Aaron E. Carroll's Blog, page 61

Alcoholics Anonymous vs. Other Approaches: The Evidence Is Now In

The following originally appeared on The Upshot (copyright 2020, The New York Times Company)

For a long time, medical researchers were unsure whether Alcoholics Anonymous worked better than other approaches to treating people with alcohol use disorder. In 2006, a review of the evidence concluded we didn’t have enough evidence to judge.

That has changed,

An updated systematic review published by the Cochrane Collaboration found that A.A. leads to increased rates and lengths of abstinence compared with other common treatments. On other measures, like drinks per day, it performs as well as approaches provided by individual therapists or doctors who don’t rely on A.A.’s peer connections.

What changed? In short, the latest review incorporates more and better evidence. The research is based on an analysis of 27 studies involving 10,565 participants.

The 2006 Cochrane Collaboration review was based on just eight studies, and ended with a call for more research to assess the program’s efficacy. In the intervening years, researchers answered the call. The newer review also applied standards that weeded out some weaker studies that drove earlier findings.

In the last decade or so, researchers have published a number of very high-quality randomized trials and quasi-experiments. Of the 27 studies in the new review, 21 have randomized designs. Together, these flip the conclusion.

“These results demonstrate A.A.’s effectiveness in helping people not only initiate but sustain abstinence and remission over the long term,” said the review’s lead author, John F. Kelly, a professor of psychiatry at Harvard Medical School and director of the Recovery Research Institute at Massachusetts General Hospital. “The fact that A.A. is free and so widely available is also good news.

“It’s the closest thing in public health we have to a free lunch.”

Studies generally show that other treatments might result in about 15 percent to 25 percent of people who remain abstinent. With A.A., it’s somewhere between 22 percent and 37 percent (specific findings vary by study). Although A.A. may be better for many people, other approaches can work, too. And, as with any treatment, it doesn’t work perfectly all the time.

Rigorous study of programs like Alcoholics Anonymous is challenging because people self-select into them. Those who do so may be more motivated to abstain from drinking than those who don’t.

Unless a study is carefully designed, its results can be driven by who participates, not by what the program does. Even randomized trials can succumb to bias from self-selection if people assigned to A.A. don’t attend, and if people assigned to the control group do. (It may go without saying, but we’ll say it: It would be unethical to prevent people in a control group from attending Alcoholics Anonymous if they wanted to.)

Despite these challenges, some high-quality randomized trials of Alcoholics Anonymous have been conducted in recent years. One, published in the journal Addiction, found that those who were randomly assigned to a 12-step-based directive A.A. approach, and were supported in their participation, attended more meetings and exhibited a greater degree of abstinence, compared with those in the other treatment groups. Likewise, other randomized studies found that greater Alcoholics Anonymous participation is associated with greater alcohol abstinence.

Alcoholics Anonymous is often paired with other kinds of treatment that encourage engagement with it. “For people already in treatment, if they add A.A. to it, their outcomes are superior than those who just get treatment without A.A.,” said Keith Humphreys, a Stanford University professor and co-author of the new Cochrane review.

Alcoholics Anonymous not only produced higher rates of abstinence and remission, but it also did so at a lower cost, the Cochrane review found. A.A. meetings are free to attend. Other treatments, especially those that use the health care system, are more expensive.

One study found that compared with Alcoholics Anonymous participants, those who received cognitive behavioral treatments had about twice as many outpatient visits — as well as more inpatient care — that cost just over $7,000 per year more in 2018 dollars. (Cognitive behavioral treatments help people analyze, understand and modify their drinking behavior and its context.)

Another study found that for each additional A.A. meeting attended, health care costs fell by almost 5 percent, mostly a result of fewer days spent in the hospital and fewer psychiatric visits.

A.A. meetings are ubiquitous and frequent, with no appointment needed; you just show up. The bonds formed from the shared challenge of addiction — building trust and confidence in a group setting — may be a key ingredient to help people stay on the road to recovery.

