STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
ANNA LEIGH MILLER, A MINOR, BY ) AND THROUGH HER PARENTS AND )
NATURAL GUARDIANS, LEIGH ) LASSITER MILLER AND THOMAS B. ) MILLER, AND LEIGH LASSITER ) MILLER AND THOMAS B. MILLER, ) INDIVIDUALLY, )
)
Petitioners, )
)
vs. ) Case No. 05-1851
)
DEPARTMENT OF MANAGEMENT )
SERVICES, DIVISION OF STATE )
GROUP INSURANCE, )
)
Respondent. )
________ )
RECOMMENDED ORDER
Pursuant to notice, a hearing was conducted in this case pursuant to Section 120.569, Florida Statutes,1 and Section 120.57(1), Florida Statutes, on September 2, 2005, by video teleconference at sites in Miami and Tallahassee, Florida, before Stuart M. Lerner, a duly-designated Administrative Law Judge of the Division of Administrative Hearings (DOAH).
APPEARANCES
For Petitioners: Clark W. Smith, Esquire
Paxton & Smith, P.A., Barristers Building, Suite 500 1615 Forum Place
West Palm Beach, Florida 33401
For Respondent: Sonja P. Mathews, Esquire
Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160
Tallahassee, Florida 32399-0950 STATEMENT OF THE ISSUE
Whether the Dynamic Orthotic Cranioplasty band prescribed to treat Petitioner Anna Leigh Miller's deformational plagiocephaly in 2004 was a covered benefit under the 2004 State Employees' PPO Plan.
PRELIMINARY STATEMENT
By letter dated December 20, 2004, Respondent advised Petitioners' attorney that it concurred with "Blue Cross and Blue Shield of Florida's (BCBSF's) determination that the charges for the Dynamic Orthotic Cranioplasty (DOC) Procedure, [that had been] prescribed for [Petitioner] Anna Leigh Miller, on June 23, 2004, and billed in the amount of $3,000, was not eligible for coverage under the Millers' State PPO Plan contract," explaining as follows:
Beginning on page 27 of the Benefit Document listed are the services and treatments that are not covered by the State Plan. Cosmetic treatment is one of the services not covered the State Plan. The Benefit Document defines cosmetic treatment in terms of five listed factors. The presence of any one of the five listed factors indicates that the treatment is cosmetic. In this case, three of the five factors are present in that DOC therapy was not:
administered to correct a congenital anomaly;
a procedure medically necessary to correct an abnormal bodily function;
administered for reconstruction to an area of the body that has been altered by the treatment of a disease.
The Division of State Group Insurance (DGSI) has also determined that the DOC therapy is not covered in that it is not medically necessary (see item 4 of the list), as that term is defined on page 53 of the Benefit Document. The absence of any one of the listed elements renders the treatment medically unnecessary. In this case, none of the element[s] that would make the treatment medically necessary is present.
Any service or procedure considered by BCBSF to be experimental or investigational, or services not in accordance with generally accepted professional standards, including complications resulting from these non- covered services are not covered. This exclusion is referenced in the State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document, page 31 and is defined on page 51. The presence of any of the factors renders a treatment experimental or investigational. In the present case, DSGI has determined that DOC band therapy is experimental and investigational in that DOC therapy to treat positional plagiocephaly:
is the subject of ongoing Phase I or II clinical investigations, or the experimental or research phase of a 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 condition;
is generally regarded by experts as requiring more study to determine maximum dosage, dosage, toxicity, safety or
efficacy, or to determine the efficacy compared to standard treatment for the condition; or
has not been proved safe and effective for treatment 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; or
is not accepted in consensus by practicing doctors as safe and effective for the condition; or
is not regularly used by practicing doctors to treat patients with the same of similar condition.
Petitioners, on December 30, 2004, filed a Petition Requesting Formal Hearing. In their Petition, Petitioners, in addition to requesting a "formal hearing" conducted by a DOAH administrative law judge, asked for the following relief:
That the Department's decision of December 20, 2004 be reversed;
That the State Employees PPO Plan administered by Blue Cross and Blue Shield of Florida, Inc. Contract Number XJJ 292091294, Group Number 76402, be ordered to pay and reimburse Thomas B. Miller and Leigh Lassiter Miller for the costs of the DOC Band pursuant to the benefit documents (the DOC Band cost $3,000.00 under the benefit booklet, the plan is obligated to pay for 60% of that, i.e., $1,800.00);
That the Plan be ordered to pay interest on the $1,800.00 from July 22, 2004 until the date of actual payment at the legal rate;
That the Department reimburse Thomas B. Miller and Leigh Lassiter Miller for
attorney fees and costs in pursuing this appeal . . . .
On May 20, 2005, the matter was referred to DOAH for the assignment of a DOAH administrative law judge to conduct the hearing Petitioners had requested.
On August 23, 2005, the parties filed a Pre-hearing Stipulation, which read, in part, as follows:
Nature of Controversy.
Section 110.123, Florida Statutes, established the State of Florida's self- insured health plan (State Plan), which is managed by the Division of State Group Insurance (DSGI), an administrative entity within the Department of Management Services (DMS). The terms and conditions of participation in the State of Florida's self-insured health program are contained in the "State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit
Document," effective January 2004 ("benefits document").
The Petitioners have appealed the denial of payment of benefits. The Petitioners maintain that the State Plan provides coverage for the dynamic orthotic cranioplasty (DOC) band that was prescribed to treat Anna Leigh Miller's positional plagiocephaly. The Respondent maintains that the DOC band was not covered under the Plan in that the prescribed treatment was "cosmetic," not "medically necessary," and because the DOC band is "experimental or investigational," as those terms are defined in the benefit document.
General Statement of Each Party's Position.
Position of Petitioners.
The Petitioners maintain that the prescription of the DOC band to treat positional plagiocephaly is medically necessary. Positional plagiocephaly is secondary to torticollis - a weakening of the neck muscles. The Respondent provided benefits for the neurosurgeon, Dr. Drew Schnitt, who prescribed the DOC band, as well as provided benefits for physical therapy to treat the torticollis.
Position of Respondent.
