Findings Of Fact South Miami Hospital's proposed findings of fact: The following proposed findings where adopted and found as fact in the body of this recommended order, or if not explicitly found therein, are hereby adopted as findings of fact: 1, 2, 3, 4, 6 (except the first and last sentences), 7(A) through (E), 8(A) through (J)(except sentences 4 and 5 of (B) and sentence 3 of (F)), 10(except the first sentence), and 11 (except the first sentence). The following proposed findings have been rejected because the Hearing Officer has concluded as a matter of law that the rules exceed statutory authority because they preclude balanced consideration of statutory criteria, and thus the Hearing Officer has not reached the question of whether the rules are reasonably related to the purposes of the statute or appropriate to the ends specified in the statute. These proposed findings are also rejected because they are conclusions of law: 5, 6 (first and last sentences), 10 (first sentence), and 11 (first sentence). The following proposed finding has been rejected because the state agency action report for certificate of need 1244 is not in evidence, and the testimony is not adequate or not adequately supported on the point: 8(B)(sentences 4 and 5). The third sentence of proposed finding of fact 8(F) is rejected because the state agency action report was in error when it stated that seven of eleven units in Dade County were performing 6,000 procedures per year. Proposed finding of fact 9 is rejected as legally irrelevant pursuant to conclusion of law 19. The Department of Health and Rehabilitative Services's proposed findings of fact: The following proposed findings of fact were adopted and found as fact in the body of this recommended order, or if not explicitly found therein, are hereby adopted as findings of fact: 1,2,3(except the second sentence), 4, 5, 6, 8, 9, 10, 11, and 12. The following proposed finding of fact is rejected because in those instances where the 6,000 treatments threshold is not met, the existing and proposed rules preclude consideration of any other rule criteria: 7. The following proposed finding of fact is rejected because the order of consolidation only permits the record in the section 120.57 hearing to be considered in the rule challenge cases, and not vice versa: 3(second sentence). Baptist Hospital of Miami, Inc.'s proposed findings of fact: The following proposed findings of fact were adopted and found as fact in the body of this recommended order, or it not explicitly found therein, are hereby adopted as findings of fact: 1, 2 (except the last sentence), 4, 5, 6, 7(except sentences 2 and 3), 8, 9, 10, 12, 17, 18, and 19. The last sentence of proposed finding 2 is rejected. There is only perhaps one (1) free standing outpatient radiation unit in District XI, and 15 hospital-based units. TR. 72. Thus, the 90 percent of outpatient treatments must in fact be occurring in the 15 hospital based units rather than in outpatient units. Consequently, although there is no evidence of fraudulent or improper suppression of treatments in this record, the hospitals in District XI which have radiation units certainly are in a position to suppress the number of treatments if they choose to do so. Proposed finding of fact 3 is rejected. Evidence Which was presented contrary to this finding has been found in findings of fact 49, 51, 52 and 53. The second and third sentence of proposed findings of fact 7 are rejected. The Hearing Officer needed only 10 to 15 minutes to read through a state agency action report to discover to what extent HRS mentioned or considered the rule, and all of the findings herein pertaining to specific state agency action reports were compiled in that length of time per report. Further, the few mistakes made by Mr. Cushman have been discussed in findings of fact 85- 101, and the totality of those mistakes, hopefully not compounded by mistakes of the Hearing Officer, did not change the conclusions that are inescapable when from finding of fact 101. The decisional history by HRS under the rule has been arbitrary given the fact that the rule is absolute and has no exceptions. Proposed finding of fact 11 is irrelevant since the state agency action reports themselves are in evidence, and is rejected on that basis. Proposed findings of fact 13, 15, and 16 are true but misleading since the analysis in each case by HRS was not based upon consideration of the entire District, but was a finding based solely upon a subarea in the district. The essentials of these proposed findings of fact have been dealt with in findings of fact 95B and 97B, C, and D. Proposed finding of fact 14 is rejected because lacking a basis of fact in the record to make it relevant. The record contains no evidence as to any local health systems agency having subdivided a district, except for District XI, and it further contains no evidence as to why that might be relevant in evaluation of certificate of need decisions in districts other than District XI. Mercy Hospital, Inc.'s proposed findings of fact: Proposed finding of fact 1 is rejected as a proposed finding of fact because it is a conclusions of law and has been discussed in that section, to the extent relevant. The following proposed findings of fact were adopted and found as fact in the body of his recommended order, or if not explicitly found therein, are hereby adopted as findings of fact: 2(except the last sentence), 3, 5, and 6. The last sentence of proposed finding of fact 2 is rejected. The fact that the state agency action reports in some cases, as noted in finding of fact 100, mentioned that utilization rates of some or all of the units in the district does not compel the conclusion proposed that "it was in fact one of the criteria that had to be met." The Hearing Officer has read each state agency action report, and although a utilization rate may have been mentioned in the state agency action report in some cases, HRS did not state in the report that the 6,000 treatments threshold "had to be met" or that the rule was satisfied, unless mentioned in the findings above. Proposed finding of fact 4 has been dealt with in conclusions of law 18 and 19. A number of the facts contained in this proposed finding have in fact been found. But the arguments of law contained in this proposed finding of fact are either contained in the conclusions of law or are irrelevant in view of those conclusions of law. COPIES FURNISHED: John Gilroy, Esquire Dept. of Health and Rehabilitative Services Building 1, Suite 407 1323 Winewood Boulevard Tallahassee, Florida 32301 Jean Laramore, Esquire G. Steven Pfeiffer, Esquire LARAMORE & CLARK, P.A. 325 North Calhoun Street Tallahassee, Florida 32301 Lewis W. Fishman, Esquire 9400 South Dadeland Blvd. Suite 420, Dadeland Towers South Miami, Florida 33156 Kyle R. Saxon, Esquire Catlin, Saxon, Tuttle & Evans 800 Alfred I. duPont Building Miami, Florida 33131 Steven Huss, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee Florida 32301 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Liz Cloud, Chief Bureau of Administrative Code 1802 The Capitol Tallahassee, Florida 32301 Carroll Webb, Executive Director Administrative Procedure Committee 120 Holland Building Tallahassee, Florida 32301
The Issue Whether Petitioner’s request for coverage of proton beam radiation therapy (“proton beam therapy” or “PBRT”) is a covered benefit pursuant to the State Employees’ Health Maintenance Organization (“HMO”) Plan (“Plan”), administered by AvMed.
