STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

CARLOS LEVY, D.O., )

)

Petitioner, )

)

vs. )

) DEPARTMENT OF HEALTH, BOARD OF ) OSTEOPATHIC MEDICINE, )

)

Respondent. )

Case No. 02-2308RX

)

FINAL ORDER

Pursuant to notice, a formal hearing was held in this case on September 18, 2002, in Tallahassee, Florida, before T. Kent Wetherell, II, the designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Fred R. Dudley, Esquire

Akerman, Senterfitt & Eidson, P.A.

301 South Bronough Street Suite 200

Tallahassee, Florida 32301 and

Stephen B. Rakusin, Esquire

1 East Broward Boulevard, No. 1111 Fort Lauderdale, Florida 33301-1865

For Respondent: Edwin A. Bayó, Esquire

Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050

STATEMENT OF THE ISSUE

The issue is whether Rule 64B15-14.008, Florida Administrative Code, which prescribes standards for the practice of telemedicine by osteopathic physicians, is an invalid exercise of delegated legislative authority for the reasons alleged by Petitioner.

PRELIMINARY STATEMENT

On June 11, 2002, Petitioner filed a Petition with the Division of Administrative Hearings (Division) seeking a determination that Rule 64B15-14.008, Florida Administrative Code (Telemedicine Rule), is an invalid exercise of delegated legislative authority. On June 12, 2002, the Petition was assigned to the undersigned and was forwarded to the Department of Health (Department), who was the named Respondent in the original Petition, and the Joint Administrative Procedures Committee. See Section 120.56(1)(c), Florida Statutes.

By Order dated June 18, 2002, the Board of Osteopathic Medicine (Board) was substituted for the Department as the Respondent in this proceeding because the Board promulgated the challenged rule. That Order also granted Petitioner's ore tenus motion to set the final hearing outside of the 30-day period in Section 120.56(1)(c), Florida Statutes. The Board initially opposed the request, but based upon the good cause presented by

Petitioner at the case management conference held on June 17, 2002, the Board ultimately acceded to the request.

On June 18, 2002, Petitioner filed an Amended Petition challenging the Telemedicine Rule. The Amended Petition is identical to the original Petition except that the Amended Petition identifies the Board as the Respondent and it eliminates the request for a stay of the enforcement of the Telemedicine Rule which was in the original Petition.

The hearing was held on September 18, 2002. At the hearing, Petitioner testified in his own behalf and also presented the testimony of Darrin Grey and Dr. Saber Samaan. Petitioner's Exhibits P1 through P5 were received into evidence. Respondent did not call any witnesses at the hearing.

Respondent's Exhibit R1 was received into evidence by stipulation of the parties. Official recognition was taken of Rules 64B15-14.004, 61B15-14.005, and 61B15-15.004, Florida

Administrative Code.

The Transcript of the hearing was filed with the Division on September 30, 2002. The parties agreed to file their proposed final orders (PFOs) within 30 days after the Transcript was filed with the Division, and concomitantly waived the time frame established by Section 120.56(1)(d), Florida Statutes, for entry of this Final Order. By Order dated October 30, 2002, the deadline for filing the PFOs was extended to November 4, 2002.

The parties' PFOs were timely filed and were given due consideration by the undersigned in preparing this Final Order.

FINDINGS OF FACT

Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings are made:

1. Parties

   
   

   1. Petitioner is a licensed osteopathic physician and, as such, he is subject to the Board's licensing and regulatory authority.

   2. Petitioner is certified as a family practitioner. His practice includes prescribing drugs, diagnosis and treatment of diseases, and patient care.

   3. Petitioner typically sees 15 to 18 patients per day in his office.

   4. Petitioner has in the past prescribed legend drugs based solely upon his review of medical questionnaires completed and transmitted over the Internet by persons interested in obtaining specific drugs. Petitioner typically dealt with 50 to

      100 patients per day in this manner. As a result of the Telemedicine Rule, Petitioner no longer prescribes drugs in this manner. (Petitioner's Internet practice is more fully discussed below in Part D.)

   5. Petitioner was compensated for his review of the Internet medical questionnaires by World Wide Web Enterprises, the company that maintained the Internet website through which the medical questionnaires were completed and transmitted by prospective patients. Petitioner was compensated whether or not he issued a prescription to the patient.

   6. Respondent is a regulatory board established within the Department of Health to regulate the practice of osteopathic medicine pursuant to Chapter 459, Florida Statutes.

   7. The Board is a member of the Federation of State Medical Boards (FSMB), and routinely receives reports on various subjects from FSMB. The reports are regularly included as agenda items for Board meetings.

2. The Challenged Rule

   
   

   1. The Telemedicine Rule provides:

      
      

      64B15-14.008 Standards for Telemedicine Practice.

      
      

      1. Prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by reasonably prudent osteopathic physicians as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of an osteopathic physician’s professional practice. Such practice shall constitute grounds for disciplinary action pursuant to Sections 459.015(1)(x) and (t), F.S.

         
         

      2. Osteopathic Physicians shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met:

         
         

         1. A documented patient evaluation, including history and physical examination, adequate to establish the diagnosis for which any drug is prescribed.

            
            

         2. Sufficient dialogue between the osteopathic physician and the patient regarding treatment options and the risks and benefits of treatment.

            
            

         3. Maintenance of contemporaneous medical records meeting the requirements of Rule 64B15-15.004, F.A.C.

            
            

      3. The provisions of this rule are not applicable in an emergency situation. For purposes of this rule an emergency situation means those situations in which the prescribing physician determines that the immediate administration of the medication is necessary for the proper treatment of the patient, and that it is not reasonably possible for the prescribing physician to comply with the provision of this rule prior to providing such prescription.

         
         

      4. The provisions of this rule shall not be construed to prohibit patient care in consultation with another physician who has an ongoing relationship with the patient, and who has agreed to supervise the patient’s treatment, including the use of any prescribed medications, nor on-call or cross-coverage situations in which the physician has access to patient records.

         
         

   2. The Telemedicine Rule became effective on October 16, 2001.

   3. Petitioner did not request a workshop or a public hearing on the proposed rule pursuant to Section 120.54(2)(c) or (3)(c), Florida Statutes, nor did he challenge the proposed rule pursuant to Section 120.56(2), Florida Statutes.

   4. The Telemedicine Rule cites only Sections 459.005 and 459.015(1)(z), Florida Statutes, as the "specific authority" for the rule, and cites only Section 459.015(1)(x) and (1)(t), Florida Statutes, as the "law implemented" by the rule.

   5. The rule does not specifically define "telemedicine"; however, that term is generally understood to mean the practice of medicine through or with the assistance of information technology and electronic communication in circumstances where the patient and the physician are geographically separated.

3. Rule Adoption Process

   
   

   1. March 9, 2001, Board Meeting

   
   

   1. The Board first considered the issues of telemedicine and Internet prescribing of medications at its general business meeting on March 9, 2001.

   2. At that meeting, the Board discussed the FSMB legislative report dated September/October 2000 which had been provided to the Board for "information only." That report did not include any specific findings related to adverse impacts of telemedicine or Internet prescribing of medications. It simply

      summarized legislative activity taken by and/or pending before Congress and the legislatures of other states on those issues.

   3. The Board was also provided a memorandum from FSMB dated January 31, 2001. The memorandum discussed a "clearinghouse" established by FSMB to "facilitate efforts to regulate questionable or 'rouge' websites that offer prescription drugs or other medial services on the basis of an online questionnaire [because] [s]uch prescriptions are issued without an appropriate evaluation by a physician . . . ." The memorandum also referred to and quoted from an April 2000 report prepared by FSMB's Special Committee on Professional Conduct and Ethics (Special Committee).

   4. The Special Committee's report (or at least a portion thereof) was also provided to the Board. In the report, the Special Committee recommended that FASB's member boards:

      consider it an unprofessional conduct for a physician to provide treatment recommendations, including issuing a prescription, via electronic means, unless the physician has obtained a history and physical examination of the patient adequate to establish diagnoses and identify underlying conditions and/or contra- indications to the treatment recommended/provided.

      
      

   5. The report identified several exceptions to this general principle, including emergencies defined by the state medical board, treatment provided in consultation with another

      physician who has an ongoing relationship with the patient, and on-call and cross-call coverage situations.

   6. The Special Committee's report included the following analysis, which is pertinent here:

      Prescribing of medications by physicians based solely on an electronic medical questionnaire clearly fails to meet an acceptable standard of care and is outside the bounds of professional conduct. In order to meet a standard of practice acceptable to the state medical board, the physician should demonstrate that there has been (1) a documented patient evaluation, including history and physical examination, adequate to establish the diagnosis for which the drug is being prescribed and identify underlying conditions and contra- indications (2) sufficient dialogue between the physician and patient regarding treatment options and the risks and benefits of treatment(s) (3) a review of the course and efficacy of treatment to assess therapeutic outcome and (4) maintenance of a contemporaneous medical record that is readily available to patients and their other health care professionals.

