20-000146 Abolghasem Zolfaghari vs. Department Of Management Services, Division Of State Group Insurance Status: Closed Recommended Order on Monday, May 4, 2020.

Summary: Petitioner failed to prove proton beam therapy, an experimental and/or investigational treatment, was ?medically necessary? when IMRT, an equally effective treatment, was available and approved by Respondent.

S TATE OF F LORIDA

D IVISION OF A DMINISTRATIVE H EARINGS

A BOLGHASEM Z OLFAGHARI ,

Petitioner

and

M IAMI C ANCER I NSTITUTE A T B APTIST

H EALTH , I NC . ,

Intervenor ,

vs. Case No. 20 - 0146

D EPARTMENT OF M ANAGEMENT S ERVICES ,

D IVISION OF S TATE G ROUP I NSURANCE ,

Respon dent .

/

R ECOMMENDED O RDER

Pursuant to notice, a formal administrative hearing was conducted before

Administrative Law Judge Robert S. Cohen of the Division of Administrative

Hearings ( Ñ DOAH Ò ) on March 9, 2020, by video teleconference at sites located

in Miami and Tallahassee, Florida.

A PPEARANCES

For Petitioner: Abolghasem Zolfaghari , pro se

10910 Southwest 140th Avenue

Miami, Florida 33186

For Intervenor: Frank A. Florio, Esquire

Maria D. Garcia, Esquire

Kozyak, Tropin & Throckmorton, LLP

2525 Ponce de Leon Boulevard, Ninth Floor

Coral Gables, Florida 33134

For Respondent: Erica D. Moore, Esquire

Thomas E. Wright, Esquire

Department of Management Service s

4050 Esplanade Way, Suite 160

Tallahassee, Florida 32399

S TATEMENT OF T HE I SSUE

Whether PetitionerÔs request for coverage of p roton b eam r adiation

t herapy ( Ñproton beam therapyÒ or Ñ PBRT Ò ) is a covered benefit pursuant to

the State EmployeesÔ Health Maintenance Organization (Ñ HMO Ò) Plan

(ÑPlanÒ) , administered by AvMed.

P RELIMINARY S TATEMENT

Petitioner is a member of the Plan , administered by AvMed , as a retiree

of the State of Florida. Pet itioner was diagnosed with prostate cancer and

sought preservice authorization of PBRT at the Miami Cancer Institute at

Baptist Health , Inc. (ÑMiami Cancer InstituteÒ), in July 2019. On

November 21, 2019, Respondent issued a Level II Appeal Determination

l etter, denying coverage because PBRT Ñis not an approved treatment option

for prostate cancer and is not a covered benefit under the memberÔs plan.Ò On

December 19, 2019, Petitioner appealed and filed a p etition for

a dministrative h earing. On February 26, 2020, the Miami Cancer Institute

mo ved to intervene as the Provider. The Motion was granted on February 27,

2020.

On March 9, 2020, the final hearing was held. Petitioner testified on his

own behalf , and Intervenor presented the testimony of PetitionerÔs wife,

Michelle Zolfaghari , and Maria - Amelia Rodrigues, M.D., PetitionerÔs treating

r adiation o ncologist at Miami Cancer Institute. Respondent presented the

testimony of Sri Gorty, M.D., r adi ation o ncologist for Magellan Healthcare ,

an i ndependent r eviewer for AvMed ; Edwin Rodriguez, M.D., s enior m edical

d irector at AvMed ; Carol Cardoba, c laims a nalyst at AvMed ; and

Dearline Thomas - Brown, R.N., l egal n urse c oordinator for Respondent ,

Department of Management Services, Division of State Group Insurance .

Petit ionerÔs E xhibits A through BB were admitted into evidence without

objection . RespondentÔs E xhibits 1 through 16 were admitted into evidence

without objection . RespondentÔs Motion for Official Recognition was granted,

recognizing sections 110.123 and 110.16 1, Florida Statutes (2019), and the

IRS Cafeteria Plan under 26 U.S.C . § 125.

A two - volume transcript was filed with DOAH on April 2, 2020. The

parties (Petitioner joined in IntervenorÔs post - hearing submission) thereafter

timely filed proposed recommende d orders on April 13, 2020. Both proposed

orders have been duly considered in the preparation of this Recommended

Order.

All references to the Florida Statutes are to the 2019 version, unless

otherwise specified.

