80 FR 53191 - Abbas E. Sina, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 170 (September 2, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 170 (September 2, 2015)
| Page Range | 53191-53203 | |
| FR Document | 2015-21732 |
[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)] [Notices] [Pages 53191-53203] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21732] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 14-6] Abbas E. Sina, M.D.; Decision and Order On May 15, 2015, the then-Administrator of the Drug Enforcement Administration issued the attached order. Therein, based on her review of the record, the then-Administrator concluded that, in the event Respondent presented evidence that he has continued to comply with his Professionals Resource Network (PRN) contract and has passed all drug tests since the closing of the record, he is entitled to be registered subject to the extensive conditions set forth in her order. The then- Administrator thus ordered Respondent to provide such evidence. In response to the order, Respondent provided his drug test results, all of which have been negative. Respondent did not, however, provide evidence of his compliance with the other terms of his PRN contract. Accordingly, on July 27, 2015, I issued an order directing Respondent to ``provide a sworn letter from the PRN attesting to his continued compliance with his PRN contract.'' Order of the Administrator, at 1 (July 27, 2015). Respondent has now complied and submitted a notarized letter from Penelope P. Ziegler, M.D., the PRN's Medical Director, attesting that he has remained fully compliant with his PRN contract. I therefore conclude that Respondent has met the requirements for obtaining a new registration as set [[Page 53192]] forth in the May 15, 2015 order (which is attached and incorporated as the Decision in this matter), and that he is entitled to be registered subject to the conditions set forth therein. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Abbas E. Sina, M.D., for a DEA Certificate of Registration as a practitioner be, and it hereby is, granted, subject to the conditions set forth in the then- Administrator's Order of May 15, 2015. This Order is effective immediately. Dated: August 26, 2015. Chuck Rosenberg, Acting Administrator. Anthony Yim, Esq., for the Government. William W. Tison, III, Esq., for the Respondent. ORDER OF THE ADMINISTRATOR May 15, 2015 On November 12, 2013, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Abbas E. Sina, M.D. (hereinafter, Respondent), of St. Pete Beach, Florida. ALJ Ex. 1, at 1. The Show Cause Order proposed the denial of Respondent's application for a DEA Certificate of Registration as a practitioner, on the ground that his ``registration would be inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id. As jurisdictional facts, the Show Cause Order alleged that Respondent had previously held a DEA Certificate of Registration which he surrendered ``for cause on July 13, 2011,'' id. at 2, and that on July 13, 2012, he had applied for a new practitioner's registration seeking authority to dispense controlled substances in schedules II through V. Id. at 1. The Order then alleged that during an interview with a DEA Investigator regarding his application, Respondent admitted to a history of abusing controlled substances including heroin. Id. More specifically, the Show Cause Order alleged that Respondent admitted that ``[o]n or about February 26, 2003,'' he had ``purchased heroin from street dealers'' and ``overdosed,'' after which he was arrested and charged with possessing heroin, possessing drug paraphernalia, and driving under the influence. Id. The Order then alleged that Respondent was allowed to resolve the charges by entering a pre-trial diversion program, but that in 2004, he had again begun to abuse controlled substances. Id. at 1-2. Next, the Show Cause Order alleged that between June 19, 2004 and March 23, 2005, Respondent had written eleven prescriptions for OxyContin 80mg, which authorized the dispensing of 720 dosage units, ``without establishing a valid doctor-patient relationship,'' and that ``a medical expert who reviewed [his] actions concluded that [the] prescriptions . . . were for other than a legitimate medical purpose and outside the usual course of professional practice.'' Id. at 2 (citing 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a)). The Order further alleged that the Florida Board of Medicine had instituted a proceeding against him based on his misconduct but that he had been ``allowed to settle the case without admitting to the underlying allegations.'' Id. The Show Cause Order further alleged that during his September 2012 interview, Respondent admitted that he had again begun ``abusing heroin in late 2009/early2010,'' and that his use of heroin had tripled over the course of several months. Id. The Order then alleged that during the interview, Respondent admitted that ``on or about February 4, 2011,'' he had been arrested at Tampa International Airport and charged with possession of heroin with intent to distribute; possession of methadone, a schedule II drug; possession of Xanax, a schedule IV drug; possession of drug paraphernalia; and trafficking in illegal drugs. Id. The Order also alleged that Respondent was allowed to resolve the charges by entering a pre-trial diversion program. Id. Respondent timely requested a hearing on the allegations. ALJ Exs. 2 & 3. The matter was placed on the docket of the Office of Administrative Law Judges, and assigned to Administrative Law Judge (ALJ) McNeil who, following pre-hearing procedures, conducted an evidentiary hearing in Clearwater, Florida on March 4-5, 2014. Following the hearing, both parties filed briefs containing their proposed findings of fact, conclusions of law, and recommended order. On May 7, 2014, the ALJ issued his Recommended Decision. Therein, the ALJ found that the Government had established a prima facie case to deny Respondent's application. With respect to Factor Two--Respondent's experience in dispensing controlled substances--the ALJ noted that Respondent had ``significant positive training and credentials relating to prescribing controlled substances,'' which included his training as a medical resident, his twenty-three years as an emergency room physician, his completion of a course in the proper prescribing of controlled substances, and his studying to become board certified in addiction medicine. R.D. at 36-37. However, the ALJ further explained that ``while he was buying heroin and other drugs on the street, [Respondent] has become very well acquainted with those in the community who have chosen to traffic in heroin'' and that ``[a] person with that kind of experience, particularly one authorized to write prescriptions for narcotics and other controlled substances, holds a highly valuable key recognized by those in our society who are likely to try to exploit that authority to advance their own illicit goals.'' Id. at 37. Continuing, the ALJ reasoned that restoring Respondent's ``ability to prescribe controlled substances carries with it some risk, given the unique skill set [he] developed while seeking heroin and other drugs on the street.'' Id. at 38. The ALJ then reasoned that while Respondent ``may well be able to resist efforts from those in the trafficking trade to recruit him during periods of sustained stable recovery, were he to relapse those illicit efforts may well prove successful, creating a significant risk of prescription drug diversion.'' Id. The ALJ thus concluded that ``Factor Two neither supports nor contradicts granting [his] application.'' Id. As for Factor Four--compliance with applicable laws related to controlled substances--the ALJ noted that Respondent had conceded that the Government had established a prima facie case to deny his application. Id. The ALJ then noted that Respondent had unlawfully possessed heroin and drug paraphernalia in 2003; that he had unlawfully prescribed 720 dosage units of OxyContin to his girlfriend, which he then diverted for his own use; that he had misled state authorities ``by withholding from them the fact that he was diverting the [drugs] for his own use''; and that in 2011, he unlawfully possessed heroin, methadone, and Xanax, as well as drug paraphernalia. Id. at 39. The ALJ thus concluded that the evidence with respect to Factor Four provided ``a legally sufficient basis'' to deny his application. Id. As for Factor Five--such other conduct which may threaten public health and safety--the ALJ noted that Respondent's self-abuse of controlled substances itself supports denying his application. Id. at 40. The ALJ further noted that independent of the evidence of his abuse of controlled substances, the evidence showed that during his periods of abuse, he ``has a demonstrated tendency towards lying in the course of responding to governmental processes.'' Id. The ALJ [[Page 53193]] also suggested that Respondent had given false testimony in this proceeding when he testified that the report of a physician, who had reviewed the investigative file prepared by a Florida DOH investigator for the DOH, was ``100 percent accurate'' because it ``made no mention of the whole truth,'' that being that Respondent was diverting the drugs for his own use. Id. However, the ALJ then noted that Respondent does not currently present[ ] a threat to the public due to a predisposition to prevaricate'' and that he ``can be relied upon to be forthright and candid during his recovery.'' Id. at 41. The ALJ further noted that he ``was impressed with [Respondent's] demeanor, his expressions of regret and apology, and with his determination to succeed in his recovery.'' Id. The ALJ nonetheless concluded that Respondent's ``chronic history of substance abuse'' and ``pattern of misleading governmental officials'' created ``an unacceptably strong likelihood that [he] would revert to his past behavior and would attempt to either self-medicate or self-destruct'' and thus provided a ``legally sufficient and independent basis'' to deny his application. Id. Addressing the evidence of remediation, the ALJ found that the record as a whole supported the conclusion that Respondent has accepted responsibility for his misconduct. Id. at 42. However, based on the testimony of two of Respondent's witnesses, the ALJ concluded that Respondent's ``risk of relapse remains high, and will continue to be high . . . throughout the five years following the commencement of his recovery'' and ``that insufficient time in stable recovery has passed to support a finding that corrective action has been taken.'' Id. While acknowledging that ``steps that may lead to effective corrective action have begun, . . . those steps are not complete, and in the absence of complete corrective action the Respondent has not, by a preponderance, presented evidence that would permit the restoration of his'' registration. Id. at 42-43. The ALJ thus recommended that Respondent's application be denied. Thereafter, the parties filed a Joint Statement Regarding the Proposed Stipulations. However, only the Government filed Exceptions to the Recommended Decision. As for the Joint Statement Regarding the Proposed Stipulations, therein, the parties averred that ``it was their impression and understanding that'' they had agreed only to the Government's Proposed Stipulations numbers one (1) through eight (8) (apparently as set forth in the Supplemental Prehearing Statement) and Respondent's Proposed Stipulations one (1) through four (4). The parties further stated that they did not agree to Respondent's Proposed Stipulations five (5) through twenty-four (24). Thereafter, the record was forwarded to this Office for final agency action. Having considered the entire record, I agree with the ALJ's conclusion that the Government has satisfied its prima facie burden of showing that Respondent's registration would be inconsistent with the public interest. R.D. 49. However, in the event Respondent has continued to remain in compliance with his PRN contract and has passed all of his drug tests since January 28, 2014 and produces such evidence within thirty (30) days of the date of this Order, I conclude that he will have produced sufficient evidence to rebut the Government's prima facie case. Id. at 50. I make the following findings.\1\ --------------------------------------------------------------------------- \1\ Because the parties jointly agree that the Government never agreed to Respondent's proposed stipulations numbers five (5) through twenty-four (24), I do not consider those stipulations as proving their factual assertions. However, having read the relevant portion of the transcript, I do not find the Government's argument well taken, and but for the fact that Respondent agreed that the Government had not agreed to the stipulations, I would have rejected the Government's contention. According to the transcript, the following colloquy occurred: ALJ: Okay. All those stipulations are now considered as facts that I will use in the analysis and recommendations that I prepare in this case. ALJ: [Government Counsel], the Government was able to stipulate to the four facts shown in my order of January 28, 2014, but it was not able to stipulate to the remainder of those stipulations proposed by the Respondent. Those appear in the Respondent's initial prehearing statement. Do you have that statement? [Government Counsel]: I do your honor. ALJ: Are there any proposed stipulations there for which the Government cannot agree? Government Counsel: No, your honor. Tr. 45-46. The Government contends that the ALJ ``erred'' in ``interpret[ing] this colloquy as the Government's agreement to stipulate to the nineteen stipulations to which it had previously declined to agree in writing.'' Gov. Exceptions, at 5. This argument, however, begs the question of why the ALJ would ask the Government if it was stipulating to the same four stipulations which it had already agreed to during the conference held by the ALJ on January 28, 2014. See Tr. 13. (ALJ: ``Are there any of those that you agree can be considered as fact?'' Government Counsel: ``Stipulations 1 through 4, your honor.'' ALJ: ``1 through 4 are admitted as evidence without further evidence being required to establish those as fact then.''). I find that the ALJ's question was clear enough to put the Government on notice that he was asking about those stipulations offered by Respondent which the Government had not previously agreed to. To extent the Government was unclear as to which stipulations the ALJ was asking it about, it was incumbent on the Government to clarify which stipulations it had agreed to. --------------------------------------------------------------------------- FINDINGS OF FACT Respondent's Licensure and Registration Status Respondent is a medical doctor licensed by the Florida Board of Medicine. RX A. Respondent, who has been licensed for nearly thirty years, is board certified in internal medicine. Id. Following his residency, Respondent practiced as an emergency room physician for more than twenty years. Id. Respondent previously held a DEA Certificate of Registration, pursuant to which he was authorized to dispense controlled substances in schedules II through V as a practitioner. See GX 2, at 3. However, on July 13, 2011, Respondent surrendered this registration for cause. See GX 3. On July 12, 2012, Respondent applied for a new practitioner's registration, seeking authority to dispense controlled substances in schedules II through V. See GX 1; GX 2, at 1-2. It is this application which is at issue in the proceeding. Respondent's History of Substance Abuse While Respondent has practiced medicine for nearly thirty years (including his residency), in his testimony he admitted to a long history of abusing alcohol and controlled substances. Indeed, he admitted to using alcohol; prescription controlled substances without a prescription; as well as street drugs including marijuana, heroin, cocaine, Ecstasy, and LSD. Tr. 194. Indeed, when asked what drugs he had used beside alcohol, prescription drugs, and heroin, he replied that ``[i]t would be easier to say that I think there's three drugs that I haven't used in my lifetime.'' Id. at 193. Respondent admitted to using alcohol and marijuana beginning at the age of fourteen. Id. at 194. Moreover, while Respondent testified that he ``stopped after some bad things happen[ed] to friends'' and that he ``lost the desire to do that around college time and medical school,'' he began drinking a ``few years into'' his practice as an emergency room physician. Id. at 195. Moreover, Respondent admitted that beginning in 1998, he began abusing Vicoprofen (a controlled substance which contains hydrocodone) samples that he received. Id. at 192. Moreover, Respondent testified that because he had back problems, he had previously obtained some oxycodone ``from a friend who finished his prescription,'' and that on September 11, 2001, he ``woke up and the whole world seemed like it was coming to an end'' so he [[Page 53194]] injected himself with the oxycodone. Id. at 198. According to Respondent, ``it was a very stressful situation that I responded very poorly to by turning to something that I would never have [and had] never done before and didn't see the significance of that action.'' Id. However, the oxycodone ``didn't work because I didn't get it in right and I didn't feel anything.'' Id. As for his abuse of heroin, Respondent testified that in 2003, he encountered J.R., his ex-wife's former boyfriend, at a bar. Id. at 197. According to Respondent, his ex-wife had previously told him to stay away from J.R. because he did heroin. Id. However, because he ``got curious and wanted to try it,'' Respondent apparently approached J.R., who told him that ``he knew where he could get it [heroin] in Tampa, and if I was to buy [J.R.'s], he would . . . make the purchase.'' Id. Respondent drove J.R. to Tampa, and after J.R. procured the heroin, both he and J.R. injected themselves with heroin while in Respondent's car. Id. Subsequently, the police were called to a location in Tampa where they found Respondent and J.R. in the former's vehicle, which was parked with three wheels over the curb and one wheel on the road. GX 4, at 7. Respondent was in the driver's seat, with his eyes open, but was unresponsive when a police officer knocked on the window and shined his flashlight onto Respondent's face. Id. Initially, Respondent was motionless, but he then began to shake every ten seconds. Id. After a short period, J.R. came to and a police officer removed him from Respondent's car and placed him in his patrol car. Id. The officer then returned to Respondent's car and observed a Tampa Fire Department unit giving aid to Respondent (which included the administration of Narcan) and removing him from his car. Id. at 7-8. From outside Respondent's car, the officer saw a metal spoon, which contained a brown substance, on the floor behind the driver's seat. Id. at 7. The officer seized the spoon and field tested the brown substance, which tested positive for heroin. Id. The Office also found an Altoids can on the dashboard in front of the driver's seat; the can held two Q-tip swabs in a small zip-lock bag, a cotton ball, and an alcohol wipe. Id. Another police officer conducted a DUI investigation of Respondent which resulted in his arrest. Id. Thereafter, Respondent's vehicle was impounded and an inventory search was conducted; the search found numerous syringes and a vial of sterile water in the vehicle's console. Id. Thereafter, Respondent was criminally charged with possession of heroin. ALJ Ex. 16 (Gov. Stipulation #5). However, Respondent was offered a pretrial drug intervention program, which he successfully completed and the charges were nolle prossed. Id.; Tr. 231. According to Respondent, as part of the program he was required to undergo an evaluation; however, he told the evaluator that the drugs were not his but J.R.'s, and that he had remained in a nightclub while J.R. had gone out to the car and used the drugs. Tr. 200. As part of the program, he also was required to pass drug tests over the course of a six-month period. Id.; see also id. at 231. Regarding his false statement to the evaluator, Respondent testified that ``unfortunately-- this was an opportunity for me to change . . . to fix the problem, and I don't blame anybody but me because I'm the one who weaseled out of it.'' Id.; see also id. at 230 (``Now I look at that as an opportunity to change my life, and I blame no one but myself for not giving the real information to the counselor. . . .''). Respondent further testified that at the time, he did not think he was an addict, although he ``really was,'' because he had not become physically dependent on heroin and did not go through withdrawal. Id. However, he then explained that he was both ``emotionally'' and ``psychologically dependent'' on the drug. Id. According to Respondent, while he ``knew there was a problem, [he] thought [he] could handle that problem, and that was the biggest problem of it all.'' Id. at 231. As Respondent further testified, ``that's a big problem among physicians because we're supposed to be the ones that fix people. And so if we can't fix ourselves, we have to admit to ourselves that we are not capable of fixing other people either. And that's a pride issue.'' Id. The evidence further shows that in March 2005, a pharmacist contacted the DOH and reported that over a period of several months, she had received prescriptions written by Respondent to B.B. for steadily increasing dosages of OxyContin 80mg, including a recent prescription for 120 dosage units for which B.B. paid $1,172.99 in cash. GX 11, at 3. The pharmacist also reported that Respondent was an emergency room physician and yet he had been writing the prescriptions on blanks that listed his home address and cell phone number. Id. The pharmacist also reported that she had run a physician profile on Respondent and found that all of the other prescriptions that the pharmacy had filled had been written on the prescriptions of the hospital where he worked. Id. After determining that Respondent had not treated B.B. at the hospital where he worked, a DOH Investigator obtained the original prescriptions. The prescriptions showed that between June 19, 2004 and March 23, 2005, Respondent had issued B.B. eleven prescriptions for OxyContin 80mg, which authorized the dispensing of 720 dosage units. GX 11, at 11-19. Consistent with pharmacist's report, the quantity of the dispensings increased from approximately 60 to 120 dosage units per month. Id. at 12. Thereafter, the DOH Investigator, accompanied by a Detective with the Pinellas County Sheriff's Office, went to Respondent's residence where they interviewed both Respondent and B.B. Id. at 3. B.B. told the Investigators that she was Respondent's fianc[eacute] and lived with him. Id. at 4. She also told the Investigators that she had injured her neck in a car accident seven years earlier and had reinjured it during the previous year while on a ski trip. Id. She further told the Investigators that she did not seek treatment at the time of the injury because Respondent ``took over her'' treatment, but that he ``did not do any diagnostic studies of her neck'' nor ``refer her to a specialist.'' Id. Instead, ``he just prescribed OxyContin for pain.'' Id. During his interview, Respondent stated that he was an ER physician at a local hospital and that he ``did not have an outside practice.'' Id. He admitted to writing the prescriptions and corroborated B.B.'s statement that she had reinjured her neck when they were on ski trip. Id. Respondent also eventually admitted that he did not have any medical records for his treatment of B.B., that he had not done a diagnostic workup, and that he had not referred her to a specialist. Id. He then stated that he intended to refer B.B. to a specialist, but had yet to do so. Id. Subsequently, the DOH retained a medical expert who reviewed its investigative file. GX 8. The expert concluded that Respondent's ``care fell well below the standard of care as defined by Floirda[sic] state, local and national norms,'' that OxyContin