The Issue Does Petitioner, AHF MCO of Florida, Inc., d/b/a PHC Florida HIV/AIDS Specialty Plan (Positive), have standing to contest the intended award to Simply for Regions 10 and 11 or to seek rejection of all proposals? (Case No. 18-3507 and 18-3508) Should the intended decision of Respondent, Agency for Health Care Administration (Agency), to contract with Simply Healthcare Plans, Inc. (Simply), for Medicaid managed care plans for HIV/AIDS patients in Regions 10 (Broward County) and Region 11 (Miami-Dade and Collier Counties) be invalidated and all proposals rejected? (Case Nos. 18-3507 and 18-3508) Must the Agency negotiate with Petitioner, South Florida Community Care Network, LLC, d/b/a Community Care Plan (Community), about a plan to provide HIV/AIDS Medicaid managed care services in Region 10 because it was the only responsive proposer of services that was a Provider Service Network (PSN)? (Case No. 18-3512) Must the Agency negotiate with Community to provide Medicaid managed care services in Region 10 for people with Serious Mental Illnesses because Community is a PSN? (Case No. 18-3511) Must the Agency contract with Community to provide Medicaid managed care services for Children with Special Needs in Region 10 because Community is a PSN? (Case No. 18-3513) Must the Agency negotiate with Community to provide Medicaid managed care services for Child Welfare patients in Region 10 because Community is a PSN? (Case No. 18-3514)
Findings Of Fact THE PARTIES Agency: Section 20.42, Florida Statutes, establishes the Agency as Florida’s chief health policy and planning agency. The Agency is the single state agency authorized to select eligible plans to participate in the Medicaid program. Positive: Positive is a Florida not-for-profit corporation operating a Medicaid health plan dedicated to serving people with HIV/AIDS. Positive serves about 2,000 patients in Florida. Positive’s health plan is accredited by the Accreditation Association for Ambulatory Healthcare. Its disease management program is accredited by the National Committee for Quality Assurance. Currently, the Agency contracts with Positive for a SMMC HIV/AIDS Specialty Plan serving Regions 10 and 11. Simply: Simply is a Florida for-profit corporation operating a Medicaid health plan dedicated to serving people with HIV/AIDS. Currently, the Agency contracts with Simply to provide a SMMC HIV/AIDS Specialty Plan for Regions 1 through 3 and 5 through 11. Simply has maintained the largest patient enrollment of all HIV/AIDs plans in Florida since Florida started its statewide Medicaid managed care program. Community Care: Community is a Florida limited liability company. It is a PSN as defined in sections 409.912(1)(b) and 409.962(14), Florida Statutes. Staywell: Staywell is the fictitious name for WellCare of Florida, Inc., serving Florida’s Medicaid population. Sunshine: Sunshine State Health Plan (Sunshine) is a Florida corporation. It offers managed care plans to Florida Medicaid recipients. THE INVITATION TO NEGOTIATE TIMELINE On July 14, 2017, the Agency released 11 ITNs plans for Florida’s Medicaid managed care program in 11 statutorily defined regions. Region 10, Broward County, and Region 11, Miami-Dade and Collier Counties, are the regions relevant to this proceeding. Part IV of chapter 409, creates a statewide, integrated managed care program for Medicaid services. This program called Statewide Medicaid Managed Care includes two programs, Managed Medical Assistance and Long-term Care. Section 409.966(2), directs the Agency to conduct separate and simultaneous procurements to select eligible plans for each region using the ITN procurement process created by section 287.057(1)(c). The ITNs released July 14, 2017, fulfilled that command. The Agency issued 11 identical ITNs of 624 pages, one for each region, in omnibus form. They provided elements for four types of plans. Some elements were common to all types. Others were restricted to a specific plan type defined by intended patient population. The plan types are comprehensive plans, long-term care plus plans, managed medical assistance plans, and specialty plans. Section 409.962(16) defines “Specialty Plan” as a “managed care plan that serves Medicaid recipients who meet specified criteria based on age, medical condition, or diagnosis.” Responding vendors identified the plan type or types that they were proposing. The Agency issued Addendum No. 1 to the ITNs on September 14, 2017. On October 2, 2017, the Agency issued Addendum No. 2 to the ITNs. Addendum 2 included 628 questions about the ITNs and the Agency’s responses to the questions. Florida law permits potential responders to an ITN to challenge the specifications of an ITN, including the addendums. § 120.57(3)(b), Fla. Stat. Nobody challenged the specifications of the ITNs. As contemplated by section 287.057(c)(2), the Agency conducted “a conference or written question and answer period for purposes of assuring the vendors’ full understanding of the solicitation requirements.” Positive, Community, and Simply, along with United Healthcare of Florida, Inc., HIV/AIDS Specialty Plan (United), submitted responses to the ITN in Region 10 proposing HIV/AIDS Specialty Plans. Community was the only PSN to propose an HIV/AIDS plan for Region 10. Positive, Simply, and United submitted replies to the ITN for Region 11, proposing HIV/AIDS Specialty Plans. Community, United, Staywell, and one other provider submitted proposals to provide SMI Specialty Plan services in Region 10. Community was the only responding PSN. Community, Sunshine, and Staywell submitted proposals to provide Child Welfare Specialty Plans (CW) in Region 10. Community was the only PSN. Community, Staywell, and two others submitted proposals to offer Specialty Plans for Children with Special Needs (CSN) in Region 10. Community was one of two responding PSNs. Proposal scoring began November 6, 2017, and ended January 16, 2018. The Agency announced its intended awards on April 24, 2018. On April 24, 2018, the Agency issued its notices of intent to award specialty contracts in Regions 10 and 11. The following charts summarize the Agency’s ranking of the proposals and its intended awards. The two highest ranked plans, which the Agency selected for negotiations, are identified in bold. Region 10 – Children with Special Needs Respondent Intended Award Ranking Staywell No 1 Community No 2 Miami Children’s Health Plan, LLC No 3 Our Children PSN of Florida, LLC No 4 Region 10 – Child Welfare Respondent Intended Award Ranking Staywell No 1 Sunshine Yes 2 Molina Healthcare of Florida, Inc. No 3 Community No 4 Region 10 – HIV/AIDS Respondent Intended Award Ranking Simply Yes 1 United No 2 Community No 3 Positive No 4 Region 10 – Serious Mental Illness Respondent Intended Award Ranking Staywell Yes 1 United No 2 Florida MHS, Inc. No 3 Community No 4 Region 11 – HIV/AIDS Respondent Intended Award Ranking Simply Yes 1 United No 2 Positive No 3 All of the Specialty Plan awards noticed by the Agency went to bidders who also proposed, and received, comprehensive plan awards. The protests, referrals, and proceedings before the Division summarized in the Preliminary Statement followed the Agency’s announcement of its intended awards. TERMS The voluminous ITN consisted of a two-page transmittal letter and three Attachments (A, B, and C), with a total of 34 exhibits to them. They are: Attachment A, Exhibits A-1 through A-8, Attachment B, Exhibits B-1 through B-3, and Attachment C, Exhibits C-1 through C-8. The ITN establishes a two-step process for selecting: an evaluation phase and a negotiation phase. In the evaluation phase, each respondent was required to submit a proposal responding to criteria of the ITN. Proposals were to be evaluated, scored, and ranked. The goal of the evaluation phase was to determine which respondents would move to negotiations, not which would be awarded a contract. The top two ranking Specialty Plans per specialty population would be invited to negotiations. In the negotiation phase, the Agency would negotiate with each invited respondent. After that, the Agency would announce its intended award of a contract to the plan or plans that the Agency determined would provide the best value. Together, the attachments and exhibits combined instructions, criteria, forms, certifications, and data into a “one size fits all” document that described the information required for four categories of managed care plans to serve Medicaid patients. The ITN also provided data to consider in preparing responses. The transmittal letter emphasized, “Your response must comply fully with the instructions that stipulate what is to be included in the response.” The ITNs identified Jennifer Barrett as the procurement officer and sole point of contact with the Agency for vendors. The transmittal letter is reproduced here. This solicitation is being issued by the State of Florida, Agency for Health Care Administration, hereinafter referred to as “AHCA” or “Agency”, to select a vendor to provide Statewide Medicaid Managed Care Program services. The solicitation package consists of this transmittal letter and the following attachments and exhibits: Attachment A Instructions and Special ConditionsExhibit A-1 Questions TemplateExhibit A-2-a Qualification of Plan Eligibility Exhibit A-2-b Provider Service Network Certification of Ownership and Controlling InterestExhibit A-2-c Additional Required Certifications and StatementsExhibit A-3-a Milliman Organizational Conflict of Interest Mitigation Plan Exhibit A-3-b Milliman Employee Organizational Conflict of Interest AffidavitExhibit A-4 Submission Requirements and Evaluation Criteria InstructionsExhibit A-4-a General Submission Requirements and Evaluation Criteria Exhibit A-4-a-1 SRC# 6 - General Performance Measurement ToolExhibit A-4-a-2 SRC# 9 - Expanded Benefits Tool (Regional) Exhibit A-4-a-3 SRC# 10 - Additional Expanded Benefits Template (Regional)Exhibit A-4-a-4 SRC# 14 - Standard CAHPS Measurement Tool Exhibit A-4-b MMA Submission Requirements and Evaluation Criteria Exhibit A-4-b-1 MMA SRC# 6 - Provider Network Agreements/Contracts (Regional)Exhibit A-4-b-2 MMA SRC# 14 - MMA Performance Measurement Tool Exhibit A-4-b-3 MMA SRC# 21 - Provider Network Agreements/Contracts Statewide Essential Providers Exhibit A-4-c LTC Submission Requirements and Evaluation CriteriaExhibit A-4-c-1 LTC SRC# 4 - Provider Network Agreements/Contracts (Regional) Exhibit A-4-d Specialty Submission Requirements and Evaluation CriteriaExhibit A-5 Summary of Respondent CommitmentsExhibit A-6 Summary of Managed Care Savings Exhibit A-7 Certification of Drug-Free Workplace ProgramExhibit A-8 Standard Contract Attachment B Scope of Service - Core Provisions Exhibit B-1 Managed Medical Assistance (MMA) ProgramExhibit B-2 Long-Term Care (LTC) ProgramExhibit B-3 Specialty Plan Attachment C Cost Proposal Instructions and Rate Methodology NarrativeExhibit C-1 Capitated Plan Cost Proposal TemplateExhibit C-2 FFS PSN Cost Proposal Template Exhibit C-3 Preliminary Managed Medical Assistance (MMA) Program Rate Cell Factors Exhibit C-4 Managed Medical Assistance (MMA) Program Expanded Benefit Adjustment Factors Exhibit C-5 Managed Medical Assistance (MMA) Program IBNR Adjustment Factors Exhibit C-6 Managed Medical Assistance (MMA) Program Historical Capitated Plan Provider Contracting Levels During SFY 15/16 Time Period Exhibit C-7 Statewide Medicaid Managed Care Data BookExhibit C-8 Statewide Medicaid Managed Care Data Book Questions and Answers Your response must comply fully with the instructions that stipulate what is to be included in the response. Respondents submitting a response to this solicitation shall identify the solicitation number, date and time of opening on the envelope transmitting their response. This information is used only to put the Agency mailroom on notice that the package received is a response to an Agency solicitation and therefore should not be opened, but delivered directly to the Procurement Officer. The ITN describes the plans as follows: Comprehensive Long-term Care Plan (herein referred to as a “Comprehensive Plan”) – A Managed Care Plan that is eligible to provide Managed Medical Assistance services and Long-term Care services to eligible recipients. Long-term Care Plus Plan – A Managed Care Plan that is eligible to provide Managed Medical Assistance services and Long-term Care services to eligible recipients enrolled in the Long-term Care program. This plan type is not eligible to provide services to recipients who are only eligible for MMA services. Managed Medical Assistance (MMA) Plan – A Managed Care Plan that is eligible to provide Managed Medical Assistance services to eligible recipients. This plan type is not eligible to provide services to recipients who are eligible for Long-term Care services. Specialty Plan – A Managed Care Plan that is eligible to provide Managed Medical Assistance services to eligible recipients who are defined as a specialty population in the resulting Contract. Specialty Plans are at issue. The ITN did not define, describe, or specify specialty populations to be served. It left that to the responding vendors. Beyond that, the ITN left the ultimate definition of the specialty population for negotiation, saying in Section II(B)(1)(a) of Attachment B, Exhibit B-3, “[t]he Agency shall identify the specialty population eligible for enrollment in the Specialty Plan based on eligibility criteria based upon negotiations.” Some respondents directly identified the specialty population. Simply’s transmittal letter stated that it proposed “a Specialty plan for individuals with HIV/AIDS.” Positive’s response to Exhibit A-4-d Specialty SRC 4, eligibility and enrollment, stated, “the specialty population for the PHC [Positive] plan will be Medicaid eligible, male and female individuals from all age groups who are HIV positive with or without symptoms and those individuals who have progressed in their HIV disease to meet the CDC definition of AIDS.” Some others left definition of the specialty population to be inferred from the ITN response. The result is that the ITN left definition of the specialty populations initially to the respondents and ultimately to negotiations between the Agency and successful respondents. Petitioners and Intervenors describe the populations that they propose serving as HIV/AIDS patients, patients with SMI, CSN, and child welfare populations. ITN respondents could have proposed serving only cancer patients, serving only obstetric patients, or serving only patients with hemophilia. The part of the ITN requiring a respondent to identify the plan type for which it was responding offered only four alternative blocks to check. They were: “Comprehensive Plan,” Long-Term Care Plus Plan,” “Managed Medical Assistance Plan,” or “Specialty Plan.” Attachment A to the ITN, labeled “Instructions and Special Conditions,” provides an overview of the solicitation process; instructions for response preparation and content; information regarding response submission requirements; information regarding response evaluation, negotiations, and contract awards; and information regarding contract implementation. Exhibits A-1 to A-3 and A-5 to A-7 of the ITN contain various certifications and attestations that respondents had to prepare and verify. Exhibit A-4 contains submission requirement components (SRCs) to which respondents had to prepare written responses. Exhibit A-8 contains the state’s standard SMMC contract. ITN Exhibit A-4-a contains 36 general submission requirements and evaluation criteria (General SRCs). ITN Exhibit A-4-b contains 21 MMA submission requirements and evaluation criteria (MMA SRCs). ITN Exhibit A-4-c contains 13 LTC submission requirements and evaluation criteria (LTC SRCs). ITN Exhibit A-4-d contains five specialty submission requirements and evaluation criteria (Specialty SRCs). The responses that the 36 SRCs require vary greatly. Some are as simple as providing documents or listing items. Others require completing tables or spreadsheets with data. Consequently, responses to some SRCS apparently could be reviewed in very little time, even a minute or less. Others requiring narrative responses might take longer. Examples follow. General SRC 1 required a list of the respondent’s contracts for managed care services and 12 information items about them including things such as whether they were capitated, a narrative describing the scope of work; the number of enrollees; and accomplishments and achievement. General SRC 2 asked for documentation of experience operating a Medicaid health plan in Florida. General SRC 3 asked for information confirming the location of facilities and employees in Florida. General SRC 12 requested a flowchart and written description of how the respondent would execute its grievance and appeal system. It listed six evaluation criteria. MMA SRC 2 asks for a description of the respondent’s organizational commitment to quality improvement “as it relates to pregnancy and birth outcomes.” It lists seven evaluation criteria. MMA SRC 10 asks for a description of the respondent’s plan for transition of care between service settings. It lists six evaluation criteria including the respondent’s process for collaboration with providers. Specialty SRC 1 asks for detailed information about respondent’s managed care experience with the specialty population. Specialty SRC 5 asks for detailed information about the respondent’s provider network standards and provides five evaluation criteria for evaluating the answers. Exhibit A-8 of the ITN contains the standard SMMC contract. Attachment B and Exhibits B-1 to B-3 of the ITN contain information about the scope of service and core provisions for plans under the SMMC program. Attachment C and Exhibits C-1 to C-8 of the ITN contain information related to the cost proposals and rate methodologies for plans under the SMMC program. The ITN permitted potential respondents to submit written questions about the solicitation to the Agency by August 14, 2017. Some did. On September 14, 2017, the Agency issued Addendum No. 1 to the ITN. Among other things, Addendum No. 1 changed the anticipated date for the Agency’s responses to respondents’ written questions from September 15 to October 2, 2017. The Agency issued Addendum No. 2 to the ITN on October 2, 2017. Addendum No. 2 included a chart with 628 written questions from potential respondents and the Agency’s answers. Attachment A at A 10-(d) makes it clear that the answers are part of the addendum. Both Addendums to the ITN cautioned that any protest of the terms, conditions, or specifications of the Addendums to the ITN had to be filed with the Agency within 72 hours of their posting. No respondent protested. Instructions for the A-4 Exhibits included these requirements: Each SRC contains form fields. Population of the form fields with text will allow the form field to expand and cross pages. There is no character limit. All SRCs, marked as “(Statewide)” must be identical for each region in which the respondent submits a reply. For timeliness of response evaluation, the Agency will evaluate each “(Statewide)” SRC once and transfer the score to each applicable region’s evaluation score sheet(s). The SRCs marked as “(Regional)” will be specific and only apply to the region identified in the solicitation and the evaluation score will not be transferred to any other region. The instructions continue: Agency evaluators will be instructed to evaluate the responses based on the narrative contained in the SRC form fields and the associated attachment(s), if applicable. Each response will be independently evaluated and awarded points based on the criteria and points scale using the Standard Evaluation Criteria Scale below unless otherwise identified in each SRC contained within Exhibit A-4. This is the scale: STANDARD EVALUATION CRITERIA SCALE Point Score Evaluation 0 The component was not addressed. 1 The component contained significant deficiencies. 2 The component is below average. 3 The component is average. 4 The component is above average. 