Heartland Health Research Institute

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The Safety of Covid-19 Vaccines

By: David P. Lind

The Safety of Covid-19 Vaccines

The U.S. public’s views and attitudes on the available Covid-19 vaccines can vary widely, which is a consistent finding from the Kaiser Family Foundation. The differences by age, ethnicity, politics and location can be very striking. Any hesitancy toward accepting the vaccine largely boils down to trusting that the vaccines are safe. But this rather tenuous faith in the available Covid-19 vaccines is no different than historical attitudes about vaccines from yesteryear.

With almost one-third of Americans having received at least the first Covid-19 vaccine dosage, what do we really know about the safety of the vaccines?

ANSWER: The preliminary findings appear to be very encouraging, even to those who may have personal doubts.

According to the Centers for Disease Control (CDC) on March 13, there have been 529,301 deaths from Covid-19 out of 29,113,651 total known cases. That is 1 death for every 55.0 cases.

Also reported on the CDC website (March 13), “Over 92 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through March 8, 2021. During this time, the Vaccine Adverse Event Reporting System (VAERS) received 1,637 reports of death among people who received a COVID-19 vaccine.” 

The number of vaccination deaths (1,637) – out of 92 million vaccinations given – results in 1 death for every 56,200 vaccinations. 

Given this data, the risk of you dying from Covid-19 if you become infected is 1,022 times greater than the risk of you dying from being vaccinated. 

Regarding Covid-19 risks versus vaccine risks, Dr. Robert E. Oshel, former Associate Director for Research and Disputes for the National Practitioner Data Bank, said it quite well:

Only if you are virtually certain that you could never be exposed to Covid-19 and become infected would it be safer not to be vaccinated. I don’t think that (this data) is particularly disturbing.  In fact, that seems pretty safe to me in comparison to the risk from Covid-19. I’d rather take the vaccine risk instead of the risk of getting Covid-19 and its serious complications or death.  I’d also prefer taking that small personal risk over the possibility of becoming infected and passing the virus on to others and potentially causing their deaths.

The effectiveness data for the Pfizer, Moderna, and Johnson & Johnson vaccines appear to clearly outweigh their risks. Of course, if you have certain medical risks, it is always advisable to consult with your physician about your particular medical situation.

Through March 12, the number of administered vaccines in the U.S. was 101,128,005 – which includes both first and second doses. Below is the breakdown by vaccine type:

Source: Centers for Disease Control – March 13, 2021

New data from the CDC suggests that Americans have been remarkably vigilant about getting their second Covid-19 shot.

Any hesitancy that I may have had about Covid-19 vaccines are now a thing of the past.

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Reforming State Medical Boards is Essential

By: David P. Lind

Two identical medical malpractice bills (SSB 1225 and H.F 592) have been introduced in this year’s Iowa legislature that would raise the non-economic damage cap from $250K to $1 million. In return, the bill would remove language that would allow juries to determine whether to lift the $250K cap if the losses were “substantial or permanent” to the patient. Basically, the bill’s limit of $1 million would no longer allow a jury the flexibility to award higher non-economic damages in particularly egregious cases.

Why are harmed patients held to a much higher standard (with additional barriers) than other victims of harm? (Lori Nerbonne – Patient Advocate)

Quite simply, tort reform legislative measures initiated by the medical community are meant to limit the financial exposure of doctors and hospitals, regardless of the preventability and extent of the harm they cause. Physicians and hospitals are too ensconced in maintaining their comfortable status-quo by not coming to terms with the real enemy in medical malpractice war – themselves.

Two Large Contributors to Medical Malpractice

For medical providers and their insurance companies, tweaking med mal reform is a quick, silver-bullet solution. However, this ‘solution’ is encumbered with five myths that do not address the true drivers of med mal costs. There are at least two large contributors to medical malpractice NOT addressed by this latest tort reform bill:

  1. MASSIVE MED MAL CLAIMS ARE INCURRED BY JUST A FEW DOCTORS – During a 20-year period (1990-2010), only 1.73 percent of Iowa physicians were responsible for one-half of all the money paid out for medical malpractice in our state. Most of these physicians had multiple malpractice payments. Iowa’s rate is similar to the national norms.
  2. STATE MEDICAL BOARDS TAKE LITTLE ACTION ON THEIR OWN – State medical boards are largely derelict about policing the worst offenders who repeatedly cause malpractice payouts. As for Iowa, only 16 percent of Iowa doctors with high malpractice claims had reportable action by the Iowa Board of Medicine. Only 10 percent had any reportable action taken against their clinical privileges by an Iowa hospital. As a result, a meager one-sixth of the 1.73 percent of physicians have had any action taken against their licenses – and only one-tenth of them have had any action taken against their clinical privileges.

Iowa Board of Medicine

Many state medical boards are government entities that consist of politically appointed physician members, which can be an inherent conflict-of-interest when policing physicians. Historically, physicians have a poor record of policing themselves. In January, ‘CBS This Morning’ covered this national problem. The eight-member Iowa Board of Medicine, it must be noted, consists of five physicians and three public non-physician members. There are also two alternate board members, both of which are physicians.

Recent original research by Dr. Robert E. Oshel using the National Practitioner Data Bank (NPDB) Public Use Data File through March 30, 2020, found the Iowa Board of Medicine took an average of just over 15 ‘serious’ actions per year from 2017 through 2019. Consequently, the Iowa board ranks 18th of all state boards based on the number of serious actions taken per 1,000 licensees. This means that if the Iowa board were as proactive as the most active state board, it would have taken 89.6 percent more serious actions (just over 29 more serious actions each year) than it did during that period of time.

The Harris Poll about State Medical Boards

According to a 2018 national survey by The Harris Poll, only 49 percent of Americans knew that state medical boards are responsible for the licensing and regulating of physicians in the U.S. Because the public lacks knowledge about the role of state medical boards, only 31 percent of the 2,018 survey respondents correctly understood that state medical boards should be the first authorities to contact if they have a complaint about the competence or conduct of a physician. Fifty-three percent of the respondents thought other entities should be contacted first, and the remaining 16 percent were “not at all sure” whom to contact first. Fewer than a third of Americans (27 percent) know how to find out if a physician has ever received a disciplinary action against their medical license – an indication that Americans do not use the websites of state medical boards.

