Archive for September, 2014

Medical Devices — where are the regulators?

undertable

Corruption 101:  medical device makers.  It’s unbelievable that in the same week we get reports of device makers paying physicians billions of dollars to use their products while the FDA approves devices with skimpy rules and secret files.

To pay cardiologists to “research” how a pacemaker works after the device is mass produced is like giving a coupon to a housewife to “research” a new laundry detergent.  Except, the laundry detergent costs $5 whereas the pacemaker costs $30,000.  This is a kickback and it is unethical (because the doctor gets the money and the patient gets no benefit).

The idea the FDA can and does approve new models of pacemakers without proof they are safe is beyond comprehension.  Many of the recent recalls involve defective pacemaker electrical leads — new models are OKed without materials testing or prolonged flexion testing that most engineers would expect.  Even Consumer Reports lab could do a better job.  A car recall is one thing, but cutting a patient open and jerking out a defective pacemaker wire from the heart is something hugely different.

Self policing of device makers has failed — we need regulations with teeth.  In addition to safety regulation a limitation on device profit is badly needed.

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5% of Patients, 50% of Cost — where to focus

EmergencySocialThe U.S. spends more than other countries for health care but the outcome is not as good as other countries.  Why?  Many feel it is a failure to respond to the statistic that 5% of patients consume 50% of health care spending.  And, those 5% are often at the bottom of the socioeconomic ladder — either they started at the bottom or drifted to the bottom because of health problems.  See the recent article in Manage Care Magazine.

The health care solutions for the top 95% don’t work for the bottom 5% — because the 5% are not well educated, have unreliable transportation, no phone, smoke cigarettes, and only have part-time jobs.  No matter how much research is done on new drugs and surgical robots if a patient does not have transportation to a health care provider it is money down the drain.

Face the facts:  Sweden spends more money on social services than health care.  The result:  infant mortality rate in Sweden is 1/6 th of the rate in the U.S.   Overall, Sweden spends less on health care and delivers much better results.

Here are the 2009 statistics from the Organization for Economic Cooperation and Development (OECD):

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costperperson

Countries with much higher health care quality (like the UK and France) spend at least twice the amount per person for social service as in the U.S.  The fragmented U.S. healthcare system fails to FOCUS on obvious problems — social service seems to be a lens to sharpen that focus.  It’s easy to see the return on investment for the system when social service provides transportation, navigation through difficult medical situations, health education, home vaccinations, and frequent contacts with pregnant women when needed.  Health care without social service is like building a house without one of the walls — looks great from one side only!

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Ambulatory Surgery Centers — where’s the data?

undertherugAmbulatory Surgery Centers (ASC) are adept at hiding problems.  Just try to find death rates, numbers of transfers to hospitals, organ punctures, and surgical procedures required to correct errors.  Nope — you won’t find those crucial bits of data for public view.  Here is a link to statistics collected for “internal” review:  Quality Reporting Program.

As with most health care entities the public expression of “quality”  is “certification” — which means an outside reviewer thinks the organization has the right programs and procedures so nothing stands in the way of quality care.  Likewise, nothing usually stands in the way of a student getting an A+ on a test — but A+ is not always the grade.  As Confucius says: “there are always greater and lesser”.

So, as a patient, what should you look for; what questions should you ask?

  • Is the ASC certified?  If not, find another ASC.
  • How many patients does the surgeon treat at the ASC  — expect at least 10 per week.
  • How often does the surgeon do the procedure you need at the ASC — expect at least 10 per month.
  • Will you be sedated? — if so, make sure an anesthesiologist or nurse anesthetist will be monitoring you while sedated — if not — find a different ASC.
  • How close is a hospital if you have one of those serious complications listed in the consent-for-surgery form?  If an ambulance would take more than 10 minutes to get you to the hospital consider another ASC.
  • If you have severe heart or lung problems (like a history of congestive heart failure or COPD) consider having your procedure at a hospital rather than at an ASC.
  • Ask if a pre-op check list, like the one the World Health Organization recommends, is used for all surgeries — if not, quality is a questionable.  If the surgeons says they don’t need a check list find a different surgeon.  Keep this in perspective — every airplane pilot must follow a pre-flight checklist, is your surgery any less important?
  • The person that comes with you needs to write down what the surgeons says after the procedure.  Patients who have been sedated, even if they seem fully awake, will have impaired memory for many hours.  Have the person with you write down what was found at surgery — what is the diagnosis and what are the specific instructions.
  • Absolutely avoid late afternoon surgery — because you will be shipped to the hospital for minor complications — the ASC will close and they don’t have staff to provide care after closing.

 

 

 

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Something Less than an Ambulance — will it fly?

ambulanceER doctors never ask the question but often think: “Why did you call an ambulance for a sore throat?!”  The trip costs at least $1000 and stands a chance of not being covered by insurance.  The ambulance crew feels bad they don’t have a more appropriate option but if you call an ambulance — you get an ambulance.

Kaiser Health News reports the South Metro ambulance company in a suburb of Denver Colorado is trying a new service.  An ambulance that is basically an ER in a box.  Equipped with lab tests, bandages, sutures and a few medications they go to a home to treat a problem rather than transport a person to the ER.  It costs about $500 — at this point, it is something insurance will not cover.

Here are two extremes:

  1. A single parent picks up their child from a family member after working 2 jobs at fast food restaurants.  The parent just got the jobs after 3 months of being unemployed.  The primary care doctor’s office is closed and the parent is expected at work in about 7 hours.  But, the child has a fever and a sore throat. The bus they usually catch to go to the hospital does not run after 8 PM.  The parent calls an ambulance.
  2. A woman drops a martini glass and cuts her finger.  Her husband thinks she needs stitches but he has some after hours stock trading to do before bed.  He tells the butler to call an ambulance and get the problem resolved.

The first case is common for Medicaid families.  No resources, no car, and not much to lose by calling an ambulance.  But, something to gain by not missing time at a new job and it helps the child on both counts.  The ambulance and ER visit may cost Medicaid over $1000.  But, during the day a visit to primary care might only cost $50.

The second case is crying for concierge care.  The family has the cash to pay for someone to come to the house and put a few stitches in a finger.  But, instead the problem clogs up the ER that should be dealing with heart attacks and car wrecks.  Again, if the problem happened earlier in the day a primary care office or urgent care clinic could have solved the problem.

One could see Medicaid having a fleet of mobile treatment units just to limit the financial losses in the ER.  Actually, a good idea.  Both cases might have solved their problems by taking a taxi to an urgent care clinic — if one was open.

Will the “ER in a box” find a place? — at least a place where someone will pay them?  The idea leans toward the concierge model.  No insurance is going to pay for an ambulance when a taxi will work.  No insurance company will pay extra just for the convenience of one patient.

Nice idea, but it’s not likely to fly financially.

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