F INDINGS OF F ACT

1. Respondent is the sta te agency charged with administering the state

employee health insurance program pursuant to section 110.123.

2. At all times material hereto, Petitioner was a member of the Plan.

AvMed is the third - party administrator for the Plan at issue in this cause. As

the third - party administrator, AvMed provides claims processing, utilization,

and benefit management services. The applicable benefit document is the

State EmployeesÔ HMO Plan, Group Health Insurance Plan Booklet and

Benefits Document (ÑPlan DocumentÒ) , effective January 1, 2019.

3. Petitioner is a 66 - year - old male who was diagnosed with prostate

cancer in November 2017 and underwent a prostatectomy to remove his

prostate on April 12, 2018. Subsequent to his initial surgery and treatment,

Petitioner e xperienced increasing prostate specific antigen ( Ñ PSA Ò ) in three

follow - up tests. His prostate cancer had returned.

4. Petitioner Ôs physician sought to treat his condition with PBRT, a form

of external beam radiation utilizing protons , rather than traditio nal i ntensity

m odulated r adiation t herapy ( Ñ IMRT Ò ) , which is , without question, covered

under the Plan. Medicare, a federal health care insurance program, agreed to

pay 80 percent of IntervenorÔs charges for PBRT, leaving Petitioner

responsible for the rema ining 20 percent being sought to be paid by

PetitionerÔs Plan.

5. On July 3, 2019, Petitioner, through his health care provider,

Maria - Amelia R odrigues, M.D., and Intervenor, Miami Cancer Institute,

submitted a request for coverage of PBRT to AvMed.

6. On J uly 10, 2019, AvMed denied the preservice request for coverage on

the basis that the therapy was experimental/investigational and , therefore,

not medically necessary treatment for the memberÔs condition. The request

was reviewed by Sri Gorty, M.D., a cons ultant r adi ation o ncologist at

Magellan Health care , which is under contract with AvMed.

7. On July 23, 2019, Petitioner submitted a request for a Level I appeal to

AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant

r adiology o ncologist at Dane Street , which is under contract with AvMed . He

filed a report dated August 19, 2019.

8. On August 20, 2019, AvMed denied the request for Level I appeal on

the basis that the therapy was experimental/investigational and, therefore,

not a medically necessary treatment.

9. On November 19, 2019, Petitioner submitted a request for an

ÑExpeditedÒ Level II appeal to Respondent. The Level II appeal was reviewed

by Dearline Thomas - Brown, a r egistered n urse and Level II a ppeal

c oordinator for Respondent.

1 0. On November 21, 2019, Respondent denied PetitionerÔs Level II a ppeal

on the basis that the therapy is experimental/investigational and, therefore,

not medically necessary for treatment of the memberÔs condition.

11. Pursuant to the Plan Document, the Plan pays its share of the cost of

covered services , if the services are:

a. Ordered by a Network Provider (a provider who

is in AvMedÔs network);

b. Considered Medically Necessary for the covered

personÔs treatment because of accident, illness,

conditio n or mental health or nervous disorder;

c. Not specifically limited or excluded under this

Plan; and

d. Rendered while this P lan is in effect.

12. Pursuant to the Plan Document, Section I. Introduction :

The Plan is not intended to and does not cover o r

provide any Medical Services or benefits that are

not Medically Necessary for the diagnosis and

treatment of the Health Plan Member. AvMed

determines whether the services are Medically

Necessary on the basis of terms, conditions, and

criteria established by the Plan as interpreted by

the state, and as set forth in medical guidelines.

13. This chart provides a description of services and supplies covered

under the Plan. Coverage Access Rules are specified under the Plan as

follows:

Cancer Services

Diag nosis and Treatment

Includes both inpatient and outpatient diagnostic

tests and treatment (including anti - cancer

medications administered by Network providers),

including cancer clinical trials as set forth in the

Florida Clinical Trial Compact. Does not include

Experimental or Investigational Treatment.

14. I n order to be a covered benefit, the treatment must be Ñmedically

necessary , Ò not Ñexperimental or investigational , Ò and it must not be

specifically excluded by the Plan.