The Respondent maintains that the prescription of the DOC band to treat positional plagiocephaly is not covered by the State Plan in that the prescription of the DOC was "cosmetic," was not "medically necessary," and was "experimental or investigational," as those terms are defined in the benefit document. The terms and conditions of and benefits offered by other plans and insurance policies are not relevant.
* * *
Concise statement of those facts which are admitted and will require no proof at hearing, and, where applicable, reservation directed to the admissions.
Anna Leigh Miller is a minor, born on January 3, 2004.
Anna Leigh Miller is represented in this action by her parents and natural guardians, Leigh Lassiter Miller and Thomas B. Miller. They are represented by Paxton & Smith, P.A.
At all times relevant hereto, Anna Leigh Miller was covered by the State of Florida self-insured plan.
The terms and conditions of participation in the State of Florida's self-insured health program are contained in the "State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit
Document," effective January 2004 ("benefits document").
The DOC band for Anna Leigh Miller was prescribed by a qualified physician to treat positional plagiocephaly.
Anna Leigh Miller developed plagiocephaly after her birth.
The DOC band has been approved by the Federal Food and Drug Administration for the treatment of positional plagiocephaly.
Positional plagiocephaly is not a congenital condition.
Torticollis is weakening of the neck muscles.
Anna Leigh Miller exhibited symptoms of torticollis.
The DOC band cost $3,000.00 including all visits, fitting, adjustment and consultation.
Issues of law on which there is agreement.
There are no issues of law on which the parties agree.
Issues of fact which remain to be litigated.
Whether for the treatment of positional plagiocephaly, the DOC band has been proven
safe and effective, 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.
Whether Anna Leigh Miller developed as a result of torticollis.
Issues of law which remain for determination by the Administrative [L]aw [J]udge.
2.[sic] Whether the use of the DOC band to treat positional plagiocephaly is "cosmetic," as the term is defined in the "State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document," effective January 2004.
Whether the use of the DOC band to treat positional plagiocephaly is "medically necessary," as the term is defined in the "State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document," effective January 2004.
Whether the use of the DOC band to treat positional plagiocephaly is "investigative or experimental," as the terms are defined in the "State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document," effective January 2004.
Whether there is sufficient competent scientific evidence, as prescribed in the benefit document, including controlled randomized studies, upon which to make legal findings regarding the health outcome effects of positional plagiocephaly.
Whether there is sufficient competent scientific evidence, as prescribed in the benefit document, to determine the manner in which, if any, positional plagiocephaly affects a child developmentally.
Whether Petitioners are entitled to attorney's fees, and if so, the amount
* * *
On September 1, 2005, Petitioners filed a Hearing Brief, in which they argued that the "DOC band is not experimental"; that its use in the instant case was "not cosmetic, but on the contrary [wa]s medically necessary"; and that, upon prevailing in this case, they will be entitled to an award of attorney's fees pursuant to Section 627.6698, Florida Statutes.
As noted above, the hearing in this case was held on September 2, 2005.2 Four witnesses testified at the hearing: Walter Hollinger, M.D.; Melodie Bartel; Petitioner Leigh Lassiter Miller; and Petitioner Thomas Miller. In addition, the following exhibits were offered and received into evidence: Petitioners' Exhibits, 1a., 1b., 1c., 2a., 2b., 2d., 5, 6, 9 (the transcript and videotape of the deposition of Drew Schnitt, M.D., with attachments), and 10, and Respondent's Exhibits 1, 3 through 6, 8a., 8b., 16, 17, 22 through 32, 34 through 37, and
39 (the transcript of the deposition of Mutaz Habal, M.D., with attachments).
In a post-hearing order issued September 8, 2005, the undersigned advised the parties that their proposed recommended orders had to be filed no later than October 7, 2005. This filling deadline was twice extended at the joint request of the
parties. The second extension established an October 24, 2005, filing deadline.
Petitioners and Respondent timely filed their Proposed Recommended Orders on October 24, 2005.
FINDINGS OF FACT
Based on the evidence adduced at hearing, and the record as a whole, the following findings of fact are made to supplement and clarify the factual stipulations set forth in the parties' August 23, 2005, Pre-Hearing Stipulation3:
At all times material to the instant case, Petitioner Leigh Lassiter Miller has been employed by the State Attorney's Office in Palm Beach County.
As a benefit of her employment, she has received group health insurance under the State Employees' PPO Plan (Plan).
Respondent administers the Plan.
It does so with the assistance of Blue Cross and Blue Shield of Florida, Inc. (BCBSF).
BCBSF was hired by Respondent to provide medical claim processing services under the Plan.
The terms and conditions of the Plan that were in effect during the time period at issue in the instant case are set forth in the 2004 Plan Booklet and Benefits Document (Plan Document).
According to the Plan Document's "Introduction," the "PPO plan is designed to cover most major medical expenses for a covered illness or injury, including hospital and physician services."
The Plan Document's "Summary of Plan Benefits, Covered Services" advises that the Plan "pays a percentage of the cost of covered care and medical supplies as long as the care or supplies are ordered by a covered provider and are considered medically necessary as a result of a covered accident, illness, condition or mental or nervous disorder." For covered "durable medical equipment" obtained from a "non-network" provider, the percentage paid by the Plan is 60 percent.
The "Limitations and Exclusions" portion of the Plan Document contains a listing of "Services Not Covered By The Plan." This listing reads, in pertinent part, as follows:
The following services and supplies are excluded from coverage under this health insurance plan unless a specific exception is noted. Exceptions may be subject to certain coverage limitations.
Cosmetic surgery or treatment, unless it is:
a result of a covered accident and the surgery or treatment is performed while the person is covered by this health insurance plan
for correction of a congenital anomaly for an eligible dependent and performed
while the dependent is covered by this health insurance plan
a medically necessary procedure to correct an abnormal bodily function
for reconstruction to an area of the body that has been altered by the treatment of a disease
* * *
4. Any services or supplies which are not medically necessary, as determined by BCBSF clinical staff and DSGI.
* * *
17. Any services provided for preventative care - except those services provided as part of the well-child health supervision services or those services obtained through the $100 Health Screening benefit (see page 22).
* * *
45. Services and procedures considered by BCBSF to be experimental or investigational, or services and procedures not in accordance with generally accepted professional medical standards, including complications resulting from these non-covered services.
