Source: https://www.deadiversion.usdoj.gov/fed_regs/actions/2011/fr0407_3.htm
Timestamp: 2019-04-25 16:01:56+00:00

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Having reviewed the record in its entirety including the ALJ's recommended decision, I have decided to adopt the ALJ's rulings, findings of fact,\2\ conclusions of law,\3\ and recommended Order.
\2\ The ALJ found that there is "no evidence that the Respondent 'prescribe[d] and dispense[d] inordinate amounts of controlled substances." ALJ at 26. While there is no evidence as to the amounts that Respondent directly dispensed, there is evidence, which is unrefuted, that Respondent prescribed inordinate amounts of controlled substances. In his report, an Expert witness explained that the usual starting dose of Xanax is .25 to .5 mg. once to twice per day and yet Respondent prescribed Xanax 2 mg. twice per day to patients "who had not had Xanax before or recently," and that he did so without documenting that he had considered any of the possible underlying causes of his patients' complaint that they had anxiety; moreover, Respondent did not refer the patients to a mental health professional. GX 5, at 9-10. As the Expert explained, "[t]he treatment was with a very high dose of the controlled substance Xanax. This was clearly not within the boundaries of professional practice." Id. at 10. There is also unrefuted evidence that Respondent's prescribing of drug cocktails of oxycodone and Xanax lacked a legitimate medical purpose. Id. at 13. In this manner, Respondent did prescribe inordinate amounts.
\3\ I do not, however, adopt the ALJ's discussion of the standards applied by the Agency in assessing a practitioner's experience in dispensing controlled substances, which cites cases involving list chemical I distributors, a different category of registrant. See ALJ at 25-26. As the Agency has previously made clear, DEA can revoke based on a single act of intentional diversion and "evidence that a practitioner has treated thousands of patients" in circumstances that do not constitute diversion "does not negate a prima facie showing that the practitioner has committed acts inconsistent with the public interest." Jayam Krishna-Iyer, 74 FR 459, 463 (2009). See also Dewey C. MacKay, 75 FR 49956, 49977 (2010); Medicine Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (noting that pharmacy "had 17,000 patients," but that "[n]o amount of legitimate dispensings can render * * * flagrant violations [acts which are] 'consistent with the public interest"'), aff'd, Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 2008). As I further explained, "[w]hile such evidence may be [entitled to] some weight in assessing whether a practitioner has credibly shown that [he] has reformed his practices," it is entitled to no weight where a practitioner fails to acknowledge his wrongdoing. Krishna-Iyer, 74 FR at 463.
In any event, Respondent offered no evidence on the issue of his experience in dispensing controlled substances and the ALJ's ultimate conclusions that Respondent violated the CSA's prescription requirement because he dispensed controlled substance prescriptions that were not "within 'the usual course of [his] professional practice,' " ALJ at 39 (quoting 21 CFR 1306.04(a)), and that "the evidence under the [experience] * * * factor support[s]" the revocation of his registration, is consistent with Agency precedent. Id. With respect to factor five, "[s]uch other conduct which may threaten public health and safety," 21 U.S.C. 823(f)(5), the ALJ opined that "an adverse finding under this factor requires some showing that the relevant conduct actually constituted a threat to public safety." ALJ at 39 (emphasis added). Contrary to the ALJ's reasoning, Congress, by inserting the word "may" in factor five, clearly manifested its intent to grant the Agency authority to consider conduct which creates a probable or possible threat (and not only an actual) threat to public health and safety. See Webster's Third New Int'l Dictionary 1396 (1976) (defining "may" in relevant part as to "be in some degree likely to"); see also The Random House Dictionary of the English Language 1189 (1987) (defining "may" in relevant part as "used to express possibility"). While the ALJ misstated the applicable standard, his conclusion that Respondent repeatedly ignored "red flags" indicative of likely diversion and thus "created a significant potential conduit for the unchecked diversion of controlled substances," ALJ at 39, is clearly supported by substantial evidence and warrants an adverse finding under factor five.
The ALJ also opined that "[i]t is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being 'issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,' resort must be had to an expert." ALJ at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the importance of expert testimony in this case, in which the Government primarily relied on a review of the medical charts, whether expert testimony is needed in any case necessarily depends on the nature of the allegations and the other evidence in the case. Where, for example, the Government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of Federal law.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration, BA6733578, issued to Michael J. Aruta, M.D., be, and it hereby is revoked. I further order that any pending application of Michael J. Aruta, M.D., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.
Larry P. Cote., Esq., for the Government.
Bernard M. Cassidy., Esq., for the Respondent.
John J. Mulrooney, II, Administrative Law Judge. On February 25, 2010, the Deputy Administrator, Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO), immediately suspending the DEA Certificate of Registration (COR), Number BA6733578, of Michael J. Aruta, M.D. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging that such registration constitutes an imminent danger to the public health and safety. The OSC/ISO also seeks revocation of the Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial of any pending applications for renewal or modification of such registration, pursuant to 21 U.S.C. 823(f), alleging that the Respondent's continued registration is inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f). On March 24, 2010, the Respondent timely requested a hearing, which was conducted in Miami, Florida, on July 7, 2010 through July 9, 2010.\4\ The immediate suspension of the Respondent's COR has remained in effect throughout these proceedings.
The issue ultimately to be adjudicated by the Deputy Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes by substantial evidence that Respondent's registration with the DEA should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4). The Respondent's DEA practitioner registration expires by its terms on June 30, 2012.
further charges that these prescriptions were issued outside the usual course of professional practice based on a variety of circumstances \6\ surrounding the manner in which American Pain has been operated and the manner in which its physicians, to include the Respondent, has engaged in the practice of medicine. Id. The OSC/ISO also sets forth the Government's allegation that Respondent's former patients have apprised law enforcement personnel that "they were able to obtain prescriptions for controlled substances from [the Respondent] for other than a legitimate medical purpose and with little or no medical examination." Id.
