STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )
)
Petitioner, )
)
vs. )
)
LEHEL KADOSA, M.D., )
)
Respondent. )
Case Nos. 05-0862PL
05-0863PL
)
RECOMMENDED ORDER
On August 15 through 19, 2005, an administrative hearing in this case was held in Tampa, Florida, before William F. Quattlebaum, Administrative Law Judge, Division of Administrative Hearings.
APPEARANCES
For Petitioner: Maura M. Bolivar, Esquire
Diane K. Kiesling, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Joseph Harrison, Esquire
Joseph Harrison, P.A.
2500 North Military Trail, Suite 490 Boca Raton, Florida 33431
STATEMENT OF THE ISSUES
The issues in the case are whether the allegations set forth in the Administrative Complaints filed by the Department of Health, Board of Medicine (Petitioner), against Lehel Kadosa,
(Respondent), are correct, and, if so, what penalty should be imposed.
PRELIMINARY STATEMENT
By an Administrative Complaint dated March 30, 2004 (DOAH Case No. 05-0863PL), the Petitioner alleges that the Respondent entered a guilty plea to a crime directly related to the practice of medicine and to the Respondent's ability to practice medicine.
By an Administrative Complaint dated November 22, 2004 (DOAH Case No. 05-0862PL), the Petitioner alleged that in eleven separate cases, the Respondent committed numerous violations of statutes and rules related to the Respondent's practice of medicine. The eleven separate cases are identified herein by case numbers assigned by the Department of Health (DOH). The Administrative Complaint combined the allegations of DOH Case Nos. 2003-09300, 2004-01840, 2004-20581, and 2004-26368, and the
findings of fact related to these cases are likewise combined in this Recommended Order.
The Respondent filed a request for formal hearing. The request was forwarded to the Division of Administrative Hearings, which consolidated the cases and scheduled the hearing for June 27 through July 1, 2005. Upon motion by the Respondent, the hearing was subsequently rescheduled to commence on August 15, 2005. The case was transferred to the undersigned
on August 8, 2005. A pre-hearing stipulation was filed on August 10, 2005.
During the proceeding, the Petitioner presented the testimony of 20 witnesses, including one by deposition. The Petitioner's Exhibits numbered 1 through 5, 6d, 7c, 8b, 8c, 8e, 10b, 14b, 16b-f, 17b-i, 18 through 23, 25 through 29, and 34 were admitted into evidence. The Respondent testified on his own behalf, presented the testimony of two witnesses, and had no exhibits admitted.
The eight-volume Transcript of the hearing was filed on September 30, 2005.
In response to a motion filed by the Respondent, the deadline for filing proposed recommended orders was extended to November 28, 2005. On that date, the Petitioner filed a Proposed Recommended Order. On December 7, 2005, the Respondent filed a motion seeking leave to file a proposed order by
3:40 p.m. on that date, but no proposed order was filed. On December 8, 2005, the Respondent filed an amended motion seeking leave to file a proposed order on that same date, but no proposed order was filed. On December 12, 2005, the Respondent filed a motion indicating that counsel was prepared to file the proposed recommended order, and then filed on that date a Proposed Recommended Order. The Proposed Recommended Orders
submitted by the parties have received due consideration in the preparation of this Recommended Order.
The statutory medication schedules referenced in this Recommended Order are set forth at Section 893.03, Florida Statutes (2001-2004).
FINDINGS OF FACT
The Petitioner is the State of Florida agency responsible for regulating the practice of medicine pursuant to Section 20.43, and Chapters 456 and 458, Florida Statutes (2001- 2004).
At all times material to this case, the Respondent was a Florida-licensed physician, holding license number ME 41277.
The Respondent's address of record is 7208 North Sterling Avenue, Tampa, Florida 33614-4051.
The Respondent is certified in occupational health by the American College of Occupational and Environmental Medicine. The Respondent is also certified in pain management by the American Academy of Pain Management, an organization not recognized by the American Board of Medical Specialties or the Department of Health, Board of Medicine.
At the hearing, the Petitioner presented the expert testimony of Kevin Chaitoff, M.D., on issues related to the relevant applicable standards of care. Dr. Chaitoff's persuasive testimony is credited without exception.
According to the testimony of Dr. Chaitoff, informed consent requires that a physician sufficiently educate a patient as to the risks, benefits, and alternatives to a proposed treatment to allow a patient to consider the information prior to signing an "informed consent" form. The patients appearing in the hearing testified that they were not provided with such information; accordingly, in each instance where a procedure was performed on a testifying patient, no informed consent was obtained.
According to the testimony of Dr. Chaitoff, sacroiliac injections and facet joint injections require use of fluoroscopy to assure proper location of the needle for delivery of the injected medication. Use of a fluoroscope can ensure proper placement of the injection, enhance efficacy, and minimize potential complications. Although the Respondent submitted billing claims indicating that he performed fluoroscopic imaging when administering injections, the evidence clearly establishes that he performed all injections referenced herein without fluoroscopy.
The Board of Medicine has established through administrative rule, standards of practice for treatment of pain. Dr Chaitoff testified without contradiction, that he is familiar with the rule, and that the Respondent failed to meet
the requirements of the rule specifically as to patients identified herein as B.T., S.H., F.T., H.Y., T.W., and O.G.
The Petitioner also presented the testimony of Jean Acevedo, an expert in medical coding and billing procedures. Ms. Acevedo's testimony was persuasive and is credited without exception.
Medicaid payments are calculated pursuant to "CPT Evaluation and Management" procedure codes. "Upcoding" is the practice of billing for services of a higher complexity than those actually provided to a patient. "Unbundling" is the practice of billing separately for the individual components of a comprehensive service normally billed as a single code. Upcoding and unbundling can result in payments to providers at higher levels than justified by the actual services delivered to the patients.
Ms. Acevedo testified that based on her review of the records, the Respondent submitted billing codes consistent with the practices of upcoding and unbundling. Some codes utilized by the Respondent in billing Medicaid were incorrect and indicated greater levels of services than those actually provided to the patient. The Respondent unbundled injection- related charges and billed separately for injections and supplies. Rather than billing for performing injections without imaging, the Respondent billed for performing injections using
fluoroscopy. The medical records lack documentation sufficient to support the billing codes submitted.
