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
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 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 the application of Petitioner Naples Community Hospital, Inc. for a Certificate of Need to add a total of 35 beds to Naples Community Hospital and North Collier Community Hospital should be approved based on peak seasonal demand for acute care beds in the relevant subdistrict.
Findings Of Fact Naples Community Hospital, Inc., ("NCH") holds the license for and operates Naples Community Hospital ("Naples"), a 331 bed not-for-profit acute care hospital, and North Collier Community Hospital ("North Collier"), a 50 bed acute care hospital. NCH also operates a 22 bed comprehensive rehabilitation facility and a 23 bed psychiatric facility. NCH is owned by Community Health Care, Inc., "(CHC"). Both Naples and North Collier are located within Agency for Health Care Administration ("ACHA") district 8 and are the only hospitals within subdistrict 2 of the district. Naples is located in central Collier County. North Collier is (as the name implies) located in northern Collier County approximately 2-3 miles from the county line. NCH's primary service area is Collier County from which approximately 85-90 percent of its patients come, with a secondary service area extending north into Lee County. Neither Naples nor North Collier are teaching hospitals as defined by Section 407.002(27), Florida Statutes (1991). NCH is not proposing a joint venture in this CON application. NCH has a record of providing health care services to Medicaid patients and the medically indigent. NCH proposes to provide health care services to Medicaid patients and the medically indigent. Neither Naples nor North Collier are currently designated by the Office of Medicaid as disproportionate share providers. NCH has the funds for capital and initial operating expenditures for the project. NCH has sufficient financial resources to construct and equip the proposed project. The costs and methods of the proposed construction are reasonable. The Agency for Health Care Administration ("AHCA") is the state agency charged with responsibility for administering the Certificate of Need program. Southwest Florida Regional Medical Center ("Southwest") is a 400 bed for-profit acute care hospital located in Fort Myers, Lee County. Lee County is adjacent to and north of Collier County. Southwest is owned by Columbia Hospital Corporation ("Columbia"), which also owns Gulf Coast Hospital in Fort Myers, and two additional hospitals in AHCA District 8. Southwest's primary service area is Lee County. Although Southwest asserts that it would be negatively impacted by the addition of acute care beds at NCH, the greater weight of the credible evidence fails to support the assertion. The primary market services areas of NCH and Southwest are essentially distinct. However, the facilities are located in such proximity as to indicate that secondary service areas overlap and that, at least during peak winter season periods, approval of the NCH application could potentially impact Southwest's operations. Southwest has standing to participate in this proceeding. Southwest offered evidence to establish that it would be substantially affected by approval of the NCH application. The NCH length-of-stay identified in the Southwest documents is inaccurate and under-reports actual length-of-stay statistics. The documentation also includes demographic information from a zip code (33912) which contributes an insignificant portion of NCH patients, and relies on only two years of data in support of the assertion that utilization in the NCH service area is declining. Southwest's chief operating officer testified that he considers Gulf Coast Hospital, another Columbia-owned facility, to offer more competition to Southwest that does NCH. Further, a physician must have admitting privileges at a hospital before she can admit patients to the facility. Of the physicians holding admitting privileges at Southwest, only two, both cardiologists, also have admitting privileges at NCH. Contrary to Southwest, NCH does not have an open heart surgery program. Accordingly, at least as to physician-admitted patients, approval of the NCH application would likely have little impact. On August 26, 1991, NCH submitted to AHCA a letter of intent indicating that NCH would file a Certificate of Need ("CON") application in the September 26, 1991 batching cycle for the addition of 35 acute care beds to the Naples and North Collier facilities. The letter of intent did not specify how the additional beds would be divided between the two facilities. The determination of the number of beds for which NCH would apply was solely based on the fact that the applicant had 35 observation beds which could be readily converted to acute care beds. The observation beds NCH proposes to convert are equipped identically to the acute care beds at NCH and are currently staffed. The costs involved in such conversion are minimal and relatively insignificant. Included with the letter of intent was a certified corporate resolution which states that on July 24, 1991, the NCH Board of Trustees authorized the filing of an application for the additional beds, authorized NCH to incur related expenses, stated that NCH would accomplish the proposed project within time and budget allowances set forth in the application, and that NCH would license and operate the facility. By certification executed August 7, 1991, the NCH secretary certified that the resolution was enacted at the July 24, 1991 board meeting and that the resolution did not contravene the NCH articles of incorporation or bylaws. Article X, Sections 10.1 and 10.1.3 of the NCH bylaws provides that no CON application shall be legally effective without the written approval of CHC. On September 26, 1991, NCH filed an application for CON No. 6797 proposing to add 31 acute care beds to Naples and 4 acute care beds to North Collier. The CON application included a copy of the NCH board resolution and certification which had been previously submitted with the letter of intent as well as the appropriate filing fee. NCH published appropriate public notice of the application's filing. As of the date of the CON application's filing, CHC had not issued written approval of the CON application prior to the action of the NCH Board of Directors and the filing of the letter of intent or the application. On October 2, 1992, four days prior to the administrative hearing in this case, the board of CHC ratified the actions of NCH as to the application for CON at issue in this case. The CHC board has previously ratified actions of the NCH in such fashion. There is uncontroverted testimony that the CHC board was aware of the NCH application and that no reservation was expressed by any CHC board member regarding the CON application. Although NCH's filing of the CON application without appropriate authorization from its parent company appears to be in violation of the NCH bylaws, such does not violate the rules of the AHCA. There is no evidence that the AHCA requested written authorization from the CHC board. After review of the application, the AHCA identified certain deficiencies in the application and