GS Langston testified that the investigation of the American Pain Clinic had its origins on November 30, 2009, during a routine inspection that she and a subordinate diversion investigator conducted at Appurtenance Biotechnology, LLC, a pharmacy doing business under the name Boca Drugs (Boca Drugs), and located a few blocks away from one of the former locations of American Pain. Tr. at 713, 717-20. According to Langston, an examination of the prescriptions seized from Boca Drugs revealed that the majority of those prescriptions were for oxycodone and alprazolam authorized over the signature of physicians associated with American Pain.\7\ Id. at 721. Under Langston's supervision, DEA diversion investigators catalogued the prescriptions seized at Boca Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. A review of the data relative to the Respondent on the Boca Drug Prescription Log reveals that from November 2, 2009 through November 25, 2009, 175 controlled substance prescriptions issued over the Respondent's signature, to eighty-nine patients, only five of whom resided in Florida. The remainder of the patients had listed addresses in Kentucky, Tennessee, Ohio, Georgia, Massachusetts, West Virginia, North Carolina, Virginia, and South Carolina.
\7\ Although GS Langston testified that DEA immediately suspended the COR that had been issued to Boca Drugs, Tr. at 715, and that a voluntary surrender by that registrant followed a day later, id. at 776, no evidence has been presented that would lend that fact any particular significance related to any issue that must or should be found regarding the disposition of the present case.
Please do NOT fill your prescriptions at any WALGREENS PHARMACY \8\ or OUTSIDE the STATE OF FLORIDA.
\8\ GS Langston testified that she was unaware of the location of the closest Walgreens to American Pain's offices. Tr. at 779. No evidence was presented that would tend to establish that any Walgreens or any other pharmacy has taken a position regarding its willingness to fill prescriptions authorized by American Pain.
Langston also testified that while she was present in the American Pain offices, she noticed that each physician's desk was equipped with a group of stamps, each of which depicted a controlled substance medication with a corresponding medication usage instruction (sig). Tr. at 738-39. A photograph of one set of prescription script stamps was admitted as an exhibit.\9\ Govt. Ex. 119 at 2.
\9\ Although GS Langston testified that she did not actually take the photographs taken during the search warrant execution at American Pain, she did provide sufficient, competent evidence to support the admission of the photographs that were ultimately received into evidence. Tr. at 737, 739-41.
Langston also explained DEA's Automated Record Consolidated Ordering System (ARCOS) \10\ and testified that she generated an ARCOS report relative to the Respondent's ordering of controlled substances from January 2009 through February 2010.\11\ Govt. Ex. 2.
\10\ GS Langston explained that through the ARCOS system, "[d]rug manufacturers and distributors are required to report the sale of certain controlled substances to DEA," and the system "shows the history of a drug from the point of manufacture through the distribution chain to the retail dispensing level." Tr. at 685- 86.
\11\ For reasons that were never made clear, the ARCOS report begins with a 2006 entry. Govt. Ex. 2 at 1.
In the same fashion, Langston explained the purposes of and circumstances behind the generation of State prescription monitoring reports (PMPs) relative to the Respondent maintained by West Virginia and Kentucky. Govt. Exs. 3, 4. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 210 controlled substance prescriptions issued over the Respondent's signature to fifty-five patients located in West Virginia, and 182 similar prescriptions provided to seventy-eight Kentucky-based patients were filled between January 1, 2009 and April 4, 2010. Id.
of the data set forth in any of these databases to any issue that must or should be considered in deciding the present case.
SA Michael Burt testified that he has been employed by DEA since March 2004 and has been stationed with the Miami Field Division (MFD) since September 2004. Tr. at 813-14. Burt testified that he is the lead case agent for DEA in the investigation of American Pain Clinic and has participated in the investigation since the latter part of 2008. According to Burt, American Pain, which was previously known by the name South Florida Pain, has conducted business at four different locations, and he surveilled the Boca Raton and Lake Worth locations both in person and by periodic live review of video captured via pole cameras \12\ set up outside the clinic. Id. at 815-17. These pole cameras, which were in operation during a three week period from January to February 2010, were initially in operation on a 24 hour basis, but Burt testified that they were later activated only between the hours of 7 a.m. through 6 p.m. due to an observed lack of activity at the clinic outside of that time period. Id. at 820-21. The pole camera recordings were not offered into evidence at the hearing or made available to opposing counsel.
Based on these surveillance efforts, SA Burt testified concerning various activities he observed occurring outside the Boca and Lake Worth clinic locations, which were open to the public from 8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given day, beginning at 7 a.m. in the morning, automobiles could be seen pulling into the parking lot and approximately twenty to thirty people were routinely lined up outside of the clinic waiting to gain admittance. Additionally, there was a steady stream of automobile and foot traffic in and out of the clinic throughout the day. Id. at 817, 821. Burt testified that in his estimation, approximately 80-90 percent of the automobiles had out-of-State tags, predominantly from Kentucky, Ohio, West Virginia and Tennessee. Id. at 817-18. Burt also observed security personnel with "staff" written on their shirts \13\ riding around the exterior of the building in golf carts and who, in Burt's assessment, appeared to be directing patients into the American Pain facility. Burt indicated his surveillance of the Lake Worth location yielded similar observations. Id. at 818.
\17\ Burt further testified that the doctors were paid $75.00 per patient visit, id. at 884, but because he indicated that he could not disclose his basis of knowledge for this information, this portion of his testimony can be afforded no weight. To proceed otherwise would deny the Respondent the ability guaranteed by the APA "to conduct such cross-examination as may be required for a full and true disclosure of the facts." 5 U.S.C. 556(d); see Richardson v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233 F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 928 F.2d 227, 230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir. 1980).
for controlled substances that the patients claimed to be legitimately taking, with a view towards falsely providing evidence to the American Pain doctors showing that they were actually taking prescribed medications and not diverting them. Id. at 828-29. During cross- examination, Burt explained that Dr. Sollie told him he had raised these concerns with Christopher George, the owner of American Pain, and that Burt had no evidence that the deficient practices that Sollie had objected to continued through 2010. Id. at 900, 906. Burt also acknowledged that he was aware Dr. Sollie had been involved in litigation with Mr. George and that their relationship was strained. Id. at 1009. Dr. Sollie was not called as a witness by either party.
\20\ On cross-examination, SA Burt stated that he did not know whether it was true that the Respondent began working at the clinic in 2009 (a representation made by Respondent's counsel, but not in evidence), which (at least according to the question posed) would have been after Sollie's employment at the clinic had already ended. Tr. at 898.
