Clinical Information Technologies and Inpatient Outcomes: When We Detect a Possible "VIOXX moment", How Promptly Should We Act?

I recently read the article "Clinical Information Technologies and Inpatient Outcomes" , Archives of Internal Medicine 169(2), Jan. 26, 2009 and found it fascinating. Full text is available as of this writing at this link .

The authors conducted a cross-sectional study of urban hospitals in Texas using a "Clinical Information Technology Assessment Tool" (CITAT), a questionnaire designed to measure a hospital’s level of automation based on physicians' reported interactions with actual information systems.

They then examined whether greater automation of hospital information was associated with reduced rates of inpatient mortality, complications, costs, and length of stay for 167,000 patients older than 50 years admitted to responding hospitals between Dec. 1, 2005, and May 30, 2006.

Here is one of the study's findings as summarized in its abstract:

Results We received a sufficient number of responses from 41 of 72 hospitals (58%). For all medical conditions studied, a 10-point increase in the automation of notes and records was associated with a 15% decrease in the adjusted odds of fatal hospitalizations (0.85; 95% confidence interval, 0.74-0.97). Higher scores in order entry were associated with 9% and 55% decreases in the adjusted odds of death for myocardial infarction and coronary artery bypass graft procedures, respectively.

Having designed highly customized, detailed information systems for outcomes improvement and mortality and morbidity reduction in invasive cardiology, I am fascinated by suggestions of significant mortality risk reductions in Myocardial Infarction (MI) and Coronary Artery Bypass Grafts (CABG) related to usage of (non specialized) Computerized Physician Order Entry (CPOE) technology.

The authors acknowledge that there are many possible confounding variables in this study, which is based on surveys of physician health IT usage and hospital reporting data, not on far more robust randomized controlled trials. While I agree with the authors that followup validation of this cross sectional study's findings are needed, I do have a concern.

I am troubled by the implication of such a cardiology mortality reduction based on CPOE use, if real.

If this finding is real, one implication is that increased MI and CABG mortality in organizations *not* using CPOE are due to preventable errors of omission and commission in ordering. Importantly, these errors do not necessarily require expensive computers to correct. They can be corrected through human means.

While this reduced cardiology mortality association sounds possibly spurious on the basis of this implication, in my mind this is an alarming finding, potentially meriting prompt and comprehensive investigation.

After a possible "VIOXX moment" is discovered, just how long do we as a society wait before conducting a more thorough investigation?

Finally, the following question also arises. Do observational studies of HIT, subject to confounders and false conclusions of causality regarding associations, possibly create more problems than they solve? For example, the "red flag" described above? Are such studies - as opposed to robust controlled clinical trials - akin to unnecessary medical testing that finds anomalies and "unidentified bright objects", resulting in more fritter that wastes time and money?

I do not know the answer to this question, but I do tend much more towards robust HIT evaluation studies. One reason is that significant money is about to be poured into HIT.

I feel it's best we actually know what we're doing when $20 billion has just been queued up to be handed out for HIT. Some of it will go to good people, but also a significant amount will go to pre-Flexner style electronic snake oil salespeople in vendor organizations and hospitals, who will squander the funds on preventable IT misadventure. Let the Joint Commission Sentinel Event Alert on HIT and the National Research Council report "Current Approaches to U.S. Health Care Information Technology are Insufficient" be my witness.

(I'm not confident critical thinking people such as myself who have not succumbed to irrational exuberance over HIT will see any of that $20 billion, because we actually know what we're doing and don't suffer health IT malpractice and mal-practitioners easily.)

-- SS

Post Title → Clinical Information Technologies and Inpatient Outcomes: When We Detect a Possible "VIOXX moment", How Promptly Should We Act?

BLOGCAN - " When a Measurement Becomes a Target, It is no Longer a Valid Measurment"

On the Retired Doc's Thoughts blog, Dr James Gaulte offers some insight into the problems with scorecards for physicians or hospitals, and resulting pay-for-performance (P4P) schemes. The main idea comes from an economist: " Once a measure is made a target for the purpose of conducting policy, it will loose the information content that would qualify it to play such a role." The idea is once a measure becomes a quality or P4P target, it will be gamed, and pursuit of its improvement may lead to unintended consequences that can harm other aspects of quality.

Post Title → BLOGCAN - " When a Measurement Becomes a Target, It is no Longer a Valid Measurment"

More About the Inexplicable Shutdown of a Quality Research Project

We have posted twice about the inexplicable decision by the US Office for Human Research Protection (OHRP) to shut down an observational study which meant to assess possible effects of a quality improvement initiative aimed at reducing hospital infections (here and here). Maggie Mahar, who also posted about the story in the Health Beat blog, did a little follow up investigation, which she initially reported in a comment on her initial post, and then, in somewhat more detail, on a post on the Health Care blog. It turns out that the history of the OHRP is somewhat questionable, and may be a surprise to many. I, like I am sure others, actually confused the OHRP with the Office of Protection from Research Risks (OPRR). But it turns out, according to Mahar,

As for the ORHP itself, I'm told its a 'strange creature' that was created in 2000 to replace the Office of PRotection from Reserarch Risks. Allegedly, the Office of Protection from Research Risks, which reported to the NIH, had been doing its job too zealously.

The OHRP would report directly to the assistant secretary of health--giving the administration more control over its activities.

Furthermore,

When ORHP began writing letters to Johns Hopkins and Michigan the head of OHRP was Bernard Schwetz. (He suddenly resigned in August, but this all happened on his watch.) Schwetz is a veterinarian. I'm not kidding. He's a DMV. He also has a Ph.D. and is a toxicologist.

When you look into his background, you find out that he seems to be a political appointee. At the very beginning of Bush's first term, Schwetz was made deputy acting commissioner of the FDA. That's right a vet was deputy acting commissioner of the FDA for a year. (I have nothing against vets, but this doesn't make a lot of sense.)

This was not a bright period in the FDA's history. During Schwetz's tenure, Dan Troy, who was the FDA's counsel, began running the FDA from behind the scenes. Troy had a been long-time enemy of the FDA-- representing Brown & Williamson in its fight against the FDA and, just a few months before he joined the agency, Troy was representing Pfizer in another battle with the FDA. As one magazine (U.S. News?) put it 'Mr. Outside Goes Inside' and proceeded to do his best to dismantle the FDA.(This is all documented in my book, Money-Driven Medicine. Congressmen protested and eventually Troy was forced to resign.)

The FDA Counsel was a former lawyer for the tobacco industry? It turns out that was true. He had also previously represented Pfizer. He was also accused of being far too cozy with the pharmaceutical industry while he was at the FDA (see this news article from the BMJ). Apparently Troy was also the first FDA Counsel who was a political appointee (see this news article from JAMA).

A veterinarian was running the Office of Human Research Protection? Curiouser and curiouser. I hope that Maggie Mahar and others will look further into this. Stay tuned.

ADDENDUM (4 January, 2008) - Ms Mahar updated her discussion of the background of the OHRP and OPRR here on the Health Beat blog.

ADDENDUM (18 January, 2008) - Ms Mahar has added several more updates, the most recent here. Also see this post from the Comarow on Quality blog. Comarow interviewed OHRP officials, but still was unable to figure out the reason they shut down the research project.

Post Title → More About the Inexplicable Shutdown of a Quality Research Project

An Idiotic Review Board? AKA The Office for Human Research Protections

Another view on this post "Why was this QI Project Shut Down":

It is possible to adhere to institutional "process" so blindly and so obstinately, ignoring common sense (which may not be all that common) as to impair medical progress.

It has been also said that "process" is no substitute for smart people, but tries to be, based upon beliefs in management theories (a.k.a. "management mysticism") and simplistic, mechanistic views about how the world really works. Unfortunately, any theory, rule, or process taken too far or adhered to too rigidly can have major downsides.

The case below is such an example of this, where process trumps common sense, cleverness trumps wisdom:

A Lifesaving Checklist
By ATUL GAWANDE
New York Times, Dec. 30, 2007

In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

The government’s decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.

For the love of god ... perhaps only a bureaucrat is capable of such idiotic thinking? Most if not all of the items on the checklist could be read in any introductory text on medicine or The Washington Manual. They were reminders of the obvious, not experimental protocols.

