STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AMERICAN BOARD OF CHELATION ) THERAPY, )

)

Petitioner, )

)

vs. ) Case No. 96-3173

)

BOARD OF MEDICINE, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, an administrative hearing was held before William A. Buzzett, an Administrative Law Judge with the Division of Administrative Hearings, on November 15, 1996, in Tallahassee, Leon County, Florida.

APPEARANCES

For Petitioner: Gregory D. Seeley, Esquire

Seeley, Savidge & Aussem, Co. L.P.A. 800 Bank One Center

600 Superior Avenue, East Cleveland, Ohio 44114-2655

For Respondent: Allen R. Grossman, Esquire

Department of Legal Affairs The Capitol

Tallahassee, Florida 32399-1050

STATEMENT OF ISSUES

Whether the Respondent properly denied the Petitioner’s request to be a “recognizing agency” within the parameters of Rule 59R-11.001, Florida Administrative Code.

PRELIMINARY STATEMENT

This cause arose on July 17, 1995, when Petitioner, the American Board of Chelation Therapy (ABCT) submitted its petition to the Florida Board of Medicine (Board of Medicine) to be certified as a “Recognizing Agency” within the requirements of Rule 59R-11.001, Florida’s Advertising Rule. In October 1995, the Board of Medicine considered the issue and referred the Petition to its Rules Committee. In March 1996, the Rules Committee recommended that the petition be denied. On April 15, 1996, the Board of Medicine issued an order denying the petition, citing that ABCT failed to establish compliance with the requirements for approval as set forth in Rule 59R-11.001(2)(f), Florida Administrative Code.

On May 17, 1996, ABCT filed a Petition for formal hearing. This cause was later assigned to the undersigned administrative law judge for adjudication. An initial order was issued on July 12, 1996, and the parties filed a Joint Response to the order within the 10-day deadline. Subsequently, a Motion for Continuance of the Hearing was filed and granted. ABCT then filed a Petition Seeking Administrative Determination of the Validity of Rule 59R-11.001(2)(f), Florida Administrative Code, as an invalid exercise of delegated legislative authority. On October 21, 1996, the undersigned issued an Order of Consolidation, and the matter was set for hearing on November 15, 1996, in Tallahassee, Florida.

At the hearing, ABCT designated Dr. Arthur Koch as its representative. The Board of Medicine designated Dr. Marm

Harris, the Executive Director of the Board of Medicine, as its representative. ABCT called two witnesses: Dr. Arthur Koch and Dr. Marm Harris and submitted three exhibits.1 The Board of Medicine cross-examined Dr. Koch, produced one witness, Dr. Marm Harris, and offered four exhibits that were admitted without objection.2

The parties elected to transcribe the proceedings. At the hearing, the parties requested the right to file proposed findings of fact and conclusions of law in the form of Proposed Recommended Orders. The proposed recommended orders were received, reviewed, and considered by the undersigned.

FINDINGS OF FACT

1. Chelation therapy is the introduction of a man-made amino acid into a patient’s vein. It has been approved by the

   U.S. Food and Drug Administration and is used for the treatment of heavy medal toxicity and the removal of lead.

2. American Board of Chelation Therapy (ABCT) is an autonomous organization that provides education and certification to any physician who wishes to become knowledgeable in Chelation therapy. ABCT was established in 1982 for the purpose of establishing the criteria necessary for certification in the area of Chelation therapy.

3. The Board of Medicine is a statutory entity, established by Chapter 458, Florida Statutes, as the primary regulatory authority for the practice of allopathic medicine in the State of Florida.

4. Pursuant to section 458.301, Florida Statutes, the

   legislature recognizes that the practice of medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The section further provides that the primary legislative purpose in enacting the medical practices act is to “ensure that every physician practicing in this state meets minimum requirements for safe practice.”

5. In keeping with the legislative mandate to ensure that purpose of the medical practices act, the legislature created the Board of Medicine and authorized the Board to create administrative rules for the purpose of implementing chapter 458.

6. Rule 59R-11.001, Florida Administrative Code, is the advertising rule of the Board of Medicine.3 The rule codifies provisions of section 458.331(1)(d), Florida Statutes, and provides criteria for identifying false, deceptive, or misleading advertising.

7. In particular, the rule governs advertising on physician letterhead and limits the use of the term “specialist” unless the specialty is recognized by (1) a specialty board of the American Board of Medical Specialties (ABMS) or (2) a board that meets the requirements of Rule 59R-11.001, Florida Administrative Code.

   For those specialties recognized by organizations that do not meet the requirements of the rule, the physicians may still advertise their specialty so long as they provide a disclaimer. By rule the disclaimer must state the following “The Specialty recognition identified herein has been received from a private

   organization not affiliated with or recognized by the Florida Board of Medicine.”

8. ABMS is generally recognized in the United States as the agency that approves allopathic medical specialty boards and the Board of Medicine has historically relied upon ABMS and its standards and, as reflected in the current rule, continues to rely on ABMS and its standards for approving recognizing agencies.

9. On July 17, 1995, the Petitioner, ABCT submitted an application to Florida Board of Medicine for the purpose of being certified as a “recognizing agency” pursuant to rule 59R-11.001.

