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All items for June, 2007


Our Government Knows What to Do. It Just Does Not Do It! Prevention is the Cure

Stanley Feld M.D.,FACP,MACE

The problem is the government can not do it. It is up to us the consumers and electorate to force the legacy systems to change. Alvin and Heidi Toffler’s book Revolutionary Wealth sums it.

In the section on Inertia vs. Hyper speed they say, “As we look at our institutions and how they interact it becomes clear that what America confronts today is not simply a runaway acceleration of change but a significant mismatch between the demands of a fast growing new economy and the inertia of the institutional structures of the old society.”

I think of the government, the insurance industry, the hospitals, big Parma, all facilitator stakeholders as the old society and physicians and medical researchers as the new society.

“Can a hyper speed 21st century information/biological economy continue to advance or will societies slow paced malfunctioning obsolete institutions grind its progress to a halt. Bureaucracy, clogged courts, legislative myopia, pathological incrementalism can not but take their toll.
Something, it would appear would have to give. Few problems will prove more challenging than the growing systemic dysfunction of so many related but desynchronized institutions.”

Why doesn’t the healthcare system do something about the obvious things? They do not do anything about the obvious because the obvious is counter to ossified dysfunctional facilitator stakeholders’ vested interests. The complications of chronic disease are the biggest cost to the healthcare system. Why doesn’t the government mandate payment for systems of care for the complications of chronic disease and the prevention of the onset of chronic disease.

Rather than do something to prevent the complications of chronic disease, these institutions block the innovative progress of the advances in the use of informational and biological technologies. In fact, they punish medical innovation with non payment.

The following are two of hundreds of simple examples to illustrate the point.

Osteoporosis is a chronic, silent debilitating disease that severely reduces quality of life after osteoporotic fractures occur. Only 30% of people eligible for Bone Mineral Density testing presently receive Bone Density testing. We have to do better. Medicare does not pay for Bone Density testing of men. Just as many men have osteoporosis after age 70 as women. Our system waits around until they have a hip fracture. Prevention is cure in osteoporosis. The complications of osteoporosis cost the healthcare system $20 billion dollars per year. Early detection is essential. The mismatch between legacy institutions and science is clear. The government and private insurance institutions are discouraging systems of care for osteoporosis by decreasing the compensation for bone density testing by 75% in the next three years. As soon as these plans were announced the sale of Bone Density machines fell dramatically. The government even found an expert witness to say that Americans’ do not live any longer than people in other country even with our technology. A generalization out of context and unrelated to osteoporosis. The implication is technological advances do not help us save or live better lives.This is disinformation at its best. Apparently, the legacy institutions do not realize that consumers are smarter than they think. With the help of the internet consumers will be able to cut through this disinformation.
Important advances have been developed that have been under utilized or over penalized. The old institutions have not caught up with the speed of info-biological advances.

Another stunning example is that companies have created devices to monitor patients’ vital signs, function and movements at home that can be transmitted electronically to the doctors office in real time. This is a very exciting concept. Not only can people live in their homes longer as they get older, they can be monitored and treated either on the phone or on the internet by their physician in real time. The physician could use his medical judgment to alter medication to avoid congestive heart failure or impending complications of lung disease. This simple act could avoid many emergency room visits and hospitalizations as well as increase the quality of life of the patients suffering from these chronic diseases.

The government and the insurance industry pay home healthcare agencies to collect this data but do not pay the physicians for interpreting the data. As a result this innovative approach to disease management has been underutilized.

In 2001 The American Medical Association (AMA)/ Specialty Society RVS Update Committee (RUC) commented to CMS. CMS had specified that it would consider comments on the Clinical Practice Expert Panel data, the physician self-referral designated health services, and the interim RVUs for selected procedure codes identified in Addendum C. namely payment code (CPT) 99091, a code for reimbursement for physician interpretation of patients collected data. Medicare considered these extra telephone or email interpretations (consultations) as being part of the previous office visit and did not publish the code or reimbursement schedule for non face to face consultation. Finally, in 2007 they published the code but not a payment schedule. Therefore, each consultation for the physician’s opinion requires an office visit. Lawyers and other consultants charge for telephone advise routinely.

The antiquated mentality of the government and the insurance industry is not only costly to the healthcare system, it has discouraged the development of innovative telemedicine. Telemedicine is a valuable technological tool that is slowly appearing in the healthcare system. It can dramatically improve the quality of care and decrease the cost to the healthcare system. What more could a person with head trauma in a distant place want than an expert reading his MRI at 3 a.m. and recommending immediate action.

“Something, it would appear will have to give. Few problems will prove more challenging than the growing systemic, desynchronized institutions. If Americans want the enormous benefits of a worlds’ leading economy the United States will have to root out, replace, or radically restructure its legacy institutions which stand in the way. As change accelerates further institutional crisis will not be limited to the United States.
Some countries my find the threat more difficult than the United States whose culture at least smiles on change makers.”

Consumers are not only smiling on the need for a change in the culture in medicine and the healthcare system. They are fed up with the facilitator stakeholders’ holding them and their healthcare dollar hostage. They are demanding change. All they need is a Pied Piper. Well, the leaders are in your midst, all they need is a posse. You can sign up for my posse at You will receive your official membership card like a Captain Midnight ring.

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Pay for Performance: An Attempt to Standardizing the Standards: Another Complicated Mistake. Part Seven

Stanley Feld M.D. FACP,MACE

In my opinion Pay for Performance (P4P) is code for decreased physician reimbursement. It also represents an attempt by healthcare policy makers to standardize the standards. We can remember Dr Petak’s experience with Blue Cross/Blue Shield of Texas. He was penalized for doing the right thing. He was using a benign medication works for infertile couples. The medication’s was not in the insurance industries algorithm. He saved the patient lots of procedures and the healthcare system thousands of dollars per patient. In thinking about it, quantification of the standards has little to do with the actual medical outcome.