Findings Of Fact Respondent is the state agency charged with administering the state employee health insurance program pursuant to section 110.123. At all times material hereto, Petitioner was a member of the Plan. AvMed is the third-party administrator for the Plan at issue in this cause. As the third-party administrator, AvMed provides claims processing, utilization, and benefit management services. The applicable benefit document is the State Employees’ HMO Plan, Group Health Insurance Plan Booklet and Benefits Document (“Plan Document”), effective January 1, 2019. Petitioner is a 66-year-old male who was diagnosed with prostate cancer in November 2017 and underwent a prostatectomy to remove his prostate on April 12, 2018. Subsequent to his initial surgery and treatment, Petitioner experienced increasing prostate specific antigen (“PSA”) in three follow-up tests. His prostate cancer had returned. Petitioner’s physician sought to treat his condition with PBRT, a form of external beam radiation utilizing protons, rather than traditional intensity modulated radiation therapy (“IMRT”), which is, without question, covered under the Plan. Medicare, a federal healthcare insurance program, agreed to pay 80 percent of Intervenor’s charges for PBRT, leaving Petitioner responsible for the remaining 20 percent being sought to be paid by Petitioner’s Plan. On July 3, 2019, Petitioner, through his healthcare provider, Maria-Amelia Rodrigues, M.D., and Intervenor, Miami Cancer Institute, submitted a request for coverage of PBRT to AvMed. On July 10, 2019, AvMed denied the preservice request for coverage on the basis that the therapy was experimental/investigational and, therefore, not medically necessary treatment for the member’s condition. The request was reviewed by Sri Gorty, M.D., a consultant radiation oncologist at Magellan Healthcare, which is under contract with AvMed. On July 23, 2019, Petitioner submitted a request for a Level I appeal to AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant radiology oncologist at Dane Street, which is under contract with AvMed. He filed a report dated August 19, 2019. On August 20, 2019, AvMed denied the request for Level I appeal on the basis that the therapy was experimental/investigational and, therefore, not a medically necessary treatment. On November 19, 2019, Petitioner submitted a request for an “Expedited” Level II appeal to Respondent. The Level II appeal was reviewed by Dearline Thomas-Brown, a registered nurse and Level II appeal coordinator for Respondent. On November 21, 2019, Respondent denied Petitioner’s Level II appeal on the basis that the therapy is experimental/investigational and, therefore, not medically necessary for treatment of the member’s condition. Pursuant to the Plan Document, the Plan pays its share of the cost of covered services, if the services are: Ordered by a Network Provider (a provider who is in AvMed’s network); Considered Medically Necessary for the covered person’s treatment because of accident, illness, condition or mental health or nervous disorder; Not specifically limited or excluded under this Plan; and Rendered while this Plan is in effect. Pursuant to the Plan Document, Section I. Introduction: The Plan is not intended to and does not cover or provide any Medical Services or benefits that are not Medically Necessary for the diagnosis and treatment of the Health Plan Member. AvMed determines whether the services are Medically Necessary on the basis of terms, conditions, and criteria established by the Plan as interpreted by the state, and as set forth in medical guidelines. This chart provides a description of services and supplies covered under the Plan. Coverage Access Rules are specified under the Plan as follows: Cancer Services Diagnosis and Treatment Includes both inpatient and outpatient diagnostic tests and treatment (including anti-cancer medications administered by Network providers), including cancer clinical trials as set forth in the Florida Clinical Trial Compact. Does not include Experimental or Investigational Treatment. In order to be a covered benefit, the treatment must be “medically necessary,” not “experimental or investigational,” and it must not be specifically excluded by the Plan. “Medically Necessary” is defined as follows: The use of any appropriate medical treatment, service, equipment and/or supply as provided by a Hospital, skilled nursing facility, physician or other provider which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s Illness or injury, and which is: Consistent with the symptom, diagnosis and treatment of the Health Plan Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable medical practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not experimental or investigational. The service must meet all of the above-referenced criteria in order to be medically necessary. Given the above definition, if a service is experimental or investigational, then it cannot be medically necessary. Section VI. Limitations and Exclusions in the Plan Document specifically exclude services that are “experimental/investigational or not medically necessary treatment with the exception of routine care in connection with a clinical trial in cancer, pursuant to the Florida Clinical Trial Compact and the Patient Protection and Affordable Care Act.” “Experimental and/or Investigational” is defined as follows: For the purposes of this Plan a medication, treatment, device, surgery or procedure may initially be determined by AvMed to be experimental and/or investigational if any of the following applies: The FDA has not granted the approval for general use; or There are insufficient outcomes data available from controlled clinical trials published in peer- reviewed literature to substantiate its effectiveness for the disease or injury involved; or There is no consensus among practicing physicians that the medication, treatment, therapy, procedure or device is safe or effective for the treatment in question or such medication, treatment, therapy, procedure or device is not the standard treatment, therapy procedure or device utilized by practicing physicians in treating other patients with the same or similar condition; or Such medication, treatment procedure, or device is the subject of an ongoing Phase I or Phase II clinical investigation, or Experimental or research arm of a Phase III clinical investigation, or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as comparted with the standard for treatment or diagnosis of the condition in question. If any one or more of the above-cited criteria are met, then the treatment is experimental and/or investigational and is not a covered service. In making an adverse determination as to coverage in both the Level I and Level II appeals, Edwin Rodriguez, M.D. (note the slightly different spelling of Petitioner’s expert Dr. Maria-Amelia Rodrigues versus Dr. Edwin Rodriguez), and Nurse Thomas-Brown utilized AvMed’s Medical Coverage Guideline on PBRT. This coverage guideline regarding PBRT provides AvMed’s “Exclusion Criteria” explaining “PBRT is not covered, and is considered investigational, as to all other tumors not listed” in the guideline. PBRT is not an approved treatment option for localized prostate cancer under the NIA Magellan criteria. The Medical Technology Assessment Committee at AvMed drafts clinical policy guidelines and is responsible for maintaining or changing them as technology advances. AvMed’s policy on use of PBRT for the treatment of prostate cancer states that it is not medically necessary because studies have not shown clinical outcomes to be superior to conventional radiation therapy (i.e., IMRT). This policy was developed following extensive review of studies in peer-reviewed medical literature, available guidelines, technology assessments, and opinions from experts. The policy is updated on a yearly basis in order to take into consideration any new evidence. A recent review of the policy on PBRT resulted in no change in AvMed’s position on coverage for treatment of prostate cancer. The medical coverage guidelines are meant to be used in conjunction with the Plan Document to determine whether services are medically necessary and a covered benefit. Dr. Gorty, AvMed’s external reviewer from Magellan Healthcare, who was accepted as an expert in the field of radiation oncology, testified that his recommended denial of coverage of PBRT was informed by Petitioner’s medical records, Intervenor’s Letter of Medical Necessity, clinical trials, the model policy from the American Society of Therapeutic Radiation and Oncology (“ASTRO”), and the National Comprehensive Cancer Network (“NCCN”) guidelines. PBRT PBRT is a procedure that uses protons to deliver a curative radiation dose to a tumor, while reducing radiation doses to healthy tissues and organs, which results in fewer complications and side effects than IMRT. As stated earlier, Petitioner’s prostate was removed in April 2018. Thereafter, rising PSA levels indicated that he needed further treatment, and Dr. Rodrigues, a board-certified radiation oncologist at Miami Cancer Institute, became his treating physician. Dr. Rodrigues has been treating patients for 23 years, including prostate cancer patients. She was accepted as an expert in her field for these proceedings. Dr. Rodrigues determined PBRT to be the appropriate radiation treatment for Mr. Zolfaghari given his type of prostate cancer—recurrent prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs when a cancer has been treated and then reoccurs. In addition to PBRT, Dr. Rodrigues recommended, and Petitioner received, androgen deprivation therapy, generally referred to as hormone therapy, to be used in conjunction with PBRT. Dr. Rodrigues testified that the androgen deprivation therapy blocks the production of testosterone. She testified that patients with recurrent prostate cancer or certain high-risk patients have better overall survival when the two treatments are used in conjunction. As an additional aggravating factor to Petitioner’s cancer treatment, Petitioner was diagnosed with colon cancer leading to surgery in January 2020. Dr. Rodrigues testified that Petitioner’s colon cancer made his need for PBRT even more necessary, because now Petitioner is at a higher risk for adverse effects from the unwanted spread of toxicity common with IMRT. Dr. Rodrigues, as a Miami Cancer Institute physician, wrote letters requesting treatment and appealing denials of treatment as set forth above, and testified at the March 9, 2020, administrative hearing in support of Petitioner’s efforts to obtain coverage through AvMed for PBRT, which she considers to be a medically necessary treatment modality. Dr. Rodrigues was asked why she had not gone forward and provided Petitioner IMRT in order to prevent any further delay due to the passage of time from unsuccessful appeals of the denial by AvMed for the PBRT treatment of his recurring prostate cancer. She replied that she was attempting to secure a less toxic treatment modality, PBRT, for her patient who was already approved by Medicare for coverage of 80 percent of the cost of the treatment. MEDICAL NECESSITY OF PBRT VERSUS IMRT There is no dispute that IMRT is an accepted treatment modality for Petitioner’s recurrent prostate cancer, even bearing in mind his complicating factor of colon cancer surgery and treatment endured following his 2018 prostatectomy. The remaining dispute here is whether PBRT is both medically necessary and not an experimental and/or investigative form of radiation treatment. IMRT is a