15. ÑMedically NecessaryÒ i s defined as follows:

The use of any appropriate medical treatment,

service, equipment and/or supply as provided by a

Hospital, skilled nursing facility , physician or other

provider which is necessary for the diagnosis, care

and/or treatment of a Health P lan MemberÔs Illness

or injury, and which is:

¤ Consistent with the symptom, diagnosis and

treatment of the Health Plan MemberÔs condition;

¤ The most appropriate level of supply and/or

service for the diagnosis and treatment of the

Health Plan MemberÔs c ondition;

¤ In accordance with standards of acceptable

medical practice;

¤ Not primarily intended for the personal comfort

or convenience of the Health Plan Member, the

Health Plan MemberÔs family, the physician or

other health care providers;

¤ Approv ed by the appropriate medical body or

health care specialty involved as effective,

appropriate and essential for the care and

treatment of the Health Plan MemberÔs condition;

and

¤ Not experimental or investigational .

16. The service must meet all of the above - referenced criteria in order to

be medically necessary. Given the above definition, if a service is

experimental or investigational, then it cannot be medically necessary.

17. Section V I . Limitations a nd Exclusions in the Plan Document

specifically exc lude services that are Ñexperimental/investigational or not

medically necessary treatment with the exception of routine care in

connection with a clinical trial in cancer, pursuant to the Florida Clinical

Trial Compact and the Patient Protection and Aff ordable Care Act.Ò

18. ÑExperimental and/or InvestigationalÒ is defined as follows:

For the purposes of this Plan a medication,

treatment, device, surgery or procedure may

initially be determined by AvMed to be

experimental and/or investigational if any of the

following applies:

¤ The FDA has not granted the approval for

general use; or

¤ There are insufficient outcomes data available

from controlled clinical trials published in peer -

reviewed literature to substantiate its effectiveness

for the disease or injury involved; or

¤ There is no consensus among practicing

physicians that the medication, treatment, therapy,

procedure or device is safe or effective for the

treatment in question or such medication,

treatment, therapy, procedure or device is not the

standard treatment, therapy procedure or device

utilized by practicing physicians in treating other

patients with the same or similar condition; or

¤ Such medication, treatment procedure, or device

is the subject of an ongoing Phase I or Phase II

clin ical investigation, or Experimental or research

arm of a Phase III clinical investigation, or under

study to determine: maximum tolerated dosage(s),

toxicity, safety, efficacy, or efficacy as comparted

with the standard for treatment or diagnosis of the

co ndition in question.

19. If any one or more of the above - cited criteria are met, then the

treatment is experimental and/or investigational and is not a covered service.

20. In making an adverse determination as to coverage in both the Level I

and Level II a ppeals, Edwin Rodriguez , M.D. (note the slightly different

spelling of PetitionerÔs expert Dr. Maria - Amelia Rodrigue s versus Dr. Edwin

Rodrigue z ), and Nurse Thomas - Brown utilized AvMedÔs Medical Coverage

Guideline on PBRT . This coverage guideline regardi ng PBRT provides

AvMedÔs ÑExclusion CriteriaÒ explaining ÑPBRT is not covered, and is

considered investigational, as to all other tumors not listedÒ in the guideline.

PBRT is not an approved treatment option for localized prostate cancer under

the NIA Mage llan criteria.

21. The Medical Technology Assessment Committee at AvMed drafts

clinical policy guidelines and is responsible for maintaining or changing them

as technology advances.

22. AvMedÔs policy on use of PBRT for the treatment of prostate cancer

sta tes that it is not medically necessary because studies have not shown

clinical outcomes to be superior to conventional radiation therapy

(i.e. , IMRT).

23. This policy was developed following extensive review of studies in

peer - reviewed medical literature, available guidelines, technology

assessments, and opinions from experts. The policy is updated on a yearly

basis in order to take into consideration any new evidence. A recent review of

the policy on PBRT resulted in no change in AvMedÔs position on covera ge for

treatment of prostate cancer.

24. The medical coverage guidelines are meant to be used in conjunction

with the Plan Document to determine whether services are medically

necessary and a covered benefit.

25. Dr. Gorty , AvMedÔs external reviewer fr om Magellan Healthcare , who

was accepted as an expert in the field of r adiation o ncology, testified that his

recommended denial of coverage of PBRT was informed by PetitionerÔs

medical records, IntervenorÔs Letter of Medical Necessity, clinical trials, the

model policy from the American Society of Therapeutic Radiation and

Oncology ( Ñ ASTRO Ò ), and the National Comprehensive Cancer Network

( Ñ NCCN Ò ) guidelines.

