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The 2016 Regulatory Landscape: A Review For Health Care Watchers

The healthcare industry in the U.S. is highly-regulated at the state and federal levels, and the balance between the two depends on what part of the industry you’re in. To illustrate—

  • Health insurers are overseen by state insurance regulators, but the Affordable Care Act added a new layer of federal oversight. The current tussle between HHS and the National Association of Insurance Commissioners over what constitutes an accessible network of providers is a case in point.
  • The 56,000 retail pharmacies are overseen by states, but drug manufacturers and distributors are overseen by the FDA and FTC, and the 3000 compounding pharmacies find themselves regulated by both.
  • Physicians are primarily self-regulated by their state licensing and disciplinary boards, but federal rules that require transparency (Physician Sunshine Act) about their performance and prescribe limitations in their business dealings (Stark rules) take precedent.

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The Year of the Hacker

flying cadeucii2015 was the year health care got serious about cyber security.

Hackers gave the industry no other choice.

The year started with a massive data breach at Indianapolis-based Anthem Inc., which the health insurer revealed on Feb. 4. Hackers roamed around in Anthem’s computers for six weeks and stole personal and financial information of 78.8 million customers, as well as the information of 8.8 million customers at Blue Cross and Blue Shield plans not owned by Anthem.

There have been 269 data breaches at health care organizations this year, according to statistics collected through Dec. 22 by the Identity Theft Resource Center. That’s actually down from 2014, when health care organizations suffered 333 breaches.

But the number of records stolen has soared to 121.6 million records stolen, up from less than 8.4 million records in 2014. Even without the Anthem breach, there were still 34 million records stolen this year from health organizations.
The health care industry accounted for one out of every three breaches recorded by the Identity Theft Resource Center.

“They can and are trying to break into everything,” Doug Leonard, president of the Indiana Hospital Association, said of hackers. He added, “It’s really on everybody’s radar screen in the health care industry.”

In a survey released in August by consulting firm KPMG, 81 percent of health care executives said their organization had suffered a cyber attack in the previous two years and 13 percent said they were being attacked daily.

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Why Meaningful Use Has to Go

flying cadeuciiWe don’t win anymore in health care. After repeatedly drilling in our heads that America’s sick care system is a disaster, that those who care for the sick are incompetent and stupid, and that the sick themselves are losers, Meaningful Use was advertised as the means by which technology will make health care great again. The program has been in place for 5 years and the great promise of Meaningful Use is just around the same corner it was back in 2011. The only measurable changes from the pre Meaningful Use era are the billions of dollars subtracted from our treasury and the minutes subtracted from our time with our doctors, balanced only by the expenses added to our medical bills and the misery added to physicians’ professional lives.

Meaningful Use, a metastasizing web of mandates, regulations, exclusions, incentives and penalties, is conveniently defined in the abstract as a set of indisputably wholesome aspirational goals for EHR software and its users, which stands in stark contrast to the barrage of bad news flooding every health related publication, every single day. Health care in America used to be the best in the world, but now our health care is crippled. Meaningful Use of EHR technology will improve quality, safety, efficiency, care coordination, and public and population health. It will engage patients and families, and it will ensure privacy and security for personal health information. With Meaningful Use leading the way, health care will be winning so much that your head will be spinning. You won’t believe how much we’ll be winning.

Be afraid, be very afraid

Bombastic? Laughable? Easily dismissible by educated people? Not so fast. According to Dr. David Blumenthal, president of the Commonwealth Fund, and former National Coordinator for Health IT, “we probably have the worst primary care system in the world”. Yes, worst system in the whole wide world, worse than Niger, Malawi and Somalia. Probably. According to a hobbyist “study” that extrapolates its “results” from a handful of other studies based on an admittedly inaccurate tool intended for different purposes, 440,000 people are killed in hospitals due to preventable errors each year – “that’s the equivalent of nearly 10 jumbo jets crashing every week”. Or, with a little more math, half of all hospital deaths, and one in six US deaths, are due to negligent homicide perpetrated by psychopathic doctors and nurses.