recognized form of treatment for Petitioner’s recurrent prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute considered only candidates for PBRT as those who would qualify for IMRT, such as Petitioner. Given the availability of another treatment option, IMRT, which is the most widely recognized standard of care within the medical establishment for the treatment of Petitioner’s condition, Respondent’s experts conclude that PBRT is not medically necessary because it is not the most appropriate level of service in this case. While PBRT has been accepted by AvMed, according to its Plan, for certain types of cancer, the insurer has not yet authorized it for the treatment of prostate cancer. This is where the semantics of the contract come into play. Petitioner and Intervenor argued that Respondent mistakenly based its denial upon a diagnosis of “localized prostate cancer” (Dr. Rodrigues’ reading of the proscription of the use of PBRT for Petitioner) rather than “recurrent prostate cancer” (not specifically proscribed by the Plan according to her reading), combined with the fact that Petitioner’s unique medical condition requires lower toxicity in the specific type of radiation used. PBRT, she testified, offers lower radiation toxicity, which will have less of a harmful effect on Petitioner’s colon and rectum as a survivor of colon cancer surgery. Dr. Rodriguez, the AvMed senior medical director, testified that studies comparing PBRT to 3-D confirming radiation or IMRT are limited. Overall studies have not shown clinical outcomes to be superior to conventional radiation therapy. In addition to the preservice and Level I appeal reviews by AvMed, and Respondent’s Level II appeal review, an Independent Organization Review (“IRO”) was conducted by a licensed radiation oncologist employed by Independent Medical Expert Consulting Services. As a result of this independent review, the Plan’s denial was upheld. Dr. Rodrigues presented studies in her testimony and a letter of medical necessity which cited the potential for favorable outcomes with PBRT. Dr. Gorty, Respondent’s expert in radiation oncology, contradicted her testimony in that many of the studies she cited noted a need for further study regarding the safety and efficacy of PBRT for treatment, and all of these studies were based upon “localized prostate cancer,” rather than “recurrent prostate cancer.” Dr. Gorty also testified that Petitioner's records indicated that his cancer was localized, although it could also be "recurrent." Dr. Gorty testified that clinical studies show no significant difference in the toxicity between IMRT and PBRT. Further, Dr. Rodriguez explained that localized cancer can be recurrent. “Localized” refers to where the cancer may be found, while “recurrent” refers to a repeat or re-occurrence of a cancer, which might return to the same location or reappear in a different location. Paragraph 15 lists the criteria to determine whether a treatment or procedure is “medically necessary” under the AvMed policy. PBRT does not meet the third criterion of the definition of “medically necessary,” as PBRT treatment of prostate cancer is not in accordance with standards of acceptable community practice. Dr. Gorty testified that AvMed medical guidelines utilize IMRT as the “next generation” treatment, rather than PBRT. Further, Dr. Gorty testified that he was aware of several recent clinical trials concerning PBRT and IMRT, and these studies do not reach a conclusion that PBRT is preferable to IMRT. PBRT does not meet the fifth criterion of the definition of “medically necessary,” as PBRT has not been approved by the appropriate medical body or healthcare specialty involved as effective, appropriate, and essential for the care and treatment of prostate cancer. PBRT is not essential for the treatment of prostate cancer. There are several treatment modalities that are generally available for the treatment of prostate cancer and, as discussed above, several of those treatment options were reasonable treatment options for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for Petitioner in this case due to, in her opinion, fewer adverse side effects of the treatment, she admitted that Petitioner is a suitable candidate for IMRT. Therefore, PBRT does not meet the sixth criterion of the definition of “medically necessary,” as it meets the definition of “experimental and/or investigational.” Specifically, criteria 2, 3, and 4 of the definition of “experimental and/or investigational” are met, which lead to the ultimate conclusion that PBRT is not medically necessary in this case. EXPERIMENTAL AND/OR INVESTIGATIONAL TREATMENT Paragraph 18 sets forth the criteria for determining whether a treatment or procedure is “experimental and/or investigational.” The second criterion from the definition of experimental and/or investigational treatment is met in this case. Insufficient outcomes data are not available from controlled clinical trials published in peer-reviewed literature to substantiate PBRT’s safety and effectiveness for treatment of prostate cancer. Dr. Rodriguez testified that there is a lack of peer-reviewed, published, randomized studies regarding proton beam therapy. Further, PBRT treatment is not the generally accepted standard of care. Dr. Rodrigues testified that only a handful of medical centers in the United States are using PBRT to treat cancer malignancies. Only two such programs are located in Florida—the University of Florida and Intervenor. Outside of Florida, only Massachusetts General and Loma Linda offer the treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred her patients to one of these other facilities for PBRT when she deemed it appropriate to do so. Current randomized trials are on-going and being published in peer- reviewed medical literature. PBRT treatment for prostate cancer is considered investigational and not a standard of care option and, therefore, not medically necessary. Nurse Thomas-Brown testified that a treatment considered experimental or investigational is, automatically, not medically necessary. NIA Magellan Clinical Guideline Number NIA_CG_124, which was developed in July 2018 for implementation in January 2019 to assist physicians in the application of treatment, states that both surgery and radiation therapy should be used to treat organ confined prostate cancer, as well as prostate cancers extended into adjacent tissues. This guideline finds that PBRT is not an approved treatment option for localized prostate cancer as studies comparing it to 3-D conformal radiation or IMRT are limited. Leading organizations, such as NCCN and ASTRO, have noted insufficient data outcomes and a need for more study of proton beam therapy, which these organizations have not yet accepted as the standard of care. PBRT also meets the third criterion of the definition of “experimental and/or investigational.” There is no consensus among practicing physicians that PBRT is safe or effective for the treatment of prostate cancer or that PBRT is the standard treatment utilized by practicing physicians in treating other patients with the same or similar conditions. Both Dr. Gorty and Dr. Rodriguez testified that proton beam therapy is experimental and investigational and, therefore, not medically necessary for all forms of prostate cancer; two additional radiation oncologists reviewed the appeal and reached the conclusion that PBRT is not medically necessary. Additionally, there was uncontroverted evidence that IMRT, not PBRT, is the standard form of treatment utilized by practicing physicians for treatment of prostate cancer. Dr. Gorty testified that AvMed approved the NIA Magellan clinical guidelines for prostate cancer, which are based on the peer-reviewed studies; and he explained three such studies. His testimony noted that the second study from the University of Pennsylvania at Baltimore, Maryland, specifically matched Petitioner’s medical condition. This study compared 307 men and their comparative toxicity outcomes of PBRT verses IMRT for post-operative sites. It concluded that future prospective investigation and ongoing follow-up will determine whether dosimetric differences between treatment with IMRT and proton beam therapy convert to meaningful differences in long-term outcomes. As part of the appeal process on behalf of Petitioner, Intervenor also requested a review by an IRO. The review was completed by a board-certified radiation oncologist, and a report was generated on January 9, 2020. The “List of Materials Reviewed” is extensive and includes Petitioner’s medical records and Intervenor’s supporting documentation. The independent reviewer upheld the denial and noted that medical necessity has not been established. The IRO states that “until the current randomized trials ongoing are published in peer reviewed medical literature, proton beam treatment for prostate cancer is considered investigational and not a standard of care treatment option.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Group Insurance, enter a final order denying Petitioner's request for coverage for proton beam therapy. DONE AND ENTERED this 4th day of May, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN 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 4th day of May, 2020. COPIES FURNISHED: Erica D. Moore, Esquire Thomas E. Wright, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed) Abolghasem Zolfaghari 10910 Southwest 140th Avenue Miami, Florida 33186 Frank A. Florio, Esquire Maria D. Garcia, Esquire Latasha Gethers Hines, Esquire Kozyak, Tropin & Throckmorton, LLP 2525 Ponce de Leon Boulevard, Ninth Floor Coral Gables, Florida 33134 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
The Issue Two issues are raised in this case. The first issue concerns the question of whether the Petitioner must seek review and permission by and from the Respondent before engaging in this project to provide inpatient radiation therapy. See Section 381.706(1)(h), Florida Statutes. If that question is answered in the affirmative, then the next question to be answered is whether Petitioner is entitled to a certificate of need to provide inpatient radiation therapy services at its hospital in Pensacola, Florida. In answering the initial question reference is made to the case of Scared Heart Hospital of Pensacola v. Department of Health and Rehabilitative Services, and Baptist Hospital, DOAH Case No. 90-3576. That reference is made because Intervenor in the present case has made a motion in limine which asserts that the Petitioner here is estopped from raising the issue of whether jurisdiction resides with the Respondent to require a certificate of need based upon the belief that DOAH Case No. 90-3576 has answered that question in the affirmative. Thus, as argued in the motion in limine, Petitioner in the present action should be barred by doctrines of collateral estoppel and res judicata from further examining that issue. Both issues are addressed in the fact finding and conclusions of law which follow, to include a ruling on the motion in limine. At the commencement of the hearing in discussing the motion in limine an examination was made of the significance, if any, of the Petitioner having failed to clearly state its opposition to the Respondent's assertion of jurisdiction over the subject matter and that party in the Petition contesting the decision on the merits to deny the application for certificate of need. Consequently, the issue of whether Petitioner has waived its right to contest the jurisdiction is also addressed in the Recommended Order.
