• Deferring to the IRS

    Given the Chief Justice’s near-silence at oral argument in King v. Burwell, much will be made of Justice Kennedy’s sensitivity to the argument that accepting the plaintiffs’ interpretation of the statute would raise serious federalism concerns. That’s completely appropriate.

    But I want to call attention to a different question that Kennedy asked the government’s attorney. In a seminal case, Chevron v. Natural Resources Defense Council, the Supreme Court held that the courts should generally defer to an agency when it resolves an ambiguity in the statute that it administers. Kennedy asked whether Chevron should apply here.

    Well, if [the statute is] ambiguous, then we think about Chevron. But it seems to me a drastic step for us to say that the Department of Internal Revenue and its director can make this call one way or the other when there are, what, billions of dollars of subsidies involved here? … And it—it seems to me our cases say that if the Internal Revenue Service is going to allow deductions using these, that it has to be very, very clear.

    Kennedy is picking up on an argument made in the plaintiffs’ brief that the Court shouldn’t read the ACA to delegate to the Treasury Department (which houses the IRS) the authority to resolve a question this big and important, especially where it involves something akin to an exemption from federal taxation.

    In asking the question, Kennedy could be hinting that he’s reluctant to construe the ACA to contain the sort of ambiguity that would normally trigger Chevron deference. Then again, he might just be putting the government through its paces. It’s tough to say.

    Fortunately, there’s an answer to Kennedy’s question. I drafted an amicus brief explaining why deferring to Treasury here would be entirely appropriate. As the brief explains in part:

    It is true—but irrelevant—that “when an agency claims to discover in a long-extant statute an unheralded power to regulate ‘a significant portion of the American economy, this Court typically greets its announcement with a measure of skepticism.” … [Yet, f]ar from unexpectedly arrogating to itself regulatory powers on the basis of statutes enacted some decades earlier, Treasury has issued a predictable—indeed, indispensable—rule that articulates the basic parameters governing the availability of new tax credits. It is unclear how Treasury could have implemented the tax-credit provision at all without first resolving whether tax credits were available in states that declined to establish their own exchanges.

    Chevron deference is all the more appropriate when agencies confront big, difficult questions that arise in the course of administration. “It is then that the agency’s expertise and political accountability are most essential—and where the structure of the federal government most forcefully counsels judicial restraint.”

    The plaintiffs are also wrong to suggest that Chevron has no application where the statute in question involves tax credits. In a 2011 decision, Mayo Foundation for Medical Education & Research v. United States, the Supreme Court held that Chevron supplied the right framework for measuring the legality of a Treasury Department interpretation of a statutory tax exemption. As the amicus brief explains:

    Although petitioners claim fidelity to Mayo Foundation, their argument, if accepted, would effectively wipe that decision from the U.S. Reports. Tax law is so arcane mainly because of the thousands of exemptions and deductions that stud the Internal Revenue Code. Interpreting those provisions occupies much of Treasury’s administrative time and attention. …

    As this Court reasoned in Mayo Foundation, the complexity of this task—the difficulty of interpreting all those exemptions and deductions—militates in favor of, not against, Chevron deference. [The plaintiffs], by contrast, invite the federal courts, not the experts at Treasury, to take the lead in administering huge swathes of the tax code.

    In other words, the IRS rule is precisely the sort of agency action that is owed deference under Chevron. Here’s hoping that Justice Kennedy sees it the same way.

    @nicholas_bagley

     

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  • ‘Pennhurst:’ Reason for optimism in King, or reason for worry in other areas of the law?

    With oral arguments in King this week—today!—I’ve temporarily reprised my my Vox-writer role. Yesterday, I published a piece on Pennhurst, a legal doctrine that could prove consequential. Like Chevron, it hinges on the justices reading the law as ambiguous, but Pennhurst is a doctrine that demonstrates deference to the states—not to federal agencies—so it might prove more palatable to the conservative justices.