5 The component is excellent. The ITN further explained that different SRCs would be worth different “weights,” based on the subject matter of the SRC and on whether they were General, MMA, LTC, or Specialty SRCs. It assigned weights by establishing different “weight factors” applied as multipliers to the score a respondent received on a criteria. For example, “Respondent Background/Experience” could generate a raw score of 90. Application of a weight factor of three made 270 the maximum possible score for this criteria. “Oversight and Accountability” could generate a raw score of 275. A weight factor of one, however, made the maximum score available 275. General SRC 6 solicits HEDIS data. HEDIS is a tool that consists of 92 measures across six domains of care that make it possible to compare the performance of health plans on an “apples-to-apples” basis. SRC 6 states: The respondent shall describe its experience in achieving quality standards with populations similar to the target population described in this solicitation. The respondent shall include, in table format, the target population (TANF, ABD, dual eligible), the respondent’s results for the HEDIS measures specified below for each of the last two (2) years (CY 2015/ HEDIS 2016 and CY 2016/ HEDIS 2017) for the respondent’s three (3) largest Medicaid Contracts (measured by number of enrollees). If the respondent does not have HEDIS results for at least three (3) Medicaid Contracts, the respondent shall provide commercial HEDIS measures for the respondent’s largest Contracts. If the Respondent has Florida Medicaid HEDIS results, it shall include the Florida Medicaid experience as one (1) of three (3) states for the last two (2) years. The respondent shall provide the data requested in Exhibit A-4-a-1, General Performance Measurement Tool[.] x x x Score: This section is worth a maximum of 160 raw points x x x For each of the measure rates, a total of 10 points is available per state reported (for a total of 360 points available). The respondent will be awarded 2 points if their reported plan rate exceeded the national Medicaid mean and 2 points if their reported plan rate exceeded the applicable regional Medicaid mean, for each available year, for each available state. The respondent will be awarded an additional 2 points for each measure rate where the second year’s rate is an improvement over the first year’s rate, for each available state. An aggregate score will be calculated and respondents will receive a final score of 0 through 150 corresponding to the number and percentage of points received out of the total available points. For example, if a respondent receives 100% of the available 360 points, the final score will be 150 points (100%). If a respondent receives 324 (90%) of the available 360 points, the final score will be 135 points (90%). If a respondent receives 36 (10%) of the available 360 points, the final score will be 15 points (10%). The SRC is plainly referring to the broad Medicaid- eligible population when it says “the target population (TANF, ABD, dual eligible).” “Dual eligible” populations are persons eligible for Medicaid and Medicare. There, as throughout the ITN, the ITN delineates between a target population of all Medicaid-eligible patients and a specialty population as described in a respondent’s ITN proposal. The clear instructions for SRC 6 require, “Use the drop-down box to select the state for which you are reporting and enter the performance measure rates (to the hundredths place, or XX.XX) for that state's Medicaid population for the appropriate calendar year.” Community did not comply. General SRC 14 solicits similar data, in similar form using a similar tool, about a respondent’s Consumer Assessment of Healthcare Providers and Systems (CAHPS). CAHPS data is basically a satisfaction survey. It asks respondents to provide “in table format the target population (TANF, ABD, dual eligible) and the respondent’s results for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) items/composites specified below for the 2017 survey for its adult and child populations for the respondent’s three (3) largest Medicaid Contracts (as measured by number of enrollees).” Just like General SRC 6 did with HEDIS data, General SRC 14 ITN instructed bidders to put their CAHPS data for the “target population (TANF, ABD, dual eligible)” “for the respondent’s three (3) largest Medicaid Contracts (measured by number of enrollees)” for multiple states into an excel spreadsheet “to the hundredths place[.]” Also, like General SRC 6, General SRC 14 includes an objective formula described in the ITN for scoring bidders’ CAHPS data. RANKING PROVISIONS Attachment A at (D)(4)(c)(2) stated: Each response will be individually scored by at least three (3) evaluators, who collectively have experience and knowledge in the program areas and service requirements for which contractual services are sought by this solicitation. The Agency reserves the right to have specific sections of the response evaluated by less than three (3) individuals. The ITN’s example of how total point scores would be calculated, discussed below, also indicated that some sections may be scored by less than three evaluators. The explanatory chart had a column for “[o]ther Sections evaluated by less than three (3) evaluators. ” The Agency’s policy, however, has been to assign at least three evaluators to score program specific SRCs. Attachment A at (D)(4)(e)(2) advised respondents how the agency will rank the competing responses. It was clear and specific, even providing an example of the process showing how the scores “will” be calculated. Step one of the explanatory chart stated that the Agency would calculate a total point score for each response. Step two stated that “[t]he total point scores will be used to rank the responses by an evaluator. . . .” Next, the rankings by the evaluator are averaged to determine the average rank for each respondent. This average ranking is critical because ranking is how the ITN said the Agency would select respondents for negotiation and how the Agency did select respondents for negotiation. The step two and step three charts, reproduced below, demonstrate that the ITN contemplated an evaluation process in which each response was to be evaluated in its entirety by three different evaluators, or maybe less than three, but indisputably in its entirety by those who evaluated it. This did not happen. Step 2 The total point scores will be used to rank the responses by evaluator (Response with the highest number of points = 1, second highest = 2, etc.). POINTS SUMMARY Evaluator A Evaluator B Evaluator C Evaluator D Respondent 446 Respondent 396 Respondent 311 Respondent 413 Respondent 425 Respondent 390 Respondent 443 Respondent 449 Respondent 397 Respondent 419 Respondent 389 Respondent 435 Respondent 410 Respondent 388 Respondent 459 Respondent 325 RANKING SUMMARY Evaluator A Evaluator B Evaluator C Evaluator D Respondent 1 1 Respondent 1 2 Respondent 1 4 Respondent 3 Respondent 2 2 Respondent 2 3 Respondent 2 2 Respondent 1 Respondent 3 4 Respondent 3 1 Respondent 3 3 Respondent 2 Respondent 4 3 Respondent 4 4 Respondent 4 1 Respondent 4 c) Step 3 An average rank will be calculated for each response for all the evaluators. Respondent 1 1+2+4+3=10÷4=2.5 Respondent 2 2+3+2+1=8÷4=2.0 Respondent 3 4+1+3+2=10÷4=2.5 Respondent 4 3+4+1+4=12÷4=3.0 PROVIDER SERVICE NETWORK PROVISIONS Florida law permits a PSN to limit services provided to a target population “based on age, chronic disease state, or medical condition of the enrollee.” This allows a PSN to offer a specialty plan. For each region, the eligible plan requirements of section 409.974(1) state, “At least one plan must be a provider service network if any provider service networks submit a responsive bid.” Section 409.974(3) says: “Participation by specialty plans shall be subject to the procurement requirements of this section. The aggregate enrollment of all specialty plans in a region may not exceed 10 percent of the total enrollees of that region.” The ITN addressed those requirements. The Negotiation Process section of Attachment A, Instructions and Special Conditions, says: The Agency intends to invite the following number of respondents to negotiation: Comprehensive Plans The top four (4) ranking Comprehensive Plans. Long-term Care Plus Plans The top two (2) ranking Long-term Care Plus Plans Managed Medical Assistance Plans The top two (2) ranking Managed Medical Assistance Plans Specialty Managed Medical Assistance Plans The top two (2) ranking Specialty Managed Medical Assistance Plans per specialty population. If there are no provider service networks included in the top ranked respondents listed above, the Agency will invite the highest ranked PSN(s) to negotiations in order to fulfill the requirements of Section 409.974(1), Florida Statutes and Section 409.981(1), Florida Statutes. Emphasis supplied. The ITN specifications in Section D.7, titled Number of Awards, state as follows about Specialty Plan awards: 7. Number of Awards In accordance with Sections 409.966, 409.974, and 409.981, Florida Statutes, the Agency intends to select a limited number of eligible Managed Care Plans to provide services under the SMMC program in Region 10. The Agency anticipates issuing the number of Contract awards for Region 10 as described in Table 5, SMMC Region, below, excluding awards to Specialty MMA Plans. Table 5 SMMC Region Region Total Anticipated Contract Awards Region 10 4 If a respondent is awarded a Contract for multiple regions, the Agency will issue one (1) Contract to include all awarded regions. The Agency will award at least one (1) Contract to a PSN provided a PSN submits a responsive reply and negotiates a rate acceptable to the Agency. The Agency, at its sole discretion, shall make this determination. A respondent that is awarded a Contract as a Comprehensive Plan is determined to satisfy the requirements in Section 409.974, Florida Statutes and Section 409.981, Florida Statutes and shall be considered an awardee of an MMA Contract and a LTC Contract. The Agency will issue one (1) Contract to reflect all awarded populations in all awarded regions. In addition to the number of Contracts awarded in this region, additional Contracts may be awarded to Specialty Plans that negotiate terms and conditions determined to be the best value to the State and negotiate a rate acceptable to the Agency. The Agency, at its sole discretion, shall make this determination. The Agency reserves the right to make adjustments to the enrollee eligibility and identification criteria proposed by a Specialty Plan prior to Contract award in order to ensure that the aggregate enrollment of all awarded Specialty Plans in a region will not exceed ten percent (10%) of the total enrollees in that region, in compliance with Section 409.974(3), Florida Statutes. If a respondent is awarded a Contract as a Specialty Plan and another plan type, the Agency will issue one (1) Contract to include all awarded populations in all awarded regions. A prospective vendor asked about the interplay of Specialty Plan options and the PSN requirements. The question and the answer provided in Addendum 2 follow: Q. Please clarify the number of PSN awards per region and how PSN awards will be determined based on the PSN's plan type (e.g., Comprehensive, LTC Plus, MMA, Specialty). As you know, Sections 409.974 and 409.981, Florida Statutes require one MMA PSN and one LTC PSN award per region (assuming a PSN is responsive) and the Agency has stated that an award to a Comprehensive Plan PSN will meet the requirements of both statutes. However, can the Agency further clarify whether other types of PSNs would meet the statutory requirements? Specifically, would a PSN LTC Plus award meet the requirements of Section 409.981, Florida Statutes? Similarly, would an award to a Specialty Plan PSN meet the requirements of Section 409.974, Florida Statutes? A. See Attachment A Instructions and Special Conditions, Section D Response Evaluations, and Contract Award, Sub-Section 7 Number of Awards. Yes, a PSN LTC Plus award would meet the requirements of Section 409.981(2). A Specialty Plan PSN would not meet the requirements of Section 409.974(1). The only reasonable interpretation of this answer is that Specialty Plan PSNs do not satisfy the requirement to contract with a responsive PSN imposed by section 409.974. None of the prospective vendors, including Community, challenged this clarification. EVALUATION PROCESS THE EVALUATORS The Agency selected 11 people to evaluate the proposals. The Agency assigned each person a number used to identify who was assigned to which task and to track performance of evaluation tasks. The procurement officer sent the evaluators a brief memo of instructions. It provided dates; described logistics of evaluation; emphasized the importance of independent evaluation; and prohibited communicating about the ITN and the proposals with anyone other than the procurement office. The Agency also conducted an instructional session for evaluators. Evaluator 1, Marie Donnelly: During the procurement, Ms. Donnelly was the Agency’s Chief of the Bureau of Medicaid Quality. She held this position for five years before resigning. This bureau bore responsibility for ensuring that the current SMMC plans met their contract requirements for quality and quality improvement measures. Her role specifically included oversight of Specialty Plans. Evaluator 2, Erica Floyd Thomas: Ms. Thomas is the chief of the Bureau of Medicaid Policy. She has worked for the Agency since 2001. Her Medicaid experience includes developing policies for hospitals, community behavioral health, residential treatment, and contract oversight. Before serving as bureau chief, she served as an Agency administrator from 2014 through 2017. Ms. Thomas oversaw the policy research and development process for all Medicaid medical, behavioral, dental, facility, and clinic coverage policies to ensure they were consistent with the state Plan and federal Medicaid requirements. Evaluator 3, Rachel LaCroix, Ph.D.: Dr. LaCroix is an administrator in the Agency’s Performance Evaluation and Research Unit. She has worked for the Agency since 2003. All her positions have been in the Medicaid program. Dr. LaCroix has served in her current position since 2011. She works with the performance measures and surveys that the current SMMC providers report to the Agency. Dr. LaCroix is a nationally recognized expert on healthcare quality metrics like HEDIS. She is also an appointee on the National Association of Medicaid Directors’ task force for national performance measures. Evaluator 4, Damon Rich: Mr. Rich has worked for the Agency since April 2009. He is the chief of the Agency’s Bureau of Recipient and Provider Assistance. This bureau interacts directly with AHCA’s current SMMC care providers about any issues they have, and with Medicaid recipients, usually about their eligibility or plan enrollment. Before Mr. Rich was a bureau chief, he worked as a field office manager for the Agency. Mr. Rich’s experience as bureau chief and field office manager includes oversight of the current SMMC Specialty Plans. Evaluator 5. Eunice Medina: Ms. Medina is the chief of the Agency’s Bureau of Medicaid Plan Management, which includes a staff of over 60 individuals, who manage the current SMMC contracts. Her experience and duties essentially encompass all aspects of the current SMMC plans. Ms. Medina started working with the Agency in 2014. Evaluator 6, Devona “DD” Pickle: Ms. Pickle most recently joined the Agency in 2011. She also worked for the Agency from November 2008 through November 2010. Ms. Pickle’s Agency experience all relates in some way to the Medicaid program. Since March 2013, Ms. Pickle has served as an administrator over managed care policy and contract development in the Bureau of Medicaid Policy. Her job duties include working with the current SMMC contractors. Ms. Pickle is also a Florida licensed mental health counselor. Evaluator 7, Tracy Hurd-Alvarez: Ms. Hurd-Alvarez has worked for the Agency’s Medicaid program since 1997. Since 2014, she has been a field office manager, overseeing compliance monitoring for all the current SMMC contractors. Before assuming her current position, Ms. Hurd-Alvarez implemented the LTC SMMC program. Evaluator 8, Gay Munyon: Ms. Munyon is currently the Chief of the Bureau of Medicaid Fiscal Agent Operations. Ms. Munyon began working with the Agency in April 2013. Ms. Munyon’s bureau oversees fulfillment of the Agency’s contract with the current SMMC fiscal agent. Her unit’s responsibilities include systems maintenance and modifications and overseeing the fiscal agent, which answers phone calls, processes claims, and processes applications. Ms. Munyon has 25 years of experience working with the Medicaid program. Evaluator 9, Laura Noyes: Ms. Noyes started working for the Agency in April 2011. Her years of Agency experience all relate to the Medicaid program, including overseeing six current comprehensive managed care plans by identifying trends in contractual non-compliance. Evaluator 10, Brian Meyer: Mr. Meyer is a CPA, who has worked for the Agency in the Medicaid program since 2011. He is currently chief of the Bureau of Medicaid Data Analytics. Mr. Meyer’s primary responsibility is overseeing the capitation rates for the current SMMC contractors. His experience includes Medicaid plan financial statement analysis, surplus requirement calculation analysis and, in general, all types of financial analysis necessary to understand financial performance of the state’s Medicaid plans. Evaluator 11, Ann Kaperak: Since April 2015, Ms. Kaperak has served as an administrator in the Agency’s Bureau of Medicaid Program Integrity. Ms. Kaperak’s unit oversees the fraud and abuse efforts of the current SMMC plans. She also worked for the Medicaid program from November 2012 through May 2014. Ms. Kaperak worked as a regulatory compliance manager for Anthem/Amerigroup’s Florida Medicaid program between May 2014 and April 2015. Positive and Community challenge the Agency’s plan selections by questioning the qualifications of the evaluators. The first part of their argument is that the evaluators did not have sufficient knowledge about HIV/AIDS and its treatment. The evidence does not prove the theory. For instance, Positive’s argument relies upon criticizing the amount of clinical experience evaluators had managing patients with HIV/AIDS. That approach minimizes the fact that the managed care plan characteristics involve so much more than disease- specific considerations. For instance, many of the components require determining if the respondent provided required documents, verifying conflict of interest documents, management structure, quality control measures, and the like. General SRCs asked for things like dispute resolution models (SRC 16), claims processing information (SRC 17), and fraud and abuse compliance plans (SRC 31). MMA SRCs included criteria, like telemedicine (SRC 4), demonstrated progress obtaining executed provider agreements (SRC 6), and a credentialing process (SRC 12). Specialty SRCs included criteria like copies of contracts for managed care for the proposed specialty population (SRC 1), specific and detailed criteria defining the proposed specialty population (SRC 4), and the like. The evidence does not prove that disease-specific experience is necessary to evaluate responses to these and other SRCs. SRC 6 involving HEDIS data and SRC 14 involving CAHPS data are two good examples. They required respondents to input data into a spreadsheet. All the evaluators had to do was determine what those numbers showed. Evaluation did not require any understanding of disease or how the measures were created. All the evaluator had to know was the number in the spreadsheet. The second part of the evaluator qualification criticisms is that the evaluators did not give adequate weight to some responses. Positive and Community just disagree with the measures requested and the evaluation of them. They conclude from that disagreement that the evaluators’ qualifications were deficient. The argument is not persuasive. The last sentence of paragraph 69 of Positive’s proposed recommended order exemplifies the criticisms of Positive and Community of the evaluators’ qualifications. It states, “The fact that PHC [Positive] was ranked last among competing HIV plans shows that the SRC evaluators did not understand enough about managing individuals with HIV/AIDs to score its proposal competently.” The argument is circular and “ipse dixit”. It does not carry the day. The collective knowledge and experience of the evaluators, with a total of 128 years of Medicaid experience, made them capable of reasonably evaluating the managed care plan proposals, including the Specialty plan proposals. The record certainly does not prove otherwise. EVALUATION PROCESS The Agency assigned the evaluators to the SRCs that it determined they were qualified to evaluate and score. The Agency did not assign entire responses to an evaluator for review. Instead it elected a piecemeal review process assigning various evaluators to various sections, the SRCs of each response. Paragraph 30 of the Agency’s proposed recommended order describes this decision as follows: Although the ITN had contemplated ranking each vendor by evaluator, based on an example in the ITN, such ranking presumed a process where all evaluators scored all or nearly all of the responses to the ITN, which had occurred in the procurement five years ago. In this procurement, each evaluator reviewed only a subset of SRCs based on their knowledge, and experience; therefore, ranking by evaluator was not logical because each had a different maximum point score. The initial SRC scoring assignments were: General SRCs 1 through 4, LTC SRCs 1 and 2, and Specialty SRC 1: Marie Donnelly, Laura Noyes, and Brian Meyer. General SRCs 5 through 8, MMA SRCs 1 through 7, LTC SRCs 3 and 4, and Specialty SRCs 1 and 2: Marie Donnelly, Erica Floyd- Thomas, and Rachel LaCroix. General SRCs 9 through 14, MMA SRCs 8 through 11, LTC SRCs 5 through 7, and Specialty SRC 4: Damon Rich, Eunice Medina, and DD Pickle. General SRCs 15 through 17, MMA SRCs 12 and 13, and LTC SRCs 8 through 10: Damon Rich, Tracy Hurd-Alvarez, Gay Munyon. General SRCs 18 through 25, MMA SRCs 14 through 20, LTC SRCs 11 and 12, and Specialty SRC 5: Erica Floyd-Thomas, Eunice Medina, and DD Pickle. General SRCs 26 through 33 and LTC SRC 13: Gay Munyon, Ann Kaperak, and Brian Meyer. General SRCs 34 through 36 and MMA SRC 21: Marie Donnelly, Rachel LaCroix, and Tracy Hurd-Alvarez. The ranking process presented in the ITN and described in paragraphs 62-64, contemplated ranking each respondent by evaluator. The Agency carried this process over from an earlier procurement. In this procurement, despite what the ITN said, the Agency assigned responsibilities so that each evaluator reviewed only a subset of SRCs. Therefore, the ranking of responses by evaluator presented in the ITN could not work. It was not even possible because no one evaluator reviewed a complete response and because each SRC had a different maximum point score. Instead, the Agency, contrary to the terms of the ITN, ranked proposals by averaging the “total point scores” assigned by all of the evaluators. The Agency considered issuing an addendum advising the parties of the change. The addendum would have informed the respondents and provided them an opportunity to challenge the change. The Agency elected not to issue an addendum. EVALUATION AND SCORING The evaluators began scoring on November 6, 2017, with a completion deadline of December 29, 2017. The 11 evaluators had to score approximately 230 separate responses to the ITNs. The evaluators had to score 67,175 separate items to complete the scoring for all responses for all regions for all types of plans. No one at the Agency evaluated how much time it should take to score a particular item. None of the parties to this proceeding offered persuasive evidence to support a finding that scoring any particular item would or should take a specific length of time or that scoring all of the responses would or should take a specific length of time. Evaluators scored the responses in conference room F at the Agency’s headquarters. This secure room was the exclusive location for evaluation and scoring. Each evaluator had a dedicated workspace equipped with all tools and resources necessary for the task. The workspaces included a computer terminal for each evaluator. The system allowed evaluators to review digital copies of the ITN and proposals and to enter evaluation points in spreadsheets created for the purpose of recording scores. Evaluators also had access to hard copies of the proposals and the ITN. The Agency required evaluators to sign in and to sign out. The sign-in and sign-out sheets record the significant amount of time the evaluators spent evaluating proposals. Evaluators were not permitted to communicate with each other about the responses. To minimize distractions, the Agency prohibited cell phones, tablets and other connected devices in the room. The Agency also authorized and encouraged the evaluators to delegate their usual responsibilities. Agency proctors observed the room and evaluators throughout the scoring process. They were available to answer general and procedural questions and to ensure that the evaluators signed in and signed out. A log sheet documented how much time each evaluator spent in the scoring conference room. Some evaluators took extensive notes. For example, Ms. Median took over 200 pages of notes. Similarly, Ms. Munyon took nearly 400 pages of typewritten notes. The evaluators worked hard. None, other than Dr. LaCroix, testified that they did not have enough time to do their job. The computer system also automatically tracked the evaluators’ progress. Tracking reports showed the number of items assigned to each evaluator and the number of scoring items completed. The first status report was generated on December 8, 2017, approximately halfway through the scheduled scoring. At that time, only 28 