Findings Of Fact MOTION IN LIMINE (DOAH Case No. 92-3576) On the prior occasion described in DOAH Case No. 90-3576, Petitioner had applied to Respondent for a certificate of need to institute radiation therapy services and to construct a radiation therapy facility at the campus of its hospital in Pensacola, Florida. That center was to serve inpatients and outpatients. The projected capital expenditure for that project approximated 3.7 million dollars. Petitioner contended that the radiation therapy center that would be constructed would be an extension to an existing oncology program as contrasted with the establishment of a "new service." Consistent with that position Respondent asserted that the basis for requiring a certificate of need was found in the language at Section 381.706(1)(c), Florida Statutes, which states: A capital expenditure of $1 million or more by or on behalf of a health care facility or hospice for a purpose directly related to the furnishing of health services at such facility; provided that a certificate of need shall not be required for an expenditure to provide an outpatient health service, or to acquire equipment or refinance debt, for which a certificate of need is not otherwise required pursuant to this subsection. The department shall, by rule, adjust the capital expenditure threshold annually using an appropriate inflation index. By resort to Section 381.706(1)(c), Florida Statutes, as the basis for declaring jurisdiction, the Respondent in its preliminary position did not perceive that the proposed project constituted establishment of new institutional health services or a substantial change to the existing health services, rather, it was believed to be constituted of construction costs as a capital expenditure related to the existing oncology program which expenditure met the $1 million threshold. If the basis for jurisdiction was found within Section 381.706(1)(c), Florida Statutes, then the would-be intervenor in that case, the same intervenor here, would be denied intervention. The basis for denial is found within the limitations placed upon those persons who may participate in a decision involving certificate of need for a capital expenditure as identified in Section 381.706(1)(c), Florida Statutes. That contest is between the Respondent and an applicant for the certificate. Third parties have no right to participate. On the other hand, if the basis for jurisdiction is as argued by the petition for intervention in the prior case, that basis being the jurisdiction established by Section 381.706(1)(h), Florida Statutes, then a third party health care provider in competition with the applicant seeking a certificate of need could participate in that decision. The language in Section 381.706(1)(h), states: The establishment of inpatient institutional health services by a health care facility, or a substantial change in such services, or the obligation of capital expenditures for the offering of, or a substantial change in, any such services which entails a capital expenditure in any amount, or an annual operating cost of $500,000 or more. The department shall, by rule, adjust the annual operating cost threshold annually using an appropriate inflation index. The Hearing Officer in DOAH Case No. 90-3576, heard the matter and entered his Recommended Order to resolve the right of the present intervenor to intervene in that cause. In doing so the Hearing Officer generally addressed the jurisdictional basis upon which the agency could review the application. Nothing in that process attempted to distinguish between inpatient and outpatient costs by way of a discrete analysis and allocation of those costs. Observations were made in passing concerning the aggregate amount of inpatient and outpatient costs. In particular reference was made to the capital expenditure of approximating 3.7 million dollars. No attention was given the issue of the threshold amount associated with annual operating costs identified in Section 381.706(1)(h), Florida Statutes. Factual reference to that jurisdictional amount associated with annual operating costs was left for some other occasion. The thrust in DOAH Case No. 90-3576 was to determine whether the appropriate basis for the jurisdictional claim would be found in Section 381.706(1)(c), Florida Statutes, as initially contended by the Respondent or upon resort to Section 381.706(1)(h), Florida Statutes, as contended by the petition for intervention, without a more complete analysis concerning the jurisdictional amount set out in Section 381.706(1)(h), Florida Statutes, should the hearing officer be persuaded that the latter provision constituted the grounds for review generally stated. In the factual and legal conclusions by the hearing officer in DOAH Case No. 90-3576, he determined that the project in question for inpatient and outpatient radiation therapy services constituted the establishment of new inpatient institutional health services or at least constituted a substantial change in the services that were being provided by the applicant. Thus the petition for intervention was deemed appropriate and the motion to dismiss that petition was recommended for denial. Through the Final Order which followed, with some minor modifications which have no influence on the present case, the Respondent adopted the findings of fact of the hearing officer in DOAH Case No. 90-3576, and granted the petition to intervene. The Recommended Order was entered on April 3, 1991, and the Final Order on May 21, 1991. The parties in DOAH Case No. 90-3576 did not proceed to hearing before the present case was heard. The decision by the hearing officer in DOAH Case No. 90-3576 was to defer consideration of the matter pending hearing in the present case. That choice was upon a request by all parties in DOAH Case No. 90-3576. PARTIES STIPULATIONS CONCERNING REVIEW CRITERIA The parties agree that Petitioner's Certificate of Need Application No. 6772, the present application, meets the following statutory criteria: Section 381.705(1)(c), (h), except for the third clause which is not applicable and the fourth clause which is at issue, (i), (m), except that Intervenor contends that the project costs were not properly allocated to Petitioner's Certificate of Need Application No. 6772, and (n) to Section 381.705(1). The parties also agree that the following statutory criteria are not applicable to Petitioner's application: Section 381.705(1)(e), (f), (g) and (j), Florida Statutes. Within the context of the stipulation as to criteria, the parties agree that the following issues are to be litigated: The need for the proposed project in relation to the applicable district plan and state health plan. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the service district. The availability of and adequacy of other health care facilities and services in the service district, which may serve as alternatives for the services proposed to be provided by Scared Heart Hospital. The impact of the proposed project on the cost of providing health services proposed by Scared Heart Hospital. Whether less costly, more efficient, or more appropriate alternatives to the proposed services are available. Whether existing inpatient facilities, providing inpatient services similar to those proposed are being used in an appropriate and efficient manner. Whether patients will experience serious problems in obtaining inpatient care of the type proposed, in the absence of the proposed new service. The need that the population served or to be served has for the health services proposed to be offered, and the extent to which residents in the district are likely to have access to those services. The contribution of the proposed service in meeting the health needs of members of such medically underserved groups. BACKGROUND FACTS On August 22, 1991, Petitioner gave notice that it intended to apply for the September 19, 1991, batch review cycle to initiate inpatient radiation therapy services at its Pensacola, Florida facility. That notification referred to the fact that the Petitioner was presently constructing an outpatient cancer center to provide radiation therapy services and that the anticipated opening date for that outpatient facility was December, 1991. Petitioner did apply for the September 19, 1991 batch review for initiation of inpatient radiation therapy services. At that time the construction of the outpatient radiation therapy services was proceeding. Petitioner had received a letter of non-reviewability for the construction of the outpatient cancer treatment facility on a prior date. The completion of the outpatient radiation therapy services center at the Petitioner's facility was completed and Petitioner began to provide outpatient radiation treatment in April, 1992. The cancer treatment program at Petitioner's facility is a comprehensive cancer center providing radiation therapy, chemotherapy, IV. hydration, blood transfusion, nutrition counseling, social work counseling and a library. The outpatient facility for radiation therapy is fully staffed and supplied. It was placed on the books of the Petitioner as an active asset in the year 1991. Before submitting the application for review in September, 1991 review cycle, Petitioner conferred with Respondent and was instructed to submit an application for the initiation of inpatient services and to allocate costs to the project based upon a percentage of the total facility which would be devoted to inpatient services. Through the application Petitioner noted that the total cost of the establishment of the radiation therapy services projected to open in December, 1991, was $4,124,475. Pursuant to the instruction by the Respondent $618,671 was allocated as an estimate of capital expenditures for inpatient radiation therapy services. This approximates 15 percent of patients being treated as inpatients of the total number of patients treated by radiation therapy. Generally stated, the experience of most providers is that 10 to 15 percent of radiation therapy is delivered on an inpatient basis with the balance of the radiation therapy being delivered on an outpatient basis. The allocation of capital expenditures to inpatient therapy was an artificial device mandated by the Respondent. It does not reflect the actual experience. In actuality the incremental project costs related to capital expenditures for the inpatients receiving radiation therapy are zero. The reason for this finding is based upon the fact that the equipment for providing the inpatient radiation therapy is already in place, the facility for providing that care had been constructed, there is no associated incremental depreciation for inpatient care, the project has been fully paid for from funded depreciation cash and has been placed upon the books of the facility at 100 percent of that total. In essence, the capital costs have been incurred before the advent of the inpatient radiation therapy services. Additional costs promoted by the provision of care for inpatients who receive radiation therapy at the facility would be supply expenses attributable to those inpatients and the possibility of additional salaries attributable to overtime work done by staff to serve the inpatients. These are minimal costs. Operating costs were also artificially allocated to inpatients in the application. For the first year of operation, salaries allocated to inpatient care were estimated at $64,950.00, with associated benefits at $9,898.00, other patient care expenses at $17,925.00 and depreciation in the amount of $51,135.00. Even when resort is made to this certificate the proposal to institute inpatient radiation therapy does not reach the $500,000.00 threshold in annual operating costs, in addition to having no fiscal impact by way of capital expenditures. Petitioner is a 391 bed acute general hospital located in Pensacola, Florida. The services that it provides are available to inpatients and outpatients. Among those services are an open heart facility, neonatal intensive care Level II and Level III units, and freestanding 50 bed children's hospital. The patients receiving care for cancer are provided screening programs, risk assessments, preventative education programs, diagnostic services, surgery, chemotherapy and radiation therapy on an outpatient basis. The application for inpatient radiation therapy was not favorably reviewed in the State Agency Action Report issued on or about January 8, 1992. This led to the present hearing when Petitioner contested the decision to deny the application. Intervenor and West Florida Hospital, both of Pensacola, Florida, and the same planning district where Petitioner is located, have certificates of need to provide inpatient radiation therapy. They also provide outpatient radiation therapy. The other two hospitals treat patients referred by Petitioner for radiation therapy needs. The inpatients of the Petitioner requiring radiation therapy must be transported to the other two hospitals to receive that care. The majority of those patients who are being transported are referred to the Intervenor. Pediatric cancer patients from Petitioner's facility are transported to West Florida. The patients who are transported from Petitioner's facility to the Intervenor's facility are received by the Intervenor as outpatients. When they return to the Petitioner's facility they are