Dr. Deb has cued up the iPod playlist edition of Grand Rounds.  No DRM issues to be concerned with . . . put on your headphones and enjoy.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

The fact that a hospital has a Joint Commission survey due within the next year or so is not ordinarily newsworthy.  However, the Boston Globe spilled some ink today on the Massachusetts General Hospital's upcoming survey and the General's preparations -- including a mock survey, which is a standard preparation tool, particularly for facilities that have been working on improving their performance.  Last survey cycle, MGH was dinged for issues including recordkeeping and lax handwashing practices (look down a few grafs), and the mock survey was not quite perfect.  Then again, who's perfect?

The Globe's Jeffrey Krasner reported:

In a recent e-mail to staff, Dr. Peter Slavin, Mass. General's president, said the survey showed some areas still need improvement and must be addressed "immediately."

Slavin said the hospital has to make sure staff members better follow "universal protocols," or sets of instructions for individual procedures; ensure that patients have physicals 24 hours before surgery; improve the documentation of anesthesia and sedation procedures; and more closely monitor patients who are in pain.

The hospital has also begun an internal communications program, called Excellence Every Day.

The General seems to be emphasizing the continuous quality improvement approach to hospital operations, which is laudable.  It also brings to mind the focus of the Joint Commission's new rival, DNV.

The article continued:

It found that while there is perfect compliance with universal protocols in operating rooms, throughout the entire hospital the step was only followed 84 percent of the time . . . . In conducting a universal protocol, doctors and nurses review an upcoming procedure, make sure they have all the necessary supplies, and come to a "full stop," in which everyone stops what they're doing and makes eye contact before proceeding.

Survey or no, this is clearly an important effort, and one the General can devote resources to as it strives to maintain its level of clinical excellence.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

The latest comment period for imaging appropriateness measures is underway.  CMS announced last week that through The Lewin Group and its subcontractors, the National Imaging Associates, Inc., (NIA) and Dobson | DaVanzo & Associates, LLC, it is developing a preliminary set of outpatient imaging efficiency measures, and is seeking input through December 14, 2008 at the Imaging Measures website, which has a wealth of information on the measures (descriptions of the four measures are excerpted below) which, interestingly enough, are entirely different from the four measures featured at the same URL a year ago.  The measures may be used by CMS under MIPPA as part of the accreditation regime and are certainly preferable to the prior authorization regime currently in favor.

Here are the four measures:

MEASURE ONE: SPECT MPI AND Stress Echocardiography for Preoperative Evaluation for Low-Risk Non-Cardiac Surgery Risk Assessment

Setting: Outpatient
Numerator: Patients having a low-risk surgery (i.e., endoscopic procedure, superficial procedure, cataract surgery, breast biopsy) preceded, within 30 days, by a single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), Stress Echocardiography, or Stress magnetic resonance imaging (MRI) study
Denominator: Patients having a low-risk surgery (i.e., endoscopic procedure, superficial procedure, cataract surgery, breast biopsy)

A review of stress echocardiography appropriateness criteria for specific clinical scenarios was recently completed and published by The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE). Review of SPECT MPI appropriateness criteria for specific clinical scenarios was completed and published by ACCF and the American Society of Nuclear Cardiology (ASNC). The purpose of the published criteria is to "help guide a more efficient and equitable allocation of health care resources."

The proposed measure seeks to calculate relative use of stress echocardiography, stress MRI, and SPECT MPI prior to low-risk non-cardiac surgical procedures.

The appropriateness criteria provided specific guidance that use of stress echocardiography and SPECT MPI are not appropriate tests for preoperative evaluation of patients undergoing low risk non-cardiac surgical procedures. The appropriateness score assigned to the use of stress echocardiography and SPECT MPI for the indication is the lowest at one (1). Scores of 1-3 are defined as inappropriate (the test is generally not indicated).

The criteria define low risk surgery as cardiac death or MI in less than 1 percent of performed procedures — endoscopic procedures, superficial procedures, cataract surgery, and breast surgery (biopsy).

MEASURE TWO: Use of Stress Echocardiography or SPECT MPI Post-Revascularization Coronary Artery Bypass Graft

Setting: Outpatient
Numerator: Patients who have had a stress echocardiography or SPECT MPI study in the five-year period following a coronary artery bypass graft (CABG) procedure.
Denominator: Patients who have had a CABG procedure.
Exclusions: All tests performed in the first six months post-CABG; any patient with clinical risk predictors for silent ischemia or accelerated coronary artery disease (CAD) (e.g., diabetes); and any patient who undergoes a catheterization, percutaneous coronary intervention (PCI), or CABG procedure in the six months following the post-revascularization Stress Echocardiography or SPECT MPI.

A review of stress echocardiography appropriateness criteria for specific clinical scenarios was recently completed and published by The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE). Review of SPECT MPI appropriateness criteria for specific clinical scenarios was completed and published by ACCF and the American Society of Nuclear Cardiology (ASNC). The purpose of the published criteria is to "help guide a more efficient and equitable allocation of health care resources."

The proposed measure seeks to estimate relative use of stress echocardiography and SPECT MPI in asymptomatic patients less than five years after a CABG procedure.

The appropriateness criteria provided specific guidance that use of stress echocardiography is not appropriate for risk assessment within five years for asymptomatic patients. The appropriateness score assigned to the use of stress echocardiography for the indication is two (2). Scores of 1-3 are defined as inappropriate (the test is generally not indicated). Use of SPECT MPI for the indication was scored at six (6). Scores of 4 -6 are defined as uncertain.

MEASURE THREE: Use of Computed Tomography in Emergency Department for Headache

Setting: Emergency Department (ED)
Numerator: ED visits with a presenting complaint of headache with a coincident brain CT study
Denominator: ED visits with a presenting complaint of headache
Exclusions: Patients who are hospitalized (admitted), patients who are transferred to another acute care hospital, patients with a lumbar puncture, diagnosis codes indicative of dizziness, paresthesia, lack of coordination, subarachnoid hemorrhage, or thunderclap.

