Why Cochrane is Wrong About Hypertension. Very Wrong.

By SWAPNIL HIREMATH MD

Archie Cochrane and the Cochrane Collaboration

Archie Cochrane was born in Scotland, educated in London (King’s College, University College and London School of Hygiene and Tropical Medicine) and worked in Cardiff, Wales. His work as a doctor during the Spanish Civil War and World War II, especially in a prisoner of war camp in Salonica, is credited with his push towards generating higher quality evidence. In his description of the clinical trial he conducted, he mentions James Lind as his hero. Ironically, that clinical trial – with weak randomization, open allocation, non-blinding of investigator or participants, and use of surrogate outcomes, would rate poorly in the Cochrane risk of bias tool.

But the scientific method of measuring stuck with him, and among many other achievements, he did perform a proper randomized clinical trial (RCT) a few decades later. He continued to be strong supporter of RCTs, and pushed for the Medical Research Council (MRC) to move from purely fundamental research towards applied clinical research. As an aside, the first proper RCT in the modern era was funded by the MRC, and was published in 1950 – on the use of Streptomycin vs para-amino salicylic acid, or a combination, in tuberculosis. Far more influential was his paper (and later book) published as part of the Rock Carling Fellowship, available here freely and worth a read. It’s where he puts forward the vision for RCTs in moving towards what he termed an ‘effective, efficient health service’.

The Cochrane Collaboration was established Cochrane’s death, started off as a database of clinical trials put together by Iain Chalmers, and later included systematic reviews. Now there are about 50 Cochrane review groups, all over the world.  Even the Cochrane logo is a forest plot (though after reading this, I dare not show it – but you can easily go and see it for yourself) from a 1990 systematic review (SR). This original systematic review is one of 12 RCTs, reporting a significant benefit in lowering respiratory distress syndrome from use of antenatal steroids before preterm delivery. It is a classic example of how pooling underpowered studies can provide a powerful summary estimate. You can read more about the history of the Cochrane collaboration in this perspective from 3 decades ago, if you can open the pay wall gates which, needless to say, is somewhat strange for a publicly funded organization. There is no monopoly on performing SRs, and they have proliferated widely since. However, Cochrane SRs are held in higher esteem. They are considered the gospel truth – in some cases, undeservedly, such as their review of hypertension.

Cochrane Hypertension Review

An example of a Cochrane SR which lost its way is this one, purportedly showing that intensive blood pressure (BP) lowering in patients with cardiovascular (CV) disease has no benefit. Interestingly, it is an update of another SR, done a few months earlier by the same authors – which the interested reader can check out for how much the data changed in 8 months to deserve a different analysis. The results of this SR, published in July 2018, are potentially practice changing. Hypertension Canada guidelines say that patients with established CV disease should be targeted for intensive BP lowering (systolic BP target < 120). The 2017 American Heart Association/American College of Cardiology (ACC/AHA) recommend a target of < 130/80 in these patients. Even the European society of Cardiology/Hypertension in the recently announced 2018 update recommend systolic BP < 130. Is everyone wrong except Cochrane?

It is instructive to examine why the guidelines differ from the Cochrane SR. The systematic component of an SR refers to objective criteria for studies that should be included. This SR included RCTs with a sample size greater than 50, and more than 6 month follow up, which are quite reasonable and commonly used criteria. The outcomes reported had to include mortality and/or cardiovascular events, not just change in blood pressure, which is again a reasonable decision if the focus is on hard outcomes. The population of patients included, however, were those with established CV disease: ie history of myocardial infarction, stroke, chronic peripheral vascular occlusive disease, or angina pectoris. An intermediate or high cardiovascular risk was not sufficient (which was a criteria for many recent RCTs such as SPRINT, ACCORD and HOPE-3). So if a trial included a mix of these patients, then only the subgroup data of those with established CV disease as set out above would be used. See table 1 for how many patients from the individual trials made it to the SR.

Table 1: Sample Size of included trials, and the proportion included in Cochrane SR. Note that HOT and SPS3 contributed more than 50% weight overall

This matters because one if throwing away information when one is doing this – so you need a really good rationale for it. Since the sample size determines how much ‘weight’ a particular trial adds to the meta-analysis, this results in HOT (30%) and SPS3 (25%) being the heavyweights in Cochrane’s SR. Overall, both these RCTs reported no benefit in BP lowering – so the results of the Cochrane SR are not particularly surprising once this is taken into account. Was this a wise decision though?

Additionally, if you consider patients with high CV risk, and those with subclinical CV disease, not worthy of inclusion, consider the actual inclusion criteria of these trials and whether one thinks this is a clinical homogenous set (table 2).

Table 2: Summary of patient population included in the trials

More importantly, this is a comparison of two groups: lower and higher BP target. Over time, BP thresholds (and yes, this is all dichotomania) have decreased. In the 19th century the discussion was about whether BP should be treated at all or whether it was a homeostatic mechanism. The 1964 Veterans Affairs trial changed that – though it was diastolic BP targets at that time (given that diastolic hypertension is more common in the young to middle aged population studied then). In recent times the discussion has moved towards systolic BP. Specifically in the elderly, the HYVET trial results suggested systolic BP lowering in the very elderly to < 150 mm Hg is beneficial. In the non-elderly, <140 mm Hg has been accepted for a while, since JNC 7, and even the controversial JNC 2014 recommendation was < 140 mm Hg. Hence in the last decade or two, the push has been towards even lower, ie whether < 130 mm Hg or < 120 mm Hg can provide even more benefits. The trials in this area have been careful about choice of patient subpopulations and interventions in this push.

So one would expect this Cochrane SR would choose < 120 versus < 140? Or perhaps < 130 versus < 140? Umm, no it didn’t. The two groups were:

  • lower blood pressure treatment target:
    • systolic/diastolic ≤ 135/85 mmHg;
    • mean blood pressure ≤ 102 mmHg.
  • standard blood pressure treatment target:
    • systolic/diastolic ≤ 140 to 160/90 to 100 mmHg;
    • mean blood pressure ≤ 107 to 120 mmHg.