The Respondent testified that he relied upon a billing service to utilize the correct billing codes, and that the submission of inappropriate billing codes was the fault of the billing service.
The owner of the billing service testified that the codes on the "superbill" forms were selected by the Respondent, and that the Respondent provided the superbills to the billing service after they were completed. She further testified that if a superbill was submitted without codes, the form was returned to the Respondent for completion.
The contract between the billing service and the Respondent provided that the Respondent was responsible for providing accurate information on the superbills. Further, the physician is responsible for certifying that the submitted claims are correct.
The evidence establishes that the billing service owner contacted the Respondent at one time to question his use of the code indicating injection with fluoroscopy, and the Respondent indicated that he was aware that use of imaging equipment was required to support the submitted code.
The testimony of the billing service owner is supported by the evidence and is credited without exception.
DOAH Case No. 05-0862PL DOH Case No. 2002-14854
On April 5, 2002, B.T., a 41-year-old female, presented to the Respondent for treatment of pain related to a history of motor vehicle accidents and an injury from falling.
B.T. brought various medical records, including an MRI and related report, to the Respondent's office. According to the records, B.T. had a left lumbar hemilaminectomy at L5/S1 in 1993, and a cervical laminectomy with fusion in 2001. B.T. also suffered from a history of depression.
On B.T.'s first visit to the office, Respondent performed an examination without an assistant present in the examining room. The patient's vital signs were not taken.
During the examination, the Respondent touched the patient's spinal area in what she described as a "rough manner," which caused significant pain. The Respondent further manipulated the patient's neck without warning, at which time the patient began to cry from the pain. After having the patient lay on her back, he lifted her legs without warning, which caused additional pain.
The Respondent then instructed the patient to lie on her stomach at which time without warning he injected her back
with an unidentified substance. At the time of the injection, the Respondent was not wearing gloves, did not swab the injection site with alcohol, did not mark the injection site with a surgical pen, and did not use a fluoroscope to guide the injections.
Prior to the injections, the Respondent failed to discuss the procedure or discuss the risks and benefits of any treatment. The patient did not provide informed consent specifically related to the injections prior to the Respondent's administration of the medications.
The patient asked the contents of the injection, but the Respondent did not provide the information, other than to state that the injection would ease the pain. The medical records indicate that the injection contained Xylocaine and triamcinolone acetate.
On the same date, the Respondent ordered a complete set of cervical, thoracic, lumbosacral, and pelvic X-rays, and prescribed Soma and Vicodin to the patient.
Vicodin contains hydrocodone, a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
Soma contains carisoprodol, a Schedule IV controlled substance under Florida law. According to the applicable statute, a Schedule IV drug has a relatively low potential for abuse, but abuse can lead to limited psychological or physical dependence.
B.T. remained in pain during the week subsequent to her treatment by the Respondent. A lump developed at the injection site that was painful, hot, and swollen.
On April 15, 2002, B.T. again returned to the Respondent's office. Although a follow-up visit had been scheduled for April 19, B.T. sought treatment earlier because her pain was significant. During the visit, the Respondent indicated that her reaction to the injection was highly unusual and rare in his practice.
He referred the patient for physical therapy, and, although the patient resided in St. Petersburg, the Respondent directed her to see a Tampa facility across the street from his office. The patient questioned the value of therapy. During the conversation, the Respondent reviewed her medical records, and asked about previous neck surgery in a manner that, to the patient, indicated that the Respondent had not reviewed the medical history prior to initiating treatment.
B.T. continued to question the treatment plan, including the injection that she found to be ineffective at
addressing her pain. The Respondent continued to assert that the injections were beneficial to his patients, and thereafter administered an injection of an unidentified substance into her neck.
At the time of the injection, the Respondent was not wearing gloves, did not swab the injection site with alcohol, did not mark the injection site with a surgical pen, and did not use a fluoroscope to guide the injections. He failed to discuss the procedure or discuss the risks and benefits of the treatment. The patient did not provide informed consent specifically related to the injections prior to the Respondent's administration of the medications. The medical records indicate that the injection again contained Xylocaine and triamcinolone acetate.
The Respondent again ordered a complete set of cervical, thoracic, lumbosacral, and pelvic X-rays, and prescribed OxyContin to the patient.
OxyContin contains oxycodone, a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
As with the first injection, swollen painful lumps developed at the injection site.
On April 22, 2002, the patient returned to the Respondent's office for follow-up care, and brought various radiographic studies for the Respondent to review. During the review, the Respondent again asked about the previous neck surgery, in a manner that, to the patient, suggested a lack of awareness on the Respondent's part, notwithstanding their previous discussion and the medical history she provided upon initially seeking treatment.
During the April 22 visit, the Respondent again administered injections in the mid-back and "tailbone" area. The patient testified that she felt the needle scraping against bone. The contents of the injections were not disclosed. The Respondent did not wear gloves, did not mark the injection site with a surgical pen, and did not use a fluoroscope to guide the injections. The medical records indicate that the injection again contained Xylocaine and triamcinolone acetate.
A nerve conduction test was ordered on April 22 and was performed in the Respondent's office on May 1, 2002.
The patient returned for follow-up care on May 6, 2002, and advised the Respondent that her pain had worsened since he began treating her, an opinion with which the Respondent disagreed. He observed that she had reported
headaches (an ailment that had been previously reported to the Respondent) and thereafter injected a substance into her temple and into her shoulder. The patient testified that she again felt the needle scraping against bone. The medical records indicate that the injection contained Xylocaine and triamcinolone acetate.
Upon leaving the Respondent's examination room, the patient was in pain of such significance that she had difficulty walking and requested the assistance of a male companion who had accompanied her to the Respondent's office and was waiting outside. When her companion responded to assist her, the Respondent engaged in a verbal altercation initially with the companion, and then with both the patient and the companion, in the presence of other patients.
The Respondent subsequently called the patient and threatened to discontinue treatment, but relented when the patient agreed not to bring the companion back into the Respondent's office again. The patient had little option but to comply with the Respondent's directive because he was the only authorized Medicaid-approved pain management physician in the area from whom she could seek treatment.
