On 4/18/22, a federal judge in Florida struck down the CDC requirement of wearing masks on trains, planes on domestic flights, and other public transportation. This came less than a week after the Centers for Disease Control extended the mask mandate through 5/3/22. Immediately a number of airlines, including Delta and Alaska, announced that they were removing the requirement.
She made this ruling before a hearing was held, and nationalized the ruling rather than limiting it to the plaintiffs who had filed the case. In addition the mandate was probably going to go away in 2 weeks in any case.
Who was this federal judge? It was Kathryn Kimball Mizelle, appointed for a lifetime position at the age of 33 by President Trump, despite that she had never tried a case, and the American Bar Association rated her as, “Not Qualified.”
Just because she had the power to make this ruling, doesn’t mean she’s right. Of course when it comes to the law, I’m even less qualified than this judge, but from a medical point of view, we’re still in a pandemic. I, for one, will continue to wear a mask in an airplane, at least for a while, even if it’s just to avoid the common cold.
Big changes are coming to patients ability to see their medical information.
Starting this month, federal rules will require that all laboratory tests, including pathology reports, imaging, and progress notes be immediately released to patients, with rare exceptions. In March of 2020 the Office of the National Coordinator for Health Information Technology published the “21st Century Cures Act” final rule that requires providers and others to not engage in, “information blocking” by interfering with the use of electronic health information. The idea of patients being able to readily see their charts is known as Open Notes.
Traditionally doctors (and nurse practitioners) notes were considered to be their property. They were paper charts, and if they sold their practice, the chart would go with it. Although they would send copies to other treating physicians, they wouldn’t necessarily give patients a copy if they requested, and they might charge copying costs.
Although ownership status legally varies by state, and is ambiguous and debated in a number of places, in practice nowadays, usually the actual chart, whether it’s paper or electronic, is considered to belong to the physician/practice, but the information belongs to the patient. That information is not always readily available to patients, particularly notes. In the case of test results, even when available through patient portals, there is often a delay. For better or worse, this will be mostly going away.
On the positive side, overlooked abnormal tests are more likely to be caught by patients, they will be able to see their results sooner, and they may better understand their condition and expectations by reading the notes about their visits.
On the negative side, there are all kinds of things that can go wrong. Let’s start with test results. At my institution we’ve had a delay set for tests, with different delays depending on the test. Over time we’ve shorted the time on many of them as we became comfortable with the process. For example, things such as blood counts and chemistry tests (kidney function, cholesterol, etc) would get released shortly after midnight. Other tests, such as pathology tests, have been delayed 14 days. That gives the person who ordered it a chance to contact the patient before they see the results online.
As a patient, would you prefer to find out that you have cancer by having your physician or nurse practitioner call you, or talk to you when you come in for an appointment, or to find out online without putting the information in context (“You’ve got mail!”)?
In some cases physicians can warn patients to get them prepared, such as informing them that although they think a breast lump is probably benign, it may turn out to be cancer, and tell them what will happen if that’s the case. But besides that they may not have time to always do this, some times the results are unexpected. For example, someone may have no symptoms but they get a routine chest x-ray to make sure it’s alright before they undergo certain surgical procedures. It could show signs indicating probable metastatic cancer, and the report that comes back to them electronically may be how they find out.
As a physician I worry about getting overwhelmed by patient requests for information regarding tests they’ve seen online. Already many ask about abnormalities that are not clinically significant, such as a low LDL cholesterol or a high HDL (both of which are generally good). I often say that abnormal doesn’t mean good or bad, just that it’s outside the normal range. I’ve had several patients starting taking calcium as a results of misinterpreting a report when they saw a low “LDL (calc)” not realizing that “calc” is just an abbreviation of calculated, and not calcium.
Patients being able to read progress notes causes even more anxiety. Even though patients already can request copies of their records, in most cases they don’t. If we do get a request we have a chance to contact them if we’re concerned about something they may read.