notified NCH, which apparently rectified the deficiencies. The AHCA deemed the application complete on November 8, 1991. As required by statute, NCH included a list of capital projects as part of the CON application. The list of capital projects attached to the application was incomplete. The capital projects list failed to identify approximate expenditures of $370,000 to construct a patio enclosure, $750,000 to install an interim sprinkler system, $110,000 to construct emergency room triage space, and $125,000 to complete electrical system renovations. At hearing, witnesses for NCH attempted to clarify the omissions from the capital projects list. The witnesses claimed that such omitted projects were actually included within projects which were identified on the list. When identifying the listed projects within which the omitted projects were supposedly included, the witnesses testified inconsistently. For example, one witness testified that the patio project was included in the emergency room expansion project listed in the application. Another witness claimed that the patio enclosure was included in an equipment purchase category. Based on the testimony, it is more likely that the patio enclosure was neither a part of an emergency room expansion nor equipment purchase, but was a separate construction project which was omitted from the CON application. Similarly inconsistent explanations were offered for the other projects which were omitted from the capital projects list. The testimony was not credible. The capital projects omitted from the list do not affect the ability of NCH to implement the CON sought in this proceeding. The parties stipulated to the fact the NCH has sufficient financial resources to construct and equip the proposed project. As part of the CON application, NCH was required to submit a pro forma income statement for the time period during which the bed additions would take place. The application failed to include a pro forma statement for the appropriate time period. Based on the stipulation of the parties that the costs and methods of the proposed construction are reasonable, and that NCH has adequate resources to fund the project, the failure to include the relevant pro forma is immaterial. Pursuant to applicable methodology, the AHCA calculates numeric acute care bed need projections for each subdistrict's specific planning period. Accordingly, the AHCA calculated the need for additional acute care beds in district 8, subdistrict 2 for the July, 1996 planning horizon. The results of the calculation are published by the agency. The unchallenged, published fixed need pool for the planning horizon at issue in this proceeding indicated that there was no numeric need for additional acute care beds in district 8, subdistrict 2, Collier County, Florida, pursuant to the numeric need methodology under Rule 59C-1.038 Florida Administrative Code. The CON application filed by NCH is based on the peak seasonal demand experienced by hospitals in the area during the winter months, due to part-time residents. NCH asserts that the utilization of acute care beds during the winter months (January through April) results in occupancy levels in excess of 75 percent and justifies the addition of acute care beds, notwithstanding the numerical need determination. Approval of the CON application is not justified by the facts in this case. The AHCA's acute care bed need methodology accounts for high seasonal demand in certain subdistricts in a manner which provides that facilities have bed space adequate to accommodate peak demand. The calculation which requires that the average annual occupancy level exceed 75 percent reflects AHCA consideration of occupancy levels which rise and fall with seasonal population shifts. The applicant has not challenged the methodology employed by the AHCA in projecting need. Peak seasonal acute care bed demand may justify approval of a CON application seeking additional beds if the lack of available beds poses a credible threat of potentially negative impact on patient outcomes. The peak seasonal demand experienced by NCH has not adversely affected patient care and there is insufficient evidence to establish that, at this time, such peak demand poses a credible threat of potential negative impact on patient outcomes in the foreseeable future. There is no dispute regarding the existing quality of care at Naples, North Collier, Southwest or any other acute care hospital in district 8. The parties stipulated that NCH has the ability to provide quality of care and a record of providing quality of care. In this case, the applicant is seeking to convert existing beds from a classification of "observation" to "acute care". The observation beds NCH proposes to convert are equipped identically to the acute care beds at NCH. Approval of the CON application would result in no net increase in the number of licensed beds. NCH offered anecdotal evidence suggesting that delays in transferring patients from the Naples emergency room to acute care beds (a "logjam") was caused by peak seasonal occupancy rates. There was no evidence offered as to the situation at the North Collier emergency room. The anecdotal evidence is insufficient to establish that "logjams" (if they occur at all) are related to an inadequate number of beds identified as "acute care" at NCH facilities. There are other factors which can result in delays in moving patients from emergency rooms to acute care beds, including facility discharge patterns, delays in obtaining medical test results and staffing practices. NCH asserted at hearing that physicians who refer patients to NCH facilities will not refer such patients to other facilities. The evidence fails to establish that such physician practice is reasonable or provides justification for approval of CON applications under "not normal" circumstances and further fails to establish that conditions at NCH are such as to result in physicians attempting to locate other facilities in which to admit patients. The rule governing approval of acute care beds provides that, prior to such approval, the annual occupancy rate for acute care beds in the subdistrict or for the specific provider, must exceed 75 percent. This requirement has not been met. Applicable statutes require that, in considering applications for CON's, the AHCA consider accessibility of existing providers. The AHCA- established standard provides that acute care bed accessibility requirements are met when at least 90 percent of the residents in an urban subdistrict are within a 30 minute automobile trip to such facilities. At least 90 percent of Naples residents are presently within a 30 minute travel time to NCH acute care beds. The number of acute care beds in the subdistrict substantially exceed the demand for such beds. Additional beds would result in inefficient utilization of existing beds, would further increase the current oversupply of beds, would delay the time at which need for additional beds may be determined and, as such, would prevent competing facilities from applying for and receiving approval for such beds. The financial feasibility projections set forth in the CON application rely on assumptions as to need and utilization projections which are not