Paying for Performance implies you are willing to pay more for quality medical care than you are for medical care that lacks quality. However, quality medical care has been defined artificially. There are many components to quality medical care. The first is the physicians’ performance and the second and most important is the patients’ performance. If the patient does not do what the physician recommends, the ultimate outcome, the patients avoiding the complications of chronic disease, will not occur. Presently, patient compliance with medication and treatment advice is 45%. None of the healthcare policy wonks thought of this when P4P was invented. Their goal was to impose measurable standards to measure physician performance. They have not developed standards that measure clinical outcomes. The actual clinical outcomes must also be link to social, psychological and financial outcomes. An excellent performance is helping the patients help themselves stay healthy and avoid the complications of chronic disease.

On May 27, 2007 the New York Times Magazine section Ann Hulbert published an
article criticizing the No Child Left Behind Program of President Bush. The title of the
article was THE WAY WE LIVE NOW: Standardizing The Standards
It made me think about what is going on in the P4P experiment. It also brought to mind the Pete Seeger song whose chorus is “When Will They Ever Learn.”

“The president’s signature domestic initiative, now due for its five-year reauthorization, was supposed to be a model of the hardheaded rigor it aims to instill in America’s schools. ”No ‘accountability proposals’ without accountability,” a Bush education adviser declared early on. So one of the most glaring legacies of No Child Left Behind is surprising: it has made a muddle of meaningful assessment. Testing has never been more important; inadequate annual progress toward ”proficiency” triggers sanctions on schools. Yet testing has never been more suspect, either. The very zeal for accountability is confusing the quest for consistent academic expectations across the country.”

There are endless problems reported in the article about standardizing the testing standards for children so that no child is left behind. There is a social science principle called Campbell’s law. ”The more any quantitative social indicator is used for social decision making,” the social psychologist Donald Campbell concluded in 1975, ”the more subject it will be to corruption pressures and the more apt it will be to distort and corrupt the social processes it is intended to monitor.” The article was referring to measuring the performance of public school on the basis of test scores. “With ”high stakes” testing, N.C.L.B. introduces an incentive not to cheat, necessarily, but to manipulate. Signs are that states define proficiency down while schools ramp up narrow test prep. ”Score pollution” — results that reflect intensive coaching — becomes a risk”.

I thought the purpose of education was to teach children reading, writing, and arithmetic. Learning the basics should teach children to think, and solve problems. The goal should not be to get high scores on standardized tests for the maintenance of school funding by the federal government. It represents a pay for performance model for education. In my view, it represents fuzzy thinking.

The author says, “The National Assessment of Educational Progress could serve as a model for a test that judges students’ ability to apply their knowledge and thus discourages rote coaching.” Learning by rote is an invention of policy wonks. In my view, it is not education.

“But recent experience — and Campbell’s law — argues against making test results the sole trigger of federal sanctions. Instead, the data would give states and school districts reliable information on where progress is, and isn’t, happening across the country, to catalyze their own strategies to boost achievement. Rather than cramming to reach an unrealistic target by 2014, states could be more like the laboratories of curricular improvement the country needs”.

The policy wonks ignored Campbell’s Law. They are repeating the same error in medicine with P4P. America sent Dr. Deming to Japan after World War II. He taught the Japanese the concept of continuing quality improvement. Why can’t we do this in education and medicine as well.

“Agreeing on common goals for what kids should be learning can free up teachers to focus more productively on how they could be learning better.”

Education, like medicine, also has two stakeholders. They are the student and the teacher. We have to create an environment of incentives to have both the teachers and the students responsible for their actions and excited about their goals. The methods in NCLB dumb down the system of education and have not produced results. In two words “it failed.”

I predict the same thing will happen in P4P in medicine. The clinical outcomes will be worse. Medical care will be worse. The healthcare system will be dumbed down. The patients will suffer. The healthcare system can not stand another disaster. The healthcare system has to focus on improving clinical outcomes for chronic diseases to avoid their complications. The system should not be imposing requirements on physicians to do certain measurements to get paid. This standardization is foolish. It will turn out to be counterproductive. The two main stakeholders are the patients and the physicians. They are both responsible for the patients’ care. The patients are most responsible and must drive the system. This is one of the arguments for consumer driven healthcare. Consumers are not as stupid as policy wonks think they are. Formulas such as P4P have to be taken out of the hands of the policy wonks and put in the hands of the patients. We must give patients the incentive to do it right by giving them control of their healthcare dollar.

In the treatment of chronic disease it is essential that patients become the professor of the disease with the physicians and their health care teams becoming the coaches that help the patients’ problem solve.
Since 90% of the healthcare dollar is spent on the complications of chronic disease we should be concentrating on developing systems of care (focused factories) that concentrate on the treatment of chronic diseases. The measurement of testing done has little importance. The interpretation of the test results is important. The clinical step taken will influence the clinical outcomes. Pay for Performance represents as perfect opportunity to once again demonstrate that Campbell’s law is true.

Unfortunately, it looks like P4P is a concept developed by technocrats to maintain their importance and value promoting another flawed methodology. It will create more dysfunction in the healthcare system. It is also an excuse for the government and the insurance industry to decrease payment and increase their control over the healthcare system. I predict P4P will increase cost of medical care and decrease the real goal which should be decreasing the complications of chronic disease.

We should be spending money on reimbursed the institution of systems of care that decease the complications of chronic diseases. This is not happening. Physicians must drive these systems of care for it to work. When patients control the healthcare dollar they will pay physicians to develop systems of chronic disease management.

