Source: https://www.deadiversion.usdoj.gov/fed_regs/actions/2011/fr0407.htm
Timestamp: 2019-04-25 16:01:13+00:00

Document:
Having reviewed the entire record including the ALJ's recommended decision and Respondent's exceptions, 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 21. While there is no evidence as to the amounts Respondent may have dispensed directly, there is such evidence, which is unrefuted, with respect to his prescriptions. As explained in my discussion of Respondent's Exceptions, an Expert witness testified as to the usual starting doses of oxycodone and Xanax and that the prescriptions Respondent issued for both drugs, even at the initial visit, greatly exceeded the usual starting doses and lacked a legitimate medical purpose. 21 CFR 1306.04(a). Moreover, there is also unrefuted evidence that Respondent's prescribing of drug cocktails of oxycodone and Xanax lacked a legitimate medical purpose. I thus reject the ALJ's finding to the extent that it states that there was no evidence that Respondent prescribed 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 Dec. at 20-21. 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 FR49956, 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 conclusion 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 33 (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 34 (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" is clearly supported by substantial evidence and warrants an adverse finding under factor five. ALJ at 34.
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 29 (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 is necessarily dependent 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.
Respondent first takes exception to the ALJ's acceptance of L. Douglas Kennedy, M.D., as an expert on the proper prescribing of controlled substances. Respondent contends that Dr. Kennedy should not have been permitted to opine on his prescribing practices because he does not hold a DEA registration in Florida, has not prescribed a controlled substance since 2004, does not currently have either a medical office or hospital privileges in Florida, and "has never practiced medicine regularly in Florida and has not practiced medicine in Florida at all in over 10 years." Resp. Exc. at 1.
Respondent's contention is unavailing as Dr. Kennedy was clearly qualified to render an expert opinion on the proper practice for prescribing controlled substances to treat pain and whether Respondent's controlled substance prescriptions were issued in the usual course of professional practice and for a legitimate medical purpose. See 21 CFR 1306.04(a). Dr. Kennedy currently holds a Florida medical license, is a diplomate of both the American Board of Pain Medicine and the American Board of Anesthesiology, and is currently on the faculty of the University of Miami's Miller School of Medicine. GX 117, at 1, 10. Previously, Dr. Kennedy was a Fellow with the Pain Therapy Unit of the Cleveland Clinic, served as the Director of Chronic Pain Management at the University of Kentucky Medical Center, and, for fourteen years, was the Medical Director of a multidisciplinary pain medicine and rehabilitation practice. Id. at 1-2.
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 76, at 5-6.
\4\ He also co-edited and contributed to the State of Kentucky's Guidelines for Prescribing Controlled Substances, 2nd Edition. GX 117, at 9.
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.
Next, Respondent contends that Dr. Kennedy's opinion testimony is entitled to no weight because it was based on only seventeen 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. Based on Dr. Kennedy's testimony that "'[i]t might not be fair'" to "'cherry-pick'" a small and non-random sample of charts out of a physician's patients because this might not provide "'a reasonable representation of what the practice was actually like,'" Respondent argues that "[e]ven improper prescribing practices reflected in a small and non-random sample of 17 charts * * * may 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. 645).
However, even acknowledging that two of the seventeen files reviewed by Dr. Kennedy with respect to Respondent were not randomly selected (one being 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), the Government is not required to randomly select the files which it will base its case on.
though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation. See Paul Caragine, 63 FR 51592 (1998) (granting restricted registration where practitioner did not engage in intentional misconduct, patients had legitimate medical conditions requiring treatment, and practitioner accepted responsibility and testified as to remedial measures he had undertaken). See also Dewey C. MacKay, 75 FR at 49977 (revoking registration based on intentional acts of diversion to two patients); 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; Alan H. Olefsky, 57 FR 928, 929 (1992) (revoking registration based on physician's single act of presenting two fraudulent prescriptions to pharmacist where physician failed to acknowledge wrongdoing).\5\ Accordingly, there is no merit to Respondent's exception.
\5\ Consistent with DEA's longstanding precedent, see ALJ at 17, 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.
Finally, Respondent takes exception to the ALJ's findings that he violated Florida's standards for prescribing controlled substances. Resp. Exceptions at 4-5. More specifically, Respondent contends that he complied with the standards set forth under Florida regulations and that he "took a complete medical history and conducted a physical evaluation that was documented," that he maintained "medical records documenting the patient's intensity of pain, current and past treatments for pain, and the effect of pain on physical and psychological function." Id. at 4-5. 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 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 15, 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.\6\ See GX 76, at 5-6.