supported by the greater weight of the evidence and are not credited. Accordingly, the evidence fails to establish that the addition of 35 acute care beds to NCH facilities is financially feasible in the long term or that the income projections set forth in the CON application are reasonable. As to projections related to staffing requirements and costs, the beds are existing and are currently staffed on a daily, shift-by-shift basis, based on patient census and acuity of illness. There is reason to believe that the staffing patterns will remain fairly constant and accordingly the projections, based on historical data, are reasonable. Generally stated, where there is no numeric or "not normal" need for the proposed addition of 35 acute care beds in the relevant subdistrict, it could be predicted that the addition of acute care beds would exacerbate the oversupply of available beds and could cause a slight reduction in the occupancy levels experienced by other providers. In this case, the market service areas are sufficiently distinct as to suggest that such would not necessarily be the result. However, based on the lack of need justifying approval of the CON application under any existing circumstances, it is unnecessary to address in detail the impact on existing providers. The state and district health plans identify a number of preferences which should be considered in determining whether a CON application should be approved. The plans suggest that such preferences are to be considered when competing CON applications are reviewed. In this case there is no competing application and the applicability of the preferences is unclear. However, in any event, application of the preferences to this proposal fail to support approval of the application.
Recommendation RECOMMENDED that a Final Order be entered DENYING the application of Naples Community Hospital, Inc., for Certificate of Need 6797. DONE and RECOMMENDED this 19th day of March, 1993 in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of March, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 92-1510 To comply with the requirements of Section 120.59(2), Florida Statutes, the following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 3-4, 6-8, 16-20, 29-36, 38, 41, 44, 47, 49-61, 80, 88, 95-96, 100, 104, 108, 117-119, 122-125, 127, 134-138. Rejected as unnecessary. 15. Rejected as irrelevant. Peak seasonal demand is accounted for by the numeric need determination methodology. There is no credible evidence which supports a calculation of three years of four month winter occupancy to reach a 12 month average occupancy rate. 21-27, 37, 42-43, 62-64, 66, 97, 99, 101-103, 105-107, 109, 120-121, 126. Rejected as not supported by the greater weight of credible and persuasive evidence. 28. Rejected as not supported by the greater weight of credible and persuasive evidence and contrary to the stipulation filed by the parties. Rejected as not supported by greater weight of credible and persuasive evidence which fails to establish that the transfer of patients from emergency room to acute care beds is delayed due to numerical availability of beds. Rejected as not supported by greater weight of credible and persuasive evidence which fails to establish that the alleged lack of acute care beds is based on insufficient number of total beds as opposed to other factors which affect bed availability. Rejected as immaterial and contrary to the greater weight of the evidence Rejected as immaterial and contrary to the greater weight of the evidence which fails to establish reasonableness of considering only a four month period under "not normal" circumstances where the period and the peak seasonal demand are included within the averages utilized to project bed need. 86. Rejected as cumulative. 114. Rejected as unsupported hearsay. Respondent/Intervenor The Respondent and Intervenor filed a joint proposed recommended order. The proposed order's findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 6, 45, 51, 53, 59-67, 69-70, 94-113. Rejected as unnecessary. 16. Rejected as to use of term "false", conclusion of law. 58. Rejected as not clearly supported by credible evidence. 71-93, 114-124. Rejected as cumulative. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 W. David Watkins, Esquire Oertel, Hoffman, Fernandez, & Cole Post Office Box 6507 Tallahassee, Florida 32314-6507 Edward G. Labrador, Esquire Thomas Cooper, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 John D.C. Newton, II, Esquire Aurell, Radey, Hinkle, Thomas & Beranek Monroe Park Tower, Suite 1000 101 North Monroe Street Post Office Drawer 11307 Tallahassee, Florida 32302
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 CON APPLICATIONS HCR-CON No.7530 HCR is a publicly owned, for-profit corporation which operates approximately 25 nursing homes in Florida. HCR filed an application, CON No. 7530, to construct a 98-bed freestanding nursing home. HCR proposes to locate the nursing home in the northwest part of Orange County, Florida. HCR proposes that the entire 98-bed facility will be dedicated to the care of patients with Alzheimer's Disease and related dementias. The total cost of the HCR project is $7,132,000 for 47,750 square feet, or $472,776 per bed. The HCR proposal is modeled after an HCR 120-bed nursing home facility in Boynton Beach, Florida. The Boynton Beach facility is entirely dedicated to the treatment of patients with Alzheimer's Disease or related dementias. The proposed HCR facility in Orange County would be identical to the Boynton Beach facility less one patient wing. HCR's Boynton Beach facility, as well as HCR's existing Orange County nursing home facility, have superior licensure ratings. HCR's Boynton Beach facility received accreditation with commendation from the Joint Commission on the Accreditation of Health Care Organizations (JCAHCO), a national accreditation body which has established standards to measure the quality of care in dementia care units. Dementia is a complex of symptoms that can be caused by many different underlying diseases. Alzheimer's disease is one cause of dementia. Alzheimer's disease is the most common cause of dementia. Significant research is being conducted into the cause and treatment of Alzheimer's disease. Dementia is defined as a decline in intellectual function; global cognitive impairment, that is memory impairment and at least one of the following: impairment of abstract thinking; impairment of judgment; impairment of other complex capabilities such as language use, ability to perform complex physical tasks, ability to recognize objects or people, or to construct objects; and, personality change. The Reisberg Cognitive Rating Scale (RCS) classifies the stages of Alzheimer's disease from 1 to 7, with a rating of 7 being most severe. The rating scale is based on 10 axes: concentration, recent memory, past memory, orientation, functioning and self-care, speech, motor functioning, mood and behavior, practice of an art or skill, and calculation ability. The Global Deterioration Scale (GDS) for Age-Associated Cognitive decline and Alzheimer's Disease also defines seven stages of deterioration ranging from no cognitive decline to very severe cognitive decline. Persons suffering from