21-002236 Amy Baco-Taylor vs. Department Of Management Services, Division Of State Group Insurance Status: Closed Recommended Order on Wednesday, February 2, 2022.

Summary: Petitioner failed to prove intravenous immunoglobulin, an experimental and/or investigational treatment, was medically necessary.

S TATE OF F LORIDA

D IVISION OF A DMINISTRATIVE H EARINGS

A MY B ACO - T AYLOR ,

Petitioner ,

vs. Case No. 21 - 2236

D EPARTMENT OF M ANAGEMENT S ERVICES ,

D IVISION OF S TATE G ROUP I NSURANCE ,

Respondent .

/

R ECOMMENDED O RDER

Pursuant to notice, a formal administrative hearing was conducted before

Administrative Law Judge (ÑALJÒ) Yolonda Y. Green of the Division of

Administrative Hearings (ÑDOAHÒ) on October 25 and 27 , 202 1 , by Zoom

C onfer ence w i th the ALJ located in Tallahassee, Florida.

A PPEARANCES

For Petitioner: Amy Baco - Taylor , pro se

3137 Lisa Court

Tallahassee, F lorida 32312

For Respondent: Erica D. Moore, Esquire

Department of Management Services

Division of State Gr oup Insurance

4050 Esplanade Way , Suite 160

Tallahassee, Florida 32399

S TATEMENT OF T HE I SSUE

Whether PetitionerÔs request for coverage of intravenous immunoglobulin

( Gammagard Liquid ) (Ñ IVIGÒ) is a covered medication pursuant to the State

EmployeesÔ Plan (ÑPlanÒ), administered by Capital Health Plan (ÑCHPÒ)

through CVS Caremark (ÑC aremark Ò) .

P RELIMINARY S TATEMENT

Petitioner is a member of the Plan as a n employee of the State of Florida.

Petitioner was diagnosed with SjogrenÔs syndrome, a nt i - p hospholipid

syndrome, small fiber neuropathy , and Postural Orthostatic Tachycardia

Syndrome (ÑPOTSÒ) . Her provider submitted a request for IVIG for treatment

of her condition. On June 3, 2021, Respondent issued a Level II Appeal

Determination letter, de nying coverage for IVIG because Ñ your medical

records indicate your condition does not meet the medically necessary

coverage criteria for IVIG under your plan. Additionally, your provider off -

label use request is considered experimental/investigational whi ch is a

specific plan exclusion. Ò On July 1, 2021 , Petitioner appealed and filed a

petition for administrative hearing.

On October 25, 2021 , the final hearing was held. Petitioner testified on

h er own behalf and presented the testimony of Victor McMillan, M.D.,

PetitionerÔs treating physician for autoimmu n e disorders; Gadi

Silberman, M.D., PetitionerÔs treating physician for dysautonomia and POTS;

Christopher Taylor, PetitionerÔs husband ; and E. Brendan Roark , Ph.D.,

PetitionerÔs colleague. Respondent pres ented the testimony of Edward ÑPaulÒ

Amundson , M.D., offered as an expert in claims management and family

medicine; and Dearline Thomas - Brown, MPH, BSN, RN, legal nurse

coordinator for Respondent. PetitionerÔs Exhibits 1 through 1 7 were admitted

into evide nce. RespondentÔs Exhibits 1 through 1 4 were admitted into

evidence.

RespondentÔs Motion for Confidential Court Filing of Proposed

Recommended Order , filed post - hearing on December 9, 2021, is granted. As

a result of the undersignedÔs ruling, b oth Petiti onerÔs and RespondentÔs

Proposed Recommended Order s ( Ñ PROÒ) shall remain confidential.

The three - volume Transcript of the final hearing was filed with DOAH on

November 30, 2021. The parties timely filed their PROs and both submittals

have been considered i n preparation of this Recommended Order.

All references to the Florida Statutes are to the 20 20 version, unless

otherwise specified.

F INDINGS OF F ACT

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

employee health insurance progra m pursuant to section 110.123 , Florida

Statutes.

