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All items for April, 2015

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Obamacare Is Not In The News

Stanley Feld M.D.,FACP,MACE

There has been little reporting about Obamacare in the traditional media lately. I believe it is intentional.

President Obama doesn’t want to talk about it. He has told us Obamacare is a success. The problem is he has left out the facts about its failures, costs and disruptions.

Last week a 70 plus year old woman wrote and told me that none of her brand name medicines are being covered by her high level Medicare Part D plan because of Obamacare regulations.

She said out of pocket expenses for her generic drugs have doubled in her in the past two years.

I found it hard to believe because there has been nothing reported about this in the traditional mainstream media.

Out of pocket expenses are beyond the reach of many Medicare recipients.  

A big out of pocket expense for many has been the cost of signing on to a concierge medicine doctor in some cities in the country.

The most prominent city is Los Angeles. I have been told that  primary care physicians will not see a patient that does not sign on to their concierge panel at a cost of $1500/year.

To my surprise Thomas B. Edsell a very liberal (progressive) United States journalist and academic, best known for his weekly opinion column for the New York Times online and for his 25 years of covering national politics for the Washington Post wrote two articles about the problems with Medicare and Obamacare.                        

The first article Obamacare, Hand Off My Medicare points out that President Obama is destroying Medicare.

The second article is entitled Has Obamacare Turned Voters Against Sharing the Wealth?”

Both articles state, in detail, reasons and excuses for Obamacare’s failures.

Here are just a few reasons and excuses.

“A number of factors underpin the anti-redistributionist shiftin public opinion that I wrote about last week.

First, and perhaps most important, is the emergence of significant resistance to downward redistribution among the elderly, a major voting bloc.”

How come this trend is occurring? It is because seniors of modest means are threatened. They are realizing Obamacare is a bad law with many defects.

“The Obama administration has reported that the Affordable Care Act will be financed in part by $716 billion in Medicare cuts over 10 years.

 Somewhat improbably, the administration also contends that cuts of this magnitude will not reduce services to Medicare beneficiaries.”

Another President Obama lie. Seniors are already feeling the Medicare cuts by a decrease in access to care and an increase in out of pocket expenses.

Seniors have learned that they cannot trust President Obama to preserve Medicare.

“Seniors have started raising concerns about the cost of these plans — higher taxes and premiums for those with coverage, more government interference in physician choices.”

These concerns are real and present.

 “Further increasing anxiety among the aged in the United States is the shift from defined benefit pensions, which guarantee payments, to defined contribution pensions, which do not.”

If Medicare shifts to a defined contribution policy, seniors are afraid if they live longer they will run out of money.

Obamacare is unsustainable. Once President Obama losses public trust any idea no matter how good it was thought to be in the past will not be supported.

The reasons for Obamacare’s failures were predictable before the bill was passed. I have written many articles giving reasons for its failures.

Now President Obama is setting up the public with excuses for its failure through these New York Times articles.

The President’s next step is to declare that Americans have to live with Obamacare because the Republicans have not come up with anything better.

President Obama does not listen to Republicans even when they come up with reasonable ideas.

This predictable step is taken to brain wash the public to accept a law that empowers the government to make the public more dependent on government and less free to make their own medical choices and decisions.

Seniors are starting to act out now because Obamacare, with its redistribution of their wealth, is hurting them economically and is not in their vested interest.

Seniors should start understanding how President Obama has given favors to the healthcare insurance industry, the pharmaceutical industry and the hospital industry at seniors’ expense. Once they understand, seniors will not support President Obama.

Seniors are a big voting block. They represent a large threat to the Progressive Democratic Party and its foolish laws and tactics.  

 The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

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How Should Healthcare Quality Be Measured?

Stanley Feld M.D., FACP,MACE

 The U.S. Preventive Services Task Force’s (USPSTF) grading system for measuring the quality of healthcare is an wrong. It results in a way to limit physicians’ judgment and treats medical care as a commodity. It enables a computer program to judge if physicians have followed an algorithm to treat patients.

 “The U.S. Preventive Services Task Force (USPSTF).[57][citation needed has developed grading systems for assessing the quality of evidence for making judgments about treatments. 

  • Level I: Evidence obtained from at least one properly designed randomized controlled trial.
  • Level II-1: Evidence obtained from well-designed controlled trials without randomization.
  • Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
  • Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
  • Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.”

The grading system is wrong. I will lead to shabby medical care. If quality of care should be measured, it should be measured by using Evidence-Based Behavioral Practice evaluations

 “Evidence-based behavioral practice (EBBP) "entails making decisions about how to promote health or provide care by integrating the best available evidence with practitioner expertise and other resources, and with the characteristics, state, needs, values and preferences of those who will be affected.”

Empirically supported treatments (ESTs) in some clinical settings are defined as "clearly specified psychological treatments shown to be efficacious in controlled research with a delineated population" [3]

Only when physicians’ clinical judgment and observations are included in the assessment of their quality of medical care should evaluation of that quality of care be measured.

The narrow criteria of the USPSTF will not define quality. It will only serve to restrict access to care and penalize physicians for using clinical judgment and consumers’ from receiving medical care.

Suddenly, it becomes easy to see how difficult it is to assess the quality medical care.

There is little question that an occasional physician practices terrible medicine. This is obvious to the medical community. The mechanism for improving a bad physicians quality of care is in place but not well executed.

Few, especially healthcare policy wonks, seem to understand the difficulty of assessment of medical care.

It should be easy for policy wonks to understand the limitations and criticisms of evidence based medicine.

Yet the Obama administration regards evidence-based medicine as measured presently as the gold standard of clinical practice,

Limitations and Criticisms of Evidence-Based Medicine (EBM)

  • EBM produces quantitative research, especially from randomized controlled trials (RCTs). Accordingly, results may not be relevant for all treatment situations.[67]

This is obvious to most physicians.

  • The theoretical ideal of EBM (that every narrow clinical question, of which hundreds of thousands can exist, would be answered by meta-analysis and systematic reviews of multiple RCTs) faces the limitation that research (especially the RCTs themselves) is expensive; thus, in reality, for the foreseeable future, there will always be much more demand for EBM than supply, and the best humanity can do is to triage the application of scarce resources.