Besides the concern that questions will generate more work for me, I worry more about patients misinterpreting the notes. When someone comes in with various symptoms, physicians come up with a differential diagnosis, meaning the different things that might cause those symptoms. For example, if someone has a cough, it could be bronchitis, pneumonia, asthma, reactive airway disease due to reflux (heartburn), or lung cancer, among other possibilities. Those possibilities are often included in the note for several reasons. It helps the writer organize their thoughts, and reminds them what they were thinking if they (or someone else) later looks back at the note. It also provides protection against malpractice lawsuits. It’s less egregious to treat lung cancer with an antibiotic if you write that you think it’s unlikely that the patient has cancer and more likely it’s just bronchitis. Many things we may include on our differential are rare, but patients may worry if they read them.
Another concern I have about notes is information that patients may find embarrassing or otherwise uncomfortable. It may include information pertaining to domestic violence, drug use, or sexual function. Although the new law allows one to not release a particular note, it’s expected that it will be used minimally, and there are significant penalties for doing so unless you can justify that it would cause significant patient harm. I think this will lead people to modify how they write their notes, sometimes resulting in notes that are less useful for those writing them. Doctors and other providers can learn to write notes in ways that patients will better accept, but it will take practice, and won’t always be possible. Unfortunately it’s not clear if the law is retroactive, so even notes written 20 years ago may be available to be read, though currently my institution won’t do that, though the legal advice went back and forth on it (thanks, Congress, for making that perfectly clear!).
Many physicians and other medical providers who have already voluntarily gone to automatically sharing their notes have said that most people find out that despite their fears, in practice it has not been an issue. I hope that’s the case.
Hidden in a 700-page draft regulation to improve patient’s access to their electronic medical records is a proposal to require doctors, hospitals, and other healthcare providers to publicly reveal the prices they have negotiated with insurers. This rule, tied to the 21st Century Cures Act, would set the stage for eventually making prices publicly available. Although price transparency may be a good way to help lower medical costs, it’s ironic that there is a lack of transparency when it comes to the proposed rule. I challenge you to read the Title, Summary, or Actions section and realize that it includes such a major change (hint – in the PDF document it’s on page 7513 of the Federal Register under Price Information).
On the face of it, making prices readily available sounds like a no-brainer, but I think it’s more complicated than that, and there may be unforeseen consequences. The rule is long and complex, and I don’t have the few days it would probably take me to really understand it, but let me play devil’s advocate. Some of the comments posted say that medicine is the only industry that hides the cost. To a certain extent that’s true, but this rule could go beyond just saying the price consumers pay. If you go to a restaurant they won’t reveal how much they paid for the the ingredients. If you book through a 3rd party website, they don’t tell you how much, if any, they pay them for the referral. When you buy a car the dealer usually doesn’t tell you if the automobile manufacturer is giving them a rebate. From the point of view of a business, the consumer shouldn’t get to know their internal costs as that’s secret competitive information.
What mitigates that argument is that the price of healthcare has gotten out of control. Despite being better educated about the matter than most, when it comes to getting healthcare for their own family I suspect most physicians struggle to understand their bills just like everyone else.
When it comes to pay, doctors are a commodity. For a given surgical procedure or office visit of a certain complexity, they are paid the same amount as mandated by Medicare or Medicaid, as negotiated with insurance companies, or their list price for the unfortunate cash patient. Just like any profession, some doctors are better than others. If you want to hire a top lawyer or an A list actor, you have to pay top dollar. But that’s not so with much of healthcare. The price doesn’t necessarily reflect the quality of the care.
Hospital systems mitigate that somewhat. They can negotiate higher prices with insurance companies and with large employers by demonstrating that they provide higher quality care and/or lower cost care, or because patient perceive them as providing superior care and they demand that that can get care from them. What will happen if the rule goes into affect and patients can easily compare prices? I don’t know, but potentially they might choose the lowest cost without regard to quality. That could lead to systems competing on price, cutting corners to do so, and ultimately lowering quality.
The lowest price might actually not be the path to cost savings. Imagine two surgeons. One of them charges $5,000 for a knee replacement, and operates on 60% of the patients seen for knee arthritis, treating the rest successfully with injections and physical therapy, which on average costs $1,000. The other charges $7,000, and operates on 50% of the patients seen and treats the rest successfully with the same conservative measures. Besides the physician fee, the hospital system charges $10,000 for the surgery. In this example, treating 100 patients would cost $940,000 for the first surgeon, and $900,000 for second. So even though the second surgeon charges 40% more than the first, on average the doctor ends up being cheaper when it comes to managing knee arthritis.