Worldwide, alcohol misuse and dependence are responsible for 3.3 million deaths per year, 10 times the number of fatalities from all illicit drugs combined.

In the United States, alcohol is a larger killer than other drugs; accounts for the majority of all addiction treatment cases; and is responsible for at least $250 billion per year in lost productivity and costs related to crime, incarceration and health care. Moreover, American deaths related to alcohol more than doubled between 1999 and 2017.

Reducing the human and financial burdens of alcohol is an often overlooked public health priority, and the new evidence suggests that on balance one of the oldest solutions — Alcoholics Anonymous has been around almost 85 years — is still the better one.

@afrakt     @aaronecarroll

 

What should you do about COVID-19? Talk to your people

If you are a TIE reader, you likely share the view that there is a real chance that the COVID-19 pandemic will cause substantial deaths, and soon. It’s not a certainty, but it’s a risk that cannot be ignored. Some of these deaths can be averted through immediate and sustained preventive actions, including social distancing. I want to persuade you that you should talk to people who matter in your community about what we are facing and what we have to do.

What we are facing is the possible exponential growth in the number of cases in North America in the next few weeks. Among the fears is that the growth will exceed the capacity of the health care system to adequately care for them. There may be too many cases for the available ICU beds and ventilators, in which case many severely ill patients will die. There are some hopeful signs: in China and Korea, the number of new cases is falling. This is almost certainly true in part because these countries have implemented stringent measures to reduce the person-to-person transmission of the virus.

Unfortunately, comprehensive preventive actions aren’t happening yet in North America. On our side of the Pacific, there may never be a central authority that can or will implement the massive interventions that the Chinese and Koreans have. Or they will do it much later than they should. But every chain of transmission that is broken reduces the number of people who eventually become infected and how quickly that number accumulates. So, in the absence of leadership, action and change have to be local here. What each of us needs to do is to act locally to promote preventive social distancing where we live among the people to whom we are connected.

This came home to me in church three weeks ago. I belong to an Anglican (in the US, you’d say Episcopal) parish that celebrates holy Eucharist from a common chalice every Sunday. Before that happens, we share God’s Peace, which means we shake hands or hug everyone in reach. That Sunday, as we stood to greet each other, it was as if I was waking from a dream. “This is how it happens, right here.” I crossed my arms across my chest and mumbled something about having a cold. After the service, I corralled our priest and spoke about my concerns. He had been thinking along the same lines. But it’s a challenging issue: the Peace and the Eucharist are of immense importance to our community. This conversation led to my getting pulled into an ongoing discussion with the diocesan clergy about what we should do. (We’re changing, and the policies are evolving quickly.)

My point is that you are engaged in local institutions that need to change to reduce the transmission of COVID-19. This change may have to originate from within these institutions. And you will know someone– maybe the youth hockey coach, or the school principal – who is central to that social network. It would help if you reached out to them. This person will likely know, better than you, what questions need to be answered and what words need to be said to make change happen. And, if your experience is like mine, they will be grateful for your knowledge about the epidemic. They’re not on #epitwitter.

As it happens, I had coffee with my priest this morning. Part of what we talked about was what may happen if (when?) social distancing falls short of reducing the growth of the epidemic to levels of cases that the health care system can handle. I shared the reports that some Italian hospitals are triaging access to ventilators. Canadians live with an assurance that, in emergencies, the health care system will be there for them. No one in this culture is ready for the trauma of being told that they or a family member is at mortal risk but cannot get the necessary care.

Lots of people outside the health care system should begin to think now about how to address the consequences of this phase of the epidemic if, God forbid, we get there. So far as I can tell, this is not, to say the least, on the radar of local clergy. But they are essential psychological caregivers, if often unrecognized. If things go badly, these clergy will be deeply engaged in the care of the bereaved.

So will many others. If you get what is happening with COVID-19, and you are connected to people in your community who can make a difference, buy them a cup of coffee. And talk.

