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The Law Always Lags Technology: Implications for Digital Medicine

Three recent developments have highlighted how difficult it is to predict when and if disruptive technologies will transform clinical medicine in the United States. That we are undergoing an avalanche of new information and new technology is hardly newsworthy. From the dawn of civilization to 2003, human beings created 1 billion gigabytes of new information. In 2012, Google says they catalog 2 billion gigabytes of information every two days.

One of the confounding factors on how this new knowledge and technology is adopted by an industry like health care is the law. Henry Perritt, Jr. describes two ways to think about the relationship between the law and technology. Technological change is “a major source of human problems that the law must address.” The law also always lags technology because the common law tradition requires “that the legal system should not predetermine the course of technological application and product development.” http://jolt.law.harvard.edu/articles/pdf/v10/10HarvJLTech689.pdf

The first example of this concept of the law lagging technology involves American citizen Ellie Lavi who underwent in vitro fertilization and the subsequent birth of twins in Israel. When she went to the American Embassy, she was told that her children would not be American citizens unless she could prove that either the egg or sperm used in her case came from an American citizen. “The problem is that the law hasn’t kept up with the advances in reproductive technology,” states Lawyer Melissa Brissman. http://www.usatoday.com/news/world/story/2012-03-19/in-vitro-citizenship/53656616/1

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Beyond Coding: Will the ICD-10 Deadline Delay Help or Harm?

At HIMSS, I met with many healthcare CIOs as a part of CHIME focus groups to discuss their readiness for ICD-10. One area we explored was the impact of the delay. Most were a bit frustrated by the delay because they had committed the resources and money to an ICD-10 transition plan which was well underway. In some instances CIOs estimated they had expended at least 50 percent of the effort required to meet the compliance deadline. In fact, in one of the focus groups, 10 out of 12 participating CIOs said the delay will be more harmful than helpful. I heard two main reasons for this position:

1. Cost: Hospitals have already committed the resources and budget to transition to ICD-10, and now they will have to continue that effort for a longer period of time.

2. Engagement: It’s harder to engage staff around the importance of clinical documentation and coder education when the media is saying “delay, delay, delay” – it makes it difficult for leaders to convince providers and other stakeholders that it’s a critical priority.

A survey conducted by Edifecs validates this sentiment – 90 percent of healthcare professionals believe that the deadline should not be moved more than a year. Fifty-six percent said that a two-year delay would be “potentially catastrophic.”

However, for smaller physician practices, the delay likely has the opposite impact – more help than harm. Many of these practices were struggling to understand the impact of ICD-10 and find the resources to prepare for the October 2013 deadline. A delay gives them more time to put a plan in place, improve clinical documentation, and ensure they can get reimbursed for services.

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Why Are Primary Docs Thinking About Leaving Medicine?

As you can imagine, I spend a lot of time with physicians. As a group, they sure do like to complain. Yet, medical school applications are strong, and residency spots are still competitive. So I take cries of “they’re all going to quit” with a grain of salt.

That said, I also like data. So it’s worth checking in every once in a while to see what physicians, as a group, are thinking. There’s a study in the Journal of Primary Care and Community Health that does just that:

The status of the primary care workforce is a major health policy concern. It is affected not only by the specialty choices of young physicians but also by decisions of physicians to leave their practices. This study examines factors that may contribute to such decisions. We analyzed data from a 2009 Commonwealth Fund mail survey of American physicians in internal medicine, family or general practice, or pediatrics to examine characteristics associated with their plans to retire or leave their practice for other reasons in the next 5 years.

What did they find? More than half of physicians age 50 and over had plans to leave their practice in the next 5 years, or weren’t sure about staying in practice. No physicians age 35-49 had plans to retire, but 20% weren’t sure they’d stay in practice. I take such numbers with a grain of salt, though. That’s partly because, as I said above, doctors like to complain. That’s also because saying what you are going to do in the future is not the same as what you will actually do. In case people hadn’t noticed, the job market isn’t too awesome out there. I think many physicians are delusional if they think they can just quit practicing medicine and find another lucrative job.

But I think that the reasons that primary care docs say they might quit are illuminating. Those reasons are likely the things that make them unhappy about practicing, and we can definitely learn from that.

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Healthy Competition

While there are important differences between the NHS and the US health system, both face similar challenges in improving productivity and disrupting the traditional model of healthcare that is no longer fit for purpose. Both are facing rising demands of an ageing population, increasing prevalence of chronic conditions and consumer expectations. Both systems have powerful incumbent providers such as general hospitals that are not always responsive to changing patient and system needs. As Elizbaeth Tesiberg and many others of both sides of the Atlantic have argued, “innovation is the only long-term solution to high-quality, affordable health care.”

Leading pioneers from around the world are already transforming healthcare. In its recent report, Healthy competition, the London based think tank Reform, highlighted a number of case studies of successful change. Reform explored four crucial areas that can improve productivity in healthcare: service reconfiguration, integrating care, standardisation of processes and procedures, and measuring and publishing outcomes.

