The Issue Whether the surgery to correct complications from non- covered cosmetic surgery are covered under the State of Florida self-insured health plan?
Findings Of Fact Sharon Lett, Petitioner, was initially hired by the State of Florida on October 1, 1986, and began participating in the State's self-insured health plan known as the State Employees' Preferred Provider Organization Plan, or State PPO Plan. Pre-existing conditions were covered after 365 days. In June 1985, Lett had bilateral silicone breast implants placed under the pectoral muscles. This occurred before she was covered under any of the state-sponsored health insurance plans. The implant surgery was performed for purely cosmetic reasons. Lett continued to work for the State until her retirement and was covered under the State's health insurance plan. Upon her retirement she continued her coverage under the State PPO Plan. In 1997, while covered by the plan, Lett sought medical intervention for problems related to the implants. She had concerns about the implants leaking and there were indications in the form of "lumps" and x-ray images which indicated the implants were leaking. There are some clinical studies which indicate that leaking implants are a potential health problem. The "lumps" and leakage decrease the ability to properly diagnose breast cancer. For patients who have a higher risk for breast cancer, these difficulties in diagnosis place the implanted patients at greater risk. Lett is diagnosed as being at greater risk for breast cancer. Both of her implants have leaked. Lett sought removal of the implants beginning in 1997. The State's PPO Plan has denied approval of the surgical procedure to remove the implants because the implant surgery was originally for cosmetic purposes. The latest denial was by letter dated September 27, 2002. The Division of State Group Insurance (DSGI) is responsible for the management of the State's group insurance programs, to include the PPO Plan. The State's PPO Plan is administered under contract by Florida Blue Cross and Blue Shield. In support of her latest request for payment for the surgery to remove the implants, Lett provided DSGI the following: Medical Report of Marguerite Barnett, M.D., (Respondent's Exhibit 4), dated May 23, 2002. Clinical Record Progress Notes by Frank B. Vasey, M.D., for visit on April 15, 2002. Lett also provided a diagnostic report by Mary E. Swain, M.D., dated June 1, 2000. The DSGI agrees that the reports of Drs. Barnett and Vasey accurately describe Petitioner's medical condition and accurately identify the etiology of the condition that necessitates the surgery Petitioner seeks. At the time Lett initially enrolled in the State PPO Plan, the benefits document in effect was State of Florida Employees Group Health Self Insurance Plan Benefit Document, as Amended on October 1, 1986. Section VII, Exclusions, of the 1986 Benefits Document provides: Services for cosmetic surgery or treatment unless the result of a covered accident as provided in Subsection VIII.A. However, cosmetic surgery is a covered service if it is: in connection with the correction of a congenital anomaly for an eligible dependent born while family coverage is in force and performed while the Plan is in force, a medically necessary procedure in the correction of an abnormal bodily function, or for reconstruction to an area of the body which has been altered by the treatment of a disease, provided such alteration occurred while the insured was covered under the Plan. Section VIII, Limitations, of the 1986 Benefits Document provides: The following limitations shall apply under the Plan: A. Cosmetic surgery or treatment necessary for the repair or alleviation of damage to an insured is covered by the Plan if such surgery or treatment is the result of an accident sustained while the insured is covered under the Plan and actually performed while the Plan is in force, except as provided under Section XIII and XIV of this Benefit Document. Section XIII deals with termination of an insured's coverage and is not applicable here. Section XIV deals with termination of the program and is not applicable here. At the time Lett requested approval for the surgery to remove the implants, the benefits document in effect was State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document effective January 1, 2000 (hereafter, 2000 Benefits Document). The 2000 Benefits Document states regarding services not covered by the plan that cosmetic surgery is not covered unless it is: A result of a covered accident if the accident happens 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 born while the employee has family coverage 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, provided the alteration occurred while the person was covered by this health insurance plan, For breast reconstructive surgery and the prosthetic devices related to a mastectomy. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons as determined by a licensed physician, and "breast reconstructive surgery" means surgery to reestablish symmetry between the two breast, . . . Complications resulting from non-covered services, except complications of pregnancy defined on pages 49-50, are excluded from coverage generally. See 2000 Benefit Document, page 31, paragraph 53. It is noted that the 1986 Benefit Document does not have a provision similar to that cited in paragraph 21, above. Under the 1986 Benefit Document, cosmetic surgery would not have been covered, but surgery necessary to address complications from non-covered services was not limited or excluded. The problems suffered by Lett did not arise until after the time limit excluding pre-existing conditions had expired or run.
Recommendation Based upon the foregoing findings of fact and conclusions of law it is RECOMMENDED: That Petitioner's Petition be dismissed. DONE AND ENTERED this 27th day of February, 2004, in Tallahassee, Leon County, Florida. S STEPHEN F. DEAN 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 27th day of February, 2004. COPIES FURNISHED: Sharon Lett 240 Starmount Drive Tallahassee, Florida 32303 Sonja P. Mathews, Esquire Department of Management Services Office of the General Counsel 4050 Esplanade Way, Suite 260 Tallahassee, Florida 32399-0950 William Simon, Secretary Department of Management Services 4050 Esplanade Way, Suite 260 Tallahassee, Florida 32399-0950 Alberto Dominguez, General Counsel Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950
The Issue Whether the School Board of Broward County's decision to award the contract in response to Request for Proposals, No. 210139V, for Group Medical Benefits, to Humana, Inc., Humana Medical Plan, Inc., and Humana Health Insurance Company of Florida, Inc. (collectively called "Humana") is contrary to the agency's governing statutes, the agency's rules or policies, or the request for proposal specifications.
Findings Of Fact The Procurement The procurement at issue is for group employee medical insurance benefits for SBBC employees and their dependents. As one of its employee benefits, the SBBC provides health care insurance to approximately 26,000 employees. Generally, an employee must pay five percent of the premium if he or she is enrolled in a plan, other than a health maintenance organization plan, whose premium cost exceeds $212 per month. The employees can also purchase coverage for their eligible dependents. On July 10, 2000, the SBBC issued RFP No. 21-139V entitled "Group Medical Benefits for School Board Employees" (the "RFP"). On July 31, 2000, the SBBC released Addendum Number One to the RFP that consisted of written responses to proposers' questions and minor changes to the RFP. Proposers were permitted to offer any or all of three healthcare delivery models or any combination of the three: a health maintenance organization ("HMO") model; a point of services ("POS") model; and a preferred provider organization ("PPO") model. SBBC reserved the right to contract for one or more models independently or contract for multiple models from the same proposer. SBBC received proposals from seven companies, including Humana, AvMed, HIP Health Plan of Florida, Inc. ("HIP"), and United Healthcare of Florida ("United"), on August 18, 2000, as scheduled by the RFP. The School Board evaluated the proposals through the Superintendent's Insurance Advisory Committee (the "Insurance Committee"), who then made a recommendation to the Superintendent, who in turn made a recommendation to the School Board. Prior to the issuance of this RFP, during the year 2000, health care coverage was provided to employees of SBBC through contracts with HIP and with Foundation Health, a Florida Health Plan ("Foundation"). Those contracts, at guaranteed premium rates, were to remain in effect through December 31, 2001. Due to enduring problems with HIP and Foundation, the School Board became concerned that both companies may be unable to continue to perform under their contract. In the course of communication with SBBC during 2000, Foundation requested to be released from further obligations as of December 31, 2000, under its existing contract awarded June 15, 1999, under the previously issued RFP No. 99-100E. The open enrollment period for 2001 health plan election by SBBC employees was scheduled for October 30, 2000. While HIP participated in the open enrollment process whereby SBBC employees could select their health care plans, Foundation did not participate. SBBC filed a lawsuit against Foundation on October 23, 2000, for relief including breach of contract. In June 2000, HIP was declared "impaired" by the Florida Department of Insurance ("DOI") and ceased the enrollment of new members as required for impaired insurers. DOI placed HIP under "administrative supervision" pending a sale or liquidation of the company. In a letter dated September 6, 2000, DOI notified SBBC that HIP’s enrollment of new members was suspended pending an acquisition or cash infusion to cure the financial deficit. Shortly thereafter, in a letter dated October 18, 2000, DOI notified SBBC that HIP had been acquired by a new owner, was free of the restrictions noted in the September 6, 2000, letter, and permitted to enroll new members. HIP participated in the employee enrollment for the 2001 calendar year. Issuance of RFP No. 21-139V In light of the circumstances surrounding its incumbent vendors for group medical benefits, SBBC decided to issue a new RFP for new contracts providing group medical benefits for SBBC employees and dependents. On July 10, 2000, SBBC released RFP No. 21-139V entitled "Group Medical Benefits for School Board Employees." RFP Content Article 1, entitled "Required Response Form," requested general information about each proposer seeking to bid. Article 2.0 of the RFP entitled "Introduction" authorized proposers to quote any or all of three delivery models (HMO, POS, and PPO) for the employees and retiree groups and reserved the right for SBBC to award additional points to proposers who quoted all three delivery models. It also authorized SBBC to "contract for one or more models independently or to contract for multiple models from the same vendor." Article 2.0 of the RFP further stated that "Proposers must bid on the Current Plan Designs" and referred proposers to the then existing HIP certificates of coverage contained in Attachment G of the RFP. Proposers were invited to include one alternate plan for each delivery model quoted and referred proposers to a skeletal framework for such models contained in Attachment N of the RFP. Article 3, entitled "General Conditions," provided the RFP's deadlines and conditions. Section 3.7 indicated that "In a competitive procurement process no submissions made after the proposal opening, amending or supplementing the proposal shall be considered." However, Section 3.8 specifically authorized the Evaluation Committee and/or SBBC to "waive irregularities or technicalities in proposals