\6\ Even after Gonzales v. Oregon, 546 U.S. 243 (2006), several 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 * * * ."). To similar effect, 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)).
In any event, Respondent produced no 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.
As Dr. Kennedy explained, the patients whose files he reviewed were relatively young (with an average age of 36), and most were from out- of-state, with some travelling up to 1200 miles,\7\ even though Respondent had no specialized training in pain management. Id. at 15- 16. Yet, Respondent did not obtain reports from the prescription monitoring programs run by the States where his patients lived. Id. at 1-2; 14. 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 4, 8-9.
\7\ Of the seventeen patients, only four were from Florida. Of the remaining patients, five were from Kentucky, three were from Ohio, two were from Tennessee and West Virginia, and one was from Georgia. GX 76, at 1.
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 15. 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 his patients' medical records "was well outside the boundaries of medical practice and below the standard of medical care," especially because the patients were 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 14-15.
\8\ Dr. Kennedy explained that referring a patient to obtain an MRI prior to having some contact is unusual and medically inappropriate. Tr. 71-73.
Moreover, notwithstanding the doses the patients were seeking, Respondent rarely referred a patient to another physician or health care professional for a consultation.\9\ As Dr. Kennedy explained, "[a]lternative 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. at 14. 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 15.
\9\ In only two of the seventeen files is there an indication that Respondent referred the patient to another physician.
Dr. Kennedy also 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. See id. at 11, 14. Moreover, the drug screens were rarely performed other than at the patient's initial visit and lacked quality controls.\10\ Id. at 14.
\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 76, at 14; Tr. 100-01.
their primary care physicians because they had high blood pressure, see GXs 78, 79; he never referred any patients for consultations with specialists, or for physical, occupational, or mental health therapy. GX 76, at 11.
Dr. Kennedy noted that Respondent frequently prescribed "drug cocktails" of two strengths of oxycodone immediate release and a high dose of Xanax, a benzodiazepine. Id. at 4, 9, 13. 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 M.B., 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 9.
Dr. Kennedy further noted 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., twice per day, to fifteen of the seventeen patients (including M.B.); another patient B.R. (GX 87) received Xanax 2 mg. once per day.\11\ Id. at 9-10; GXs 78-86, 88-93. Moreover, Respondent prescribed this dose even for patients who had not been on the drug either before or recently and "no matter the [patient's] age or clinical situation." GX 76, at 10. While Xanax is used as an anti- anxiety agent, Respondent's medical records did not support the prescribing because "[h]e did not list * * * many important factors that could cause anxiety * * * such as depression, life stressors, psychosocial situation, caffeine intake, sleep disturbance [and] previous medical evaluation;" he also did not refer these patients for evaluation by a mental health professional. Id. With respect to M.B., Dr. Kennedy observed not only that "there was no specific reason stated in the medical record" for prescribing Xanax, but also that Respondent's prescribing of a very high dose of the drug "was clearly not within the boundaries of professional practice." Id. at 9-10.
\11\ The remaining patient, L.A., received Valium 10 mg. GX 77.
Dr. Kennedy further noted that beginning with M.B.'s first visit, Respondent "prescribed very high initial and subsequent high doses of oxycodone and Xanax" and that these drugs "were prescribed excessively and inappropriately without medical justification." Id. at 9. Sections of the history and physical examination form "were grossly incomplete or missing entirely," and Respondent did not identify "past treating and prescribing physicians" and communicate them regarding M.B.'s previous treatment (and obtain medical records) even though M.B. had indicated that he had previously seen a doctor and had physical therapy for his condition. Id. at 9; GX 78, at 16.
While M.B. apparently told Respondent that he was taking 210 to 240 oxycodone 30 mg. per month, which he had obtained "off the street," and he also tested positive for the drug in a urine drug screen (UDS) done at his initial visit, Respondent prescribed 180 Roxicodone 30 mg., 60 Roxicodone 15 mg., and 60 Xanax 2 mg. to M.B. at each of the seven visits he made between August 20, 2009 and February 4, 2010. GX 78, at 7, 9, 13, 18-24.
M.B.'s statement that he was getting "large quantities of oxycodone 30 mg. pills 'off the street"' was a clear "warning sign" that he was "at high risk for drug abuse, addiction and/or diversion." GX 76, at 12; see also id. at 8. Yet, as Dr. Kennedy observed, Respondent "did not appropriately act on the initial UDS" and M.B.'s admission that he had obtained drugs off the street by requiring him to undergo "[f]urther testing." Id. at 11. Indeed, "[t]here were no other UDS tests obtained [after the initial visit] nor other toxicology testing." Id. Dr. Kennedy further noted that Respondent "did not obtain any pharmacy drug profiles [from] where [M.B.] had his prescriptions filled," his chart did not indicate where he was filling his prescriptions, and he did not obtain prescription monitoring reports from States where M.B. may have filled prescriptions. Id. He also did not obtain prescription monitoring reports for any of the other sixteen patients. Id.
