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President-elect Trump Part 9

Stanley Feld M.D., FACP, MACE

I am extending my discussion on the importance of malpractice reform because politicians ignore the potential costs and decreased access of care resulting from the present system.

In 2003, Texas Governor Rick Perry and the Texas legislature unenthusiastically changed tort reform laws in Texas.

I thought it was inadequate tort reform. It turned out that the meager reform has had great results.

Rick Perry and the Texas legislature ended plaintiff attorneys’ practice of venue shopping for friendly judges.

They also put a cap of $250,000 on noneconomic damages like pain and suffering.

These reforms have changed the malpractice climate in Texas. The reforms limited plaintiff’s attorneys’ profitability on frivolous liability claims.

Texans believe that because of these reforms and the lack of a state income tax, Texas has become the country’s best state for economic growth and job creation.

A Perryman group report concluded,

“Perhaps the most visible economic impact of lawsuit reforms is the benefits experienced by Texans who have better access to high-quality healthcare.”

 

“Doctors and hospitals are using their liability insurance savings to expand services and initiate innovative programs; those savings have allowed Texas hospitals to expand charity care by 24%.”

The medical malpractice business for plaintiff’’s attorneys has dried up in Texas. plaintiff’s attorneys are moving to other states.

Physicians are applying for licenses to move to Texas from other states.

“In 2001, according to the American Medical Association, Texas’ ranking in physicians per capita was a dismal 48th out of 50.”

“Beginning in 2003, physicians started returning to Texas. The Texas Medical Board reports licensing 10,878 new physicians since 2003, up from 8,391 in the prior four years.”

 “Dr. Perryman, subsequent to the issuance of his Report, informed TLR Foundation that at least 1,887 of those physicians are specifically the result of lawsuit reform.”

 The Texas Hospital Association reported a 70% reduction in the number of lawsuits filed against the state’s hospitals.

Medical liability insurance rates declined. Many doctors saw average rates drop 20% to 50%.

The American Medical Association removed Texas from its list of states experiencing a liability crisis; marking the first time it has removed any state from the list.

A survey by the Texas Medical Association also found a dramatic increase in physicians’ willingness to resume certain procedures they had stopped performing, including obstetrics, neurosurgical, radiation and oncological procedures during the Texas malpractice crisis.

Two simple changes in the tort laws made malpractice suits unprofitable for plaintiff attorneys.

Rick Perry has been so impressed with the results of his tort reforms that he wanted to extend his state’s impressive tort reform record.

Mr. Perry is proposing a British-style “loser pays” rule, which would require plaintiffs to pick up the legal costs of their targets if they lose their suits.

The Wall Street Journal showed that Ezekiel Emanuel malpractice cost estimate was wrong. It is not $25 billion year.

According to the Pacific Research Institutes estimate it is at least $242 billion dollars a year. I think the cost is closer to $750 billion dollars.

 

President-elect Trump, there are other consequences of the present malpractice liability system in the U.S. that cannot be measured in dollars.

One is alawsuits emotional wear and tear on both patients and physicians,

In order to avoid potential lawsuits physicians are avoiding high-risk patients and high-risk patient procedures. The result is a decrease in patient access to necessary care.

The details of the Massachusetts Medical Society Defensive Medicine 2008 survey is profoundly important in explaining trends in the healthcare costs due to the lack of malpractice reform.

Unfortunately, the mainstream media has published only meaningless sound bites about malpractice reform significance.

The survey’s significance has not had the impact on policy it should.

The authors state that the dollar estimates do not include the diagnostic procedures, hospital admissions, specialty referrals and consultations, or unnecessary prescriptions by physicians in specialties not included in the study.

The eight specialties surveyed represent only 46% of the physicians in the Massachusetts. The real costs to the healthcare system from the practice defensive medicine in the state of Massachusetts are much higher.

I believe the costs of defensive medicine in many other states are also much higher because in many states malpractice awards are higher. This encourages litigation.

President-elect Trump, defensive medicine is a huge burden nationally to the healthcare system. Its costs will undermine any attempt at healthcare reform. You must take medical malpractice liability reform seriously. There has to be a fundamental change in the structure of adjudication.

The survey’s findings must be studied carefully. The physicians surveyed estimated their percentages for defensive medicine testing to avoid lawsuits.

