Aaron E. Carroll's Blog, page 126

Healthcare Triage: Homicide and Firearms – Guns and Public Health Part 2

Let’s be clear. The biggest thing people worry about with guns in the US is homicide. There are lots of ways to look at the data, and most don’t make the US look very good. Prepare for a deep dive.

This series was produced with support from the NIHCM Foundation.

Further reading:

Violent Death Rates: The US Compared with Other High-income OECD Countries, 2010
Handgun Regulations, Crime, Assaults, and Homicide
Firearm availability and homicide: A review of the literature
The Accessibility of Firearms and Risk for Suicide and Homicide Victimization Among Household Members: A Systematic Review and Meta-analysis
More Guns, Less Crime: Understanding Crime and Gun Control Laws
Firearms and Violence: A Critical Review. Chapter: 6 Right-to-Carry Laws
A Guide to Mass Shootings in America
Mass Murder with Firearms: Incidents and Victims, 1999-2013
PUBLIC LAW 112–265—JAN. 14, 2013

@aaronecarroll

Drugs that go through FDA’s expedited review might be better drugs

A new paper in the latest issue of Health Affairs is worth a look. “Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process“:

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999–2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes.

The FDA has a strict process for drug approval, requiring a number of phases of testing to establish safety and efficacy. It can, however, expedite this process when it thinks a drug may address an unmet clinical need. Of course, you want such a process to be fair and work. You want it to be focused on “better” and “more important” drugs. The 21st Century Cures Act moved even further. Some worry that loosening standards will lead to increased exposure to harm, especially if there isn’t proof that these drugs provide more benefits.

Enter this study:

We developed a data set of incremental QALY gains associated with drugs the FDA included in the expedited review programs and those the FDA did not include. We used drug-indication pairs as the unit of analysis. In other words, when incremental QALY data were available for a drug for multiple indications, each indication was included separately in the data set. We previously used this data set and a similar methodological approach to compare the incremental health gains associated with specialty and traditional drugs

They then identified all new molecular entities approved by the FDA from 1999-2012, separating them into those that did and did not use the expedited process.

They found that drugs that used at least one expedited review program (there are four) offered greater gains than those that did not (0.182 vs 0.003 QALYs). When they looked at the individual programs, there were differences in three of the four: priority review (0.175 vs 0.007 QALYs), accelerated approval (0.370 vs 0.031 QALYs), and fast track (0.254 vs 0.014 QALYs).

There are limitations to this, of course. Not all drugs have QALY estimates, and those without can’t be studies. To be honest, I was surprised so many did. Clearly there are some other biases here as well – positive QALY outcomes are more likely to be published and pushed, especially by industry. QALY’s also aren’t perfect, but I’m not going to fault them for using an accepted standard.

Bottom line: This is evidence that drugs in expedited programs seem to have larger QALY gains than those in the conventional process. Drugs in more programs have bigger gains. The FDA program appears to be working. That doesn’t mean we should stop looking and evaluating, but we should acknowledge the apparent success of the process.

@aaronecarroll

Healthcare Triage News: The Trump Administration Has Many Options to Undermine Obamacare

While the Senate and the House haven’t been very effective in passing a repeal of Obamacare, the ACA’s provisions are still at risk. There’s a lot that Donald Trump’s administration can do (or not do) to undermine Obamacare’s provisions and marketplaces.

@aaronecarroll

Music therapy for austism spectrum disorder: it’s murkier than you might think

Let’s start with the fact that there’s a good Cochrane review on music therapy for people with autism spectrum disorder. It included ten studies of 165 participants, all RCTs or controlled trials, that compared music therapy to placebo or standard care. Music therapy did well:

The findings of this updated review provide evidence that music therapy may help children with ASD to improve their skills in primary outcome areas that constitute the core of the condition including social interaction, verbal communication, initiating behaviour, and social-emotional reciprocity. Music therapy may also help to enhance non-verbal communication skills within the therapy context. Furthermore, in secondary outcome areas, music therapy may contribute to increasing social adaptation skills in children with ASD and to promoting the quality of parent-child relationships.

But these were small studies, and the outcomes didn’t overlap between them often, and some people still had questions.

Enter the TIME-A RCT. Just published, it’s a randomized trial of 364 kids in 9 countries. It was assessor blinded, and it had reasonably strict entry criteria. It used a widely accepted primary outcome, the Autism Diagnostic Observation Schedule (ADOS). Outcomes were assessed at 2, 5, and 12 months.

Everyone got “enhanced care”, which was usual care plus parent counseling. The intervention group also got improvisational music therapy, where trained therapists sang or played music with each child, to encourage affect sharing and joint attention.

