Whither Obamacare, Now That "It's the Law of the Land?"

While a roll-back of Obamacare now is about as likely as spotting gargoyle statuettes among the DMCB spouse's holiday decor, a recent New England Journal article points out that the Affordable Care Act (ACA) - even if it is the law of the land - still has a very bumpy road ahead.

That's because of four key issues:

1. The States can still knot things up by forcing Washington DC to run the Health Insurance Exchanges (HIEs).  It's very possible that Uncle Sam won't pull them off on time and, what's more, there's a credible Supreme Court challenge looming over Obamacare's potential lapse in extending tax credits to the federally-run HIEs.

2. States can refuse the Medicaid expansion. While their statewide hospital associations are very  unhappy about that, Governors are either ideologically opposed or just plain wary of additional downstream costs. This could result in additional millions of uninsured, especially in the conservative "red" states.

3. Health care cost inflation is likely continue its upward spiral.  Congress, no matter how CMS' payment innovations turn out and no matter how much it wants to curtail costs, is unlikely to withstand the lobbying from all corners of medical-industrial complex involving thousands of pages of rules and regulations.

4. Deep public ambivalence about the law will continue. That means that as Congress and the President look for ways to control the Federal deficit, Obamacare is especially vulnerable. Unlike Social Security or Medicare, the ACA's "patchwork" of insurance reforms is headed toward the fiscal cliff without a strong supportive constituency. Before Congress even touches Medicare, it's far more likely to cut Obamacare. The first hit could be those insurance tax subsidies mentioned above.

Another Study Shows Disease Management Works

Here's more evidence that disease management really works.

The study, Online Disease Management of Diabetes: Engaging and Motivating Patients Online With Enhanced Resources-Diabetes (EMPOWER-D), was a prospective randomized clinical trial that is posted online over at JAMIA.

The Disease Management Care Blog summary:

Researchers at the Palo Alto Medical Foundation used the electronic health record (EHR) to look for active (seen once in the last 12 months) patients over 18 years of age with  Type 2 diabetes and an A1c greater than 7.5%.  If the primary physician approved, patients were then asked to complete a questionnaire and keep an appointment with a research assistant for additional review and discussion. Once patients agreed, they were entered into the study.

6,907 potential study subjects were identified, 1,594 agreed to complete the questionnaire and see the research assistant, 768 met additional research criteria. 415 agreed to be enrolled in the study, and 379 completed most of the 12 months of follow-up.

Patients were randomly allocated into one of two treatment tracks and followed for 6 and 12 months. The usual care (UC) track provided reminders about preventive care in addition to their usual visits with their physicians.  The intervention (INT) track had the usual physician visits, plus:

1. access to a "nurse care manager" (NCM) who provided advice and protocol-based medication changes,
2. Wireless uploads of glucometer readings into the EHR,
3. an EHR-based patient-specific summary "dashboard," that included risk scores, preventive care updates and a care plan,
4. web-based insulin, exercise & nutrition logs,
5. secure EHR-based messaging with the physician and NCMs and
6. patient-specific text and video offerings targeted by the NCMs.

The principal outcome measure was the A1c test, which is an indicator of overall blood glucose control. A level of 7 or lower is considered to be satisfactory control. At 6 months, INT patients statistically significantly decreased their A1c by 1.3 vs. 0.7 in the UC group.

At 12 months, there was still a difference favoring the INT group, but it did not achieve statistical significance: 1.1 vs. 0.7. 

Once the study was completed, the authors went back and looked at the proportion of patients that had decreased their A1c by at least 0.5.  At 6 months, it was 70% vs. 53% for  at 6 months, and 70% vs. 55% at 12 months for the INT and UC groups, respectively.  Both differences were statistically significant. 

Patients in the INT group were also more likely to lower their cholesterol, go through a medication adjustment, experience lower "treatment distress," have greater knowledge of their diabetes and be more satisfied with their care.  There was no difference in blood pressure control or the number of physician visits.  Overall health care costs or insurance claims expense were not measured.

Disease Management Care Blog take-aways:

You Want Evidence? Thanks to this high quality randomized controlled clinical trial conducted in a real world setting, the evidence base supporting the use of remotely placed nurse care managers continues to build.   Kudos to Palo Alto for simultaneously taking good care of their patients and conducting impressive research.

Patients At Risk: The combination of a) a steady percent of INT patients keeping their A1c 0.5 at 6 and 12 months plus b) a simultaneous overall average decline in the A1c makes the DMCB think that there was a subcohort of patients that "back-slid" and affected the group mean.  Commercial population health management service providers are working hard at prospectively identifying these higher-risk individuals for additional interventions.