\21\ On cross-examination, SA Burt responded in the negative when asked if he had "anywhere" in his possession a copy of the prescription at issue and whether he had supplied Government counsel with a copy of this individual's patient file. Tr. at 894.
\22\ In light of the inability to identify the name of this source of information to opposing counsel, and the lack of detail and corroborating evidence related to the information derived from her, no weight can be assigned to SA Burt's testimony concerning information provided by CS2, beyond the fact that this interaction may have informed the course of DEA's investigation. To proceed otherwise would deny the Respondent the ability guaranteed by the APA "to conduct such cross-examination as may be required for a full and true disclosure of the facts." 5 U.S.C. Sec. 556(d); see Richardson v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233 F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 928 F.2d 227, 230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir. 1980).
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.\23\ Burt's record testimony indicates that DEA Task Force Officer \24\ (TFO) Barry Adams informed him that a Kentucky resident named TY overdosed in Kentucky from oxycodone intoxication induced by medication procured at American Pain. Burt testified that this information was furnished pursuant to a working law enforcement relationship between the Kentucky State Police, Kentucky FBI, Kentucky DEA and Miami DEA aimed at addressing "the brunt of the pill problem" centered within the State of Kentucky relative to illegal use and resale of prescription pain medications. Id. at 833-35. However, in his testimony, Burt was unable to recall the name of the doctor from whom TY obtained his pills, and, thus, no admissible evidence was presented by the Government with respect to TY's death.\25\ Likewise, the record evidence concerning SM did not implicate prescribing activity by the Respondent.
\23\ Although similar testimony concerning the overdose death of a third individual, OB, was noticed in the Government's prehearing statement, it was not offered by the Government at the hearing. ALJ Ex. 6 at 8.
\24\ According to SA Burt, a "task force officer" is a local police officer or sheriff's deputy that is assigned to work on a DEA task force, rather than a sworn DEA criminal investigator. Tr. at 1031.
\25\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and associated testimony).
Perhaps among the more striking aspects of SA Burt's performance on the witness stand is the anticipated testimony which he did not provide. When viewed in its entirety, SA Burt's record testimony was stunningly sparse when compared with his proposed testimony as noticed in the Government's prehearing statement.\26\ That certain information may be unavailable for reasons related to other litigation forums, or other equally valid reasons, are of no moment with respect to the evaluation that must be made at this administrative forum. Equally important, such considerations do not alter the burdens imposed upon the respective parties. Simply put, the admitted evidence must succeed or fail on its own merits, irrespective of extraneous considerations.
Even apart from the marked contrast between the Burt testimony as proffered and as realized, his testimony was marred by periodic memory failures on significant issues and an inability to supply details to an extent that it could arguably have diminished the weight that could be fairly attached to those aspects of his own investigation that he did manage to recollect. During his testimony, SA Burt acknowledged his own marked lack of preparation and unfamiliarity with the investigation and confessed simply that "[t]here's no excuse * * * " Id. at 1003-05.
unspecified number of patient files seized pursuant to a criminal search warrant executed at the Respondent's practice on March 3, 2010 (Patient Charts Analysis).
\29\ Dr. Kennedy testified that he asked that the charts be selected randomly and not be "cherry picked" or selected with a view towards influencing his conclusions. Tr. at 214. As discussed, above, GS Langston testified that the reviewed charts were not selected with a view toward influencing Dr. Kennedy's opinion. Tr. at 768.
In Dr. Kennedy's expert opinion, based on a documentary review of the patient charts from the Respondent's practice that he reviewed, the Respondent's prescribing practices fell below the standards set forth by the Florida Medical Board. Tr. at 118. Furthermore, Dr. Kennedy testified that after reviewing the charts, he was unable to identify any legitimate basis for prescribing any of the controlled substance medications prescribed to the patients named in the charts. Id.
During the course of his testimony, Dr. Kennedy explained that he took professional issue with several aspects of the Respondent's patient care as reflected in the charts regarding the prescribing of controlled substances. It is apparent from his testimony that Dr. Kennedy's analysis is restricted to those matters which can be gleaned from an examination of the written word in that subset of the Respondent's patient charts provided by the Government for his review, and that limitation perforce circumscribes the breadth of his testimony. That being said, Dr. Kennedy highlighted numerous features in the Respondent's chart documentation that he found wanting, or at least remarkable.
While acknowledging that some standardization and utilization of forms is not, standing alone, improper,\30\ Dr. Kennedy took issue with what he perceived as flaws in the forms utilized by the Respondent to document patient care. According to Dr. Kennedy, the forms inadequately distinguished between the history and physical examinations, and failed to sufficiently document an adequate pain assessment. Id. at 79-80, 128-31. According to Dr. Kennedy, the charts also did not document activities that improved or exacerbated pain symptoms, and did not document self-described patient limits, neurological signs and objective observations, such as gait and station. Id. at 81. Dr. Kennedy testified that the chart entries were so defective that the Respondent did not establish a sufficient doctor-patient relationship to justify the prescribing of controlled substances, and that "this was not the practice of medicine in [his] opinion. Id. at 160-61.
Dr. Kennedy explained that there are basic elements to practicing pain medicine. The acquisition of a thorough history and physical examination is important. Id. at 44. He also stressed the vital importance of obtaining past medical records to evaluate what treatments, therapies, medications, and dosages have been utilized in the past so that correct current treatment decisions can be made. Id. at 47-48. Reliance upon the patient's memory of these elements without the prior medical records, in Dr. Kennedy's view, is not reliable or acceptable. Id. at 49-51. Although the Respondent's charts routinely contained a form which purports to require patients to see their primary care physicians, Dr. Kennedy testified that none of the files contained any record of any communication with any primary care physician from any patient. Id. at 114-16.
Kennedy also explained the importance of establishing a differential or working diagnosis on the first visit and modifying and reviewing that diagnosis as more information and results become available. Id. at 52. Similarly, a diagnostic plan is a systematic methodology of eliminating possible causes of symptoms to allow the treating physician to accurately determine what is causing them so that a successful treatment plan can be developed. Id. at 52-53. In other words, the diagnostic plan allows the treating doctor to eliminate or confirm items on the differential diagnosis. Id. at 54.