The real percentages can be studied objectively using big data. . Nonetheless the current estimates reveal unsustainable waste in our dysfunctional healthcare system.

Radiological imaging is one tool overused by physicians defensively to avoid litigation. Physicians feel they must test everything even if the probability of a positive result is insignificant.

“Plain Film X-Rays: An average of 22% of X-rays were ordered for defensive reasons.”

“CT Scans: An average of 28% of CT scans were motivated by liability concerns, with major differences among specialties.”

About 33% of scans ordered by obstetricians/ gynecologists, emergency physicians, and family practitioners were done for defensive reasons.

The total number of unnecessary CT scans needs to be calculated along with its costs in order to understand the significance of the percentage presented.

The health policy solution should not be to lower the reimbursement for CT scans. The solution is to fix the medical malpractice liability system.

MRI Studies: An average of 27% of MRIs were ordered for defensive reasons, with significant differences by specialty.

Obstetricians/ gynecologists, general surgeons, and family practitioners reported the highest rates, with the lowest rates by neurosurgeons and emergency physicians.

Ultrasound Studies: An average of 24% of Ultrasounds were ordered for defensive reasons. Orthopedic surgeons (33%) and obstetricians/gynecologists (28%) reported the highest rates, with neurosurgeons (6%) and anesthesiologists (9%) the lowest.

I believe neurosurgeons are underestimating their use of radiologic procedures in order to look good. Neurosurgery is one of the specialties with the highest malpractice rates.

Please note that obstetricians/gynecologists take no chances and order the most procedures for defensive purposes.

Laboratory Testing:

An average of 18% of laboratory tests were ordered for defensive reasons, with emergency physicians (25%) reporting the highest rates and neurosurgeons (7%) the lowest.

Specialty referrals, consultations and hospitalizations are overused the most for defensive reasons. No one wants to take a chance and send the patient home even if the indication for hospitalization is small.

Specialty Referrals and Consultations:

“An average of 28% of specialty referrals and consultations were motivated by liability concerns, with significant differences by specialty.

 Obstetricians/gynecologists reported that 40% of their referrals and consultations were done for defensive reasons, and anesthesiologists and family practitioners said that 33% of their referrals and consultations were done for the same reasons.”

Hospital Admissions:

An average of 13% of hospital admissions were motivated by liability concerns, with surgical specialties reporting lower rates than the other specialties.

The cost of defensive medicine is very high and extremely wasteful.

The repair of the dysfunctional malpractice system is simple. The system must decrease financial incentives for plaintiff’s attorneys to file frivolous lawsuits.

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

All Rights Reserved © 2006 – 2015 “Repairing The Healthcare System” Stanley Feld M.D.,FACP,MACE

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Women’s Health Initiative (WHI): The Medical Community Is Waking Up

Stanley Feld M.D. FACP, MACE

The Women’s Health Initiative’s conclusions changed how peri-menopausal and post-menopausal women are treated in the U.S.

The conclusions of the study were released to the media before the medical community had a chance to study or debate the findings.

Since the media is the message and damn the facts, it was clear that estrogen caused heart disease, breast cancer, stroke and pulmonary embolism when used in peri-menopausal and post-menopausal women.

The conclusions frightened every peri-menopausal and post menopausal woman in this country. Hormone Replacement Therapy (HRT) usage has decreased by eighty percent since the WHI was published in 2002.

Women were afraid to take HRT because they were afraid to contract these deadly diseases.

Physicians were afraid to prescribe HRT because of the fear of being sued in our litigious society if their patient contracted one of these diseases.

In the years before the WHI, 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 and weight gain and promote a general sense of well being in peri-menopausal and post-menopausal women. There was no good evidence for or against breast cancer.

One common complaint about observational studies is they are not double blind studies. One observes the outcome against a control group that does not have the same outcome.

“One common observational study is about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator.[1][2] This is in contrast with experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group.”

This NIH sponsored double blind placebo controlled study (WHI) was performed to prove with a level A (double blind placebo controlled) study to test the validity of observational data reports of the positive effects of estrogen.

The WHI reported results that concluded that estrogen had the opposite effects of previous 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.

The media is the message and the conclusion resulted in the media frenzy. The implication was the medical profession was killing women by prescribing estrogen.