To belabour this point, the authors of the Cochrane SR are happy to compare RCTs that used systolic/diastolic or mean BP targets. Diastolic and mean BP targets are not used in recent RCTs, these criteria help certain older RCTs make it in. Also, their range is very narrow: systolic BP < 135 vs systolic BP < 140. Diastolic BP < 85 vs diastolic BP < 90. See table 3 below for the intervention and control arms of RCTs that got included to fulfil those eligibility criteria.

Table 3: Low and Standard BP targets as planned in the original trials

 More importantly, not all these RCTs actually managed to lower the BP as desired – which is not totally surprising, but is somewhat important when one considers the outcome in some RCTs versus others. Note in particular the differences (or lack thereof) in achieved BP in the heavyweight HOT trial in table 4.

Table 4: Achieved systolic blood pressure in the included trials. Note that achieved SBP in the HOT trial in intervention group was higher than achieved SBP in the control arm in ACCORD and SPRINT

 So let’s recap: the Cochrane SR considers that is perfectly fine to lump an RCT from 1998, which targeted a diastolic BP < 85 and did not achieve a meaningful difference between groups, with a 2016 RCT which aimed for a systolic BP < 120, and did achieve a significant difference? Reminded of apples and oranges anyone?

The “no difference” result actually only applies to total mortality. When it comes to CV events, there is a significant lowering, but it is curiously stated as ‘the total  number  of  cardiovascular  events  was  not  significantly  reduced  in  the  lower  blood  pressure  target  group  compared  with  the  standard  group  (RR  0.89,  95%  CI  0.80  to  1.00;  P=  0.044;  six  studies)’. Quite a head-scratcher. There is a 11% relative risk reduction in CV events, with a p value < 0.05, which the authors state as being ‘not significantly reduced’. Perhaps the authors have chosen a different p value threshold compared to Ronald Fisher’s beloved 0.05?

Why should any of this matter? Consider the implications of this Cochrane SR: they are not saying that individuals with low risk receive little benefit from intensive BP lowering (a previous Cochrane SR does say that). They are saying that individuals with highest risk, those with established CV disease, receive little benefit from intensive BP lowering. Not only does this have little biological plausibility, we see above that it is a methodologically unsound result. The SPRINT trial included individuals at higher CV risk (including those with established CV disease) and demonstrated a mortality benefit. The need to do a trial like SPRINT was precisely because previous RCTs like AASK or HOT were not designed to answer that question. The interventions were different and the treatment thresholds were different. ACCORD and SPS3 were planned during the same time – and with overlapping investigators, and deliberately chose eligibility criteria to answer questions in populations which are different: diabetes with ACCORD, and recent lacunar stroke with SPS3. Hence to take subgroups from all these wildly different RCTs and combine them into a meta-analysis is like using elephant’s foreskin for plastic surgery – ok, I’m exaggerating, but Cochrane is really getting under my nerves.

A common criticism of SRs, especially of the quantitative part (i.e. meta-analysis) is “garbage in – garbage out”. One is sometimes combining apples and oranges to make a smoothie instead of a fruit salad. Is there a better way out when one does want to pool many different trials and synthesize the evidence? The Cochrane SR discussed so far uses study-level summary data from each trial. One could do a individual patient level meta-analysis which has far more granular data. And the BP Trialists Collaboration has done just that. Even pre-dating SPRINT, in 2014, on the basis of individual patient data from 11 trials and 67,475 patients, they demonstrated the benefit of BP lowering in patients with differing level of Cv risk. They reported that the relative risk reduction remains constant at different levels of CV risk, but the absolute risk lowering is greater in individuals at higher baseline CV risk.  But we don’t even need individual patient-level meta-analysis. A more sensible SR, published in 2016 in the Lancet with study level data, also reports significant benefit with intensive BP lowering – in patients with and without underlying CV disease. See a figure from that SR below:

Figure 5 from Ettehad et al, Lancet, 2016, reporting a benefit with BP lowering even in those with pre-existing CV disease

Should an systematic review always be on the top of the evidence pyramid? And is the Cochrane SR the last word? Hopefully I have convinced you that Cochrane’s reviews aren’t as infallible as many believe.

There are subjective and qualitative decisions made when performing an SR, and one has to appraise them critically. SRs are reasonable when there are only a few small RCTs. Once a large randomized trial has been done, put more faith in the RCT – and when large RCTs are published with seemingly different results, try understanding the trials individually rather than putting them into a grinder. Sometimes studying the individual trees matter more than a bird’s eye view of the forest.

I admire Archie Cochrane. I’m disappointed by the organization named after him.

Individual RCTs included in the Cochrane Review

HOT https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(98)04311-6/abstract

AASK https://jamanetwork.com/journals/jama/fullarticle/195530

ACCORD https://www.nejm.org/doi/full/10.1056/NEJMoa1001286

SPRINT https://www.nejm.org/doi/full/10.1056/NEJMoa1511939?query=featured_home#t=articleTop
SPS3 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60852-1/abstract

PAST BP https://www.bmj.com/content/352/bmj.i708

About the Author

Swapnil Hiremath is a nephrologist from Ottawa and co-creator of #NephJC. He pretends to diss systematic reviews despite having authored many.

He is a member of the Hypertension Canada guidelines task force, which suggest intensive BP lowering in patients with CV Disease. The opinions expressed here are personal and do not represent HT Canada

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Prior Authorizations: Will They Become Damocles Sword?

By NIRAN AL-AGBA

Niran Al-Agba, MD, FAAP

In July 2009, the family of Massachusetts teenager Yarushka Rivera went to their local Walgreens to pick up Topomax, an anti-seizure drug that had been keeping her epilepsy in check for years. Rivera had insurance coverage through MassHealth, the state’s Medicaid insurance program for low-income children, and never ran into obstacles obtaining this life-saving medication. But in July of 2009, she turned 19, and when, shortly after her birthday, her family went to pick up the medicine, the pharmacist told them they’d either have to shell out $399.99 to purchase Topomax out-of-pocket or obtain a so-called “prior authorization” in order to have the prescription filled.

Prior authorizations, or PAs as they are often referred to, are bureaucratic hoops that insurance companies require doctors to jump through before pharmacists can fulfill prescriptions for certain drugs. Basically, they boil down to yet another risky cost-cutting measure created by insurance companies, in keeping with their tried-and-true penny-pinching logic: The more hurdles the insurance companies places between patients and their care, the more people who will give up along the way, and the better the insurers’ bottom line.

