Findings Of Fact Respondent, Mary-Claire Chapman, M.D. (Dr. Chapman) is now, and at all relevant times was licensed as a physician in the State of Florida, having been issued license number ME 0049241. From May 1989 until May 1992, Dr. Chapman was the chief health officer at Charlotte Correctional Institution (CCI), a prison in the Florida correctional system, in Punta Gorda, Florida. Patient A.J. Inmate A.J. arrived at CCI on August 9, 1989, with no apparent medical complaints. From August 1989, until March 1990, he attended sick call or clinic with complaints related primarily to digestive disorders; the treatment given to him during that period is not at issue. A.J.'s first noted complaints of headaches was on March 8, 1990, when he was seen at Doctor's Clinic at CCI by staff physician, Dr. DeCespedes. He was given Motrin. On March 10, A.J. completed an inmate medical request seeking to have his eyes checked as he stated he was getting daily headaches for three weeks. He was seen in sick call on March 12, with complaint of "severe migraine headache" for two weeks. He was given Motrin and was referred to the senior nurse, who saw him on March 13. The nurse noted his complaint of severe pounding headache and stuffy nose and ears "like on an airplane". He was given Dimetapp and Ibuprofen. A.J. appeared at sick call again on March 16 complaining of headaches that affected his vision. He was referred by the nurse to Dr. DeCespedes, who examined him and noted no acute distress, supple neck and 20/20 vision. Dr. DeCespedes gave him Ibuprofen and suggested return in ten days for follow up. On March 18, A.J. completed an inmate request form to medical: Doc I have been having headakes real bad ones, every day for three weeks now. On 3/17/90 I started to have trouble seeing. I can not fockus with both eyes open but can with one open at atime. Can you pleas help me quickely. thank you (Pet. Ex. #1, p. 15) The form is stamped received on March 19, 1990, "Medical, Charlotte Correctional Institution". That same date A.J. sent an "emergency grievance" to the assistant superintendent stating that the pain was very bad, that he was walking into things and stating that he needed medical assistance as soon as possible. Dr. Chapman examined A.J. on March 20; fundoscopy, temperature and neck movements were normal. Dimetapp was given, and a staff optometry appointment was scheduled for April 2. The staff optometrist examined A.J. and found no problems with his retina or vision but ordered glasses to help with the focusing. The optometry note in A.J.'s medical record states that the patient needs to be reevaluated by the M.D. because of the headaches. A.J. saw the nurse in the clinic on April 8 with complaints of continued, unchanged headache. He was given Ibuprofen and an appointment to see the doctor on April 10. Dr. DeCespedes' notes of examination on April 10 reflect normal findings and an order of an X-ray for sinuses. The X-rays, taken on April 12, reflected sinusitis. Dr. Chapman reviewed the file on April 10 and April 13; she found the work-up for headaches adequate and ordered Keflex for the sinusitis. Dr. Chapman examined A.J. at the clinic on April 17, when he reported feeling bad and unable to go to work. He refused a "lay-in" because he did not want to lose gain time and said, "my boss understands." The examination revealed normal findings. Dr. Chapman added Dimetapp to the Keflex already being taken and advised A.J. to keep his follow-up appointment with Dr. DeCespedes. A.J. appeared at the clinic several time on April 24. In the morning he reported, "I think I'm dying", stated his headache was much worse, held one eyelid half-shut and complained of blurred vision, tinnitis and photophobia. He said his sinuses no longer caused pain. The nurse gave him Ibuprofen and told him he had a doctor's appointment on the next day. The nurse noted he had lost 22 pounds since the end of November and 31 pounds since August. That same day, later in the afternoon A.J. reported to the clinic again, stating that he had gotten up to get a drink of water, blacked out and came to with someone holding him up. He said the Motrin provided no relief from his severe headache. His throat was slightly inflamed with some swelling on the right side. He was referred to the staff physician who observed the patient in distress and hyperventilating. He was given Darvocet; Dr. DeCespedes was consulted; and another sinus X-ray was ordered. On April 26, Dr. DeCespedes admitted A.J. to the infirmary after he had reportedly passed out in his bunk. The sinus X-rays reflected the sinusitis was resolved. From April 26 through April 30, A.J. continued to complain of headaches and loss of vision. A CT scan and bloodwork were ordered. Nursing notes from the infirmary reflect that A.J. was "looking" at TV with no apparent blindness. He was examined on April 30, by Dr. DeCespedes and by the optometrist, who found abnormal fundi (swelling of the optic nerve). The optometrist recommended an opthomologist (MD) consultation as soon as possible. Dr. Chapman examined A.J. at 6 p.m. on May 1. By then he was lethargic, unable to get up without assistance and had difficulty swallowing. Dr. Chapman noted the swelling of the optic nerve and ordered A.J. transferred to the local hospital. Laboratory work on admission showed elevated white blood count which had not been revealed in laboratory findings earlier. Other tests, CT scan and MRI, were initially normal, but brain edema appeared after the third day. Similarly, spinal taps indicated elevated spinal fluid which was clear at first, but, after the fourth hospital day tested positive for streptococcus. The diagnosis after several days was cryptococcal meningoencephalitis. A.J. lapsed into a coma and died at the hospital on May 8, 1990. Patient J. D. J. D., aged fifty-one, entered the Florida Department of Corrections system at the South Florida Reception Center on January 30, 1990. He had a history of peripheral vascular disease (PVD), diabetes and hypertension, and had undergone vascular surgery. In February 1990, under the auspices of the Department of Corrections, J.D. underwent further surgery to repair a prior graft. The patient had a bypass graft performed from the left groin to the right groin using an interposition graft at the left common femoral position, and a 6mm cross-over graft placed from the interposition graft to the right superficial femoral artery. J. D. was transferred to CCI around May 2, 1990. On arrival, he was evaluated by staff physician, Dr. DeCespedes, who noted his history, including the recent surgery. He was given a pass for no prolonged standing, was placed on a low cholesterol diet and was given a lower bunk assignment. Thereafter, J.D. was reevaluated by the staff physician on May 16, 1990; July 10, 1990; October 23, 1990; and February 21, 1991. February 21, 1991, is the first day that a complaint of pain by the inmate was noted. On February 21, 1991, Dr. DeCespedes' clinic notes reflect complaint of pain in J. D.'s legs and a mass in the left inguinal area. Dr. DeCespedes gave J.D. a light duty pass for a few days. On March 5, 1991, J.D. sent this inmate request to Dr. Chapman: Dr.Chapman. I am in the need of help. I have hardening and blood clots in the arteries. I had surgery at So. Fla. Reception in Feb. of last yr. at Larkin Hospital. For the past month I have been experiencing severe pain in my legs. More in the right leg and foot than the left. I saw Dr. DeCespedes last week and told her of the pain and numbness. I also told her that I was having trouble walking to the mess hall and back. She said "you have to walk" and didn't even look at my legs! Dr. I'm really afraid if I don't get some attention soon I may lose my leg. Inmate Logan Ward told me that you are familiar with this type of illness. Would you please call me to see you as soon as possible. I am really scared. My right foot is red and cold and numb most of the time. I have a lot of pain. Thank you. (Pet. #3, p. 169) An inmate request of similar urgency was sent by J.D. to the assistant superintendent the same day. Dr. Chapman responded by setting an appointment for J.D. to see her on March 29. On March 8, J.D. came to clinic reporting a medical emergency. The nurse noted left toes were purplish and cool; the right ankle and foot were cold and dark red and "unable to appreciate peripheral pulses". J.D. complained of pain behind his left knee and severe pain on slight touch to the right leg. He was referred to Dr. DeCespedes, who admitted him to the infirmary for observation. On examination, Dr. DeCespedes noted pulses and no edema. Dr. Chapman examined J.D. in the infirmary on March 13. She could not detect pulses in his lower extremities. She continued current medications and added Trental, a medication to increase blood flow. She ordered a Doppler pulse check and noted that the inmate should sign a medical release for records so that his prior hospital records could be obtained. Dr. Chapman also noted that the inmate should sign a consent sheet for peripheral vascular testing. On March 14, J.D. requested discharge from the infirmary, stating he felt better. He