The Issue The issues in this case are whether Respondent violated section 458.331(1)(m), Florida Statutes, by failing to keep legible medical records that justify the course of treatment of a patient, as set forth in the Second Amended Administrative Complaint, and, if so, what is the appropriate sanction.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2015). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458. Dr. Velilla is a licensed physician in the state of Florida, having been issued license number ME 98818. Dr. Velilla's address of record is 12709 Miramar Parkway Miramar, Florida 33027. Dr. Velilla has been a medical director at Evolution MD since the summer of 2010. Dr. Velilla was licensed to practice medicine in the state of Florida during all times relevant to Petitioner's Second Amended Administrative Complaint. Dr. Velilla is Board-certified in internal medicine by the American Board of Internal Medicine. On or about December 29, 2010, Patient C.A. consulted with Dr. Velilla regarding possible abdominal liposuction and fat transfer to the gluteal area. These are cosmetic surgery procedures, undertaken with the object of enhancing the patient's appearance, and are purely elective. On or about February 10, 2011, Dr. Velilla performed an evaluation of Patient C.A. and ordered routine pre-operative laboratory studies. The laboratory report prepared by First Quality Laboratory indicated readings within normal limits for blood urea nitrogen (BUN) at 19.8 and creatinine serum at .7, but an abnormally high BUN/creatinine ratio reading of 30.43. It showed an abnormally high globulin reading at 3.40, an abnormally low INR reading of .79, an abnormally low MCH reading of 25.2, and an abnormally low MCHC reading of 30.7. On or about February 15, 2011, Dr. Velilla reviewed Patient C.A.'s pre-operative laboratory report results. He placed a checkmark next to the high BUN/creatinine reading and the low INR reading. He wrote "Rev." with the date and signed his name on each page. Dr. Velilla testified that he performed a glomerular filtration rate test, a calculation used to check on the functioning of the kidneys, and the result indicated normal renal function. He testified that a BUN/creatinine ratio outside of the normal range could be caused by several factors, and that after his assessment, the reading was not of concern to him in proceeding to surgery. Dr. Velilla did not make any notation on Patient C.A.'s medical records to indicate how or why he concluded that the abnormal BUN/creatinine ratio reading was not of concern. On February 24, 2011, Patient C.A. filled out a "General Consent" form. Patient C.A. agreed to disclose her medical history, authorized the release of medical records for certain purposes, agreed to use skin care products as directed, and acknowledged possible side effects from the use of skin care products. The form also stated, "I understand that Cesar Velilla, M.D. P.A. services generally consist of a series of treatment [sic] to achieve maximum benefit, and this consent shall apply to all services rendered to me by Cesar Velilla, M.D., P.A., including ongoing or intermittent treatments." On February 24, 2011, Patient C.A. filled out a "Medical History" form. Patient C.A. indicated she was not under the care of a dermatologist, did not have a history of erythema ab igne, was not on any mood-altering or anti-depression medication, had never used Accutane, had never had laser hair removal, had no recent tanning or sun exposure, had no thick or raised scars from cuts or burns, and had never had local anesthesia with lidocaine. The form did not ask for information about any prior abdominal procedures, previous liposuction treatments, multiple pregnancies, or abdominal hernias. On February 24, 2011, Patient C.A. signed a "Consent for Laser-Assisted Lipolysis Procedure SLIM LIPOSCULPT." The form did not include consent for fat transfer to the gluteal area or describe risks or possible complications of that procedure. Patient C.A. also signed a "Consent for Local Aneshesia [sic]" form. As Dr. Obi testified, the risks from a fat transfer procedure are generally the same as those of the liposuction procedure; although with a fat transfer, you have additional potential for fat embolism. On or about February 24, 2011, Dr. Velilla performed liposuction of the abdomen and thighs with fat transfer to the gluteal area on Patient C.A. at Evolution MD. Patient C.A.'s liposuction was not the "Slim Liposculpt" laser-assisted procedure. The testimony was clear that the "Slim Liposculpt" procedure would use a laser to melt the fat before liposuction, which could not be done on Patient C.A. because the fat was to be transferred. There was testimony that a laser could be used to improve skin retraction, however. As Dr. Velilla testified, Patient C.A. had requested the fat transfer in addition to the liposuction prior to the procedure. Dr. Velilla discussed the risks of both the liposuction and the fat transfer with Patient C.A., and she consented to have the procedure done. As Dr. Velilla testified, this consent was later documented on the operative report prepared sometime after the surgery and dated February 24, 2011, the date of the surgery. Dr. Velilla's testimony was supplemented by the operative report, which stated in pertinent part: The patient requested liposuction with fat transfer and understood and accepted risks including but not exclusive to bleeding, infection, anesthesia, scarring, pain, waves, bumps, ripples, contour deformities, numbness, skin staining, fluid collections, non- retraction of the skin, deep venous thrombosis, fat embolism, pulmonary embolism, death, necrotizing fasciitis, damage to surrounding structures, need for revision surgery, poor aesthetic result and other unexpected occurrences. No guarantees were given or implied and the patient had no further questions prior to the procedure. Other options including not having surgery were discussed and dismissed by the patient. The operative report adequately documented Patient C.A.'s earlier oral informed consent for liposuction with fat transfer. Patient C.A. did not execute a written informed consent for the fat transfer prior to the procedure. Dr. Velilla also noted in the operative report that the "patient physical examination and pre-operative blood work were within normal limits." Neither the operative report nor any other documentation indicated whether a complete physical examination or a focused physical examination was given, or what that examination consisted of. Patient C.A. was scheduled for a second liposuction procedure on her arms on February 26, 2011. It was decided to defer the procedure on her arms to this later date in order to keep the amount of lidocaine at a safe level during the initial procedure. On or about February 26, 2011, Patient C.A. presented to Evolution MD with complaints of nausea and mild pain. Dr. Velilla was not at the Evolution MD office. Mild pain is to be expected on the second day after a fat transfer procedure, and nausea can be anticipated in some patients who are taking opiods, as had been prescribed for Patient C.A. There was insufficient competent evidence in the record to support a finding that Patient C.A.'s symptoms were unusual or that Dr. Velilla was ever informed of more serious symptoms in Patient C.A. that day. Dr. Velilla spoke by telephone with an Evolution MD staff member about Patient C.A.'s symptoms and instructed the staff member to ask Patient C.A. to wait for his arrival at the office. A "Progress Note" signed on February 26, 2011, by Ms. Amanda Santiago, of Dr. Velilla's office, indicated that Patient C.A. said the pain and nausea were "due to the Vicodin." The note indicates that Dr. Velilla was called, that he stated he might stop the Vicodin and start Patient C.A. on Advil or Tylenol for pain, and that he asked that Patient C.A. be prepared for surgery. The note does not indicate that Dr. Velilla directed that Patient C.A.'s vital signs be taken, or that they were taken. The note states that Patient C.A. decided not to have the procedure on her arms done and that Dr. Velilla was again called. The note indicates that he asked the staff to take pictures of Patient C.A. and ask her to wait for him to arrive. Dr. Velilla did not order Evolution MD staff to take Patient C.A.'s vital signs. Her vital signs were not recorded by Evolution MD staff on February 26, 2011. Contrary to Dr. Velilla's request, Patient C.A. left Evolution MD on February 26, 2011, prior to Dr. Velilla's arrival at the office, and Evolution MD staff were unable to contact her. On or about February 27, 2011, Patient C.A. presented to Coral Springs Medical Center where she was admitted with a diagnosis of severe dehydration, intravascular volume depletion, diarrhea, nausea, and vomiting. Subsequently, Patient C.A. was admitted to the intensive care unit. Patient C.A. remained hospitalized until March 31, 2011. Standards and Ultimate Facts Dr. Obi is a surgeon specializing in plastic surgery. He does not conduct laser-assisted liposuction, but performs what is known as "wet" or "super wet" liposuction, as was performed by Dr. Velilla in this case. He has been a Diplomate of the American Board of Plastic Surgery since 1982. Dr. Obi reviewed Patient C.A.'s medical records from Evolution MD, other related records, and the Second Amended Administrative Complaint. Taken as a whole, Dr. Obi's testimony with respect to the medical history documented for Patient C.A. was not clear and convincing. He testified that Patient C.A. was undergoing a significant operative procedure and that it involved multiple anatomic areas. He also noted that the history did not include information as to whether Patient C.A. had prior abdominal surgical procedures, earlier liposuction, multiple pregnancies, or abdominal hernias. He testified that this information could indicate increased risks of injury and that this relevant history must be documented. Dr. Obi stated that in his opinion the patient history did not meet the minimum standards of the medical records rule. On the other hand, Dr. Obi seemed to have only a partial understanding of what the medical records rule required, and he had no opinion on whether the patient history justified the course of treatment of Patient C.A.