STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, )
BOARD OF MEDICINE, )
)
Petitioner, )
)
vs. ) Case No. 10-3093PL
) ESTABAN ANTONIO GENAO, M.D., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, a formal hearing was held in this case on September 17, 2010, by video teleconference, with the parties appearing in Miami, Florida, before Patricia M. Hart, a duly- designated Administrative Law Judge of the Division of Administrative Hearings, who presided in Tallahassee, Florida.
APPEARANCES
For Petitioner: Diane K. Kiesling, Esquire
Gavin D. Burgess, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
For Respondent: Estaban Antonio Genao, M.D., pro se
13583 Southwest 183rd Terrance Miami, Florida 33177
STATEMENT OF THE ISSUE
Whether the Respondent committed the violations alleged in the Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.
PRELIMINARY STATEMENT
In a six-count Administrative Complaint dated March 26, 2010, the Department of Health ("Department") charged Estaban Antonio Genao, M.D., with the following violations:
Counts One and Four: Prescribing controlled substances for patients V.C. and J.S., respectively, without satisfying the requirements of Florida Administrative Code Rule 64B8- 9.013(3)(a) and (b), in violation of section 458.331(1)(nn), Florida Statutes (2008)1/;
Counts Two and Five: Failing to practice medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances with respect to his treatment of patients V.C. and J.S., respectively, in violation of section 458.331(1)(t); and
Counts Three and Six: Prescribing controlled substances for patients V.C. and J.S., respectively, without satisfying the documentation requirements of rule 64B8- 9.013(3)(a) and (b), and failing to keep legible medical records
that justified the course of treatment provided to patients V.C. and J.S., respectively, in violation of section 458.331(1)(m).
Dr. Genao timely requested an administrative hearing, and the Department transmitted the matter to the Division of Administrative Hearings for the assignment of an administrative law judge. Pursuant to notice, the final hearing was held on September 17, 2010.
At the final hearing, the Department presented the testimony of Paul David Randall, Enrique Torres, and Dr. Genao; Petitioner's Exhibits 1 through 8 were offered and received into evidence. Petitioner's Exhibit 7 consisted of the transcript of the deposition of the Department's expert witness, Marc Gerber, M.D., which was taken on September 13, 2010, and was offered in lieu of Dr. Gerber's live testimony. Dr. Genao testified in his own behalf and presented the testimony of Maida Ramallo and Juan Riccardo-Garcia. Dr. Genao did not offer any exhibits into evidence.
The one-volume transcript of the proceedings was filed with the Division of Administrative Hearings on October 10, 2010, and the parties timely filed proposed findings of fact and conclusions of law,2 which have been considered in the preparation of this Recommended Order.
FINDINGS OF FACT
Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made:
The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat.
At the times material to this proceeding, Dr. Genao was a physician licensed to practice medicine in Florida, having been issued license number ME 58604.
Dr. Genao was board-certified in pediatrics, and, until he closed his office in 2008, he practiced pediatric medicine and complementary medicine, which consists primarily of nutrition counseling and infusion therapy.
From December 2008 to March 2010, Dr. Genao was employed as a physician at the Full Service Pain Management Clinic ("Clinic").
Prior to his employment with the Clinic, Dr. Genao had not practiced medicine in the field of pain management and had
not taken any continuing medical education classes in the field of pain management. His knowledge of pain management medicine prior to his association with the Clinic was limited to the writing of an occasional prescription for Oxycodone or Percoset.
When Dr. Genao learned that the Clinic was looking for a physician, he contacted the Clinic and was interviewed by one of the owners. After he was hired by the Clinic, he observed and worked with the medical director of the Clinic,
Dr. Friedberg, for approximately three weeks. Then, when he began seeing patients at the Clinic on his own, another physician observed him with his first few patients. This was the only formal training he received in pain management medicine.
During the time he was observing the medical director of the Clinic and working with patients at the Clinic, Dr. Genao read about pain management medication in textbooks and on the Internet, and he also attended approximately 35 hours of continuing medical education in the field of pain management medicine.
During the time he was working at the Clinic, Dr. Genao had an endorsement on his medical license allowing him to dispense drugs on the premises.
Dr. Genao began treating patients V.C. and J.S. at the Clinic in December 2008, soon after he began working at the Clinic. They were among his first patients.
Dr. Genao prescribed Roxicodone and Xanax for both
V.C. and J.S. during the course of their treatment. He also prescribed Soma for V.C. on one occasion, and he prescribed Percocet for J.S. on one occasion.
Roxicodone is a rapid release formula of oxycodone.
Oxycodone is an opiate (narcotic) analgesic used for the treatment of acute or chronic pain. Oxycodone is a schedule II controlled substance pursuant to section 893.03(2), Florida Statutes, and has a high potential for abuse. Roxicodone is dispensed in 30-milligram and 15-milligram tablets. This medication begins to relieve pain within 30-to-45 minutes after it is ingested, and it continues to act on pain for up to five hours.
Percocet is the brand name for a combination of oxycodone and acetaminophen, and it differs from Roxicodone only in the addition of acetaminophen.
Xanax, the brand name of alprazolam, is a benzodiazepine sedative hypnotic that is used to treat anxiety.
It is a schedule IV controlled substance pursuant to
section 893.03(4), and it has a low potential for abuse relative to schedule I, II, and III controlled substances.
Soma is the brand name for carisprodol, which is a muscle relaxant commonly prescribed for muscle pain. It is a schedule IV controlled substance pursuant to section 893.03(4), and it has a low potential for abuse relative to schedule I, II, and III substances.
Patient V.C.
V.C.'s first visit to the Clinic was on December 20, 2008. At that time, he was screened by the Clinic's staff.
The screening included completion of forms recording past substance abuse and psychiatric history. V.C. reported that he had no history of drug abuse and no history of a psychiatric diagnosis. V.C. also reported that he had taken, among other drugs, Roxicodone, Valium, Oxydose, Xanax, Lorcet, Percocet, Vicodin, Oxycontin, and Ambien.
On December 20, 2008, V.C. also signed the following documents:
A Pain Management Agreement, in which he agreed to follow the guidelines set forth in the agreement regarding the use of controlled pharmaceuticals, including submitting himself for blood or urine testing at the request of his physician;
A form entitled "Informed Consent to Take Opiate/Narcotic Pain Medication," in which the benefits and risks of taking this type of medication were set out;
A form advising V.C. that, pursuant to section 893.13, Florida Statutes, it was a third degree felony to fail to tell a physician prescribing narcotic pain medication that he had received pain medication from another physician since his last visit to the Clinic and/or to possess narcotic medication by misrepresentation, fraud, subterfuge, forgery, or deception; and
A non-overdose contract, in which V.C. agreed to take the medication as prescribed and agreed to accept full responsibility if an overdose of pain medications occurred.
V.C. also completed an Initial Pain Assessment form on December 20, 2008, in which V.C. reported the following:
He tore his rotator cuff at the gym approximately
20 months prior to his first office visit with Dr. Genao;
His pain was burning and sharp, and he was stiff in the morning;
His pain interfered substantially with his work and made him depressed and irritable;
He had been treated in 2006-2007 by a Dr. Taylor, who had treated him with therapy and cortisone shots, among other modalities, and in 2007-2008 by a Dr. Ward, who did nerve conduction testing; and
d. X-rays and an MRI had been taken of his shoulder.
V.C. was first seen by Dr. Genao on December 23, 2008.