The overly litigious and predatory nature of U.S. healthcare also affected the thinking of the Office for Human Research Protections, I'm sure, and this idiocy is perhaps another example of the pernicious effects of the litigiousness. Predatory lawyers and bumbling bureacrats are not among my list of primary actors for creation of sound medical policy.

... Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the [checklist] endeavor itself is treated as the danger.

If the government’s ruling were applied more widely, whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease; the military’s program to track the care of wounded soldiers; the Five Million Lives campaign, by the nonprofit Institute for Healthcare Improvement, to reduce avoidable complications in 3,700 hospitals nationwide.

... Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they’re in danger of putting ethics bureaucracy in the way of actual ethical medical care. The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to.

Atul Gawande, a surgeon at Brigham and Women’s Hospital in Boston and a New Yorker staff writer, is the author of “Better."

The "process fanatic" will be the death of good medicine, including those who believe that all of medicine can be deterministically modeled and cybernetic miracles worked with EHR's.

Speaking of religion, and considering the above report came out just after Christmas, the following humorous but meaningful piece comes to mind. Ironically, both the NYT story and the piece below were sent to me by different parties independently at around the same time:

IRB Global Observational Study of Behavior in Children review

Dr. K Kringle
Adjunct Professor of Child Psychology
Far Northern University

Dear Dr. Kringle (Ph.D, M.D., D.O.? Please verify your credentials):

At the regularly scheduled December 24 meeting, the IRB reviewed your protocol, "A Global Observational Study of Behavior in Children" While we believe it has many good features, it could not be approved as submitted. If you choose to revise your study, please address the following IRB concerns:

1. You propose to study "children of all ages." Please provide an exact lower and upper age limit, as well as the precise number of subjects. Provide a statistically valid power calculation to justify this large of a study.

2. Your only inclusion criterion is "belief in Santa Claus." Please provide a copy of the screening questionnaire that determines such a belief. Provide a Waiver of Authorization under MPAA in order to record these beliefs prior to enrollment in your study. The Board recommends that you obtain a Certificate of Confidentiality as beliefs are sensitive and personal information.

3. You propose to "know when they are sleeping and know when they are awake." How will this be done? Will children undergo video monitoring in their beds? Will they have sleep EEGs? You list 100 elves as research assistants. Are any of them sleep physiologists? Please provide credentials of elves.

4. Your primary outcome measure is to "know when they've been bad or good." What standard is being used to determine "goodness"? Do children have to be good all year or just most of the time? Please specify required duration and provide the instrumentation, with appropriate consent forms, that will be used for operationally defining "goodness."

5. You propose to conduct your research by entering the subjects' homes through the chimney. Have you considered the liability potential, i.e., damage to the roof, carpeting, etc., that this will cause? Moreover, children are likely to be startled by your appearance late at night. Please revise your protocol to conduct your home visits between 9 am and 5 pm Monday through Friday with at least one parent being present and all risks and benefits carefully described.

6. You state that compensation for participation will be "sugarplums, candy, and toys" for the good little girls and boys. This may not be appropriate for the children with obesity, dental cavities, and hyperactivity. Also, your proposal to leave a lump of coal in the stockings of the bad children will be unfairly stigmatizing to them individually and as a group. In general, the Board suggests a small token of appreciation for all participants. Perhaps a $5 Toys-R-Us gift card would be more appropriate in order to avoid potential coercion.

7. The database of good and bad children will be kept "on a scroll at the North Pole." Please describe the location of the scroll and the security provisions you have in place to protect the data Is the scroll kept in a locked cabinet in a locked room? Who has access to the scroll? Are there backup copies of the scroll and how often are they compared to the original?

8. You mention the participation of "eight tiny reindeer" in your protocol. Please provide the Board with documentation of Institutional Animal Care and Use Committee approval.

9. Please provide the Human Subjects Protection training dates for Mrs. Claus and the elves.

10. As this study involves prospective data collection and is more than minimal risk without prospect of direct benefit to the subjects, informed consent signed by both parents will be required. Please have the consent form translated into every language spoken by children and ensure that assent forms are signed by all.

Please submit 25 copies of your revised protocol to the IRB. The IRB will be on Holiday Season schedule for the next two weeks. If approved, you will be able to conduct your study sometime in the spring, if all items are appropriately addressed.

Sincerely,
E. Scrooge, MD

Chair, Institutional Review Board

Copyright 2006, David R. Karp

-- SS

Post Title → An Idiotic Review Board? AKA The Office for Human Research Protections

Why Was This Quality Improvement Research Project Shut Down?

An op-ed in the New York Times by Dr Atul Gawande drew attention to an inexplicable government decision to shut down an apparently worthwhile research project.

IN Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

There seemed to be no question that the the quality improvement (QI) project involved an intervention on physicians, not patients. The project involved use of a simple checklist by intensive care unit (ICU) physicians designed to reduce hospital-acquired infections. The items on the check-list, described in a New England Journal of Medicine article [Pronovost P, Needham D, Berenholtz S et al. An intervention to decrease catheter-related bloodstream infections in the ICU. New Engl J Med 2006; 355:2725-2732. See link here.] consisted of "hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters."

The prospective cohort study apparently collected data from the charts of patients hospitalized after use of the check-list was begun to determine their clinical outcomes.

The main objection by the OHRP seemed to be that the project did not get permission from patients to use information from their clinical records. Research involving collecting data from patients' clinical records usually is considered to be extremely low risk to patients if the information collected is not sensitive, and the researchers protect the confidentiality of the data.

The decision to shut down this observational research project appeared to be extreme and based on, to be charitable, exceedingly narrow and nit-picking ground. The data collected did not appear to be sensitive; there was no question about protection of its confidentiality; the QI intervention could have been carried out without associated research and without patient informed consent (since the intervention affected physicians directly, not patients); and the study was apparently approved by local institutional review boards (IRBs). (See two letters by Kristina C. Borror, Ph.D., Director of the Division of Compliance Oversight at OHRP, to Johns Hopkins University officials, here and here.)

Gawande called the government's decision "bizarre and dangerous." On the Health Beat blog, Maggie Maher speculated, "someone was worried that the checklist program would draw too much attention to just how prone to error our healthcare system is." On the Health Care Organizational Ethics blog, Dr Jame Sabin cited the Hastings Center report on the ethics of QI research, and wrote, "it is hard to avoid suspicion about the motives of the OHRP for scuttling the project. But whatever the motivation behind OHRP’s actions, it is important for the agency to reverse course promptly."

While doctors are endlessly criticized for medical errors and poor quality care, there has been little financial support for quality improvement research available from government, foundations, or commercial sources. Thus it is galling to see an apparently worthwhile and very low risk quality improvement study shut down, especially when much more risky interventional studies are allowed to continue.

For example, while this study was shut down, the US Food and Drug Administration (FDA) let a poorly designed controlled trial of gene therapy administered into individually inflamed joints of patients with inflammatory arthritis, a trial which already saw the unexpected and unexplained death of one subject from overwhelming infection, restart (see post here). Maybe it is time for conspiracy theories...

ADDENDUM (2 January, 2008) - also see comments on the Effect Measure blog, and by MedInformaticsMD on Health Care Renewal.

Post Title → Why Was This Quality Improvement Research Project Shut Down?

Health Wonk Review, Health Care Renewal Style

Welcome to Health Care Renewal. Health Care Renewal was the product of brain-storming by some physicians and health care researchers who wondered why as health care costs inexorably rose, access decreased, and quality remained stagnant. With health care reform again looming, no one seemed to be able to explain this, much less have any solutions.

We found we all knew stories that suggested systemic problems with health care that provided some explanations, but seemed rarely to be discussed in polite conversation.

Basically, the problems arose from concentration and abuse of power. As health care organizations grew ever larger and more powerful, their governance became more unrepresentative of their constituencies, secretive and opaque, unaccountable, and unethical and amoral.

Resulting practices were marked by conflicts of interest, deception and dishonesty, intimidation and coercion, and sometimes outright corruption, bribery, fraud, and other criminal behavior.

