line treatments.  While this approach would require an even more detailed databases/registries, it's within reach of most commercial insurers and advanced electronic record systems.  We owe it to our patients to provide a tailored, bottom-up, nuanced and Ver. 2. approach to measuring health care quality.

It's also a concept that the population health and care management service providers could, with the right kind of clinical partners, lead.  This calls for a pilot program and, in the DMCB's humble opinion, the sooner, the better.

For a better idea of how this might work, check out this table.

Image from Wikipedia

Credble Numbers on Obamacare: And Why is the 16.3% Prevalence of Persons Without Health Insurance Good News?

The signed Affordable Care Act

We finally have some credible numbers on what's happened to insurance enrollment under Obamacare. The paper can be found here.

The authors used the ongoing Gallup-Healthways survey that questions representative samples of the U.S. population about their health insurance status. Since it began, this repeat survey has assessed changes in the coverage of adults 18 to 64 years of age. The authors used these data to assess the trends in insurance status that were associated with the roll-out of Obamacare between January 2015 to June 2015.

For all of 2015 and the first part of 2015, the nation's uninsured rate was 20% to 21%.  Following the star-crossed open enrollment period that began in the fall of 2015, the uninsured rate began to drop.  By April of 2015, it fell to 16.3%. 

Depending on the underlying statistical assumptions, the absolute percent increase in Americans with insurance ranged between 4.2% to 7.1%. States that took the Feds up on their offer to underwrite Medicaid expansion saw a absolute decline of 6%  of low-income Americans having no insurance.

The Population Health Blog predicted that the 2015 outcomes from Obamacare would have something for everyone.  For the news outlets (like this and this) with a reputation of being sympathetic to the Administration, positive spin abounded. In the meantime, more skeptical reporters tried to poke some holes in the data, saying the increase in insurance coverage was really thanks to gains in employment or was in reality a lousy deal thanks to narrow networks.

The PHB's take?

It's struck by the relatively modest decline in the percent of uninsured Americans. Considering the heavy price we've paid, that lingering 16.3% rate is a lot.

That price?  It includes not only the hit to our national fisc, but paralyzing partisan rancor, endless and unpredictable litigation and the precedents of White House 'pen and phone' fiat by regulation. The latter will almost certainly be used by a future Presidents on both sides of the aisle.

And so it goes.

Here Comes Defined Contribution: Implications for Population Health

"Here they come!"

Regular Population Health Blog readers understand that defined benefit insurance plans provide for the future coverage of services (for example, all medically necessary treatment) or income (for example, guaranteed retirement income). 

Failure to account for increasing life expectancy, growing medical demand and technology plus an unwillingness to adequately fund tomorrow's promises with today's dollars have all fueled interest in defined contribution health insurance plans.  They provide financial support before future medical demand occurs. As a result, if the ultimate cost exceeds the available funding, it's up to the beneficiary to make up the difference.

As this timely New England Journal article points out, the defined benefit plans' days are numbered, while defined contribution plans are coming. 

Economists and conservative policymakers like their twin attributes of consumer choice and "skin in the game," while transferring risk away from government and businesses. They also like to point out that employers would be helped by freeing up dollars to hire more individuals and pay them more while also investing in their businesses.  Incidentally, this would also be one solution to the U.S. government's deficit spending.

Past attempts in Congress to translate that logic into a fix for Medicare failed faster than Obama could say "middle class." While the Republicans have proposed that Uncle Sam's rate of defined contributions exceed that of general inflation, opponents pointed out that it wouldn't keep up with medical inflation.

In the meantime, more and more employers are embarking on defined contribution plans.  And as the consumer is being forced to deal with a fixed pot of money, many are finding that they can stretch their dollars by agreeing to high deductible plans or narrow networks.  According to one survey, this is now present in close to 40% of employer-sponsored insurance.