is ``a strong and highly addictive medication'' which ``requires careful diagnosis and regular reassessment of the patient,'' and that ``[i]t is unacceptable to prescribe the medicine without adequate examination and documentation.'' Id. at 2. The expert further noted that Respondent did not maintain any medical records on B.B., that there was ``no evidence that [[Page 53195]] [Respondent] assessed the patient's medical problems'' and there were ``no known x-rays, lab tests or evaluations.'' Id. The expert thus concluded that Respondent's ``diagnosis was therefore inappropriate and inadequate.'' Id. The expert further concluded that while ``[a] specialist's care was not absolutely essential for such a patient'' and that an ``internist could care for such a patient under different circumstances,'' Respondent committed an ``egregious error'' by prescribing OxyContin to ``an intimate partner . . . over a prolonged period.'' Id. He also noted that ``[n]o obvious plan for long term treatment was identified.'' Id. He thus opined that Respondent's prescribing ``was strikingly inappropriate.'' Id. Thereafter, the DOH issued an administrative complaint to Respondent. The complaint charged Respondent with: 1) failing to practice medicine with that level of care, skill, and treatment of ``a reasonably prudent similar physician . . . under similar conditions and circumstances''; 2) prescribing ``a legend drug, including any controlled substance, other than in the course of the physician's professional practice''; and 3) failing to keep medical records justifying the course of treatment. GX 5, at 15-16, 18. Respondent was allowed to enter into a settlement agreement with the DOH, pursuant to which he was not required to admit the facts of the Administrative Complaint, but did admit that if those facts were proved, they would establish violations of Florida law as alleged in the Complaint. GX 5, at 4. The DOH then reprimanded Respondent; fined him $15,000; required that he reimburse the DOH's costs in an amount up to $2,000; required that he perform 100 hours of community service; and required that he take a course on ``Prescribing Abusable Drugs.'' Id. at 4-7. Regarding these events, Respondent admitted that the facts alleged in the DOH's complaint ``are the facts,'' that his prescribings to B.B. were outside the usual course of professional practice, and that he ``did not'' have a proper medical justification to prescribe to B.B. Tr. 201-03. He also testified that he ``[a]bsolutely'' agreed with the conclusions contained in the DOH Expert's report. Id. at 203. When then asked: ``Is there any part of this report you do not agree with,'' Respondent answered: ``No. It's 100 percent accurate.'' Id. When asked whether the episode had scared him straight or whether he had continued to abuse narcotics, Respondent testified: I was scared into stopping the use of any--doing anything wrong for almost a year after that. But unfortunately I never--because I lied--I may as well--I lied about using the medicines that I prescribed to her myself. Well, I didn't lie. I just never said anything. Nobody asked. Nobody from the Department of Health asked, and I didn't volunteer that information. And unfortunately, as far as I'm concerned, it's a lie, and that lie got me no treatment and no help. And to this day--first of all, if I would have said something the first time with the heroin thing to PRN, my whole life would be different. Id. at 204. Respondent further explained that he and his girlfriend, who had a ``bad neck to begin with,'' were on a one-week long ski-trip in Colorado, and that on the first day, she had ``wiped out on a snowboard'' and ``couldn't move,'' so he called in a prescription for hydrocodone. Id. at 205. Respondent was not sure if he had taken any of the hydrocodone, but believed that he had not because the prescription was for a small quantity which his girlfriend needed to get through the trip. Id. at 205-06. However, upon returning to Florida, Respondent began prescribing oxycodone, and Respondent admitted that by the second prescription, he was ``definitely'' using her oxycodone. Id. at 205. Respondent further admitted that he had changed her prescription to oxycodone because ``if she had them I might be able to get to them.'' Id. at 207. Respondent maintained that after the visit from the DOH and the Detective, he stopped using the drugs but developed ``physical withdrawal symptoms.'' Id. at 208. He then started drinking to deal with the stresses in his life. Id. at 209. Sometime around 2009 or 2010, Respondent was involved in a lawsuit and began injecting heroin again. Id. at 210. Because his use of heroin caused withdrawal symptoms, he also used methadone, which he obtained from his heroin supplier, to counteract those symptoms. Id. at 211. However, because his use of heroin was intermittent, it disturbed his sleep. Id. at 212-13. Respondent testified that he would occasionally use Xanax, which he took from his girlfriend's prescription. Id. at 213. Eventually, Respondent's use of heroin escalated into daily use and the dose needed to avoid becoming sick ``would pretty much double every two or three days.'' Id. at 213-14. Respondent tried to stop twice by going ``cold turkey,'' including once prior to a scheduled ski trip, when he had arranged to have two weeks off from work. Id. at 214. Respondent testified that he had planned on telling his friends that he couldn't go on the trip. Id. at 215. However, after three days of withdrawal his symptoms became unbearable, so he decided to go and ``bought a whole bunch [of] heroin and got as much methadone as [he] could.'' Id. On February 4, 2011, Respondent attempted to leave on the trip. Tr. 84. However, upon going through security at the airport, Respondent was observed ``sweating profusely and shaking'' and was found to be ``in possession of a controlled substance without a prescription.'' Id. Respondent was arrested, and during the search of his person, the police found 34 bags of heroin. Id. at 85. Respondent admitted to the police that the bags contained heroin; a subsequent analysis by a Florida Department of Law Enforcement lab confirmed this. Id. at 85-86. At the time of his arrest, the police also retrieved his checked bags from the airline, and upon searching them, discovered twelve syringes. Id. at 85. Respondent stipulated that at the time of his arrest, he ``was also in possession of'' thirty-seven tablets of methadone 10mg and three tablets of Xanax 2mg, and that he did not have a prescription for either drug. ALJ Ex. 16, at 2 (Gov. Stipulations #9); see also RX C, at 1. While Respondent was again criminally charged, the charges were eventually nolle prossed as well. Tr. 79. However, in contrast to the two previous episodes, Respondent sought the assistance of the Professional Resource Network (hereinafter, PRN), an entity under contract with the DOH to provide assistance to ``licensed professionals . . . who are experiencing difficulties due to some form of impairing illness.'' Id. at 298. Respondent was referred to a treatment program (Health Care Connection) which is run by Dr. David Myers, a Certified Addiction Professional who is both a Diplomate of the America Board of Addiction Medicine and a Fellow of the American Society of Addiction Medicine. Id. at 104; RX E. Dr. Myers testified that he has twenty-five years of experience ``working with chemically dependent people,'' and that ``for the last twenty years,'' his focus has been ``on recovering professionals.'' Tr. 97. Dr. Myers testified that his program has been recognized as a PRN compliant program. Id. at 101. His program evaluates new patients, detoxes and stabilizes them, and ``begin[s] to introduce them into recovery techniques and whatever therapy they may need.'' Id. at 102. According to Dr. Myers, a new patient receives an extensive interview and is subject to either a drug screen or a hair screen after which a [[Page 53196]] treatment recommendation is made. Id. at 105-06. On February 12th (eight days after his arrest), Respondent entered Dr. Myers' program and underwent an initial assessment. According to Dr. Myers, Respondent ``was very transparent,'' ``did not make any attempts to muddy the water,'' and told him ``exactly what happened.'' Id. at 117. A drug test confirmed Respondent's story regarding the drugs he had been abusing. Id. at 110. His treatment included detoxification, followed by 60 days of partial hospitalization which included group therapy, and then entry into a halfway house. Id. at 119-21. Respondent passed all of his drug tests, and according to Dr. Myers ``did very well.'' Id. at 122-23. On May 18, 2011, Respondent entered into a contract with the PRN for a period of five years. RX B, at 6. Pursuant to the contract, Respondent agreed, inter alia, to participate in random drug testing ``within twelve hours of notification''; to abstain completely from the use of any medications, alcohol or other mood altering substances unless prescribed by his physician and to send copies of all such prescriptions to the PRN; to attend recovery group meetings three times per week; and to agree to attend a weekly PRN monitored professional group with his monitoring professional. Id. at 2-3. He also agreed to notify PRN of any changes in his physical or mental health, as well as any change of address or employer; to provide releases for urine screen results, treatment center records and therapist reports; to notify the PRN in the event of his use of ``mood altering substances without a prescription''; to not hold a state dispensing practitioner's license; and to withdraw from practice at PRN's request ``if any problem develops that potentially interferes with [his] professional practice.'' Id. at 3-4. Dr. Myers further testified that Respondent works for him at Health Care Connection and that he performs histories and physicals, ``helps with the detox regimens,'' and helps with sick call. Tr. 124-25. Moreover, Dr. Myers has used Respondent ``to cover the detox unit at'' the Agency for Community Treatment Services, a non-profit, public detoxification unit in Tampa. Id. at 125. According to Dr. Myers, Respondent ``does a good job'' and has ``learned how to share his recovery with other people who are struggling in a way that is appropriate and within a set of medical boundaries.'' Id. at 128. He further testified that if he had ``any doubt that he was risky, I couldn't use him'' because ``[m]y practice is too high profile in my county.'' Id. at 133. Dr. Myers then stated that he ``considers [Respondent] safe or [he] wouldn't have him.'' Id. Dr. Myers also testified that he expects Respondent to continue to do well and that he is fully committed to his recovery. Id. at 132. While Dr. Myers acknowledged that Respondent will never be cured, he expressed his belief that Respondent ``is making it'' and will ``continue to make it.'' Id. Dr. Myers also testified that Respondent had started a new group for recovering doctors in Pinellas County. Id. at 149 & 161. On cross-examination, Dr. Myers acknowledged that he could not guarantee that Respondent would not relapse. Id. at 142. However, when asked if there is a correlation between the length of a person's abuse and the likelihood of relapse, Dr. Myers testified that while ``[t]here are a number of factors which can help predict relapses,'' he did not believe that a correlation has been established between the length of use and the likelihood of relapse. Id. Notably, the Government put forward no evidence to refute Dr. Myers's testimony on this point. For reasons not entirely clear--given that at the time of the hearing, Respondent had been complying with his PRN contract for nearly three years--the Government then asked Dr. Myers: Q. So you're telling me that a person has the same amount of percentage of relapsing . . . [who] is drug tested weekly, [goes to] weekly community meetings, you think that that provided the same type relapse percentage as a person who is without any supervision . . . at all? A. We know that it takes five years to reach maximum benefit in recovery, where the relapse rates then become pretty consistent over time, whether it's five years or 10 years or 15 years. Id. at 143. Dr. Myers then explained that this was based on ``five years of monitoring.'' Id. at 144.\2\ --------------------------------------------------------------------------- \2\ The Government then asked Dr. Myers if he had ``compared data for treated monitoring versus untreated monitoring?'' Tr. 144. While Dr. Myer replied that ``[t]hat has been done, but only in the first two to three years of the recovery process,'' id., the record does not establish what ``untreated monitoring'' involves. Subsequently, Dr. Myers testified that the PRN had initially used ``a two-year contract'' but found that ``too many docs and . . . healthcare professionals [were] relapsing following the two years.'' Id. at 147. Dr. Myers then explained that the PRN contract was lengthened ``to five years, which is what studies suggest . . . is a solid recovery time'' and that ``the percentage of relapse is very low'' for those persons who complete five years. Id. --------------------------------------------------------------------------- Another physician, who is both a fellow staff member at Health Care Connection and a recovering physician who participated in the same recovery group as Respondent, id. at 159-62, testified that Respondent has been ``very open and honest about his addiction as well as his recovery'' and that ``he definitely has an interest in helping others who are afflicted with the same disease.'' Id. at 163. Still another physician, who has worked with and supervised Respondent at Health Care Connection testified that he had not observed Respondent engage in any conduct demonstrating that he is not ``a safe and responsible'' physician and that Respondent is ``passionate about'' his recovery. Id. at 182-83. Respondent also called as a witness, Dr. Penelope Ziegler, the Medical Director and CEO of PRN, Inc. Id. at 298. Dr. Ziegler is board certified in Psychiatry and Addiction Psychiatry, as well as certified in Addiction Medicine by the American Board of Addiction Medicine. Id. at 299. Since the completion of her residency in 1982, Dr. Ziegler has ``focused [her] professional activities on the treatment of addiction'' as well as ``other psychiatric disorders.'' Id. Prior to her present positions, she was the medical director of similar programs in Pennsylvania and Virginia. Id. After explaining the PRN's program, Dr. Ziegler testified that Respondent ``has been entirely compliant with his contract and [that] we have received all of his reports as scheduled . . . indicating continued progress.'' Id. at 306. She further testified that ``all of [Respondent's] urine screens have been negative,'' and thus she believes that he has not been using controlled substances illegally. Id. Corroborating Dr. Ziegler's testimony, Respondent submitted a Test History Report listing each drug test he had undergone between June 6, 2011 and January 28, 2014; the report indicates that each test was negative. RX D. Dr. Ziegler further testified that Respondent's contract is scheduled to end on May 18, 2016. Tr. 307. She then explained that PRN offers most doctors the ``opportunity to extend their monitoring beyond the five years if they choose,'' and that if a doctor agrees to do so, they are given a contract for ``extended monitoring.'' Id. While this contract does not require continued attendance at group meetings, it still requires urine screening. Id. Dr. Ziegler also noted that in some cases, PRN offers a physician a ``licensure long contract.'' Id. at 308. Dr. Ziegler explained that a ``licensure long contract . . . is sometimes required by the Board of Medicine'' where the Board believes that a physician is an ``ongoing risk of relapse without monitoring.'' Id. [[Page 53197]] However, a physician can voluntarily request a licensure-long contract, which remains in effect until the physician retires, voluntarily relinquishes his license, or some ``untoward circumstances'' arise. Id. at 309. Dr. Ziegler testified that one of the terms of Respondent's PRN contract is that he is required to obtain ``permission from PRN to return to practice.'' Id. at 310. She further testified that Respondent has complied with each of the conditions of the contract, as well as all federal and state laws related to controlled substances while he has been in the PRN's program. Id. at 311-12. On cross-examination, Dr. Ziegler acknowledged that Respondent could ``walk away from'' his PRN contract at any time if he chose to do so. Id. at 312. However, she also explained that if he did so, he would be ``immediately reported'' to the DOH. Id. at 313. She also maintained that if she had reason to believe that he poses ``an immediate danger to the public health,'' she would also contact the Chief of the DOH's Prosecutorial Services Unit. Id. at 314. However, Dr. Ziegler acknowledged that in such a scenario, only the DOH has authority to issue an emergency suspension of Respondent's medical license. Id. at 321; 323. When asked (on re-direct examination) if granting prescribing authority to Respondent would pose ``any safety issue,'' Dr. Ziegler testified: No. And people at his stage of recovery and at his point in monitoring with us, lots of those practitioners hold DEA certificates and use them in the course of their practice of medicine. You know, having prescribing privileges, there's a certain amount of risk associated with it. But at his stage of the game it certainly is not something we would be concerned about because he is doing very well. Id. at 317-18. Dr. Ziegler then explained that if Respondent was to obtain employment in an emergency room, the PRN would ``want to have some kind of an understanding with his employer . . . so that we had permission to talk to them if we were concerned or they had permission to talk to us if they were concerned,'' and that Respondent would have to agree to this before the PRN would allow him to accept the position. Id. at 318. And she further testified that were Respondent to accept a position in an emergency room without notifying the PRN, this would constitute a material breach of the PRN contract and he would be immediately pulled from practice and required to undergo a new evaluation. Id. Following questioning by the parties, the ALJ asked Dr. Ziegler ``what significance [she] attach[ed] to the premise of a stable recovery [being] measured in terms of five years?'' Id. at 325. Dr. Ziegler answered: Right now that is sort of a standard accepted practice in all of the professional monitoring programs that are members of a group called the Federation of State Physician Health Programs. It used to be three years and it was extended to five years because there was [sic] some research studies that showed that three years may not be long enough and that relapses did frequently occur at the three-year point, although we don't really fully understand why because the research isn't there to demonstrate it. But that's pretty much a standard operating procedure for most of these monitoring programs around the country. It definitely seems to correlate with outcome data that says the chances of relapse after five years of stable monitored recovery is greatly lessened compared to people who are not monitored. And that's kind of the best answer I can give you. There's nothing really all that magic [sic] about five years. It's just that that's kind of a standard these days. Id. at 325-26. The ALJ then asked Dr. Ziegler what ``it means to represent that someone is safe to practice?'' Id. at 326. Dr. Ziegler answered: Well, when we make that kind of representation, we're basing that on reports that we receive from the treating professional involved with this person's individual situation at the outset and then as we go along, also with the results of our frequent random drug testing and our contact with the person, mostly over the phone, as they go through our program. . . . what I usually say if I'm writing a letter to the Board of Medicine or to a potential employer or to an insurance company or to the DEA is in my professional opinion[,] this person is safe to practice with reasonable skill and safety. I believe that when somebody is in our monitoring program and has done well for a period of time that they are as safe to practice with reasonable skill and safety as someone who has never been identified as having a problem. Id. at 326-27. Finally, the ALJ noted that Respondent's PRN contract includes a provision which states that PRN ``agrees to assume an advocacy role with [the] Professional Licensing Board, hospital board, and other appropriate agencies, provided the above listed terms are agreed to and met.'' RX B, at 6 (emphasis added). The ALJ then asked Dr. Ziegler whether DEA was considered to be ``such an agency.'' Tr. 329. Dr. Ziegler answered: Well, I'm not wild about that term ``advocacy,'' but I'll buy it temporarily and say yes. I mean, advocacy means that we are willing to do something like today . . . . You're having a hearing and I'm willing to come and testify that this person has done the right thing and is safe to practice and whatever. If that's what you mean by advocacy, yeah, that's what we do, part of what we do. And the other part of what we do is we withdraw advocacy if it's no longer wanted or warranted . . . because otherwise our credibility is no good. . . . Our credibility depends upon our willingness to withdraw our advocacy if the person no longer warrants that advocacy. Id. at 329-30. On further questioning by Respondent's counsel, Dr. Ziegler testified that it was ``correct'' that 85 to 90 percent of PRN's patients ``comply with their contract[s] and ``make it.'' Id. at 331. However, on re-cross examination, Dr. Ziegler acknowledged that she could not guarantee that Respondent would never relapse. Id. at 331-32. In addition to his previous testimony regarding the various incidents, Respondent admitted that he had probably used drugs when he was working. Id. at 216. When asked how long he would continue to be actively monitored, Respondent answered: ``the rest of my life, if it can happen.'' Id. at 219; see also id. at 256 (expressing willingness to sign lifelong PRN contract). He further testified that during the fourth year of monitoring, he would be subject to eighteen urine tests as well as a hair test every three months, and that in the fifth year of his PRN contract, he would be subject to twenty-four urine tests. Id. at 220. However, Respondent did not know how many urine tests would be conducted each year if he contracted for additional monitoring. Id. Respondent then acknowledged that both the DOH and this Agency could require that he stay in the PRN program. Id. at 221. Respondent also acknowledged that as an emergency room physician, at times he did experience ``great stress.'' Id. at 224. Respondent explained, however, that ``most of the time, I was able to handle that, and that's without having any knowledge [of] how to do it.'' Id. Respondent further agreed that his recovery will be ``a lifelong struggle'' and that he could not guarantee that he will never relapse. Id. at 225-26. He further testified that he accepted all responsibility for ``all of these violations that [he] had both as related to controlled substances and the way that [he] practice[d] medicine outside . . . of [the] standards of care.'' Id. at 249. DISCUSSION Section 303(f) of the Controlled Substances Act (CSA) provides that ``[t]he Attorney General may deny an application for [a practitioner's] [[Page 53198]] registration . . . if [he] determines that the issuance of such registration . . . would be inconsistent with the public interest.'' 21 U.S.C. Sec. 823(f). In making the public interest determination, the CSA directs that the following factors be considered: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing . . . controlled substances. (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. ``[T]hese factors are . . . considered in the disjunctive.'' Robert A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a combination of factors and may give each factor the weight I deem appropriate in determining whether to deny an application for a registration. Id. Moreover, I am ``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 Government has ``the burden of proving [by substantial evidence] that the requirements for . . . registration . . . are not satisfied.'' 