Although many physicians knew of local examples of these issues, and some cases had been described in the local news media, they produced few echos. In particular, discussion of them in academia and the medical and health care and policy literature seemed taboo. We called this the "anechoic effect."

The mission of Health Care Renewal is to discuss these problems, end the anechoic effect, and help find solutions. We present this edition of Health Wonk Review in this spirit, and with an organizational framework derived from the discussion above. We feature submissions by many HWR regulars, but also note posts in many of the newer blogs that too are concerned with the dark side of health care.

Health Care Reform and Policy in General

On the Health Care Policy and Marketplace Review, Bob Laszewski noted the lack of differences among the health care reform proposals of the current US candidates for the presidency, suggesting "that you not cast your caucus or primary vote for a candidate based upon their health care reform plan because from 'thirty thousand feet' there isn't all that much difference" among them.

Governance

On Health Care Renewal, we have posted frequently on payments made by medical device companies to physicians and health care organizations. Of particular interest is the money that companies who make to artificial joints have been giving to the major national orthopedic associations and to some of their leaders, raising questions of whose interests these organizations really care about. (See posts here and here.) A recurring theme on Health Care Renewal is the pervasiveness of conflicts of interest that raise questions about whom health care professionals really work for, and what interests health care organizations really serve.

Practices

On the Canadian Medicine blog, Sam Solomon addressed the controversy about Canadian physicians' new practice of outsourcing their billing for uninsured services, and its implications for patient privacy.

On the Health Beat Blog, Maggie Mahar pointed out how Wall Street seems not to care about the ethics of health care corporations, "the Street doesn’t care about the ethics of what the company is doing; investors care about whether or not the company is making a profit." But, "meanwhile, both companies and individuals in our for-profit health care industry continue to engage in criminal activities."

Zagreus Ammon on the Physician Executive blog presented his "hyper realist" take on the Avandia controversy. Forgive me if I fear this "hyper realism" shades into the cynicism. For example, he asserted, "pharmaceutical companies insist on controlling and potentially suppressing clinical information about the drugs they wish to sell. This is natural and indignation is laughable." It may be natural, but it can harm patients by depriving them and their physicians of the accurate evidence they need to make decisions. It is also an ethical affront to the patients who participate in clinical research thinking they were taking part to advance science and patient care. For the latest Health Care Renewal discussion of the Avandia case, go here.

On the other hand, Dr Aubrey Blumsohn on the Scientific Misconduct Blog analyzed the shenanigans now going on in the analysis and reporting of the ENHANCE trial of ezetimibe (Zetia, and an active ingredient in Vytorin). Further commentary on this issue can be found in the Hooked: Ethics, Medicine and Pharma blog by Dr Howard Brody, and in the Medical Evidence Blog by Dr Scott Aberegg. This is just the latest of many examples of how health care corporations who "sponsor" clinical research may try to make sure the results favor their products.

A graphic example of the sorts of people some pharmaceutical companies hire to perform clinical research appears on the Clinical Psychology and Psychiatry blog. Warning, it includes how a pharma-sponsored physician researcher managed to personally give two of his patients genital herpes simplex infections.

Dr Daniel Carlat on the Carlat Psychiatry Blog reprised (here and here) his New York Times Magazine article on his brief career as a part-time paid pharmaceutical company lecturer. The article provided a vivid narrative showing the ethical challenges of one pharmaceutical company's stealth marketing practices. See also comments on Dr Carlat's article on the Health Care Organizational Ethics blog.

Cost

Dr Adam J Fein at Drug Channels examined "how the upcoming disappearance of Average Wholesale Prices (AWP) will affect Pharmacy Benefit Managers (PBMs). He argues that PBMs should not be materially impacted by a shift in the drug pricing benchmark from AWP, especially as private payors start using the new CMS benchmark called Average Manufacturer Price."

Jason Shafrin on the Health Care Economist blog analyzed the reasonableness of expecting physicians to compete on the price of procedures. He noted that this may work for very routine, low risk procedures, but may not make sense in more complex situations in which outcomes are unpredictable.

Rob Cunningham on the Health Affairs Blog reported that "Congressional Budget Office Director Peter Orszag warns that policymakers have 'misdiagnosed' the biggest problem facing both Medicare and the health economy in general by overstating the projected impact of population aging and the impending retirement of the baby boom."

On GoozNews, Merrill Goozner provided an example of how expensive procedures are hyped, while the shortcomings of the evidence supporting the procedures, and the conflicts of interest of the hypers are buried.

The next three posts related to the seeming irrationality of how government agencies pay for procedures versus "cognitive" services.

David Harlow at HealthBlawg noted that the "CMS efficiency and effectiveness machinery turns its attention (again) to diagnostic imaging, field-testing four measures which will eventually be used in denials," and "asked what about bringing the same brains and brawn to bear on the CMS approach to physician compensation generally, rather than on one piece of ancillary income?"

Henry Stern at the InsureBlog wrote "One criticism of nationalized health care is that care may be rationed. But what about paying for procedures with no health benefits at all? InsureBlog's Henry Stern has the story of how one system pays for elective hymen-replacement surgery."

Jon Coppelman at the Workers' Comp Insider blog looked "at the pending Full Parity for Mental Illnesses bill that is before Congress, and explains why it is unlikely we will see parity for occupational injuries and illnesses any time soon."

Some insights on why US government reimbursement is so seemingly irrational and inexplicable come from this post on DB's Medical Rants. The anonymous DB reminds us that all US Medicare physician reimbursement is heavily influenced by a secretive AMA committee called the RBRVS Update Committee (RUC), whose membership is not public, but seems to be dominated by proceduralist physicians. Similarly, James Gaulte on the Retired Doc's Thoughts blog explained how the RUC undermined the rationale for setting up the RBRVS (Resource Based Relative Value System) in the first place, to more equitably reimburse primary care and "cognitive" services.

On the Covert Rationing Blog, DrRich wondered if a lawsuit trying to void Medicare's irrational physician reimbursement could succeed.

On the other hand, David Williams at the Health Business Blog addressed how the US government funds, or does not fund, small health care businesses. He interviewed "BIO's Alan Eisenberg re: SBIR grant eligibility for majority-VC [venture capital] backed companies, [letting] ... Eisenberg tell BIO's side of the story."

One post addressed the weirdness that seems to infect normal people when they try to write about health care costs. On the Health Beat Blog, Maggie Mahar critiqued the "muddle" that a New York Times editorial produced when it addressed health care costs, weaving "truth and error together in such a way that it would take a knitting needle to separate the two." and finally collapsing "into a confusion of contradictory clichés." Unfortunately, the same could be said about a lot that is written about health care policy, particularly the cost side, (but not by our HWR bloggers).

Quality

Loraine Lawson on the Good Ideas That Work blog asked, "Want to know how to curtail the spread of AIDS? Ask Brazil, where, in the early 1990s, health authorities feared the epidemic could 'grow out of control' (whatever that means). According to Reuters, new AIDS cases in Brazil fell to 17.5 per 100,000 people, which is down considerably from the 22.2 per 100,000 recorded in 2002."

Access

Ian Walsh at the Agonist blog observed that problems with health care access may arise because those who make health care policy, for example, the US Congress, have a special deal on health coverage that mean they do not have to struggle with the problems ordinary citizens face, "the fact that they live in a privileged bubble and that the reason they don't even try to fix the problems of ordinary Americans is because they don't share them."

On the Managed Care Matters blog, Joe Paduda examined how US universal coverage plans could deal with illegal immigrants, but noted that meanwhile, Mexico may come up with a universal coverage system before the US does.

Louise Norris on the Colorado Health Insurance Insider blog discussed obstacles to mandatory health insurance, noting the need to trim costs, starting with amazingly well paid hospital and managed care CEOs.

Anthony Wright on the Health Access WeBlog reviewed "two articles on the SCHIP fight, California’s pending decision as a result to disenroll kids from coverage, and why the problem is both worse than we think (violating 10 years of outreach and trust) and better (there’s a certain political resolution)."

Thanks again for visiting Health Care Renewal and perusing the Health Wonk Review. The Health Wonk Review web-site is here. Also, see our side-bar for a nearly complete listing of previous Health Wonk Review editions.