--the actual statutory standard that Dr. Velilla was charged with violating in the Second Amended Administrative Complaint: Q. What does the rule say? A: What does the rule say? The medical record rule I believe requires – I can't tell you verbatim what it says. It requires adequate documentation so that in the event that the care of a patient has to be transferred to another healthcare professional the documentation is adequate that the patient, that the professional could immediately step in and take over. Q: Okay. You believe that's part of either the statute or the rule enacted by the Board of Medicine? A: If the Board of Medicine is the group responsible for the medical record rule, then I would say yes. Q: Okay. Have you reviewed what has been alleged in the amended administrative complaint, or second amended administrative complaint, as to the statutory provision for medical record adequacy? A: The statutory, I'm not sure that I have. * * * Q: And do you believe that the records fail to justify the course of treatment of the patient with those history findings? A: That's not what I said. I didn't say it failed to justify. What I said is it wasn't complete. Q: Okay, do you have an opinion as to whether the records fail to justify the course of treatment of the patient? A: No. Q: You don't have an opinion. Okay, thank you. In contrast, Dr. Soler testified that in his opinion the patient history that was documented as part of Patient C.A.'s medical records did justify her course of treatment. With respect to the physical examination, Dr. Obi noted that there was only a single line in the operative record stating that the physical examination was within normal limits. He noted that the documentation did not indicate what had been examined and did not record any specific findings or results of any examination that was conducted. However, he never offered an opinion that the record of the physical examination failed to justify the course of treatment of Patient C.A. Dr. Soler testified that in his opinion, the record of the physical examination did justify the course of treatment of the patient. Petitioner did not show by clear and convincing evidence that the documentation of Patient C.A.'s medical history and physical examination failed to justify her course of treatment. Dr. Obi testified that the medical records should have contained more evaluation or explanation of the abnormal laboratory report results: Q: And so was the check mark, when coupled with that note in the pre op, or in the operative report, sufficient documentation of Dr. Velilla's evaluation of the of the patient's pre-operative lab results? A: In my opinion, no. Q: And what do you base that on? A: If you have an abnormal result, I think it is incumbent on you – it – depending on what the abnormality is, and depending on what your interpretation of that abnormality is, it's incumbent to explain it. Sometimes you need to repeat the tests. Sometimes it may be perfectly within normal limits, but on the laboratory sheet, if it says that it's high, or out of the range of normal, I think other than just check mark, I think you just acknowledge what your thoughts are. Q: And do you remember if there was anything abnormal in Patient C.A.'s pre-operative laboratory results? A: There was one area that I commented on. That was the BUN-creatinine ratio. Q: And what is the BUN-creatinine ratio? A: It's just a ratio of some parameters dealing with kidney function. Q: Okay, and what does that lab result tell you about a patient, if anything? A: Well, you know, it can call your attention to the area, I mean, it can tell you, you know, that the patient has some renal issues. It can tell you that the patient is, you know, potentially dehydrated, it can tell you that the patient, you know, is within normal. But if the values are – if one value is high and the other one is low, it may give you a, a high reading. And that's understandable, but all you need to do is document that. It was Dr. Obi's opinion that the medical records failed to contain a sufficient evaluation or explanation of the abnormal BUN/creatinine ratio laboratory result. He acknowledged that the abnormal result was not necessarily indicative of a renal problem. However, Dr. Obi also testified: Q: Okay. Do you have an opinion as to whether those records are adequate to justify the course of treatment of the patient? A: The failure to document the thought process on this ratio would, in and of itself, not prevent or preclude the operative procedure from being done, if that's your question. At best, Dr. Obi's testimony was thus ambiguous as to whether or not failure to include an explanation of the abnormal laboratory result failed to justify the course of treatment of Patient C.A. Dr. Soler testified that no other documentation or chart entry was required to address the lab report value in order to justify proceeding with the surgery. Dr. Sandler testified that the BUN/creatinine ratio was a renal-related test, but does not itself indicate kidney malfunction. Dr. Sandler also testified that in his opinion, no other documentation was needed prior to proceeding with the surgical procedure. The Department did not clearly and convincingly show that the documentation in the medical records relating to abnormal laboratory results failed to justify the course of treatment of Patient C.A. Dr. Obi testified that Dr. Velilla had a duty to order the taking of Patient C.A.'s vital signs since he was not yet in the office when she returned on February 26, 2011, the date the second liposuction had been scheduled. He testified that if the medical records rule "requires doing what's appropriate at each visit," then Patient C.A.'s records did not meet the requirements of that rule. He testified that if Patient C.A. was an "outlier" in that her symptoms were uncommon, the standard of care required that Patient C.A.'s vital signs be taken. Dr. Obi admitted that there was no documentation in the medical records to suggest that Dr. Velilla had ordered the staff at Evolution MD to take Patient C.A.'s vital signs, but he testified that the order should have been given and that it should have been documented. Dr. Obi testified that there was no written documentation of an informed consent for the fat transfer and that the consent for the "Slim Liposculpt" procedure was consent for a procedure that was not done. Again, Dr. Obi seemed unfamiliar with the specific requirements of the medical records rule: Q: And is, is the –is a written documentation of the fat transfer required by the medical record rule in this case? A: In terms of the actual requirement, it would be my opinion that it should be required. Now, I can't say if it says that for every procedure, every surgical procedure, every invasive procedure, that a written consent must be documented; because obviously, you now, the patient consented. It's implied that the patient consented because she showed up for the procedure. Dr. Obi testified that he was aware that the operative report contained statements that Patient C.A. had been informed of the risks of the fat transfer procedure and that she had specifically consented. He admitted he was unsure as to "which board, or organization, or outfit" requires a written informed consent. Aggravating and Mitigating Factors No evidence was introduced to show that Dr. Velilla has had any prior discipline imposed. There was no evidence that Dr. Velilla was under any legal restraints in February 2011. It was not shown that Dr. Velilla received any special pecuniary benefit or self-gain from his actions in February 2011. It was not shown that the actions of Dr. Velilla in this case involved any trade or sale of controlled substances. On May 17, 2014, Dr. Velilla received a certificate showing completion of an FMA educational activity conducted in Jacksonville, Florida, entitled "Quality Medical Record Keeping for Health Care Professionals."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the Second Amended Administrative Complaint against the professional license of Dr. Cesar Augusto Velilla. DONE AND ENTERED this 8th day of June, 2016, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 June, 2016.
Findings Of Fact At all times pertinent to the issues herein, the Board of Medicine was the state agency responsible for the licensing of physicians and the regulation of the practice of medicine in this state. Respondent was licensed as a physician in Florida and holds license number ME 0017915. He practices medicine, specializing in psychiatry, in Clearwater, Florida. He is board certified in that specialty. On September 7, 1987, Patient #1, a 55 year old married female, whose husband had recently separated from many years in the armed service of the United States, came to see Respondent at his office, complaining of severe headaches, loneliness, depression, and a lowering of self esteem. She had been referred to him by physicians at the U.S. Coast Guard Station Dispensary. Respondent examined Patient #1 and found her to be of limited intelligence, considerably overweight, anxious, depressed and confused. She was ashamed of her new status in life as a result of her husband's inability to find work and was experiencing difficulties with him and her children. She was suffering from severe insomnia. Respondent's examination of Patient #1 was limited. He was satisfied with the medical work-up which had been conducted by his colleagues at the Dispensary. Because he was consulting psychiatrist for that facility, he knew all the physicians there and was familiar with the caliber of their work. Based on the medical information furnished him from the Dispensary and his own examination, he diagnosed Patient #1 as suffering a major depression and a psychogenic pain disorder manifested by headaches and insomnia. He developed a treatment plan for the patient which included a wide variety of psychotherapy interventions, the first of which was to effect relief of the symptoms. This included clarification of relationships, interpretation of dreams and fantasies, and allowed for catharsis. When Respondent found out that empathy and intervention alone would not work on this patient, and he had established a relationship with her, he started psychotropic medications including Elavil, the drug of choice for this type of condition in 1988. Elavil is a "superb" antidepressant. While the antidepressant factor is "cranking in", the medication also works as a sedative. For this reason, it is normally prescribed for administration at bedtime. Patient #1 responded to this course of treatment and she and the Respondent established a good and friendly working relationship, which he noted in his April 4, 1988 letter and treatment report to the Coast Guard and to CHAMPUS. In that treatment report, however, Respondent noted Patient #1 had a suicidal ideation. The term "suicidal ideation" does not import that the patient was, at that time, seriously considering suicide. Her mentioning suicide was but an overcompensation - more an alerting statement of depression and sadness with emptiness and angst. She never indicated to Respondent any thought of or plan to commit suicide. Patient #1 thrived for many months in Respondent's therapy. She complained often of her impoverished condition, however, and as a result, he wrote prescriptions for her in such a way that they could be filled at the Coast Guard dispensary without charge. This required writing prescriptions for more tablets of a drug at a lower strength which was stocked by the Dispensary. It was a surprise to him to learn, later on, that she was filling her prescriptions at Eckerds. Throughout the period he treated her, Dr. Fireman prescribed psychotropic drugs for Patient #1, which consisted primarily of amitriptyline, (Elavil), and butalbital, (Fiorinal), in varying strengths, and, at times, in compounds with other substances. As was noted previously, Elavil is an antidepressant with sedative effects. The recommended daily dose for a patient in an outpatient setting is indicated as 150 mg by the Physicians' Desk Reference, (PDR), which also recommends suicidal patients not be allowed unrestricted access to it because of the danger of intentional overdose. Other qualified