Alzheimer's disease generally cannot survive without assistance upon reaching early dementia or level five on both the RCS and GDS. Approximately 50-58 percent of persons currently residing in community nursing homes suffer from some form of dementia. There is a need for community nursing home beds for persons suffering from the latter stages (levels 5-7) of Alzheimer's disease in Orange County. It is particularly difficult to place in nursing homes in Orange County, persons suffering from the latter stages of Alzheimer's disease (levels 5-7) who also have displayed a history of disruptive behavior patterns. Persons suffering from the latter stages of Alzheimer's disease have specific needs for care and treatment in nursing homes. Alzheimer's victims tend to wander and should have areas set aside for secured walking. The movement of Alzheimer's victims should also be carefully monitored. HCR's Boynton Beach facility, which is the prototype for HCR's proposed Orange County facility, has specific design features to accommodate the needs of patients suffering from the latter stages (levels 5-7) of Alzheimer's disease. HCR proposes a pod design of five residential pod units each with a central living area, also called the atrium area. The resident rooms open to the central living area. Each pod has an enclosed courtyard. Access to the courtyards is controlled. The two nursing stations are centrally located in each wing of the facility. Each central living area, or atrium, is visible from one or the other of the nursing stations. HCR provides specific staff training in the care and treatment of Alzheimer's disease and related dementias. A unit or a facility dedicated to the treatment of dementia patients may reduce the need for psychotropic medication of the patients. On a long-term basis, there may be some staff burnout in a facility or unit dedicated solely to the care and treatment of victims of Alzheimer's disease or related dementias. HCR proposes that its CON be conditioned upon locating in northwest Orange County, providing at least 30 percent of its patient days to Medicaid eligible persons, providing respite care, and dedicating all 98 beds to the care and treatment of persons suffering from Alzheimer's disease and related dementias. HCR currently meets its Medicaid commitment in the Boynton Beach facility. LIFE CARE CON Nos. 7534 and 7534P LIFE CARE is a for-profit corporation which owns and operates two nursing homes in Florida. LIFE CARE also operates three other nursing homes in Florida. As of September 1993, LIFE CARE had a net worth of approximately $50 million. LIFE CARE proposes to construct a freestanding 98-bed nursing home (CON No. 7534) in southwest Orange County, at a total cost of $5,988,000. The LIFE CARE 98-bed facility proposal includes a 20-bed unit dedicated to the care and treatment of persons suffering from Alzheimer's disease, a 20-bed subacute unit, an adult day care center, mental health services, and services to persons suffering from AIDS/HIV. LIFE CARE also made a partial request (CON No. 7534P) for a 60-bed facility which would be constructed at the same site and would include the same features. For economic reasons, patients are being released from acute care hospital settings at earlier stages of recovery and there is a need for subacute nursing home services in Orange County. The incidence of AIDS/HIV is increasing and there is a need for nursing home services for persons suffering from AIDS/HIV in Orange County. The 20-bed unit proposed by LIFE CARE for the care and treatment of Alzheimer's patients will be a distinct part of the facility, separate from other residents. The Alzheimer's unit has its own dining area and activity area, a centrally located bathing facility, and a secured courtyard for wandering space. The 20-bed LIFE CARE subacute unit will also be separate. The subacute unit will have two ventilator areas and be contiguous to a therapy area. The LIFE CARE design includes outdoor courtyards, a library, gift shop, and ice cream parlor. Pursuant to Sections 408.037(2)(a) and (b), Florida Statutes, one of the required elements of a CON application is the listing of capital projects, which is presented in Schedule 2 of the CON application. The Schedule 2 filed by LIFE CARE in these proceedings is identical to the Schedule 2 filed by LIFE CARE in the December 1993 batching cycle for LIFE CARE'S proposed Clay County Project, CON No. 7501. It has been held that Schedule 2 of the LIFE CARE Clay County Project CON application No. 7501 met minimum CON application content requirements. Life Care Centers of America, Inc. v. State of Florida, Agency for Health Care Administration, 20 F.L.W. 1435 (Fla. 1st DCA June 12, 1995). During November of 1993, a LIFE CARE nursing home located in Altamonte Springs was downgraded from a superior to a conditional licensure rating due to a deficiency related to outdated medication. The conditional rating given to the facility was in effect for approximately fifty days. The facility was then given a standard rating, and upon the annual survey in the fall of 1994, the facility has been recommended for a superior rating. All other LIFE CARE facilities have superior ratings. LIFE CARE proposes to condition its CON application upon providing Medicaid participation of 65 percent in the 98-bed facility, and 43 percent in the 60-bed facility. ADVENTIST CON No. 7528 ADVENTIST is a not-for-profit corporation that owns and operates nursing homes, hospitals, and other health care related enterprises. ADVENTIST is a wholly owned subsidiary of Adventist Health System/Sunbelt Health Care Corporation, which owns and operates hospitals and health care facilities throughout the United States. ADVENTIST has operated health care facilities in Orange County since the early 1900s when Florida Hospital was founded. ADVENTIST is the largest hospital system in Orange County, with more than 1,400 beds located on five campuses. ADVENTIST proposes to add 38 beds to an existing freestanding 80-bed community nursing home, Sunbelt Living Center-East Orlando (SLC), which is directly adjacent to Florida Hospital's East Orlando campus. The ADVENTIST proposal would include a 20-bed subacute unit and also an 18-bed skilled nursing unit. This addition to SLC would be accomplished by constructing two new wings to the existing facility. The projected cost of the ADVENTIST addition is $1,386,500, or approximately $36,000 per bed. SLC is an 80-bed skilled nursing facility which opened in January of 1993. SLC has a superior licensure rating. SLC provides nursing home service to a variety of residents, including persons with AIDS/HIV, as well as persons with a primary diagnosis of Alzheimer's disease and related dementia. SLC does not have a distinct Alzheimer's unit, but is equipped with security features to accommodate Alzheimer's patients. SLC staff is trained in the care and treatment of all its residents, including those with dementia. SLC reached an occupancy rate of 96 percent-97 percent capacity in its first ten months of operation. The SLC design is based on a residential model. The intent of the design is to create a residential community, and to encourage the interaction among the residents, and also between the residents