Heartland Health Research Institute

HHRI

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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Uwe Reinhardt Got it Right

By: David P. Lind

You might not easily recognize the name, Uwe Reinhardt. He was not an actor, politician, or an exceptional dancer displaying his moves on “Dancing with the Stars.” Nor was he a novelist who wrote fiction. However, he often did write, but he used his profound economic and healthcare knowledge to educate Americans about a persistent issue that refuses to go away in this country – unmitigated pricing in U.S. healthcare.

“Price gouging” is a term used when a seller spikes the prices of goods, services or commodities to a level much higher than is considered reasonable or fair, and is considered exploitative, potentially to an unethical extent.

Yet charging:

  • $47,600 for a $400 MRI of the lower back
  • $238 for a $15 vial of eyedrops (ofloxacin)
  • $89,000 for a $1,500 for a steroid (deflazacort) to treat children with Duchenne muscular dystrophy
  • $12,600 for a $150 emergency department visit for a similar condition
  • $382,000 for a $54,000 air ambulance ride (from Ixtapa, Mexico to Chicago)
…is considered to be “healthcare.”

The reason pricing is called “healthcare” and not “price gouging” is quite simple – it may be morally and ethically wrong, but it’s currently not illegal. The problem with healthcare price gouging is that it hurts people, especially when they are in vulnerable situations. In the U.S. system of healthcare, we live in the ‘Wild West’ of anything goes – and does it ever! Compared to other advanced countries, the U.S. has the most expensive health system in the world, with prices at least twice as high for healthcare goods, drugs and services.

In 2003, Princeton economist Uwe Reinhardt, a prolific health policy expert, and his colleagues, penned an illuminating article in the journal, Health Affairs, “It’s the Prices, Stupid.” The article disputed the insurance and medical provider arguments that higher health usage in the U.S. caused costs to be higher than they should be. Instead, the authors clarified that higher spending is due mostly to higher prices for healthcare goods and services in the U.S.

Two years after his death in 2017, Reinhardt’s wife released a book, “Priced Out – The Economic and Ethical Costs of American Health Care,” about her husband’s compilations of today’s U.S. healthcare system – why it costs so much more and delivers so much less when compared to other advanced countries.

Reinhardt himself was planning on releasing this work in a forthcoming book, but he unfortunately died before its eventual release and publication. The crux of the healthcare problem, Reinhardt wrote, “is not one of economics but of social ethics.” He was often quoted saying, “Our health system is in danger of pricing kindness out of our souls.”

Reinhardt unabashedly spoke and wrote that the U.S. health system was carefully structured to enable legislation – triggered by special interest groups – to allow the supply side of the health care sector to extract enormous sums of money from the rest of society.

By having this control, the medical establishment argued that higher prices were necessary to pay for the development of new life-changing drugs, beautiful new medical buildings, and a host of other ‘necessary’ edifices of grandeur baked into the U.S. healthcare sector. Keeping the system opaque allowed those in charge to control the narrative of higher prices.

If public winds swayed to question these outrageous prices, fingers by the medical establishment were usually pointing in the direction of patients being too unhealthy and consequently requiring more services and procedures. Another culprit on why prices are high – unmitigated governmental regulation. Additionally, “because Americans are so litigious,” defensive medicine was a convenient approach to combat “unnecessary” lawsuits, citing that “tort reform will help fix this injustice.” Unchallenged pricing behaviors come in many flavors of reasons.

Reinhardt was right. This problem persists to this day – and unfortunately, will continue for a long time to come.

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Another Study Regarding Hospital Mergers – Not Good for Patients

By: David P. Lind

This past September, I wrote an Op-Ed piece for the Des Moines Register and a blog discussing the important drawbacks of the proposed merger between Sanford Health and UnityPoint Health. In early November, this merger was abruptly called off, with the Sanford Health CEO indicating that the UnityPoint board “failed to embrace the vision of a new health system of national prominence.”

For more than three decades, many hospitals around the country have been on one huge shopping spree, buying-up their competitors – both big and small. The common rationale cited by hospital executives (and their powerful associations) are that hospitals will become better health systems, patients will benefit with better quality-of-care, and that costs will go down. In short, they pitch that this buying behavior is a win-win for everyone.