percent of the scoring items were complete. Ms. Barrett usually ran the status reports in the morning. She made them available to the evaluators to review. The pace of evaluation caused concern about timely completion and prompted discussions of ways to accelerate scoring. Because it was clear that the majority of the evaluators would not complete scoring their SRCs by December 29, 2017, the Agency extended the scoring deadline to January 12, 2018. It also extended the hours for conference room use. Most respondents filed proposals for more than one type of plan and more than one region. This fact combined with the provision in the instructions saying that all statewide SRC responses must be identical for each region and that scores would transfer to each applicable region’s score sheets, enabled evaluators to score many SRCs just once. The system would then auto-populate the scores to the same SRC for all proposals by that respondent. This time saving measure permitted scoring on many of the items to be almost instantaneous after review of the first response to an SRC. The fact that so many respondents submitted proposals for so many regions and types of plans provided the Agency another opportunity for time-saving. The Agency loaded Adobe Pro on the evaluators’ computers as a timesaving measure. This program allowed the evaluators to compare a bidder’s Comprehensive Plan Proposal to the same company’s regional and Specialty Plan proposals. If the Adobe Pro comparison feature showed that the proposal response was the same for each plan, the Agency permitted evaluators to score the response once and assign the same score for each item where the respondent provided the same proposal. This speeded scoring. It, however, meant that for SRCs where evaluators did this, that they were not reviewing the SRC response in the specific context of the specialty plan population, each of which had specific and limited characteristics that made them different from the broader General and MMA plan populations. This is significant because so many SRCs required narrative responses where context would matter. There is no Specialty SRCs A-4 instruction requirement for specialty plans analogous to the requirement that responses for statewide SRCs must be identical for each region. In other words, the instructions do not say all SRCs marked as statewide must be identical for each specialty plan proposal and that the Agency will evaluate each Statewide SRC once and transfer the score to each applicable Specialty Plan score. In fact, according to the procurement officer, the Agency expected that evaluators would separately evaluate and score the statewide SRCs for Comprehensive Plans and for Specialty Plans, even if the same bidder submitted them. Despite the Agency’s expectation and the absence of an authorizing provision in the ITN, many evaluators, relying on the Adobe Pro tool, copied the SRC scores they gave to a respondent’s comprehensive plan proposal to its specialty plan proposal if the respondent submitted the same response to an SRC for a Comprehensive Plan and a Specialty Plan. For instance, Ms. Thomas (Evaluator 2) and Ms. Munyon (Evaluator 8) did this to save time. Ms. Donnelly (Evaluator 1) did this even when the comprehensive and specialty responses were not identical. This does not amount to the independent evaluation of the responses pledged by the ITN. On separate days, Evaluator 1 scored 1,315 items, 954 items, 779 items and 727 items. On separate days, Evaluator 2 scored 613 items, 606 items, 720 items, 554 items and 738 items. Evaluator 4 scored 874 items on one day. Evaluator 5 scored 813 items in one day. Evaluator 6 scored 1,001 items in one day. Evaluator 8 scored 635 items in one day. The record does not identify the items scored. It also does not permit determining how many of the item scores resulted from auto-population or assignment of scores based upon previous scoring of an identical response. It bears repeating, however, that the record does not support any finding on how long scoring the response to one SRC or an entire response could reasonably be expected to take. Even with the extended scoring period and time-saving measures, the Agency concluded that Evaluator 3 would not be able to finish all of the SRCs assigned to her. Rather than extend the deadline for scoring a second time, the Agency decided to reassign the nine of Evaluator 3’s SRCs that she had not begun scoring to two other evaluators. The Agency did not include scores of other SRCs for which Evaluator 3 had not completed scoring. The Agency only counted Evaluator 3’s scores for an SRC if she scored the SRC for everyone. The result was that only two people scored nine of the Specialty Plan SRCs. The Agency did not reassign all of Evaluator 3’s SRCs’. It only reassigned the SRCs to evaluators who were qualified to evaluate the items, who were not already assigned those items to score, and who had already finished or substantially completed their own evaluations. The decision to reassign the SRCs was not based on any scoring that had already been completed. The Agency did not allow changes to data submitted by any of the vendors. It allowed vendors to exchange corrupted electronic files for ones which could be opened and allowed vendors to exchange electronic files to match up with the paper copies that had been submitted. The Agency allowed Community to correct its submission where it lacked a signature on its transmittal letter and allowed Community to exchange an electronic document that would not open. It did not allow Community to change its reported HEDIS scores, which were submitted in the decimal form required by the instructions. Community erred in the numbers that it reported. There is no evidence showing that other vendors received a competitive or unfair advantage over Community in the Agency’s review of the SMI Specialty Plan submission for Region 10. There was no evidence that the Agency allowed any other vendors to change any substantive information in their submittals for that proposed specialty in that region. HEIDIS ISSUES Positive asserts that Simply’s proposal is non- responsive because Simply submitted HEDIS data from the general Medicaid population in response to SRC 6 and MMA SRC 14. Positive contends that Simply obtained a competitive advantage by supplying non-HIV/AIDS HEDIS data in response to SRC 6 and MMA SRC 14 because HIV/AIDS patients are generally a sicker group and require more care and because some HEDIS measures cannot be reported for an HIV/AIDS population. HEDIS stands for Healthcare Effectiveness and Data Information Set and is a set of standardized performance measures widely used in the healthcare industry. The instructions for both SRC 6 and MMA SRC 14 provide, in relevant part: The respondent shall describe its experience in achieving quality standards with populations similar to the target population described in this solicitation. The respondent shall include in table format, the target population (TANF, ABD, dual eligible), the respondent’s results for the HEDIS measures specified below for each of the last two (2) years (CY 2015/HEDIS 2016 and CY 2016/HEDIS 2017) for the respondent’s three (3) largest Medicaid Contracts (measured by number of enrollees). If the respondent does not have HEDIS results for at least three (3) Medicaid Contracts, the respondent shall provide commercial HEDIS measures for the respondent’s largest Contracts. If the Respondent has Florida Medicaid HEDIS results, it shall include the Florida Medicaid experience as one (1) of three (3) states for the last two (2) years. (JE 1 at 75 (SRC 6); JE 1 at 158 (MMA SRC 14)). SRC 6 and MMA SRC 14 instruct respondents to provide HEDIS measures for “the target population (TANF, ABD, dual eligible).” Id.. TANF, ABD, and dual eligible are eligibility classifications for the Medicaid population. The Agency sought information regarding the target Medicaid-eligible population, even from respondents proposing a Specialty Plan, because Specialty Plans are required to serve all of the healthcare needs of their recipients, not just the needs related to the criteria making those recipients eligible for the Specialty Plan. Following the instructions in SRC 6 and MMA SRC 14, Simply provided HEDIS data from the Medicaid-eligible population for its three largest Medicaid contracts as measured by the total number of enrollees. For the requested Florida HEDIS data, Simply utilized legacy HEDIS data from Amerigroup Florida, Inc., a Comprehensive Plan. Amerigroup and Simply had merged in October of 2017. Therefore, at the time of submission of Simply’s proposal, the HEDIS data from Amerigroup Florida was the data from Simply’s largest Medicaid contract in Florida for the period requested by the SRCs. Positive asserts that the Agency impermissibly altered scoring criteria after the proposals were submitted when the Agency corrected technical issues within a HEDIS Measurement Tool spreadsheet. SRC 6 and MMA SRC 14 required the submission of numeric data for the requested HEDIS performance measures. To simplify submission of the numeric data for the requested HEDIS performance measures, the Agency required respondents to utilize a HEDIS Measurement Tool spreadsheet. The evaluation criteria for SRC 6 and MMA SRC 14 provided that respondents will be awarded points if the reported HEDIS measures exceed the national or regional mean for such performance measures. Some respondents, including Positive, entered “N/A,” “small denominator,” or other text inputs into the HEDIS Measurement Tool. During the evaluation and scoring process, the Agency discovered that if a respondent input any text into the HEDIS Measurement Tool, the tool would assign random amounts of points, even though respondents had not input measureable, numeric data. The Agency reasonably resolved the problem by removing any text and inserting a zero in place of the text. The correction of the error in the HEDIS Measurement Tool prevented random points from being awarded to respondents and did not alter scores in any way contrary to the ITN. It was reasonable and fair to all respondents.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order rejecting all r esponses to the ITNs to provide a Medicaid Managed Care plan for patients with HIV/AIDS in Regions 10 and 11. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order inviting Community to negotiate to provide Medicaid Managed Care plan in Region 10 for patients with serious mental illness. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order inviting Community to negotiate to provide a Medicaid Managed Care plan in Region 10 for patients with serious mental illness. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order inviting Community to negotiate to provide a Medicaid Managed Care plan in Region 10 for c hild w elfare specialty services. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order awarding Wellcare of Florida, Inc., d/b/a Staywell Health Plan of Florida, a contract for a specialty Medicaid Managed Care plan for patients with Serious Mental Illness in Region 10. Based on the foregoing Findings of Fact and Conclusions of Law it is RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the Petition in Case No. 18-3513. DONE AND ENTERED this day of , , in Tallahassee, Leon County, Florida. S JOHN D. C. NEWTON, II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this day of , .
The Issue Whether Department of Health and Rehabilitative Services ("HRS") Rules 10- and 10-17.005 (originally published as 10-16.001, 10-16.005), Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Standing Humana is a corporation engaged in the business of constructing and operating hospitals in Florida. It has applied to HRS for a certificate of need to construct and operate a 100-bed acute care hospital to be located south of the St. Johns River in the area known as Mandarin, in Duval County, Florida. The challenged Subdistrict Rule places this area in Subdistrict 3 of HRS District IV. Humana's (Mandarin) application for a certificate of need (CON) was denied by HRS on February 23, 1983, and Humana requested a formal Section 120.57(1), hearing. The case was then transferred to the Division of Administrative Hearings and assigned Case Number 83-934. The final hearing in that CON case began on September 6, 1983, and recessed on September 7, 1983. In the instant case--on Humana's request, and without objection by HRS--official recognition was given to the transcript of that hearing, as filed with the Division of Administrative Hearings. Prior to the CON hearing in Case Number 83-934, on August 12, 1983, HRS published proposed Rules 10-16.001 and 10-16.005 ("Subdistrict Rule") at Volume 9, Number 32, pages 1952 through 1957, Florida Administrative Weekly. (Petitioner's Exhibit No. 1) After the CON hearing recessed, and after a public hearing on the proposed Subdistrict Rule, HRS published changes to the rule on September 23, 1983, at Volume 9, No. 38, page 2475-2476, Florida Administrative Weekly. These changes were made in response to comments which HRS received at a public hearing held on the proposed rule. (Petitioner's Exhibit No. 2) On September 26, 1983, HRS filed the Subdistrict Rule with the Department of State for adoption, effective October 16, 1983. (Petitioner's Exhibit No. 3) Thereafter, the Bureau of Administrative Code, Department of State, informed HRS that since other rules were already numbered in Chapter 10-16, Florida Administrative Code, the Subdistrict Rule would be published in Chapter 10-17, Florida Administrative Code. (Petitioner'S Exhibit No. 28) At the CON hearing, Humana attempted to introduce evidence which HRS challenged as inconsistent with Rule 10-5.11(23) the state-wide acute care bed- need rule, and the Subdistrict Rule--then a proposed rule not yet adopted by HRS. The presiding hearing officer, acknowledging the "proposed rule" status of the Subdistrict Rule, sustained HRS objections to the admission of evidence proposing a methodology, or subdistrict bed-need allocations, inconsistent with those contained in the (proposed) Subdistrict Rule. He did, however, rule that the two non-agency parties could offer evidence for the purpose of showing that HRS, or the local health council in conjunction with HRS, had developed bed-need formula or techniques for subdistricts beyond, or inconsistent with, the proposed Subdistrict Rule and the underlying local health council's district plan. (DOAH Case No. 83-934, pp. 220-221, Transcript of Hearing). II. The Rule Adoption Process In response to Section 381.494(7)(b), Florida Statutes (1983), requiring local health councils to develop district plans using a "uniform methodology," HRS transmitted to the councils written guidelines for designating and allocating bed-need among various subdistricts. (Petitioner's Exhibit Dos. 9 and 10) The statute does not express or imply that the word, "methodology" should be given a meaning other than that assigned by ordinary and common usage. Webster's Seventh New Collegiate Dictionary defines the term as: "a body of methods, rules and postulates; a particular procedure or set of procedures." A methodology is not necessarily a mathematical formula. These guidelines, transmitted to the local health councils in early 1983, describe the relationship between HRS and the councils, the format and content elements of district health plans, and the requirements for stating district health care policies and priorities. Examples are provided. The guidelines require that local plans contain a district health profile--an overview of the area's population characteristics, community health status and prevailing health related attitudes and behaviors. Components are also required, including detailed information on the district's health care resource inventories, costs and utilization patterns, analysis of local services as well as recommendations and priorities for future health systems development. For at least three types of existing health care facilities--acute care hospitals, nursing homes, and psychiatric specialty hospitals information must be provided on current capacity, physical status, service areas, and recommendations for future developments. A time frame is imposed for accomplishing each phase of the plan development, with the final phase adoption of the local health plan--to be accomplished by December, 1983. Finally, the guidelines, at page 15, point out the statutory requirement that HRS adopt, by rule, those elements of the approved district plans necessary for review of applications for certificates of need: Adoption Into Rules Section 7(b) of Chapter 381.493 states that "Elements of an approved district plan necessary to the review of any certificate of need application shall be adopted by the Department as a part of its rules." This should be kept in mind through- out the plan development process. Local policies and priorities are the items most pertinent to certificate of need review since information on bed need and capacity are either determined at the state level or must be updated to the time of certificate of need application, review and appeal. There- fore, the local health council will be ex- pected to develop a separate submission of their policies and priorities in the proper format for rule promulgation within thirty days of the adoption of the local health plan. State agency staff will assist in the development and refinement of these documents. (Petitioner'S Exhibit No. 9) HRS interpreted its responsibility under Section 381.494, as one of assuring that district health plans were consistent with the state-wide uniform bed-need methodology prescribed in Rule 10-5.11(23). Under subparagraph "d" of that rule, local health plans must designate subdistricts according to HRS guidelines. Subparagraph "e" requires that beds be allocated to designated subdistricts consistent with the total number of beds allocated to the district under the rule, and consistent with subparagraph "i," which contains geographic accessibility standards. Rule 10-5.11(23) * * * * * Acute Care Service Subdistrict Designation. Acute care service sub- district designations shall be adopted, as necessary, by each Local Health Council as an element of its local health plan according to guidelines developed by the State Health Planning Agency. Designations will become effective for the purposes of this rule upon the filing of the adopted local health plan acute care subdistricting elements with the Secretary of State. Subdistrict Bed Allocations. Subdistrict bed allocations by type of service shall be made by the Local Health Councils consistent with the district total acute care bed allocation as determined by the methodology contained in paragraph (f) below, as well as any adjustments to the allocation as determined by the provisions of paragraphs and (h) below. Such allocations shall also be consistent with the provisions 9f paragraph (i) and the requirements of Section 381.494(7)(b) , Florida Statutes. * * * * * Geographic Accessibility Considerations. Acute care hospital beds should be available and accessible within an automobile travel time of 30 minutes under average travel conditions to at least 90 percent of the population residing in an urban area subdistrict. Acute care hospital beds should be available and accessible within a maximum automobile travel time of 45 minutes under average travel conditions to at least 90 percent of the population residing in a rural area sub- district. The elements of the District IV health plan contained in the Sub- district Rule are consistent with the uniform methodology prescribed in Rule 10-5.11(23) and HRS guidelines. In response to these guidelines, the District IV health council adopted and transmitted to HRS, on July 7, 1983, the acute care component of the district health plan. After the district council approved this component and allocated beds to the various subdistricts, HRS supplied updated population figures resulting in an increase in the total number of beds allocated to the district. The council's staff then adjusted the number of beds allocated to the subdistricts on a pro rata basis. These adjustments were consistent with the council's policy, as reflected by its approval of the acute care component. No evidence has been presented to show that the council's staff lacked authority to make these adjustments. (Petitioner's Exhibit No. 7) In addition to allocating district wide bed-need among the subdistricts of District IV, the acute care component contains detailed information and analysis concerning acute care bed-need. This information is pertinent but not necessary to the review of CON applications in District IV. (Petitioner's Exhibit No 7) The challenged Subdistrict Rule simply designates subdistricts and allocates bed-need among them; other data and analysis contained in the acute care component are not included. HRS, however, is now drafting an addition to the Subdistrict Rule (Section 10-17.005), titled "subsection (3), Acute Care Policies and Priorities," which incorporates additional portions of the district plan for use in reviewing CON applications in District IV. This draft rule allows exceptions based on local conditions: When there are more than one widely separated hospital service areas located within a single subdistrict, such as St. Augustine in South Duval Subdistrict 3, Bunnell and Daytona Beach in Subdistrict 4, and unforeseen growth, change and makeup of population, or other circumstances cause a significant increase in the demand for inpatient care within one of the service areas, the State should make exception to the District Health Plan when it is reasonable and logical to do so. (Petitioner'S Exhibit No. 34) This provision was contained in the district plan at the time HRS adopted the Subdistrict Rule. (Petitioner'S Exhibit No. 7) The Subdistrict Rule, with the exception of St. Lukes' Hospital, allocates beds among the subdistricts on the basis of the number of patient-days currently utilized by the hospitals in each subdistrict, projected for 1988. St. Lukes' Hospital, now located on the north side of the St. John's River in Subdistrict 1, will move to the south side of the St. John's River in Subdistrict 3, the subdistrict where Humana seeks to build its Mandarin hospital. This move from north to south is accounted in the subdistrict allocation by assuming that 34 percent of the current (north) St. Lukes' Hospital patient-days will come with the hospital when it moves from Subdistrict 1 to Subdistrict 3, and that the remainder will come from Subdistrict 3 (south) patients. With 66 percent of St. Lukes' bed capacity allocated for Subdistrict 3, there will be no additional bed-need in that subdistrict for years. HRS prepared an economic impact statement (EIS) in connection with its adoption of the subdistrict rules, including the Subdistrict Rule under challenge. The EIS addresses the agency's cost to implement the proposed rules, the cost or economic benefit to persons directly affected, and the affect on competition. The data and methods used in preparing the EIS are also briefly summarized.
