Let’s Do Public Health Better

BY KIM BELLARD

Eric Reinhart, who describes himself as “a political anthropologist, psychoanalyst, and physician,” has had a busy month. He started with an essay in NEJM about “reconstructive justice,” then an op-ed in The New York Times on how our health care system is demoralizing the physicians who work in it, and then the two that caught my attention: companion pieces in The Nation and Stat News about reforming our public health “system” from a physician-driven one to a true community health one. 

He’s preaching to my choir. I wrote almost five years ago: “We need to stop viewing public health as a boring, not glamorous, small part of our healthcare system, but, rather, as the bedrock of it, and of our health.” 

Dr. Reinhart pulls no punches about our public health system(s), or the people who lead them:

…the rot in public health is structural: It cannot be cured by simply rotating the figureheads who preside over it. Building effective national health infrastructure will require confronting pervasive distortions of public health and remaking the leadership appointment systems that have left US public health agencies captive to partisan interests.

He notes the “gradual medicalization” of public health; every director of the CDC since 1953 has been a physician, despite the oft-cited fact that medical care only accounts for perhaps 10-20% of the factors that affect our health. “Clinical reasoning, ‘ he says, “is not only not the population-level logic of public health; it is frequently antithetical to it.”

As a result, Dr. Reinhart fears: “The marginalization of non-biomedical knowledge within public health administration and the corresponding elevation of physicians to power has had catastrophic consequences for population-level health.”  

Public health needs to think much more broadly:

The core tools of public health, then, are not just vaccines or lab tests but also policies pertaining to corporate regulation and consumer safety standards; labor protections; public jobs and housing programs; investments in community health workers, decriminalization, and decarceration; and civil rights lawsuits.

It is not, he stresses, that physicians should not be involved in public health; it is just that they shouldn’t be leading it.  “Rather than doctors perpetually running the show,” Dr. Reinhart says, “clinical and scientific experts need to acknowledge the limits of their knowledge and embrace supportive roles in a redesigned public health system that is guided by and accountable to the communities whose lives are most affected by public health policy decisions.”

E.g., “America doesn’t need a world-leading virologist in charge of responding to viral threats, for example. It needs need people prepared to work collaboratively to integrate virological insights — supplied by advisers who are world-leading virologists — with the on-the-ground realities of labor, political-economic, psychological, and cultural dynamics in order to produce effective policy.”

Public health needs to built up from the “bottom-up,” Dr, Reinhart suggests, recognizing: “It’s not about individual risk tolerance, but about government making use of population-level tools—such as infrastructural investments in clean air and water—to lower the level of risk to which individuals are exposed by living in society.” If we’re not recognizing and supporting the most vulnerable, the most at-risk, the most marginalized, then we’re not doing public health. 

He acknowledges that public health is inherently political, but urges that we don’t allow it to be partisan, a distinction that is hard to draw in our polarized times.   

Gun violence is a public health problem. Opioid addiction is a public health problem. That 34 million people are food insecure is a public health problem.  The facts that 6 million homes are severely/moderately substandard and at least a half million people are homeless are public health problems. Two million people without clean water is a public health problem; 135 million people breathing polluted air is a public health crisis. Having almost 2.5 million people incarcerated is a public health problem. Having 38 million Americans living in poverty is a public health disgrace. The fact that our reading and math proficiency are at all-time lows is a public health embarrassment.

Need I go on? 

The money we’re spending on acute medical care is well-intentioned but is driving out investments – and they are investments – in public health initiatives, broadly defined.  Where is our commitment to uniformly high quality public education?  Where’s our focus on clean water and air?  Where’s our push for more affordable housing? Where’s our universal basic income?  Where are our baby bonds? When do we celebrate teachers, community leaders, and public health workers rather than billionaires?  

We suffer from what Dr. Reinhart calls “clinicism,” addressing the immediate medical problem with a pill or a procedure while “normalizing” the social conditions that led to it. That’s great for clinicians’ incomes and the various health organizations that feed off them, but lousy for our collective health. 

I also want to call attention to an essay by Aparna Mathur, Ph.D., a visiting Fellow at FREOPP, calling for modernizing our safety net. I remember thirty years ago that humorist P.J. O’Rourke “proved” there was no poverty in America; he added up all the spending on anti-poverty programs, divided by the number of people in poverty, and the answer was higher than the poverty level. I.e., the problem isn’t that we don’t spend enough money; the problem is that we don’t spend it effectively.

We have a crazy quilt of safety net programs, at federal, state, and local levels, and for the most part they’re not coordinated. Dr. Mathur shows that almost half the people who need assistance don’t get any, about a fourth only get help from one, and less than a third get multiple benefits. By creating such a number of different programs, with different eligibility criteria, different applications, overseen by different agencies, we turn seeking aid into a full-time job. And yet politicians are calling for kicking people off SNAP and Medicaid.  

Dr. Mathur calls for a “one-stop shop” for safety net programs.  She also sees the need for direct cash support, even if for a time-limited period, to “buffer individuals need to weather the current hit to incomes and any benefits, and allows them the time to invest in job search, training, while feeling supported.” 

Now, that’s public health thinking. 

