Findings Of Fact Respondent, Randall B. Whitney, is a licensed medical doctor having been issued license number ME 000 8859 by petitioner, Department of Professional Regulation, Board of Medical Examiners. He presently resides in Port Orange, Florida and operates a family planning center in Daytona Beach. Respondent is a 1959 graduate of Tulane University Medical College. After interning at a Jacksonville hospital, he served three years in the U.S. Air Force as a flight medical officer and flight surgeon. He then took a two- year general residency in California. He began private practice in Mount Dora, Florida in 1965, the same year he received his license to practice in Florida. Although he was once board certified in family practice, he is not presently board certified in any specialty. He is not a member of the Florida or American Medical Associations and he does not hold privileges on the staff of any hospital. Prior to the initiation of this proceeding he did apply for emergency room privileges at a hospital in Daytona Beach but his application was denied. Therefore, he cannot admit patients to hospitals. When the events herein occurred, respondent had a financial interest in and was medical advisor to the Childbirth Center (CBC) in Daytona Beach. He also provided medical services on a contract basis to the Woman's Health Center (WHC) in Orlando and Holly Hill and the Aware Woman Clinic, Inc. (AWC) in Cocoa Beach. All four are birthing centers where women receive care and treatment during pregnancy and where the actual labor and delivery occur. Additionally, the facilities provide annual check-ups, IUD services, abortions, and advice for birth control. He divided his time between the four clinics, visiting each place one day of the week except the Orlando clinic, which he visited two days per week. In the spring of 1981, respondent became acquainted with one Eric Niederschmidt, an enlisted man stationed at Patrick Air Force Base who also worked weekends or nights at Aware Woman Clinic as an "assistant". Eric complained of pain in his knee from an internal knee derangement caused by stress and requested a pain medication to ease the pain. Whitney wrote several prescriptions for percocet between March and September, 1981. He also permitted Eric on several occasions to fill out the prescription pad, then bring it to him for review, and then sign the prescription. The evidence is conflicting as to whether respondent kept pre-signed blank prescription forms at the Aware Woman Clinic, which were later used by Niederschmidt to obtain drugs. Although respondent admitted he pre-signed such forms to a Department investigator during an interview in November, 1981, he denied he did so during the final hearing, and it is found the greater weight of credible evidence supports a finding that he did not. The CBC is not equipped to handle emergency situations or to care for "high-risk" pregnancies. Instead, it is designed to handle the routine low-risk pregnancy which has no complications. Indeed, the CBC has no internal monitoring devices, x-ray equipment or cesarean section devices, all of which are needed when complications in preqnancy set in. Its medical equipment consisted primarily of nitrous oxide and oxygen in large H-cylinder tanks with a nasal applicator mask, a fetal Doptone monitor to monitor for fetal heart tones, an Isolette to provide a controlled environment for babies distressed prior to transfer, outlet forceps, intracoths, emergency suction apparatus and the like. A supply of various kinds of medicine, including adrenalyn, ephedrine and pitocin were kept on hand. In 1979, one Joyce Ann Geeson became a patient of respondent at CBC. She was cared and treated for during her pregnancy in the months of June through a part of December, 1979. Around 3:30 a.m. on Saturday, December 8, 1979, Geeson awoke with ruptured membranes. She did not begin labor until almost 22 hours later. After labor pains commenced that night and early Sunday morning, Geeson reported to the CBC at noon on Sunday. After 38 hours of labor with little progress, Whitney ordered that pitocin be administered to Geeson. That drug serves to stimulate contractions of the uterus. However, this drug should only be used in a hospital setting since it can cause a tetanic contraction of the uterus and cut off the blood supply to the baby. It can also cause a rupture of the uterus. Therefore, it was inappropriate for Whitney to use pitocin in his facility. This is confirmed by instructions in the Physicians Desk Reference, 1979 edition, as to the use of the drug as well as uncontradicted expert testimony presented by petitioner. In Geeson's case the pitocin was continued for some 18 hours until a decision was made to transfer the patient to a hospital after the patient had made very little progress. Geeson was finally admitted to the emergency room at Halifax General Hospital around 11:10 p.m. on December 10, 1979. Whitney accompanied her to the hospital. When Geeson's temperature rose to 102.3 around 6:00 a.m. on December 11, she was immediately sent to the operating room where a C-section was performed. An examination of Geeson indicated her membranes had been ruptured for approximately 68 hours prior to admission to the hospital, that the patient had given signs of such a rupture by the excretion of a green tinged fluid (meconium), and that Geeson had stopped progress in delivering the baby some 24 hours prior to the hospital admission. Whitney's failure to recognize and properly handle premature rupture of the membranes, to promptly repond to meconium staining (which is a sign of possible fetal distress), and the use of pitocin in a non-hospitaL setting were deviations from the level of care, skill and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. Sandra Vigue was a 33 year old patient of the CBC in the fall of 1979. She first visited the clinic in her third trimester in September, 1979. Vigue told CBC personnel that her last menstrual period was mid-December, 1978 which would have indicated an expected date of confinement (EDC) of mid or late September, 1979. The clinic initially noted her EDC as being late September or early October. A nurse later noted in the records that on September 19 the patient was approximately 35 weeks gestation, or 5 weeks before the due date. When the baby had not come after weekly visits to the clinic in October, a nurse simply placed a question mark next to Vigue's EDC. By this time (42 weeks), according to expert medical testimony the fetus comes at high risk because of post-maturity syndrome. On October 21, 1979, Vigue began labor around 7:00 p.m. Around 8:30 p.m. a nurse noted the presence of a greenish substance being discharged in the vaginal area while performing an examination at Vigue's home. She noted in the patient records that it had the appearance of meconium. The nurse immediately telephoned respondent to report this finding. After a discussion, Whitney discounted the fluid as being cervical and not meconium. Meconium is, of course, an indication of fetal distress and that a membrane has prematurely ruptured. This in turn leads to a high-risk situation in terms of the delivery of the baby. Vigue remained at her home overnight and had no apparent progress in contractions. At approximately 1:00 p.m. the next day (October 22) Whitney requested she come to the clinic. She did so and was evaluated by him at 4:00 p.m. Whitney noted the passing of copious malodorous meconium and asked "why" in the charts. He then sent her to a local hospital where she was admitted at 7:50 p.m. the same day. Upon examination by hospital personnel, they noted premature rupture of the membranes and a discharge of meconium. Before further tests could be run, Vigue's condition deteriorated and she was given an emergency cesarean section. A stillborn infant was delivered. Respondent performed no post-maturity syndrome tests on Vigue that are normally given when a woman reaches an age of 42 weeks pregnancy. These tests are essential since a baby at that age may be under stress from lack of nutrients and oxygen. In this regard, he failed to conform to prevailing community standards for physicians. Vigue was apparently quite firm in not wanting her baby delivered in a hospital setting. However, a physician should advise the patient when high risks set in of the potential danger in not doing so, and if the patient refuses, document his records accordingly. Here, Vigue apparently held off until the last possible moment, but Whitney did not adequately document his records to show that he advised her of the potential dangers. Again, he failed to meet acceptable standards of skill, care and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. But since this was not a charge within the complaint, it is irrelevant. Finally, Whitney was negligent in the same respect by failing to recognize the meconium staining that occurred on October 21 and asking the patient for a history of rupture of membranes. In July, 1979, Lida Papa became a patient of CBC. Her estimated date of delivery had been established by CBC personnel as December 11, 1979. Papa suffered a ruptured membrane at 3:00 a.m. on December 22, 1979 or three full days prior to being admitted to a hospital. Her labor commenced on December 23. Because of slow progress, Whitney began administering pitocin to Papa around 7:25 p.m. on December 23 at a rate of 8 drops per minute, or a rate of 2 to 3 times that used initially in a hospital setting. The administering of the drug continued in larger dosages until the afternoon of