The Plan Document contains the following description of the process involved in "Appealing A Denied Claim":
If your benefit claim is totally or partially denied, BCBSF or Caremark, Inc. will send you a written notice on an Explanation of Benefits (EOB) statement stating the specific reason(s) for the denial within 30 days of receiving your claim. The notice will include a list of any additional information needed to appeal the denial to BCBSF or Caremark, Inc.
Appealing To The Third Party Administrator- A Level I Appeal
Within 90 days of the date of the EOB denial notice you or your authorized representative can appeal a claim that is denied. Your appeal must be in writing and should include any information, questions or comments you think are appropriate. Mail your written appeal to the third party administrator- BCBSF for medical claims or Caremark, Inc. for prescription drug claims - at the address shown on the inside cover of this booklet. The third party administrator will review your claim and provide you with a written notice of the review decision. On the notice, you will also receive information about appealing the decision to DSGI.
Appealing To DSGI - A Level II Appeal If you are not satisfied with the first
appeal decision given by the third party administrator, you may make a second appeal through DSGI. After you have asked the third party administrator to review your claim and you have received their written notification, you may submit a second appeal to DSGI. Your Level II Appeal must be in writing and must be received by DSGI not later than 60 days after the date of the written notice of the third party administrator decision regarding your Level I Appeal and must include:
a copy of the EOB
a copy of your letter requesting the third party administrator to review the claim
a copy of the third party administrator's written notice of their review decision
a letter to DSGI appealing the decision, and
any other information or documentation you think is appropriate.
Mail your written DSGI at the address shown on page 1. Send your appeal to the attention of the "Appeals Coordinator."
Requesting An Administrative Hearing
If you want to contest the second appeal decision, you must submit a petition for an administrative proceeding that complies with section 28-106.301, Florida Administrative Code. DSGI must receive your petition within 21 days after you received the written decision on your second appeal.
"Definitions Of Selected Terms Used By The Plan" are found on pages 49 through 55 of the Plan Document. These definitions include the following:
Accident [means] an accidental bodily injury that is not related to any illness.
* * *
Condition [means] any disease, illness, injury, accident, bodily dysfunction, pregnancy, drug addiction, alcoholism or mental or nervous disorder.
* * * Covered services and supplies [mean]
healthcare services and supplies, including pharmaceuticals and chemical compounds, for which reimbursement is covered under this health insurance plan. The Division of State Group Health Insurance has final
authority to determine if a service or supply is covered by the plan.
* * * Experimental or investigational
services [mean] any evaluation, treatment,
therapy or device that meets any one of the following criteria:
cannot be lawfully 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 is provided to the covered person [hereinafter referred to "Experimental/Investigational Criterion No. 1"]; or
is the subject of ongoing Phase I or II clinical investigation, or the experimental or research arm of a 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 condition [hereinafter referred to as "Experimental/Investigational Criterion No. 2"]; or
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 [hereinafter referred to as "Experimental/Investigational Criterion No. 3]; or
has not been proven safe and effective for treatment of the condition based on the most recently published medical literature of the U.S., Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices [hereinafter referred to as "Experimental/Investigational Criterion No. 4"]; or
is not accepted in consensus by practicing doctors as safe and effective for the condition [hereinafter referred to as "Experimental/Investigational Criterion No. 5"]; or
is not regularly used by practicing doctors to treat patients with the same or a similar condition [hereinafter referred to as "Experimental/Investigational Criterion No. 6].
BCBSF and DSGI determine whether a service or supply is experimental or investigational.
* * *
Illness [means] physical sickness or disease, pregnancy, bodily injury or congenital anomaly. For this plan, illness includes any medically necessary services related to non-emergency surgical procedures performed by a doctor for sterilization.
Medically necessary [means] services required to identify or treat the illness, injury, condition, or mental and nervous disorder a doctor has diagnosed or reasonably suspects. The service must be:
consistent with the symptoms, diagnosis and treatment of the patient's condition
in accordance with standards of good medical practice
required for reasons other than the convenience of the patient or the doctor
approved by the appropriate medical body or board for the illness or injury in question
at the most appropriate level of medical supply, service, or care that can be safely provided.
The fact that a service is prescribed by a doctor does not necessarily mean that the service is medically necessary.
Medical supplies or equipment [mean] supplies or equipment that are:
ordered by a physician
of no further use when medical need ends
usable only by the particular patient
not primarily for the patient's comfort or hygiene
not for environmental control
not for exercise, and
specifically manufactured for medical use.
* * *
Among the terms not defined in this or any other portion of the Plan Document are "cosmetic," "disease," and "consensus."
Petitioner Anna Leigh Miller (Anna) was born two weeks before she was due. Her delivery was normal. Her parents began to notice, immediately following her birth, that her "head tilt[ed]" to the left. Initially, they were not concerned, thinking that this "tilt" was just "temporary."
At all times material to the instant case, Anna's primary pediatrician was Ronald Romear, M.D., of Infants and
Children, P.A., in West Palm, Florida. When Dr. Romear was unavailable, Anna was seen by other pediatricians in
Dr. Romear's practice, including James Beattie, M.D.
Anna saw Dr. Romear for her two-week check-up on January 21, 2004. Dr. Romear's physical examination of Anna on this date revealed that her general appearance and head were "normal."
In March of 2004, or perhaps somewhat earlier, Anna's parents first noticed that Anna had developed a "flat head." (Anna's "head shape [was] normal at birth.")
Anna made a "sick visit" to Infants and Children, P.A., on April 28, 2004, and was seen by Dr. Beattie.
She returned, accompanied by her mother, on May 12, 2004, for a "well child visit," and was again seen by
Dr. Beattie.
During this May 12, 2004, visit, Mrs. Miller shared with Dr. Beattie that, from the time of Anna's birth, Anna was "inclined to do things facing to the left."
After examining Anna, Dr. Beattie determined that Anna had torticollis.
Torticollis literally means "twisted neck" in Latin.
It is a condition characterized by a tightening or foreshortening of the sternocleidomastoid muscle on one side of
the neck, resulting in an inability to straighten or turn the head.
Anna's torticollis was congenital (that is, present at birth).
Dr. Beattie prescribed physical therapy for Anna.
Physical therapy is the standard treatment for torticollis.