The Issue Whether Petitioner meets the requirements for licensure as a Health Care Risk Manager?
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of Health Care Risk Managers in Florida pursuant to sections 395.0971 through 395.0975, Florida Statutes. Petitioner holds a Master of Science Administration from the University of West Florida and is licensed in the state of Florida as a Clinical Laboratory Supervisor. Petitioner filed an application for licensure with AHCA as a Health Care Risk Manager on May 11, 2011. The application was reviewed by Mark Hajdukiewicz, a Health Services and Facilities Consultant employed by AHCA. Section 6 of the application entitled "Qualifications for Licensure" states: "In the appropriate section below, check all of the applicable criteria. Complete only one section." The "sections" on the application are ways or approaches from which an applicant may choose to demonstrate his or her qualifications for licensure as a Health Care Risk Manager. On this initial application, Petitioner completed three sections. By letter dated June 2, 2011 (the Omissions Letter), Mr. Hajdukiewicz notified Petitioner that AHCA received her initial application and, after review, found it to be incomplete. The Omissions Letter further stated: Select one approach to licensure. Resubmit amended pages 4 and 5 of the Health Care Licensing Application form RM-001, Revised 12/2010. Evidence of credentials as a Health Care Administrator as defined in Rule 59A- 10.032(14), F.A.C. An official transcript submitted from the college that satisfies the above rule. The Agency has received the 120 hours certificate. Or Evidence of credentials as a Health Care Professional as defined in Rule 59A- 10.032(15), F.A.C. The application has license SU 3074, a Clinical Laboratory Supervisor, unfortunately that license does not meet the Rule requirements. The Agency has received the 120 hours certificate. Or Official transcripts that include coursework which meets two years of college level studies pursuant to Rule 59A-10.035, F.A.C. Please send the required information no later than 21 days from the receipt of this letter. If the applicant fails to submit all the information required in the application within 21 days of being notified by AHCA of the omissions, the application will be denied and the fees shall be forfeited pursuant to subsection 408.806(3)(b), Florida Statutes. (emphasis in original) Petitioner submitted a revised section 6 of her application on or about June 23, 2011. On this revised portion of her application, Petitioner elected to seek licensure based upon her credentials as a Health Care Administrator as defined in Florida Administrative Code Rule 59A-10.032(14). Petitioner also submitted a copy of her transcript for a Master of Science Administration from the University of West Florida. Mr. Hajdukiewicz reviewed Petitioner's revised application and determined that the documentation submitted by Petitioner in support of her application did not meet the criteria set forth in rule 59A-10.032(14), which defines a health care administrator. Mr. Hajdukiewicz forwarded a recommendation that the application be deemed incomplete to his supervisor, Laura MacLafferty. Ms. MacLafferty concurred with Mr. Hajdukiewicz's recommendation and issued the Notice of Intent to Deem Application Incomplete and Withdrawn from Further Review. Subsequently, Petitioner submitted a copy of her transcript reflecting the curriculum for her master's degree program from the University of West Florida. Although, as a transcript copy, it was extremely difficult to read, Ms. MacLafferty reviewed the curriculum and determined that it was insufficient to warrant reversal of the Agency's decision. At hearing, Petitioner acknowledged that her degree does not say "hospital" as specified in rule 59A-10.032(14) (i.e., hospital administration, hospital finance, hospital management). As Petitioner elected to qualify for licensure pursuant to demonstrating attainment of credentials as a Health Care Administrator as defined in rule 59A-10.032(14), her application was not evaluated pursuant to the other possible ways of demonstrating qualifications for licensure.1/
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order denying Petitioner's application for licensure as a Health Care Risk Manager, without prejudice to reapply under the other criteria specified in Florida Administrative Code Rules 59A-10.032(15) and 59A-10.035, and section 6 of the licensure application form. DONE AND ENTERED this 8th day of November, 2011, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS 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 8th day of November, 2011.
The Issue Whether Respondent should recoup Medicaid payments made to Petitioner for health care services provided to eight patients.
Findings Of Fact Petitioner, Indian River Memorial Hospital, Inc., (Hospital), has contracted with Respondent, Agency for Health Care Administration (AHCA), to provide services to Medicaid patients. The parties have agreed that there is a dispute for Medicaid reimbursement for goods and services provided to eight patients: S.G., J.D., R.J., C.A., G.M., S.S., M.P., and C.T. The Agency has paid the Hospital for the services rendered to these eight patients and seeks to recoup the payment based on a retrospective review by a peer review organization, Keystone Peer Review Organization (KePro). The Agency claims that either the admission or a portion of the length-of-stay for the eight patients was medically unnecessary. Services were provided to C.T. in 1994 and to the remainder of the patients at issue in 1995. Payment for Medicaid services is on a per diem basis. The rate for 1994 is $473.22 per day, and the rate for 1995 is $752.14. The Agency contracted with KePro to do a review of the Medicaid payments to the Hospital. KePro employs nurses to review the patient files based on criteria on discharge screens. If the services meet the criteria, there is no further review and the payment is approved. If the nurse determines that the services do not meet the criteria on the discharge screens, the patient's files are reviewed by a board certified physician, who in this case would be a psychiatrist. If the physician determines that the services are not medically necessary, a letter is sent to the Medicaid provider, giving the provider an opportunity to submit additional information. Additional information submitted by the provider is reviewed by a board certified physician. If the doctor concludes that the services are still medically unnecessary, the provider is notified that that services do not qualify for reimbursement and the provider may ask for a reconsideration of the denial. If the provider seeks reconsideration, the file is reviewed by a physician, and the provider has an opportunity to be present during the review. If the physician determines that the services are medically unnecessary, KePro sends a letter to the Agency stating the reasons for denial. The denial letters that KePro sends to the Agency are reviewed by the Medical Director of KePro, who is not a psychiatrist. Dr. John Sullenberger, the Agency's Medicaid physician, reviews the KePro denial letters sent to the Agency, and 99.9 percent of the time he agrees with the findings of KePro regarding whether the services were medically necessary. Dr. Sullenberger does not review the patient's charts when he does this review. The Agency sends a recoupment letter to the Medicaid provider requesting repayment for services provided. Patient S.G., a 12 year-old boy, was being treated pursuant to the Baker Act. He was admitted to the Hospital on March 8, 1995, and discharged on March 25, 1995. The Agency denied Medicaid reimbursement for the admission and the entire length-of-stay for S.G. based on KePro's determination that it was not medically necessary for the services to S.G. to be rendered in an acute care setting because the patient was neither suicidal nor homicidal. Three to five days prior to his admission to the Hospital, S.G. had attempted to stab his father. He also had further violent episodes, including jumping his father from behind and choking him and pulling knives on his parents. S.G. had a history of attention deficit and hyperactive disorder. He had been using multiple substances, such as alcohol, LSD, cocaine, and marijuana, prior to his admission. His behavior was a clear reference that he was suffering from a psychosis. A psychosis is a significant inability to understand what is reality, including delusions of false beliefs, hallucinations, hearing and seeing things which do not exist, and ways of thinking that are bizarre. Psychosis is a reason to admit a patient, particularly combined with substance abuse. S.G.'s treating psychiatrist noted that S.G. had tangentiality, which means that his thoughts did not stay together. He did not have a connection between thoughts, which is a sign of a psychosis. The chart demonstrated that S.G. had disorder thinking, which includes the possibility of a psychosis. There was also a reference in the charts to organic mental disturbance which could infer brain damage as the cause for the mental disturbance. Two days after admission, there was an issue of possible drug withdrawal because S.G. was agitated and anxious and showed other symptoms. Drug withdrawal, psychosis, and a demonstration of overt violence require a stay in an acute care facility. There was some indication that S.G. was suicidal. While in the Hospital he was placed under close observation, which is a schedule of 15-minute checks to determine if the patient was physically out of harm's way. S.G. was started on an antidepressant, Wellbutrin, because the treating physician thought S.G. was becoming increasingly depressed and was having trouble organizing his thoughts. Antidepressants, as contrasted to a medication such as an antibiotic, may take a minimum of two to three weeks before the patient will benefit from the full effect of the drug. It is difficult to stabilize the dosage for an antidepressant on an outpatient basis. S.G. was taking Ritalin, which is commonly used for children with attention deficit, hyperactivity disorders. During his stay at the Hospital, S.G. was engaging in strange behavior, including absence seizures. On March 16, 1995, he was still lunging and threatening harm. On March 20, 1995, he was still unstable and at risk. The dosage of Wellbutrin was increased. On March 21 and 22, 1995, S.G. was still threatening and confused. S.G. was discharged on March 25, 1995. The admission and length-of-stay for S.G. were medically necessary. Patient J.D. was a 16 year-old boy who was admitted to the Hospital on March 7, 1995, and discharged on March 14, 1995. The Agency denied the admission and entire length-of-stay based on KePro's determination that the patient was not actively suicidal or psychotic and services could have been rendered in a less acute setting. J.D. was admitted from a partial hospitalization program pursuant to the Baker Act because he was observed by a health care professional banging his head against the wall and throwing himself on the floor. He had a history of depression and out-of-control behavior, including being a danger to himself and running away. At the time of his admission, he was taking Prozac. Banging his head against the wall can mean that the patient is psychotic, can cause brain damage, and can be dangerous if the cause of the behavior is unknown. Admission to the Hospital was justified because the patient was extremely agitated and self abusive, requiring restraints and medication to decrease his agitation and self abusiveness. One of the tests administered during his hospital stay indicated that J.D. was a moderate risk for suicidal behavior. During his hospital stay, it was discovered that J.D. had threatened to kill himself while at school. He had been in a partial treatment program during the day, but that environment was not working. There was violence in the home, and J.D. was becoming overtly depressed. During his stay at the Hospital, J.D. was placed on close observation with 15-minute checks. His dosage of Prozac was increased. The admission and length-of-stay for J.D. were medically necessary. R.J., a 10 year-old male, was admitted to the Hospital on January 1, 1995, and discharged on February 9, 1995. The Agency denied Medicaid reimbursement based on a determination by KePro that the treatment in an acute care facility was not medically necessary because R.J. was not psychotic, not suicidal, and not a threat to others; thus treatment could have been provided in an alternate setting. R.J. had been referred by a health care professional at Horizon Center, an outpatient center, because of progressive deterioration over the previous fourteen months despite outpatient treatment. His deterioration included anger with temper outbursts, uncontrollable behavior at school, failing grades, sadness, depressed mood, extreme anxiety, extensive worrying and a fear of his grandmother. R.J. also suffered from encopresis, a bowel incontinence. He was agitated, lacked energy, neglected his hygiene, experienced crying spells, and had difficulty concentrating. R.J. needed to be admitted for an evaluation to rule out a paranoid psychosis. It was necessary to do a 24-hour EEG as opposed to a 45-minute EEG. In order to do a 24-hour EEG, the patient is typically placed in an acute care facility. The EEG showed abnormal discharge in the brain, which could be contributing to a psychiatric illness. At school R.J. had smeared feces on the walls, behavior that could be seen in psychotic persons. There was evidence that he had been hitting and throwing his stepbrother and 3 year-old brother. He was fearful of his grandmother and, based on his family history, there was reason to fear her. R.J. was placed on Buspar, a medication which generally takes two weeks to take effect. Contrary to the Agency's determination, R.J. was disorganized. He was also violent in terms of threatening danger and extreme anger. The admission and length-of-stay for R.J. at the Hospital were medically necessary. Patient C.A., a 9 year-old male, was admitted to the Hospital on June 1, 1995, and discharged on June 12, 1995. The Agency disallowed one day of the length-of-stay based on a determination by KePro that the services provided on June 11, 1995, could have been provided in a less restrictive setting. C.A. was admitted for violent and disruptive behavior. He also had an attention deficit, hyperactivity disorder and was taking Lithium and Depakote. These medications are used for patients who experience serious mood swings and abrupt changes in mood, going from depression to anger to euphoria. To be effective, medicating with Lithium and Depakote requires that the blood levels of the patient be monitored and the dosage titrated according to blood level. C.A. also was given Wellbutrin during his hospital stay. On June 11, 1995, C.A. was given an eight-hour pass to leave the hospital in the care of his mother. The physician's orders indicated that the pass was to determine how well C.A. did in a less restrictive setting. He returned to the Hospital without incident. He was discharged the next day to his mother. The treatment on June 11, 1995, could have been provided in an environment other than an acute facility; thus the stay on June 11, 1995, was not medically necessary for Medicaid reimbursement purposes. Patient G.M., an 11 year-old male with a history of being physically and sexually abused by his parents, was admitted to the Hospital on March 21, 1995, and was discharged on April 3, 1995. The Agency denied Medicaid reimbursement for inpatient hospital treatment from March 28 to April 3, 1995, based on KePro's determination that the length of hospital stay exceeded health care needs at an inpatient level and could have been provided in a less acute setting. At the time of admission, G.M. had suicidal ideation. His school had reported that G.M. had mutilated himself with a pencil, banged himself on the knuckles, and told the school nurse that he wanted to die. Prior to admission, G.M. had been taking Ritalin. His treating physician took G.M. off the Ritalin so that she could assess his condition and start another medication after a base-line period. The doctor prescribed Clonidine for G.M. Clonidine is a drug used in children to control reckless, agressive and angry behavior. Clonidine must be titrated in order to establish the correct dosage for the patient. During his hospital stay, G.M. was yelling and threatening staff. He was placed in locked seclusion, where he began hitting the wall. G.M. was put in a papoose, which is similar to a straitjacket. The papoose is used when there is no other way to control the patient. The patient cannot use his arms or legs while in a papoose. This type of behavior and confinement was occurring as late as March 31, 1995. G.M. was given a pass to go to his grandparents on April 2, 1995. He did well during his pass, and was discharged on April 3, 1995. Treatment in an acute facility was medically necessary through April 1, 1995. Treatment on April 2, 1995, could have been provided in a less acute setting. Patient S.S., a 5 year-old male, was admitted to the Hospital on March 9, 1995, and was discharged on April 3, 1995. The Agency denied Medicaid reimbursement for the admission and entire length of his hospital stay based on a determination by KePro that S.S. was not psychotic or an immediate danger to himself or others and the evaluation and treatment could have been rendered in a less acute setting. Prior to admission to the Hospital, S.S. was threatening suicide, ran into a chalk board at school, scratched his arms until they bled, and showed aggressive intent toward his sister, saying that he would kill her with a saw. S.S.'s condition had been deteriorating for approximately three months before his admission. At the time of admission, he had been suicidal, hyperactive, restless, and experiencing hallucinations. The hallucinations imply a psychosis. S.S. was put on Trofanil, an antidepressant which needs to be titrated. The patient's blood level had to be monitored while taking this drug. During his hospital stay, S.S. was on close observation. All objects which he could use to harm himself were removed from his possession. After he ate his meals, the hospital staff would immediately remove all eating utensils. On March 28, 1995, S.S. threatened to kill himself and became self-abusive. His blood level on March 31, 1995, was sub-therapeutic, and his medication dosage was increased. On April 1, 1995, S.S. had a temper tantrum. The admission and length-of-stay for the treatment of S.S. were medically necessary. Patient M.P., a 10 year-old male, was admitted to the Hospital on April 27, 1995, and was discharged on May 6, 1995. The Agency denied Medicaid reimbursement for the admission and entire length-of-stay based on a determination by KePro that the patient functions on an eighteen to twenty-four month level but is not psychotic and the treatment could have been provided in a less acute setting. M.P.'s IQ is between 44 and 51. He was diagnosed with a pervasive development disorder, which is a serious lack of development attributed to significant brain damage. His condition had deteriorated in the six months prior to his admission. He had episodes of inappropriate laughter, fits of anger, hit his head, hit windows, and put his arm in contact with the broken glass through the window. At the time of his admission, he had a seizure disorder. An EEG and an MRI needed to be performed on M.P. in order to evaluate his condition. M.P. had to have a regular EEG, a 24-hour EEG, and a neurological examination. The patient was aggressive, restless, and uncooperative. In order for the MRI to be performed, M.P. had to be anesthetized. The admission and length-of-stay for M.P. were medically necessary. Patient C.T., a 34 year-old female, was admitted to the Hospital on November 11, 1994, and was discharged on November 26, 1994. The Agency denied the treatment from November 17, 1994, to November 26, 1994, based on a determination by a peer review organization that the patient was stable by November 17, 1994, and psychiatric follow-up could have been performed in an outpatient setting. C.T. was admitted for kidney stones. She did pass the kidney stones but continued to have severe pain. Her doctor asked for a psychiatric consult. The psychiatrist diagnosed C.T. as having a personality disorder, chronic psychogenic pain disorder, and an eating disorder. Her depressive disorder exacerbated pain. C.T. had been given narcotics for the pain associated with the kidney stones. In order to assess her mental status, the physicians needed to taper the dosage of Demerol which she had been receiving. She was started on Sinequan, which is an anti-depressant given to alleviate the psychological condition and to help with the physical complaints. C.T. was later put on Vicodin, an oral narcotic, which seemed to bring the pain under control. The drugs used could cause a drop in blood pressure; therefore, they had to be titrated slowly. Her treating physician was trying to find an appropriate anti-depressant, while weaning the patient from intramuscular narcotics. On November 17, 1994, C.T. left her room and went to the hospital lobby, where she was found by nursing staff. C.T. was crying and saying that she was in pain and wanted to die. During her hospital stay, C.T. was in much distress; she would scream out that she was in pain. On November 18, 1994, she was found crying on the floor of the hospital chapel and had to be returned to her room. It was the opinion of Dr. Bernard Frankel, an expert retained by the Hospital, that C.T. probably could have been discharged a day earlier. The hospital stay for C.T. from November 17, 1994, to November 25, 1994, was medically necessary. The last day of her stay was not medically necessary.