Aaron E. Carroll's Blog, page 145

The mystery of back surgery’s variable popularity

The following originally appeared on The Upshot (copyright 2017, The New York Times Company). It was jointly authored by Austin Frakt and Jonathan Skinner. It also appeared on page A3 of the February 14, 2017 print edition. Click through to the original post to see a video of changes in geographic variation in back surgery rates over time.

You might think that once drugs, devices and medical procedures are shown to be effective, they quickly become available. You might also think that those shown not to work as well as alternatives are immediately discarded.

Reasonable assumptions both, but you’d be wrong.

Instead, innovations in health care diffuse unevenly across geographic regions — not unlike the spread of a contagious disease. And even when studies show a new technology is overused, retrenchment is very slow and seemingly haphazard.

Back surgery is a great example. In the early 1990s, when John Wennberg’s Dartmouth Atlas of Healthcare first started tracking treatment rates among older Medicare users, back surgery was relatively uncommon; 1992 rates were as low as one case per thousand in cities as diverse as New York and Johnson City, Tenn.

By 2006, average rates of back surgery had increased to 4.9 per thousand. The procedure had spread rapidly across the Northern Plains and Mountain States. Growth was especially significant in certain cities elsewhere — like Lubbock and Harlingen, Tex. Yet rates in New England and some parts of the Midwest had barely budged.

Even as back surgery’s popularity as a treatment for back pain began to rise in the 1990s, there was little solid evidence of its effectiveness. It wasn’t until 2006 that the first large randomized trial on the subject was published.

That study showed relatively modest benefits of surgery for many conditions that lead to back pain. While many patients felt better after a year, so did a nearly equal proportion of people in the control group who didn’t have surgery. However, years before that evidence was available, some regions had adopted back surgery at a high rate, while others had not.

The rates of back operations performed in hospitals began to flatten after 2006, but little was known about growth in the treatment in outpatient clinics, the same-day facilities with greater convenience and lower costs. Recently, Brook Martin and Sandra Sharp, two Dartmouth researchers funded by the National Institute of Aging, tracked outpatient as well as inpatient procedures through 2014. The finding: Rates of Medicare back surgery had grown 28 percent since 2006, with no decrease in regional variations; rates in 2014 ranged from 3 per 1,000 in the Bronx to 11.5 per 1,000 in Casper, Wyo.

The puzzling thing is why back surgery became more popular in certain broad regions, but not in others. Why, for example, did rates grow so rapidly in the Northern Plain states while rates in New England barely budged?

Our best guess comes from a study by Harvard and Dartmouth researchers, not on back surgery, but on cardiac treatments. It found that regional variation in Medicare spending is associated with variation in physician preferences for intensity of cardiac treatments, and to a greater degree when the evidence is ambiguous. Patient preferences exerted almost no influence. It’s likely that the pattern holds for back surgery, too, though it has not been studied in the United States.

It’s tempting to conclude that there are simply regions where the intensity of care of all types is higher — that some regions invest in all of the latest shiny technologies, while others don’t. This is too simple; Miami and McAllen, Tex., the two most expensive regions in the United States for overall Medicare spending, also clock in with among the lowest spine surgery rates. Instead, we see what Mr. Wennberg calls a surgical signature: Casper Wyo., has the highest back surgery rate in the country, but its cardiac bypass surgery is well below the national average.

This puzzling pattern once again points toward idiosyncratic physician beliefs. Orthopedic surgeons in a particular hospital may be more aggressive, while the cardiologists there are less so.

Though we can’t say this is the answer with 100 percent certainty, we can rule out some other explanations. One is how much surgeons are paid. Since Medicare pays the same price for the procedure (adjusted for cost of living) across the country, prices can’t explain the paradox. The high rates in Denver could also be explained by back pain sufferers who flock to star surgeons and well-known hospitals there, but this doesn’t hold water either. The way the statistics are compiled, if a medical tourist traveled from Des Moines to Denver, the Medicare record keepers would assign that operation back to the tourist’s home in Iowa.