Anna's parents took Anna to the physical therapist twice a week. BCBSF deemed these services to be "covered" under the Plan and authorized payment accordingly.
In addition to taking Anna to the physical therapist, Anna's parents, in accordance with instructions they had received, did neck "stretching" exercises with Anna at home five to six times a day.
The physical therapist did her "initial evaluation" of Anna on May 20, 2004.
During this "initial evaluation," Anna's parents expressed concern about, and the physical therapist observed, "significant flattening of the left posterior aspect of [Anna's] skull resulting in moderated plagiocephalic appearance."
The physical therapist told Anna's parents about a cranial orthotic device that was available to treat this "plagiocephalic appearance."
Anna's parents knew that this device might not be covered by the Plan.
Nonetheless, during a "sick visit" Anna made to Dr. Romear's office on May 26, 2004, Mrs. Miller asked Dr. Romear what his opinion was of the device.
Dr. Romear expressed his concurrence with the physical therapist's assessment that Anna was suffering from plagiocephaly, and he referred Anna to Eric Stelnicki, M.D., a craniofacial and pediatric specialist. He also recommended that, before Anna saw Dr. Stelnicki, Anna's parents provide her with repositioning therapy at home. Repositioning therapy involves supervised "tummy time," as well as placement of the child on the side and the use of a strategically placed rolled- up towel or similar item to prevent the child from rolling over on the back and putting pressure on the flattened part of the head. It is the usual first-line treatment for plagiocephaly in those cases where the child is not "able to move readily out of placed positions."
Anna's parents followed Dr. Romear's recommendation and attempted repositioning therapy at home. They abandoned their efforts without any success after less than a month because Anna kept moving out of her "placed positions."
Instead of seeing Dr. Stelnicki, Anna saw another craniofacial and pediatric specialist in Dr. Stelnicki's practice, Drew Schnitt, M.D.
Anna's first visit with Dr. Schnitt was on June 14, 2004. That same day, after the visit, Dr. Schnitt wrote the following letter to Dr. Romear, which accurately related what had occurred during the visit and what Dr. Schnitt had found and recommended:
I am seeing Anna in my pediatric cleft and craniofacial office today. She is a 5½ month-old young lady who has been referred to me for an abnormal head shape.
She received a full review of systems, history, physical examination, and a set of anthropometric measurements in the office today. Focally, on physical examination, she has a significant amount of left deformational plagiocephaly, with left anterior ear shift, left frontal bossing, fronto-orbital complex shift, and left temporomandibular joint shift. The anterior fontanelle is open. The neck reveals right neck torticollis. The remainder of her physical appearance is within normal limits.
Due to the severity of her problem and her age, I am recommending an orthotic cranioplasty device. The preferred device is the DOC band by Cranial Technologies, Inc. I have given them an instruction sheet for range of motion exercises for the neck torticollis and we have demonstrated to them how to do these exercises.
I will see them back in one month's time for a re-evaluation. Please do not hesitate to call or contact me with any questions or concerns.
Deformational plagiocephaly (which is also known as nonsynostotic positional plagiocephaly) is plagiocephaly (that is, asymmetric or abnormal head shape) caused by external
deforming forces. It may be congenital, but, more commonly (as in Anna's case), it occurs postnatally, as a result of, for example, torticollis or forced sleeping position.
Deformational plagiocephaly is to be distinguished from another type of skull deformity, craniosynostosis (also referred to as cranial stenostosis), which, unlike deformational plagiocephaly, involves the premature fusion of skull sutures. These sutures need to stay unfused for an infant's head to grow properly and for the infant's brain to expand within the cranial skull. Their fusing prematurely can lead not only to a misshapen skull, but to other problems as well, including vision loss, developmental delay, learning difficulties, increased intracranial pressure and perhaps even herniation of the brain and death. Unlike deformational plagiocephaly, craniosynostosis "typically is a surgical problem, not a problem to try to treat with non-surgical means."
Anna was diagnosed as having deformational plagiocephaly, not craniosynostosis.
The "DOC band by Cranial Technologies, Inc.," that Dr. Schnitt prescribed for Anna to treat her deformational plagiocephaly4 is a lightweight, custom-fitted skull-molding device consisting of a semi-rigid shell bonded to a foam lining. Worn around the head 23-hours a day, it applies mild dynamic pressure to the prominent areas of the child's skull (while
leaving room for growth in the flattened areas) to produce a more symmetrical head shape.
Cranial orthotic devices, such as the DOC band, are commonly used to treat children with moderate to severe deformational plagiocephaly for whom repositioning therapy has not worked or for whom repositioning therapy is not a viable option because of their ability "to move readily out of placed positions" or because of the severity of their condition. (These devices are not, however, a treatment for torticollis.)
Surgery is performed in "multiple places around the world" to treat deformational plagiocephaly. Cranial orthotic devices, though, are more cost-effective and have fewer complications than surgical intervention.
At the time he prescribed the DOC band for Anna, Dr. Schnitt believed that this product was the "best [cranial orthotic device] on the market."
Since 1998, the DOC band has been approved by the U.S. Food and Drug Administration (FDA) as safe and effective for the treatment of deformational plagiocephaly. The FDA's approval was announced in the Federal Register, 63 FR 40650-01 (July 30, 1998). The FDA's announcement read, in pertinent part, as follows:
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is classifying the cranial orthosis into class II (special controls). The special controls that will apply to the cranial orthosis are restriction to prescription use, biocompatibility testing, and certain labeling requirements. The agency is taking this action in response to a petition submitted under the Federal, Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying cranial orthosis into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
EFFECTIVE DATE: August 31, 1998.
* * * SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are
substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the FDA regulations (21 CFR part 807).
-Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1).
FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device.
Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification.
-In accordance with section 513(f)(1) of the act, FDA issued an order on March 12, 1998, classifying the Dynamic Orthotic Cranioplasty (DOCTM Band) in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On March 31, 1998, Cranial Technologies, Inc., submitted a petition requesting classification of the DOCTM Band under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II.
In accordance with 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves,
are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition and the medical literature, FDA determined that the DOCTM Band can be classified in class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of safety and effectiveness of the device.
-The device is assigned the generic name "cranial orthosis," and it is identified as a device intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.
