STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DR. VICTOR J. BILOTTA and )

DR. LAWRENCE BLUMEN, )

)

Petitioner, )

)

vs. ) CASE NO. 83-3512

)

DEPARTMENT OF LABOR AND ) EMPLOYMENT SECURITY, DIVISION OF ) WORKERS' COMPENSATION, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, an administrative hearing was held before Diane D. Tremor, Hearing Officer with the Division of Administrative Hearings, on January 24, 1984, in Orlando, Florida. The issue for determination in this proceeding is whether thermographic medical services rendered by the petitioners to seven patients were "medically necessary" within the meaning of Section 440.13(1)(c), Florida Statutes (1983).

APPEARANCES

For Petitioner: Kendrick Tucker, Esquire

Akerman, Senterfitt & Eidson Post Office Box 1794 Tallahassee, Florida 32302

For Respondent: Michael J. Rudicell, Esquire

Suite 117, Montgomery Building 2562 Executive Center Circle, East Tallahassee, Florida 32301

INTRODUCTION

In support of their position that thermographic medical services are reimbursable under the Workers' Compensation law, petitioners presented the testimony of Dr. Victor J. Bilotta, accepted as an expert in the practice of thermography and orthopedic surgery; Dr. Charles Emanuel Wexler, accepted as an expert in thermography for nerve irritation and diagnostic radiology; Dr.

Margaret Abernathy, accepted as an expert in neurology and thermography; and Dr. Joseph V. Uricchio, accepted as an expert in thermography for nerve irritation and orthopedic surgery. Petitioners' Exhibits 1 through 17 were received into evidence. The exhibits included the deposition testimony of Dr. Ashley Kaye, accepted as an expert in radiology and thermography; Dr. Ronald Weber, accepted as an expert in neurology and thermography; Dr. Joseph Gelety, accepted as an expert in neurosurgery and thermography; Dr. Jacob Green, a neurologist; and Dr. Sumio Uematsu, accepted as an expert in neurosurgery and thermography.

By way of depositions marked as respondent's Exhibits A through C, respondent presented the testimony of Dr. Benjamin A. Johnson, the former Medical Director of the respondent Division of Workers' Compensation; Dr. Elwin Neal, a practicing orthopedic surgeon; and Dr. Peritz Scheinberg, the Chairman of the Department of Neurology at the University of Miami School of Medicine.

The original petition requesting an administrative hearing pursuant to Section 120.57, Florida Statutes, named the patients' insurance carriers as parties respondent to this proceeding. None of the insurance companies made an appearance at the hearing. Inasmuch as the real dispute in this proceeding arises from the agency's interpretation of "medically necessary" within the meaning of Chapter 440, with regard to thermographic services, it is concluded that the insurance companies are not necessary parties to this proceeding either in terms of jurisdiction or in terms of a final resolution of the issues.

Subsequent to the hearing, the parties submitted proposed findings of fact and proposed conclusions of law. To the extent that the parties' findings of fact are not incorporated in this Recommended Order, they are rejected as being either not supported by competent substantial evidence adduced at the hearing, irrelevant or immaterial to the issues in dispute or as constituting legal argument as opposed to findings of fact.

FINDINGS OF FACT

Based upon the oral and documentary evidence adduced at the hearing, as well as the stipulation of facts filed as part of the prehearing stipulation, the following relevant facts are found:

1. Petitioners are orthopedic surgeons practicing in Seminole County.

   They rendered medical services in the nature of a thermogram and a thermographic diagnosis to seven patients who were suspected to be suffering from nerve irritation. Each of the patients complained of either neck or lower back pain with extremity radiation, and had not responded to earlier conservative treatment. The thermograms were a part of the diagnostic studies undertaken by petitioners to treat these patients. These seven patients, who were employees of various employers, were Efrian Toledo, Esther McCoy, Dale Long, Itheria Creech, Jacob A Boone, Glenn McNeely and Orville A. Reiley. The bills for these patients were submitted to the employers' insurance carriers under the Workers' Compensation law. The carriers denied payment for the thermographic services because the respondent Department of Labor had previously ruled by way of a Declaratory Statement dated August 15, 1983, that thermography or thermograms were not a reimbursable medical expense within the meaning of Chapter 440.13, Florida Statutes.