The reasons for EMS shortcoming are listed below. The list is not complete.

  • Because RCTs are expensive, the priority assigned to research topics is inevitably influenced by the sponsors' interests.
  • There is a lag between when the RCT is conducted and when its results are published.[68]
  • There is a lag between when results are published and when these are properly applied.[69]
  • Certain population segments have been historically under-researched (racial minorities and people with co-morbid diseases), and thus the RCT restricts generalizing.[70]
  • Not all evidence from an RCT is made accessible. Treatment effectiveness reported from RCTs may be different than that achieved in routine clinical practice.[64]
  • Published studies may not be representative of all studies completed on a given topic (published and unpublished) or may be unreliable due to the different study conditions and variables.[71]
  • Research tends to focus on populations, but individual persons can vary substantially from population norms, meaning that extrapolation of lessons learned may founder.
  •  Thus EBM applies to groups of people, but this should not preclude clinicians from using their personal experience in deciding how to treat each patient. One author advises that "the knowledge gained from clinical research does not directly answer the primary clinical question of what is best for the patient at hand" and suggests that evidence-based medicine should not discount the value of clinical experience.[56] Another author stated that "the practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research."[72]
  • Hypocognition (the absence of a simple, consolidated mental framework that new information can be placed into) can hinder the application of EBM.[73]
  • Valid enthusiasm for science should not cross the line into scientism, losing critical perspective.
  •  Although clinical experience and expert opinion are insufficient by themselves, neither are they valueless, as EBM fervor that approaches scientism sometimes tends to paint them.

This last point is repetition of a very important shortcoming.

  • An informed clinician can weigh confounding variables in a clinical case and decide that following a population-based guideline to the letter feels inadequate for the situation. Thus clinical backlash against "cookbook medicine" is not always misguided, and "guidelines are not gospel."[74]
  •  Conceptual models, by having fewer variables than always-multivariate reality, face limits of predictive accuracy, just as even the best supercomputer simulations cannot predict the weather with 100% accuracy, whether because of the butterfly effect or otherwise.
  •  Thus, just as clinical judgment alone cannot give epistemological completeness, neither can RCTs and systematic reviews alone.”

The answer to the reader’s last comment and question, “I believe a carrot and stick approach may be necessary with more carrot and less stick.  Your thoughts?” is

I believe that government must learn how to evaluate quality medical care accurately, if they want to base healthcare payments on the quality of medical care. Presently, the government is far from achieving that goal.

It could also be that measuring quality medical care is not President Obama’s goal.

 The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

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Meaning and Significance Of Evidence Based Medicine

Stanley Feld M.D.,FACP, MACE

I received the following from a reader after re-publishing Medical Care Must Not Be Converted To A Commodity.

"Hello Dr. Feld,

Can I ask a question regarding voluntary Physician compliance with evidenced based care. Your thoughts 

Who sets the guidelines (and changes them) and how do we get compliance when we know it takes a LONG time for new guidelines to gain adoption?

I believe a carrot and stick approach may be necessary with more carrot and less stick.  Your thoughts?

Thanks,

These are three great questions. They demand an answer.

1. Can I ask a question regarding voluntary Physician compliance with evidenced based care? 

This question is very difficult to answer with our present state of knowledge.

There is no Level 1 evidence based data available to the answer question.

Level 1 is evidenced based data is defined as;

Level I: Evidence obtained from at least one properly designed randomized controlled trial

2. Who sets the guidelines (and changes them) and how do we get compliance when we know it takes a LONG time for new guidelines to gain adoption?

I believe most practicing physicians try to comply with clinical guidelines written by their specialty organization. Most specialty organizations publish guidelines.

The guidelines are taught in courses physicians are required take to obtain Continuing Medical Education (CME) credits required for medical re-licensing. Guidelines by specialty groups differ slightly reflecting each specialty organizations clinical emphasis, clinical experience and clinical judgment in addition to the available evidence based medicine.

It would be nice to be able to determine if each physician in the country was up to date in every single area of medicine and surgery.

I would also be nice to have accurate measurable criteria to judge physicians’ practices.

How do you evaluate physicians’ judgment and clinical experience with a computer program? You can not.

This is the reason physicians object to cookbook medicine and the commodization of medicine and surgery. Physicians have been trained to use clinical judgment. Clinical guidelines and algorithms are a guide to help physicians reach the best conclusion they can reach.

The problem with evidence-based medicine is that does not define quality medical care. It defines the quality of studies that are rigid protocol studies that do not honor clinical observations, experience or  judgment.

I have made this clear with my observations about the deficiencies in the USPSTF’s studies and conclusions about subclinical hypothyroidism, the PSA value or the study of osteoporosis in men over 70 years old and breast cancer screening to mention a few.

In this era of decreased funding money for clinical studies that are random, double blind controlled research studies is rare.

Observational data studies and clinical judgment studies are considered weak and invalid.

Who suffers?

Patients suffer as the government takes over more of the healthcare payment system. Government is making consumers dependent on government’s healthcare decisions.  Government relies on the advice of the USPSTF to determine the value of treatments. Many of the USPSTF conclusions are invalid in my opinion.

Rather than going through the explanation of the shortcomings in Evidence Based Medicine (EBM), on which the conclusions of the USPSTF is based, I quote the literature and will let my readers judge for themselves.  

Evidence-based medicine (EBM) is a form of medicine that aims to optimize decision-making by emphasizing the use of evidence from well designed and conducted research.

Please note that clinical judgment and observational studies are not valued.

a. Although all medicine based on science has some degree of empirical support, EBM goes further, classifying evidence by its epistemologic strength and requiring that only the strongest types (coming from meta-analyses, systematic reviews, and randomized controlled trials) can yield strong recommendations; weaker types (such as from case-control studies) can yield only weak recommendations.