Post Title → Health Wonk Review, Health Care Renewal Style

A Web of Deception Ensnares US Nursing Homes

The New York Times just published a report of some important investigative reporting about changes in how US nursing homes are currently managed, or mismanaged, leading to bad effects on patients' outcomes and safety. As an example, the report recounted the case of an elderly women who died in the Habana Health Center in Tampa, FL. The article made a series of key points,

• The homes were acquired by private equity companies not usually associated with health care.
• The companies drastically cut the costs of their acquisitions.
• These cost cuts decreased care, apparently leading to poor outcomes.
• The private equity companies set up complex corporate structures for their acquisitions, hiding their ownership, and thwarting lawsuits and regulation.

I have summarized supporting quotes for each point below.

Acquisition by Private Equity Companies

The changes seem to stem from the acquisition of many nursing homes and nursing home chains by "large Wall Street investment companies .... Those investors include prominent private equity firms like Warburg Pincus and the Carlyle Group, better known for buying companies like Dunkin’ Donuts. As such investors have acquired nursing homes, they have often reduced costs, increased profits and quickly resold facilities for significant gains."

The acquisitions involved were substantial. "But in recent years, large private investment groups have agreed to buy 6 of the nation’s 10 largest nursing home chains, containing over 141,000 beds, or 9 percent of the nation’s total. Private investment groups own at least another 60,000 beds at smaller chains and are expected to acquire many more companies as firms come under shareholder pressure to sell."

Drastic Cost Cutting

The major manifestations of mismanagement seem to be drastic cost cutting.

'The first thing owners do is lay off nurses and other staff that are essential to keeping patients safe,' said Charlene Harrington, a professor at the University of California in San Francisco who studies nursing homes. In her opinion, she added, 'chains have made a lot of money by cutting nurses, but it’s at the cost of human lives.'

The Times’s analysis of records collected by the Centers for Medicare and Medicaid Services reveals that at 60 percent of homes bought by large private equity groups from 2000 to 2006, managers have cut the number of clinical registered nurses, sometimes far below levels required by law. (At 19 percent of those homes, staffing has remained relatively constant, though often below national averages. At 21 percent, staffing rose significantly, though even those homes were typically below national averages.) During that period, staffing at many of the nation’s other homes has fallen much less or grown.

Nurses are often residents’ primary medical providers. In 2002, the Department of Health and Human Services said most nursing home residents needed at least 1.3 hours of care a day from a registered or licensed practical nurse. The average home was close to meeting that standard last year, according to data.

But homes owned by large investment companies typically provided only one hour of care a day, according to The Times’s analysis of records collected by the Centers for Medicare and Medicaid Services.

For the most highly trained nurses, staffing was particularly low: Homes owned by large private investment firms provided one clinical registered nurse for every 20 residents, 35 percent below the national average, the analysis showed.

Poor Patient Outcomes

In turn, such cost cutting was associated with poor outcomes.

The typical nursing home acquired by a large investment company before 2006 scored worse than national rates in 12 of 14 indicators that regulators use to track ailments of long-term residents. Those ailments include bedsores and easily preventable infections, as well as the need to be restrained. Before they were acquired by private investors, many of those homes scored at or above national averages in similar measurements.

In addition,

Regulators with state and federal health care agencies have cited those staffing deficiencies alongside some cases where residents died from accidental suffocations, injuries or other medical emergencies.

Federal and state regulators also said in interviews that such cuts help explain why serious quality-of-care deficiencies — like moldy food and the restraining of residents for long periods or the administration of wrong medications — rose at every large nursing home chain after it was acquired by a private investment group from 2000 to 2006, even as citations declined at many other homes and chains.

The typical number of serious health deficiencies cited by regulators last year was almost 19 percent higher at homes owned by large investment companies than the national average, according to analysis of Centers for Medicare and Medicaid Services records.

In the case of Habana Health Center,

Habana’s managers increased occupancy, and cut expenses by laying off about 10 of 30 clinical administrators and nurses, Medicare filings reveal. (After regulators complained, some positions were refilled and other spending increased.) Soon, Medicare regulators cited Habana for malfunctioning fire doors and moldy air vents.

'Those owners wouldn’t let us hire people,' said Annie Thornton, who became interim director of nursing around the time Habana was acquired, and who left about a year later. 'We told the higher-ups we needed more staffing, but they said we should make do.'

Regulators typically visit nursing homes about once a year. But in the 12 months after Formation’s acquisition of Habana, they visited an average of once a month, often in response to residents’ complaints. The home was cited for failing to follow doctors’ orders, cutting staff below legal minimums, blocking emergency exits, storing food in unhygienic areas and other health violations.

Soon after, nursing home inspectors wrote in Centers for Medicare and Medicaid Services documents that Habana was at fault when a resident suffocated because his tracheotomy tube became clogged. Although he had complained of shortness of breath, there were no records showing that staff had checked on him for almost two days.

Five months later, Mrs. Hewitt discovered that her mother had a large bedsore on her back that was oozing pus. Mrs. Garcia was rushed to the hospital. A physician later said the wound should have been detected much earlier, according to medical records submitted as part of a lawsuit Mrs. Hewitt filed in a Florida Circuit Court.

Three weeks later, Mrs. Garcia died.

Complex, Opaque Corporate Structures

Particularly fascinating and disturbing was the evidence that the nursing homes' managers evaded regulation, and legal responsibility for what they were doing by creating immensely complicated and opaque corporate structures.

Private investment companies have made it very difficult for plaintiffs to succeed in court and for regulators to levy chainwide fines by creating complex corporate structures that obscure who controls their nursing homes.

By contrast, publicly owned nursing home chains are essentially required to disclose who controls their facilities in securities filings and other regulatory documents.

The Byzantine structures established at homes owned by private investment firms also make it harder for regulators to know if one company is responsible for multiple centers. And the structures help managers bypass rules that require them to report when they, in effect, pay themselves from programs like Medicare and Medicaid.

For example,

Formation bought Habana, 48 other nursing homes and four assisted living centers from Beverly Enterprises, one of the nation’s largest chains, for $165 million.

Formation immediately leased many of the homes, including Habana, to an affiliate of Warburg Pincus. That firm spread management of the homes among dozens of other corporations, according to documents filed with Florida agencies and depositions from lawsuits.

Each home was operated by a separate company. Other companies helped choose staff, keep the books and negotiate for equipment and supplies. Some companies had no employees or offices, which let executives file regulatory documents without revealing their other corporate affiliations.

Current staff members at Habana declined to comment. Formation Properties I said it owned only Habana’s real estate and leased it to an independent company, and thus bore no responsibility for resident care.

That independent company — Florida Health Care Properties, which eventually became Epsilon Health Care Properties and subleased the home’s operation to Tampa Health Care Associates — is affiliated with Warburg Pincus, one of the world’s largest private equity firms. Warburg Pincus, Florida Health Care, Epsilon and Tampa Health Care all declined to comment.

The example of Habana Health Center showed how the complex and opaque corporate structures thwarted regulators.

Those [government] citations never mentioned Formation, Warburg Pincus or its affiliates. Warburg Pincus and its affiliates declined to discuss the citations. Formation said it was merely a landlord.

'Formation Properties owns real estate and leases it to an unaffiliated third party that obtains a license to operate it as a health care facility,' Formation said. 'No citation would mention Formation Properties since it has no involvement or control over the operations at the facility or any entity that is involved in such operations.'

Florida’s Agency for Health Care Administration has named Habana and 34 other homes owned by Formation and operated by affiliates of Warburg Pincus as among the state’s worst in categories like 'nutrition and hydration,' 'restraints and abuse' and 'quality of care.' Those homes have been individually cited for violations of safety codes, but there have been no chainwide investigations or fines, because regulators were unaware that all the facilities were owned and operated by a common group, said Molly McKinstry, bureau chief for long-term-care services at Florida’s Agency for Health Care Administration.

And even when regulators do issue fines to investor-owned homes, they have found penalties difficult to collect.

'These companies leave the nursing home licensee with no assets, and so there is nothing to take,' said Scott Johnson, special assistant attorney general of Mississippi.