      
      

      (Emphasis in original).

      
      

   7. In discussing the agenda item, the Board chairman (Ronald B. Kaufman, D.O.) stated that Internet prescribing without seeing the patient has "kind of been a problem."

      Dr. Kaufman did not elaborate on this comment, but he did state his opinion that "anybody who receives a prescription should have been seen by the physician." No other Board members offered any significant input on the issue.

   8. The dean of the Nova Southeastern University College Osteopathic Medicine addressed the Board on the issue of Internet prescribing. He stated that a committee made recommendations to the Legislature on the issue, but that the committee's draft legislation only got to "first base legislatively." In response, the Board chairman stated "I believe we should be on the forefront rather than waiting for legislative action "

   9. At the conclusion of its discussion, the Board directed its attorney to draft a rule regarding Internet prescribing. Thereafter, the Board initiated the formal rulemaking process.

      2. Notice of Rule Development

      
      

   10. On April 27, 2001, the Board published notice of rule development for the Telemedicine Rule in the Florida Administrative Weekly pursuant to Section 120.54(2)(a), Florida Statutes.

   11. As noted above, Petitioner did not request a rule development workshop. The record does not reflect whether a rule development workshop was requested on the Telemedicine Rule by someone other than Petitioner, nor whether such a workshop was held.

       3. June 8, 2001, Board Meeting

       
       

   12. The Telemedicine Rule was next discussed by the Board at its June 8, 2001, general business meeting.

   13. The record includes almost no detail of the June 8, 2001, meeting. Apparently, no court reporter was present to transcribe the meeting (despite the fact that the minutes reference a court reporter), and the machine used to tape record the meeting malfunctioned. As a result, there is no discernable audio recording of the meeting.

   14. The minutes of the June 8, 2001, meeting do not detail the substance of the Board's discussion on the Telemedicine Rule or the rationale for the Board's decision to approve the Telemedicine Rule. The minutes simply state that "[a]fter much discussion, Dr. Moran moved to APPROVE the language as proposed. Ms. Agudo seconded the motion, which passed unanimously."

   15. Aside from the minutes, the only materials from the June 8, 2001, meetings that were introduced at the hearing were legislative reports from FSMB dated January/February 2001 and March 2001. Those reports did not include any specific findings related to the adverse impact of telemedicine or Internet prescribing of medications. They simply summarized legislative activity taken by and/or pending before Congress and the legislatures of other states on those issues.

       4. Notice of Proposed Rulemaking

       
       

   16. On August 3, 2001, the Board published notice of the Telemedicine Rule in the Florida Administrative Weekly pursuant to Section 120.54(3)(a), Florida Statutes. The notice stated that a public hearing would be held on the Telemedicine Rule if requested within 21 days of the notice and, if requested, notice of the hearing would be published in the Florida Administrative Weekly.

   17. As noted above, Petitioner did not request a public hearing. The record does not reflect whether a public hearing was requested by any other person, nor does it reflect whether a public hearing was held on the rule.

       5. September 21, 2001, Board Meeting

       
       

   18. The Board again discussed the Telemedicine Rule at its general business meeting on September 21, 2001. The notice published in the Florida Administrative Weekly for that meeting did not indicate that its purpose was a public hearing on the rule. Instead, the notice indicated that the subject matter of the meeting was "[r]egular Board business."

   19. The agenda for the September 21, 2001, meeting referred to the meeting as a "rules workshop." The agenda included the parenthetical notation of "status update" beside the Telemedicine Rule agenda item. Despite that notation, the

       transcript of the meeting shows that the Board actually discussed and debated the substance of the Telemedicine Rule.

   20. At the outset of the discussion, the Board attorney noted that the language of the rule is "very close" to the suggested language circulated by FSMB, which it is. Compare Finding of Fact 8 (rule language) with Finding of Fact 18 (FSMB recommendations). The Board's discussion did not include any additional analysis of the standard of practice issues implicated by Internet prescribing of medicine. Instead, the discussion focused on potential loopholes in the rule and a desire not to impact "legitimate uses of teleconferencing."

   21. The only materials from the September 21, 2001, meeting introduced at the hearing (aside from the agenda, minutes, and transcript) were a newsletter and e-mail from FSMB which referenced actions being taken by other states to deal with Internet prescribing of medicines. Neither of those items discussed any standard of practice issues implicated by Internet prescribing.

   22. At the conclusion of the discussion, the Board again unanimously "approved" the Telemedicine Rule. That approval was unnecessary under Chapter 120, Florida Statutes, and served no legal purpose. However, the approval apparently triggered the filing of the rule for adoption with the Secretary of State because the rule was filed several days after the meeting.1

4. Petitioner's Internet Practice2

1. Petitioner prescribed approximately ten different drugs in the course of his Internet practice. Those drugs included Viagra (for erectile disfunction), Propecia (for hair loss), Celebrex (an anti-inflammatory for arthritis), Retin-A (for acne), Claratin (for allergies), and Xenical (for weight loss and treatment of hyperlymphadenias and chronic constipation). Almost 90 percent of the Internet prescriptions ordered by Petitioner were for Viagra and Propecia, with Viagra accounting for 60 to 65 percent of the prescriptions.

2. In his Internet practice, Petitioner received completed medical questionnaires from potential patients. The questionnaires were completed by the patient through the website operated by World Wide Web Enterprises (www.privatedrugstore.com), which Petitioner could then access via his computer. The patient was not told which physician would be reviewing his or her request; the patient was told only that the request would be reviewed by a licensed Florida physician.

3. The Internet medical questionnaire requested basic medical information from the patient -- e.g., age, sex, height, weight, blood pressure level, allergies, history of surgeries, other medicines that the patient was taking. The questionnaires are similar to the medical history forms which Petitioner uses

   for his office patients. The format of the questionnaire required the patient to answer yes or no to each question; however, "text boxes" were provided for the patient to include additional explanation as necessary.

4. The Internet medical questionnaires were specifically tailored to the drug that the patient was requesting. In this regard, the questionnaires were designed to screen out those who absolutely should not be taking the drug, either because of a medical condition the patient has or another medication that the patient is taking. For example, the questionnaire filled out by a patient requesting Viagra specifically asked whether the patient is taking nitrates (which is "contra-indicated" by Viagra, meaning that the two drugs should not be taken together), whether the patient's blood pressure is above or below certain levels, and whether the patient had specified heart-related problems within the past six months.

5. Petitioner did not independently verify the medical history provided by the patient on the Internet questionnaires, nor did he confirm the diagnosis (e.g., erectile disfunction, acne) for which the patient was requesting the prescription; Petitioner simply relied upon the information and diagnosis provided by the patient. While Petitioner also relies upon the medical history information provided by his office patients, he is able to verify some of that information because his standard

   office practice ensures that the patient's vital signs -- e.g., height, weight, blood pressure, heart rate, respiration, temperature -- will be taken. This verification is important because some conditions, such as high blood pressure, have no discernable symptoms to the patient but are contra-indicators for some of the drugs Petitioner prescribed over the Internet, such as Viagra.

6. In circumstances where the patient's answers to the questions on the Internet questionnaire indicated a contra- indication, the computer software automatically rejected the patient's request, and it was not forwarded to Petitioner (or any other physician). For those requests that were forwarded to Petitioner, he reviewed the patient's medical history, as reflected on the medical questionnaire and determined whether the patient should be prescribed the requested medication. He made that determination based solely upon his review of the medical questionnaire and his medical education, training and experience.

7. Petitioner did not make alternative treatment recommendations to the patient; he simply determined whether the patient should receive the drug that he or she requested. In this regard, Petitioner did not assess whether another treatment option -- e.g., testosterone supplements in lieu of Viagra to address erectile disfunction -- might be better for his Internet

   patients. By contrast, Petitioner has the opportunity to (and does) discuss treatment alternatives with those patients that he sees in his office.

8. All of the prescriptions ordered by Petitioner (and the other physicians who review medical questionnaires for World Wide Web Enterprises) are filled by the same pharmacy, which has some sort of relationship with World Wide Web Enterprises. The pharmacy maintains records regarding the patient, including when the medication was last dispensed to the patient and the amount dispensed. The pharmacy's pharmacist has an independent professional obligation to not fill a prescription if he or she has information (such as through the Internet medical questionnaire or some other means) showing that the patient is taking a drug that is contra-indicated.

9. The pharmacy ships the drug to the patient via FedEx, which requires an adult signature for delivery. The person who signs for the drug has to be the person who requested the prescription through the Internet medical questionnaire. This is done in an attempt to ensure that the drug is sent to the person who requested it, and that it is not sent to a minor.