10. ABCT is not a specialty board of the ABMS.

11. Because ABCT is not a member board of the ABMS, the Board of Medicine looked to the requirements of rule 59R- 11.001(2)(f) to determine whether ABCT met the criteria enunciated in the rule and whether it is therefore a “recognizing agency” capable of bestowing specialty status on a physician.

12. Rule 59R-11.001(2)(f), Florida Administrative Code, provides that non-ABMS Boards may seek recognition as “recognizing agencies” if they meet the following criteria:

    1. The recognizing agency must be an independent body that certifies members as having advanced qualifications in a particular allopathic medical specialty through peer review demonstrations of competence in the specialty being recognized.

       
       

    2. Specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada that includes substantial

       and identifiable training in the allopathic specialty being recognized.

       
       

    3. Specialty recognition must require successful completion of a comprehensive examination administered by the recognizing agency pursuant to written procedures that ensure adequate security and appropriate grading standards.

       
       

    4. The recognizing agency, if it is not an ABMS board, must require as part of its certification requirement that each member receiving certification be currently certified by a specialty board of the ABMS.

       
       

    5. The recognizing agency must have been determined by the Internal Revenue Service of the United States to be a legitimate not for profit entity pursuant to Section 501 (c) of the Internal Revenue Code.

       
       

    6. The recognizing agency must have full time administrative staff, housed in dedicated office space which is appropriate for the agency’s program and sufficient for responding to consumer or regulatory inquiries.

       
       

    7. The recognizing agency must have written by-laws, and a code of ethics to guide the practice of its members and an internal review and control process including budgetary practices, to ensure effective utilization of resources. However, a physician may indicate the service offered and may state that practice is limited to one or more types of services when this is in fact the case;

13. On April 15, 1996, the Board of Medicine issued an order denying the ABCT’s application for specialty status. As basis for the denial, the order stated that the application of the ABCT failed to establish compliance with the requirements for approval as set forth in Rule 59R-11.001(2)(f), Florida Administrative Code.

14. Specifically, the order stated:

    The requirements for diplomat status in ABCT do not require advanced qualifications in a particular allopathic medicine specialty; specialty recognition given by ABCT does not require completion of an allopathic medical residency program approved by the ACGME or the Royal College of Physicians and Surgeons of Canada that include substantial and identifiable training in the allopathic specialty being recognized; specialty recognition provided by the ABCT does not require successful completion of a comprehensive examination pursuant to written procedures that ensure adequate security and appropriate grading standards in that ABCT requires only a score of 60% to pass the examination, the examination consists of true false questions and answers, and the examination is not a medically comprehensive examination; ABCT is not an ABMS board and does not require that each member it certifies be currently certified by an ABMS board; and ABCT has not provided evidence that it is a legitimate not-for-profit entity pursuant to Section 501(c) of the Internal Revenue Code as determined by the Internal Revenue Service.

    
    

15. Each of the requirements of rule 59R-11.001(2)(f) were addressed at the administrative hearing.

16. With regard to criteria (1) of rule 59R-11.001(2)(f), advanced qualifications in a particular allopathic medical specialty through peer review, the ABCT does not require an advanced qualification in a particular allopathic medical specialty. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(1).

17. Criteria (2) of rule 59R-11.001(2)(f) provides that the specialty recognition must require completion of an allopathic medical residency program approved by either the Accreditation

    Council of Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada.

18. The ACGME is generally recognized as the organization that sets criteria for graduate medical education in the United States. The Board of Medicine has incorporated that recognition in the rule by requiring that the advanced education component of the rule be ACGME approved.

19. The Royal College of Physicians and Surgeons of Canada is ACGME’s counterpart in Canada.

20. With regard to criteria (2) of rule 59R-11.001(2)(f), ABCT does not require completion of an allopathic residency program approved by either the ACGME or the Royal College of Physicians and Surgeons of Canada. In fact, ABCT has no requirement for a residency program. ABCT reasoned that a there is no need for a residency program for Chelation therapists because Chelation therapy does not require overnight hospital stay. The only requirement remotely relating to residency is an ABCT requirement that applicants for diplomat status administer a minimum of 1000 Chelation treatments. There is no requirement that these treatments be supervised and no requirement for verification that the minimum number of treatments were administered.

21. With regard to criteria (3) of rule 59R-11.001(2)(f),

    requiring successful completion of a comprehensive examination, ABCT does not require all applicants for diplomat status to complete a written examination in order to obtain certification.

    Specifically, some candidates are grandfathered in without being required to complete the written examination.

22. For those applicants that are required to submit to an examination, Dr. Arthur L. Koch testified that the examination is composed of approximately sixty percent true/false questions. In addition, Dr. Koch testified that another ten percent of the test is not medically oriented but rather addresses the history and politics of Chelation therapy in the United States.

23. At the hearing, ABCT submitted its Spring 1994 examination as an exhibit. That examination contained a majority true/false questions and a few multiple choice questions.

24. To pass the ABCT diplomat examination, the candidate is required to achieve a score of 62.5 percent. In contrast, the Board of Medicine generally requires a passing score of at least 75%.

