The Playbook For Medical Innovation Success (and a great example)

Along with co-authors Robert Epstein, Jean-Pierre Lehner and Tehseen Salimi, the unrelenting Disease Management Care Blog has penned yet another peer-reviewed article (on page 9 here), this time in the newly established Journal of Comparative Effectiveness Research.  While the title "Integrating Scientific and Real-World Evidence Within and Beyond the Drug Development Process" speaks to the development of pharmaceuticals, the DMCB humbly submits that the article's lessons can be applied to any medical innovation.  That includes not only medical devices but population-based disease and care management, the Patient Centered Medical Home, value-based purchasing, ACOs and bundled payments.

The DMCB argues that in order for medical innovations to succeed, there has to be a readily identifiable value proposition. The challenge for innovators is that this perception of "value" varies greatly between patients, physicians, payers and government.  Meeting the expectations of these disparate stakeholders means creating a three phase process of integrating clinical data, economic information, patient centered outcomes, population-based and observational real-world evidence obtained from networks, communities, countries and populations:  

1) The Definition Phase: understand unmet needs and catalog how any potential benefits will meet those needs.

2) The Generation Phase:  formulate and validate the benefits by collecting the information that spans population health science, clinical epidemiology, economic modeling, patient reported outcomes, econometric studies, clinical trials and observational data bases.

3) The Translation Phase: establish the benefits from the very outset of any implementation through continuous monitoring and updating of any and all outcomes data for an increasingly sophisticated marketplace.

What ingredients are necessary to sustain the three phases?

1) Informatics that aggregate qualitative and quantitative analyses that include not only all that traditional research but spans meta-analyses, public databases, insurance networks and social networks that integrate patient, provider and payer insights.  This has to evolve in tandem with shifting market conditions;

2) An on-line and highly accessible intelligence repository that functions simultaneously as a database, library and registry;

3) A dossier that catalogs all quantitative and qualitative assessments that build the clinical and economic case for coverage and reimbursement;

4) High performing and interdependent expert teams that can interact with multiple stakeholders.

The DMCB thinks that the success of the Patient Centered Primary Care Collaborative can be credited to following this playbook.  Click around its web site and it's patently obvious that this coalition has worked to align the vision of transformed primary care with society's unmet needs, have prospectively collected any and all study outcomes and are continuously monitoring its impact in the real world.  Their PCPCC web site is a target rich collection of informatics, databases, dossiers and teams.

Comparative Effectiveness Research Update: Greater Flexibility, More Outcomes

For an update on how the folks who are in charge of the $1.1 billion's worth of "comparative effectiveness research" (CER) are viewing the world, the Disease Management Care Blog checked out this just-published online Perspective piece in the latest New England Journal of Medicine. 

Study Subjects With Combinations of Conditions

While the focus will be on persons with chronic physical and mental health conditions, the real challenge for the "Patient-Centered Outcomes Research Institute" (PCORI) will be to find the right combinations of conditions (for example, persons with coronary artery disease with advanced heart failure plus depression) in sufficient numbers of individuals that will allow statistically valid inferences to be made. 

Alternative Research Methodologies

While PCORI would have preferred to use prospective randomized clinical trials to conduct their research, they must have been listening to critics like the Disease Management Care Blog.  There aren't enough patients, enough time or enough money within reach.  As a result, PCORI now recognizes that "observational studies" on heterogeneous patients outside the rarefied world of academia - despite the twin threats of confounding and bias - have to be included in the mix of funded study designs.  It turns out that it's possible if statistical controls are carefully and judiciously applied.  This will be considerably easier if large "registries" (or databases) are developed that contain the longitudinal outcomes data of large cohorts of patients.

What Outcomes?

The article also points out that untangling various outcomes involving multiple co-morbid disease states promises to be thorny, especially since treatments that help one condition (high blood pressure) may exacerbate another (low blood pressure and falls in a person with osteoporosis).  The answer will be to find outcomes that can be universally applied across multiple disease states such as "shortness of breath" or overall "quality of life."

The DMCB Reaction

"Hear hear!" says the DMCB.  This latest update indicates the folks in PCORI have recognized that good research methodologies shouldn't be the enemy of the perfect.  They have come to realize what the population health management community realized years ago: that it's possible to simultaneously provide care and intertwine robust research methods that simultaneously render insights about the population under management.