Doing something is better than nothing: While the modest A1c decrease in the UC patients could have been due to regression to the mean, the DMCB wonders if they also benefited from being identified and monitored. 

Can Finally Point to Something Good About the EHR: While the EHR continues to disappoint in terms of consistently improving quality or reducing costs, this study demonstrates an important upside: it can be used to efficiently recruit potential research subjects.  That's important because thousands of candidate patients are needed to find hundreds of study participants
 
Physician Utilization Did Not Decline: Unfortunately, this study did not address multiple measures of utilization, so the DMCB doesn't know what to make of any decrease in potential costs versus the cost of the the program.

ACOs Take Note: While the Palo Alto System is not representative of most health care settings in the U.S., it does hold important lessons for Accountable Care Organizations. Given their contractual responsibility to improve diabetes quality as well as managed insurance risk, this study says they ignore the potential of remotely-based and technology-backed nurse care managers at their peril

More on Al Lewis' Book "Why No One Believes the Numbers"

Remember the DMCB's reviews (here and here) of Al Lewis' book Why No One Believes the Numbers?  The DMCB can't either, which is why you may want to check out this review by Christobel Selecky over at the excellent DMCB sister blog, The Doctor Weighs In.  It's worthwhile reading, especially since Ms. Selecky was the CEO of the star crossed disease management company LifeMasters. She knows of what she speaks and has the scars to prove it.

The DMCB finds her 6th paragraph slightly off topic but worthy of further discussion. Say what you like about the "evidence" supporting disease management, but let's at least be consistent and apply the same high standard to the patient centered medical home, the electronic health record and accountable care organizations.  Patients deserve nothing less.

A One-Size-Fits-All Approach to Determining Clinical Effectiveness Versus Shared Decision Making

The Disease Management Care Blog recently attended a physician meeting that keynoted a U.S. Senator.  In his prepared comments, he admitted that he knew little about controlling health care costs.  Unfortunately, that didn't stop him from humbly paraphrasing the testimony of a famous economist:

"Find out what works," said the expert, "and do that."

Maybe some of the physicians' silence that followed was an "aha!" reaction to the Senator's insightful nostrum.  Some of it may have also been out of respect. 

The DMCB is sure, however, that most of the docs in the room were quietly thinking "You must be kidding me."

Such is the approach of the mandarins leading our federal health care institutions.  "Science and existing literature" says HHS Secretary Sebelius.  "Effectiveness" is the mantra of the Center for Medicare and Medicaid Innovation.  "Improving health care" is now part and parcel of CMS. 

Unfortunately, applying scientific evidence to the economics of health care delivery sounds easy enough until you get down into the weeds.  For a perfect example of that, consider the common condition of painful spinal stenosis among Medicare beneficiaries. According to this JAMA article, there were over 37,000 operations in this population at a national cost of $1.65 billion. 

Which begs the question: does spinal surgery "work," is "effective" and "improves health care?" Can the "science and existing literature" help us decide?

To get an idea of just how complicated the answer is, check out this Agency for Healthcare Research and Quality (AHRQ) research review on Spinal Fusion for Treating Painful Lumbar Degenerated Discs or Joints.  The conclusions from the abstract are:

Overall, limited evidence suggests that spinal fusion compared with physical therapy improves pain and function for adults undergoing fusion for low back pain due to disc degeneration. Because of insufficient reporting and variation in surgical methods used in the different studies, the incidence of adverse events (serious and minor) associated with fusion could not be determined conclusively. The evidence was insufficient to draw evidence-based conclusions for the benefits and harms of spinal fusion for patients with degenerative stenosis or degenerative spondylolisthesis of the lumbar spine. The evidence was also largely insufficient to draw conclusions about the benefits and harms of fusion compared with other invasive treatments or different fusion approaches or techniques.

In other words, there is some evidence that, compared to conservative treatment, surgery helps.  After that, it's the stuff of caveats, statistics, evolving technique and myriad study limitations.

In fact, it's so complicated that the only way it can be applied is by helping patients understand how the science applies to their unique circumstances and values.  Once the patient understands things, it's a matter of letting that patient and doctor jointly decide on the best course of action.

That approach - in contrast to U.S. Senators musing on how we need a one-size-fits-all approach to what works - is called shared decision making and it can be applied to back surgery with considerable cost savings.

"What works?" asks the Senator?  The answer is for you to consider staying out of the way.

The Electronic Health Record (EHR) On-Line Portal Increases Hospitalization Rates



"Hi doc! I used my on-line
portal to make an appointment!"