had complained early that morning that he could not sleep in the infirmary. Pulses were present but his lower extremities were cold. Dr. Chapman examined J.D. on March 29 and noted his severe peripheral vascular disease with leg pain. J.D. complained that he had been unable to get to the dining hall and guards were bringing him bagged lunches at times or a wheelchair. Dr. Chapman ordered a quad cane and crutches until the quad cane could be provided. She noted that he should have extra time to get to meals, but should not be given a wheelchair or bagged meals. She noted that she completed a consultation request for peripheral vascular testing by a vascular surgery consultant. For some reason unknown by Dr. Chapman and undisclosed by the record of this proceeding, J.D. was sent to a cardiologist, not a vascular surgeon. He was seen by Robert B. Garrett, M.D. on April 3. That same date, Dr. DeCespedes noted in J.D.'s clinical record that the cardiologist reported severe ischemia in the patient's legs, that J.D. needed special tests and he should be in a wheelchair, but twice daily he should walk 50 to 100 feet to exercise his legs. On April 10, J.D. sent an inmate request to the superintendent complaining about his medical treatment, stating he had pain and trouble walking, that he was given a wheelchair but that it was taken away, even though the specialist had recommended it. Dr. Chapman's response states that J.D. had a quad cane and was to be encouraged to be active. Further, the response states that J.D. had an appointment with her after his next specialist appointment. On April 11, 1991, Dr. Chapman reviewed Dr. Garrett's report and immediately requested a vascular surgery consultation. At some point, J.D. was transferred to administrative confinement, as requested by Dr. Chapman, so that he could have his meals delivered. J.D.'s vascular surgery consultation was scheduled for April 22, but was cancelled by security personnel and was rescheduled for May 9. CCI staff physician, Evidio Tornin, examined J.D. on April 30. He noted "no acute distress", but found a ischemic ulcer, nickel-sized, on J.D.'s right lower leg. He found severe circulatory insufficiency and was unable to detect pulses in J.D.'s extremities. The physician's notes acknowledge that J.D. had a vascular specialist appointment scheduled. Dr. Sweeney, the vascular surgeon, saw J.D. on May 9, 1991. His notes of the examination reveal he found a large ulceration on the right leg and a smaller ulceration on the left Achilles' tendon. Dr. Sweeney's impression was that the bypass grafts had occluded. Dr. Chapman's notes dated May 13 acknowledge the consultation with Dr. Sweeney, including Dr. Sweeney's concern that both legs would likely be lost if surgery were not done within the next two weeks. Dr. Chapman also noted that same date she had informed the regional utilization review nurse of the seriousness of the situation and the nurse agreed to an emergency admission to Southwest Florida Regional Medical Center under Dr. Sweeney's care. An arteriogram was scheduled for May 21, 1991, but was postponed for a day because of hospital equipment problems. After the test was done, Dr. Sweeney concluded that J.D.'s prior grafts were completely blocked and collateral vessels were supplying the only blood to his legs. Dr. Sweeney performed surgery to remove the infected grafts on May 28, 1991. After surgery, J.D.'s status deteriorated; his legs became non-viable and his temperature elevated to 103. On June 7, 1991, J.D. was taken to the operating room where Dr. Sweeney performed bilateral above the knee amputations. The Standard of Care CCI was a new prison when Dr. Chapman was hired to become its chief health officer. Originally built to house 700 inmates, it double-bunked to a maximum capacity of 1488 inmates by August 1989, and approximately 1400 inmates were housed there while Dr. Chapman was chief health officer. CCI was a close custody, medical grade IV institution. That is, it contained the most violent criminals with a full range of medical problems. Medical grade IV includes the sickest population in the correctional system, as well as all of the less serious medical grades. Dr. Chapman provided overall supervision to approximately 45 employees and direct supervision to approximately 10 employees. She held weekly and monthly staff meetings and was expected to review five sick call charts each day, Monday through Friday. There is ample evidence that Dr. Chapman periodically reviewed the files of both inmates at issue here. She was directly involved in their treatment and examined them personally on occasion. She was also responsible for their care as the supervisor of Dr. DeCespedes and the other staff physicians. Dr. Chapman's job was difficult, if not impossible, as conceded by the agency's expert witness. However, she violated the appropriate standard of care as to inmates A.J. and J. D. by failing to adequately supervise the treating physicians and by failing to obtain appropriate and timely consultations. The ultimate tragic outcomes of the two inmates' cases are plainly not the basis for this conclusion. Cryptococcal meningitis is a difficult disease to diagnose. And, there is a possibility J.D. would ultimately have lost his legs as a result of his persistent smoking, according to the warning of the cardiologist. Yet, in both cases there were increasingly urgent complaints by the subject inmates. Those complaints were deferred by punctilious observance of hollow routine, at best , and misplaced scepticism, at worst. In A.J.'s case, the treatment for sinusitis was appropriate, but the continued complaints of headaches and progressive loss of vision should have alerted the staff to a more pernicious cause. In J.D.'s case, although Dr. Chapman contends that his prior medical records were not obtained until several months after the amputations, the medical staff was well aware of his recent surgery and his history at the time he was received at CCI. The clues, in subjective complaints and in such objective physical signs as weak or non- existent pulse and ischemic ulcers, should have prompted a more immediate evaluation of his peripheral vascular status. In making the above findings of violations, substantial weight has been accorded the opinion of the agency witness, C. A. Rosenberg, M.D., who was appointed by the Federal District Court in 1983 after his nomination by the Department of Corrections, to serve on a three-physician survey team to monitor settlement of a case involving medical care in the Florida correctional system. Dr. Rosenberg's testimony was clear, competent and credible. He was not biased against the system, and was experienced in the role of a supervising physician. His analysis of the records he reviewed was incisive; that is, he distinguished convincingly between medical care that was appropriate and what was not. He acknowledged the difficulty of providing medical care under the circumstances experienced by Dr. Chapman and he confined his criticism to discrete, specific areas where action could have been taken, but was not. In that sense, although he articulated a standard of care that is the same standard imposed on a physician outside of an institutional setting, it is plain that he considered the conditions and circumstances under which Dr. Chapman labored in framing his opinion. Just as it is appropriate to consider these conditions and circumstances in determining whether a violation occurred, it is also appropriate to consider them in recommending an appropriate penalty. From her own testimony and those who have worked with her, Dr. Chapman is a caring physician and is well-respected. No evidence of other past discipline or cause for discipline appears in the record of Dr. Chapman's public service presented in this proceeding.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED: That the Board of Medicine enter its final order finding that Respondent violated section 458.331(1)(t), F.S. and establishing a penalty of two years probation and $2000 fine. DONE AND RECOMMENDED this 3rd day of March, 1995, in Tallahassee, Leon County, Florida. MARY CLARK 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 3rd day of March, 1995. APPENDIX The following constitute specific rulings on the findings of fact proposed by the parties as required by section 120.59(2), F.S. Petitioner's Proposed Findings Adopted or adopted in substance: Paragraphs #1-5, 7-8, 10-19, 21-25, 29- 35, 38-39, 42-52, 54-59, 61-67, 69-76, 81-84. Rejected as unnecessary: Paragraphs #9, 20, 26-28, 36-37, 40-41, 53, 78- 80. Rejected as unsupported by the weight of evidence: Paragraphs #60, 68, 77. Rejected as a conclusion of law, rather than finding of fact. (Moreover, the standard applied here is described in section 458.331(1)(t), F.S.): Paragraph #6 Respondent's Proposed Findings Adopted or adopted in substance: Paragraphs #1-3, 10-15, 17-21, 23-36 (with exception of final sentence), 37-48, 50. Rejected as unnecessary: Paragraphs #4-9, 16, 49. Rejected as unsupported by the weight of evidence: Paragraphs #22 (as to nursing notes being inconsistent with the blindness complaint), 27, 36 (final sentence-At least some evidence indicates he could not sleep in the infirmary and that is why he wanted to leave), 51-53. COPIES FURNISHED: Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Tom Wallace, Assistance Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Brett Thomas, Esquire Agency for Health Care Administration Legal Section 1940 North Monroe Street Tallahassee, Florida 32399-0792 Anthony D. Demma, Esquire Meyer and Brooks, P.A. Post Office Box 1547 Tallahassee, Florida 32302
