The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON 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 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 2017.
Findings Of Fact Upon consideration of the oral and documentary evidence presented at the hearing, the following relevant facts are found: At all times pertinent to the matters considered here, the Respondent was a medical doctor licensed by the State of Florida under license number ME1472. He has been engaged in the practice of medicine for 50 years. While in practice in Orlando, Florida, during the period March 14, 1980, through August 8, 1980, Respondent had as a patient, and acted as treating physician for, Mary Walsh, who was at the time suffering from cancer of the lung. Respondent's treatment of Mary Walsh during the entire period she was his patient included the administering to her of laetrile, dimethylsulfoxide (DMSO) intravenously, enzymes, and megavitamins. Dr. James M. Johnstone (D.O.) had been a physician to Mrs. Walsh over a period of several years for a variety of complaints. (Her lung cancer was detected in December, 1979, however, when she went into his office on a routine visit.) Over the period of time he had treated her, she had suffered from such things as seizures, thyroid problems, and the like, but on this particular December 1979 visit, she complained of a sore throat. Dr. Johnstone referred her for consultation with a Dr. Porth, who ultimately opined she might have cancer of the epiglottis. As a result, in January, 1980, she was admitted to the hospital, where she was diagnosed as having cancer of the left lung. Exploratory surgery conducted during a second period of hospitalization in February, 1980, revealed that the cancer was inoperable and terminal, and the procedure was terminated without any surgical excision. Dr. Johnstone and several other physicians advised Mrs. Walsh and her daughter, Vicki L. Chapman, that conventional-treatments such as radiation therapy were available for, if not a cure, at least palliative treatment to reduce pain and perhaps extend life somewhat, but Mrs. Walsh was afraid of radiation therapy and refused it repeatedly. During this period of diagnoses and tests, Mrs. Walsh and her daughter, Vicki, were told by an acquaintance named Elmer Boener, of the Fairfield Medical Center in Jamaica, which offered the organic approach to cancer control, including the use of diet and vitamins. While Mrs. Walsh and her daughter were deciding whether to go to Jamaica, Mr. Boener informed them that a Dr. Wedel would be working at Respondent's clinic offering the same treatment as available in Jamaica, and they would not have to have the stress of going out of the country. They decided to go to Jamaica, however, because of the stress in this course of treatment on diet and, in March, 1980, went to the Fairfield Clinic for ten days, returning during the first week in April, 1980, at which time Mrs. Walsh took up treatment of her condition with Dr. Wedel and Respondent at the latter's clinic in Orlando. Mrs. Chapman went with her mother on almost every visit to Respondent's office and was present when Mrs. Walsh talked with either doctor or got her treatment. On one occasion, after looking at some X rays taken of Mrs. Walsh's lungs, in the presence of Mrs. Chapman, Dr. Lynn allegedly told Mrs. Walsh that her cancer was shrinking and getting better. This was not true. Dr. Lynn denies telling her this, saying he told her the amount of fluid in the lungs had reduced, but not the size of the cancer. Considering all the evidence and weighing all the factors, I find that Dr. Lynn did make the statement alleged. However, Mrs. Walsh still had pain, and Respondent would not prescribe medication for her. Because of that, she had to go to another doctor for a prescription for whatever she needed to relieve pain. During the time that Respondent treated Mrs. Walsh, he was assisted by a "Dr." Wedel, who held himself out to be a nutritionist. However, search of the records of the various licensing agencies for the medical disciplines within this state reveals that he is not licensed as a medical doctor, osteopath, naturopath, physical therapist, podiatrist, chiropractor, pharmacist, registered nurse, or licensed practical nurse. His service to Mrs. Walsh consisted of nutritional counselling as to diet, vitamins, etc., and writing prescriptions for vitamins that were subsequently signed by Respondent. Respondent's supervision of Wedel was not regular, but periodic. Wedel was recommended to Respondent by a friend in Oregon and intended to apply for a Florida license as a medical doctor. Dr. Lynn states that before offering Wedel employment, he cleared taking him on with the Orange County Medical Association, which agency interposed no objection. When Mrs. Walsh returned to Respondent's care from Jamaica, she requested that he continue the course of treatment she had been undergoing there, which included diet control and the use of vitamins, enzymes, laetrile, and DMSO. Though Dr. Lynn's medical notes were not introduced at the hearing, he indicated that they fail to reveal he counseled Mrs. Walsh on other, conventional forms of treatment for her condition, such as X-ray therapy or chemotherapy. He is satisfied, however, that she was aware of them. Respondent, due to Mrs. Walsh's request to him that he continue the use of laetrile and DMSO, had her oral consent to do so. However, he did not have, nor did he insure that, his staff secure for him her informed, written consent to treat her with either drug. Further, he did not, prior to utilizing either drug, inform her in writing that neither was approved for use in the treatment of cancer by the Federal Food and Drug Administration of the United States Department of Health and Human Services (FDA). Laetrile, DMSO, enzymes, and megavitamins, either singly or taken together, are unconventional treatments for cancer, as accepted by the medical community, and are generally recognized by that community as being experimental.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent's license to practice medicine in the State of Florida be suspended for a period of one year. RECOMMENDED this 11th day of April, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 11th day of April, 10983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William Trickel, Jr., Esquire 35 West Pine Street Orlando, Florida 32801 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