On May 13, 2002, the patient returned to the Respondent's office for follow-up care at which time she was informed that an additional nerve conduction test was required
and that the process would take four hours to complete. The patient asked to reschedule the test because she did not have sufficient time to complete the test on that date, at which point the Respondent refused to refill the patient's medications. Another verbal altercation erupted between the Respondent and the patient, and the Respondent called law enforcement officials to remove the patient (and her companion who was waiting outside the office) from the Respondent's property. The altercation occurred in the presence of other patients.
The treatment plan implemented by the Respondent was ineffective and inappropriate based on the information presented. The Respondent diagnosed the patient with lumbago, lumbar spondylosis, sacroiliac arthropathy, ligamentous and tendon instability, facet syndrome, greater occipital neuralgia, and sprain strain. A more appropriate diagnosis based on the MRI studies would have been L4/L5 disk herniation and L2-L4 annular disk tears, and treatment consistent with the patient's symptoms, history, and radiological studies would have included epidural steroid injections, transformational injections, intradiscal procedure, and physical therapy.
According to the testimony of Dr. Chaitoff, the treatment provided by the Respondent to B.T. was below the applicable standard of care in that the Respondent: failed to
obtain or document informed consent prior to administering injections; failed to discontinue injections when they did not provide the expected pain relief; prescribed medications that could have contributed to an adverse effect, including inflammation at the injection sites; ignored the adverse impacts apparent at the injection sites; failed to document the effectiveness of the treatment plan; ordered and/or performed unnecessary radiographic studies; failed to document and explain the rationale for the pharmacological content of the injections; failed to address the lack of efficacy of the treatment plan; failed, when his treatment plan was unsuccessful, to refer the patient to a pain management specialist skilled in use of fluoroscopy and in performing epidural injections, transformational injections, and intradiscal procedures; and acted unprofessionally towards B.T. by failing to respond to questions and engaging in conflicts in the presence of other patients.
Some of the codes utilized by the Respondent in billing Medicaid for the services provided to B.T. were incorrect and indicated greater levels of services than those actually provided to the patient, resulting in payments at a higher rate than justified by the services the patient received. The Respondent also billed for performing injections using fluoroscopy, when he did not use fluoroscopy.
DOH Case No. 2002-19119
On April 24, 2002, S.H., a 41-year-old female, presented to the Respondent for treatment of pain related to a 1992 work accident and 1995 cervical surgery.
According to medical records, S.H. complained of neck and back pain, and headaches, and had sought prior treatment from other physicians. Her medication intake was identified as Lortab, Klonopin, Flexeril, Albuterol, Arthrotec, and Pepcid AC. Her social history indicated that her father was alcoholic and that a brother had committed suicide by shooting himself. Her past medical history referenced depression without further information.
The records indicate that beginning on April 24, 2002, and on five additional office visits ending on July 17, 2002, the Respondent administered injections without fluoroscopy to
S.H. There is no documentation of informed consent by the patient.
On April 24, 2002, the Respondent prescribed Lortab and Soma to the patient.
Lortab contains hydrocodone, a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the
substance may lead to severe psychological or physical dependence.
Soma contains carisoprodol, a Schedule IV controlled substance under Florida law. According to the applicable statute, a Schedule IV drug has a relatively low potential for abuse, but abuse can lead to limited psychological or physical dependence.
The treatment provided to the patient by the Respondent was ineffective. By the last visit on July 17, the records indicate that the patient complained that her pain had increased by 80-90 percent since beginning treatment.
The medical records fail to indicate that the Respondent reviewed the patient's previous medical treatment or records. Other than a musculoskeletal examination, the records do not document any further medical review.
The medical records fail to indicate that the Respondent considered the patient's history of depression or other social factors prior to prescribing controlled substances to S.H.
S.H. died in October 2004 of a drug overdose.
According to the autopsy report, the death was identified as a suicide due to a multiple drug overdose. The results of a drug screen indicated the presence of numerous substances, including carisoprodol and oxycodone.
According to the testimony of Dr. Chaitoff, the treatment provided by the Respondent to S.H. was below the applicable standard of care in that the Respondent: failed to review past medical history or to document an appropriate physical examination; failed to document the effectiveness of the treatment plan; failed to obtain or document informed consent prior to administering injections; continued to perform injections without fluoroscopy when the treatment failed to provide the expected pain relief; and failed to consider the patient's social history prior to prescribing controlled substances.
The Respondent billed Medicaid for services not provided to S.H., specifically using codes indicating that he performed injections with fluoroscopy. Additionally the evidence establishes that he "upcoded" by billing with codes that reflected a more extensive medical evaluation than was actually performed.
DOH Case No. 2002-22078
In August 2002, an adult male identified as T.V. (also known as T.S.) presented to the Respondent for treatment of pain after being referred by a previous pain management specialist.
Prior to being called in to meet with the Respondent,
T.V. sat in the waiting room. A large dog wandered around the reception area. T.V. observed the Respondent entering the
waiting room to call for various other patients. T.V. testified that on each observation, he observed the Respondent wearing stained gloves. When the Respondent called T.V. from the waiting room, the patient observed the Respondent wearing the same stained gloves.
T.V. was not taken into an examination room, but instead was escorted into a room he described as an office, wherein T.V. observed the Respondent drinking coffee and handling paperwork while wearing the same stained gloves.
The Respondent performed a minimal examination on T.V., during which the Respondent, wearing the same gloves, touched T.V. No vital signs were taken. The Respondent did not review the medical history information with T.V. The Respondent discussed giving injections to T.V., but did not identify the contents of the injections. T.V., concerned about the gloves and potential contamination issues, declined the injections, and left the office. T.V. did not return to the Respondent for treatment.
DOH Case No. 2003-04569
In early February 2003, P.R., a 45-year-old female, presented to the Respondent for treatment of pain, including migraine headaches, and neck and back pain.
She arrived at the Respondent's office with radiological studies for the Respondent to review.
Prior to seeing the Respondent for examination, a nurse called P.R. from the waiting area and a series of X-rays were completed.
When the Respondent met with P.R., he performed no physical examination. There is no documentation that the Respondent reviewed the radiological studies brought by the patient or the X-rays taken in the Respondent's office.
The Respondent apparently told P.R. that he did not believe her assertions of pain and directed her to leave his office.
The Respondent billed the payor for a detailed and complex medical examination; however, the medical records fail to reflect that such an examination occurred, and the billing appears to be an instance of upcoding.
