Registrant Actions - 2012
[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Pages 57116-57126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22848]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-31]
Cleveland J. Enmon, Jr., M.D.; Decision and Order
On April 26, 2012, Administrative Law Judge Gail A. Randall (ALJ)
issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the entire record in this matter, I have decided to
adopt the ALJ's recommended rulings, findings of fact,\1\ conclusions
of law, and recommended order. Accordingly, I will order that
Respondent's registration be revoked and that his pending application
to renew and modify his registration be denied.
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\1\ The ALJ made several factual findings based on the
statements made to a Special Agent by two employees of the Brunswick
Wellness Center (BWC) during the execution of a search warrant, as
well as statements made during interviews the Special Agent
conducted of several patients of Respondent's subsequent clinic. See
ALJ Slip Op. at 7 (statements of BWC employees that clinic lacked
basic medical equipment and attracted patients from out-of state who
did not appear to be in pain), id. at 9-10 (statement of Ocean Care
patient that he obtained controlled substances from Respondent in
order to sell them on the street and that Respondent did not perform
a physical examination and increased prescription upon request).
While the ALJ found the Special Agent's testimony credible, as do I,
the ALJ did not apply the factors for assessing the reliability of
the underlying hearsay statements as set forth in the case law of
either the Eleventh or DC Circuits. See Basco v. Machin, 514 F.3d
1177, 1182 (11th Cir. 2008); J.A.M. Builders v. Herman, 233 F.3d
1350, 1354 (11th Cir. 2000); Hoska v. United States Dep't of the
Army, 677 F.2d 131, 138 (DC Cir. 1982). However, I conclude that
this does not constitute prejudicial error because the ALJ's legal
conclusions are amply supported by substantial evidence, including
the uncontroverted testimony of the Government's Expert, and the ALJ
did not cite these statements as support for her conclusion that
Respondent repeatedly prescribed controlled substances without a
legitimate medical purpose and outside the course of professional
practice in violation of both federal and state law. See ALJ Slip.
Op. at 38-44 (citing 21 CFR 1306.04(a) and Ga. Code Ann. 16-13-
41(f)).
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration No. BE9655284, issued to Cleveland J. Enmon, Jr., M.D.,
be, and it hereby is, revoked. I further order that the pending
application of Cleveland J. Enmon, Jr., M.D., to renew and modify his
registration, be, and it hereby is, denied. This Order is effective
immediately.\2\
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\2\ For the same reasons that I concluded that Respondent's
conduct posed an imminent danger to public health and safety and
warranted the Immediate Suspension of his registration, I conclude
that the public interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
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Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
Brian Bayly, Esq., for the Government
Cleveland J. Enmon, Jr., M.D., for the Respondent
RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION
OF THE ADMINISTRATIVE LAW JUDGE
Gail A. Randall, Administrative Law Judge.
I. PROCEDURAL BACKGROUND
The Administrator of the Drug Enforcement Administration
("DEA" or "Government"), issued an Order to Show Cause and
Immediate Suspension of Registration ("Order") dated January 10,
2012, immediately suspending the DEA Certificate of Registration,
No. BE9655284, of Cleveland J. Enmon, Jr., M.D. ("Respondent"),
pursuant to 21 U.S.C. 824(d), and proposing to revoke his DEA
Certificate of Registration as a practitioner, pursuant to 21 U.S.C.
824(a)(4), and to deny any pending applications for renewal of such
registration, pursuant to 21 U.S.C. 823(f), because the continued
registration of the Respondent would be inconsistent with the public
interest, as that term is used in 21 U.S.C. 823(f). [Administrative
Law Judge Exhibit ("ALJ Exh.") 1 at 1].
The Order stated that Respondent is registered with the DEA as a
practitioner with authority to handle controlled substances in
Schedules II-V, and that his registration expired by its terms on
August 31, 2011. [Id.]. The Order further stated that although
Respondent submitted a timely renewal application, which would have
allowed him to lawfully handle controlled substances under 5 U.S.C.
558(c) (2006), his current practice location is not at his DEA
registered address because he abandoned that location. Therefore, he
is not permitted to issue controlled substances from his current
practice location. [Id.].
The Order alleged that Respondent issued controlled substances
prescriptions from locations in Brunswick, Georgia and Jesup,
Georgia, without obtaining permission from the Government to change
his DEA registered address to either of these locations. [Id. at 2].
Next, the Order alleged that Respondent had prescribed oxycodone
and hydrocodone to at least nineteen patients with no or
insufficient medical history, with no relevant physical
examinations, without diagnosing any medical conditions warranting
such medications and without monitoring the patients to determine if
the patients were diverting the controlled substances. [Id.]. The
Order also asserted that Respondent had prescribed alprazolam to
eighteen of these patients with no diagnosis or other justification
except for checking a boilerplate form marked "anxiety" in the
patient file. [Id.]
Lastly, the Order alleged that Respondent prescribed two hundred
and thirty dosage units of oxycodone to patient, M.B.S. based on a
diagnosis with no documentation. [Id.]. The Order alleged that this
patient was admitted to a local hospital emergency room and that the
hospital subsequently determined that the patient was opiate
dependent and needed detoxification treatment. [Id.]. Further, the
Order alleged that on October 11, 2011, the Respondent prescribed
the same patient sixty dosage units of alprazolam without
documenting any findings of anxiety symptoms in the patient's file.
[Id.].
The Administrator then gave the Respondent the opportunity to
show cause as to why his registration should not be revoked on the
basis of those allegations. [Id. at 3].
On February 3, 2012, Respondent filed a request for a hearing in
the above-captioned matter. [ALJ Exh. 3].
On March 1, 2012, a Protective Order was issued to protect
patient names and medical files used in this proceeding. [ALJ Exh.
6].
The hearing was conducted on March 6-7, 2012, in Beaufort, South
Carolina. [ALJ Exh. 5]. At the hearing, counsel for the DEA called
three witnesses to testify and introduced documentary evidence.
[Transcript ("Tr.") Volume I-II]. The Respondent called one
witness to testify and testified on behalf of himself. [Id.].
After the hearing, the Government submitted Proposed Findings of
Fact, Conclusions of Law and Argument ("Govt. Brief"). The
Respondent did not submit a post-hearing brief.
II. ISSUE
The issue in this proceeding is whether or not the record as a
whole establishes by a preponderance of the evidence that the Drug
Enforcement Administration should revoke the DEA Certificate of
Registration Number BE9655284 of Cleveland J. Enmon, Jr., M.D., as a
practitioner, pursuant to 21 U.S.C. 824(a) (2006), and deny any
pending applications for renewal or modification of such
registration, pursuant to 21 U.S.C. 823(f), because his continued
registration would be inconsistent with the public interest, as that
term is defined in 21 U.S.C. 823(f). [Tr. 5; ALJ Exh. 4].
III. FINDINGS OF FACT
A. Dr. Enmon's Registration History
The Agency first issued a certificate of registration as a
practitioner to Dr. Enmon on March 9, 2006. [Govt. Exh. 3 at 4]. On
September 4, 2008, Dr. Enmon requested to
[[Page 57117]]
change his DEA registered address from King/Drew Medical Center in
Los Angeles, California to Cleveland Health Care in Atlanta,
Georgia. [Id.; Tr. 179]. The DEA approved Respondent's request for
an address change that same day. [Govt. Exh. 3 at 3].
Dr. Enmon ceased practicing at Cleveland Health Care in
approximately 2009. [Tr. 177]. On August 31, 2011, Dr. Enmon
requested to change his DEA registered address from Cleveland Health
Care in Atlanta, Georgia, to Ocean Care Clinic in Jesup, Georgia.
[Govt. Exh. 3 at 1; Tr. 175-176]. The DEA did not approve Dr.
Enmon's address change request. [Tr. 176]. Therefore, Dr. Enmon's
DEA registered address remains at Cleveland Health Care in Atlanta,
Georgia. [Tr. 175; Govt. Exh. 3].
DEA Diversion Investigator Charles Sikes testified at the
hearing. I find his testimony credible and consistent with the
documentary evidence in the record. He testified that the DEA does
not automatically grant address change requests. [Tr. 176]. Instead,
the DEA treats an address change request as a new application for
registration. [Id.]. He further testified that registrants must
request a change of address if they leave their current registered
location. [Tr. 205]. He also testified that Dr. Enmon was not
entitled to the practitioner exemption under 21 C.F.R. 1301.12(b)(3)
(2011) because he had ceased practicing at his original registered
location in Atlanta, Georgia. [Tr. 204-205].
B. Dr. Enmon
Dr. Enmon received an undergraduate degree from Morehouse
College and then attended medical school at the Morehouse School of
Medicine. [Tr. 330]. After graduating from medical school,
Respondent began a residency program in emergency medicine, at the
Martin Luther King Jr./Drew Medical Center in Los Angeles,
California. [Id.]. Following his residency training, Respondent
practiced emergency medicine in Los Angeles, California before
moving to Atlanta, Georgia. [Tr. 331].
C. Brunswick Wellness Center
Dr. Enmon began working at Brunswick Wellness Center in
Brunswick, Georgia ("BWC") on approximately May 2, 2011. [Tr. 308,
183]. Respondent testified about his employment at BWC. I find this
portion of his testimony credible and consistent with the evidence
in the record. A staffing company recruited Dr. Enmon to work at
BWC. [Tr. 334, 182]. Upon his arrival at BWC, Dr. Enmon testified
that the clinic did not appear to be a normal doctor's office. [Tr.
334]. There, Dr. Enmon met with BWC's office manager, a woman who,
according to Dr. Enmon's testimony, appeared to be under the
influence of controlled substances. [Id., 343].
Dr. Enmon further testified that he was "not comfortable" with
several elements of BWC's operation. [Tr. 339]. Specifically,
Respondent claimed that BWC's management directed him to treat out-
of-state patients and patients under twenty-five years old, even
though he initially refused to treat these kinds of patients. [Id.].
According to Dr. Enmon, he realized that continued employment at BWC
placed him "at risk" and in fact spurred him to open his own
chronic pain management clinic. [Tr. 340, 343]. While Dr. Enmon
testified at length about his concerns about BWC's operation, he
also testified that "a lot" of Brunswick's patients were in fact
"legitimate" pain patients. [Tr. 335].
D. Search Warrant Served on Brunswick Wellness Center on July 14,
2011
On July 12, 2011, a federal search and seizure warrant was
issued against Brunswick Wellness Center. [Govt. Exh. 8; Tr. 16-17].
A team of local and federal law enforcement agents executed the
warrant on July 14, 2011 at 10:00 a.m. [Tr. 181]. DI Sikes was a
member of the law enforcement team that executed the warrant. [Id.].
DI Sikes interviewed Dr. Enmon during the execution of the
search warrant. [Tr. 181]. At the time of the search warrant's
execution, Dr. Enmon was the only physician employed by BWC. [Tr.
183]. Dr. Enmon admitted to DI Sikes that while he had no
specialized training in pain management, he was practicing as a pain
management doctor at BWC. [Tr. 182]. Respondent further stated that
he practiced non-interventionist pain management, which he explained
as concentrating in medication management for chronic pain patients.
[Tr. 184]. Dr. Enmon also admitted to prescribing oxycodone and
hydromorphone products to BWC patients for pain management. [Id.].
Dr. Enmon informed DI Sikes that he saw between thirty-five and
forty patients a day at BWC, although he also disclosed that his
patient load was starting to increase due to the closure by law
enforcement of several neighboring pain clinics. [Tr. 185]. Dr.
Enmon charged his patients three hundred and fifty dollars per
visit. [Id.]. BWC did not accept insurance or other forms of
payments besides cash. [Id.].