The Issue The issues in this case are whether Respondent violated section 456.072(1)(bb), Florida Statutes (2008),1/ and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this case, Dr. Diaz-Ramirez was a licensed medical doctor within the State of Florida having been issued license number ME96703. Dr. Diaz-Ramirez is board certified by the American Board of Anesthesiology and Pain Management. At all times material to this case, Dr. Diaz-Ramirez was employed by Sarasota Memorial Hospital (SMH) Physician's Services Group, as a medical director of the pain management program. On October 7, 2008, C.C. presented to Dr. Diaz- Ramirez's office for evaluation for continued treatment of her long-standing back pain. Dr. Diaz-Ramirez examined C.C. and noted her assessment as chronic low back, right leg, and hip pain with severe right L2-3 foraminal stenosis, status post L3- S1 fusion, and lumbar postlaminectomy syndrome. There was no indication on October 7, 2008, that C.C. was having problems with her sacroiliac joint. Dr. Diaz-Ramirez discussed her treatment plan with C.C. and noted the following in C.C.'s medical records: Today we reviewed the actual CT scan films from 07/10/2006. We have also reviewed her laboratories from July. The pain is persistent. It seems to be spinal in origin. We have decided to perform bilateral L2-3 transforaminal epidural steroid injections for pain management of her symptoms. She will continue with current analgesics. She was instructed to take her oxycodone every six hours. We will be performing these injections twice and we will see her in follow-up 2-3 weeks after the injections. Dr. Diaz-Ramirez signed an order for bilateral L2-3 transforaminal epidural steroid injections to be done two times. This order was on a document entitled Discharge Instructions.2/ When the order for the first bilateral L2-3 transforaminal epidural steroid injections was put into the scheduling system for the Sarasota Memorial Health Care System Pain Management procedure area, the procedure was erroneously scheduled as a sacroiliac joint injection. Because of the scheduling error, all of the documentation for the procedure, including the physician order for the procedure and the consent form, was filled out for a sacroiliac joint injection. On October 15, 2008, C.C. presented for bilateral L2-3 transforaminal epidural steroid injections. Prior to performing the procedure, Dr. Diaz-Ramirez examined C.C. C.C. advised Dr. Diaz-Ramirez that her pain had increased and moved. However, the pre-operative history and physical notes hand written by Dr. Diaz-Ramirez at 8:35 a.m. on October 15, 2008, state that the history and physical remain unchanged from October 7, 2008, except for a sprain of C.C.'s left ankle. Prior to doing the procedure on October 15, 2008, Dr. Diaz-Ramirez talked with C.C. and explained to C.C. that a sacroiliac joint injection would be performed. It was Dr. Diaz- Ramirez's opinion that based on the examination and her discussion with C.C. that a sacroiliac joint injection was appropriate for C.C.'s pain on that day. C.C. signed a consent form for a sacroiliac joint injection. Dr. Diaz-Ramirez performed the sacroiliac joint injection on C.C. After the procedure, Dr. Diaz-Ramirez went back to her office to dictate her notes. For the first time that day, she looked at her original order and saw that on October 7, 2008, she had ordered bilateral L2-3 transforaminal epidural steroid injections for C.C. Realizing that there had been a scheduling error, she contacted Ronda Layton (Ms. Layton), the clinical coordinator for the pain management center. This was not the first time that a scheduling error had taken place, and Dr. Diaz-Ramirez reported the scheduling error to Ms. Layton so that the problem could be addressed. Dr. Diaz-Ramirez and Ms. Layton went to the bedside of C.C. and told her that a wrong procedure had been done. C.C. was advised that she had been scheduled for bilateral L2-3 transforaminal epidural steroid injections, but a sacroiliac joint injection had been performed. C.C. was also advised that Dr. Diaz-Ramirez felt that the sacroiliac joint injection was the appropriate procedure for the pain that C.C. was experiencing that day. After talking with C.C., Dr. Diaz-Ramirez dictated her report on October 15, 2008. She noted that her pre-operative diagnoses were "[l]eft low back pain, sacroiliac pain and lumbar spinal stenosis." This is the first time that Dr. Diaz-Ramirez specifically noted that C.C. was experiencing sacroiliac pain. Her notes further stated: The patient is a [redacted] year-old [redacted] patient with chronic low back pain with lumbar spinal stenosis scheduled for bilateral L2-L3 transforaminal epidural steroid injection. We performed sacroiliac joint steroid injection for management of her symptoms. On October 28, 2008, Dr. Diaz-Ramirez made an addendum to her report dated October 15, 2008. The addendum stated: After the procedure was done, it was discovered that the intended scheduled procedure was not performed. The patient was made immediately aware and full disclosure was made. Under the circumstances of the evaluation this morning, the sacroiliac joint injection would not have been an inappropriate procedure to perform for this patient and she actually received immediate relief in the area of her pain. The patient understood. She agrees and she will be seen for her intended scheduled procedure of a bilateral transforaminal epidural steroid injection at L2-L3 at her next visit. On October 15, 2008, C.C.'s pre-operative pain level on a scale of one to ten, with ten being the worst and one being the least, was ten. Her post-operative pain level was seven, and her pain level at discharge was between nine and ten. C.C. was scheduled for bilateral L2-3 transforaminal epidural steroid injections for October 22, 2008, and Dr. Diaz-Ramirez performed the scheduled injections on that date. C.C.'s pre-operative pain level on October 22, 2008, was seven. Her post-operative pain level was four, and her discharge pain level was between four and five.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Diaz-Ramirez did not violate section 456.072(1)(bb) and dismissing the Administrative Complaint. DONE AND ENTERED this 16th day of February, 2011, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of February, 2011.
The Issue Whether the Respondent committed the violations alleged in the administrative complaints; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine pursuant to Florida law. The Respondent is a licensed physician in the State of Florida having been issued license number ME 0043628. In September, 1987, J.B., a patient at Hialeah Hospital, underwent exploratory surgery and was diagnosed with terminal pancreatic cancer. At the time of the surgery, it was estimated that J.B. had six months to live. Dr. Roberto Cruz, J.B.'s doctor at Hialeah Hospital, recommended that the patient undergo chemotherapy; however, J.B.'s wife rejected that proposal. She did not want J.B. to know of the diagnosis. J.B. had told his family that if he had cancer, he would commit suicide. J.B.'s father and brother had had cancer, and the latter had committed suicide. J.B.'s wife and sister believed his threat to be sincere. Based upon the foregoing, J.B.'s wife implored J.B.'s doctors not to disclose his true condition. The families of J.B. and Respondent had been friends for many years going back to their common home in Central America. Respondent knew of J.B.'s diagnosis, and agreed to become his treating physician in November, 1987. Respondent did not tell J.B. of his true medical condition. Instead, Respondent let J.B. presume discomfort and other symptoms were the result of years of heavy drinking. In November, 1987, Respondent had been in private practice only a short time and was unfamiliar with office practices and billing procedures. Respondent did nothing to become familiar with billing practices, and relied on an employee who he mistakenly believed was competent to complete billing from the patient charts. When J.B. first presented at Respondent's office, he complained of abdominal pain. Further J.B. had discovered lumps which concerned him. To pacify J.B., Respondent suggested that a