   
   

2. The parties have stipulated that the thermographic medical services received by the seven patients were consistent with the location of the service, were consistent with the level of care provided and were reasonably safe.

   
   

3. Nerve irritation is principally manifested by pain which radiates to an extremity. If a nerve becomes irritated or compressed, there is a change that occurs in the blood supply to this nerve. This change can cause a blood vessel to either dilate or constrict, and this causes a localized change in skin temperature. The nerve irritation results in a change in the blood flow and that change either increases or decreases the amount of heat emanation. Since nerves follow dermatomal skin patterns, akin to a road map, irritation of a nerve is exemplified by a change in skin temperature. The main physiological principle upon which thermography is based is that the infrared energy radiating

   from the bodies' skin surface will vary according to the amount of blood supply below the skin's surface. This scientific principle is valid.

   
   

4. Thermography is the study of infrared patterns emitted by the body. A thermogram is a graphic representation of the heat emitted by a region of the body. The body is known to be symmetrical, and a comparison between comparable body sections can be made to determine if symmetry exists. If there is no localized problem, a symmetrical pattern of heat emission will be presented. Changes or variances in skin temperature, which can be measured and depicted by a thermogram, are an indication of nerve dysfunction. Thermograms are performed under controlled conditions so that extraneous causes of variations in skin temperature may be eliminated. The temperature and humidity of the room is controlled, the patient is given instructions with respect to the intake of hot or cold liquids, medication, nicotine, etc. prior to the examination and a technician is present in the examination room during the procedure. Generally, two or more separate exams, fifteen to twenty minutes apart, are administered to ensure reliability. The procedure is safe, non-invasive and is done on an out- patient basis.

   
   

5. The physicians who testified on behalf of the petitioners at the hearing, who were orthopedists, neurologists and radiologists, all practice thermography for the diagnosis and treatment of patients with nerve irritation, and not for research or experimental purposes. These physicians also receive referrals for thermographic services from other physicians in their area, and are aware of other doctors who practice thermography for nerve irritation. Dr. Bilotta's medical group has utilized thermographic services for the diagnosis and treatment of 198 patients suspected of nerve irritation. A large hospital in Orlando has a thermographic unit. Dr. Uricchio, an orthopedic surgeon from Winter Park, has provided thermographic medical services for some 750 patients, many of whom had been referred to him by 48 area physicians who practice as orthopedic surgeons, neurologists, neurosurgeons and family practitioners. Dr. Uricchio also gives lectures on the subject of thermography at medical meetings where continuing medical education (CME) credits can be obtained. Dr. Ashley Kaye, a radiologist in the Broward County area, utilizes thermography in a clinical practice just as he would utilize other imaging modalities, such as x- ray, CT scans (computerized tomography) and myelography. He and his associates perform thermogram interpretations for six orthopedic surgeons in the Ft. Lauderdale area. He is aware of eighteen other doctors in Broward County who practice thermography. Dr. Ronald Weber, a neurologist in Hollywood, has provided thermographic services to 195 patients and receives referrals from about ten other area physicians. In the past twelve to fifteen months, Dr. Joseph Gelety, a neurosurgeon in Ft. Lauderdale, and his associates have performed from 1200 to 1400 thermograms for approximately 900 patients. He receives referrals for thermographic services from about a dozen doctors from Broward, Dade and Palm Beach Counties. Dr. Jacob Green, a neurologist in Jacksonville, has provided thermographic services to approximately 165 patients and receives referrals for such services from twelve physicians in the Jacksonville area. Dr. Green also teaches thermography to residents from the University of Florida School of Medicine. The Florida Society of Neurology has approved thermography for CME credits.

