02-003116 Marianne Fahle vs. Department Of Management Services, Division Of State Group Insurance Status: Closed Recommended Order on Monday, December 2, 2002.

Summary: Insurance administrator for state group health plan properly denied coverage for chelation therapy for arteriosclerosis as "experimental or investigational" under policy terms.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

MARIANNE FAHLE, )

)

Petitioner, )

)

vs. ) Case No. 02 - 311 6

)

DEPARTMENT OF MANAGEMENT )

SERVICES, DIVISION OF STATE )

GROUP INSURANCE, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was conducted in this

case on October 18, 2002, in Tampa and Tallahassee, Florida, via

video teleconference, before Lawrence P. Stevenson, a duly -

designated Administrative Law Judge of the Di vision of

Administrative Hearings.

APPEARANCES

For Petitioner: Marianne Fahle, pro se

12205 North Marjory Avenue

Tampa, Florida 33612

For Respondent: Julia P. Forrester, Esquire

Department of Management Services

4050 Esplanade Way, Suite 260

Tallahassee, Florida 32399 - 0950

STATEMENT OF THE ISSUE

The issue presented for decision in this case is whether

the Department of Management Services properly denied medical

insurance reimbursement to Marianne Fahle f or EDTA chelation

therapy services provided to her husband, John Fahle.

PRELIMINARY STATEMENT

By letter dated July 17, 2002, the Department of Management

Services, Division of State Group Insurance (the "Department")

notified Petitioner, Marianne Fahle, that it concurred with a

prior decision by its servicing agent, Blue Cross Blue Shield of

Florida, to deny claims for EDTA chelation therapy for her

husband, John Fahle. The Department’s letter stated that the

state group insurance plan denied coverage be cause EDTA

chelation therapy is considered "experimental or

investigational" as those terms are employed by the "State

Employees' PPO Plan Group Health Insurance Plan Booklet and

Benefit Document." By letter dated July 30, 2002, Petitioner

requested a for mal administrative hearing to contest the denial

of benefits. On August 7, 2002, the Department forwarded the

case to the Division of Administrative Hearings for assignment

of an Administrative Law Judge and the conduct of a formal

administrative hearing. The case was scheduled for hearing via

video teleconference on October 18, 2002. The hearing was held

on that date.

At the formal hearing, Petitioner testified on her own

behalf and presented the testimony of Dr. Carol Roberts.

Petitioner's Exhibits 1 through 12 were admitted into evidence.

The Department presented the testimony of Dr. William Wood, an

expert in the practice of medicine and the evaluation of

emerging medical technologies. The Department's Exhibits A

through E were admitted into eviden ce.

No transcript was provided. Both parties timely filed

proposed recommended orders.

FINDINGS OF FACT

Based on the oral and documentary evidence adduced at the

final hearing, and the entire record in this proceeding, the

following findings of fact a re made:

1. Marianne Fahle is a retired employee of the State of

Florida. At all times pertinent to this case, Marianne Fahle

was a participant in the State of Florida group health insurance

plan. Her husband, John Fahle, is a covered dependent.

2. T he state group insurance program is a self - insured

health insurance plan administered for the State of Florida for

its employees by Blue Cross Blue Shield of Florida ("BCBSF").

3. In August 2000, John Fahle was hospitalized after he

collapsed at his hom e. Medical tests revealed that Mr. Fahle

suffered from arteriosclerosis with an estimated 60 - 80%

stenosis, or blockage, of his carotid artery.

4. Rather than undergo surgery to relieve the blockage,

Mr. Fahle chose a course of treatment commonly called EDTA

chelation therapy. Chelation therapy involves the intravenous

injection of ethylene - diamine - tetra acetic acid (edetic acid or

EDTA) accompanied by nutritional supplements.

5. After undergoing chelation therapy, Mr. Fahle's

diagnostic tests were re peated, with reported results indicating

some reduction of the blockage in his coronary artery and a

reduction of the carotid artery blockage to 40 - 60 percent. The

actual tests, as opposed to the physicians' reports of their

results, were not offered as e vidence. The weight of the

evidence established that the reported improvement in Mr.

Fahle's carotid artery blockage, from a 60 - 80 percent blockage

to a 40 - 60 percent blockage, could be attributed to the

subjectivity involved in reading the results of the diagnostic

tests. In any event, the reported improvement was of little

medical significance.

6. Chelation therapy is generally accepted in the medical

community as a safe and efficacious treatment for heavy metal

toxicity, e.g. , lead poisoning. The United States Food and Drug

Administration ("FDA") approved EDTA as a lawfully marketed drug

in 1953. The FDA cannot limit the manner in which a licensed

physician may prescribe an approved drug, though it can place

limits on the marketing representations that may be made as to

the efficaciousness of a drug for certain uses. The FDA has

approved the marketing of EDTA as a treatment for heavy metal

poisoning. The FDA prohibits any person from representing that

chelation therapy is a safe and efficacious t reatment for

arteriosclerosis, though a physician may lawfully treat

arteriosclerosis with chelation therapy.