PAs have been a fixture of our health care system for a while, but the number of drugs that require one seems to be escalating exponentially. Insurance companies claim that PAs are fast and easy. They say pharmacists can electronically forward physicians the necessary paperwork with the click of a mouse, and that doctors shouldn’t need more than 10 minutes to complete the approval process.

But in my experience, that’s rarely the case. In order to get my patients the drugs they need, I regularly spend more than half an hour on the phone with ill-trained customer service reps who don’t know the first thing about pharmaceuticals and whose job description consists of being as obstructionist as possible.

And I’m not alone. A video by an independent physician with a sense of humor documented his Kafka-esque bid to obtain a PA for a patient. The video lasts 21 agonizing minutes. And studies have shown that PAs gobble up at least 20 hours per week in the average physician’s office. Even in an age when many aspects of practicing medicine in the United State have become nightmarish, PAs hold a place of particular sinister distinction.

Now, back to the Rivera case in Massachusetts. After Walgreens declined to fill Yarushka’s Topomax prescription, her family returned to the pharmacy four more times –each time without success. (It’s unclear whether or not Walgreens ever actually sent an authorization request to the physician’s office.)

Without the drug she’d relied on for years, Yarushka had three seizures. The last one proved fatal.

Her grief-stricken family subsequently filed a wrongful death suit –not, as might be expected, against the insurance company that required the PA in the first place, but rather against Walgreens, Yarushka’s physician and his practice.

To my mind, this case gets it all wrong, and in so doing, potentially dangles Damocles’ sword over the heads of each and every physician and pharmacist practicing in the United States today. The fact is that both Yarushka’s doctor and the Walgreens pharmacist did their jobs: Her physician issued a prescription for the life-saving anti-seizure drug, and the pharmacist tried to dispense the medication. It was Yarushka’s insurance company –not the physician or the pharmacist- that was the monkey wrench, arbitrarily denying coverage for her medication without any reasonable justification.

Medical malpractice is defined as negligence by act or omission in cases where the prescribed treatment fell below the accepted standard of practice and caused injury or death. In the Rivera case, MassHealth alone created the barrier between Ms. Yarushka and her life-sustaining medication.  The insurance company was, effectively, practicing medicine without a license. And it alone should be held accountable for the tragically predictable outcome after overriding the sound judgment of her physician and pharmacist.

But because of a legal doctrine called sovereign immunity, which shields states from civil or criminal prosecution, it’s highly unlikely that MassHealth, a state-run insurer, will ever face legal consequences Yarushka’s –or any other, for that matter.  How many more patients have to die before we force insurers to prioritize patients over profit?

The Rivera case is still winding its way through the court system in Massachusetts, but a verdict against Walgreens will open a Pandora’s box for medical professionals across the country, effectively holding them legally liable for the decisions and practices of an all-powerful third party that’s under no obligation to follow their medical recommendations.  If MassHealth is not held accountable for causing the wrongful death of Yarushka Rivera, then more insurers will be emboldened to practice medicine without a license, which will surely lead to the deaths of countless other patients nationwide.

Niran is a third-generation primary care physician in solo practice in an underserved area in Washington State.  She blogs at peds-mommydoc.blogspot.com and pens a bimonthly column in the Kitsap Sun. She can be contacted at @silverdalepeds on Twitter.

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Comprehensiveness is Killing Primary Care

By HANS DUVEFELT

Dr. Hans Duvefelt

In most other human activities there are two speeds, fast and slow. Usually, one dominates. Think firefighting versus bridge design. Healthcare spans from one extreme to the other. Think Code Blue versus diabetes care.

Primary Care was once a place where you treated things like earaches and unexplained weight loss in appointments of different length with documentation of different complexity. By doing both in the same clinic over the lifespan of patients, an aggregate picture of each patient was created and curated.

A patient with an earache used to be in and out in less than five minutes. That doesn’t happen anymore. Not that doctors and clinics wouldn’t love to work that way, but we are severely penalized for providing quick access and focused care for our well-established patients.

Why is that?

Our Quality mandates have ended up creating perverse roadblocks and disincentives for taking care of the simplest needs of our patients. Any time we don’t screen for depression, alcohol use, smoking and readiness to quit, obesity, immunization status, blood pressure control and so on, we lose brownie points and, increasingly, money.

This is happening near me:

The primary care practices of Maine Coast Memorial Hospital in Ellsworth Maine have lost many, if not most, of their providers in recent years after some belt-tightening due to running the clinics at a loss. They are not able to see new patients for six months or more. BUT the hospital is actively promoting its walk-in urgent care center – and they don’t seem to have trouble staffing it, and don’t appear to be losing very much money on it.

Bangor, Maine, home of a small Catholic Hospital and a 400+ bed hospital with a level 2 trauma designation, cardiac surgery, neurosurgery and many other specialties, has a severe lack of primary care doctors in spite of having a Family Medicine residency. Yet, a private out-of-state company is building a brand new freestanding urgent care center a couple of blocks from the Catholic hospital.

Quick and easy acute care visits could generate revenue with positive cash flow for primary care practices, especially for Federally Qualified Health Centers with their flat rate reimbursement, but possibly for all practices, if CMS’ new proposal to scrap differentiated Evaluation and Management codes becomes reality. But the requirement to weigh down the simplest visits with all those screening requirements eliminates the incentive to nimbly meet patients’ need for access.

The end result will be that primary care providers will become chronic care providers only, and care will be fragmented so that anything profitable will be siphoned off to freestanding entrepreneurs or hospital-owned profit centers. Meanwhile, primary care practices risk becoming more and more of a millstone around their hospital owners neck because all their patient visits are more complex and costly than the reimbursement scheme can support.

And more and more providers will be tempted to jump ship for the easier work and greater predictability of a Doc in a Box career.

The only solution is to acknowledge that Family Medicine and all primary care is meant to assess patients over the continuum of time. You don’t have to fix the whole person when all they ask for is some penicillin for their strep throat.