At that time, an Initial Medical Evaluation form was completed, in which the following was noted:
a. V.C. sought a medical evaluation in order obtain medication refills;
b V.C. had previously been seen in a pain clinic in Davie, Florida, in November 2008;
The pain medications currently prescribed for V.C. were Roxicodone and Xanax;
V.C.'s neck and shoulder were the areas affected by the pain;
The level of pain with medication reported by V.C. was three on a scale of ten, while the level of pain without medication was eight on a scale of ten;
The pain was constant, burning, aching, and radiating;
There was limited range of motion in V.C.'s left shoulder, and he could not raise his left arm; and
An MRI scan of the left shoulder was conducted on February 26, 2007.
Dr. Genao obtained a copy of the results of the February 26, 2007, MRI scan, which included the following impression:
Rotator cuff tendinosis involving the supraspinatus tendon. There is bursal-sided fraying. There is undersurface fraying and
some low-grade partial thickness tear in the central distal aspect of the supraspinatus tendon.
Fluid in the overlying subdeltoid bursa reflects moderate bursitis.
AC joint degenerative change, as noted above with evidence of a type 2 anterior acromion.
Labral blunting and fraying along the anterior, anterosuperior, and posterosuperior aspects of the labrum.
Changes that appear to suggest some element of chondral thinning along the bony margin of the glenoid, more evident inferior and posteroinferiorly.
Dr. Genao's diagnosis, as stated on the Initial Medical Evaluation form, was tendonitis.
The blank space on the Initial Medical Evaluation form reserved for a listing of "Non-pharmaceutical pain modifying therapies" was completed with "N/A."
The medication treatment plan that Dr. Genao developed for V.C. consisted of prescriptions for 224 30-milligram tablets of Roxicodone; 56 15-milligram tablets of Roxicodone; and 56 two milligram tablets of Xanax3; this treatment plan was included by Dr. Genao in the Initial Medical Evaluation form.
The long-term goals Dr. Genao identified on the Initial Medical Evaluation form were to "decrease pain" and to "improve enjoyment of daily life activities and social interaction and function."
Dr. Genao completed a History and Physical Examination Form for V.C. on December 23, 2008. Although a small part of the information on the form was illegible, Dr. Genao noted the following:
V.C. suffered from severe pain in his left shoulder due to a weight-lifting injury in November 2006, although he continued to exercise with pain;
V.C. was first seen for his shoulder pain by a Dr. Taylor, who prescribed exercise and treated him with cortisone shots and Percocet;
V.C. continued to experience pain, however, and he was then seen by a Dr. Ward,4 who treated V.C. with 25-to-
30 milligram tablets of Roxicodone;
V.C. worked as a cameraman for a television station, which required him to continually push buttons and pull cables, and it was impossible for him to do his work without pain medication;
V.C. had been taking pain medications for about a year before his appointment with Dr. Genao;
V.C. had not decided whether to have surgery on his shoulder, although he knew it was an option for treating the pain;
V.C.'s previous doctor had prescribed Valium, and then Xanax, to relieve anxiety and stress;
V.C. had no other health problems and no side effects from the medications;
V.C. was divorced and had a young daughter and a 92- year-old mother, for whom he provided care;
V.C. smoked but did not use alcohol;
V.C.'s current medications were 30-milligram tablets of Roxicodone and two-milligram tablets of Xanax;
V.C. may go on work trips and might need prescriptions filled before scheduled.
Under the heading "ROS" on the History and Physical Examination Form, Dr. Genao noted that V.C. reported sleepiness but "none" of the following:
Gen: Confusion, appetite, weakness
Resp: Cough, wheeze, SOB, hemoptysis CVS: CP, palpitations, PND, Syncope,
SOBOE, H/O, HTN, Lipid d/o
GI: N/V/D/C, dark tarry stool, BRBPR, Liver problems
GU: dysuria, urinary retention, frequency urgency, hesitancy, hematuria, kidney problems
Neuro: weakness, numbness, tingling, dizziness, memory, cognition, balance, dexterity, agility
MSKT: brittle bones, muscle tone, strength, joint pain/deformities/limitation/swelling, carpal tunnel
Psych: depression, anxiety, mood, behavioral changes, h/o psychosis
Other than the documents discussed above and copies of the prescriptions Dr. Genao wrote for V.C., the only significant items in Dr. Genao's medical records were "Patient Follow Up Sheets" completed by Dr. Genao for each of V.C.'s appointments subsequent to the initial office visit on December 23, 2008.
After his initial office visit, V.C. had six appointments with Dr. Genao, on January 21, 2009; February 18, 2009; April 3, 2009; May 4, 2009; June 1, 2009; and June 29, 2009. Dr. Genao assessed V.C.'s condition during each office visit, and each follow-up sheet included the date of the appointment, V.C.'s vital signs, and the following notations:
V.C. did not take vitamins, did exercise, and smoked between one-quarter pack to one pack of cigarettes each day;
V.C. experienced pain during normal activities of three on a scale of ten with medications and eight on a scale of ten without medications, except that he reported on May 4, 2009, that he experienced pain during normal activities of two on a scale of ten with medications;
V.C. had no side effects from the medications, had no new complaints or injuries, and had experienced improvement in mood and daily activities,
Lifestyle changes were discussed and notes from previous office visits were reviewed;
V.C. was responding well to the medications;
Dr. Genao and V.C. discussed reducing his medication amounts and making changes in the medication prescribed
for V.C.;
and
All questions and concerns were addressed in detail;
No referral, labs, or diagnostic tests had been
ordered.
The medication prescribed at each appointment, together with Dr. Genao's notes, are included on the "Patient Follow Up Sheet" for each appointment as follows:
January 21, 2009: 224 Roxicodone 30 mg
56 Roxicodone 15 mg
56 Xanax 2 mg
"Pt did fine on his prescriptions. Pain well controlled. No side effects reported."
February 18, 2009: 224 Roxicodone 30 mg
56 Roxicodone 15 mg
56 Xanax 2 mg
"Pt did fine. No side effects reported."
April 3, 2009: 224 Roxicodone 30 mg
84 Roxicodone 15 mg
56 Xanax 2 mg "Tendonitis/bursitis L shoulder [illegible] shoulder
acting up. Pt feels better ± same"
May 4, 2009: 224 Roxicodone 30 mg
84 Roxicodone 15 mg
56 Xanax 2 mg
"Pt doing well. No side effects."
June 1, 2009: 224 Roxicodone 30 mg
84 Roxicodone 15 mg
56 Xanax 2 mg
"Pt doing fine. Active camera man."
June 29, 2009: 196 Roxicodone 30 mg
112 Roxicodone 15 mg
56 Xanax 2 mg
56 Soma 350 mg
"Pt doing well. Active at job. Doing some painting job which increase his pain. Lot of muscle spasms."
Dr. Genao did not conduct a complete physical examination of V.C. during his initial office visit or during subsequent visits. Rather, because V.C. had voiced no other complaints, Dr. Genao performed a limited physical examination on V.C.'s first office visit that focused on his neck and left shoulder, which were the areas of his body that V.C. identified as the sources of his pain. With respect to this limited physical examination, Dr. Genao noted on the Initial Medical Evaluation form that V.C. had a limited range of motion of his left shoulder and was unable to raise his left arm.
According to Dr. Genao, the type of examination he gave V.C. on his initial visit usually takes three-to-five minutes. It was Dr. Genao's practice not to touch the patient or conduct any manual manipulation; rather, Dr. Genao would request that the patient perform movements at his direction, and he would measure the amount of rotation and enter the information on the patient's medical records.
