Health Data Rights – Your Lab Results

in what is an aberration in the current law laboratory results are treated differently:

Federal regulations under the HIPAA Privacy Rule treat test results as a special case, separate from other protected health information. CMS has issued regulations that further state that results can only be delivered to “Authorized Persons”, which as it is currently defined does not include the patient who is the subject of the test.

You can find out more at HealthDataRights.org and the consensus letter here. As they state there is an opportunity to provide input tot he regulation and support a change ot the rules to allow easier access to your patient data to include laboratory data:

On Tuesday, the Health IT Policy Committee at ONC is holding a hearing regarding CLIA laws and access by consumers to their own test results. We have a unique chance to speak with one, resounding voice that the federal barriers to patient access to test results should be removed. Dr. Phil Marshall of WebMD will be testifying at the hearing, and he will be presenting the linked consensus letter http://www.healthdatarights.org/pdfs/CLIA-Letter.pdf that provides background on the issue, recommends two common sense ways the federal laws can be changed to allow greater access, and the benefits of making those changes. This letter has been vetted by some of the top health data experts and health data privacy lawyers. Here is a summary of the letter and what we’re asking you to do.

Sign up, declare your rights and help support this initiative to gain access to your patient data or send an e-mail to declare yoru support action@healthdatarights.org

H1N1 Vaccination

Recent discussions with friends and the extent of confusion suggest that some guidance on the latest flu challenges and vaccination choices.

Some facts:

• The Current strain of concern is H1N1 (the misnaming of “swine” flu arose from one of the early outbreaks of the disease in pig farm in Mexico – “Quadra flu” might be better)
• Severity varies
• At Risk or High Risk groups are at (no surprise here) more risk of serious complications
• The Young (in this case defined as <25 years old) appear to be more susceptible to problems/risks

The vaccination concerns center on the vaccine being “untested” but as the CDC points out

This vaccine will be made using the same processes and facilities that are used to make the currently licensed seasonal influenza vaccines

And as such will have a similar profile of safety as he seasonal flu vaccine delivered each year. In this case the profile of the vaccine ha been modified to attenuate it for the H1N1 strain but the delivery mechanism and system remains the same as delivered each year.

At Risk Groups and Vaccination Recommendations (per the CDC):

• Pregnant women
• Carers of children , 6 months old
• Healthcare workers
• The Young aged between 6 months and 24 years of age
• Those “at risk” between 25 and 64 years old

Symptoms or Warning Signs (available from the CDC as a flyer) divided for Children and Adults
Children:

• Fast breathing or trouble breathing
• Bluish skin color
• Not drinking enough fluids
• Not waking up or not interacting
• Being so irritable that the child does not want to be held
• Flu-like symptoms improve but then return with fever and worse cough
• Fever with a rash

Adults

• Difficulty breathing or shortness of breath
• Pain or pressure in the chest or abdomen
• Sudden dizziness
• Confusion
• Severe or persistent vomiting

None of the above should be deemed “medical advice” but is an assimilation of information presented by the CDC

Abuse of Resources – Its Everyone’s Responsibility

I spent the last weekend up to my neck in organizing a local soccer tournament with 280 teams, hundreds of games and thousands of participants. Weather challenged our scheduling with severe thunderstorms and rain but we managed to pull off most of the tournament and get everyone to play their games.

We had some injuries including at least one fracture to an arm, some cuts bruises and even some concussions. Local services provide excellent coverage and I have experienced the great response and work when I refereed a game when one of the players fractured their leg in a hard tackle. The local ambulance crew arrived quickly, drove onto the field to collect the player and took them to a nearby facility and where they received excellent care.

Since I am part of the tournament staff and easily identified I get included in much of what is going on. In once such instance one of the facility organizers stopped me to tell me that the medical crew were pulling in to the back to deal with the bee sting. I was immediately concerned thinking about anaphylactic shock and followed her outside to meet the ambulance crew and the police escort to get them across grass fields. The local facility staff meets the crew and says:

She’s inside

Wait a second I just walked out from there and I did not see anyone lying comatose on the floor? Did I miss something? We proceeded inside and I look at the patient. An middle aged lady sitting on a chair with one foot partially obscured with a bag of ice……..!