Prior to the release of the study’s conclusions 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 estrogen therapy (HRT) results in a healthier life.

There are many statistical problems with the WHI study. These problems have not been discussed in the media.

Practicing physicians were confused by the WHI study’s conclusions. They were also enraged because the results were released to the public before there was peer reviewed by the entire medical community.

Patients taking estrogen were upset at their physicians for giving them estrogen.

There are many defects in the WHI study from a statistical viewpoint.

  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 in the study receiving Hormone Replacement Therapy (HRT) for the first time were at least 10 years post-menopausal. This age distribution does not represent the usual population starting HRT.

 

HRT is usually started just prior to the onset of menopause or at menopause (48 years old).

  1. The drop out rate in the placebo and HRT group was 40%. The significance of the dropout rate was not addressed. This dropout rate nullifies the validity of statistical significance of all the conclusions in the study.

 

Maximal tolerable dropout rate for statistically significance of data in a study should not be greater than 20%.

Everyone had ignored this important statistical fact.

 

  1. The unblinding of 3000 women in the study represents a departure from the protocol. It biased the findings of treatment difference.

 

  1. A hazards ratio (HR) in a statistically significant conclusion should be greater than 2.0 in order for a conclusion to be valid. The Hazard Ration should not be expressed to two decimal places.

 

A Hazards Ratio of less than two does not discriminate causality from bias and confounding of variables.

  1. A 40% drop out rate nullified the power of the study. The study was not sufficiently powered to yield statistically significant results.

 

  1. Presenting data as a nominal confidence interval is valid only when one outcome is being studied against one placebo.

 

Adjusted confidence intervals must be used when multiple outcomes are involved that represent multiple confounding variables.

 

Confidence interval must not cross 1 to be statistically significant.

 

The WHI’s statistical conclusions of the WHI study were based on using nominal confidence intervals. The nominal confidence intervals were barely significant.

The WHI nominal confidence intervals came close to touching number one (1).

All of the WHI’s published adjusted confidence intervals were non significant because they all crossed 1.

These are the defects in the WHI study’s statistical analysis that invalidates its statistical significance.

The estimated Hazard Ratios (HRs), (Nominal 95% Confidence Intervals [Nom CIs] and Adjusted 95% Confidence Intervals [Adj CIs ) in the WHI study were as follows:

 

Cardiac Heart Disease: HR 1.29, Nom CI (1.02-1.63)                Adj CI 0.85-1.97.

Conclusion should have been the WHI was statistically insignificant for causing Cardiac Disease.

 

Breast cancer: HR 1.26, Nom CI(1.00-1.59),

Adj CI 0.83-1.92.

Conclusion should have been the WHI was statistically insignificant for causing Breast Cancer.

 

Stroke: HR 1.41, Nom CI (1.07-1.85)

Adj CI 0.86-2.31.

 

Conclusion should have been the WHI was statistically insignificant for causing Stroke.

 

Pulmonary Embolism: HR 2.13, Nom CI(1.39-3.25),

Adj CI 0.99-4.56.

The WHI conclusion for estrogen causing Pulmonary Embolism might be statistically significant if statistical analysis rules were not disregarded.

The Hazard Ratio (HR) was above 2. The Nominal Confidence limit (Nom Cl) did not go below 1. However it cannot be used for this study.

The Adjusted Confidence limit which must be used for this study crossed 1 making the WHI conclusion not statistically significant.

The adjusted confidence intervals were published in the original paper.

Media blitz publicity of the WHI’s invalid conclusions created a high level of public certainty about the results of the study.

Few physicians were in a position to dispute the statistical weakness of the data. Those who were in a position to dispute the statistical significance either remained silent or were marginalized.

The media blitz’ results changed the approach to women’s health in the U.S. in 2002. Eighty percent of women taking HRT discontinued estrogen replacement therapy.

In my opinion, the results have been a great disservice to women’s health. The media publicity also has had a devastating impact on the physician patient relationship and patients’ confidence in clinical research.

Even though estrogen might cause heart disease, pulmonary embolism, stroke, and breast cancer, the Women’s Health Initiative did not prove it in a statistically significant way.

Once again the media is the message.