[the] particular pain level, where the pain was located, what it felt like, when was it worse, what made it better, what it made it worse, what have you done to alleviate or past treatments, and what can you not do with the pain? Observations on physical examination about how the person walks, gait and station. Consistency of neurologic and inadequacy of pathologic reflexes particularly, presence or absence, and adequate sensory examination. Musculoskeletal examination. And height and weight many times were not present.
Id. at 80-81, see also id. at 128-32.
Similarly, Dr. Kennedy opined that Respondent's treatment plans, as they were reflected in the reviewed records, were "grossly inadequate" in that the use of controlled substances was the single option considered and employed, "[s]o everybody got essentially the same treatment regardless of their complaint, severity, physical examination [and] history." Id. at 82-83. In Kennedy's view, combining controlled substance medications that were utilized in the charts was not "bad by itself, but it was done across the board with everybody. * * * [with] essentially the same drugs at the same doses for all the individuals" Id. at 98. In Dr. Kennedy's view, there were a panoply of other treatment options that could and should have been documented and discussed with the Respondent's pain patients. Id. 162-64.
Dr. Kennedy also made the ironic observation that although to the "extremely rare" \31\ extent controlled substance medication adjustments were ever effected by the Respondent, they went up, and the forms utilized by the Respondent (and the practice in general) only provided a checkbox for reduction, or weaning. Id. at 95-96. This is essentially inconsistent with the normal practice of starting controlled substance treatment at the lowest dose possible to attain the desired result and adjusting upwards. Id. The form used by the Respondent seems to presume that the controlled substance doses would generally progress downward. Dr. Kennedy testified that he saw no evidence of medication adjustment to accommodate treatment, or "titration," in any of the charts he examined. Id. at 174.
Although Dr. Kennedy conceded that it is the judgment of the examining physician that is generally relied upon in determining the necessity and appropriateness of diagnostic testing,\32\ he also testified that the Respondent's practice of routinely ordering magnetic resonance imaging (MRI) procedures before he met with the patients was inappropriate because an MRI is not always required and not always appropriate. Id. at 71-73, 153-54. In Kennedy's opinion, a physician has an obligation to meet with the patient before including this procedure as part of the utilized diagnostic tools. Id.
explained that a patient who has never had opioids, or has been off them for two to four weeks is classified as "opioid na[iuml]ve" and would feel the affects of the medication with smaller doses that can be increased as needed. Id. at 83-86. The dosage levels prescribed by the Respondent, in Dr. Kennedy's view, would always require significant monitoring of the medication's effect on the patient, generally done in an office or hospital, and not an outpatient setting. Id. at 86-88.
\33\ Dr. Kennedy testified that the recommended starting dosages are found in the medication product insert and divined through clinical knowledge. Tr. at 100.
\34\ At the request of the Government, a protective order was issued that is designed to minimize the risk of the dissemination of identifying information related to patients and their relatives associated with this case. Accordingly, initials have been substituted for the names of individuals within the protection of the protective order throughout the body of this decision. ALJ Ex. 15.
If the records that the patient filled out themselves [sic] are correct, then that especially given with the Xanax, which is a benzodiazepine like Valium[,] [i]ts generic name is alprazolam[,] [a]nd that's a high dose of Xanax as well.  [T]he typical starting dose of Xanax is .25 to 0.5 [mg]. So, that's four to eight times higher than the usual dose on that, and that's given twice daily. Given that they work different areas in the nervous system and they both can cause sedation and potentially respiratory depression, there's at least an additive if not a synergistic effect between when you mix different components of an opioid like oxycodone, a narcotic pain reliever, with a benzodiazepine like Xanax, alprazolam, especially at those doses in a na[iuml]ve person for both drugs, that makes it even more dangerous.
No sir, this isn't even close. There's no room, wiggle room on this. This is absolutely beyond the pale.
Notwithstanding his expressed concerns over the potency of some of the controlled substances prescribed by the Respondent, Dr. Kennedy was struck by the fact the charts of several of the Respondent's patients reflected no indication that any acceptable measure of mental status, cognitive ability and response time was undertaken. Id. at 102-07.
On cross-examination, Dr. Kennedy agreed that the reviewed charts reflected objective signs that arguably supported medically determinable impairments that could cause chronic pain conditions, and that the controlled substance medications that were prescribed by the Respondent were among those that could be correctly employed to treat chronic pain. Id. at 132-33, 135-37, 140-42, 144-45, 148-51. However, Dr. Kennedy remained steadfast in his dual views that the Respondent's medical records simply did not contain enough information for a physician to reach the conclusion that the prescribing was appropriate and that the medication doses were simply too high. Id. at 123, 126-27, 166. Kennedy was also consistent in his position that MRI results, standing alone, are not a reliable indicator of an impairment indicating the utilization of controlled substance medications. Id. at 55-63, 130-31, 164-66.
In his Patient Charts Analysis, Dr. Kennedy focuses on a patient chart related to GA, one of the Respondent's patients, and opines that the flaws identified in GA's chart are common to all fifteen of the Respondent's files that he reviewed. Specifically, the Patient Charts Analysis states that the charts he reviewed "are essentially the same with regard to review issues; as stated in the report of [GA] referenced and discussed in this report in detail, [and that] there were no significant differences that affected [his] conclusions and summary." Govt. Ex. 5 at 2.
\35\ Govt. Ex. 5 at 4.
\36\ Govt. Ex. 5 at 4. In Dr. Kennedy's opinion, the Respondent "prescribed, at the first visit, very high initial doses of controlled substance combinations despite being outside the bounds of professional practice for histories and physical examinations and absent past medical records." Id. at 7.
\37\ Govt. Ex. 5 at 4.
\38\ Govt. Ex. 5 at 3. As an example of the failure to adhere to the terms of the medication contract, Dr. Kennedy cites a contract term that provides notice that the physician may stop prescribing opioids or change treatment if pain or activity improvement is not demonstrated, and points out that pain and activity levels are routinely not documented in treatment notes. Id. at 4. Similarly, Dr. Kennedy references a medication contract warning that termination of services may result from failure to make regular follow-up appointments with primary care physicians, and notes that the American Pain charts contain no notes from primary care physicians or medical records generated by them. Id.