DOH Case No. 2004-24823
From December 2003 through May 2004, the Respondent treated F.T., a 42-year-old female, for pain. At various times,
F.T. has been diagnosed with lumbago, sciatica, lumbar spondylosis with myelopathy, and lumbar instability.
According to medical records, on December 29, 2003, the Respondent administered injections of Xylocaine, Marcaine, triamcinolone acetate, and "Proliferative Solution" to F.T. There is no record of a physical examination. The patient's vital signs were not taken. There was no discussion of
potential risks attendant to the injections. The Respondent did not use a fluoroscope and did not mark the injection sites with a surgical pen.
According to medical records, on January 26, February 5, and February 18, 2004, the Respondent administered injections of Xylocaine, Marcaine, and "Proliferative Solution" to F.T. There is no record of any physical examination being performed. The Respondent did not use a fluoroscope in administering the injections and did not mark the injection
sites with a surgical pen. No discussion of any potential risks attendant to the injections occurred on any visit.
Also on February 18, 2004, the Respondent prescribed Lortab and oxycodone to F.T. He provided a script for
120 tablets of Lortab (10/500 mg) and 480 tablets of oxycodone (5 mg) to the patient.
Lortab contains hydrocodone. Both hydrocodone and oxycodone are Schedule II controlled substances under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
Although the records indicate that F.T. kept an appointment with the Respondent on March 9, 2004, there is no record of any examination or treatment provided on this date.
On March 18, 2004, F.T. arrived at the Respondent's office to find it essentially empty of patients and most employees. The patient testified that she was advised by a physical therapist that the Respondent had fired the employees and had left the office. The medical records indicate that on that date, the patient's prescriptions were renewed in the same quantities as on February 18, 2004. The medical record contains a stamped identification of "Dr. Alan T. Braunstein, M.D." A handwritten note on the medical record indicates that a reduction in medication was being considered.
The patient testified that on the evening of March 18, 2004, the Respondent contacted her and offered her employment in his office. On March 19, 2004, F.T. arrived for work and met another new employee named "Heidi." F.T. handled front desk duties at the Respondent's office, including verifying insurance coverage and accepting co-payments from patients.
F.T. continued to see Respondent for pain treatment while working in his office. She continued to receive injections from the Respondent. There are no records of physical examination related to these visits. According to the medical record, pain relief was inconsistent indicating that the treatment was not successful.
She received additional pain medication prescriptions while employed by the Respondent; however, she testified that
she did not take the medication at work and was not affected by medication while at work.
On April 5, 2004, the patient received a prescription for another 120 tablets of Lortab (10/500 mg), apparently from Dr. Braunstein.
On April 16, 2004, the patient received a prescription for 120 tablets of OxyContin (20 mg). OxyContin contains oxycodone, a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
On April 27, 2004, the patient received a prescription for 90 tablets of OxyContin (40 mg).
On May 11, 2004, the Respondent administered injections of Xylocaine, Marcaine, and Proliferative Solution to
F.T. An employee named Kelly Cusick prepared the injections.
Ms. Cusick testified at the hearing that she was a licensed X-ray technician who was employed by the Respondent for a few months. Although she had no relevant training, she acknowledged that she prepared syringes for injection pursuant to the Respondent's direction.
The injections administered by the Respondent to F.T. on May 11, 2004, resulted in pain and swelling at the injection
site on F.T.'s back. On May 12, she called the Respondent about the pain. She testified that she was advised to apply ice and take her medications.
By May 13, 2004, the swelling had increased substantially and she went to the Respondent's office. She was taken into the examination room where other employees were present. The Respondent instructed F.T. to get onto an examining table, she complied, and then the Respondent pulled down her pants exposing her buttocks. He manipulated the swollen area and caused additional pain, causing F.T. to begin crying.
During the time F.T. was on the examination table with other employees present, the Respondent made derogatory remarks about the patient's weight, and slapped her bare buttock. Before F.T. left the office, the Respondent provided F.T. with a prescription for 120 tablets of Lortab (10/500 mg) and 30 Oxy-IR (5 mg).
Oxy-IR contains oxycodone, a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
F.T. stopped working for the Respondent on May 17, 2004.
The medical records fail to justify the diagnoses and treatments provided to F.T. Additionally, the records fail to justify the quantity of pain medication prescribed to the patient.
According to the testimony of Dr. Chaitoff, the treatment provided by the Respondent to F.T. was below the applicable standard of care in that the Respondent: failed to perform an adequate physical examination of the patient; failed to substantiate his diagnosis on the records; failed to obtain informed consent for the injections; continued to perform injections without fluoroscopy when the treatment failed to provide the expected pain relief and resulted in negative side effects; failed to document the effectiveness of the treatment plan, including injections and medications; failed to moderate the quantity of controlled substances being prescribed; and failed to act professionally towards F.T. as his patient.
None of the injections administered to F.T. were performed using fluoroscopy; however, the Respondent "upcoded" the procedure and submitted billing codes for injections with fluoroscopy.
DOH Case No. 2004-28040
Patient H.Y.
On April 2, 2004, H.Y., a 47-year-old male, presented to the Respondent for treatment of pain related to auto accidents in 1992 and 2002.
According to the medical records, H.Y. complained of pain in his right knee and hand, neck, lower back, and legs. The patient's current medications were listed as Percocet,
MS Contin, Xanax, Neurontin, and Valium. He had high blood pressure and was taking Metaprolo [sic] (100 mg) four times daily. He reported a history of anxiety, depression, and insomnia.
The Respondent completed a spinal and neurological evaluation, and diagnosed the patient with pain, facet joint syndrome, post-laminectomy syndrome, lumbosacral instability, sacroilitis [sic], TM-joint arthalgia [sic], unspecified anxiety, and depression.
The Respondent treated the patient by prescribing
270 tablets of Methadone (10 mg) and 120 tablets of Xanax (1 mg).
Methadone is a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to
the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
Xanax contains alprazolam, a Schedule IV controlled substance under Florida law. According to the applicable statute, a Schedule IV drug has a relatively low potential for abuse, but abuse can lead to limited psychological or physical dependence.
The medical records contain a note from the Respondent that he had warned the patient to use the medication under supervision; however, nothing in the patient's files indicates any acknowledgement or understanding of the warning by the patient.
