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Category: Health Policy

Medicare Is Now Profitable as a Total Program Because of Medicare Advantage

By GEORGE HALVORSON

Medicare made $83.4 billion very real dollars in 2022. The 17% discounts below the average cost of fee-for-service Medicare, that happen in every county for Medicare Advantage, have been very real and extremely successful in paying for Medicare coverage — in a way that now makes the program a profit center for the US Government.

You can see the actual financial report page from the 2023 Medicare trustee report below. It shows that the Medicare trust fund grew in 2022 for the first time in decades. More than half of the Medicare members are now enrolled in Medicare Advantage plans. Those members cost significantly less than their equivalent fee-for-service Medicare patients.

These are the actual numbers from the trustee report.

The Medicare trustee report says that the total Medicare program grows per member by 6.7% every year. They project in that report that they expect that rate of increase to be consistent over the next decade. The enrollees in the Medicare Part A and Part B programs have expenses that increase slightly above that number every year. That’s been true for a couple of decades.

Medicare loses money on every Part A and Part B member when expenses for those programs are higher than the 6.7% average.

Medicare Advantage costs for Medicare Part C are increasing at a lower rate than that number. That means that Medicare makes money and creates a surplus with the Medicare Advantage patients.

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A New Day for Parkinson’s Disease Research Is Near

By STEVEN ZECOLA

The U.S. Department of Health and Human Service (“HHS”) is responsible for a wide range of activities relating to medical and public health. It has 60,000 employees and a $1.7 trillion annual budget with approximately $140 billion for discretionary spending. For the past 13 years, HHS has been spearheading a National Plan for addressing Alzheimer’s disease – with some notable successes.

Given its resources, expertise and charter, HHS should launch a National Plan to cure Parkinson’s disease patterned after its approach on Alzheimer’s disease.

Legislation, or Not

The U.S. House of Representatives has passed H.R.2365, the National Plan to Cure Parkinson’s Disease.

The bill would establish HHS as the central point for strategic direction and coordination of PD research.  It would require formation of a broad-based Advisory Panel to provide strategic advice and any on-going course corrections.

There is nothing preventing HHS from putting the structure of H.R. 2365 into effect now, and it should do so without waiting for Senate action or inaction. There is no incremental funding required to implement this National Plan, nor is any Congressional approval necessary.  This approach would mark an important step towards finding a cure for Parkinson’s disease, and is well within HHS’s charter.

A Cross-Section of Policy and PD Research

For those who have studied the application of regulatory policies to Parkinson’s disease research, it does not provide a productive narrative.

Levodopa was first discovered in 1910. In 1975, after 14 years of its “miraculous” treatment of PD symptoms, the FDA approved the drug. Levodopa does not cure or delay the progression of the disease. Yet, it has remained the gold standard of treatment of PD for the past fifty years. That is not to say there has been insufficient research or inadequate FDA approvals.  Rather, it’s a question of where the research dollars have been funneled. It turns out that levodopa becomes less effective over time and eventually produces uncontrolled shaking. Therefore, research dollars have been targeted toward drugs that delayed the need for levodopa or controlled its side effects.

An exception to this approach was Geron, which became a leader in embryonic stem cell research. It had raised $100 million to conduct clinical trials. However, most of that money was consumed by undertaking thousands of experiments on mice under the “guidance” of the FDA. Nevertheless, Congress saw the potential of embryonic stem cells, and passed the Stem Cell Research Enhancement Act.

While Congress cheered, the Evangelical movement viewed embryonic stem cell research as barbaric and akin to murdering a human life. It didn’t matter that embryonic stem cells could not become a living being unless they were implanted in a woman’s womb, and this step wasn’t part of the research efforts.  Notwithstanding, the Evangelicals convinced George W. Bush to veto the legislation, and a promising path for PD research was shut down.

More recently, the House has passed bills for a National Plan to Cure Parkinson’s in its last two sessions, but the Senate has failed to act, despite a myriad of sponsors of a bill with similar provisions.