Coronavirus Highlights the Pitfalls of Health Deductibles

The following originally appeared on The Upshot (copyright 2020, The New York Times Company)

 

Much of the care provided in the United States is unnecessary or too expensive. Cost sharing is one way to try to push patients to be more thoughtful consumers of medical care. The blunt way we use it, however, often does more harm than good.

Cost sharing is a blanket term for things like deductibles, co-payments and co-insurance. If patients are spending money “out-of-pocket” — their own money — they might think harder about whether care is worth it.

Recent news has highlighted one aspect of cost sharing in the United States that seems to make little sense: the notion of making it start over each year. Because of the way deductibles work, you pay them in the early months of the year, when the flu (and now coronavirus) are hitting.

Since few people have met their deductible yet, many will think twice about getting care now — right when the medical community most wants them to. Recognizing this, Gov. Andrew Cuomo recently announced that New York insurers should waive cost sharing for coronavirus testing. But his powers apply only to Medicaid, where cost sharing is already minimal. Those who have private insurance through their jobs or Medicare — which is most people and also those people (older Americans) who tend to be at highest risk — are under federal regulation.

Craig Garthwaite, director of the health care program at the Kellogg School of Management at Northwestern, says the biggest problem is that we don’t discuss often enough what we’re trying to accomplish: “There are two main reasons to consider cost sharing to be efficient. First, we might dissuade excess use of care, and second we might move people across products to more cost-effective options. Otherwise, we are just decreasing the benefits of insurance.”

There’s plenty of evidence on the amount of excess care. A study in PLOS One in 2017 asked doctors across the country how much care they thought people received that wasn’t necessary. They reported that more than 20 percent of it wasn’t. They thought that more than 10 percent of procedures, more than 20 percent of prescriptions and about a quarter of tests weren’t needed. A review of the literature in JAMA last year estimated that overtreatment or low-value care was responsible for $75 billion to $100 billion in waste a year.

Of course, none of those things happen without a doctor’s permission. Maybe we need patients to help in saying no.

But it turns out that patients aren’t very good at differentiating between necessary and unnecessary care. This isn’t entirely their fault. If there aren’t enough in-network specialists available, for instance, all the monetary incentives in the world can’t make patients choose more wisely.

Further, some care is clearly necessary. When expert panels deem something worthy of universal screening, for instance, it seems odd — not to mention counterproductive — to then put up barriers to obtaining it. Doctors don’t want patients to second-guess the decision to get these screenings. We want everyone to do it.

That was one of the main reasons that, as part of the Affordable Care Act, all screening with an A or B rating from the United States Preventive Services Task Force would be free without cost sharing. When it’s deemed necessary for everyone, all barriers are removed.

In many other facets of necessary care, though, the U.S. system isn’t nearly as thoughtful. When people have asthma, for instance, and they’re told they need a preventive steroid inhaler, that care is not “optional.” Doctors are not looking to have anyone question whether it’s worth “their money” versus an insurance company’s money. We want them to get and use the inhaler.

The same holds true for many chronic conditions. People with high blood pressure must take their medication — likewise, people with sickle cell disease, ulcerative colitis and, of course, cancer. When cost sharing is imposed for these diseases, the evidence suggests it leads fewer patients to take their drugs, which leads to worse outcomes.

In no disease is this clearer and more prevalent than diabetes. People with insulin-dependent diabetes, especially Type 1 diabetes, must take their medication, often many times a day, or they risk serious complications or even death in a very short period.

This is where the second reason to use cost-sharing comes into play. Perhaps there are cost-effective options for insulin. In that case, making sure one of them is available for low or no cost seems a good idea.

As things are set up now, when we look for care, there are usually almost no options available with low or no cost sharing. Everything costs money out of pocket, no matter what insulin you choose.

Alternatively, the system could recognize that some diseases or conditions need more care, not less. For these cases, cost sharing could be eliminated or significantly reduced.

In France, people with 32 specific chronic illnesses (making up 13 percent of the population) are exempt from co-payments for treatments for those diseases. In England, cost sharing is minimal, but even so it’s waived for people with cancer and other long-term conditions. In Germany, those with chronic conditions have their cost sharing capped at half the level of others.