PBRT

26. PBRT is a procedure that uses protons to deliver a curative radiation

dose to a tumor, whil e reducing radiation doses to healthy tissues and organs,

which results in fewer complications and side effects than IMRT.

27. As stated earlier, PetitionerÔs prostate was removed in April 2018.

Thereafter, rising PSA levels indicated that he needed furthe r treatment , and

Dr. Rodrigues, a board - certified radiation oncologist at Miami Cancer

Institute , became his treating physician.

28. Dr. Rodrigues has been treating patients for 23 years, including

prostate cancer patients . She was accepted as an expert in her field for these

proceedings.

29. Dr. Rodrigues determined PBRT to be the appropriate radiation

treatment for Mr. Zolfaghari given his type of prostate cancer Ð recurrent

prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs

when a cancer has been treated and then reoccurs.

30. In addition to PBRT , Dr. R odrigues recommended , and Petitioner

received , androgen depr i vation therapy , generally referred to as hormone

therapy, to be used in conjunction with PBRT . Dr. Rodrigues testified that

the androgen depr i vation therapy blocks the production of testosterone. She

testified that patients with recurrent prostate cancer or certain high - risk

patients have better overall survival when the two treatments are used in

conjunction.

31. As an ad ditional aggravating factor to PetitionerÔs cancer treatment,

Petitioner was diagnosed with colon cancer leading to surgery in

January 2020. Dr. Rodrigue s testified that Petitioner Ôs colon cancer made his

need for PB RT even more necessary, because now Peti tioner is at a higher

risk for adverse effects from the unwanted spread of toxicity common with

IMRT .

32. Dr. Rodrigues, as a Miami Cancer Institute physician, wr ote letters

requesting treatment and appealing denials of treatment as set forth above ,

and te stified at the March 9, 2020 , administrative hearing in support of

Petitioner Ôs efforts to obtain coverage through AvMed for P BRT , which she

considers to be a medically necessary treatment modality .

33. Dr. Rodrigues was asked why she had not gone forward and provided

Petitioner IMRT in order to prevent any further delay due to the passage of

time from unsuccessful appeals of the denial by AvMed for the PBRT

treatment of his recurring prostate cancer. She replied that she was

attempting to secure a less tox ic treatment modality, PBRT, for her patient

who was already approved by Medicare for coverage of 80 percent of the cost

of the treatment.

M EDICAL N ECESSITY OF PBRT VERSUS IMRT

34. There is no dispute that IMRT is an accepted treatment modality for

Petit ionerÔs recurrent prostate cancer, even bearing in mind his complicating

factor of colon cancer surgery and treatment endured following his 2018

prostatectomy. The remaining dispute here is whether PBRT is both

medically necessary and not an experimental a nd/or investigative form of

radiation treatment.

35. IMRT is a recognized form of treatment for PetitionerÔs recurrent

prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute

considered only candidates for P BRT as those who would qualify for I MRT,

such as Petitioner. Given the availability of another treatment option, IMRT,

which is the most widely recognized s tandard of c are within the medical

establishment for the treatment of PetitionerÔs condition , RespondentÔs

experts conclude that PBRT is not medically necessary because it is not the

most appropriate level of service in this case.

36. While PBRT has been accepted by AvMed, according to its Plan, for

certain types of cancer, the insurer has not yet authorized it for the

treatment of prostat e cancer. This is where the semantics of the contract

come into play. Petitioner and Intervenor argued that Respondent

mistakenly based its denial upon a diagnosis of Ñlocalized prostate cancerÒ

(Dr. RodriguesÔ reading of the proscription of the use of PBR T for Petitioner)

rather than Ñrecurrent prostate cancerÒ (not specifically proscribed by the

Plan according to her reading), combined with the fact that PetitionerÔs

unique medical condition requires lower toxicity in the specific type of

radiation used. PBRT, she testified, offers lower radiation toxicity, which will

have less of a harmful effect on PetitionerÔs colon and rectum as a survivor of

colon cancer surgery.

37. Dr. Rodriguez, the AvMed senior m edical d irector, testified that

studies comparing P B RT to 3 - D confirming radiation or IMRT are limited.

Overall studies have not shown clinical outcomes to be superior to

conventional radiation therapy .