Most of the kids (86%) completed the primary end point of 5 months, and most completed the last end point (80%). Over the primary intervention period, kids got a median 19 sessions of music therapy in addition to other care.

In the music therapy group, the ADOS social affect scores improved from 14.08 to 13.23. In the control group, they improved from 13.49 to 12.58. No difference. Of the 20 exploratory secondary outcomes, 17 showed no difference as well.

You can scream “one trial!” and you’d be right. But this one trial was larger than all the other trials put together and then doubled. You can scream that it didn’t test every type of music intervention, and you’d be right. But it was pretty pragmatic and well thought out.

Most of those previous trials were limited to one local area and one therapist. How generalizable were they? This was multicenter and multicountry.

In 2017, there were about 7000 music therapists in the US. I’m sure they won’t like these results.

The accompanying editorial is fair. It makes balanced arguments both for and against continued focus on musical therapy. I’m going to be honest and say that I fall into the “doesn’t seem to work” camp now. I say that because recognizing how common ASD is, and how important it is to intervene, I want to see time and money go to things that work, not where they might not.

Regardless, whether we do more trials in this area, or abandon music therapy is up to the ASD research and patient communities. Supporters should be pushing for more research, though, not more money to therapies that lack a good evidence base.

@aaronecarroll

NEJM: Partial Medicaid Expansions Under the ACA

Nick Bagley, Allan Joseph, and I have a new perspective piece up at the New England Journal of Medicine evaluating implications of Arkansas’s latest waiver application. Among other proposals, the state has requested to move to a “partial expansion” model, shifting the population with incomes between 100 and 138% FPL from Medicaid into the exchanges.

Multiple states proposed partial (or phased-in) expansions before the ACA’s coverage provisions took effect, but the Obama administration rebuffed these efforts.

Why were states interested in these partial expansions? Starting in 2020, states are responsible for covering 10% of the costs associated with the Medicaid expansion. Because of a drafting mistake, however, the ACA says that the 100-to-138 population can receive subsidies to purchase a private health plan on the exchanges — but only if they are ineligible for Medicaid. For those people, the federal government bears the entire cost of subsidizing private coverage, with no contribution from the states. As a result, the states save money for every beneficiary whom they can move from Medicaid into their exchanges.

Though the justification against partial expansion was legal in nature—CMS contended at the time that the ACA “does not provide for” limited or phased-in expansions—the current administration might perceive broader flexibility.

Now that repeal of the ACA’s Medicaid expansion seems unlikely, will the Trump administration allow partial expansions? Arkansas’s waiver request will force an answer to that question. Because Arkansas is already operating under a unique waiver that allows it to enroll Medicaid beneficiaries in exchange plans, partial expansion would have relatively muted effects in the state: it would just rejigger state–federal financing arrangements. Nonetheless, acceding to Arkansas’s request would set a precedent with extraordinary practical, budgetary, and political consequences.

The budget-gimmicky nature of partial expansion is laid bare in the special case of Arkansas, which already enrolls its expansion population in exchange plans, using Medicaid dollars. Moving the enrollees more formally into the exchange primarily serves to remove state dollars from the funding equation. And in service of this goal, partial expansion imposes greater cost-sharing on beneficiaries while eliminating certain Medicaid-specific protections, like presumptive and retrospective eligibility. If the administration approves Arkansas’s request, they will be hard-pressed to reject similar waivers from other states, who will see the same budgetary appeal.

You can read the whole thing here.

Waivers are a matter of administrative discretion, but widely-implemented partial expansions could prove harder to unwind than other changes sought by states. Though they were beyond the scope of our piece, Arkansas’s waiver application—as well as applications from other states—would limit Medicaid enrollment in other ways, by imposing work requirements and strictly narrowing or eliminating presumptive and retrospective eligibility. Absent further congressional action, Medicaid waiver decisions will be among the most consequential health policy developments in the coming months.

I would like to acknowledge and thank Dave Anderson of Duke University and the Balloon Juice blog, who helped me navigate 2017 premium data (from which I was able to extract cost-sharing information for plans with cost-sharing reductions). Also, for completeness: due to editorial constraints, we weren’t able to include a sixth citation for the analysis comparing exchange premiums in expansion and non-expansion states, which was published by ASPE in 2016. 

Adrianna (@onceuponA)

The Bad Food Bible – Preorder Now!

