01-000025RP Florida Medical Association, Inc. vs. Department Of Health, Board Of Acupuncture Status: Closed DOAH Final Order on Thursday, August 23, 2001.

Summary: Petitioners, governed by Chapters 458 and 459, Florida Statutes, had no standing to challenge Board of Acupuncture rules defining diagnosis, traditional Chinese medical concepts, and modern Oriental medical techniques, promulgated under Chapter 457.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA MEDICAL ASSOCIATION, )

INC., )

)

Petitioner, )

)

and )

)

THE FLORIDA ACADEMY OF )

PHYSICIANS ASSISTANTS, )

)

Intervenor, )

)

vs. ) Case No. 01-0025RP

)

DEPARTMENT OF HEALTH, BOARD OF )

ACUPUNCTURE, )

)

Respondent, )

)

and )

)

FLORIDA STATE ORIENTAL MEDICAL )

ASSOCIATION, )

)

Intervenor. )

)

FINAL ORDER

This cause came on for final hearing in Tallahassee,

Florida, on May 10, 2001, before Ella Jane P. Davis, a duly-

designated Administrative Law Judge of the Division of

Administrative Hearings.

APPEARANCES

For Petitioner Florida Medical Association, Inc.:

Francesca Plendl, Esquire

John M. Knight, Esquire

Jeffrey M. Scott, Esquire

113 East College Avenue

Tallahassee, Florida 32301

For Respondent Board of Acupuncture:

Barbara Rockill Edwards, Esquire

Assistan t Attorney General

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

For Intervenor, Florida Academy of Physicians Assistants:

Anthony D. Demma, Esquire

Meyer and Brooks, P.A.

2544 Blairstone Pine Drive

Tallahassee, Florida 32301

For Intervenor, Florida State Oriental Medical Association:

Stephen Marc Slepin, Esquire

Slepin and Slepin

1203 Governor's Square Boulevard

Magnolia Centre I, Suite 102

Tallahassee, Florida 32301

STATEMENT OF THE ISSUES

(1 ) Whether the Florida Medical Association and Florida

Association of Physicians Assistants have standing to initiate

this challenge to the proposed rules. (See Section 120.56(3)

Florida Statutes.)

(2 ) Whether proposed Rules 64B1-4.010 and 64B1-4.011,

Florida Administrative Code, constitute invalid exercises of

delegated legislative authority because they exceed the Board of

Acupuncture's rulemaking authority contained in Section 457.104,

Florida Statutes. (See Section 120.52(8)(b), Florida Statutes.)

(3 ) Whether proposed Rules 64B1-4.010 and 64B1-4.011,

Florida Administrative Code, constitute invalid exercises of

delegated legislative authority because they enlarge, modify, or

contravene the provisions of Section 457.102, Florida Statutes.

(See Section 120.52(8)(c), Florida Statutes.)

PRELIMINARY STATEMENT

On January 4, 2001, Petitioner, Florida Medical Association,

Inc. (FMA) filed a Petition seeking to have proposed Rules 64B1-

4.010 and 4.011, declared invalid exercises of delegated

legislative authority by the Board of Acupuncture.

On January 8, 2001, the case was assigned to the

undersigned. Petitions to Intervene by the Florida Academy of

Physicians Assistants (FAPA), on behalf of Petitioner, and by the

Florida State Oriental Medical Association (FSOMA), and by Terry

Brant, on behalf of the Board of Acupuncture (Board) were

granted. Thereafter, Terry Brant withdrew as an intervenor.

After consolidation wi th Florida Medical Ass'n ., Inc., et

al. v. Dept. of Health, Bd. of Acupuncture, et al , DOAH Case

No. 00-4737RX, later bifurcation from that case, the filing of

several Notices of Change, and the granting of several Motions

for Continuance, final hearing was scheduled for May 10, 2001,

upon the rules as finally proposed.

At final hearing, Petitioners presented the testimony of

Steven West. Respondents' oral motions to dismiss at the close

of Petitioners' case was denied, subject to revisitation in this

Final Order.

Respondents presented the testimony of Harvey Kaltsas and

Edwin Moore.

The parties had Joint Exhibit A, constituting the rules as

finally proposed, admitted in evidence.

A Transcript was filed with the Division on May 17, 2001.

The date of July 15, 2001, established for the filing of

proposed orders was not met by all parties, but all parties

waived any objection to late filings. FAPA adopted Petitioner's

Proposed Final Order. All other parties respectively filed

Proposed Final Orders. All proposals have been considered.

FINDINGS OF FACT

1. It was stipulated that Petitioner FMA is organized and

maintained for the benefit of approximately 16,000 licensed

allopathic and osteopathic Florida physicians. FMA's standing in

this proceeding has always been at issue. The foregoing

stipulation encompasses all of the factual allegations about

Petitioner contained in the Petition.

2. Dr. Steven West, an allopathic physician licensed in the

State of Florida pursuant to Chapter 458, Florida Statutes, and a

member of FMA, testified as follows:

Well, we have two interests. Certainly one

interest is that we want to make certain that

only qualified individuals and practitioners

treat patients and diagnose patients because

we have an interest in the health and welfare

of the people of the State of Florida.

Secondly, we have an interest in making

certain that all of the hard work and time

that we have spent in our training remains

valuable and is considered unique and

important. And so we have a concern about

the devaluation of the practice of medicine.

(TR-17)

3. It was stipulated that there is only one Respondent, the

Board of Acupuncture, created by the Florida Legislature and

placed within the Florida Department of Health. It is axiomatic

that Respondent has standing herein.