38. In addition to the p reservice and Level I a ppeal reviews by AvMed,

and RespondentÔs Level II a ppeal r eview, an Independent Organization

Review ( Ñ IRO Ò ) was conducted by a licensed r adiation o ncologist employed by

Independent Medical Expert Consulting Services . As a result of this

independent review, the PlanÔs denial was upheld.

39. Dr. Rodrigues presented studies in her testimony and a letter of

medical necessity which cited the potential for favorable outcomes with

P BRT . Dr. Gorty, RespondentÔs expert in radiation oncology, contradicted her

testimony in that many of the studies she cited note d a need for further study

regarding the safety and efficacy of PBRT for treatment , and all of these

studies were based upon Ñlocalized prostate cancer , Ò rather than Ñrecurrent

prostate cancer . Ò Dr. Gorty also testified that Petitioner's records indicated

that his canc er was localized, although it could also be "recurrent." Dr. Gorty

testified that clinical studies show no significant difference in the toxicity

between IMRT and PBRT. Further, Dr. Rodriguez explained that localized

cancer can be recurrent. ÑLocalizedÒ re fers to where the cancer may be found,

while ÑrecurrentÒ refers to a repeat or re - occurrence of a cancer, which might

return to the same location or reappear in a different location.

40. P aragraph 15 list s the criteria to determine whether a treatment or

p rocedure is Ñmedically necessaryÒ under the AvMed policy. PBRT does not

meet the third criteri on of the definition of Ñmedically necessary , Ò as PBRT

treatment of prostate cancer is not in accordance with standards of

acceptable community practice. Dr. Gort y testified that AvMed medical

guidelines utilize IMRT as the Ñnext generationÒ treatment, rather than

P BRT . Further, Dr. Gorty testified that he was aware of several recent

clinical trials concerning PBRT and IMRT, and these studies do not reach a

conclus ion that P BRT is preferable to IMRT.

41. PBRT does not meet the fifth criteri on of the definition of Ñmedically

necessary , Ò as PBRT has not been approved by the appropriate medical body

or healthcare specialty involved as effective, appropriate , and essent ial for

the care and treatment of prostate cancer. PBRT is not essential for the

treatment of prostate cancer. There are several treatment modalities that are

generally available for the treatment of prostate cancer and, as discussed

above, several of thos e treatment options were reasonable treatment options

for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for

Petitioner in this case due to, in her opinion, fewer adverse side effects of the

treatment, s he admitted that Petitioner is a suit able candidate for IMRT.

42. Therefore, PBRT does not meet the sixth criteri on of the definition of

Ñmedically necessary,Ò as it meets the definition of Ñexperimental and/or

investigational.Ò Specifically, criteria 2, 3, and 4 of the definition of

Ñexperim ental and/or investigationalÒ are met , which lead to the ultimate

conclusion that PBRT is not medically necessary in this case .

E XPERIMENTAL A ND / O R I NVESTIGATIONAL T REATMENT

43. Paragraph 18 sets forth the criteria for determining whether

a treatment or pr ocedure is Ñexperimental and/or investigational.Ò The second

criterion from the definition of experimental and/or investigational treatment

is met in this case. I nsufficient outcomes data are not available from

controlled clinical trials published in peer - reviewed literature to

substantiate PBRTÔs safety and effectiveness for treatment of prostate

cancer. Dr. Rodriguez testified that there is a lack of peer - reviewed ,

published , randomized studies regarding proton beam therapy .

44. Further, P BRT treatment is not the generally accepted standard of

care. Dr. Rodrigues testified that only a handful of medical centers in the

United States are using PBRT to treat cancer malignancies. Only two such

programs are located in Florida Ð the University of Florida and Inter venor.

Outside of Florida, only Massachusetts General and Loma Linda offer the

treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred

her patients to one of these other facilities for PBRT when she deemed it

appropriate to do so.

45 . Current randomized trials are on - going and being published in peer -

reviewed medical literature. PBRT treatment for prostate cancer is

considered investigational and not a standard of care option and , therefore,

not medically necessary. Nurse Thomas - Brown testified that a treatment

considered experimental or investigational is , automatically , not medically

necessary.

46. NIA Magellan Clinical Guideline Number NIA_CG_124 , which was

developed in July 2018 for implementation in January 2019 to assist

phys icians in the application of treatment , states that both surgery and

radiation therapy should be used to treat organ confined prostate cancer, as

well as prostate cancers extended into adjacent tissues. This guideline finds

that PBRT is not an approved tre atment option for localized prostate cancer

as studies comparing it to 3 - D conformal radiation or IMRT are limited.