The Population Health Blog's take:

Many of the other darlings of health care reform, such as Accountable Care Organizations (ACOs), medical homes, primary care, integrated delivery systems and population health care management providers will need to adjust to the growth of defined contribution plans with a combination of

1) providing enough value that consumers will be willing to personally pay more for their wares;

2) showing once and for all that they can provide health care for a lower price i.e., save money;

3) maintaining enough geographic or niche market dominance that they can insulate themselves from being commoditized.

A Path Toward Further Health Reform Is Lined With the IRS?

As attention has shifted to phantom IRS emails, misbehaving Iraqis and our newfound national awareness of soccer's off-side rule, it's only natural for the Population Health Blog to wonder about the status of health reform.

Enter The New England Journal with a pair of perspectives on the coming prospects for the Affordable Care Act.

Over on the left, the Brooking Institution's Henry Aaron believes that, notwithstanding ascendant Republican hopes for the 2015 elections, Mr. Obama's veto power virtually guarantees the law's survival.  The only question is whether politics will get in the way of any adjustments.  Once we're into 2015 and beyond, these could include the mandate (weaken any penalties?), Medicaid (spending caps?), the states' roles (allow for local modifications?) and changing affordability standards (increasing income-based premium support for families).

Over on the right, the American Enterprise Institute's Joe Antos agrees there is no going back.  He offers up some potential conservative modifications for 2015 and beyond, such as shifting the insurance premium support to a defined contribution basis (versus a defined benefit), shielding mainstream health insurance by moving catastrophically ill persons to "high-risk" pools and requiring insurers (including Medicare) to leverage consumer education and incentives along with provider teaming to help steer beneficiaries toward lower-cost care options.

Drs. Aaron and Antos both agree that IRS-based enforcement rules may force significant changes.  Under current law, poor persons who underestimated future income for today's premium support calculations may be subject to claw-backs. According to Dr. Aaron, the IRS is responsible for administering that, and any payment would ultimately go to the insurer long after the fact.  Dr. Antos points out that the IRS's enforcement of the mandate could lead to the spectacle of tax refunds being withheld from low-income individuals and families.

The PHB is less sanguine.  While the PHB is no political pundit, the likely increase in the number of Republicans in Congress after 2015 combined with the kick-off of the 2016 Presidential race portends more of the same health reform gridlock. 

The only good news from Aaron and Antos is that growing antipathy toward the IRS may lead Congress to uncouple the IRS and it's enforcement mechanisms from the ACA. It may not be an example of pristine bipartisanship, but if it leads to necessary modifications of the ACA, that's not necessarily a bad thing.

Stay tuned!

Image from Wikipedia

The Important Look AHEAD (Action for Health in Diabetes) Study: No Benefit from Exercise and Weight Loss in Diabetes?

Diabetes? Exercise and then die just as soon.

It makes sense, doesn't it? If persons are overweight and have diabetes, diet and exercise-based "prevention" should translate into fewer heart attacks, strokes and deaths, right?

Wrong.

It turns out that a just-published and high quality research study shows it's not so simple.  What's more, the Disease Management Care Blog brazenly suggests that the disease management/population health vendors discovered this years ago.

The just-published study is here in the prestigious New England Journal of Medicine. The DMCB suspects that, thanks to the mainstream media's fixation on Snowden, SCOTUS, and Shakira possibly hawking Obamacare, this important research may not get the front-page attention it deserves.  Considering that it was ten-year, prospective, randomized multi-center academic study involving over 5000 patients, that'd be a shame.

Here's the DMCB's summary:

Eligibility: Participants had to be between 45 and 75 years of age with adequately controlled (A1c less than 11) "type 2" diabetes, an "overweight" body mass index (BMI) of 25 or more, blood pressure less than 160/100, an ability to exercise and access to a primary care provider. 

Recruitment: This went from August of 2001 through April of 2004. It was also tailored to keep insulin-using participants to less than 30% of the study group.

Interventions That Were Compared: Participants were randomly assigned to an "intensive lifestyle intervention" study arm or a "support and education" study arm.  The intensive group received weekly group and individual counseling for six months that subsequently tapered over the subsequent duration of the study. The counseling included a 1200-1800 calorie diet plus 175 minutes of moderate physical activity per week that was aimed at achieving a weight loss of at least 7% of body weight.  The support group got only three group sessions per year. Medicines and their doses were generally left to the primary care provider.