4. There were no stipulations as to the standing of either

intervenor, and both the Board and FSOMA have asserted in their

respective Proposed Final Orders that FAPA, as well as FMA, is

without standing to bring this rule challenge. However, no party

has contested the veracity of the factual statements concerning

standing in either Petition to Intervene, and no party opposed

intervention. The Petitions to Intervene of FAPA and FSOMA were

granted, subject to proving-up standing at hearing. Even

stipulations as to standing do not preclude consideration of

standing as a matter of law. Florida Medical Ass'n ., Inc., et

al. v. Dept. of Health, Florida Bd. of Nursing, et al. , DOAH

Case No. 99-5337RP (Final Order March 13, 2000), per curiam

affirmed Bd. of Nursing, et al. v. Florida Medical Ass'n., Inc.,

et al , ___So. 2d ___ (Fla. 1st DCA 2001). Therefore, under these

circumstances, and applying that case, the intervenors' factual

allegations for purposes of standing may be taken as true for

findings of fact, but each intervenor's status still depends upon

that of the respective party upon whose behalf each intervenor

entered this case.

5. Therefore, with regard to the status of FAPA, it is

found that:

FAPA is organized and maintained for the

benefit of the licensed Florida physicians

assistants who compromise [sic] its

membership and has as one of its primary

functions to represent the interests of its

members before various governmental entities

of the State of Florida, including the

Department of Health and its boards. (FAPA

Petition to Intervene)

6. Therefore, with regard to the status of FSOMA, it is

found that:

FSOMA is a Florida nonprofit corporation

comprised of over one-third of the doctors of

oriental medicine and licensed acupuncturists

under the regulatory aegis of the Board of

Acupuncture, State of Florida Department of

Health, Chapter 457, F.S., with a mission to

represent the acupuncture and oriental

medicine practitioner interests of its

members in judicial, administrative,

legislative and other proceedings. (FSOMA

Petition to Intervene)

7. The text of proposed Rule 64B1-4.010, set forth in the

petition is no longer correct, because it has been altered by

Notices of Change, pursuant to Chapter 120, Florida Statutes.

Rule 64B1-4.010, as currently proposed, would provide:

Traditional Chinese Medical Concepts, Modern

Oriental Medical Techniques.

Traditional Chinese medical concepts and

modern oriental medical techniques shall

include acupuncture diagnosis and treatment

to prevent or correct malady, illness,

injury, pain, addictions, other conditions,

disorders, and dysfunction of the human body;

to harmonize the flow of Qi or vital force;

to balance the energy and functions of a

patient; and to promote, maintain, and

restore health; for pain management and

palliative care; for acupuncture anesthesia;

and to prevent disease by the use or

administration of: stimulation to acupuncture

points, ah-shi points, auricular points,

channels, collaterals, meridians, and

microsystems which shall include the use of:

akabane; allergy elimination techniques;

breathing; cold; color; correspondence;

cupping; dietary guidelines; electricity;

electroacupuncture; electrodermal screening

(EDS); exercise; eight principles; five

elements; four levels; hara; heat; herbal

therapy consisting of plant, animal, and/or

mineral substances; infrared and other forms

of light; inquiring of history; jing-luo;

listening; moxibustion; needles; NAET;

observation; oriental massage -- manual and

mechanical methods; palpation; physiognomy;

point micro-bleeding therapy; pulses; qi; xue

and jin-ye; ryodoraku; san-jiao; six stages;

smelling; tongue; tai qi; qi gong; wulun-

baguo; yin-yang; zang-fu; Ayurvedic, Chinese,

Japanese, Korean, Manchurian, Mongolian,

Tibetan, Uighurian, Vietnamese, and other

east Asian acupuncture and oriental medical

concepts and treatment techniques; French

acupuncture; German acupuncture including

electroacupuncture and diagnosis; and, the

use of laboratory test and imaging findings .

(Emphasis supplied).

8. The "authority" cited by the Board for proposed Rule

64B1-4.010 is Sections 457.102 and 457.104, Florida Statutes.

9. The Board cites the "law implemented" for Rule 64B1-

4.010 as Section 457.102, Florida Statutes.

10. The text of Rule 64B1-4.011, as set forth in the

petition also is no longer correct, because it has been changed

by Notices of Change, pursuant to Chapter 120, Florida Statutes.

Rule 64B1-4.011, as currently proposed, would provide:

Diagnostic techniques which assist in

acupuncture diagnosis, corroboration and

monitoring of an acupuncture treatment plan

or in making a determination to refer a

patient to other health care providers shall

include: traditional Chinese medical concepts

and modern oriental medical techniques ,

recommendation of home diagnostic screening;

physical examination; use of laboratory test

findings; use of imaging films, reports, or

test findings ; office screening of hair,

saliva and urine; muscle response testing;

palpation; reflex; range of motion, sensory

testing; thermography; trigger points; vital

signs; first-aid; hygiene; and sanitation.

(Emphasis supplied).

11. The "authority" cited by the Board for proposed Rule

64B1-4.011 is Sections 457.102(1) and 457.104, Florida Statutes.

12. The Board cites the "law implemented" for proposed Rule

64B1-4.011 as Section 457.102 (1), Florida Statutes.

13. Section 457.104, Florida Statutes, currently provides:

The board has authority to adopt rules

pursuant to ss. 120.536(1) and 120.54 to

implement provisions of this chapter

conferring duties upon it.

14. Section 457.102, Florida Statutes, currently provides:

(1) "Acupuncture" means a form of primary

health care, based on traditional Chinese

medical concepts and modern oriental medical

techniques, that employs acupuncture

diagnosis and treatment, as well as

adjunctive therapies and diagnostic

techniques , for the promotion, maintenance,

and restoration of health and the prevention

of disease. Acupuncture shall include, but

not be limited to , the insertion of

acupuncture needles and the application of

moxibustion to specific areas of the human

body and the use of electroacupuncture, Qi

Gong, oriental massage, herbal therapy,

dietary guidelines, and other adjunctive

therapies, as defined by board rule .

