Fixing Health Care

CMS Should Not Expand their Never-Event List

The CMS should not continue to expand their never-pay list lest they be accused of practicing Medicine.
It makes sense to say that if somebody has the wrong leg amputated, they should not get paid.  That is a big “oops” that every member of the healthcare team should prevent.   But once the CMS crosses over to problems that are questionably preventable, they risk causing more harm than good.

For example: a patient developing a blood clot after surgery.  The cause of this is complex and not fully understood.  In fact, the entire conceptual framework behind how blood clots form in the human body is currently undergoing a massive shift.   Science may just show that the combination of a big surgery plus somebody’s genetic predisposition may reliably lead to the formation of blood clots. 

Why does this matter?  Blood clots are still bad.  The answer is that this type of incentive creates a terrible moral hazard.

If you are not going to get paid for something you have no control over, are you going to admit it is even there?

Here is what CMS announced on July 31st:

In last year’s final rule, CMS listed eight preventable conditions for which it would not make additional payments.  In this year’s proposed rule, CMS identified nine potential categories of conditions, but based on public comments, is finalizing three of these.  The new additional conditions in this year’s final rule include:

·         Surgical site infections following certain elective procedures, including certain orthopedic surgeries, and bariatric surgery for obesity

·         Certain manifestations of poor control of blood sugar levels

·         Deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures

Good job, CMS, on putting your foot down on the craziness of wrong-site surgeries or giving the wrong blood to a patient. 

But do not make the mistake of thinking you save the world through such mechanisms.   In fact, the worse thing that can happen is that we don’t diagnose blood clots, infections, or abnormal glucose levels.  Ignoring these conditions has definitely been shown to lead to bad outcomes.

When the Faith is Gone

Everyone is agreement that the healthcare system is in shambles.  Interestingly, despite lack of satisfaction with the hospital and clinic visit experiences, most people in the U.S. still trust that physicians are doing what is right for them and their families.  That trust is important for many reasons.   One reason that trust is important is that it may be the only thing propping up our current system.  And if that were to go, well, the health care system would likely implode.

But it looks like that might be happening. 

Measles was declared eradicated in 2000 after what was touted as a successful vaccination program.  Vaccinations are advocated for all children, and this stance is endorsed by the Academy of Pediatrics.  However, over the last several years, there has been a rise in the incidence of autism.  Some believe that mercury in the vaccinations led to the development of autism in their children.  As a consequence, there has been reluctance by some parents to have their children vaccinated against measles. 

During this time, there has also been an increase in the incidence of measles. In May 2008, the CDC issued a report on Measles.  They reported that during 2000--2007, 29 to116 measles cases (mean: 62, median: 56) were reported annually. However, during January 1--April 25, 2008, a total of 64 confirmed measles cases were preliminarily reported to CDC, the most reported by this date for any year since 2001.  Sixty -three were not vaccinated.  Clearly, there is a growing concern that the medical profession is causing harm rather than good.

Public concern has continued to deepen.  Last Friday, CBC reported that the vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters.

I do not raise this issue to discuss the merits of the accusations made by CBC.  Instead, I bring it up as an example of failing trust in the medical profession. 

Whether or not this is true, I believe this to be symbolic and a first sign of a significant crack in the trust that has been provided to health care professionals. There are a significant number of parents who are saying that physicians are not always good and, hey, may not even be ethical.   

Many people may see this as a singular example that is not relevant.  I disagree.  Until recently, all of those interested in reforming healthcare have granted physicians a certain respect.  In fact, there are many who believe that physicians are impediments to significant healthcare change, but that they must be accommodated because they are ultimately to be trusted.  When that confidence is shaken, that latitude will likely no longer be granted. 

Regulating Our Intake

In response to the mounting evidence demonstrating the negative health effects of trans-fats, Governor Arnold Schwarzenegger signed a bill banning the use of trans-fats in California over the next few years. 