received." Article 4 and Article 5 did not appear in the RFP at issue. Article 6, entitled "Interpretations," referred proposers who had questions to the SBBC purchasing department. Article 7 of the RFP was clearly marked as "Minimum Eligibility Criteria." In past RFP's, SBBC included extensive minimum eligibility criteria for proposers seeking to bid. In the RFP at issue, SBBC minimized the criteria to encourage competing proposals and to afford flexibility to SBBC in solving its immediate employee health care needs. Accordingly, Article 7 set forth only one minimum eligibility criterion. It stated: In order to be considered eligible for this assignment, proposer shall meet or exceed the following criteria: The proposer shall be licensed in good standing in the State of Florida to conduct health insurance business, and/or be a non- profit health care corporation licensed to transact business in Florida. All proposals which complied with Article 7 were considered by the agency. Any deviations in the proposals were contemplated by the Insurance Committee and considered in scoring the proposals. Article 8 of the RFP, entitled "Information to be included in the submitted proposal," requested applicants to organize their proposals in the specified manner. Subsections of Article 8 requested a Title Page (8.1), Table of Contents (8.2), Letter of Transmittal (8.3), Response Form (8.4), Notice Provision (8.5), and an Addenda Letter (8.6). Additional subsections in Article 8 of the RFP requested applicants to provide validation of their minimum eligibility (8.7), responses to the Attachment E questionnaire for each proposed plan (8.8), records of their experience and qualifications (8.9), a detailed plan for providing SBBC's requested scope of services (8.10), and a cost proposal for each plan (8.11). Noteworthy, Subsection 8.10.9 of Section 8.10 provided the applicant with proposed "assumptions/requirements" that "should be considered" when preparing a response to the RFP. For each proposed assumption listed in Subsection 8.10.9, three separate response columns were provided bearing the headings "Yes, Can Comply"; "Yes, Can comply but with deviations"; and "No, Cannot comply." For example, included within Subsection 8.10.9’s list of proposed assumptions to be considered by the applicant was the following: Variations in actual enrollment shall have no effect on your rate quotation. Your proposal shall be valid regardless of the actual enrollment mix, number of proposers, number of plan designs or outcome. By providing three separate response columns in the RFP, SBBC clearly invited a range of responses from proposers that would permit a proposal to differ from the proposed "assumptions/requirements." Although Section 8.11 of the RFP stated, in part, that "[n]o conditions or qualifications (e.g. participation requirement) to the quoted rates are acceptable," only Section 8.7 specifically addressed the disqualification of a proposal. Section 8.7, entitled "Minimum Eligibility" clearly restated that the "Proposer shall validate each criteria stated in Section 7 as required in said Section. Failure to comply with the requirements of Section 7 will disqualify the proposal from further consideration." Disqualification arose not for non- compliance with an Article 8 component, but rather for a failure to satisfy the minimum eligibility criteria contained in Article 7. Section 8.10 of the RFP entitled "Scope of Services Provided," requested an explanation of the proposed plan. Specifically, it stated: The following services are requested by SBBC in the provision of group medical coverage to its employees and retirees (including KID’s programs). Clearly describe how the proposer can accomplish each of the following Scope of Services provided below. . . . Moreover, Article 9 of the RFP, entitled "Evaluation of Proposals," clearly reserved to the Insurance Committee "the right to short list the proposers, interview them, and negotiate any term, condition, specification or price with the selected proposer(s)." The wide latitude of discretion plainly conferred upon the Insurance Committee by this provision is consistent with the minimum eligibility criteria contained in Article 7 and with the reservation of the right in Article 2 to contract for one or more models independently or contract for multiple models from the same vendor(s). Article 10 of the RFP, entitled "Special Conditions" detailed general conditions of the RFP. Specifically, Section 10.37 of the RFP, entitled "Acceptance and Rejection of Proposals," provided that a proposal "may be rejected if it does not conform to the rules or requirements contained in this RFP." This section listed permissive grounds for possible RFP rejection including conditional proposals and instances in which the "proposer adds provisions reserving the right to accept or reject an award or to enter into a contract pursuant to an award or adds provisions contrary to those in the RFP." Finally, Article 11 of the RFP, entitled "Requirements of Agreement," clearly and separately identified a list of "provisions that are not subject to negotiation." There is no evidence in the record that any proposer included provisions in its proposal which conflicted with Article 11. Issuance of Addendum Number One Shortly after SBBC released the RFP, at least two proposers sought clarification of Subsection 10.37.6. On July 31, 2000, SBBC released Addendum Number One to the RFP which responded to proposers’ questions and made minor changes to the RFP. In the Addendum, SBBC addressed the following question: "Is SBBC stating in this section that ANY deviations from the Proposer, in response to RFP 21-139V, will result in the Proposer’s automatic rejection from this bid process? Please clarify." In response, the SBBC stated: There are provisions in this RFP which provide proposers the opportunity to submit an additional plan design for each delivery model quoted. See Section 2.0. However, a proposer who adds provisions to its proposals reserving the right to accept or reject an award, reserving the right to enter into a contract pursuant to an award, or add[s] provisions in its proposal which are contrary to the wording in the RFP, as amended, would have its proposal rejected. The Proposals On August 18, 2000, proposals were submitted to SBBC’s Purchasing Department. SBBC received proposals from the following seven (7) proposers: AvMed; Beacon Health Plans, Inc. ("Beacon"); HIP; Humana; The Maxon Company ("Maxon"), UniPsych Corp. (UniPsych"); and United Healthcare of Florida ("United"). The Humana Proposal In its proposal, Humana responded "Please see comments on rate pages (Attachment D)" under the "No, Cannot comply" column in response to the proposed "assumption/requirement" in Subsection 8.10.9 of the RFP that "variations in actual enrollment shall have no effect on your rate quotation. Your proposal shall be valid regardless of the final enrollment mix, number of proposers, number of plan designs or outcome." Humana’s response to this portion of the RFP was identified to the Insurance Committee as a deviation from the RFP and was considered when scoring the proposals. The Financial Response Forms contained in Attachment D of Humana’s proposal for HMO, POS, PPO and modified PPO health products that were referenced in its response to Subsection 8.10.9 stated as follows: The following contingencies apply: Rates and benefits are contingent upon a minimum of 10,000 employees enrolled in Humana plans. Proposed rates and benefits assume a maximum of two carriers. The competing carrier must have similar benefits, covered services, and plan types. SBBC’s incentive strategy must be such that the amount the employee is required to contribute to the Humana plan shall be equal to or less than the employee’s contribution toward the competitor’s plan. These provisions were actuarial assumptions reasonably used by Humana to price the benefits proposed to SBBC. Humana’s response to this portion of the RFP was identified to the Insurance Committee as a deviation from the RFP and considered when scoring the proposals. In response to Subsection 8.10.9 of the RFP, Humana also responded to the proposed "assumptions/requirements" that "[a]ctively-at-work provisions shall be waived for all participants" and that "[t]here shall be no exclusion provisions for pre-existing conditions, except for late entrants" by stating under the heading, "Yes, Can comply but with deviations" that it will waive those terms "if Humana is offered as full replacement." Humana’s response to these portions of the RFP was identified to the Insurance Committee as deviations from the RFP and considered when scoring the proposals. In its formal written protest, AvMed, in part, contests the portion of Humana’s proposal that states "[p]erformance guarantees will apply only if a minimum of 10,000 employees enroll in Humana plans." This response is consistent with the compliance matrix in Subsection 8.10.9 and with Section 10.42 of the RFP which stated that "SBBC may negotiate performance standards and performance guarantees with the selected proposer(s)." In addition, the performance standards guarantees, contained in Attachment K of the RFP, invited proposers to "[p]lease review the outlined proposed performance standards and liquidated damages." Although Humana labeled each plan design it proposed as an "alternate plan," it clearly sought to closely match them with the current HIP certificates of coverage contained in Attachment G of the RFP. While structured differently, Humana’s HMO (Alternative Plan 1) generally matched the benefits contained in the current HIP HMO certificate of coverage with minor variances in certain benefits. Humana offered slightly modified benefits by eliminating a $300 hearing aid benefit, requiring a co-payment of $10 for maternity office visits, providing a three-tier structure for retail and mail order prescriptions, slightly increasing the out-of-pocket maximums, and eliminating a benefit for mildly ill child care services. Humana however, offered enhanced benefits by including coverage for non-formulary retail and mail order prescriptions, and abolishing the limit on days/visits for physical, speech and occupational therapies, as well as home health care visits, and infertility treatment. The proposed modifications were considered by the Insurance Committee. Similarly, Humana’s proposed POS (Alternative Plan 1) generally matched the benefits contained in the current HIP POS certificate of coverage with minor differences. Humana offered modified benefits by omitting a $300 hearing aid benefit, using a three-tier structure for retail and mail order prescriptions, reducing visits for in-network mental health outpatient services, increasing the co-payment for in-network inpatient substance abuse, omitting coverage for in-network infertility treatment, increasing the co-payment for non-surgical spine and back treatment and limiting visits per year for the same, placing a maximum on benefits for in-network and out-of-network hospice care, and placing a $5 million limit on lifetime benefits. On the other hand, Humana offered enhanced benefits by eliminating limitations for in-network or out-of-network rehabilitation visits, providing coverage of out-of-network ambulance care, increasing covered days for skilled nursing facilities, increasing visits for home health care and omitting co-payments for in-network care and increasing covered visits and omitting benefit limits for out-of-network care, and increasing the out-of-network lifetime benefits limit. Humana’s HMO and POS proposals also offered networks of acute care hospitals, primary care physicians, and specialty physicians, that were far superior to other proposals. Humana's proposals were thoroughly considered by the Insurance Committee during the evaluation process. Moreover, due to past problems with the SBBC incumbent providers, a financial rating report of the proposers was given