perceived as inpatients. Each of the other two facilities who offer radiation therapy pursuant to certificates of need have two linear accelerators to provide inpatient and outpatient radiation therapy. Petitioner seeks to have its single linear accelerator which now provides outpatient radiation therapy made available to provide inpatient radiation therapy. There are also two non-hospital based radiation therapy centers which have single linear accelerators to provide outpatient radiation therapy services. Those non-hospital based providers are located in Ft. Walton Beach and Crestview, Florida, within the same planning district that is associated with this application. REVIEW CRITERIA 1/ Section 381.705(1)(a), Florida Statutes, requires that an application be reviewed for its consistency with the state and district health plans. Neither of those plans addresses the provision of radiation therapy services. As a consequence, neither plan sets forth need allocation factors that would address this type application. In view of the silence of the state and local health plans concerning inpatient radiation therapy, the application cannot be seen as inconsistent with those plans. Section 381.705(1)(b), Florida Statutes, speaks in terms of the availability, quality of care, efficiency, appropriateness, accessibility, and extent of utilization and adequacy of like and existing health care services in the service district to be served by the applicant. As stated before inpatient radiation therapy is being delivered by two other providers. Those providers make available and could continue to make availability the quality of care, which is efficient, appropriate, accessible and adequate in delivering inpatient radiation therapy to those patients which Petitioner would serve if granted the certificate of need to do so. The inpatient radiation therapy services offered by those two providers are not over-utilized at present nor would they be in the foreseeable future. The exception to these findings would be related to a quality of care issue not pertaining to the actual delivery of radiation therapy to patients referred from the Petitioner to the other two providers but related to the inconvenience in preparing those patients for transport for delivery of therapy and the transport itself. For some patients who are required to undergo the preparation for transport and transport, that process can be quite painful. Patients have refused to be transported to receive radiation therapy and this has complicated their treatment. It would be a less uncomfortable process if the patients were undergoing the radiation therapy at the Petitioner's facility. Physician's practice patterns in this community where some physicians choose to practice in a single hospital notwithstanding their admission privileges in multiple hospitals complicates the issue in that a patient may be admitted to Petitioner's facility because the admitting physician chooses to practice there alone. Once a diagnosis is made and a decision reached that the patient in that hospital needs to undergo radiation therapy, the need to transport for those treatment ensues. Moreover, as suggested, the decision to utilize radiation therapy in the treatment is not ordinarily made at the initial moment of admission when health care professionals are trying to make the initial diagnosis concerning the patients complaints in deciding whether they are associated with cancer or not and if radiation therapy would benefit the patient or even in the instance where the patient is known to have a history of that illness whether radiation therapy is indicated. Therefore, there might not be a reason to try and place the patient in a facility that has inpatient radiation therapy available if that treatment regime upon evaluation does not seem indicated. The issue concerning the ability to transfer a patient from one facility to another for the overall hospitalization to include provision of inpatient radiation therapy such that a patient who has been determined to need radiation therapy could be transferred from Petitioner's facility to Intervenor's facility for overall care, while theoretically possible does not seem practicable. Additionally, the patients who receive outpatient radiation therapy through Petitioner's facility who would need at some future point in treating the condition to be transferred to another facility to receive radiation therapy once admitted as an inpatient in Petitioner's facility breaks the continuity of the management of the care by requiring the patient to undergo an evaluation by two different radiation therapists, disrupting the patient- physician relationship in a setting which is complicated by the patient's condition. Nonetheless, the quality of care is not so compromised by the need to transport for the inpatients at the Petitioner's facility to receive radiation therapy to conclude that it constitutes a reason standing alone to grant the certificate of need. In a similar vein, as contemplated by Section 381.705(1)(d), Florida Statutes, the availability and adequacy of other health care facilities and services and hospices in the service district of the applicant, such as outpatient care and home care services, which might serve as alternatives for the applicant's proposal have been considered. Out of that list, only the possibility of the use of outpatient care provided by the existing facilities who offer outpatient radiation therapy would arguably have pertinence to this inquiry. They would not constitute an available and adequate substitute for inpatient radiation therapy for reason that patients who are admitted to a hospital are distinguished from those who come to the facility from other places for purposes of receiving outpatient radiation therapy. That distinction has to do with the gravity of the condition of the patient which caused the patient to be admitted to the hospital in the first instance, and to receive, together with medical attention and other therapies, the provision of radiation therapy. Concerning that portion of Section 381.705(1)(h), Florida Statutes, which describes the applicant's need to address the availability of alternative uses of resources for the provision of other health services, that clause was referred to as an issue in the prehearing stipulation but was not advanced at the hearing. Through the prehearing stipulation the parties did not include reference to Section 381.705(1)(k), Florida Statutes, as a provision about which there was an agreement concerning compliance or the need to comply with its terms. The record reveals that the applicant and the existing providers address the need for radiation therapy of individuals who are not residing in the service district. This project does not appear to have a pronounced influence in improving or diminishing health care for persons not residing in the service district. Section 381.705(1)(l), Florida Statutes, addresses the probable impact of the project on the cost of providing health services proposed by the applicant and it takes into consideration the effects of competition on the supply of health services being proposed and any improvements or innovations in the financing and delivery of health services which foster competition and serve as a promotion of quality assurance and cost effectiveness. Whether the applicant delivers services to the inpatients that it would gain with recognition of its application or some other entity serves the needs of those patients, the basic costs of providing health services would be relatively the same. The exception is the improvement in the circumstance of health care costs related to the transport of the patients from the Petitioner's facility to the two other facilities for provision of the radiation therapy of inpatients in the Petitioner's facility and the attendant costs of duplication of patient charges and professional fees charged by the physician therapist potentially associated with having a patient move from the status of an outpatient at the Petitioner's facility to an admitted patient at that facility who receives radiation therapy at one of the other two facilities while undergoing inpatient care in the Petitioner's facility. These additional costs in transport and potential for patient charges associated with procedures in the other two hospitals and physicians fees in those other two hospitals which are duplicative of efforts made by the Petitioner's outpatient radiation program in its procedures and the physician's fees associated with those outpatient radiation therapy procedures could be done away with if the project were approved. There is no indication of any significant improvements or innovations in the financing and delivery of health services associated with this application which might foster competition and serve to promote quality assurance and cost effectiveness. The cost improvements that are discussed here standing alone do not justify the applicant being granted a certificate of need. The advent of an inpatient radiation therapy service will not be so adverse in its impact that it will cause the Intervenor or any other existing facility to lose financial viability concerning the ability to maintain an appropriate level of utilization of existing facilities. There are no costs of construction and the method of proposed construction need not be considered in that the construction has been concluded as previously discussed. Consequently, the necessity to address the costs and methods of the proposed constructions as described in Section 381.705(1)(m), Florida Statutes, is not relevant to the inquiry. Nor are the references within Section 381.705(2), Florida Statutes, having to do with capital expenditures pertinent to the outcome in examining the review criteria. LACK OF A VIABLE NEEDS FORMULA Respondent does not have a rule which calculates the need for inpatient radiation therapy by resort to a formula which derives need. Neither does the Respondent have an emergent policy which it is developing to formulate the amount of inpatient radiation therapy services needed in a given review cycle. Respondent and the private litigants have attempted to examine the need for inpatient radiation therapy contemplated by this application by devising various mathematical formulas to determine need. Each explanation is fundamentally flawed in that they fail to address the discrete issue contemplated for examination by the review process, that is the need for inpatient radiation therapy. Instead, these methods look at all radiation therapy both inpatient and outpatient. The statute does not contemplate that form of evaluation. It is the 10 to 15 percent of all radiation therapy patients that constitute the inpatients. It is the provision of care to those persons that is subject to examination. If need is to be derived by use of a formula, a knowledge of the circumstances existing for outpatients, a category of patient for whom no certificate of need must be obtained to serve them, should not enter in to the analysis. The formulas exercised by the parties in measuring the overall need for inpatient and outpatient radiation therapy services derive the answers by identifying the number of linear accelerators needed in the district or in one instance for the applicant's facility alone. In that exercise a count is made of the four linear accelerators in the district belonging to the two hospitals which have been granted certificates of need which would allow inpatient radiation therapy to be delivered as well as outpatient therapy and the three programs that serve outpatients on three additional linear accelerators. The total number of linear accelerators is seven counting the linear accelerator the Petitioner has to serve outpatients. No attempt by formula has been made to ascertain whether more than four linear accelerators found within the two hospitals who have certificates of need to provide inpatient radiation therapy service are warranted. Thought provoking questions have been raised by the several parties in critiquing the needs calculation made by an opponent or opponents. However, it is not necessary to choose among these competing theories because in selecting any theory one cannot derive the amount of inpatient radiation therapy services needed in the district. Furthermore, case law does not allow the trier of fact to utilize the basic information provided by the parties to construct a formula for determining need for inpatient radiation services independent of the efforts of the parties in the person of their experts whom they have consulted with on this subject. This means that the decision here must be made by a review of applicable criteria without resort to a preliminary determination of numeric needs. This has been done. On balance, when taking into account the combination of improvements to quality of care for a patient being transported from the Petitioner's facility to receive radiation therapy and the improvement concerning the removal of the cost of that transport and duplication of charges and fees for certain patients who move from an outpatient posture under treatment by the Petitioner and into an inpatient status with Petitioner receiving radiation therapy at one of the two other hospitals which has been discussed in preceding paragraphs, the project is justified and the application should be granted.
