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Sunday, August 24, 2014

Continued disruptions in health care

The New York times published a piece this morning titled " Blood Industry Shrinks as Transfusions Decline". The story contains multiple elements reflective of the changes and disruptions affecting the health care industry.

What is more fundamental in medicine than blood transfusions? There is some controversy regarding the first transfusion. It has been reported that Pope Innocent VIII received the blood of three ten year old boys in 1492 although it is not clear when the blood was infused or ingested. Jean Denis transfused lamb blood into a young woman in 1667, a procedure complicated by a hemolytic reaction which fortunately for the patient, she survived. Unfortunately for Denis, reactions in subsequent reactions were not so benign, resulting in madness and death. The practice was dropped and not undertaken at all for the next 150 years.

In the 19th century, various attempts to revive the practice lead to variable successes. However, it was not until Karl Landsteiner began to define human blood groups in 1900 that more widespread deployment of human to human transfusions could be undertaken. Blood group characterization was then refined over the next 100 years. In addition, a host of other technological breakthroughs including anti-coagulants, preservatives, refrigeration, sterile (or clean)  technique, material science (plastics), and screening for infectious diseases made the practice safer and more effective. It was during war that the much of the practical improvements were driven with life saving impacts.

As noted in the NYT piece, blood banking and the American Red Cross moved to an industrial scale after WWII, about 70 years ago. However, the heyday of transfusion medicine may be behind us. The demands for transfusions are down a almost by a stunning one third in the past five years. This appears to be due to multiple factors including the use of minimally invasive surgery, substitute products, and changing indications for use of transfusions.

Regarding the last factor, decision support tools linked to electronic health records may be having a profound effect. While changing recommendations regarding medical indications may have limited effects if deployments are dependent upon individual physicians embracing the changing recommendations, the same recommendations tend to be adopted more readily if reminders and prompts are embedded in computerized physician order entry systems (CPOE). Orders entered which are at odds with guidelines require some sort of physician action to override the defaults which are also tracked. This has changed the use of transfusions and discouraged what is now viewed as inappropriate use.

The drop in use has prompted a host of consolidations and cost savings activities. The industry is shrinking in terms of employment footprint. As noted in the Times article (emphasis mine):
The change has come as a shock to workers. Marjorie Krueger, the administrative director of the Communications Workers of America for the area including Virginia, West Virginia, Maryland, Pennsylvania and Delaware, said that when the Red Cross began laying off union-represented workers in 2010, “We honestly didn’t know how it would work, because no one ever expected to have layoffs.” The layoffs have been few, but the hours of many full-time workers have been involuntarily cut to part time, she said.
Basically, transfusion medicine is 100 years old. In some sense the history of transfusion medicine tracks the history of recent modern medicine. Changes comes both rapidly and slowly. None of us practicing now has any recollection of what practice of medicine was like without transfusions, creating the illusion of a practice which has always been with us. However, the reality is it is a very recent addition to the ancient practice of caring for the sick and injured. Because of our biases, we are surprised when technology disrupts our world changes what we view as a practice which will be with forever.

The truth may very well be that use of blood is an expensive and labor intensive approach to care where the public will be best served if it can be replaced by approaches which are safer, cheaper, and simpler. Come to think about it, this sounds like the current health care system in general. Be prepared for change. Be prepared for disruption. Don't be surprised.

Friday, August 22, 2014

Would I want to be in GI training now?

First came the paper suggesting that flexible sigmoidoscopy (average cost $500-$750)  perhaps was as effective as  colonoscopy (10x the cost) in preventing colon cancer deaths. The FDA has recently approved the Cologuard test (FDA story) and Medicare wants to fast-track the approval of coverage. The estimated cost will be around the same as the cost for flexible sigmoidoscopy.

In the clinical trial Cologuard detected 92% of colorectal cancers (8% false negative rate) and 42% of precancerous lesions. The trial involved over 10,000 patients scheduled for screening colonoscopy, which subsequently identified colorectal cancer in 65 patients and advanced precancerous lesions in 757. The test reportedly has an approximately 13% false positive rate of diagnosis. Doing the math, this means that the test detected 60 of the 65 cancers and 325 of the adenomas. However, it was found to detect almost 70% of the adenomas believed to be most likely to progress to cancer. With a 13% false positive rate, this means that about 1300 people were found to be positive for the test who were clear on colonoscopy. 

How does this compare to fecal occult blood testing? Fecal immunological testing (FIT)  was 73% sensitive detecting only 48 cancers. However, it had only a 5% false positive rate.