10. The standard of practice which Petitioner follows for the patients he sees in his office is different than the standard of practice that he followed for his Internet patients. The standard practice followed in his office is higher than that

    followed for his Internet patients. In this regard, it is significant that Petitioner did not testify that he would prescribe Viagra, Propecia or the other drugs that he prescribed over the Internet to a new patient who walked into his office without at least taking the patient's vital signs or discussing the treatment options with the patient. Moreover, Petitioner's observations of the patients that he sees in his office help him diagnose the patient and make treatment recommendations -- e.g., identifying the extent of the patient's acne and the need (or not) for Retin-A.

    CONCLUSIONS OF LAW

    
    

    1. Jurisdiction

       
       

11. The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding pursuant to Sections 120.56, 120.569, and 120.57(1), Florida Statutes. (All references to Sections and Chapters are to the Florida Statutes (2001), except as otherwise indicated. All references to Rules are to the Florida Administrative Code.)

    1. Standing

       
       

12. To have standing to challenge the Telemedicine Rule in this proceeding, Petitioner is required to demonstrate that he is "substantially affected" by the rule. See Section 120.56(1)(a), (3)(a). To do so, Petitioner must establish that the application of the rule will result in a real and sufficient

    immediate injury in fact and that the alleged interest is within the zone of interest to be protected or regulated. See, e.g., Florida Board of Medicine v. Florida Academy of Cosmetic Surgery, Inc., 808 So. 2d 243, 250 (Fla. 1st DCA 2002).

13. The Board did not contest Petitioner's standing to challenge the Telemedicine Rule, and the preponderance of the evidence confirms Petitioner's standing. He is a licensed osteopathic physician whose conduct is directly regulated by the Telemedicine Rule. Moreover, the rule caused him to discontinue his practice of prescribing drugs based upon medical questionnaires forwarded to him by World Wide Web Enterprises, and deprived him of the income related thereto.

14. Petitioner's failure to participate in the development of or administratively challenge the Telemedicine Rule prior to its adoption does not affect his standing to challenge the rule in this proceeding. Cf. Dept. of Health & Rehabilitative Servs. v. Alice P., 367 So. 2d 1045, 1053 (Fla. 1st DCA 1979) (dismissal of a challenge to a proposed rule does not prejudice Petitioner's right to challenge the rule after it is adopted).

    1. Burden of Proof

       
       

15. Petitioner has the burden to prove that the Telemedicine Rule is an invalid exercise of delegated legislative authority for the reasons alleged in the Amended Petition, and the rule is entitled to a presumption of validity.

    See St. Johns River Water Management Dist. v. Consolidated- Tomoka Land Co., 717 So. 2d 72, 76 (Fla. 1st DCA 1998) ("Before the 1996 revision of the Administrative Procedure Act, the courts had held that a rule was presumed to be valid, and that the party challenging a rule has the burden of establishing that it is invalid. [T]hese principles continue to apply in a proceeding to challenge an existing rule. . . . ") (citations omitted), rev. denied, 727 So. 2d 904 (Fla. 1999), superceded on other grounds by Chapter 99-379, Sections 2 and 3, Laws of Florida (amending the "flush left" language in Section 120.52(8) and Section 120.536(1)); Cortes v. State Board of Regents, 655 So. 2d 132, 135-36 (Fla. 1st DCA 1995).

16. The statutes and scholarly articles cited by Petitioner in his PFO for the propositions that the Telemedicine Rule is not presumed valid or invalid and that the Board has the burden to prove that the rule is not invalid relate to challenges to proposed rules under Section 120.56(2), not challenges to existing rules under Section 120.56(3). See

    Section 120.56(2)(a) and (2)(c). See also Sellers, The Third Time's the Charm: Florida Finally Enacts Rulemaking Reform, 48 U. Fla. L. Rev. 93, 123-26 (1996) (discussing the 1996 amendments to Chapter 120 which shifted the burden of proof to the agency in challenges to proposed rules, but not in

    challenges to existing rules); Consolidated-Tomoka, 717 So. 2d at 76.

17. The standard of proof is a preponderance of the evidence. See Section 120.57(1)(j).

    1. Rule Validity or Invalidity

       
       

18. An administrative law judge may only invalidate an existing rule if it is an invalid exercise of delegated legislative authority. See Section 120.56(1)(a), (3)(a).

19. Section 120.52(8) defines "invalid exercise of delegated legislative authority" to mean:

    action which goes beyond the powers, functions, and duties delegated by the Legislature. A proposed or existing rule is an invalid exercise of delegated legislative authority if any one of the following applies:

    
    

    1. The agency has materially failed to follow the applicable rulemaking procedures or requirements set forth in this chapter;

       
       

    2. The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)1.;

       
       

    3. The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)1.;

       
       

    4. The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;

       
       

    5. The rule is arbitrary or capricious;

    6. The rule is not supported by competent substantial evidence; or

       
       

    7. The rule imposes regulatory costs on the regulated person, county, or city which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives.

    
    

    A grant of rulemaking authority is necessary but not sufficient to allow an agency to adopt a rule; a specific law to be implemented is also required. An agency may adopt only rules that implement or interpret the specific powers and duties granted by the enabling statute. No agency shall have authority to adopt a rule only because it is reasonably related to the purpose of the enabling legislation and is not arbitrary and capricious or is within the agency's class of powers and duties, nor shall an agency have the authority to implement statutory provisions setting forth general legislative intent or policy. Statutory language granting rulemaking authority or generally describing the powers and functions of an agency shall be construed to extend no further than implementing or interpreting the specific powers and duties conferred by the same statute.

    
    

20. Petitioner's challenge to the Telemedicine Rule is based upon paragraphs (a),3 (b), (c), (d), (e), and (f) of Section 120.52(8) as well as the unlettered, "flush left" paragraph at the end of that subsection. Each of those potential bases for invalidating the Telemedicine Rule is addressed below.

21. Petitioner also alleged in the Amended Petition that the rule violates several constitutional provisions. The

    alleged constitutional deficiencies are not analyzed in this Final Order because it is well-settled that an administrative law judge cannot declare an existing rule unconstitutional. See Dept. of Administration v. Div. of Administrative Hearings, 326 So. 2d 187 (Fla. 1st DCA 1976).

    1. Paragraph (a) -- Material Failure to Follow Applicable Rulemaking Requirements

    
    

22. Petitioner argues that the Telemedicine Rule is invalid under Section 120.52(8)(a) because the Board violated the Sunshine Law -- Section 286.011 -- by failing to maintain adequate minutes of the June 8, 2001, Board meeting at which the Telemedicine Rule was initially approved. More specifically, Petitioner argues that the minutes of that meeting are so deficient that they fail to meet the requirements of Section 286.011(2), which has been construed to require "a brief summary or series of brief notes or memoranda reflecting the events of the meeting[]." See Op. Attn'y Gen. 82-47 (June 22, 1982).

23. A determination as to whether the minutes satisfy the requirements of Section 286.011(2) or are otherwise in compliance with the Sunshine Law is beyond the scope of this proceeding. Those issues must be determined in a judicial forum, not this administrative forum. See Section 286.011(4).

24. A rule may only be invalidated under Section 120.52(8)(a) if the agency "materially failed to follow the

    applicable rulemaking procedures or requirements set forth in this chapter [i.e., Chapter 120]" (emphasis supplied); a rule may not be invalidated under Section 120.52(8)(a) for failure to comply with the procedural requirements in a statute other than Chapter 120, such as the Sunshine Law.

25. Petitioner has not cited any provision of Chapter 120 with which the Board allegedly failed to comply in connection with the preparation of the minutes of its June 8, 2001, meeting. The only provision conceivably implicated is Section 120.54(8), which defines the "rulemaking record" that must be compiled by the agency in connection with its rulemaking activities. That statute does not require "minutes" of the public workshops or public hearings on the rule; it only requires "a written summary of hearings on the proposed rule." See Section 120.54(8)(c). That portion of the minutes of the June 8, 2001, Board meeting relating to the Telemedicine Rule is conclusory in nature, but it does summarize the action taken on the proposed rule at the Board's public hearing, i.e., it was discussed and approved. Accordingly, it satisfies the requirements of Section 120.54(8)(c).

26. Even if Section 120.54(8)(c) or some other provision of Chapter 120 required a more extensive summary of the events of the Board's June 8, 2001, meeting than is found in the minutes of that meeting, there has been no showing by Petitioner

    that the deficiency is material. Accordingly, any deficiency in the minutes would constitute harmless error. See Dept. of

    Health & Rehabilitative Servs. v. Wright, 439 So. 2d 937, 940-41 (Fla. 1st DCA 1983) (compliance with procedural aspects of the rulemaking process is subject to "statutory harmless error rule"). But cf. Section 120.56(1)(c) (failure to follow applicable rulemaking requirements is presumed to be material, but that presumption can be rebutted by a showing that petitioner's substantial interests and the fairness of the proceeding have not been impaired).