-FDA identified the following risks to health associated with this type of device:
(1) Skin irritation, skin breakdown and subsequent infection due to excessive pressure on the skin; (2) head and neck trauma due to alteration of the functional center of mass of the head and the additional weight of the device especially with an infant who is still developing the
ability to control his/her head and neck movements; (3) impairment of brain growth and development from mechanical restriction of cranial growth; (4) asphyxiation due to mechanical failure, poor fit, and/or excessive weight that alters the infant's ability to lift the head; (5) eye trauma due to mechanical failure, poor construction and/or inappropriate fit; and (6) contact dermatitis due to the materials used in the construction of the device.
-FDA believes that the special controls described below address these risks and provide reasonable assurance of the safety and effectiveness of the device. Therefore, on May 29, 1998, FDA issued an order to the petitioner classifying the cranial orthosis as described previously into class II subject to the special controls described below. Additionally, FDA is codifying the classification of this device by adding new
§882.5970.
-In addition to the general controls of the act, the cranial orthosis is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness of the device: (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109; (2) the labeling of the device must include: (a) Contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need to: (i) Evaluate head circumference measurements and neurological status at intervals appropriate to the infant's age and rate of head growth and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development and (ii) evaluate the skin at frequent intervals, e.g., every 3 to 4 hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need to: (i) Additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, the possible impairment of brain growth and development and skin irritation and/or breakdown; and
(iii) evaluate the structural integrity of
the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin;
(d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of the device; (e) clinician's instructions for casting the infant, for fitting the device, and for care; and (f) parent's instructions for care and use of the device; (3) the materials must be tested for biocompatibility with testing appropriate for long term direct skin contact.
* * *
V. References
-The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
Petition from Cranial Technologies, Inc., dated March 31, 1998.
Hellbusch, J. L., L. C. Hellbusch, and
R. J. Bruneteau, "Active Counter-Positioning Treatment of Deformational Plagiocephaly," Nebraska Medical Journal, vol. 80, pp. 344 to 349, 1995.
Moss, S. D. et. al., "Diagnosis and Management of the Misshapen Head in the Neonate," Pediatric Review, vol. 4, pp. 4 to 8, 1993.
-Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
List of Subjects in 21 CFR Part 882 Medical devices.
PART 882--NEUROLOGICAL DEVICES
* * *
2. Section 882.5970 is added to subpart F to read as follows:
§882.5970 Cranial orthosis.
-(a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
-(b) Classification. Class II (special controls) (prescription use in accordance with §801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).
Dated: July 21, 1998.
A year earlier, in 1997, a "consensus statement" was issued "jointly by several pediatrics organizations (including the Section of Plastic Surgery of the American Academy of Pediatrics and the American Cleft Palate/Craniofacial Society)," in which it was asserted that "deformational plagiocephaly . . . usually responds to conservative measures [such as] the use of skull molding caps."
In July of 2003, the American Academy of Pediatrics published a "clinical report" designed to provide "guidance for the clinician in rendering pediatric care" concerning the "[p]revention and [m]anagement of [p]osition [s]kull [d]eformities in [i]nfants."5 The report contained the following observations regarding "skull-molding helmets":
Skull-Molding Helmets
Several ancient civilization have used head- molding devices in infants to reshape a typically shaped skull into a different but desired skull form. Conversely, skull- molding helmets can be used to correct atypical skull shapes, and similar devices are now proposed for this purpose. However, results from 1 study suggest that repositioning infants may produce improvement in mild to moderate cases similar to that reported with external orthotic devices. Another study has linked the use or helmets with an improvement over that achieved by repositioning alone. The best response for helmets occurs in the age range of 4 to 12 months because of the greater malleability of the young infant skull bone and the normalizing effect of the rapid growth of the brain. There is less modification of the cranial configuration when used after 12 months of age. The use of helmets and other related devices seems to be beneficial primarily when there has been a lack of response to mechanical adjustments and exercises. In most situations, an improvement to repositioning and neck exercise is seen over a 2- to 3- month period if these measures are instituted as soon as the condition is recognized. Because use of skull-molding helmets incurs significant cost, further studies are needed to identify outcomes with and without them.
At the end of the report was the following "summary": Summary
In most cases, the diagnosis and successful management of deformational plagiocephaly can be assumed by the pediatrician or other primary care clinician. This includes examination for and counseling regarding deformational plagiocephaly in the newborn period and at health supervision visits during infancy, as well as monitoring for improvement or progression.
Mechanical methods, if performed early in life, may be effective in preventing further skull deformity and may reverse existing deformity. Referral to a pediatric neurosurgeon with expertise in pediatrics or a craniofacial surgeon should be considered if there is progression or lack of improvement following a trial of mechanical adjustments.
BCBSF has a written policy stating that, "[a]s a nonsurgical treatment of plagiocephaly . . . without synostosis, [the DOC band] is considered not medically necessary." This policy statement indicates that it is based on the "lack of [as of February 2004] documented functional impairment" associated with "plagiocephaly . . . without synostosis." The statement, however, does contain an acknowledgement that the "available data [as of February 2004, reveals] that the [DOC band] therapy can indeed reshape the cranium to a more normal contour."
Further support for the notion that the DOC band and similar cranial orthotic devices are effective in "reshap[ing]
the cranium to a more normal contour" is found in the "most recently published [of the] medical literature" received into evidence at hearing in the instant case: an article entitled, "Management of Deformational Plagiocephaly: Repositioning Versus Orthotic Therapy," authored by John Graham, M.D. and others. This article was published in the February 2005 edition of the Journal of Pediatrics, a "respected [peer-reviewed] journal." Based on their evaluation of the data they examined, the authors of the article concluded that, "[w]hen physical therapy and repositioning fail to treat or prevent plagiocephaly and there is more than 1 cm difference between the two cranial diagonal differences at age 6 months, orthotic therapy is effective in correcting such asymmetry," and they further concluded that "[d]elays in initiating corrective treatment until later infancy may lead to incomplete or ineffective correction even if orthotic therapy is initiated . . ."6
Anna was "cast for the DOC band" at Cranial Technologies, Inc., on June 23, 2004.
She returned with her parents to Cranial Technologies, Inc., on July 1, 2003, to try on the DOC band that had been fabricated for her. Only some "trimming adjustments" had to be made. Anna started wearing the band that day.