Bottom line – this behavior usually favors the merging hospitals and NOT the payers and patients. It’s quite simple: Hospitals don’t consolidate to cut their prices, they do it to gain market dominance when negotiating with insurance companies. Numerous national studies validate this fact.

New Research on Mergers Refutes Hospital Mergers

A newly-released study, “Changes in Quality of Care after Hospital Mergers and Acquisitions,” published in The New England Journal of Medicine, refutes the too-often-argued pitch that mergers will improve patient outcomes. In fact, this new report suggests four dimensions that run contrary to the hyped-claims offered up by the hospital industry:

  1. “Acquired hospitals experienced a progressive decline in patient experience measures after the ownership change.”
  2. Acquiring hospitals with a lower ‘baseline’ of patient experience performance will subsequently spread this lower performance to the newly-acquired hospitals. Additionally, there was no evidence that higher-performing acquiring hospitals will boost the patient experience ratings for the acquired hospitals.
  3. Insignificant impact on 30-day readmission or mortality rates for the acquired hospitals.
  4. Any improvement that acquired hospitals had in their clinical process measurement performance happened BEFORE the ownership change, suggesting the acquisition was not a causal reason for the improvement.
The study basically suggests that, relative to hospitals that were not acquired, acquired hospitals did not improve quality of care in the following ways:

  • Patient Experience WORSENED.
  • Patient Outcomes showed NO IMPROVEMENT.
  • Clinical Processes for improved performance are INCONCLUSIVE.
The National Institute for Health Care Management (NIHCM) provides a helpful slide show on the implications of hospital mergers that do not support the arguments made by the hospital community. Additionally, a very helpful podcast about hospital mergers, Tradeoffs, discusses the implications that mergers are actually harmful to the public, and any proposed mergers in the future should be highly scrutinized by local authorities and the general public.  Tradeoffs, by the way, is supported by the Robert Wood Johnson Foundation and the California Health Care Foundation.

Regardless of the rationale they used, the board of directors at UnityPoint should be commended on nixing the proposed merger with Sanford Health. Having a ‘new health system of national prominence’ sounds like a verse from the P.T. Barnum hymnal of marketing slogans. Without question, healthcare requires less hyperbole-sounding slogans and more patient (and payer) centric action.

If hospitals really desire to lower their prices, they will find ways to eliminate clinical redundancies and increase productivity.  This does not require the pursuit of mergers, but rather, demonstrate the willingness to embrace Economics 101 of keeping overhead affordable.

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Physician and Caregiver Burnout – Yet Another Epidemic

By: David P. Lind

My particular primary-care doctor has been my medical ‘counselor’ for about 25 years. I visit her at least annually for my routine physicals, but have frequently consulted with her about obtaining referrals to specialists outside her scope of practice. I see her because I have unquestionable trust in her abilities to put my interests above any other outside influences.

On numerous occasions, I have confided in her about my family medical history, specifically having lost two siblings to different cancers. Through her own tears, I have come to accept her as yet ‘another sister’ to me – my fifth! Her compassion for my well-being is both genuine and reassuring. Suffice it to say, I have the utmost admiration for the medical professionals who work diligently on a daily basis to care for patients.

Much of what I have written in the past, whether through blogs or op-ed pieces, is directed to help educate the general public about the problems (and potential solutions) of our healthcare system. Not only is the healthcare service delivery we seek local, it is also very personal, especially as it relates to the relationships we have with the doctors, nurses and other caregivers in our communities.

But what patients may not understand is the ‘backroom’ in which clinicians are required to perform their daily work. It is within this ‘black box’ of their work environment that their human frailty may become tested and subsequently exposed, negatively impacting their own mental well-being, and possibly undermining patient care.

Caregiver Burnout

The opioid epidemic has become a large concern of our local and national conscience. But another troublesome public health crisis persists in our society, and it greatly impacts each of us, whether we know it or not – physician and caregiver burnout.