Maybe it’s differences in health. Perhaps areas with rapid growth in back surgery were those where more people had back pain. Yet northern New England retirees had similar histories of hard physical labor in farming, lumbering and manufacturing, and were no more affluent than their counterparts in the Northern Plains states.

Another explanation might be that patients prefer surgery in some regions of the country. One study observed large variations in back surgery across small regions in Ontario, but these weren’t explained by patient preferences. That study, like others, found physician beliefs about the benefits of surgery were associated with surgical variations.

If physicians are driving back treatment choice, even for procedures not supported by evidence, what can be done? One approach is to provide patients with unbiased information about the potential benefits and risks of back surgery relative to nonsurgical therapy so they can make informed choices. But the concern remains that for people in intense pain, when the doctor says that “I get good results with surgery, and my patients generally feel much better,” the back surgery option, with little out-of-pocket cost, will be hard to resist.

Another option is for hospitals or insurance companies to audit outlier physicians, as in a recent example of a back surgeon with a pattern of unusually high billing. In his audit, nine of 10 procedures were deemed not medically necessary.

A third option is to push people toward high-quality back surgery centers. Walmart created a network of high-quality spine centers for its employees that includes Virginia Mason Hospital in Seattle and the Mayo Clinic. It charged hefty co-payments to anyone getting surgery outside the network. The company found about a third of referrals didn’t need back surgery.

Often discussed, the big challenge in health care is to reduce spending by cutting wasteful care. It seems just as important, though, not to let more waste creep in as it did with back surgery. Once it spreads widely, it’s very hard to undo.

AcademyHealth: Adverse drug events

Adverse drug events are a big deal, impacting half of hospital stays for adults 65 years old and older. My latest AcademyHealth post covers some of the other stats and issues.

@afrakt

 

Healthcare Triage: What We Know about Pot in 2017

Marijuana! You guys always want to know more about pot from Healthcare Triage. It’s also one of the most controversial and complex subjects we cover. And it’s time for an update on what we know, versus what we think, when it comes to the drug.

That’s the topic of this week’s Healthcare Triage.

Here’s the study itself.

@aaronecarroll

A congressional inquiry into orphan drugs

In response to a scathing report by Kaiser Health News, Senator Charles Grassley has announced an inquiry into the exorbitant prices for orphan drugs. Now seems like a good time to re-up my series on how to think straight about orphan drugs:

Background on orphan drugs and the Orphan Drug Act
Has the Orphan Drug Act worked?
The costs of the Orphan Drug Act.
Gaming the Orphan Drug Act, Part 1.
Gaming the Orphan Drug Act, Part 2.
The Orphan Drug Act’s enormous tax incentives.

As a bonus, I’m also linking to a short, draft paper on orphan drugs that I compiled during my stint at the World Health Organization. It hasn’t found a home yet, but I’ll try to get it published soon. (Comments are welcome.) Here’s the takeaway:

Some orphan drugs are immensely valuable, but many of the most valuable would have been developed even in the absence of orphan drug legislation. At the same time, manufacturers can receive orphan drug approval for repurposed drugs and for drugs that are sold to large numbers of people, which in turn fuels high prices for orphan drugs. Those prices strain pocketbooks in the developed world and leave patients in low- and middle-income countries with no way to access them. The costs of orphan drug laws may well outweigh their benefits; at a minimum, reform is needed.

In particular, terms of regulatory exclusivity should end when a drug is prescribed to a patient population exceeding the orphan-drug threshold—in other words, when the drug is no longer an orphan drug. EU law already allows a reduction of the exclusivity period to six years when a drug is deemed sufficiently profitable, but the authority has not been exercised. In addition, exclusivity should be available only where a manufacturer has developed a genuinely new compound, not when it has repurposed an old drug.