Perhaps hospitals like to treat the complications of chronic disease. It helps their bottom line. Maybe the insurance industry wants an excuse to increase the price of insurance. Once again the goal of medical care system should be to keep people healthy. The emphasis of the facilitator stakeholders is to fix people when they are sick. This must change if we are going to fix the healthcare system.

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Optimism Is The Operative Word. We Can Do It!

Stanley Feld M.D.,FACP,MACE

Our healthcare system is broken. It is not getting better. The dysfunction in the healthcare system increases as time goes by and nothing is happening to fix the system.

I have introduced some “big ideas” in the past year.

The goal is to increase understanding of how the system became broken and what we have to do it. If the ideas necessary to repair the healthcare system are going to work the ideas have to be enacted as a comprehensive package. Unfortunately, this is not the way politicians work unless we are in a meltdown situation. For example, real price transparency of negotiated prices has to be linked to an accurate assessment of quality which has to be linked to patients owning their healthcare dollar and having the ability to chose and evaluate their care. The patients have to be given the ability to negotiate the price with hospitals and physicians or chose an insurance company that will fight to protect expenditure of their healthcare dollars. Patients must be given the incentive to be an informed consumer and educated to spend their healthcare dollar wisely and be penalized if they do not.

Medical practices have to be given the incentives to develop their practices that are dedicated to chronic care of particular diseases (focused factories). The incentives for these focused care clinics must be adequate compensation for their care to make patients professors of their disease. These focused factories will help prevent the complications of chronic diseases. The complications of chronic diseases absorb 90% of the healthcare dollar. There has to be monetary incentives for medical practices to emphasis preventive medicine in order to avoid the onset of chronic disease.

The patients must be responsible for their care and their healthcare dollar. Access to care must not be restricted. Patients are capable of being responsible consumers of healthcare given the appropriate incentives.

Systems of care have already been developed to achieve these goals. I have explained how the Ideal Medical Savings Account as an insurance vehicle can achieve the goal. I do not believe the presently available Health Savings Accounts is a step in the right direction. Health Savings Accounts (HSA) will fail because they lack patient motivation and physician incentives. The failure of HSA’s will move us closer to a single party payer system as a proposed solution. In my view a single party payer system will be a terrible solution for the patients and the physicians.

We will need strong leadership. We need a leader who really understands the problems in the dysfunctional healthcare system. A leader who is not afraid to act contrary to the pressure of facilitator stakeholder vested interests There does not seem to be one around. We will need groups of citizens who are angry enough at the present system who will be willing to demand a consumer driven healthcare system. People power can demand that leadership. First they have to understand the problem and solutions.

Some of the comments I have received in the last few weeks express our generalized cynicism, pessimism and depression about the healthcare system from both patients and physicians.

Paula Hartzell, MD’s sad story in Medical Economics tells it all. It is truly a worthwhile read. I was directed to Dr. Hartzell’s story by KevinMD .Dr. Kevin Pho, a primarycare physician and internal medicine specialist who operates one the top 10 medical blogs in the country. He has a wonderful blog and is providing a great service for both the general population and physicians. If you want to know what is going on in healthcare and medicine read KevinMD. Kevin’s blog provides the information that exposes the ills of the healthcare system and will help stimulate the demand for change.

Richard H. Rowe M.D. is another Family Practitioner who confirms Dr. Hartzell’s story.
“Family practitioner Paula J. Hartzell’s “Medicine is a blame game” [“The Way I See It,” Apr. 20] is sobering. I agree with her commentary entirely.

After 32 years, I am totally disillusioned with medical practice and all the hassles associated with trying to care for patients. Let’s go down the list:
• The government and health insurers blame doctors for overcharging patients.
• The legal profession blames doctors for practicing poor-quality medicine—while these same lawyers are getting rich off the system.
• Regulatory agencies blame us for not doing enough or spending more time in the office.
• Liability insurers blame us for the ever-increasing number of lawsuits.
Meanwhile, organized medicine appears powerless, sitting on the sidelines. If the current trend persists, I am afraid we are heading for a medical meltdown. Perhaps future topics in Medical Economics will be: Where are all the doctors?”
Richard H. Rowe, MD
Mesa, AZ

Richard Rowe M.D. confirms the story as many others have. People must remember when they are sick they want a well trained physician who understands disease processes.

I received some comments as a result of my post” We Are Not Healthcare Providers, We Are Medical Care Providers” saying “you doctors are only trying to protect your guild.” It sounds to me that healthcare providers think physicians are in a turf war with them. As I stated previously the healthcare providers should be called physician extenders. They should be joining the medical care team to provide a team approach to medical care through focused factories rather than trying to compete with physicians and devalue treatment.

I received this comment from a famous oncologist.
“Having worked for several years in a community in which nurse practitioners, physician assistants and oriental medicine physicians (“DOM”) are accorded primary care status by regulatory and insurance entities, I can tell you that they have no clue about disease process. This leads to an enormous number of esoteric laboratory studies and imaging studies in the search of some or ANY diagnosis to explain symptoms. Eventually the patients are referred to a medical specialist and with them come myriads of pieces of unfocused medical data. “..just what is the significance of the elevated serum zinc in the patient with chronic weakness and fatigue who has negative imaging studies?” Nada! Excess healthcare costs and healthcare providers, as opposed to medical care providers, always go together!”

Physicians are calling for leadership to save a broken healthcare system. However, the Democrats think physicians are all crooks. The Republicans seem to make healthcare more profitable for the secondary stakeholders, namely the hospital systems, the insurance industry and big Parma. No leader seems to realize that the patient is the most important stakeholder.