Conclusions THE PARTIES resolved all disputed issues and executed a Settlement Agreement. The parties are directed to comply with the terms of the attached settlement agreement. Based on the foregoing, this file is CLOSED. DONE and ORDERED on this the L x. of , 2014, in Tallahassee, Florida. Be At yf. yor’ ABETH DUIEK, SECRETARY Agency for Health Care Administration 1 AHCA vs. Roberto Uriel, M.D., South Florida Pediatrics, C.}. 13-0344-000 Final Order Filed May 8, 2014 1:44 PM Division of Administrative Hearings A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO A JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Beverly H. Smith Assistant General Counsel Agency for Health Care Administration Office of the General Counsel (Interoffice Mail) Christopher A. Parrella, J.D., CHC, CPC, CPCO The Health Law Offices of Anthony C. Vitale, P.A. Law Center of Brickell Bay 2333 Brickell Avenue, Suite A-1 Miami, FL 33129 (U.S. Mail) Richard Zenuch, Chief, Medicaid Program Integrity Finance and Accounting Health Quality Assurance Florida Department of Health 2 AHCA vs. Roberto Uriel, M.D., South Florida Pediatrics, C.I. 13-0344-000 Final Order CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to the above named addressees by U.S. Mail or other designated method on this the Bas of 45 , 2014, Richard Shoop, Esquire Agency Clerk State of Florida Agency for Health Care Administration 2727 Mahan Drive, MS #3 Tallahassee, Florida 32308-5403 (850) 412-3630/FAX (850) 921-0158 3 AHCA vs. Roberto Uriel, M.D., South Florida Pediatrics, C.1. 13-0344-000 Final Order
Findings Of Fact Petitioner, Department of Health and Rehabilitative Services (DHRS), is the agency responsible for insuring the integrity of the Medicaid program in the State of Florida. Medicaid is a joint program, funded by the federal government and, in Florida, by the State of Florida. Consequently, Medicaid providers are subject to federal and state regulation. Respondent, Southpointe Pharmacy (Southpointe), is a pharmacy located in Dade County, Florida, that participates in the Medicaid program by providing medication to Medicaid recipients and receiving reimbursement for that medication from DHRS. Southpointe is owned by Marco Burgos. The DHRS Office of Program Integrity has the responsibility for insuring that the goods and services billed to the Medicaid program are those that are actually provided to Medicaid recipients. At the times pertinent to this proceeding, DHRS contracted with Professional Foundation for Health Care (PFHC) to conduct audits of pharmacies. The audit period pertinent to this proceeding was from November 1, 1987 through July 31, 1988. In early 1989, PFHC conducted a routine audit of Southpointe. This routine audit is a general audit of a number of factors related to the provision of medications by a pharmacy and includes an examination of prescriptions in the pharmacy, an analysis of prices that are charged, and a review of the inventory of certain drugs to determine whether the volume of drugs on the shelf is consistent with the quantity of drugs that have been previously billed to Medicaid. Three computer printouts were generated for use of PFHC in the routine audit of Southpointe. The first computer printout was a random sampling listing two hundred Medicaid claims out of the several hundred Medicaid claims that had been submitted by Southpointe during the audit period. The second computer printout and the third computer printout listed all of the drugs that had been paid for by the Medicaid program to Southpointe during the audit period. The second printout listed these drugs according to the total dollar amount of the claims paid for each respective drug while the third listed the drugs alphabetically. After the routine audit was concluded, the results were sent to the Medicaid Program Integrity Office where it was reasonably determined that further action would be warranted. The routine analysis had been for screening purposes only, and did not serve as the basis for the position asserted by DHRS in this proceeding. DHRS decided to conduct a further audit, referred to as an aggregate analysis. DHRS based its conclusion that Southpointe had been overpaid based on the results of the aggregate analysis. Prior to the date of the formal hearing in this case, DHRS had not promulgated a rule specifically authorizing the aggregate analysis auditing method, but instead utilized incipient, non-rule policy, and then sought to explicate that policy at the hearing. An aggregate analysis is a more detailed audit that is typically done on behalf of DHRS by a contractor such as PFHC. The aggregate analysis does not review the medicaid payments to a provider on a claims by claims basis. Instead, it is a statistical analysis in which claims that have been billed to and paid by the Medicaid program are reviewed to determine whether the pharmacy purchased a sufficient quantity of each respective drug to cover the provider's billings to the Medicaid program for that drug. The aggregate analysis is designed to determine whether the pharmacy's inventory levels are consistent with its Medicaid billings. If the billings to Medicaid exceed the amount of the drug that the provider had available for distribution during the period being audited, DHRS presumes that the pharmacy's Medicaid claims are not justified to the extent of the excess and that the pharmacy has been overpaid. The aggregate analysis examines the top 100 drugs dispensed by Southpointe during the audit period based on the dollar value of all claims for those drugs. The auditors then attempt to determine the extent of the overpayment for each individual drug by determining whether the quantity of the drug billed to Medicaid exceeds the quantity of the drug available for sale by the pharmacy. If the quantity of the drug billed to Medicaid exceeds the quantity of the drug available for sale by the pharmacy, the differences in quantity is multiplied by the price of the drug which produces the dollar amount of the overpayment. The overpayment for all drugs are then added to derive the total of the alleged overpayment. In conducting the aggregate analysis, DHRS' auditors presumed that all drugs available to Southpointe were dispensed to Medicaid patients. It had been calculated that 71 percent of Southpointe's business was comprised of Medicaid recipients. The initial calculations (which included the Gulf Distributors information that was not shown to be reliable) were based on the presumption that only 71 percent of the drugs available to Southpointe would have gone to Medicaid recipients and produced an initial determination that the overpayment was $60,201.02. A revised calculation (which also included the Gulf Distributors information) presuming that all of the drugs available to Southpointe would have gone to Medicaid recipients produced a determination that Southpointe had been overpaid in the amount of $50,247.25. The main supplier for Southpointe is Gulf Distributors. Southpointe was asked to provide all invoices for drugs it had purchased from any supplier other than Gulf Distributors during the pertinent period, but it was not asked to provide any invoices or any other evidence of purchases of drugs it had made from Gulf Distributors. Instead, DHRS relied on information in the form of a computer printout it had received directly from Gulf Distributors. DHRS failed to establish that the data reflected by the computer printout was reliable or that the subsequent portions of the aggregate analysis, which depended on the unreliable computer printout, accurately reflected an overpayment to Southpointe. Southpointe purchases drugs manufactured by Upjohn Company (Upjohn) and by Merck, Sharp and Dohme Company (MSD) directly from those manufacturers without going through Gulf Distributors. Southpointe, at the telephonic request of JoAnn Padell, produced the invoices from Upjohn and MSD for analysis by Joseph Kopotowsky. Both Ms. Padell and Mr. Kopotowsky are pharmacists employed by PFHC as auditors. Mr. Kopotowsky, the only representative of PFHC who made personal contact with Southpointe, did not testify at the formal hearing. Southpointe was given adequate time to produce those invoices, and there was no claim that the invoices produced were incomplete or inaccurate. However, there was no evidence that Southpointe was told what the auditors intended to do with the invoices or how the audit was being conducted. The aggregate analysis of twelve drugs purchased by Southpointe from Upjohn Company and from Merck, Sharp and Dohme Company reflected an overpayment to Southpointe in the total amount of $7,301.68. The analysis assumed that the invoices