Anna continued wearing the DOC band (23 hours a day) until October 18, 2004.
On that date (October 18, 204), the Cranial Technologies, Inc., clinician who had been working with Anna sent Dr. Schnitt a letter advising him that Anna's DOC band treatment had been successfully completed.
Anna had obtained a "good result" from the DOC band treatment. Her cranial asymmetry had "markedly improved."
Anna's last visit to Dr. Schnitt was on November 29, 2004. That day, after the visit, Dr. Schnitt wrote the following letter to Dr. Romear, which accurately related what had occurred during the visit and what Dr. Schnitt had found and recommended:
I am seeing Anna back in my pediatric cleft and craniofacial office today. She is a young lady with left deformational plagiocephaly and right torticollis, who is here again for follow up. She is now 11 months old and was treated in the DOC band cranial molding device for four months and has been out of this since October.
She received a full review of systems, history, physical examination, and a set of anthropometric measurements in the office today. Focally on physical examination, she has a mild to moderate amount of residual left deformational plagiocephaly with left anterior ear shift, left frontal bossing, and fronto-orbital complex shift. Her anterior fontanelle remains open.
Examination of her neck reveals a minimal amount of residual right neck torticollis. The remainder of the physical examination is within normal limits.
I have had a long discussion with mom about the treatment of deformational
plagiocephaly. She has made a marked improvement since the beginning of her treatment, and mom is, overall, satisfied, but was asking about going into another helmet to try to improve things further. I have given her this option, but she has decided not to proceed with a second band. I have also advised her of the need to continue with neck range of motion exercises at least until Anna is two years old. Mom would like to continue to follow with me until she is satisfied with the torticollis outcome.
I will see her back in two to three months' time. Mom also knows to make an appointment in a more timely manner if she notices any abnormal head growth or regression. Please do not hesitate to call or contact me with any questions or concerns.
The Millers were billed $3,000.00 by Cranial Technologies, Inc., for the DOC band and related costs.
They filed a claim requesting that the bill be treated as being for services and/or supplies "covered" by the Plan.
The request was denied by BCBSF, which issued a Non- Payment Notice.
The Millers filed an unsuccessful Level I appeal with BCBSF (as provided for in the Plan Document).
They then filed a Level II appeal with Respondent (as provided for in the Plan Document).
As noted above, Respondent rejected the Millers' Level II appeal, finding that Anna's DOC band treatment was "cosmetic"
and "experimental and investigational" and not "medically necessary," as those terms are used in Plan Document.
Thereafter, at the Millers' request, an administrative hearing on their claim was held.
The preponderance of the evidence adduced at the administrative hearing establishes that Anna's DOC band treatment was "medically necessary," as that term is defined in the Plan Document, in that the evidence demonstrates the treatment was: "consistent with the symptoms, diagnosis and treatment of [her] condition" (moderate to severe deformational plagiocephaly7 that had not responded to repositioning therapy due, at least in part, to her moving out of her "placed positions"); "in accordance with standards of good medical practice"; "required for reasons other than the convenience of [Anna] or [her] doctor"; "approved by the appropriate medical body or board for the illness or injury in question" in that "pediatrics organizations" have documented their recognition of the beneficial effects devices such as the DOC band have in treating deformational plagiocephaly; and "at the most appropriate level of medical supply, service, or care that [could] be safely provided" in that repositioning therapy had already been attempted without success.
The preponderance of the evidence adduced at the administrative hearing fails to establish that Anna's DOC band
treatment was " experimental and investigational," as those terms are defined in the Plan Document. Respondent concedes (in its Proposed Recommended Order) the inapplicability of Experimental/Investigational Criterion No. 1 and Experimental/Investigational Criterion No. 2. With respect to the remaining Experimental/Investigational Criteria set forth in Plan Document's definition of "experimental or investigational services":
regarding Experimental/Investigational Criterion No. 3, while it has been shown that some "experts" believe more study of DOC band treatment is needed "to determine maximum dosage, toxicity, safety or efficacy," the record evidence is insufficient to demonstrate that DOC band treatment "is generally regarded by experts as requiring [such additional] study";
regarding Experimental/Investigational Criterion No. 4, the record evidence is insufficient to demonstrate that, according to the "most recently published medical literature of the U.S., Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices," the use of a DOC band to treat a child almost six months of age (Anna's age when she first started wearing the band) with moderate to severe deformational
plagiocephaly that has not responded to repositioning therapy is not a "safe and effective . . . treatment of th[is] condition";
regarding Experimental/Investigational Criterion No. 5, while it has been shown that "practicing doctors" do not unanimously accept the DOC band as "safe and effective" for treating deformational plagiocephaly that has not responded to repositioning therapy, the record evidence is insufficient to demonstrate that there is not a consensus or majority8 of "practicing doctors" who are of this opinion9; and
regarding Experimental/Investigational Criterion No. 6, the record evidence is insufficient to demonstrate that "practicing doctors" as a group do not "regularly" (meaning typically, but not necessarily in each and every instance, without exception10) use a DOC band or like device to treat deformational plagiocephaly that has not responded to repositioning therapy.
The preponderance of the evidence adduced at the administrative hearing establishes that Anna's DOC band treatment was "cosmetic," as that term is used in the Plan Document,11 in that it was prescribed to improve her appearance by ameliorating her deformational plagiocephaly and giving her a more natural-looking, symmetrical head shape, and it had no purpose or effect beyond changing the asymmetrical appearance of her head.
The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was the "result of a covered accident."
The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was "for correction of a congenital anomaly." While Anna's torticollis was a "congenital anomaly," her deformational plagiocephaly was not, and her DOC band treatment addressed her deformational plagiocephaly, not her torticollis.
The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was a "medically necessary procedure to correct an abnormal bodily function." While the treatment was "medically necessary" and undertaken to "correct" an abnormality, the abnormality (the asymmetrical shape of Anna's head) was structural, not functional, in nature.
The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was "for reconstruction to an area of the body that has been altered by the treatment of a disease."
Inasmuch as Anna's DOC band treatment was "cosmetic" in nature and not within any of the "specific exceptions" noted in the Plan Document, such treatment was excluded from coverage under the Plan.12
CONCLUSIONS OF LAW
DOAH has jurisdiction over the subject matter of this proceeding and of the parties hereto pursuant to Chapter 120, Florida Statutes.