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered requiring Indian River Memorial Hospital, Inc., to pay to the Agency $752.14 for one day of service provided to G.M., $752.14 for one day of service provided to C.A., and $473.22 for one day of service provided to C.T. and finding that the Hospital is not liable for payment for any of the other services at issue in this proceeding. DONE AND ENTERED this 2nd day of November, 1998, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of November, 1998. COPIES FURNISHED: Thomas Falkinburg, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 John D. Buchanan, Jr., Esquire Henry, Buchanan, Hudson, Suber & Williams, P.A. 117 South Gadsden Street Tallahassee, Florida 32302 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 Paul J. Martin, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact Respondent Ahmed Elkadi, who holds a license to practice medicine in Florida, No. 0031490, was one of two surgeons (among some half dozen physicians) on the staff of Weems Memorial Hospital in Apalachicola, Florida, in August of 1988. Whether the physicians on staff who were not surgeons had other specialties and, if so, what they were, the proof did not show. A duly licensed 29-bed general hospital, Petitioner's Exhibit No. 7, Weems Memorial had, "on a . . . stat basis," (Fitzgerald Deposition at 13), despite its small size, "24-hour respiratory therapy capability, 24-hour laboratory coverage, [and] 24-hour radiology coverage," (Fitzgerald Deposition at 5), which did not, however, include computed tomographic scanning or magnetic resonance imaging technology, both available only at facilities some 60 or 70 miles away. Continuous cardiac monitoring was available in house. Id. at 16. Weems Memorial had a physician in house 24 hours a day and a registered nurse on duty 24 hours a day, along with "at least one LPN," (Fitzgerald Deposition at 6), and two nurse's aides. Id. On average, Weems Memorial only had five or six inpatients at any one time during 1988. Staff off premises but on call were required to report within 30 minutes of being summoned. Fitzgerald Deposition at 13. On August 22, 1988, Dr. Elkadi admitted A. L. as a patient, in preparation for gastric bypass surgery the following day. A 29-year-old woman, A. L. (who worked as a nurse at the hospital) stood 5 feet 1.5 inches tall and weighed 303 pounds, when admitted. A chest x-ray taken before she was admitted uncovered no abnormalities other than obesity. Because she "was in excess of twice her standard weight for height," (MacGregor Deposition, p.7) and had "blood cholesterol elevation and [elevated levels of] blood triglycerides," Id., p.8, and because of her age, A. L. was an appropriate candidate for gastric bypass surgery, Corwin Deposition. She signed a form consenting to the operation. Roux-en-Y Dr. Elkadi performed the surgery, a "gastric bypass with Roux-en-y gastrojejunostomy," Petitioner, Exhibit No. 2, p. 7, on August 23, 1988. A. L., who was anxious about the impending operation, received Valium as well as anesthesia before the procedure began. While A. L. lay on her back anesthetized, he cut open her abdomen and partitioned her stomach with staples, thus reducing the capacity of her stomach to receive food; and joined the small, newly segregated, upper portion of her stomach directly to the small intestine. In a contemporaneous operative note, Dr. Elkadi described the procedure: . . . . The TA 90 stapler was used twice to proximal gastric from the proximal apply a double staple line across the stomach to separate a small proximal pouch with a capacity of about 30 cc remaining stomach cavity. A loop of in side using inner for was jejunal completed. 14 the the jejunum was pulled up through an opening the transverse mesocolon and anastomosed to side to the proximal gastric pouch a running suture of 3-0 chromic for the layer and interrupted 3-0 silk sutures the outer layer. A naso-gastric tube passed into the distal limb of the loop before the anastomosis was The gastrojejunostomy measured about 12- mm in diameter. The proximal limb of jejunal loop was then disconnected just proximal to the gastrojejunostomy using GIA stapler, and the cut end was anastomosed to the distal limb about 60 cm distal to the also gastrojejunostomy. The GIA stapler was used for the entero-enterostomy supported by a running 3-0 silk suture for the serosal transverse loop layer. The edges of the opening of the mesocolon were sutured to the jejunal . The using a fascia, a of using interrupted 3-0 silk sutures. . . abdominal wall was closed in layers running suture of #1 Dexon for the running suture of #3-0 Dexon for the subcutaneous layer, and a running suture #3-0 Nylon for the skin. . . . Petitioner's Exhibit No. 2. As reported and as is customary, Dr. Elkadi severed the small intestine just above the newly fashioned connection to the "small proximal gastric pouch." Because gastric juices continue to leave the distal stomach and travel through the disconnected intestinal segment, the procedure was not complete until this segment of the jejunum was rejoined to the small intestine lower down. In manipulating the jejunum to accomplish the reconnection, it was necessary to cut and tie off various blood vessels, including tributaries of the mesenteric vein. Dr. MacGregor, one of petitioner's expert witnesses, testified that "[t]he record indicates that [the surgery] was done appropriately." T.15. On deposition, petitioner's counsel asked and Dr. MacGregor answered: Q. It seems to be a normal surgery? A. Right. Q. Except for the amount of time? A. Correct MacGregor deposition 15. The operation took four hours. The other surgeon petitioner called as an expert testified that "probably four hours would be a reasonable time." Corwin Deposition at 12. Petitioner produced no witness who testified that respondent's work in the operating room failed to meet standards of any kind. Sequelae In the wake of operations of this kind, "mortality can be as high as 2.7 to 2.9 per cent at training centers who have documented teams of specialists and post op care specialists." T.15. Complications "tend to be in two major groups . . . pulmonary embolism and infections." Id. The "most important complication of gastric bypass surgery is perforation or leakage," (MacGregor Deposition at 16) which leads to infection. In many hospitals, nursing administration routinely assigns a formal nursing plan for postoperative patients, after consulting with the surgeon. MacGregor Deposition at 15. But practices vary (Corwin Deposition at 13) and the omission of a formal nursing plan altogether "in and of itself . . . is not unusual," (Fitzgerald Deposition at 12) at least in smaller hospitals. No formal, written nursing or contingency plan was drawn up for A. L. Dr. Elkadi did not originally direct care for A. L. "beyond what [staff] would normally do [for] any postoperative surgical patient." Fitzgerald Deposition at 11. A. L. left the operating room at ten before two on the afternoon of August 23, 1988. An hour and 40 minutes later, her pulse rate was 84 and her respiration was 28. Petitioner's Exhibit NO. 2. At ten o'clock that night, her pulse was 112 and her respiration was 36; and, at or about the same time, her temperature was approximately 97.2o F. A half hour later, with Dr. Elkadi present, A. L. was standing by her bedside and taking a few steps. The next morning she sat up, first on the side of her bed, then in a chair. At half past one on August 24, 1988, she walked to the nursing station, which she "tolerated well." But, after she returned to her bed, she complained of "surgical pain." At six o'clock that evening she walked a short distance in the hall, returned to her room, sat in a chair and, after she had gone back to bed, again complained of "surgical pain." A chest x-ray taken the day after the operation revealed "[s]mall areas of linear atelectasis . . . in the lung bases," Petitioner's Exhibit No. 2, p. 43, which a radiologist attributed to A. L.'s not having taken a full breath. He found that a "full inspiration was not taken during filming," Id., and that the atelectasis was "probably for this reason." Id. On the evening of August 24, 1988, the nursing notes reported "slight drainage of dark green fluid" from the nasogastric tube. Earlier that day, bloody drainage ("scant") was reported for what may have been the first and only time. The last entry in the nurse's notes characterized the drainage as dark brown; "scant amt greenish drainage," Petitioner's Exhibit No. 2, was reported as late as four o'clock on August 26, 1988. Also at four o'clock on the afternoon of August 26, 1988, the nurse's notes reported, "Bowel sounds [were] audible in all 4 quadrants." Petitioner's Exhibit NO. 2. At seven o'clock that evening, according to the same source, A. L. "had small tan colored lo[ose] stool." Id. A blood specimen drawn at nine o'clock on the morning of August 26, 1988, yielded a "WBC" test result of "19.9." Id. at an unnumbered page. The white blood cell count had "c[o]me down to 11,000 on the day of [A. L.'s] admission." Petitioner's Exhibit No. 2, p. 7. On the morning of August 25, 1988, another walk in the hall ended with A. L.'s sitting in a chair. The nurses' notes reported that she was "[t]olerating activity well." Petitioner's Exhibit No. 2. At eleven o'clock that night, "belching incessantly," she complained of back and stomach pain, and a nurse helped her take a walk. She was still up (sitting in a chair) at midnight, when a second walk resulted in "much relief in stomach." Pain and belching persisted, nevertheless, and Dr. Elkadi was called, arriving at ten before one o'clock in the early morning of August 26, 1988. After seeing A. L., respondent ordered an enema and a dose of Vistaril. At quarter past one, she was pushing on her stomach to relieve gas pains. The nurses' notes reported that she was "extremely anxious," and Dr. Elkadi prescribed five milligrams of Valium. She continued to belch, and Dr. Elkadi was notified of her distress and anxiety at three o'clock in the morning. After she received another five milligrams of Valium (presumably at Dr. Elkadi's behest), she fell asleep. At 5:20 that morning, she was given a third five milligram dose of Valium, and at seven o'clock three milligrams more. In each instance, it was administered intravenously by "slow push." Awake by seven, when she complained of abdominal pain, she was given two milligrams of Levodromoran, after walking to and from the nursing station. When the respiratory therapist saw her at nine o'clock, she was sitting in a chair, again complaining of abdominal pain. But an hour later, when she went to the shower, she said she had less gas pain. That afternoon, she rested in bed, sat in a chair, and walked in the hall. The day after the operation, A. L.'s temperature had risen to 100.5o F., and her pulse had reached 128. When her pulse declined on the following day, August 25, 1988, her temperature remained elevated. On August 26, however, her temperature dropped to normal and her pulse leveled off at the low to mid 90s. On August 23, 1988, the day of the surgery, and again on each of the two following days, Dr. Elkadi ordered extra intravenous fluids. On more than one occasion, the nurse's notes reported that intravenous solution was infusing with difficulty, or words to that effect. While a 1500-milliliter per day discrepancy between fluid intake and urine output is to be expected, the discrepancy averaged some 3500 milliliters per day in A. L.'s case, following her surgery. After surgery, she was given morphine in five-milligram doses, intravenously, as needed. The day after the operation, A. L. also received Levodromoran for pain. On August 25, 1988, although she again received both pain-killing medications, she required less morphine. On August 26, 1988, however, in response to complaints of pain, the amounts both of morphine and of Levodromoran she received increased over the previous day's totals. Dr. Elkadi also prescribed Valium and Vistaril; and A. L. received a total of 100 milligrams of the latter, on August 26, 1988, in multiple doses. In addition, Dr. Elkadi prescribed and A. L. received Nubain, an analgesic that, according to Dr. MacGregor, "is a narcotic antagonist." Petitioner's Exhibit No. 1 to MacGregor Deposition. It is therefore possible that Nubain offset the increased dosages of narcotics in whole or in part. The Last Day A. L. awoke at half past six on the morning of August 27, 1988, complained of pain, and received an injection of Nubain. Only 30 minutes later, she complained of "pain between shoulders," but she received no more pain medication, according to the nurse's notes, until five after two that afternoon, when she was given an injection of five milligrams of Valium. (Twelve hours earlier, she had received ten milligrams of Valium.) At seven o'clock on the morning of August 27, 1988, the nurse's notes again reported "good bowel sounds heard in all quad." Id. Early that afternoon, after an enema, according to the nurse's notes, "pt had good results of flatus & sm amt of lg stool." Id. At four o'clock, she "passed some flatus." Id. At quarter of eight that morning, and again at nine, A. L. used a spirometer. Dr. Solman saw her at eight o'clock. She complained of shortness of breath at nine. A chest x-ray taken August 27, 1988, showed "areas of atelectasis in each lung base, somewhat more pronounced on the right side." Id. at 44. At three o'clock that afternoon, she was hyperventilating. When Dr. Loutfi saw her at half past three, her lungs were clear, and the X-ray taken earlier in the day had evidently not yet been seen by a radiologist. At half past four, a nurse gave A. L. ten milligrams of Valium "for relaxation/rest," Petitioner's Exhibit No. 2, and, fifteen minutes later, a "bag to breathe in," which A. L. used for about five minutes. The nurse initialled A. L.'s chart next to a physician's order that concluded: "Valium 10 mg. IV slowly." Petitioner's Exhibit No. 2. Asked on deposition who ordered the Valium, Dr. Corwin testified: And then it says. I can't read what it says. record to Loutfi in far as NAR? I don't know. DR. ELKADI: Dr. Ludwig [sic]. BY DR. ELKADI: Q. All right. In patients having - - MRS. SMALL: I would object for the the questioner testifying. Corwin Deposition at 42. Perhaps Dr. ordered the Valium. The order was not, any event, given by the respondent, as the evidence shows. At quarter past five, the nurse "encouraged [A. L.] to slow/deep breathe." Id. Ten minutes later she found A. L., whom she had last seen sitting on the side of her bed, sprawled across it. Cyanotic around the mouth, she was not breathing. After Drs. Loutfi and Elkadi tried in vain to resuscitate A. L., respondent pronounced her dead, at 6:30 p.m. on August 27, 1988. Cause of Death Unclear Each of the four physicians who testified at hearing or on deposition assigned a different reason for A. L.'s death. Dr. Elkadi reported the following in a discharge summary: The postoperative course during the first 4 occasional the blood of be Patient the The was patient was days was uneventful except for episodes of anxiety, usually related to incisional pain or discomfort caused by NG-tube, and which always responded to sedation or analgesis medication. The oxygenation was measured during several these anxiety episodes and was found to satisfactory with 02 saturation level of 95-97% using the finger tip oxymeter. was walking outside the room already on first postoperative day. By the fourth postoperative day the Foley catheter was removed and she had 2 bowel movements. incision was healing well, and the chest clear to auscultation. On 8/27/88, about 5:20 p.m., the suddenly arrested, and cardiopulmonary resuscitation was carried out. There heart to over an The of considerable airway resistance, and the was in asystole which failed to respond large doses of cardiac drugs. After hour of intensive resuscitative efforts, patient was pronounced dead at 6:30 p.m. course of events was strongly suggestive massive pulmonary embolism. Petitioner's Exhibit No. 2. After the autopsy revealed that the only blood clots in the lungs had formed post mortem, Dr. Elkadi refined his hypothesis, and posited a fat embolus or emboli in the lungs, which, he surmised, degraded into free fatty acids before the autopsy took place, perhaps before death occurred. He testified that free fatty acids produce serotonin, which causes bronchospasms, and he cited resistance the airway offered during the unsuccessful attempt to resuscitate A. L. Ventilation and oxygenation were virtually impossible, even though the endotracheal tube was already in place. Although Dr. Mahoney, the pathologist who performed the autopsy, found a fatty liver, he ruled out a pulmonary fat embolism because he saw no evidence of infection or trauma to the liver (which might have dislodged fat) and because examination of lung and brain tissue (a single section of each) revealed no fat globules. "No intravascular lipid vacuoles were identified in the lung." Petitioner's Exhibit No. 2. On the other hand, "[o]ccasional perivascular lipid