The perception of the people is physicians are making a fortune overcharging us, over testing us, and over treating us with medication that hurt us. They use treatments I can not afford or insurance company will not pay for. Unfortunately, this is the perception generated by all the stakeholders and encouraged by the medias need at sensationalism.

A person who is uninsured wrote; “ I am frightened that I will get sick. I will be stuck with an outrageous hospital bill that will bankrupt me. I am a hard working person who lost my job and can not buy affordable individual health insurance.” This needs to be fixed immediately.

My view is that the consumer of healthcare and the giver of medical care have to unite and force our politicians to do something logical and constructive to change all of this.
Pessimism never got anyone anywhere.

Harry Truman said.” A pessimist is one who makes difficulties of his opportunities. An optimist is one who makes opportunities of his difficulties.”

To the pessimists out there I say read my blog. To the optimist out there I say read my blog. With things as bad as they are, the opportunities for improvement and innovations are limitless and awesomely rewarding both emotionally and financially.

Winston Churchill said,” I am an optimist. It does not seem too much use to be anything else.

Franklin Roosevelt said, “The only limit to our realizations of tomorrow will be our doubts of today.”

Ronald Reagan said “There are no great limits to growth because there are no limits of human intelligence, imagination, and wonder.”

Finally, Dwight D. Eisenhower said “Pessimism never won any battle.”

Our most valuable possession is our health. We must be optimistic in the battle to save the medical care system by reformatting the healthcare system. A system needs to be developed that protects patients, the most important stakeholder in the medical care system, not a system that protects the vested interests of the facilitator stakeholders in the healthcare system. The facilitator stakeholders add little value to our medical care system.

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Women’s Health Initiative (WHI): Medical Community Undermines Itself

Stanley Feld M.D. FACP.MACE

This blog entry is dedicated to Joseph Goldzieher M.D. one of the giants in Reproductive Endocrinology.

The Women’s Health Initiative is perhaps the most famous example of a study that was released to the press before the data was published in a medical journal. The conclusions of the study changed forever the way peri-menopausal and post menopausal women are treated.

The pre-published press conclusion was that estrogen causes heart disease, breast cancer, stroke and pulmonary embolism. The media announced the WHI’s findings before the medical profession had a chance to study the data.

The conclusions frightened every peri-menopausal and post menopausal woman in this country. Over the years observational data supported the conclusion that estrogen was of great value in treating symptoms associated with the acute menopausal syndrome, namely hot flashes, vaginal dryness, urinary tract irritation, skin changes and emotional instability. Estrogen also seemed to protect against heart disease, osteoporosis, weight gain and promote a general sense of well being. There was no good evidence for or against breast cancer.

This NIH sponsored double blind placebo controlled study (WHI) was performed to develop proof with a level A(double blind placebo controlled) study to test the validity of observational data reports of estrogen effects. The WHI reported results that concluded the opposite effects of estrogen reported by many observational studies. The WHI conclusions were that conjugated estrogen caused breast cancer, heart disease, stroke, and pulmonary embolism. The WHI claimed that conjugated estrogen did protect against osteoporosis. You will recall the media is the message and these were the results the media frenzy reported.

Prior to release of the study results many women were afraid to take estrogen on general principles alone. Many felt that estrogen deficiency was part of the aging process. However, women had a life expectancy of 50 years in the early part of the 20th century. Women today live much longer and observational data suggests healthier, as a result of estrogen therapy.

There are many problems with the WHI study that have not been discussed in the popular press. These problems have not been discussed in the medical literature either. Practicing physicians were confused and enraged by the WHI study results and the manner in which they were presented. Patients taking estrogen were angry at their physicians.

There are many defects in the study from a statistical point of view.

1. Age Distribution: 66.6% of the patients were between 60 and 70 years old. 87% of the patients were 60 to 80 years old. The majority of the patients receiving Hormone Replacement Therapy (HRT) for the first time were at least10 years post-menopausal. This age group population does not represent the usual population for starting HRT. HRT is usually started just prior to the onset of menopause or at menopause (48 years old).

2. The drop out rate in the placebo and HRT group was 40%. The impact of the dropout rate was not addressed in the validity of statistical analysis section of the paper. Maximal tolerable dropout rate should not be greater than 20% in a statistically significant protocol.

3. The unblinding of 3000 women represents a departure from the protocol and biased the findings of treatment difference.
4. A hazards ratio (HR) should be greater than 2 in order to have for a result to have convincing difference and should not be expressed to two decimal places. A hazards ratio of less than two can not discriminate causality from bias and confounding of variables.

5. Power of the study was disrupted by the 40% drop out rate. The study was not sufficiently powered to have significant results

6. The traditional approach to presenting a nominal confidence interval is valid when one outcome is being studied against a placebo. Adjusted confidence intervals must be used when studying multiple outcomes with multiple confounding variables.

The WHI’s conclusions were based on the use nominal confidence intervals. The nominal confidence intervals were significant. However they came close to touching the magic number one (1). All of their published adjusted confidence intervals were non significant because they crossed 1.

Estimated hazard ratios (HRs) (nominal 95% confidence intervals [Nom CIs] and adjusted 95% confidence intervals [Adj CIs ) were as follows:

CHD HR 1.29 Nom CI (1.02-1.63) Adj CI 0.85-1.97
Breast cancer HR 1.26 Nom CI(1.00-1.59) Adj CI 0.83-1.92
Stroke HR 1.41 Nom CI (1.07-1.85) Adj CI 0.86-2.31
PE HR 2.13 Nom CI(1.39-3.25) Adj CI 0.99-4.56

The adjusted confidence intervals were published in the original paper.