DEA Special Agent Michael Marbert also participated in the
execution of the search warrant on BWC. [Tr. 213-214]. I find his
testimony credible and consistent with the documentary evidence in
the record. He interviewed two employees of BWC, a security guard,
and a phlebotomist. [Tr. 215]. The phlebotomist told SA Marbert that
BWC lacked basic medical equipment, like a defibrillator, tongue
depressors, and thermometers. [Tr. 218]. The security guard reported
that BWC attracted patients from Tennessee and Kentucky and that
many of the patients did not appear to show any signs of being in
pain. [Tr. 219]. Following the execution of the search warrant,
BWC's business license was revoked and it ceased to operate after
July 14, 2011. [Tr. 187].
E. Ocean Care Clinic
Following the closure of BWC, Dr. Enmon opened his own pain
management clinic, Ocean Care, in Jesup, Georgia on August 15, 2011.
[Tr. 187-188]. Ocean Care was located at 129 South Macon Street in
Jesup, Georgia, about thirty-eight miles from BWC. [Id.]. Respondent
was the sole owner of Ocean Care. [Tr. 188].
Linda Henderson, Ocean Care's office manager testified at the
hearing. [Tr. 265]. Ms. Henderson was a patient of Dr. Enmon while
he worked at BWC. [Tr. 266]. She testified that Dr. Enmon help to
wean her off pain medication that previous doctors at BWC had
prescribed for her. [Id.]. I do not find her testimony credible on
this point in light of Ms. Henderson's testimony on cross-
examination regarding the specific prescriptions that Dr. Enmon
issued to her while at BWC and Ms. Henderson's ScriptSure records.
[Tr. 313-316; Govt. Exh. 33].
Ms. Henderson also testified about the operation of Ocean Care.
[Tr. 271]. I find this portion of her testimony credible and
consistent with the evidence in the record. She testified that Ocean
Care did not treat out of state patients. [Tr. 272-273]. Ocean Care
also required that patients be at least twenty-five years old and
possess a Georgia state ID. [Tr. 273, 276]. Ms. Henderson further
testified that Ocean Care denied treatment to approximately thirty
to sixty patients every day. [Tr. 274]. Ocean Care had patients come
in for pill counts. [Tr. 278-279, 288]. Ocean Care also did not
advertise and relied solely on word of mouth to attract new
patients. [Tr. 292]. During Ocean Care's operation from August to
December 2011, Dr. Enmon treated over nine hundred patients. [Tr.
324]. Some of these Ocean Care patients also received treatment from
Dr. Enmon while he was employed at BWC. [Tr. 325].
DI Sikes further testified about a complaint he received from a
local hospital regarding one of Dr. Enmon's Ocean Care patients.
[Tr. 371]. This patient, M.B.S., presented complaints of abdominal
pain but the admitting physician at the hospital determined that she
was in fact suffering from opiate-induced constipation. [Tr. 371-
372; Govt. Exh. 7 at 3]. Concerned about Respondent's treatment of
M.B.S., a patient whom the admitting physician diagnosed as opiate
dependent, the admitting physician had M.B.S.'s treatment records
faxed to the DEA and asked DI Sikes to investigate Dr. Enmon. [Tr.
373, 376-77, 380-381; Govt. Exh. 7].
F. Search Warrant Served on Ocean Care Clinic on October 6, 2011
On October 5, 2011, a federal search and seizure warrant was
issued against Ocean Care. [Govt. Exh. 9]. A team of local and
federal law enforcement agents executed the warrant on October 6,
2011. [Tr. 188]. DI Sikes was a member of the law enforcement team
that executed the warrant. [Id.]. Six employees and Respondent were
present at Ocean Care during the execution of the warrant. [Tr.
189].
DI Sikes interviewed Dr. Enmon during the execution of the
search warrant at Ocean Care. [Id.]. Dr. Enmon told DI Sikes that he
was the sole owner of Ocean Care and had opened the clinic on August
15, 2011. [Tr. 189-190]. Respondent informed DI Sikes that Ocean
Care required potential patients to produce a Georgia ID, be at
least twenty-five years old, and have a MRI or CT scan record prior
to receiving treatment at the clinic. [Tr. 191].
Dr. Enmon also told DI Sikes that he saw between twenty and
forty patients a day and that Ocean Care drew patients from a number
of surrounding pain clinics including the
[[Page 57118]]
shuttered Brunswick Wellness Center. [Tr. 191-192]. Patients paid
two hundred and seventy-five dollars per visit and Ocean Care only
accepted payment in cash or money orders. [Tr. 194]. Respondent
further stated that Ocean Care possessed medical equipment ranging
from a scale and stethoscope to a blood pressure cuff but lacked
gloves, Band-Aids, a defibrillator, first aid kit, tongue
depressors, cotton balls, gauze and a thermometer. [Tr. 193-194].
With regard to his prescribing practices, Respondent admitted to
issuing prescriptions to Ocean Care patients for fifteen and thirty
milligram dosage units of Roxicodone, a schedule II controlled
substance, and for two milligram dosage units of Xanax, a schedule
IV controlled substance. [Tr. 192]. Respondent typically issued
prescriptions for between one hundred and twenty to one hundred and
fifty dosage units of thirty milligram Roxicodone and between thirty
and ninety dosage units for fifteen milligram Roxicodone. [Tr. 192-
193]. Respondent also typically issued prescriptions for thirty
dosage units of two milligram Xanax. [Tr. 193].
Following the execution of the search warrant, SA Marbert
conducted interviews with several Ocean Care patients. [Tr. 236-
237]. One patient told SA Marbert that he obtained controlled
substances prescriptions from Dr. Enmon in order to sell them on the
street. [Tr. 240]. The patient further reported that Dr. Enmon did
not perform a physical examination prior to writing the
prescriptions and was able to have the dosage units of his
prescriptions increased upon request. [Id.].
G. DEA's December 8, 2011 Letter to Dr. Enmon
On December 8, 2011, Dr. Enmon called DI Sikes and inquired
about the status of his renewal for his DEA certificate of
registration. [Tr. 196-197]. DI Sikes informed Dr. Enmon that he
could no longer handle controlled substances because he was working
from an unregistered location. [Tr. 197]. DI Sikes also asked to
meet with Dr. Enmon to provide him with a letter from the DEA's
Chief Counsel's Office regarding the status of his registration.
[Tr. 199].
On December 9, 2011, Dr. Enmon was personally served with this
letter at the DEA office in Savannah, Georgia. [Tr. 199; Govt. Exh.
4]. This letter instructed Dr. Enmon that he was without the
necessary authority to handle controlled substances at his practice
location, the Ocean Care Clinic because the DEA had not approved the
address change request he had submitted on August 31, 2011.\1\
[Govt. Exh. 4]. After receiving this letter, Dr. Enmon closed the
Ocean Care Clinic and ceased issuing prescriptions for controlled
substances from this location. [Tr. 202, 301].
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\1\ The Respondent never filed an application to change his DEA
registration from Atlanta to the Brunswick Wellness Center. [Tr.
180-181].
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H. Patient Files
On October 6, 2011, DI Sikes, using a federal search warrant,
obtained over nine hundred patient treatment files from the Ocean
Care Clinic.\2\ [Tr. 19-22; Govt. Exh. 9]. A random sampling of
these patient files were provided to the Government's expert medical
witness, Dr. Eugene Kennedy. [Tr. 21, 23-24]. Dr. Kennedy reviewed
forty patient files from the Ocean Care Clinic. [Tr. 155-156]. A
total of nineteen of these patient files were admitted into the
record in this proceeding. [Govt. Exh. 12-30].
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\2\ The patient files and testimony about those files are
protected by a Protective Order in this proceeding. [ALJ Exh. 6].
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Dr. Kennedy testified at the hearing concerning these nineteen
patient files and his medical report. [Tr. 27; Govt. Exh. 6]. I
qualified Dr. Kennedy as an expert medical witness in "the use of
controlled substances for pain management and the use of
benzodiazepines." [Tr. 59]. Correspondingly, I find his testimony
credible and consistent with the documentary evidence in the record.
Dr. Kennedy, a board certified family practitioner, is licensed
to practice medicine in Georgia. [Tr. 31-33; Govt. Exh. 31]. While
Dr. Kennedy is not board certified in pain management, he is a
credentialed member of the American Academy of Pain Medicine. [Tr.
59; Govt. Exh. 31]. He has taken the required courses and test to
qualify for this credential. [Tr. 32-33]. He has a private practice
where he treats chronic pain patients, and for about seventy-five
percent of his patients, he issues controlled substance
prescriptions in order to manage their pain treatment. [Tr. 34-35,
39]. Dr. Kennedy sees fourteen to fifteen patients a day. [Tr. 39].
According to Dr. Kennedy, a patient load of forty patients a day
qualifies as a heavy patient load. [Tr. 39].
Prior to treating a chronic pain patient, Dr. Kennedy requires
the patient or referring physician to provide the patient's past
medical records. [Tr. 40]. Dr. Kennedy only sees such patients on a
referral basis. [Id.]. He requires "a very solidly established
medical history--usually surgical history--that would support" the
medical necessity for treating a patient with long-term narcotics.
[Id.]. Dr. Kennedy testified that a physical examination is a
necessary requirement in order to properly treat a chronic pain
patient. [Tr. 41]. Dr. Kennedy will first explore nonpharmacologic
options with the patient before considering prescribing medication.
[Tr. 42]. Dr. Kennedy next will look to non-narcotic medications,
and after exploring these options, will begin treating the patient
incrementally with narcotic medications. [Tr. 43]. Dr. Kennedy
credibly testified that he "would have to have substantial support
from previous treating physicians before I would put someone on
chronic narcotics." [Id.]. Dr. Kennedy further credibly testified
that every patient in his practice has a urine drug screen before
they get their first prescription, and that urine drug screens are
done randomly thereafter to ensure the patient is taking the
controlled substances as prescribed. [Tr. 44].
Xanax is a brand name for alprazolam, a schedule IV controlled
substance. [Tr. 45; Govt. Exh. 11]. It is chemically classified as a
benzodiazepine and is commonly prescribed as an anti-anxiety drug.
[Tr. 45-46; Govt. Exh. 11]. Dr. Kennedy credibly testified that
before prescribing Xanax to a patient, he would need "substantial
documentation as to what their symptomatology is, how long it has
lasted, how it is affecting their life, and why it's necessary for
me to treat them with scheduled medications." [Tr. 68-69].
Specifically, he noted that the patient's file should contain a
"specific anxiety diagnosis" with a detailed description of their
current symptoms, past medical treatment, and their social history.
[Tr. 123].
Klonopin is a brand name for clonazepam, which is another
Schedule IV controlled substance. [Tr. 46; Govt. Exh. 10]. It is
also a benzodiazepine, and is commonly prescribed for use as a
muscle relaxant. [Tr. 46-47]. Dr. Kennedy credibly explained, "I
would want to establish that the patient has either failed or has
not done well on any of the plethora of non-scheduled non-controlled
muscle relaxants and anti-spasmodics that are available" before
issuing a prescription for Klonopin. [Tr. 47].
1. D.B.
D.B., a patient at Respondent's Ocean Care Clinic, was diagnosed
with neck and low back pain. [Tr. 62; Govt. Exh. 12]. His patient
file contains an MRI report, but Dr. Kennedy found that "the report
alone does not support prescribing narcotic medication." [Tr. 62;
Govt. Exh. 6 at 2]. Dr. Kennedy stated that the Respondent would
need a supporting physical examination because the MRI findings were
not severe enough to support prescribing narcotics. [Tr. 62-63;
Govt. Exh. 6 at 2]. Further, Dr. Kennedy found that there was
nothing in D.B.'s patient file that justified the amount and
strength of narcotics that were prescribed to D.B. [Tr. 63-64; Govt.
