Source: https://www.deadiversion.usdoj.gov/fed_regs/actions/2011/fr0407_4.htm
Timestamp: 2019-04-25 16:26:22+00:00

Document:
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.
Dr. Kennedy has published several articles and book chapters on pain management issues and has made several dozen presentations on pain management issues at professional meetings.\4\ Id. at 3-7. In addition, he is a member of several professional organizations including the American Academy of Pain Medicine, the American Board of Pain Medicine, the American Pain Society, the International Association for the Study of Pain, the American Society of Addiction Medicine, the American Board of Anesthesiology, and the American Society of Anesthesiology. Id. at 10; Tr. 22. Finally, Dr. Kennedy explained that he was familiar with the Florida Board of Medicine's standards for prescribing controlled substances to treat pain and that he had reviewed them prior to preparing his report. Tr. 24-26; GX 101, at 6-7.
Thus, Dr. Kennedy was clearly qualified to provide expert testimony. I therefore agree with the ALJ that Dr. Kennedy's testimony was sufficiently reliable to constitute substantial evidence on the issue of whether Respondent acted within the usual course of professional practice and had a legitimate medical purpose in prescribing controlled substances to the patients whose files he reviewed and reject this exception. ALJ at 17.
Next, Respondent contends that Dr. Kennedy's opinion testimony is entitled to no weight because it was based on only sixteen patient charts, which Respondent maintains were not randomly selected and is too small a sample to draw sufficient conclusions about the validity of his prescribing practices. Resp. Exc. at 2. In support of this contention, Respondent relies on Dr. Kennedy's testimony that "'[i]t might not be fair'" to "'cherry-pick'" sixteen charts out of a physician's patients because those might be the "the only people out of 2,000" and that the problems found would "be 'an administrative issue for education with the Board of Medical License and not'" necessarily justify the revocation of Respondent's medical license (or DEA registration). Id. (quoting Tr. 612-13).
However, even acknowledging that one of the sixteen files reviewed by Dr. Kennedy with respect to Respondent was not randomly selected because it was that of an undercover officer, the ALJ found credible the Diversion Investigator's testimony that the files were not specially selected to enhance the strength of the Government's case. ALJ at 5 (citing Tr. 768). More importantly, the requirement of Federal law that a prescription "must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice," 21 CFR 1306.04(a), applies to each and every prescription issued by a practitioner. Thus, contrary to the Expert's understanding, in determining whether a practitioner has committed acts which render his "registration inconsistent with the public interest," 21 U.S.C. 824(a)(4), DEA is not required to randomly select the files which it will base its case on.
For example, where the Government has developed information that particular patients are drug dealers or engaged in self-abuse, it is not required to ignore the files pertaining to these patients and base its case on a random sample of files. Rather, it can lawfully select the files pertaining to those patients and base its case entirely on them. 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. Of course, where, as here, the Government's case relies so heavily on a chart review, the practitioner can put on his own evidence and argue that the Government's evidence does not establish that he violated the prescription requirement or that his conduct was not so egregious as to warrant revocation. See Paul Caragine, 63 FR 51592 (1998). See also Dewey C. MacKay, 75 FR at 49977; Krishna-Iyer, 74 FR at 463 (holding that DEA can revoke based on a single act of diversion); Medicine Shoppe-Jonesborough, 73 FR at 386 & n.56.\5\ Accordingly, there is no merit to Respondent's contention.
\5\ Consistent with DEA's longstanding precedent, see ALJ at 19, a respondent is also entitled to put on evidence as to his acceptance of responsibility and any remedial measures he has undertaken to prevent the re-occurrence of similar acts.
patient's intensity of pain, current and past treatments for pain, and the effect of pain on physical and psychological function." Id. at 4. He further argues that "[h]e set out a written treatment plan, discussed the risks and benefits of controlled substances and conducted periodic reviews" as also required by Florida's regulations. Id. at 4- 5.
While it is true that Dr. Kennedy acknowledged that he was not familiar with the specific standard imposed by the State of Florida for excessive prescribing and that he had not reviewed any Florida Medical Board decisions addressing the issue of what is an adequate medical history, see ALJ at 17; as noted above, in his report Dr. Kennedy discussed at length the Florida Board of Medicine's Standards for the Use of Controlled Substances for the Treatment of Pain, Fla. Admin. Code 64B8-9.013. See GX 101, at 6-7.\6\ Nor did Respondent produce any evidence that his recordkeeping and prescribing complied with the standards of the Florida Medical Board. Moreover, there is substantial evidence to support the conclusion that Respondent was not engaged in legitimate medical practice and was diverting drugs.