In these countries, the percentage of people 55 and over who skip doses of drugs is much lower than in the United States. (People often skip doses because of the cost.)

One idea would be to change the types of cost sharing to be more strategic. Deductibles, for instance, make much less sense than co-payments or co-insurance. Deductibles just try to make people second-guess their spending, no matter what it’s on.

A better model might target people who choose high-cost options, increasing their cost sharing. Under a reference pricing system, for instance, insurers commit to pay the full cost for some lower-cost (but high-quality) care, and patients must pay the difference if they decide to go to providers that cost more.

“Reference pricing is smarter cost sharing because it puts the pressure not on the use of the service, but on the choice of a high-cost facility,” Mr. Garthwaite said. “In this way, it is less likely to decrease necessary care while still controlling costs.”

Cost sharing — which would be eliminated in Bernie Sanders’s “Medicare for all” proposal — isn’t inherently bad. But right now, it doesn’t appear to have a clear purpose, and the novel coronavirus reminds us how urgent a matter this can be. We seem to be getting all the harm without reaping much benefit.

@aaronecarroll

 

Make vaccines and drugs to treat coronavirus accessible to all

The following is a guest post by Rena Conti and Joshua Sharfstein. Rena M. Conti is a health economist and the Associate Research Director of Biopharma & Public Policy for the Boston University Institute for Health System Innovation & Policy. She is also an Associate Professor at the Boston University Questrom School of Business. (Email: rconti@bu.edu; Twitter: @contirena1 @BU_ihsip @bu_hsm.) Joshua M. Sharfstein, MD, is Vice Dean for Public Health Practice and Community Engagement at Johns Hopkins Bloomberg School of Public Health. He also holds a faculty appointment in the Department of Health Policy and Management. Previously, he served as the Secretary of the Maryland Department of Health and Mental Hygiene, the Principal Deputy Commissioner of the U.S. Food and Drug Administration, as Commissioner of Health for Baltimore City, and as health policy advisor for Congressman Henry A. Waxman. (Email: joshua.sharfstein@jhu.edu; Twitter: @drJoshS)

As Americans learn to protect themselves from respiratory infection by coughing into their sleeves and washing their hands well, the federal government and the private sector are investing heavily in the development of safe and effective vaccines and medications targeting the novel coronavirus.

It is not too early to ask the question of how best to make available and fund these products.

One approach is to let the health care system determine price and access.  In 2019, new medicines were commonly priced at about $20,000 per course of treatment, with some priced higher.  New vaccines are commonly priced at about $200 per course of treatment. While insurers pay the majority of these costs, increasingly Americans are being asked to pay some or even all of the costs out-of-pocket through co-pays.  As a consequence, patient access and adherence to treatment suffers.

There are four problems with letting the market determine who gets vaccinated and treated for coronavirus in the midst of an epidemic.  First, with no alternatives and many patients desperate for care, we could place our hope in pharmaceutical companies pricing their products responsibly.  Yet, there are no tools in place to tame their pricing power available immediately if needed.  Second, even with insurance, the out of pocket cost to access these products may be unaffordable for millions of Americans, not to mention for billions of low-income people around the world.  Third, limited access will mean that the virus will keep spreading, inhibiting economic and social recovery at home and abroad.  Fourth, and most importantly, it’s not ethical or equitable to determine life and death based on ability to pay.

Fortunately, there are smarter ways to proceed. The goals should be expediting access for all who need these products at a reasonable cost.

There are two alternative paths to consider.

One approach is for government to purchase products when they become available for those without health insurance. This is the approach taken for childhood vaccines.  However, this would not address access or affordability for those who have some ability to pay in the US and would not address global need for care.

To address this challenge, a related approach is to purchase products when they become available intended for all domestic and global payers. The awarding of ‘prizes’ for the development of new vaccines or therapeutics falls under this approach (see this recent TIE post).