21 CFR 1301.44(d); see also 5 U.S.C. Sec. 556(d). However, where the Government has met its prima facie burden of showing that issuing a new registration to the applicant would be inconsistent with the public interest, a respondent must come forward with ``sufficient mitigating evidence'' to show why he can be entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). Moreover, because `` `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Cuong Tron Tran, 63 FR 64280, 64283 (1998); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an ``important factor[ ]'' in the public interest determination). Even so, at all times, the burden of proof on the ultimate issue of whether an applicant's registration is inconsistent with the public interest remains with the Government. 5 U.S.C. Sec. 556(d); 21 CFR 1301.44(d). Having considered all of the factors,\3\ I hold that the Government has met its prima facie burden of showing that Respondent has committed acts which render his registration ``inconsistent with the public interest.'' 21 U.S.C. Sec. 823(f). However, I further find that Respondent has accepted responsibility for his misconduct. Moreover, I hold that in the event Respondent produces evidence that he has continued to comply with his PRN contract and has passed all drugs tests administered to him since January 28, 2014, he will have produced sufficient evidence of his successful rehabilitation and will have rebutted the Government's prima facie case. --------------------------------------------------------------------------- \3\ As for factor one, the recommendation of the state licensing authority, the DOH has not made a recommendation to the Agency as to whether Respondent should be granted a new DEA registration. Moreover, although Respondent is currently licensed by the State and thus satisfies an essential condition for obtaining a registration, see 21 U.S.C. Sec. Sec. 802(21) & 823(f), this `` `is not dispositive of the public interest inquiry.' '' George Mathew, 75 FR 66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, No. 10- 73480, slip op. at 5 (9th Cir., Mar. 16, 2012); see also Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003). As the Agency has further held, ``the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992). Thus, this factor is not dispositive either for, or against, the granting of Respondent's application. Paul Weir Battershell, 76 FR 44359, 44366 (2009) (citing Edmund Chein, 74 FR 6580, 6590 (2007), pet. for rev. denied Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)). Regarding factor three, there is no evidence that Respondent has been convicted of an offense related to the manufacture, distribution or dispensing of controlled substances. However, as there are a number of reasons why a person may never be convicted of an offense falling under this factor, let alone be prosecuted for one, ``the absence of such a conviction is of considerably less consequence in the public interest inquiry'' and thus, it is not dispositive. David A. Ruben, 78 FR 38363, 38379 n. 35 (2013) (citing Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)). --------------------------------------------------------------------------- Factor Two--Respondent's Experience in Dispensing Controlled Substances Pursuant to a longstanding agency regulation, ``[a] prescription for a controlled substance [is not] effective [unless it is] issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.'' 21 CFR 1306.04(a). The regulation further provides that ``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 issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.'' Id. As the Supreme Court has explained, ``the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), cert. denied, 574 U.S. 1113 (2006) (the prescription requirement stands as a proscription against doctors acting not ``as a healer[,] but as a seller of wares''). Under the CSA, it is fundamental that a practitioner must establish and maintain a legitimate doctor-patient relationship in order to act ``in the usual course of . . . professional practice'' and to issue a prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73 FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence established that physician exceeded the bounds of professional practice, when ``he gave inadequate physical examinations or none at all,'' ``ignored the results of the tests he did make,'' and ``took no precautions against . . . misuse and diversion''). The CSA, however, generally looks to state law to determine whether a doctor and patient have established a legitimate doctor-patient relationship. Volkman, 73 FR at 30642. As found above, it is undisputed that Respondent issued multiple prescriptions for a total of 720 dosage units of OxyContin 80mg in a manner which violated both the CSA's prescription requirement and Florida law. As the evidence shows, while Respondent wrote the prescriptions for his girlfriend, and maintained that he had done so because she had re-injured her neck while snowboarding on a ski trip, he admitted that shortly after returning from the trip, he had changed her prescription from hydrocodone to OxyContin so that he could obtain the drugs to abuse them and that he took [[Page 53199]] some portion of the OxyContin he prescribed. Tr. 205 & 207. An expert retained by the DOH found that Respondent did not maintain medical records, that there was no evidence that he had assessed his girlfriend's medical problems and that his diagnosis was ``inappropriate and inadequate.'' GX 8, at 2. The DOH's expert also found that Respondent had not created a treatment plan. The DOH's expert thus concluded that Respondent's prescribing ``fell well below the standard of care as defined by'' both state and national norms and that he committed ``egregious error'' by prescribing to ``an intimate partner . . . over a prolonged period.'' Id. Moreover, Respondent fully admitted that he did not have a proper medical justification to prescribe to his girlfriend and that the prescriptions were issued outside of the usual course of professional practice. I therefore find that Respondent violated both the CSA's prescription regulation, see 21 CFR 1306.04(a), and Florida law, which prohibits the prescribing of ``any controlled substance, other than in the course of the physician's professional practice.'' Fla. Stat. Sec. 458.331(1)(q); see also 21 U.S.C. Sec. 841(a)(1) (``[e]xcept as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally . . . to dispense . . . a controlled substance''). Against this evidence, Respondent testified as to the training he received in his residency regarding the dispensing of controlled substances, his more than twenty years of experience in dispensing controlled substances as an emergency room physician, and there is no evidence that he has otherwise knowingly diverted controlled substances. He also testified that pursuant to the DOH's order, he had taken a course on the proper prescribing of controlled substances. Be that as it may, the finding that he violated both the CSA and federal law in issuing the OxyContin prescriptions is evidence of his experience in dispensing controlled substances even if it is also evidence of his noncompliance with applicable laws related to controlled substances. And by itself, this finding is sufficient to support the conclusion that the Government has established a prima facie case to deny Respondent's application. I thus reject the ALJ's conclusion that factor two ``neither supports nor contradicts'' Respondent's application. The ALJ's analysis of Factor Two nonetheless warrants further discussion. More specifically, the ALJ opined that: [T]here also is evidence of acts by [Respondent] that do not constitute noncompliance with law but still suggests experience that may threaten the public interest. There is, for example, no law against being familiar with that part of society that deals in illicit drug trafficking. Over the years while he was buying heroin and other drugs on the street, [Respondent] has become very well acquainted with those in the community who have chosen to traffic in heroin. A person with that kind of experience, particularly one authorized to write prescriptions for narcotics and other controlled substances, holds a highly valuable key recognized by those in our society who are likely to try to exploit that authority to advance their own illicit goals. Restoring to [Respondent] the ability to prescribe controlled substances carries with it some risk, given the unique skill set [Respondent] developed while seeking heroin and other addictive drugs on the street. While he may well be able to resist efforts from those in the trafficking trade to recruit him during periods of sustained stable recovery, were he to relapse those illicit efforts may well prove successful, creating a significant risk of prescription drug diversion. R.D. at 37-38. The ALJ's reasoning finds no warrant in the text of Factor Two. Contrary to the ALJ's understanding, factor two does not call for an inquiry into a practitioner's life experience generally or even his experience related in any manner to controlled substances, but rather, only his ``experience in dispensing, or conducting research with respect to controlled substances.'' See 21 U.S.C. Sec. 823(f)(2). While writing controlled substance prescriptions which were then traded for street drugs would clearly be actionable misconduct under this factor, there is not even an iota of evidence in this record that Respondent ever traded controlled substance prescriptions for drugs he obtained on the street. In the absence of any such evidence, the ALJ's reasoning is nothing more than unsupported speculation. Accordingly, I reject it. Factor Four--The Applicant's Compliance With Applicable Laws Related To Controlled Substances In addition to the prescribing violations discussed above, Respondent committed additional violations of both the CSA and Florida laws when he unlawfully possessed controlled substances and drug paraphernalia. With respect to the 2003 incident, Respondent clearly possessed heroin and drug paraphernalia (i.e., a syringe) when he injected himself with the heroin. Respondent's conduct violated both the CSA, see 21 U.S.C. Sec. 844(a) (simple possession), as well as Florida law. See Fla. Stat. Sec. 893.13(6)(a) (unlawful possession); id. Sec. 893.147(1)(b) (prohibiting use of drug paraphernalia ``[t]o inject . . . a controlled substance in violation of this chapter''); id. Sec. 893.145(11) (defining drug paraphernalia as including ``[h]ypodermic syringes, needles, and other objects used, intended for use, or designed for use in parenterally injecting controlled substances into the human body''). So too, because Respondent did not obtain the OxyContin he admitted to abusing ``pursuant to a valid prescription from a practitioner,'' or obtain it in a manner otherwise authorized by the CSA, he also unlawfully possessed those drugs. 21 U.S.C. Sec. 844(a); see also Fla. Stat. Sec. 893.13(6)(a). Likewise, at the time of the 2011 Tampa Airport incident, Respondent was in found to be in possession of heroin, methadone, and Xanax (alprazolam), as well as multiple syringes. Heroin is a schedule I drug, as it has no accepted medical use; Respondent thus had no authority to possess the drug under his registration. See 21 CFR 1308.11(c); GX 2, at 3; 21 U.S.C. Sec. 822(b). Nor did Respondent dispute that he did not have prescriptions for the methadone and Xanax. Thus, here again, Respondent violated the CSA and Florida law by unlawfully possessing controlled substances. 21 U.S.C. Sec. 844(a); see also Fla. Stat. Sec. 893.13(6)(a). Moreover, his possession of the syringes also violated Florida law. Fla. Stat. Sec. 893.147 (prohibiting the possession, with intent to use, of drug paraphernalia); id. Sec. 893.145(11). Here again, Respondent does not dispute that he engaged in the above acts. Respondent's extensive record of non-compliance with the CSA and Florida laws related to controlled substances thus provides further support for the conclusion that the Government has established a prima facie case to deny his application. Factor Five--Such Other Conduct Which May Threaten Public Health and Safety DEA precedent has long recognized that a practitioner's self-abuse of controlled substances constitutes misconduct which is actionable under this factor. Tony T. Bui, 75 FR 49979, 49989 (2010) (citing, inter alia, David E. Trawick, 53 FR 5326, 5327 (1988); William H. Carranza, 51 FR 2771 (1986)). Here, it is undisputed that Respondent has a long and disturbing history of abusing controlled substances. Moreover, Respondent admitted that he had probably been under the influence of controlled substances while at work. This factor thus provides further support for the Government's prima facie case. [[Page 53200]] The ALJ further found that beyond this evidence, Respondent, when ``not in stable and sustained recovery . . . has a demonstrated tendency towards lying in the course of responding to governmental processes.'' R.D. 40. As support for his conclusion, the ALJ explained that ``[h]is decision to deny his possession of heroin when interviewed by a court evaluator following his 2003 overdose is one example; his failure to disclose to the Florida Department of Health that he was diverting OxyContin for his own use in 2006 is another example.'' Id. The ALJ then suggested that Respondent gave false testimony in this proceeding. More specifically, the ALJ reasoned that: Further, his testimony in these proceedings, to the effect that the expert evaluation presented to the Florida [DOH] in 2005 by [its] expert was ``100 percent accurate'' cannot be reconciled with the fact that [the expert's] report made no mention of the whole truth here--that [he] had been diverting [his girlfriend's] OxyContin for his own use, for two years. Dr. Greenstein's report was not ``100 percent accurate,'' and it was inaccurate with respect to a material condition that apparently has never been disclosed to the Florida medical authorities. Id. However, the ALJ then explained that ``that the evidence does not compel, or even permit, a finding that [Respondent] currently presents a threat to the public due to a predisposition to prevaricate.'' Id. at 41. The ALJ further explained that he did ``not detect a present threat here,'' as he believed that Respondent ``can be relied upon to be forthright and candid during his recovery.'' Id. (emphasis added). Nonetheless, because Factor Five directs that the Agency consider ``conduct which may threaten the public health and safety,'' the ALJ then reasoned that ``[a] chronic history of substance abuse, coupled with a pattern of misleading governmental officials when the abuse created significant problems for [him], is evidence of conduct that may threaten public health and safety.'' Id. (emphasis added). As stated above, I agree with the ALJ that the evidence shows that Respondent has a chronic history of substance abuse. However, I reject his conclusion that the evidence establishes that Respondent has ``a demonstrated tendency towards lying'' to government officials and a ``pattern of misleading'' them. To be sure, the evidence shows that in 2003, Respondent falsely stated to the evaluator for the pretrial drug intervention program that the heroin found in his vehicle was not his. The evidence does not, however, support either the ALJ's conclusion that he lied to the Florida Department of Health because he failed to disclose to it that he was using the OxyContin he prescribed to B.B. or the ALJ's suggestion that he gave false testimony in this proceeding. As for the former, there is no evidence that Respondent was ever asked by the DOH's investigator whether he was using the OxyContin and Respondent testified that ``[n]obody from the [DOH] asked, and I didn't volunteer that information.'' Tr. 204. Thus, Respondent did not lie to the DOH. To the extent the ALJ's conclusion rests on the theory that Respondent misled the DOH by failing disclose to it that he was using the OxyContin, the Government made no such argument and the ALJ cited no authority for the proposition that Respondent had a duty under Florida law to disclose this information to the DOH. So too, I find unwarranted the ALJ's suggestion that Respondent gave false testimony when he testified that the DOH expert's report was ``100 percent accurate.'' R.D. at 40. While the ALJ reasoned that the expert's ``report was not `100 percent accurate' '' because it ``made no mention of the whole truth,'' that being that Respondent was using his girlfriend's OxyContin, there is no evidence that the expert ever interviewed Respondent. Indeed, the expert's report stated that he had only reviewed the investigative file prepared by the DOH. Moreover, the ALJ's suggestion cannot be sustained upon reviewing the entirety of Respondent's testimony regarding the DOH expert's report. Cf. Meyers v. United States, 171 F.2d 800, 806-07 (D.C. Cir. 1948) (a ``statement may not be isolated and thereby given a meaning wholly different from the clear significance of the testimony considered as a whole''). As found above, Respondent answered ``absolutely'' when asked by the Government whether he agreed with the expert's conclusions. Tr. 203. Notably, those conclusions included that there was no evidence that he had assessed B.B.'s medical problems and that his ``diagnosis was therefore inappropriate and inadequate''; that his ``care fell well below the standard of care as defined by Florida statute, local and national norms''; that the ``prescription of OxyContin was strikingly inappropriate''; that he committed an ``egregious error'' by providing ``high-volume, long duration'' prescriptions ``of a highly abused narcotic to a patient with whom he had an intimate relationship.'' GX 8, at 2-3. Respondent thus admitted to having committed egregious misconduct. Viewed in this context, his answer to the Government's subsequent question, which asked if there was ``any part of'' the report that he did ``not agree'' with, and to which he answered, ``No. It's 100 percent accurate,'' cannot reasonably be construed as false.\4\ --------------------------------------------------------------------------- \4\ Indeed, while the ALJ reasoned that the report was not 100 percent accurate because it made no mention of Respondent's diverting the drugs to his own use, there is not a single statement in the report which appears to be untrue. --------------------------------------------------------------------------- Accordingly, I reject the ALJ's analysis that Respondent has demonstrated a pattern of misleading governmental officials when his substance abuse ``created significant problems for'' him. R.D. at 41. However, his substance abuse alone supports a finding that he has engaged in conduct which may threaten public health and safety. Summary As found above, the Government's evidence with respect to factors two, four and five, establishes that Respondent wrote unlawful prescriptions, unlawfully possessed controlled substances, unlawfully possessed drug paraphernalia, and has a long history of substance abuse. Accordingly, the Government has established a prima facie case to deny Respondent's application on the ground that his registration ``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). Indeed, in his post-hearing brief, Respondent concedes as much. SANCTION As explained above, where the Government has met its prima facie burden of showing that issuing a new registration to the applicant would be inconsistent with the public interest, a respondent must come forward with `` ` ``sufficient mitigating evidence'' ' '' to show why he can be entrusted with a new registration. Medicine Shoppe- Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. [[Page 53201]] Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an ``important factor[]'' in the public interest determination). Here, the ALJ found that Respondent has accepted responsibility for his misconduct. R.D. at 42. However, the ALJ concluded that Respondent has not produced sufficient evidence of his rehabilitation to rebut the Government's prima facie case. Id. As the ALJ explained: The record before me establishes that when sober and compliant with his recovery program, [Respondent] can be relied upon to avoid engaging in behavior that threatens the public interest. Thus, the risk of relapse becomes critical in determining what steps are warranted when determining the public interest. Here, testimony from Drs. Ziegler and Myers establishes that the risk of relapse is high, and will continue to be high for [Respondent], throughout the five years following the commencement of his recovery. The evidence fully supports a finding that [Respondent's] recovery since February 2011 has been stable and successful. The evidence also supports a finding, however, that insufficient time in stable recovery has passed to support a finding that corrective action has been taken. . . . Surely steps that may lead to effective corrective action have begun, but those steps are not complete, and in the absence of evidence of complete corrective actions the Respondent has not, by a preponderance, presented evidence that would permit the restoration of his . . . [r]egistration. Id. at 42-43. I do not dispute the ALJ's premise that ``the risk of relapse [is] critical in determining what steps are warranted'' to protect the public interest. I reject, however, the ALJ's conclusion that until Respondent successfully completes a full five years in the PRN's program, he presents an unacceptable risk of relapse. Not only does the ALJ's conclusion rest on a misreading of the testimony of both Drs. Myers and Dr. Ziegler, it cannot be reconciled with numerous agency precedents which have granted new registrations to self-abusing practitioners who have undergone treatment and demonstrated rehabilitation well before completing five years of treatment in a PRN program.\5\ While there may be a variety of factors present in any self-abuse case which support a finding that a practitioner continues to poses an unacceptable risk of relapse (even after completing multiple years of sustained recovery), a categorical rule that a practitioner cannot be registered before completing five years in a PRN program is inherently arbitrary. --------------------------------------------------------------------------- \5\ See Perry T. Dobyns, 77 FR 45656 (2012) (granting restricted registration based on less than three years of demonstrated sobriety following physician's relapse); Stephen Reitman, 76 FR 60889 (2011) (granting restricted registration where evidence at hearing established only one year of sobriety); Michael Moore, 76 FR 45867 (2011) (suspending but not revoking registration where physician, who abused marijuana, had demonstrated sobriety for less than four years); Karen Kruger, 69 FR 7016 (2004) (granting registration after three and a half years of demonstrated sobriety); Jimmy H. Conway, Jr., 64 FR 32271 (1999) (granting registration after three years of demonstrated sobriety). --------------------------------------------------------------------------- Contrary to the ALJ's reasoning, neither the testimony of Dr. Myers nor Dr. Ziegler ``established [that] a material risk of relapse exists during the first five years of stable recovery'' for either professionals generally or Respondent specifically. Indeed, in concluding that Respondent continues to present an unacceptable risk of relapse and will do so until he completes a full five years in the PRN program, the ALJ ignored extensive evidence offered by Respondent to the contrary. As found above, Dr. Myers testified that the PRN initially used ``a two-year contract'' but found that ``too many docs and . . . healthcare professionals [were] relapsing following the two years.'' Tr. 147. He then explained that PRN lengthened the contract term to five years because ``studies suggest'' that five years ``is a solid recovery time'' which provides ``maximum benefit'' and that ``the percentage of relapse is very low'' for those persons who complete the five-year contract. Id. Notably, Dr. Myers did not testify as to the specific relapse rate of those doctors who had completed a two-year contract. Most significantly, his testimony suggests only that the relapse rate was unacceptably high for those doctors who had completed their two-year contracts and were no longer subject to monitoring and other contract requirements. This, of course, says nothing about the relapse rate of those doctors who continued to be subject to monitoring after completing a two-year contract. As for Dr. Myers' further testimony that various studies suggests that five years ``is a solid recovery time'' which provides ``maximum benefit'' and that the ``percentage of relapse is very low'' for those persons who complete a five-year contract, while this explains why PRNs have lengthened their contracts to five years, it too says nothing about the actual risk of relapse for those physicians who remain subject to, and in compliance with, a PRN contract through years three, four, and five of their contracts. To be sure, Dr. Ziegler testified that PRN contracts ``used to be three years'' but were ``extended to five years because . . . some research studies . . . showed that three years may not be long enough and that relapses did frequently occur at the three-year point.'' Tr. 325-26. However, even assuming that these studies involved physicians who were still subject to PRN monitoring at the time of their relapses, no further testimony was elicited from Dr. Ziegler as to what the actual rate of relapse was at three years and various times thereafter.