Manufacturers should also be required to pay back R&D subsidies once drug sales exceed any plausible estimate of development costs. In Japan, for example, manufacturers must repay R&D subsidies for drugs with annual sales that exceed 100 million yen (Wellman-Labadie 2010). The same approach should be adapted elsewhere.

It is crucial to recognize, however, that reforming orphan drug laws may not much reduce the prices of orphan drugs. Most would still be patented and the demand for the drugs would still remain high. To reduce prices, payers will have to consider the value of the drugs that they purchase. Where an orphan drug is not cost-effective—where yields only incremental health improvements at an enormous price tag—payers must be empowered to say “no.” Some governments have taken steps in that direction. Sweden, for example, has declined to pay for about half of newly approved orphan drugs (Garau 2009). If a critical mass of developed nations followed Sweden’s lead, drug manufacturers would come under considerable pressure to cut their prices.

@nicholas_bagley

Healthcare Triage News: A Study on Fish Oil Supplements!

I spend a lot of time knocking supplements for not having research behind them. It’s important therefore to highlight when such research is done.

If you want to read more, here’s the paper we’re covering: Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial

@aaronecarroll

The feds have been ordered to cough up risk corridor money.

A judge on the Court of Federal Claims has entered a $214 million judgment against the United States in favor of Moda Health, an Oregon insurer. Moda sued to recover money owed to it under the risk corridor program, a three-year program that was supposed to protect insurers from excessive losses on the exchanges. In emphatic language, the court ordered the government to pay up.

The Court finds that the ACA requires annual payments to insurers, and that Congress did not design the risk corridors program to be budget-neutral. The Government is therefore liable for Moda’s full risk corridors payments under the ACA. In the alternative, the Court finds that the ACA constituted an offer for a unilateral contract, and Moda accepted this offer by offering qualified health plans on the [exchanges]. …

Today, the Court directs the Government to fulfill [its] promise. After all, “to say to [Moda], ‘The joke is on you. You shouldn’t have trusted us,’ is hardly worthy of our great government.” Brandt v. Hickel, 427 F.2d 53, 57 (9th Cir. 1970).

This is exactly right. Even before the first risk corridor lawsuit was filed, I argued that insurers had viable claims against the federal government for any deficiencies. I’ve expanded on that view in an article in the New England Journal of Medicine and in extensive coverage on the blog. It was only a matter of time before a court entered a money judgment against the United States.

The stakes are enormous. Under the court’s reasoning, every insurer—not just Moda—can sue to recover its risk corridor money. Already, the government owes $8.3 billion for the first two years of the program. Total liability will certainly exceed $10 billion, and will probably be closer to $15 billion.

Will the government pay up? It’ll appeal to the Federal Circuit, but a pending case is likely to resolve the matter. In November, a different judge on the Court of Federal Claims dismissed a risk corridor lawsuit brought by Land of Lincoln. That decision is wrong, and it’s already been appealed. Land of Lincoln filed its opening brief at the end of January.

I expect the Federal Circuit to side with Land of Lincoln, probably sometime this summer or fall. However it rules, the appellate court’s decision will resolve the legal issue at the heart of all the risk corridor cases. Supreme Court review is then a possibility.

But the real wild card here isn’t the courts. It’s Congress. Without an appropriation, the federal government can’t make any payments from the U.S. Treasury, even to satisfy court judgments. As it stands, an indefinite, open-ended appropriation called the Judgment Fund exists to pay money judgment against the U.S. But Congress can amend the statute governing the Judgment Fund to prohibit any payments in connection with the risk corridor program.

Were Congress to sew up the Judgment Fund, the federal government couldn’t pay the judgments entered against it. The obligations would exist in the abstract, but no money would be available to satisfy them. And because the appropriations power has been vested exclusively in Congress, the courts can’t order Congress to appropriate money if it declines to do so.