\6\ Even after Gonzales v. Oregon, 546 U.S. 243 (2006), multiple courts of appeals, including the Eleventh Circuit, "have applied a general-practice standard when determining whether the practitioner acted in the 'usual course of professional practice.'" United States v. Smith, 573 F.3d 639, 647-48 (8th Cir. 2009); see also id. at 648 (discussing United States v. Moore, 423 U.S. 122 (1975); "Thus informed by the Supreme Court and other controlling and persuasive precedent, we believe that it was not improper to measure the 'usual course of professional practice' under Sec. 841(a)(1) and [21 CFR] 1306.04 with reference to generally recognized and accepted medical practices * * *."). Likewise, the Eleventh Circuit has held that "[t]he appropriate focus * * * rests upon whether the physician prescribes medicine 'in accordance with a standard of medical practice generally recognized and accepted in the United States.'" United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 2008) (quoting Moore, 423 U.S. at 139).
As Dr. Kennedy explained, most of the patients were from out-of- state, with some travelling up to 1200 miles,\7\ even though Respondent had no specialized training in pain management, and yet, Respondent did not obtain reports from the prescription monitoring programs run by the States where his patients lived. Id. at 16-17. Moreover, Respondent did not obtain adequate medical histories and perform adequate physical examinations; he also never obtained medical records from other treating physicians (or even contacted them) for any of the patients whose files are in evidence. Id. at 14-17.
\7\ Of the sixteen patients, only five were from Florida. Of the remaining patients, five were from Kentucky, two were from Tennessee, and one was from each of the following States: North Carolina, Ohio, Massachusetts, and Georgia. GX 101, at 9.
As Dr. Kennedy explained, while "[t]he chart was set up to give the appearance of a legitimate medical practice in an attempt to justify the initial and continued prescription and dispensing of high dose multiple controlled substances ('drug cocktails')," and that while "on the surface [the charts] were adequate for evaluating and treating a patient," on closer review, "the actual contents in the charts, clearly evidence just the opposite" as the charts "were very difficult * * * to read [with] many sections left blank or incompletely filled in." Id. at 17. Continuing, Dr. Kennedy explained that "[t]he notes were not within the standard of care; all were outside the boundaries of professional practice, lacking significant information and ignoring significant history that was present." Id. Moreover, Respondent's failure to obtain patients' medical records "was well outside the boundaries of medical practice and below the standard of medical care," especially for patients receiving "very high dose[s]" of controlled substances. Id.
The evidence further shows that this case is not simply a matter of inadequate record keeping. While Respondent apparently required his patients to obtain an MRI, in multiple instances the MRI was obtained before the patient was even evaluated by Respondent, and generally, no other imaging studies such as x-rays or CT scans were done.\8\ Id. at 16. Moreover, Respondent rarely referred a patient to another physician or health care professional for a consultation.\9\ As Dr. Kennedy explained, "alternative opinions should have been sought in order to better diagnose and treat; not to do so was outside the boundaries of professional practice and not within the standard of care." Id. Dr. Kennedy thus concluded that Respondent's "diagnoses were usually very vague and/or without medical merit" and were done in an "attempt to justify what controlled substances he prescribed." Id. at 17.
\8\ Dr. Kennedy explained that referring a patient to obtain an MRI prior to having some contact is unusual and medically inappropriate. Tr. 71-72.
\9\ While Respondent referred one patient to his primary care physician for jaundice, and another to the Emergency Room to be evaluated for cellulitis, according to their respective medical records, both of these patients went to Respondent because of lower back pain. See GX 108, at 9; GX 109, at 1.
Dr. Kennedy further observed that while Respondent performed urine drug screens, he ignored the results even when they were inconsistent with other information provided by the patients such as when a patient tested positive for controlled substances which he had previously indicated that he was not currently taking. Id. at 14-15; ALJ at 15-16. Moreover, the drug screens were rarely performed other than at the patient's initial visit and lacked quality controls.\10\ GX 101, at 15.