47. Leading organizations , such as NCCN and ASTRO , have noted

insufficient data outcomes and a need for more study of proton beam therapy ,

which these organizations have not yet accepted as the standard of care .

48. PBRT also meets the third criterion of the definition of Ñexperimental

and/or investigational.Ò There is no consensus among practicing physicians

that PBRT is safe or effective fo r the treatment of prostate cancer or that

PBRT is the standard treatment utilized by practicing physicians in treating

other patients with the same or similar condition s . Both Dr. Gorty and

Dr. Rodriguez testified that proton beam therapy is experimental and

investigational and , therefore, not medically necessary for all forms of

prostate cancer; two additional r adiation o ncologists reviewed the appeal and

reach ed the conclusion that PBRT is not medically necessary.

49. Additionally, there was uncontrovert ed evidence that IMRT, not

PBRT, is the standard form of treatment utilized by practicing physicians for

treatment of prostate cancer.

50. Dr. Gorty testified that AvMed approved the NIA Magellan clinical

guidelines for prostate cancer , which are based on the peer - reviewed studies;

and he explained three such studies. His testimony noted that the second

study from the University of Pennsylvania at Baltimore, Maryland ,

specifically matched PetitionerÔs medical condition. This study compared

307 men and their comparative toxicity outcomes of P BRT verses IMRT for

post - operative sites. It concluded that future p rospective investigation and

on going follow - up will determine whether dosimetric difference s between

treatment with IMRT and proton beam therapy convert to meaningful

differences in long - term outcomes.

51. As part of the appeal process on behalf of Petitioner, Intervenor also

requested a review by an IRO . The review was completed by a board - certified

r adiation o ncologist , and a report was generated on Janu ary 9, 2020. The

ÑList of Materials ReviewedÒ is extensive and includes PetitionerÔs medical

records and IntervenorÔs supporting documentation. The independent

reviewer upheld the denial and noted that medical necessity has not been

established. The IRO st ates that Ñuntil the current randomized trials ongoing

are published in peer reviewed medical literature, proton beam treatment for

prostate cancer is considered investigational and not a standard of care

treatment option.Ò

C ONCLUSIONS OF L AW

52 . DOAH ha s jurisdiction over the parties to and the subject matter of

this proceeding. §§ 120.569 and 120.57, Fla. Stat.

53. Respondent is the state agency charged by the Legislature with

oversight of the administration of the state group insurance program.

§ 110. 123(3)(c), Fla. Stat.

54. The Plan is a health insurance benefit enacted by the Florida

Legislature and offered by Respondent. § 110.123, Fla. Stat.

55. In administrative proceedings, the party asserting the affirmative of

an issue is required to prove tha t he or she is entitled to the relief sought.

Young v. Dep't of Cmty. Aff. , 625 So. 2d 831, 833 - 34 (Fla. 1993); Dep't of

Transp. v. J.W.C. Co. , 396 So. 2d 778, 788 (Fla. 1st DCA 1981). The burden of

proof that applies is a preponderance of the evidence. § 120.57(1)(j), Fla. Stat.

In this proceeding, Petitioner bears the burden of proving by a preponderance

of the evidence that PBRT is a benefit covered under the Plan. If Petitioner

meets this requirement, then the burden shifts to Respondent to prove that

t he claims were not covered due to the application of a policy exclusion.

Herrera v. C.A. Seguros Catatumbo , 844 So. 2d 664 (Fla. 3d DCA 2003); State

Comprehensive Health Ass'n v. Carmichael , 706 So . 2d 319, 320 (Fla. 4th

DCA 1997).

56. In this case, one cr iteri on in the definition of Ñmedically necessaryÒ is

that the treatment at issue cannot be Ñexperimental and/or investigational.Ò

Therefore, in proving that the treatment was medically necessary, Petitioner

also had to prove that the treatment was not Ñex perimental and/or

investigationalÒ as defined in the Plan Document. A treatment that is

experimental and/or investigational is excluded by the Plan.

57. Petitioner and Intervenor failed to meet their burden of proving that

PBRT was medically necessary. The y failed to present competent substantial

evidence that each of the criteria in the definition of Ñmedically necessaryÒ

was met. The greater weight of the evidence presented was that criteria 2, 3,

4, and 5 were not met.