The judge in Moda is right, though. Refusing to pay is a shabby way to treat insurers, which entered the exchanges in reliance on the federal government’s promises. Our president, however, has a track record of stiffing business partners. I wouldn’t be surprised if he signed a law doing just that.

@nicholas_bagley

How Would Republican Plans for Medicaid Block Grants Actually Work?

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

There are only so many ways to cut Medicaid spending.

You can reduce the number of people covered. You can reduce the benefit coverage. You can also pay less for those benefits and get doctors and hospitals to accept less in reimbursement. Or you can ask beneficiaries to pay more.

None of those are attractive options, which is why Medicaid reform is so hard. Medicaid already reimburses providers at lower rates than other insurance programs. How do you reduce the number of beneficiaries when the vast majority of people covered are poor children, poor pregnant women, the disabled, and poor older people? Which of those would you cut?

Reducing benefit coverage has always been difficult because most of the spending has been on the disabled and poor older people, who need a lot of care. Beneficiaries don’t have much disposable income, so asking them to pick up more of the bill is almost impossible.

That doesn’t mean that states haven’t tried. As I’ve discussed in past columns, a number are attempting to increase cost sharing. But this isn’t really a solution because it doesn’t change overall spending much at all.

Part of the challenge lies in the way Medicaid was set up in the first place. The federal government picks up between 50 percent and 100 percent (depending on the population and the per-person income) of whatever it costs to provide health care to a state’s population. Many, if not most, Republican plans would like to change that.

They are pushing for what many refer to as a block grant program. The federal government would give a set amount of money to each state for Medicaid; it would be up to the states to spend it however they like. These block grants could be set based on overall past state needs or based on the number of beneficiaries in the state, referred to as a “per capita” block grant. Some per-capita block grants function more like “ceilings” than outright grants, allowing the state to be paid at normal Medicaid rates, but with a maximum each state could get based on the per-capita calculation.

The supporters of such plans have a point. Medicaid has all kinds of complicated rules, which can create perverse incentives throughout the system. It’s possible that the needs of one state are different from another, and that with more leeway in how Medicaid is administered on a local level, states could improve how they manage health care for the poor. It’s also true that the needs of the beneficiaries are widely different (children and the disabled, for example), and that treating them under one large program is inefficient.

The fiscal magic behind a block-grants approach is that the federal government can then set how quickly the amount they’re responsible for will increase over time, regardless of how quickly medical spending grows. If a gap develops between how much a state needs to spend, and how much the block grant provides, it’s up to the state to make up the difference. Those who support such a plan argue it gives states greater flexibility to make their own Medicaid programs work better.

A recent New England Journal of Medicine article provides some perspective on how this might work by looking at what happened before Medicaid was created in 1965. Care for the poor in the 1950s was done through direct reimbursements to providers. It was calculated on a per-capita basis — the average cash and medical needs of those the programs covered. Those amounts were capped, based on age and demographics. This is quite similar to how many Republican proposals might function.

When these capped amounts weren’t enough to pay for the programs, states had to make cuts. They began to restrict who would be covered, what would be covered and how much care beneficiaries could use. Some states refused to cover children at all. Others didn’t cover doctors’ visits or drugs.

In the early 1960s, the programs had only 3.4 million beneficiaries nationwide.

The 1965 Medicaid law removed these caps, and today Medicaid covers about 81 million people, or about one in four Americans. By 1980, spending in the program had grown by a factor of 10, and many politicians began to panic about the cost. This rise appears to have come not as much from a rise in benefits or payments as a huge increase in enrollees.

Andrew Goodman-Bacon, an economist at Vanderbilt University and one of the authors of the article, told me: “From the time Medicaid began until 1980, the amount spent per Medicaid recipient went up about 68 percent. The number of enrollees, however, went up almost 700 percent. Moreover, since 1980, the amount spent per Medicaid beneficiary has been almost flat, at just under about $5,800.”

