Aaron E. Carroll's Blog, page 138

Readers ask: Is there brain training for hearing loss?

Since publication of my Upshot post about training your brain to improve eyesight for reading, several readers have asked if there are similar approaches to brain training to improve hearing.

I put that question to some experts, but have not received any responses that suggest there is such a thing. In some cases, experts simply did not respond to my email, so maybe those experts know something but aren’t saying!

Point being, right now I’m not aware of how to improve your hearing through brain training. If someone knows otherwise, I’m all ears.

@afrakt

Healthcare Triage: Orphan Drug Costs

Last week, we argued that the benefits of the Orphan Drug Act are more elusive than commonly assumed. But what are its costs? That’s the topic of this week’s Healthcare Triage.

Sources can be found in the posts Nick has written on the subject! Special thanks to him!

@aaronecarroll

Healthcare Triage News: Measuring Safety Might Actually Improve It…At Least Temporarily

Measuring safety might actually improve it. Unfortunately, those improvements fade away when the measurement is over. This is Healthcare Triage News.

This episode was adapted from a post I wrote for the AcademyHealth blog. Links to further reading and sources can be found there.

@aaronecarroll

Uncertainty (Still) Has Consequences – and Trump Knows It

This post was co-authored with Rachel Sachs, a law professor at Washington University School of Law. It has been cross-posted at Take Care, a blog concerned with President Trump’s constitutional duty to take care to faithfully execute the law.

Yesterday, in an interview with the Wall Street Journal, President Trump admitted that he’s toying with the idea of blowing up the ACA in order to extract concessions from Democrats. He’s now threatening to withhold payments to health insurers on the exchanges – crashing the Affordable Care Act’s individual markets and potentially kicking almost 10 million people off of their insurance, overnight.

Let’s take a step back for a moment. As we explained two weeks ago, the single most destructive thing the administration could do would be to end cost-sharing payments to insurers. The relevant question is the fate of House v. Price, a lawsuit brought by the House of Representatives against President Obama’s HHS Secretary (Sylvia Burwell) in 2014:

The House argued that the administration was acting illegally in making cost-sharing payments to insurers because Congress had not specifically appropriated those funds.  A judge on the District Court for the District of Columbia ruled both that the House had standing to sue (wrong) and that the administration’s spending violated the Appropriations Clause (right).

The Obama administration appealed the case to the DC Circuit, but, of course, on November 7, 2016, there was an intervening event: the election of President Trump.  The GOP-led House then asked the court to stay the litigation to see what the future might hold for health reform. The case is being held in abeyance, with the next status report due at the end of May, just days before insurers must file their insurance plans for 2018.

Here’s why the case is such a big deal for the individual markets:  The ACA instructs insurers to limit the out-of-pocket expenses for enrollees who make less than 250% of the federal poverty level.  This cost-sharing cap thus plays a key role in keeping insurance affordable for the low-income population.  The federal government is then supposed to reimburse insurers for cutting those low-income customers a break.

Without an appropriation, however, the federal government can’t keep making those payments. Insurers would remain bound by the statutory requirement that they reduce cost-sharing for their customers, but they wouldn’t get reimbursed.  Without those funds, most insurers will not only refuse to enter the market next year, but may exit the market immediately—cancelling plans and leaving patients uncovered.

(For more on the case, read Nick’s Vox explainer here.)

Don’t just take our word for it. Yesterday, eight large trade organizations representing physicians, hospital systems, insurers, and businesses wrote to the President to emphasize that “[t]he most critical action to help stabilize the individual market for 2017 and 2018 is to remove uncertainty about continued funding for cost sharing reductions (CSRs).” It’s a big deal to send this letter so publicly—especially when some of its signatories are organizations that have staunchly resisted the ACA (including the Chamber of Commerce).

In his interview with the Wall Street Journal, President Trump acknowledged that this arcane appropriations dispute represents an existential threat to the viability of the individual markets: “Obamacare is dead next month if it doesn’t get that money.” But instead of saying whether he would continue making the payments, he’s deliberately perpetuating uncertainty in order to force Democrats to play ball. For Trump, uncertainty is leverage—why would you surrender a negotiating advantage?

But he’s overplaying his hand. Democrats aren’t about to walk away from their most significant legislative achievement of the past fifty years just because of a fight over cost-sharing reductions. They know that Trump will be blamed if the insurance markets burn—we’ve even got polling data on that. Congressional Republicans are likely to be scrambling for a solution, not the other way around. It’s as if Trump is holding a gun to his own head and threatening to fire: maybe he’s crazy enough to do it, but Democrats won’t save him from himself.