Complex corporate structures also enable nursing home management to evade scrutiny of what they charge.

Government programs require nursing homes to reveal when they pay affiliates so that such disbursements can be scrutinized to make sure they are not artificially inflated.

'The government tries to make sure homes are paying a fair market value for things like rent and consulting and supplies,' said John Villegas-Grubbs, a Medicaid expert who has developed payment systems for several states. 'But when home owners pay themselves without revealing it, they can pad their bills. It’s not feasible to expect regulators to catch that unless they have transparency on ownership structures.'

In the case of Habana Health Center,

For example, Habana, operated by a Warburg Pincus affiliate, paid other Warburg Pincus affiliates an estimated $558,000 for management advice and other services last year, according to reports the home filed.

However, complex corporate structures make such scrutiny difficult. Regulators did not know that so many of Habana’s payments went to companies affiliated with Warburg Pincus.

Summary

We see some very familiar themes in this sorry tale.

Health care is increasingly dominated by large organizations. In this case, some of these organizations are not usually identified with health care, and the identity of other organizations is secret.

The leadership of many health care organizations will put their financial self-interest ahead of patients' interests.

The leadership of many health care organizations will hide what they are doing, evade responsibility, and thwart accountability by deliberate complexity and outright deception.

Until the leadership of health care organizations becomes more transparent and accountable, things are likely to continue to go downhill.

Once again, "sunlight is the best disinfectant."

Post Title → A Web of Deception Ensnares US Nursing Homes

Which Frogs A-Leaping?

Reported so far mainly in medical news outlets, e.g., in WebMD health news, was a survey from the Leapfrog Group naming the US best hospitals. There has also been some local coverage in areas in which some of the named hospitals are based, e.g., here in the Star-Telegram.

The Leapfrog Group proclaims itself to be "a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded." It is usually described as a group of large employers out to improve health care.

Is that description accurate? Who are its members.? The most recent list is here.

On it are some well known large companies, such as Boeing and IBM. But what is most striking about its membership is the prevalence of health care corporations. A full 14 of 49 members (28.6%) are health care corporations. These include pharmaceutical companies, e.g.,

• Boehringer Ingelheim,
• Eli Lilly and
• Sanofi-Aventis.

These also include health care insurers and managed care organizations, e.g.,

• Aetna Inc,
• Blue Shield of California,
• HCA,
• UnitedHealth, and
• Wellpoint.

These include hospitals and hospital networks, e.g.,

• Greenville Hospital System, and
• Heartland Surgical Specialty Hospital.

And these include other health care companies, e.g.

• Milliman (purveyors of care guidelines), and
• Thomson Healthcare (providers of health care information resources).

The members also include companies who, while not being purely in health care, have significant health care businesses, such as General Electric.

One would expect that companies who make money by providing health care goods and services may have different ideas about health care costs and quality than companies who do not do any health care related business.

So it seems that it is the truth that the Leapfrog Group is an organization of employers, it is not the whole relevant truth. In fact, it appears that the Group includes significant representation of companies who have vested interests in health care being done in certain ways. Thus, its ideas about how to improve quality and lower costs may have been influenced by the vested interests of its members, which may not represent just the interests of employers who provide health insurance to their employees. At least, the organization should make clear that it includes "employers" who also sell drugs, sell health insurance, manage care, and market health care information.

This seems like another example, in a somewhat different dimension, of conflicts of interest in health care, and of the failure of such conflicts to be clearly disclosed. This also seems like another demonstration that things are rarely what they seem in the complex and not always honest world of health care, particularly in the US.

In my humble opinion, full disclosure of all relevant conflicts in all dimensions, and consideration of whether certain kinds of conflicts should be not merely disclosed, but reduced or eliminated, might go a long way to improving our problems with health care costs, quality, and access.

"Sunlight is the best disinfectant."

Note, see our previous post here about a previous version of Leapfrog Group membership.

ADDENDUM (19 September, 2007) - On the Running a Hospital Blog, Paul Levy posted a bit more positively about Leapfrog, although he finished somewhat ambiguously by wondering whether the group has "lost importance" by hopping "over their own approach."

The WSJ Health Blog provided more detail about the LeapFrog hospital quality report here.

Post Title → Which Frogs A-Leaping?

Why Did VA Officials Get Bonuses for Questionable Performance?

The US Department of Veterans Affairs (VA) health care system, a national health care system that provides care to many veterans of the armed forces, has been held up lately as a model health care system. For example, after one study showed that diabetes care based on several quantitative measures was better in the VA system than in commercial managed care(1), the VA has been held up as an exemplar of quality improvement.(2)

But lately a bit of tarnish has appeared on its luster. And it appears that an organization that has put a lot of effort into improving performance in clinical care may conceive of performance very differently for top leaders.

Two weeks ago the Associated Press reported (here via the Boston Herald) that VA officials involved in various management blunders had nonetheless received performance bonuses.

Months after a politically embarrassing $1 billion shortfall that put veterans’ health care in peril, Veterans Affairs officials involved in the foul-up got hefty bonuses ranging up to $33,000.

The list of bonuses to senior career officials at the Veterans Affairs Department in 2006, obtained by The Associated Press, documents a generous package of more than $3.8 million in payments by a financially strapped agency straining to help care for thousands of injured veterans returning home from Iraq and Afghanistan.

Among those receiving payments were a deputy assistant secretary and several regional directors who crafted the VA’s flawed budget for 2005 based on misleading accounting. They received performance payments up to $33,000 each, a figure equal to about 20 percent of their annual salaries.

Also receiving a top bonus was the deputy undersecretary for benefits, who helps manage a disability claims system that has a backlog of cases and delays averaging 177 days in getting benefits to injured veterans.

The bonuses were awarded even after government investigators had determined the VA repeatedly miscalculated _ if not deliberately misled taxpayers _ with questionable methods used to justify Bush administration cuts to health care amid a burgeoning Iraq war.

Annual bonuses to senior VA officials now average more than $16,000 _ the most lucrative in government.

But yesterday, the Associated Press followed that up (here via San Diego Union-Tribune) with allegations that many of the VA officials who got bonuses themselves sat on the boards which made decisions about bonuses, which would seemingly lead to major conflicts of interest.

Nearly two dozen officials who received hefty performance bonuses last year at the Veterans Affairs Department also sat on the boards charged with recommending the payments.

Documents obtained by The Associated Press raise questions of conflicts of interest or appearances of conflicts in connection with the bonuses, some of which went to senior officials involved in crafting a budget that came up $1.3 billion short and jeopardized veterans' health care.

The documents show that 21 of 32 officials who were members of VA performance review boards received more than half a million dollars in payments themselves.

Among them: nearly a dozen senior officials who devised the flawed 2005 budget. Also rewarded was the deputy undersecretary for benefits, who manages a system with severe backlogs of veterans waiting for disability benefits.

Deputy undersecretaries who sit on the review boards, which are appointed by VA Secretary Jim Nicholson, also had input on bonus recommendations involving themselves, fellow members and spouses that made questionable performance claims and neglected agency problems.

The VA, which has defended the bonuses as necessary to retain hardworking senior employees, says board members do not participate in bonus decisions that involve themselves or fellow board members. In those cases, recommendations are made by agency heads in consultation with deputy undersecretaries, who usually serve as supervisors to their fellow board members, the agency says.

But government watchdogs were harshly critical, saying the process does little to instill public confidence in the fairness of awards.

In one case, Michael Walcoff, associate deputy undersecretary for field operations who sits on two of the review boards, and his wife, Kimberly, a VA director, received a package of bonuses totaling $42,000.

'This is a scandal in the making,' said Paul C. Light, professor of public service at New York University who specializes in government reform. He said the VA bonuses pointed to possible 'featherbedding' and other favoritism.

Under a federal law passed in 1978 to increase government accountability by tying bonuses more closely to performance, agencies are required to appoint performance review boards yearly to guarantee bonus awards are “fair and credible.”

According to guidance by the U.S. Office of Personnel Management, performance boards must ensure that bonuses are given based not only on individual accomplishments cited by supervisors, but also the department's overall success.