Clinical guidelines and literature indicate that there is a general consensus that neuroimaging is rarely productive for [headache] patients with normal physical and neurological exams and medical histories. Unnecessary CT is costly financially, in false positive interpretation, and in excess radiation. This measure seeks to identify inappropriate practice patterns.

MEASURE FOUR: Simultaneous Use of Brain Computed Tomography and Sinus Computed Tomography

Setting: Outpatient
Numerator: Patients with a presenting complaint of headache who have a brain computed tomography (CT) and sinus CT study performed simultaneously (i.e., on the same date at the same facility)
Denominator: Patients with a presenting complaint of headache who have a brain CT study
Exclusions: Patients with trauma diagnoses, tumor, or orbital cellulitis

Clinical guidelines and literature indicate that there is a general consensus that neuroimaging is rarely productive for patients with normal physical and neurological exams and medical histories. Even when neuroimaging is required, there are no indications for simultaneous Brain CT and Sinus CT. Moreover, unnecessary CT imaging is costly financially, risks false positive interpretation, and exposes patients to excess radiation.

(Emphasis supplied.)

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

The post-election edition of Health Wonk Review is up at Colorado Health Insurance Insider.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

. . . wherein Dr. Rob offers some llama-inflected job advice for an anonymous correspondent (rhymes with "no llama").

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Yesterday I had the opportunity to chat with several members of the executive leadership team from DNV Healthcare, the "new kid on the block" for hospital accreditation.  DNV was recently granted deeming authority by CMS -- the first time the federales have taken such a step since recognizing the Joint Commission about 40 years ago.  (The AOA has deeming authority for osteopathic hospitals.)  I spoke with Darrel Scott, Senior Vice President, Patrick Horine, Executive Vice President - Accreditation, and Becky Wise, Chief Operating Officer, and learned more about DNV, ISO 9001, and the National Integrated Accreditation for Healthcare Organizations (NIAHO) standards. 

DNV developed its NIAHO standards for hospital accreditation, building upon both the Medicare COPs and on ISO 9001, a quality management standard that the DNV judged would enable hospitals to most effectively address -- and avoid -- issues such as never events.  ISO 9001 is specifically designed to address service organizations (rather than, e.g., manufacturing), and is proven as a basis for quality improvement.

In essence, NIAHO requires hospitals to implement ISO 9001 as a means to achieving compliance with the COPs.  ISO 9001 is a vehicle to implement and maintain a quality management system which ensures compliance with COPs across all hospital processes.  DNV views a "process" as being a holistic whole, cutting across traditional silos of hospital departments (such as nursing, pharmacy, IT, housekeeping, etc.) -- so a process is "acute hospital inpatient care," not "radiology turnaround time."  A hospital would likely have no more than a dozen "processes" by this definition.

NIAHO standards speak to the COPs more directly. DNV is differentiating itself from the Joint Commission by observing that, for example, the JC requires that in order to meet the no-wrong-site-surgery element of the COPs, hospital employees and medical staff follow a prescribed process.  Failure to adhere to the process means a ding on a survey.  By contrast, the ISO 9001 approach requires that there be some reliable process in place to assure that no wrong-site surgeries take place, but does not prescribe the particular mechanism.  In shorthand, ISO 9001 is the "what," not the "how."  That can be a good thing or a bad thing.  DNV is clearly pitching this as a good thing: giving hospitals much greater flexibility than the Joint Commission approach.  The challenge for hospitals and their advisors is to ensure that there be either sufficient local innovation and development -- or cross-pollination, or communication with other organizations -- of best practices, to ensure optimum patient care in the absence of specific patient safety goals or other standards. 

ISO 9001 compliance will not require hiring of new staff; entities that are currently JC-accredited are "about 70% of the way there."  Annual visits (vs. every-three-year JC surveys) will promote more of a continuous quality improvement mindset.  In addition to the survey visits, each department in a hospital needs to be audited by another department on an annual basis.  A positive side effect of the interdepartmental audits is expected to be an overall improvement in communication across silos, leading to a reduction in errors in handoffs and otherwise.

After accrediting a couple dozen U.S. hospitals during its "out-of-town tryouts," DNV says that it is ready to ramp up and begin surveying hospitals nationwide, having engaged and trained a cadre of surveyors as employees and contractors -- nearly 100 to date.   These surveyors are cross-trained both as ISO 9001 lead auditors and as generalist, clinical or life safety code surveyors.  (DNV affiliates have conducted ISO certifications of over 1,200 health care facilities worldwide.)

One potential bump in the road is state hospital licensure regulations.  In the HealthBlawger's unscientific survey of two states, hospital licensure regs require a licensure survey by state surveyors unless the hospital is Joint Commission-accredited (Joint Commission is named in the regs).  At least one of these states has expressed a reluctance to make the change to more generic language that would recognize the CMS-approved DNV accreditation in lieu of a licensure survey.  DNV's view is that these issues will not prove to be long-lived, and that state hospital associations are likely to carry the water on this one at the behest of their membership.

DNV stresses that ISO 9001 compliance is not required day one in order to obtain DNV accreditation.  There is a two-year ramp-up period to allow for hospitals to learn the ropes and come into compliance. 

One of the positive aspects of the new system highlighted by DNV is that there is no "tipping point" -- no threshold number of negative findings that will edge a hospital out of compliance.  Instead, any nonconformities will require corrective action plans.  If the nonconformities are "Category 1" (i.e., more severe), the corrective action must be taken within 60 days, or the hospital moves into "jeopardy" -- and risks losing accreditation.  This aspect, among others, has impressed DNV executive leadership with the value of open dialogue between hospital and survey team, made more likely given the less likely event of an operations-stopping notice of deficiencies.