Greater patient safety through service reconfiguration

Successful reconfiguration has achieved higher quality and greater value for money. In Finland, the Pirkanmaa region closed joint replacement departments in five hospitals and concentrated care at one specialist hospital.  The new hospital delivered complication rates below 1 per cent compared to an average of up to 12 per cent for general hospitals. The NHS in London moved emergency stroke care from 34 general hospitals to eight specialist units with dedicated staff. London now has the highest standards of stroke care of any major international city.

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In Defense of Paul Ryan’s Budget Plan

I once called an older version of Paul Ryan’s budget plan “voodoo economics.” But you have to admire him. He has just released a new plan that slashes the deficit from 8 percent of GDP to around 1 percent by the end of the decade while simultaneously keeping revenues at 18 percent of GDP over the decade, very close to their historical average. To be sure, the specific policies required to get there are not well specified and there is much that I don’t like, such as the assumption that we don’t need new revenues to close the fiscal gap; still, after reading the “Path to Prosperity” I came away with a sense that there is food for thought, worthy of further discussion and debate, in this document.

I came to this conclusion after reading the section of the document called “repairing the safety net.” I had figured out that a lot of the savings in this plan had to come from slashing programs for the poor so I expected to be horrified by what I read. I am not in favor of cutting programs for the poor, especially in a plan that reduces taxes for the wealthy and leaves Social Security virtually untouched. Instead, I found myself at least intrigued with the arguments that I found in this section of the plan. They are thoughtful, well-articulated, and worthy of further debate.

One argument is that federal subsidies for safety net programs encourage states to spend more than they otherwise would. Another argument is that federal dollars come with federal prescriptions and paperwork that stifle state innovation and efficiency. A third argument is that these programs undermine efforts by civic or faith-based groups to play a stronger role. A fourth argument is that some of these subsidies (for example, Pell grants) simply bid up prices (for college tuition). A fifth argument is that we have too many overlapping and complex programs with similar purposes (job training being a great example). A sixth argument is that assistance should be made conditional on personal responsibility—for example, being engaged in work or job training if you are receiving government assistance. This model of conditional assistance was a key element in the largely successful 1996 welfare reform law and could be expanded to other programs. Finally, the plan emphasizes the importance of upward mobility—a goal which I think many can embrace.

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The Return of the Ryan Plan

In announcing the Republicans’ new budget and tax plan Tuesday, House Budget Committee Chairman Paul Ryan said “We are sharpening the contrast between the path that we’re proposing and the path of debt and decline the president has placed us upon.”

Ryan is right about sharpening the contrast. But the plan doesn’t do much to reduce the debt. Even by its own estimate the deficit would drop to $166 billion in 2018 and then begin growing again.

The real contrast is over what the plan does for the rich and what it does to everyone else. It reduces the top individual and corporate tax rates to 25 percent. This would give the wealthiest Americans an average tax cut of at least $150,000 a year.

The money would come out of programs for the elderly, lower-middle families, and the poor.

Seniors would get subsidies to buy private health insurance or Medicare – but the subsidies would be capped. So as medical costs increased, seniors would fall further and further behind.

Other cuts would come out of food stamps, Pell grants to offset the college tuition of kids from poor families, and scores of other programs that now help middle-income and the poor.

The plan also calls for repealing Obama’s health-care overhaul, thereby eliminating healthcare for 30 million Americans and allowing insurers to discriminate against (and drop from coverage) people with pre-existing conditions.

The plan would carve an additional $19 billion out of next year’s “discretionary” spending over and above what Democrats agreed to last year. Needless to say, discretionary spending includes most of programs for lower-income families.

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Rejecting Affordable Care Act Is Rejecting Constitution

Next week, while the Republicans continue their search for a candidate to stand against President Obama in the fall election, the president’s central legislative triumph – the Patient Protection and Affordable Care Act of 2010 – will come before the Supreme Court. The justices have the power to declare the law unconstitutional and thereby kill “Obamacare” before it even leaves the birthing chamber. While some believe that such an outcome would be proper, we disagree. A court decision overturning the Affordable Care Act would be an egregious misreading of the Constitution.

The critics’ central constitutional claim is that the 2010 law’s individual-mandate provision exceeds Congress’ regulatory authority. In essence, this provision requires a broad swath of Americans to procure health insurance conforming to certain federal standards. Those who do not procure this insurance must generally pay a “penalty” to the IRS.

Had the bill explicitly used the word “tax” instead of “penalty,” the fatal flaw of the constitutional challenge would be obvious to all. The Constitution undeniably gives Congress sweeping power to tax. And if Congress can tax a person, and then use that tax money to buy a health-care package for that person’s benefit, why can’t it simply direct the person to procure the package himself, or else pay a higher tax?

Of course, tax is a word that lawmakers try to avoid at all costs, and so the euphemistic penalty won the day. Yet, as Shakespeare reminds us, “a rose by any other name would smell as sweet.” Here, penalty and tax are simply two ways of saying the same thing.

