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Did a high-profile program really slash hospital spending? Or was it a cautionary tale of ‘regression to the mean’?
In the late 19th century, English polymath Sir Francis Galton noted that tall parents often had kids shorter than they were, while short parents often ended up with taller kids. He dubbed this regression to the mean — when something measured as extreme in a first instance is likely to be measured as less extreme later on.
That concept has important implications for health care policy today, one of which is that more health policymakers and health care researchers should use randomized evaluations to avoid problems of regression to the mean in estimating the effects of policies.
In the U.S. health care system, the very highest-cost patients — known as super-utilizers — have been a focus of attention. That is because this 1% of patients account for almost 25% of all U.S. health care spending. A spate of high-profile studies have reported dramatic reductions in health care spending from programs designed to keep super-utilizers out of the hospital through various means, such as coordinating their outpatient care and coaching them on managing their conditions and medications.
This work raises an important question: Does hospital use decline because of the programs or, due to regression to the mean, because high-use patients are likely to use care less in the future?
Several colleagues and I set out to answer that question in partnership with the Camden Coalition of Healthcare Providers. It had created a comprehensive health care delivery model that aims to meet the medical and social services needs of very high-use patients who have had at least two hospital admissions in the last six months and two or more chronic conditions, among other criteria. The coalition has been widely heralded as a promising approach for reducing costs and improving health. Dr. Atul Gawande profiled the program in the New Yorker and the coalition’s founder won a MacArthur “genius grant.”
As a data-driven, learning organization, the coalition did not want to rest on its considerable laurels. To learn what its program was doing — and innovate based on the findings — it partnered with our research team to conduct a randomized controlled trial (RCT).
We randomly assigned patients who were eligible and who consented to participate to receive either the coalition’s program or status quo care. Randomization ensured that, at the start of the program, these two groups were similar. That way, the outcomes observed in the control group would tell us what would have happened over time in the intervention group in the absence of the program.
When we looked at patients in the intervention group, the results of the Camden Coalition’s program looked very encouraging: Participants in this group visited the hospital about 40% less in the six months after the intervention. But as we report in this week’s New England Journal of Medicine, we saw the same decline in hospital use among those in the control group. These results tell us that the improvements we saw in the intervention group were the result of regression to the mean, not the coalition’s program.
These results offer an important lesson: We wouldn’t have accurately measured the intervention’s impact if we hadn’t done a randomized controlled trial.
Since we learn more from RCTs than just the impact of an intervention on a single outcome, finding no effect doesn’t mean the end of the road. In the Camden Coalition trial, our results suggest that existing systems poorly serve the complex needs of the coalition’s patients. The Camden group (and others) are now exploring models involving more complete designs for providing care.
Regression to the mean isn’t unique to health care, but it is a particularly salient concern for studies of health care programs that are often (and understandably) implemented in response to extreme signals like advanced disease, high expenditures, or excessive prescribing. Fortunately, when randomized controlled trials are feasible and ethical, they provide a way to determine the effect of a program free from concerns about regression to the mean and other biases.
Concern about excessive prescribing presents another example where regression to the mean may lead to spurious findings but where an RCT can provide clear results. The Centers for Medicare and Medicaid Services recently partnered with researchers to conduct randomized evaluations of interventions designed to curb overprescribing of Seroquel, an antipsychotic drug. The researchers found that sending strongly worded letters that compared high prescribers’ behavior to their peers’ reduced overprescribing by 11%.
We can be confident that the letters are what caused the reduction in prescribing — rather than just regression to the mean (today’s extreme prescribers are less likely to be as extreme tomorrow) — because the trial included as a randomized control group prescribers who only received standard CMS outreach.
That study also shows how we can build on and learn from any finding, whether it is positive, negative, or null. The CMS overprescribing study built on a prior randomized controlled trial which found that the original peer comparison letters CMS had been regularly sending did not reduce prescribing of controlled substances. As a result, the researchers and CMS used psychological and other research to innovate and devise a different kind of letter to be sent to a different set of providers, which then did reduce prescribing behavior.