\10\ Dr. Kennedy explained that the urine drug screens did not indicate the temperature and specific gravity of the specimen, whether the giving of the sample had been observed, or the type of drug screen used. GX 101, at 4; Tr. 100-03.
Also, although the charts indicate that Respondent discussed doing yoga and stretching, using an anti-inflammatory diet, and taking several over-the-counter supplements (fish oil and glucosamine chondroitin), Respondent's treatment plan primarily involved prescribing "drug cocktails" of high doses of controlled substances with the same regimen of drugs (typically two strengths of oxycodone immediate release and Xanax) prescribed in nearly every case. Id. at 5, 13, 15. Most significantly, Respondent never referred any of the sixteen patients for consultations with specialists related to their pain complaints, or for physical, occupational or mental health therapy. GX 101, at 13.
Dr. Kennedy further observed that while the typical starting dose of Xanax is 0.25 to 0.5 mg., once to twice per day, Respondent prescribed Xanax 2 mg., once or twice per day to fourteen of the sixteen patients, and he did so even with patients who had not been on the drug either "before or recently" and "no matter the age or clinical situation." Id. While Xanax is used as an anti-anxiety agent, Respondent's medical records did not support the prescribings because "[h]e did not list important factors that could cause anxiety * * * such as depression, life stressors, psychosocial situation, caffeine intake, sleep disturbance [and a] previous medical evaluation"; he also did not refer these patients for evaluation by a mental health professional. Id. And with respect to J.S., Dr. Kennedy concluded that Respondent's prescribing of this very high dose of Xanax "was clearly not within the boundaries of professional practice." Id.
one tablet to be taken every four hours), as well as sixty Roxicodone 15 mg. (one tablet, twice a day, as needed for pain), an amount that is seven times the usual starting dose. Id. at 19. While J.S. had noted on his medication contract that three months earlier, he had been prescribed 210 oxycodone 30 mg., 90 oxycodone 15 mg., and 90 Xanax 2mg., which was "almost exactly what [Respondent] prescribed[,]" Respondent did not identify the name of the physician who had issued the prescriptions and did not attempt to confirm them. Id. at 11.
At each of J.S.'s subsequent visits, Respondent prescribed an additional thirty tablets of oxycodone 30 mg. (for a total of 210), along with sixty tablets of oxycodone 15 mg. and 60 tablets of Xanax 2 mg. Id. at 19. While Dr. Kennedy acknowledged that prescribing an additional strength of oxycodone could be legitimate if it was done to treat breakthrough or episodic pain on an as-needed basis, with respect to J.S., who received prescriptions for oxycodone 30 mg. and 15 mg., "there was no specific reason stated in the medical record" for prescribing both drugs. Id. at 12. And with respect to all of the patients whose files he reviewed, Dr. Kennedy explained that Respondent's prescribing of drug cocktails of "a very high dose opioid" (including two forms of oxycodone) and a "high dose * * * benzodiazepine" (Xanax) lacked "any legitimate medical purpose." Id. at 15.
As Dr. Kennedy concluded, Respondent "was not engaged in the practice of medicine," and "[t]he vast majority of [his] prescriptions for controlled substances was not for a legitimate medical purpose and w[as] beyond the boundaries of professional practice." Id. at 18. His "routine and excessive prescription of multiple controlled substances * * * and lack of arriving at a valid medical diagnosis and treatment most likely caused harm to the patients he saw as well as * * * to other people in their communities." Id. I thus reject this exception as well.
Finally, I also reject Respondent's exception to the ALJ's ultimate finding that Respondent has committed acts which render his registration inconsistent with the public interest. Resp. Exc. 5. Because the record establishes that Respondent has repeatedly violated Federal law by issuing controlled substance prescriptions which lacked a legitimate medical purpose and were issued outside of the usual course of professional practice, 21 CFR 1306.04, and Respondent has offered no evidence establishing that he has accepted responsibility for his misconduct and that he has reformed his practice, see Steven M. Abbadessa, 74 FR 10077, 10081 (2009), I adopt the ALJ's recommendation that Respondent's registration be revoked.
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, FD1201196, issued to Roni Dreszer, M.D., be, and it hereby is, revoked. I further order that any pending application of Roni Dreszer, M.D., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.