\6\ --------------------------------------------------------------------------- \6\ The conclusion that because PRN programs have extended their monitoring contracts to five years, a physician under such a contract invariably presents an unacceptable risk of relapse until he completes a full five years of compliance, was refuted by Dr. Ziegler's testimony. See Tr. 317-18. The Agency's case law also suggests that this conclusion is inconsistent with the understanding of state medical boards, which have frequently issued new licenses to practitioners before the practitioners have demonstrated five years of sobriety. --------------------------------------------------------------------------- In short, neither the testimony of Dr. Myers nor of Dr. Ziegler establishes what the relapse rate is for physicians who remain subject to monitoring during the fourth and fifth years of a PRN contract as a general matter, let alone for physicians who present particular risk factors for relapse. And in any event, Respondent is now well past three years of successful compliance with his PRN contract and through the closing of the record, he has passed every drug test since seeking treatment in February 2011. Moreover, both Dr. Myers and Ziegler offered extensive evidence of Respondent's commitment to his recovery and compliance with his PRN contract. Yet this evidence is barely acknowledged in the recommended decision. Notably, Dr. Myers, who, in addition to being a Diplomate of the American Board of Addiction Medicine and a Fellow of the American Society of Addiction Medicine, has twenty-five years of experience working with chemically dependent persons, with twenty of those years focused on recovering professionals, testified that he employs Respondent in his practice, that he considers him safe, and that if he had ``any doubt that [Respondent] was risky, he couldn't use him.'' Tr. at 133. Dr. Myers also testified that while Respondent will never be cured, he believes that Respondent is fully committed to his recovery, that he ``is making it'' and that he will ``continue to make it.'' Id. at 132. Dr. Ziegler, who is board certified in Psychiatry and Addiction Psychiatry, as well as Addiction Medicine, and has focused her professional activities on the treatment of addiction, testified that [[Page 53202]] Respondent has passed all of his urine screens and ``has been entirely compliant with his contract.'' Tr. 312. In his decision, the ALJ asserted that, because the PRN contract obligates the PRN ``to assume an advocacy role'' with licensing agencies provided Respondent complied with the terms of his contract, her testimony ``should be treated as advocacy, rather than as independent and unbiased medical testimony.'' R.D. at 32. However, Dr. Ziegler further explained that PRN will ``withdraw our advocacy if the person no longer warrants that advocacy.'' Tr. 330. Accordingly, I do not find that the existence of the PRN contractual provision warrants giving less than full weight to her testimony.\7\ --------------------------------------------------------------------------- \7\ Notably, other than the contractual provision, there is no evidence on Dr. Ziegler's part of the existence of any other of the typical sources of partiality. Of further note, neither the Government nor the ALJ identify a specific instance in which Dr. Ziegler's testimony lacked objectivity. As for Dr. Myers, the Government argues that his testimony should be given ``the same scrutiny as Dr. Ziegler['s]'' because he has a long association with PRN and ``should be viewed as an agent of PRN.'' Gov. Br. at 21-22. Here again, I find the Government's argument unpersuasive and do not find that any portion of his testimony lacks credibility. --------------------------------------------------------------------------- While Dr. Ziegler testified that she could not guarantee that Respondent would never relapse, she also testified that granting Respondent prescribing authority would not pose a safety issue. As she explained: people at his stage of recovery and at his point in monitoring with us, lots of those practitioners hold a DEA certificate and use them in the course of their practice of medicine. . . . [H]aving prescribing privileges, there's a certain amount of risk associated with it. But at this stage of the game it certainly is not something we would be concerned about because he is doing very well. Tr. 317-18. Dr. Ziegler also testified that when PRN represents to a licensing body that a practitioner is safe to practice, its representation is based on the reports it has received from the physician's treating professional who is aware of the physician's individual situation, the results of the random drugs screens it has conducted, and its contact with the physician as he/she goes through the program. Id. at 326-27. And she further testified ``that when somebody is in our monitoring program and has done well for a period of time [he/she is] as safe to practice with reasonable skill and safety as someone who has never been identified as having a problem.'' Id. at 327. The Government also argues that Respondent's application should be denied because he failed to produce evidence supporting his application ``from independent medical professionals.'' Gov. Br. 20. It is not entirely clear what, in the Government's view, qualifies a medical professional as ``independent.'' However, in self-abuse cases, this Agency has never required a practitioner to present evidence from a medical professional who either does not have a doctor-patient relationship with the physician or is not otherwise involved in the physician's recovery.\8\ Rather, the Agency has frequently granted new registrations to practitioners based on the reliable testimony of treating professionals. To the extent the Government believes that neither Dr. Myers nor Dr. Ziegler were objective witnesses in their assessments of Respondent's risk of relapse, it bears noting that there is independent medical evidence of Respondent's successful rehabilitation--this being the numerous random drug tests he has passed. And nothing prevented the Government from retaining an expert who could have reviewed Respondent's treatment records and rendered an opinion on whether he presents an unacceptable risk of relapse. --------------------------------------------------------------------------- \8\ It is far from clear whether, under Florida law, Dr. Ziegler, as PRN program director, has a doctor-patient relationship with the PRN's clients. --------------------------------------------------------------------------- The Government also argues that because of ``his long-term drug abuse,'' Respondent should not be granted a registration until he has completed a minimum of ``five years of monitored treatment.'' Gov. Br. at 19. Notably, the Government produced no evidence establishing that physicians with a long history of abuse have a greater risk of relapse than other physicians. Indeed, when asked by the Government whether there is a correlation between a physician's length of abuse and the likelihood of relapse, Dr. Myers testified that while ``there are a number of factors which can help predict relapses,'' he did not believe that a correlation has been established between the length of abuse and the likelihood of relapse. The Government offered no evidence to refute this testimony. Moreover, while Dr. Myers testified that there are a number of factors that predict relapses, the Government did not elicit any testimony from Dr. Myers or offer any other evidence establishing what those factors are and whether they are present in Respondent's case. It bears noting that while Respondent had the burden of producing sufficient evidence to establish that he has undertaken sufficient corrective measures such that he is not likely to re-offend, the Government, at all times, retains the burden of proving that granting his application is inconsistent with the public interest. 5 U.S.C. 556(d); 21 CFR 1301.44(d). Accordingly, I reject the Government's contention that Respondent presents an unacceptable risk of relapse until he successfully completes a full five years in the PRN program. I therefore conclude that provided Respondent has continued to comply with his PRN contract and has passed all drug tests since the closing of the record, he is entitled to be registered. Accordingly, Respondent is directed to provide evidence of all drug test results conducted since January 28, 2014 and his continued compliance with his PRN contract.\9\ In the event Respondent has failed any of the drug tests, or has not remained in compliance with his PRN contract, his application shall be denied. In the event he has passed all of these tests and remained in compliance, he shall be granted a registration, subject to the following conditions which are supported by the record. --------------------------------------------------------------------------- \9\ Respondent shall provide this evidence to the Office of the Administrator no later than thirty (30) days from the date of this Order. Respondent shall also provide a copy of his filing to Government counsel. In the event Respondent fails to comply, his application will be denied. --------------------------------------------------------------------------- First, the Government notes that Respondent can walk away from his PRN contract at any time. While there is evidence that in the event Respondent were to do so, the PRN would report him to the DOH, the record does not establish what action the DOH would take in response. Accordingly, I conclude that Respondent's registration shall be conditioned on his remaining in compliance with his PRN contract. In the event Respondent fails to comply with his PRN contract, his registration shall be subject to an Immediate Suspension Order. Second, while Respondent's PRN contract expires in May 2016, Dr. Ziegler noted that PRN offers its clients a licensure-long contract. Moreover, in his testimony Respondent acknowledged that his recovery will be ``a lifelong struggle'' and expressed a willingness to enter into a licensure-long contract; he also acknowledged that DEA could require that he stay in the PRN program. Accordingly, I conclude that Respondent's registration shall be conditioned on his entering into a licensure-long contract upon the completion of his initial five-year contract. Moreover, if, following the completion of his initial five- year contract, Respondent fails to enter into a licensure-long contract, his [[Page 53203]] registration shall be subject to an Immediate Suspension Order. Third, Respondent may not accept any position as a physician without first obtaining approval of the PRN program. Respondent's acceptance of a position without first obtaining the PRN's approval shall subject his registration to suspension or revocation. Fourth, Respondent shall enter into an agreement with the PRN pursuant to which he authorizes and directs the PRN to report the results of any drug test he fails to the nearest DEA Field Division Office; a copy of this agreement must be provided to the DEA Field Division Office prior to the issuance of the registration. In the event Respondent is ordered to undergo a drug test and fails to comply in accordance with the PRN's rules, this shall be deemed a failed test. In the event Respondent fails any drug test, his registration shall be subject to an Immediate Suspension Order. Respondent is prohibited from possessing any controlled substances except for those he obtains pursuant to a lawful prescription or which are lawfully dispensed to him by a duly authorized health care provider. Respondent shall not order any controlled substances, nor accept any controlled substances (including manufacturer's samples) from any person (other than those which are lawfully dispensed to him), including a manufacturer's or distributor's sales representative. Moreover, Respondent shall not be authorized to administer controlled substances to any person until such time as PRN approves such activity; upon such approval, Respondent shall be authorized to possess such controlled substances. In the event Respondent violates the provisions of this paragraph, his registration shall be subject to an Immediate Suspension Order. If PRN approves Respondent to engage in the administration of controlled substances, Respondent shall provide a copy of a letter from PRN to this effect to the nearest DEA Field Division Office prior to engaging in such activity. ORDER Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Abbas E. Sina, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, held in abeyance pending his submission of all drug test results since January 28, 2014. I further order that in the event Respondent has passed all drug tests since January 28, 2014 and remained in compliance with his PRN contract, his application shall be granted subject to the conditions set forth above. I further order that in the event Respondent has not passed all drug tests since January 28, 2014 or other remained in compliance with his PRN contract, or fails to submit this evidence within the time set forth above, his application shall be denied. This Order is effective immediately. Date: May 15, 2015 Michele M. Leonhart, Administrator. [FR Doc. 2015-21732 Filed 9-1-15; 8:45 am] BILLING CODE 4410-09-P
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BURDEN TABLE—Continued
Non-hour cost burdens *
Average
Citation 30 CFR 250 Reporting and recordkeeping number of
Subpart B and NTLs requirement * Hour burden annual Burden hours
responses
annual
288; 289 .................... Submit a Conceptual Plan for approval ..................................... 375 8 plans ................ 3,000
294 ............................. Submit a combined Conceptual Plan/DWOP for approval be- 748 27 plans .............. 20,196
fore deadline for submitting Conceptual Plan.
295 ............................. Submit a revised Conceptual Plan or DWOP for approval with- 180 7 plan revisions ... 1,260
in 60-day of material change.
Subtotal .............. .................................................................................................... ........................ 53 responses ...... 36,996
$39,589 non-hour costs
200 thru 295 .............. General departure and alternative compliance requests not 8 11 requests ......... 88
specifically covered elsewhere in subpart B regulations.
Subtotal .............. .................................................................................................... ........................ 11 responses ...... 88
Total Burden ................................................................................................ 399 responses .... 37,084
$39,589 Non-Hour Cost Burdens
Estimated Reporting and Control Number for the information DEPARTMENT OF JUSTICE
Recordkeeping Non-Hour Cost Burden: collection requirements imposed by the
We have identified one non-hour cost 30 CFR part 250, subpart B regulations. Drug Enforcement Administration
associated with this IC; DWOP’s The regulation also informs the public [Docket No. 14–6]
($3,599) under § 250.292, and estimate that they may comment at any time on
that the annual total non-hour cost the collections of information and Abbas E. Sina, M.D.; Decision and
burden is $39,589. We have not provides the address to which they Order
identified any other non-hour cost should send comments. We received
burdens associated with this collection one comment in response to the Federal On May 15, 2015, the then-
of information. Register notice. The comment from a Administrator of the Drug Enforcement
Public Disclosure Statement: The PRA private citizen pertained to why weren’t Administration issued the attached
plans submitted electronically thereby order. Therein, based on her review of
(44 U.S.C. 3501, et seq.,) provides that
reducing the paperwork burden and the record, the then-Administrator
an agency may not conduct or sponsor
would also assist in retention of such concluded that, in the event Respondent
a collection of information unless it
plans. BSEE’s response: Since the split, presented evidence that he has
displays a currently valid OMB control
some plans have been transferred to continued to comply with his
number. Until OMB approves a
BOEM under 30 CFR part 550 and some Professionals Resource Network (PRN)
collection of information, you are not
to BSEE. As to the plans that are contract and has passed all drug tests
obligated to respond.
submitted to BSEE, we are developing since the closing of the record, he is
Comments: Section 3506(c)(2)(A) of entitled to be registered subject to the
the PRA (44 U.S.C. 3501, et seq.,) requirements for a new ePlans and
ePermits (electronic submittal) project extensive conditions set forth in her
requires each agency ‘‘. . . to provide order. The then-Administrator thus
notice . . . and otherwise consult with that does include Deepwater Operations
Plans (DWOPs) that should start in ordered Respondent to provide such
members of the public and affected evidence.
agencies concerning each proposed development by FY 2016.
Public Availability of Comments: In response to the order, Respondent
collection of information . . .’’ Agencies provided his drug test results, all of
must specifically solicit comments to: Before including your address, phone
number, email address, or other which have been negative. Respondent
(a) Evaluate whether the collection is did not, however, provide evidence of
necessary or useful; (b) evaluate the personal identifying information in your
comment, you should be aware that his compliance with the other terms of
accuracy of the burden of the proposed his PRN contract. Accordingly, on July
collection of information; (c) enhance your entire comment—including your
personal identifying information—may 27, 2015, I issued an order directing
the quality, usefulness, and clarity of Respondent to ‘‘provide a sworn letter
be made publicly available at any time.
the information to be collected; and (d) from the PRN attesting to his continued
While you can ask us in your comment
minimize the burden on the compliance with his PRN contract.’’
to withhold your personal identifying
respondents, including the use of Order of the Administrator, at 1 (July 27,
information from public review, we
technology. 2015).
cannot guarantee that we will be able to
mstockstill on DSK4VPTVN1PROD with NOTICES
To comply with the public Respondent has now complied and
do so.
consultation process, on May 22, 2015, submitted a notarized letter from
we published a Federal Register notice Dated: August 5, 2015. Penelope P. Ziegler, M.D., the PRN’s
(80 FR 29736) announcing that we Robert W. Middleton, Medical Director, attesting that he has
would submit this ICR to OMB for Deputy Chief, Office of Offshore Regulatory remained fully compliant with his PRN
approval. The notice provided the Programs. contract. I therefore conclude that
required 60-day comment period. In [FR Doc. 2015–21725 Filed 9–1–15; 8:45 am] Respondent has met the requirements
addition, § 250.199 provides the OMB BILLING CODE 4310–VH–P for obtaining a new registration as set
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![53192 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices
forth in the May 15, 2015 order (which 23, 2005, Respondent had written and his studying to become board
is attached and incorporated as the eleven prescriptions for OxyContin certified in addiction medicine. R.D. at
Decision in this matter), and that he is 80mg, which authorized the dispensing 36–37.
entitled to be registered subject to the of 720 dosage units, ‘‘without However, the ALJ further explained
conditions set forth therein. establishing a valid doctor-patient that ‘‘while he was buying heroin and
relationship,’’ and that ‘‘a medical other drugs on the street, [Respondent]
Order has become very well acquainted with
expert who reviewed [his] actions
Pursuant to the authority vested in me concluded that [the] prescriptions . . . those in the community who have
by 21 U.S.C. 823(f) and 28 CFR 0.100(b), were for other than a legitimate medical chosen to traffic in heroin’’ and that ‘‘[a]
I order that the application of Abbas E. purpose and outside the usual course of person with that kind of experience,
Sina, M.D., for a DEA Certificate of professional practice.’’ Id. at 2 (citing 21 particularly one authorized to write
Registration as a practitioner be, and it U.S.C. 841(a)(1); 21 CFR 1306.04(a)). prescriptions for narcotics and other
hereby is, granted, subject to the The Order further alleged that the controlled substances, holds a highly
conditions set forth in the then- Florida Board of Medicine had valuable key recognized by those in our
Administrator’s Order of May 15, 2015. instituted a proceeding against him society who are likely to try to exploit
This Order is effective immediately. based on his misconduct but that he had that authority to advance their own
Dated: August 26, 2015. been ‘‘allowed to settle the case without illicit goals.’’ Id. at 37. Continuing, the
Chuck Rosenberg, admitting to the underlying ALJ reasoned that restoring
Acting Administrator. allegations.’’ Id. Respondent’s ‘‘ability to prescribe
Anthony Yim, Esq., for the Government. The Show Cause Order further alleged controlled substances carries with it
William W. Tison, III, Esq., for the that during his September 2012 some risk, given the unique skill set [he]
Respondent. interview, Respondent admitted that he developed while seeking heroin and
had again begun ‘‘abusing heroin in late other drugs on the street.’’ Id. at 38. The
ORDER OF THE ADMINISTRATOR 2009/early2010,’’ and that his use of ALJ then reasoned that while
May 15, 2015 heroin had tripled over the course of Respondent ‘‘may well be able to resist
On November 12, 2013, the Deputy several months. Id. The Order then efforts from those in the trafficking trade
Assistant Administrator, Office of alleged that during the interview, to recruit him during periods of
Diversion Control, issued an Order to Respondent admitted that ‘‘on or about sustained stable recovery, were he to
Show Cause to Abbas E. Sina, M.D. February 4, 2011,’’ he had been arrested relapse those illicit efforts may well
(hereinafter, Respondent), of St. Pete at Tampa International Airport and prove successful, creating a significant
Beach, Florida. ALJ Ex. 1, at 1. The charged with possession of heroin with risk of prescription drug diversion.’’ Id.