There is nothing in V.C.'s medical records to indicate that Dr. Genao did any type of physical examination during any of V.C.'s subsequent office visits, although his height, weight, and vital signs were taken and recorded on the "Patient Follow- Up Sheet" for each appointment.
Although V.C. reported that he had been seen previously by a Dr. Taylor and a Dr. Ward, neither Dr. Genao nor anyone at the Clinic contacted the offices of these physicians to obtain copies of V.C.'s medical records. Consequently,
Dr. Genao did not have any records of V.C.'s prior medical treatment or of the medications that Dr. Taylor and/or Dr. Ward had prescribed for V.C. Nonetheless, Dr. Genao's treatment plan for V.C. was to continue with the medications that V.C. told
Dr. Genao he had been taking prior to December 23, 2008. In prescribing 224 30-milligram tablets of Roxicodone, 56 15- milligram tablets of Roxicodone, and 56 two-milligram tablets of Xanax for V.C. at his first office visit, Dr. Genao relied exclusively on the information V.C. provided about the type, strength, and quantities of the medications that Dr. Ward had prescribed.
Dr. Genao continued with the medication treatment plan through V.C.'s February 18, 2009, office visit, and he based the strength and quantity of the pain medications he prescribed for
V.C. on his assessment of V.C. at each office visit. The
strength and quantity of Roxicodone and Xanax prescribed for
V.C. remained the same until April 3, 2009, when Dr. Friedberg, the Clinic's medical director, increased to 84 the quantity of 15-milligram tablets of Roxicodone prescribed for V.C.
Dr. Genao followed the lead of Dr. Friedberg at V.C.'s May 4, 2009, office visit and increased the quantity of 15- milligram tablets of Roxicodone prescribed for V.C. to 84, deferring to Dr. Friedberg's knowledge and experience in pain management medicine. At V.C.'s May 4, 2009, office visit,
Dr. Genao also continued to prescribe the 30-milligram tablets of Roxicodone and the two-milligram tablets of Xanax in the quantities he had previously prescribed. Dr. Genao did not change V.C.'s medications at his office visit on June 1, 2009.
At V.C.'s final office visit on June 29, 2009,
Dr. Genao prescribed Soma, a muscle relaxant, for V.C. because
V.C. reported that he had fallen and was having muscle spasms; Dr. Genao reduced the number of 30-milligram tablets Roxicodone from 224 to 196, and he increased the number of 15-milligram tablets of Roxicodone from 84 to 112. Dr. Genao did this because he wanted to increase the number of 15-milligram tablets of Roxicodone available to V.C. for dealing with "break-through pain"5 and because he wanted to decrease the total milligrams of Roxicodone V.C. was taking each day.
According to Dr. Genao, V.C. had decided, after having received other types of treatments, to use pain medication as the modality of treatment for the pain in his shoulder.
Dr. Genao did not discuss different modalities of pain management, such as physical therapy, injection therapy, and surgery, with V.C. because, in Dr. Genao's view, V.C. had the right to chose treatment with pain medication. Because V.C. had made his choice of treatments, Dr. Genao did not refer him to other physicians for any other modality of treatment for his pain or treat him with anti-inflammatory medications.
Dr. Genao did not doubt the truthfulness of the information V.C. provided about the type, quantity, and strength of the medications he was taking at the time of his first office visit with Dr. Genao on December 23, 2008. He did not order
V.C. to submit to urinalysis to determine the amount and type of drugs in V.C.'s system on his first or subsequent visits because Dr. Genao did not consider V.C. to be a patient at high risk of abusing pain medication. Dr. Genao observed that V.C. always kept his appointments, was on time for his appointments, was doing well with his job, and was taking care of his 92-year-old mother and his two-year-old child. In addition, Dr. Genao observed that V.C. behaved in a professional manner during his office visits.
Patient J.S.
J.S.'s first visit to the Clinic was on December 29, 2008. At that time, he was screened by the Clinic's staff.
The screening included completion of forms recording past substance abuse and psychiatric history. J.S. reported that he had no history of drug abuse and no history of a psychiatric diagnosis. J.S. also reported that he had taken, among other drugs, Roxicodone, Percocet, and Lortab.
On December 29, 2008, J.S. also signed the following documents:
A Pain Management Agreement, in which he agreed to follow the guidelines set forth in the agreement regarding the use of controlled pharmaceuticals, including submitting himself for blood or urine testing at the request of his physician;
A form entitled "Informed Consent to Take Opiate/Narcotic Pain Medication," in which the benefits and risks of taking this type of medication were set out;
A form advising J.S. that, pursuant to section 893.13, Florida Statutes, it was a third degree felony to fail to tell a physician prescribing narcotic pain medication that he had received pain medication from another physician since his last visit to the Clinic and/or to possess narcotic medication by misrepresentation, fraud, subterfuge, forgery, or deception; and
A non-overdose contract, in which J.S. agreed to take the medication as prescribed and agreed to accept full responsibility if an overdose of pain medications occurred.
At J.S.'s first office visit with Dr. Genao, on December 29, 2008, an Initial Pain Assessment form was completed, in which J.S. reported the following:
His problem started three years prior to his first office visit with Dr. Genao;
His pain interfered with his work and his daily routine but did not make him irritable, depressed, or angry;
He had been treated in November 2008 by Dr. Beaure, who prescribed 224 30-milligram tablets of Roxicodone, 140
15-milligram tablets of Roxicodone, and 60 two-milligram tablets of Xanax; and
He had an MRI in November 2008.
An Initial Medical Evaluation form was also completed on December 29, 2007, in which the following was noted:
J.S. had been seen in November 2008 by "Dr. Bower" at the AAA pain management clinic;
J.S. decided to go to the Clinic because the AAA pain management clinic had closed;
J.S. sought a medical evaluation in order to obtain medication refills and medication changes;
The pain medications currently prescribed for J.S. were Roxicodone, Xanax, and "Rox 15";
J.S.'s lower back was the area affected by the pain, and it was aggravated by lifting, sitting, standing, walking, and bending;
J.S. reported that the level of pain with medication was "N" on a scale of ten and that the level of pain without medication was ten on a scale of ten;
J.S. described the pain as constant, sharp, stabbing, throbbing, and radiating;
Dr. Genao observed swelling in J.S.'s cervical area, and tenderness, trigger points, and spasms, were observed in his lumbrosacral area; and
An MRI scan of the lumbrosacral area was conducted on November 13, 2008.
J.S. brought a copy of the November 13, 2008, MRI report to his first office visit with Dr. Genao, and this document was included in Dr. Genao's medical records for J.S. The impression stated in the radiologist's report was that J.S. had a disc protrusion between the L3-4 vertebrae that "touches and mildly effaces the dural sac" and a disc protrusion between the L5-S1 vertebrae that "touches the left exiting S1 exiting nerve root".
Dr. Genao's diagnosis, as stated on the Initial Medical Evaluation form, was severe back pain and bulging discs. "No" was filled in the blank space on the Initial Medical Evaluation form reserved for a listing of "Non-pharmaceutical pain modifying therapies."
The medication treatment plan that Dr. Genao developed for J.S. consisted of prescriptions for 224 30-milligram tablets of Roxicodone; 56 15-milligram tablets of Roxicodone; and
56 two-milligram tablets of Xanax6; this treatment plan was set forth on the Initial Medical Evaluation form.
The long-term goals for J.S. that Dr. Genao identified on the Initial Medical Evaluation form were to "decrease pain" and to "improve enjoyment of daily life activities and social interaction and function."
