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10 posts from February 2010

February 28, 2010

Diagnostic Radiology Controls: David Harlow Interviews MITA Executive Director Dave Fischer

MITA Executive Director Dave Fischer spoke with HealthBlawg last week about industry efforts to control radiation dose in diagnostic radiology modalities such as CT. 

A congressional hearing on radiation dose control took place the day after we spoke, and the FDA will be holding a hearing on diagnostic radiology issues in late March.  Earlier last week, timed in part perhaps because of the upcomng congressional committee hearing, MITA kicked off the dose check initiative, a tool for manufacturers and providers to use in better regulating diagnostic imaging radiation dose, which Dave Fischer describes in our interview.  He also referred to the CMS demonstration project on appropriateness of imaging services now underway, authorized by MIPPA.  

It now seems surprising that there has been no demand by clinicians, technologists, medical physicists, regulators, accreditation entities, consumer groups or others for this sort of rudimentary standard-setting and introduction of failsafe mechanisms to avoid dangerous levels of medical radiation, and a more rigorous approach to a cost-benefit analysis for CT scan ordering (though the CMS demo is perhaps a good first step).  However, media reports about unreasonably high radiation doses in the CT setting at Cedars-Sinai and elsewhere around the country have galvanized our attention so that we have focused on this issue. 

Here's hoping that in the future, areas of concern may be identified empirically and safeguards put in place before patients are harmed. 

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

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog
Interview of Dave Fischer, Executive Director of MITA
(Medical Imaging and Radiation Therapy Manufacturers Alliance)

February 25, 2010

David Harlow:  This is David Harlow at HealthBlawg, and I have with me today Dave Fischer who is the Executive Director of the Medical Imaging and Radiation Therapy Manufacturers Alliance, or MITA.  It’s an organization that represents most of the manufacturers of equipment in this area and works to establish some common principles and protocols for this industry.  Dave, I appreciate you taking the time to speak with HealthBlawg.

Dave Fischer:  Of course.

David Harlow:  Dave, I am interested - as we all are - in exploring questions about patient safety in dealing with imaging technologies, particularly in light of the news about CT scanner dose issues, initially at Cedars-Sinai last fall and then, as came out, elsewhere in the country.  And now we’re looking at an information gathering process and probably a regulation development process with FDA as a result of the public hearing that’s being held next month.  And I’m interested in hearing from you about where you see the industry right now, how you see the industry as a whole responding to this issue and how you see the interplay between the equipment-related issues and the professional practice related issues whether it’s physician issues or technologist issues.

Dave Fischer:  Sure, I think might be instructive to start with describing just for a minute  the distinct difference between imaging manufacturers and imaging technologies and radiation therapy technologies.  The diagnostic technologies, for example CT, on the ionizing radiation side of the equation are specifically designed for detecting abnormalities in a patient.  And over the course of nearly a decade MITA and its member companies have been working to reduce dose for the use of those technologies.  And the thing I think whether it’s through new innovative technologies or new practices, new information provided to operators, we’ve been working diligently to reduce dose and to provide the same quality of image for the patients and their providers.  On the radiation therapy side of the equation, actually the intent of the therapy is to use radiation to kill cancer cells.  And so the focus there is to focus the radiation to a specific spot without damaging surrounding tissues.  And so when folks talk about or people talk about dose reduction, they are generally talking about the diagnostic side of the equation.  Now, with regard how we have been responding to radiation dose issues and you’ve mentioned a number of things that have been in the press recently, like I said a moment ago, on the diagnostic imaging side our companies have spent years developing technologies to reduce the amount of radiation that a quality scan requires as well as providing operators with additional information about the amount of radiation a particular scan will utilize to make that image.  And many of these features are designed specifically to reduce radiation and to make the operator aware of the amount of radiation so that changes can be made prior to the scan to reduce the amount of radiation a patient will actually receive.  Now, how do manufacturers interact or what’s the partnership between all of the different folks who work on this?  Now, I think like I just mentioned, it clearly is a partnership.  The equipment that we manufacture is a tool that physicians, medical physicists, technologists all use to screen patients or treat patients or determine if they have disease.  And in all of these cases, we have to work in partnership with all of these providers to ensure the safe and effective use of our equipment.

David Harlow:  Now, one of the issues raised in anticipation of the FDA hearings is a question about establishing radiation dose reference levels, which relates to one of the things you were just saying.  And I’m wondering what you see as the way forward for incorporating this information and failsafe controls into the everyday workflow of the professionals using this requirement.

Dave Fischer:  I’m glad you asked about that.  One of the things that we’ve announced this week with regard to reducing radiation dose and making operators more aware of dose is the CT manufacturers have all agreed to three things.  One, to what we call a dose check or the MITA dose check initiative.  Those items are first, a dose alert - already the equipment provides the operator with a dose level for a particular scan.  However, we believe it’s important to put that level into context, and so we’re creating a tool that will allow providers or hospital imaging centers to enter in reference levels just as you mentioned just a moment ago to provide the operator with a data point to help them understand where the dose in the scan they are about to do - the dose level for that scan ranks in the overall distribution of dose for that particular type of scan.  And so it’s like a yellow light.  It’s an alert to allow that make sure the operators know this is above our reference level, we need to have a very good reason for that.  Second thing, --

David Harlow:  So if I can interrupt you just to make sure we understand that.  What you’re saying is that you’re going to create the technology to establish a set of guardrails if you will and each institution would calibrate those guardrails.

Dave Fischer:  I think it is a decent analogy.  I mean, we’re creating the tool to inform the operator but it will require the imaging facility or the hospital to provide the data, the information, the value that would cause that pop up screen to come up.  In addition, I’ve mentioned the yellow light, we’ve also created a red light, which is a dose warning if a particular scan has the potential to be dangerous to a patient.  A perfect example of this is a scan that has enough radiation to cause deterministic effects, like hair loss or burns.  Now, there is almost no reason why a CT machine would ever cause that unless it had been set inappropriately.  And so we want to make sure that if that is set that way that we have a red light that pops up - a warning - to the operator to let them know there is something wrong here that you need to check out.  The last thing, and this is something I think that will fit very nicely into the President’s recent proposal for a national dose registry.  We believe that this dose information needs to be recorded in a standard manner.  It currently is recorded in the DICOM system, which is the language of interchange, the exchange language that allows imaging products to all communicate with each other.  But recording this dose image in a standard manner will also facilitate the use of a national dose registry as well as facilitate the analysis of dose to make sure to better understand how it use, how it changes, how it varies.

David Harlow:  And what do you see as the likely timeline for implementation of this system?  You say that CT manufacturers have agreed to move forward with this; will this involves significant retrofitting of existing systems?

Dave Fischer:  CT manufacturers will begin to apply this technology to their new releases beginning this year.

David Harlow:  So new releases meaning software upgrades to machines that are –

Dave Fischer:  That are being sold, correct.  And then additionally we will also begin pushing out this technology to the installed base as well.

David Harlow:  You mentioned earlier the notion that doses on average per study have been reduced overtime.  And my question there is - another analogy if you will, the introduction of the catalytic converter reduced automobile emissions tremendously but then again the volume of vehicle miles has increased tremendously since that time.  So what are we looking at in terms of controls on the uses of the technology, the numbers of scans per thousand population, is that on your radar screen as well?