Physician and caregiver burnout have troubling symptoms, such as depression, exhaustion, dissatisfaction and a sense of failure. Losing the passion or purpose to serve others can be a powerful setback that steals the joy of practicing a noble profession. If left unaddressed, this burnout will erode the caregivers’ mental health and adversely impact patient safety.

The nurse burnout rates are reported to be between 35 and 45 percent. The burnout rates also vary by specialty. For example, specialties with the highest rates of burnout include1:

  • Urology – 54 percent
  • Neurology – 53 percent
  • Physical medicine and rehabilitation – 52 percent
  • Internal medicine – 49 percent
  • Emergency medicine – 48 percent
In fact, doctors who report burnout are twice as likely to commit a medical error. From our 2017 Iowan’s Views on Medical Errors study, Iowans reported the top cause of medical errors was from “Doctors and nurses who are overworked, stressed and tired.”

Quite understandably, when surveyed about the causes of burnout, physicians point to a plethora of bureaucratic tasks that include too much government and private insurance interference, too little pay, too many office hours, and too much time spent in front of the computer screen using electronic health records that are more about submitting the correct procedure codes to get paid by private, Medicaid and Medicare payers. Completing administrative and insurance requirements takes precious time away from providing face-to-face care to patients – perhaps twice as much time compared to treating patients.

According to an October 23, 2019 report, “Taking Action Against Burnout: A Systems Approach to Professional Well-Being,” the National Academy of Medicine (NAM) reports that 35 to 54 percent of nurses and physicians have substantial symptoms of burnout, while medical students and residents have symptoms of burnout between 45 percent and 60 percent. A recent Mayo Clinic report confirms similar findings, suggesting that 44 to 54 percent of physicians report having ‘burnout’ symptoms. A newly-released study by Medscape reported that almost half of physicians would take a pay cut to work fewer hours, and more than a quarter of physicians would give up between $20,000 and $50,000 per year in salary.

Potential Solutions to Burnout?

There is no clear consensus on what solutions will quickly ‘fix’ this growing crisis. Physicians want or favor the simplicity of administrative requirements from key payers, more relaxed insurance regulations, more stream-lined technology that allows caregivers to spend less time on computers and more time with patients. But the devil is clearly in the details.

The above-mentioned NAM report was prepared by the Committee on Systems Approaches to Improve Patient Care by Supporting Clinician Well-Being. This committee made six recommendations to serve as guidelines to help healthcare organizations design and implement systems to mitigate the factors that contribute to burnout:

  1. Create positive work environments
  2. Create positive learning environments
  3. Reduce administrative burden
  4. Enable technology solutions
  5. Provide support to clinicians and learners
  6. Invest in research (on clinician professional well-being)
Similar to the opioid epidemic, our state and country will need to become more involved to meaningfully address this particular crisis. Physician and caregiver burnout is a public health crisis that requires urgent action by healthcare organizations, state and federal governing bodies, including regulatory authorities.

Afterall, don’t we want our own doctors to be healthy, too?

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1 2017 Mayo Clinic

Research on ‘Medical Errors’ Published in National Scientific Journal

By: David P. Lind

NOTE:  Our peer-reviewed article concerning the prevalence of medical errors experienced by Iowans was released in the summer of 2018 for a future edition of the international publication, Journal of Patient Safety (JPS).  The article summarizes the experiences and opinions of a statistically representative sample of 1,010 Iowans, and provides new insights on approaches Iowa can take to determine the extent of the problem and develop solutions to obtain safer care for patients. Because there continues to be a backlog of articles not yet printed in the quarterly JPS journal, I decided to share this article now before it’s eventual inclusion in print version.

The article, “Medical Errors in Iowa: Prevalence and Patients’ Perspectives,” was co-authored by myself and two others: David R. Andresen, PhD and Andrew Williams, MA. The article reports that medical errors, also known as preventable adverse events, are seldom voluntarily reported by healthcare providers in Iowa and the U.S.