psychiatrists who testified, including Dr. Spreyhe and Dr. El Yousef, indicate up to 300 or even 350 mg/day may be appropriate. As Dr. Spreyhe noted, it is not so much the daily dose on any given day which is pertinent but the aliquot over an extended period. In that regard, he notes, Dr. Fireman's prescriptions for both Elavil and Fiorinal were within recommended maximums and, therefore, within the appropriate standard of care. Fiorinal is a barbiturate anti-anxiety agent and muscle relaxant with habit forming potential. Fiorinal #3 contains codeine, a legend drug and narcotic. Generally, according to Dr. El Yousef, it should be dispensed for use at a rate of between 8 to 12 tablets per day over the short term, but over a 9 month period he would prescribe between 4 and 9 tablets per day. Pharmacy records indicate that over the period he treated patient #1, Respondent gave her numerous prescriptions for both Elavil and Fiorinal which, at first glance, appear to be excessive. For example, the records reflect that on December 29, 1987, Respondent wrote prescription number 390073 for 100 Elavil 25 mg tablets. Though the prescription clearly indicates no refills were authorized, and the back of the prescription form, where refills are noted by the pharmacist, fails to reflect any refills were authorized by the physician, the pharmacy records indicate two additional dispensings by the pharmacy for 100 tablets each on January 11 and April 20, 1988. There is no evidence to indicate how these additional fillings came about; who arranged for them, or who received them. On February 22, 1988, Respondent wrote prescription number 394289 to the patient for 12 Fiorinal #3 tablets. Again the prescription form authorizes no refills and the back of the prescription form indicates but one coordinated refill but the pharmacy records show the prescription was filled twice - once on April 6, 1988 and once on April 23, 1998. Only the latter is annotated. On March 3, 1988, Respondent wrote prescription number 397144 to the patient for 60 Fiorinal tablets. While the doctor's refill note reflects none were allowed, the computer printout sticker for the bottle reflects 2 refills were authorized. The back of the prescription form shows no refills annotated thereon as required, but the pharmacy's computer listing of all prescriptions indicates the prescription was refilled on May 28 and again on June 3, 1988. No further explanation is given. Prescription number 396378, written to the patient by Respondent on March 14, 1988 for 50 Fiorinal tablets, reflects no refills authorized by the physician nor does the reverse of the form bear any refill annotations. Nonetheless, the pharmacy records as shown on the computer printout indicates a refill on March 27 and April 6, 1988 with no explanation therefore. Before the last refill, however, Respondent wrote prescription number 397091 to the patient on March 29, 1988, for 21 Fiorinal #2, later approved for #3's. He also, on April 4, 1988, wrote prescription number 398853 for 35 Fiorinal tablets. Respondent claims he would not authorize a refill of a prior prescription for the same medication for which he is writing a new prescription, and, since neither of the refills of the earlier prescription properly reflect any physician authorization, it is so found. On May 2, 1988, Respondent wrote prescription 399717 for 50 Fiorinal tablets, and prescription 399718 for 100 Elavil 25 mg tablets. Both reflect Respondent's instruction that no refill be given, and neither form bears an annotation for authorized phone refills. Yet, the pharmacy's computer printout indicates that the prescription for Elavil was written on May 31, 1988 even though the bottle sticker shows it was filled on May 3, 1988. On August 1, 1988, Respondent wrote prescription 405572 for 100 Fiorinal and 475573 for 100 Elavil 100 mg tablets. Both were filled the next day but neither form bears any annotation of authorized refill, consistent with the physician's instructions. On August 16, 1988, Respondent prescribed another 100 Fiorinal by Prescription 406536. It was not refilled. On August 29, 1988, Respondent wrote prescription 407201 for 150 Elavil 50 mg tablets to patient #1, and number 407202 for 100 Fiorinal tablets. Both prescription forms clearly reflected no refills, but the back of the forms reflect refills were authorized. The Elavil prescription was refilled on September 10, 1988 by pharmacist Ivan Funkhouser who contends he refilled on the basis either of a call to or from the doctor's office. He cannot recall which. He also, at the same time, refilled the Fiorinal prescription under the same conditions. The Elavil prescription was filled again, this time for 225 tablets, on September 30, 1988, by pharmacist Robert Wivagg who also indicated phone refills made only on the basis of a call to or from the physician's office. In this case, however, he believes that because of the amounts involved, he would have spoken to the physician himself before filling the prescription. He cannot be sure of this, however, and Respondent denies having ever prescribed 225 Elavil tablets, regardless of strength, at one time. Mr. Lewis, the pharmacy expert, indicates that proper pharmacy practice would have allowed the pharmacist to issue fewer tablets than on the prescription but not more without express approval of the physician. The Fiorinal prescription, refilled on September 30, 1988, this time for 150 tablets, is not reflected on the prescription form though it is on the computer printout. Respondent denies that he ever called in prescriptions for Patient #1 because he never had to. She came to his office frequently enough that he was able to provide her with a new prescription for whatever medication she needed. Indeed, his medical office billing records reflect that in June, 1988 he saw her on June 6, 13, 20, and 27; in July, 1988 on July 5, 12, 19, and 26; and in August, 1988, on August 2, 9, 16, and 30. It would appear, therefore, that the refills of prescriptions reflected on the pharmacy computer printout either are in error or were arranged for under some unexplained process not involving Respondent. There appears to be no reason for him having had to authorize refills since he saw the patient so frequently, notwithstanding his comments to Ms. Sutton, during the investigation, that 90 percent of the refill calls are authorized by him personally, and only 10 percent through his secretary. There was no showing that the authorization comment Ms. Sutton recalls was related to this particular patient. Further, according to Ms. Maguire, Respondent's secretary, Respondent frequently refuses to grant refills, and, to her knowledge, he never gives refills to psychiatric patients. Since most, if not all Respondent's patients are psychiatric patients, this does not make sense. Respondent does not deny writing the two prescriptions on August 29, 1988. At that particular time patient #1 was planning a trip to New York to make peace with her dying mother. As a result, and since her headaches had gotten worse, as had her depression, he decided to increase her dosage of Elavil. This was a medical decision which is not in issue here. He admits that Elavil is a drug which is often used to commit suicide and that prescribed at even its lowest strength, a full prescription can be lethal. This became, therefore, an assessment problem wherein Respondent, the physician, had to evaluate the risk of the patient's depression against the benefits to be gained by the use of the drug. Respondent gave patient #1 enough Elavil to hold her through her visit up north. He had previously given her sixty 50 mg tablets to be taken 6 per day for a 300 mg dose at bedtime. He now told her not to use the 50 mg tablets any more and to destroy them. He believed she did. He then gave her a new prescription for one hundred and twenty 25 mg tablets for her trip. He unequivocally states that he never prescribes more than 300 mg/day of Elavil. He admits, however, that while she was on that dosage, he neither hospitalized her nor had blood work done on her. Respondent feels his original treatment plan and diagnosis were sufficient and his records pertaining to those factors were adequate. He uses checkoff forms because he believes they are the most open way of showing how he sees his patient and what he is doing for her. This same conclusion was reached by Dr. Spreyhe, another Board certified psychiatrist who is Clinical Professor of psychiatry at the University of South Florida Medical School, who has served as an expert witness for the Department in the past, and who continues to serve as a contract consultant for it and as a member of the Medical Advisory Committee of the Department. Examination of Respondent's medical records pertaining to Patient #1 indicates that the medical history and treatment plan are in the form of check sheets on which the physician makes no more than minimally worded entries. The Department's witness, Dr. Greener, an expert in the completeness of medical records, is of the opinion that Respondent's records should have reflected an initial detailed assessment of the patient's condition, including the reasons for her referral to him, a complete medical history, and a subsequent detailed mental status examination. This should be followed by a formulation of her problems and a treatment program. After the initial evaluation, according to Dr. Greener, the physician should make regular progress notes as to treatments, communications with others, phone calls received, prescriptions issued, and matters of that nature. This is done to memorialize the particulars for the patient and to keep a tally of which and how much of any drug is given to the patient. This would show over or under use as a possible flag as to how well the patient follows instructions or if the patient develops a use addiction problem. Based on Dr. Greener's review of Respondent's records for patient #1 and the prescription records relevant to her, he concluded those records were "totally inadequate." This conclusion is based on his opinion that the initial evaluation is cursory and without detail and there are few progress notes in the records. Those which are there are inadequate in detail and full of conclusions without the required supporting information such as drug side-effects, the patient's ability to follow instructions, follow-up, changes in dosages, and the like. He complains that Respondent's records do not really outline a plan of treatment designed specifically for that patient. For example, the forms used by Respondent are merely check-off forms even though, during the period, the patient was receiving continuing analgesic medications. From Respondent's records, it was impossible to determine how the patient was doing on the medications prescribed or whether additional medical evaluation was required. It is important to put this information in patient records to memorialize what is done and not just to keep the information in the treating physician's memory. Respondent denies that his initial evaluation and treatment plan, prepared by the use of form check sheets, is below standard. Dr. Spreyhe concluded the use of such check sheets is not inappropriate for the initial work-up of a patient and he opined