The Issue At issue in this proceeding is whether Respondent committed the offense set forth in the Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact The parties The Department of Health, Division of Medical Quality Assurance, Board of Medicine (Department), is a state agency charged with the duty and responsibility for regulating the practice of medicine pursuant to Section 20.43 and Chapters 455 and 458, Florida Statutes. Respondent, Manuel Ortega-Elias, is, and was at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0061620. Respondent is board-certified in pediatrics and neonatology. Patient A. T. Patient A. T. (hereinafter A. T. or Ashley) was the product of a twin pregnancy and born prematurely (at 31 weeks gestation) at Plantation General Hospital on December 19, 1993. Delivery was by cesarean section (due in part to breach presentation) and on delivery A. T. was assigned Apgar scores of 1, 7, and 8, at one, two, and five minutes, respectively. The Apgar scores assigned to A. T. are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritability, and color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute, A. T.'s Apgar score totalled 1, with heart rate being graded at 1, and respiratory effort, muscle tone, reflex irritability, and color being graded at 0. A. T. was resuscitated (given oxygen by bag and mask) and by two minutes of delivery her Apgar score had improved to 7, and by five minutes of delivery had improved to 8. A. T. experienced a number of complications secondary to her nine-week prematurity, including respiratory distress syndrome (due to a lack of surfactant), and was intubated and accorded mechanical ventilation from birth until she was four days old. A. T. also presented with apnea (a failure to initiate or maintain pulmonary ventilation) and bradycardia (slow heart rate) due to the immaturity of her nervous system, and was prescribed aminophyllin to stimulate respiration. Finally, as an apparent complication of the stress of delivery, A. T. developed a Grade 3 to 4 intraventricular hemorrhage bilaterally, and on January 11, 1994, a ventriculo-peritoneal shunt (VP shunt) was implanted to address a persistent accumulation of cerebrospinal fluid within the skull (hydrocephalus). Ultimately, A. T. was discharged on February 3, 1994, following a 45-day admission, but continued on apnea and bradycardia monitors. In addition to the foregoing complications associated with prematurity, A. T. also presented with an immature immune system. Pertinent to this case, given her degree of immaturity (9 weeks), A. T. continued to be highly susceptible (high risk) for bacterial infection on April 30, 1994. On April 30, 1994, at approximately 4:45 p.m., A. T., accompanied by her mother, presented to the emergency room at Coral Springs Medical Center, Coral Springs, Florida. At the time, her mother advised the triage nurse that A. T. had a fever, with decreased appetite. The mother also stated that "baby is not herself," was "sleeping more than usual," and was "not eating much." The mother further advised that the infant's twin "sister has bad cold." Weight was recorded as 11.03 pounds, temperature as 103.2 degrees Fahrenheit, heart rate as 160 beats per minute, and respiratory rate as 38 respirations per minute. Respondent was notified at 5:05 p.m. and saw A. T. at 5:20 p.m. At the time, Respondent recorded the following history from the mother: 4 [month old] female infant with a history of prematurity[,] A/B [apnea and bradycardia][,] on A/B monitoring at home and hydrocephalus S/P [status-post] VP shunt placement who presents fever, runny nose, nasal congestion and coughing of 1 day duration[.] She also has been moaning and has decreased her intake somewhat. No diarrhea or vomiting according to mother. Respondent recorded the following results of his physical examination: PE [physical examination]: Active, alert, slightly irritable, not in distress HEENT [head, eyes, ears, nose, and throat]- VP shunt, valve pumps well. TM's [tympanic membranes of the ear] are clear . . . [without] injections or exudate. Slightly hyperemic [reddened] throat . . . [without] exudates. Lungs- transmitted URT [upper respiratory tract] sounds otherwise clear to [auscultation] Heart- RR [regular rate and rhythm]. No [murmur]. Abd [abdomen]- S & D [soft and depressible], no distension, visceromegaly or masses. Ext [extremities]- good pulses, no edema or cyanosis Neurologic- good cry, suck, grasp, tone and reflexes. No gross asymmetries or deficits. Respondent's physical examination was essentially unremarkable and offered no explanation as to a source of infection that would account for her high fever (referred to as "fever without source"). Indeed, A. T. did not appear toxic, septic, or extremely ill, and her skin did not demonstrate evidence of petechiae or rashes which are frequently, although not always, associated with bacterial infection. Under such circumstances, one possible explanation, given A. T.'s congestion and her sibling's current illness, was to attribute the fever to a cold (a viral infection); however, most colds do not typically cause such a high fever as A. T. demonstrated. In contrast, approximately 10 percent of children who present with fever without source (even without A. T.'s increased risk factors) test positive for bacterial infection. Moreover, some bacterial infections (such as the one A. T. was subsequently shown to have had) can present as a common cold or with influenza-like signs.3 Consequently, bacterial infection could not be discounted absent, at least, a urinalysis and a complete blood count (CBC).4 Nevertheless, Respondent did not record bacterial infection as a differential diagnosis and did not order a urinalysis, complete blood count, or other testing to exclude bacterial infection as the cause for A. T.'s presentation. Instead, without benefit of testing (available on-site) to rule out bacterial infection, Respondent diagnosed A. T. as suffering from a cold (viral syndrome) and upper respiratory infection. While A. T. may have suffered a cold and upper respiratory infection, subsequent testing would demonstrate that she also suffered from a bacterial infection or, more specifically, Neisseria meningitidis bacteremia, a universally fatal disease if not treated.5 Here, by failing to recognize or record bacterial infection as a differential diagnosis, and failing to order appropriate testing before excluding bacterial infection as a probable cause of A. T.'s presentation, Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. At 6:05 p.m., April 30, 1994, Respondent discharged A. T. to her mother's care. Instructions on discharge were to give Tylenol every three-to-four hours as needed for fever; feedings of Pedialyte or formula ad lib (as much as she would take); and to follow-up with Dr. Virdee, A. T.'s pediatrician, in the morning, or sooner, if her condition deteriorated or fever persisted, if her intake or urine out-put decreased, or if she experienced any other problem. The infant was also prescribed Rondec-DM drops, a decongestant and cough suppressant, as needed. Following discharge, A. T.'s mother made three telephone calls to Dr. Virdee between 9:30 p.m., April 30, 1994, and 2:00 a.m., May 1, 1994. Dr. Virdee logged the telephone calls as follows:6 4/30/94 9:30 pm: Call from mom. Ashley's apnea monitor keeps going off. Ashley crying & screaming. Told mom ok to take off monitor provided parents keep under observation. Call back if more. Mom said that it had been considered to D/C the apnea monitor at some recent visits. 5/1/94 12:24 am: Call from mom. Ashley won't sleep. Screaming & crying. Advised parents to take turns in observing Ashley. Ø fever Ø new changes. Suggested that mom take Ashley back to ER for re-eval at any time so that she could feel more comfortable. 5/1/94 2 AM: Received . . . call to my home from mom. Mom v[ery] distraught. Said Ashley not sleeping. No fever. Did not mention any vomiting. Again suggested that she may take Ashley back to ER if she desired but reassure her that I would see Ashley first thing in the morning in the office. Dad said that mom may take her to the ER. At approximately 2:12 a.m., May 1, 1994, A. T., accompanied by her mother, again presented to the emergency room at Coral Springs Medical Center. At the time, the triage nurse noted A. T.'s heart rate as 188 beats per minute and respiratory rate as 80 respirations per minute. A. T. was described as "grossly cyanotic," with respiratory distress, nasal flaring, retractions, cold skin, poor capillary refill, and poor air exchange. A. T. was immediately moved to a room for treatment, with Dr. Morgen noted at bedside. Dr. Morgen's notes were, as follows: PMH [past medical history]- hydrocephalus, VP shunt, 31 weeks born. Mother states was seen in ER earlier tonight and [discharged]. Has been vomiting ("her guts out") with high fever. Apnea monitor going off for last hour . . . [with] changes in color for 1 hour. Dr. Morgen's physical observations were as follows: Child crying actively Grossly cyanotic over entire body Entire skin mottled Cap refill >6 sec. Heart-Tachycardic RR 80 & nonlabored Lungs- sound congested Abd[omen]- soft, . . . [normal bowel sounds]. . . . Skin- no rash, poor skin turgor, cool Moving all extremities Critical care- cyanosis improved immediately . . . [with oxygen]. Still mottled cool skin. Fluid bolus started & taken immediately to ICU [intensive care unit] with Dr. Ortega [Respondent} present. Dr. Morgen's diagnostic impression was septic shock. Such impression was accurate as subsequent developments would confirm the presence of a profound bacterial infection. A. T. was taken to the ICU at about 2:33 a.m., May 1, 1994, and admitted at 2:45 a.m. Respondent performed a physical examination which indicated a temperature of 96.4 degrees Fahrenheit (rectal), a heart rate of 138, blood pressure of 97 over 63, and a respiratory rate of 50. Respondent noted A. T. to be hypoactive, awake, in moderate respiratory distress, and acutely ill. At 2:50 a.m., A. T. was intubated endotracheally and started on mechanical ventilation. At 3:15 a.m., Respondent wrote a number of orders for A. T.'s care. For lab tests, Respondent's orders included a CBC (complete blood count) differential, blood culture, and urine culture. Other orders included an arterial blood gas analysis stat (immediately). However, such studies could not be performed since, due to her state of shock, and related poor periferal profusion, A. T.'s blood could not be drawn. Respondent's orders also included Vancomycin, an antibiotic; however, it could not be administered because the staff were unable to obtain vein access. At 4:15 a.m., Respondent wrote the following progress note: . . . ABG's are still pending due to unsuccessful arterial puncture attempts. The infant's temperature has continued to decrease in spite of multiple attempts to warm her up. She has not responded well to volume challenges. . . . I've spoken to the mother and informed her about the critical condition of the infant with a guarded prognosis. At 5:00 a.m., May 1, 1994, A. T. presented with sudden onset of bradycardia and died, despite efforts to resuscitate her. Autopsy results disclosed the cause of death as Waterhouse- Friderichsen Syndrome (bilateral adrenal hemorrhage) secondary to an overwhelming septicemia (systemic disease associated with the presence and persistence of pathogenic microorganisms or their toxins in the blood) caused by Neisseria meningitidis (a bacterial infection). If timely addressed, Neisseria meningitidis can be successfully treated with a variety of antibiotics.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be rendered which finds Respondent guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint. It is further RECOMMENDED that for such violation the final order place Respondent on probation for a term of two years, subject to such reasonable terms as the Board of Medicine may specify, and impose an administrative fine of $5,000.00. DONE AND ENTERED this 27th day of July, 1999, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1999.
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 to be determined in this proceeding are whether Respondent, John L. Lentz, Jr., M.D., committed the disciplinary violations charged with respect to seven patients in three Administrative Complaints that have been consolidated for the purpose of hearing. If the facts demonstrate that any of the charged violations have been committed, then the appropriate penalty to be imposed for such violations must be recommended.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding, the following findings of fact are made: Petitioner is the state agency charged with the licensing and regulation of the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to these proceedings, Respondent was a licensed physician in the State of Florida, having been issued license number ME 82437. Respondent’s address of record is 15200 Emerald Coast Parkway, St. Marten Unit 506, Destin, Florida 32541. Respondent was board-certified by the Academy of Family Physicians until 2009. He currently holds no board certification in any specialty area, and did not complete any residency other than his residency in family medicine. Respondent went to medical school at the University of South Carolina and initially practiced in that state. He moved to Florida in 2001 and since that time, has worked in a variety of practice settings, including working as an emergency room physician in several hospitals in areas such as Phenix City, Alabama; Panama City, Florida; and Defuniak Springs, Florida. At some point, Respondent became interested in the diagnosis and treatment of Lyme disease, and in approximately 2007, he opened a clinic in Destin named the Lentz Lyme Clinic. Respondent attended four continuing medical education courses that focused on the diagnosis and treatment of Lyme disease. Each of the courses he attended was three to four days long. Diagnosis and Treatment of Lyme Disease Lyme disease is an infectious disease caused by the bacteria Borrelia burgdorferi. Lyme disease is typically transmitted by a tick bite from what is often referred to as a deer tick, more formally known as the Ixodes scapularis tick. The tick is usually very small, and must remain on the person’s skin for approximately 36 hours or more in order for the disease to be transmitted. Lyme disease is generally considered to be endemic to the Northeastern United States, in states such as the New England states, Pennsylvania, upstate New York, Delaware, and northern Virginia. While it is not impossible to contract Lyme disease in Florida, the more persuasive evidence established that it is not prevalent in this state. The most credible, compelling evidence presented established that most people who are diagnosed in Florida with Lyme disease were most likely infected while traveling in a part of the country that is endemic for the disease, and that states in the Southeastern United States are in a low-risk area for Lyme disease. There was some conflict in the testimony concerning the stages and symptoms of Lyme disease, and what factors should be considered in diagnosing the disease at the various stages. The more credible and persuasive descriptions of Lyme disease and its stages describe the disease as having three stages: early localized Lyme disease; early disseminated Lyme disease; and late Lyme disease. The probable stage of the disease at the time a patient presents for diagnosis and treatment determines what is necessary for a diagnosis. Early localized Lyme disease is the disease as it typically presents within the first four weeks of the tick bite. The patient often, but not always, presents with a rash called an erythema migrans, which is generally over five centimeters wide (and can be as large as 19 centimeters) and is sometimes clear in the center, leading to the term “bull’s-eye rash” to describe it. In addition to the erythema migrans, a patient may present with virus-like symptoms, such as fatigue, malaise, fever, chills, myalgia (muscle aches), and/or headache. Often the symptoms at this stage, or any stage, for that matter, are non-specific symptoms that are common to a variety of conditions, including ALS and MS. According to Respondent’s expert, Dr. Cichon, these are conditions that a physician should also consider when diagnosing Lyme disease, Babesiosis, or Bartonellosis. In other words, when a patient presents with symptoms that do not include the erythema migrans, but are vague and non-specific, Lyme disease and co-infections related to Lyme disease should not be the only diagnoses considered. In order to diagnose Lyme disease a thorough history is required, including information