Twenty percent of the Harris Poll respondents reported being subjected to physician ‘misconduct.’ Respondents living in the Midwest and South were almost twice as likely to cite experiencing physician misconduct than respondents living in the Northwest. Only 33 percent of respondents indicated they filed a complaint against or reported the physician to any organization – including a state medical board.

The Solution?

The solution for malpractice costs is to reduce malpractice acts, not create more barriers for injured patients to seek compensation. (Dr. Robert E. Oshel)

The mission of each state medical board is to protect the health, safety and welfare of the public from all incompetent, unprofessional and improperly-trained physicians through the proper licensing, disciplining and regulating of physicians. Public awareness of state medical boards is absolutely critical for those boards to be successful in achieving this mission. ‘Reform’ measures should be used to help arm and enable peer reviewers and medical boards to correct and/or discipline those outliers who actually commit adverse events in the first place.

Instead of passing the latest tort reform bill, Iowa legislators should pursue approaches that ensure the Iowa Medical Board of Medicine is equipped with legal tools and funding to adequately regulate the medical profession. This can begin by reforming the recruitment of board members to ensure there is no conflict of interest. Additionally, establishing an awareness campaign to educate the public about the purpose of the Iowa Board of Medicine is paramount to enhancing its role in receiving and investigating complaints about dangerous physicians.

Protecting physicians by ignoring repeat instances of malpractice, in addition to imposing penalties that are not commensurate with offenses, will only allow this problem to persist. Med mal claims will drop drastically with appropriate punishments. Such action would send the right message to all physicians that incompetence (and bad medicine) is not acceptable in the state of Iowa. Restoring patient trust is important.

Unfortunately, the newest effort in the Iowa legislature does nothing to do this. This legislation will only satisfy those unwilling to police themselves.

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Telehealth – Will the Pandemic Reveal its Potential?

By: David P. Lind

Telehealth has been around for at least a few decades, but its’ steady growth trajectory was injected with rocket fuel a year ago when the pandemic erupted. Most every medical provider was thrust into embracing telehealth services, and for many, a rather uncomfortable, but necessary pivot to serve patients. Going forward, one key question to address will be if the outcomes of telehealth are at least as effective as in-person visits. 

Technology and Reimbursement Concerns of Telehealth

For telehealth to become deeply rooted in the long-term medical-delivery process, a few important barriers will need to be addressed. Making the telehealth technical systems easy to use – for both physicians and patients – will require additional tweaks to simplify the physician workflow process and patient acceptance. Additionally, physicians desire to have a more-intimate rapport with patients, such as reading body language, listening to breath sounds while providing an actual physical examination.

But the elephant in the room regarding the growth of telehealth is simply this: the complicated challenges of reimbursements from payers – a key component that could determine long-term adoption. State telehealth commercial payer laws vary. For Iowa, the legislature is considering a payment parity bill that would treat telehealth reimbursement no differently than in-person care (HF294).

Telehealth Outcomes – What is Known Today

Is the quality-of-care provided remotely at least comparable to in-person care? Are patients satisfied with telehealth? There are some studies, all from the pre-pandemic period, that evaluated patient outcomes between telehealth and in-person visits. Rest assured, new pandemic data on telehealth will eventually emerge to help connect the dots on satisfaction, safety and outcomes.  

For now, pre-pandemic outcome results appear to be tepidly encouraging. The federal Agency for Healthcare Research and Quality (AHRQ) provided funding to the Pacific Northwest Evidence-based Practice Center to produce two reports on telehealth. Each report provides helpful insights on how telehealth can positively impact appropriate and safe care.

STUDY #1: Telehealth: Mapping the Evidence for Patient Outcomes from Systematic Reviews (2016): This report included over 950 studies of telehealth based on data from 58 systematic reviews published between 2007 and 2015. High-level findings show that telehealth is beneficial for specific uses and patient populations. In fact, “There is a large volume of research reporting that clinical outcomes with telehealth are as good as or better than usual care and that telehealth improves intermediate outcomes and (patient) satisfaction.” Benefit evidence was concentrated in specific uses of telehealth services for: 

  • Remote, home monitoring for patients with chronic conditions, such as chronic obstructive pulmonary disease and congestive heart failure
  • Communicating and counseling patients with chronic conditions
  • Providing psychotherapy as part of behavioral health
STUDY #2: Telehealth for Acute and Chronic Care Consultations (2019):  This report includes evidence about telehealth for acute- and chronic-care consultations from research published between 1996 and May 2018. The findings from this study provides overall conclusions that are relevant to telehealth expansion during the COVID-19 pandemic. Twenty-one studies evaluated remote intensive care units (ICUs), showing lower, statistically significant inpatient and ICU mortality rates and small, nonsignificant reductions in length of stay. Only one study specifically addressed adverse events, reporting lower rates of complications with remote ICUs.

Other Resources for Telehealth Outcomes

A few other 2018 studies also provide insight on telehealth care:

  1. Impact of Telemedicine on Mortality, Length of Stay, and Cost Among Patients in Progressive Care Units: Experience From a Large Healthcare System (2018) – Finding: Telemedicine intervention decreased overall mortality and length of stay within progressive care units without substantial cost incurrences.
  2. Effect of the School-Based Telemedicine Enhanced Asthma Management Program on Asthma Morbidity (2018) – Telemedicine intervention significantly improved symptoms and reduced healthcare utilization among urban children with persistent asthma.
  3. Telemedicine in the Mangement of Type 1 Diabetes (2018) – Finding: “Specialty diabetes care delivered via telemedicine was safe and was associated with time savings, cost savings, high appointment adherence rates, and high patient satisfaction. Our findings support growing evidence that telemedicine is an effective alternative method of health care delivery.”
  4. Telemedicine and Mobile Health Technology are Effective in the Management of Digestive Diseases: A Systematic Review (2018) – Finding: “Telemedicine and mobile health technology may be effective in managing disease activity and improving quality of life in digestive diseases.”