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

is a third - party administrator for the Plan at issue in this ca se . As the third -

party administrator, CHP 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. The P lan Document

includes a Prescriptio n Drug Plan (ÑPDPÒ) , which states certain medications

are available only through Caremark. Caremark is the Pharmacy Benefit

Manager ( Ñ PBM Ò ) for the PDP at issue in this cause.

3 . As the PBM, CVS provides claims processing, utilization, and benefit

manageme nt services for prescription drugs. Injectable drugs , such as IVIG,

are also subject to CVSÔ s Specialty Guideline Management policy, Reference

# 2041 - A.

4. Petitioner is a 47 - year - old woman who was diagnosed w ith SjogrenÔs

syndrome, a nti - p hospholipid syndr ome, small fiber neuropathy , and POTS.

The Petitioner testified that her medical condition ha s significantly reduce d

her quality of life, her ability to c omplete activities of daily living, her

interactions with her children, and the quality of life and he alth of her

spouse . Petitioner also explained the effects the medical conditions have had

on her career as an oceanographer. Specifically, s he has been unable to

participate in field research at sea , to travel, or to stand for reasonable

periods of time.

5 . Petitioner, through her treating rheumatolog ist , Dr. McMillan,

submitted a request for coverage of IVIG to C aremark.

6 . Authorization for a specialty drug can be obtained based on the

application of currently acceptable medical guidelines. IVIG is one of the

specialty drugs for which satisfaction of the medical review criteria is

required.

7 . Thus, IVIG is only available through Caremark, as a specialty drug,

subject to review and approval under CaremarkÔs Specialty Guideline

Management Program.

8 . On February 9, 2021, CVS denied the pre - service request for coverage

on the basis that coverage for the drug is not allowed unless the patient had

one of the listed conditions. Coverage for small fiber neuropathy was not

listed as a basis for coverage.

9 . On March 8, 2021, Petitioner submitted a request for a Level I appeal

to CVS . The appeal was reviewed by Dr. Stephen Selkirk, M.D. , a consultant

specializing in neu rology , wh o is under contract with CVS for review of

requests . He filed a report dated March 9, 2021 .

10 . On March 10, 2021, CVS denied the request for Level I appeal on the

basis that due to a lack of high - quality clinical trials, the standard of care

guidelines do not support the use of IVIG for small fiber neuropathy.

T herefore , the appeal was de nied because it was deemed

experimental/investigational and , as a result, not medically necessary for the

treatment of PetitionerÔs conditions .

11 . On May 3, 2021 , Petitioner submit ted a request for a Level II appeal

to Respondent. The Level II appeal was reviewed by Dearline Thomas - Brown,

a registered nurse and Level II appeal coordinator for Respondent.

12 . On June 3, 2021 , Respondent denied PetitionerÔs Level II appeal on

the basis that the t reatment is not medically necessary for treatment of the

membe rÔs condition and is experimental/investigational .

13 . Prior to Petitioner filing the Petition for Formal Hearing, her request

was submitted for an external review which was review ed by an I ndependent

R eview O fficer (ÑIROÒ) . The review was completed by a b oar d - certified

internal medicine doctor with certification in rheumatology, and a r eport was

generated on September 8, 2021. The ÑList of Records ReviewedÒ include d

PetitionerÔs medical records, including laboratory results and clinical notes,

denial lette r, patient appeal letter, and policy criteria guidelines. The IRO

upheld the denial and noted that medical necessity has not been established.

The IRO state d that Ñ [IVIG] has not been approved by the appropriate

medical body or board for the illness of sma ll fiber neuropathy associated

with SjogrenÔs syndrome. Therefore , the requested health service is not

medically necessary È .Ò

14. T he Plan Document, Section I , entitled Introduction pertaining to

medical claims, provides in relevant part:

The Plan is no t intended to and does not cover or

provide any Medical Services or benefits that are

not Medically Necessary for the diagnosis and

treatment of the Health Plan Member. Capital

Health Plan determines whether the services are

Medically Necessary on the basi s of terms,

conditions, and criteria established by the Plan as

interpreted by the state, and as set forth in medical

guidelines.