Southpointe gave Mr. Kopotowsky constituted all of the drugs manufactured by Upjohn and MSD that were available to Southpointe for distribution during the audit period. There was no evidence that the auditors asked whether Southpointe acquired additional drugs manufactured by Upjohn and MSD by means other than purchase from these manufacturers. It is common practice for pharmacies to exchange or barter inventory, and such exchanges would not be reflected by an examination of the invoices of purchases directly from the manufacturers. There was no evidence that the auditors asked to see records of such acquisitions. There was no evidence as to the shelf life of any of these drugs or that DHRS, through its auditors, accurately determined Southpointe's beginning or ending inventory for the Upjohn and MSD drugs. Without this information, the aggregate analysis, upon which DHRS bases its claim for overpayment, is flawed and does not accurately reflect an overpayment to Southpointe. DHRS relied exclusively on the auditing procedures described herein. DHRS did not check with any Medicaid recipients to see whether they had actually received their medications, nor did DHRS check with any of the physicians to see if the prescriptions had actually been prescribed, even though it had access to the identities of the patients and the physicians. DHRS has withheld amounts from the Medicaid payments due Southpointe. The amounts withheld was not established at the formal hearing.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered which dismisses this action against Southpointe Pharmacy; which orders that any amounts withheld from Southpointe Pharmacy's Medicaid payments be promptly paid to Southpointe Pharmacy, together with interest at the rate of 10 percent per annum pursuant to Sections 409.266(14), and 409.335(3), Florida Statutes; and which removes any other sanctions imposed against Southpointe Pharmacy as a result of the subject audit. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 15th day of November, 1990. CLAUDE B. ARRINGTON 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 15th day of November, 1990. APPENDIX TO THE RECOMMENDED ORDER The following rulings are made on the proposed findings of fact submitted on behalf of the Petitioner, Department of Health and Rehabilitative Services. The proposed findings of fact in paragraphs 1-12, 21-25, 29, 32-39, 47, 60, and 68 are adopted in material part by the Recommended Order. The proposed findings of fact in paragraph 13 and 72-77 are rejected as being argument which is discussed in the conclusions of law section of the Recommended Order. The proposed findings of fact in paragraph 14, 27, and 63 are rejected as being unnecessary to the conclusions reached and are discussed in the preliminary matters section of the Recommended Order. The proposed findings of fact in paragraph 27 are also discussed in the conclusions of law section of the Recommended Order. The proposed findings of fact in paragraphs 15, 18-20, 26, 48-49, 57- 59, 62, 64-67, 69, and 71 are rejected as being unnecessary to the conclusions reached. The proposed findings of fact in paragraphs 16-17, 28, 30-31, 40-43, 45-46, 50-56, and 70 are rejected as being subordinate to the findings made. The proposed findings of fact in paragraph 44 are rejected as being unsubstantiated by the evidence since there was no evidence that Mr. Burgos was asked that question or that he was under an affirmative duty to make such a statement. The proposed findings of fact in paragraph 61 are rejected as being unsubstantiated by the evidence since the testimony upon which the proposed finding is based related to all of Southpointe's questioned billings, not just the twelve from Upjohn and MSD. The following rulings are made on the proposed findings of fact submitted on behalf of the Respondent, Southpointe Pharmacy. The proposed findings of fact in paragraphs 1-7 and 9-10 are adopted in material part by the Recommended Order. The proposed findings of fact in paragraph 8 are rejected, in part, as being unnecessary to the conclusions reached and are discussed to the extent deemed pertinent in the conclusions of law section of the Recommended Order. COPIES FURNISHED: William M. Furlow, Esquire Katz, Kutter, Haigler, Alderman Eaton, Davis & Marks, P.A. Post Office Box 1877 Tallahassee, Florida 32302-1877 David G. Pius, Esquire Senior Attorney Building 6, Room 233 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Linda K. Harris, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: Petitioner, South Medical, is a Florida Medicaid provider, having been issued provider number 0626937-00. At all times material hereto, South Medical was owned by Alicia Vidal- Zas and her husband Juan Zas. They started the company in early 1990. Neither Alicia Vidal-Zas nor Juan Zas are medical doctors. There is no evidence that South Medical has ever had any physician employees or that any physicians have ever owned a part of the company. South Medical is a radiology and diagnostic center which performs x- rays, sonograms, and diagnostic studies including cardiovascular studies and spirometry. South Medical contends that it only performed tests or procedures after a referral from a physician. Other than a couple of instances of minor errors in coding, no evidence was presented that South Medical ever billed Medicaid for any tests which had not been ordered by a physician. Respondent's April 22, 1992 letter terminating South Medical from the Medicaid Program (the "Termination Letter") cites three grounds: "(1) Documentation in the medical records does not reflect medical necessity for the x-rays and other diagnostic tests billed to Medicaid; (2) the physician listed as treating provider did not render the services; (3) the provider actually reading and interpreting the results of the tests was not a member of the group." At the time this Termination Letter was written, Respondent presumed that South Medical was a group of physicians providing services since that was the way South Medical was enrolled in the Medicaid Program. As discussed below, this enrollment was in error since South Medical did not employ any physicians. A large percentage of the tests performed by South Medical were ordered by Dr. Leon Hirzel. Dr. Hirzel's relationship with South Medical is discussed in more detail below. Respondent's expert, Dr. John Sullenberger, reviewed a random sample of South Medical's files. All of those files contained referrals from Dr. Hirzel. Dr. Sullenberger concluded that the medical necessity for the tests that were performed and billed to Medicaid was often not reflected in the records he reviewed. While the records he reviewed included the referral forms from Dr. Hirzel's office and some records reflecting the patients' histories and diagnoses, it is not clear whether Dr. Sullenberger had access to all of the pertinent records of the physician who ordered the tests. It should also be noted that Dr. Sullenberger did not talk to Dr. Hirzel or to any of the patients. In the April 22, 1992 Termination Letter, Respondent alleged that South Medical was overpaid $264,122.38 by the Medicaid Program for tests conducted by South Medical which were purportedly not medically necessary. The Termination Letter suggests that the amount of the alleged overpayment was determined by extrapolating the results of the random survey of South Medical's files to all of the claims submitted by that company. In other words, Respondent apparently concluded for purposes of the Termination Letter, that all of the Medicaid payments made to South Medical should be refunded. No competent evidence was offered at the hearing to establish the amount of the claims submitted by South Medical and no explanation was given as to the manner in which the $264,122.38 alleged overpayment was calculated. At the hearing in this matter, Respondent stated that it had reduced its claim for overpayment to $161,802.80. Other than the conclusory deposition testimony of Ellen Williams, no evidence was presented to explain how this amount was calculated. In Respondent's unilateral prehearing stipulation, there is a representation that there was "no challenge to the validity of the statistical methods used in this case." No such conclusion is included in Petitioner's pleadings. In fact, Petitioner offered some evidence challenging the contention that the tests performed were not medically necessary. Since this evidence was vague and not tied to specific files, it is not possible to reach any conclusions as to the medical necessity of the tests in any particular case. The testimony of Respondent's expert raises considerable doubt as to the medical necessity for many of the tests performed in the files reviewed by Respondent's investigators. However, none of the files were offered into evidence and no competent substantial evidence was offered as to the tests conducted in any particular case. Furthermore, it is not clear that Respondent had all of the documents necessary to make a determination of medical necessity with respect to the files it reviewed. Respondent's investigators reviewed approximately twenty-seven files obtained