What Can Be Learned?

Overall, these pre-pandemic reports suggest that when patients and clinicians had a choice or when telehealth addressed an access issue, benefits of telehealth occurred. Further, this research found evidence that telehealth might benefit groups of patients during the pandemic when expanding critical care, help speed emergency care decisions, and reduce exposure to infection when replacing face-to-face care. But AHRQ issued an evidence summary report in April 2019 cautioning that more rigorous research will be needed to fully comprehend the effectiveness of telehealth consultations.

The rapid expansion of telehealth during the pandemic may provide better opportunities to learn whether telehealth is an appropriate application to use in given medical situations. Measuring the most appropriate outcomes will be extremely important for researchers to assess and analyze.

Summary

Most people agree that telehealth is here to stay. Two important influencers on telehealth growth will likely include documented health outcomes and third-party reimbursement levels. Telehealth usage will not remain at the elevated levels that COVID-19 required, but it will reach a more reasonable level and then grow where it makes most sense. Applying telehealth wisely will be important to research goals coming from the pandemic experience. New research with rigorous and detailed telehealth models will be needed to help answer these questions, and the answers may very well depend on what type of care is given under various specialties of care.

To be sure, the pandemic will reveal important findings that will determine how telehealth will expand in the future.

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Exercise, Diet and Weight Control
Time-Tested Advice

By: David P. Lind

On a recent blustery January day, I decided to seek some preventive medical advice that would sharpen my understanding on how to live a healthier life during a rather static time spent at home throughout this pandemic.

I picked up a monthly periodical entirely dedicated to the wisdom of living a healthier life, and it provided some timeless gems for our lives in 2021.  I found in-depth insight about nutrition, weight control, hypertension, heart disease, emotions, chronic ‘tiredness’ and a host of other factors affecting our physical and mental well-being.

One particular article was chock-full of wisdom that was shared by the “world’s most famous heart specialist” about maintaining a healthy heart through diet, appropriate exercise and weight control.

The kicker is that this particular periodical, Wisdom Magazine, was published 60 years ago. Wisdom Magazine, by the way, ceased publication in 1964. The May 1961 publication spent a sizeable portion on just one man, Dr. Paul Dudley White, who, at the time, was considered to be one of America’s top cardiologists.  Until I opened this periodical, I was unaware of him, nor of his substantial contributions.

Below are just a few arbitrary pearls of wisdom that he shared. Although many sound rather elementary for us in today’s world, they are worth repeating:

  • We know a thousand times more about diseases than our predecessors did generations ago, but apparently infinitely less about health.
  • The greatest challenge of public health today is keeping the middle-aged physically fit.
  • America is physically unfit as a nation and heart disease is definitely on the increase.
  • I have long advocated moderate exercise as one of the best ways to keep the heart in good condition.
  • We must give first priority to research in preventive medicine.
  • In this push-button age, man is overeating and pampering himself and “the life of Riley” often leads us into the lot of early coronary disease, high blood pressure and diabetes.
  • I would like to emphasize the beneficial effect of work on body, mind and soul in any occupation in which it is possible for a cardiac patient to engage. Idleness breeds unhappiness and is actually bad for the health.
  • Overeating may play even more of a role in the destiny of the world than the under-nutrition of hundreds of millions…As a result, the problem of overeating is far broader than that of the so-called starving millions…
  • Exercise is one of the best ways to counteract nervous tension and the best antidote is physical activity when one feels tired.
  • Just how much heredity actually counts in any given case remains for future researchers to discover, but that it plays a most significant role is a certainty.
  • Our medical ancestors were obliged to exercise much more than is the custom of most inhabitants of the so-called more-civilized countries of today.
  • Activity, both physical and mental, within reason, is important for health at any age and I think it is actually helpful for longevity. Many retire long before they should.
  • It is true that those who smoke most heavily are more likely to live shorter lives and also to have trouble with their hearts.
  • I would like to put everybody on bicycles, not once in a while, but regularly as a routine. That is a good way to prevent heart disease.
  • The easiest exercise of all, requiring no equipment except shoe leather, is walking.
  • Improvement of health in middle age and old age in this country today is greatly needed and must begin with well-established habits in youth.
  • One is never too old to exercise.

 

Dr. White was born the same year as my paternal grandmother, 1886, and was President Dwight D. Eisenhower’s physician during his heart attack in 1955.

White’s accomplishments were enormous. He helped create the International Association of Cardiology and International Cardiology Foundation, in addition to serving as executive director of the National Advisory Heart Council and chief consultant to the National Heart Institute. He was one of the founders of the American Heart Association and influential in establishing the National Institutes of Health. He wrote many papers about how lifestyle affected coronary artery disease. An avid walker and bicycle rider, he reportedly inspired Lyndon B. Johnson to return to the Senate in 1955 after his heart attack. Later in 1964, President Johnson presented Dr. White with the Presidential Medal of Freedom.

In countless ways, the world has immensely evolved over the last 60 years. Yet, when it comes to Americans’ health, the challenges we face today with diet and exercise remain daunting. Unfortunately, the population health metrics have changed dramatically during this span of time. In 1960 America, 54.2 percent of adults were not overweight or obese, yet by the year 2020 (60 years later), only 31 percent met this measurement. Conversely, over 14 percent of Americans were either obese or extremely obese in 1960. Today, this number stands at 42.4 percent.

Despite the knowledge that we had in the middle of the 20th century, positive health trends remain elusive from what has been recommended. Until Americans can connect the dots to transform personal behaviors into healthier lives, it is quite evident that Dr. White’s admonishments – multiple decades ago – will continue to be largely ignored and yet stand the test of time.