15. T o be a cover ed drug, the drug must be Ñmedically necessary,Ò not

Ñexperimental or investigational,Ò and it must not be specifically excluded by

the Plan. The Plan provides that:

Pursuant to the Plan , ÑMedically NecessaryÒ is

defined as follows:

The use of any appropriate medical treatment,

service, equipment and/or supply as provided by a

Hospital, skilled nursing facili ty, physician or other

provider which is necessary for the diagnosis, care

and/or treatment of a Health Plan MemberÔs Illness

or injury, and which is:

¤ Consistent with the symptom, diagnosis and

treatment of the Health Plan MemberÔs condition;

¤ The m ost appropriate level of supply and/or

service for the diagnosis and treatment of the

Health Plan MemberÔs condition;

¤ 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;

¤ Approved by the appropriate medical body or

health care specialty involved as effective,

appropriate and essential for the care and

treatment of the Hea lth Plan MemberÔs condition;

and

¤ Not experimental or investigational.

16 . The medica l treatment m ust meet all of the appropriate criteria to be

considered Ñmedically necessary . Ò Given the above definition, if a service is

experimental or investigation al, then it cannot be medically necessary.

17 . Section VI , Limitations and Exclusions of the Plan Document ,

specifically exclude s services that are Ñexperimental/investigational or not

medically necessary treatment . Ò

18 . Pursuant to the Plan ÑExperimental and/or InvestigationalÒ is defined

as follows :

For the purposes of the Plan a medication,

treatment, device, surgery or procedure may

i nitially be determined by CHP 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 c onsensus 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 procedur e 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

clinical 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

condition in question.

19 . If any one o r m ore of the criteria set forth in the definition are met,

then the treatment is Ñ experimental and/or investigatio nal Ò and is not

covered under the Plan.

20 . To reach their respective determination for denial of PetitionerÔs

request for coverage for IVIG , all reviewers for the levels of appeal utilized

CVSÔ s guidelines for use of IVIG for treatment. Th ese specialty coverage

guidelines provide CHPÔ s Ñexclusion criteriaÒ which indicated IVIG is not

covered and is considered experimental and investigational and not medically

necessary .

21 . The specialty coverage guidelines are intended to be used in

co njunction with the Plan to determine whether medication is medically

necessary and a covered benefit. IVIG may be used to treat collagen vascular

disease , wh ich includes Sjogren Ô s syndrome.

22 . Dr. McMillan wrote a letter on PetitionerÔs behalf requesting use of the

medication and appealing denial of the medication. Dr. McMillan also

testified at the hearing in support of PetitionerÔs efforts to obtain coverag e

through CHP for IVIG.

23 . Dr. McMillan is board - certified in internal medicine with a

subspecialty in rheumatology. He has also written several publications

regarding Sjo g ren Ôs syndrome. Dr. McMillanÔs testimony is accepted as

PetitionerÔs treating phys ician and expert in the area of internal medicine

and rheumatology.

24 . Dr. McMillan determined IVIG was appropriate for treatment of

PetitionerÔs condition and noted that it has been shown to be effective for

severe or treatment - refractory in small publ ished reports. He pointed to

literature (Farhard) that focused on a small , uncontrolled study which

resulted in successful treatment with trial of IVIG in patients with Sjogren Ô s

syndrome. Of note, is that the study itself acknowledged that it was a small

study , and there were few studies on the use of IVIG for Sjogren Ô s syndrome.

25 . PetitionerÔs physician , Gadi Silberman, M.D., also sought to treat h er

condition with IVIG. Dr. Silberman testified that the treatments that have

been tried so far for Petitio ner are not adequate to treat her conditions .