Given that the growth in Medicaid spending seems mostly because of increases in the number of people benefiting from the program, it seems logical that one of the few ways to cut spending is by reducing that number.

The fact that so much of the discussion about Medicaid block grants centers on cuts points to most policy makers’ assumptions that cuts will need to be made. According to the Center on Budget and Policy Priorities, the House Republican budget plan for fiscal year 2017 (if it had passed) would have led to a reduction in Medicaid spending by $1 trillion over a decade. By 2026, federal funding for Medicaid would be one-third less than under current law.

From states’ point of view, whether they are reimbursed by a block grant or a percentage of coverage doesn’t really matter as long as the amount is enough. Almost no block grant plan allows for this, though. Planned cuts are how block grants make future federal budget projections look so good.

There’s no magic in how Congress reduces spending under a block grant mechanism. It just says it will do so, and leaves the hard decisions to others. It’s possible that some states will come up with solutions we haven’t been able to see before, and find a way to reduce spending without causing problems. If they can’t, though, they will have to make do with less, make the hard choices and face the brunt of the blame.

@aaronecarroll

AcademyHealth: Population health can be improved with proper planning and honest assessments

It can sometimes feel like there’s nothing we can do to improve population health. That’s just not true. Go read more in my latest post over at the AcademyHealth blog!

@aaronecarroll

Get clear on what you think about the rule of law

The Trump campaign and the first weeks of the Trump presidency have raised concerns about his indifference to the norms of American government. Trump shows no concern for conflicts of interest and disregards norms of truth telling. Perhaps most troubling is his attitude towards the law. When a judge issued a hold on the President’s executive order on immigration, Trump tweeted:

The opinion of this so-called judge, which essentially takes law-enforcement away from our country, is ridiculous and will be overturned!

— Donald J. Trump (@realDonaldTrump) February 4, 2017

Many conservative and progressive critics have worried whether Trump understands the rule of law and accepts that his decisions may be subject to judicial review.

When it looks like the rule of law is in jeopardy, it’s easy to affirm your commitment to that principle. But this shouldn’t be easy. In this post, I want people to understand what commitment to the rule of law requires.

So what do we mean by ‘rule of law’? Jeremy Waldron writes that:

The most important demand of the Rule of Law is that people in positions of authority should exercise their power within a constraining framework of well-established public norms rather than in an arbitrary, ad hoc, or purely discretionary manner on the basis of their own preferences or ideology… the Rule of Law is not just about government. It requires also that citizens should respect and comply with legal norms, even when they disagree with them. When their interests conflict with others’ they should accept legal determinations of what their rights and duties are.

The rule of law seems foundational. The alternative is authoritarianism. But there are two questions you should ask yourself before you pledge an absolute commitment to the rule of law.

The first question is, am I willing to constrain myself to respect norms of legal process even when my party is in power?

Nicholas makes this point beautifully in Vox. First, he argues that whether Trump respects the rule of law could have profound implications for health care. Trump could, for example, decide not to enforce key provisions of the ACA. But Nicholas points out that President Obama also selectively enforced the ACA when that suited his policy interests.

At key points, President Barack Obama delayed aspects of the ACA in an effort to put health reform on a sound footing. The delays were classic examples of executive overreach; they never should have happened.

Nicholas said so on this blog at the time, making him one of the few consistent progressive defenders of the rule of law. This is the cost of commitment to the rule of law: you need to be ready to put your own goals in jeopardy.

Many people will look at the first question and reason that only a hypocrite and cynic would set aside her commitment to the rule of law when it was in her advantage to do so. But it’s not that easy. The second question about the rule of law is, am I willing to respect norms of legal process even at the expense of other substantive moral commitments I hold?

Try to imagine yourself in a situation where the government and its laws uphold a deeply unjust policy. Go reread Martin Luther King’s Letter from the Birmingham Jail. King wrote the letter to criticize moderates who opposed his tactics of non-violent resistance.