December 24 when he allowed her to rest. It was restarted at 9:30 p.m. that evening and continued until 11:30 p.m. At the same time, the patient records of Papa reflect signs that the baby may have been in distress. She was also given ampicillin, presumably to counteract chills and fever being experienced around 1:30 a.m. on December 25. When her temperature reached 101 degrees Papa was sent to Halifax Memorial Medical Center, a Daytona Beach hospital. It was noted there that Papa had been at 9 or 10 centimeters dilation for some 18 to 19 hours prior to being transported to the hosptial. This is equivalent to complete dilation, and babies are normally delivered within two hours after complete or near complete dilation. Prudent medical care would have dictated that Whitney transfer Papa to the hospital no later than 24 hours after the membranes were ruptured if delivery had not occurred or was not imminent. This would have required admission to the hospital on December 23 rather than December 25. Whitney was also negligent in using pitocin in a non-hospital setting, and in dosages higher than is normally used. But this conduct was not described within the complaint and accordingly is irrelevant. Whitney failed to recognize that the patient was at high risk in a non-hospital setting because of the use of pitocin and the prolonged rupture of the membranes. In these respects, he deviated from the level of care, skill and treatment that would be recognized by a reasonably similar prudent physician as being acceptable under similar conditions and circumstances. Whitney was employed by the Women's Health Center, Inc. (WHC) in Orlando, Florida on a contract basis in 1978. He generally visited the Center either on Tuesday and Thursdays of each week, or Thursday only, depending on his schedule at other clinics. Whitney did not represent himself to the Center as being a urologist although he routinely performed vasectomy procedures. Daniel Hallman wished to have a vasectomy performed, and after searching through the Yellow Pages, selected the WHC. He talked by telephone with an unidentified lady at the Center and asked if the physician who would perform the vasectomy was a "licensed urologist." He was assured that Whitney was. Hallman then made an appointment to have the procedure performed on Thursday, November 16, 1978. On that afternoon, he visited the Center where he first saw a film on vasectomies which briefly touched on complications, procedures and care of patients. He had some preliminary work performed by a nurse and then met with Whitney. He was never advised by Whitney of the risks associated with the operation or complications that could result from the procedure. Whitney testified that although he normally counseled patients, he thought Hallman had "waived counseling in effect" because he was intelligent and seemed to be well-read on the subject. Whitney was not asked nor did he represent to Hallman that he was a "licensed urologist." After the procedure was performed, Whitney told Hallman he could not ride a bicycle to work for awhile and to avoid intercourse for several days. He did not tell him that swelling, bleeding and fever could occur. Hallman left, went home, slept and then awoke later that night with pain, swelling and bleeding. He called the Center and a nurse advised him to apply ice to stop the bleeding. He did so and went back to sleep. Later on, he awoke in extreme pain and noticed his scrotum had swollen to the size of a grapefruit. He again called the clinic asking for Whitney but was told Whitney lived in Cocoa Beach and was unavailable. The nurse told him to keep applying ice and he would be okay. When Hallman called a third time on Friday morning, the clinic then contacted Whitney who returned Hallman's call later that morning. Whitney told him he could see him if Hallman would drive to Cocoa. Whitney did not recommend he see another physician since he had no "back-up" in the area. Whitney advised Hallman to continue to apply ice and to see him when he visited the Center the following Tuesday. The following Tuesday, the two met and Whitney prescribed a pain killer (darvon), clipped a stitch and squeezed some dry blood out of the area. He noted it was the worst case of swelling he had ever seen. He also advised Hallman to take warm baths. The two never met again. When the pain killer became ineffective, Hallman contacted a urologist the following Saturday who treated him at the emergency room of an Orlando hospital. The physician found Hallman to have a low-grade fever and prescribed an antibiotic and pain killer. When the procedure was performed, Whitney had no local hospital privileges or a "back-up" physician to handle emergencies. Whitney testified he had no post-operative information to give to Hallman to read. He attributed the problem to a "nicked" varicose vein and stated that he has performed approximately 1,000 such operations routinely since 1965 without a patient ever being hospitalized. Had he considered there to be a danger of infection, he would have referred Hallman to an emergency room. Because Whitney had no back-up physician for Hallman to see should post-operative complications have arisen, he failed to meet the standard of care practiced by similarly prudent physicians in the community. The administrative complaint does not allege, and indeed there is no evidence, that the procedure was improperly performed. Respondent has safely delivered at least 1,000 babies during his medical career. He believed that Vigue, Papa and Geeson were carefully monitored and treated, and were timely transported to the hospital once their risk factors had escalated. In the case of Hallman, Whitney stated he would have seen the patient had he realized an emergency existed, and admitted him to an emergency room if necessary. He justified the use of pitocin on the grounds it was safely administered and the Physicians Desk Reference is not binding on physicians in all cases. Whitney no longer performs childbirths and is not associated with any of the clinics in question. Instead, he now confines his practice exclusively to family planning.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Subsection 458.331(t), Florida Statutes, on four occasions as more specifically set out above, and that his medical license be suspended for thirty days, a $2,500 administrative fine imposed, and that he be restricted from performing childbirths except in a hospital setting. All other charges should be dismissed. DONE and entered this 20th day of April, 1984, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of April, 1984. COPIES FURNISHED: Douglas P. Jones, Esquire John M. Bringardner, Esquire P.O. Box 2174 Tallahassee, Florida 32316 Jack R. Leonard, Esquire 800 North Highland Avenue Suite 202 Orlando, Florida 32803 Frederick M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(n), and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact Hammesfahr is a licensed physician in the State of Florida, having been issued Florida License ME 52212 on February 8, 1988. He is board-certified in neurology and pain management. Hammesfahr's office is located in Clearwater, Florida, where he maintains a practice treating patients who have had strokes. A stroke is a blockage of an artery in the brain that causes damage to the brain. As a result of the stroke certain cells within the brain will die, and the victim will develop a multitude of deficits, including paralysis, loss of vision, sensory loss, and memory problems. Between 1998 and 2000, Hammesfahr advertised his treatment for stroke patients and included the following statements in some of his advertisements: Using advanced technology, Dr. Hammesfahr has developed a sophisticated method to help restore blood flow to the damaged areas of the brain after a stroke. With increased blood flow to these areas, the brain can heal. Dr. Hammesfahr is the first physician to treat and successfully reverse the effects of stroke using vasodilators. These advertisements have appeared in Florida and in airline magazines, which travel throughout the country. In some of his advertisements, Hammesfahr indicated that based on an evaluation of the first 67 patients who went through the therapy 82 percent had major improvement, 11.9 percent had minor improvement, and 6 percent had no improvement. He further indicated that the study showing these results was peer-reviewed. Generally, Hammesfahr's treatment protocol is based on the concept of dilating blood vessels in the brain to optimize neurological function and neurological recovery. He uses vasodilator medications to dilate blood vessels in the brain and to increase blood flow into the brain. Various methods are used to monitor the therapy and improvement, including ultrasound, physical examinations, neuropsychological and physical therapy testing, EEG, transcranial Doppler, and blood pressure monitoring. Medications used to dilate the blood vessels include ACE inhibitors, calcium channel blockers, nitrates, alpha and beta blockers, and sympatholytics. After a stroke has occurred, brain cells in the center of the stroke are destroyed and cannot be revived. The area next to the stroke center is called the penumbra and consists of brain cells that are damaged and might recover. Hammesfahr does not claim that his treatment protocol can restore the brain cells that have been destroyed. He does claim that by using his protocol there may be some recovery in the damaged areas, where the blood vessels have restricted and narrowed. The medications dilate the vessels and increase