from South Medical. Respondent also requested South Medical to produce the medical charts from Dr. Hirzel. The evidence was insufficient to establish that Respondent obtained all of the records from the referring physician, Dr. Hirzel. Moreover, none of the investigators talked to the referring physician or any of the patients. It should also be noted that, since South Medical was merely a diagnostic laboratory, it did not have the authority to question the medical necessity for the tests ordered by the referring physician. Finally, while Section 409.913(12), Florida Statutes, permits Respondent to use statistical methods in determining an overpayment, no evidence was offered in this case to establish a reasonable statistical method. No stipulation or evidence was offered to establish the statistical methodology used by Respondent or the number or amount of claims to which the methodology was applied. For these reasons, Respondent has not established in this proceeding its right to a refund for tests performed by South Medical that were allegedly not medically necessary. Respondent suggests that there was a suspicious consistency in the diagnoses and tests ordered for a number of the South Medical patients whose files were reviewed. While Dr. Sullenberger's testimony certainly raises some concerns in this regard, insufficient evidence was presented regarding these alleged consistencies to draw any conclusions. At the time the April 22, 1992 Termination Letter was drafted, Respondent was under the impression that South Medical was a group of physician providers. The evidence clearly established that South Medical was not a physician group. Nonetheless, as discussed in more detail below, that is the manner in which South Medical was listed in the computer records of the Medicaid Program. South Medical contends that its mistaken enrollment was the result of bureaucratic bungling. Unfortunately, the evidence presented at the hearing regarding the enrollment of South Medical in the Medicaid Program was often confusing and inconclusive. It is necessary to review the facts as best can be determined from the evidence presented. To become a participant in the Medicaid Program, a provider has to fill out a Provider Enrollment Application (the "Application Form.") Shortly after South Medical was formed, it submitted an Application Form seeking enrollment as a provider in the Medicaid Program. The Application Form requires the applicant to provide certain information regarding the "provider type," the specialty involved, the type of practice, the ownership of the provider, and the "category of service." The applicant is provided with a numerical code key and is expected to fill in the blanks on the Application Form with the appropriate numerical code that corresponds to the business. The code key for the Provider Type includes a detailed listing of numerous kinds of providers of health care services including several types of hospitals and clinics, a number of different categories of individual health care providers ranging from social workers to medical doctors, several different types of transportation services and a number of testing facilities including dental laboratories, independent laboratories, portable x-ray companies, and dialysis centers. Alicia Vidal-Zas, who filled out the Application Form for South Medical, contends that she was uncertain as to the appropriate classification for her company and, therefore, left this blank empty on the Application Form she submitted. Consultec is a fiscal intermediary that processes claims and provider applications for the Medicaid Program. The Application Form on file with Consultec for South Medical has the provider code "99" (which corresponds to an electronic media claims intermediary) written in the box for the Provider Type. The evidence was inconclusive as to the person who entered that code in the provider blank. The "99" is crossed out and "25" is written next to it. That code corresponds to a physician provider. There is also a parenthetical notation on the Application Form which states "does vascular studies." As best can be determined from the evidence presented in this case, the "25" and the notation regarding vascular studies were made by a Consultec representative. Respondent suggests that Consultec contacted South Medical for clarification as to the types of services being provided and the Consultec representative was told that South Medical did vascular studies. Respondent further suggests that, since vascular studies can allegedly be performed only by a physician, the Consultec representative concluded that South Medical was a physician provider group and should be enrolled that way. Unfortunately, no conclusive evidence was presented on these issues. No representative from Consultec testified and only Petitioner's version of its enrollment has been presented. Petitioner denies that it ever advised Consultec that it was a physician group and claims that it never sought enrollment as anything other than a diagnostic laboratory. The Application Form on file with Consultec for South Medical reflects a specialty code of "99" for the specialty of the provider. This code indicates that the applicant's specialty is something other than the sixty-three listed physician specialties, (including several categories of radiology) or eighteen other categories of specialties set forth in the code key. The evidence did not establish who completed this part of the Application Form. The Type of Practice blank on the Application Form is filled in with a "99" which reflects a practice other than the types specified in the code key. The code key includes separate categories for an individual practice as well as for a group practice. The evidence established that Alicia Vidal-Zas completed this section of the Application Form. There is one page of the Application Form which calls for certain, additional information for "group membership." It does not appear the South Medical provided any information on this page. Nonetheless, there is an indication on that page that Consultec approved enrollment as a physician group. The code key for the Category of Service blank on the Application Form sets forth over thirty different types of services. The Application Form on file with Consultec for South Medical originally had the number "65" (which reflects a home health service) written in. The "65" was entered by Alicia Vidal-Zas at the time she submitted the Application Form. No adequate explanation was offered as to why South Medical was described as a home health service when that was clearly not the business in which it was engaged. On the Application Form on file with Consultec, the number "65" was crossed out and next to it was written the number "25," which represents "physician care (MD)." It is not clear when this change was made or who made it. It was apparently done by someone at Consultec. No conclusive evidence was presented as to the basis for this change. While the evidence was sketchy regarding the communications that took place between Consultec and South Medical, it is clear that some discussions took place after the Application Form was submitted. On September 11, 1990, Alicia Vidal-Zas sent a letter to Teresa Jones of Consultec which provided as follows. As per our telephone conversation of this morning, I providing [sic] the information needed. Leon F. Hirzel, Jr., (Medicaid No. 069389800) is affiliated with South Medical Services, Inc. Shortly after the September 11 letter, South Medical was accepted as a provider in the Medicaid Program as reflected in a letter dated September 29, 1990. However, no direct evidence was presented that the September 11 letter was considered in enrolling South Medical in the Medicaid Program. The computer printout from Consultec for South Medical reflects Dr. Hirzel as a member of South Medical. Likewise, Dr. Hirzel's printout from Consultec reflects that he is a member of South Medical. Other than noted above, no evidence was presented as to the basis for these computer printouts. Without question, the enrollment information provided by South Medical was vague and contained significant omissions. The September 11, 1990 letter is particularly troublesome. South Medical contends that, after it began submitting claim forms for payment to Medicaid, it encountered difficulties in receiving payment. South Medical says that it contacted Consultec and was told that the Medicaid Program could not pay the claims submitted because the referring physician was not listed on the claims form and it was not clear the referring physician was a provider under the Medicaid Program. Consultec purportedly told South Medical that the claims could not be processed without the referring physician's provider number. South Medical claims it gave Consultec Dr. Hirzel's physician provider number in the September 11 letter and, on subsequent claims forms, filled that number in a blank on a section of the claims form titled "Leave Blank." This justification for the September 11 letter fails to explain why Dr. Hirzel is referred to as being "affiliated" with South Medical. While this explanation is