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 FD1201196, of Roni Dreszer, 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 sought 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 22, 2010, the Respondent timely requested a hearing, which, pursuant to a change of venue granted at his request was conducted in Miami, Florida, on July 7, 2010 through July 9, 2010.\11\ The immediate suspension of the Respondent's COR has remained in effect throughout these proceedings.
\11\ Pursuant to an order issued on April 15, 2010, with the consent of the Respondent, the hearing in this matter was consolidated with the cases of four other registrants who were working at the same clinic as the Respondent and who were also issued OSC/ISOs on February 25, 2010, alleging similar and related conduct.
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, 2011.
The OSC/ISO issued by the Government alleges that the Respondent, through the medical practice he participated in at American Pain, LLC (American Pain), prescribed and dispensed inordinate amounts of controlled substances, primarily oxycodone,\12\ under circumstances where he knew, or should have known, that the prescriptions were not dispensed for a legitimate medical purpose. ALJ Ex. 1. The OSC/ISO further charges that these prescriptions were issued outside the usual course of professional practice based on a variety of circumstances \13\ surrounding the manner in which American Pain is operated and the manner in which its physicians, including Respondent, engaged in the practice of medicine. Id. Respondent is also alleged to have provided undercover law enforcement personnel with controlled substances, including, inter alia, oxycodone and alprazolam,\14\ after cursory or no medical examinations, and therefore without a legitimate medical purpose. Id. The Government also alleges 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 the intention of selling the controlled substances and/or personally abusing the drugs." Id.
\14\ A schedule IV controlled substance.
Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
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.\15\ Id. at 721. Under Langston's supervision, DEA diversion investigators catalogued the prescriptions seized at Boca Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. However, inasmuch as the Boca Drugs Prescription Log fails to distinguish between the Respondent, and another registrant with the same last name, the document is of no utility in reaching a disposition of the present case.
\15\ 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.
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.\17\ Govt. Ex. 119 at 2.
\17\ 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) and testified that she generated an ARCOS report relative to the Respondent's ordering of controlled substances from January 2009 through February 2010. Govt. Ex. 97.
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, Kentucky, and Ohio. Govt. Exs. 98-100. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 167 controlled substance prescriptions issued over the Respondent's signature to fifty-four patients located in West Virginia, 110 similar prescriptions provided to fifty-seven Kentucky-based patients were filled between January 1, 2009 and April 4, 2010, and sixty-six such prescriptions pertaining to twenty-eight patients located in Ohio were filled between April 1, 2008 and April 19, 2010. Id.
\18\ Remarkably, although this unfortunate aspect of this document was brought to light during the course of the hearing, Tr. at 732, no effort on the part of the Government was made to provide additional details or explanation that might tend to differentiate between the respondents.
he surveilled the Boca Raton and Lake Worth locations both in person and by periodic live review of video captured via pole cameras \19\ 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.
\19\ SA Burt described the pole cameras as "covert cameras that are installed to observe the activity in the clinic." Tr. at 816. Burt testified that he was able to use a laptop to access the live video feed from the cameras after inputting a username and password. The camera video was also recorded to DVR. Id. at 821.
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 \20\ 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.
Based on his review of some (but not all) \21\ of the audio and video tapes made by agents and informers sent into the clinic by the Government at various times, SA Burt also testified about his understanding of the process by which patients obtained controlled substance prescriptions at American Pain. According to Burt, after entering the clinic, a patient would meet with the receptionist, who would determine if the patient had an MRI. If not, the receptionist would issue that individual an MRI prescription in exchange for a $50 cash payment, and the patient "would be directed to a place to obtain an MRI." Id. at 822. Burt testified that one such MRI location was Faye Imaging, which was a mobile MRI trailer located behind a gentlemen's club several miles away from American Pain. Id. at 822-23. The cost for the MRI was $250, and the patient could pay an additional fee "to have the MRI expedited and faxed over to American Pain." Id. at 823-24. Once the MRI was procured and faxed to American Pain, the patient would return to the clinic and be seen by a doctor. According to Burt, the clinic accepted what he referred to as "predominantly cash only" \22\ for these office visits, and the six doctors at the clinic saw "anywhere from 200 upward to 375 patients a day" \23\ in this manner.\24\ Id. at 882-83 (emphasis supplied).