the blood flow to the damaged areas. The recovery of a stroke patient consists of three phases: acute, subacute, and chronic. The acute phase occurs from the onset of the stroke to the next few days or weeks thereafter. The subacute phase starts at the end of the acute phase and lasts for approximately six weeks to three months. However, in certain cases it might last as long as 18 months. The chronic phase is the last phase, which commences at the end of the subacute phase and lasts for an indefinite period. Hammesfahr usually treats stroke patients who are in the chronic phase, but has also treated patients in the other phases of stroke recovery. When a patient contacts Hammesfahr concerning his stroke treatment, the patient will be sent a new patient package, which describes the phases of treatment, contains articles written by Hammesfahr concerning his treatment, and includes a fee schedule. Hammesfahr has different treatment plans from which the patient may choose to participate. The costs for the treatment vary according to the plan; the longer the patient is seen in Clearwater by Hammesfahr, the more costly the treatment. The average patient seen by Hammesfahr opts for the three-week plan. If a patient decides that he wants to be treated by Hammesfahr, the patient is required to see his primary care physician, provide the physician with the articles contained in the new patient package, and obtain his medical records from the physician. The primary care physician is to perform certain tests on the patient and give a medical clearance for the patient to travel to Clearwater, Florida, for treatment by Hammesfahr. The patient is also sent a package of materials, which includes a medical history form to be filled out by the patient and brought to Hammesfahr when the patient comes to Clearwater for treatment. When the patient initially presents for treatment at Clearwater, the patient is given an explanation of the treatment by Hammesfahr and his staff. Patients are advised that there are no guarantees that the treatment will be successful. An intake is performed to make sure that the needed forms are properly completed, including a history of the patient to determine that the patient's primary care physician has given the patient a clearance to come to Hammesfahr for treatment, and to review the medical records of the patient. A physical examination is performed on the patient. The patient is given a schedule for the time that the patient will be in treatment in Clearwater, and Hammesfahr's staff reviews the schedule with the patient. Tests are performed on the patient in Hammesfahr's office such as the transcranial Doppler ultrasound to generally determine the blood velocity. The patient is sent to Diane Hartley, a physical therapist, for testing of gross motor function, and to Dr. Alexander Gimon for neuropsychological testing. The tests given by Ms. Hartley and Dr. Gimon are standardized tests, for which the patient normally pays additional fees. The initial tests by Ms. Hartley and Dr. Gimon are given to form a baseline for a comparison with later test results. Those patients who are three-week patients will also have examinations by Ms. Hartley and Dr. Gimon at the end of their treatment period. The test results are compared with the test results taken at the beginning of the treatment period. The patient receives an orientation session in which the patient is informed of the responsibilities that the patient has during the course of treatment. Such responsibilities include taking blood pressure measurements at prescribed times of the day, charting the results of the blood pressure test, and seeing and providing the patient's primary care physician with the blood pressure readings. The patient must drink eight glasses of water a day, unless the patient has a heart disease, and must avoid certain types of foods that are vasoconstrictors. Once the patient completes the treatment at Hammesfahr's office, the primary care physician will take over the medical management of the patient's treatment. Hammesfahr's office will confer with the patient's primary care physician after the patient leaves Hammesfahr's office to discuss the monitoring of the patient and the altering of the patient's medication. One week after returning from treatment in Clearwater with Hammesfahr, the patient must see his primary care physician. In October 1999, a friend of M.T. mailed M.T. one of Hammesfahr's advertisements. As result of receiving the advertisement, M.T. contacted Hammesfahr's clinic and sought treatment from him for a stroke which she suffered in May 1999. Hammesfahr sent M.T. an information package and a videotape. The package contained articles written by Hammesfahr, a description of the different programs available, and a price list for the programs. M.T. decided that she would try a three-day program for $3,000. There was a dispute as to exactly which program M.T. received when she went to Clearwater. The only two programs which Hammesfahr listed as costing $3,000 were the Executive Stroke Prevention Program and the One-Week Evaluation and Treatment Program. The Executive Stroke Prevention Program was described as follows: This is a three (3) day program in which patients will undergo CAT scan and MRI at our facility, state of the art computerized EEG, and transcranial ultrasound to look at the blood vessels of the brain. They will undergo a comprehensive medical review and family review, as well as recommendations for lowering one's chances of a stroke or to treat if there has been a stroke in the past. This program is not covered by insurance. The One-Week Evaluation and Treatment Program was described as follows: This program is designed for those who want to start the stroke program and have the program advanced to a level which makes it significantly easier for the family physicians at home and neurologists to continue the program safely and rapidly. The first days [sic] involved in the initial evaluation, as well as any testing such as EEG and ultrasound testing, if necessary, and CT scans and MRIs as well as blood tests, followed by days two through five being involved in the initiation of medical treatment in that either treating the previous stroke or preventing future strokes. Recommendations are then made to the family physician or neurologists for caring through on this program. There was an additional three-day program, Initial Evaluation and Treatment, which listed for $2,000 and provided the following: This is a three (3) day consultation and evaluation with recommendations for treatment. This program is designed for patients who are interested in treatment of their stroke by their family physicians at home. A comprehensive evaluation will be made by our physicians as well as treatment recommendations. This evaluation will include review of CAT scans or MRIs and blood tests, and when appropriate, computerized EEG testing, neuropsychological testing, and ultrasound evaluations. The program is approximately three days. Prior to traveling to Hammesfahr's clinic, M.T. was directed by Hammesfahr to obtain medical tests from her primary care physician, which she did. The tests included a CT scan of the brain, a CMP, liver profile, CBC with different platelets, Westergren's sed rate, EEG, CVA, and EKG. She was also required to take and write down her blood pressure two times a day for a week before going to Hammesfahr's clinic. M.T. also filled out a medical history form and a system review checklist prior to her visit to Hammesfahr. In a letter dated February 12, 2000, to M.T. on Hammesfahr's letterhead, his office staff described the treatment that M.T. would receive as follows: Your first visits with us will be quite long. So, plan accordingly. On your first day, you will have a consultation with the doctor. The second day you will have diagnostic testing in our office, and an appointment with Dr. Gimon for a neuro- psychological evaluation and Diane Hartley for a physical therapy evaluation. Both of these doctors will be calling you to set up these appointments. The neuro-psychological testing will help us to evaluate any memory changes. You will probably see Dr. Gimon again towards the end of your treatment. On Tuesdays and Thursdays there is an orientation session outlining what we will be doing here in the office and [sic] explaining our treatment program will be given out. Each new patient must attend one of these sessions. Every day thereafter, your visit will be at least two (2) hours long. As you know, our treatment consists of sessions in this office each day Monday through Friday for the duration of your therapy. Please note: No warranties or guarantees can be made regarding the time, the degree, or the duration of improvement with this therapy. On February 20, 2000, M.T. signed a Waiver for Use of Medications, which stated: I am, or my caregiver is, aware that I have had a neurological disease and have failed to respond to other types of medications used in the conservative management of my condition. . . . Options available to me at this time are those now used at the Florida Neurological Institute. I am aware that the medications used in this therapy are medications that have FDA approval. However, I am also aware that the FDA has not approved these medications in the doses and number of medications used here at the Institute. I am aware that Dr. Hammesfahr has published many articles on his therapy. I am aware of the fact that, during the past two years, the Institute has treated many patients with similar conditions and that most