Freedom of the press is vital to our freedom of speech, but the media’s tendency to sensationalize issues prior to proper judgment is disruptive to seeking the truth.

The medical community is starting to pick apart the conclusions of the WHI study.

I will describe some of the new and contradicting findings next time.

Dr. Joe Goldzieher, Reproductive Endocrinologist, helped me critique the statistics in 2002.

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

All Rights Reserved © 2006 – 2015 “Repairing The Healthcare System” Stanley Feld M.D.,FACP,MACE

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More ICD-10 Codes

Stanley Feld M.D., FACP, MACE

Everything the Obama administration’s healthcare administrators do, to increase their control over the healthcare system backfires.

The Obama administration has not admitted that the new coding system (ICD-10) has not worked out as well as it should have.

The fact that CMS has to add 5,500 codes in 2017 suggests that somehow the new system is being gamed.

The increase in codes from16,000 codes (in ICD-9) to 68,000 codes (in ICD-10) is a way to force providers to more fully document their diagnosis and treatment.

It is described as a way to improve patient care. I suspect it will be used as a weapon to decrease reimbursement.

The best way to improve patient care and decrease healthcare cost is to let the patients be responsible for their health and healthcare dollars.

A way needs to be developed to measure medical out as it relates to medical costs. These outcomes must be provided to patients.

The more codes there are the more the coding system can be gamed and abused by hospitals, physicians and other providers.

At this point the government is paying many other providers. These providers can also game the system. The increase in codes can result in a further increase in costs to the healthcare system.

Never the less the Obama administration seems to spin everything that backfires on it into a positive. The people are not accepting the spin anymore.

One example of the spin is the information paper CMS published about ICM-10.

One section is entitled;

How will my practice benefit from ICD-10?

ICD-10 provides an enhanced platform for physician practice. As of October 1, 2015, the ICD-10 coding classification became the new baseline for clinical data, clinical documentation, claims processing, and public health reporting.

The statement means physicians have to provide more documentation in order for the government and the healthcare insurance industry to have more control over physicians’ practices.

From proper observation and documentation to improved clinical documentation, progress notes, operative reports, and histories, the benefits of ICD-10 begin with enhanced clinical documentation enabling physicians to better capture patient visit details and lead to better care coordination and health outcomes.

It does not enable physicians to better capture patient visit details and lead to better care coordination and health outcome.

It enables government and the healthcare insurance industry to capture patient visit details. It does not necessarily lead to better care coordination and health outcomes.

Ultimately, better data paves the way for enhanced quality and greater effectiveness of patient care and safety. The benefits of ICD-10 will impact everything from patient care to each practice’s bottom line.

Better data might not lead to enhanced quality care or lead to better care coordination and health outcome. It can lead to more paperwork and more false data.

It also could conclude that the best physicians are the best documenters. It will not tell us which physicians have the best clinical judgment.

Reasons to prepare for ICD-10 can be broken down into four categories:

Clinical

  • Informs better clinical decisions as better data is documented, collected, and evaluated
  • Provides new insights into patients and clinical care due to greater specificity, laterality, and more detailed documentation of patient diseases
  • Enables patient segmentation to improve care for higher acuity patients
  • Improves design of protocols and clinical pathways for various health conditions
  • Improves tracking of illnesses and severity
  • Improves public health reporting and helps to track and evaluate the risk of adverse public health events
  • Drives greater opportunity for research, clinical trials, and epidemiological studies.
  • A lot of this is just word salad.

Operational

  • Enhances the definition of patient conditions, providing improved matching of professional resources and care teams and increasing communications between providers
  • Affords more targeted capital investment to meet practice needs through better specificity of patient conditions
  • Supports practice transition to risk-sharing models with more precise data for patients and populations.

Professional

  • Provides clear objective data for credentialing and privileges.
  • Captures more specific and objective data to support professional Maintenance of Certification reporting across specialties.
  • Improves specificity of measures for quality and efficiency reporting
  • Aids in the prevention and detection of healthcare fraud and abuse
  • Provides more specific data to support physician advocacy of health and public health policy

This section clearly defines the intention of the expanded ICD-10. It is an attempt to define physicians’ quality of care by computer and award or penalize physicians based on a potentially faulty definition of quality care. It could lead to quality care being defined by documentation, not by clinical judgment.