(2) "Acupuncturist" means any person

licensed as provided in this chapter to

practice acupuncture as a primary health care

provider.

(3) "Board" means the Board of Acupuncture.

(4) "License" means the document of

authorization issued by the department for a

person to engage in the practice of

acupuncture.

(5) "Department" means the Department of

Health.

(6) "Oriental medicine" means the use of

acupuncture, electroacupuncture, Qi Gong,

oriental massage, herbal therapy, dietary

guidelines, and other adjunctive therapies.

(7) "Prescriptive rights" means the

prescription, administration, and use of

needles and devices, restricted devices, and

prescription devices that are used in the

practice of acupuncture and oriental

medicine. (Emphasis supplied)

15. The Board asserts that the use of a comma between

"other adjunctive therapies" and "as defined by board rule" in

the second sentence of Section 457.102(1), Florida Statutes,

establishes that the clause "as defined by board rule" applies to

"the insertion of acupuncture needles and the application of

moxibustion to specific areas of the human body and the use of

electroacupuncture, Qi Gong, oriental massage, herbal therapy,

dietary guidelines, and other adjunctive therapies," and those

practices "included but not listed."

16. Rule 64B1-3.001, Florida Administrative Code, most

recently amended February 27, 1992, addresses "adjunctive

therapies" of acupuncturists as follows:

(3 ) Acupuncture diagnostic techniques shall

include but not be limited to the use of

observation, listening, smelling, inquiring,

palpation, pulses, tongues, physiognomy, five

element correspondence, ryordoraku, akabani,

German electro acupuncture, Kirlian

photography, and thermography. (Emphasis

supplied).

* * *

(5 ) Adjunctive therapies shall include but

not be limited to:

(a ) Nutritional counseling and the

recommendation of nonprescription substances

which meet the Food and Drug Administration

labeling requirements, as dietary supplements

to promote health;

(b ) Recommendation of breathing techniques

and therapeutic exercises; and

(c ) Lifestyle and stress counseling;

(d ) The recommendation of all homeopathic

preparations approved by the Food and Drug

Administration and the United States

Homeopathic Pharmacopeia Committee; and

(e ) Herbology.

This rule has not been challenged. 1

17. Likewise, Rule 64B1-4.008, Florida Administrative Code,

promulgated December 24, 2000, has not been challenged , 2 and

defines "adjunctive therapies," of acupuncturists as follows:

Adjunctive therapies shall include the

stimulation of acupuncture points, ah-shi

points, auricular points, channels,

collaterals, meridians, and microsystems with

the use of: air; aromatherapy; color;

cryotherapy; electric moxibustion;

homeopathy; hyperthermia; ion pumping cords;

iridology; kirlian photography; laser

acupuncture; lifestyle counseling; magnet

therapy; paraffin; photonic stimulation;

recommendation of breathing techniques;

therapeutic exercises and daily activities;

sound including sonopuncture; traction;

water; thermal therapy; and other adjunctive

therapies and diagnostic techniques of

traditional Chinese medical concepts and

modern oriental medical techniques as set

forth in Rule 64B1-4.010 . (Emphasis

supplied).

18. Acupuncturists are, by law, "primary health providers."

Subsections 457.102(1) and (2), Florida Statutes. (See Finding

of Fact 14). A primary health care provider is a professional to

whom patients can go without a referring physician and who, by

diagnosis and treatment, assumes responsibility for patients'

appropriate care. Allopaths and osteopaths are also primary

health care providers.

19. FSOMA asserted that the challenged rules are supported

by Section 457.1085, Florida Statutes, which provides,

457.1085 Infection control--Prior to

November 1, 1986, the board shall adopt rules

relating to the prevention of infection, the

safe disposal of any potentially infectious

materials, and other requirements to protect

the health, safety, and welfare of the

public. Beginning October 1, 1997, all

acupuncture needles that are to be used on a

patient must be sterile and disposable, and

each needle may be used only once.

20. The traditional course of education, training, and

experience for allopathic physicians and osteopathic physicians

involves four years of undergraduate college education, four

years of medical school, one-year internship, and one to two

years of residency, but is more specifically set out for

licensing purposes in Sections 458.311-458.318, Florida Statutes,

for allopaths, and Sections 459.0055-459.008, Florida Statutes,

for osteopaths. All of these courses/periods of learning

involve, to a greater or lesser degree, learning to use and

interpret modern laboratory and imaging tests.

21. The traditional course of education for acupuncturists

involves only two years of college and four years of acupuncture

schooling, but is more specifically set out for licensing

purposes by Section 457.105, Florida Statutes. Four hours per

week for one year is about the extent of training in the use and

interpretation of modern laboratory tests and imaging films

afforded acupuncture students.

22. There clearly are more stringent requirements for

licensure of allopaths and osteopaths than for acupuncturists.

23. Allopaths and osteopaths clearly spend more time

training in the ordering, use, and interpretation of modern

laboratory tests and film imaging.

24. As previously stated (see Finding of Fact 14), an

acupuncturist, as defined by law,

. . . employs acupuncture diagnosis and

treatment, as well as adjunctive therapies

and diagnostic techniques for the promotion,

maintenance, and restoration of health and

the prevention of disease . . .(Emphasis

supplied).

25. Section 458.305(3), Florida Statutes , defines the

"practice of medicine" as

"Practice of medicine" means the diagnosis ,

treatment, operation, or prescription for any

human disease, pain, injury, deformity, or

physical or mental condition. (Emphasis

supplied).