Dr. Genao completed a History and Physical Examination Form for J.S. on December 29, 2008. Although a small part of the information on the form was illegible, Dr. Genao noted the following:
J.S. suffered for three years from severe aches and spasms in his lower back, that radiated to his mid-back and neck and went down both legs, especially his right leg, and to his right testicle;
J.S. described the pain as ten on a scale of ten;
J.S. had been seen by a pain management physician steadily for two years but had to stop this regular pain management treatment because he lacked insurance;
J.S. subsequently obtained pain management medications whenever he could afford them, and, when he was last seen in November 2008, he had received prescriptions for both 30- milligram and 15-milligram tablets of Roxicodone;
J.S. reported that the pain had become unbearable and interfered with his ability to work and that he had anxiety and problems sleeping;
J.S. had no other health problems;
J.S. was married with one child;
J.S. did not smoke or use alcohol or drugs;
J.S.'s current medications were Roxicodone and Xanax;
Under the heading "ROS" on the History and Physical Examination Form, Dr. Genao noted that J.S. reported sleepiness; problems with agility, muscle tone, and strength; and anxiety, but he reported "none" of the following:
Gen: Confusion, appetite, weakness Resp: Cough, wheeze, SOB, hemoptysis
CVS: CP, palpitations, PND, Syncope, SOBOE, H/O, HTN, Lipid d/o
GI: N/V/D/C, dark tarry stool, BRBPR, Liver problems
GU: dysuria, urinary retention, frequency
urgency, hesitancy, hematuria, kidney problems
Neuro: weakness, numbness, tingling, dizziness, memory, cognition, balance, dexterity
MSKT: brittle bones, muscle tone, strength, joint
pain/deformities/limitation/swelling, carpal tunnel
Psych: depression, mood,
behavioral changes, h/o psychosis
Other than the documents discussed above and copies of the prescriptions Dr. Genao wrote for J.S., the only significant items in Dr. Genao's medical records were "Patient Follow Up Sheets" completed for each of J.S.'s appointments with Dr. Genao subsequent to the initial appointment on December 29, 2008.
After his initial office visit, J.S. had four appointments with Dr. Genao, on January 26, 2009; February 23, 2009; March 27, 2009, and April 29, 2009.7 Dr. Genao assessed
at each office visit, and each follow-up sheet included the date of the appointment, J.S.'s vital signs, and the following notations:
J.S. did not take vitamins, did exercise, and smoked between one-quarter pack to one-half pack of cigarettes each day;
J.S. experienced pain during normal activities of three on a scale of ten with medications and ten on a scale of ten
without medications, except that he reported on April 29, 2009, that he experienced pain during normal activities of nine on a scale of ten with medications;
J.S. had no side effects from the medications and had no new complaints or injuries, although he did report at the January 26, 2009, office visit that he had been treated with a "Z-pack" for pneumonia;
J.S. experienced improvement in mood and daily activities;
Lifestyle changes were discussed and notes from previous office visits were reviewed;
J.S. was responding well to the medications;
Dr. Genao and J.S. discussed reducing his medication amounts and making medication changes;
All questions and concerns were addressed in detail;
and
No referral, labs, or diagnostic tests were ordered.
The medication prescribed at each appointment, together with Dr. Genao's notes, are included on the "Patient Follow Up Sheet" for each appointment as follows:
January 26, 2009: 224 Roxicodone 30 mg
112 Roxicodone 15 mg
56 Xanax 2 mg
"Pt doing much better. More active at work. Helping [illegible] and performing well at his job. No side effects reported."
February 23, 2009: 224 Roxicodone 30 mg
56 Xanax 2 mg
112 Percocet 10/650 mg
"Pt did fine. Working almost like a normal person. Pt and wife are happy. Will give Percocet for BTP [breakthrough pain] instead of Roxi 15 mg."
March 27, 2009: 224 Roxicodone 30 mg
112 Roxicodone 15 mg
56 Xanax 2 mg Chantix for 2 weeks
"Pt doing well. Working some over time and now able to play with daughter. Patient looking to quit smoking asking for Chantix"
April 29, 2009: 224 Roxicodone 30 mg
112 Roxicodone 15 mg
56 Xanax 2 mg
"Pt very happy with med. Quitting smoking. Did not take Chantix. 2 deaths in the family."
Dr. Genao did not conduct a full physical examination of J.S. during his initial office visit or during subsequent office visits. Rather, because J.S. had no other complaints, Dr. Genao performed a limited physical examination on J.S.'s first office visit that focused on his back, which was the area of his body that J.S. identified as the source of his pain. With respect to this limited physical examination, Dr. Genao noted on the Initial Medical Evaluation form that J.S. had muscle spasms and tenderness in trigger points.
According to Dr. Genao, the type of examination he gave J.S. on his initial visit usually takes three-to-five
minutes. Although it was Dr. Genao's practice not to touch the patient or conduct any manual manipulation, he touched J.S.'s back at several points to determine if it was tender.
Otherwise, Dr. Genao requested that J.S. perform movements at his direction, and he noted the results on the Initial Medical Evaluation form.
There is nothing in J.S.'s medical records to indicate that Dr. Genao did any type of physical examination during any of J.S.'s subsequent office visits, although his height, weight, and vital signs were taken and recorded on the Patient Follow Up Sheet for each appointment.
J.S. reported that he had been seen previously by Dr. Beaure, but neither Dr. Genao nor anyone at the Clinic
contacted Dr. Beaure's office to obtain copies of J.S.'s medical records. Consequently, Dr. Genao did not have any records of J.S.'s prior medical treatment or of the medications that
Dr. Beaure had prescribed for J.S. Nonetheless, Dr. Genao's treatment plan for J.S. was to continue him on the medications that J.S. told Dr. Genao he had been taking prior to
December 29, 2008. In prescribing 224 30-milligram tablets of Roxicodone, 112 15-milligram tablets of Roxicodone, and 56 two- milligram tablets of Xanax, for J.S. at his first office visit, Dr. Genao relied exclusively on the information J.S. provided
about the type, strength, and quantities of the medications that Dr. Beaure had prescribed.
On February 23, 2009, Dr. Genao substituted
112 10/650-milligram tablets of Percocet for the 112
15-milligram tablets of Roxicodone that he had prescribed on January 26, 2009, at J.S.'s request. J.S. felt that the 15- milligram Roxicodone tablets did not take the edge off of his pain, but the Percocet, which contained ten milligrams of oxycodone and 650 milligrams of acetaminophen, was not as effective as J.S. had expected. Dr. Genao returned to the original prescription of 112 tablets of 15-milligram Roxicodone at J.S.'s March 27, 2009, office visit.
Dr. Genao discussed with J.S. different modalities of pain management, such as physical therapy, injection therapy, and surgery, even though he did not note the substance of this discussion in J.S.'s medical records. J.S., however, chose to manage his pain through medication, and Dr. Genao did not refer
J.S. to any other physicians for other modalities of treatment for his pain or treat him with anti-inflammatory medications.
Dr. Genao did not require J.S. to submit to urinalysis to determine the amount and type of drugs in J.S.'s system on his first or subsequent visits because Dr. Genao did not consider J.S. to be a patient at high risk of abusing pain medications. Dr. Genao did not doubt the truthfulness of the
information J.S. provided regarding the type, strength, and quantity of medications J.S. was taking at the time of his first office visit on December 29, 2008. Dr. Genao observed throughout the time that J.S. was his patient that J.S. always kept his appointments, was on time for his appointments, and behaved in a professional and orderly manner.