My initial thought is there’s some mistake the patient must be in a room nearby. But no – this is the bee sting patient. The detail was correct – it was a patient with a bee sting. A bee sting on her foot.

This is an abuse of the system. Its inexcusable. I challenge anyone to provide me with any reason that could possibly justify calling an ambulance for a bee sting to the foot. There is no anaphylactic shock problem. There is no transport issue here – for anyone to have arrived at the facility they had to drive or be driven.

This is inexcusable and there seems no other way to curb this wasteful selfish behavior that by imposing financial penalties. That individual should be required to pay for the cost of the ambulance, the crew, the park escort and any subsequent treatment she received in the Emergency room – at the full rate. No insurance coverage or subsidies.

Unfortunately that position is a slippery slope and will quickly lead to the requirement to justify every call for an ambulance and visit to the ER. Fine in such cases of flagrant abuse but what happens when its not so clear cut or the patient believes with the best intentions it was the right call. We want to err on the side of best choice and care without inhibiting those people that genuinely need these services but are afraid to call for fear of punitive charges.

The only solution I can see is have an independent body determine justifiable use. A body that is not linked to the payors, service providers or patients. Clear guidelines and a quick independent process for review and arbitration of cases that are not clear cut.

Maybe this is already in place. No doubt it can and will be abused – but if we cannot take our own persona responsibility then we can hardly expect the insurance companies to accept this level of abuse of coverage and to pay up for in appropriate use of expensive emergency services.

Litigation in Healthcare – The Two Sides to the Pond

I like Dr Crippen’s blog and enjoy reading his posts and commentary. He typifies the long suffering British doctor in many respects. He rails into waste as in this post on the ridiculous expenditure by Essex health commissars (!!) insisting on spending who knows how much on educating the population that they should eat more fruit and nuts. As Dr Crippen says:

..most of all, it is a waste of money. The hospital is on fire, burning to the ground. Why is no one doing anything? Where are the fire-fighters? They are in the local school lecturing children on the dangers of matches

But in this recent post: Paranoid Doctors he is distraught that in the US attorney’s advertise their services and offer a “No recovery, No Fee” option. As he puts it

So I can stop my medication. And thank God we don’t live in America

Yes and no…… as one of the comments on his post put it:

How would you respond to a patient whose GP had been giving him Steroid eye drops on repeat prescription for 11 years without reviewing him and who was not under the care of an Ophthalmologist, who now has bilateral steroid induced glaucoma and steroid induced cataracts?

I bet you dollars to donuts that this is a real case not just a hypothetical and therein lies the challenge. While there is abuse (as there is in any system) the idea that making it so costly and difficult provides good protection for the patient is wrong. A very good friend of mine was treated for a complex fracture of radius and ulna at some local hospital. The gung ho orthopedic surgeon decided he was up the task of treating this set of fractures and left him with permanent disability and finished his tennis career. No amount of money will ever make up for that but without accountability that surgeon would continue his treatment of other patient instead of referring them to a specialist. This all the more worrying since it occurred in the NHS a system that does not reward by number of patients/procedures carried out

For a more detailed look at the state of medical litigation this piece by Atul Gawande in the New Yorker – The Malpractice Mess provides more detail and an interesting slant on the topic. The case under review was for medical malpractice from nine years ago but what makes this more interesting is the lawyer for the patient Barry Lang was an orthopedic surgeon for 23 years. He had even been an expert witness on behalf of other surgeons defending their treatment in court. He certainly did not do it for the money and ended up in his new career because as he described:

because he thought he’d be good at it, because he thought he could help people, and because, after twenty-three years in medicine, he was burning out

Part of his original intent was to be a defensive lawyer for his colleagues but nobody would hire him as he had no experience. But as he advertised his expertise as the “Law Doctor” he managed to carve out a business working on behalf of patients. He does not take every case and in fact takes only a small percentage of the cases that comes his way. For him there are two basic requirements

1. You need the doctor to be negligent
2. You need the doctor to have caused damage

Most fail on both but when they don’t he spends time investigating and applying his years of clinical practice and experience to understanding the case to determine if there is malpractice. Many factors contribute but he takes the risk on a case since his payment is dependent on a successful outcome. There is much to dislike about a system of accountability that can reward inappropriately but accountability and review is an essential part of any high quality system.