We spend enormous amounts on health care, and on safety net programs.  There are a lot of vested interests in maintaining what we’re doing.  But we’re being willfully blind if we think we’re achieving our goals.  I don’t know if the suggestions from Dr. Reinhart and Dr. Mathur have any chance in today’s polarized culture wars, but I sure applaud them for raising them.   

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

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Myocarditis update from Sweden

BY ANISH KOKA

The COVID19/vaccine myocarditis debate continues in large part because our public health institutions are grossly mischaracterizing the risks and benefits of vaccines to young people.

A snapshot of what the establishment says as it relates to the particular area of concern: college vaccine mandates:

Dr. Arthur Reingold, an epidemiology professor at UC-Berkeley, notes that UC also requires immunizations for measles and chickenpox, and people still are dying from COVID at rates that exceed those for influenza. As of Feb. 1, there were more than 400 COVID deaths a day across the U.S.

“The argument in favor of mandatory vaccination for COVID is no different than the argument for mandatory vaccination for flu, measles and meningitis,” Reingold said. “For a 20-year-old college student, how likely are they to die? The risk is very low. But it’s not zero. The vaccines are safe, so the argument of continuing to mandate vaccination fits very well with the argument for the other vaccines we continue to require.”

Safety is a relative term that needs to be constantly updated when you’re talking about administering a therapeutic to “not-yet-sick” individuals. We do not vaccinate against smallpox anymore because the absence of circulating smallpox (thanks to the smallpox vaccine campaign) makes the risks of the smallpoxt vaccine too great to be administered to the public.

We can argue endlessly about what exactly the risk of COVID19 was in the Spring of 2020, or 2021, but there should be little argument in 2023 that the risks of COVID pneumonia striking down a young healthy individual is now extremely low.

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The other argument made by public health authorities is that myocarditis, the major adverse event linked to the mrna vaccines (Moderna worse than Pfizer), and Novovax actually happens more commonly with a COVID infection. I have made the case repeatedly since the Fall of 2020 that sars-cov2 (the virus that causes COVID), like the coronavirus family it comes from, has no specific proclivity for the heart, and that the published papers describing COVID19 myocarditis come from highly motivated cardiac imagers finding random bright spots on cardiac MRI devoid of clinical context and epidemiologists striking fools gold in research based on diagnostically sloppy electronic health record billing codes.

More evidence this past week that vaccine myocarditis is very much a real entity while COVID19 myocarditis is mostly a fabrication of academic researchers comes from Scandinavian countries.

A record request from a random Swedish twitter account reveals this impressive chart about myocarditis trends.

Notice that there is no spike in myocarditis diagnoses until the second half of 2021. Sweden, notably took a light approach to mitigation measures in 2020. They kept schools open, and they suffered large losses of life in care homes (as did every country) as evidence of a virus that was circulating widely through the population. And yet, there is no uptick in myocarditis cases in 2020.

This discrepancy isn’t a result of unawareness of COVID related heart issues as some have proposed because in 2020 the hysteria that surrounded COVID and the heart in 2020 was at a fever pitch. Viral videos from China of people suddenly collapsing, and the very bad German cardiac MRI paper I referenced earlier meant that everyone was looking for a tsunami of COVID heart disease. It just never materialized in the real world.

This data that was known to Swedish authorities in 2021, but not publicized to my knowledge, may have been why the Moderna vaccine with 3x the dose of mrna than Pfizer was banned for anyone < 30 years of age in the Fall of 2021 in Sweden.

The other dataset from last week comes from an epidemiological study that sought to understand the differences in prognosis between COVID19 myocarditis and vaccine myocarditis. The epidemiologists involved clearly were unaware about the issues related to the validity of the diagnosis of COVID19 myocarditis compared to vaccine myocarditis, and to top it off, were unable to specify simple things like what the severity or type of the numerically tiny primary outcome events (heart failure) they did find. As a study of prognosis of COVID vs. vaccine myocarditis, it’s a flimsy paper that is of zero clinical value. What is interesting about the study, despite the study authors admonishments not to look, is the number of vaccine associated myocarditis cases picked up during the study period1.

There were almost 5 times as many vaccine myocarditis cases as there were “COVID19 myocarditis” cases in the time window in Scandinavia that was studied. The study authors caution against making a comparison about rates of vaccine vs. covid myocarditis using these numbers because no attempt to present any denominators for covid infections or people vaccinated is given, but given the multiple other rigorous datasets that have shown spikes in vaccine myocarditis cases after the vaccine and not COVID, it’s hard not to notice that over a common number of years studied, there are a lot more vaccine myocarditis cases being diagnosed.

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And so we have a tale of two countries.

One that observed a spike in a novel serious adverse event primarily in young healthy males in the Fall of 2021, and chose to restrict the mrna vaccine that caused the most myocarditis to anyone < 30 years of age, and the other country that in February of 2023 still thinks heart problems after COVID 19 is five times more likely than vaccine myocarditis and recommends all COVID vaccines to everyone over 6 months of age.

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If no one was paying attention to what the CDC said it wouldn’t really matter, but apparently epidemiologists and others with a weak handle on reality are still mandating vaccines for college kids.

It is well beyond time for these mandates to end, and well beyond time to strip the powers of the innumerate public health hypochondriacs that are running things. There’s at least a semblance of a debate to have about what powers competent public health authorities should have over society, but there can be little argument that inmates should not be running the asylum.