\21\ SA Burt conceded that although he is the designated lead case agent for DEA, he did not review all the audio and video tapes made in the case or even review the transcripts. Tr. at 1002-05.
\22\ Later on cross-examination, SA Burt admitted that the clinic also accepted payment via credit card. Tr. at 916.
\23\ Inasmuch as the Government provided no information from which any specific number of patients seen by any given clinic doctor on any day could be derived, or any expert testimony regarding a reasonable number of pain patients that could or should be seen per day, the value of providing the raw number of patients walking through the door at the clinic is negligible.
\24\ 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. 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 his review of some \25\ of the video and audio recordings made by an undercover agent (UC) named Luis Lopez capturing activity inside of American Pain.\26\ In those recordings, Burt observed who he believed to be an American Pain employee inside the facility standing up in a waiting room full of patients and directing them "not to have their prescriptions filled out of state, not to go out into the parking lot and snort their pills," and directing the patients to have their prescriptions filled "in house" (meaning at American Pain), at "a pharmacy they have in Orlando, Florida," or at "a pharmacy they have down the street," which, in Burt's view, was a reference to Boca Drugs. Id. at 825-26. Burt further testified that the purported employee on the recording told the patients to "obey all the traffic laws; do not give the police a reason to pull you over." Id. Although Burt testified as to the contents of these recordings, the physical recordings were not offered into evidence by the Government or made available to opposing counsel.
\26\ The fact that these recordings were made during the course of seven different office visits by an undercover agent to both the Boca Raton and Lake Worth locations was established on cross- examination. Tr. at 900, 985.
American Pain in October 2009.\27\ Burt stated that he was approached by an unnamed PBSO officer who advised that he had a confidential source "that could go into American Pain and purchase oxycodone from one of the doctors." Id. at 870. Burt met CS3 at a predesignated location, at which time the source was searched for contraband and provided with a recording device prior to entering American Pain to visit the Respondent, whom he had a scheduled appointment with and had previously been seen by at the clinic. Id. at 871, 877, 1050. At a subsequent debriefing, Burt testified that "the source told [him] that he went into the office with [the Respondent], put on the blood pressure cuff himself, took his own blood pressure, was given no physical exam by the doctor, and left with a prescription of oxycodone." Id. at 878. Burt testified that he was not able to simultaneously listen to the audio capturing the details of this office visit, and further admitted that has not reviewed the associated audio recording; instead, Burt's testimony was based on his review of a PBSO detective's written report and Burt's participation in the debriefing of CS3. Burt's testimony revealed that the investigative assistance of CS3 was secured as part of his cooperation with PBSO in relation to a pending criminal charge. Id. at 1047. Burt declined to disclose the name of CS3 when queried on cross-examination. Id. at 1045. The audio recording made by CS3 was not introduced by the Government into evidence or provided to opposing counsel.\28\ SA Burt was extremely vague and sketchy regarding the details of his encounter with CS3 relative to the Respondent. Id. at 870-82. In fact, without a refreshment of his recollection, Burt was not even sure that CS3 met with the Respondent, and not another American Pain physician with the same last name. Id. at 871-77. This portion of his testimony was received over the vociferous objections of Respondent, based on lack of relevance, unfair prejudice, and the inability for meaningful cross- examination based on a lack of access to either the recorded audio or even a witness who has heard the audio (or even knew the details of the visit), in conjunction with the absence of evidence of the name that would be on the patient chart reflecting the office visit. Tr. at 877- 82. Under the circumstances present here, including the tentative nature of his testimony as well as the manner in which it was produced, which, categorically denied the Respondent of any meaningful opportunity for the cross-examination required by the A.P.A.,\29\ this aspect of Burt's testimony may be accorded 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); see Tr. at 882.
\28\ Astonishingly, although SA Burt was offered by the Government as the proponent of all of the information relative to CS3, he conceded that he never listened to the audio tape created as a result of the wire worn by the informant. Tr. at 1051. According to Burt, the sum total of his awareness about the details regarding CS3 was gleaned from his presence at the post-encounter debriefing. Id.
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.\30\ Burt's record testimony indicates that DEA Task Force Officer \31\ (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.\32\ Likewise, the record evidence concerning SM did not implicate prescribing activity by the Respondent.
\30\ 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.
