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Why PCORI Should Be Very Wary of Studying Medical Devices

In the New York Times on Thursday, October 17, Topher Spiro wrote an important op-ed expressing why we need to hold onto the medical device tax that helps pay for parts of the Affordable Care Act. Spiro backs up his argument by pointing out how profitable the device industry is. To his argument I would also add the fact that this will provide the industry with more paying customers. Certainly it can afford to pay the taxes.

But I diverge from Spiro on a proposal he floated near the end of his piece:

“To complement these efforts, the new Patient-Centered Outcomes Research Institute [PCORI], a non-governmental body created by the Affordable Care Act, should pay for research that compares the effectiveness of devices so physicians can make informed choices. (Three years into its existence, the institute has initiated few, if any, studies of medical devices.”

Listen to me PCORI. Don’t follow this advice, unless you plan not to survive to celebrate your fourth birthday.

Consider what happened to the Agency for Healthcare Policy Research (AHCPR), when it tried to help physicians figure out the best way to treat low back pain. AHCPR was created as a stand-alone research institute, akin to the NIH, but one that would focus not on the basic science of treating disease, but instead on evaluating how well existing treatments worked.

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A Pragmatic Fix for Healthcare.gov & the HIXs

By MATTHEW HOLT

By now even those of us who originally thought that we were seeing minor teething troubles are no longer deluding ourselves. Healthcare.gov, the federal health insurance exchanges (HIXs), and many of the state HIXs are in deep trouble.

One summary of many articles about this is up at ProPublica. But now that the House Republicans have stopped trying to destroy the country and themselves, attention will turn quickly to this problem, and–much worse–beyond the politics, there is now only eight or so weeks to get ready for actual enrollments for Jan 1, once you take out Thanksgiving and the Christmas holiday. Getting ten or twenty million new customers on board, not to mention the small businesses who want to move from their current insurance onto the exchanges, seems like an impossible task.

But, if we can muster the will, there may be a solution. (And yes, I want it to work, faut de mieux). Quietly last summer two private online insurance brokers, eHealth which runs the eHealthInsurance.com site, and GetInsured, struck deals with HHS which allowed them to enroll individuals in plans that qualify for the mandate under the ACA, and more importantly, connect with the “Health Exchange Data Hub” that figures out whether the enrollee qualifies for a subsidy (theoretically by connecting to the IRS).

That part of the transaction, though, could be done by attestation and dealt with later. In other words, someone buying health insurance could state what their income will be in 2014 (or was in 2013) and if it ends up varying dramatically on their 1040 then in 2015 they will pay or receive the difference. Essentially this is something all Americans recognize–the IRS asks you for more or gives you a tax refund well after the fact, and H&R Block and their competitors make a business of giving you the refund right away (and of course charge you for the privilege).

That is important because what seems to be crippling the HIXs right now is not the back end, it’s the front end. (Go to this Reddit thread for lots more deeply technical conversation about that). Showing people options, comparing plans, setting up accounts–that’s all standard web stuff and most of the HIXs can’t do it. Those private brokers have both smoothly done this for years and at least the two I mentioned have built comparative tools for the new insurance plans. (Both were demoed at Health 2.0 on October 1).

So why can’t we put prominent links to eHealthInsurance.com and GetInsured on the Healthcare.gov site and move people over there? Continue reading…

My Personal Affordable Care Act–A Manifesto

The Founding Fathers had one.  Karl Marx had one.  Bertrand Russell and Albert Einstein had one.  And, now I have one: a manifesto, declaring my intent to live my life with as little interaction as possible with the US health care system by doing what the Affordable Care Act (ACA) tells me by omission I do not need to do: take responsibility for myself.

This is my Personal Affordable Care Act.

My manifesto is an algorithm for thriving in spite of the government’s naked and absurd attempt to define health as something that begins in the clinic.  My goal is to make myself and my family as scarce as possible within the health care system.

The ACA is a collective solution to the mass failure of individual will.  Our transformation into an information culture actually worsened the malady.  We are so conditioned to success at the speed of a search engine that, like the person who aspires to retire early, but refuses to save, we’ve forgotten to manage the fundamentals.

First, that every healthy lifestyle decision you make today, from diet and exercise to outlook and mood, requires thought and an exertion of will.  Even in the age of Google, volition matters, and choosing not just wisely, but strategically, is an option available to most people.