We should heed the advice of our medical ancestors, who apparently knew more, or at least preached and practiced more than we, a program of positive health habits. The habit of adequate exercise, for example, is just as important, I believe, as one’s sleep, one’s work and one’s food. – Dr. Paul Dudley White

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Surprises Should Only Come in Packages, Not from Medical Bills

By: David P. Lind

Surprises come in all shapes and sizes…and in the latest coronavirus stimulus package passed and signed into law in late December, there is at least one medical-related surprise – and it’s a pleasant one.

Many goodies are included in this massive legislation, much of it related to jump-starting an economy adversely impacted by the COVID-19 pandemic. After two years of debate in Congress, one long-standing issue that has been elusive from legislative action has now become law – curbing surprise medical bills.

The End to Surprise Medical Billing

Also known as the ‘No Surprises Act’, consumers (patients) will no longer receive unexpected ‘balance bills’ when seeking ‘emergency’ care, such as air ambulance transportation, or when receiving ‘nonemergency’ care at an in-network hospital. A balance bill represents the difference between the provider’s charge and the allowed amount (negotiated between the insurance company and providers). This law will take effect in 2022.

In a survey released in early 2020, about 18 percent of emergency room visits resulted in at least one surprise bill. In the past few years, about 1-in-5 insured adults had an unexpected medical bill from an out-of-network provider.

Typical scenarios occur when patients are required to pay additional costs due to the contract between the network provider and a non-network provider who will not accept the insurer’s negotiated fee. Prior to the enactment of this new law, the non-network provider could legally bill unsuspecting patients their non-negotiated fee. When this law takes place, patients will pay only the deductibles, coinsurance and copayment amounts they would under the in-network terms of their insurance plans.

How Non-Network Providers Are Paid

Going forward, non-network providers will need to work out acceptable payments with the affected patient’s insurer. If the patient is uninsured, then all providers are considered out-of-network, and this will require the secretary of the Department of Health and Human Services to create a provider-patient resolution process for billing purposes.

Balance billing for air ambulatory transportation, a frequent and egregious practice, will not be allowed under the new law. A far more commonly-used service, ground ambulatory transportation, has not been addressed under this legislation. However, an advisory committee will be established to recommend how to solve payment for this service.

Can Patients Still be Balanced-Billed?

In nonemergency circumstances, physicians can balance-bill their patients for services, but to do so, they must obtain consent in advance of the medical procedure. As an example, a patient may want to seek care from a non-network physician, such as a surgeon. The surgeon will need to provide a cost estimate and get the patient to consent at least 72 hours before treatment. If the turnaround time is shorter than this, the patient must receive the consent information the day the appointment is made. Additionally, the estimate must be made in good faith.

Many types of physicians, however, may not be allowed to seek consent to balance-bill for their services. Among these include: anesthesiologists, radiologists, pathologists, neonatologists, assistance surgeons or laboratories.

For Providers and Insurers – ‘Devil in the Details’

With patients being held harmless, the struggle is really between how much non-network providers will be paid by insurers. Hospitals and physicians have opposed any kind of benchmark or standard to determine the amount of the bill, while payers argued for benchmarks. The legislation found a middle ground, giving insurers and providers 30 days to negotiate payment of out-of-network bills. Should this fail, an independent dispute resolution process with an arbitrator would make the ultimate decision.

Needless to say, there are other provisions within this legislation that flesh out many other details on how to settle payment disputes between providers and payers. Thankfully, this backroom process of payment details will not require undue anxieties from innocent patients.

Summary

The No Surprise Act will fundamentally fix a problem that existed for a long time. Surprises should only come in packages we receive on special occasions, such as birthdays, anniversaries, or holidays. An unwanted invoice in the mail sent by a non-network provider will hopefully be a thing of the past.

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Medical Malpractice Facts:
Less than Two Percent of Docs are Responsible for 50 Percent of Claims Paid

By: David P. Lind

At some point, perhaps as early as this coming January when the Iowa legislative session begins, the medical establishment may revisit the goal of pushing through a bill that would establish hard-capping ‘non-economic damages’ at a certain amount (e.g.$250,000).

Given this possibility, my February 17 blog post on the David P. Lind Benchmark website requires an amended update. This alteration may appear to be very slight, but it provides additional concrete evidence to oppose tort reform expansion in Iowa and in other states. This blog, “Five Myths about Expanding Tort Reform in Iowa” discusses tort expansion in more detail.

Within that blog, I referred to medical malpractice (med mal) research performed by Robert E. Oshel, Ph.D., retired Associate Director for Research and Disputes for the National Practitioner Data Bank (NPDB) at the U.S. Dept. of Health and Human Services.* Dr. Oshel was kind enough to provide me with data specific to Iowa medical malpractice claims spanning 20-years (1990-2010). Dr. Oshel found that only 1.73 percent of Iowa physicians were responsible for one-half of all the money paid out for medical malpractice in our state. Most of these physicians had multiple malpractice payments, making them outliers from the majority of physicians practicing in Iowa.

The NPDB is an electronic repository of malpractice payments and adverse actions by state licensure boards and medical staff. Established by the U.S. Congress in 1986, the NPDB has a public use data file that provides pertinent data to studies performed by researchers. If anyone knows about the data being collected by NPDB, it would be Dr. Oshel.

The problem in Iowa – and in the U.S. – is that few of these physician outliers are either ‘re-trained’ or ‘restricted’ from practicing in this same pattern of behavior. In Iowa, for example, only 16 percent of these doctors had reportable action by the Iowa Board of Medicine. According to Dr. Oshel, only 10 percent had any reportable action taken against their clinical privileges by an Iowa hospital. Because of this, a meager one-sixth of the 1.73 percent of physicians have had any action taken against their licenses – and only one-tenth of them have had any action taken against their clinical privileges.

Blog Revision – Validated Malpractice Results

My blog revision is simply this: Dr. Oshel recently had his peer-reviewed research published in the December issue of Journal of Patient Safety (subscription required). Again, his work has been peer-reviewed, an important fact that must not be lost on reporting (and trusting) this information.