lymph node be removed and biopsied. J.B. and his wife discussed the removal of the lump and agreed that such removal would be appropriate. J.B. wanted to know that the lump was not cancer, and his wife wanted to know that the cancer had not spread or metastasized beyond the original sites. Respondent performed the lump removal in November, 1987, and billed J.B.'s medical insurance for same. At the time of this surgery Respondent was fully aware of J.B.'s medical condition, and knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. The only medical result of the procedure was the uplifting of J.B.'s mental attitude since the lump was not cancer. In March, 1988, Respondent performed a colonoscopy with biopsy on J.B. This procedure was suggested as Respondent had presented with rectal bleeding, a symptom common in terminal cancer patients, and was desirous of some diagnosis as to the medical origin of the bleeding. Instead of advising J.B. that the bleeding could be consistent with the known medical condition, Respondent went ahead with the colonoscopy after less intrusive examinations did not establish the origin of the blood. At the time of the colonoscopy, Respondent knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. Again, the only beneficial effect from the colonoscopy was an uplifting of J.B.'s mental attitude since the colonoscopy results, which were medically inconclusive, did not disclose cancer to J.B. Even if the colonoscopy had revealed some medical condition which could be treated, it would not have been medically necessary given J.B.'s other, overriding, condition. Anemia, a condition resulting from the loss of blood which is common in terminal cancer patients, could be treated without the colonoscopy procedure. Respondent did not refer J.B. to a psychiatrist for mental evaluation or confirmation as to the suicidal ideation but accepted J.B.'s wife's representations regarding his mental state. Respondent did not allege J.B. had expressed suicidal thoughts to him and did not report same in his medical notes. At all times material to the treatment of J.B., Respondent performed medical services through a company owned by his wife. This company, Sigma Medical Center, submitted bills for the services afforded J.B. on the standard billing forms known as "HCFA 1500." Respondent, as the treating physician, was required to sign all HCFA 1500 forms submitted regarding services for J.B. By executing the HCFA 1500 form Respondent certified that the information was correct and the procedures billed for were medically necessary and appropriate. In this case, Respondent has admitted that numerous billing errors occurred, that the HCFA 1500 forms were incorrect, and that an over-billing regarding services provided to J.B. resulted. For example, consultation visits are billed at a higher rate than regular office visits. Respondent routinely billed J.B.'s visits at the consultation rate even though there was no consultation to be given. Second, Respondent billed post-operative visits which should have been included in the surgical charges separately. Third, J.B. returned for office visits more frequently than would be expected because of the pain management Respondent employed. Because J.B.'s wife would not allow Respondent to prescribe any pain medications which J.B. might associate with cancer, he ended up taking quantities of other prescriptions to manage the pain and to return to Respondent frequently due to the unexplained (to him) reoccurrence of pain. Despite an admission that he reviewed the HCFA 1500 forms before signing them, Respondent maintains he did not, at the time, know that the billing was inaccurate. This assertion has not been deemed credible As to various tests ordered by Respondent for J.B., it is concluded that the following tests were medically unnecessary: the RPR test designed to detect syphilis infection (a STD was the least of this patient's worries), the FTA (a follow-up test to the RPR), and thyroid studies. Given the totality of the circumstances, Respondent's care and treatment of the patient, J.B., fell below the standard of care and skill which a reasonably prudent physician under similar circumstances and conditions would recognize as acceptable. As to DOAH case no. 94-0778 L.G. was an employee in Respondent's office. Unbeknown to Respondent, L.G. took samples of aerobid and proventil without a prescription for the drugs. An aerobid inhaler is used to control the symptoms of bronchial asthma. Proventil is also used to control bronchospasm which may be associated with asthma. L.G. took the samples with the intent that she would forward them to a relative in Cuba who suffers from asthma. L.G. had access to the samples. Respondent had never treated L.G. and there would have been no medical justification to dispense the samples to her. Although somewhat incredulous, Respondent's admission that he had dispensed the samples to L.G. was given, to his understanding, to end the investigation of the matter. He mistakenly believed that if he made the admission the matter would be closed. L.G.'s account as to the events of her removing the samples without Respondent's knowledge has been accepted. Nevertheless, the statement Respondent gave to the Department in connection with this incident was false.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Agency for Health Care Administration, Board of Medicine, enter a final order determining the Respondent violated Sections 458.331(1), (n) and (t), Florida Statutes, in the care provided to patient, J.B., suspending his license for a period of one year, placing him on probation for a period of two years thereafter, and imposing an administrative fine in the amount $10,000. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 24th day of December, 1996. JOYOUS D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of December, 1996. APPENDIX Rulings on the proposed findings of fact submitted by the Petitioner: Paragraphs 1 through 17, 19 through 39, 42 through 46, 48 through 52, 54 through 65, 69, 70, and 74 are accepted. Paragraph 18 would be rejected as contrary to the weight of the credible evidence IF J.B. had been sincerely suicidal; however, in this case Respondent did not refer J.B. to a psychiatrist, did not make an independent confirmation of J.B.'s mental state, and did nothing to which J.B.'s wife did not agree--therefore, it is impossible under the facts of this case to know whether or not J.B. should have been told. Under most circumstances, J.B. should have been told, and it is accepted that the care afforded to J.B. fell below the standard of care a reasonably prudent similar physician would have provided. Respondent's whole theory of this matter fails because Respondent never independently confirmed and had J.B. properly assessed, by a physician competent to make such assessment, as to whether this major hoax was appropriate. With all due respect to Dr. Blaustein, he merely relied on factual conclusions which are unsupported by medical records in this case. Paragraphs 40 and 41 are rejected as irrelevant because the examination was medically unnecessary regardless of how performed. Paragraph 47 is rejected as contrary to the weight of the credible evidence; this procedure, like others, was medically unnecessary and below the standard of care but its primary purpose was to