Cleveland J. Enmon, Jr., M.D.; Decision and Order, 57116-57126 [2012-22848]

Download as PDF 57116 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 5. Outstanding action jackets: None. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. By order of the Commission. Issued: September 12, 2012. William R. Bishop, Hearings and Meetings Coordinator. [FR Doc. 2012–22958 Filed 9–13–12; 4:15 pm] BILLING CODE 7020–02–P Dated: August 31, 2012. Michele M. Leonhart, Administrator. Brian Bayly, Esq., for the Government Cleveland J. Enmon, Jr., M.D., for the Respondent DEPARTMENT OF JUSTICE Drug Enforcement Administration RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE Gail A. Randall, Administrative Law Judge. [Docket No. 12–31] Cleveland J. Enmon, Jr., M.D.; Decision and Order mstockstill on DSK4VPTVN1PROD with NOTICES 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. 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)). VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 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]. 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. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17SEN1.SGM 17SEN1 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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]. mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 57117 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 crossexamination 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 twentyfive 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 E:\FR\FM\17SEN1.SGM 17SEN1 57118 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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]. 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 nonnarcotic 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 1 The Respondent never filed an application to change his DEA registration from Atlanta to the Brunswick Wellness Center. [Tr. 180–181]. 2 The patient files and testimony about those files are protected by a Protective Order in this proceeding. [ALJ Exh. 6]. 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.]. mstockstill on DSK4VPTVN1PROD with NOTICES 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]. VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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. E:\FR\FM\17SEN1.SGM 17SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices [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]. 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, nonscheduled 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]. 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 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]. 4 Lorcet is the brand name for combination hydrocodone and Tylenol, a schedule III controlled substance. [Tr. 76]. VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 57119 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. E:\FR\FM\17SEN1.SGM 17SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 57120 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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 multilevel 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 VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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]. E:\FR\FM\17SEN1.SGM 17SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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 VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 57121 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…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]. E:\FR\FM\17SEN1.SGM 17SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 57122 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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 VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 thirtymilligram dosage units of Roxicodone along E:\FR\FM\17SEN1.SGM 17SEN1 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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]. mstockstill on DSK4VPTVN1PROD with NOTICES 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.]. VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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: (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. 5 The Administrator has the authority to make such a determination pursuant to 28 C.F.R. 0.100(b) (2011). PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 57123 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 E:\FR\FM\17SEN1.SGM 17SEN1 57124 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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. mstockstill on DSK4VPTVN1PROD with NOTICES 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…and laboratory reports.’’ G.A. Comp. R. & Regs. 360–3.02(16)(a) (2012). VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17SEN1.SGM 17SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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…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 VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 57125 [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 E:\FR\FM\17SEN1.SGM 17SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 57126 Federal Register / Vol. 77, No. 180 / Monday, September 17, 2012 / Notices 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 VerDate Mar<15>2010 19:43 Sep 14, 2012 Jkt 226001 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF JUSTICE Drug Enforcement Administration Henri Wetselaar, M.D.; Decision and Order On September 27, 2011, I, the Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Henri Wetselaar, M.D. (Respondent), of Las Vegas, Nevada. The Show Cause Order proposed the revocation of Respondent’s DEA Certificate of Registration as a practitioner, and the denial of any application to renew or modify his registration, on the ground that Respondent’s ‘‘continued registration is inconsistent with the public interest.’’ Show Cause Order at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)). The Show Cause Order alleged that from April through August 2010, law E:\FR\FM\17SEN1.SGM 17SEN1

Agencies

[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.
---------------------------------------------------------------------------

    \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)).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.

    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].
---------------------------------------------------------------------------

    \1\ The Respondent never filed an application to change his DEA 
registration from Atlanta to the Brunswick Wellness Center. [Tr. 
180-181].
---------------------------------------------------------------------------

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].
---------------------------------------------------------------------------

    \2\ The patient files and testimony about those files are 
protected by a Protective Order in this proceeding. [ALJ Exh. 6].
---------------------------------------------------------------------------

    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].
---------------------------------------------------------------------------

    \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].
---------------------------------------------------------------------------

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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.