Anish Koka is a Cardiologist. Follow him on twitter @anish_koka

I have to make the obligatory post-script here that I oversaw the administration of hundreds of mrna vaccines starting in March of 2021 in my cardiology clinic. The vaccine efficacy data for the original data was from thousands of patients and I certainly felt given the devastation wreaked on many of my patients in 2020 that the vaccines were the best chance of avoiding morbidity and mortality. The process to get the vaccines from the city department of health was a somewhat arduous 3 month process, and once the vaccines were on hand, there were daily reporting requirements that I dutifully performed for the many months we were administering vaccines. To accommodate the rush of patients, employees, volunteers, and conscripted children worked multiple weekends to administer the vaccines. So I’m especially disgusted by medical colleagues who label any concerns registered about vaccine adverse events as “anti-vaxx”. Registering concern over a vaccine adverse event does not make doctors or patients “anti-vaxx”. It makes them pro-vaxx!

Footnote:

  1. Recall that vaccine myocarditis cases are straightforward, usually previously healthy young men complaining of chest pain who have evidence of cardiac muscle cell necrosis and supporting cardiac imaging, while COVID myocarditis cases are almost always older, very ill hospitalized patients with pre-existing (sometimes undiagnosed) cardiac disease who have myocardial injury related to the stress of the primary diagnosis. The other COVID19 related myocarditis is not acute myocarditis, but an autoimmune condition that usually occurs months after recovery from COVID called MIS-C myocarditis. Important to note this entity has a lot of overlapping features with an autoimmune diagnosis called Kawasaki’s, and is now so rare that the CDC no longer tracks it.

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A COVID-19 vaccine exemption letter

BY ANISH KOKA

I recently saw a young man who came to see me because his place of future employment, a large health system was requiring him to complete the 1º series of his COVID-19 vaccination. He was concerned because he had chest pain after his first mRNA vaccine and was uncomfortable with the risks of a second mRNA dose. He attempted to get a Johnson and Johnson vaccine and was told by pharmacists he was not allowed to mix and match this particular vaccine as he had already received an mRNA dose. With no other option, he came to ask me whether I thought a vaccine exemption was reasonable in his case. He already had a family medicine physician sign an exemption that had been denied by his future employer’s vaccine exemption committee. The young man works on the “back end” of the health system remotely from home and he has no patient contact. The entire process has caused him to lose his health insurance from his former employer, and he was now paying out of pocket for an expensive COBRA health insurance plan. What follows is my letter to the vaccine exemption review committee regarding his case. (Published with permission, only the relevant names have been changed/redacted)

Dear Vaccine Exemption Review Committee,

I am writing this letter on behalf of John Smith DOB: xx/xx/xx in regard to a mandate from xxxx Health that Mr. Smith receive a second dose of an mRNA vaccine to complete his primary COVID-19 vaccine series.

Mr. Smith has asked me to render an opinion specifically related to his cardiac risk of receiving a second dose of an mRNA vaccine. I am a board-certified cardiologist in Philadelphia, Pennsylvania, and have been in active clinical practice for 13 years.

After reviewing the details of his case, I have grave concerns about compelling him to receive a second dose of an mRNA vaccine and would like to outline the reasons for my conclusion in this letter. I am going to specifically discuss his risk of an important, now well-recognized, adverse event: vaccine myocarditis.

What follows is some important background information about vaccine myocarditis that has been gleaned over the last 2 years before I discuss the particulars of Mr. Smith’s case.

It is relevant to note here that as a physician active clinically in both the inpatient and outpatient arenas, I am an eyewitness to the severe toll COVID-19 took on my patients in the Spring or 2020. I was impressed enough with the initial mRNA vaccine data to acquire the vaccine available from the Philadelphia Department of Health (Moderna) and ran multiple vaccine clinics in order to vaccinate my mostly high-risk patients.

What follows is data produced since the vaccine rollout that is relevant to Mr. Smith’s case.

The mRNA vaccines cause myocarditis

The risks of the novel mRNA vaccine were first clarified in April 2021 by Israeli researchers who first identified a causal link between the mRNA vaccines and myocarditis and also noted the higher incidence of myocarditis after the “second dose in young males.”

The highest incidence of vaccine myocarditis is in young men after the second dose

A number of subsequent studies that have attempted to quantify the risk of myocarditis are of variable quality largely because a number of studies used pooled risk estimates across the entire population, ignoring the observation that vaccine myocarditis has its highest incidence in young males. Studies that examine the incidence of myocarditis by age, sex, dose and manufacturer provide the most granularity with regard to risk estimation. A systematic review of vaccine myocarditis papers clearly demonstrates the highest incidence of vaccine myocarditis in young males after dose 2, and also highlights the uselessness of papers that do not stratify incidence of myocarditis by age, sex and dose of vaccine.

Vaccine myocarditis is higher risk than COVID myocarditis in young men

comprehensive study from England clearly demonstrated vaccine myocarditis to be more common than COVID19 myocarditis in age < 40 despite the fact this study greatly overestimates COVID19 myocarditis rates because it underestimates the total number of COVID19 infections.

Recent studies bring into question the diagnosis of COVID19 myocarditis

A recent cardiac imaging study suggest myocarditis is not the major mechanism of cardiac injury after a COVID-19 infection.