Randomized controlled trials can be used to study programs and policies across the health care industry. In my experience leading J-PAL North America’s U.S. Health Care Delivery Initiative, which funds and conducts randomized controlled trials of health care delivery interventions, RCTs have shed light on issues such as the effectiveness of clinical decision support alerts on ordering inappropriate medical imaging and nudges to improve consumers’ choices of health insurance. And there are ongoing RCTs of many more interventions, including food as medicine, home visits by nurses, and opioid buyback programs.
J-PAL North America is part of a growing movement of health systems, payers, providers, and more that are using randomized controlled trials to test and learn, whether through evaluations of whole programs or quick process improvements. Researchers at NYU Langone Health use rapid-cycle, randomized tests aimed at quickly evaluating simple process improvements to encourage best practices. This one medical center launched 10 trials in the first year alone and hopes to launch dozens more.
Finding solutions to address the complex medical and social needs of patients is a pressing issue. Yet all too often we don’t rigorously evaluate these solutions, which hurts patients we could be helping. Randomized clinical trials are essential tools for helping us learn, adapt, and move forward on innovative solutions that make peoples’ lives better.
Kansas has reached a deal to expand Medicaid, covering 150,000 people
https://www.vox.com/policy-and-politics/2020/1/9/21058531/kansas-medicaid-expansion-obamacare-trump
It looks like Kansas will become the 37th state to expand Medicaid through the Affordable Care Act, the latest breakthrough in more conservative territory for the health care law.
Democratic Gov. Laura Kelly, a moderate elected in 2018 in the anti-Trump wave driven largely by health care, and Sen. Jim Denning, the Republican leader of the state Senate announced Thursday that they had reached a deal on Medicaid expansion.
Under Obamacare, states can expand coverage to anybody with an income 138 percent of the federal poverty level or less (about $17,000 for an individual or $29,000 for a family of three) and receive a generous federal funding match.
Between 130,000 and 150,000 people are expected to be covered by Medicaid expansion in Kansas, mostly adults without children or parents currently ineligible for benefits despite living in or near poverty. Roughly 9 percent of Kansans are uninsured.
According to the AP, the agreement between Kelly and Denning includes a provision for state support to reduce private insurance premiums, to prevent people eligible for Medicaid expansion from leaving their current private plan (if they have one) to join the public program:
Denning had proposed financing his new program by increasing tobacco taxes, including a $1-per-pack increase in the state’s cigarette tax, to $2.29. His compromise with Kelly gives the state a year to develop the premium-reduction program and drops the tax increase, which Kelly and many lawmakers thought wasn’t likely to pass anyway.
It’s a relatively small concession for Republican support. An estimated 50,000 people would be expected to make the switch. The compromise notably does not include work requirements, which some other GOP-led states have sought (though they are on hold in the courts) as a condition of expansion. There will also be small premiums (about $25 a month), a provision approved in other Republican-leaning states looking to expand.
In some ways, Medicaid expansion has proven the most important part of Obamacare, covering 20 million or so people, but it has yet to reach its full potential. That’s because the Supreme Court ruled in 2012 that states must have the option to refuse to expand the program, and many Republican-led states have. About 2.5 million people, half of them in Texas and Florida, don’t have health coverage because their state has blocked Medicaid expansion.
But the number of non-expanding states has shrunk over the years, with a number of Republican states unable to refuse the ACA’s deal of more federal funding and more people with insurance. Even Vice President Mike Pence had cut a deal as governor with President Obama to expand Medicaid in Indiana. Voters in Idaho, Nebraska, and Utah have approved Medicaid expansion at the ballot box in the last few years.
Now Kansas looks like it will join the expansion ranks. Previous attempts to expand Medicaid ran up against the veto pen of a GOP governor. But Kelly’s election changed the situation.
Its decision is also a small act of defiance: Even as 20 red states and the Trump administration fight to overturn Obamacare in the courts, government leaders in Kansas are pushing to expand the law’s reach in their state to cover more people. Though the ideological battle over the law isn’t totally over, in practice, its reach is only growing.
New York State Investigates Christian Health Cost-Sharing Affiliate
Subpoenas have been issued to a company that solicits memberships for a health insurance alternative that offers no guarantees for covering medical bills.
New York State officials are investigating a business representing a major Christian group offering an alternative to health insurance, joining several states scrutinizing these cost-sharing programs that provide limited coverage.