Outcomes Studied: Participants' waist circumference, weight, blood pressure, medications and exercise tolerance were assessed once a year. Hospital and other medical records were reviewed to assess the number of deaths and cardiovascular events, such has heart attack or stroke.

The Study Population: 5,124 persons were enrolled; 2570 were randomly assigned to the intensive group while 2575 were assigned to the support group. The average age was 59 years, 60% were women, the median duration of the diabetes diagnosis was 5 years and the average body mass index was a hefty 36. Only 4% were lost to follow-up.

Outcomes:  After a median of 9.6 years of follow-up......

• patients assigned to the intensive group lost approximately three cm. from their waist and six kg. in weight vs. zero cm. and four kg., respectively, in the support group. This translated to a weight loss of 6% of body weight (vs. the target of 7%) in the intensive group vs. about 3.5% in the support group.

• the A1c, which is a test of overall blood sugar control, was about two tenths of a point (7.4% vs. 7.2%) lower (i.e. better) in the intensive group. LDL cholesterol was also lower. Better control of the diabetes meant that the persons in the intensive group were taking fewer medicines at lower doses.

• But it was all for naught.  During the course of the study, there were 403 cardiovascular deaths, non-fatal heart attacks or heart-related ("angina") hospitalizations in the intensive group, vs. 418 in the support group. The calculated rates of 1.8 vs. 1.9 events per 100 person years was too small to be statistically significant and was more likely the result of chance or randomness.

The Disease Management Care Blog's take?

The early painful lesson of the "disease management" industry was that a broad life-style intervention applied to a large group of diabetics was not going to meaningfully improve outcomes. Critics believed that while the interventions were conceptually sound (diet, exercise, weight loss), the delivery was flawed. 

This just published NEJM study would suggest the intervention itself is futile. If so, that is bad news.

"Not so fast!" says the DMCB.

In addition to renaming itself (now "population health"), the industry responded to the science and the critics by retooling.  It learned to channel tailored interventions at population sub-segments who are most likely to experience a specific benefit. Instead of an "intensive" weight loss intervention for all overweight diabetics, population health can use baseline survey, insurance or clinical data to spot (risk stratify) those diabetics who are most likely to achieve a specific benefit that could range from (for example) a sustained 7% weight loss to reduced readmissions.

This NEJM study tried to benefit all diabetics.  A better approach is to find which diabetics will benefit.

As an aside there were some other issues with the study to bring up when debating the study with colleagues and foes:

The BMI of 36 suggests this was a very obese study population that lost only 6% of their body weight during the course of the study.  Since weight was still a health risk at the end of the study, the DMCB wonders if the intervention would have shown more benefit with a less heavy population.

The support group also lost weight and lowered their A1c, which could have obscured the clinically significant benefit in the intervention group. 

This accompanying editorial points out that lower statin and ACE drug use in the intervention group could have paradoxically increased their risk, since these drugs are known to lower the incidence of stroke and heart attack.

The editorial also points out that spin-off studies have already shown that the intervention group benefitted from higher quality of life.

Sure, Accountable Care Organizations ACOs Can Save Money, But Can They MAKE Money?

ACOs at work.

According to this Bloomberg news release, some of Medicare's Accountable Care Organizations (ACOs) are already achieving cost savings. Mt. Sinai and Coastal Carolina are reducing emergency room visits while Hackensack is reducing costs.

All three institutions are using two key ingredients:

1) information technology-based risk stratification to identify the persons at greatest risk and

 2) dedicated full-time nurses who perform telephonic and in-person outreach, coordinate care and provide patient coaching that, in turn, is tailored to that risk.

To the DMCB, the good news is that ACOs are using the two approaches that define modern-day disease and population health management. That industry's success will be Mt Sinai's, Coastal Carolina's and Hackensack's success.