Hey there Accountable Care Organization executive.

You're probably willing to continue to commit millions of dollars toward an electronic health record (EHR) coupled to an online patient portal.  That's because you've been told by your leadership team that electronic consumer empowerment, patient-provider communication and the substitution of efficient two-way messaging for costly face-to-face visits will increase quality, reduce expenses, generate shared savings and guarantee that your life-sized portrait will be prominently displayed in your flagship hospital's lobby.

Well, after you've read a just-published JAMA research study by Ted Palen, Colleen Ross, David Powers and Stanley Xu, you may want to tell your administrative assistant to cancel that appointment with the portrait artist.

The article's title is Association of Online Patient Access to Clinicians and Medical Records With Use of Clinical Services.

How the study was done:

Kaiser Permanente Colorado added "MyHealthManager" (MHM) to their EHR in May 2006. MHM allows patients to view tests, records, problem lists as well as care plans, schedule appointments, request refills and message their doctors. By June of 2009, over 375,000 Kaiser patients had signed up for MHM. Of those, about 45% had used the system at least once.  Of this number, Kaiser researchers pulled the records of 44,321 persons who had been continuously enrolled in the Kaiser system for at least two years. 

This group was retrospectively matched to a control group of Kaiser patients who had not signed up for MHM.  The authors did this through "propensity matching." This found a similar number of patients, based on age, gender, race, number of chronic illnesses and baseline office visits who, using logistic regression analytics, appeared to be the type of patient who would otherwise sign up for MHM.

The results:

Compared to non-MHM patients, the MHM experienced an increase in hospitalization rates (20 per thousand patients) and emergency room visits (11 per thousand).  In other words, for every hundred patients, the on-line portal seemed to lead to 2 extra hospitalizations and 1 extra ER visit. Both differences were statistically significant.

There were also increases in the number of office visits (.7 per patient per year), telephone calls (.3 per patient per year) and after-hour clinic visits (18.7 per thousand patients per year).

Caveats:

The authors correctly point out that this study is not perfect.  Retrospective propensity matching is not as good as a randomized clinical trial; it's possible that the patients who self-selected for MHM were already realtively more interested in or likely to increase their use of health care services.  Results at Kaiser may not apply elsewhere.

Implications:

Despite the limitations, this study should be a wake-up call for those who believe EHR portals is a savings panacea.  By increasing access to on-line services, physicians and patients may paradoxically use the system to address concerns that otherwise wouldn't come to medical attention.  In other words, the EHR portal exacerbates the classic health care economics problem of supplier-induced demand.

Image from Wikipedia

March of Dimes Says the PREEMIE Act Saves Lives. Does It?

Saving children's lives. Nothing could be nobler right?

According to a November 15 March of Dimes press release:

“The PREEMIE Reauthorization Act will save infants’ lives," said Dr. Jennifer L. Howse, President of the March of Dimes. “Tonight the Senate took a vital step toward ensuring a healthy start for our nation’s infants."

The release goes on to say:

“Our efforts are bearing fruit,” Dr. Howse added. “Preterm birth rates have now dropped for five consecutive years after rising steadily for three decades. The PREEMIE Reauthorization Act will continue to fuel our progress by supporting federal research and promoting known interventions and community initiatives."

"Really?" asks the Disease Management Care Blog.  What about the dozens of lecturers, professors and colleagues that have told the DMCB that preterm birth rates have remained stubbornly unchanged for decades? 

It's a significant problem because the delivery of a child prior to 37 weeks gestation (vs. the usual 39 weeks) is associated with many complications for both the mother and child.

Wanting to learn more about this life-saving legislative miracle courtesy of Uncle Sam, the DMCB decided to take a look for itself.

It turns out the original "Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act" (or PREEMIE) Act was passed and signed into law by then President Bush in 2006.  The statute provided for a number of interventions, including millions of dollars worth of research funding, provider education and nationwide monitoring. The funding was due to run out in 2011. 

Enter the PREEMIE Reauthorization Act that was just passed by the U.S. Senate.  It doesn't appear to authorize any funding, but it essentially continues the activities contained in the original 2006 legislation by striking out the term "2011" and replacing it with "2017."

Based on the March of Dimes press release quotes above, it appears that the organization is crediting the 2006 PREEMIE with the nationwide drop in preterm birth rates. The basis for this is March of Dimes data that can be found here. If you look at the upper right hand corner, you can see that the prematurity rate went from 12.8% in 2006 (when the law was passed) to a preliminary measure of 11.7% in 2011.