Financial

  • Allows better documentation of patient complexity and level of care, supporting reimbursement for care provided
  • Provides objective data for peer comparison and utilization benchmarking
  • May reduce audit risk exposure by encouraging the use of diagnosis codes with a greater degree of specificity as supported by the clinical documentation

Physicians can interpret this category as a threat to their reimbursement and their clinical judgment.

Physicians might conclude that they should do what the government tells them to do or they will lose their livelihood.

The government’s healthcare policy wonks. They are not practicing physicians. They do not understand physicians’ potential reactions. They do not consider the unintended consequences of this policy.

Once physicians understand the goal is let the government control physicians’ medical judgment there is no telling what will happen to the quality of medical care.

Quality medical care is not a science or a social science that can be managed by computer. It is a learned process by physicians integrating scientific knowledge an art of personal relationships.

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

All Rights Reserved © 2006 – 2015 “Repairing The Healthcare System” Stanley Feld M.D.,FACP,MACE

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Social Engineering

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The Defects In Obamacare

Stanley Feld M.D., FACP, MACE

We live in an era of sound bites driving opinions rather than details driving opinions. The devil is always in the details.

The defects in Obamacare are too numerous to count. President Obama provides the traditional mass media with sounds bites leading to false conclusions.

The sound bites are misleading. Many of the sound bites are lies. One such sound bite is Obamacare is working and therefore does not need changing.

He and the Democrats keep the discussion on the sound bites level and do not dig into the real issue. President Obama even keeps the details away from congress the very people he is dependent on to pass the bill.

President Obama kept the facts and details about Obamacare away from the congress and the people. He is now doing it with the Trans-Pacific Partnership (TPP).

The Trans-Pacific Partnership (TPP) is a proposed regional regulatory and investment pact. Just as with Obamacare, President Obama expects congress to vote in favor of a pact they have not debated and have not had an opportunity to read the details in the final bill.

It is another one of those bills where the administration is telling the congress and the American people you have to pass the bill in order to see what is in it.

Americans are tired of his lack of transparency and lies. They do not trust President Obama anymore.

Congress should never make the same mistake they made with Obamacare. If they do all Americans should rally to throw all the bums out.

The devil is always in the details.

United States Senator Ron Wyden (D-OR) said,

   “Congress is being kept in the dark as to the substance of the TPP negotiations, while representatives of U.S. corporations—like Halliburton, Chevron, PHRMA, Comcast, and the Motion Picture Association of America—are being consulted and made privy to details of the agreement. […]

More than two months after receiving the proper security credentials, my staff is still barred from viewing the details of the proposals that USTR is advancing. We hear that the process by which TPP is being negotiated has been a model of transparency. I disagree with that statement.[98]

President Obama and the speaker have told us it is good pact for the country’s economy. Senator Cruz is right. “Don’t vote for something whose details you do not know.”

There are many defects in Obamacare. One major defect is that it is not affordable to consumers, the federal government or state governments. When fully implemented the cost of healthcare to the federal government will be at least 50% of our GNP not the 23% of GNP predicted. Twenty three percent is bad enough.

Federal and State taxes will have to be increased to cover all medical care entitlement costs.

President Obama keeps telling us that Obamacare is working. He says it is here to stay.

The reality is Obamacare is an unworkable and costly failure in multiple areas including the health insurance exchanges, healthcare.gov, insurance premiums and deductible costs, the development of Accountable Care Organizations, maintenance of employer insurance and more.

Americans deserve a better system than Obamacare.

It is impossible to cover all of the harmful details of every category in one blog. 

It is disingenuous for President Obama to claim, in his repeated sound bites, that there is no need to change anything in Obamacare because Obamacare is working fine.

The real cost of Obamacare to consumers (especially taxpayers), the federal and state governments and the economy have not been disclosed nor are they transparent.

The real costs start to leak out with stories about how the costs affect consumers and their lifestyle.

This usually leads to the sound bites that it will be better to have a government single party payer system.

The underlying defect is that this system leads to consumers being dependent on government and not responsible for themselves. Government changes rules on a whim. Consumers do not have options. This is a road to serfdom.