However, 2006 bonus proposals obtained by the AP show that senior officials who received top payments of $33,000 were sometimes credited for achievements that were questionable, if not inaccurate.

The matter has just been referred to an oversight agency, the US Office of Personnel Management, again per the AP via the Boston Herald.

This appears to be another example of how leaders of large health care organizations, whether governmental, commercial, or not-for-profit, are often treated differently from you and me. Not only may the leaders be rewarded for "performance" that often amounts to poor performance, but they may get to decide on their own rewards. And this can happen even in organizations that put a lot of effort into performance improvement on the ground.

Is it any wonder that health care lead by such winds up expensive, inaccessible, and not of the best quality, and why health care professionals are often demoralized?

References
1. Kerr EA, Gerzoff RB, Krein SL et al. Diabetes care quality in the Veterans Affairs health care system and commercial managed care: The TRIAD Study. Ann Intern Med 2004; 141: 272-281. (link here).
2. Kupersmith J, Francis J, Kerr EA et al. Advancing evidence-based care for diabetes: lessons from the Veterans Health Administration. Health Affairs 2007; 26: w156-w168. (link here)

Post Title → Why Did VA Officials Get Bonuses for Questionable Performance?

BLOGSCAN - Does Doing Surveys and Having Patient Registries Make a Doctor More "Patient-Centered?"

On the Retired Doc's Thoughts blog is a post criticizing bureaucratically derived measures of quality of care. It seems that to some, for doctors to provide "patient-centered care" requires them to use electronic medical records (EMRs), set up patient registries, and survey their own patients about quality of care. Although EMR advocates hype them as a panacea, readers of MedInformaticsMD's comments on Health Care Renewal will realize they have not yet lived up to that promise. As a (reformed?) health services researcher, I certainly value patient registries and survey instruments. But given how hard it is to design, execute, and interpret results from these tools, I wonder how merely having them available makes a doctor's care more "patient-centered?" Read Retired Doc's even crustier comments.

Post Title → BLOGSCAN - Does Doing Surveys and Having Patient Registries Make a Doctor More "Patient-Centered?"

Quick In-Store Health Care Clinics: "You're Sick. We're Quick!" but Will You Really Get Better?

There has been a lot in the media lately about quick in-store health care clinics, an issue which we blogged about previously here and here. In Illinois, as reported by the Chicago Tribune, the state medical society is pushing for more regulation, which is predictably not making clinic operators happy.

The Illinois State Medical Society, which represents more than 13,000 doctors, is pushing a proposed law to more closely monitor hundreds of in-store clinics being opened by retail giants Wal-Mart Stores Inc., Walgreen Co. and CVS/Caremark Corp.

The doctors claim the clinics, staffed by advanced-degree nurses and physicians' assistants, are largely unregulated and therefore put patients' health at risk.

The potential loss of business for doctors is great because most health insurance companies are beginning to cover retail clinic procedures.

Doctors say they are concerned about the quality of care if the clinics uphold their promise to treat patients in less than 15 minutes. The doctors said that is not enough time for consultation, and that follow-up may not be adequate.

Facing off against the doctors' powerful lobbying organization are the powerful pharmacy and retail industry lobbyists, who are trying to block the proposed legislation. Retailers say the clinics are staffed by licensed health professionals who track their patients' health in medical records and make referrals.

'Increased regulation has the potential to restrict access to these health-care services and create more costs to patients,' Walgreens spokesman Michael Polzin said. 'That would work against the growing concern over affordable, quality health care that our Health Corner Clinics are directly addressing.'

There is a paean to quick in-store clinics in a today's Wall Street Journal by free market health care booster Grace-Marie Turner.

It's Friday evening and you suspect that your child might have strep throat or a worsening ear infection. Do you bundle him up and wait half the night in an emergency room? Or do you suffer through the weekend and hope that you can get an appointment with your pediatrician on Monday -- taking time off your job to drive across town for another wait in the doctor's office?

Every parent has faced this dilemma. But now there are new options, courtesy of the competitive marketplace. You might instead be able to take a quick trip on Friday night to a RediClinic in the nearby Wal-Mart or a MinuteClinic at CVS, where you will be seen by a nurse practitioner within 15 minutes, most likely getting a prescription that you can have filled right there. Cost of the visit? Generally between $40 and $60.

These new retail health clinics are opening in big box stores and local pharmacies around the country to treat common maladies at prices lower than a typical doctor's visit and much lower than the emergency room. No appointment necessary. Open daytime, evenings and weekends. Most take insurance.

Much like the response to Hurricane Katrina, private companies are far ahead of the government in answering Americans' needs, this time for more accessible and more affordable health care. Political leaders across the country seeking to expand government's role in health care should take note.

This industry is in its infancy and will hardly register in our nation's $2 trillion-plus health care bill. But just as Nucor overturned the steelmaking industry with a faster-better-cheaper way of making low-end rebar, these limited service clinics could be the disruptive innovator in our health-care system. Package pricing for more complex treatments, like knee replacement surgery, may not be far behind.

Government can get in the way, of course, with protectionist policies that throw up more regulatory barriers to entry. But retail clinics could be just the beginning of consumer-friendly innovations....

What bothers me about all this? It seems to me that in-store clinics (of this type) could embody what goes wrong when the business managers and bureaucrats who are now in charge of health care treat health care as a commodity, a standardized service that can be provided quickly in a formulaic way by "mid-level providers." But won't the service be quick, cheap and to the point?

My concern is that health care is rarely as simple as it seems, especially to people whose health care training was reading financial statements from health care companies. Let's look at an example. One of the maladies which the quick clinics advertise they can treat is the common sore throat. I have actually done some research on this problem, and what I have learned from reading the clinical literature, and my own clinical and research experience is that even this seemingly simple health care problem isn't.

Sure, most, maybe the majority of people with sore throats just have self-limited viral illness, and only need symptomatic treatment (aspirin or the like, maybe throat lozenges, maybe cough syrup, maybe an anti-histamine, fluids and rest). Such people do not even need to visit a clinic. The first problem is that neither the patient nor the practitioner can reliably determine from the patient's symptoms and physical exam whether the patient just has a viral sore throat, or streptococcal pharyngitis (strep throat).

Strep throat can at times lead to serious complications if not treated with antibiotics. Yet the antibiotics used in treating it can have side effects. So even for the "routine" sore throat, the health care professional needs to look at the probabilistic balance of benefits of treatment and harms of treatment. The relevant probabilities, and the importance and value of the particular benefits and harms will vary for different patients. To some extent, this balancing can be rendered formulaic (although the formula may not be simple.) But a failure to understand that the problem is actually somewhat complex and probabilistic could lead to trouble: a patient with a viral sore throat getting a needless antibiotic complication, a patient with strep throat not getting an antibiotic and getting a complication of the disease.

Things get even more complex for a patient with another condition which may affect the likelihood of complications of strep, or of antibiotics. Some common examples of such conditions are asthma, diabetes, chronic obstructive lung disease, and heart valve problems. There are other, less frequent problems on the list. If a health care professional fails to appreciate that the patient with a sore throat has one of these problems (and patients with these problems are not always fully aware of them), then the potential for something major going wrong is even higher. It becomes much harder to set up a formulaic approach that would efficiently screen for such problems, especially because not every patient with them knows he or she has them.

And then there is the issue of rare causes of sore throats....

Other "simple" problems, like urinary tract infections and ear infections, may not always be simple either. And we physicians feel we really earn our money by figuring out when an apparently simple patient isn't.

My real concern about the "quality of care" delivered by quick health care clinics is that the "mid-level providers," good, well-intentioned people with substantial training, but still years less of training than that given to physicians, operating in isolation with corporate pressure to do things quickly and cheaply may miss some of these not so simple patients. And that would be quite bad for the patients. (And when the lawyers figure it out, it would be quite bad for everybody involved.)

Again, those concerned with decreasing costs and improving access might better first focus on the really expensive parts of health care (look at Health Care Renewal and the blogs on our blogroll for some examples). But of course those costs will be heavily defended by vested interests. And the relatively poor, beleaguered primary care docs probably won't make such a fuss about quick quick health clinics, that is, until there own patients end up having bad experiences resulting from such clinics' care.