have had at least some improvement in the symptoms associated with their problem. I have, and my caregiver has, been counseled regarding this theory under which this therapy is being promulgated. Upon arrival at the Florida Neurological Institute, I and my caregiver, will see and listen to the videotapes available regarding this therapy. I have, or my caregiver has, read this waiver and understands its contents. I am, and my caregiver is, aware that there is no indicated use for this therapy now. I have had all questions I may have concerning the use of these medications answered, I agree to undergo the use of these medications as outlined in the material presented to me. As stated above, I am fully aware of the fact that this therapy probably will not be covered by my insurance, but I wish to continue with this therapy as outlined to me in my training and information sessions. I also understand that no physician, or any other person in this office, can make any guarantees of success from this therapy. (Emphasis in the original) On February 28, 2000, M.T., accompanied by her husband, presented to Hammesfahr's clinic in Clearwater, Florida, for treatment. On her first day at the clinic, she received an orientation. She was required to pay $3,000 for her treatment. A staff member at Hammesfahr's clinic took M.T.'s blood pressure and directed M.T. to take her own blood pressure readings thereafter. On the second day of treatment, February 29, 2000, M.T. was sent to Dr. Alexander Gimon, a neuropsychologist, for a 30-minute evaluation. A staff member of Hammesfahr's clinic gave M.T. a transcranial Doppler, a carotid artery ultrasound, and an electrocardiogram. A Physician's Office Visit History and Physical Examination Form was filled out with a date of "2-28-00" struck through at the top of the form and the date of "2-29-00" placed next to it. At the end of the form appeared a physician's statement signed by Hammesfahr and dated February 22, 2000, a week before M.T. presented for treatment, stating that he had "examined this patient, reviewed his/her history, and consulted with him/her and the caregiver regarding the treatment planned here at Florida Neurological Institute." An Objective (Physical Examination) form was filled out, again with the date of "2-28-00" struck through at the top of the form and the date "2-29-00" placed next to it. The form does not indicate who performed the physical examination. The form does indicate that M.T.'s blood pressure and pulse readings were taken. M.T. met with Hammesfahr, who observed her gait and told her that he would send her back home and would work with her physicians. He did not prescribe any medications at that time and did not give M.T. any medications during her treatment at his clinic. On March 1, 2000, M.T. was supposed to meet with the physical therapist, Diane Hartley, for evaluation at 8:00 a.m. When she arrived at Ms. Hartley's facility, no one was there to let M.T. in the building. When M.T. went into the facility, she did not like the looks of the building, describing it as "shoddy looking." She decided that she did not want to stay for an evaluation and left. The fee Hammesfahr charged M.T. included the fees for Dr. Gimon and Ms. Hartley. On March 1, 2000, M.T. and her husband returned home with the understanding that Hammesfahr would be contacting her doctors in Alabama to arrange for the administering of the medications. M.T. was told to make an appointment with her primary care physician for the week after she returned from Clearwater. Hammesfahr first communicated with M.T.'s physicians by letter, dated April 5, 2000, asking them to administer the vasodilators and magnesium sulfate I.V.'s. M.T.'s physicians in Alabama refused to administer the medications. M.T. did not take the vasodilators, which Hammesfahr wanted her physicians to administer; nevertheless, M.T. improved. Based on the rate schedule presented to M.T. for Hammesfahr's various treatment programs, she should have received either the Executive Stroke Prevention Program or the One-Week Evaluation and Treatment Program. Hammesfahr was adamant that M.T. did not sign up for the Executive Stroke Prevention Program, and the evidence established that she did not receive this program. M.T. was given an itinerary that indicated that she would be treated by Hammesfahr for a week; however the evidence established that she did not receive the treatment that was supposed to be given in the One-Week Evaluation and Treatment Program, which promised that the initiation of medical treatment would be done on days two through five. Hammesfahr did not administer any medications or prescribe any medications for M.T. during her stay in Clearwater. The evidence does show that M.T. received the three-day Initial Evaluation and Treatment Program, for which she should have been charged only $2,000. Hammesfahr presented the expert testimony of Dr. Jacob Green, who is a board-certified neurologist, practicing in Jacksonville, Florida. He has been practicing for over 35 years. Dr. Green has written papers on the use of transcranial Doppler, and he is experienced in the treatment of acute and chronic stroke patients. Dr. Green is familiar with the protocol and procedure utilized by Hammesfahr in treating stroke patients. He has read articles written by Hammesfahr, reviewed patients' records, and spent a day in Hammesfahr's office observing Hammesfahr's practice and treatment protocol which is at issue in this case. While he was at Hammesfahr's clinic, Dr. Green observed Hammesfahr treat patients, reviewed medical records of patients when they first came to Hammesfahr for treatment, and compared the findings in those records to his observations of the patients' abilities. Dr. Green discussed the treatment and protocol with Hammesfahr. Based on his deposition testimony, Dr. Green had a good understanding of the treatment and protocol used by Hammesfahr for stroke patients. Dr. Green described the standard of care for a stroke patient as "to do good by the patient, do no harm." According to Dr. Green, Hammesfahr's care and treatment and protocol complied with the standard of care. Hammesfahr presented the expert testimony of Dr. William Scott Russell, Jr., a retired neurologist with 33 years of experience. In his practice, he had treated thousands of stroke patients. Dr. Russell retired in October 1998. Dr. Russell had first-hand knowledge of the protocol used by Hammesfahr when he treated Dr. Russell for an acute stroke. Prior to Dr. Russell's being treated by Hammesfahr, Dr. Russell had reviewed a paper written by Hammesfahr concerning Hammesfahr's treatment protocol for stroke victims using vasodilators. Dr. Russell considered the treatment protocol espoused by Hammesfahr to not be below the standard of care as of 1998. In 1996, Dr. Russell experienced a stroke. When he awoke one morning, he was confused. He went to work and had difficulty with his abilities to speak and write. Dr. Russell realized that he was experiencing a stroke and had a technician in his office run an EEG. He had peer-reviewed some of Hammesfahr's papers prior to his stroke and was impressed with Hammesfahr's work. So, he contacted Hammesfahr and presented at Hammesfahr's clinic for treatment the day he experienced the stroke. Hammesfahr performed a transcranial Doppler on Dr. Russell and administered nitroglycerine to dilate Dr. Russell's blood vessels. Ten minutes after the nitroglycerine was administered, Dr. Russell's symptoms disappeared. Within a reasonable degree of medical probability, the cause of his recovery was the use of the nitroglycerine. Nitrates are used for acute stroke patients when the patient has an extremely high blood pressure. The nitrates lower the blood pressure and are given intravenously so that the medication can be discontinued immediately if the blood pressure should fall too low. There was no evidence presented to determine whether at the time that Hammesfahr administered nitroglycerine to Dr. Russell that Dr. Russell's blood pressure was high. At the time of the final hearing, Dr. Russell felt that he had total recovery from the stroke deficits. He has reduced his intake of medications prescribed by Hammesfahr and has not had a return of the deficits. The Department presented the testimony of four expert witnesses concerning the standard of care for treatment of stroke victims: Dr. Harold Charles Friend, Dr. Steven Novella, Dr. David F. Scales, and Dr. Thomas Hoffman. Dr. Hoffman has been practicing neurology in Melbourne, Florida, since 1982. Approximately five to ten percent of his patients have had a stroke or a cerebral vascular disease. He has read some of Hammesfahr's advertisements and viewed Hammesfahr's article on Hammesfahr's Internet web site. Dr. Hoffman understands Hammesfahr's protocol to be the use of medications to increase the cerebral blood flow and the use of the transcranial Doppler to direct the medication treatment by measuring the cerebral blood flow. Dr. Hoffman does not agree that the use of vasodilators increases the blood flow to the brain. There is a loss of cerebral autoregulation when a stroke occurs. According to Dr. Hoffman, the use of vasodilators can decrease the blood flow to the brain and worsen neurological functioning in acute stroke patients. It is the opinion of Dr. Hoffman that Hammesfahr's treatment of stroke patients falls below the standard of care for acute, subacute, and chronic stroke patients. Dr. Steven Novella is a neurologist and an assistant professor at Yale University. He received his medical license in