DNV offers "sustainability" -- DNV standards change only if COPs or ISO 9001 standards change.  This may be attractive to some hospitals, which have balked at some Joint Commission requirements/revisions in recent years.  (The MS 1.20 - Medical Staff By-Laws saga comes to mind as one example.)

Check out the DNV website for FAQs, articles, and info on full-day workshops coming up over the next month or so.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

. . . for a presidential-history-filled edition of Grand Rounds.  Read, learn and enjoy.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Massachusetts identity theft regs take effect January 1, 2009.  Any business that does no more than keep a copy of a personal check from a client or customer on file is subject to these new rules, which require implementation of a security program covering any "personal information" maintained in a business' files.  "Personal information" means any non-public linking of a person's name and Social Security Number, driver's license number, or financial account number (debit, credit or bank account number).  The enabling statue does not apply to state government agencies, but Gov. Patrick brought them into the big tent by executive order.

Internal and external security audits and employee training will be required.  

For those lucky enough (!) to be subject to HIPAA already, these requirements will not be that difficult to accommodate, as the new rules cover familiar territory.  However, HIPAA pre-emption analyses and compliance programs will need to be reviewed, to be sure that Massachusetts health care providers, payors and clearinghouses maintain full compliance with both federal and state rules in this area.

Both healthcare and non-healthcare-sector businesses may have to consider doing a further pre-emption analysis, looking at the recently-delayed FTC Red Flag rule.  

If HIPAA regulation and compliance efforts are an indicator, one of the thornier issues to deal with in coming into compliance with these rules will be establishing parameters for remote access of personal information.  Also, as under HIPAA, it will be interesting to see whether private enforcement efforts will be permitted under the new law. 

TOH: Colin Coleman, John Koenig.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Massachusetts identity theft regs take effect January 1, 2009. Any business that does no more than keep a copy of a personal check from a client or customer on file is subject to these new rules, which require implementation of... David Harlow

The 2009 Medicare Physician Fee Schedule regulation was released in final form yesterday (on display), and will be published in the Federal Register on November 19.  It is chock full of payment and policy changes, detailed in three CMS fact sheets: (1) payment policies and rates; (2) MIPPA-related changes; and (3) e-prescribing incentives and PQRI updates.

A few highlights:

• MIPPA's 1.1 % MPFS rate increase in lieu of the previously-scheduled SGR pay cut
• Deferral of the proposed incentive payment and shared savings (gainsharing) Stark exception, together with a call for further comment
• Revision of the anti-markup rule
• Roll-out of IDTF standards and enrollment requirements to all physician-based and non-physician-practitioner-(NPP)-based IDTF-like services (with accommodation made for mobile IDTFs that operate "under arrangements" with hospitals)
  
• Imaging accreditation and appropriateness criteria under MIPPA (follow link to earlier HealthBlawg post on the subject)
  
• E-prescribing incentives -- available under MIPPA -- phases down from a bonus in the first five years for early adopters (2% in year 1, less as time goes by) to a penalty thereafter (ramps up over time to a 2% penalty) to drag the last holdouts, kicking and screaming, into the system
• 52 more PQRI measures -- 153 and counting -- for the CMS pay-for-reporting system, with a bump up in to potential bonus from 1.5% to 2% (also thanks to MIPPA)

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Updated 11/3/08

Don Berwick, CEO of the Institute for Healthcare Improvement, spoke with HealthBlawg last week, as IHI comes close to wrapping up its 5 Million Lives Campaign.

The audio file of my interview with Don Berwick (about 20 minutes long) is available for download/podcast. A full transcript is at the end of this post (and in the linked transcript.

IHI sponsors an impressive array of collaborative health care improvement programs, offering programmatic support and creating a network of like-minded institutions and leaders who provide feedback to each other on improvements to their local systems.  The 5 Million Lives Campaign is the latest in a long line of successful campaigns.

I asked Berwick about the plethora of health care indicators used in P4P and pay-for-reporting plans, and he suggested that the 1,000 measures in use today could be whittled down to far fewer, that the "cacophony" could be eliminated, with better results for patients.  The 5 Million Lives Campaign, for example, is built on twelve "planks," ranging from reduction in infections and med errors to board engagement -- the latter, a critical measure not often cited in connection with patient care process and outcome measurement.  He also noted that NQF will be making an announcement in the near future identifying six key predictive measures.

IHI uses these indicators to "pull" health care providers into improved quality, according to Berwick; payors use them to "push" providers along.

Berwick estimates that 30% of costs in the U.S. health care system are "pure waste" -- excess administrative costs and medical expenses, where variation is based on habit, not evidence.  The current economic climate brings greater urgency to the need to bring these costs under control.  

While cautioning that information technology "isn't magic," Berwick emphasized that he has been calling for widespread implementation of EHRs for 30 years, so long as the EHR roll-out doesn't simply transfer paper processes to the computer but, rather, serves as an opportunity to redesign patient care and administrative processes.

Another opportunity for improvement lies in improving coordination of care across traditional boundaries -- e.g., primary care to acute care to chronic care.  Berwick used the "M" word to describe the mechanism most likely to help in this arena: managed care: "not the evil managed care, not the mutant managed care, but the good managed care," that could really help patients, e.g., through a chronic illness.

In discussing future policy directions post-election, Berwick stressed that the U.S.needs to join the rest of the industrialized world and recognize health care as a right.  It seems clear that if that were to happen, many other changes in the health care system would need to be made as well -- finance, delivery system, health care provider training and supply -- all topics worth further examination another day.   

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Interview of Donald Berwick, CEO of the Institute for Healthcare Improvement
October 28, 2008

David Harlow:  This is David Harlow of HealthBlawg, and I have with me today Don Berwick, CEO of the Institute for Healthcare Improvement.  Good morning, Dr. Berwick.

Don Berwick:  Good morning.

David Harlow:  Thank you for joining us today.  I wonder, for starters -- though I’m sure many folks are familiar with your organization -- if you could give us a snapshot description of what your organization does and its mission.