and staff. The residential wings contain twelve rooms with private and semiprivate accommodations. Each room has its own toilet facilities. The support facilities, food service, therapy areas, administrative offices, visitor and welcoming areas, are located in the center of the facility. The residential wings are clustered on each side of the facility. The facility also features outdoor courtyards and walkways adjacent to the residential wings. ADVENTIST proposes to condition its CON application on providing a Medicaid commitment of 65 percent of total patient days in the non-subacute wing of the 38-bed expansion. The ADVENTIST proposal also features an AIDS program and respite care. ADVENTIST currently meets it Medicaid commitment at SLC. As indicated above, there is a need for subacute nursing home beds in Orange County. There is a need for nursing home beds for persons suffering from AIDS/HIV in Orange County. In the 20-bed subacute unit ADVENTIST proposes that each room will include wall-mounted suction and gases to accommodate ventilator dependent patients, which will enable ADVENTIST to provide more intensive subacute care. RHA/PRINCETON CON No.7538 RHA is the owner and operator of Princeton Hospital, located on the west side of Orlando. Princeton Hospital is situated on 32 acres bordering Lake Lawne. Princeton Hospital has 150 beds, including 24 psychiatric beds, a multipurpose intensive care unit, a 13-bed progressive care unit, a nursery, pediatric services, women's services, an obstetrical unit and an inpatient cardiac catheterization lab. The psychiatric unit at Princeton Hospital treats a wide range of mental disorders, including those afflicting the elderly population. The hospital also operates a senior psychiatric partial hospitalization program which serves geriatric patients, including persons suffering from Alzheimer's disease and related dementias. Princeton Hospital currently provides care and treatment to persons suffering from AIDS/HIV. Princeton Hospital is accredited by the Joint Commission on Accreditation of Health Care Organizations. On August 1, 1994, subsequent to the filing of CON application No. 7538, Princeton Hospital entered into a wide-ranging affiliation agreement with the University of Florida, College of Medicine and Shands Hospital. The agreement provides for extensive reciprocal training and educational programs between Princeton Hospital and the College of Medicine, as well as Shands Hospital. The agreement also provides for priority transfer of patients between Princeton and Shands hospitals. RHA proposes to include its nursing home facility within the scope of the affiliation agreement. The nursing home staff would benefit from the training and educational opportunities, and the nursing home patients would have access to priority reciprocity with the College of Medicine and Shands Hospital as provided for in the agreement. During fiscal years 1993 and 1994 Princeton Hospital had a Medicaid patient ratio of approximately 40 percent. Princeton Hospital also provides indigent care. RHA proposes to construct a freestanding 60-bed Medicaid certified skilled nursing facility on the campus of Princeton Hospital at a cost of $4,991,961 for 43,741 square feet, or $83,199 per bed. The services that are proposed include subacute care, a 15-bed unit for persons suffering from Alzheimer's disease and related dementias, long term care, and two pediatric beds. Respite care will also be provided. RHA proposes that its subacute care unit would provide step-down care for patients referred from acute care hospital settings. RHA also proposes to provide rehabilitative therapies to serve patients suffering from fractured hips and joint replacements as well as other patients needing more intensive physical therapy. Cardiac and respiratory patients will also be served in the subacute unit. As indicated above, there is a need for subacute nursing home beds in Orange County. RHA's proposed 15-bed Alzheimer's unit will be a distinct and secured part of the facility. The unit will have its own enclosed courtyard and activities area. As indicated above, there is a need for nursing home beds for persons suffering from Alzheimer's disease and related dementias in Orange County. RHA also proposes a program dedicated to the care and treatment of persons suffering from AIDS/HIV. This program will provide long-term care, and will include psychiatric, as well as subacute services. As indicated above, there is a need for nursing home beds for persons suffering from AIDS/HIV in Orange County. The RHA proposal includes two pediatric nursing home beds. It is not uncommon to provide pediatric nursing home beds in a small unit within a nursing home facility. These beds will provide subacute care to pediatric patients referred from acute care hospital settings. It is anticipated that the pediatric unit will serve patients with respiratory problems and other multiple system failures. RHA has experienced difficulty in placing pediatric patients discharged from Princeton Hospital. The RHA facility is designed in a series of modules. There are four patient wings located around a single nursing station. The Alzheimer's wing is distinct and secured. The pediatric beds are located in a single semiprivate room close to the nursing station. The subacute unit includes six beds with wall-mounted medical gases and vacuums. Each residential room has approximately 272 net square feet, and features its own handicapped toilet and bathing facilities. The facility includes a chapel, convenience store, laundry, ice cream shop, and beauty shop, designed in a mall concept. The corridors are ten feet in width instead of the standard eight feet. The intent of the design concept is to encourage social interaction. As designed, the location of the soiled utility room in the facility does not comply with applicable Florida code regulations; however, a proposed minor change in the design will move the soiled utility room approximately twenty feet to bring the facility into compliance with Florida code regulations. ALLOCATION FACTORS Relationship to District and State Health Plans Section 408.035(1)(a), Florida Statutes District Health Plan Allocation Factor 1 of the District Health Plan provides a priority for an applicant proposing to locate in the northwest Orange County population center. This preference will continue to be given applicants until a total of 120 beds is obtained. HCR is the only applicant proposing to locate in the northwest Orange County population center; however, in January of 1993, Sunbelt Living Center, a 120-bed community nursing home opened in Apopka, Florida, which is located in the northwest Orange County population center. Accordingly, the total bed number for this preference has been obtained, and this district allocation factor is inapplicable to these proceedings. Allocation Factor 2 of the District Health Plan provides a preference for applicants developing specific services for newborn and/or pediatric patients. RHA is the only applicant proposing specific services which include a unit for the care and treatment of pediatric patients. Accordingly, RHA is the only applicant which meets this allocation factor. Allocation Factor 3 of the District Health