Exh. 12]. Although D.B. indicated that he had long-term pain, there
were no previous medical treatment records in D.B.'s chart, despite
the listing of a previous prescribing physician. [Tr. 64-65; Govt.
Exh. 12 at 19, 21]. Although D.B. reported that his "left
fingertips stay numb," Dr. Kennedy could not find anything that
would support such a symptom in D.B.'s medical chart. [Tr. 65; Govt.
Exh. 12 at 21].
Given what little medical examination that was provided, Dr.
Kennedy found that, "with full range of motion" and "normal
neurologic exam," the Respondent had failed to find a basis to
"support prescribing a large number of scheduled medications" for
D.B. [Tr. 66; Govt. Exh. 12 at 2]. Yet the Respondent prescribed one
hundred and twenty dosage units of 30 milligram Roxicodone, sixty
dosage units of 15 milligram Roxicodone, sixty dosage units of 2
milligram Xanax and sixty dosage units of 350 milligram Soma to D.B.
[Govt. Exh. 12 at 3-7]. Instead of issuing these prescriptions, Dr.
Kennedy opined that the Respondent should have tried "all medical
reliefs that are available before embarking on a course of large
dosages of narcotics, to include non-scheduled medications and
lifestyle changes, diet, exercise, heat applications, physical
therapy, [and] possibly injections." [Tr. 67]. Attempting to pursue
these other options would be the standard of care. [Tr. 67].
Dr. Kennedy further found that the patient's file lacked the
degree of information needed to support the prescribing of Xanax.
[[Page 57119]]
[Tr. 68-69; Govt. Exh. 12 at 27; Govt. Exh. 6 at 1-3]. Dr. Kennedy
credibly testified that he would expect to see "questions and
responses that are significant enough to support assigning a patient
a psychiatric diagnosis and prescribing controlled medications"
prior to issuing a prescription for Xanax [Tr. 171]. Further, the
file contained no mention of any actual plan of treatment. [Govt.
Exh. 6 at 2]. Overall, Dr. Kennedy found that the "treatment of
this patient falls below the standard of care."\3\ [Govt. Exh. 6 at
2-3].
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\3\ Dr. Kennedy credibly testified that his assessment of the
patient files in this matter was based on the Georgia standard of
care. [Tr. 165].
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2. T.C.
T.C.'s patient file contained a thoracic MRI report, which was
essentially normal. [Tr. 69; Govt. Exh. 13 at 8]. Dr. Kennedy
described the accompanying lumbar impressions as "very minor," and
in Dr. Kennedy's opinion, these lumbar impressions did not "rise to
the level of starting the patient on large dose narcotics." [Tr.
69-70]. In addition, T.C.'s patient chart indicated that there was
no past medical history, no past surgical history, and no family
medical history. [Tr. 72-73; Govt. Exh. 13 at 1]. Dr. Kennedy found
that this lack of self-reported medical history "does not support
prescribing scheduled medications." [Tr. 73]. Further, there is no
mention of anxiety in the file, and thus, the prescribing of Xanax
is not justified by this medical record. [Tr. 73]. In sum, Dr.
Kennedy found that there was "no documentation to support pain that
rises to the level of requiring the agents prescribed." [Govt. Exh.
6 at 4].
As for prescribing, Dr. Kennedy found that the Respondent
"inappropriately initially prescribed schedule II opiates and other
scheduled medications in the absence of an appropriate supporting
history and physical examination. The rationale for prescribing
narcotics was never mentioned." [Govt. Exh. 6 at 5]. In addition,
Dr. Kennedy found that the record fails to document "any treatment
modalities attempted in the past or anticipated for the future."
[Id.]. The chart also fails to reflect any plan of treatment. [Id.].
Further, a "coherent rationale for the treatment of this patient is
absent entirely." [Id.]. Dr. Kennedy likewise found that a
pertinent physical examination was never performed. In conclusion,
Dr. Kennedy credibly opined that the "treatment of this patient
falls below the standard of care in almost every regard." [Id.]. He
further noted that on the single, initial encounter, "this patient
was provided with prescriptions that resulted in a combined total of
290 pills. In my opinion, this patient's management is unacceptable,
and falls below any reasonable standards of care." [Id.].
3. J.D.
J.D.'s patient file contained a MRI report for the patient's
cervical and thoracic spine. [Tr. 74; Govt. Exh. 14 at 19-20].
Although the patient reported having scoliosis as a teenager, the
MRI report does not support this claim. [Tr. 75; Govt. Exh. 14 at
19-20]. Dr. Kennedy opined that the findings in the MRI report were
"minimal" and "do not support large doses of narcotic
medication." [Tr. 75; Govt. Exh. 6 at 8]. And although the patient
noted two prior treating physicians, the patient file does not
contain any previous medical records or any indication that these
previous medical records were requested by Ocean Care. Dr. Kennedy
opined that such records should have been requested. [Tr. 75-76].
J.D. also reported that she had previously been prescribed
Lorcet.\4\ [Govt. Exh. 14 at 8]. However, the Respondent prescribed
Roxicodone, a schedule II controlled substance to J.D. [Govt. Exh.
14 at 17]. Dr. Kennedy opined that there were no notations in the
patient file that would support increasing the strength of the
opiate prescribed to J.D. [Tr. 76]. Rather, Dr. Kennedy noted that
more "conservative, non-scheduled treatments would have been
appropriate for this patient." [Id.]. Also, the patient file failed
to indicate any reason for prescribing Xanax other than a check-mark
beside the word "anxiety" on the physical examination form. [Govt.
Exh. 6 at 8]. Lastly, no treatment plan is reflected in this file.
[Govt. Exh. 14].
---------------------------------------------------------------------------
\4\ Lorcet is the brand name for combination hydrocodone and
Tylenol, a schedule III controlled substance. [Tr. 76].
---------------------------------------------------------------------------
Dr. Kennedy credibly opined that a "coherent rationale for the
treatment of this patient is absent entirely." [Govt. Exh. 6 at 8].
Further, he noted that the "unsupported coadministration of
oxycodone, Xanax and Soma could represent a significant risk to the
patient. It should be noted that on the single, initial encounter,
this patient was provided with prescriptions that resulted in a
combined total of 330 pills. In my opinion, this patient's
management is unacceptable, and falls below a reasonable standard of
care." [Govt. Exh. 6 at 9].
4. L.D.
L.D.'s patient file contains a blank physical examination sheet,
indicating that no physical exam was performed. [Tr. 80; Govt. Exh.
15 at 3-4]. The patient self-reported that he had never been
prescribed pain medication in the past. [Tr. 81; Govt. Exh. 15 at
19]. Dr. Kennedy opined that the prescriptions written to L.D. were
not supported by the physical examination. [Tr. 81; Govt. Exh. 6 at
10-11]. The patient file likewise failed to provide a medical
justification for the Xanax prescription that Respondent issued to
L.D. [Tr. 82]. Dr. Kennedy also noted that there was "no mention of
any treatment modalities attempted in the past or anticipated for
the future. There is no documentation in the chart that indicates
any actual plan of treatment or supports any rationale for
prescribing controlled medication." [Govt. Exh. 6 at 10-11].
Overall, Dr. Kennedy concluded that the treatment of this
patient fell "below an acceptable standard of care." [Id.]
Specifically, Dr. Kennedy found that "nowhere in the medical record
is there any evidence that even a cursory physical examination was
ever performed" and that "this patient was provided with
prescriptions that resulted in a combined total of 300 pills, and
this was repeated on the subsequent encounter. In my opinion, this
patient's management is entirely unacceptable, and falls below every
reasonable standard of care." [Govt. Exh. 6 at 11-12].
5. A.J.
A.J.'s patient file listed a previous treating family physician,
but the Ocean Care file does not contain any previous medical
records from this physician. [Tr. 82; Govt. Exh. 16]. A.J. self-
reported receiving prior prescriptions for oxycodone and Xanax. [Tr.
84; Govt. Exh. 16 at 8, 20]. Yet the patient file failed to provide
any other medical history that would verify this information. [Tr.
84]. This patient file also contained a blank follow-up physical
examination form with only the patient's blood pressure and heart
rate recorded. [Tr. 84; Govt. Exh. 16 at 1]. Dr. Kennedy credibly
testified that he would expect to see the complete vital signs for
each patient visit to Dr. Enmon's clinic. [Tr. 84-85].
Although A.J. reported experiencing a pain level of nine and
ten, the maximum indications available on the form, there is no
medical information in the patient record that would support this
report of such high levels of pain. [Tr. 85-86; Govt. Exh. 6 at 13].
A.J. also reported that her pain location was "everywhere." [Govt.
Exh. 16 at 28]. Dr. Kennedy found that a patient with that reported
level of pain and that location of pain "would have credibility
problems," because such reports would be unbelievable. [Tr. 86].
Likewise, A.J.'s patient file does not contain any information
concerning a complaint or diagnosis of anxiety, but Respondent
nevertheless issued her a prescription for Xanax. [Tr. 86; Govt.
Exh. 16]. Dr. Kennedy concluded that this prescription for Xanax was
not issued for a legitimate medical purpose in the course of
professional practice. [Tr. 86-87; Govt. Exh. 6 at 14].
Dr. Kennedy also found that there was no mention of any
treatment modalities "attempted in the past or anticipated for the
future. There is no documentation in the chart that indicates any
actual plan of treatment or supports any rationale for prescribing
controlled medication." [Govt. Exh. 6 at 14]. He also opined that
the "treatment of this patient falls below an acceptable standard
of care." [Id. at 14-15]. On A.J.'s first visit to Ocean Care,
Respondent provided her with prescriptions for scheduled medications
that "resulted in a combined total of 240 pills, and this was
repeated on the subsequent encounter." [Id.]. Overall, Dr. Kennedy
found that "this patient's management [was] unacceptable, and [it
fell] below a reasonable standard of care." [Govt. Exh. 6 at 15].
6. B.B.
BB's patient file contained a physical examination form that is
blank except for a check marked notation that B.B. "appears in
pain." [Govt. Exh. 17 at 11]. There are no other physical
examination entries. [Id.]. The patient file contained an MRI
report, but Dr. Kennedy credibly opined that the lack of a detailed
physical examination coupled with the inconclusive MRI report, fails
to medically support the prescribing of Roxicodone in the amounts
and strengths that the Respondent prescribed to B.B. [Tr.
[[Page 57120]]
88; Govt. Exh. 17 at 2-5; Govt. Exh. 6 at 16-17]. Additionally, the
patient's MRI report identified a referring physician, and Dr.
Kennedy opined that Dr. Enmon should have acquired the patient's
previous medical records. [Tr. 89-90; Govt. Exh. 6 at 16]. No
previous medical records were present in the patient's Ocean Care
file. [Tr. 90; Govt. Exh. 17]. Dr. Kennedy further noted that B.B.'s
patient file did not contain any entries that would support the
prescribing of Xanax to this patient. [Tr. 90-91; Govt. Exh. 17 at
26; Govt. Exh. 6 at 17].
Dr. Kennedy also noted that there was "no mention of any
treatment modalities attempted in the past or anticipated for the
future." [Govt. Exh. 6 at 17]. B.B.'s patient file also did not
contain a treatment plan. [Id.]. However, the patient was provided
with prescriptions for a combined total of three hundred and ninety
pills. [Id.]. In Dr. Kennedy's expert medical opinion, "this
patient's management [was] unacceptable, and [fell] below a
reasonable standard of care, and may represent a significant danger
to the patient's safety." [Id.].