Sometimes you need to be quick and sometimes you need to be slow. Without the freedom to adapt, in a patient-centered way, to the situation, each patient presents with, primary care risks going under.

Hans Duvefelt, MD is a Swedish-born family physician in a small town in rural Maine. He blogs regularly at A Country Doctor Writes where this piece originally appeared.

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A Cross-Party Win: Empowering Consumers Through Digital Health

By LYGEIA RICCIARDI

Lygeia Ricciardi

These days Americans are more politically divided than ever, disagreeing vehemently about everything from guns to the role of the press. Despite the distrust and inflammatory rhetoric, there are examples of cross-party, trans-Administration collaboration and success. Let’s celebrate them and be motivated by what happens we put differences aside and focus on shared long-term goals.

Using digital technology to empower healthcare consumers is one example of a cross-party win, a still-developing success story that has been cultivated for more than a decade by the efforts of public and private sector leaders from a wide variety of affiliations and political perspectives.

Taking Healthcare Digital is a Cross-Party Achievement

Back in his 2004 State of the Union Address, Republican George W. Bush called for most Americans to have comprehensive digital health records within 10 years. “By computerizing health records, we can avoid dangerous medical mistakes, reduce costs, and improve care,” he said. Since then both political parties have built on the vision he laid out and added an important new twist—taking healthcare digital isn’t just about helping doctors do a better job, it’s also about empowering patients to be partners in their own health and healthcare.

In 2009 Congress allocated about $30 billion via the HITECH Act to expand and promote the adoption of health information technology, mostly through financial incentives for hospitals and doctors to migrate their medical records from manila folders to digital files. Through the resulting “meaningful use” program implemented mostly under Democrat Barack Obama, virtually every hospital and most doctors’ offices now have electronic health records systems (EHRs) which, in addition to laying the groundwork for a better traditional healthcare system, are required to have the capability to provide patients direct digital access to their own health records—effectively unleashing that data for any new kinds of uses available to and chosen by consumers.

Power to the People

Why would the average Joe or Jane want digital access to their health records anyway? For many reasons, from greater convenience (like easily getting the results of a medical test), to better health outcomes (for instance by avoiding medical errors by updating records to show which medications they are actually taking). With digital access to their own medical records, patients can also make sure the full array of people who support their health, often including multiple doctors, family members, and friends, are all on the same page, thus improving health outcomes and sometimes saving time and money in the process.

As of 2017, nearly a third of Americans had actually accessed their own health records online via a healthcare provider or insurer. Among those who did, 8 in 10 found the information easy to understand and useful.

The chart above shows what people who accessed their health information digitally did with it. While all of these activities are useful, it’s at the bottom of the chart where some of the most transformational untapped potential in empowering consumers with health data still lies.

Last year only 3% of people who accessed their health information digitally shared it with a service or app, but the conditions are right for dramatic growth in that area. While the traditional healthcare system has been converting over to digital, at the same time the public’s adoption of smartphones, apps, and wearables such as the Fitbit has been climbing. Smartphone use in the US is projected to surpass 250 million of the total population of 300 million in the next couple of years.

Enter the Tech Industry

Already 44% of smartphone and tablet owners report having a health or wellness app. About one-third own a health-related monitoring device such as a Fitbit, blood glucose monitor, or blood pressure monitor.

So far, most people haven’t linked the two… but industry innovators and investors are betting they will. Consumers supported by apps and tools can eat better, move more, remember to take medications, avoid stress, and make smarter healthcare spending decisions. All of which can benefit individual consumers and the healthcare providers and companies that want to serve them.

This year venture capital funding in digital health is projected to reach nearly a record-breaking $7 billion. And more established industry players are jumping into the fray as well, with 84% percent of the Fortune 50 Companies involved in healthcare, up from 76% in 2013.

Source: Rock Health, 2018

The Blue Button: An Inspiring Cross-Party Handoff

Last week the Trump White House hosted a forum on Blue Button 2.0 for technology developers. At the event, the Administrator of the Centers for Medicare and Medicaid Services (CMS), Seema Verma, encouraged developers to build apps and services leveraging data about 50 million Medicare beneficiaries that has recently been made more easily available via application program interface (API) standards through Blue Button 2.0, a part of the My HealthEData Initiative unveiled by Verma and Senior Advisor Jared Kushner last spring at the HIMSS conference, which will “help to break down the barriers that prevent patients from having electronic access and true control of their own health records from the device or application of their choice. This effort will approach the issue of healthcare data from the patient’s perspective.”

At the White House event, several large industry players including Amazon, Google, IBM, and Microsoft agreed to “actively engaging among open source and open standards communities” to further the goals of greater healthcare interoperability, in addition to “empowering patients.” It also included startups and industry analysts such as investor John Doerr, who spoke of the coming “dataquake” that will transform the healthcare industry.

Large-scale change like digitizing healthcare or shifting the role of the healthcare consumer doesn’t take place overnight. By definition it relies on the policy leadership of multiple Administrations and extended public-private partnerships. The Blue Button initiative began at the US Department of Veterans Affairs (VA) in 2010 and was enhanced and expanded by the Obama White House and other agencies, including the Office of the National Coordinator for Health IT, which collaborated with 60 industry partners to develop API standards for data sharing and led a pledge program in which more than 500 organizations agreed to share data easily with consumers and spread the word about the benefits of doing so. Numerous patient and pro-patient advocates continue to lend their voices to the effort through policy advice, stories, speeches, and art.

It’s exciting to see Blue Button and the broader concept of consumer empowerment continue not just to take root, but to flourish. Regardless of party affiliation or perspective in (or outside of) the traditional healthcare industry, let’s continue to collaborate in unleashing data for the benefit for all Americans. Better health, better economics… maybe even better cross-party collaboration in Washington—now that’s good for everyone’s health!

Lygeia Ricciardi is an expert in digital health and consumer engagement with Clear Voice Consulting. She started and led the Office of Consumer eHealth in the US Department of Health and Human Services from 2011 through 2014.  

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The UN’s Extreme Poverty Report: Further Evidence US Healthcare Is Divorced From Reality

By DAVID INTROCASO, Ph.D.