Until yesterday, it was possible to believe that the administration’s waffling on cost-sharing reductions was the product of disorganization and Trump’s own weak grasp of policy. But now we know: it’s a deliberate tactic. Trump is holding the coverage of millions of people hostage in a Hail Mary attempt to force some yet-to-be-specified legislative compromise. Worse still, his comments will complicate congressional efforts over the coming weeks to appropriate the money for the cost-sharing reductions.

President Trump may not like the ACA, but he’ll be held responsible if it falls apart. Even before this interview, lingering uncertainty about health reform was undermining the viability of the 2018 insurance markets. Trump’s latest comments will only deepen that uncertainty.

@RESachs and @nicholas_bagley

Making Sense of Invisible Risk Sharing

Mark Hall and I have a piece at Brookings and the Health Affairs Blog that takes a hard look at the “invisible risk sharing program,” the newest Republican amendment to the American Health Care Act. Here’s a taste:

Despite its novel title, the program embodies an idea that has circulated in obscure health policy circles for a quarter century: a behind-the-scenes reinsurance program for higher-risk subscribers whom insurers identify at the point of enrollment. This new (old) approach works differently from the “retrospective” reinsurance that the Affordable Care Act (ACA) used for its first three years. Under the ACA, insurers were reimbursed for enrollees who turned out to be especially expensive (initially, more than $45,000 in a year). Invisible risk sharing, in contrast, requires insurers to identify in advance which people they believe will incur large claims, and “cede” them (and their premiums) to a high risk pool, funded by both insurers and the government. The pool then pays all the medical costs for these ceded “lives” (people) beyond a somewhat lower threshold (e.g., $10,000).

Either form of reinsurance—AHCA’s prospective or the ACA’s retrospective—is “invisible” in the sense that high-cost subscribers are unaware of its existence. And both types of reinsurance use public funds to lower insurers’ costs and thus reduce premiums. Where the two programs differ is that AHCA’s invisible risk sharing pays nothing for people who unpredictably incur large claims.

Neither approach is inherently superior at reducing premiums. Premium reduction depends entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of the new, invisible program unspecified, making it hard to generate precise estimates. But, its $1.7 billion per year funding is no more than 2 percent of total premiums in the market. Whether these funds are injected at the front end, the back end, or in the middle, there is no alchemistic wizardry that can magically make more risk than this simply melt away.

Do read the whole thing!

@nicholas_bagley

AcademyHealth: Checking up on hospitals makes them perform better

The Joint Commission conducts unannounced on-site inspections through surveys at hospitals every 18 to 36 months. The inspections take a week, and the surveyors collect data on patient safety, infection control, medication management, or more. These surveys are a big deal, because they are how the Joint Commission makes decisions on accreditation. Should a hospital lose accreditation, it can affect its reputation, or even result in censure or closure. When a hospital is being surveyed, its employees know, and hospitals now often make it a point to train staff in “survey readiness”.

A new paper in JAMA Internal Medicine looked at how hospital behavior changes when these surveys are being conducted. They didn’t just look at process measures, though; they looked at how patient outcomes changed. Specifically, they looked at how outcomes differed on survey weeks versus non-survey weeks.

Go read more about it in my latest post over at the AcademyHealth blog.

@aaronecarroll

Prescription drugs can be effective. Taking too many can be a problem.

The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

The point of prescription drugs is to help us get or feel well. Yet so many Americans take multiple medications that doctors are being encouraged to pause before prescribing and think about “deprescribing” as well.

The idea of dropping unnecessary medications started cropping up in the medical literature a decade ago. In recent years, evidence has mounted about the dangers of taking multiple, perhaps unnecessary, medications.

Deprescribing will work only if patients also get involved in the process. Only they can report adverse effects that they sense but that are not apparent to clinicians. And they need to be comfortable weaning from or dropping drugs that they are accustomed to and believe to be helpful.

Yet an increasing number of Americans — typically older ones with multiple chronic conditions — are taking drugs and supplements they don’t need, or so many of them that those substances are interacting with one another in harmful ways. Studies show that some patients can improve their health with fewer drugs.

Though many prescription drugs are highly valuable, taking them can also be dangerous, particularly taking a lot of them at once. The vast majority of higher-quality studies summarized in a systematic review on polypharmacy — the taking of multiple medications — found an association with a bad health event, like a fall, hospitalization or death.

