STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DOUGLAS PHILLIPS, )

)

Petitioner, )

)

vs. ) CASE NO. 94-762

)

DIVISION OF WORKERS' )

COMPENSATION, )

)

Respondent. )

and )

) BOCA RATON COMMUNITY HOSPITAL ) and CIGNA, )

)

Intervenors. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, Susan B. Kirkland, held a formal hearing in this case on July 20, 1994 and April 24, 1995 in West Palm Beach, Florida.

APPEARANCES

For Petitioner: Robert R. Johnson, Esquire

Wagner, Nugent, Johnson & McAfee, P.A. 1818 North Australian Avenue

Suite 450, Commerce Point

West Palm Beach, Florida 33402

For Respondent: Michael G. Moore, Senior Attorney

Department of Labor and Employment Security

2012 Capital Circle, Southeast Suite 307, Hartman Building Tallahassee, Florida 32399-2189

For Intervenors: Nancy Lehman, Esquire

Neil Hayes, P.A.

224 Datura Street, Suite 2601 West Palm Beach, Florida 33401

STATEMENT OF THE ISSUES

Whether Petitioner's proposed treatment, fluoroscopic radiofrequency thermoneurolysis, is experimental.

PRELIMINARY STATEMENT

By letter dated November 22, 1993, Respondent, the Florida Department of Labor and Employment Security, Division of Workers' Compensation (Division), issued a determination that the procedure, fluoroscopic radiofrequency thermoneurolysis, was experimental and payment would not be made for such a procedure. Petitioner, Dr. Douglas J. Phillips, Jr. (Dr. Phillips) requested an administrative hearing on the determination.

On February 8, 1994, the case was referred to the Division of Administrative Hearings for assignment to a Hearing Officer. The final hearing was scheduled for March 25, 1994. Dr. Phillips requested a continuance and the final hearing was rescheduled for July 20, 1994. On May 2, 1994, Intervenors, Boca Raton Community Hospital (Hospital) and CIGNA filed a Petition to Intervene. The Petition to Intervene was granted. The final hearing commenced on July 20, 1994, but the parties were unable to conclude on that day. The hearing was scheduled to reconvene on November 30, 1994. Intevernor Hospital filed an unopposed Motion for Continuance on November 17, 1994, and the final hearing was rescheduled for April 24, 1995.

At the final hearing, Petitioner testified in his own behalf and called Susan Patricia Cullen as a witness. Petitioner's Exhibits 1 and 2 were admitted in evidence. Respondent called Donna M. Reynolds and Dr. John Roland Westine as its witnesses. Respondent's Exhibits 1-8 were admitted in evidence.

Intervenors did not call any witnesses. Intervenors' Exhibits 1, 4, and 5 were admitted in evidence. Intevenors proffered Intervenors' Exhibit 2.

At the final hearing the parties agreed to file their proposed recommended orders within 30 days of the filing of the transcript. The last volume of the transcript was filed on May 15, 1995. By letter dated June 6, 1995, Petitioner requested an extension of time in which to file proposed recommended orders.

The time for filing proposed recommended orders was extended to June 29, 1995. The parties timely filed their proposed recommended orders. The parties' findings of fact are addressed in the Appendix to this Recommended Order.

FINDINGS OF FACT

1. Petitioner, Douglas J. Phillips, Jr., D.D.S. (Dr. Phillips), is a licensed dentist in the State of Florida.

   
   

2. Sometime in January, 1993, Dr. Phillips proposed using the procedure, fluoroscopic radiofrequency thermoneurolysis to treat a patient. This procedure involves destruction of tissue by the application of high heat, at approximately two hundred degrees Fahrenheit. A probe or cannula (insulated needle) is placed through skin, subcutaneous tissue and muscle to reach into where the tendon or ligament inserts to the bone or to where there is a small nerve root. An electrode goes through the insulated needle. Heat is then applied at approximately two hundred degrees. The treatment causes a small scar on the bone or destroys the nerve. The purpose of the procedure is to treat head and facial pain.

   
   

3. The patient has been diagnosed with the degeneration of the temporomandibular joint on the left side, advanced degenerative osteoarthritis, and fibrous ankylosis with osteroarthritis of the left temporomandibular joint. She experiences head and facial pain. Dr. Phillips had performed fluoroscopic radiofrequency thermoneurolysis on the patient in September, 1991. CIGNA approved and paid for the procedure. The patient experienced relief from the

   pain for almost two years after the procedure was done. The patient is now experiencing pain again, and Dr. Phillips proposes to treat her again with fluoroscopic radiofrequency thermoneurolysis.