I’m inclined to support more transparency in healthcare pricing, but I don’t know how much of an impact it will have, and there may be unintended consequences.
Don’t expect to see published prices anytime soon. Even if the proposal goes forward, following a public comment period that ends May 3, it’s likely to be tied up in legal challenges for quite a while.
Patients are often encouraged to make wishes known with a living will or other instrument. If someone says they would not want resuscitation if their heart stopped, they are said to be DNR, as in Do Not Resuscitate, or more accurately DNAR, Do Not Attempt Resuscitation. Success rates one month after out of hospital cardiac arrests when CPR is performed are only about 4.9% to 9.2%.
“(a) If at any time I should be diagnosed in writing to be in a terminal condition by the attending physician, or in a permanent unconscious condition by two physicians, and where the application of life-sustaining treatment would serve only to artificially prolong the process of my dying, I direct that such treatment be withheld or withdrawn, and that I be permitted to die naturally. I understand by using this form that a terminal condition means an incurable and irreversible condition caused by injury, disease, or illness, that would within reasonable medical judgment cause death within a reasonable period of time in accordance with accepted medical standards, and where the application of life-sustaining treatment would serve only to prolong the process of dying. I further understand in using this form that a permanent unconscious condition means an incurable and irreversible condition in which I am medically assessed within reasonable medical judgment as having no reasonable probability of recovery from an irreversible coma or a persistent vegetative state.”
For many patients this is reasonable, but not for all. No one lives forever, but even a generally healthy 98-year-old does not have a terminal condition. Many of my older patients tell me they are DNR, but most are surprised when I tell them their health care directive says they would want to have CPR and get shocked with a defibrillator if their heart stopped, as they do not have a terminal condition.
I think this is probably a failure of lawyers drawing up the health care directive to modify the language to what makes sense for their clients. I’m not a lawyer, but they might add something like:
(b) If I attain the age of 80-years-old, then I do not want to have my life artificially prolonged, other than using medications, including intravenous medications, and oxygen. An exception is that if I’m undergoing a procedure and develop a cardiac rhythm not compatible with life, then I would approve of an immediate attempt at shocking my heart back into rhythm if the physician deems there is a reasonable chance of success.
Just because a lawyer inserts boilerplate language, does not mean it cannot be changed.
The FDA is proposing a new rule in regards to tobacco regulation. As detailed recently in the New York Times, the benefits of stopping smoking, such as less heart and lung disease, would need to be discounted 70%, making it that much harder to justify spending money on smoking cessation. It sounds like something inserted at the bequest of tobacco lobbyists. Tomorrow is the deadline to make a public comment. Here is what I submitted:
I think it’s a dire mistake to discount the economic and health benefits of stopping smoking because of the loss of enjoyment. Although smokers may get temporary enjoyment from smoking, they also get enjoyment from being healthy. Surely one gets more pleasure taking a walk in a park and living at home, than pushing an oxygen tank down a hall in a nursing home because of severe emphysema. Smokers die at a younger age than they otherwise would. What about the enjoyment their partners, children, and grandchildren lose when the smoker dies prematurely? Loss of enjoyment should not be part of the equation, unless it’s a negative number which would serve to magnify the cost smoking places on individuals and society.
If you apply for health insurance, you may find you have to pay higher rates if you’re a smoker. Now federal regulators are trying to decide if insurers who participate in the Affordable Care Act (aka ObamaCare) exchanges can add a surcharge for those using e-cigarettes or vaporizers. They already can for cigarettes in most states.
Some argue against this, in the name of harm reduction, the idea that if people are going to smoke, it’s better to smoke something safer. For example, Reynolds American Inc spokesman David Howard, said, “We don’t believe policies should be implemented that might deter current smokers from considering switching to smoke-free alternative products like e-cigarettes.”