General
V.C. and J.S. were among the first patients Dr. Genao treated at the Clinic. He subsequently modified the way in which he approached the treatment of patients seeking help managing pain. He started patients who had not previously taken opioids on small amounts of pain medication and then worked up, or titrated, to the amount that relieved their pain. With V.C. and J.S., however, Dr. Genao prescribed the same type, quantity, and strength of pain medications that they had been taking prior to their first office visits with him because V.C. and J.S. had developed a tolerance for the medications, and Dr. Genao did not want to decrease the amount or change the type of medications and possibly cause them distress or withdrawal symptoms.
It was the Clinic's policy to do urine tests to determine what, if any, drugs were in the patient's system at any given time and to obtain copies of patient's medical records. Dr. Genao conceded that he did not order urine tests or ensure that copies of medical records for V.C. and J.S. were
obtained by Clinic staff, but, again, he explained that V.C. and
J.S. were among his first patients and that he had modified his practices as he became more experienced.
Dr. Genao based the type, strength, and quantity of the pain medications he prescribed on his assessment of his patients at each office visit, and he followed the standard procedure of the Clinic in prescribing both 30-milligram and 15- milligram tablets of Roxicodone. Dr. Genao prescribed 224 30- milligram tablets of Roxicodone for both V.C. and J.S.; this amounted to eight tablets a day, and two tablets were to be taken every four-to-six hours.8 Dr. Genao prescribed
15-milligram tablets of Roxicodone to allow V.C. and J.S. to take a 15-milligram Roxicodone tablet for break-through pain rather than having them take a 30-milligram tablet of Roxicodone tablet before the next dose of the greater-strength Roxicodone was due. In this way, Dr. Genao believed that V.C. and J.S. could control their pain with the least amount of medication
Dr. Genao used pre-printed prescription forms for Roxicodone and Xanax because those forms were routinely used by the doctors practicing at the Clinic. There were a number of pre-printed forms, and the use of these forms did not mean that Dr. Genao failed to tailor the prescriptions to the specific needs of V.C. and J.S., individually.
Summary9
The evidence presented by the Department is not sufficient to establish that Dr. Genao failed to conduct and document appropriate evaluations of V.C. and J.S.10 The Past Substance Abuse and Past Psychiatric History forms, the Initial Pain Assessment forms, the History and Physical Examination Forms, and the Patient's Follow-Up Sheets completed by or for
and J.S. included the following:
Complete medical histories of these patients relating to their need for pain management;
The results of the physical examinations that Dr. Genao performed of the areas related to their complaints of pain to ensure that the symptoms of which they complained correlated with the results of the physical examinations and the information revealed by their MRIs and that there was a medical indication for the use of pain medications;
An assessment of the nature and intensity of V.C.'s and J.S.'s pain, with a rating of their pain on a scale of one to ten both with and without medication, together with a description of the nature of their pain;
A listing of their current and past treatments for pain, as well as the names of the physicians who had treated them for the pain;
A list of underlying or coexistent diseases or conditions that they reported, if any;
The effect of the pain on their physical and psychological functioning;
A history of their substance abuse, if any; and
The diagnoses constituting the medical indications for the prescribing of controlled substances for V.C. and J.S.
The evidence presented by the Department is not sufficient to establish that Dr. Genao failed to develop and document appropriate treatment plans for V.C. and J.S. The medication treatment plans were set forth on the Initial Medical Evaluation forms and indicated the type, strength, and quantity of the medications to be prescribed. The short- and long-term goals for V.C. and J.S. were included on the Initial Medication Evaluation form for each of them and included both a decrease in pain and improved enjoyment of daily activities and social interaction as objectives of the treatment plan and the means by which the success of the treatment was to be measured.
Dr. Genao indicated on the Initial Medication Evaluation forms for V.C. and J.S. that there would be no non-pharmaceutical pain modifying therapies for either patient. After treatment began, Dr. Genao completed a Patient's Follow-Up Form for each of V.C.'s and J.S.'s office visits, in which he indicated that no new referrals, labs, or diagnostic tests had been ordered; he
made notes relating the progress of these patients toward the goals of the treatment plan; and he indicated that he had discussed with V.C. and J.S. reducing the amount of medication or changing medications.
The evidence presented by the Department is also insufficient to establish, with the requisite degree of certainty, that Dr. Genao fell below the level of care, skill, and treatment recognized as appropriate by a reasonably prudent physician, in light of all relevant circumstances, with respect to those aspects of the treatment of V.C. and J.S. identified in the Administrative Complaint. The testimony of the Department's expert witness is found to be generally unpersuasive, with the following but a few examples of the basis for this finding: The Department's expert offered a sometimes meandering commentary on what he considered deficiencies in Dr. Genao's treatment of V.C. and J.S., but he neither limited his commentary to the allegations in the Administrative Complaint, nor articulated the standards of care by which he evaluated Dr. Genao's treatment of
V.C. and J.S. In several instances, the Department's expert was led by the Department's counsel with questions regarding standards of care to which he was required only to respond with a "yes" or a "no." The testimony of the Department's expert was contradictory in important respects, such as when he testified that treatment of V.C.'s shoulder pain with controlled
substances may be needed and then testified that "this kind of medications [sic]" is not what "we use to treat shoulder pain."11 The Department's expert testified in terms of his opinions and his "feelings" about particular matters; used words and phrases such as "seems" and "appears" and "I would state"; and stated conclusions without explanation.
Two of the most problematic aspects of the testimony of the Department's expert were his statements that the quantity and dosage of Roxicodone prescribed by Dr. Genao for V.C. and
J.S. were excessive and that there was no indication for prescribing both 30-milligram and 15-milligram tablets of Roxicodone.12 These statements are specifically rejected as unpersuasive because the Department's expert did not offer any cogent explanation to support these opinions or articulate any standards of care from which he derived the opinions. Indeed, with respect to the testimony that the quantity of Roxicodone prescribed for V.C. and J.S. was excessive, the Department's expert began discussing the manner in which one would titrate the dosage of opioids for a person who was "opioid naïve" when the medical histories provided by V.C. and J.S. established that they had recently been prescribed Roxicodone by other physicians.13 Furthermore, the only explanation the Department's expert provided to support his opinion that Dr. Genao's prescribing both 30-milligram and 15-milligram tablets of
Roxicodone was excessive, "kind of like double dosing almost,"14 was that both 30-milligram and 15-milligram tablets of Roxicodone are immediate release opioids used to treat acute pain. While an accurate statement of fact, this testimony begs the question and did not address Dr. Genao's explanation that he prescribed the 15-milligram tablets of Roxicodone to allow V.C. and J.S. to take a minimal dosage of the drug to combat breakthrough pain, a subject which the Department's expert also failed to address.15
The opinion of the Department's expert that Dr. Genao should have ordered urine drug screens for V.C. and J.S. in order to meet what he would "consider" the standard of care is unpersuasive, first, because the Department's expert never articulated a standard of care related to the routine administration of urine drug screens and, second, because he based his opinion that these patients should have been administered urine drug-screening tests on his assumptions that
V.C. and J.S. were at high risk of drug abuse and/or diversion.16 These assumptions, however, were based on nothing more than the amount and type of medications prescribed for V.C. and J.S.
