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John Irvine

The ACO Information Vacuum

flying cadeuciiIn my three-part series on why we know so little about ACOs, I presented three arguments:

  1. We have no useful information on what ACOs do for patients;
  2. that’s because the definition of “ACO” is not a definition but an expression of hope; and
  3. the ACO’s useless definition is due to dysfunctional habits of thought within the managed care movement that have spread throughout the health policy community.

Judging from the comments from THCB readers, there is no disagreement about points 1 and 3. With one exception (David Introcaso), no one took issue with point 2 either. Introcaso  agreed with point 1 (we have no useful information on ACOs), but he argued that the ACO has been well defined by CMS regulations, and CMS, not the amorphous definition of “ACO,” is the reason researchers have failed to produce useful information on ACOs.

Another reply by Michael Millenson did not challenge any of the three points I made. Millenson’s point was that people outside the managed care movement use manipulative labels so what’s the problem?

I’ll reply first to Introcaso’s post, and then Millenson’s. I’ll close with a plea for more focus on specific solutions to specific problems and less tolerance for the unnecessarily abstract diagnoses and prescriptions (such as ACOs) celebrated today by far too many health policy analysts.

Summary of Introcaso’s comment and my response

I want to state at the outset I agree wholeheartedly with Introcaso’s statement that something is very wrong at CMS. I don’t agree with his rationale, but his characterization of CMS as an obfuscator is correct.

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A New Federal Agency to Oversee Patient Safety?

flying cadeuciiPatient safety should be a major priority for the United States, and that requires designating a centralized entity or coordinating body to oversee efforts to ensure it. Such centralized oversight is one of the key recommendations of “Free from Harm,” a report published in December by the National Patient Safety Foundation. The report highlights the need to create a safety culture, since preventable medical errors in hospitals are estimated to result in as many as 440,000 deaths annually. That would make it the third leading cause of death – after heart disease and cancer.

A new report by the U.S. Government Accounting Office illuminates the challenges that hospitals face in implementing evidence-based safety practices. One of those challenges – determining which patient safety practices should be implemented – underscores the need for a coordinating entity and resource. The report states: “(Hospital) Officials noted that they face challenges identifying which evidence-based patient safety practices should be implemented in their own hospitals, such as when only limited evidence exists on which practices are effective. For example, officials from one hospital told GAO that the hospital tried several different practices in an effort to reduce patient falls without knowing which, if any, would prove effective.”

What’s more, preventing medical errors in hospitals is only part of the national challenge, as most health care is provided outside of hospital settings: in physicians’ offices and clinics; in outpatient surgical, medical, and imaging centers; and, in long-term, hospice, and home-care settings, among others. There are about 1 billion ambulatory visits each year in the United States, compared to 35 million hospital admissions. Those ambulatory settings are subject to medical errors as well. According to studies cited in “Free from Harm,” more than half of annual, paid, medical malpractice claims were for events in the outpatient setting.

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In Defense of Small Data

flying cadeuciiI read with interest a recent editorial that opined on the poor evidence for screening in cancer trials. The evidence was judged poor because apparently no screening trial has demonstrated a clear reduction in all-cause mortality, only disease-specific mortality.  One example discussed in the analysis reviews the data for colon cancer screening and notes that, while there were a statistically significant lower number of deaths related to colon cancer in the screened group, the total mortality in the two groups was no different.  The authors posit that the study is either underpowered for total mortality or that the screened patients may have more deaths due to the ‘downstream effects’ of screening.  The provocative conclusion by many a tweet and retweet is that cancer screening has not been shown to save lives. Apparently the path to progress in medicine now must be paved by studies with millions of patients.  I understand the desire for more and more data, but I see danger in the sanctimonious protestations of those who can only find truth within the confines of a million-person, randomized control trial.  This approach ignores the history of advances in clinical medicine, most of which live far outside of the boundaries of million-strong randomized clinical trials.

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Why We Know so Little About ACOs: The Managed Care Culture at Work

flying cadeuciiThis is the third essay in a three-part series in which I explore the answer to that question. In the first installment  I blamed this problem on the flimsy definition of “ACO.” ACO proponents “defined” the ACO in terms of their hopes for it, not in terms of the mechanisms ACOs would use to accomplish those hopes.