In May Philip Alston, the United Nation’s Special Rapporteur on Extreme Poverty, and John Norton Pomeroy Professor of Law at New York University Law School released his, “Report of the Special Rapporteur On Extreme Poverty and Human Rights on His Mission to the United States.”  The 20-page report was based, in part, on Alston’s visits this past December to California, Georgia, Puerto Rico, West Virginia and Washington, D.C.  After reading the report and the response to it, one is again forced to question how legitimate is our concern for the health and well being of the poor, or those disproportionately burdened with disease.

The UN report found over 40 million Americans live in poverty, or upwards of 14% of the population.  Those living in extreme poverty number 18.5 million and 5.3 million live in 3rd World absolute poverty.  Among other related statistics, Alston cites the fact the US has the highest comparable infant mortality rate, 50% higher than the OECD mean, due in part to an African American mortality rate that is 2.3 times higher than that of whites.  The US has the highest youth poverty rate in the OECD.  In 2016, 18% of children were living in poverty comprising 33% of all people in living poverty and 21% of those were homeless.  These facts are explained in part by the report noting between 1995 and 2012 there was a 750% increase in the number of children of single mothers experiencing annual $2-a-day poverty.  US poverty, the report explains is due in part to the continuing growth in income and wealth inequality.  The report found in 2016 the top 1% possessed 39% of the nation’s wealth while the bottom 90% lost 25% of its share of wealth and income.  Since 1980 annual income for the top 1% has risen 205% and for the top .1% by 636% while annual wages for the bottom 50% have stagnated.  The report reminds us the US has approximately 5% of the world’s population but 25% of its billionaires.  The US in sum ranks 18th out of 21 wealthy countries in labor markets, poverty rates, safety nets, wealth inequality and economic mobility.

While the statistics Alston presents are sobering, his assessment of the evidence is unsparing.  “Successive administrations including the current one,” Alston writes, “have determinedly rejected the idea that economic and social rights are full-fledged human rights . . . .  International human rights law recognizes a right to education, a right to health care, a right to social protection of those in need and a right to an adequate standard of living.  In practice, the United States is alone among developed countries in insisting that while human rights are fundamental importance, they do not include rights that guard against dying of hunger, dying from lack of access to affordable health care or growing up in a context of total deprivation.”  These rights have been ignored because, “for almost five decades the overall policy response has been neglectful at best, but the policies pursued over the past year seem deliberately designed to remove basic protections from the poorest, punish those who are not in employment and make even basic health care into a privilege to be earned rather than a right of citizenship.” This is particularly disturbing because, “in a rich country like the US,” Alston writes, “the persistence of extreme poverty is a political choice made by those in power.”  Alston concludes his report by noting that while “in the US it is poverty that needs to be arrested not the poor simply for being poor,” “the United States already leads the developed world in income and wealth inequality, and it is now moving full steam ahead to make itself even more unequal.”

The Trump administration’s response to the UN report was unsurprising.  On June 21st, or the day before Alston presented his findings to the UN Human Rights Council meeting in Geneva,  US Ambassador to the UN, Nikki Haley, in a letter in response to Senator Bernie Sanders and 20 other Congressional members, argued it is “patently ridiculous for the UN to examine poverty in America.”  Two days before that, the US withdrew from the Council calling it a “cesspool of bias.”  The decision to withdraw was also unsurprising.  The US has at best a mixed record on human rights.  For example, though 150 other countries have done so, the US has yet to ratify the 1966 International Covenant on Economic, Social and Cultural Rights that protects the right to health, an adequate standard of living and other human rights.

The correlation between poverty and disease, or the social determinants of health, are well documented.  Nevertheless, Kaiser Health News, Inside Health Policy, Politico and other major healthcare media outlets chose not to cover the UN report.  It is worth noting the report was also ignored by prominent healthcare trade associations including the American Medical Association (AMA), the American Hospital Association (AHA) and America’s Health Insurance Plans (AHIP).  This, again, is unsurprising.  These organizations similarly ignored the Human Rights Watch’s (HRW) February report, “They Want Docile, How Nursing Homes in the United States Overmedicate People With Dementia.”  The report documented the continuing massive misuse of antipsychotics in nursing homes that, HRW concluded, “are inconsistent with human rights norms.”  These organizations also have had nothing to say about seemingly never-ending reports of childhood sexual abuse including the 2016 revelation that former House Speaker, Dennis Hastert, sexually molested boys while employed as a high school wrestling coach.  The AMA still honors Hastert as the 2006 Nathan Davis awardee for “the betterment of the public health.”  (Ohio House Republican, Jim Jordan, is currently accused of ignoring the sexual assault of Ohio State wrestlers he coached.)  The organizations also continue to ignore global warming that will continue to have an increasingly disproportionate adverse impact on the poor.  For example, these organizations were silent when the Obama administration released its exhaustive 2016 report, “The Impacts of Climate Change on Human Health in the United States: A Scientific Assessment.”

Indifference aside, in his report Alston argues further the US relies “on criminalization to conceal the underlying poverty problem.”  He characterizes the US criminal justice system as one that is “effectively a system for keeping the poor in poverty.”  For example, he notes in 2016 LA police arrested 14,000 homeless persons, an increase of 31% over 2011, while city arrests overall decreased by 15%.  These arrests for minor infractions like public urination in a city that fails to even meet the minimum standard number of toilets the UN sets for emergency situations, lead to misdemeanors, to warrants, to incarceration, to un-payable fines or bail and to criminal convictions that ultimately prevent employment and access to housing.  “Punishing and imprisoning the poor,” particularly the homeless, he writes, “is the distinctly American response to poverty in the twenty-first century.”  This century’s response is a continuation of last century’s response to imprison a large portion of the US population even before Bill Clinton’s 1994 Violent Crime Control and Law Enforcement Act contributed to the further criminalization of the poor and the era of mass incarceration.  The US, again with approximately 5% of the world’s population, currently accounts for over 20% of the worlds prisoners, or over 2 million, who are moreover poor and disproportionately African American and Hispanic.