Media blitz publicity of the results of the study created a high level of certainty for the results of the study in the public’s mind prior to any peer discussion of the data or the weaknesses in the data. Few physicians were in a position to dispute the statistical weakness of the data. The results the media reported were to change forever the way physicians practice medicine for menopausal women. In my view, the results led to a great disservice to women. The publicity also had a devastating impact on the physician patient relationships and the patient confidence in clinical research.

The estrogen only leg of the study showed no significant difference in breast cancer or heart disease. These results and the facts related to the result was less publicized by the media.

The conclusions of the data should have been that the study results were not related to the combination of conjugated estrogen and progesterone in PremPro or the conjugated estrogen alone in Premarin. Even though estrogen might cause heart disease, pulmonary embolism, stroke, and breast cancer, the Women’s Health Initiative did not have the statistically significant evidence to prove it. Once again media published conclusions disrupted the therapy regime of millions of patients as well as their confidence in their physicians. Once again, physicians contributed to the dysfunction of the healthcare system.

Freedom of the press is vital to our freedom of speech, but manipulation of the media’s tendency to sensationalize issues prior to proper judgment is not helpful.

  • Alexis Kenne

    Doctors now know that heart disease is so deadly for women that their chances of dying from it are one in two. That means basically that either you or your best girlfriend is likely to die of a heart attack, stroke , or related heart problem. Doctors have traditionally used a one-size-fits-all approach to identifying and diagnosing heart disease. In this view, women often lack the “classic” signs of reduced blood flow to part of the heart, a condition known as ischemia. Doctors and patients often attribute chest pains in women to noncardiac causes, leading to misinterpretation of their condition. Men usually experience crushing chest pain during a heart attack.

  • Jessica Connorth

    Nice article. Nomore hormone replacement .Don’t let menopause ruin your quality of life! There are many remedies for weight gain anxiety and menopause symptoms. Natural ways are available:

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The Reversal of the Trend: Hospital Systems Stop Buying Physicians Private Practices

Stanley Feld M.D., FACP, MACE

The control of the healthcare system is dominated by the insurance industry, the government, hospital systems and pharmaceutical companies.

One of the reasons hospital systems bought physicians practices was to have control over ancillary services generated by the physicians’ intellectual property. These ancillary services are laboratory services, CT scans, MRI scans, cardiac catheterization labs and ECGs.

The business of medicine had become too complicated for most physicians. Physicians who sold their practices to hospital systems did not realize they could not make a living without the revenue from ancillary services. Physicians retreated to the safety of hospital guaranteed salaries without realizing they were giving away their intellectual property the only property they had to sell. Physicians reacted when they realized that the hospital systems were generating undo profit from their intellectual property. Physicians also realized that hospital systems were inefficient in operating some of the ancillary facilities. These services were more convenient for their patients in physicians’ offices. The result was inefficient care to their patients.

On the other hand, many hospital systems learned they could not make any money from physician productivity. The hospital systems guaranteed the physicians the salary they had generated before the practice buyout. The hospital systems are now giving the physicians back their practices. The hospital systems lost their cash buyout of the physicians’ practice. It would not be surprising to me that this loss was billed back to the patient in the form of cost of service. We cannot figure out the actual cost of services.

The focus of the hospital systems was changed from ownership to management of the back office duties such as billing, hiring, firing, and paying the rent. Hospital systems also demanded that the physicians used their hospital facilities.

Another round of physicians’ reaction is in the offering. Physicians are starting to realize that the hospital system is overcharging physicians for back office services. Hospital systems require physicians to use the hospital systems inpatient facilities.

The large physician groups now own the revenue generated by several ancillary services. They are benefiting from the use of their intellectual property. However, physicians are realizing they are not getting their fair share of the revenue they are generating. In many cases their practices are being overcharged for overhead, payroll, rent and administrative services. The thinking by hospital systems advisors was that younger physicians would not be as interested as older physicians are in how the business is handled. I think the hospital systems are going to be in for a big surprise. A sleeping giant is slowly awakening. Especially when the younger physicians are realizing that the hospital systems are under coding and under collecting for their physician services and not billing a professional fee for ancillary services. The result will be that physicians will demand they control their overhead and their billings. The problem for the hospital systems is that management of physicians’ offices was a nice profit center. With less inpatient services needed and the increase in brick and mortar investment over the last ten years, hospital systems are going to be in a cash flow bind.

The physicians’ goal is to practice the best medicine they can while earning a living consistent with the value of their intellectual property is worth. The level of mistrust that physicians have for hospital systems is simply going to intensify when they find out what is happening to them financially. The hospital system- physician relationship will shift from bad to worse.

Physicians’ control of their overhead, in my opinion, is good shift during the changes healthcare undergoing. In the changing environment toward consumer driven health care and the patients owning their healthcare dollar, the physicians controlling their own practice overhead, the result can be an enhanced relationship between the primary stakeholders the patients and the physicians. Competition for patients will create physician incentives to force physicians to become more efficient. Physicians will adopt EMR’s more rapidly in an attempt to increase the level of efficiency and service.

Competition will motivate physicians to increase quality and lower price. Focus factories will develop in Family Practice offices. New mechanisms for building healthcare teams for the creation of systems of care to prevent the complications of chronic disease will occur. The result will be a decrease in complications of chronic diseases. Prevention of chronic disease will also be increased because patient will demand preventative services. They will compensate physicians for the preventive care. I can envision physician being compensated telemedical communication systems to avoid frequent office visits and hospitalization. I can imagine an increased compliance with treatment and a demand for effective patient education when the patients understand that they own their healthcare dollar.

Presently, there is no insurance mechanism to compensate physicians for preventative care. I see a bright future for patients, physicians, the physician extenders and the secondary stakeholders. The losers will be the administrative waste and avoidable and expensive services rendered for the complications of chronic disease.