His article, “The Detection, Analysis, and Significance of Physician Clustering in Medical Malpractice Lawsuit Payouts” discusses that, in the U.S., approximately 1.8 percent of physicians were responsible for half of the $83.3 billion of malpractice claims reported to the NPDB over a 25-year period (September 1, 1990 through June 30, 2015). Oshel et al reported that if the 22,511 physician outlier claims could be substantially reduced or eliminated, it could make a major difference in the nation’s total malpractice payouts.”

Although Oshel’s published article uses national data, the Iowa information that Dr. Oshel shared with me is quite similar to the published national results. Iowa, in other words, is not an outlier from his national findings. Again, a very small proportion of Iowa doctors incur the most malpractice claims.

But the findings from the Oshel study is not unique from earlier studies. In the BMJ Quality & Safety Journal in 2013, Bismark et al, found during an 11-year period, that three percent of 18,907 Australian physicians with formal adverse complaints drew 49 percent of the grievances, while one percent accounted for a quarter of the complaints. The authors wrote that the likelihood of further complaints for individual physicians was proportional to the number of previous grievances. They concluded:

It is feasible to predict which doctors are at high risk of incurring more complaints in the near future. Widespread use of this approach to identify high-risk doctors and target quality improvement efforts coupled with effective interventions, could help reduce adverse events and patient dissatisfaction in health systems.

Another study published in The New England Journal of Medicine, performed by Studdert et al, found similar results to Oshel and Bismark. Also using data from the NPDB, the Studdert group found that one percent of U.S. physicians were responsible for 32 percent of paid malpractice claims over a 10-year period. Oshel, it must be mentioned, found that a paltry one percent accounted for 25 percent of claims. Although the 10-year study periods are different, the results are remarkably similar.

Will Tort Reform Cure Malpractice Behavior and Results?

The short answer to this question is no, it won’t. But then again, tort reform is not designed to ‘cure’ malpractice behavior.

As mentioned earlier, a small number of physicians in this country continue to grossly taint med mal claims compared to the other 98 percent of practicing physicians. If state medical boards and peer reviewers are unable or unwilling to effectively act on these outliers, distrust of the medical profession ensues.

Tort reform legislative measures initiated by the medical community are meant to restrain harmed patients (and family members) from seeking financial restitution due to actions beyond their control.  Merely attempting to ‘fix’ the problem by pushing med mal tort reform is both misguided and disingenuous when attempting to remedy an egregious problem. ‘Reform’ measures should be used to help arm and enable peer reviewers and medical boards to correct and/or discipline those outliers who actually commit adverse events in the first place. Apparently introducing tort reform measures is a much easier task than finding ways to improve and/or discipline those doctors who violate the public’s trust.

One potential solution is to develop a graduated intervention by physician ‘messengers’ who speak to offending physicians, with each incident grading upward to disciplinary processes that result in restriction or termination of privileges with appropriate reporting to state regulators, if necessary. An approach similar to this is used by Vanderbilt University School of Medicine.

A few bad (or misguided) apples should not taint an otherwise good barrel. In medicine, why should this be any different?

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*This calculation was made by Dr. Oshel in 2010 for each state, but has only been repeated since then on a national level only. This independent calculation by Dr. Oshel is unpublished research that uses the NPDB Public Use File. This data was last updated using June 2019 data. According to Dr. Oshel, “the results for this almost 30-year period were very similar to what they have been for the 20-year period using the 2010 data. I would expect 30-year Iowa data also to be very similar.”

Tracking Vaccine Adverse Events

By: David P. Lind

I’m a big fan of Michael Osterholm, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Not only was this Luther College graduate born in Waukon, Iowa, but he was recently named a member of President-Elect Joe Biden’s COVID-19 Advisory Board.

Iowa boy does good!

CIDRAP, by the way, provides excellent bare essential information for Americans to learn more about COVID-19. You can find this knowledge in the CIDRAP Take.

Throughout COVID-19 in this country, Osterholm has been consistently blunt about how serious this pandemic really is to Americans. He pulls no punches, and when others fought the science side of the pandemic, he unabashedly championed it. He, along with other credible epidemiologists and physicians, are against the ‘politicization’ of the pandemic and rabidly demonstrate accepting only the facts as they’re currently known.

Because of the politicization of COVID-19, I admit to being apprehensive about receiving any approved vaccine because of the unknown side effects. Some politicians and certain social media have made it more difficult for Americans to trust that Operation Warp Speed was implemented to benefit the American public. Or, was Operation Warp Speed more about political expediency?

Having a Database for Vaccine Adverse Events

A December 1 Wall Street Journal opinion piece, “Deploying Big Data to Determine How Well Vaccines Work,” co-written by former FDA commissioners, Scott Gottlieb and Mark McClellan, discusses a national COVID registry to track information on vaccine use that will be connected with state vaccine registries. Gottlieb, I must add, is on the boards of Pfizer and Illumina, while McClellan is on the boards of Johnson and Johnson and Cigna.

Noted journalist Merrill Goozner wrote a worthy piece in a recent Modern Healthcare publication that Biden’s COVID-19 Advisory Board should seriously consider implementing. The article, “U.S. needs database closely tracking all vaccine adverse events” provides a more logical viewpoint on why I (and half of all Americans) have hesitations about taking a Food and Drug Administration (FDA)-approved vaccine for COVID-19.

Pfizer and BioNTech (and now Moderna and AstraZeneca) tout overwhelming positive results from their COVID-19 vaccine trials. Yet, Goozner wrote the following counter-argument:

“Science by news release – when there’s no published data, no peer review and no outside oversight beyond the company’s own external data-monitoring committee – is never a good idea. Pfizer’s premature announcement, even though it does look promising, is like heralding an election outcome based on day-of-voting and not waiting for the mail-in votes to be counted.”

As suggested by Goozner, corporate hype by vaccine manufacturers should not overshadow third-party scientific review of vaccine candidates. To convince skeptical Americans to get the necessary dosage of shots, the general public must know that the vaccine is both effective AND safe. Accordingly, the U.S. needs to have a much better post-approval monitoring system. But unfortunately, we don’t have one.