The bad news is that the news release only addresses half the question: did any savings exceed the institutions' cost of the risk stratification and the nurse-FTEs? If the early answer is no, then avoided ER visits and reduced costs could turn out to be much like Governor Christie's lap band: so far so good but it's still risky and could ultimately be all for naught.

And on an unrelated note, this just-published New England Journal article makes note of "not made in America" health care innovations from overseas that could hold important lessons for the United States. In particular, the authors point out that Germany's DRG hospital payment system includes 30-days of post-discharge care and includes the physician payment. Readmissions within that 30 day window are, with a few exceptions, not covered and physician payment is possible because docs are often employees of the hospitals.

"Interesting!" says the DMCB, but is reminded that Germany is hardly a model for reducing inflationary cost trends.   It also specifically recalls hearing Germany's Minister of Health, Daniel Bahr, express impatience with his country's DRG system just last week. He criticized it for not advancing enough quality in his keynote address at the HauptKongress in Berlin.

More Big Insights on Big Data

Given the data, what are her chances of
getting breast cancer?

Unable to sate its big appetite for big data insights, the Population Health Blog glommed onto the New England Journal's just-published article on "Learning from Big Data."

As noted previously, "big data" is the use of statistical associations ("predictors") in a) large and b) disparate data sets  to gain insights at the individual level ("outcomes"). For example, a physician could know the likelihood - based on demographic, clinical and economic inputs - that a particular patient won't fill a prescription. As an other example, the PHB spouse could know the likelihood - based on prior active-passive behaviors, incentives and maternal upbringing - the likelihood, despite numerous reminders, that her husband will "forget" to take out the trash.

It's important to recall that big data is not about causality. Just because living in a certain zip code is an independent predictor of obesity (for example) doesn't mean living in [insert name of town] causes residents to be fat. Big data is "agnostic" about the cause, but that doesn't mean Big Data Architects (BDAs) can't use the information.

According to the author, the road from the promise to the reality of big data will be lined with:

1. generalizability, or being confident that the populations used in big data studies are similar to the populations where their lessons are being applied. Propensity matching or scoring is a good step in that direction;

2. automation, so that multiple questions can be answered simultaneously by many users;

3. "data refreshes," so that associations can be retested on repeated basis as new data come on line;

4. ease-of-use, so that even an orthopedist could use the software and understand the outputs.*

Politically, we'll also need to get

5. the owners of data warehouses - including the electronic health record vendors and insurers - to agree on either a) common data formats or b) methods that allow for the interpretation of data regardless of the format. An example of the latter the use of an order, entry or insurance claim for supplemental oxygen therapy as a marker of poor health status.

6) a resolution of our absolutist privacy "impasse.""De-identification" of patients' information makes it possible, but never guaranteed, to keep personal health information secure.

*okay, the New England Journal author didn't poke fun at the orthopedists by saying that, but the PHB couldn't resist. By the way, one way to do this would be to have the outputs be in pictures.

Image from Wikipedia

Maintenance of Certification in Internal Medicine: What the Population Health Community Needs to Know

Since population health provider organizations work closely with physicians, they're aware that "board certification" is an important credential.  Being "boarded" in family practice, pediatrics or internal medicine is widely regarded as evidence of extensive training.

They may not be aware of the controversy brewing over board certification in the internal medicine physician community.

The American Board of Internal Medicine (ABIM) is the certifying Board for the nation's internists.  After meeting training requirements involving years of training after medical school graduation, candidates have to pass an examination.  Once physicians do that, they have the credential that documents their expertise. 

It used to be that once you did the training and passed the test, you were credentialed as a "board certified" internist.... forever.  With increasing recognition that skills can grow stale with time, in 1990 the ABIM decided to require recredentialing on a periodic basis. 

That process has evolved under the umbrella term "maintenance of certification" ("MOC").  You can read more about that here and here, but it basically involves earning "points" through activities such as documentation of learning, participation in quality improvement, chart audits and taking a repeat test.