After the Affordable Care Act kicked in, a 52-year-old sales and marketing entrepreneur reported his monthly health-insurance premium to cover himself and his family grew to $848 from $513. Like others, he wasn’t happy about it. “It’s taking a lot out of pocket,” he said.”

He is one of millions of Americans who earn too much to qualify for government subsidies on policies purchased through the federal insurance exchange. He was in favor of Obamacare before he realized Obamacare’s effect on reality.

 Obamacare requires insurance companies to offer insurance policies with broad coverage and greater protection against catastrophic medical costs. It also requires coverage on illnesses and conditions such as pregnancy and birth control coverage for people who do not need this coverage.

Obamacare was supposed to save every family $2,500 a year. It costs families more than $2,500 dollars a year. It was not supposed to affect anyone making less than $250,000 per year.

It is true that many of the above a not taxes. However it is a cost burden on consumers making less than $250,000 a year.

Others, making less than $50,000 a year, receive complete or partial government subsidies. This is what is meant by redistribution of wealth. It is a significant cost burden on consumers making $50,000 to $250,000 dollars a year.

Everyone remembers President Obama promising that Obamacare will not cost families making less that $250,000 one dime.

Obamacare premiums have become unaffordable to people earning less than $50,000 per year as well.

Obamacare’s goal was to cover everyone with broad insurance coverage and greater protection against catastrophic medical costs.

Yet, only 10 million out of 330 million are covered by the exchanges. Each enrollee in the exchanges also has high deductibles. These deductibles can be as high as $6,000 a year.

Many of the insurance companies claim they will be losing money after the government’s health insurance industry subsidies disappear in 2016.

These companies will leave the Obamacare federal health exchanges reducing competition. This in turn will increase premiums further and make premiums more unaffordable.

Another detail overlooked is enrollees are poorer, sicker and older. The pool is not diluted by younger, healthier and richer. The result is more expensive insurance rates.

“ HHS was saying that it needed about 40 percent of the exchange policies to be purchased by people age 18-35 to keep the exchanges financially stable. It was 28 percent in both 2014 and 2015, according to HHS data. The CBO had projected about 85 percent of exchange enrollees to be subsidized, falling toward 80 percent as enrollment grew; instead, that number is 87 percent and actually rose slightly from 2014.”

According to a study last year by the National Bureau of Economic Research, people who bought silver and bronze plans on the federal and state health insurance exchanges saw total premiums and out-of-pocket payments rise an estimated 14% to 28% higher than pre- Obamacare premiums and out of pocket expenses.

Obamacare is not fulfilling any of President Obama’s sound-bite promises.

His claim that Obamacare is working well and does not have to change makes absolutely no sense.

If one tells a lie enough times it becomes eventually becomes the truth.

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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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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Uncertainty Leads to Ineffectiveness

Stanley Feld M.D.,FACP,MACE

The implementation of Obamacare has progressed at a slow pace because of the Obama administration’s lack of understanding of physicians’ and patients’ needs.

In order to adjust to plans and policies not working as the Obama administration visualized, the administration has had to adjust policies, plans and costs.

There is no question in my mind that medicine is primed for a new age because of the advances in science, information technology and medical technology.

In my view Obamacare is a bad law. It is inhibiting progress on these upcoming advances. President Obama is trying to control provider behavior by measuring it in microscopic detail. He is trying to shift the cost and risk of patient care to physicians and patients in order to reduce costs by decreasing risk to the healthcare insurance industry.

He is trying to commoditize patient care. Obamacare is destroying the patient/physician relationship.These relationships are vital to the therapeutic index of any treatment.

Many of the Obama administration’s policy adjustments have led to uncertainty. Uncertainty of ad-lib changes in policy inhibits progress, increases costs, and produces anxiety and inefficiency.  .

One delay that has immobilized physicians has been the constant changing of implementation dates for ICDM-10 from ICM-9. Physician offices, physician groups and hospital systems are way behind in having fully functional computer information systems.

For many, the computer systems are too expensive even with President Obama’s promise of financial supplementation. It is difficult to change coding for treatment and procedures from 18,000 codes to 88,000 codes.

The reason for this coding change is for government to evaluate the work of physicians and hospitals microscopically in order to determine how much to pay them.

The government does not trust physicians. Physicians do not trust the government. In order for any system to work effectively and efficiently there must be mutual trust. Absence of mutual trust leads to more fraud and abuse, not less   

 The uncertainty about this year’s “doctor fix” is another example of uncertainty. 