About one-third of adverse events in hospitalizations include a drug-related harm, leading to longer hospital stays and greater expense. The Institute of Medicine estimated that there are 400,000 preventable adverse drug events in hospitals each year, costing $3.5 billion. One-fifth of patients discharged from the hospital have a drug-related complication after returning home, many of which are preventable.

Not every adverse drug event means a patient has been prescribed an unnecessary and harmful drug. But older patients are at greater risk because they tend to have more chronic conditions and take a multiplicity of medications for them. Two-thirds of Medicare beneficiaries have two or more chronic conditions, and almost half take five or more medications. Over a year, almost 20 percent take 10 or more drugs or supplements.

Some are unnecessary. At least one in five older patients are on an inappropriate medication — one that they can do without or that can be switched to a different, safer drug. One study found that 44 percent of frail, older patients were prescribed at least one drug unnecessarily. A study of over 200,000 older veterans with diabetes found that over half were candidates for dropping a blood pressure or blood sugar control medication. Some studies cite even higher numbers — 60 percent of older Americans may be on a drug they don’t need.

Though studies have found a correlation between the number of drugs a patient takes and the risk of an adverse event, the problem may not be the number of drugs, but the wrong ones. Some medications have been identified as more likely to contribute to adverse events, particularly for older patients.

For example, if you’re taking psychotropic agents, such as benzodiazepines or sleep-aid drugs, you may be at increased risk of falling and cognitive impairment. Diuretics and antihypertensives have also been identified as potentially problematic. (The Agency for Healthcare Research and Quality has published a longer list of drugs that are potentially inappropriate for older patients. Note that, even if they are problematic for some patients, they are appropriate for many.)

Relative to the mountain of evidence on the effects of taking prescription drugs, there are very few clinical trials on the effects of not taking them.

Among them is one randomized trial that found that careful evaluation and weekly management of medications taken by older patients reduced unnecessary or inappropriate drug use. Adverse drug reactions fell by 35 percent. Medication use was reduced, along with the risk of falls among a group of older, community-dwelling patients through a program that included a review of medications.

Several other studies also found that withdrawal of psychotropic medications reduced falls. A comprehensive review of deprescribing studies found that some approaches to it can reduce the risk of death. Another recent randomized trial found that frail and older people could drop an average of two drugs from a 10-drug regimen with no adverse effects.

So why isn’t deprescribing more widely considered? According to a systematic review of research on the question, some physicians are not aware that they’re prescribing inappropriately. Other doctors may have difficulty identifying which drugs are inappropriate, in part because of lack of evidence. In other cases, doctors believe that adverse effects of drug interactions are outweighed by benefits.

Physicians also report that some patients resist changing medications, fearing that alternatives — including lifestyle changes — will not be as effective. Other studies found that many doctors are concerned about liability if something should go wrong or worry they’ll fail to meet performance benchmarks — like the proportion of diabetic patients with adequate blood sugar control.

To reduce the chances of problems with medications, experts advocate that physicians more routinely review the medication regimens of their patients, particularly those with many prescriptions. At hospital discharge — when patients leave the hospital, often on more medications than when they entered it — is a particularly important time for such a review. Including nurses and pharmacists in the process can reduce the burden on physicians and the risks to patients.

Patients can play an important role as well. Walid Gellad, a physician in the Veterans Health Administration and at the University of Pittsburgh School of Medicine, advises that at every visit with a doctor, “patients should ask, ‘Are there any medications that I am on that I don’t need anymore, or that I could try going without?’ ”

Patients, of course, should not try weaning themselves off medication without consulting their doctors — but deprescribing is an idea for all parties to keep in mind.

@afrakt

Healthcare Triage: Orphan Drugs: An Introduction

We at Healthcare Triage couldn’t be more excited about this month. We’re doing a whole month on orphan drugs, with the help of Nick Bagley. He wrote a lot about them, and we begged him to let us adapt his work into a series. This is the Introduction. Over the next few weeks, there will be three more. Enjoy!

Sources can be found in the posts Nick has written on the subject!

@aaronecarroll

Waivers and the future of repeal and replace

Over at National Review, Yuval Levin argues that a Republican consensus over repeal and replace might slowly be emerging:

It now seems that the familiar debates about tax credits vs. deductions and even about spending levels aren’t exactly where the dividing lines are in the House conference. Rather, … the Freedom Caucus Republicans want to maximize the reversal of Obamacare’s federalization of health insurance regulation to give people more options at lower costs and the Tuesday Group Republicans want to maximize genuine access to coverage and care for everyone in the individual market. Both want a more functional, competitive, consumer-oriented health-care system. And it’s not that either group simply doesn’t care about the other’s primary emphasis, but they do seem to enter the debate with these differences of emphasis and priority. The challenge, therefore, is to maximize both at the same time.