Goozner further writes,

“Right now, the FDA’s Vaccine Adverse Event Reporting System relies on voluntary reports. A decade ago, an Agency for Healthcare Research and Quality-funded study, which used electronic health records from Atrius Health in Massachusetts, found fewer than one percent of vaccine-related adverse-events were reported to the FDA.”

Having a national database that includes both medical claims and records that are monitored in real time by public health officials will be key to detect rare and serious adverse events from approved vaccines and drugs. If a dangerous or concerning trend develops early in the vaccination process, it can be addressed earlier rather than later.

In addition to monitoring potential side-effect risks to certain population segments, tracking which particular vaccine was used for patients and whether there was a follow-up for the second dose (if needed) is paramount to gaining and maintaining America’s trust. How long will the vaccine’s protective benefit last? Perhaps a certain vaccine is less effective in some patients, given their age, gender, race and/or health issues?  Without having a national database to trace these issues, we may be whistling ‘Dixie’ in a cold, dark alley.

As we know, trust must be tirelessly earned. Michael Osterholm, recently interviewed on the CBS This Morning show, said that he would “be the very first person to take this vaccine…”

My Final Thoughts…

As much as I admire Osterholm, I do believe that Goozner is on to something by establishing a national database to reassure a skeptical public that any approved COVID-19 vaccines are both effective and safe – not just in clinical trials but more importantly, with the entire general population. Would this convince most skeptical Americans to get vaccinated? I’m not sure. But it would serve as a good faith effort to fulfill the FDA’s pledge to have full transparency before authorizing the emergency use of the vaccine.

The recent news of vaccines are promising, but ensuring an efficient distribution and monitoring system is in place will be critical for immediate and long-term success. With that said, Osterholm and having a national database would serve as my ‘Elvis Presley,’ prompting me to stand in line for my first (and second) shots.

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Lobbying for Social Determinants of Health?

By: David P. Lind

In healthcare, there is a HUGE amount of money flowing in many directions. The law of gravity determines the flow, originating with the lobbying that is directed to those we elect to state and federal offices. In healthcare, somewhat similar to the trickle-down theory of economics, lobbying efforts grease the skids for how money eventually changes hands.

Effective lobbying, therefore, can establish who gets paid and by how much.

Open Secrets – Center for Responsive Politics

Lobbying Congress and federal agencies to influence decisions made by the government comes at a price – but it can be worth the ‘investment.’ According to OpenSecrets.org, a nonpartisan, independent and nonprofit organization that tracks money in U.S. politics, the top 13 sectors in 2020 shows that ‘Health’ is the top lobbying sector, spending over $464 million so far this year. Since 1998, this sector has dished out over $9.5 billion, edging out ‘Misc. Business’ ($9.4 billion) and Finance/Insurance/Real Estate ($9.36 billion).  ‘Health’ lobbyists represented include the American Medical Association, American Hospital Association, pharmaceuticals, and so on.

In the $3+ trillion healthcare industry, lobbying efforts can pay off handsomely. The ‘investments’ mentioned above are merely a drop in the bucket for the eventual returns that will come sometime later. Please understand, I am not suggesting that lobbying ‘investments’ are illegal, they usually are not.

Social Determinants of Health (SDOH)

According to the National Academy of Medicine, clinical care accounts for only 10-20 percent of healthy outcomes, while our behaviors, physical environment, and social and economic factors determine the other 80-90 percent – widely known as ‘social determinants of health’ (SDOH). Using the Centers for Disease Control and Prevention’s definition, social determinants of health are “conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of-life-risks and outcomes.” In short, SDOH are all external factors that affect our health outside of the hospital or doctor’s office.

To reign in ever-increasing healthcare costs and enhance better population health, why not explore new solutions ‘upstream’ to invest in our collective health and well-being? It’s about using our limited resources more wisely on key determinants of overall health that can ultimately improve health and control healthcare costs.

When comparing the U.S. to other wealthy industrialized countries, medical spending in the U.S. accounts for a greater share of gross domestic product than social services spending. Other countries spend more of their GDP upstream attempting to address the SDOH issues that directly and indirectly impact the health of their population.

Unfortunately, such investments are often viewed as ‘socialism’ or something worse in the U.S. As Dr. Donald M. Berwick published in JAMA this past summer, The Moral Determinants of Health, “…SDOH is motivated by an embrace of the moral determinants of health, including, most crucially, a strong sense of social solidarity in the U.S.” This solidarity, by the way, includes the removal of institutional racism. Until this happens, we may not have the necessary push to pursue SDOH.

Value-Based Care

Value-based care (VBC) has become a large focus for Medicare and private payers. VBC is a payment approach by which purchasers of healthcare hold the healthcare delivery system (physicians and other providers, hospitals, etc.) accountable for both the quality and cost of care. In fact, VBC programs are all about improving population health management strategies and center on how well healthcare providers can improve quality of care based on specific measures, including the reduction of hospital readmissions, using certified health information technology, and improving preventative care. VBC is the new-age approach to replacing the now-ancient fee-for-service payment arrangement in the U.S.

Healthcare providers are justifiably uneasy because they are being required to somehow ‘fix’ the social infrastructure by improving population health management. This is made more difficult when our own legislators and political system have problems agreeing whether the sky is blue or not on any given day. As mentioned earlier, a healthier population comes from non-clinical environmental determinants that influence how people live their lives. As a result of the ACA, all not-for-profit hospitals, since 2014, have been required to conduct a community health needs assessment every three years and implement a strategy to meet those needs.

What if…

What if healthcare lobbyists leveraged their efforts to meaningfully impact SDOH? Why couldn’t healthcare lobbyists on the Hill take half of their lobbying energy and financial resources and repurpose it into a lobbying campaign to address SDOH problems, such as availability of healthy food, improved education, access to housing, transportation, safe neighborhoods, etc.? If improving community health is the direction in which VBC is moving, and health providers are being financially incented to move this needle to improve population health, perhaps healthcare lobbyists SHOULD push legislators in this new direction to help move an otherwise unmovable mountain. Set a deadline to initiate SDOH programs – perhaps in the next five or seven years. Would it be possible for legislative gridlock to succumb to bipartisan support if powerful lobbyists sang from the same sheet of music?