Building Upon Lessons from the Past

In 2011, Congress passed legislation establishing a National Plan to Address Alzheimer’s disease (“NAPA”).  Thirteen years later, there are many lessons to be learned from that effort that can be applied in a National Plan for PD. Of particular note, the original plan had five objectives including to “Prevent and Effectively Treat AD/ADRD by 2025”. 

The first report by the Advisory Council specified that the current “level of resource commitment falls drastically short of the funding needed to accelerate the pace of research on prevention, cures, and treatments for AD”. It also recommended that the Secretary examine “[h]ow HHS uses existing authorities to reduce drug development barriers and accelerate development of new therapies” and specifically called for recommendations to “accelerate the FDA review process”.

What happened?  While funding was increased substantially and hundreds of potential treatments have been identified, only two drugs have been approved by the FDA under an “accelerated” review process.

While HHS may express pride in the accomplishments from the Alzheimer’s National Plan, it should conclude that the process to get an effective treatment identified and approved takes too long. For example, the FDA provides “guidance” to researchers even before clinical trials are submitted. It also regulates the provision of genetic tests. These actions needlessly slow development and reduce innovation.  

Similarly, the FDA’s regulation of Phase 1 and Phase 2 trials slows down development and does little to benefit the public interest. The FDA points to multiple ways that it has accelerated the drug approval process.  But the reality is that progress from PD research has been lacking.

On the other hand, in 2019, researchers issued a report – based on real-world observations — that Terazosin resulted in a lower incidence of PD and a slower development of the disease when it did occur.  Terazosin has been used for over 35 years to treat other maladies. Yet the drug underwent a 13-person Phase I trial to determine if it is safe. This phase 1 trial took several years to complete. This approach was a distraction that caused unnecessary delay and cost under the FDA’s regulatory regime.

The FDA will say that its rules do not require 3 (or more) trials nor does it mandate a particular trial design. This is disingenuous. Companies spending hundreds of millions of dollars on research cannot afford the risk of shirking the FDA’s standard procedures.

Taken as a whole, the HHS should limit the FDA’s involvement in PD research to approval of Phase 3 trials. Such an approval process will speed development and foster innovation yet maintain adequate safety controls by the FDA. Research organizations would be less constrained in developing their strategies and would be held to more responsibility for their approach to research.

A Multivariate Solution Is Likely to be Required

PD is a complex disease that has different manifestations when looked at from a genetic, diet, exercise, environmental (pesticides/pollution/solvents), vitamin, drug, electronic, radiation and possibly other perspectives. As such, a multivariate solution is likely to be required to successfully treat PD. 

Such a solution will not be well accommodated by the current FDA review process, with each different combination of therapies being subjected to regulatory review and intervention.  The process could drag on for decades.

HHS should recognize the need for a multivariate solution and plan accordingly, as described below.

Data Collection to Identify Multivariate Solutions

In 2010, The Michael J. Fox Foundation launched the Parkinson’s Progression Markers Initiative (PPMI) to find the biological markers of Parkinson’s onset and its progression. That study led to the impressive finding of a tool that can detect pathology not only of people diagnosed with Parkinson’s, but also in individuals that are at a high risk of developing it. However, after ten years, that study has only a few thousand participants. HHS should endorse and expand the scope of that study.

The “second version” of PPMI should be an overlay study designed with the end game in mind. That is, it should produce a mapping of individual people’s PD “score” over time against all relevant explanatory variables that could possibly impact PD for each individual. Such an approach is superior for identifying multivariate solutions.

To accomplish this objective, each participant would establish and maintain a unique portal for his/her own explanatory PD variables. The portal would include a series of hard-coded entry requirements covering scores of inputs. The initial set-up could be completed in piece-part (with the availability of outside assistance) and would auto-populate with each quarterly update (allowing for input of any changes that occurred after the initial set-up). The portal would interface with the growing number of portals of individual healthcare providers and would collect the diagnostic information from those systems. Personal “meters” of this sort are now actively being deployed in the field of Alzheimer’s disease given that certain therapies and drugs have shown progress against that disease.