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The Quest For Zero Infections: A Fool’s Mission?

flying cadeuciiJoyce is sick.  I am in the intensive care unit, peering at vital parameters that glow on the screen above her bed.  My eyes linger on those numbers because it is easier than looking at her.  A fever rages, her core temperature reads 103.4 degrees.  Her white hair is plastered on her forehead with sweat, and a tube to help her breathe emerges from her mouth and heads to a ventilator that angrily tweets a musical alarm every few minutes.  Her breathing is painfully obvious.  Her stomach moves paradoxically inward on every breath, and I can see the muscles in her neck tense with the effort of every breath.  Mercifully, her eyes are closed.  A nurse walks in and starts to change a bag of fluids that is hanging by her bed.  I follow the flexible plastic tubing that arises from the bag to an infusion pump, and then to a catheter that snakes under a see-through dressing underneath Joyce’s left collarbone.  I ask the nurse about how long the catheter has been in place…’3 days’…I’m told.  I mutter about the possibility of a central line infection – the dreaded central line-associated blood stream infection (CLABSI).  The nurse shakes her head, and tells me – “we don’t get those anymore”.

CLABSIs are ground zero in the war on preventing patient harm.  The story entered the mainstream consciousness in the lyrical words of Atul Gawande in the New Yorker in 2007.  There he told a story of an unlikely Superman in the form of a critical care intensivist named Peter Pronovost. Dr. Pronovost was waging war against infections from these nefarious central lines that were saving and killing patients at the same time.  He published a landmark study in the New England Journal of Medicine that used an evidence-based intervention to dramatically reduce infection rates in the intensive care unit.  Some form of the implementation bundle that worked for Dr. Pronovost soon found itself in ICUs everywhere.  Dramatic reductions in CLABSI rates followed.

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Thirty Events That Really Did Very Little to Change Health Care’s World

Paul Levy 1It was with some dismay that I read Modern Healthcare’s article called, “The 30 events that rocked healthcare’s world in 2015.” I jumped into the piece, confident that I would, indeed, find some developments that have made a difference in the quality and safety of patient care, that would introduce transparency, and that would encourage a greater partnership between clinicians and patients and families.

What I found instead was a version of The Nightly Business Report–a series of stories mainly about the corporate and financial interests of pharma, insurance companies, big hospitals, and big government. These stories have nothing to do with what actually happens on the floors and units of America’s hospitals or in the offices of local physician practices. There is nothing in the stories that is motivational to the doctors, nurses, and other health care professionals who have devoted their lives to taking care of us. There is nothing in the stories that presents an empathetic view of what happens to us when we interact with the health care system as patients or families.

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This Year Give The Gift of the Health Care System

Screen Shot 2015-12-26 at 5.36.34 AMThe United States health care system is a big, expensive mess, and the people working in the system today often don’t even know how to start learning about the system, and it’s problems.  My own frustration with the health care system – and lack of teaching about it during medical school – lead me to write The Health Care Handbook: A Clear and Concise Guide to the US Health Care System with my colleague Elisabeth Askin.  The goal was to create an understandable primer on the health care system for providers so that we can all work together to improve the system and help our patients.

We have partnered with THCB to provide excerpts from the 2nd edition of the Handbook, which will provide background and insight on important health care issues that we face today.  We would love your questions, comments and feedback.  Today’s excerpt provides a brief overview of the state of the US health care system today.

Cost 

The U.S. currently spends more than 17% of its national gross domestic product (GDP) on health care, far more than any other country in the world. Health care spending now averages almost $9,000 per American,1and health care is the fastest growing industry in the country.2Private (nongovernmental)health care spending accounts for a large portion of the difference between spending in the U.S. and in other industrialized countries.

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Img2Organisation for Economic Co-operation and Development, “Health Statistics2013,” June 2013. Note: Values in U.S. $ Purchasing Power Parity. Data for Japan and Australia refers to 2008.