26. Section 459.003(3), Flo rida Statutes, defines the

"practice of osteopathic medicine" as

"Practice of osteopathic medicine means the

diagnosis , treatment, operation, or

prescription for any human disease, pain,

injury, deformity, or other physical or

mental condition, which practice is based in

part upon educational standards and

requirements which emphasize the importance

of the musculoskeletal structure and

manipulative therapy in the maintenance and

restoration of health. (Emphasis supplied).

27. The following statutes express the Legislature's intent

with regard to regulation of acupuncturists, allopaths, and

osteopaths:

457.101 Legislative Intent - The Legislature

finds that the interests of the public health

require the regulation of the practice of

acupuncture in this state for the purpose of

protecting the health, safety, and welfare of

our citizens while making this healing art

available to those who seek it.

458.301 Purpose - The Legislature recognizes

that the practice of medicine is potentially

dangerous to the public if conducted by

unsafe and incompetent practitioners. The

Legislature finds further that it is

difficult for the public to make an informed

choice when selecting a physician and that

the consequences of a wrong decision could

seriously harm the public health and safety.

The primary legislative purpose in enacting

this chapter is to ensure that every

physician practicing in this state meets

minimum requirements for safe practice. It

is the legislative intent that physicians who

fall below minimum competency or who

otherwise present a danger to the public

shall be prohibited from practicing in this

state.

459.001 Purpose - The Legislature recognizes

that the practice of osteopathic medicine is

potentially dangerous to the public if

conducted by unsafe and incompetent

practitioners. The Legislature finds further

that it is difficult for the public to make

an informed choice when selecting an

osteopathic physician and that the

consequences of a wrong decision could

seriously harm the public health and safety.

The primary legislative purpose in enacting

this chapter is to ensure that every

osteopathic physician practicing in this

state meets minimum requirements for safe and

effective practice. It is the legislative

intent that osteopathic physicians who fall

below minimum competency or who otherwise

present a danger to the public shall be

prohibited from practicing in this state.

28. There was competent testimony that allopathic and

osteopathic physicians may utilize acupuncture in the practice of

their professions, as defined respectively at Sections 458.305(3)

and 459.003(3), Florida Statutes. They are permitted to perform

acupuncture, although their traditional course of professional

education and training involves fewer (or no) hours of

acupuncture education and training than are required under

Chapter 457, Florida Statutes, the acupuncture practice Act.

Presumably, that is because their respective professions and the

Legislature have recognized that the training of allopaths and

osteopaths encompasses the appropriate skills for acupuncture.

However, if they perform acupuncture, they can only be

disciplined under their respective practice Acts, Chapters 458

and 459, Florida Statutes. The Board of Acupuncture has no

authority to discipline them.

29. The record is silent as to whether or not Physicians

Assistants, whether FAPA members or not, may legitimately perform

acupuncture.

30. To "practice medicine" or to "practice osteopathic

medicine," as those terms have been respectively defined by

Sections 458.305(3) and 459.003(3), Florida Statutes, do not

render modern laboratory tests and imaging films unique to

medical or osteopathic diagnosis.

31. However, Harvey Kaltsas, a Florida-licensed

acupuncturist and a member of the Board of Acupuncture, testified

that "traditional Chinese medical concepts," and "modern oriental

medical techniques" include gynecological and obstetric services,

abortions, and cut-and-stitch surgery and that these services are

performed by acupuncturists in China today. He further testified

that the Board of Acupuncture believed that these tasks are

"better handled" by allopathic physicians, and therefore the

Board of Acupuncture has promulgated rules (most particularly the

unchallenged rules addressing adjunctive therapies) which do not

list these services. The Board believed that by not listing

these services, it was prohibiting its licensees from performing

them.

32. The Board further asserts that its challenged rules

only define "traditional Chinese medical concepts" and "modern

oriental medical techniques" as used in Chapter 457, Florida

Statutes, to include the use of laboratory tests and imaging

findings and to clearly specify that "diagnostic techniques" for

acupuncturists also include the use of modern laboratory test

findings, and use of imaging films, reports, and test findings.

33. There was competent testimony that modern laboratory

Chinese medical tests on urine and feces evolved from ancient and

traditional concepts and are regularly used in China and the

orient by acupuncturists today. There was competent testimony

that comparison of x-rays, at least for gross chest problems or

for placement of acupuncture needles, is taught in an acupuncture

college in Florida as part of its usual and required curriculum

today.

34. Allopaths and osteopaths use laboratory tests, imaging

films, and reports thereon to reach an initial diagnosis and to

test and revise that diagnosis through a course of treatment.

35. Dr. West testified that he relies on his own "reading"

of x-rays for his specialty of cardiology, while other allopaths

may rely on a radiologist to read x-rays for them or may rely on

a radiology report.

36. Diagnosis is also a part of acupuncture.

Acupuncturists want to use modern laboratory tests and imaging

films to reach an initial diagnosis and to test that diagnosis

through a course of treatment. They want to use laboratory tests

and film imaging to properly direct their own initial treatment

efforts, such as using urinalysis to eliminate a urinary tract

infection before treating muscles and bones for a backache. They

want to determine blood clotting speeds via an INR test on

persons presenting with a prescriptive history of blood-thinner

use, such as Coumadin, before using acupuncture needles. They

want to be able to eliminate conditions they do not feel

competent to treat, i.e. cancer, and to properly refer those

patients for treatment by allopaths and osteopaths.

37. Modern laboratory test results are variously formatted,

sometimes as a report or value and result. X-rays are frequently

the subject of a narrative report from a radiologist.

38. Some modern imaging results are available directly to

the public, like mobile TB screenings.

CONCLUSIONS OF LAW

39. The Division of Administrative Hearin gs has

jurisdiction of this cause and the parties hereto, pursuant to

Section 120.56(3), Florida Statutes.