Second, despite revolutionary democratization of medical information, we still don’t do our homework.  Americans visit physicians 3 times per year on average, and the number one reason for the visits is “cough.”  Really?  You need to go to the doctor for a cough?  Unless you have a fever, chest discomfort, bloody sputum, or the cough lasts for weeks and keeps you up at night, it is almost certainly viral or related to an allergen and self-limited.

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The Federal Shutdown is Over. The Health Care Fight is Just Getting Started. Here’s What May Happen Next…

Social security numbers allegedly passed around in clear sight. Page after page of unworkable code. And no clarity on when it will all be fixed.

Just another day of trying to log in to healthcare.gov.

Two weeks after its launch, the federal health insurance exchange is a “failure,” says the Washington Post‘s Ezra Klein. Some officials deserve to be fired, according to Robert Gibbs, who until February 2011 was one of President Obama’s closest advisers.

And those are the Affordable Care Act’s supporters.

Even the president conceded on Tuesday that healthcare.gov had “way more glitches than I think are acceptable.”

Those glitches could take months — or even years — to fix, according to reports. But there’s a key deadline looming: Jan. 1, 2014, when the ACA’s individual mandate takes effect.

Under the mandate, millions of Americans who were expected to use the exchanges to obtain health insurance will face fines if they haven’t purchased coverage by Feb. 15, raising the question of whether the mandate or other Obamacare provisions should be postponed — an uncomfortable position for an administration already trying to implement a politically divisive law.

But at this late date, what parts of the ACA can legally be delayed?

“In a sense, all of it,” Timothy Jost, a Washington & Lee law professor, told me. But “there’d be a high political price to pay. And delay could result in litigation.”

Jost was among several experts who spoke with me about the health insurance exchanges’ bumpy rollout, the ripple effects for the mandate and other provisions, and what it could all mean for implementing the ACA.

What Agencies Can and Can’t Do
When considering a delay to Obamacare, it’s important to understand the difference between statutory and discretionary deadlines.

For example, the ACA’s language directly calls for many mandatory deadlines — like rolling out the individual mandate or implementing a slew of insurance market reforms on Jan. 1, 2014.

But the agencies also have had considerable leeway on how they’ve chosen to apply the law — like choosing an Oct. 1 launch date for the exchanges, a deadline that retrospectively seems ambitious.

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Knocking on Health 2.0’s Door

I recently attended the flagship Health 2.0 conference for the first time.

To avoid driving in traffic, I commuted via Caltrain, and while commuting, I read Katy Butler’s book “Knocking on Heaven’s Door.”

Brief synopsis: healthy active well-educated older parents, father suddenly suffers serious stroke, goes on to live another six years of progressive decline and dementia, life likely extended by cardiologist putting in pacemaker, spouse and daughter struggle with caregiving and perversities of healthcare system, how can we do better? See original NYT magazine article here.

(Although the book is subtitled “The Path to a Better Way of Death,” it’s definitely not just about dying. It’s about the fuzzy years leading up to dying, which generally don’t feel like a definite end-of-life situation to the families and clinicians involved.)

The contrast between the world in the book — an eloquent description of the health, life, and healthcare struggles that most older adults eventually endure — and the world of Health 2.0’s innovations and solutions was a bit striking.

I found myself walking around the conference, thinking “How would this help a family like the Butlers? How would this help their clinicians better meet their needs?”

The answer, generally, was unclear. At Health 2.0, as at many digital health events, there is a strong bias toward things like wellness, healthy lifestyles, prevention, big data analytics, and making patients the CEOs of their own health.

Oh and, there was also the Nokia XPrize Sensing Challenge, because making biochemical diagnostics cheap, mobile, and available to consumers is not only going to change the world, but according to the XPrize rep I spoke to, it will solve many of the problems I currently have in caring for frail elders and their families.

(In truth it would be nice if I could check certain labs easily during a housecall, and the global health implications are huge. But enabling more biochemical measurements on my aging patients is not super high on my priority list.)

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Chaos and Order: An Update From Patient Privacy Rights

Thanks to the flood of new data expected to enter the health field from all angles–patient sensors, public health requirements in Meaningful Use, records on providers released by the US government, previously suppressed clinical research to be published by pharmaceutical companies–the health field faces a fork in the road, one direction headed toward chaos and the other toward order.