I’ve mentioned it a number of times before, but let this post be the official notice: I have a new book being published on November 7. It grew out of some of my columns over at the Upshot about food (which also happen to be some of my most popular). From the description of the book:

Advice about food can be confusing. Experts seem to only agree on one thing: some ingredients—often the most enjoyable ones—are bad for you, full stop. But as physician Aaron Carroll explains, if we stop consuming some of our most demonized foods, it may actually hurt us. Examining troves of research about dietary health, Carroll separates hard truths from sensationalized hype, showing that you can:

Eat meat several times a week: Its effects are negligible for most people, and arguably positive if you’re 65 or older.
Have a drink or two a day: In moderation, alcohol may protect against cardiovascular disease without much risk.
Enjoy a gluten-loaded bagel from time to time: It has less fat and sugar, fewer calories, and more fiber than a gluten-free one.
Eat more salt: If your blood pressure is normal, you may be getting too little sodium, not too much.

Full of counterintuitive lessons about food we hate to love, The Bad Food Bible is for anyone seeking eating habits that are sensible, sustainable, and occasionally indulgent.

You can preorder the book at any of the below:

Amazon
Barnes & Noble
Indiebound
iBooks
Google
Kobo
Any local bookstore you might frequent. You can ask for the book by name or ISBN 978-0544952560

It goes without saying that I would love for you to buy it. Preorder it so you are assured to have it on the day of publication!

@aaronecarroll

Answering questions about Medicare Advantage

Readers asked some questions about my most recent piece on Medicare Advantage. Here they are, with my answers.

1. Isn’t it true that the government pays Medicare Advantage plans a lot less today than they did in 2010, the year of focus of the study you wrote about?

Almost! According to government statistics, in 2010, Medicare Advantage plans received payments from the Medicare program equivalent to 113 percent of what it would cost a similar beneficiary to be covered by the traditional program. In 2017, that figure is 100 percent, but grows to 104 percent if you more accurately account for differences in the health of Medicare Advantage enrollees and traditional Medicare beneficiaries.

2. If the government is now paying the same (or almost the same) for an enrollee in Medicare Advantage as for a traditional Medicare beneficiary, what’s the problem?

Well, some believe that we should be taking advantage of market efficiency to save the government money, which was part of the original motivation for including private plan alternatives in Medicare. One key point of my piece was to compare what Medicare Advantage plans receive from the government to what it costs the plans to provide care, including marketing, administration, and profit as well. On that basis, in 2010, the plans received 8.5 percent more in government revenue than their costs. In 2017, that figure is 11 percent. What this means, as I wrote, is that Medicare Advantage plans are more efficient at managing care than the traditional program, but that taxpayers aren’t benefiting from that efficiency as much as they could be.

3. Where does that extra money go?

Medicare Advantage plans are supposed to use the additional revenue to enhance their benefits — either by providing coverage for things traditional Medicare does not cover (e.g., eyeglasses and hearing aids) or by reducing cost sharing. There is no doubt plans do this, as I wrote in my piece. And this is of tremendous benefit to enrollees, particularly lower income ones that cannot afford a supplemental plan to fill in the gaps in traditional Medicare.

A post on the Health Affairs blog documents in greater detail the kinds of additional benefits Medicare Advantage plans provide, beyond what’s covered by traditional Medicare. Just over half get basic dental benefits, three-quarters get eye exam coverage, just under half get a hearing aid benefit, and about one-third get help paying for gym memberships. The vast majority of Medicare Advantage enrollees that get these benefits, and others, do so with no additional premium.

But there is some doubt that plans provide additional benefits like these as efficiently as they could. Because the Medicare Advantage market is not as competitive as it might be, studies have shown that plans may pay more for benefits than they should, and enrollees receive less value from them than their costs. However, it’s also the case that the Affordable Care Act limits Medicare Advantage spending on things like marketing, management, and profit to 15 percent of revenue.

4. Isn’t it true that sicker patients tend to leave Medicare Advantage?

Yes. This is something I wrote about in another Upshot post. Because Medicare Advantage plans have networks, enrollees are not covered for just any doctor they wish. Medicare Advantage plans may also impose other restrictions on care, like requiring prior authorization for some services. For sicker patients, such practices impose a heavier burden, because they need more care and see more doctors. Some of those patients choose to leave Medicare Advantage and return to the traditional Medicare program, which has an open network and does not attempt to manage care.

5. So, given all this, what is the value of Medicare Advantage?

Medicare Advantage plans have been found to be of higher quality than traditional Medicare. They also reduce wasteful use of health care by managing care, something the traditional program doesn’t do at all. Finally, they fill in gaps in coverage and cost sharing of the traditional program. They’re able to do so when the traditional program is not because changing traditional Medicare would require legislation, and it’s hard to achieve political consensus on anything in health care these days.