Unfortunately, MOC and the ABIM have become a focus of physician ire.  While the academics and organized medical societies' leaders believe in the process, many rank and file practicing physicians disagree. 

Among their concerns that are nicely documented here and here:

1. It takes a considerable amount of time, documentation, and paperwork to complete the 10 years' worth of continued training/chart audits and to prepare for the repeat examination.  (That's especially true thanks to the difficulty at extracting electronic records data; it also puts smaller practices at a disadvantage, since they may not have the support personnel to help with all those tasks).

2. It's also expensive.

3. If a physician doesn't pass the test, it needs to be taken again at additional cost.  Over the past five years, the failure rate has increased from 10% to 22%.  Since it's unlikely that the pool of docs entering the MOC process are dumber, that suggests the test is getting unnecessarily harder. Some physicians wonder if ABIM has a financial incentive to increase the failure rate. 

4. Unlike the initial process of board certification, there is little hard evidence that MOC-credentialed physicians  attain better patient outcomes compared to non-MOC physicians.

5. Physicians are unhappy that the MOC process does not recognize the practical wisdom that comes with decades of patient care.  It is "one size fits all" and can't be tailored to account for different practice settings.

6. There is a possibility that MOC could evolve from a voluntary exercise in professionalism to a mandatory condition of licensure, hospital/insurer participation or employment.

7. ABIM not only has a monopoly, it has no oversight. Whatever the merits, the ABIM's MOC actions are seen by some as capricious, arbitrary, disconnected to the real world and only adding to physicians' low morale.  One survey suggests a majority of practicing physicians are skeptical about the MOC.

 The Population Health Blog suspects this is a controversy that is not going away anytime soon.  Population health service providers will always be interested in helping their "orphan" patients without a PCP become engaged with a physician, and may use "board" status as one criterion for referral.  It remains to be seen if "MOC" participation should be part of that calculus.

Stay tuned!

The Hospital Readmissions Reduction Program: Cautions and Caveats

"Maybe you should go
back to the hospital!"

Ask most wonks - especially ones who never took care of a patient - about "readmissions," and, after quoting this article, these health policy Urkels will tell you that returning to a hospital is the poster-child of all that ails U.S. medical care. Providers who can't get it right the first time, they say, are not only giving slipshod care, but are double dipping because their mistakes generate even more fat fees the second time around.

"Balderdash!" says the Disease Management Care Blog. Many Medicare inpatients are so sick that it's a miracle that they get to go home in the first place.  Keeping patients in the hospital can be more life-threatening than the home environment and, when things don't get well after a discharge, it's often more a function of social support than medical skill. 

That doesn't mean that CMS is going to listen to docs and back off of its Hospital Readmissions Reduction Program (HRRP). Using risk-adjusted actuarial projections, every U.S. hospital will be prone to a possible payment reduction if their observed rate of readmissions for heart attack, heart failure, and pneumonia exceeds the expected rate. Based on those projections, approximately two thirds of hospitals could be penalized.

Writing in the New England Journal of Medicine, Karen Joynt and Ashish Jha point out that hospitals are concerned because 1) readmissions fall outside of their control and 2) the actuarial projections are imperfect.  As a result, hospitals that care for the most fragile and socioeconomically disadvantaged are at risk for paying more than their fair share of CMS's $280 million claw-back penalty. 

The NEJM authors recommend three modifications to CMS' HRRP:

1. Include patients' socioeconomic status in any risk adjustment modeling. One easy-to-obtain modifier, for example, could be whether the patient is on Supplemental Security Income.  Patients on SSI are less able to cope, which is why they quality for the program in the first place.

2. Include hospitals' mortality rates in any risk adjustment modeling.  Hospitals with special expertise are less likely to have borderline patients die on their inpatient services, which means they'll have their more than their fair share of fragile survivors.

3. Limit the penalty to readmissions that occur within hours or days of a discharge, instead of the current problematic policy of counting any readmission that occurs within 30 days.  It makes sense to believe that a premature discharge or slipshod discharge planning is at fault if the patient returns within 3 days instead of three weeks.