40. Petitioner FMA's Proposed Final Order asserts as

grounds for its "substantial interest," and thus for its

"standing" (see Section 120.56, Florida Statutes), that

"acupuncturists have not been given the statutory authority to

use laboratory testing--such remains the exclusive realm of

physicians licensed under Chapters 458 and 459. The Board's

impermissible intrusion into an area of medical practice reserved

for physicians confers standing on FMA to challenge the rule."

FAPA adopts this reasoning.

41. Petitioners assert, further, that since Section

457.102(1), Florida Statutes, defines "acupuncture" as "a form of

primary health care, based on traditional Chinese medical

concepts and modern oriental medical techniques , that employs

acupuncture diagnosis and treatment, as well as adjunctive

therapies and diagnostic techniques , for the promotion,

maintenance and restoration of health and the prevention of

disease," the rules challenged are invalid because they attempt

to define, by rule, the underlined terms contained in the

statute. The thrust of Petitioners' argument is in opposition to

acupuncturists being permitted to order and read laboratory test

findings and use imaging films, reports, and test findings,

including, but not limited to, x-rays.

42. It is further asserted that the challenged rule is

invalid, pursuant to Section 120.56(3), Florida Statutes, because

only the Legislature may promulgate the content of the challenged

rules; because they exceed the Board's rulemaking authority as

provided in Section 457.102, Florida Statutes, which confers no

duties upon the Board; and because they enlarge, modify and

contravene the provisions of Section 457.104, Florida Statutes. 3

43. In the parties' Joint Prehearing Stipulation, they

agreed that "Petitioner has the burden of going forward with

evidence sufficient to make out a legitimate basis for

invalidation of the rules as an invalid exercise of delegated

legislative authority as that standard is defined in Section

120.52(8)(b) or (c)"; and that "if Petitioner succeeds, the

Respondent has the burden of persuasion that the challenges are

factually or legally unsound." However, Section 120.56(2)(a),

Florida Statutes, provides that "[t ]he petitioner has the burden

of going forward. The agency then has the burden to prove by a

preponderance of the evidence that the proposed rule is not an

invalid exercise of delegated legislative authority as to the

objections raised." Therefore, if the merits of the instant

challenge to proposed Rules 64B1-4.010 and 64B1-4.011, may be

reached, the statutory burden placed on the Board is heavier than

stipulated by the parties. However, before the merits may be

addressed, the threshold of "standing" must be crossed.

44. Standing of Respondent is axiomatic. (See Finding of

Fact 3) Standing of FSOMA is clearly established, in that all of

its membership is affected by the rule and subject to discipline

by the Board. (See Finding of Fact 6.)

45. In examining FMA's and FAPA's "standing" herein, there

is no issue concerning their statuses as professional

associations. The law is well-settled that duly-constituted

professional associations constitute "persons" who may challenge

existing and proposed rules. What is at issue is whether these

professional associations have standing in relationship to the

rule challenged.

46. "Acupuncture" is a form of primary health care as

broadly described within Section 457.102 (1), Florida Statutes,

and subject to and "as defined by board rule."

47. Section 457.102(2), Florida Statutes, defines an

"acupuncturist" as a person licensed as provided in Chapter 457,

Florida Statutes, to practice acupuncture as a primary health

care provider.

48. Section 457.118, Florida Statutes, prohibits Chapter

457, Florida Statutes, which relates to, and governs, the

practice of acupuncture, from being construed so as to expand or

limit the scope of any health care professional licensed under

either Chapter 458 or Chapter 459, Florida Statutes , "as such

scope of practice is defined by statute or rule."

50. "Physician assistants" are governed by Chapters 458 and

459, Florida Statutes. Sections 458.347 and 459.022, Florida

Statutes .

51. Allopathic physicians are licensed under, and governed

by, Chapter 458, Florida Statutes, which only recognizes the term

"physicians." Section 458.305(4), Florida Statutes . Allopathic

physicians are regulated by the Board of Medicine. Sections

458.305(1) and (4) and 458.307, Florida Statutes. Chapter 458,

Florida Statutes, exempts them from regulation by any other

professional statutory scheme, including but not limited to the

Board of Acupuncture; Chapter 457, Florida Statutes; and rules

promulgated thereunder. Section 458.303, Florida Statutes.

52. Osteopathic physicians, are licensed under, and

governed by, Chapter 459, Florida Statutes. They are regulated

by the Board of Osteopathic Medicine. Sections 459.003(1) and

(4) and 459.004, Florida Statutes. That statutory scheme exempts

them from regulation by any other professional statutory scheme,

including but not limited to the Board of Acupuncture; Chapter

457, Florida Statutes; and rules promulgated thereunder. Section

459.002, Florida Statutes.

53. No license d Florida "physician," defined at Section

458.305(4), Florida Statutes, as one governed by that Chapter and

the Board of Medicine, is governed by the challenged rules. No

licensed Florida "osteopathic physician", defined at Section

459.003(4), Florida Statutes, is governed by the challenged

rules. No physicians assistant, permitted at Sections 458.347

and 459.022, Florida Statutes, is governed by the challenged

rules; and no stipulated member of FMA is governed by the

challenged rules.

54. Although it was stipulated that FMA is organized and

maintained for the benefit of member allopaths and osteopaths,

there is no evidence to the effect that either profession, as

defined and regulated by Chapters 458 or 459, Florida Statutes,

respectively, is in any way impacted-upon by the challenged

rules. There also is no evidence that physicians assistants, be

they members of FAPA or not, are impacted by the rules. Indeed,

these professions are insulated from any direct imposition of the

rules by Chapters 457, 458, and 459, Florida Statutes.

55. Upon the facts of this case, it remains problematic

whether allopaths and osteopaths are more highly skilled at

acupuncture than acupuncturists, and there is no evidence that

physicians assistants have any training or skill in acupuncture.