Somewhere in this mess there has to be a better balance and approach. Malpractice is not bad – it is the abuse of Malpractice that is bad. Consider the MGH physician Bill Franklin who’s son’s developed a lung tumor that had been identified on a Chest X-Ray 4 years previously but never followed up and acted upon. His attempt to understand the reason for the failure to prevent the occurrence happening again to some other patient were met with

The (hospital) director told him that he couldn’t talk to him about the matter. He should get a lawyer, he said. Was there no other way, Franklin wanted to know. There wasn’t.

He was left with no other course than to open a malpractice suit which was won. It left an indelible mark on the son and the father and changed the way both practice medicine. But the method is still unsatisfactory

litigation has proved to be a singularly unsatisfactory solution. It is expensive, drawn-out, and painfully adversarial. It also helps very few people. Ninety-eight per cent of families that are hurt by medical errors don’t sue. They are unable to find lawyers who think they would make good plaintiffs, or they are simply too daunted. Of those who do sue, most will lose. In the end, fewer than one in a hundred deserving families receive any money. The rest get nothing: no help, not even an apology

There have been many attempts and much like the healthcare debate the special interests weigh in quickly when they feel their turf and income stream might be threatened. One such system started for vaccines where a surcharge is made to the cost of the vaccine that is placed in a fund set aside for the purpose of compensating the small percentage of people harmed by side effects. Some countries have tried to instigate systems along similar lines – New Zealand which has a set of limits, clear defined liability and importantly quick payouts (within 9 months). There are better models and solutions. The answer lies in a fair timely system that helps those that have been hurt, identifies fault in an effort to prevent future errors without over burdening the system and the clinicians.

Malpractice or some variant of oversight is an essential part of our healthcare system and needs to be included in any debate of reform but as with all things balance and informed debate is the way to go

Exercise will Make you Fat – Not!

In some recent news Time Magazine headlined a piece titled: The Myth About Exercise” which suggested that exercise was fueling hunger and making people fatter. Complete and utter codswallop! But the fact that Time magazine gets away with this kind of piece and worse yet as was featured on one diet blog has people saying:

“If Time magazine dedicates an entire cover story to it then it must be big”

Is a very worrying result. They go on – “the question health researchers are now asking is “Is Exercise really needed for weight loss”

Good grief – who writes this stuff. Providing even a small element of hope for the already overweight population that is getting fatter and unhealthier is just plain wrong. You can see some great presentation of economic and health trends at GapMinder here (Presented at the equally great site of TED Talks by Hans Rosling).

Even if there is a shred of truth to any of the report we need to be encouraging exercise not discouraging it. Our population needs exercise – in fact your body needs exercise
Don’t loose site of this goal of regular and frequent exercise.

As Rebecca Scritchfield pointed out in her blog of this media disinformation is a big price we pay for listening to this tripe. As she says

the reality is the science tells a totally different story: There is strong evidence from the majority of the scientific literature that physical activity is an important component of an effective weight loss program; Physical activity is one of the most important behavioral factors in weight maintenance and improving long-term weight loss outcomes. In fact, participation in an exercise program has proven to be the very best predictor of maintaining weight that was lost; Effective weight loss and maintenance depend on a simple equation called energy balance: Calories expended through physical activity and normal lifestyle functions must exceed calories consumed; It is a myth that exercise can actually prevent weight loss by leading exercisers to overeat. Research and common sense disprove this notion. Look around the gym or the jogging trail. If this were the case, wouldn’t those who regularly exercise be the fattest?

Quite! Don’t get duped by the media’s desire for sensational shock stories. There is more on this blog with Good Morning America bringing on an “expert” nutritionist providing a platform to someone who as Rebecca points out”

ANYONE can call themselves a nutritionist. You can. Your grandma can. President Obama can.