Connecticut in 1993 and obtained his board certification in neurology in 1998. He treats stroke patients and is familiar with the appropriate treatment for stroke patients. Dr. Novella understands that the treatment for stroke patients which Hammesfahr advocates is the administration of vasodilators to expand blood vessels which have an insufficient blood supply due to constriction. He disagrees with Hammesfahr's theory, espousing that the blood vessels in the area of the brain that is not receiving enough blood flow will dilate as far as they can go and that the blood vessels will not respond to the vasodilators because the blood vessels are already maximally dilated. Dr. Novella is of the opinion that vasodilators may be used for stroke patients to reduce the risk of another stroke when the patient is hypertensive, but that the vasodilators should not be used as a method of reversing deficits caused by stroke. Dr. Harold Charles Friend is a board-certified neurologist, who has been practicing neurology for 26 years. He practices in Boca Raton, Florida. Approximately five to eight percent of his practice is dedicated to treating stroke patients. He is currently treating in excess of 500 stroke patients. Dr. Friend has reviewed the charts of two patients of Hammesfahr, an article written by Hammesfahr, some of Hammesfahr's advertisements, some newspaper articles, and an article authored by Hammesfahr, which appeared on an Internet site. Dr. Friend also saw a patient in his office that had previously been treated by Hammesfahr. Based on the information from these sources, Dr. Friend incorrectly understood that Hammesfahr's methodology was to basically lower the blood pressure of his patients in an attempt to restore dead cells. He also concluded that the patients seen by Hammesfahr were also receiving physical therapy at the time of treatment. Dr. Friend opined that Hammesfahr's treatment of chronic stroke victims did not comport with the standard of care recognized in the medical community. He further concluded that given the medications that Hammesfahr administers to his patients, that one would expect some adverse effects or no effect on the patients. The only mention in the record of a patient's being harmed by Hammesfahr's treatment was by Dr. Friend. Dr. Friend reviewed a medical chart of a patient who had worsened after treatment by Hammesfahr and had to go to another physician, Dr. Nassar Elmansoury, to correct the problem. The patient had been prescribed Accupril, ten milligrams four times a day, and nitroglycerine cream. Both medications are vasodilators. When the patient presented to Dr. Elmansoury, the patient was feeling worse and experiencing chest pain, dizziness, and disequilibrium. Dr. Elmansoury eliminated the nitroglycerine cream and reduced the amount of Accupril. Within two weeks, the patient was improved. Dr. David F. Scales is a board-certified neurologist, who has been practicing for 34 years. He currently practices in the Jacksonville, Florida, area at the Jacksonville Neurological Clinic. About 50 percent of his in-patient practice consists of stroke patients. Stroke patients comprise about 20 to 25 percent of the entire practice. Dr. Scales has reviewed the medical records of two of Hammesfahr's patients, articles written by Hammesfahr, literature provided by Hammesfahr to his patients, and Hammesfahr's Internet web site. Dr. Scales understands Hammesfahr's theory to be that vasodilators are administered to dilate the blood vessels in the brain so that more blood flows through the penumbra, reactivating neurons that were in a suspended state of activation. He does not agree with Hammesfahr's theory because the blood vessels in the penumbra would be dilated to the maximum and the medications would dilate blood vessels in other parts of the body, which would in turn take away or steal the blood flow from the blood vessels in the penumbra. After reviewing the medical records of two of Hammesfahr's patients, M.T. and M.S., Dr. Scales was of the opinion that the treatment provided by Hammesfahr did not meet the standard of care for the treatment of stroke patients. Having considered the testimony of the experts presented by the parties, it is determined that the standard of care for the treatment of stroke patients varies according to the stage, type, and severity of the stroke. In the acute stage, the patient is admitted to the hospital. A medical history is taken and a physical exam is given, followed by appropriate laboratory and imaging studies to determine the site and cause of the stroke. For patients seen within three hours of the onset of the stroke, certain intravenous medications may be given in an attempt to break up the blood clot. For patients seen beyond the three-hour point, the treatment is maintenance of their blood pressure, monitoring of their vital signs, and treating any complications that may occur such as pneumonia and urinary tract infections. Patients may be given blood thinners to improve the flow of the blood, and medication to increase the blood pressure in the event the blood pressure is too low. Patients with severe hypertension, generally a blood pressure over 220 systolic or 120 diastolic, are given medications to lower their blood pressure. Patients with asymptomatic hypertension are treated judiciously during their hospital stay with anti-hypertensive medications, and the blood pressure is gradually lowered. The standard of care for subacute stroke patients is a continuation of the treatment given in the acute phase. Patients will be started on rehabilitation therapy, which may include speech, occupational, and physical therapy. The standard of care for chronic stroke patients, whom the physician is seeing for the first time, would be to take a history to determine what happened, review the medical records and any imaging studies that may have been done, and review the treatment they have had. The physician should assess the patients' risk factors for stroke such as hypertension, hyperlipidemia, diabetes, and smoking and manage those factors aggressively. Treatment with antiplatelets such as aspirin or an anticoagulation medication might be indicated. An assessment of their neurological functional abilities should be done to determine whether aids, braces, further therapy, or home care could be beneficial. Based upon the evidence presented, the treatment advocated by Hammesfahr is not within the generally accepted standard of care. However, the evidence is not clear and convincing that the treatment used by Hammesfahr is harmful to his patients. There is literature in the medical community that vasodilators can be used in the treatment of stroke as a measure to prevent future strokes. There is evidence that in over 200 patients seen by Hammesfahr that a large percentage improved after being treated by Hammesfahr. Dr. Gimon tested a group of 168 stroke patients seen at Hammesfahr's clinic during the period of November 1999 to May 2000 and another group of 163 stroke patients seen during October 2000 through February 2001. The same battery of tests was administered to both groups. Dr. Gimon evaluated these patients on nine separate neurological evaluations that are standard instruments recognized in neuropsychology. The tests measured identified areas of brain function, including verbal, visual, visual motor, and conceptual thinking. Both groups of patients were tested prior to the treatment by Hammesfahr. The patients were tested again approximately 18 to 21 days after they began treatment at Hammesfahr's clinic. The test results showed that many patients showed improvements in the areas tested. The improvements noted were measured as to a statistical difference so that the findings could not be attributable to testing error. Some patients showed no improvement in all areas. The test results revealed that there was no neuropsychological deterioration of the patients tested. Diane Hartley tested two groups of Hammesfahr's patients, who were treated at his clinic during the period of January to December 2000. Her tests were designed to measure functional motor improvement from a gross motor standpoint. She performed tests on the patients prior to their beginning treatment with Hammesfahr and again approximately two and one half to three weeks after the patients had begun treatment. Of the 242 patients tested by Ms. Hartley, 221 patients demonstrated improvement in one or more of the areas tested and 21 patients showed no improvement. Of the patients tested, ten received physical therapy from Ms. Hartley while they were being treated by Hammesfahr. These ten patients demonstrated a significant amount of improvement, which Ms. Hartley could not attribute solely to the physical therapy they received. The evidence establishes that Hammesfahr informed his patients by the use of videos, orientation sessions, literature, and a web site on the Internet of the nature of the therapy and did not guarantee that the patients would improve as a result of the treatment. Patients were able to make an informed decision on whether to try Hammesfahr' treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Hammesfahr did not violate Subsections 458.331(1)(d) and 458.331(1)(t), Florida Statutes; finding that Hammesfahr did violate Subsection 458.331(1)(n), Florida Statutes; placing Hammesfahr on probation for six months; and imposing a $2,000 administrative fine. DONE AND ENTERED this 20th day of November, 2002, in Tallahassee, Leon County, Florida. _____ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of November, 2002.