Methadone can cause electro-physiological changes and can result in dysrhythmia. The Respondent did not perform a baseline EKG prior to prescribing the Methadone.
There is no credible evidence that the Respondent exercised appropriate caution, considering the medication usage identified by H.Y., in prescribing Methadone and in issuing an additional Xanax prescription to the patient. There is no evidence that the Respondent reviewed prior medical or pharmacy records related to the patient. The Respondent did not order that a drug screen be performed. The records contain no evidence of a narcotics agreement between the patient and the Respondent. The quantities of medication prescribed by the
Respondent to H.Y. were excessive. Beyond the warning noted in the records, there is no credible evidence that the Respondent exercised appropriate diligence in prescribing medication to the patient.
On April 5, 2004, H.Y. was found dead at the home he shared with his mother. According to the medical examiner's report, the cause of death was accidental intoxication by the combined effects of Methadone and alprazolam.
According to a police report, prescription containers were located for both drugs indicating a fill date of April 2, 2004. Only 215 of the 270 Methadone tablets prescribed by the Respondent remained. Only 73 of the 120 Xanax tablets prescribed by the Respondent remained.
According to the testimony of Dr. Chaitoff, the treatment provided by the Respondent to H.Y. was below the applicable standard of care in that the Respondent: failed to perform a physical examination; failed to substantiate the diagnosis; failed to obtain or review prior medical and pharmacy records; failed to utilize a narcotics agreement; failed to appropriately moderate the controlled substances prescribed; and failed to maintain accurate and complete medical records.
Patient T.W.
On April 30, 2004, T.W., a 43-year-old male, presented to the Respondent for treatment of pain in his jaw and back, and headaches.
According to the medical records, the patient's current medications included Percocet, Lortab, OxyContin,
MS Contin, and Methadone. A history of asthma, high blood pressure, rheumatoid arthritis, and hepatitis C were noted in the records.
The Respondent completed a spinal and neurological evaluation, and diagnosed the patient with pain, facet joint syndrome, herniated disc with reticulates, lumbosacral instability, paresthesia, sacrum pain, chronic pain syndrome, neuralgia, migraine headaches, TM-joint arthalgia [sic], muscle spasm, and myofascitis.
The Respondent treated the patient by prescribing
60 tablets of Valium (10 mg), 120 tablets of Methadone (10 mg), and 90 tablets of Percocet (7.5/500 mg).
Valium contains diazepam, a Schedule IV controlled substance under Florida law. According to the applicable statute, a Schedule IV drug has a relatively low potential for abuse, but abuse can lead to limited psychological or physical dependence.
Methadone is a Schedule II controlled substance under Florida law. Percocet contains oxycodone, a Schedule II controlled substance under Florida law. A Schedule II drug has a high potential for abuse and an accepted, severely restricted, medical use. According to the applicable statute, abuse of the substance may lead to severe psychological or physical dependence.
The medical records contain no evidence that the Respondent discussed appropriate use of the prescribed medications with the patient. There is no evidence that the Respondent reviewed prior medical or pharmacy records related to the patient. The Respondent did not order that a drug screen be performed. The records contain no evidence of a narcotics agreement between the patient and the Respondent.
Pharmacy information indicates that the Methadone and Percocet prescriptions were filled on April 30, 2004. The Valium prescription was filled on May 1, 2004, for a quantity of
20 tablets, rather than the prescribed 60.
On May 11, 2004, T.W. was found dead. According to the medical examiner's report, the cause of death was accidental intoxication by Methadone and cocaine.
According to the testimony of Dr. Chaitoff, the treatment provided by the Respondent to T.W. was below the applicable standard of care in that the Respondent: failed to
perform a physical examination; failed to substantiate the diagnosis; failed to obtain or review prior medical and pharmacy records; failed to utilize a narcotics agreement; failed to appropriately moderate the controlled substances prescribed; and failed to maintain accurate and complete medical records.
DOH Case No. 2004-36251
At some point prior to April 30, 2004, the Florida Attorney General's Office, Medicaid Fraud Unit, initiated an investigation of the Respondent. A part of the investigation included utilization of a female undercover operative using a fictitious name ("O.G.") who was sent into the Respondent's practice as a patient attempting to obtain medication.
The undercover operative recorded her interactions with the Respondent on audiotape, some of which were transcribed. Both the audio records and the transcriptions were admitted into evidence at the hearing. The undercover operative testified about her visits with the Respondent. Any inconsistency in chronology between the testimony and the exhibits has been resolved by reference to the audio records and related transcriptions.
On April 30, 2004, the undercover investigator presented to the Respondent for treatment of headaches and directly asked for a prescription for Vicodin. The Respondent
declined, stating that he was not a "dope dealer" and had to know more about the nature of the headaches.
The investigator stated that she had been taking Vicodin for several years, had moved to Florida from New York, where Vicodin was supposedly easy to obtain, and was having difficulty locating a new resource for the medication since the move. She told the Respondent that she began taking it recreationally with a boyfriend, and that her headaches began when she stopped taking the medication. She also stated that she had been taking Xanax. Upon inquiry by the Respondent, the investigator stated that someone named "Michele" who was otherwise unidentified referred her to the Respondent's practice.
The Respondent took her blood pressure and manipulated her limbs apparently to determine whether any other pain sources were present; however, the investigator denied any pain but for the headache.
According to the medical records, the Respondent diagnosed the investigator with neuralgia, migraine headache, muscle spasm, and myofascitis.
On April 30, 2004 the Respondent prescribed Vicodin (10 mg) and Xanax (0.5 mg). The medical records contain a narcotics agreement signed on that date by the investigator and the Respondent. The investigator testified that she signed all
the papers presented to her before being allowed to meet the Respondent. According to the pain management plan dated April 30, 2004, the investigator was directed to return in two weeks. The investigator paid for the office visit in cash.
In mid-May 2004, the investigator returned to the Respondent's practice. According to the audiotape, the date of the visit was May 17, 2004. The medical records indicate that the date was May 18, 2004. In any event, the Respondent and the investigator discussed the fact that the investigator was seeking refills on the medication. He offered to administer injections, and the investigator declined; nonetheless, the medical records reflect documentation for administration of the injections.
The Respondent asked additional questions about "Michele" and mentioned that the investigator is a cash-paying patient. The Respondent provided refill prescriptions for increased quantities of the medications, and told the investigator to return in one month. The investigator paid for the office visit in cash.