7. Petitioner submitted several articles attesting to the

value of chelation therapy in treating arteriosclerosis. A

significant minority of p hysicians in the United States employs

chelation therapy as an option in the treatment of

arteriosclerosis. However, reliable, formal clinical trials

have yet to establish the efficacy of chelation therapy as a

standard treatment for arteriosclerosis. Th e strength of the

anecdotal evidence and the persistent advocacy of physicians

have led the National Institute of Health to begin clinical

trials on the use of chelation therapy in the treatment of

arteriosclerosis, but the results of these trials will not be

available for five years.

8. In any event, Mr. Fahle's coverage is determined by the

terms of Ms. Fahle's insurance policy. The terms of coverage

for the state group health insurance plan are set forth in a

document titled, "State Employees' PPO Pla n Group Health

Insurance Plan Booklet and Benefit Document." The benefit

document states, in pertinent part:

Services Not Covered By The Plan

The following services and supplies are

excluded from coverage under this health

insurance plan unless a specif ic exception

is noted. Exceptions may be subject to

certain coverage limitations.

* * *

47. Services and procedures considered by

BCBSF to be experimental or investigational,

or services and procedures not in accordance

with generally accepted profe ssional medical

standards, including complications resulting

from these non - covered services.

9. The benefit document defines "experimental or

investigational services" as follows:

[A]ny evaluation, treatment, therapy or

device that:

* cannot be lawfu lly marketed without

approval of the US Food and Drug

Administration or the Florida Department of

Health if approval for marketing has not

been given at the time the service has been

provided to the covered person

* is the subject of ongoing Phase I or I I

clinical investigation, or the experimental

or research arm of Phase III clinical

investigation -- or is under study to

determine the maximum dosage, toxicity,

safety or efficacy, or to determine the

efficacy compared to standard treatment for

the conditi on

* is generally regarded by experts as

requiring more study to determine maximum

dosage, toxicity, safety or efficacy, or to

determine the efficacy compared to standard

treatment for the condition

* has not been proven safe and effective

for treatme nt of the condition based on the

most recently published medical literature

of the US, Canada or Great Britain using

generally accepted scientific, medical or

public health methodologies or statistical

practices

* is not accepted in consensus by

practici ng doctors as safe and effective for

the condition

* is not regularly used by practicing

doctors to treat patients with the same or

similar condition

BCBSF and [the Department] determine whether

a service or supply is experimental or

investigational.

10. The benefit document is not explicit as to whether the

elements of the quoted definition are to be considered in the

disjunctive, but the plain sense of the document leads to the

reading that if any one of the definitional elements applies,

then the s ervice or supply must be considered experimental or

investigational. Dr. William Wood, BCBSF's medical director,

confirmed that if any single element of the definition applies

to a service or supply, then it is considered experimental or

investigational.

11. Chelation therapy would fall under every element of

the definition except, arguably, the last element dealing with

regular use by practicing physicians. The FDA does not allow

chelation therapy to be marketed as a treatment for

arteriosclerosis, c helation therapy is currently the subject of

clinical trials, and it is not accepted "in consensus" by

practicing physicians as a treatment for arteriosclerosis.

CONCLUSIONS OF LAW

12. The Division of Administrative Hearings has

jurisdiction over the par ties and subject matter of this

proceeding pursuant to Section 120.57(1), Florida Statutes.

13. Exclusions from coverage in insurance policies are to

be strictly construed against the insurer. Comprehensive Health

Association v. Carmichael , 706 So. 2d 3 19, 320 (Fla. 4th DCA

1997).

14. In this case, the policy exclusion is plainly written

and clearly applies to chelation therapy. The Department

correctly upheld the determination by BCBSF that chelation

therapy is an experimental or investigational se rvice and is

thus not reimbursable under the state group health insurance

plan.

RECOMMENDATION

Upon the foregoing findings of fact and conclusions of law,

it is recommended that the Department of Management Services

enter a Final Order dismissing the peti tion of Marianne Fahle.

DONE AND ENTERED this 2nd day of December, 2002, in

Tallahassee, Leon County, Florida.

___________________________________

LAWRENCE P. STEVENSON

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 2nd day of December, 2002.

COPIES FURNISHED :

M arianne Fahle

12205 North Marjory Avenue

Tampa, Florida 33612

Julia Forrester, Esquire

Department of Management Services

4050 Esplanade Way, Suite 260

Tallahassee, Florida 32399 - 0950

John Matthews, Director

Division of State Group Insurance

Department of Management Services

4040 Esplanade Way, Suite 135

Tallahassee, Florida 32399 - 0950

Simone Marstiller, General Counsel

Department of Management Services

4050 Esplanade Way, Suite 260

Tallahassee, Florida 32399 - 0950

NOTICE OF RIGHT TO SUBMIT EXCE PTIONS

All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions

to this recommended order should be filed with the agency that

will issue the final order in this case.