Dr. Silberman also testified that a patientÔs quality of life and ability to

perform activities of daily living are important considerations in determining

whether a medication is Ñmedically necessary . Ò

26. Dr . Amundson , a board - cert ified physician in Family Medicine with

training in internal medicine , testified as RespondentÔs expert. He has no

training in neuropsychology or cardiology. In addition, unlike Dr. McMillan,

he does not have a specialty in rheumato logy. T he parties stipulated to

Dr. A dmundson as an expert. However, h is testimony , when weighed against

the testimony of Dr. McMillan , a current practicing specialist in the field of

rheumatology , is given less er weight.

27. As noted herein, the criteria to determine whether a treatment or

procedure is Ñmedically necessaryÒ under the Plan includes six criteria.

Dr. Amundson testified, in relying upon the report from the I RO , that IVIG

does not meet criteria five and six.

28 . IVIG does not meet the fifth cr iteri on of the definition of Ñmedically

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

or healthcare specialty involved as effective, appropriate, and essential for

the care and treatment of small fiber neuropathy . IVIG is not es sential for

the treatment of PetitionerÔs condition .

29 . In addition, use of IVIG does not meet the sixth criterion of the

definition of Ñmedically necessary,Ò as it meets the definition of Ñexperimental

and/or investigational.Ò

30. If any of the criter ia of the definition of Ñexperimental and/or

investigationalÒ are met, then IVIG would be considered Ñexperimental

and/or investigational.Ò As set forth in paragraph 18 herein, the re are five

criteria for determining whether a treatment or procedure is Ñex perimental

and/or investigational.Ò

31 . Here , criteri on two of the definition of Ñexperimental and/or

investigationalÒ is met, which lead s to the ultimate conclusion that IVIG is

not medically necessary in this case. S ufficient outcome data are not

avail able from controlled clinical trials published in peer - reviewed literature

to substantiate IVIG Ôs safety and effectiveness for treat ment of small fiber

neuropathy. Current ly randomized trials have be en published in peer -

reviewed medical literature. However , there are only small controlled studies

pertaining to IVIG medication treatment for small fiber neuropathy.

Dr. Amundson testified that there is a lack of peer - reviewed, published,

randomized studies regarding IVIG . Thus, the treatment meets criterion tw o.

Nurse Thomas - Brown testified that a treatment considered experimental or

investigational is, automatically, not medically necessary.

32 . Both parties relied upon information from medical journals and

publications in support of their respective p osition s . In addition, Respondent

relied upon the I RO report and its statements. The individual who prepared

the report did not testify at the hearing. Thus , the report and any statements

therein are considered hearsay. Generally, hearsay statements, without

corro boration by a person with knowledge of the area at issue, could not be

relied upon to make findings of fact.

33. Here, Dr. Amundson did not prepare the IRO report . However, he

testified about the findings based on his knowledge of the subject matter.

34. Overall, Petitioner established that use of IVIG was medically

necessary from a clinical standpoint. The use of IVIG for small fiber

neuropathy associated with SjogrenÔs syndrome is not approved by the

Federal Drug Administration (FDA). The use of a drug for a purpose other

than the uses approved by the FDA is referred to as an Ñoff - labelÒ use. The

off - label use of IVIG for SjogrenÔs syndrome as being effective from a medical

standpoint under the Plan has not been demonstrated in this case .

35. There was conflict in the evidence as to whether use of IVIG for

PetitionerÔs condition is medically necessary from a clinical standpoint or

medically necessary under the Plan. The undersigned finds as follows

regarding that conflict. Based on the applicable criteri a under the Plan, the

evidence presented at hearing , including medical records produced by

Petitioner and supporting literature, fails to demonstrate that Petitioner had

a medical condition that warranted coverage of treatment with IVIG.

36. Petitioner d id not establish at this time that IVIG is medically

necessary , as defined by the Plan , and did not establish that IVIG is not

experimental and/or investigational.

37. There was some testimony offered at the final hearing that use of IVIG

may be used for S jogrenÔs as a collagen vascular disease. However, there was

no evidence in the record to support collagen vascular disease being the

stated diagnosis for treatment with IVIG.

C ONCLUSIONS OF L AW

3 8 . DOAH has jurisdiction over the parties to and the subject matter of

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

3 9 . Respondent is the state agency charged by the Legislature with

oversight of the administration of the s tate group insurance program.