Findings Of Fact "[HRS] has adopted a Rule 10-5.08, F.A.C., which makes provision for the review of CON applications in specific time sequences, known as "batching cycles." The purpose of this rule was to implement the statutory mandate of ss. 381.494(5), Florida Statutes, which required that: The Department by rule shall provide for the applications to be submitted on a timetable or cycle basis, provide for review on a timely basis; and provide for all completed applications pertaining to similar types of services, facilities, or equipment affecting the same service district to be considered in relation to each other no less often than four times a year. Rule 10-5.08, F.A.C., states that the letter of intent and application schedules were established "[i]n order that applications pertaining to similar types of services, facilities, or equipment affecting the same service district may be considered in relation to each other for purposes of competitive review. "Under Rule 10-5.08, F.A.C., June 15, 1984, was the beginning of a batching cycle for "hospital projects" that included certificate of need requests by hospitals for cardiac catheterization laboratories and open heart surgery programs. To enter a batching cycle, an applicant must first have filed a letter of intent ("LOI") with [HRS] and the Local Health Council at least thirty (30) days prior to filing an application. The LOI deadline for the June 15, 1984, batching cycle was thus May 16, 1984. There was, however, one exception to this requirement of filing an LOI thirty (30) days in advance. This exception, known as the "grace provision," was found at Rule 10 5.08(e), F.A.C. In cases where a letter of intent was filed within five working days of the letter of intent deadline, a grace period of 10 days from the deadline date for receipt of letters of intent shall be established to provide an opportunity for a competing applicant to file a letter of intent. "On or about May 14, 1984, St. Mary's Hospital in West Palm Beach submitted a letter of intent to file a CON application for a cardiac catheterization laboratory and an open heart surgery program. St. Marys' [sic] LOI was for entry in the June 15, 1984, batching cycle. This date of Nay 14, 1984, was within five (5) working days of the LOI deadline for the June 15, 1984, batching cycle. "Boca Raton Community Hospital [also] filed a letter of intent to apply for a CON for cardiac catheterization and open heart surgery. Boca Raton's LOI was filed in April of 1954, a time period greater than five (5) working days prior to the LOI deadline. "On May 29, 1984, Good Samaritan filed with [HRS] and the Local Health Council a letter of intent to establish cardiac catheterization and an open heart surgery program in order to compete for CON approval with the similar services proposed by St. Marys [sic]. Good Samaritan's May 29, 1984, LOI sought entry into the June 15, 1984, batching cycle. "May 29, 1984, was within ten (10) days from the deadline date for receipt of letters of intent for the June 15, 1984, batching cycle. "Good Samaritan does not view itself as directly competing with Boca Raton Community Hospital for patients or services due to the distance between these facilities. Good Samaritan does view itself to be in direct competition with St. Marys [sic]. All three hospitals are, however, in the same HRS Service District and [HRS] reviews CON applications for cardiac catheterization laboratories and open heart surgery on the basis of whether there is a need for such laboratories or programs in the service district. "On June 15, 1984, Good Samaritan submitted its [CON] application to [HRS], together with the required Four Thousand Dollar ($4,000.00) application fee. [HRS] refused to accept this application for review in its June 15, 1984, batching cycle and returned the application and the filing fee to Good Samaritan. [HRS] advised Good Samaritan that the next batching cycle it could enter for this application would be the October 15, 1984, batching cycle. "Good Samaritan timely filed a request for formal proceedings pursuant to ss. 120.57, Florida Statutes (1983), regarding [HRS's] refusal to accept its application in the June 15, 1984, batching cycle. The Division of Administrative Hearings has jurisdiction over the parties and over the subject matter of this proceeding. "Effective September 6, 1984, and subsequent to the Department's refusal to accept Good Samaritan's application for the June 15, 1984, batching cycle, [HRS] amended Rule 10-5.08(e). The new rule, as amended, reflects the requirements that the Department contends are applicable to Good Samaritan in this case prior to the amendment. "[HRS's] refusal to accept Good Samaritan's application in the June 15, 1984, batching cycle prevents Good Samaritan from having its proposed project reviewed comparatively and competitively with St. Marys' [sic] or Boca Raton's similar proposals, because [HRS] does not review CON applications comparatively and competitively unless they are filed in the same batching cycle. "[HRS] approved in part [sic] both St. Marys' [sic] and Boca Raton's CON applications. CON #3367 was issued to St. Marys [sic] for a cardiac catheterization laboratory and CON #3366 was issued to Boca Raton for a cardiac catheterization laboratory. These actions by [HRS], however, have not yet become final and are subject to formal administrative hearings requested by Good Samaritan. "[HRS] takes the position that the approvals of the cardiac catheterization laboratories at St. Marys [sic] and Boca Raton count against the need for an additional cardiac catheterization laboratory as proposed by Good Samaritan if Good Samaritan's application is considered in a later batching cycle."
Recommendation Based on the foregoing, it is RECOMMENDED: That HRS enter a final order requiring that Good Samaritan's CON application be reviewed in the June 15, 1984 batching cycle. DONE and ORDERED this 13th day of February, 1985, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of February, 1985.
The Issue Is there a factual basis for the imposition of the March 7, 1996 moratorium upon admissions to Petitioner's assisted living facility (ALF), pursuant to Section 400.415 F.S.?; and Is there a basis for continuing the moratorium?