Since it's unlikely that HRRP program is going away, the DMCB agrees with the three recommendations.  In the meantime, it also suggests:

1. CMS should be held accountable by Congress to execute well on the program,

2) Claims analytics - possibly using a "Big Data" approach - should be applied to Medicare claims to examine whether hospitals are turning to two potential options to undermine the program:

a) gaming the system by altering how they "code" the billing for their readmission patients, or

b) accepting the penalty because of favorable income from readmissions.

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Obesity Surgery in Diabetes Mellitus: A Three Year Trial Shows High "Cure Rates." The Implications for Population Health

In case there is any doubt about the long-term efficacy of obesity surgery for diabetes, check out this three year study that was just published by the New England Journal of Medicine. 150 persons between the ages of 20 and 60 years with an A1c greater than the recommended target of 7% and a BMI greater than 27 were randomly assigned to either gastric bypass, sleeve gastrectomy or intensive medical therapy. 8 persons dropped out after being assigned to medical therapy and one patient had their surgery cancelled. Over the next 3 years, 4 persons were lost to follow up.

Of the remaining participants, two thirds were women and three quarters were white. The mean age was 48 years, the average BMI was a prodigious 36 and the mean A1c was a poor 9.3%, with an average duration of diabetes of just over 8 years. 

Of the 40 medical patients, 5% ended up with an A1c of 6%, versus 38% of the 48 bypass and 24% of the 49 sleeve patients.  The average weight loss was 4.3 kg in the medical patients vs. 26 and 21 kg in the bypass and sleeve patients. While only 2% of medically treated patients were able to stop their diabetes medications, 69% and 43% of the bypass and sleeve patients were able to do so. Only four patients in the surgery groups required additional surgery for the treatment of complications.  None died.

The Population Health Blog finds the results compelling enough to believe that the surgical option for obesity-related diabetes mellitus may be turning out to be a first line option.  The complication rate is acceptably low and the "cure" rate of up to 70% (if defined as not having to take medications) is likely to be welcomed by patients facing a lifetime of otherwise chronic illness.

Criticisms?

Critics may worry that any long-term economic benefits at a population-based level may be cancelled by the cost of surgery.  The PHB understands that, but doesn't believe that obesity surgery should be viewed through a "return-on-investment" lens.  Rather, the value assessment of "outcome" (in terms of diabetes and obesity cure) per unit of cost (dollars spent) is a as good as an investment compared to, say, coronary artery bypass grafting or a knee replacement.

Critics may also worry that obesity surgery is more of a symptom of an overfed society and that our national treasure would be better spent on understanding our dietary dysfunctions.  The Population Health Blog cannot disagree, but doubts that our national health spending can be wired so that every dollar spent on the promotion of nutritional wisdom will reduce the near-term health care cost crisis from diabetes.  We need to be prepared to invest in both.

Implications for Population Health

It appears to the PHB that this was a single site "efficacy" study involving an academic medical center.  We don't know if the low complication rate observed here is typical of other hospitals that offer obesity surgery.  In addition, this study did not examine the impact of the more popular approach of banding surgery.  That being said, this three year trial suggests that bariatric surgery should be offered in the suite of options for persons meeting the criteria above.

The good news is that shared decision making has already been evaluated in this setting.  While the majority of participants are more likely to chose conservative treatment, the point is that a 40-70% chance of cure over three years should be raised in the course of patient-centric coaching.  Population health vendors in the diabetes-obesity "space" should be prepared to engage patients on this treatment option and help them decide if surgery is the right choice for them.

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How Can Care Management Programs Manage Physician Incentives?

One ingredient for physician cooperation?

Years ago, when the Disease Management Care Blog was helping to lead a care management program, it was paired up with a nurse-administrator who was troubled by the notion that docs should get paid to sign-off on a disease management care plan. Why, it was asked, should docs get any extra compensation to do something that's a fundamental part of caring for patients?