In my opinion meta-analyses is invalid statistical trick. It combines studies that do not have the same design. Each included study has different numbers of patient and different statistical power along with statistical significance. Combining different study designs does not increase statistical significance overall.

 b. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians.[1]

EBM is one factor in improving medical care treatment. It should not be used exclusively in evaluating quality and paying for medical care.

Consumers of medical care are the ones that can evaluate the many factors that make up quality care. Unfortunately the government has no interest in the consumers of medical care. The focus is on decreasing the cost of care and not on improving the quality of care.

c. Use of the term rapidly expanded to include a previously described approach that emphasized the use of evidence in the design of guidelines and policies that apply to populations ("evidence-based practice policies").[2]

It has subsequently spread to describe an approach to decision-making that is used at virtually every level of health care yielding the broader term evidence-based practice.[3]

What is evidence-based practice?

Evidence-based practice (EBP) is an interdisciplinary approach to clinical practice that has been gaining ground following its formal introduction in 1992.

Its basic principles are that 1) all practical decisions should be made based upon research studies

2) That these research studies are to be selected and interpreted according to some specific norms characteristic for EBP.

Typically such norms disregard both theoretical and qualitative studies.

3) EBP considers quantitative studies according to a narrow set of criteria of what counts as evidence. If such a narrow set of methodological criteria are not applied, it is considered better just to speak instead of research-based practice.[1]

Students of EBM, EBP, and EBBP are starting to recognize the limitations of Evidence Based Medicine (EBM).

The methodology used by the Obama administration should be change before both healthcare and medical care are completely destroyed.

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

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Medical Care Must Not Be Converted To A Commodity

Stanley Feld M.D.,FACP,MACE

This blog post is a follow up to my last blog "Restricting Access To Care." I published this blog on May 10 2010. The Obama administration has ignored every word. As consumers and physicians might have notice the quality of medical care and the patient/physician relationships have deteriorated as I predicted because Obamacare.

Medical care is not patient centric. Healthcare reform (Obamacare) has been focused on process and not patients. This focus has distorted the effectiveness of medical care even more that it was pre Obamacare.

President Obama has increased the complexity of healthcare in an attempt to make medical care a commodity. His scheme is failing at the expense of consumers.

President Obama keeps on telling the same lie. “Obamacare is a success.” Consumers are not that stupid.

The public must start understanding what is happening now and not complain about why medical care has been destroyed later.

Once the public understands what is happening, individuals must write their congressperson and protest.

Consumers must not believe every lie thrown at them by the traditional media especially when the lie is counter to their every day experience.

I am republishing a previous blog that explains the attempt of turning medical care into a commodity.

Medical Care Must Not Be Converted To A Commodity

Stanley Feld M.D.,FACP,MACE

" President Obama is creating a new bureaucratic agency. It is called the Independent Payment Advisory Board. The Independent Payment Advisory Board will not be measuring clinical judgment or patient compliance when judging the effectiveness of treatment. Its measurement will be physician compliance with evidence based medicine. President Obama, please reexamine your premises.

I am in favor of clinical practice guidelines and evidence based medicine. However, both should be used as an educational tool for physicians and not as a punitive tool to judge payment.

The USPHTF will determine the evidence based medicine to be used. I have pointed out the deficiencies in the USPHTF in the past.

This bureaucracy is an attempt by the government to commoditize medical care. Once medical care is commoditized the cost for medical care is suppose to decrease.

Intensive control of the blood sugar for Type 2 Diabetes Mellitus can be expensive in the short run. If intensive control decreases the complications of Type 2 Diabetes Mellitus it can decrease costs in the long term.

The conclusion of the ACCORD study was intensive control was not worth the cost of medical care in the short term or long term. After the data was reexamined it turned out that the ACCORD conclusions were incorrect.

“It was not hypoglycemia from intensive control or intensive control itself that caused the increased deaths in the ACCORD study.”

Unfortunately, this information was not being reported on every TV station as the original study results were. The original study results set back universal use of intensive control of Type 2 Diabetes at least a decade.

“ It was important to say that in the intensive group it really was not the people with lower A1c who had problems, it actually was those who had the higher A1c who, despite intense efforts, we couldn't get under control."

This means patients did not comply with their responsibility to intensively control their chronic disease or their physicians did not teach them to control their blood sugar adequately.

"This reexamination gives a stronger momentum to the idea that we need to be thinking that one size doesn't fit all, we need to have different targets for different groups of people and perhaps different treatment strategies to reach those different targets as well. That's troubling both clinically and to the trialist.”

"This is something of a new idea, because previously there has been a strong impetus to having standardized guidelines for doctors and people with diabetes, but it's probably not the right thing to do.”

The reader can sense the discomfort of the academic physicians. They are realizing they cannot commoditize medical treatment. Ask any experienced practicing physician about their patients. Patients have different attitudes about their disease and treatment.

Each patient has to be related to differently. This is clinical judgment. Physicians communicating with their patients is called the physician patient relationships. Patients should be responsible for their outcomes along with physicians. This is the art of medicine. Neither patient nor physician can be treated as a commodity.

President Obama, I hope you are listening. Medical care is difficult to commoditize.

The ACCORD study originally suggested that the goal to normalize the HbA1c resulted in an increase in cardiovascular deaths. It turned out not to be true.

On the other hand an observational study was just published concluding that the lower the HbA1c the lower the complication risk.

The Atherosclerosis Risk in Communities (ARIC) study is a community-based assessment of 11,092 middle-aged adults in four US communities with normal HbA1c were followed for up to 15 years (4 visits at about 3-year intervals) for onset of new diabetes, new CVD, stroke, and all-cause mortality.”

The higher the HbA1c the higher the average blood sugar and the greater the risk for chronic complications of Type 2 Diabetes Mellitus. HbA1c is a measure of the average blood sugar over the previous three months.