pacify the patient and his wife regarding the rectal bleeding. Had Respondent been forthright this procedure would not have been performed. The overbilling for the procedure was for financial exploitation of the patient's insurance. Paragraph 53 is rejected as irrelevant because the studies were medically unnecessary anyway. Paragraphs 66 through 68 are rejected as irrelevant since the diagnosis would have always been subservient to the primary diagnosis and Respondent's services in this regard were medically unnecessary. Paragraph 71 is rejected as contrary to the weight of the evidence. L.G. was not Respondent's patient. L.G. stole the drugs and Respondent covered for her with the misguided idea that it would solve the problem and the investigation would be over. Paragraphs 72, 73, 75, 77, and 78 are all rejected since L.G. was not a patient they are irrelevant or contrary to the weight of the credible evidence. Rulings on the proposed findings of fact submitted by the Respondent: 1. Paragraphs 1 through 6, 8, 10, 11, 12, 18, 19, 22, 23, 24, 31, 32, 38 through 48, 51, 55 through 64, 68 through 74, 77, 81, 82, 84, 85, 86, 89 through 92, 100, 107 through 120, 122, and 123 are accepted. Paragraph 7 is rejected as speculation or irrelevant given the overriding issues of this case; further rejected as not credible. Paragraph 9 is rejected in part as contrary to the weight of the credible evidence as to the issue of money; otherwise, as to the families' long- standing friendship accepted. The credible evidence in this case supports the conclusion that Respondent was overpaid for unnecessary services until J.B.'s insurance ran out; that he did not require payment thereafter is irrelevant. It may also have been Respondent's motive for overcharging the insurance before it ran out. Paragraphs 13 through 17 are rejected as irrelevant or contrary to the weight of credible evidence. Respondent was not authorized to delegate the medical decisions regarding J.B.'s care to his wife or family. As the physician he was responsible, regardless of how difficult the situation, to either practice within the standard the care or refer the patient to a physician able to do so. Obviously, any physician would want to keep J.B. comfortable, that is why unpleasant procedures such as the colonoscopic examination were, in part, medically unnecessary. Respondent's highest obligation was to the patient not that person's family or their perceived (and uncorroborated by Respondent) notions as to the patient's mental state. Paragraph 20 is rejected as irrelevant. Paragraph 21 is rejected as contrary to the weight of credible evidence. Paragraphs 25 through 30 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraph 33 is rejected as contrary to the weight of credible evidence. Paragraphs 34 through 37 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 49, 50, 52, 53, and 54 are rejected as irrelevant or contrary to the weight of the credible evidence. The fact that J.B. was encouraged by the false or meaningless services performed by Respondent does not justify the performance or billing for same. Respondent could have listed a textbook full of conditions which J.B. did not have to encourage him but it would not have been based on medical reality any more than the colonoscopy was. Lying to a patient to make him fell better and for financial gain is not acceptable practice. Paragraphs 65, 66, and 67 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 75, 76, 78, 79, and 80 are rejected as irrelevant or contrary to the weight of the credible evidence. 13. Paragraphs 83, 87, 88, 93, 94, 95, 96, 97, 98, 99, 101, 102, 103, 104, and 105 are rejected as irrelevant or contrary to the weight of the credible evidence. Respondent was responsible for all insurance billing for Sigma Medical Center. Paragraph 106 is rejected as contrary to the weight of the evidence as to whether or not L.G. was a patient at the time of the incident complained of, or irrelevant if stating such relationship was at a prior time. Paragraph 121 is rejected as irrelevant. Paragraph 124 is rejected as contrary to the weight of credible evidence. COPIES FURNISHED: Hugh R. Brown Senior Attorney Agency for Health Care Administration Office of the General Counsel Post Office Box 14229 Tallahassee, Florida 32317-4229 Harold M. Braxton, Esquire Suite 400, One Datran Center 9100 South Dadeland Boulevard Miami, Florida 33156-7815 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the Petitioner committed the violations alleged in the Administrative Complaint, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health is the state agency responsible for certifying and regulating basic X-ray machine operators in Florida. Sections 468.3001-.312, Florida Statutes. On March 30, 1993, Paul Butler was issued Basic X-ray Machine Operator Certificate Number 7729. The certificate expired December 31, 1994, and Mr. Butler requested renewal by submitting a renewal form and the required fee to the Department on December 20, 1996. Mr. Butler admitted that he knew his certificate expired December 31, 1994, but that he nonetheless took numerous X-rays subsequent to that date. On January 4, 1996, Mr. Butler prepared and submitted an application for employment to Kristie Green, office manager for South Dade Orthopedic Associates. In that application, Mr. Butler signed his name and appended to his name the designation "RMA, CRT." Ms. Green interviewed Mr. Butler, and he provided her with a copy of his certificate that showed an expiration date of December 31, 1995. Ms. Green noted that his certificate had expired four days previously, and Mr. Butler told her he was short of funds and would send in his renewal application when he received his first paycheck. Ms. Green hired Mr. Butler as an X- ray technician and medical assistant. After Mr. Butler repeatedly assured her that he had sent his renewal application to the Department, Ms. Green fired Mr. Butler on June 20, 1996, because he had not obtained a current Basic X-ray Machine Operator certificate. The evidence presented by the Department is sufficient to establish that Mr. Butler took X-rays without having an active certificate, and that he identified himself in his employment application to South Dade Orthopedic Associates as a Certified Radiologic Technologist by using the letters "CRT" after his signature. The evidence presented is also sufficient to permit the inference that Mr. Butler altered his basic X-ray Machine Operator certificate by changing the expiration date from December 31, 1994, to December 31, 1995.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health issue a final order finding that Paul Butler violated Section 468.3101(h), Florida Statutes, by violating Section 468.302(1) and (2) and that he violated Section 468.3101(f). Based on the violations, the Department of Health should impose the following penalties: Suspend Mr. Butler's Basic X-ray Machine Operator certificate for a period of six (6) months; Impose an administrative fine in the amount of Six hundred twenty-five dollars ($625.00); and Condition the reinstatement of Mr. Butler's certificate on his having completed thirty (30) hours of continuing education. DONE AND ENTERED this 12th day of January, 1998, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 12th day of January, 1998. COPIES FURNISHED: Morton Laitner, Esquire Department of Health 401 Northwest 2nd Avenue Suite N-1014 Miami, Florida 33128 Paul Butler, pro se 30525 Southwest 149th Court Leisure City, Florida 33033 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Pete Peterson, General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700