Show Cause Order proposed the denial intent to distribute; possession of The ALJ thus concluded that ‘‘Factor
of Respondent’s application for a DEA methadone, a schedule II drug; Two neither supports nor contradicts
Certificate of Registration as a possession of Xanax, a schedule IV granting [his] application.’’ Id.
practitioner, on the ground that his drug; possession of drug paraphernalia; As for Factor Four—compliance with
‘‘registration would be inconsistent with and trafficking in illegal drugs. Id. The applicable laws related to controlled
the public interest, as that term is Order also alleged that Respondent was substances—the ALJ noted that
defined in 21 U.S.C. 823(f).’’ Id. allowed to resolve the charges by Respondent had conceded that the
As jurisdictional facts, the Show entering a pre-trial diversion program. Government had established a prima
Cause Order alleged that Respondent Id. facie case to deny his application. Id.
had previously held a DEA Certificate of Respondent timely requested a The ALJ then noted that Respondent
Registration which he surrendered ‘‘for hearing on the allegations. ALJ Exs. 2 & had unlawfully possessed heroin and
cause on July 13, 2011,’’ id. at 2, and 3. The matter was placed on the docket drug paraphernalia in 2003; that he had
that on July 13, 2012, he had applied for of the Office of Administrative Law unlawfully prescribed 720 dosage units
a new practitioner’s registration seeking Judges, and assigned to Administrative of OxyContin to his girlfriend, which he
authority to dispense controlled Law Judge (ALJ) McNeil who, following then diverted for his own use; that he
substances in schedules II through V. Id. pre-hearing procedures, conducted an had misled state authorities ‘‘by
at 1. The Order then alleged that during evidentiary hearing in Clearwater, withholding from them the fact that he
an interview with a DEA Investigator Florida on March 4–5, 2014. Following was diverting the [drugs] for his own
regarding his application, Respondent the hearing, both parties filed briefs use’’; and that in 2011, he unlawfully
admitted to a history of abusing containing their proposed findings of possessed heroin, methadone, and
controlled substances including heroin. fact, conclusions of law, and Xanax, as well as drug paraphernalia.
Id. recommended order. Id. at 39. The ALJ thus concluded that
More specifically, the Show Cause On May 7, 2014, the ALJ issued his the evidence with respect to Factor Four
Order alleged that Respondent admitted Recommended Decision. Therein, the provided ‘‘a legally sufficient basis’’ to
that ‘‘[o]n or about February 26, 2003,’’ ALJ found that the Government had deny his application. Id.
he had ‘‘purchased heroin from street established a prima facie case to deny As for Factor Five—such other
dealers’’ and ‘‘overdosed,’’ after which Respondent’s application. With respect conduct which may threaten public
he was arrested and charged with to Factor Two—Respondent’s health and safety—the ALJ noted that
possessing heroin, possessing drug experience in dispensing controlled Respondent’s self-abuse of controlled
paraphernalia, and driving under the substances—the ALJ noted that substances itself supports denying his
mstockstill on DSK4VPTVN1PROD with NOTICES
influence. Id. The Order then alleged Respondent had ‘‘significant positive application. Id. at 40. The ALJ further
that Respondent was allowed to resolve training and credentials relating to noted that independent of the evidence
the charges by entering a pre-trial prescribing controlled substances,’’ of his abuse of controlled substances,
diversion program, but that in 2004, he which included his training as a the evidence showed that during his
had again begun to abuse controlled medical resident, his twenty-three years periods of abuse, he ‘‘has a
substances. Id. at 1–2. as an emergency room physician, his demonstrated tendency towards lying in
Next, the Show Cause Order alleged completion of a course in the proper the course of responding to
that between June 19, 2004 and March prescribing of controlled substances, governmental processes.’’ Id. The ALJ
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![Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices 53193
also suggested that Respondent had numbers one (1) through eight (8) FINDINGS OF FACT
given false testimony in this proceeding (apparently as set forth in the Respondent’s Licensure and
when he testified that the report of a Supplemental Prehearing Statement) Registration Status
physician, who had reviewed the and Respondent’s Proposed Stipulations
investigative file prepared by a Florida one (1) through four (4). The parties Respondent is a medical doctor
DOH investigator for the DOH, was ‘‘100 licensed by the Florida Board of
further stated that they did not agree to
percent accurate’’ because it ‘‘made no Medicine. RX A. Respondent, who has
Respondent’s Proposed Stipulations five
mention of the whole truth,’’ that being been licensed for nearly thirty years, is
(5) through twenty-four (24). board certified in internal medicine. Id.
that Respondent was diverting the drugs
for his own use. Id. Thereafter, the record was forwarded Following his residency, Respondent
However, the ALJ then noted that to this Office for final agency action. practiced as an emergency room
Respondent does not currently present[ ] Having considered the entire record, I physician for more than twenty years.
a threat to the public due to a agree with the ALJ’s conclusion that the Id.
predisposition to prevaricate’’ and that Government has satisfied its prima facie Respondent previously held a DEA
he ‘‘can be relied upon to be forthright burden of showing that Respondent’s Certificate of Registration, pursuant to
and candid during his recovery.’’ Id. at registration would be inconsistent with which he was authorized to dispense
41. The ALJ further noted that he ‘‘was the public interest. R.D. 49. However, in controlled substances in schedules II
impressed with [Respondent’s] the event Respondent has continued to through V as a practitioner. See GX 2,
demeanor, his expressions of regret and remain in compliance with his PRN at 3. However, on July 13, 2011,
apology, and with his determination to contract and has passed all of his drug Respondent surrendered this
succeed in his recovery.’’ Id. The ALJ tests since January 28, 2014 and registration for cause. See GX 3. On July
nonetheless concluded that produces such evidence within thirty 12, 2012, Respondent applied for a new
Respondent’s ‘‘chronic history of (30) days of the date of this Order, I practitioner’s registration, seeking
substance abuse’’ and ‘‘pattern of conclude that he will have produced authority to dispense controlled
misleading governmental officials’’ sufficient evidence to rebut the substances in schedules II through V.
created ‘‘an unacceptably strong Government’s prima facie case. Id. at 50. See GX 1; GX 2, at 1–2. It is this
likelihood that [he] would revert to his I make the following findings.1 application which is at issue in the
past behavior and would attempt to proceeding.
either self-medicate or self-destruct’’ 1 Because the parties jointly agree that the
Respondent’s History of Substance
and thus provided a ‘‘legally sufficient Government never agreed to Respondent’s proposed Abuse
and independent basis’’ to deny his stipulations numbers five (5) through twenty-four
application. Id. (24), I do not consider those stipulations as proving While Respondent has practiced
Addressing the evidence of their factual assertions. However, having read the medicine for nearly thirty years
relevant portion of the transcript, I do not find the
remediation, the ALJ found that the Government’s argument well taken, and but for the
(including his residency), in his
record as a whole supported the fact that Respondent agreed that the Government testimony he admitted to a long history
conclusion that Respondent has had not agreed to the stipulations, I would have of abusing alcohol and controlled
accepted responsibility for his rejected the Government’s contention. substances. Indeed, he admitted to using
According to the transcript, the following alcohol; prescription controlled
misconduct. Id. at 42. However, based colloquy occurred:
on the testimony of two of Respondent’s ALJ: Okay. All those stipulations are now
substances without a prescription; as
witnesses, the ALJ concluded that considered as facts that I will use in the analysis well as street drugs including
Respondent’s ‘‘risk of relapse remains and recommendations that I prepare in this case. marijuana, heroin, cocaine, Ecstasy, and
high, and will continue to be high . . . ALJ: [Government Counsel], the Government was LSD. Tr. 194. Indeed, when asked what
throughout the five years following the able to stipulate to the four facts shown in my order drugs he had used beside alcohol,
of January 28, 2014, but it was not able to stipulate
commencement of his recovery’’ and to the remainder of those stipulations proposed by prescription drugs, and heroin, he
‘‘that insufficient time in stable recovery the Respondent. Those appear in the Respondent’s replied that ‘‘[i]t would be easier to say
has passed to support a finding that initial prehearing statement. Do you have that that I think there’s three drugs that I
corrective action has been taken.’’ Id. statement? haven’t used in my lifetime.’’ Id. at 193.
[Government Counsel]: I do your honor. Respondent admitted to using alcohol
While acknowledging that ‘‘steps that
ALJ: Are there any proposed stipulations there for
may lead to effective corrective action which the Government cannot agree?
and marijuana beginning at the age of
have begun, . . . those steps are not Government Counsel: No, your honor. fourteen. Id. at 194. Moreover, while
complete, and in the absence of Tr. 45–46. The Government contends that the ALJ Respondent testified that he ‘‘stopped
complete corrective action the ‘‘erred’’ in ‘‘interpret[ing] this colloquy as the after some bad things happen[ed] to
Respondent has not, by a Government’s agreement to stipulate to the nineteen friends’’ and that he ‘‘lost the desire to
stipulations to which it had previously declined to
preponderance, presented evidence that agree in writing.’’ Gov. Exceptions, at 5. This
do that around college time and medical
would permit the restoration of his’’ argument, however, begs the question of why the school,’’ he began drinking a ‘‘few years
registration. Id. at 42–43. The ALJ thus ALJ would ask the Government if it was stipulating into’’ his practice as an emergency room
recommended that Respondent’s to the same four stipulations which it had already physician. Id. at 195.
agreed to during the conference held by the ALJ on Moreover, Respondent admitted that
application be denied. January 28, 2014. See Tr. 13. (ALJ: ‘‘Are there any
Thereafter, the parties filed a Joint of those that you agree can be considered as fact?’’ beginning in 1998, he began abusing
Statement Regarding the Proposed Government Counsel: ‘‘Stipulations 1 through 4, Vicoprofen (a controlled substance
Stipulations. However, only the your honor.’’ ALJ: ‘‘1 through 4 are admitted as which contains hydrocodone) samples
evidence without further evidence being required to
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Government filed Exceptions to the that he received. Id. at 192. Moreover,
establish those as fact then.’’).
Recommended Decision. I find that the ALJ’s question was clear enough
Respondent testified that because he
As for the Joint Statement Regarding to put the Government on notice that he was asking had back problems, he had previously
the Proposed Stipulations, therein, the about those stipulations offered by Respondent obtained some oxycodone ‘‘from a
parties averred that ‘‘it was their which the Government had not previously agreed friend who finished his prescription,’’
to. To extent the Government was unclear as to
impression and understanding that’’ which stipulations the ALJ was asking it about, it
and that on September 11, 2001, he
they had agreed only to the was incumbent on the Government to clarify which ‘‘woke up and the whole world seemed
Government’s Proposed Stipulations stipulations it had agreed to. like it was coming to an end’’ so he
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injected himself with the oxycodone. Id. Thereafter, Respondent was pharmacy had filled had been written
at 198. According to Respondent, ‘‘it criminally charged with possession of on the prescriptions of the hospital
was a very stressful situation that I heroin. ALJ Ex. 16 (Gov. Stipulation #5). where he worked. Id.
responded very poorly to by turning to However, Respondent was offered a After determining that Respondent
something that I would never have [and pretrial drug intervention program, had not treated B.B. at the hospital
had] never done before and didn’t see which he successfully completed and where he worked, a DOH Investigator
the significance of that action.’’ Id. the charges were nolle prossed. Id.; Tr. obtained the original prescriptions. The
However, the oxycodone ‘‘didn’t work 231. prescriptions showed that between June
because I didn’t get it in right and I According to Respondent, as part of 19, 2004 and March 23, 2005,
didn’t feel anything.’’ Id. the program he was required to undergo Respondent had issued B.B. eleven
As for his abuse of heroin, an evaluation; however, he told the prescriptions for OxyContin 80mg,
Respondent testified that in 2003, he evaluator that the drugs were not his but which authorized the dispensing of 720
encountered J.R., his ex-wife’s former J.R.’s, and that he had remained in a dosage units. GX 11, at 11–19.
boyfriend, at a bar. Id. at 197. According nightclub while J.R. had gone out to the Consistent with pharmacist’s report, the
to Respondent, his ex-wife had car and used the drugs. Tr. 200. As part quantity of the dispensings increased
previously told him to stay away from of the program, he also was required to from approximately 60 to 120 dosage
J.R. because he did heroin. Id. However, pass drug tests over the course of a six- units per month. Id. at 12.
because he ‘‘got curious and wanted to month period. Id.; see also id. at 231. Thereafter, the DOH Investigator,
try it,’’ Respondent apparently Regarding his false statement to the accompanied by a Detective with the
approached J.R., who told him that ‘‘he evaluator, Respondent testified that Pinellas County Sheriff’s Office, went to
knew where he could get it [heroin] in ‘‘unfortunately—this was an Respondent’s residence where they
Tampa, and if I was to buy [J.R.’s], he opportunity for me to change . . . to fix interviewed both Respondent and B.B.
would . . . make the purchase.’’ Id. the problem, and I don’t blame anybody Id. at 3. B.B. told the Investigators that
but me because I’m the one who she was Respondent’s fiancé and lived
Respondent drove J.R. to Tampa, and
weaseled out of it.’’ Id.; see also id. at with him. Id. at 4. She also told the
after J.R. procured the heroin, both he
230 (‘‘Now I look at that as an Investigators that she had injured her
and J.R. injected themselves with heroin
opportunity to change my life, and I neck in a car accident seven years
while in Respondent’s car. Id.
blame no one but myself for not giving earlier and had reinjured it during the
Subsequently, the police were called to
the real information to the previous year while on a ski trip. Id. She
a location in Tampa where they found
counselor. . . .’’). further told the Investigators that she
Respondent and J.R. in the former’s
Respondent further testified that at did not seek treatment at the time of the
vehicle, which was parked with three the time, he did not think he was an injury because Respondent ‘‘took over
wheels over the curb and one wheel on addict, although he ‘‘really was,’’ her’’ treatment, but that he ‘‘did not do
the road. GX 4, at 7. Respondent was in because he had not become physically any diagnostic studies of her neck’’ nor
the driver’s seat, with his eyes open, but dependent on heroin and did not go ‘‘refer her to a specialist.’’ Id. Instead,
was unresponsive when a police officer through withdrawal. Id. However, he ‘‘he just prescribed OxyContin for
knocked on the window and shined his then explained that he was both pain.’’ Id.
flashlight onto Respondent’s face. Id. ‘‘emotionally’’ and ‘‘psychologically During his interview, Respondent
Initially, Respondent was motionless, dependent’’ on the drug. Id. According stated that he was an ER physician at a
but he then began to shake every ten to Respondent, while he ‘‘knew there local hospital and that he ‘‘did not have
seconds. Id. After a short period, J.R. was a problem, [he] thought [he] could an outside practice.’’ Id. He admitted to
came to and a police officer removed handle that problem, and that was the writing the prescriptions and
him from Respondent’s car and placed biggest problem of it all.’’ Id. at 231. corroborated B.B.’s statement that she
him in his patrol car. Id. The officer As Respondent further testified, had reinjured her neck when they were
then returned to Respondent’s car and ‘‘that’s a big problem among physicians on ski trip. Id. Respondent also
observed a Tampa Fire Department unit because we’re supposed to be the ones eventually admitted that he did not
giving aid to Respondent (which that fix people. And so if we can’t fix have any medical records for his
included the administration of Narcan) ourselves, we have to admit to ourselves treatment of B.B., that he had not done
and removing him from his car. Id. at 7– that we are not capable of fixing other a diagnostic workup, and that he had
8. From outside Respondent’s car, the people either. And that’s a pride issue.’’ not referred her to a specialist. Id. He
officer saw a metal spoon, which Id. then stated that he intended to refer B.B.
contained a brown substance, on the The evidence further shows that in to a specialist, but had yet to do so. Id.
floor behind the driver’s seat. Id. at 7. March 2005, a pharmacist contacted the Subsequently, the DOH retained a
The officer seized the spoon and field DOH and reported that over a period of medical expert who reviewed its
tested the brown substance, which several months, she had received investigative file. GX 8. The expert
tested positive for heroin. Id. The Office prescriptions written by Respondent to concluded that Respondent’s ‘‘care fell
also found an Altoids can on the B.B. for steadily increasing dosages of well below the standard of care as
dashboard in front of the driver’s seat; OxyContin 80mg, including a recent defined by Floirda[sic] state, local and
the can held two Q-tip swabs in a small prescription for 120 dosage units for national norms,’’ that OxyContin is ‘‘a
zip-lock bag, a cotton ball, and an which B.B. paid $1,172.99 in cash. GX strong and highly addictive medication’’
alcohol wipe. Id. 11, at 3. The pharmacist also reported which ‘‘requires careful diagnosis and
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Another police officer conducted a that Respondent was an emergency regular reassessment of the patient,’’
DUI investigation of Respondent which room physician and yet he had been and that ‘‘[i]t is unacceptable to
resulted in his arrest. Id. Thereafter, writing the prescriptions on blanks that prescribe the medicine without
Respondent’s vehicle was impounded listed his home address and cell phone adequate examination and
and an inventory search was conducted; number. Id. The pharmacist also documentation.’’ Id. at 2. The expert
the search found numerous syringes and reported that she had run a physician further noted that Respondent did not
a vial of sterile water in the vehicle’s profile on Respondent and found that maintain any medical records on B.B.,
console. Id. all of the other prescriptions that the that there was ‘‘no evidence that
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[Respondent] assessed the patient’s I was scared into stopping the use of any— Id. at 215. However, after three days of
medical problems’’ and there were ‘‘no doing anything wrong for almost a year after withdrawal his symptoms became
known x-rays, lab tests or evaluations.’’ that. But unfortunately I never—because I unbearable, so he decided to go and
Id. The expert thus concluded that lied—I may as well—I lied about using the ‘‘bought a whole bunch [of] heroin and
medicines that I prescribed to her myself.
Respondent’s ‘‘diagnosis was therefore Well, I didn’t lie. I just never said anything.
got as much methadone as [he] could.’’
inappropriate and inadequate.’’ Id. Nobody asked. Nobody from the Department Id.