As the above information from participants is collected over time, artificial intelligence software would be used to identify combinations of diet, exercise, supplements, genetics, sleep habits, therapies, electronics, radiation and drugs that point towards promising results. New treatments such as those undertaken in clinical trials would be added to the participant’s portal as they as are pursued by those individuals. All of the patient’s existing drugs would be analyzed in the context of all other relevant explanatory variables for that participant – over time.

As importantly, a comparative, quantifiable measurement of PD over time for each individual is required. The PPMI was originally focused on identifying a marker for PD and therefore uses a series of qualitative questions to gauge the patient’s development of PD symptoms over time. In contrast, the emphasis for this data collection effort should shift to the explanatory variables affecting PD progression over time.

In terms of the participant’s PD score, I believe a modified version of the Fitness program currently designed for the computer game “Wii” (which provides a quantitative estimate of an adult’s age based on how that person performed on certain activities) would provide more reliable results. Each participant would provide his/her own age estimator from the computer program on a quarterly basis as well as provide any updates for the various explanatory variables.

Once this revised format is established, the HHS should establish a goal of enrolling 100,000 PD participants into the study within two years.

A Better Approach for PD Research Is Available Now

HHS can – on its own accord – dramatically improve the efficiency and effectiveness of Parkinson’s research by: 1) adopting the industry-wide structure it utilized for Alzheimer’s disease, 2) embracing and expanding upon the current PPMI study and 3) limiting the FDA’s involvement in research to the approval of Phase 3 clinical trials.

Steve Zecola sold his web application and hosting business when he was diagnosed with Parkinson’s disease twenty three years ago.  Since then, he has run a consulting practice, taught in graduate business school, and exercised extensively

The Money’s in the Wrong Place. How to Fund Primary Care

By MATTHEW HOLT

I was invited on the Health Tech Talk Show by Kat McDavitt and Lisa Bari and I kinda ranted (go to 37.16 here) about why we don’t have primary care, and where we should find the money to fix it. I finally got around to writing it up. It’s a rant but a rant with a point!

We’re spending way too much money on stuff that is the wrong thing.

30 years ago, I was taught that we were going to have universal health care reform. And then we were going to have capitated at-risk entities. then below that, you have all these tech enabled services, which are going to make all this stuff work and it’s all going to be great, right?  

Go back, read your Advisory Board Company reports from 1994. It says all this.

But (deep breath here) — partly as a consequence of Obamacare & partly as a consequence of inertia in the system, and a lot because most people in health care actually work in public utilities or semi-public utilities because half the money comes from the government — instead of that, what we’ve got is this whole series of massive predominantly non-profit organizations which have made a fortune in the last decades. And they’ve stuck it all in hedge funds and now a bunch of them literally run actual hedge funds.

Ascension runs a hedge fund. They’ve got, depending who you believe, somewhere between 18 billion and 40 billion in their hedge fund. But even teeny guys are at it. There’s a hospital system in New Jersey called RWJ Barnabas. It’s around a 20 hospital system, with about $6 billion in revenue, and more than $2.5 billion in investments. I went and looked at their 990 (the tax form non-profits have to file). In a system like that–not a big player in the national scheme–how many people would you guess make more than a million dollars a year?

They actually put it on their 990 and they hope no one reads it, and no one does. The answer is 28 people – and another 14 make more than $750K a year. I don’t know who the 28th person is but they must be doing really important stuff to be paid a million dollars a year. Their executive compensation is more than the payroll of the Oakland A’s.

On the one hand, you have these organizations which are professing to be the health system serving the community, with their mission statements and all the worthy people on their boards, and on the other they literally paying millions to their management teams.

Go look at any one of these small regional hospital systems. The 990s are stuffed with people who, if they’re not making a million, they’re making $750,000. The CEOs are all making $2m up to $10 million in some cases more. But it also goes down a long way. It’s like the 1980s scene with Michael Douglas as Gordon Gecko in Wall Street criticizing all the 35 vice presidents in whatever that company was all making $200K a year.