on a patient’s travel locations, whether travel included states that are typically endemic for Lyme disease; the time of year the travel occurred; whether the patient engaged in the type of activity (such as hunting, fishing, hiking, or other outdoor activities) that would expose him or her to the possibility of a tick bite; any history of rashes; and whether the patient remembers a tick bite. The history should also include any symptoms the patient is experiencing and when the symptoms began. If the patient reports travel to an endemic area, and presents with an erythema migrans that the physician can examine, a diagnosis of early Lyme disease can be made without confirmatory laboratory tests. At that early stage, laboratory tests would not be particularly useful because they detect antibodies to the Borrelia burgdorferi, as opposed to detecting the bacteria itself. At that early stage of the disease, there is not sufficient time for the body to develop the antibodies necessary for detection through laboratory testing. The second stage of Lyme disease is called early disseminated Lyme disease, which may be characterized by multiple erythema migrans lesions; cardiac symptoms, such as atrioventricular block; arthralgia (joint pain); myalgia; or neurologic involvement, such as lymphocytic meningitis, facial nerve Palsy (Bell’s palsy), or encephalitis. If a patient presents with some combination of these symptoms, along with a history indicating travel to an endemic area and activities in that area consistent with tick exposure, a reasonable prudent physician would seek confirmatory laboratory tests to reach a diagnosis of Lyme disease, assuming the patient presents four weeks or more after possible exposure to a tick bite. The type of test to use is discussed below. Late Lyme disease is characterized by neurological symptoms, such as encephalomyelitis, peripheral neuropathy; and arthritis and arthralgia, usually in a single joint, such as a knee. As with early disseminated Lyme disease, a thorough history and physical is required for a diagnosis, as well as a confirmatory laboratory test. There was a great deal of testimony presented regarding the type of testing that is appropriate for the diagnosis of Lyme disease. Petitioner advocated the use of the ELISA test, followed by the Western blot test, commonly referred to as the two-tiered approach. ELISA and Western blot will be discussed in more detail below. Respondent contends that this two-tiered approach is inaccurate and that other tests are more definitive. His argument regarding the testing to use is consistent with his claim that there are two “standards of care,” one recognized by the Infectious Disease Society of America (IDSA), and one recognized by the International Lyme and Associated Diseases Society (ILADS). The tests recognized as standard for diagnosis of Lyme disease by Drs. Robbins, Anastasio, Robertson, Rosenstock, and Powers, are the two-tiered approach ELISA and Western blot tests. The ELISA is an enzyme-linked immunosorbent assay screening test. If the screening test is positive or equivocal for enzymes indicative of Lyme disease, a Lyme Western blot test is performed to confirm the presence of antibodies to Borrelia burgdorferi. For patients with early Lyme disease, the two-tier testing process may produce false negatives because the patient has not had sufficient time to develop antibodies in response to the bacteria. For those with late Lyme disease, the test is highly sensitive and specific because late Lyme disease patients have ample time to develop antibodies. The two-step approach is recommended by the Centers for Disease Control (CDC) because it provides for both sensitivity and specificity. Usually lab tests are either sensitive or specific, but not both. For a test to be considered “sensitive,” there are no false negatives. ELISA is considered a sensitive test. Specificity refers to the specific antibody bands being evaluated. With Western blot, there is an examination of different specific antibody bands. A Western blot IgM test looks for antibodies that are created initially from white blood cells that specifically attach to the infectious organism. A Western blot IgG looks for a different set of antibodies that continue to persist long after the infection is gone. A Western blot IgG is considered positive if five of the ten antibody bands are positive, while an IgM is considered positive if two of three bands are positive. The ILADS guidelines criticize use of the ELISA and Western blot tests because in the organization’s view, the two- tiered testing lacks sensitivity. The guidelines state that several studies “showed that sensitivity and specificity for both the IgM and IgG western blot range from 92 to 96% when only two [as opposed to five] specific bands are positive.”2/ While the ILADS guidelines criticize the two-tiered approach represented by ELISA and Western blot and indicate that other testing has been evaluated, “each has advantages and disadvantages in terms of convenience, cost, assay standardization, availability and reliability.” The ILADS guidelines do not expressly advocate not using the ELISA and Western blot, and note that while other tests remain an option to identify people “at high risk for persistent, recurrent, and refractory Lyme disease,” the tests have not been standardized. Dr. Michael Cichon, testifying for Respondent, opined that the ELISA and Western blot tests had little value and that Respondent’s failure to use them was not a departure from the standard of care. However, while at hearing he denied that he would order either test, in his deposition he indicated that he would order both tests, as a guide to diagnosis. His testimony that the ELISA and Western blot tests are not useful in the diagnosis of Lyme disease is rejected as not credible. Clear and convincing evidence at hearing established that a reasonable, prudent physician who is presented with a patient having possible exposure to Lyme disease occurring four weeks or more before seeing the physician would order the two- tier testing of ELISA and Western blot if it was appropriate to test for Lyme disease. While performing other tests in conjunction with the two-tier tests is not per se a departure, the standard of care requires either ordering the ELISA and where necessary, the Western blot, or reviewing any test results for these tests previously obtained by the patient. Treatment of Lyme disease also depends on the stage at which the condition is diagnosed. If a patient is diagnosed with early localized Lyme disease, a single course of doxycycline for 14 to 28 days is generally appropriate. Early disseminated Lyme disease and late Lyme disease may be treated with IV antibiotics, for a similar period of time. In summary, the standard of care in the diagnosis and treatment of Lyme disease requires a physician to take an appropriate medical history, perform a physical examination, obtain objective laboratory test results in the absence of an erythema migrans rash, and refer patients who do not improve after an initial course of antibiotic treatment to an infectious disease specialist for further evaluation. An appropriate history must include the information described in paragraph nine, and the testing to be ordered should include an ELISA and, where positive or equivocal, a Western blot test. Diagnosis and Treatment of Babesiosis Babesiosis is a parasitic disease of the blood caused by infection with Babesia. Babesiosis, like Lyme disease, is typically transmitted by a tick bite, and can be transmitted by the same tick that carries Lyme disease. There are occasions when a patient properly diagnosed with Lyme disease also will have Babesiosis as a co-infection. It is, however, not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Babesiosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. At all times material to the allegations in the Administrative Complaints, the standard of care for the diagnosis and treatment of Babesiosis included the physician taking an appropriate medical history, performing a physical examination of the patient, and obtaining objective laboratory test results in order to make an evidence-based diagnosis. As with Lyme disease, the patient’s medical history should contain information regarding the patient’s travel; whether they had exposure to a tick bite; whether they recall being bitten by a tick; as well as what symptoms the patient is experiencing. Babesiosis typically presents with virus-like symptoms, fever, sweats, and the identification of Babesia parasites in the patient’s blood. The tests that a reasonably prudent similar physician would order to determine whether a patient had Babesiosis are either a blood smear to identify Babesial parasites or a polymerase chain reaction (PCR) amplification of Babesial DNA. Should a patient be diagnosed with Babesiosis, the normal and customary treatment is a ten-day course of clindamycin and atovaquone. Diagnosis and Treatment of Bartonellosis Bartonellosis is an infectious disease caused by bacteria of the genus Bartonella. It is generally transmitted by lice or fleas on a person’s body, coming off of other animals, such as rats. It also can be transmitted through a cat scratch, as the cat gets fleas under its claws by scratching itself. As is the case with Babesiosis, a family practice physician is unlikely to diagnose Bartonellosis. It is not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Bartonellosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. In order to make a diagnosis, a thorough history and physical is required, along with objective laboratory test results. A physician should inquire about exposure to animals that could carry fleas, ticks, or lice, and whether there had been any recent instances where the patient has been scratched by a cat. The symptoms of Bartonellosis are nonspecific and include fever, headaches, myalgia, and arthralgia. The generally accepted test used to confirm a diagnosis of Bartonellosis would be a PCR amplification of Bartonella DNA, or paired blood serologies. DOAH Case No. 15-2888PL; DOH Case No. 2011-15106 (Patient C.C.) From approximately September 28, 2010, through approximately February 28, 2012, Respondent provided medical care and treatment to patient C.C. At the time of her original presentation to Respondent, C.C. was 27 years old. Prior to seeing Dr. Lentz, C.C. had a series of orthopedic injuries. For example, in 1998, C.C. was involved in a serious car accident, resulting in multiple broken bones and internal injuries requiring a two-week stay in the hospital. C.C. joined the Air Force in 2006, where she served as an aircraft mechanic. During basic training she suffered an injury to her shoulder, which caused problems with her neck, back, and shoulder. While in the military, C.C. was involved in two additional accidents: she broke her wrist in a motorcycle accident at some point, and on March 31, 2009, she had a second accident where the car she was driving was struck by another vehicle. While C.C. denied any injuries as a result of this second accident, shortly thereafter in July 2009, she had neck surgery because of discs impinging on the nerves in her neck. C.C.’s work as an aircraft mechanic required her to work in the fuel tanks of an airplane, which is a very confined space. C.C. is approximately 5’10” tall, and the work she performed required her to become contorted in a very small space for approximately 13 hours at a time. After her neck surgery, she started having increasing amounts of pain in her back and hips, to the point where she could no longer perform her job duties and in August of 2010, resorted to a wheelchair because of her inability to walk. Although she consulted multiple doctors both in the military and through referrals to outside physicians, she did not discover the cause of her pain. On or about September 28, 2010, Respondent evaluated C.C. for complaints of severe back, buttock, and right leg pain. When she presented for her first office visit, Dr. Lentz’s review of symptoms indicated that C.C. had a frontal headache with pain at a level of 10 out of 10; sensitivity to light and sound; loss of hearing and buzzing; nausea but no vomiting; withdrawal symptoms described as sweats when she did not take Ultram or Lortab; and feelings of hopelessness and emotional lability. His physical examination reported that C.C. was in a wheelchair, and documented “soles of feet painful, SKIN: rashes, soles of feet red, NEURO: paresthesia, pain, tender extremity.” At that time, Respondent diagnosed C.C. as having chronic fatigue syndrome and chronic pain syndrome. In C.C.’s history, Respondent noted that she “grew up in Texas/Arkansas-hunting, forests, etc. There is no notation of recent travel on this first visit. Dr. Lentz asked her about any flu-like symptoms, which she denied having. Many of the symptoms listed by C.C. are general symptoms that are common to a variety of ailments. Respondent, however, focused only on chronic fatigue, chronic pain, Lyme disease, Babesiosis, and lupus. On this first office visit, Respondent prescribed CD57, C3a, C4a, and eosinophilic cationic protein (ECP) laboratory tests of C.C.’s blood. With respect to the order for CD57, Respondent listed Lyme disease as a diagnosis. For the C4a and C3a, he listed Lyme disease and Lupus as the diagnoses, and for the ECP he listed a diagnosis of Babesia infection. Respondent did not prescribe an immunoassay (ELISA) test or Western blot test for Borrelia burgdorferi for C.C. The ECP test result for C.C. collected on October 6, 2010, was 20.8. The reference range for a normal test result is 1-10. The notation for the test on the lab result states: This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics of this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. It has not been cleared or approved by the US Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. On or about October 15, 2010, Respondent diagnosed C.C. with Lyme disease. He based his diagnosis of Lyme disease on the results of the CD57 blood test. The CD57 test is a cluster designation test that measures a marker found on lymphocytes, which are a type of white blood cell that are sometimes referred to as natural killer cells. Although Respondent claimed at hearing that he did not consider the test to be definitive, in his deposition he indicated that he believed that it was in fact definitive. Dr. Cichon, on the other hand, testified that the CD57 test used by Dr. Lentz is not a definitive test for Lyme disease, but is useful for measuring the progress of treatment. At least one test result for C.C. reflecting the results for a CD57 panel has the following notation from the laboratory: This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. On or about October 15, 2010, Respondent also diagnosed C.C. with Babesiosis. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.C. He based his diagnosis on the ECP test. On October 15, 2010, Dr. Lentz received an e-mail from C.C.’s roommate, M.B., informing him that C.C. had visited the emergency room over the weekend because of the level of her pain. The e-mail asked whether C.C. could begin with her treatment before her next appointment. In response, Dr. Lentz called in prescriptions for doxycycline and Cleocin, both of which are oral antibiotics. On or about October 18, 2010, Respondent described C.C. as being in no acute distress, with a gait that is within normal limits. He also noted some wheezing, pain all over, tears, and cramps in her muscles. Respondent prescribed long-term IV antibiotic therapy and referred C.C. to a specialist for venous port placement for the administration of intravenous (IV) antibiotic therapy. The specific medications prescribed at this visit are acetaminophen-oxycodone 300 mg - 7.5 mg oral tablets to be taken three times daily; Cymbalta 30 mg oral, once a day; Flagyl 500 mg oral tablets, to be taken three weeks on, one week off; heparin 5000 units/ml injectable solution, once a day; Omnicef 300 mg oral capsules, once a day; Interfase Plus Prothera, a supplement; and boluoke lumbrokinase, also a supplement. At the October 18, 2010, visit, he also ordered a Fry test for Bartonellosis and prescribed intravenous vancomycin, with weekly vancomycin trough levels. Dr. Lentz testified at hearing that the prescription for vancomycin was to treat Bartonellosis.3/ However, at this juncture, no diagnosis for Bartonellosis had been made. Heparin is an anticoagulant that is used for a variety of issues, such as blood clots, pulmonary emboli, and Berko emboli. It is also used in coronary heart disease if a patient has a myocardial infarction. The more persuasive and credible testimony established that it was below the standard of care to use heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis. Not only did heparin have no efficacy, it had the potential to be very dangerous for C.C., or any other patient. On October 28, 2010, Respondent noted that the vancomycin was at 1.5 grams and still not therapeutic, and ordered that the medication be changed to Primaxin and that the Omnicef and vancomycin troughs be stopped. On November 10, 2010, Respondent noted that C.C. was experiencing flu-like symptoms, but was now resting fewer hours each day. For the first time, he noted “past 4 years in military=Virginia, Canada, Honduras, as sites for exposure to Lyme.” He also noted “no wheelchair, but slow to move, pain to rt LS-hip-leg.” He continued to list her diagnoses as Lyme disease, Babesiosis, chronic pain syndrome, and chronic fatigue syndrome. Respondent also saw C.C. in the office on December 8, 2010, and January 10, 2011. At the December 8, 2010, visit, he discontinued the use of Flagyl because of her nausea and switched to Tindamax (one tablet daily for three weeks, then off one week) instead. On January 19, 2011, Dr. Lentz received an e-mail from C.C.’s roommate regarding a fall C.C. had over the weekend. As a result, he wrote an e-mail to C.C. and told her to stop the Tindamax and “add the neurotoxins to remove the neurologic toxins that are being created by the antibiotics.” He also directed her to stop the heparin injections, as she needed to be off of heparin before having some hand surgery to remove a cyst. C.C. returned for an office visit on February 9, 2011. At that time, Respondent’s notes indicate that she was ambulatory but still significantly fatigued and still falling. He noted, “rt hip. sciatic nerve still #1 symptom, can not stand or walk for long periods of time, not sure if neurologic/Lyme or degenerative nerve dis.” In his assessment, he stated she “needs CT lumbar sacrum to r/o orthopedic issue with back pain.” During the course of treatment, Respondent was consistently prescribing OxyContin at 10 mg, three times daily. On March 16, 2011, he referred C.C. to Dr. Beach at Andrews Institute to detox off the OxyContin. He also noted that she had been given 100 percent disability through the military, and would take approximately four months to process out of the military. He also noted “electrical ablation at T9, T10 for chronic back pain per Dr. Nyguen.” Dr. Lentz continued to see C.C. on April 12, 2011; May 4, 2011; and May 13, 2011. Throughout her treatment with IV antibiotics, C.C. experienced problems with nausea, rashes, and diarrhea, but claims that over time, her symptoms began to improve so that she could walk and eventually was able to hold down part-time employment. Toward the end of her military tenure, C.C. needed a referral in order to continue to see Dr. Lentz. To that end, on June 8, 2011, she saw Dr. Janelle Robertson, M.D., a board certified infectious disease specialist at Eglin Air Force Base. Dr. Robertson evaluated C.C. for Lyme disease, and documented her history, including travel history and history of tick bites. She reviewed prior records from Eglin Air Force base that indicated C.C. had an ELISA screening on June 10, 2010 (approximately two and a half months before seeing Dr. Lentz), that was negative. The ELISA test was not only performed before C.C. saw Dr. Lentz, but well after C.C. began suffering the symptoms that led her to seek out Dr. Lentz. Accordingly, the ELISA test was administered at a time at which C.C. would have developed sufficient antibodies for the test to be useful. Dr. Robertson also noted that while C.C. had a history of tick bites in Florida, Texas, and Alabama, she did not report any rashes or illness at or near the time of the tick bites. She also had no history of migratory arthralgia or Bell’s palsy. Dr. Robertson testified credibly that C.C. was having no night sweats, weight loss, changes in vision, palpitations, difficulty breathing, or gastrointestinal problems, and that her primary complaint was back and hip pain. C.C.’s pain remained in the same locations and persisted without resolution since 2009. Dr. Robertson concluded that C.C. did not have Lyme disease, and that her prior negative ELISA test conclusively established that she did not have the disease. She opined that, given that C.C.’s symptoms had persisted since 2009, if she had actually had Lyme disease, she would have developed antibodies that would have been detected with the ELISA test. She also determined that Respondent did not have Babesiosis and recommended to C.C. that she immediately stop the therapy prescribed by Dr. Lentz, because in Dr. Robertson’s view, the therapy was unsafe. C.C. has since transitioned out of the military into civilian life. Although she believes that the treatment by Dr. Lentz was effective in treating her condition, the events since she stopped treatment for Lyme disease suggest otherwise. For example, C.C. testified in her deposition that her treatment ended in mid-May 2011 because Dr. Lentz determined that she did not need more treatment, yet it appears that the military would no longer authorize treatment by Dr. Lentz once C.C. saw Dr. Robertson. Moreover, she continues to have some of the same pain that led her to treatment with Dr. Lentz. In approximately October 2014, she had hip surgery because her “hips are pretty much shot.” She has had three surgeries for kidney stones, steroid injections for temporary relief from her back pain, and acupuncture treatments for her back pain. At least one physician attributed her problem to the kind of work she performed as an aircraft mechanic, and at deposition she indicated that a recent MRI indicated that she has some lumbar narrowing. In short, it appears that the months-long IV antibiotic therapy she endured has provided no lasting solution to her pain. Respondent’s care and treatment of C.C. was a departure from the standard of care in that he diagnosed Lyme disease based upon an inadequate history and no objective laboratory test results from an ELISA test and Western blot. Specifically, Respondent failed to obtain C.C.’s travel history or any history of rashes, possible tick bites, including the size of the tick, and in fact obtained a history devoid of any flu-like symptoms characteristic of Lyme disease. C.C.’s primary symptoms were related to her back pain. Respondent’s own expert, Dr. Cichon, testified that the key to a diagnosis of Lyme disease is the patient’s history.4/ With this inadequate history in mind, Respondent did not obtain an ELISA test or Western blot, but instead relied on a test that, on its face, indicates that it is for investigational use only and should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically-established diagnostic product or procedure. The more persuasive and compelling testimony established that the failure to obtain objective laboratory confirmation of Lyme disease through the use of the ELISA and Western blot tests is a departure from the standard of care recognized by a reasonably prudent similar physician. The more persuasive and compelling evidence also established that C.C. did not actually have Lyme disease, despite Respondent’s diagnosis of the disease. Respondent also departed from the appropriate standard of care by his failure to use the appropriate tests for the diagnoses of Babesiosis and Bartonellosis. His test of preference, the ECP test, is by its own terms, not intended to be used as the sole means for clinical diagnosis or patient management decisions. As stated by Dr. Robbins, it has no clinical relevance and is diagnostic of nothing. Likewise, his credible testimony indicated that use of the Fry test was not appropriate, as it is a proprietary test of the laboratory and not FDA approved.5/ Respondent’s care and treatment of C.C. also departed from the applicable standard of care by prescribing surgery for placement of a venous port for administration of intravenous medication, and by prescribing both intravenous and oral antibiotic therapy in inappropriate and excessive amounts. The more credible and persuasive testimony demonstrated that C.C. did not have Lyme disease, Babesiosis, or Bartonellosis, and therefore did not need any of the antibiotic therapy prescribed. Even had C.C. received a correct diagnosis, the more persuasive evidence demonstrated that the amounts and duration of the antibiotics prescribed were not only unwarranted, but potentially dangerous for the patient. C.C. had the possibility of negative reactions from the many antibiotics prescribed, but also the very real possibility that she has built up a resistance to the antibiotics such that they will be ineffective should she actually need them in the future. Finally, Respondent’s care and treatment of C.C. departed from the applicable standard of care by the prescription of heparin. There was no medical justification for the prescription of an anticoagulant for the treatment of Lyme disease, even if appropriately diagnosed (which did not happen here), and as with the prescription of multiple long-term antibiotics, was potentially dangerous and harmful to the patient. DOAH Case No. 15-2889PL; DOH Case No. 2011-18613 (Patients D.H., S.L., J.L., W.L., and D.D.) Patient D.H. Respondent provided care and treatment to patient D.H. from approximately November 24, 2010, to approximately October 14, 2011. D.H. was previously seen by a physician’s assistant, Thomas Gregory Roberts, who at various times worked under Respondent’s supervision, including the period from April 29, 2009, to May 26, 2010, and again from September 21, 2010, through December 18, 2010.6/ Mr. Roberts had ordered a previous CD57 test for D.H., and had prescribed doxycycline for him on a long-term basis. Mr. Roberts’ office was closing and his records were no longer available, so on November 24, 2010, D.H.’s wife, J.H., e-mailed Dr. Lentz to request laboratory tests and to schedule an appointment for D.H. She stated in part: Dear Dr. Lentz: Both my husband and I have been to you before, but not at your current office. [D.H.] went to Tom Roberts at Village Health Assoc. and was sent for blood work. His CD57 counts were off, so he put him on Doxycycline [sic] and was on it for several months. His last blood work was done in July and by the sound of it showed some improvement, but he told him to stay on the antibiotics. Tom Roberts gave him an order for follow up bloodwork which reads CD57 + NK Cells Dx2793. Since he is currently not practicing that we know of, we are requesting that you please write an order so that [D.H.] can have blood work done and come to you for the results. Based upon this e-mail, Respondent ordered a CD57 test, using the diagnostic code for and reference to Lyme infection, and an ECP test using the diagnostic code for and reference to Babesia infection. He did so without actually seeing D.H., taking a history, or performing a physical examination. Respondent diagnosed D.H. as having Lyme disease and Babesiosis. He communicated the diagnoses to D.H. on December 25, 2010, via e-mail, stating, “CD57 is positive for Lyme and ECP positive for Babesia. Call Amy at 424-6841 for an appointment. Dr. Lentz.” It does not appear from the record that he considered or ruled out any other condition for D.H.’s complaints. Respondent did not prescribe or order for D.H. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests at any time during D.H.’s care and treatment. Respondent did not refer D.H. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis at any time during Respondent’s treatment and care of D.H. D.H.’s first office visit was January 17, 2011. At that time, J.H., D.H.’s wife, who attended the majority of his doctor’s visits with him, testified that his only complaint at that point was fatigue, and ongoing diarrhea she attributed to the lengthy time he had already been on antibiotics. She acknowledged that he checked off those items on a form at the doctor’s office, but was not going to see Dr. Lentz complaining about those: he went simply because of his fatigue. He had no rash at that point, and never complained of a tick bite. Dr. Lentz’s records, however, indicate that he complained about exhaustion; face-neck, jaw, and orbital pain; diarrhea; cramping; stiff and painful joints; mood swings; irritability; explosive [sic]; and poor concentration. From what J.H. could remember, the physical examination Respondent performed on D.H. was very brief. Respondent took D.H.’s blood pressure, possibly looked in his mouth, palpated his abdomen, and did a knee reflex test. She did not remember him doing anything else, except having D.H. fill out a long form. Dr. Lentz’s medical records for this visit contain no prior medical history, no pulse, and no respiration rate. Respondent diagnosed D.H. with Lyme disease. When J.H. asked him if he was sure, Respondent said, absolutely. J.H. had done some research and knew that Respondent had only ordered a CD57 for D.H. She asked him about ordering the Western blot, but he did not order it. She could not remember Respondent’s exact response, but was led to believe that he did not think that the Western blot test was as accurate in diagnosing Lyme disease. At this first visit, Respondent also ordered the Fry test. Results from the Fry test are dated January 25, 2011, and indicate: Based on the accompanying test results for the sample for listed patient and accession number is suggested for follow up confirmation of the putative organism(s). Protozoan: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of a protozoan. PCR testing for putative FL1953 is suggested for follow-up confirmation. EPierythrozoan/Hemorbartonella: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of epierythrozoan/ hemobartonella. PCR or serology testing for the putative epierythrozoan/hemobartonella (Bartonella spp.) is suggested for follow up confirmation and speciation. (emphasis added). The records do not indicate that Respondent ordered any of the follow-up testing recommended by the Fry laboratory which, ironically, is the very testing for Bartonellosis that a reasonably prudent similar physician should order for this condition. His records also do not indicate that he ever added Bartonellosis as a diagnosis for D.H. During the course of his treatment, Respondent prescribed for D.H. the antibiotics Omnicef, azithromycin, and Cleocin, as well as Interface Plus Prothera (an enzyme supplement formulation), boluoke lumbrokinase (a fibrinolytic supplement), atenolol (a beta blocker used primarily in cardiovascular disease, added March 7, 2011), heparin injections (an anticoagulant, also added March 7), artemisinin (an antimalarial, added June 14), Mepron (an antiparasitic, added June 14), Tindamax (added June 14), Plaquenil (an antimalarial), and Vermox (an anthelmintic)(both added August 21). J.H. understood that, based upon Respondent’s explanations, the heparin was prescribed to help other medicines be absorbed into the cells, or something along those lines. She was concerned about D.H. being on the heparin, in part because as a result of him injecting the heparin in his abdomen, D.H. had a lot of bruising and knots all over his belly. She was also concerned because D.H. worked as a boat captain on the Mississippi River, which required him to be away from home for weeks at a time. She was concerned about the ramifications should he have an accident at work when he had no access to medical care. Her concerns were warranted. The couple also had concerns about the number of medications D.H. was taking while under Respondent’s care. He developed blurred vision, did not sleep well, and had chronic diarrhea. When D.H. came home from his last visit, which J.H. apparently did not attend, he reported that Dr. Lentz had said something about having a port placed for the administration of more antibiotics. That shocked her, so before he would go through with port placement, they sought a second opinion. Dr. Patrick Anastasio is an osteopathic physician who is a board-certified infectious disease specialist. During all times relevant to these proceedings, he was a solo practitioner in private practice at Emerald Coast Infectious Diseases in Fort Walton Beach, Florida. He has worked in the area for approximately 12 years. D.H. sought a second opinion from Dr. Anastasio regarding his Lyme disease and Babesiosis diagnoses. To that end, he saw Dr. Anastasio for the first time on September 29, 2011. Dr. Anastasio did not believe that D.H. had the symptoms initially to place him in a high risk group for Lyme disease. During his examination, he looked for signs that would be consistent with Lyme disease, such as arthritis, cognitive problems, or neurological problems, but did not discover any. Dr. Anastasio did not