The expert further concluded that of Health asked, and I didn’t volunteer that On February 4, 2011, Respondent
while ‘‘[a] specialist’s care was not information. And unfortunately, as far as I’m attempted to leave on the trip. Tr. 84.
absolutely essential for such a patient’’ concerned, it’s a lie, and that lie got me no However, upon going through security
and that an ‘‘internist could care for treatment and no help. And to this day—first at the airport, Respondent was observed
such a patient under different of all, if I would have said something the first ‘‘sweating profusely and shaking’’ and
circumstances,’’ Respondent committed time with the heroin thing to PRN, my whole was found to be ‘‘in possession of a
an ‘‘egregious error’’ by prescribing life would be different.
controlled substance without a
OxyContin to ‘‘an intimate partner . . . Id. at 204. prescription.’’ Id. Respondent was
over a prolonged period.’’ Id. He also arrested, and during the search of his
Respondent further explained that he
noted that ‘‘[n]o obvious plan for long person, the police found 34 bags of
and his girlfriend, who had a ‘‘bad neck
term treatment was identified.’’ Id. He heroin. Id. at 85. Respondent admitted
thus opined that Respondent’s to begin with,’’ were on a one-week long
ski-trip in Colorado, and that on the first to the police that the bags contained
prescribing ‘‘was strikingly heroin; a subsequent analysis by a
inappropriate.’’ Id. day, she had ‘‘wiped out on a
snowboard’’ and ‘‘couldn’t move,’’ so he Florida Department of Law Enforcement
Thereafter, the DOH issued an lab confirmed this. Id. at 85–86. At the
administrative complaint to called in a prescription for
hydrocodone. Id. at 205. Respondent time of his arrest, the police also
Respondent. The complaint charged retrieved his checked bags from the
Respondent with: 1) failing to practice was not sure if he had taken any of the
hydrocodone, but believed that he had airline, and upon searching them,
medicine with that level of care, skill, discovered twelve syringes. Id. at 85.
and treatment of ‘‘a reasonably prudent not because the prescription was for a
small quantity which his girlfriend Respondent stipulated that at the time
similar physician . . . under similar
needed to get through the trip. Id. at of his arrest, he ‘‘was also in possession
conditions and circumstances’’; 2)
205–06. However, upon returning to of’’ thirty-seven tablets of methadone
prescribing ‘‘a legend drug, including
Florida, Respondent began prescribing 10mg and three tablets of Xanax 2mg,
any controlled substance, other than in
oxycodone, and Respondent admitted and that he did not have a prescription
the course of the physician’s
that by the second prescription, he was for either drug. ALJ Ex. 16, at 2 (Gov.
professional practice’’; and 3) failing to
‘‘definitely’’ using her oxycodone. Id. at Stipulations #9); see also RX C, at 1.
keep medical records justifying the
course of treatment. GX 5, at 15–16, 18. 205. Respondent further admitted that While Respondent was again
Respondent was allowed to enter into he had changed her prescription to criminally charged, the charges were
a settlement agreement with the DOH, oxycodone because ‘‘if she had them I eventually nolle prossed as well. Tr. 79.
pursuant to which he was not required might be able to get to them.’’ Id. at 207. However, in contrast to the two
to admit the facts of the Administrative Respondent maintained that after the previous episodes, Respondent sought
Complaint, but did admit that if those visit from the DOH and the Detective, he the assistance of the Professional
facts were proved, they would establish stopped using the drugs but developed Resource Network (hereinafter, PRN), an
violations of Florida law as alleged in ‘‘physical withdrawal symptoms.’’ Id. at entity under contract with the DOH to
the Complaint. GX 5, at 4. The DOH 208. He then started drinking to deal provide assistance to ‘‘licensed
then reprimanded Respondent; fined with the stresses in his life. Id. at 209. professionals . . . who are experiencing
him $15,000; required that he reimburse Sometime around 2009 or 2010, difficulties due to some form of
the DOH’s costs in an amount up to Respondent was involved in a lawsuit impairing illness.’’ Id. at 298.
$2,000; required that he perform 100 and began injecting heroin again. Id. at Respondent was referred to a treatment
hours of community service; and 210. Because his use of heroin caused program (Health Care Connection)
required that he take a course on withdrawal symptoms, he also used which is run by Dr. David Myers, a
‘‘Prescribing Abusable Drugs.’’ Id. at methadone, which he obtained from his Certified Addiction Professional who is
4–7. heroin supplier, to counteract those both a Diplomate of the America Board
Regarding these events, Respondent symptoms. Id. at 211. However, because of Addiction Medicine and a Fellow of
admitted that the facts alleged in the his use of heroin was intermittent, it the American Society of Addiction
DOH’s complaint ‘‘are the facts,’’ that disturbed his sleep. Id. at 212–13. Medicine. Id. at 104; RX E. Dr. Myers
his prescribings to B.B. were outside the Respondent testified that he would testified that he has twenty-five years of
usual course of professional practice, occasionally use Xanax, which he took experience ‘‘working with chemically
and that he ‘‘did not’’ have a proper from his girlfriend’s prescription. Id. at dependent people,’’ and that ‘‘for the
medical justification to prescribe to B.B. 213. last twenty years,’’ his focus has been
Tr. 201–03. He also testified that he Eventually, Respondent’s use of ‘‘on recovering professionals.’’ Tr. 97.
‘‘[a]bsolutely’’ agreed with the heroin escalated into daily use and the Dr. Myers testified that his program
conclusions contained in the DOH dose needed to avoid becoming sick has been recognized as a PRN compliant
Expert’s report. Id. at 203. When then ‘‘would pretty much double every two program. Id. at 101. His program
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asked: ‘‘Is there any part of this report or three days.’’ Id. at 213–14. evaluates new patients, detoxes and
you do not agree with,’’ Respondent Respondent tried to stop twice by going stabilizes them, and ‘‘begin[s] to
answered: ‘‘No. It’s 100 percent ‘‘cold turkey,’’ including once prior to a introduce them into recovery techniques
accurate.’’ Id. scheduled ski trip, when he had and whatever therapy they may need.’’
When asked whether the episode had arranged to have two weeks off from Id. at 102. According to Dr. Myers, a
scared him straight or whether he had work. Id. at 214. Respondent testified new patient receives an extensive
continued to abuse narcotics, that he had planned on telling his interview and is subject to either a drug
Respondent testified: friends that he couldn’t go on the trip. screen or a hair screen after which a
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treatment recommendation is made. Id. profile in my county.’’ Id. at 133. Dr. who participated in the same recovery
at 105–06. Myers then stated that he ‘‘considers group as Respondent, id. at 159–62,
On February 12th (eight days after his [Respondent] safe or [he] wouldn’t have testified that Respondent has been ‘‘very
arrest), Respondent entered Dr. Myers’ him.’’ Id. open and honest about his addiction as
program and underwent an initial Dr. Myers also testified that he well as his recovery’’ and that ‘‘he
assessment. According to Dr. Myers, expects Respondent to continue to do definitely has an interest in helping
Respondent ‘‘was very transparent,’’ well and that he is fully committed to others who are afflicted with the same
‘‘did not make any attempts to muddy his recovery. Id. at 132. While Dr. Myers disease.’’ Id. at 163. Still another
the water,’’ and told him ‘‘exactly what acknowledged that Respondent will physician, who has worked with and
happened.’’ Id. at 117. A drug test never be cured, he expressed his belief supervised Respondent at Health Care
confirmed Respondent’s story regarding that Respondent ‘‘is making it’’ and will Connection testified that he had not
the drugs he had been abusing. Id. at ‘‘continue to make it.’’ Id. Dr. Myers also observed Respondent engage in any
110. His treatment included testified that Respondent had started a conduct demonstrating that he is not ‘‘a
detoxification, followed by 60 days of new group for recovering doctors in safe and responsible’’ physician and
partial hospitalization which included Pinellas County. Id. at 149 & 161. that Respondent is ‘‘passionate about’’
group therapy, and then entry into a On cross-examination, Dr. Myers his recovery. Id. at 182–83.
halfway house. Id. at 119–21. acknowledged that he could not Respondent also called as a witness,
Respondent passed all of his drug tests, guarantee that Respondent would not Dr. Penelope Ziegler, the Medical
and according to Dr. Myers ‘‘did very relapse. Id. at 142. However, when Director and CEO of PRN, Inc. Id. at 298.
well.’’ Id. at 122–23. asked if there is a correlation between Dr. Ziegler is board certified in
On May 18, 2011, Respondent entered the length of a person’s abuse and the Psychiatry and Addiction Psychiatry, as
into a contract with the PRN for a period likelihood of relapse, Dr. Myers testified well as certified in Addiction Medicine
of five years. RX B, at 6. Pursuant to the that while ‘‘[t]here are a number of by the American Board of Addiction
contract, Respondent agreed, inter alia, factors which can help predict Medicine. Id. at 299. Since the
to participate in random drug testing relapses,’’ he did not believe that a completion of her residency in 1982, Dr.
‘‘within twelve hours of notification’’; to correlation has been established Ziegler has ‘‘focused [her] professional
abstain completely from the use of any between the length of use and the activities on the treatment of addiction’’
medications, alcohol or other mood likelihood of relapse. Id. Notably, the as well as ‘‘other psychiatric disorders.’’
altering substances unless prescribed by Government put forward no evidence to Id. Prior to her present positions, she
his physician and to send copies of all refute Dr. Myers’s testimony on this was the medical director of similar
such prescriptions to the PRN; to attend point. programs in Pennsylvania and Virginia.
recovery group meetings three times per For reasons not entirely clear—given Id.
week; and to agree to attend a weekly that at the time of the hearing, After explaining the PRN’s program,
PRN monitored professional group with Respondent had been complying with Dr. Ziegler testified that Respondent
his monitoring professional. Id. at 2–3. his PRN contract for nearly three ‘‘has been entirely compliant with his
He also agreed to notify PRN of any years—the Government then asked Dr. contract and [that] we have received all
changes in his physical or mental Myers: of his reports as scheduled . . .
health, as well as any change of address indicating continued progress.’’ Id. at
Q. So you’re telling me that a person has
or employer; to provide releases for 306. She further testified that ‘‘all of
the same amount of percentage of relapsing
urine screen results, treatment center . . . [who] is drug tested weekly, [goes to] [Respondent’s] urine screens have been
records and therapist reports; to notify weekly community meetings, you think that negative,’’ and thus she believes that he
the PRN in the event of his use of that provided the same type relapse has not been using controlled
‘‘mood altering substances without a percentage as a person who is without any substances illegally. Id. Corroborating
prescription’’; to not hold a state supervision . . . at all? Dr. Ziegler’s testimony, Respondent
dispensing practitioner’s license; and to A. We know that it takes five years to reach submitted a Test History Report listing
withdraw from practice at PRN’s request maximum benefit in recovery, where the each drug test he had undergone
‘‘if any problem develops that relapse rates then become pretty consistent between June 6, 2011 and January 28,
potentially interferes with [his] over time, whether it’s five years or 10 years 2014; the report indicates that each test
or 15 years.
professional practice.’’ Id. at 3–4. was negative. RX D.
Dr. Myers further testified that Id. at 143. Dr. Myers then explained that Dr. Ziegler further testified that
Respondent works for him at Health this was based on ‘‘five years of Respondent’s contract is scheduled to
Care Connection and that he performs monitoring.’’ Id. at 144.2 end on May 18, 2016. Tr. 307. She then
histories and physicals, ‘‘helps with the Another physician, who is both a explained that PRN offers most doctors
detox regimens,’’ and helps with sick fellow staff member at Health Care the ‘‘opportunity to extend their
call. Tr. 124–25. Moreover, Dr. Myers Connection and a recovering physician monitoring beyond the five years if they
has used Respondent ‘‘to cover the choose,’’ and that if a doctor agrees to
detox unit at’’ the Agency for 2 The Government then asked Dr. Myers if he had
do so, they are given a contract for
Community Treatment Services, a non- ‘‘compared data for treated monitoring versus ‘‘extended monitoring.’’ Id. While this
untreated monitoring?’’ Tr. 144. While Dr. Myer
profit, public detoxification unit in replied that ‘‘[t]hat has been done, but only in the contract does not require continued
Tampa. Id. at 125. According to Dr. first two to three years of the recovery process,’’ id., attendance at group meetings, it still
Myers, Respondent ‘‘does a good job’’ the record does not establish what ‘‘untreated requires urine screening. Id. Dr. Ziegler
monitoring’’ involves.
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and has ‘‘learned how to share his also noted that in some cases, PRN
Subsequently, Dr. Myers testified that the PRN
recovery with other people who are had initially used ‘‘a two-year contract’’ but found
offers a physician a ‘‘licensure long
struggling in a way that is appropriate that ‘‘too many docs and . . . healthcare contract.’’ Id. at 308. Dr. Ziegler
and within a set of medical professionals [were] relapsing following the two explained that a ‘‘licensure long
boundaries.’’ Id. at 128. He further years.’’ Id. at 147. Dr. Myers then explained that the contract . . . is sometimes required by
PRN contract was lengthened ‘‘to five years, which
testified that if he had ‘‘any doubt that is what studies suggest . . . is a solid recovery
the Board of Medicine’’ where the Board
he was risky, I couldn’t use him’’ time’’ and that ‘‘the percentage of relapse is very believes that a physician is an ‘‘ongoing
because ‘‘[m]y practice is too high low’’ for those persons who complete five years. Id. risk of relapse without monitoring.’’ Id.
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However, a physician can voluntarily significance [she] attach[ed] to the come and testify that this person has done
request a licensure-long contract, which premise of a stable recovery [being] the right thing and is safe to practice and
remains in effect until the physician measured in terms of five years?’’ Id. at whatever. If that’s what you mean by
advocacy, yeah, that’s what we do, part of
retires, voluntarily relinquishes his 325. Dr. Ziegler answered: what we do.
license, or some ‘‘untoward Right now that is sort of a standard accepted And the other part of what we do is we
circumstances’’ arise. Id. at 309. practice in all of the professional monitoring withdraw advocacy if it’s no longer wanted
Dr. Ziegler testified that one of the programs that are members of a group called or warranted . . . because otherwise our
terms of Respondent’s PRN contract is the Federation of State Physician Health credibility is no good. . . . Our credibility
that he is required to obtain ‘‘permission Programs. depends upon our willingness to withdraw
from PRN to return to practice.’’ Id. at It used to be three years and it was our advocacy if the person no longer
310. She further testified that extended to five years because there was [sic] warrants that advocacy.
some research studies that showed that three Id. at 329–30.
Respondent has complied with each of
years may not be long enough and that
the conditions of the contract, as well as On further questioning by
relapses did frequently occur at the three-
all federal and state laws related to year point, although we don’t really fully Respondent’s counsel, Dr. Ziegler
controlled substances while he has been understand why because the research isn’t testified that it was ‘‘correct’’ that 85 to
in the PRN’s program. Id. at 311–12. there to demonstrate it. But that’s pretty 90 percent of PRN’s patients ‘‘comply
On cross-examination, Dr. Ziegler much a standard operating procedure for with their contract[s] and ‘‘make it.’’ Id.
acknowledged that Respondent could most of these monitoring programs around at 331. However, on re-cross
‘‘walk away from’’ his PRN contract at the country. examination, Dr. Ziegler acknowledged
any time if he chose to do so. Id. at 312. It definitely seems to correlate with that she could not guarantee that
outcome data that says the chances of relapse Respondent would never relapse. Id. at
However, she also explained that if he
after five years of stable monitored recovery
did so, he would be ‘‘immediately 331–32.
is greatly lessened compared to people who
reported’’ to the DOH. Id. at 313. She are not monitored. And that’s kind of the best
In addition to his previous testimony
also maintained that if she had reason answer I can give you. There’s nothing really regarding the various incidents,
to believe that he poses ‘‘an immediate all that magic [sic] about five years. It’s just Respondent admitted that he had
danger to the public health,’’ she would that that’s kind of a standard these days. probably used drugs when he was
also contact the Chief of the DOH’s working. Id. at 216. When asked how
Id. at 325–26.
Prosecutorial Services Unit. Id. at 314. The ALJ then asked Dr. Ziegler what long he would continue to be actively
However, Dr. Ziegler acknowledged that ‘‘it means to represent that someone is monitored, Respondent answered: ‘‘the
in such a scenario, only the DOH has safe to practice?’’ Id. at 326. Dr. Ziegler rest of my life, if it can happen.’’ Id. at
authority to issue an emergency answered: 219; see also id. at 256 (expressing
suspension of Respondent’s medical willingness to sign lifelong PRN
Well, when we make that kind of contract). He further testified that
license. Id. at 321; 323. representation, we’re basing that on reports
When asked (on re-direct during the fourth year of monitoring, he
that we receive from the treating professional
examination) if granting prescribing involved with this person’s individual
would be subject to eighteen urine tests
authority to Respondent would pose situation at the outset and then as we go as well as a hair test every three months,
‘‘any safety issue,’’ Dr. Ziegler testified: along, also with the results of our frequent and that in the fifth year of his PRN
random drug testing and our contact with the contract, he would be subject to twenty-
No. And people at his stage of recovery and
at his point in monitoring with us, lots of
person, mostly over the phone, as they go four urine tests. Id. at 220. However,
those practitioners hold DEA certificates and
through our program. Respondent did not know how many
. . . what I usually say if I’m writing a urine tests would be conducted each
use them in the course of their practice of
letter to the Board of Medicine or to a year if he contracted for additional
medicine. You know, having prescribing
potential employer or to an insurance
privileges, there’s a certain amount of risk monitoring. Id. Respondent then
company or to the DEA is in my professional
associated with it. But at his stage of the acknowledged that both the DOH and
opinion[,] this person is safe to practice with
game it certainly is not something we would this Agency could require that he stay
reasonable skill and safety.
be concerned about because he is doing very in the PRN program. Id. at 221.
I believe that when somebody is in our
well. Respondent also acknowledged that
monitoring program and has done well for a
Id. at 317–18. period of time that they are as safe to practice as an emergency room physician, at
Dr. Ziegler then explained that if with reasonable skill and safety as someone times he did experience ‘‘great stress.’’
Respondent was to obtain employment who has never been identified as having a Id. at 224. Respondent explained,
in an emergency room, the PRN would problem. however, that ‘‘most of the time, I was
‘‘want to have some kind of an Id. at 326–27. able to handle that, and that’s without
understanding with his employer . . . Finally, the ALJ noted that having any knowledge [of] how to do
so that we had permission to talk to Respondent’s PRN contract includes a it.’’ Id. Respondent further agreed that
them if we were concerned or they had provision which states that PRN ‘‘agrees his recovery will be ‘‘a lifelong struggle’’
permission to talk to us if they were to assume an advocacy role with [the] and that he could not guarantee that he
concerned,’’ and that Respondent would Professional Licensing Board, hospital will never relapse. Id. at 225–26. He
have to agree to this before the PRN board, and other appropriate agencies, further testified that he accepted all
would allow him to accept the position. provided the above listed terms are responsibility for ‘‘all of these violations
Id. at 318. And she further testified that agreed to and met.’’ RX B, at 6 that [he] had both as related to
were Respondent to accept a position in (emphasis added). The ALJ then asked controlled substances and the way that
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an emergency room without notifying Dr. Ziegler whether DEA was [he] practice[d] medicine outside . . . of
the PRN, this would constitute a considered to be ‘‘such an agency.’’ Tr. [the] standards of care.’’ Id. at 249.
material breach of the PRN contract and 329. Dr. Ziegler answered:
he would be immediately pulled from DISCUSSION
Well, I’m not wild about that term
practice and required to undergo a new ‘‘advocacy,’’ but I’ll buy it temporarily and Section 303(f) of the Controlled
evaluation. Id. say yes. I mean, advocacy means that we are Substances Act (CSA) provides that
Following questioning by the parties, willing to do something like today . . . . ‘‘[t]he Attorney General may deny an
the ALJ asked Dr. Ziegler ‘‘what You’re having a hearing and I’m willing to application for [a practitioner’s]
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registration . . . if [he] determines that 62884, 62887 (1995). See also Hoxie v. medical purpose by an individual
the issuance of such registration . . . DEA, 419 F.3d at 483 (‘‘admitting fault’’ practitioner acting in the usual course of
would be inconsistent with the public is ‘‘properly consider[ed]’’ by DEA to be his professional practice.’’ 21 CFR
interest.’’ 21 U.S.C. § 823(f). In making an ‘‘important factor[ ]’’ in the public 1306.04(a). The regulation further
the public interest determination, the interest determination). Even so, at all provides that ‘‘an order purporting to be
CSA directs that the following factors be times, the burden of proof on the a prescription issued not in the usual
considered: ultimate issue of whether an applicant’s course of professional treatment . . . is
(1) The recommendation of the registration is inconsistent with the not a prescription within the meaning
appropriate State licensing board or public interest remains with the and intent of [21 U.S.C. 829] and . . .
professional disciplinary authority. Government. 5 U.S.C. § 556(d); 21 CFR the person issuing it, shall be subject to
(2) The applicant’s experience in 1301.44(d). the penalties provided for violations of
dispensing . . . controlled Having considered all of the factors,3 the provisions of law relating to
substances. I hold that the Government has met its controlled substances.’’ Id.