Meanwhile, these are the same organizations that appear in the news frequently for setting debt collectors onto their incredibly poor patients who owe them thousands or sometimes just hundreds of dollars. In one case ProPublica dug up it was their own employees who owed them for hospital bills they couldn’t pay and their employer was docking their wages — from $12 an hour employees.

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Too much fawning over Len Schaeffer?

By MATTHEW HOLT

There’s a lot of strum & dangst about the uptick in system utilization that has boosted hospital profits and hit Humana and United’s bottom line (But not so much Elevance’s). Kevin O’ Leary over at Health Tech Nerds brought this up today and I was reminded of this piece I wrote in 2006. And a big issue was, how much understanding and control do insurers have over the utilization in (and out of) their networks. So take a look at this piece and particularly, given the issues at the BUCAHs and at smaller players like Agilon, consider how much insurers actually know about spending? And remember that Wellpoint was the 1990s name for what is now Elevance, via being called Anthem!–Matthew Holt

No one is arguing that Len Schaeffer isn’t a very bright guy, nor that he hasn’t done very well in America’s health care system. He’s also done very well out of America’s health care system. So when McKinsey publishes a fawning interview with the man who saved Blue Cross of California, and turned it into one of the most profitable for-profit health insurance companies, and then merged it with the other for-profit Blues, it’s perhaps appropriate to ask a few more questions.

Full disclosure here; in the distant past I’ve worked for several companies that are now part of the Anthem/Wellpoint collosus; and I currently do work for the California Health Care Foundation, which wouldn’t exist were it not for the fact that, when Wellpoint converted to for-profit status, it (and the California Endowment) were endowed with a huge chunk of stock. So you can take my comments in what ever light you like. In addition I’ve only done limited research here and a couple of things are retelling of tales I’ve heard, so if anyone knows more gossip, please email me.

Schaeffer is coming towards the end of his business career, but he started young and fast. He was head of HCFA (the artist now known as CMS) at age 33 in the Carter Administration. Now I call Mark McClellan the boy wonder, but he was 41 when he got the job! After leaving HCFA (before it got really exciting in the early years of the Reagan administration when DRGs were introduced, but being the first to introduce a type of DRG for kidney dialysis), and going via Group Health for a couple of years, he ended up at Blue Cross of California. He got there in the middle of an incredible screw-up.

Blue Cross had set up an HMO to compete with Kaiser called HealthNet. Incredibly enough somehow or other Blue Cross didn’t manage to enforce their formal corporate control over its board members on the board of HealthNet. So the board of HealthNet looked around the room one day, noticed that they might do alright if they were running a for-profit company, and declared independence. More on that story in this court documents. And apparently despite several years in court there was nothing Blue Cross could do. Retroactively Healthnet had to agree to endow a foundation with the state (the California Wellness Foundation) but the amount put into that foundation was a tiny, tiny proportion of HealthNet’s market value.

Schaeffer turned up to steady the ship at Blue Cross in the wake of the Healthnet screwup. In part he did this by turning Blue Cross from a warm and fuzzy non-profit into a pretty avaricious underwriter and a health plan that played very hardball with its providers (and members). More on that in the first section of this document, but it’s a reminder of a tack taken years later by Jack Rowe at Aetna.

But he clearly learned something from the experience.  The first thing he did was to set up a for-profit subsidiary called Wellpoint which started buying health plans and offering services (primarily outside California). Then he tried to put all of Blue Cross’ assets into Wellpoint. It looked like he’d away with this for a while, but then started  negotiations to take the whole thing for-profit. Apparently when the state first asked him the amount with which he would fund the foundation, his first offer was “nothing”.  This eventually got anted-up to $100m. Eventually the state (pressured by consumers’ groups) pointed out that it had quite a bit of control over the Blue Cross plans, and in the end the two Foundations were set up with lots of money and the majority of the stock, which gets spent doing good works in California (and funding some great research!) — not that everyone’s happy with it!