Unfortunately, these data do not tell the entire story. For that, the DMCB went to the "childstats.gov" website and discovered that overall prematurity rates have remained stubbornly fixed in the 10.6% to 12.8% range for over two decades.  The rate peaked in 2006 and has been drifting back down to the baseline historical average.   To the DMCB it looks like normal year-to-year variation.  What's more, DMCB readers are well aware of the phenomenon of regression to the mean.

Next step for PREEMIE is the House of Representatives.  The DMCB isn't advocating for or against PREEMIE, but it hopes a second look in our bicameral legislative process prompts a more rigorous and complete examination of the outcomes associated with this piece of legislation.

Editorial Comment: The DMCB is all for research to discover what works, but it would like to point out that there is a considerable body of published literature on the topic.  Do we really need more research, or do we need to figure out how to provide these services using the principles of population health management? 

You be the judge: it's your money.  

Image from Wikipedia.

The Latest Cavalcade of Risk Is Up

.... and it's been up for a while.  The tardy DMCB was mentioned in Louse Norris' excellent rendition of the Cav back on November 14.  Even now, however, the Colorado Health Insurer Insider page is still worth a visit for anyone interested in the some great writing on the economics of enterprise, business and insurance risk.

Enjoy!

Patient "Skin in the Game" Has Its Limits: The Assymetry of Patient Cost-Sharing Incentives

The Disease Management Care Blog always thought that the upsides and downsides of patient "skin in the game" was "symmetrical."  Writing in the Oct 24 issue of JAMA, Kevin Volpp and colleagues point out that that may not be true and that patient economic incentives may not necessarily work as intended when it comes to Choosing Wisely. 

Rather, economic incentives can be asymmetrical.

In other words, it's commonly thought that if increasing patient out-of-pocket cost for a drug (for e.g., an unproven brand-name drug) or unnecessary health care service (for e.g., antibiotics for uncomplicated sinusitis) decreases utilization in a population by a certain amount, it should stand to reason that decreasing the cost (for e.g., for a cholesterol drug) by the same amount would correspondingly increase utilization (for e.g., among heart attack patients). 
 
According to Dr. Volpp and colleagues, it doesn't work out that way.  Research has shown that increasing out-of-pocket costs can readily prompt patients to defer testing or treatment.  However, the converse is less true: decreasing out of pocket costs has limited impact on incenting patients to embrace testing or treatment.

Reasons include:

1) persons are generally more sensitive to financial losses than to gains (especially when those gains are intangible savings).

2) when it comes to drugs, a decreased or absent co-pays every 30 or 90 days has little impact on the daily decision to take a pill

3) increases in cost dissuade patients that already want a service or medication; decreases target a different population of patients who are not engaged and are already paying nothing.

Implications for the population health management industry and the patient centered medical home: coaching patients to take their medications or to pursue needed testing may require significantly different approaches depending on out-of-pocket co-pay arrangement.   Patients are more likely to view cost sharing as a barrier, while those with little cost-sharing may benefit from additional incentives.

More On Why The Prognosis of Accountable Care Organizations (ACOs) Is Guarded and How Should Population Health Management Providers Position Themselves

For a long time, the more than 5000 regular visitors to the Disease Management Care Blog have been aware of the gap separating the promise and reality of Accountable Care Organizations (ACOs). That's why the DMCB salutes the editors of Health Affairs, who have decided it's time to extend the same courtesy to its readership with a well written article by Lawton Burns and Mark Pauly titled "Accountable Care Organizations May Have Difficulty Avoiding The Failures Of Integrated Delivery Networks Of The 1990s."

Remember the 1990's style integrated physician-hospital delivery systems? The DMCB sure does. Like the modern ACOs, these systems' business model were also based on care coordination, incentives alignment, risk bearing, salaried physicians and horizontal and vertical organization.

According to Drs. Burns and Pauly, they flamed out because they paid physicians too much for their practices, lacked adequate information technology, failed to achieve economies of scale, couldn't coordinate care and entered into "piecemeal" capitated contracts.  Last but not least, the typical 1990's style integrated system was never really "integrated" at all: it was made up of multiple provider entities that were simply bolted together.

ACO advocates argue it's going to be really different this time. Information technology is cheaper and more robust, new payment approaches (such as upside risk and bundled payments) are more user friendly, health care administrators are more adept at squeezing costs from the system and purchasers are demanding value over volume.  Toss in patient-centeredness, accountability, transparency, paying zero for physicians' practices and the momentum of federal payment reform, and it's easy to see why ACO-skeptics like the DMCB readers are being viewed as paper-medical record-loving party-pooping pinheads who pine for fee-for-service.