Dave Fischer:  Absolutely. One of the things that we’re strong supporters of is something called appropriateness criteria, there was actually legislative language with that theme that was included in a physician payment update bill about a year and a half ago.  What the appropriateness criteria means is we want to make sure that the patients gets the right scan at the right time.  What that means is we want to incorporate into the physicians’ thinking that CT or other diagnostic imaging is appropriate for certain conditions in certain periods and it should be used in those times in those periods.  We do not support the idea of the principle of maximizing CT scans or any diagnostic tool. We believe we should be using the right scan at the right time.

David Harlow:  And so are you working through that initiative with clinical groups, professional organizations to develop the evidence based guidelines that may affect utilization?

Dave Fischer:  Manufacturers can’t practice medicine and so we really have to leave it to the professionals in that area.  But I can tell you that the Center for Medicare and Medicaid Services is beginning to implement the demonstration program that was included in the MIPPA bill.

David Harlow:  Do you participate with the professional associations, societies in terms of education programs in order to get the word out about issues like this?

Dave Fischer:  Oh, absolutely.  Another example is the Image Gently Campaign, which is run by the American College of Radiology.  We’re a participant in the Image Gently Campaign which is specifically designed to reduce radiation in pediatric medicine so that is one example of our efforts to work closely with the radiologists, the physicians, medical physicists in that effort.  We will be cosponsoring both a CT dose summit and a radiation therapy dose summit in the coming month.  We believe very strongly in the partnership that I mentioned earlier between all the providers and the manufacturers.

David Harlow:  Is it too early to see a result from that partnership, from those educational efforts?  I ask because in recent weeks there has been news about evidence based medicine studies that show relative benefits of different approaches to managing care – I’m thinking specifically of stents versus medications in the cardiac arena - and despite the evidence, clinical practice does not seem to be shifting.

Dave Fischer:  There is a larger issue within our healthcare system about variations in care across the country.  What we feel like as manufacturers what we feel we can do is do our best to make sure we’re educating our customers as well as the national societies and also in our local level to try to make sure they understand our views on the applicable reasons for these tests.

David Harlow:  What else can you tell us about communications with either the FDA or with other regulators at the federal and state level, or professional associations at the federal and state level, dialog around this issue and where you see this going in the context of the upcoming of public hearing at the end of March?

Dave Fischer:  Last fall, MITA convened a stakeholders meeting with radiologists, physicists, technologists as well as the FDA, to discuss the issues of radiation dose and we have been working since then on this topic with them and communicating with them.  Those meetings were the beginning of our own efforts to create the MITA dose check initiative.  And we welcomed the FDA’s announcement a couple of weeks ago.  Much of what they have proposed are things that we agree with and we intend to work closely with the FDA and participate fully in the FDA’s process moving forward.

David Harlow:  One of the other points that you’ve endorsed is the expansion of mandatory accreditation for advanced imaging facilities and my sense is that many if not most payers already require some sort of accreditation in order to bring facilities into their networks.  Do you see an additional significant opportunity for further accreditation?

Dave Fischer:  I believe the accreditation program that was included in the MIPPA bill that that I mentioned earlier is for the non-hospital setting.  We support examination of whether or not that policy needs to be expanded to include hospitals.  Generally speaking, I think there is a lot of value to accreditation in the sense that it ensures that an imaging facility is up to speed on all of the different techniques, that their machines work appropriately.  And I think its also important to remember this is a new program that has just gotten of the ground.  And so I believe there is a lot of room for moving providers into that category.

David Harlow:  Another issue raised in these endorsements is the notion of some standards for personnel involved in the imaging exams and radiation therapy treatments.  And I’m wondering whether you see our 50-state system as an impediment to achieving this sort of standardization?

Dave Fischer:  Our organization hasn’t taken a position on whether or not the minimum standards that we support should be a national-based system or a state-based system.  I think the key is that we establish the standards for training and education for the personnel performing medical imaging exams in the radiation therapy arena, I’m sorry in the radiation arena.

David Harlow:  We spoke a little bit about a national dosage registry and I’m wondering whether there is any comparable registry in place today where the infrastructure could be built on that is in current use among the professionals who’d be called upon to using this registry?

Dave Fischer:  I do not know the answer to that question.

David Harlow:  Is that something that you have been involved in looking at talking about what the infrastructure would be for that registry?

Dave Fischer:  The challenge with a registry system like this is that we have, as everyone knows, a fragmented healthcare system, that is the nature of our system.  And as we add health information technology we gain additional ability to gather this information and to understand it.  While it’s true that the imaging sector is fairly advanced in regard to exchanging information - like I mentioned the DICOM standard earlier - and in recording dose information, having that information at a single hospital doesn’t provide you the same robust information that it would if it’s captured by a city or a state or a hospital system or a national version of that.  And so what I think is critical first about our dose check initiative is (1) standardizing the recording of that information so it’s more easily accessible and then (2) just the ongoing development and advancement of health information technology which will facilitate the sharing of that information over time.

David Harlow:  So you’re saying that just as an example, the DICOM standard could be used in order to support a registry that would be interoperable or could receive information and share information with existing provider systems in place?

Dave Fischer:  Absolutely, it’s already functioning, it includes radiation dose information and in fact the FDA mentions the DICOM standard in their white paper. 

David Harlow:  What would you expect that future to bring this says public hearing is called for the end of next month, what do you as happening over the next 6 to 18 months as a result of that hearing?

Dave Fischer:  I expect we’re going to see additional efforts.  I could speak from my own organization’s perspective.  I mentioned today our dose check initiative for CT: we’re already exploring ways to expand that effort to include radiation therapy, nuclear medicine as well as x-ray.  So we believe that including additional information for the providers and the operators of this equipment is essential to reducing medical errors and we will continue that effort.  I expect that FDA will continue to examine this.  I do not know whether or not they will issue regulations or how will impact the clearance process.  But we intend to work with FDA closely to ensure that the newest innovations are able to get to market and to make sure that medical radiation is reduced and medical errors as well.

David Harlow:  Well, thank you very much.  I’ve been speaking with Dave Fischer, Executive Director of the Medical Imaging and Radiation Therapy Manufacturers Alliance.  Thanks again, Dave.

Dave Fischer:  Thank you.

February 26, 2010

MPFS in Crisis: Holding of Claims for Services Paid Under the 2010 Medicare Physician Fee Schedule

Days of Future Passed (or: deja vu all over again). 

Late Friday, after business hours, CMS pushed the following announcement via its physician information listserv:

The Centers for Medicare & Medicaid Services (CMS) is working with Congress, health care providers, and the beneficiary community to avoid disruption in the delivery of health care services and payment of claims for physicians, non-physician practitioners, and other providers of services paid under the Medicare physician fee schedule. As you are aware, the Department of Defense Appropriations Act of 2010 provided a zero percent (0%) update to the 2010 MPFS effective for dates of service January 1, 2010, through February 28, 2010. 

We believe Congress is working to avoid the negative update that will take effect March 1.  Consequently, CMS has instructed its contractors to hold claims containing services paid under the MPFS for the first 10 business days of March. The holding of MPFS claims will only affect claims with dates of service March 1, 2010, and forward.  This hold should have a minimum impact on provider cash flow because, under current law, clean electronic claims are not paid any sooner than 14 calendar days (29 for paper claims) after the date of receipt.  Be on the alert for more information about the 2010 Medicare Physician Fee Schedule Update.