Access

The U.S. has fewer physicians,hospital beds, physician visits,and hospitalizations per capita than most other industrialized countries.3 Eighty-five percent of Americans report having a regular source of ongoing care, but more than a quarter encounter difficulty accessing the healthcare system.4 There are large disparities in access by type of health insurance coverage.

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Was Martin Shkreli Arrested For Hiking Drug Prices?

Martin Shkreli

I don’t subscribe to conspiracy theories. I never believed a second shot was fired. Nor do I believe that Bill Clinton was stalked on the grassy knoll. So I won’t speculate that Martin Shkreli’s arrest for alleged securities fraud that happened years ago is related to his raising Daraprim’s price by 5500 %.

Just because something isn’t suspicious doesn’t mean that it isn’t odd.

Shkreli is a perfect poster child for rapacious pharmacocapitalism – so perfect that it’s odd. He openly admits “I have a sworn duty to my shareholders to maximize profit.” Shkreli’s admission is odd not for its implausibility, but brazen honesty.

Who, in the business of making money, says they’re in the business for profit?

Elizabeth Holmes wants to change the world, including Africa, by biotechnology, and she has recruited Henry Kissinger, known for his contributions to emerging economies and biotechnology, to help. Even Goldman Sachs believe their work leads to greater good. Their CEO once said banking is “doing God’s work.” I developed a Richter’s hernia reading that.

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The Little Agency That Could

Leah-BinderIn the children’s book The Little Engine That Could, a little blue engine hauls an improbably large trainload of toys and candy over a mountain while chanting, “I think I can, I think I can, I think I can.” The Labor Department named this classic among the 100 books that shaped work in America.

There’s a federal health agency in Washington that might be called the “Little Agency That Could”: the Agency for Healthcare Research and Quality (acronym “AHRQ”, pronounced “Arc”) – and it’s shaping the work of healthcare in America.

AHRQ’s priority is making the work done in healthcare benefit the patient. They assemble all the treatments, medicines, expertise, technology and medical advances, and figure out the best strategies for delivering them safely and effectively. This is very complex, and lapses and errors in delivery can and do cause unnecessary patient death and suffering on a grand scale. Avoidable errors in hospitals kill upwards of 500 people a day, making it equivalent to the third leading cause of death in the United States.

What works for the patient often defies conventional wisdom, which AHRQ has observed time and again. For instance:

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Job–Health 2.0 seeks Conference Director

Quick note from Matthew Holt, TCHB publisher

Our sister organization Health 2.0 is looking for a conference director. That is, someone to essentially be the GM of our conference business, reporting to me & Indu subaiya. We looking for someone who knows the world of new SMAC technologies in health care (go ahead, Google it!) & who can run an events business. If that’s you or someone you know, please take a look at this job description and apply there.

This Visit May Be Recorded

flying cadeuciiIn their 1993 book, Reinventing Government, David Osborne and Ted Gaebler entitled a section “what gets measured gets done.” Unfortunately, when it comes to improving health care quality, safety, and costs, we often fail to observe the real work of care, and miss the chance to get it done better. To make a real difference, we need to begin measuring care when and where it happens – behind the curtain.

Why We Must Directly Observe Patient Care

For the last 10 years, our work in research and quality improvement has used concealed audiorecorders to capture what actually happens during patient-physician encounters, and to provide feedback to physicians about their performance. Much of our focus has been on demonstrating the importance of appreciating the patient’s life context and showing how encounters in which physicians elicit patient context and incorporate it into care planning have better health care outcomes and lower costs from inappropriate care. We’ve found such contextual factors are relevant to health care in two-thirds of encounters, that physicians ask about them less than a third of the time, and when they are discovered, they are incorporated into the plan less than 60% of the time. Contextual errors—inappropriate care due to failure to contextualize—are pervasive.

Records Don’t Record

Only direct observation of care reveals these errors. The medical record, currently the source of most data in performance improvement, does not and cannot identify mistakes that the physician doesn’t already recognize. The medical record, at best, shows that the physician rendered the care they believe the patient needed, which can be the “right” care for the wrong patient.

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