With respect to V.C., the Department's expert testified that "[t]he nature of these prescriptions alone place this patient into a high risk category because of the combination that are [sic] very abusable, have a high street
value, and are [sic] highly diverted."17 With respect to J.S., the Department's expert testified that "[a] twenty[-]eight year[-]old male on this much medication, that would be a high risk patient"18 and that
[t]his is a patient requiring or requesting a very, very high combination of multiple controlled substances. So that alone would be cause for concern. I mean, signs are patients losing their scripts, selling them, knowing that they have other recreational or illicit substances in the urine. So I would say he [J.S.] has the symptoms of potential substance abuse or diversion.[19]
The Department's expert did not base his assumptions that V.C. and J.S. were high-risk patients on any evidence in the record that either of them claimed to have lost prescriptions or gave any indication whatsoever that they were diverting and/or abusing the medications Dr. Genao prescribed for them. In addition, by basing his assumption that V.C. and J.S. were at high risk of medication abuse exclusively on the type and amount of medications Dr. Genao was prescribing for them, the Department's expert failed to consider the individual characteristics, circumstances, or conditions of V.C. and J.S. The notes that Dr. Genao included on the Patient Follow Up Sheets for V.C. and J.S. indicated that V.C. and J.S. were both doing well on their medications; that they had no side effects; that their activities of daily were improving; that they were able to perform their jobs better than they could without
medication; and, with respect to J.S., that he was able to play with his daughter and that he and his wife were very happy.
The testimony of the Department's expert witness is not sufficient to establish that Dr. Genao violated any standard of care by failing to refer V.C. or J.S. for modalities of treatment other than medication to control their pain. First, the Department's expert did not articulate a standard of care with respect to the circumstances in which it would be appropriate for a physician to refer a patient for treatment modalities such as physical therapy, surgery, neuropathic medications, or pain blocks or the circumstances in which it would be appropriate to treat a patient with muscle relaxers or anti-inflammatory medications. In fact, the testimony of the Department's expert was inconsistent with respect to his opinion regarding the appropriate treatment for V.C.'s shoulder pain: He testified that treatment with pain medications would be appropriate for V.C.; he testified that he "could support"
Dr. Genao's treatment of V.C. for at least the short term; he testified that pain medications were "not something that we use to treat shoulder pain"; and, finally, he testified, without any supporting explanation, that Dr. Genao should have referred V.C. to an orthopedic surgeon for surgery.20
With respect to J.S., the Department's expert witness merely acknowledged, in response to a question posed by the
Department's counsel, that he did not see any recommendations in the medical records for J.S. for treatment modalities other than pain medication; he continued his testimony with a statement regarding his practice of putting patients on opioids only as "a last resort," after having obtained the opinions of surgeons and other clinicians,"21 but this opinion was not given in the context of the standard of care which would be followed by a reasonably prudent similar physician under similar conditions and circumstances.
Finally, with respect to a physician's utilizing treatment modalities other than pain medications, the Department's counsel posed the following question: "Is it within the standard of care for a physician to merely recommend that the patient undergo these modalities or should they [a physician] require that they [a patient] undergo them?"22 The Department's expert witness responded:
Well, I mean, I think that depends on a physician's judgment. When we talk about prescribing medications like this I think a prudent physician should mandate that a patient at least see some other colleagues to help co-manage a difficult case. It's not mandatory but I think it would be highly recommended.[23]
Not only does this testimony fail to address a standard of care relating to utilization of other treatment modalities, the opinion of the Department's expert regarding a practice that he
considers "highly recommended" is limited to "a difficult case." The Department's expert witness did not, however, testify that the cases of V.C. and J.S. were difficult cases, so that this opinion is irrelevant to the issues in this case. Finally, and importantly, the Department's expert concedes that a physician should use his or her own judgment with respect to referrals for treatment modalities for pain other than pain medications.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding and of the parties thereto pursuant to sections 120.569 and 120.57(1), Florida Statutes (2010).
Section 458.331(1), Florida Statutes, authorized the Board to impose penalties ranging from the issuance of a letter of concern to revocation of a physician's license to practice medicine in Florida and/or the imposition of an administrative fine if a physician committed one or more acts specified in that subsection. In Counts One and Four of its Administrative Complaint, the Department has charged Dr. Genao with having violated Florida Administrative Code Rule 64B8-9.013(3) and, thereby, having violated section 458.331(1)(nn); in Counts Two and Five, of its Administrative Complaint, the Department has charged Dr. Genao with having violated section 458.331(1)(t); and, in Counts Three and Six of its Administrative Complaint,
the Department has charged Dr. Genao with having violated section 458.331(1)(m).24
The Department seeks to impose penalties against Dr. Genao that include suspension or revocation of his license
and/or the imposition of an administrative fine. Therefore, the Department has the burden of proving the violations alleged in the Administrative Complaint by clear and convincing evidence.
Dep't of Banking & Fin., Div. of Sec. & Investor Prot. v. Osborne Stern & Co., 670 So. 2d 932 (Fla. 1996); Ferris v.
Turlington, 510 So. 2d 292 (Fla. 1987); Pou v. Dep't of Ins. & Treasurer, 707 So. 2d 941 (Fla. 3d DCA 1998); and § 120.57(1)(j), Fla. Stat. (2010)("Findings of fact shall be based on a preponderance of the evidence, except in penal or licensure disciplinary proceedings or except as otherwise provided by statute.").
"Clear and convincing" evidence was described by the court in Evans Packing Co. v. Department of Agriculture Consumer Services, 550 So. 2d 112, 116, n. 5 (Fla. 1st DCA 1989), as follows:
. . . [C]lear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the evidence must be precise and explicit and the witnesses must be lacking in 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 or conviction, without hesitancy, as to the truth of the allegations sought to be established. Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).
Judge Sharp, in her dissenting opinion in Walker v.
Florida Department of Business & Professional Regulation, 705 So. 2d 652, 655 (Fla. 5th DCA 1998)(Sharp, J., dissenting), described clear and convincing evidence as follows:
Clear and convincing evidence requires more proof than preponderance of evidence, but less than beyond a reasonable doubt. In re Inquiry Concerning a Judge re Graziano, 696 So. 2d 744 (Fla. 1997). It is an intermediate level of proof that entails both qualitative and quantative [sic] elements. In re Adoption of Baby E.A.W., 658 So. 2d 961, 967 (Fla. 1995), cert.
denied, 516 U.S. 1051, 116 S. Ct. 719, 133
L. Ed. 2d 672 (1996). The sum total of evidence must be sufficient to convince the trier of fact without any hesitancy. Id. It must produce in the mind of the trier of fact a firm belief or conviction as to the truth of the allegations sought to be established. Inquiry Concerning Davie, 645 So. 2d 398, 404 (Fla. 1994).
Counts One and Four
Section 458.331(1)(nn), Florida Statutes, provided that the Board may take disciplinary action against a physician who has violated "any provision of this chapter or chapter 456, or any rules adopted pursuant thereto."
In Counts One and Four of the Administrative Complaint, the Department has charged that, with respect to V.C.
and J.S., Dr. Genao violated section 458.331(1)(nn) by violating the provisions of Florida Administrative Code Rule 64B8- 9.013(3)(a) and (b).
Rule 64B8-9.013(3), which is entitled "Standards for the Use of Controlled Substances for the Treatment of Pain," provides in pertinent part:
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.
In Count One of the Administrative Complaint, the Department alleged that, with respect to his treatment of V.C., Dr. Genao violated rule 64B8-9.013(3)(a) and (b) in the following respects:
[B]y prescribing one or more of the following controlled substances, Oxycodone, Percocet,[25] Roxicodone and/or Soma to patient VC in the quantities and combinations described above, without conducting or documenting complete medical histories or physical examinations of VC and without documenting one or more of the following: the nature and intensity of the patients' pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function or history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and without documenting written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.