It's exhausting already, but CMS published a rule requiring a 21.5% 2010 MPFS cut and Congress dutifully rolled back the damage -- but only for two months.  The cut is effective March 1, which is why CMS had to step in as outlined above, basically giving Congress a week to do something.

Why such a high cut?  As I've written earlier:

That's because Congress has overridden every other cut mandated by the law since 2002, yet has not taken the time to rethink it -- even though it called for a review in 2005's DRA, and MedPAC obliged in 2007.  To cut to the chase, MedPAC recommended that Congress either (a) come up with another cockamamie formula or (b) repeal the SGR and develop incentives for providers to provide higher quality care at lower cost.  Yes, they've done a fine job so far . . . .

CMS has had to take the last-minute administrative approach in the past, to give Congress time to offer another band-aid, or temporary fix.  Here's hoping that some comprehensive fix can be worked through per MedPAC's 2007 recommendations. 

Update 3/3/10:  The latest band-aid: a one-month extension of the delay of the cuts with no comprehensive approach to the SGR formula-driven MPFS cuts.  This issue gets bigger by the minute, but Congress is loathe to wrap it into the larger health reform debate, because doing so would kick the health reform package over the magic $1 trillion mark.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Social Media for Lawyers presentation at Law Practice Management program, Western New England College

I will be presenting a talk today at the Business of Lawyering program at Western New England College's Law and Business Center for Advancing Entrepreneurship.  For those who are interested, here are my slides.  I would be interested in your feedback.

Update 3/12/10: I gave the same presentation yesterday at the plenary session on social media at the Massachusetts Bar Associaton Annual Conference.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 25, 2010

White House Health Care Summit: Watch it Live

Watch the White House Health Care Summit here (live beginning at 10:00 am EST today, or later), and check out the President's health reform proposal, too.  (Video is archived on this site as well.)

Update 3/2/10:

Obama Letter to Congressional Leaders After Health Care Summit

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 22, 2010

HIPAA enforcement: Business Associate Agreement rulemaking needed first - time to plan ahead

After learning of comments on HIPAA enforcement made by a member of the HHS OCR legal staff at an ABA meeting on health care issues, I contacted him directly.  Adam Greene confirmed that HITECH Act changes to HIPAA rules regarding business associate agreements will be implemented through standard notice and comment rulemaking, noting that this has been OCR's public take on the issue.  Thus, a notice of proposed rulemaking will be published "shortly," followed by promulgation of a final rule after a comment period.  Even thought the statute calls for the BAA provisions to be effective this month, they clearly will not be.  The breach notification and penalty provisions are already the subject of an interim final rule, so they are in effect. 

As I wrote several months ago,

"business associates" under HIPAA are now required to implement policies and procedures to maintain privacy and security of PHI, parallel to those that have been required of "covered entities" under HIPAA since the beginning. All business associate agreements and notice of privacy practices (NPPs) will have to be updated to account for the new requirements before February. Health care providers that wish to distinguish themselves should consider revising their NPPs to highlight the ease with which they will make copies of records available to patients. This is a bone of contention for many patients, and ensuring that patients' rights to their records are easily exercised could be a way to build goodwill among patients and potential patients.

Thanks to Bob Coffield for pointing to the post on the ABA meeting and raising the question.

I urge all covered entitites and business associates to take heed of these new requirements and begin planning now for implementation of the soon-to-be-released regulations.  Don't sit back and end up being made an example of by OCR (e.g., with a million-dollar fine) or by a state attorney general.  Contact the HealthBlawger now.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 14, 2010

Massachusetts Health Reform: Is Back-to-the-Future Rate Regulation the Way to Lead the Nation Right Now?

The Massachusetts health reform law, Part II - enacted in 2008 - laid the groundwork for cost control and quality improvement, as a follow-on to the initial legislation's emphasis on achieving near-universal coverage.  The legislation authorized several studies -- including a report published a few months back on global payment strategies -- and set the stage for hearings on health care cost containment to be held before the state Division of Health Care Finance and Policy (DHCFP), which are scheduled to begin March 16, 2010.

Update 2/18/10: Paul Levy posted a series of questions DHCFP would like hospitals to answer at the hearings at Running a Hospital. 

In anticipation of these hearings, and as required by the law, the Attorney General's office released a report on health care cost trends and cost drivers on January 29.  While the names of providers and payors are not included in this report, it provides a fascinating level of detail regarding what we already knew, or at least suspected: some providers are paid as much as twice as much as others for the same services, with no correlation to improved quality or outcomes.  The AG's summary conclusions in full:

[O]ur preliminary review has revealed serious system-wide failings in the commercial health care marketplace which, if unaddressed, imperil access to affordable, quality health care. In brief, our investigation has shown:

A. Prices paid by health insurance companies to hospitals and physician groups vary significantly within the same geographic area and amongst providers offering similar levels of service.

B. Price variations are not correlated to (1) quality of care, (2) the sickness or complexity of the population being served, (3) the extent to which a provider is responsible for caring for a large portion of patients on Medicare or Medicaid, or (4) whether a provider is an academic teaching or research facility. Moreover, (5) price variations are not adequately explained by differences in hospital costs of delivering similar services at similar facilities.

C. Price variations are correlated to market leverage as measured by the relative market position of the hospital or provider group compared with other hospitals or provider groups within a geographic region or within a group of academic medical centers.

D. Variation in total medical expenses on a per member per month basis is not correlated to the methodology used to pay for health care, with total medical expenses sometimes higher for globally paid providers than for providers paid on a fee-for-service basis.

E. Price increases, not increases in utilization, caused most of the increases in health care costs during the past few years in Massachusetts.

F. The commercial health care marketplace has been distorted by contracting practices that reinforce and perpetuate disparities in pricing.

This report is well worth reading, and it is well-illustrated with clear charts.  While the detail is welcome, many have criticized the AG's office for leaving out identifying information, and for coming to the party a year after the Boston Globe reported on some of the same issues.

At the end of last week, DHCFP released a series of three reports on health care cost trends as well.  The DHCFP reports are summarized here; they really serve to describe the baseline facts on the ground and explore trends form 2006 through 2008.  Here's the summary of key findings:

    * The Commonwealth's health care system is a key employer and driver of economic growth for the region. However, personal health spending per capita is higher in Massachusetts relative to the nation and continues to rise.

    * Some characteristics of the Massachusetts health care marketplace that may be contributing to the high levels of cost growth, include:
          o High concentration of physicians (especially specialists);
          o Greater availability and use of academic medical centers for both inpatient and outpatient hospital based-services, and use of outpatient hospital-based facilities for some services that could be provided in less costly settings;
          o Richer health insurance benefits compared to the nation; and
          o Use of payment methods that are not designed to incentivize efficiency and coordination of medical care.

    * Most of a health insurance premium goes toward spending on health care services as opposed to administrative and other non-medical services. On average, in Massachusetts more than 88% of premiums are spent on health care expenses (compared to less than 84% nationally).

    * Average monthly health insurance premiums increased 12% from 2006 to 2008.  If employers and individuals had purchased comparable benefits each year, the growth in premiums would have been larger.

    * Premium trends, benefit levels, and trends in health care spending vary across different-sized employer groups.  Small group premiums were higher and grew faster on average than mid-size and large group premiums, when adjusted for differences in benefits, demographics and location.   