And... Uh Oh!

Unfortunately, the PCORI is widely viewed by supporters and critics as emblematic of "Obamacare" and there are threats by the ACA-hostile Republicans to defund it.  It remains to be seen how likely this is to succeed, but in the meantime the PCORI could help its cause by supporting the location of CER outside the usual insular academic institutions.  For example, it could be done in a commercial disease management setting, where huge amounts of data on millions with chronic conditions are already having their longitudinal data followed in huge terrabye servers (for example is here).

Comparative Effectiveness Research: How We Could Make It Effective

Yesterday's Disease Management Care Blog post on the impact of physician professional autonomy in health reform generated some readership consternation, including some personal feedback that it must have been written after a recent excess of additional research in this topic area.

Not true, says the DMCB. But it thinks the same charge could be leveled at the authors of this utopian viewpoint on the topic Comparative Effectiveness Research (CER) that recently appeared as a Commentary in the Amercian Journal of Managed Care.

According to Dr. Sox et al, CER will usher in a new age of enlightened medicine in the United States, enabling it to join other civilized nations with the means to scientifically assess every corner of health care. Those means are two fold: 1) money printing presses that finance the research and 2) experts to assess that research and make recommendations. As a result, policy makers will be informed, uncertainties will wane and patients and physicans will choose wisely. Medical Journals that recognize this will be doing their part to make a healthier and happier world.

In order for this supposed nirvana of knowledge, this cornucopia of comprehension, this era of excellence to occur, however, the CER will need to be scientific, conducted under protocol, use representative populations, registered, peer reviewed, open accessed, published in traditional upper tier journals and be accompanied by descriptions of the research limitations and disclosures of author conflict of interest.

The problem? The DMCB notes plenty of research is already subject to protocol, representative, peer reviewed, open accessed, published and transparent. More of the same, thanks to $1.1 billion, isn't any more likely than the current system to sigificantly influence physicians. Case in point is the CER poster child ALLHAT Study (also detailed in the prior post) that met all the CER criteria favored by Cox et al and still failed after publication in JAMA to increase water pill prescribing vs. other more expensive medications for hypertension.

What CER really represents is a 10 figure gravy train for the academic-medical-publishing industrial complex courtesy of the U.S. taxpayers. There will be some benefit, thinks the DMCB, but it doubts we're going to get our money's worth.

Fortunately, the DMCB has some additional suggestions that will help increase the odds that CER could actually have an impact:

1) the research protocols should be explicitly translational. In other words, the interventions that are being tested should include features that help us understand how they can be best disseminated into mainstream care settings. For example, ALLHAT could have included a thiazide plus disease management/value-based insurance design treatment arm. It's not only important to understand what but how.

2) the outcomes should not only appear in traditional medical journal "channels," but be actively and freely disseminated in nontraditional venues used by health care professionals as well as consumers, including, but not limited to, on-line web sites, discussion boards, blogs and other social media. There should be a routine methodology to deconstruct the complex outcomes results into language that can be accessed and understood by lay persons. A good start is the Annals of Internal Medicine's patient information section.

3) speaking of lay persons, it's not enough to "open access" the summary results of CER. The individual level data itself - within the limits of current interpretations of the need to respect privacy - should be open sourced. There are plenty of lay scientists with the skill and the interest to look for and find problems that may have been missed by the authors, reviewers and editors. An example is the initially missed excess number of heart attacks among Vioxx users in this paper that was published in the New England Journal.

4) candidacy for research funding should not be limited to traditional members of the academic community with a track record, but favor initiatives that involve partnerships that include, but are not limited to, community and faith-based organizations, health insurers, purchasers, buyers and patient advocacy groups like this.

