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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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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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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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Should We Sacrifice Medicine’s Sacred COW?

Chicago Cubs fans of a certain vintage will never forget broadcaster Harry Carey’s signature line, “Holy cow!”  Some have speculated that the exclamation may have originated in Hinduism, one of the world’s major religions, whose adherents worldwide number approximately one billion.  Hindus regard cows as maternal, caring figures, symbols of selfless giving in the form of milk, curds, butter, and other important products.

One of the most important figures in the faith, Krishna, is said to have been a cowherd, and one of his names, Govinda, means protector of cows.  In short, cows are sacred to Hindus, and their slaughter is banned in virtually all Indian states.

Medicine, too, has its sacred cows, which are well known to physicians, nurses, and patients visited by medical teams on their hospital rounds.  In this case, the cow is not an animal but a machine.  In particular, it is the computer on wheels, or COW, a contraption that usually consists of a laptop computer mounted on a height-adjustable pole with a rolling base.  It is used to enter, store and retrieve medical information, including patients’ diagnoses, vital signs, medications, and laboratory results, as well as to record new orders.

As the team moves from room to room and floor to floor, the COW is pushed right along. The COW is often treated with a degree of deference seemingly bordering on reverence.  For one thing, people in hallways and patients’ rooms are constantly making way for the COW.  As an expensive and essential piece of equipment, it is handled gingerly.  Often only the senior member of the medical team or his or her lieutenant touches the COW.

Others know that they have said something important when they see the chief keyboarding the information into the COW.  Sometimes it plays an almost oracular role. When questions arise to which no one knows the answer, such as the date of a patient’s admission or the time course of a fever, they often consult the COW. Just as cows wandering the streets of Indian cities often obstruct traffic, so healthcare’s COWS can and often do get in the way of good medicine. Continue reading…

When Talking About the Exchanges, It’s Probably a Good Idea to Look Beyond Opening Week Returns

It was an up and down week for supporters of the Affordable Care Act. Republicans appear to have stopped linking government funding with partial repeal of the ACA. And well-publicized software problems plagued the 36 federally managed exchanges, making it difficult for enrollees to complete the application process. Still, supporters could crow about the large number of insurers who are offering products and the millions of Americans who visited the online exchange enrollment sites as a clear sign of the success of the Affordable Care Act.

We should never confuse activity with accomplishment.

A few software updates will not be sufficient to assure the success of the exchanges. Two more important things must happen: Visits to web sites must translate into enrollments, and enrollees must represent the kind of cross-section of risks that will keep insurers in the exchanges in years to come.

Not surprisingly, enrollment figures vary considerably by state, with some states operating their own exchanges reporting some of the highest enrollments to date. But upon even minimal inspection, current enrollments leave much to be desired. In New York, 40,000 individuals completed applications in the first week, not bad until you consider that several million state residents are eligible for insurance.

Washington State has 1 million eligible residents and just over 10,000 applicants. Reporting that 29,000 California residents had completed their enrollment applications, exchange Executive Director Peter Lee stated that this “blew his socks off.”

Let’s put this in perspective.

With 7.1 million uninsured in California, an application pool of 29,000 shouldn’t knock any garments off of anyone!

These are the “success” stories. At the other end of the spectrum, at last count Maryland had a whopping 566 applicants. And lest we forget, applications are not the same thing as enrollments. Some insurers have claimed that applications are incomplete – potentially leading to a troubling situation where uninsured individuals may incorrectly think that they have secured insurance.

Before patting themselves on the back, exchange supporters should stand back and see what happens. Coming from the nation’s entertainment capital, California’s Mr. Lee should be especially aware of the dangers of judging success from opening week returns. Will the exchanges be like The Lone Ranger, which topped the box office in its opening week and then quickly faded away? Or will they be more like Argo, which gradually built its audience over time? Time will tell.

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Of Course, Then There’s The Fact That You May Be Better Off Waiting To Buy Coverage, Anyway …

Will all the White House messages, the stream of breathless Twitter updates on the number of hits and enrollments, and the press hype surrounding opening day send the uninsured public into panic mode? Will they prompt buyers to consider only the premium and click to enroll ASAP? And why not? For weeks the administration, state exchange officials and supporters of the Affordable Care Act have been telling the public how cheap premiums will be — much cheaper than expected.

A Pennsylvania woman told me she was chomping at the bit to enroll because she was eager to dump her policy from Aetna for a cheaper model from Blue Cross. Never mind that she had no idea whether the coverage was better, the same, or worse.

A Nebraska woman heard there was a worksheet to fill out and it had to be completed by October 1. It was first-come-first-served, an agent had told her.

If cheap premiums were the only thing shoppers had to consider, this sense of urgency might be fine. But it’s not. Here’s the problem.

Selecting a health insurance policy is fraught with potential missteps and misunderstandings. As the Nebraska woman told me, “You’re walking into a chasm of uncertainty. It’s like shopping for a used car. You don’t know if you’re getting a lemon,” a lemon you’re stuck with until the next open enrollment.

For consumers, the key advice right now is: don’t rush into anything. Tuesday, October 1st marked the first day of a six-month open enrollment period, not the last. Coverage doesn’t even begin until January 1, 2014, so there’s no need to buy the first policy you see. If you do want coverage on January 1, the deadline for enrolling is Dec 15.

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