   
   

4. By letter dated January 29, 1993, Intervenor CIGNA, informed Dr. Phillips that his request to perform the proposed treatment was not authorized. CIGNA'S basis for denial of approval was that the procedure was experimental and was not recognized by the American Dental Association.

   
   

5. On or about August 27, 1993, Dr. Phillips requested that Respondent, the Department of Labor and Employment Security, Division of Workers' Compensation (Division), review the procedure pursuant to Section 440.13(1)(d), Florida Statutes (1993) and Rule 38F-7.0201, Florida Administrative Code.

   
   

6. On November 22, 1993, the Division issued a determination that fluoroscopic radiofrequency thermoneurolysis was experimental.

   
   

7. Dr. Phillips was taught the proposed procedure eight years ago by Dr. Ernst, a dental practitioner in Alabama. Dr. Phillips spent four days observing Dr. Ernst in Dr. Ernst's office and one week of training in a hospital under the direction of Dr. Ernst. The first procedure performed by Dr. Phillips was two years after his training with Dr. Ernst. Prior to performing the procedure, Dr. Phillips also attended a one hour lecture on the procedure given by another dentist.

   
   

8. No other dentist in Florida practices this procedure. The American Dental Association has not endorsed the procedure. Radiofrequency thermoneurolysis is not on the American Dental Association's list of approved dental therapeutic modalities. It is not taught in any dental school or school of oral surgery. Dr. Phillips is not aware of any mention of the proposed procedure in any dental or oral surgical textbooks. Only four other dentists in the United States practice this procedure.

   
   

9. There is no published written protocol regarding this procedure except for an article written by Dr. Wilk, which consists of a two paragraph treatment of the subject.

   
   

10. Fluoroscopic radiofrequency thermoneurolysis is not listed in the American Dental Association's Current Dental Terminology, nor does the proposed treatment have a code assigned to it.

    
    

11. Donna M. Reynolds is a supervisor of the policy section in the Rehabilitation and Medical Services Unit of the Division. When she received the request from Dr. Phillips to review the proposed procedure, she contacted three consultants for the Division: Dr. Richard Joseph, Dr. Martin Lebowitz and Dr. Davis. She received responses from Drs. Joseph and Lebowitz indicating that they considered the procedure to be experimental. Dr. Davis did not respond to her request.

    
    

12. Dr. Joseph is a board certified oral and maxillofacial surgeon. When asked by the Division to review the proposed treatment, he reviewed all the documentation submitted by the Division, which included the documentation that Dr. Phillips had submitted in support of his request. Dr. Joseph also did a medline search. Medline is a computerized medical library search that is commonly performed by physicians to research or review all of the current medical literature. The medline search of 301,000 articles revealed only two or three articles relating to the use of radiofrequency thermoneurolysis. Dr.

    Joseph also consulted with Dr. Gremillion, the chairman of the Department of Facial Pain at the University of Florida, College of Dentistry. Based on his research, Dr. Joseph opined that the proposed procedure was experimental.

    
    

13. It was Dr. Joseph's opinion that radiofrequency thermoneurolysis was outside the practice parameters in the general practice of dentistry.

    
    

14. Dr. Lebowitz, an oral and maxillofacial surgeon and former co-director of the Facial Pain Clinic at the University of Florida, reviewed the documentation sent by the Division with its request to review the proposed treatment. The documentation included articles which had been supplied by Dr. Phillips to the Division. It was Dr. Lebowitz's opinion that none of the articles submitted by Dr. Phillips were scientifically acceptable based on the lack of blind studies, the quantity of patients being studied, and the lack of studies performed in different locations.

    
    

15. In researching the issue, Dr. Lebowitz contacted Dr. Jim Ruskin, the head of the residency program in the Oral Maxillofacial Surgery Department at the College of Dentistry, University of Florida. Dr. Ruskin is considered a world authority on the management of facial pain. Dr. Lebowitz also spoke with Dr. John Gregg, a Virginia dental practitioner who previously ran the facial pain clinic at Chapel Hill at the University of North Carolina. Additionally, Dr. Lebowitz spoke with Dr. Castellano, an oral and maxillofacial surgeon in Tampa, Florida.

