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Category: Health Policy

A big data COVID train wreck

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BY ANISH KOKA

If there was any doubt the academic research enterprise is completely broken, we have an absolute train wreck of a study in one of the many specialty journals of the Journal of the American Medical Association — JAMA Health.

I had no idea the journal even existed until today, but I now know to approach the words printed in this journal to the words printed in supermarket tabloids. You should too!

The paper that was brought to my attention is one that purports to examine the deleterious health effects of Long COVID. A sizable group of intellectuals who are still socially distancing and wearing n95s live in fear of a syndrome that persists long after a person recovers from COVID. There are any number of papers that argue a variety of putative mechanisms for how an acute COVID infection may result in long term health concerns. This particular piece of research that is amplified by the usual credentialed suspects on social media found “increased rates of adverse outcomes over a 1-year period for a PCC (post-COVID conditions) cohort surviving the acute phase of illness.”

In this case PCC (Post-COVID conditions), is the stand-in for Long COVID, and leading commentators use this paper to explicitly state that heart attacks, strokes and other major adverse outcomes doubled in people post-COVID at 1 year…

It is a crazy statement, and anyone regurgitating this has no business commenting on any scientific papers. Let me explain why.

In order to find out about the potential ravages of long COVID researchers need to be able to compare outcomes between those who were infected with COVID and now have long covid to those who were never infected with COVID. At this point finding a large enough group of people that never had covid is impossible, because everyone in the world will have been infected with COVID many, many times. It’s also really hard to define the nebulous long COVID because a study after study finds no clear objective markers of the disease.

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Matthew’s health care tidbits: Oh, the DEA makes me sigh….

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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

I have always thought that the dual role of the Drug Enforcement Agency (DEA) was an anachronism that severely hampers America’s complex relationship with pharmaceuticals. Congress deems some medicines legal and regulates them via the FDA, and deems others illegal and tells the DEA and other law enforcement agencies to attempt to control their supply. Leaving aside the basic futility of this task, somehow DEA was also given the task of regulating the prescribers of legal prescription (and non-prescription) drugs–in particular those around controlled substances.

This has led to decades of DEA-led persecution of doctors, patients and even convenience store clerks in the name of reducing the diversion of opiates and methamphetamines. Of course going after any of these folks is much easier and less risky than hunting a Mexican cartel or busting real criminals, so it’s easy to see why the DEA has taken that approach. Has it worked in reducing the supply of opiates? Maybe. Has it had any impact on the opiate crisis? Not really. Have a whole lot of patients been caught in the crossfire? Yup.

Now the DEA is moving onto the next phase–re-regulating the online prescribing of controlled substances that was liberalized at the start of the public health emergency in 2020. As you can imagine, their proposals are not exactly bursting with reason.

The DEA is essentially banning all controlled prescribing without a face to face visit first. This is despite the fact that the demand for those mental health medications increased dramatically during the pandemic as rates of depression and anxiety went up by a factor of three. While you can argue that in 2021 and 2022 some online services (notably Cerebral) may–and I stress may–have crossed the over-prescribing line for ADHD and other conditions, there’s no evidence that what happened is any worse than the in-person care that the DEA has been inadequately overseeing for decades. More importantly, those online services have already pulled out of those exact therapeutic markets the DEA is alarmed about. Who is left providing online ADHD care? Local clinicians and reputable services. And of course DEA knows full well, and is doing nothing about, the lack of access to mental health professionals that existed long before the increase in demand.

Is there any reason to suspect DEA will improve the quality of the system dealing with these medications? Highly doubtful. There are two current examples suggesting why not. First, due to the increased demand from the pandemic induced mental-health crisis and production problems at pharma company Teva, there’s a massive shortage of ADHD medication already. The DEA could help patients out here, but have declined to increase production quotas–sending millions of patients and their parents on a wild goose chase hunting down pharmacies with actual supply of Adderall and related meds.