that Respondent's forms, and the information thereon provide sufficient information for an independent understanding of the patient's situation and are within an appropriate standard of care. It is so found. However, the medical progress notes which make up the bulk of the remaining medical records are not so complete and, in Dr. Spreyhe's opinion are insufficient. Respondent concurs and admits this. It is so found. As to Respondent's prescribing practices, Dr. Greener is far more conservative than Respondent in prescribing Elavil. He starts with a low dose and gradually works up to a therapeutic level dosage depending upon the patient. He would start an average patient out at 25 mg/day and work up to a maintenance dose of 150 mg/day. Elavil is a dangerous drug and the doctor must closely monitor the patient for possible side effects and the direct effect it is having on the patient. It should never be ordered "prn", (as needed) when that designation relates to the amount to be taken. Based on Respondent's records for this patient, it would appear to Dr. Greener that the medication was being used improperly. There appears to have been no monitoring of the amount of the drug the patient was getting and it would appear that the patient was given the prerogative as to dose, which is not a good thing to do. In his opinion, a dose at 300 mg/day of Elavil is very and unnaturally high and he would not use so high a dose. He would do other tests first to see why the medication was not working at the lower dosage. As was seen before, however, other physicians of equal expertise disagree. Fiorinal is habit forming and, according to Dr. Greener, should be used only over the short term. If needed for a longer period, the patient should be reviewed to see why. The doctor must keep in mind the addictive properties of the drug. Here, Dr. Greener is of the opinion that Respondent prescribed excessive amounts of Fiorinal for patient #1. From January 27, 1988 through March 2, 1988, a period of 34 or 35 days, Respondent prescribed 302 tablets and Dr. Greener would be concerned that the patient was addicted. On March 21, 1988 Respondent prescribed another 50 tablets, and on March 27,1988, he prescribed 50 more followed by another 60 somewhat later and more after that. All of these were being prescribed for a patient whose records reflect she was doing "OK", and was "nicely stabilized". To Dr. Greener, this is just too much, especially for a patient who is obviously addicted and who appears to be taking the medication only to prevent withdrawal symptoms. By his prescription regimen, a patient would get no more than 10 tablets a day for no more than 4 to 5 days, and he would prescribe this drug for 9 months, as here, only with support for it in the patient records, including the opinions of other specialists to whom the patient would have been referred. While it is obvious Dr. Greener is more conservative in his approach to medication than is Respondent, the evidence does not clearly show Respondent's approach fell below standards. Dr. Spreyhe is of the opinion that the levels of Elavil and Fiorinal prescribed by Respondent for this patient were appropriate in both dosage and amounts. He has patients of his own who take such doses and he is not swayed by the PDR recommendations for dosage which, he believes, is too conservative. As for the Fiorinal, he would prescribe no more than 8 per day because there is some information that a patient may develop a tolerance for the substance. In any case, the drug is appropriate for the treatment of psychogenic headaches as were suffered by Respondent's patient here. Both W.L.P. and M.J.S. have been patients of Respondent. Both found him to be concerned and available. When patient #1 died, Ms. Sherman was in a therapy group with her. She did not appear to be suicidal and was looking forward to her proposed trip to New York. Patient #1 died on October 8, 1988. The report of the Hillsborough County Medical Examiner reflected her death as suicide from the combined effects of amitriptyline, (Elavil), butalbital, (Fiorinal), and salicylate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be issued herein, finding Respondent not guilty of all allegations except those relating to his failure to keep adequate medical records regarding Patient #1 as alleged in Count One, of which he is shown to be guilty, and imposing an administrative reprimand and a requirement for continuing medical education in the area of proper record keeping. RECOMMENDED this 31st day of August, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 31st day of August, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 93-5048 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 6. Accepted and incorporated herein. 7. Accepted as a restatement of witness testimony but not as a Finding of Fact. 8. Accepted as a restatement of witness testimony but not as a Finding of Fact. 9. & 10. Accepted that the medications were dispensed based on prescriptions written under the patient's name. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted as a restatement of witness testimony. - 18. Accepted and incorporated herein. Rejected as not a necessary conclusion to be drawn. Accepted. - 23. Accepted as restatements of witness testimony. Accepted and incorporated herein. - 26. Accepted and incorporated herein as pertaining to the dosage level of Elavil used and the balance accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted. & 32. Rejected as Findings of Fact, and found to be Conclusions of Law. FOR THE RESPONDENT: Accepted and incorporated herein. - 4. Accepted and incorporated herein. - 7. Accepted and incorporated herein. Accepted and incorporated herein. - 12. Accepted and incorporated herein. 13. & 14. Accepted. 15. & 16. Accepted and incorporated herein. 17. & 18. Accepted. 19. & 20. Accepted and incorporated herein. 21. Accepted. 22. This Proposed Finding of Fact is, in reality, a restatement of the evidence presented, in several subparagraphs, some of which are identified by letter and some of which are not. It is, however, accepted as an accurate restatement of the evidence admitted at hearing on this point, except where it becomes argument. 23. & 24. Accepted and incorporated herein. 25. First four sentences accepted and incorporated herein. Balance considered only as argument in support of the position taken. 26. Accepted and incorporated herein. 27. Accepted. 28. Rejected as a Conclusion of Law and not a Finding of Fact. 29. - 31. Accepted as basic findings. This does not go to their adequacy, however. 32. & 33. Rejected as contra to the weight of the evidence. & 35. Accepted as the substance of the witness' testimony. Accepted and incorporated herein. Accepted. Accepted. Rejected as a Conclusion of Law. COPIES FURNISHED: Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Suite 210 Tampa, Florida 33619 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue is whether respondent's license as a medical doctor should be disciplined for the reasons stated in the administrative complaint, as amended.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: At all times relevant hereto, respondent, Bernardo G. Bilang, was a licensed medical doctor having been issued license number 0026846 by petitioner, Department of Professional Regulation, Board of Medicine (DPR or Board). He has been licensed by the Board since July 19, 1976. Respondent presently practices medicine at 1201 South Highland Avenue, Suite 11, Clearwater, Florida. His specialty, if any, is not of record. Around 10:45 p.m. on February 2, 1986, N.K., a seventy-four year old female, was transported by ambulance to the emergency room of Morton F. Plant Hospital, Inc. (hospital) in Clearwater, Florida. When admitted, she complained of nausea, diarreah, dehydration, vomiting, fatigue and not feeling well. Also, she had experienced some pain in her back. With the exception of the back pain, which had begun more than a day earlier, all other symptoms had begun on February 2. Doctor Linda L. Shaffer was the emergency room physician on duty on the evening of February 2. Doctor Shaffer initially observed that the patient looked "acutely ill." She examined the patient and found her to be coherent and alert but very weak, as evidenced by her lack of grip strength In slurred speech, the patient answered questions very faintly and generally in one word answers. As might be expected, the patient was dehydrated. Her vital signs at 11:00 p.m. here as follows: rectal temperature - 104.6 degrees; blood pressure 152 over 96; respiration - 24; and pulse - 101. She also had tenderness across the middle of the back on both sides but did not have a stiff neck. After a preliminary physical examination and history were completed, and while the patient remained in the emergency room area for a few hours, Dr. Shaffer ordered a chest x-ray, electrocardiogram, complete blood count, electrolyte panel, chemical profile, two tests of kidney function, blood cultures, and urinalysis. The patient was then placed on a cardiac monitor, had a foley catheter inserted to obtain a urine speciman, and was given tylenol to reduce her temperature. Also, an IV was started. After finding the chest to be essentially clear and the abdominal examination negative, Dr. Shaffer diagnosed the patient as follows: "fever/dehydration - possible sepsis?" The latter diagnosis (sepsis) meant the patient may have had either a bacterial or viral infection in her blood stream affecting her entire system in a "generalized way." For a seventy-four year old patient, sepsis is a serious condition and can be life threatening if not promptly treated. The normal treatment for sepsis is antibiotics, fluids, medicines to elevate the blood pressure and reduce the temperature, and occasionally the use of steroids. It is noted, however, that a viral infection will not respond to antibiotics. If the use of antibiotics is indicated, they must be started immediately to kill the infection. After concluding her examination, Dr. Shaffer ruled out the threat of cardiac arrest and believed the patient, although "seriously ill," was not suffering from a terminal ailment. Nonetheless, she was concerned with the patient's low white blood cell count (3500) which was indicative of an infection, and one more likely of a viral nature. At the same time, she knew that influenza "was quite prevalent at the time" and might produce symptoms like those experienced by N.K. However, she stuck by her preliminary diagnosis of a possible bacterial infection. Respondent was on call the evening of February 2 for patients such as N.K. who were admitted to the hospital but had no personal physician. 