The criminal justice system is used Alston notes to “make social problems temporarily invisible and to create the mirage of something having been done.”  This is exactly right when you consider how the US largely addresses mental illness.  It’s an arrestable offense.  Today, US prisons and jails constitute the largest providers of housing, or warehousing, for the mentally ill.  In her recent work, “Insane, America’s Criminal Treatment of Mental Illness,” Alisa Roth notes approximately 50% of those incarcerated, and over 75% of women incarcerated, have a mental illness.  Approximately 80% also have an accompanying substance use disorder that explains, in part, why they are incarcerated.  Roth finds the treatment these inmates receive is terrible.   One of her chapters is titled “sanctioned torture.” In his investigations of prisons the forensic psychiatrist, Dr. Terry Kupers, has found conditions where “prisoners are isolated, abandoned, forced to live in abject filth and darkness, subjected to violence and danger, denied care for the most basic human needs.”   Mental illness, as one prison official candidly tells Roth, is the new Jim Crow.

If both imprisoning the mentally ill and ignoring or denying them medical treatment does not beg human rights concerns, torturing them should.  Though the practice became viewed as cruel 200 years ago, Tocqueville and Dickens criticized the practice as well the Supreme Court in an 1890 case, today on any given day between 80,000 and 120,000 men, women and children are held in solitary confinement in US prisons and jails even though no court ever sentences anyone to solitary and those in isolation, even those held in isolation for decades, are without any due process rights.  Approximately one-third of individuals placed in “the box” suffer mental illness and a similar percent develop psychiatric symptoms if not complete decompensation after being confined over an extended period.  While those in isolation make up 5% of the general prison population they account for over 50% of suicides by, for example, self-amputation of the testicles, biting through the veins in the wrist or by jumping headlong off a bunk.  In 2011 the UN’s Special Rapporteur on Torture, Juan E. Mendez, a victim of solitary confinement himself, concluded the practice of solitary confinement be absolutely prohibited for those with mental illness and juveniles and limited to no more than 15 days for others.

He wrote, “Considering the severe mental pain or suffering solitary confinement may cause, it can amount to torture or cruel, inhuman or degrading treatment of punishment.” In their 2016 edited work, “Hell is A Very Small Place, Voices of Solitary Confinement,” Jean Casella and her coauthors moreover offered 16 first-person accounts by current or former long-term solitary confinement inmates.  William Blake, who has been held in isolation for three decades summarized his experience by writing, “set me afire, pummel and bludgeon me, cut me to bits, stab me, shoot me, do what you will in the worst of ways, but none of it could come close to making me feel things as cumulatively horrifying as what I’ve experienced through my years in solitary.”

When not criminalizing the poor state human services agencies in partnership with private sector contractors monetize poverty or turn the poor into a source of revenue.  Daniel Hatcher’s 2016 work, “The Poverty Industry, The Exploitation of America’s Most Vulnerable Citizens,” details at length how, for example, foster children have become “revenue generating mechanisms” by state agencies by, for example, presumptively assigning the state the role of the foster child’s representative Social Security insurance payee.  The poor are also exploited under rampant Medicaid money laundering schemes, for example, through the use of so-called bed taxes, enhancement or quality assessment fees used to fund state agency maintenance fees or state programs entirely unrelated to Medicaid.

Concerning the adverse health effects of rising wealth inequality described by Alston as “a dramatic contrast between the immense wealth of the few and the squalor and deprivation in which vast number of Americans exist,” the healthcare sector appears unmoved or indifferent.  For example, when Thomas Piketty’s highly acclaimed and influential “Capital in the Twenty-First Century” was published in 2014, where he argued the US is on a path back to patrimonial capitalism and where concentrated wealth and social programs like healthcare insurance are incompatible, the work was ignored in healthcare policy circles.  For example, the sole mention of Piketty in Health Affairs was a blog post that noted Piketty “is French, after all” and to argue income inequality “might be a good thing for sustainable health care spending.”  How healthcare is designed and delivered in the US also remains ignorant of the realities of being poor.  Leaving aside continuing efforts to dismantle the Affordable Care Act, more than anything it is impossible to believe US healthcare presumes an option for the poor.  Dr. Elisabeth Rosenthal begins her 2017 work, An American Sickness, How Healthcare Became Big Business and How You Can Take It Back,” by candidly admitting, “the American medical system has stopped focusing on healthcare or even science. Instead, it attends more or less single-mindedly to its own profits.”  In dollars, this means Americans are every year forced to pay approximately $1 trillion in low or no value healthcare.   It is no wonder why health care is increasingly unaffordable for not just the poor.

In his 2017 work, “The Moral Economists, R. H. Tawney, Karl Polanyi, E. P. Thompson, and the Critique of Capitalism,” Tim Rogan explained “single-mindedness” has its origins in the late 18th century.  Via the works of T. R. Malthus, David Ricardo and Joseph Townsend western political economy became estranged from moral rules. Utilitarian reasoning became inexorable.  As for poverty, Townsend argued in his 1786 “Dissertation on the Poor Laws,” it should be left to the cruelties of nature.  This perspective, that our only interests are our self-interests, persists.  It explains why, as Alston noted in a June 3 Huffington Post editorial, the administration wants to gratuitously triple rents, cut food stamp funding and allow states to drop Medicaid lives.  This perspective, however, leaves us, as Umair Haque observed last year, without moral universals or public goods everyone should have including healthcare, welfare, education, and transportation.  These civilize us. They would allow, for example, the recently injured Boston subway commuter to afford emergency care.  They also allow for democracy and upon which democracy depends.

David Introcaso, Ph.D., has been doing health care delivery, payment and related research in Washington, D.C. for over twenty years at, for example, AHRQ and ASPE, for Congressional leadership and for numerous trade and professional organizations from the American Heart Association and the American Public Health Association to UnitedHealth Group.

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Seema Verma Hyperventilates About Tiny Differences Between ACOs Exposed to One-and Two-Sided Risk

By KIP SULLIVAN, JD

Kip Sullivan, JD

There is no meaningful difference between the performance of Medicare ACOs that accept only upside risk (the chance to make money) and ACOs that accept both up- and downside risk (the risk of losing money). But CMS’s administrator, Seema Verma, thinks otherwise. According to her, one-sided ACOs are raising Medicare’s costs while two-sided ACOs are saving “significant” amounts of money. She is so sure of this that she is altering the rules of the Medicare Shared Savings Program (MSSP). Currently only 18 percent of MSSP ACOs accept two-sided risk. That will change next year. According to a proposed rule CMS published on August 9, ACOs will have at most two years to participate in the MSSP exposed to upside risk only, and after that they must accept two-sided risk.

