Medical errors should not be prosecuted as crimes: Systemic change is needed

As reported recently in MedPage Today, Kentucky has become the first state to pass a law shielding medical professionals from criminal prosecution for clinical errors. This is important. It is a good thing and had the support of many professional organizations. It is not about protecting nurses and doctors who actually commit crimes, as ‘it does not apply to "gross negligence or wanton, willful, malicious, or intentional misconduct."’ For example, the Pennsylvania nurse convicted of murdering patients with insulin would not be covered by this law. But mistakes happen, and while they can have very bad outcomes in the medical setting – including death – when they are not intentional they should not be prosecuted as criminal acts.

The case cited as motivating this law occurred in the neighboring state of Tennessee, and involved a nurse named RaDonda Vaught at Vanderbilt Medical Center. She mistakenly gave a paralytic rather than a sedative with a similar name to a 75 year old woman, causing her death. She did not try to cover it up but reported it immediately, and yet was charged with and convicted of reckless homicide and impaired adult abuse. The outcome, the woman’s death, was terrible, but the criminal charges were neither justified nor functional. Yes, you can bet that the particular nurse would be extra careful the next time she gives medication – although, of course, with the criminal conviction she has lost her nursing license. Maybe it could be a deterrent to other nurses and doctors making inadvertent mistakes? Think about how well this works in other areas, about, for example, how a pedestrian or bicyclist being killed by a car in your town has suddenly made all the other drivers extra careful. Right.

Doctors, nurses, and other health professionals are already careful (barring the rare truly malicious exception, who is not covered by this law). The issue is how to make it increasingly difficult to make mistakes, to make errors. A whole field of health safety and error prevention exists, originally stimulated by the work of W. Edwards Deming and Avedis Donabedian, and including such luminaries as the Institute for Healthcare Improvement (IHI) and founders Donald Berwick and Paul Batalden, and Harvard professor Gordon Schiff.  One thing that is clear is that the solution is not draconian punishment of those who have made mistakes. It is mostly (almost all) about systems, about making it difficult (and some day, hopefully impossible) to commit errors. Deming said “To find the mistake is not enough. It is necessary to find the cause behind the mistake, and to build a system that minimizes future mistakes”. Every mistake is a gem, because it offers us the opportunity to discover the cause and to develop systems to prevent that, and similar, mistakes in the future.

Many systems have been developed in many places and areas of healthcare to do this. For example, in pharmacy drug lists, similar sounding or spelled drugs are often distinguished by having the letters that are different capitalized, calling attention to it and making it less likely to prescribe the wrong one. Surgery now almost never takes place without a final “timeout” in which a checklist is gone through with all the operating team present, including “which side are we operating on”! There are many more examples. In the field of occupational health, the first choice in preventing injuries is architectural, e.g., don’t put a big window next to a place on the shop floor where slippery substances are spilled. The second choice is engineering: ok, the window is there, so let’s put up bars across it so if people do slip they don’t go through. The last choice is behavioral: tell the people who work there to be careful! If this last sounds unlikely to be completely successful, it is both the most common and the least effective. Imagine your being responsible for changing the behavior, consistently and always, of a person. Now make that everyone! Think back to drivers…

It is true that many, maybe most, healthcare facilities are and have been working to improve quality and limit the number of possible places that workers can make mistakes, but these procedures are processes and must continually be upgraded and enhanced, primarily by identifying mistakes that continue to be made and figuring out how they can be prevented. Quality improvement is not something that can be “put in place”; it is both a state of mind of individuals and most importantly an overarching commitment on the part of the institution, in all places. Yes, it costs money – but so do the lawsuits that come when it is inadequate, and that should not be the motivation.

Although making money is a strong motivation. Insurance companies, for example, are very good at instituting procedures that make them money. ProPublica recently published an article about Dr. Debby Day, who was one of the physician reviewers at CIGNA, tasked with reviewing the decisions about approving or denying coverage for people’s care, after the initial decision was made by a nurse reviewer (mostly working in the Philippines). CIGNA continually monitored the number of minutes taken for each review, and physicians like Dr. Day were sanctioned or even fired if they took too long. They took too long making decisions that could not only affect people’s health, but their life and death. Your life and death. Your family’s. How were they supposed to keep up with the speedup expectations? ‘“Deny, deny, deny. That’s how you hit your numbers,” said Day, “If you take a breath or think about any of these cases, you’re going to fall behind.”’ This makes CIGNA (and, to be fair ALL the big health insurance companies) money. The speedup is part of it, but the denials are where the real money is made. Denying ‘coverage for a cancer patient or a sick baby’. Your cancer. Your baby.

