Holland & Hart Healthcare Law Blog

THE PROMISE AND PERIL OF EVIDENCE BASED CLINICAL STANDARDS.

 

A key component of the governments efforts to bend the cost curve for health care is the use of technology and new health delivery structures to introduce “evidence based” clinical standards for the treatment of patients.  Technology will be useful in determining the most clinical effective modalities of treatment and in monitoring the implementation of the guidelines across the spectrum of health car providers. It is an idea that on the surface makes a great deal of sense.  Providers should be held accountable to implement those methods of treatment that have shown themselves to be the most effective and cost efficient in the treatment of chronic disease disease syndromes.

 

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 SINGULARITY IS NEAR: When Humans Transcend Biology. by Ray Kurzweil, Viking Press, 2005.

    Recent developments in brain scanning through technological refinements of SPECT, fMRI and PET scans that monitor water, blood and/or glucose movement in the human brain to observe actual brain functioning as opposed to structure are providing a wealth of new information concerning its organization, complexity and integration.  Ray Kurzweil believes that exponential improvements in the temporal, spatial resolution and bandwidth of the human brain which is doubling each year, will successfully enable us to reverse engineer the human brains principals of operation  in the first half of this century.  This will result in that he calls the “Singularity” where machine based intelligence surpasses that of all humans combined, creating a disruptive transformation in human capability.  This capability he believes will be a billion times more powerful that all of human intelligence today.

Within several decades information based technologies will encompass all human knowledge and proficiency, ultimately including the pattern recognition powers, problem solving skills, and emotional and moral intelligence of the brain itself.

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART II)

    The FDA’s citation to Novartis last week for violations of Federal Law in its use of Facebook “Share” button on its Tasigna website without proper disclosures in the meta tagging, underscore recent concerns about big pharma use of social media and Internet technology to market product. On March 1, 2010, the Center for Digital Democracy an on-line consumer watchdog sent a letter to the FDA requesting that it join the FTC in developing rules for the use of behavioral targeting in on-line marketing and the undertaking of a comprehensive investigation into the use and impact of digital marketing techniques and technologies.

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?

    

HOSPITAL/PHYSICIAN INTEGRATION: CAN THEY GET IT RIGHT THIS TIME?

    Healthcare is one of the trendiest industries in the nation. It is always in a state of flux. During the advent of the deep push into managed care in the 90s there was a feeding frenzy of hospitals trying to gobble up physician primary care practices to control the “gatekeepers” and provide hospital leverage with insurance companies. Hospitals paid huge sums to acquire physician practices before competitors beat them to it.

    

PROVIDER INTEGRATION AND THE ADVENT OF ACCOUNTABLE CARE ORGANIZATIONS (“ACOs”)

    Can financial incentives and physician practice structures be enlisted o enhance the quality and reduce the cost of healthcare?  Health Care Reform supporters believe they can and the new Patient Protection and Affordable Care Act ("PPACA")  signed into law by the President recently,  provides incentives for the development of ACOs for Medicare patients. ACOs have been described as HMO’s on steroids, but many wonder whether they will meet the same fate as the managed care systems of the past that focused on blind leveraged cost reductions and favorable beneficiary selection to achieve profits.

    

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.

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.

PERSONAL MEDICAL RECORDS (“PHR”): PROMISE AND PITFALL

 Hospitals, Physicians and other health care providers continue to struggle with the cost, interoperability, access and security issues related to adoption of Electronic Health Records (“EHR”). The Obama administration is very much behind the development of EHR for its anticipated quality improvement and cost reduction benefits. Healthcare providers are very touch about their medical records control and are somewhat wary of the easy portability of records in digital format.  There is a lot of inertia among patients who are reluctant to change physicians to new ones who are not aware of their history and do not have direct access to their charts.  Those charts have an economic value to the providers who own them.