The Issue Two issues are raised in this case. The first issue concerns the question of whether the Petitioner must seek review and permission by and from the Respondent before engaging in this project to provide inpatient radiation therapy. See Section 381.706(1)(h), Florida Statutes. If that question is answered in the affirmative, then the next question to be answered is whether Petitioner is entitled to a certificate of need to provide inpatient radiation therapy services at its hospital in Pensacola, Florida. In answering the initial question reference is made to the case of Scared Heart Hospital of Pensacola v. Department of Health and Rehabilitative Services, and Baptist Hospital, DOAH Case No. 90-3576. That reference is made because Intervenor in the present case has made a motion in limine which asserts that the Petitioner here is estopped from raising the issue of whether jurisdiction resides with the Respondent to require a certificate of need based upon the belief that DOAH Case No. 90-3576 has answered that question in the affirmative. Thus, as argued in the motion in limine, Petitioner in the present action should be barred by doctrines of collateral estoppel and res judicata from further examining that issue. Both issues are addressed in the fact finding and conclusions of law which follow, to include a ruling on the motion in limine. At the commencement of the hearing in discussing the motion in limine an examination was made of the significance, if any, of the Petitioner having failed to clearly state its opposition to the Respondent's assertion of jurisdiction over the subject matter and that party in the Petition contesting the decision on the merits to deny the application for certificate of need. Consequently, the issue of whether Petitioner has waived its right to contest the jurisdiction is also addressed in the Recommended Order.
Findings Of Fact MOTION IN LIMINE (DOAH Case No. 92-3576) On the prior occasion described in DOAH Case No. 90-3576, Petitioner had applied to Respondent for a certificate of need to institute radiation therapy services and to construct a radiation therapy facility at the campus of its hospital in Pensacola, Florida. That center was to serve inpatients and outpatients. The projected capital expenditure for that project approximated 3.7 million dollars. Petitioner contended that the radiation therapy center that would be constructed would be an extension to an existing oncology program as contrasted with the establishment of a "new service." Consistent with that position Respondent asserted that the basis for requiring a certificate of need was found in the language at Section 381.706(1)(c), Florida Statutes, which states: A capital expenditure of $1 million or more by or on behalf of a health care facility or hospice for a purpose directly related to the furnishing of health services at such facility; provided that a certificate of need shall not be required for an expenditure to provide an outpatient health service, or to acquire equipment or refinance debt, for which a certificate of need is not otherwise required pursuant to this subsection. The department shall, by rule, adjust the capital expenditure threshold annually using an appropriate inflation index. By resort to Section 381.706(1)(c), Florida Statutes, as the basis for declaring jurisdiction, the Respondent in its preliminary position did not perceive that the proposed project constituted establishment of new institutional health services or a substantial change to the existing health services, rather, it was believed to be constituted of construction costs as a capital expenditure related to the existing oncology program which expenditure met the $1 million threshold. If the basis for jurisdiction was found within Section 381.706(1)(c), Florida Statutes, then the would-be intervenor in that case, the same intervenor here, would be denied intervention. The basis for denial is found within the limitations placed upon those persons who may participate in a decision involving certificate of need for a capital expenditure as identified in Section 381.706(1)(c), Florida Statutes. That contest is between the Respondent and an applicant for the certificate. Third parties have no right to participate. On the other hand, if the basis for jurisdiction is as argued by the petition for intervention in the prior case, that basis being the jurisdiction established by Section 381.706(1)(h), Florida Statutes, then a third party health care provider in competition with the applicant seeking a certificate of need could participate in that decision. The language in Section 381.706(1)(h), states: The establishment of inpatient institutional health services by a health care facility, or a substantial change in such services, or the obligation of capital expenditures for the offering of, or a substantial change in, any such services which entails a capital expenditure in any amount, or an annual operating cost of $500,000 or more. The department shall, by rule, adjust the annual operating cost threshold annually using an appropriate inflation index. The Hearing Officer in DOAH Case No. 90-3576, heard the matter and entered his Recommended Order to resolve the right of the present intervenor to intervene in that cause. In doing so the Hearing Officer generally addressed the jurisdictional basis upon which the agency could review the application. Nothing in that process attempted to distinguish between inpatient and outpatient costs by way of a discrete analysis and allocation of those costs. Observations were made in passing concerning the aggregate amount of inpatient and outpatient costs. In particular reference was made to the capital expenditure of approximating 3.7 million dollars. No attention was given the issue of the threshold amount associated with annual operating costs identified in Section 381.706(1)(h), Florida Statutes. Factual reference to that jurisdictional amount associated with annual operating costs was left for some other occasion. The thrust in DOAH Case No. 90-3576 was to determine whether the appropriate basis for the jurisdictional claim would be found in Section 381.706(1)(c), Florida Statutes, as initially contended by the Respondent or upon resort to Section 381.706(1)(h), Florida Statutes, as contended by the petition for intervention, without a more complete analysis concerning the jurisdictional amount set out in Section 381.706(1)(h), Florida Statutes, should the hearing officer be persuaded that the latter provision constituted the grounds for review generally stated. In the factual and legal conclusions by the hearing officer in DOAH Case No. 90-3576, he determined that the project in question for inpatient and outpatient radiation therapy services constituted the establishment of new inpatient institutional health services or at least constituted a substantial change in the services that were being provided by the applicant. Thus the petition for intervention was deemed appropriate and the motion to dismiss that petition was recommended for