Assuming, arguendo , that FMA's assertion in its Proposed Final

Order is correct that "[w ]ithout a doubt, allopathic physicians

receive a higher level of training than do acupuncturists," that

distinction lacks significance where different licensing statutes

are concerned.

56. The evolution of the case law on standing must be

examined with regard to FMA's and FAPA's relationship to the

rules now challenged.

57. In Florida Medical Ass'n, Inc., et al. v. Dept. of

Professional Regulation, Bd. of Optometry, et al. , 426 So. 2d

1112 (Fla. 1st DCA 1983), a determination that FMA had standing

was predicated on "economic injury" to physicians (particularly

ophthalmologists) licensed under Chapter 458, Florida Statutes,

by a rule permitting optometrists, licensed under Chapter 463,

Florida Statutes , to provide treatment involving prescription and

use of "legend (or scheduled) drugs" to patients who otherwise

would be required to obtain such treatment from physicians.

"Standing" then required a showing that (1) Petitioner would

suffer injury in fact of sufficient immediacy to entitle it to

hearing, and that (2) Petitioner's substantial injury was of the

type or nature the proceeding was designed to protect in

challenging the proposed rule. In short, the proposed rule

had to be within the "zone of interest" of physicians licensed

under other statutes in order for them to have standing.

Therein, however, individual members of the petitioner

professional association piggybacked the association regarding

"the right to practice medicine as a valuable property right,

protected by the due process clause." Although commenting

that FMA had no legally recognized interest in being free

from competition, that opinion deliberately left unanswered

the question of whether or not a sufficient injury to support

"standing" is shown by claims that the rule in question will

have the effect of lessening the professional respect and esteem

of physicians in the public eye. It also opened the door to

consider the Constitution and other statutes beyond the several

professional practice Acts when determining standing. The case,

when tried on the merits, resulted in invalidation of the

challenged Board of Optometry rule, and the appellate decision

contains language, later receded from, to the effect that

standing may be affected by the correctness of the challenger's

position on the merits. Bd. of Optometry v. Florida Medical

Ass'n ., Inc., et al. , 463 So. 2d 1213 (Fla. 1st DCA 1985), pet .

rev. denied 475 So. 2d 693 (Fla. 1985).

58. In Bd. of Optometry v. Florida Soc. of Ophthalmology,

538 So. 2d 878 (Fla. 1st DCA 1989), the First District Court of

Appeal reversed a finding of standing it had declared existed in

Florida Soc. of Ophthalmology; Florida Medical Ass'n ., Inc., et

al. v. Bd. of Optometry , 532 So. 2d 1279, (Fla. 1st DCA 1988).

Reviewing some explicit and helpful findings of fact made by the

hearing officer, the court specifically made a lack of standing

determination against FMA's and the Society of Ophthalmology's

assertion that they were "authorized to represent their patients'

rights," thus rejecting a trend toward "Good Samaritan" standing

on behalf of patients or the public at large by professional

associations. The court also clearly ruled that it was legally

insufficient to predicate standing solely upon the basis of

overlapping health care practices or a continuing general

interest in the quality of care to the public and mutual

patients. Rather, direct injury in fact or of sufficient

immediacy and reality to petitioners had to be demonstrated.

Moreover, because the challengers were not subject to the rule,

they could not predicate standing on the notion that the

application of the challenged rule would prevent or obstruct

their own professional practices. The case also clearly held

that standing is not predicated on a challenger's ability to

prevail on the merits of the rule challenge, and foreshadowed the

later holdings that mere economic interest or loss for the

challenger as a result of the rule is insufficient to invoke

standing in a rule challenge and that persons not subject to a

rule have no standing to challenge that rule unless standing is

somehow devolved from a statute providing "exclusive territory"

to the challenger. 4

59. Herein, except for the speculation that use of modern

diagnostic techniques by acupuncturists will "diminish (devalue)

the additional (education, training, and experience) time and

capital expended by allopathic physicians" (material in

parentheses has been inferred by the undersigned), FMA has only

directly alleged a "Good Samaritan" argument of wanting the best

diagnosis and treatment for Florida citizens. Petitioners also

asserted that a technical deficiency based on the differences in

training of acupuncturists exists as to acupuncturists' ability

to order, use, and interpret modern laboratory tests and imaging

films, and therefore, potential harm exists as to patients, but

this was not demonstrated.

60. In 1993, the Florida Optometric Association challenged

a rule of the Board of Medicine. The Board filed a motion to

dismiss the association, alleging that it lacked standing to

challenge a rule of the Board of Medicine. The association was

dismissed, and that dismissal was affirmed purely because the

challengers (optometrists, their association, and a nurses'

association) were not regulated by, or subject to, rules of, or

discipline by, the Board of Medicine. Florida Bd. of Optometry

v. Florida Bd. of Medicine, 616 So. 2d 581 (Fla. 1st DCA 1993).

Herein, the Board of Acupuncture, joined by FSOMA, urges this

very narrow interpretation of the standing necessary to challenge

any of its rules, including Rules 64B1-4.010 and

64B1-4.011, here at bar. They assert that only acupuncturists

may legally challenge a Board of Acupuncture rule.

61. Both proponents and opponents of the rules challenged

herein have cited Dept. of Professional Regulation, Bd. of

Dentistry v. Florida Dental Hygienist Ass'n ., Inc. , 612 So. 2d

646 (Fla. 1st DCA 1993), and the recent case of Florida Medical

Ass'n ., Inc. v. Bd. of Podiatric Medicine , DOAH Case

No. 99-4167RP, (Final Order December 30, 1999), reversed in part

in Bd. of Podiatric Medicine v. Florida Medical Ass'n., Inc. , 779

So. 2d 658 (Fla. 1st DCA 2001). These cases and Florida Medical

Ass'n ., Inc., et al. v. Dept. of Health, Florida Bd. of Nursing ,

DOAH Case No. 99-5337RP, cited supra ., Finding of

Fact 4, are worthy of some discussion at this point. Together,

they present some fine distinctions sufficient to resolve the

issue of standing in the instant case.