    * Health care spending in the Commonwealth increased 7.5% per year from 2006 through 2008, a growth rate that is higher than the nation.  The increased spending can be attributed to several factors:

          o Price was an important factor contributing to rising health care spending across all service types.
          o One area of particular concern (and opportunity) is the variation in prices, which was typically greater for facility charges than professional charges.
          o In addition to price increases, care is being provided in more expensive settings over time—more inpatient care is being provided in academic medical centers and there is a decline in the provision of care at stand-alone outpatient facilities.   Much of the growth in outpatient hospital care occurred at academic medical centers located in the metro Boston area.

Again: no surprise here -- Massachusetts health care costs are higher than national averages, and are growing at an unsustainable rate.

The challenge before Massachusetts policymakers is clear:  They need to put together these puzzle pieces of data, learn from the past, model potential solutions, and plan for the future.  Even the national mainstream media acknowledges that, in the face of health reform meltdown, doing nothing is not an option.  (Where were they six months ago?)

In the midst of this challenge, Governor Deval Patrick seems to be distracted by health reform's implications for his political future.  Instead of waiting for a reasoned outcome of the deliberative process set in motion two years ago (well, as reasoned as possible, given the heavy-duty political and economic interests at stake here), he has leapt into the fray with what looks like an ill-conceived bit of political grandstanding: a bill that would give the state insurance commissioner the authority to cap health care price increases.  The Boston Globe reports:
Rates hospitals and other health providers charge insurers would be “presumptively disapproved as excessive’’ if they increased faster than the level of medical inflation, and they could be rejected after a public hearing.

Similarly, for health insurance plans sold to employers with 50 or fewer workers, premium increases that exceed one and a half times the level of medical inflation would be considered excessive and could be turned down.

The legislation would also impose a two-year moratorium on lawmakers’ mandating any new health benefits that must be covered by insurance plans, a practice that employers have said drives up their health insurance premiums. Small businesses have been hit with double-digit rate increases in recent years.
This proposal brings us back to the future here in Massachusetts:  Twenty years ago, Patrick's presumptive GOP challenger in the fall, Charlie Baker (who, thanks to some of his views being out of step with GOP orthodoxy, will likely draw many of the significant number of independent voters in Massachusetts, as well as some Democrats), was largely responsible for the dismantling of the Massachusetts health care rate setting system during his tenure in budget and health policy roles in the Weld administration.  (In fact, some of us who have been around long enough still refer to DHCFP as "the agency formerly known as Rate Setting.")  (As a second aside: For those of you tuning in from afar, Baker's most recent position was CEO of Harvard Pilgrim Health Care, one of the three dominant payors in the Commonwealth.)   Is Patrick trying to stake out a position in opposition to Baker's legacy?  What constituency is going to buy into this vision of the future?  Other local observers have also questioned the wisdom of this approach, including fellow health policy bloggers Evan Falchuck and Paul Levy.  (Taking a cue from Paul's musings on blogger disclosure in connection with this issue, I'll just say that as a life-long registered Democrat, I have voted for a Republican maybe just once.) 

Deregulation was successful twenty years ago because we were collectively convinced that payors could do a better job of holding providers' feet to the fire.  We later framed this in terms of holding providers accountable, and have employed a variety of tools over time to try and make this private-sector arrangement work: capitation, discounted fee-for-service payments, quality incentives, global payments, etc., etc.  Patrick's proposal is one version of the general acknowledgment that the market approach has essentially failed. 

Instead of going back to the future, Governor Patrick ought to let the health reform process play out.  The legislature should hold the Governor's bill pending the DHCFP hearings and the subsequent deliberations that will -- we hope -- yield a more data-driven and sustainable approach to the problem of health care costs and quality. 

And who knows?  The national debate may continue to be informed by what comes out of Massachusetts.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 09, 2010

David Harlow continues the value-based design conversation with Wayne Burton, MD and Cyndy Nayer of the Center for Health Value Innovation

Today we bring you Part II of my conversation with Wayne Burton and Cyndy Nayer of the Center for Health Innovation, where we get into some specific examples of successful programs.  The Center represents over 40 million lives, and brings together employers and providers to focus on a limited number of levers targeted at health and wellness - rather than health care.  The ROI of wellness efforts in the workplace is pegged at nearly 300% in a recent Health Affairs article by Karen Baicker et al. and accompanying Health Affairs blog post by Jaan Sidorov - one of my fellow "Health Wonks."  Clearly this is an area that demands our attention. 

The audio file of Part II of my interview with Wayne Burton and Cyndy Nayer (about 20 minutes long) is available for download/podcast.  A full transcript of Part II is at the end of this post (and in the linked Wayne Burton and Cyndy Naylor interview transcript Part II).

Part I of the interview was posted yesterday.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog

Interview of Wayne Burton, MD, Member, Board of Strategic Advisors, Center for Health Value Innovation and Cyndy Nayer, Co-Founder and President, Center for Health Value Innovation

Part II of II
February 5, 2010

David Harlow:  So, in addition to reaching employees and family members, of course, these employers are businesses, and even these state entities have an eye on the bottom line these days,  and the question is, where is the return on investment?  What you folks are describing is essentially a significant additional layer of administrative effort and clinical effort and the question must come up: what is the return on all of this investment?  Have you quantified that for any of your members?  Have members quantified that?  What’s the ballpark?  What are we talking about?  

Wayne Burton:  Well, that’s an excellent question and in fact I believe it’s this month’s Health Affairs that has a paper on return on investment, a review article on wellness programs that shows the return on investment, and there are many, many demonstrations of that.  So the return is financial in terms of lower healthcare cost trends, but as important, and perhaps more importantly, are what’s termed the indirect cost for employers - that means fewer missed sick days, fewer disability days and increased on the job productivity.  

Cyndy Nayer:  We’ve seen and documented in our book quite a different range of dividends as we call them.  It goes from places like one company that linked both the use of the provider network that was practicing to evidence based guidelines with a copay reduction to the employees and covered lives, and they’ve documented $16 million worth of savings over five years.  We have another company who documented a flat medical trend so it was 4.9% medical trend year over year for five years straight, when other were paying anywhere from 9 to 13 and above percent increases year over year.  We have seen folks who’ve quantified cost avoidance, lower emergency room use, lower absenteeism, lower workers comp days and even lower safety risk.  And then we’ve had companies who’ve identified serious illness at an early stage when it was manageable, and they felt at the end of the day that saving a person’s life may have been the best dividend of all.  So it’s a full range, we have a lot of evidence and many of Wayne’s articles uploaded on to our website, more going on it every day, we upload about once a week to get new evidence up - but the sharing of this information and understanding that every employer will also measure their impact in a different way and one that’s valuable and meaningful to their employment - that’s why we have so many levers and so many case studies, so that people can see and where do they want to start, how we work, et cetera.

David Harlow:  So I see historically these sorts of efforts as residing with large employers and today as we sit and we observe the implosion of the federal healthcare reform efforts, I fully expect that there needs to be a shift back to the private sector, we can’t hold our breath and wait for Washington to solve our problems.  So my question along those lines are first, would you agree with that sense and second, how do you see these sorts of efforts percolating through to smaller employers?