§ 110.123(3)(c), Fla. Stat

40 . The Plan is a health ins urance benefit enacted by the Florida

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

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

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

You ng v. Dep Ô t of Cmty. Aff. , 625 So. 2d 831, 833 - 34 (Fla. 1993); Dep Ô 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, Peti tioner bears the burden of proving by a prepond erance

of the evidence that IVIG is a prescription benefit covered under the Plan. If

Petitioner meets this requirement, then the burden shifts to Respondent to

prove that the claims were not covered due to th e application of a policy

exclusion. Herrera v. C.A. Seguros Catatumbo , 844 So. 2d 664 (Fla. 3d DCA

2003); State Comp . Health Ass Ô n v. Carmichael , 706 So. 2d 319, 320 (Fla. 4th

DCA 1997).

42 . In this case, one criterion in the definition of Ñmedically nece ssaryÒ 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 Ñexperimental and/or

investigational , Ò as defin ed in the Plan . A ny treatment , including medication

that is experimental and/or investigational is excluded by the Plan .

4 3 . Petitioner failed to meet her burden of proving that IVIG was

medically necessary. Petitioner failed to present competent substant ial

evidence that each of the criteria in the definit ion of Ñmedically necessaryÒ

was met. The greater weight of the evidence pr esented was that criteria five

and six were not met.

4 4 . Additionally, a preponderance of the evide nce supports a finding that

I VIG for treatment of PetitionerÔs condition is Ñ experimental and/or

investi gational Ò as criteri on two of that definition w as met. Petitioner failed

to present sufficient evidence to rebut RespondentÔs witness testimony and

documentary evidence on this issu e. The IROÔs report , introduced by

Respondent as substantiated by Dr. Admundson , also confirms that IVIG for

PetitionerÔs condition is considered investigational and not a standard of care

treatment option. Since the treatment is excluded as an Ñ experiment al and/or

investigational Ò service, it also fails to meet the definition of medically

necessary treatment.

4 5 . T here was a dispute regarding the definition of Ñmedically necessaryÒ

in this matter. Although Petitioner points out that use of IVIG for small f iber

neuropathy is Ñ medically necessary Ò from a clinical treatment standpoint,

again, the issue for determinat ion here is not whether the medication

treatment is Ñ medically necessary, Ò from a clinical standpoint, but whether

IVIG is Ñ medically necessary Ò t reatment as defined under the Plan. By virtue

of the PlanÔs definition of medical necessity, which controls the benefit

determination for i ts insureds, IVIG for the treatment of small fiber

neuropathy is not a covered benefit at this time.

4 6 . B ased on the evidence presented at hearing, Petitioner did not

establish the criteria for approval of IVIG for PetitionerÔs condition at this

time. Because t he treatment is excluded as not Ñ medically necessary Ò and it is

currently deemed Ñ experimental and/or investiga tional , Ò Petitioner Ô s coverage

must be denied.

R ECOMMENDATION

Based on the foregoing Findings 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 Peti tioner's request for

coverage for intravenous immunoglobulin (Gammagard Liquid).

D ONE A ND ENT ERED this 2nd day o f February , 2022 , in Tallahassee, Leon

County, Florida.

S

Y OLONDA Y. G REEN

Administrative Law Judge

1230 Apalachee Parkway

Tallahassee, Flo rida 32399 - 3060

(850) 488 - 9675

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 2nd day of February , 2022 .

C OPIES F URNISHED :

Erica D. Moore, Esquire Kristen Larson, Interim General Counsel

Department of Management Services Office of the General Counsel

Division of State Group Insu rance Department of Management Services

Suite 160 4050 Esplanade Way, S uite 16 0

4050 Esplanade Way Tallahassee, Florida 32399 - 0950

Tallahassee, Florida 32399

Amy Baco - Taylor

3137 Lisa Court

Tallahassee, Florida 32312

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 age ncy that will issue the Final Order in this

case.