1/ He was telephoned by Dr. Shaffer at 1:20 a.m. on February 3 concerning the patient's status. After being told the patient's symptoms, vital signs, available test results (which did not include the blood cultures, urine culture and chemistry profile) and Dr. Shaffer's preliminary diagnosis respondent requested Dr. Shaffer to admit N.K. to the hospital. He then gave telephonic orders to the nurse regarding N.K.'s future treatment. At that point, responsibility for the patient shifted to respondent. Respondent's first orders at 1:25 a.m. were (a) the patient be given nothing by mouth except medications (b) the IV be continued, (c) she be given atrophine and phenergaan intramuscularly if diarrhea occurred, (d) she be given compazine, if necessary, for nausea and vomiting, and (e) she continue to be given ten grains of tylenol every four hours for her fever. The patient was then transferred from a critical care room to a room where more stabilized patients are kept. According to a nurse on duty that evening, she did not consider N.K. to be a "problem" patient who required extra care or attention. It is noted here that the patient records reflect that respondent initially suspected that N.K. might have the flu, a fairly common ailment in the area at that time. At 1:40 a.m., the patient's vital signs were as follows: blood pressure 124 over 80; respiration rate - 24; and pulse - 92. There is no indication that her temperature was taken at that time but the records indicate that an hour earlier, it had droped to 103.1 degrees. At 2:25 a.m., the patient was moved from an emergency room bed to a semi-private room in the general ward. At 3:05 a.m., N.K.'s temperature was again checked and found to be 103.5 degrees. At 4:00 am., the patient's condition had begun to seriously deteriorate. She manifested signs of being "very lethargic," that is, it was difficult to awaken her, and she appeared to be weaker on her left side. According to Dr. Shaffer, such a localized weakness was indicative of "some process" involving the patient's brain and spinal cord. Also, N.K. still had a rectal temperature reading of 103.5 degrees. At 5:40 am., N.K.'s fingers and toes became cyanotic, that is, they turned blue in color, indicating a lack of circulation. Also, she was confused and her lethargy continued. By then, her respiration rate had increased to 32, almost twice the normal rate. Her blood pressure (138 over 70) began dropping which was a sign of sepsis shock, that is, the peripheral blood vessels were dilating causing the pressure to drop and circulation to be impaired. At 6:05 am., the head nurse, believing there to be an emergency situation, spoke with respondent by telephone. She relayed the previous findings from 5:40 a.m. and noted that the patient's temperature had risen to 104.7 degrees while her blood pressure had dropped to 126 over 70. The nurse did not recall whether she was able to reach respondent immediately or if it took a few minutes for him to return the call. In any event, respondent gave telephonic orders that mandol, a second generation antibiotic, be given to the patient intravenously every six hours, and she be given one gram of solu-cortef, a steroid medication, for shock. Also, he ordered an arterial blood gas analysis and that N.K. be given oxygen by nasal cannula when necessary. Although the telephonic orders were given at 6:05 a.m., the drugs had to be requested and obtained (after mixing) from the hospital pharmacy. In some cases, it takes several hours to receive a drug from the pharmacy, particularly during other than normal daytime hours. The steroid IV was eventually started at 6:30 a.m. but the mandol was never received and administered. When the patient's condition did not improve and actually continued to deteriorate, respondent was telephoned again by a nurse at 6:40 a.m. By then, the patient's entire skin had turned a bluish color indicating very poor circulation. After being briefed by the nurse, including the results of the just received blood gas report, but still without knowing the precise cause of N.K.'s ailment, Dr. Bilang issued a "CMO" order. This means "comfort measures only" and that no aggressive steps, such as resuscitative measures, be taken by hospital personnel to prolong the life of the patient. According to Dr. Shaffer, had resuscitative steps been taken at that time, the patient's chances for survival were around "twenty percent, maybe less." The patient expired at 7:13 a.m. The primary cause of death was listed as meningococcial meningitis, a bacterial infection having a 70% to 80% mortality rate, and a "quite uncommon" infection in a seventy-four year old patient. Laboratory results obtained several days after the patient's death revealed she had gram-negative sepsis. Doctor Bilang arrived at the hospital and pronounced the patient dead at 7:20 a.m. This was the first time respondent had seen and examined the patient. Respondent then dictated a history and physical examination which appear in the patient records. These reports were based on information previously provided by others. On February 21, 1986 respondent dictated a discharge summary which indicated a pre mortem physical finding. This report was also placed in the expired patient's records. Several months later, respondent prepared a second physical examination and history for the patient. This was dictated on July 31, 1986 and again was based on the notes of other persons. However, respondent made the following note at the beginning of the physical examination and history: "Disregard above notes. Patient expired prior to my seeing her in the ward." Two medical experts testified on behalf of the Board. They are Drs. Matthew M. Cohen and Laurence Neufeld, both board certified family practitioners in Tallahassee and Tampa, Florida, respectively. A Shreveport, Louisiana board certified internist, Dr. John M. Brady, presented expert testimony on behalf of respondent. In addition, Dr. Linda L. Shaffer, an experienced physician, testified from her perspective as an emergency room physician at the hospital in question. As might be expected, the experts reached differing conclusions regarding respondent's treatment of the patient. Pertinent findings based on the experts' relevant testimony are made below. There was a consensus among the experts that the emergency room doctor's role is to pass on to the admitting physician all the information the doctor has gathered from the examination and tests. It is then the responsibility of the admitting physician to ask the emergency room doctor appropriate questions concerning the patient, order vital signs to be taken at specified intervals, and give other directions to the monitoring staff (nurses) concerning steps to be taken in the event of changes in the patient's condition. The experts also concluded that the primary physician, in preparing a history and physical examination of the patient, should not rely on the emergency room doctor's notes and findings but should personally conduct his own physical and history in a more thorough manner. This is especially true when, as here, the emergency room physician is unable to conclusively establish the cause of the patient's illness. In Dr. Cohen's opinion, respondent should have suspected meningitis at the outset of N.K.'s admission. This was because of her lethargy, high fever and back pain, all being symptoms associated with that infection. Doctor Cohen also noted that respondent was cognizant of Dr. Shaffer's preliminary diagnosis of possible sepsis, knew that pneumonia and urinary tract infection were not the causes of the infection, and still had no idea what caused N.K.'s infection. Given these considerations, Dr. Cohen opined that respondent should have ordered further tests to confirm N.K.'s ailment, such as a lumbar puncture (spinal tap), an X-ray of her abdomen, a reexamination of the abdomen or a head scan. Doctor Cohen further suggested that after those tests were completed, it would have been prudent for respondent to "employ a sort of antibiotic recipe for dealing with a septic, elderly person." In other words, he should have used a group of intravenous antibiotics that would cover most of the possible causes for that type of infection. In addition to the foregoing omissions, Dr. Cohen was of the opinion that Dr. Bilang erred further when, after receiving advice from the nurse at 6:05 a.m. and 6:40 a.m. concerning the patient's rapid deterioration in health, he failed to institute aggressive antibiotic therapy and instead prescribed mandol, a drug Dr. Cohen felt was too little, too late. According to Dr. Cohen, respondent compounded his mistakes by issuing a CMO order when the patient did not have a terminal illness and without consulting the patient's family. By engaging in the foregoing conduct, the expert concluded that respondent did not conform with minimally acceptable medical standards in the community. Doctor Cohen next opined that it was inappropriate for respondent to prepare a history and physical after the patient's death and to base those items on information gathered by others. He labeled these matters "false and misleading" and a deviation from the standard expected of a doctor. Doctor Neufeld initially pointed out that respondent erred by failing to start a broad spectrum (third generation) antibiotic regimen when he assumed responsibility for the patient at 1:20 a.m. According to the witness, such a regimen was called for because respondent was aware of the patient's age, high fever, slurred speech, dehydrated condition, the very strong possibility of sepsis, and his own inability to promptly obtain blood cultures from the laboratory to aid in confirming or ruling out various ailments. Further, respondent had no concrete evidence that the patient was suffering from the flu, an illness he initially thought N.K. might have. Even if respondent was unsure if the infection was viral or bacterial, Dr. Neufeld pointed out that respondent nonetheless should have assumed the patient was septic and started an antibiotic regimen until the cultures were received from the laboratory or the fever subsided. Moreover, even if the patient had a viral infection, the antibiotics would not have harmed her. By respondent waiting until 6:05 a.m., and then ordering mandol rather than a stronger drug, Dr. Neufeld opined that respondent fell below the minimum standard of care for community physicians. Doctor Neufeld stated further that respondent deviated from the same standard of care by issuing a CMO order when the patient did not have a terminal illness. Doctor Neufeld echoed Dr. Cohen's sentiments that the prevailing community standards did not call for a CMO order unless the patient was afflicted with a terminal, irreversible illness and only after a physical examination had been performed by the physician. Doctor Neufeld found the physical examination documented by Dr. Bilang on pages 10 and 11 and the accompanying discharge summary on pages 13 and 14 of the patient records to misleading since both erroneously suggested a pre mortem physical finding. Also, Dr. Neufeld opined that the medical records did not justify the course of treatment to the patient. However, the basis for this opinion is not clearly delineated in the record. Doctor Neufeld conceded that though he would have gone to the hospital at 1:20 a.m. to examine the patient, respondent did not violate the standard of care by evaluating the needs of the patient by telephone. Even so, Dr. Neufeld maintained that respondent should have ordered antibiotics after his consultation with Dr. Shaffer. The expert differed in one respect with Dr. Cohen and agreed with respondent that the records, at least at 1:20 am., did not call for a spinal tap or head scan, and respondent's failure to perform those tests at that time was acceptable. Finally, although he acknowledged that