More Transparency Is Needed on Comparative Effectiveness Research

During the last of the Federal Coordinating Council for Comparative Effectiveness Research’s “listening sessions,” the folks from the Population Health Impact Institute (PHII), in partnership with ABQAURP, AHIMA, CMSA, and IHPM, advocated on behalf of better transparency of Federally funded comparative effectiveness research (CER). Its statement argues that consumers of the information need to be able to assess the merits of any and all conclusions that purport to show that one treatment approach is truly better than another. They also pushed the idea that researchers who accept CER funding should sign a transparency pledge and supported reimbursing experts who perform ‘peer review.’ You can listen in on all the proceedings here. Don't take the DMCB's word on how this is noteworthy. The PHII comments gained some national press coverage here and here

The Disease Management Care Blog agrees these are all good ideas. Here’s why:

Open up any medical-scientific journal and you, along with the majority of other readers, will be tempted to skip past the ‘methods’ section, scan the results and jump right to the conclusions. So will much of the media. However, if the topic is really important to you, your patients or your business, the methods may be the most important art of the mansucript. As a rule of thumb, if the DMCB doesn’t understand the methods section because it is lengthy and littered with complex jargon that involves combined/irrelevant endpoints involving subgroups and strained comparisons, it generaly believes the results are suspect and moves onto the next article. PHII’s recommendations, if carried out, could go a long way toward reassuring readers of CER that complex methods aren’t being used to obscure weaknesses in the conclusions.

As we know, strings are being attached to other sources of Federal funding. If it is good enough for business and finance, it is certainly good enough for health-related research. PHII thinks any researcher should be willing to put their pledge where his or her month is. In fact, PHII is perfect organization to offer such a pledge document.

All the ‘peer review’ medical-scientific journals maintain a bullpen of ‘go to’ clinicians/scientists/researchers who agree to read submitted manuscripts that are being considered for publication. The DMCB has served as a peer reviewer for a number of top flight journals and it can be a tedious task: the writing is seldom polished and the conclusions are often not valid. As a result, it's often up to the peer reviewers to serve as an ‘outsourced’ editorial staff to help correct the English and point out the flaws in the underlying science. Peer reviewers generally agree to do this because its flattering to be asked to do it, breaking information is available before it makes it to print, it makes for good ballast on a CV or resume and sometimes it leads to being asked to write an editorial. However, ultimately, reviewers typically do this on their own dime and some may not give their reviews the attention they deserve. PHII argues its time for the peer review process – and that part of the U.S. economy devoted to health care - to get what it pays for.

As noted in prior posts, the DMCB would go one step further and go ‘open source’ on CER. Publicly funded research should generate publicly available data. Ultimately, anyone should be able to download the data and - assuming they adhere to privacy standards and use deidentified data - keep the original researchers and their conclusions honest. Who knows, they may find something that was missed. If no one can attack the integrity of the original data, the federal sponsors of CER will be that more confident that the conclusions are valid.

A Grumpy View of Comparative Effectiveness Research: What You Won't Read in the New England Journal of Medicine

The Disease Management Care Blog found three predictable articles on comparative effectiveness research (CER) in the latest [May 17 Volume 360 (19)] New England Journal of Medicine. You’ll need a subscription to read them. Don’t have one? Don't have the time? Well, thanks to the DMCB you don't have a problem, because there is a brief one paragraph summary on each:

The first is written by Alan Garber, from the Center for Health Policy at Stanford University and Sean Tunis of the Center for Medical Technology Policy. They address the criticism ‘of some’ that CER will be unable to account for individual patient differences. This will stymie the kind of personalized medicine (PM) that uses (for example) age, co-existing conditions, individual preferences and other variables to that can be used to tailor therapy. Using genomic testing as one arena where CER and PM might clash, they reassure readers that trials on the use of genetic testing have helped patients and physicians better understand when they do and do not help guide therapy with a high level of granularity. More trials built on this kind of success should help better inform these kinds of issues, especially if they are paired from the insights possible from large observational databases.

The second is by Jerry Avorn of Harvard. Funding CER at a level of 1/20th of 1% of our annual healthcare spend doesn’t seem unreasonable to him. What is unreasonable are opponents to CER who are cloaking themselves in moral and policy ‘nonfacts,’ falsely warning in Orwellian tones about government intrusions into the doctor-patient relationship, cookbook medicine and rationing. Thanks goodness Congress resisted those nutcases. He asks our just citizenry of righteous persuasion to remain focused on the task and not be distracted by continued disinformation.