That same day, Verma published an essay on the Health Affairs blog in which she revealed, presumably unwittingly, how little evidence she has to support her decision. The data Verma published in that essay revealed that one-sided ACOs are raising Medicare’s costs by six-one-hundredths of a percent while two-sided ACOs are cutting Medicare’s costs by seven-tenths of a percent. [1] Because these figures do not consider the expenses ACOs incur, and because the algorithms CMS uses to assign patients to ACOs and to calculate ACO expenditure targets and actual performance are so complex, this microscopic difference is meaningless.

“Two beellion dawlers”

Even if the difference is not meaningless – even if two-sided ACOs actually save a few tenths of a percent for Medicare – the impact on Medicare spending will be barely noticeable. Verma assures us, without a hint of embarrassment, that her new rule will cut Medicare spending by $2.2 billion over ten years. “The projected impact of the proposal would be savings to Medicare of $2.2 billion over ten years,” she declares in her blog comment.

Dr. Evil from Austin Powers

I feel like we’re in a scene from the Austin Powers movie where Dr. Evil announces he will hold the world ransom for “one meellion dawlers.” Dr. Evil’s sidekick, Number Two, has to advise him that a million dollars is peanuts. Verma’s estimate of 2.2 “beellion dawlers” is essentially zero percent of the trillions of dollars CMS will spend on Medicare in the next decade.

As pathetic as these figures are, they fail to take into account ACO start-up and operating costs. CMS doesn’t know or care what those costs are. The only relevant information we have are some undocumented statements by the staff of the Medicare Payment Advisory Commission (MedPAC) to the effect that ACO overhead is about 2 percent of their benchmarks (their predicted spending). [2] I suspect 2 percent is low, but let’s take it at face value and do the math. If, as Verma’s data indicates, two-sided ACOs save Medicare seven-tenths of a percent net (that is, considering both CMS’s shared-savings payments to some ACOs and penalties other ACOs that lose money pay to CMS), but these ACOs spend 2 percent doing whatever it is ACOs do, that means the average two-sided ACO is losing one percent.

Is it any wonder Clif Gaus, director of the ACO trade group NAACOS, said Verma’s proposed rule “defies logic” and will “pull the rug out from under” the MSSP? In a press release, Gaus cited a survey indicating 70 percent of ACOs will bail out of the MSSP program if they are forced into two-sided risk contracts in 2019. That is much higher than the 20 percent dropout rate predicted by CMS.

The good news is that Verma may have hastened the demise of a program that isn’t working. Whether Congress ultimately pulls the plug on the ACO project will depend on whether ACO advocates will concede at some point that the ACO fad was based on faith, not evidence, and has failed to work. I predict they will refuse to admit failure and will instead peddle another equally ineffective solution, for example, overpaying ACOs (as the Medicare Advantage insurers and their predecessors have been for the last half-century). I base my prediction on the behavior of ACO advocates. The history of the ACO movement indicates ACO proponents don’t make decisions based on evidence. Let me review that history for you.

Levitating a Lead Balloon

From the moment the ACO concept was born, evidence has not mattered to ACO proponents. The ACO concept was conceived during a conversation between Elliott Fisher and members of MedPAC at their November 9, 2006 meeting. Fisher presented a flabby definition of the ACO to the commission, he failed to describe a single mechanism by which it would cut costs or improve care, and he offered no evidence that this vaguely defined thing would work. And MedPAC swallowed it.

MedPAC has been an enthusiastic proponent of ACOs ever since. The failure of CMS’s pilot test of the ACO notion, the Physician Group Practice (PGP) Demonstration (it ran from 2005 to 2010), did not diminish MedPAC’s faith in the ACO. The final evaluation of the PGP demo, published in 2012, found that the ten PGPs (which were exposed to a version of two-sided risk) saved Medicare a grand total of three-tenths of a percent over the 2005-2010 period. [3]

MedPAC avoided discussing the possibility that its cherished ACO might be a lead balloon until the fall of 2016, that is to say, ten years after they concocted the ACO, seven years after congressional Democrats wrote ACOs into the legislation that would become the Affordable Care Act, and four years after CMS initiated the Pioneer and MSSP ACO programs authorized by the Affordable Care Act. At its October 6, 2016 meeting, MedPAC staffer David Glass reported that the Pioneer program (which ran from 2012 to 2016) and the MSSP had together raised Medicare’s costs in 2015 by three-tenths of a percent net (see pp. 6-7 of the transcript of the morning session.) [4]

The commission was disturbed by this report. Several commissioners asked the staff why some ACOs were saving money and others weren’t. The staff expressed doubt that they would ever be able to answer that question. The most helpful comment the staff could come up with was this one by Jeff Stensland in response to a question from commission member Jack Hoadley about why some ACOs dropped out of the Pioneer and MSSP programs. “If you look who drops out, it’s they didn’t make money. If you made money, even if you don’t know why, you stay in,” said Stensland (p. 41 of the transcript in the morning session of the October 6, 2016 meeting). Should we be surprised by the uselessness of that tautological answer? If Fisher and MedPAC never defined the mechanisms by which ACOs were supposed to work their magic, how are the poor staff supposed to explain why some ACOs fail and others succeed?

But over the next year, MedPAC staff came up with what they deemed to be a satisfactory answer – exposing ACOs to more risk will make them save money. Why? Who knows? They didn’t say. Commissioner David Nerenz at one point challenged the staff to explain the mechanism by which two-sided risk might cause ACOs to improve their performance, but they did not respond. At the January 12, 2018 meeting, staff presented slides that showed miniscule differences between one- and two-sided-risk ACOs (see slides 9 and 12 here) and they implied there was some causal connection. Elliott Fisher reinforced this new folklore in an article in the New England Journal of Medicine published in November 2017. “[P]roviders know how to save money,” he and his co-authors intoned, “but they need financial motivation to change their behavior.” Ergo, CMS should switch all ACOs to two-sided risk. As is the norm among ACO proponents, Fisher et al. provided no evidence for this claim.