In Count Four of the Administrative Complaint, the Department alleged that, with respect to his treatment of J.S., Dr. Genao violated rule 64B8-9.013(3)(a) and (b) in the following respects:
[B]y prescribing one or more of the following controlled substances, Oxycodone, Roxicodone and/or Soma[26] to patient JS in the quantities and combinations described above, without conducting or documenting complete medical histories or physical examinations of JS and without documenting one or more of the following: the nature and intensity of the patients' pain, current and
past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function or history of substance abuse, the presence of one or more recognized medical indications for the use of a controlled substance and without documenting written treatment plans that state objectives that will be used to determine treatment success or indicate if any further diagnostic evaluations or other treatments are planned.
Based on the findings of fact herein and for the reasons discussed in paragraphs 64 and 65 herein, the Department has failed to meet its burden of proving by clear and convincing evidence that Dr. Genao committed the acts alleged in Counts One and Four. The Department has, therefore, failed to meet its burden of proving by clear and convincing evidence that
Dr. Genao violated rule 64B8-9.013(3)(a) and (b), and, accordingly, it has failed to prove that Dr. Genao committed a violation of section 458.331(1)(nn) with respect to the documentation and treatment plans maintained for V.C. and J.S. Counts Two and Five
Section 458.331(1)(t) provided that the Board may take disciplinary action against a physician who is guilty of the following:
Notwithstanding s. 456.072(2) but as specified in s. 456.50(2):
Committing medical malpractice as defined in s. 456.50. The board shall give
great weight to the provisions of s. 766.102 when enforcing this paragraph.
Medical malpractice shall not be construed 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 medical malpractice," "repeated medical malpractice," or "medical malpractice," or any combination thereof, and any publication by the board must so specify.
Section 456.50(1)(g), Florida Statutes, defined medical malpractice in pertinent part as follows: "Medical malpractice" means the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure." Section 766.102(1), Florida Statutes, provided in pertinent part: "The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers."
In Count Two of the Administrative Complaint, the Department alleged that, with respect to his treatment of V.C.,
Dr. Genao committed medical malpractice between December 23, 2008, and June 29, 2009, in the following respects:
By failing to show in the medical records the justification for prescribing Roxicodone in such high doses;
By prescribing excessive and inappropiate amounts of Roxicodone;
By failing to order urine drug screening in view of the high dosages of opioids being prescribed;
By failing to show in the medical records the justification for prescribing opioids in the dosages prescribed;
By failing to show in the medical records the justification for prescribing a combination of two or more immediate short- acting opioids;
By prescribing concurrent prescriptions of immediate release opioids in combination and at the dosages prescribed;
By violating the standards for use of controlled substances for pain control provided by the Board of Medicine in
Rule 64B8-9.013(3), Florida Administrative Code;
By failing to pursue or document an appropriate treatment plan for Patient VC;
By failing to utilize other services such as physical therapy, pain blocks, neuropathic medications, nonscheduled medications such as muscle relaxers or anti- inflammatory medications;
By failing to record in the medical records any evidence of physical examinations or the documentation of function.
In Count Five of the Administrative Complaint, the Department alleged that, with respect to his treatment of J.S., Dr. Genao committed medical malpractice between December 29, 2008, and April 29, 2009, in the following respects:
By failing to show in the medical records the justification for prescribing Roxicodone in such high doses;
By prescribing excessive and inappropiate amounts of Roxicodone;
By failing to order urine drug screening in view of the high dosages of opioids being prescribed;
By failing to show in the medical records the justification for prescribing opioids in the dosages prescribed;
By failing to show in the medical records the justification for prescribing a combination of two or more immediate short- acting opioids;
By prescribing concurrent prescriptions of immediate release opioids in combination and at the dosages prescribed;
By violating the standards for use of controlled substances for pain control provided by the Board of Medicine in
Rule 64B8-9.013(3), Florida Administrative Code;
By failing to pursue or document an appropriate treatment plan for Patient JS;
By failing to utilize other services such as physical therapy, pain blocks, neuropathic medications, nonscheduled medications such as muscle relaxers or anti- inflammatory medications;
By failing to record in the medical records any evidence of physical examinations or the documentation of function.
With respect to the allegations regarding deficiencies in Dr. Genao's medical records, as set forth by the Department in paragraphs a), d), e), and j) of Counts Two and Five, such alleged violations are not properly categorized as medical malpractice. In Barr v. Department of Health, Board of Dentistry, 954 So. 2d 668 (Fla. 1st DCA 2007), Dr. Barr, a dentist, was charged with failing to meet the standard of care for dentists for his treatment of a patient and with failing to maintain adequate records associated with the treatment. An administrative law judge found that, although Dr. Barr had met or exceeded the standard of care as to his actual treatment of the patient, his medical records were so inadequate that they were below the standard of care.
The Board of Dentistry issued a final order accepting the findings of the administrative law judge. On appeal, the district court recognized that the Board of Dentistry's interpretation of a statute it was charged with administering was entitled to great weight, but it disagreed with the Board of Dentistry's interpretation of its standard of care statute, as follows:
The Board argues that particularly egregious recordkeeping violations could rise to the level of a "standard of care" violation.
Because this interpretation renders subsection (m) [the equivalent of section 458.331(1)(m)] useless, it is clearly erroneous. We believe there is a significant difference between improperly diagnosing a patient, which constitutes a subsection (x) violation [the equivalent of section 458.331(1)(t)], and properly diagnosing a patient, yet failing to properly document the actions taken on the patient's chart, which constitutes a subsection (m) violation.
Barr, 954 So. 2d at 669. Similarly, the allegations in Counts Two and Five regarding deficiencies in Dr. Genao's medical records cannot rise to the level of a violation of
section 458.331(1)(t)(1).27
Based on the findings of fact herein and for the reasons discussed in paragraphs 66 through 72 herein, the Department has failed to meet its burden of proving by clear and convincing evidence that Dr. Genao committed the acts alleged in paragraphs b), c), f), g), h), and i) of Counts Two and Five. The Department has, therefore, failed to meet its burden of proving by clear and convincing evidence that Dr. Genao committed medical malpractice in accordance with the definitions thereof, and, accordingly, it has failed to prove that Dr. Genao violated section 458.331(1)(t)(1) with respect to the care and treatment of V.C. and J.S.
Counts Three and Six
Section 458.331(1)(m) provided that the Board may take disciplinary action against a physician who is guilty of the following:
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.
In Counts Three and Six of the Administrative Complaint, the Department included allegations related to
rule 64B8-9.013(3) that are identical in every material respect to the allegations in Counts One and Four, together with the allegation that, with respect to the medical records that
Dr. Genao maintained for V.C. and J.S., Dr. Genao "failed to maintain medical records that contained a physical examination, medical history, treatment plan, or justification for course of treatment."
For the reasons set forth in paragraph 83 herein, the Department failed to meet its burden of proving by clear and
convincing evidence that Dr. Genao failed to keep medical records for V.C. and J.S. that included the information required in rule 64B8-9.013(3)(a) and (b). In addition, based on the findings of fact herein and for the reasons discussed in paragraphs 64 and 65 herein, the Department has also failed to prove by clear and convincing evidence that Dr. Genao failed to include the information enumerated in Counts Three and Six in his medical records for V.C. and J.S. The Department has, therefore, failed to prove by clear and convincing evidence that Dr. Genao violated section 458.331(1)(m).