In the second installment  I reviewed a paper published by the Center for Health Care Strategies (CHCS) to document my statement that we have no useful information on ACOs and to illustrate the quandary the hope-based “definition” of “ACO” creates for researchers. I criticized the CHCS paper as well for its cavalier attitude about evidence. The paper relied heavily on press releases and anonymous sources, and ignored the costs providers and insurers incur to set up and maintain ACOs.

In this last installment, I explore the role that culture – the culture of the managed care movement and the larger health policy community – played in elevating the ACO to the status of national health policy and, at the same time, thwarting the production of useful research on what it is ACOs do for patients.

The ACO isn’t the only example of hope-based health policy

If the ACO were the only example of an undocumented and poorly defined health care “reform” that was flogged from obscurity to fame by a few well-placed health policy entrepreneurs, we might dismiss the problems created by the flabby definition of the ACO as an aberration. But the ACO is not the only example of such “reforms.”

To the contrary, the ACO illustrates the norm, not the exception. It is an excellent illustration of how health policy has been made in America since the modern health care reform debate began circa 1970. Over the last half-century, every managed care “reform” that was eventually unleashed on all or large portions of the American populace followed the trajectory of the ACO:

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More on MACRA, Interoperability and the Post-Meaningful Use World

By ANDY SLAVITT

Screen Shot 2016-03-04 at 11.34.56 AMTHCB is pleased to feature acting CMS administrator Andy Slavitt’s comments during a panel appearance at this week’s HIMSS conference. We encourage you to read them closely and with an open mind and add your own thoughts on the steps you think the government should take to improve the federal quality measurement program and improve and promote health information technology. For more on the topic of EHR incentives and the transition from the Meaningful Use program, go read Andy’s last THCB post “EHR Incentive Programs: Where We Go From Here.”

I love working with Karen De Salvo. She can talk in half sentences and I can finish them. We’ve naturally been working together for months on some of the initiatives we’re talking about here, and always check in to compare facts, see if we’re seeing the same thing. We went into these speeches in perfect harmony on what needs to be done.

True story. We exchange drafts and she sends me a note “Andy, I think your speech comes across as very negative. Why don’t you reread with that lens?” I erased the email I’d been writing to her– she’s always too positive for me anyway – and I think I sent her an emoticon of a happy face instead. Now one interpretation is she works with the technology community who by all accounts and from looking around the floor are generally happy. I hear more from docs trying to use technology and that may affect my moods a little bit.

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Mr.Trump’s Proposal for the Sale of Health Insurance Across State Lines

Donald Trump’s website has a position paper entitled “Healthcare Reform To Make America Great Again.”  And some of his suggested reforms make sense.  However, the question of the moment involves Item 2:

“Modify existing law that inhibits the sale of health insurance across state lines.  As long as the plan purchased complies with state requirements, any vendor ought to be able to offer insurance in any state.  By allowing full competition in this market, insurance costs will go down and consumer satisfaction will go up.”

This is not by any means a new proposal.  Despite being supported by most Republican Presidential candidates, it has lingered around for decades without going anywhere.  And for good reason.

The driving argument is that this would permit increased competition amongst insurers which would lower premiums.  While it is true that competition might increase, it is highly doubtful that the result would be lower premiums, and there are considerable consumer protection concerns as well.

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The Meme-ifcation of Health Care

flying cadeuciiWhy can’t we have nice things? As a self-anointed health policy wonk, I find myself asking this question many times. It seems that every potentially transformative (to use a tired cliché) health care trend must eventually go through a process I’ll call “meme-ification.” And I’ll preface by saying that this applies across the political spectrum.

Take the hobby horse of many progressive reformers – single payer. If you’ve spent any time immersed in health care policy, you’ve probably heard it all: every other advanced country does it, insurance companies (and profits) are evil, health care can’t be a for-profit (evil) industry etcetera.

Of course, if you’ve spent any time immersed in health care policy you probably also understand that attempting to extrapolate lessons from the U.K. (relatively homogeneous, over 250 people per square kilometer, and about 1 homicide per 100,000) to the U.S. (about as diverse as you can imagine, about 35 people per square kilometer, and nearly five homicides per 100,000) is at best, an uphill battle.