Numerous studies have, shown, however,that the best way to get people to cut back on smoking, is to make it more expensive. E-cigarettes and vaporizers are cheaper than cigarettes, so paying more for insurance for all forms will encourage more people to stop smoking. No one is suggesting that those smoking alternative forms of tobacco be charged more than those who smoke cigarettes, so even if insurers charge extra for those who use e-cigarettes or vaporizers, they will not pay more than if they stuck with cigarettes, so really it won’t deter smokers from switching. People switch because it costs less, it’s more socially acceptable, or they perceive it to be safer.
In that last regard, vapor may be safer than cigarettes, but we really don’t know. Recent studies show they can definitely have known carcinogens, such as formaldehyde. Would you really want to inhale a chemical used to embalm corpses? I tell my patients that if they use e-cigarettes to help them quit smoking, which may or may not help, then I’m alright with that, but the goal should be to stop using tobacco products, and not just switch from one habit to another.
In 2011 the North Carolina legislature made major changes to the law governing medical malpractice claims. This tort reform, among other things, capped non-economic damages at $500,000.
Such caps on damages do not restrict payments for financial losses, such as future income not earned due to no longer being able to work as a result of injury or death because of something a doctor did, or neglected to do. Rather it limits awards to compensate for such things as pain and suffering.
Physicians in Washington State, and elsewhere, have lobbied for tort reform. Although some physicians have been guilty of gross negligence, in many cases doctors are sued, and juries award large amounts of money, because a patient has suffered, but not necessarily because of something the physician did wrong. Because physicians worry about getting sued, they tend to practice defensive medicine, and order more tests and procedures than necessary as a result. Besides wasting money, it can cause harm. I’ve had patients who have had dozen of CT scans, because every time they go to the emergency room for abdominal pain, they get one to make sure they don’t have such things as appendicitis. The radiation from the CT scan increases the risk of developing cancer in the future. Although such scans are certainly warranted at times, I believe they are excessively ordered because of fear of getting sued.
Between 1929 and 1974, North Carolina forcibly sterilized 7600 people it deemed socially or mentally unfit. Recently the state agreed to set up a $10 million dollar fund to compensate living victims. So far they’ve identified 177, though as of 2010 the State Center for Health Statistics estimated that 2,944 victims may have still been alive. If they end up with 200 such people filing claims, they would each get $50,000. That’s only one tenth of the amount allowed in that state for non-economic damages, and one hundredth if 2000 filed claims, and infinitesimally less in a state that has no such cap. Physicians may be well off, but their pockets are not nearly as deep as a state.
If a physician inadvertently sterilized a patient while treating them for something else, they could be sued for large sums of money for depriving them the chance of procreating. If states can cap non-economic damages for doing the same, isn’t it only fair that limits be placed on non-economic damage for malpractice for physicians who were trying to do the right thing? Although that’s true in about 30 states, the Washington State Supreme Court ruled such caps unconstitutional in Sofie v. Fiberboard Corp., 112 Wn.2d 636 (1989). Although that was not a medical malpractice case, the reasoning goes against the decisions made by a majority of other states, and ignores the fact that resources are limited. No caps in theory means a jury could bankrupt an individual or company, no matter how large, and no matter how many hurt if that happened, all in the name of “justice” to benefit one person, and their legal team of course.
Last week I wrote about the 1st Amendment. This week I’m going to talk about the 2nd. There is an epidemic of gun violence. This is a serious health problem. Watching your diet, exercising, and taking pills is all for naught if a bullet kills you.
In Newtown, Connecticut, one of the worst mass shooting occurred last week when a gunman shot his mother at home, apparently with her own gun, then walked into an elementary school and shot 6 other adults and 20 children, before shooting himself. Gun rights are hotly debated and highly politicized, but gun violence is a serious health issue. The National Rifle Association (NRA) and others have been strong proponents of gun rights, and have fought hard to fight off attempts for even the slightest form of control, including restrictions on semi-automatic and assault weapons.
One of their arguments is that citizens can protect themselves with guns, and that concealed guns are a particularly effective deterrent because potential assailants won’t know who may be armed. But in 61 cased in the US in the past 30 years, maybe only one was stopped by a gun other than their own, or by the police. Even if people want guns to protect themselves, they shouldn’t need to cover the contingency of an invading army, so I see no need for high capacity bullet magazines.