unsatisfactory, Respondent has not provided evidence as to the consideration, if any, given to the September 11 letter. While there is a great deal of confusion surrounding the application submitted by South Medical, the evidence clearly established that South Medical was enrolled in the Medicaid Program as a physician group. At the time of its enrollment, South Medical was provided with the handbook for submitting physician claims under the Medicaid Program. South Medical was also provided with a phone number to call if it had any problems or questions regarding the program. Petitioner claims that it simply followed the handbook directions as best it could and did not realize it had been provided with the wrong book. The excerpts of the handbook that were introduced into evidence are clearly identified as the Medicaid Physician Provider Handbook. However, the directions contained in the excerpts provided are generic in nature and would not necessarily be inappropriate for any provider. In submitting its claims, South Medical used physician billing codes. These codes represent a comprehensive service which includes the administration of the test and the professional interpretation of it. In other words, since no modifier or explanation was included, South Medical was billing a "global fee" for the entire service. Because South Medical had no physicians on staff, it was not entitled to bill Medicaid a global fee using the physician billing codes. No evidence was presented as to the appropriate billing codes and amounts for an independent laboratory. Thus, it is impossible to determine from the evidence presented in this case what the difference was between the amount billed by South Medical and the amount to which it would have been entitled if it was properly enrolled as an independent laboratory. In submitting claims forms to Medicaid, South Medical did not fill out any of the information regarding the patient's condition, disability, etc. The forms submitted simply included the date of service, the type of procedure, the diagnosis code and the charges for services rendered. The information was based upon the referral records received from Dr. Hirzel. It appears that the claims were paid as submitted. However, no conclusive evidence was offered on this point. Alicia Vidal-Zas admitted that, under a column headed "Leave Blank" on the claims forms, she filled in Dr. Hirzel's Medicaid provider number. She claims that this number was filled in at the direction of the Consultec personnel who told her that the referring physician's number should be placed there. This explanation is not consistent with the instructions in the claims handbook provided to Petitioner. However, while Petitioner's explanation is difficult to believe, it was not successfully refuted. The only conclusion that can be reached based on the evidence presented was that South Medical was confused as to the proper manner to bill for the tests it performed. South Medical's confusion does not excuse its obligation to determine the proper billing codes. However, the evidence was insufficient to conclude that South Medical's billing was fraudulent. As noted above, Dr. Hirzel was the referring physician on most of South Medical's patients. Dr. Hirzel was located in the same building as South Medical. The evidence indicates that, at least for the year beginning January 1, 1991, Dr. Hirzel rented his office space from South Medical for an annual rent of $3,600.00 per year. There was no other evidence of any relationship or connection between Dr. Hirzel and South Medical. Dr. Hirzel was originally enrolled as a provider in the Florida Medicaid Program beginning in 1984. South Medical suggests that Dr. Hirzel's enrollment expired and that he renewed his provider agreement in July of 1990. The alleged expiration of Dr. Hirzel's enrollment was offered as an explanation for the September 11, 1990 letter. However, the evidence on this issue was not conclusive and Dr. Hirzel's 1990 Medicaid application was not authenticated. South Medical sent at least one letter to a patient in November of 1991 advising the patient that she was due "for her next doctor's appointment." That letter specifically directed the patient to "please call the office to schedule a new appointment. Our telephone number is (305) 267-5008. We are looking forward to seeing you again." It is not clear who the patient's doctor was and/or what that doctor's involvement was with South Medical. While this correspondence suggests that South Medical's involvement may have been more than it claimed at the hearing, no further evidence was presented, thus no conclusions can be drawn. The confusion surrounding South Medical's enrollment in the Medicaid Program and its close relationship with the physician who was referring most of its patients is certainly cause for concern and investigation, however, the evidence presented in this case was insufficient to conclude that South Medical was the alter ego of Dr. Hirzel and/or that it was obligated to determine the medical necessity of all the tests he ordered. There is no evidence that South Medical ever performed tests that were not requested by a physician or ever billed for services which it did not perform. There was a suggestion during the hearing that a "Dr. Elias" read and interpreted the test results for South Medical. No explanation was provided as to his relationship with South Medical and/or the basis upon which he was providing professional services. There is no indication that he was enrolled as a provider in the Medicaid Program. In addition to challenging the medical necessity for many of the tests performed by South Medical, Respondent also complains that the records it reviewed were often insufficient to justify the diagnoses made. However, as noted above, it is not clear that Respondent ever obtained all of the treating physician's records. While the records of South Medical were often insufficient to justify the diagnoses reflected in the records and/or the tests that were ordered, it cannot be concluded that the physician's records were also inadequate. In this regard, it should be noted that South Medical performed tests for some physicians other than Dr. Hirzel.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Agency for Health Care Administration enter a Final Order terminating Petitioner, South Medical Services, Inc. from the Medicaid Program, and imposing an administrative fine of $7,000. No conclusion is reach herein as to whether Respondent can seek reimbursement of the alleged overpayment in this or a subsequent proceeding upon submission of appropriate evidence to establish the amount of the overpayment. DONE and ENTERED this 14th day of December 1993, at Tallahassee, Florida. J. STEPHEN MENTON 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 14th day of December 1993.
Findings Of Fact Petitioner South Broward Hospital District operates Memorial Hospital located in Hollywood, Florida. On March 14, 1977, Petitioner's hospital administrator, S. A. Mudano, informed the local Health Systems Agency (HSA), which is the Health Planning and Development Council for Broward County, Inc., of Petitioner's intent to acquire an 18 million electron volt linear accelerator capable of providing radiation therapy by means of both X-ray and high energy electrons for its radiation therapy department. The cost of this acquisition was to be $455,000.00 for the machine and accessories, plus approximately $150,000.00 for construction of an addition to the existing radiation therapy department to house the unit and support facilities. This notice of intent was followed by submission of an application to the HSA and Respondent on June 20, 1977. The application was reviewed by the staff of the HSA and, although it was determined that the project did not conform to certain criteria contained in the "Goals and Standards for Diagnostic Radiology, Therapeutic Radiology, and Nuclear Medicine Services" which had been adopted by the HSA after public hearings on August 18, 1977, the HSA recommended the project for approval on October 20, 1977, and so informed Respondent on October 28, 1977. By letter of November 23, 1977, Respondent informed Petitioner that its proposal was not favorably considered because it was inconsistent with the aforesaid local goals and standards for Broward County in that maximum utilization of existing and available like equipment items had not been achieved nor projected, and that such radiation therapy units were accessible within Broward County in less that sixty minutes automobile travel time. In this letter, Respondent pointed out that existing radiation therapy units in Broward County had been utilized at only some 61 percent of their capacity in 1976 and were projected as having only the utilization rate of 87 percent by 1990, and that such rates clearly indicated a lack of demonstrated need for an additional unit. The letter further stated that although the HSA had recommended approval, it had not provided justification for its deviation from its own goals and standards. Petitioner thereafter appealed Respondent's denial of its application on December 20, 1977. (Exhibits 