For the record, the DMCB categorically denies being a pinhead. But it and Drs. Burns and Pauly agree there are plenty of reasons to be skeptical.  Among the article's points that resonated with the DMCB are:

1) Most attempts at hospital-physician integration have not ended well, thanks to conflicting goals have not achieved quality, cost, cooperation or integration. Will economics and information technology finally trump culture?  We'll see.

2) Care coordination is no less difficult compared to the 1990s because it not only relies on timely information, but patient self management and nurse coordinators. The parallel flame-out of early versions of disease management also taught us that it is not a panacea for all patients with all chronic conditions being cared for by multiple providers in open networks. It works best when it is targeted at persons with a high burden of disease with readiness to change.

3) Medical homes take years to develop, thanks to years of transformative change management. Just because you're an ACO doesn't mean you're good at it and, what's more, you don't have years.

4) Clinically-based health information technology such as point-of-care decision support, electronic records and computerized physician entry have been inconsistently successful. And that's being generous.

But the authors don't stop there.  They describe four ACO "Achilles heels":

1) If PCPs are truly the linchpin to ACOs' success, it should also be pointed out that they are in short supply. It remains to be seen if they'll welcome a loss of professional autonomy or be willing to accept compensation that remains a fraction of their specialist colleagues;

2) Assuming large integrated systems comprised of a hundred or more physicians are truly able to achieve economies of scale, they won't spontaneously appear.  They take years to develop and mature.  See medical homes above.

3) Utilization of health care services outside an ACO's network not only outside their control but is very expensive, and

4) Maybe ACOs are a "disruptive technology" but the ultimate judge will be consumers.  They have yet to weigh in.

Implications for the population health management (PHM) service providers:

1. As ACOs struggle with their primary care providers and scramble for medical home and large health system-style care coordination services, "outsourced" nurse-based coaching will be very much in demand. But you already know this.

2. Given their national footprint, PHM providers may be in the best position to assist with those out of network or out of state ACO enrollees.  That's a new thought.

3. Keep a Plan B available just in case, and despite your help, ACOs collapse of their own weight.

The Dilemma of Medicare Coverage of "Reasonable and Necessary" Care and Why It's Important

If you get sick, health insurance should cover all the "stuff" necessary to make you better, right?

While that sounds good in principle, Uncle Sam has made it a lot more complicated than that.  As we continue to struggle with health reform, this New England Journal article on "Medicare's Enduring Struggle to Define Reasonable and Necessary Care" is very timely.

According to Drs. Neumann and Chambers, Medicare has always covered medical services that are "reasonable and necessary." As new approaches, drugs and medical technologies have been released, you'd think coverage would be based on an objective analysis of outcomes and cost effectiveness.

You'd be wrong.

Years of differing interpretations, patient advocacy, Congressional meddling, regulatory carve-outs and case law have generated a miasma of bureaucratic complexity that will guarantee the incomes of thousands of lawyers for years to come.

Not that CMS hasn't tried to be reasonable about "reasonable and necessary." According to the article, in 1989 CMS specifically proposed that the words "cost effective" could be used to assess new technology. That proved too controversial. It later tried "least costly alternative language" for coverage of durable medical equipment and Part B medications.  This too was dismantled by the courts when plaintiffs argued that the term "reasonable and necessary" could only be applied to medical services, not to the costs of those services.

How ironic. Even though CMS is making "value-based purchasing" judgements for hospital payments and costs can be factored in the coverage of preventive services, that still doesn't apply to new technologies and drugs.

The latest dysfunction is CMS' pretzel logic of "coverage with evidence  development" approach to medical devices, essentially agreeing to coverage that is conditional on CMS' evaluation of additional outcomes data.  Unfortunately, CMS' ability to collect and interpret these kinds of data in the current political environment remains an open question.

Outside of Medicare's cost travails, why is all of this important?

1) Medicare's price tag was $509 billion in 2010, taking 12% of the federal budget. While there are other drivers of cost, such as aging, coverage arrangements, income, pricing, administrative costs and defensive medicine, technology could account from 38% to more than 65% of the current growth (inflation) in spending.  Medicare's historic inability to control this does not bode well for future cost projections.

2) This is not a partisan issue and there are no partisan solutions.

3) Commercial insurers generally use Medicare's coverage criteria to define their own benefit structure.  Medicare's problems are everyone else's.

4) This is another reason why Medicare is banking on ACOs.  By delegating management and the associated risk of all these thorny coverage issues, they're hoping ACOs can do within three years what CMS couldn't do in three decades. We'll see.