58. Additionally, a preponderance o f the evidence supports a finding that

PBRT for treatment of prostate cancer is experimental and/or investigational

as criteria 2, 3, and 4 of that definition are met. Petitioner and Intervenor

failed to present sufficient evidence to rebut RespondentÔs wi tness testimony

and documentary evidence on this issue. The independent reviewerÔs report ,

introduced by Petitioner, also confirms that PBRT for prostate cancer is

considered investigational and not a standard of care treatment option. Since

the treatment is excluded as an experimental and/or investigational service,

it also fails to meet the definition of medically necessary treatment.

59. The therapy fails to meet the definition of medically necessary and ,

while recent clinical trials on the efficacy of i ts use for prostate cancer are

underway, it currently continues to satisfy the criteria that render PBRT

experimental and / or investigational. None of these clinical trials have

acknowledged PBRT as preferable treatment for PetitionerÔs recurrent

prostate c ancer.

60 . Petitioner's frustration regarding this coverage decision is not

surprising , especially where, as here, the treatment proposed was approved

for Medicare coverage. Acceptance by one insurer, but not another, is,

understandably, difficult for him to accept when his physician, in good faith,

has convinced him of the necessity for PBRT versus IMRT. However, the

issue for determination here is not whether Medicare has elected to cover the

therapy, but whether PBRT is a medically necessary treatment as defined in

the Plan , which covers services offered to state workers and their dependents.

By virtue of the PlanÔs definition of medical necessity, which controls the

benefit determination for its insureds , proton beam therapy for the treatment

of localize d or recurrent prostate cancer is not a covered benefit at this time.

61. The conclusion reached by the undersigned in this case is not intended

to declare that prescribing or administering PBRT is below the standard of

care. A qualified physician's (such as Dr. Rodrigues) consideration of a

p articular therapy as best for her patient does not always mean that the

treatment will translate into a covered service. The definitions for a

medically necessary service are for the purpose of benefit decisions and no t

necessarily clinical treatment decisions.

62. In the Proposed Recommended Order submitted by Petitioner and

Intervenor, they declare that Ñ[b]asic contract principles of insurance law

apply hereÒ:

Florida law provides that insurance contracts are

constru ed in accordance with the plain language of

the policies as bargained for by the parties. See

[ Prudential Prop. & Cas. Ins. Co. v. ] Swindal ,

622 So. 2d at 470. If the relevant policy language is

susceptible to more than one reasonable

interpretation, one p roviding coverage and the

another limiting coverage, the insurance policy is

considered ambiguous. See Weldon v. All Am. Life

Ins. Co. , 605 So. 2d 911, 914 Ï 15 (Fla. 2d DCA

1992); see also Container Corp. of Am. v. Maryland

Cas. Co. , 707 So. 2d 733, 736 ( Fl a. 1998) (where

policy language is susceptible to differing

interpretations, it should be construed in favor of

the insured). Ambiguous policy provisions are

interpreted liberally in favor of the insured and

strictly against the drafter who prepared the po licy.

See CTC Dev. Corp. , 720 So. 2d at 1076; Swindal ,

622 So. 2d at 470. Likewise, ambiguous insurance

policy exclusions are construed against the drafter

and in favor of the insured. See Deni Assocs. of Fla.,

Inc. v. State Farm Fire & Cas. Ins. Co. , 711 So. 2d

1135, 1138 (Fla. 1998). In fact, exclusionary clauses

are construed even more strictly against the

insurer than coverage clauses. See State

Comprehensive Health Ass'n v. Carmichael , 706 So.

2d 319, 320 (Fla. 4th DCA 1997).

Auto - Owners Ins. Co. v. Anderson , 756 So. 2d 29, 34 (Fla. 2000).

63. This accurate statement of the principles for reading the plain

language of an insurance policy and construing any ambiguities in the

language of the policy in favor of the insured and against the insurer set fo rth

long - established principles of construction concerning insurance contracts.