Findings Of Fact ALFs are defined in Section 400.402(3) F.S. They must apply for, and be granted, a license or provisional license to operate by AHCA pursuant to the terms of Section 400.411 F.S. There is no clear evidence in this record whether Semanole Brook Assisted Living was licensed to operate under Section 400.412 F.S. by a full or provisional license. The best sense of the evidence as a whole is that Semanole Brook was operating in the first five months under some type of licensure. This case arises because AHCA imposed a moratorium upon admissions on March 7, 1996. Moratoriums on admissions to ALFs are to be imposed pursuant to Section 400.415 F.S. Administrators of ALFs or their designees are trained under a program administered by the Department of Elder Affairs (DOEA). Intensive training is provided over the course of four days, and includes an introduction to the licensure and survey process, appropriateness of admissions, fire safety, food safety, nutrition, aging, mental health, behavior issues, resident rights, medication management, abuse reporting, developmental disabilities, community resources, emergency management, and the role of the long-term care ombudsman. This training is referred to as "core training". In the course of care training, participants are given a copy of the administrative rules and Florida Statutes applicable to ALFs. Participants are also given a copy of survey guidelines used by AHCA. In the course of care training, participants are advised of the requirement than an ALF have a written contract with each resident of the ALF. Core training is offered quarterly. Elizabeth McCorvey attended care training for Petitioner's ALF, Semanole Brook Assisted Living Facility, in September and October, 1995. She was permitted to represent the facility in these proceedings upon evidence that she is the sole employee and administrator of Semanole Brook. Any qualifications or certifications of hers are attributable to the facility and vice-versa. Ms. McCorvey missed that portion of care training in September 1995 which concerned medications, and therefore she did not earn a certificate of completion at that time. Rather than making her wait until the next full training session, DOEA officials agreed to allow Ms. McCorvey to come to the premises where training was provided, and there to listen to an audio tape of the portion of care training she had missed in September 1995. She did not follow up on this accommodation to her schedule and instead attended that portion of the January 1996 care training which concerned medication. She received a certificate of completion of care training on February 8, 1996. The topics which were covered with Ms. McCorvey in her core training were those described in Finding of Fact 4 supra. All such topics, with the exception of medications, were covered with Ms. McCorvey in September and October 1995. A six hour update to core training was offered by DOEA in December 1995, concerning the administrative rules for ALFs. At formal hearing, Ms. McCorvey had admitted a certificate showing she completed this course. Core training may be repeated if a given participant is asked to repeat it or if the participant requests to repeat it. Respondent conducted a complaint investigation of Semanole Brook on March 6, 1996. Respondent's survey team was composed of Kathryn Rowland, Betty Cettie, and Shawn Rogers. At the time of this investigation/survey, the residents previously on the premises had already been relocated elsewhere. They were not removed by Petitioner or AHCA. In the course of the complaint investigation of March 6, 1996, the AHCA survey team asked to see the admission/discharge register for residents of Semanole Brook. Ms. McCorvey did not produce an admission/discharge register. Records pertaining to four residents of Semanole Brook were produced by Ms. McCorvey on March 6, 1996. Two of the records indicated that no health assessment was done for either resident prior to admission into Semanole Brook. The health assessments which had been made for the other two residents indicated that neither resident was appropriate for placement in an ALF. In the course of the complaint investigation of March 6, 1996, Respondent further found that Semanole Brook's written contracts for residents were deficient in that the standard form did not state the exact services that the facility was to provide to residents, did not identify rates for payment, did not provide for 30 days' notice prior to an increase in rates, and did not state the facility's policy regarding advance payments or refund of payments. In the course of the complaint investigation of March 6, 1996, Respondent further found that Semanole Brook had no written records for income and expenses. Respondent's survey team was told by Ms. McCorvey that she relied upon memory to keep track of the facility's income and expenses and did not consider documentation of income and expenses necessary. In the course of the complaint investigation of March 6, 1996, Respondent further found that Semanole Brook's admissions packet (given to residents upon admission to the facility) did not include the facility's rules and regulations, nor the facility's admission, retention, and discharge policy, nor the facility medication storage policy. In the course of the complaint investigation of March 6, 1996, Respondent further found that Semanole Brook's resident care standards were deficient. Ms. McCorvey admitted to surveyors and at formal hearing that she had locked herself in her bedroom at night with a loaded gun she had owned before opening the facility. She testified that almost everyone "has a gun" these days, particularly single women like herself. She explained her behavior with the gun and the locked bedroom door as due to her fear of one particular resident, whose past medical history, if it had been properly assessed, would have shown the patient was not suitable for ALF placement due to violent tendencies. Ms. McCorvey only locked herself in her room after she discovered the patient had been released from a psychiatric hospital where he had been placed for three years after beating up a police officer. Inquiries at the time of the investigation showed Ms. McCorvey did not know at that time she could refuse certain types of patients. By the date of formal hearing, Ms. McCorvey understood she could refuse certain patients but was still vague about how to go about refusing to admit them. She still did not seem to appreciate that locking herself in her room left other residents potentially in harm's way and meant she was unavailable to assist them even with usual tasks. Records for a resident identified as T.W. indicated that T.W. was admitted to Semanole Brook against medical recommendations, that T.W. was in need of skilled nursing care, and that T.W. was therefore inappropriately placed in a ALF. Betty Jean Cettie, a member of Respondent's March 6, 1996 survey team, is a human services surveyor specialist with AHCA. She has a B.S. degree in Health Care Administration and is licensed in Florida as a Nursing Home Administrator. She is a fellow of, and certified by, the American College of Health Care Administrators. By education, training and experience, she is an expert in the field of long term sub-acute health care. No contrary expert testimony was presented, and Ms. Cettie's testimony and opinion are fully accepted to the effect that Ms. McCorvey, as administrator of Semanole Brook, at the time of the survey did not understand the requirements for admission to ALFs, had no understanding of one patient's dietary and medication needs, and that Ms. McCorvey needed further training as an ALF administrator if Semanole Brook was to operate safely. Nothing presented at formal hearing would alter this determination. Ms. McCorvey testified regarding the four residents of Semanole Brook whose records were reviewed by Respondent's survey team. Resident T.W. was "a head injury client" who "walked around the house in his underwear." Resident C.W., the facility's first resident, "wandered off." Resident J.R. would "not fill out any kind of demographic data" other that what Ms. McCorvey "had written at the Tallahassee psychiatric unit," and was described as "paranoid". Resident E.E. also "wandered", and Ms. McCorvey was a "little confused with the back of the boxes that her doctor had checked out from PATH". The boxes as checked on the form would show inappropriate placement. E.E. was never formally discharged, but "wandered off" on February 21, 1996. Ms. McCorvey admitted personally witnessing E.E. leaving Semanole Brook, and testified that she was "not responsible or whatever" because "according to the law they can wander off if they want to, you know." The deficiencies identified by Respondent's survey team during the complaint investigation of March 6, 1996 were documented on a statement of deficiencies. Although Ms. McCorvey has complained that she did not receive the statement of deficiencies at the appropriate time, the evidence shows she knew about all of the assessments of deficiency at all times material. It is specifically found that she received adequate notification in a timely manner. Based upon the deficiencies found on March 6, 1996, Respondent imposed an immediate moratorium upon admissions to Semanole Brook on March 7, 1996. Based upon the deficiencies as found on March 6, 1996, Respondent recommended that the administrator of Semanole Brook undergo further training in the operation of an ALF and correction of the listed deficiencies. A follow-up survey was conducted of Semanole Brook by Respondent on April 6, 1996. It was determined on April 6 that the deficiencies found on March 6, 1996 had been corrected, with the exception of those relating to inappropriate placement of residents, additional training for the facility administrator, and resident care standard. With the exception of the additional training, which must precede admitting patients to the facility, the other two deficiencies usually are checked by AHCA after the facility is reopened because the residents can be surveyed then. That is certainly the only way it could be done in this case since there are no residents or resident records to review now that the facility is empty. By letter dated April 15, 1996 AHCA continued the moratorium imposed on March 7, 1996, conditioned upon further training being completed by Ms. McCorvey as Semanole Brook's administrator. The recommended training is a repeat of the care training which lasts four 6-hour days. Ms. McCorvey's testimony is not clear as to her prior experience. It may be that she assisted her parents with some type of charity work, but she apparently has no prior work experience operating a health facility. When it was operating, Ms. McCorvey was Semanole Brook's sole employee. Ms. McCorvey declined to testify as to how she is currently employed or to give much information about how she can be located. She testified that to support herself she is presently, "doing the same miscellaneous thing and whatnot", and stated that she considers the imposition of additional ALF training to be discriminatory and selectively enforced against her facility. Further, she finds such training to be so time-consuming as to be financially oppressive. However, she gave no concrete reason as to why she does not have time to repeat the training nor evidence of selective enforcement beyond uncorroborated hearsay and her personal opinion. By letter dated April 23, 1996, Ms. McCorvey substantially disagreed with the condition of further training, describing the same as "punishment", an opinion she reiterated at formal hearing. This proceeding followed. 1/
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order ratifying the terms of the moratorium as modified by the April 15, 1996 letter; requiring the correction of the remaining deficiencies, including the re-training of Ms. McCorvey; and establishing a schedule for compliance and a procedure by which Ms. McCorvey can establish compliance. DONE AND ENTERED this 27th day of August, 1996, in Tallahassee, Florida. ELLA JANE P. DAVIS, 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.