Quantifying the magnitude of the medical error problem is an essential first-step toward solving these safety issues. The hope is that vulnerabilities in the healthcare delivery process will be exposed so that solutions can be found. However, the U.S. does not have a bona fide national strategy to assess medical errors, and, as a result, hospitals and clinicians around the country do not report medical errors accurately and consistently.

The JPS article suggests there is no single method for healthcare providers to promote full, transparent reporting of medical errors. However, the approaches described can serve as a counter-balance to lax provider reporting that includes the patient experience and perspective:

  • Implement mandatory provider reporting and appropriate compliance enforcement. From this, reported errors can help medical organizations more clearly understand exactly what happened, regardless of the outcome of the error, and identify the combination of factors that caused the error or near-miss to occur.
  • Create a central state repository for patients to report medical errors, making sure the reporting process is uncomplicated.
  • Develop an on-going, independent, random-sampling process to survey patients (and family members) who recently received care to document the prevalence and nature of medical errors. This is the most disruptive approach. From this collection process, state authorities, medical providers and the public will gain critical insight on the prevalence of medical errors to allow for improvements. When errors are not reported and discussed, providers miss crucial feedback and learning opportunities.
The survey process can originate from claims data available through Medicare, Medicaid and private insurance companies. Patient experiences with medical errors can be collected and monitored for each medical provider, who would then receive systematic feedback about these errors to facilitate improvement processes. Through this data collection, results of medical errors would eventually be publicly reported for each institutional provider (e.g. hospital, surgery center, etc.).

A vast majority of Iowans have positive experiences with the healthcare system in Iowa. However, nearly one-in-five Iowa adults (18.8 percent) report having experienced a medical error either personally or with someone close to them during the past five years. Of those, 60 percent say they were not told by the responsible healthcare provider that an error had occurred. The survey found that hospitals were the most frequent site of medical errors (59 percent), while 30 percent of errors occurred in a doctor’s office or clinic, four percent in nursing homes and seven percent at some other location.

Among many important findings, the Iowa survey found that nearly 90 percent of Iowans “strongly agree” that healthcare providers should be required to tell patients about any medical errors. Additionally, 93 percent of Iowans “somewhat agree” (30 percent) or “strongly agree” (63 percent) the public should have access to medical-error information for each hospital and doctor.

Iowans feel strongly that medical errors must not be hidden from the public and should be reported, both to the patient and to an appropriate regulatory agency. Quality of healthcare will only improve when leadership, organizational culture and patient engagement are fully aligned. When seeking healthcare, patients deserve truthful, timely and transparent information about medical errors. Additionally, insurance companies can also contribute by embracing the safety of care their members receive from the medical providers included within their networks.

Our JPS article was published ahead-of-print as an open paper that is available to the public.

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Iowa DOT and Volvo Can Teach Medical Establishment a Thing or Two about Safety

By: David P. Lind

Before I comment about the never-ending problem of patient safety in our state and country, I want to provide kudos to the Iowa Department of Transportation (Iowa DOT) and Volvo for doing a great job of keeping vehicle drivers more safe.

Iowa Department of Transportation

When you drive on Iowa highways, particularly on our interstates, you will invariably see snarky, but clever, messages on 79 electronic message signs that may force a chuckle. You can thank the Iowa DOT and the public for these creative messages. The signs are designed to grab the driver’s attention with messages that are part of the ‘Zero Fatalities’ program the DOT launched back in 2014. The DOT promotes this program through blogs and social media. Additionally, the Iowa DOT pulls together safe driving and improved trauma care through a program called TraumaHawk.

Every Monday, the DOT messages change and relate to five driving categories such as buckle up, drive sober, stay alert, pay attention and slow down. But another statistic is commonly updated – sharing the latest number of fatalities on Iowa roads since the beginning of the year. This one always has my attention. Maybe it’s just me, but I am curious to know whether or not we have fewer fatalities.

I’m impressed that not only are the fatalities counted, but they are quickly shared with the public in ‘real time.’  According to the Iowa DOT website, a ‘fatality’ is considered “crash-related” when death occurs within 30 days (720 hours) of a crash. Complex crash investigations can delay the official fatalities report, so the numbers for the current months are preliminary and can change considerably.