The bottom line is that Medicare Advantage plans offer choices that some beneficiaries value. They can deliver the Medicare benefit more efficiently and with higher quality. Yet, taxpayers do pay more to plans than they could, given plans’ own costs. Paying less might mean plans leave the market and that enrollees get less. There are always tradeoffs.

@afrakt

Universal screening for obesity in kids makes sense, but…

The USPSTF recommends (grade B) that we screen all kids older than 6 years for obesity. Their recommendation is evidence-based and well-thought out. But it’s still a problem, says a new editorial at JAMA Internal Medicine. They have a point. As I’ve discussed before, there are four questions I always consider, which I adapted from David Sackett’s classic handbook on evidence-based medicine:

Is the condition prevalent and severe enough to warrant screening?
Do we have a cost-effective means to screen the general population?
Does early diagnosis make a difference (that is, do we have treatments available that are more successful when patients are diagnosed earlier?)
Will an early diagnosis motivate people to use information gained from screening?

(1) and (2) are no-brainers. Obesity is prevalent, and it’s super-cheap to measure. The problems kick in with (3) though. Even (4) is a problem, as it’s hard to imagine that telling people they’re obese is what makes a difference in their doing something to help. From the editorial:

The benefit of treatment for obesity is clear… The specific treatments recommended are “comprehensive, intensive behavioral interventions” that are multicomponent and incorporate activities such as counseling children and their families regarding nutrition, physical activity, and techniques to help change behavior through self-monitoring, goal setting, and problem solving. Based on growth in the evidence base, including the quality of studies, the recommendations are more far-reaching and specific than in 2010. For the 2017 recommendation, the USPSTF incorporated results from 42 trials with multicomponent behavioral interventions involving nearly 7000 children. These trials included 8 rated as “good quality.” However, only about one-quarter of these studies included adolescents, limiting inferences about this group. Screening is still recommended, using age- and sex-specific BMI, as are obesity treatment programs that provide at least 26 contact hours; contact hours were calculated based on the number and length of intervention sessions. Evidence points to a dose response of treatment, with the greatest success achieved by programs with at least 52 contact hours (7 trials tested interventions of this length). These longer-duration programs have clear evidence of improvements in weight status and some related cardiometabolic risk factors after 6 or 12 months of follow-up. The findings on cardiometabolic risk factors are notable considering that sustained improvements early in life will likely have long-term benefits in preventing diabetes and metabolic diseases in adulthood.

Who is going to pay for these interventions? How will we get people the support they’ll need to get kids to them? Who will actually do these interventions on a nationwide scale? All important questions, and we continue to talk about raising cost-sharing and skimping back on benefits, I doubt that these programs will be top of the list for plans.

It’s not enough to screen point out the problem. We also have to have solutions available to people once we’ve told them they need to do something.

We also could massively focus on prevention, which might make a lot of this moot.

@aaronecarroll

Medicare Advantage plans spend less on care than traditional Medicare, but are paid more for it

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

The Medicare Advantage program was supposed to save taxpayers money by allowing insurers to offer older Americans private alternatives to Medicare. The plans now cover 19 million people, a thirdof all those who qualify for Medicare. Enrollee satisfaction is generally high, and studies show that plans offer higher quality than traditional Medicare. But the government pays insurers more than they pay out for patient care — in some years, it turns out, a great deal more.

Concern about Medicare Advantage’s cost has found sharp expression in a recent suit brought by the Justice Department charging UnitedHealth with excessive billing of the government. While that suit plays out, research published by the National Bureau of Economic Research provides context.

The study, released in January, found that the revenue Medicare Advantage plans received in 2010 exceeded the amount they paid out for medical care by a hefty 30 percent. At more than $2,000 per enrollee per year, that probably topped $20 billion dollars, nearly all from federal payments, not enrollee premiums. The study relied on Medicare Advantage billing data obtained from three large insurers across 36 states, a type of data the government doesn’t yet release.

Paradoxically, even though Medicare Advantage plans cost taxpayers more than traditional Medicare, they spend less on care. In fact, one of the motivations of the program is to capture that lower spending as savings for taxpayers. It hasn’t worked out that way.

“Our study found that health care spending for enrollees in Medicare Advantage plans is 10 to 25 percent lower than for comparable enrollees in traditional Medicare,” said Amy Finkelstein, an M.I.T. economist and one of the study’s authors. “Yet government payments to plans is far above their lower health care costs.” The study was also conducted by four economists at Stanford: Vilsa Curto, Liran Einav, Jonathan Levin and Jay Bhattacharya.