An accompanying editorial notes “Data from COVID-Heart provide reassuring evidence that myocarditis, once predicted to be an emerging public health crisis attributable to COVID-19, is relatively uncommon even among hospitalized patients and is less virulent than predicted during the early days of the pandemic. It is likely that elevated cardiac troponin concentrations during COVID-19 in many patients do not reflect significant new myocardial injury and fibrosis, but rather cardiac troponin release from vulnerable hearts with pre-existing scar in the setting of severe illness”

Data obtained by a record request from Sweden clearly demonstrate elevated rates of myocarditis in the time period after initiation of the COVID mass vaccination campaign, with no appreciable increase in the rate of myocarditis during widespread COVID in the year prior.

This spike in myocarditis diagnoses seen only after initiation of the vaccination campaign is corroborated by rigorous studies

6. requiring corroboration of a myocarditis diagnosis with the appropriate clinical context and cardiac imaging.

Recovery from a COVID infection confers strong, durable protection against future COVID infections

systematic review and meta-analysis of prior infection with COVID suggests protection against re-infection “was very high and remained high even after 40 weeks.” The authors of this paper go on to suggest that “the immunity conferred by past infection should be weighed alongside protection from vaccination when assessing future disease burden from COVID-19”.

Vaccine myocarditis can be serious and life threatening.

The vast majority of cases of vaccine myocarditis requires hospitalization for monitoring for deterioration. While the majority of patients are discharged home to recover, the current recommendation is for recovering patients to avoid strenuous activity for 6 months. A majority of patients that follow up for cardiac MRI imaging are seen to have scar in long term follow up. There are also case reports of severe morbidity and mortality from vaccine myocarditis resulting in critical illness or death.

Prior episodes of vaccine myocarditis have been linked to an increased risk of myocarditis with future vaccinations

Two case reports from Australia describe myocarditis after administration of the Novavax vaccine to two young individuals who had recovered from mRNA vaccine myocarditis. 

The two case reports from Australia aren’t even the first reports of Novovax myocarditis after mRNA vaccine myocarditis. In August, the CDC reported 29 cases of pericarditis, including five in persons with a history of pericarditis after mRNA COVID-19 vaccine

Importantly, the Novovax vaccine is a protein-based vaccine that was hoped to not be associated with myocarditis as was noted with the mRNA vaccines. Unfortunately, these report of myocarditis occurring after Novovax delivery in patients who had a prior case of mRNA vaccine myocarditis suggests a history of vaccine myocarditis should serve as a contraindication to any future COVID-19 vaccines.

Summary / Recommendations:

Mr. Smith is a 31 year old man with no medical history. He emphatically denies any history of cardiopulmonary disease. He received his first dose of a Pfizer mRNA COVID-19 vaccine in June 2021. He subsequently describes having sharp chest pain over the next few weeks. He did not seek any medical evaluation at the time as he did not link the chest pain with the first dose of the vaccine he received. The pain resolved a few weeks later. He has had COVID twice, first in September of 2020, and his second time in January of 2023.

His cardiac testing completed to date consist of an electrocardiogram and an echocardiogram performed Feb 16th, 2023 that were both normal.

I think it is certainly possible Mr. Smith may have had myocarditis after the first dose of his mRNA vaccine. As I discussed with Mr. Smith, a cardiac MRI would not change my opinion on the matter as a normal result this many months from his original presentation would not rule out acute myocarditis. If he did have a case of vaccine myocarditis after his first dose of an mRNA vaccine, I think he would be at risk for developing myocarditis with another COVID-19 vaccination. I will note here that Mr. Smith did try to fulfill the mandate to complete a primary series of a COVID-19 vaccination by attempting to get a Johnson and Johnson vaccine. He was turned away by the pharmacists who noted the Johnson and Johnson vaccine was not approved to be given after a first dose of an mRNA vaccine.

As I have detailed, while most cases of vaccine myocarditis have not been shown to result in severe morbidity or mortality, there are clearly case reports of severe vaccine myocarditis. Especially given Mr. Smith has had two separate COVID infections, with his most recent infection in January of 2023, it is very unlikely that the unclear benefits of a second dose of a COVID-19 vaccine are outweighed by the risk of vaccine myocarditis.

I understand the committee has concerns beyond individual protection with regards to vaccination as it was hoped that vaccinations against COVID19 would reduce the likelihood of transmission of the virus and thus provide protection to the community in addition to the individual. As you know, the initial randomized control trials were not designed to test for reduction in transmission, and the degree of reduction in transmission is a matter of debate now. Beyond the unknown efficacy of the vaccines related to transmission risk, there does appear to be growing consensus about the equivalence of a prior infection from COVID and vaccination. The meta-analysis on prior infection referenced above prompted the Chairman of Medicine from UCSF, Dr. Bob Wachter to write :

Since nearly all unvaxxed have been infected by now (many>once), study lowers the case for vax mandates, since those w/ prior infection likely have protection not materially worse than if they were vaxxed.

It should also be relevant that Mr. Smith is a non-clinical, remote worker who has no direct contact with patients or other healthcare staff.

For all of the above reasons, I would respectfully ask members of the vaccine exemption committee to reconsider and grant Mr. Smith an exemption from the company’s vaccine mandate.