    The government does have one legal doctrine, however, that might be especially persuasive to right-leaning judges. It’s called the Pennhurst doctrine, and its all about ensuring that the federal government doesn’t violate state rights.

    Legal scholars defending Obamacare think this argument may resonate with the court’s conservative wing, but some worry that a ruling on Pennhurst grounds could have implications that stretch far beyond health reform.

    The rest is here.

    For a really interesting, more historical take on the doctrine, you should absolutely read Noam Levey.

    Adrianna (@onceuponA)

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  • In defense of the NNT

    Hilda Bastian pushed back against recent promotion of the concept of the number needed to treat (NNT), including the post authored by me and Aaron at The Upshot. Bastian’s main point is that the NNT is too complex for patients, and therefore not helpful in communicating risk reduction of treatments. In her post, titled “The NNT: An Overhyped and Confusing Statistic,” she wrote,

    [An NNT] takes data about patients, inverts it to a “treater” perspective, and then requires them to go through cognitive gymnastics to get back to their point of view.

    Well before my Upshot post with Aaron published, I was aware that this was a common feeling about the NNT, which is why I dug into the literature on how well the metric is understood. I wrote up my findings last November on the AcademyHealth blog. You can read the details at the link, but here’s my conclusion: As to whether patients have difficulty understanding NNT, relative to other metrics of risk reduction,

    the evidence base is both thin and inconclusive. There are two relevant studies about NNT comprehension included in two systematic reviews. They point in opposite directions.

    My conclusion is that NNTs may, in fact, perform quite well relative to other measures. Or maybe they don’t. We don’t know. They may perform even better for practitioners than for patients, but we don’t know that either. What we can’t say from the evidence, however, is that NNTs are harder for people to understand than other metrics of risk. From two studies with conflicting findings, we just don’t know that.

    Bastian, on the other hand, came to a strong conclusion about the comprehension challenges posed by the NNT. After considering natural frequencies, relative risk reduction, absolute risk reduction, and NNT, she wrote, “Which of these is the hardest for patients and clinicians to understand? The evidence points to the NNT being the hardest.”

    Because our evidence-based conclusions differ, I tweeted at her. You can read her response below:

    I always take charges that I missed some evidence seriously. That’s not only because of a desire to be right, but also because I’m always eager to learn when I might have been wrong. What evidence did I miss? Looking for it, I went through every link of her post. Here’s what I found:

    • As background, she cites a Wired magazine piece on NNT. Aaron and I also cite it, and I did in my AcademyHealth post as well.
    • About NNT’s development, she cites Laupacis et al. (1988). Aaron and I do as well.
    • Her evidence that the NNT is harder to understand than other metrics of risk reduction are the same 2011 Cochrane review and 2014 review by Zipkin et al. that I also examined. In my post, I dug into what they cited as evidence. It’s not very convincing, as I explained.
    • Bastian cited a survey of urologists by Dahm et al. that I “overlooked.” (My focus was on patients, not physicians, but never mind that. I wish I had seen this study because I would have put it to use.) The study found that “[t]he percentage of respondents who indicated that they ‘understand and could explain to others’ the term[] number needed to treat […] was 42%.” That sounds, well, not so good, until you look at the results from that same study for relative/absolute risk (the only other risk reduction metrics considered): about 20% of responding urologists said they could understand and explain those ideas (see Figure 2, which I’ve included at the end of this post). So, this study hardly supports the idea that the NNT is more difficult to understand and explain than other common metrics of risk reduction.
    • She cited qualitative work on how patients engage with evidence-based health information. I confess to not have considered qualitative work because one cannot use it to draw quantitative conclusions. Nevertheless, that work concluded, “Further research is needed to examine strategies to explain the specific character of EBHI [evidence-based health information] so as to minimize unintended or adverse reaction patterns.” More research needed! That’s not the same thing as “NNTs are confusing!”
    • She cited work by Trevena et al. that I had not read. It argues that we need to communicate in a way that does not require people to do mental gymnastics they find challenging. OK, I fully agree with that. The goal is to find that way, which may differ by population and situation. So far, I see no basis for rejecting NNT from consideration.