\31\ 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.
\32\ 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.\33\ 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.
The Government presented the bulk of its case through the report and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.\34\ Dr. Kennedy, who testified that he is board certified by the American Board of Pain Medicine and the American Board of Anesthesiology,\35\ was offered and accepted as an expert in the field of pain medicine. Id. at 39.
\34\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
concluded that the Respondent's physical examinations, treatment plans, and patient histories were below the standard fixed by the Florida Medical Board and that that controlled substances was not for a legitimate medical purpose. Id. at 585-88.
Dr. Kennedy prepared a report in connection with the Government's case against the Respondent, which is dated April 30, 2010, and was admitted into evidence. Govt. Ex. 101; Tr. at 585. The report describes a general analysis of sixteen charts that the Respondent maintained on as many patients, that were (selected by and) provided to Dr. Kennedy by the Government from among patient files seized pursuant to a criminal search warrant executed at the Respondent's practice on March 3, 2010 (Patient Charts Analysis). Although this report purports to describe practices common to all sixteen files reviewed by Dr. Kennedy, much of the analysis is directed toward a chart prepared in connection with JS,\36\ one of the Respondent's patients.
\36\ 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.
Dr. Kennedy's report makes it unambiguously clear that, in his opinion, all sixteen of the Respondent's charts that he reviewed suffered from the same shortcomings.\37\ The Patient Charts Analysis states that the Respondent's patient charts that Dr. Kennedy reviewed "are essentially the same with regard to review issues; as stated in the report of [JS] referenced and discussed in this report in detail, [and that] there were no significant differences that affected [his] conclusions and summary." Govt. Ex. 101 at 2.
\37\ 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.
\38\ Govt. Ex. 101 at 5.
\39\ Govt. Ex. 101 at 5. In Dr. Kennedy's opinion, the Respondent "prescribed, at the first visit, very high initial doses of controlled substance combinations despite not being within standard of care for histories, physical examinations and/or absent past medical records." Id. at 8.
\40\ Govt. Ex. 101 at 5.
\41\ Govt. Ex. 101 at 4. 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. at 4-5. \42\ Govt. Ex. 101 at 8. In Dr. Kennedy's opinion, Respondent "in effect, acted as a 'barrier' for [JS] to receive appropriate medical evaluation and treatment. In other words, the very potent, high doses of opioids (oxycodone) and benzodiazepine (Xanax) may have masked [JS'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 13.
\43\ Govt. Ex. 101 at 8.
\44\ Govt. Ex. 101 at 8.
\45\ Govt. Ex. 101 at 8.
\46\ Govt. Ex. 101 at 17. JS's chart did not contain any past medical records, save for a Lumbar report from an MRI performed the day before JS's first clinic visit to see the Respondent. Id. at 11.
\47\ Govt. Ex. 101 at 15.
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. 101 at 15. 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. Furthermore, the charts contained only rare evidence of contact with primary care physicians, treating physicians, pharmacists, or other health care providers. Id. at 15-16.
\48\ Govt. Ex. 101 at 17.
\49\ Govt. Ex. 101 at 15.
\50\ Govt. Ex. 101 at 10, 17.
\51\ Govt. Ex. 101 at 17.
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. 101 at 3, 17. Dr. Kennedy's report set forth his opinion 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 17. Significantly, however, when asked, Dr. Kennedy acknowledged that he conducts his own current medical practice on a cash-only basis. Tr. at 151.
\52\ 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.
A review of the sixteen patient files that informed the analysis, findings and conclusions offered in Dr. Kennedy's written report and testimony does reflect the presence of at least some of the red flag issues he identified therein, but there was not the unanimity among the files that he repeatedly urges. For instance, in terms of evidence related to therapeutic plans, it is notable that Respondent's patient files contain at least some indications of recommended treatment modalities in addition to the Respondent's exclusive use of controlled substances for pain management. There are notations in the charts reflecting a patient was to see a "PCP," or primary care physician, regarding jaundice, Govt. Ex. 108 at 9; in another patient file, a note listed under referrals reads "ER for eval of Cellulite + Possible IV ATBx." Govt. Ex. 109 at 1.
