Holland & Hart Healthcare Law Blog

THE END OF MEDICINE: How Silicon Valley (and Naked Mice) Will Reboot Your Doctor by Andy Kessler, Collins 2007.

    Andy Kessler is an irreverent, flip and highly readable writer who poses an interesting single question and than doggedly pursues an answer, with a lot of biting asides to entertain the reader. The question is, given the exponential decline in cost of technology in Silicon Valley and its exponential increase in power and effectiveness, why hasn’t medical technology turned over the same returns to deliver more effective health care at a cheaper cost. There are a number of reasons including the inherent slowness of the treatment and study process, the FDA, entrenched economic interests and the focus on treatment rather than prevention.

    

THE EVOLUTION OF INTEGRATED HEALTH CARE DELIVERY SYSTEMS AND THE SINGULARITY

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    If one had to design a health care system that would seem doomed to failure one might start with one in which the providers of care were fragmented, independent and driven through the reimbursement system to provide ever more services that generate higher income on a fee for service basis. The system would provide care to patients who were isolated from the economic costs of the services by third party payments, through employer funded insurance coverage.  Third party payers would make their money through reducing premium payouts, by simply delaying or not paying out what they contracted to provide or extorting deep provider discounts in exchange for directed volume. The approach to care of individual patients would be ad hoc, without significant oversight. Severely ill patients would be passed back and forth by all providers like the black queen of spades in a deck of cards. Bad debts would be written off as “charity care.” Insurance premiums would rise faster than the world’s oceans in global warming. Sound familiar?

    

HEALTH CARE REFORM BILL (II): MEDICAL DEVICE TAX - CONTROLLING COSTS OR STIFLING INNOVATION

There were not any easy choices in the Patient Protection and Affordable Care Act  (“PPACA”)as amended by the Health Care and Education Affordability Reconciliation Act (“HCEAR”), except perhaps the opportunity to stick it to the perpetually tanned Rep. John Boehner (R.Ohio), by imposing a 10 percent excise tax on tanning salons using ultraviolet lamps.  The Congress did impose a 2.9 percent excise tax on the sales of medical devices which is expected to raise $2OB in revenues to fund the expanded coverage of health care reform.  (The  original proposal was for $40B.) (See section 9009 of the PPACA and section 1405 of the HCEAR)  In addition new rules on proof of safety first and the implementation of “effective research” requirements are expected to further raise the cost of doing business in  the Medical Device field.

MARKET DRIVEN HEALTH CARE IN 2057: The Movie

How about a popular movie on market based health care reform?  There is actually one out there although it hasn’t yet penetrated the cloud over the current health care debate, and surprisingly didn’t score well in the box office count over the weekend.  On the first day after the House passage of the Obama Administration’e Health Care Reform Bill as approved by the Senate and following passage by the house of a bill to amend it, it might be interesting to review a future that is at least equally as bleak as the “Tea Party”  people and their surrogates have been painting the likely affects of health care reform.  The movie presents a society in which high pressure sales people use guilt, guile and outright fraud to coerce people to purchase very very expensive electronic organ replacement devices such as hearts, kidneys. livers, eyes, knees,, etc. (called “artiforgs” ) The artiforgs can provide an electronic read out to various patrolling repossession gleaners, the status of their credit accounts.

GERMAN HEALTH CARE COST CONTROLS: A GLOBAL COMPETITIVE ADVANTAGE.

There is an interesting article in the February, 2010 issue of the McKinsey Quarterly, the on-line journal of McKinsey & Company.  The article entitled “How Germany is reining in health care costs: An Interview with Franz Knieps” provides an interesting comparison to our own struggle to control rising health care costs.  Mr.Knieps is the director general for public health care, health insurance and long term care in the German Federal Ministry of Health. 

E-PATIENTS AND ELECTRONIC PERSONAL HEALTH RECORDS (“EPHR”)

 The cost of health care is an enormous drag on the productivity of American business. When the cost of health care for employers rises to 20% of the cost of doing business in some industries, the structural handcuffs of health care costs can make the difference in economic survival or not.  The advent of electronic medical records (“EMR”) has been received in some quarters as a panacea for the achievement of improved quality of health care delivery and reduction of the crushing runaway costs of the system.

THE REPUBLICAN HEALTH CARE LIABILITY REFORM PACKAGE

 Deep in the Republican Alternative Healthcare reform proposal unveiled by Rep. John Boehner (R) Ohio on November third, (The “Common sense Health Care Reform and Affordability Act,” can be found “Division C- Enacting Real Medical Liability Reform.” This section purports to nationalize state medical malpractice and medical product liability law and procedure into a uniform federal code which provides greater protection for doctors, pharmaceutical companies and medical device manufacturers.

THE “AVIATION” MODEL IN HEALTHCARE AND AIR FRANCE FLIGHT 447

 In the 1980s the Commercial Aviation Safety Team (“CAST”) determined that eighty five percent of aviation accidents and fifty two percent  of all fatal aviation accidents were the result of cognitive error by pilots. CAST pushed for the use of systems, checklists and foolproof communication systems to reduce the human element in aviation. The result was a fifty percent decrease in aviation accidents. The success of the systems method in aviation led healthcare safety advocates to campaign for the application of the systems model to tamp down the impact of human frailty on adverse healthcare outcomes. The systems model is now a fact of life in high risk medical procedure, pharmaceutical administration and other healthcare delivery modalities.