\39\ Govt. Ex. 5 at 7. In Dr. Kennedy's opinion, Respondent "in effect, acted as a 'barrier' for [GA] to receive appropriate medical evaluation and treatment. In other words, the very potent, high doses of opioids (oxycodone) and benzodiazepine (Xanax) could mask or cover up [GA's] underlying disease process(s), making them more difficult to diagnose, and allowing the disease(s) to unnecessarily worsen. Without an accurate diagnosis, all [the Respondent] was doing was, again, masking or covering up the symptoms." Id. at 10.
\40\ Govt. Ex. 5 at 7.
\41\ Govt. Ex. 5 at 7.
\42\ Govt. Ex. 5 at 7.
\43\ Govt. Ex. 5 at 15. The only past medical record contained in GA's chart was a report from an MRI conducted one day prior to the patient's initial office visit at American Pain. Id. at 8.
\44\ Govt. Ex. 5 at 14.
Dr. Kennedy found the Respondent's controlled substance patient monitoring to be deficient in numerous respects. From the reviewed patient charts, Dr. Kennedy gleaned that an initial, in-office urine drug screen was frequently executed during the patients' initial visit to the office but repeated only occasionally. Govt. Ex. 5 at 14. It was Dr. Kennedy's observation that even a drug screen anomaly did not alter the seemingly inexorable continuation of controlled substance prescribing from the Respondent. Id. Dr. Kennedy also noted that the Respondent did not utilize out-of-office toxicology tests, or obtain out-of-State prescription monitoring program or outside pharmacy drug profiles, and expressed concern that the in-house urinalysis documentation that was maintained did not provide sufficient detail regarding the procuring and maintaining of the sample to meaningfully gauge its reliability. Id.; Tr. at 107-111. Kennedy expressed his view that the whole drug testing process at the Respondent's office was inadequate. Furthermore, the charts contained only rare evidence of contact with primary care physicians, treating physicians, pharmacists, or other health care providers. Id.
The identified shortcomings of controlled substance patient monitoring systems was of particular significance where Dr. Kennedy identified specific evidence that he identified as "red flags" of possible or likely diversion. Red flags noted by Dr. Kennedy in the reviewed charts included the relatively young age of the Respondent's chronic pain patients,\45\ incomplete history information provided by the patients, periodically significant gaps between office visits,\46\ referrals from friends, relatives, or advertising, but not other physicians,\47\ and the fact that a relatively high number of patients were traveling significant distances to American Pain for pain treatment, although no physician employed at that facility had any specialized training in pain management.\48\ During his testimony, Dr. Kennedy conceded that, standing alone, the Respondent's treating out- of-State patients has no particular significance, and that when he was engaged in the practice of medicine in Kentucky he had patients who traveled to his office from Florida.\49\ Tr. at 116. Regarding the Respondent's Kentucky patients, Dr. Kennedy observed that there were numerous medical and osteopathic schools that were much closer to the homes of these patients that could have provided pain management. Id. at 116-17.
\45\ Govt. Ex. 5 at 15.
\46\ Govt. Ex. 5 at 13.
\47\ Govt. Ex. 5 at 7, 15.
\48\ Govt. Ex. 5 at 15; Tr. at 67-68.
\49\ Although the Government elicited testimony from Dr. Kennedy concerning his perceived significance to a "majority" of patients coming from out of State, Tr. at 116-17, since there was no evidence regarding what percentage of the Respondent's patients were from outside Florida, this inquiry and its responses have been given no weight.
\50\ Dr. Kennedy did not testify that a referral that emanated from a source other than a physician could or should be a basis for a diversion red flag on a given case. His opinion was limited to culling some manner of a trend or pattern. In view of the fact that the record contains no development of the numbers of files with non- physician referrals versus the total number of files, or even an acceptable metric upon which the issue could be evaluated, there is very little useful analysis that can come from Dr. Kennedy's observation regarding the files he reviewed.
During his testimony as well as his report, Dr. Kennedy highlighted several features of particular charts that, at least in his view, bore the indicia of some red flags that should have signaled an increased risk of controlled substance diversion. Kennedy detailed several controls that should have been, but were apparently not utilized by the Respondent to monitor diversion risks in a pain management practice. Id. at 111. Some examples of expected diversion controls that were available to, yet absent from the Respondent's practice included random pill counts, communication with family members, blood tests to supplement urinalysis drug screens, communication with patient pharmacists and the acquisition of pharmacy readout sheets to evaluate the prescriptions filled and sources of those prescriptions, and the acquisition of printouts from prescription monitoring programs (PMPs) in some of the States \51\ where his patients resided. Id. at 111-13.
\51\ Dr. Kennedy testified that although Florida does not have a PMP, several of the States where some of the Respondent's patients resided did have such programs, and that the Respondent would have had access to obtain information about his patients in this manner. Tr. at 113.
files with respect to those drugs present on UDS in comparison to current medications listed in medication contract and other forms). Patient BS's UDS indicates a negative test for all listed substances, yet on two different forms she indicates she is currently taking two strengths of Roxycodone along with Xanax. Govt. Ex. 16 at 6-7, 18. A prescribed controlled substance that is not reflected in a drug screen should have raised a sufficient suspicion of diversion to merit further inquiry by the registrant reflected in the patient file. The UDS form in patient TS's file reflects circled positive results for benzodiazepines, opiates, and oxycodone on "2/12," yet the words "Neg Test" is handwritten and circled in the margin. Govt. Ex. 13 at 9. Numerous patient files also reflected notations that patients "requested" specific types and/or strengths of controlled substances. Govt. Exs. 6 at 6; 7 at 2; 8 at 4; 17 at 2; 20 at 3; 21 at 3. At a minimum, these observations support the conclusion there was a general lack of vigilance on the part of the Respondent regarding his obligations as a registrant to minimize the risk of controlled substance diversion.
\52\ The Government's tactical decision to essentially unload a pile of charts that are explained only by the representations and generalizations in a report, with no attempt whatsoever to have its expert witness explain the applicable aspects of most charts to this tribunal or any future reviewing body is clearly at odds with the directive provided by the Deputy Administrator in Gregg & Son Distributors that "it is the Government's obligation as part of its burden of proof and not the ALJ's responsibility to sift through the records and highlight that information which is probative of the issues in the proceeding." 74 FR 17517 n.1.