An examination of the reviewed patient charts does reveal the presence of other red flags that should have inspired additional diligence or inquiry on the part of the Respondent. RR's patient file, for example, contains a form indicating a positive UDS for oxycodone and benzodiazepine from 11/20/08, yet on the same date, the medication contract signed by RR is blank in that portion of the form designated for the patient to reveal any medications he or she is currently taking. Govt. Ex. 105 at 15, 31; see also Govt. Exs. 107 at 8-9, 21; 109 at 46, 54-55; 114 at 8-9, 20 (similar issues). Patient RS's file indicates a positive test for oxycodone on 9/10/09, yet on her medication contract sharing the same date, she crosses out her handwritten listings of Percocet and Xanax, and notes "*Sorry am not currently taking*." Govt. Ex. 110 at 10, 26. DS's patient file indicates a positive UDS for oxycodone and benzodiazepine only on January 14, 2010; however, the patient indicates elsewhere on a medical form filled out on the same date, in response to a question concerning whether she has taken any illegal or illicit drugs in the last 30 days, that she "smoked some marijuana because of [her] cancer." This disclosure notwithstanding, the lack of an indication of a positive "THC" result on the aforementioned UDS form is not addressed by the Respondent anywhere in the patient file. Govt. Ex. 112 at 10, 19. Patient JR's 7/17/09 UDS indicates a negative test for all listed substances, yet on two different forms dated 7/13/09 she indicates she is currently taking hydrocodone or Lortab, a discrepancy which raises questions about the validity of the testing procedures and/or the patient's candor. Govt. Exs. 106 at 12-13, 30; see also Govt. Ex. 113 at 11-12, 29 \53\ (similar issue). Patient CA's \54\ UDS form, on the other hand, lists a positive test result for oxycodone only on 11/3/09, yet the patient states she is also currently taking Xanax elsewhere on the medical forms from the same date. Govt. Ex. 103 at 10-11, 24; see also Govt. Ex. 116 at 17-18, 42 (same issue). 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. 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.
\53\ Although the disclosed date the medications were last prescribed could provide a plausible explanation for the discrepancy, this misses the point. These types of inconsistencies raise potential red flags that require a prudent registrant to make additional inquiry and document, at a minimum, how the issue has been resolved to the satisfaction of the registrant before controlled substance prescriptions are issued.
\54\ It is notable that patient "CA" is referred to using three different last names in the patient file records covering the period of time from 11/3/09 to 2/4/10, only one of which is present on her driver's license. See Govt. Ex. 103 at 1-2, 4, 8. This discrepancy is not addressed in any manner in the documentation.
patient RR's file contains a South Florida Pain Management Clinic physical examination form that was not filled out, and no physical examination form is present in the file reflecting such an exam was conducted by the Respondent. See Govt. Ex. 105 at 9-10.
Govt. Ex. 101 at 18.
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,\55\ 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. Id. 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.\56\ 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.
\56\ The Respondent did not testify on her own behalf.
\57\ This authority has been delegated pursuant to 28 CFR 0.100(b) and 0.104.
"[T]hese factors are considered in the disjunctive." Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of factors may be relied upon, and when exercising authority as an impartial adjudicator, the Deputy Administrator may properly give each factor whatever weight she deems appropriate in determining whether an application for a registration should be denied. JLB, Inc., d/b/a Boyd Drugs, 53 FR 43945 (1988); England Pharmacy, 52 FR 1674 (1987); see also David H. Gillis, M.D., 58 FR 37507, 37508 (1993); Joy's Ideas, 70 FR 33195, 33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989). Moreover, the Deputy 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 (D.C. Cir. 2005). The 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).
accept responsibility for [the established] misconduct, but also to demonstrate what corrective measures [have been] undertaken to prevent the reoccurrence of similar acts." Jeri Hassman, M.D., 75 FR 8194, 8236 (2010).
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 (D.C. 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.
he should be entrusted with a DEA certificate. In some cases, viewing a registrant's actions against a backdrop of how he has performed activity within the scope of the certificate can provide a contextual lens to assist in a fair adjudication of whether continued registration is in the public interest.