 You can see it in the operating room when a nurse paints a sign “the other leg” on your healthy limb or where two nurses must sign off on a prescribed medication. The interest in the systems application to quality improvement continues unabated. See Kahn, et al. , “To Err Is Human: Building A Safer Healthcare System.” National Academy  Press. Washington, D.C. (2000); Stripe, et al. “Aviation Model Cognitive Risk Factors applied To Medical Malpractice Cases.” (JABFM.org.);Inglehart & Fleming, “New Patient Safety Uses Aviation System Model.” Health Affairs Blog, April 13, 2009.

 Since the 1980s and the onset of the digital age the aviation model morphed into a much more pervasive systems intervention through the surge in computer driven maintenance and operational applications, not unlike parallel developments in healthcare. The crash of Air France Flight 447 A330 Airbus over the Atlantic Ocean on May 31, 2009 thrust to the fore two separate, but related computer systems driving  both airplanes and healthcare, albeit to differing degrees. The Airbus utilized the Aircraft Communication Addressing and Reporting System (“ACARS”). The onboard computers sent ten automatic maintenance messages to Paris indicating failures in the plane’s electrical systems and decompression of air in the plane’s fuselage.

 The current proliferation of medical devices with direct internet monitoring and reporting capacity provide the potential and fact of real time reporting of human body systemic failure to medical record repositories. The healthcare mimicry of aircraft maintenance information technology is upon us and we will likely embrace the use of “wearable” computers with growing fervor in the future.

Despite the apparent differences between healthcare and aviation, the information exchange paradigm used to insure quality in the aviation industry can be implemented to reduce the impact of the aforementioned system errors in health care delivery system (sic).

Martin, Lance, “Reducing Medical Errors Using an Aircraft Maintenance Information Technology (IT) System Model,” Dartmouth undergraduate Journal of Science. Dujs.dartmouth.edu/2004s/healthcareit.pdf.

 Despite Mr. Martin’s optimism and enthusiasm there appears to two principal kinks in both the aviation and healthcare systems that need to be addressed. The first relates to the information systems. There is no question that computer monitoring systems can generate a great deal of useful data. The critical question is how to sort and present the data in a format and application that can realistically serve the needs of pilots and practitioners. There needs to be assurance that the data is correct and not affected by defective “pitot tubes” or other malfunctions and a means to sift and prioritize mountains of data so as to provide real time, meaningful input to those sitting at the controls.

 The second concern relates to the ultimate control of the mission. The Airbus A330 contains the latest in fly-by-wire technology that substantially limits the operational control of the aircraft by the pilots. This is an exclusively electric system, without manual or hydraulic features. There is a debate ensuing in the blogosphere as to the degree of control, if any can be wrested from the computers by Airbus pilots in the event of an emergency. (Think of HAL in 2010:A Space Odyssey. That would be next year.)  The issue is at what point should human beings be able to reassert control from computer systems, particularly where onboard computers are juggling conflicting information from various sensors?

 Did the computers aboard Flight 447 malfunction causing a crash or did a last ditch effort by the pilots to regain control interfere with the failsafe functioning the planes systems? Was it a combination of both or an unremediable "act of God?" We may never know the answer.

Remember, more often than not, an airliner goes down at the end of a long chain of unrelated, seemingly innocuous decisions, malfunctions, mistakes and external factors. Remove any single link (or even change their sequence) and you have an on time arrival. Miles O’Brien Uplinks, June 19, 2009. trueslant.com/milesobrien/2009/06/10the-paradox-of-simplicity/.

 In the future computer systems will have an ever increasing role in healthcare decision making and treatment as the incorporation of artificial intelligence applications into electronic medical records provides a whole new platform and paradigm for healthcare delivery. The healthcare industry will eventually face the conundrum of when and under what circumstances a physician will need to regain control over the treatment process. The crash landing of U.S. Airways Flight 1549 in the Hudson River earlier this year underscores some legitimate concerns to keep in mind. That crash also involved an Airbus with a similar air flight control system, which may have unnecessarily shut down the plane’s engines after the bird strike, causing the plane to lose all thrust. There may come a time when we need a doctor with the nerve, experience and professionalism of a Chesley B. “Sully” Sullenberger, III to seize the controls and manage a life threatening emergency.

INTERNET MEDICINE: PART VII – PUBLIC, PROPRIETARY AND PRIVACY TENSIONS IN MEDICAL DEVICES.

The front page of the New York Times today carried a story by Pam Belluck on a hospital’s promotional webcast of Shila Renee Mullins’s brain surgery to extract a malignant tumor, which raised conflicting opinion is about the wisdom, benefit and ethics of the public dissemination of personal medical information, even if consensual, and the public access to dramatic interventional medical procedures. Some hospitals are featuring twittering during operations in order to apprise relatives and others of the progress of thee procedure in real time.

INTERNET MEDICINE: PART VI –CHALLENGES TO DATA SECURITY IN INTERNET MEDICAL DEVICE INFORMATION LINKS.

The growing interoperability between medical devices and electronic medical records gives rise to new opportunities in the transmittal and collection of vital medical data. New vulnerabilities arise as well. Last month, the Internet Storm Center sponsored by SANS (SysAdmin, Audit, Network, Security Institute) warned that the Conflicker worm had infected approximately ten million internet devices including MRIs. SANS is a cooperative research and education organization that since 1989 has specialized in information security technology training and awareness.

The Conflicker worm attacks holes in Windows OS with advanced malware techniques. It is the largest worm infection since the SQL Slammer worm. Many of the infected devices were not designed for internet connectivity. The efficacy of the infection repair is complicated by a FDA regulation which limits the ability to issue an internet “patch” for 90 days, and apparent triumph of law over common sense in crisis with a unique and unanticipated need.