Of course there are questions and doubters. In the LA Times, they quoted the head of the endoscopy unit at UCLA:
Dr. Bennett Roth, a professor of gastroenterology at UCLA, took a more measured approach to Cologuard. He said the test is still a work in progress, "but it's a move in the right direction." Roth said, is that it could encourage more people to have a colonoscopy, which remains the gold standard for diagnosing and treating colon cancer. "Maybe if you get a positive test with Cologuard, you'd be convinced to have the more definitive test," he said. "It doesn't replace the need for a colonoscopy."
I am not so sure I would interpret the results this way.  Colonoscopy is not without its issues. There is reported incidence of serious adverse events of 2.8/1000 procedures. Eight people per 10,000 patients screened will have a perforation. Hemorrhage occurs in 1-6 per 1000 colonoscopies.

Furthermore, colonoscopy is far from perfect (reference). The cancer miss rate (false negative) is reported to be as high as 6% and the adenoma miss rate for tumors greater than 1 cm is 12-17%. Perhaps some of the false positives detected by DNA testing may not be false positives at all?

I have news for Dr. Roth. Perhaps your position heading an endoscopy group has clouded your thinking about value. I cannot help but think that if I were to go and ask a president of a life insurance company about the value of life insurance, I might get a similar skewed perspective. Of course everyone should have life insurance!

I have had my colonoscopy when I was around age 50 and  soon enough someone will raise this with me again. Hmmm... let me think about this? There is a test available which is nearly as sensitive, with no prep, no anesthesia, no invasive risks, and it can be obtained at a fraction of the cost....Can you say no-brainer!

Let me do some additional math. This test roughly may eliminate the need to do over 80% of the $14 billion colonoscopy market. As Dr. Roth noted, perhaps this test may convince selected people to undergo colonoscopy, since 1/3 of the targeted screening group (50-75 year olds) are not screened. Even capturing this entire group, you would only expect perhaps 10% of these people to undergo colonoscopy.

I think any way you look at this this test represents a likely disruptive technology which will change the economics of GI medicine. Perhaps there are aesthetic medicine opportunities. Everyone else is doing it!

Sunday, August 17, 2014

Medicare care coordination payments

Medicare announced that it will begin to pay selected primary care physicians for care coordination beginning early next year. The article describing the announcement was published in the NY Times today. I welcome the idea that there is value in activities which happen outside of the office but as far as I can determine from the limited information available, the way that Medicare is undertaking deployment is seriously flawed.

It seems that the value to care coordination is assessed to be very modest with estimates of payments of about $42/month. The specifics of the deliverables is somewhat vague, with the exception being the requirement of 24/7 on call coverage. The language noted in the Times was:
Under federal rules, these patients will have access to doctors or other health care providers on a doctor’s staff 24 hours a day and seven days a week to deal with “urgent chronic care needs.”
Who knows what urgent chronic care needs might be? I suspect it will be defined as anything which is deemed urgent by the patient at any given point in time, which is a rather open ended commitment for 42 bucks per month.  However, if one has a large Medicare practice, it is not an insignificant sum of money which we are talking about. It is "concierge-iod" but at the low end of fees. At about $500/year, a practice which has 500 medicare patients will see an additional $250,000 per year. Is that enough to provide the additional services and enough left over for a bit or margin?

I have to raise the question as to whether now that Medicare offers this as a covered service, whether it makes the marketing of non-Medicare concierge services to Medicare patients  illegal?

While the story was reported on in major newspapers, I could not find anything on the CMS Website giving further details.  The one size fits all pricing fits with the typical contempt Medicare has with price signals in health care. It is an open invitation to cherry pick, assign the relevant chronic disease designations whenever possible, and look to amass the least sick, chronically ill populations that you can while developing the most effective strategies for avoiding patients who require after hours attention.

Let the games begin.. yet again

Economics always trumps evidence

One of the basic tenants of economics is that people respond to incentives. One of the most powerful incentives are monetary ones. As my oldest child describes this, "We are coin operated. "

Which brings me to a recent study published in JAMA - “Effect of Flexible Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality“. This study demonstrated that screening patients with flexible signmoidoscopy decreases the incidence of colon cancer and death from colon cancer. It was a large study involving tens of thousands of people in Norway. This was the fourth study which showed similar effects. They were not huge in terms of absolute numbers, lowering the mortality from 4/1000 to 3/1000 over the 11 year interval in which patients were studied.

In the accompanying commentary by Allan Brett, the author points out that while flexible sigmoidoscopy demonstrates this benefit, the same has not been shown for colonoscopy, the more difficult, expensive, and risky approach to screening. Yet, colonoscopy has all but completely replaced the use of flexible sigmoidoscopy. Will this new information cause the pendulum to swing back toward use of the flexible sigmoidoscopy? I doubt it since the economics are so compelling.

As Dr. Brett notes in his commentary, patients are nudged by AGA guidelines identifying that the colonoscopy approach is the "preferred" strategy. Attempts to have a more nuanced discussion are really not feasible (likely true) and why not drive patients to the procedure that creates this highest margins? One does not need to be in the pocket of drug companies in order to be financially conflicted. You just need to be practicing medicine.