It listened politely to its colleague's input.  After a careful review of all the issues, risks, benefits and alternatives, the physician-DMCB decided to compromise by paying the docs to sign-off on the care plans.

Drs. Nikola Biller-Andorno and Thomas H. Lee, writing in the March 14 New England Journal, point out that that physician enticements are far more complicated than shekels for signatures. They think economic incentives in health care are a complex mix of "traditional," (social status) "self-interest, (one example is money) "affective" (being appreciated) and "shared purpose" (for the greater good) motives.  They also suggest that they are unavoidable.

A nurse care management administrator might as well join 'em rather than fight 'em.

Armed with that insight, it's easier to contrast the underlying cultures of a non-for-profit community health center versus a for-profit hospital chain. It's also easier to understand that performance measures can not only appeal to self-interest (as in pay for performance) but to the "affective" reward of being given an excellent rating by a community of colleagues.  The authors also point out that a sense of shared purpose cannot be underestimated, since it speaks to the "core principles of the medical profession."

The DMCB's insight here is that there is no single incentive "lever" that can change physician behavior.  Rather, the best approach to incentives is to capitalize on all four incentive domains.  What's more, if "shared purpose" is undervalued, physicians are more likely to feel dissed and ignore the best laid incentive plan.

It turns out paying the docs was the right thing to do as well as appealing to their sense of shared purpose.  What the DMCB and nurse administrator should have done was to also look for some way to leverage the other domains of social status (perhaps a recognition program) and being appreciated (asking a lead physician to express appreciation for the extra work.

Image from Wikipedia

"Opt-Out" Health Insurance Enrollment

Say no to your health insurance?

Kudos to the New England Journal for providing a tidy summary of the latest Republican healthcare reform proposal. Up until now, the Population Health/Disease Management Care Blog was only vaguely aware of the GOP's evolution from the political party of "no" to one of "go," albeit with lots of caveats. 

It seems the Senate Republicans no longer want to repeal Obamacare and are OK with keeping many of its more popular reforms.  Instead, they're focusing on undoing selected provisions, such as repealing the minimum benefit, returning some aspects of medical underwriting and resurrecting the "block grants" for Medicaid.

But one of the more interesting wrinkles in the proposal is "auto-enrollment."

Those of us from the bygone days of "disease management" may recall the debates over the merits of "opt-in" versus "opt out" participation in our programs.  The former required persons to actively chose to be entered into nurse coaching, which had the advantage of committing resources to a highly motivated population.  The latter approach assumed all patients with a condition were enrolled and, only if they specifically requested it, would they allowed to stop the coaching phone calls.  Unfortunately, "opt-out" usually gathered many patients who never answered the phone and were "engaged" in name only.

Well, the Republicans are apparently proposing that states be allowed to "auto-enroll" persons eligible for premium payment support into an insurance plan or Medicaid without their up-front permission, just like the old "opt-out" disease management days.  The tax credit would cover the insurance costs, no bills would be issued to the consumer and voilà! the risk pools would expand.  Patient choice would be preserved, because persons could always just say no.

The DMCB was always of fan of opt-in disease management.  Not only were patients who wanted to be in the program more amenable to behavior change, it allowed the program to "flex" the nurses that we needed as the program grew in scope.  However, when it comes to insurance, the DMCB thinks the Republicans may be onto something with their opt-out insurance approach.

Count it as a fan.

Latest Mediterranean Diet Study Results: Much Ado About Nothing

Olive oil

Fearing that it would have to write about the Oscar award show's vulgar Hollywood humor or Washington's budgetary caterwauling, the Disease Management Care Blog was happily distracted by a flurry of splashy news reports on a just-published primary prevention trial:

"Mediterranean diet....showed 30% lower risk of having a heart attack, stroke or dying of heart disease....."

"Tasty diet cuts heart disease, study finds."

" ....diet rich in olive oil, nuts, beans, fish, fruits and vegetables prevents about 30% of heart attacks, strokes and deaths from heart disease..."