In 2003 the government set up a defective measurement system intended to reduce physician reimbursement by about 5% per year. Each year the congressional “doctor fix” relieves physicians of the decrease in reimbursement from Medicare.

The SGR formula makes no sense. Medicare has reduced physician reimbursement to physicians as physicians' expenses have increased.

President Obama promise the AMA he would SGR problem.

However, each year’s “doctor fix” is cumulative. This year physicians face a 30% decrease in reimbursement despite the fact that many reimbursement codes have decreased reimbursement yearly in addition to the looming 30% decrease in reimbursement.

The policy has led physicians and physician groups to hold off on investing in coordinated care and technology. Additionally, physicians have a dim view of their return on investment for two reasons. Physicians cannot pass the cost of these new systems on to patients or the insurance industry because of the government’s pricing policies and because the government does not pay for much of the coordinated care or education of patients with chronic disease.

As a result of this uncertainty and anxiety physicians are selling their practices to hospital systems. Many physicians are salaried. These physicians figure the hospital system can have all the aggravation.  Other physicians are paid a salary plus a bonus determined by productivity. This does not eliminate the complaint that physicians have incentive to do more testing.

Many hospital systems have taken advantage of physicians’ intellectual property and surgical skill over the years. There has been a tradition of local adversarial relationships between physicians and hospitals. The hospitals’ tactics have not been obvious to many physicians. Many hospital policies are not transparent to their hospital-based physicians.

However, when it becomes apparent, the animosity between the physicians and hospitals becomes deep seated. The passive aggressive behavior of physicians inhibits the hospital system’s growth and development.

 

The Obama administration is discovering how difficult it is to form Accountable Care Organizations (ACOs).

The defects inherent in the purpose, formation, risk and implementation of ACO’s adds to its lack of success and the constant delays in implementation.

Obamacare has increased the number of Medicaid patients. Once these patients are on Medicaid, they cannot find a doctor.

President Obama had increase Medicaid payment to Primary Care Physicians in order to encourage more physician participation in Medicaid.

Physicians were hesitant to take Medicaid patients because this increased payment was temporary. The PCPs would be stuck with many low reimbursed patients.

“Kaiser Health News noted, the increases were temporary, so doctors had little incentive to alter their practices.”

This year the temporary Medicaid reimbursement increases have expired. The Medicaid rolls have increased. The PCPs were correct.  President Obama did not fix the Medicaid doctor shortage. It has only made it worse.

The number of physicians seeing patients with Medicare coverage has also decreased because of decreases in Medicare reimbursement despite the upcoming 30% decrease in Medicare payment.

President Obama ’s recent unilateral decision to alter immigration policy and provide these immigrants with healthcare insurance will only make things worse.

The ad-lib change in healthcare policy is driving physicians crazy. Many are frightened about their professional future in practicing medicine. 

There is a pervasive bias in Obamacare that favors hospital ownership of medical practices. The call for payment reforms and the call for coordinated delivery of medical care (like Accountable Care Organizations and payment “bundles”) all turn on arrangements where a single institution owns the doctors.

Where are patients’ feelings and needs in all of this? Patients are the commodities in a lucrative business that benefits secondary stakeholders.

The healthcare system as an efficient and effective healthcare system is destined to get worse because of the underlying uncertainty created by Obamacare.

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

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The Facts

Stanley Feld M.D.,FACP,MACE

The fact that the Obama administration believes that Americans are stupid as expressed by Jonathan Gruber is an insult on its own. The fact that the Obama administration persists in treating us as if we are stupid simply compounds the insult.

In the run up to the February 15th ending of the 2015 www.healthcare.gov enrollment period and the new Republican congress’ upcoming vote to repeal Obamacare, the Obama administration is trying to convince Americans that Obamacare is working and is good for all Americans.

The public knows better by now. The middle class is feeling the economic pain Obamacare has created. They sense President Obama telling another lie.

 Recent headlines have been

Obamacare Will Cost 20% Less

Affordable Care Act will Cost 20% Less Than Initial Projections, CBO Says

Right-Wing Media Won't Tell You That The CBO's New Obamacare Cost Estimates Are Lower Than Expected

President Obama’s deception implies Obamacare is cost effective. All the CBO is saying is the numbers given to it, this time, by the Obama administration show the cost of Obamacare will be 20% lower than the CBO original estimate in 2011.