Relating road fatalities with preventable medical error fatalities may sound like a stretch – but it’s not. The federal government and all 50 states have made vehicle fatalities and serious injuries a major safety priority. The design and manufacture of the vehicles we purchase are a direct result of these priorities.

Volvo’s Promise

At least one manufacturer, Volvo, has made safety it’s branded message – and market differentiator. This has been a huge success for Volvo when competing against a crowded field of car manufacturers. One of the visions listed by Volvo on its website is truly an eye opener:

No one should be seriously injured or killed in a new Volvo car by 2020.

There it is. Volvo has declared a zero tolerance for manufacturing unsafe vehicles. Quite an impressive Big Hairy Audacious Goal (special thanks to authors James Collins and Jerry Porras for coining the ‘BHAG’ term).

What About the Medical Care We Receive?

Why shouldn’t we have the same amount of commitment from the medical establishment, the federal government and all 50 states on tracking and reporting unsafe medical care? Great question, but we don’t.

Twenty years ago, the Institute of Medicine’s To Err is Human report was published, sending shock waves around the country that at least 44,000 and as many as 98,000 people die in hospitals due to preventable adverse events. The authors of this report called for developing a mandatory, nationwide system for reporting adverse events causing death or serious harm. Yet two decades later, we still have no system in place on a national basis. About two dozen states require providers to report adverse events, but these events are a narrow range of “never events,” which cover only a fraction of all harm events and errors. Iowa is not one of these states.

Tracking and reporting unsafe care boils down to disagreements on how to accurately measure patient harm. Arguments evolve around defining medical errors and avoidable harm, determining whether deaths were caused by errors or other factors, and heaven forbid, the inconvenience of having to collect this data.

Additionally, there is disagreement about the effectiveness of having healthcare staff voluntarily report adverse events or use other means, such as having automated harm surveillance tools embedded in the electronic health record (EHR). According to a 2011 Health Affairs article, voluntary reporting missed 90 percent of adverse events. It’s impossible to fix safety problems if only 10 percent of errors are observed and reported. Further, surveillance tools in EHRs can be manipulated to suit preference of results.

Apparently, ‘inconvenience’ seems to outweigh any perceived benefits of providing safer care. Seeking better measurements, however, should not hold up patient safety improvement efforts. Provider resistance to public reporting of errors is a big roadblock to making preventable medical errors a necessary reality. Unlike the Iowa DOT and Volvo initiatives, we have no ‘Zero Tolerance’ goal in eliminating preventable medical adverse events in Iowa or the U.S.

A New Relevant Role for Insurance Companies

Because the medical establishment and policymakers are unlikely to move forward to proactively improve healthcare outcomes and eliminate preventable medical errors, true payers – taxpayers, employers and their employees – must take charge. They must insist that ‘middlemen’ such as insurance companies implement initiatives, as I have outlined in my Des Moines Business Record article (2018), to proactively learn more from Iowa patients about their experiences with Iowa hospital and clinic encounters.

As an example, Wellmark can play a much greater, more relevant role – similar to the Iowa DOT and Volvo – and become the insurance company committed to the safety of their members – and not just function as a transactional player that processes claims with unknown outcomes. The premiums paid by Iowa employers and their employees should already include this ‘safety’ pledge that is not being acted upon. When you think about it, insurance companies are the stewards of our hard-earned money. We depend on them to use this money wisely.

Similar to our highways in Iowa today, imagine walking into your local hospital and seeing an electronic display showing real-time results of the ‘zero-tolerance’ program that reports preventable adverse events for that hospital. Now that would be a BHAG!

The next steps we take in Iowa will define our ethical commitment to this public health crisis.

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Physician Conflict of Interest – A Violation of Patient Trust

By: David P. Lind

I have received a number of suggestions from individuals and organizations to assess and write about various healthcare issues that may warrant public attention – or dare I say, scrutiny.

One such topic is featured in this blog – physician income derived from third parties that pay doctors to influence the public – and their patients. Let’s call it what it is – physician conflict of interest.