Fighting the urge to run to the pantry and add years to its life by ingesting some olive oil-drizzled walnuts, the DMCB did something that mainstream news reporters seem incapable of doing: it asked what the diet actually entails and whether the impact was really all that.

Here's the original New England Journal of Medicine study. Disappointingly, the absolute risk reduction was quite small and, for the typical DMCB primary care patient, would involve a major lifestyle change.

The DMCB explains.

The PREDIMED trial ("Prevención con Dieta Mediterránea") was a prospective and randomized clinical trial in which male (age 55 to 80 years) and female (age 60 to 80 years) volunteers with either:

1) diabetes or

2) three other risk factors, such as tobacco use, high blood pressure, abnormal cholesterol levels, obesity and a worrisome family history of premature heart disease,

were randomly assigned to one of three treatment arms:

1) A "Mediterranean diet" supplemented with extra-virgin olive oil (a liter was delivered to the home each week), or

2) A "Mediterranean diet" supplemented with nuts (30 grams of almonds, walnuts and hazelnuts per day) or

3) A control diet.

What's just what is a Mediterranean diet?  According to the authors:

A) lots of olive oil for cooking and dressing dishes;

B) consumption of ≥ 2 daily servings of vegetables (at least one of them as fresh vegetables in a salad), discounting side dishes;

C) ≥ 2-3 daily servings of fresh fruits (including natural juices);

D) ≥ 3 weekly servings of "legumes" (kidney beans, pinto beans, black beans, chickpeas, lima beans, black-eyed peas, split peas, and lentils);

E) ≥ 3 weekly servings of fish or seafood (at least one serving of fatty fish);

F) ≥ 1 weekly serving of nuts or seeds;

G) selecting white meats (poultry without skin or rabbit) instead of red meats or processed meats such as burgers and sausages;

H) cooking regularly (at least twice a week) with tomato, garlic and onion adding or not other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or not aromatic herbs. This sauce is made by slowly simmering the minced ingredients with abundant olive oil.

I) the limitation of cream, butter,margarine, cold meat, pate, duck, carbonated and/or sugared beverages, pastries, industrial bakery products (such as cakes, donuts, or cookies), industrial desserts (puddings, custard), French fries or potato chips, and out-of-home pre-cooked cakes and sweets.

By the way, the study organizers used genuine olive oil, not this fake stuff.

Patients assigned to the diet had to see a dietitian at the outset of the study and participate in every 3 month group education sessions.  There were no recommendations to lose weight or participate in exercise.

The results?

8713 persons were screened and 7447 were assigned to one of the study arms.  After a median of 4.8 years, 523 persons were lost to follow-up. 288 persons had either a heart attack, stroke or
cardiovascular death.  There were 96 deaths in the extra virgin olive oil group, 83 in the nut group and 109 in the control group. The calculated percents were 3.8%, 3.4% and 4.4%, respectively.  Versus the control group that's an absolute difference of 0.6% and 1.0%. There didn't appear to be any surprises in the subgroups' outcomes.

Using a number needed to treat analysis, these data basically mean 100 to 166 persons would need to live on fish, nuts, lima beans, and olive oil without burgers, starches or soda for 5 years to prevent a single heart attack, stroke or death.

The DMCB's take:

1. The small amount of benefit is not enough, in the DMCB's estimation, to warrant routine inclusion of a "Mediterranean diet" in disease management care planning for persons with diabetes or multiple cardiac risk factors.

2. The diet was "all or none."  There is no evidence, based on this trial, that substituting crab cakes for that steak once a week and using olive oil on your iceberg lettuce tonight will help you live longer.

3. The "number needed to treat" of 100-166 over 5 years is in the same performance range as statin drugs with a NNT that, according to this study, ranges from 77 to 150 over four years.  No wonder many persons choose to continue with their more tasty burgers and fries along with a daily pill.

4. It's unlikely that persons who are not already on a Mediterranean diet will chose to switch, and given the amount of sacrifice involved and the small reduction in risk, the DMCB can't blame them.

Image from Wikipedia