Yours Sincerely,

Anish Koka MD

Cardiologist

Philadelphia, Pennsylvania

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THCB Gang Episode 117, Thursday February 23, 1pm PT 4pm ET

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday February 23 at 1PM PT 4PM ET are futurist Jeff Goldsmith, and delivery & platform expert Vince Kuraitis (@VinceKuraitis);

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

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Last in Line: Hospitals Brace for a Chilly 2023

BY JEFF GOLDSMITH

As they emerge from the COVID pandemic, US hospitals have a terrible case of Long COVID.  They experienced the worst financial performance in 2022 in this analyst’s 47 year memory.  As the nation recovers from the worst inflation in forty years, hospitals will find themselves locked in conflict with health insurers over contract renewals that would reset their rates to the actual delivered cost of care.  “Last in line” in the US battle with inflation, hospitals will be exposed to public criticism when they attempt to recover from pandemic-induced financial losses. 

Hospital payment rates for commercial payers are backward looking. Commercial insurance contracts between hospitals and health insurers were multi-year contracts negotiated before the pandemic.  They continued in force during the pandemic, despite explosive rises in people and materials costs.    As a consequence, health costs were conspicuously missing from the main drivers of the 2021-22 inflation surge– food, housing, energy, durable goods, etc.    

Hospitals’ operating costs blew up during COVID due to a shortage of clinicians, the predations of temporary staff agencies, shortages of supplies and drugs and crippling cyberattacks that disabled their IT systems.   Hospital losses worsened during 2022 because they are unable to place patients who are no longer acutely ill but who cannot be placed in long term, psychiatric or home-based care (a problem shared by Britain’s disintegrating National Health Service).   Thousands of patients are stuck in limbo in hospital “observation” units, for which government and commercial payers do not compensate them adequately or at all.   

Hospital Finances were Damaged by the Pandemic

Hospitals were, effectively, partially nationalized during 2020 by government mandated or voluntary suspensions of elective care to accommodate COVID patients.   In partial compensation for the resulting losses, hospitals received massive federal assistance from the CARES Act.  The disruption in normal hospital operations was severe enough that CARES funding accounted for a shocking 43% of hospital operating cash flow during 2020, according to Moody’s Investor Service    As the pandemic continued in 2021 and 2022, and federal aid dried up or needed to be repaid, hospitals experienced widening operating losses.

In contrast, health insurers were big financial winners during the pandemic.  The cessation of normal caregiving produced multi-billion  windfalls for health insurers, particularly in the spring of 2020, as their medical expenses fell sharply.  Health insurers profited while hospitals were on the federal ”respirator” and have neatly avoided the post-pandemic cost surge with fixed price contracts. 

Healthcare Cost Pressures Did Not Abate During the Pandemic

Overall, healthcare price increases , and hospitals’ prices in particular, have trailed the Consumer Price Index for almost two full years.  Healthcare spending will likely end up 2022 at around 17% of GDP, the lowest level in fifteen years.  Hospitals actually accounted for a smaller share of US health spending in 2021 (31.1%)  than they did a decade earlier.  By comparison, In 1980, hospitals were over 41% of US health spending!  

Costs, however, are very high.  Half or better of those costs are people costs, which people are in increasingly scarce supply.  Most health systems today are reducing their non-clinical staff but remain desperately short of clinicians.  They have no choice but to pass those higher people costs onto those who pay for care. Otherwise, we will see hospitals close, and if the historic patterns hold, those closures will be concentrated in areas we can least afford them- rural areas and small towns, and the nation’s inner cities.  

The US is not over supplied with hospital capacity.  Indeed, some observers argued that bed capacity was dangerously low for societal needs during the pandemic.   At 2.4 beds per thousand, the US hospital system is far below the bed capacity target of 4 beds per thousand set in the 1970’s US health planning law, and less than half of bed capacity in Germany and France. And despite concerns about excess utilization,  at about 565 bed days per thousand in 2021, hospital utilization in the US is the among the lowest in the OECD countries and is continuing to fall as more care migrates into outpatient settings and the home.  

Hospitals Must Do a Better Job of Telling their Story

The grim reality is that  hospital systems were basically all we had for public health infrastructure during the pandemic and we will certainly need them again in future crises, whether another pandemic, mass shootings or hurricanes.    If hospitals are to obtain higher rates from the government and commercial payers, they must justify them by sustained and aggressive cost containment activity.

 Hospitals must also demonstrate the value of the public service they perform and the value for money relationship of the care they provide for their patients. And-a point of emphatic agreement with the critics-  there is no valid excuse for non-profit hospitals not putting back into their communities tangible benefits that exceed the value of their tax-exemption. Above all, their leadership must remain humble and constructively focused on the communities they serve.  They have to do a much better job of explaining, in accessible and human terms, what they do,  why their care costs so much, and what they are doing to make care more affordable.

Jeff Goldsmith is President of Health Futures, Inc. & a long time THCB Contributor.

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There Is Something About Trains, Indeed

BY KIM BELLARD

Like many of you, when I heard about the Norfolk Southern train derailment in East Palestine (OH) on February 3, my heart went out to the people in that community. The train was carrying some hazardous materials, and no one was quite sure what was vented, especially when officials did a “controlled burn.”  Still, though, I didn’t think much about it; although I live in Ohio, I’m about as far away as one can be within the state.

Yesterday my local water company shut off access to water from the Ohio River. “We are taking this preventative step to ensure the health, safety, and confidence of residents,” said Cincinnati Mayor Aftab.  (Note: it reopened access today).