(3) The applicant’s conviction record prima facie burden of showing that As the Supreme Court has explained,
under Federal or State laws relating Respondent has committed acts which ‘‘the prescription requirement . . .
to the manufacture, distribution, or render his registration ‘‘inconsistent ensures patients use controlled
dispensing of controlled substances. with the public interest.’’ 21 U.S.C. substances under the supervision of a
(4) Compliance with applicable State, § 823(f). However, I further find that doctor so as to prevent addiction and
Federal, or local laws relating to Respondent has accepted responsibility recreational abuse. As a corollary, [it]
controlled substances. for his misconduct. Moreover, I hold also bars doctors from peddling to
(5) Such other conduct which may patients who crave the drugs for those
that in the event Respondent produces
threaten the public health and prohibited uses.’’ Gonzales v. Oregon,
evidence that he has continued to
safety. 546 U.S. 243, 274 (2006) (citing United
Id. comply with his PRN contract and has
passed all drugs tests administered to States v. Moore, 423 U.S. 122, 135, 143
‘‘[T]hese factors are . . . considered (1975)); United States v. Alerre, 430
in the disjunctive.’’ Robert A. Leslie, 68 him since January 28, 2014, he will have
produced sufficient evidence of his F.3d 681, 691 (4th Cir. 2005), cert.
FR 15227, 15230 (2003). I may rely on denied, 574 U.S. 1113 (2006) (the
any one or a combination of factors and successful rehabilitation and will have
rebutted the Government’s prima facie prescription requirement stands as a
may give each factor the weight I deem proscription against doctors acting not
appropriate in determining whether to case.
‘‘as a healer[,] but as a seller of wares’’).
deny an application for a registration. Factor Two—Respondent’s Experience Under the CSA, it is fundamental that
Id. Moreover, I am ‘‘not required to in Dispensing Controlled Substances a practitioner must establish and
make findings as to all of the factors.’’ maintain a legitimate doctor-patient
Pursuant to a longstanding agency
Hoxie v. DEA, 419 F.3d 477, 482 (6th relationship in order to act ‘‘in the usual
regulation, ‘‘[a] prescription for a
Cir. 2005); see also Morall v. DEA, 412 course of . . . professional practice’’
controlled substance [is not] effective
F.3d 165, 173–74 (D.C. Cir. 2005). and to issue a prescription for a
The Government has ‘‘the burden of [unless it is] issued for a legitimate
‘‘legitimate medical purpose.’’ Paul H.
proving [by substantial evidence] that 3 As for factor one, the recommendation of the Volkman, 73 FR 30629, 30642 (2008),
the requirements for . . . registration state licensing authority, the DOH has not made a pet. for rev. denied, 567 F.3d 215, 223–
. . . are not satisfied.’’ 21 CFR recommendation to the Agency as to whether 24 (6th Cir. 2009); see also Moore, 423
1301.44(d); see also 5 U.S.C. § 556(d). Respondent should be granted a new DEA
U.S. at 142–43 (noting that evidence
However, where the Government has registration. Moreover, although Respondent is
currently licensed by the State and thus satisfies an established that physician exceeded the
met its prima facie burden of showing essential condition for obtaining a registration, see bounds of professional practice, when
that issuing a new registration to the 21 U.S.C. §§ 802(21) & 823(f), this ‘‘ ‘is not ‘‘he gave inadequate physical
applicant would be inconsistent with dispositive of the public interest inquiry.’ ’’ George examinations or none at all,’’ ‘‘ignored
the public interest, a respondent must Mathew, 75 FR 66138, 66145 (2010), pet. for rev.
denied Mathew v. DEA, No. 10–73480, slip op. at the results of the tests he did make,’’
come forward with ‘‘sufficient 5 (9th Cir., Mar. 16, 2012); see also Patrick W. and ‘‘took no precautions against . . .
mitigating evidence’’ to show why he Stodola, 74 FR 20727, 20730 n.16 (2009); Robert A. misuse and diversion’’). The CSA,
can be entrusted with a new Leslie, 68 FR 15227, 15230 (2003). As the Agency however, generally looks to state law to
registration. Medicine Shoppe- has further held, ‘‘the Controlled Substances Act
requires that the Administrator . . . make an determine whether a doctor and patient
Jonesborough, 73 FR 364, 387 (2008) independent determination [from that made by state have established a legitimate doctor-
(quoting Samuel S. Jackson, 72 FR officials] as to whether the granting of controlled patient relationship. Volkman, 73 FR at
23848, 23853 (2007) (quoting Leo R. substance privileges would be in the public 30642.
Miller, 53 FR 21931, 21932 (1988))). interest.’’ Mortimer Levin, 57 FR 8680, 8681 (1992).
Thus, this factor is not dispositive either for, or
As found above, it is undisputed that
Moreover, because ‘‘ ‘past performance against, the granting of Respondent’s application. Respondent issued multiple
is the best predictor of future Paul Weir Battershell, 76 FR 44359, 44366 (2009) prescriptions for a total of 720 dosage
performance,’ ALRA Labs, Inc. v. DEA, (citing Edmund Chein, 74 FR 6580, 6590 (2007), units of OxyContin 80mg in a manner
54 F.3d 450, 452 (7th Cir.1995), [DEA] pet. for rev. denied Chein v. DEA, 533 F.3d 828 which violated both the CSA’s
(D.C. Cir. 2008)).
has repeatedly held that where a Regarding factor three, there is no evidence that
prescription requirement and Florida
registrant has committed acts Respondent has been convicted of an offense law. As the evidence shows, while
inconsistent with the public interest, the related to the manufacture, distribution or Respondent wrote the prescriptions for
dispensing of controlled substances. However, as
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registrant must accept responsibility for his girlfriend, and maintained that he
there are a number of reasons why a person may
[his] actions and demonstrate that [he] never be convicted of an offense falling under this
had done so because she had re-injured
will not engage in future misconduct.’’ factor, let alone be prosecuted for one, ‘‘the absence her neck while snowboarding on a ski
Medicine Shoppe, 73 FR at 387; see also of such a conviction is of considerably less trip, he admitted that shortly after
Jackson, 72 FR at 23853; John H. consequence in the public interest inquiry’’ and returning from the trip, he had changed
thus, it is not dispositive. David A. Ruben, 78 FR
Kennedy, 71 FR 35705, 35709 (2006); 38363, 38379 n. 35 (2013) (citing Dewey C. MacKay,
her prescription from hydrocodone to
Cuong Tron Tran, 63 FR 64280, 64283 75 FR 49956, 49973 (2010), pet. for rev. denied OxyContin so that he could obtain the
(1998); Prince George Daniels, 60 FR MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)). drugs to abuse them and that he took
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some portion of the OxyContin he noncompliance with law but still suggests paraphernalia ‘‘[t]o inject . . . a
prescribed. Tr. 205 & 207. experience that may threaten the public controlled substance in violation of this
An expert retained by the DOH found interest. There is, for example, no law against chapter’’); id. § 893.145(11) (defining
that Respondent did not maintain being familiar with that part of society that drug paraphernalia as including
deals in illicit drug trafficking. Over the years
medical records, that there was no ‘‘[h]ypodermic syringes, needles, and
while he was buying heroin and other drugs
evidence that he had assessed his on the street, [Respondent] has become very other objects used, intended for use, or
girlfriend’s medical problems and that well acquainted with those in the community designed for use in parenterally
his diagnosis was ‘‘inappropriate and who have chosen to traffic in heroin. A injecting controlled substances into the
inadequate.’’ GX 8, at 2. The DOH’s person with that kind of experience, human body’’).
expert also found that Respondent had particularly one authorized to write So too, because Respondent did not
not created a treatment plan. The DOH’s prescriptions for narcotics and other obtain the OxyContin he admitted to
expert thus concluded that controlled substances, holds a highly abusing ‘‘pursuant to a valid
Respondent’s prescribing ‘‘fell well valuable key recognized by those in our prescription from a practitioner,’’ or
below the standard of care as defined society who are likely to try to exploit that obtain it in a manner otherwise
authority to advance their own illicit goals.
by’’ both state and national norms and authorized by the CSA, he also
Restoring to [Respondent] the ability to
that he committed ‘‘egregious error’’ by prescribe controlled substances carries with unlawfully possessed those drugs. 21
prescribing to ‘‘an intimate partner . . . it some risk, given the unique skill set U.S.C. § 844(a); see also Fla. Stat.
over a prolonged period.’’ Id. Moreover, [Respondent] developed while seeking § 893.13(6)(a). Likewise, at the time of
Respondent fully admitted that he did heroin and other addictive drugs on the the 2011 Tampa Airport incident,
not have a proper medical justification street. While he may well be able to resist Respondent was in found to be in
to prescribe to his girlfriend and that the efforts from those in the trafficking trade to possession of heroin, methadone, and
prescriptions were issued outside of the recruit him during periods of sustained stable Xanax (alprazolam), as well as multiple
usual course of professional practice. recovery, were he to relapse those illicit syringes.
I therefore find that Respondent efforts may well prove successful, creating a Heroin is a schedule I drug, as it has
violated both the CSA’s prescription significant risk of prescription drug no accepted medical use; Respondent
diversion.
regulation, see 21 CFR 1306.04(a), and thus had no authority to possess the
Florida law, which prohibits the R.D. at 37–38. drug under his registration. See 21 CFR
prescribing of ‘‘any controlled The ALJ’s reasoning finds no warrant 1308.11(c); GX 2, at 3; 21 U.S.C.
substance, other than in the course of in the text of Factor Two. Contrary to § 822(b). Nor did Respondent dispute
the physician’s professional practice.’’ the ALJ’s understanding, factor two does that he did not have prescriptions for
Fla. Stat. § 458.331(1)(q); see also 21 not call for an inquiry into a the methadone and Xanax. Thus, here
U.S.C. § 841(a)(1) (‘‘[e]xcept as practitioner’s life experience generally again, Respondent violated the CSA and
authorized by this subchapter, it shall or even his experience related in any Florida law by unlawfully possessing
be unlawful for any person knowingly manner to controlled substances, but controlled substances. 21 U.S.C.
or intentionally . . . to dispense . . . a rather, only his ‘‘experience in § 844(a); see also Fla. Stat.
controlled substance’’). dispensing, or conducting research with § 893.13(6)(a). Moreover, his possession
Against this evidence, Respondent respect to controlled substances.’’ See of the syringes also violated Florida law.
testified as to the training he received in 21 U.S.C. § 823(f)(2). While writing Fla. Stat. § 893.147 (prohibiting the
his residency regarding the dispensing controlled substance prescriptions possession, with intent to use, of drug
of controlled substances, his more than which were then traded for street drugs paraphernalia); id. § 893.145(11).
twenty years of experience in would clearly be actionable misconduct Here again, Respondent does not
dispensing controlled substances as an under this factor, there is not even an dispute that he engaged in the above
emergency room physician, and there is iota of evidence in this record that acts. Respondent’s extensive record of
no evidence that he has otherwise Respondent ever traded controlled non-compliance with the CSA and
knowingly diverted controlled substance prescriptions for drugs he Florida laws related to controlled
substances. He also testified that obtained on the street. In the absence of substances thus provides further
pursuant to the DOH’s order, he had any such evidence, the ALJ’s reasoning support for the conclusion that the
taken a course on the proper prescribing is nothing more than unsupported Government has established a prima
of controlled substances. speculation. Accordingly, I reject it. facie case to deny his application.
Be that as it may, the finding that he Factor Five—Such Other Conduct
violated both the CSA and federal law Factor Four—The Applicant’s Which May Threaten Public Health and
in issuing the OxyContin prescriptions Compliance With Applicable Laws Safety
is evidence of his experience in Related To Controlled Substances DEA precedent has long recognized
dispensing controlled substances even if In addition to the prescribing that a practitioner’s self-abuse of
it is also evidence of his noncompliance violations discussed above, Respondent controlled substances constitutes
with applicable laws related to committed additional violations of both misconduct which is actionable under
controlled substances. And by itself, the CSA and Florida laws when he this factor. Tony T. Bui, 75 FR 49979,
this finding is sufficient to support the unlawfully possessed controlled 49989 (2010) (citing, inter alia, David E.
conclusion that the Government has substances and drug paraphernalia. Trawick, 53 FR 5326, 5327 (1988);
established a prima facie case to deny With respect to the 2003 incident, William H. Carranza, 51 FR 2771
Respondent’s application. I thus reject Respondent clearly possessed heroin (1986)). Here, it is undisputed that
the ALJ’s conclusion that factor two
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and drug paraphernalia (i.e., a syringe) Respondent has a long and disturbing
‘‘neither supports nor contradicts’’ when he injected himself with the history of abusing controlled
Respondent’s application. heroin. Respondent’s conduct violated substances. Moreover, Respondent
The ALJ’s analysis of Factor Two both the CSA, see 21 U.S.C. § 844(a) admitted that he had probably been
nonetheless warrants further discussion. (simple possession), as well as Florida under the influence of controlled
More specifically, the ALJ opined that: law. See Fla. Stat. § 893.13(6)(a) substances while at work. This factor
[T]here also is evidence of acts by (unlawful possession); id. thus provides further support for the
[Respondent] that do not constitute § 893.147(1)(b) (prohibiting use of drug Government’s prima facie case.
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The ALJ further found that beyond The evidence does not, however, thus admitted to having committed
this evidence, Respondent, when ‘‘not support either the ALJ’s conclusion that egregious misconduct. Viewed in this
in stable and sustained recovery . . . he lied to the Florida Department of context, his answer to the Government’s
has a demonstrated tendency towards Health because he failed to disclose to subsequent question, which asked if
lying in the course of responding to it that he was using the OxyContin he there was ‘‘any part of’’ the report that
governmental processes.’’ R.D. 40. As prescribed to B.B. or the ALJ’s he did ‘‘not agree’’ with, and to which
support for his conclusion, the ALJ suggestion that he gave false testimony he answered, ‘‘No. It’s 100 percent
explained that ‘‘[h]is decision to deny in this proceeding. As for the former, accurate,’’ cannot reasonably be
his possession of heroin when there is no evidence that Respondent construed as false.4
interviewed by a court evaluator was ever asked by the DOH’s Accordingly, I reject the ALJ’s
following his 2003 overdose is one investigator whether he was using the analysis that Respondent has
example; his failure to disclose to the OxyContin and Respondent testified demonstrated a pattern of misleading
Florida Department of Health that he that ‘‘[n]obody from the [DOH] asked, governmental officials when his
was diverting OxyContin for his own and I didn’t volunteer that information.’’ substance abuse ‘‘created significant
use in 2006 is another example.’’ Id. Tr. 204. Thus, Respondent did not lie to problems for’’ him. R.D. at 41. However,
The ALJ then suggested that the DOH. To the extent the ALJ’s his substance abuse alone supports a
Respondent gave false testimony in this conclusion rests on the theory that finding that he has engaged in conduct
proceeding. More specifically, the ALJ Respondent misled the DOH by failing which may threaten public health and
reasoned that: disclose to it that he was using the safety.
OxyContin, the Government made no Summary
Further, his testimony in these such argument and the ALJ cited no
proceedings, to the effect that the expert As found above, the Government’s
authority for the proposition that
evaluation presented to the Florida [DOH] in evidence with respect to factors two,
2005 by [its] expert was ‘‘100 percent
Respondent had a duty under Florida
law to disclose this information to the four and five, establishes that
accurate’’ cannot be reconciled with the fact
DOH. Respondent wrote unlawful
that [the expert’s] report made no mention of
the whole truth here—that [he] had been So too, I find unwarranted the ALJ’s prescriptions, unlawfully possessed
diverting [his girlfriend’s] OxyContin for his suggestion that Respondent gave false controlled substances, unlawfully
own use, for two years. Dr. Greenstein’s testimony when he testified that the possessed drug paraphernalia, and has a
report was not ‘‘100 percent accurate,’’ and DOH expert’s report was ‘‘100 percent long history of substance abuse.
it was inaccurate with respect to a material accurate.’’ R.D. at 40. While the ALJ Accordingly, the Government has
condition that apparently has never been reasoned that the expert’s ‘‘report was established a prima facie case to deny
disclosed to the Florida medical authorities. not ‘100 percent accurate’ ’’ because it Respondent’s application on the ground
Id. ‘‘made no mention of the whole truth,’’ that his registration ‘‘would be
that being that Respondent was using inconsistent with the public interest.’’
However, the ALJ then explained that 21 U.S.C. 823(f). Indeed, in his post-
‘‘that the evidence does not compel, or his girlfriend’s OxyContin, there is no
evidence that the expert ever hearing brief, Respondent concedes as
even permit, a finding that [Respondent] much.
interviewed Respondent. Indeed, the
currently presents a threat to the public
expert’s report stated that he had only SANCTION
due to a predisposition to prevaricate.’’
reviewed the investigative file prepared
Id. at 41. The ALJ further explained that As explained above, where the
by the DOH.
he did ‘‘not detect a present threat Moreover, the ALJ’s suggestion cannot Government has met its prima facie
here,’’ as he believed that Respondent be sustained upon reviewing the burden of showing that issuing a new
‘‘can be relied upon to be forthright and entirety of Respondent’s testimony registration to the applicant would be
candid during his recovery.’’ Id. regarding the DOH expert’s report. Cf. inconsistent with the public interest, a
(emphasis added). Nonetheless, because Meyers v. United States, 171 F.2d 800, respondent must come forward with
Factor Five directs that the Agency 806–07 (D.C. Cir. 1948) (a ‘‘statement ‘‘ ‘ ‘‘sufficient mitigating evidence’’ ’ ’’ to
consider ‘‘conduct which may threaten may not be isolated and thereby given show why he can be entrusted with a
the public health and safety,’’ the ALJ a meaning wholly different from the new registration. Medicine Shoppe-
then reasoned that ‘‘[a] chronic history clear significance of the testimony Jonesborough, 73 FR 364, 387 (2008)
of substance abuse, coupled with a considered as a whole’’). As found (quoting Samuel S. Jackson, 72 FR
pattern of misleading governmental above, Respondent answered 23848, 23853 (2007) (quoting Leo R.
officials when the abuse created ‘‘absolutely’’ when asked by the Miller, 53 FR 21931, 21932 (1988))).
significant problems for [him], is Government whether he agreed with the ‘‘Moreover, because ‘past performance is
evidence of conduct that may threaten expert’s conclusions. Tr. 203. Notably, the best predictor of future
public health and safety.’’ Id. (emphasis those conclusions included that there performance,’ ALRA Labs, Inc. v. DEA,
added). was no evidence that he had assessed 54 F.3d 450, 452 (7th Cir.1995), [DEA]
As stated above, I agree with the ALJ B.B.’s medical problems and that his has repeatedly held that where a
that the evidence shows that ‘‘diagnosis was therefore inappropriate registrant has committed acts
Respondent has a chronic history of and inadequate’’; that his ‘‘care fell well inconsistent with the public interest, the
substance abuse. However, I reject his below the standard of care as defined by registrant must accept responsibility for
conclusion that the evidence establishes Florida statute, local and national [his] actions and demonstrate that [he]
will not engage in future misconduct.’’
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that Respondent has ‘‘a demonstrated norms’’; that the ‘‘prescription of
tendency towards lying’’ to government OxyContin was strikingly Medicine Shoppe, 73 FR at 387; see also
officials and a ‘‘pattern of misleading’’ inappropriate’’; that he committed an Jackson, 72 FR at 23853; John H.
them. To be sure, the evidence shows ‘‘egregious error’’ by providing ‘‘high-
4 Indeed, while the ALJ reasoned that the report
that in 2003, Respondent falsely stated volume, long duration’’ prescriptions
was not 100 percent accurate because it made no
to the evaluator for the pretrial drug ‘‘of a highly abused narcotic to a patient mention of Respondent’s diverting the drugs to his
intervention program that the heroin with whom he had an intimate own use, there is not a single statement in the
found in his vehicle was not his. relationship.’’ GX 8, at 2-3. Respondent report which appears to be untrue.