27. Indeed, the absence of any meaningful record of the discussion at the Board's June 8, 2001, meeting works in Petitioner's favor. As discussed below in connection with Petitioner's challenge under Section 120.52(8)(f), the "much discussion" that is not explained or elaborated on in the minutes cannot and does not qualify as "legally sufficient evidence" in support of the rule. Thus, even if the Board's failure to maintain detailed minutes of its June 8, 2002, meeting somehow constituted a failure to follow the requirements of Chapter 120, there has been no showing that Petitioner's substantial interests or the fairness of this proceeding have been impaired as a result thereof. See Section 120.56(1)(c).

28. Because Petitioner failed to demonstrate that the Board materially failed to follow the requirements of Chapter

    120 when adopting the Telemedicine Rule, the rule is not an invalid exercise of delegated legislative authority under Section 120.52(8)(a).

    2. Paragraphs (b) and (c) and the "Flush Left" Paragraph -- Authority and Law Implemented

    
    

29. A rule is an invalid exercise of delegated authority if it exceeds the agency's statutory grant of rulemaking authority, Section 120.52(8)(b), or if it enlarges, modifies or contravenes the agency's enabling statute. Section 120.52(8)(c).

30. Paragraphs (b) and (c) are separate but related grounds for invalidating a rule. See Cosmetic Surgery, 808 So. 2d at 253; Board of Trustees of the Internal Improvement Trust Fund v. Day Cruise Ass'n, Inc., 794 So. 2d 696, 701 (Fla. 1st DCA 2001). They are related by virtue of the final, unlettered paragraph in Section 120.52(8), which is commonly referred to as the "flush left" paragraph.

31. The "flush left" paragraph is, in effect, a legislative gloss on paragraphs (b) and (c) which explains the type of statute that may be relied upon as "rulemaking authority" and identifies the aspects of the enabling statute (i.e., "law implemented") that may be interpreted or implemented through rules. Identical language is contained in Section 120.536(1).

32. The "flush left" paragraph was added in 1996 as part of the comprehensive revision of Chapter 120, see generally

    Boyd, Legislative Checks on Rulemaking Under Florida's New APA, 24 Fla. St. U. L. Rev. 309, 338-42 (1997) (extensively discussing the purpose, intent, and meaning of the "flush left" paragraph), and it was substantially amended in 1999 in direct response to the First District Court of Appeal's decision in Consolidated-Tomoka. The 1999 amendments expressly rejected the construction given to the "flush left" paragraph by the court in Consolidated-Tomoka.

33. The "flush left" paragraph, as amended in 1999, was first judicially construed in Southwest Florida Water Management District v. Save the Manatee Club, 773 So. 2d 594 (Fla. 1st DCA 2000). In that case, the court affirmed a final order which invalidated a rule exempting projects with prior development approvals from certain permitting requirements. Id. at 600. The court concluded that the enabling statute only authorized exemptions based upon the absence of environmental impact, not exemptions based upon prior approvals. Id. The court construed the amended "flush left" paragraph as follows:

    [T]he authority for an administrative rule is not a matter of degree. The question is whether the statute contains a specific grant of legislative authority for the rule, not whether the grant of authority is specific enough. Either the enabling statute authorizes the rule at issue or it

    does not. [T]his question is one that must be determined on a case-by-case basis.

    
    

    Id. at 599 (emphasis original).

    
    

34. The First District Court of Appeal next considered and applied the amended "flush left" paragraph in Day Cruise. In that case, the court affirmed a final order which invalidated a rule prohibiting so-called "cruises to nowhere" from docking on State lands. Day Cruise, 794 So. 2d at 704.

35. The majority opinion in Day Cruise, authored by Judge Benton, concluded that the rule "transgresses" the enabling statute's grant of rulemaking authority which prohibited rules that interfere with commerce (id. at 702) and that a rule singling out "cruises to nowhere" for special treatment is not authorized by the enabling statute because the statute does not reference gambling or "cruises to nowhere" (id. at 704). Judge Benton construed the amended "flush left" language to mean that:

    agencies have rulemaking authority only where the Legislature has enacted a specific statute, and authorized the agency to implement it, and then only if the rule implements or interprets specific powers or duties, as opposed to improvising in an area that can be said to fall only generally within some class of powers or duties the Legislature has conferred on the agency.

    
    

    Id. at 700. And see id. at 705-06 (Browning, J., concurring) (concluding that the "cruises to nowhere" rule is invalid

    because the enabling statute authorizes only the regulation of anchoring and mooring, and not the prohibition of such).

36. The First District Court of Appeal next applied the amended "flush left" paragraph in Cosmetic Surgery. In that case, the court reversed a final order which invalidated several rules that imposed restrictions on office surgeries. Cosmetic

    Surgery, 808 So. 2d at 253-58. The court concluded that the rule requiring physicians performing level II office surgery to have a transfer agreement with a nearby hospital was authorized by the enabling statute which specifically referenced "transfer agreements." Id. at 253-54. Similarly, the court determined that the rule requiring physicians performing level III office surgery to have staff privileges at a nearby hospital was authorized by the enabling statute that directed the agency to establish standards for "particular practice settings." Id. at 254.

37. Most recently, the First District Court of Appeal applied the amended "flush left" language in Hennessey v. Dept.

    of Business and Professional Regulation, 818 So. 2d 697 (Fla. 1st DCA 2002).4 In that case, the court affirmed a final order which upheld the rule requiring the animal trainer to be the "absolute insurer" of the condition of the animals entered by the trainer in a dog or horse race. Id. at 700-01. The court concluded that the statutes which authorized the agency to

    "adopt reasonable rules for the control, supervision and direction of all . . . licensees" and authorized the agency to take administrative action against "a [responsible] occupational licensee . . . for the condition of an animal that has been impermissibly medicated or drugged" were sufficient to support the rule at issue. Id. at 701 ("A plain reading of the authorizing statutes in this case demonstrates that the legislature granted the department the specific authority to hold a trainer responsible for the condition of the horses which he trains if these horses are raced with any drug in their system.")

38. The majority opinion in each of these cases was written by a different member of the court -- i.e., Judge Padavano (Save the Manatee), Judge Benton (Day Cruise), Judge Webster (Cosmetic Surgery), and Judge Wolf (Hennessey) -- and only Judges Miner and Wolf were on more than one panel. As a result of the minimal overlap in the panels and because of the ad hoc nature of the standard announced in Save the Manatee and purportedly applied in each of the subsequent cases, it is somewhat difficult to discern a common theme from the cases.

39. If a common theme exists, it appears to be that in order to be valid, a rule must be based upon an enabling statute that makes a specific reference to the subject of the rule, and the rule must not be inconsistent with any limitations imposed

    by the enabling statute. The rule invalidated in Save the Manatee did not meet the latter requirement; the rule invalidated in Day Cruise met neither requirement; and the rules upheld in Cosmetic Surgery and Hennessey met both.

40. In this case, Petitioner has not identified any provision of the Board's enabling statutes with which the rule is allegedly inconsistent (a la Save the Manatee). Instead, the focus of Petitioner's challenge is the absence of a specific enabling statute authorizing and directing the Board to regulate (or prohibit) the practice of telemedicine. See Petitioner's PFO, at 21.

41. Petitioner is correct that the Board's enabling statutes do not make specific reference to telemedicine or prescriptions by electronic means; however, Section 459.015(1)(z) specifically provides that "[t]he board may establish by rule standards of practice and standards of care for particular practice settings" (emphasis supplied),5 and Sections 459.015(1)(t) and (1)(x) authorize the Board to take disciplinary action against osteopathic physicians who inappropriately prescribe legend drugs and who fail to practice with the level of care of a reasonably prudent osteopathic physician. The absence of specific reference in these statutes to telemedicine or prescriptions by electronic means is not determinative because as the Court held in Save the Manatee, 773

    So. 2d at 599, the issue is not whether the enabling statute is "specific enough."

42. Granted, the discussion of the issue of specificity in Save the Manatee is difficult to square with that portion of Judge Benton's opinion in Day Cruise which emphasized the absence of any specific reference to gambling or the day cruise industry in the agency's enabling statutes. Day Cruise, 794 So. 2d at 703-04. In light of Judge Allen's observation in his dissent that the enabling statute at issue did make reference to "vessels, floating homes, or any other watercraft" which would seem to "encompass the vessels being used for gambling cruises" it would appear that the requisite level of specificity existed for the rule. Id. at 706-07 (Allen, J., dissenting).