However, what amuses and dismays me is that Schaeffer is lauded for a couple of things, specifically the creation of new insurance plans and the shift to consumer care, and a commitment to IT. I really don’t understand what is so amazing about the new consumer plans, other than the Tonik brand has a lame web sites which look exactly like what a 50 year old thinks a 23yr old thinks is cool.  THCB readers already know that, while selling high deductible plans to youngsters may help a 23 yr old who needs catastrophic insurance, you’re not going to fix the problem of uninsurance by replacing it with under-insurance. But underwritten properly, these plans are very profitable for Wellpoint. And Wellpoint is damn good at underwriting.

So much so that you’d be surprised at what Schaeffer says is the main problem with American health care. Practice variation and lack of information:

The level of variation in our health care system is unbelievable. You could be hospitalized for nine days in New York and for three days in California with the same diagnosis—and those differences would have no impact on outcomes. There is no other industry in the world that uses so many different approaches to the same thing and in which these differences don’t relate to better results

So can’t health plans fix that? Apparently not:

As a health insurer, if you start by telling doctors, “We know what’s best; we’ll pay you for it,” you violate the fundamental principle that doctors want to exercise their own discretion. That’s what killed HMOs—telling the doctors what to do. Doctors don’t like to follow cookbooks, but, clearly, evidence-based medicine would work better for patients.

So because health plans failed at getting doctors to practice better medicine, instead they’re going to give them the information systems that show the doctors all about this variation, and it’ll magically self-correct. Except there’s the odd problem there too, including more cluelessness by health plans.

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Who Could (Possibly) Be the Ideal “Chief Patient Officer”?  (And Other Ideas that Sound Better on Paper than in Practice)

By JONATHON S. FEIT

If ideas presented in essays on The Health Care Blog and other healthcare forums are meant to be rhetorical, without intention of turning notions into reality on behalf of patients who need genuine, intimate, desperate help…then feel free to ignore this essay entirely. 

Some among us—the State of Washington’s Co-Responder Outreach Alliance; Lisa Fitzpatrick’s Grapevine Health, which specializes in “street medicine” and advocacy in and around Washington, D.C.; Thorne Ambulance Service, an inspirational ambulance entrepreneur bringing both emergency and nonemergency medical transportation to underserved rural spaces (and more) across South Carolina; and the RightCare Foundation in Phoenix, a firefighter-driven organization dedicated to ensuring that patients’ needs and wishes are honored during critical moments, spring fast to mind—are stretching hands across the care continuum while pounding the table for interoperability at scale because PEOPLE. ARE. FALLING. THROUGH. THE. CRACKS. AND. DYING.  

Thatincludes responders who run toward the crises; into alleys; who risk their own lives, health, psyches, families, and futures because, as Josh Nultemeier—Chief Paramedic and Operations Manager of San Francisco’s King-American Ambulance, and a volunteer firefighter in the Town of Forestville—put it so simply in a social media post: “People could get hurt.” Moral override—that matter-of-fact willingness to risk himself for strangers who lack any other path to save themselves—is what makes Josh (and others who believe as he does) heroic.

Solving problems like substance use disorder—coupled with an increasing awareness of the lack of interoperability with prescription drug monitoring programs (PDMPs), many of which are run by Bamboo Health, which today imports zero data regarding out-of-hospital overdoses—is urgent. If an overdose is reversed in an alley, an abandoned home, a tent or “under the bridge downtown,” by an ambulance, fire, or police service pumping Narcan to get breathing going again, the agency’s lifesaving efforts get zero “credit” in the data. The downstream effects of this information sharing breakdown make it difficult to settle for less-than-bona fide interoperability: there is neither time to waste nor margin of error, yet hospitals and healthcare systems cannot even “see” the tip-of-the-tip-of-the-spear.

A similar emotionality makes it difficult to tolerate lamentations about information sharing when states like California—and the federal Office of EMS, inside the National Highway Traffic Safety Administration—are transforming interoperability into a standard operating procedure. As a listener to the “Health Tech Talk Show” since its start, I have struggled with hearing Lisa Bari and Kat McDavitt deride whether interoperability is “real.” It is real. It is happening, and has been automated for years—for example, with both the Quality Health Network and Contexture (formerly CORHIO) in Colorado—empowering agencies of all sizes to care for patients experiencing healthcare emergencies, and those who have children with Duchenne’s Muscular Dystrophy and other diseases. Such efforts should be celebrated for their meaningful impact on patients who rely on ambulance services to get them the care that they need—and sometimes to get them to the care that they need. 