One example of a similar approach, as reported by Modern Healthcare, comes from Louisiana-based Ochsner Health, which is pledging $100 million over the next five years to help eliminate healthcare disparities. Obviously, there is a huge need for the healthcare community to improve SDOH challenges in the communities they serve.

The potential ‘return’ for this new approach could be massive, for both the healthcare establishment and for all Americans. If healthcare providers serve as ‘repair shops’ to mend those needing care, and are ‘graded’ and subsequently paid on how well the health of the community has improved, local and national policies must be in place to make this happen.

This may sound too straightforward and, perhaps somewhat naive. But thinking ‘differently’ may prove to be worthwhile for what ails our healthcare system. Maybe Dr. Berwick’s morally guided campaign for better health is a great start.

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A Compendium of Patient Safety Concerns for 2020…and Beyond

By: David P. Lind

According to a March 2020 report by non-profit, independent organization, ECRI Institute, diagnostic errors and maternal health issues are considered to be the top two patient safety concerns for healthcare organizations. This report, however, was released prior to Covid-19 becoming the national focal point in the U.S.

ECRI’s list of the top 10 patient safety concerns was based on analysis of more than 3.2 million patient safety events recorded via the institute’s reporting program.

The list (in order) is as follows:

    1. Missed and delayed diagnosis.
    2. Maternal health across the continuum.
    3. Early recognition of behavioral health needs.
    4. Responding to and learning from device problems.
    5. Devise cleaning, disinfection and sterilization.
    6. Standardizing safety across the system.
    7. Patient matching in the Electronic Health Records.
    8. Antimicrobial stewardship.
    9. Overrides of automated dispensing cabinets – This refers to overrides to remove medications from a computerized drug storage device before pharmacists have reviewed and approved the move.
    10. Fragmentation across care settings.

11 Takeaways for the #uniteforsafecare Public Awareness Campaign

The World Health Organization designated September 17 as World Patient Safety Day to raise awareness of healthcare safety and its importance. During that virtual event, the Patient Safety Movement provided 11 takeaways on its Patient Safety Blog for the public, patients and their families to understand while seeking care:

    1. Recognize that the system is not perfect.
    2. Stay engaged in your own health care process.
    3. Recognize that your voice matters.
    4. Don’t be intimidated.
    5. Get a second opinion.
    6. Don’t be afraid to “shop around” for healthcare.
    7. Follow your gut.
    8. Double-check everything.
    9. Minority communities must be cognizant of the social disparities in patient care.
    10. Keep in mind that health workers are not to blame, the system is to blame.
    11. Remember that we’re all in this together.

The Joint Commission’s Seven Most Common Sentinel Events

Through the first half of 2020 – ending June 30 – The Joint Commission (TJC) reviewed a total of 437 sentinel events, with 85 percent being voluntarily self-reported by an accredited or certified organization. A sentinel event is a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life. That total of 437 is a very low number because it is a grossly underreported by medical organizations. In fact, TJC estimates that only two percent of all sentinel events are reported.

The most common sentinel events for the first six months of this year are as follows:

    1. Care management – 165 reported events
    2. Surgical or invasive procedures – 131
    3. Unassigned events at the time of the report – 46
    4. Suicide – 41
    5. Protection events – 38
    6. Environment events – 12
    7. Product or devise – 4

New National Action Plan for Patient Safety

To combat preventable medical harm, the Institute for Healthcare Improvement (IHI) released a National Action Plan on September 17. The report, “Safer Together: A National Action Plan to Advance Patient Safety” was arranged by 27 federal agencies, safety organizations and experts, and patient and family advocates. The plan focuses on four key areas:

    1. Culture
    2. Leadership and governance
    3. Workforce safety
    4. Learning systems
Keeping patient safety front and center is critical to force-needed changes within our healthcare environment.

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Patient Safety Week: Different Approaches Can Be Taken in Iowa

By: David P. Lind

Rightfully so, the spread of the coronavirus (COVID-19) in our country and abroad remains at the top of daily headlines. From quarantines, stock market slumps, flight cancellations and a shortage of supplies such as face masks and hand sanitizers, this is a huge concern around the world. According to the World Health Organization (WHO), COVID-19 “…is a new virus to which no one has immunity.”

At the date of this writing (March 9), about 3,900 people have died from COVID-19 (mostly in mainland China), and there are now more than 111,000 global cases, with infections in more than 70 countries and territories. Additionally, three Iowans have tested positive with the virus. The U.S. death toll is at 22 and climbing. Without question, we must remain urgently focused on this very dangerous and deadly epidemic.

But we should also be mindful that we have been in the middle of another epidemic for decades that greatly impacts each of us – preventable medical errors. According to a national report in 2016, up to 250,000 Americans die each year in our hospitals due to preventable medical errors, roughly 700 needless deaths each day. Another 2013 estimate is at over 400,000 deaths, or about 1,100 each day. The 2017 Iowa Patient Safety Study that HHRI performed revealed that one-in-five patients in Iowa experienced a medical error within the past five years – with about 60 percent occurring in Iowa hospitals.

Patient Safety Awareness Week is this week (March 8 – 14) and it recognizes the importance of patient safety in all healthcare settings. Tackling preventable medical errors to ensure patient safety is a monumental goal, requiring multi-layered ‘solutions.’ Any worthwhile approach must begin with two essential words, patient-centric.

The general public assumes that medical errors are comprehensively monitored by appropriate state-based and federal agencies. Unfortunately, this is not the case.  A January 2018 Des Moines Register editorial correctly stated, “Without concrete data on medical errors, we don’t know how many people are affected or whether any efforts are successful in reducing mistakes.”