Regarding the Government's presentation, Agency precedent has long held that in DEA administrative proceedings that "the parameters of the hearing are determined by the prehearing statements." CBS Wholesale Distribs., 74 FR 36746, 36750 (2009) (citing Darrel Risner, D.M.D., 61 FR 728, 730 (1996); see also Roy E. Berkowitz, M.D., 74 FR 36758, 36759-60 (2009) ("pleadings in administrative proceedings are not judged by the standards applied to an indictment at common law" and "the rules governing DEA hearings do not require the formality of amending a show cause order to comply with the evidence"). That being said, however, the marked difference between the amount of evidence that the Government noticed in its OSC/ISO and the amount that it introduced at the hearing is striking. For example, contrary to its allegations, there was no evidence that the Respondent "prescribe[d] and dispense[d] inordinate amounts of controlled substances," that the "majority" of the Respondent's patients were "from states other than Florida," and there was no evidence that American Pain patients were issued "pre-signed prescriptions to obtain MRI[s]," nor was there evidence that individuals positioned outside the American Pain building were there to "monitor the activity of patients in the parking lot to prevent patients from selling their recently obtained controlled substances." Likewise, no evidence was introduced at the hearing that could support the allegations that "employees of American Pain  frequently ma[d]e announcements to patients in the clinic advising them on how to avoid being stopped by law enforcement upon departing the pain clinic" and "frequently ma[d]e announcements  advising [patients], among other things, not to attempt to fill their prescriptions at out-of state pharmacies and warning them against trying to fill their prescriptions at particular local retail pharmacies." ALJ Ex. 1 (emphasis supplied).
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing \58\ 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.
\58\ 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. Even apart from the unfortunate reality that one of the databases contained data that could not be directly tied to this Respondent as opposed to another with the same last name, 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 20th largest practitioner purchaser of oxycodone in the United States." \59\ 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, 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). 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.
\59\ ALJ Ex. 6 at 11-12.
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. at 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, was 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 specifically name the Respondent or any physician as being connected with his allegations of misconduct. Tr. at 853. 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.
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).
Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II- V * * * to a person for the treatment of intractable pain,\66\ provided the physician does so in accordance with that level of care, skill, and treatment recognized by a reasonably prudent physician under similar conditions and circumstances.
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.
physician's prescribing practices are "within the usual course of professional practice." Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert opinion presented \70\ in 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 his 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).
\70\ Respondent, in his brief, correctly points out that (for reasons not readily apparent) the Government elicited no testimony from Dr. Kennedy regarding any patient treated by the Respondent. Respt's Br. at 10-11.
In his Post-Hearing Brief (Respondent's Brief), the Respondent's counsel has prepared and submitted a thoughtful and detailed review of one of the patient charts that was analyzed by Dr. Kennedy in his report. Respt's Br. at 22-26. While counsel argues that the patient chart entries were, at least by his interpretation of his client's obligations, satisfactory, the expert's opinion at the hearing remained unchanged. Even acknowledging, as this recommended decision does, that Dr. Kennedy's presentation was not without its deficiencies, its shortcomings do render it so fundamentally defective as to completely undermine his credibility and viability as within the scope of what a litigant may depend upon.\71\ As recognized in the Respondent's Brief, "the [G]overnment, like any party in a contested hearing, is free to hire an expert to advocate its position." Respt's Br. at 12. Unfortunately, counsel's analysis of the patient chart prepared by the Respondent 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.
\71\ Likewise, contrary to the position taken by the Respondent in his brief (Respt's Br. at 7), Dr. Kennedy's opinions are not invalidated by the size of the representative sample of files he reviewed or the manner in which they were selected. Firstly, SA Langston provided credible testimony regarding the selection process, which although admittedly not a paradigm of scientific sampling methodology, was likewise not designed to achieve a particular result. Secondly, contrary to the assertion in the Respondent's brief (Respt's Br. at 15), there is no baseline magic number of files or registrant actions that must be examined to support an expert opinion and ultimately an Agency determination as to whether a registrant has committed acts inconsistent with the public interest sufficient to merit adverse action relative to a DEA COR. See Krishna-Iyer, 74 FR at 464.
Deputy Administrator is authorized to consider "other conduct which may threaten the public health and safety." 21 U.S.C. 823(f)(5). Although this factor authorizes consideration of a somewhat broader range of conduct reaching beyond those activities typically associated with a registrant's practice, an adverse finding under this factor requires some showing that the relevant conduct actually constituted a threat to public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
The evidence establishes that the Respondent engaged in a course of practice wherein he prescribed 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.

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