To be sure, insurance companies as such are not the actual providers of health care, like hospitals and doctors. Except, increasingly through vertical integration, they are – UnitedHealth, for example, owns Optum (and OptumRx, a pharmacy benefits manager). The thing is that they are corporations and are very good at putting systems in place to increase their bottom-line profits, even when that harms the health of – or kills – people who are their clients. So, I think, they should and can be equally effective in putting in place systems that protect and benefit those clients/customers/patients/people.

Hopefully, the type of law passed in Kentucky will become more widespread. This will make it more difficult for the prosecutors and politicians who want to make their “tough on crime” reps by such prosecutions, which is good. But also, hopefully, it will be combined with renewed efforts to strengthen the systems of quality control, and greatly limit the possibility of an individual making a mistake.

The health of people should be the goal of healthcare organizations.

Medicare Scams? The whole US health care "system" is a scam!

In ‘Staggering Rise in Catheter Bills Suggests Medicare Scam’, Feb 9, 2024, the NY Times suggests that up to 20% of federal spending on medical supplies may be from 7 “high-volume” suppliers of catheters, including people -- like the woman for whom Medicare paid $12,000 for 2000 catheters -- who don’t need them, don’t want them, did not order them, and didn’t receive them. If true, this is a totally illegal scam, something that we see all too frequently in the US, with criminal parasites preying on our people and on a federal agency hamstrung by budget cuts to their enforcement divisions. Perhaps “nursing homes” is what first comes to the minds of many when inflated billing for shoddy care comes to mind, and that is fair, but our medical supply companies and, of course, pharmaceutical companies are right there with scams.

Unfortunately, the biggest scam is not the obviously-illegal like catheter falsifying, but rather the skirting-the-law routine practice of many (maybe not all) health insurance companies in denying necessary, and sometimes legally-required, care to their clients. The most common method for doing so is requiring “prior authorization” and then repeatedly denying it until the client gets weary of fighting it, or recovers, or, maybe, dies from not having a procedure. And it is not like these denials are wisely made by qualified physicians sagely considering the issue; most of them are routinely denied by staff (sometimes, but not always, nurses) following algorithms. Or, increasingly, by AI.

I and others (e.g., https://wendellpotter.substack.com/p/the-great-medicare-advantage-marketing) have written about Medicare Advantage plans several times, which attract seniors with lower out-of-pocket costs (compared to paying for Medicare Part B + a supplement) and full coverage, including for some services not covered by Medicare (glasses, hearing aids, etc.) My main point has been that this is great if you are willing to use their limited network of doctors and hospitals -- until it isn’t. Until they deny you care. Which can be illegal because they are required by law to cover everything Medicare covers. But, using the “prior authorization” and “repeated denials” techniques, many (maybe not all) often (but not always) do. This is just as illegal as the catheter scam, but penalties have been rarely incurred, and when they are, are low enough to be considered a “cost of doing business”, essentially a slap on the wrist.

But it is not only Medicare Advantage (MA) that uses these techniques (I’ll call them PA&RD) to effectively deny care to the people who are paying their premiums. Indeed, the use of these strategies in MA plans was developed for the insurance companies’ non-Medicare clients, those who have coverage through employer-based plans or ACA. For a long time, the use of PA&RD was common, if not ubiquitous, but possibly legal. Unethical, maybe. Fatal for some, yes. But apparently legal. Some state legislatures stepped in to prevent these abuses, requiring coverage for certain conditions, such as diabetes, emergency care or reconstructive surgery for breast cancer. Indeed, ‘States have passed hundreds of laws to protect people from wrongful insurance denials’, but as documented by ProPublica, ‘Health Insurers Have Been Breaking State Laws for Years’. How do they get away with it? Again, lack of enforcers because of budget cuts and very powerful lobbies for the insurers (they make lots of money and are careful to spend enough of it in the “right” places!) Per ProPublica:

State insurance departments are responsible for enforcing these laws, but many are ill-equipped to do so, researchers, consumer advocates and even some regulators say. These agencies oversee all types of insurance, including plans covering cars, homes and people’s health. Yet they employed less people last year than they did a decade ago. Their first priority is making sure plans remain solvent; protecting consumers from unlawful denials often takes a backseat.

What are the results? One is that people stay sick, get worse, and sometimes die from lack of health care. I hope we can agree that is a bad thing. Another is that people are going broke more and more often from trying to pay the bills that their insurance companies don’t (yes, those insurance companies that they and/or their employers have been paying premiums to). The recent study by KFF Health News and NPR, reported in the Guardian and the Health Justice Monitor and discussed by me recently (ER backups and poor-quality but expensive insurance: The American Way!, Jan 24, 2024), but worth repeating, found that more than 100 million Americans have medical debt. More shockingly, (as reported by Kodiak Solutions, a billing and accounting firm that covers 1800, nearly 1/3 of US hospitals) in just 4 short years the proportion of that debt owed by insured people has risen from 11% to 58%! Think about that – way back in 2018 most “bad debt” was owed by uninsured people (almost all of whom were too low-income to be able to afford it) but by 2022 it was by insured people – meaning insurance companies were not doing what they were contracted to do – paying people’s medical bills – even when required to by state law.