Secondly, the DEA wants to also ban the the online prescribing of another drug, buprenorphine, which is used to help wean patients with substance use disorder off opiates and other substances. OK, so there’s a one month grace period here but essentially this is a short-sighted ban that will directly lead to patients going to the black market to acquire opiates, leading to more addiction and death.

My conclusion is that the DEA should be removed from its oversight of licensed clinicians and that role be given to FDA or HHS. At the least these proposed  regulations should be abandoned and rolled back to what we have now. The only good news is that there is still time to comment on the regulations. I went and did so and I hope you will too. Patients have suffered enough already.

Ecology Rescued the AMA and Medical Professionalism Beginning in 1870. Will technology and science rescue the profession once again?

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BY MIKE MAGEE

Medicine does not exist in a vacuum. The trusting relationships that underpin it function within an ever-changing environment of shifting social determinants. This is not new, nor surprising.

Consider for example the results of their 1851 survey of 12,400 men from the eight leading U.S. colleges had to be shocking. The AMA was only four years old at the time and being forced to acknowledge a significant lack of public interest in a physician’s services. This in turn had caused the best and the brightest to choose other professions. There it was in black and white. Of those surveyed, 26% planned to pursue the clergy, 26% the law, and less than 8% medicine.

It wasn’t that doctors with training (roughly 10% of those calling themselves “doctor” at the time) lacked influence. They had been influential since the birth of the nation. Four signers of the Declaration of Independence were physicians – Benjamin Rush, Josiah Bartlett, Lyman Hall, and Mathew Thorton. Twenty-six others were attendees at the Continental Congress. But making a living as a physician, that was a different story.

During the first half of the 19th century, the market for doctoring went from bad to worse. Economic conditions throughout a largely rural nation encouraged independent self-reliance and self-help. The politics of the day were economically liberal and anti-elitist, which meant that state legislatures refused to impose regulations or grant licensing power to legitimate state medical societies. Absent these controls, proprietary “irregular medical schools” spawned all manner of “doctors” explaining why 40,000 individuals competed for patients by 1850 – up from 5000 (of which only 300 had degrees) in 1790.

The ecology of 1850’s medicine couldn’t be worse. The marketplace was a perfect storm – equal parts stubborn self-reliance, absence of licensure to promote professional standards, diploma mills that showed little interest in scientific advancement, and massive unimpeded entry of low quality competitors. 

The legitimate doctors in those early days saw 5 patients on a good day. Horse travel on poor roads, and the absence of remote systems for communication, meant doctors had to be summoned in person to attend a birth or injury. And patients lost a day’s work to travel all the way to town for a visit of questionable worth. The direct and indirect costs for both doctor and patient were unsustainable. As a result, most doctors had multiple careers to augment their income.

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Let’s Do Public Health Better

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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.

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Last in Line: Hospitals Brace for a Chilly 2023

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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.   

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

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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. 

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Let’s Finish The Job

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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. 

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All Three Legs of the Obamacare Stool Are Working Well

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BY GEORGE HALVORSON

When the Affordable Care Act was passed, the politics were so intense and the debates were so filled with rhetoric in all directions that most people actually didn’t understand that there were three major component parts to the strategy and program that function very directly as a package, and should be looked at now in the context of several years of implementation to see how each part of that law is currently doing.

Medicaid was our first priority.

The first component part — and the one that had the highest need for passage when the law was passed because we were doing such a horrible job as a country in providing coverage to our children and to our low-income people — was Medicaid expansion.

We were the only country in the industrialized world that did not have health care available to our low-income children, and that deficiency damaged so many people and was so terrible as a reality that we needed to correct it as soon as we could.

That program is on the right track.

Most states have now used the full Medicaid package and we now have a total of 90 million people enrolled in Medicaid. About 41 million of the members are in the CHIPS program, and a majority of the births in a majority of the states are now Medicaid births.

The states have all used a number of modern care improvement tools to provide and deliver significantly better care than the old Medicaid programs that are far too often delivered to their beneficiaries.