Finally, Dr. Kennedy explained that the "drug cocktails" Respondent prescribed of "very potent, high doses" of oxycodone and Xanax (or Valium), id. at 11, are "attractive to 'patients' who abuse, are addicted and/or divert (sell or trade) their prescribed controlled substances. They might take them all together to achieve a 'high,' sell some for cash, or trade some for other drugs they prefer." Id. at 9. Dr. Kennedy also noted that "[w]hen opioids and benzodiazepines are used in combination, the potential for [a] drug overdose and death is increased," and "[t]he risk of abuse, addiction and/or diversion is also significantly increased." Id. at 7. As Dr. Kennedy observed, "[t]hese 'drug cocktails' were clearly not for any legitimate medical purpose." Id. at 13.
As Dr. Kennedy concluded, Respondent "was not engaged in the practice of medicine," and "[t]he vast majority of his prescriptions for controlled substances w[as] 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 therefore reject this exception as well.
I therefore 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. at 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, AD7585865, issued to Jacobo Dreszer, M.D., be, and it hereby is, revoked. I further order that any pending application of Jacobo Dreszer, M.D., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.
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 \12\ 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.\13\ The immediate suspension of the Respondent's COR has remained in effect throughout these proceedings.
\12\ Although the Respondent's COR expired on July 31, 2010, the parties stipulated that a timely renewal application has been submitted by the Respondent. ALJ Ex. 31.
\13\ Pursuant to an order issued on April 15, 2010, with the consent of the Respondent, ALJ Ex. 9, 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 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,\14\ 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 \15\ 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. 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. Lastly, in its Prehearing Statement, the Government further alleges that one of the Respondent's patients died from an overdose of oxycodone and alprazolam \16\ one day after obtaining prescriptions for those same controlled substances from a visit to the Respondent at American Pain. Id.
\14\ A schedule II controlled substance.
\15\ The majority of which are supported by no evidence introduced by the Government during the course of these proceedings.
\16\ A schedule IV controlled substance.
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.\17\ 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 one of the other co-Respondents (his son), the document is of no utility in reaching a disposition of the present case.
\17\ 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 \18\ or OUTSIDE the STATE OF FLORIDA.
\18\ 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.
Id. The final attachment to the composite sign bears the words "24 Hour Camera Surveillance." Id. A photograph of the composite sign was admitted into evidence.
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.\19\ Govt. Ex. 119 at 2.
\19\ 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.
investigators reviewed the seized files with a view towards choosing approximately fifteen files for each doctor with the aspirational criteria that each would reflect at least three to four visits by that doctor with a patient. Each investigator was empowered to place a chart on the selected pile, and when the target number (or about that number) was reached for each physician, the selection effort relative to that physician was deemed accomplished. Id. at 765. Langston credibly testified that there was no effort to specially select files under some prosecution-enhancement or "cherry picking" purpose. Id. at 768.
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. 71.
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. 72-74. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 229 controlled substance prescriptions issued over the Respondent's signature to seventy-three patients located in West Virginia, 135 similar prescriptions provided to fifty-three Kentucky-based patients were filled between January 1, 2009 and April 4, 2010, and 144 such prescriptions pertaining to sixty-three patients located in Ohio were filled between April 1, 2008 and April 19, 2010. Id.
\20\ 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.
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 \21\ 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 6:00 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.
\21\ 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 user name 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 \22\ 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) \23\ 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" \24\ for these office visits, and the six doctors at the clinic saw "anywhere from 200 upward to 375 patients a day" \25\ in this manner.\26\ Id. at 882-83 (emphasis supplied).
\23\ 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.
\24\ Later on cross-examination, SA Burt admitted that the clinic also accepted payment via credit card. Tr. at 916.
\25\ 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.
\26\ 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 \27\ of the video and audio recordings made by an undercover agent (UC) who assumed the name Luis Lopez, capturing activity inside of American Pain.\28\ 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.
\28\ 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.
managed." Id. at 827-28. These concerns included medical records being, in his opinion, annotated inadequately by the doctors, and what he perceived as a lack of supervision during patient urinalysis testing, where patients would "go to the bathrooms together, bringing items with them to the bathrooms that could possibly disguise the urinalysis." According to Burt, Sollie explained that he perceived that patients were substituting urine produced by other persons that contained the metabolites 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.