However, a limitation of this approach is that pharmaceutical companies may be reluctant to develop products if they know they will not get paid for their costs if and when the crises subsides.  This approach may also not foster innovation in how best to meet the unmet need by awarding the first product to market, not necessarily the best.  Both result in delays to getting effective products to the people most in need.

A second approach is an advanced market commitment. Under an advance market commitment, the US government and other payers commit to a minimum price to be paid per person up to a certain number of individuals immunized or treated. The price would be set to cover at a minimum the product’s development and manufacturing costs. For additional purchases, the price would eventually drop to close to their incremental manufacturing costs.

Advanced market commitments can set safety and quality standards for a product to meet. If no suitable product were developed, no payments would be made. However, if a company was successful in making the product and the immediate need for the product subsides they would still be rewarded.  With an advanced market commitment, subsequent improvements in the product or additional products to aid the effectiveness of the first can also rewarded by splitting the commitment or adding additional payments.

We believe pursuing a coronavirus advanced market commitment is the most fruitful approach to addressing the current crisis and would set an important precedent for the development of therapeutics to address other unmet medical needs.

To start, policymakers should convene discussions with physicians, public health experts, payers and regulatory agency directors to structure the terms of the advance market commitment under current statutory authority. To help identify best practices, policymakers should include the voices of experts who have already successfully pursued advanced market commitments to prevent or mitigate disease, including the Global Fund for HIV/AIDs and the Gates Foundation.  Lastly, innovators engaged in a broad array of approaches to prevent and treat infectious disease and its consequences should be engaged in this process. A coronavirus advanced market commitment should ensure the products targeted are broad enough to address global unmet need, including vaccines, antiviral and antibacterial therapeutics, other products to support the immune function of persons affected and diagnostics to support the effective use of products to prevent and treat infection.

Coronavirus Update

The spread of the new Coronavirus has continued, with a number of cases showing up in countries like Iran, Italy, and South Korea. Coronavirus information is changing by the minute, so we’re back with another update.

 



@DrTiff_

Express Lane Eligibility, a missed opportunity to patch holes in the safety net?

Paul Shafer is an assistant professor of health law, policy, and management at the Boston University School of Public Health. He tweets at @shaferpr.

We spend a lot of time debating who should be eligible for public assistance and how generous it should be. But we spend a lot less time on how we get those who are eligible into the programs they qualify for. You can be dropped from Medicaid for missing a single letter, an example of the precarious nature of our ‘safety net’.

The introduction of the Marketplace gave states a reason to update their enrollment infrastructure, all states now accept online applications for Medicaid and nearly all able to determine eligibility in real-time (within 24 hours). However, that doesn’t solve the problem of getting people to apply or keeping them from dropping out when they are still eligible, which has historically been a big problem

An underused and poorly studied provision of the 2009 law reauthorizing the Children’s Health Insurance Program (CHIP) is called Express Lane Eligibility (ELE). It gives states the authority to use information from other public programs, like Supplemental Nutrition Assistance Program (SNAP), Temporary Assistance for Needy Families, and others, for determining eligibility for Medicaid and CHIP coverage for kids. The authority was extended through fiscal year 2027 in the Bipartisan Budget Act of 2018.

This sounds like an obvious thing to do, but states previously did not have the authority to use data from other agencies to make enrollment determinations for CHIP and Medicaid. For example, if states could use income tax data, then there would be no need to prove income or lack thereof for eligibility purposes. This makes intuitive sense, a way to make it easier for applicants and more efficient for the state.

California passed a version of ELE back in 2001, with local philanthropies funding a pilot to link the National School Lunch Program and Medi-Cal in seven school districts from 2003 to 2006. The state struggled with data matching and when combined with already high Medi-Cal enrollment rates, about half of ELE applications generated were for children already enrolled. There were also concerns that worries about immigration issues led to families not completing the simplified application. Though implementation was problematic, the authors of the evaluation concluded that a ‘”no wrong door” approach to health care’ still held promise.