So from this nutritionist I am here to tell you exercise is good and an essential part of a weight loss and positive health program. So get off your chair, turn off the computer and go for a walk..it will do you some good. Then Rinse lather and repeat!

Self Care and Management

In a great post by Don Kempler (CEO of Healthwise) on the Healthcare Blog titled “Patient Heal Thyself” the challenge of health management and the over usage was very clearly addressed by comparing two families – the Jones’ and the Smiths

The Smith family represents the vast majority of healthcare usage in the US – Doctor knows best and is typified in my experience with the frequent visits for every ailment that crops up. The Joneses are at the other end of the spectrum and much more conservative using the information they find and more importantly applying it as part of their interaction with their physician

For the same condition of back pain they represent the cost both financially and also from a health perspective
The Smiths (Doctor knows best):

When Sam Smith’s back pain flared at age 45, he was quick to accept his doctor’s recommendation for an MRI and a visit to an orthopedic specialist to make sure it wasn’t serious. The MRI showed a possible cause of the pain and (just to be sure) Sam had surgery the following week, marveling at the efficiency of the system. The cost: about $40,000 for surgery, hospital, physician care and rehab.

For the Joneses with the same condition:

When Jay Jones, also age 45, had an identical bout of back pain he reviewed a back surgery decision aid on the Web—even before his first visit. He learned that back surgery is not usually needed or always successful. For him the case for surgery was not very strong.

When his doctor recommended an MRI, Jay pointed out that a decision aid helped him learn that 50 percent of back pain cases go away in four weeks, 90 percent in six months, and only 10 percent of back pain cases need surgery. Jay also learned that MRI reports often find things that can lead to surgery even though they were not the cause of the pain. With that information he asked if he might put off the MRI and the surgery while he determined if his back would get better on its own—it did. The cost: $150 for the office call and $12 for the over-the-counter medications. Back surgery is among the most over prescribed treatments.

Now not everyone is comfortable with the self diagnosis and I blogged about that some time back in this piece on online symptom checkers but that the point is not to defer the whole diagnostic process to technology but to use the technology to help support decision making.

I know where our family is (sometimes to the chagrin of my own children who feel I am less than sympathetic) – we use the services when we feel we need them and are very conservative. Intervention and investigation is not always good as we discovered in the hospital I commissioned a number of years ago. To check the equipment the staff were asked for volunteers to test the MRI machine – it was a very short run as no soon as we put people into the MRI but we discovered “abnormalities”. In this case abnormalities that were not abnormal but normal variations but the cost in time and investigation was high on the institution and on the individuals and the tests ere stopped.

Using good judgment and being a Jones family is better for your health and better for your wallet.

Which family is closest to your style. Had good or bad experiences with either style – let me know

The Fountain of Youth Available Now – Side Benefits Included

It is no big surprise to see the results of a recent study of a long running study of primates that shows significant value in a low calorie diet. This article reported on MedPage here in July 2009. The headline here:

researchers have shown that restricting calories in primates maintains their youth and prevents age-related disease

Let me state that again:

researchers have shown that restricting calories in primates maintains their youth and prevents age-related disease

The research is exciting since this represents a real way to reduce disease and extend high quality life. Unfortunately the nature of society today makes for an interesting slant on this information and so the the researchers are interested in the possible short cut that this research might help develop:

open the door to drugs that would mimic so-called caloric restriction

Sigh……..so much better to actually use the information to drive healthy behavior.