The road toward chaos is forged by the providers’ and insurers’ appetites for categorizing us, marketing to us, and controlling our use of the health care system, abetted by lax regulation. The alternative road is toward a healthy data order where privacy is protected, records contain more reliable information, and research is supported or even initiated by cooperating patients.

This was my main take-away from a day of meetings and a panel held recently by Patient Privacy Rights, a non-profit for whom I have volunteered during the past three years. The organization itself has evolved greatly during that time, tempering much of the negativity in which it began and producing a stream of productive proposals for improving the collection and reuse of health data. One recent contribution consists of measuring and grading how closely technology systems, websites, and applications meet patients’ expectations to control and understand personal health data flows.

With sponsorship by Microsoft at their Innovation and Policy Center in Washington, DC, PPR offered a public panel on privacy–which was attended by 25 guests, a very good turnout for something publicized very modestly–to capitalize on current public discussions about government data collection, and (without taking a stand on what the NSA does) to alert people to the many “little NSAs” trying to get their hands on our personal health data.

It was a privilege and an eye-opener to be part of Friday’s panel, which was moderated by noted privacy expert Daniel Weitzner and included Dr. Deborah Peel (founder of PPR), Dr. Adrian Gropper (CTO of PPR), Latanya Sweeney of Harvard and MIT, journalist Sydney Brownstone of Fast Company, and me. Although this article incorporates much that I heard from the participants, it consists largely of my own opinions and observations.

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Health 2.0 Co-Founders Address How to Adapt to a New World of Health Care and the Problems it Encompasses

Health 2.0 co-founders Matthew Holt and Indu Subaiya gave separate keynote speeches on the second day of Health 2.0’s 7th Annual Conference earlier this month, setting the tone for the remainder of the event.

Holt began by giving an overview of the rapidly changing world of health care and his advice for the viewers in adapting to such changes.  He spoke of the comparatively low use of EMRs, the importance of trackers, and sharing data between consumers and professionals as specific challenging trends.

Watch Matthew’s full keynote here.

CEO Indu Subaiya followed Holt and addressed the “seven deadly sins of health care,” which ranged from too much testing to end of life care.  She compiled this list after an active conversation with eight of her trusted colleagues about the parts of health care which might not be “typically kosher.”  Subaiya shifted perspective from specific negativities to look at the health care system in a new way; shining light on potential ways to improve these problems. Subaiya’s keynote left the room with an optimistic view of real problems in the health care system.

Watch Indu’s full keynote here.

Redefining Health Care with Health 2.0 Bottom-Up Thinking

Santa Clara, CA- Lt. Governor Gavin Newsom urged a crowd of over 2000 health IT entrepreneurs and thought leaders to forge ahead in leading the health care revolution and not to wait on the government in his keynote at the Health 2.0’s  7th Annual Fall Conference this year.

Newsom observed that the innovation happening in health care technology embodies the “bottom-up” thinking that is defining the future of both health care and society in general. “It’s a whole new level of thinking: it’s platform thinking, not machine thinking. The world will be defined by mobile, social, and local trends. It’s not top down. The pyramid has inverted. That’s what Health 2.0 is all about.”

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How Naïve Can Democrats Get?

Beholding David H. Howard’s rendering of the crazy-quilt of financial sources that have been tapped by the designers of the Affordable Care Act of 2010 (hereafter ACA ’10) to finance the new entitlements they put in place – a little nuisance tax here, a little nuisance cut in other federal spending there – reminds me once more of the sincere, indeed touching, naiveté with which Democrats tend to go about enacting new entitlements.

It is a totally counterproductive and inelegant approach. To be sure, none of the added taxes or spending cuts in the bill seriously disrupt anyone; but they do spread a little pain all around. Therefore, it seems almost deliberately designed to maximize opposition to it from many quarters.

It also leads to acute embarrassments, such as having to postpone by a year (and perhaps more years) the unseemly penalty imposed on employers with 50 or more employees each working 40 your or more etc etc, even at the appearance of having broken the law – or so we are told.

When will the Democrats ever learn?

And from whom might they learn?

From the Republicans, of course.

Dream back to the good old days – 2003 – when the Bush Administration and the Republican Congress pushed through, with deft parliamentary maneuvering and some arms twisting, H.R. 1 (2003), the Medicare Prescription Drug, Improvement, and Modernization Act – hereafter the MMA ’03.

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