    Ultimately, I just can’t agree with Bastian—based on the evidence she cited, all of which I have now considered and the most relevant of which I had already—when she says,

    [S]o many supporters of evidence-based medicine [] remain in favor of a form of communication [NNT] that itself is, let’s face it, pretty contrary to the evidence.

    Well, it seems we support NNT as possibly useful because we have not seen a convincing body of evidence to the contrary. And, I should add, Aaron and I have not claimed that the NNT is perfect or superior for all settings. We find it valuable, as do others, but your mileage may vary. That’s fine!

    For all that, I agree where Bastian ends up.

    Statistics aren’t value-free, even though they are more objective than many other ways of distilling information. They’re difficult to translate for people who don’t already “get” them very well in their original form. You need lots of context and several statistics to get a handle on the results of most clinical studies anyway.

    Quite right. But is it clear that the NNT can’t play a role? Dr. David Newman, a champion of the NNT and one of the creators of theNNT.com, put it to me this way:

    The purpose of using the NNT is to refine communication so that the negative space (all those not affected) are never left out of the conversation, as they so commonly are. To talk about relative numbers as if they’re as good as or better is deeply misleading. They are much, much worse, and all studies validate that. They may leave people feeling like they understand, but they misunderstand, and in dangerous ways.

    I would never advocate using the NNT in low literacy populations as a sole method of communication, or in any population where it is not understood and commonly used. But first, this is a tool that takes some getting used to. Once everyone’s on the same page it can be an absolute goldmine to have this device. And second, for those not acclimated, it should be used alongside other devices to ensure that someone understands, in the moment.

    There is no one device that works for that—patient communication is an art (think: painting), and devices are the medium (think: paintbrush). The brush is much less important than the final product, and if a device helps you get there, then we’re all on board.

    Still, maybe I have missed or misunderstood some evidence that strongly points to the NNT being too confusing to consider a worthy arrow in the quiver. If so, what is it? By email, Hilda Bastian generously offered to pull together some that had been left out of her post. I look forward to seeing it.

    ***

    From a Survey of Urologists (Dahm et al.)

    urologists risk reduction metrics

    @afrakt

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  • Patients overestimate benefits, underestimate harms of treatment. What if they knew the truth?

    The following is co-authored by Austin Frakt and Aaron Carroll. It originally appeared on The Upshot (copyright 2015, The New York Times Company). Click over to that version of the post to see the accompanying chart.

    If we knew more, would we opt for different kinds and amounts of health care? Despite the existence of metrics to help patients appreciate benefits and harms, a new systematic review suggests that our expectations are not consistent with the facts. Most patients overestimate the benefits of medical treatments, and underestimate the harms; because of that, they use more care.

    The study, published in JAMA Internal Medicine and written by Tammy Hoffmann and Chris Del Mar, is the first to systematically review the literature on the accuracy of patients’ expectations of benefits and harms of treatment. They examined over 30 studies that assessed whether patients understood the upsides or downsides of certain treatments. To a great extent, patients didn’t.

    In the 34 studies that assessed understanding of benefits, patients overestimated their potential gain in 22 of them, or 65 percent. For instance, a 2002 study published in the Journal of the National Cancer Institute asked women who had undergone prophylactic bilateral (double) mastectomy to estimate how much the procedure reduced their risk of breast cancer. On average, the women thought they had reduced that risk from 76 percent to 11 percent, an absolute risk reduction of 65 percentage points.

    For the more than 80 percent of the women in the study who did not have a BRCA genetic mutation — which drastically increases the risk of breast cancer — the real risk before surgery of developing breast cancer was 17 percent, meaning they greatly overestimated their risk reduction. Even the women with a BRCA mutation overestimated their risk reduction, but to a lesser extent.