to the Insurance Committee. Humana was reported to have an AM Best rating of "A- (excellent)." Ratings of B+ and above represent those companies that are considered secure in their ability to meet their ongoing obligations to members. The AvMed Proposal The AvMed proposal also contained health care delivery products corresponding to the Current Plan Designs contained in Attachment N of the RFP. However, their proposal failed to closely match the current HIP certificates of coverage contained in Attachment G of the RFP. The HMO product offered to SBBC by AvMed differed from the HIP model of coverage, at minimum, in the following respects: Current Benefit Description Certificate AvMed Proposal Maternity outpatient visits No co-payment Per visit $10 co-payment per visit Family Planning – sterilization $10 co-payment (office visit) $50 co-payment (hospital) $100 co-payment Physical, Speech and Occupational Therapy No co-payment 60 days from 1st day of treatment for acute $10 co-payment 24 days per condition Skilled Nursing Facility No co-payment 30 days/ $25 co-payment per day, up to calendar year; 100 days/ lifetime 20 days/ contract year Second Medical Opinion from No co-payment $10 co-payment a participating provider per visit Testing for Learning $200 co-payment No Benefits Disabilities for children 5 years and older Second Medical Opinion from 40% of No Benefits a Non-participating charges provider within the service area Durable Medical Equipment No co-payment $50 co-payment $5,000 annual $500 annual limit limit Mildly Ill Child Care $10 co-payment No Benefits Services (a qualified Limited to 3 participating provider days per arranged by carrier to calendar year per care for a sick child family coverage (up to age 12) during subscriber normal business hours Infertility Treatment No co-payment No Benefits (ncludes testing, counseling, $6,000 max per artificial insemination, lifetime in-vitro fertilization and injectable drugs) Prescription Drugs – $3 = 90 day $9 = 90 day Mail Order supply supply AvMed's proposed differences in benefits were identified and evaluated by the Insurance Committee during the evaluation of proposals. Moreover, the POS product proposed by AvMed as corresponding to the Current Plan Design differed in the following respects: Benefit Description Current Certificate AvMed Proposal Family Planning – Sterilization (in network) $10 co-payment (office) $200 co-payment (hospital) $10 co-payment per visit Family Planning – sterilization (out-of-network) $10 co-payment (office) $200 co-payment No Benefits (hospital) Physical, Speech and Occupational Therapy visits (in-network) No co-payment 20 visits per condition 80 visits per year $10 co-payment 24 (in-network) condition Skilled Nursing Facility (in-network) No co-payment up to 30 days calendar year $25 co-payment per day, up to 20 days/ contract year Second Medical Opinion from a participating provider No co-payment $10 co-payment Second Medical Opinion from non-participating provider within Service area a No co-payment No Benefits Testing for Learning Disabilities for children 5 years and older No co-payment No Benefits Durable Medical Equipment (in-network) No co-payment $5,000 annual Limit $50 co-payment $500 annual limit Durable Medical Equipment 65% of URC After Deductible $5,000 annual $50 co-payment $500 annual limit limit Mildly Ill Child Care Services (a qualified $10 co-payment limited to 3 No Benefits participating provider days per calendar arranged by carrier to care year per family for a sick child (up to coverage subscriber age 12) during normal business hours Infertility treatment No co-payment No Benefits (includes testing, counseling, $6,000 max per artificial insemination, lifetime in-vitro fertilization and injectable drugs)(in-network) Hospice Care (out-of-network) No co-payment No Benefits 210 days lifetime limit Prescription Drugs – Retail $7 (formulary) No Benefits (out-of-network) $21 (non-formulary) Prescription Drugs – mail $7 (formulary) $21 (formulary) order (in-network) $21 (non- $63 formulary) (non-formulary) Similarly, AvMed's proposed differences in benefits were thoroughly considered by the Insurance Committee during the evaluation process. AvMed submitted additional deviations in its proposal. Subsection 8.10.1 of the RFP listed a scope of services and requested each proposer to describe how their proposal could accomplish each item. One service listed was "Customer service lines for employees in Area Code 954, as well as a toll-free line for employees residing outside the 954 Area Code." The provision of customer service lines within the 954 area code is important for serving SBBC’s employees as many telephones within the school system will not dial an outside call in excess of 7 digits. In responding to Subsection 8.10.1 of its proposal, AvMed stated that it "offers toll free customer service lines for all members" which is "accessible from all locations inside and outside of the 954 area code." Due to the inability to access 800 service on several school properties, this response was identified to the Insurance Committee as a deviation from the provisions of the RFP and considered when scoring the proposals. Subsection 8.10.2 of the RFP requested proposers to describe how they can "participate and share in the cost of an independent employee satisfaction survey." In its proposal, AvMed stated its willingness to participate in the survey but was silent as to sharing in the survey cost. AvMed’s response was identified to the Insurance Committee as a deviation from the RFP and considered when scoring the proposals. Although Attachment E of the RFP instructed each proposer to "[p]rovide your organization’s most recent financial ratings (e.g., Moody’s, S&P, AM Best)," AvMed failed to provide it. As a result, an independent report was prepared and submitted to the Insurance Committee during the evaluation process reflecting the AM Best rating of AvMed’s financial status as "Bq (Fair)." The rating indicated that AvMed had not solicited the Best’s rating but was derived from publicly available financial data as well as other reliable information. Ratings of B and below are considered vulnerable with respect to their ability to meet their ongoing obligations to members. Specifically, a "B" rating denotes an ability to meet current obligations to members, but financial strength is vulnerable to adverse changes in underwriting and economic conditions. The HIP Proposal In its proposal, HIP also responded to the portion of Subsection 8.10.9 concerning "variations in actual enrollment" under the response column marked "Yes, can Comply but with deviations." HIP’s response stated, "At the request of the School Board of Broward County, HIP is willing to work with the School Board to reduce PPO rates." Its response comported with Subsection 8.10.9, was submitted to the Insurance Committee as a deviation from the RFP, and was considered when scoring the proposals. Section 10.42 of the RFP stated that SBBC may negotiate performance standards and guarantees with the selected proposer(s). In its Proposal, HIP agreed to this provision and responded that it had reviewed and understood its obligations under Section 10.8 of the RFP which concerned, in part, damages upon provision of non-conforming services. Similarly, HIP indicated a willingness to negotiate performance guarantees in its response to Attachment K of the RFP. The United Healthcare Proposal In its formal written protest, AvMed argued that portions of the United proposal were non-responsive requiring rejection of the proposal. In its proposal, United described certain rating assumptions utilized by its actuaries to prepare the rate quoted to SBBC. The assumptions generally concerned circumstances and the status quo existing under SBBC’s current providers and included an assumption that 50 percent of the eligible employees would participate in the coverage. The assumptions were identified to the Insurance Committee as deviations from the RFP and were considered when scoring the proposals. United also reserved the right to revise its quotation if the benefits or service requirements were changed. United Healthcare's reservation did not render conditional the rates offered for the benefits specified in the proposal and is consistent with Article 2 of the RFP which notified proposers that benefit levels may be subject to change due to changes in SBBC’s collective bargaining agreements. Subsection 10.37.2 of the RFP provides that a proposer will not be excused from "full compliance with the RFP specifications and other contract requirements if the proposer is awarded the contract." United agreed to Subsection 10.37.2 in its proposal and, consistent with Section 9.4, acknowledged that a formal agreement was to be negotiated and executed. United also stated that its proposal relied upon information provided by SBBC. In the event that such information proved false, United reserved the right to adjust its proposal. Section 10.16 of the RFP set forth the priority of documents in the event of a conflict of terms. While United suggested the parties conduct a conference to discuss any disputes, it concurred that the process described in Section 10.16 should be used as the primary method for resolution. Section 10.19 of the RFP included a hold harmless agreement. The provision included a statement that the proposer would be liable for damages or loss to SBBC arising from the proposer’s negligence. United expressly agreed to Section 10.19, but stated that it would not indemnify clients for the acts of network providers. The statement does not conflict with the provisions for indemnifying SBBC and clarifies any mistaken inference that United was assuming responsibility for the acts of third persons over whom United lacked control. Similarly, Subsection 10.31.2 of the RFP set forth a proposer’s obligations to indemnify SBBC and Subsection 10.31.1 set forth SBBC’s obligation to indemnify a proposer. United’s response to the subsectioins did not refute its obligations to indemnify SBBC, but simply reiterated its prior statement regarding an inability to indemnify enrollees for the acts of network providers over whom United lacked control. Subsection 10.41(a) of the RFP provided that no rate increase could occur until the end of any applicable rate guarantee period. Consistent with Section 9.4 which provided that any term or condition may be negotiated by the Insurance Committee with the selected proposer(s), United responded in its proposal that these requirements will be discussed if United is considered a finalist. As discussed earlier, Section 10.42 of the RFP provided that "SBBC may negotiate performance standards and performance guarantees with selected proposer(s)." Attachment K of the RFP invited each proposer to review certain "proposed" performance standards and liquidated damages. United properly responded to Attachment K, stating that the performance guarantees had been endorsed by its executive leadership and acknowledged that the allocation of fees at risk would be mutually agreed upon if United were selected as a finalist. Section 10.8 of the RFP addressed liquidated damages for non-conforming services and the filing of actions in Broward County courts. Consistent with Section 10.42’s provision for the negotiation of performance standards and guarantees, United agreed to negotiate the issue of damages. In addition, United suggested use of alternative dispute resolution by the parties. Evaluation and Scoring of Proposals The ultimate decision to issue the RFP and award contracts was made by SBBC. SBBC’s Superintendent maintains a standing committee known as the Insurance Committee which provides advice and input to the Superintendent regarding insurance issues, including the development of an RFP as well as the review and scoring of the proposals which are submitted in response to the RFP. The Insurance Committee makes recommendations to the Superintendent who, in