When the bad actions of health insurance companies are combined with the bad actions of health care providers, now often owned by private equity companies seeking only profit (see example of Steward Health Care, or overcrowded ERs in Massachusetts, as well as Arizona) it is obvious that get real pain being is being suffered by – really, inflicted upon -- the American people. On the other hand, insurers like UnitedHealth (which also operates the largest chain of physician practices, Optum), and private equity companies like that which owns Steward Health Care, are doing just fine, thank you, making record profits.  And the drug companies finding all the loopholes in laws to charge more and telling Sen. Sanders and the health committee that sure they charge American consumers more for drugs, but, hey, why the heck not, since we’re allowed to here – and, by the way, don’t change that – are continuing, as they always have, to make out like, well, bandits, which they have always been. They argued to the Senate that Americans get access to new drugs first as part of paying more, but Sen. Sanders appropriately responded that this was of no help to people who were unable to get the drugs because of their cost! Duh!

There are those who think that the money we pay – in premiums, taxes, co-pays, etc. – should be spent on delivering health care, not corporate profits. But so far enough politicians have been willfully deaf and blind on the issue to prevent really significant change to the system so that (as in most countries) it does the latter.

They need to hear from you to tell them that’s what matters.

The insurance company mafia and Medicare Advantage: Taking your money and denying you care

If the government were considering ways of making small businesses function more effectively to meet the needs of their customers and make a reasonable living for their owners, they would consider the stakeholders. Those might reasonably be the owners, the customers, and perhaps the suppliers. And, of course the gangsters who supplied “protection" to the owners – that is, protecting them from damage that might occur if the owners didn’t pay up.

Oh. You don’t think so? Why would we include the gangsters who just prey upon these businesses, drive up costs and thus probably prices, and threaten bodily harm to innocent people? Well, why not? After all, they have a stake in those businesses as well. If this seems like a ridiculous idea, consider the fact that we do it whenever we consider changes to our healthcare system in the United States. Except, in that case, it is the health insurance, a huge parasitic industry that preys on the health of the American people by sucking out billions in profit from funds intended to pay for our actual health care. We not only allow it, we encourage it!

The patchwork nature of health insurance coverage in the US is incredible. Many folks are coverage by policies held by their employers, or the employers of family members, but the employer contribution has been decreasing with increases in what employees have to pay in premiums, co-pays, and co-insurance. Others are covered by government programs – indeed, when considering all of these including Medicare, Medicaid, military families and retirees, employees and families of federal, state, and local government – public funds are more than half our health expenditures, rising to about 60% if the taxes foregone by the government because (unlike wages) employer contributions but not employee contributions) to health insurance are tax free. And still others have insurance through the ACA (Obamacare) or actually pay their whole cost. And, of course, lots and lots of people are uninsured.

And the coverage for those who are insured varies tremendously, from plan to plan, insurer to insurer, employer to employer. Many policies are so bad that those who have them are almost as bad off as the uninsured – but they are paying for it. People get low-cost policies because this is what they can afford,  but pay the price when they find out they are sick. It is bad, bad, bad, inefficient, incredibly expensive, and, like all “protection” plans, beneficial only to the insurance company mafia. But it is even, in a way, more egregious when we consider how it has cannibalized Medicare, the federal program that is supposed to cover the aged, blind, and disabled. Not that it is ok to screw the younger, non-blind or disabled portion of our population, but Medicare, passed in 1965, was supposed to ensure health care for the elderly, who are, in fact, more likely to be sick.

But then we get “Medicare Advantage” (also known as Medicare Part C), pushed by successive Republican administrations and assented to by the Democrats who seem to believe the hype. Let’s be clear about what MA is and is not. It is NOT Medicare, the program funded by your Medicare taxes from your paycheck (Part A) or general revenue + you (Part B). It is private health insurance being paid for with Medicare dollars (and the MA insurers get more, per capita than Medicare itself). It is usually a PPO or HMO plan, which can (and does, its essential character) restrict the health care providers (doctors, hospitals, etc.) you can use, and can and does make it more difficult to get care by denying payment (illegal as such; it is supposed to cover, by law, everything Medicare does, but it can delay and delay by repeated denials) or requiring prior authorization for – everything. Sometimes until it is too late and you die. We’ll look at some examples.