    Another 2012 study published in the Annals of Family Medicine asked patients to estimate the benefits of screening for bowel and breast cancer, and the use of medications to prevent hip fracture and cardiovascular disease. More than two-thirds of patients overestimated the benefits of medications to prevent cardiovascular disease, and more than 80 percent overestimated the benefits of medications to prevent hip fractures.

    Further, 90 percent of patients overestimated the benefits of breast cancer screening, and 94 percent overestimated the benefits of bowel cancer screening. The researchers also asked the patients to estimate the minimum reduction in bad outcomes (like fractures or deaths) they would need to achieve to find the treatment worthwhile. For three of the four studied interventions, the minimum benefit patients would accept was higher than the actual benefit.

    In the 15 studies examined in the systematic review for which harms were a focus, patients underestimated potential downsides in 10 of them (67 percent). For example, a study published in 2012 in the Journal of Medical Imaging and Radiation Oncology asked patients to estimate the risks associated with a CT scan. A single CT scan exposes a patient to the same amount of radiation as 300 chest X-rays, and carries with it a 1-in-2,000 chance of inducing a fatal cancer. More than 40 percent of patients underestimated a CT’s radiation dose, and more than 60 percent of patients underestimated the risk of cancer from a CT scan.

    Why do patients err in assessments of risks and benefits? One reason could be that what they know is driven by the messages they hear. Doctors, direct-to-consumer ads and the media can skew our perceptions. They tend to focus on the benefits, but rarely quantify them. Health care centers, screening advocacy programs and pharmaceutical ads all push us to talk to our doctors about getting treatment without talking about actual gains.

    Doctors also aren’t always good at communicating risks. A 2013 study published in JAMA Internal Medicine found that fewer than 10 percent of patients were told about overdiagnosis and overtreatment associated with cancer screening, even though 80 percent of patients wanted to know about harms.

    This study, and others, indicate that patients would opt for less care if they had more information about what they may gain or risk with treatment. Shared decision-making in which there is an open patient-physician dialogue about benefits and harms, often augmented with use of treatment decision aids, like videos, would help patients get that information. However, a majority of patients still report that they prefer to leave medical decision-making to their doctors.

    It might also be the case that some patients would use more of certain types of care if they had more information. Many chronic conditions remain undermanaged and undertreated in the United States. It’s possible that people with these conditions who had more information would use more care, which could raise spending for these patients but make them better off.

    There’s also an argument to be made that people who overestimate the benefits of medicine to treat some conditions are more likely to take it regularly, which might lead to better outcomes, in some cases, than would occur if these patients were better informed.

    Regardless, even though some patients may benefit somewhat from being ill informed, it seems wrong to argue that we should keep them in the dark. Many of the studies in the systematic review show that people report that they would opt for less care if they better understood benefits and harms. Improved communication could better serve patients and might improve the efficiency of our health system if patients focus on getting the types of care for which the benefit outweighs risk of harm.

    It’s also possible that unrealistic expectations of care help patients cope with disease or provide them with some sense of control. Feeling hopeful about one’s future is not to be dismissed. But those unrealistic expectations don’t come cheap. We should at least consider the price that we pay for being uninformed.

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  • Our little blog has come a long way

    This is a screenshot I took of yesterday’s New York Times home page (annotated by me, of course):

    TIE NYT

    There are times it’s nice to pause and reflect on how far this little blog has come. We’re grateful to all of you for your support! In case you missed the individual pieces, here is Nick’s op-ed and here is Austin and my Upshot piece.

    @aaronecarroll

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  • Subjective vs. objective value in health care

    In assessing “value” in health care, there’s a bit of tension among the experts. Some emphasize satisfaction, others quality metrics. It’s subjective vs. objective. Which way is best?

    I’ve been mulling this over for some time, and will begin to write about it—not in a fully formed way, but by conveying a few responses to articles as I read them. This post is about the excellent 2013 NEJM piece by Lisa Rosenbaum.