Aanand Naik and Laura Petersen of Baylor ask if CER will lead to better care. They are optimistic it will, because there are some examples of the rapid translation of clinical research into mainstream practice. One is the time for heart attack victims to go from the emergency room door to percutaneous coronary intervention (PCI). They note this success was based on an emerging ‘implementation science’ that included the dissemination of tool kits. They advocate that CER include the creation of ‘connections’ between researchers and practitioners that go from the science of recommendation to the science of implementation.

The curmudgeonly DMCB agrees with all of these guys. It is not a Grumpy nutcase and it is not being defensive. Nonetheless, some reasonable skepticism about CER may be warranted:

No one has done CER on CER: While the door-to-PCI anecdote is a good example of how well things can work, the DMCB recalls the tool kits were ultimately disseminated by the American College of Cardiology without the help of the Feds. Given the ‘unknown unknowns’ about the execution of CER as currently envisioned and its impact on day-to-day practice, the DMCB wonders if the oppositionally-minded Trogdolyte opponents of CER really need to worry all that much.

Minimizes other research by industry: While 1/20th of 1% of comparatively small, it is comparatively huge versus the budget previously devoted to clinical research by other entities, including employers and disease management organizations. As a result, other worthwhile science may wither on the vine in the rush to get a piece of this new Federal largess or be pushed aside, even if the concepts or findings are useful. As was pointed out in The Age of the Unthinkable, real breakthroughs are thanks to mavericks working outside the funding mainstream. CER could crush them and it certainly won't help them.

There are the means and then there are the tails: Critics of research that ultimately compares an outcome based on a better average value in an intervention group compared to an average value in the comparison group have a point. Clinical research is based on the clustering of detectable patient outcomes around the mean, while smaller numbers of patients in both groups may get a lot better or worse. While the authors in the New England Journal assure us that subgroup analyses will help spot the outliers, the DMCB isn’t so sure. For example, what is the optimum level of blood glucose control in a Type 1 diabetic night-time truck driver with post-traumatic stress disorder who won’t take his blood pressure pills?

Will never assume a high level of confidence, only high probability: Comparative effectiveness research implies a degree of confident scientific certainty that has served medicine’s branding for decades. The fact is, however, that CER is only as good as the last published study. It represents the most recent estimate of a likelihood that a treatment is better and, like the promise to fix the SGR, is subject to change at anytime.

Rapid, efficient or relevant? Hardly. It takes months to even plan large multi-site clinical trials, years to recruit patients and collect the data and even more time to analyze it. By the time we begin to see any good results, there will not only be new untested treatment options but the Republicans will be in charge.

Information monopoly: Care to guess who will be the greatest beneficiaries of CER? Academics in our largest and bestest medical institutions will build on their pattern of getting the lion’s share of the funding, designing the research and releasing the data in the same old hidebound ways. That style will continue to inform policy at the Federal level, which will lead to more programs that continue to feed the tertiary academic medical-industrial complex. And as an aside, it will perpetuate the New England Journal’s business model. No wonder they neglected to have that 4th article that presented a contrary point of view.

FCCCER: An Unfortunate Acronym. Hopefully, It Won't Stick

There they go again. Invective. Hyperbole. Partisanship. Un-niceness.

Read this editorial and you’d get the impression that the Feds are using health care as a Trojan horse to strip us of our freedoms. Listen to this guy and you may want to don your war paint and dump some tea into Boston’s Harbor. No… wait! It’s the other side that’s evil. They’re vicious, ignorant fear mongers who should just sit down and shut up. Because, this is Good and Righteous. It's Very Good.

And so it begins.

What’s got everyone so riled up? ‘Comparative effectiveness research’ and the ‘health council.’ Confused, the DMCB went to the original language of the stimulus bill (p. 63 of this 407 page behemoth) and found language that states $1.1 billion will go to the National Institutes of Health (NIH) and the Secretary of Health and Human Services for ‘comparative effectiveness research’ that measures ‘clinical outcomes, effectiveness and appropriateness’ of ‘items, services and procedures that are used to prevent, diagnose or treat.’ The money can also be directed to encourage the use of registries, clinical data networks and electronic health data that can be used for outcomes data. The money can be granted to ‘appropriate public and private entities.’ $1.5 million is allocated to the Institute of Medicine to decide on priorities for the research.