    
    

16. Based on his research, Dr. Lebowitz concluded that radiofrequency thermoneurolysis was experimental.

    
    

17. Dr. John Roland Westine is board certified in oral maxillofacial surgery and is a licensed dentist. He has studied the use of electrical energy in destroying tissue and has used electro-surgical equipment for thirty years. Dr. Westine is familiar with radiofrequency thermoneurolysis. Prior to the final hearing, he had reviewed the records of forty patients who had been treated with radiofrequency thermoneurolysis. It was his opinion that the proposed procedure was not safe and could cause the following problems: irreparable damage to vision, stroke, motor deficiencies, damage to facial nerves, nerve deficits, sensory deficits, abscess formations and parotid fistulas.

    
    

18. Based on the preponderance of the evidence, Dr. Phillips has not demonstrated that the fluoroscopic radiofrequency thermoneurolysis is widely accepted by the practicing peer group, that the procedure is based on scientific criteria, or that the procedure is reasonably safe. Radiofrequency thermoneurolysis, including fluoroscopic radiofrequency thermoneurolysis, is an experimental procedure.

    
    

    CONCLUSIONS OF LAW

    
    

19. The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of this proceedings. Section 120.57(1), Florida Statutes.

    
    

20. Petitioner has the burden to establish that the proposed treatment is medically necessary. Balino v. Department of Health and Rehabilitative Services, 348 So. 2d 249 (Fla. 1st DCA 1977).

21. Section 440.13(1)(d), Florida Statutes (1993) provides:

    
    

    'Medically necessary' means any service or supply used to identify or treat an illness or injury. . . . 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. The division shall promulgate rules providing for such approval on a case-by- case basis when the procedure is shown to have significant benefits to the recovery and well- being of the patient.

    
    

22. Rule 38F-7.0201, Florida Administrative Code, provides:

    
    

    (2) For the purpose of this chapter, the following definitions apply. . . .

    (b) 'Experimental' describes a service, procedure, drug, equipment or supply, the safety and efficacy of which is not proven. Its safety, reliability, validity and efficacy are being tested in controlled studies which meet scientifically-accepted, rigorous methodological criteria.

    * * *

    (4) Approval will not be granted and payment may not be made for those services, procedures,

    drugs, equipment or supplies which are classified by the Division as experimental.

    * * *

    1. To obtain approval of services, procedures, drugs, or equipment of investigative nature for use in remedial or palliative treatment of a work- related injury:

       1. The health care provider or health care facility proposing the service, procedure, drug, equipment or supply must present to the Division documentation of success in the treatment of similar conditions. The documentation must be based on scientifically accepted criteria and demonstrated by more than one independent investigator.

       2. Following the request for approval the Division will review the request and if it determines that the request may be meritorious, it shall submit the request and documentation for consideration by three expert consultants authorized under Section 440.13(1)(a), Florida Statutes. The request must be approved by two of the consultants for the specific application

    proposed. However, if the documentation supporting the request does not include at least one study conducted by investigators other than the provider

    and facility proposing the service, procedure, equipment or supply, the request shall be submitted to four expert consultants authorized under Section 440.13(1)(a), Florida Statutes, and must be approved by three of the four expert consultants.

    
    

23. Dr. Phillips has failed to establish that fluoroscopic radiofrequency thermoneurolysis is medically necessary. The evidence established that the proposed procedure is experimental and as such it can not be considered medically necessary pursuant to Section 440.13(1)(d), Florida Statutes and Rule 38F-7.0201, Florida Administrative Code, and approval cannot be granted and payment cannot be made for the service.

    
    

24. The proposed procedure is not widely accepted by the practicing peer group. There is no dentist in Florida other than Dr. Phillips who uses the procedure to treat head and facial pain. Based on Dr. Phillips testimony, he is aware of only four other dentists in the United States who are using the procedure.

    
    

25. The articles which Dr. Phillips provided to the Division do not demonstrate that the proposed procedure is based on scientific criteria. The articles do not include blind or controlled studies. Some of the articles are anecdotal, and some refer to a small number of patients.

    
    

26. Based on the expert opinion of Drs. Westine, the procedure is not reasonably safe. The procedure is outside the standard of acceptable care by general dentists.

    
    

27. Dr. Phillips argues that the procedure should not be considered experimental because in a formal review decision relating to a denial of CHAMPUS cost sharing for radiofrequency thermoneurolysis, a Hearing and Appeals Analyst held that the procedure was not experimental based on the Department of Defense guidelines and that the CHAMPUS Policy Manual would be revised to reflect that CHAMPUS benefits would be available for the procedure under certain limited circumstance. However, Dr. Phillips has cited no authority and I have found no authority for the proposition that the Division is bound by a determination of the Department of Defense, Office of Civilian Health and Medical Program of the Uniform Services that the procedure is not experimental for the purpose of CHAMPUS benefits.