    Using the famous “illusion of attention” gorilla study by Daniel Simons and Christopher Chabris as an analogy, Rosenbaum says what I noted above, “[v]alue in health care [] depends on who is looking, where they look, and what they expect to see.”

    When I consider which is best, subjective vs. objective notions of value, I am reminded of optical illusions in which one can see different images depending on how one looks. One can flip between them, but it’s hard to see both images in the mind’s eye at once.

    old_woman_or_young

    Do you see a young or old woman?

    Like seeing either the young or old woman (or flipping between them), both aspects of value seem to have merit. Your subjective experience matters and is valid, not least of which to you. It’s your body on the line! But your care is also financed with my dollars (through taxation or collective premium funds, or both). I don’t want you to spend it on objectively “bad” or “lower value” care. It’s my money on the line!

    The wedge between these two views is similar to Rosenbaum’s observation that “[t]he value narrative effectively splits patients and physicians into separate teams.” Focusing on physicians invites objective measures. They’re the product, in a way. Like the specs of a car or phone, it’s natural to want to know what we’re getting for the price.

    Focusing on patients invites subjective considerations. They’re the customer, in a way. (Ignoring third-party payment that complicates that notion.) And we all know it’s darn near impossible to make a fully objective decision about almost any product. Often it comes down to, “How does it make me feel?” (This is the basis of most marketing, whether it works or not.)

    Rosenbaum tells the story of Mr. W who is “crippled by worry” over the possibility he has heart disease. He won’t be satisfied until he receives the test that rules it out. There is no such test and cardiac imaging, among other types of imaging, is among the services that are overused. Objective metrics suggest that more testing might do more harm than good. Subjectively, will this satisfy the patient? When considering tests and procedures for which there is no clear evidence of benefit or harm, the answer is harder still. When things are vague, do we bias toward or away from treatment? How much weight do we give satisfaction?

    One recent study showed that patients who present to the emergency department with abdominal pain are more confident that they have received good care if they undergo an abdominal CT scan than if a physician simply examines and reassures them. In the case of back pain, for which imaging is frequently used and we have outcomes data and guidelines to inform decisions, two studies have shown that patients who undergo magnetic resonance imaging, even when it is not medically necessary, are far more satisfied with their care than those who do not. [Links added.]

    On the other hand, there is also evidence that what patients really want is to be listened to, for their concerns to be understood and taken seriously. That suggests the route to patient satisfaction might not be an imaging study, a procedure, or a pill. Perhaps a thorough conversation is what the patient really seeks. When it was explained to Mr. W why additional testing wouldn’t be helpful (but some other things might), he replied with relief, “No one has ever explained any of this to me before.”

    To the extent that (subjective) satisfaction and (objective) evidence-based care align, the apparent conflict between the two evaporates. It’s not likely this will always occur or that getting it to do so where possible is easy. There’s likely room for both notions of value. Getting them to work in concert may require clinicians and patients to communicate differently, which takes time and effort. It sounds simple, but it’s a big challenge.

    @afrakt

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  • My obligatory post on penis size

    When we wrote our first book on medical myths, our agent told us we had to “sex it up”. That’s how the first chapter of my first book came to be “Men with big feet have bigger penises”. This made for a problem when my then-five-year-old son opened his copy and nearly had his eyes bug out of his head.

    This is also how a chapter in our second book on medical myths was entitled “You can make your penis bigger without surgery”. It’s how the first chapter in our third book on medical myths came to be “Penis size matters”. In fact, the first three chapters of the last book were about penises.

    People are obsesses with penises, especially their size. Penises sell books. They evidently also get manuscripts published. “Am I normal? A systematic review and construction of nomograms for flaccid and erect penis length and circumference in up to 15 521 men“:

    Objective: To systematically review and create nomograms of flaccid and erect penile size measurements.