These principles apply to the reading of the Plan language related to whether

PBRT is a covered expense for PetitionerÔs recurrent prostate cancer in this

case . AvMedÔs senior medical director, Dr. Rodriguez, an expert in internal

medicine, testified about the Plan language regarding the use of PBRT as

Ñnot approved for the treatment of localized prostate cancer.Ò He further

testified, and the undersigned credits his testimony ( also supported by

Dr. Gorty, RespondentÔs expert radiation oncologist) that the use of the term

ÑrecurrentÒ does not change his opinion, nor does it negate the findings of

Dr. RodriguesÔ s cited clinical trials in support of her advocacy on behalf of

Petiti oner. ÑRecurrence,Ò or a return, of cancer to an affected area is not the

antonym of Ñlocalized.Ò A recurrence of cancer can be localized or not, and the

inclusion of the term ÑlocalizedÒ in the Plan and NIA Magellan guidelines

does not transform Ñrecurren tÒ into a different type of prostate cancer that

should be read into the plain language of the coverage. The fact that the Plan

does not cover PBRT for Ñlocalized prostate cancer,Ò does not translate into

coverage fo r Ñrecurrent prostate cancer,Ò nor does it support, based upon the

clinical trials to date and the guidelines of accepted organizations, such as

NIA Magellan and NCCN, the use of PBRT rather than IMRT as the

preferred treatment for PetitionerÔs condition.

64. Recurrence of prostate cancer after a prostatectomy can still be treated

as localized, although, as testified to in this case, the locality of the cancer (it

could not have recurred in the prostate gland itself since that was removed in

2018) has recurred in the prostate bed, seminal vesicl es, and adjacent lymph

nodes, all areas in close proximity or ÑlocalizedÒ to the prostate. Each of these

areas is reachable by radiation therapy. Dr. RodriguesÔ s preference for

treating the recurrence with PBRT rather than IMRT is, in her opinion, to

achie ve a result with fewer adverse side effects. She did not testify that IMRT

would not attack the cancer and provide the patient with a favorable result.

Dr. RodriguesÔ s personal preference for PBRT here, based upon her dedicated

care and concern for the bes t outcomes for her patient and the fact that she

works in one of the few facilities in the country offering proton beam therapy,

does not override the only radiological treatment authorized by the Plan for

prostate cancer, IMRT. Her care for Petitioner and , presumably, for all her

patients is admirable, but without the clinical trials and nationally

recognized support for the treatment modality she has selected, PBRT cannot

be authorized for reimbursement in this case under th e Plan.

65. The only remaining concern here that was not fully addressed at

hearing is the delay in Petitioner receiving treatment of his cancer by IMRT,

due to the several levels of appeal of the denial of authorization for PBRT by

AvMed. The undersigned has no doubt in the sincerity o f Dr. Rodrigues in

seeking what she believes to be the best treatment for her patient. Hopefully,

the passage of time will have had no measurable bearing on the efficacy of

whatever radiation treatment is ultimately employed for Petitioner. One

thing is cl ear, there is no absolute right to the best treatment for a medical

condition according to your physicianÔs opinion. An insured is entitled to an

appropriate treatment modality that is designed to fully treat and, hopefully,

resolve the medical issue. The preponderance of the evidence supports IMRT

as an approved, tested, and efficacious treatment modality for PetitionerÔs

recurrent prostate cancer. He should continue his treatment as expeditiously

as possible.

R ECOMMENDATION

Based on the foregoing Findin gs of Fact and Conclusions of Law, it is

R ECOMMENDED that the Department of Management Services, Division of

State Group Insurance, enter a final order denying Petitioner's request for

coverage for proton beam therapy.

D ONE A ND E NTERED this 4th day of May , 2020 , in Tallahassee, Leon

County, Florida.

S

R OBERT S. C OHEN

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.sta te.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 4th day of May , 2020 .

C OPIES F URNISHED :

Erica D. Moore, Esquire

Thomas E. Wright, Esquire

Department of Management Services

4050 Esplanade Way , Suite 160

Tallahassee, Florida 32399

(eServed)

Abolghasem Zolfaghari

10910 Southwest 140th Avenue

Miami, Florida 33186

Frank A. Florio, Esquire

Maria D. Garcia, Esquire

Latasha Gethers Hines, Esquire

Kozyak, Tropin & Throckmorton, LLP

2525 Ponce de Leon Boulevard , Ninth Floor

Coral Gables, Florida 33134

(eServed)

William Chorba, General Counsel

Office of the General Counsel

Department of Management Services

4050 Esplanade Way, Suite 160

Tallahassee, Florida 32399 - 0950

(eServed)

N OTICE OF R IGHT T O S UBMIT E XCEPTIONS

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.