62. The Florida Dental Hygienist Ass'n, Inc. , case involved

a challenge by dental hygienists to a proposed rule which would

have allowed dental hygienists with less educational training

(based on the incorporation of a category of dental hygiene

schools into the licensing Act) to apply for licensing in

Florida. The court held,

By allowing unqualified persons to enter

the field, the proposed rule changes tend to

diminish the value of the additional time and

capital expended by the hygienists in order

to meet the higher educational and training

standards required under existing law. Thus,

those hygienists who are already qualified,

licensed and practicing in Florida have a

sufficient interest in maintaining the levels

of education and competence required for

licensing to afford them standing to

challenge an unauthorized encroachment upon

their practice.

63. The dental hygienists case is distinguishable from the

one at bar for a number of reasons. First, it differs

significantly because therein, the challenging dental hygienists

were licensed by, and subject to discipline by, the same Board as

had promulgated the rule, and the challenging dental hygienists

were already licensed and practicing in Florida. Their concern

was with the integrity of their own profession and licenses under

existing law, versus changes to be effected by the proposed rule.

Also, the First District Court of Appeal stated most emphatically

therein that economic interest is not sufficient to confer

standing of third parties (persons outside the practice Act)

unless a statute contemplates consideration of such interests.

Therein, the dental hygienists were found to have standing to

challenge the rule because the challenged rule would have the

effect of opening their profession of dental hygiene to persons

of lesser qualifications. Likewise, the court took into

consideration that dental hygienists were employed almost

exclusively by dentists and therefore the majority of dental

hygienists were subject to dentists' employment control.

Dentists were also licensed and subject to discipline by the same

Board as had promulgated the challenged rule. Under these

circumstances, the dental hygienists who were already licensed

were "substantially affected" by the rule.

64. Herein, there was no showing that any member of FMA or

FAPA is already a licensed acupuncturist or otherwise subject to

the Board of Acupuncture which promulgated this rule.

65. On the merits, the Final Order in Florida Medical

Ass'n ., Inc., et al. v. Dept of Health, Florida Bd. of Nursing,

et al. , DOAH Case No. 99-5337RP, supra. , determined that the

legend drugs prescription statute precluded a Board of Nursing

rule which would have permitted Advanced Registered Nurse

Practitioners to prescribe legend drugs. In determining that FMA

and other petitioners not subject to the Board of Nursing's rules

or discipline had standing to challenge the rule, the

Administrative Law Judge considered the rule challenged, the

challenged rule in relation to the statutes applicable to the

challenging physicians, the challenged rule in relation to the

statutes applicable to the Board of Nursing, and the challenged

rule in relation to independent statutes dealing specifically

with the subject matter of legend drugs. Having done so, he

determined that FMA had standing to challenge the Board of

Nursing rule, despite the different practice Acts applying to

nurses, allopaths, and osteopaths, because the several practice

Acts and the challenged rule itself contemplated a role of

oversight of Advanced Registered Nurse Practitioners by both

allopathic and osteopathic physicians and this oversight role was

both real and immediate. His approach is analogous to the dental

hygienists case, and likewise distinguishable from the case at

bar. Herein, no statute of "exclusive territory" (such as the

legend drug statute) has been shown to contemplate standing by

allopaths, osteopaths, physicians assistants, FMA, or FAPA.

Neither association, nor any member thereof, has an exclusive

right to diagnose or to use modern laboratory tests, film

imaging, or reports, and none of those professions has an

oversight role as to acupuncturists.

66. In Florida Medical Ass'n ., Inc. v. Bd. of Podiatric

Medicine , DOAH Case No. 99-4167RP, (Final Order December 30,

1999), reversed on the merits in Bd. of Podiatric Medicine v.

Florida Medical Ass'n., Inc. , 779 So. 2d 658 (Fla. 1st DCA 2001),

the Administrative Law Judge determined that FMA had standing to

challenge a proposed rule of the Board of Podiatric Medicine

because the definition within the proposed rule expanded

podiatrists' scope of practice into an area of the human leg

reserved exclusively for allopathic and osteopathic physicians.

The Final Order invalidated the proposed rule. On appeal, the

First District Court of Appeal reversed the Final Order's

determination on the merits by holding that the proposed rule was

valid. The decision did not discuss the standing issue, which

FMA and FAPA assert herein had been extensively briefed before

that appellate court. FMA and FAPA further assert that by its

silence on the standing issue, the First District Court of Appeal

implicitly acquiesced in the Administrative Law Judge's

conclusion that FMA had standing to challenge the rules of a

Board which does not regulate members of the association, and

that same should be the grounds of determining Petitioners'

standing in the instant case.

67. The undersigned does not concur. There is no standard

of case interpretation that permits the inference that

Petitioners assert. Also, it was reasonable to suppose that

until the Board of Podiatry rule defining "leg" expanded the

statutory definition thereof from the area strictly below the

knee to include the area above the knee, the area above the knee

was, by law, the exclusive statutory territory of allopaths and

osteopaths. Certainly, the Administrative Law Judge in that case

saw a distinction between the concept of an "exclusive statutory

territory" of allopaths and osteopaths based on what was not

included in the podiatry statute's bounds of podiatry practice,

which concept previous courts have used to uphold challengers'

standing, and the concept of mere overlapping of the traditional

practice of medicine into a body part also treated by another

type of health care provider, such as a leg or an eye, which

latter concept previous courts have ruled will not support

standing to challenge a rule. However, that distinction

apparently did not sway the appellate court on the merits, and

that distinction simply does not exist in the case at bar. No

"exclusive territory" as to statute or as to the words,

"laboratory test findings; use of imaging films, reports or test

findings" has been shown herein.