Table. HbA1c Levels and Corresponding Multivariate Hazard Ratios

HbA1c Level

Multivariate-Adjusted Hazard Ratio

< 5%

0.52 (0.40-0.69)

5% to < 5.5%

1.00 (reference)

5.5% to < 6%

1.86 (1.67-2.08)

6% to < 6.5%

4.48 (3.92-5.13)

≥ 6.5%

16.47 (14.22-19.08)

HbA1c = hemoglobin A1c

“The hazard ratios for stroke were similar, but for all-cause mortality, HbA1c displayed a J-shaped association curve. All associations remained significant after adjustment for the baseline FPG.”

The study found HbA1c values predicted Cardiovascular Disease (CVD) or death, whereas fasting plasma glucose (FPG) levels were not significant after adjustment for other risk factors.

“The recent ADVANCE [Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation], ACCORD [Action to Control Cardiovascular Risk in Diabetes], and VADT [Veterans Affairs Diabetes Trial] trials left us wondering about the value of tight glycemic control in reducing CVD risk.

“One of the many shortcoming of each of these trials was that most participants had had diabetes for many years, and the designs could not account for the long-term accumulation of glycemic burden.”

The authors claim that the vascular damage from high HbA1c may have already occurred. Tight control during the trials might have had relatively little effect. This is probably not true.

There is evidence that normalizing the blood glucose can lead to regression of the vascular lesions that cause the complications of Diabetes.

The current ARIC analysis demonstrates that higher HbA1c levels, even in the normal range, increase CVD risk.

These results are not conclusive because it is an observational study as opposed to a double blind placebo controlled study. The USPHTF and President Obama’s Independent Payment Advisory Board would not give this study as much credit as the ACCORD study.

The ACCORD study was a placebo controlled double blind study. Its conclusions have more power than an observational study (ARIC). The problem is ACCORD measured the wrong endpoint. ACCORD has resulted in a great disservice to the standard of medical care of diabetes.

The results of The Atherosclerosis Risk in Communities (ARIC) study suggest that maintaining a HbA1c as near normal as possible even before the onset of diabetes may help prevent CVD.

As President Obama tries to quantify the standard of care he could be picking the wrong standard of care in order to reduce the cost of medical care. All medicine is local. Standards of care are always evolving. The standard of medical care should be determined by local medical leaders who are respected as teachers by local practitioners. It can also be enforced by local peer review with no monetary interest in the outcome.

President Obama’s effort to improve medical care at a reduced price will not succeed if it is interpreted as a punitive measure by a national bureaucracy.

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone.

May 30, 2010 "

A healthcare system that would work and be cost effective must be a consumer driven healthcare system. It must be patient centered and not stakeholder centered.

It must put consumers in a position of responsibility for their health and healthcare dollars and not in a position of dependence on the government.

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

Please have a friend subscribe

  • Thanks for leaving a comment, please keep it clean. HTML allowed is strong, code and a href.

Permalink:

Medical Care Must Not Be Converted To A Commodity

Stanley Feld M.D.,FACP,MACE

This blog post is a follow up to my last blog "Restricting Access To Care." I published this blog on May 10 2010. The Obama administration has ignored every word. As consumers and physicians might have notice the quality of medical care and the patient/physician relationships have deteriorated as I predicted because Obamacare.

Medical care is not patient centric. Healthcare reform (Obamacare) has been focused on process and not patients. This focus has distorted the effectiveness of medical care even more that it was pre Obamacare.

President Obama has increased the complexity of healthcare in an attempt to make medical care a commodity. His scheme is failing at the expense of consumers.

President Obama keeps on telling the same lie. “Obamacare is a success.” Consumers are not that stupid.

The public must start understanding what is happening now and not complain about why medical care has been destroyed later.

Once the public understands what is happening, individuals must write their congressperson and protest.

Consumers must not believe every lie thrown at them by the traditional media especially when the lie is counter to their every day experience.

I am republishing a previous blog that explains the attempt of turning medical care into a commodity.

Medical Care Must Not Be Converted To A Commodity

Stanley Feld M.D.,FACP,MACE

" President Obama is creating a new bureaucratic agency. It is called the Independent Payment Advisory Board. The Independent Payment Advisory Board will not be measuring clinical judgment or patient compliance when judging the effectiveness of treatment. Its measurement will be physician compliance with evidence based medicine. President Obama, please reexamine your premises.

I am in favor of clinical practice guidelines and evidence based medicine. However, both should be used as an educational tool for physicians and not as a punitive tool to judge payment.

The USPHTF will determine the evidence based medicine to be used. I have pointed out the deficiencies in the USPHTF in the past.

This bureaucracy is an attempt by the government to commoditize medical care. Once medical care is commoditized the cost for medical care is suppose to decrease.

Intensive control of the blood sugar for Type 2 Diabetes Mellitus can be expensive in the short run. If intensive control decreases the complications of Type 2 Diabetes Mellitus it can decrease costs in the long term.

The conclusion of the ACCORD study was intensive control was not worth the cost of medical care in the short term or long term. After the data was reexamined it turned out that the ACCORD conclusions were incorrect.

“It was not hypoglycemia from intensive control or intensive control itself that caused the increased deaths in the ACCORD study.”

Unfortunately, this information was not being reported on every TV station as the original study results were. The original study results set back universal use of intensive control of Type 2 Diabetes at least a decade.

“ It was important to say that in the intensive group it really was not the people with lower A1c who had problems, it actually was those who had the higher A1c who, despite intense efforts, we couldn't get under control."

This means patients did not comply with their responsibility to intensively control their chronic disease or their physicians did not teach them to control their blood sugar adequately.

"This reexamination gives a stronger momentum to the idea that we need to be thinking that one size doesn't fit all, we need to have different targets for different groups of people and perhaps different treatment strategies to reach those different targets as well. That's troubling both clinically and to the trialist.”

"This is something of a new idea, because previously there has been a strong impetus to having standardized guidelines for doctors and people with diabetes, but it's probably not the right thing to do.”

The reader can sense the discomfort of the academic physicians. They are realizing they cannot commoditize medical treatment. Ask any experienced practicing physician about their patients. Patients have different attitudes about their disease and treatment.