an order for a third generation antibiotic regimen at 6:05 a.m. might not have been mixed and ready for patient use by the time the patient expired, Dr. Neufeld opined that respondent still had a duty to use all available measures to keep her alive until the drugs were received. According to Dr. Shaffer, she observed Dr. Bilang on a day to day basis and considered him a "caring, competent, practicing physician." However, she stated that respondent was sometimes too busy" and overextended" himself. As a consequence, she was "concerned" that he was taking care of too many patients at the same time. Although she did not consider herself qualified to render an opinion, she opined that respondent did not deviate from the minimally acceptable standards for Clearwater area physicians when he failed to initially order antibiotics for N.K. at 1:20 a.m. This was because, if a physician was unsure if a patient had a viral syndrome or a bacterial septic condition, he might wait "a little bit of time" to see what course of treatment was required. Further, the decision to order antibiotics is a "judgment call" by a doctor and depends in part on two "iffy" tests, a lumbar puncture and a gram stain of the blood smear. The latter test result was not available until several days after the patient expired. According to Dr. Brady, respondent's course of treatment and overall conduct, with one exception, fell within the minimal acceptable standards of care for physicians. The exception pertained to respondent's issuance of a CMO order. After reviewing the patient's records, Dr. Brady concluded that respondent could not have known the patient was suffering from a bacterial infection since nothing in the physical examination was suggestive of meningococcemia, the organism affecting the patient. Thus, he concluded that the patient's illness was probably not diagnosable until shortly before she died. This was because the patient did not have a stiff neck (nuchal rigidity), purplish skin rash, or signs of shock, which are the normal indications of meningitis, and because the infection is extremely rare and has an incidence rate of only one case per one hundred thousand persons in a given year. Even so, he conceded that if the disease occurs, its physical signs can manifest in a very short period of time and could have begun shortly after the patient was first examined by the emergency room physician around 11:00 p.m. Once respondent recognized the severity of the patient's ailment, and prescribed mandol at 6:05 a.m., Dr. Brady agreed that mandol would not have had any beneficial effect on the patient even if administered immediately after being ordered. Instead, the witness would have ordered a third generation antibiotic which is more effective in treating gram negative rods. While he characterized respondent's choice of mandol as "not the best thing to do", he nonetheless said "it was not an unreasonable thing to do" given the circumstances. The expert next agreed with the Board experts that a CMO order is appropriate only when the patient has a terminal illness and has requested that no life-sustaining measures be used. In this case, he agreed that the patient records did not justify this action. He added, however, that the patient would probably have expired no matter what resuscitative efforts were undertaken. Finally, while Dr. Brady did not think respondent was attempting to falsify his records by copying the notes of others in preparing the post-mortem physical and patient history, he noted that respondent should have indicated on his February 3, 1986 notes that he was copying the records of others. Having evaluated the testimony of the experts, the undersigned has resolved the conflicts in favor of the Board. Accordingly, it is found that respondent fell below the minimum standard of care by failing to initially recognize the patient's septic condition and prescribing a comprehensive antibiotic regimen, by failing to institute the same regimen at 6:05 a.m. after becoming aware of her critical condition, and by issuing a CMO order at 6:40 a.m. when the patient did not have a terminal illness. Further, respondent filed reports on February 3 and 21, 1986 which he knew or should have known were misleading and false, namely, a patient history, physical examination and discharge summary prepared post mortem which suggested that such reports were based on pre mortem findings by respondent. Finally, it is found that the records maintained by respondent were inadequate to justify the issuance of a CMO order since the patient did not have a terminal illness. By stipulation approved by Board order dated October 30, 1987, respondent was reprimanded by the Board, paid a $1,000 fine, was placed on monitored probation for a year, and agreed to take twenty hours of continuing medical education in the area of prescribing medicinal drugs. Official Board records indicate that respondent's license still remains on a probationary status presumably because of the pending proceeding.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of the violations discussed in the Conclusions of Law portion of this Recommended Order, and that respondent's medical license be suspended for two years. DONE and RECOMMENDED this 11th day of July, 1989, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of July, 1989.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I make the following relevant factual findings: During times material hereto, and particularly from January 1, 1983 through December 31, 1985, Respondent, Eusebio Subias, M.D., was a licensed medical doctor in Florida, board certified in Psychiatry and an eligible Medicaid provider of psychiatric services pursuant to the Medicaid contract he is party to with DHRS dated October, 1982. (Petitioner's Exhibit 1). Medicaid regulations and guidelines require physicians to meet board certification in psychiatry before they may provide reimbursable psychiatric services to Medicaid eligible recipients. As part of his agreement to participate in the Medicaid Program, Respondent agreed to keep such records as are necessary to fully disclose the extent of services provided to individuals receiving assistance in the state plan. Respondent also agreed to abide by the provisions of pertinent Florida administrative rules, statutes, policies, procedures and directives in the manual of the Florida Medicaid Program. (Petitioner's Exhibit 2). During 1986, the Surveillance & Utilization Review System unit of the Medicaid Office indicated that the amount of Respondent's medicaid billing greatly exceeded that of his peers. Based on that indication, the Office of Program Integrity asked Respondent to provide them with copies of certain medical records for the year 1982. Respondent provided the Department with those records as requested. (Petitioner's Composite Exhibit 3). Those records were forwarded to the peer review committee for evaluation. The records were reviewed by both the local and state peer review committees. The 1982 records contained inadequate information for the peer review committee to document or otherwise justify the number of office visits per patient. The records did not contain reasons for treatment, reasons for frequency of visits or what specific services were rendered to patients. (Petitioner's Exhibits 16 and 17, Pages 3 and 4 and Composite Exhibit 3). On April 21, 1986, Petitioner notified Respondent that it determined that he overbilled Medicaid in the amount of $17,820.09 for the calendar year 1982. Respondent was then notified that a similar review would be conducted for the period January 1, 1983 through December 31, 1985. That review and the results thereof are the subject of this proceeding. The Department subsequently requested, and Respondent provided medical records for 85 specific recipients which were selected by means of the "Disproportionate Stratified Random Sampling" (DSRS). (Petitioner's Exhibit 7). Respondent's 1983-85 records contain substantially more details than the records he provided Petitioner during the 1982 review period. Petitioner had its medical consultant, Dr. Forsthoefel, review the 1983-85 records. He was a member of the peer committee which made the peer review determination in 1982 which was used as a guide for the degree of overutilization. Forsthoefel denied those office visits that he determined were not supported by documentation in the medical records and concluded that the visits were not medically necessary. As a result, Petitioner sent Respondent a letter advising that he had overbilled medicaid in the amount of $79,093.05 for the years 1983-1985. (Petitioner's Exhibits 9 and 13). By letter dated September 5, 1986, Respondent requested a meeting to discuss the Department's proposed action and such a meeting was granted on October 31, 1986 at 1:30 p.m. Dr. Forsthoefel, Dr. Conn, Petitioner's Chief Medical Consultant in 1982, Millie Martin, and Respondent attended the October 31 meeting. During the meeting, Respondent attempted to individually review each of the approximately 3200 medical records for patients he treated during the years 1983-85 such that he could explain and document the medical necessity of each of the patient's office visits. He also requested that Petitioner have the records reviewed by a psychiatrist. Neither Dr. Conn nor Dr. Forsthoefel are psychiatrists. Dr. Conn left soon after the meeting began. Dr. Forsthoefel, unable and unwilling to comply with Respondent's request that each medical record be individually reviewed, concluded that continuing the meeting would not be productive and left after approximately 2 hours. The Department again denied those visits which it had early concluded were not medically necessary based on the review by its medical consultants. By letter dated November 10, 1986, Petitioner again advised Respondent that the Department would seek a $79,093.05 overpayment for the years 1983-85 and advised him of his rights to a formal hearing. Drs. Mutter and Tumarkin were commissioned by Petitioner to review the medical records under scrutiny with each doctor reviewing one half of the records. Based on their review, Respondent was denied reimbursement for even more office visits based on their opinion that the records did not contain sufficient documentation or notations that would indicate continued office visits were medically necessary. (Petitioner's Exhibits 17a and 18). Dr. Tumarkin made his comments on Respondent's medical records in green ink. Those records which did not contain green marking were records numbered 3 and 27 resulting in the Department's overstating the overpayment claim by $125.01. Respondent introduced information regarding Medicaid's denial of claims which should have been billed to Medicare. During the period from May 1985 through December 31, 1985, certain denials fall within the 1983-85 review period and since the Department never paid such claims, the Department agreed at hearing to reduce its overpayment amount by $6,421.44. Also at hearing, Petitioner determined that it made an error in its computation of the figures stated in the November 10, 1986 letter and was now seeking $78,661.93 minus $6,421.44 for the amount claimed to be overbilled by Respondent as $72,240.49. Respondent, who is of hispanic origin, treats