Despite the tiny differences in the performance of the two types of ACOs, and despite the complete absence of evidence on the mechanism that might have caused these tiny differences, MedPAC bought the advice of their staff, Fisher and other ACO proponents, and decided to celebrate two-sided ACOs in their next report to Congress. “[T]wo-sided ACO models appear to save more than one-sided ACO models,” said the commission in its June 2018 report to Congress (p. 211). They went on to suggest that spending more money on two-sided ACOs would induce more ACOs to accept two-sided risk, and this in turn might save money despite the higher subsidies to ACOs.

By the spring of 2018, the evidence-free claim that exposure to greater risk would improve the performance of MSSP ACOs was hardening into conventional wisdom. That spring Trump administration officials made announcements indicating they too were accepting the new folklore. CMS’s proposed new rule, posted on August 9, and accompanying statements by Verma, made it official. Here is how CMS articulated the new folklore in their proposed rule:

ACOs in two-sided models have shown significant savings to [sic] the Medicare program…. Even more concerning is the finding that one-sided model ACOs, which are not accountable for sharing in losses, have actually increased Medicare spending relative to their benchmarks. Further, the presence of an “upside-only” track may be encouraging consolidation in the marketplace, reducing competition…. [pp. 6-7]

The only accurate statement in that paragraph is the statement that one-sided ACOs have increased Medicare spending. The claim that one-sided ACOs may be encouraging consolidation is accurate, but CMS’s failure to say the same about two-sided ACOs is irrational.

Facing the Evidence

Evidence that the ACO project is failing is piling up. All three of CMS’s two-sided ACO programs – the PGP demo, the Pioneer demo, and the Next Generation program – saved only a few tenths of a percent, while CMS’s mostly two-sided program, the MSSP, raised costs by a smidgeon. All four programs have raised costs if we take into account the ACOs’ start-up and operating costs and CMS’s cost of administering these complex programs. [5] Evidence indicting the other major “value-based payment” fads – medical homes, bundled payments [6], and pay-for-performance schemes– is also piling up. The simultaneous failure of all these fads to cut costs spells trouble ahead for the Affordable Care Act (because it relies on “value-based payment reforms” for cost containment), MACRA (because it also relies on “value-based payment” theology), and our entire health care system (because the big insurance companies and the major hospital-clinic chains are spending more money on “value-based payment” fads than those fads are saving, and because these 1,000-pound gorillas are using the establishment’s endorsement of ACOs, medical homes etc. as an excuse to become 2,000-pound gorillas).

The root cause of our nation’s chronic inability to adopt effective cost-containment policies is the chronic inability of the American health policy establishment to make decisions based on evidence, not groupthink. Seema Verma’s decision to bet the farm on two-sided-risk ACOs is the latest example of this problem.

[1] I derived these percentages from the dollar figures Verma presented in two exhibits in her comment on the Health Affairs blog. Exhibit 1 indicates “all upside-only ACOs” raised Medicare spending by a net of $0.049 billion in 2016 compared with $76.718 billion in expected (benchmark) spending for those ACOs in 2016. The net increase, therefore, amounts to 6 one-hundredths of 1 percent. Similarly, the data Verma presents in Exhibit 4 indicates “two-sided ACOs” saved $0.033 billion in 2016 compared with expected spending of $4.659 billion, or seven-tenths of a percent.

Readers can find nearly identical data in Chapter 8 of MedPAC’s June 2018 report to Congress. Unlike Ms. Verma’s data in her Health Affairs essay, which is broken out by one-sided versus two-sided ACOs, the MedPAC figures are broken out by program – Pioneer, MSSP, and the recently started Next Generation. MedPAC’s tables show that the MSSP program raised costs by one-to-three-tenths of a percent over the period 2013-2016, while the small two-sided ACO programs performed almost as miserably. The two-sided Pioneer program averaged savings of only a few tenths of a percent over the 2012-2016 period, and its successor, the two-sided NextGen program, achieved a savings of two-tenths of a percent in its first year (2016). The table below summarizes these results.

===================================================

Table 1: Net savings/losses as a percent of total Medicare spending by ACOs according to CMS

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[2] MedPAC staff have testified at several MedPAC meetings that ACO overhead is 1 to 2 percent of ACO Medicare revenues. MedPAC stated in its June 2018 report to Congress that the per enrollee overhead of ACOs is about $200 (p. 236). That equals a little less than 2 percent of the annual cost of insuring a Medicare beneficiary.

[3] The gross savings and the cost to CMS of the PGP demo are reported at page 64 of the final evaluation.

The physician group practices that participated in the Physician Group Practice demo were exposed to a form of two-sided risk that was slightly different from the version used in the Pioneer ACO demonstration and which is being proposed by Verma for the MSSP. In the PGP demo, the PGPs were not penalized in any given year if they went over their target (their benchmark), but if they saved money in the following year the amount of their shared savings would be reduced by whatever amount they went over budget the previous year.

[4] See footnote 1 of my comment here for an explanation of how I derived the three-tenths-of-a-percent figure based on the dollar figures Glass reported.

[5] There are some who argue that three or four articles in the peer-reviewed literature demonstrate that ACOs are saving a percent or two more than CMS’s data shows. MedPAC is among them; Verma obviously is not. MedPAC summarized the evidence for this argument in Chapter 8 of their June 2018 report to Congress. Their argument was not convincing. Only two studies MedPAC cited reported net savings (both were studies for which Michael McWilliams was the author or one of the authors). Those studies reported a net savings of a mere seven-tenths of a percent for the MSSP and three-tenths of a percent for the Pioneer program.

[6] The exception to the statement that bundled payments are failing appears to be bundled payment for joint and hip replacement. But the reason appears to be reduced prices of artificial joints achieved by the exercise of excessive market power by hospitals, not reduced utilization of services. If we want to reduce prices of medical goods and services, we should do it uniformly via negotiations between CMS and providers, and not let the race to gigantism determine who benefits from bundled payment.

Kip Sullivan chairs the Policy Advisory Committee of Health Care For All MN, and is a member of the Minnesota chapter of Physicians for a National Health Program. 

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