On June 4, 2004, the investigator returned to the Respondent's practice and met with him. The Respondent again asked questions about "Michele." He again offered injections, and the investigator declined.
The investigator told the Respondent that the Vicodin was not working because she had developed a tolerance for it, and that she needed "something better." The Respondent offered a prescription for Methadone (10 mg) taken four times daily and a prescription for Phenergan for nausea.
The Respondent also asked the investigator whether she would be interested in participating in a treatment program to assist in withdrawal from the medication. She advised him that she would talk about it with him on her next visit. He advised the investigator that the Methadone would not make her "high" and that it would stop her desire to take pain medication. He discussed the strength of Methadone and advised her as to appropriate use.
On June 4, 2005, the Respondent prescribed Methadone (10 mg) and Phenergan (25 mg). The investigator paid for the office visit in cash.
On July 7, 2004, the investigator returned to the Respondent's practice seeking medication prescription refills. While meeting with the Respondent, the investigator offered to refer another headache patient to the Respondent if he would waive his office visit charges, and he agreed to do so, but he cautioned that the referred patient must need treatment of a medical condition, stating, "I am not a dope dealer." The
investigator left the Respondent's practice with refills for Methadone and Xanax, and paid for the visit in cash.
Although the Respondent clearly expressed concern about the quantity of narcotics supposedly being used by the investigator, he did not order a drug screen at any point during his treatment of the patient. The Respondent failed to moderate the controlled substances prescribed to the investigator.
On October 15, 2004, law enforcement officials conducted a search of the Respondent's office pursuant to a search warrant. During the search, the officials discovered prescriptions that were pre-written and pre-signed for various narcotics, including Percocet, OxyContin, Vicodin, Dilaudid, Soma, and Methadone. The prescriptions were blank where the names of patients were to be written.
DOH Case Nos. 2003-09300, 2004-01840, 2004-20581, and 2004-26368
In September 2003, the Respondent employed a female identified as T.R. Shortly before beginning the employment,
T.R. suffered a fractured foot that was placed in a "boot" for stabilization.
After starting to work for the Respondent, he advised
T.R. that the boot was insufficient, and he placed a cast on her foot. The Respondent reviewed no X-rays and performed no examination prior to placing the cast on her foot.
A few days after the cast was set, T.R.'s foot became swollen and painful. She contacted the Respondent, who met T.R. at his office and cut the cast from her foot. At one point in removing the cast, T.R. complained that the Respondent was cutting her foot.
After removal of the cast, it was obvious that T.R.'s toe had been cut. The Respondent handed T.R. a pill that she identified as OxyContin and told her to take it. At the same time, the Respondent took a pill that resembled the pill given to T.R.
On several other occasions, the Respondent provided various pills, including Vicodin, to T.R.
At no time did the Respondent document the treatment or medication provided to T.R.
According to the testimony of Dr. Chaitoff, the treatment provided by the Respondent to T.R. was below the applicable standard of care in that the Respondent: failed to perform a physical examination; failed to make a diagnosis; failed to properly treat the foot injury; failed to properly remove the cast placed on T.R.'s foot; failed to maintain accurate and complete medical records; and failed to make a record of prescribing controlled substances.
The Respondent employed unlicensed persons to provide certain services, including massage services. T.R. provided
massage therapy to patients no more than ten times at the direction of the Respondent.
Male employee L.C. provided massage therapy to patients not less than 50 times at the direction of the Respondent. The Respondent was aware that both T.R. and L.C. were not licensed massage therapists.
Several employees were directed by the Respondent to prepare syringes for the injection of medications into patients. The employees had no specific training in the preparation of injections. Utilization of untrained personnel to prepare syringes for an injection is below the applicable standard of care, according to the testimony of Dr. Chaitoff.
The Respondent ordered medications, including controlled substances, from "Southwood Pharmaceuticals" and stored them in a large rolling metal toolbox located within the examination room. The medications included Vicodin, Lortab, Darvocet, Soma, hydrocodone, and Xanax. According to the testimony of Dr. Chaitoff, the Respondent's practice of storing narcotics in a metal toolbox located in an examination room fails to the meet the applicable standard of care in medicine that, at a minimum, requires that such medications be stored in a doubly secured location.
Disposable waste products, including sharps, were not placed into an appropriate container, but were tossed into an
open cardboard box approximately three-feet by three-feet-wide and four feet tall. The cardboard box had no cover and lacked appropriate labeling. At one time, when the Respondent expected a visit from an inspector, he moved the cardboard box of sharps into a shower area in his personal office, where they remained behind the shower curtain.
The Respondent failed to maintain a sterile condition in his practice. Instruments used in surgical procedures were not routinely cleaned after use and were not maintained under sterile conditions in the clinic. One witness testified that she observed the Respondent, about to remove a "boil" from a patient's face, pick up an instrument from a tray, and that she observed a fluid she identified as blood on the instrument. She testified that she had been present on the previous day when the Respondent had used the same instrument in a surgical procedure on another patient. The witness testified that when the Respondent noticed the fluid, he placed the instrument back on the tray and picked up another instrument from the same tray. The witness's testimony is credited.
The Respondent's use of gloves was inconsistent. He did not always wear gloves when examining patients or administering treatment. He sometimes wore the same pair of latex gloves for more than one patient examination. He was
observed wearing stained gloves while drinking coffee and handling patient medical files.
According to the testimony of Dr. Chaitoff, the office practices described herein, including the improper storage and disposal of waste products, the lack of sterile clinical conditions, and the failure to use latex gloves properly, fail to meet the applicable standard of care in medicine and constitute gross malpractice.
Dr. Chaitoff also testified that the extensive violations of standards of care as set forth herein constituted gross and repeated malpractice.
DOAH Case No. 05-0863PL
On or about April 18, 2001, a three-count indictment in Case No. 01-CF-005999 in the Circuit Court, Thirteenth Judicial Circuit, Hillsborough County, Florida, alleged that the Respondent had engaged in sexual activity with a person 12 years of age or older, but less than 16 years of age. The indictment charged the Respondent with three counts of lewd and lascivious battery in violation of Subsection 800.04(4)(a), Florida Statutes (2001).