turn, makes recommendations to SBBC. Section 9.1 of the RFP at issue was entitled "Evaluation of Proposals" and set forth the following process and criteria for the scoring of the proposals: The Superintendent’s Insurance Advisory Committee (hereinafter referred to as "Committee") shall evaluate all proposals received, which meet Section 7.0 Minimum Eligibility Requirements, according to the following criteria: CATEGORY MAXIMUM POINTS Experience and Qualifications 30 Scope of Services Provided 30 Minority/Women Business 10 Participation Cost of Services Provided 30 TOTAL 100 Additional points were awarded to proposers who quoted all three delivery models pursuant to Article 2. SBBC retained an independent consulting firm ("Consultant") to assist in the development of the RFP and the review and evaluation of the proposals. In addition to the Consultant, staff including SBBC’s Director of Benefits, Director of Risk Management, Director of Purchasing, M/WBE Compliance Director and legal counsel served as technical resources for the Insurance Committee at each meeting. The Insurance Committee met at least eight times and in excess of 39 hours to analyze, evaluate, score, and recommend an awardee from the proposals. All meetings were recorded and transcribed by a court reporter and entered into this record. Copies of the RFP, Addendum No. 1 and of the various proposals were provided and available at each Insurance Committee meeting. The Consultant prepared a voluminous document entitled "Analysis of Proposals" which was divided into sections corresponding to each of the health care delivery products submitted in the proposals. Each section provided a side-by-side comparison of each proposal submitted. Each section was further divided into subsections corresponding to experience and qualifications, scope of service and M/WBE that comprised the evaluation criteria categories other than cost. The Analysis of Proposals was provided and explained in detail to the Insurance Committee. The Consultant presented a document entitled "Listing of Proposal Deviations," which addressed the minimum eligibility criteria, scope of services, and other portions of the RFP. It provided a side-by-side comparison of each proposal and was thoroughly explained to the Insurance Committee. The Consultant also prepared a document entitled "Benefit Comparison," which provided a side-by-side analysis of the health care benefits submitted by each of the proposers and was thoroughly explained to the Insurance Committee. The Consultant prepared and presented an additional document entitled "Comparison of Existing Contract Costs and Proposed Costs by Plan Type" ("Cost Comparisons") which provided a side-by-side comparison by plan type along with cost and enrollment data for SBBC’s current benefits programs. Again, the Consultant hired an outside analyst to prepare a report regarding the financial stability of each proposer. It was presented and explained to the Insurance Committee on two occasions. Upon review of the proposals, the Insurance Committee immediately recommended rejection of the proposal submitted by UniPsych on the following grounds: Reject proposal from Unipsych Benefits of Florida. Proposer did not meet the Minimum Eligibility Criteria specified in Section 7.0. Additionally, proposer was deemed non- responsive to the requirements of this RFP for submitting a proposal for behavioral health care services only. On October 30, 2000, the Insurance Committee met and scored the proposals submitted by the proposers. The score sheets were structured to correspond to the evaluation criteria contained in the RFP. Three of the 11 members of the Insurance Committee testified at the formal hearing. Each stated that in scoring the proposals, he/she applied the evaluation criteria contained in the RFP to the materials submitted to him/her as a Committee Member for analysis of the proposals as well as the presentations made by the Consultant, technical staff, and proposers. The proposals of AvMed, Beacon, HIP, Humana, Maxon, and United were determined by the Insurance Committee to meet the RFP’s minimum eligibility requirements and each of these proposals was scored in accordance with the RFP. The scoring tabulation for the top four plans under each health care delivery model were as follows: HMO: Humana (Alternate Plan 1) 81.73 points; HIP (Match Current Plan) 79.82 points; AvMed (Match Current Plan) 75.63 points; United (Self-Insured Plan) 69.91 points; POS: Humana (Alternate Plan 1) 78.27 points; AvMed (Match Current Plan) 75.55 points, HIP (Alternative Plan 1) 75.27 points; HIP (Match Current Plan) 75.23 points; Modified PPO: United (Self-Insured Plan) 77.09 points; HIP (Match Current Plan) 76.56 points; Humana (Alternative Plan 1) 73.19 points; Maxon 60.45 points; PPO: Humana (Alternative Plan 1) 77.37 points; HIP (Match Current Plan) 77.00 points; United (Self-Insured Plan) 74.63 points; HIP (Alternative Plan 1) 73.83 points. Upon review of the scores for the 11 Insurance Committee Members, eight members scored Humana’s HMO (Alternative Plan 1) higher than AvMed’s HMO (Match Current Plan), nine members scored Humana’s HMO (Alternative Plan 1) higher than AvMed’s HMO (Alternate Plan 1), seven members scored Humana’s POS (Alternative Plan 1) higher than AvMed’s POS (Match Current Plan), and seven members scored Humana’s POS (Alternative Plan 1) higher than AvMed’s POS (Alternative Plan 1). Short-Listing , Negotiations and Recommendation After the proposals were scored pursuant to Section 9.1, the Insurance Committee was authorized to recommend award to the top-ranked proposer, to recommend award to more than one top- ranked proposer, to short-list the top-ranked proposers for further consideration or to reject all proposals received. After scoring the proposals, the Insurance Committee chose the top four proposed plans for each health care delivery product. After scoring the proposals, the Insurance Committee received a copy of a letter sent to the Superintendent by the chief executive officer of HIP. In this letter, HIP described three scenarios for the provision of medical benefits to SBBC employees in 2001 involving the continued provision of medical benefits by HIP under its existing contract with SBBC. The Insurance Committee determined it was impractical for each proposer’s representative to participate in post-scoring interviews and return for post-scoring negotiations. As such, the Insurance Committee voted to consolidate interviews and negotiations and provided each short-listed proposer, including AvMed, the opportunity to participate in interviews/negotiations with the Insurance Committee. Thereafter, each short-listed proposer was invited to attend a meeting of the Insurance Committee to negotiate and bind the proposer to contract terms. Humana negotiated a number of its terms with the Insurance Committee. AvMed was willing to negotiate the provision of a telephone service line within the local area code. Upon completion of the interviews/negotiations, the Insurance Committee voted to withhold the options of POS and modified PPO plans to employees due to minimal past enrollment interest. The Insurance Committee carefully considered at least four combinations of plans submitted in the proposals as well as eight combinations of plans submitted in the proposals with plans provided under HIP’s current contract. The Insurance Committee briefly considered combining AvMed’s HMO (Match Current Plan) with Humana’s Modified PPO (Alternative Plan 1); however, the terms of Humana’s proposal eliminated it from consideration in the proposed configuration. Another combination of plans discussed coupled AvMed’s HMO (Match Current Plan) with Humana’s HMO (Alternative Plan 1) and Humana’s PPO (Alternative Plan 1). The terms of Humana’s proposal eliminated it from consideration in the proposed configuration. The Insurance Committee also considered the combination of AvMed’s HMO with United’s PPO and the combination of Humana’s proposed HMO (Alternative Plan 1) and PPO (Alternative Plan 1) with the HMO and PPO plans provided by HIP under its current contract with SBBC. The individual Insurance Committee Members each ranked their top five combinations of plans. Their rankings were totaled and sent to the Superintendent of Schools as the Committee’s recommendation. Of the five combinations forwarded to the Superintendent, the Insurance Committee’s top-ranked combination of plans coupled Humana’s proposed HMO (Alternative Plan 1) and PPO (Alternative Plan 1) with the HMO and PPO plans provided by HIP under its current contract with SBBC. The fifth-ranked combination coupled AvMed’s proposed HMO (Match Current Plan) with United’s PPO product. Upon receipt and review of the recommendation, the Superintendent determined that SBBC’s collective bargaining agreements required that it continue to provide POS and Modified PPO plans to employees and directed the Insurance Committee to modify its recommendation to include them. The Insurance Committee reconvened and voted to add the POS and Modified PPO plans submitted by Humana to the combination previously recommended. Humana had the highest scored POS plan in the evaluation process and its Modified PPO was short-listed for consideration. AvMed did not propose a Modified PPO product under the RFP. The revised recommendation which included the POS and Modified PPO products was forwarded to and accepted by the Superintendent. He posted the recommendations/tabulations dated November 6, 2000, and recommended to SBBC that it award a contract to Humana for its HMO (Alternative Plan 1), POS (Alternative Plan 1), Modified PPO (Alternative Plan 1) and PPO (Alternative Plan 1) plans to be offered to SBBC employees along with the existing HMO, POS, Modified PPO and PPO plans under HIP’s current contract with SBBC. AvMed timely filed a Notice of Protest on November 9, 2000. The School Board awarded a contract to Humana under the RFP on November 9, 2000, declaring an immediate and serious danger to the public health, safety, or welfare pursuant to Section 120.57(3)(c), Florida Statutes, and on November 20, 2000, AvMed timely filed its Formal Written Protest.
Recommendation Based upon the foregoing Findings of fact and Conclusions of Law, it is RECOMMENDED that the School Board of Broward County, Florida enter a Final Order dismissing the Formal Written Protest filed by AvMed, Inc. d/b/a AvMed Health Plan. DONE AND ENTERED this 9th day of May, 2001, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER 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 May, 2001. COPIES FURNISHED: Andrew S. Berman, Esquire Young, Berman, Karpf & Gonzalez, P.A. 17071 West Dixie Highway North Miami Beach, Florida 33160 Joseph M. Goldstein, Esquire Shutts & Bowen, L.L.P. First Union Center 200 East Broward Boulevard, Suite 2000 Fort Lauderdale, Florida 33301 Edward J. Marko, Esquire Robert Paul Vignola, Esquire School Board of Broward County 600 Southeast Third Avenue, 11th Floor Fort Lauderdale, Florida 33301 Dr. Frank L. Till, Jr., Superintendent School Board of Broward County 600 Southeast Third Avenue, 11th Floor Fort Lauderdale, Florida 33301
The Issue Whether Petitioner's claim for medical expenses from August 6, 1982 through February 27, 1983 should be approved, pursuant to the State of Florida Employees Group Health Self Insurance Plan. Petitioner appeared at the hearing accompanied by legal counsel. The Hearing Officer thereupon explained his rights and procedures to be followed in the administrative hearing. Petitioner acknowledged that he understood his rights and elected to represent himself. Petitioner testified in his own behalf at the hearing and the parties stipulated to the introduction of Respondent's Exhibits 1 and 2. A late filed exhibit, Respondent's Exhibit 3, was also admitted in evidence. Respondent presented the testimony of one witness, William R. Seaton, Benefit Analyst for the Respondent's Bureau of Insurance.