Yet no panel at the national conference for CIVITAS was dedicated to interoperability to or from ambulances, despite that some of America’s most active health information exchanges—coast to coast—have automated interoperability involving Fire, EMS, Non-Emergency / Interfacility Medical Transport, Critical Care, and Community Paramedicine. No mention highlighted widespread efforts to make POLST forms accessible to Mobile Medical professionals, thanks to prioritization of the ethical treatment of medically frail patients after COVID-19 and a New York Times piece called “Filing Suit for Wrongful Life.”

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Zombie Viruses of the Permafrost

By KIM BELLARD

We’ve had some cold weather here lately, as has much of the nation. Not necessarily record-breaking, but uncomfortable for millions of people. It’s the kind of weather that causes climate change skeptics to sneer “where’s the global warming now?” This despite 2023 being the warmest year on record — “by far” — and the fact that the ten warmest years since 1850 have all been in the last decade, according to NOAA.

One of the parts of the globe warming the fastest is the Arctic, which is warming four times as fast as the rest of the planet. That sounds like good news if you run a shipping company looking for shorter routes (or to avoid the troubled Red Sea area), but may be bad news for everyone else.  If you don’t know why, I have two words for you: zombie viruses.

Most people are at least vaguely aware of permafrost, which covers vast portions of Siberia, Alaska, and Canada. Historically, it’s been literally frozen, not just seasonally but for years, decades, centuries, millennia, or even longer. Well, it’s starting to thaw.

Now, maybe its kind of cool that we’re finding bodies of extinct species like the woolly mammoth (which some geniuses want to revive). But also buried in the permafrost are lots of microorganisms, many of which are not, in fact, dead but are in kind of a statis. As geneticist Jean-Michel Claverie of Aix-Marseille University, recently explained to The Observer: “The crucial point about permafrost is that it is cold, dark and lacks oxygen, which is perfect for preserving biological material. You could put a yoghurt in permafrost and it might still be edible 50,000 years later.”

Dr. Claverie and his team first revived such a virus – some 30,000 years old — in 2014 and last year did the same for some that were 48,000 years old. There are believed to be organisms that ae perhaps a million years old, far older than we’ve been around. Scientists prefer to call them Methuselah microbes, although “zombie viruses” is more likely to get people’s attention.

He’s worried about the risks they pose.

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Au Contraire

By KIM BELLARD

Last week HHS announced the appointment of its first Chief Competition Officer. I probably would have normally skipped it, except that also last week, writing in The Health Care Blog, Kat McDavitt and Lisa Bari called for HHS to name a Chief Patient Officer. I’ll touch on each of those shortly, but it made me think about all the Chiefs healthcare is getting, such as Chief Innovation Officer or Chief Customer Experience Officer.  

But what healthcare may need even more than those is a Chief Contrarian. 

The new HHS role “is responsible for coordinating, identifying, and elevating opportunities across the Department to promote competition in health care markets,” and “will play a leading role in working with the Federal Trade Commission and Department of Justice to address concentration in health care markets through data-sharing, reciprocal training programs, and the further development of additional health care competition policy initiatives.” All good stuff, to be sure.

Similarly., Ms. McDevitt and Ms, Bari point out that large healthcare organizations have the staff, time, and financial resources to ensure their points of view are heard by HHS and the rest of the federal government, whereas: “Patients do not have the resources to hire lobbyists or high-profile legal teams, nor do they have a large and well-funded trade association to represent their interests.” They go on to lament: “Because of this lack of access, resources, and representation, and because there is no single senior staff member in the federal government dedicated to ensuring the voice of the patient is represented, the needs and experiences of patients are deprioritized by corporate interests.” Thus the need for a Chief Patient Officer. Again, bravo.