denial. Through the Final Order which followed, with some minor modifications which have no influence on the present case, the Respondent adopted the findings of fact of the hearing officer in DOAH Case No. 90-3576, and granted the petition to intervene. The Recommended Order was entered on April 3, 1991, and the Final Order on May 21, 1991. The parties in DOAH Case No. 90-3576 did not proceed to hearing before the present case was heard. The decision by the hearing officer in DOAH Case No. 90-3576 was to defer consideration of the matter pending hearing in the present case. That choice was upon a request by all parties in DOAH Case No. 90-3576. PARTIES STIPULATIONS CONCERNING REVIEW CRITERIA The parties agree that Petitioner's Certificate of Need Application No. 6772, the present application, meets the following statutory criteria: Section 381.705(1)(c), (h), except for the third clause which is not applicable and the fourth clause which is at issue, (i), (m), except that Intervenor contends that the project costs were not properly allocated to Petitioner's Certificate of Need Application No. 6772, and (n) to Section 381.705(1). The parties also agree that the following statutory criteria are not applicable to Petitioner's application: Section 381.705(1)(e), (f), (g) and (j), Florida Statutes. Within the context of the stipulation as to criteria, the parties agree that the following issues are to be litigated: The need for the proposed project in relation to the applicable district plan and state health plan. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the service district. The availability of and adequacy of other health care facilities and services in the service district, which may serve as alternatives for the services proposed to be provided by Scared Heart Hospital. The impact of the proposed project on the cost of providing health services proposed by Scared Heart Hospital. Whether less costly, more efficient, or more appropriate alternatives to the proposed services are available. Whether existing inpatient facilities, providing inpatient services similar to those proposed are being used in an appropriate and efficient manner. Whether patients will experience serious problems in obtaining inpatient care of the type proposed, in the absence of the proposed new service. The need that the population served or to be served has for the health services proposed to be offered, and the extent to which residents in the district are likely to have access to those services. The contribution of the proposed service in meeting the health needs of members of such medically underserved groups. BACKGROUND FACTS On August 22, 1991, Petitioner gave notice that it intended to apply for the September 19, 1991, batch review cycle to initiate inpatient radiation therapy services at its Pensacola, Florida facility. That notification referred to the fact that the Petitioner was presently constructing an outpatient cancer center to provide radiation therapy services and that the anticipated opening date for that outpatient facility was December, 1991. Petitioner did apply for the September 19, 1991 batch review for initiation of inpatient radiation therapy services. At that time the construction of the outpatient radiation therapy services was proceeding. Petitioner had received a letter of non-reviewability for the construction of the outpatient cancer treatment facility on a prior date. The completion of the outpatient radiation therapy services center at the Petitioner's facility was completed and Petitioner began to provide outpatient radiation treatment in April, 1992. The cancer treatment program at Petitioner's facility is a comprehensive cancer center providing radiation therapy, chemotherapy, IV. hydration, blood transfusion, nutrition counseling, social work counseling and a library. The outpatient facility for radiation therapy is fully staffed and supplied. It was placed on the books of the Petitioner as an active asset in the year 1991. Before submitting the application for review in September, 1991 review cycle, Petitioner conferred with Respondent and was instructed to submit an application for the initiation of inpatient services and to allocate costs to the project based upon a percentage of the total facility which would be devoted to inpatient services. Through the application Petitioner noted that the total cost of the establishment of the radiation therapy services projected to open in December, 1991, was $4,124,475. Pursuant to the instruction by the Respondent $618,671 was allocated as an estimate of capital expenditures for inpatient radiation therapy services. This approximates 15 percent of patients being treated as inpatients of the total number of patients treated by radiation therapy. Generally stated, the experience of most providers is that 10 to 15 percent of radiation therapy is delivered on an inpatient basis with the balance of the radiation therapy being delivered on an outpatient basis. The allocation of capital expenditures to inpatient therapy was an artificial device mandated by the Respondent. It does not reflect the actual experience. In actuality the incremental project costs related to capital expenditures for the inpatients receiving radiation therapy are zero. The reason for this finding is based upon the fact that the equipment for providing the inpatient radiation therapy is already in place, the facility for providing that care had been constructed, there is no associated incremental depreciation for inpatient care, the project has been fully paid for from funded depreciation cash and has been placed upon the books of the facility at 100 percent of that total. In essence, the capital costs have been incurred before the advent of the inpatient radiation therapy services. Additional costs promoted by the provision of care for inpatients who receive radiation therapy at the facility would be supply expenses attributable to those inpatients and the possibility of additional salaries attributable to overtime work done by staff to serve the inpatients. These are minimal costs. Operating costs were also artificially allocated to inpatients in the application. For the first year of operation, salaries allocated to inpatient care were estimated at $64,950.00, with associated benefits at $9,898.00, other patient care expenses at $17,925.00 and depreciation in the amount of $51,135.00. Even when resort is made to this certificate the proposal to institute inpatient radiation therapy does not reach the $500,000.00 threshold in annual operating costs, in addition to having no fiscal impact by way of capital expenditures. Petitioner is a 391 bed acute general hospital located in Pensacola, Florida. The services that it provides are available to inpatients and outpatients. Among those services are an open heart facility, neonatal intensive care Level II and Level III units, and freestanding 50 bed children's hospital. The patients receiving care for cancer are provided screening programs, risk assessments, preventative education programs, diagnostic services, surgery, chemotherapy and radiation therapy on an outpatient basis. The application for inpatient radiation therapy was not favorably reviewed in the State Agency Action Report issued on or about January 8, 1992. This led to the present hearing when Petitioner contested the