In a piece subtly titled “Deny, deny, deny”, NBC News on Oct 31, 2023 describes how rural hospitals, usually the sole community provider, are losing so much money from MA plans denying their claims that they are either in danger of closing or at least will no longer accept MA. That, of course, creates major problems for their patients covered by MA plans – remember, they are not a problem until you get sick! ‘Rose Stone of Holly Springs, Miss., said she stopped going to her doctor after her Medicare Advantage plan wouldn't pay for the visits. “It was a mess,” Stone told NBC News. “I didn’t go to the doctor because I was going to have to pay out-of-pocket money I didn’t have.”’

The Washington Post, on Nov 29, 2023, in Hospitals and doctors are fed up with Medicare Advantage, discusses that they are not only fed up, but they are refusing to accept MA plans because it does not pay them for the services that they provide. Scripps Health in San Diego joined Mayo Clinic and many other facilities in not taking any MA plans. The problem with the article is it can be read to imply that doctors and hospitals are greedy, since ‘Medicare Advantage plans are pretty popular with both lawmakers and ordinary Americans — they now enroll about 31 million people, representing just over half of everyone in Medicare, by KFF’s (Kaiser Family  Foundation) count.’ Popular with lawmakers because, a lot, they are heavily lobbied by insurers and get campaign contributions from them. Popular with ordinary Americans in the same way that a lot of things are popular – they are heavily advertised and cheaper on the front end than having to buy a Medicare Supplement plan because Medicare only pays 80% of the money it approves for covered services. And they provide glasses, and dental, and often drugs without a separate Part D plan, and even gym memberships! Great! Until you really need care…like Ms. Stone.

Or like the woman who was denied coverage by Cigna for a lung transplant and died, as discussed by former insurance executive and current whistleblower Wendell Potter in his substack, “Health Care Un-Covered”, on Nov 27, 2023. Or the reports of massive denials, including those that break the law, identified by ProPublica in partnership with Scripps News and reported by Potter on Nov 30, 2023. These are not isolated stories; they occur all the time.

Potter also testified in favor of retirees from Cortland County,  NY, when the county was trying to push them all into an MA plan run by UnitedHealth. For this year, at least, they were successful, arguing basically about how Prior Authorizations (PAs) required by UnitedHealth would limit their care. At the last minute, under discovery, they obtained a (possibly incomplete) list of services requiring PA…essentially everything (see the list at the end of this post)! And if anyone is worried that these doctors and hospitals wanting to be paid for the work that they actually do for people’s health (remember – insurance companies do ZERO of this!) will bankrupt the MA plans, we can look at their profits. In a piece Potter wrote looking at how Cigna is trying to acquire Humana to get a piece of the MA market he provides the profit made by the largest players in the industry: Cigna $7.28B on revenues of $181B, Humana $4.2B on revenues of $93B, and industry leader UnitedHealth $28.4B on revenues of $324B – nearly 9%! ALL of this is on money that was intended to be spent on providing health care to Medicare recipients! No wonder they can pay for your gym membership! They sure ain’t hurting!

Other countries have much less complex and arcane coverage systems. You’re born, you’re covered. Everyone is in, no one is out. Pretty much everyone is in the same plan. That is what we could have if we had an expanded (to everyone) and improved (covering 100%, not 80%, of ALL necessary services, including mental health, dental, vision, hearing, drugs, long-term care) Medicare for All.

But the insurance company mafia stands in the way. Contact your senators and congresspeople! 

    From Wendell Potter, list of services (possibly incomplete) requiring PA from UnitedHealth:

The list includes:

• Cardiac rehabilitation services
• Intensive cardiac rehabilitation services
• Chiropractic services
• Outpatient diagnostic colonoscopy
• Supplies to monitor blood glucose
• Continuous glucose monitors
• Therapeutic shoes for people with diabetes
• Durable medical equipment
• Diagnostic hearing and balance evaluations
• Home infusion therapy
• Inpatient services in a psychiatric hospital
• Medicare Part B drugs and non-chemotherapy drugs to treat cancer
• Medicare-covered chemotherapy drugs to treat cancer and the administration of that drug
• Opioid treatment services
• Outpatient diagnostic tests and therapeutic services and supplies, including x-rays and other radiation therapies
• Lab tests and other diagnostic tests
• Outpatient mental health care
• Outpatient rehabilitation services
• Outpatient substance abuse services
• Outpatient surgery and other medical services at hospital outpatient and ambulatory surgical centers
• Partial hospitalization services and intensive outpatient services
• Basic hearing and balance exams
• Some telehealth services
• Second opinions prior to surgery
• Non-routine dental care
• Monitoring services in a physician’s office or outpatient setting
• Medically necessary medical and surgical services that are provided at home or nursing home
• Prosthetic devices
• Pulmonary rehabilitation services
• Skilled nursing care
• Supervised exercise therapy
• Outpatient services provided by an ophthalmologist or optometrist
• Eye exams for people with diabetes