The need for a Chief Contrarian – and not just at HHS – came to me from an article in The Conversation by Dana Brakman Reiser, a Professor of Law at Brooklyn Law School. She and colleague Claire Hill, a University of Minnesota law professor, argue that non-profit boards need to have “designated contrarians.”

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25th Amendment Still Not the Right Response to a Mentally Ill Trump

By MIKE MAGEE

On May 16, 2017 New York Times conservative columnist, Russ Douthat, wrote “The 25th Amendment Solution for Removing Trump.” 

That column was the starting point for a Spring course I taught on the 25th Amendment at the President’s College in Hartford, CT. I will not summarize the entire course here, but would like to emphasize four points:

  1. The American public was adequately warned (now 7 years ago) of the risk that Trump represented to our nation and our democracy.
  2. Douthat’s piece triggered a journalistic debate which I summarize below with four slides drawn from my lectures.
  3. Had Pence and the cabinet chosen to activate the 25th Amendment, as it is written, Trump would have had the right to appeal “his inability”, forcing the Congress to decide whether there was cause to remove the President.
  4. Judging from the later impeachment of Trump in the House, but failure to convict in the Senate, it is unlikely a courageous Pence and Cabinet would have been backed by their own party.

Let’s look at four archived slides from the 2017 lecture, and then discuss our current options in the case of 2024 Trump against Democracy. 

Slide 1. Russ Douthat

        Slide 2. Jamal Greene (in response)

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The US needs a Chief Patient Officer

By KAT McDAVITT and LISA BARI

Regulations are created by well-intentioned government employees who, understandably, focus on the loudest voices they hear. The loudest voices tend to be from organizations — vendors, associations, large corporations — that have the internal and external resources needed to access the federal government, navigate the 80,000-employee Department of Health and Human Services (HHS), and ensure that the perspectives of their employers and members are heard.

Patients do not have the resources to hire lobbyists or high-profile legal teams, nor do they have a large and well-funded trade association to represent their interests. Traditional patient advocacy organizations, while generally well intentioned, are often structured around specific conditions and often are financially supported by pharmaceutical and biotech companies. Because of this lack of access, resources, and representation, and because there is no single senior staff member in the federal government dedicated to ensuring the voice of the patient is represented, the needs and experiences of patients are deprioritized by corporate interests. As noted by Grace Cordovano, PhD, BCPA, a board-certified patient advocate, while speaking during a 2023 Health Datapalooza session on transparency and trust, “We hear a lot about provider burnout, but patients are also burnt out, and we need to take that into consideration when developing our policies.”

Policy implementation matters—and implementation is where patient interests fall through the cracks

Meaningful Use, a part of the HITECH Act within the American Recovery & Reinvestment Act, was well intentioned: Get records digitized for better care coordination.

But implementation and execution matters. Each stage of the $35 billion-plus Electronic Health Record (EHR) Incentive Programs, which evolved into the Promoting Interoperability Programs, was increasingly complex. Pieced together through administrative rulemaking, the program was eroded, mainly by corporate interests, and resulted in clinicians having less time for face-to-face patient interaction. Certified EHR requirements were driven by the most prominent vendors in an objectively fantastic demonstration of regulatory capture. Today, most provider offices use an electronic health record, but patients still do not have seamless access to their complete records. Although we are seeing improvements in interoperability, patients need more than access; they need to be able to act using insights from their health data.

Another example of corporate interests overtaking better outcomes for patients can be seen in the implementation of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018, which required states to establish a qualified prescription drug monitoring program (PDMP). A single vendor runs the PDMP in more than 46 states and territories. Thus, instead of sharing protected information with other health data organizations, like health information exchanges, these systems silo it. Many states mandate that that physicians check their state PDMP system separately and then charge those physicians a fee for mandatory access. Instead of helping to coordinate the care of a patient who may be struggling with an opioid use disorder, vendors have used a fear-based regulatory capture strategy at the federal and state levels to ensure these systems are separate from other health data—preserving market share and raising the barrier to entry for new competitive solutions.