   
   

6. Thermography for nerve injuries is practiced at Johns Hopkins University Hospital in Baltimore, Maryland, for clinical patient purposes. Between July 1, 1982 through June 30, 1983, Dr. Sumio Uematsu, who teaches and practices at Johns Hopkins and is board certified in neurosurgery, electromyography and electrodiagnosis, performed thermographic services for 558 patients. Some 313 patients received thermographic examinations between July 1,

   1983 and January 6, 1984. Approximately 70 percent of Dr. Uematsu's patients are referred from other doctors at Johns Hopkins Hospital and the remaining 30 percent come from doctors in the Washington, D.C. - Baltimore area.

   
   

7. Dr. Margaret Abernathy, a neurologist who teaches and practices at Georgetown University Hospital in Washington, D.C., has provided, since 1978, thermographic medical services for some 6,000 to 8,000 patients suspected of nerve irritation problems. She utilizes thermography as a routine clinical diagnostic test, just as she would utilize a myelogram, an electromylogram (EMG) or a CT scan. Dr. Abernathy teaches thermography at Georgetown University Medical School, which has an established Fellowship in thermography. She also teaches thermography for nerve irritation to other physicians throughout the United States. She is aware of at least 22 university hospitals where thermography is being practiced on a daily basis.

   
   

8. Dr. Charles Emanuel Wexler, a board certified radiologist who practices in California, provides thermographic diagnosis for some 1,000 patients a year who have suspected nerve irritation. This type of diagnosis is utilized by him as a clinical medical tool and not as an experimental, investigative or research tool. Dr. Wexler teaches thermography at the UCLA Medical School, and lectures extensively both nationally and internationally on the subject of nerve irritation thermography. He conducts training courses for physicians and technicians on the practice of thermography for nerve irritation. These two-day seminars, for which the student is expected to have done several weeks of preparatory study, have been attended by several hundreds of physicians from all over the country. These physicians are typically orthopedists, neurologists, radiologists, psychiatrists, general practitioners and surgeons.

   
   

9. The American Academy of Thermology has approximately 300 members. There are 27 physician members from Florida. As of this year, in order to earn active status, completion of a certification examination is required. A physician may become board certified in thermology by passing the exam, having been involved in the active practice of thermology for no less than two years and having earned no less than 50 hours in continuing medical education in thermology courses sponsored by the Academy.

   
   

10. There is a new organization known as the Florida Academy of Clinical Thermography which has approximately 20 members comprised of orthopedic surgeons, radiologists and neurologists. It is reviewing the training and background of physicians in thermography and is concerned with quality control in the sense that thermography be performed in accordance with accepted clinical standards. The Florida Academy has approved the development of a technologist organization, which will have a written set of standards and an examination.

    
    

11. The typical charge for a thermographic examination is somewhere in the neighborhood of $350.00 to $450.00. This is less expensive than a CT scan or a myelogram and the procedure does not require hospitalization. A negative thermogram -- one which illustrates symmetry in a dermatomal pattern -- excludes the presence of nerve irritation and often leads to the conclusion that no further diagnostic testing or procedures are warranted. A thermogram is useful in detecting malingerers, and also avoids the use of more expensive diagnostic modalities. A positive thermogram -- one showing asymmetry -- may or may not lead to further methods of testing. While the thermogram does not supplant or eliminate the other diagnostic tools, it provides a distinct function and information not available from other methods. It gives information in the physiological arena of sensory nerves which no other procedure can duplicate.

    It is the most sensitive indicator of nerve irritation. The CT scan and

    myelogram are anatomical tests and may reveal why a nerve is irritated. In other words, the thermogram documents nerve fiber irritation but does not reveal its cause. In order to determine the underlying etiological cause of the irritation, and render a determination as to whether surgery is warranted, other tests, such as a CT scan or myelogram, are required. The thermogram is thus complimentary to either the CT scan or the myelogram.