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Kennedy, 71 FR 35705, 35709 (2006); of factors present in any self-abuse case To be sure, Dr. Ziegler testified that
Prince George Daniels, 60 FR 62884, which support a finding that a PRN contracts ‘‘used to be three years’’
62887 (1995). See also Hoxie v. DEA, practitioner continues to poses an but were ‘‘extended to five years
419 F.3d at 483 (‘‘admitting fault’’ is unacceptable risk of relapse (even after because . . . some research studies . . .
‘‘properly consider[ed]’’ by DEA to be completing multiple years of sustained showed that three years may not be long
an ‘‘important factor[]’’ in the public recovery), a categorical rule that a enough and that relapses did frequently
interest determination). practitioner cannot be registered before occur at the three-year point.’’ Tr. 325–
Here, the ALJ found that Respondent completing five years in a PRN program 26. However, even assuming that these
has accepted responsibility for his is inherently arbitrary. studies involved physicians who were
misconduct. R.D. at 42. However, the Contrary to the ALJ’s reasoning, still subject to PRN monitoring at the
ALJ concluded that Respondent has not neither the testimony of Dr. Myers nor time of their relapses, no further
produced sufficient evidence of his Dr. Ziegler ‘‘established [that] a material testimony was elicited from Dr. Ziegler
rehabilitation to rebut the Government’s risk of relapse exists during the first five as to what the actual rate of relapse was
prima facie case. Id. As the ALJ years of stable recovery’’ for either at three years and various times
explained: professionals generally or Respondent thereafter.6
specifically. Indeed, in concluding that In short, neither the testimony of Dr.
The record before me establishes that when
sober and compliant with his recovery Respondent continues to present an Myers nor of Dr. Ziegler establishes
program, [Respondent] can be relied upon to unacceptable risk of relapse and will do what the relapse rate is for physicians
avoid engaging in behavior that threatens the so until he completes a full five years in who remain subject to monitoring
public interest. Thus, the risk of relapse the PRN program, the ALJ ignored during the fourth and fifth years of a
becomes critical in determining what steps extensive evidence offered by PRN contract as a general matter, let
are warranted when determining the public Respondent to the contrary. alone for physicians who present
interest. Here, testimony from Drs. Ziegler particular risk factors for relapse. And
As found above, Dr. Myers testified
and Myers establishes that the risk of relapse in any event, Respondent is now well
is high, and will continue to be high for that the PRN initially used ‘‘a two-year
contract’’ but found that ‘‘too many docs past three years of successful
[Respondent], throughout the five years
and . . . healthcare professionals [were] compliance with his PRN contract and
following the commencement of his recovery.
The evidence fully supports a finding that relapsing following the two years.’’ Tr. through the closing of the record, he has
[Respondent’s] recovery since February 2011 147. He then explained that PRN passed every drug test since seeking
has been stable and successful. The evidence lengthened the contract term to five treatment in February 2011.
also supports a finding, however, that years because ‘‘studies suggest’’ that five Moreover, both Dr. Myers and Ziegler
insufficient time in stable recovery has years ‘‘is a solid recovery time’’ which offered extensive evidence of
passed to support a finding that corrective
provides ‘‘maximum benefit’’ and that Respondent’s commitment to his
action has been taken. . . . Surely steps that recovery and compliance with his PRN
may lead to effective corrective action have ‘‘the percentage of relapse is very low’’
contract. Yet this evidence is barely
begun, but those steps are not complete, and for those persons who complete the five-
acknowledged in the recommended
in the absence of evidence of complete year contract. Id.
decision. Notably, Dr. Myers, who, in
corrective actions the Respondent has not, by Notably, Dr. Myers did not testify as
addition to being a Diplomate of the
a preponderance, presented evidence that to the specific relapse rate of those
would permit the restoration of his . . . American Board of Addiction Medicine
doctors who had completed a two-year
[r]egistration. and a Fellow of the American Society of
contract. Most significantly, his
Addiction Medicine, has twenty-five
Id. at 42–43. testimony suggests only that the relapse
years of experience working with
I do not dispute the ALJ’s premise rate was unacceptably high for those
chemically dependent persons, with
that ‘‘the risk of relapse [is] critical in doctors who had completed their two- twenty of those years focused on
determining what steps are warranted’’ year contracts and were no longer recovering professionals, testified that
to protect the public interest. I reject, subject to monitoring and other contract he employs Respondent in his practice,
however, the ALJ’s conclusion that until requirements. This, of course, says that he considers him safe, and that if
Respondent successfully completes a nothing about the relapse rate of those he had ‘‘any doubt that [Respondent]
full five years in the PRN’s program, he doctors who continued to be subject to was risky, he couldn’t use him.’’ Tr. at
presents an unacceptable risk of relapse. monitoring after completing a two-year 133. Dr. Myers also testified that while
Not only does the ALJ’s conclusion rest contract. Respondent will never be cured, he
on a misreading of the testimony of both As for Dr. Myers’ further testimony believes that Respondent is fully
Drs. Myers and Dr. Ziegler, it cannot be that various studies suggests that five committed to his recovery, that he ‘‘is
reconciled with numerous agency years ‘‘is a solid recovery time’’ which making it’’ and that he will ‘‘continue to
precedents which have granted new provides ‘‘maximum benefit’’ and that make it.’’ Id. at 132.
registrations to self-abusing the ‘‘percentage of relapse is very low’’ Dr. Ziegler, who is board certified in
practitioners who have undergone for those persons who complete a five- Psychiatry and Addiction Psychiatry, as
treatment and demonstrated year contract, while this explains why well as Addiction Medicine, and has
rehabilitation well before completing PRNs have lengthened their contracts to focused her professional activities on
five years of treatment in a PRN five years, it too says nothing about the the treatment of addiction, testified that
program.5 While there may be a variety actual risk of relapse for those
physicians who remain subject to, and 6 The conclusion that because PRN programs have
5 See Perry T. Dobyns, 77 FR 45656 (2012) in compliance with, a PRN contract extended their monitoring contracts to five years, a
mstockstill on DSK4VPTVN1PROD with NOTICES
(granting restricted registration based on less than through years three, four, and five of physician under such a contract invariably presents
three years of demonstrated sobriety following an unacceptable risk of relapse until he completes
physician’s relapse); Stephen Reitman, 76 FR 60889
their contracts. a full five years of compliance, was refuted by Dr.
(2011) (granting restricted registration where Ziegler’s testimony. See Tr. 317–18. The Agency’s
evidence at hearing established only one year of Karen Kruger, 69 FR 7016 (2004) (granting case law also suggests that this conclusion is
sobriety); Michael Moore, 76 FR 45867 (2011) registration after three and a half years of inconsistent with the understanding of state
(suspending but not revoking registration where demonstrated sobriety); Jimmy H. Conway, Jr., 64 medical boards, which have frequently issued new
physician, who abused marijuana, had FR 32271 (1999) (granting registration after three licenses to practitioners before the practitioners
demonstrated sobriety for less than four years); years of demonstrated sobriety). have demonstrated five years of sobriety.
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![53202 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices
Respondent has passed all of his urine denied because he failed to produce retains the burden of proving that
screens and ‘‘has been entirely evidence supporting his application granting his application is inconsistent
compliant with his contract.’’ Tr. 312. In ‘‘from independent medical with the public interest. 5 U.S.C. 556(d);
his decision, the ALJ asserted that, professionals.’’ Gov. Br. 20. It is not 21 CFR 1301.44(d). Accordingly, I reject
because the PRN contract obligates the entirely clear what, in the Government’s the Government’s contention that
PRN ‘‘to assume an advocacy role’’ with view, qualifies a medical professional as Respondent presents an unacceptable
licensing agencies provided Respondent ‘‘independent.’’ However, in self-abuse risk of relapse until he successfully
complied with the terms of his contract, cases, this Agency has never required a completes a full five years in the PRN
her testimony ‘‘should be treated as practitioner to present evidence from a program.
advocacy, rather than as independent medical professional who either does I therefore conclude that provided
and unbiased medical testimony.’’ R.D. not have a doctor-patient relationship Respondent has continued to comply
at 32. However, Dr. Ziegler further with the physician or is not otherwise with his PRN contract and has passed
explained that PRN will ‘‘withdraw our involved in the physician’s recovery.8 all drug tests since the closing of the
advocacy if the person no longer Rather, the Agency has frequently record, he is entitled to be registered.
warrants that advocacy.’’ Tr. 330. granted new registrations to Accordingly, Respondent is directed to
Accordingly, I do not find that the practitioners based on the reliable provide evidence of all drug test results
existence of the PRN contractual testimony of treating professionals. To conducted since January 28, 2014 and
provision warrants giving less than full the extent the Government believes that his continued compliance with his PRN
weight to her testimony.7 neither Dr. Myers nor Dr. Ziegler were contract.9 In the event Respondent has
While Dr. Ziegler testified that she objective witnesses in their assessments failed any of the drug tests, or has not
could not guarantee that Respondent of Respondent’s risk of relapse, it bears remained in compliance with his PRN
would never relapse, she also testified noting that there is independent contract, his application shall be
that granting Respondent prescribing medical evidence of Respondent’s denied. In the event he has passed all
authority would not pose a safety issue. successful rehabilitation—this being the of these tests and remained in
As she explained: numerous random drug tests he has compliance, he shall be granted a
people at his stage of recovery and at his passed. And nothing prevented the registration, subject to the following
point in monitoring with us, lots of those Government from retaining an expert conditions which are supported by the
practitioners hold a DEA certificate and use who could have reviewed Respondent’s
them in the course of their practice of record.
medicine. . . . [H]aving prescribing
treatment records and rendered an First, the Government notes that
privileges, there’s a certain amount of risk opinion on whether he presents an Respondent can walk away from his
associated with it. But at this stage of the unacceptable risk of relapse. PRN contract at any time. While there
game it certainly is not something we would The Government also argues that is evidence that in the event Respondent
be concerned about because he is doing very because of ‘‘his long-term drug abuse,’’ were to do so, the PRN would report
well. Respondent should not be granted a him to the DOH, the record does not
Tr. 317–18. registration until he has completed a establish what action the DOH would
Dr. Ziegler also testified that when minimum of ‘‘five years of monitored take in response. Accordingly, I
PRN represents to a licensing body that treatment.’’ Gov. Br. at 19. Notably, the conclude that Respondent’s registration
a practitioner is safe to practice, its Government produced no evidence shall be conditioned on his remaining in
representation is based on the reports it establishing that physicians with a long compliance with his PRN contract. In
has received from the physician’s history of abuse have a greater risk of the event Respondent fails to comply
treating professional who is aware of the relapse than other physicians. Indeed, with his PRN contract, his registration
physician’s individual situation, the when asked by the Government whether shall be subject to an Immediate
results of the random drugs screens it there is a correlation between a Suspension Order.
has conducted, and its contact with the physician’s length of abuse and the Second, while Respondent’s PRN
physician as he/she goes through the likelihood of relapse, Dr. Myers testified contract expires in May 2016, Dr.
program. Id. at 326–27. And she further that while ‘‘there are a number of factors Ziegler noted that PRN offers its clients
testified ‘‘that when somebody is in our which can help predict relapses,’’ he a licensure-long contract. Moreover, in
monitoring program and has done well did not believe that a correlation has his testimony Respondent
for a period of time [he/she is] as safe been established between the length of acknowledged that his recovery will be
to practice with reasonable skill and abuse and the likelihood of relapse. ‘‘a lifelong struggle’’ and expressed a
safety as someone who has never been The Government offered no evidence willingness to enter into a licensure-
identified as having a problem.’’ Id. at to refute this testimony. Moreover, long contract; he also acknowledged
327. while Dr. Myers testified that there are that DEA could require that he stay in
The Government also argues that a number of factors that predict the PRN program. Accordingly, I
Respondent’s application should be relapses, the Government did not elicit conclude that Respondent’s registration
any testimony from Dr. Myers or offer shall be conditioned on his entering into
7 Notably, other than the contractual provision, any other evidence establishing what a licensure-long contract upon the
there is no evidence on Dr. Ziegler’s part of the those factors are and whether they are completion of his initial five-year
existence of any other of the typical sources of present in Respondent’s case.
partiality. contract. Moreover, if, following the
It bears noting that while Respondent
Of further note, neither the Government nor the completion of his initial five-year
ALJ identify a specific instance in which Dr. had the burden of producing sufficient
contract, Respondent fails to enter into
mstockstill on DSK4VPTVN1PROD with NOTICES
Ziegler’s testimony lacked objectivity. evidence to establish that he has
a licensure-long contract, his
As for Dr. Myers, the Government argues that his undertaken sufficient corrective
testimony should be given ‘‘the same scrutiny as Dr. measures such that he is not likely to re-
Ziegler[’s]’’ because he has a long association with 9 Respondent shall provide this evidence to the
PRN and ‘‘should be viewed as an agent of PRN.’’ offend, the Government, at all times, Office of the Administrator no later than thirty (30)
Gov. Br. at 21–22. Here again, I find the days from the date of this Order. Respondent shall
Government’s argument unpersuasive and do not 8 It is far from clear whether, under Florida law, also provide a copy of his filing to Government
find that any portion of his testimony lacks Dr. Ziegler, as PRN program director, has a doctor- counsel. In the event Respondent fails to comply,
credibility. patient relationship with the PRN’s clients. his application will be denied.
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![Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices 53203
registration shall be subject to an contract, his application shall be nominations for the 2014–2015 Medal of
Immediate Suspension Order. granted subject to the conditions set Valor, and to make a limited number of
Third, Respondent may not accept forth above. I further order that in the recommendations for submission to the
any position as a physician without first event Respondent has not passed all U.S. Attorney General. Additional
obtaining approval of the PRN program. drug tests since January 28, 2014 or issues of importance to the Board will
Respondent’s acceptance of a position other remained in compliance with his also be covered, to include but not
without first obtaining the PRN’s PRN contract, or fails to submit this limited to a discussion about the
approval shall subject his registration to evidence within the time set forth pending presentation ceremony to
suspension or revocation. above, his application shall be denied. recognize and award the 2013–2014
Fourth, Respondent shall enter into This Order is effective immediately. Medal of Valor to those recipients.
an agreement with the PRN pursuant to Date: May 15, 2015 This meeting is open to the public at
which he authorizes and directs the the Office of Justice Programs. For
Michele M. Leonhart,
PRN to report the results of any drug security purposes, members of the
test he fails to the nearest DEA Field Administrator.
public who wish to participate must
Division Office; a copy of this agreement [FR Doc. 2015–21732 Filed 9–1–15; 8:45 am] register at least seven (7) days in
must be provided to the DEA Field BILLING CODE 4410–09–P advance of the meeting/conference call
Division Office prior to the issuance of by contacting Mr. Joy. All interested
the registration. In the event Respondent participants will be required to meet at
is ordered to undergo a drug test and DEPARTMENT OF JUSTICE the Bureau of Justice Assistance, Office
fails to comply in accordance with the of Justice Programs; 810 7th Street NW.,
PRN’s rules, this shall be deemed a Office of Justice Programs Washington, DC and will be required to
failed test. In the event Respondent fails [OJP (OJP) Docket No. 1695] sign in at the front desk. Note: Photo
any drug test, his registration shall be identification will be required for
subject to an Immediate Suspension Meeting of the Public Safety Officer admission. Additional identification
Order. Medal of Valor Review Board documents may be required.
Respondent is prohibited from Access to the meeting will not be
possessing any controlled substances AGENCY: Bureau of Justice Assistance, allowed without prior registration.
except for those he obtains pursuant to Justice. Anyone requiring special
a lawful prescription or which are ACTION: Notice of meeting. accommodations should contact Mr. Joy
lawfully dispensed to him by a duly SUMMARY: This is an announcement of a at least seven (7) days in advance of the
authorized health care provider. meeting (in-person and virtual) of the meeting. Please submit any comments
Respondent shall not order any Public Safety Officer Medal of Valor or written statements for consideration
controlled substances, nor accept any Review Board, primarily intended to to the Review Board in writing at least
controlled substances (including consider nominations for the 2014–2015 seven (7) days in advance of the meeting
manufacturer’s samples) from any Medal of Valor. Additional issues of date.
person (other than those which are importance to the Board will also be Gregory Joy,
lawfully dispensed to him), including a discussed, to include but not limited to
manufacturer’s or distributor’s sales Policy Advisor/Designated Federal Officer,
a discussion about the pending Bureau of Justice Assistance.
representative. Moreover, Respondent presentation ceremony to recognize and
shall not be authorized to administer [FR Doc. 2015–21565 Filed 9–1–15; 8:45 am]
award 2013–2014 Medal of Valor to the BILLING CODE 4410–18–P
controlled substances to any person recipients. The meeting/conference call
until such time as PRN approves such date and time is listed below.
activity; upon such approval, DATES: September 22, 2015, 9:00 a.m. to
Respondent shall be authorized to DEPARTMENT OF LABOR
12:30 p.m. (EST).
possess such controlled substances. In
ADDRESSES: This meeting will be held at Office of the Secretary
the event Respondent violates the
the Office of Justice Programs, and will
provisions of this paragraph, his Agency Information Collection
also support participation of Member(s)
registration shall be subject to an Activities; Submission for OMB
via conference call-in.
Immediate Suspension Order. Review; Comment Request; Weekly
If PRN approves Respondent to FOR FURTHER INFORMATION CONTACT:
Gregory Joy, Policy Advisor, Bureau of Claims and Extended Benefits Data
engage in the administration of
Justice Assistance, Office of Justice and Weekly Initial and Continued
controlled substances, Respondent shall
Programs, 810 7th Street NW., Weeks Claimed
provide a copy of a letter from PRN to
this effect to the nearest DEA Field Washington, DC 20531, by telephone at
ACTION: Notice.
Division Office prior to engaging in such (202) 514–1369, toll free (866) 859–
activity. 2687, or by email at Gregory.joy@ SUMMARY: The Department of Labor
usdoj.gov. (DOL) is submitting the Employment
ORDER and Training Administration (ETA)
SUPPLEMENTARY INFORMATION: The
Pursuant to the authority vested in me Public Safety Officer Medal of Valor sponsored information collection
by 21 U.S.C. 823(f) and 28 CFR 0.100(b), Review Board carries out those advisory request (ICR) titled, ‘‘Weekly Claims and
I order that the application of Abbas E. functions specified in 42 U.S.C. 15202. Extended Benefits Data and Weekly
mstockstill on DSK4VPTVN1PROD with NOTICES
Sina, M.D., for a DEA Certificate of Pursuant to 42 U.S.C. 15201, the Initial and Continued Weeks Claimed,’’
Registration as a practitioner, be, and it President of the United States is to the Office of Management and Budget
hereby is, held in abeyance pending his authorized to award the Public Safety (OMB) for review and approval for
submission of all drug test results since Officer Medal of Valor, the highest continued use, without change, in
January 28, 2014. I further order that in national award for valor by a public accordance with the Paperwork
the event Respondent has passed all safety officer. Reduction Act of 1995 (PRA), 44 U.S.C.
drug tests since January 28, 2014 and The purpose of this meeting/ 3501 et seq. Public comments on the
remained in compliance with his PRN conference call is primarily to consider ICR are invited.
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Document Created: 2018-02-26 10:10:34
Document Modified: 2018-02-26 10:10:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | May 15, 2015 Michele M. Leonhart, Administrator. | |
| FR Citation | 80 FR 53191 |
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