43. In this regard, it appears that the significance which Judge Benton placed upon the absence of a specific reference to gambling or the day cruise industry was based more on the fact that the Legislature had twice refused to enact legislation to prohibit cruises to nowhere,6 see id. at 704 n.8, than it was on a view that a greater degree of specificity than "vessels" is required in order for the agency to regulate specific types of vessels. Indeed, on rehearing, Judge Benton clarified that his analysis in Day Cruise was "fully consonant with the decision in Save the Manatee Club." See Board of Trustees of the Internal Improvement Trust Fund v. Day Cruise Ass'n, Inc., 798 So. 2d 847

    (Fla. 1st DCA 2001) (on motion for rehearing and/or clarification) [hereafter "Day Cruise Opinion on Rehearing"]. Accordingly, Day Cruise does not support the proposition advocated by Petitioner that a specific statutory reference to telemedicine or prescriptions by electronic means is necessary to support the Telemedicine Rule. Indeed, the rules upheld in Cosmetic Surgery and Hennessey were based upon statutes whose level of specificity was similar to that in Sections 459.015(1)(t), (1)(x), and (1)(z).

44. Indeed, the rules upheld in Cosmetic Surgery were based on Section 458.331(1)(v), which is virtually identical to Section 459.015(1)(z). See Cosmetic Surgery, 808 So. 2d at 253. Although one of the rules upheld involved "transfer agreements" and Section 458.331(1)(v) specifically included that term, id.

    at 253-54, the other rule that was upheld required physicians performing office surgeries to have staff privileges at a nearby hospital and the enabling statute made no specific reference to "staff privileges." Id. at 254. Nevertheless, the court concluded that the statutory authority to establish "standards of practice and standards of care for particular practice settings" provided the board sufficient authority to adopt the staff privileges rule. Id. Specifically, the court stated:

    Section 458.331(1)(v) clearly gives broad, unqualified, rulemaking authority to the Board to establish "standards of practice

    and standards of care for particular practice settings." It does not specify what those standards should be, or how they should be established, leaving such matters to the discretion of the Board.

    
    

    Id. The same analysis applies with respect to Section 459.015(1)(z) and the Telemedicine Rule which, as discussed below, defines a standard of practice for osteopathic physicians in the "virtual" or Internet practice setting.

45. The Day Cruise opinion demonstrates the importance given to the characterization of the substance of the rule in determining whether, as Judge Padavano stated in Save the

    Manatee, 773 So. 2d at 599, the "enabling statute authorizes the rule at issue or it does not." Judge Benton characterized the rule at issue in Day Cruise to be a rule regulating the day cruise industry which the enabling statute does not authorize the agency to regulate, Day Cruise, 794 So. 2d at 703-04; Day Cruise Opinion on Rehearing, 798 So. 2d at 848, while Judge Allen characterized it as an anchoring and mooring rule authorized by the statute. Day Cruise, 794 So. 2d at 706-07 (Allen, J., dissenting). Judge Benton's characterization of the rule dictated the outcome of Day Cruise, and the proper characterization of the Telemedicine Rule is similarly important in this case.

46. The Board characterizes the Telemedicine Rule as simply prescribing a standard of practice and standard of care

    for osteopathic physicians, which the Board is authorized and directed to do by the Legislature. Respondent's PFO, at 12-13. By contrast, Petitioner characterizes the rule as an attempt to "ban" or "prohibit" Internet prescribing and telemedicine, which should be done, if at all, by the Legislature, not the Board.

    Petitioner's PFO, at 21. While there is merit to each party's position, the Board's characterization of the rule is more consistent with its terms.

47. The Telemedicine Rule does not absolutely prohibit "telemedicine" generally or, more specifically, the practice of osteopathic medicine through electronic means. Subsection (1) of the rule simply provides that "prescribing medications based solely on an electronic medical questionnaire" falls below the standard of care for osteopathic physicians. Neither Subsection

    (1) nor any other provision of the Telemedicine Rule states that prescribing medications based on an electronic medical questionnaire falls below the standard of care in all circumstances. Indeed, by negative implication, Subsection (2) of the rule permits osteopathic physicians to provide treatment recommendations and issue prescriptions by electronic means if the "elements" of that subsection (or the exceptions in Subsections (3) and (4)) are met. In this regard, nothing in the rule prohibits an osteopathic physician from utilizing an electronic medical questionnaire, in conjunction with the

    elements required by Subsection (2), to provide treatment recommendations or prescribe medications.

48. In sum, the Telemedicine Rule simply prescribes the standards of practice for osteopathic physicians who utilize Internet questionnaires or other electronic means as part of their practice of prescribing medications. Accordingly, the rule falls within the grant of rulemaking authority in Section 459.015(1)(z), and it interprets and implements Section 459.015(1)(t) and (1)(x). Accordingly, the telemedicine Rule is not an invalid exercise of delegated authority under Section 120.52(8)(b), (8)(c), or the "flush left" paragraph.

    3. Paragraph (d) -- Vagueness

    
    

49. A rule is an invalid exercise of delegated legislative authority if it is vague. Section 120.52(8)(d).

50. More specifically, a rule is invalid under Section 120.52(8)(d) if it "requires performance of an act in terms that are so vague that men of common intelligence must guess at its meaning." Southwest Florida Water Management District v.

    Charlotte County, 774 So. 2d 903, 915 (Fla. 2nd DCA 2001). See also Cole Vision Corp. v. Dept. of Business and Professional Reg., 688 So. 2d 404 (Fla. 1st DCA 1997).

51. Where, as here, violation of the rule has penal consequences, the test for vagueness is whether the rule gives a person of ordinary intelligence fair notice of what constitutes

    proscribed conduct. See, e.g., McGuire v. State, 489 So. 2d 729, 732 (Fla. 1986).

52. In the Amended Petition, Petitioner alleged that the Telemedicine Rule was vague because the terms and phrases "prescription," "medications," "electronic medical questionnaire," "electronic or other means," "adequate to establish the diagnosis," and "sufficient dialogue" used in the rule are not defined by statute or rule. Amended Petition at 3. See also Petitioner's PFO, at 8-9, 20. The preponderance of the evidence does not support Petitioner's contentions.

53. The terms "prescription" and "medications" have common and ordinary meanings, which are understandable to osteopathic physicians such as Petitioner. Although the rule does not specifically define "medications" to include only legend drugs to the exclusion of non-legend drugs such as aspirin, contrary to Petitioner's argument (Petitioner's PFO, at 9, Paragraph 30.c.), it cannot be reasonably construed otherwise since the term follows the word "prescribing" and only legend drugs require a prescription. Cf. Section 459.015(1)(t).

54. As to the other allegedly vague terms, Petitioner conceded at the hearing that he understood the terms "electronic medical questionnaire" and "electronic or other means" to encompass the Internet questionnaires that he reviewed through World Wide Web Enterprises, and further testified that his

    medical education, training and experience would enable him to determine whether his dialogue with the patient was "sufficient" and "adequate to establish the diagnosis" since those are matters of medical judgment. Indeed, as Petitioner acknowledged at the hearing, the rule could not define these terms in a manner that would apply in all circumstances because what is adequate for one patient (or one drug) may be inadequate for another. Cf. Cole Vision, 688 So. 2d at 410 ("The sufficiency of a rule's standards and guidelines may depend upon . . . the degree of difficulty in articulating finite standards.").

55. Similarly, there was no evidence presented at the hearing that Petitioner provides "treatment recommendations" other than issuing a prescription in connection with his work for World Wide Web Enterprises. Accordingly, the rule's failure to define "treatment recommendations" does not render the rule vague as it relates to Petitioner's work with World Wide Web Enterprises. To the extent that the term "treatment recommendations" could include a recommendation by the physician that a patient discontinue taking medication, the rule does not require another physical evaluation as Petitioner contends (Petitioner's PFO, at 9, Paragraph 30.d.). Indeed, assuming that the physician had complied with the rule by conducting a physical examination when the drug was prescribed, the requirement of Subsection (2)(a) of the Telemedicine Rule would

    already be satisfied. Accordingly, so long as the physician complied with the other elements of Subsection (2) of the rule -

    - particularly Subsection (2)(b) which requires dialogue with the patient regarding "the risks and benefits of treatment" -- the physician's recommendation that the patient discontinue taking medication without a subsequent physical examination would not appear to be a violation of the rule.7

56. Furthermore, the rule is not vague because it fails to specify the time intervals between the physical evaluation and the issuance of a prescription as argued by Petitioner (Petitioner's PFO, at 8, Paragraph 30.b.). The requirement of a patient evaluation (which includes the physical examination) is qualified by the phrase "adequate to establish the diagnosis" which, as discussed above, presumes that the physician is using his or her medical judgment in determining what is adequate for the patient (or drug) at issue. With respect to the physical evaluation, the determination of adequacy would be both as to the extent of the physical examination and its currency.

57. Because Petitioner failed to demonstrate that the Telemedicine Rule is vague in whole or in part, the rule is not an invalid exercise of delegated legislative authority under Section 120.52(8)(d).