There will also be a ‘Federal Coordinating Council for Comparative Effectiveness Research’ (FCCCER) (page 73) which will be made up of 15 individuals who ‘foster’ coordination of the research as well as advise, assist and report. This Council will not be allowed to mandate coverage, reimbursement, or other policies for any public or private payers such as clinical guidelines for payment, coverage or treatment.

Like factcheck.org, the DMCB is not worried. But it’s not all that impressed either. Here’s why:

In its days as a managed care medical director, we were constantly scouring the peer-reviewed medical literature to help us divine insurance coverage decisions. We found no matter how carefully crafted, even the best studies leave unanswered questions and are riddled with exceptions. Recent case in point? The rigorously performed SYNTAX trial, which found open surgery bypass had better outcomes compared to the use of stents among persons with severe coronary artery disease. You’d think case closed until you read how these two experts differed in their interpretation of the findings. What they agreed most strongly on was the need for more research. More research begets more research.

In addition, the DMCB isn’t sure that the current insular medical-industrial complex is prepared to conduct the kind of comparative research we need today. We need speed, we need community-based studies, we need to simultaneously implement promising interventions and we need to ask not only ‘if’ it worked but ‘how’ and ‘why’ and for who and under what special circumstances. It’s not just the DMCB that feels that way.

What’s more, clinical effectiveness research won’t answer many important questions – even if money isn’t an issue and even if everyone in Washington DC would like to ethically advance cost effectiveness. Should hundreds of thousands of dollars be spent to prolong the life of an elderly man with advanced brain cancer? What should ICU physicians do in the face of overwhelming but not absolute odds of dying? Is State by State variation due to physicians and is it necessarily bad? Even if we know something doesn’t work, would we still pay for it?

And how about FCCCER? Assuming ‘advise’ and ‘assist’ and ‘report’ are really action verbs, does it have any hope of navigating through the hugely bloated DC bureaucracy? Note that many of its members will be from AHRQ, CMS, NIH, FDA and the VA. Think members of Congress won’t be calling them on behalf of their constituencies? Think again.

Last but not least, FCCCER is an unfortunate acronym. Quite.

Summary: It’ll take years before results appear from traditionally conducted effectiveness research. It won’t answer the important questions. Medical directors will still need to use clinical judgment in deciding coverage issues. It’s not a Trojan Horse and it’s not a panacea. Hopefully, if it has any negative impact, my medical colleagues won't use their own FCCCER-like action verbs to describe its performance.

Talk About Value - A Webinar on Comparative Effectiveness and It's Free

The Disease Management Care Blog modestly announces it will be a speaker at an upcoming webinar December 18 at 2 PM EST. The discussion will focus on the hot topic of 'comparative effectiveness,' which underlies many of the principles being espoused by the Population Health Impact Institute. While that is good news indeed, the better news is that you'll get to hear even savvier experts, including:

Joel V. Brill, MD, Chief Medical Officer, Predictive Health
Vicki Darlington, Wellness Director, Entergy Corporation
Richard Hodach, MD, PhD, Population Health Consultant
Thomas Wilson, PhD, Epidemiologist, Trajectory Healthcare

The DMCB thinks that when you are done listening to this, you will have the qualifications necessary to serve on the former Senator Daschle's Health Fed Board. Why not? Better you than someone from the Commonwealth Fund.

By the way, it's free. Register here. Your CFO will thank you for knowing value when you see it.

It's Not Just the Costs, Stupid, It's the Technology. Insight from the Robert Wood Johnson Foundation

When the Disease Management Care Blog gets an email from the Robert Wood Johnson Foundation, it pays attention. Heck, maybe it is just an internet version of junk mail, but it still makes the DMCB feel good and it’s testimony to how RWJ is correctly paying attention to us bloggers. Are we the internet’s chattering version of AM radio talk shows, or do we perform an important service by providing insight not available elsewhere? RWJ (and Kaiser, by the way) seem to think it’s the latter.

What newsworthy morsel would prompt the RWJ to virtually reach out and touch the DMCB you ask? Paul Ginsburg, President of the Center for Studying Health System Change has authored a report on ‘High and rising health care costs: demystifying U.S. health care spending’ that is posted on the RWJ site. The piece is a well written literature review with no new insights. The good news is that those insights are repackaged with emphasis on all the right places.