Perhaps it is not fair to single out the gastroenterologists,  since this type of thinking is absolutely rampant within current medical practice. It just seems that the economic underpinnings of this particular specialty may become unraveled rather quickly. As noted by Dr. Brett and in a cited piece by Stacey Butterfield in the ACP internist (Changes in colon cancer screening), next generation stool DNA testing may replace an expensive and cumbersome test with a simple stool test. I am sure that this will not happen without a real fight because as noted by David Lieberman, MD who was quoted in the ACP piece, "Colonoscopy has been really good to the specialty. It has been the goose that laid the golden egg".

I guess gooses don't live forever. The question is whether we should be working toward goose immortality.

Saturday, August 16, 2014

Everything you know is wrong

I recently read a book titled "The big fat surprise" by Nina Teicholz. In this book she reviews the history of low fat diets as a healthy approach to eating. As the pages turned, I could not help but recall the movie "Sleeper". In this movie,  Miles Monroe (played by Woody Allen), a jazz musician and owner of the 'Happy Carrot' Health-Food store in 1973, is subjected to cryopreservation without his consent, and not revived for 200 years. After waking his requests for breakfast are viewed with some disbelief.

Dr. Melik: This morning for breakfast he requested something called "wheat germ, organic honey and tiger's milk."
Dr. Aragon: [chuckling] Oh, yes. Those are the charmed substances that some years ago were thought to contain life-preserving properties.
Dr. Melik: You mean there was no deep fat? No steak or cream pies or... hot fudge?
Dr. Aragon: Those were thought to be unhealthy... precisely the opposite of what we now know to be true.
Dr. Melik: Incredible.
It seemed as though it was a joke when the movie aired in 1973 but the truth does not appear so humorous. The joke may have been on us for buying into what may very well be low fat nonsense. As the book describes, the origins of the diet which can be traced back to Ancel Keys, an American physiologist from mid 20th century. The book goes a long way into discrediting the purported science behind the diet, convincing me for one that perhaps significant harm has been foisted upon the American public. The data to support such a massive experiment upon the public was thin at best and perhaps better described as a massive fraud. The work represents a terrible indictment of the scientific peer review system as well, where peer review functioned only to squelch contrary (and what appear to be more accurate) opinions for over 60 years. I have already begun to change what I eat, incorporating more fat and in particular saturated fat. 

This particular set of dogma is not the only dogma now coming into question. Just this week there was a study published in the NEJM which followed more 100,000 people from 17 countries and found that those who consumed less than 3 grams of sodium a day had a 27% increased risk of death. The follows on the heels of a recent IOM report calling into question any cardiovascular or mortality benefits from lowering sodium intake below 2300 mg/day. The American Heart Association remains unconvinced, much as they remain unconvinced about issues with low fat diets. 

Although it garnered limited press, the Cochrane group reviewed studies which examined the benefits conferred from the treatment of mild systolic (140-159 mm Hg) or diastolic hypertension (90-99 mm Hg). (Cochrane Review) They reviewed studies including almost 9000 participants. They were able to demonstrate no effect on morbidity or mortality in the treated group and almost 10% of those treated had to discontinue treatment due to side effects. So why is aggressive treatment of BP in the demographic being used as a quality metric?

There is a theme here. In an attempt to improve the health of people, influential organizations have undertaken grand plans and schemes and based upon the trust which the public has placed in these organizations, massive campaigns have been undertaken. Driven by "hedgehogs" who pressed their agendas forward with little doubt they were doing the right thing, staggering numbers of people were the subjects of what amounts to be huge and uncontrolled experiments. Very disturbing...

Saturday, June 28, 2014

How best to communicate?

I had a very interesting conversation with colleagues tonight regarding optimizing communications within a health care network. It has always been a pet peeve of mine that communication networks among physicians tend to be very ad hoc in their functioning and information exchange. There was agreement within the group that something needed to be done. However, there was no consensus on exactly what optimal communication strategies should look like.

One of my colleagues who is an orthopedic surgeon, thought the best tool for his communication needs was the phone. It was his opinion that this approach afforded him with the fastest way to get the information he needed to ascertain whether he needed to see the patient or not and he was perfectly willing to use his time in a non-compensated fashion to avoid filling one of his new patient slots with a patient that would not feed his operative machine. For him, it seemed that the only reason to communicate with his fellow docs was to make sure that he did not interrupt the flow of good operative candidates into his office. There were merits in this communication approach in that it can address the concerns of primary care physicians and patients in real time and perhaps serves their immediate needs.