    4. Paragraph (e) -- Arbitrary and Capricious

    
    

58. A rule is an invalid exercise of authority if it is "arbitrary or capricious." Section 120.52(8)(e).

59. A rule is arbitrary if it is not supported by facts or logic and is capricious only if it is irrational. See Cosmetic Surgery, 808 So. 2d at 255 (citing Board of Clinical Lab. Pers.

    v. Fla. Ass'n of Blood Banks, 721 So. 2d 317, 318 (Fla. 1st DCA 1998)). Accord Agrico Chemical Co. v. Dept. of Environmental Reg., 365 So. 2d 759, 763 (Fla. 1st DCA 1979).

60. The determination as to whether the challenged rule is arbitrary or capricious is made based upon the record of the de novo rule challenge hearing, and not just the "rulemaking record" created by the agency prior to the adoption of the rule. Cosmetic Surgery is not contrary authority because that portion of Cosmetic Surgery which likens the rule challenge proceeding to certiorari review (and, thus, appears to restrict the administrative law judge to reviewing the "rulemaking record") relates only to Section 120.52(8)(f).8

61. The FSMB reports and other substantive information in the rulemaking record (Exhibit R1) were not authenticated at the rule challenge hearing, and the matters asserted in the reports are hearsay which have not been corroborated by any other testimony or evidence introduced at the rule challenge hearing.9 Therefore, those materials cannot be (and were not) considered

    in connection with Petitioner's challenge under Section 120.52(8)(e). See Section 120.57(1)(c) (uncorroborated hearsay cannot serve as a basis for a factual finding). Nevertheless, the preponderance of the evidence received at the hearing demonstrates that the Telemedicine Rule is not irrational and is supported by facts and logic.

62. Specifically, it is not irrational for the Board to require osteopathic physicians to have some interaction with their patients in addition to a medical history questionnaire submitted by a patient over the Internet in connection with a drug request. In this regard, one thing that the Telemedicine Rule seeks to prevent is the issuance of a prescription based upon incorrect (whether intentionally fabricated by the patient or not) or incomplete medical history information. Petitioner acknowledged at the hearing that when he sees patients in his office he is able to verify some of the medical information and history that he is given by the patient (e.g., vital signs), which is something that he cannot do with the patients who he "sees" only through the Internet.

63. The Telemedicine Rule also seeks to ensure that the physician will discuss with the patients the risks and benefits associated with the treatment recommendations and, presumably, the alternatives which may be available. Petitioner's Internet practice (which is clearly the type of practice targeted by the

    Telemedicine Rule) does not provide for such because there is virtually no interaction between Petitioner and the patient and Petitioner's treatment recommendation is simply yes or no to the specific drug requested; Petitioner does not discuss alternatives to the requested medication, nor does Petitioner provide the patient other treatment recommendations (e.g., lose weight, exercise) which might be of benefit to the patient and which Petitioner would more likely be in a position to offer in a more traditional office setting.

64. The crux of Petitioner's arbitrary and capricious argument is that the rule does not prohibit conduct which is substantially similar to that which is prohibited, thereby rendering the rule illogical. See Petitioner's PFO, at 8, Paragraph 30.a. Specifically, Petitioner argues that the rule does not prohibit an osteopathic physician from issuing a prescription based solely on a medical questionnaire filled out by the patient in the physician's office (rather than over the Internet). Id. The record does not support the theoretical possibility of this occurring because, as Petitioner conceded at the hearing, his standard office practice is to require some degree of physical evaluation (e.g., taking the patient's vital signs) of all patients who come into the office seeking a prescription or other treatment recommendations.

65. The remainder of Petitioner's arbitrary and capricious arguments (Petitioner's PFO, at 8-9, paragraphs 30.b. through 30.e) are actually vagueness arguments since they contend that the Telemedicine Rule fails to specify critical information (e.g., time intervals between physical examination and issuance of the prescription) and that the scope of the rule is indeterminable based upon the inclusion of certain terms (e.g., "treatment recommendations") and the failure to define others (e.g., "medications"). Those arguments are addressed above in connection with Section 120.52(8)(d) above.

66. Unlike Cosmetic Surgery where the Board of Medicine promulgated the office surgery rules after it "became aware of a number of office surgery deaths and other adverse incidents," 808 So. 2d at 248-49, there was not any evidence presented by the Board at the rule challenge hearing (or included within the rulemaking record) in this case documenting public health problems which had occurred as a result of Internet prescriptions ordered by osteopathic physicians. The absence of such evidence is not dispositive, however, because agencies are not precluded from addressing potential problems before they arise. Indeed, the Board should be commended for its proactive approach so long as it acted within the authority delegated to it by the Legislature which, as discussed above, it did.

67. Because Petitioner failed to demonstrate that the Telemedicine Rule is arbitrary or capricious, the rule is not an invalid exercise of delegated legislative authority under Section 120.52(8)(e).

    5. Paragraph (f) -- Competent Substantial Evidence

    
    

68. A rule is an invalid exercise of delegated legislative authority if it is "not supported by competent substantial evidence." Section 120.52(8)(f).

69. Section 120.52(8)(f) was added in 1996 as part of the comprehensive revision of Chapter 120. See generally Rhea & Imhof, An Overview of the 1996 Administrative Procedure Act, 48 U. Fla. L. Rev. 1, 28-29 (1996); Sellers, supra, at 131-32; Boyd, supra, at 332-33 nn. 142-43

70. Section 120.52(8)(f) was judicially construed for the first time in Cosmetic Surgery. In that case, the court concluded that the phrase "competent substantial evidence" in Section 120.52(8)(f) is not a standard of proof,10 but rather is a standard of review which does not allow the administrative law judge to "reweigh the evidence, make determinations regarding credibility or substitute [his or her] judgment for that of the agency, even if the record contains some evidence supporting a contrary view." Cosmetic Surgery, 808 So. 2d at 257. In this regard, the court held that the scope of the administrative law judge's review of a challenge based upon Section 120.52(8)(f) is

    limited to determining whether "legally sufficient evidence exists supporting the agency's proposal." Id.

71. As suggested in Cosmetic Surgery and as emphasized by the Florida Supreme Court in Dusseau v. Metropolitan Dade County Bd. Of County Com'rs, 794 So. 2d 1270 (Fla. 2001), the competent substantial evidence standard of review is extremely narrow:

    [T]he "competent substantial evidence" standard cannot be used by a reviewing court as a mechanism for exerting covert control over the policy determinations and factual findings of the local agency. Rather, this standard requires the reviewing court to defer to the agency's superior technical expertise and special vantage point in such matters. The issue before the court is not whether the agency's decision is the "best" decision or the "right" decision or even a "wise" decision, for these are technical and policy-based determinations properly within the purview of the agency. The circuit court has no training or experience--and is inherently unsuited--to sit as a roving "super agency" with plenary oversight in such matters.

    
    

    The sole issue before the court on first- tier certiorari review is whether the agency's decision is lawful. The court's task . . . is simple: The court must review the record to assess the evidentiary support for the agency's decision. Evidence contrary to the agency's decision is outside the scope of the inquiry at this point, for the reviewing court above all cannot reweigh the "pros and cons" of conflicting evidence. While contrary evidence may be relevant to the wisdom of the decision, it is irrelevant to the lawfulness of the decision. As long as the record contains competent substantial evidence to support the agency's decision,

    the decision is presumed lawful and the court's job is ended.

    
    

    Id. at 1275.

    
    

72. The Cosmetic Surgery opinion did not explain whether the "legally sufficient evidence" supporting the rule must be found in the agency's rulemaking record or whether it may be in the record of the rule challenge proceeding before the administrative law judge. However, the court's characterization of rule challenge proceedings as "technically de novo"11 akin to certiorari review by the circuit court12 (where review is clearly limited to the record of the lower tribunal, see Dade County v.

    Marca, S.A., 326 So.2d 183 (Fla. 1976)) suggests that it intended to limit the administrative law judge's review under Section 120.52(8)(f) to the rulemaking record. At least one commentator has interpreted the decision in that manner, see

    Blanton, supra, as did the parties to this case.

    
    

73. Specifically, the Board took the position that the rulemaking record (Exhibit R1) contained the requisite competent substantial evidence to support the rule, and it did not introduce any other evidence at the rule challenge hearing. Similarly, at the outset of the hearing, Petitioner sought to preclude the Board from introducing any other evidence from the rulemaking hearings to support the rule other than that in the written rulemaking record. That effort became moot when the

    Board decided not to put on any evidence other than the stipulated Exhibit R1. In light of the parties' apparent agreement that review under Section 120.52(8)(f) is limited to the rulemaking record (which is consistent with the undersigned's reading of Cosmetic Surgery), the determination as to whether the Telemedicine Rule is supported by competent substantial evidence will be based only on the rulemaking record introduced at the hearing, i.e., Exhibit R1.