1 - 5) Petitioner South Broward Hospital District is a special tax district created and incorporated by a legislative act of 1947. Memorial Hospital is its only facility and provides medical care on a non-profit basis to persons in the district requiring such treatment. However, individuals living outside of the tax district who require services of Memorial Hospital may utilize the same based upon medical need and criteria established by the district's Board of Commissioners. The radiation therapy department of Memorial Hospital was constructed several years ago and presently has in use a 4 MEV linear accelerator to serve the needs of South Broward cancer patients, mostly on an outpatient basis. In 1977, this machine was operated at 116 percent capacity computed on a forty-hour week and rendered 9,655 patient treatments during that period. The first quarter of 1978, 3,056 treatments were performed, which was a utilization rate of 147 percent on a forty-hour week and 98 percent on a 60-hour week. At the time the radiation therapy department was planned, it was anticipated that additional equipment would be required in the future and therefore "shell" space was reserved in the original construction plans for ease of future installation of new equipment. Construction for the proposed linear accelerator primarily will consist of construction of a concrete vault within the existing shell, plus facilities for operation of the radiation equipment. It will take approximately 18 months "lead-time" from issuance of a Certificate of Need to acquire the equipment, and complete construction. (Testimony of Mudano, Margulies, Exhibits 1, 16, 19) Radiation therapy in cancer cases is accomplished by both external therapy machines and sealed sources of radioactive material The machines include both conventional X-ray machines and the super voltage or megavoltage units which include linear accelerators, cobalt, and betatron units. The conventional machines are used primarily for superficial treatment, such as skin cancer. The megavoltage units deliver much heavier radiation to deep tumors with greater intensity so that a localized volume of tissue can be treated without the danger of damaging surrounding organs and normal tissue. They also produce less side effects such as nausea, weakness and anemia. However, the cobalt and betatron methods have certain limitations which make them less satisfactory for many patients than the linear accelerators. The linear accelerators most commonly used today are those of 4, 6, and 18 million electron volts (MEV). The 18 MEV accelerator provides deep therapy by utilizing an electron beam that is highly controllable to most effectively treat tumor tissue. Additionally, high-energy X-ray radiation can be delivered from an 18 MEV unit for deeper penetration. The 18 MEV is thus particularly effective for obese cancer patients and for those requiring treatment in the neck and head areas. Although machines of lesser voltage, such as the 4 MEV, are capable of treating all types of cancer patients, they do not protect adjoining organs and non-cancerous tissues to the degree afforded by the 18 MEV, nor can they be utilized for the variety of radiation patterns of the larger machine which has the additional flexibility of using pure electron radiation. (Testimony of Green, Margulies, Munson, Exhibits 1 - 2) At the time the HSA staff evaluated Petitioner's application, it predicated much of its data upon the utilization of existing radiation machines in Broward County at various hospitals and one private clinic. The staff report showed that there were four cobalt units, one betatron unit, and four 4 MEV units in Broward County. In addition, the report took into consideration one 18 MEV unit for which a Certificate of Need had been issued for the North Broward Hospital on March 12, 1977, and which is expected to be operational in January, 1979. At the hearing, however, it was discovered that both the HSA and the Respondent had overlooked the fact that a Certificate of Need for three MEV units had been issued to the Florida Medical Center in Broward County on June 27, 1975. It is expected that one 18 MEV unit and two 6 MEV units will be operational in that facility in July, 1978. In view of this information, the Hearing Officer determined that prior data was incomplete and required the parties to make new projections of need for presentation at a subsequent hearing session. The revised data is shown in composite Exhibit 16 and forms the basis for consideration of the need for Petitioner's requested additional 18 MEV unit. (Testimony of Chamlis, Composite Exhibits 16, 19, 21) Although the Respondent has a state medical facilities plan in existence, it does not address the question of radiation equipment. Consequently, the only general criteria issued by an agency in the state on this subject bearing on Petitioner's application is the document issued by the HSA entitled "Goals and Standards for Diagnostic Radiology, Therapeutic Radiology, and Nuclear Medicine Services." The pertinent provisions of that document which were used by the Respondent as a basis for denial of Petitioner's application read pertinently as follow: Cost -. High quality radiology and nuclear medicine services should be provided in the most efficient and effective manner, minimizing duplication of services and facilities, as well as expenses incurred. The utilization of each piece of equipment, and all services, should be maximized; services should be an effective and economical use of resources. If there are excess providers and excess capacity exists, growth or an increase in capacity should be discouraged. If an adequate number of providers exists, yet there is excess capacity, there should not be an increase in services until demand catches up. This does not exclude an allowance for new developments or techniques. If there is an adequate number of providers and sufficient capacity, providers should be encouraged to expand services only in response to an increase in demand. This does not refer to new modalities and services previously unavailable. If there are too few providers and inadequate capacity, existing providers should be encouraged to expand and/or additional qualified providers should be encouraged to offer services. Accessibility -. Quality radiology and nuclear medicine services should be reasonably accessible to all individuals in need, taking into consideration: transportation, sociological and cultural factors and relationships to all components of the health care system. B. Radiation therapy services and equipment should be accessible to the population within sixty (60) minutes travel time by automobile. D. Regardless of economic status, race and geographic location, all individuals should have access to radiology and nuclear medicine services at the most appropriate setting with the most efficient and effective use of resources. The HSA "goals and standards" are a part of its comprehensive health systems plan promulgated to comply with federal and state law and regulations, and are designed to achieve the optimum or ideal health care situation in the community. Although the governing body of the HSA determined that Petitioner's project would not meet the goals contained in paragraphs III C and IV 18, it recommended approval of the application because of "extenuating circumstances." (Testimony of Margulies, Anderson, Tupler, Marrinson, Composite Exhibit 7) Broward County has six hospitals and one private clinic where radiation therapy units are located. However, the two 18 MEV units which have been approved by Respondent will be located in the North Broward Hospital and Florida Medical Center, both of which are in the northern part of the country. Although from a mileage standpoint, each of these facilities is accessible to the county population within an hour's driving time, the large population in the area and congested highways would make it impossible for residents of the extreme southern part of the county to reach these facilities by bus or automobile in sixty minutes during normal hours. If elderly cancer patients living in South Broward County are required to expend the time necessary to journey to the facilities located in the northern part of the county for outpatient services, it would be deleterious to their mental and physical condition, and would be disruptive to the "team" concept employed at Memorial Hospital for the diagnosis, care, and cure of cancer patients. (Testimony of Margulies, Cohen, Tupler, Rodensky, Hartley, Atkin, Marrinson, Zenkel, Boyd, Nelson, Miller, Bennett, Spiegel, McPherson, Exhibits 10, 13 - 15, 17) The data compiled by the HSA and Respondent to assess the need for an additional 18 MEV linear accelerator was obtained from patient statistics in Broward County for prior years and projections of necessary equipment in the future predicated on on a variety of factors. These include population figures, incidence rate for cancer nationally and in Broward County, numbers of patients previously treated in local hospitals and numbers of treatments, estimated capabilities of existing and approved units based on a forty-hour, forty-eight