Section 110.123, Florida Statutes, contains the "State Group Insurance Program Law" (Law). § 110.123(1), Fla. Stat.
The Law delegates to Respondent the "responsib[ility] for the administration of the state group insurance program."
§ 110.123(5), Fla. Stat.
The Plan is a component of the "state group insurance program."
It is a self-insured health insurance plan for state employees established pursuant to the authority delegated to Respondent in Subsection (5)(c) of the Law, which authorizes Respondent to "self-insure any plan or plans contained in the state group insurance program subject to approval based on actuarial soundness by the Office of Insurance Regulation."
Subsection (5)(c) of the Law also authorizes Respondent to "contract with an insurance company or professional administrator qualified and approved by the Office of Insurance Regulation to administer such plan." Respondent has exercised this authority and retained BCBSF to serve as the third-party administrator of the Plan.
Respondent is required, pursuant to Subsection (5)(a) of the Law, "with prior approval by the Legislature, [to] [d]etermine the benefits to be provided" in any plan within the "state group insurance program." See also Tiedemann v. Department of Management Services, 862 So. 2d 845, 847 (Fla. 4th DCA 2003)("[T]he Plan document is approved and adopted by the legislature.").
The Respondent-determined and legislatively-approved benefits to which Plan participants were entitled in 2004 are found in the Plan Document.
"[T]he Plan Document is a health insurance policy, not a rule." Hardy, 2003 WL 21905701 *5; see also § 110.123(5)(a), Fla. Stat. ("[Respondent's] determinations [concerning plan benefits and contributions], whether for a contracted plan or a self-insurance plan pursuant to paragraph (c), do not constitute rules within the meaning of s. 120.52 or final orders within the meaning of s. 120.52.").
The instant case involves a dispute between Petitioners and Respondent concerning the extent of the Plan's coverage, as spelled out in the Plan Document. At issue is whether Anna's DOC band treatment was covered under the Plan.
In resolving this dispute, the following maxims should be taken into consideration and applied: "while an insured or beneficiary carries the burden of proving coverage under a
policy, the insurer bears the burden of proving applicability of a claimed policy exclusion" (Herrera v. C.A. Seguros Catatumbo, 844 So. 2d 664, 668 (Fla. 3d DCA 2003)); "the insured has the burden to prove an exception to an exclusion contained within an insurance policy" (Florida Windstorm Underwriting v. Gajwani, -- So. 2d-- , 2005 WL 1109465 *4 (Fla. 3d DCA May 11, 2005));
"principles governing the construction of insurance contracts dictate that '[w]hen construing an insurance policy to determine coverage the pertinent provisions should be read in pari materia.'" (State Farm Fire & Casualty Co. v. CTC Development Corporation, 720 So. 2d 1072, 1075 (Fla. 1998))13; "[w]here a clause in an insurance contract is unambiguous the language requires no special construction and should be given the meaning which it clearly expresses" (Weldon v. All American Life Insurance Co., 605 So. 2d 911, 914 (Fla. 2d DCA 1992))14; "[i]f the relevant policy language is susceptible to more than one reasonable interpretation, one providing coverage and the another limiting coverage, the insurance policy is considered ambiguous" (Auto-Owners Insurance Co. v. Anderson, 756 So. 2d 29, 34 (Fla. 2000)); "[t]he lack of a definition of an operative term does not, by itself, create ambiguity" (General Star Indemnity Co., 874 So. 2d at 30)); "where policy language is [reasonably] subject to differing interpretations, the term should be construed liberally in favor of the insured and
strictly against the insurer" (State Farm Fire & Casualty Co., 720 So. 2d at 1076); and "[e]xclusionary clauses in insurance policies are construed more strictly than coverage clauses" (Purrelli v. State Farm Fire and Casualty Co., 698 So. 2d 618, 620 (Fla. 2d DCA 1997)).
Considering and applying these maxims, it is concluded that Respondent met its burden of proving that Anna's DOC band treatment was a "cosmetic . . . treatment," within the meaning of the Plan Document; Petitioners failed to establish the applicability of any of the "specific exceptions" to the Plan Document's "cosmetic . . . treatment" exclusion; and, accordingly, Anna's DOC band treatment was excluded from coverage under the Plan and thus the Millers' claim was properly denied by BCBSF.
Based on the foregoing Findings of Fact and Conclusions of Law, it is
RECOMMENDED that Respondent enter a final order sustaining the denial of the claim at issue in the instant case.
DONE AND ENTERED this 9th day of November, 2005, in Tallahassee, Leon County, Florida.
S
STUART M. LERNER
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 9th day of November, 2005.
ENDNOTE
1/ All references in this Recommended Order to Florida Statutes are to Florida Statutes (2005).
2/ The hearing was originally scheduled for July 25, 2005, but was continued at Petitioners' request.
3/ The undersigned has accepted these factual stipulations. See Columbia Bank for Cooperatives v. Okeelanta Sugar Cooperative,
52 So. 2d 670, 673 (Fla. 1951)("When a case is tried upon stipulated facts the stipulation is conclusive upon both the trial and appellate courts in respect to matters which may validly be made the subject of stipulation. Indeed, on appeal neither party will be heard to suggest that the facts were other than as stipulated or that any material facts w[ere] omitted"); Schrimsher v. School Board of Palm Beach County, 694 So. 2d 856, 863 (Fla. 4th DCA 1997)("The hearing officer is bound by the parties' stipulations."); and Palm Beach Community College v.
Department of Administration, Division of Retirement, 579 So. 2d 300, 302 (Fla. 4th DCA 1991)("When the parties agree that a case is to be tried upon stipulated facts, the stipulation is binding not only upon the parties but also upon the trial and reviewing courts. In addition, no other or different facts will be presumed to exist.").
4/ In their Proposed Recommended Orders, Petitioners propose that the undersigned find, among other things, that a "DOC band can be used to rule out cranial stenostosis [craniosynostosis]." The record evidence, however, is insufficient to support such a finding; nor does it establish that Dr. Schnitt prescribed the DOC band for Anna for any purpose other than to treat her deformational plagiocephaly.