This is good news, because both of those are crucial goals and they can actually reinforce one another. But how do you maximize both … ? I think the waiver idea is an attempt to answer that question. In effect, it says to each state government that, if it can show that Obamacare’s regulations make it too hard for its residents to have a functional individual insurance market and can demonstrate how a different regulatory architecture would better enable it to make use of whatever federal support the legislation would offer and provide more people with access to coverage and care, then it can have that different regulatory architecture. How this might be achievable will vary from state to state, and a waiver approach can make room for such variance. It will also look different to state officials with different assumptions about health economics, which this approach could allow for as well.

It’s a good piece, and I’m sympathetic to Levin’s view that shifting more regulatory authority to the states is a good idea. (Andrew Sprung, who has a detailed and insightful discussion of Oklahoma’s nascent exploration of 1332 waivers, has also explored how decentralization might play into a Republican replacement.)

But I think Levin is wrong about what really divides Republicans. Levin’s mistake—and it’s a common one—is neglecting the role that money plays in federalism. It’s fine to give the states more authority to oversee their insurance markets. But, as I explain here, states don’t have the fiscal capacity to finance massive coverage expansions on their own. They’re required to balance their budgets every year, so any commitment to covering the uninsured will throttle their budgets when the next downturn comes. At the same time, ERISA prevents them from adopting the sort of employer mandates that could improve coverage.

The states thus need federal money; it’s the lifeblood of health reform. And the real cleavage among Republicans is over how much money the federal government is willing to shell out. The Freedom Caucus wants to repeal the ACA’s taxes on industry and the wealthy, financing them with savage cuts to Medicaid and slightly less savage cuts to individual-market subsidies. The Tuesday Group likes the tax relief, but worries about the coverage losses associated with all the cuts.

It’ll take more than waivers to bridge that gap.

It’s telling, for example, that Levin doesn’t mention the Cassidy-Collins bill, which would have granted broad authority to the states to opt out of the ACA’s regulations. Cassidy-Collins was dead on arrival not because it embraced waivers, but because it would have retained the ACA’s taxes and spending. For most Republicans, that’s a deal-breaker.

It’s also telling that Levin doesn’t discuss Medicaid in the piece, even though Republicans remain divided over whether and to what extent to keep the expansion in place. Again, the problem is not opposition to more state control: House Republicans were happy to adopt an amendment allowing states to impose work requirements. The problem, instead, is that Republicans disagree about how to trade off tax relief and Medicaid cuts.

When Levin talks about a federalism-respecting solution, he seems to have in mind something that hews to the anemic spending levels in the American Health Care Act. Even with much less money, he’s optimistic that the states can achieve broad coverage by eliminating ACA regulations. Here, however, he seems to be referring exclusively to the individual market. But if you take the AHCA’s Medicaid cuts as a given, as Levin seems to, a huge increase in the number of the uninsured is inevitable.

Even just focusing on the individual market, Levin understates the effect of the AHCA cuts. Levin opines, for example, that the states might “permit catastrophic coverage plans to be sold and then require every insurer in the individual market to offer at least one ‘default’ catastrophic plan with a premium equal to the federal credit so that everyone can have at least minimal coverage and no one remains uninsured.”

Levin is right: the states could do this. But play it out. In many markets, the credits under discussion in the AHCA are too low to cover the premiums for catastrophic plans. If you’re 35 and live in Nashville, Tennessee, for example, catastrophic coverage will run you about $287 per month, or $3,450 per year. But the AHCA’s credit for someone in that age bracket is just $2,500.

Selling a catastrophic plan at the size of the tax credit will therefore require insurers to increase their deductibles. But catastrophic plans already impose deductibles of $7,150 for an individual—that’s as much as the ACA permits. With that cap on out-of-pocket spending waived, we’d likely see the proliferation of catastrophic plans with deductibles in the five digits.

That’s still “minimal coverage” in some sense. But it’s also less coverage than the ACA guarantees—and five-digit deductibles make the Tuesday Group nervous. The same goes for other regulatory changes, like paring back the essential health benefits. Fewer regulations might yield a reduction in premiums, but people’s insurance would be crappier and less comprehensive. Voters tend to get mad when you make their coverage crappier and less comprehensive.