The additional new taxes for Obamacare were initiated in 2011 based on those CBO estimates.

One important reason for the 20% decrease in cost from the original estimate in 2010 is that fewer people have chosen to enroll in www.healthcare.gov in 2014.

Since fewer people enrolled there is a $51 billion of savings in federal subsidies for fewer enrollees in health insurance exchanges.

This represents a failure of Obamacare not a success as claimed by the Obama Administration.

The government estimates a total 10.7 million will enroll by February 15,2015. On February 2,2015 there were 7.53 million qualified enrollees. The original estimate in 2010 was 17.5 million. The first 2015 estimate enrollment in 2014 was reduced 3 months ago to 13 million. The enrollment figure was modified.

The taxes the middle class have been forced to pay for Obamacare were not modified.

The real numbers are totally confusing because the government documentation is very difficult to follow. CMS modifies the numbers constantly with corrections. The modifications serve to keep Americans stupid and confused.

The Obama administration is now spinning the significance of the CBO report to its political advantage.

The online Daily Mail of Britain published this online story. The headline does not exactly reflect potential consequences of the Facts.

"Obamacare program costs $50,000 in taxpayer money for every American who gets health insurance, says bombshell budget report."

  • ·       Government will spend $1.993 TRILLION over a decade and take in $643 BILLION in new taxes, penalties and fees related to Obamacare
  • ·       The $1.35 trillion net cost will result in 'between 24 million and 27 million' fewer Americans being uninsured – a $50,000 price tag per person at best
  • ·       The law will still leave 'between 29 million and 31 million' nonelderly Americans without medical insurance
  • Numbers assume Obamacare insurance exchange enrollment will double between now and 2025 "

  Buried in a 15-page section of the nonpartisan organization's new ten-year budget outlook were numbers to calculate the cost of Obamacare legislation to add patients to the insurance role. “The $1.35 trillion net cost will result in 'between 24 million and 27 million' fewer Americans being uninsured – a $50,000 price tag per person at best.”

It is impossible to judge whether these estimated figures are correct because estimates are mostly wrong.

What we do know is Obamacare is not doing well from everyone’s except President Obama’s point of view. The spin is keeping all Americans who are seeking the truth confused. Americans want a solution to the deterioration of the healthcare system.

Another reason for the reduction in Obamacare healthcare spending could come from the reduction in reimbursement to physicians.

Insurance companies have not suffered the same reimbursement insult because the government has subsidized the healthcare insurance industry and provides a guaranteed profit that is not included in the CBO estimate.

A third reason for the reduction in spending could be explained in part by the growth of consumer-driven health plans and the Great Recession.

A fourth reason for the 20% reduction could be that the insurance products on the health insurance exchanges have high deductibles. It takes a while before the patients reach their deductibles and the government starts spending money on reimbursement. Patients can also be staying away from receiving appropriate medical care because they cannot afford the deductible.

The CBO report projects that 75 percent of enrollees will receive subsidies in 2015. However, 87 percent received subsidies in 2014. This is wishful thinking on the part of those who provided the data for the CBO to evaluate to believe the subsidy percentage will decrease.  The CBO projected a further decrease in subsidy to 71% in 2025.

The health insurance exchange experience so far suggests there is adverse patient selection. It can be assumed that there will be an increase in healthcare risk and an increase subsidy percentage in the future.

CBO projects the average exchange subsidy per covered enrollee in 2015 will be $4,330 and increase to $7,710 by 2025. These costs represent a 78 percent increase in costs.

However, I do not think anyone can draw any conclusions from the CBO’s report.

I do believe that Obamacare is President Obama's  push to a single party payer healthcare system because of the structure of its market driven elements are destined to fail.

Government will then take over telling us what medical care we can or cannot have.

”We are fast approaching the stage of ultimate inversion: the stage where the government is free to do anything it pleases, while the citizens may act only by permission.” - Ayn Rand

The CBO report of a 20% reduction is spending as a result of Obamacare is meaningless. It is being used by President Obama to confuse the public for political reasons.

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

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