Each patient has to be related to differently. This is clinical judgment. Physicians communicating with their patients is called the physician patient relationships. Patients should be responsible for their outcomes along with physicians. This is the art of medicine. Neither patient nor physician can be treated as a commodity.

President Obama, I hope you are listening. Medical care is difficult to commoditize.

The ACCORD study originally suggested that the goal to normalize the HbA1c resulted in an increase in cardiovascular deaths. It turned out not to be true.

On the other hand an observational study was just published concluding that the lower the HbA1c the lower the complication risk.

The Atherosclerosis Risk in Communities (ARIC) study is a community-based assessment of 11,092 middle-aged adults in four US communities with normal HbA1c were followed for up to 15 years (4 visits at about 3-year intervals) for onset of new diabetes, new CVD, stroke, and all-cause mortality.”

The higher the HbA1c the higher the average blood sugar and the greater the risk for chronic complications of Type 2 Diabetes Mellitus. HbA1c is a measure of the average blood sugar over the previous three months.

Table. HbA1c Levels and Corresponding Multivariate Hazard Ratios

HbA1c Level

Multivariate-Adjusted Hazard Ratio

< 5%

0.52 (0.40-0.69)

5% to < 5.5%

1.00 (reference)

5.5% to < 6%

1.86 (1.67-2.08)

6% to < 6.5%

4.48 (3.92-5.13)

≥ 6.5%

16.47 (14.22-19.08)

HbA1c = hemoglobin A1c

“The hazard ratios for stroke were similar, but for all-cause mortality, HbA1c displayed a J-shaped association curve. All associations remained significant after adjustment for the baseline FPG.”

The study found HbA1c values predicted Cardiovascular Disease (CVD) or death, whereas fasting plasma glucose (FPG) levels were not significant after adjustment for other risk factors.

“The recent ADVANCE [Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation], ACCORD [Action to Control Cardiovascular Risk in Diabetes], and VADT [Veterans Affairs Diabetes Trial] trials left us wondering about the value of tight glycemic control in reducing CVD risk.

“One of the many shortcoming of each of these trials was that most participants had had diabetes for many years, and the designs could not account for the long-term accumulation of glycemic burden.”

The authors claim that the vascular damage from high HbA1c may have already occurred. Tight control during the trials might have had relatively little effect. This is probably not true.

There is evidence that normalizing the blood glucose can lead to regression of the vascular lesions that cause the complications of Diabetes.

The current ARIC analysis demonstrates that higher HbA1c levels, even in the normal range, increase CVD risk.

These results are not conclusive because it is an observational study as opposed to a double blind placebo controlled study. The USPHTF and President Obama’s Independent Payment Advisory Board would not give this study as much credit as the ACCORD study.

The ACCORD study was a placebo controlled double blind study. Its conclusions have more power than an observational study (ARIC). The problem is ACCORD measured the wrong endpoint. ACCORD has resulted in a great disservice to the standard of medical care of diabetes.

The results of The Atherosclerosis Risk in Communities (ARIC) study suggest that maintaining a HbA1c as near normal as possible even before the onset of diabetes may help prevent CVD.

As President Obama tries to quantify the standard of care he could be picking the wrong standard of care in order to reduce the cost of medical care. All medicine is local. Standards of care are always evolving. The standard of medical care should be determined by local medical leaders who are respected as teachers by local practitioners. It can also be enforced by local peer review with no monetary interest in the outcome.

President Obama’s effort to improve medical care at a reduced price will not succeed if it is interpreted as a punitive measure by a national bureaucracy.

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone.

May 30, 2010 "

A healthcare system that would work and be cost effective must be a consumer driven healthcare system. It must be patient centered and not stakeholder centered.

It must put consumers in a position of responsibility for their health and healthcare dollars and not in a position of dependence on the government.

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

Please have a friend subscribe

  • Thanks for leaving a comment, please keep it clean. HTML allowed is strong, code and a href.

Permalink:

Restricting Access To Care

Stanley Feld M.D.,FACP, MACE

As a retired Clinical Endocrinologist I don’t have a vested interest in generating income for myself from the healthcare system.

What I am trying to do is help consumers and healthcare policy makers understand the present healthcare system. I fear they have no interest in understanding what would work to repair the healthcare system.

I am also trying to explain to consumers that few politicians are interested in helping them. Politicians are interested in power. They are interested in making the people dependent on them.

Politicians and the central government are interested in controlling the healthcare system, the financial system, the Internet and the environment. Once politicians control these systems the people have lost their independence and freedom. Politicians will have the power they seek.

Many of our constitutional freedoms have been disappearing. American have been on the Road To Serfdom for many years.

President Obama has hastened the journey on the road to serfdom with his blatant disregard for the constitution and the bill of rights. To my chagrin he is succeeding.

President Obama is pretending to want to provide universal care. His goal is to destroy the healthcare system so that the people will beg for the central government to control the healthcare system.  There are more uninsured people now than when he became President.

Paul Krugman is one of President Obama’s henchmen. He stated in a recent article that Obamacare is costing the government less money than the administration thought it would. He therefore calls Obamacare a success.

This administration and its henchmen in the traditional media flood us with half-truths.

Obamacare might be costing the government less than they expected. The Obama administration never told Americans what they expected to spend.

The Obama administration is the most non-transparent administration in my lifetime.  Meanwhile, the Obama administration tells Americans it is the most transparent administration in history.

CGI is a Canadian company with offices in the U.S. It had the contract to develop the Obamacare website healthcare.gov. The website was a disaster. The development cost overruns were unbelievable.

CGI received the contract through an Obama crony capital award and a non-competitive bid.

CGI receive another contract to complete the backend of healthcare.gov.

The Affordable Care Act (Obamacare) is supposed to be affordable for consumers. Consumers are experiencing higher premiums and out of pocket expenses for medical services.

1. Obamacare has been under subscribed. Only 10 million people are verified premium paying subscribers. The Obama administration projected 30 million subscribers by 2015 when Obamacare was passed in 2010.

2. The deductibles are unaffordable. Obamacare is even unaffordable to those people who receive subsidies.

The subsidized people have avoided seeing physicians in a timely manner. The result is government costs are less in the short run but will be more in the long run as people get very ill.

