My last blog described the terribly fragmented healthcare delivery system that nephrologists, and, more importantly, patients have to navigate just to get reasonable care. We all know that this system, particularly for the frail, elderly and chronically ill is terribly broken. Well over a year ago a new savior was introduced to the healthcare/health policy area—Accountable Care Organizations or ACOs.  This was touted as a new approach for financing care, but making providers accountable for holistic care of a population of patients, holding providers to specific quality targets, and rewarding excellence in quality, also resulted in financial savings. Most providers understood that to achieve higher quality and constrain costs, reorganization of the delivery paradigm would be necessary and collaboration would be the key to success.

Almost immediately hospitals jumped onto the ACO bandwagon—since in any redesign of a massive system like healthcare there would clearly be winners and losers—and hospitals saw the potential improvement in quality and focus on efficiency eroding their revenues and their influence.  They began buying physician practices as a way of mitigating this problem—physician employees would be loyal to the hospital, would accept lower salaries, and all would be well. Some specialties followed this path in lockstep-, more than 70% of cardiologists now work as salaried employees of health systems, primarily hospitals or other integrated care systems.

Nephrologists have always been independent thinkers and have largely resisted making such hasty decisions. While acknowledging that ACOs may provide an opportunity to improve quality and to permit excellent nephrologists to share in the financial savings, they are none too happy about getting in bed with hospitals. Of much more interest to nephrologists is how they might convince the healthcare community and CMS that an ACO structure with the nephrologist as the principal care providers makes the most sense for ESRD patients, and for the overall goals of improving outcomes and controlling costs.

ESRD patients are the prototype of the chronically ill—average age over 60, three to four co-morbid conditions, on eight to 10 different medicines, seeing one to four additional specialists, in the hospital 12 to18 days per year, and despite small numbers (<1% of all Medicare patients), consuming massive amounts of Medicare dollars (7-10%). Recently completed demonstration projects show that the renal community knows how to re-engineer care for this population, drive better care, and lower hospitalization rates and total costs. Delivering holistic care to these vulnerable patients can only be done with the leadership of nephrologists, and the time for this is now. While the preliminary regulations issued by CMS would make an ACO with ESRD patients as the designated members, with nephrologists as principal care providers not possible, the Center of Medicare and Medicaid Innovation (CMMI) is very interested in such an approach. As a renal community we need to fight to make sure that this is an option that is made available to our patients and to us as providers concerned about achieving the best possible outcomes for our patients.

As patient advocates we should be concerned that the complexity of care needed by ESRD patients will overwhelm a general ACO and our patients will either not benefit from the care coordination approach or will be excluded from joining. Neither of these would be acceptable options.  DaVita, Fresenius and the Renal Physicians Association are working hard together to educate CMMI on the value of an ACO focused on ESRD patients to the patients and the overall healthcare system. With continued persuasive dialogue we are hopeful that this view will prevail and that pilots of this approach will be permitted soon. For continued information on this topic and to further express your views please respond to this blog and check out the Accountable Kidney Care Collaborative website and its blog as well.

Senator John Kerry said it well: “Fixing our healthcare system as a whole is our primary challenge, and to make it happen you need to get engaged–to pound the pavement, get your hands dirty, endure real sacrifice, take on antiquated thinking and help lead the public debate.”

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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I have a close friend, Eliot who is a highly successful academic physician.  I have known him for nearly 35 years, and our lives have crossed in many interesting ways over the years.  He grew up in an affluent suburb in Boston, similar to where I grew up in Chicago, each of us part of large loving families including incredible younger brothers with whom we were very close.  He has done extensive work with NIH and industry funded research in his area of interest, similar to my work in kidney disease.  This story is not really about me or Eliot, but about Eliot’s brother, Steve.

Steve was four years younger than Eliot and as he grew and started high school it became clear that he had an incredible intellectual gift.  Many called him a genius, and he excelled not only in academics, but had a full and rewarding social life.  No one was surprised when he was accepted to Stanford for undergraduate work, and he settled into California smoothly.  He decided to become a doctor, like his older brother and was accepted to Stanford Medical School.  During his senior year at Stanford undergraduate, however, things started to change and by the middle of his freshman year in medical school he was diagnosed with schizophrenia.  He struggled valiantly to continue with many adjustments in medications but by sophomore year he had to drop out and shortly thereafter he was living in an  assisted living facility.  Two years later he had a complete medical evaluation because of severe fatigue and was found to have CKD- a kidney biopsy was consistent with amyloidosis.  Over the next three years he developed ESRD and started in-center hemodialysis.

By this time Steve was approaching 40 years old, and because of a family history of colon cancer his primary care doctor felt a screening colonoscopy should be performed.   The procedure was scheduled on a day between dialysis days, the colon was normal except for a few benign looking polyps which were biopsied, and there were no complications noted.  Steve returned for an uneventful  routine dialysis the following day, went home, and was found the next morning in a massive pool of blood.  He had bled to death from his rectum during the night.