a substantial number of Spanish speaking patients. Respondent graduated from medical school in Cuba at the age of 22 and participated in a rotating internship at Mercy Hospital in Hampton, Ohio. He came to Florida in 1963 and was licensed in 1964. In April, 1963, Respondent was employed at Hollywood Memorial Hospital. Respondent was the third Spanish speaking doctor to practice in South Florida and was the first to be promoted to a chairmanship at Hollywood Memorial Hospital. Respondent was the first clinical director at Coral Reef's Hospital. He is a member of several medical societies and was involved in the development of several psychotic drugs, including Elavil. Respondent is board certified in psychiatry. Respondent has staff privileges at Hollywood Memorial Hospital and three other area hospital. He has practiced psychiatry for more than 25 years in the United State and is accomplished in the treatment of severe psychotic patients. Respondent was tendered and received as an expert in psychiatry. Southeastern Florida was inundated during the early 1980's with mentally ill refugees during the Mariel Boat Lift. That area has a uniquely high need for psychiatric services due to its characteristic as a metropolitan area with a large homeless population. The Marlowe Study which was commissioned by Petitioner to review the need for psychiatric services in Dade County during the period which coincided with the Respondent's 1983-1985 office practice here under review, concluded that insufficient resources were earmarked for the treatment of mentally ill residents of Dade County, Florida. Respondent prefers to treat severely psychotic patients on an outpatient basis. He has been very successful in utilizing this method of treatment and it has resulted in substantial public benefit in the form of substantial financial savings that would have otherwise been required to hospitalize such patients for treatment. Respondent is paid $35.01 for a 45 minute session for each Medicaid patient whereas the average cost for inpatient treatment at an area hospital is approximately $400.00 per day. Respondent modified his record keeping practice in 1982 so that his medical records for 1983-85 contained the minimum requirements for medical records necessary to support Medicaid billings as specified in Rule 10C- 7.030(1)(m) and 10C-7.062(1(n) Florida Administrative Code. All of the medical experts testified that Respondent's records for the period at issue here met the minimum requirements specified in the required regulations and DHRS's procedure manuals. Those requirements are: dates of services; patients name and date of birth; name and title of person performing the service, when it is someone other than the billing practitioner; chief complaint on each visit; pertinent medical history; pertinent findings on examinations; medications administered or prescribed; description of treatment when applicable; recommendations for additional treatments or consultations; and tests and results. Petitioner presented testimony through Ms. Martin to the effect that Respondent had admitted during his October 1986 meeting with the medicaid consultants that he had, from memory, gone back and recreated his medical records for 1983-85. Respondent denied this at hearing and credibly testified that based on the deficiencies found in the latter part of 1982 concerning his medical records, he commenced to prepare a complete medical record for each patient visit. Respondent's testimony in this regard is credited and none of the medical professionals, save Ms. Martin, presented any evidence which would call into question the accuracy of Respondent's records during the period 1983- Ms. Martin's testimony to the contrary is rejected. Dr. Forsthoefel candidly admitted that he is not qualified to render an opinion with respect to medical necessity and appropriateness of specialized psychiatric services. Respondent is the first psychiatrist reviewed by the Medicaid officials of Petitioner for over-utilization as Petitioner's officials were unaware of any other psychiatrist who had been reviewed prior to Respondent. The peer review process for determination of over-utilization and mis- utilization of Medicaid services is designed so that the physician being reviewed may discuss individual patient records and cases with the Committee, as well as the Medicaid consultants who later apply peer review findings, and such discussion will be considered in arriving at a final determination. (Peer Review SOP, April, 1987, Respondent's Exhibit 12). An integral part of peer review for the physician being reviewed is to be able to discuss individual cases with the reviewer prior to a final determination being made concerning medical necessity and appropriateness. Such interplay and explanations regarding certain aspects of a case can lead to a more detailed determination concerning an overpayment issue. Respondent's October 1986 review should have been a complete new review of individual records affording him an opportunity to discuss specific cases with the physician consultants, provide him an opportunity to substantiate certain treatments based upon his recollection and justify the treatment modality he utilized for the 85 patients which comprised the random sampling. 2/ Respondent was not permitted to meaningfully discuss those individual cases even though he requested an opportunity to do so. This is so despite Petitioner's consultant's admission that such a consultation would have aided them and perhaps changed their opinion with respect to medical necessity and appropriateness of specific treatments rendered by Respondent. (Testimony of Conn, Forsthoefel, Tumarkin and Whiddon). While some experts would treat severely psychotic patients on a less frequent basis than Respondent and hospitalize them sooner, Respondent's method of treatment is well accepted among qualified board certified psychiatrists. Dr. Tumarkin's different treatment philosophy wherein he favored inpatient treatment for severely psychotic patients while Respondent showed a preference for outpatient treatment, is in no way indicative of inappropriateness by Respondent's method of treatment since his method was proven to be successful. Additionally, one expert, Dr. Tumarkin would have allowed more visits as being medically necessary and appropriate had he been advised by Petitioner's representatives that he should apply the community standard for medical necessity and appropriateness of psychiatric services. A Medicaid provider of psychiatric services is required to provide services equivalent to that of their peers. Had Dr. Tumarkin consulted with Respondent, his opinion concerning medical necessity and appropriateness would have been affected and he would have requested such had he known that he was allowed to. This is especially so based on the fact that his treatment preference is more hospital oriented. It is thus concluded that Respondent was not given a fair opportunity to present circumstances relevant to the overpayment amount in question here, despite his request to do so. (Petitioner's Exhibit 14). A review of a Peer Comparison Analysis with Respondent's practice respecting the number of office procedures per patient performed by him in contrast to other medicaid psychiatrists, indicates that Respondent saw his patients, on average, less than the average for other psychiatrists in Dade, Monroe and Broward Counties between the years 1983-85. (Petitioner's Exhibit 22). Dr. Stillman is board certified in psychiatry and has been practicing for more than 30 years. He reviewed, as Respondent's expert witness, all of the 85 patient charts in question. Dr. Mutter rendered a specific report about the even numbered charts that he reviewed. His reports indicates, with respect to many charts, that he was unable to find specific documentation supporting the reasons and medical necessity for treatment. This testimony was sharply contradicted by that of both Dr. Stillman and Respondent who easily located specific record documentation which indicated the medical necessity and reasons for services provided to patients by Respondent. Examples of over-utilization from Dr. Mutter's report were inquired about and on each occasion, Respondent and Dr. Stillman were able to identify documents not referred to by Dr. Mutter that substantiated the medical need and reasons for treatment. Drs. Subias and Stillman's testimony was not contradicted by Petitioner. Without going through each patient's records, a review of the findings concerning several patients is illustrative and will be herein discussed. Patient number 85, S. T., Jr. 3/ was a schizophrenic, suffering from epilepsy with borderline intellectual functioning. He was a very psychotic patient who was, during his early years, treated in an institution. (Petitioner's Composite Exhibit 5). He was obese, apprehensive, disoriented, suffered from impaired insight and judgment, a depressed mood, flat affect and a constant feeling of rejection. Respondent commenced treating patient number 85 twice weekly as an outpatient and as his condition improved, he was seen once a week and office visits were reduced further as his condition continued to improve. Without this intense continuity of treatment, patient number 85 would have decompensated and would have required an extensive institutionalization. Respondent provided substantial documentation as to the need for each of S. T.'s visits. Patient number 83, C. C., was a schizophrenic who suffered from depression, was delusional with a flat affect, poor reality contact and went through extended periods of depression on a monthly basis. Respondent prescribed benadryl to counteract patient C. C.'s delusional symptoms and otherwise justified his method of treatments, frequency and reason for each visit. Respondent substantiated that it was medically necessary to treat patient C. C. on each occasion where treatment was provided. Respondent's medical records provided the documentation for treatment in each instance. Patient number 81, F. D., was a schizophrenic who suffered severe mental depression. His condition had deteriorated to the point whereby family therapy sessions had to be scheduled by Respondent. Respondent was able to keep F. D. out of the hospital, he remained with his family and his condition improved to the point where the frequency of visits were reduced. Respondent's records justified the medical necessity and reasons for the treatment he provided patient F. D. Respondent testified as to his method of treatment as to patients 88, 78, 77, 52, 56, 48, 46, 38, 40, 60, 68 and as to each of those patients, Respondent's records document that the patients treatment and visits were medically necessary and appropriate. Dr. Stillman demonstrated that on each occasion, there was substantial record documentation which supported the necessity for the treatment as provided by Respondent. Based upon the inconsistent evidence presented by Petitioner respecting its claim that Respondent failed to document the medical necessity for the treatment he provided to the patients during the years 1983-85 and the direct evidence presented by Respondent which established that all of the services rendered by him to Medicaid recipients were medically necessary and appropriate under the circumstances, it is concluded that Petitioner failed to establish by a preponderance of the evidence that any of the treatments here in dispute were unnecessary, inappropriate or were not otherwise documented by the medical records under review. Moreover, all of the experts agree that the treating psychiatrist is best able to determine the medical necessity and appropriateness of specific treatments to render to a patient as that psychiatrist has direct contact with, and is best able to fully apply his or her training and experience. Respondent amply demonstrated that the services here at issue were medically necessary, appropriate and was of clear benefit to the patient. Petitioner has failed to meet its burden of establishing any basis for an overpayment as claimed. 4/