The effect has been know for many years in other animal models and a peak into other research papers reveals similar findings. The Annals of New York Academy of Sciences 25 Jan 2006: Caloric Restrictions in Primates demonstrated caloric restriction (CR – the fancy term for low calorie dieting) has significant benefits:

that reproducibly extends mean and maximal life span in short-lived mammalian species. This nutritional intervention also delays the onset, or slows the progression, of many age-related disease processes. The diverse effects of CR have been demonstrated many hundreds of times in laboratory rodents and other short-lived species, such as rotifers, water fleas, fish, spiders, and hamsters. Until recently, the effects of CR in longer-lived species, more closely related to humans, remained unknown. Long-term studies of aging in nonhuman primates undergoing CR have been underway at the National Institute on Aging (NIA) and the University of Wisconsin-Madison (UW) for over a decade. A number of reports from the NIA and UW colonies have shown that monkeys on CR exhibit nearly identical physiological responses as reported in laboratory rodents. Studies of various markers related to age-related diseases suggest that CR will prevent or delay the onset of cardiovascular disease, diabetes, and perhaps cancer, and preliminary data indicate that mortality due to these and other age-associated diseases may also be reduced in monkeys on CR, compared to controls

But the latest research linking this finding to human’s is more recent (though in all honesty is this surprising to anyone!). But the news is even more exciting. The low calorie group had some additional side effects:

• Zero incidence of Diabetes in the CR group (compared to 30% in the other group)
• A reduction in incidence of Cancer of 50% in the CR group
• 50% reduction in Cardiovascular Disease in the CR Group

Do you need anymore incentive on healthy living? I know I don’t! Reduce your calories now – your body needs you to!
Technorati Tags: Calorie Restriction, Low Calorie Diet, Fountain of Youth

The Food Industry – New Tobacco

Its a radical idea but a recent article in the NY Times (How Food Makers Captured Our Brains) lends some credence to the idea that the food industry is behaving much like the tobacco industry was some years back (and probably still today). They engineer their food and the contents to make it as addictive as possible. This is done with no regard to health or health consequences. Their desire is to hook us to their product making us want more. Dr Kessler (Pediatrician that has served two presidents in his role at the FDA) has recently published a book: The End of Overeating: Taking Control of the Insatiable American Appetite)

My original supposition that I have shared with others was centered on sugar as the key ingredient akin to Nicotine – addicting and the reason why my kids have always preferred <INSERT: name of Fast Food Chain> Hamburger when compared to a home cooked Hamburger. But it is likely more about the combination of foods that is achieving this level of addiction:

food companies certainly understand human behavior, taste preferences and desire. In fact, he offers descriptions of how restaurants and food makers manipulate ingredients to reach the aptly named “bliss point.” Foods that contain too little or too much sugar, fat or salt are either bland or overwhelming. But food scientists work hard to reach the precise point at which we derive the greatest pleasure from fat, sugar and salt. The result is that chain restaurants like Chili’s cook up “hyper-palatable food that requires little chewing and goes down easily

The Snickers bar, for instance, is “extraordinarily well engineered.” As we chew it, the sugar dissolves, the fat melts and the caramel traps the peanuts so the entire combination of flavors is blissfully experienced in the mouth at the same time.

As he points out much of this is not about will power but the daily challenge we face in the over stimulated world of food. Knowing your own triggers (good and bad) is a great place to start. I know my own personal bad trigger is in the evening…I’ve been good all day and want to sit back and unwind and have big urge to head for anything sweet. My strategy is to deflect to an alternative in my case some type of herbal tea. This works well int he winter but is not as easy in the hot summer months when hot tea is less attractive. As with many things this is a journey not a destination. Who knows someone might have a good suggestion for an alternative that suits me – let me know I’ll share any that I receive.

There are no quick fixes and we and our children face this challenge on a daily basis but understanding what is affecting us and developing coping mechanisms can be a great start.
Technorati Tags: Fast Food, Healthy Eating, Tobacco Industry

Aspirin Use in Primary Prevention – Meta Analysis

Aspirin has long been seen as a wonder drug with a low incidence of side effects and some significant positive effects on health. In particular the potential to reduce incidence of heart disease. SO much so tat Bayer and other manufacturer’s offer a low dose version of Aspirin that is targetted to the general public for heart disease prevention. But recent meta analysis of multiple data sets by Dr Colin Baigent from Oxford University suggests that the data does not support the general use of Aspirin in otherwise health individuals and  catch all prevention for heart disease. The material was published in the Lancet (subscription required) and reviewed on Medscape (free membership required) – as Dr Baigent put it:

We have shown for the first time that the very same people at higher risk of heart disease are also at higher bleeding risk with aspirin, which is a very important piece of information and should influence the way in which aspirin is used.