Interestingly, in his report, Dr. Kennedy also found it remarkable that each American Pain patient file provided notice to its patients that American Pain did not accept any form of health care insurance. Govt. Ex. 5 at 3, 16. The report reflected Kennedy's view that this practice was designed to "effectively keep [the physicians at American Pain] 'off the radar' from monitoring by any private health care insurance company as well as all State and Federal agencies (Medicaid and Medicare respectively)." Id. at 16. Significantly, however, when asked, Dr. Kennedy acknowledged that he conducts his own current medical practice on a cash-only basis. Tr. at 151.
Govt. Ex. 5 at 16.
The Government's presentation of Dr. Kennedy's testimony at the hearing was substantially consistent with the conclusions included in the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly not without its blemishes. Although he testified that he was familiar with prescribing practices in Florida, and that he utilized the medical standards applicable to Florida practice,\53\ he was unable to identify the documentation standard in the Florida Administrative code with any degree of particularity, and he also acknowledged that he was not aware of what the standard is in Florida Medical Board administrative decisions regarding the overprescribing of medication or what constitutes an adequate medical history. Tr. at 149-51, 233, 304. While, overall, Kennedy presented testimony that appeared candid and knowledgeable, there were areas in his written report that rang of hyperbole and over-embellishment. The reasoning behind some of the seemingly critical observations in the written report, such as the "cash basis" of the Respondent's practice and the absence of doctor referrals among the reviewed patient files, did not well survive the crucible of cross examination at the hearing. However, overall, Dr. Kennedy's testimony was sufficiently detailed, plausible, and internally consistent to be considered credible, and, consistent with his qualifications, he spoke persuasively and with authority on some relevant issues within his expertise, and notwithstanding the Respondent's objections relative to his Florida-related experience, he is currently an assistant professor teaching at a Florida Medical School. It may well be that the greatest and most significant aspect of Dr. Kennedy's opinion is that on the current record, it stands unrefuted. Thus, his opinion is the only expert opinion available for reliance in this action.\54\ Dr. Kennedy testified that based on his review of the selected patient charts from the Respondent's medical practice, in his expert opinion, he "couldn't find any legitimate basis for [the Respondent] prescribing medications to any of the [patients] and that the Respondent's prescribing practices "were not in compliance at all from the very first visit on" with the standards set forth by the Florida Medical Board. Id. at 118. Accordingly, Dr. Kennedy's expert opinion that the Respondent's controlled substance prescribing practices, at least as evidenced through his examination of the patient charts he reviewed, fell below the standards applicable in Florida, and that the controlled substance prescriptions contained in those files were not issued for a legitimate medical purpose is unrefuted on this record and (although by no means overwhelming) is sufficiently reliable to be accepted and relied upon in this recommended decision.
\54\ The Respondent did not testify on his own behalf.
\55\ This authority has been delegated pursuant to 28 CFR 0.100(b) and 0.104.
Deputy Administrator is not required to discuss consideration of each factor in equal detail, or even every factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988) (the Administrator's obligation to explain the decision rationale may be satisfied even if only minimal consideration is given to the relevant factors and remand is required only when it is unclear whether the relevant factors were considered at all). The balancing of the public interest factors "is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest * * * ." Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
In this case, it is undisputed that the Respondent holds a valid and current State license to practice medicine. The record contains no evidence of a recommendation regarding the Respondent's medical privileges by any cognizant State licensing board or professional disciplinary authority. However, that a State has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest. Patrick W. Stodola, M.D., 74 FR 20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR at 461. It is well- established Agency precedent that a "state license is a necessary, but not a sufficient condition for registration." Leslie, 68 FR at 15230; John H. Kennedy, M.D., 71 FR 35705, 35708 (2006). Even the reinstatement of a State medical license does not affect the DEA's independent responsibility to determine whether a registration is in the public interest. Mortimer B. Levin, D.O., 55 FR 9209, 8210 (1990). 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 FR 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (DC Cir. 2008), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). Congress vested authority to enforce the CSA in the Attorney General and not State officials. Stodola, 74 FR at 20375. Thus, on these facts, the fact that the record contains no evidence of a recommendation by a State licensing board does not weigh for or against a determination as to whether continuation of the Respondent's DEA certification is consistent with the public interest.
that indicated that a criminal search warrant was executed regarding the Respondent and American Pain, the record contains no evidence that the Respondent has ever been convicted of any crime or even arrested in connection with any open criminal investigation. Thus, consideration of the record evidence under the first and third factors does not militate in favor of revocation.
In this case, the Respondent introduced no evidence regarding his level of knowledge and experience, or even the quality or length of his experience as a physician-registrant, but the Government has elected to do so.
be presenting the testimony of Intelligence Analyst (IA) Janet Hines, who would relate her encounter with a confidential source who allegedly obtained controlled substances from the Respondent with minimal or no physical examinations and intentionally diverted them. ALJ Ex. 6. The Government never called IA Hines and never offered an explanation for the differences between the expansive proffers and the less-expansive ultimate presentation.
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing \56\ controlled substances), but also Factors 4 (compliance with Federal and State law relating to controlled substances) and 5 (other conduct which may threaten public health and safety). Succinctly put, the Government's evidence related to the manner in which the Respondent practiced, and whether his practice complied with the law and/or was a threat to the public.
\56\ The statutory definition of the term "dispense" includes the prescribing and administering of controlled substances. 21 U.S.C. 802(10).
While true that GS Langston convincingly testified about the course of her investigation and laid an adequate foundation for numerous database results, the Government provided no foundational context for any relevant uses for those database results. Without some insight into what types of results from these databases should be expected when compared to similarly-situated registrants engaged in acceptable prescribing practices, the raw data is without use. In short, there was no evidence elicited wherein the percentage of the Respondent's in- State to out-of State patients could be assessed, and no reasonable measuring stick based on sound principles upon which to evaluate such data. Likewise, there was no reliable yardstick upon which to measure the amount of controlled substances reflected in the databases compared to what a reasonable regulator would expect to see regarding a compliant registrant. To the extent Langston possessed this information (and she well may have) it was not elicited from her. The same could be said of the allegation set forth in the Government's Prehearing Statement that alleges that from a given period the Respondent "was the 16th largest practitioner purchaser of oxycodone in the United States." \57\ No evidence to support that allegation (or its relevance) was ever brought forth at the hearing. To the extent that fact may have been true or relevant, it was never developed. What's more, as ably pointed out by Respondent's counsel,\58\ the Florida Administrative Code specifically eschews pain medication prescribing analysis rooted only in evaluation of medication quantity. Fla. Admin. Code r. 64B8-9.013(g).\59\ Lastly, there was no indication that despite Langston's obvious qualifications to do so, that she or anyone else ever conducted an audit of the controlled-substance-inventory-related recordkeeping practices at American Pain.