believe that D.H. had either Lyme disease or Babesiosis, but ordered a blood smear, and a Western blot and a Babesia PCR test to rule out the conditions. All tests came back negative.7/ Dr. Anastasio recommended to D.H. that he stop taking all of the medications prescribed by Dr. Lentz, and D.H. did so. It still took months for the diarrhea, most likely caused by the long-term antibiotic therapy, to subside. However, D.H. began to feel better once he stopped taking the antibiotics. Dr. Charles Powers, M.D., testified that Dr. Lentz’s medical records for D.H. were not adequate for the evaluation of whether D.H. had Lyme disease. He also believed that it was below the standard of care to use the CD57 for the diagnosis of Lyme disease as opposed to the ELISA and Western blot tests, and that it was below the standard of care not to order the ELISA and Western blot tests in the absence of an erythema migrans rash that Dr. Lentz could physically observe. Dr. Powers believed that there was no basis upon which to diagnose D.H. with Lyme disease, and therefore any treatment based on this faulty diagnosis would be below the standard of care. Even assuming the diagnosis was correct, Dr. Powers opined that the treatment ordered also was below the standard of care. According to Dr. Powers, a reasonably prudent family practitioner would usually prescribe doxycycline for the majority of cases, as opposed to the regimen of medications used by Dr. Lentz. Prescribing antibiotics the way they were prescribed would include adverse side effects, such as nausea and/or diarrhea with resistance to bacteria; development of C. difficile infection, which can be difficult to treat; and potential for allergic reactions, which can be fatal. Dr. Powers testified that when a combination of antibiotics is being used, with each additional antibiotic prescribed, the risk for complications increases exponentially. His testimony is credited. Dr. Powers also opined that the use of heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis was a departure from the standard of care, and was a dangerous choice for this or any other patient who did not have a need for a blood thinner. Dr. Robbins also believed that Respondent’s care and treatment of D.H. was below the standard of care. He testified that Respondent breached the standard of care by diagnosing D.H. with Babesiosis using the ECP test and the Fry testing for the purpose of diagnosing Bartonellosis. He also testified, consistent with Dr. Powers, that using heparin in the treatment of any of these three diseases was an egregious departure from the standard of care. The testimony of Drs. Robbins and Powers is credited. Dr. Cichon expressed concerns about the amount of medications prescribed by Dr. Lentz to D.H., specifically singling out the prescriptions for Plaquenil and Vermox. While his testimony fell far short of declaring that prescribing these medications represented a departure from the standard of care, his testimony was certainly not a ringing endorsement. It seemed as if he was trying to convince himself that Respondent’s care and treatment of this patient fell within the standard of care. His testimony to that effect is rejected as not credible. D.H. did not have a medical condition that justified the prescription of any of the medications and supplements that Dr. Lentz prescribed, much less for the duration taken. The prescription of any of these medications without a valid diagnosis was a departure from the standard of care attributed to a reasonably prudent similar physician. Patient S.L. Respondent provided care and treatment to patient S.L. from on or about August 17, 2010, to on or about January 7, 2011. On or about August 17, 2010, at her first office visit with Dr. Lentz, S.L. presented with and reported to Respondent a history of heavy rectal bleeding, which occurred every four to five days. At that visit, S.L. informed Respondent that in June, she had been advised to get a colonoscopy. Because of economic constraints, S.L. did not obtain the requested colonoscopy. There is no indication in the patient records for S.L.’s first office visit (or any later visit) that the reason for S.L.’s bleeding prior to his treatment of her had been determined or that it had resolved. S.L. first went to see Dr. Lentz at Hope Medical Clinic8/ because she believed that she had a urinary tract infection. She also had severe back pain, with pins and needles down both legs. Her back pain had started in 2005, following a car accident. S.L. does not recall Respondent ever performing a physical examination, although the patient records indicate that at least a minimal examination was performed. She does recall him talking to her about being from Pennsylvania, but does not recall him asking her about any travel history, whether she had been exposed to ticks, or had ever been bitten by a tick. Dr. Lentz’s medical records for this first visit make no mention of a travel history; no mention of tick exposure; and no mention of any type of rash. Much of the history related to other issues, such as S.L.’s history of bleeding, as opposed to any symptoms that could be said to be indicative of Lyme disease. The symptoms documented are “paresthesis to both legs due to lumbar path. Recent hematochezia. No melena. No upper abd. Pain. No diarrhea. Mostly awake sxs, not hs.” Yet in his assessment/plan notes, he lists diagnoses of lumbago, displacement of lumbar intervertebral disc without myelopathy, and chronic pain syndrome. He prescribed Lyrica, Elavil, Lortab, and ordered a CD57, listing the Lyme disease diagnostic code. There was no medical basis, based on the history presented, to suspect or test for Lyme disease. On September 21, 2010, S.L. presented to Dr. Lentz for a follow-up appointment. At this appointment, Respondent diagnosed S.L. as having Lyme disease. He ordered a Fry Bartonella test as well as an ECP test, and prescribed doxycycline, Omnicef, and Flagyl. On September 30, 2010, S.L. called Respondent and reported throwing up all of her antibiotics, and asked about medication for her nausea. Dr. Lentz added the diagnosis of Bartonellosis without seeing S.L. or performing any further physical examination. The results of the Fry test in the patient records state: “rare (1-4 organisms per total fields observed) coccobacilli adherent to erythrocytes – indicated by yellow arrow(s). This is suggestive of Hemobartonella(1) or Hemoplasma(2).” The notes also state, “[t]his stain is not FDA approved and is for research only.” At S.L.’s next appointment on October 5, 2010, Dr. Lentz prescribed rifampin and Cleocin, as well as Lovenox injections. Lovenox is a low molecular weight heparin that can be given subcutaneously. At the time Dr. Lentz prescribed it, there was no determination regarding the cause of her heavy rectal bleeding just a few months before. On October 19, 2010, just two weeks after starting the Lovenox injections, S.L. presented to the emergency room at Sacred Heart Hospital with complaints of blood in her urine.9/ Physicians in the emergency room attributed the blood in her urine to the Lovenox injections, and discharged her with a diagnosis of hematuria. That same day, she presented to Dr. Lentz and told him about her emergency room visit. Dr. Lentz lowered the dose for Lovenox, but did not discontinue its use. His notes for this visit indicate that she had left flank pain, slight liver tenderness, no masses, and a “light liver test elevated, <2X normal.”10/ He added a diagnosis for Babesiosis, but did not appear to explore what was causing the liver tenderness and elevated tests. Under his assessment and plan, it states: “1. Cut Lovenox BID to QAM. 2. Add Culturelle/probiotics to GI tract due to antibiotics being used, if urine lightens up and less blood on dipstick, then improvement.” Respondent did not prescribe S.L. a PCR amplification or Bartonella or Babesial DNA, or Western blot immunoassay tests at any time during Respondent’s care and treatment of S.L. Respondent did not refer patient S.L. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis, at any time during Respondent’s care and treatment of S.L. S.L. testified that the physicians at Sacred Heart Hospital informed her that there was no reason for her to be on the antibiotics or blood thinner prescribed by Dr. Lentz, and based upon their advice, she stopped the medication regimen he prescribed. The medical records from Sacred Heart do not mention this advice, and she saw Dr. Lentz at least twice after her emergency room visit: October 19 and November 2, 2010. After that, the only communications in Dr. Lentz’s medical records for S.L. appear to be requests for medication related to urinary tract infections as opposed to treatment for Lyme disease, Babesiosis, or Bartonellosis. In any event, she quit seeing Dr. Lentz for Lyme disease, Babesiosis, and Bartonellosis at least as of November 2, and testified credibly that she feels fine. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz’s diagnosis and treatment of S.L. violated the applicable standard of care in that he failed to obtain an appropriate history to diagnose Lyme disease, Babesiosis or Bartonellosis in the first place. He failed to obtain a travel history, any information regarding possible tick bites, and if there was such a bite, the size of the tick and duration of the bite. He also failed to document symptoms that would suggest the possibility of Lyme disease to justify any objective laboratory testing. S.L.’s symptoms were related to back pain and a history of heavy bleeding. Her symptoms simply did not justify testing for Lyme disease. The evidence was not clear and convincing that Respondent failed to perform an adequate examination. As noted above, while S.L. does not remember one, the medical records reflect notations indicating that one was in fact performed. The problem is that the history and physical examination do not support further investigation for Lyme disease. Respondent also departed from the applicable standard of care by relying on tests that were not appropriate for the diagnosis of Lyme disease, Babesiosis, or Bartonellosis. As stated above, there was no basis to test for these conditions at all, but if testing was going to be performed, then the appropriate tests were not the CD57, ECP, and Fry tests, but rather the ELISA, Western blot, PCR, and serologies discussed above. Respondent’s prescription of multiple antibiotics of lengthy duration also violated the standard of care, for reasons discussed above at paragraphs 60 and 79. Likewise, Respondent’s prescription of Lovenox fell below the standard of care. The use of Lovenox for Lyme disease, Babesiosis, and Bartonellosis is not warranted at all, but is especially egregious here, where S.L. had excessive bleeding problems of which Respondent was aware just months before Lovenox was prescribed, with no documentation that the cause of the bleeding had been identified and addressed, and no indication that Respondent did anything to investigate the cause of the bleeding. That he continued to prescribe the Lovenox, albeit at a lower dose, after her visit to the emergency room with hematuria, just compounds the problem. Dr. Cichon testified that Respondent met the standard of care in diagnosing and treating S.L., saying that she had unexplained pain that could be due to Lyme disease. He struggled to identify any symptoms that are commonly associated with Lyme disease. His testimony seemed to indicate anytime there is unexplained pain, Lyme disease is a possibility. His testimony on this issue is not credible. The same can be said for his support of the diagnosis of Babesiosis. Dr. Cichon identified the primary symptoms of Babesiosis as headaches, sweating, and air hunger. S.L. did not have these symptoms, leaving only the ECP test as a basis for diagnosis. Relying on the ECP (which is only slightly elevated) is contrary to Dr. Cichon’s own testimony regarding the primary importance of a thorough history to support such a diagnosis. Similarly, Dr. Cichon acknowledged in his testimony that he could not tell from Respondent’s medical records whether S.L. had any symptoms to support a diagnosis for Bartonellosis, and stated that her symptoms could be due to her lumbar pathology. Given these inconsistencies, his opinion that Dr. Lentz did not depart from the applicable standard of care in the diagnosis of each of these diseases is not credible and is rejected. Medical records must justify the course of treatment for a patient. Dr. Lentz’s medical records for S.L. do not justify the diagnosis or treatment of Lyme disease, Babesiosis, or Bartonellosis. The medical records do not document symptoms that are consistent with the diagnoses of any of these diseases, and fail to provide a complete medical history. Patients J.L., W.L., and D.D. J.L. is the mother of S.L. W.L. is J.L.’s husband and S.L.’s father, and D.D. is S.L.’s son and J.L. and W.L.’s grandson. On September 22, 2010, approximately one month after S.L. began treatment with Dr. Lentz, J.L. wrote him the following e-mail: Dr. Lentz: Thank you for talking with me on the phone today. We are really concerned about S.L. and we can not [sic] express to you how much you are appreciated for all you have done for her. You are a true blessing to our family. My husband was bitten by a tick over the July 4th weekend in MO. He developed the bulleye [sic] rash and went to our family doctor. Dr. Calvin Blount. He was give [sic] 10 days of antibiotics, but no follow up or blood test were ever ordered. We would like to be tested for Lyme. We believe that S.L. might have contracted Lyme before she became pregnant with D.D. and would like him tested also. Here is our information. Please let me know if you need any additional information. Thank you again for all you have done. As noted above, there was an insufficient basis to justify the ordering of any tests related to Lyme disease for S.L. The only basis for ordering tests for D.D. is the suspicion that S.L. may have been infected prior to giving birth to D.D. If there is no basis for suspecting S.L. has Lyme disease, there is no basis for suspecting D.D. has Lyme disease. Respondent did not make an appointment for, take a history from, or perform a physical examination of J.L., W.L., or D.D. Based upon this e-mail alone, he ordered CD57 and ECP tests for all three of them, as well as C4a and C3a tests for J.L. and W.L. To justify ordering the tests, he listed “Lyme Disease (088.81)” under his assessment/plan for each patient. Although he never saw any of these patients, he coded each encounter as “high complexity.” On October 14, 2010, Dr. Lentz sent an e-mail to J.L. stating that “D.D. is positive for Lyme and negative for Babesia.” On October 24, 2010, Dr. Lentz sent an e-mail to J.L. stating, “W.L. C4A is back=20,000+ indicative of active Lyme.” On October 25, 2010, Dr. Lentz sent an e-mail to J.L. which stated, “[t]he CD57 is 50=positive, and the ECP is 11.5=positive for Babesia. My initial charge is $400 and $200 for return visits. Since I will be seeing both you and [W.L.], I will drop that to $300 initial visits. Call Amy for the schedule.” Dr. Lentz testified that he did not diagnose J.L., W.L., or D.D. with any condition, and did not really consider them to be patients. In his view, he was simply doing a favor for the family members of a patient. However, he created records that referred to each patient as being new patients needing tests for Lyme disease, and included diagnostic codes for the lab tests. With respect to each of them, he made an interpretation of the tests that he ordered. At least with respect to D.D., he admitted in his deposition that he diagnosed D.D. with Lyme disease based on the laboratory tests. Both S.L. and W.L. testified credibly that, based on the communications received from Dr. Lentz, they each believed that he had diagnosed them with Lyme disease, and that he had diagnosed J.L. with Babesia. It is found that he did, in fact, provide diagnoses to J.L., W.L., and D.D., without the benefit of a personal history, or a physical examination. Respondent did not refer J.L., W.L., or D.D. to a specialist in the diagnosis and treatment of infectious diseases such as Lyme disease, Bartonellosis, or Babesiosis. Respondent did not order for J.L., W.L., or D.D. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests. J.L. and W.L. decided to get a second opinion regarding the Lyme disease and Babesiosis diagnoses, and went to see Dr. Anastasio. Dr. Anastasio testified that J.L. did not have the required exposure to or symptoms for Lyme disease. Because she came to him with a Lyme disease diagnosis, he ordered a Lyme Western blot, a PCR for Babesiosis, and a PCR for Bartonellosis. J.L.’s Western blot IgM was negative, with two of the three antibody bands tested returning as absent. The Western blot IgG was negative, with all ten antibody bands returning as absent. J.L.’s PCRs for both Babesiosis and Bartonellosis were negative. Dr. Anastasio testified that he did not believe that J.L. had either Lyme disease or Babesia. His testimony was persuasive, and is credited. Dr. Anastasio testified that, given W.L.’s history of a tick bite followed by a rash, there was at least a basis to believe his symptoms could be an indication of Lyme disease. The tick bite and rash were approximately six months prior to W.L. presenting to Dr. Anastasio, and almost three months prior to Dr. Lentz ordering tests for him. Given these time frames, there was plenty of time for W.L. to develop antibodies to Lyme disease if he was in fact infected with the disease. Dr. Anastasio testified that at the time he saw W.L., W.L.’s symptoms were not consistent with late Lyme disease. Dr. Anastasio ordered several tests for W.L., including a Lyme Western blot, a PCR for Babesiosis, a blood smear for Babesiosis, and a PCR for Bartonellosis. The Western blot test was negative, with zero out of ten antibodies present. Both PCR tests and the blood smear were also negative. Dr. Anastasio concluded that W.L. did not have Lyme disease, Babesiosis, or Bartonellosis, and his testimony to that effect is credited.11/ Respondent failed to meet the applicable standard of care with respect to the care and treatment of patients W.L., J.L., and D.D. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz departed from the standard of care in ordering tests for all three patients when he did so without seeing them, taking a history with respect to any of them, or conducting a physical examination of any of them to determine whether any of the requested tests were warranted or even justified. Respondent also departed from the applicable standard of care when he ordered tests that would not even assist in diagnosing Lyme disease, Babesiosis, or Bartonellosis had testing for those conditions been appropriate. Moreover, Dr. Powers testified credibly that the appropriate way to order tests for a suspected condition is to use the symptoms that are being investigated by the physician ordering the test, as opposed to the suspected disease being considered. For example, one ordering a mammogram would list “screening” or “diagnostic,” not “breast cancer,” because at that point, breast cancer has not been, and might never be, diagnosed. Documenting the symptom as opposed to the disease is important in terms of continuing care, so that there is no confusion by a subsequent health care provider reading the records about a premature diagnosis. Dr. Powers’ testimony is credited. Dr. Lentz also claimed that because J.L., W.L., and D.D. were not his patients, he did not need to have medical records for them that complied with section 458.331(1)(n). However, Dr. Lentz created patient records for all three in order to order the laboratory tests for them. He coded the action taken as having high complexity. The definition of medicine includes “diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition.” § 458.305(3), Fla. Stat. Respondent clearly engaged in the practice of medicine when he wrote prescriptions for tests for the purpose of diagnosing disease. By ordering these tests, creating medical charts for them (however limited they may be), interpreting the test results and communicating those results, he established a physician-patient relationship with J.L., W.L., and D.D. Accordingly, he was required to have patient records that justified the course of treatment (here, the diagnosis of Lyme disease, Babesiosis, and Bartonella). The records presented do not meet that requirement. DOAH Case No. 15-2890PL; DOH Case No. 2012-01987 (Patient C.H.) At the time of the events giving rise to this case, C.H. was a 23-year-old woman. She was married and attending her final year of chiropractic school in Kennesaw, Georgia. C.H. testified that in December 2010, she had experienced a bout with the flu, including an episode where she passed out in the shower, for which she was prescribed a Z-pack, and recovered. She then had gum surgery during the Christmas break, requiring anesthesia, after which she visited her husband’s family in Missouri over the Christmas holiday. After C.H. returned to Georgia, she returned to class for the spring semester. In early February of 2011, she had an episode in class where her heart started beating very rapidly, and upon a physician’s advice, went to the emergency room. Tests given there were normal. Follow-up tests also did not reveal the basis for her symptoms, and in March 2011, her mother contacted Dr. Lentz based upon the suggestion of a family friend who had treated with him. On or about March 20, S.H. contacted Respondent by e-mail regarding her 23-year-old daughter, C.H. S.H. had been referred to Respondent by a family friend. S.H. reported that she had found a checklist for Lyme disease symptoms online, which included some of the symptoms her daughter was experiencing, such as fatigue, rapid heartbeat, chest pain, headaches, blurry vision, and difficulty concentrating. She also related that C.H. was in her final year of chiropractic school and had recently completed her national boards, and thought that some of the symptoms might be related to stress and anxiety from her studies. In that e-mail, S.H. reported to Respondent that C.H. had tested negative for Lyme disease the previous week. Respondent received a copy of C.H.’s negative Lyme disease test report from blood collected on or about March 16, 2011. On or about March 22, 2011, Respondent documented his assessment of C.H. as Lyme disease and chronic fatigue syndrome. He ordered CD57, C3a, C4a, and ECP laboratory tests of C.H.’s blood. At the time these tests were ordered, Respondent had not seen or talked to C.H., taken her history, or performed a physical examination. Respondent did not at any time prescribe an ELISA test or Western blot test for C.H. On April 14, 2011, S.H. e-mailed Dr. Lentz to see if any test results had been received for C.H. Dr. Lentz replied, “CD57 51+ positive for Lyme. Babesia is negative at this time.” When asked how to proceed, he told her she needed to start treatment until the CD57 is over 120.12/ S.H. asked via e-mail whether C.H. should get treatment from Dr. Lentz or her family doctor, saying they would prefer to work through him, as this is his specialty. Dr. Lentz responded, “This is more than a good family physician can handle. I have 35 years of family practice and know first hand. Lyme is a multi-faceted problem and requires extra time and effort to educate and direct this complex problem.” On or about April 18, 2011, Respondent prescribed the antibiotics Omnicef (cefdinir) and azithromycin to C.H. At the time he prescribed these medications, Respondent had not seen C.H., and there is no documentation in the patient records that Respondent made any inquiry regarding potential allergies before prescribing these antibiotics. On or about April 25, 2011, C.H. presented to Respondent for the first, and only, office visit. The medical records for that date contain symptoms that C.H. credibly denies having reported to him, such as double vision, twitching, tremors and shakes, explosive (behavior), and shortness of breath. C.H. does not recall being weighed at that visit, although the record contains a weight for her. It does not however, indicate her temperature, pulse, or respiration rate. She recalls a minimum examination for which she remained clothed in shorts and a t- shirt. During the examination, Respondent asked if she had ever been bitten by a tick or had a rash, and checked some areas of her body for a tick bite/rash, which she denied ever having. Dr. Lentz did not inquire about her travel history. Despite the fact that one of her symptoms was the inability to take a deep breath and had suffered from heart palpitations, his patients do not reflect a temperature, pulse, or respiration rate. At that visit, Respondent added the antibiotic Flagyl (metronidazole) and Interfase Plus Prothera, an enzyme formulation, to C.H.’s medications. C.H. testified that at that visit, Dr. Lentz told her that he was a specialist with numerous years of experience, and that he was the only one certified to be able to treat this, and she would have to be under his constant care. C.H. also testified that he told her she would need to be medicated for the rest of her life, because Lyme disease lives forever in your body, and that she would probably never be able to get pregnant or have children. C.H. was devastated by this information. The entire visit with Dr. Lentz, including both the taking of her history and the physical examination, lasted approximately ten minutes. C.H.’s testimony is credited. On or about June 10, 2011, Respondent prescribed CD57, C3a, C4a, and ECP tests for C.H. On or about July 2, 2011, Respondent prescribed C.H. with Babesiosis. He made this diagnosis completely on the basis of test results, as C.H. had not returned to his office after her first and only visit. On or about July 9, 2011, Respondent added artemisinin (an antimalarial), Hepapro (a nutritional supplement); Mepron (atovaquone, an antiparasitic), heparin injections (an anticoagulant), magnesium oxide (antacid, laxative, dietary supplement), and omega-3 fatty acids to C.H.’s treatment. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.H. At no time during her treatment did Dr. Lentz refer C.H. to a specialist. Indeed, he represented to her and to her mother that he was a specialist in Lyme disease and that he was better equipped to treat these conditions than a normal family practitioner would be. C.H.’s condition worsened rather than improved under the medication regimen Dr. Lentz prescribed. She suffered diarrhea and blurred vision and her other symptoms did not improve. Dr. Joel Rosenstock is a medical doctor licensed to practice medicine in the State of Georgia. He is board certified in internal medicine with a subspecialty in infectious disease, and has practiced infectious disease medicine for over 30 years. During the time related to this proceeding, Dr. Rosenstock was practicing in Atlanta, Georgia, at the AbsoluteCARE Medical Center and Pharmacy. C.H. first presented to Dr. Rosenstock on July 12, 2011, at which time she reported Dr. Lentz’s diagnoses of Lyme disease and Babesiosis. In contrast to her brief visit with Dr. Lentz, her consultation with Dr. Rosenstock lasted two to three hours. Dr. Rosenstock immediately ordered a Western blot test for C.H., which was negative. He conducted a thorough history and physical for her, and asked C.H. questions about her travel history, her dogs and where they slept, her hobbies, etc. He advised her that he did not believe that she had Lyme disease or Babesiosis, and recommended that she stop all of the antibiotics and other medications that Dr. Lentz had prescribed. He warned her that it could take several months before the drugs were out of her system, so relief from the side effects would not be immediate. Within a few weeks of stopping the medications, C.H. was feeling much better and was on her way to feeling back to her old self. Dr. Rosenstock did not believe that any of the tests that Dr. Lentz ordered for C.H. were useful in diagnosing Lyme disease or Babesiosis, and did not believe that heparin served any purpose in treating C.H. Based on the credible opinions of Drs. Powers and Robbins, and the testimony of Dr. Rosenstock as a subsequent treating provider, it is found that Dr. Lentz departed from the applicable standard of care in the care and treatment of C.H. in several respects. First, Respondent departed from the applicable standard of care by ordering blood tests and prescribing antibiotic treatment for C.H. (as well as other medications) when he had never actually seen her. At the time he ordered the blood tests, and at the time he first ordered medications for C.H., he had not obtained a history for her, much less a history that was suggestive of Lyme disease, and had not conducted a physical examination of any kind. All he had as a basis for ordering tests was the e-mail from her mother. This e-mail was an insufficient basis upon which to determine that testing for Lyme disease was warranted. When he did actually see C.H., he failed to perform an adequate physical examination and failed to take an adequate history that included travel history, possible exposure to ticks, how long any tick bite may have lasted, and the size and appearance of the tick. Respondent failed to use the generally accepted tests for the diagnosis of Lyme disease and Babesiosis, instead relying on tests that are meant for investigational purposes and indicate on their face that they are not meant for diagnostic purposes. Moreover, as noted above, at the time he ordered the tests, he had no basis upon which to believe C.H. had Lyme disease. Although even his own expert witness consistently stated that a diagnosis of Lyme disease is based in large part upon a thorough history, here, Dr. Lentz had no history. Dr. Cichon’s testimony that it was appropriate to rely on the information in S.H.’s e-mail about her daughter’s symptoms (keeping in mind that her daughter is an adult, not a child) is rejected as not credible. Respondent also departed from the applicable standard of care by prescribing Omnicef, azithromycin, artemisinin, Hepapro, Mepron, heparin injections, magnesium oxide, and omega-3 fatty acids for a condition that she did not have. Given that C.H. had no condition justifying the prescription of these drugs, the prescriptions were both inappropriate and excessive. They also were prescribed for a duration that was not justified, and exposed C.H. to complications that were unnecessary. Respondent was required to keep medical records that justified the course of treatment. His medical records for C.H. fell well short of this requirement. He failed to document a complete history, an adequate physical examination, or why he did not refer her case to a specialist. He also departed from the applicable standards when he used a diagnosis of Lyme disease as the basis for blood tests at a time when he had never seen the patient. Failure to Timely Report Diagnoses or Suspicion of Lyme Disease to the Department of Health (DOAH Case Nos. 15-2889 and 15-2890) Finally, in DOAH Case Nos. 15-2889 and 15-2890, the Department alleged that Respondent failed to report his diagnoses of Lyme disease or suspicions of Lyme disease for patients D.H., J.L., W.L., S.L., D.D., and C.H. to the Department of Health. Section 381.0031, Florida Statutes (2010-2011), requires certain licensed health care practitioners and facilities in Florida to report the diagnosis or suspicion of the existence of diseases of public health significance to the Department of Health. Lyme disease is one of the diseases identified by rule that meets the definition of a disease that is “a threat of public health and therefore of significance to public health.” § 381.0031(2), Fla. Stat.; Fla. Admin. Code R. 64D-3.029. There are forms that are identified by rule for use in reporting these cases. Fla. Admin. Code R. 64D-3.030(3). Ashley Rendon is a biological scientist for the Department of Health in Okaloosa County. Ms. Rendon is an epidemiologist whose duties include investigating reportable disease conditions and outbreaks of public health significance in Okaloosa County. According to Ms. Rendon, whose testimony is consistent with the Department’s rules on this subject, all diagnosed or suspected cases of Lyme disease must be reported to the Department. Once reported, the county health office will conduct an analysis of the reported diagnosis or suspicion, based on a “guidance to surveillance” document, to determine whether the reported case meets the definition for Lyme disease such that the case needs to be reported to the statewide system and to the CDC. Ms. Rendon testified that whether a suspected case or a diagnosis meets the case definition is not for the practitioner to decide. Ms. Rendon’s testimony is credited. According to Ms. Rendon, the Department maintains records both for those reported cases that met the case definition and those reported cases that did not. For 2010, there was one case of Lyme disease that was confirmed, probable, or suspect. None were reported for 2011. There were seven to eight additional cases that were reviewed, but not reported as probable, confirmed, or suspect. Not all reported results are confirmed by ELISA or Western blot. Ms. Rendon reviewed the records of the Department to determine whether Dr. Lentz had reported any cases of Lyme disease, whether suspected or diagnosed, to the