    Methods: Study key eligibility criteria: measurement of penis size by a health professional using a standard procedure; a minimum of 50 participants per sample. Exclusion criteria: samples with a congenital or acquired penile abnormality, previous surgery, complaint of small penis size or erectile dysfunction. Synthesis methods: calculation of a weighted mean and pooled standard deviation (sd) and simulation of 20 000 observations from the normal distribution to generate nomograms of penis size.

    I imagine this is the definitive systematic review. Here’s the nomogram:

    Penises

    It’s small unfortunately, so let me break it down for you. If your erect penis is 4.7 inches, you’re at the 25th percentile. If your erect penis is 5.1 inches, you’re at the median. Half of men have bigger penises, and half have smaller. If your penis is 5.6 inches, then congratulations – you’re in the 75th percentile. If you have a six inch erect penis (which is what many people “think” is average, then you’re in the 90th percentile.

    What’s striking here, though, is that most men are pretty much the same. The idea that seven inch penises are common appears to be – wait for it – a myth. Ninety-five percent of men have penises smaller than 6.3 inches. More than half of men have a penis that’s between 4.5 and 5.5 inches, and only 15% are smaller than 4.5 inches.

    Everyone should stop worrying about this. I’d love to stop writing about it.

    @aaronecarroll

    (h/t CommonHealth)

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  • Healthcare Triage: Cost Effectiveness in Medicine is not a Dirty Word

    Last week, we discussed how to measure the utility value of different health states. These can be used as a proxy for quality in measuring how effective therapies are. How? That’s the topic of this week’s Healthcare Triage.

    For those of you who want to read more, this was adapted from a piece I wrote for the Upshot in the NYT. Links are there if you want to read more.

    @aaronecarroll

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  • AcademyHealth: How do changes in Medicaid affect access for kids?

    A lot of time, and a lot of ink, has been spent talking about access and Medicaid. Many who oppose the expansion of the program will point to the fact that sometimes evidence shows that fewer doctors accept Medicaid insurance than other types of coverage. There’s some truth there. Medicaid does often reimburse at a lower rate than other insurance coverage, and sometimes doctors don’t want to accept those lower rates. But there’s more to the story.

    That’s me in my latest post over at the AcademyHealth blog. Go read the rest!

    @aaronecarroll

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  • Healthcare reform is a marathon, not a sprint

    King v. Burwell will be argued before the Supreme Court this week. It won’t be decided, just argued. Then, we’ll parse how well the arguments went, and whether we can predict what will happen from that show. Last time, by the way, we couldn’t. Then, in June, we’ll get a decision.

    I know lots of people (including possibly everyone else at this blog) think the plaintiffs will win. Putting my cards on the table – I’m not one of them. I think the Justices will rule for the government, but I admit that’s a gut feeling. I may be wrong.

    But the world won’t end overnight, and neither will the ACA. It will still function in a subset of states. I think even more will take quick action to fix their exchanges. I have a hard time believing that any state that accepted the Medicaid expansion won’t find a way to accept subsidies for their citizens who are working. So we’ll be left with a minority of states that don’t have subsidies and have a broken individual insurance market.

    That’s where history comes in. I’ve said it before, but it bears repeating: All of this has happened before and will happen again. Medicare was, at one time, the death of freedom. Go read this piece on what people thought when “traditional” Medicaid was first passed in 1965. Then remember that Arizona, the last state to accept Medicaid, finally did so in 1982.

    Between 1965 and 1982, we had a country where a program existed to cover all poor children, all poor pregnant women, the poor elderly, and many poor parents – but only in some states and not in others. The Earth continued to spin on its axis. The country survived. It was ridiculously unfair for some people who lived in states that refused to accept Medicaid, but eventually, all the states did.

    The same can be said of the US if the Supreme Court finds for the plaintiffs. But, as with Medicaid, I think it’s likely the ACA will survive. I also believe, someday, that someday the Supreme Court will view the removal of the ACA as “coercive” as it viewed the removal of traditional Medicaid just a few years ago.

    @aaronecarroll

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