Recommendation Based on the foregoing Findings of- Fact and Conclusions of Law, it is RECOMMENDED that: The Department of Health and Rehabilitative Services enter a Final Order finding that there was no overpayment to Respondent during the years 1983- 85. Respondent is entitled to a refund of all monies held pursuant to the overpayment calculation by the Department in this cause together with 10% for annual interest pursuant to Rule 10C-7.060(12), Florida Administrative Code. DONE and ORDERED this 18th day of November, 1988, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 1988.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times pertinent to this proceeding, respondent Robb E. Ross was a licensed physician engaged in the practice of family medicine as a sole practitioner. He was licensed to practice medicine in the State of Florida in 1966 and holds license number 12433. He was board certified in family practice in 1970. Respondent also holds a license as a pharmacist. Respondent treated patient N.B. from September of 1970 through October of 1986. She initially presented as a new patient moving into the area, aged 61, for maintenance of her general physical medical care, primarily relating to her mild depression that she had for years following a mastectomy. While believing that patient N.B. had previously been under the care of a psychiatrist or psychologist, respondent never requested her prior medical records. Patient N.B. informed the respondent that she had been taking Biphetamine, a steroid amphetamine that is no longer produced, for the past ten years. Respondent continued patient N.B. in that treatment modality for over ten years, as well as treating her for other complaints. At some point, he did attempt to titrate her from Biphetamine, but she did not function as well with a substitute drug. When the drug Biphetamine was phased out of the market in either 1980 or 1982, respondent prescribed Dexedrine to patient N.B. and continued to do so approximately every six months. Respondent maintained her on Dexedrine due to her mild depression and the fact that she had been on amphetamines for many, many years. He was reluctant to take her off Dexedrine for fear that she could become overtly depressed. Since she did well with Dexedrine, respondent maintained her on that regiment due to the adverse side effects of other compounds utilized to control depression. The respondent's medical records for patient N.B. contain virtually no patient history or background information. For each patient visit, there is a brief notation which includes N.B.'s temperature, blood pressure and weight and also a reason for the visit. The reason noted on the records are either "check- up" or a brief statement of the patient's complaint on that particular day. The medication prescribed is noted, though very difficult to read. While the symptom or patient complaint is often noted, the patient records contain no statements of medical diagnosis, assessment or treatment plan. It is not possible to determine from N.B.'s medical records the reason that Dexedrine was prescribed for this patient. While N.B. complained of tiredness, she did not suffer from narcolepsy. Patient G.B. was under respondent's care from August of 1979 through May of 1985. He initially presented, at age 56, with problems relating to emphysema, lung collapse, exhaustion, impotency and aches and pains. Respondent prescribed various medications for him, including Nitroglycerin for chest pains. Respondent felt that due to his age and his complaints, patient G.B. had some type of arteriosclerosis. Patient G.B. frequently complained of being weak, exhausted and having no endurance or energy. For this reason, respondent prescribed Dexedrine for him on March 30, 1984. Other medications to increase his energy were tried before this and after this time. Nothing appeared to give him any relief. After determining that patient G.B. "liked his medicine too much," respondent terminated his treatment of him. The respondent's medical records for patient G.B. are brief and difficult to decipher. Again, the patient's temperature, blood pressure and weight are recorded for each visit, and there is a brief statement of the patient's complaint. There is no statement indicating a medical diagnosis or a treatment plan. The medications prescribed at each visit are written on the records, but are difficult to read. D.M. was a patient under respondent's care from December of 1976 until his death, at age 84, in March of 1986. He initially presented with stomach problems and subsequently had a host of other medical problems, surgeries and hospitalizations throughout the years. This patient was given so many different medications for his various physical problems that respondent did not always write each of them down on his records after each office visit. It appears from respondent's medical records that he first started patient D.M. on Dexedrine in January of 1984. At that time, D.M.'s chief complaint was "dizziness, falling, no pep." Respondent maintained D.M. on Dexedrine or an amphetamine type of compound from that period until his death, primarily because of his weakness, dizziness, falling down and low blood pressure. Other specialists were consulted regarding D.M.'s fainting and falling episodes, caused by postural hypotension, and were unable to remedy the problem. Respondent was of the opinion that the administration of Dexedrine enabled patient D.M. to function more properly and that it worked better than anything else. Patient D.M. expired in March of 1986. Respondent listed the cause of death as "cardiac arrest." The respondent's medical records on patient D.M. are typical of those previously described for patients N.B. and G.B. The office visit notes list patient complaints or symptoms and no medical diagnosis or comprehensive assessments. There are indications in the record that D.M. complained of chest pains in 1983, 1984 and 1985. The medications prescribed indicate the presence of cardiac disease. Respondent's record-keeping with regard to patients N.B., G.B. and D.M. are below an acceptable standard of care. They fail to include an adequate patient history and initial assessment of the patients. It is impossible to determine from these records what medicines the patients had taken in the past, what reactions they had to such medications, what medical procedures they had in the past or other important information regarding the patient's background. The respondent's only notation of treatment is a listing, and a partial listing in the case of D.M., of medications prescribed. His remaining notations are not acceptable to explain or justify the treatment program undertaken. Dextroamphedimine sulfate, also known as Dexedrine, is a sympathomimetic amine drug and is designated as a Schedule II controlled substance pursuant to Chapter 893, Florida Statutes. Commonly, it is referred to as "speed" or an "upper." It is addictive and highly abusive. While individual patients react differently to Dexedrine, its consumption can cause psychosis, marked elevations of blood pressure and marked rhythmic disturbances. As such, its use is contraindicated in patients with coronary disease. In addition, because Dexedrine is an "upper" and makes a patient "feel good," it can mask a true physical condition and prevent the patient from being treated for the physical ailment he is experiencing. A patient should not be relieved of pain without first knowing what is causing the pain. In Florida, Dexedrine may only be prescribed, administered or dispensed to treat specifically enumerated diseases, conditions or symptoms. Section 458.331(1)(cc), Florida Statutes. Neither respondent's medical records nor his testimony indicate that patients N.B., G.B. and/or D.M. suffered from the conditions, symptoms or diseases which warranted the statutorily approved and limited use of Dexedrine. Respondent was not aware that there were statutory limitations for the use of Dexedrine. He is aware of the possible dangers of amphetamines and he prescribes Dexedrine as a treatment of last resort when he believes it will help the patient. Respondent further testified that his medical record-keeping is adequate to enable him, as a sole practitioner, to treat his patients, though he admits that his medical records could be improved.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violating Section 458.331(I), subparagraphs (cc),(q),(t) and (n), Florida Statutes, and that the following penalties be imposed: an administrative fine in the total amount of $2,000.00, and probation for a period of twelve (12) months, with the following conditions: (a) that respondent complete continuing medical education courses or seminars in the areas of medical record-keeping and the dangers and authorized use of compounds designated as Schedule II controlled substances, and (b) that respondent submit to the Board on a monthly basis the medical records of those patients for whom a Schedule II controlled substance is prescribed or administered during the probationary period. Respectfully submitted and entered this 2nd day of September, 1987, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of September, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-3483 The proposed findings of fact submitted by counsel for the parties have been carefully considered. To the extent that the proposed factual findings are not included in this Recommended Order, they are rejected for the following reasons: Petitioner: The 48 proposed findings of fact submitted by the petitioner consist of summaries or recitations of the testimony of the witnesses presented by the petitioner in this proceeding. While the summaries and/or recitations constitute an accurate representation of the testimony received by those witnesses at the hearing, and are thus accepted, they do not constitute proper factual findings by themselves. Instead, they (along with the testimony presented by the respondent) form the basis for the findings of fact in this Recommended Order. Respondent: Page 4, Paragraph 1 The reference to 30 years is rejected as contrary to the evidence. COPIES FURNISHED: David E Bryant, Esquire Alpert, Josey, Grilli, Paris and Bryant 100 South Ashley Drive Suite 2000 Tampa, Florida 33602 David J. Wollinka, Esquire P. O. Box 3649 Holiday, Florida 33590 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joseph A. Sole, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