There is much to digest here, but the DMCB zeroed in Dr. Ginsberg’s views on the impact of technology. This is the number one driver of cost and includes things like new types of gadgets (e.g., heart catheters for angioplasty), approaches to surgery (e.g., robotic), imaging (e.g., PET scans), monitoring devices (e.g., continuous glucose monitoring for Type 1 diabetes) and pharmaceuticals (biologics). Dr. Ginsberg correctly points out that not all technologic advances are of equal value, but that’s not the problem. The problem is that technology that is intended to be substitutive (that replaces open heart surgery, open prostate surgery, regular x-rays, blood tests and pills) often ends up being additional or expansive (patients who wouldn’t have had open heart surgeries can now get angioplasties, men who would opt to not have prostate surgery agree to robotic, PETs and all the other x-rays are done together and all persons with Type 1 diabetes end up being potential candidates for CGM).

Dr. Ginsberg offers up three options for your consideration:

1. Effectiveness research that separates the wheat from the chaff. He notes this means not only shielding the research from unseemly political or industry pressure to jigger its assessments, but using that tedious, obscure and dreaded metric that has been demystified in a prior DMCB post, the ‘QALY.’

2. Payment reform that puts the brakes on the morphing of substitutive into additive technologies. He notes that the profit margins on angioplasties, robotic surgery, PET scans, continuous glucose monitoring and biologics can be reduced by enlightened fee schedules that make it less attractive to go to market.

3. Consumerism with incentives and support that enable individual patients to avoid new low value technology in favor of the good old stuff or truly valuable new stuff. Think transparency, changes in the tax code, cost sharing, and altering the insurance benefit to cover care that has a low ratio of dollars to QALYs.

The DMCB offers up three thoughts for your consideration:

1. The DMCB has given many Grand Rounds, taught many young physicians, talked to many policy makers and quaffed brewskis with many captains of industry. It can say with great certainty that 99% have idea none what a QALY is or how to apply it in the day to day business of healthcare. That’s not necessarily insurmountable, but it speaks to the specter of a priestly class of Brahmin healthcare economists using a functionally opaque methodology to decide if little Johnny can get cancer treatment. The DMCB gives the idea a ‘C’ grade and advice to proceed with caution.

2. Through much of its career, the DMCB has parked its primary care Toyota next to its specialist colleagues’ Caddies in the doctor’s parking lot, but isn’t resentful. However, it’s not sure making the specialists drive Tato Nanos is necessarily the best answer. Rather, the DMCB remains partial to Porter and Teisberg’s ideas on global payments for episodes of care (a.k.a, conditions and care cycles), which go unmentioned by Dr. Ginsberg; it thinks the docs can sort things out for themselves under such an approach. A ‘D’ grade for not recognizing the merits of others' approaches.

3. What is more valuable than an informed, savvy patient that understands the benefits, risks, alternatives and costs of all the various testing and treatment options? The DMCB would like to point out, however, that provider ‘framing,’ thanks to conscious or unconscious bias, is an under-recognized driver in patient decision making and that there is a huge science on the topic outside the mainstream of medicine. A B+ which would have been an ‘A’ if disease management had been mentioned.

By the way, the DMCB expresses its gratitude to RWJ for the email and for making its report available on line. It would also like to point out that the RWJ is hosting a webinar on Friday, Nov. 14th from 1:00 to 2:30 to discuss this paper and health care costs. In addition to Dr. Ginsburg, David Nexon from AdvaMed and Helen Darling from the National Business Group on Health will provide comments. You can register by e-mailing egarland@gymr.com.

The DMCB Comments About Comparative Effectiveness Research, Payment for Quality, Measuring Resource Use & Physician Payment

The Disease Management Care Blog participated in an interview about some of The Big Medical Questions Of Our Time and, in typical media fashion, adhered to a superficial‘ drive-by shooting’ approach in its responses. This is less about accuracy or thoroughness but more about covering as wide an area as possible and then exiting quickly. So here’s the short and sweet of it:

What is the role of Comparative Effectiveness Research?

It’s suitable for drugs, devices and relatively circumscribed medical interventions. In the CER universe, an academic/research medical-industrial complex approach of head-to-head randomized clinical trials will be a virtue. That’s fine, but the DMCB doubts complex ‘packages’ of interventions that are interdependent and synergistic (like the Medical Home or Disease Management) lend themselves too well to prospective trials because they are hard to randomize, hard to blind, difficult to shield from other sources of bias and certainly hard to pay for.