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.\29\ Burt's record testimony indicates that DEA Task Force Officer \30\ (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.\31\ Likewise, the record evidence concerning SM did not implicate prescribing activity by the Respondent.
\29\ 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.
\30\ 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.
\31\ 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.\32\ 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.\33\ Dr. Kennedy, who testified that he is board certified by the American Board of Pain Medicine and the American Board of Anesthesiology,\34\ was offered and accepted as an expert in the field of pain medicine. Id. at 39.
\33\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
Dr. Kennedy testified that after a review of a group of selected patient files from those seized at the Respondent's practice that were to him provided by the Government, he 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 579-82.
Dr. Kennedy 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 input. That being said, Dr. Kennedy highlighted numerous features in the Respondent's chart documentation that he found wanting, or at least remarkable.
Dr. Kennedy also 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. 76; Tr. at 579. The report describes a general analysis of seventeen 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 seventeen files reviewed by Dr. Kennedy, much of the analysis is directed toward a chart prepared in connection with MB,\35\ one of the Respondent's patients.
\35\ 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.
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 [MB] referenced and discussed in this report in detail, [and that] there were no significant differences that affected [his] conclusions and summary." Govt. Ex. 76 at 2.
\36\ 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.
\37\ Govt. Ex. 76 at 4.
\38\ Govt. Ex. 76 at 4. In Dr. Kennedy's opinion, the Respondent "prescribed, at the first visit, very high initial doses of controlled substance combinations despite not being within the standard of care for histories, physical examinations and/or absent past medical records." Id. at 7.
\39\ Govt. Ex. 76 at 4.
\40\ Govt. Ex. 76 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 3-4. 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.
\41\ Govt. Ex. 76 at 7. In Dr. Kennedy's opinion, Respondent in effect, acted as a 'barrier' for [MB] 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 [MB's] underlying disease process(s), making them more difficult to diagnose, and allowing the disease(s) to unnecessarily worsen. Without an accurate diagnosis and no plan to obtain one, [the Respondent] was masking the symptoms. Id. at 10-11.
\42\ Govt. Ex. 76 at 7.
\43\ Govt. Ex. 76 at 7.
\44\ Govt. Ex. 76 at 7.
\45\ Govt. Ex. 76 at 15. MB's chart did not contain any past medical records, save for a Lumbar report from an MRI performed six weeks before MB's first clinic visit to see the Respondent. Id. at 8.
\46\ Govt. Ex. 76 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. 76 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. For instance, Dr. Kennedy notes that MB's patient file contains a notation about the patient getting Roxicodone "off the street," along with an initial positive urinalysis screen for oxycodone, yet the Respondent continued to prescribe MB with additional Roxicodone during his initial and subsequent visits. Id. at 8-9, 11; see also Govt. Ex. 87 at 4, 9; 90 at 3, 9; 91 at 4, 8; 93 at 5, 10 (similar notations involving other patient's acquiring controlled substances "off the street"). 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.
\47\ Govt. Ex. 76 at 16.
\48\ Govt. Ex. 76 at 13.
\49\ Govt. Ex. 76 at 8, 15.
\50\ Govt. Ex. 76 at 16.
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. 76 at 3, 16. 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 16. Significantly, however, when asked, Dr. Kennedy acknowledged that he conducts his own current medical practice on a cash-only basis. Tr. at 151.
controlled substances for pain management. For example, Respondent included notations in the records of referring patients to see a "PCP," or primary care physician, for elevated blood pressure. Govt. Exs. 78 at 1-3, 6; 79 at 1. Furthermore, some of the patient history and physical exam forms contain some effort in documenting medication efficacy. Govt. Exs. 83 at 7; 92 at 2.
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. LA's patient file, for example, contains a form indicating a positive UDS for oxycodone and benzodiazepine from 5/18[/09], yet on the same date, the medication contract signed by LA is blank in the section where a patient is supposed to list any medications they are currently taking; likewise, the similarly worded section on the "Patient Comfort Assessment Guide" form also has no medications listed. Govt. Ex. 77 at 12-13, 30; see also Govt. Exs. 78 at 13-14, 32; 86 at 14-15, 30; 89 at 8-9, 22 (similar issues). CR's patient file, on the other hand, indicates a positive UDS for "THC" in addition to benzodiazepine and hydrocodone, yet the patient does not disclose marijuana as a "medication" he is currently taking on any of the relevant forms, and, in fact, this positive test is not addressed by the Respondent in any discernible manner in the chart. Govt. Ex. 79 at 9. Patient KL's 7/17/09 UDS indicates a negative test for all listed substances, yet on two different forms dated 7/13/09 he indicates he is currently taking two strengths of oxycodone along with Xanax. Govt. Ex. 82 at 13-14, 31. The UDS form in patient GE's file reflects circled positive results for benzodiazepines, opiates, and oxycodone. This is noteworthy in that the currently-taking list of medications includes seven other drugs, but not these three. Govt. Ex. 80 at 9, 24-25. Patient BR's UDS form, on the other hand, lists a positive test result for oxycodone only on July 24, 2009, yet the patient states she is also currently taking Xanax elsewhere on the medical forms from the same date. Govt. Ex. 88 at 11- 12, 25; see also Govt. Exs. 90 at 9-10, 22; 92 at 8-9; 93 at 5, 10-11, 26 (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.