Cyndy Nayer:  Sure, so I want to take a moment to define some of the words that you use so that we’re all talking about the same thing.  When we talk about large and small employers it really is geographically different.  And so some folks define over 10,000 as a large employer and I will tell you there are some folks that define over 100 employees as a large employer.  What we’re seeing is a huge movement across all of these sizes, and in fact the jumbos - over 10,000 - have been doing the value-based design for a while.  We’re seeing the fastest growing segments - which we normally don’t think of as employers: the cities, counties and states - which is why we had also published on our website a free downloadable white paper of five entities, public entities that have done a value based design - all very different.  Why is this the fastest growing sector?   Because everybody, in this economic implosion, is facing some sort of economic impact and at the cities, counties and states they are funded by tax dollars, and when housing prices go down and sales go down and productivity goes down, the tax dollars that go into those entities also go down, and so they are looking rapidly for amazing relief, and they are working through value-based design to get it.  The smallest companies that we’re hearing about now are right around 200 employees and we actually had this discussion at our executive board meeting this week, about: is it sustainable? and will they see the same kinds of results? and it’s about managing expectations - which is probably a really good segue back to Wayne who has some great information around this.

Wayne Burton:  Thanks Cyndy. The value really comes down to the delivery of programs, value based programs and the delivery for different size employers is going to be somewhat different.  For example, large employers very well could have an onsite nurse, nurse practitioner, doctor and other healthcare providers they can expedite things.  Historically, it would be more difficult for smaller employers - and as Cyndy said however you define that - but let’s say employers that don’t have the ability to have onsite people, health educators, and so forth to deliver these kind of services.  And all of the major plans now have programs that can be delivered - whether it be web based, coaching telephonically, web based coaching and so forth that can be done - so that I think all employers, regardless of size, have the potential of benefiting from value based designs.  

David Harlow:  And would you agree with my observation about the need for the private sector to take a greater role on this, or the state and local government agencies, because the federal government is not moving?

Wayne Burton:  I would agree David and I think historically employers have taken the lead.  Long before actually the data that we have now showing the benefit - they’ve done it because they felt it’s the right thing to do and they’ve been right.  

Cyndy Nayer:  And it’s also important David to remember that the private sector pays for better than 54% of the healthcare dollars that are spent in this country.  It’s bigger than Medicare, it’s bigger than Medicaid.  So to Wayne’s point, there have been innovations that have been going on for a lot of years - and Wayne was at the forefront of many of them - and what he has learned, what he shared, what other icons in this space have shared, have created a roadway where smaller employers, emerging employers, public entities, cities, counties and states can feel comfortable relying on their depth and breadth of information and they can move in this space without waiting for comparative effectiveness as an example.  They know that there are things they can do now to help teach their employees and their families to do better with their health.  Frankly, it’s not that we don’t have enough resources in this country, it’s really more about that we’re not using them effectively.  

David Harlow:  What do you think it would take to use them more effectively, overall? How do we leverage the resources that we have?  Is it a question of simply managing what we have, are there IT solutions that are going to help in this regard? Where are the key areas that can help?

Cyndy Nayer:  Well, IT will help, but IT only helps if the message that comes out of the technology is something that’s meaningful to the end user, and actionable.  So just providing information does not work and the reason I can say that is: I doubt that there is anyone in this country that doesn’t know that smoking is bad for them, and yet people still smoke.  So it’s not just information; it has to be meaningful and actionable.  But more importantly is teaching people.  We have a culture in this country that says, we want it all fixed right now.  Some things are not fixable right now.  Some things require time, and we understand that when we plant a garden it’s going to take a while to grow.  We understand that sometimes we have to wait for a part, we don’t understand any of that in non-emergency based healthcare and we need to learn more about prevention and wellness and do prevention and wellness instead of thinking that we can fix it when a problem happens.  There are lots of things we can do long before the problem happens.  And then how much intervention is required, and what are the outcomes that I as a patient want rather than the system wants.  Wayne?

Wayne Burton:  I agree with Cyndy and I think there is another part of health IT that has lots of potential and that’s the electronic health record.  We know that physician’s offices have good systems for making appointments and billing, but in terms of the medical record, in large part in United States today, it’s a paper based system and it is relatively difficult to have those lab results and those X-rays and other reports transmitted to other physicians, it’s a paper based kind of system.  And we are well aware of concerns about confidentiality but those can be addressed.  Clearly, the US government and part of the health reform is to put more money into health information technology for physician’s offices and others.  And I think that could be exceedingly helpful in improving the quality of care and the value of the care that we get as well as potentially patient cost.

David Harlow:  Do you see some evidence for that in the past?  Also, I have to say that at this stage in the game some of the criteria are still so undefined that it’s difficult for providers to take the sleep of faith and make the big investment.  But I guess the question is, is it your experience that these sort of health record systems or data systems do have that direct impact on outcome?

Wayne Burton:  Yes, David at corporations in their occupational medicine departments for many years, for probably 30 years they’ve had computerized record systems and what that has allowed them to do is to very efficiently have reminders to call back employees that may have high blood pressure, high cholesterol or need some follow up exam, rather than having some kind of a manual system or relying on the employee to remember to come in.  Very similar to dentists - I think dentists have done a great job over the years of getting out a reminder every 6 months he is trying to come in for teeth cleaning and so forth.  We have to take that kind of experience and get it into the healthcare system and to a large part it’s really not being done today, that’s what I mean and it will result in better outcomes.  You’re right, it is challenging for physicians and physician’s offices to do it, it’s very expensive to put in technology of that kind, it’s a learning curve and like anything else hopefully if technology evolves it will be less expensive and a lot simpler to use.  

David Harlow:  I’m interested in exploring with you just briefly how you see the work of your organization as being similar to or different from other organizations like the Leapfrog Group or Bridges To Excellence - other organizations in this space.

Cyndy Nayer:  So Leapfrog and Bridges To Excellence are doing remarkable work on the delivery side on helping us drive quality and outcomes from hospital systems or with hospital systems with provider organizations and the care continuum - people that work beyond just the provider organizations.  But there hasn’t been a space - the way we define ourselves is a safe haven and a concept studio.  It’s a place where innovation can be thought about without people saying: have you lost your ever-loving mind.  It’s a place where people share ideas and think about what would happen if … before they go over the cliff. As a matter of fact, early in our development - we only had about sixteen members at that time - one would email me and say hey, could we ping the other members and see if they’ve done anything like what I’m about to do so I can find out what kind of response rate they got and what I need to do better if I do this? - that’s the kind of place that the Center has become.  Wouldn’t you agree, Wayne? It really is a place we can all have the discussion and think about what if --.

Wayne Burton:  Absolutely, and as Cyndy said earlier, the people around the table come from all sorts of points of view – it’s not just employers, it’s not just academics, it’s not providers.  You have lots of different points of view and very, very rich discussions.  

David Harlow:  So I would like to ask both of you if you could identify two or three recent successes engendered by the by the Center and maybe two or three challenges or successes that you see when looking around the corner, trying to predict the future?