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the all counts of the Administrative Complaint against Esteban A. Genao, M.D.
DONE AND ENTERED this 28th day of January, 2011, in Tallahassee, Leon County, Florida.
S
Patricia M. Hart 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 28th day of January, 2011.
ENDNOTES
1/ All references herein to the Florida Statutes are to the 2008 edition unless otherwise specified.
2/ It is noted that Dr. Genao attached to his proposed findings of fact and conclusions of law two letters that were not offered into evidence at the final hearing. On October 27, 2010, the Petitioner filed Petitioner's Motion to Strike Portion of Respondent's "Open Statement," in which it pointed out that
Dr. Genao referred to these letters in his statement. Because the letters are not part of the record in this case, the Petitioner's motion to strike the letters and all references thereto in Dr. Genao's "Open Statement" is granted.
3/ Although the Department included in its Administrative Complaint factual allegations relating to Dr. Genao's having prescribed Xanax for V.C., it is significant that none of the charges in Counts One through Three of the Administrative Complaint included any reference to Dr. Genao's having prescribed this medication.
4/ In the Initial Pain Assessment form apparently completed by V.C., he identified his doctor in 2007-2008 as "Dr. Ward." In his notes, Dr. Genao refers to this doctor as "Dr. Wong." Upon consideration and in the absence of any other item in
Dr. Genao's medical records identifying V.C.'s previous doctor, this doctor will be referred to as Dr. Ward.
5/ "Break-through pain" is pain that occurs between scheduled doses of an immediate-release pain reliever like Roxicodone.
6/ Although the Department included in its Administrative Complaint factual allegations relating to Dr. Genao's having prescribed Xanax for J.S., it is significant that none of the charges in Counts Four through Six of the Administrative Complaint included any reference to Dr. Genao's having prescribed this medication.
7/ Subsequent to his office visit on April 29, 2009, J.S. chose to move to a clinic closer to his home, and he was terminated by the Clinic.
8/ Dr. Genao's patients were seen every 28 days, and he wrote the prescriptions for 28-day periods.
9/ To the extent that the findings of fact in paragraphs 66 through 72 herein are inconsistent with the testimony of the Department's expert witness, it is noted that a trier of fact such as the undersigned may reject even the uncontroverted testimony of expert witnesses. See Thompson v. Dep't of Children & Families, 835 So. 2d 357, 360 (Fla. 5th DCA 2003)("The trier of fact, however, may accept or reject all or any part of an expert's testimony and is in no way bound by uncontroverted expert opinion testimony.").
10/ It should be noted that the violations alleged with respect
to V.C. in Counts One, Two, and Three of the Administrative Complaint are identical to the violations alleged with respect to J.S. in Counts Four, Five, and Six. Consequently, the evidence relating to the violations charged against both V.C. and J.S. are analyzed together.
11/ Petitioner's Exhibit 7 at pages 16 and 20.
12/ It should also be noted that, although there were questions from the Department's counsel and opinions offered by the Department's expert regarding Dr. Genao's prescribing Xanax for
V.C. and J.S, none of the violations alleged in Counts One through Six mentioned Xanax or the prescribing by Dr. Genao of a benzodiazepine hypnotic sedative.
13/ Petitioner's Exhibit 7 at pages 19 and 20. It should be added that, although the Department's expert testified at length and in a number of different contexts that a physician should never accept the word of a pain management patient regarding the type, quantity, and/or dosage of opioid medications that had been prescribed by a prior treating physician, Dr. Genao has not been charged with having committed medical malpractice for failing to verify this information with either V.C.'s or J.S.'s pharmacy or previous physician.
14/ Petitioner's Exhibit 7 at page 18.
15/ It is also noted that the Department's expert testified that Dr. Genao increased the quantity of 15-milligram tablets of
Roxicodone that he prescribed for V.C. without explanation or justification in the medical records. Petitioner's Exhibit 7 at page 26. The Department's expert did not mention, however, that the total dosage of Roxicodone prescribed for V.C. remained the same; when Dr. Genao increased the number of 15-milligram tablets of Roxicodone from 84 to 112, he also decreased the number of 30-milligram tablets of Roxicodone from 224 to 196.
16/ The Department's expert also testified that Dr. Genao should have ordered urine drug screening for V.C. and J.S. at their initial visits with Dr. Genao because, in his opinion, Dr. Genao should not have taken accepted their representations that they had been prescribed Roxicodone by their previous physicians.
See Petitioner's Exhibit 7 at page 17 ("[W]hen it comes to prescribing opiates you just cannot rely on the patient's own history. It needs to be verified . . . by . . . urine testing.") This contention is not relevant to the Department's charges that Dr. Genao committed medical malpractice by "failing to order urine drug screening in view of the high dosages of opioids being prescribed." See Administrative Complaint at paragraphs 28.c. and 48.c.
17/ Petitioner's Exhibit 7 at page 24. 18/ Petitioner's Exhibit 7 at page 39. 19/ Petitioner's Exhibit 7 at page 40.
20/ Petitioner's Exhibit 7 at pages 15-16 and 20.
21/ Petitioner's Exhibit 7 at page 39. 22/ Petitioner's Exhibit 7 at page 26. 23/ Id.
24/ Because the charges in Counts One, Two, and Three with respect to V.C. are identical in every respect to the charges in Counts Four, Five, and Six with respect to J.S., and the charges in the respective counts will be analyzed together.
25/ The Department presented no evidence to establish that Dr. Genao ever prescribed Soma for V.C.
26/ The Department presented no evidence to establish that Dr. Genao ever prescribed Soma for J.S.
27/ There is another reason why the Department has failed to carry its burden of proving by clear and convincing evidence that Dr. Genao's medical records for V.C. and J.S. violate the applicable standard of care. As pointed out by the Department in paragraph 92 of its Proposed Recommended Order, the Board in Department of Health, Board of Medicine v. Armand, Case No. 08- 4285PL (Fla. DOAH June 17, 2009; Fla. DOH, Bd. of Med.,
August 27, 2009), adopted the holding of the Administrative Law Judge at page 28, paragraph 67 of the Recommended Order that, once the Board has established a standard of care by rule, any violation of the rule's provisions would constitute a violation of the standard of care. Consistent with this holding,
rule 64B8-9.013(3) establishes the standard of care for the use of controlled substances by physicians for the treatment of pain.
Rule 64B8-9.013(3)(f) provides the standard of care for medical records applicable to physicians prescribing controlled substances:
(f) 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.
None of the Department's allegations in Counts Two and Five regarding the sufficiency of Dr. Genao's medical record for V.C. and J.S. relates to the requirements for medical records contained in rule 64B8-9.013(3)(f), and these allegations cannot, therefore, form the basis for a violation of the standard of care for use of controlled substances.
COPIES FURNISHED:
Diane K. Kiesling, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
Estaban Antonio Genao, M.D. 13583 Southwest 183rd Terrace Miami, Florida 33177
R. S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
E. Renee Alsobrook, Acting General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399 1701
Larry McPherson, Jr., Executive Director Board of Medicine
Department of Health
4052 Bald Cypress Way, Bin C03 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. 08, 2011 | Agency Final Order | |
| Jan. 28, 2011 | Recommended Order | Petitioner failed to prove Respondent committed medical malpractice in prescribing controlled substances, failed to keep required documentation, or kept inadequate medical records. Administrative Complaint should be dismissed. |
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