Findings Of Fact Petitioner Thomas J. Appleyard, III, is a former state employee who retired with disability in 1976 as a result of cardiac disease. At the time Petitioner retired, he maintained coverage in the state Employees Group Health Self Insurance Plan under which the Blue Cross/Blue Shield of Florida, Inc. serves as the administrator of the plan for the state. Petitioner also receives disability benefits under the Medicare program for medical expenses. (Testimony of Petitioner) The State Group Health Self Insurance Plan provides in Section X, COORDINATION OF BENEFITS, that if an insured has coverage under Medicare, the benefits payable under the state plan will be coordinated with similar benefits paid under the other coverage to the extent that the combination of benefits will not exceed 100 percent of the costs of services and supplies to the insured. Paragraph D of Section X provides that the state plan will be the secondary coverage in such situations and will pay benefits only to the extent that an insured's existing insurance coverage does not entitle him to receive benefits equal to 100 percent of the allowable covered expenses. This provision applies when the claim is on any insured person covered by Medicare. (Testimony of Seaton, Respondent's Exhibit 3) Petitioner was hospitalized at the Tallahassee Memorial Regional Medical Center on three occasions in 1982-33. His Medicare coverage paid all but $261.75 of the hospital expenses. In February 1983, Petitioner also incurred medical expenses to his cardiologist, Dr. J. Galt Allee, in the amount of $248.33. Petitioner was originally denied his remaining hospital expenses by the administrator of the state plan under the erroneous belief that he was receiving regular Medicare benefits for persons over the age of 65. In addition, Dr. Allee's bill was only partially paid by Medicare, subject to the receipt of additional information from the physician. Payment under the state plan was limited to an amount sufficient to reimburse petitioner 100 percent of the amount originally allowed by Medicare. (Testimony of Seaton, petitioner, Respondent's Exhibit 1, 3) Respondent does not receive information on claims filed under the state plan until contacted by an employee. In February 1984, Petitioner requested assistance from William R. Seaton, Benefit Analyst, of Respondent's Bureau of Insurance, regarding his difficulties in receiving proper claims payments. Seaton investigated the matter with the Insurance administrator for the state, Blue Cross/Blue Shield of Florida, and discovered that the latter had not coordinated the hospital expense balance with Medicare. They thereafter did so and as of the date of hearing, there was no longer a balance due to Tallahassee Memorial Regional Medical Center. Seaton also gave written instructions to Blue Cross to review all of Petitioner's claims and make sure that they were paid properly, and to install controls on his and his wife's records. (Testimony of Petitioner, Seaton, Respondent's Exhibit 1-2) The full claim of Dr. Allee had not been paid by Medicare since it had been awaiting requested additional in formation from the physician. Such information was provided after a personal visit had been made to Dr. Allee by Seaton and Medicare then recognized additional eligible expenses. However, a balance of $36.00 is still owed to the physician due to the fact that Blue Cross/Blue Shield had not received the necessary payment information from Medicare as of the day before the hearing. (Testimony of Seaton, Respondent's Exhibit 1) Section XVII of the state's Group Health Self Insurance Plan benefit document provides that an employee who wishes to contest decisions of the state administrator considering the employee's coverage under the plan may submit a petition for a hearing for consideration by the Secretary of Administration. (Respondent's Exhibit 3)
The Issue Does the Prescription Drug Services Plan administered by the Division of State Group Insurance provide coverage for the drug Xenical as prescribed to the Petitioner?
Findings Of Fact The Plan The Division of State Group Insurance is authorized to provide health insurance coverage to employees of the State of Florida through a fully insured plan or a self-insured plan. The decision to offer a self-insured plan is explained in the State of Florida Employees Group Health Self Insurance Plan Booklet and Benefits Document (the "Plan Booklet and Benefits Document"): As is the case with many major employers, the State of Florida determined that a self- insured plan would result in significant savings to the participating members, and, therefore, implemented the current self- insured program in 1978. Being self-insured means that Claims are paid directly from funds belonging to the State of Florida, with the State earning interest on all fund balances. In addition, the Plan avoids charges normally charged by insurance companies such as retentions, reinsurance, risk factors, and other insurance related charges. (Petitioner's Ex. 7, p. 2.) Denominated the State of Florida Employees' Group Health Insurance Plan, the Plan has both a Servicing Agent and a Prescription Drug Program Administrator. At the time the events leading to this case arose, the Servicing Agent was Blue Cross/ Blue Shield of Florida, Inc., and the Prescription Drug Program Administrator was Eckerd Health Services ("EHS"). By designation of the Florida Legislature, however, the Division is responsible for the administration of the Plan. In the capacity of Plan Administrator, "the Division . . . has full and final decision-making authority concerning eligibility, coverage, benefits, claims, or interpretation of the Benefit Document." (Id.) Mr. Magee, Diabetes and Hypercholesteremia Dennis J. Magee is an employee of the Department of Corrections. He has been covered by State Health Insurance since he commenced his employment with the state in 1971. Mr. Magee has participated in numerous health insurance plans over the course of his employment. For the past three or four years, at least, he has participated in the State of Florida Group Health Self-Insurance Plan administered by the Division. Approximately twelve years ago, Mr. Magee was diagnosed with diabetes. Since the initial diagnosis, his diabetes mellitus type 2 has become complicated by microangiopathy, nephropathy, retinopathy, hypercholesterolemia (elevated serum cholesterol) and obesity. With regard to obesity, Mr. Magee was determined near the time of hearing to have a body mass index of 32.25, an index beyond the threshold for obesity. Dr. Croom and Xenical Mr. Magee's physician is William P. Croom, M.D. Dr. Croom is an endocrinologist specializing in the treatment of types 1 and 2 diabetes mellitus. On July 22, 1999, Dr. Croom prescribed Xenical, a drug used in the control of obesity, at a dosage of 150 milligrams for Mr. Magee. The prescription was medically necessary in Dr. Croom's view because Mr. Magee "has been unsuccessful in managing his obesity with diet and exercise" (Petitioner's Ex. 2) and because "his diabetes and hyperlipidemia [elevated cholesterol] are driven by his obesity . . . ." (Petitioner's Ex. 3). Attempt to Fill the Prescription Mr. Magee presented the prescription to Express Pharmacy Services. It was not honored. On August 3, 1999, Express Pharmacy Services wrote to Mr. Magee that "[t]his item is not covered by your insurance. Please contact your benefits rep. if you have questions." Petitioner's Ex. 4. Appeal to the Division Eckerd Health Services, the Prescription Drug Program Administrator, affirmed the denial of the prescription. Mr. Magee appealed the decision to the Division. The Department of Management Services has an appeals committee, which reviews all denials of coverage by EHS. The appeals committee is composed of three members within the Division: the director, the assistant director and the Policy and Development Bureau Chief. The Director, at the time Mr. Magee's appeal was considered, Mr. Slavin, is a diabetic. The appeals committee looked into Xenical as a treatment for diabetes. It obtained information through literature and internet research and from consultation with physicians at Blue Cross/Blue Shield. On the basis of the research, the committee concluded that Xenical is used only for the treatment of obesity and not for the treatment of diabetes. The appeal resulted in the letter from Director Slavin (referenced in the Preliminary Statement of this order) in which the Director wrote, "I am writing in response to your appeal of the decision by Eckerd Health Services (EHS) to deny coverage for Xenical [and] [r]egrettably, we must concur with EHS' determination." The Plan Booklet and Benefits Document Basis for the Denial The Division's concurrence with EHS that coverage for Xenical should be denied was based on the Prescription Drug Program Section of the Plan Booklet and Benefits Document. The program is described in Part XXVIII, Section W. Subsection 1., Covered Drugs, on p. 57 lists "(a) [f]ederal legend drugs" and "(b) [s]tate restricted drugs" as among those drugs covered. Among the list under Subsection 5., entitled "Exclusions," however, is "(c) [a]nti-obesity drugs." The listing of anti- obesity drugs under Part XXVIII, Section W., Subsection 5, the "Exclusions" subsection, ultimately, is the basis for the Division's denial of coverage of Xenical as prescribed for Mr. Magee. The Plan Booklet and Benefits Document is prepared on an annual basis by the Division. Typically, the Plan Booklet and Benefits Document is "enacted by the Legislature every year through the appropriation[] process of Section 8 of the Appropriations Act." (Tr. 54). For example, the Conference Report on Senate Bill 2500, General Appropriations for 1999- 2000, under Specific Appropriation states: 9) All State Group Health Insurance Plan benefits as provided in the State of Florida Employees Group Health Insurance Plan Booklet and Benefit Document effective January 1, 1998, . . . shall remain in effect. Changes to the benefits provided by the Plan Booklet and Benefits Document are normally initiated by submission of the Governor in his Legislative Budget Request. Benefit changes must be approved by the Legislature. The Plan Booklet and Benefit Document provides, among many, the following definitions: "Covered Services and Supplies" shall mean those health care services, treatments, therapies, devices, procedures, techniques, equipment, supplies, products, remedies, vaccines, biological products, drugs, pharmaceutical and chemical compounds which expenses are covered under the terms of the Benefit Document. The Administrator has final authority to determine if a service or supply is covered or limited by the Plan. * * * "Medical Supplies or Equipment" means supplies or equipment that must be: ordered by a Physician; of no further use when medical need ends; usable only by the Participant patient; not primarily for the Participant patient's comfort or hygiene; not for environmental control; not for exercise; manufactured specifically for medical use. (Petitioner's Ex. 7, Definitions 21 and 50, pgs. 17 and 23, respectively.) Drugs are services as defined by the Plan Booklet and Benefits Documents. But drugs that are excluded from coverage, such as anti-obesity drugs, are not "covered services" as defined by the Plan Booklet and Benefits Document since by definition, an exclusion prevents them from being "covered." As a "service," moreover, Xenical is not covered by virtue of Section G. of the Benefits Document, also entitled "Exclusions." Petitioner's Ex. 7., p. 38. With regard to services "related to obesity and weight reduction," the Benefits Document states the following: G. EXCLUSIONS The following are not Covered Services and Supplies under the Plan. * * * All services and supplies