Congress gave states a lot of latitude in how to implement ELE with lots of policy options available to enroll the one in five children who were eligible for CHIP or Medicaid but unenrolled and to keep them enrolled. So what happened? Only 14 states are currently using it, and they are all doing so in different combinations of programs. Some for CHIP, some for Medicaid, only four for both and a lot of variation in which programs or agencies they ‘talk’ to for ELE.

Unfortunately, we don’t know very much about the consequences of states’ ELE implementation. I only found only a handful of commissioned reports and four papers in peer-reviewed journals that rigorously evaluate ELE.

A report commissioned by the Department of Health and Human Services (HHS) found that across the adopting states, ELE increased enrollment by about 6% and saved millions of dollars in administrative costs. By analyzing each state’s implementation as a separate case study, the report found that ELE increased retention of those eligible and reduced administrative burdens on state social service agencies.

South Carolina had ranked 45th in health insurance coverage for low-income children before its ELE program was implemented in 2011. Afterwards, it helped enroll another 92,000 children and keep 276,000 on CHIP and Medicaid. The Louisiana experience shows why automation is so important. It was the first state to implement the automatic enrollment option for ELE, sending out more than 20,000 Medicaid cards in 2010 alone. Then, it switched to an ‘opt-in’ approach via a checkbox on the SNAP application, which resulted in a 62% drop in monthly Medicaid enrollment through ELE.

A study published in 2014, whose authors were part of the HHS-funded evaluation team, echoed the enrollment findings of the commissioned reports. They found that ELE was associated with a 5.6% increase in Medicaid and a 4.2% increase in combined CHIP and Medicaid enrollment. Their results also suggest that this effect may get stronger in the long-run. Another study from 2014, from authors also part of the HHS evaluation team, noted children enrolled via ELE used care less and less intensively, and were therefore less expensive to cover.

Massachusetts incorporated ELE for Medicaid renewals for parents and the expansion population, finding that “ELE participation was the strongest predictor of continuous coverage during the 90-day period following MassHealth annual review”. The rate of coverage loss within 90 days of review was more than ten times higher in the non-ELE household group (34%) than in the ELE group (2-4%). Though ELE was initially conceived as a way to reduce the number of uninsured children, using the same process and data infrastructure for the adult population not surprisingly also increases retention in Medicaid.

Under the Trump administration, we have seen the number of uninsured children jump by 400,000 and proportion of adults who are uninsured or avoided health care due to cost inch upwards. SNAP is also increasingly hard to get, with hundreds of thousands of food insecure families kicked off the program. A nationwide embrace of ELE coupled with a streamlining of the eligibility criteria for certain programs could go a long way towards helping low income populations stay healthy, housed, and fed.

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Jama Forum: Looking for Solutions to Rein in Surprise Medical Bills

A “surprise medical bill” describes the situation when a patient receives a bill for medical services that is much higher than he or she expected because it reflects some part of the treatment process that was not part of their insurer’s coverage. When you hear about a shockingly high bill for a treatment in the news, it is almost always because of this.

So what are some potential solutions to this common problem? Read the rest here!

@aaronecarroll

Healthcare Triage Podcast. Know Thyself: Precision Genomics and Pediatric Cancer

On this episode of the Healthcare Triage podcast, Aaron is talking to Dr. Karen Pollok and Dr. Jamie Renbarger about their research into the treatment of osteosarcoma and other pediatric cancers using personalized medicine. You’ll learn about the development of cell lines and creation of models that can be used to battle cancers. We’ll also hear about the experiences of one patient, Tyler Trent, who wondered about how the tissues he contributed to the research were used, and whose curiosity and willingness to share what he learned with the public has helped raise awareness of this kind of treatment.

 

 

The Healthcare Triage podcast is sponsored by Indiana University School of Medicine whose mission is to advance health in the state of Indiana and beyond by promoting innovation and excellence in education, research and patient care.

IU School of Medicine is leading Indiana University’s first grand challenge, the Precision Health Initiative, with bold goals to cure multiple myeloma, triple negative breast cancer and childhood sarcoma and prevent type 2 diabetes and Alzheimer’s disease.

Available wherever you get your podcasts! Including iTunes

@DrTiff_