Plan provides a preference for an applicant proposing to develop a specific specialty service (or services), such as a unit for medically complex patients, a unit dealing with psychiatric disorders as a primary diagnosis, or services for persons suffering from AIDS/HIV. This preference is also provided to an applicant which commits to working with, or in conjunction with, an existing provider of a specialty service, such as hospices, or mental health providers. RHA is the applicant which best meets this allocation factor. The RHA proposal provides for specialty services for medically complex patients, provides for services to persons suffering from AIDS/HIV, and RHA specifically commits to working with mental health providers, including working with the psychiatric unit at Princeton Hospital. ADVENTIST and LIFE CARE also propose to provide specialty services to medically complex patients in subacute units; however, the ADVENTIST facility is better equipped in this regard and is designed with piped in medical gases, vacuum, and expanded electrical capacity will have the capability to provide more extensive services. LIFE CARE also proposes to treat persons suffering from AIDS/HIV and persons with mental disorders. The LIFE CARE proposal, however, is not as specific in this regard as that of RHA. HCR proposes to provide specialty services to persons suffering from Alzheimer's disease and related dementias, and is in general compliance with this allocation factor. State Health Plan Allocation Factors Each applicant meets the first State Health Plan allocation factor which provides a preference for an applicant proposing to locate in areas within the subdistrict with occupancy rates exceeding 90 percent. The occupancy rate in Orange County exceeds 90 percent. RHA and LIFE CARE meet the second State Health Plan allocation factor which provides a preference for an applicant proposing to serve Medicaid patients in proportion to the average subdistrict-wide percentage of nursing homes. In Orange County the average is 65 percent for Medicaid service. ADVENTIST meets this preference with regard to its non-subacute unit. HCR which proposes a 30 percent Medicaid service does not meet this preference. The third State Health Plan allocation factor provides a preference to an applicant proposing specialized services to special care residents, including AIDS residents, Alzheimer's residents, and the mentally ill. Each applicant generally complies with this allocation factor and offers specialty services; however, RHA with its broader spectrum of specialty services, including services to AIDS/HIV residents, Alzheimer's residents, and its specific commitment to working with residents suffering from psychiatric disorders best meets this preference. The fourth State Health Plan allocation factor provides a preference to an applicant proposing to provide a continuum of services to community residents including, but not limited to, respite care and adult day care. RHA and ADVENTIST best meet this preference. RHA and ADVENTIST have a history of providing quality health care service to the community. RHA and ADVENTIST have extensive ongoing relationships with acute care hospitals. HCR and LIFE CARE have also established relationships which will address providing a continuum of care, but not to the extent proposed by RHA and ADVENTIST. The fifth State Health Plan allocation factor provides a preference to an applicant proposing to construct facilities which provide maximum resident comfort and quality of care. Each applicant proposes facilities designed to provide resident comfort and quality care. Each design has comfortable resident rooms, spacious activities areas, recreation areas, courtyards, landscaping, therapy rooms, and staff lounge areas. Each applicant meets this preference. The sixth State Health Plan allocation factor provides a preference for an applicant proposing innovative therapeutic programs which have proven effective in enhancing the residents' physical and mental functioning level and which emphasize restorative care. Each of the applicants' proposals feature specific elements of innovative therapeutic programs. HCR has received an award for its innovative design of the Boynton Beach Alzheimer's unit. RHA offers a multi-discipline approach with a psychiatric program. ADVENTIST offers an intensive subacute care unit, and LIFE CARE offer a well-balanced approach with intensive staff training. The seventh State Health Plan allocation factor provides a preference for an applicant proposing charges which do not exceed the highest Medicaid per diem rate in the subdistrict. In this respect, HCR projects Medicaid charges of $96.20 per patient day in Year 1, and $93.32 in Year 2. LIFE CARE projects Medicaid charges of $104.74 per patient day in Year 1, and $106.20 in Year 2. ADVENTIST projects Medicaid charges of $106.00 per patient day in Year 1, and $111.30 in Year 2. RHA projects Medicaid charges of $107.02 per patient day in Year 1, and $109.24 in Year 2. While HCR projects the lowest Medicaid per diem charges and appears to best meet this allocation factor, all applicants have agreed to a specified Medicaid utilization rate, and will accept the appropriate Medicaid reimbursement levels. The eighth State Health Plan allocation factor provides a preference for an applicant with a history of providing superior resident care in Florida or other states. HCR has maintained superior licensure ratings, and its prototype Boynton Beach facility currently is rated superior. LIFE CARE in 1993 experienced a conditional rating for its Altamonte Springs facility; however, the facility, upon evaluation in the fall of 1994, is now recommended for a superior licensure rating. RHA does not currently operate nursing homes; however, RHA has a history of providing quality care in its Princeton Hospital. ADVENTIST is the only applicant proposing to add nursing home beds to an existing facility that currently has a superior licensure rating, and in this respect, ADVENTIST best meets this allocation factor. The ninth State Health Plan allocation factor provides a preference to an applicant proposing staff levels which exceed minimum staffing standards contained in licensure administrative rules. Applicants proposing higher ratios of RNs- and LPNs-to-residents shall be given preference. All applicants meet this factor; however a comparison of the nursing staffing patterns of the applicants reflects that HCR (45.40 nursing FTE) and LIFE CARE (45.30 nursing FTE) have a higher than the minimum required ratio of nursing staff to residents for their proposed 98-bed facilities. RHA has proposed 35.30 nursing FTE for its 60-bed facility. ADVENTIST proposes a total 62.40 nursing FTE for its facility after the proposed 38-bed addition. The tenth State Health Plan allocation factor provides a preference for an applicant who will use professionals from a variety of disciplines to meet the residents' needs for social services, specialized therapies, nutrition, recreational activities, and spiritual guidance. These professionals shall include physical therapists, mental health nurses, and social workers. All the applicants offer a wide range of social, spiritual, nutritional, and recreational