related to obesity or weight reduction except: Medically Necessary intestinal or stomach by-pass surgery; or medically related services provided as part of a weight loss program when weight loss of a Participant is required by the surgeon prior to performing a Medically Necessary surgical procedure. (Petitioner's Ex. 7, pgs. 38, 41.) Xenical and Section 627.65745, Florida Statutes Subsection 627.65745(1), Florida Statutes, states: A health insurance policy or group health insurance policy sold in this state, including a health benefit plan issued pursuant to 727.6699, must provide coverage for all medically appropriate and necessary equipment, supplies and diabetes outpatient self management training and educational services used to treat diabetes, if the patient's treating physician or a physician who specializes in the treatment of diabetes certifies such services are necessary. Xenical, a drug, is obviously not "equipment." Nor would it fall under the category of "self management training and educational services used to treat diabetes." It does not fall under the category of "supplies" either. Under the coding system developed by the Health Care Financing Administration of the United States Department of Health and Human Services, the standard coding system for the payment of health claims, drugs are not supplies. Examples of supplies include prosthetics, testing supplies, artificial limbs, ventilators, needles, and insulin pumps. Update of the Basis for the Prescription In a letter dated June 13, 2000, Dr. Croom more fully explained the basis for the prescription. Xenical is medically necessary for the treatment of diabetes and is not for cosmetic purposes. Xenical is a part of Mr. Magee's outpatient management program which consists of other medications and education. Despite these medications, his most recent hemoglobin A1C is 9.1 significantly higher than the recommended target of 7.0. The use of Xenical would be instrumental in reducing this parameter. In my opinion, Xenical is medically appropriate and necessary. (Petitioner's Ex. 3). The appeals committee did not have the benefit of Dr. Croom's June 13, 2000, letter in which Dr. Croom opined that in the case of Mr. Magee, "Xenical is medically necessary for the treatment of diabetes and is not being used for cosmetic purposes." Other Purpose for the Prescription That a drug's effectiveness is primarily for the treatment of an excluded purpose may not necessarily exclude it from coverage if it were prescribed for some other purpose. This point was elicited during testimony of the Division's witness, C. Merrill Moody, the Division's Assistant Director: (Tr. 81). MR. MOODY: If [Xenical] was being prescribed for obesity, it would be excluded; if it was not, it would not. And I'll give you an example. We have a direct exclusion for contraceptives for contraceptive use . . . [b]ut contraceptives can be used for other purposes. . . . [P]articipants are required to provide us with a letter from the doctor describing what the contraceptive is being used for. We then cover that contraceptive. Mr. Moody went on to explain that oral contraceptives, because of certain properties, are used also in the management of conditions not related to prevention of contraception. For example, oral contraceptives are prescribed in the treatment of menopause because of their ability to maintain the levels of certain hormones. If prescribed for that purpose, then, despite the fact that they are oral contraceptives and normally excluded from coverage, they are covered because of the non-contraceptive basis for the prescription. The Division's position with regard to oral contraceptives is consistent with the exclusion contained in Section W.5. of the Plan Booklet and Benefits Document. There the "Exclusions List" states "(a) Oral contraceptives for contraception." Petitioner's Ex. 6, p. 59. In other words, it is not some policy of the Division that provides coverage for oral contraceptives when the prescription is for a purpose other than contraception. The coverage is provided by the Plan Booklet and Benefits Document, itself. If oral contraceptives are prescribed "for contraception" then they are excluded from coverage. If prescribed for some other medical purpose, then the exclusion contained in Section W, 5(a) does not prevent coverage of oral contraceptives.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that: the Division of State Group Insurance in the Department of Management Services enter a final order denying coverage of Dennis J. Magee's prescription for Xenical; and, the Division present to the Legislature the Plan Booklet and Benefits Document amended so as to allow coverage of anti-obesity drugs for diabetics if such drugs are prescribed as medically necessary for management of the subscriber's diabetes. DONE AND ENTERED this 28th day of July, 2000, in Tallahassee, Leon County, Florida. DAVID M. MALONEY 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 28th day of July, 2000. COPIES FURNISHED: Dennis J. Magee Post Office Box 636 Safety Harbor, Florida 34695 Cindy Horne, Esquire Department of Management Services 4050 Esplanade Way, Suite 260 Tallahassee, Florida 32399-0950 Thomas D. McGurk, Secretary Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950 J. Bruce Hoffmann, General Counsel Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950
Findings Of Fact Petitioner resigned from State Government on July 23, 1987. At the time of his resignation, Petitioner was covered under the Florida State Group Health Insurance Plan. His wife, who is a diabetic, was also covered under Petitioner's insurance. Upon termination Petitioner was eligible for continuation of coverage benefits under the federal COBRA Act. However, prior to receiving any notice of his COBRA rights, Petitioner elected to continue his State Employees' Insurance for two months from July 1, 1987 and then begin coverage under his new employer's insurance plan. 2/ Petitioner made advance payment on the 2 months additional coverage. The payments carried his State Employees' health insurance through September 1, 1987 when it was terminated. DOA notified Petitioner on August 27, 1987, of his right to elect continuation of coverage under the COBRA Act. This notice complied with the notice requirements under the COBRA Act. COBRA provides continued health insurance coverage for up to (18) months, after a covered employee leaves employment. However, coverage does not continue beyond the time the employee is covered under another group health plan. COBRA simply fills the gap between two different employers group health insurance plans so that an employee's group health insurance does not lapse while the employee changes jobs. Petitioner's new employer's health coverage began around September 1, 1987. After Petitioner had begun coverage under his new insurance plan, he discovered that his wife's preexisting diabetic condition would not be covered. However, no evidence was presented that Petitioner, within 60 days of September 1, 1987 requested the Division of State Employee's Insurance to continue his insurance coverage pursuant to COBRA. Moreover, Petitioner's COBRA rights terminated when he began his coverage under his new employer's health plan.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Administration enter a Final Order denying Petitioner's request for continuation of coverage under COBRA. DONE and ENTERED this 5th day of April, 1989, in Tallahassee, Florida. DIANE CLEAVINGER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of April, 1989.
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.
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
Recommendation 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.
The Issue The issue in this case is whether the Respondent, the Department of Administration, Division of State Employees' Insurance, administrator of the State of Florida group health insurance policy, should pay all covered medical expenses incurred by the Petitioners for non-PPC providers on behalf of their dependent daughter that exceed $3,000 1/ maximum out-of-pocket expense stop loss provision of the policy, despite the part of the stop loss provision that subjects it to maximum payments for room and board (and some other services) supplied by non-PPC providers.
Findings Of Fact Pertinent History of the Insurance Plan. The State of Florida offers group health insurance to its employees, including employees of the State University System, as an optional fringe benefit. Since 1978, the State has self-insured this coverage. The group health insurance coverage is administered by the Respondent, the Department of Administration, Division of State Employees' Insurance. The Respondent contracts with Blue Cross Blue Shield of Florida as a third party administrator of the insurance coverage. The State pays part of the premium required for the coverage; the balance of the premium is paid by the employee. Depending on their county of residence, state employees can choose membership in one of several approved health maintenance organizations (HMOs) in lieu of coverage under the State's health insurance plan. When an employee joins an approved health maintenance organization in lieu of the state health insurance plan, the State contributes to the cost of membership to the same extent that it contributes to an employee's insurance premium under its group health insurance plan. Since the State began to self-insure in 1978, coverage under the state group health insurance contained limits on the maximum amount the plan would pay for hospital room and board. The plan also differentiated between the amounts that would be paid under the plan for services rendered by pre-approved "preferred providers" (PPCs). From time to time through the years, the Florida Legislature changed the maximum amounts the plan would pay for various services, and the plan was changed accordingly. But in each version of the plan, there was a distinction made between services rendered by a PPC versus services rendered by a non-PPC. When the State began to self-insure its employee group health insurance benefit on May 1, 1978, it mailed a new, 25-page certificate of insurance to each employee covered by the plan. Whenever a change in the coverage under the state group health insurance plan was occasioned by new legislation, a revised certificate of insurance was mailed to each employee covered by the plan. This occurred in July, 1982, (a 40-page booklet), in August, 1983, (an eight-page addendum), in August, 1985, (a 13-page booklet), and in July, 1988 (a 13-page booklet). Consistent with the master group health insurance policy to which they refer, each of these certificates of insurance are clear that the maximum out- of-pocket "stop loss" feature is subject to certain limitations. In particular, all make clear that the feature is subject to a maximum payment for room and board. Each of these certificates of insurance contains language cautioning the employee that the certificate is not a contract of insurance, that the purpose of the certificate is only to summarize the insurance plan, and that the certificate does not include all covered and non-covered benefits. Each also advises that a copy of the complete contract (the master policy), and the administrative rules under which the plan is administered, could be inspected in the office of the Respondent, as well as in the employee's personnel office. Each advises employees to present questions to their agency personel office or to the Office of State Employee's Insurance. The August, 1985, certificate of insurance reflects a change in the policy to differentiate between PPC and non-PPC providers. It also clearly states that the maximum out-of-pocket stop loss feature of the policy is subject to maximum payments for room and