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What Has Happened To The Medical Professions Ability To Apply The Scientific Method To Our Medical Articles?

Stanley Feld M.D.,FACP,MACE

This entry might be a little over the top for many of my readers. However, it is an important entry for our understanding of how the medical profession is contributing to the dysfunction of the healthcare system.

There is much skepticism about the medical profession. I have avoided discussing my professions problems so far. The profession has created many of its problems. Our own colleagues have undermined our own credibility with the publication of flawed scientific articles that have resulted in uncertainty about medical treatments. This subversion decreases patients’ confidence in the medical community’s ability to treat patients’ problems effectively. Public sensationalizing by the media of the contradictory results of clinical research has undermined the patient physician relationship. The re-evaluation of clinical research results has led to contradictory conclusions since the beginning of modern medicine. The constant testing of results and hypothesis is a good thing. We have always been searching for the truth through more objective scientific information.

It seems to me that recently there has been a loose use of statistics in interpreting clinical research, leading to inaccurate conclusions. These conclusions are broadcast and publicized by the media as truth before the conclusions are carefully evaluated by the medical community. In our sound bite society the conclusion counts and not the facts.

I have concentrated on the problems the facilitator stakeholders impose on effective medical care in a dysfunctional healthcare system. It is appropriate to point out some of our intra-professional contributions to the dysfunction of the healthcare system.

Steven Nissen M.D. and Kath Wolski M.P.H. of Cleveland Clinic published an article, “The Effect of Rosiglitazone On The Risk Of Myocardial Infarction And Death From Cardiovascular Causes.” The New England Journal of Medicine published the article. The publication of this article, in my view, contributes to the dysfunction of our healthcare system. The article misrepresents evidence based medicine. Evidence based medicine has become the holy grail of medical practice. Evidence based medicine is gleaned from the published medical literature. It includes commentary and review of the evidence by experts in each field.

According to the Centre for Evidence-Based Medicine, “Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” The operative words are “use of current best evidence.”

There are three problems with Dr. Nissen’s paper. The design of the study is flawed. The collection of data is incorrect. The results derived from defective data are not statistically significant.

Marshell McLuhan pointed out that “The Media Is The Message” in his landmark book of 1967.

The NEJM has been criticized in the past for pre-releasing information to the press, before the medical community has a chance to evaluate the quality of the information. The medical literature judges have also made mistakes in evaluating data in the past. In my opinion, they have once again made a mistake with Dr. Nissen’s article. The public prejudgments are developed by media stories. The media broadcasts the results (sound bite) and not the facts. The media is the message!

The media loves to expose the deficiencies of the medical profession, the healthcare system and the Federal Drug Administration. Every federal agency is hobbled by bureaucracy. We all realize it. It is one of the reasons will mistrust putting the responsibility for our healthcare in the hands of government. However, sometimes the FDA is criticized unfairly. The unfair criticism receives a lot of media coverage even if the facts are incorrect.

Dr. Nissen and others have criticized the FDA for its inadequacy of evaluating new drugs in general and rosiglitazone in particular because of the results of his study. “The FDA considers demonstration of a sustained reduction in blood glucose levels with an acceptable safety profile adequate for approval of antidiabetic agents. However, the ultimate value of antidiabetic therapy is the reduction of the complications of diabetes, not improvement in a laboratory measure of glycemic control. After the failure of muraglitazar and the apparent increase in adverse cardiovascular outcomes with rosiglitazone, the use of blood glucose measurements as a surrogate end point in regulatory approval must be carefully reexamined,” Dr. Nissan writes.

I agree with Dr. Nissen. A surrogate measurement of a drugs effectiveness is not as precise as the measuring the direct outcome of namely decreasing the complications of Diabetes Mellitus. However, in the DCCT study of 1993the surrogate measurement of blood sugar control (HbA1c) has clearly demonstrated a reduction in the complication of diabetes mellitus. It is totally acceptable to use this information in subsequent studies.

Dr Nissen’s view about the FDA is shared by Psaty and Furberg, who write: “Ongoing trials using rosiglitazone may provide important new data, but for a drug approved in 1999, the delay in obtaining information about health outcomes has already been considerable.” They add that tens of millions of prescriptions for rosiglitazone have been written, and if the current findings represent a valid estimate of the risk of cardiovascular events, rosiglitazone represents a “major failure of the drug-use and drug-approval process in the United States.”

I do not believe that Dr. Nissen’s findings are an estimate of the risk of cardiovascular events with the use of rosiglitazone. Perhaps it is not a failure in the drug-use and drug approval process used by the FDA. It is in the lack of validity of the results of Dr. Nissans’ paper that should be criticized.

Dr. Steven Nissen’s recent paper promotes the distrust of the medical profession and its regulators. The medical profession did not have a chance to evaluate this evidence before it was prejudged in the media. Dr. Nissen has been on network and public television and radio multiple times. Sensationalism in clinical research only serves to decrease the confidence of the public for the value of clinical research.

1. The design of the study is flawed

The study subjects were derived from a meta-analysis. A meta-analysis is an analysis that combines all studies on a subject into one study. The goal is to derive a larger population than each individual study. The purpose of a meta-analysis is to see if an adverse event that is statistically significant is occurring that was not apparent in smaller studies.

The concept of meta-analysis was introduced to clinical medical research in 1992. Most of us never understood the value of meta-analysis in medicine. The design of the various studies combined usually do not have matching protocols. Dr. Nissen’s study combined studies with varied protocols. In fact, similar studies that had no adverse effects either from the placebo or treatment side were eliminated from his meta-analysis. The inclusion of these studies in the meta- analysis might have diluted the effect he was seeking making his results less statistically significant. His data should be reevaluated including these data.