East Palestine isn’t all that close to the Ohio River, but whatever chemicals got into the local streams eventually started reaching it, and a “plume” of them slowly meandered the 400 miles downstream to here. Initially, the water company noted how small the particulate levels were – well below any danger – and that normal filtering processes would take care of them. Then they announced that they’d add a second filtering step, just in case.  I guess people weren’t reassured, because they still closed the intakes, if only for a day.

I can only imagine how worried the people in East Palestine must be.

The scary thing is that this derailment was not a freak occurrence.  There are about 1,000 derailments every year. Fortunately, most don’t involve either hazardous materials or result in deaths. If it’s any consolation – and it shouldn’t be – most hazardous material spills come from trucks, not trains (but, then again, trucks carry the most freight).   The odds are against bad things happening. But, with 1.7 trillion ton-miles of freight carried by train every year, the odds eventually result in an East Palestine (and there were train derailments with hazardous materials in both Houston and Detroit since East Palestine’s). 

When I first heard about the derailment, I assumed it was poorly maintained tracks. Although railroad infrastructure earned a “B” in the most recent civil engineers’ report card, the U.S. has a history of underinvesting in infrastructure, the recent Bipartisan Infrastructure Bill notwithstanding. The freight companies claim to invest some $20b annually on capital expenditures and maintenance, including both the trains and the tracks, but when I see railroad tracks or freight trains on them, I’m not usually particularly dazzled; both look like they’ve been there for fifty years. 

There was also speculation that the crash was due to the lack of more modern Electronically Controlled Pneumatic (ECP) brakes, which in 2017 the railroad industry successfully blocked regulations requiring, but it appears that a wheel bearing overheated and failed.

One thing that critics point to is that the Norfolk Southern just recorded record profits, and had $18b in stock buybacks and dividends over the past five years, while seeing accidents rise.  They’re not alone.  

“For years, the railroads have fought all kinds of basic safety regulations — modern braking systems, stronger tank cars for explosive materials, even information about what’s on trains passing through communities — based on an argument that it simply costs too much to protect our lives, health, and our air and water,” Kristen Boyles, a managing attorney at Earthjustice, an environmental group, told The New York Times. “It’s disgusting to find out that at the same time these companies have been making massive shareholder payments.”

Keep in mind – these are the same railroad companies who do not give its workers paid sick leave, whose scheduling policies make Amazon look good, and who only averted a railroad workers’ union strike last December when Congress stepped in.  

Look: it could have been worse. The train could have been carrying liquified natural gas (LNG). Adele Peters, in Fast Company, warns:  “In a crash, a single train car filled with LNG could produce a fireball up to a mile wide and send shrapnel flying; 22 tank cars filled with LNG have as much energy as the bomb that destroyed the Japanese city of Hiroshima in 1945.”  And there are plenty of other dangerous materials traveling through our communities that we’ll only know about when their train derails.

Despite all this, freight trains are still probably safer than trucks (although when there is an accident, ones with trains are likely to be worse).  Our society could not exist without freight carrying them and the materials needed to make them. I just wish we prioritized safety more over profits. 

Then, again, the civil engineers warn that our roads and bridges are crumbling, our airports and ports are a disgrace, our dams and levees are failing, our hazardous materials are poorly stores, and our water systems are extremely antiquated.  We’re living with Third World infrastructure, and we don’t seem to care.  

One of my local news channels noted that, despite the water company shutting down access out of concern for minute exposures to the toxic materials from the derailment, there are some 37,000 water lines locally that have lead pipes, which put people at far more risk. The water company thinks it will take another thirty years to replace them. Out of sight, out of mind.

We respond in the short term to disasters, but we’re terrible about long term investments in averting or minimizing them. Despite the furors at the time, neither Jackson (MS) nor Flint (MI) yet have safe, reliable water after their respective disasters.  Houston is still at grave risk of future floods despite the 2017 disaster. Pick a disaster, fast forward a few years, and how often have major changes been made as a result?

And, of course, one only has to note that we could have both dealt with COVID much better than we did, or could be doing much more to prepare for the next pandemic, but, if anything, we’re less prepared than before it hit.  Planning, preparation, public health and safety are not our strong suits.    

I get that there will always be accidents.  Bad things sometimes happen. I get that more regulations won’t stop all of them. I get that, in total, there are probably too many regulations.  I hope that the Infrastructure Act starts to make a dent, soon.  But, come on, how many East Palestines do there have to be before we take safeguarding our health more seriously? 

As a NYT opinion piece lamented: “It shouldn’t take a chemical cloud over a community in the American heartland to compel the government to protect its people.” Amen to that.

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

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Matthew’s health care tidbits: Medicare Advantage is now a provider fracking contest

Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

Yes it’s time to talk Medicare Advantage (MA). It’s been a huge couple of weeks for the world of MA. On the commercial side, CVS bought the biggest pure play MA provider, Oak Street Health for $10bn. This pissed me off as if they paid $2 a share more I’d have made a profit on the stock I foolishly bought “on a dip” in 2021.

But this amazed many of us on THCB Gang, as they paid a huge premium and it works out to some $60k per patient. Now health care organizations have been overpaying for patient “lives” as long as I can remember–going at least as far back as Aetna nearly going out of business when it bought US Healthcare in 1996. So why is today’s incarnation of Aetna buying providers?