While nobody will argue that trans-fats are bad and that the elimination of them from our diets would not be missed, I do not think we should raise a toast and commend it as a worthy step towards a healthy America.  Do not get me wrong.  I agree that large amounts of trans-fats have no place as a food group in our diet.  I am not even opposed to banning them.  I am just worried that the excitement and promises of improved health detracts from the real reason why Americans are obese and unhealthy:  we eat a lot (emphasize a lot) of bad stuff and do not exercise.

The addition of trans-fats to our diets occurred in part as a response to America’s eating habits.  The AHA website has a FAQ page about trans-fats.  On that site, they state that trans-fats can be found in many foods,

...but especially in fried foods like French fries and doughnuts, and baked goods including pastries, piza dough, cookies, crackers, and stick margarines and shortenings.

What strikes me is that these “foods” are not the basis for a healthy, diverse diet.  This list is a poster child for bad foods.

America’s appetite for unhealthy foods drove the need for food industry to make those foods available and cheap.   In fact, there may be other evils lurking out there that we have not even identified.  Margarine was touted as healthier than butter for decades—trans-fats did not get attention until the 1990’s.  What else on the ingredient list of our favorite packaged snacks is the next killer? 

National Health Care Priorities and Progress

As electronic medical records receive growing amounts of attention, so do its byproducts.  On byproduct of electronic data is Bioinformatics.  Bioinformatics, or just Informatics, are evolving terms.  In general these terms refer to the leveraging of computer technologies to improve delivery and analysis of health care data.

From the provider and vendor side, one area of interest in informatics has been the development of computer-based decision support systems.  As we discuss quality and improvements in health care, exploration of new applications such as these are absolutely critical to achieving the goal of better quality health care.

However, there is a potential difficulty as we attempt to grow and improve.  That difficulty is potentially-cumbersome government regulation. 

While at the American Medical Informatics Association Summit on Translational Bioinformatics in March of this year, I listened to an interesting panel discussion.  The panel was designed to discuss regulatory issues associated with clinical support tools.  I learned that the FDA is watching the development of this area closely.  Currently, they consider computer-based decision support systems to be “medical devices” which means that computer programs such as these fall under their watch.  Therefore, before use in the clinical realm, FDA approval is required.  This means that nobody in his or her right mind who knows this will want to go through an FDA-approval process.  Therefore this area will not develop.  Luckily, not many people are aware of this regulation.

I was reminded of this fact after seeing another complication of government regulation on a post on the Commonwealth Fund website. 

Vida Foubister wrote an article summarizing the drama surrounding the initial shut-down (and later re-opening) of a Michigan quality improvement project. The Michigan project was an amazing initiative that won widespread praise in the Medical community.  With their initiative, they were able to reduce the number of life-threatening catheter-related bloodstream infections in over 100 intensive care units. Most ICUs are now trying to mimic their process to improve their outcomes.  Sounds like progress.   Until they were shut down.

Without going into the regulatory details, the debacle centered on whether the project was a quality improvement project exempt from many federally-established regulations, or whether it was a research project that required more oversight. Vida summarized the consequence of the confusion and temporary shutdown:

While OHRP concluded in a February determination letter that the Michigan hospitals could continue implementing the checklist "without falling under regulations governing human subjects research," the implications of its initial action have been far reaching. "There's been an awful lot of quality improvement that has been stalled or put on hold, trying to understand this IRB issue," says Pronovost. "The chill sent through the quality improvement field has been very, very real."

With the national debates centering on improving electronic data and improving quality of care, why is it that our regulatory agencies are not aligned along the same goals?

Now, this is not meant to be a slam on the FDA.  I strongly believe there must be oversight of the medical field in order to protect the population. 

Instead, I believe that we need to seriously consider where we want Medicine as a field to go.  This means that we need national priorities that are not just articulated, but applied to the regulatory agencies that could potentially resist that growth.

It is easy to globally talk about “coverage for all” and “improving quality,” but without looking at some gritty details and addressing barriers to change, this will remain just talk.