Many mass shooters have mental illness and we need to do a better job providing access to mental health treatments. Some illnesses, such as schizophrenia, often don’t really manifest until people are in their teens or early 20’s, allowing them to purchase guns when their sick enough to do real damage, but not so severe that they would have more trouble planning an attack or convincing someone to sell them a gun. Even if not mentally ill, young men tend to act less rashly as they get older, and are more likely to consider the consequences of their actions. From a list of 22 of the deadliest mass shootings around the world, 65% of them were under 30. We already have a law that says that people can’t buy alcohol until they are 21-years-old, even though they can vote and serve in the military at 18-years-old. Perhaps the right to own a gun should only be allowed for those who are at least 30-years-old.
We need to close legal loopholes, such as sales between private buyers, that allow people to avoid background checks before purchasing guns. I need to fill out more paperwork to prescribe shoes for a diabetic than to buy an assault weapon. We need people to speak up and let our politicians know that gun violence caused by guns is not acceptable. We’ll never prevent all such tragedies, but we should try to minimize the possibility as best we can.
Though implementation has been delayed until 2013, per the Sunshine Law, pharmaceutical companies are now collecting information to report to a public website the value of things they give to physicians, including such things as dinner meetings. It may sound like doctors are just being wined and dined to get them to prescribe their medications, but as I’ve said before, there is value in such dinners.
For example, I went to a local dinner meeting early this year, featuring a speaker who was an expert on hypertension. Sure the meal was free, but not such a bargain when you considered that my wife could not attend, it was with people I might not necessarily have chosen to dine with, and despite a long day at the office, this expert was talking about medicine before I could even look at the menu.
But it was worth it because I learned some valuable information. As a result of hearing him talk, one change I made was to more often start giving at least one blood pressure medication at night because he said it would help prevent early morning strokes and heart attacks. After that meeting I later saw an article confirming the value. Had I not attended the talk I might have eventually changed my prescribing habits, but I changed it sooner as a result. In fact studies have shown it usually takes ten years for doctors to incorporate new medical information into their practice.
The pharmaceutical company that sponsored that dinner has a blood pressure medicine that I use some, but frankly not that much, and it has not increased since that dinner meeting. But perhaps I saved a life as a result of knowledge gained from that meeting.
I serve on WAMPAC, a political action committee for the Washington State Medical Association (WSMA). To help guide our members, last month we met with candidates for Washington State governor Rob McKenna and Jay Inslee. They were both generous with their time and answered our questions.
As physicians, one of our issues is tort reform. We are concerned that large and unreasonable malpractice awards increase the cost of medical care and cause physicians to order unnecessary tests as ‘defensive medicine’. Attorney General Rob McKenna said he was supportive of tort reform, though didn’t give much specifics. Congressman Jay Inslee said he did not believe in malpractice caps because, he said, unlike others, juries are untainted and therefore we need to respect their decisions. That prompted me to send him the following letter. One month later, he has yet to respond. I wonder how I’ll vote in the primary?
Dear Mr. Inslee,
I enjoyed meeting you, and appreciate your spending time to talk with the Washington State Medical Association WAMPAC Committee 7/3/12 regarding your candidacy for governor.
On the issue of tort reform, you mentioned that you didn’t support malpractice caps because you believed in juries making the decision, as they are untainted by lobbyists or others.
Speaking for myself, I have some concerns about this. Short of Plato’s philosopher kings, juries may be the best choice to decide cases, but they are hardly perfect. There are numerous well documented cases of people sentenced to death, yet later found innocent by DNA evidence. In malpractice cases, I would argue that juries are far from perfect. How else could you explain the differences in the chances of being sued and the size of the award based on specialty (http://www.nejm.org/doi/full/10.1056/NEJMsa1012370)? The average neurosurgeon is sued once every 5 ½ years. You would be hard pressed to find a retired neurosurgeon who has never been sued.
Even if juries make perfectly logical decisions, it’s only as good as the cases presented to them, which may be flawed.
In cases where juries decide the outcome, there are restraints. There are judicial guidelines, and juries cannot impose the death penalty for shoplifting, for example, even if they wanted to. Putting financial caps on malpractice cases would be no different. The jury could still decide if the defendant is guilty, but guidelines would cap the size of the reward.
I hope you will reconsider your view on tort reform.