The key question for readers of the DMCB: If CER determines there is no evidence that an intervention “works,” should that result in 1) no payment, because there is no evidence, or 2) payment until there is evidence that something else works better?

What is the role of Linking Payment to Quality?

While this has yet to really be applied to physicians, in order to discern levels of clinical quality ('high,' warranting payment, versus 'low,' warranting non-payment), the ‘law of large numbers’ requires that a valid statistical sample be used. Most individual physicians in most practice settings don’t have sufficient numbers of patients with a condition in which quality can be confidently assessed. This is an insurmountable problem, unless the solution is “close” is good enough. By the way, even if a sufficiently large sample becomes available, a p value of .05, means 5% of the payments are probably in error.

The key question for readers of the DMCB: A common solution is to aggregate physicians’ data and let the physicians distribute the payment. Is this a conscious or unconscious early step in the aggregation of physicians into groups, PHOs, accountable health systems or integrated health systems – and the demise of the small independent practice?

What is the role of Measuring Resource Use?

Since the subsequent use of resources (back imaging studies and a visit to a specialist or hospital) following an index encounter (the first visit for back pain) is part of the resource consumption, most measures of resource use rely on ‘episodes of care,” which the DMCB thinks of as a packaged timeline with a start (index visit) and a finish (resolution of the condition). The good news is that otherwise independent providers involved in the episode of care can have a stake in optimizing resource use. The measures, if done right, can get them to cooperate and integrate.

The key question for readers of the DMCB: Is measuring resource use around an episode of care the first step in a road that will lead to paying for episodes of care, using a payment mechanism similar to capitation?

What is the role of Medicare Payment Updates from the RUC?

Mainstream primary care physicians are confused by the RVU methodologies, disenchanted with the competing specialties in the process, distrustful of the politics surrounding them and disdainful with the RVU conversion to dollars and payment. While policy, economic and physician experts are grappling over tenths of an RVU, the street level PCPs have become disengaged.

The key question for readers of the DMCB: While us do-gooders in the population-health biz have GREAT ideas on how to make life better for physicians and their patients, why should docs, given their experience with RVUs (and capitation and P4P) believe that we aren’t offering more disappointment?

+++++++++++++++++++++++++

Off topic, but DMCB is having an 'egads, what were you thinking!?' moment over the bad Gator behavior of young and future physicians. A study from the Journal of General Internal Medicine:

Abstract

Aim To measure the frequency and content of online social networking among medical students and residents.

Methods Using the online network Facebook, we evaluated online profiles of all medical students (n = 501) and residents (n = 312) at the University of Florida, Gainesville. Objective measures included the existence of a profile, whether it was made private, and any personally identifiable information. Subjective outcomes included photographic content, affiliated social groups, and personal information not generally disclosed in a doctor–patient encounter.

Results Social networking with Facebook is common among medical trainees, with 44.5% having an account. Medical students used it frequently (64.3%) and residents less frequently (12.8%, p < .0001). The majority of accounts (83.3%) listed at least 1 form of personally identifiable information, only a third (37.5%) were made private, and some accounts displayed potentially unprofessional material. There was a significant decline in utilization of Facebook as trainees approached medical or residency graduation (first year as referent, years 3 and 4, p < .05).

Discussion While social networking in medical trainees is common in the current culture of emerging professionals, a majority of users allow anyone to view their profile. With a significant proportion having subjectively inappropriate content, ACGME competencies in professionalism must include instruction on the intersection of personal and professional identities.

According to MSNBC:

'Erick W. Black, one of the researchers, said he found pictures of students grabbing their breasts and crotches, posing with a dead raccoon and multiple photos of residents and medical students drinking heavily.

Many students had joined Facebook groups that could be considered sexist, racist or downright nasty, with many using vulgar language. Some of the tamer groups included 'Physicians looking for trophy wives in training' and 'PIMP' (Party of Important Male Physicians).''

The DMCB asks if instruction in the use of common sense might also be in order. DMCB spouse opines 'they should not be allowed to graduate!'