In addition to the lack of adequately completed forms in some patient files noted by Dr. Kennedy, other patient files appear to be missing key documentation altogether. See Govt. Ex. 92 (no pain management agreement, medication contract, or diversion policy present).
Govt. Ex. 76 at 16.
On cross examination, Dr. Kennedy agreed that he assumed, for the purposes of his analysis, that where the Respondent's charts reflected an entry or a procedure, that the event actually occurred. Tr. at 654. Kennedy also acknowledged that every one of the patient files he reviewed contained at least a complaint of chronic pain symptoms by the patient and MRI results that could support such a diagnosis. Id. at 655-57.
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,\51\ 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.\52\ 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.
\52\ The Respondent did not testify on her own behalf.
\53\ This authority has been delegated pursuant to 28 CFR 0.100(b) and 0.104.
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported, Morall, 412 F.3d at 183, but mere unevenness in application does not, standing alone, render a particular discretionary action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (DC Cir. 2008) (citing Butz v. Glover Livestock Comm. Co., Inc., 411 U.S. 182, 188 (1973)), cert. denied, -- U.S. --, 129 S.Ct. 1033 (2009). It is well- settled that since the Administrative Law Judge has had the opportunity to observe the demeanor and conduct of hearing witnesses, the factual findings set forth in this recommended decision are entitled to significant deference, Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951), and that this recommended decision constitutes an important part of the record that must be considered in the Deputy Administrator's decision, Morall, 412 F.3d at 179. However, any recommendations set forth herein regarding the exercise of discretion are by no means binding on the Deputy Administrator and do not limit the exercise of that discretion. 5 U.S.C. 557(b); River Forest Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the Administrative Procedure Act 8 (1947).
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.
In this case, the gravamen of the allegations in the OSC/ISO, as well as the factual concentration of much of the evidence presented, share as a principal focus the manner in which the Respondent has managed that part of his practice relative to prescribing and dispensing controlled substances and acts allegedly committed in connection with his practice at American Pain. Thus, it is analytically logical to consider public interest factors two, four and five together. That being said, factors two, four and five involve analysis of common and distinct considerations.
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 \54\ 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.
\54\ 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 8th largest practitioner purchaser of oxycodone in the United States."\55\ 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.
\55\ 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,\56\ or advising them to comply with vehicle and traffic laws,\57\ 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.
apparently never explained to Burt,\58\ 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.
The Government's evidence targeted not only the Respondent's experience practicing under Factor 2, but also his compliance with applicable state and federal laws relating to controlled substances under Factor 4. To effectuate the dual goals of conquering drug abuse and controlling both legitimate and 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,\59\ which the CSA defines as "to deliver a controlled substance to an ultimate user \60\ * * * 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).
\60\ "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).
\61\ 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).
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,\62\ 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.
Fla. Stat. Sec. 458.326 (2009). Moreover, the Florida Board has adopted,\63\ 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 tenets 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.
\62\ 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).
\63\ 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," \64\ resort must be had to an expert.
The Florida Standards direct that "[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes," id. at 9.013(1)(d), and provide that the prescribing of controlled substances for pain will be considered to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law.
Id. at 9.013(3)(f). The same section directs that "[r]ecords must remain current and be maintained in an acceptable manner and readily available for review." Id.
A complete \65\ 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.
\65\ 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.
depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment." (emphasis supplied). Id.
3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement).
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 opinion presented \66\ 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 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).
\66\ 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 not render it so fundamentally defective as to completely undermine his credibility and viability as within the scope of what a litigant may depend upon.\67\ 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 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.
\67\ 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.
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.
Accordingly, after carefully balancing the admitted evidence, the evidence establishes, by a preponderance, that the prescriptions the Respondent issued in Florida were not issued within "the usual course of [the Respondent's] professional practice." 21 CFR 1306.04(a). Consideration of the evidence under the second and fourth factors support the COR revocation sought by the Government in this case.

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