Don Berwick:  Sure.  The Institute for Healthcare Improvement, IHI, is a non-profit organization started in 1991 by a group of colleagues around the United States.  Our mission is to help accelerate the improvement of healthcare system all over the world.  We have projects mostly in the US and Canada but also in Europe, the Pacific and South Africa now and several developing countries.  So our basic work is research and development first.  We try to identify or create prototypes that really perform current designs in healthcare for better safety and effectiveness and patient-centeredness and lower cost.  We then try to test those prototypes with colleague organizations around the country or around the world, hospitals or clinics or practices that are willing to try new designs and see if they work and debug them.  And then we have lots of activities to spread the innovations we can find that are helpful.  We do this through large meetings.  We have our big national conference coming up in December which will have about 6,000 people there and 15,000 on satellite.  We have a website.  It’s open to everyone, ihi.org.  And in the past four years, we sponsored major national campaigns, the 100,000 Lives Campaign and the 5 Million Lives Campaign, which are intended to get literally thousands of hospitals to adopt a focused set of changes that make patients safer and reduce unnecessary harm and mortality.

David Harlow:  Yes.  And I understand that through the 5 Million Lives Campaign that something on the order of 80% of US hospital beds are now in institutions that have signed on, if you will, to this campaign.

Don Berwick:  And the response has been amazing.  We proposed twelve changes in care processeses and governance in hospitals to make patients safer.  And I think the last number was 4,030 hospitals have signed up in the United States alone, and there’s spinoff campaigns being run by colleagues and friends in eight or nine other countries.  So the response has been pretty dramatic.  I’m sure but not all of the places are actually seriously changing process but many of them are, and we have been seeing phenomenal results in some.

David Harlow:  Well government payors, CMS, and private payors as well have been tracking particular care processes or care outcomes – I’d actually been interested to hear your perspective on that -- and have been using as the basis for pay-for-performance programs.  Now my understanding is that the programs that you’re describing are not necessarily tied to any payors but rather to care improvement in a more general sense.  Is that a fair statement?

Don Berwick:  Yeah.  IHI is one player in the changing landscape in healthcare that has both elements of push and elements of pull.  The pull is what IHI deals with; we’re working with hospitals and clinics and clinicians and leaders all over the world and appealing, I think, to their intentions to do well.  They want to be proud of their work and they’re interested in how to make changes and they’re being helped by transparency by turning the lights on and much better able to measure patients’ injuries or mortality or patient satisfaction for example to where we’ve ever been before.  So there’s a side here that reflects ambition, aspirations, kind of a spirit in the work force.  And I think that’s what IHI basically works with…but it’s no surprise.  There’s push also from the society at large, the payors like the government payors and private payors, the public at large represented through consumer groups, Consumers’ Union, AARP and so on, and the employers who are paying the bills upstream for their employees.  Those outsiders to healthcare want healthcare to be quite accountable.  And once it becomes evident that certain kinds of complications or extra cost or overuse or risks are reducible or in some cases can be eliminated, there’s no surprise that the environment, the payor community, the patients have wondered or are really asking and I guess, in some cases demanding that the changes be made.  There’s push and pull.

David Harlow:  I understand that yesterday IHI ran a national learning network event and I imagine a number of ideas along these lines were showcased.  I wonder if you could speak to a couple of them and maybe observations on where some of the successes are and what you see as some current trends.

Don Berwick:  Sure.  The National Network Day which was yesterday is one of the big national events we’ve been running in the campaign period of now four years of campaigning.  I should say first that the campaign that IHI is supported by philanthropy so that, for example the Blue Cross Blue Shield Association and Blue Cross Blue Shield plans around the United States have donated considerable amounts to IHI and to local entities that help spread changes.  Cardinal Health has helped.  Other foundations have helped.  So everything in the campaign is free.  There’s no cost to hospitals that want to get access to it.  So the campaign team has been funding different vehicles to give access to anyone that wants information on how to make changes and especially reports from places that have done so.

So yesterday was a day of sharing in which after some introductory remarks by among others, Richard Umbdenstock, the president of the American Hospital Association.  We ran, all day long, virtual workshops on the phone and internet and web in which hospitals can report in on things they are proud of doing or lessons they’ve been learning.  We had hospitals that have gone a year or two or in one case four years without a single ventilator pneumonia.  We have the central line bundle which causes reduction of bacteremia in patients with central lines -- they don’t get septic -- which we developed a number of years ago.  It has been expanded in the keystone project in Michigan.  And they did a workshop on prevention of bacteremia.  We have hospitals that are just making tremendous gains even in some cases hospitals that have reduced mortality rates measurably, dramatically in some cases.  So they’re sharing how they did it and then curious teams and hospital leaders who wanted to understand how others have done it can get that information.  We have about 200 mentor hospitals in the campaign.  These are the hospitals that we track major results reduction or pressure sores or improvement of heart attack care or reduction of infection and they sort of donate their knowledge back into the pool of knowledge.  And they also were available on this National Network Day.

We had through the day, I’m told, over 2,400 phone lines were open at one point or another to get these information.  At the peak we had something like 460 or 470 phone lines open with ten or twenty people at each phone line.  That’s thousands of people getting information from each other.

David Harlow:  That’s terrific.  And it’s very encouraging just to see the level of engagement in this sort of activity.  You mentioned earlier twelve changes in care processes that were to be undertaken and I’m wondering how you would compare these processes or how these processes are selected because I’m comparing that to the many -- in some cases, dozens and dozens of processes or indicators that are collected and reported on to various payors including government payors.  I guess the question is as hospitals are involved in dealing of a number of different payors and required to report on many different indicators, has your work shown that there is a small pool of  indicators that would really work as proxies for all these others in terms of institutional level of quality of care.