Recommendation Based upon the consideration of the facts, and in view of the conclusions of law, it is, RECOMMENDED: That a Final Order be entered which declines jurisdiction to require a certificate of need for inpatient radiation therapy services or in the alternative grants a certificate of need for inpatient radiation therapy services. DONE and ENTERED this 20th day of August, 1992, in Tallahassee, Florida. CHARLES C. ADAMS, 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 20th day of August, 1992.
Findings Of Fact In October 1985, Dennis J. Donegan, Petitioner, qualified for and took the examination for medical technologist in hematology. He passed the examination and was subsequently so licensed. Effective January 1, 1986 new rules were adopted increasing the requirements for eligibility for applicants to take examinations in the various fields of medical technologist specialties. Although this rule was adopted by Respondent after complying with the procedural requirements for adopting rules, Petitioner was not personally notified of the change and was unaware of the increased requirements until his application to take the fall 1986 examinations in chemistry and microbiology specialties was denied. By letter dated August 27, 1986 Respondent denied the application because Petitioner did not meet the education requirements established by the rule which became effective January 1, 1986. Petitioner contends that had he known of the proposed rule change he would have applied and sat for all of the various laboratory technologist specialty examinations before the rule change became effective. Petitioner further contends that under Rule 10D-41.69(6) he is qualified to sit for the examination by reason of being an applicant who was qualified to sit for an examination prior to January 1, 1986.
Findings Of Fact By application dated July 20, 1995, Petitioner applied to Respondent for a Clinical Laboratory Supervisor's license. Petitioner has not earned a doctoral degree in clinical laboratory science, one of the specialty areas, or one of the chemical or biological sciences. Petitioner does not have a masters degree in clinical laboratory science, one of the specialty areas, or one of the chemical or biological sciences. Petitioner does not have a baccalaureate degree in medical technology, one of the specialty areas, or one of the chemical or biological sciences. Petitioner does have a baccalaureate degree in business administration and has taken college level courses in biology, human anatomy and chemistry. Petitioner has demonstrated that she has five years of pertinent experience following receipt of the degree. Accompanying her application for licensure, Petitioner presented documentation that she completed an advanced clinical practicum as a Specialist in Blood Bank Technology in 1995 and has been certified by the national Board of Registry in Chicago, Illinois. Petitioner did submit an evaluation of her college transcript by a qualified staff member of the Board of Registry, Chicago, Illinois. Petitioner did not submit an evaluation of her college transcript by a Chairperson of a chemical or biological science department of a regionally accredited U. S. college or university. Petitioner did not file a motion for an extension of time in which to submit an evaluation of her college transcript prior to the expiration of the thirty day extension period.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying Petitioner's application for licensure as a Clinical Laboratory Supervisor. DONE AND ENTERED this 27th day of August, 1996, in Tallahassee, Florida. DANIEL M. KILBRIDE, 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 August, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 96-2187 Petitioner's proposed findings of fact. Petitioner did not submit proposed findings. Respondent's proposed findings of fact. Accepted in substance: paragraphs 1,4,5,6,7,8,9,10. Rejected as subsumed or irrelevant and immaterial: Paragraphs 2 (see Preliminary Statement) and 3 (see preliminary statement). COPIES FURNISHED: Lealand L. McCharen Assistant Attorney General Office of the Attorney General The Capitol, PL-01 Tallahassee, Florida 32399-1050 Diane Orcutt, Executive Director Board of Clinical Laboratory Personnel Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Mary Donna Lee, pro se 2544 Robert Trent Jones Drive Apartment Number 816 Orlando, Florida 32835
The Issue This is a bifurcated proceeding in which the sole issue before the hearing officer at this present stage of the proceeding concerns whether the construction of a radiation therapy center and the institution of Radiation Therapy Medical Services by Sacred Heart Hospital should be considered a "new institutional health service" pursuant to Section 381.706(1)(h), Florida Statutes, as that relates to the right of Baptist Hospital to intervene in this proceeding. If the project is deemed to be merely a capital expenditure of a million dollars or more and reviewable only for that reason pursuant to Section 381.706(1)(c), Florida Statutes, then the Intervenor would have no standing as stated in Section 381.709(5)(b), Florida Statutes.