25. The Board of Medicine expressed concern about the low

    passing score accepted by ABCT on its certification examination.

    The Board of Medicine also expressed concern over the large number of true/false questions used in the example examination submitted by ABCT. Uncontroverted testimony was presented at the hearing to support a finding that an examination consisting of a majority of true/false questions is not a viable method of testing knowledge.

26. With regard to criteria (4) of rule 59R-11.001(2)(f), requiring members of non-ABMS boards to also be certified by a specialty board of the ABMS, the ABCT does not require that each physician seeking diplomat status be currently certified by an

    ABMS specialty board. Furthermore, ABCT admitted that it does not meet the requirement of rule 59R-11.001(2)(f)(4).

27. With regard to criteria (5) of rule 59R-11.001(2)(f), that the recognizing agency must be a legitimate not for profit entity under the Internal Revenue Code, evidence was presented to verify that ABCT is a non-profit, tax-exempt organization.

28. With regard to criteria (6) of rule 59R-11.001(2)(f), requiring the recognizing agency to have full-time administrative staff sufficient to respond to consumer or regulatory inquiries, no evidence was presented at the hearing relating to this criteria.

29. With regard to criteria (7) of rule 59R-11.001(2)(f), requiring the recognizing agency to have written by-laws and a code of ethics to guide the practice of its members, ABCT submitted its Constitution and Bylaws as adopted in March of 1982 and subsequently amended. The Constitution and bylaws, however, did not include a written code of ethics and therefore did not fully comply with the requirements of the rule.

    CONCLUSIONS OF LAW

30. The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of this proceeding. Section 120.57(1), Florida Statutes. The parties were duly noticed of the formal hearing.

31. ABCT initiated these proceedings under section 120.57(1), Florida Statutes, requesting a formal hearing to review a preliminary order of the Board of Medicine that provided the Board of Medicine’s intent to deny ABCT’s application for

    approval as a “recognizing agency” pursuant to Rule 59R-11.001, Florida Administrative Code. (Case No. 96-3173).

32. Subsequently, ABCT filed a petition pursuant to section 120.56, Florida Statues, to determine the invalidity of rule 59R-11.001(2)(f). (Case No. 96-4963RX).

33. While Case No. 96-4963RX and Case No. 96-3173 were consolidated for the purposes of the hearing, a separate final order validating the challenged rule was rendered in Case No. 96- 4963RX.

34. In the instant case, the Florida Board of Medicine enacted its rule under the statutory mandate to establish such rules and requirements within its regulatory powers as necessary to protect the health, safety, and welfare of the public. The Florida Board of Medicine recognized that while a physician’s accurate representation of recognition as a specialist may be neither false nor deceptive, it may be misleading in that such a representation carries with it the additional weight of advanced qualification and achievement.

35. For numerous reasons stated in the Findings of Fact, ABCT failed to meet the requirements of Rule 59R-11.001(2)(f) and the Board appropriately denied ABCT’s status as a “recognizing agency.”

36. In summary, with the exception of the issue regarding the determination by the Internal Revenue Service that ABCT is a not for profit organization, ABCT has failed to carry its burden to establish that it meets the requirements of Rule 59R-11.001. Furthermore, ABCT has failed to offer any persuasive evidence in

this proceeding to contradict the reasons stated for denial by the Board of Medicine in its preliminary order.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that in Case No. 96-3173, the Board of Medicine enter a Final Order denying ABCT’s application for approval as a “recognizing agency” pursuant to Rule 59R-11.001, Florida Administrative Code.

DONE and ENTERED this 5th day of June, 1997, at Tallahassee, Florida.

WILLIAM A. BUZZETT

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(904) 488-9675 SUNCOM 278-9675

Fax Filing (904) 921-6847

Filed with the Clerk of the Division of Administrative Hearings this 5th day of June, 1997.

ENDNOTES

1 Petition to be certified by the Florida Board of Medicine as a recognizing Agency; American Board of Chelation Written Exam for Spring 1994; and IRS letter dated January 10, 1985, regarding tax exemption status.

2 ABMS handbook; Copy of Rule 59R-11; Copy of Final Order in Feldman v. Board of Medicine; and Copy of Order of Intent to Deny.

3 Prior to its amendment in 1995, this rule had been challenged based, in part, on the rule’s reliance and recognition of the ABMS and its standard. The challenge was resolved in favor of the rules validity finding that the reliance and recognition of the ABMS was consistent with the legislative intent to protect the public. (See Feldman v. Board of Medicine, 16 FALR 2272 (1994).

COPIES FURNISHED:

Gregory D. Seeley, Esquire 800 Bank One Center

600 Superior Avenue, East Cleveland, OH 44114-2655

Allen R. Grossman, Esquire Department of Legal Affairs The Capitol

Tallahassee, FL 32399-1050

Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine

1940 North Monroe Street Tallahassee, FL 32399-0792

Douglas M. Cook, Director

Agency for Health Care Administration 2727 Mahan Drive

Tallahassee, FL 32308

Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive

Tallahassee, FL 32308-5403

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within 15 days from the date of 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: 96-003173

Orders for Case No: 96-003173