decision to deny the application. Intervenor and West Florida Hospital, both of Pensacola, Florida, and the same planning district where Petitioner is located, have certificates of need to provide inpatient radiation therapy. They also provide outpatient radiation therapy. The other two hospitals treat patients referred by Petitioner for radiation therapy needs. The inpatients of the Petitioner requiring radiation therapy must be transported to the other two hospitals to receive that care. The majority of those patients who are being transported are referred to the Intervenor. Pediatric cancer patients from Petitioner's facility are transported to West Florida. The patients who are transported from Petitioner's facility to the Intervenor's facility are received by the Intervenor as outpatients. When they return to the Petitioner's facility they are perceived as inpatients. Each of the other two facilities who offer radiation therapy pursuant to certificates of need have two linear accelerators to provide inpatient and outpatient radiation therapy. Petitioner seeks to have its single linear accelerator which now provides outpatient radiation therapy made available to provide inpatient radiation therapy. There are also two non-hospital based radiation therapy centers which have single linear accelerators to provide outpatient radiation therapy services. Those non-hospital based providers are located in Ft. Walton Beach and Crestview, Florida, within the same planning district that is associated with this application. REVIEW CRITERIA 1/ Section 381.705(1)(a), Florida Statutes, requires that an application be reviewed for its consistency with the state and district health plans. Neither of those plans addresses the provision of radiation therapy services. As a consequence, neither plan sets forth need allocation factors that would address this type application. In view of the silence of the state and local health plans concerning inpatient radiation therapy, the application cannot be seen as inconsistent with those plans. Section 381.705(1)(b), Florida Statutes, speaks in terms of the availability, quality of care, efficiency, appropriateness, accessibility, and extent of utilization and adequacy of like and existing health care services in the service district to be served by the applicant. As stated before inpatient radiation therapy is being delivered by two other providers. Those providers make available and could continue to make availability the quality of care, which is efficient, appropriate, accessible and adequate in delivering inpatient radiation therapy to those patients which Petitioner would serve if granted the certificate of need to do so. The inpatient radiation therapy services offered by those two providers are not over-utilized at present nor would they be in the foreseeable future. The exception to these findings would be related to a quality of care issue not pertaining to the actual delivery of radiation therapy to patients referred from the Petitioner to the other two providers but related to the inconvenience in preparing those patients for transport for delivery of therapy and the transport itself. For some patients who are required to undergo the preparation for transport and transport, that process can be quite painful. Patients have refused to be transported to receive radiation therapy and this has complicated their treatment. It would be a less uncomfortable process if the patients were undergoing the radiation therapy at the Petitioner's facility. Physician's practice patterns in this community where some physicians choose to practice in a single hospital notwithstanding their admission privileges in multiple hospitals complicates the issue in that a patient may be admitted to Petitioner's facility because the admitting physician chooses to practice there alone. Once a diagnosis is made and a decision reached that the patient in that hospital needs to undergo radiation therapy, the need to transport for those treatment ensues. Moreover, as suggested, the decision to utilize radiation therapy in the treatment is not ordinarily made at the initial moment of admission when health care professionals are trying to make the initial diagnosis concerning the patients complaints in deciding whether they are associated with cancer or not and if radiation therapy would benefit the patient or even in the instance where the patient is known to have a history of that illness whether radiation therapy is indicated. Therefore, there might not be a reason to try and place the patient in a facility that has inpatient radiation therapy available if that treatment regime upon evaluation does not seem indicated. The issue concerning the ability to transfer a patient from one facility to another for the overall hospitalization to include provision of inpatient radiation therapy such that a patient who has been determined to need radiation therapy could be transferred from Petitioner's facility to Intervenor's facility for overall care, while theoretically possible does not seem practicable. Additionally, the patients who receive outpatient radiation therapy through Petitioner's facility who would need at some future point in treating the condition to be transferred to another facility to receive radiation therapy once admitted as an inpatient in Petitioner's facility breaks the continuity of the management of the care by requiring the patient to undergo an evaluation by two different radiation therapists, disrupting the patient- physician relationship in a setting which is complicated by the patient's condition. Nonetheless, the quality of care is not so compromised by the need to transport for the inpatients at the Petitioner's facility to receive radiation therapy to conclude that it constitutes a reason standing alone to grant the certificate of need. In a similar vein, as contemplated by Section 381.705(1)(d), Florida Statutes, the availability and adequacy of other health care facilities and services and hospices in the service district of the applicant, such as outpatient care and home care services, which might serve as alternatives for the applicant's proposal have been considered. Out of that list, only the possibility of the use of outpatient care provided by the existing facilities who offer outpatient radiation therapy would arguably have pertinence to this inquiry. They would not constitute an available and adequate substitute for inpatient radiation therapy for reason that patients who are admitted to a hospital are distinguished from those who come to the facility from other places for purposes of receiving outpatient radiation therapy. That distinction has to do with the gravity of the condition of the patient which caused the patient to be admitted to the hospital in the first instance, and to receive, together with medical attention and other therapies, the provision of radiation therapy. Concerning that portion of Section 381.705(1)(h), Florida Statutes, which describes the applicant's need to address the availability of alternative uses of resources for the provision of other health services, that clause was referred to as an issue in the prehearing stipulation but was not advanced at the hearing. Through the prehearing stipulation the parties did not include reference to Section 381.705(1)(k), Florida Statutes, as a provision about