Well that’s to do with the regulatory side of MA. I have been on record since the very first post of THCB that Medicare FFS is an inefficient and expensive program–even if 80% of American hospitals say they lose money on it and have to charge commercial insurers more to make up for it. But while it’s possible to agree with George Halvorson that MA delivers better care at a lower cost than FFS Medicare, it is simultaneously possible to believe that MA costs more than it should. That’s because of aggressive RAF upcoding that’s been built both into home visits from companies like Signify and also into the EMRs doctors have been using to code MA members’ health status.

There are lots of proposals on how to fix this–including this one from Chenmed on how to change MA from paying for inputs (i.e how sick people are when they join MA) to outputs (how much better they got while in MA). But it’s clear that CMS is now officially coming after upcoding including full cross plan audits back to 2018. Even if not back to 2011. The MA plans will grumble about those past audits and tie CMS up in court but they know going forward the game is up

To make more money in MA they need to get hold and shake loose or frack some of the 85% of the premium that goes to provider organizations. Hence they are all getting into bed with them or buying them outright. UHG, Humana & now Aetna/CVS have been buying physician groups that serve MA populations at a quickening rate, and their goal is to put more of the 50% of seniors already into MA into those groups.

Will this save any money?  Well probably not, at least not yet. Humana has been reporting on the costs in its full risk capitated MA groups versus its FFS ones for a couple of years, and the difference is a rounding error. But the point is that the next war in Medicare Advantage is going to be what happens inside these plan-owned medical groups. So expect a lot more scrutiny of both costs, outcomes and patient experience within MA focused medical groups starting about now. 

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All Three Legs of the Obamacare Stool Are Working Well – Part 2

BY GEORGE HALVORSON

2022 Medicare Advantage data gathering process change made last year just made upcoding for plans irrelevant and impossible, but the critics do not accept that it happened. 

CMS just ended that upcoding debate for 2022 by completely killing the coding system for the plans, effective immediately. The plans can’t code risk levels up because the coding system was eliminated entirely for 2022.

RAPS is dead.

The payment approach for Medicare Advantage now has no upcoding components and the government just used their new and more accurate numbers to create the 2023 payment level for the plans.

The numbers went up a bit with the real risk levels because the plans actually seemed to have been undercoding in spite of their best efforts to have higher numbers in their RAPS data flow.

We should now be able to put that issue to bed and look at what has been accomplished overall by the Affordable Care Act.

The Medicare Payment component of the Affordable Care Act just evolved to a new level — and the entire Obamacare package should now be recognized for what it is now and what it has become. 

When the Affordable Care Act was designed, there were people helping with that process who understood that the only way of getting care in America to continuously improve is to buy care as a package, and not by the piece, and to reward the organizations who re-engineered care for achieving those goals in ways that encouraged using the best tools for care delivery in our markets.

The Medicare Advantage plans all know that clean socks and dry feet reduce foot ulcers that create 90 percent of amputations by 40 percent. The plans also know that congestive heart failure is extremely expensive and painful, and they identify the high-risk patients and help them reduce their risk by doing helpful things in people’s homes to make that happen. Some plans even have scales that send an alert to the care plan nurses when people have unexpected weight gains from fluid retention that indicated a CHF crisis is impending.

Interventions at that moment in time work — and the JAMA study cited above shows that the plans have 40 percent fewer hospital admissions for both congestive heart failure and asthma.

Managing blood sugar for diabetic patients cuts blindness by 60 percent for the patients who achieve that goal — and one of the most important goals in the Medicare Advantage five-star plan has always had blood sugar as a major priority. The plans even improved performance in that area under Covid.

The tools used by the plans are very flexible and are aimed at continuous improvement in many settings. The overlap with other patients in those settings is significant because it’s too hard for caregivers to deliver multiple patterns of care for their patients.  

The Affordable Care Act also aspired to improve care for everyone — and it’s good for the country that most major employers are self-insured for their care, and it’s good that the vast majority of those employers hire administrators to manage their self-insurance.

The organizations who do that administrative work for the employers tend to be the same major carriers who also own the vast majority of Medicare Advantage plans and the vast majority of Medicaid administrators and they have an overlap with the care goals set by the significant majority of union trust fund administrators as well. Over 5 million union members are in their own Medicare Advantage plans, and those union plans tend to have some of the highest Medicare Advantage five-star quality scores in the country.

So when the people designing the Affordable Care Act were doing that design work for care improvement, they aspired to have the care improvement spill over to the rest of American health care.

This is the right time for that spillover of best processes to happen.

We should be on the cusp of a golden age for care delivery in America.

We should be able to use artificial intelligence and FIHR like data connection systems to do things like the cancer moon shot now being set up for the best cancer sites in America to make care both cheaper and better for everyone. The very best care team will be able to predict multiple types of cancer a year or more in advance with simple blood tests and other monitoring devices, and that could significantly reduce the cost of care for us as a country, because a stage 1 cancer costs a lot less to treat than a stage 4 cancer.

Fee-for-service Medicare will not support any of those enhancements or improvements in care because they have never supported that level of care improvement and flexibility. The Medicare Advantage plans will now have some plans that support everything that happens to enhance care, and that enhanced care from those programs will create a competitive advantage for those plans that other plans will need to follow by also improving care.