68. Speculative economic loss alone will not create

standing, and although the case law leaves open the possibility

that loss of esteem in the eyes of the public for allopaths and

osteopaths if more professions are permitted to order, use, and

interpret modern health care laboratory tests, reports and

imaging films may be considered in relationship to the standing

issue, that theory is too remote. Moreover, "loss of esteem"

based on the authority to use diagnostic tools is premised on

conjecture and does not constitute a real or immediate injury in

fact. It is, if anything, in the nature of limiting competition.

Although the effect or impact of the challenged rules themselves

and of the challenged rules in relation to other statutes may be

considered in determining standing, that has been done here and

is not helpful to Petitioners. A demonstration of overlapping

practices based solely on body parts or patients will not support

a finding of standing. Neither challenger nor their respective

memberships are subject in any way to the challenged rules; the

rules contemplate no involvement or oversight by either

challenger of any acupuncturist or of acupuncturists over them.

The challengers have alleged a proprietary or exclusive interest

in the words, "diagnosis," "laboratory tests," "reports," and

"imaging films," and all permutations thereof, but they have

pointed to no statute(s) or rules which define or limit

procedures which allopaths, osteopaths, or acupuncturists may use

for diagnosis which might support that theory. Likewise,

Petitioners have pointed to no statute that currently confers or

formerly conferred an area of practice exclusive to themselves

which these rules invade.

69. In reaching the foregoing legal conclusion, the

undersigned has compared Section 457.102(1), permitting

acupuncturists to diagnose, Section 458.305(3), permitting

allopaths to diagnose, and Section 459.003(3), permitting

osteopaths to diagnose (see Findings of Fact 24-26), has compared

unchallenged rules permitting acupuncturists to use other methods

of diagnosis (see Findings of Fact 16-17), and has gone so far as

to compare the Legislative intents and purposes expressed in the

respective statutes. (See Finding of Fact 27.) None of these

comparisons suggests that diagnosis by way of modern laboratory

tests, reports, and imaging films is exclusive to any particular

practice Act and or that exclusivity of diagnosis methods has

been reserved by the Legislature to any profession.

70. Under the controlling case law, standing cannot exist

on any theory that the challengers derive standing from

representation of their patients, potential patients, or patients

mutual to acupuncturists. In so saying, the undersigned has not

overlooked the possibility of a continuum of care being provided

by allopaths and osteopaths for persons previously mistreated by

another health care professional, which theory was discussed by

the Administrative Law Judge in the podiatrists' case. Herein,

the limited evidence suggests that the proposed rules would

encourage referrals by acupuncturists to allopaths and

osteopaths, but a continuum of care concept is speculative at

best and does not equate with "oversight." There just is no

evidence herein to find that mistreatment of patients by

acupuncturists will now occur as a result of these proposed

rules.

71. FMA and FAPA have not borne their burden to establish

standing to challenge the proposed rules. Having made this

determination, it is not necessary to address the validity, vel

non , of the rules themselves.

ORDER

Petitioner, Florida Medical Association, Inc., and

Intervenor, Florida Association of Physicians Assistants, are

without standing to challenge proposed Rules 64B1-4.010 and 64B1-

4.011, Florida Administrative Code, and the challenges are

accordingly dismissed.

DONE AND ORDERED this 23r d day of August, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

ELLA JANE P. DAVIS

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 [phone]

www.doah.state.fl.us

Filed with Clerk of the

Division of Administrative Hearings

this 23rd day of August, 2001.

ENDNOTES

1/ Originally, this rule was challenged in its entirety, but the

parameters of the challenge in Florida Medical Ass'n., Inc., et

al. v. Dept. of Health, Bd. of Acupuncture, et al. , DOAH Case No.

00-4737RX, were ultimately limited by these same parties to

subsection (6).

2/ At hearing, Petitioners limited themselves to challenging the

invalidity of the language emphasized in Findings of Facts 7 and

10, dealing with the use of laboratory tests, film imaging, and

reports thereon, specifically announcing that no challenge was

being made to the rules defining "adjunctive therapies." (TR-42,

45-47). Indeed, Petitioner affirmatively assert that Section

457.102, Florida Statutes, permits the Board of Acupuncture to

define by rule what adjunctive therapies are included in the

definition of acupuncture. (FMA Proposed Final Order page 5).

See also the Joint Prehearing Stipulation and the Conclusions of

Law.

3/ It is probable Petitioner FMA inadvertently reversed these

statutory cites.

4/ Prior to this case, the prescription of legend drugs had been

limited to allopathic and osteopathic physicians, within whose

practice Acts the ophthalmologists whom FMA and the Society

represented operated their practices. However, in the referenced

case, the challenged rule was promulgated to implement a new

statutory amendment permitting optometrists to use legend drugs.

COPIES FURNISHED :

William H. Buckhalt, Executive Director

Board of Acupuncture

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Anthony D. Demma, Esquire

Meyer & Brooks, P.A.

2544 Blairstone Pines Drive

Post Office Box 1547

Tallahassee, Florida 32302

Barbara Rockhill Edwards, Esquire

Department of Legal Affairs

The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

Francesca Plendl, Esquire

John M. Knight, Esquire

Jeffrey M. Scott, Esquire

113 East College Avenue

Tallahassee, Florida 32301

Stephen Marc Slepin, Esquire

Slepin and Slepin

1203 Governor's Square Boulevard

Magnolia Centre I, Suite 102

Tallahassee, Florida 32301-2684

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 one copy of

a notice of appeal with the Clerk of the Division of

Administrative Hearings and a second 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.