Often, patients have no idea what data a PDMP has on them — which, in some states, can include opioids prescribed to pets under their name — and are unable to access it on their own. They also have no way to correct wrong information. Who suffers here? Patients, families, and the physicians who coordinate their care.

The Trusted Exchange Framework and Common Agreement (TEFCA), a part of the 21st Century Cures Act, is also well intentioned. One of the framework’s most significant promises was that, despite leveraging inferior data transfer standards, it would provide a uniform way for patients to request their records at no charge to them. In practice, after multiple delays, false starts, and many rounds of public notice and comment, TEFCA has launched without the requirement that its qualified health information networks (QHINs) and their participants must provide individual access services to patients for their own records.

The regulatory capture strategies of several QHINs and QHIN candidates have been textbook-worthy, ensuring those who have the resources to dominate the market will be locked in. What isn’t locked in? Any mandated access for patients, who were the audience most likely to benefit from TEFCA.

Will individual access services be reinforced in subsequent TEFCA requirements? Maybe, if someone within HHS — like an objective chief patient officer —is fighting for them like their mission and job depends on it.

A step toward progress

Patients, especially our country’s most vulnerable, underserved, and those suffering from financial toxicity, will never be able to afford the lobbying resources and access that corporations and large trade associations have. Consequently, our system will continue to be built to appease the private sector and to put finances over progress. That is, unless we start to ensure the patient voice is heard by creating a senior position within HHS dedicated to improving the experience and lives of 340 million Americans.

Kat McDavitt is president of Innsena and CEO of the Zorya Foundation. Lisa Bari is CEO of Civitas Networks for Health.

A Speech For The Ages – 83 Years Ago This Christmas

By MIKE MAGEE

On the evening of December 29, 1940, with election to his 3rd term as President secured, FDR delivered these words as part of his sixteenth “Fireside Chat”: “There can be no appeasement with ruthlessness…No man can tame a tiger into a kitten by stroking it.”

Millions of Americans, and millions of Britains were tuned in that evening, as President Roosevelt made clear where he stood while carefully avoiding over-stepping his authority in a nation still in the grips of a combative and isolationist opposition party.

That very evening, the Germans Luftwaffe, launched their largest yet raid on the financial district of London. Their “fire starter” group, KGr 100, initiated the attack with incendiary bombs that triggered fifteen hundred fires that began a conflagration ending in what some labeled the The Second Great Fire of London. Less than a year later, on the eve of another Christmas, we would be drawn into the war with the bombing of Pearl Harbor.

Now, 83 Christmases later, with warnings of “poisoning the blood of our people,” we find ourselves contending with our own Hitler here at home.  Trump is busy igniting white supremacist fires utilizing the same vocabulary and challenging the boundaries of decency, safety and civility. What has the rest of the civilized world learned in the meantime?

First, appeasement does not work. It expands the vulnerability of a majority suffering the “tyranny of the minority.”

Second, the radicalized minority will utilize any weapon available, without constraint, to maintain and expand their power.

Third, the battle to save and preserve democracy in these modern times is never fully won. We remain in the early years of this deadly serious conflict, awakened from a self-induced slumber on January 6, 2020.

Hitler was no more an “evil genius” than is Trump. But both advantaged historic and cultural biases and grievances, leveraging them and magnifying them with deliberate lies and media manipulation. Cultures made sick by racism, systemic inequality, hopelessness, patriarchy, and violence, clearly can be harnessed for great harm. But it doesn’t take a “genius.” Churchill never called Hitler a “genius.” Most often he only referred to him as “that bad man.”

The spectacle and emergence of Kevin McCarthy, followed by Mike Johnson, as Speaker of the House, and the contrasting address by House Minority Leader Hakeem Jeffries as he handed over the gavel, represent just one more skirmish in this “War for Democracy.” 

If our goal is a “healthier” America – one marked by compassion, understanding and partnership; one where fear and worry are counter-acted by touch and comfort; one where linkages between individuals, families, communities and societies are constructed to last – all signals confirm that the time is now to fight with vigor.

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