The Issue This issues to be resolved in this proceeding concern whether the Petitioner's funding for skilled nursing services should continue to be provided in the manner and from funding sources presently operative, or whether there is a more cost- effective means of addressing his need for skilled nursing services; and whether there are sufficient funds for use by the developmental disability program for his skilled nursing services.
Findings Of Fact The parties essentially agree on all relevant facts involving the Petitioner's eligibility for, and receipt of, developmental disability program services. Neither party disputes that the Petitioner is currently eligible and is receiving services under the HCBS Waiver, because of the primary diagnosis of spina bifuda, and but for the current scarcity of HCBS Waiver (Medicaid Waiver) (Med Waiver) funding or fee- accepting skilled nursing service providers, this dispute would not exist. The Florida Medicaid Waiver program is a waiver by the federal government of regular Medicaid rules to service individuals in community-based settings as an alternative to institutional placement in intermediate care facilities for the developmentally disabled. The Legislature in the Appropriations Act for the 2001-2002 fiscal year passed "proviso language" which limited spending on the developmentally disabled recipients to spending provided by a "spending plan" enacted by the Department in which the districts of the Department are to provide services pursuant to an established set of priorities and prohibitions. The Department enacted a spending plan which states in pertinent part, "Effective immediately, all covered waiver services must be provided through waiver funding. The purchase of wavier billable services through the IFS budget category [general revenue] is no longer allowable unless the central office has approved an exception." Thus, funding for the HCBS Waiver is intended to be in accordance with the spending plan developed by the Department, which was required to be submitted to the Governor for approval by November 1, 2001. Pursuant to this plan, the Department prohibits the use of general revenue funds to pay for services provided with the HCBS Waiver program unless an exception is authorized by the central office of the Department. The Petitioner, Douglas Gunther, is a waiver program participant and has been since April 2000. He has been receiving skilled nursing services funded by the Med-Waiver program and funded partially through Individual and Family Support (IFS), a general revenue budget category, since April 2000. The Petitioner's skilled nursing services are covered "waiver services," all of which would be paid by the Med-Waiver program if provided by an approved, Med-Waiver provider (nurse), instead of a non-waiver provider (a nurse who has not entered into an agreement to accept the Med-Waiver fee schedule). A request for an exception to continue the funding of some skilled nursing services through general revenue IFS budget funds, was made by District 12, but was not granted by the Department's central program office. The District 12 Developmental Disabilities Office is prohibited by the state-wide spending plan from continuing the purchase of service, such as the Petitioner needs, with the general revenue IFS budget funds for all services normally covered by the Med-Waiver program, because of a directive to "maximize federal funding." See Department's Exhibit 2 in evidence. According to the Department, the funding of such skilled nursing services through the use of any general revenue IFS budget funds would require an exception to the spending plan provisions to be granted by the central program office of the Department which has not as yet been accomplished. No other source of funding, such as "spina bifuda fund" monies were shown to be currently available to fund skilled nursing services for the Petitioner other than the Med-Waiver funding program, or if the Petitioner was in an institutional facility (more expensive) then state Medicaid funds could be provided. Skilled nursing services are more costly when paid to a non-waiver provider than to a Med-Waiver nursing provider because a Med-Waiver provider must negotiate and agree to accept certain lower Medicaid rates in order to become a Med-Waiver provider, contract nurse. The Petitioner has a physician's prescription for skilled nursing to be provided from one to two hours per day. He is developmentally disabled because of his spina bifuda condition and arnold-chairi syndrome. He basically must use a wheel chair for all ambulation. He receives a bowel therapy program with digital stimulation, range of motion therapy, blood pressure monitoring, and his personal care needs, such as showering, dressing, and transfer. Occasionally he receives treatment for decubitus ulcers. The bowel program therapy requires the services of a skilled nurse. The Petitioner became eligible for the HCBS Waiver in May 2000. Shortly thereafter, the Department agreed to continue to pay his skilled nursing service with general revenue dollars because there were no HCBS Waiver nursing providers enrolled in the Daytona Beach area who could provide that service to him for the HCBS Waiver-approved rates. The Department allowed the Petitioner one year to transition his provision of nursing services to Med-Waiver services. He did not do that because such an HCBS Waiver provider could not be located in the Daytona Beach area. When the Petitioner failed to obtain skilled nursing services from a Med-Waiver provider, the Department sent him a notice to terminate the service of skilled nursing with general revenue funds on May 15, 2001, which engendered this dispute. The Petitioner was notified that his skilled nursing services funded by general revenue were to be terminated because "there was a more cost-effective means of addressing his nursing requirements and that there were insufficient funds with which to continue funding that service." See Exhibit 7 in evidence. The Department was aware at the time the termination notification was sent to the Petitioner that there were no HCBS Waiver skilled nursing providers available in the Daytona Beach area to care for the Petitioner's needs. Without skilled nursing services, the Petitioner would be required to be institutionalized, which is at a much higher cost in dollars, aside from the human cost involved. The Department currently has funding with which to pay for the skilled nursing care from its IFS funds, because it is paying for them currently, pending resolution of the subject dispute. The spending plan referenced above, while mandating that such not be provided from general revenue or IFS funds but rather through HCBS Waiver funding, allows for the central office of the Department to grant an exception to the prohibition on the current mode of payment. That is an alternative available which could keep the Petitioner from more costly institutionalization while the parties work diligently to attempt to locate and enroll, by contract, an appropriate nursing service provider or providers who will accept the fee reimbursement levels mandated by the HCBS Waiver program.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, and evidence of record, the pleadings and arguments of the parties, and the candor and demeanor of the witnesses, it is, therefore: RECOMMENDED that a final order be entered continuing the present mode of funding for the Petitioner's skilled nursing services for the immediate future by the granting of an exception to the spending plan mandate referenced above by the Department. It is further RECOMMENDED that both the Petitioner and the Department make strenuous efforts to collaborate and locate and enroll one or more appropriate skilled nursing service providers under the HCBS Waiver program within the next year from the date of the final order. DONE AND ENTERED this 7th day of January, 2002, in Tallahassee, Leon County, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 7th day of January, 2002. COPIES FURNISHED: Cathy McAllister, Esquire Department of Children and Family Services 210 North Palmetto Avenue Suite 412 Daytona Beach, Florida 32114 Gordon B. Scott, Esquire Advocacy Center for Persons with Disabilities, Inc. 2671 Executive Center Circle, West Tallahassee, Florida 32301-5092 Peggy Sanford, Agency Clerk Department of Children and Family Services 1317 Winewood Boulevard Building 2, Room 204B Tallahassee, Florida 32399-0700 Josie Tomayo, General Counsel Department of Children and Family Services 1317 Winewood Boulevard Building 2, Room 204 Tallahassee, Florida 32399-0700
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner be reimbursed for fiscal year 1979 and 1980 in accordance with the foregoing adjustments. DONE and ENTERED this 17th day of December, 1982, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1982.