    
    

12. As a diagnostic tool, the thermogram is more accurate than the myelogram and compares favorably with the CT scan. Studies have shown that the thermogram for detection of nerve irritation is between 91 percent and 93 percent accurate, the CT scan is approximately 90 percent accurate and the myelogram is 84 percent or 85 percent accurate. The myelogram will only be positive for an anatomically visible abnormality, such as disc herniation, which may take weeks to become apparent. The thermogram is almost instantly positive when nerve irritation is present.

    
    

13. There are some uses of thermography which are still in an experimental stage. These would include the use of thermograms for detecting skin mole malignancy and the location of the placenta. The use of thermography for nerve irritation appears to be the most common and widely accepted use, and the practice of thermology for this purpose appears to be emerging as an area of specialty or subspecialty.

    
    

14. Thermography for musculoskeletal injury, which includes nerve irritation, is a reimbursable medical expense under the Medicare program. Such thermography has been determined by the U.S. Department of Health, Education and Welfare to be "beyond the experimental stage." At least one Florida court has rejected the contention that thermography is simply "an experimental diagnostic test with little or no proven clinical value," and instead found it to be "reasonable and necessary" and thus compensable under the Florida Motor Vehicle No-Fault Law. Flowers v. State Farm Mutual Automobile Insurance Company, Cty. Ct., Orange Cty., Case No. CO-83-2226 (January 18, 1984).

    
    

15. Thermography is not a universally accepted procedure in the medical community at this time. The three physicians who testified on behalf of the respondent -- a neurologist, an orthopedic surgeon and a pediatric allergist -- were of the opinion that thermography was not widely accepted by the medical community, was still in the investigative or experimental stage and lacked a scientific basis. These three physicians had never performed or even observed a thermographic examination, nor were they familiar with thermographic equipment or the evolution thereof. They had not attended seminars or CME courses related to thermography. Their review of the literature regarding thermography for nerve irritation was not extensive. Dr. Johnson, who investigated the use and acceptance of thermography for the Division of Workers' Compensation, appears to have based his opinions largely upon discussions with several neurologists and orthopedists who have chosen not to utilize thermographic services. He contacted no thermographic practitioner or physician who made referrals for such services on the basis that he "knew what they would say." This lack of personal experience or knowledge regarding the practice of thermography leads the undersigned to place little weight upon the opinion testimony of Drs. Johnson, Scheinberg and Neal regarding the scientific principle underlying the practice of thermography, the degree of its acceptance among the practicing peer group and its experimental, as opposed to clinical, usage.

    CONCLUSIONS OF LAW

    
    

16. Florida's Workers' Compensation Law obligates employers to provide injured employees "such medically necessary remedial treatment, care and attendance" as required by the nature of the work-related injury. Section 440.13(2), Florida Statutes. As pertinent to the issues in this case, "medically necessary" is defined as

    
    

    any service or supply used to identify or treat an illness or injury which is appropriate to the patient's diagnosis, consistent with the location of service and with the level of care provided.

    The service should be widely accepted by the practicing peer group, should be based on scientific criteria, and should be determined to be reasonably safe. The service may not be of an experimental, investigative, or research nature, except in those instances in which prior approval of the Division has been obtained. . . Section 440.13(1)(c), Florida Statutes (1983).

    
    

    The parties have stipulated that the rendition of thermographic services to the seven patients treated by the petitioners was reasonably safe and consistent with the location of service and the level of care provided.

    
    

17. The seven patients complained of pain of a nature suggesting nerve irritation, and had not responded to conservative treatment. It is thus concluded, and no evidence was submitted in opposition to this conclusion, that the provision of thermographic services to these seven patients was appropriate to their diagnosis and condition.

    
    

18. The remaining requirements for a service to be deemed "medically necessary" thus form the three issues in dispute in this proceeding; to wit:

    Are thermographic services

    
    

    1. widely accepted by the practicing peer group,

    2. based on scientific criteria, and

    3. not of an experimental, investigative or research nature?