74. In its PFO (at pages 14-17), Petitioner argues that none of the information in the rulemaking record constitutes competent substantial evidence to support the Telemedicine Rule because it is all uncorroborated hearsay upon which the administrative law judge cannot rely in making findings of fact. See Sections 120.569(2)(g) and 120.57(1)(c) (hearsay is admissible in administrative proceedings but may not serve as the sole basis for a finding of fact). Petitioner is correct that the rulemaking record is permeated with uncorroborated hearsay, most of which was not authenticated at the rule challenge hearing; however, in light of Cosmetic Surgery, the focus of review under Section 120.52(8)(f) is not whether the information relied upon by the agency in adopting the rule is "legally sufficient" for the administrative law judge to rely upon under Sections 120.569(2)(g) and 120.57(1)(c), because that would be a standard of proof; instead, the focus is whether that

    information was "legally sufficient" for the agency to rely upon when it adopted the rule.

75. While there is authority for the proposition that hearsay does not constitute competent substantial evidence for purposes of certiorari review, see, e.g., Campbell v. Vetter,

    392 So. 2d 6 (Fla. 4th DCA 1980) (trial court properly quashed personnel board's decision to terminate police officer because record of board's hearing was "permeated" with hearsay evidence); Spicer v. Metropolitan Dade County, 458 So. 2d 792 (Fla. 3d DCA 1984) (trial court should have granted certiorari and quashed county's decision to terminate police officer where that decision was based solely on uncorroborated hearsay), those cases arose out of quasi-judicial proceedings before local administrative bodies. Rulemaking, however, is a quasi- legislative proceeding and the evidentiary quality of the information developed by and relied upon by an agency in rulemaking is typically not of the same quality as evidence introduced at a formal administrative (or other quasi-judicial) hearing. Indeed, in Adam Smith, the court recognized that the rulemaking record:

    often contains soft information which is difficult for the court to weigh and which is less reliable than that which is found in formal proceedings wherein evidentiary safeguards are applicable.

    The record in informal rulemaking often contains generalized rather than specific information, evidence that is untested by cross-examination, and conclusory information based upon data submitted by interested parties. In addition, rulemaking decisions frequently turn on policy considerations which do not easily lend themselves to the test of substantial evidence. Moreover, because an informal record includes the written submissions of any interested party, it may be voluminous and technically complex and disorganized.

    Naturally, an informal record of this sort cannot be reviewed in quite the same way as a formal adjudicatory record in which the issues are refined and the positions of the parties clearly delineated.

    
    

    Adam Smith, 553 So. 2d at 1271 (citations and footnotes omitted). Accord Baillie v. Department of Natural Resources, 632 So. 2d 1114, 1117 n.6 (Fla. 1st DCA 1994).

76. In light of the court's recognition in Adam Smith of the nature and quality of the "evidence" in the rulemaking record, the court could not have intended in Cosmetic Surgery to hold (as Petitioner argues) that hearsay in the rulemaking record could not constitute substantial competent evidence to support the rule. Indeed, if Petitioner's argument were adopted, the problems foreshadowed in Adam Smith would become a reality, to wit:

    To impose a competent substantial evidence standard of review on agency rulemaking would force rulemakers to adopt more formal, rigid, trial-like procedures in an attempt to make an adequate record capable of judicial review. A general paralysis of

    administration would result, and rulemaking would lose most of its peculiar advantages as a tool of administrative policy making. Trial- like adjudication would be extremely costly in time, staff, and money. Orderly innovation would be difficult. To discern basic agency policy, the public would often have to wade through volumes of scarcely relevant testimony and findings. Especially in the rapidly expanding realms of economic, environmental, and energy regulation, the policy disputes are too sharp, the technological considerations too complex, and the interests affected too numerous to require agencies to rely on the ponderous workings of adjudication.

    
    

    Adam Smith, 553 So. 2d at 1272 n.16.

    
    

77. The issue in Adam Smith was the appropriate standard of review for direct appeals of agency rules.13 The court expressly rejected the argument that the competent substantial evidence standard was the appropriate standard of review. See Adam Smith, 553 So. 2d at 1271. It is somewhat ironic that through its decision in Cosmetic Surgery the court appears to have created for administrative law judges the same problems that it was successfully able to avoid for itself in Adam Smith and Baillie. Nevertheless, if those problems are to be remedied, it will have to be done by the court through reconsideration of its construction of Section 120.52(8)(f),14 or by the Legislature through an amendment to or repeal of Section 120.52(8)(f). See Blanton, supra (suggesting that the Legislature should repeal Section 120.52(8)(f)).

78. Turning back to the circumstances of this case, the issue is whether the information in the rulemaking record was "legally sufficient" for the Board to rely upon in promulgating the Telemedicine Rule. In light of the recognition in Adam Smith of the non-evidentiary nature of information compiled during rulemaking, the facts that the various FSMB reports in Exhibit R1 were not authenticated and that their substance is uncorroborated hearsay does not render it legally insufficient for the Board to rely upon.

79. Indeed, because the Board is a member of FSMB and routinely receives reports from FSMB, it was not unreasonable for the Board to choose to rely upon those reports as a basis for its decision to promulgate the Telemedicine Rule. Under the present state of the law, it is not for the undersigned to determine whether those reports are accurate, credible, or whether the Board should have given more weight to something other than the information that it had before it when it promulgated the rule. See Cosmetic Surgery, 808 So. 2d at 257-

    58 ("the ALJ should not . . . independently reweigh[] the evidence, assess[] the credibility thereof, or substitute[] his judgment for the wisdom of the rules for that of the Board").

80. Although the rulemaking record is somewhat sparse (primarily due to the absence of any meaningful record of the "much discussion" referenced in the minutes of the June 8, 2001,

    Board meeting), the information that it does contain is "sufficiently relevant and material that a reasonable mind would accept it as adequate to support the conclusion reached." Cosmetic Surgery, 808 So. 2d at 257. Specifically, the FSMB reports that are in the rulemaking record (particularly the April 2000 Select Committee report15) discuss problems with Internet prescribing from a standard of practice perspective and recommend model language for FSMB member boards to adopt. Those reports are "corroborated" by the comments of the Board chairman at the June 8, 2001, Board meeting that Internet prescribing without seeing the patient has "kind of been a problem" and his opinion that "anybody who receives a prescription should have been seen by the physician."

81. Even if the FSMB reports and the comments of the Board chairman were all factually incorrect, the establishment of a standard of practice in the first instance as well as the particular standards prescribed in the Telemedicine Rule are infused with policy considerations rather than facts susceptible to proof by ordinary means. Compare Gross v. Dept. of Health, 819 So. 2d 997, 1002-03 (Fla. 5th DCA 2002) (determination as to whether established standard of practice was violated is a factual determination susceptible to ordinary methods of proof). Accordingly, in this instance, the factual accuracy or inaccuracy of the information in the rulemaking record relied

    upon by the Board is immaterial to the validity of the Telemedicine Rule under Section 120.52(8)(f). See Adam Smith,

    553 So. 2d at 1271 (noting that "rulemaking decisions frequently turn on policy considerations which do not easily lend themselves to the test of substantial evidence"). And cf.

    Bayó and Rimes, supra.

    
    

82. Because Petitioner failed to demonstrate that rulemaking record for the Telemedicine Rule is devoid of any competent substantial evidence to support the rule, the rule is not invalid under Section 120.52(8)(f).

    1. Attorneys' Fees

    
    

83. Petitioner requested an award of attorneys' fees and costs in the Amended Petition. Neither the Amended Petition nor Petitioner's PFO specified the statutory basis for the request; however, the only conceivable basis is Section 120.595(3).

84. Section 120.595(3) provides that if the administrative law judge declares an existing rule invalid, an "order shall be rendered against the agency for reasonable costs and attorney's fees, unless the agency demonstrates that its actions were substantially justified or special circumstances exist which would make the award unjust." (Emphasis supplied.) In light of the foregoing determination that the Telemedicine Rule is not an invalid exercise of delegated legislative

authority, Petitioner is not entitled to an award of attorney's fees and costs under Section 120.595(3).

ORDER

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

ORDERED that the Amended Petition is dismissed. DONE AND ORDERED this 3rd day of December, 2002, in

Tallahassee, Leon County, Florida.

T. KENT WETHERELL, II Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 3rd day of December, 2002.

ENDNOTES

1/ The record does not contain any direct evidence of the date that the Telemedicine Rule was filed with the Secretary of State. However, because the Telemedicine Rule did not specify an effective date, it became effective 20 days after it was filed with the Secretary of State pursuant to Section 120.54(3)(e)6., Florida Statutes, and because the rule became effective on October 16, 2001, it must have been filed with the Secretary of State on September 26, 2001.