Indeed, the Constitution itself does not always use the T-word when referring to taxes, broadly defined. It also uses the words excises, duties, and imposts in the opening sentence of Article I, Section 8, and elsewhere refers generally to all generic “Bills for raising Revenue.” The important thing here is not the term, but how the actual instrument functions, and clearly Obamacare functions as a tax – as a revenue measure. In perfect synch with the Constitution’s key word, revenue, the penalty section of Obamacare is in fact codified in title 26 – the Internal Revenue Code. The “penalty” is paid to the IRS via forms administered by that very same IRS.

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Government Cannot Regulate Beliefs

Can religious beliefs be forced on you? Can government decide which religious beliefs are “acceptable” and which are not? Of course not. But this is the crux of the “free exercise” debate ignited by the Obama administration’s recent new health care mandate that forces employers to provide “free” contraception, sterilization and abortifacients.

The issue is not one of good health — despite election-year efforts to frame it as such. If it were only about good health, government would have long ago outlawed smoking, mandated daily vitamins and forced employers to provide gym memberships. The issue is not even “free” contraception. If it were, a member of Congress with an elastic view of the Commerce Clause would have long ago introduced a bill providing it to the public for “free” — whatever that means.

The real issues are whether the First Amendment is broad enough to include beliefs with which we disagree, and whether government can tacitly or otherwise force us to abandon our religious beliefs simply because something constitutes sound public policy.

A debate over sound public policy never can be substituted for constitutional consistency. If government action affects religious liberty, the government must (1) provide a compelling reason for the encroachment on free exercise and (2) prove the action used is the least restrictive means available.

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Why Should We Cover People Who Don’t Take Care of Themselves?

One of the most common ideas in the whole healthcare financing discussion is a moral one. Why, people say, should my taxes and my healthcare premiums go to take care of the huge medical problems of people who don’t take care of themselves? As one commenter on THCB put it: “…self inflicted injuries to not be covered at all, ideally. If someone drinks their liver away I don’t think we should all have to buy them a new one. Same for smoking.”

This is a common idea, one that seems logical and right on the surface. But there are four assumptions built into it, all four of which have problems:

1) That the “self-inflicted injuries” that people commonly identify (smoking, drinking, other addictions, obesity) actually are major predictors of cost.
2) That we can clearly differentiate “self-inflicted injuries” from other medical problems
3) That to the extent that they are actually “self-inflicted,” the patient could just stop doing them if they just had enough gumption, or enough something.
4) That if our goal is to cut unnecessary medical costs, refusing medical coverage would cut costs.

But each of these four is problematic.
1) The best predictors of medical costs are not smoking, drinking, or obesity, but depression and stress. (“Association Between Health Risks and Medical Expenditures“) So trying to dis-insure “self-inflicted injuries” might miss the target of lowering healthcare costs.

2) Trying to decide what is “self-inflicted” and what is not presents a major problem. A friend has a lifelong condition that gives him excruciating pain. He has struggled manfully (and successfully) against addiction to booze and painkillers to ameliorate his pain. He has always felt bitter toward his father because his father was addicted to booze and painkillers. He recently realized that his condition is genetic, and guessing from some symptoms he observed, realized that his father was fighting the same excruciating pain. His attitude toward his late father changed instantly.

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Health Insurance Exchange Regulations and the Health Reform Challenge

I had the opportunity to hear Pennsylvania Insurance Commissioner Michael Consedine speak in Philadelphia about his state’s progress towards building an exchange the very next day (I was speaking later on the program). Pennsylvania is one of the 26 states challenging the federal health reform law (and even has a state constitutional amendment afoot that would bar implementation of the individual mandate in PA), but that hasn’t stopped the Keystone State from spending a $1 million planning grant and getting a $33.8 million implementation grant to kick their state health insurance exchange into high gear. (Nothing like playing both sides, eh?)

Now that the regs are final, Pennsylvania and the rest of the states had better get cracking, because they are all supposed to have functioning exchanges by January 1, 2014.  The next step would for the federales to give the high sign that they are on track by January 1, 2013 by confirming that they meet the requirements of the “Exchange Blueprint” (which seems less prescriptive than “Plan”); if they don’t, or Uncle Sam says their plans aren’t up to snuff, then the feds are to step in and run the state exchange. Interestingly, state-level exchanges may be run by the feds (i.e., HHS) “directly or through agreement with a not-for-profit entity.” 45 CFR 155.105(f).

While some detail is offered about state-chartered not-for-profits that may run exchanges on behalf of states, regions within states, or groups of states (though given current insurance marketing rules and practices that are state-specific, multistate exchanges seem yet to be a pipe dream), no detail is offered about this potentially very important not-for-profit — after all, there could theoretically be a single not-for-profit entity operating most state-level exchanges come January 2014.  Furthermore, a state-run exchange may contract out its operations in whole or in part to a private entity “that has demonstrated experience on a State or regional basis in the individual and small group health insurance markets and in benefits coverage” and is not a health insurance issuer. 45 CFR 155.110.  It will be interesting to see which of the usual suspects move into this new market opportunity.

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