That’s obviously good for everyone. It’s how markets should work and it’s very different from how market forces have been working in fee-for-service American health care.

So, as we look at the Affordable Care Act, the key pieces are clearly supporting some things we need to happen to make care affordable for the country — and we should understand that process and build on those successes in every area that they’re happening, and we should have it anchor continuously improving care for us all.

When the Affordable Care Act was passed, the health care economists fairly consistently projected that America was on a slippery slope to spend more than 20 percent of our GDP on care — and the new markets that use better tools for many patients, and that create better purchasing mechanisms in both Medicaid and private insurance, seem to have had a major positive impact on that agenda.

We are now at 18 percent of our GDP being spent on care — and that is high, but significantly better than the path to 20 percent that we were on before the law was enacted. The timing of those trajectories tells us that is isn’t coincidental.

The problem we face today is that there are some serious enemies to the process of using Medicare Capitation and Medicare Advantage to improve care.

We need to keep the people who clearly and openly still want to kill all of the plans, because they think some version of election fraud happened in some settings, from doing the damage that those opponents seem committed to be doing in order to make Medicare Advantage disappear and die.

That warning about those critics at this point in time should not be necessary, but those people who want to kill those programs and processes do exist and that death is their open goal — and we just need to recognize what they’re doing and keep them from sneaking in back doors and using distorted data flows of various kinds to somehow make those changes happen in damaging ways for our care as a country.

Let’s celebrate Obamacare on each level that it exists.

The Medicaid program is a huge win.

The employment direct access and open enrollment insurance programs and the functional insurance exchanges in every state are major wins.

The Capitated Medicare program is creating better care and doing it for about 10 percent less money than fee-for-service Medicare spends on those same patients in all of those counties.

The people who lost their political careers because they got that Affordable Care Act law passed should be heroes to us now because the wins are so clear today for what they put in motion, and Americans have better lives because those programs exist.

Thank you.

George Halvorson is Chair and CEO of the Institute for InterGroup Understanding and was CEO of Kaiser Permanente from 2002-14.

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THCB Gang Episode 116, Thursday February 16 1pm PT 4pm ET

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday February 16 at 1PM PT 4PM ET are futurist Ian Morrison (@seccurve); fierce patient activist Casey Quinlan (@MightyCasey); delivery & platform expert Vince Kuraitis (@VinceKuraitis); and Olympic rower for 2 countries and all around dynamo Jennifer Goldsack, (@GoldsackJen).

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

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Let’s Finish The Job

BY MIKE MAGEE

In President Biden’s State of the Union Address, the most oft repeated phrase was “Let’s Finish The Job!” This came as part of an appeal for partnership as well as an assertion that in his first two years as President much had been accomplished.

Several days later, as if on cue, U.S. Senator Amy Klobuchar (D-MN) and Senator Chuck Grassley (R-IA), joint chairs of the Senate Subcommittee on Competition Policy, Antitrust, and Consumer Rights, announced that two bipartisan pieces of legislation focused on reducing the price of drugs to consumers had passed the Senate Judiciary Committee.

Both bills focus on the range of shenanigans Pharma firms have engaged in to extend their 20 year patents on blockbuster brands and delay generic versions from coming on the market.

The first bill – the Preserving Access to Affordable Generics and Biosimilars Act – is designed to prevent Big Pharma firms from flooding the FDA with sham requests for patent extensions. In the process, opponents have popularized a new term – “patent thicket” to describe the barrage of skimpy patent extension tricks companies use to extend their original 20 years of exclusivity. 

How bad can it get? Well in 2022, AbbVie Pharmaceutical successfully fought off accusations that its 132 additional patent requests were not excessive for their blockbuster blood thinner, Humira. Lucky for them, a friendly judge, U.S. Circuit Judge Frank Easterbook agreed, justifying his decision by noting that “Thomas Edison alone held 1,093 U.S. patents.” Funny thing was that the patent for Humira ran out in 2016, but they’re still in control of the money maker now 7 years later. Wow!

The second new bill likely has the longest acronym in legislative history. It’s STALLING for “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics.” The meat of the proposed legislation would block bribery of Generic Firms on an institutional scale by Big Pharma. These various “pay-to-delay” scams pay off smaller generic firms willing to voluntarily pull or delay their legal filings of generic substitute products for drugs going off-patent.

Sen. Klobuchar has traveled this road before. She was instrumental in loading the Inflation Reduction Act with a provision that allowed Medicare officials to negotiate prescription drug prices. In 2022 she also pressed the Department of Justice and the Federal Trade Commission to investigate Janssen, Bristol-Myers Squibb and Pfizer for collusion on pricing of blood thinner medicines after uncovering lock-step pricing increases of Xarelto and Eliquis.

In the State of the Union, President Biden expressed undying faith in American ingenuity and our willingness, when push comes to shove, to collaborate for the greater good. Turns out both are true. When it comes to greed, there is no end to the ingenious strategies that a bucket full of well paid lobbyists can come up with. 

As for collaboration, leave it to Big Pharma to be so consumed by the joys of profit to push the system to the point where politicians from both sides of the aisle are willing to join hands and scream “Enough is enough!”

Mike Magee MD is a Medical Historian and author of CODE BLUE: Inside the Medical Industry Complex.

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