Don Berwick:  Well, David, first you’re absolutely right about the cacophony of indicators and measures.  Hospitals today have, I think, quite literally over 1,000 variables they have to report on somewhere about their own performance.  It really makes them crazy and it doesn’t allow for the kind of focus that we really need nationally.  And we don’t yet have a national agenda of prioritized improvements, what are the most important ones to make.  I think soon some will emerge with the National Quality Forum which is this public-private partnership group that’s going to articulate some goals.

In fact there is a press conference November 17th by NQF that’s going to lay out six goals for American care which I’m pretty excited about.  But the IHI’s campaign planks, we call them, the twelve planks, were picked because we had great evidence from the scientific literature, our own prior work, or the work of others, that these changes could be made by hospitals that they would result in reductions in harm and in some cases mortality and were not expensive to do.  So they’re a selected group.  They do overlap quite consciously with a lot of the indicators you’re referring to.  We have a matrix -- you can see it on our website -- that shows how if you’re on board the twelve campaign planks at the moment you’re really hitting a lot of other requirements from the Joint Commission and CMS and payors and so on.  So there’s some crosswalk.  There are also logical ones.  There are ones where everyone knows we can really make progress. A number of them bear on infection:  like reduction of surgical site infections, reduction of central line infections, reduction of ventilator pneumonias, reduction of methicillin-resistant staph infections.  There’s one on pressure sores, an avoidable complication that we know can be reduced dramatically within hospitals.  We’re focused on cardiac care, which is an enormous area for hospital work: both acute heart attack care, making that very reliable, and the same for congestive heart failure which is the most common reason for admission in Medicare.

There are are a number focused on drug errors, medication reconciliation when patients move from one place to another that’s one.  And another is a specific focus on high-alert medication -- that’s insulin, sedatives, narcotics, and anticoagulants -- which explain over half the serious injuries that patients get from medication errors in hospitals.

The twelfth plank is unusual and that’s not about a condition, it’s about governance.  We call it Boards on Board and that reflects the need, really the imperative, that hospital governance and executive leaders take, in this case, patient safety firmly under their stewardship.  This improvement in safety that we can achieve is not achieved without leadership from the boardroom and the executive suite.  So plank twelve, Boards on Board, it coaches hospital boards on how to take cognizance and really be helpful to the improvement of patient safety.  It’s kind of a rational set.  It doesn’t do everything.  There are other areas that we will be getting into.  In fact IHI, after this December meeting, December National Forum, we’re going to be articulating a set of entirely expanded set of goals and aims that are even more related to what’s happening in the environment right now.

David Harlow:  Great!  Are those would tie in with some of the other standards or goals that are being articulated by NQF and others?

Don Berwick:  Yeah.  We’re going to try to make sense of the cacophony so it won’t be just repeating a bunch of, a long, long list of standards but trying to come up with this real serious leverage.  And by the way, incorporating cost reduction -- because among the improvements you can achieve with really conscientious process management is reduce cost while helping increase the experience, improve the experience of patients and the staff so you’re going to see a number of initiatives on our part that are strongly focus on wise reduction and cost because we badly need those as well.

In the end, that’s where we’re headed for our hospitals -- because this campaign is focus on hospitals right now -- hospitals that function at a completely new level of reliability and patient-centeredness and lower cost.  And that’s what we’re going to try to accumulate and plan for over the coming months.

David Harlow:  Do you have a view on expanding some of this work to non-hospital settings as much of healthcare is moving -- ?

Don Berwick:  Oh yes for sure.  IHI has perhaps, well now close to half our work in the non-hospital settings.  Next March, just as we have our National Forum in the December, we have, I think, our tenth annual meeting called On Improving Office Practices and that focuses on ambulatory care, care across the continuum.  We currently have a grant from the Commonwealth Fund to work at the level of states on reduction of unnecessary hospitalization through improvement of care for chronic illness across the continuum.  We have a wonderful project with the Indian Health Service now which is focused on chronic disease care in the Indian Health Service which is almost completely an outpatient issue, not an inpatient issue.  We also have a major research and demonstration project now underway called the Triple Aim project which deals with population-based care, dealing even beyond care into issues of prevention of illness and the total per capita cost of healthcare in a population.  As of now, we have over forty organizations, most in the US but not all, working on innovations and new designs to improve care at the population level.  So we’re doing a lot more than just hospital care, but a lot of hazards lie in hospitals and so we’re going to keep the spotlight there as well.

David Harlow:  Yes.  You’ve mentioned cost control and cost management.  Do you see a focus on that increasing in the minds of hospital administrators given the current economic crunch or is this a long-standing issue that’s just being worked on now?

Don Berwick:  Access cost has been a problem in the US healthcare for three decades at least so it’s a chronic problem of high severity.  We’re at a great disadvantage economically as a country because of what we pour in to healthcare -- close to 17% of the GDP.  And since IHI is a global organization we work with and see systems in Europe and elsewhere that function at half our cost per capita and get results every bit as good as ours and, if you read the Commonwealth Fund’s research, in most cases a lot better.

We’re at the bottom of some lists that you’d expect that we’d be on top of given our expenditures so it’s chronic.  I think the latest financial crisis only adds fuel to that fire and I think converts a chronic crisis into something pretty close to an economic emergency.  And I’m sure hospitals are making major adjustments now as all organizations have to in our country and worldwide.

From IHI’s point of view, this is about waste.  It’s not about cutting back on things people need.  It has to do with getting very smart about what it is that we do that doesn’t help anybody and getting that out of the system.  My own estimate through the years has been that at least 30% of American healthcare costs are in that pot.  They don’t help anyone.  They’re just pure waste.  They’re administrative cost and excess care that can’t help, unscientific care, variation based on habit, not fact.  And conscientious professional leadership, conscientious organizational stewardship, and good public policy ought to be able to identify that overuse, that waste, and remove it from the system thus saving a lot of money without harming a single patient and advancing the health of communities.