3. The Obama administration is keeping the expenses for infrastructure and bureaucratic structure non transparent.

4. Obamacare’s rules and regulations are resulting in restricting access to care.  

5. Paul Krugman and the Obama administration spin the truth by ignoring consumer out of pocket expenses.

There has been an explosive increase in premiums and higher deductibles though the health insurance exchanges as well as private insurance.

The Obama administration has been silent about this reality.

The Affordable Care Act is not affordable. It has not increased the “quality of care.”  

Paul Krugman does not publish the real truth in his New York Times articles. Those who still read the New York Times take his words literally. They are deceiving themselves.

One of the ways the Obama administration is restricting access to care to lower its costs is through the U.S. Preventive Services Task Force’s (USPSTF) recommendations.

I have criticized the USPSTF methodology in the past for its conclusions about many clinical practices.

The task force is composed of a group of physicians that do not have clinical expertise in the medical or surgical topic they are evaluating.

The group simply reads the medical papers assigned to them to evaluate. The committee decides the efficacy of treatment on the quality of the literature they are given to evaluate.  Clinical judgment is not included in their evaluation.

A positive decision is made if the literature contains a double blind controlled study yielding positive results.  

Last month the U.S. Preventive Services Task Force (USPSTF) issued its final recommendation statement on Screening for Thyroid Dysfunction. The USPSTF studied this topic in 2004 with the same final opinion.

This time Obamacare will probably take action and restrict the evaluation on the basis of this recommendation

  In its statement, the task force said that without more data from randomized clinical trials it could not assess the balance of benefits and harms from pre-clinical thyroid disease treatment and, thus, could not recommend that asymptomatic, non-pregnant adults be screened for thyroid dysfunction.”

 The Annals of Internal Medicine (AIM), a journal of the American Medical Association published the USPSTF recommendation without expert clinical endocrinology comment or critique.

R. Mack Harrell, MD, FACP, FACE, ECNU current President of the American Association of Clinical Endocrinologists (AACE) is having the AACE Thyroid Scientific Committee submit a note to the Annals of Internal Medical addressing AACE’s concerns with the USPSTF’s paper.

AACE has studied and written many guidelines on the evaluation and treatment of thyroid disease. Its members have vast experience as practicing clinicians in the treatment of thyroid disease. Its input should be sought by the Obama administration not ignored in favor of a default decision that saves Obamacare money and puts the financial burden of care on consumers.

The following is Dr. Mack Harrell’s comment to AACE’s membership.

In my opinion Dr. Harrell’s’ comments are totally correct and should be heeded by the Obama administration.

“While agreeing with the USPSTF’s call for new, controlled thyroid screening studies, AACE issued a press release outlining its position on aggressive case finding suggesting: that this approach is an appropriate alternative to screening in patient groups where thyroid risk factors are present.

More specifically, AACE stressed that testing and treatment are indicated in those patients who are at highest risk for developing life-altering, overt thyroid disease, including:

Patients over 60, in whom symptoms of hypothyroidism are often minimal, absent or atypical

  • Newborns (continued mandatory screening for congenital hypothyroidism recommended)
  • Those with autoimmune diseases often associated with thyroid disease, such as type 1 diabetes and pernicious anemia
  • Patients with a prior history of thyroid disease or thyroid surgery, an abnormal thyroid exam, or taking drugs known to affect the thyroid
  • Patients with a family history of thyroid illness

AACE further emphasized that careful consideration should be given to thyroid testing in women who are planning pregnancy or are already pregnant given the clear-cut detrimental effects of thyroid hormone lack on fetal development in the early phases of pregnancy.

We also intend to submit to AIM a formal statement from the AACE Thyroid Scientific Committee to address concerns that the task force’s “lack of data” argument could be incorrectly interpreted as a “lack of clinical need” to find and treat thyroid disease.

For years, members of AACE and the American College of Endocrinology have worked diligently to provide up-to-date, useful clinical guidelines and recommendations regarding decision-making about thyroid function testing for physicians. We will continue to keep our members and the medical community apprised as we communicate our position regarding thyroid disease testing.

Best regards,

R. Mack Harrell, MD, FACP, FACE, ECNU

The Obama administration has made many mistakes in writing Obamacare. Most of them have not been in favor of the consumers it professed to help.

About 50% of women over the age of 60% might have subclinical hypothyroidism. Overt clinical hypothyroidism can take several years to declare itself. During the time of subclinical hypothyroidism evolves to overt hypothyroidism patients can suffer mild to moderate symptoms that would decrease their quality of life on many levels.

I believe President Obama should show compassion and responsibility toward the millions of who people would suffer from subclinical hypothyroidism. President Obama is setting up the healthcare system to restrict access to care for these people.

I do not think he should rely on a committee that does not have the expertise in the field of clinical thyroidology.  

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

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Simple, Viable Republican Alternatives To Obamacare

Stanley Feld M.D., FACP, MACE

There are many simple and viable alternatives to Obamacare which Republicans should start considering.

Republicans should seriously consider My Ideal Medical Savings Account as an alterative to Obamacare. It is logical, simple, does not require a large complicated infrastructure and aligns all the stakeholders’ incentives.

It is easy for consumers to understand.

Consumers want to have choices. The dysfunction of our healthcare system has gotten to the point where most consumers don’t have a choice. Consumers simply do not know they lost their freedom of choice and access to care until they get sick.

Consumers think they have adequate healthcare coverage until they get sick. Only 20% of the population gets sick.

The other 80% of the population refuses to think about the problem.

When they do experience illness, the dysfunction in the healthcare system makes them furious. They want to blame someone. Physicians are usually the targets of their frustration.  

Most physicians are trapped in a situation that causes them to fight for their own survival for all the reasons I have previously enumerated. This creates a more dysfunctional healthcare system.

All the stakeholders fight for their own vested interests. These vested interests have become misaligned. The vested interest of the government is to control of the system and decrease its costs.  