7. J.B.
J.B.'s patient file contained a follow-up examination form,
which was blank except for a notation of J.B.'s pulse and blood
pressure. [Govt. Exh. 18 at 1]. Dr. Kennedy found this significant,
for he credibly testified: "There is no way of knowing what the
patient's follow-up complaint status was. There's no way to tell
what the physician intended. There is certainly no support for
ongoing narcotics medication." [Tr. 92; Govt. Exh. 6 at 20].
Dr. Kennedy also found that J.B.'s patient file did not contain
adequate entries to justify a diagnosis of chronic anxiety. [Tr.
94]. Therefore, he found that Xanax was not appropriate to prescribe
based upon the entries in this patient file. [Tr. 94; Govt. Exh. 6
at 20]. Further, the patient file does not contain information that
justified the prescribing of scheduled narcotics. [Tr. 95]. To this
point, Dr. Kennedy explained that the patient file failed to note
any treatment modalities attempted in the past or anticipated for
the future. [Govt. Exh. 6 at 20]. He also pointed out that
Respondent's treatment plan for J.B. was not recorded in the patient
file. [Id.]. Overall, Dr. Kennedy found that "this patient's
management [was] unacceptable, and [fell] below a reasonable
standard of care, and may represent a significant danger to the
patient's safety." [Govt. Exh. 6 at 20-21].
8. A.A.
Dr. Kennedy found that Respondent's treatment of this patient
"achieve[d] an acceptable standard of care, although barely." [Tr.
96; Govt. Exh. 6 at 23]. Specifically, Dr. Kennedy noted that the
Respondent's initial management of A.A. with opiates was acceptable,
and "giving both the patient and the [Respondent] the benefit of a
doubt, minimally achieves a reasonable standard of care." [Govt.
Exh. 6 at 24]. A.A.'s patient file demonstrated that she had a
history of multi-level spine surgeries, and the MRI report supported
her account. [Tr. 96]. Entries in the physical examination of
surgical scarring and tenderness, and uncomfortable range of motion
were also consistent with a history of these types of surgeries.
[Tr. 96; Govt. Exh. 19 at 1-2].
But Dr. Kennedy testified that A.A.'s patient file did not
support the prescribing of Xanax to this patient. [Tr. 97; Govt.
Exh. 6 at 23]. He further noted that the patient file failed to
reflect any other treatment modalities in the past or anticipated
for the future. [Govt. Exh. 6 at 23]. Lastly, he found that the
patient file did not contain a treatment plan for A.A. [Id.].
9. N.A.
This patient reported experiencing chronic pain resulting from
an acute injury. [Tr. 98; Govt. Exh. 20 at 14, 16]. Yet N.A.'s MRI
report does not support a history of traumatic injury. [Tr. 98-99;
Govt. Exh. 20 at 9, 11]. N.A.'s patient file contained a history and
physical examination form, but the physical examination portion of
the form is largely blank except for notations of the patient's
height, weight, blood pressure and pulse measurements. [Tr. 100;
Govt. Exh. 20 at 1]. N.A. reported seeing a prior treating
physician, but N.A.'s prior medical records were not present in the
Ocean Care patient file for N.A. [Tr. 99; Govt. Exh. 20].
Given the largely blank physical examination form and the
unremarkable MRI report, Dr. Kennedy concluded that there was no
documented support in the patient file to justify prescribing
Roxicodone to N.A. [Tr. 98, 100; Govt. Exh. 6 at 25]. Specifically,
he found that the Respondent issued prescriptions for a total of two
hundred and ninety scheduled pills even though the "rationale for
prescribing narcotics was never mentioned" in the patient file.
[Govt. Exh. 6 at 26]. Additionally, there was no mention of any past
or future treatment modalities, and N.A.'s patient file also did not
contain a treatment plan. [Id.].
N.A. self-reported symptoms of anxiety and panic attacks. [Govt.
Exh. 20 at 25]. Yet her patient file provided no other diagnostic
information or medical history relating to these claimed symptoms.
[Govt. Exh. 20]. Dr. Kennedy found that, under these circumstances,
the Xanax prescription issued to N.A. was not for a legitimate
medical reason in the usual course of practice. [Tr. 101-102]. Dr.
Kennedy concluded that N.A.'s "management [was] unacceptable,
[fell] below a reasonable standard of care, and may represent a
significant danger to the patient's safety." [Govt. Exh. 6 at 26-
27].
10. S.A.
S.A.'s patient file contained a completed release of information
form for the patient's prior treating physician. [Govt. Exh. 21 at
1]. But S.A.'s patient file does not contain any prior medical
records from this physician. [Tr. 103; Govt. Exh. 21]. Dr. Kennedy
testified that he would expect to see prior medical records before
prescribing oxycodone at the levels this patient was prescribed.
[Tr. 103]. Furthermore S.A.'s history and physical examination form,
except for vital signs and a notation that the sensory exam was
normal, is blank. [Tr. 103-104; Govt. Exh. 21 at 31]. Given the lack
of S.A.'s prior medical records and the incomplete physical
examination form, Dr. Kennedy concluded that the controlled
substances prescriptions issued by Dr. Enmon to this patient were
not for a legitimate medical purpose. [Tr. 104; Govt. Exh. 6 at 29].
S.A.'s patient file also contains a prescription record that
shows her previous treating physician wrote S.A. a prescription for
Methylin, a schedule II controlled substance and amphetamine. [Govt.
Exh. 21 at 15]. Dr. Enmon issued S.A. a prescription for Xanax but
Dr. Kennedy explained that he would have explored whether S.A.'s
anxiety was caused by the Methylin. [Tr. 105]. Yet the patient file
did not demonstrate such an inquiry or any other information to
justify the Xanax prescription. [Tr. 105]. Furthermore, Dr. Kennedy
noted that the patient file failed to note any past or future
treatment modalities, or an actual plan of treatment for S.A. [Govt.
Exh. 6 at 29]. However, over two visits to Ocean Care, this patient
was prescribed five hundred and twenty scheduled pills. Dr.
Kennedy's overall opinion was that "this patient's management [was]
unacceptable, [fell] below a reasonable standard of care, and may
represent a significant danger to the patient's safety." [Govt.
Exh. 6 at 30].
11. M.G.
M.G. self-reported that he was taking "Roxy" and "Loreys,"
which are slang names for Roxicodone and Lorcet. [Govt. Exh. 22 at
20; Tr. 106]. Dr. Kennedy testified that a patient's use of street
names for pain medications would concern him. [Tr. 106]. Dr. Kennedy
also noted that although M.G. identified a prior treating physician,
M.G.'s patient file did not contain any prior medical records.
[Govt. Exh. 22 at 19, 21].
Dr. Enmon's physical examination of M.G. produced "essentially
normal" findings, although Respondent noted some mild tenderness in
the patient's cervical spine. [Govt. Exh. 22 at 2; Tr. 107].
Although the patient file contained a cervical MRI report, Dr.
Kennedy credibly testified that this data alone would not justify
the issuance of the strengths and amounts of oxycodone prescribed by
the Respondent. [Tr. 108-109; Govt. Exh. 22 at 11]. Nor would the
results of M.G.'s physical examination justify the level of
narcotics the Respondent prescribed for this patient. [Tr. 107-108;
Govt. Exh. 22 at 2; Govt. Exh. 6 at 31-32]. Additionally, although
the patient self-reported experiencing anxiety and panic attack
symptoms, again Dr. Kennedy found no medical justification for
issuing M.G. a Xanax prescription. [Tr. 108; Govt. Exh. 22 at 29;
Govt. Exh. 6 at 32]. In summary, Dr. Kennedy surmised that "this
patient's management [was] unacceptable, [fell] below a reasonable
standard of care, and may represent a significant danger to the
patient's safety." [Govt. Exh. 6 at 33].
12. J.G.
Respondent's physical examination of J.G. produced "essentially
normal" findings although Dr. Enmon noted that the patient appeared
to be in pain along with some moderate paraspinal tenderness. [Tr.
109; Govt. Exh. 23 at 2]. Dr. Kennedy testified that J.G.'s physical
exam and MRI report do not medically justify the prescription
Respondent issued to J.G. for oxycodone. [Tr. 109-110; Govt. Exh. 6
at 34-35].
[[Page 57121]]
Additionally, J.G.'s patient file documented no past medical
history or surgical history for this patient. [Tr. 109; Govt. Exh.
23 at 1]. Although the patient listed receiving treatment from
another pain clinic, J.G.'s patient file does not contain any
records from that clinic. [Govt. Exh. 23 at 15-16; Tr. 110]. Dr.
Kennedy testified that Respondent should have acquired these prior
records before prescribing the quantity of oxycodone issued to this
patient. [Tr. 110-111]. Furthermore, Dr. Kennedy found that J.G.'s
patient file failed to contain any mention of past or future
treatment modalities or a treatment plan. [Govt. Exh. 6 at 35].
J.G. denied experiencing any anxiety or panic attack symptoms,
but Respondent nevertheless issued J.G. a prescription for Xanax.
[Tr. 111; Govt. Exh. 23 at 24]. Dr. Kennedy credibly testified that
this prescription was "not medically legitimate." [Tr. 111].
J.G.'s patient file provided no justification for the Xanax
prescription. [Tr. 111; Govt. Exh. 23; Govt. Exh. 6 at 35]. In
conclusion, Dr. Kennedy found that "this patient's management [was]
unacceptable, [fell] below a reasonable standard of care, and may
represent a significant danger to the patient's safety." [Govt.
Exh. 6 at 35-36].
13. T.G.
T.G. reported lower back pain stemming from a car accident in
which she was ejected from the vehicle. [Govt. Exh. 24 at 4-5].
Despite this serious car accident and T.G.'s listing of a prior
treating physician, T.G.'s patient file did not contain any prior
medical records. [Govt. Exh. 24 at 6; Tr. 112]. Dr. Kennedy also
found that the MRI report and physical examination findings for T.G.
did not support the medications prescribed by Respondent. [Tr. 112;
Govt. Exh. 6 at 37]. Specifically, he opined that T.G. should have
been treated with "non-scheduled modalities, even non-pharmacologic
modalities initially prior to advancing to providing 300 narcotics
pills." [Tr. 112]. In addition, Dr. Kennedy found that T.G.'s
patient file failed to note any past or anticipated treatment
modalities, or provide any actual treatment plan for the patient.
[Govt. Exh. 6 at 38]. Lastly, Dr. Kennedy credibly testified that
there was no information in the patient file that would justify the
Xanax prescription issued to T.G. by the Respondent. [Tr. 114; Govt.
Exh. 6 at 38]. T.G. did not report experiencing any anxiety
symptoms. [Govt. Exh. 24 at 14; Tr. 114]. In Dr. Kennedy's expert
medical opinion, "this patient's management [was] unacceptable,
[fell] below a reasonable standard of care, and may represent a
significant danger to the patient's safety." [Govt. Exh. 6 at 38-
39].
14. A.J.
A.J. lacerated his left thumb while uninstalling a countertop.
[Govt. Exh. 25 at 5]. Prior to seeking treatment at Ocean Care, A.J.
had been treated at a hospital emergency room and an urgent care
clinic where he had been prescribed Lorcet, a schedule III
controlled substance. [Tr. 115; Govt. Exh. 25 at 5-7]. Respondent
issued A.J. a prescription for ninety dosage units of thirty
milligram Roxicodone and sixty dosage units of two milligram Xanax.
[Govt. Exh. 25 at 20-21, 24]. Dr. Kennedy found that the Roxicodone
was "inappropriately prescribed" to A.J. because Dr. Enmon did not
document or justify increasing the amounts and strength of scheduled
medications necessary to treat A.J.'s pain symptoms. [Tr. 116; Govt.
Exh. 6 at 41]. To that point, Dr. Kennedy noted that while A.J.
self-reported pain in the arm, back and neck, in addition to the
thumb pain, there was no documentation in the patient file that
supported these claims. [Tr. 117; Govt. Exh. 25 at 6]. Nor did Dr.
