The insurance industry and government attacked high resolution, dynamic, digital infrared imaging

At the behest of the property and casualty insurance industry who were over-reacting to the use of liquid crystal thermography by persohjnal injury lawyers attempting to show “pictures of pain” to inflate daamage claims in soft-tissue injury cases, in 1990, the Health Financing Administration (HCFA) of the United States Department of Health & Human Services (DHHS) proposed to terminate Medicare coverage for high resolution infrared digital thermal imaging technology in the diagnosis and treatment of musculo-skeletal and neuromuscular disorders associated with trauma or disease.

This HCFA action was immediately echoed by State agencies, third party payers, and insurance carriers throughout the nation.

The Texas Chiropractic Association litigation

The Texas Chiropractic Association, a statewide professional society, retained Yannacone as their counsel and filed a class action against this outrage in the United States District Court for the Eastern District of New York challenging the scientifically shoddy report from the Office of Health Technology Assessment (OHTA) upon which the HCFA decision was based and more significantly seeking to protect the freedom and sanctity of the relationship between health care professionals and their patients, particularly the victims of accidental injuries and occupational disease.

The Confidential Litigation Memorandum

To: Health Care Professionals throughout the United States
FROM: Victor John Yannacone, jr., Attorney
DATE: 21 February 1991
re: HCFA interference with diagnosis and treatment

The complaint clearly details the inaccurate and unscientific methods HCFA used to evaluate digital thermal imaging technology.

Modern high resolution infrared digital thermal imaging technology is one of the most important non-invasive techniques ever made available to health care practitioners to aid them in the differential diagnosis of conditions affecting the autonomic nervous system and to permit the treatment of such conditions to be monitored in an objective and scientifically reproducible fashion.

Rather than respond on the merits to the issues raised in the complaint, the United States Department of Health & Human Services through the office of the United States Attorney has chosen to challenge the propriety of health care practitioners advancing the interests of their patients.

The Washington health care bureaucracy supported by our tax dollars claims that they, a group of unaccountable faceless bureaucrats in Washington and their nameless advisors together with the cost accountants of the third-party payers, insurance carriers, and other representatives of the health care insurance industry can limit the means available to health care providers in the care and treatment of their patients. These bureaucrats and their comrades from the insurance industry do not share your responsibility for the care and treatment of your patients, much less your liability if it turns out that one of their rulings leads to further illness, increased disability, or even, God forbid, the death of one of your patients.

Unless we succeed in this litigation the healing arts will be directed from the office of some cost accountant in Washington or from the memos of the chief financial officer at some insurance company rather than by the health care professionals like yourselves in whose care the patients have placed their well­ being and even their very lives.

The stakes in this litigation are considerably greater than just whether high resolution infrared digital thermal technology should be available to the health care practitioner as a service which may be billed to third party payers, insurance carriers and the government. The real issue in this litigation is the fundamental question of who shall speak for the patients, those who provide their health care directly, all of you who have earned the right to add the initials MD, DC, DO, DPM, DDS,… and who are devoting your lives to the care and treatment of those suffering the effects of trauma or disease or a small group of cost-containment cabal lurking in the dim, dark recesses of the bureaucratic bowels of our nation’s capital.

Organized medicine has sold you out

Because the American Academy of Orthopaedic Surgeons (AAOS), The American Academy of Neurology (AAN), and the American Society of Radiologists (ASR) have declared their direct organizational opposition to clinical thermography, the legal burden has shifted to you health care practitioners who wish to continue to use thermography in clinical practice.

You must establish by a fair preponderance of the substantial credible scientific and medical evidence that clinical thermography is not only safe but effective and of value in diagnosis and treatment of the conditions for which you wish to use it.

The OHTA and the HCFA are correct in their argument that there are no clinical studies documenting the effectiveness and utility of thermography, so long as we define “clinical studies” in the conventional sense of those studies routinely performed in the medical field with controls and normals and blind trials of drugs and therapeutic intervention.

Our burden is to establish that such conventional studies are unnecessary because they are inappropriate in the evaluation of devices which measure physiological effects. We must show by a fair preponderance of the credible scientific evidence that there are more appropriate methods of evaluating clinical thermography.

In order to sustain the burden imposed upon those who would continue to use clinical thermography in their professional practices, we must present the court with a complete compilation (abstracts together with copies of the full papers) of all the published literature on clinical thermography together with the appropriate physiological literature on which the technology is based. This is an awesome task which should have been done over the years at some academic institution. It has never been done and the few studies which purport to be “Reviews” of the “literature” are inadequate at best and no better than the “Handlesman Report” commissioned by OHTA.

Unfortunately, the process of compiling the information is expensive. * * * There is the even more intractable problem of the time necessary to complete the job. Hopefully the court’s trial schedule will afford us that time. When all of the information has been compiled, it must be made accessible in some kind of full text, key-word-in-context (KWIC) retrievable system which can be used in real time in the courtroom.
The job, once done, however, need never been repeated. The material and the data base management system can be made available to practitioners on optical disks at reasonable cost so that eventually the cost of compiling the data base and producing the data base management system can be recovered over time.