5/ The report contained the following footnote clarifying the "guidance" given:
The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical care.
Variations, taking into account individual circumstances, may be appropriate.
6/ In their article, the authors acknowledged the "[l]imitations to this study," which included "lack of follow-up beyond the first year of life, lack of random assignment into treatment groups, and inability to quantify how the impact of small statistically significant differences in outcome might relate to parental perceptions of cosmetic significance."
7/ Since deformational plagiocephaly is a "disease" (a term that is not defined in the Plan Document, but which Dorland's Illustrated Medical Dictionary defines as "any deviation from or interruption of the normal structure or function of a part, organ, or system of the body as manifested by characteristic symptoms and signs" (emphasis supplied)), it also constitutes a "condition" and "illness," as those terms are used in the Plan Document. See, e.g., Cash v. Universal Rivet, Inc., 616 So. 2d 446, 448 (Fla. 1993)(definition in Dorland's Illustrated Medical Dictionary relied upon to ascertain meaning of term used, but not defined, in workers' compensation statute).
8/ "Consensus is an ambiguous term. It may mean unanimity or it may mean majority." Liles v. State, 702 P.2d 1025, 1039 (Okla.
Crim. App. 1985)(Parks, J., dissenting); see also Gil v. Department of Management Services, No. 04-2370, 2004 WL 2683126
*3 (Fla. DOAH November 22, 2004)(Recommended Order)("'Consensus' is defined as: '1.a. general agreement: UNANIMITY. . . [,] b. the judgment arrived at by most of those concerned[,] and 2. group solidarity in sentiment and belief.'"). In accordance with the maxims of insurance policy construction set out in the Conclusions of Law of this Recommended Order, this ambiguity must be resolved in favor of Petitioners and against Respondent.
9/ In Hardy v. Department of Management Services, No. 03-0975, 2003 WL 21905701 *4 (Fla. DOAH August 6, 2003)(Recommended Order), the Administrative Law Judge made the following cogent observations regarding Experimental/Investigational Criteria Nos. 3 and 5:
The undersigned believes that questions such as whether a treatment "is generally regarded by experts as requiring more study" or "is not accepted in consensus by practicing doctors" would be more accurately and persuasively answered by experts in the field of polling than by medical doctors.
What is needed to produce reliable and persuasive evidence concerning how "experts" generally regard the Racz Procedure or
what the consensus of "practicing doctors" is regarding the safety and efficacy of this particular treatment----is a scientific survey of such "experts" or "practicing doctors" based on random sampling.
10/ See France v. Munson, 3 A.2d 78, 81 (Conn. 1938)("In common usage a practice is often spoken of as 'regular' although not always followed and the word admits of occasional variation.").
11/ It appears that Petitioners and Respondent are in agreement that the term "cosmetic," as used in the Plan Document, means affecting appearance only.
12/ The facts of the instant case are distinguishable from those present in Bynum v. Cigna Healthcare of North Carolina, Inc.,
287 F.3d 305 (4th Cir. 2002), an ERISA case relied upon by Petitioners in which an eligible dependent's DOC band treatment was held to not fall within the "cosmetic" treatment exclusion
contained in her mother's health insurance policy, but rather to be covered by the policy. In Bynum, unlike in the instant case, the evidentiary record was apparently sufficient to support a finding that the DOC band treatment "constituted treatment for a congenital birth defect" and "was not utilized for the sole purpose of providing [the treated child] with an aesthetically pleasing, symmetrical head shape." It is also worthy of note that in Bynum the Fourth Circuit found it significant that the DOC band treatment was undertaken with "the added hope that it might prevent the onset of serious abnormalities often associated with [the treated child's] birth defect." While the health insurance plan in Bynum may not have excluded from coverage "[a]ny services provided for preventative care," such an exclusion is contained in the Plan Document that controls the instant case. Id. at 314.
13/ See also General Star Indemnity Co. v. West Florida Village Inn, Inc., 874 So. 2d 26, 30 (Fla. 2d DCA 2004)("[A] single policy provision should not be considered in isolation, but rather, the contract shall be construed according to the entirety of its terms as set forth in the policy and as amplified by the policy application, endorsements, or riders.").
14/ See also Siegle v. Progressive Consumers Insurance Co., 819 So. 2d 732, 735 (Fla. 2002)("[A]n insurance contract is to be construed in accordance with the plain language of the
policy. . . . When an insurance contract is not ambiguous, it must be given effect as written."); and Lindheimer v. St. Paul Fire and Marine Insurance. Co., 643 So. 2d 636, 638 (Fla. 3d DCA 1994)("[T]he terms of [an insurance] contract must be given their everyday meaning and read in light of the skill and experience of ordinary people.").
COPIES FURNISHED:
Clark W. Smith, Esquire Paxton & Smith, P.A., Barristers Building, Suite 500 1615 Forum Place
West Palm Beach, Florida 33401
Sonja P. Mathews, Esquire Office of the General Counsel
Department of Management Services
4050 Esplanade Way, Suite 160
Tallahassee, Florida 32399-0950
Tom Lewis, Jr., Secretary Department of Management Services 4050 Esplanade Way
Tallahassee, Florida 32399-0950
Alberto Dominguez, Esquire Department of Management Services 4050 Esplanade Way
Tallahassee, Florida 32399-0950
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
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.
| Issue Date | Document | Summary |
|---|---|---|
| Nov. 09, 2005 | Recommended Order | A Dynamic Orthotic Cranioplasty band to treat deformational plagiocephaly is excluded from coverage under the state employee health insurance plan, inasmuch as it constitutes "cosmetic" treatment. |
DEPARTMENT OF HEALTH, BOARD OF OSTEOPATHIC MEDICINE vs ALFRED EVERSLEY BOYCE, D.O., 05-001851 (2005)
BOARD OF MEDICINE vs BARBARA ANNE MAZZELLA, 05-001851 (2005)
ANDRES GIL vs DEPARTMENT OF MANAGEMENT SERVICES, 05-001851 (2005)
BOARD OF PODIATRY vs. MARVIN E. LOWENHARDT, 05-001851 (2005)
FLORIDA MEDICAL ASSOCIATION vs DEPARTMENT OF HEALTH, BOARD OF PODIATRIC MEDICINE, 05-001851 (2005)