\57\ ALJ Ex. 6 at 11-12.
\58\ Respt's Br. at 20.
\59\ The Respondent's brief incorrectly sites subsection (f).
SA Burt testified that, during a temporally limited period of time, he observed some of the images captured by a pole camera positioned outside American Pain, and that he observed what in his view was a high percentage of vehicles in the parking lot with out-of-State license tags. This testimony arguably provides some support for the Government's contention that out-of-State patients (or at least patients being dropped off by cars with out-of-State tags) were being seen at the clinic, but his testimony did not provide much else in terms of relevant information. In any event, recent Agency precedent holds that details such as "where [a registrant's] patients were coming from," without additional factual development, can support a "strong suspicion that [a] respondent was not engaged in a legitimate medical practice" but that "under the substantial evidence test, the evidence must 'do more than create a suspicion of the existence of the fact to be established."' Alvin Darby, M.D., 75 FR 26993, 26999, n.31 (2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 292, 300 (1939).
Likewise, without additional details or at least some context, Burt's testimony that individuals with "staff" written on their shirts appeared to be directing patients into the clinic reveals virtually nothing about the Respondent's prescribing practices. Tr. 818, 910. Furthermore, that Burt observed an individual on a videotape, who he believed to be an American Pain employee, on a single occasion, instruct patients not to "snort [their] pills" in the parking lot,\60\ or advising them to comply with vehicle and traffic laws,\61\ does not shed illumination on the Respondent's prescribing practices. There was no evidence that the Respondent knew that these isolated incidents occurred, nor was there contextual evidence from which the relevance to these proceedings could be gleaned. Even if this tribunal was inclined to engage in the unsupported assignment of motives to the actions of these employees, under these circumstances, such an exercise could not constitute substantial evidence that could be sustained at any level of appeal.
Burt's testimony regarding his conversations with Dr. Sollie, who was formerly employed by American Pain, were also not received in a manner that could meaningfully assist in the decision process. According to Burt, Sollie told him that some (unnamed) physicians at American Pain were inadequately documenting their patient charts in some manner that was apparently never explained to Burt,\62\ and that some patients were intentionally evading the American Pain urinalysis process. Sollie did not work at American Pain at the same time the Respondent did, and did not specifically name any physician as being connected with his allegations of misconduct. Thus, this tribunal is at something of a loss as to how the information, as presented, would tend to establish a fact relevant to whether the continuation of the Respondent's authorization to handle controlled substances is in the public interest.
illegitimate traffic in controlled substances, "Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA." Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the maintenance of that closed regulatory system, subject to limited exceptions not relevant here, a controlled substance may only be dispensed upon a prescription issued by a practitioner, and such a prescription is unlawful unless it is "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 U.S.C. 829; 21 CFR 1306.04(a). Furthermore, "an order purporting to be a prescription issued not in the usual course of professional treatment * * * is not a prescription within the meaning and intent of [21 U.S.C. 829] and the person knowingly * * * issuing it, shall be subject to the penalties provided for violations of the provisions of law related to controlled substances." Id.
A registered practitioner is authorized to dispense,\63\ which the CSA defines as "to deliver a controlled substance to an ultimate user \64\ * * * by, or pursuant to the lawful order of a practitioner." 21 U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040 (2007). The prescription requirement is designed to ensure that controlled substances are used under the supervision of a doctor, as a bulwark against the risk of addiction and recreational abuse. Aycock, 74 FR at 17541 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006); United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting that evidence established that a physician exceeded the bounds of professional practice when he gave inadequate examinations or none at all, ignored the results of the tests he did make, and took no precautions against misuse and diversion)). The prescription requirement likewise stands as a proscription against doctors "peddling to patients who crave the drugs for those prohibited uses." Id. The courts have sustained criminal convictions based on the issuing of illegitimate prescriptions where physicians conducted no physical examinations or sham physical examinations. United States v. Alerre, 430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 1113 (2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986).
\64\ "Ultimate user" is defined as "a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household." 21 U.S.C. 802(27).
\65\ Rulemaking authority regarding the practice of medicine within the State of Florida has been delegated to the Florida Board of Medicine (Florida Board). Fla. Stat. Sec. 458.309(1) (2009).
(4) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered in to the record * * * .
reasonably prudent physician under similar conditions and circumstances.
\66\ Florida defines "intractable pain" to mean "pain for which, in the generally accepted course of medical practice, the cause cannot be removed and otherwise treated." Fla. Stat. Sec. 458.326 (2009).
Fla. Stat. Sec. 458.326 (2009). Moreover, the Florida Board has adopted,\67\ albeit in modified version, the Model Policy for the Use of Controlled Substances for the Treatment of Pain (Model Policy), a document drafted by the Federation of State Medical Boards (FSMB) to provide professional guidelines for the treatment of pain with controlled substances. The standards adopted by Florida share the key tenants of the Model Policy's standards for pain management prescribing, including the emphasis on diligent efforts by physicians to prevent drug diversion, prescribing based on clear documentation of unrelieved pain and thorough medical records, and compliance with applicable Federal and State law.
\67\ Pursuant to authority vested in the Florida Board by the Florida legislature to promulgate rules regarding State standards for pain management clinical practice specifically. Fla. Stat. Sec. 458.309(5) (2009).