You express a great deal of anxiety over our willingness to break laws. This is certainly a legitimate concern. Since we so diligently urge people to obey the Supreme Court’s decision of 1954 outlawing segregation in the public schools, it is rather strange and paradoxical to find us consciously breaking laws. One may well ask, “How can you advocate breaking some laws and obeying others?” The answer is found in the fact that there are two types of laws: there are just laws, and there are unjust laws. I would agree with St. Augustine that “An unjust law is no law at all.”

King’s commitment to racial justice led him to select which laws he would respect and which he would not. For him, the hypocrites were those who would not make this choice.

I have almost reached the regrettable conclusion that the Negro’s great stumbling block in the stride toward freedom is not the… Ku Klux Klanner but the white moderate who is more devoted to order than to justice; who prefers a negative peace which is the absence of tension to a positive peace which is the presence of justice; who constantly says, “I agree with you in the goal you seek, but I can’t agree with your methods of direct action…”

Right now, you may not believe that you have to face a choice between devotion to order and devotion to justice. You may be confident that, for example, Trump will lose in court on his executive orders. This confidence is foolish. For at least the next two years, the Republicans can pass laws as they see fit. They will fill many open judgeships with conservative jurists. Trump will hire lawyers who are competent to draft his executive orders. Like King, you may have to choose between what judges say the law is and what you think is just.

Get clear now on what you think about the rule of law. You may have substantive views about justice that are more important to you than your commitment to “well-established norms” of legal process. If so, you are not an absolutist for the rule of law. Your commitment is limited and you should clarify those limits: here is where I follow the law, and here is where I go to jail.

@Bill_Gardner

This is how you study supplements. Then you accept the results.

I spend a lot of time knocking supplements for not having research behind them. It’s important therefore to highlight when such research is done. From JAMA Internal Medicine, “Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial“:

Importance: Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure.

Objective: To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure.

Design, Setting, and Participants: The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation.

Interventions: Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks.

Main Outcomes and Measures: The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome.

People who require hemodialysis need to have their blood cycles regularly. This often requires a permanent means for vascular access. Unfortunately, such access carries with it the risk of morbidity and mortality.

There are a number of ways to achieve permanent vascular access. In general, arteriovenous fistulae are preferred to synthetic arteriovenous grafts or central venous catheters. AVFs take longer to mature before use and have a much greater risk of early failure.

Some have theorized that omega-3 fatty acids (fish oil) can help “not only inhibiting platelet aggregation1 but also decreasing blood viscosity, improving red blood cell flexibility, promoting vasodilation, inhibiting smooth muscle cell proliferation, and reducing inflammation.” Others theorize that aspirin might do similar things.

This trial wanted to see if either of these things were true. Researchers ran a double-blinded, randomized controlled trial of participants with stage 4 or 5 kidney disease at 35 dialysis centers in Australia, Malaysia, New Zealand, and the UK. Participants were randomized to get fish oil, placebo, both, or neither. Those that could not take aspirin or who couldn’t take aspirin were excluded from the randomization for aspirin, of course. The primary outcome of interest was failure of their fistula or a failure to use the fistula.

This wasn’t a small study. Of the 1415 deemed eligible over the study period, 567 were randomized and included in the trial. Of these, 406 were randomized to get aspirin or placebo as well.

Let’s talk about fish oil first. The failure rate in both arms (intervention and placebo) was 47%. No difference at all. Fish oil didn’t reduce fistula thrombosis or cannulation failures either.

Aspirin didn’t work either. The rate of failure was 45% in the aspirin arm and 43% in the placebo arm.

I grant you that this is a pretty focused trial, for a pretty specific cause. But we should respect the process and acknowledge the efforts. Fish oil and aspirin don’t seem to percent failures of arteriovenous fistulas in the year after surgery. Own it. Consider changing your practice.

 

@aaronecarroll