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What Scientists and Historians Understand: Without Truth, Progress Is An Impossibility

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BY MIKE MAGEE

“This too will pass, honey!” That’s what my mother used to say when any of my eleven brothers and sisters or I seemed to be overwhelmed by whatever. And largely, now, three quarters of a century since my birth, she was mostly right. Whether in personal lives or the life of our nation, over a span of time, the slope has been slight, but upward.

But there are weeks, like this past one, where we are forced to witness the beating death of an innocent 29 year old black man at the hands of police in the very city where Martin Luther King was slaughtered 55 years ago, when it would be easy to lose hope. Why not, as Trumpets actively promote, just lie? Why not create “alternate realities?”

Witness Gov. Ron DeSantis. What he fails to realize, in his attempts to white wash Black History from Florida schools, is that the accurate and full disclosure and discussion of our complicated American history ultimately supports progress and optimism. This is because the record shows that we have the capacity (admittedly in very small steps) to improve ourselves and our ability to manage self-governance.

Science has a long history of opposition to politicians who oppose truth-telling. Louis Pasteur famously urged fellow scientists to “worship the spirit of criticism.” When challenged to provide a rationale for his faith in full disclosure, he replied, because “everything is fallible.”

There was another scientist of the same era who was born with an iron spine and a love for honest learning. Her mother had emigrated from Wales shortly after our Civil War. Born into a farming family on January 29,1881, Alice Evans lived to be 94. Along the way she became the first women scientist to work as a bacteriologist for the U.S. Department of Agriculture, and the founding president of the Society of American Bacteriologists (American Society for Microbiology).

Descriptions of her include an “unending intellectual curiosity, independent spirit, and unflinching integrity.” She received her education at Cornell’s College of Agriculture and at the University of Wisconsin’s College of Agriculture. After working on improving the flavor of cheddar cheese for three years, she headed to Washington D.C. to join the new federal Dairy Division. She had applied as A. Evans at the urging of her male mentors knowing the federal government had no taste for female scientists. As she was later quoted, “I was on my way to Washington where I had not wanted to go and where I was not wanted.”

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Practicing Medicine without a License: When Patients and Politicians Play Doctor

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BY MICHAEL KIRSCH

We’ve all heard the adage, leave it to the professionals.  It’s typically used when an individual has wandered out of his lane.  How many folks go beyond their knowledge and skills with home projects, for example, who must then hire a real professional to mop up the mistakes?  Luckily for me, the only tools that I – a gastroenterologist – know how to use are a colonoscope and an endoscope, so there’s no chance that I will be tempted to perform any plumbing or electrical tasks at home.  

Although patients are not medical professionals, they routinely bring me results of their own medical research which suggest possible diagnoses and treatments.  Often, these are patients whom I am meeting for the first time.  I applaud patients who strive to be informed participants in their care. Indeed, there have been instances when a patient has brought me a valuable suggestion that I had not considered.  But these are uncommon occurrences.  A few computer clicks by a patient is not equivalent to the judgment and experience of a seasoned medical professional.  It’s unlikely, for example, that I will agree that a patient’s elevated temperature is caused by malaria, despite this appearing on a patient’s internet search on the causes of fever.  

However, even when I feel that a patient’s research results have no medical merit, the ensuing conversation is always valuable for both of us.  I am in the room and can address the issue directly in real-time.  I am the patient’s guardrail to protect him from careening off the road.  I can explain right then the importance of being guided whenever possible by sound medical evidence.  So, while I truly welcome the dialogue and recommendations from patients, I think that the maxim leave it to the professionals applies. Isn’t this why patients come to see us?

There’s a new player on the scene masquerading as medical professionals dispensing medical advice to the public.  And in this case, there are no effective protective guardrails protecting patients as we doctors routinely do.  I am not referring to middle of the night telemarketers or companies promising that probiotics are the panacea of our time.

As absurd as this sounds, politicians are now authorizing medical treatment for various diseases and conditions. Politicians? Could this be true? 

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