The analysis raises two questions: How do Medicare Advantage plans spend so much less on care? And, given that, how do we account for their higher costs to taxpayers?

One reason for the lower spending is that Medicare Advantage enrollees use less care or use lower-cost care. For example, compared with traditional Medicare patients, Medicare Advantage patients are more likely to go home after a hospital visit, rather than to a skilled nursing facility. Medicare Advantage patients see specialists relatively less often and receive fewer inpatient operations, but more outpatient ones, which are cheaper. All of these are what you’d expect from care management techniques used by Medicare Advantage: referral requirements and narrow networks of doctors, for instance.

Previous studies have also shown that Medicare Advantage enrollees use less of some kinds of care, including hospital care, versus traditional Medicare beneficiaries.

“This is exactly what Medicare Advantage plans were designed to do,” said Dr. Bruce Landon, a physician with Harvard Medical School. “They manage the utilization of services while also assuring that enrollees receive recommended care, all at lower cost to patients.” Dr. Landon’s research on the program found that Medicare Advantage enrollees use 20 percent to 30 percent less emergency department and outpatient surgical care, as well as receive fewer hip and knee replacements.

Medicare Advantage plans also attract enrollees who tend to be healthier than traditional Medicare beneficiaries, a feature that yielded intriguing results in light of the lawsuit against UnitedHealth. When the M.I.T.-Stanford team compared the two kinds of Medicare patients, they found that Medicare Advantage patients were 25 percent less costly than traditional Medicare patients. But when the team more rigorously matched the health of both sets of patients, the Medicare Advantage patients were just 10 percent less costly. This drop does not prove the suit’s claims of overbilling, but it allows for the possibility.

Why does the government pay Medicare Advantage plans so much more than it costs them to cover care? It’s partly an intentional, if controversial, design of the program. Congress has established payment formulas and authorized bonus programs intended to help the private market.

The government also pays insurers for administrative and marketing expenses. Yet even when these additional expenses are factored in, the government still pays plans an excess. According to the Medicare Payment Advisory Commission, federal payments to the plans exceeded health care costs and other expenses by 8.5 percent in 2010. Though the Affordable Care Act has reduced payments to plans and limits the amount they can attribute to administration and marketing, they still receive government payments in excess of their costs today.

Not all of the “excess” federal money goes to the insurers’ bottom line. Traditional Medicare entails significant cost sharing for beneficiaries; they are responsible for 20 percent of the costs of doctors visits, for example. Most Medicare Advantage plans don’t require as much cost sharing or out-of-pocket payments. And some of the influence of Medicare Advantage plans’ managed care techniques rub off on the traditional program, too, reducing spending — a spillover effect that partly explains the slowdown in growth of Medicare spending.

But is the cost of Medicare Advantage worth the benefits it delivers? It’s hard to know without knowing more about patients’ diagnoses, services used and other data. The Medicare program had been collecting such data since 2012 and was planning to release it, but, expressing concerns about its quality, recently put off doing so.

@afrakt

So much for hypertonic saline for bronchiolitis…

I thought I’d blogged on it, but I can’t find the post. Maybe I dreamed it. Anyway, a couple years ago, people were touting hypertonic saline as a potential therapy for kids with bronchiolitis. They had evidence.

Short side note here: Bronchiolitis is a lower airway infection, often caused by RSV, that can be bad for infants and toddlers. We don’t have much we can do for them other than supportive care. The vast majority of kids get better on their own. Some people recommend bronchodilators, but I spent most of my early training and career railing against such people, cause the evidence says they don’t work well, and they have side effects. In fact, I probably had more fights about bronchiolitis in residency than any other topic. Except wedges. And, later, D’Allergy. That’s a topic for another day, though.

In 2016, a re-analysis of 2 meta-analyses threw some cold water on the hopes for hypertonic saline. Researchers argued that outliers and unbalanced treatment groups were responsible for the positive results. And then, this month, JAMA Pediatrics just published a large randomized controlled trial that might help settle the debate.

They randomized 777 healthy infants to get nebulized hypertonic saline (3%) or normal saline (0.9%) in the Emergency department. This was multicenter, multi-season, in France. The outcome of interest was the admission rate to the hospital.

They found that 48% of those getting hypertonic saline were admitted compared to 52% of kids getting normal saline. The differences were not statistically significant. There were also more mild adverse events, like cough, in the hypertonic saline group.

So… no real benefit and some minor harm. The accompanying editorial was entitled, “Could This Be the Last Word on Hypertonic Saline?” Given my previous experience with failed treatments for bronchiolitis, I’d answer, “no”, but maybe we’ve learned since then.

@aaronecarroll