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What Trump’s Plan to Negotiate With Pharma Should Tell Us

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Donald Trump’s proposal to allow the federal Medicare program to negotiate prices with drug companies should be a wake-up call for the pharmaceutical industry.

Trump is leading in the polls for the Republican nomination and is even drawing the support of Tea Party conservatives who, just a year or two ago, never would have supported a candidate endorsing such strong government intervention into a private-sector industry.

Characteristically, Trump didn’t give a lot of detail about his plans. He claimed $300 billion in savings per year (about 10 times more than is realistic). But that doesn’t matter. If the leading GOP presidential candidate—a man who has proved masterful at reading the public mood and playing to it—has signed on to this idea, it proves that change has come.

I know that many veterans of the pharmaceutical industry think they have seen this horror movie before and know how it ends. There have been several past public furors over the price of prescription drugs, and each one gradually faded without major disruption for drugmakers. But this time feels different.

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Cancer and the Politics of Moonshots

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As many of the Republican and Democratic presidential candidates lament the high cost of healthcare and put forth how they aim to make it more cost effective, few have focused on the impact of out-of-pocket costs specifically for cancer patients. They should. One in every two men and one in every three women will get cancer at some point over their lifetime. As the U.S. population and American lifespans increase, this toll will have major financial ramification for everyone.

When fighting against the disease, cancer patients are often at the mercy of the pharmaceutical industry. Given Pfizer’s recent announcement that it plans to merge with Allergan, making it the largest pharmaceutical company in the world, many cancer patients are wondering what this will mean in terms of their cost of care. Pfizer, a giant in the cancer pharma space, already raised prices on 133 of its brand-name drugs last year, and they are not alone.  Big pharma has raised cancer drug prices up to 5000%. Recently ousted Turing CEO Martin Shkreli justified such hikes explaining, “I could have raised [prices] higher and made more profits for our shareholders, which is my primary duty.” The lack of focus on patients spawned outrage amongst patients, providers and even politicians, but the drug industry seems to be “in denial of the seriousness of its pricing problem.”

Granted, drug production takes years of research and can cost $350 million to get a single drug to market. Considering 95% of the experimental drugs will never see a pharmacy shelf, it might seem reasonable that the cost to patients is on the increase.  But contrary to the pharmaceutical industry’s claims, the cost of innovation is not the driver of drug prices. A study published in JAMA Oncology found that prices of cancer drugs are not tied to novelty nor to effectiveness, but rather set to what the market can bear. Here within lies the problem: if you’re a patient faced with a cancer diagnosis, wouldn’t you pay whatever the cost, no matter the price?

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Apple and the 3 Kinds of Privacy Policies

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Why Are Apple’s Competitors Staying Silent On the iPhone Unlocking Fight? is the question of the day on tech blogs. The answer is hardly technical and may not be legal, it’s all about privacy policies and business strategy and it is very evident in healthcare.

There are three classes of privacy policy in healthcare and everywhere else:

Class 1 – “Apple will not see your data.” This is Apple’s privacy policy for ResearchKit and HealthKit and apparently for whatever data the FBI is hoping to read from the terrorist’s phone. Obviously, in this case the person is in complete control of the data and it can be shared only with third-parties that the person authorizes.

Class 2 – “We will see and potentially use your data but you will have first-class access to your data”. This is the kind of privacy policy we see with Apple’s calendar and many Google services. The personal data is accessible to the service provider but it is also completely accessible via an interface or API. In healthcare, the equivalent would be having the FHIR API equally and completely accessible to patients and to _any_ third-parties authorized by the patient. This is Patient Privacy Rights’ recommendation as presented to the API Task Force.

Class 3 – “We will use your data according to xyz policy and if you don’t like it, take your illness elsewhere.” This is pretty much how healthcare and much of the Web world runs today. We have limited rights to our own data. On the other hand, the services that have our data can sell it and profit in dozens of ways. This includes selling de-identified data. In Class 3, you, the subject of the data are a third-class citizen, at best. In many cases, the subject doesn’t even know that the data exists. See, for example, The Data Map.

We are so completely engulfed by Class 3 privacy policies that we have lost perspective on what could or should be. A Class 1 policy like Apple’s is widely seen as un-American. A Class 2 policy like PPR’s is indirectly attacked as “insurmountable”.

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