David Harlow:  Do you see some of the new information technology tools as being particularly useful or more helpful in trying to move organizations into an evidence-based medicine mind set?  You and others have been talking for years about certain lean management principles, but as you’ve said there’s still a tremendous amount of excess cost in the system.  Do you see an opportunity with expansion of information technology in this area?

Don Berwick:  Yeah.  I’m of two minds on information technology and on the one hand, it’s kind of falling off a log to say we need it.  I mean, for Pete’s sake, we’re still not even in 20th century, let alone 21st century information technology in most of healthcare and it’s time to go there.  Our care would be more reliable.  The flow would be smoother.  Patients would be remembered.  Chronic disease care would be integrated.  Finance could be better managed if we have better information.  And so we definitely need to modernize healthcare information technologies and the underlying infrastructures and rule base for that.  There’s no question that would be helpful.  It’s time to have an electronic medical record and I was part of the Institute of Medicine committee thirty years ago that said that.

On the other hand, I don’t think we should expect information technology to be magic.  It isn’t magic.  In fact, the big mistake would be that we could introduce information technology and not change processes and then we’d just be automating the current inefficiencies and defects and it would be easy to that.  We have to do two things which are modernize information and change care and the combination would be extraordinarily powerful.  Is it necessary to modernize information in order to change care?  I don’t know.  At some level, no.  I think it’s possible for a local unit or clinic or hospital to do quite a bit with whatever information they happen to have, but it certainly would be helpful that we can get synergy between information management and improvement.

In some organizations we’re seeing that.  There are recent breakthrough, for example Kaiser Permanente which has invested literally billions of dollars on modernizing its information platform but they are also beginning to harvest from that important new forms of redesign, such as making home the hub for care.  That’s one of their slogans and it really is real.  And they’re going to exploit opportunities for better care with better information and I think could give us a good head ups on what’s possible.  They are not alone and so we need to be tracking these very progressive redesign projects.

David Harlow:  Sounds great.  So in sort of wrapping up, I’m wondering if there’s any other areas or any other advice that you might offer to healthcare organizations as we face both the economic crisis and a new administration in Washington, and also what you might have to say to a new administration in Washington, areas of emphasis that you would like to see from a federal policy perspective.

Don Berwick:  Well, let me start with policy and then I’ll talk about organizations.  At the  policy level, in our country, the most important leadership we need governmentally to me is back in the domain of ethics and human rights.  I mean, healthcare is in almost every other country in the world -- and certainly in every other developed country -- clearly a human right.  And they don’t negotiate on that point.  They then figure out how to make it so and struggle through the difficulties of doing that.  We haven’t done that in this country and I’m looking for congressional, presidential leadership that finally crosses that bridge and says it’s just not right to be a wealthy, first world country, and have anyone be denied healthcare that they need.  A big important form of that and also related to policy is to close the gap between rich and poor and black and white in our country.  The worst [sic] predictor of your health status today in America is the color of your skin and we need to end that as a fact.  It has to be changed, and so I think that is also a matter of public commitment and federal policy and governmental leadership.

At the more technical level, we need government leadership to modernize information technology, that’s clear.  We also need to reconfigure the role of government, especially as payor, to help us integrate care across boundaries.  We’re very fragmented in the way we pay for care even from the federal government level and we need better chronic disease care, especially, in this country.  And that’s going to involve new forms of integrated payment that return us to if I dare say the best kind of managed care not the evil managed care, not the mutant managed care, but the good managed care, that really means I’m helped in my journey through my chronic illness.  I think we need to focus on wise cost reduction and we need federal policy that supports that.  And we need to research on that so we understand what costs can be reduced without harming people.  We need much more voice for patients.  CMS and others have been very good in helping patients speak up through proper data and surveys and reporting requirements.  And I think we need even more of that.

On the organizational side, I would guess the two most important lessons I’ve been learning are first, it does take leadership.  Until executives, heads of boards, the lay executives, clinical executives, nursing leaders, physician leaders, own improvement of care as their job, it’s very hard for the workforce to get organized to make care better and we really need executives alert and at the helm to make care better.  It’s got to become part of the job, and every way we can do that will help.  The other good side of that lesson is, I think, executives who do that are going to find a workforce -- doctors, nurses, pharmacists, receptionists, therapists, and middle managers -- they’re going to find a work force ready to really help.  I mean IHI’s 5 Million Lives Campaign is uncovering this enormous amount of goodwill on the workforce to make care better.  It’s there.  And executives and boards that realize it and go for it are going to find it available and I think that’s a piece of good news that I want them to hear.

David Harlow:  That is a piece of good news.  And I thank you for joining us today.  I’ve been speaking with Don Berwick.  This is David Harlow on HealthBlawg.  And Dr. Berwick, thank you again for joining us.  I appreciate it and enjoyed our time speaking together.

Don Berwick:  Thank you, David.  It’s been my pleasure.

Don Berwick, CEO of the Institute for Healthcare Improvement, spoke with HealthBlawg last week, as IHI comes close to wrapping up its 5 Million Lives Campaign.The audio file of my interview with Don Berwick (about 20 minutes long) is available... David Harlow

The 2009 Medicare Physician Fee Schedule regulation was released in final form yesterday (on display), and will be published in the Federal Register on November 19. It is chock full of payment and policy changes, detailed in three CMS fact... David Harlow

All Hallow's Eve (celebrated around these parts tomorrow night) incorporates traditions tied to the earlier Celtic holiday of Samhain, which marks the beginning of winter -- as the great (swing) state (or should I say Commonwealth) of Pennsylvania knows only too well. 

As we enter the last lap of the interminable presidential campaign of 2008, with one eye on our 401(k)s and HSAs, keep these Samhain traditions in mind:  This is a time of renewal, lighting new fires, divination, and the day to go down to a "boundary stream," take three stones from the water with your eyes closed, put them under your pillow, "ask for a dream that will give you guidance or a solution to a problem, and the stones will bring it for you."  If you don't have a boundary stream handy, print out three copies of this post.  The wisdom of the crowds (or at least of the ragtag band of bloggers whose health wonkery is reviewed here today) may offer you that sort of guidance, though I'm fairly confident that it will not put you to sleep.