which there was an agreement concerning compliance or the need to comply with its terms. The record reveals that the applicant and the existing providers address the need for radiation therapy of individuals who are not residing in the service district. This project does not appear to have a pronounced influence in improving or diminishing health care for persons not residing in the service district. Section 381.705(1)(l), Florida Statutes, addresses the probable impact of the project on the cost of providing health services proposed by the applicant and it takes into consideration the effects of competition on the supply of health services being proposed and any improvements or innovations in the financing and delivery of health services which foster competition and serve as a promotion of quality assurance and cost effectiveness. Whether the applicant delivers services to the inpatients that it would gain with recognition of its application or some other entity serves the needs of those patients, the basic costs of providing health services would be relatively the same. The exception is the improvement in the circumstance of health care costs related to the transport of the patients from the Petitioner's facility to the two other facilities for provision of the radiation therapy of inpatients in the Petitioner's facility and the attendant costs of duplication of patient charges and professional fees charged by the physician therapist potentially associated with having a patient move from the status of an outpatient at the Petitioner's facility to an admitted patient at that facility who receives radiation therapy at one of the other two facilities while undergoing inpatient care in the Petitioner's facility. These additional costs in transport and potential for patient charges associated with procedures in the other two hospitals and physicians fees in those other two hospitals which are duplicative of efforts made by the Petitioner's outpatient radiation program in its procedures and the physician's fees associated with those outpatient radiation therapy procedures could be done away with if the project were approved. There is no indication of any significant improvements or innovations in the financing and delivery of health services associated with this application which might foster competition and serve to promote quality assurance and cost effectiveness. The cost improvements that are discussed here standing alone do not justify the applicant being granted a certificate of need. The advent of an inpatient radiation therapy service will not be so adverse in its impact that it will cause the Intervenor or any other existing facility to lose financial viability concerning the ability to maintain an appropriate level of utilization of existing facilities. There are no costs of construction and the method of proposed construction need not be considered in that the construction has been concluded as previously discussed. Consequently, the necessity to address the costs and methods of the proposed constructions as described in Section 381.705(1)(m), Florida Statutes, is not relevant to the inquiry. Nor are the references within Section 381.705(2), Florida Statutes, having to do with capital expenditures pertinent to the outcome in examining the review criteria. LACK OF A VIABLE NEEDS FORMULA Respondent does not have a rule which calculates the need for inpatient radiation therapy by resort to a formula which derives need. Neither does the Respondent have an emergent policy which it is developing to formulate the amount of inpatient radiation therapy services needed in a given review cycle. Respondent and the private litigants have attempted to examine the need for inpatient radiation therapy contemplated by this application by devising various mathematical formulas to determine need. Each explanation is fundamentally flawed in that they fail to address the discrete issue contemplated for examination by the review process, that is the need for inpatient radiation therapy. Instead, these methods look at all radiation therapy both inpatient and outpatient. The statute does not contemplate that form of evaluation. It is the 10 to 15 percent of all radiation therapy patients that constitute the inpatients. It is the provision of care to those persons that is subject to examination. If need is to be derived by use of a formula, a knowledge of the circumstances existing for outpatients, a category of patient for whom no certificate of need must be obtained to serve them, should not enter in to the analysis. The formulas exercised by the parties in measuring the overall need for inpatient and outpatient radiation therapy services derive the answers by identifying the number of linear accelerators needed in the district or in one instance for the applicant's facility alone. In that exercise a count is made of the four linear accelerators in the district belonging to the two hospitals which have been granted certificates of need which would allow inpatient radiation therapy to be delivered as well as outpatient therapy and the three programs that serve outpatients on three additional linear accelerators. The total number of linear accelerators is seven counting the linear accelerator the Petitioner has to serve outpatients. No attempt by formula has been made to ascertain whether more than four linear accelerators found within the two hospitals who have certificates of need to provide inpatient radiation therapy service are warranted. Thought provoking questions have been raised by the several parties in critiquing the needs calculation made by an opponent or opponents. However, it is not necessary to choose among these competing theories because in selecting any theory one cannot derive the amount of inpatient radiation therapy services needed in the district. Furthermore, case law does not allow the trier of fact to utilize the basic information provided by the parties to construct a formula for determining need for inpatient radiation services independent of the efforts of the parties in the person of their experts whom they have consulted with on this subject. This means that the decision here must be made by a review of applicable criteria without resort to a preliminary determination of numeric needs. This has been done. On balance, when taking into account the combination of improvements to quality of care for a patient being transported from the Petitioner's facility to receive radiation therapy and the improvement concerning the removal of the cost of that transport and duplication of charges and fees for certain patients who move from an outpatient posture under treatment by the Petitioner and into an inpatient status with Petitioner receiving radiation therapy at one of the two other hospitals which has been discussed in preceding paragraphs, the project is justified and the application should be granted.
Recommendation Based upon the consideration of the facts, and in view of the conclusions of law, it is, RECOMMENDED: That a Final Order be entered which declines jurisdiction to require a certificate of need for inpatient radiation therapy services or in the alternative grants a certificate of need for inpatient radiation therapy services. DONE and ENTERED this 20th day of August, 1992, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of August, 1992.