Of course, it may be possible that quick in-store clinics are just a symptom of larger social ills, and hence may be hard to stop. Let me conclude with quotes from a recent column by Brian McGrory in the Boston Globe:

Oh, I know, I know, every harried mother and overwrought father within Route 495 is undoubtedly thinking that these fast-serve clinics are a going to be a godsend in their mile-a-minute lives. The kid has a rash -- head out to see the nurse practitioner at the CVS, and hey, pick up some Tide while you're at it.

Because that's all we have time for these days, impersonal drive-through treatment centers offering medicine by slogan. As the chief executive officer of MinuteClinic said, 'You're sick. We're quick!'

What's next in their ad campaign? How about 'You've got ills. We've got pills!' And conveniently, you can fill the prescription written by the nice CVS nurse practitioner with the equally nice CVS pharmacist.

It wasn't all that long ago when the average Jane and Joe would take the time to establish relationships with their doctors, who would get to know them inside and out, and doctors would take the time to nurture relationships with patients.

But now look what's happened. Modern technology was supposed to free people up, to give everyone more time.

We can have all the information in the world, but rather than creating the luxury of time, it's causing a constant frenzy. Technology hasn't allowed people to leave their responsibilities behind; it's made people bring their obligations every single place they go.

And thus, the MinuteClinics, guaranteed to be as popular as they are impersonal. So back to my first question: They are merely a symptom, not a cause.

Post Title → Quick In-Store Health Care Clinics: "You're Sick. We're Quick!" but Will You Really Get Better?

Health Wonk Review Hosted This Week on Health Care Renewal

Welcome to Health Care Renewal. We are a multi-author blog which focuses on external threats to health care's core values, especially those due to concentration and abuse of power. Please feel free to browse our main page and archives.

We are proud to host this edition of the Health Wonk Review.

[Addendum 1/11/2007 - Please note - the original version of this post had several weirdly scrambled links. Also, the version put up by Google seemed to have entirely lost one of my citations. In some cases, the link appeared correct in HTML, but was scrambled in the posted version. I have tried to fix all of these problems. If anyone notices any more bad links, please email me a rposes at firmfound dot org. I also added two more citations, one whose submission was lost in the spam filter. Sorry about all that and thanks for the corrections.]

Access and Insurance

On the old version of the Health Business blog, David Williams argued that the rich are not given exceptional health care.

And on the new Health Business blog site, David Williams wondered what the very long wait currently required to see a dermatologist in Boston has to say about the usual arguments (long queues in Canada) against a single-payer health insurance system.

Mike Feehan, on InsureBlog, suggested that the rising prevalence of uninsured patients is an indictment of Medicaid, the US state-federal health care system designed for people who can't afford health insurance.

Jason Shafrin, on the Healthcare Economist blog, reviewed Governor Schwarznegger’s plans for universal health insurance in California, and wondered if they will save costs.

Joe Paduda, on Managed Care Matters, suggested that health care economics is of the “supply-side” variety.

Jon Coppelman, on the Workers’ Comp Insider blog, discussed why health care provided under workers’ compensation insurance costs so much.

Leif Wellington Haase from the Century Foundation , suggested why the idea of universal health insurance may be becoming more appealing today.

James Gaulte, on the Retired Doc’s Thoughts blog , noted the disparity between how rigorously the US Federal Trade Commission (FTC) enforces anti-trust regulation to prevent even small groups of physicians from talking about fees, but ignores how a few large health care organizations, such as hospitals or insurers, may dominate local or regional markets.

And regarding the power of a few large insurers, Graham, on the Over My Med Body blog , described the many reasons California insurers find not to write individual policies for individuals with often trivial diseases, or with “dangerous” jobs.

Matthew Holt, on the Health Care Blog, stirred up some controversy by suggesting that the amount spent on the late US President Ford's medical near the end of his life was inappropriate.

Health Care Management

Marcus Newberry, on the Fixin’ Healthcare blog , suggested that as long as health care is a business focusing on disease, things will not improve.

Information Technology

Shahid Shah, on the Healthcare IT Guy blog, had an invitation for health care bloggers to meet in person at the HIMSS '07 conference in New Orleans.

Pharmaceuticals and Biotechnology

Erik Turkewitz, on the New York Personal Injury Law Blog, had an update on counterfeit drugs.

HS Ayoub, on the BioHealth Investor blog, chronicled the tale of a former drug “pirate” in India which is now going into the international generic drug business.

Paul Howard, on Medical Progress Today, argued that, based on the European example, direct negotiation of drug prices by the US government would stifle innovation.

On the other hand, David Harlow, on the HealthBlawg, suggested points in favor of Medicare negotiating drug prices.

Adam Fein, on the Drug Channels Blog, discussed implications of the Cardinal Health settlement and the issue of counterfeit drugs.

Fard Johnmar, on the Envisioning 2.0 blog , discussed differences in how consumers and pharmaceutical company executives view the industry. He saw pharmaceutical executives as mainly well meaning, but having to cope with an onslaught of negative publicity about the industry. Readers should peruse some of the stories about some of the leadership of the biotechnology and pharmaceutical industry on Health Care Renewal, and think about just how well-meaning they have been, and whether some of the bad publicity was not deserved.

In that vein, Merrill Goozner, on GoozNews blog , noted how the world’s most famous medical journal “de-fanged” an article about conflicts of interest affecting guideline development, in this case, how one large biotechnology company helped to fund the development of guidelines that, surprise, suggested aggressive use of one of its expensive products.

DB, on DB's Medical Rants, discussed the pheonomenon of "too many diagnoses," otherwise know as disease mongering.

“Jack Friday,” on the PharmaGossip blog , announced the debut of the PharmedOut web-site, devoted to teaching physicians more about misleading practices used to market pharmaceuticals.

The Clinical Psychology and Psychiatry blog , commented on how at least one academic physician who worked on trials sponsored by a pharmaceutical company was willing to admit he withheld data from the trial that was unfavorable to its sponsor, and advocated that “industry and academia need to get out of their shared bed.”

Finally, Aubrey Blumsohn, on the Scientific Misconduct blog, chronicled his continuing efforts to get the original data from a drug study for which he was the principal investigator, yet which was withheld by the study's sponsor. This case, which is not well known outside of the UK, is a chilling reminder of how the supposed sponsors of drug trials may try to influence clinical science.

Quality and Safety

On the Antidote: Counterspin for Health Care and Health News blog, Emily DeVoto reviewed recent evidence that the sort of health care quality measures often proposed for pay-for-performance systems for doctors do not seem to correlate very well with some important clinical outcomes.

Rita Schwab, on the MSSP Nexus blog, argued that interviewing physicians for medical staff positions involves medical safety issues.

Summary

We have been delighted to be able to showcase some of the lively discussion of health care policy going on in the blogsphere. We hope it has provided food for thought.

Post Title → Health Wonk Review Hosted This Week on Health Care Renewal

JCAHO Defines (Hospitals' Quality of Care) Deviancy Down

The Los Angeles Times reported how the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has lowered their quality standards for hospitals. Apparently after getting "better-trained inspectors and switch this year to surprise reviews," JCAHO found they were finding more problems when they inspected hospitals. So, Joseph L Cappiello, Vice President of Accreditation Field Operations for JCAHO, said, "we shouldn't deny accreditation to 10 or 15 or 20% of all hospitals in the United States." Instead, they have increased the allowable number of deficiencies.

US Senator Charles E Grassley (R-Iowa), Chair of the Senate Finance Committee, commented, "goverment investigators have already documented that the Joint Commission misses too many serious problems and rarely drops any hospital's accreditation. This move to weaken standards seems to be going in the opposite direction of what makes sense for quality of care."

We physicians hear more and more about how many errors we allegedly commit, and about how our reimbursements will soon be subject to pay-for-performance (see previous post). Yet while physicians feel ever increasing pressure to increase quality of care, when more stringent hospital inspections find more problems, the hospital inspectors decide that they will make their grading standard more lenient. How curious.