Department. There was one instance where a patient of Dr. Lentz’s apparently called in and asked questions, but there was no record of Dr. Lentz or anyone in his office reporting Lyme disease. Dr. Lentz claimed that he had at least on one occasion attempted to report in the past, but that he could not say if he had reported any of the patients named in the Administrative Complaints. He claimed that the Department would not accept reports that are not supported by two-tier testing results, so he stopped trying to report. His claim is rejected as not credible. There is clear and convincing evidence to establish that Respondent failed to report his diagnoses of Lyme disease for patients D.H., J.L., W.L., D.D., S.L., and C.H. General Observations Of the seven patients presented in this proceeding, Dr. Lentz saw only two before ordering tests for Lyme disease and in some cases, Babesiosis or Bartonellosis. With respect to C.H., not only did he fail to see her before ordering testing, but he ordered medications for her without ever obtaining a medical history or performing a physical examination. Some of the patients specifically requested testing for Lyme disease. However, it is the physician’s responsibility to determine whether there is any realistic reason to believe that a patient has a need for such tests. Moreover, in several instances, the general, non-specific symptoms related by the patients suggest several other alternative conditions that could cause the patients’ problems. Even Respondent’s expert opined that Lyme disease, Bartonellosis and Babesiosis share a lot of general, non-specific symptoms with other illnesses, including serious diagnoses such as ALS, MS, and rheumatoid diseases. These are all, according to Dr. Cichon, differential diagnoses that a physician should sometimes consider when trying to find a diagnosis. Yet with all of these patients, Dr. Lentz went straight to Lyme disease every time. He did not consider much of anything else when even to a lay person, the records cry out for a more thoughtful and measured approach. In short, it seems that Dr. Lentz wanted to find Lyme disease regardless of the symptoms presented, and so he did. By doing so, he cost these patients not only the money used for testing and, with respect to C.C., W.L., S.L., and C.H., subjecting them to treatments they did not need and, in at least with respect to S.L., could not afford, but he subjected them to a treatment regimen that made them miserable, was of questionable benefit, and exposed them to unnecessary risks. Petitioner presented the expert testimony of Dr. Charles Powers, a general family practitioner, and Dr. William Robbins, an infectious disease specialist. It also presented the testimony of subsequent treating physicians: Dr. Janelle Robertson, Dr. Patrick Anastasio, and Dr. Joel Rosenstock. Each subsequent treating physician testified credibly that the symptoms presented simply did not justify a diagnosis of Lyme disease, and the testing they either conducted or reviewed did not indicate a basis for such a diagnosis. Their testimony was consistent with that of both expert witnesses presented by the Department, and the testimony of these subsequent treating physicians and expert witnesses have been accorded great weight. Respondent presented the testimony of Dr. Michael Cichon, a retired infectious disease specialist. Dr. Cichon’s testimony was in many respects inconsistent, and at times he seemed to be struggling to actually support the care and treatment that Respondent performed in these cases. While he championed Respondent’s use of the CD57, the ECP, and the Fry test, he also admitted that he seldom, if ever, used some of these tests, and that there were problems with standardization of the tests. Moreover, the tests themselves indicated on their face that they were for investigational, as opposed to diagnostic, use, and should not be used as the sole basis for diagnosis of patients. Because of the significant inconsistencies with his testimony and the contrasts between what he advocated and what Dr. Lentz sometimes did, his testimony is given little weight.
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 has violated section 458.331(1)(g), (m), and (t), as alleged in the three Administrative Complaints at issue in this proceeding; and by the findings that Respondent violated section 458.331(1)(t) with respect to all seven patients, Respondent is guilty of repeated malpractice. It is further recommended that the Board of Medicine revoke his license to practice medicine in the State of Florida, impose an administrative fine in the amount of $30,000, and impose costs pursuant to section 456.072. DONE AND ENTERED this 8th day of July, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 8th day of July, 2016.
The Issue Whether Respondent committed the offense set forth in the Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43, and Chapters 456 and 458, Florida Statutes. Respondent is at all times material to this case a licensed physician in the state of Florida. As such, he is subject to disciplinary action for failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable, prudent similar physician as being acceptable under similar conditions and circumstances. Iribar has been disciplined on two prior occasions. Both cases involved standard of care violations. In Case No. 113487, the Board of Medicine entered a Final Order on April 20, 1992, disciplining Respondent for multiple violations of Section 458.331(1)(t) related to, among other things, prescribing errors. In Case No. 1991-03407, the Board of Medicine entered a Final Order on July 17, 1995, disciplining Respondent for additional prescribing violations. On August 25, 1997, C. H. required medical attention for pain and swelling in his left knee. By the time he was "worked in" at the office of his primary care physician, C. H. was unable to get around without the aid of crutches. In seeking relief for his knee problem, C. H. set in motion a chain of events which would cost him his life. C. H. had been for years a patient at the clinic where Iribar practiced medicine in partnership with Dr. Raul Alvarez (Alvarez). C. H. had a complex medical history, and had long been under the care of Alvarez. Iribar had never seen C. H., but was covering his partner's emergencies on August 25, 1997. C. H.'s knee swelling, which was visible from across a medical examining room, plainly qualified as a matter which needed prompt attention. The clinic had an extensive chart on C. H. It contained records of many office visits, tests, and information concerning care received at other locations which occurred over a period of years in which Alvarez served as C. H.'s primary care doctor. As a partner in the practice, Iribar would of course have been authorized to read every word on the chart before, during or after C. H.'s visit. Numerous references in the chart address real or perceived allergies. At many places in C. H.'s chart, an allergy to aspirin in indicated. In many other places, C. H. is said to be allergic to penicillin as well as aspirin. Iribar's focus in his lone encounter with C. H. was totally upon the need for emergency attention to the swollen and sore knee. On August 25, 1997, it was the routine in the Iribar/Alvarez practice to maintain a form detailing the patient's history, including allergies, on the inside left cover of the file. C.H.'s chart had such a document and it reflected an allergy to penicillin. Iribar freely admits that he never looked at C. H.'s chart prior to prescribing penicillin for his injured knee. Instead, Iribar testified that he conversed with C. H. while examining him and felt that he could obtain from C. H. an accurate answer to the question of whether he was allergic to any medications. During the examination and treatment process, C. H. was articulate regarding his complex medical history. He enumerated at least six medications which he was currently taking. Iribar testified that he asked C. H. if he was allergic to any medications and C. H. responded "aspirin." Iribar states that he informed C. H. that he was going to place him on oral penicillin, which might later be discontinued depending upon the outcome of lab results. According to Iribar, C. H. failed to inform him of a penicillin allergy. For reasons more fully set forth below, the undersigned does not credit Iribar's recollection that he in fact asked C. H. if he had allergies. Neither does the undersigned credit Iribar's testimony to the effect that he informed C. H. of his intent to administer penicillin. Apart from that dispositive fact, the undersigned does credit Iribar's account of his encounter with C. H. Based upon that testimony and the corroborating opinion of the experts for both sides, the evidence established that Iribar entered the examining room and noted that C. H. had a large left knee effusion with pain, redness, and increased temperature to touch. Iribar properly performed an arthrocentesis (a puncture through a joint capsule to relieve an effusion), removing 20cc of yellow pus-like material to relieve the pain. He then prescribed ibuprofen for pain and Pen VK, which is in fact penicillin, to prevent infection. Penicillin is, for most patients, safe and effective for the prevention of infection following a procedure such as the one performed on C. H. Alternative antibiotics exist and would have been prescribed for C. H. had Iribar been aware of the existence of a possible allergy. For an allergic patient such as C. H., the result of taking penicillin can be, and in this case was, swift cardiac arrest followed by a coma from which the patient never emerged. He died five months later. Expert witnesses for both sides agree, and the undersigned finds, that it would have been a gross violation of the standard of care to prescribe penicillin to a person known to be allergic. There is no contention that Iribar actually knew of the allergy, and Iribar did not intend any harm to C. H. Instead, the evidence established that Iribar was covering his partner's emergency and trying to help the patient. Thus, the issue is whether Iribar fell below the standard of care of failing to take reasonable steps to determine whether C. H. had a penicillin allergy. In this case, the totality of the record compels the conclusion that Iribar did not take even a first step. He did not inquire of C. H. as to whether he had any allergies, nor did he look at the patient's chart, which would have placed him on inquiry notice regarding the existence of a penicillin allergy. In failing to take either precaution, he fell below the standard of care. Iribar's disciplinary history reveals prior failures in adhering to the standard of care with respect to the professional obligation to ask the questions a doctor needs to ask to determine if a drug should or should not be prescribed. Additionally, his careless response to the Board of Medicine's inquiry regarding his treatment of C. H. is telling. In an undated letter to Board investigator, Lidice Muniz, Iribar stated, ". . . I asked the patient in front of two medical assistants aiding me [Ana Dickinson and Barbara Olesco] if he was allergic to any medication, he replied 'Aspirin' and he denied all other drug allergies." Common sense suggests that Iribar would have been scrupulously accurate in communicating in writing to state investigators about a matter of such importance. Thus, the undersigned takes seriously Iribar's statement that two assistants witnessed the exchange referenced in the letter. Yet, at the final hearing, neither Iribar nor Olesco claimed that this exchange was witnessed by one, let alone two medical assistants. The undersigned carefully observed Iribar's demeanor while under oath. His recollection that he engaged C. H. on the question of allergies is determined to be untrustworthy. Specifically, the undersigned does not credit Iribar's assertion that he asked his patient about allergies. In light of this finding, it is not necessary to address whether Iribar would have been bound to review the chart had C. H. in fact been asked about allergies. With respect to C. H., Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in that he failed to take any step to afford himself the opportunity to know what if any allergies C. H. had prior to prescribing the medication which caused the patient's death.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law and having reviewed the Recommended Range of Penalty under the Florida Administrative Code, it is RECOMMENDED that the Board enter a final order finding Respondent guilty and imposing the following penalty: A fine of $10,000; continuing medical education classes specified by the Board of Medicine; a six- month suspension; two years of probation, with terms set by the Board of Medicine; a letter of reprimand; and requiring Respondent to report to the Board of Medicine regarding procedures he has or will implement to assure appropriate inquiry of patients regarding their allergies in accordance with the standard of care currently prevailing. It is also RECOMMENDED that the Board impose costs associated with the investigation and prosecution of this case in compliance with Section 456.072(4), Florida Statutes. DONE AND ENTERED this 14th day of January, 2003, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of January, 2003. COPIES FURNISHED: Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John E. Terrel, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent is guilty of the isolated Class III deficiency alleged in Count II of the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact Respondent is a licensed, skilled nursing home facility located in North Miami, Florida. Respondent was at all times pertinent hereto licensed by Petitioner pursuant to the provisions of Chapter 400 Part II, Florida Statutes. Petitioner is the agency of the State of Florida with the responsibility to regulate skilled nursing homes in Florida. Petitioner surveys nursing home facilities to evaluate their compliance with applicable rules. Petitioner classifies any deficiency noted by a survey according to the nature and scope of the deficiency. The severity of the deficiency determines the amount of any administrative fine and whether the licensure status of the facility should be "standard" or "conditional." A licensee’s failure to comply with an applicable statute or rule is a deficiency. A survey results in a report that lists each deficiency that is found, identifies the applicable regulatory standard that the surveyor believes has been violated, provides a factual basis for the alleged violation, and indicates the scope and severity of the deficiency. A facility is given a deadline to correct each alleged deficiency found during the initial survey. Disciplinary action is typically initiated if a facility has not corrected a deficiency as determined by a follow-up survey. Petitioner conducted a survey of Respondent during the period February 28 - March 3, 2005 (the initial survey). Barbara Catinella, who is a registered nurse and an experienced surveyor, participated in the initial survey on behalf of Petitioner. On March 1, 2005, Ms. Catinella observed perineal care being administered to two female residents (identified as Resident 26 and Resident 27). Each resident was being attended to following an episode of urinary incontinence. The first observation began at approximately 2:00 p.m. and the second began approximately thirty minutes later. Two certified nurses assistants (CNAs) administered the perineal care to Resident 26 and two different CNAs administered the perineal care to Resident 27. In both instances, the CNAs failed to properly perform the perineal care. In each instant, the CNAs performing the perineal care failed to open and clean the labia. At all times pertinent to this proceeding, Respondent had a policy as to perineal care for female residents that conformed to accepted perineal care standards. Paragraph 15 of the policy required Respondent's staff to do the following in sequence for a female resident who had suffered an episode of incontinence, whether the episode was of bowel, bladder, or both: For a female resident: Wet washcloth and apply soap or skin cleansing agent. Wash perineal area, wiping from front to back. Separate labia and was area downward from front to back. Continue to wash the perineum moving outward to and including thighs, alternating from side to side, and using downward strokes. Rinse perineum thoroughly in same direction, using fresh water and a washcloth. Gently dry perineum. Instruct the resident to turn on her side. Rinse wash cloth and apply soap or skin cleansing agent. Wash the rectal area thoroughly, wiping from the base of the labia and