Contra Levin, then, I don’t think the logjam among Republicans is conceptual. It’s financial. Some Republicans want to stop paying as much for health care for the poor and near-poor. Others think that’d be political suicide. No amount of waivers will get them to agree.

@nicholas_bagley

Birth Control Causes Depression? Not So Fast

I was on vacation and off the grid last week. So I missed posting on some stuff. Like this, which originally appeared on The Upshot (copyright 2017, The New York Times Company).

One of the biggest American public health victories of the last decade has been the record low reached in the teenage birthrate. Along with that have been lows in rates for teenage pregnancy and abortion. Most researchers believe that improved access to contraception is a large part of this success.

But news continues to focus on the concern that hormone-based contraception — like the pill or the patch — causes depression, and that this should lead us to question its wider use. A more nuanced discussion would consider both the benefits and the harms.

This issue drew widespread coverage at the end of last year with a large study published in JAMA Psychiatry. Researchers tracked all women and adolescent females (ages 15 to 34) living in Denmark from 2000 through 2014. The study found that those who used hormonal contraception had significantly higher risks of also taking an antidepressant.

The study broke down the increased relative risk for each hormonal method this way: combined oral contraceptives (23 percent), progestogen-only pills (34 percent), the patch (100 percent), vaginal ring (60 percent) and levonorgestrel intrauterine system (40 percent).

The risks were highest in adolescents and decreased as women aged. The risks also peaked six months after the start of contraception.

Needless to say, many news outlets covered this finding widely. Some portrayed it as shocking new information that should change the way we think about hormonal birth control. Others saw it as a vindication of many women who said for years that birth control had triggered their depression while scientists and doctors ignored them.

But we have to acknowledge the limitations of this type of research. It’s not a controlled trial, and it’s impossible to establish causality. Women who choose to have sex could also be more likely to consider antidepressant use. Women who are plugged in enough to the health care system to obtain hormonal contraception could be more likely to have their depression appropriately diagnosed and treated — which is a good thing.

It’s also possible that an antidepressant prescription isn’t the best measure of new-onset depression. That would require an actual diagnosis by a health care professional, and such data were not available in the Danish cohort.

Previous studies that looked at rates of severe depression did not find a correlation with hormonal birth control use. Finally, huge cohort studies using many participants are likely to find a statistically significant result even if that result is not clinically significant. This is especially true if the cohort data come from an administrative database, like the one used in this study, that has been specifically identified as problematic in prior publications.

We also have to place this study in context with others. Months earlier, a systematic review of all studies that looked at the relationship between hormonal contraception and depression was published in The European Journal of Contraception and Reproductive Health Care. The authors first noted that there were too few prospective studies. But the data that do exist show that most women don’t show any effect from hormonal birth control, or actually had their mood improve.

Adverse effects were rare, and even rarer when the contraception contained lower levels of the hormone progestin. Finally, women who have underlying mood disorders were more predisposed to have mood-related side effects, but that could be related to their choosing different types of birth control rather than the birth control itself.

When many studies do not find a connection, and then one does, that latter one does not “replace” all prior research. That study has to be weighed along with the rest. It’s also important to consider publication bias, in which a study is more likely to be published if it’s a “significant” result and if it’s newsy. In this case, the finding that common birth control causes depression is both.

But let us assume, for the sake of argument, that this most recent finding is both real and causal. Even then, we need to rely on absolute risks, not relative risks. In the Denmark study, for every 100 women who didn’t use hormonal birth control, 1.7 were later prescribed an antidepressant. For every 100 who did use hormonal birth control, 2.2 were later prescribed an antidepressant. The overall difference (0.5 percentage points) means that if this were a randomized controlled trial, we would expect that for every 200 women treated, one extra woman might need to be treated with an antidepressant.

We can also assume, though, that pretty much all of them would receive the benefit of birth control in family planning. Moreover, lest anyone forget, depression is also significantly associated with pregnancy, especially when that pregnancy is unintended.

None of this is to say that we should ignore the risk of depression. Depression is a listed side effect of birth control; it’s on the package inserts.

All drugs have side effects. The drug I take for my ulcerative colitis has a real, if small, risk of causing myelosuppression. But the benefits I receive from it simply outweigh the risks.

Women need to discuss with their physicians the potential downsides, as well as the potential upsides, of all forms of contraception. We shouldn’t ignore the potential for hormonal birth control to cause mood changes in women. We also shouldn’t pay attention only to those side effects, forgetting to place them in context with the benefits.

@aaronecarroll