So what to do given the latest evidence. There are many strategies and tools to use and no one size fits all. In fact based on the evidence in the meta analysis:

Medicine has moved on in recent years, and we now know that we can safely reduce risk of heart disease by lowering cholesterol and blood pressure, and the drugs used to lower these risk factors are probably safer than aspirin. A person wanting to lower their risk might well consider taking a statin or an antihypertensive first and only after that add in a less safe drug like aspirin.

The guidelines have not been changed and no doubt the guideline committees will review the latest data to determine if the guidelines need to be changed but int he meantime reviewin individual circumstances, family history and your own tolerance and experience with the various choices will influence decisions.

The major increased risk shown with Aspirin therapy was that of “major bleeds” which increased from 0.07 to 0.10% per year (absolute of 0.03% increase). These increases did not depend on other risk factors, age etc. And there appeared to be no “significant” trend in the positive effects of Aspirin in people at very low, low and moderate risk. There was an accompanying editorial from a clinical group out of Utrecht in the Netherlands that tried to provide some guidance on the relative risk and who should take Aspirin but the data and advice was disputed by Dr Baigent .

So review the choices, understand the risk and make your own choices based on consultation with your doctor and reviewing the updated findings and material

We the Patient Want to be Included in Meaningful Use

There is a great post on THCB “Bringing Patients into the Health IT COnversation About ‘Meanaingful Use‘” by David Kibbe. We are looking at $34 billion of our money being used over the next several years to improve our health

After all, we, the taxpayers, will pay for all this hardware, software, and associated
training. There are many more consumers of health care than doctors or health care professionals. Shouldn’t we have a say in what matters – in what is meaningful – to us?

As is often the case the end user is forgotten. Clinicians often complain they are forgotten in the design and build of EMR’s. The same is true of the HITECH and ARRA investments for patients. Their voice is hard to hear if not completely absent. But as the article clearly points out we are already using technology and find much of what we need online without recourse or even the desire to contact our local healthcare provider. When we do the process is archaic at best and fails miserably to provide the necessary information in a form we can use. In a recent discussion in a medical office I asked the question what clinical system the office used…..they had no idea. So it was not a great surprise when I asked for my records in digital form that they looked at me with blank stares akin to the deer in headlights! I have yet to have a reasonable response to this simple request.
The suggested included elements to cater to patients for meaningful use were:

• Prevention and screening reminders. As appropriate, these should be shared along with a personal health plan and full access to one’s records.
• Patient decision aids for major surgery and procedures. This might include messaging pre-and post-surgery to help avoid waits and delays.
• Patient instructions for acute and chronic conditions. What to do at home; what signs of problems or improvements to look for; when to call if symptoms develop or improvements don’t occur as expected.
• Guided self-management messaging for chronic conditions.  Instructions in self monitoring, lifestyle, medications management, action plans, etc.
• Visit preparation for scheduled visits.  This could include questions to ask the doctor or provider and biometric instructions, e.g. the need to fast before a test.

A great start but still a long way to go since it does not guide the interoperability issues and the need of the patient to have the data in a form they can use (paper or any proprietary format just doesn’t count). You can bet we will start down this track with the usual suspects producing their proprietary system that you have to log in and set up an account for each and every office and facility you visit. None talking tot he other or sharing he information in a way that allows other systems to use. Reminds me of the status with ATM’s when you had to find your bank’s ATM since cards only worked in that ATM. It was also a non connected network (this particular fact worked in favor of an old medical school friend who used this to extract cash from his empty account after midnight when the machine was unable to check his balance and therefore had to allow him access to cash!)

Meanwhile we the consumer must fight tooth and nail with these systems and facilities that are focused on their profits and keeping their patient’s – god forbid they made it easy for a patient to select another doctor or facility by providing information that was portable. Until the incentives and the money lines up behind this it seems unlikely that things  will change dramatically.Meanwhile there is a big lobby of interested parties focused on keeping control and the information (seen as power) out of the hands of the consumer.