board (and some other services) supplied by non-PPC providers. The July, 1988, certificate also clearly provides that the maximum out-of-pocket stop loss feature of the policy is subject to maximum payments for room and board (and some other services) supplied by non-PPC providers. Both of these certificates were entitled the "State of Florida Employees Group Health Self Insurance Plan Brochure." In addition to the certificates of insurance, Blue Cross Blue Shield also printed an abbreviated version of the July, 1988, insurance certificate called the "State of Florida Employees Group Health Self Insurance Plan Benefits." It is a seven-page document intended for distribution, along with information concerning the various available state-approved HMOs, to all new state employees, who have the opportunity to choose to enroll in the state group health plan, in one of the HMOs, or neither. It also was intended for distribution to all employees during open enrollment periods, when employees have the opportunity to change from an HMO to the state group health insurance, or vice versa, or to drop the benefit. The purpose of the "benefits" document was to give employees information on which to make that choice. Since it was anticipated that it would be mailed to many state employees who ultimately would choose against the state group health insurance plan, the information was condensed to shorten the document to save mailing costs. Only if a new employee (or an old employee during the open enrollment period) chose the insurance would the employee get mailed a certificate of insurance in the mail. Among the information contained in the July, 1988, "benefits" document was an item entitled "Maximum Out of Pocket Expense" that simply listed: "$1500 individual coverage" and "$3000 family coverage." Omitted from the "benefits" document were the limitations on the maximum out-of-pocket stop loss feature (Finding 7, above) and the language cautioning that it was not a contract (Finding 6, above). Under the heading "Exclusions and Limitations," it states: "Complete list in employee brochure." The last two pages of the document contains two lists, one entitled "Limitations," and the other entitled "Exclusions." Neither list specifies the limitations on the maximum out-of- pocket stop loss feature (Finding 7, above). On the cover of the document, it states: "This brochure replaces any other brochure or booklet printed prior to July 1, 1988, relative to the Plan and shall remain in effect until further notice." The Saffs' Insurance Decision. Edward B. Saff has been a mathematics professor at the University of South Florida (USF) in Tampa, Florida, for 22 years. The Saffs did not prove that they did not receive copies of the May 1978, July, 1982, August, 1983, August, 1985, and July, 1988, certificates of insurance. The Saffs' daughter Lisa, who was born on April 24, 1970, had been diagnosed in June, 1985, as having acute lymphoblastic leukemia. She was treated at the University of South Florida through June, 1988, and seemed to have been cured. During the summer of 1988, the Saffs had occasion to consider the question whether they should obtain health insurance other than, and in addition to, their family coverage under the State employees' group health insurance. Although the Saffs did not prove that they had not received their copies of the May 1978, July, 1982, August, 1983, August, 1985, and July, 1988, certificates of insurance, they apparently did not retain them or at least did not have them readily available to consult. As a result, Dr. Saff asked his secretary to get information on the state employees' group health insurance coverage from the USF personnel office. The evidence was that the Department of Administration has made a copy of the master group health self-insurance policy, and copies of the certificate of insurance, available in all state agency personnel offices, including in the USF personnel offices, for inspection by state employees. The July, 1988, certificate of insurance states: "The agency personnel office will provide needed assistance to State officers and employees enrolling in the Plan; however, such officers or employees should take care to assure that they receive the coverage applied for and that proper deductions are made." But there was no evidence specifically what Dr. Saff told his secretary to ask of his USF personnel office. Dr. Saff's secretary did not testify, and there was no evidence from which a finding can be made as to what the secretary asked for or what the secretary was told by the USF personnel office. But the secretary returned with a copy of the abbreviated version of the July, 1988, insurance certificate (the "State of Florida Employees Group Health Self Insurance Plan Benefits.") Cf. Findings 8 and 9, above. Based exclusively on the information relayed by Dr. Saff's secretary, i.e., on the abbreviated version of the July, 1988, insurance certificate (the "State of Florida Employees Group Health Self Insurance Plan Benefits"), with its incomplete information under the heading entitled "Maximum Out of Pocket Expense," the Saffs decided that they did not need any additional health insurance coverage for their daughter Lisa. They reasoned that they could afford the maximum out of pocket expense referenced in the document. They did not seek any further information about the policy before making this decision. The Saffs' Insurance Claim. In August, 1990, Lisa Saff underwent a routine gynecological examination, and a pelvic mass was discovered. The mass was removed surgically at Humana Women's Hospital in Tampa. Cancer of the ovaries was diagnosed, but at first the type of cancer was not identified. After more tests, it was determined that Lisa had suffered a recurrence of her previous cancer, but it was highly unusual for that type of cancer to recur in the ovaries. Since the physicians at Humana Women's and at USF were unfamiliar with the recurrence of the cancer in the ovaries, they recommended that Saffs seek medical care at Sloan-Kettering Hospital in New York City, where Lisa began treatment in the early part of September, 1990. Since starting treatment at Sloan-Kettering, Lisa has been under the care of Dr. Timothy Gee. She was hospitalized at Sloan-Kettering three times in 1990 and approximately twice in 1991. Fortunately, she has responded to treatment and is now on the maintenance portion of her protocol, receiving treatment as an outpatient of the hospital. Sloan-Kettering charges $700 a day for a hospital room and also charges for some other medical services in excess of the PPC fee and charge schedule under the State of Florida Group Health Self Insurance policy. In all, the Saffs have incurred $46,870 for medical treatment for Lisa for 1990. As of the date of the final hearing, they incurred $14,439 for medical treatment for Lisa for 1991. They continue to incur medical expenses for Lisa under her maintenance protocol. They have submitted claims for payment under the state group health insurance policy, including all medical expenses during both 1990 and 1991 by which their out-of-pocket expense exceeded $3000 per calendar year. 2/ The Respondent's Position. In response to the Saffs' claims, the Respondent has taken the position that, in accordance with the master policy and the certificate of insurance, the maximum out-of-pocket stop loss feature of the policy is subject to maximum payments for room and board (and some other services) supplied by non-PPC providers. Cf. Finding 7, above. In accordance with that position, the Respondent has paid $18,554 of the Saffs' 1990 claims and $2,162 of the Saffs' 1991 claims. (The Saffs have paid $14,089 of the balance of their 1990 claims and $9,250 of the balance of their 1991 claims.)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Respondent, the Department of Administration, Division of State Employees' Insurance, enter a final order (1) giving effect to the provision of the group health self-insurance plan that subjects the maximum out- of-pocket stop loss feature of the policy to maximum payments for room and board (and some other services) supplied by non-PPC providers and (2) paying $18,554 of the Saffs' 1990 claims and $2,162 of the Saffs' 1991 claims. RECOMMENDED this 19th day of September, 1991, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of September, 1991.
The Issue The ultimate issue in this case is whether Respondent's proposed Florida Administrative Code Rule 69O-149.022(3), which would incorporate by reference Form OIR-B2-2112, constitutes an invalid exercise of delegated legislative authority. Before that issue may be reached, however, it is necessary to determine whether Petitioners have standing to challenge the proposed rule.
Findings Of Fact The Financial Services Commission ("Commission") is a four-member collegial body consisting of the governor and cabinet. The Office of Insurance Regulation ("Office") is a structural unit of the Commission. Giving rise to this case, the Office initiated rulemaking and made recommendations to the Commission concerning an amendment to rule 69O-149.022, which would incorporate by reference Form OIR-B2-2112, titled "Consumer Notice [Regarding] The Impact of Federal Health Care Reform on Health Plan Costs" ("Form 2112"). Whenever the Commission or the Office engages in rulemaking, the members of the Commission serve as the agency head. The Commission thus has the ultimate responsibility for approving and adopting the proposed rule. CHAIN is a nonprofit corporation which operates solely within the state of Florida. CHAIN is subject to the oversight of a voluntary board of directors. As a health-care advocacy organization, CHAIN is exempt from taxation under section 501(c)(3) of the Internal Revenue Code and derives its income primarily from grants and contributions. CHAIN provides services to low- and moderate-income individuals who lack health insurance coverage or perceive their coverage to be unaffordable or inadequate. CHAIN provides health insurance purchased through Florida's small-group health insurance market to each of its five full-time employees. Greg Mellowe is a full-time employee of CHAIN who receives health insurance coverage through such employment. During the 2013 regular session, the Florida Legislature passed a bill, which the governor approved, enacting section 627.410(9), Florida Statutes. This section requires that insurers provide to policyholders of individual and small-group nongrandfathered plans a notice that describes the estimated impact of the federal Patient Protection and Affordable Care Act ("PPACA")——popularly and more commonly known as Obamacare——on monthly premiums.1/ An insurer that issues a nongrandfathered plan must give this notice one time——when the policy is issued or renewed on or after January 1, 2014——on a form established by rule of the Commission. (A "nongrandfathered" plan is a health insurance plan that must comply with all of Obamacare's requirements. For ease of reference, such plans will be referred to as "compliant plans.") Having been directed to act, the Office commenced rulemaking to establish the form of the notice to be sent to persons insured under compliant, individual and small-group plans, eventually proposing to adopt Form 2112. The Commission approved this form at a hearing on August 6, 2013. Form 2112 fills a single, one-sided page2/ and looks like this: CHAIN will receive the Obamacare notice when it renews its small-group health insurance plan, or purchases a new plan, on or after January 1, 2014.
The Issue Whether the State of Florida through its Employees Group Health Self Insurance Plan is responsible for paying medical expenses incurred by Petitioner's newborn child where Petitioner had only individual coverage in effect at the time of that child's birth?