Findings Of Fact Radiation oncology is a therapeutic process in which external radiation beams are utilized to treat cancerous tumors to effect a cure or a palliation. Radiation therapy is provided by board certified radiation oncologists in specialized facilities which house radioactive materials and specialized equipment, such as linear accelerators. The provision of radiation therapy requires specialized medical personnel such as technicians certified to operate linear accelerators to provide radiation treatments, as well as physicians and dosimetrists to calibrate machines and insure that radiation treatments are properly delivered. Radiation therapy is a medical specialty which deals with the utilization of radiation for the treatment of cancerous tumors and sometimes benign diseases. Radiation oncology or radiation therapy involves the use of consultative services, the knowledge of clinical, biological and pathological characteristics of the disease process, the evaluation of patients, the localization of tumors, the planning of radiation, the delivery of radiation treatments, and subsequent evaluation of the effects of treatment on the tumor and the patient. Sacred Heart provides cancer therapy through surgery and medical oncology. The various aspects of those cancer treatment services do not include the provision of radiation therapy, although in the past, in several isolated instances, radiation oncology trained physicians have provided brachytherapy involving the implanting of radioactive materials in the tissues or body cavities of the patients involved. These instances did not involve a regular program of radiation therapy provided by Sacred Heart, however, and in the typical instance, any cancer patients needing radiation therapy, including brachytherapy, are and have been referred out to facilities offering such services, including the Intervenor. The present cancer therapy services offered by Sacred Heart are delineated on pages 55-60 of the transcript of this proceeding. Sacred Heart filed an application for a certificate of need (CON) for a radiation therapy center on its campus to serve inpatients and outpatients. The total project costs for constructing the building and equipping as a radiation therapy center is estimated to be approximately 3.7 million dollars. The applicant proposes that the radiation therapy center would be an adjunct or extension of the hospital's existing oncology program and would not constitute a "new service" as defined in Chapter 10-5, Florida Administrative Code. The Department also takes the position that the initiation of radiation oncology or therapy services is not the establishment of a "new institutional health service" or a "substantial change" in health services. The Department takes the position that the project and application is reviewable only for the construction costs portion of the project as a capital expenditure in excess of one million dollars. HRS maintained at hearing that it has consistently taken the position that radiation therapy is not considered to be a new inpatient institutional health service pursuant to subsections 381.702(8)(13), Florida Statutes (1989). The Department's representative who testified was unable to explicate the reason for the alleged determination by the Department that radiation therapy is not a new institutional health service. She was unable to relate when such a supposed policy of treating radiation therapy only as a capital expenditure was adopted by the Department. It is noteworthy when reviewing her testimony, appearing at page 88 through 126 of the transcript of this proceeding, that repeated references are made by the HRS witness, the overall tenor or theme of which is that the purchase of linear accelerators is not regarded as the effectuation of a new institutional health service according to her view of the Department's policy regarding radiation therapy. Thus it may be that the Department views the addition of radiation therapy as involving simply the purchase of capital equipment, i.e., a linear accelerator. The evidence reflects otherwise however. The institution of radiation therapy at a hospital involves much more than the mere purchase of a linear accelerator device. It involves the purchase of the accelerator, the construction of a shielded space or building in which to house it and operate it, the employment of physicists, dosemetrists, qualified radiation therapy oncologists, and even the institution of a machine shop to make repairs and repair parts. The institution of radiation therapy at a hospital involves much more than the mere purchase and installation of a linear accelerator and the instant application seeks to institute such a comprehensive therapy service and not merely the capital expenditure required to purchase a linear accelerator solely. Thus, the Department's purported policy of viewing the institution of radiation therapy service as merely a capital expenditure (if, indeed, a policy, which was not proven in this case) is misplaced because the evidence in this record reveals that institution of radiation therapy at a hospital involves much more in the way of equipment and services than the mere purchase and capital expenditure related to acquisition of a linear accelerator. The Department has reserved Rule 10-5.011(1)(g), Florida Administrative Code, for a radiation therapy methodology. The remainder of that rule contains methodologies reserved for other services which HRS regulates as new institutional health services as well. These include such services as medicare, certified home health agencies, cardiac catheterization programs, and open heart surgery services. The reservation of a radiation therapy methodology in the rules is significant because of its indication of what the Department's intent with regard to the regulation of this service is or might be, because the Department has deleted references in its rules to reservations for services it has since chosen to deregulate, such as computerized tomography and chronic renal dialysis (see former Rules 10-5.011(1)(c) and (1)(h). The elimination of these rule reservations was published in the Florida Administrative Weekly, Vol. 15, No. 27, July 7, 1989. The Department in the past has had a rule governing need methodology for radiation therapy services. That rule was in effect until late in 1985 when it was invalidated in a 120.56 Florida Statutes rule challenge proceeding in South Miami Hospital v. Department of Health and Rehabilitative Services, 7 FALR 5491 (DOAH Nov. 1985). After that rule methodology for radiation therapy services was invalidated, the Department's witness in this proceeding, in her supervisory capacity, signed a memorandum regarding reconsideration of certificate of need #2682 involved in the South Miami Hospital case wherein South Miami Hospital sought to initiate radiation therapy services. That memo stated: The Department does not currently have a rule in place to determine the need for radiation therapy, as such the reconsideration of CON #2682, utilizing statutory criteria, will consider an applicant's specific justification for the purchase of major medical equipment and the initiation of a new service (emphasis added). The Department subsequently reiterated that the establishment of a radiation therapy service would be reviewed as a new institutional health service in the case of Bayfront Medical Center v. Department of Health and Rehabilitative Services, DOAH Case No. 87-2029 (Final Order entered September 1988). In adopting the hearing officer's conclusions of law from the recommended order in that case concerning the need for review of St. Anthony's Hospital's CON application for a radiation therapy service the Department determined that, as did the hearing officer: A certificate of need is required when a hospital proposes a capital expenditure over a threshold amount to provide inpatient health services or proposes a substantial change of inpatient institutional health services. Section 381.706(1)(c) and (h), Florida Statutes, (1987). Since the application under consider- ation in this proceeding proposes radiation therapy services to inpatients, as well as outpatients for a total project cost of almost 4.2 million dollars, a CON is required. The Department failed to explain any reasonable basis for any proposed change in the policy explicated in the May 22, 1986 policy memorandum, quoted above, and in the final order in Bayfront Medical Center supra. The Department's position may be summed up to the effect that its policy has changed from one of considering radiation therapy to be a new institutional health service to the current alleged policy of considering it to be a capital expenditure. It did not explicate why that policy had changed or a rational, factual or legal basis for it however and in view of the totality of Ms. Dudek's testimony it seems that the Department witness was emphasizing the policy of referring to the addition of radiation therapy as reviewable as merely a capital expenditure because of the Department's view, apparent from her testimony, that it in essence involves purchase of a linear accelerator. In the face of the unrefuted evidence to the effect that much more in the way of equipment, services and staff is involved in adding radiation therapy to the range of services offered by a hospital, it is apparent that the Department has failed to explicate a rational basis for the putative policy of regarding the institution of such a health service as merely a capital expenditure. Baptist Hospital operates a radiation therapy center of its own of approximately 10,000 square foot space. This area contains shielded space for linear accelerators, examination rooms, physicians offices, as well as a machine shop for repair and maintenance of the linear accelerators and space for dosimetry computers. This department at Baptist is organized and operated separated from other oncology services. Radiation therapy is primarily used to treat cancer patients and the patients are seen, evaluated, and treated within the confines of the radiation therapy facility. Policies and procedures unique to the radiation therapy department are utilized. Staff members include, physicians, technicians, physicists, and dosimetrists who are dedicated only to the provision of the radiation therapy service at the hospital. Thus from a clinical perspective, therapy is not merely an extension or an adjunct of the existing oncology program but rather is a separate therapeutic service in and of itself to which oncology patients may be referred when the services are deemed needed. Indeed, oncology involves different forms of curative and palliative treatment, including surgery and chemotherapy, with much different protocols, differently trained specialized staff members, differently trained and/or certified physicians with different methods, therapies and protocols for treating cancer. The commonality between the two types of service is that they have the ultimate goal of treating cancer patients, but the evidence shows that they are clearly two different medical specialties and institutional health services. There is little relationship between radiation oncology and the field of diagnostic radiology. Diagnostic radiology services are utilized almost exclusively to diagnose illnesses, conditions, while radiation oncology or radiation therapy is used to therapeutically treat patients with radiation to effect a cure or palliation. Radiation oncologists consult with and exchange patients with general surgeons, ear, nose and throat specialists, and other specialists as they do with medical oncologists. Therefore medical oncology and radiology are separate and distinct services. Although there is a relationship between radiation oncology and other cancer services such as chemotherapy and surgical therapy, the relationship is different in terms of the unique services, equipment and specially trained personnel required to provide radiation therapy as opposed to differently trained personnel, different equipment, therapy and procedure protocols required for other types of cancer services. Thus from a health planning perspective it does not logically follow that because a hospital provides medical or surgical oncology services, that it should also provide radiation therapy. The issue of the need for the service in terms of patient demand, availability of the specially trained personnel, the costs of providing the service, including the financial feasibility of constructing the facilities and buying the equipment needed, as well as the impact on other providers in terms of diversion of available patient days must be considered. It is noteworthy, as a corroborative aside concerning the evidence that establishes that radiation therapy is a separate and distinct institutional health service, that 29 of the 33 states which have certificate of need programs for the regulation of acute care facilities require a separate certificate of need in order to establish a radiation therapy service program. Sacred Heart does not currently have a radiation therapy service. It does have oncology