2. The collection of data is incorrect.

Dr. Nissen pointed out the shortcomings of the meta-analysis.” They point out that this meta-analysis is limited by a lack of access to original source data, which would have enabled time-to-event analysis, and on a relatively small number of events (there were 86 MIs and 39 cardiovascular deaths in the rosiglitazone patients vs 72 MIs and 22 cardiovascular deaths in control patients). But they say that despite these limitations, patients and providers should consider the potential for serious adverse cardiac effects of treatment with rosiglitazone.”

I agree, but by his own statistical analysis cardiovascular deaths were not significant and myocardial infarction results were barely significant.

3. The results derived from defective data are not statistically significant.

In order for a result to be statistically significant the confidence interval should not cross one(1). In the analysis of cardiovascular death the confidence interval crossed 1. (C.I. 0.98-2.74). A p value of .06 is not significant. p value should be no greater than 0.05

The C.I. from the analysis of myocardial infarction almost touched 1. (C.I. 1.03-1.98). A p value of .03 is barely significant. Many statisticians believe a significant odd ratio must exceed 2 to be significant. The odds ratio for cardiovascular death was 1.64 and for myocardial infarction 1.43. Those odds ratio numbers are strange because the non significant finding of cardiovascular deaths odds ratio is closer to 2 and a greater trend toward significance, than the barely significant findings of myocardial infarction.

If Dr. Nissen did not remove the clinical trials that did not produce adverse effects in his meta-analysis, the total number of patients in his analysis would be increased and would probably have changed the myocardial infarction confidence interval so that it would cross 1 and p value above 0.05 making the result non significant.

All of the patients in the studies retained were poorly controlled diabetics with HbA1c levels above 8%. Normal should be 6% or below. A high HbA1c alone would increase the incidence of myocardial infarction and cardiovascular death. There is no indication of the distribution of the HbA1c control in the multiple populations. A criticism is that there are two many confounding variables in this studies that can result in an increase in myocardial infarction and cardiovascular death. These confounding variable are not examined independently among the studies. Focusing on one end point, the effect of rosiglitasone on myocardial infarction and death from myocardial infarction without consideration for varience of the other variables is unacceptable.

Rosiglitazone might cause an increase in myocardial infarction and cardiovascular death. However, Dr. Nissen’s paper did not demonstrate this relationship. The public and patients on rosiglitazone have be confused by being presented with the results without rigorous scientific critique of the study.

The confidence of the public in medicine has been shaken by the method of presentation of the results. There have been other effective medications that have suffered the same consequences. The consequences of prejudgment of the results without scientific comment have deprived the public of effective treatments in the past.

In my view this decreases the confidence the public has in the medical care system and adds to the dysfunction of the healthcare system.

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We Are Not Healthcare Providers! We Are Medical Care Providers!

Stanley Feld M.D.,FACP,MACE

The term healthcare provider, in my view, has been constructed to decrease the value of physicians. The goal is to decrease reimbursement and distribute reimbursement for medical care delivered by physicians to others. The physician is now in the same category as the nurse, nurse practitioner, physician assistant, pharmacist, physical therapist, occupational therapist and dietician, to name a few. We are all referred to as healthcare providers by secondary stakeholders.

Several states now permit these ancillary providers to bill independently of the physicians. I believe to treat chronic disease effectively it has to be done as a coordinated team approach with the patient as the most important person in the team and the team leader the medical doctor. Everyone on the team has to have the same focus. The goal is to provide a holistic approach to the patient’s illness and to enable patient’s to become professor of his disease. This is a focused factory. A focused factory team approach to chronic diseases will increase the quality of care given and decrease the cost. The members of the team, the nurses, nurse practitioners, physician assistants, pharmacists, physical therapists, occupational therapists and dieticians should be physician extenders not healthcare providers competing for the patient’s healthcare dollar. A multidisciplinary team approach is essential for the coordination of education and care for the patients with chronic disease. Contradictory instructions given by individual healthcare providers simply serve to confuse patients and not add value to their intensive self management.

The implications, as well as notions, are that these healthcare providers can be physician substitutes providing cheaper care than a physician controlled team. We are presently seeing this trend as Nurse Practitioners and Physician Assistants run Doc in the Boxes in pharmacies and supermarkets for private non medical corporations. The Doc in the Boxes are advertised as centers providing inexpensive, convenient, and rapid medical treatment.

All of the healthcare providers are very important to the healthcare system. However, from a responsibility for care as well as patient safety point of view, these healthcare providers should be called physician extenders and not have equally status to physicians. The compensation for these other healthcare providers should be billed through the physician’s office with physician having the responsibility for effective, safe and quality care. Physician extenders should not have stand alone practices.

These healthcare providers have been licensed by some states to do procedures, examinations and consultations. In the past these duties were the physician’s responsibility. I have doubts about the clinical judgment of these healthcare providers.

The “instant frog” story is appropriate. It takes two weeks to hatch a frog from a tadpole. If you put a tadpole in a petri dish and put thyroid hormone in the petri dish, you can produce something that looks like frog in thirty six hours. This analogy can be applied to healthcare providers who have not had the breath of education, experience, and time to develop the clinical judgment that physicians have had. Therefore it is unwise to equate an instant healthcare provider to a fully developed physician.

If these “Doc in the boxes survive, we as a society will be making a great mistake. As a society we have invested a great deal of money in developing our physician work force. Today, Family Practitioners are having a hard time surviving. They are not permitted to produce income generated from ancillary services for their intellectual property on the one hand, and are being challenged by healthcare providers who are compensated for private practices on the other hand.