services. RHA, however, also proposes specific utilization of mental health care professionals, and a specific affiliation with the psychiatric care professionals from Princeton Hospital, and best meets this factor. The eleventh State Health Plan allocation factor provides a preference for an applicant who ensures the residents' rights and privacy, and who implements a well-designed quality assurance and discharge planning program. Each applicant has documented specific plans for quality assurance and ensuring the residents' rights and privacy are protected. Accordingly, each applicant meets this factor. The final State Health Plan allocation factor provides for a preference to an applicant proposing lower administrative costs, and higher resident care costs compared to the average nursing home in the district. HCR has the lowest projected administrative and overhead costs ($18.28 per patient day as of Year 2), and best meets this allocation factor. Statutory Review Criteria, Section 408.035(1), F.S. Section 408.035(1)(b): The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, inadequacy of like and existing health care services and hospices in the service district of the applicant. HCR, LIFE CARE, and RHA each proposes a unit dedicated to the care and treatment of persons suffering from Alzheimer's disease and related dementias (HCR 98-bed facility, LIFE CARE 20-bed unit, and RHA 15-bed unit). ADVENTIST, while currently providing care for Alzheimer's patients at SLC, does not propose a distinct Alzheimer's unit in its 38-bed addition. There are currently at least five nursing homes in the service district, and two others in close proximity, which feature dedicated Alzheimer's units, with a total of at least 345 nursing home beds serving Alzheimer's patients. There is a high utilization rate of Alzheimer's nursing home beds in the district. While there is an established need for more beds to serve Alzheimer's patients, particularly Alzheimer's patients with a history of disruptive behavior, there are additional needs in the service district to provide care and treatment for subacute patients, and for persons suffering from AIDS/HIV. It is difficult to quantify the need for subacute nursing home beds due to the differing professional definitions of what constitutes subacute care; however, acute care hospitals in Orange County are, for cost-effective reasons, now releasing patients on an earlier basis, and there is an established need for nursing home beds to accommodate persons released from acute care hospitals. There is a high utilization rate of subacute beds in the district. There has also been an increase in the incidence of AIDS/HIV patients, and in the need for nursing home beds for persons suffering from AIDS/HIV in the service district. Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant's record of providing quality of care. Each applicant has the ability to provide quality of care, and each applicant has a history of providing quality of care. The distinguishing factors in this regard are that LIFE CARE is the only applicant that has experienced a downgrading of a nursing home facility from a superior to a conditional licensure rating, and ADVENTIST is the only applicant that proposes to add nursing home beds to a facility that currently has a superior licensure rating. In comparison, ADVENTIST best meets this factor, and LIFE CARE least meets this factor. Section 408.035(1)(e): Probable economies and improvements in service that may be derived from operation of joint, cooperative, or shared health care resources. ADVENTIST and RHA both have specific proposals to work with, and share services with acute care hospitals. Both are in close proximity to acute care hospitals which will expedite sharing of medical resources. RHA will also share dietary services with Princeton Hospital. The freestanding facilities proposed by HCR and LIFE CARE do not have this advantage. Section 408.035(1)(f): The need in the service district for special equipment and services which are not reasonably and economically accessible in adjoining areas. This factor is inapplicable to the proposals. No specific need was established as to special services and equipment not reasonably and economically accessible in adjoining areas. There are dedicated Alzheimer's units and dementia services for persons in adjoining areas. Section 408.035(1)(g): The need for research and educational facilities, including but not limited to, institutional training programs and community training programs for health care practitioners. RHA has an extensive proposal for the participation and training of health care practitioners in conjunction with Princeton Hospital and best meets this criterion. RHA's affiliation with the University of Florida College of Medicine, Shands Hospital, and the Brain Institute at the University of Florida enhances this proposal. ADVENTIST shares a similar educational and training relationship with Florida Hospital, and with Florida Hospital's registered nurse baccalaureate degree program through Southern College. LIFE CARE proposes to establish relationships with local community colleges and education centers to sponsor nursing programs. Section 408.035(1)(h): The availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures for project accomplishment As stipulated, each applicant meets this criterion. Each applicant also has substantial personnel and management resources available for project accomplishment. Section 408.035(1)(i): The immediate and long- term financial feasibility of the proposal. LIFE CARE, ADVENTIST and RHA meet this criterion, and reasonably project positive cash flows by the second year of operation. RHA a not-for- profit corporation, projects a net loss of $114,000 in Year 1 of operation, and an excess of revenues over expenses of $53,000 in Year 2 of operation. LIFE CARE projects a net loss of $440,496 in Year 1 and a net gain of $145,085 in Year 2 for the 98-bed facility, and a net loss of $259,971 in Year 1 and a net gain of $54,920 in Year 2 for the 60-bed facility. HCR projects an after-tax profit of $25,000 in Year 2; however, in order to attain a level of profitability HCR must meet its projected 65 percent private pay utilization. This is a very high private payor mix, and there is a significant question as to whether this payor mix is attainable in the subdistrict; however, as proposed, HCR meets this factor. Sections 408.035(1)(k)(l) and (m): Impact of the project on cost of health services; cost effective- ness; construction costs. ADVENTIST proposes the most cost-effective project by adding beds to an existing facility (SLC). The addition of 38 beds to SLC will promote and maximize the overall efficiency of the facility which was originally designed with core support features to accommodate 120 residents. The proposed 38-bed addition to SLC will also lower the costs per patient day of the entire facility. The ADVENTIST proposal adds nursing home beds at the lowest per bed cost ($36,000 per bed) of all applicants. Similarly, RHA is located on the campus of an existing acute care hospital owned by the applicant and, unlike HCR and LIFE CARE, projects no actual cash expenditure for land acquisition. Each applicant has proposed a reasonable design