vacuoles were seen . . . in the brain section . . . ," Id., indicating fat cells must have passed through the lungs at some point. The autopsy report made no mention of any mechanical blockage or of distension of any part of the gastrointestinal track. Nor was there evidence of alimentary leakage. All sutures held. "Inspection [during the autopsy] of the surgical sites where the surgeon had done anastomotic, reanastomosis of stomach and bowel . . . [showed] these sites were intact and grossly appeared viable." T. 9. Dr. Mahoney listed as a major finding in the autopsy report "[i]schemic enteritis with focal necrosis of the proximal jejunal segment at the entero-enterostomy junction of the Roux-en-y procedure; mesenteric vein thrombosis." Petitioner's Exhibit No. 2. But at hearing he testified, consistently with reported results of microscopic examination, that "major findings at the autopsy . . . [included] a segment of intestine, the jejunal segment, which had undergone a hemorrhagic necrosis." T. 8. Ischemic changes occur when blood supply is insufficient, while hemorrhagic changes are the result of insufficient ability to remove blood. Blood clots blocked veins serving the necrotic tissue. At hearing, Dr. Mahoney concluded "that the most probable cause [of A. L.'s death] was this dead bowel segment essentially causing sepsis." T. 13. Microorganisms penetrating the transmural necrosis caused localized infection outside the bowel or peritonitis, he testified, which led to infection in the blood stream. Septic toxins circulating in the blood caused cardiovascular failure, he theorized. These conclusions rest on autopsy findings of serositis and "approximately 1 liter of cloudy brown fluid with fibrin strands," (Petitioner's Exhibit No. 2) in the abdominal cavity. But Dr. Mahoney did not find "certain types of cells" (T.94) usually found two and a half to three days after peritonitis sets in. In fact, the autopsy findings "are not unusual findings after abdominal surgery without any complication." T.130. Dr. Corwin, one of two surgeons testifying as experts for petitioner, testified that "the autopsy report . . . [contained] essentially no indication of peritonitis." Corwin Deposition at 46. In a report petitioner put in evidence, Dr. Corwin had earlier written that "there really is no evidence of peritonitis." Dr. Corwin wrote, on June 25, 1990, after examining A. L.'s records, "In my opinion the heavy dose of intravenous Valium within the hour before the patient's sudden cardiac arrest almost certainly caused apnea, respiratory shutdown and subsequent to this, the patient suffered a cardiac arrest from which she could not be resuscitated." Petitioner's Exhibit No. 3. Dr. Mahoney testified that the final administration of Valium "may have actually contributed to a respiratory arrest" (T.15) and so to A. L.'s death. A. L. received her last dose of valium 45 minutes before she was last seen alive and 55 minutes before she was found dead. Dr. Corwin conceded that he had ordered Valium for patients in circumstances comparable to A. L.'s over a period of some 17 years, but always, he said, in situations where the patient would be watched, until the effects of the drug wore off. When administered intravenously, Valium has its maximum effect within five minutes. As far as the evidence showed, A. L. did not have an adverse effect to any earlier dose of Valium. For moderate anxiety, the Physicians' Desk Reference (1987 ed.) recommends dosages of "2 mg to 5 mg, I. M. or I. V. Repeat in 3 to 4 hours, if necessary." For severe anxiety, the same reference recommends dosages of "5 mg to 10 mg, I. M. or I. V. Repeat in 3 to 4 hours, if necessary." "Valium is indicated for the management of . . . short-term relief of the symptoms of anxiety." Respondent's Exhibit No. 2. Contraindications are "known hypersensitivity" and glaucoma. Dr. MacGregor, the other surgeon whose opinion petitioner relied on, testified that the "fundamental cause [of A. L.'s death was hypovolemic shock . . . [shock brought on by l]ow blood volume." MacGregor Deposition at 30. When asked, Dr. MacGregor agreed that Valium "may have contributed," id. at 29, to A. L.'s death. But his principal contention was that the focal necrosis created an ileus or physiological obstruction, which caused distension of the stomach and upper gastrointestinal tract which in turn led to a loss of fluid into the lining of the stomach and bowel and ultimately to hypovolemic shock. Recordkeeping Petitioner presented evidence from the same two surgeons on the question whether respondent had adequate medical records while treating A. L. In a letter attached to Dr. Corwin's deposition as an exhibit, he wrote: Did the subject prepare and keep written medical records justifying the course of treatment of the patient, including history, examination and test results? The answer to this question is yes. Deposition of Corwin, Petitioner's Exhibit No. 3. Dr. MacGregor testified that respondent's operative note was "inadequate in terms of . . . [d]etails of sutures and the techniques that were used . . . the instruments used . . . not the number of sutures but the type of sutures and the number of layers." Deposition of MacGregor at 12. But on cross-examination, Dr. MacGregor conceded that "similar operative notes [are] found in many other surgeons' records." Deposition of MacGregor at 35. The hospital records contain a separate, presumably complete list of the surgical instruments Dr. Elkadi used. Although Dr. Elkadi ordered arterial blood gas evaluations, and blood tests specifically to determine oxygen saturation, results of these tests are not in the hospital records, insofar as the hearing officer could discover. Dr. MacGregor testified the results were not in the copy of the records he was furnished. He testified: I think a blood gas was obtained but it's not two helpful normal in the records; and oxygen saturation on occasions. . . . [T]hey would be quite because they might well indicate fairly levels in a patient who has a rapid respiratory rate . . . Deposition of MacGregor at 24. Dr. MacGregor testified that he "would have thought that [it] would have been standard hospital procedure for whoever obtained those, to have recorded them in the record." Deposition of MacGregor at 25.
Recommendation It is, accordingly, RECOMMENDED: That petitioner dismiss the administrative complaint against respondent. DONE and ENTERED this 25th day of January, 1991, in Tallahassee, Florida. Administrative Hearings 1550 the Administrative Hearings 1991. ROBERT T. BENTON, II Hearing Officer Division of The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399- (904) 488-9675 Filed with the Clerk of Division of this 28th day of January, APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact Nos. 1 through 7, 12, 14, 15, 16, 18, 20, 21, 22 and 28 have been adopted, in substance, insofar as material. With respect to petitioner's proposed findings of fact Nos. 8 and 9, see paragraphs 11 through 28 of the findings of fact. With respect to petitioner's proposed findings fact No. 10, the record showed dosages, before the final dose, of five, five, five, three, ten and five milligrams. With respect to petitioner's proposed finding of fact No. 11, some tests were done; others were not. Petitioner's proposed findings of fact Nos. 13, 19, 23, 24, and 26 pertain to subordinate matters. With respect to petitioner's proposed findings of fact Nos. 17 and 25, the cause of death was not clear. Petitioner's proposed findings of fact Nos. 27 and 29 were not proven. Petitioner's proposed findings of fact No. 31 is immaterial. Respondent's proposed findings of fact Nos. 1, 2 and 3 in Part 1 and 3 in Part 2, have been accepted, in substance, insofar as material. With respect to respondent's proposed finding of fact No. 4 in Part 1 and No. 10 in Part 3, these matters are not material to the allegations of the administrative complaint. With respect to respondent's proposed finding of fact No. 5 in Part 1 and Part 2, the cause of death is unclear. With respect to respondent's proposed findings of fact Nos. 1, 2 and 8 in Part 3, see findings of fact Nos. 11 through 28. With respect to respondent's proposed finding of fact No. 4 in Part 3, the autopsy report does not reflect this but he so testified at hearing. Respondent's proposed findings of fact Nos. 5, 6, 7 and 9 pertain to subordinate matters. COPIES FURNISHED: Wellington H. Meffert, II, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Ahmed Elkadi, M.D. 236 S. Tyndall Parkway Panama City, FL 32404 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact The Parties FRTC is a wholly-owned subsidiary of Charter Medical Corporation (Charter) which proposes to construct and operate a freestanding, 60 bed, 24- hour-a-day, Intensive Residential Treatment Program for children between the ages of 6 and 18 in Palm Beach County within HRS District IX, pursuant to Rule 10-28.152(8), F.A.C. and Chapter 395, F.S. Although FRTC represents it will construct its proposed facility with or without CON licensure, which it is entitled to do, given the peculiarities of this type of health care entity, it is clear that a prime motivator in FRTC's CON application is that with CON licensure, FRTC potentially will have greater access to insurance reimbursement because it may then call itself a "hospital." FRTC will seek JCAH accreditation. HRS is the state agency with the authority and responsibility to consider CON applications, pursuant to Chapter 10-5.011, F.A.C. and Sections 381.701-381.715, F.S. (1987). HRS preliminarily approved FRTC's application, and supported it through formal hearing and post-hearing proposals. RTCPB is an existing 40 bed residential treatment center for adolescents between the ages of 12 and 18, located in Palm Beach County, on the campus of Lake Hospital of the Palm Beaches. It provides services similar or identical to those services proposed to be offered by FRTC. It is JCAH accredited through an extension of Lake Hospital's accreditation and is close to JCAH accreditation in its own right. RTCPB is a subsidiary of Psychiatric Hospitals, Inc. (PIA) . PIA operates two residential treatment centers in Florida. RTCPB is not CON licensed as an IRTP, under Chapters 381 and 395, F.S., but is licensed as a child care facility under Chapter 395, F.S., as a provider of services to HRS under Chapters 10M-9 and 10E-10, F.A.C. RTCPB accepts substance abusers in residency. RTCPB has also applied for CON licensure as an IRTP in a batching cycle subsequent to the present one. That application has been preliminarily denied by HRS and RTCPB is awaiting a Section 120.57(1), F.S., formal administrative hearing thereon. RTCPB now estimates its current patients' average length of stay (ALOS) as 106 days but projects a 315 day (10 1/2 months) ALOS in its subsequent CON application. RTCPB is charging $185 per day or HRS patients and $255 with $23-26 ancillaries [sic] per day for private pay patients. Like FRTC, it uses a "levels" system of behavior modification and patient control. Humana is a 250 bed JCAH accredited hospital located in Palm Beach County, Florida. Of Humana's 250 beds, 162 are traditional acute care beds and 88 are psychiatric beds. The 88 psychiatric beds are administratively divided into different units, one of which is a 27 bed adolescent psychiatric unit; this unit opened January 20, 1987, and has an average length of stay of nine months. Humana's existing CONs are for short-term adult psychiatric beds and do not authorize an adolescent unit with an average length of stay of over 30 days. Ninety days is the demarcation, by rule, between short- and long-term psychiatric beds. Humana recently applied for a CON for more psychiatric beds and also applied for an IRTP CON in a subsequent batch to the present one. Humana's present 27 bed adolescent psychiatric unit provides grossly similar services to those proposed to be offered by FRTC, but its emphasis is more medical-psychiatric than emotional-behavioral. Like FRTC, Humana does not accept in residency adolescents with a primary diagnosis of substance abuse. Like FRTC and RTCPB, Humana uses a "levels" system. Eighty percent of Humana's patient mix are commercial pay, and the unit is running at a 15 to 20 percent profit margin. Humana usually charges $325 per day on their adolescent unit plus ancillaries [sic] amounting to 10 percent of the patient's bill, but HRS contract patients pay only $225 per day. Humana has lost a number of adolescent unit referrals to RTCPB since RTCPB opened June 1, 1987, but the unit continues to be almost fully occupied. Humana's main referral asset, as well as the source of the confusion of referring entities, appears to be the reputation of its director, Dr. Kelly. Dr. Kelly previously directed a program at Lake Hospital which was identical to the program that he now directs at Humana. Lake Hospital currently has RTCPB operating under its auspices, but not Dr. Kelly. Nature of the FRTC Program FRTC's proposed program is designed to serve those persons in the designated age group who have psychiatric diagnoses of a severity requiring a long-term approach in a multidisciplinary structured living setting to facilitate recovery. It will not, however, treat adolescents with an active diagnosis of chemical dependency or substance abuse. It also only commits to 1.5 percent indigent care. The proposed FRTC program differs from an acute care setting in significant quantitative and qualitative ways, the most visible of which is that acute care psychiatric settings (either long- or short-term) are geared toward dealing with patients actively dangerous to property, themselves, or others, but patients whom it is reasonably assumed will respond primarily to physiologically-oriented physicians and registered nurses administering daily medication, treatment, and monitoring, as opposed to a long-term living arrangement emphasizing behaviorally-oriented group interaction as an alternative to parental care at home. FRTC will, however, accept patients with psychiatric diagnoses of effective disorders, depression, schizophrenia and impulse disorders and those who may be potentially harmful to themselves, others, or property for whom no other less intensive or less restrictive form of treatment would be predictably helpful. FRTC would fall on the continuum of care below an acute psychiatric facility such as Humana. Assessment of such a target group on a patient by patient basis is obviously subject to a wide variation of interpretation by qualified health care professionals, but FRTC anticipates both verifying referral diagnoses and assuring quality of care by insuring that each new patient is seen by a psychiatrist within 24 hours of admission, and by having each case reviewed by an independent utilization review committee. FRTC also plans to complete appropriate patient assessments and develop and update individual, integrated treatment programs. FRTC will provide, where appropriate, for continuity of care from previous acute care institutions through the FRTC program and out into more normal individual or family living arrangements. Parents will have to consent to their child's placement at FRTC. FRTC's program proposes an average length of stay of 365 days (one year) with a range of six months to two years. Based upon all the credible record evidence as a whole, including, but not limited to, the protestants' respective ALOS, this is a reasonable forecast despite contrary evidence as to Charter's experience at its "template" Virginia institution, Charter Colonial. FRTC's program components will include individual therapy, recreational therapy, occupational therapy, and general education. The general education component in FRTC's proposed program is more general and more open than that offered in acute care settings, such as Humana. FRTC's overall program will utilize a "levels" system of behavioral management based upon patients earning privileges, which levels system has a good patient rehabilitation and functional administrative track record in many different kinds of psychiatric health care facilities, including Humana and RTCPB. FRTC intends that each patient's program will be individualized according to age and program component directed to his/her diagnosis and each patient will receive individual, resident group, and family therapies. As to assessment, types of therapy, continuity of care, and general education provisions, FRTC's proposal is grossly consistent with that of its "template." To the extent there is evidence of inconsistencies between the two programs in the record, the FRTC proposal represents either improvements over, or refinements of, its template program which have been developed as Charter/FRTC has learned more about what actually "works" for the IRTP form of health care, or it represents changes to accommodate Florida's perception of what less restrictive but still intensive residential treatment should be, or it anticipates local community needs. Quality of Care The applicant's parent corporation is an experienced provider of many types of accredited psychiatric facilities. The type of quality assurance program proposed and the staff mix provide reasonable quality care assurances. Design, Construction, and Personnel Refinements to FRTC's original schematic take into consideration the influence that physical structure has on an Intensive Residential Treatment Program. Those refinements include modification of a multipurpose room into a half-court gymnasium, addition of a classroom, addition of a mechanical room, modification of the nursing station to decrease the amount of space, and the deletion of one seclusion room and addition of a four to six bed assessment unit. The modifications resulted in the addition of approximately 1,000 square feet to the original design. A minimum of four to six acres would be necessary to accommodate the modified design which totals approximately 32,000 square feet. Public areas, such as administration and support services, dining room, and housekeeping areas, are to the front; private areas, such as the nursing units, are to the back. The facility's middle area houses gym, classrooms, and occupational therapy areas. The location encourages residential community involvement. Each of three, 20-bed units is made up of a group of two consultation rooms, a galley, a laundry, a day room and core living space located directly across from the nursing station for maximum observation and efficiency. Each unit comprises a separate wing. Six handicapped accessible patient beds are contemplated; the building will be handicapped-accessible. The staffing projections have increased and the pattern has been minimally altered in the updates. The updated pro forma also modified the initial financial projections so as to increase salary expense and employee benefits based on this change in staffing. An increase in the total project cost impacted on depreciation, and interest expense changed with time. All these changes are reasonable and insubstantial. FRTC's design is adequate for providing a suitable environment for intensive residential treatment for children and adolescents even though it is not identical to Charter's "template" for residential treatment and even though Charter's extensive experience with acute care facilities has focused these changes in its residential treatment concepts. The parties stipulated to the adequacy of FRTC's proposed equipment list and costs. Total construction cost was demonstrated to be reasonably estimated at $2,078,000. The square footage costs of $64.86 per square foot represet an increase from the square footage costs contained in the original CON application. The original budget was updated based upon a three percent inflation factor and the addition of the approximately 1,000 square feet. The additional space is not a significant construction change. The total project costs of $4,728,000 are reasonable. The testimony of HRS Deputy Assistant Secretary for Regulation and Health Facilities, John Griffin, who testified by deposition, (RTCPB's Exhibit 8, pp. 21-22) revealed no firm policy on what the agency, within its expertise, views as substantial and impermissible amendments to a CON application; HRS did not move at hearing to remand for further review; and the undersigned concludes that the changes in facility design, costs, and staffing do not represent significant changes which would be excludable as evidence and that they do represent permissible minor modifications and refinements of the original FRTC application. Site Availability No party contended that FRTC's application was a "site specific" application, that a residential treatment program is otherwise required to be "site specific," or that an IRTP CON is governed by a "site specific" rule or by "site specific" statutory criteria. Therefore, it was only necessary for FRTC in this noncomparative proceeding to establish that several suitable sites were available within the required geographic parameters at the financial amount allotted in FRTC's projections. FRTC did establish financially and geographically available and suitable sites through the testimony of Robert H. Ellzey, a qualified expert in commercial real estate values. The Non-Rule Need Policy There are no hospital licensed Intensive Residential Treatment Programs in Palm Beach County or in District IX. IRTPs are in a separate licensure category by law from psychiatric beds, acute care beds, and rehabilitation beds. There is a separate need methodology for long-term psychiatric beds and there are no CON licensed long-term psychiatric programs for children and adolescents in District IX, unless one considers Humana which is treating adolescents well beyond 30 or 90 days residency. HRS has no promulgated rule predicting need for IRTPs seeking specialty hospital licensure under Chapter 395, F.S. Subsequent to advice of its counsel that a CON must be obtained as a condition of IRTP licensure pursuant to Chapter 395, F.S., HRS elected to evaluate all IRTP CON applications in the context of the statutory criteria of Chapter 381, F.S., and in the context of HRS' non-rule policy establishing a rebuttable presumption of need for one "reasonably sized" IRTP in each HRS planning district. The May 5, 1988 Final Order in Florida Psychiatric Centers v. HRS, et al., DOAH Case No. 88- 0008R, held this non-rule policy invalid as a rule due to HRS' failure to promulgate it pursuant to Section 120.54, F.S., but that order also held the policy not to be invalid as contrary to Chapter 381, F.S. That Final Order intervened between the close of final hearing in the instant case and entry of the instant Recommended Order, however, it does not alter the need for the agency to explicate and demonstrate the reasonableness of its non-rule policy on a case by case basis. HRS was unable to do so in the formal hearing in the instant case. Notwithstanding the oral testimony of Robert May and Elizabeth Dudek, and the deposition testimony of John Griffin, it appears that the non- rule policy is not based upon generally recognized health planning considerations, but solely on the agency's statutory interpretation of recent amendments to Chapter 395 and some vague perception, after internal agency discussions, that the policy is consistent with certain promulgated need rules and with certain other non-rule policies for other types of health care entities, which other non-rule policies were never fully enunciated or proved up in this formal hearing. The HRS non-rule policy was also not affirmatively demonstrated to be rational because it does not take into account the reasonableness of a proposed facility's average length of stay, referral sources, geographic access, or other factors common to duly promulgated CON rules. Numerical Need and Conformity to Applicable Health Plans FRTC sought to support HRS' non-rule policy on numerical need for, and definition of, a "reasonably sized" IRTP through the testimony of Dr. Ronald Luke, who was qualified as an expert in health planning, development of need methodologies, health economies, survey research, and development of mental health programs. In the absence of a finding of a rational non-rule policy on numerical need, Dr. Luke's evidence forms the cornerstone of FRTC's demonstration of numerical need. Through the report and testimony of Dr. Luke, and despite contrary expert health planning testimony, FRTC established the numerical need for, and reasonableness of, its 60 licensed IRTP beds in District IX with projected 60 percent occupancy in the first year and 50 percent in the second year of operation using two bed need methodologies. Dr. Luke ultimately relied on a utilization methodology based upon 1991 population projections. Dr. Luke used a census rate per 100,000 population of 21.58. This is appropriately and reasonably derived from national data for residential treatment patients aged 0-17, regardless of the fact that the types of residential treatment considered by the NIMH data base employed by Dr. Luke greatly vary in concept and despite HRS having not yet clearly defined the nature of the programs and services it expects to be offered by a Florida specialty hospital licensed IRTP. Therefrom, Dr. Luke derived an average daily census of 52 in 1991. That figure yields a bed sizing of between 58 and 61 beds, depending on whether an 85 percent or 90 percent occupancy factor is plugged in. Either 58 or 61 beds is within the range of ratios calculated by Dr. Luke's other methodology for currently licensed Florida IRTPs in other districts. Assuming a target occupancy rate of 85 percent and an ALOS of one year, Dr. Luke considered the gross District IX IRTP bed need to be 60. In the absence of any like program to assess occupancy for and in the presence of similar programs such as Humana operating at nearly full occupancy now and RTCPB forecasting its occupancy at 88 percent in 1990 if it were IRTP-licensed, it is found that 60 beds are justified. Since there are no IRTP beds licensed as specialty hospitals in the current district bed inventory, no adjustment of this figure must be made to account for existing licensed IRTP beds. Simply stated, this is a CON application for an IRTP, nothing more and nothing less, and the subtrahend to be subtracted from gross district bed need is zero when there is a zero specialty hospital licensed IRTP bed inventory. Luke's calculated gross need of 60 bed is also his net need and is accepted. Fifty beds is generally the minimum size HRS will approve to be feasible for any free standing facility to be eonomically efficient and to be able to benefit from economies of scale. This 50 bed concept is within the wide range of bed ratios that HRS implicitly has found reasonable in, previously- licensed IRTP CON approvals. Conformity With Applicable Health Plans Section 38l.705(1)(a), F.S., requires HRS to consider CON applications against criteria contained in the applicable State and District Health Plans. In this regard, neither the applicable State Health Plan nor the applicable District IX Local Health Plan make any reference to a need for intensive residential treatment facilities. The District IX Health Plan addresses the need for psychiatric and substance abuse services to be available to all individuals in District IX. FRTC's project addresses this goal only in part. The District Health Plan states that priority should be given to CON applicants who make a commitment to providing indigent care. FRTC proposes only 1.5 percent indigent care which works out to only 1/2 of the ALOS of one patient at the proposed facility and is hardly optimum, but in a noncomparative hearing, it stands alone as advancing the given accessibility goal within the plan. Objective 1.3 of the State Health Plan provides: Through 1987, additional long-term inpatient psychiatric beds should not normally be approved unless the average annual occupancy for all existing and approved long-term hospital psychiatric beds in the HRS District is at least 80 percent. FRTC's project is neutral as to this goal. The District Plan also contains a goal for a complete range of health care services for the population of the district. FRTC advances this goal. The State Health Plan further provides: Goal 10: DEVELOP A COMPLETE RANGE OF ESSENTIAL PUBLIC MENTAL HEALTH SERVICES IN EACH HRS DISTRICT OBJECTIVE 10.1: Develop a range of essential mental health services in each HRS district by 1989. OBJECTIVE 10.3: Develop a network of residential treatment settings for Florida's severely emotionally disturbed children by 1990. RECOMMENDED ACTION: 1.03A: Develop residential placements within Florida for all SED children currently receiving ing treatment in out-of-state facilities by 1990. The FRTC project advances these goals in part. To the extent SED patients placed outside the state for residential treatment services are HRS patients whom FRTC as yet has not contracted to treat, the FRTC project does not advance this goal. However, increased insurance reimbursement will advance accessibility for those SED children and adolescents in need of this type of care whose families have insurance coverage. The State Plan also emphasizes a goal for a continuum of care. The FRTC plan advances this goal. Financial Feasibility William S. Love, Senior Director of Hospital Operations for Charter, was accepted as an expert in health care finance. Mr. Love prepared the pro forma financial statement contained in the original CON application and the update of the pro forma in response to HRS' completeness questions. Mr. Love also had input into the updated financial information which increased salary and benefit expense. (See FOF No. 11). The revised pro forma utilized an assumption of gross patient revenues of $300 per day and a 365 day ALOS, both of which are reasonable and both of which support the rest of FRTC's assumptions (See FOF No. 9). Routine revenues are based on the types of routine services patients normally receive on a daily basis. Ancillary revenues are support revenues such as pharmacy charges, X-rays, lab charges, and other charges not generally utilized on a routine basis. The only charges to patients at the proposed FRTC facility are the routine and ancillary charges. The assumptions with regard to contractual adjustments are that there will be no Medicare utilization since the facility is projected for children and adolescents and no Medicaid since freestanding facilities in Florida are not eligible for Medicaid. Two percent of gross patient revenues are estimated to be contractual adjustments which relate to HMOs and PPOs. FRTC addresses indigent care by 1.5 percent of gross revenues which will be dedicated to Charter Care which is free care. The assumptions with regard to bad debt are that 8 percent of gross revenue will be the allowance for bad debt. An assumption of 20 percent of salaries was used for employee benefits which include the FICA tax, health insurance, dental insurance, retirement plans, and other benefits. Supplies and expenses were calculated as a function of patient day with a $90 per day estimate. Included in supplies and expenses are supplies utilized in the delivery of health care services as well as medical professional fees such as the half-time medical director and purchased services such as laundry, linen, speech and hearing services, utilities, telephone, malpractice insurance, repairs and maintenance. The depreciation assumptions are that the building would be depreciated over 40 years, fixed equipment over 20 years and major movable equipment over 10 years. Pre-opening expenses for the first 45 days of operation have been capitalized over 60 months with low amortization costs over 15 years. There is no income tax assumed in the first year but the assumption in subsequent years is that the tax rate will be 38 percent. The failure to assume a hospital tax is inconsequential. The assumptions for the second fiscal year are basically the same. Although staffing remained the same, the FTEs per occupied bed increased, and a 7 percent inflation factor was added. The project will be financially feasible even though the facility is pessimistically projecting a loss of $102,000 for the first year because a facility can suffer a loss in its first year of operation and remain financially feasible. The facility projects a $286,000 profit in its second year of operation. With regard to utilization by class of pay, FRTC has assumed that the insurance category represents 65.5 percent of total revenues projected and includes such things as commercial insurance, Blue Cross and any third party carrier other than Medicare and Medicaid. Assumptions with regard to the private pay are that 25 percent of the total revenues will be generated by private pay patients and would include the self pay portions of an insurance payor's bill, such as deductible and co-insurance. Bad debt was assumed to be 8 percent, and Charter Care or free care, 1.5 percent. FRTC's projected utilization by class of pay is reasonable and is supported by the protestants' current experience with commercial insurance utilization and reimbursement and the predicted recoveries if RTCPB were IRTP-licensed. In the second year of operation, the assumptions with regard to utilization by class of pay demonstrated an increase in the insurance category from 65.5 to 66.5 percent with everything else remaining the same except for a decrease in bad debt to 7 percent. The assumption with regard to a decrease in bad debt is based upon the establishment of referral patterns from acute psychiatric facilities, outpatient programs, mental health therapists, and miscellaneous programs. The assumption is that 65 percent of the patients would be covered by insurance, not that 65 percent of each bill would be paid by insurance. Charter's experience has been that a good portion of the deductible and co-insurance payments are collectible. FRTC did not assume payment from any governmental contracts or HRS reimbursement. FRTC's projected self pay percentages assumption reasonably contemplates the percentage of households in the district which can afford its projections for self pay. For purposes of evaluating the financial feasibility of this proposal, a management fee was not included because in looking at the financial feasibility of a facility the expenses of a corporate home office are incurred whether or not the facility is built. It was not appropriate to allocate a management fee to the hospital because it showed a loss in its first year of operation and a profit in its second. When the facility becomes profitable, FRTC anticipates passing the profit through to the corporation to help reduce the corporate overhead. If a management fee had been allocated to this facility, allocations would have had to have been made to the other Charter facilities to show where their management expense had decreased and their profitability increased. It would have been inappropriate to take these fixed expenses and allocate a portion of them to the proposed FRTC facility. In addition to the fact that the failure to include a management fee in the pro forma should not affect the feasibility of the project, Charter has good cause not to apply a $44 per patient day management fee in its IRTP. FRTC's categories of payor class are generally reasonable based in part on the results of a survey performed in Florida. FRTC's assumptions and calculations are reasonable, based upon the testimony of William S. Love and Dr. Ronald Luke, notwithstanding the testimony of Dan Sullivan, Donald Wilson, and Christopher Knepper, also qualified as experts. Specifically, it is found that Dr. Luke's assessment that the designation of a facility as a licensed specialty hospital has a beneficial effect on its ability to obtain insurance reimbursement for services, that reimbursement impacts to increase ALOS, and that the breakdown of sources of payment that FRTC has used is reasonable, is a credible assessment, supported elsewhere in the record. It is also found that Mr. Knepper's assessment for bad debt is inadequately supported and inconsistent with other evidence, and therefore not credible. Mr. Sullivan's testimony is not persuasive. Staffing and Recruitment Dr. Brett, a Charter regional director for hospital operations, was accepted as an expert in staffing psychiatric facilities including residential treatment centers. His distinctions between the acute care and residential types of facilities are corroborated and explained by other witnesses and evidence. Mr. Joyner was accepted as Charter's expert recruiter. Although the depth of Mr. Joyner's hands-on involvement in active recruitment is not extensive, the Charter network of manpower referrals and "head hunting" will obviously support this project. Upon the combined testimony of Dr. Brett, Mr. Joyner, and Paul Bodner, Charter's senior director of physician relations, there is sufficient evidence that FRTC can recruit a suitable staffing pattern to ensure quality of care (see FOF Nos. 9 and 10) in its proposed program, even if it has to hire from out of state and pay somewhat higher salaries due to some qualified manpower shortages in certain categories in Palm Beach County. In making this finding, the undersigned has considered the testimony of Donald Wilson concerning certain institution-specific recruiting problems of his principal, RTCPB, and the "step down" status of residential treatment as testified by Mary Certo, of Humana. Impact on Costs and Competition The FRTC project can reasonably be expected to attract patients with insurance coverage who would otherwise go to existing facilities for care, however, in light of the relatively consistent occupancy rates at Humana and RTCPB despite both their geographical proximity and the unique confusion of referrals arising over the relocation of Dr. Kelly, this impact is not altogether clear. Dr. Kelly's reputation will not be impacted by granting of a CON to FRTC. It is also not possible upon the basis of the record created in this hearing to factor out reimbursement differences inherent in Humana's current CON classification and RTCPB's circumstance as an unlicensed intensive residential treatment center. In any case, the negative impact upon Humana must be measured against the health planning goals expressed by several witnesses that it is desirable to substitute more suitable, less restrictive facilities for institutionalization of the severely emotionally disturbed child and adolescent whenever possible and that it is also desirable to encourage residential treatment upon a continuum of care basis after acute psychiatric care. The FRTC project will obviously increase the accessibility to this type of treatment for young people who have the appropriate insurance coverage. These goals are in conformity with the applicable health plans. The FRTC project can reasonably be expected to initially increase some costs of health services throughout the district because it will inflate some salary costs due to competition, but the negative impact will probably be short term.