Enmon document any examination of A.J.'s reported pain symptoms
outside of examining his left thumb. [Govt. Exh. 6 at 41]. A.J. also
reported that "almost anything" causes or increases his pain
level. [Govt. Exh. 25 at 11]. Dr. Kennedy highlighted that such a
nonspecific complaint would cause him to question the patient's
credibility. [Tr. 119].
Dr. Kennedy also found the prescription for Xanax was medically
illegitimate. [Tr. 118; Govt. Exh. 6 at 41]. While A.J. reported
experiencing anxiety symptoms, his patient file did not contain any
further information that would support these assertions. [Tr. 118;
Govt. Exh. 25 at 23]. Although A.J. reported that he was prescribed
Xanax for pain, Xanax is not a drug that is indicated for the
treatment of pain. [Tr. 119; Govt. Exh. 11].
Lastly, despite the indications that A.J. had recently received
treatment from both a hospital emergency room and an urgent care
clinic, his Ocean Care patient file did not contain any prior
medical records. [Govt. Exh. 25; Tr. 115]. Nor did his patient file
contain any mention of past or anticipated treatment modalities, and
there is no documentation in the file "that indicates a rationale
for prescribing ongoing controlled medication." [Govt. Exh. 6 at
41]. Thus, Dr. Kennedy concluded that Respondent's treatment of this
patient fell below an acceptable standard of care. [Govt. Exh. 6 at
42].
15. L.M.
L.M.'s patient file contained a history and physical examination
form, but the physical examination portion of the form is almost
entirely blank except for notations of the patient's height, weight,
blood pressure and pulse measurements. [Tr. 120; Govt. Exh. 26 at
2]. L.M. self-reported taking several controlled substances,
including oxycodone, Soma, Adderall, and Xanax, but Dr. Kennedy
found that his patient file failed to provide sufficient information
concerning L.M.'s need for these medications. [Tr. 121; Govt. Exh.
26 at 12]. In fact, L.M. reported that he was not currently under
the care of a physician. [Govt. Exh. 26 at 18]. Dr. Kennedy further
noted that L.M.'s prior medical records were not present in his
Ocean Care patient file. [Tr. 121; Govt. Exh. 26].
L.M. reported experiencing anxiety symptoms. [Govt. Exh. 26 at
24]. L.M. also reported taking Adderall, an amphetamine and Schedule
II controlled substance. [Tr. 122; Govt. Exh. 26 at 12]. Dr. Kennedy
testified that while L.M.'s Adderall use could have produced his
anxiety symptoms, Respondent ignored this possibility and instead
issued a Xanax prescription to L.M. [Tr. 122-123; Govt. Exh. 26 at
24]. Dr. Kennedy testified that prior to issuing a prescription for
Xanax, he would expect that the patient's file contain an anxiety
diagnosis based on specific and detailed documentation of the
patient's symptoms, psychosocial situation, and prior medical
treatment. [Tr. 123].
Furthermore, Dr. Kennedy explained that while prescriptions for
a total of three hundred and twenty scheduled pills and sixty dosage
units of Soma were provided to L.M., the "rationale for prescribing
narcotics was never mentioned. There is nothing in the chart that
even minimally supports the initial prescription of Xanax." [Govt.
Exh. 6 at 44]. Likewise, L.M.'s patient file failed to reflect any
past or anticipated treatment modalities, or provide a treatment
plan for the patient. [Id.]. Dr. Kennedy concluded that Respondent's
treatment of L.M. fell "below an acceptable standard of care."
[Id.].
16. S.M.
S.M.'s patient file contained a history and physical examination
form, but the physical examination portion of the form is blank
except for notations of the patient's height, weight, blood pressure
and pulse measurements. [Govt. Exh. 27 at 24; Govt. Exh. 6 at 46].
Dr. Kennedy also testified that S.M.'s MRI report showed that the
patient had only a "mild disc bulge and mild bilateral foraminal
stenosis," findings which do not "connote any neurological
impingement." [Tr. 125; Govt. Exh. 27 at 19]. Thus, Dr. Kennedy
concluded that S.M.'s physical examination and MRI report do not
justify the Roxicodone or Xanax prescriptions that Respondent issued
to this patient. [Tr. 124-25; Govt. Exh. 27 at 19; Govt. Exh. 6 at
47]. As Dr. Kennedy noted, there was no documented physical
examination in S.M.'s patient file to support any of his treatment.
[Tr. 126-27].
Nor did S.M.'s patient file contain any prior medical records,
despite the MRI report, which identified S.M.'s referring physician.
[Tr. 125; Govt. Exh. 27 at 19]. The patient file also failed to
record any treatment modalities or an actual plan of treatment for
S.M. [Govt. Exh. 6 at 47]. Consequently, Dr. Kennedy concluded that
"[t]he documentation present in the chart is inadequate to support
prescriptions for scheduled agents." [Id.]. Furthermore, S.M.
reported alcohol consumption and a previous DUI arrest. [Govt. Exh.
27 at 8]. Dr. Kennedy credibly testified that when a patient reports
a history with addictive substances, he "would be
mindful[hellip]when prescribing controlled medications" to that
patient. [Tr. 127]. Lastly, Dr. Kennedy found insufficient
justification in the patient file to support the prescribing of
Xanax to S.M. [Tr. 128; Govt. Exh. 6 at 47]. In conclusion, Dr.
Kennedy found that Respondent's treatment of S.M. fell "below an
acceptable standard of care." [Govt. Exh. 6 at 47-48].
17. K.M.
K.M.'s patient file contained a history and physical examination
form, but the physical examination portion of the form is blank
except for notations of the patient's height, weight, blood pressure
and pulse measurements and a checkmark indicating the patient
demonstrated normal posture. [Tr. 130; Govt. Exh. 28 at 25; Govt.
Exh. 6 at 49].
[[Page 57122]]
Dr. Kennedy also testified that findings from K.M.'s MRI report were
"fairly minimal." [Tr. 130; Govt. Exh. 28 at 20]. Thus, in Dr.
Kennedy's expert medical opinion, the patient's physical examination
and MRI report do not medically justify the prescriptions for
oxycodone, Lorcet and Xanax issued by Respondent to K.M. [Tr. 130;
Govt. Exh. 6 at 50]. Additionally, Dr. Kennedy testified that K.M.'s
report of high pain level is not credible in light of her MRI report
and physical examination. [Tr. 131-32; Govt. Exh. 28 at 5]. Nor did
K.M.'s patient file provide any medical justification for Respondent
issuing a Xanax prescription. [Tr. 132-33; Govt. Exh. 6 at 50].
The patient file also lacked any previous medical records other
than the MRI report despite the identification of a previous
treating clinic. [Tr. 132; Govt. Exh. 28 at 8]. Dr. Kennedy noted
that, if K.M. was being treated for chronic pain condition "that
rises to the level of requiring narcotics" he would expect "there
to be past medical records present in the chart." [Tr. 132]. In
addition, the patient file failed to list any treatment modalities,
either past or anticipated future modalities. [Govt. Exh. 6 at 50;
Govt. Exh. 28]. Nor did the patient file illustrate a treatment plan
for K.M. [Id.]. Lastly, Dr. Kennedy credibly opined that the
"documentation present in the chart is inadequate to support
prescriptions for scheduled agents" and that "[a] coherent
rationale for the treatment of this patient is completely absent."
[Govt. Exh. 6 at 50]. Thus, Dr. Kennedy concluded that Respondent's
treatment of this patient fell below an acceptable standard of care.
[Govt. Exh. 50-51].
18. E.L.
E.L. presented complaints of back and shoulder pain stemming
from a workplace related injury. [Govt. Exh. 29 at 5-9, 29]. After
reviewing the physical examination and the MRI report, Dr. Kennedy
credibly opined that those reports do not justify the quantity or
strength of opiates prescribed by the Respondent to this patient.
[Tr. 134-135; Govt. Exh. 29 at 19-20, 29-31]. Specifically Dr.
Kennedy noted that E.L.'s MRI report was "normal at all levels"
and did not document any "nerve impingement." [Tr. 135; Govt. Exh.
29 at 19-20]. Thus, Dr. Kennedy found that "the physical
examination alone [did not] support the diagnosis of a pain
condition that rises to the level of immediately pursuing schedule
II narcotic management." [Govt. Exh. 6 at 53]. Yet the Respondent,
over the course of two visits with this patient, prescribed three
hundred and sixty scheduled pills and one hundred and fifty dosage
units of Soma. [Id.] Dr. Enmon did not document his "rationale for
prescribing narcotics" to E.L. [Id.]. Likewise, Dr. Kennedy found
that E.L.'s patient file lacked any justification for the initial
prescription of Soma. [Id.]. Similarly, on E.L.'s follow-up visit,
both the oxycodone and the Lorcet were increased in quantity
"without explanation" by Respondent [Id.].
E.L. reported receiving hydrocodone and Roxicodone from prior
treating physician. [Govt. Exh. 29 at 5]. Yet his patient file does
not contain any prior medical records. [Govt. Exh. 29; Tr. 133]. Nor
does E.L.'s patient file reflect any past or anticipated future
treatment modalities, or a treatment plan. [Govt. Exh. 6 at 53-54].
In Dr. Kennedy's expert medical opinion, he found that Respondent's
treatment of E.L. fell "below an acceptable standard of care."
[Id.].
19. E.V.
EV presented complaints of neck and lower back pain. [Govt. Exh.
30 at 3-9]. Respondent issued E.V. a prescription for one hundred
and twenty dosage units of thirty milligram Roxicodone, sixty dosage
units of fifteen milligram Roxicodone, and ninety dosage units of
two milligram Xanax. [Govt. Exh. 30 at 24-25]. But Dr. Kennedy
testified that E.V.'s patient file contained a lumbar MRI report,
which was not consistent with the pain levels reported by E.V. [Tr.
136; Govt. Exh. 30 at 19-20; Govt. Exh. 6 at 55-56]. Similarly, Dr.
Kennedy testified that the findings on E.V.'s physical examination
did not medically justify the Roxicodone and Xanax prescriptions
issued to E.V. [Tr. 136-37; Govt. Exh. 30 at 25, 27; Govt. Exh. 6 at
55]. E.V. also did not report experiencing any anxiety symptoms, but
Respondent issued her a prescription for Xanax. [Govt. Exh. 30 at
14]. Thus, Dr. Kennedy found "nothing in the chart that even
minimally supports the prescription of Xanax." [Govt. Exh. 6 at
56]. Similar to the other files, Dr. Kennedy noted this patient file
failed to reflect any treatment modalities or a treatment plan.
[Id.]. Nor did this file contain any previous medical records for
E.V. [Govt. Exh. 30]. Lastly, Dr. Kennedy found that "this
patient's management [was] unacceptable and [fell] below a
reasonable standard of care." [Govt. Exh. 6 at 57].
I. Dr. Kennedy's Findings
In conclusion, Dr. Kennedy identified one patient out of the
nineteen patient files he examined where Respondent's treatment met
the standard of care. [Tr. 60; Govt. Exh. 6 at 23-24].
Dr. Kennedy found that the Respondent failed to maintain
appropriate patient records that supported his prescribing of
controlled substances. [Tr. 54-55; see G.A. Comp. R. & Regs. 360-
3-.02(7) (2012)]. To this point, Dr. Kennedy testified that a
patient's medical records are needed prior to treatment because the
doctor issuing the prescription "needs to know what medications,
what treatment modalities have been used in the past, either
successfully or unsuccessfully, to guide [the treating physician's]
treatment in the future." [Tr. 141]. Dr. Kennedy also concluded,
after his review of the patient files, that Dr. Enmon failed to use
"such means as history, physical examination, laboratory, or
radiographic studies, when applicable, to diagnose a medical
problem" because in many of the nineteen patient files there was a
"lack of appropriate physical examination or substantial supporting
documentation that would support large doses of narcotic
medication." [Tr. 55; Govt. Exh. 32 at 3; see G.A. Comp. R. & Regs.