2/ The record does not reflect whether Petitioner's Internet practice is typical of that of other osteopathic physicians; however, it is clearly covered by the Telemedicine Rule and therefore provides a framework for understanding the operation

of the rule and its underlying rationale. Accordingly, the facts which follow are relevant to this proceeding although they cannot and do not provide the competent substantial evidence for the rule. See Conclusions of Law, Part D.5 infra.

3/ The Amended Petition did not allege that the Telemedicine Rule was invalid under Section 120.52(8)(a). However, at the conclusion of the hearing, Petitioner's ore tenus motion to conform the pleadings to the evidence was granted. See Cosmetic Surgery, 808 So. 2d at 256. The effect of that motion was to expand the Amended Petition to include a challenge based upon Section 120.52(8)(a).

4/ Even more recent is the First District's decision in Frandsen v. Dept. of Environmental Protection, 27 Fla. L. Weekly D2039, 2002 WL 31026834 (Fla. 1st DCA Sept. 12, 2002). However,

the opinion in that case focuses on the appellant's constitutional challenge to the rule, and it does not include a detailed analysis of the rule's validity under Section 120.52(8). And see Sierra Club v. St. Johns River Water Management Dist, 816 So. 2d 687 (Fla. 5th DCA 2002) (citing Save the Manatee and concluding that a rule which "tracks" the statute is not invalid under Section 120.52(8)(c)).

5/ The other statute cited by the Board as authority for the Telemedicine Rule is Section 459.005. That statute provides the Board general rulemaking authority and is not, in and of itself, sufficient to support the Telemedicine Rule. See Section 120.52(8), "flush left" paragraph ("A grant of rulemaking authority is necessary but not sufficient to allow an agency to adopt a rule ").

6/ That circumstance is not present in this case. Although there is a passing reference in the transcript of the Board's March 9, 2001, meeting to a unsuccessful legislative effort to address the issue of telemedicine in the 2000 Session, the record does not include any credible evidence confirming the existence of that effort, nor does it include copies of the bills which the Legislature purportedly considered.

7/ Of course, issues related to the application of the Telemedicine Rule to a particular set of circumstances are beyond the scope of this proceeding. See, e.g., Hasper v. Dept. of Administration, 459 So. 2d 398, 400 (Fla. 1st DCA 1984) (Section 120.57 proceeding, not rule challenge is appropriate mechanism to challenge agency's application of its rule).

8/ The court did not specifically limit its comments on the scope of review to Section 120.52(8)(f); however, those comments were in the part of the court's opinion addressing only the competent substantial evidence prong of the challenge in that case and were preceded by the heading "Section 120.52(8)(f)." Accord Blanton, Competent and Substantial Evidence in Rule Challenges: A Standard of Proof or Standard of Review?, Admin

L. Section Newsletter (Sept. 2002).

9/ In light of the records custodian certification which is included as part of Exhibit R1, some of the documents in that exhibit, such as the meeting minutes and perhaps the meeting transcripts, may be admissible under the exceptions in Section 90.803(6) or (8); however, the substance of the remainder of the documents (particularly the FSMB reports) would still be hearsay in this proceeding to the extent that they are considered for their truth. See, e.g., Juste v. Dept. of Health & Rehabilitative Servs., 520 So. 2d 69 (Fla. 1st DCA 1988); Harris v. Game & Fresh Water Fish Comm'n, 495 So. 2d 806 (Fla. 1st DCA 1986).

10/ But cf. Agency for Health Care Admin. v. Fla. Coalition of Professional Laboratory Orgs., 718 So. 2d 869, 871 n.3 (Fla. 1st DCA 1998) (characterizing Section 120.52(8)(f) as imposing an "evidentiary burden"); Board of Clincal Lab. Personnel v.

Florida Ass'n of Blood Banks, 721 So. 2d 317, 318 (Fla. 1st DCA 1998) (holding that burden of proof in rulemaking proceeding is competent substantial evidence, not preponderance of the evidence), superceded by Chapter 99-379, Section 5, Laws of Florida (amending Section 120.56(2)(a) to specifically include preponderance of the evidence as the standard of proof for cases involving challenges to proposed rules).

11/ This characterization is curious because Section 120.56(1)(e) provides that rule challenge hearings "shall be conducted in the same manner as provided in ss. 120.569 and 120.57" and it is well-settled (or at least it was prior to Cosmetic Surgery) that Section 120.57 proceedings are de novo, not just "technically" de novo. See, e.g., McDonald v. Dept. of Banking & Fin., 346 So. 2d 569 (Fla. 1st DCA 1977); Section 120.57(1)(k).

12/ This comparison is also curious because rulemaking is a quasi-legislative function, see, e.g., Adam Smith Enterprises, Inc. v. Dept. of Environmental Regulation, 553 So. 2d 1260, 1269-70 (Fla. 1st DCA 1989), but certiorari is the method used to review quasi-judicial actions not quasi-legislative actions.

See, e.g., Board of County Com'rs of Brevard County v. Snyder, 627 So. 2d 469, 474 (Fla. 1993); Hirt v. Polk County Bd. of

County Com'rs, 578 So. 2d 415, 416 (Fla. 2d DCA 1991). And cf. General Telephone Co. of Florida v. Public Service Comm'n, 446 So. 2d 1063, 1067 (Fla. 1984) ("[The] standard of review for a quasi-legislative proceeding must differ from that for a quasi- judicial proceeding, as a qualitative, quantitative standard such as competent and substantial evidence is conceptually inapplicable to a proceeding where the record was not compiled in an adjudicatory setting and no factual issues were determined.").

13/ The Legislature has since limited the circumstances in which direct review of agency rules is available. See 120.68(9) (direct review is only available where sole issue is constitutionality of the rule and there are no disputed issues of fact) (formerly codified in Section 120.68(15), Florida Statutes (Supp. 1992 through 1995)). In Baillie, supra, the court cited the considerations discussed in Adam Smith as support for its decision to uphold the limitation on direct appeals.

14/ On this issue, it is difficult to see how a determination that competent substantial evidence is a standard of proof rather than a standard of review would result in "the rulemaking process [being] turned on its head" as the court discussed in Cosmetic Surgery, 808 So. 2d at 257. Indeed if a distinction were made between facts "susceptible of proof by ordinary means" and facts "infused with policy considerations" (a distinction which has been well-established in Florida administrative law since McDonald), an appropriate check could be placed on administrative law judges to ensure that they would not "have the final say regarding the wisdom of agency rules." Cosmetic Surgery, 808 So. 2d at 257 (emphasis supplied). In this regard, the following construction of Section 120.52(8)(f) would seem to alleviate the problems identified in Adam Smith and Baillie that result from characterization of the competent substantial evidence language in Section 120.52(8)(f) as a standard of review and, at the same time, give effect to Section 120.56(1)(e) which (by its reference to Sections 120.569 and 120.57) characterizes rule challenges as de novo proceedings and not just "technically de novo":

When an agency has based its proposed rules on factual assumptions which are "susceptible to proof by ordinary means" then, when challenged on its factual

assumptions, the agency has . . . the burden of persuading the administrative law judge [based upon the evidence presented at the de novo rule challenge hearing] that its factual assumptions and conclusions are more likely to be correct than those of the challenger. . . . . On the other hand, when a challenger attacks not the underlying factual assumptions of the agency . . . but rather the policy choice itself, then traditional deferential rules should apply. In such circumstance an administrative law judge . . . should defer to the agency's policy choice, if legally sound . . . .

Bayó and Rimes, Who Goes First and What is "Competent Substantial Evidence" in a Proposed Rule Challenge?, Fla. Bar J., Jan. 1999, at 64. These same principles should apply in a challenge to an existing rule although the burden of proof would be on the challenger rather than the agency. See Conclusions of Law, Part C.

15/ Indeed, while arguing that the Select Committee's April 2000 report is unauthenticated hearsay which would not be admissible in a civil proceeding, Petitioner acknowledges that the report "outlines some justification for curtailing Telemedicine." Petitioner's PFO, at 16.

COPIES FURNISHED:

Edwin A. Bayó, Esquire

Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050

Fred R. Dudley, Esquire

Akerman, Senterfitt & Eidson, P.A.

301 South Bronough Street, Suite 200 Tallahassee, Florida 32301

Stephen Bruce Rakusin, Esquire

1 East Broward Boulevard, Number 1111 Fort Lauderdale, Florida 33301-1865

William H. Buckhalt, Executive Director Board of Osteopathic Medicine Department of Health

4052 Bald Cypress Way, Bin C06 Tallahassee, Florida 32399-1701

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original notice of appeal with the Clerk of the Division of Administrative Hearings and a copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the Appellate District where the party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.

Docket for Case No: 02-002308RX

Orders for Case No: 02-002308RX