Costs cannot be controlled by regulations without consumer involvement.   Consumers of healthcare must understand the effectiveness of their care is dependent on their involvement in their own medical care.

Consumers’ adherence to treatment is a key component in the effectiveness of medical care.

Medical costs cannot be controlled by government price fixing.

Medical costs cannot be controlled by government restrictions to access of care. Consumers will become sicker resulting in a higher cost illness.

Consumers must be empowered to be intelligent, motivated and responsible consumers of medical care. Only then can healthcare costs be controlled.

A functional healthcare system must provide financial incentives to consumers in order for them to want to be empowered to control costs. Consumers should not be dependent on the government to control costs.

The government must repair the actuary and accounting rules of the healthcare insurance industry. Insurance reserves should not be scored as a loss to justify premium increases.

The healthcare insurance industry takes 40 cents off the top of every insurance dollar that is spent. Consumers with both private insurance and government insurance are only getting 60 cents value for every healthcare dollar spent. The healthcare industry is allowed to do some strange accounting with their required reserves.

If this accounting method were repaired, premium costs would decrease.

Effective malpractice reform would result in a significant decrease in healthcare costs. The Obama administration refuses to believe tort reform is needed.  

Many of the rules written into Obamacare, Medicare, and Medicaid are so screwy they defy common sense and penalize consumers. One glaring rule is Medicare permitting hospitals to admit Medicare patients to the hospital for observation for 48 hours.

Medicare does not pay for Observation admissions. Patients have to pay out of pocket for these admissions.

Consumers must become aware of these screwy rules and protest them. These rules have been written by the Obama administration to save the government money. These rules penalize patients the government professes to help.

Consumers are the only stakeholders that can motivate President Obama and congress to fix the significant points of waste in the healthcare system. Consumers have the power to vote.

I do not believe that President Obama has an interest in repairing the healthcare system. All of his actions signify that he wants the healthcare system to fail. After it fails people will beg the government to completely take over and have a single party payer.

Does anyone trust the government to take over our most valuable asset, our healthcare?

The government take over will also fail because dependent consumers will figure out how to game the system just as food stamp recipient have figured out how to game that inefficient system.

The goal of a sincere administration and congress is to figure out how to motivate consumers to be “PROSUMERS” (productive consumer) with an economic interest in the healthcare system.

Airlines, banks, bookstores, entertainment venues have all figured it out. Why can’t the government help consumers figure it out?

My blog entitled “My Ideal Medical Saving Account Is Democratic” presents a consumer driven healthcare formula. It gives every socioeconomic group the opportunity to be an effective “Prosumer”.

It gives all Prosumers the incentive to be responsible for their health and healthcare dollars.

Below is the blog My Ideal Medical Savings Account Is Democratic!

My Ideal Medical Savings Account Is Democratic!

Stanley Feld M.D.,FACP,MACE

A reader sent this comment; “My Ideal Medical Savings Account (MSA) “was not democratic and leads to restriction of medical care for the less fortunate.'

This comment is totally incorrect. I suspect the comment came from a person who has “an entitlements are good mentality.”

I believe that incentives are good. They lead to innovation. Innovation leads to better ideas.

Healthcare entitlement leads to ever increasing costs, stagnation, restrict freedom of choice and decrease in access to care.

The excellent example of increasing costs, decreasing choice, and decreasing access to care is Medicaid.

The fact that someone is covered by healthcare coverage does not mean they have access to medical care.

 I have written extensively about the virtues of My Ideal Medical Savings Accounts (MSAs). They are different than Health Savings Accounts (HSAs).

HSAs put money not spent in a trust for future healthcare expenses. MSAs take the money out of play for healthcare expenses. MSAs provide a trust fund for the consumer’s retirement.

MSAs provide added incentives over HSAs to obtain and maintain good health.  Obesity is a major factor in the onset of chronic diseases. Consumers must be motivated to avoid obesity to maintain good health. MSAs can provide that incentive.

The MSA’s can replace every form of health insurance at a reduced cost. It limits the risk to the healthcare insurance industry while providing consumers with choice.

This would result in competition among healthcare providers. Competition would bring down the cost of healthcare.

Some people might not like MSA’s because they are liberating. They provide consumers of healthcare with freedom of choice. They also give consumers the opportunity to be responsible for their healthcare dollars while providing them with incentives to take care of their health.

MSAs could be used for private insurance purchasers, group insurance plans, employer self- insurance plans, State Funded self-insurance plans and Medicare and Medicaid.

In each case the funding source is different. The cost of the high deductible insurance is low because the risk is low. 

If it were a $6,000 deductible MSA, the first $6,000 would be placed in a trust for the consumer. Whatever they did not spend would go into a retirement trust.  If they spent over $6,000 they would receive first dollar healthcare insurance coverage. Their trust would obviously receive no money that year.

The incentive would be for consumers to take care of their health so they do not get sick and end up in an expensive emergency room.

If a person had a chronic illness such as asthma, Diabetes Mellitus, or heart disease with a tendency to congestive heart failure and ended up in the emergency room they would use up their $6,000.

If they took care of themselves by spending $3,000 of their $6,000 trust their funding source could afford to give their trust a $1500 reward. The benefit to the funding source is it saved money by the consumer not being admitted to the hospital. The patient stayed healthy and was more productive.

President Obama does not want to try this out. He wants consumers and businesses to be dependent of the central government for everything.

MSAs would lead to consumer independence from central government control of our healthcare. MSAs would put all consumers at whatever socioeconomic level in charge of their own destiny.

The opinions expressed in the blog “Repairing The Healthcare System” is, mine and mine alone

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Republicans who really want to repair the healthcare system should take notice of these suggestions. They should stop proposing complicated alternatives to Obamacare that will not work.

Republicans should start trying to understand the real problems in the healthcare system.

The opinions expressed in the blog “Repairing The Healthcare System” is, mine and mine alone

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The Republican Alternative to Obamacare

Stanley Feld M.D. FACP MACE

House Energy and Commerce Chairman Fred Upton along with Senate Finance Chairman Orin Hatch and Senator Richard Burr have outlined what is, at least for now, the Republican alternative to Obamacare.