extending over the buttocks. Rinse. Dry area. 8. At all times pertinent to this proceeding, Respondent had a policy as to perineal care for male residents that conformed to accepted perineal care standards. Paragraph 16 of the policy required Respondent's staff to do the following in sequence for a male resident who had suffered an episode of incontinence, whether the episode was of bowel, bladder, or both: For a male resident: Wet washcloth and apply soap or skin cleansing agent. Wash perineal area starting with the urethra and working outward. Retract foreskin of the uncircumcised male. Wash and rinse urethral area using a circular motion. Continue to was the perineal area, including the penis, scrotum and inner thighs. Thoroughly rinse perineal area in [the] same order using fresh water and clean washcloth. Gently dry perineum following [the] same sequence. Reposition foreskin of uncircumcised male. Instruct or assist the resident to turn on his side. Rinse washcloth and apply soap or cleansing agent. Wash and rinse the rectal area thoroughly, including the area under the scrotum, the anus, and the buttocks. i. Dry area. The perineal care policy was adopted ". . . to provide cleanliness and comfort to the resident, to prevent infections and skin irritation, and to observe the resident's skin condition." Respondent's staff is trained to adhere to the perineal care policy. The perineal care provided Resident 26 and Resident 27 as observed by Ms. Catinella failed to adhere to Respondent's policy and constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. Respondent argued that the failure to adhere to its policy by failing to spread and cleanse the labia would not cause a urinary tract infection as alleged in the Administrative Complaint. Respondent correctly argues that urine, in the body, is sterile and would not by itself cause a urinary tract infection. Most, but not all, urinary tract infections are caused by the e-coli bacteria found in feces. Respondent established that incontinent residents typically receive perineal care from Respondent's staff 10 times during a 24-hour period. Respondent also established that the facility uses only anti-bacterial soap for perineal care. Based on those considerations, Respondent argued that the perineal care observed by the surveyors may have led to a skin irritation, but that it would not have resulted in a urinary tract infection as alleged in the Administrative Complaint. The greater weight of the credible evidence established clearly and convincingly that the failure to spread and cleanse the labia has the potential for various adverse consequences for the resident, including urinary tract infection.3 If staff does not spread and cleanse the labia, the fact that anti-bacterial soap is being used is irrelevant. If the soap does not reach the labia, that area will not be cleansed, regardless of the number of times perineal care is administered during a typical day. Petitioner established the Class III violations pertaining to perineal care as to the initial survey by the requisite evidentiary standard. Petitioner also established that the violations should be considered "isolated" since there were some 55 incontinent residents in Respondent's facility at the time of the initial survey and only two episodes of improper perineal care were observed. Respondent was provided with a correction date thirty days from the conclusion of the initial survey to correct the noted deficiencies by coming into substantial compliance with accepted perineal care standards. The first follow-up survey occurred April 19-20, 2005. Eleanor Kennedy participated in that follow-up survey and testified, in her deposition, as to three incidents of perineal care that she observed. During the course of the follow-up survey, Ms. Kennedy observed two CNAs administering inappropriate perineal care to a female resident referred to as Resident 15. Ms. Kennedy observed that this resident had suffered an episode of incontinence involving both bowel and bladder. In the course of administering the perineal care, the CNAs failed to open and clean the labia. In addition to observing perineal care to Resident 15, Ms. Kennedy observed perineal care administered to a female resident referred to as Resident 16 and a male resident referred to as Resident and to a male resident referred to as Resident The perineal care administered to Resident 16 and to Resident 17 were inconsistent with Respondent's perineal care policy. The CNAs performing the perineal care for Resident 16 did not follow the proper sequence for cleaning. They first washed the resident's abdominal folds and thigh creases and then opened and washed the labia with the same disposable cloth. Ms. Kennedy testified that the sequence of the cleaning is significant because it risked the transfer of bacteria from the areas first washed to an area that could result in a urinary tract infection. The CNAs who performed the perineal care for Resident 17 first washed the resident's face, underarms, and back. Then, without changing water, the CNAs took a clean cloth and washed the resident's groin area, his retracted foreskin area, and the urinary urethral meatus. The CNAs then dried the resident, but failed to follow the required sequence. As with Resident 16, Ms. Kennedy testified that the incorrect sequence followed by the CNAs risked the transfer of bacteria to an area that could result in a urinary tract infection. Although this sequence clearly violated Respondent's perineal care policy, Respondent established that the potential for urinary tract infection as a result of the sequence was reduced because anti-bacterial soap was used. Ms. Kennedy was uncertain as to whether the use of anti-bacterial soap would alleviate the concerns she had as to the care given these two residents. Because of that uncertainty, it is found that Petitioner did not prove that the perineal care provided Resident 16 and Resident 17 constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. The perineal care provided Resident 15 as observed by Ms. Kennedy failed to adhere to Respondent's policy and constituted a failure to provide care and services to prevent potential urinary tract infection as alleged in the Administrative Complaint. On May 26, 2005, Petitioner conducted a second follow- up survey and determined that Respondent was in substantial compliance with applicable regulations.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the Findings of Facts and Conclusions of Law set forth herein. It is recommended that Count I of the Administrative Complaint be dismissed. It is further RECOMMENDED that Petitioner find Respondent guilty of an isolated, Class III deficiency based on Count II of the Administrative Complaint. It is further RECOMMENDED that Petitioner assess an administrative fine against Respondent in the amount of $1,000.00 for the Class III deficiency found in Count II of the Administrative Complaint and that Petitioner's records reflect that Respondent's licensure was classified "conditional" for the period April 20 - May 19, 2005, and that Respondent's licensure was classified as "standard" before and after those dates. DONE AND ENTERED this 6th day of February, 2006, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 6th day of February, 2006.
The Issue The issues in this case are whether Respondent, Carlos S. Contreras, M.D., violated Section 458.331(1)(c), Florida Statutes (2008), as alleged in the Administrative Complaint, filed with Petitioner, the Department of Health, on August 31, 2009, in DOH Case Number 2008-14221, and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Carlos S. Contreras, M.D., is, and was at all times material to this matter, a physician licensed to practice medicine in Florida pursuant to Chapter 458, Florida Statutes, having been issued license number 43908, on or about May 19, 1984. Indictment and Conviction of Dr. Contreras. On or about June 2, 2008, Dr. Contreras was indicted in United States of America v. Carlos Contreras and Ramon Pichardo, United States District Court, Southern District of Florida, Case No. 08-20443 CR - Moreno (hereinafter referred to as the "Indictment"). Generally, the Indictment alleges that Dr. Contreras was involved in a conspiracy to submit fraudulent claims to Medicare for purported Human Immunodeficiency Virus infusion therapy. As it relates to Dr. Contreras, the Indictment was predicated, in part, upon the following “General Allegation”: C.N.C. Medical Corp. (“CNC Medical”) was a Florida corporation, purportedly doing business at 1393 S.W. 1st Avenue, Suite #320, Miami, Florida. . . . CNC Medical was a medical clinic that purported to specialize in treating patients with HIV by providing infusion therapy. From in and around November 2002 through in or around April 2004, approximately $6.8 million in claims were submitted to the Medicare program for HIV infusion services allegedly rendered at CNC Medical. Defendant CONTRARES, a resident of Miami-Dade County, was a medical doctor who purported to order and provide HIV infusion services to Medicare beneficiaries at CNC Medical. CONTRERAS was also the president, director, and registered agent of CNC Medical. Relevant to this matter, Count 2 of the 12-Count Indictment charged Dr. Contreras with conspiracy to commit health care fraud in violation of 18 U.S.C. § 1349 On or about September 11, 2008, Dr. Contreras entered into a Plea Agreement in which he pled guilty to Count 2 of the Indictment, thereby admitting that he was guilty of “knowingly and willfully conspiring with others to execute a scheme and artifice to defraud and to obtain by means of materially false and fraudulent pretenses, representations, and promises money owned by, and under the custody and control of a health care benefits program (as defined as [sic] in Title 18, United States Code, Section 24(b)), in violation of Title 18, United States Code, Section 1347.” On the same date that the Plea Agreement was executed, Dr. Contreras, along with his legal representative, executed and acknowledged the following “Agreed Factual Basis for Guilty Plea”: Beginning in approximately November 2002, and continuing through approximately April 2004, the defendant, Dr. Carlos Contreras (“Contreras”), willfully conspired with his co-defendants, Ramon Pichardo, Carlos Benitez, Luis Benitez, Thomas McKenzie, and others to commit health care fraud, in violation of 18 U.S.C. § 1349. Medicare is a “health care benefit program” of the United States, as defined in 18 U.S.C. § 24. Furthermore, Medicare is a health care benefit program affecting commerce. Contreras was a medical doctor and owned a medical clinic named CNC Medical Corp. (“CNC”). At CNC, Contreras also employed Dr. Ramon Pichardo. CNC purported to specialize in treating patients with Human Immunodeficiency Virus (“HIV”). From approximately November 2002 through approximately April 2004, Contreras approved approximately $6.8 million worth of fraudulent medical bills, signed documents containing false information about treatments purportedly provided to HIV patients, and approved medically unnecessary treatments. As a result of Contreras’ conduct, the Medicare Program (“Medicare”) paid approximately $4.2 million worth of fraudulent bills to CNC and Contreras. CNC was a Florida corporation purportedly doing business at 1393 S.W. 1st Street, Suite #320, Miami, Florida. Corporate records display a business address of 1383 S.W. 1st Street, Suite #320, Miami, Florida. From approximately November 2002 through approximately April 2004, CNC billed the Medicare Program approximately $6.8 million under Contreras’ Medicare provider number, and actually received approximately $4.2 million in payments. Contreras signed checks drawn on CNC bank accounts and would use these checks to transfer funds to various corporate entities owned and controlled by Carlos and Luis Benitez, and others. In total, Contreras transferred approximately $1.7 million dollars [sic] to the Benitez brothers. In or about November 2002, Contreras agreed with his co-conspirators, including Dr. Ramon Pichardo, Carlos Benitez, Luis Benitez, and Thomas McKenzie, to accept HIV patients at CNC and to allow fraudulent bills to be submitted to the Medicare Program under his provided number. Co- conspirators Carlos Benitez and Luis Benitez agreed to provide the staff necessary to operate CNC as an HIV infusion clinic, the Medicare patients that CNC would utilize to bill to the Medicare program, and the transportation for the HIV patients, in return for a share of CNC’s profits. At that time, Contreras knew that CNC would need to pay kickbacks to the patients who visited the clinics, and that the CNC would bill Medicare for HIV infusion services three times a week, for up to three months, for each patient. Contreras’s primary job at the CNC was to see patients, sign medical records, and approve expensive and medically unnecessary HIV infusion treatments. Prior to purportedly treating HIV patients at CNC, Contreras worked at one other Benitez controlled HIV infusion therapy clinic, named AH Medical Office, Inc. At th[is clinic], he learned from the Benitez brothers and McKenzie how to make medical records appear legitimate and how to authorize treatments and sign medical analysis and diagnosis forms for HIV patients, without regard to medical necessity or the patients’ particular ailments. Contreras authorized and approved the use of the drug WinRho (also known as Rho D), along with a mix of various vitamin supplements for most HIV patients he was seeing, knowing that the HIV patients did not need WinRho. . . . . The Agreed Factual Basis for Guilty Plea executed by Dr. Contreras contained the following acknowledgement just above his signature: The preceding statement is a summary, made for the purpose of providing the Court with a factual basis for my guilty plea to the charges against me. It does not include all of the facts known to me concerning criminal activity in which I and others engaged. I make this statement knowingly and voluntarily and because I am in fact guilty of the crimes charged. On or about November 20, 2008, Dr. Contreras entered a plea of “guilty” to Count 2 of the Indictment. The court adjudicated him guilty, dismissed the other charges, and sentenced Dr. Contreras consistent with the Plea Agreement. At the time of the final hearing of this matter, Dr. Contreras was in the custody of the United States Bureau of Prisons serving a 37-month sentence. Based upon the admissions contained in the Agreed Factual Basis for Guilty Plea quoted in Finding of Fact 8, it is clear that the crime for which Dr. Contreras’ was adjudicated guilty involved a conspiracy in which he actually engaged in health care fraud, and not just a plan to do so. The Relationship of Dr. Contreras’ Convictions to the Practice of Medicine. In light of Dr. Contreras’ guilty plea to Count 2 of the Indictment and his acknowledgement of the Agreed Factual Basis for Guilty Plea, there is no doubt that Dr. Contreras engaged in the activities outlined in the Agreed Factual Basis for Guilty Plea. It is also clear that all of those activities related to the practice of medicine. As the Department points out in Petitioner’s Proposed Recommended Order, “[b]ut for Respondent’s license to practice medicine in the state of Florida, he would not have been able to commit the crimes [sic] for which he pled guilty. It was his license to practice medicine that allowed him to work as a physician at CNC Medical Corp., to obtain a [Medicare] provider number, to see patients, to sign medical records, to approve expensive and medically unnecessary HIV infusion treatments and to fully participate in the Medicare program. The foregoing activities were made possible and were a direct result of his status as a licensed Florida physician.” Without his license to practice medicine, there could have been no conspiracy to commit health care fraud. Dr. Contreras relies upon a number of “facts” in support of his argument that the crime for which he pled guilty does not relate directly to the practice of medicine: First, Dr. Contreras argues that the crime involved “conspiracy” to commit health care fraud rather than the actual act of health care fraud. Even if technically correct, the Agreed Factual Basis for Guilty Plea clearly outlines activities involving medical care necessary for the conspiracy to exist. Additionally, but for his license to practice medicine, there would have been no conspiracy; Secondly, Dr. Contreras points out that no restrictions were placed on his practice of medicine or his involvement in the Medicare Program or the Medicaid Program in the Plea Agreement. While correct, the emphasis of the criminal matter was on Dr. Contreras’ activities relating to defrauding the United States government of millions of dollars, rather than his activities as a physician. The government’s interest was a financial one and, therefore, it correctly left his actual practice of medicine to the governmental agencies charged with the responsibility of regulating the practice of medicine; Thirdly, Dr. Contreras points out that the Plea Agreement makes no mention of any breach of the physician- patient relationship. Again, the emphasis of the criminal matter was on Dr. Contreras’ efforts to “steal” government funds rather than the quality or lack thereof of his medical care; and Finally, Dr. Contreras relies upon the testimony of Joseph S. Rosenbaum, Esquire, who represented Dr. Contreras in the criminal matter. According to Dr. Contreras, Mr. Rosenbaum’s testimony was presented in order to “explain the meaning of the documents and background (facts) of the underlying criminal case.” According to Mr. Rosenbaum, Dr. Contreras was “’duped’” and “’used’ by unscrupulous businessmen more clever and ruthless then the Respondent.” Mr. Rosenbaum’s testimony, for which little in the way of predicate was offered, is rejected as contrary to the facts stipulated to by Dr. Contreras quoted in Finding of Fact 8. The crime for which Dr. Contreras was convicted is a crime that “directly relates to the practice of medicine.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Carlos S. Contreras, M.D., has violated Section 458.331(1)(c), Florida Statutes, as described in this Recommended Order, permanently revoking his license to practice medicine in Florida, and imposing a fine of $10,000.00. DONE AND ENTERED this 22nd day of April, 2010, in Tallahassee, Leon County, Florida. LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of April, 2010. COPIES FURNISHED: Ephraim D. Livingston, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 Craig Brand, Esquire Brand Law Firm, P.A. 2816 East Robinson Street, Second Floor Orlando, Florida 32802 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues for determination are whether Respondent must reimburse Petitioner an amount up to $1,051,992.99, which sum Respondent received from the Florida Medicaid Program in payment of claims arising from his treatment of pediatric patients between September 1, 2008, and August 31, 2010; and whether Petitioner is entitled to sanctions in the amount of $210,398.60, and costs of $3,349.86.
