Singularity Health Law Blog

CALIFORNIA STREAMING: TELEHEALTH ADVANCEMENT ACT

The often contentious California legislature passed the Telehealth Advancement Act of 2011 without opposition achieving broad advances in the expansion of medical services in rural areas of the state. It expands the Telehealth Development Act of 1996 to all licensed health care providers and proscribes insurance plan requirements for an in person relationship to obtain consent. Consent can be verbal and must be recorded. Failure to obtain consent is deemed "unprofessional conduct."

 

The new Act provides for advancing hospital credential approval of distant consultants and specifies that insurance companies may not place limits on settings where telehealth services may be provided. The Act does state that it is not to be used to mandate telehealth service in settings that insurance companies deem inappropriate.

 

The Legislature in enacting the law sought to dispel any doubt about the future of telemedicine in California.

 

It is the intent of the Legislature to recognize the practice of telehealth as a legitimate means by which an individual may receive health care services from a health care provider without in-person contact with the healthcare provider. 

 

CONCIERGE MEDICINE | MEDICARE OVERLAP TRAP

According to a GAO report in 2005 approximately seventy five percent of those physicians providing concierge medicine services do not opt out of Medicare, but provide some services either as a participating or non-participating physician. Those physicians must be very careful to assure that they do not charge concierge customers for any service that might be otherwise covered by Medicare which can create a potential claim for over-billing for medicare services in violation of the False Claims Act.

MEDICARE PROVIDERS | THE “OPT OUT” OPTION.

There is a fair amount of confusion afoot concerning the obligation or not of physicians to accept Medicare patients.  There is no requirement that any physician accept Medicare patients or refrain from limiting the number of Medicare patients accepted into the physician’s practice. There are circumstances when it may be in the best interest of a physician to “opt out” of Medicare.  The growth of concierge medicine  in some respects makes it safer for physicians to “opt out” of Medicare in order to avoid stepping afoul of the Medicare fee limitations by charging for services that might be construed by CMS or the OIG as being extra contractual charges which might implicate the federal false claim statute. According to 2005, General Accounting Office Survey of providers of concierge medicine, only about 25% of them had opted out and were practicing on the cash only high wire without the Medicare safety net.

 

OBAMA BLUE BUTTON INITIATIVE PUSHES PHR DOWNLOAD PROGRAMS

 Recognizing the critical health care need for accurate historic  patient health records, the Obama administration has developed what it calls a “Blue Button” download initiative at the Department of Veteran Affairs, CMS and HHS. These are all programs that permit patients to go on-line and download their own medical records that they can share with their providers, caregivers and trusted others.  Some of these programs are now operational.  In the lead is the VA ( www.myhealth.va.gov ) where approximately 60,000 veterans have already accessed their records.  Medicare recipients can also access their records now at www.mymedicare.gov . Only about 5,600 have done so. There are about 47 million medicare recipients and 1 million veterans.

Regulatory Ricochet - a Peril of Multi-State Licensure For Physicians.

The rise of the internet, telemedicine and on-line communication technology have led to a greater federal government interest in improving the cost and quality of medicine by promoting the cost-effective patient access to consulting or even treating physicians across state lines. Earlier many states had loose regulations permitting limited consultation by in-state physicians with out of state physicians. With the proliferation of communications technology many, if not most, states have tightened up their vigilance and regulatory requirements for out of state physicians consulting on or treating patients located in the state. Most states have adopted standards to deal with and in varying degrees permit telemedicine. They provide various forms of limited licensure and of course require the payment of fees and the submission of the physician to the jurisdiction and authority of the state medical board which regulates and imposes discipline on the practice of medicine.

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 2.0: Insurance Coverage and Broadband Expansion For Telemedicine Services.

Whether or not an insurance company will provide coverage for telemedicine services or not is generally controlled by the company’s interpretation of its policies.  Many insurance companies do voluntarily provide telemedicine coverage.  Some insurance policies require “face to face” provision of services or specifically exclude telemedicine coverage.  In most states the issue of telemedicine coverage is left to the discretion of the insurance companies in their plan designs.

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 “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.