Still I have somewhat of a different perspective on the need for synchronous, real time communication, particularly by using the phone. When that encounter he describes is over, the only record of what was asked and what was said exists in various parties' minds. Presumably there was some sort of information shared with the consultant, some of which he heard, some of which he did not, and of the part he heard, there is some fraction of that he retained. In response, he made an assessment which was communicated to the consulting party, likely with a set a recommendations. What parts of the assessment and recommendations were heard and retained by the consulting physician shares the same limitations.

At some point, the assessment and recommendations get transmitted to some part of the medical record. I would venture to guess that at least part of this will be attributed to the physicians who gave his recommendations over the phone. How closely these track with what was said or intended is anyone's guess. Whether this note gets forwarded to the consultant is unlikely, meaning in some sense hearsay is documented in the medical record. Alternatively, nothing is recorded at all. It may be that none of this actually matters in that little or nothing was really at stake. Who really knows? We will never know since the record of this type of encounter and call will always be incomplete and error filled until we deploy software which records and parses everything we say and hear.

Am I being a nit picker about this? Is accurate communication important when dealing with someone's health? Imagine the legal system where a similar standard for communication was used? What is it about health care where we settle for spoken instructions and written records riddled with errors and imprecision?

I think this is part of a much larger issue regarding the best use of information to support decision making and coordination of care. Neither of these tasks are really priorities in the current world. Information collection is ad hoc. Decision making is very intuitive and system one based. In a world where there are few consistent feedback loops, any decision which is roughly equivalent in terms of financial outcomes becomes acceptable. Coordination of care is much talked about but also done in an ad hoc manner with no real rules of engagement. I talk to you and you talk to me. I think I hear what you tell me and you think that you hear what I tell you. I think I get what I want and you think you get what you want, and no one has any real idea of whether the patient gets what they need, unless their only priorities are to be dealt with quickly but not necessarily effectively. We prioritize speed and "efficiency" and that is what we get, nothing more and nothing less.

Thursday, June 26, 2014

Unbridled Power - The IRS and record keeping

The latest news regarding the IRS and emails reminded me of a book I read over 15 years ago titled "Unbridled Power: inside the secret culture of the IRS" by Shelley Davis. Ms. Davis was the first and likely last official historian of the IRS. She had a long career as a government historian, working for the Air Force and Defense Department Mapping agency before her employment at the IRS.

Throughout the federal government, there a professionals whose job is to manage documents in their agencies, reviewing them and forwarding relevant ones to the National Archives. This is what Mrs. Davis did in her previous roles in the Department of  Defense. When she arrived at the IRS she discovered that the IRS basically had no clear record retention policy and were engaged in a struggle with the National Archives to resist archiving IRS records. She testified to this effect to before the Senate finance Committee Oversight Hearing on Internal Revenue Service, Tuesday, September 23, 1997 (Shelley Davis Senate Testimony).
From her testimony:
My introduction to the culture of the IRS came during my earliest days with the tax agency, in the fall of 1988. Although I had been hired as the first historian for the IRS, I found little interest or support for my efforts. I found even less history. By history I mean both an awareness of the heritage of the IRS as well as the raw material (the documentation) from which narrative history is distilled. Neither the documents nor the heritage were to be found. Initially, I found this curious. Later, I found it alarming. At the IRS National Headquarters, there seemed little connection between the work of employees and actual tax collection what I presumed to be the mission of the IRS. Rather than possessing any basic curiosity about the past, the IRS employees I encountered exhibited a wariness, a suspicion assuming that anyone looking for records must have some definite agenda. An agenda presumed to be negative.
This reluctance to think about the past translated into routine day-to-day operations, meaning that all documents were tossed, shredded, whatever, when a program was completed or shut down, as in the case of many IRS computer projects. No records. No paper trail. No history.......
......A corollary to this defensive shield is the penchant of the IRS to destroy its paper trail. There were virtually no records of IRS actions throughout the twentieth century in any of the repositories where one would normally find federal records: the IRS itself, the National Archives (including the permanent archives in Washington, D.C., the 10 records centers around the country, or the Presidential libraries.)
In my early years with the IRS, a good question to ask was, "Where are the records?" What I learned was shocking. The records had been destroyed. Gone. Shredded. Tossed. They no longer exist due to a lack of attention to, or concern for, the law which requires all federal agencies to preserve records of what they do. It is as though the IRS assumed that laws which apply to the FBI, to the CIA, to every other part of the federal establishment can be ignored. No other agency of our government could get away with this. I questioned the reason why it had taken so long for anyone to realize that the records were not just missing, but destroyed. I believe the answer is based on fear. As taxpayers, why would we ever question the one agency that can truly bite back? 
Does this sound familiar? While at first I simply could not believe that the IRS could believe they could get away with such flagrant abuse of the law, I now realize that why shouldn't they believe so. They have been doing this for years. Shred paper documents or shred hard drives. What is the difference?

This has been going on for years. 1997 GAO report