The charges were resolved on October 29, 2001, when the Respondent entered a guilty plea to one count of felony battery in the third degree in violation of Section 784.041, Florida Statutes (2001). He was adjudicated guilty, and was
sentenced to four years' probation, random drug/alcohol testing, and 100 hours of community service. In addition, the Respondent was ordered to have no unsupervised contact with any person under the age of 18 years.
The Respondent failed to report the conviction to the Petitioner within 30 days as required by Florida law.
Good moral character, honesty, and reliability are qualities essential to the ability to practice of medicine. The crime for which the Respondent was convicted demonstrates a lack of good moral character. The failure to report the crime as required demonstrates a lack of honesty and reliability.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding. §§ 120.569 and 120.57, Fla. Stat. (2001-2004).
The Petitioner has the burden of establishing the allegations of the Administrative Complaints by clear and convincing evidence. Department of Banking and Finance v.
Osborne Stern and Company, 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987). Clear and convincing evidence is that which is credible, precise, explicit, and lacking confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact the firm belief of conviction, without hesitancy, as to the
truth of the allegations. Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983). The Petitioner has met the burden relative to the findings of fact set forth herein.
DOAH Case No. 05-0862PL
The Respondent is guilty of multiple violations of Subsection 458.331(1), Florida Statutes, which identifies relevant grounds for disciplinary action as follows:
§ 458.331(1)(k), Fla. Stat. (2003):
Making deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employing a trick or scheme in the practice of medicine.
§ 458.331(1)(m), Fla. Stat. (2002, 2003, and 2004):
Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
§ 458.331(1)(p), Fla. Stat. (2002 and 2004):
Performing professional services which have not been duly authorized by the patient or client, or his or her legal representative, except as provided in s. 743.064, s.
766.103, or s. 768.13.
§ 458.331(1)(q), Fla. Stat. (2002, 2003, and 2004):
Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.
§ 458.331(1)(t), Fla. Stat. (2002, 2003, and 2004):
Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of
s. 766.102 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in indemnities being paid
in excess of $50,000 each to the claimant in a judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances," shall not be construed so as to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice
medicine in order to be disciplined pursuant to this paragraph. A recommended order by an administrative law judge or a final order of the board finding a violation under this paragraph shall specify whether the licensee was found to have committed "gross malpractice," "repeated malpractice," or "failure to practice medicine with that level of care, skill, and treatment which is recognized as being acceptable under similar conditions and circumstances," or any combination thereof, and any publication by the board must so specify.
§ 458.331(1)(w), Fla. Stat. (2002, 2003, and 2004):
Delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or has reason to know that such person is not qualified by training, experience, or licensure to perform them.
§ 458.331(1)(aa), Fla. Stat. (2004):
Presigning blank prescription forms.
The evidence establishes that the Respondent's billing practices, including upcoding and unbundling, as well as billing for procedures not performed, constitute deceptive, untrue, or fraudulent representations in the practice of medicine in violation of Subsection 458.331(1)(k), Florida Statutes (2003).
The evidence establishes that the Respondent failed to keep medical records justifying the course of treatment provided to patients cited herein in violation of
Subsection 458.331(1)(m), Florida Statutes (2002, 2003, and 2004).
The evidence establishes that in failing to obtain informed consent for injections provided to patients identified herein, the Respondent violated Subsection 458.331(1)(p), Florida Statutes (2002 and 2004).
The evidence establishes that the Respondent inappropriately prescribed controlled substances as set forth herein and thereby violated Subsection 458.331(1)(q), Florida Statutes (2002, 2003, and 2004).
Based on the evidence and the testimony of Dr. Kevin Chaitoff, the Respondent has clearly failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, and thereby violated Subsection 458.331(1)(t), Florida Statutes (2002, 2003, and 2004).
The evidence establishes that the Respondent directed untrained, unqualified, and unlicensed persons to prepare syringes for injections and to provide massage therapy services, and thereby violated Subsection 458.331(1)(w), Florida Statutes (2002, 2003, and 2004). Further in requiring that such persons provide massage therapy, the Respondent violated
Subsection 458.331(1)(nn), Florida Statutes (2003 and 2004)
(providing that violation of Chapter 456, Florida Statutes, constitutes grounds for discipline), by violating Subsection 456.072(1)(j), Florida Statutes, which prohibits "[a]iding, assisting, procuring, employing, or advising any
unlicensed person or entity to practice a profession contrary to this chapter, the chapter regulating the profession, or the rules of the department or the board."
The evidence establishes that the Respondent completed and presigned blank prescription forms which lacked patient names, thereby violating Subsection 458.331(1)(aa), Florida Statutes (2004).
Subsection 458.331(1)(nn), Florida Statutes (2003 and 2004), provides in part that the violation of administrative rules provides further grounds for disciplinary action. The evidence clearly establishes that the Respondent's pain management practices, including, but not limited to, the inappropriate prescribing of controlled substances clearly violated Florida Administrative Code Rule 64B8-9.013, which states as follows:
64B8-9.013 Standards for the Use of Controlled Substances for the Treatment of Pain.
Pain management principles.
The Board of Medicine recognizes that principles of quality medical practice dictate that the people of the State of Florida have access to appropriate and effective pain relief. The appropriate
application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances.
Inadequate pain control may result from physicians' lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Physicians should not fear disciplinary action from the Board or other state regulatory or enforcement agencies for prescribing, dispensing, or administering controlled substances including opioid analgesics, for a legitimate medical purpose and that is supported by appropriate documentation establishing a valid medical need and treatment plan. Accordingly, these standards have been developed to clarify the Board's position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.
The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. The medical management of pain including intractable pain should be based on current
knowledge and research and includes the use of both pharmacologic and non-pharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.
The Board of Medicine is obligated under the laws of the State of Florida to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.
The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law.
Each case of prescribing for pain will be evaluated on an individual basis. The Board will not take disciplinary action against a physician for failing to adhere strictly to the provisions of these standards, if good cause is shown for such deviation. The physician's conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient's individual needs including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved.
The Board will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient's pain for its duration while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors. The following standards are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.
Definitions.
Acute Pain. For the purpose of this rule, "acute pain" is defined as the normal, predicted physiological response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness. It is generally time-limited and is responsive to opioid therapy, among other therapies.
Addiction. For the purpose of this rule, "addiction" is defined as a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as "drug dependence" and "psychological dependence." Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.