Findings Of Fact The State of Florida makes available to its employees several group insurance programs. In the area of health insurance, employees may choose to participate in the State of Florida Employees Group Health Self Insurance Plan, or they may enroll in a number of different HMOs depending upon the county in which each employee resides. The State of Florida Employees Group Health Self Insurance Plan (hereinafter "the Plan") is a plan of self insurance established by the State, specifically described in a Benefit Document, and administered by Blue Cross/Blue Shield. In addition to the provisions of the Plan embodied in the Benefit Document, the self insurance plan is regulated by those rules contained in Chapter 22K, Florida Administrative Code. If an employee voluntarily chooses to participate in the Plan, the State as the employer contributes to the employee's costs by paying a portion of the premium for each employee. HMOs wishing to capture a portion of the State employee insurance market may participate in bidding procedures whereby the winner(s) can offer insurance to State employees in particular geographical locations. Winning HMOs must comply with many of the rules and provisions involved in the Plan but are still able to establish additional benefits and requirements for coverage. If an employee voluntarily chooses to participate in an HMO insurance program, the State will assist with the employee's costs by contributing to that employee's insurance premium expense. At the time that they commence employment with the State, employees may elect to participate in the Plan, in one of the HMOs approved for that particular geographical location, or may choose to not participate in any of the voluntary insurance programs offered through the State. Thereafter, employees may only join one of the insurance programs or switch between programs during an annual open enrollment period. An employee may purchase individual coverage, insuring only himself or herself, or an employee may purchase family coverage, insuring that employee and one or more of his or her eligible dependents. During an open enrollment period, an employee may switch between individual coverage and family coverage for the following year. Under the State Plan, there is an exception to the restriction that employees may only change coverage and health plans during the open enrollment period. An employee having individual coverage may change to family coverage within 31 days after the date of acquisition of any eligible dependent. In that event, coverage for the eligible dependent does not relate back to the date of acquisition but rather will commence on some future date following the payment of the additional premium required for the additional family coverage. Similarly, an employee with only individual coverage may begin family coverage prior to acquiring eligible dependents and may obtain coverage for those dependents effective on the actual date the dependent is acquired by making application in time for a complete month's premium to be deducted prior to the first day of the month during which the dependent(s) will be acquired. In other words, payment must be made prior to the acquisition of an eligible dependent and the change to family coverage with its increased premium must be made prior to the acquisition of the dependent in order that coverage can be effective as of the date of acquisition. During open enrollment periods, all employees (even those not currently participating in any of the insurance programs offered by the State) are given summary information regarding the various programs in which they are being given an opportunity to participate. Brochures giving summarized comparisons of the Plan and the relevant HMOs are provided to all employees. Employees are advised, if they have questions regarding the Plan, to contact their personnel officer or the Division of State Employees' Insurance. After the employee makes a selection as to which health plan he or she wishes to participate in, if any, the employee will subsequently receive more detailed information about that plan. For example, an employee choosing to participate in the Plan will subsequently receive a copy of the State of Florida Employees Group Health Self Insurance Plan Brochure. The first page of that Brochure specifically advises the employee that the brochure does not include all of the provisions, definitions, benefits, exclusions, and limitations of the Plan. The Brochure specifically advises the employee that it is a summary of the benefits and that any questions the employee might have should be presented to the employee's agency personnel offices or the Office of State Employees' Insurance, and provides that latter office's address and telephone numbers. The Plan itself is a lengthy document which is not distributed to each individual employee but rather is made available to each agency's personnel office for reference by any interested employee. Under the Plan, a woman with individual coverage is entitled to maternity or pregnancy benefits. As part of those benefits, charges for "well baby care," i.e., the charges for the nursery for the baby, are covered under the Plan as part of the maternity benefit of the mother. In well-baby care, charges are not incurred by the baby as a separate patient. On the other hand, if a baby is ill and is admitted to the hospital as a patient in its own right, well-baby care coverage does not apply, and family coverage must be in effect or the infant will be an uninsured individual under the State Plan. The Dade County Public Defender's Office has approximately 265 employees. Faith Quincoses, an Administrative Assistant in that office, began her employment there in 1981 when the office had approximately 165 employees. As the number of office personnel increased, it was determined that someone within that Office should be responsible for employee benefits. That assignment was given to Quincoses, who at the time had duties related to payroll. Quincoses had no training in employee benefits, particularly employee insurance benefits, prior to her assuming responsibility for those duties at the Dade County Public Defender's Office. After she assumed those duties, the Public Defender's Office provided her with no training, and that office did not send her to any of the training sessions regularly conducted by Respondent for employees with and without personnel duties, including those seminars related to employee insurance benefits. When Quincoses would receive informational brochures and memoranda from Respondent regarding employee insurance benefits, she would read them but intentionally did not study them. She did not believe it was her responsibility to assist employees in selecting a particular insurance plan, or in advising employees as to which plan best met that employee's needs, or in answering any specific questions regarding coverage that any employee may have other than routine questions. Although many, if not most, of the informational brochures received from time to time by Quincoses advised employees (including Quincoses) to contact the Division of State Employees' Insurance with any questions regarding benefits and coverage, Quincoses did not contact that office when she had questions about the several insurance plans offered by the State to its employees. She very seldom contacted the Division of State Employees' Insurance to ask questions; rather, she discussed insurance benefits and coverage questions on an almost daily basis with a payroll clerk who worked for the Justice Administrative Commission, an agency belonging to the judicial branch of government with no responsibility or authority for administering the various insurance programs for state employees. Although Quincoses knew that she did not posses a copy of the State of Florida Employees Group Health Self Insurance Plan and had never read a copy, she made no effort to obtain a copy other than to once request a copy from the payroll clerk she daily contacted at the Justice Administrative Commission. When told by that payroll person that she did not have a copy of the Plan, Quincoses made no further efforts to obtain a copy and never requested a copy from the Division of State Employees' Insurance. Quincoses knew she was not an insurance expert and did not feel the need to become one. She believed that her responsibilities regarding the various insurance programs made available to employees by the State of Florida was to simply disseminate information provided to her, fill out the appropriate forms for payroll deductions, answer routine questions, and refer specific questions to the Division of State Employees' Insurance. She rightfully believed that each employee's decision as to which of the individual plans that employee should select was the employee's responsibility. Petitioner Annemarie Harris is an attorney employed as an Assistant Public Defender by the Dade County Public Defender's Office since October, 1983. As a new employee, she chose to enroll in one of the group health insurance programs approved by the State. She chose to join an approved HMO plan rather than enroll in the State of Florida Employees Group Health Self Insurance Plan. Thereafter, and up through December of 1987, each year during the open enrollment period, Petitioner chose to participate in one of the approved HMOs rather than the State's Self Insurance Plan. In December of 1987, the contract between the HMO of which Petitioner was a member and the State of Florida was being terminated, and Petitioner therefore had the option of selecting to participate in one of the other group health insurance programs offered through the State of Florida. In December of 1987, Petitioner was three months pregnant. Her baby was due to be born approximately June 20, 1988. Petitioner was, therefore, very interested in the most extensive coverage which she could obtain for her maternity benefits. Petitioner advised Quincoses that her expected delivery date was June 20, 1988, and that she wished her newborn to be covered by the insurance policy to be selected by Petitioner. Quincoses advised Petitioner that the baby's expenses would be covered if Petitioner added the newborn baby to Petitioner's coverage within 31 days after the date the baby was born. Quincoses did not advise Petitioner that waiting until after the baby's birth would mean that the baby would not be an individual insured until after Petitioner had paid the premium in time for the baby to be added as an insured by the first day of a month subsequent to the baby's birth, since Quincoses did not understand that distinction. The information Quincoses gave Petitioner was wrong and is not contained in any of the written materials describing the Plan which had been transmitted by the State to Quincoses or Petitioner, and is contrary to the information contained in Chapter 22K, Florida Administrative Code. Petitioner then conducted her own investigation of which health plan she wished to choose by asking her friends that worked in the Public Defender's Office about their personal experiences. Further, as Petitioner testified at the final hearing in this cause, Petitioner's husband strongly insisted that she choose the State's Self Insurance Plan in which Plan he had previously participated as a State employee and with which he therefore had some familiarity. Petitioner did not contact the Division of State Employees' Insurance regarding her specific questions and specific situation, did not consult the Benefit Document itself and did not--although both she and her husband are attorneys--consult the rules and regulations regarding coverage contained within Chapter 22K, Florida Administrative Code. Petitioner voluntarily selected the State's Self Insurance Plan and purchased only individual coverage, insuring herself at a lower premium than family coverage which would have covered the newborn infant as of the date of the baby's birth. It is unknown whether Petitioner relied solely on the advice of Quincoses in choosing to purchase individual coverage rather than family coverage, whether Petitioner relied instead on the advice she obtained from questioning her friends or whether she relied upon her husband's desires, in choosing to participate in the State Plan or in choosing to purchase only individual coverage. Although the basis for Petitioner's decision is unknown, her intentions at the time are clear. She planned to, and took steps to, initiate the paperwork necessary to switch to family coverage and pay the additional premium required early enough so that insurance for the baby would be in place on June 1, 1988, prior to the baby's expected arrival date. During April of 1988, Petitioner caused Quincoses to begin filling out the appropriate forms so that Petitioner would have family coverage in place as of June 1, 1988. Since Quincoses had earlier advised Petitioner that Petitioner could switch to family coverage after the baby's birth (which would make the baby's coverage effective subsequent to the baby's birth) but Petitioner chose instead to attempt to convert to family coverage prior to the baby's birth (which was contrary to Quincoses' advice and would have established coverage immediately upon the baby's birth), it can be reasonably inferred that Petitioner understood that the difference between converting to family coverage prior to the baby's birth rather than subsequent to the baby's birth involved the sole issue of the date on which the baby's coverage would become effective. Although Quincoses initiated the paperwork to have family coverage in place for Petitioner prior to the baby's birth expected to occur on June 20, 1988, Petitioner experienced complications with her pregnancy causing the baby to be delivered prematurely on April 24, 1988, prior to Petitioner signing and processing the paperwork started by Quincoses. Almost immediately after the baby's birth, the baby was transferred from the hospital in which her mother was a patient to another hospital where the baby was admitted as a separate patient. The baby remained in that hospital for some time, incurring medical expenses of approximately $180,000.00. Petitioner's medical expenses were paid by the Plan pursuant to her individual coverage. The baby's medical expenses were submitted to the Plan. Petitioner's claim for payment of the baby's medical expenses was denied for the reason that the baby was admitted to a different hospital than the mother as a separate patient but was not an insured under any insurance policy as of the date of the baby's birth, the date on which the baby commenced incurring her own personal medical expenses. When Petitioner converted her individual coverage to family coverage subsequent to the baby's birth, her claims for payment of the baby's medical expenses incurred subsequent to the date upon which the baby became an insured under the State Plan were denied since they arose from a condition pre-existing the date of commencement of insurance coverage. On April 24, 1988, Petitioner's newborn child was not an insured under the State Plan since Petitioner only had individual coverage on that date.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered denying Petitioner's claims for payment of medical expenses incurred by Petitioner's newborn baby which are the subject of this proceeding. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of October, 1989. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of October, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO 88-5519 Petitioner's proposed Findings of Fact numbered 1-4, 7-9, 15-18, 34, 35, 37, 38, and 40-42 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed Findings of Fact numbered 5, 6, 10-12, 21, and 33 have been rejected as not being supported by the weight of the credible evidence in this cause. Petitioner's proposed Findings of Fact numbered 13, 14, 39, 44, and 45 have been rejected as being subordinate to the issues for determination herein. Petitioner's proposed Findings of Fact numbered 19 and 22-25 have been rejected as not constituting findings of fact but rather as constituting recitation of the testimony, argument of counsel, or conclusions of law. Petitioner's proposed Findings of Fact numbered 20, 26-31, and 43 have been rejected as being irrelevant to the issues under consideration herein. Petitioner's proposed Finding of Fact numbered 32 has been rejected as being contrary to the weight of the totality of the evidence in this cause. Petitioner's proposed Finding of Fact numbered 36 has been rejected as being unnecessary for determination of the issues involved herein. Respondent's proposed Findings of Fact numbered 1-5, 7-18, the second 19-24, the first 27, the second 26, the second 27, and 28 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed Findings of Fact numbered 6, the first 19, 25, and the first 26 have been rejected as being subordinate to the issues required to be determined in this proceeding. COPIES FURNISHED: James N. Hurley, Esquire William P. Harris, Jr., Esquire Mitchell, Harris, Horr & Associates 2650 Biscayne Boulevard Miami, Florida 33137-4590 William A. Frieder, Esquire Department of Administration Office of the General Counsel 440 Carlton Building Tallahassee, Florida 32399-1550 A. J. McMullian, III Interim Secretary Department of Administration 435 Carlton Building Tallahassee, Florida 32399-1550 Augustus D. Aikens, Jr. General Counsel Department of Administration 435 Carlton Building Tallahassee, Florida 32399-1550 =================================================================