The LA Times article did note that JCAHO is paid by the hospitals it inspects, and "owns a consulting business that helps hospitals prepare for its reviews." In a previous post, we also noted reports of other possible conflicts of interest affecting JCAHO. These possible conflicts are important because the federal government has given JCAHO responsibility for most evaluations of hospital quality. Do these possible conflicts of interest have anything to do with what could not be called JCAHO's defining down (hospitals' quality of care) deviancy? Once again, inquiring minds want to know.

Addendum (14 April, 2006): In a letter to the LA Times, Dr Dennis S O'Leary, Presidence of JCAHO, stated that "this article misses the markin in suggesting recent changes ... reflect a relaxation in performance expectations for hospitals." He noted, "the changes in the review threshold are simply designed to assure that the right hospitals are the subject of intensified review. The changes are part of a series of steps being taken to refine the accreditation decision process. Pending their finalization, no adverse decisions for hospitals evaluated in 2006 have yet been rendered. This will begin to happen in May. Because nothing has happened yet, there have been no expressed concerns among accredited organizations about the new process, and the joint commission has received no pressure from any source to make its accreditation process more rigorous."

Post Title → JCAHO Defines (Hospitals' Quality of Care) Deviancy Down

Reasoning by (Mis)Analogy Revisited: How is Health Care Like Manufacturing Toyotas?

As someone who has done a bit of academic work in health quality, an area that has not received a lot of support, I welcome every well-intentioned effort to improve quality. Furthermore, it is reasonable to try to apply lessons learned outside of health to improve health care.
That having been said, I remain troubled that a lot of thinking about health quality seems to depend on drawing misguided analogies. I had previously posted about how the former chairman of Intel likened health care to making computer chips.
The latest example appeared in the New York Times. This op-ed article, entitled, "The Health Factory," asserted that hospitals have a large

opportunity to reduce the rate of catastrophic medical error, if the hospitals would just follow the example of the world's most succesful industrial organizations. Companies like Toyota, Alcoa and Vanguard differ from one another in the products they produce and the technologies they employ, but they share a management approach that has resulted in a combination of safety, quality, efficiency, and responsiveness unmatched by their competitors.
It may seem a stretch to compare a carmaker's , aluminum refiner's, or mutual fund company's operations with a hospital's. But all these companies manage complex processes that require a great deal of problem solving.

To me, it seems a stretch to far. Once again, hospitals do not produce products, they provide services. Moreover, unlike, say a hotel or airline, they must provide unique services to patients who show up at unpredictable times with unpredictable problems, and combinations of problems.
Certainly, there are processes that occur in hospitals that are routine, such as, for example, washing linen or sterlizing surgical instruments. But there is tremendous variability in what goes on in every hospital Emergency Department, operating theatre, medical ward, etc., etc., etc.
It thus makes little sense to think that quality improvement measures designed for businesses whose goal is to produce identical products on assembly lines (e.g., Toyota cars and Alcoa aluminum ingots) are going to apply to most of what goes on in hospitals.
But forcing the application of such measures in situations where they do not readily fit is likely to produce worse, rather than better quality.
Maybe that's why the op-ed cited a single anecdote to support this argument, and started off by wildly inflating the dangers of hospitalization, likening it to "parachuting off a bridge."
I appreciate well-intentioned efforts to improve health care quality, but to be succesful, such efforts need to be informed by appreciation of the health care context.
In a larger sense, thinking about and managing health care as if it were a routine, assembly-line process, as Ludmerer wrote in Time to Heal, like "making cars or breakfast cereals," may be a cause of, rather than a solution to our current health care ills.

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Quality Improvement Organizations: Organized to Address Their Mission?

The Washington Post continued its series on Medicare with a story on Quality Improvement Organizations (QIOs). The story points out some legitimate policy questions about these organizations, particularly related to how their roles have changed as they evolved from "peer review organizations."
Specifically,

• QIOs are apparently still tasked with collecting and addressing patient complaints. However, their current role is mainly to work collaboratively with physicians and hospitals on quality improvement projects. They have been accused of being slow and unresponsive in the face of such complaints, and the number of complaints seems inconsistent state to state. Although they have the power to sanction doctors and hospitals, they rarely do so. The boards of QIOs are made up almost entirely of physicians, but rarely include more than one consumer advocate per state.
• Given that QIOs are tasked to do quality improvement projects, old rules that mandate a high level of secrecy about their work no longer clearly make sense. "These rules even prohibit them from publicly naming the hospitals they work with unless the facilities agree." Why "few do" is unclear. Specific QIOs said "the names and outcomes of their projects are private under their contract with Medicare."

But more in the Health Care Renewal bailiwick, the article revealed that QIOs now provide their leaders very generous remuneration. Forty-one of the state-wide QIOs provided their CEOs with more than $200,000 in total compensation, while eleven provided more than $300,000. The highest compensation, $519,084 pluse use of a BMW, went to Martin Margolies, CEO of PRONJ of New Jersey. Many of their boards are paid, even though in the larger not-for-profit world, board members are rarely paid. At best, such generous compensation may distract leaders from their primary mission.
Although the issues here don't seem as severe as many discussed on Health Care Renewal, many QIOs no longer seem organized to optimally address their mission.

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Reasoning By (Mis)Analogy: Should Hospitals be Compared to Microchip Factories?

Rant alert: I have become increasingly distressed by changes in health care prompted by poor analogies between it and various businesses. One of my pet peeves has been hospital quality improvement schemes based on what purportedly works to improve quality on production lines.
Hospitals couldn't resemble mass production in a factory less. Yes, of course, most products used in hospitals are mass-produced in a factory, and physicians and other health care professionals depend on products manufactured with great uniformity and predictability. Each patient presenting to a hospital, however, has a unique set of problems and issues. Attempts to manage these issues are based on our currently far from complete understanding of human biology, and how psychosocial factors impinge on it. Patients present at any time, with varying degrees of severity, at various stages in their life. The goal is to provide the best approach to each patient customized to that patient's situation and problems. Doing so is likely to require using drugs, devices, and equipment that will perform predictably and reliably. But the choice of what tests to do, what treatments to employ, how to discuss and inform the patient of what is going on, etc are unique to each patient.
In contrast, the goal of production lines is to produce identical products, designed by humans, based on good understanding of physics, chemistry etc., and the principles of engineering. So how would practices designed to improve the design and manufacture of goods and equipment on a production line likely apply to how hospitals take care of unique patients?
In this week's JAMA there appears a good example of the genre of applying industrial production techniques to health care, an article by Andrew S. Grove PhD, the "former chairman of the board of Intel Corporation." [Grove AS. Efficiency in the health care industries: a view from the outside. JAMA 2005; 294: 490.]
Grove starts off with this comparison: "the health science/health care industry and the microchip industry are similar in some important ways: both are populated by extremely dedicated and well-trained individuals, both are based on science, and both are striving to put to use the result of this science." These criteria are extremely broad. One could use them to compare health care with the airline industry, major league baseball, or the Communist Party in the Soviety Union under Vladimir Lenin. All these organizations could have claimed to be populated by well-trained, dedicated people, who based their work to some extent on scientific principles.
Then blithely dismissing that "one industry deals with the well-defined world of silicon, the other with living human beings," Grove goes on to tell us how to do health care better.
Particularly galling, I think, is his criticism of the slow pace of the "war on cancer" compared to the increase in the number of transistors included on microchips.
Maybe he really got to the point nearer the end, when he pushed for more and quicker implementation of the electronic medical record. "When it comes to operational efficiency, nothing illustrates the chasm between the 2 industries better than a comparison of the rate of implementation of electronic medical records with the rate of growth of e-commerce." This comparison is hard to fathom. EMRs, to be useful, need to digitally categorize data that is very hard to organize. No one yet knows how to store, for example, the contents of the medical history in anything other than a text file. Yet an electronic medical record that consists mostly of text and image files may be no easier to manipulate than a paper chart. E-commerce, on the other hand, must simply keep track of stereotyped transactions. (Readers of Health Care Renewal have seen why the EMR may not be as much of a panacea as its promoters proclaim.) But selling more EMR systems may increase the demand for Intel's chips.
I have no objection to inter-disciplinary work. And health care can obviously benefit from insights from other fields. But why are we in health care constantly berated by people based on bearing such bad analogies as those proposed by Grove?

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