Recommendation Upon a balanced consideration of all relevant criteria it is RECOMMENDED that HRS enter a Final Order approving FRTC's CON application for an IRTP, as updated, for licensure as a specialty hospital. DONE and ORDERED this 28th day of June, 1988, in Tallahassee, Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of June, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NOS. 87-2037 & 87-2050 The following constitute specific rulings pursuant to Section 120.59(2), F.S., with regard to the parties' respective Proposed Findings of Fact. Proposed Findings of Fact (PFOF) of FRTC: Covered in "issue" and FOF 1. Covered in FOF 1 and 2. 3-7. Except as subordinate or unnecessary, accepted in "procedural and evidentiary matters" and FOF 11. 8. Accepted in FOF 12. 9-12. Except as subordinate, unnecessary, or cumulative, accepted in FOF 7-9. 13. Accepted in FOF 10. 14-17. Accepted in part and rejected in part in FOF 7-11, 30. Although portions of the underlying data referred to in proposal 16 and by Mr. Joyner in his testimony was excluded from evidence, he was qualified as a recruitment expert and for the reasons set forth in FOF 30, his opinion is accepted. 18-19. Accepted in FOF 21. Accepted in FOF 22, 26, 29. Accepted in FOF 23. Accepted in FOF 24. Accepted in FOF 25 and 29. Accepted in FOF 26 and 29. Except as subordinate or unnecessary, covered in FOF 27. Except as mere argument or statement of position, accepted in FOF 26-27, and 29. 27-29. Accepted in part and rejected in part as unnecessary and cumulative to the facts as found; in part rejected as mere argument or recital of testimony, not distinguishing opinion from fact. To the degree adopted or accepted upon the record as a whole, see FOF 26-29. 30-31. Accepted in FOF 28. 32-40. Accepted in part and rejected in part as unnecessary and cumulative to the facts as found; in part rejected as mere argument or recital of testimony, not distinguishing opinion from fact. To the degree adopted or accepted upon the record as a whole, see FOF 9, 11, 21, 26-29. 41-44. Accepted in part and rejected in part as unnecessary and cumulative to the facts as found in FOF 29-32. 45-47. Rejected, as recital or summation of testimony and as part of preliminary agency review not relevant to this de novo proceeding. 48. Covered in FOF 7, 18-20, 22, and 26. 49-52. dejected as set out in "organic law and legislative background," "procedural and evidentiary matters," FOF 13-15. See also COL. 53. Accepted in FOF 16. 54-58. Rejected in part and accepted in part as set out in FOF 14-15. Rejected where not supported in full by the record as a whole, where subordinate, unnecessary or cumulative to the facts as found and where mere recital of testimony. 59. Accepted in principle and modified to conform to the record in FOF 18-20, 31. 60-61. Accepted in part and rejected in part as stated in "procedural and evidentiary matters" and in FOF 14-16 and the COL. Accepted in FOF 15 and COL. Accepted in FOF 18-20, 31. 64-68. Rejected as unnecessary to the facts as found in FOF 1, 7, 13-15 and 29, also in part as not supported by the record as a whole, and as primarily legal argument and recitation of testimony. Accepted in FOF 3-4 and 30. Accepted in part and rejected in part in FOF 3-4, 7, 26, and 29. 71-74. Except as subordinate or unnecessary, accepted in FOF 5-9 and 30-32. HRS' Proposed Findings of Fact (PFOF): 1-3. Accepted in "organic law and legislative background." 4. (Two paragraphs) Accepted FOF 3-4. Accepted in "issue" and FOF 3-4. Accepted, FOF 29-32. Rejected as unnecessary. Accepted, FOF 1. 10-18 & 20. Except as subordinate or unnecessary, accepted in FOF 5, 6, 15, 26, 31. 19. Rejected as irrelevant. 21-28. Accepted in part as modified to conform to the record as a whole in FOF 6-9, 30-31. The irrelevant, unnecessary or subordinate material has also been rejected. 29-31. Accepted in FOF 4, 9, 21, 26, 29-31. 32-35. Accepted in FOF 7-9. 36-41. Accepted in FOF 7-9 as modified to conform to the record as a whole, to eliminate subordinate and irrelevant matters and to comport with the rulings on the insubstantiality of updates to the CON application, in "procedural and evidentiary matters" and FOF 11. 42-45. Accepted as modified to conform to the record as a whole, to eliminate subordinate and irrelevant matters and to comport with the rulings on the insubstantiality of updates to the CON application in "procedural and evidentiary matters" and FOF 9-11, 21, 23, 30 and 32. Accepted in FOF 22, 26, 29. Accepted in FOF 7, 20, 22, 26. 49-52. Accepted in FOF 3, 4, 21-29. Assuming, based on the transcript reference, that this proposal refers to FRTC's pro forma, this proposal is accepted but unnecessary for the reasons set forth in rulings on HRS' PFOF 36-45. See FOF 11 and 21-29. Accepted in FOF 13-15. 55-58. Rejected as unnecessary. 59. Accepted but not dispositive of any material issue at bar. See FOF 13-15. 60-62. Accepted in part and rejected in part in FOF 13-14, as mere recital of testimony and statements of position. 63. Accepted in FOF 29. 64-65. Accepted in FOF 5-9. Accepted in FOF 7-9. Accepted that HRS made this assumption but it fails to explicate the non-rule policy. See FOF 13-14. Accepted in FOF 16. Rejected as a statement of position or COL. Peripherally, see COL. Accepted in FOF 13-14 but not dispositive of any material issue at bar. Rejected in FOF 13-14. 72-74. Rejected as preliminary agency action, irrelevant to this de novo proceeding. 75-76. Accepted in FOF 17-20. This is a subordinate definition and not a FOF. See FOF 30-31 and COL. Rejected in part and accepted in part in FOF 17-20, 31. Accepted in FOF 10. Accepted in FOF 13-15. Accepted as stated in the "procedural and evidentiary matters," FOF 13-15 and in the COL. 82-85. Covered in FOF 3-6, 13-15. 86. Rejected as preliminary agency action, irrelevant to this de novo proceeding. 87-88. Rejected as subordinate or unnecessary. 89. Accepted in FOF 29. 90-96. Accepted as modified to conform to the record evidence as a whole and FOF 15-16 and to reject subordinate and unnecessary material. Accepted without any connotations of the word "therefore" in FOF 4, 7-9, 21 and 29. Rejected as unnecessary and cumulative. Accepted in "organic and legislative background" and FOF 13-15. Rejected as not established upon the record as a whole; unnecessary. Rejected as a statement of position only. Joint Proposed Findings of Fact of RTCPB and Humana 1-2 Accepted in FOF 1. 3-4. Accepted in FOF 2. 5-6. Accepted in "issue" and FOF 3-4. 7. Accepted in "issue" and FOF 5-6. 8-13. Accepted in part and rejected in part as set out under "procedural and evidentiary matters," FOF 3-6, 13-15, and the COL. 14-18. Except as subordinate or unnecessary, accepted in FOF 1, 7-9, 11, 21-29. 19-27. Rejected as irrelevant preliminary action to this de novo proceeding. 28-36. Rejected in part and accepted in part upon the compelling competent, substantial evidence in the record as a whole as set forth in FOF 13-14. Also as to 33 see FOF 15. 37-52. Accepted in part and rejected in part in FOF 13-16 upon the greater weight of the credible evidence of record as a whole. Irrelevant, unnecessary and subordinate material has been rejected, as has mere argument of counsel. Accepted in FOF 17. Rejected in FOF 20, 31. Accepted as modified in FOF 20, 31. Excepting the mere rhetoric, accepted in FOF 18, 31. Accepted as modified in FOF 7, 18-20, 26, 31. 58-59. Accepted in part and rejected in part in FOF 17-20, 26, Rejected as subordinate. Rejected as recital of testimony and argument 62-63. Rejected as unnecessary. 64-67. Accepted in FOF 3-4, 6-9. The first sentence is rejected as cumulative to the facts as found in FOF 3-4, 6-9. The second sentence is rejected as not supported by the greater weight of the evidence as a whole. Rejected in FOF 4, 21. Accepted in FOF 4 and 21, 29. Rejected as unnecessary Accepted in FOF 26. Rejected in FOF 15-20, 31. Rejected as unnecessary in a noncomparitive hearing. 75-87. Except as irrelevant, unnecessary, or subordinate, accepted in FOF 5-9, 30, 31. Rejected in part as unnecessary and in part as not comporting with the greater weight of the evidence in FOF 7-10 and 30. Accepted in FOF 1, 5-9. 90-92. Accepted in FOF 5-9. Rejected in FOF 5-6. Rejected as subordinate. 95-98. Accepted in FOF 5-9. 99-102. Rejected as unnecessary. 103. Except as subordinate or unnecessary, accepted in FOF 5-9. 104-118. Except as unnecessary, subordinate, or cumulative to the facts as found, these proposals are covered in FOF 5-9, 30-31. Except as Subordinate, covered in FOF 6 and 31. Accepted in part in FOF 5-9, 21-29, otherwise rejected as misleading. Except as subordinate, accepted in FOF 6. Rejected as unnecessary. Accepted in FOF 21. Accepted in FOF 21-29. Rejected in part and accepted in part in FOF 21-29. Rejected as subordinate and unnecessary in part and not supported by the greater weight of the credible evidence in 21-29. 127-128. These proposals primarily recite testimony by Mr. Grono, an administrator of a psychiatric hospital for very severely disturbed persons (Grant Center). This evidence by itself is not persuasive in light of Dr. Luke's study and other admissions of the parties referenced in FOF 21-29. Upon the greater weight of contrary evidence, it is rejected. 129. Rejected as subordinate except partly accepted in FOF 29. 130-133. Rejected upon the greater weight of the evidence in FOF 9, 11 and 21-29. 134, 139. Rejected as legal argument without citation. 135-138. Rejected in FOF 21-29. 140-144. Rejected as stated as not supported by the greater weight of the credible evidence and as partly mere legal argument. See FOF 9, 21-29. 145. The first sentence is rejected upon the reference to PFOF 140-144 for the same reasons given above and the remainder is rejected as subordinate. 146. Rejected in FOF 21-29. 147. Rejected as mere legal argument without citation. 148-149. Rejected in FOF 21-29, particularly 27 upon the greater weight of the credible evidence. The mere legal argument is also rejected. 150-157. Rejected as set out in FOF 28 upon the greater weight of the credible evidence. Uncited argument and statements of position have likewise bean rejected. 158, 160. Rejected as mere argument without citation. 159. Rejected as subordinate and not dispositive of any material issue at bar in FOF 23. 161. Rejected as mere argument. 162-167. Rejected as not supported by the greater weight of the credible evidence in FOF 30-32. Also 167 is rejected as mere argument without citation. 168. Accepted in part and rejected in part in FOF 30-32. 169. Accepted but subordinate. 170. Rejected as unnecessary and cumulative to the facts as found in FOF 31. 171-180. Covered in FOF 30-32. 181-185. Rejected as contrary to the evidence in part and in part unnecessary and cumulative to the ruling in "procedural and evidentiary matters" and FOF 7, 10-11, 21, 23, 30-32. 186-188. Rejected in FOF 7, 10 and 30 upon the greater weight of the credible evidence. 189. Rejected as unnecessary 190. Rejected in FOF 30. 191-392. Accepted but not dispositive of any material issue at bar. See FOF 30-32. 193. Rejected in FOF 30-32. 194-195. Except as subordinate or unnecessary, rejected in the several references to future establishment of referral networks. See FOF 21, 27. 196-197 & 199. Rejected as unnecessary 198. Rejected as irrelevant in part and immaterial in part upon the rulings in "procedural and evidentiary matters" and FOF 11. 200. Rejected as unnecessary 201-202. Accepted in FOF 7, 20, 26-27 and 31, but cumulative. 203. Covered in the COL. Rejected in FOF 21-22. 204. Rejected as mere argument without citation. COPIES FURNISHED: Michael J. Glazer, Esquire AUSLEY, McMULLEN, McGEHEE, CAROTHERS & PROCTOR 227 South Calhoun Street Post Office Box 391 Tallahassee, Florida 32302 John T. Brennan, Jr., Esquire BONNER & O'CONNEL 900 17th Street, N.W. Washington, D.C. 20006 James C. Hauser, Esquire Joy Heath Thomas, Esquire MESSER, VICKERS, CAPARELLO, FRENCH & MADSEN 215 South Monroe Street Post Office Box 1876 Tallahassee, Florida 32302 Fred W Baggett, Esquire Stephen A. Ecenia, Esquire ROBERTS, BAGGETT, LaFACE & RICHARD 101 East College Avenue Tallahassee, Florida 32301 Lesley Mendelson, Esquire Assistant General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner Brookwood Medical Center of Lake City, Inc., d/b/a Lake City Medical Center (hereinafter referred to as LCMC) is a 75-bed acute care hospital, which presently has 65 medical/surgical beds and 10 alcohol treatment beds. Plans are under way to convert 10 of the medical/surgical beds to a psychiatric unit with 10 beds. LCMC primarily serves Columbia County, a primarily rural community with a population of 34,625, and derives 74 percent of its patients therefrom. The remaining 261 of its admissions come from the surrounding counties of Hamilton, Lafayette and Suwannee. Approximately 60 percent of its patients are sixty years of age or older. The source of reimbursement for the year 1980 was 40 percent Medicare, 8 percent Medicaid, 8 percent indigent or bad debt, and the remaining portion from other third-party payors. The current occupancy rate at LCMC is approximately 502 or 37.5 patients per day. Seasonal trends cause this figure to vary between 32 and 37.5. The daily census is expected to increase over the next year due to the planned addition of four new programs. These include the ten-bed psychiatric unit for which a Certificate of Need application is pending, an industrial medical and occupational health program which would provide on-site care to employees and their family members, the recruitment of an internist/cardiologist and the recruitment of an ophthalmologist. It is projected that the proposed new psychiatric unit will add eight patients to LCMC's daily census, the industrial health program will add 2.5 patients per day as well as outpatients, and that the internist/cardiologist will generate five patients per day. Psychiatric beds are less likely to generate intensive care patients than medical/surgical beds. It is expected that LCMC's program of expansion will change the mix of the primary and secondary service areas and will increase the average daily census to 42.5 by the end of 1981. Petitioner presently has a nursing staff of 48 and a medical staff of Of its medical staff, 13 are listed as active, 4 as courtesy, 4 as consulting and one with temporary privileges. LCMC has one operating room, no emergency room, and no intensive care/cardiac care unit (also referred to as IC/CCU). On an average basis, it is estimated that from ten to twelve surgical procedures per week are performed at LCMC. In 1980, 468 surgical procedures were performed. For the first quarter of 1981, the busiest time of the year, 156 surgical procedures were performed. Petitioner does have a step-down unit or a progressive care unit (also referred to as PCU) with four beds. The current utilization of the PCU is 2.7 patients per day, with a 50 percent medical component and a 50 percent surgical component. If petitioner's application for a Certificate of Need were granted, LCMC's PCU would be converted to an IC/CCU with invasive monitoring capabilities and patients who currently receive treatment in the PCU would be treated in the new IC/CCU. The current patient charge for the PCU is $111.00 per day. LCMC proposes an IC/CCU charge of $250.00 per day. Petitioner estimates that 8 percent of its patients would need and use an IC/CCU, and that, for the first year of operation, the IC/CCU would have a daily census of 3.5 patients. For the second year of operation, a daily patient census of 4.5 is projected. The projected daily utilization of over 50 percent is not consistent with actual utilization achieved in the IC/CCUs of other hospitals in the area. The prime concept of an IC/CCU is to provide more intensive nursing care and monitoring capabilities for unstable medical and surgical patients. The majority of admissions to an IC/CCU come from the emergency room and the second largest source is from the operating room after surgery. While some physicians feel that no physician or acute care facility should be without an IC/CCU, that all post-operative patients should be monitored in an ICU and that it is not good practice to transport an unstable patient under any circumstances, others disagree. These physicians, while agreeing that all hospitals need some form of life support capability, feel that for general routine surgery, only a very small percentage of patients are in need of an intensive care unit. It is possible to reduce the need for an intensive care unit by screening patients prior to surgery. A recovery room and/or a progressive care unit can provide the routine noninvasive monitoring and more intensive nursing care and observation needed by many medical and surgical patients. The use of a recovery room for critical care patients does pose serious problems due to the exposure to additional commotion and the potential mixing of well surgical patients with septic unstable patients. It is better medical practice to have separate personnel for infectious and noninfectious patients. The transfer of an unstable patient to another facility can pose serious risk to the patient. The intervenor Lake Shore Hospital (also referred to as LSH) is located approximately 1.5 miles from the petitioner. Lake Shore Hospital is a full- service, acute care, public hospital with 128 beds, an emergency room and a 9- bed IC/CCU. LSH has had an IC/CCU since 1970 or 1971. More than 50 percent of its intensive care patients come from its emergency room. Approximately 1600 surgical operations per year are performed at LSH. The IC/CCU at LSH provides basic noninvasive monitoring equipment connected to the patient's bedside and the nurses' stations. It does not presently have Swans-Ganz monitoring equipment, an invasive device which measures a patient's hemodynamics. The wiring and other equipment for two such monitoring capabilities are in place and, with the addition of a module and transducer for each unit, two units can be installed for a cost of approximately $4,400.00. At the present time, no one in Lake City has the extensive training required to utilize the Swans-Ganz monitoring equipment. LSH is in the recruitment process and plans to purchase and install this equipment when a cardiologist or other trained specialist is recruited. The IC/CCU at LSH experiences an occupancy rate of 3.5 patients per day, or 35 percent of its capacity. It has only achieved full capacity on two occasions in the ten years of its existence. Lake Shore Hospital presently charges $275.00 per day for the use of its IC/CCU. If it were to lose one patient per day, LSH would lose approximately $100,000.00 per year in revenue. Such a loss could result in either increased taxes or increased patient charges. In spite of the fact that several major admittors to LCMC and LSH have their offices at LCMC, It was their testimony that were a Certificate of Need granted to LCMC for an IC/CCU, they would continue to admit and refer patients to both facilities. Lake Shore Hospital has a medical staff of 22 or 23 specialists and nonspecialists. Of this number, all but one are also on the staff of Lake City Medical Center. The PCU at LCMC and the IC/CCU at LSH are presently comparable. While the nursing staff at Lake Shore's IC/CCU is better trained, at least one physician who practices at both hospitals felt that the same level of care could presently be obtained at LCMC's PCU as at LSH's IC/CCU. This is due to the fact that LSH does not now have the invasive monitoring capabilities felt to be essential to an IC/CCU. The traditional difference between a PCU and an IC/CCU is the degree of training of the nursing staff and the sophistication of the equipment. Underutilization of an IC/CCU can have an adverse effect upon the quality of care provided. One of the most important aspects of an intensive care unit is superior trained personnel. A reduction in patient use obviously reduces the personnel's exposure to complications and skills become dull. Thus, a reduction in patients reduces the quality of care. There is presently a shortage of nurses in the Lake City area. Lake Shore Hospital presently has 8 nursing vacancies and has been actively recruiting to fill those vacancies. In order to operate its proposed IC/CCU, LCMC would have to employ two full-time equivalent nurses with training in that area. The petitioner projects the cost of its requested IC/CCU to be $240,000.00. In 1979, LCMC ran a deficit of $1 million, the sixth largest loss in the State. In 1980, the deficit was $390,000.00. LCMC is presently experiencing a positive cash flow for 1981. It appears that LCMC anticipates the proposed IC/CCU to be a profit-making venture and projects that, if its presumptions are true with respect to patient use, the project will be financially feasible. At the time of the hearing, negotiations were under way for the sale of petitioner to another entity. The reviewing Health Systems Agency, the North Central Florida Health Planning Council, Inc. (NCFHPC), unanimously denied the petitioner's request for an IC/CCU at every level of the review process. The 1981-1985 Health Systems Plan for the NCFHPC contains certain criteria and standards for intensive and coronary care units which should he met within five years of operation. Two of the criteria are that an IC/CCU should have an average annual occupancy rate of 80 percent and that an IC/CCU should be available within one hour's (one-way) travel time of 95 percent of the region's residents. As noted above, LSH is approximately 1.5 miles away from LCMC. Lake City is 45 miles from Gainesville and 65 miles from Jacksonville with interstate highways connecting these cities. With an optimal utilization rate of 80 percent, it is projected that 8.5 IC/CCU beds are needed in the planning area in 1980, and, by 1985, there will be a need for 9 beds. There are presently 15 IC/CCU beds in the Level 2 planning area, which includes Lafayette, Suwannee, Hamilton and Columbia Counties. Of the licensed 212 acute care medical/surgical hospitals in Florida, 22 or 10 percent do not have intensive or coronary care units. The approximate bed size of most of these facilities is 50.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that petitioner's application for a Certificate of Need to construct and operate an intensive care/coronary care unit at Lake City Medical Center be DENIED. Respectfully submitted and entered this 7th day of August, 1981, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of August, 1981. COPIES FURNISHED: John H. French, Jr. Messer, Rhodes and Vickers Post Office Box 1876 Tallahassee, Florida 32301 Donna H. Stinson General Counsel Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301 Jon Moyle and Thomas Sheehan, III Moyle, Jones and Flannagan, P.A. 707 North Flagler Drive Post Office Box 3888 West Palm Beach, Florida 33402 Honorable Alvin J. Taylor Secretary, Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301