    
    

28. Dr. Phillips argues that the Division should have submitted Dr. Phillips' request and documentation to four consultants for review. Whether the Division submitted the documentation to three or four consultants is irrelevant to the issue because the Division received opinions from two of the consultants that the procedure proposed by Dr. Phillips was experimental. Pursuant to Rule 38F-7.0201(7)(a), if the request is reviewed by three consultants, two of the consultants must approve the procedure, and if the procedure is reviewed by four consultants, three must approve the procedure. Thus, under either scenario, the Division would not have approval from the required number of consultants. If the Division had used four consultants, it would not have approval from three experts because two consultants had determined that the procedure was experimental.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered determining that fluoroscopic

radiofrequency thermoneurolysis is experimental and denying approval for the procedure.

DONE AND ENTERED this 29th day of August, 1995, in Tallahassee, Leon County, Florida.

SUSAN B. KIRKLAND

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 29th day of August, 1995.

APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-762

To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact:

Petitioner's Proposed Findings of Fact.

1. Petitioner did not designate which portion of his proposed recommended order contained the proposed findings of fact and which portion contained the proposed conclusions of law; thus, I am unable to address the paragraphs which Petitioner may contend are his proposed findings of fact.

Respondent's Proposed Findings of Fact.

1. Paragraphs 1-5: Accepted in substance.

2. Paragraphs 6-7: Accepted that that is what the statutes and rule say.

3. Paragraph 8: The first sentence is accepted in substance. The second sentence is accepted to the extent that the Division does submit the documentation to consultants. The evidence established that the proposed treatment is not for use in the aid or confirmation of a diagnosis; therefore, the Division would not be required to submit the documentation to four consultants based on Rule 38F-7.0201, F.A.C.

4. Paragraph 9: Accepted in substance.

5. Paragraph 10: Accepted.

6. Paragraph 11: Rejected as unnecessary.

7. Paragraphs 12-15: Accepted in substance.

8. Paragraph 16: Rejected as constituting argument.

Intervenors Proposed Findings of Fact.

1. Paragraphs 1-2: Accepted in substance.

2. Paragraph 3: Rejected as unnecessary detail.

3. Paragraphs 4: Accepted.

4. Paragraph 5: The last sentence is rejected as unnecessary. The remainder is accepted in substance.

5. Paragraph 6: Accepted in substance.

6. Paragraph 7: Rejected as unnecessary detail.

7. Paragraphs 8-9: Accepted to the extent that Dr. Phillips desires to use the proposed treatment. The remainder is rejected as unnecessary.

8. Paragraph 10: Rejected as not supported by the greater weight of the evidence.

9. Paragraph 11: Rejected as unnecessary.

10. Paragraphs 12-15: Accepted in substance.

11. Paragraph 16: Rejected as unnecessary.

12. Paragraph 17: The first sentence is rejected as unnecessary. The second sentence is accepted in substance.

13. Paragraph 18: Accepted in substance.

14. Paragraph 19: The first four sentences are accepted in substance. The remaining is rejected as unnecessary.

15. Paragraphs 20-21: Accepted in substance.

16. Paragraphs 22-31: Rejected as unnecessary.

17. Paragraphs 32-35: Accepted in substance.

18. Paragraph 36: Rejected as unnecessary.

19. Paragraphs 37-39: Accepted in substance.

20. Paragraphs 40-41: Rejected as unnecessary.

COPIES FURNISHED:

Robert R. Johnson, Esquire Post Office Box 3466

West Palm Beach, Florida 33402

Michael Moore, Esquire

Office of the General Counsel

Department of Labor & Employment Security 2012 Capitol Circle Southeast, Suite S-307 Tallahassee, Florida 32399-2189

Nancy Lehman, Esquire Neil J. Hayes, P.A.

224 Datura Street, Suite 601 West Palm Beach, Florida 33401

Douglas L. Jamerson, Secretary Department of Labor and

Employment Security

303 Hartman Building

2012 Capital Circle Southeast Tallahassee, Florida 32399-2152

Edward A. Dion Department of Labor and

Employment Security General Counsel Department of Labor and

Employment Security

303 Hartman Building

2012 Capital Circle Southeast Tallahassee, Florida 32399-2152

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this recommended order. All agencies allow each party at least ten days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.

Docket for Case No: 94-000762

Orders for Case No: 94-000762