Assuming we start immediately, scanning the documents and retrieving those that are available in existing electronic data bases will require ‘round-the-clock work by staff and temporary help.

After the papers have been compiled in machine readable form, the abstracts assembled, and the index developed, there is still the problem of combining data in an annotated meaningful fashion and producing a critical review similar to, but more scientifically objective than, the Handlesman Report . This is not a trivial task. We must establish a committee of experts familiar with the literature to work on developing this Review during the month of April for completion no later than 1 May 1991. The Committee should include all those who have critically evaluated the Handlesman Report and presented their own evidence to the HCFA. We will discuss that at length in a conference call very shortly. * * *

Validation

Clinical Thermography must be validated if we are to have any chance at a judicial review of the HCFA proposed regulation before it becomes final.

The technology that we intend to validate will be presented to the court as High Resolution Infrared Tomographic Digital Thermal Imaging . This appellation seems to be the most comprehensive statement we can make about the kind of technology that it is possible to validate by non-parametric methods.

As I explained this past weekend in Dallas, I intend to validate modern high resolution Infrared Tomographic Digital Thermal Imaging technology by application of non­parametric statistical analysis to existing high resolution infrared digital thermal imaging data.
I intend to call upon actuaries to conduct the ultimate validation for presentation to the court, after we have conducted preliminary studies utilizing existing state of the art technology in the hands of mathematically sophisticated, statistically learned individuals who will give us some reasonable assurance that our theoretical investigations are essentially correct and capable of practical demonstration .

Since non-parametric methods are essentially auto-correlative or “self-correlating,” there is no need for “controls” in the conventional clinical study sense of that concept. The controls are found within the data set itself. The only assumption about the data is that every individual human being is a dynamic physiological system the state of which changes over even short periods of time and in response to both exogenous and endogenous stimuli. The only constancy we will assume in human physiology is the behavior of the individual nerve fiber as a very special kind of electrical transmission line characterized by many of the aspects of wave guides, microwave transmission lines, semiconductor integrated circuits, and ordinary household wiring.

With only these limited and well-accepted hypotheses, together with the well­ documented physiological evidence establishing that thermal regulation of the skin is controlled by the nervous system through signals conveyed along individual nerve fibers, we will subject the thermal information contained in a digital thermal image together with the information about the spatial location and time of the source of the thermal emission to modern non-parametric statistical analysis.

Such statistical analysis will determine with a reasonable degree of mathematical certainty whether any symmetries exist among the individual points of thermal/spatial/ temporal data in the data set or collection of thermal data assembled on the patient at a particular time.
Should thermal symmetries appear and statistical associations identify statistically significant coherent areas of skin surface with an independent statistical identity, then the theoretical basis for the existence of thermatomes and the existence of axes of symmetry between, among and within thermatomes will have been established.

At that point the statistical significance of differences in temperature across those axes of symmetry can be considered with conventional parametric statistics and reflect meaningful physiological information about the patient being studied irrespective of any other patient or any assumed or presumed “normal” states.

It is this non-parametric statistical process that eliminates the need for cohorts and experimental clinical controls and makes each patient their own control and some part of each patient the “normal.”

Preliminary theoretical considerations lead us to believe that such symmetries exist and can be demonstrated. The next step is to actually demonstrate them, and when we have demonstrated them in a preliminary fashion, have the demonstrations validated in a precise and formal way suitable for presentation to the court and to the academic community. Both events will occur contemporaneously and at that point the scientifically acceptable mathematical and physiological basis for high resolution infrared tomographic digital thermal imaging will be established so that clinical studies will have general meaning other than as clinical anecdotes.

It is our intention to take a modern thermographic imaging device, and an earlier unit from each manufacturer willing to cooperate with the validation and evaluate the same patient and subject the data to the same rigorous statistical examination. This will serve the dual purpose of validating the new technology and vindicating the existing digital thermal imaging technology.

You health care providers concerned with clinical thermography will contribute to establishment of the National Registry of Digital Thermal Imaging which will serve as the central clearing house for medical thermology. This institution will continue to maintain the software for statistically interpreting thermal images from whatever system provides the image.

The National Registry of Digital Thermal Imaging will process information received from thermographers throughout the world and maintain a library of thermographic images and information which will be regularly analyzed using the most sophisticated modem methods statistical methods. Eventually individual practitioners may compare the thermal information obtained from their patients with thermal information obtained from patients throughout the world and utilize the clinical information and information from other tests associated with those thermal images to guide their own clinical efforts and support their own clinical judgment.

It appears that after validation, high resolution infrared tomographic digital thermal imaging may become the basic initial screening technology in almost all cases of soft tissue injury and for a variety of conditions that are or may be associated with the sympathetic nervous system. This safe and non-invasive technology can save the health care consumer and their insurers a great deal of money and avoid exposing the victims of industrial accidents, occupational disease, and motor vehicle trauma to the additional risks associated with a variety of diagnostic tests that may become unnecessary as high resolution dynamic digital infrared thermal imaging becomes even more sophisticated.