Why we do the things we do

No divination required here: for most rational economic actors, the why has a lot to do with the wherewithal.  Folks want to keep the home fires burning -- and that takes some cold hard cash.  

Also, as a species, we seem to be fascinated by shiny objects.  Take these two factors together, add a dose of separation of roles of health care consumer and health care payor, and the table is set for overconsumption of new (and often unproven) health care services (some of which involve office-based shiny objects), to the financial benefit of the provider. 

For a good treatment of the recently issued report from the Center for Studying Health System Change (with support from RWJF) titled “High and Rising Health Care Costs: Demystifying Health Care Spending,” see Maggie Mahar's discussion of the many observations synthesized by Paul Ginsburg at Health Beat.  The gestalt here is not new, but clearly identifying and quantifying the ways in which our dysfunctional health care system promotes the utilization of new therapies should prove instructive for the new health care policy cadres about to descent on the Potomac (now there's a boundary stream for you).  Maggie quotes Don Berwick, who has written about our oversupply of health care resources -- warms the cockles of my former-CON-regulator heart -- in her discussion.  (By the way, for all you Don Berwick fans out there: I will be posting my recent interview with him in a day or so, so be sure to check back.)

Daniel Goldberg, writing at the superbly-designed Medical Humanities Blog picks up on this thread and highlights the applicability of the McKeown thesis (hey, you all know what that is, right?) to this discussion.  In brief, McKeown's thesis is that medicine isn't necessarily all it's cracked up to be -- 17th-to 20th-century improvements in population health measures likely had more to do with social and economic changes (e.g., improvements in the standard of living) than with public health and medicine (e.g., drugs and shiny objects). 

At Colorado Health Insurance Insider, Louise Norris focuses on this report, too, and takes issue with Maggie's statement that the federales should be doing a better job of negotiating proces, given their market power, noting that in at least some cases they have done so.  

The almighty dollar

David Hamilton, blogging at BNET's Health Care Industry, tells us that trouble with Mammon drives for-profit HMOs to drive up Medicare Advantage premiums.  (Hey, they're for-profit companies.)  This is related to the brouhaha over brokers' fees on Medicare Advantage policy sales -- see the WSJ Health Blog for more on that story (including a link to a hortatory letter from Pete Stark to CMS).

David Williams reminds us that it takes two to tango -- pharma companies can't pay outlandish "consulting" fees to physicians unless physicians take them -- and his Health Business Blog tells us of GlaxoSmithKline's new policy limiting such payments and requiring public disclosure of payments.

Ontario's provincial government just inked a deal with the physicians' union cutting physician pay.  The union may be splintering (some members smell a sellout).  Shades of Sustainable Growth Rate rules and overrides.  A tip of the hat to Sam Solomon at Canadian Medicine.

These three posts raise (yet again . . . ) the question of whether health care delivery and financing systems need serious reform in order to unskew the incentives and ensure that expenses are held in check.

There's no place like home

A medical home, that is.  The question of the moment is whether the medical home is the flavor of the month or something more.  Much has been written in recent weeks about the implementation of the medical home model by Geisinger.  (The HealthBlawger thinks the medical home is something of a new spin on the good old PCP or family doctor back home in Kansas.)  I wrote about Geisinger's success with the medical home model and observed that what they've got that others ain't got is (not courage, but) PCPs.  Can't have a medical home without PCPs. 

Joanne Kenen, of New Health Dialogue, interviewed Geisinger CEO Glenn Steele, who presents the medical home initiative as one of a series of experiments.  John Iglehart, writing at Health Affairs, calls for further development of the medical home model in response to the WHO's call for increased efforts in the primary care arena worldwide.  

We'll always have "Decision '08"

Come next Wednesday, there will be no more comparisons of presidential candidates' health care reform plans.  Really.  But no worries, don't hyperventilate -- we'll wean you off slowly, starting with the Brain Blogger's two health care and politics wrapups: one each for the Red and the Blue.

For last licks on the McCain health care reform plan, we turn first to Jason Shafrin, the Healthcare Economist, who takes a look at how much that McCain policy would actually cost a person after the tax credit.  Anthony Wright joins the fun at Health Access, picking up on the McCain camp's October surprise.  And finally, Bob Laszewski, at Healthcare Policy and Marketplace Review, laments that -- win or lose -- McCain's proposed replacement of employer-based health care insurance with a personal responsibility model is likely on the outs.

Is it the Economy, Stupid?

The fires in the engines of our economy seem to be taking an early break for Samhain, and a number of bloggers have been wrestling with the implications.  At Health Care Renewal, Roy Poses castigates Ascension Health for its cut and run maneuver in Detroit, closing an inner city hospital while building a new suburban facility.  Adam Fein looks at some historical data at Drug Channels and posits that the economy's nosedive will not bring on a reduction in drugstore sales.

Brian Klepper spoke at the recent Health 2.0 conference in San Francisco about Health 2.0 amid the economic downturn, and posted a version of those remarks at The Health Care Blog.  Given the belt-tightening, Brian sees Health 2.0 tools as a welcome means to help squeeze the waste out of the system.  (The HealthBlawger didn't make it out there, but did attend the Health 2.0 Northeast get-together earlier this month.) 

At Workers' Comp Insider, you may follow Jon Coppelman through the looking-glass as he reviews the implications of the financial crisis for workers' comp.

Annie, blogging at Home of the Brave, wonders why nurses and nursing aren't a bigger part of the discussion on health care reform, given their work in the front lines.

And finally, InsureBlog's Hank Stern has a "duh" moment followed by an "aha" moment (it must be that Samhain-season sense of renewal . . . ) when reading that targeted social services for a homeless population can reduce emergency department and other hospital utilization for "frequent fliers" by nearly two thirds. 