Analgesic Tolerance. For the purpose of this rule, "analgesic tolerance" is defined as the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.
Chronic Pain. For the purpose of this rule, "chronic pain" is defined as a pain state which is persistent.
Pain. For the purpose of this rule, "pain" is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.
Physical Dependence. For the purpose of this rule, "physical dependence" on a controlled substance is defined as a physiologic state of neuro-adaptation which is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.
Pseudoaddiction. For the purpose of this rule, "pseudoaddiction" is defined as a pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.
Substance Abuse. For the purpose of this rule, "substance abuse" is defined as the use of any substances for non- therapeutic purposes or use of medication for purposes other than those for which it is prescribed.
Tolerance. For the purpose of this rule, "tolerance" is defined as a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a reduced effect is observed with a constant dose.
Standards. The Board has adopted the following standards for the use of controlled substances for pain control:
Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain,
underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to:
Urine/serum medication levels screening when requested;
Number and frequency of all prescription refills; and
Reasons for which drug therapy may be discontinued (i.e., violation of agreement).
Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician
should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans.
Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.
Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:
The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
Diagnostic, therapeutic, and laboratory results;
Evaluations and consultations;
Treatment objectives;
Discussion of risks and benefits;
Treatments;
Medications (including date, type, dosage, and quantity prescribed);
Instructions and agreements; and
Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review. Records must remain current and be
maintained in an accessible manner and readily available for review.
Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual: An Informational Outline of the Controlled Substances Act of 1970, published by the
U.S. Drug Enforcement Agency, for specific rules governing controlled substances as well as applicable state regulations.
Further, the Respondent has violated
Subsection 458.331(1)(nn), Florida Statutes (2003 and 2004), by violation of Florida Administrative Code Rule 64B8-9.0075(1), which states as follows:
Standards of care and standards of practice require that Florida licensed physicians and physician assistants provide their patients appropriate medical care under sanitary conditions; that medical care is provided pursuant to informed consent, adequately documented and lawfully billed to the patients and/or other payors; and that persons assisting in the delivery of medical care to their patients are licensed, certified, and/or supervised as required by law. Except as specifically provided for in the following practice settings, physicians and physician assistants may neither delegate to others nor reasonably rely upon others to ensure compliance with these patient responsibilities.
DOAH Case No. 05-0863PL
In relevant part, Section 458.331, Florida Statutes (2001), provides as follows:
The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
* * *
(c) Being convicted or found guilty of, or entering a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the practice of medicine or to the ability to practice medicine.
* * *
(nn) Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.
In relevant part, Section 456.072, Florida Statutes (2001), provides as follows:
The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:
* * *
(w) Failing to report to the board, or the department if there is no board, in writing within 30 days after the licensee has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction. Convictions, findings, adjudications, and pleas entered into prior to the enactment of this paragraph must be reported in writing to the board, or department if there is no board, on or before October 1, 1999.
The evidence establishes that the Respondent was convicted of a crime directly related to the ability to practice medicine, in that his conviction demonstrates a lack of good moral character. The evidence further establishes that the Respondent failed to timely report the conviction to the Petitioner, demonstrating a lack of honesty and reliability.
Good moral character, honesty, and reliability are qualities essential to the practice of medicine and to the ability to practice medicine.
The Petitioner's disciplinary guidelines are set forth in Florida Administrative Code Rule 64B8-8.001(2). Revocation of the Petitioner's license is within the range of penalties appropriate under the facts alleged in the Administrative Complaints and established at the hearing.
Florida Administrative Code Rule 64B8-8.001(3) sets forth circumstances permitting the Petitioner to deviate from the guidelines and provides as follows:
Aggravating and Mitigating Circumstances. Based upon consideration of aggravating and mitigating factors present in an individual case, the Board may deviate from the penalties recommended above. The Board shall consider as aggravating or mitigating factors the following:
Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;
Legal status at the time of the offense: no restraints, or legal constraints;
The number of counts or separate offenses established;
The number of times the same offense or offenses have previously been committed by the licensee or applicant;
The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;
Pecuniary benefit or self-gain inuring to the applicant or licensee;
The involvement in any violation of Section 458.331, F.S., of the provision of
controlled substances for trade, barter or sale, by a licensee. In such cases, the Board will deviate from the penalties recommended above and impose suspension or revocation of licensure.
Where a licensee has been charged with violating the standard of care pursuant to Section 458.331(1)(t), F.S., but the licensee, who is also the records owner pursuant to Section 456.057(1), F.S., fails to keep and/or produce the medical records.
Any other relevant mitigating factors.
There are no mitigating circumstances. The disciplinary history of the Respondent is an aggravating circumstance. The Respondent was the subject of a prior proceeding resulting in imposition of a disciplinary penalty. See DOH Case No. 91-12931, Final Order of the Board of Medicine dated December 21, 1999 (DOAH Case No. 96-0024, Recommended Order dated September 17, 1999). Additional aggravating circumstances include exposure of the patients to injury, and the pecuniary gain inuring to the Respondent through billing practices.
Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby
RECOMMENDED that the Department of Health, Board of Medicine enter a final order revoking the license of Lehel Kadosa.
DONE AND ENTERED this 27th day of February, 2006, in Tallahassee, Leon County, Florida.
S
WILLIAM F. QUATTLEBAUM
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675 SUNCOM 278-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 27th day of February, 2006.
COPIES FURNISHED:
Joseph Harrison, Esquire Joseph Harrison, P.A.
2500 North Military Trail, Suite 490 Boca Raton, Florida 33431
Maura M. Bolivar, Esquire Diane K. Kiesling, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
R. S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Larry McPherson, Executive Director Board of Medicine
Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Apr. 21, 2006 | Agency Final Order | |
| Feb. 27, 2006 | Recommended Order | Respondent`s multiple violations of the disciplinary statutes warrant the revocation of his license. |
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs LEHEL KADOSA, M.D., 05-000862PL (2005)
DEPARTMENT OF HEALTH, BOARD OF OSTEOPATHIC MEDICINE vs RICHARD D. VITALIS, D.O., 05-000862PL (2005)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs DONALD A. TOBKIN, M.D., 05-000862PL (2005)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs THOMAS KARL VELLEFF, JR., M.D., 05-000862PL (2005)