The Obama administration insists that the Republicans do not have a viable alternative. I doubt that anyone in the administration has read the alternatives.

President Obama’s tactic is to marginalize any opposition even if he has not reviewed it.  

The Republicans have some good ideas. However, they do not address the basic problems in our healthcare system.

The implementation of their ideas will not repair our healthcare system.

 “Republicans have now really muddied the waters with a huge take it or leave it alternative that will have plenty of its own reasons to give voters pause.”

Obamacare has so many parts. Most of Obamacare’s parts could have been predicted to fail. It is clear that congress did not understand this destiny before passage.

Obamacare was destined to fail from the start. It is on the way toward failure today. It will also destroy the entire healthcare system.

The Republican alternative is called, "The Patient Choice, Affordability, Responsibility, and Empowerment Act." 

It's key provisions include:

A Full Repeal and Replacement of Obamacare

Eliminate Individual Mandate to Buy Health Insurance or an Employer Mandate to Offer Coverage

Consumer Protections – Republicans want to retain the popular consumer protections in Obamacare including no lifetime limits, coverage for children to age 26 on their parent's plan, and guaranteed renewability of coverage.

However, they propose to decrease the costs of healthcare insurance for younger consumers but want to increase the cost of healthcare insurance for older buyers.

The Republicans would create a new set of losers (older buyers) while increasing the incentive for younger people to buy insurance.

Republicans should be providing financial incentives for consumers to be responsible for their health and their own healthcare dollars. Consumers with chronic diseases should also be responsible for the control of their chronic disease.

 A Return to Pre-Existing Condition Limits.  This is a ridiculous provision. It guarantees the biggest villain in the healthcare system (the healthcare insurance industry) its control of premiums and profitability.

Default Enrollments – Republicans would allow states to create a default enrollment system for those eligible for tax credits as a means to reduce the number who would otherwise remain uninsured.

A complex agency would be needed to administer a complicated process.

  
High Risk Pools for the Uninsured – High-risk insurance pools did not work previously because of healthcare insurance companys’ control of the premiums for the sickest people and their high risk of disease.

 Affordable Insurance Policies – This is also a pipe dream. America’s population is becoming more obese. Obesity generates more illness and higher risk. As long as the healthcare insurance industry is calculating and is in control of the actuary risk, healthcare insurance will not be affordable. The problem is how the insurance industry is allowed to do its accounting.  

The Republicans are proposing the elimination of benefit mandates and downsizing guaranteed insurability with their "continuous coverage" provision.  

This proposal is ridiculous. As long as consumers are not responsible for their health and their healthcare dollars and the healthcare insurance industry controls  price,  the healthcare system will be increasingly more expensive and dysfunctional.

Tax Credits to Buy Coverage – Tax credits are an unearned entitlement. Unearned entitlements do not work. Tax credits would be available for those in the individual health insurance market, those working for businesses with fewer than 100 employees, and those working for larger employers that do not offer coverage.

Tax Credits Only Up to 300% of Poverty – A system of tax credits leads to an agency that must be connected to another government agency, which leads to a larger government bureaucracy. In turn the bureaucracy leads to fraud and abuse

Flat Amount Tax Credits By Age – The goal of this proposal is to eliminate federal and state exchanges. Obamacare’s state and federal exchanges have not worked no matter how the administration spins the truth.

It would be easy to just give everyone a tax credit by age. A new bureaucracy would not be needed.

However, control of price and actuarial risk is still determined by the healthcare insurance industry. Consumers are not empowered. The healthcare insurance industry is empowered. Only at the time consumers are stimulated to control their health and healthcare dollars will the system work. Tax credits and price controls do not work.
 
 No Limits on the Kind of Insurance Policies That Could Be Offered – This is not a bad idea.

Capping the Tax Exclusion on Employer-Provided Health Insurance – The entire tax benefit for the employer and the individual should be equalized. Benefits should not be exclusive. Healthcare insurance premiums should be paid for with pre-tax dollars by all. The individual market should not pay for premiums with after tax dollars and the group market pay for premiums with pre-tax dollars. The present system is a hidden tax on consumers buying insurance in the individual market.
 
 
Moving Toward Defined Contribution Health Insurance – This is a stab in the dark by Republicans. It would penalize consumers and it would benefit employers. Employer want to avoid providing the same level of healthcare coverage for all their employees
 
Medical Malpractice Reform – This is a sensible reform. It is estimated that is would lower healthcare cost between $300 and $750 billion dollars a year if all costs were included.

If malpractice reform took the right form to protect consumers and physicians, the abuse in the malpractice system by lawyers and the insurance industry would be eliminated.

Both the Democrats and the Republican have protected the lawyers and the insurance industry in the past. Past behavior is a predictor of future behavior.    

Repealing the Medicaid Expansion – Medicaid should be eliminated and replaced by an all-inclusive healthcare system.

The poor should have the same insurance coverage as the rest of society. The immediate response is the nation couldn’t afford it. Yet President Obama is expanding Medicaid as access to care is being restricted. Therefore formulas that try to control costs fail because the development of severe illness is more expensive than consumers of healthcare learning how to control their disease. A consumer having healthcare insurance coverage does not make those consumers well.  

 Empower Poorer Consumers by Giving Them Mainstream Health Plans

Republicans do not offer a plan of action within this category. It sounds good but feels as if it is an empty promise. Actually it is an important factor in repairing the healthcare system. I will explain in the next blog.

The solution to the healthcare system’s dysfunction must be a simple solution.

The Republican solutions are almost as complex as Obamacare. It does not decrease governmental bureaucracy nor does it avoid the potential for fraud and abuse.

The Republican solutions promote continued control over consumers and their freedoms.

The Republican solutions do not get to the main problem in the healthcare system.

The healthcare system must be set up so consumers are motivated to have incentive to be responsible for their own health and healthcare dollars.

The alternative to Obamacare should exclude the government from making consumers dependent on the government. 

 
The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

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