360-3-.02(14) (2012)].
Similarly, Dr. Kennedy concluded that Respondent also failed to
document that he had taken precautions regarding "adverse
reactions, habituation, and the establishment of chemical
dependency" in the patients for whom he prescribed large quantities
of controlled substances. [Tr. 56; Govt. Exh. 32 at 3; see G.A.
Comp. R. & Regs. 360-3-.02(15) (2012)]. Lastly, Dr. Kennedy found
that the Respondent failed "to maintain patient records documenting
the course of the patient's medical evaluation, treatment, and
response," because there were numerous patient files containing
charts "with entirely blank physical examinations combined with
entirely blank follow-up visits." [Tr. 56; Govt. Exh. 32 at 3; see
G.A. Comp. R. & Regs. 360-3-.02(16) (2012)]. To this point, Dr.
Kennedy credibly testified that physicians are trained to document
every physical examination conducted on a patient. [Tr. 164]. If a
doctor fails to document a physical examination in the patient's
file, Dr. Kennedy explained that there is a "presumption [that]
[the] physical examination did not occur." [Id.].
Consequently, Dr. Kennedy found that the Respondent did not
issue prescriptions for controlled substances to these patients for
a legitimate medical purpose in the usual course of professional
practice. [Tr. 60; see 21 C.F.R. 1306.04(a) (2011)]. Instead, Dr.
Kennedy concluded that Respondent's prescribing created "a great
degree of concern about diversion, abuse, [and] overdosage." [Tr.
61]. In judging the legitimacy of Respondent's prescriptions, Dr.
Kennedy explained that a prescription would have to be valid based
upon the history, studies and physical examination of the patient by
the treating physician. [Tr. 160]. In addition, Dr. Kennedy credibly
explained that MRI reports, alone, do not provide the medical
justification for issuing controlled substances, because "sometimes
MRI's have equivocal findings, or findings that don't rise to the
level of prescribing controlled medication on their own, and they
have to be combined with a physical examination before a patient is
started down this road." [Tr. 140]. Dr. Kennedy also credibly
testified that pain patients warrant a higher level of scrutiny
because they "are taking chronic addictive medications that are
used recreationally." [Tr. 164]. But he noted that there were "a
fairly large number of cases" where Dr. Enmon's patients, on their
initial visit, "would be issued prescriptions for in excess of 300-
unit doses of narcotic medications" even though their "charts had
radiographic studies but no medical histories." [Tr. 60-61].
Specifically with regard to the Xanax prescriptions, Dr. Kennedy
found that Respondent prescribed a varying number of dosage units of
two milligram Xanax to all but one of the nineteen patients. [Govt.
Exh. 5; Tr. 137-138]. Two milligrams is one of the highest strengths
for that medication. [Tr. 138]. Dr. Kennedy opined that he would not
prescribe the highest dosage unit of Xanax as a starting level for
that medication. [Id.]. In Dr. Kennedy's expert medical opinion,
combining Xanax and other controlled substances can also have an
additive effect upon a patient. [Tr. 141-42]. Dr. Kennedy explained
that such combined effects are "a matter of concern and need to be
discussed with the patient." [Tr. 142].
Dr. Kennedy also noted that the Respondent routinely prescribed
thirty-milligram dosage units of Roxicodone along
[[Page 57123]]
with fifteen-milligram dosage units of Roxicodone to his patients.
[Govt. Exh. 5]. Dr. Kennedy explained that such prescribing is
appropriate for a patient who reports experiencing breakthrough pain
or "pain not responding to the initial dosage." [Tr. 139-140]. Yet
in his review of the Respondent's medical files, Dr. Kennedy found
no indication that there was any documented need for such
breakthrough pain medication. [Tr. 140].
IV. STATEMENT OF LAW AND DISCUSSION
A. Position of the Parties
1. Government's Position
The Government asserts that the appropriate remedy in this
matter is revocation of the Respondent's registration. [Govt. Brief
at 38]. Specifically in addressing the Section 823(f) public
interest factors, the Government argues that three of five factors
support the revocation of Respondent's registration. [Govt. Brief at
30]. First, the Government cites factors two and four and argues
that the Respondent's experience in dispensing controlled substances
and his noncompliance with the applicable law relating to controlled
substances weighs in favor of revocation. [Govt. Brief at 30-31].
Lastly, the Government cites factor five and argues that
Respondent's lack of remorse and his inability to claim any
persuasive mitigating factors for his conduct also supports the
revocation of his registration. [Govt. Brief at 31].
The Government makes several arguments under factors two and
four. First, citing the Xanax prescriptions, which Respondent issued
to eighteen of the nineteen patients in the record, the Government
argues that Respondent issued these prescriptions without a
legitimate medical purpose and outside the usual scope of
professional practice in violation of 21 C.F.R. 1306.04(a) (2011).
[Govt. Brief at 31]. Specifically the Government noted that nine
patient files revealed no complaints of anxiety symptoms yet all
nine of these patients received Xanax prescriptions from Respondent.
[Id.]. While the other nine patients reported anxiety symptoms, the
Government noted that their complaints only consisted of checking or
circling an entry on a boilerplate form, which the Government argued
was insufficient to justify prescribing the strongest possible
dosage of Xanax. [Govt. Brief at 32]. To this point, the Government
highlighted Dr. Kennedy's expert testimony that these Xanax
prescriptions were not medically justified. [Id.].
Next, the Government argues that Respondent's issuance of
oxycodone and hydrocodone prescriptions to all nineteen patients
also violated 21 C.F.R. 1306.04(a) (2011) and correspondingly
various Georgia administrative regulations. [Govt. Brief at 30, 32-
34]. First, the Government claims that none of the nineteen patient
files contained any past medical records in violation of Georgia
administrative regulations. [Govt. Brief at 31, 33]. Next, the
Government asserts that Respondent failed to adequately document
physical examinations for these patients, another violation of
Georgia administrative regulations. [Id.].
Similarly, the Government contends that neither the physical
examinations of the patients nor their MRI reports provided
sufficient justification for Respondent's treatment of these
patients with large dosages of heavy strength narcotics. [Id.]. In
addition, the Government argues that Dr. Enmon inappropriately
issued multiple prescriptions for controlled substances to treat
breakthrough pain, despite the patient files containing no
indication that the patients needed such treatment. [Govt. Brief at
34]. Furthermore, the Government claims, and Dr. Kennedy agrees,
that Respondent issued prescriptions for high strength controlled
substances without attempting any other treatment modalities. [Id.].
Lastly, the Government argues that Respondent violated federal
law by issuing controlled substances prescriptions from two
unregistered locations, namely the Brunswick Wellness Center and the
Ocean Care Clinic. [Id.]. The Government notes that Respondent
issued controlled substances prescriptions from Ocean Care even
though the DEA had not approved his change of address request for
this location. [Id.]. Moreover, the Government asserts that
Respondent wrote prescriptions for controlled substances during his
employment at BWC, but never submitted an address change request to
the DEA for this location. [Id.].
Lastly, under factor five, the Government argues that Respondent
has not accepted responsibility or shown any remorse for his alleged
unlawful conduct. [Govt. Brief at 31]. Nor, the Government contends,
has Respondent presented any persuasive mitigating evidence that
supports his continued registration. [Govt. Brief at 35-37]. In
conclusion, the Government argues that Dr. Enmon's continued
registration with the DEA would be inconsistent with the public
interest and that his registration should be revoked. [Govt. Brief
at 38].
2. Respondent's Position
Respondent did not file a post-hearing brief.
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 824(a)(4) (2006),\5\ the Administrator may
revoke a DEA Certificate of Registration if she determines that such
registration would be inconsistent with the public interest as
determined pursuant to 21 U.S.C 823(f). In determining the public
interest, the following factors are considered:
---------------------------------------------------------------------------
\5\ The Administrator has the authority to make such a
determination pursuant to 28 C.F.R. 0.100(b) (2011).
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f) (2006).
These factors are to be considered in the disjunctive; the
Administrator may rely on any one or a combination of factors and
may give each factor the weight she deems appropriate in determining
whether a registration should be revoked. See Robert A. Leslie,
M.D., 68 Fed. Reg. 15,227, 15,230 (DEA 2003). Moreover, the
Administrator is "not required to make findings as to all of the
factors." Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also
Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
The Government bears the burden of proving that the requirements
for revocation are satisfied. 21 C.F.R. 1301.44(e) (2011). Once the
Government has met its burden of proof, the burden of proof shifts
to the Respondent to show why his continued registration would be
consistent with the public's interest. See Medicine Shoppe--
Jonesborough, 73 Fed. Reg. 364, 380 (DEA 2008). To this point, the
Agency has repeatedly held that the "registrant must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct." Medicine Shoppe--Jonesborough, 73
Fed. Reg. at 387; see also Samuel S. Jackson, D.D.S., 72 Fed. Reg.
23,848, 23,853 (DEA 2007). In short, after the Government makes its
prima facie case, the Respondent must prove by a preponderance of
the evidence that he can be entrusted with the authority that a
registration provides by demonstrating that he accepts
responsibility for his misconduct and that the misconduct will not
re-occur.
1. Factor One: Recommendation of Appropriate State Licensing
Board.
Although the recommendation of the applicable state medical
board is probative to this factor, the Agency possesses "a separate
oversight responsibility with respect to the handling of controlled
substances" and therefore must make an "independent determination
as to whether the granting of [a registration] would be in the
public interest." Mortimer B. Levin, D.O., 55 Fed. Reg. 8,209,
8,210 (DEA 1990); see also Jayam Krishna-Iyer, M.D., 74 Fed. Reg.
459, 461 (DEA 2009). The ultimate responsibility to determine
whether a registration is consistent with the public interest has
been delegated exclusively to the DEA, not to entities within state
government. Edmund Chein, M.D., 72 Fed. Reg. 6,580, 6,590 (DEA
2007), aff'd, Chein v. DEA, 533 F.3d 828 (DC Cir. 2008). So while
not dispositive, state board recommendations are relevant on the
issue of revoking or maintaining a DEA registration. See Gregory D.
Owens, D.D.S., 74 Fed. Reg. 36,751, 36,755 (DEA 2009); Martha
Hernandez, M.D., 62 Fed. Reg. 61,145, 61,147 (DEA 1997).
In this case, the Georgia Composite Medical Board ("Georgia
Medical Board" or "the Board") has not taken any action against
Respondent's medical license or made any recommendations related to
this case. Nor has the Board made any recommendation concerning Dr.
Enmon's licensure. Nevertheless, the Agency has consistently held
that a practitioner's possession of state authority, while a
prerequisite to maintenance of a registration, is not dispositive of
the public interest
[[Page 57124]]
determination. Mark De La Lama, P.A., 76 Fed. Reg. 20,011, 20,018
(DEA 2011). Therefore, I find that this factor does not weigh in
favor or against the revocation of Respondent's DEA certificate of
registration.
2. Factors Two and Four: Registrant's Experience With Controlled
Substances And Compliance With Applicable State, Federal, Or Local Laws
Relating To Controlled Substances
Agency regulations provide that a prescription is lawful only if
it is "issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice." 21 C.F.R. 1306.04(a) (2011). This regulation places the
"responsibility for the proper prescribing * * * of controlled
substances" on the "prescribing practitioner," in this case, Dr.