Cyndy Nayer:  Sure. I think one of our biggest successes in the past year was launching the first book that showed the road map, the levers, and the case studies that used those levers and road map, so people now had a teaching tool, they could literally open up a very easy read and find out the information that they needed and be able to show it to their CFO and say look here are other people that have done this, this is why I want to try.  So I would say that’s one of the big efforts.  The second is to, quite frankly, define this space - to talk about the levers and to change the conversation, when we talk about the levers, that we’re leveraging health, not healthcare, because once we change the word, we change the kinds of solutions that we might look at.  And so we’ve really gotten people to talk about leveraging health and what does health mean to their organization and their community, what does it mean to a person and to a family, what’s it mean to the provider networks and the health systems?  I think the third thing that I would say as a success is the validation of the work that we’ve done and that we’ve done previous to the launch of this Center in surveying the marketplace and understanding what kinds of levers were sustainable - and we’re just going to put that brand new survey - we actually commissioned Buck Consultants, which is a national health consulting firm, to work on taking our initial analysis and our initial survey and deploying it in the marketplace with companies that had a value based design in place for more than two years, and the results were stellar, the results were these.  One, everybody starts with prevention and wellness as I told you earlier.  Two, nobody succeeds without focused employee engagement and focused provider community engagement which links us then to patient centered coordinated care or patient centered medical home.  And three, that a value based design is sustainable even in an economic downturn.  What are the threats to what we’re doing?  It’s been weary these last two years in terms of the economic downturn.  So keeping people buoyed up so that they continue to move forward in what they’ve already begun and the successes they’ve achieved.  I’m sorry, Wayne, were you going to jump in?

Wayne Burton:  No, I was just - one thing that I’m excited about and the reason that I’m anxious to be part of this and glad to be part of the Center is the evaluation component, because there has been a great amount of research and great amount of work done, but with the diverse group around the table in the Center there are going to be tremendous opportunities to continue to demonstrate the value of this kind of design.

Cyndy Nayer:  Which is why we’re so glad that Wayne has come on board.

David Harlow:  Well, anything else that either of you would like to add?

Cyndy Nayer:  One of the other icons in the industry who is not on this call - and I know Wayne will be cheering with me as I say this: The Center has just created an award that’s very important, and I’d really like for folks to know about it.  It’s a multi-stakeholder community-based award and it’s named after one of the cofounders and another icon in this space, Dr.  Jack Mahoney.  I’d really like to make sure that folks know that they can apply and submit an application for the award.  It’s a pay it forward award, so it has some tricks and triggers in it.  But we really feel that the icons that are around the table, and there are many - Wayne, Jack and others - have contributed so much to what we know about improving health in America that we wanted the space where others could learn by their side and this is an opportunity for them to do that, so I’d like for folks to know about that one.

David Harlow:  Great, thank you very much.  Well, Cyndy Nayer, President of the Center for Health Value Innovation and Dr.  Wayne Burton, a member of the Board of Strategic Advisors of the Center, thank you very much for taking the time to speak with HealthBlawg.

Wayne Burton:  Thank you, David.

Cyndy Nayer:  Thank you, David.              

Transparency: Too little, too late?

When the President of the United States, allegedly possessed of the best bully pulpit in the free world, needs to go on the Super Bowl pre-game show to attract a big audience, you know that something has gone horribly, horribly wrong.

We can't solve that problem here at HealthBlawg, but perhaps we can address the issue that Obama put on the table during the pre-game show: transparency in health reform negotiations.

From the New York Times:

“I want to come back and have a large meeting, Republicans and Democrats, to go through systematically all the best ideas that are out there and move it forward,” Mr. Obama said in the interview from the White House Library.

Mr. Obama challenged Republicans to attend the meeting with their plans for lowering the cost of health insurance and expanding coverage to more than 30 million uninsured Americans. Republican leaders said they welcomed the opportunity and called on Democrats to start the debate from scratch, which the president said he would not do.

The move by Mr. Obama comes after weeks in which the administration has appeared uncertain about how to proceed on his top domestic priority since Republicans captured the Senate seat previously held by Senator Edward M. Kennedy. House and Senate Democrats had been increasingly at odds over what the bill should say, how to move ahead tactically and, in some cases, whether to continue at all.

The idea for the bipartisan meeting, set for Feb. 25, was reached in recent weeks, aides said, as part of the White House strategy to intensify its push to engage Congressional Republicans in policy negotiations, share the burden of governing and put more scrutiny on Republican initiatives.

Mr. Obama’s announcement came after he surprised his rivals in late January by requesting that a session with House Republicans be open to cameras. That meeting produced a spirited 90-minute question-and-answer session with the president that many in the White House viewed as a critical success for Mr. Obama.

In making the gesture on Sunday, Mr. Obama is in effect calling the hand of Republicans who had chastised him for not honoring a campaign pledge to hold health care deliberations in the open, broadcast by C-Span, and for not allowing Republicans at the bargaining table.

It seems to be incredibly late in the day to be extending a hand across the aisle -- and issuing a challenge at the same time -- in this way.  At the White House health care summit last fall, Obama seemed much more in control, saying, essentially, "You know what I want; send me a bill I can sign."  That seemed much more Presidential than issuing a challenge during the Super Bowl pre-game show.

The fallout from Senator Scott Brown's election is felt in this episode, as in numerous other episodes inside and outside the Beltway in the past couple of weeks, yet we really don't have a handle on Brown yet.  He could well end up being as much a thorn in the side of the GOP as Lieberman is in the side of the Democratic Party.

Pelosi's desire to turn to small bits and pieces of health care legislation seems sensible, and is consistent with the HealthBlawger's now-tired cry of "incrementalism, baby!" when it comes to health reform, but it is a far cry from the vision set forth by Candidate Obama.  There is value to getting something done, but there is also value in setting forth a vision of the future from the Oval Office.  Is Obama gearing up for another installment of Health Reform Fight Club, or does he want to get something done?  Is he going to be satisfied with the Speaker's patchwork of small steps, or will he push for a broader reform package?  Is Obama now more open to transparency in the process only because of the Scott Brown factor?  Will his strategy of "outing" Republicans as "the party of no" succeed or backfire?  Is it too late to change course, or does the American public's collective memory only go back as far as Super Sunday?

Tune in again next week . . . .

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 08, 2010

Wayne Burton and Cyndy Nayer, from the Center for Health Value Innovation, speak with David Harlow about value-based health designs for health improvement and cost savings

I recently spoke with Wayne Burton, MD and Cyndy Nayer.  Cyndy is co-founder and President of the Center for Health Value Innovation; Wayne is a member of the Board of Strategic Advisors, and former longtime Corporate Medical Director of JP Morgan Chase.  The Center focuses on sharing evidence of improved health and economic outcomes through value-based designs.  In the current environment, this sort of private-sector focus on value-based health improvement and cost savings is critical. 

Given the recent collapse of health reform inside the Beltway, now is the time for organizations such as the Center to prove themselves and their approaches, by demonstrating that they are able to "bend the cost curve" while improving health indicators, and ensure that efforts to do so yield a significant ROI.  Wayne and Cyndy shared with me a number of ways in which programs run by large employers in the public and private sectors are a step ahead of the health care systems in place for other folks.  Here's one excerpt from our conversation: 

No one succeeds in a value based design without two things.  One, an incredible focus on prevention and wellness, an expectation that people will take care of their health.  And the second is consistent and ongoing communication.  We have several instances where companies thought if they announced a value based design during benefits enrollment people would dive on to it.  And within eighteen months they had left the value based design space because it’s a complicated message and it takes a while for people to understand what exactly we want them to do.  Value based design is not just about moving copays to zero for a drug.  It really is about teaching people what part of the highway do we want them to travel on.  How do we help them get to their destination, healthier, higher performing, more productive and that’s what the levers are about.  Think of them as cones on the highway, and as we fix the highway or encounter new bumps we move the cones around to get the cars to move a different direction - that’s exactly what a lever does.

For more on the topic, check out the many articles posted on the Center's website.