On Wednesday, New York state insurance regulators issued a subpoena to Aliera, which markets the Christian ministry run by Trinity Healthshare, according to people who have seen the subpoena.
More than one million Americans have joined such groups, attracted by prices that are far lower than the cost of traditional insurance policies that must meet strict requirements established by the Affordable Care Act, like guaranteed coverage for pre-existing conditions.
These Christian nonprofit groups offer low rates because they are not classified as insurance and are under no legal obligation to pay medical claims. But state regulators are questioning some of the ministries’ aggressive marketing tactics, saying some consumers were misled or did not grasp the lack of comprehensive coverage in the case of a catastrophic illness.
Some members have paid hundreds of dollars a month, and then have been left with hundreds of thousands in unpaid medical bills in several states where the ministries, which are not subject to regulation as insurers, failed to follow through on pooling members’ expenses.
Numerous states are taking action against Aliera Healthcare, the for-profit company based in Georgia that was been the subject of an investigation by The Houston Chronicle. The Texas attorney general sued Aliera last summer to stop it from offering “unregulated insurance products to the public,” while Connecticut, Washington and New Hampshire are trying to stop Trinity and Aliera from doing business in those states.
Regulators say they are concerned that the ministry is, in fact, operating as an insurer. In New York, which has not previously investigated any ministries, there have been 15 to 20 complaints, including accusations that Aliera misrepresented the coverage being offered. It’s not clear how many customers Aliera has in New York.
“It’s deeply disappointing to see state regulators working to deny their residents access to more affordable alternatives offered by health care sharing ministries,” said Aliera in an emailed statement.
“We’re proud of the work we do to help ministries provide a more flexible method for securing affordable high-quality health care, and we will continue to vigorously defend against the false claims about our company, just as we expect the health care sharing ministries we serve to vigorously defend their members’ right to exercise their religious convictions in making health care choices,” it said.
Trinity, which was not subject to the subpoena, has said its website makes clear that the ministry does not offer health insurance.
The most expensive health care option of all? Do nothing.
‘Medicare for all’ debate sidesteps cost of current system.
The projected multitrillion-dollar cost of “Medicare for All” has pitted Democratic presidential candidates against each other as they argue about the feasibility of single-payer health care.
But the reality is the current health system may cost trillions more in the long run and be less effective in saving lives.
Spending on Medicare, Medicaid, private health insurance and out-of-pocket expenses is projected to hit $6 trillion a year — and $52 trillion over the next decade. At the same time, the number of people with insurance is dropping and Americans are dying younger.
Sen. Bernie Sanders and other single-payer advocates say Medicare for All would cost the government far less — between $20 trillion and $36 trillion over a decade — by slashing overhead, eliminating out-of-pocket costs and empowering federal officials to bargain directly with hospitals and drugmakers. But the streamlined system would have to care for millions of currently uninsured people at a significant cost to taxpayers, and experts disagree whether it would actually save money in the long run.
Centrist Democrats are pushing narrower plans that would, among other things, expand tax credits for people just above the Obamacare subsidy threshold. Virtually no one is arguing for maintaining the status quo, but that’s precisely what could happen given that congressional gridlock has stymied even popular, and bipartisan, causes like halting surprise medical bills.
“It’s really hard to see anything breaking through, especially when the industry interests and the money they’re willing to spend on lobbying and campaign contributions is just mind-boggling,” said Sabrina Corlette, a researcher at Georgetown University’s Center on Health Insurance Reforms. “And, without question, we are on an unsustainable trajectory.”
With Medicare for All and its price tag likely to come up in the next Democratic debate Jan. 14 in Iowa, here are five of the costliest consequences of inaction:
National health spending keeps rising
The Centers for Medicare and Medicaid Services estimates that nationwide health spending will hit $6 trillion a year by 2027 absent any changes in law. That would be nearly a fifth of the economy. In total, the United States is slated to spend about $52 trillion over the coming decade.
The cost drivers include hospitals, physician and clinical services and prescription drugs. Some local health systems have become monopolies that can largely set prices as they please — leading to higher premiums and more out-of-pocket spending for consumers.