We as a society do not realize it yet but we are about to destroy a precious resource for the sake of the corporate bottom line. If physicians are inefficient in the delivery of care, we ought to teach them how to deliver efficient care and not destroy them. If we do, we are destroying 6-8 years of graduate education and the clinical judgment developed in that process.

We need to rethink our present path.

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The Most Important Stakeholder in the Healthcare System: The Patient!

Stanley Feld M.D.,FACP,MACE

The hospital systems and the insurance industry have archaic and unscientific methods of determining price. The combination of the methods of pricing and the excess cushion built into the price leads to the excessive profits, salaries to executives and excessive building and remodeling. I look at this as creating a perfect opportunity for creating a competitive environment on pricing between hospital systems and between hospital systems and physicians practices. It also is a perfect environment for insurance companies to compete with each other. The result would be lower premium prices. If one insurance company made a move to lower prices, increase efficiency and decrease consumer grief, the others would follow. The insurance industry has some leeway on pricing because of their excess profits. Naturally, hospital systems and insurance companies do not want to give up this profit advantage. This is the reason hospital systems and insurance companies have lobbyists in State Governments and in the Federal Government. When consumers are in charge of their healthcare dollar and can profit from its wise use, they will force the insurance industry to lower prices.

All that is need is to pass a few rules and regulations by the politicians in government to create this price competition. The rules would include present price transparency, reporting on the methods used to determine the prices for hospital services and the price of premium creation, as well as the patients’ access to this pricing mechanism. If the politicians in government had the courage to act on these suggestions the mess in the healthcare system could clear up very quickly.

The people and not the insurance industry should have control of their healthcare dollar. If the people use the control over their healthcare dollar wisely, the money saved would grow in a tax free trust account each year to be used at retirement. This concept is embodied in my ideal medical savings account. The insurance companies would adjudicate the claim. However now it would be done instantly decreasing administrative costs for the insurance companies, the hospital system and the physicians. They would continue to negotiate the best fees for the patient. If they did it poorly the people would move to another insurance company. They would receive the privilege of holding the insurance premium and the trust account money. They would provide pure insurance if an illness cost more than $6,000.

Community rated group insurance would be available to all with pre-tax dollars. People would can not afford insurance would be supplemented by the government. This form of insurance would also apply to Medicaid and Medicare. It would be universal healthcare in a consumer driven and controlled system rather than universal health care in a single party payer system.
Doing all this at once would force the hospital systems, the insurance industry and physician to be more efficient. It would accelerate the development of the ideal EMR and decrease money wasting inefficiency in the healthcare system.

The most important stakeholder in the healthcare system is the patient. Somehow, the patient has been converted from a person with an illness and needs medical care, to a person who is a potential financial asset to the facilitator stakeholders. It is not uncommon, in the halls of facilitator stakeholders to hear patients referred to as clients, lives and eyeballs. “The more lives you have in your healthcare system, the greater the revenue and the greater the profit.

Without patients there would not be a healthcare system. The conversion of patients to economic entities is partly a result of the advances in technology and partly the dysfunctional evolution of the healthcare system. CAT scans, MRI scans, and stress echocardiograms and others have served to make the patient a commodity. All these test procedures generate revenue. The organization performing the testing generates the revenue. If patients owned their healthcare dollar, prices for services were transparent, and physicians’ offices were able to compete with hospital systems for procedures that are presently not permitted in the physician offices, all the stakeholders would be driven to more accurate pricing and more efficient care. The price of care would drop. The Lasik procedure is a perfect example of prices dropping in a consumer driven competitive marketplace.

At the same time, the government and the insurance industry are complaining that the physician does not practice evidence based medicine. Patients ought to have a mammogram once a year, a colonoscopy every five years, and a bone mineral density every two years, to name a few preventative screening tests.

The reality is that the increased technology has lead to increased accuracy in early diagnosis and early treatment. The result is a decrease in complications of chronic disease. The complications of the disease absorb 90% of the healthcare dollar. The technology has increased the diagnostic skills of the physicians. However, with the restrictions imposed by the facilitator stakeholders to not allow the physicians to do the testing in the office, and the inefficiencies of getting a hospital system scheduled procedure prevents the physicians from consistently practicing evidence based medicine. The implication is if the physician was permitted to do the test in his office, the physician would over test. This implies physicians are crooks and will take advantage of the patient. Ninety eight percent of physicians aren’t crooks despite what Pete Stark (D-Cal) says. It is easy to stop that 2%. However, the inefficiency in the healthcare system does not permit the physician to give appropriate preventive care to the patient.

Cognitive services are essential to accurate diagnosis and treatment. Yet, the skills these cognitive services have been devalued in recent years. In fact, if payment for cognitive services was the only revenue a physician could generate he would not be able to pay his overhead. This is presently a crisis Family Practitioners are now facing. It seems obvious, that in order to increase ones revenue, one must do indicated ancillary procedures. The counter argument is the physician will be given the incentive to over test. If a test is done in the hospital systems the cost of the procedure is usually higher than when it is done as an office procedure. (remember Dr.David Westbrock’s example). Physician office testing would drive the hospital system prices down if the hospital system wanted to be competitive. It is in the vested interest of the hospital system not to permit a competitive environment. If purchasing of healthcare services was in the hands of the patient they could choice the provider and force a competitive environment.

Physicians have the privilege of helping patients who are ill get well. They also have the obligation to prevent disease. It is not only a privilege, it is an awesome responsibility. Physicians are medical doctors that provide medical care. Medicine is a princely profession. Physicians must be given to tools to provide efficient and effective care at an affordable price. The marketplace through patient control should decide the price. Hospital systems and insurance companies arbitrarily made up the price in the past. This has to stop.