The audio file of Part I of my interview with Wayne Burton and Cyndy Nayer (about 20 minutes long) is available for download/podcast.  A full transcript of Part I is at the end of this post (and in the linked Wayne Burton and Cyndy Naylor interview transcript - Part I).

Part II will be posted tomorrow.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog
Interview of Wayne Burton, MD, Member, Board of Strategic Advisors, Center for Health Value Innovation and Cyndy Nayer, Co-Founder and President Center for Health Value Innovation

Part I of II
February 5, 2010

David Harlow:  This is David Harlow on HealthBlawg and I have with me today two interesting individuals who are going to be speaking with us about value based health benefit design.  Dr.  Wayne Burton, who is a longtime Corporate Medical Director for JP Morgan Chase and has recently joined the board of strategic advisors of the Center for Health Value Innovation, which is an organization developing and sharing evidence have improved health and economic outcomes, a value based health benefit design.  Also with us today is Cyndy Nayer, a Co-Founder and President of the Center who leads the Center’s partnership with public and private sector entities using value-based design to improve outcomes.  Thank you both for being with us today.

Cyndy Nayer:  You’re welcome.

David Harlow:  I’m interested to hear, as we start, whether you could describe a little more fully, Cyndy, the work of the Center and where you see the largest impact or the greatest impact for your work these days.

Cyndy Nayer:  Sure, I’d be happy to, thank you for asking.  The Center was founded as an not for profit organization to galvanize innovative employers which would be medical directors as well as VPs of HR, human resources who are doing some very innovative things around getting the better outcomes - both economic and health outcomes - within their employee sector and showing an economic sustainability that would work but what really connected to talk to each other and accelerate the process.  As we began to recruit some of those innovators into the space, some of the health plans became very interested in what we were doing.  Now we represent a multi-stakeholder group that includes employers, private, public, not for profit as well as for profit, health plans, provider groups meaning health systems, physician organizations, single practices, employee benefits consultants.  Some folks call them brokers but many of these folks provide a much wider range of consulting expertise to their employers than just brokering insurance.  We include government entities cities, counties and states, we have several not for profit organizations with whom we have a strategic alliance and we are working quite diligently to bring about a change in the focus of the dialog, so what does that mean? When we purchase on unit cost and we use line item vetoes to hold down cost then we’re really not focused on the outcome of the patient or the worker.  When we instead focus on outcome - improved health - and understand that healthcare is the means to get to improved health, the entire dialogue changes.  And so our focus, particularly this year - and this will be our fourth year in existence, we will be focused very much on outcomes based contracting, outcomes based purchasing.  Does that help you understand what we are and where we are going?

David Harlow:  Thank you very much.  Wayne, I’d be interested in hearing from your perspective - I understand that in your role at JP Morgan Chase you’re involved in the patient centered medical home organization and I’m wondering how you see the progress of that initiative? Sort of one demonstration or pilot project among many or, I think, from the perspective of employers who have been using this approach to contracting, it’s much more than a pilot.  So I would appreciate if you could shed some light on your experience in that arena and where you see that fitting in with other initiatives that employers maybe taking today.  

Wayne Burton:  Thanks David.  Actually we were not involved in patient centered medical home demonstrations but I’m familiar with other companies that are and I believe that the key there is that providing the right care would result in better outcomes for employees and their family members and corporations, and also as Cyndy mentioned, to have sustainability in their cost trends, lesser absenteeism and a more productive workforce.

David Harlow:  And do you see other particular types of efforts as being particularly promising or productive today?

Wayne Burton:  Yes, I do.  The efforts really across the country with looking at outcomes, looking at evidence-based medicine - and one of the hats I wear now is Co-Chair of the National Committee on Evidence-Based Medicine for the National Business Group on Health - is really fostering evidence-based medicine amongst employers and plans and clearly there are many, many efforts going on in that regard.  But if we follow the guidelines and latest treatment guidelines that’s going to result in better outcomes, and for corporations, employees are going to be in better health, more productive and use less disability time.  

David Harlow:  Do you see an evolution over time in the development of protocols through evidence-based medicine because historically there has been a lot of objection to the notion of “cookbook medicine” by some frontline providers, and I’m wondering how you respond to that?

Wayne Burton:  Well, David, you’re right, and I’m a physician and an internist and so I’m aware of the concern amongst providers about so-called cookbook medicine.  Part of the concern is the different guidelines that are out there and different rules and there are a number of efforts now across the country for groups to get together and have common guidelines and common metrics to measure - specifically by the major health plans - because the providers, if they are trying to abide by different rules, it’s very difficult knowing which rules they are going to be rewarded for, so to speak, in one plan versus another.  The other point that you make, and it’s an important one, is we certainly don’t want to see cookbook medicine. Evidence-based medicine means doing the right thing for patients realizing there is variation, and realizing that treatment does have to be modified based on the particular patient, the particular medical conditions and comorbidities and so forth.

Cyndy Nayer:  So David if I could amplify what Wayne is saying and also do a little bit of the background on Wayne so that everybody knows that the JP Morgan Chase Medical Directorship is certainly one of the hats that he wears, but Wayne has been diligently cataloging and publishing and researching the connectivity between poor health, disability days (defined as workers comp or unscheduled absence), comorbid conditions - for instance, people who have depression typically don’t manage their other health conditions very well if the depression is not managed well.  These are the kinds of research and calls to action that Wayne has made a career of, and that’s one of the reasons we’re so excited to have him on board because he kind of rounds out a lot of the work that we’re doing.  Having said that, and to his point of evidence-based medicine - not using that as a cookbook, but really just as a starting point as the concept of treating and triaging patients and workers and families has grown and the amount of information that we know about managing health is exponentially larger than what we do 5 to 10 years ago and will continue to grow.  Evidence-based guidelines, evidence-based medicine give us a place to start that changes the variability between practice patterns.  So it says first start here, and once you see that doesn’t work or once you have at least considered this guideline - then again, putting your patient first, not the guideline first, the patient first - think about what you might want to massage, change, do better for that patient.  And most of us will do better close to an evidence-based guideline, but there are also many of us that will not, for a variety of reasons.  And human beings are human beings because we are different by nature and different by how we approach our health management.  For all of those reasons, what Wayne has said and the work that Wayne has done supports and amplifies the whole concept and focus on outcomes.  So the evidence-based platform is where you start, but what we really want to see are communities of health.  And that’s what an employer wants as well, because when we have healthy workers, we also have healthy purchasers and we have healthy users who make appropriate decisions of the kinds of healthcare that they will use as well as the kinds of other products that they will use in a community and that’s part of the sustainability factor of America.  That’s really it’s a big picture but it’s about seeing how we might do it more efficiently and quite frankly more innovatively which is what we’re known for.

David Harlow:  Sure.  Now at what points in the process in terms of designing and implementing these approaches are you also doing measurement to ensure that there is a significant impact?

Wayne Burton:  David, I think there are at least two ways we are approaching it.  Ideally, you’re designing the outcomes measures at the start of a particular program or intervention and that’s best of all possible worlds, but we realize that in many cases that’s not always possible.  So that much of the very good research now is taking a look back at what had been done, carefully analyzing the data that’s available and then seeing the effect of a particular intervention.

David Harlow:  And have you collectively been at this long enough to be making changes to the approaches based on the measurements and outcomes observed?