hour and sixty-hour week basis, projected need in the future for radiation therapy treatments, and the percentage of past and projected therapy equipment utilization in Broward County. In its revised statistical charts, Respondent also applied similar projections solely with respect to the population and equipment located in South Broward County. Additionally, it included projections relative to the need and utilization of high-energy equipment, including the betatron machine at Broward General Hospital and the two 18 MEV's which will become operational in the future. Petitioner presented data based primarily on projected utilization of equipment in the South Broward area, and therein employed certain standards and criteria recently announced by the Department of Health, Education and Welfare as national guidelines which will govern health system plans developed after December 31, 1978, unless modified as authorized therein in certain instances. (42 CFR 121.209) The Hearing Officer took official recognition of these guidelines which provide that each megavoltage radiation therapy unit such as Cobalt 60 and linear accelerators, should serve a population of at least 150,000 persons and treat at least 300 cancer cases annually within three years after initiation, and that no additional units should be opened unless each existing unit in the health service area is performing at least 6,000 treatments per year. However, adjustments downward may be justified when travel time to an alternate unit is a serious hardship due to geographic remoteness based on analysis by the HSA. The guidelines indicate that about half of new cancer patients require megavoltage radiation therapy and that the 6,000 treatment standard reflects an average of about 25 patients or treatments per day as a reasonable standard. However, it is also stated that extra high energy machines which have "limited but important applications" may not reach such numbers of treatments and should be evaluated individually by HSA's in the development of the health systems plans. Also, it is noted that when each existing unit cannot reasonably be expected to reach the target level and a new unit is appropriate, the HSA may call for an adjustment in the standard based on pertinent local conditions. Such local conditions may include the age of the local population, seasonal population fluctuation, and access to needed care. (Exhibits 16, 19 - 20) In consideration of the foregoing facts and supporting exhibits, and in the absence of specific published state criteria, the following findings as to the actual projected need are made: Projected need should be based on the year 1980 because Petitioner will require a "lead time" of approximately 18 months from the time any Certificate of Need is issued in which to obtain equipment, construct a vault and ancillary facilities, and place the unit in operating condition. Although there are two separate hospital taxing districts in North and South Broward County that generally service the population in their respective geographic areas, projected need should be based on Broward County as an entirety because it is the designated "health service area." An 18 MEV linear accelerator can provide better treatment in a variety of types of cancer than other radiation therapy equipment presently in use in Broward County. Therefore, projected need should be based on Broward County requirements for such machines or its closest equivalent, the betatron. In 1980, there will one betatron and two 18 MEV linear accelerators in Broward County. The estimated population of Broward County in 1980 is 1,090,400. The incidence rate of cancer patients in Broward County is estimated at 490 per 100,000, which results in 4,910 projected cancer patients. Sixty percent of cancer patients are deemed to require radiation therapy and 40 percent of this number will benefit significantly from treatment by an 18 MEV linear accelerator or equivalent. Thus, 3,205 patients will require radiation therapy in Broward County and 1,282 will benefit from the specialized treatment of the higher voltage machines. At least 20 treatments will be required for the 1,282 patients. Based upon a predicted utilization rate of 3.5 patients per hour for the betatron and four patients per hour for the two projected 18 MEV's, the machines would be utilized in excess of 100 percent in 1980 for a forty-hour week. This does not make allowance for "down time" of the 18 MEV machines for maintenance or seasonal patient fluctuation. It is found from the foregoing that the extra high-voltage units that will be in operation in Broward County in 1980 will not be adequate to serve the needs of the county population and that therefore an additional 18 MEV linear accelerator to become operational during that year would not unnecessarily duplicate the existing resources. Consequently, a need will exist for an additional unit to be operational at that time.
Recommendation It is recommended that the Petitioner's application for Certificate of Need/Capital Expenditure Proposal be approved. DONE and ENTERED this 7th day of July, 1978, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Mr. Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 Chester Senf, Esquire Assistant General Counsel Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301 R. J. Fegers, Esquire 6011 Rodman Street Hollywood, Florida 33023 Clifford F. Anderson, Jr. Executive Director Health Planning and Development Council for Broward County 416 South West 1st Avenue Ft. Lauderdale, Florida 33301
The Issue Whether Petitioner is entitled to sit for the examination for licensure as a physician assistant.
Findings Of Fact Petitioner is an applicant to sit for the examination for licensure as a physician assistant in Florida. Petitioner relies on the provisions of Section 458.347(7)(b), Florida Statutes, which provide, in pertinent part, as follows: 1. . . . [T]he department shall examine each applicant who the board certifies: Has completed the application form ... Is an unlicensed physician who graduated from a foreign medical school listed with the World Health Organization ... Has applied for certification as a physician assistant in this state between July 1, 1990, and June 30, 1991. Was a resident of this state on July 1, 1990. . . Petitioner's application to sit for the examination for licensure as a physician assistant was denied by an Order entered by the Board of Medicine on March 12, 1992. The Order cited the following four grounds for the denial: The applicant (Petitioner) does not have a medical degree as required by Sections 458.347(b)1.b. and 458.311(1)(f)3.a., Florida Statutes. The applicant has been unable to provide adequate evidence that he was a resident in Florida on July 1, 1990. The applicant has failed to account for all time and activities on his application from July 1981 - May 1982. The applicant has failed to list all employment activities on his application when compared to the Resume of Qualifications he submitted. Petitioner attended medical school at the Universidad Central del Este (UCE) in the Dominican Republic from 1975 to 1981. Petitioner testified that he completed his assigned curriculum and that he participated in graduation exercises. Petitioner did not receive a diploma or a medical degree from UCE because he owed the university for tuition. In response to an inquiry from Respondent, the Dean of Medicine of UCE provided the following information: ... [W]hile it is true that [Petitioner] completed the curriculum of our School of Medicine, he has other requisites to be completed. Among these is an outstanding debt for registration fees at our University. Until this debt is satisfied he cannot be awarded the degree of Doctor of Medicine, nor can any documents be issued. Petitioner's application and the documentation he initially submitted in support thereof did not establish that Petitioner met the residency requirements of Section 458.347(7)(b)1.d., Florida Statutes. The evidence submitted at the formal hearing established that Petitioner was a resident of the State of Florida on July 1, 1990, and at all other times pertinent to this proceeding since that time. Petitioner, in his application for licensure, failed to set forth his activities between July 1981 and May 1982./1 Petitioner has subsequently provided that information to the Respondent. During that time, Petitioner was unemployed and studying for his medical examinations. Petitioner, in his application for licensure, failed to completely set forth his employment history, including his work as a medical health counselor and as a mental health supervisor. His employment history is required by the application form and should have been included as part of his application package. All information pertinent to his employment has now been provided by Petitioner.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order denying Petitioner's application on the grounds that he is not a graduate of a medical school recognized by the World Health Organization. DONE AND ORDERED this 28th day of July, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 28th day of July, 1993.