Evidence-based medicine: An analogy too far?

Jaan Sidorov, at Disease Management Care Blog really let Billy Beane, John Kerry and Newt Gingrich's baseball analogies (in a NY Times op-ed piece on evidence-based medicine) get under his skin.  "Health care is different" he says, and of course it is.  (I can only take a few minutes of baseball announcer balderdash on hyper-obscure and often meaningless statistics, but Lord knows I can drone on about health care ad infinitum.) 

Clearly, though, Jaan would not throw out the evidence-based baby with the baseball bathwater.  There are metrics that are useful (and probably a dozen times as many that are not particularly useful) in health care.  The challenge is in discerning the wheat from the chaff. 

I understand, by the way, that NQF has been culling through its vast repository of measures in order to identify the really predictive ones.  Stay tuned for an announcement on that front within a few weeks. 

Well, if you had been paying attention to the emanations from your three river stones, you would have realized that this brings you to the end of the final pre-election edition of Health Wonk Review. 

See you on the other side.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

All Hallow's Eve (celebrated around these parts tomorrow night) incorporates traditions tied to the earlier Celtic holiday of Samhain, which marks the beginning of winter -- as the great (swing) state (or should I say Commonwealth) of Pennsylvania knows only... David Harlow

I spoke last month with Radiology Today on the question of HIPAA compliance, in light of increased, or at least more public, enforcement.  HIPAA security compliance audits are underway, and providers need to be aware of what to expect.  The best defense is still a good offense, which in this case means conducting an audit and beefing up policies and procedures, as necessary.  For further information, see an earlier HealthBlawg post. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

The organization formerly known as JCAHO finally has a little competition, after a 30-year-plus lock on the deeming business.  While the Joint Commission has changed with the times (looking more at process, not just at outcomes), its hospital survey process -- which is recognized by CMS so that passing a JC survey means that a hospital is "deemed" to be in compliance with Medicare Conditions of Participation (aka Medicare certified) and can forego a government survey -- has been the only game in town.  (Only about 5% of hospitals ever face a "validation" survey with government surveyors.)  The JC accreditation system has come under criticism on a number of fronts (I'm just framing the criticisms, not endorsing them):

• Surveys only take place every three years, resulting in a rush to come into compliance before survey time, with less attention paid to standards in the years in between

• Even surprise visits come with advance notice

• Survey reports are not made public

• Sentinel event reporting is recommended, rather than required

• JC surveys are paid for directly by the surveyed hospitals

• JC sells consulting services to hospitals to help them prepare for surveys

A while back, CMS formally opened up the deeming process, so that the Joint Commission (and the American Osteopathic Association, the other deeming authority out there) had to reapply, and the application process was open to others as well.  The new kid on the block is the US health care division of a Norwegian company, DNV -- Det Norske Veritas Healthcare, Inc.  The CMS approval of the DNV accreditation program was issued September 26 and published on September 29.  It's good for four years.

A couple dozen US hospitals hold dual certification (JC and DNV), and it will be very interesting to see how many hospitals move to DNV accreditation in the future.  Some of the advantages touted by DNV:

• Annual surveys, promoting continuous quality improvement

• Surveyors cross-trained as ISO 9001 lead auditors, promoting a more collaborative relationship with hospital staff (see ISO website and an interesting "plain English" take on ISO 9001.) 

Per DNV's press release,

NIAHO [i.e., DNV's National Integrated Accreditation for Healthcare Organizations] encourages innovation within individual hospitals while helping them take advantage of system-wide best practices. It is the first hospital accreditation program in the United States that integrates the internationally recognized ISO 9001 Quality Management System with the Medicare Conditions of Participation, making it the first and only hospital accreditation program that requires continual quality improvement. 

A few other observations: Other coverage notes that a shift to DNV from JC will require a comprehensive revierw of policies and procedures and contracts that may incorporate references to JC or its standards. One early adopter quoted in the DNV press release noted that the shift of emphasis in the accreditation process eased her institution's transition to an EHR system.  In order to be certified under ISO 9001, not only surveyors need to be ISO certified -- hospital staff need to be certified as well. 

Bottom line, it seems like this may be a disruptive innovation that could help hospitals in the long run -- particularly those that have been itching to opt out of the JC monopoly for years -- but may have some not-insignificant transition costs.  In addition, the greater transparency sought by some critics of the JC monopoly is not guaranteed simply by opening up the process to another player.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Last week saw the most recent Health 2.0 conference in San Francisco. While I did not make it out to the left coast for the event, I got a tiny taste in advance, at the second Health 2.0 Northeast confab... David Harlow

Last week saw the most recent Health 2.0 conference in San Francisco.  While I did not make it out to the left coast for the event, I got a tiny taste in advance, at the second Health 2.0 Northeast confab earlier this month in Cambridge (our fair city), MA.  (Like John Grohol of e-patients.net, I enjoyed networking before the formal program.) 

I was struck by a number of differences in tone and content from the last Health 2.0 Northeast event.  For starters, many of the companies featured in the presentations and panel discussion are not what I would call Health 2.0 companies.  Second, moderator Wade Roush (of Xconomy) asked each panelist to explain their business model (!) -- the ever-elusive monetizaton of Health 2.0, and a concern that is more front-and-center these days. 

Patients Like Me and Wego Health seem to qualify as Health 2.0 companies, creating a forum for user-generated content, and harnessing the wisdom, or at least the experience, of the crowds.  American Well (a site that connects beneficiaries of participating health plans with on-call docs via the web or even telephone), Tangerine Wellness (weight loss programs for employee groups), Silverlink (reminder phone calls), and the Endovascular Forum (an on-line forum for physicians who perform endoscopic procedures) really don't seem to fit the bill.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

A year or so ago, Ascension Health wanted nothing to do with Caritas Christi. The national Catholic health care system considered buying the Boston-based Catholic health system after it put itself on the block, but backed away given the toxic... David Harlow