I was recently contacted by an Iowa physician who shared his concern with me about major conflicts of interest regarding some physicians. His concern: Physician income from third parties, such as drug and medical device companies, influences the prescribing behavior to patients who are unaware of such relationships. As mentioned to me:

There are some physicians who feel that the government underpays for the value of their evaluation and management (E&M) codes, so they feel entitled to make money in other ways.

In particular, there is a specialist physician in the Des Moines area who gives lectures to the public and to other physicians touting some of the newer specialty drugs. This physician prescribes many of these newer drugs to patients…those same drugs manufactured by the sponsors of these lectures. To provide some context, the disease-modifying drugs for the affliction treated by this specialist 25 years ago cost $17K annually, and now costs over $90K each year.

According to OpenPaymentsData.CMS.gov, this local physician made between $459,000-$490,000 each of the last two years from mostly drug companies. Some of this pay, it should be noted, came from “clinical research” for drug companies, but the majority of this pay during 2017 and 2018 ($337,182 and $315,801) came from “general” payments that included giving talks as an ‘influencer’ or ‘thought leader’ expert. This doctor had 321 and 294 payment ‘transactions,’ which equates to an average of over $1,000 per transaction.

It is important to note that Iowa doctors in the specialty I am referring to, on average, earn around $266,000 annually, with income generally derived from insurers and direct patient care.  Given that, it would appear that this physician made more money from drug companies than from patient care. However, it is not likely the patients were aware of that fact and assumed they were prescribed drugs that were in their best interests, without outside incentives. This ethical problem occurs regardless of specialty.

In 2018, drug and medical device companies spent $11.3 million to court Iowa physicians in sales of products that use a physician’s intellectual property, speaking arrangements, consulting, travel and lodging. When ranking all states on the amount of payments made in 2018, Iowa ranks 34th.

A recent article from ProPublica addresses physician conflict of interest on a national basis. According to the article, there are approximately 1.1 million physicians in the U.S., and “more than 600,000” physicians receive payments in any given year from the drug and medical device industry. In fact, each year from 2014 to 2018, “drug and medical device companies spent between $2.1 billion and $2.2 billion paying doctors for speaking and consulting, as well as on meals, travel and gifts for them.”

This same article indicated that many studies have found links between doctors’ prescribing choices and the payments received from third parties. You can draw your own conclusions about whether this is ethically appropriate – especially without full disclosure to patients.

ProPublica reports that despite having the federal Open Payments law that requires companies to publicly disclose the payments being made to physicians and teaching hospitals, such reporting “has not dampened the enthusiasm of the drug and medical device industry for having doctors deliver talks and sponsored speeches or paying them to consult on products.”

This law requires CMS to “collect and display information reported by applicable manufacturers and group purchasing organizations (GPOs) about the payments and other transfers of value these organizations have made to physicians and teaching hospitals.”

To search for payments made by drug and medical device companies to a particular doctor (or teaching hospital of interest), visit OpenPaymentsData.CMS.gov. and input the particular doctor or hospital’s name.

The most important duty of any physician is to act in the best interest of the patient. It begins and ends with ethical conduct that is enshrined in the AMA Code of Medical Ethics. From this flows patient trust which can result in improved medical outcomes. We need transparency safeguards in place to assure that trust is not misplaced.

Being ethical and transparent to patients and the public about any relationship with third parties, such as drug companies, is not optional in medicine – it is essential. Posting these relationships on provider websites would be a good start. No such disclosure was publicly provided by the Des Moines physician in question. Patients should not shy from asking doctors directly about their relationship with various third parties found in the OpenPaymentsData website – monetarily and otherwise. If the doctor appears uneasy about these questions, the patient should think twice about whether that doctor is the right choice.

Whether the Iowa Board of Medicine will take action on physicians who violate ethical behaviors when accepting ‘outside’ income, is unknown. If concerned about a given physician, however, contacting the Board may be worth the effort. Public attention may possibly move the needle to warrant appropriate board ‘action.’

Ultimately, doctors’ primary responsibilities are to patients. Having clear discussions about conflicts of interest can help ensure that patients receive objective and unbiased care. Doctors must earn essential trust, one patient at a time.

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