Enmon. Id. As the Supreme Court has explained, "the prescription
requirement * * * ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses." Gonzales v. Oregon, 546 U.S. 243, 274 (2006). Likewise,
Georgia law contains a similar requirement for controlled substances
prescriptions. Ga. Code Ann. 16-13-41(f)(2-3) (2012) (mandating that
practitioners must "act[] in the usual course of [] professional
practice" and only issue controlled substances prescriptions for a
"legitimate medical purpose"); see also Strong v. State, 272 SE.2d
281 (Ga. 1980).
Under the Controlled Substances Act ("CSA" or "the Act"), it
is fundamental that a practitioner establish and maintain a good
faith doctor-patient relationship in order to act "in the usual
course of * * * professional practice" and to issue a prescription
for a "legitimate medical purpose." Laurence T. McKinney, 73 Fed.
Reg. 43,260, 43,265 n. 22 (DEA 2008). The CSA, however, generally
looks to state law to determine whether a doctor and patient have
established a good faith doctor-patient relationship. Kamir Garces-
Mejias, M.D., 72 Fed. Reg. 54,931, 54,935 (DEA 2007).
The Georgia Medical Board has determined that in Georgia it
constitutes "unprofessional conduct" for a physician to "fail[]
to maintain appropriate patient records whenever Schedule II, III,
IV or V controlled substances are prescribed." G.A. Comp. R. &
Regs. 360-3-.02(7) (2012). Appropriate patient records are defined
as containing: "the patient's name and address; the date, drug
name, drug quantity, and patient's diagnosis necessitating the
Schedule II, III, IV, or V controlled substances prescription; and
records concerning the patient's history." G.A. Comp. R. & Regs.
360-3-.02(7)(a-c) (2012). It is also "unprofessional conduct" for
a Georgia physician to "fail[] to maintain patient records
documenting the course of the patient's medical evaluation,
treatment, and response." G.A. Comp. R. & Regs. 360-3-.02(16)
(2012). Records which must be maintained include "history and
physical, progress notes[hellip]and laboratory reports." G.A. Comp.
R. & Regs. 360-3-.02(16)(a) (2012).
Additionally under Georgia administrative rules,
"unprofessional conduct" further includes:
Failing to use such means as history, physical examination,
laboratory, or radiographic studies, when applicable, to diagnose a
medical problem; and
Failing to use medications and other modalities based on
generally accepted and approved indications, with proper precautions
to avoid adverse physical reactions, habituation, or addiction in
the treatment of patients.
G.A. COMP. R. & REGS. 360-3-.02(14-15) (2012).
a. Recordkeeping Violations
In this case, Respondent concedes that the nineteen patient
files from his Ocean Care Clinic fail to record when physical
examinations were conducted and the specific results of those
examinations in support of his diagnoses. While Respondent testified
that he performed a physical examination on all Ocean Care patients,
he also testified that the charts introduced at the hearing revealed
that "an [physical] exam [was] not documented." [Tr. 343; Govt.
Exh. 12-30]. By not documenting a patient's physical examination in
his charts, Respondent violated Georgia law which mandates that
physicians maintain patient records, which specifically include the
results of a history and physical examination. G.A. Comp. R. & Regs.
360-3-.02(16) (2012). Despite Respondent's self-serving testimony
that the busy nature of his practice somehow excused him from
complying with this regulation, I find that Respondent, by failing
to document physical examinations, violated Georgia law. [Tr. 345].
Furthermore, Respondent does not dispute that the nineteen
patient files from his Ocean Care Clinic were incomplete and lacking
in the required patient history records in violation of Georgia
regulations. [Govt. Exh. 12-30; Tr. 357-358 ]. Instead Respondent
testified that many of his patients came from clinics that had been
shut down and that Ocean Care could not obtain their records. [Tr.
357]. But Respondent admitted that he did not document any efforts
to obtain these past medical records. [Tr. 358]. An examination of
the nineteen patient files reveals that while Dr. Enmon wrote
controlled substances prescriptions to all nineteen patients, their
Ocean Care patient file lacked any of their past medical records, or
even documentation of efforts to obtain these records. [Govt. Exh.
12-30]. Therefore, I find that Respondent violated Georgia law by
issuing controlled substance prescriptions to these nineteen
patients without obtaining their past medical records. G.A. Comp. R.
& Regs. 360-3-.02(7) (2012).
Related to these findings, I note that Dr. Kennedy concluded,
after his review of the patient files, that Dr. Enmon failed to use
"such means as history, physical examination, laboratory, or
radiographic studies, when applicable, to diagnose a medical
problem" because in almost all of the nineteen patient files there
was a "lack of appropriate physical examination or substantial
supporting documentation that would support large doses of narcotic
medication." [Tr. 55; Govt. Exh. 6]. Therefore, in light of the
Respondent's failure to document physical examinations or obtain any
patient records beyond an MRI report, I find that Respondent
violated Georgia law by failing to utilize these means to properly
diagnose his patients. G.A. Comp. R. & Regs. 360-3-.02(14) (2012).
b. Respondent's Prescribing Practices
Respondent issued Xanax prescriptions to all but one of the
patients whose files were introduced into the record. [Govt. Exh. 5;
Govt. Exh. 12-30]. Xanax is clinically indicated for the treatment
of anxiety and panic disorders. [Tr. 45-46; Govt. Exh. 11]. But nine
of these patient files revealed no self-reports or complaints of
anxiety or panic attack symptoyms. [Govt. Exh. 13, 15-18, 23-24, 27,
30]. Dr. Kennedy, an expert in the use of such medication, concluded
that these Xanax prescriptions lacked any legitimate medical
purpose. [Tr. 59, 60; Govt. Exh. 6 at 5, 11, 14, 17, 20, 35, 38, 47,
56]. In light of Dr. Kennedy's uncontroverted expert testimony that
these Xanax prescriptions were issued outside the usual scope of
professional practice and without a legitimate medical purpose, I
consequently find that that Respondent's issuance of these nine
prescriptions violated the prescription requirement of both federal
and state law. 21 C.F.R. 1306.04(a) (2011); Ga. Code Ann. 16-13-
41(f) (2012).
Respondent also issued Xanax prescriptions to the other nine
patients, however, these patients did report experiencing anxiety
and panic attack symptoyms. [Govt. Exh. 12, 14, 19-22, 25-26, 28].
But Dr. Kennedy credibly testified that prior to treating a patient
with Xanax, the patient's file should contain "substantial
documentation" that would support the assignment of a psychiatric
diagnosis to the patient. [Tr. 123, 171]. As the Government rightly
notes though, these patient files failed to contain any information
justifying these prescriptions except for a boilerplate form filled
out by the patient. [Govt. Brief at 32; Govt. Exh. 12, 14, 19-22,
25-26, 28]. Dr. Kennedy also questioned Respondent's initial choice
of Xanax as a frontline anxiety treatment and the corresponding high
dosage unit of Xanax which he prescribed to these patients. [Tr.
171-172]. He credibly concluded that these Xanax prescriptions could
not be medically justified. [Tr. 60; Govt. Exh. 6 at 2, 8, 23, 26,
29, 32, 41, 44, 50]. Respondent did not challenge Dr. Kennedy's
expert medical conclusion regarding these prescriptions.
Accordingly, I find that Respondent issued these Xanax prescriptions
for other than a legitimate medical purpose in violation of both
federal and state law. 21 C.F.R. 1306.04(a) (2011); Ga. Code Ann.
16-13-41(f) (2012).
Respondent further prescribed oxycodone or hydrocodone to all of
the nineteen patients whose files were introduced into the record.
[Govt. Exh. 5; Govt. Exh. 12-30]. While Dr. Kennedy testified that
chronic pain patients warrant a higher level of scrutiny because
they "are taking chronic addictive medications that are used
recreationally," he noted that there were "a fairly large number
of cases" where Dr. Enmon's patients, on their initial visit,
"would be issued
[[Page 57125]]
prescriptions for in excess of 300-unit doses of narcotic
medications." [Tr. 60-61, 164]. Even though Respondent's patients
typically reported experiencing high levels of pain, Dr. Kennedy
concluded that their MRI reports and physical examination findings
did not support Respondent's prescription of narcotic pain
medications. [Tr. 60, 140-141; Govt. Exh. 12-30; Govt. Exh. 6].
Specifically he testified that "the numbers and strengths of the
narcotic medications that were prescribed were not valid for
legitimate medical practice." [Tr. 160].
Thus, Dr. Kennedy, who was qualified as expert in the use of
controlled substances for pain management, concluded that there was
only one patient out of the nineteen where Respondent's issuance of
oxycodone or hydrocodone prescriptions met the standard of care.
[Tr. 59-60, 141; Govt. Exh. 6]. Dr. Enmon failed to introduce any
evidence or make any argument that his treatment of these patients
with narcotic pain medication was consistent with the Georgia
standard of care or the federal and state prescription requirement.
Nor did he challenge Dr. Kennedy's expert medical opinion regarding
his treatment of these patients with large numbers of high dosage
units of oxycodone and Xanax. Therefore I find that Respondent
issued prescriptions for oxycodone and Xanax to these patients in
violation of the prescription requirement of both federal and state
law. 21 C.F.R. 1306.04(a) (2011); Ga. Code Ann. 16-13-41(f) (2012)
Dr. Kennedy also highlighted two patients' files where
Respondent issued prescriptions for oxycodone, Xanax, and Soma.
[Govt. Exh. 6 at 2-3, 9]. In Dr. Kennedy's expert opinion, "the
unsupported coadministration of oxycodone, Xanax, and Soma" to
these patients "could represent a significant risk." [Id.].
Specifically he testified that "benzodiazepines and the opiates do
have an addictive effect" and that "the combined effects of these
medications is a matter of concern and needs to be discussed with
the patient." [Tr. 141-142]. Despite the potentially dangerous
addictive effect of combining these scheduled medications, Dr.
Kennedy did not find any evidence in the patient files that Dr.
Enmon took "any precautions[hellip]about adverse reactions,
habituation, [or] the establishment of chemical dependency" for
these patients. [Tr. 56; Govt. Exh. 12, 14]. Nor did Dr. Enmon
provide any relevant testimony or proffer any evidence to rebut Dr.
Kennedy's expert medical conclusion on this point. Therefore I find
that Respondent violated Georgia law by issuing controlled substance
prescriptions to these two patients without "proper precautions to
avoid..habituation or addiction in the treatment of patients." G.A.
Comp. R. & Regs. 360-3-.02(15) (2012).
Lastly, while the Government introduced evidence concerning
another of Respondent's patients, M.B.S., I find that the Government
has failed to prove, by a preponderance of the evidence, that
Respondent's treatment of M.B.S. violated the Georgia standard of
care. The Government did not introduce any expert medical testimony
concerning Respondent's treatment of this patient. C.f. Jack A.
Danton, D.O., 76 Fed. Reg. 60,900, 60,901 (DEA 2011). The only
evidence in the record pertaining to this patient is DI Sikes'
testimony regarding the complaint he received from a physician at a
local hospital and the patient's medical records which the hospital
faxed to the DEA. [Tr. 371-381; Govt. Exh. 7]. Despite the serious
allegations regarding Respondent's treatment of M.B.S. contained in
Government Exhibit 7, I note the hearsay nature of this complaint
and consequently decline to give it substantial weight in this
matter. Furthermore, I find that Respondent properly documented his
physical examination of M.B.S., in sharp contrast to the other
patient records introduced in this proceeding. [Govt. Exh. 7 at 5-
6]. Thus, I conclude that the Government has failed to prove that
Dr. Enmon's treatment of M.B.S. violated the applicable Georiga
standard of care.
c. Prescribing From An Unregistered Location
The CSA and DEA regulations also require registrants to obtain
separate registrations for each principal place of business or
professional practice where controlled substances are manufactured,
distributed, or dispensed. 21 U.S.C. 822(e) (2006); 21 C.F.R.