Did Steve have an incompetent PCP or nephrologist?  A lousy dialysis facility?  Bad luck?  NO!  Steve was a tragic example of the highly fragmented care that is delivered to patients with kidney disease that leads to poor outcomes and limits the ability of patients to achieve their full quantity and quality of life despite having a devastating illness.  The fact that a care delivery system could fail so badly, even for highly educated patients, is unacceptable.  ESRD patients are among the most complex medically that have to navigate this system- 3-4 co-morbid conditions, 8-10 different medications, 3-7 physician providers, and on it goes.  Add to this the lack of an electronic health record, and the current disorganized care is understandable- the system is broken.

Of course the reimbursement system magnifies this compartmentalization of care.  Investing in proactive care, including critical care coordination, is under the purview of Medicare Part B, but is generally not reimbursed.  This is ironic since the result of such care coordination is a decrease in unnecessary hospitalizations, as overall quality is improved.  This results in  significant savings to Medicare Part A, more than enough savings to offset the costs of the care delivered.  This money is not made available to Part B, however, under the dominant fee for service system.   Over the past 15 years there has been a clear demonstration by a number of organizations that care coordination can significantly improve clinical outcomes for ESRD patients and constrain the costs of care.  In order to carry out these programs, however, such groups as Kaiser, DaVita and Fresenius have had to rely on contracting with commercial insurers (Medicare Advantage programs) or participating in CMS Demonstration projects.  There have been two such Demos in the past decade, both showing improved outcomes and constrained costs, but there is no plan from CMS to now extend such programs to the full
ESRD population.

The latest iteration of care coordination focusing on improving quality and controlling costs is ACOs (accountable care organizations).  A construct contained in the Affordable Care Act, the recently published preliminary rules unfortunately make ACOs focused on ESRD patients difficult if not impossible to carry out.  While the new Center for Medicare and Medicaid Innovation (CMMI) may be another vehicle for a new care coordination pilot in ESRD, the renal community needs to be vocal in asking:  Why another Demo?  Who will advocate for the ESRD patient in general ACOs?  Why is it so difficult to get the attention of policy makers for this vulnerable, costly population, particularly when a care delivery model that could have significant positive impact has already been proven to work?

It’s time for us to redouble our efforts to push decision makers to do what is right for our patients.

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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Recently CMS convened a series of technical expert panels (TEPs) that were charged with recommending new clinical performance measures (CPMs) that could be submitted to the National Quality Forum (NQF) for endorsement.  As a member of the fluid management TEP I was able to follow the process from start to finish, and we should all be concerned about the process and the way we need to drive better quality for our patients.

The purpose of a CPM is to change behavior on the part of a practitioner.  That is, the CPM is derived from rigorous evidence in the literature, and is then constructed to set a target for a particular outcome based on the evidence.  For example, if best evidence suggests that patients have better survival with Kt/V≥1.2, the CPM would be the fraction of patients achieving this goal, and targets would be set based on current performance and projections of what should be desirable and achievable.

When the four TEPs completed their work, however, it became clear that the lack of rigorous evidence in the literature severely limited what CPMs could be based on solid evidence.  Despite this fact, and the recommendations of a separate data TEP- a group that opined on the availability of the data needed to calculate performance on each CPM proposed- that there were significant gaps in this area, 44 measures were forwarded to NQF for consideration.  A mere handful were endorsed since NQF has an appropriately high bar that CPMs must meet, particularly regarding quality of the evidence base, before they will be endorsed.

Many of my colleagues who participated in the process expressed disappointment or even outrage that the work of experts could be rejected by NQF.  It was clear to me, however, that since CPMs are used by regulators and payers and others to judge the performance of providers it is essential that such measures truly are based on evidence, and unfortunately many of ours were not or the evidence was scant and weak.

Thus the conundrum- does the lack of evidence that meets CPM standards mean that we are now paralyzed in driving the quality agenda forward?  I think we need to step back and think more clearly about the difference between measuring quality for accountability purposes and driving quality improvement for patients.  This to me is best understood using the OJ Simpson analogy.  As many of you will recall this renowned football player was accused of brutally murdering his wife and her friend.  Mr. Simpson was acquitted in the criminal case but lost in a civil case brought by the victim’s family.  In the former, to be convicted in criminal court there needed to be proof beyond a reasonable doubt while in the latter a preponderance of the evidence was sufficient.

We need to ask ourselves, although CPMs need to meet the “proof beyond a reasonable doubt” standard, quality improvement initiatives do not, in my view.  The art of medicine mandates that clinicians make their best judgment, based on whatever evidence is available, and on the balance between risk and benefit, on what should be tried and what shouldn’t.  This approach should be applied not only to the care of individual patients, but to populations as well.  Each of us would be wise to review the 44 CPM recommendations that came out of the TEPs and consider how to apply them to our dialysis populations- they may not meet the proof beyond a reasonable doubt standard, but if implemented they will do more to help improve patient outcomes than will waiting for the next big randomized controlled trial.

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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