Wayne Burton:  From the employer side I’ve been involved in it for over 25 years.  And so we had the opportunity to look at programs prospectively.  For example, a lot of our work has been done at the work site where we have interventions for diabetes and asthma and migraine headache and prospectively we look at how these educational programs and disease management kind of programs have impacted the health and well being of our employees that participated - including they have economic impact - but as Cyndy said our role is to first show that that can improve the health of our employees and if you improve the health then the cost will follow.  Secondly, we’ve looked at really thousands of workers as we put in programs like wellness programs that can address health risk and we know now from a lots and lots of research, our own and many others, that if health risks are modified through lifestyle programs and other interventions that with those reduced health risks that healthcare cost trends will modify, that there will be less absenteeism, and in fact now we know from the past several years there is improved on the job productivity – so-called presenteeism.

David Harlow:  Presenteeism, I like that.  One thing that I’ve read in your materials is the notion that there are different levers that you can use to effect these outcomes and you’ve identified them as sort of falling into different categories or different employers maybe at different stages of readiness to employ different approaches.  And you mentioned a moment ago the notion that there are a million different measures that people are called upon to report on.  And I think the same question arises in terms of the proliferation of different types of interventions that can be taken as well.  I often ask people whether we could limit ourselves to a dozen or so outcome measures rather than measuring a couple hundred or thousand different outcome measures and the same goes really on the input side, on these levers. Can we legitimately limit ourselves to a couple dozen levers to manipulate in order to achieve some beneficial outcomes?  The more levers we have and the more measures we’re trying to follow, the more complicated it becomes the more unadministrable it becomes from my perspective.

Cyndy Nayer:  You’re incredibly correct.  You have no idea of how correct you are, which is why we took 107 levers and rolled them up into basically 15 macros levers but even the macro levers are changing as we’re talking right now, they are dynamic.  So I think the major focus is to stay on the 3 domains of the levers and understand that innovative employers, innovative health plans will add levers as we learn more.  So the three domains are these: prevention and wellness, chronic care management and individual health competency.  The last one is a little tricky, so what that means is: how do we teach people to manage their health effectively and link it to both their wealth and performance and these are on a continuum, no one ever deploys only one value based design lever, they are always part of a suite. They are always determined by the state of urgency and sophistication of that employer at that moment when they start and no one succeeds in a value based design without two things.  One, an incredible focus on prevention and wellness, an expectation that people will take care of their health.  And the second is consistent and ongoing communication.  We have several instances where companies thought if they announced a value based design during benefits enrollment people would dive on to it.  And within eighteen months they had left the value based design space because it’s a complicated message and it takes a while for people to understand what exactly we want them to do.  Value based design is not just about moving copays to zero for a drug.  It really is about teaching people what part of the highway do we want them to travel on.  How do we help them get to their destination, healthier, higher performing, more productive and that’s what the levers are about.  Think of them as cones on the highway, and as we fix the highway or encounter new bumps we move the cones around to get the cars to move a different direction - that’s exactly what a lever does.

David Harlow:  So give us an example or several examples of levers, are these financial incentives or these what are they?

Cyndy Nayer:  So the iconic moment is financial incentives, you’re incredibly correct.  The early pioneers, Pitney, City of Asheville did use copay incentives.  But sometimes there are others that use a variety of other incentives.  I can give you a couple and I know Wayne can give you many more.  One example is teaching people to use their personal health record and lowering their insurance premium because they do use their personal health record.  Now, why would people, why would a company do that?  Because in order to create sustainable behavior change, people have to manage to a goal.  Teaching them to use their personal health record teaches them to manage to a goal.  Having folks get their flu shot when they have cardiovascular disease or diabetes, and bringing the flu shot on site and if you get it on site giving it to them at a waived copay or low out of pocket expense, that’s another kind of a lever.  You get the idea, some of them are financial but some of them are really messaging and communication.  Wayne, do you want to add to that?

Wayne Burton:  Yes, and David, I think one of the questions you brought up is important for corporations - what the focus on in terms of design of wellness programs - and it turns out that for employees if they complete a health risk appraisal and if the health risk appraisal asks questions about medical conditions and health risks and usually it takes at most ten or fifteen minutes to answer those questions.  It’s a extremely powerful tool to guide the employee and to guide the company in terms of what program should be necessary - and actually, of the health risks there are probably a dozen or less for most corporations that are important, and certainly health risks such as smoking, physical activity and weight are probably at the top of the list for most companies in terms of risk to many individuals.  In terms of medical conditions, similarly, yes there is a whole long list of medical conditions that could be addressed.  For most companies especially in the United States, in the service industry, for many workers, pregnancy and mental health is usually in the top five or top three conditions, musculoskeletal disorders of one sort or another - probably back pain is one of the most common.  So, yes, there are lots and lots of conditions and outcomes that could be focused on in prevention programs, but at the end of the day most companies can focus on a relatively small number and reach the majority of their employees and family members. 

February 07, 2010

Medical Apologies: Do right and do well

An often overlooked tool in health care providers' struggle with the malpractice crisis is the medical apology.  Two thirds of the states provide some form of protection for the medical apology (i.e., a simple apology is not admissible in court as an admission of culpability), and settlements reached post-apology are almost invariably lower that they would be otherwise.  (In the current environment, articles on medical apologies are popping up everywhere ... even in the NY Times business section.)

It is important to note that an effective apology policy does not stop with the simple apology -- I'm sorry that this happened to you -- but must include a commitment to conduct a root cause analysis, to communicate the results to the patient and/or patient's family, to implement systems improvements based on the results of the root cause analysis, and to offer a specific apology once the analysis is complete, and an offer of monetary compensation if the provider or its systems were at fault.  Of course, it's easier to describe these steps than to actually carry them out.  Providers who plan in advance, who adopt policies and procedures, and who are trained in the implementation of a medical apology policy, can see dramatic results.  Smaller provider organizations may need outside resources to conduct root cause analyses; engaging these resources will frequently prove beneficial in the long run in terms of reduced settlement costs and avoidance of future issues. 

Often, following a bad outcome, a patient's family member may wonder if he or she could have done something different to prevent the bad outcome, and the analysis can serve to put his or her mind at ease.  In addition, patients and family members often sue because they want to be sure that "nothing like this ever happens to anyone else."  If a provider can demonstrate that a root cause analysis has been done and systems improvements made so that the same mistakes cannot be repeated, then that impetus for filing suit is removed.

I was quoted in an article on medical apologies in a recent edition of American Medical News, suggesting that "preventive law" serves as a worthy complement to "preventive medicine."  This piece serves as a good review of the issue and highlights some good resources, including successful medical apologies programs.  For example, the University of Michigan health system reduced malpractice payouts by about 50% following implementation of its program.  Other examples of successful programs abound.  (And here's another resource on medical apologies.)

Many continue to work and hope for comprehensive malpractice reform.  With health reform likely off the table for now -- and malpractice reform not ever really a part of that legislative effort -- the action needs to shift away from hoped-for legislative relief.  In light of the potential for a new trend in elimination of damage caps -- witness the recent Illinois case -- providers need to think about alternative approaches to reducing that risk.  Medical apologies programs -- in addition to the psychic benefit they offer to both providers and patients -- have proven to be effective in that regard in most states.

For provider organizations of all shapes and sizes, the HealthBlawger's multidisciplinary team offers a suite of education, planning, training and tracking services to aid in the development and implementation of a medical apologies program.           

David Harlow
The Harlow Group LLC
Health Care Law and Consulting