1301.12(a) (2011). The Agency, however, has provided a limited
exemption for practioners from this requirement. 21 C.F.R.
1301.12(b)(3) (2011). Specifically, a practitioner who is already
registered at a location in one state is not required to obtain a
separate registration for another office located in that same state
if the practioner only prescribes controlled substances from that
second office and also does not maintain any supplies of controlled
substances at that second office. Id. Agency regulations, however,
also specify that a registrant's certificate of registration "shall
terminate" if the registrant "discontinues business or
professional practice" 21 C.F.R. 1301.52(a) (2011).
In addition, any registrant may apply to modify his registration
in order to, among other things, change his address, by submitting a
request to the Agency. 21 C.F.R. 1301.51 (2011). The regulation
further provides that "the request for modification shall be
handled in the same manner as an application for registration."
Id.; see also Wedgewood Vill. Pharm., Inc. v. Ashcroft, 293 F. Supp.
2d 462, 469 (D.N.J. 2003) ("There is no provision at any other
place in either the CSA itself, or in DEA's regulations, that
indicates or even suggests that the approval of a modification to a
registration by the DEA is anything other than permissive.").
Therefore, while the address change request is pending with the DEA,
the registrant is not authorized to handle controlled substances at
the new location until the DEA approves the modification. See 21
C.F.R. 1301.13(a) (2011) ("No person required to be registered
shall engage in any activity for which registration is required
until the application for registration is granted and a Certificate
of Registration is issued by the Administrator to such person.");
Richard A. Herbert, M.D., 76 Fed. Reg. 53,942, 53,959 (DEA 2011).
Here the Government argues that Respondent violated federal law
by issuing prescriptions for controlled substances from two
unregistered locations, the Brunswick Wellness Center and the Ocean
Care Clinic. [Govt. Brief at 31, 34]. The Government does note that
Dr. Enmon ceased issuing prescriptions from Ocean Care after he
received notification from the DEA that he was not allowed to handle
controlled substances at that location. [Govt. Brief at 34].
I find, by a preponderance of the evidence, that Respondent
issued controlled substances prescriptions while working at BWC from
approximately May 2011 to July 2011. [Tr. 180, 184, 333-335, 363-
365; Govt. Exh. 33]. I also find that Dr. Enmon did not seek or
obtain a certificate of registration from the DEA which would have
authorized him to practice at this location. [Govt. Exh. 3; Tr. 180-
181]. In addition, I find that Respondent's registered address in
Atlanta does not trigger the exemption in 21 C.F.R. 1301.12(b)(3)
(2011), because Dr. Enmon had ceased practicing at his original
registered address in approximately 2009. [Tr. 177, 204-205; see
also 21 C.F.R. 1301.52(a) (2011)]. Thus because Dr. Enmon was
neither authorized by the DEA to prescribe at BWC, nor entitled to
the relevant exemption for practitioners, I find that he violated
federal law by issuing controlled substance prescriptions from BWC. 21 U.S.C. 822(e) (2006); 21 C.F.R. 1301.12(a) (2011).
Similarly, I find, by a preponderance of the evidence, that
Respondent issued prescriptions for controlled substances while he
operated the Ocean Care Clinic from approximately August 2011 to
December 2011. [Tr. 188, 192-193; Govt. Exh. 12-30]. While
Respondent requested to change his DEA registered address to Ocean
Care on August 31, 2011, I find that the DEA did not approve Dr.
Enmon's address change request. [Govt. Exh. 3; Tr. 175-176]. While
Dr. Enmon's address change request was pending with the DEA, he
lacked the necessary authority to issue prescriptions for controlled
substances from Ocean Care. 21 C.F.R. 1301.13(a) (2011); Herbert, 76
Fed. Reg. at 53,959 ("Unlike a renewal application, which, when
timely filed, remains in effect past the registration expiration
date while the DEA makes a final determination on the application, a
request for a modification is treated as a new application; a
registrant, therefore, is not authorized to dispense or prescribe
controlled substances at his new location pending approval of a
modification request to change a DEA registered address.").
Consequently, I find that Respondent violated federal law by issuing
controlled substance prescriptions from Ocean Care without a DEA
registration. 21 U.S.C. 822(e) (2006); 21 C.F.R. 1301.12(a) (2011).
In summary, I find that Respondent violated Georgia law by
failing to adequately document physical examinations in his patient
files and by prescribing controlled substances to patients without
attempting to obtain their past medical records. Next, I find that
Respondent was at the very least, reckless or grossly negligent in
issuing narcotic and benzodiazepine prescriptions for other than a
legitimate medical purpose in violation of both federal and state
law. Lastly, I find that Respondent violated federal law by issuing
prescriptions for controlled substances from two unregistered
[[Page 57126]]
locations. The scope and severity of Dr. Enmon's illicit conduct
weighs strongly in favor of a finding that Respondent's continued
registration would be inconsistent with the public interest.
Accordingly under factors two and four, I find that the grounds do
exist for revoking the Respondent's DEA Certificate of Registration.
3. Factor Three: Applicant's Conviction Record Relating to Controlled
Substances
The record contains no evidence that the Respondent has been
convicted of an offense related to the manufacture, distribution or
dispensing of controlled substances. While this factor may support
the continuation of Respondent's registration, the Agency has held
that this factor is not dispositive to the public interest
determination. Morris W. Cochran, M.D., 77 Fed. Reg. 17,505, 17,517
(DEA 2012).
4. Factor Five: Other Factors Affecting the Public Interest
After the Government "has proved that a registrant has
committed acts inconsistent with the public interest, a registrant
must 'present sufficient mitigating evidence to assure the
Administrator that [he] can be entrusted with the responsibility
carried by such a registration.' " Medicine Shoppe--Jonesborough,
73 Fed. Reg. 364, 387 (DEA 2008) (quoting Samuel S. Jackson, D.D.S.,
72 Fed. Reg. 23,848, 23,853 (DEA 2007). "Moreover, because 'past
performance is the best predictor of future performance,' Alra
Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has
repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct." Medicine Shoppe--Jonesborough, 73
Fed. Reg. at 387; see also Samuel S. Jackson, D.D.S., 72 Fed. Reg.
23, 848, 23,853 (DEA 2007); John H. Kennedy, M.D., 71 Fed. Reg.
35,705, 35,709 (DEA 2006); Prince George Daniels, D.D.S., 60 Fed.
Reg. 62,884, 62,887 (DEA 1995). See also Hoxie v. DEA, 419 F.3d 477,
483 (6th Cir. 2005) ("admitting fault" is "properly
consider[ed]" by DEA to be an "important factor[]" in the public
interest determination).
Here, I find that Respondent has neither admitted responsibility
for his actions nor shown any remorse for his unlawful conduct.
Respondent testified at the hearing and denied violating any federal
or state law while practicing at Ocean Care. [Tr. 341]. Instead,
Respondent testified that he was the victim of a conspiracy which
involved both local and federal law enforcement, whose objective,
according to Dr. Enmon, was closing Respondent's pain clinic in
order to benefit a competing pain clinic. [Tr. 342-43]. In light of
the ample evidence in the record showing Respondent's numerous
violations of both federal and state law, I do not find Dr. Enmon's
allegations of a conspiracy to be credible.
In addition, Respondent has failed to demonstrate any remedial
measures he has undertaken to prevent the reoccurrence of his
unlawful conduct. Respondent chose not to address any of the
nineteen patient files which the Government had introduced into
evidence or challenge Dr. Kennedy's expert medical opinion that
Respondent's treatment for eighteen of the nineteen patients
violated the Georgia standard of care. Nor did Dr. Enmon offer any
persuasive assurance that he would modify his treatment of chronic
pain patients. Dr. Enmon testified that the only change he would
make to his practice would be to better document efforts to obtain
patients' past medical records. [Tr. 358]. Therefore, there is no
evidence in the record that Dr. Enmon will alter his practice of
medicine in order to bring himself into compliance with federal and
state law. C.f. Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 459 (DEA
2009) (highlighting remedial measures undertaken by a physician
including conducting criminal background checks on patients and
developing new procedures to recognize and discharge likely drug
abusers).
The only specific allegation Respondent attempted to rebut
involved the documentation of the physical examinations he claimed
to conduct on his patients. But Dr. Enmon's rebuttal only further
demonstrates the danger his continued registration poses to the
public interest. While Respondent acknowledged his patient files
contained charts where "a [physical] examination [was] not
documented," he claimed that while he tried to "do [his] best to
document * * * sometimes days get busy." [Tr. 345]. As Dr. Kennedy
testified, however, "[e]very physician knows from being taught in
medical school that if [a physical examination] is not documented it
did not happen." [Tr. 164]. Respondent's cavalier approach to a
fundamental requirement of medical practice, the documentation of
treatment, poses a continuing danger to the public interest. [Tr.
165].
Respondent also failed to introduce any persuasive mitigating
evidence under factor five. Respondent's contention that narcotic
therapy was the only cost-effective treatment for his low-income
patient base, a claim that other practitioners have advanced, has
been squarely rejected by the Agency. Bienvenido Tan, M.D., 76 Fed.
Reg. 17,673, 17,680 (DEA 2011) (noting that despite the physician's
claim regarding his patient base, "given that some of these
patients had the ability to purchase more drugs (and sometimes
multiple drugs) on numerous occasions within a month, it seems
likely that they had the ability to pay for some tests and/or
consultations"). Indeed as the Government rightly points out,
Respondent's own patient files do not reflect any discussions of any
alternative treatments, regardless of their cost, besides the
seemingly automatic prescription of scheduled medications. [Govt.
Brief at 35; Govt. Exh. 12-30]. Similarly, Respondent's complaint
that his entire practice could not properly be judged only on the
nineteen patient files introduced into evidence also has been
rejected by the Agency. [Tr. 345; see Jacobo Dreszer, M.D., 76 Fed.
Reg. 19,386, 19,387 (DEA 2011) ("Moreover, where the Government has
seized files, it can review them and choose to present at the
hearing only those files which evidence a practitioner's most
egregious acts.")]. In fact, the Agency has revoked "other
practitioners' registrations for committing as few as two acts of
diversion." Krishna-Iyer, 74 Fed. Reg. at 463 (citing Alan H.
Olefsky, 57 Fed. Reg. 928, 928-29 (DEA 1992)).
Therefore, I find that Respondent has failed to present any
evidence demonstrating his acceptance of responsibility for his
unlawful acts. Likewise, I find that Respondent has failed to
proffer any evidence demonstrating remedial measures that he has
undertaken to prevent the reoccurrence of his violations. Lastly, I
find that Respondent has not presented any persuasive mitigating
factors under factor five that would justify his continued
registration.
V. CONCLUSION AND RECOMMENDATION
Therefore, I conclude that the DEA has met its burden of proof
and has established that grounds exist for revoking the Respondent's
DEA registration. The record contains ample evidence that Respondent
violated federal and state law in his practice at both BWC and Ocean
Care. These violations range from issuing medically illegitimate
prescriptions and failing to properly document patient treatment to
prescribing from an unregistered location. In light of Respondent's
numerous serious violations of both federal and state law and his
corresponding refusal to accept responsibility for his unlawful
conduct or adopt remedial measures to prevent their reoccurence, I
find that Respondent's continued registration with the DEA would be
inconsistent with the public interest. Consequently, I recommend
that Respondent's controlled substances registration be revoked and
his application for renewal and modification of his DEA registration
be denied.
Date: April 26, 2012
s/Gail A. Randall
Administrative Law Judge.
[FR Doc. 2012-22848 Filed 9-14-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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