services and surgical services that includes surgical therapy for cancer patients. Patients who need radiation therapy currently are referred out to other facilities including Baptist Hospital. Sacred Heart attempted, in its case in support of the HRS position treating this as merely a capital expenditure situation, to analogize the provision of radiation therapy services to the acquisition of a lithotripter. Sacred Heart contends that lithotripsy which is a form of treating kidney stones is an extension of the urology program of a hospital and that radiation therapy, a form of treating cancer tumors is merely an extension of an overall integrated cancer treatment program. However, whereas the residency requirement for radiation therapy or oncology is four years, after at least one year of post-doctoral work, the specialized training necessary to perform lithotripsy is a specialty training course of only several weeks duration. Further, hospitals requiring lithotripters typically have urologists treating kidney stones on the hospital staff. Sacred Heart in this instance has no radiation oncologist on its staff acting with admitting privileges who could provide radiation therapy services at the present time. Although it may have medical oncologists and surgeons on staff who treat cancer patients, Sacred Heart lacks the specialized policies and protocols, equipment, shielded physical space, specially trained medical personnel such as radiation oncologists, dosemetrists and physicists necessary to provide radiation therapy absent to the establishment of a new service. The list of institutional health services for which there is a specific need methodology includes, among others, inpatient cardiac catheterization, open heart surgery, neonatal intensive care units and transplant programs. The Department's attempt to distinguish between the establishment of an inpatient cardiac cath service and an inpatient radiation therapy service by stating that HRS had a rule methodology for the establishment of inpatient cardiac cath services whereas it didn't for inpatient radiation therapy services is a distinction without any logical basis. This is because the establishment of a service such as radiation therapy as a distinct and separate institutional health service depends upon the factual uniqueness or differences in the equipment, staff, protocols and policies required to institute such a service, as compared to other existing services at such a hospital, rather than the mere fact that the Department in the past has chosen to have a rule methodology for one type of service and not for another one. This distinction cannot serve as the basis for establishment of HRS's intent or policy in this regard in any event, however, because HRS has at least reserved Rule 10-5.011(1)(g), Florida Administrative Code for a radiation therapy methodology in any event, it simply has not enacted one yet, thus belying any distinction in terms of its body of rules, regarding different institutional health services based upon the mere fact that it has enacted a rule methodology for determining need for one type of institutional health service and not for another as yet. In summary, although the Department and Sacred Heart attempt to distinguish between radiation therapy and other institutional inpatient health services such as open heart surgery and cardiac catheterization by contending that radiation therapy is not a specialized service, in reality it has been established that radiation therapy requires a separate facility with specialized equipment, specially trained medical personnel with different training from personnel devoted to other types of cancer services, different protocols and procedures. It thus cannot be found to merely be an adjunct or extension of other cancer services, but rather is a separate and distinct institutional inpatient health service, just as open heart surgery, cardiac catheterization, diagnostic radiology or medical oncology for instance.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the candor and demeanor of the witnesses and the pleadings and arguments of the parties it is therefore recommended that the motion to dismiss the petition to intervene filed by Baptist Hospital be denied, that Baptist Hospital be accorded standing in this proceeding and that the case proceed to hearing on the substantive merits of the application. RECOMMENDED this 3rd day of April, 1991, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of April, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-3576 Petitioner's proposed findings of fact: Accepted. Accepted, but subordinate to the Hearing Officer's findings of fact on the subject matter. 3-6 Accepted. Rejected as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted. Rejected as immaterial in this de novo proceeding. 10-20 Accepted. 21-22 Accepted, but not itself dispositive of material issues. 23-24 Accepted. 25-26 Accepted, but not materially dispositive. Accepted, but subordinate to the Hearing Officer's findings of fact. Accepted, but not materially dispositive. Accepted, but not material. Rejected as subordinate to the Hearing Officer's findings of fact. Rejected as irrelevant. Rejected as immaterial. Rejected as subordinate to the Hearing Officer's findings of fact and as immaterial. Rejected as subordinate to the Hearing Officer's findings of fact on the subject matter. Accepted, but not materially dispositive. Rejected as subordinate to the Hearing Officer's 'findings of fact and as contrary to the preponderant weight of the evidence. 37-41 Rejected as a discussion and recitation of testimony and not fact finding and as subordinate to the Hearing Officer's findings of fact. Intervenor's proposed findings of fact: 1-18 Accepted. COPIES FURNISHED: Stephen Ecenia, Esquire Katz, Kutter, Haigler, Alderman, Davis, Marks & Rutledge, P.A. 215 S. Monroe Street Suite 400 First Florida Bank Building Tallahassee, FL 32301 Karen O. Emmanuel, Esquire Emmanuel, Sheppard & Condon 30 South Spring Street Post Office Drawer 1271 Pensacola, FL 32596 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 2727 Mahan Drive, Suite 103 Fort Knox Executive Center Tallahassee, FL 32308 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Linda Harris, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
Findings Of Fact At some time prior to August 14, 1986, the Petitioner herein, Marilyn L. Edwards, submitted an application for examination for licensure as a technologist in Florida under the provisions of the Florida Clinical Laboratory Law, Chapter 483, Florida Statutes. Petitioner's application was reviewed in the Office of Licensure and Certification of DHRS by Mr. George S. Taylor, Jr. Assistant Administrator of the Laboratory Personnel Licensure Section. The criteria for licensure as a technologist are outlined in Section 10D-41.69, Florida Administrative Code, which provides that the applicant must have one of the following: A bachelor's degree, from an accredited college or university in an approved Medical Technology Program, or 90 semester hours at an accredited college or university in addition to one year in an AMA approved school of medical technology, or A bachelor's degree from an accredited college or university in one of the chemical, physical, or biological sciences with one year laboratory experience at the technician level, or An associate degree or 60 semester hours at an accredited college or university in an approved Medical Laboratory Technician Program which includes 8 hours in chemistry and 8 hours in biological science, or 60 semester hours at an accredited college or university including 20 hours of science of which at least 8 hours is in chemistry and 8 in biological science plus 4 years experience as a chemical laboratory technician. Petitioner's application was filed under the provisions of Rule 10D- 41.69(4), Florida Administrative Code, above. However, Petitioner did not meet that criteria. The school at which she was trained a program administered by the Veteran's Administration, (VA), Hospital in Dublin, Georgia, was not an accredited college as required. Ms. Edwards attended a VA certified laboratory assistant program in Dublin, Georgia, approved by the American Society of Clinical Pathology during 1970 and 1971. After graduating from that program, she took and passed the technician's examination in Florida. The course work included in the VA program included 1388 of classroom hours of course work which have not, to this date, been converted to equivalent credit hours. The course work did, however include such subject matters as anatomy, organic and inorganic chemistry, hematology parasitology, microbiology, urinalysis coagulation, and aminohematology. Ms. Edwards contends that according to the current schedule of Miami-Dade Community College the above courses make up the course work for the Associate degree in technology and in addition to the above, Ms. Edwards did her practicals, which included phlebotomy training, at the VA Hospital in Dublin. Ms. Edwards has had fourteen years of training and experience in the medical technician field. Based on the course work taken and her fourteen years experience, she contends she meets the criteria for examination. It is her opinion that the agency, in denying her application for examination, has failed to consider the years of experience she has and it is her contention that some of the programs approved by the agency are not as thorough in the laboratory sciences as that which she took. Ms. Edwards feels she has the knowledge to be a technologist, but admits the rules currently existing prohibit her certification because of the fact that she does not have the required course work at an approved college or university. The American Medical Association approves various types of allied health education and three types of medical technology education which are referenced in the agency rule. These are: Medical technologist (a four year degree program from an accredited academic institution), A medical laboratory technician associate degree program offered by various community colleges (This is very similar to and generally geared to the technician levels but there is more academics involved than for the technician certification. This second pathway meets the academic requirements for certification.), and A one year medical laboratory technician course (not referenced for technologist licensure but for technician only). There is a difference between a technician and a technologist. The former can perform with supervision and undertake tasks requiring limited judgment. The latter may work independently without supervision. Petitioner is already designated as a medical technician. In her application, according to the agency, Petitioner submitted evidence of a course of training for a technician in order to be certified as such. She also submitted the same educational background with her application for licensure as a technologist. The Veteran's Administration Hospital's course is not accredited for college credit. Even though she applied under Section (4) of the rule, she could be considered under Subsection (5) which calls for 60 semester hours plus 20 hours of scientific courses in biology and chemistry, along with four years clinical laboratory experience. Petitioner has the clinical laboratory experience and has taken some courses, but she is not considered as meeting the academic requirement because the institution where her educational courses were taken is not an accredited academic institutions as outlined in the Education Directory published by the National Center for Education Statistics sponsored by the United States Department of Education. As a result, the courses she took do not qualify as college academic courses at the technologist level. DHRS does not establish equivalent course work. The 1388 hours of classroom work taken by the applicant are not semester hours. Though Mr. Taylor said that if she had an accredited junior college or other academic institution translate the equivalents within its degree program and give her academic credit for them and if it is determined by the institution that her course work is equivalent to the required 60 hours for licensure, Petitioner will be permitted to sit for the examination, this really cannot be done. The equivalents outlined in the rule refer to equivalent courses that is semester hours to quarter or trimester hours - not equivalent institutions.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Lawn it is, therefore: RECOMMENDED that Petitioner, Marilyn Edwards, be denied examination for 1icensure as a certified laboratory technologist in Florida based on her current educational background. RECOMMENDED this 23rd day of July, 1987, at Tallahassee Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of July, 1987. COPIES FURNISHED: Sam Powers, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee Florida 32399-0700 Marilyn L. Edwards 2300 Northwest 94th Street Miami, Florida 33147 Leonard T. Helfand Esquire Department of Health and Rehabilitative Services 401 Northwest 2nd venue, Suite 1040 Miami, Florida 33128