Like the Model Policy, which was promulgated "to encourage the legitimate medical uses of controlled substances for the treatment of pain while stressing the need to safeguard against abuse and diversion," Florida's regulation providing "Standards for the Use of Controlled Substances for Treatment of Pain," Fla. Admin. Code r. 64B8-9.013 (2009) (Florida Standards), recognizes that "inappropriate prescribing of controlled substances * * * may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use." The language employed by the regulation under the preamble section titled "Pain Management Principles" makes clear that the standards "are not intended to define complete or best practice, but rather to communicate what the [Florida Board] considers to be within the boundaries of professional practice" (emphasis supplied), id. at 9.013(1)(g); thus, the plain text supports an inference that the standards provide the minimum requirements for establishing conduct that comports with the professional practice of controlled substance- based pain management within the State. Likewise, the level of integral range of acceptable practice that is built into the regulation underscores the importance of seeking an expert professional opinion in reaching a correct adjudication of whether a registrant has met the applicable Florida standard. It is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice," \68\ resort must be had to an expert.
A complete \69\ medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
\69\ The original Model Policy version of the guidelines does not contain a reference to the need for a complete medical history, instead only requiring a medical history generally. Thus, the Florida Board has adopted a higher standard than the measure that has been set in the Model Policy by the FSMB.
It is abundantly clear from the plain language of the Florida Standards that the Florida Board places critical emphasis on physician implementation of adequate safeguards in their practice to minimize diversion and the need to document the objective signs and rationale employed in the course of pain treatment utilizing the prescription of controlled substances. Conscientious documentation is repeatedly emphasized as not just a ministerial act, but a key treatment tool and a vital indicator to evaluate whether the physician's prescribing practices are "within the usual course of professional practice." Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert witness to testify at these proceedings, reflects that the documentation he reviewed in the Respondent's patient charts reflected care that was markedly below the standard of care set by the Florida Medical Board. Dr. Kennedy's expert assessment was consistent with the State statutory and regulatory guidance. In Kennedy's view, the Respondent's charts demonstrated minimalistic, incomplete, and otherwise medically inadequate documentation of his contacts with patients and the prescribing rationale for his issuance of controlled substance prescriptions to those patients for alleged pain management purposes. The boilerplate-style, "one high-dosage controlled substances treatment plan fits all" nature of nearly all of the patient medical records at issue, at least in the view of the uncontroverted expert, evidences a failure on the part of the Respondent to conduct his practice of medicine in a manner to minimize the potential of controlled substance abuse and diversion, and supports a conclusion that he failed to even substantially comply with the minimum obligations for professional practice imposed under the Florida Standards--and without "good cause  shown for such deviation." Id. at 9.013(1)(f).
In his Argument, Proposed Findings of Fact and Proposed Conclusions of Law (Respondent's Brief), the Respondent's counsel has prepared and submitted a thoughtful and detailed analysis of the counsel's application of the relevant standards in Florida to the charts analyzed by Dr. Kennedy. Respt's Br. at 3-17. Unfortunately, counsel's analysis is the product of a lay evaluation of standards applicable to the nuanced and sophisticated science that is the practice of medicine. Where his opinion and that of the only accepted medical expert to provide an expert opinion conflict, his opinion cannot and will not be afforded controlling deference. Argument supplied by counsel (albeit a diligent and persuasive counsel) that the relevant standards were satisfactorily applied as evidenced by the protocols and procedures documented in the patient charts cannot supplant the unrefuted view of an accepted expert witness.
The Respondent, who was in a unique position to conclusively refute Dr. Kennedy's views and explain the format and nuances of the reviewed documentation, elected not to testify in this matter. At a DEA administrative hearing, it is permissible to draw an adverse inference from the silence of the Respondent, even in the face of a Fifth Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) (citing United States v. Hale, 422 U.S. 171, 176 (1975) ("silence gains more probative weight where it persists in the face of accusation, since it is assumed in such circumstances that the accused would be more likely than not to dispute an untrue accusation.")); Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts of this case, where the allegations are of a nature that a registrant would be more likely than not to dispute them if untrue, an adverse inference based on the Respondent's silence is appropriate. Where, as here, the Government, through its expert, has alleged that the Respondent's charts do not reflect genuine analysis, but rather (at least in its view and the opinion of its expert), a sort of sham-by- check-box form designed specifically to present a false impression of a compliant registrant, it is precisely the type of allegation that would naturally all but oblige a registrant to spring to offer a contradictory account. The Respondent's choice to remain silent in the face of such allegations, where he could have related his version of his practice as a registrant, adds at least some additional credence to the factual and analytical views of the Government's expert in this regard.
Respondent's counsel, or any other lay source would be a dangerous course and more importantly, a plainly erroneous one.
The evidence establishes that the Respondent engaged in a course of practice wherein he prescribed unsafely high doses of controlled substances to patients irrespective of the patients' need for such medication and ignoring any and red flags that could or did indicate likely paths of diversion. The testimony of Dr. Kennedy, the DEA regulations, and the Florida Standards make clear that physicians prescribing controlled substances do so under an obligation to monitor the process to minimize the risk of diversion. The patient charts reflect that the Respondent, contrary to his obligations as a DEA registrant, did not follow up in the face of multiple red flags. The Respondent's disregard of his obligations as a DEA registrant and Federal and State laws related to controlled substances militate in favor of revocation.
By routinely prescribing unsafely high doses of controlled substances to opioid-na[iuml]ve patients and ignoring his responsibilities to monitor the controlled substance prescriptions he was authorizing to minimize diversion, and by participating in an insufficiently documented and thoughtful process for the issuance of potentially dangerous controlled substances, the Respondent created a significant potential conduit for the unchecked diversion of controlled substances. See Holloway Distrib., 72 FR at 42124 (a policy of "see no evil, hear no evil" is fundamentally inconsistent with the obligations of a DEA registrant). Agency precedent has long recognized that "[l]egally, there is absolutely no difference between the sale of an illicit drug on the street and the illicit dispensing of a licit drug by means of a physician's prescription." EZRX, LLC, 69 FR 63178, 63181 (1988); Floyd A. Santner, M.D., 55 FR 37581 (1988).
Based on the foregoing, the evidence supports a finding that the Government has established that the Respondent has committed acts that are inconsistent with the public interest. A balancing of the statutory public interest factors supports the revocation of the Respondent's Certificate of Registration and a denial of his application to renew. The Respondent has not accepted responsibility for his actions, expressed remorse for his conduct at any level, or presented evidence that could reasonably support a finding that the Deputy Administrator should continue to entrust him with a Certificate of Registration.

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