Findings Of Fact Petitioner is the state agency responsible for, inter alia, administering the Florida Medicaid Program. Respondent is, and at all times relevant was, a physician licensed to practice medicine in Florida. Respondent was certified by the American Board of Pediatrics in General Pediatrics in 1989. Additionally, Respondent was certified by the American Board of Pediatrics in Pediatric Infectious Diseases in 2005. Respondent's practice is solely hospital-based and exclusive to pediatric infectious disease. Respondent evaluates, and provides care and treatment to, patients in Level III Neonatal Intensive Care Units ("NICU") and Pediatric Intensive Care Units ("PICU") in Miami-Dade, Broward, and Palm Beach County, Florida hospitals.1/ Respondent has never been the subject of any disciplinary proceedings. Exercising its statutory authority to oversee the integrity of the Medicaid program, Petitioner identified Respondent as a Medicaid provider who had submitted a high volume of claims for inpatient recipients. Accordingly, Petitioner conducted a review or audit to verify the claims paid by Medicaid during the audit period. On or about September 14, 2011, Petitioner issued a request for records letter to Respondent. Said correspondence notified Respondent that Petitioner was in the process of completing a review of claims Respondent billed to Medicaid during the audit period to determine whether the claims were billed and paid in accordance with Medicaid policy. The request identified 30 of Respondent's patients and requested copies of the patients' Medicaid-related records, including all hospital records. The requested records were to be submitted within 21 days. Respondent provided records responsive to the September 14, 2011, request for records.2/ Upon receipt, Petitioner organized the submitted records and provided the same to a reviewing nurse, Blanca Nottman. The reviewing nurse preliminarily inspected the same to determine if any policy violations were apparent and noted any findings. Ms. Nottman, in turn, provided the records and notations to Petitioner's "peer coordinator." The peer coordinator maintains a list of all the peers that have a contract with Petitioner. A peer "means a Florida licensed physician who is, to the maximum extent possible, of the same specialty or subspecialty, licensed under the same chapter, and in active practice." § 409.9131(2)(c), Fla. Stat. The peer coordinator then forwarded all records and documents provided by Respondent to Richard Keith O'Hern, M.D., to conduct a peer review of Respondent's claims. Section 409.9131(2)(d), defines a peer review as follows: an evaluation of the professional practices of a Medicaid physician provider by a peer or peers in order to assess the medical necessity, appropriateness, and quality of care provided, as such care is compared to that customarily furnished by the physician's peers, and to recognized health care standards, and, in cases involving determination of medical necessity, to determine whether the documentation in the physician's records is adequate. Dr. O'Hern was certified, in 1979, by the American Board of Pediatrics in General Pediatrics. Dr. O'Hern completed a one-year infectious disease fellowship during his training at the University of Florida in 1977-78. Dr. O'Hern retired from a private general pediatric practice in December 2012. During his thirty-seven year career, he provided care and treatment to approximately 80,000 babies, of which approximately 16,000 were sick with infectious disease issues.3/ During his career, Dr. O'Hern was on three hospital medical staffs, and estimated that his practice involved working in the hospital setting approximately 10-20 percent of the time, with the balance in his office. Dr. O'Hern was never certified by the American Board of Pediatrics in pediatric infectious diseases and would not, at the time of the review, have been eligible to become certified in pediatric infectious diseases. Additionally, Respondent provided unrefuted testimony that Dr. O'Hern would not be permitted to treat Respondent's patients at Level III NICUs and PICUs. Dr. O'Hern received copies of the medical records submitted by Respondent as well as "copies of the worksheets that Medicaid uses to determine the appropriateness of medical reimbursement." For each of the thirty patients, whose encounters were under review for the audit period, Dr. O'Hern reviewed the patient's noted complaint; whether the patient was a new or existing patient; whether the patient was inpatient or outpatient; the medical history, physical exam, and assessment of the patient; and the amount of time spent with the patient. Dr. O'Hern would then, based upon the above information, "determine the level of coding that leads to reimbursement." Upon completion of his review, Dr. O'Hern notated his findings and returned the same to the peer coordinator, who in turn, provided them to the reviewing nurse. The reviewing nurse then "comes up with a review finding that gives the reason for the adjusted or denied claim." As there were findings for adjusting or denying Respondent's claims, Jennifer Ellingen, an investigator for Petitioner, prepared a Preliminary Audit Report ("PAR"). On April 18, 2012, Petitioner issued the PAR to Respondent. The PAR advised Respondent that Petitioner had completed a review of claims for Medicaid reimbursement for the audit period, and a preliminary determination had been made that Respondent was overpaid $1,051,992.99 for claims that in whole or in part were not covered by Medicaid. The PAR advised Respondent that the documentation he provided supported a lower level of office visit(s) than the ones for which he billed and received payment, and that some services for which he billed and received payment were not documented. The PAR notified Respondent that he could (1) pay the identified overpayment within 15 days and wait for the issuance of the final audit report ("FAR"); (2) submit further documentation in support of the claims within 15 days; however, such additional documentation may "be deemed evidence of non- compliance with [Petitioner's] initial request for documentation;" or (3) not respond, and wait for the issuance of the final audit report. The PAR further notified Respondent that the findings contained in the PAR were preliminary in nature, and that it was not a final agency action. Respondent opted to submit further documentation in support of his claims. Upon doing so, the process repeated itself, with the reviewing nurse, now Karen Kinser, reviewing all of the submitted documentation, which was then forwarded to Dr. O'Hern for an additional review. On January 8, 2013, Respondent issued a FAR. The amount previously determined as overpayment in the PAR remained unchanged in the FAR. The FAR further documented that a fine in the amount of $210,398.60 had been applied and costs had been assessed in the amount of $3,349.86. As noted above, upon receipt of the FAR, Respondent timely requested a formal hearing. Rather than examine the records of all recipients served by Respondent during the audit period, a random sample of 30 recipients (patients) was reviewed. For these patients, Respondent identified 701 reimbursements from Petitioner to Respondent during the audit period. At hearing, Petitioner presented evidence specific to three of the 30 patients. A review of the three patients is instructive. Patient 1 was born premature at 33 weeks gestation, with a birth weight of three pounds seven ounces, and was two months old at time of the subject hospitalization. At birth, Patient 1's medical condition necessitated placement in the NICU for three weeks and required nasogastric tube feeding. During the hospitalization under review, the patient's discharge diagnoses included, inter alia, septicemia and streptococcal meningitis. During the hospitalization, Respondent provided pediatric infectious disease care to the recipient. Patient 2 was born on January 27, 2009, at 27 weeks gestation. At the time of the subject admission, Patient 2 was 37 days old, with an adjusted gestation age of 32 weeks two days, weighing 1.040 kg (approximately two pounds five ounces). The admitting diagnoses were prematurity, possible sepsis, respiratory distress, and a femoral fracture. Respondent provided care and treatment concerning a pediatric infectious disease condition, sepsis. The patient was not discharged from the hospital until July 28, 2009. Patient 3 was born prematurely on July 15, 2009. On August 27, 2009, the child was 43 days old with an adjusted gestation of 32 weeks five days and weighed 1.180 kg (approximately two pounds ten ounces). The admitting indications were prematurity, possible sepsis, and respiratory distress. Respondent provided care and treatment concerning potential sepsis, a pediatric infectious disease medical condition. Consistent with the above-findings concerning Patients 1-3, Respondent testified that his typical patient/recipient is premature and weighs approximately 500 grams (approximately one pound). Respondent explained that his patients are immune-compromised and that patients under 28 weeks gestation do not possess an independent immune system. Respondent opined that the greatest cause of morbidity or mortality among these pediatric patients is infectious diseases.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration issue a Final Order dismissing the Final Audit Report. DONE AND ENTERED this 22nd day of May, 2014, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE 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 22nd day of May, 2014.
The Issue The issue in the case is whether the allegations of the Administrative Complaint are correct, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this case, the Respondent was a licensed certified nursing assistant, holding Florida license number 113243. On or about December 14, 2008, the Petitioner submitted to a drug screening urinalysis test at the request of an employer, Maxim Healthcare Services (Maxim). The sample was collected at a Maxim facility located at University Park, Florida. The Forensic Drug Testing Custody and Control Form and the urine sample collection container bear handwritten dates of December 13, 2008. At some point, the dates on the form and the container were overwritten to indicate that the sample was collected on December 14, 2008. According to the Respondent's Response to the Petitioner's Request for Admissions, the sample was collected on April 14, 2008. The Petitioner presented an expert witness who testified as to the testing procedures, including custody and storage of the urine samples to be tested. The expert witness' testimony regarding sample collection and transportation, calibration of equipment, sample storage and testing methodology, and reporting of test results, was persuasive and has been fully credited. According to the documentation presented by the Petitioner's expert witness, the sample collection container was received by the testing laboratory on December 15, 2008, with all transportation packaging and the sample container seal intact. According to the expert witness, the test for which Maxim paid, screened for ten drugs, including marijuana. According to the expert witness, the testing equipment was properly calibrated at the time the Respondent's urine sample was tested. The initial immunoassay test result indicated the presence of a recognized by-product of marijuana (delta nine tetrahydrocannabinol carboxylic acid) in the Respondent's urine sample. Because the first result was positive, a second test was performed using a gas chromatography/mass spectrometry device, which confirmed the presence of delta nine tetrahydrocannabinol carboxylic acid in the Respondent's urine sample. The Respondent denied using marijuana. The Respondent asserted that the test results were inaccurate. The Respondent testified that he had a prescription for, and was taking, hydrocodone at the time he provided the urine sample for the test at issue in this proceeding, but that the test results did not indicate the presence of hydrocodone. The Respondent asserted that the test result was either the result of lab error or that the sample was not his urine. The Petitioner's expert witness testified that the screening tests purchased by Maxim included limited testing for opiates and would not have indicated the presence of hydrocodone in the Respondent's urine. Although the Respondent testified that he had been told by Maxim personnel that the test results should have revealed the presence of hydrocodone, the Respondent's testimony in this regard was uncorroborated hearsay and was insufficient to support a finding of fact. Although the Respondent asserted that the sample tested was either not his urine or was otherwise tampered with, the evidence failed to support the assertion. There was no evidence that the sample was tampered with in any manner when the sample was obtained or during transportation to the testing laboratory. There was no evidence that the seal on the sample collection container was not intact at the time the sample was provided or transported. There was no evidence that the sample was stored improperly. There was no evidence that the testing equipment was not properly calibrated or that the tests were improperly performed. The Respondent testified, without contradiction, that over the course of 20 years in nursing work both before and after the tests at issue in this proceeding, his test results have never reported the presence of marijuana.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Petitioner enter a final order assessing a fine of $250, requiring completion of an IPN evaluation, and imposing a 12-month period of probation. DONE AND ENTERED this 31st day of March, 2009, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 31st day of March, 2009. COPIES FURNISHED: Dr. Ana M. Viamonte Ros, Secretary State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701 Rick Garcia, MS, RN, CCM Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399-1701 Patricia Dittman, Ph.D(C), RN, CDE Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Megan M. Blancho, Esquire Carla Schell, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Michael N. Heimur, C.N.A. 4901 South Salford Boulevard North Port, Florida 34287