Until employers and the general public demonstrably insist medical errors be accurately tracked and improvement shown, little will be accomplished. There are two paths for Iowa to learn more about the prevalence of medical errors and to gauge success in reducing these errors. One path is through the Iowa legislature, requiring new reporting requirements by medical providers, while the other path is through a public-private partnership that enables grass-roots initiatives to organically develop.  Both paths would require heavy lifting.

PATH 1:  LEGISLATIVE EFFORTS

The legislation process is wrought with many potholes that would hinder progress, much of which are politically-motivated with lobbying agendas that represent the provider community and their best interests. Possible approaches through state-based legislation may include:

#1: Mandate Adverse Event Reporting System
Pass legislation to mandate the reporting of adverse events (medical errors) by Iowa medical providers. According to a 2014 report by the National Academy for State Health Policy, 28 states and the District of Columbia have variations of authorized adverse event reporting systems, while the remaining 22 states do not. Iowa does not have such a reporting system.

  • Purpose:  By having a robust reporting of adverse medical events in Iowa, this critical data would allow healthcare organizations and regulatory agencies to evaluate causes, revise and create processes to reduce the risk of future errors. This information, when honestly and fully reported, can help medical organizations more clearly understand the root causes of what happened, regardless of the outcome of the error, and to identify the combination of factors that caused the error or near-miss to occur.
  • Public Desire for Reporting System:  The Iowa Patient Safety Study© found that 88.5 percent Iowans, whether they experienced a medical error or not, believe the provider community should be required to tell patients if a medical error is made during the treatment. Additionally, at least three-quarters of Iowans ‘strongly agree’ that hospitals, physicians and nursing homes should be required to report all medical errors to a state-based agency.
  • Push-Back by Provider Community:  Organizations such as the Iowa Hospital Association, Iowa Medical Society and their surrogates will argue that Iowa DOES have an adverse-event reporting system in place – a voluntary one. Perhaps true, but voluntary reporting provides little value to seriously understand the true scope of the medical error problem in Iowa. Much of what is shared with the public is grossly under-reported and misleading. This behavior of withholding critical data is more provider-centered than patient-centric. It does not help the public discern the frequency of the problem and whether improvement – if any – has been made.  Having a state-mandated reporting system in place, however, does not ensure that medical providers will comply with these reporting requirements. Largely due to insufficient regulatory enforcement provisions found within states, mandatory reporting laws often result in undercounting and underreporting of accurate and comprehensive data. Effective enforcement provisions of such a mandate is critical to success.
The Iowa Candor law, passed in 2015 and expanded in 2017, was initiated by the Iowa provider community to obtain legal protection to designated healthcare providers before committing to engage with harmed patients. Although such reforms attempt to encourage a higher-level of communication about a medical error between the provider and patient, these programs are designed to serve as an added legal protection to the provider, not necessarily to the patient. Such programs give providers the incentive to admit they committed malpractice events, but in return, the programs legally shield these providers from further sanctions or reporting. This does little to protect the general public in the future. How successful these laws are to correct adverse events from happening again remains mostly unknown.

#2. Mandate HCAHPS Survey of Iowans that Includes Medical Error Experience
Currently, participating U.S. hospitals randomly survey patients using a provider-endorsed questionnaire known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS). This standardized national survey uniformly measures and publicly reports discharged patients’ perspectives about their recent hospital stay, such as: their communication with doctors/nurses, responsiveness of hospital staff, cleanliness and quietness of the hospital environment, pain management, discharge information and overall hospital rating. However, this standard tool does not include critical questions about medical errors while hospitalized.

Iowa lawmakers could pass legislation to mandate that hospitals (along with their research partners) survey patients about medical error experiences they had during the hospitalization and require those results be made public. A logical (and efficient) approach would be to include those questions in the HCAHPS survey.

#3. Establish a Central Database in a State Agency
This effort could be separate or be part of mandating an adverse reporting system in Iowa. Patients, unfortunately, are the most underused resource when measuring the outcomes of the care they receive. Iowa and many other states do not have a centralized repository for patients to report medical errors. Pursuing the feasibility of a state-wide, incident-reporting system for patients and families can encourage patient engagement as a priority for patient safety efforts. As found in the Iowa Patient Safety Study©, patients want errors to be prevented in the future and need to know a system is in place that will work toward that end.

PATH 2:  NON-LEGISLATIVE EFFORTS

As mentioned earlier, mandating medical providers to report adverse events has serious limitations, not the least being that laws seldomly correct or modify behavior to report these events. To serve as a counter-balance to insufficient provider reporting, Iowa may consider doing one (or both) of the following that will incite public opinion to nudge provider correction:

#1. Implement an independent, statewide random-sampling survey of patients who recently received care from Iowa medical providers.
From this public-private partnership, critical insight would be obtained regarding the prevalence of medical errors that would allow for future improvements. Pursuing this process would yield critical information on medical errors in Iowa that are based on both factual and scientific processes that include the patient experience and perspective. The cost to perform this annual or bi-annual survey could be jointly borne by public and private organizations with the results made available to the public. Aggregate data results could incrementally be shared with the public, but after a few years of this research, provider-specific data would be available to the public. As Supreme Court Justice Louis Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”

#2. Survey State of Iowa Employees Only
This option is a scaled-down version of the previously mentioned state-wide survey. Learning more about the experiences of State of Iowa employees and their family members would provide additional insight on how medical errors can potentially impact healthcare costs and productivity issues for a large common employer. Based on the findings, this group could serve as the harbinger for expanding to a larger statewide program sometime later.

By using verifiable facts, Iowa can begin to assess and correct a serious long-term problem that has been largely ignored. Iowa can lead the nation on patient safety practices and desired health outcomes, both of which will help control healthcare costs and enhance productivity of its residents. For this to happen, on-going data gathering will be necessary to learn how prevalent this problem is and whether progress is being made to improve patient safety. If providers are unwilling to share the adverse events on a comprehensive basis, it only makes sense to rely on retrieving the insight and experience of patients receiving this care. This process allows for a more patient-centric approach.

The COVID-19 epidemic is now upon us, requiring a vigil readiness with coherent practices. So too, we must be vigilant with patient safety practices.

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