       
       

       Based upon the evidence adduced at the hearing, it is concluded that thermographic services fully comply with the definition of "medically necessary" within the meaning of Section 440.13(1)(c), Florida Statutes.

       
       

19. The statute does not require that a service, in order to qualify as "medically necessary," be universally accepted by the entire medical community, or even by those specialists involved in disciplines which might typically utilize the service. Rather, the requirement is that the service should be widely accepted by the practicing peer group. It appears from the testimony that thermography itself is becoming a recognized specialty or subspecialty in the practice of medicine and that those who practice thermography are best able to determine its reliability and acceptance. The evidence demonstrates that thermography for suspected nerve irritation is a highly useful and reliable medical procedure and that its usage among orthopedists, neurologists, surgeons

    and radiologists is becoming more prevalent. The fact that some physicians, particularly those who have not chosen to educate themselves in the procedure, may, at this point in time, not utilize the procedure does not negate the fact that thermographic examinations and diagnosis are being utilized for clinical purposes by a great many physicians throughout Florida and the United States. The procedure is also being clinically performed and taught at a number of leading medical centers throughout the country. The evidence establishes that thermography for nerve irritation is widely accepted by that group of physicians qualified by training and experience to practice it in some form. As indicated in the Findings of Fact above, the evidence amply illustrates that thermography is widely accepted by doctors who practice in the treatment and diagnosis of suspected nerve irritation, particularly orthopedists, neurologists, radiologists and some general practitioners.

    
    

20. In order to be "medically necessary," a service used to identify or treat an illness or injury must not be of an experimental, investigative or research nature. While there are some usages of thermograms which would qualify as being of an experimental nature, the evidence presented by the petitioners amply established that thermographic services for nerve irritation is practiced, both in Florida and throughout the country, on a clinical basis and is beyond the experimental, investigative or research stage. Its reliability to detect the presence of nerve irritation has been demonstrated to equal or exceed other widely accepted diagnostic tools currently utilized on a clinical basis. While the thermogram may not provide all the answers with respect to a source of pain, it is the most sensitive indicator of nerve irritation and thus is a rational, valuable and necessary tool in the clinical treatment of patients with pains in the back, neck and radiating to the extremities. In addition, it is a harmless, painless, less time-consuming and the least expensive method of providing objective evidence of nerve irritation.

    
    

21. The petitioners have demonstrated the soundness and validity of the scientific principle upon which thermography for nerve irritation is based -- that infrared energy radiating from the skin surface varies depending upon the amount of vascular supply in and below the skin surface. Thermography is able to translate those invisible infrared or heat energy emission patterns radiating from the body into a visible photographic form. As a medical procedure for diagnosing suspected nerve injury, thermography is unique, reliable and not repetitive to other diagnostic tests. Thermography measures physiology or how a nerve functions whereas the CT scan and myelogram measure anatomy or the structure of the nerve. The wide practice and demonstrated reliability of thermography confirms the validity of the scientific principle upon which it is based.

RECOMMENDED ORDER

Based on the findings of fact and conclusions of law recited herein, it is RECOMMENDED that a Final Order be entered by the Department of Labor approving thermographic services for suspected nerve irritation as medically necessary within the meaning of section 440.13, Florida Statutes, and that the medical services furnished for the seven patients treated by petitioners be reimbursed by the carriers or self-insurers.

Respectfully submitted and entered this 1st day of June, 1984, in Tallahassee, Florida.

DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32301

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 1st day of June, 1984.

COPIES FURNISHED:

Kendrick Tucker, Esquire Akerman, Senterfitt & Eidson

P. O. Box 1794 Tallahassee, Florida 32302

Michael J. Rudicell, Esquire Suite 117, Montgomery Building

2562 Executive Center Circle, East Tallahassee, Florida 32301

Wallace E. Orr, Secretary

Department of Labor & Employment Security Suite 206, Berkeley Building

2590 Executive Center Circle, East Tallahassee, Florida 32301

Docket for Case No: 83-003512

Orders for Case No: 83-003512