“Even the biggest insurance plans are not big enough to bargain down the cost of services, and they don’t have an incentive to,” said Wendell Potter, a former Cigna executive-turned whistleblower and single-payer advocate.
An aging population is driving up Medicare spending, but the rising cost of private insurance is the biggest factor. A recent Kaiser Family Foundation analysis found per capita spending for private insurance grew by nearly 53 percent over the last decade, or more than double the hike in per capita Medicare spending.
More people will be uninsured
The Census Bureau reported in September that the number of Americans without insurance grew by 2 million people since 2017 — the first increase in nearly a decade. Even with a healthy economy and low unemployment, more than 27 million people weren’t covered at any point last year. That could grow to 35 million by 2029, per the Congressional Budget Office, under current law.
The number of people enrolling in the Obamacare marketplace has declined, and more people are dropping employer-sponsored insurance due to cost and other concerns.
Part of this is President Donald Trump’s doing — the administration has slashed efforts to push Obamacare enrollment and rolled back the massive marketing effort that the Obama administration rolled out for years.
There are also more than 400,000 additional uninsured children than just two years ago — and 4 million in all — and states that haven’t expanded Medicaid are seeing the biggest spikes.
“What we also miss in the debate is the number of people temporarily uninsured, who miss open enrollment, who are between jobs, who fall through the cracks,” said Adam Gaffney, a Harvard Medical School researcher and the president of Physicians for a National Health Program. “I see people all the time in my practice in that situation who don’t fill prescriptions and experience serious complications.”
Going without insurance hits patients and health care providers: Average hospital spending on care for the uninsured was $13 million in 2018 up roughly 3 percent annually since 2016.
Coverage will be skimpier
As the cost of health care has skyrocketed, insurance companies have squeezed patients, charging higher premiums, deductibles and co-pays, and creating narrow networks of providers and aggressively billing for out-of-network care.
Since 2009, the amount workers have had to pay for health insurance has increased 71 percent, while wages have only risen 26 percent over that time.
More than 80 percent of workers now have to pay a minimum amount out of pocket before insurance kicks in — and the amount of that deductible has doubled over the last 10 years, now standing at an average of $1,655, though many workers have to pay a lot more.
These costs are putting care out of reach for millions.
A new Gallup poll found that a full quarter of adults have put off treatment for a serious medical condition due to the cost — the highest since Gallup began asking the question three decades ago. A full third say they’ve delayed or deferred some kind of health care service over the past year. Another Gallup and West Help survey found that 34 million people know at least one friend or family member who died over the past five years after skipping treatment due to costs.
Needed drugs will become more out of reach
U.S. patients pay vastly more for prescription drugs than people in other developed countries and the disparity is set to grow. The United States spent $1,443 per person on prescription drugs in 2018, while other developed countries fell somewhere between $466 and $939.
In just five years, national spending on prescription drugs increased 25 percent, according to the Government Accountability Office, and CMS expects that increase to “accelerate” over the next several years.
Increasingly, patients are responding by forgoing their medications. Gallup found in November that nearly 23 percent of adults — roughly 58 million people — said they haven’t been able to “pay for needed medicine or drugs that a doctor prescribed” over the past year.
This widespread inability to take needed medication, a government-funded study found last year, is responsible for as much as 10 percent of hospital admissions. And the Centers for Disease Control and Prevention estimates that medication nonadherence accounts for somewhere between $100 and $300 billion in national health spending every year.
Americans will continue to get sicker and die younger
The cost of maintaining the status quo is evident not only in dollars but in human lives.
Life expectancy in the United States has declined over the last three years, even as other developed countries around the world saw improvements.
Though the United States spends nearly twice as much on health care as other high-income countries, there’s been a stark increase in mortality between the ages of 19 and 64, with drug overdoses, alcohol abuse, suicide and organ diseases driving the trend. It’s cut across race and gender with the worst effects felt in rural areas.
The opioid epidemic only accounts for a fraction of the problem. The National Research Council found that the United States has higher mortality rates from most major causes of death than 16 other high-income countries.
Researchers at USC estimate that if these trends continue, it would take the United States more than a century to reach the average life expectancy levels other countries hit in 2016.
Cartoon – Finished the Project Plan
HENRY KOTULA 