of its proposed facility and reasonable construction costs, and taken into consideration applicable costs and methods of energy provision and conservation. Each applicant meets this criterion. Each applicant has also proposed a very high quality of care facility that will foster competition and promote quality assurance and cost- effectiveness. Each applicant meets this criterion. Section 408.035(1)(n): The applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent. RHA, ADVENTIST and LIFE CARE have proposed providing health care services to Medicaid patients at rates at, or in excess of, the district average. HCR proposes the lowest Medicaid service rate at 30 percent. RHA also has a strong record of providing Medicaid services and service to the medically indigent at Princeton Hospital. All applicants except HCR meet this factor. Section 408.035(1)(o): The applicant's past and proposed provision of services which promote a continuum of care in a multilevel health care system. The RHA and ADVENTIST proposals best meet this criterion. Both the RHA and the ADVENTIST proposals are closely associated with existing hospitals, and emphasize a continuum of care from the acute hospital setting to a nursing home facility. The RHA and ADVENTIST proposals promote the interaction of health care professionals in a multilevel health care system. The HCR and LIFE CARE proposals do not reflect such an extensive interconnection with other aspects of the health care system, and do not promote a continuum of care to the extent proposed by RHA and ADVENTIST. Section 408.035(2)(b): Whether existing inpatient facilities providing inpatient services similar to those being proposed are being used in an appropriate and efficient manner. The evidence reflects that the existing inpatient facilities in, or adjacent to, the district which offer subacute and AIDS services, as well as services dedicated to the care and treatment of persons suffering from Alzheimer's disease and related dementias are operating at, or near, capacity, and are being used in an appropriate and efficient manner.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: RHA's application for CON No. 7538 be APPROVED. ADVENTIST'S application for CON No. 7528 be APPROVED. HCR's application for CON No. 7530 be DENIED. LIFE CARE'S applications for CON Nos. 7534 and 7534P be DENIED. RECOMMENDED in Tallahassee, Leon County, Florida, this 27th day of July, 1995. RICHARD HIXSON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1995. APPENDIX HCR's Proposed Findings 1-5. Accepted in substance. 6. Rejected, insofar as quantification of need for subacute services, while not readily ascertainable, was demonstrated by other applicants.demonstrated need existed in district 7-8. Accepted in substance. 9. See Number 6. 10-14. Accepted in substance, but disposed of by ruling in Clay County case. 15-27. Accepted in substance. 28-36. Rejected insofar as quantification of need for subacute services is not readily accessible; however, need for such services was established. Accepted, except that need for 120 beds has been met. Accepted, except that RHA proposes specific pediatric services and is entitled to preference. Accepted in substance, except last sentence is rejected. Accepted. Accepted, except that ADVENTIST meets preference as to the non- subacute unit. 42-43. Accepted in substance. 44-45. Rejected. Accepted in substance. Accepted, except that ADVENTIST and RHA also meet this factor, and ADVENTIST is adding beds to an existing superior-rated facility. 48-50. Accepted in part, other applicants meet these factors. 51-65. Accepted in substance; however other services are also needed in the district. 66-67. Rejected. 68-73. Accepted in substance. 74-76. Accepted; however other services are also needed in the district. 77. Rejected. 78-86. Accepted in substance. 87-94. Accepted only to the extent that the HCR proposal meets the minimum requirements to demonstrate financial feasibility. 95-103. Accepted in substance; however each applicant's proposal also meets this factor. 104-112. Accepted in substance. 113. Rejected. 114. Accepted; however RHA proposes a minor change to correct this design. 115-116. Accepted only as to RHA design features. 117-122. Rejected. 123-127. Accepted in substance. 128-131. Rejected. LIFE CARE's Proposed Findings 1-3. Accepted in substance. 4. Accepted, except that district plan includes consideration of pediatric population. 5-7. Accepted; however other applicants also meet these factors. See Finding No. 4. Rejected to the extent that it is not uncommon for pediatric care to be provided in a nursing home setting. 10-38. Accepted in substance. 39-40. Rejected to the extent that RHA and ADVENTIST have competitive staff salaries and have experienced no difficulty in hiring qualified staff. 41-57. Accepted in substance. 58-59. Rejected. Accepted; however RHA proposes a minor change to correct this design. Rejected. 62-65. Accepted in substance. 66-69. Disposed of by Clay County case. Accepted; however ADVENTIST meets this factor in the non-subacute unit. Accepted in substance. ADVENTIST's Proposed Findings 1-4. Accepted in substance. 5. Accepted only to the extent that HCR does not propose a specific subacute care unit. 6-13. Accepted in substance. Rejected to the extent that HCR's proposal meets minimum financial feasibility requirements. Accepted. 16-17. Rejected. Accepted. Accepted to the extent that RHA and ADVENTIST best meet this criterion. 20-21. Accepted in substance. 22-26. Disposed of by Clay County case. 27-29. Accepted in substance 30-31. Rejected. 32-35. Accepted in substance. 36. Rejected; see No. 19. 37-106. Accepted in substance. 107. Accepted; see No. 19. RHA's Proposed Findings 1-21. Accepted in substance. 22. Accepted; however other applicants also meet these factors. 23-54. Accepted in substance. 55. Accepted to the extent that there are at least seven nursing homes with dedicated Alzheimer's units in or near the service area. 56-92. Accepted in substance. 93-96. Accepted; however HCR meets minimum financial feasibility requirements. 97-102. Accepted; however LIFE CARE meets minimum financial feasibility requirements. 103. Rejected. 104-122. Accepted in substance. 123. Rejected. 124-135. Accepted in substance. 136. Rejected to the extent that all applicants have met the design criterion. 137-140. Accepted in substance. 141. Rejected. 142-145. Accepted in substance. 146. Accepted to the extent that RHA and ADVENTIST best meet this criterion. COPIES FURNISHED: Stephen K. Boone, Esquire BOONE, BOONE & BOONE, P.A. Post Office Box 1596 Venice, Florida 34284 Alfred W. Clark, Esquire 117 South Gadsden, Suite 201 Tallahassee, Florida. 32301 R. Bruce McKibben, Jr., Esquire PENNINGTON & HABEN, P.A. 215 South Monroe Street, 2nd Floor Post Office Box 10095 Tallahassee, Florida 32301 Michael J. Glazer, Esquire MACFARLANE, AUSLEY, FERGUSON & MCMULLEN, P.A. Post Office Box 391 Tallahassee, Florida 32301 Samuel Dean Bunton, Esquire Senior Attorney, AHCA Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 Steven R. Bechtel, Esquire MATEER, HARBERT & BATES, P.A. Post Office Box 2854 Orlando, Florida 32802 James M. Barclay, Esquire COBB, C0LE & BELL 131 North Gadsden Street Tallahassee, Florida 32301
